Aemetis (AMTX): Solvency Concerns And An Upcoming Equity Offering

Summary

  • Aemetis now has over $90 million in short term debts coming due but only $4.7 million in cash. The company has already begun defaulting on its short term debts.
  • This short term nature is not reflected in the recent 10Q due to an accounting technicality that has been missed. More serious accounting issues may have also been missed.
  • Creditors have already assumed as collateral ALL of Aemetis’ assets and are now sweeping cash from Aemetis every night. Creditors are attempting to seize assets.
  • Aemetis recently filed a $100 million S3 and retained an investment bank to advise on financing. A massive near term equity offering is the only option for Aemetis.
  • With share price falling and no other options, the stock could enter a “death spiral” and decline by 50-80%. Past fraud charges for CEO could exacerbate equity discount.

Investment overview

Aemetis Inc (NASDAQ:AMTX) is a company which is totally off the radar for most investors. The company only recently uplisted to the NASDAQ from the OTC BB and has no institutional following. As a result, the mostly retail investor base has missed some critical issues with the company.

Between May and July, shares of Aemetis rose from $5.00 to over $12.00. But now the shares have been dropping daily. Even though earnings on August 7th were relatively positive, the shares have fallen by 20% since then and are already down by more than 30% in just three weeks.

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The reason that the positive earnings did not cheer the stock is because Aemetis is very deeply in debt and is already defaulting on obligations in both the US and India. Creditors have already taken 100% of the cash generated by Aemetis this year and are first in line to take anything else that Aemetis can make. Creditors are already attempting to seize assets.

It is clear that Aemetis must issue a massive amount of new stock to pay creditors and it must do so quickly. Aemetis has over $90 million in short term debt coming due and only $4.7 million in cash.

Aemetis has already filed an S3 registration statement to raise up to $100 million and has engaged an investment bank to help with financing. The equity offering will put extreme pressure on the share price. This is what is driving the share price down.

Because Aemetis MUST complete a financing regardless of price and because of the urgency, the share price will continue to fall sharply. No one wants to be the last one holding shares when the company conducts a huge equity offering.

The shares could fall by a further 50-80% due to the “death spiral” nature of this financing situation. Past examples will illustrate this problem clearly and why it applies to Aemetis.

Again, the reason that the market has missed this is simply because:

a) Aemetis is an under followed stock

b) Aemetis is mostly held by retail and has no legitimate research coverage

c) Aemetis only recently uplisted to the NASDAQ from the OTC BB

Background

In 2013, I wrote an article describing a “death spiral” at Biolase Inc. (NASDAQ:BIOL) which saw the stock plunge by 80% in a week. The situation was very similar to what we are starting to see now with Aemetis.

In early 2013, the Biolase share price was quite strong and traded as high as $6.00. In August 2013, Biolase had just reported earnings and reported a very mild miss. It certainly should not have been a big deal. But still, the share price plunged by 25% that day. The death spiral had already begun….however, many investors had not yet realized it.

By the time I could finish my article within a few days, the stock had already fallen by 50%. Despite this massive drop in less than a week, I still predicted even further declines. The stock then fell an additional 30% on the day of my article alone.

With the stock down 80% in a week, Biolase took the unusual step of halting their own stock when it hit $1.16, down from $3.60 before earnings. It was an epic plunge in just days, and a far cry from $6.00 just weeks earlier.

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Biolase was ultimately able to stabilize and raise some of the money it needed. The stock has recovered to around $2.00, still down by 45% from where it was before.

Biolase offers a good lesson in what triggers a death spiral. Biolase was in violation of its loan covenants and needed to raise money urgently. Issuing stock was the only option and investors could plainly see that Biolase had filed a large S3 registration statement to sell stock. The situation with Aemetis is nearly identical, except that Aemetis has far more debt that Biolase.

In general, a death spiral will occur when a company needs to pay a fixedobligation (ie. debt) and when it must use a variable number of shares to do so. Investors know that the stock will fall upon the equity offering, so they sell and the share price falls. But then the subsequent investors know that the equity offering has not yet happened, so they know that the stock will continue to fall further. They sell, the stock falls, and the cycle repeats again.

No one wants to get caught holding the stock because it is pre-determined that it will continue falling by even more. As the share price gets lower and lower, the relative dilution becomes larger and larger, which then exacerbates the share price decline even more.

As with Biolase, Aemetis Inc is now facing a death spiral situation, and for very similar reasons. And as with Biolase, it is purely the fault of management for letting the situation get to this point. More prudent management in years past could have prevented this situation from arising.

Aemetis: Company Overview

Aemetis Inc is a $200 million market cap producer of “alternative fuels”. The company produces biodiesel from a plant in India and produces mainly ethanol from a plant in California.

During Q1 of 2013, its ethanol plants were idled as the company was experiencing recurring negative gross margins. It was literally selling its product below cost, so it decided to shut down. In recent quarters, the company has resumed operations and a buoyant market for ethanol has seen the company begin to eek out tiny profits in two consecutive quarters. But it is still the case that over the past few years the company has accumulatedover $80 million in cumulative losses.

Aemetis Inc uplisted from the OTC BB to the NASDAQ in May and its share price quickly shot up from an initial price of $5.00 to over $12.00. One contributing factor was the strong performance of any stock with an ethanol connection. For example, Pacific Ethanol (NASDAQ:PEIX) is up by 400% in the past year. Aemetis has simply ridden on the coattails of the sector.

The share price was also no doubt buoyed by a Seeking Alpha article entitled: Aemetis Is A Potential Four- Or Five-Bagger as well as by the initiation of “research” on the company by See Thru Equity which came with a $26 share price target.

See Thru claims (in all caps) that it does not get compensated to write such reports. But instead, See Thru charges its clients $11,000 for slots at its conferences. It then issues hyper bullish research on the attendees “for free”. As noted on the See Thru website, Aemetis is an attendee in See Thru’s conferences.

In reality, this is all just a very transparent way to pay for positive research on one’s own company.

Both the article and the research report contain materials which are largely a simple repetition of company presentations, including links and direct quotes. As a result, they not surprisingly portray the company in a very optimistic light and contain multi-bagger share price targets.

Yet both of them ignore the obvious realities which are contained in the Aemetis’ SEC filings. Even a quick and cursory read of the company filings reveals the following:

- Aemetis already is and has been in default on its debts, with creditors already attempting to seize assets.

- The company has just $4.7 million in cash and over $95 million in short term debt coming due.

- Over $65 million of this debt has been classified as “long term” simply because it is due 1 day after the end of the quarter. As a result, that $65 million is all in fact short term debt by now.

- Aemetis’ major lender is already “sweeping” cash from the company every day, not even trusting the company with cash overnight

- The company’s internal controls for accounting have been deemed to be ineffective.

- Creditors have already claimed as collateral ALL of the assets of Aemetis

- In order to avoid an immediate default, the CEO was forced to personallyguarantee $15 million of the debts with 100% of his own personal assets. If Aemetis defaults on even this portion, he loses everything he owns – personally !

As a result of the above, Aemetis (and the CEO) are in the situation where they simply MUST issue stock at any price and in very large size. They must also do so as soon as possible.

The intention to issue equity should be clear. The company just filed an S3 registration statement for up to $100 million. It is huge for a company of this size. The company also disclosed that it has already “engaged an investment bank” to advise on its financing.

An equity offering is desperately needed, there are no alternatives and the timing is imminent. These are the precursors for a death spiral to occur. This is why the stock has been selling off even after earnings which were relatively good (compared to the past). Yet many of the retail holders will have no idea what is coming.

The only reason why the equity offering hasn’t already occurred is that the S3 is not yet effective. This is also identical to what happened with Biolase. But just as with Biolase, the S3 can become effective immediately and with no notice, such that an equity offering could occur at any time.

How has the market missed this ?

The reason why this obvious situation has been missed by the market is that aside from existing insiders, the stock is almost exclusively held by retail investors. There is no institutional presence in terms of either investors or research. Because the stock was just recently uplisted to the NASDAQ, it is largely unknown to the wider market.

Furthermore, there are many retail investors who simply invest based on company descriptions who happen to be in hot sectors (ie. ethanol).

The share price of Aemetis has no doubt benefited from the other soaring ethanol stocks such as Pacific Ethanol which has been a stunning 5 bagger in the past year. Aemetis CEO Eric McAfee was an original founder of Pacific Ethanol, so some people choose to associate the two together even though Pacific happens to be a far healthier company.

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How did Aemetis get into this situation ?

In 2012, Aemetis sought to acquire a company called Cilion, but it didn’t have the money. As a solution, Aemetis went to a predatory distressed lender by the name of Third Eye Capital. This was really the beginning of the end for Aemetis.

In July 2012, Third Eye lent around $40 million to Aemetis by means of loans, notes and a revolving credit facility. The “stated” interest rates have been as high as 17% but due to a creative variety of fees, the real rate of interest has approached 100% per year.

Aemetis clearly had no ability to repay these debts. In fact, it could not ever even service the interest alone. Within less than 6 months, the company was already in default.

As a result, in October of 2012, Aemetis and Third Eye entered into Waiver and Amendment #1. This extended the maturity of the obligations to July 2014 and increased the lending amounts by $6 million.

But…the $6 million could not actually be drawn upon by Aemetis, it was simply extended to account for the unpaid interest. For Aemetis, the only real result was that their debt increased to $46 million, instead of $40 million, with no new cash coming in the door.

Aemetis was just borrowing more money from Third Eye so that it could pay the money directly back to Third Eye. This is how Third Eye makes a fortune. In mafia movies, it’s called “the vig”.

But wait it gets better.

In order to compensate Third Eye for this extension and waiver, Aemetis was required to “pay” an additional “waiver fee” of $4 million. But again, Aemetis had no cash, so this was just tacked on to the debt. So now the obligation became $50 million, instead of $40 million. And again, there was not even any new cash coming in the door at Aemetis.

The balance of the debt therefore increased by 25% in just 4 months !

That equates to an annualized rate of over 95% !

That was October, 2012. Within just 4 more months (February 2013), the company was again in default. So Aemetis agreed to Waiver and Amendment #2.

This time, Aemetis was required to issue shares to pay an additional extension fee of $1.5 million. In addition, Third Eye required McAfee Capital to pledge millions of shares as collateral. McAfee Capital is the investment company owned by Aemetis’ CEO Eric McAfee and which holds some of his shares.

That was the second default waiver within 8 months.

The third default and waiver happened just 3 more months later, with more waiver fees and increased debt balances in respect of unpaid interest.

Then there was a forth default and waiver. And a fifth. And a sixth. And a seventh.

At each new waiver just a few months apart, Third Eye would impose additional fees and would jack up the interest rates. The net result was that by late 2013 (less than 18 months), Aemetis’ debt to Third Eye had ballooned to over $72 million from just $40 million.

The “vig” was quickly compounding at a truly unsustainable rate.

By the end of 2013 (within 18 months) total annual debt service amounts were accruing and almost $30 million per year – and this for a debt that started at just $40 million in its entirety.

But Third Eye still wasn’t satisfied and was repeatedly demanding warrants. Aemetis was already in default. If Aemetis attempted to say no, Third Eye could just foreclose on the assets of the entire company. Third Eye could now call all of the shots.

As a result of the heavy warrants and shares being issued, Third Eye quickly owned over 17% of the entire company !

But at the current valuation, Third Eye’s equity stake is worth just $34 million – only half of what it has lent to Aemetis. And the problem now is that Aemetis has demonstrated a very limited capacity to pay down these debts.

As a result, Third Eye is now agitating for the equity offering. In one default waiver amendment, Aemetis agreed to give Third Eye 100% of the proceeds of any equity offering it conducts in excess of $7 million. This is how Third Eye plans to get its money back.

The stock will clearly be crushed and Aemetis will end up getting almost none of the proceeds, but Third Eye will get its incredible pound of flesh out of the deal after just 2 years.

What happened with earnings ? Why is the stock falling ?

Last Thursday, Aemetis reported Q2 earnings and the numbers appeared good on the surface. But the share price quickly fell by 10% that day and continued its descent on Friday. This is just what we saw with Biolase.

In the press release, the company noted the following:

- revenues increased 21% vs. Q2 2013

- Net income was $2.7 million compared to a loss of $9 .6 million in Q2 2013

- Aemetis paid down $13.6 million of debt (interest and principal)

These all would appear to be very positive developments. As such, retail investors were likely confused by the sharp drop in the stock.

More savvy investors quickly realized that positive comparisons to 2013 are unfair because the plant had been idled for almost a month during Q2 2013. Had it not been idled, revenues would have come out as being largely flat despite a very buoyant ethanol market in 2014.

In reality, the results are actually a bit of a disappointment.

As for the debt, a closer read of the subsequently released 10Q reveals that debt service expenses are still accruing at over $5 million per quarter (a run rate of over $20 million per year). In addition, every penny of cash generated by Aemetis has already been handed over to creditors, mostly to Third Eye.

But even after handing every penny of cash that came in the door, Aemetis still has over $95 million in short term liabilities coming due. Aemetis has made virtually no progress whatsoever even in the best ethanol market in a decade.

Note: Many investors could have easily missed the short term nature of $65 million these liabilities because in the form10Q they are classified as “long term liabilities”. The reason for this classification is that Aemetis agreed with Third Eye to set the new maturity date as July 1, one day after Q2 ends. As a result, they were technically considered to be “long term” obligations in the most recent 10Q – but only by a single day. These obligations are now clearly short term liabilities.

For those who care about accounting ratios, Aemetis has a stated “current ratio” of 0.4. That should already be extremely concerning. Anything below 1.0 indicates meaningful financial weakness. Anything below 0.5 indicates a severe liquidity issue.

But in fact it is much worse. Because all of these liabilities are now short term, the real current ratio for Aemetis is just 0.1. The company is visibly insolvent.

What about “alternative” financing sources ?

California Energy Commission Grant

In late July, Aemetis put out a press release stating that “Aemetis announces $3M CEC grant award”. Even though $3 million is not enough to move the needle vs. over $90 million in upcoming debts, the $3 million would serve as a small amount of welcome relief.

However it appears that investors may have assumed that this money was already distributed to Aemetis. This is wrong.

There are several problems here. First, the grant is still contingent upon approval of the project. It has not even been distributed. Second, the grant is a matching grant which means that Aemetis itself must put up $3 million in order to receive the grant. But Aemetis only has $4.7 million in cash total. Third (and most importantly), as part of one of the default waivers, Aemetis already agreed that any proceeds from grants would go straight to Third Eye. Aemetis will see none of the money from this grant.

California Ethanol Producer Incentive Program.

Aemetis is eligible to participate in this California program which subsidizes ethanol producers in times when crush spreads are too low to make money.

Unfortunately, the program also requires ethanol producers to re-pay the funds when times improve. Because times are good for ethanol right now, Aemetis actually owes money to this program.

As a result of this, Aemetis noted in the most recent 10Q that:

During the six months ended June 30, 2014, the strength of the crush spread resulted in the accrual and obligation to repay CEPIP funding in the amount of $1.8 million, the entire remaining amount of funds received from the program.

This is in addition to the other debts listed for Aemetis.

EB-5 Visa program

This is an odd one. In an attempt to obtain funding, Aemetis enrolled in a program by which it can effectively sell US immigration visas to foreigners. Foreigners can “invest” $500,000 each into notes issued by Aemetis. Because they are investing in a US business and presumably creating jobs, the foreigner then gets a US immigration visa.

The notes can be converted into Aemetis stock at a price of $3.00 – but only after 3 years.

Even though this appears to be a great deal (getting stock at $3.00) Aemetis has only managed to sell 3 of these visa investments since 2012, raising just $1.5 million. The reason that there has been no demand is that investors need to wait for 3 years in order to get their stock. These investors will know that they come behind over $90 million in debt, such that there is a very real chance that they may never get paid. In fact, in 2013, Aemetis was not even paying the owed interest to these investors who paid their $500,000 each. Not surprisingly, selling more of these has been difficult.

Despite only selling 3 of these in the past 2 ½ years, Aemetis continues to state that this is a source of funding which they hope to rely upon.

But once again (and of greatest importance), Third Eye has already laid claim to any potential proceeds from this source. In Default Waiver #5, Third Eye forced Aemetis to agree to remit any proceeds from EB-5 sales to Third Eye.

Loans from board members

In the recent past, CEO Eric McAfee has already forgone actual cash payment of his salary and benefits because Aemetis is unable to pay. Aemetis simply accrues these expenses along with the other debts which it is not paying. But because 100% of his personal assets have been claimed by Third Eye as collateral, Mr. McAfee is no longer able to extend any form of credit to Aemetis.

As early as 2009, board member Laird Cagan extended $5 million of credit to Aemetis which was secured by assets of the company. But as per usual, the company was unable to even pay the interest. As a result, the company issued stock to Mr. Cagan in exchange for the $5 million debt. As a result of this, Mr. Cagan ended up quickly owning 12% of the entire company which he acquired at just 45 cents per share.

This once again demonstrates what we are about to see: when the company has debts which it cannot pay, and when issuing stock is the only option, the price at which stock can be issued tends to be very, very low. Aemetis will truly issue stock at any price because it has no other options.

Complications for an equity offering – accounting issues

I was an investment banker on Wall Street for nearly a decade. I helped many troubled companies raise money when the situation looked very desperate. One thing I learned is that there is almost always a price at which a deal can get done.

I do believe that Aemetis will be able to complete some amount of financing to stave off insolvency. But it is also clear that the price at which a deal gets done for Aemetis will be very, very low.

We already know that nearly all proceeds of the offering will simply be handed to Third Eye. This is already a problem for potential investors because they know that a financing will not go to improve the business or increases capacity. The financing itself does nothing for Aemetis and everything for Third Eye.

But in fact there is a much larger problem looming for Aemetis.

Aemetis may have additional accounting problems which could require an even bigger discount from anyone who might choose to finance the company.

In its annual 10K filing filed in March, Aemetis noted that:

We have identified material weaknesses in our internal control over financial reporting which have materially adversely affected our ability to timely and accurately report our results of operations and financial condition. These material weaknesses have not been fully remediated as of the filing date of this report.

The deficiencies in internal control were not minor, in fact they were very significant.

The 10K (p. 28) explained that there may be significant problems with the numbers, most importantly including cash flow numbers.

The material weaknesses identified are: Ineffective controls exist to ensure that the accounting and reporting for complex accounting transactions are recorded in accordance with GAAP. A number of significant audit adjustments were made to the general ledger, which collectively could have a material effect on the financial statements. These adjustments were made up of entries to properly record the carrying value of debt issue costs, warrant accounting and various other adjustments summarized in our Report to the Audit Committee communication.

As part of our review of the financial statements included in the 10-K, we also made significant revisions to the statement of cash flows and various notes to the financial statements, which indicate that additional controls over disclosures need to be evaluated.

The company also noted that it was making efforts to remediate these problems.

But here is where it becomes much more problematic.

A few weeks later when Q1 was reported, Aemetis noted that

There were no changes in our internal controls over financial reporting during our most recently completed fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Despite the “no changes”, Aemetis management is now saying that the previously disclosed problems no longer matter.

On page 30 of the 1Q 10Q and on page 35 of the 2Q 10Q, it is noted that:

Our controls and procedures are designed to provide reasonable assurance that our control system’s objective will be met and our CEO and CFO have concluded that our disclosure controls and procedures are effective at the reasonable assurance level.

Something is quite wrong here.

When a company discloses serious deficiencies in its accounting controls in one quarter and then says that no changes have been made, it is not possible to suddenly say that the numbers, including cash flow, are all just fine. Yet this is what Aemetis has done.

The fact that these problems are being swept under the rug at just the time that the company is looking to complete a large equity offering makes the problem that much worse.

This is clearly something that small retail investors will miss, but larger investors who might finance the company will spot immediately. To the extent that they have any concerns over the accuracy of the accounting numbers, they will definitely require a steeper discount on the equity price.

Past 10b5 fraud charges against the CEO, Eric McAfee, will not help that matter either.

In a previous OTC BB oil and gas company, Verdisys, Mr. McAfee was also the largest shareholder and CEO.

According to the SEC, McAfee duped the company’s board into buying useless software from a different company which he controlled. He then diverted that money to a stock promoter to promote the stock.

McAfee then fabricated a large receivable from a supposed customer and forced the accounting department to put out the 10Q filing without letting the auditor review it. The auditor had already raised revenue recognition issues with the transaction. He did all of this in order to prevent the share price from falling.

This is all pretty bad stuff. As a result, Mr. McAfee was sanctioned for fraud violations and cease and desist orders were issued.

Here is what happened according to fraud proceedings with the SEC:

Verdisys issued two million shares of common stock, valued at $1 million, ostensibly to acquire software, but that the software had been deemed not useful, and Verdisys was therefore recording an impairment expense of $1 million.

McAfee had convinced the Verdisys board to purchase the software by claiming it would allow the remote monitoring of oil and gas wells, which would complement Verdisys’ sales of broadband satellite links to oil and gas companies. McAfee controlled the company selling the software, and he knew that the software only screened job applications and resumes of health care executives and did not monitor conditions in oil and gas wells. McAfee did not tell the company’s directors that the transaction compensated a stock promoter, who received half of the two million shares.

As a result, McAfee caused Verdisys, essentially a start-up company, to not disclose that it had issued one million shares and incurred a compensation expense of $500,000, to retain the promoter, before it could claim significant assets, revenues or business operations.

Verdisys delayed the filing of its quarterly report for the quarter ended September 30, 2003 (the “3Q Form 10-QSB”), after its auditor raised revenue recognition issues concerning a material $1.5 million receivable related to the company’s largest drilling contract. While the filing was in abeyance, McAfee caused Verdisys to issue an earnings release predicting the company would soon report record earnings.

McAfee participated in efforts to justify recognition of the $1.5 million receivable. On November 19, 2003, to meet the filing deadline and avoid any drop in the company’s stock price, McAfee ordered Verdisys’ accounting staff to file the 3Q Form 10-QSB, even though the auditor had yet to review the financial statements found in the filing. The 3Q Form 10-QSB filed as a result claimed Verdisys had earned total current period revenues of $2.09 million, including the questioned $1.5 million receivable. The 3Q Form 10-QSB did not disclose that McAfee’s attempts to confirm recognition of the $1.5 million receivable involved a buy-out agreement, by which Verdisys would assume substantial liabilities and forego collecting upon the $1.5 million receivable to purchase the drilling project from which the receivable arose.

As a result of the conduct described above, McAfee caused Verdisys to violate Section 10(b) of the Exchange Act and Rule 10b-5 thereunder, which prohibit fraudulent conduct in connection with the purchase or sale of securities.

Ultimately McAfee settled with the SEC, paid a fine and moved on to other projects. Verdisys later changed its name to Blast Energy and is no longer listed.

I don’t expect that any retail investors have conducted this level of research in evaluating their investment in Aemetis. But it should be expected that investors who might choose to participate in an offering of up to $100 million will focus quite clearly on this history.

The fact that Aemetis recently disclosed its internal accounting problems and then quickly covered them up just in time for a financing will certainly be noticed and will be another factor which will require a steep discount in selling new equity.

It will not be lost on the investors that absolutely all of Mr. McAfee’s personal assets have been pledged to secure the loans of Aemetis. If the Aemetis creditors choose to foreclose, they will take everything he has. As a result, there is a very high amount of pressure on Mr. McAfee to get an equity deal done and to perhaps conveniently overlook the accounting problems which might interfere with getting his personal assets back under his own control and out of the clutches of Third Eye.

Please note: I did attempt to contact Aemetis by phone for comment and clarification on these issues but my calls have not yet been returned.

Conclusion

Right now there are very strong tailwinds boosting alt energy stocks such as biodiesel and ethanol plays. This can be clearly seen by looking at the soaring share prices of stocks such as Pacific Ethanol.

But unfortunately the dire straits in which Aemetis has landed basically ensure that no amount of tailwind is going to benefit Aemetis shareholders. For any amount of cash that comes in, Third Eye Capital stands ready to confiscate it. Third Eye is already “sweeping” cash from Aemetis every night. That applies to cash from biodiesel and ethanol sales, from grants and subsidies and even from Aemetis’ unusual US visa selling program. Third Eye and the lenders take everything.

Aemetis has over $90 million in near term debts and just $4.7 million in cash with which to repay it. But as of the last 10Q, much of this was technically referred to as “long term” debt. There is no mistake that this is currently short term debt now.

Aemetis has already defaulted on loans and its creditors have already begun attempting to accelerate the seizure of assets. Each time a default is waived for a few months only adds massive new debt burdens to the company in the form of waiver fees, penalties and new interest. The “vig” is compounding at an unsustainable rate.

But now the burden is getting so high that Aemetis risks collapse and now Third Eye finally needs to convert these debts into cash.

Aemetis has filed a $100 million S3 in order to sell equity and has engaged an investment banker to advise on financing. As a result, the share price has already fallen quickly by 30% in 3 weeks.

But now that the financing becomes more visible, the share price decline is likely to accelerate. No one wants to be left holding the stock when all of the other buyers disappear ahead of the offering. This is just what we saw with Biolase last year when the stock plunged by 80% in a single week.

Concerns over accounting issues and internal controls will likely mean that the discount required in an equity offering is even deeper than might otherwise be the case. Investors will want to know why Aemetis is now ignoring the accounting problems just revealed in March, and why they are being ignored right ahead of a must-complete equity offering. The past history of similar fraud by the CEO will certainly not help this issue with investors.

Based on these issues, a quick drop of 50-80% in the share price is now entirely predictable.

Disclosure: The author is short AMTX. The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it. The author has no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: The author was previously an investment banker for a major global investment bank and was engaged in investment banking transactions with variety of alternative energy companies. The author has not been engaged in any investment banking transactions with US listed companies during the past 5 years. The author is not a registered financial advisor and does not purport to provide investment advice regarding decisions to buy, sell or hold any security. The author currently holds a short interest in AMTX and has provided fundamental and/or technical research to investors who hold a short position. The author may choose to transact in securities of one or more companies mentioned within this article within the next 72 hours. Before making any decision to buy, sell or hold any security mentioned in this article, investors should consult with their financial adviser. The author has relied upon publicly available information gathered from sources, which are believed to be reliable and has included links to various sources of information within this article. However, while the author believes these sources to be reliable, the author provides no guarantee either expressly or implied.

Behind the promotion of Northwest Bio (NWBO)

Summary

  • Northwest Bio has been the subject of a massive promotional campaign which has seen the stock price soar.
  • Many of the authors involved have close hidden ties to promotional firm MDM Worldwide and / or Redfish Creative.
  • In some cases, authors have used fictitious identities and fake credentials within healthcare or finance. In fact they are simply paid writers.
  • Redfish Creative reveals its use of bulk pricing for writing undisclosed promo articles and mass message board postings on Yahoo.
  • Much of the promotional information written on Northwest has been either misleading or downright wrong.

Note: As part of his investigation, the author has shared the contents of this article along with additional materials with the United States Securities and Exchange Commission.

Note: Additional links and information on these topics has been and will continue to be shared via the author’s website. Readers can sign up for email alerts at www.moxreports.com. All content provided is always free of charge.

Overview

Since 2013, shares of Northwest Biotherapeutics (NWBO) have more than doubled. At their peak, they were a triple from last year.

During this time, Northwest has raised nearly $80 million from equity issuance on the back of the strong share price.

The driving force behind the share price has been a string of promotional articles from a variety of authors which have issued very bullish predictions for the stock.

In most cases, the technique being used by these authors is to write on Northwest in conjunction with press releases being released by the company.

Northwest has minimal institutional interest from outside investors at just 29%. As a result, the stock is easily influenced by analysis that is sophisticated in appearance.

As I will show below, many of the authors who have written on Northwest are using fake identities and fake credentials. They pretend to be biologists, other scientists or fund managers. In fact, they are just paid writers.

Since mid 2012, Northwest has made use of an IR and “social media” stock promotion firm called MDM Worldwide. Shortly after Northwest began paying MDM, the bullish articles began to appear from these fake authors. At the exact same point in time, MDM built a website for Smith on Stocks and Larry Smith quickly initiated coverage on all of MDM’s small cap biotech clients (including Northwest) with bullish / buy views. Smith has since written heavily on Northwest and has been the most ardent and outspoken bull on the stock.

These authors on Northwest have a broad and visible connection MDM and / or to “content” firm Redfish Creative, which has done work for MDM. Redfish has already provided me with pricing sheets outlining how much it charges for different types of (undisclosed) paid articles. Redfish has also laid out its techniques for (undisclosed) paid writing on message boards.

Both MDM and Redfish have emphasized the technique of writing articles in conjunction with press releases being issued by their clients.

Mr. Smith has provided coverage to every single small cap biotech client that pays MDM. But both Smith and MDM have taken steps to conceal the relationship and have removed key disclosures.

Readers should note that after I contacted MDM for questions, they quickly notified Smith of my interest. Mr. Smith then found it appropriate to update some of his disclosures regarding his real bio which had been concealed from investors. This includes the fact that he was barred from the securities industry by FINRA among other issues.

As shown below, much of the content that has been written by the writers described has been either misleading or downright wrong.

Note: MDM has assured me that it has never paid anyone to write any article on any stock. Please keep that in mind as you evaluate the facts below. Mr. Smith did not respond to an email from me.

Background

During the course of 2014, I have been highly focused on exposing undisclosed stock promotions which have artificially boosted the prices of various (mainly biotech) companies. My previous articles can be found here and here.

Public companies hired IR firms, who then hired writers (aka “consultants”) to conduct massive undisclosed promotions on a wide variety of media portals including Forbes.com, TheStreet.com, Seeking Alpha, Motley Fool and others. The consultant authors pretend that their analysis is independent from the company, but in fact their analysis is basically sponsored by the company and is (of course) heavily biased towards bullish conclusions.

Where this becomes illegal is due to Section 17b of the securities code which states that promotions must be disclosed if there is anydirect or indirect compensation from the issuer, from a broker dealer or from an underwriter. It was very clear in some cases that the issuers were involved in the promotion.

Section 17b reads as follows:

It shall be unlawful for any person, by the use of any means or instruments of transportation or communication in interstate commerce or by the use of the mails, to publish, give publicity to, or circulate any notice, circular, advertisement, newspaper, article, letter, investment service, or communication which, though not purporting to offer a security for sale, describes such security for a consideration received or to be received,directly or indirectlyfrom an issuer, underwriter, or dealer, without fully disclosing the receipt, whether past or prospective, of such consideration and the amount thereof.” (15 U.S.C. § 77q(B).)

The most notable example was the Dream Team Group, which was responsible for hundreds of articles in various sites that were entirely fabricated but which boosted the stocks of their biotech clients by hundreds of percent.

In some cases the authors have been “consultants” who are presumably not actually paid to write articles, but instead are ostensibly providing some other vague services during the time that they write the articles. The reality is that they only get paid as long as they write positive articles.

Single individuals have often used multiple aliases pretending to be industry experts. In many cases, these authors pretend to have strong credentials in the fields of medicine or finance when in fact they are nothing more than hired freelance writers who get paid by the article. Their bio’s are entirely fabricated.

As I will demonstrate below, it has now become apparent that these writers also infiltrate message boards such as Yahoo Finance and Investors Hub to create the false appearance of broad support from retail investors and to refute critics. But once again, these postings are simply bought and paid for and provide misleading information to unsuspecting retail investors.

The stocks involved in these promotions have been mostly biotechs and have tended to be overwhelmingly held by retail investors who can be easily influenced by the appearance of sophisticated and professional analysis. As their share prices soared, these companies raised tens of millions (each) via equity offerings which would have otherwise not been possible.

In the wake of my recent exposés, hundreds of promotional articles have been removed from these various sites. Some of the companies involved have already begun receiving subpoenas from the SEC. Many of the share prices have fallen by at least 40-60% from their promotional peaks.

Unfortunately some small retail investors still don’t understand the implications of being caught up in a stock promotion. Many retail investors take the attitude that:

I don’t care if there is a promotion going on. I believe that the results with the company’s drug will drive the share price. I have done substantial due diligence.

Unfortunately this view is very common when a stock is held overwhelmingly by retail investors.

But at a minimum, most investors will quickly realize that their “due diligence” has been largely based on information that is either highly biased to the positive or even outright wrong. It is information which has come largely from false experts who have undisclosed relationships and fabricated bio’s.

SECTION I: The Redfish world of paid stock promotion

So let’s get right to the point. Here is the pricing sheet which shows how much I would need to pay to get a stock promoted on various sites such as Seeking Alpha, Motley Fool, Yahoo or Investors Hub (see logos at bottom of graphic). The articles are written by professional writers and are structured to make intelligent use of SEO (Search Engine Optimization) technology in order to get maximum impact.

They are not your average bull articles, instead they are scientifically engineered to get the best response from readers. The authors being paid do not disclose any payment in their articles or any connection to MDM or other IR firms.

The techniques being used are far more sophisticated than those used by the Dream Team Group.

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This pricing sheet was provided to me directly from Redfish Creative. I did not use my real name when dealing with Redfish, for obvious reasons.

Redfish Creative is a small two man shop run out of Pittsburgh.

The “pricing” from the table above makes it clear that a “basic article” includes mere “factual research only”. I can have one of those for a mere $250. But because it is only factual it therefore has “low readership value”. So let’s forget about sticking to the facts.

By contrast, the more expensive “intelligent content” article will “help the reader form an opinion” or will “reinforce company branding”. This is of key importance. The value of these articles is to persuade investors to buy the stock – not to merely convey facts. This will only cost me $500, which seems like a bargain (but keep in mind, that is very much in line with rates I was quoted by Dream Team authors earlier this year. It is the standard rate for various firms in the “phony article” business.)

But if I want an interview of management published, it will cost me $1,000. Some readers may remember that in my past articles on stock promotion I was highly suspicious of what I referred to as “gratuitous interviews” being posted as articles on certain stocks. Now you can clearly see why. The interviews are nothing more than paid infomercials being conducted by paid writers who ask convenient questions to management in exchange for $1,000. Such interviews are then published on main stream sites under the guise of being independent. They have proved highly effective.

So those are the pricing options.

As I will show below, a small group of Redfish related authors have now written dozens of articles on Northwest Bio, and have written more than 100 articles on other MDM clients.

I did make it a point to contact Mr. Eastman. And I made it a point to inquire about how he promotes stocks in exchange for money. Eastman has emphasized that their process typically involves the use of management when writing on companies and they try to make use of interviews wherever possible.

Note: In the week before this article, I did contact Northwest Bio with questions via email. I received no response.

Here is what Eastman had to say via email. The full text of the email can be found posted here at MoxReports.com.

Thanks for the inquiry. We do indeed work in this environment and have multiple years of experience in doing so. We generally start with a content strategy and subsequent content plan for the target company and work closely with principles involved establishing objectives-outcome, media outlets etc. At times weconduct interviews of key management personnel as part of the content plan as this proves beneficial for the richness of the content itself, along with upcoming catalysts, events, industry news etc. We have a team of writers who publish on multiple sites including Seekingalpha.com, Motley fool, etc. We also control several outlets as well that can be used for advantage.

As for pricing, Mr. Eastman goes on to note that:

Our content plans range from $1,000 monthly to $3,500 monthly depending upon selected items, features, etc. I think you will find them to be very effective. If we are covering multiple firms, we can adjust a pricing plan accordingly.

In a separate email to me (full email available here atmoxreports.com), Mr. Eastman goes on to clarify that Redfish “employs” 4-5 writers (“contractors”). He would not name MDM specifically as his client due to client confidentiality within his contract, but he did go on to give some unmistakable hints about who he was working for:

A good indication though is that if you look at the subject companies we written about (ticker symbol) we were likely retained to by someone with an interest in those firms. It is never the company itself, but rather an IR firm, individual investor, or group of investors.

We have also worked over a 3-4 year period of time with aInvestor Relations-Social Media form in NYC. They represent about 20 firms. We built their entire social media structure and content plans.

Even better, Mr. Eastman included links (shown in the email link above) to 5 sample articles (including on Northwest) for which Redfish had been paid. 4 of these articles were clearly on MDM clients. In addition, Redfish states it was involved in creating MDM’s “Chairman’s blog” website.

But in short, there should be zero doubt that Mr. Eastman is referring to MDM as his client. But this should become more clear when we look at the articles that various writers have written on MDM clients below.

(Note: MDM did confirm with me by phone that it has used Redfish in the past, but stated that it has never paid anyone to write any articles on any companies.)

SECTION II: Promotions – which companies and how much promotion ?

We will now start to see a variety of companies which have been promoted. The reason I am focused on Northwest is that it appears to be the most heavily and broadly promoted and because the stock has been such a strong performer as a result of the promotion.

The following table lists MDM clients and the authors who wrote about them most heavily. MDM used to list its clients on its webpage. But following my March articles on undisclosed stock promotions, MDM deleted the client page. It can still be found using an internet tool called the Wayback Machine for those who care to verify MDM’s client list.

The numbers in the table represent the number of articles written on each MDM client by each author.

We can see that Northwest Bio (an MDM client since 2012) ranks #1 with more than 3 dozen articles. Almost half of these have come from Larry Smith (Smith on Stocks). Smith will be discussed in greater detail below.

All of the authors below (including Smith) have ties to MDM. This will also be clarified below.

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The key point from the table above is that this small group of affiliated authors doesn’t just write on one or two MDM clients by chance. Instead, they each provide extensive coverage to a large number of MDM clients even when those companies are in totally different industries, are of totally different sizes and have no sensible overlap. In the bottom row, we can see the total number of articles that each author has written on MDM clients.

Together they have written 169 times on MDM clients ! (See bottom right of table)

This is true even for the nano cap penny stocks such as 9 cent Amarantus (AMBS) and even the 1 cent PLC Systems (OTCQB:PLCSF).

This is also true even when it requires writing on other tiny illiquid nano caps (all of which are MDM clients) such as Chanticleer (HOTR) and Mobivity Holdings (MFON). Chanticleer runs a string of Hooters restaurants and has very little in common with Mobivity, a mobile marketing company.

Both of these MDM clients are just $15-20 million in market cap and largely illiquid. They have attracted minimal attention from anyone other than Redfish writers. Yet the authors who write about these two totally unrelated stocks tend to a) write about both of them (not just one of them) and b) write heavily about biotech companies who have also paid MDM.

Please note: I didn’t find these patterns by accident. Mr. Eastman did inform me of a substantial and effective paid campaign that was run on MDM’s Chanticleer / Hooters.

After Mr. Eastman told me about Chanticleer, finding the rest of their articles became easy. In many cases, the authors named above are about the only authors who have expressed interest in these companies. At the time, truly independent authors had no virtually interest at all in many of these tiny, illiquid nano caps.

The patterns described here should be quite obvious from looking at the table above. If they are not immediately obvious then you should have another look at the table and it should become quite clear.

It should also be clear that these various “Hooters authors” have written most heavily on Northwest Bio with almost 2 dozen articles. The articles are mostly highly bullish and often served to buttress Northwest against the serious concerns of critics. (Those issues on Northwest will be addressed separately below).

SECTION III: The use of multiple fabricated bio’s and fake names

I have circled 5 fake identities at the top of the table above. In total, these fake authors alone wrote more than 60 articles on MDM clients, 66 articles on Northwest Bio alone.

Yet unsuspecting readers end up being duped into thinking that they are reading independent analysis coming from a real person with real credentials (such as a “fund manager” or a “biologist”) rather than a mere infomercial.

Anyone who is willing to do the work can find that these identities are fake. In fact, I believe that much of the writing behind them is being subcontracted out to Eastern Europe and the Philippines (where the level of English is high) using a placement firm called oDesk which is used by freelance writers and computer programmers.

For example, we can see that Louis Dematteis claims to be a “biologist” on Seeking Alpha and he has a closely cropped picture of his face. On linked in we can see the exact same (uncropped) picture for a man in Serbia named “Pavle Borovac” who contracts for oDesk. He is a mere contract web designer for hire, not a “biologist” who invests in biotech. Here is his profile as a web designer on oDesk. Nearly all of the Louis Dematteis articles can be directly tied to MDM clients, including Northwest.

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I strongly encourage readers to click the links above to see that the pictures are in fact identical, just cropped differently.

But let’s keep looking at more of the people who have been writing on Northwest Bio and other MDM clients.

I strongly encourage readers to click on the links to the named authors below to read their bio’s. It would actually be amusing if it weren’t so illegal.

Alberto Savrieno is a supposed “European” who works for a “family office”. Yet he has written on 12 articles on MDM clients. Again, oddly this includes the $15 million company Hooters, it also includes tiny Mobivity along with 3 articles on Northwest.

Likewise for Andreas Spiro from “Geneva” who wrote 19 articles for MDM clients. Again, this includes $15 million market cap Hooters and $20 million Mobivity. He wrote 3 articles on Northwest.

The list goes on an on, and includes “Richard Richter“, “Suresh Gupta” from India and “Louis DeMatteis” the biologist.

Note: Please make en effort to remember these names, as they will become more important in the text below.

The identities described above are all to some extent fabricated or enhanced and are being sponsored by one underlying party with a strong interest in MDM’s clients. In total they have written nearly 2 dozen articles on Northwest Bio alone as part of more than 60 articles on MDM clients.

I did not include the writer Austrolib in the list of fake authors. This author who states he “invests in the Austrian economic tradition” (another European reference) can be found to be living in Miami, where he “writes financial content for a living”. So he is simply using a psuedonym and is not truly fake. He has written 12 articles for MDM clients, 4 articles on Northwest.

In the past, these authors were not discreet about the team effort, as shown in the following screen shot showing related articles for Car Charging Group (CCGI). They all write on the same companies at the same time.

This can be also seen clearly on their Hooters (Chanticleer) campaign where almost every article comes from one of these named authors. Again, Chanticleer is an MDM client and Mr. Eastman informed me that he had conducted a paid campaign on Chanticleer for an IR firm in New York.

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When describing the need for such promotions, Mr. Eastman pointed out to me that:

Please remember the company itself cannot generate their own content as it is PR, and there are SEC and FDA rules to content with. That leaves paid individuals as I’ve mentioned above, and journalists and the like, to do a good job. It is long term.

SECTION IV: What about Larry Smith (Smith on Stocks) ?

Observant readers will also note the presence of Larry Smith of Smith on Stocks in the table above.

Smith is important because he has been the most ardent bull on Northwest (and because he has provided dedicated coverage to all of MDM’s other small cap biotech clients as well). His articles have repeatedly moved stock prices of Northwest and other MDM clients.

Yet Mr. Smith has been concealing many important issues from his readers and from investors.

This includes his close relationship and history with MDM, the real details behind his professional background as well as his investor relations activities.

Last week I called MDM and asked a few questions about MDM’s relationship with Smith and with Eastman. As already mentioned, MDM has clearly informed me that there is no paid promotion campaign with any MDM clients.

Shortly after that call to MDM, there began to appear posts on Yahoo message boards stating that Richard Pearson would be writing a negative article on Northwest Bio.

At the exact same time, Mr. Smith suddenly provided an extensive update to his existing disclosure on Seeking Alpha and on his web site. He clearly knew that the jig was up and he began revealing details of his past which had previously been concealed.

It is quite clear from this chain of events that MDM was on the phone with Smith as soon as I hung up the phone.

I would encourage readers to read the new disclosure by Smith and ask why this very damaging information is only coming after he was found out by me. After explaining his “ethical breaches” and the “scarlet Letter” on his name resulting from his regulatory expulsion from Wall Street, Smith has now made it explicitly clear in his disclosure that he does not receive any compensation from IR firms or from hedge funds. He only receives subscription revenues from his site.

In a few paragraphs, I will highlight some hidden disclosures by Smith which describe the business of his DLS Research.

But let’s start from the top and see why Mr. Smith had to put out this new disclosure after he learned about my investigation.

First, Smith was kicked out of the brokerage and research business in 2003 when he was barred from the industry by FINRA. Smith notes in his (newly updated) disclosure that the mediator had specifically sought to end Smith’s career on Wall Street due to the violations involved.

Prior to being expelled, Smith had spent his last 8 years in the business bouncing around between small no-name shops (ie. not as a big hitter at H&Q or Smith Barney as shown in his various profiles).

Prior to a few days ago, Smith had only disclosed to readers his early career history at two prestigious firms, H&Q and Smith Barney. He neglects to show how he ended his career by working for his last 8 years at various no name bucket shops such as Sutro and Rodman & Renshaw. None of this had been disclosed to readers or investors until the last few days when Smith was alerted by MDM that I was paying attention to it.

Below is the real history from FINRA broker check.

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Mr. Smith has actively touted his incredibly strong bio in various locations and as extra ammo within his articles. He has made it clear that his experience and expertise are the reasons that we should listen to him and not to the uninformed critics of Northwest.

The incredibly strong bio that he has portrayed in his profiles has helped him move the stock of Northwest and others.

The key point is that Mr. Smith has clearly cherry picked a certain portion of his career to portray to investors while ignoring the parts that indicate bucket shops. As we will see below, this type of deliberate cherry picking is exactly what he does when presenting information on Northwest Bio. It is a technique.

Smith then neglected to mention to readers that the reason he left the industry in 2003 was that he had actually been barred altogether from the industry by FINRA.

According to FINRA Broker Check:

Smith engaged in conduct inconsistent by effecting stock transaction shortly before issuance of research report which he had prepared concerning such stock; caused a violation of exchange rule 472.40(2)(III) by failing to disclose that he held securities in stocks recommended in research report he authored; engaged in conduct inconsistent by opening accounts at a member firm that concealed fact of his employment at another member firm; and violated exchange rule 407(b) by maintaining securities at another firm without consent of his employer.

The seriousness of these offenses for a Wall Street analyst cannot be overstated. Smith showed a deliberate willingness to deceive his employer, the brokerages and (most importantly) investors.

As a result, in 2003, Smith was barred from the industry for the time. This is what really resulted in Smith launching his “consulting firm” DLS research.

As we will see below, DLS Research (ie. Larry Smith) was created to focus on investor relations and stock promotion and not “research”. DLS does not have a website, nor does it even publish research reports.

As we will also see below, DLS (ie. Larry Smith) has also advised institutional investors on financing deals for biotech clients and then he takes additional compensation when warrants are exercised. Smith on Stocks continues to write positive articles about those companies.

Concealing a close relationship with MDM

Ultimately Smith launched SmithOnStocks.com which does write about stocks. MDM did confirm with me that they built the site for Smith. Smith posts ample content on his site and then condensed content on Seeking Alpha which then links to his site.

Since establishing a relationship with MDM, we can see that the majority of his articles fall into two categories: either a) companies where he has advised hedge funds and where he has received compensation tied to their warrants or b) companies who happen to be clients of MDM.

For a time we could see the connection between Larry Smith (Smith on Stocks) and MDM in several places online. But immediately after my March articles on illegal stock promotion, both Smith and MDM took deliberate steps to conceal their relationship.

Below is a page from MDM’s website prior to March. The Smith on Stocks logo is featured prominently, along with a list of other MDM clients.

This page was deleted from the MDM website in March, shortly after my previous articles exposing illegal stock promotions. It can be found by using an internet tool called the Wayback Machine.

I added the red squares to highlight the stocks which Smith has written about. Clearly, there are plenty of MDM clients in which Smith has no interest, right ? Look again.

Smith only writes about biotechs, and he doesn’t write about nano-cap penny stocks. A few of the MDM clients listed are not even public. So if we white out the non-public companies and the non-biotechs, and then gray out the nano cap penny stocks, we can see the following:

Voila !

What we can see is that Smith has written on precisely every single “small cap biotech” stock which is an MDM client – bar none. More importantly, he has done so quite often (more than 60 times on Seeking Alpha alone plus dozens more on his own site). Smith is clearly a genuine asset to MDM.

Next we should look at the timing.

Smith originally developed his own website, which was run by Blueline International up until mid 2012. This can again be found using the Wayback Machine. It is notable that up until that time he had never written about any MDM client, despite having written over 100 articles on a wide variety of biotech companies.

In early 2012, MDM built a new website for Smith and he quickly began initiating MDM clients with “buy” recommendations.

This includes Smith on Stocks favorites such as Neuralstem (CUR), Insite Vision (INSV), OncoSec (ONCS), Trius Therapeutics (TSRX) and Agenus (AGEN), and of course Northwest Bio , among others. It quickly included 100% of MDM’s “small cap biotech” clients.

Again, this of course excludes MDM clients which are not public, which are not biotechs or which trade for just pennies.

Now, do you remember Louis Dematteis (the fake “biologist”), Andreas Spiro, Richard Richter, Alberto Savrieno, Suresh Gupta and the other fake “Hooters authors” from above ? These were the authors that can be tied to Redfish and writing on MDM clients. Ryan’s View was also a key writer.

How did the timing of Smith’s initiations coincide with these other authors ? Look and see.

Shortly prior to Smith’s initiation of Northwest Bio, most of these authors did not even exist and had never written on anything. But as soon as Smith began initiating on MDM’s clients, the variety of fake authors suddenly appeared and began initiating on the same exact stocks…at the same exact time….with the exact same bullish views.

This can be best illustrated by looking at MDM client Northwest Bio. Smith initiated on July 26th, 2012 stating “I am starting my coverage of Northwest Biotherapeutics with a Buy.”

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Not convinced ? The same can be seen with MDM client Insite Vision and the other MDM clients covered by Smith. In each case, these authors did not exist shortly before Smith initiated coverage. As soon as Smith initiated on the name, the newly created fake authors from above initiated at the same time. Not surprisingly the views were all the same as well telling investors to by the stock.

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Still not convinced yet ? How about MDM client Nova Bay (NBY) ?

For those who need even more convincing, I strongly suggest going back and looking up the first articles being writing on each of the MDM clients listed in the table in Section II. You will see the same pattern repeated again and again for MDM clients where Smith is involved.

More deliberate steps to conceal the relationship

Starting just at the time of these group initiations in 2012, it was suddenly noted on Smith’s site that his site was “powered by MDM Worldwide”. This can also be verified with the Wayback machine.

But following my articles on paid stock promotions (published in March 2014), this reference was deleted from his web page. As with the deletions by MDM, this effectively concealed the relationship. The changes to Smith’s website occurred at almost the exact same time as the page deletions on MDM’s site shown above.

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What does “DLS Research” really do ?

Fortunately I managed to find an old version of his web page which included an unpublished description of what DLS Research really does. Again, this was a version with no external links to it buried inside Smith’s site. I believe Smith does not know it is still findable. I put a red box around the DLS text which is not being disclosed to readers. But as we can see from the language, this text was writtenafter the launch on Smith on Stocks.

SmithOnStocks is owned by DLS Research, LLC, a biotechnology consulting firm that was founded in 2003. DLS Research, LLCdoes consulting work of various forms primarily with biotechnology companies and biotechnology investors. In no event does DLS Research seek to obtain access to or use non-public material. This consulting work can include but is not limited to advice on competitive forces; addressable markets; how to make disclosures to investors; opinions on investment strategies of potential investors; current financing trends on Wall Street and how they may affect the company; how to attract potential interest in the company from Wall Street analysts and Internet bloggersgeneral investor relations advice; reproduction in audio, video and written form of previously presented management event presentations and press; helping the company’s various releases to gain broader viewing throughout the Internetidentifying investor websites that are interested in companies like theirs, etc. Consulting fees start at nominal rates and can increase based on the amount of work that is done. In most cases, the consulting will be done with companies that the author knows very well, believes have interesting potential and on which SOS may write. No consulting client companies have editorial rights of any kind in regard to any publications of SOS and each recognizes and acknowledges that SOS will endeavor to only write a balanced view representing both negative and positive investment aspects of any company.

I was also able to uncover a separate hidden page which describes further activities of DLS Research and how it interacts with institutional investors. This page can be found if you type in the exact right address, but there is no link to it from Smith’s main page. Unless you figure out where to look, this page also cannot be found. Mr. Smith may have simply forgotten about it.

It reads as follows:

DLS Research has performed due diligence for an institutional investor that was instrumental in its decision to invest in equities of certain companies. As part of that investment theinstitutional investor received warrants. DLS Research, LLC has no ownership in any of these warrants, but may receive cash compensation if the warrants obtained are exercised; this is a component of the consulting fee received for the due diligence. This type of agreement applies to the following companies: Acadia Pharmaceuticals, Access Pharmaceuticals,Athersys, BioSante Pharmaceuticals, Corcept Therapeutics, Cyclacel Pharmaceuticals, Discovery LaboratoriesMela Sciences, Oxigene, Soligenix and XOMA.

The odd thing here is that Smith gets paid only if the company ends up raising new money when the warrants are exercised. Again, this relationship has remained undisclosed on his website and on Seeking Alpha. It helps to explain his views on non-MDM clients such as Athersys (ATHX), Discovery Labs (DSCO) and Mela Sciences (MELA).

Smith most recently published strong findings on Discovery Labs on June 13th, 2014 stating: “I continue to recommend purchase of Discovery Laboratories.”

No free lunch from Smith on Stocks

SmithOnStocks.com is a “subscription” web site which Mr. Smith runs and where he puts up substantially more content than he does on Seeking Alpha. Mr. Smith charges $29.99 per month to subscribe to this site.

Despite the subscription charge, much of the detailed content is 100% free to readers.

Yet “free” is apparently a relative term.

By analyzing the articles on his site, we can see that the majority of content for MDM clients (such as Northwest) and for his warrant clients (such as Discovery Labs and Athersys) is disseminated forfree, maximizing the distribution.

The point of all of this is that Smith only initiated coverage on Northwest after he initiated a relationship with MDM. Since that time he has become a prolific writer on Northwest and suddenly on all of MDM’s other small cap biotech clients. The timing coincides perfectly with the creation of new (fake) authors who focus almost exclusively on MDM clients and who can be tied to Redfish.

Smith has taken deliberate steps to conceal his regulatory background, his IR activities and his relationship with MDM. Yet Smith has also been the loudest and most vocal defender of Northwest Bio against critics who see the company as being promotional and misleading investors. During this time he has been a very vocal and prolific writer on Northwest.

SECTION V: Beyond articles – looking to the message boards

Getting back to Eastman and Redfish again, we can see that these types of promotional efforts are highly professional. They are not limited to simple bull articles. Instead, content is highly engineered to be optimized for search engines. Mr. Eastman has made this very clear to me.

In addition, the effort extends to engaging in conversations on message boards to gain further traction and the appearance of widespread popular support.

For Northwest Bio, this is highly relevant because the stock has a very active message board with hundreds of posts per day. Sadly, many retail investors rely on the NWBO board as a source of information and can be swayed by the sheer volume of positive comments that come out.

Below is a copy of the brochure the Redfish sent me which deals with message boards.

Anyone who has relied upon their “friends” from the Yahoo or iHub message boards may now wish to strongly rethink their confidence in the bullish analysis being found on these sites.

A favorite tactic for the paid shills is to try to generate camaraderie amongst retail investors to resist “the shorts” or “the bashers”. In fact, many of these warnings are coming from people using false identities who are being paid for their efforts.

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Message boards are dumb. Hopefully most readers here are aware of that. But they also have a tremendous impact on retail investors. This is why stock promoters make heavy use of message boards.

Note: As mentioned before, early last week I did contact MDM with questions for this article. Shortly thereafter there began to appear messages on Yahoo Finance warning readers that I would be publishing an article on Northwest Bio and why readers should not listen to me.

SECTION VI: How sophisticated have targeted articles become ?

Mr. Eastman emphasized to me the importance of scientifically engineering the articles to achieve the desired effect. Simply writing a “dumb” article touting a stock has become entirely ineffective these days. More is needed.

Separately, several years ago MDM had released a case study on one of its clients where it noted:

MDM first monitored keywords, investor boards for sentiment, studied traffic patterns, and discovered other hidden points on the world wide web where discussions were taking place that were directly focused on ACT as a company, as well as the discovery of opportunities for discussion based specific technology and research interest segments. Success in this campaign was made possible through careful consideration traffic flow and direction to and from websites where analytics could usefully be tracked. This was accomplished throughcreation of new ‘discussion based’ content centered andbased on press releases, implementation of discussion based topics to accompany the new content, deep linking those ‘discussion based topics’ to company controlled articles(within specific groups and social media accounts) based on the saturation of interest, and then monitoring traffic to and from those entry points.

That case study has since been removed from MDM’s website. But the point is clear: engineered content is far more sophisticated than most readers understand and it requires coordination with company issued press releases.

SECTION VII: Northwest Bio – evaluating discrepancies vs. disclosure

Northwest has paid promotion firm MDM Worldwide to manage a “content strategy” and/or media strategy. MDM has special relationships with authors who then write positive articles on its clients. That much is quite obvious. It is what MDM does.

During this time Northwest has continually issued various statements to investors in the form of press releases and SEC filings. These press releases have served as necessary fuel for MDM, Eastman and Smith.

As for MDM, even the company’s own website has emphasized the importance of coordinating press releases and “news” with “discussion based content” and “company controlled articles”.

As for Mr. Eastman’s, we can evaluate his previous comment again:

Please remember the company itself cannot generate their own content as it is PR, and there are SEC and FDA rules to content with. That leaves paid individuals as I’ve mentioned above, and journalists and the like, to do a good job. It is long term.

As for Mr. Smith, there was the hidden disclosure from his DLS research that notes that his work includes:

helping the company’s various releases to gain broader viewing throughout the Internet

The point of this is that without a steady stream of press releases, it is almost impossible for promoters to generate fresh content. Northwest has issued steady streams of press releases which are then picked up and turned into “discussion based content” by the real and fake authors we have seen above.

In many cases, investors are substantially persuaded to buy the stock, but without the author every telling any outright lies. The author is seldom foolish enough to write that 2+2=5. Such a strategy would be downright foolish and would be immediately disproved by other authors.

Instead, the authors often include large caveats about content being just an opinion or being uncertain. But in the end, investors are told to rely upon the credentials and credibility of the author. As we can see with Smith, the portion of his bio which he chooses to reveal was indeed impressive and in the past has helped him generate support from thousands of followers.

The examples that follow are not in any way meant to be exhaustive. These are just a few of the relevant examples.

IMPORTANT POINT: The point of these examples is NOT whether or not the reader agrees with the author on the facts presented. The point is whether or not the author has made statements which contradict Northwest’s formal disclosure in any way.

Note: In the week prior to publication of this article, I did attempt via email to reach both Larry Smith as well as Adam Feuerstein. Neither party responded with comments.

Example #1 – The “giant needle” debate ?

Just prior to ASCO, Northwest made public some data that indicated “extensive necrosis and partial collapse” of a tumor following just 3 treatments with DCVax-Direct. This seemed to “prove” that DCVax was working. The share price soared (as expected) due to the perceived effectiveness of the drug.

Adam Feuerstein of TheStreet.com remarked (sarcastically)

I’m shocked that when you plunge a giant needle four times into a tumor mass, then take a scan of that tumor mass, you find damage. Who could have guessed?

Mr. Smith rebutted Feuerstein, saying:

It seems indisputable that we are seeing a biological effectthat we would expect with an immune therapy as immune cells are being attracted to the tumor and are attacking cancer cells.

The fact is that Mr. Feuerstein missed the point in his statement. It is not the needle itself which is causing necrosis and collapse. Instead it is the injection of a liquid - ANY LIQUID - which causes the destruction. Even an injection of simple saline solution into a tumor could cause substantial destruction.

This was later addressed by Dr. Aman Buzdar speaking on behalf of MD Anderson which is involved in running the trials for Northwest. Dr. Buzdar has earned himself the wrath of Northwest bulls due to his criticism of recent promotional statements by Northwest. Nevertheless, he was the official spokesperson for MD Anderson which is running clinical trials for Northwest, such that his views do deserve consideration.

According to Dr. Buzdar:

The weakness of this approach is that there have been many studies in which tumors are injected locally — the injections could consist of anything — and you see tumor regression because of necrosis caused by inflammation

Mr. Feuerstein was therefore wrong about the underlying cause of the tumor destruction. But also, the conclusion presented by Mr. Smith is entirely wrong in itself.

It is far from “indisputable” that this effect is biological at all. If the effect is ultimately determined to be a “physical” effect – ie. simply due to the injection of any liquid causing inflammation – then we are left with a drug that is not having any more effect than saline solution. Investors have therefore relied on incorrect information as having been “indisputable”.

This is a far stronger statement than Northwest itself has ever made publicly about the effectiveness of DCVax Direct. Instead the statement has been communicated in a statement coming from an MDM relationship author.

Example #2 – What about the early release of “interim data” ?

Following the interview with MD Anderson, Mr. Smith made the following statement:

This is an open label trial and it is not unusual for a Company to release interim data before the end of the trial. There is nothing illegal or unethical in doing so as long as the information is accurate. My best judgment is that Dr. Buzdar is speaking for himself and not M.D. Anderson.

Mr. Smith has also stated that:

The phase 1/2 trial is open label which means that results are known to investigators and the Company as they occur.

First off, MD Anderson did follow up with an official statement which noted that:

MD Anderson was not involved in [Northwest's] decision to disclose the [DCVax] study information prior to the completion of the research. Therefore, we felt it was important to state that fact. We also felt it was important to state our belief thatreleasing incomplete research data is not accepted practice in our field.

Dr. Buzdar was in fact speaking for MD Anderson and not for himself. But this is not the point.

The real misstatement that was made by Smith is that this was in any way an “interim analysis“.

This is absolutely NOT interim data being released. Instead it isPATIENT LEVEL DATA being released in an arbitrary manner by Northwest at a time when the results just so happened to be positive. This is highly unusual.

As to the involvement of the trial investigators themselves (as opposed to just Northwest), Buzdar noted that:

Investigators at MD Anderson and the two other hospitals conducting the DCVAX-Direct study have not reviewed or analyzed data at all because patients are still being enrolled and treated. The statements being made by Northwest Bio about DCVax-Direct are derived from patient case report forms, which the hospitals are obliged to send to the company because it sponsored the study

This is of key importance. The data released by Northwest was not interim data and was not even reviewed or analyzed by the investigators involved.

What Northwest did was to put out raw patient level data. Larry Smith then “analyzed” the situation and declared the situation great for the stock. The stock price then soared. This is the promotion technique we see being repeated by those with an interest in Northwest.

It is cherry picking and the selective portrayal of anything that could be viewed as positive. Based on this, it is no wonder that Smith’s readers would buy the stock.

Example #3 – Is PFS an acceptable end point ?

This is another example of a debate between Feuerstein and Smith which has gotten off point. Feuerstein has accused Northwest of “sneaking” in a new risk factor into its 10K, warning that PFS may not be an acceptable endpoint. Feuerstein was mistaken on this point because this risk factor had already been included in a prospectus for a previous equity offering.

When or where this information was disclosed is entirely irrelevant to the real discussion on PFS. The real point of relevance is that Northwest has disclosed this as a risk factor, but Smith has presented compelling reasons to ignore it. But the information he presents is blatantly cherry picked and ignores substantial evidence to the contrary.

The cherry picking of positive evidence in favor of Northwest is the pattern that should be of concern to those who have been relying on Smith’s promotional “analysis”. Readers are guaranteed to see any new developments in the most positive light possible, while ignoring any facts that would raise concerns about Northwest.

In its recent disclosure, Northwest has included the following risk factor:

The primary endpoint of our Phase III trial is progression free survival. Sometimes regulators have accepted this endpoint, and sometimes not. There can be no assurance that the regulatory authorities will find this to be an approvable endpoint for Glioblastoma multiforme cancer.

Yet Mr. Smith stated flat out in an article that “Progression free survival is a solid primary endpoint for DCVax-L phase 3.” He then went on to basically tell readers to ignore the risk factor altogether, stating:

As everyone knows, lawyers write risk factors that try to cover any possible event. I remember one that recently warned that the Company’s production facility which was in a west coast city was at risk of being destroyed by a tsunami.

The debate over the appropriateness of PFS continues. Everyone is entitled to their own view.

But the acceptability of PFS will ultimately prove to be of key importance for DCVax-L. If it turns out that the FDA will not accept DCVax-L based on PFS, then the whole trial largely becomes a moot point. The drug will simply fail due to improperly selected endpoints.

As always, Mr. Smith is able to find impressive evidence to support his view, which also happens (of course) to be very beneficial to Northwest.

Mr. Smith states:

In rapidly progressing cancers, there are credible opinion leaders who believe that progression free survival is a very good endpoint. In a recent article in Neuro-Oncology, the authors concluded:

“In glioblastoma, PFS and OS are strongly correlated, indicating that PFS may be an appropriate surrogate for OS. Compared with OS, PFS offers earlier assessment and higher statistical power at the time of analysis.” Here is the link to the article is as follows:

Another recent video also goes into a discussion about using progression free survival as an endpoint in metastatic melanoma, which like glioblastoma multiforme is a rapidly progressing cancer. This is an interesting discussion (link).

Again, Smith has stated information which is factually correct and which clearly supports Northwest. But once again, Smith has also deliberately cherry picked information which will put Northwest in a positive light.

If I wanted to paint a picture that PFS is an approvable end point, I could certainly do so also. What I would do is just what Smith has done. I would provide quotes from parties (similar to Northwest) with an interest in drug development. These are the ones who WANT to see PFS used because it makes it easier for their drugs to get approved.

This is akin to providing quotes from big oil companies about their views on the environmental impact of burning hydrocarbons. Everything is apparently just fine.

Alternatively, I could also present an equally compelling case that PFS is NOT an approvable endpoint because it delivers no real benefit to the patient. It is “measurable” but it is not meaningful. This is why the FDA has been reluctant to accept it.

I can find equally prestigious doctors and scientists to support a very strong view against the use of PFS.

For example in the Journal of Clinical Oncology it is noted that:

It is time for the oncology community and regulatory agencies to take a hard look at PFS and challenge its growing use [by pharmas] as a primary efficacy end point. There should be good evidence for its ability to predict improved QOL or OS improvements if it is to play a central role in defining new standards of care. If it does not have these properties, we must measure the true end points of importance to our patients, andnot something that has as its chief advantage ease of measurement or speed of trial completion.

This came from a doctor who happened to have no conflicts of interest with the drug industry.

The following abstract addresses some of the inherent biases in PFS.

For those who following the oncology space, it should be clear that relying on PFS for approval is in fact a major risk. Smith had cited the approval of Avastin for use in glioblastoma multiforme based on PFS.

But – of course – he neglects to note that the previous approval of Avastin for breast cancer was revoked due to lack of OS benefit. Again, this is cherry picking facts in order to portray Northwest in the best light possible.

Example #4 – Prospects for revenue from Germany ?

Here Mr. Smith was very cautious in his choice of words. But the end result was that he planted the $50,000-$100,000 number into the heads of readers and investors. It is a very big number and many investors have now incorporated that into their expectations.

My speculation is that the price of the drug will be in line with that of breakthrough cancer drugs or roughly $50,000 to $100,000 per year. I want to re-emphasize that the Company absolutely refuses to make any comment on my price estimate until reimbursement negotiations are concluded.

Clearly Smith has included (and re-included) massive caveats here that management refuses to comment. So what we have instead of a comment from Northwest is Smith planting the $50,000-$100,000 number into the heads of readers in a way that can be walked away from when it doesn’t happen. In the short term, it still managed to get investors into the stock.

Yet we know clearly that Northwest cannot actively market the drug into Germany. And even Northwest itself has repeatedly likened the German program to “compassionate use“. Reimbursement at the level of $50,000-$100,000 is borderline nonsense.

Northwest has indeed refused to comment. But the number still got out there, now didn’t it ? This is why it is crucial to have such articles come out from various authors.

Example #5 – What are the odds of approval ?

The other related writers are far less cautious in their wording than the Wall Street trained Smith.

For example, Austrolib states that:

DCVax-L still has a good chance of being approved. And all sides agree that DCVax-L’s side effect profile will most likely come in benign, as side effect profiles tend to do for other autologous vaccines.

Clearly no management team would ever make such bold statements themselves in an actual press release. But instead, an author with clear ties to Redfish clients made it for them.

Conclusion

Investors in Northwest Bio and a variety of other biotechs now have every right to be concerned about their supposed “due diligence”. Much of what they have been relying on is either misleading or wrong.

Dozens of fake articles have been written by fabricated authors in attempts to elevate the stock price. The message boards are being infiltrated by shills who run deliberate campaigns. Readers are completely unaware that such campaigns are conducted.

Even the prestigious Larry Smith of Smith on Stocks (the biggest Northwest bull) has been concealing volumes of relevant information from his readers, including his close relationship with MDM Worldwide, his troubled past and his historical IR activities. Only after knowing he was caught has Smith reluctantly begun disclosing limited amounts of this information.

Various parties involved, including Smith and MDM, have stated clearly that there has never been any payment made for articles.

Yet the emails I obtained from John Eastman suggest otherwise in many cases. Backing up the information from Eastman is the fact that hundreds of articles on MDM clients have all been written by the same group of authors and have delivered glowing portrayals of MDM clients.

These authors were all created in the same narrow time frame to cover the same stocks that Smith was covering and with the exact same bullish views. And they all happen to be MDM clients.

Some retail investors may still take the view that

I don’t care if the stock was promoted, I believe in the prospects for the drug

Again and again, such a view has proven to be naïve and expensive.

First — many smarter investors will quickly realize that they probably do not understand Northwest or DC-Vax nearly as well as they thought they did. Smarter investors will realize that much of their supposed knowledge and perceptions about Northwest have absolutely been shaped by a promotion that was designed to create favorable perceptions of the company. Most investors only really “know” what these authors have told them. Upon reflection, this should be obvious and it should be very concerning.

Second — if the company did in fact have such strong prospects (as touted by the bullish promoters) then there would be no need for anyone to engage in undisclosed stock promotions, which could truly put at risk the entire future of the company. The simple fact that anyone engaged in a stock promotion raises serious doubts about the underlying fundamentals.

Third — the fact that the promotion (now exposed) is going to stopmeans that the share price will likely fall on its own. This is what we have seen with past promotions. Once a promotion pushes the stock up, it is imperative for the promotion to continue. This no longer becomes an effort to make the stock rise any further, but instead is an effort just to keep the stock from falling on its own. This is why we see so many repeat articles from the same authors. Once these authors are exposed, the articles stop. Then the share price inevitably falls. Every single time. This is just how stock promotions work.

Northwest has clearly been paying MDM for “social media” and / or “content” services over the past two years. During this time, there was a noticeable and dramatic surge in promotional articles being written on Northwest.

These articles were overwhelmingly coming from authors with ties to MDM, including Redfish which indicates that it get paid to write articles. Many of these authors are using false names and fabricated credentials.

As shown in the table in Section II, nearly every public company which is an MDM client also happens to have had a large ongoing stock promotion involving the same small group of authors to write on all of the stocks. I encourage readers to re-read the table above which shows the overlap between the fabricated authors and the MDM clients on which they wrote.

The takeaway from the points above is that even investors who still hold on to bullish views on a company’s drug prospects (despite the knowledge of a promotion) should not be surprised to see the stock fall dramatically now that the promotion has been exposed.

The last few stock promotions I exposed (found here and here) were primarily biotech stocks with various oncology drugs. Following my articles, many small retail investors quickly defended the stock on the basis of the drug’s prospects which they felt they had thoroughly researched. These stocks are now mostly down by at least 40-60% following the exposure of the promotions.

Notes: The author did attempt to contact management at Northwest Bio in the week before publication but Northwest did not respond with answers to questions. The author did attempt to contact Larry Smith for comment in the week before publication, but Mr. Smith did not respond to an email. The author did attempt to contact Adam Feuerstein for comment in the week before publication, however Mr. Feuerstein was on vacation and was not available for comment.

Disclosure: The author is short NWBO. The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it. The author has no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: The author was previously an investment banker for a major global investment bank and was engaged in investment banking transactions with a wide range of healthcare companies including medical device, pharmaceutical, genomics and biotech companies. The author has not been engaged in any investment banking transactions with US listed companies during the past 5 years. The author is not a registered financial advisor and does not purport to provide investment advice regarding decisions to buy, sell or hold any security. The author currently holds a short interest in NWBO and has provided fundamental and/or technical research to investors who hold a short position. The author may choose to transact in securities of one or more companies mentioned within this article within the next 72 hours. Before making any decision to buy, sell or hold any security mentioned in this article, investors should consult with their financial adviser. The author has relied upon publicly available information gathered from sources, which are believed to be reliable and has included links to various sources of information within this article. However, while the author believes these sources to be reliable, the author provides no guarantee either expressly or implied.

The ugly truth behind Ohr Pharma (OHRP)

Background

Over the weekend, physician Michael Sacerdote penned an article discussing Ohr Pharacuatical (OHRP) which was quite thorough and scientifically rigorous. He posted three major conclusions:

First, despite the apparent clinical efficacy of squalamine, the drug would be a commercial failure because it does not reduce the need for overall injections into the eye.

Second, with any possible approval being at least 4 years away, the drug will be too far behind rival Opthotech’s competing drug, Fovista. This again will result in commercial failure.

Third, the value of squalamine is zero.

Dr. Sacerdote is a physician and his scientific analysis reflects that. However, I do believe that the doctor has missed the much larger point with Ohr and squalamine.

In fact, this drug never had a real shot at success in the first place. The information gleaned from recent phase 2 trials has been known for more than 10 years. Yet the drug was already determined to be commercially unviable and was effectively discarded by its previous owner for de minimis proceeds.

Most importantly, the recent surge in the stock has simply been the result of a stock promotion provided and paid for by Ohr management. It has nothing to do with the prospects for squalamine and everything to do with management’s desire to issue more stock in equity offerings going forward. Ohr currently has a market cap of $250 million and less than $20 million in cash, with no near term drug prospects.

Recent developments

Shares of Ohr Pharma have been extremely volatile lately. The stock is held overwhelmingly by retail investors who can be easily influenced by small amounts of publicity, even when the underlying data is clearly not well understood.

On June 23rd, shares of Ohr rose by 16% due to the following announcement:

Ohr Pharmaceutical Announces Positive Interim Top-Line Clinical Results From Phase II Study of Squalamine Eye Drops in Patients With Wet AMD

Clearly the headline was very positive. And the contents within the press release were also very positive.

But the devil was in the details.

In fact, buried deep within the press release was the fact that squalamine actually missed its primary endpoint. The goal of the entire study was to reduce the frequency of Lucentis injections and this did not happen. The drug failed its objective. Period.

But given the incredibly positive spin, it was not at all surprising that retail investors bid the stock up. It was also not surprising that self-appointed biotech vigilante Adam Feuerstein was quick to cry foul.

One day later, Feuerstein pointed out the fact that the drug had actually failed. He also called management to task for the incredibly deceptive press release. Within two days, shares of Ohr were down by as much as 40%, briefly hitting $6.86, down from $11.40 post press release.

Yet within two more days, shares of Ohr were again up by as much as 60% from those lows, briefly hitting $10.97 again. The main contributor to this surge was an “upgrade” by Vista Partners which placed a new $31 price target on the stock.

Lest anyone miss their upgrade, Vista even put out a press release to trumpet it and included the key reasons for why Ohr should be a $31 stock.

Vista Partners Updates Coverage on Ohr Pharmaceutical, Inc. (NASDAQ:OHRP); Raises Price Target to $31

The bullish upgrade and the soaring share price were then further amplified by media sources such as Benzinga and TheStreet.com.

But there is one major problem here. The report issued by Vista (including the $31 target) was fully bought and paid for by Ohr management.

This fact was not disclosed in the press release by Vista and was therefore missed by both Benzinga and TheStreet.com (as well as other market sources). It was also clearly unknown to the retail investor base and it appears that very few people appear to have read the actual report from Vista Partners.

For those who wish to read the actual Vista report, I have included a pdf copy at moxreorts.com.

But it gets worse.

Buried deep on page 10 of the report, and in much tinier font, is the disclosure from Vista that:

This report has been prepared by Vista Partners LLC (“Vista”) with the assistance

OHR Pharmaceutical, Inc. (“the Company”) based upon information provided by the Company. Vista has not independently verified such information, and in addition, Vista has been compensated by the Company for advisory services for a one year period. Vista and its officers may have an equity interest – both restricted and unrestricted in the securities mentioned herein.

The key points to understand are as follows:

  1. The information in the Vista report was provided solely by Ohr management itself
  2. Vista then does not even bother to verify any information
  3. Ohr pays Vista for “advisory services” which includes putting out reports like this one.

The report from Vista is nothing more than a late night infomercial provided by Ohr management, yet it caused the share price to soar by 60% in two days.

It is very clear from the share price reaction that the heavy retail base of investors in Ohr did not even bother to read this report. If any of them did, they certainly did not find the tiny disclosure buried on page 10. Certainly Benzinga and TheStreet.com missed this.

So Strike One for Ohr is the misleading press release on June 23rd which painted a failed clinical trial in a stunningly positive light.

Strike Two is the use of a paid stock pump to further elevate its shares using a $31 share price target and a firm which doesn’t even bother to verify the information provided solely by Ohr.

Looking at the history of Ohr will reveal Strike Three.

It is the fact that squalamine largely never stood a chance at getting approved or of achieving commercial success in the first place. The drug was purchased for next to nothing after it had already failed to prove itself viable in clinical trials. It was largely just an excuse for Ohr to run a stock promotion with the goal of issuing stock to raise tens of millions of dollars.

The history of Ohr Pharma

Ohr Pharma was created in a simple reverse merger transaction in 2009, which was arranged by financier Orin Hirschman. Mr. Hirschman then appointed his father Shalom Hirschman to act as a consultant to oversee the purchases of various small and inexpensive pharma assets. By this time, the father had already sold to the corporate entity several “pre-clinical” drug assets in exchange for warrants on 5 million shares with a strike price of just 50 cents. Not a bad deal for mere “pre clinical assets”. The son already owned 18.9% of the public company by virtue of having arranged the reverse merger.

The company then appointed fellow financier Andrew Limpert to serve as its CEO. According to SEC filings, Limpert had (up until the previous year) been a control person for an investment advisor known as Belsen Getty. He also served various roles such as chairman and CFO of two publicly traded reverse mergers, Nine Mile Software and Profire Energy. For reference, SEC filings then describe the fraudulent activity, settlements and cease and desist orders involved from then CEO Limperts activity with manipulation and non-disclosure in these other reverse merger stock deals.

Later in 2009, with Limpert at the helm, Ohr completed the acquisition of Squalamine, Trodusquemine and related compounds from Genaera Liquidating Trust. The Company paid a mere $200,000 in cash for all of these compounds.

The cost per compound therefore comes out to something well under $100,000 each. We don’t know exactly how many compounds were purchased in this basket transaction so we can’t determine the exact average cost.

The first question becomes: why were the Hirschman’s and Limpert able to acquire these compounds so cheaply ?

The answer is that they arguably had no value whatsoever.

Squalamine was acquired from a Pennsylvania biotech company calledGenaera which had just wound down and liquidated its remaining assets for just a few pennies per share in June 2009. Among the “assets” being sold off were the rights to squalamine (for age related macular degeneration), trodusquemine (for obesity and now breast cancer) and various other compounds. (Genaera had previously attempted to develop squalamine under the trade name EVIZON).

Despite being shopped to dozens of potential bidders, the compounds failed to attract high bids and Ohr was able to walk away with the rights toall of these various compounds for just $200,000.

These assets were basically given away in bulk, and for a very good reason. In 2007 (two years BEFORE going out of business) Genaera disclosed that:

Additionally, preliminary information on subjects enrolled in Study 212 suggested that EVIZON™ was unlikely to produce vision improvement with the speed or frequency necessary to compete with recently introduced treatments. With this information, as well as evolving guidance from the FDA on clinical endpoints, we concluded there was no pragmatic option for the registration and commercialization of EVIZON™ for the treatment of wet AMD.

The drug was a failure and it was basically being given away as part of a bulk package of compounds for a nominal sum as part of winding up a bankrupt company.

But what is interesting here is to note that the original optimism by Genaera for the drug was based on vision and visual acuity, including “up to 8 lines” of visual acuity improvement. Sound familiar ?

The key point to understand is that these optimistic views on the efficacy of squalamine were expressed in a Genaera presentation to investors - in 2003 !!! They are nearly identical to what Ohr just disclosed in 2014 – 11 years later.

Ohr had absolutely no basis whatsoever for pretending to be surprised at any new and positive results. The company knew that in-line results should have been achieveable since the day they bought the drug.

Had these results actually mattered, they would have been used as the primary end point for the study. But they did not matter, so they were not used.

(click to enlarge)

(click to enlarge)

Now it is 2014, and a subsequent test of squalamine (not surprisingly) yields very similar results. Ohr had reported in its press release that “Percentage of Squalamine plus Lucentis PRN-treated patients gaining three, four and five lines in visual acuity was more than double the placebo plus Lucentis PRN arm”.

It sounds great. But does it matter ?

We can see that in 2014 the results that are being reported by Ohr are in fact slightly worse than the results we saw back in 2003. And even with those slightly better results reported by Genaera in 2003, the drug was ultimately abandoned as being irrelevant and commercially unviable. Aside from Ohr, no one was even willing to pay a meaningful sum for this discarded drug.

This was a drug with no real commercial value. Genaera was happy to basically give it away as part of a basket package deal.

What is the point of all of this ?

Once again, Ohr is being incredibly misleading by pretending that these results are new or are any sort of surprise. These results are simply a repeat of similar information which had been released 11 years earlier.

In fact, Ohr would have been fully aware of these findings in 2009 when it purchased the drug from Genaera. The latest press release is nothing more than a ruse to get the stock up. And the ruse was then repeated and trumpeted by Vista Partners (the firm that doesn’t verify any information provided by Ohr management).

The second question becomes: why would Ohr even bother taking an already failed drug through clinical trials ?

This is something we see all too often in the world of microcap reverse merger biotechs. A company buys a drug “asset”. The result is not to buy the best drug. Instead it is to buy the cheapest drug asset it can find and then simply maximize the hype surrounding it. The stock soars and the company raises tens of millions by selling stock. This capital raised can hopefully be used later on to buy or develop a real drug, one that actually might work. In the meantime, executives and directors pay themselves hundreds of thousands per year in salaries while they wait.

By 2010, Ohr had purchased a small variety of compounds from different sources. Total cash outlay was well under $1 million such that the cost for each compound continued to be negligible. The company then took on new management with more “marketable” credentials than Mr. Limpert.

Dr. Irach Taraporewala was appointed CEO with a base salary of just $61,000 plus some stock. It turns out that Dr. Taraporewala was an associate of Shalom Hirschman (the father), with both of them working together at an OTCBB penny stock company called Advanced Viral Research. That firm went bust in 2009, just as Orin Hirschman was assembling the Ohr reverse merger. The timing was therefore perfect.

The Hirschman’s then appointed Sam Backenroth as CFO. Mr. Backenroth was just 26 years old with two years of work experience and had no experience as a CFO. His starting salary was $24,000.

The point from all of this is that the goal is not to “succeed at any cost” like a true pharma company. Instead it is a strategy known as “fake it ’til you make it“.

Acquire assets and people with minimal value or relevant experience and then spin an impressive story around some massive future potential. When the stock soars, raise as much money as possible to create as much “disposable capital” as possible.

In this way, the financiers can turn an investment of a few hundred thousand dollars (used to purchase defunct compounds) into “disposable capital” of tens of millions.

When the stock needs a little help, management can always rely on stealthy paid reports (such as from Vista Partners) and misleading press releases to help boost it up a notch. In addition, by building relationships with a few small cap investment banks, these types of companies can occasionally get bullish sell side coverage. It is obvious to these banks that companies like this will be frequent investment banking clients due to the never ending need for capital.

This is the formula for reverse merger riches, and I feel that I am seeing it clearly once again in Ohr. The only problem is that ordinary share holders find themselves sitting on a serial dilution machine due to the never ending stream of equity offerings. Meanwhile those behind the promotion can simply award themselves more and more stock options to maintain their ownership.

Conclusion

Dr. Sacerdote came to the conclusion that “Value of Ohr’s squalamine eye drops for wet age-related macular degeneration is $0 or less”.

I entirely agree with Dr. Sacerdote’s conclusions, but for very different reasons. Dr. Sacerdote makes reference to such items as the “biological activity” and “molecular weight” of squalamine. I see this analysis as being accurate but largely unnecessary.

Squalamine was purchased for a negligible cost from a bankrupt pharma because it had already failed and was clearly worthless. Dozens of other buyers had the opportunity to bid on squalamine and no one was willing to pay a material price.

Ohr acquired the cheapest compounds that it could and then appointed the cheapest management that it could. There was never any real chance of these compounds succeeding.

Instead, Ohr has used misleading press releases and stealthy paid “research reports” to boost its stock price and raise money via stock sales.

Ohr Pharma is little more than a fools game for retail investors which has been engineered by clever financiers.

As or now, Ohr has around $20 million in cash and no material tangible assets. It’s drug compound portfolio should be evaluated in the context of the facts provided above. Against this, the market cap of Ohr is still over $200 million.

As investors come to terms with the stock promotion and the questionable assets, the stock will likely fall by at least 50%.

Even though much of Ohr’s current approx. $20 million in cash was raised in April, the recent efforts at pumping the stock tell us that we should be on strong lookout for more equity offerings coming up due to the fact the Ohr has zero near term revenue prospects.

Disclosure: The author is short OHRP. The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it. The author has no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: The author was previously an investment banker for a major global investment bank and was engaged in investment banking transactions with a wide range of healthcare companies including medical device, pharmaceutical, genomics and biotech companies. The author has not been engaged in any investment banking transactions with US listed companies during the past 5 years. The author is not a registered financial advisor and does not purport to provide investment advice regarding decisions to buy, sell or hold any security. The author currently holds a short interest in OHR and has provided fundamental and/or technical research to investors who hold a short position. The author may choose to transact in securities of one or more companies mentioned within this article within the next 72 hours. Before making any decision to buy, sell or hold any security mentioned in this article, investors should consult with their financial adviser. The author has relied upon publicly available information gathered from sources, which are believed to be reliable and has included links to various sources of information within this article. However, while the author believes these sources to be reliable, the author provides no guarantee either expressly or implied.

Synageva setting up for big disappointment

Summary

  • Investors and analysts have overestimated the market size for SBC-102 by at least 3-9x.
  • Most sufferers of CESD can be treated by proper diet and common statins (ie. Lipitor) without the need for a $300,000 drug.
  • Management has now sold 95% of its stock, reducing combined holdings to less than 1% of outstanding – even before their drug has completed trials.
  • Similar to Raptor and Aegerion, Synageva will likely drop by at least 50% from current levels.

[Note: just prior to publication of this post, an article appeared in the European Atherosclerosis journal entitled "Lysosomal acid lipase deficiency - an under-recognized cause of dyslipidaemia and liver dysfunction". The article contains references to many of the studies and issues which I have referred to below. That article was supported and funded by Synageva and Synageva researchers and is available for purchase via ScienceDirect.]

Company overview

Synageva BioPharma (GEVA) is a $2.6 billion biotech which specializes in developing drugs for very rare diseases. The company came public via a reverse merger in 2011 with failed biotech Trimeris. At the time of the reverse merger, legacy company Trimeris was held 36% by the Baker Brothers. Recent purchases by the Bakers have served to maintain (but not increase) this stake in the venture. Following 5 large equity offerings raising over $600 million from stock sales, the Bakers continue to currently hold just 35% of the renamed company, Synageva. The Bakers have made it their practice to buy into each of these equity offerings, typically in proportion to their ownership stake.

Synageva currently trades at around $75 per share and has a current cash balance of around $600 million (equivalent to around just $18 per share in cash). The company expects to lose $190-205 million in 2014. The company lost $95 million in 2013.

Short interest in the stock has gradually declined over the past few months, and now sits at just 4% of shares outstanding.

(click to enlarge)

In 2013, Synageva derived $13 million in total revenues from royalties on AIDS drug FUZEON along with additional collaboration revenues. But both of these revenue sources are declining and neither is material to the $2.6 billion valuation at present. Synageva has no other sources of revenue at present.

Synageva currently has several preclinical programs which it hopes to advance going forward. But for the time being, it has only 1 compound in clinical trials, sebelipase alfa (SBC-102). This is the compound which we will focus on.

During March, Synageva quickly dropped by around 30%. This was largely due to three factors. First, an unexpected (and unnecessary) $200 million equity offering put heavy pressure on the share price. Second was the news that the company expected it would lose around $200 million this year, which was far larger than expected. And third, it was largely the result of concerns regarding pricing developments at Gilead Sciences (GILD) which could affect the broader space of rare / orphan drug developers. Gilead has seen heavy backlash over the perception that prices for its new Hep C drug are simply far too high. The company is now taking steps to address these concerns including providing deeply discounted drugs to certain markets such as Egypt. But this discounting precedent caused Gilead and other drug developers such as Alexion (ALXN) to see similar plunges. These developments are not the primary focus of this article but are still highly relevant to the prospects for Synageva and others. I have included details in Appendix I.

Investment thesis

Synageva’s SBC-102 is highly likely to be approved by late 2014. FDA approval is likely not a concern or a problem.

Yet management has been rushing to sell nearly all of its holdings in Synageva. Management has now unloaded over $50 million in stock, representing more than 95% of its holdings. This has occurred even before its drug completes clinical trials.

CEO Sanj Patel alone has now sold nearly $37 million in stock…and holds less than $100,000 remaining. In April, Chief Medical Officer Anthony Quinn sold more than half of his remaining stock valued $1.7 million.

Meanwhile, the company was also quick to issue new shares in March, raising an extra $200 million that it did not even need. Synageva already had over $400 million in cash on its books.

Although the cash balance is still only $18 per share, this opportunistic offering resulted in Synageva raising far more cash than it needs, simply due to the desire to cash in on a high share price.

It is very easy to see why management has been so quick to sell.

The problems for Synageva are as follows:

  1. The market for SBC-102 is in reality much smaller than has been predicted (as shown below, analysts have over estimated the market size by 3-9x)
  2. Most of those who suffer from CESD have such mild symptoms that they do not require a $300,000 drug (depending on the severity, diet and simple statins like Lipitor will often suffice)
  3. For those with serious symptoms, other more permanent solutions are becoming available via bone marrow and stem cell transplants.

We have seen this exact same phenomenon with other rare / orphan drug developers. There is an initial surge when a company looks set to sell its drug at orphan prices of $100,000-500,000 per patient. The share price surges by hundreds of percent in anticipation of the company becoming “the next Alexion”. But when the market better understands the limited size of actual market, the stock quickly gives up its gains, plunging by at least 50%. Near identical examples are shown with Aegerion (AEGR) and Raptor (RPTP), each of which plunged by 50% or more after their sharp run ups failed.

LAL D / Wolman Disease / CESD

SBC-102 is currently in clinical trials for treatment of lysosomal acid lipase deficiency (“LAL D”). There are two variations of this genetic ailment, one is when it is early-onset (in infancy), while the other is late-onset (typically childhood to young adult).

When LAL D manifests itself in infancy (ie. “early-onset”), there is typically a complete absence of the LAL enzyme leading to harmful amounts of lipids accumulating in the spleen, liver, bone marrow, small intestine, adrenal glands and lymph nodes. Symptoms which follow include enlarged liver and spleen (hepatosplenomegaly), poor weight gain, low muscle tone, a yellow tint to the skin and the whites of the eyes (jaundice), vomiting, diarrhea, developmental delay, low amounts of iron in the blood (anemia), and poor absorption of nutrients from foodThis nearly always results in fatality, typically before age one. When describing early-onset LAL D in infants, it is known as Wolman Disease (“WD”). There is currently no approved treatment on the market for WD.

When LAL D manifests itself later in life, there are a wider variety of outcomes buy viagra online and severities to the deficiency. Unlike early-onset WD, the enzyme is present, but it is present in a malfunctioned form. In this latter case, it is known as Cholesteryl Ester Storage Disease (CESD). More information on the wider variety of outcomes due to CESD is provided below.

What is driving the $2.6 billion valuation of Synageva ?

Both manifestations of LAL D (ie. both early-onset WD and late-onset CESD) can be considered ultra-rare afflictions. But only with WD is it ultra severe (life threatening) in all cases. SBC-102 has been granted orphan drug designation in theUS and inEurope, and has been granted Fast Track Designation by the FDA.

Terms like “ultra rare”, “orphan drug” and “fast track” often result in premium valuations for the drug companies who can attain them. What these terms mean are that a drug is likely to come to market more easily, more quickly and at a tremendously higher price than for normal drugs.

For example, Alexion currently trades with a market cap of nearly $30 billion even though it markets only a single product sold to a few thousand patients. That product is Soliris, for treatment of several ultra rare immune disorders. The cost for Soliris: over $500,000 per patient.

In 2013, Alexion brought in over $1.5 billion in revenue, implying a total patient count of around 3,000 (perhaps slightly more, assuming some discounting in price takes place). Beyond just revenues, Alexion has also been highly profitable with this one drug. Even after R&D and selling expenses, Alexion was able to achieve operating margins will in excess of 25%. In 2013, net income was $252 million, putting Alexion on a PE of over 100x.

If Synageva held any such bullish prospects, then it would certainly be very difficult to reconcile this with the wholesale liquidation of stock which has gone on by the key members of management.

As shown in the table below, Synageva management members have been extremely quick to sell nearly all of their shares. They have done this almost as quickly as they get them via option grants.

(click to enlarge)

A list of all of the recent share sales by management has been included as Appendix II. As part of this, it can be seen the CEO Patel continued to sell nearly $10 million in stock this year. He now holds just $77,000 in stock. In April, the CMO sold more than half of his remaining stock. This follows sales of nearly all stock by other key members of management.

The purpose of the analysis that follows is to explain WHY management has expressed such urgency in selling nearly all of their shares of Synageva as quickly as possible.

Will SBC-102 be approved for WD and CESD ?

The answer is an almost certain “yes”. Even the bears on Synageva should agree that SBC-102 will be approved by the FDA without issue.

The real issue for investors is that there are three majorcommercial problems facing SBC-102, which explains management’s heavy share sales.

Problem #1: the total addressable patient population has been dramatically overestimated.

To evaluate this problem, we need to look at the two afflictions (WD and CESD) separately.

There is little debate about the fact that (early-onset) WD in infants is an ultra rare affliction. In fact, it would more aptly be described as ultra-ultra-ultra-ultra-rare.

According to the NIH, WD is expected to occur in just one out of every 350,000 live births. That means just 8-10 cases per year in theUS.

The numbers for WD are so small and are tied to new births such that that even if SBC-102 were to replace Soliris as the world’s most expensive drug, the total revenue it might realize would still not even justify the cost of the clinical trials and R&D.

So then WD is not where Synageva’s ambitions have been stated for commercial purposes. Instead, it is the hopes for treatment of (late-onset) CESD that have propelled the stock higher.

In attempting to size this market, the primary study being cited by Synageva management and analysts was one conducted in Germanywhich came to the conclusion that CESD should have a prevalence in the general population of about 1:40,000. That equates to 25 patients per million, or about 7,500 total affected individuals in theUS.

In its corporate presentation, Synageva has cited a wide ranging number from 1:40,000 to 1:300,000 and used multiple studies, blending together the ultra rare WD with the more common CESD. But it is clear from their estimates that many analysts have focused heavily on the 1:40,000 number. Morgan Stanley estimates the total patient population at exactly 7,500 people (exactly in line with 1:40,000). Wedush tones this down a bit and estimates it at just over 5,000.

What these sources fail to mention is that the German study was NOT a measurement of the incidence of CEDS in the German population at all. Instead it was a simple extrapolation of what might be expected in the overall population ofGermany based on a gene mutation model applied to just 2,023 individuals. This is very important.

The findings from this genetic modeling exercise were certainly not a clear cut measurement. This can be illustrated by the clumsy wording of the conclusion of the study. It comes to its 1:40,000 (25 per million) number by stating:

Assuming Hardy-Weinberg equilibrium, the homozygote carrier frequency can be estimated to 6 per million. Applying these results to the German general population, about 91 E8SJM homozygotes aged 18 years or younger would be expected. Under the assumption that this mutation represents about 50% of all CESD-causing mutations, the prevalence of CESD (homozygotes or compound heterozygotes) among German newborns is estimated at 25 per million, or a total of 366 cases under the age of 18.

After reading that paragraph, most readers likely walk away simply saying “huh ?!?”

The point to this very clumsy conclusion should be obvious. It does not even remotely resemble a statement that 25 people per million actually HAVE CESD. It is just an exercise in genetic modeling.

But for marketing purposes of SBC-102, all that mattered was obtaining a hard number which justified large revenues. In this case, that number was a hard and fast 25 per million.

Yet many seem to have ignored the very next (and most important) sentence in this German study, which states:

This estimate is in apparent conflict with the small number of CESD cases reported in the literature.

The “apparent conflict” and the “small number” of CESD cases should be very obvious. What it means is that IN REALITY, we don’t find anything even remotely near a 25 per million incidence of CESD.

According to the NIH website in 2007 (the same year as the German study)

Cholesteryl ester storage disease appears to be a rare disorder. About 50 individuals affected by this condition have been reported worldwide.

Since that time, and with the onset of clinical trials for a specific drug targeting CESD, there have been efforts by Synageva to increase awareness and reporting such that it should be expected that this will have increased from just 50 cases over the past 7 years.

Much of the reason for the low reported incidence of CESD is simply due to the fact that the disorder is “considered a benign indication” in most cases. It can in fact be treated by simple changes to diet and the uses of fairly simple statins such as Lipitor. As a result, it is often never even reported as a disease at all. This will be described further as part of Problem #2.

But it should also be noted that a more recent USstudy conducted in 2013 evaluated the incidence of CESD across various racial groups and estimated prevalence at 1:130,000. In other words, the “apparent conflict” disclosed in the German study and being used by the research analysts (ie. bankers) is that these numbers are overstated by 300%.

Some of the bankers do get credit for paying attention to the wide spread in the numbers presented by management. For example, Nomura points out the oddly large size of the variation between managements estimate of 1:40,000 and 1:300,000. Nomura then settled on a number in between at 1:150:000. That is about 7 per million, instead of 25 per million.

Not surprisingly, this resulted in Nomura placing a target on the stock that is $20 lower than Morgan Stanley. Morgan Stanley is clearly estimating a market size that is around triple that of Nomura.

Goldman Sachs took a similar approach, and an even smaller market size, and ended up with a $72 share price 12 month target upon initiation.

But moving into the next section, we can see that the real problems are about more than just debating the numbers. This is where all of these analysts are much further off, and why their share price targets will ultimately be cut in half from current levels.

Problem #2: unlike WD, many who suffer from CESD face very mild symptoms

With early-onset WD, the implications are categorical. There is a complete absence of the LAL enzyme. Symptoms are severe and if it is left untreated the individual will not survive. The entire purpose of having orphan drug status is to incentivize drug companies to develop treatments for underserved “orphan” areas such as WD.

But again, due to the ultra low incidence of WD, this is not where Synageva’s actual commercial hopes lie. Even at ultra high prices, there are simply not enough cases of WD each year to generate adequate revenue.

Synageva hopes to commercialize SBC-102 mostly for treatment of the (relatively) more common late-onset CESD.

The problem is that when it is late onset as it is with CESD, the symptoms are not black and white as they are with WD. In CESD, patients have a mutation to the enzyme (rather than a complete absence) and therefore still express some amount of enzyme. However, it has varying degrees of functionality.

According to the National Organization for Rare Disorders (NORD)

The symptoms and severity of cholesteryl ester storage disease (CESD) are highly variable from one individual to another. Some individuals may develop symptoms during childhood; others may have extremely mild cases that cause few symptoms. Still other individualsmay not have any noticeable symptoms (asymptomatic) and may go undiagnosed until well into adulthood.

Under the section entitled “treatment”, NORD goes on to note that

A hypolipidemic diet and statins are the main therapeutic toolsused against CESD. …The combination of diet and drug administration has led to dramatic reductions in the levels of lipids such as cholesterol and triglycerides in the blood of affected individuals.

It is from observations such as these from NORD that we can see that the severity of a LAL D diagnosis can vary quite widely from life threatening at one extreme to just heavy nuisance at the other. It is also safe to say that those in the nuisance category are not going to be spending over $300,000 on an ultra rare orphan drug. Instead, they will monitor their diet more carefully and take a statin such as Lipitor.

Obviously, with the most severe cases of CESD such mild treatment would not suffice.

Yet current sell side analyst estimates are calculated based on the assumption that the vast majority of all individuals who could be considered to have a CESD diagnosis will require the $300,000 drug.This is simply wrong.

This is not to say that CESD is without the potential for serious, life threatening consequences – in SOME cases. NORD goes on to note that:

In most cases, CESD is considered a benign condition, but insome cases significant complications may eventually develop including fatty liver (liver steatosis), fibrosis and finally micronodular cirrhosis with liver failure and esophageal varices due to altered hepatic venous circulation. The vessels swell and sometimes may rupture, causing potentially life-threatening bleeding. Abnormal enlargement of the adrenal glands (adrenomegaly) may also occur in few cases.

The point is that for some small portion of the CESD patient universe, there may be a genuine need for a $300,000 drug. But the size of this paying population is going to be incredibly small, nowhere near the thousands that analysts have been projecting when they have forecast hundreds of millions in revenue.

The point is that the even within the small population that is affected by CESD, most individuals have such minimal symptoms that they certainly will not be paying $300,000 or more for treatment. Many may not even know that it is called CESD. Some individuals that have it may even be entirely asymptomatic.

But there was also some excitement that Synageva has been able to complete enrollment in its Phase 3 clinical trial with over 50 patients. Presumably this would ensure that there is a large universe of patients around the world. Right ?

Wrong.

It is very important to note that the Phase 3 clinical trial “inclusion criteria” are simply that there exists in the patient a “Deficiency of LAL enzyme activity confirmed by dried blood spot ( DBS ) testing at screening”. What this means is that even patients who don’t have debilitating symptoms (ie. the “benign” ones) can be accepted into the trial as long as they simply evidence some sign of LAL deficiency.

As shown above, there are plenty of people who would test positive for CESD without even having symptoms or without even otherwise knowing that they had the indication. These people would certainly be accepted into the trial, but would certainly NOT end up paying $300,000 for the drug.

As a result, the enrollment of the trial is by no means an indication of who might end up actually paying $300,000 for the drug.

Problem #3, for those with a severe need, there are multiple other serious treatment options becoming available. These are permanent, one-time options as opposed to ongoing drug therapy.

As mentioned above, for those with only mild to moderate issues with CESD, there are ways to deal with it which are not burdensome at all. This includes proper diet and the use of drugs like Lipitor. There are also other alternatives such as cholesterol and triglyceride medications.

But even when we get to severe, life threatening cases of WD and CESD, there are still alternatives. These alternatives are very important to consider due to the high price at which SBC-102 will be sold.

CESD is often diagnosed in adolescence, such that a patient might end up being treated for as long as 70 years or longer. With an annual price tag of $300,000 or more, that implies a total cost to treat which could potentially exceed $20 million ! This is certainly an instance where the party paying for reimbursement would want to be well informed of all realistic alternatives.

As early as 2000, this study noted that “Wolman Disease Successfully Treated by Bone Marrow Transplant“. The focus of this procedure was on an infant with WD who would have otherwise died. At age 4, following the transplant, the patient was growing and healthy. This procedure is unlikely to be broadly applicable for WD (ie. for an infant) itself because of the risk of death due to the transplant itself. But it must be remembered that CESD is by definition a late onset of LAL D, such that it will be applicable to older children and adults who could more easily tolerate a bone marrow transplant.

The issue to keep in mind is that bone marrow transplants have successfully been able to permanently treat LAL D, which applies to CESD. The alternative for the patient to consider would be to keep taking a drug that costs $300,000 per year for the rest of his life. Again, this could even exceed $20 million total depending on the age of the patient when diagnosed.

A similar treatment success, but this time with stem cells, was also described in this report entitled “Successful treatment of Wolman disease by unrelated umbilical cord blood transplantation“. Again, the patient treated was an infant, so technically it was treatment for WD. But the results should apply to both WD and CESD (ie. both are simply LAL D with different ages of onset).

The implications are the same. For patients (or their insurers) the decision becomes whether or not to be treated once and for all via a transplant or to continue paying $300,000 per year for life and still be dealing with the unresolved health problem.

So now we know why management has sold virtually all of their stock ! The real world incidence of CESD is as much as 70% less than had been described, the severity of CESD typically does not even merit the $300,000 treatment…and in the few instances where it does, other more permanent options are becoming available.

With these facts in mind, the heavy selling by management becomes quite understandable.

Have we seen the same situation with other orphan drug stocks ? Yes.

Orphan drug stocks are now a red hot topic and have been seen as a source of windfall profits to the biotechs. As a result, we are seeing many of these biotechs overshoot due to hype and excess enthusiasm simply associated with their orphan status.

We can see repeatedly that orphan drug stocks overshoot on the way up when the market gets too excited about their potential to sell drugs for $100,000-$500,000 per year. Once the market better understands the real world potential, the share prices plunge by 50% or more.

For example, Aegerion Pharmaceuticals launched its orphan drug to much fan fare in December of 2012. Yet (just like Synageva) there were contradictory indications provided about the size of the addressable market. These varied by a factor of 10x (ranging from as few as 300 patients to as many as 3,000 potential patients).

In the interim (while there was still hype and uncertainly), the share price quadrupled during 2013, from $25 to over $100, as investors accepted the higher patient number as fact. As the actual performance failed to materialize, analysts were quick to cut their ratings on the stock (after the fact) and the stock is now down by nearly 60% from those highs.

For example, as recently as April 1st, Jefferies cut its price target to $80 from $90. The share price currently sits at around $45.

When the stock was still trading at over $80.00 in November, author Matt Berry had warned of this outcome using easily obtained and publicly available information. His point was simple: the real market size for this drug could in no way generate the kind of revenues to support this $3 billion stock. It was simply a function of market size. As was easily predicted, earnings were a disappointment, and the stock has since been cut in half.

As with Synageva, management at Aegerion were very heavy sellers of their own stock. In the past year, just as the stock was peaking, insiders unloaded over $85 million in their stock. The stock is now down by around 60% since its peak in October. Given the advance warnings and management selling, investors should have known better.

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Another nearly identical example is Raptor Pharmaceuticals . Raptor was a $7.00 stock when it obtained FDA approval for Procysbi, but the stock barely budged until it received orphan designation in the US and Europe. These designations, along with ample analyst upgrades, sent the stock to as high as $17.00. When the sales failed to meet expectations due to a smaller than forecast market size, the shares quickly plunged to their current level of around $7.00.

As with Aegerion, investors had ample warning in advance from Gravity Research which predicted the plunge based on overhyped forecasts of the tiny market size for Procysbi. Just like Matt Berry’s analysis on Aegerion, the analysis simply used easily obtainable public information to demonstrate a far smaller market for Procysbi than had been billed. The ultimate outcome was a decline in the stock of 55%. This should have been entirely predictable.

Also like Aegerion (and also like Synageva) management at Raptor has been heavy sellers since the stock peaked out. In the past few months, insiders have sold nearly $7 million and there have been no insider buys.

(click to enlarge)

As with these other orphan drug examples above, investors should have known better.

This dismal performance is all the more notable given the unanimous bullishness given across the board by the sell side analysts. Gravity had included the following table highlighting the research calls expressed on Raptor.

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In each of these cases, the information so easily obtained by these independent authors was somehow entirely overlooked by multiple investment banks who happened to be raising money for the companies. This analyst optimism is identical to what we see at Synageva, and we see it even by a number of the same investment banks.

With Raptor, the stock did briefly touch the high share price targets, but only before it fell by 50% to current levels where it now sits. Likewise, the share price targets on Synageva did serve to temporarily lift the stock to those levels before the current decline which we are now seeing.

As these miscalculations become apparent once again, we are also likely to see a decline of at least 50-70% in the share price of Synageva from current levels down to around $30-40. This level of decline would simply see the stock trading back where it was 1 year ago.

Management has no doubt been thrilled with the bullish support from Wall Street analysts, as it has allowed them to sell more than 95% of their shares, much of it in the past few months. These same investment bankers then reaped millions in fees from an equity sale by Synageva in March which raised over $200 million in proceeds.

But what about the big institutional buying by the Baker Brothers ?

Much of the confidence in Synageva stems from the continued buying by the Baker Brothers. In the March equity offering by Synageva, the Baker Brothers purchased 375,000 shares at a price of $105.80. So clearly they were looking to increases their holdings substantially, regardless of price, right ? Wrong.

The Baker Brothers strategy with Synageva has simply been to maintain their original ownership position and avoid dilution. Prior to the reverse merger with Trimeris in 2011, the Baker Brothers owned 36.2% of the company. And now 3 years later, following a continued stream of purchases at every equity offering, they now own 34.89%- ie. almost unchanged. All they have done is maintain their percentage stake in the company which they have owned for years.

This is almost identical to the strategy that we have seen with Dr. Philip Frost in his ongoing purchases of Opko Health (OPK). Dr. Frost continues to buy shares of Opko on a weekly (or even daily) basis, seemingly regardless of price. But what many investors fail to realize is that his ownership position has remained largely unchanged. Unlike, Synageva, Opko has largely refrained from issuing shares for cash and instead has been issuing shares as consideration for a string of acquisitions. In this way, Opko is increasing its number of “shots on goal”.

Were it not for his open market purchases, Dr. Frost would see his ownership stake in the company fall dramatically due to the for-stock acquisitions. But this is far different than the idea that he is conducting a “creeping takeover” (which view has been proposed incessantly by various small investors).

As with Dr. Frost and Opko, the Baker Brothers have an in-price which is at least 60-70% below current levels and a position size which is already large. The implications are two fold: First, incremental purchases vs. the large existing position do not really raise the in-price by very much. Second, with the in-price so low, it becomes nearly impossible to end up losing money on this position unless the stock falls by more than 70%.

With both the Bakers and Dr. Frost, their objectives and constraints are far different for the rest of us, such that they can feel free to continue to buy shares at much higher prices without an impact on their performance. The rest of us cannot say the same.

Author Stock Maustow ran two articles in December highlighting what appeared to be some very attractive trades put on by the Bakers. The premise was that by “following the smart money” we could also make money for ourselves.

Following Smart Money: Baker Brothers LLC Investments In 2013 And Beyond

Following Smart Money: Baker Brothers Investments In 2013 And Beyond, Part 2

The following table shows the results of the investments highlighted in these two articles:

(click to enlarge)

As we can see, simply following the smart money” and buying these Baker stocks would have led to average declines of 24% YTD and 43% declines vs. their recent highs.

The point is not to suggest that the Baker’s are bad investors. Nor is it to suggest that they have simply ridden up a multi year bubble in biotech stock prices. The only point to make is that the Baker Brothers have their own sets of opportunities and constraints which are not applicable to the vast majority of outside investors. Playing follow the leader is the wrong way to invest in biotech stocks. The right way to invest is to evaluate all facts and data and then decide where the most profitable investments will be relative to today’s prices.

Conclusion

As it applies to Synageva, the point should be clear. Common sense is showing us that there are likely to be just dozens or perhaps (at most) hundreds of applicable patients for SBC-102 at prices of $300,000 or more. This is far less than the thousands of patients which would be necessary to justify the current market cap of over $2 billion.

In addition, we can see that many of the potential patients may have symptoms which are so mild that they do not require the high priced drug. For those with severe symptoms, there are already alternative therapies (transplants) which may represent permanentcures rather than ongoing expensive treatments.

Meanwhile, management continues to sell its shares as fast as it can, mostly refusing to retain anything more than token holdings of the stock. So far management members have cashed out of more than $50 million in stock in the past three years. CEO Sanj Patel has personally sold nearly $37 million in stock and currently holds a mere 1,031 shares remaining – almost nothing.

Realistically, we should expect to see Synageva decline by around 50-70% from current levels.

Appendix I – Developments at Gilead and impact on drug pricing

In December the FDA approved Gilead Sciences’ Sovaldi, used to treat hepatitis C. The drug is fantastic. It is the closet thing we have to an outright cure.

It was granted Breakthrough Therapy Designation by the FDA and is effective on 90% of patients in as little as 12 weeks, only involving daily pills.

However, Gilead’s exorbitant pricing of the drug for $1,000 per day or $84,000 for 12 weeks of treatment has caused unbridled backlash from many stakeholders. “Never before has a drug been priced this high to treat a patient population this large, and the resulting costs will be unsustainable for our country,” said Express Scripts chief medical officer Steve Miller. Specialty drugs comprise less than 1% of all US prescriptions but account for ~28% of total spending on pharmaceuticals. Sovaldi is not the most expensive drug in the world, but costlier drugs typically treat extremely rare conditions whereas 130-150M people suffer from hepatitis C globally, 3.2M in the US.

Involved parties are not just idly complaining either. In its first guidelines on treatment of hepatitis C issued in early April, the World Health Organization suggested tiered price discounts by branded drug makers, voluntary licensing, and even compulsory licensing to combat unbearable prices. Express Scripts plans to create a coalition of employers, government health plans, and private insurers and is also working with doctors to delay treatment on many patients until lower-priced alternatives are on the market, probably in 2015. Representative Henry Waxman sent a public letter in late March: “Our concern is that a treatment will not cure patients if they cannot afford it.” Last month, US lawmakers asked Gilead to explain the $84,000 price tag.

With so many pricey drugs on the market, it is curious that this was the drug that finally sparked such an massive outcry about drug pricing. It is particularly notable given that this is for a drug which is extremely effective at treating a very serious problem.

On Friday March 21st (just after the close of stock markets), Gileadannounced that it would be offering the drug to Egypt at discounts of 99% vs. the $84,000 cost.

On Monday March 24th (in reaction to the Friday announcement), shares of Gilead dropped by as much as 6%. Other orphan drug makers such as Alexion and Synageva dropped by 7-10% as well. The message was clear that companies may no longer be free to simply set pricing at the highest level the market will bear. There can be qualitative consequences to even the perception that a company is charging too much for a drug – even when it is an effective drug for a much needed indication.

Appendix II – Stock sales by GEVA management

During 2014, 2014, Synageva insiders have sold nearly $13 million in stock, including over $9 million from CEO Sanj Patel alone. This brings total management sales to more than $50 million. Management has now sold over 95% of its shares. As a result of the recent selling, management now owns less than 1% of the total share count.

Date Insider Name Title Dollars Sold Shares Sold
4/1/2014 Anthony Quinn EVP, CMO & Head of R&D $ 1,670,691 20,000
3/12/2014 Chris Heberlig Group Vice President, Finance $ 755,992 7,670
2/18/2014 Carsten Boess SVP, Chief Financial Officer $ 1,012,369 9,927
1/28/2014 Sanj K Patel President & CEO, Director $ 9,014,999 102,300
12/3/2013 Mark Alan Goldberg SVP, Medical & Regulatory Affairs $ 423,649 7,000
11/18/2013 Carsten Boess SVP, Chief Financial Officer $ 546,857 9,927
11/1/2013 Mark Alan Goldberg SVP, Medical & Regulatory Affairs $ 349,753 7,000
10/1/2013 Mark Alan Goldberg SVP, Medical & Regulatory Affairs $ 450,203 7,000
8/20/2013 Carsten Boess SVP, Chief Financial Officer $ 682,188 14,481
8/16/2013 Carsten Boess SVP, Chief Financial Officer $ 204,121 4,300
7/25/2013 Sanj K Patel President & CEO, Director $ 4,801,679 100,000
7/15/2013 Chris Heberlig Group Vice President, Finance $ 122,249 2,524
7/11/2013 Carsten Boess SVP, Chief Financial Officer $ 622,933 13,237
6/11/2013 Sanj K Patel President & CEO, Director $ 2,845,756 70,000
4/5/2013 Sanj K Patel President & CEO, Director $ 1,570,276 31,605
4/3/2013 Sanj K Patel President & CEO, Director $ 1,954,542 38,395
4/1/2013 Mark Alan Goldberg SVP, Medical & Regulatory Affairs $ 239,831 4,416
3/1/2013 Mark Alan Goldberg SVP, Medical & Regulatory Affairs $ 224,217 4,417
2/20/2013 Sanj K Patel President & CEO, Director $ 3,443,621 70,000
2/1/2013 Mark Alan Goldberg SVP, Product Development $ 210,892 4,417
1/18/2013 Anthony Quinn SVP, Chief Medical Officer $ 473,106 9,447
1/16/2013 Anthony Quinn SVP, Chief Medical Officer $ 278,025 5,553
1/16/2013 Carsten Boess SVP, Chief Financial Officer $ 487,614 9,927
1/2/2013 Mark Alan Goldberg SVP, Product Development $ 209,896 4,417
12/19/2012 Chris Heberlig Vice President, Finance $ 183,705 4,000
12/13/2012 Sanj K Patel President & CEO, Director $ 2,772,438 60,000
12/4/2012 Sanj K Patel President & CEO, Director $ 1,712,105 35,000
11/30/2012 Sanj K Patel President & CEO, Director $ 1,726,818 35,000
10/17/2012 Chris Heberlig Vice President, Finance $ 198,620 4,000
10/16/2012 Carsten Boess SVP, Chief Financial Officer $ 497,650 9,927
9/4/2012 Chris Heberlig Vice President, Finance $ 49,100 1,000
8/31/2012 Sanj K Patel President & CEO, Director $ 3,462,891 70,000
7/26/2012 Anthony Quinn SVP, Chief Medical Officer $ 376,501 7,500
7/19/2012 Anthony Quinn SVP, Chief Medical Officer $ 125,000 2,500
7/18/2012 Carsten Boess SVP, Chief Financial Officer $ 323,091 6,618
6/25/2012 Anthony Quinn SVP, Chief Medical Officer $ 1,056,874 26,000
6/1/2012 Chris Heberlig Vice President, Finance $ 35,733 1,000
6/1/2012 Sanj K Patel President & CEO, Director $ 1,766,318 50,000
5/16/2012 Carsten Boess SVP, Chief Financial Officer $ 1,522,933 39,709
3/23/2012 Sanj K Patel President & CEO, Director $ 1,676,410 50,000
2/27/2012 Chris Heberlig Vice President, Finance $ 165,960 4,500

 

 

Disclosure: I am short GEVA. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

 

 

 

 

Additional disclosure: The author was previously an investment banker for a major global investment bank and was engaged in investment banking transactions with a wide range of healthcare companies including medical device, pharmaceutical, genomics and biotech companies. The author has not been engaged in any investment banking transactions with US listed companies during the past 5 years. The author is not a registered financial advisor and does not purport to provide investment advice regarding decisions to buy, sell or hold any security. The author currently holds a short interest in GEVA and has provided fundamental and/or technical research to investors who hold a short position. The author may choose to transact in securities of one or more companies mentioned within this article within the next 72 hours. Before making any decision to buy, sell or hold any security mentioned in this article, investors should consult with their financial adviser. The author has relied upon publicly available information gathered from sources, which are believed to be reliable and has included links to various sources of information within this article. However, while the author believes these sources to be reliable, the author provides no guarantee either expressly or implied.

 

Behind the Scenes with Proactive, Inovio and Unilife

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Note #1: Prior to publishing this article, the author filed detailed complaints with the US Securities and Exchange Commission regarding the parties and activities described herein.

Note #2: Due to the large volume of documentation obtained by the author, only a small portion is included in this article. However, the author has made efforts to ensure that the SEC and Seeking Alpha are aware of all findings, including those not detailed in this article.

Note #3: Many of the suspect articles referred to below have already been removed by Seeking Alpha. This can be seen by scrolling through Yahoo Finance, where the headlines still remain. However, the author had previously preserved electronic copies wherever possible in order facilitate ongoing investigation of the authors involved.

Investment overview

Following my recent article describing undisclosed stock promotions at CytRx Corp (CYTR) and Galena (GALE), using controversial IR firm The Dream Team Group.

Continue reading…

Behind the scenes with Dream Team, CytRx and Galena

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Note: At least 13 recent articles covering CytRx have been removed from circulation at Seeking Alpha, the Wall Street Cheat Sheet, Motley Fool and Forbes. Many were removed in just the past two days. A list of these removed articles is shown at the bottom of this article. The author has preserved PDF copies of these articles at MoxReports.com.

In total, more than 100 articles tied to The Dream Team have now been removed from circulation in just the past two days.

Overview

A few weeks ago I received a surprising email asking me to be a paid stock tout for IR firm “The Dream Team Group”. I was asked to write paid promotional articles on Galena Biopharma (GALE) and CytRx Corp (CYTR), without disclosing payment. Rather than refuse outright, I decided to investigate. I began submitting dummy articles to the Dream Team rep (with no intention of ever publishing them). My goal was to determine how involved management from these two companies were in this undisclosed paid promotion scheme. Below I will provide detailed documentation (emails and attachments) which indicate that management from both Galena and CytRx were intimately involved in reviewing and editing the paid articles on their own stock at precisely the time they were looking to sell / issue shares.

Continue reading…

Links to pulled articles on CYTR

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The following is a partial list of archived articles on CytRx which have been removed from circulation.  I expect to continue uploading additional articles on CytRx and other Dream Team clients going forward.

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sa_cytr_2013_11_19_JohnMlyant

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wscs_cytr_2014_02-04_JohnRivers

wscs_cytr_2014_02_03_JamesRatz

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wscs_cytr_2013_12_18_TomMeyer

wscs_cytr_2013_12_16_JamesRatz

wscs_cytr_2013_12_13_JamesRatz

wscs_cytr_2013_12_11_TomMeyer

wscs_cytr_2013_12_05_TomMeyer

wscs_cytr_2013_10_01_TomMeyer

Sungy Mobile Set To Burn US Investors

flame

Company overview

Sungy Mobile (GOMO) is a US listed Chinese ADR. The company’s main product is a downloadable “app” for Android phones which allows users to customize their icons and wallpaper. The company currently has a market cap of approximately $900 million and trades on a PE ratio of over 100x. The stock is very liquid and trades $10-15 million (over 400,000 shares) per day. Short interest in the stock is negligible at just 282,483 shares (less than 1% of outstanding).

Investment summary

Sungy represents a compelling short sale opportunity in the near term. At prices above $24, the stock has near term downside of at least 50%, which would still leave it trading above its recent IPO price of $11.22.

Just 2-3 weeks ago, the stock was still trading at around $20, so much of the gains are very recent.

In November of 2013, as China Internet related plays were soaring, Sungy launched an IPO of ADR’s which was downright abusive to investors. Inherent structural problems from the IPO, along with more recent indications of precipitous decline in interest for their products, will likely be the underlying reasons for a dramatic decline in the price. But the actual catalyst for this decline is expected to be the release of the first 20F filing in the next few weeks, along with the upcoming expiration of the IPO lockup.

The IPO’d shares are the only shares which are available to public investors. Sungy walked away with proceeds of $100 million from the IPOand its concurrent private placement. The proceeds are now presumably sitting comfortably in China.

But it is important to note that with the IPO, Sungy set itself up with an unusual dual class corporate share structure where public investors received heavily disadvantaged shares with almost no voting rights and which also happen to have no claim on the underlying assets of the company. Under this dual class corporate structure, US investors get 1 vote per share vs. 10 votes per share for the insiders who hold the special B shares. The result of this is that at the time of the IPO, outside investors put in $100 million in cash but will control less than 4% of the voting power – despite holding 27% of the outstanding shares. It was clearly a great structure and a great deal – for Sungy insiders, but not outside shareholders.

Meanwhile, the operating assets (within the VIEs) themselves remain in separate subsidiaries which happen to be controlled by Sungy management members, Mr. Yuqiang Deng, Mr. Xiangdong Zhang and Mr. Yingming Chang.

For those who wish to better understand the implications and pitfalls of Chinese VIE structures, I had previously written an article at Forbes discussing this topic a while back. For those who wish to read even further, there is a wealth of great information which is updated often atChinalawblog.com. It is safe to say that anyone who does not understand the basics of these structures has no business owning Sungy.

In fact with Sungy, the situation rapidly gets much worse. Buried in the prospectus, we can see that during the IPO process, Sungy was forced to disclose one material weakness along with two significant deficiencies in its internal controls designed to prevent fraud. These were as follows:

  1. Insufficient accounting personnel with US GAAP experience
  2. Insufficient IT control over financial reporting
  3. Failure to maintain ITGC management and security policy

An obvious question might be: So why not simply wait to go public until such serious deficiencies in control could be remedied ?

There are two reasons why Sungy did not wait and instead rushed to get the IPO out the door.

The first reason was that there was simply no need to fix the deficiencies. Even though Sungy is a company based in China, it took full advantage of the United States “JOBS Act”, a piece of legislation which was conceived in the US financial crisis to boost US employment. The Act was finally passed in 2012.

The title of the Act is an acronym for Jumpstart Our Business Startups, and it allows certain companies to apply for “emerging growth status“.

But it might as well be labeled Jumpstart China‘s Business Startups. A number of recent Chinese IPOs have already begun making use of exemptions (a.k.a “loopholes”) within this act which oddly allow even Chinese companies to reduce disclosure and come public despite significant flaws in their internal controls. Examples of recent Chinese companies who used JOBS Act exemptions include Qunar.com (QUNR), 500.com (WBAI) and 58.com (WUBA).

The JOBS Act was a deeply flawed piece of legislation, for these and many other reasons. It was almost a year ago that I wrote about this Act in the context of ServiceNow (NOW), noting that:

Such provisions under the JOBS Act have been controversial. A Bloomberg article entitled

Job-Creation Bill Seen Eviscerating U.S. Shareholder Protections” quoted the former chief accountant from the SEC as saying:

It won’t create jobs, but it will simplify fraud… This would be better known as the bucket-shop and penny-stock fraud reauthorization act of 2012.”

By applying for “emerging growth company” status, ServiceNow can opt to disclose fewer years of financial statements. It is exempt from certain disclosures regarding executive compensation. Investment banks love the provision that allows them to publish research prior to their IPOs – a practice which was banned following the dot.com boom and bust.

Perhaps of greatest concern is that these “emerging growth companies” do not need to have an auditor attest to their internal controls as required by post-Enron Sarbanes-Oxley.

Even though these exemptions should cause anger among US investors, the Act has been extremely popular among new IPO candidates. Although ServiceNow is not a Chinese company, its use of the JOBS Act is also quite inappropriate. When I wrote the previous article, ServiceNow had a market cap of roughly $5 billion – hardly suggesting it should qualify as a “startup”.

In any event, by using exemptions within the “JOBS Act”, Chinese company Sungy was able to come public even despite serious deficiencies in its internal controls. This makes it somewhat worse than other Chinese companies who have used the Act for different exemptions.

In fact, the exemptions utilized by Sungy allow the company to go for wellover a year after receiving its money from US investors without even remedying the deficiencies in internal controls. As a result, investors have very little assurance about where the money inside Sungy is going or how the company’s assets are being deployed in this company.

These deficiencies are all the more concerning for an unusual structure like Sungy where investors have no claim on the underlying assets and virtually no voting power.

The biggest risk investors will face is when additional disclosure must be released within Sungy’s first annual 20F filing as a public company, to be released within a few weeks.

Recent indications point to a precipitous decline

But the second reason that Sungy rushed its IPO was perhaps far more important. The offering was launched with perfect timing to coincide with a dramatic spike in revenues and online traffic for its Go Launcher Ex. The fact that the spike coincided with a strong surge in prices for other Chinese Internet stocks made this urgent timing for an immediate IPO even more imperative.

Investors in the IPO somewhat naturally assumed that this growth was natural and sustainable. But independent sources already provide strong indications that this growth was a spike, not a trend. The IPO prospectus included data up until September 2013. But even in the past 6 months, we can already see (shown below) a dramatic decline in 3rd party indicators which should accurately measure traffic and predict revenues.

In recent weeks, additional investors have piled in to Sungy simply because it is a “China Internet Play”. Unfortunately, these investors fail to realize that more than 70% of Sungy’s Go Launcher Ex users are based outside of China. Sungy is NOT a dominant China internet play. Sungy is NOT YY Inc. (YY). Sungy is not Qihoo 360 (QIHU). SUNGY is not Baidu (BIDU).

In fact, even Sungy’s mobile portal (3G.cn), which is predominantly in China, ranks it at just a top 7,000 or lower site in China. (see below).

Yet the mistaken notion of “China Internet Play” is largely responsible for the recent surge in the share price.

Investors should take note that even the investment bankers on the Sungy IPO (JP Morgan and Credit Suisse) maintain share price targets of just $17 and $24 (both issued in 2014). Yet the share price has recently surged to as high as $28 – as much as 50% above where its own optimistic bankers suggest it belongs. Even at the price of $17, JP Morgan rates Sungy a polite “Neutral”.

Sungy’s product offering

Sungy Mobile is a provider of mobile Internet applications, with an emphasis on its Go Launcher Ex and “mobile reading services”. Go Launcher Ex is a “launcher” for android based phones, which means that it is the first software that the android phone sees upon start up. It is the software that “manages apps, widgets and functions on Android smartphones”

The default launcher that comes with an Android phone is typically supplied by Google. After buying the phone, users can then opt to download alternative launchers such as that from Sungy.

Sungy derives its launcher revenues partially from paid downloads, but also largely from advertising spending (as would be expected).

The “mobile reading services” is comprised of an expanding library of original and copyrighted literary works. Readers are charged a fee to access these materials.

A third source of revenue is the mobile portal 3G.cn in China.

An initiation report from Credit Suisse showed the following revenue breakdown.

(click to enlarge)

In preparation for the IPO, Sungy commissioned (ie. paid for) a report by App Annie. The report yielded the following conclusions below. It is these conclusions which are largely responsible for the strong share price performance upon the IPO.

But investors need to remember that these conclusions were based on a snapshot in time as of September 2013. Because Sungy is a new ADR with limited reporting requirements, there has been no update by Sungy to these metrics since that time.

The conclusions from the IPO prospectus were as follows:

- Sungy was one of the top publishers world wide on Google Apps (in the “Applications” category).

- Go Launcher Ex was number one in the “Personalization” category

- As of October, Sungy had 3 out of 44 of the products with more than 50 million cumulative downloads on Google Play (but this is for “non game downloads” only, as games are much more popular)

- Go Launcher Ex has attracted approximately 239 million users, with over 70% of them being outside of China

- In Q3, average monthly “active” users reached 42 million

Indeed, these metrics make Sungy look fantastic. But in reality the Go Launcher Ex is just a fairly simple customization app for an android phone. The prospectus describes it as follows:

GO Launcher EX offers extensive functions and high performance that turn the use of smartphones into a more productive experience. In addition, through themes, widgets and various levels of customization, GO Launcher EX users can extensively personalize their smartphones and change the otherwise monotonous phones into exciting and sensible instruments that perform more in sync with their owners’ habits andsymbolize the individuality of their owners

Updates since the time of the IPO

According to the JP Morgan initiation report, Go Launcher Ex is the only one of the launcher products which has achieved over 1 million paid downloads. It scored a 4.5 on Google Play and had 1.3 million paid downloads as of the time of the JP report in January.

But a better leading indicator is to look at Google Trends.

(click to enlarge)

(click to enlarge)

The above screen shots can be replicated by going to Google Trends and entering the search terms “android launcher” and “Go Launcher Ex” as shown above.

These screen shots show two things. First, even though downloads peaked in 2013 (according to App Annie), actual searches for Go Launcher Ex peaked in 2012 and have been on a straight line decline since that time. Second, much of the real interest in downloads is coming from places like Myanmar and Bangladesh which are very difficult to monetize. We already know that over 70% of the business is coming from outside of China. But we can also see that the interest in Go Launcher Ex is largely coming from markets which are well away from the desirable US and European markets as well.

This is most likely the reason why Sungy did not bother to include a geographic breakdown of its users in the IPO prospectus.

It should be noted that GDP per capita in these countries sits at around $1,000-2,000 per year. They simply do not have the disposable income to either a) pay for downloads or b) attract advertising dollars.

As part of the IPO prospectus, it included a table showing market stats on mobile ad spending. (Note these are NOT stats for Sungy, they are stats for the market).

The table states the obvious: North America, Europe and Japan comprise the overwhelming majority of mobile ad spending. They are also responsible for the largest amount of nominal growth.

What does App Annie say now ?

The IPO prospectus relied heavily upon the commissioned one-time report from App Annie. But a closer look at subsequent developments reveals that App Annie data itself (as reflected in Google Play) is showing a peak and subsequent decline in downloads of Go Launcher Ex. Naturally we should not expect this type of negative data to have been included in a commissioned (ie. paid for) report as part of an IPO prospectus.

(click to enlarge)

The scale of the chart above (from 0-500) tends to understate the size of the declines in downloads. But by looking closer, one can see that Go Launcher Ex was largely a roughly top 50 product just a year ago (as was indicated in the IPO prospectus) but it has now fallen to being largely a top 100-200 app (with the exception of South Korea). The impact between a top 50 and a top 200 is typically exponential, not linear, such that the effect on subsequent revenues from paid downloads and ad spending will by necessity by dramatic. This will likely become clear in Sungy’s first 20F filing as a public company which will be released in a few weeks.

Trends with the mobile portal 3G.cn

The drop off in popularity for the Go Launcher Ex is largely mirrored by a similar drop off in recent months for the 3G.cn portal in China.

Detailed web statistics can be found for 3G.cn by searching at Alexa.com. As expected, the vast majority of traffic comes to this site from within China.

(click to enlarge)

But more importantly, we can see what has happened to traffic at 3G.cn since the IPO just 3 months ago. Fortunately, Alexa provides stats which happen to coincide with this 3 month period.

(click to enlarge)

As shown in the graphic above, at the time of its IPO Sungy’s 3G.cn happened to be a top 50,000 global website. But within just 3 months, this has slipped to top 75,000.

For those who (for some reason) seem to compare Sungy’s 3G.cn to Baidu, Sina or Qihoo, it can be easily seen that within China there are already more than 7,000 website which rank higher than Sungy’s 3G.cn in China.

Conclusion

Sungy’s IPO makes it a troubling investment in two different respects. First, the security which investors buy is strongly disadvantaged. It has almost no voting power due to the deliberate dual class share structure. It also has no claim on the underlying assets of the operating company due to the VIE structure. The company founders and insiders still run the operating assets, despite the conflict of interest that this creates vis a vis the public shareholders. In addition, Sungy made use of an inappropriate JOBS Act exemption to come public in the US despite having multiple serious internal control deficiencies.

The second issue is that these abuses give us a strong indication about management’s attitude towards how it will treat its outside shareholders. This includes how they timed the IPO.

The company rushed to come public at just the time when its business metrics were peaking. Investors must keep in mind that the primary product being offered by Sungy is simply an app which allows one to customize things like icons and wallpaper on one’s cell phone.

Independent metrics now show that most areas of Sungy’s business are now showing sharp declines in interest rather than continued surging growth. This is very typical for “one hit wonder” app and game developers.

What is less typical is when a company is able to rush out such a disadvantaged security to investors just as its metrics are peaking and at just the right time when all of the sector comps are hitting all time highs.

Given the aggressive structure that was sold to investors and the newly declining metrics, Sungy should be expected to trade back down to around its IPO price of $11.22 (eventually even lower). The reasons for this will become clear as soon as the company’s first 20F is released in the next few weeks. The aggressive nature of the IPO should also be expected to signal heavy potential selling upon the upcoming expiration of the IPO lockup.

Note: prior to publication, the author did speak with Sungy’s IR rep. The company currently says it is in a quiet period ahead of earnings and is not responding to requests for information. The earnings date has not yet been announced.

 

Author’s Disclosure: 

Based on the above, the author is short GOMO.

MiMedx set to fall further

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My last short article discussed Farmer Brothers Coffee (FARM) and since that time, the stock has come off by nearly 20% without much of a bounce. Prior to that, I discussed Unilife (UNIS), which is now down by 15-20% for largely the reasons I predicted. Before that, I highlighted unacknowledged and low-priced product competition for Organovo Holdings (ONVO). At the time, the stock had been trading around $13.00, and now it has fallen to $9.00. Prior to that, my earnings call on Ignite Restaurant Group (IRG) correctly predicted a fall of around 30% in that stock.

But for today, I am focused on an even better near-term short opportunity in MiMedx Group (MDXG).

MiMedx – Investment thesis

Shares of MiMedx are likely to see a decline of 30-40% in the near term. The stock represents an ideal short candidate due to its tremendous free float of nearly 100 million shares combined with a negligible short interest of just 5.8 million shares. There are also liquid options which trade on the stock.Institutional ownership is negligible and the CEO is the only insider with any meaningful ownership of stock.

Yet, these are not the real problems. The real reasons for the sell thesis are as follows:

1. A deeply flawed FDA clinical “study” which was irreparably skewed, providing stellar (but arguably misleading) results for the EpiFix product

2. Heavy marketing of that same study (by MiMedx and its banker/analysts) despite superior trials by competing products

3. A complete mis-presentation of the implications of recent Medicare reimbursement changes

4. Substantial changes in the competitive landscape for skin substitute products

5. Heavy selling by CEO Pete Petit (the largest shareholder) of over $1.2 million

6. Indications that the largest outside shareholder ADEC is liquidating (just sold below the stealth non-disclosure point of 4.99%)

7. The onset of analyst downgrades, with Northland seeing around 20% declines from current levels

This report is divided into three sections.

SECTION ONE - Background information provides detailed background information on the evolving situation at MiMedx, along with several reasons NOT to sell the stock. Presenting this information first will allow readers to better evaluate the real risks and the reasons why MiMedx is likely to be facing steep declines in the near future.

SECTION TWO – the red flags illustrates that there are more than ample warning signs which should presage the upcoming declines. The upcoming declines should come as no surprise to anyone.

SECTION THREE – the black swans details the much deeper negative catalyst events – which the mostly retail investor base has almost entirely ignored. Section three is clearly the most important part of this article. So for those who wish to “skip to the point” – section three contains the most price-relevant details.

SECTION ONE: Background information

With over 100 million shares outstanding, MiMedx currently has a market cap of nearly $800 million. Yet, with nearly 20 million additional (deep in the money) warrants and options outstanding, this market cap swells to over $1 billion. Many of these options have strike prices well below $1.00 and are set to expire in 2014, implying substantial near-term dilution.

MiMedx generated $40 million in sales over the first 9 months of 2013, resulting in a net loss of $2.7 million. The company has never generated a profit. The share price has recently been trading in the $7-8 range and the company currently has just 40 cents per share in cash (following a $39 million capital raise in December).

MiMedx Products

MiMedx Group describes itself as “an integrated developer, manufacturer and marketer of regenerative biomaterial products processed http://vinegarhillhouse.com/generic/ from human amniotic membrane.” What the company does is to collect donated human placentas from hospitals via C-Section births. These placentas would otherwise be discarded as medical waste. MiMedx then uses/processes these placentas into a type of healing application for burns and wounds.

The company’s two main products are EpiFix and AmnioFix. EpiFix can basically be viewed as an enhanced skin patch for use on external burns, wounds and ulcers. AmnioFix serves a similar function but is for internal use in sports medicine and surgeries, including spinals and tennis elbow.

On October 1st, the company announced that it had signed a distribution agreement with Medtronic to provide its allografts for distribution via Medtronic’s SpinalGraft Technologies (“SGT”) subsidiary. Terms were not disclosed.

These products are not FDA-approved via clinical trials, but instead have been governed under HCT/P regulations (“Human Cells, Tissues, and Cellular and Tissue-Based Products”) which allow marketing of products which have been minimally manipulated (among other criteria). These products are regulated under Section 361 of the PHS Act.

MiMedx Share Price Performance

Over the past two years, share price performance at MiMedx has been stellar. At their recent peak, the shares had risen from just over a $1.00 to just shy of $9.00. However, there is a very high likelihood of a 30-40% decline in MiMedx in the near future, to a price of around $4-5. Yet, the market has almost entirely missed the real reasons why.

(click to enlarge)

Two possible “red herrings” – NOT the reasons to sell

Again, for clarity, the following two issues are quite well-known and have been absorbed by the market. They are just presented for completeness.

During the end of 2013, a number of headline concerns caused the stock to exhibit substantial volatility. In September, panic over an FDA “untitled letter” following an inspection at the company’s Marietta, Georgia plant sent the stock plunging to as low as $1.81 in intra-day trading and the stock was halted several times during the day. The FDA letter stated the MiMedx had violated the Public Health Service Act by improperly manufacturing and marketing drugs that are also a biological product, but without a valid biologics license. The good news is that the products (currently) in question only comprise 15% of MiMedx’s revenues. The bad news is twofold: First, the company will now likely have to pursue an expensive FDA approval process and obtain a BLA. Second, even a minor hit to the financials may have a disproportionate impact on the share price due to the extremely high price-to-sales multiple and the historical lack of profitability.

So far, MiMedx has said that it does not agree with the FDA and is currently in discussions on how to proceed. For the time being, this issue has been digested by the market and does not appear to be a primary concern for investors.

A separate issue is the SEC investigation of potential insider trading violations by CEO Pete Petit in connection with information allegedly shared regarding his company Matria Healthcare prior to the sale of that company. The headline in the Atlanta Business Chronicle was short and scary, noting that “SEC Sues Pete Petit, Alleges Fraud“.

But the reality is that despite any previous violations, this investigation is unlikely to impact the specific financials at MiMedx. The downside scenario would be limited to the potential loss of Mr. Petit’s management involvement if he were forced to step down, and some possible pressure on the share price simply due to more negative headlines. As with the FDA impact above, this issue is not a primary reason to sell the stock, but the impact could be disproportionately large simply due to the very lofty multiple upon which MiMedx trades.

SECTION TWO: The red flags and warnings

One major problem at MiMedx is that as these (mostly retail) investors have gotten comfortable (desensitized) with the scary headlines, they have also overlooked a number of very real problems.

In November and December, MiMedx released a series of very bullish press releases which helped to bolster the stock. These items were then amplified by sell-side analysts (who happen to be the investment bankers for MiMedx).

(click to enlarge)

The share price continued to skyrocket on the back of their analysis and steep price upgrades. Within the space of a few weeks, Canaccord repeatedly boosted their target on the stock. In early November, when the stock was in the $5s, Canaccord told us it was a $6.50 stock. But as the much anticipated equity offering drew nearer, Canaccord nearly doubled the target to $12.00 in December. The basis for such a dramatic hike seems unclear. This increase implies an increase in market cap of nearly $600 million for MiMedx even though Canaccord only increased its 2014 revenue estimates for MiMedx by a mere $27 million. But as would be expected, the share price soared as shown above.

Not surprisingly, Canaccord was appointed bookrunner on MiMedx’s $39 million equity offering in December. Canaccord reaped millions in fees. Small cap investment bank Craig Hallum only had a $9 target on the stock, so they were only awarded joint lead status on the offering, making perhaps under $1 million in fees. But certainly, their $9.00 target did imply a 50% rise in the share price vs. its then prevailing level of around $6.00.

But wait. It gets better.

Shortly after the company sold $39 million in stock, CEO Pete Petit sold over$1.2 million in stock from his personal holdings. MiMedx’s largest shareholder (ADEC Private Equity) then reduced their holding to just below 4.99% of the company – allowing further sales (including a complete liquidation) to go without any need to report the sales. This is a very standard “stealth liquidation” technique.

And just as all of this was happening, we started to get the first analyst downgrades on the stock from Northland Securities with a $6.00 target. It should come as no surprise to anyone that the only bank to have the guts to downgrade the stock is the one who wasn’t being paid investment banking fees.

Despite the lofty targets from the research analysts (a.k.a. bankers), the company, the management and the largest holder were all suddenly eager to sell. But why?

From the Northland report:

Key Points

  • Our downgrade is a valuation callIrrespective of how Q4 numbers shape up or how aggressive fiscal 2014 guidance is provided, we cannot reconcile current valuation with the ground fundamentals.
  • In our opinion, we are entering a vicious cycle of CMS constantly squeezing out the marginal dollar from skin substitute reimbursement. For Mimedx, the current payment levels for Q-code reimbursement for EpiFix are “temporary” in nature. Once bundled rates come into effect, the playing field will be leveled. While EpiFix has favorable MAC coverage policies, that seems to be baked into the stock.
  •  However, our general impression of the tissue space has always been that most products are undifferentiated and suffer from a lack of rigorous randomized trials. Hence, aggressive marketing plays a stronger role than true clinical advantages or disadvantages….

At the bottom of this report, I will illustrate the transparent flaws in the research reports provided by the other (and far more bullish) sell side analysts who have provided investment banking services to MiMedx.

SECTION THREE: The black swans

Clearly, there are several issues which at one time spooked the investors in MiMedx, quickly sending the stock to as low as $1.81 in intraday trading. But even with the various warning signs that have been presented above, investors are continuing to award MiMedx a market cap of nearly $800 million to $1 billion.

The issues presented here in Section Three are the real issues which could well see the stock decline by 30-40%. It appears that very few investors are aware of these issues. Again, MiMedx is a stock which has minimal institutional holdings. The largest institution reduced its stake below 4.99% in January, such that we do not know if they still are even holding any shares.

A deeply flawed clinical “study”

The details behind MiMedx’s recently published “clinical study” are far more dangerous to the company’s near-term future than are the FDA letter or the insider trading investigation.

In 2013, the International Wound Journal published a study entitled “A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers“. This study had been initiated on the FDA’s ClinicalTrials.gov in 2012 and was sponsored by MiMedx.

The purpose of the sponsored study was to see how EpiFix (an amniotic membrane wound graft) compared to “standard of care” in treating Diabetic Foot Ulcers. These ulcers often affect the feet of obese diabetic patients. Healing can be impacted by factors such as age, weight (i.e. pressure on the wound) as well as the size of the wound.

The study concluded that

 

Patients treated with EpiFix achieved superior healing rates over standard treatment alone. These results show that using EpiFix in addition to standard care is efficacious for wound healing.

 

It also cited an overall healing rate of 92% at 6 weeks.

Not surprisingly, the truly spectacular results from this sponsored studyhave been widely repeated and quoted by sell-side analysts/bankers (to investors) and by management (presumably to doctors and prospective patients).

For example, Lake Street Capital quotes this study and management saying (almost verbatim)

 

EpiFix, the company’s lead product, heals diabetic foot ulcers (DFUs)twice as fast and three times better than competing alternatives at a lower cost,

 

Clearly, Lake Street didn’t bother to read the fine print contained within the study, or they may have expressed less of such unbridled optimism.

As part of the journal article, there was included a table which illustrated the demographic details of the clinical study for EpiFix. This table is reproduced in identical form as follows:

(click to enlarge)

Anyone who understands clinical trial design (or even just plain statistics) is likely now hitting the “sell” button on MiMedx before reading any further.

The implications of this table should be quite obvious.

On average, patients in the EpiFix trial group were 5 years younger. Their wounds were 25% smaller. Their body mass (i.e. obesity) was around 15% less.

In fact, as shown in the table above, the deviations from the mean are even more significant than the means. With EpiFix, the youngest patient was 15 years younger than in the SOC group. The lowest body mass was 20% lower. The SOC group had a maximum wound size that was 20% larger than for the EpiFix group.

With such a skewed patient population, it would have been truly stunning if the EpiFix trial did not produce a spectacular improvement vs. “standard of care” in the older and fatter people with larger wounds.

It should also be noted that much more reliable results could have been obtained with a proper trial. The original trial was slated to encompass 80 patients. This is already quite small, but ultimately the study only included 25 patients, with a mere 13 patients treated with EpiFix grafts. They then compared the results to a mere 12 patients who happened to be older, fatter and had larger wounds.

The point is that as studies go, this one should not be viewed as being even remotely conclusive. It delivered results that should have been 100% expected – and in a population size that was too small to even matter.

What investors need to understand is this:

As noted above, these amnio products are treated as HCT/P products and as such do not require clinical trials. So what was the point of this study if it was not to pursue a clinical trial? The trial design was so faulty that it clearly would not have passed muster if it were to eventually be used for legitimate clinical trials.

Clearly, it served more of a marketing purpose than a regulatory purpose. The study and a follow-up has been published and has then been subsequently publicized by MiMedx. In November, MiMedx stated that

 

A competitor recently announced that the clinical study of their products showed that only 52% of their patients both healed in 12 weeks and remained healed at the subsequent 12 week follow-up. An optimal treatment for DFU would be one that supports both rapid and long-term healing. With 94.4% of DFUs remaining healed approximately one year after treatment, we believe our EpiFix® allograft is a clinically effective and economic solution to these needs.

 

In January, skin substitute competitor Organogenesis (maker of Alpigraf)announced that it had acquired the other major competing product (Dermagraft) from Shire Pharmaceuticals. Together, these two products dominate the market for skin substitutes.

So how do their products compare in terms of clinical data ?

For Dermagraft, we can see the that the pivotal study was far larger and more rigorous. It involved 314 patients in multiple centers (as opposed to the 25 patients in one center for EpiFix).

The study also noted that

 

If the study ulcer had not decreased in size by more than 50% during the next 2 weeks and the patient met all other inclusion and exclusion criteria, the patient was randomized into the study.

 

In other words, this competing study took the approach of only attemptingto test on patients who had very persistent and resistant diabetic foot ulcers. They deliberately selected the most challenging patients in an attempt to genuinely see if the treatment would provide a meaningful benefit. This is as opposed to trying to find the patients who would quite obviously be healed as quickly as possible. The result is that the blatant “marketing benefit” is naturally less spectacular.

Likewise, the study for Apligraf included 208 patients, and it is noted that it deliberately “excluded patients who exhibited rapid healing“.

MiMedx management has repeatedly made reference to the “published studies” which tout its product. Yet, it should be clear from the demographics of the 13 patients who were treated in a single site that these studies possess predictable marketing value to a much greater extent than they do scientific rigor.

One might wonder what sort of doctor/scientist would put his name on such a tiny and skewed study. The name of the lead author was Charles Zelen, and it turns out that he was the lead author on three of the six “clinical publications” that are listed on MiMedx’s website. The other three were co-authored by Donald E. Fetterolf, who happens to be chief medical officer at MiMedx. These six studies are the only “clinical publications” listed on the MiMedx website.

The point is that it is very easy to write a “study” and submit it to a specialized journal such as the “International Wound Journal” or the “Journal of Wound Care”. The study will, of course, be published. And then companies such as MiMedx get to make simple statements touting their publication in these journals. It is easy and guaranteed marketing material, even when it lacks the scientific rigor of legitimate FDA trials.

Why should investors care?

The reason to care is that the FDA has already demonstrated that it is cracking down substantially on inappropriate marketing and other practices by those in the skin substitute market. We saw this with the FDA untitled letter for MiMedx in September. But (not by coincidence) we saw the same thing at Osiris (OSIR) for its own skin substitute. An FDA untitled letter was issued to Osiris in October, just one month after MiMedx.

Investors can decide for themselves if the claims being made by MiMedx are well-substantiated given the tiny trial size and the skewed demographics of the participants. They can also decide for themselves what will be the impact of any decision by the FDA to require more rigorous and perhaps fully formal trials.

Understanding the new world of Medicare reimbursement

On November 29th, MiMedx put out a press release to announce that “the Company applauds the Centers for Medicare and Medicaid Services’ (CMS) new methodology for the reimbursement of skin substitutes” which had been released two days earlier.

There are really only two components of the CMS announcement that need to be understood.

The first component is the fact that for the remainder of 2014, EpiFix will retain its Pass Through Status for its third and final year. In effect, the new reimbursement policies will not affect reimbursement at all for the duration of 2014. EpiFix already had Pass Through Status for the past two years, and three years is the maximum allowable. This continuation is indeed moderately favorable for EpiFix, but the duration of only 1 year means that its impact will naturally be limited. But the market has basically priced in the scenario that MiMedx is going to have a permanent cost and reimbursement advantage over its competitors. This has led to inflated expectations for revenues.

In addition, MiMedx was not the only one to receive Pass Through Status. The market seems to have ignored this as well. Osiris was actually granted an additional two years of Pass Through Status, even though its product is widely regarded as among the most inferior of the products on the market. (One key takeaway from this observation is that Pass Through Status is basically being awarded to products that are simply “new” as opposed to being actually “better”.)

The second component is more complicated – and more important. CMS will now be introducing a two-tiered reimbursement system, which will dramatically alter the competitive landscape.

Anyone who is contemplating a long or short investment in MiMedx needs to understand the full details of this new policy adjustment. The text of the November 27th announcement can be found here at the CMS.gov newsroom and the fuller versions here.

Under the “old” system, reimbursement was calculated as average selling price (“ASP”) +6%. Under the “new” system, reimbursement will be split among two types: high cost and low cost.

The old system of ASP+6% basically incentivized the market leaders (such as Shire and Organogenesis) to manufacture one-size-fits-all sheets of skin substitute. As a result, they produced sheets in standardized sizes (ie. cheaper to manufacture) and in sizes that were too big (i.e. reimbursed at cost plus, so maximizing revenues). The predictable result was massive amounts of waste when 40 sq cm of standardized substitute had to be purchased just to treat a wound that was 2-3 sq cm in size.

Many may find it galling to know that such a system of perverse incentives was in place and running. These manufacturers were clearly incentivized to only produce their products in a size that guaranteed substantial overcharging and waste. But we should also be happy that the once-flawed system has been analyzed and tweaked to reduce product waste and economic waste. At least the supervisory feedback function has had the desired effect.

Under the new system, “high-cost products” are those with an ASP of $32/sq cm or higher. These will be reimbursed at $1,371.19 for up to 100 sq cm of product. Wounds over 100 sq cm will be reimbursed at a maximum rate of $2,260.

“Low-cost products” are those with an ASP below $32 per sq cm. They will be reimbursed at a rate of up to a maximum of $409.41 per 100 sq cm of product.

Understanding the competitive response to the CMS changes

Just after the CMS announcement (and – of course – just prior to the equity offering), small cap investment bank Craig Hallum put out a “quick note” to explain the implications of these massive changes on MiMedx. The note was just one-page long and noted the following:

 

The two market leading products, Apligraf® and Dermagraft®, are not offered in a size-appropriate graft which is the chief reason for $100M in annual wastage prompting this decision by CMS. Prior to this new regulation, all reimbursement was set at ASP +6% which is why the competition was able to establish market share in the first place.

While the final rule paints a slightly better picture for MDXG’s competitors, they will still have to cut prices substantially or file PMA supplements in order to remain a competitive force in the years ahead. With this new rule, we believe MDXG could garner an incremental $50M in revenues over the next several years as the Company establishes a dominant position in the wound care marketplace.

 

This justification was used to state a $9.00 target (50% above the prevailing price at the time).

Basically, what Hallum is saying is that the competitors will simply to continue to offer wrong-sized products at non-competitive prices despite new and different incentives to offer smaller products at rational prices. Ergo: the Craig Hallum banking client should be expected to rise by 50% (just in time for the company to raise $39 million in an equity offering).

This assumption is pure and unadulterated nonsense, and we will soon see that it will not play out in reality. It was nothing more than an excuse to justify a high share price target ahead of an equity offering in which Hallum hoped to be well-paid. The competitors will certainly change their product offerings in order to provide an economically rational (i.e. size-appropriate) product which will be reimbursed at proper rates accordingly.

Craig Hallum does include a minor mention of these competitors who would enjoy a “slightly better picture” in its one-page report. But it notes that “Dermagraft” by Shire and “Apligraft” by Organogenesis are nearly 2-3x as expensive as EpiFix, while they are to be reimbursed at the same rate.

Craig Hallum ultimately was selected as a lead manager on the equity offering alongside bookrunner Canacord and pulled in substantial fees a few weeks later, just as the share price was soaring on the back of upgrades like this.

Looking at past examples – history is repeating itself

Readers who have followed my articles over the past year may remember that I have repeatedly called out similar research nonsense from Craig Hallum during 2013. Each of my articles said the same exact thing: over-bullish research calls were preceding investment banking deals by Hallum clients. The stocks soared, the equity was issued. Craig Hallum got paid their fees. Then the stocks tumbled.

Past Hallum examples (which I wrote about) included TearLab (TEAR), Neonode (NEON) and Uni-Pixel (UNXL). Readers will also remember that I was proven right about each one of these stocks within either a few days or a few weeks at most.

From the time I wrote about each of these Hallum stocks, each is now down by at least 20-30% – despite predictions of double-triple digit gains by Craig Hallum.

In each case, these Hallum bull calls came just in time for Hallum to help them issue stock. Hallum made millions in total fees. In each case, the bullish predictions came unraveled not long after the equity offering was completed.

Following the equity offerings, these banks tend to provide a few weeks of bullish support for their banking clients, helping to support the stock. If they did not do so, they would certainly aggravate their hedge fund clients who bought into the deals.

But we can see that reality is typically quick to set in, and the share price cannot sustain itself forever once real revenues fail to materialize as predicted in the bullish (pre-financing) research reports.

Perhaps a few examples would help to illustrate.

Prior to recent earnings, Hallum had an $18 target on TearLab. As with MiMedx, this was apparently based on the supposedly stellar growth prospects. What about Canaccord? Canaccord had a $19 target. Even though the growth prospects were challenged and the valuation was already excessive, TearLab’s investment bankers, by coincidence Hallum and Canaccord, raised $35 million for TearLab, making several million in fees. The offering price was $13.50. Since that time, insiders have been steady sellersof shares at prices around 40-50% below the banker targets.

On November 8th, I published an article entitled “Earnings Miss Will Send TearLab Sharply Lower“, which showed that my own research (including phone calls to dozens of eye doctors who were supposedly TearLab customers) indicated a very high likelihood of

 

a share price decline of at least 25% to around $8.50 or below.

 

The share price had been sitting at around $11.00 at the time and the earnings were (as expected) the catalyst for a quick and sustained sell-off. Shares of TearLab now trade for around $6-7 – down by around 40% since my report, but around 66% below the targets put forth by Hallum and Cannacord, which still sit at $18-19.

On Uni-Pixel, I also called out the Craig Hallum client as being the subject ofirrational and unsubstantiated promotion. At the time, the share price was around $15. As with MiMedx (and TearLab), Hallum repeatedly raised their share price targets on Uni-Pixel (ultimately to $58, up from a share price of $10). This caused the share price to trade to over $40. Of course, this was just in time for Uni-Pixel to complete an equity offering of over $30 million with Craig Hallum an investment banker. Then, of course, the company failed to live up to the sky-high projections put forth in the (pre-financing) Hallum research. After the equity offering was complete, the stock quickly began to plunge and now sits at around $9.00. Hallum has since (i.e. after collecting its investment banking fees) reduced its price target on Uni-Pixel to just $9.00 from $58.00 – certainly a significant (post-investment banking) target revision.

But wait… I’m not done.

In September, I published a warning about Hallum client Neonode . Despite losing the majority of its revenues and its largest client, Hallum saw fit to upgrade $5.00 Neonode to a $10.00 target price. The stock soared (even though Neonode had just delivered a painful earnings miss). What followed was quite predictable. A Craig Hallum-led equity offering in which management were the largest sellers. As with MiMedx, Neonode management was very eager to sell their personal holdings at current prices even though Craig Hallum was telling outside investors that the stock will continue to soar by double-digit percentages. When I wrote about Neonode, the stock had been sitting at around $7.50. The stock since fallen to around $5.50-5.70 (a decline of around 25% – and a shortfall of 50% vs. the latest Craig Hallum target.)

But let’s not forget about Canaccord’s involvement here.

As we look at the ratings on MiMedx by Canaccord and Hallum, we can see that Canaccord started at $6.00 in October but doubled this to $12 by December, the month of the equity offering. Hallum started in March at $7.00 and then raised to $9.00.

The charts tell the story best. Here are the charts of the research-driven run-ups before the predictable equity offerings. The charts also show thepredictable plunges once the hyper-optimism for these high-priced “growth stocks” fails to result in concrete results.

(click to enlarge)

The pattern, for those who might have missed it, is that a money-losing company (who happens to need to raise money) is bestowed with a series of sky-high share price targets. When the share price rises, the target is simply raised higher.

Then the company issues a large amount of stock (paying its banker/research provider millions in fees).

The stock is typically strong for a while, which is clearly good for the hedge fund clients who bought the deal.

But then when the excessive optimism fails to translate into reality, the hedge funds disappear and the stock inevitably falls back to where it began.

Readers should please keep in mind that the examples above were not cherry-picked for the convenience of this article. These examples were given because they were all stocks which I wrote about in 2013 and where I warned about this exact sequence of events well before they materialized.

MiMedx is the exact same example. There are overly bullish forecasts being put forth despite commonsense evidence to the contrary which is patently obvious. Now that MiMedx has already raised its $39 million in proceeds, and now that the CEO and the largest outside shareholder have begun selling stock, there is every reason to expect substantially more downside to come in the next few weeks.

Conclusion – what is MiMedx worth?

As with TearLab, Neonode and Uni-Pixel (among others), MiMedx has achieved a spectacular valuation of 10-20x sales based on hyper-bullish projections for future growth which will supposedly be driven by some tremendous recent catalysts.

But the analysts providing these numbers also happen to be the investment bankers to the company and stand to make millions in fees if the company selects them to underwrite the offerings.

By contrast, investment banks (as well as research analysts) have no method of monetizing any level of accuracy in their stock picks.

These analysts have blatantly ignored the flaws in MiMedx’s “clinical study” and have turned a blind eye toward the very obvious competitive reaction that will occur following CMS reimbursement changes.

These same banks were among the ones who made identical leaps of faith in projecting triple-digit rises in the shares of TearLab, Neonode and Uni-Pixel (among many others).

Best-case scenario is that MiMedx continues to execute and that the valuation finds a sustainable level. This probably puts MiMedx at around $4-5.

But worst-case scenario is that there is fallout from the FDA in terms of regulating one or more products and that the competitive response from the well-funded competitors is in line with what should be expected.

If this is the case, then MiMedx will not be profitable at any time in the near future and the share price is more likely to stabilize at around $3.00.

 

Disclosure:  The author is short MDXG

Trouble Brewing at Farmer Bros Coffee (FARM)

spilled coffee

Background

Farmer Brothers coffee (FARM) was founded in 1912 by Roy E Farmer. The company is headquartered in Torrance, CA, which location also serves as a manufacturing and distribution hub.

The company became publicly traded in 1951 and for a while was profitable and paid a dividend. Yet the company has now failed to generate any annual profit since 2007. In 2011, the company cancelled its dividend, citing ongoing financial circumstances.

The company is not widely covered on the research side, while much of the institutional holdings consist of passive index funds. As a result, the share price has gradually crept up from a low of around $7 in 2012 to over $24 by late 2013. Much is this has been due to strong performance by other stocks in the coffee space such as Starbucks (SBUX) and Green Mountain Coffee (GMCR).

Farmer Brothers typically trades up gradually on very light volume and there have been almost no large, event-driven moves in it. There is virtually no short interest in the stock, with only 1-2% of the float being sold short. The market cap is currently just over $300 million.

The company has occasionally reported individual quarters of profitability. But as we saw last year, this was driven by one time gains, such as sales of real estate, and not due to sales of coffee.

This gradual rise in the share price has occurred despite a mounting series of problems at Farmer Brothers, including the following:

  • recent forced restatement of 3 years of erroneous financials
  • disclosure of a material weakness in internal controls
  • significant speculation in coffee derivatives leading to large and consistent losses
  • resignations from key members of the finance team
  • an unfunded pension liability of $40 million
  • short sighted financial practices such as “self insuring” to minimize near term insurance expenses
  • inventory accounting which maximizes reported profit but which conflicts with the actual flow of goods
  • significant involvement and influence from late generation members of Farmer family despite little to no business experience
  • virtually no share ownership by any members of management

Key catalyst for a sharp decline at Farmer Brothers

The year 2013 saw two significant resignations from the finance team at Farmer Brothers. Also in 2013, the company was forced to restate 3 years of financials due to improper accounting for its very large pension obligations. The financials had all been previously signed off on by auditor E&Y as well as by management.

On December 30th, 2013, Farmer Brothers announced that it would be switching auditors from E&Y to Deloitte. The immediate impact of this announcement was largely muted due to the fact that it was released after the close of markets on the night before New Years Eve, along with the fact that the stock is not widely covered.

This new switch creates a tremendous risk that a new auditor will reevaluate current and past accounting treatment for items which may be considered aggressive and murky (including pension and derivative accounting) and will therefore require another (and potentially larger) financial restatement. Additional items such as the debatable use of LIFO accounting (which helps the company boost gross margins) should be more clear cut in the eyes of a new auditor. As most investors know, the use of LIFO in an environment of falling prices will always boost margins. Yet companies who sell perishable goods must always sell these goods as close to First In First Out in order to avoid unnecessary spoilage. In any event, this treatment is not consistent with major competitors. This will be demonstrated below.

Any time that a firm with a history of financial troubles and aggressive accounting switches auditors, it should be considered a greatly heightened risk factor for the share price. Initial audits by new auditors are generally considered to be the most thorough and stringent. The items detailed below should be evaluated in the context of how they will be viewed upon an initial audit by new auditor Deloitte.

Overview of financial concerns

Each of the concerns shown above is explained in detail below. However, the big picture can be summarized as follows:

It has now been an ongoing problem for years that the true net income (loss) being experienced at Farmer Brothers is more substantially influenced by things like pension and derivative accounting treatment than it is on the actual business of selling coffee itself.

Much of this has been missed by the very passive investor base because the impact of these items on Farmer Brothers is taken “below the line”. It is buried in “other comprehensive income” and not treated as a part of the “net income (loss)” line item.

As we will see below, these accounting items significantly outweigh the overall effect of what Farmer Brothers is supposed to be doing – ie. simply selling coffee.

Forced restatement of 3 years of financials

On September 11th, 2013, Farmer Brothers announced that its past 3 years of financials should no longer be relied upon due to significant errors in is reporting for post retirement benefits. Farmer Brothers has been in business for over 100 years and continues to employ nearly 2,000 people, such that its pension obligations are meaningful, standing at over $130 million.

As part of the restatement it was forced to disclose a material weakness in its internal controls. It was also disclosed that there were certain additional errors found in its reporting, but they deemed that these errors were “immaterial”.

It should be noted that auditor E&Y had previously signed off on all of these erroneous financials. Investors now have adequate reason to be concerned that a fresh look by Deloitte will uncover additional items that had slipped by under the watch of E&Y for whatever reason.

The items which had been determined by management and E&Y to be “immaterial” could certainly be considered to be quite “material” for anyone who owns stock in Farmer Brothers. The Net Income (Loss) was restated by as much as $3 million, Liabilities were off by as much as $13 million, Total Comprehensive Loss was off by as much as $9 million, while Total Equity was off by as much as $15 million.

These amounts would certainly appear to be substantial for a company which had a market cap of around $120 million last year. The current market cap has risen to over $300 million.

The notice of this restatement came at the very last minute for Farmer Brothers, with just 2 days left before it was required to file its 10K in September. As a result, the company filed Form12b-25 to get an extra 15 days to file its 10K.

As that date rolled around, the company missed the new deadline once again, with the result that it received a NASDAQ delisting notice which triggered events of default with its banks. These were then modified by the lenders subject to remedying of the delisting.

When the 10K was finally released, it revealed that the process of restatement had had significantly negative impacts on the company. The magnitude of these impacts should be read carefully, because they will become highly relevant below.

As disclosed by Farmer Brothers:

THE RESTATEMENT OF OUR HISTORICAL FINANCIAL STATEMENTS HAS ALREADY CONSUMED, AND MAY CONTINUE TO CONSUME, A SIGNIFICANT AMOUNT OF OUR TIME AND RESOURCES AND MAY HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS AND STOCK PRICE.

We cannot be certain that the measures we have taken since we completed the restatement process will ensure that restatements will not occur in the future. The restatement may affect investor confidence in the accuracy of our financial disclosures, may raise reputational issues for our business and may result in a decline in share price and stockholder lawsuits related to the restatement. The restatement process was resource-intensive and involved a significant amount of internal resources, including attention from management, and significant accounting costs.

WE CANNOT ASSURE INVESTORS THAT WE WILL BE ABLE TO FULLY ADDRESS THE MATERIAL WEAKNESS IN OUR INTERNAL CONTROLS THAT LED TO OUR RESTATEMENT, OR THAT REMEDIATION EFFORTS WILL PREVENT MATERIAL WEAKNESSES IN THE FUTURE.

We have identified control deficiencies in our financial reporting process that constituted a material weakness in our controls over our accounting for and reporting of other postretirement benefit obligations, leading to the restatement of certain prior period financial statements. Specifically, our controls did not properly identify the failure to apply generally accepted accounting principles with respect to the accounting for death benefits and the related cash surrender value of life insurance, and did not properly detect when changes or amendments to other postretirement benefit plans occurred that should have resulted in changes to the related benefit plan obligations. As a result, material errors to the recorded postretirement benefit liability, postretirement death benefit liability and cash surrender value of life insurance purchased to fund the postretirement death benefit occurred and were not timely detected.

The restatement was obviously a bad thing. It was embarrassing. It was unprofessional. It was expensive. It created a significant drain on internal resources away from managing the business and trying to make money by selling coffee.

But here is the real point of concern:

The delisting notice was received on October 3rd. As a result, most shareholders should be outraged that just 5 days later, the company awarded record bonuses to all members of management, which in each case were in excess of 100% of their target amounts as set in their incentive plans. Again, this was almost immediately after the public disclosure of the significant impact of their erroneous accounting and management decisions.

 

Officer  Maximum target bonus Actual bonus (2013) %
Michael H. Keown
 $     475,000 536,274 113%
Mark A. Harding(2)
 $     128,250 142,908 111%
Thomas W. Mortensen(2)  $     128,250 142,908 111%
Hortensia R. Gómez  $      60,000 66,029 110%

In addition to the amounts above, CFO Mark Nelson was also paid a bonus of over $36,000 as a partial year bonus even though he had only been employed at the company for a few months prior to the June 30th Fiscal Year end. This was 112% of his target pro rata bonus.

In any ordinary public company, the substantial multi year restatement would have likely been a reason for members of management to feel lucky to keep their jobs and simply receive a zero bonus as a warning. This is particularly true given that 2013 was the 7th consecutive year of net losses for Farmer Brothers. As we saw from the disclosure above, the impact of these restatements was very substantial.

When management consistently fails at their jobs, they are supposed to be sent a strong message to change or else they are replaced.

But at Farmer Brothers, the company continues to receive strong influence from the family descendents of Roy Farmer, who founded the company over 100 years ago. It is not really run much like an independent public company which is supposed to serve the interests of shareholders.

Roy Farmer’s son (also named Roy) had previously served as chairman. His two daughters (Jeanne Farmer Grossman and Carol Farmer Waite) have more recently served on the board of directors. Ms. Farmer-Waite’s son currently holds the somewhat ambiguous title of “Vice President of Coffee” and earns $270,000 per year.

As shown below,these later generation members of the Farmer family have demonstrated no qualifications to run this company. Had they not been born with the last name “Farmer” there is clearly no conceivable way they would be in any position to be managing any public company.

Ms. Farmer-Grossman is Chairman of the Compensation Committee and would therefore have been responsible for setting the record bonuses following the restatement of 3 years of erroneous financials and the NASDAQ delisting notice. She would also be responsible for signing off on the $270,000 compensation awarded to her nephew who serves as “Vice President of Coffee”. Ms. Farmer-Grossman also sits on the Nominations Committee of the board.

In justifying her significant board roles and decision making authority, the latest proxy notes that her experience is as a “retired teacher and homemaker” age 63, who received her undergraduate degree in education. If she has any business experience, none is cited in these credentials. Likewise, her sister Carol Farmer Waite is also a retired school teacher.

In clarifying qualifications, the proxy states that “Ms. Grossman’s qualifications to sit on our Board include her extensive knowledge of the Company‘s culture and sensitivity for Company core values…”

By being born into the Farmer family, and by virtue of owning roughly $20 million in stock, Ms. Farmer-Grossman has been granted a position of authority and responsibility on two board committees. The ongoing management of Farmer Brothers as a family fiefdom by those with zero business experience is what has led to consecutive years of ongoing net losses and cancellation of the dividend as well as a massive and amateurish financial restatement due to poor supervision of the finance team.

In fact, as we will see below, there are much larger problems brewing at Farmer Brothers which have also likely been swept under the rug. Although these have been given scant attention by management and the board, they will certainly be closely evaluated during the first audit by new auditor Deloitte.

Speculation in coffee derivatives leading to large consistent losses

Farmer Brothers frequently refers to its large purchases of coffee derivatives as being for “hedging” purposes. There are several obvious signs that these purchases have more to due with speculative bets on coffee prices than they do with hedging sales of coffee products.

Farmer Brothers should not be in the business of gambling on the direction of commodity markets. Even professional commodities traders find it hard to do well in these volatile markets. Moreover, it is clear that Farmer Brothers has demonstrated a consistent habit of placing bets which are very large and very wrong and which have repeatedly cost the company tens of millions of dollars.

Rather than just running the business, Farmer Brothers has tried to “call the bottom” on coffee prices and has hoped to profit by loading up on large amounts of coffee derivatives. The problem is that the price of coffee has seen a continuing slide for 3 years running and there does not appear to be any end in sight in the near term.

The Wall Street Journal recently ran an article entitled “As Coffee Prices Decline, Investors Brace for More

It noted that:

Coffee prices have tumbled 20% this year, capping the biggest two-year plunge in a decade and highlighting commodity markets’ struggle with a supply deluge.

Coffee prices haven’t fallen for three consecutive years since the early 1990s. Since 2011, coffee prices are down 49%. That is the largest two-year decline since 2000-2001, when prices fell 63%.

Investors have bailed out of bullish bets and as a group are betting for prices to keep falling, according to Commodity Futures Trading Commission data.

The following is a graph which illustrates the magnitude of the 3 year continuous decline in coffee prices:

 

 

Were it not for poor speculation, this type of decline should have actually been a major boon to Farmer Brothers. The WSJ noted that:

Meanwhile, retail prices for bagged coffee and lattes have stayed relatively steady, a boon for roasters and food companies that are able to capitalize on lower coffee costs.

So just how bad has the impact been from wrong way derivative bets by Farmer Brothers management ? Here are a few examples.

In May, the company released 9 month results in which it proudly noted that its gross margin had improved by 4%. However this was during a time in which coffee prices (as disclosed by the company) had declined by more than 30%. Even if Farmer Brothers had passed on the majority of the real market savings to its customers, it still should have shown a dramatic surge in margin, but the company enjoyed almost no benefit at all.

It also announced that losses on coffee derivatives for the 9 months had already exceeded $10 million, an even larger loss than the $8 million in the 9 months from the preceding year.

The size of this loss was attributed to a “four fold increase” in the number of coffee related derivative contracts purchased covering 34.8 million pounds of coffee vs. 9.4 million pounds of coffee in the prior year. Yet revenues had increased by less than 2%.

When coffee purchases increase by 300% to cover a 2% increase in sales, this is called speculation, not hedging.

Beyond the past losses, it is disclosed that it expects to continue losing more on the derivatives:

Based on recorded values at September 30, 2013, $8.2 million of net losses are expected to be reclassified into earnings within the next twelve months.

As of April 1st, 2013, the company began implementing procedures to apply ASC 815 for its “derivatives and hedging”. The stated goal of this is to

minimize the volatility created in the Company’s quarterly results from utilizing these derivative contracts and to improve comparability between reporting periods

Investors who are interested can click here to read the accounting guide from PWC on this subject. Those who choose to click the link will see that the summary guidance is over 500 pages long.

There are several points from this. First off, the goal of these accounting treatments as implemented by the company should arguably not be to “minimize the volatility created in the quarterly results”. Instead, it should be to present the fair value of the derivatives activity in which the company is engaging. That way there will be no sudden and dramatic “mark to market” surprises in coming quarters.

Perhaps of greater importance is the fact that this 100 year old company is now engaging in more sophisticated and risky activities which were likely never envisioned by its founder. When the founder had been running this company in simpler times, Farmer Brothers was consistently profitable and paid a healthy dividend. The diversion into derivatives speculation has coincided with the company canceling its dividend as it continues to lose money each year.

The current installment of Farmer family descendents into roles of responsibility does not help matters. Based on any disclosure of their educational and professional backgrounds, most investors would find it highly unlikely that either of the retired Farmer homemakers and school teachers would be able to navigate and explain the nuances of derivatives speculation and the appropriateness of the resulting accounting issues for transparency to investors. The same could likely be said for the Farmer who serves as “Vice President of Coffee”, but whose background is not disclosed.

As we saw in October, when there were suddenly large losses and restatements, these individuals were, not surprisingly, caught 100% off guard.

These observations should in no way be construed as personal aspersions against the current members of the Farmer family. The point is simply that as a public company, these family members should not be entitled to oversee the business when they have not demonstrated any relevant qualifications. The results of their oversight have been ongoing losses, financial restatements and risky derivatives speculation by management which have then been rewarded with excessive compensation.

Perhaps of greatest importance is the fact that many investors seem entirely unaware of the derivative losses. For 2013, Farmer Brothers reported an accounting net loss of $8.4 million. But this entirely ignoresadditional “Deferred losses on derivatives designated as cash flow hedges” which totaled an additional $7.9 million.

The additional losses incurred from derivatives was nearly as large as the total loss from selling coffee in the operating business. But this is only disclosed “below the line” in Other Comprehensive Income (Loss) and can be found on page 38 of the 10K.

How concerning is the pension benefit restatement ?

Companies which employ many people and which have been in business for an extended period of time typically suffer disproportionately from the burden of post retirement benefits. The most widely recognized example of this would be General Motors.

Farmer Brothers currently employs around 1,800 people. But having been in business for over 100 years (more than 60 years as a public company), the company has a fairly large built up obligation from post retirement benefits.

As of its fiscal year end, Farmer Brothers had a Projected Benefit Obligation(“PBO”) of $132.2 million while the Fair Value (“FV”) of its plan was just $92.4 million.

As a result, its plan is under funded by about $40 million.

The company disclosed that

We expect to make approximately $1.3 million in contributions to our single employer defined benefit pension plans in fiscal 2014 and accrue expense of approximately $0.7 million per year beginning in fiscal 2014. These pension payments are expected to continue at this level for several years, and the current economic environment increases the risk that we may be required to make even larger contributions in the future.

The accounting for post retirement benefits is complicated and is subject to many management assumptions. As a result, many investors find themselves completely befuddled by it and find it easier to simply ignore these liabilities and expenses, focusing instead on the operating business which is easy to understand.

But for companies with obligations which are very large relative to their balance sheet, these expenses and liabilities can entirely outweigh the results of the operating business. This is what we ultimately saw with GM (although obviously GM is a very extreme example).

Point #1 – the pension obligations are very large relative to equity in the company

For Farmer Brothers, the size of the PBO liability (using current assumptions) is $132 million. Total equity for Farmer Brothers is just $84 million. The point is that this $132 million obligation is very large relative to its equity.

Point #2 – the obligations and underfunded status are simply management’sestimates

The second point to be made is that this already large obligation is simply anestimate of what the company will actually owe and is subject to assumptions which are being put forth by Farmer Brothers management. The biggest point of sensitivity for the PBO is the assumed discount rate. The lower the rate, the higher the obligation becomes. We are currently still in an environment of extremely low interest rates. Yet the company assumes rather high discount rates of 4-5%. This results in a projected benefit obligation which is lower than should really be the case.

In looking at the largest one of the pension plans (the “Farmer Brothers Plan”), each 0.5% decrease in the discount rate increases the PBO by $8 million. (See page 24 of the 2013 10K) So if the company were to instead assume a 3% discount rate, the PBO would rise to around $150 million. A 2% discount rate would cause it to rise to around $166 million. This then comes to double the shareholders equity in the entire company.

For reference, 10 year treasuries are currently sitting at around 3%, which are still at 3 year highs. One year ago (including the reference period for the current 10K which assumes 4-5%) treasuries were at just 1.76%.

The level of underfunding can be analyzed the same way. With a Fair Value of $92 million, the pension plan appears to be underfunded by $40 million using current management assumptions. But with a 2% discount rate, the level of underfunding alone would be around $75 million (almost equal to the total shareholders equity for the entire company).

Investors should also note that there are multiple plans to consider: the “Farmer Brothers Plan”, the “Brewmatic Plan” and the “Hourly Employees Plan”. For simplicity, the numbers above refer only to the Farmer Brothers Plan because it is notably the largest.

So investors need to ask themselves how large is Farmer Brothers actual pension benefit obligation and how large is the actual shortfall? Investors also need to handicap how and when Farmer Brothers will end up funding the shortfall. Given that the company has failed to generate a real profit since 2007, it seems more likely that the company may be forced to issue a substantial amount of equity in order to remedy this shortfall.

Point #3 – Fluctuations in pension obligations outweigh the total income / loss for Farmer Brothers

As with the deferred losses on derivatives, the changes in the funded status of the pension plan are treated as “Other Comprehensive Income (Loss)” and can be found on page 38 of the 10K.

In 2013, the fluctuation in the underfunded status of the pension plan amounted to an improvement of $10.9 million. This is greater than the magnitude of the entire reported net loss ($8.5 million) for all of the company’s operating business of selling coffee. But because this is reported “below the line”, most investors are entirely unaware of the magnitude of these swings.

And by looking at the (now restated) numbers for 2012, we can see that the funded status in that year fell by $26.5 million, which was basically equal to the $26.5 million loss the company incurred for its entire operating business of selling coffee.

So again, the point here is that changes in the status of the pension plan (which are heavily dependent upon management assumptions) have been of equal or greater impact on Farmer Brothers than its entire business of selling coffee.

As a result, the fact that Farmer Brothers has been unable to properly estimate and account for its pension liabilities and was forced to restate 3 years of financials is of very extreme significance. In fact, it is of far more consequence than the issue of how much coffee is Farmer Brothers selling.

The fact that the company has now restated these financials with E&Y should be of very little comfort. E&Y missed all of these problems in the first place, blessing the 3 years of results. Shortly after E&Y reviewed and once again blessed the restated numbers, they were they replaced as the auditor for Farmer Brothers.

Given the huge impact on the financial health of Farmer Brothers, this will obviously be the first area which is subject to scrutiny by new auditor Deloitte.

Looking at past behavior of management and the board

As shown above, the restatement of 3 years of financials was announced in September. But there are very clear signs that management was well aware of these problems at a much earlier date.

As far back as May (4 months before the restatement was announced), the company had suddenly amended and restated the audit committee charterwithout any explanation for why these changes were suddenly deemed necessary.

Even a brief read of this document filed in May will strongly suggest that the board already knew that there were problems with the ongoing financial statements and was looking to shift blame to the auditor and towards management and away from its own members.

For example, the restated audit committee charter states that

Additionally, the Committee recognizes that the Company‘s management, as well as the Company‘s independent auditors, have more time, knowledge and more detailed information concerning the Company than do Committee members.

Consequently, in carrying out its oversight responsibilities, the Committee isnot providing any expert or special assurance as to the Company‘s financial statements or any professional certification as to the work or independence ofthe Company‘s independent auditors. In addition, auditing literature, particularly Statement of Auditing Standards No. 100, defines the term “review” to include a particular set of required procedures to be undertaken by independent auditors. The Committee members are not independent auditors, and the term “review”as applied to the Committee in this Charter is not intended to have that meaning and should not be interpreted to suggest that the Committee members can or should follow the procedures required of auditors performing reviews of financial statements. Furthermore, the Committee’s authority and oversight responsibility do not assure that the audits of the Company‘s financial statements have been carried out in accordance with GAAS.

Again, the timing of such a strange document is noteworthy.

This document was released just 4 weeks before the end of the fiscal year ended June 30th, 2013. This was the 10K which included the 3 years of restatements. It seems quite clear that the board had already been informed of problems with the previous financials.

Clearly all elements of the business (including the financial statements) fall under the responsibility of CEO Michael Keown. But the detailed day-to-day involvement would have largely been the responsibility of former CFO Jeffrey Wahba.

It should be noted that Mr. Wahba resigned from the company earlier in 2013, and continued on as a consulting CFO until May 22nd. One week after the end of the CFO’s employment (following 3 months of consulting by him) the company chose to issue the audit committee restatement.

As we can see, that restated audit committee charter clearly shifts blame towards management and the auditor. By the time the restated document was released, the CFO had already discontinued his employment. And now, by the end of the year, the auditor has already been replaced. The point is that in May, these actions indicate that the board was already aware of the problems. They had shifted the blame away from themselves and now they have completed the process by eliminating the CFO and the auditor.

But here is the kicker. Although management and the board certainly knew about these problems, investors were entirely in the dark. In May, the share price had been trading as low as $13. By the time the auditor was replaced, the share price had traded to over $24.

Despite impending problems, CFO Wahba reaped a large windfall upon his departure. Much of this would clearly require board approval from the compensation committee which is chaired by Ms. Farmer Grossman.

Technically, Mr. Wahba resigned his employment with the company effective February 28th, 2013. But he continued to provide his “consulting services” to the company as CFO into May at a rate of $285 per hour. For this few month period of service (which ended right as 3 years of his financials) were about to be restated, he received $795,000 in compensation. For reference, in 2012, Mr. Wahba worked for the entire year on a full time basis and received a full year bonus and his total compensation was $1.1 million. The point is that Mr. Wahba was extremely well paid for doing a short duration of work – which then culminated in the restatement of 3 years of financials which were signed under his watch. It is yet another example of Farmer Brothers providing excessive cash compensation to members of management despite dismal performance.

But the real payoff for Mr. Wahba came when he sold all of his stock. Even though he was still providing his consulting services to the company through May, Mr. Wahba sold all of his stock in company during the first week in March, immediately after he technically resigned. He sold 100% of his shares at prices of around $13, bringing in around $2 million.

On December 11th, Hortensia Gomez, the Vice President and Financial Controller sold 390 shares of Farmer Brothers stock for around $9,000. This amount is clearly not large, but based on the disclosure in the proxy, Gomez did not appear to have any other meaningful ownership of stock.

On the very next day, December 12th, the company filed an 8K to announce a “Separation Agreement” with Gomez. As with Mr. Wahba above, the terms of the separation appear to be very favorable for Ms. Gomez. Ms. Gomez will stay on for a transition period of about a month and will be paid severance of $150,000.

This announcement came just 2 weeks before the announcement that the auditor was being replaced.

On page 11 of the proxy, we can see that among all members of management, none of them have any meaningful ownership of stock in the company. Management members are in fact required by the company to own some amount of stock. But we can see that no member of management or the board (other than members of the Farmer family) hold even 1% of the shares in the company.

 

 

Members of the Farmer family continue to own around 37% of the outstanding shares, with Ms. Farmer Grossman holding 892,444 shares valued at around $20 million.

Management has demonstrated a strong preference for being compensated primarily in cash. For 2013, CEO Michael Keown received $1.6 million in compensation, mostly in cash.

Total compensation to management in 2013 came to around $4 million. To put this in perspective, management’s compensation alone amounted to around 50% of the company’s total loss of $8 million in 2013.

Farmer Brothers stock has been in the hands of the Farmer family members for generations now. They have shown no intention of selling substantial amounts of stock regardless of whether the price is high or low. The fluctuations on the share price therefore have very little impact on them at all.

But for members of management who do not already own stock, they have very little exposure to the long term share price movements. As a result of this, it creates the risk that they can be more focused on short term results which can be driven by pension accounting, derivatives speculation and other short term accounting techniques. When these provide any boost to the numbers, they are then compensated heavily and in cash.

Looking at the LIFO accounting

Any company which deals in perishable goods will invariably take steps to ensure that the goods they acquire are distributed as quickly as possible and that they are distributed in a “First in, First Out” (ie. “FIFO”) manner. This is common sense and is done simply to prevent spoilage. Farmer Brothers can certainly be expected to sell first the coffee it acquires earliest.

But from an accounting standpoint, the company has elected to report its inventory and COGS using the LIFO (“Last In, First Out”) method. This is particularly advantageous in a period of falling prices because they company always appears to be selling the cheapest coffee first, while holding as inventory the more expensive (“more valuable”) coffee.

The price of coffee beans of various varieties has been in a steady 3 year decline, with prices continuously falling by more than 50%.

If Farmer were to pay $2.00 per pound to buy coffee in January, but only $1.00 per pound to buy coffee in February, Farmer would then report that it is selling all of the $1.00 coffee before ever having to sell any of the $2.00 coffee. This means that gross margins are substantially higher because Farmer always appears to be selling the “cheapest” coffee first. It also overstates inventory because the “more expensive” coffee is held on the books.

LIFO accounting will always deliver superior accounting results in an environment where a company s seeing falling input prices. At the end of the year, Farmer then conducts what is known as a “LIFO Liquidation” where it attempts to “true up” this discrepancy. But because Farmer keeps buying more and more coffee, these older purchases at much higher prices are simply never reflected. This is true even though the physical coffee that was purchased at much higher prices was actually physically sold long ago. This means that the real margin is in fact much lower due to the higher prices paid for coffee at the time.

In any event, the ultimate impact of this LIFO accounting is not fully known until the end of each year, such that quarterly results can be misleading.

The company discloses this in the recent 10Q as follows:

Inventories are valued at the lower of cost or market. The Company accounts for coffee, tea and culinary products on the last in, first out (“LIFO”) basis and coffee brewing equipment manufactured on the first in, first out (“FIFO”) basis.The Company regularly evaluates these inventories to determine whether market conditions are correctly reflected in the recorded carrying value. At the end of each quarter, the Company records the expected beneficial effect of the liquidation of LIFO inventory quantities, if any, and records the actual impact at fiscal year-end. An actual valuation of inventory under the LIFO method is madeonly at the end of each fiscal year based on the inventory levels and costs at that time.

If inventory quantities decline at the end of the fiscal year compared to the beginning of the fiscal year, the reduction results in the liquidation of LIFO inventory quantities carried at the cost prevailing in prior years. This LIFO inventory liquidation may result in a decrease or increase in cost of goods sold depending on whether the cost prevailing in prior years was lower or higher, respectively, than the current year cost. Accordingly, interim LIFO calculations must necessarily be based on management’s estimates of expected fiscal year-end inventory levels and costs. Because these estimates are subject to many forces beyond management’s control, interim results are subject to the final fiscal year-end LIFO inventory valuation. The Company anticipates its inventory levels at June 30, 2014 will be same as of June 30, 2013 and, therefore, did not record an adjustment to cost of goods sold for the three months ended September 30, 2013. No adjustment to cost of goods sold was recorded for the three months ended September 30, 2012.

By contrast, Starbucks uses a more accurate moving average cost rather than LIFO. Likewise, Green Mountain Coffee uses a method which is in line with FIFO, as opposed to the unusual use of LIFO at Farmer Brothers.

In any event, during the recent multi year price decline in coffee, Farmer Brothers use of LIFO accounting has been able to benefit interim gross margins and is inconsistent with other players in the coffee space.

Self insuring to save money on insurance premiums

The LIFO accounting above is inconsistent with the physical flow of goods through Farmer Brothers. It is also a short sighted way to provide an apparent boost to gross margins.

Likewise, the company has chosen to self insure itself rather than pay full insurance premiums. This is the case even though the company has disclosed that it does not meet minimum credit criteria to participate in such a program in its home state ofCalifornia.

According to the 10K

In May 2011, we did not meet the minimum credit rating criteria for participation in the alternative security program for California self-insurers. As a result we were required to post a $5.9 million letter of credit as a security deposit to the State of California Department of Industrial Relations Self-Insurance Plans. As of June 30, 2013, this letter of credit continues to serve as a security deposit and has been reduced to $5.4 million.

The full impact of the decision to self insure against these substantial risks is large enough that it is included as its own separate risk factor.

WE ARE SELF-INSURED AND OUR RESERVES MAY NOT BE SUFFICIENT TO COVER FUTURE CLAIMS.

We are self-insured for many risks up to significant deductible amounts. The premiums associated with our insurance continue to increase. General liability, fire, workers’ compensation, directors and officers liability, life, employee medical, dental and vision and automobile risks present a large potential liability. While we accrue for this liability based on historical experience, future claims may exceed claims we have incurred in the past. Should a different number of claims occur compared to what was estimated or the cost of the claims increase beyond what was anticipated, reserves recorded may not be sufficient and the accruals may need to be adjusted accordingly in future periods.

The company justifies its decision to self insure based on the fact that in the past it has not faced many substantial clams. This is no different than a homeowner rejecting insurance because his house has never burned down in the past. The entire purpose of insurance is to provide small payments which are known in advance and fixed in order to avoid unknown catastrophic losses later.

As with the pension errors and the substantial derivative speculation, the short sighted decision to boost the short term bottom line by virtue of self insuring does not seem to be a responsible one for any company which seeks to serve the best interests of long term and risk averse shareholders.

Conclusion

Shares of coffee related stocks have been strong performers over the past year, in part due to the falling prices for coffee beans which has helped to boost margins. In the past 12 months, shares of Starbucks are up 37%, while Green Mountain Coffee is up 74%. Small cap Farmer Brothers is roughly a double.

Enthusiasm for coffee related stocks has helped to boost Farmer Brothers despite the fact that it continues to lose money and despite the fact that much larger problems are quickly emerging.

Relative to other players in the coffee space, Farmer Brothers is a small company which has a limited following and limited research coverage. As a result, many of its substantial problems have gone largely unnoticed and the stock has simply been buoyed by strong sentiment for coffee stocks in general.

It is now the case that the true economic results for Farmer Brothers are more heavily impacted by the results of derivative speculation and pension obligations than by the actual business of selling coffee. But investors have missed these items because they are reported “below the line” of reported net income.

We have now seen meaningful resignations within the finance department and have seen the auditor replaced. This all happened along with a substantial restatement of the audit committee charter, which distanced itself from 3 years of inaccurate financials.

Members of the Farmer family have been able to exert substantial influence on the company despite little to no background in managing a public company. This becomes more concerning in light of the fact that the company is now facing much larger problems with growing derivatives losses and a pension obligation which is underfunded by at least $40 million.

The mistakes which occurred over the past 3 years were blessed by both management (the finance team) and by auditor E&Y. All of these parties are now gone and the going financials books will now be evaluated by new auditor Deloitte.

Given the history of problems and the increasingly complex situation at Farmer Brothers, there is a substantial risk that a stringent audit by a new auditor will reveal even larger problems for Farmer Brothers.

Farmer Brothers spent much of 2012 in the $7-8 range. This was before the ramp of in money losing derivative speculation, before the 3 year financial restatement and before the replacement of the auditor.

As these problems come to a head (and to the extent that they become a focus of new auditor Deloitte), Farmer Brothers should certainly be expected to return to levels of $7-8 or below. This would still value the company at well over $100 million.

Disclosure: I am short FARM, . I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

 

The big picture at Unilife (UNIS)

unis needle image

Investment considerations

As bulls and bears debate their longer term expectations for revenues at Unilife, many have missed the fact that there are near term catalysts which can be expected to have a very certain impact on the share price well before these longer term forecasts have a chance to play out.

Investors should also pay close attention to the stock promotion efforts which have accompanied the recent press releases and they should be aware of some nearly identical promotions in the past. As shown below, these types of stock promotions can often create more bounce in the share price than the actual news released by the company itself.

Separately, investors who wish to assess the longer term revenue prospects should make themselves aware of the current competitive environment. Many investors appear to have missed the existence of numerous competitors with similar product offerings who already have substantial cooperation from big pharma players.

As a final consideration, many investors have engaged in substantial debate over two negative articles which were published in Forbes in September. These articles contributed to significant volatility in the share price when they discussed a whistle blower lawsuit brought against Unilife by a former employee. Many investors appear to have never read the actual lawsuit and instead have simply relied upon the interpretation as represented by Forbes. Anyone with a longer term interest in Unilife should certainly read the suit themselves and come to their own interpretation. I have included as an Appendix a link to the full lawsuit text filing along with several text excerpts.

Section 1: Long term theses vs. near term catalysts

Last week was a volatile one for shareholders in Unilife (UNIS).

On Monday, the shares had traded as low as $4.03, closing at $4.15. But after the market closed, Unilife announced ”an agreement with Novartis to supply clinical products from one of its platforms of injectable drug delivery systems for use with one of Novartis’ targeted early-stage pipeline drugs”.

The mere mention of “an agreement with Novarits” had a predictable effect on the share price, and Unilife quickly traded as high as $5.25 in extended hours trading – an immediate gain of more than 25%.

These gains followed similar gains the previous week, following theannouncement of a long term supply agreement with Hikma Pharmaceuticals on November 20th. Just prior to this announcement, the stock had closed at $2.80.

After trading to as high as $5.25 in extended hours, the shares ended the week at $4.31, but had traded as low as $4.16 again on Friday. In other words, by the end of the week, Unilife had already given up almost all of its sharp gains following the Novartis release. The stock has already received price target upgrades from its three investment banks last week, but this appears to have provided very little support for the share price.

An outpouring of analysis on Wednesday added to the volatility in the share price, but appears to have not given much direction to the share price. In that one day, there were three large short articles and two large long articles published. These authors took turns repeating one another, contradicting one another and ignoring one another. All of this also happened to occur on the same exact day that CEO Alan Shortall was presenting at a conference in New York. Not surprisingly, the share price was very volatile that day, at times being down by 10% or up by 5%. It was equally unsurprising that the share price finally ended the volatile day almost entirely unchanged (up by just 2 cents).

The bull thesis is based on the opinion that this recent series of supply agreements will ultimately produce perhaps hundreds of millions in revenue from big pharma partners. However, even the bulls acknowledge that meaningful revenues are not expected to materialize until after several ramp up periods of as long as four years.

The bear thesis was fully detailed by Kerrisdale Capital which notes that recent announcements from Unilife are nearly identical to numerous announcements stretching back 10 years, each of which suggested that the onset of massive revenues was imminent. Such announcements had consistently caused the share price to soar dramatically, just as they have again done in the past two weeks. As they have been recently, analysts were then quick to upgrade the stock. Yet revenues for Unilife have continued to dwindle while Unilife has steadily issued nearly 40 million new shares in just the past few years.

For those looking to trade the stock, the inherent problem with both of these bull and bear theses is that both are predicated on how potential contracts and revenues will play out over a period of several years. Given the tremendous volatility in the stock recently, long term views may not be of ideal use.

Both sides are free to speculate on the longer term future of Unilife. However in the near term, one thing is quite certain: By the end of December, Unilife will likely be out of cash and the company is almost certain to issue a substantial amount of equity before the Christmas holiday. This is the near term catalyst.

Author Dr. Hugh Akston illustrated this catalyst quite clearly in a recent article. As of September 30th (i.e. two months ago, its last reported quarter), Unilife was down to just $7 million in cash. The company steadily burns around $3 million every month. The company did receive $5 million as an upfront payment from Sanofi in October, but Unilife has already disclosed that it plans on paying down a loan to Varilease for roughly that amount. As of right now, Unilife is therefore down to around $1 million in available cash vs. its consistent cash burn of around $3 million per month.

The incentive to conduct a very large equity offering is clearly substantial. Last week (following the sharp spike), Unilife had quickly risen by nearly 90% and was trading at its highest levels since 2011. But this is simply on a “nominal” share price level. In reality, the large number of shares which have been issued every year means that last week Unilife was closing in on its highest evervaluation (market cap) since coming public in the US. Some investors may not realize this given that the share price has fallen from above $10.00 to around $4.00 at present. Yet it remains the case that the market cap for Unilife had just hit within around 10% of its highest ever valuation since trading in the US.

The recent upgrades by Unilife’s investment banks were all based upon enthusiasm for the Novartis announcement. Yet these banks are not privy to any additional information beyond the press release, which we can all read equally well. The banks simply relied upon this simple press release to provide generous upgrades to their share price targets. Such jockeying for position ahead of a near term equity financing suggests that these banks are looking for an equity offering that will be bigger rather than smaller and which will provide millions of dollars in investment banking fees to whoever is selected by Unilife. Currying favor with the company by upgrading the stock should therefore have been fully expected. These upgrades have failed to support the stock, so it appears that the market has already come to this realization on its own.

Section 2: Evaluating the stock promotion efforts

When looking at the “big picture” at Unilife, investors need to understand that there is an active effort at stock promotion which has been going on for quite some time. The details from this particular effort are virtually identical to other stock promotions, some of which I have highlighted in past articles.

Here is how it typically works. (And readers should keep in mind that I am not specifically referring to Unilife in this description. I am referring to a cookie cutter process that can be seen very frequently across numerous micro cap reverse merger stock promotions)

In each case, the promotion involves a small, money losing reverse merger which supposedly has the potential for massive near term transformation along with billions in revenue potential. At some point, the company issues one or more press releases which happen to mention global mega giants within its industry. Specific terms which would allow for proper revenue forecasting are typically not disclosed for competitive reasons or due to “confidentiality”. The share price often moves to some extent based on these press releases. But much sharper gains appear when certain third party authors interpret these press releases for us and then issue massive multi bagger share price forecasts. Share prices can then often show additional gains of more than 50% in a very short period. But the gains are typically very short lived. Over time most of these promotion efforts end up giving up all of their gains, and in many cases they end of falling even further, for reasons that will be shown below.

On Friday, author Tech Guru weighed in once again to help us “parse” the debate on Unilife. He notes that he expects $50 million in revenue in 2014. By way of comparison, over the past 5 years, Unilife has generated a cumulative total of only around $25 million in revenues. But most of this came in 2010. More recently, revenues have dwindled to around $0.6 million per quarter. During this time span of several years, Unilife has repeatedly issued similar bullish forecasts which made statements such as:

we have been swamped with demand from a lot of other pharma companies who also have unmet needs.”

“We expect to be supplying this to many pharma companies in the near future,”Allan said.”

Past press releases dating back as far as 4 years include the following. (Note these are all PRIOR TO 2013, and as such should have already had an impact on revenues).

2010 - Unilife and sanofi-aventis Agree to Exclusivity List for Unifill(TM) Ready-to-Fill Syringe

2010 - Unilife and Stason Pharmaceuticals Sign Asian Distribution Agreement for the Unitract(TM) 1mL Safety Syringe

2011 - Unilife Signs Clinical Development and Supply Agreement with Global Pharmaceutical Company

2011 - Unilife Wins Supply Contract with Nation’s Largest Healthcare Alliance

2011 - Unilife Starts Unifill Syringe Sales to Another Pharmaceutical Customer

2011 - Unilife Commences Initial Supply of the Unifill® Syringe to Sanofi

2011 - Unilife on Schedule to Fill Initial Orders for Unifill Syringe

2012 - Unilife’s Bolus Injector Platform Targeted by Global Pharmaceutical Company for Use in Multi-Drug Program

2012 - Unilife Signs Long-Term Supply Contract for the Unifill Prefilled Syringe

In many cases, these press releases were just as exciting as the recent ones in 2013. They also consistently provided (very brief) boosts to the share price of Unilife as expected.

But the results have varied dramatically vs. expectations.

The points from these graphs demonstrate the following: the share price has been steadily declining for the past several years, even as Unilife has consistently issued millions of new shares. Likewise, revenues have dwindled by more than 70% while losses have grown substantially. All of this has occurred despite the consistent release of “news” from Unilife which has been largely similar to that which was released in the past few weeks.

It is therefore unclear how Tech Guru could be so optimistic regarding a tremedous surge in revenue next year.

A few months ago, I highlighted a different campaign by Tech Guru with Neonode Inc. (NEON), which appears to be nearly identical to the promotion of Unilife in virtually all respects. The similarities and parallels here should be patently obvious to anyone who has followed Unilife.

Tech Guru began writing on Neonode earlier in 2013. Between March and September, he wrote bullish articles on the company on average every 2-3 weeks. Neonode is engaged in licensing touch sensor technology, mostly to electronics OEMs.

Just like Unilife, money-losing microcap Neonode had put out several very promising press releases this year which could be linked to global giants within its industry. Over a period of months these included such heavy weights as Samsung and LG, along with automotive contracts with Volvo. Clearly this was going to be huge and transformational.

Just like Unilife, Neonode had been putting out nearly identical press releasesfor years, but consistently failed to generate meaningful revenues – despite the global giant partners. Just like Unilife, Neonode has never earned a profit in its numerous years in business. And just like Unilife, the press releases from Neonode were always kept vague and omitted the most relevant details, typically due to competitive or confidentiality reasons.

Given that multiple years of nearly identical press releases from Neonode failed to produce large scale revenues or any profits at all, it is unclear why Tech Guru would project that more identical press releases in 2013 would somehow lead to near term windfall profits and a skyrocketing share price. But by trumpeting names like LG and Samsung and predicting returns of more than 400%, his articles did cause the share price to briefly rise by around 60% to as high as $8.84 up from around $5.00 in March.

Just like with Unilife, the investment bankers were quick to upgrade Neonode based on nothing more than the very vague press releases. Investment bank Craig Hallum initiated coverage on Neonode when the stock price was just $3-4, and put a target of $7.50 on the stock, implying that they expected Neonode to double. The timing of this coverage was downright bizarre given that Neonode had just lost its largest customer, Amazon (AMZN), which had been responsible for 40% of its revenues at the time. But the upgrade worked and Neonode rose. By August, Neonode had still failed to replace its lost revenues and reported a notably large earnings miss which sent the stock plunging by more than 20%. What did Craig Hallum do ? They upgraded the stock again – now with a $10.00 target. This upgrade, along with more bullish articles by Tech Guru (predicting a $27 share price) sent the stock to just under $9.00. This sequence of events is all detailed clearly in my September article.

By now, this sequence of events should all feel very familiar to those who follow Unilife. So far they have been largely identical.

What happened next with Neonode was quite predictable. Neonode and its management sold $19 million in equity. Craig Hallum ran the deal (as expected) and made millions in fees. Meaningful revenues from the mega announcements may still be years away (if ever) and the stock price quickly fell by around 30% back to around $5.00 – right where it began. Prior to the offering, Tech Guru had been writing bullish articles on Neonode every 2-3 weeks for a 5 month period. This was a dedicated and persistent effort. But following the offering, the articles suddenly ceased for several months.

Many investors may wonder if such promotions can actually have a meaningful impact on the share price. The answer is a categorical “yes, they can”, especially if executed by a professional. This point can be made clear with a separate example.

Lately the Novartis news has taken center stage to the point where many investors have stopped focusing on the recent Hikma news from November 20th. The Hikma announcement caused Unilife to soar by more than 30% to $4.03. But after the initial surge, investors began a meaningful sell-off as they fully evaluated the news. It was only a double promotion from a paid subscription service called “The Focused Stock Trader” that sent Unilife soaring.

The graph below illustrates the sequence of events.

- Nov19 / 20 – Unilife announces Novartis news – stock rises to $4.03

- Nov21 – UNIS stock immediately trades down as low as $3.63 (down 9.9%) closes at $3.73

- Nov22 – 25 – UNIS struggles to hold above $4.00

- Nov26 – TFST promo article to paid subscribers only - UNIS immediately jumps from $3.85 to as high as $4.38 (13% jump and a new 52 week high).

- Nov27th – TFST article released on SA at 2:35 pm – stock jumps again from below $4.20 to as high as $4.50 (breaking yet another 52 week high)

- Nov28th – Thanksgiving – market closed

- Nov29th – Friday – stock closes at $4.40

- Dec 2nd – Stock closes at $4.15 (down 6%) hitting a low of $4.03 again (right where it began)

- Dec 2nd (after market close) – Novartis news released

The conclusion from this is that the stock had been quickly falling below $4.00 until it was pumped up by TFST and his distribution to his subscriber and then the follow through on Seeking Alpha. The stock was quickly losing momentum again, and the only thing the resurrected it was a new press release regarding Novartis.

TFST is a paid stock promotion letter. According to its results page, TFST is among the best investors in the entire stock market throughout the history of time eternal. Better than Buffet, Ichan or Soros by a long stretch. It notes that:

As our results show, The Focused Stock Trader recommendations were correct 52 out of 55 trades for an average return of 29.69% per trade with 2 trades generating returns in excess of 200%. The average holding period for our recommended trades, not including open trades, is 24 days. THE FOCUS STOCK TRADER HAS BEEN CORRECT 95% OF THE TIME GENERATING 30% EVERY 24 DAYS.

Apparently by following TFST, one can quickly become immensely wealthy. Fortunately, TFST makes its expertise available to the public, for anyone willing to pay $400 per quarter ($133 per month) or $1,200 per year ($100 per month). Based on this, it is very easy for TFST to pull in a 6 figure income from subscription revenue irrespective of the performance of any trades it recommends.

closer look at TFST reveals that many of these stock picks end up being for very speculative reverse mergers which demonstrate great volatility. The research underlying them is often questionable, yet TFST has apparently generated significant returns on the upside, quickly selling before these stocks fall back to Earth.

For example, back in August, TFST highlighted Organovo Holdings (ONVO). Histrack record notes that he had sold the stock for prices as high as $11.20. But when the stock was trading at over $12.00, I highlighted the fact that much of its gains were due to misinformation and inaccurate comparisons to 3D printing stocks such as 3D Systems (DDD) and Stratysys (SSYS). The article from TFST contains the exact type of misinformation that I had referred to. He noted that

Needless to say, Organovo can do for 3-D printing what Microsoft (MSFT) did for PCs and Ford (F) did for the automobile; make a long-sought after dream a reality.

Shortly after TFST was selling at $11.20, the stock quickly ended up falling below $8.00. The stock has recently jumped due to the CEO’s presentation at retailinvestorconference.com. But even on that conference, the CEO went out of his way to make clear that Organovo is NOT a 3D printing stock.

TFST clearly benefited from the rise in the Organovo even though its research was largely unfounded. So, what’s the harm ?

The harm is that when stock promoters put out unfounded research on tiny, speculative reverse mergers, investors end up buying into these stocks without understanding that there are very substantial risks. TFST’s next pick was Fab Universal (FU), which he ended up making a whopping 99% on, selling it at $10.75. Congratulations to TFST, however that stock has since been halted after a fraud expose by GeoInvesting. Prior to the halt, this stock had last traded at $3.07. Trading has not yet resumed. Anyone who has been stuck holding a Chinese microcap which has been halted due to fraud allegations would likely not hold much optimism for the future of Fab. TFST was smart enough to get out at $10.75, but its subscribers may not have been so lucky. On its website TFST notes that:

In our reporting, we will suggest the purchase point; however, it is up to you to decide when to close out the position.

Likewise, on Unilife, we will have no idea how quickly TFST will end up running for the exits. In fact, it may well be the case that TFST will have the benefit of selling to individuals who are still buying based on research provided by TFST. That advantage, along with over $100,000 per year in subscriber income, makes for a great business model for TFST.

A longer look at the TFST track record shows a predisposition towards speculative and volatile reverse merger stocks which often end up in the cross hairs of short sellers. Revolution Lighting (RVLT) which TFST was selling as high as $5.00 was later exposed by a short selling and fraud focused site the StreetSweeper. The stock subsequently fell by as much as 50% from where TFST was selling, and it now sits at around $2.80. But it appears to have been another great trade for TFST who got out early. Likewise, it is very difficult to understand how anyone could have ever recommended beleaguered OCZ Technology (OCZ) which has been on terminal status for over a year.

TFST had noted that :

Short sellers are still holding on, but perhaps not for long. OCZ’s short position is at an unsustainable 79.3%.

Within a month, the shares had already plunged by around 80%. Since that time the shares have fallen by more than 95% and now trade for around 10 cents. It looks like there was a reason why the short interest was so monumental.

Yet OCZ has continued to be a promo pump target even now. Ashraf Eassa recently warned that there is still a pump campaign trying to spread rumor of a buyout on this now dead stock.

In separate disclosure on November 29th, TFST noted that his holding periodwas as short as just 14 days. The point is that small reverse mergers can often pop due to the sensation which surrounds vague press releases. This is especially true when the press releases include the names of major, global industry players. As players such as TFST have demonstrated, the best way to profit from such hype is to buy the rumor and (very quickly) sell the news.

The promoters behind Unilife have demonstrated a consistent tendency to back speculative, money losing reverse merger stocks. As with TFST, other backers have found themselves on the opposite side from short sellers.

Tech Guru had previously penned an article to rebut the short thesis on Coronado Biosciences (CNDO). Coronado had the implausible idea of making medical treatments out worm eggs which grow on pig feces. Tech Guru sought to debunk the short thesis which had been highlighted again by such skeptics as the StreetSweeper.

In its “public oath” the StreetSweeper states that:

We aim to partner with the public in exposing corporate fraud and bringing its engineers to justice. To that end, we pledge to investigate credible allegations of misconduct and – if the evidence supports those accusations – report the truth about our findings. At the same time, we agree to disclose any conflicts that could potentially color our judgment. By embracing these core principles, we hope to protect ordinary Americans and deliver them news that they can trust.

Readers can take that “public oath” with whatever grain of salt that they like. The point from it is that sites such as the StreetSweeper do not focus on stocks which are merely overvalued by 10-20% or which might have a bad earnigs quarter. They are focused on catalysts which are far more dramatic and which imply far larger share price moves.

As with Unilife, the shorts made their case by saying citing a horrible track record by management, including huge share sales despite no revenues. In backing this company, Tech Guru was defending the indefensible. As should have been expected, the use of worm eggs from pig feces failed in clinical trials and the share price plunged from over $8.00 to as low as $1.25. Yet the elevated share price before the failure allowed management to raise over $200 million from stock sales over the past few years. The shorts were particularly focused on the fact that a small group of insiders had been repeatedly involved in similar speculative ventures which soared on the hype but which imploded following large share sales. Since the implosion of Coronado, Tech Guru has ceased providing further updates on the company.

The point from these examples is that generating excitement around tiny reverse mergers which generate little to no revenue is far easier than generating excitement around larger companies which are profitable and stable. This is precisely why promoters choose such companies. Yet by ignoring or denying the warning signs highlighted by the skeptics, these promoters can often encourage other investors to invest in stocks which have very significant (and unknown) downside potential.

Other Unilife bulls appear to be engaged in a different strategy when writing about Unilife.

In the past year, Fusion Research has gone from zero articles on Seeking Alpha to almost 400. A new article appears from them on almost every trading day, with the result that Fusion is now #1 on long ideas, #1 on services stocks and #1 on industrial goods. These rankings are based purely on number of hits.

Fusion describes itself saying:

Fusion Research is managed by a team that has been actively involved in the financial research industry for over 5 years. Our business is rooted in principles of trust, integrity and fundamentals-driven markets.

But it also notes that

We create strategic partnerships with companies and firms to gain unprecedented domestic and international following of our coverage.

In fact, a closer look at Fusion’s own website reveals that Fusion is actually an IT outsourcing firm which focuses on simple web development and HTML. There is a link where once can “learn more” about its investment research activities. But that link is broken and leads to nowhere.

In its almost 400 articles, Fusion has consistently written about mega cap stocks which have a huge built in following of thousands of readers. But it has also made it a point to write about smaller stocks which have recently shown dramatic price moves and which will also automatically generate a large number of hits.

The key point is as follows: During a two week period, shares of Unilife soared by as much as 88% on the back of two press releases which are encouraging but still far too vague for planning or forecasting purposes. Prior to this, the shares closed at $2.80 and the shares have already begun a substantial retreat.

The attention of promotional authors can often have an even larger impact than the news from the company itself. While this can often create great short term trading opportunities for those who are nimble, holding these stocks after they peak can end up producing substantial losses on the way down. Investors should be aware that those who promote such stocks often have zero intention of holding the shares and often intend to play it as a quick “buy on the rumor trade”. Other authors are simply attracted to the most volatile stocks which tend to generate the largest number of page views and typically do not even buy the stocks they are writing about.

Section 3: Competitive considerations for Unilife

Many of the recent articles have been overwhelmingly focused on highlighting the dramatic upside associated with Unilife, while downplaying the substantial risks of buying on this spike. They have also ignored the competition.

There is a reason why promotional authors tend to ignore the risks and competition: it works.

We can very easily see what happens when an author pays even moderate attention to risk elements after a stock has already spiked. Once the stock has spiked, any attention to risk can send it sharply lower.

On December 2nd, Dr. Thomas Carr wrote a very bullish article on Unilife entitled “Unilife: Set To Double In 2014?“. In his opening pitch, he notes that he is long the stock and that:

As it turns out, demand for Unilife’s unique medical dispensing technology is so strong and growing so fast that shares of the company may well be one of 2014′s best investments in the healthcare sector.

What was the result of this strong enthusiasm from one who identifies himself as a “doctor” ? The stock actually fell 7% that day. There are two reasons for this.

Despite his own personal bullishness and disclosing a long position in the stock, Dr. Carr was forthright enough to at least mention the substantial downside that comes along with Unilife. He noted that:

New and current investors should keep in mind the risks outlined above. The company may well be covering up past fraudulent activity. The Biodel deal may well fall through. Management may continue its unfortunate streak of over-selling its EPS potential.

But of much greater importance was the fact that Dr. Carr was among the first to pay more than passive lip service to the existence of substantial competition within this market.

Even Unilife itself discloses that there is meaningful competition in this space. But the mostly retail investor base in Unilife often seems to feel that Unilife is inventing a new product and will quickly command a monopoly in the space.

In its most recent 10K filing, Unilife discloses its view on the competition which already consists of some of the largest and best financed giants in the healthcare industry, saying:

We are aware of five companies which specialize in the production and supply of glass ready-to-fill syringes. These companies are BD, Gerresheimer, MGlas AG, Schott and Nuova Ompi. We estimate the market concentration rate for these five companies to be approximately 95%. We believe BD’s market share to be in excess of 50%, as it has supply relationships with most pharmaceutical companies and contract manufacturing organizations.

The point that investors need to realize is that this is not a soon-to-be-created new market which will be dominated by Unilife. It is already an established and highly competitive market.

In September, the big news for Unilife was the Sanofi contract which may eventually lead to meaningful sales of Lovenox in prefilled syringes. But in its September conference call, Unilife noted that

the IMS data for Lovenox for 2012 shows the sale of over 450 million prefilled syringes with Lovenox in it.

The point is that there are already hundreds of millions of units of being provided by competitors on the market two years before Unilife even plans on entering the picture in 2014. Many investors have been entirely unaware of this competitive reality and have assumed that Unilife is about to create a multi billion dollar monopoly.

Dr. Carr briefly listed a number of Unilife’s competitors within the space who have existing or pending product offerings which will largely compete within the same space.

In addition to Beckton Dickinson (BD), Gerresheimer, MGlas AG, Schott and Nuova Ompi (which were mentioned by Unilife), Dr. Carr also mentions such giants as Amgen (AMGN), Pfizer (PFE) and West Pharmaceuticals (WST). Medical giant Baxter International (BAX) is also active in prefilled syrniges. Baxter is valued at $37 billion based on annual sales of over $14 billion.

The point is that breaking in to this space will be difficult, even despite several encouraging potential supply contracts. The competition in this space is well established and extremely well financed and will have the ability to compete aggressively on volume, quality and price.

Conclusion

The market has now had the opportunity to digest in full the recent news from Unilife along with the ample analysis from third party authors. CEO Alan Shortall has had the opportunity to speak to investors in New York and the sell side analysts have already had their chance to upgrade the stock.

With all of these events now being mostly digested, the stock appears to be once again giving up its recent gains rather than continuing to surge higher.

The market may well be already pricing in an equity offering due to the realization that Unilife will likely be out of cash before Christmas.

Much of the sharp rises in the stock can be tied to recent promotional articles by authors who tend to focus on short term trades in speculative reverse merger stocks. In the past, some of these efforts have sensationalized press releases from other micro cap reverse mergers and have predicted a surge in near term revenues and multi bagger share price returns. This is an easy task when the press release includes the names of global giant heavy weights.

But when similar such press releases have been consistently issued for years without meaningful resulting revenues, investors should likely ask themselves how the latest series of press releases will create a result that is in any way different.

There is already existing competition in the specialty syringe space, with hundreds of millions of units being delivered even just for individual drugs such as Lovenox. Those who have been under the impression that Unilife has created a novel product and will soon be commanding a monopoly would do well to expand their research into the substantial competition in the specialty syringe space.

Appendix I – details of Unilife lawsuit

For those who wish to read the details of the Unilife lawsuit in their entirety, updating filings from August can be found at the following link at my website atmoxreports.com. Readers can also sign up for email alerts. There is no charge for this and email addresses are not shared with anyone. Ever.

Readers should also be aware that Unilife has already responded to the article on Forbes. A link to that response can be found here. However, readers should also note that there are a number of items in the actual whistle blower lawsuit which do not yet appear to have been responded to by management.

The lawsuit was brought by Talbot Smith, formerly an executive at Unilife who was hired in 2011. The suit notes that Smith was a Stanford graduate with a BS in Industrial Engineering and an MS in Operations Research. His starting salary was $230,000 plus various incentives including bonuses and stock options.

The gist of this lawsuit can be seen on the first page of the filing. The cited “causes of action” are a) violations of Sarbanes Oxley and b) violations of the Dodd-Frank Act.

Sarbanes Oxley (or “SOX”) was passed in 2002 in direct response to various accounting scandals including Enron, Tyco and Worldcom. SOX requires that top management certify the accuracy of SEC filings and dramatically increased the penalties for fraudulent activity.

Dodd Frank was passed into Federal Law in 2010 in response to the financial crisis which began in 2008 and also was designed to incorporate enhanced protections for investors.

As noted, the lawsuit was originally filed and received by the US Department of Labor/OSHA. The lawsuit notes that the Secretary of Labor did not make a final determination within the 180 day deadline, but that “sufficient prima facie evidence was found to begin an investigation” (page 2). As a result, the case was moved to Federal Court.

This filing is very long because it also incorporates original copies of the press releases and the 10K filing which are said to contain the inaccurate statements.

Some of the claims by Smith state that products being supplied by Unilife were not “validated” (as had been claimed by Unilife) because the FDA required activities had not been completed at the time that these statements were made to investors. Unilife subsequently brought in FDA auditors who stated that by the time of the audit, the validation could be considered complete.

These FDA claims will therefore be very difficult for either side to verify. The argument Talbot would make is that compliance would have been achieved well after he reported his observations to the FDA, but prior to the audit. The argument from Unilife is simply that this is not true.

Other claims should be less ambiguous. For example, on page 7, we can see Smith’s claim that the previous 10K filing made inaccurate statements to investors regarding shipments of “commercial” product by Unilife. Talbot backs this statement by noting that “no revenue had been collected from commercial sales of the Unifill product”. Ultimately, an audit by the SEC will be able to trace documentation of this claim and make a determination. This should be black and white.

Likewise, Talbot claims Unilife made false statements about its production lines. Talbot claims that at the time of the statements, two of the production lines were actually still in Denver, Colorado, and certainly not installed. Again, this should be a very black and white matter to resolve in an investigation.

In general, I am far less focused on the FDA issues because I believe that they will be far more difficult for either side to resolve. But on Page 11, the lawsuit describes additional product quality failures which had supposedly been reported by Smith via email. The lawsuit then notes that

The following day, Mojdeh told Smith to come into his office. Mojdeh instructed Smith that he should not put any concerns into emails because they could be used against the company in future legal action

Once again, an investigation will certainly dig up any emails prior to this conversation. Either the emails referred to by Smith exist or they do not, so there should be a conclusive result to an investigation by the SEC.

Other claims may be easy to document, even though actual “intent” may be hard to prove. On page 11, the lawsuit notes that:

Unilife also took actions to mislead investors about its customer demand and manufacturing capacity. To this end, Mojdeh directed Smith to have his team purchase 1,000,000 units of Unifill components per month in spite of the fact that there was no customer demand or manufacturing capacity to justify this level of purchasing. Mojdeh told Smith that the objective of the purchases was to make suppliers believe that Unilife was manufacturing at this volume, with the hope that the information would leak to the financial markets.

The point here is that proving that Unilife made unnecessary purchases at huge volume should be relatively straight forward. And this could easily be explained by the ballooning losses and dwindling revenues seen over the past 3 years. Yet actually proving the intent of Mr. Mojdeh will likely be a more difficult endeavor in an investigation or a courtroom.

On page 12, the lawsuit states that:

Another action that Unilife took to mislead investors was to run fake production when investors or customers were visiting the facility. On more than one occasion, scrap was run through the machines to make it appear that Unilife was making product when it was not. Product was placed on skids by the warehouse doors to give the false appearance that product was being packaged and send to customers when it was not.

Presumably the only way to get much resolution will be when the SEC subpoenas the warehouse workers who either did or did not perform these activities. The truth should be easy to get at because warehouse workers typically do not have a large financial inventive to bend the truth when faced with the potential for perjury charges. In addition, there are likely a large number of warehouse workers. Keeping a secret gets harder as the number of individuals increases.

On Page 13, the lawsuit notes that

Shortall made comments that were posted on the Yahoo! Finance message board on July 10th, 2012, indicating that Unitract was profitable with a 20% gross margin, when Unilife was in fact losing $1.00 per unit.

Again, this will be an easy one to either prove or disprove.

Conclusions regarding Unilife lawsuit

The details spelled out in the lawsuit vary between crystal clear and verifiable to murky and difficult-to-prove. Some investors may be inclined to wonder why we have not already seen some resolution to these matters given that they relate to issues dating back to 2011. Other investors may be inclined to feel that if we haven’t seen consequences yet, then there may simply be nothing to worry about.

In general, SEC investigations take considerable time and there are no “hints” along the way which would given guidance as to the eventual conclusion. For example, in October 2013 the SEC was just providing final resolution to the fraud case at YuHe International, which has been ongoing since 2011. China frauds were a big focus in 2011, and in October 2013 the SEC finally got around to issuing final judgment against China Media Express (“CCME”), also following fraud that was uncovered in 2011. The point is that these things can often take a few years before visible results are uncovered. No one should expect that there would have already been an immediate result just because these findings were made public over a year ago.

Disclosure: I am short UNISONVO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

Organovo set to fall by 50%

liver

Investment overview

Shares of Organovo Holdings (ONVO) have recently skyrocketed due to widespread media coverage and an equally widespread misunderstanding of the company’s near term revenue potential. The stock has risen from $2.00 to over $13.00 in the past 12 months and is now valued at over $1 billion. To date Organovo has generated no real commercial revenues, but has brought in small amounts of money from grants and collaborations. The company hopes to launch its first commercial product, a 3D liver assay, in December of 2014, 13 months from now. A launch of any possible next products has not been announced or discussed, but would likely take several more years for any visibility. So for now, this one product is all that there is to hope for for the next few years.

In July, Organovo conducted an equity offering at $4.50 per share. As a result, the company now has a cash balance of approx. 58 cents per share. Aside from the recently raised cash balance, the sum total of all of Organovo’s other assets is just $1 million.

On October 22nd, Organovo Holdings announced that it had presented data demonstrating retention of key liver functions in bio printed tissues for up to 40 days. In response to this, the share price rose modestly from around $6.50 to as high as $7.50 before retreating back below $7.00 once again. The news was out and the stock remained flat for around two weeks. This is clearly not what caused the stock to soar recently.

Starting on November 6th, about two weeks after the announcement, the stock began to take off. Most of this was due to a rapid fire series of bullish articles on the Motley Fool and Seeking Alpha which often came out on nearly every other trading day since the announcement. Many authors and investors have suggested that Organovo may be on the verge of a massive revenue opportunity of tens or even hundreds of millions of dollars in the near term.

During this brief time, the share price has nearly doubled, hitting a new lifetime high of $13.65. The company has nearly 90 million shares fully diluted such that it has now exceeded $1 billion in market cap. It should be noted that there has been no other news whatsoever from the company, only from bullish authors. Readers should also make note of the tremendous surge in volume which has occurred on no substantial news. The point here is that this spike was not driven in any way by the only significant announcement made by Organovo back in October.

Authors who suggest that Organovo is set to begin pulling in tens or hundreds of millions of dollars from sales of liver toxicology assays starting in December 2014 clearly do not understand this product or the market for it.

By now it is well known that drug companies risk losing billions of dollars when one of their drugs enters and then fails clinical trials. Liver toxicity is one of the most common reasons for a drug to fail. As a result, many of these authors have simply created a leap of logic that if the drug companies stand to lose billions, then Organovo must stand to make a fortune by introducing another diagnostic test for them. This isn’t how it works at all.

It is clearly the case that much of the overwhelmingly retail shareholder base simply does not understand the market for 3D liver toxicology assays. What they clearly don’t realize is that there are already competing 3D liver assays on the market right now, and sold in the US, which sell for as little as $1,750 per 96 well tray. Yes, these are 3D bio printed liver toxicology assays, which serve the same function as what Organovo hopes to offer. But Organovo won’t even begin for at least another 13 months from now. Retail investors are not aware of competing 3D bio printing companies because many of these companies are not public companies and / or are not US companies. Multiple examples of competing companies in the 3D bio printing space are shown below. Yet because they are not public they have not enjoyed almost daily bullish articles from places such as the Motley Fool.

It is clearly shown below that Organovo’s total revenue potential from 3D liver assays for Organovo amounts to just $3-5 million cumulatively from 2014 through all of 2016. This is because the total market size for 3D liver assays is limited to a few thousand units at most. By 2020, other product offerings (such as kidney assays) may eventually emerge, but so far there is still nothing definitive from the company at all. It should be kept in mind that Organovo has possessed its current technology since 2009, and developing this first product has taken 5 years. So investors should understand that the wait time until we see second product may also be a few more years.

Some of the confusion likely stems from the Organovo presentation which cites a $500 million market opportunity for cell assay products by $2018. The data came from “Scientia Advisors”. Investors need to understand two things. First, this market opportunity applies to an extremely wide variety of assays to be used across the market for a wide variety of uses. It will also be served by many competitors, not just by Organovo. Right now Organovo has in development just a single assay product to fit into this entire market, such that the size of the overall market has very little to do with Organovo’s financials over the next 5 years. Second, investors should be aware that the Scientia data was part of a “sponsored” study in which Organovo hired and paid the firm to produce these estimates

It should also be kept in mind that any revenue in the near term assumes that Organovo is successful in developing the product and that it is launched on time in December of 2014. Investors still bear the risk that the product either doesn’t work as well as planned or is delayed beyond December 2014. For now, we can give Organovo the benefit of the doubt and assume the best for this project. But investors must absolutely realize that the very best case, assuming success, is for a just few million in revenues (NOT a few hundred million). This will be clearly demonstrated below.

Just two weeks ago, prior to a surge in high publicity articles, the stock was sitting flat below $7.00. As the share price has risen due to over a dozen recent articles, management has been selling hundreds of thousands of shares in October and November and has filed a massive S8 registration statement by which they can now issue to themselves over 11 million new shares. This represents nearly 13% of the company in new shares, and would be valued at over $130 million, just for the personal benefit of a small group of insiders.

 

As should likely be expected, these insider sales and the large S8 equity registration statement escaped the attention of many investors because they have been consistently filed by Organovo management with the SEC on Fridays, and notably after the market was closed. As anyone would expect from this, most investors were quite obviously not even looking at their screen on a Friday at 5 pm. The most recent set of management stock sales came again last week. The SEC filings were released again on Friday. And again it was well after market hours when no one was looking. Links to these filings have been included.

As investors come to realize that Organovo currently has only a few million dollars in cumulative revenue potential over the next 3-5 years, it becomes very difficult to justify the lofty $1 billion valuation. These realistic revenue numbers are a dramatic variance from investors’ mistaken expectations of hundreds of millions of dollars. The biggest near term catalyst for a sharp decline is the ongoing insider sales the huge equity registration by management and the sudden realization that revenue potential is minimal.

Investors should therefore expect the share price to quickly return to below $7.00, where it was prior to over a dozen promotional articles on Organovo released in the past few weeks. As recently as November 5th, Organovo had traded as low as $6.61.

Important Note: The market data with respect to pricing and volumes of 3D liver assays should be seen as highly verifiable. This is how investors should estimate future revenue prospects. Links are included so that they can be verified by anyone. For investors who wish to conduct their own checks, I strongly encourage them to ask Organovo management directly about expected prices and volumes. Management can be reached at IR@organovo.com. Alternatively, investors can ask other 3rd party sources such as Zacks analyst Jason Napodano who has covered the stock or companies such as Insphero (shown below) which already sell 3D bio printed liver assays. These sources will yield estimates that should all be very much in line with the ones I present below.

Background information

Organovo is a stock which lends itself to significant misunderstandings by the market. It also lends itself to over promotion and manipulation. Despite all of the mainstream enthusiasm for 3D printing and bio printing, Organovo has just7% institutional holdings - 93% of the stock is held in retail hands. Stocks such as 3D Systems (DDD) are held in the majority by institutions.

Organovo has just one analyst who has covered it, Jason Napodano from Zacks. However, Mr. Napodano has recently dropped coverage of Organovo due to the valuation. On the Twitter page for TheStreet.com’s Adam Feurstein, a series of tweets and retweets between Feuerstein and Napodano now suggests that “At this price, I think $ONVO could be as much as 500% over-valued.”

When a stock is only owned by retail investors and there is limited research coverage, it is very easy for the stock price to be heavily influenced by articles in the media. This is especially true when the articles come in rapid succession almost every day. Of course, investors need to be aware that many of these very bullish articles come from those who happen to own the stock and would like to see it go up.

In arriving at my revenue projections, I conducted simple market analysis and identified competing 3D liver assays which are already being sold on the market. The price for these 3D liver assays is readily obtainable. It is also easy to estimate the number of units that might be sold in a year. According to clinicaltrials.gov, there are around 500 new drugs which enter phase 1 testing each year. Organovo might hope to gain a significant share of these. They might also hope to gain a share of roughly 1,000-2,000 other compounds that could be tested each year. Each 3D liver assay tray contains 96 wells which can be used to conduct independent tests. As a result, for any given drug, a single tray should be more than ample. Based on this, if Organovo was extremely successful and immediately captured significant market share, it might end up selling as many as 1,000 total units of these 3D liver assays in a year. As a result, we come up with a number of roughly $2 million per year in revenue to Organovo. But this is beginning in 2015 after the product is launched in December of 2014. For the year 2014, investors should remember that product revenue should be close to zero.

That is a very simple method of market analysis that helps us approximate total revenues for Organovo. It is not going to be precise down to the dollar, but it shows clearly shows the following:

There is precisely zero chance of Organovo reaping hundreds (or even tens) of millions of dollars in revenues over the next 3-5 years. Organovo management certainly can have no such expectations. Only the retail investors do as a result of a recent string of bullish articles. Even if an investor wants to arbitrarily double all of the assumptions above, it does not even come to $10 million cumulative revenues for the next 3 years total. Beyond 3 years, we have been given no indication when additional products will be launched.

In arriving at my unit calculations, I first used clinicaltrials.org. I then cross checked my numbers with those which had been prepared by Zacks, who had consulted directly with Organovo management when making their revenue estimates. As a final check, I spoke directly with Swiss company Insphero which already sells these 3D bio printed liver assays for drug toxicology. The results are all quite consistent at a maximum of a few thousand units per year for the total market size. Insphero is the company that sells these 3D bio printed liver toxicology assays for $1,750. More details are included below.

The market for 3D liver assays is simply not a large one, the prices are not very high, and there are already other competitive products actively selling in the market. Those who have projected hundreds of millions in sales have simply failed to look at the market for this product. Instead they simply (and falsely) assume that any product being sold to big pharma must automatically generate hundreds of millions of dollars.

It should come as no coincidence that my estimates above are very closely in line with the estimates of Zack’s research in their detailed initiation report on the company. On Page 16 of the report Zack’s shows clearly that the company is expected to generate revenues of $0.5 million in 2014 and then $2.0 million in 2015, going to as high as $4 million for all of 2016. Zack’s used a different method than I did in arriving at these estimates: they interacted directly with management in putting revenue estimates together.

 

I contacted Zack’s analyst Jason Napodano a few days ago to see if these revenue estimates were still valid or if anything had changed. He noted that his revenue estimates are still valid for upcoming years. Nothing has changed. Mr. Napodano has written on Organovo on multiple occasions and has been consistently positive on the company and on their technology and prospects. But because he has a much clearer picture of the realistic revenue potential over the next 3-5 years, he last maintained a $5.00 share price target for the share price. His last coverage was updated just 12 weeks ago.

 

But now we can see from the Zacks’s website that the company is no longer providing updates on Organovo. When I wrote to Mr. Napodano about this, he stated “I dropped coverage given the exorbitantly high valuation. Can no longer recommend people own it.”

A price between $5.00 and $7.00 is certainly where Organovo should be expected to trade in the near term. This is where it was just 2-3 weeks ago. This is well below the current levels and certainly below the lofty levels expected by those who have inaccurately suggested hundreds of millions in revenue.

We can contrast the market research approach to numerous other articles which have appeared in the press in recent weeks. On Friday, one Seeking Alpha author applied simple random guesswork in trying to calculate revenue potential stating:

We don’t how long it will take ONVO to reach $100 mill. to $200 mill. revenue, that might better support current prices, as there is not enough guidance from the company to make those projections. But a reasonable guess of going from $0 to $100 or $200 would be at least three years, which would put is in the FY 2017-18 timeframe as being the earliest when we would expect annual revenues to reach that level.

In fact, there are actually plenty of data points to help quantify just how much revenue Organovo can expect from its only product (3D liver assays) over the next 3-5 years.

This author demonstrated no research into the market and simply stated that by 2018 Organovo might be raking in as much as $200 million. This is a staggering amount of revenue and is in no way supported by anything that Organovo currently has in the works or has even envisioned in the near future.

(Perhaps by coincidence, when this article was released trading 3 days ago, CEO Keith Murphy filed to note that he had just sold another 100,000 shares. His filing to notify investors came after the close of the market on a Friday, so many investors might be expected to have missed this.)

Similar revenue projections in multiple other articles are the sole reason why the share price has doubled in the space of two weeks to its current billion dollar valuation. They have truly lit a fire under retail investors which then sparked momentum traders to pile in. But these types of projections for the next 3-5 years are entirely without foundation. They are wrong. When the momentum traders take the reverse direction on the stock, a significant correction should be expected. Momentum traders by definition do not even care what a company does. They only care about the near term direction of the stock. Momentum traders tend to pile in in force and amplify movements to the upside as well as to the downside. Yet they are “direction agnostic” and are just as happy to profit from a stock on the way down.

Over a ten year time frame, Organovo can be expected to attempt to develop other revenue streams such as assays based on other organs like the kidney. But these are years away and we do not have any visibility on when they might be launched. Organovo has possessed its current technology since 2009 and the first commercial product, the liver assay, will not be launched until 5 years after that time. In the more distant future, the real excitement for the company is the potential to develop fully functioning replacement organs for transplants. But this is even further away and has no impact on the current share price.

At present, the reality for all investors is that Organovo is only capable of producing liver tissues that are just 1 millimeter thick and which can be sold in trays for less than $2,000. Even this will not become a reality for another 13 months, and then only if all goes as planned. The notion that Organovo will reap hundreds of millions in revenues at any time in the foreseeable future is pure fiction.

There is already significant competition in the 3D bio printing space

Organovo is the only publicly traded company that is solely focused on 3D bio printing. This has led many investors to believe that it is the only company engaged in this business at all. This is completely mistaken.

Below I will list a quick 7 notably obvious direct and indirect competitors within the 3D bio printing space. Like Organovo, these companies are all involved in the printing of cell matter such as organ tissues using 3D bio printing technology. But readers should note that beyond these 7, there are many, many more for those who care to search around. As with Organovo, many of these companies have their roots within some of the worlds most prestigious universities and research institutes. (Organovo’s origins came from theUniversityofMissouri). These various competitors are active in theUS, Europe and inChina. Some of them are already are commercializing products well ahead of Organovo.

For example Swiss company Insphero sells 3D liver assays for drug toxicology and has partnered Cyprotex. A spin-off company of the Swiss Federal Institute of Technology (ETH) Zurich and the University Zurich, InSphero was founded in 2009 by Dr. Jan Lichtenberg, Dr. Jens M. Kelm and Dr. Wolfgang Moritz. On the Insphero website, these are very clearly marked as liver assays for toxicologyand they are very clearly marked as 3D bio printed products. These serve the identical purpose that Organovo hopes to serve 13 months from now. But for Insphero they are already on the market. The price comes in at just around $1,750 for each 96 well tray. Different tests can be run independently in each well, such that one tray is sufficient for 96 different outcomes. This means that one tray should be largely adequate to get test results for a single drug. Product inquiries forUS sales can be direct to sales@insphero.com or via theirUS sales number at +1 207 751-4908.

 

Insphero describes its current operations as shown below. This should look familiar to Organovo investors, except that Insphero has already been selling its product since 2012.

 

InSphero is a leading supplier of organotypic, biological in vitro 3D microtissues for highly predictive drug testing. The company, headquartered in Zurich, Switzerland, currently counts 7 of the top ten global pharmaceutical and cosmetics companies as customers. InSphero 3D Insight™ Microtissues enable more biologically relevant in vitro applications in efficacy and toxicology.

I did call Insphero directly and spoke to a sales representative who confirmed that the market for these 3D liver assays (which have been on the market for over a year) is only in the thousands of units total. The sales rep noted that in a large spike before the upcoming holiday season, the company actually shipped nearly 100 units in a week, which was extremely large. I also confirmed that the primary use of these tests (as with Organovo) is for drug toxicology testing by pharma companies.

Here is a screenshot from their website.

 

Yet another competitor is the Wake Forest Institute for Regenerative Medicine, run by Dr. Tony Atala. Their business should sound very familiar to those who follow Organovo. As noted in livescience.com.

 

Atala’s group has pioneered 3D printing methods that aim to build human organs with layer upon layer of cells. Their bioprinting methods lay down the cell layers along with artificial scaffolding to keep an organ’s structure intact as it takes shape – a technique that has allowed the group to make tiny, less complex versions of full-size human organs. “We’re printing miniature solid organs: miniature livers, hearts, lungs and vascular structures (blood vessels),” Atala told LiveScience.

WakeForestis far enough along in its development of that it has already been selected by the DoD to lead the following programs, as noted.

The Wake Forest Institute for Regenerative Medicine is leading the $24-million effort funded by the Space andNavalWarfareSystemsCenter, Pacific (SSC Pacific), on behalf of Defense Threat Reduction Agency (DTRA).

And then of course there is New Jerseybased Hurel Corp. which develops and commercializes similar 3D bio printed products. Hurel was a spin out from Schering Plough (now Merck) labs from 2007. The company is now backed by Sanofi. According to MedCityNews,

It [Hurel] has raised $9.2 million in a Series A round for its lead product – a technology that replicates the human liver, using living cells, and referred to asorgan-on-a-chip or human-on-a-chip.

Hopefully this also sounds very familiar to investors in Organovo, because this is in line with what Organovo hopes to launch in 13 months or so.

Beyond just livers, there are also other 3D bio printing companies focused on different tissues. Texasbased TeVido Bio Devices is focused on developing 3D bio breast tissues for breast cancer victims. This is similar to the larger and longer term ambitions that Organovo has for fully useable tissues. They havealready stated that they expect that it will take 7 years and at least $40 million in order to get to the beginning of clinical trials. Companies such as TeVido and Organovo can therefore expect a long and expensive slog before they are even able to contemplate the beginning of FDA trials on such products.

But competition for developing 3D tissues and assays is not just limited to Europe and the US. It has become an explosive business in China. Already theHangZhou University of Electronic Science and Technolgy is printing 3D bio printed body parts. Likewise a company called Unique Technology based inQingDao has already supplied its 3D bio printers to dozens of universities acrossChina.

 

There is also competition emerging offering to provide 3D bio printers more broadly to other organizations. Germanybased envisontec already commercially sells a 3D bio plotter which can be viewed here.

For those who wish to look further, there are dozens more institutions and organizations which are actively involved in 3D bio printing. For those who are interested in seeing many more, I included a short list of the 3D bio printing partners who work with Insphero as Appendix II.

The first issue here is that there are numerous other 3D bio printing entities aside from Organovo and that some of them are clearly further along than Organovo.

But the more important issue is that these dozens of other 3D bio printing entities do NOT get the benefit of daily hype articles from sources such as the Motley Fool. This is simply because they are not publicly traded and no one (ie. motivated shareholders) benefits in the short term from giving them excessive hype and sensationalism. It is very important for investors to realize that speculative companies with tradeable stocks get far more attention than their private counterparts simply because traders want to profit from stock moves.

Looking more closely at the 3D liver assay product

The low price of the 3D liver toxicology assay should not come as a surprise to anyone who knows pharma testing. 3D liver assays will not fully replace traditional testing methods anytime soon. The pharma companies will still conduct first line animal testing, and will then proceed on 2D liver tissue samples and then conduct the 3D test last.

The concept of a “3D bio printed liver toxicology assay” sounds very exotic (and presumably expensive) to many retail investors, but in fact it is just another fairly simple diagnostic test for pharma companies. Many investors might not realize that the thickness of these “3D” samples is in fact just a mere 1 millimeter. It hardly appears to be “3D” at all, but it does in fact meet that definition from a technical perspective.

At present the biggest technical challenge is in creating the vascular structures for delivering blood that is necessary to support thicker structures, so 0.5-1.0 millimeters is the current limit for thickness of these tissues. We could certainly print thicker samples with a bio printer. This is physically achievable. But they would quickly die for lack of blood flow. At less than 1 millimeter the blood circulates by simple diffusion such that vascular structures are not necessary.

According to Organovo CEO Keith Murphy,

Murphy cautions. “Our ability to make tissue thicker than about one millimeter is restricted by our ability to deliver nutrients and oxygen to the cells. Today, nobody can integrate the small vessels and capillaries needed for thicker tissue. Therefore, we’re not making whole organs,” he stresses, although doing so may become possible eventually.

This reality may come as a shock for those who envision Organovo as a company which prints large and thick human organs using a 3D bio printer. Many are not aware of the 1 millimeter limitation. The reality is that even getting to just one millimeter in thickness has been a massive challenge and accomplishment.

The real point is that for pharma companies this just another simple 1 millimeter liver diagnostic which will hopefully offer additional predictive value prior to determining whether or not to go into clinical trials. And we can see that the cost of these tests is around $2,000 or less for a 96 well tray which gives the ability to conduct 96 individual tests. Interested readers should feel free to verify these numbers with Organovo management, with companies such as Insphero or with analysts such as Jason Napodano or other 3rd party sources.

It all comes down to Intellectual Property (“IP”)

The reason that there are so many competitors in the US, Europe and China is that there are still tremendous amounts of IP which are available through hundreds of universities which have been focused on 3D bio printing for as long as a decade. There are many ways to achieve similar ends and 3D bio printing is still in its infancy. As a result, patenting one’s own process certainly does not prevent others from obtaining their desired outcomes through slightly different means.

The technology being used by ONVO was licensed from the University of Missouri in 2009 for just $25,000 along with 1-3% of future revenues, if any. In 2010, the company entered into further licensing agreements for additional technology for just $5,000 plus reimbursement of patent costs. In 2011, ONVO entered into similar licensing agreements withClemsenUniversity for a total of $32,500 plus an additional $32,500 in patent costs.

As of 2013, the value of all of ONVO’s non cash assets (ie. all of its intellectual property) was valued at less than $900,000. This should not be surprising when one realizes that the only product currently on the horizon is the drug toxicology liver assay which commands a low price of less than $2,000 and a small market size of perhaps 1,000 units per year.

In the meantime, ONVO only spends a mere $1 million per quarter in R&D expenditures.

Significant transformation in the world of technology and biotech is tremendously expensive. This holds true without exception. For example 3D systems still spends over $10 million per quarter on R&D even though its technology seems to be at a more mature state. And in developing an electric car that will actually sell, Tesla Motors (TSLA) spends over $50 million per quarter !

By contrast, Organovo spends around $1 million per quarter and its total IP (which it purchased) is valued at well under $1 million.

The one thing that Organovo has done quite successfully is to raise over $60 million from investors due to the strong share price. Yet much of the share price strength has resulted from hyper bullish articles from authors who engaged in pure speculation about bio printed full organs and other outcomes which are clearly decades in the future. Despite all of the hype and the soaring share price, the stock continues to be held 93% by retail investors and has attracted no mainstream Wall Street research coverage. In fact, the heaviest source of promotion for Organovo is via the presentations atRetailInvestorConferences.com. This should be seen as highly unusual even for companies with market caps even as small as $200-300 million, and certainly unusual for a company which has now surged to over $1 billion.

The point from this is that there is a very clear reason why Organovo has attracted no institutional or research interest. Organovo bought some very inexpensive IP 5 years ago. The company spends very little on R&D and its only near term product offering is for a simple diagnostic which is already on the market from other competitors. Meanwhile, Organovo has heavily targeted retail investors and has been able to use that hype to raise around $60 million over two years from stock sales.

What are the insiders doing ?

Looking at the insider behavior at Organovo is very interesting.

Over the past few weeks (and as the share price was soaring due to articles), CEO Keith Murphy has sold 200,000 shares of stock, bringing him in nearly $2 million. On each case his SEC filings were stealthily submitted after the market close and on a Friday, such that many investors may not have seen this at all.

Chief Strategy Officer David Eric has also sold nearly 100,000 shares.

CTO Sharon Presnell recently sold 75,000 shares, and sold and additional 75,000 shares in August.

Of greater concern is the fact that on November 8th, Organovo filed a massiveS8 registration statement which now covers 11 million shares to be issued to management. This represents nearly 13% of the company and would be valued at well over $100 million for this small group of individuals. S8 filings are often sources of concern for investors because they basically allow management to issue large amounts of stock to themselves or their “consultants” for any reason. The filings can be done on very short notice. S8 filings were a much abused vehicles by Chinese reverse merger companies during the wave of fraud that hit these companies in 2010-2011. They used these S8′s to issue large amounts of stock to themselves and their cohorts and then quickly sold the stock at highly inflated prices. S8′s were largely how many of the Chinese fraudsters made themselves rich. This does not mean that all S8′s are bad. It just means that it is an easy way for insiders to award themselves tremendous amounts of stock on very short notice. Investors should rightfully view large S8′s with skepticism.

And by the way, this recent S8 registration statement by Organovo was again stealthily filed by management on a Friday (Nov 8th), well after the close of the markets such that most investors did not even see it. The filing of this massive S8 fortuitously coincided with the recent ramp of the stock following a string of bullish articles.

The point from this is that management can feel free to sell as many of their current shares as they wish, because they know that they can simply issue themselves another 11 million more.

Going back further, we can see other interesting insider activity.

As of the initial public offering in 2012, company founder Gabor Forgacs owned 13.9% of the company. As an owner of more than 10% of the company, he would have been required to report any sales of his stock.

Also at that time, his son Andras Forgacs held 1.8% of the company and was a director. This is below the 10% threshold, but as a director he would still have to report any share sales.

By December 2012, Gabor Forgacs had reduced his stake to 12%. But by April of 2013, he had reduced it to 9.7%, beneath the 10% reporting threshold. This was just prior to the uplisting in 2013, when the stock soared for the first time to over $8.00, up from around $1.00 a year earlier. And by being below the 10% threshold, Mr. Forgacs would not have to report that he sold his stock. We can see from SEC filings that Mr. Forgacs has not provided any information about holding any Organovo stock since 2012. Mr. Forgacs resigned from the board in 2012 such that this stock sales also would not be reportable. We therefore cannot tell how many (if any) shares Mr. Forgacs still holds. But the pattern of his actions appears to have been conducive to being able to sell when he wanted to without having to report the sales which would alert investors.

Meanwhile, his son Andras resigned from the company in July 2013, also as the stock had just hit all time highs at the time. This would also allow him to sell his stock without reporting it. There are also no subsequent updates indicating that Mr. Andras continues to hold his original position so we really don’t know.

The last filings indicating ownership by the Forgacs were in March of 2012.

But perhaps a bigger question for investors is why did the founder and his son resign from this company at all ? If the future is so bright for Organovo, then presumably these two founding insiders would want to go along for the ride.

A word on Organovo’s collaborations

Like many development stage biotech and healthcare companies, Organovo was able to secure several collaborations with big pharma names. In 2010, they secured a deal with Pfizer and by 2012 they had delivered constructs to Pfizer for internal evaluation. No update has been provided since then as we now approach 2014. In 2011, Organovo entered into a research agreement with United Therapeutics. The agreement had later been expanded, but it appears that it still expires several months from now. In January of 2013, Organovo entered into a collaboration agreement with the Knight Cancer Institute atOregonHealth & ScienceUniversity (“OHSU”), to develop more clinically predictive in vitro three dimensional cancer models with the goal to advance discovery of novel cancer therapeutics. However this is purely academic and does not appear to provide any revenue to Organovo. Additional recent announcements have been made including Hoffman LaRoche and L’Oreal but no revenue from these has been disclosed either.

These name brand collaborations have added instant credibility and have occasionally boosted the share price. But the fact remains that in the past these big names have paid up to have a look at what Organovo has for them, and then they have moved on after looking.

This should be readily apparent by looking at the amount of collaboration revenue which has been steadily dwindling each quarter. As of the most recent quarter, Organovo brought in just $23,000 in collaboration revenue. By contrast, in 2012 the total for the year was over $1 million.

Learning from the past – have we seen this before ?

At the beginning of 2013, Casey Research published an article describing the then-recent moves in the stock, which were also spectacular. The description provided by Casey is now about a year old, but should seem oddly familiar to those who have witnessed the moves of the past few weeks. Investors should read this carefully, keeping in mind that it describes a the effects of a promotion that happened over a year ago !.

From Casey Research:

ONVO went public at $1.65 per share on February 14, 2012 and experienced some impressive momentum out of the gate, climbing to $3.01 (an 82% increase) by May 17. That’s when things really went crazy. Just one month later [IN JUNE 2012], ONVO traded as high as $10.90 (a 560% increase from the close on its first trading day just four months prior) after some of the larger newsletter companies like Motley Fool wrote numerous positive articlesabout the company and helped propel it to a $500-million market cap (despite no change in fundamentals) virtually overnight.

Think about that for a second. ONVO was trading for half a billion dollars despite generating less than $1 million in revenue during the prior twelve-month period. Yes, that’s a price-to-sales ratio of over 500. And it’s not like theforward one- or even two-year revenue projections were calling for growth that could come close to justifying that valuation. The numbers just didn’t make sense. When investors once again came to their senses and recognized this reality, the stock fell – hard. By mid-July 2012, ONVO was once again trading below $2.00 per share. Despite a brief pop above $3 per share in mid-October, the stock remained flat through mid-December.

The point from this excerpt is that we have seen the exact same phenomenon again. It is a series of hyper bullish articles (also coincidently coming primarily from the Motely Fool) all coming at the same time which sent this stock soaring within 2 weeks and without any new fundamental developments from the company. Casey makes a good point as well. Investors shouldn’t be looking at the current price to sales ratio, they should be looking at the 2-3 year forwardprice to sales ratio. As shown above, revenue for 2015 should not be much more than $2 million under any circumstances. But now we are at over a $1 billion market cap such that the forward price to sales ratio is still at least 500 times projected sales. And even if they grow these sales in 2016, we are still talking about 200-300 times sales.

Conclusion

There is an old saying that if you repeat a lie often enough, it becomes “the truth”. This does not mean “truth” in the literal sense, instead it just means that the lie becomes universally accepted.

Lately the headlines have been filled with bullish articles on Organovo which predict massive near term revenues as a result of providing billion dollar savings to big pharma companies. Many of these articles have been written by individuals who happen to own stock in Organovo and who have certainly derived great benefit from the recent doubling of the stock in two weeks.

The actual truth is that Organovo hopes to launch a fairly simple 3D liver assay in 13 months from now. It is hoped that this product will offer some incremental benefit above and beyond animal testing and 2D testing. Existing products are already on the market and sell for less than $2,000 for a 96 well tray. The total market size for all such liver assays for all competing suppliers numbers in the mere thousands of units.

As a result, Organovo’s revenue potential should be expected to add up to just a few million dollars over the next few years – certainly NOT hundreds of millions of dollars. And in fact, NOT even tens of millions.

But the sheer repetition of this misinformation of late has caused Organovo’s share price to double in about 2 weeks, now hitting a $1 billion market cap. The latest surge has been driven by high volume momentum traders who do not even care what the company does. These traders are also agnostic about share price direction. They are just as happy to profit from falling share prices as they are from rising share prices. They can exacerbate downward moves in the share price just as they have exacerbated the recent upward moves. As a result, as soon as investors realize the reality of Organovo’s actual revenue potential, the share price should be expected to see dramatic moves lower on very high volume.

In the meantime, management insiders continue to sell large amounts of stock at current prices pulling in millions of dollars personally. And now they have registered over 11 million more new shares to give themselves. Organovo as a company will certainly not be pulling in $100 million in revenue any time soon. The only ones to get this much money will be Organovo management when they personally award themselves the 11 million shares of stock under the recently filed S8.

Appendix I – practical considerations for shorting Organovo

Following the dramatic spike in the share price, many investors have lamented to me that shorting Organovo is often “impossible” due to lack of stock borrow..

A much better alternative is to sell the December call options. When selling options with a fairly low strike price of $5.00, the performance is basically identical to shorting the stock. Investors get 1:1 exposure on both the upside and the downside. The only drawback is that if the share price falls below $5.00, the investor no longer benefits from additional downside. But the major advantage here is that selling calls does not require the short investor to borrow stock, so there is no expensive borrow fee. In reality, selling naked options like this is often no more risky than shorting common stock. It does require an additional level of option approval from one’s broker, but this is well worth it because this technique applies to many stocks aside from Organovo.

Another alternative is to buy the “in the money” puts. Many investors shy away from puts because they are seen as being a very risky “all or none” bet. That certainly applies to “out of the money” puts. But if the stock price is below $12.50 and the investor buys $12.50 puts, he is already “in the money” and the option will largely perform 1:1 on the way down just like being short stock. As with selling calls, the short investor does not need to pay the expensive borrow. However there is typically a moderate premium that must be paid. So if the stock is at $11.50, the investor might pay $1.50 for the $12.50 put, effectively getting short at $11.00. Because the stock is at $11.50, the investor has paid a 50 cent premium. One advantage here vs. being short the stock is that if the share price does rise dramatically, the investors losses are capped at that $12.50 level. But should the stock fall back to $8.00, this $1.50 bet pays off $4.50 (a triple). And again, if the stock rises above $12.50, the investors losses are capped.

Appendix II – A few more 3D bio printing partners who you’ve likely never heard of

Cyprotex, UK

Cyprotex is an expert in-vitro CRO, that is using InSphero 3D liver microtissues for compound de-risking

http://www.cyprotex.com


Hamilton Robotics

A leading global supplier of liquid handling robots with proven 3D experience.Hamilton’s systems are in use at InSphero for large-scale production of microtissues.

http://www.hamiltonrobotics.com


INTEGRA Biosciences AG

Offers a range of automated hand-held and bench-top pipetting instruments ideally suited for production and assaying of 3D microtissues in InSphero’s GravityPLUS Platform.

http://www.integra-biosciences.com


Luxcel Biosciences Ltd., Ireland

Luxcel Biosciences develop and provide phosphorescence and fluorescence based sensors for use with InSphero 3D microtissues.

http://www.luxcel.com


Perkin Elmer Corp.

Working closely with InSphero on integrating InSphero GravityTRAP assay plates for 3D microtissues into their Opera and Operetta High-Content Analysis systems for functional imaging.

http://www.perkinelmer.com


Promega Corp., USA

A leading supplier of assay kits, who works closely with InSphero since 2010 to validate and to optimize assays for use with 3D microtissue spheroids.

http://www.promega.com


SIRION BIOTECH GmbH, Germany

Develops genetically modified 3D microtissue solutions using InSphero’s GravityPLUS system.

http://www.sirion-biotech.com


Solentim Ltd., UK

The fully automated bench-top system CellMetric for measuring visual, non-invasive cell content will soon support automated assessment of 3D microtissue size in the GravityTRAP plate.

http://www.solentim.com


Sophistolab AG, Switzerland

InSphero’s partner for histological analysis of 3D microtissues with a strong expertise in immuno-staining and microtissue handling.

http://www.sophistolab.ch

Disclosure: I am short ONVO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

 

TearLab to plunge on steep earnings miss

dry eye

Investment thesis

TearLab Corp (TEAR) has so far managed to drive moderate increases in revenue over the past year, but only by spending a disproportionate amount on marketing. The result has been ballooning losses in every quarter. The company has never earned a profit. Following dozens of recent calls to the offices of eye doctors, it has become apparent that the adoption of the TearLab product tends to be fleeting and driven primarily by the marketing spend. As a result, the temporary boost in revenues resulting from this marketing tends to be short lived and must be constantly replaced with new doctors who will give the product a trial. Investors should be concerned that TearLab now gives away its desktop reader for free in order to encourage doctors to make a trial of the product.

TearLab recently laid out a large seven figure pay package (roughly in line with a full quarter’s revenue) to hire Seph Jensen from Alcon Labs. His start date was scheduled to begin just prior to the upcoming earnings release. This expensive hire should also signal the company’s desire to telegraph a much needed turnaround to stem ballooning losses. The timing was likely urgent in order to have a visible solution in place prior to announcing disappointing earnings. TearLab is likely to report a much larger loss on revenues which are flat to down. The result is expected to be a share price decline of at least 25% to around $8.50 or below. The hiring of Mr. Jensen will be positioned as a means of addressing these problems going forward. On the earnings call he will certainly announce the company’s plans for reducing the ballooning losses.

Background information

Lately I have done quite well on several trades by aggregating information from non-market sources ahead of earnings releases and placing my bets accordingly. There is nothing illegal about this. Information which can be obtained by customers, suppliers and competitors is all fair game as long as it is not supplied by company insiders. As described below, Tesla (TSLA) follower Craig Froehle recently conducted similar analysis right ahead of the $25 plunge at that company.

In August, I wrote an article just before the release of earnings at Francesca Holdings (FRAN) which predicted that an earnings miss would lead to a 30% drop in the share price. A few days later, Francesca disappointed as predicted and the share price quickly fell from $25.00 to less than $18.00. Analysts had continued to maintain price targets as high as $38.00, so they were wrong by about 90%.

More recently, I predicted a similar 30% drop upon the release of earnings by Ignite Restaurant Group (IRG). Analysts had predicted that earnings might decline a bit, but continued to maintain price targets of around $17-18. Following the release of earnings this week, Ignite quickly traded down to below $11.99, also a nearly 30% decline from the time of my article a few days earlier.

To me, both of these trades were painfully obvious. Rather than rely upon the bullish views of sell side analysts, I turned off my computer and left my desk to conduct my own research in person. With Francesca, I visited numerous stores in various cities over the span of several months. I then called dozens more and scoured the internet for evidence of discounting. In its prior earnings call, Francesca had noted that its practice of deep discounting was coming to an end and margins would rebound accordingly. Analysts believed and repeated this view almost verbatim. But my months of research showed that the discounts were actually accelerating rather than declining. A steep earnings miss was all but guaranteed. When it was reported, the stock quickly plunged as it should.

Prior to writing about IRG, I visited and called numerous restaurants across multiple states and interviewed employees on each occasion. I also aggregated information on the availability of discounts. It was clear that the company’s turnaround strategy was failing and that traffic was falling despite heavy discounting. The combination of much lower traffic along with deep discounts meant that IRG was all but guaranteed to report a loss rather than the analyst-predicted profit for the quarter. As expected, the share price dropped to below $11.99, closing in on a new 52 week low.

This type of analysis is now becoming more widely used by a wider array of investors. Investors have come to realize that the reports and targets of sell side analysts are typically useless or downright dangerous. They are often little more than gratuitous quotes from management along with lofty share price targets which get re-raised every time the share prices rise.

Just prior to the release of Q3 earnings by Tesla, Seeking Alpha author Paulo Santos wrote an article highlighting Craig Froehle’s use of VIN number tracking to get an estimate of vehicle production and sales at Tesla Motors . Mr. Santos states that

The VIN data continues to be consistent with U.S. demand for the Model S having peaked, and indeed, it’s now consistent with that demand having already weakened substantially.

One day later, seemingly bullet proof Tesla began a plunge of more than $30. The point is that this type of grass roots analysis is becoming far more useful in predicting share prices and earnings than the reports of ever bullish sell side analysts.

An earnings miss at TearLab should now be obvious

Just one year ago, TearLab was trading at below $4. The stock has since risen as high as $15 – almost a quadruple. At its peak, TearLab hit just over half a billion in market cap.

The driver for the rise in the share price over the past year has been analyst enthusiasm over revenue growth. On a percentage basis, the revenue growth has in fact been quite large, in the range of triple digit percentages. But this is simply due to the fact that it is growing off of a very small base of just over $1 million. The rise from a $4 share price to a $15 share price has occurred even though revenues have risen from around $1 million to just around $3.5 million. Yet the quarterly loss has increased from $2 million to over $12 million.

Recently the stock has been trending down towards $10 in advance of the upcoming earnings release. The reason should become apparent.

TearLab most recently reported revenues of just $3.5 million, up by $1 million from the previous quarter. But its net loss ballooned from $8 million to $12 million in a single quarter. The problem is clear. In order to increase revenues by just $1 million, TearLab must incur a massively disproportionate increase in its net loss.

Over the past few quarters, this revenue trend has looked as follows:

(click to enlarge)

Analysts have been operating under the theory that at some point TearLab will end up generating enough revenue to break through the losses. But it should be kept in mind that the TearLab product has been on the market for over 5 years and significant sales have yet to materialize. The recent growth of $1-2 million in sales has been largely the result of a sharp increase in marketing spend. The result of the heavy spending has been the steep surge in losses.

This might be an acceptable strategy if it was one that led to a sustained increase in revenues in the long run. But with TearLab, it appears that the marketing spend is often successful only in getting doctors to agree to an initial test of the system for a limited period of time. When they fail to continue using it, it means that the marketing spend is largely wasted and the revenues evaporate. TearLab then continues with its marketing spend in an attempt to get more new doctors to conduct an initial rest of the system.

TearLab’s most recent earnings call was very brief. The company reported record revenues of over $3 million in a quarter, but the company lost over $12 million for the quarter. As a result, the company has already lost more in 1H 2013 than it did for full year 2012, its previous worst year ever.

The revenue vs. net loss for TearLab over the past 4 years is as follows. (The last column on the right is YTD 2013).

(click to enlarge)

Instead of discussing the earnings miss directly, the majority of the earnings call was spent hearing a panel of hand selected experts offer their praise for the TearLab system. Of the 4 individuals, 3 were eye doctors while 1 was the CEO of the OCLI eye practice.

At the risk of stating the obvious, it should come as no surprise that the panel of 4 which were hand selected by TearLab had very positive things to say about the product. Among the doctors, some of them had been long term TearLab supporters going back for multiple years. For example, Dr. Marguerite MacDonald is featured in TearLab’s investor presentation and has served as a TearLab promoter for several years (as seen here on YouTube in 2011). Her support for TearLab has been unwavering, but it sheds little light upon the adoption of the product by newer doctors who are not dry eye aficionados.

A much more instructive approach is to contact a wider assortment of doctors’ offices who are familiar with the product and get their review. In order to achieve this, one can simply call the numbers listed on TearLab’s website under “Find a Doctor“. When prompted for location, simply click “view all locations“. A convenient list of all TearLab customers (along with their phone numbers) then appears.

Over the past few weeks, I have contacted dozens of these doctors to ask about their recommendations for conducting a dry eye exam. I did not discuss any interest in TearLab as an investment.

As would be expected, there are a large number of doctors from TearLab’s list who do recommend a tear test. What does come as a surprise though, is that there are also a large number of doctors who have received the test over the course of the past year but no longer offer it, citing lack of need, inaccuracy or difficulty in getting reimbursed.

The doctors who do not recommend TearLab’s test end up recommending the more standard Schirmer test which has been used for many years along with a simple verbal assessment.

In fact, this should not come as a surprise. After more than 5 years, use of TearLab’s test is still the vast exception to the rule. Healthcare sites such as theMayo Clinic do not mention TearLab’s tear osmolarity test at all. Instead they recommend the Schirmer test or simple verbal assessment.

The list of doctors on TearLab’s website can be somewhat difficult to track. During the course of my research, there were a number of additions to the list, representing new doctors who appear to have been added in recent weeks. But there were also some deletions representing doctors who must have either returned or abandoned the test.

TearLab had previously noted that less than 5% of doctors have ever returned a test to TearLab. However this does not account for the units which have simply been discontinued in the practices of eye doctors nor does it account for doctors who have a test unit but see no reason to use it over verbal assessment which is easier and free and is not time consuming for the busy doctors.

The point from this is that the effect of TearLab’s marketing spend often appears to be only in getting some doctors to try the test for an initial and limited period. This clearly leads to a short term rise in revenue, but also a disproportionately large increase in marketing expense. When the revenue is only short lived, this becomes highly problematic. This is likely what we have been seeing over the past 5 quarters and it explains the slight rises in revenues along with much larger increases in the net loss at TearLab. TearLab appears to be constantly in search of new doctors to replace the ones who will not adopt the test after using it.

Looking at TearLab’s product

A heavy marketing budget can drive sales of virtually any product for short periods of time. But ultimately a product will need to justify itself if it is going to sell on its own.

The biggest problem with TearLab’s product is that is just isn’t necessary for the majority of eye doctors. It is certainly true that the product is well liked by specific dry eye specialists (such as those on TearLab’s last earnings call).

The TearLab test allows doctors to quantify tear levels with a numerical score. This is why the true dry eye only specialist practitioners like it. But for the regular eye practitioner, this level of information is simply superfluous and is certainly not worth paying for or taking the extra time from other waiting patients.

In most cases, doctors will simply ask their patients to describe their symptoms and then prescribe corrective measures accordingly. This is not only faster, but it is also free. It also addresses the problem to the satisfaction of the patient.

In some cases, doctors will use the industry standard Schirmer test.

The TearLab test does not offer the majority of practitioners any useable new information. Either a patient has a condition worthy of treatment, or they do not. This is primarily based on level of discomfort. The numeric score does not really add much additional value in a practical setting.

In addition, because the test costs less that $30, there is very little revenue potential for the eye doctor. As a result there is neither an overwhelming financial or medical incentive to use this test. It simply consumes time from office visits along with space on the desk for the TearLab unit.

This is why the test which has been around for more than 5 years still only shows a few million dollars in sales and why these sales only tend to increase when accompanied by a disproportionate marketing spend.

TearLab’s method of dry eye testing has been described as the “new gold standard” for dry eye testing since the early 1990′s – nearly 20 years. It is by no means a new technology waiting for widespread adoption.

In addition, TearLab continues to cite a whopping $1.5 billion market potentialfor the product based on hoped for sales to an estimated 50,000 eye doctors in the US. This massive market potential claim has been consistent for years. Yet after all of this time, new product sales continue to measure in just the hundreds of units for the entire year. The device simply doesn’t sell even after 5 years of marketing.

By this measure, use of TearLab’s test accounts for roughly 2% of applicable dry eye tests per year. And it should be remembered that even this low level is only the result of a very heavy marketing spend.

In effect, the heavy marketing spend has resulted in a small number of doctors trying the test for limited periods of time. But over the past 5 years, there has been no consistent adoption of the test at a meaningful level. While marketing spend may get doctors to try the test, it does not get them to continue using it. As a result, TearLab is on a never ending search for more new trial doctors.

The hiring of Seph Jensen

On October 1st, TearLab announced the hiring of Seph Jensen from Alcon Labs where he had previously served as Head of Surgical Marketing. The announcement quickly sent the stock soaring to as high as $12.33. Since that time, the stock has now retreated by around 15%, giving up most of its gains.

The reason for the quick jump in the share price was obvious. At Alcon Mr. Jensen oversaw $1.4 billion in sales. If tiny TearLab with just a few million in sales could attract this type of talent, then the company must be really headed in the right direction.

Unfortunately there also appears to be a very different explanation for the timing of this hire.

Mr. Jensen was set to start with TearLab on October 31st, just two weeks before earnings are to be announced. It is very likely that the company will report a large earnings miss. Hiring Mr. Jensen will not help to explain the miss which just happened. However, it will allow the company to show shareholders that it is attempting to do something to slow the ever increasing losses.

This view is supported by the fact that Mr. Jensen’s compensation package wasastronomical for such a small company with minimal revenues and ongoing losses. Mr. Jensen will receive a base salary of $370,000 which is moderate. But he will also receive up to an additional 50% of this amount as an annual bonus. He also gets a signing bonus of $250,000. So the initial payments amount to just under $1 million. However, he was also granted 300,000 shares worth of options with a staggering 10 year maturity. The value of these options alone is worth well over $2-3 million alone. For reference, even short dated 1 year at-the-money options on TearLab are worth around $2.50 per share at present.

All in all, the pay package awarded to Mr. Jensen is worth somewhere between $2-4 million at minimum, which is in line with a full quarter’s entire revenue for the entire company. For reference, the entire SG&A expense for Q1 was only $3.9 million. Yet a similar amount is now being awarded to a single executive. The point is that Mr. Jensen should be viewed as an extremely expensive hire for TearLab.

The timing of this very expensive hire coming just before earnings suggests that TearLab is looking to provide investors with some level of comfort in the face of another quarter of ballooning losses. In any event, there is nothing out there to suggest that there has been any change leading into this quarter which will stem the pace of the accelerating consecutive losses from past quarters.

Conclusion

In recent cases, aggregating non-market information helped me accurately predict a significant earnings miss which presaged a quick share price decline of around 30% in several stocks.

Prior to the release of earnings for Francesca and Ignite Restaurant Group, I came to the conclusion that an earnings miss was highly likely in each case. I came to this conclusion based on dozens of phone calls and in person visits which revealed that business was not going to live up to the highly bullish expectations of analysts who cover the stock. The on the ground information I obtained was far more useful that the reports from analysts which simply repeated the views of management.

Making dozens of visits and phone calls is far from a scientific approach, but it has proven to be consistently useful to me.

With TearLab, I have called dozens of eye doctors to ask about their use of the TearLab product. I specifically called the doctors who are currently (or were previously) listed on the TearLab web site as carrying the TearLab test.

While there are naturally a large number of doctors who do carry this test, there are also a surprisingly large number of doctors who had previously used the test but who no longer recommend it to prospective patients. Even among the doctors who do carry it, they do not necessarily state that it is part of their standard dry eye exam. The Schirmer test and verbal assessment tend to remain the standard even among many TearLab customers.

The conclusion from this is that the revenue gains from TearLab’s expensive marketing efforts in some cases end up being very short lived. In many cases the doctors noted that there were several options for evaluating dry eye conditions. But in only a few cases did the doctors immediately tell me that the TearLab solution was a must.

The conclusion I have reached is that TearLab is likely to once again show a very large increase in marketing spend which will be accompanied by revenues which are either flat to down. This is simply due to a relatively underwhelming adoption of the tear test despite the heavy marketing spend. The result will be a loss which is larger than last quarter and which is moderately to significantly larger than expected by the street.

Mr. Jensen will then be given the stage to explain how things are about to change in coming quarters.

I am expecting TearLab to fall to around $8.00-$8.50 following earnings, with potential for further downside in the weeks that follow.

In the meantime, TearLab is a company which sports a $350 million market cap despite cumulative revenues of just $15 million over the past 5 years running. During this time, cumulative losses are now approaching $50 million without a single profit, with losses continuing to grow each quarter.

Disclosure: I am short TEAR. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

IRG: Watch for a big earnings miss

macaroni

Investment thesis

Restaurant stocks have been going through a very tough earnings season. Of the six restaurant groups to have reported so far, five have reported earnings misses. As a result, there has been significant share price weakness following earnings at companies such as Ruby Tuesday’s (RT), Darden Restaurants (DRI) and Dominoes Pizza (DPZ).

Ignite Restaurant Group (IRG) is on deck to report earnings and all signs point to a significant earnings miss. The shares have traded flat for 2 months and could see a decline of around 30%. Given the abundance of data points coming from all angles, this should not come as a surprise to anyone. A large sale by the backing private equity fund could also contribute to further pressure.

Background

Back in August, I made an earnings call just ahead of the reporting date for Francesca Holdings (FRAN). I predicted that the clothing retailer would report weak same store sales and that discounting would continue to pressure margins. My share price target called for a quick 30% drop. Within days, Francesca’s reported their results and they were exactly as predicted. Discounting had accelerated and margins had come under pressure. The shares quickly dropped by 30% to around $17.00.

In fact, these predictions were fairly easy to make. Most of Francesca’s competitors had already reported difficult results and their share prices had tumbled. Many of these competitors even operate in the same malls as Francesca’s such that they suffered from the same weak traffic. I also made it a point to visit in person and call numerous Francesca stores over a period of many weeks so that I had a solid idea about the discounting practices in place during the quarter. My article made all of this clear.

In short, no one should have been surprised by Francesca’s poor results. But the analysts were clearly surprised. They maintained their targets at over $30.00, only lowering them after the big miss. Clearly this helps no one. For some reason, they saw no need to conduct store visits and interviews to support their targets. Likewise, we can see that many investors were also surprised. These investors have just begun filing class action lawsuits against management for not revealing the discounting practices which I described in my article before the miss was reported.

Looking at the restaurant space, we can see a very similar phenomenon unfolding. It is now easy to see that the biggest loser in the near term is going to be Ignite Restaurant Group which is likely to decline by at least 30% following earnings next week. The company is suffering from 3 years of continuously declining sales at its recently acquired Macaroni Grill. These declines are now accelerating rather than reversing. Majority shareholder JH Whitney currently owns 68% of Ignite. However a registration statement filed in July now covers the sale of these shares. The timing for such a sale looks very good for Whitney. But it will certainly put heavy pressure on the share price.

According to its latest 10Q, Ignite is now down to just $1 million in cash. Current liabilities are $106 million vs. current assets of just $40 million. The company now has long term debt of $93 million plus another $13 million due within 12 months. For all of 2013 and 2012, cash from investing activities has more than consumed all cash generated by the business as the company tries to expand its way into profitability. However the company has been losing money in two of the past three quarters. In the one profitable quarter, net income was just $2 million on $118 million in sales.

The company still suffers from multiple weaknesses in internal controls which resulted in the restatement of several years of financial results. Following a plunge in the stock, there are still shareholder lawsuits outstanding. For these reasons, Ignite is among the weakest and most vulnerable of all of the restaurant groups.

As I did with Francesca’s, I recently called and visited numerous Macaroni Grills across two states. Interviews with staff there consistently revealed the existence of significant discounting along with fairly slow traffic over the past 6-10 weeks. The results of these interviews are just one of the reasons that I expect revenues to be flat to down with significant pressure on margins resulting in a noticeable net loss.

A second reason is that we can already see that most of Ignite’s close competitors have been pummeled by poor results. The significant and persistent slowdown in the casual dining space should now be widely known. This was identical to the disappointing results reported by competitors in advance of Francesca’s. Yet many investors ignored these obvious signs and only sold after the disappointment and plunge.

Ruby Tuesday’s is down by 25% in the past few weeks following difficult results and a poor outlook for its turnaround strategy. Darden Restaurants also took a hit of 10-15% following its weak earnings. Darden operates a number of casual dining chains including Red Lobster and Olive Garden.

Shares of BJs Restaurants (BJRI) are down by nearly 30% since its last earnings date. Shares of Del Frisco’s (DFRI) are down by nearly 20%. Shares of Brinker International (EAT) are down by more than 12% since August.

Even Dominos Pizza recently skidded when it missed earnings. Dominoes is at the low end of the price spectrum such that it is usually expected to be more resistant to sector wide slowdowns than many other competitors.

The only competitor to have done well this season has been Wall Street darling Chipotle Mexican Grill (CMG). Chipotle continues to be a very strong stock that seems capable of doing no wrong.

In short, the environment for casual dining stocks has been consistently bad for most direct competitors. It should be noted that the majority of these competitors can often be found within close proximity near the same shopping malls and office complexes. As a result, their sales performances tend to be highly correlated.

Shares of Ignite have been basically flat over the past two months. However, volume has been low. This has been the case despite the fact that the problems at Ignite will have a noticeably greater impact than those of its competitors.

In its last quarterly earnings announcement, Ignite disclosed a loss of $2.5 million. Revenues had jumped to $228 million, but these were driven mostly by its recent acquisition of Romano’s Macaroni Grill in April for $61 million.

By looking deeper, we can see that growth for Ignite’s core business (which excludes the Macaroni acquisition) has basically stagnated. The revenues for Ignite have historically been dominated by its Joe’s Crab Shack chain. In its most recent quarter, revenue from Joe’s increased just 0.7%. Revenue from its Brick House Tavern chain did increase by an impressive 6%. However, given that Brick House now contributes less than 5% of revenue to Ignite (only 16 stores out of over 300), this increase does not move the needle much at all.

In order to combat the revenue stagnation at Joe’s, management plans to open up to seven new Joe’s locations during all of 2013. But obviously these new revenues will come with a fairly substantial startup cost and ramp up time so it will take some time before results are felt. It will also take time to evaluate the real cost-benefit of those new, incremental revenues.

The biggest disappointment this last quarter came from the Macaroni acquisition. Romano’s Macaroni Grill has been struggling for years, reportingsequential declines in each year going back to 2010. The struggles appear to be getting more severe and more expensive.

On its earnings call, management made some troubling revelations:

During the due diligence phase of our acquisition and right up to the February 6, signing of the letter of intent, Macaroni Grill’s comp sales were right around innegative 5%; from February through April 9, when we closed on the business, comp sales deteriorated to a negative 11.5%. While there was no secrete to us that Macaroni Grill sales had been challenged for an extended period of time, the pace of deterioration in the first quarter was significantly greaterthan we had anticipated, and we felt that we needed to act very quickly.

Management noted that it completed a $2 million media buy to attempt to boost sales. This did help to slow the decline moderately. But in the end, Macaroni Grill sales still decreased by 7.4% vs. the prior year. And it should be noted that even this dubious victory still cost management $2 million which went straight to the bottom line.

These observations reveal two significant problems which are going to drive the earnings miss and share price decline at Ignite.

The Macaroni Grill now dominates the equation for Ignite. As of June 30th, there were 186 Macaroni Grills, 134 Joe’s Crab Shacks and just 16 Brick House Taverns.

The decision to substantially lever up to acquire the declining Macaroni Grill is a questionable one. Revenue from the chain was already in decline in each of the past 3 years. It has already declined by nearly 30% in that time. This was prior to the declines in 2013 which now appear to be accelerating.

In 2012, Macaroni lost $6 million on $390 million in sales. Sales are already on track to decline a further 25% from that level this year, following a 10% decline the previous year. Nothing seems to be able to slow the decline.

Management seems to indicate that the problems at Macaroni were larger and more expensive than they had expected. They have also admitted that they were “overconfident” in their ability to make a rapid turnaround of the chain. In effect, we have already been warned of what to expect from management.

The Macaroni restaurants were being staffed very lightly to deal with ongoing declines in business. But new management hopes to ramp up business, and therefore chose to increase headcount by 1,700 jobs. Management noted that:

At any rate a significant investment was made and clearly more than we have planned.

But here is the biggest problem. In order to maintain any type of longer term profitability, Ignite simply must effect a successful turnaround of Macaroni. But turnarounds take lots of time and lots of money before the results are felt or known. It is almost a certainty that the next 2-3 quarters (including this one) are going to be dominated by substantial turnaround expenses from Macaroni. If the turnaround works, we will then likely see results in mid 2014. But until that time there will be lots of pain in advance of the hoped for gain. It also remains to be seen if the surge in expenditures for a few quarters will end up creating a sustained boost to the results of the chain once deep discounting comes to an end.

Management has already committed itself to substantial fixed costs by adding these 1,700 new jobs. Many of the hires would not have been in place for the full length of last quarter. As a result, the expensive effect of these hires on net income will not be fully felt until this quarter. Management will also continue to spend heavily on media buys and the advertising budget. But as we saw last quarter, even spending $2 million did not end up increasing sales. It only slowed the rate of decline.

Perhaps the largest negative impact will come from the discounting of customer bills that is necessary in order to attempt to lure customers in to the stores. We can see from their website that there are multiple promotions ongoing which promise discounts to customers. Sales of alcohol are a leading profit driver for these chains. But Macaroni is now offering half priced wine priced at just $2.75 to attract customers. Visitors are offered $5 off for signing up for the mailing list. Group parties who pre-book get 15% off. Each time I ate at Macaroni Grill, the staff gave me discount coupons to come back again and get more taken off of my bill. It is clear that Macaroni Grill is trying to increase absolute traffic by cutting prices wherever possible.

According to the wait staff I spoke with, a new line of bigger promotions will be rolled out this weekend. Those who wish to gauge the impact of future discounts should check on Ignite’s website once these promotions are announced over the weekend.

But we can see from past promotions that these discounts have previously failed to boost sales. Coupon histories can still be found online which show that during late 2012 and early 2013 Macaroni Grill was providing half priced food and “buy one get one free” offers. These offers were made at precisely the time that sales for Macaroni Grill were showing their largest declines.

These offers are a devils bargain for restaurants. They often end up losing money on them, but they feel that they have no other choice if they want to stimulate the nominal level of sales and traffic.

During the most recent quarter, the Macaroni Grill returned to “buy one get one free” promotions. “Happy hour” with loss leading specials now lasts as long as 5 hours. This leaves very few prime time hours during which to offset those losses.

What we will almost certainly see at earnings is that the heavy spending and discounting will help to move the needle on revenues, but it will come at an enormous cost to margins and will contribute to a large net loss.

Given the accelerated discounting, it is almost guaranteed that the net loss in the current quarter will greatly exceed the $2.5 million from last quarter. In fact, the loss could even significantly exceed the $8 million loss reported in December of 2012.

Heavy discounting to stimulate declining traffic was exactly what we saw in the retail space with Francesca’s which led to its recent 30% plunge. The malaise is also identical to what we saw with the turnaround strategy at Ruby Tuesday’s. By now, the short term results of this type of strategy should be predictable. Investors will be forced to tolerate near term losses in the hopes that a rebound will happen in several quarters. But in fact, most investors will tolerate no such thing. They will tend to sell their shares now and re-evaluate once the results of the turnaround strategy become better understood in a few quarters.

Part of the problem in the restaurant industry is that these discounts have been absolutely pervasive this year. When every restaurant out there is offering deep discounts, it does little to help the business of any one of them. Instead, it just means that deep discounts are needed just to lure customers away from the other deep discounting restaurants. For those who are interested, here is just one of dozens of coupon lists where consumers can get deep discounts on meals from Applebee’s, PF Changs, Sonic, Cheesecake Factory, Olive Garden, Outback, Chili’s and on and on.

The conclusion is that many restaurants are now being forced to issue coupons and discounts. If they do not, customers will simply go to other chains which have large discounts. And when one restaurant stops discounting, consumers will just switch to the others that do. In the current environment, no one should be paying anything close to full price for meals in casual dining chains.

Share of Ruby Tuesday’s fell by 16% upon earnings. Stifel Nicholas describedthe situation for the brand in a research report as follows (readers should note that these comments appear to apply quite precisely to Ignite and other brands as well).

The persistent casual-dining sales slowdown has presented a more-than-challenging environment for an in-turnaround concept such as Ruby Tuesday that seeks to re-introduce consumers to its brand,” he said. “We continue to believe that mass-casual family dining names such as Ruby Tuesday willcontinue to underperform until the casual-dining sales softness that haspersisted throughout September shows signs of reversal.

So we now have the observations from above, along with statements from management and then comments from analysts. All of these consistently point to a very challenging environment for the comps and especially for turnaround stories like Ignite.

After viewing these similar assessments, no one has any excuse whatsoever to be surprised at a substantial disappointment from Ignite next week.

One question now is whether or not private equity firm JH Whitney intends to stick around for several more quarters to see if this acquisition can actually be turned around. The recent registration statement was filed in July. This was just a few months after the troubled Macaroni acquisition and just before the recent earnings disappointment was made known to investors. Whitney has two board seats at Ignite, so it should be fairly plugged in to the latest developments.

Whitney has already done well with this investment. The firm sold stock in the IPO at $14.00 and also received an $80 million cash dividend payment from Ignite before the IPO.

The acquisition of Macaroni has some interesting details. The target was acquired from Golden Gate Capital for $61 million in cash. Whitney and Golden Gate have some intertwined executive histories and they have also worked together in the past, most notably in taking Herbalife (HLF) private and then selling the company for a substantial profit.

The Los Angeles Times notes that

Whitney and San Francisco-based investment firm Golden Gate Capital Inc. acquired Herbalife for $700 million in 2002, putting up $176 million of their own money.

Shortly after the firm went public again in late 2004, it paid Whitney andGolden Gatemore than $110 million in dividends, filings show.

After the value of the shares more than doubled in 2005, Whitney sold a large portion of its holdings, raising $233 million.

In the case of Ignite, JH Whitney’s rush to get liquidity in the stock means it may have come public a bit before it actually was ready to be an answerable public company.

Ignite still lists 4 material weaknesses in its internal accounting controls. Previous weaknesses resulted in Ignite restating 3 years worth of financial statements just after the company came public. This caused a 25% plunge in the share price and resulted in lawsuits against the company and their underwriter for making material misstatements in the IPO.

It is somewhat surprising that the weaknesses have still not been remedied even 15 months after the IPO. Instead, the company has taken a JOBS Act exemption which allows it to continue operating with material weaknesses in internal controls. Under normal circumstances, this would be bad enough. But with Ignite trying to integrate a major acquisition of a very challenged and sprawling brand, this is almost a perfect formula for yet another restatement.

Conclusion

Right now is a great time for consumers who wish to eat out cheaply. Restaurants are aggressively competing on price to combat a sector-wide slowdown in traffic. These restaurants have demonstrated that they are more than willing to incur substantial losses in an attempt to maintain traffic. We have already seen earnings disappointments in 5 out of 6 reporting restaurants. Share prices have dropped accordingly. So what turns out to be great for consumers is in fact quite challenging to these restaurant groups.

Ignite is a far weaker restaurant group than most of its peers. The company’s balance sheet is very weak with just $1 million in cash and a deep current account deficit. The company has reported losses in two of the past three quarters. Last quarter began to feel the impact of the continued slowdown in the Macaroni Grill. Efforts to stem the decline are already proving to be very expensive but with minimal results. Management clearly has its hands very full in trying to integrate this large acquisition, such that ineffective internal controls have still not been remedied after 15 months.

Ignite and several analysts have already given us a very clear view about what to expect this quarter in terms of the restaurant slowdown and the impact on revenues and earnings. By trying to launch an expensive turnaround during a restaurant slowdown, Ignite is likely to exacerbate these difficulties substantially.

As a result, no one should be even remotely surprised when Ignite reports a much larger loss than last quarter. Shares should be expected to correct by around 30% to around $11-12 following earnings.

Disclosure: I am short IRG. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

 

Kandi: The truth hurts

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As I mentioned in my last article, Kandi Technologies (KNDI) recently soared from around $5.00 to a lifetime high of $9.20 in the span of just 8 days. Just like in June, this monumental lift off came as the result of a single press release from Kandi and several promotional articles from individuals who are long the stock.

As has been the case in every instance in Kandi’s past, these gains have not held. Kandi has now declined 5 days in a row to $7.10, a very rapid decline of 23% from that recent high just days ago. Yesterday the stock closed near the day’s low of $7.02. If this rate of decline continues, then Kandi will be below $5.50 by the end of next week.

It is clear that many investors who are active in Kandi have derived the vast majority of their information from a series of highly bullish articles and from a private Yahoo message board which was created specifically by those who promote Kandi. The information presented seems to gain credibility because it appears to come from multiple independent sources.

Unfortunately, much of the information which has been disseminated on Kandi (and which has made the price soar) is 100% factually incorrect. Once again, as investors come to realize that they have invested based on inaccurate information, the stock will certainly erase its gains and go back below $5.00 once again.

The most recent example was the article published by Harris Goldman, entitled “As China Goes, So Goes Kandi”. His article has since been removed from Seeking Alpha. Fortunately, references to his comments can still be found in my last article.

The Goldman article does not appear to be the only bull piece that contains substantial inaccuracies which have boosted the share price. Going forward, I will be releasing a series of corrections to a number of very significant factual inaccuracies which have boosted Kandi’s share price in recent articles. This work is already in progress.

Unfortunately I did not save a PDF hard copy of the Goldman article, so we do not have a full permanent record of the line by line comments. However, I have now downloaded and saved copies of all remaining articles relating to Kandi so as to preserve a permanent record in the future

To be specific, Kandi bulls have misled readers about numerous things including: Kandi’s manufacturing capabilities, Kandi’s competitors, the current market demand for EVs in China and the impact of government subsidies.

On the day before the publication of the Goldman article, Kandi had traded as low as $6.60. On the day of his article, the stock rose as high as $8.60. Within 2 days, the stock hit its all time high of $9.20. This was a rise of nearly 40% in just 2 days, based off of a single article.

There is a very clear reason why the Goldman article (as with some of the others) moved the stock. Mr. Goldman made it clear that Kandi is the ONLY company which has mass capabilities and that NO ONE other than Kandi in China can compete http://gulfcoastretirement.org/admin/generic/ on this type of price and volume. Mr. Goldman had incorrectly noted that Kandi already has capacity of 100,000 vehicles which will increase to 300,000.

If any of this were true, Kandi would have certainly deserved a bump up in its share price. In fact, it might actually lend some credence to the notion that Kandi is “the Tesla of China“. Unfortunately none of these statements are correct.

Fact: The EV market in China suffers from too much capacity and too little demand

The Kandi bulls have promoted the view that Kandi is the ONLY competitor in China and that demand is so strong that Kandi will be able to sell everything it can produce.

These statements are both 100% incorrect. There are hundreds of EV manufacturers in China. These are not tiny no-name companies. And they already have greater manufacturing capacity than Kandi. In addition, the prices for their EVs can be seen to be lower than Kandi’s. Their operational specs are basically identical.

In my last article, I included a link to a search on China’s Alibaba portal (in English) which showed these hundreds of competitors. But clearly from the angry emails and comments that have been written, we can see that almost no one even bothered to open the links and read for themselves. Instead, a small number of vocal Kandi bulls simply rejected my findings without even reading them.

I would strongly suggest that readers not simply rely on an interpretation of this list from either me (I am short Kandi) or from Art Porcari (Art is long Kandi). Instead, I would suggest that readers take a small amount of time to evaluate these competitors themselves.

What they will see is that there are many producers of roadworthy and street legal vehicles which derive the vast majority of their sales from entirely within China. Period.

Below is a very brief and partial selection from my Alibaba list, along with their delivery capacities. As we can see, there are numerous manufacturers in China who have greater manufacturing capacities AND lower prices than Kandi. I have included the link to the individual vehicle listings so that viewers can see for themselves that these are mostly identical to Kandi’s cars. Beyond these, there are many more.

 

Name Annual Capacity City Price
Zhangjiagang Haowin New Energy Technology Co. 120,000 Shanghai Inquire at Alibaba
Jinan Qingong International Trade Co. 104,000 Qingdao $6,400-$8,600
Guangfeng Xiaoni Trading Im. And Ex. Co. 96,000 Tianjin $3,500-$4000
Guangdong Yatian Industrial Co. 72,000 Guangzhou $7,000-$7,650
Shandong Bidewen Power Technology Co. 60,000 Qingdao Inquire at Alibaba
Shangdog Shifeng Co. 50,000 Qingdao Inquire at Alibaba
Shandong Wina Green Power Co. 50,000 Shangdong Inquire at Alibaba
Jinan Allied International Trading Co. 30,000 Qingdao $8,000-$9,000

Until my recent article, Kandi’s promoters continued to make the claim that Kandi is the ONLY such manufacturer in China simply because US investors did not know otherwise. Of the EV makers that sell in China almost none of these companies trade on US stock exchanges. The only ones that do (such as BYD and Geely) tend to be Hong Kong listed and trade on the pink sheets. The EV makers in China typically market themselves only in China. As a result, the vast majority of US investors are entirely unaware of the presence of numerous competitors.

But the Kandi promoters have repeatedly claimed to have performed countless hours of “due diligence” over the span of multiple years. The words “due diligence” appear numerous times throughout their articles as assurance to readers about the thoroughness of their work.

Yet the information on competitors is easy to find for anyone who looks.

Author Tom Konrad (who was long the stock) lost a number of friends when he expressed some caution on Kandi. This was true even though he maintained a (reduced) position as a long. Unlike some of the more unrepentant bulls, Tom made sure to highlight the fact that Kandi does have competition from some of the largest EV manufacturers in China. Tom specifically highlighted Chery Automotive, Shandong Shifeng Group, and Hebei Yu Jie Ma. Tom recently noted that he sold his Kandi stock as soon as it hit $7.00.

Point #1: It is inconceivable that such thorough “due diligence” from the Kandi perma-bulls would have failed to uncover the existence of hundreds of nearly identical competitors who have massive production capacity in China. Yet until my last article, these facts were denied.

Point #2: The claim that Kandi is somehow unique (“the Tesla of China”) is therefore based on information that is 100% inaccurate. Yet this inaccurate claim has now been made dozens of times.

Clearly the points above illustrate that there supply of EVs is far greater in China than the Kandi bulls have stated. But of equal importance, it is also the case that demand is far lower than the bulls have stated.

We can see that many of the bull arguments posted include the fact that China has targeted 500,000 EVs by 2015 and 5 million by 2020. Some have cited the “10 Cities and 1,000 Vehicles” program which has been promoting EVs via subsidies in 25 cities (including HangZhou). This program which includes subsidies has been in place since 2009.

The Kandi promoters have emphasized these impressive facts to indicate that there will be tremendous demand for EVs in China. This information, coupled with the incorrect information that only Kandi can supply them, has led investors to the conclusion that Kandi will soon be worth a tremendous fortune. People who read the bullish articles on these subjects, but who fail to do their own research, are then fully convinced. When the articles come from multiple authors, it lends even greater credibility.

But the reality for Kandi and for the EV market in China is far different than what is being consistently preached by the Kandi promoters. In fact, the reality is entirely consistent with the results we see from Kandi’s financial statements. It is also consistent with the share price reactions we have seen from the few Chinese EV makers who trade on foreign exchanges. It is also quite consistent with the unanimous view expressed by independent media channels and Chinese automotive experts.

The only people telling us otherwise are a small number of individuals who happen to own Kandi stock.

In July of 2013 (just 3 months ago), the WorldWatch institute put out a research piece entitled: “China’s Electric Vehicle Development Failing to Meet Ambitious Targets”

The report states clearly that

Although these ambitious targets are developed and supported by the central government, they seem overly optimistic and unattainable given the current situation. According to the China Association of Automobile Manufacturers, only about 20,000 new energy vehicles (EVs, hybrid-electric vehicles (HEVs), and PHEVs combined) were sold in 2011 and 2012, meeting only 4 percent of the 2015 target.

The current reality in China is that people aren’t buying electric vehicles simply because they don’t want them. Clearly some of this is related to price. The bulls have stated clearly that the recently announced subsidies will help that.

But the recent subsidies were actually a renewal of subsidies that have been in place for years. During that time, and despite the subsidies, EV sales have been miniscule.

According to a report from McKinsey.

Government-sponsored subsidies have failed to stimulate consumer demand. For example, while EV buyers in Shenzhen were offered some of the highest subsidies in the country (e.g. RMB 120,000 per vehicle for BEV passenger cars), automakers sold only about 600 BEVs there by 2011.

Beijing based Jack Perkowski has over two decades of experience as an expert in China’s auto industry. He formerly ran a joint venture which invested over $100 million in Chinese auto parts JVs. In June 2013, Mr. Perkowski wrote an article in Forbes entitled “The Reality Of Electric Cars In China“.

He notes that:

recent meetings that we have had with most of China’s local car assemblers confirm that none are counting on electric vehicles for any meaningful amount of growth anytime soon…. BYD , the poster child for electric vehicles in China, is also de-emphasizing electric vehicles. … Due to their intellectual appeal, hype for electric vehicles has always gotten ahead of the realities of market demand. In China, this is once again proving to be true.

Quartz.com just put out an article last week in response to the latest Chinese subsidy news entitled “Even the Chinese government can’t command progress on electric cars“.

According to Quartz:

Beijing hasn’t given up on the race to dominate electric cars. But scant sales have turned China away from focusing on wheels on the road right now….About three years ago, the US and China both announced ambitious aims to capture the global electric car market by putting, respectively, 1 million and 500,000 electrified vehicles on their roads by 2015. Today, neither country is on track to reach these numbers-instead, the US has 130,000 electrics andChina a paltry 40,000…. But analysts doubt the renewed subsidies will finally trigger a buying binge

Those who are reading this article can feel free to completely disregard my views. After all, I am short the stock and therefore biased. However…

Point #3 : US investors need to ask themselves why so many independent experts such as Bloomberg, McKinsey, WorldWatch, Perkowski and Quartz, are all so bearish on the EV market in China. Likewise, they need to ask themselves why the only parties who are wildly bullish happen to be a small handful of investors who also happen to own stock in Kandi ?

There are a number of very common sense and logical reasons why EV sales continue to be so poor in China. For these same reasons, most experts do not see a substantial rise in EV sales any time soon.

Because these EV makers have competed on price, the quality of the vehicles is undeniably very low. This should be visible from the pictures of Kandi’s cars which are available on line. The dozens of competing low speed, low priced vehicles are also nearly identical.

The drive train for an electric vehicle is actually fairly pricey. Yet the cost of the whole vehicle is only around $10,000. Readers need to use their common sense to decide if one can actually manufacture a high quality automobile for just a few thousand dollars.

I recently test drove a Kandi vehicle which sold for around $10,000. It was not horrible, but quality was clearly an issue. When I drove it, the glove box kept falling open. The windows are old fashioned crank style windows which do not open easily. The seats vibrate a lot. There is a loud whirring noise when driving. It is not the end of the world. But it is also not a vehicle that many people would likely choose to drive – at any price – if they have any alternative.

But keep in mind that Art Porcari has also test driven a Kandi car and he continues to tell us all that Kandi is set for near term greatness. He is also long the stock and stands to benefit from the rise in its share price.

Kandi, Geely and many other manufacturers have had EVs on the market for years. The “10 Cities” program has been promoting EVs since 2009. Yet in the past two years, a grand total of only 20,000-40,000 vehicles has been sold – by all manufacturers combined ! This is during a time when the subsidies werealready in effect.

The reason why Kandi itself only sells a few hundred of these EVs is because most people are not interested in driving such a low end vehicle. We have already seen that cutting the price does not really boost sales when it is a product that people just don’t want. People need to keep in mind that the vehicles made by Kandi have absolutely nothing in common with a high end vehicle like Tesla.

A separate reason is far more practical. Anyone who has lived in China knows that parking in any major city in China is very similar to trying to park in the middle of Manhattan – or worse. It is extremely difficult and absurdly expensive. This should be intuitive when one considers that the population of Beijing is over 20 million. The population of Shanghai is over 40 million. That means that the population of Shanghai is greater than the entire state of California – crammed into a single city. It is greater than the population of New York, Los Angeles, Chicago, San Francisco Boston and Seattle – combined ! And that is just one city. Likewise, China has dozens of cities with populations greater than 5 million.

What is the point ? The point is that people who can’t afford $10,000 for a car can also not afford to drive or park a car at any price in China. Many US investors are clearly unaware that in a country of 1.6 billion people, the vast majority of people do not live in single family homes with an attached garage. They live in large high rise buildings which do not come with their own garage space. If you gave them an EV for free, they would still have no place to park it. Nowhere !

Those who can afford a home with a garage in China are typically not inclined to buy a noisy low speed vehicle with crank windows and no amenities. Those who cannot afford a garage have no interest in owning a car at all.

These notions are not my opinions. They are facts which are frequently expressed in the Chinese media. One example can be found in an article entitled:

Dying for a Spot: China’s car ownership growth is driving a national parking space shortage

Individual readers can come up with their own explanations for the very poor EV sales. But the fact remains that there has been virtually no demand for low priced, low speed EVs in China from consumers.

I am not saying that Kandi will not sell any vehicles. I am saying the best case scenario is dramatically less than what the Kandi bulls are promoting. It is clear that Kandi and the dozens of other major EV makers will hope to sell the low cost, low speed vehicles to taxi and other public transportation systems.

WorldWatch agrees with this, saying:

As a result, more than 80 percent of the so-called “energy-saving and new-energy vehicles” (EVs, HEVs, PHEVs, fuel cell vehicles, and other energy-saving conventional vehicles)across the 25 pilot cities were purchased for public transportation service rather than private use, showing a weak market demand for these types of vehicles among private consumers.

Likewise, McKinsey shares this view, stating:

In addition, government subsidies and incentive policies have proven to be far more effective at stimulating the purchase of EVs for public fleets than they have been at stimulating private consumer demand.

The HangZhou agreement with Kandi was announced in 2012 but material sales have yet to occur. At some point in time, if material sales actually materialize, this will be a good start for Kandi. Kandi may therefore be able to sell several thousand vehicles over the next few years. But this is categorically different than the predictions of $2 billion in sales from Mr. Goldman or even $100 million in near term sales from Mr. Porcari.

While there may ultimately be demand for even more LSVs from various taxi and public transport companies across China, it must also be remembered that there are potentially hundreds of companies – with massive over capacity in production – who are vying for this same business.

Point #4: Kandi bulls have projected massive sales figures by simply assuming that demand is there for 100% of what Kandi can produce. Yet despite ongoing subsidies and incentives for the past 3 years, only 20,000-40,000 EVs have been sold across all of China by all EV makers combined.

Question: Did Kandi move due to “news” or hype ?

Whenever there is any news which applies to EVs in China, Kandi’s promoters begin trumpeting the development as being a massive catalyst for Kandi’s near term profits and share price. So far this gambit has worked well, and the share price shows sharp jumps (but which only last for a few days).

We saw this sort of hype in June when Kandi announced its inclusion on the MIIT approved vehicle list. The problem with this news is that it applied to hundreds of other vehicle manufacturers and thousands of other models. No other EV manufacturer saw their stock surge even though they were included on this list too. In fact, no one else even bothered to announce this “news” because it was a non-event. Yet Kandi’s share price quickly doubled to $8.50. It was also interesting that the official list had been published in China weeks before Kandi chose to announce it for themselves. Kandi delayed the promotion of this news until it was much closer to issuing $26 million in stock.

This latest “news” in September was that China had codified its subsidies for EVs. Again, this was trumpeted as a major and transformational development for Kandi and the stock soared to $9.20 on the back of Mr. Goldman’s article. As was the case in June, this news was released over a week earlier. Kandi did not put out a pres release on the subject until immediately before filing a S3 covering the sale of over 1 million warrants which would raise $5 million for Kandi.

As was the case in June, the September news applied to the entire EV market in China. Of greater importance is the fact that these were not new subsidies at all, but instead were just a renewal of past subsides. And in sharp contrast to the analysis from Kandi promoters (who own Kandi stock), independent media suggested that the news was not so great.

So what does the independent media have to say about the latest “news” ?

Bloomberg offered the following commentary on September 17th, following the announcement of the subsidies:

The new policy is basically the same as the previous one and doesn’t really address the underlying problems,” Han Weiqi, an analyst with CSC International Holdings Ltd. in Shanghai, said yesterday in a phone interview. “Unless there are follow-up measures to step up support for hybrids, today’s policy is not expected to spur the EV market.

A new subsidy plan has been long awaited,” Ole Hui, Hong Kong-based analyst at Mizuho Financial Group Inc. (8411), wrote in a report today. “This new plans seems less aggressive than earlier targets.

So how did the share prices of other EV makers respond to the news ? They certainly did not shoot up by 50% like Kandi did. Following the release of the subsidy news, Bloomberg noted that:

BYD Co. (1211), the maker of electric vehicles that counts Warren Buffett‘sBerkshire Hathaway Inc. (BRK/A) as a shareholder, fell as much as 3 percent as of 11:12 a.m. in Hong Kong trading.SAIC Motor Corp. (600104), which began offering its Roewe E50 electric car in November, slid as much as 1.4 percent in Shanghai.

But for the Kandi bulls, the recent “news” of Chinese subsidies was to be transformational and would send Kandi into the stratosphere.

What is the point of this ? The point is that the facts being conveyed by a small number of vocal Kandi bulls (who happen to own the stock) is wildly at odds with view being expressed by the mainstream media, including Bloomberg, McKinsey, WorldWatch and many others. The movements in the share prices of other EV makers seems to agree with Bloomberg. Only Kandi has soared to new highs. But this sharp rise has been based on the analysis and interpretation of this small group of individuals who profit from gains in Kandi’s stock.

Point #5: Even when news has been neutral or negative, Kandi bulls have used any mention of EVs in China to proclaim a new, transformational tipping point for the stock. This has consistently been at odds with the views of independent media sources and the share price reactions of the few publicly traded Chinese EV makers.

Conclusion

There are several realities that we must deal with in looking at Kandi.

The first reality: there are a large number of investors who simply do not even care if Kandi has a bright and legitimate future or not. They simply know that these hyper bullish articles have consistently been able to provide the stock with a sharp (but brief) boost. They are happy to buy and make a quick and easy profit. But they have no intention of waiting around to see if the hype is real. As a result, they quickly sell to lock in quick profits. This is why Kandi has repeatedly given up its gains on each surge in 2013.

It can be easily seen on comments below articles and on message boards that various investors are now counting much more on a continuing stream of bullish articles to pump up the share price than they are on any actual progress from Kandi itself. This is a very bad sign for any stock.

The second reality: The information which has been used to promote Kandi’s share price has often been 100% incorrect. Kandi is NOT the ONLY supplier of EVs in China, there are hundreds of identical offerings. Demand for EVs is not astronomical. It is not even merely substantial. The extremely and persistently low levels of demand have been cause for concern in various independent articles and industry reports. Likewise, the latest “news” regarding the EV industry and subsidies in China has been negative and has seen share prices of other Chinese EV makers fall rather than skyrocket. Analysis by independent media sources (who do not happen to own Kandi stock) have been unanimous on this front.

But because the numerous other EV competitors in China are unknown in the US, many US investors have come to believe that this inaccurate information is true. The fact that multiple writers have been posting very similar (but inaccurate) information has caused many investors to give this information even greater credence.

The fact remains that many investors who have bid up the price of Kandi by 50-100% have done so based on information which is verifiably 100% incorrect. As they come to appreciate this, the stock will almost certainly correct to below $5.00, from where it began.

The third reality: Kandi bears all the hallmarks of a classic stock promotion. A small number of investors produce well timed and coordinated articles designed to generate maximum enthusiasm for the stock. Much of the information is inaccurate. The promotion is then coordinated with organized buying to elevate the price.

The promoters of Kandi have then set very lofty share price targets which are often several hundred percent above the current level.

But readers need to ask themselves this: if Kandi is destined to rise to $30-50 in the near future, then why is there such a desperate need to continue pumping the stock when it gets down to $5.00 ? Why is there such a desperate need to defend the stock as soon as it falls by as little as 50 cents ?

If the share price were really headed to $30-50, then the right strategy would be to simply turn off ones computer and ignore the stock for the next 6-12 months. One could simply ignore arguments like mine because they would truly have no impact on the share price 6 months from now. These gyrations would be just random noise over the period of a few months.

The determination by the promoters to get the share price up basically tells us that they do not have the confidence in Kandi that they claim. Their rabid concern over the share price can only be explained by assuming that they are looking to sell in the near term and at prices not far above current levels.

Clearly the only thing that would really propel Kandi to such lofty levels would be actual success on the commercial front. But the steady stream of articles designed to pump up the share price has continued anyway. And now, we are told to expect a full promotional video produced by a professionally hired video production team. Once again, if the stock is inevitably headed for $30, then such a promo video would not be necessary. Nor would it have any marginal impact relative to the triple digit gains which are expected.

The good news is that for those who really believe that Kandi is truly destined for near term greatness, detailed findings like these really don’t matter. Investors who feel this way should simply disregard this article and not even watch the share price.

Disclosure: I am short KNDI. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

Biolase plunges on liquidity concerns

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On Wednesday August 7th, Biolase Inc (BIOLannounced Q2 results. The company missed analyst estimates by 2 cents and updated investors with guidance at the lower end of previously given ranges.

Missing earnings is never a good thing. But as earnings misses go, this one was certainly not catastrophic. Despite the moderate nature of the miss, shares of Biolase began to plunge in the days that followed. The shares have now fallen by 50% in the week since earnings. The shares have not traded up on a single day since earnings. Clearly something bigger is going on.

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As shown below, further steep declines in Biolase are highly likely in the next few days due to the need to issue a large amount of equity, regardless of the price.

The company’s $30 million S3 registration statement should be effective within days, at which time the offering can proceed. Biolase is in a position where it simply must complete an offering, such that even if the price falls to $1.00 or below, the offering must still proceed.

What has happened is that details given in the 10Q and the earnings call have revealed that Biolase is now in the middle of a near term solvency crisis. Yesterday, as the stock was hitting $1.80 (down 50% since earnings), Biolase put out a brief press release, repeating what it had already stated in the recent 10Q, that Comerica Bank had waived Biolase’s non-compliance until September. But, as expected, the stock price was not cheered and continued to fall 7% further that day. Following the press release, Biolase closed at $1.81, a new low for the year.

As confirmed in the press release, Biolase is now in violation of its bank covenants. It has around 19 more trading days in which to rectify this situation before the Comerica deadline. Biolase has already given weak guidance for the remainder of the year such that any turnaround in financial performance will not be able to repair the situation with Comerica.

The only way for Biolase to repair the situation with its lender will be to issue a substantial amount of stock at whatever price the market will bear within the next 19 trading days. Biolase knew that this situation was coming, so they filed a $30 million S3 registration statement just a few days before earnings. Had the S3 been effective, Biolase would presumably have already issued stock immediately.

On the conference call Biolase specifically highlighted the filing of the S3 as its source of liquidity when discussing its low cash balance and the situation with its credit facility. As a result, there should be very little uncertainty with respect to the company’s intentions about issuing stock.

The $30 million S3 was filed on July 26th. Yesterday (after the close) Biolase filed the amended S3 which included reference to the latest 10Q and the latest share price. It confirmed a maximum size of $30 million. There were no other changes of substance. As a result, the S3 should be effective within a matter of days.

At that time Biolase will need to issue stock almost immediately. The biggest threat to Biolase is now that the stock will continue to fall before the offering can be completed. Either way, once the S3 is effective, we can expect a very quick offering by Biolase which will likely come with a discount of at least 20%. Given the distressed nature of the company at present, the offering will likely require additional issuance of warrants.

The market has already figured this out. This is the reason for the continuing plunge in the share price.

It doesn’t matter where the stock appears to stabilize, investors always become aware that a further drop is guaranteed because of the need to issue stock at any price. Hence, the selling continues.

Biolase has not risen on a single day since releasing earnings.

Certainly Brecken Capital saw this coming. The fund had previously owned around 9% of Biolase but began selling down its holdings following disappointing Q1 results. As soon as the S3 was filed, Brecken reduced its stake to exactly 4.99% which allows it to sell further without making any disclosures. Had Brecken attempted to dump larger amounts of stock earlier, the reported sales would have spooked other investors making additional sales difficult for Brecken. Instead, Brecken conducted a very smart stealth exit from Biolase.

Everyone knows that an offering is coming. Everyone also knows that the discount on the offering will be very large due to Biolase’s distressed financial condition. This has created a viscous circle of selling.

Now there is the additional problem that as Biolase’s share price continues to fall, the market cap is now getting dangerously low. There becomes the very real risk that Biolase will be forced to issue substantial amounts of stock at prices below $1.00. But at those prices, Biolase would struggle to raise a sufficient amount of money to satisfy the bank while continuing to run its business.

On its recent conference call, Biolase management disclosed that revenues were 7-10% lower than internal goals for the quarter. Gross margin fell from 55% to 39%. The net loss grew to $2.6 million. Cash balance has now fallen to just $2 million and management disclosed that the company will not generate cash flow for the year.

Total stockholders equity has now fallen to just $8 million. Meanwhile Biolase owes at least $6 million to Comerica.

According to the credit agreements, Comerica has the right to declare all amount outstanding to be immediately repayable in the event of a default. Biolase is now in default due to its failure to maintain $500,000 of EBITDA. But clearly Biolase does not have the money to repay Comerica.

As a result, Comerica had no choice but to waive the default for Biolase for several weeks. As an initial move, Comerica did begin curtailing credit to Biolase to restrict any future borrowing. The credit facility has just beenreduced from $10 million to $7.5 million.

Often times there are creative ways for distressed companies to gain some additional traction with their lenders during hard times. Unfortunately, Biolase appears to have already exhausted all of these extreme measures.

The receivables have already been placed in a “lock box“, such that Biolase cannot touch any of the proceeds from these sales until Comerica first receives the money and services the debt.

Next, substantially all of the assets of Biolase have been pledged. This is not just assets which are presently owned, but also against any assets which may be acquired in the future.

As disclosed by Biolase

Lockbox arrangements under the revolving bank facilities provide that substantially all of the income generated is deposited directly into lockbox accounts and then swept into cash management accounts for the benefit of Comerica Bank. Cash is disbursed from Comerica Bank to the Company only after payment of the applicable debt service and principal. At June 30, 2013 and December 31, 2012, there were no restricted cash amounts. The Company’s obligations are generally secured by substantially all of the Company’s assets now owned or hereinafter acquired.

Also disclosed was that Biolase issued 80,000 warrants to Comerica with a strike price of $2.00. This warrant would have been an incentive payment from Biolase to Comerica. The warrant was issued in 2012 and was fully exercised by Comerica in 1Q2013. The issuance of stock warrants to maintain a lending relationship with a bank is a very unique occurrence. But the issue is that stock and warrants are the only currency that Biolase can currently make use of.

What we can see is that anything resembling an asset has already been given to the bank as security. There is nothing left to give. When assets ran out, Biolase began giving the bank warrants on its stock. But with the share price is a tailspin below $2.00, there is little value left to be given to the bank.

As a result, Biolase has no choice but to issue equity at any price, regardless of how low.

How did we get here ?

Biolase has been in business for nearly 20 years but has consistently failed to generate profits.

After years of consistent losses, investors and analysts were cheered in March, when Biolase released Q4 results. In Q4 Biolase reported a rise in revenue and a very rare profit. The hope was that after decades, Biolase might finally be turning the corner. The shares rose to a multi year high of over $6.00, up from just $1.50 last year.

This hope was darkened when a disappointing Q1 was reported (including a resumption of net losses and a dangerous drop in cash). The shares quickly fell to below $4.00.

Q2 results the smashed all hopes completely. It was another money losing quarter along with discouraging guidance. Within days the stock was trading below $2.00 again.

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The ongoing net losses have been a notable drain on cash. Biolase has not shown any positive cash flow from operations in the past 4 years. The only source of cash which has carried Biolase through up until now has been the proceeds of its $18 million equity offering competed two years ago.

Over the course of the past year, there have been numerous headlines detailing Biolase’s progress with various patent and partnership initiatives. This lasers for Ear, Nose and Throat (“ENT”), eye conditions such asGlaucoma, and the NewTom oral imaging product.

It may be the case that over coming years, one or more of these products might start to become a meaningful contributor to recurring revenue. However investors have largely learned to tune out these announcements until they produce real results.

As shown in its recent presentation, Biolase already has 352 patents on various new products issued and pending. Over 70% of these are related to WaterLase technology. Yet despite the progress on hundreds of patents over the past few years, there has been very little translation into recurring revenues. This is why investors have largely tuned out the similar announcements during 2013.

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Biolase has already put out guidance that it hopes to achieve approximately $68 million in revenues for 2013. This is the low end of what had previously been announced. This would be an improvement over 2012, but would still only put Biolase back on track with the revenues it had achieved in 2006. Biolase has not given guidance for when we would expect to see quarterly profits instead of quarterly losses.

When explaining the difficult Q2 results, Biolase offered a laundry list ofexcuses, including:

- disappointments in Germany

- delivery delays from Europe

- flooding in Canada

- non approval from Health Canada of Epic 10

- generic problems with Obama care

- rising interest rates

Basically, anything that could possibly go badly did go badly. But this has been consistent for years now. This was not an unusual quarter for Biolase.

In reality, management used incredibly poor judgment in waiting to issue equity. In Q1 the cash balance was already down to $1 million, such that the need for an offering should have been very clear. The share price had traded as high as $6.00, meaning that over $20 million could have been raised at a very attractive price. This would have given Biolase complete freedom to run its business for the next year or two without any cash constraints.

Instead, management waited until the cash was desperately needed. This has created a self fulfilling prophecy of a plunging share price and created significant uncertainty as to whether or not Biolase can raise enough money to satisfy the bank and keep funding operating expenses.

Near term investment thesis

In the near term, solvency concerns and the need to issue stock will entirely control Biolase’s share price. Biolase will be forced to issue up to $20 million of stock. If the stock price can hold up for a few more days then Biolase may be able to issue stock at around $1.40-1.50. But if the stock continues to fall then the offering price could start to approach $1.00. This is an urgent financing for Biolase and therefore the offering should be expected as soon as the S3 becomes effective. This could easily occur within the next few days.

Company background and investment considerations

The corporate predecessor of Biolase was Societe Endo Technic, SA an endodontic and laser product company founded in 1984 in Marseilles, France. In 1994 the company changed its name to Biolase and in 1998 the company adopted the focus it maintains today, developing, manufacturing, and marketing lasers for applications primarily in dentistry as well as dental imaging equipment.

The most important segment of the company’s business is its lasers. Biolase has two categories of lasers, Waterlase, its flagship product, and Diode. Using patented technology, Waterlase combines water and laser energy to perform procedures that would otherwise require dental drills, scalpels, and other traditional cutting instruments. Diode is used to perform less invasive procedures such as pain therapy and teeth whitening. Biolase has 160 issued and 150 pending patents for its laser technologies.

As the company’s flagship product, Waterlase is the most important part of Biolase’s strategy. The key selling points of Waterlase are that compared to traditional methods it reduces pain while improving the safety of dental procedures. Biolase also claims that Waterlase has an advantage because it may be used on both hard (anything involving teeth and/or bone) and soft tissue, something that is not available in other technologies.

Biolase cites the 2007 American Dental Association Survey of Dental Services Rendered ( the “ADA Study”) indicating that more than 200 million hard tissue dental procedures are performed annually in the United States alone. The existing technologies that are currently being used for the vast majority of these procedures are high speed drills for hard tissue (preparing cavities for filling, root canals) and cutting instruments for soft tissue (reshaping gum lines and related procedures).

High speed drills can be problematic because their forces may damage the patient’s dental structure, potentially even causing the patient to need another procedure. Also, drills obviously require anesthesia, and because it is not recommended to anesthetize more than half of the mouth at once, a patient may have to return for multiple procedures if drilling is required in many different parts of the mouth. Finally, the tools used in these procedures can potentially pose risk of infection to patients. According to Biolase, 15 % of dental burs carry “pathogenic microorganisms” which may infect a patient. Cutting tools used on soft tissue don’t appear to be nearly as problematic, but Biolase claims that the discomfort and bleeding are problematic compared to the reduced difficulties that result from use of its lasers. As stated above, Waterlase precisely cut hard and soft tissue with “little or no” damage to surrounding tissue.

While reduced discomfort and tissue damage is obviously a key benefit for patients, the benefits for dentists are at least as important as they are the decision makers.

The company believes that dentists benefit from using its products because of the additional procedures that may be performed using Waterlase that would not be available to dentists with traditional tools. This gives the dentist an opportunity to increase his or her revenue. Biolase also believes that the reduced discomfort provided by its lasers may increase the patient base for dentists who use them, and that the reduced number of post-operative complications that result from reduced surrounding tissue damage will be an important benefit as well.

The company admits that currently only a small percentage of dentists use lasers, and that they are more expensive than traditional tools. Biolase is clearly hoping that its products are in fact superior to the degree it believes, and that as a result its lackluster sales growth thus far will be replaced by more impressive performance. With all this in mind, Biolase is optimistic on the market demand for flagship Waterlase as well as Diode and its other products. However, its important to note that these products have already received FDA approval and have therefore already been exposed significantly to the market, meaning that much of the growth is already factored in with current market acceptance.

Of secondary importance in the company’s product line is dental imaging equipment. Biolase also has three main products in this category, the DaVinci Imaging, Cefla NewTom, and Trios intra-oral CAD/CAM. These systems provide an advantage over traditional technology because they are capable of providing three dimensional images as well as color and higher quality. They also have no time delay. Similarly to the lasers, these provide an advantage to dentists because they may increase the range of possible procedures as images that provide more information due to their more detailed and three dimensional nature may detect problems that would otherwise go undetected for longer periods of time.

Disclosure: I am short BIOL. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

STON: A Ponzi dividend set to end

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In July 2012, the Whiting USA Trust (WHX) was trading at $18.00 and had just paid one of its highest ever dividends. Whiting had long been subject to heavy criticism due to the unsustainable nature of its dividends which were based on finite oil and gas reserves. Each time a negative article surfaced, the retail investor base shrugged it off or refuted the concerns of the critics. It was notable that institutions and insiders refused to own Whiting. It was almost entirely held by mom and pop retail investors for its dividend yield of at least 10%.

On July 17th, 2012, Seeking Alpha author Shane Blackmon published an article entitled

You’ll Lose 50% Of Your Money If You Hold This Trust For The Next 3 Years

In fact, it did not take 3 years for the stock to fall 50%. By the end of that very day, the shares closed down by 50%.

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The majority of investors had already been made aware that the dividend at Whiting was fundamentally unsustainable in various articles and comments. However, each person was individually certain that they could keep collecting the dividend for the short term, and then exit before the price imploded.

On July 17th, 2012, they found out the hard way that it is impossible to time the implosion of an unsustainable dividend scheme.

Shares of Whiting never recovered, and are now down by more than 70% from their pre-article price. Whiting now trades for below $5.00.

StoneMor Partners (STON) is in a different business than Whiting, but in many respects the problems are identical to those of Whiting.

The stock is often not particularly liquid, however there are very cheap call and put options listed at very frequent strike prices.

Investors should be particularly concerned that institutions and insiders absolutely refuse to own StoneMor, just as they did with Whiting.

Investors should also be concerned about the steady stream of warnings that StoneMor’s dividend is an unsustainable “Ponzi dividend”.

Ultimately we will see that current investors in StoneMor are set to lose around 30-50% relative to the current price. The only catalyst that is necessary is when others decide to sell. This could happen either before the dividend is cut or after.

The reason for this is that the dividend is in no way sustainable. As with Whiting, some investors are already aware of this, but choose to keep collecting the dividend in hopes they can get out before the big drop in the share price.

With Whiting, there was no fundamental change or announcement that led to the 50% drop. Instead it was just that on that day investors chose to stop bearing the risk of the dividend cut and get out. Ultimately the dividend was cut well after the drop in the price of Whiting.

On the surface, StoneMor has all the hallmarks of an ideal retirement portfolio dividend stock. Revenues are stable. The industry is set for continued growth due to the aging of the US population. Gross margins are stable, even though the company does continue to lose money every quarter at the bottom line.

But the biggest attraction of StoneMor is clearly its large and stable dividend of 8-10%. It is the dividend that has made StoneMor a darling among retail investors. Hunger for this dividend has pushed the shares up to over $26, its highest levels since 2011. Many retail investors now seem to regard it as almost a fixed income investment due to these characteristics.

But that is where the good news ends.

The problem with StoneMor is that the “principal” here is far from protected and the yield is far from guaranteed. Despite the low volatility in recent months, regarding this equity as a fixed income security is a dangerous mistake.

Even a cursory analysis reveals significant problems at StoneMor, which indicate that this dividend (and thus the equity price) should be at significant risk. Because the valuation of StoneMor’s equity is entirely dependent upon the dividend, any reduction in that dividend will quickly send the stock down by 30-50%.

We can see that StoneMor has been panned by insiders, institutions, equity analysts and debt analysts. This leaves just passive retail owning more than 90% of the stock.

Now that StoneMor has gone ex-dividend (August 1st), the best move for holders of StoneMor is to take the dividend and run, selling the units.

There has been an abundance of articles which continue to praise StoneMor as an attractive dividend investment. These articles are typically very brief and perform no analysis other than citing the cosmetically attractive dividend along with the attractive fundamentals of the industry. These articles do nothing to assess whether or not StoneMor can actually keep paying this dividend. They also do nothing to explain why this stock continues to have a dividend yield that is several hundred percent above its peers.

This was also the case with Whiting before its collapse. Brief articles noted a high dividend, but failed to test whether or not the dividend could be sustained.

There are numerous red flags which show that the dividend and the unit price are at significant risk with StoneMor. Many of these red flags should be too obvious to ignore.

Each of these red flags is a separate way of noting that the market is telling us it expects a dividend cut. These are the clues from which we can predict the 30-50% downside move.

Red Flag #1: Institutions refuse to own StoneMor

Retail is not the only one who loves dividends. Institutions are big fans of stable dividends as well. Yet total institutional ownership stands at just 9%.

As with Whiting, the institutions are well aware of the unsustainable nature of the dividend at StoneMor. They are also aware that purchasing StoneMor simply for the dividend is a devil’s bargain. As soon as the dividend level is reduced (or as soon as confidence fades in advance), the equity price will fall by far more than the amount of any hoped for dividends.

Red Flag #2: Company insiders refuse to own StoneMor

If the industry is growing and the company is thriving, one would presume that insiders would be eager to lock in an 8-10% dividend as well. Yet the combined total of insider ownership between a dozen different individuals stands at just 3%.

As with institutions, the insiders are well aware that the 8-10% dividend policy is unsustainable. As with Whiting, insider ownership is negligible.

Red Flag #3: Rating agencies have ranked StoneMor as a junk credit

StoneMor equity is not a fixed income security. Neither the dividend payments nor the principal amount invested come with any guarantee. But by looking at the actual debt of StoneMor (which does come with a guaranteed payment of principal and interest), we can see just how risky the equity proposition is.

Despite the stable industry characteristics and the consistent revenues, bothMoodys and S&P rate StoneMor as a junk credit. The current rating of B- is just one notch above being a near uninvestable CCC credit.

S&P had noted an expected recovery value rating of 4, indicating that in an event of default only 30-50% of principal would be recovered.

Both rating agencies express concern that StoneMor is so highly leveraged.

Reasons for rating StoneMor so poorly are explicitly due to the fact that during its entire life StoneMor has never generated enough cash flow to pay its dividend. StoneMor is either borrowing new money or issuing equity to pay these dividends.

The agencies describe this as “negative discretionary cash flow”.

This is the definition of “Ponzi finance”. StoneMor is paying an attractive current return to entice current investors. But the only source of this return comes from the new investment by future investors. Without a constant supply of new investors, StoneMor has no possible way of paying this dividend.

This is a practice which everyone should recognize is dangerous and unsustainable. It always comes to an end. And when it ends, it always ends badly.

S&P previously noted this concern explicitly when putting a junk rating on StoneMor by saying,”Our ratings primarily reflect our opinion that StoneMor’s business model,growth strategies, and ownership structure will result in negative discretionary cash flow that will require ongoing external funding.” S&P added, “In our view, the company’s financial risk profile is ‘highly leveraged’ (as defined in our criteria), primarily reflecting slim operating cash flow.”

But in expressing their opinions, Moody’s and S&P are talking about the risks to debt holders, not to equity holders. The risk to the equity holders is clearly far greater than that of the debt holders, particularly the risk of near term price declines.

Red Flag #4: Clear financial warnings from equity analysts

Surveys such as Valueline and Morningstar continue to highlight warnings on StoneMor.

Valueline continues to rank StoneMor at near its lowest ratings for financial strength, safety and timeliness.

Morningstar continues to rank StoneMor as a “D” for Growth and as an “F” for profitability.

Yet despite these unpromising financial conditions, StoneMor continues to pay out a huge and unsustainable dividend which it finances using new investors.

Red Flag #5: An uninterrupted history of losses

Over the past 5 years, StoneMor has posted roughly 5% annual growth in revenues. But this has largely been the result of increasing acquisitions. These acquisitions and the accompanying revenue growth have not translated into any profitability whatsoever. Over the past 4 years, annual losses have ranged from $6-14 million.

This is clearly why Morningstar ranks StoneMor an “F’ for profitability.

The cumulative loss so far in 2013 is now over $13 million for the first 6 months.

StoneMor bulls attribute these losses to the nuances of death care accounting, by which revenues are not fully recognized until the services are used (ie. the customer is buried).

But we have now had 9 years since the IPO in 2004 for any of this revenue recognition delay to start catching up. Instead, despite new acquisitions (including in 2012 and 2013), the losses have continued.

Pre-tax losses in 2012 did narrow to $4.8 million from $13.7 million in the previous year. However that trend looks to be short lived. The pre-tax loss in 1Q2013 has already come in at over $3 million for the single quarter. One time items in 2Q 2013 resulted in a loss of $11 million for the quarter.

This means that in the first 6 months of 2013, StoneMor has already lost more than it did for full year 2012.

Red Flag #6: StoneMor is close to breaching debt covenants

As of the latest 10Q from just a few days ago, there is a new risk of breeching covenants on StoneMor’s debt.

StoneMor’s debt covenants require that it not exceed a maximum consolidated leverage ratio of 4.0. As of Q2 that level hit 3.97, so it will take almost nothing further to violate this covenant.

StoneMor is also required to maintain a minimum consolidated debt service coverage ratio of 2.50. The current ratio is 3.22, such that if there is just a1% decline in EBITDA, StoneMor will be in violation of its covenants.

Breeching debt covenants will further restrict StoneMor’s ability to pay the dividend.

From latest 10-Q:

We have two primary debt covenants that are dependent upon our financial results, the consolidated leverage ratio and the consolidated debt service coverage ratio. The consolidated leverage ratio relates to the ratio of Consolidated Funded Indebtedness to Consolidated EBITDA. Our consolidated leverage ratio was 3.97 at June 30, 2013 compared to a maximum allowed ratio of 4.00. The consolidated debt service coverage ratio relates to the ratio of Consolidated EBITDA to Consolidated Debt Service. Our consolidated debt service coverage ratio was 3.22 at June 30, 2013 compared to a minimum allowed ratio of 2.50.

Valuation implications

By looking at comparable death care companies, we can see that StoneMor is drastically overvalued relative to any fundamentals. The sole reason for this overvaluation is hunger for the (unsustainable) dividend by retail investors. Were it not for the dividend, StoneMor would quite obviously be trading at roughly half of the current price.

StoneMor has three publicly traded comparable companies, Service Corporation International (SCI), Stewart Enterprises, Inc. (STEI), and Carriage Services, Inc. (CSV). Due to Service Corporation’s pending acquisition of Stewart Enterprises, it’s best to compare StoneMor to only Service Corporation and Carriage Services.

STON SCI CSV
Market Cap. 559.9 Million 4.0 Billion 322.3 Million
P/Sales 2.3 1.63 1.55
TTM P/E N/A 25.8 27.7
EV/EBITDA 25.2 9.3 11.7
Net Debt/Ebitda 7.4 2.8 5.3
Credit rating B- BB BB
Dividend Yield 9.2% 1.5% 0.7%

Profitability: StoneMor is the only one of these peers that loses money, the other two are actually profitable companies.

Debt (leverage): StoneMor is also far more leveraged than its peers, with a very high Debt/Ebitda ratio of 7.4. This is the leverage concern that was expressed by the rating agencies.

Credit rating: StoneMor is rated 4 notches below its peers by the rating agencies – just one notch above a CCC credit. It two comparables are both rated BB, just 2 notches below investment grade.

Valuation: Despite these drawbacks, StoneMor trades at a substantial pricepremium to its peers. StoneMor’s Price/Sales ratio is roughly 50% higherthan its peers. EV/Ebitda is more than double its peers.

It is quite obvious that the only reason for this drastic valuation discrepancy is the massive difference in dividend yields. While the comps pay out 0.7-1.5% annual dividend yields, StoneMor pays a stunning yield of over 9%.

This is also how we can come to the conclusion that any meaningful cut in the dividend is likely to see the price of StoneMor fall by at least 30-50%.

A closer look at the unsustainable dividend

As shown in the charts below, StoneMor’s dividend has been climbing steadily, even though it has not generated enough cash to pay these dividends in any of the past 4 years. In any given year the shortfall ranges from $14-40 million.

(click to enlarge)

So far in 2013, StoneMor has again paid out nearly $25 million in dividends, despite bringing in only $16 million in OCF.

As a result, in each year, StoneMor has tapped the debt and equity markets. In effect, this means that StoneMor is simply raising money from new investors in order to pay off the existing investors. 

So far in 2013, StoneMor has again already raised around $20 million from new investors, net of its debt repurchase. It has also made use of its credit facility with its banks.

The problem is that the base of investors who need to receive a return keeps growing larger and larger.

(click to enlarge)

Meanwhile, we can see that despite stable revenues, StoneMor continues to be unprofitable every quarter.

(click to enlarge)

Distributions approaching a breaking point

Schemes such as this are always unsustainable. When they suddenly end, it comes without warning.

As the investor base continues to grow, the financing need grows exponentially larger as does the need for finding an ever growing supply of new investors.

StoneMor has been tapping both equity and debt investors in order to continue funding this above market 8-10% dividend.

Part of the problem lies in the fact that insiders and institutions refuse to own StoneMor. In most cases, retail investors either cannot or will not perform the analysis necessary to properly evaluate the security. Instead they just keep cashing their dividend checks and hoping for the best.

In its recent earnings announcement, StoneMor illustrates why retail investors have been overly confident in receiving their dividend even as institutions steer clear.

The earnings release states that

Distributable free cash flow (non-GAAP) for the three-month period ended June 30, 2013 increased to $24.9 million from $13.3 million for the same period last year, an 86.8 % increase.

Hopefully more astute investors will realize that the term “distributable free cash flow” is a fabricated non GAAP measure and specifically does not refer to operating cash flow. It is effectively a made up metric.

For example, the release noted that “distributable free cash flow” in 2Q2012 had been $13.3 million. In reality, OCF that quarter was only $6 million. Against that $6 million in OCF, StoneMor had paid out $12 million in dividends that quarter. As usual, it financed this by issuing debt.

Had StoneMor actually generated that $13.3 million in cash, there would be little to be concerned about when paying a $12 million dividend for the quarter. But instead, we can see clearly that this metric is meaningless as StoneMor still needed to http://www.varley.net/online/ borrow to pay the dividend for which it lacked cash. In reality, StoneMor paid out a dividend which was double what it actually generated in OCF.

It is important to note that this arbitrary non-GAAP “distributable free cash flow” number does not even approximate real cash flow. According to the company, the components of this number include GAAP cash flow, plusadditions for the Merchandise Trust. But as disclosed in the most recent 10Q:

The merchandise trusts are variable interest entities (VIE) for which the Company is the primary beneficiary. The assets held in the merchandise trusts are required to be used to purchase the merchandise to which they relate. If the value of these assets falls below the cost of purchasing such merchandise, the Company may be required to fund this shortfall.

Adding in the value of the Merchandise Trust into this new “distributable free cash flow” metric renders it basically meaningless.

It is notable that StoneMor’s treatment of this “distributable free cash flow” has already been evaluated by the SEC and this view has been rejected. Yet StoneMor continues to disclose this manufactured and arbitrary metric as a way of suggesting that the dividend is in some way sustainable.

The $24.9 million in “distributable free cash flow” for 2Q2013 is a very inspiring number on the surface. But it is misleading in two respects. First, it includes a one time cash benefit of a lawsuit win by StoneMor.

But more importantly, it uses the same flawed methodology to suggest that StoneMor is actually generating cash that it is not.

In reality, StoneMor paid out the largest dividend in its history at nearly $13 million during Q2. Meanwhile, actual operating cash flow stood at just $9 million. So once again, StoneMor paid out around 150% of its OCF as a dividend.

But the impression given by the recent press release is that StoneMor only paid out $13 million while generating $24.9 million. This is simply not the case.

Meanwhile, the share count has now ballooned to over 21 million, up by more than 50% in 4 years. Total debt now stands at $230 million. Interest paid during the first 10 months is already at $10 million.

As the investor base has expanded, each of the new investors becomes “entitled” to the ever expanding payment obligations.

Conclusion

StoneMor continues to be unprofitable and generate insufficient cash flow to pay its dividend. StoneMor continues to tap the debt and equity markets for ever larger sums in order to continue paying an above market dividend. As a result, its share count and debt obligations have continued to expand over the years.

StoneMor’s continued publication of the “distributable free cash flow” has confused some retail investors into believing that the company does have adequate cash flow to pay its huge 9% dividend. However the SEC has already disallowed that methodology for computing cash flow.

Paying out an enormous 9% dividend has now become quite obviously unsustainable. As the investor base continues to expand, the payment obligations expand exponentially creating the need to continually raise ever larger amounts of new money from more and more investors. StoneMor has now disclosed that it is now dangerously close to breaching debt covenants (within 1%).

As with the Whiting Trust, StoneMor is likely to fall by 30-50% as soon as investors decide to exit.

As with Whiting, the catalyst for this move is not dependent upon StoneMor cutting the dividend in advance.

Now that the stock has gone ex-dividend and earnings have been announced, there is simply no reason to continue holding the stock. The best move is to exit and eliminate the 30-50% downside risk before other sellers act first.

Disclosure: I am short STON. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

Implications of Organovo Lawsuit

Gavel

I last wrote about Organovo Holdings (ONVO) on July 24th.  Since my last article, there have been several new developments which further reinforce the short thesis on the stock. The stock has continued to fall as expected.

First, the S3 registration statement for up to $100 million of new shares and/or warrants has now become effective. Some acheter cialis 20mg individuals had previously taken comfort that no offering would be impending because the S3 was not yet effective. It is now the case that Organovo is free to issue up to $100 million of equity securities at any time.

Second, I have uncovered an undisclosed legal action against Organovo by their own investment banker, Spencer Trask Ventures (“STV”). The initial arbitration filing  was submitted on June 27th, when STV demanded compensation which is now valued at around $28 million. Under the terms of the original Placement Agency Agreement, Organovo had agreed to binding arbitration. However, on June 28th, Organovo  filed in New York Civil Supreme Court to attempt to fight the arbitration.

There have now been a flurry of arguments and counterarguments in New York Civil Supreme Court during the monthsof June and July.

One issue is that this may prove to be a significant financialissue for Organovo. But as a totally separate issue, this isalready a significant disclosure problem for Organovo.

None of this has been disclosed to investors, including in theS3 registration statement which just became effective a fewdays ago.

Preliminary points

Before getting into these issues, there are a few preliminarypoints that deserve to be made.

Following my article, Seeking Alpha contributor Jason Napodanowrote a forceful rebuttal to my article. It was his 4th bullisharticle on Organovo in less than 1 year.

In his article, Mr. Napodano makes it clear that the points inmy article are either entirely irrelevant or else downrightinaccurate. The author supports these statements with a mix offacts, opinions and anonymous postings from a Yahoomessage board.

There are now three main issues which investors need toresolve for themselves.

  1. How much (if any) of the 32 million share overhang iscurrently depressing the share price ?
  2. How much (if any) equity is Organovo likely to issue underthe recent S3 registration statement ?
  3. How much (if any) revenue is Organovo likely to generatein the next 1, 5 and 10 years ?

Clearly I disagree with Mr. Napodano on each of these points.

A substantial overhang pressing on the share price from the 32million shares from 2012 is evidenced by the fact thatOrganovo still filed a subsequent prospectus on these shares.Once the overhang is fully removed, there will not be additionalprospectuses.

Organovo is likely to complete a very large financing under the$100 million S3 sooner rather than later. It has been less thanone year since the company deliberately reduced the exerciseprice of the existing $1.00 warrants to just 80 cents in order toget money in the door at that price. We can also see from theSTV lawsuit that Organovo tried to incentivize STV to exerciseby reducing the strike price to just 60 cents. This means thatOrganovo was attempting to issue new shares at a price of just60 cents as recently as February / March.

For revenue, Organovo may have some prospects with liver cellmodules at sometime in 2014. But we have been given noindication of the certainty or the amounts which may beinvolved. The key point here is that the hype surroundingOrganovo is in connection with the 3D printing of humanorgans. Not even the most bullish authors expect to seemanufactured human organ revenues any time in theforeseeable future. Instead, we will continue to see smallamounts of revenue from grants and research collaborations.Historically these have typically been in the range of six figureamounts.

In the meantime, we can see that Organovo has beensuccessful in two areas:

- selling stock to investors at $1.00 (or below)

- elevating its share price to above $6.00

The company has recently been sporting a fully diluted marketcap of nearly half a billion dollars, despite the followingfinancial metrics:

- lifetime revenues of just a few million dollars (coming fromgrants and research)

- non cash assets (including all intellectual property) of lessthan $2 million

Metrics like these do not justify a market cap anywhere nearhalf a billion dollars.

A very small but vocal minority of readers continues to posttheir emotional comments below these articles. However amuch larger (and silent) majority chooses to express theirviews by selling their stock rather than typing up rabidcomments.

Prior to my article, the stock was hitting $7.70 in pre markettrading. Following my article the stock fell to $6.50.

It is now the case that all investors have the benefit of fullinformation from these various articles and comments and theshare price continues to slide rather than recover any lostground. Following his article on Organovo, Mr. Napodano left asubsequent comment stating that he believes that ”fair value”for the stock is around $4.00-5.00 - an additional decline of asmuch as 20% from the current level. In the near term, I wouldagree with this statement, which is why I continue to be shortthe stock. Although any potential equity offering couldpotentially push the share price even lower.

An undisclosed legal action

In its past financings, Organovo used the services of SpencerTrask Ventures for raising what now totals roughly $28 millionin proceeds from stock and warrants. As of March, Organovohad $15 million in cash remaining.

The lead individual involved was Adam K Stern, a ManagingDirector with STV. Mr. Stern also became a Director ofOrganovo.

According to the terms of the Private Placement Agreement,Organovo would pay to STV a cash fee equal to 10% of theproceeds along with ”agent warrants” ($1.00 strike price, 5 yearmaturity) equal to 20% of the stock issuable to investors.There was also an 18 month ”tail” provision allowing foradditional fees to be payable to STV based on subsequentcapital raises. A key point of contention in the current lawsuit isthat it was agreed that STV would be appointed as an exclusiveWarrant Solicitation Agent at least 20 days prior to any noticeof redemption. Organovo agreed to not contact any of theinvestors introduced on STV’s proprietary investor list.

In 2012, Organovo Director Stern left Spencer Trask and wentto Aegis Capital. Shortly thereafter, the arbitration suit statesthat Organovo began the warrant solicitation to raise newmoney from STV customers. But instead of using (or evennotifying) STV, Organovo used Mr. Stern’s new firm, Aegis.

In total, Organovo raised $14.8 million through the warrantexercises. In fact, Organovo lowered the exercise price onwarrants to just 80 cents in order to raise new money at thatlevel.

STV did not find out about any of this until it became publicinformation through Organovo filings.

STV and Organovo are now in a protracted legal battle in whichSTV is demanding the disgorgement (and payment) of $14.8million along with $1.3 million in cash fees and the issuance of2.9 million warrants owed. The warrants alone would currentlybe worth around $12 million. Total consideration is thereforenow in the area of $28 million.

During 2013, and after the warrant transactions conducted viaAegis, Organovo and STV began negotiating a Warrant Agreement which would arrange for payment of compensationto STV. A second draft of the Warrant Agreement was alsoprovided.

On March 1st, Spencer Trask’s attorneys sent an email toOrganovo CEO Keith Murphy rescinding the proposedagreement. A copy of the rescind email can be found here.

Following the rescinding, Organovo still sent small payments toSTV, however these payments totaled just $115,000, instead ofthe much larger sum demanded by STV.

Section 13 of the Placement Agency Agreement states (in ALLCAPS) that any ”dispute, claim or controversy” which arises withrespect to this agreement will be submitted to JudicialArbitration and Mediation Services Inc. (“JAMS”) in the State ofNew York.

STV filed for arbitration on June 27th.

The next day, on June 28th, Organovo filed to fight the movefor arbitration, stating that the Warrant Solicitation Agreementvoided both the compensation earned by STV as well as theneed for arbitration.

As is often the case, many dirty secrets get spilled out inlawsuits. Organovo reveals that it had already agreed to pay toSTV $23 million in exchange for helping Organovo raise just$15 million in proceeds. The need to pay such a fee isstaggering in and of itself.

The lawsuits also reveal that Organovo was willing to lower thestrike price on STV’s warrants to just 60 cents, in order to raiseequity at that level. This was not in the distant past. This was inFebruary / March.

Both of these facts speak loudly to the fact that Organovo hasalways been eager to issue equity at just about any price, nomatter how low. The company has virtually no non-cash assetsand continues to generate only minimal and non-commercialrevenues. So getting money at any price may well be the beststrategy.

But it also reconfirms my suspicion that if the company is eagerto issue substantial equity for just pennies, then it will likely bea very large issuer of equity with the price sitting at just over$5.00. A normal discount for an equity offering like this wouldbe around 20%, meaning that an offering would likely takeplace at around $4.00. The stock price would then reactaccordingly.

Investors now need to ask themselves two very importantquestions:

First, how much of the $28 million in demanded compensationwill Organovo end up paying to Spencer Trask ?

Second, why are investors hearing about a potential $28million legal liability from me, rather than from Organovo in an8K or S3 legal disclosure ?

Reverse mergers in perspective

Commercializing a new product or service in the real world is anarduous and time consuming task. Successes are rare andoften take decades to make themselves evident.

Reverse merger stock promotions, in sharp contrast, are fareasier. It is very simple to achieve 8 and 9 figure fortunes inthe space of just a year or two.

Step one is to acquire the busted shell of a defunct company.Step two is to complete a reverse merger and inject sometoken amount of assets. Step three is to change the name.Step four is to heavily promote the story.

A few years ago, when China was hot, it was possible to create$500 million dollars by simply creating a reverse merger withthe ”China” in the name. Hundreds of these companies wereuplisted to the NYSE and NASDAQ. Before that, when solar washot, there were numerous half billion dollar companies createdjust by having some hint of a solar business. Prior to thatadding ”.com” to a companies name would often create similarvaluations for reverse mergers. But in the end, when thesecompanies failed to produce profits, we saw them ultimatelyplunge to the pennies.

As noted in ”Get Rich or Die Tryin’”, there are two kinds ofinvestors in these promotions. The ”Get Rich” crowd gets inearly at very low prices.

It is important to note that the Get Rich crowd has no intentionof waiting for the product to be an ultimate commercial success.Instead, they cash out when the promotion of the stock andthe story hits a peak.

Many authors (such as Mr. Napodano) have clearly expressedtheir views that the early investors in Organovo have alreadysold their stock - well before any commercial success is evenclose. They had no intention of waiting around for real worldsuccess because they were simply playing a stock promotion -not a product.

I agree that these investors will sell well beforecommercialization. But I also believe that they would be smartenough to wait for the price and liquidity which is provided bythe uplisting. This is why I believe that they are selling now.

Early investors cannot sell unless someone else is doing thebuying. Likewise, investors who buy these stocks should beaware that every time they buy, it is the result of someone elsebeing eager to sell. This is where the Die Tryin’ crowd comes in.

It is well known that institutions tend to steer clear of reversemerger promotions. As a result, reverse mergers rely heavilyon promotion to retail investors.

For example, Organovo has made ample use of a servicecalled RetailInvestorConferences.com.

Retail investors can often take comfort from various sources of”validation” which may not be appropriate.

For example, some investors believe that an uplisting to theNASDAQ or the NYSE is reflective of some sort of judgment onthe investment merits of a stock. This is quite clearly not thecase.

In recent years, there were hundreds of Chinese reversemergers which uplisted to the NYSE and the NASDAQ. It wasultimately uncovered that many of these companies wereempty shell frauds with virtually no assets or employees. Mostof these companies were delisted to the pink sheets just asquickly.

The only point I am trying to make is that an uplisting willimprove liquidity, but does not have any implication for theinvestment merits of a company. Note: I am not making anysuggestion that Organovo is a fraud.

Likewise, many investors assume that obtaining a researchgrant is also validation of the long term potential of acompany. Sometimes this can be the case. But we can also seethat the list of non-productive research grants is very long andvery large.

Examples include a $3 million federal grant to study the gameWorld of Warcraft and a $2.6 million program to teach Chineseprostitutes to drink responsibly.

My point is not to suggest that Organovo’s grants are withoutmerit. Instead, my point is to suggest that obtaining a fewmillion in grant money is a very common occurrence for manycreative ventures in the US.

So far, Organovo has not achieved any meaningful degree ofcommercial success. But the stock promotion has beenextremely successful.

Despite minimal assets and revenues, the company has beenable to briefly exceed half a billion dollars in market cap. Therecent rise briefly put the value of CEO Keith Murphy’s stock atnearly $40 million in a very short time since coming public.

Fortunes like this often take decades to achieve when one isdependent upon the actual commercial success of a product.But with reverse merger stocks, they often take just a year ortwo.

Ultimately, Organovo may end up being the reverse mergerthat transforms the nature of medicine as we know it. If so, itwill end up being worth many billions of dollars.

On the other hand, if Organovo fails, someone will come along,acquire the defunct shell and start over with a new billion dollarreverse merger idea. The name will be changed and so on.

Fortunately we are all able to come to our own investmentconclusions with respect to these divergent potential outcomesand we are all able to act accordingly.

I am short Organovo.

ONVO: Red hot but set to drop

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Organovo (ONVO) is about as hot as any concept stock could ever be right now. It sits right at the crossroads of 3D printing and regenerative biotechnology. In addition, Organovo just uplisted from the OTCBB to the NYSE, further fueling the strong enthusiasm.

Following the uplist, Organovo soared from $3.90 to $8.50, a gain of over 100%. But since then it has been dropping almost daily. By Monday it had fallen 26% to $6.29. However, yesterday the latest issue of Popular Science hit the news stands with a cover story featuring futuristic “bio-printing”. Organovo was mentioned and the stock soared as much as 15% due to the article alone.

The article was clearly good for a predictable trade. It was also welcome relief for investors who were getting tired of seeing their stock give up gains each day. But those who are still left holding are likely walking in front of a moving train.

Popular Science has been a long time source of very interesting and thought provoking topics including flying cars and life on Mars. But in stoking the imagination, it tends to ignore many of the practicalities that these futuristic ideas entail.

With Organovo, we are now seeing a “rush for the exits” from different classes of sellers who are trying to beat each other to hit the sell button. With over $300 million in stock coming for sale, this will easily take the stock back to $4-$5 very quickly.

Overall, those who choose to hold shares of Organovo are likely fighting a losing battle which really just comes down to a huge supply of available shares coming for sale which can overwhelm current demand.

No one has a perfect crystal ball to predict where Organovo will be in 10 years time. The stock could be at $30 or it could be at zero.

While the concept is extremely cool, the company is extremely speculative.

Almost all revenues (only a few hundred thousand dollars per quarter) at present are the result of government grants and research collaborations. Revenues from actual product sales are still years away at best. The stock currently boasts a market cap of over $400 million (over $500 million fully diluted), despite having almost no revenues or near term revenue prospects. Against this $500 million valuation, the company has just $15 million in cash. Aside from this, the company has only $1.5 million in total assets. This is truly a “blue sky”, concept stock.

Fortunately, we all have the tools to predict the share price performance in the near term.

A sharp rise upon the uplisting was certainly easy to predict. The company had implemented all of the perfunctory corporate governance and structural measures necessary for an uplisting. Management had also been hinting at it for some time. Anyone who sold before the uplisting was either not paying attention or was just too impatient to wait for this predictable move up. However, the 100% gain was certainly larger than anyone could have predicted.

Now that the uplisting is behind us, a near term drop of at least 20-30% is easy to predict due to the following four very visible sell catalysts:

First, Organovo overshot on its uplisting, doubling from $3.90 to nearly $8.00 on that event alone. Many stocks will see a bump up of around 10-30% upon uplisting due to the improved liquidity that a senior exchange provides. But given that an uplisting involves no fundamental change in the business, any increases of more than 30% are typically very short lived. The 100% gain experienced by Organovo was highly unusual and has already begun to reverse itself.

Second, there is a substantial overhang of 32 million shares (around $200 million) from the sellers who were named in the April prospectus from the Reg D offerings. These investors would certainly not have sold before the uplisting. For anyone who had already been waiting for over a year to sell their stock, waiting an extra few months for the uplisting would be just plain common sense. The stock began its run up after the announcement on July 9th, but has only been on the NYSE for a few days. As a result, there simply has not been enough time for these sellers to complete their selling.

An article in May entitled “Get Rich or Die Tryin’” highlighted this overhang and caused a brief dip in the share price. But the volume that resulted from that article was nowhere near what would have been necessary to clear this number of shares and the price drop was not nearly as steep. So again, it is only sensible to conclude that the majority of holders were waiting for the uplist catalyst in order to sell their shares. The liquidity event that they have been waiting for is happening right now.

It should also be noted that many of the 16 million warrants that are listed in the prospectus would have already been exercised, either voluntarily or due to forced conversion by the company. When the warrants are exercised, the holder is then left with shares which must be sold. So the simple act of exercising the warrant does not remove the overhang. Only selling the underlying shares removes the overhang.

Third, Organovo just filed an S3 registration statement for the sale of $100 million in new shares. The S3 was just filed on July 17th, meaning that it was ready and waiting for the uplisting. By filing immediately after the uplisting, Organovo has signaled its intent to proceed with the offering as quickly as possible, taking full advantage of the strong share price. But with an offering size of around 25% of market cap, this deal will require a discount of around 20%. Relative to the current price, that would price the offering at around $5.50 plus warrants. However, the offering is now competing with the existing Reg D sellers. Any additional selling from the Reg D sellers will mean that Organovo must price its $100 million offering at an even lower level.

Forth, the uplisting has also made Organovo a much easier stock to short. Shorting a stock which just spiked due to its uplisting is often an easy money trade. But when such a stock has as much as $300 million in imminent selling due to two registration statements, it becomes almost too easy for short sellers to pass up. There is ample ammunition to make the stock fall, but there is virtually nothing that could make the stock rise substantially for more than a day or so.

As with the Reg D sellers, short sellers will likely drive the share price lower. This will potentially cause Organovo to price its equity offering below $5.00 if the price dips even slightly.

We can already see that the shorts have been flocking to Organovo as soon as the uplist was complete. The stock was quickly placed on the short sale restriction list due to heavy shorting. Borrowable shares have been snapped up almost as quickly as they become available due to very high demand.

Trading the uplisting

Anyone who follows uplistings should certainly have predicted that this one was coming. An uplisting is actually not a difficult process to undertake. In fact it is entirely mechanical and perfunctory.

Obtaining the original shell on the OTCBB is as easy as completing a reverse merger with a once-defunct company. Organovo completed its reverse merger in a series of transactions in 2011 and 2012.

From there, getting to the NYSE was easy. All that Organovo had to do was implement a board which was comprised mainly of independent directors and then establish three board committees (audit, nominations, compensation). The biggest impediment keeping most issuers from the NYSE or NASDAQ is the market cap and share price restriction. However, the sharp rise in Organovo’s stock this year made the uplisting almost a sure thing.

Organovo’s uplisting was entirely predictable and had been hinted at by the CEO for months. Despite this, the stock quickly doubled.

Investors need to keep in mind that there has been no fundamental change to the actual company which would change its valuation. It is the same company which now simply trades on a more liquid exchange.

In addition, many investors continue to be mistaken in assuming that the uplist implies some type of positive opinion being expressed by the exchange with respect to the company. This is absolutely not the case. Instead, the company simply fulfilled a simple check list of criteria and was then automatically accepted. In the past we have seen hundreds of companies undergo the identical process. A few years ago, it was the case that hundreds of fraudulent Chinese companies became listed on the NYSE and the NASDAQ. When they were ultimately delisted again due to fraud, the NASDAQ and the NYSE were very quick to point out that uplisting does not involve any qualitative assessment on a company’s investment merits.

The key point is that holding Organovo prior to the uplisting was an obvious and easy trade. The uplisting was almost certain to provide a quick boost of 10-30%. But once the share price spiked by 100% with no fundamental developments, selling it is now an even more obvious trade.

The impact of a 32 million share overhang

Back in April, Organovo filed a prospectus which allowed for the sale of 32 million shares of stock by selling stockholders. These shareholders got in at a price of just $1-2 per share around 18 months ago and are now sitting on 3-4 baggers in that time.

Expecting these shareholders to continue to hold such a quick homerun forever is just plain unrealistic. In addition, the timing of the uplist coming just 9 weeks after the prospectus suggests that this was very much a planned liquidity event for these shareholders.

Some may be tempted to think that these shares were already sold following the “Get Rich or Die Tryin’” article in May. This is clearly not the case. That article caused a brief dip in the share price. But the volume only exceeded 1 million shares for two days. Within days of the article, the volume was back down to 200,000-300,000 shares per day – not nearly enough to clear such a huge overhang.

The ability for these holders to eventually sell was entirely made possible by the uplist to the NYSE. Just prior to the uplisting, the stock was trading only around 100,000 shares per day. A full liquidation of 32 million shares would easily have taken months and would have put extreme pressure on the share price.

Now the stock has far greater liquidity and the share price is 100% higher than where it was before the uplist.

Although this is highly beneficial for those who are selling, it will still mean heavy pressure on the share price for those who continue to hold. At current prices, the 32 million shares equates to around $200 million, or roughly 50% of Organovo’s market cap !

Even at prices of around $4.00, this means that many of these holders will still be sitting on 4 baggers. If selling at around $6.00 these holders are locking in quick 6 baggers. The point is that these sellers will likely not be very sensitive to price when locking in their tremendous gains. They have more to lose by waiting than they have to gain.

There has simply not been enough volume to allow for sales of 100% of these shares since the uplisting, which means that we will likely see continued pressure on the share price. We have already seen it dip from a high of $8.50 on Thursday to a low of $6.29 on Tuesday – a very quick retreat of 26%.

Evaluating the $100 million S3 offering

Organovo filed its $100 million S3 shelf registration statement just 1 week after it became listed on the NYSE. The timing of this filing was clearly not a coincidence.

Documents such as this will take the company and its legal counsel weeks to complete. But completing it before the uplisting would have been a waste of time and money because there would be many stock specific sections that would need to be redrafted following the move to a new exchange.

Instead the company clearly had a fully drafted S3 which applied to an uplisted stock even before the uplisting had occurred. They simply waited for the uplisting to take place and then filed the document almost immediately.

Given the price and liquidity before the uplist, launching such an offering at that time would not have been possible.

Offerings such as this can be differentiated between operational offerings and opportunistic offerings. Operational offerings are sized according to specific operational needs which are defined in the “use of proceeds” section. Opportunistic offerings are typically done simply to take advantage of an unusually high share price.

The offering by Organovo is really a combination of the two offering types. It is clear that the company does have an operational need. Losses have ranged anywhere from $10 million to almost $40 million - per quarter ! Yet the company currently has only $9 million in net cash. The company clearly needs to raise at least $30-40 million in the near term.

But the offering size of $100 million clearly reflects a view by the company that the current share price makes NOW the time to raise as much as possible.

This is further confirmed by the defined use of proceeds, which is totally open ended and non-committal:

Except as described in any prospectus supplement and any free writing prospectus in connection with a specific offering, we currently intend to use the net proceeds from the sale of the securities offered under this prospectus for general corporate purposes, including research and development, the development and commercialization of our products, general administrative expenses, license or technology acquisitions, and working capital and capital expenditures.

We may also use the net proceeds to repay any debts and/or invest in or acquire complementary businesses, products or technologies, although we have no current commitments or agreements with respect to any such investments or acquisitions as of the date of this prospectus.

We have not determined the amount of net proceeds to be used specifically for the foregoing purposes.

As a result, our management will have broad discretion in the allocation of the net proceeds and investors will be relying on the judgment of our management regarding the application of the proceeds of any sale of the securities.

Pending use of the net proceeds, we intend to invest the proceeds in short-term, investment-grade, interest-bearing instruments.

This is a very boiler plate use of proceeds definition for companies who wish to complete an opportunistic offering. It basically says “We know that we will need the money sooner or later, so just trust us.” It is also a very clear way of management saying that “at the current share price, we wish to sell every share possible”.

The problem for current investors is that the offering size is extremely large. At nearly 25% of market cap, the $100 million offering will likely require a 15-20% discount from the current share price. The offering is made more difficult given that the stock is almost entirely held by retail investors. A $100 million offering will clearly require the participation of institutions into a stock which has never had institutional interest. This will likely mean the further issuance of a large number of warrants as we have seen in the past.

All in all, if the offering were priced today, it would likely be priced at around $5.50 or below and would include warrant coverage. This would almost certainly send the share price back to around $4.50 in short order.

The problem is that now the company is competing with the Reg D sellers for who gets to sell first. If the stock falls below $6.00 due to Reg D selling, then the company may end up selling at below $4.50 under the S3 and having to include even more warrants.

For those who wish to remain longer term holders of Organovo, there is no reason to hold at a time when the share price is likely to exhibit a predictable decline of 20-30%. It is just as easy to sell now and buy back in at prices below $5.00 again.

Here come the shorts

One of the biggest positives of an uplisting is the fact that liquidity is greatly improved on a senior exchange. This will typically provide a boost to the share price. But it is often overlooked that the uplisting is typically the beginning of meaningful short interest. Once the share price rises, the new wave of shorts can often push it back down significantly.

Shorting OTCBB stocks is often a losing game due to the poor liquidity. As a result, funds who wish to short an OTCBB stock will simply keep it on their watch list and wait until it uplists. This strategy has an added benefit in that it usually becomes possible to short the stock at a noticeably higher level due to the predictable pop upon uplisting. This is exactly what we have seen with Organovo.

This short selling should be expected to create additional downward pressure on the stock at just the time the company is looking to issue stock.

Now there are 3 major competitors all selling stock at the same time: Reg D sellers, short sellers and the company itself with its $100 million S3.

Prior to the uplist, only about 1% of shares were sold short. This is virtually nil. When short interest is already high, any changes in the short will not have a noticeable effect on the share price. But when short interest is going from nothing up to something high, the effect on share price can be pronounced. As a high flying stock with minimal revenues, Organovo could expect to see as much as 25% of shares sold short – around 15 million shares. At a minimum, this will serve to cap further upside in the share price. At a maximum, it could end up driving the share price much lower when combined with the Reg D selling.

Valuation considerations for Organovo

At the present time there is no defensible way to place a fundamental valuation on shares of Organovo. The best we can do is try to predict how certain events will move the stock in one direction or another. The uplisting saw a move up while the flood of shareholder and company selling will knock the stock back down substantially.

Organovo now sports a fully diluted market cap of around half a billion dollars. This market cap will grow considerably larger once the $100 million S3 offering is completed.

Against this, the company has only generated lifetime revenues of a few million dollars. These revenues have primarily been the result of government grants and research collaborations. There have been virtually no meaningful revenues from actual sales of a product. Any material revenues are still years away at best.

As a result, investing in Organovo is largely about investing in a story, not about investing in financials. This is the primary benefit of using a reverse merger to list on the OTCBB.

If Organovo were a private company attempting to tap private equity investors, there is simply no way that these investors would award a half billion dollar valuation to a company which only generates a few hundred thousand dollars per quarter in total revenue.

But the reverse merger-OTCBB-uplist process is both cheap and easy. This allows the company to tap into retail investors who are willing to invest based on a sexy story and based on current market hype for both biotech and 3D printing.

Investors cannot say that they were not warned about the speculative nature of Organovo’s stock. The list of risk factors runs longer than most companies at 13 pages. The company has made it clear that they are working with an unproven emerging technology which may never amount to anything. The have also clearly stated that they will continue raising money and incurring losses for the foreseeable future. This is all part of the norm for this category of speculative “concept stock”. There is simply no foundation upon which to build a traditional valuation framework.

For those who choose to invest in Organovo, it is essentials to keep abreast of any new corporate developments. But of even greater importance is the continuous monitoring of the market for signs of increased or decreased hype surrounding the space. With no real revenues or assets, this stock is affected far more dramatically by sentiment towards the space than it is by actual developments at the company.

Organovo – longer term investment thesis

Organovo is hoping to one day commercialize technology that generates human tissues. The company hopes that its technology could one day generate tissues for use in drug discovery and development, biological research, and therapeutic implants. The previous technologies in the field have relied on monolayer (2D) cell cultures. Organovo hopes to create constructs in 3D that could potentially replicate human biology.

According to the 10-K, Organovo’s technology is derived from the research of Dr. Gabor Forgacs, a professor at the University of Missouri. The company currently holds licenses to patents from the University of Missouri-Columbia, Clemson University, and Becton Dickinson. The Company has outright ownership of six other patents.

Organovo’s path to its current point in the development process has been long but the company still has far to go.

In 2004 Dr. Forgacs began working on organ printing at the University of Missouri-Columbia when his team was awarded the $5 million National Science Foundation Frontiers in Integrative Biological Research (FIBR) grant. This same team subsequently filed the first patent application for the NovoGen™ bioprinting platform. Following the technological developments under Dr. Forgacs direction, a founding team formed and Organovo incorporated in 2007. In July 2008 the company raised $3 million in angel funding, and Organovo opened laboratories in San Diego in January 2009. As Organovo continues down the path towards commercialization, the company has entered into collaborative research agreements with pharmaceutical corporations and federal grants as well. The company first began to form corporate partnerships in the drug discovery area with pharmaceutical and biotech companies in March 2011. In February 2012 the company went public in a $15.2 financing round. Clearly, the company has grown enormously since its $3 million angel investment in 2008 and $15.2 million financing round in 2012, one and a half years ago. However, Organovo’s technology remains extraordinarily speculative and conceptual. It is likely 10 years away from being any sort of reality.

The key to the company’s technology is the NovoGen MMX Bioprinter™ which the company proudly states it developed within two and a half years of commencing operations. Organovo’s technologies enable various types of tissues to be created using combinations three types of building blocks that themselves include combinations of “bio-ink” comprised of only cells and “hydrogel” comprised of biocompatible gel. The company believes that at least part of the tissues its technology creates could be constructed solely of cells, a key differentiator from older technologies. This feature enables organovo to generate architecturally and compositionally defined functional human tissues for in vitro use in drug discovery and development. This can potentially allow more efficient drug development by eliminating the need for actual human subjects in some cases. To illustrate the enormous utility of this, imagine how much more efficient it would be to test drugs on human tissue that can be constructed in a lab than it would be to test drugs on actual people who must be recruited and for whom safety must be assured. Moreover, tissues created using Organovo’s technology may be more effective than animal testing. Organovo’s fully cellular constructs may also offer advantages in regenerative medicine such as augmenting or replacing damaged tissues. In addition to products for use in drug discovery/development and regenerative medicine, Organovo plans to sell 3D bioprinters for use in medical research and a portfolio of consumables for use with the bioprinters. The role of consumables is conceptually similar to the role of ink in the business model of traditional printer manufacturers.

While the products Organovo is developing may in the long term represent significant advances over today’s technology, the company is innovating in a rapidly changing field, and by the time the company’s products reach the market the landscape may be very different. While Organovo works on their 3D printing technology, pharmaceutical, biotech and diagnostic companies, as well as research institutions and government agencies are pursuing related technologies that have the potential to make Organovo’s technology obsolete. In fact, the scariest thing is that it is very possible that this obsolescence could occur before the company is even able to realize any material revenues from its technology.

Disclosure: I am short ONVO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

MDXG: All signs say sell

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MiMedx Group (MDXG) is a very interesting company which could potentially have a promising future.  But at the current price there is now substantial downside risk with very little chance for further upside.

There have been a small number of factors which pushed its share price up by 60% in recent weeks, making its peak gains since 2012 in excess of 600%.

However, we are now seeing the convergence of several very strong and concrete sell catalysts which could presage a drop of at least 20-30% in the near term. The recent departure of the chairman and founder, along with his large sales of stock have already begun to cause the shares to start dropping daily.  The next leg down will likely be the result of a massive S3 offering where other insiders will be cashing out.  The total size for the S3 is a very large at nearly 25% of the company’s market cap.

MiMedx describes itself as a developer of “regenerative biomaterial products processed from human amniotic membrane”.  The company collects human placentas via a donor program from mothers delivering their babies via C sections.  These mothers can opt to donate the placenta rather than have it discarded as medical waste.  The placentas are then processed into products which can be used to aid healing in traumatic wounds and burns.

The use of placentas in medical care has been around since the early 1900’s. However it dropped significantly in the 1980-1990’s due to concerns over hepatitis and HIV transmission.

MiMedx now sports a fully diluted market cap of $660 million, however the company has never generated a profit.  Total annual revenues stand at just $27 million.  Revenues have been growing, but the net loss has been consistent for the past few years at around $8-12 million. As a result, the company has no retained earnings and instead has an “accumulated deficit” of $71 million.

At its current stage of development, the company must still spend very heavily on incremental sales and marketing spend to generate any additional revenue. As a result, there is not much chance that MiMedx will see profitability in the foreseeable future.

 

From its quarterly financials, we can see the following data:

-          Gross margin is high due to low cost of donated placentas

-          But typically around 90% of gross profit is consumed immediately by SG&A

-          As a result, losses continue to grow despite slightly increasing revenues

On the balance sheet side, the company runs a very “asset light” business model with only $3 million in Property, Plant and Equipment.  The current cash balance is only $5 million relative to a $2 million quarterly cash burn. Both of these factors mean that there is virtually no cushion of safety relative to its $660 million market cap.

The company now becomes difficult to value because there are no earnings and virtually no cash or even assets.

The stock has had a very good run this year, doubling from $3.84 to over $7.00 in June.  Part of the run has been due to the company’suplisting to the NASDAQ in April. Prior to April, the company had been a relatively illiquid micro cap on the OTCBB.  This event saw the share price immediately pop by nearly 40% from its then price of $5.00 to over $7.00. It is almost always the case that small OTC companies will experience a brief pop following their uplist to the mainstream NASDAQ.

The stock also benefited from being added to the Russell 2000, 3000 and Global Indexes on July 1st.  Index rebalancing means that index tracking funds simply must buy the stock once it is added to the index, regardless of whether or not it may be poised for a near term decline.  Once the stock was uplisted to the NASDAQ, getting it into the Russell was fairly straightforward and was almost guaranteed to provide a boost to the share price. The Russell indexes cover around 98% of all traded small cap stocks, so inclusion of MiMedx was almost a certainty.

Both of these recent catalysts delivered a boost to MiMedx shares, but in both cases they are short term boosts that were not the result of fundamental business changes.

There have recently emerged several very obvious “sell signals” at MiMedx.

The biggest question for shareholders to ask is “why should we keep holding as the company and the insiders are selling millions of shares at the top ?”.

First, MiMedx’s charismatic and well known Chairman (Steve Gorlin) juststepped down to pursue other interests as of June 26th.  His resignation came shortly after the company was successfully uplisted to the NASDAQ.  An 8K was filed, but there was no press release communicating the resignation to the street.

Mr. Gorlin had been Chairman since its inception in 2008.  He has also been the influential founder of a host of other successful biotech companies including Hycor Biomedical,  Theragenics Corp, CytRx Corp, Medicis, EntreMed, MRI Interventions, DARA BioSciences, and Medivation.

Mr. Gorlin is not just stepping down from MiMedx, he is also selling stock in large size.

In the past year, Mr. Gorlin has already sold over 1.1 million shares, including 50,000 shares which have been sold since the uplisting. His most recent sales were completed at $6.46, but his earlier sales from late 2012 were as low as $2.70.

When key leaders at a company decide to step down and sell their stock, it is always worth noticing.  These are presumably the individuals that know the most about a company and the prospects for its share price. Even when they are stepping down, they always have the option of holding on to their shares. But in this case Mr. Gorlin has been selling heavily.

But the biggest catalyst for a potentially sharp move downwards is the filing of a massive S3 registration statement by MiMedx which allows for the sale of $150 million in stock – nearly one quarter of the market cap of the entire company. This statement was just filed in July.

Two thirds of the shares to be offered will be new shares, delivering up to $100 million in proceeds to the company.  But one third of the shares (around $50 million worth) are coming from selling stock holders who are looking to exit their position in MiMedx.

Having $50 million in stock coming from selling shareholders sends a very strong sell signal to those who are still in the stock.  Meanwhile a deal size which is around 25% of the company’s market cap is likely to cause an automatic drop of at least 20-30% once the shelf becomes effective in the next few weeks. This would imply a price somewhere below $5.00.

MiMedx is not a widely followed stock, with only two boutique analysts covering the company.  Neither one is from a major Wall St. research house.  However, these downward catalysts have not escaped the attention of some of the more astute shareholders. The share price has already begun to decline in the wake of Mr. Gorlin’s resignation and the filing of the S3.

The investors who are doing the selling are no doubt asking themselves why they should wait around as the company and insiders sell millions of shares into the market.  The near term direction of the stock is now quite predictable.

Prior to Mr. Gorlin’s resignation 3 weeks ago, the stock had hit a new high of $7.72.  Following the resignation, the stock quickly came off by around 10-15% before stabilizing.  The shares had recovered to $7.00 by July 2nd.  When the S3 was filed on July 3rd, the stock once again quickly dropped to $6.50.

The shares have continued to grind lower since that time and are now testing the $6.00 mark.

Predicting the actual offering price for the massive secondary is difficult for several reasons. First, the stock is up 600% since 2012.  New investors will clearly require a substantial discount to ensure they are not buying at the top of a spike.  Second, the size of the offering is so large that it will be difficult to manage in terms of daily trading volume and percentage of float.  And third, given that the company still has minimal revenues, no profits and minimal assets or cash, there is no “intrinsic floor” above which MiMedx should trade.

As a result, an offering price of $4.50-5.00 is most likely to be the case. This represents about a 20-30% drop from current levels. At prices below $4.00 MiMedx starts to present an attractive buy.  But at prices above $5.50, there is still clearly substantial downside.  At prices above $5.50, MiMedx is clearly either an “avoid” or a “short”.

Company fundamentals – longer term prospects

Over the short term, the insider selling and the huge S3 offering will clearly control the direction of the share price.  But once that overhang is removed, MiMedx will trade according to its fundamentals and performance. As a result, over the longer term, it is necessary to have a better understanding of the company’s products and their prospects.

MiMedx’s primary technologies are AmnioFix and EpiFix in tissue repair, which together constituted 95 % of revenues in 2012.

MiMedx went public via reverse merger in 2008, but it was only in 2011 that the company acquired its primary tissue repair business in the form of Surgical Biologics. At the time of the acquisition Surgical Biologics developed allografts (tissue transplants) processed from the membrane of the amniotic sac to be used for a wide range of medical applications including ocular surface repair, gum repair, wound care, nerve/tendon protection, spine surgery and burn treatment among others.

Following the 2011 acquisition, the new company launched what are now the company’s key products. First MiMedix launched AmnioFix to enhance soft tissue healing. The primary applications for AmnioFix are in surgical, sports medicine, and orthopedic medicine. Shortly thereafter the company launched EpiFix, a similar product but repurposed for enhancing wound care, especially the healing of chronic, hard to heal wounds such as burns and diabetic foot ulcers. MiMedx believes the wound care market is the largest opportunity.  Both Products are derived from dehydrated Amnion/Chorion membrane (dHACM) using MiMedx’s proprietary purion process which produces dHACM from donated amniotic sacs. To protect the critical IP of the Purion process, MiMedx has 5 issued patents, and over 20 pending. The key to the effectiveness of both products are the numerous growth factors, cytokines, and extracellular matrix proteins in dHACM. Not only do the company’s products reduce time, but also total cost to heal a soft tissue injury. Notably, MiMedx’s products also have a five year shelf life at room temperature.

 

A key distinction between MiMedx and other companies with novel healthcare offerings is that MiMedx’s products have not been approved or reviewed by the FDA as they qualify for section 361 of the Public Health Service Act. As stated by MiMedx’s 10-K, if a product qualifies for Section 361, “no FDA review for safety and effectiveness under a drug, device, or biological product marketing application is required.”

 

While the company has already implanted its products in many patients, it is impossible to know the exact impact of this regulatory difference over the long term. The most notable risk from this specialized classification is the possibility that the FDA could reclassify it. Obviously this would be enormously detrimental to MiMedx’s businesses, as the company could potentially be forced to apply through the typical lengthy and expensive FDA approval process. As stated in the 10-K, “We also cannot assure you that the FDA will not impose more stringent definitions with respect to products that qualify as 361 HCT/Ps.”

To qualify for section 361, a product must be minimally manipulated (from the original tissue), intended for homologous use, manufactured with nothing except water, crystalloids,  or sterilizing/preservative agents, and not dependent on living cells for its primary function. It appears that if the definition of homologous use were made more stringent, MiMedx could be at risk.
MiMedx has experienced strong revenue growth as the company’s products have been adopted in various situations requiring regenerative therapy. Of 2012’s $27.1 million in total revenue, 48 % was derived from surgical and sports medicine (AmnioFix), 42 % was derived from wound care (EpiFix), and 10 % was derived from other sources. However, the company expects EpiFix sales to overtake AmnioFix sales. Following the departure of founder Steve Gorlin, MiMedx is run by Chairman and CEO Pete Petite.  

Conclusion

MiMedx is an interesting company with an interesting product.  Regardless of whether investors are selling at $5.00 or $7.00 the stock can still be considered a homerun vs. its price of just $1.00 last year.

Revenues continue to grow, but the required SG&A spend has continued to prevent MiMedx from breaking a profit. The company has only $5 million in cash and only $3 million of Property, Plant and Equipment.

Given that the company now sports a $660 million market cap, it is easy to see why recently departed founder Steve Gorlin and other insiders have been quick to want to sell millions of shares at current prices.

The S3 statement sets MiMedx up to offer $150 million in stock, roughly one quarter of the company’s current market cap. As a result of the size and the large component which is insider sales, the upcoming offering will most likely be priced below $5.00.

The insider selling and the massive S3 overhang mean that the next 20-30% of downside in the stock is highly probable in the near term.

But at prices of $4.00-5.00, the stock could start to become an attractive buy depending on how the business continues to build.  It should be kept in mind that at prices of $4.00-5.00 (post offering) MiMedx will be very well funded with over $100 million in cash.  In addition, the overhang from selling insiders will have been removed.  Both of these strengthen the buy argument for MiMedx at prices of $4.00-5.00.

 

IDT set for 50% drop

stock decline

 

Two weeks ago, I wrote an article on Erickson Air Crane (EAC). I predicted the stock would decline by 50% once the market better understood the company’s troubled situation. Erickson declined by 25% that day. Before the day was even done, law firms began announcing investigations into breaches of fiduciary duty by Erickson. Following my article, there are now 6 separate investigations ongoing and the share price has retreated 35% from its recent highs.

Yet prior to my article, the stock had been a triple this year. It had been featured on Cramer and had been the subject of numerous bullish articles predicting a further doubling of the stock. Instead, it will likely give back all of its gains this year, and potentially even more.

Another company which appears headed for a very rapid 50% decline is IDT Corp. (IDT). The stock has many of the same problems as Erickson, yet has doubled this year based on the market’s complete failure of analysis. Once the market gets a clearer picture, IDT is likely to return to well below $10.00, where it was in April, and where it has spent most of the past year.

Like Erickson, there is virtually no short interest in IDT (around 2%). The stock has risen sharply, but clearly not due to a short squeeze. Once long investors reevaluate, there is nothing to support the stock or slow its decline. This is part of the reason for the speed of Erickson’s decline, and it is also why moves down in IDT will be just as sharp.

And just like Erickson, there is a very near term catalyst for the 50% drop in the next few days or weeks.

IDT itself is a very boring company. 99% of revenues come from discount long distance calling services, including those familiar prepaid IDT phone cards, “PIN-less” long distance calling and traffic termination services. That business shows huge volume (over $1.5 billion in revenues) but razor thin margins of 1-2%. As of the most recent quarter, the company is losing money once we look past one time accounting gains. In years past, the company was doing well over $2 billion in revenues, but now the business of international long distance is facing increasing competition from free internet providers. IDT has been able to stem some of the losses by successfully stealing business from competitors in this declining industry. But over the longer term, it is clear that the business of discount long distance will continue to shrink overall.

But those are longer-term problems. The real problems for IDT are much nearer term.

IDT CEO Howard Jonas owns 23.5% of the shares, but due to the dual class share structure, he controls 74% of the voting rights. Like Erickson’s controlling shareholder, Jonas has taken to making the company his private fiefdom, taking actions which may be to the detriment of other shareholders. His extraneous ventures with company funds into projects such as oil shale in Israel, hedge funds, consumer debt collections, Hispanic food delivery, comic books, wireless spectrum assets and technology IP patent litigation, have now lost IDT at least $1 billion.

Crain’s New York Business quoted Mr. Jonas, saying

Every day, entrepreneur Howard Jonas says, he fights an imaginary hydra-headed creature called the Meligoth.

Mr. Jonas got his start selling hot dogs across the street from a methadone clinic and has also dabbled in selling mail-order horoscopes, teak chopsticks and travel brochures.

Crain’s details how Mr. Jonas’ penchant for investing company funds into get rich quick ventures resulted in the share price sinking to just 74 cents a few years ago – a 99% drop. At the time of the Crain’s article, Mr. Jonas’ scheme of the moment was a digression from telecom into shale oil. IDT’s share price performed extremely well based on the red hot prospects for shale at the time, which were much brighter than that of its languishing phone card business.

But, as with the others, this new and unfamiliar business failed. So IDT simply spun it off to shareholders. Once shareholders realized that there were no more hot prospects in a new area, IDT’s stock quickly plunged by more than 50%, from $20.00 to around $8.00. It was back to being a non-profitable telecom company once again.

As we can see, the spin off was a “buy on the news, but sell (HARD) on the event” type of trade.

(click to enlarge)

The catalyst for a 50% drop in IDT

IDT’s latest failed venture (Spectrum Communications) has been in the areas of wireless spectrum and “IP Patent Litigation.” IDT spent hundreds of millions in company funds on this venture beginning in 2001. It recently sold a few of its spectrum licenses for a few million dollars, with IDT keeping the few million in proceeds. But the businesses never made money. In 2012, total revenues from these companies amounted to just $600,000, despite the hundreds of millions in investment over a 12-year period.

As it has done many times in the past, and with many varied new ventures, IDT just announced it would be spinning off these undesirable assets. The spinoff was announced in May and should be completed imminently.

Once that happens, IDT will go back to being just a money losing telecom with minimal growth and razor thin margins. Of greater concern is that investors will now get a chance to see first hand the economics behind the hundreds of millions of IDT funds that were wasted on this speculation.

As before, the share price is likely to plunge by 50% back to below $10.00. Investors had pinned their hopes on IDT’s success in these divergent businesses to pull IDT out of its telecom malaise. But IDT will no longer be able to hold out those hopes once these assets are spun off.

Mr. Jonas has demonstrated that he is comfortable with entering into numerous related party transactions with himself, his family and the several other companies he owns. This has likely helped him push through this string of massively destructive transactions which have no relevance to IDT’s telecom business.

Mr. Jonas appointed his son Shmuel (aka “Samuel”) Jonas as the COO of IDT. Shmuel’s previous experience was as an apartment manager in the Bronx and as an operator of a frozen dessert delivery business. Shmuel became a member of management at the age of 25 and currently earns over $400,000 per year.

Mr. Jonas also appointed his other son Davidi (aka “David”) Jonas as CEO of the Spectrum spin off. Davidi’s former experience was that of a Rabbi in the Bronx and a high school teacher of Judaic studies. Davidi is 26 years old and has been employed by IDT / Spectrum since 2012. How these experiences translate into running a struggling public company focused on wireless spectrum and IP patent litigation remains unclear.

IDT’s General Counsel (responsible for approving its large corporate transactions and spin offs) happens to be Mr. Jonas’ sister, Joyce Mason.

IDT obtained its insurance policies from IGM Insurance Brokerage, owned by Mr. Jonas’ father, his mother and his brother in law (Jonathon Mason).

Mr. Jonas also appointed his son-in-law (Michael Stein) as Vice-President of Corporate development.

His other company (Jonas Media group) gets cheap office space from IDT, and last year owed IDT $300,000. Separately, IDT Domestic Telecom has paid up to $300,000 to lease office space from Howard Jonas and Shmuel Jonas.

Following its spin-off, Howard Jonas became Chairman of IDT’s CTM spin off. He is also Chairman of IDT spin off Genie Energy. He continues to be extremely well compensated by these companies even after they are spun off from IDT, currently earning 7 figures.

One recent development deserves particular notice.

Prior to approving this latest spin off to shareholders, Mr. Jonas awarded himself 10% of the equity in Straight Path IP. Presumably this was all approved by his sister and his son. More details on the problems with Straight Path are provided below.

IDT has financial problems, strategic problems and corporate governance issues. But there is a reason why the market has missed these problems at IDT, causing the stock to double.

Institutional ownership is very low. The only fund that is a 5% holderhappens to be a Vanguard index fund. Index funds do not do stock specific research. Instead they try to simply track the overall indices.

In addition, there is no mainstream research coverage of the stock, despite its $500 million market cap. There is simply no institutional commitment to this stock by those who invest or provide research.

The few funds who own IDT have no idea what it is they are sitting on.

Like Erickson, IDT insiders have become quick to sell substantial amounts of their stock. Director Eric Consentino recently sold 75% of his holdings,Bill Pereira (President of IDT Telecom) recently sold around 70% of his saleable stock. When options vested in June, General Counsel (and sister of CEO Howard Jonas) Joyce Mason twice sold 100% of the underlying shares on the exact same days.

IDT occasionally receives the benefit of positive articles and headlines which consistently point out the following bull case:

  1. Strong cash balance of $160 million
  2. Low P/E ratio of 9 times earnings
  3. High dividend yield of 6%
  4. Strong share buyback program
  5. “Hidden undervalued assets”

This is why the stock has risenYet even a simple analysis will prove that all 5 of these points are all entirely wrong.

When the market actually does some analysis, it will find that:

  1. The cash is already spoken for
  2. The company is losing money (negative P/E)
  3. The dividend has been cancelled
  4. The buybacks have been discontinued
  5. The “undervalued assets” are more likely to be a liability going forward.

Without institutional ownership or research coverage, these mistakes have been entirely missed by the market, even as the stock has doubled.

Because the stock has doubled due to mistaken information, once the current holders realize see these mistakes, the 50% correction is likely to be both swift and steep.

1. Strong cash balance of $160 million – WRONG!

Every positive mention of IDT seems to point out that the company has $160 million in cash, representing 1/3 of its market cap. Clearly (they say) this makes it a “safe” stock to own.

Yet a closer look reveals that this cash is more than already spoken for.

Since the last quarter, the company has paid down the mortgage on its headquarters for $21 million, reducing cash to around $140 million. (The headquarters had been abandoned within 1 year of its purchase at the peak of the US real estate market.)

Against its new cash balance of around $140 million, IDT has $270 million of current liabilities, including:

  • $151 million of already accrued expenses
  • $90 million of deferred revenue
  • $25 million of customer deposits received
  • $4 million in other current liabilities

For anyone conducting the analysis, it is plain to see that IDT actually has a negative current account. This condition was notable enough that it had to be disclosed in the recent 10K under Liquidity and Capital Resources. IDT disclosed a “deficit in working capital” of $33.4 million.

So it turns out that because of the huge liabilities, IDT is cash poor, not cash rich. This explains why IDT has stopped paying dividends and is no longer buying back stock. There is nothing “safe” about a stock with this type of liquidity position.

2. Low P/E ratio of 9 times earnings – WRONG!

In the most recent quarter, IDT reported revenues of $397 million and net income of $8.7 million.

The Motley Fool then embarrassed itself with a computer generated headline stating

IDT Beats Analyst Estimates on EPS

This was downright silly for 2 reasons. First, there is only 1 analystcovering the stock. But even small, boutique firm Chardan Capital just downgraded the stock to “hold.” The Fool has simply repeated automatic data feeds from CapitalIQ, leading some to believe that IDT has both analysts and earnings.

In fact, these “earnings” were actually the result of one time accounting gains due to resolution of prior legal matters. Otherwise IDT would have reported a net loss rather than a profit. In order to see this, one must actually read the financials rather than use a computer to simply scrape numbers from Yahoo and Google Finance sites. The downgrade from Chardan is no doubt the result of the loss being incurred by the business once we exclude gains. There is also no reason for shareholders to expect any value at all from the spin off of the disappointing spectrum assets. The Spectrum spin off will have just 3 employees, one of whom is Mr. Jonas’ 26-year-old son.

Management put a good face on things. Despite the fact that the business is now losing money, management noted “This is the 13th consecutive quarter of year-over-year increases [in revenue].” The revenue increases have been the result of the “PIN-less” Boss Revolution service, which has cannibalized the historical business of physical cards that IDT offers. It has also stolen revenues from other companies who offer physical phone cards. Yet over the longer term, it will be difficult to grow the business of offering international long distance discounts. Services such as Vonage offer free international calls, while services such as Skype even allow free video calls to foreign countries.

What we now have is a company that has inadequate cash whose business is now losing money in an industry which is facing competition from free service providers.

But there is even more to the story.

3. High dividend yield of 6% – WRONG!

Some investors continue to view IDT as a dividend stock. In 2011, the company made 4 dividend payments. In 2012, the company made the first 3 dividend payments. But IDT missed its December 2012 dividend and has not made a payment during the first half of 2013.

Clearly investors would like to see IDT resume dividend payments. But if the company were to resume its dividends, the drain on cash would exacerbate its already problematic current account deficit.

Neither of these situations is good. Yet some small investors continue to regard IDT as a “safe” and desirable “cash rich dividend stock.” This is obviously not the case. And once again, we can see that the problem is a lack of cash.

4. Strong share buyback program – WRONG!

In 2012, when the share price was at around $9.00 (and when IDT still had ample cash), the company was still buying back stock (and it was still paying dividends). However these purchases ended in July of 2012, and there have been no disclosed purchases since.

The two problems that IDT faces now are:

  1. It doesn’t have the cash to buy back shares
  2. The shares are trading at the highest level since 2011 (right before the GNE spin off)

As with the dividend, current investors would arguably like to see a buyback. But likewise, the drain on cash would be a significant negative. In addition, buying back shares of a company whose business is losing money while the stock is at a 3 years high would be unjustifiable for a company with noticeable cash constraints.

5. “Hidden undervalued assets” – EXTREMELY WRONG!

The notion that IDT might have a number of “hidden assets” which were being obscured within the bowels of a sleepy telecom company is what got several small, independent authors excited. This a primary reason why the stock has recently doubled.

In fact, these “hidden assets” are actually the greatest cause for concern. This is where IDT is destroying value and awarding sweetheart deals to its CEO who controls the votes.

Over the past 10 years, IDT has repeatedly tried to branch out into a business that will get it away from the declining, low margin business of providing long distance services.

Crain’s wrote an entire section entitled:

Beyond Phone Cards: IDT’s Record of Diversification” with detailed performance metrics, which I include as Appendix I.

Each time a “new, new thing” emerges in the investment world, IDT has been quick to jump in. They have typically jumped in at peak prices. This has included such diverse activities as hedge funds, distressed consumer debt collection, wireless spectrum, shale oil in Israel and even comic books, among other things. IDT tends to get into these activities even though they are far removed from the company’s core business of providing long distance.

Once IDT realizes that it will not strike it rich on these businesses, the investment is simply spun off to shareholders.

Past examples include the following:

  • Genie Energy (GNE) which was spun off to shareholders in 2011. Genie shares have remained flat, but the spin off company has swung to annual losses following the spin off. While part of IDT, the company entered the oil shale business in Israel at the peak of the oil boom in 2008, following its entry into retail energy distribution in 2004 (natural gas). The GNE spin off resulted in a quick 50% drop in IDT shares.
  • IDT Carmel consumer debt collection. Close to the peak of the credit bubble, IDT expanded into debt collection and investment in past due debts. IDT ended up exiting the business in 2009 (at the bottom of the credit crunch). It sold the portfolio of past-due debt with a face value of $952 million for just $18 million.
  • CTM Media. Over the space of several years, IDT invested in a wide range of media assets, including brochures, comic books and the broadcast license of an AM radio station. The media assets were spun off in 2009 and IDT recorded impairments of over $30 million on CTM related assets. Following the spin off, the board changed Mr. Jonas’ cash compensation agreement and awarded him 1.8 million shares at around 60 cents per share. CTM conducted a 1:20 reverse split in 2011 and now trades on the OTCBB, however, there is effectively no volume.
  • Real estate. At the peak of the real estate boom, IDT invested in a new corporate headquarters in 2008, paying over $50 million. Within 1 year of the real estate purchase, the headquarters had been abandoned. The headquarters is currently still marked on the books at $42 million, but IDT says that it is currently unable to determine its value. IDT says that it will try to determine recoverability in Q4 2013 and will report any impairment at that time. The balance of the mortgage was recently paid down following dispute.
  • Hedge funds. In July 2007 (the last peak of the stock market), the company had investments in “pooled investment vehicles including hedge funds for strategic and speculative purposes” which totaled $112 million, out of a total of $661 million in cash and investments at the time. Investment in hedge funds is now down to around $10 million (but is not marked at fair value) while cash is down to $140 million.
  • Wireless spectrum licenses (Straight Path Communications). In 2001, IDT acquired wireless spectrum licenses from bankrupt Winstar holdings for around $55 million. In 2009, IDT recorded impairment charges of $62 million on these assets. In Q3, the company recorded a gain by selling a small number of the assets and is now spinning off the remaining assets. IDT ended up wasting $300 million to build a backhaul network, but its Spectrum president noted that they were “five or six years too early.” In an odd twist, IDT then sued that former president for diverting 200 of the best licenses to his own business. The president counter sued.

The point is that IDT’s board and management have a history of approving and entering into forays into new, unrelated businesses which have nothing to do with long distance. The company sticks with it for a few years, but when material revenues repeatedly fail to occur, the company simply hands the assets to shareholders via spin offs.

One more recent venture is Straight Path IP which is engaged in the now hot sector of pursuing technology patent litigation. Following wins by companies such as VirnetX (VHC) and Vringo (VRNG), the space became very “hot” with billion dollar potential. The sector has also been chased by substantial amounts of inexperienced “hot money,” bidding up prices.

The most troubling aspect of this transaction is that prior to the spinoff, IDT simply awarded 10% of the equity to CEO Howard Jonas as personal compensation. The shares vested immediately. This business is a lottery ticket. In all likelihood, it will end up not being a home run. But in the event that the IP practice does win a big suit and strike it rich, Mr. Jonas received his lottery ticket for free, after it had been purchased using company money. Lottery tickets are typically dumb investments, but a free lottery ticket is always worth keeping if you can get someone else to buy it for you.

The newest “new, new” ventures – Fabrix and Zedge

Shale oil is not hot anymore. Nor are wireless spectrum, comic books, real estate, consumer debt or hedge funds. As a result, IDT has focused on two even newer “new, new things.”

The company is once again getting into the red hot sectors of the day – “cloud based video streaming” and “mobile apps and services.” Unfortunately, once again these investments are not making any money and IDT has no experience in these areas.

In December, IDT increased its stake in Fabrix to 86%. This trade cost $1.8 million for an additional 4.5% stake, implying a total stake value of around $35 million. Fabrix is in the red hot (but nascent) business of “cloud based video processing, storage and delivery.” Revenues for the past quarter were just $2.6 million and the venture is still losing money.

IDT also holds an investment in Zedge Holdings. This business provides wallpaper and ring tones to cell phone users. Although it generates many viagra online discount clicks, the business is generating revenues of $1 million per quarter, just breaking even at $100,000.

These latest lottery tickets provide no visible benefit to IDT even though they were very expensive to acquire. Telecom continues to account for $1.5 billion in revenue. As a result, IDT continues to divide its reportable segments into Telecom Platform Services (99% of revenues) and “all other” (just 1%). The 1% in “all other” comprises Zedge, Fabrix, Straight Path IP, Straight Path Spectrum, Real Estate and “other small businesses” – combined!

At just 1% of revenues, “all other” assets continue to suck up IDT’s time and money. Yet they have consistently failed to live up to the excessive hype. Those counting on these areas to further boost the share price are simply not reading the numbers. They are also ignoring the steady stream of similar failed ventures in IDT’s past.

Conclusion

IDT has recently logged triple digit gains on the back of several extremely enthusiastic articles which have ignored the details of both the current financial condition and the past history of failed high profile ventures. The stock has benefited from computer-generated headlines which inaccurately portray the current financial condition.

In contrast to these headlines, the stock is not cash rich, it doesn’t pay a dividend, it isn’t buying back shares and it is now losing money (once we look past one time accounting gains). Following the 100% run-up, this puts IDT’s shares in a very precarious position.

CEO Howard Jonas owns 23.5% of the shares, but controls 74% of the votes. As a result, Mr. Jonas can run IDT any way he wants, even to the detriment of all minority shareholders.

At least 6 of his family members have been able to benefit from employment and contracts. Meanwhile, his son and his sister are the ones responsible for approving the transactions which award Mr. Jonas personal equity stakes in these projects bought with company money. This raises very serious fiduciary and corporate governance issues.

IDT continues to derive around 99% of its revenues from the boring and low margin business of discounted long distance calls and termination services. This has been consistent even though the company has engaged in a large number of large and speculative ventures into the latest “hot investment” areas of the past decade.

In each case, IDT sticks with the “new, new thing” for a few years and then simply spins off the business to shareholders as it returns to its sleepy legacy business. Then, when a new hot investment idea comes up, IDT tries its hand again.

The latest ventures (Fabrix and Zedge) have all the elements to make for great cocktail party chatter for CEO Mr. Jonas. But the “cloud based video storage” and wallpaper / ringtones have not generated material revenues (much less profits). In a year or two, these businesses will likely be the next in IDT’s long series of spin-offs of unrelated businesses to shareholders. IDT will then continue on as a low margin provider of long distance.

IDT has overshot its share price by 100% now. The few institutions who own it appear to have very small passive positions and there is virtually no research coverage.

Meanwhile, this is a stock that has been untouched by the shorts. Short interest stands at just 1-2% of shares outstanding. As a result, as the long funds sell into the spike in the share price, there is no short covering to support the stock on the way down.

As soon as current investors catch on to the mistakes that have been made with IDT, the share price should experience a fairly rapid correction of around 50% to $10.00 or below.

The clear catalyst for the 50% drop will be the spin off of the nearly worthless assets of Spectrum in the next few days or weeks.

Appendix I – “Diversification” at IDT

This section comes from the article and interview in Crain’s which describes IDT’s history of using coming money to fund failed ventures in totally unrelated businesses.

Beyond Phone Cards: IDT’s Sorry Record of Diversification

Credit Card Collections Business
Launched in 2006 with $78 million purchase of debt portfolio. Generated operating losses of $77 million until IDT sold the portfolio in 2009 for $18 million and exited the business.

Vitarroz Food Products 
An IDT subsidiary bought it in 2006 for $5.2 million. IDT’s ethnic grocery division produced $7.3 million in losses over 2008 and 2009, and the company exited the business in 2009.

IDT Global Israel 
Launched in 2003 at undisclosed cost. Generated $19 million of losses over three years ended in 2008. Sold in 2008 for what IDT calls a “nominal amount” and recorded an $8.8 million loss.

Liberty Broadcasting 
IDT bought a radio network in 2001 for an undisclosed sum and launched a conservative talk network in 2003. Sold it in 2005 for an undisclosed amount after suffering $7 million in write-downs.

IDT Entertainment 
Launched in 2003. Generated about $40 million in losses over its life before it was sold in 2007 for $220 million in cash and other considerations.

Headquarters at 520 Broad St., Newark 
IDT acquired building in 2008 for more than $50 million in cash and assumed debt. Abandoned building in 2009 as staff shrank. Building is now empty.

 

Disclosure: I am short IDTEAC. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

EAC to drop 50% on insider deal

BrokenHeli

Not long ago, ZM Funds was in a serious pickle. It was the largest holder of $120 million in second lien debt from a deeply distressed helicopter operator called Evergreen Helicopter. Evergreen has received a going concern letter from their auditor. It was in default on its debt. It was not even paying its accounts payable to such an extent that suppliers began withholding parts and Evergreen was unable to maintain its aircraft. At present only 50% of its aircraft are even being used and the company is the defendant in multiple lawsuits and legal proceedings with its creditors, suppliers and customers demanding immediate payment. But in fact, the situation was set to get far worse for struggling Evergreen, given that over 60% of its revenues come from DOD contracts in Afghanistan. The US has already announced that the pullout from Afghanistan is set to accelerate and troop levels will be further reduced by 50% in the next year.

In short, it was clear that ZM would not get repaid on this very large subordinated and distressed debt holding.

Fortunately for ZM Funds, an elegant solution was found. ZM is the controlling shareholder of Erickson Air-Crane (EAC) and holds two board seats. Following its recent equity offering, Erickson has a market cap of around $350 million. ZM simply had Erickson, the company that it controls, borrow $400 million in debtand a $100 million credit facility to buy the crippled and indebted Evergreen. Prior to the borrowing, Erickson was down to just $1 million in cash and already had $100 million in debt, so this represents a very substantial levering-up.

In exchange for its deeply distressed debt of Evergreen, ZM received millions of shares of Erickson, which had been rising strongly. As we will see below, as soon as the questionable acquisition was completed, ZM quickly began liquidating its shares in Erickson and has just filed to sell 100% of its entire stake in Erickson.

Apparently this is all fine and legal, simply because Erickson had disclosedthat it is controlled by ZM. It notes that ZM may take certain actions and approve certain transactions which are not in the interests of other shareholders and which other shareholders would not approve. That is certainly putting it mildly.

That acquisition of Evergreen took place just a few weeks ago. The company has put a positive spin on the deal, noting that it will increase revenues, along with “adjusted EBITDA”.

Despite the enthusiasm and urgency of Erickson and ZM, the transaction is far from intuitive. In fact, in makes no sense whatsoever. Rather than help Erickson, this acquisition is more likely to sink the entire ship for Erickson.

Portland based Erickson has traditionally derived the majority of its revenues from firefighting and timber operations in North America, not far flung Afghanistan. With respect to the distressed Evergreen acquisition, Erickson disclosed the following:

  •  lack of experience in these business segments
  •  lack of experience with these types of aircraft
  •  lack of experience in these geographic regions (Middle East, South America and Africa)
  •  NO experience with Department of Defense customers and projects

For obvious reasons, ZM is clearly eager to get out of its holdings of this now debt-saddled company as fast as possible. As soon as it was completed, ZM quickly sold millions in stock. And now, 2 days ago, a massive S3 registration statement was filed in which ZM will sell 100% of its remaining shares even as the ink on the deal is still drying. The S3 notes that after the offering, ZM will hold zero shares. In addition, Erickson will be offering 4 million new shares.

Astute investors will note that the 9 million plus shares in the S3 filing equates to 100% of the company’s current outstanding share count!

It also equates to over 45 days trading volume. Based on the sheer enormity of this offering, the share price should be expected to automatically correct by at least 50% to around $13.00.

After that, the share price will be a function of how well the debt saddled company can turn around the struggling Afghan helicopter operations of the deeply distressed Evergreen. Unless a drastic turnaround can be made with struggling Evergreen and its Afghan operations, Erickson should easily see the single digits very soon. But by that time, ZM will already be long gone.

Despite these troubling facts, shares sold short represents just 2% of shares outstanding and only 1.5 days trading volume. Large short interest can often support a stock on the way down, preventing it from falling as shorts become buyers. But with Erickson, this is clearly not the case.

This could turn out to be a genius trade of epic proportions for ZM. First, they get their very distressed debt repaid in full. But even better, their repayment came in the form of deeply discounted shares which they now sell at a price which is a triple at current prices. Even if they get out at $13.00, ZM’s trade will represent a spectacular homerun.

Aside from ZM Funds, the stock has few major mutual fund holders. Only two mutual funds own more than 1% of the company. Aside from ZM there are only two 5% holders. As a result, this abusive transaction has gone largely unnoticed. But with the majority owner planning on selling 100% of its shares, and with Erickson now saddled by debt and maintenance requirements of a huge distressed acquisition, it is hard to see how these smaller funds will wait around to be left holding the bag as ZM sells. It is also hard to see how anyone else will buy shares of Erickson as ZM liquidates in the face of the massive acquisition.

Looking further back, Erickson Air-Crane came public just over 1 year ago in a very difficult IPO. At the time, the Oregon company had historically been engaged primarily in providing helicopter services for firefighting and to the timber industry in North America. After being repeatedly delayed for 2 years, the IPO had originally been slated to be priced at $14.00, but weak demand caused the offering price to be cut and the size to be reduced.

The company ended up coming public at $8.00, 43% below expectations. The share price then quickly traded down to as low as $5.35, another 33% below the lowered IPO price.

Even home-team Oregon newspapers were not kind to the company’s prospects, stating

Erickson isn’t gearing up for rapid growth, however. It’s a 40-year-old business just trying to pay down $130 million in debt.

Erickson had been positioning itself for an IPO for nearly two years and repeatedly failed to find buyers for its stock.

So earlier this month, it resorted to cutting its share price and reducing the number of shares offered. “

The debt being paid down was actually being held by Erickson’s the ZM private equity fund. In addition, ZM had been hoping to liquidate shares. Getting this deal done was therefore even more crucial for ZM.

As a result it was reported that:

Discounted shares were evidently still insufficient to attract investors. So Erickson’s owner, the investment firm ZM Private Equity, stepped in and agreed to buy at least 750,000 of the IPO stock itself, and perhaps as many as 1.25 million shares.

ZM, which is also an Erickson creditor, had planned to reduce its stake in Erickson to around 50 percent through the IPO. If it buys the full 1.25 million shares, it will retain a 63 percent interest in Erickson.

ZM ended up having to purchase 1.05 million shares (one quarter of the IPO) in order to keep the IPO from failing and get its debt holdings repaid.

Now, with the acquisition of Evergreen, Erickson has levered up massively. Once again, the reason is so that it can bail out ZM Funds from another distressed debt holding.

Yet the market has clearly missed these important nuances. Since those $5.00 lows, the stock has been a rocket ship and is now closing in on $30.00. Including the effect of its recently issued shares, the company now sports a market cap of nearly $350 million.

The reason for the rise is that the stock benefited greatly from a strong fire season in late 2012. As a result, the company actually turned a meaningful profit in one quarter out of the past five. The result of this single strong quarter is that Erickson posted a positive net income for full year FY 2012.

Erickson has always preferred to avoid any focus on its negative EPS and instead touts its strong “adjusted EBITDA”. And yet even this has received an artificial boost. The company recently changed its methodology for calculating EBITDA, resulting in an immediate boost of 30% without any change in the business. Investors in the stock have largely ignored the fact that the company continues to lose money and was down to just $1.3 million in cash at the end of Q1.

It should be viewed as intuitive that Erickson’s non-GAAP “adjusted EBITDA” numbers will give optimistic results. When a debt laden and capital intensive company simply ignores all of its depreciation, interest and taxes, the strained results are naturally going to be seen as just fine.

In mortgaging the farm to make these purchases, Erickson may have just committed a colossal blunder which solely benefits its controlling shareholder and board member.

The situation at Evergreen is indeed very, very bad. Evergreen’s situation was specifically described as “distressed” in the recent 8K filing. It was unable to make good on its payables, to the extent that its suppliers were withholding parts. It is noted that Evergreen

has been unable to adequately maintain certain of its aircraft

It has also been disclosed that

a number of EHI’s aircraft are not air-worthy, causing dissatisfaction among certain of its customers

At the end of 2012, target Evergreen was down to just $174,000 in cash. Only 50% of its aircraft were even being utilized. The company is now subject to lawsuits and legal proceedings from its suppliers, customers and creditors who are demanding immediate payment.

Despite the deep financial distress, Evergreen does continue to generate substantial revenue of nearly $200 million. It’s just that these revenues do not translate into any ability to generate a meaningful profit or accumulate cash to pay its massive debts or its suppliers.

Erickson is also in the process of completing second acquisition, which is also with a somewhat related party. Air Amazonia is the helicopter subsidiary of one of Erickson’s former customers in Brazil. The acquisition is set to close in Q3 for a price of $65-75 million, yet the company has just 14 aircraft. Like Evergreen, the aircraft utilization sits at just 50%.

With both targets only showing 50% utilization, Erickson has communicated the view that the glass is half full rather than half empty. With such low utilization, they hope that there will be room for improvement. Again, this is a substantial understatement. Yet the company has clearly paid a tremendous price for two companies which are sitting at half idle. In addition, Erickson’s Central Point Oregon manufacturing facility also sits at just 50% of capacity.

Conclusion

With few major holders and very limited research coverage, the rise in Erickson has gone largely unnoticed. The massive related party acquisition of the distressed Evergreen has also gone largely without any analysis by either longs or shorts.

Given that Erickson lacks any relevant experience in acquiring such a company, and given that the Afghan pullout will greatly curtail its revenues, it appears that the only real purpose of the Evergreen deal was to bail ZM Funds out of a 100% loss on a very large position in the $120 million second lien debt. With ZM firmly in control of the votes and the board at Erickson, this was an easy transaction to push through.

Now that this has been done, Erickson is saddled with half a billion in debt and is stuck with a deeply distressed target to manage in a far flung corner of the world.

Although Erickson has made positive statements about the acquisition and the use of “adjusted EBITDA”, it is clear that interest alone on the massive debt will preclude a profit for years to come. In the meantime, Evergreen’s fortunes are tied to Afghanistan.

It is not surprising that ZM is now selling 100% of its holdings in Erickson. Even if it continues to sell at prices which are 50% below the current level, ZM will lock in a tremendous gain and will have recovered all of its exposure to Evergreen’s deeply distressed debt.

The only thing that remains to be seen is if the many smaller holders of Erickson will wait to be left holding the bag as ZM sells.

Disclosure: The author is short EAC

CLNT: Another great pump

pump picture

Last Monday, shares of Cleantech Solutions (CLNT) were trading as low as $3.42. By Thursday the shares had more than tripled to a high of $10.85. The stock, which normally trades around 60,000 shares per day, traded an astonishing 22 million shares over the course of last week.

The timing of this surge was very fortuitous for Cleantech, coming very shortly after the company filed an S3 registration statement for a planned equity offering. Cleantech hopes to raise up to $5 million.

Without the surge in price and volume, any such offering would have been utterly impossible for the company, which had previously been worth only $9 million in its entirety. For those who are interested, the details of this S3 are somewhat unusual, and will be explained in detail below.

The spark for this wild ride was a single press release from Cleantech which noted that Cleantech had become a “certified supplier” to both Sinopec and CNPC. Sinopec and CNPC are China’s gargantuan oil companies which are responsible for many billions in equipment orders every year.

Yet by Friday, the stock had already retreated 30% from the high, to close at $7.68.

As I will show below, the market made an epic misjudgment in sending the share price higher. The result of this is that the share price will likely find itself right back in the $3-4 range in very short order. If Cleantech hopes to take advantage of this surge to raise its $5 million, it had better do so very quickly.

It is certainly the case that many who played this press release did not understand its meaning. It is also certainly the case that many day traders simply didn’t care because they were only in the trade for a quick pop, which was virtually guaranteed.

Cleantech has repeatedly fallen below the $1.00 mark, making it subject to delisting from the NASDAQ. As a result, the company has conducted two reverse splits (a 1:3 and a 1:10). The result of these two reverse splits is that Cleantech now has only 2.67 million shares outstanding. When any spark of good news or hype comes out, the limited supply of shares virtually guarantees a sharp move upwards. In the past, day traders have caught on to this and have been quick to make a quick flip trade off of any positive headlines in Cleantech.

Cleantech’s press release made reference to having “received the necessary third party certifications”. What is not mentioned is that these certifications came from Beijing New Century Certification Co. (北京新世纪认证有限公司) (aka “BCC”). I have confirmed this both with Cleantech and with BCC.

BCC’s website (in English and Chinese) can be found at www.bcc.com.cn. BCC has issued over 24,000 such certificates to various Chinese entities. For Cleantech, certification simply meant creating a sample product which conformed to the right size, shape and forging processing, and delivering it for inspection. Then they paid the appropriate fee and went through the appropriate documentation requirements and voila, they could call themselves a “certified supplier”.

In short, such certifications do not mean all that much. This is especially true in China, where similar certifications are almost always obtained by companies for use as marketing tools. I have often visited various companies in China who have entire walls where similar designations from local governments and certifying bodies are prominently displayed for foreign visitors to gaze upon. Many of these companies have secured their wall full of designations while being engaged in virtually no commercial activity.

For those who wish to confirm certification of an entity, BCC includes a search box on the Chinese portion of its website, found here. Inside the box labeled “Certificate Number” (证书号), individuals can verify all details of certification. Many Chinese companies will post their certificates on their website, such that obtaining the certificate number is very straightforward. However, when I asked Cleantech for their number, they stated (somewhat paradoxically) that “from our laywer’s view it’s not that appropriate to send the certificate to any individual. We will issue this on our website for all the investers (sic) to see in the very near future”.

So until that time arrives, we will just have to wait.

As noted above, the details of the recent S3 registration statement are worth focusing on. Within the Plan of Distribution, it is disclosed that:

we may enter into a continuous offering program equity distribution agreement with a broker-dealer, under which we may offer and sell shares of our common stock from time to time through a broker-dealer as our sales agent.

If we enter into such a program, sales of the shares of common stock, if any, will be made by means of ordinary brokers’ transactions on such securities market or exchange on which our common stock is then traded, at market prices, block transactions and such other transactions as agreed upon by us and the broker-dealer.

Under the terms of such a program, we also may sell shares of common stock to the broker-dealer, as principal for its own account at a price agreed upon at the time of sale.

What this means is that “from time to time”, Cleantech can simply sell shares to a broker, who then acts as a principal. The broker can then re-sell the shares to clients in the market. Ideally the broker could do this entire trade after receiving buy orders for Cleantech shares at a far higher price. This is far different than a standard offering where a company retains an investment bank to conduct a single, large offering. With the Cleantech style of offering, a company can make use of surges in price and volume to bleed shares into the market without any notice.

The S3 was dated as of April 24th, 2013. On that date, the last closing price had been $3.58 and the 5 day average volume was 84,000 shares. Assuming a 20% discount (due to size and illiquidity), a normal offering price would have been set at $2.86. Raising $5 million would therefore require 65% of all outstanding shares to be issued. It would also require a full month’s worth of trading volume to be issued. In short, such a transaction would be essentially impossible.

But with the surge in price and volume, and with the ability to issue stock “from time to time” to broker dealers, such a trade would appear far more achievable for Cleantech. So again, the timing of the share price spike is very fortuitous indeed.

This is not the first dubious transaction for Cleantech.

The last time I wrote about Cleantech was in November of 2012. Author “Biotech Breakthroughs” had written a pump piece on the stock, boldly stating that the stock should be trading at $19.00, up more than 5x from its then-level of around $3.50. The stock immediately jumped by as much as 36% on huge volume.

Biotech Breakthroughs has written on precisely 3 Chinese small cap companies. In each case he predicted stratospheric share price rises on these tiny, illiquid Chinese stocks. And in each case the stock soared for a few days, but then retreated. I have personally visited each of these 3 companies in China, and in each case I felt I had more than adequate basis to suspect varying degrees of fraudulent activity. I have contacted Biotech Breakthroughs, but I have never received a response.

When I wrote about Cleantech, I noted that during my two day visit, I observed only a tiny handful of employees engaged in no meaningful productive activity. I also noted the extremely troubling history of its auditor, Sherb and Co. As I noted, with the exception of Cleantech, 100% of the clients which Sherb signed off on have either been delisted outright due to fraud or have traded down to the pennies once the market caught on. Were it not for the reverse splits, Cleantech would be trading in the pennies as well. A complete list of Sherb’s Chinese audit clients (and their fates) can be found in my original article.

Despite the aggressive and direct nature of my article and a 30% drop in the stock, Cleantech issued no response to it. Instead, about 2 weeks later, Cleantech issued a very different press release noting that

Cleantech Solutions Management Purchase 157,966 Company Shares

As would be expected for a tiny float company, the share price again soared by nearly 50% on millions of shares of volume. What the market missed was the fact that this purchase was conducted solely by the Chairman and his wife. More importantly, the transaction was not an open market purchase, but instead was a new issue of shares by Cleantech to the Chairman and his wife at a price of just $3.88. This amounts to over 6% of the entire company being purchased in a private (off market) transaction by insiders. It is also important to note that this large insider transaction was conducted without shareholder approval.

The share price quickly hit a high of $5.50 on December 4th, but once it settled down, it retreated by to the $3-4 range. The stock ended the year at $3.97.

During that time, Geoinvesting conducted its own visit to Cleantech and briefly took a positive view. They noted that, in contrast to my visit, Cleantech had upped its operations and there was enough activity for their firm to take a short term long position.

Yet in April, Geoinvesting requested further follow-up from Cleantech including:

  • Independent verification of cash accounts;
  • Independent verification SAIC/SAT filings;
  • Independent video coverage of manufacturing operations;

Geoinvesting notes that Cleantech could not comply with this request for independent verification.

Geo’s April 26th report also cites a history of high CFO turnover, raises concern over the S3 and raises concern regarding auditor Sherb.

In contrast to their initial support, Geoinvesting ultimately came to the conclusion that

Given these developments, we cannot further validate CLNT’s operations.

Geoinvesting states that it can no longer support a long position in shares of Cleantech.

So is Cleantech a fraud or not ?

Various market participants, such as Geoinvesting and myself, can only put forth their best efforts at conducting due diligence and do their best to arrive at the correct conclusion. However, none of us are the final arbiters as to the presence or absence of fraud.

However it is worth noting that the market as a whole certainly views Cleantech as a fraudulent company.

In the filings that it reports to the United States SEC, Cleantech claims that it earned a net income of nearly $6 million in 2012 on revenues of $56 million. Yet the market cap of the entire company (prior to the recent press release) stood at just $9 million. This means that Cleantech trades on a PE ratio of just 1.5x. In short, investors as a whole simply do not believe that the financial results (as reported to the SEC) are real.

There are numerous reasons why investors doubt the legitimacy of Cleantech’s results. The wave of China frauds (including by numerous clients of Sherb and Co) which hit the US has resulted in suspicion falling upon all Chinese reverse mergers where results appear to be “too good to be true”.

Shortly after my article in November, Cleantech’s CFO, Wanfen Xu, resigned. In her place, the company appointed Adam Wasserman. Mr. Wasserman was the 3rd CFO to serve at Cleantech during a two year period (which is what gave rise to the CFO concern expressed by Geoinvesting). Mr. Wasserman had previously served as Cleantech’s “vice president of financial reporting”.

Mr. Wasserman’s bio at Marketwatch shows that right now he is concurrently acting as a senior management figure for no less than 6 small US and Chinese companies including:

  • CFO at Sanborn Resources
  • CFO at Yew Bio-Pharm
  • CFO at Oriental Dragon Corp
  • CFO at Westergaard.com
  • CFO CFO at Cleantech Solutions
  • CEO at Oncall Inc.

Again, he currently is fulfilling all of those management duties at the same time. Typically each and every one of those roles would comprise a full time job for any one individual. So it is difficult to imagine how much attention Mr. Wasserman is devoting to Cleantech in China.

At the rather young age of 48, Mr. Wasserman’s resume also includes a very, very extensive list of small companies for which he has acted as a senior management figure, including:

  • CFO at Lotus Pharmaceutical (Chinese reverse merger)
  • CFO at Gold Horse International (Chinese reverse merger)
  • CFO at Pershing Gold Corp
  • CFO at Bohai Pharmaceuticals (Chinese reverse merger)
  • CFO at Staffing 360 Degrees
  • CFO at CD International
  • CFO at Transax International
  • CFO at Relationserve Media
  • CFO at Colmena Corp
  • CFO at Explorations Group
  • CFO at Genesis Pharmaceuticals
  • CFO at Cenuco
  • CFO at Options Media Group
  • CFO S.E. Asia Trading Co.
  • CFO Speedhaul Inc.

None of these are necessarily very lucrative roles. For example, at Cleantech Mr. Wasserman is only paid a base salary of $52,000. But when holding 5 or more simultaneous CFO roles, the compensation will no doubt add up.

As of its most recent 10K filing, Cleantech disclosed the following regarding itsineffective internal controls designed to prevent fraud:

Management conducted its evaluation of disclosure controls and procedures under the supervision of our chief executive officer and our chief financial officer.

Based on that evaluation, Mr. Wu and Mr. Wasserman concluded that our disclosure controls and procedures were not effective as of December 31, 2012.

In the case of Cleantech, its financial statements themselves (as audited by Sherb) raise numerous red flags. As of the September quarter (prior to the Chairman’s cash injection), Cleantech reported just $960,000 in cash. Yet it has a receivables balance of over $10 million. It has also reported “prepaid expenses” of $1.7 million.

So investors are left to wonder why a company with almost no cash on hand is advancing millions of dollars to both its customers (the receivables) as well as to its suppliers (prepaid expenses).

A company’s cash balance is the easiest item within the financial statements to verify. As a result, investors are aware that companies who commit fraud are forever in need of accounts which let them state large and growing revenues, but which do not require them to prove the existence of cash. This is why Geoinvesting requested to verify the company’s cash balance. Yet Cleantech refused this request.

Separately, Cleantech disclosed that:

Research and development costs are expensed as incurred.

The Company did not incur any research and development expense in 2012 and 2011.

This is a glaring red flag to any investor who wonders how Cleantech could possibly have entirely transformed its very high tech business 4 times in the past 3 years.

Cleantech went from being a high tech windmill component manufacturer, to that of a high tech solar component manufacturer, to that of a “high and low temperature dyeing and finishing machinery for the textile industry”, and now (in just the past week) to suddenly being a supplier of precision components to China’s largest oil companies.

Even if the company had been spending millions in R&D, each of these transitions would have been formidable accomplishments. And yet Cleantech has spent precisely nothing on R&D for the past 3 years.

The margins are yet another cause for suspicion. It is well known that Chinese manufacturers of solar and wind power components have nearly competed each other out of business. Many of these companies are now selling at gross margins which are close to (or even below) zero. Yet Cleantech continues to report massive gross margins of around 23%. A comparison with any of the other major Chinese suppliers would suggest that such a competitive feat is quite literally impossible. This is especially true for such a small company which operates without any meaningful economies of scale. Cleantech reported that 55.8% of its revenues came from forged rolled rings and components (including to the wind power industry) while 44.2% of its revenues came from dyeing and finishing equipment.

Conclusion

Cleantech Solutions has been repeatedly pumped as a “multi-bagger” stock by various parties over the past year. The ultra-low float of just 2.67 million shares means that any spark of news or hype can send the stock soaring within hours. Yet in each case the stock has quickly retreated back to the $3-4 range where it sits on low volume.

The latest “news” regarding Cleantech’s certification by BCC was just the latest in the series on non-events for Cleantech. The fact that this explosive surge occurred immediately after the filing of an S3 registration statement to raise (a much needed) $5 million should speak for itself.

The market has been pricing this tiny cap Chinese reverse merger as a fraud for years.

While day traders are quick to play the “news driven” pop in the low float stock, it is clear that there are an abundance of red flags which will keep sensible longer term investors from owning the stock, even for just a few days.

Cleantech remains as a Chinese reverse merger with a very part-time, absentee US CFO and a set of entirely nonsensical financial statements.

In all likelihood this stock will fall right back to the $3-4 range within the next week or so, as it has done in the past. This represents a drop of around 50% from the last traded share price.

Disclosure: I am short CLNT. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

TSRO: Netupitant results could roil Tesaro

stock decline

Shares of Tesaro Inc (TSRO) have recently traded to new all time highs and are now sitting at $29.40  The shares have now more than doubled since coming public at $13.50 in June of 2012.

However, a series of near term challenges to its lead drug candidate could see the shares drop back below $21.00 in coming weeks.

The latest leg up for Tesaro has largely been the result of optimism towards Tesaro’s prospects with its cancer drug Niraparib.  Niraparib is a poly (ADP-ribose) polymerase (“PARP”) inhibitor being evaluated for use against solid tumors.

Earlier this year Tesaro announced that it would be taking the drug into phase III trials for ovarian cancer patients.  Last week the company announced that it would also be conducting phase III trials for Niraparib in breast cancer patients.

The progress of the drug into phase III trials along with the large size of the addressable markets for these indications has led analysts to upgrade the stock, causing it to briefly touch above $30.00 before falling back into the $20’s.

Visibility has now increased somewhat with Niraparib, which does in fact merit a higher valuation for the stock.  Yet the fact remains that even if it is ultimately approved, the drug will see no revenues until at least 2017.

For the time being, the only real determinant for the bulk of the value of Tesaro remains its legacy project, Rolapitant.  Rolapitant is a “CINV” drug for treating and preventing nausea and vomiting induced by chemotherapy. It is the reason why Tesaro was founded and why they purchased the rights do develop that drug back in 2009.

The biggest near term threat to Tesaro is that the risk related to Rolapitant is surging even as the upside reward scenario has now dwindled.

Morgan Stanley recently upgraded the stock and assigned a $29.00 target based on the near term prospects for Rolapitant and the new and improved longer term prospects for Niraparib.

With the shares hovering around $29.00, it should be expected that any further good news will have limited effect, while any bad news could send the shares sharply lower.

Leerink Swann also delivered a strong upgrade to Tesaro, briefly sending the stock above $30.00.  Yet the Leerink report failed to included even a single mention of the impending results from Netupitant, which are expected out in the next few weeks.  It also did not take into account the fact that another competing NK-1 antagonist CINV will be going generic before Rolapitant even gets to market.

And herein lies the near term problem.

Rolapitant is a NK-1 antagonist CINV drug.  There is an older class of CINV drugs knows as 5-HT3 inhibitors. These include Anzemet, Kytril, Zofran or Aloxi.   These drugs are currently marketed by Sanofi (SNY), Roche, Glaxo (GSK) and Eisai respectively.

Within the newer NK-1 antagonist category, Rolapitant will compete with Emend which is marketed by Merck (MRK).

Problem number one is that by the time Rolapitant even comes to market in 2015 Emend will already be marketed as a generic drug.  There will be little reason for doctors to prescribe a nearly identical drug at a price which is several multiples higher.

Problem number two is much more severe and could have an impact within the next few weeks.

Swiss company Helsinn recently completed phase III trials of its own CINV, Netupitant, which actually combines the action of an NK-1 and a 5-HT3.  Because Helsinn is not a public company, analysts have largely ignored the market potential for this new drug. However, when it is mentioned, they have expressed a positive outlook for Netupitant’s results from phase III.

The reason that this is a near term problem is that ASCO is set to meet in Chicago in May.   Helsinn is also set to attend the Jefferies health care conference on June 3rd.  It is likely that one of these venues will be used to announce the results of the Netupitant trials. Results are widely expected to be positive. In fact, results may also be released even before the ASCO meeting.

The catch-22 for Tesaro is as follows:

If the results were to be unexpectedly poor, then there would likely be no boost to Tesaro given that the stock is fully valued and success of Rolapitant is already priced in.  If the results are (as expected) quite positive, then the impact on Tesaro and Rolapitant should be expected to be quite severe.

Doctors who prescribe a CINV will then have 3 clear alternatives from which to choose.

  1. Choose from one of the many existing 5-HT3’s.
  2. Choose a newer, yet generic NK-1 (Emend)
  3. Choose a combined therapy NK-1 / 5-HT3 (Netupitant) which has no generic

Electing to prescribe a non-generic NK-1 (ie. Tesaro’s Rolapitant) clearly does not fit into any of these sensible alternatives and it raises the prospect of Rolapitant effectively going straight to generic.

It also needs to be remembered that Rolapitant has not yet been approved, even though Tesaro’s share price seems to trade as if approval (and market acceptance) were already guaranteed.

Aspara Biotech Research recently put out a report on Tesaro that took an extremely dim view of Rolapitant’s prospects for phase III approval.  It noted that the rights to the drug had originally been purchased by Opko Health (OPK) for just $2 million at a time when Schering-Plough had already discontinued development of the drug.  At that time, 2008, phase II trials had already been completed. Tesaro then paid a very small premium above that $2 million to acquire rights to the discontinued drug.

As noted by Aspara, Opko had disclosed in its 10K that

Development of Rolapitant and the other assets had been stopped at the time of our acquisition and there were no ongoing clinical trials. None of the assets acquired have alternative future uses, nor have they reached a stage of technological feasability.

The apparent reason for this halt in development was that results from phase II had been quite marginal.  There was therefore substantial room for doubt regarding an ultimate phase III approval. As a result, Schering-Plough discontinued work on the drug before selling it for almost nothing.

The results of the trial were just barley significant at the 5% level (p value of 4.5%) and the results also coincided what appears to be a statistical aberration in the placebo arm. In other words, even though Rolapitant appears to have received an artificial boost to its observed effectiveness (a clear advantage), it still just barely achieved statistical significance.

The conclusion from this is that there is in fact a much higher than normal likelihood that the marginal statistical significance seen in phase II will reverse itself when shown in phase III results.

Once again, it is the case that there is little remaining upside to a successful phase III.  But in the event that the phase II results do reverse themselves following the marginal phase II study, the results will be negative to the extreme.  It would then be the case that the value of Tesaro would be solely dependant upon its other two drug candidates.  Neither of these is expected to produce revenues until 2017-2019.

As a result, if Netupitant posts positive results in May, then we can expect to see the share price quickly retreat back to around $21.00.  But if the very marginal Rolapitant then fails its phase III later this year, then the share price certainly falls into the teens, down around 50%.

The body language coming out of Tesaro suggests that the company is aware of this quickly impending problem.  Tesaro appears to be de-emphasizing Rolapitant in case the drug either fails in phase III or else can’t compete with generic Emend.

In March, Tesaro raised $95 million ($91 million net of underwriting commissions) via an equity offering at $18.00, around 40% below current levels.  At the time the company still had $125 million in cash, such that there was no pressing need to raise new money. In addition, there was no specific use of proceeds disclosed in the prospectus. Tesaro disclosed that

We anticipate that we will use the net proceeds of this offering to fund our development programs, including clinical trials for our product candidates, for working capital and for general corporate purposes.

 

We may also use a portion of the proceeds to in-license or acquire, as the case may be, product candidates, technologies, compounds, other assets or complementary businesses, though we have no current understandings, agreements or commitments to do so.

The result of this offering is that Tesaro now has a very healthy cash balance of $198 million, equating to $6.10 per share.  When the price was still at $18.00 this meant that there was actually a very significant downside cushion for investors in the stock.  However with the stock now hovering near $30.00, this $6.10 in cash per share offers minimal downside cushion.

But it should be clear from this offering and its disclosed use of proceeds that Tesaro is attempting to diversify away from Rolapitant.  It should also be clear that Tesaro hasn’t even decided how it will specifically do so.  Instead it is just raising money while the share price will allow it.

This should certainly have been even clearer for anyone who listened to the last quarterly conference call. Hopefully it did not escape the attention of listeners that Tesaro mentioned

Enrollment continues in each of our three Phase 3 trials of Rolapitant.

As shown at ClinicalTrials.Gov, Rolapitant was originally scheduled to conclude its phase III trials by December of 2012.  The trial has been enrolling at 200 sites around the world.  Yet they have not even been able to complete enrollment and it is 5 months past the scheduled completion date.

Rolapitant is currently undergoing multiple phase III trials which are scheduled to release top line data (only) later this year.  In addition, Rolapitant is the only near term revenue candidate for Tesaro.

Yet despite this critical importance to Tesaro, on the conference call we can see that any discussion of Rolapitant is limited to a few brief paragraphs.   The focus of the call is then entirely switched to Niraparib and TSR-011, neither of which has any revenue potential for at least 4 years.

Conclusion

In evaluating these developments, one must remember that Tesaro is entirely dependent upon Rolapitant for any revenue potential within the next 4 years.  One must also remember that the phase II results for Rolapitant were in fact quite marginal.

Phase III trials for Rolapitant are now being repeatedly delayed as enrollment continues well beyond the deadline.

First, this does not bode well for the overall results of Rolapitant in phase III.

Second, even the mere delay of phase III results is highly problematic for Tesaro.  This is because the delay will negatively impact Tesaro’s ability to actually sell the drug due the Emend going off patent as well as the coming launch of Netupitant.

As a result of these factors, Tesaro is clearly trying to position itself as a company which has other alternatives and opportunities beyond Rolapitant.  The company is raising money without a defined use of proceeds and is de-emphasizing Rolapitant in its conference calls. In short, Tesaro is well aware of the impending problem, even though investors are not.

It remains the case that at least 80% of the value of the share price is a function of the prospects for Rolapitant.  Even optimists do not predict Niraparib revenues until 2017.

As a result, when Helsinn releases results for Netupitant in the next few weeks, Tesaro shareholders should expect a volatile ride with the share price potentially heading back to below $21.00 where it began the month of April.

Investors also need to keep in mind that over 18 million insider shares of Tesaro were locked up due to the recent equity offering.  This lockup  expired on April 28th, just in time for the shares to hit all time highs.  Yet this is also just in time for selling to be possible just as Netupitant results are coming to market.

TEAR: Stock to drop on stock offering

tear drop crying eye

Shares of TearLab (TEAR) have nearly doubled in 2013, buoyed by a stream of analyst upgrades from small, retail oriented brokerages. However, it now looks as if a near term equity offering will likely take the shares lower.

Investment thesis

Despite the recent bullish analyst reports, financial performance at TearLab has been consistently very poor. The company’s balance sheet continues to be weak and the company has lost money every year in its history. The company will clearly need to issue a sizeable amount of equity at a price of around $6.00 or below.

The bullish upgrades from sell-side analysts suggest that the equity offering could be expected very soon. The upgrades have so far been based on very dated information from the 1990s which has now been repeated.

In addition, there are fundamental problems with TearLab’s product offering, which will severely limit its ultimate adoption by eye doctors. Although the test works well, it is ultimately not a necessary diagnostic for eye doctors. Finally, the total market size for dry eye disease is far less than what has been forecast.

TearLab’s financial performance

TearLab has continued to post slight increases in revenues, but only via larger increases in marketing expenditures. The net result was a net loss that widened to $19 million in 2012. Over the course of its 10 year life, TearLab has never once made a profit.

In contrast to the bullish sentiment expressed by analysts, TearLab’s latest 10K filing discloses quite clearly that

 

Our limited working capital and history of losses have resulted in doubts as to whether we will be able to continue as a going concern.

 

As of December 2012, TearLab had $15 million in cash, but lost $19 million for the year on a mere $3.9 million in sales. This puts the company on a Price to Sales ratio of more than 50x.

The company indicated on its last conference call that it hopes to more than double revenues to $9 million in 2013. But once again, the revenue growth will only be made possible by spending “a couple of million more” than that $9 million on marketing expenditures. So once again, TearLab will post an ongoing net loss.


(Click to enlarge)

Will TearLab issue equity soon?

TearLab has been a serial dilution machine, offering equity inevery single one of the past 10 years. In many cases the company has offered equity multiple times each year. In numerous cases the deals required heavily dilutive warrant coverage.

During the past 2 fiscal years alone, TearLab has issued equity 7 times raising nearly $40 million. The average price for issuing equity was just $2.35 – roughly 70% below the current level.

Date Shares Proceeds Share price Warrants
Jan 2010 3.2m $3.0 m $0.93
Mar 2010 1.5m $5.0 m $3.22 621,000
Jun 2011 1.6m $2.1 m $1.60 109,375
Jun 2011 3.8m $7.0 m $1.82 3,846,154
Apr 2012 3.5m $12.4 m $3.60
Jul 2012 2.5m $7.9 m $3.17
Sep 2012 0.3m $1.2 m $3.72
Total 16.4m $38.6 m 4,576,529
Avg $2.35

It is clear that TearLab needs to issue equity again, likely in the next few weeks. The recent bullish report and $8.50 share price target from Craig Hallum came with a disclosure that:

 

Craig Hallum expects to receive or intends to seek compensation for investment banking services from the subject company in the next three months.

 

This makes the timing of the analyst attention very fortuitous. Yet it is quite likely that the offering will occur far sooner that 3 months. It is likely that the timing will be in the proximity of its next earnings release date, which is expected in about 2 weeks.

At what price will TearLab issue equity?

The analyst upgrades have been very effective in getting the share price up to all time high prices. Of equal importance, the upgrades have also generated significant spikes in volume.

The low trading volume is a problem for TearLab and is one of the reasons why the company has been forced to issue heavily dilutive warrants in the past.

On Monday April 22nd, brokerage Craig Hallum upgraded the stock based on brief comments which had been made at an ophthalmology conference. Hallum was exceedingly bullish and their remarks had a predictable effect on trading volume.

TEAR 5 day volume
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The volume is very important here because TearLab will need to raise at least $20 million in proceeds. With pre-upgrade volume hovering at around 100,000 shares per day, such a deal would require nearly 6 weeks’ worth of trading volume to be issued in a single day. A deal of that size would likely be accompanied by heavy warrant coverage or a discount to the share price of roughly 20%.

Unfortunately, the volume effect of these analyst upgrades is short lived. We saw similar volume spikes to as high as 900,000 shares per day on previous analyst upgrades. In each case the volume subsides once the upgrade becomes old news.

As a reference point, last week Craig Hallum ran an equity offering for Unipixel, which has a market cap of $350 million. That deal came with a 20% discount due to its low float. The share price immediately traded down 20% to the stock offering price, as expected. The equity offering came very shortly after Hallum had raised its share price on Unipixel by almost 100% to $58.00. The share price fell to $32.00 on the offering.

For TearLab, this would imply that the offering price (and thus the share price) would be headed to around $5.75-6.25.

What is the basis for the upgrades?

Craig Hallum released 3 very brief paragraphs to justify how TearLab has suddenly become an $8.50 (target price) stock.

 

Our observations at this year’s ASCRS meeting (which kicked off in San Francisco this past weekend) made a strong case that physician acceptance of the TearLab System as the gold standard for testing of Dry Eye Disease has reached a tipping point and that near term mainstream adoption is likely.

 

A paper posted on the website for the National Institute of Health (“NIH”), and also posted on TearLab’s own website, is entitled “Tear Osmolarity – A New Gold Standard“.

Unfortunately, the “gold standard” paper was dated from 1994 – almost 20 years ago. Yet this transition to “gold standard” in the 1990s has not resulted in commercial success for TearLab’s osmolarity product in these 20 years.

Had they not been so heavily highlighted again by Hallum, these comments would certainly not have moved the stock.

Justifying the share price target

Craig Hallum is the odds-on favorite to be the investment banker for a TearLab equity offering. Within Craig Hallum’s coverage universe, 74% of companies are rated “BUY” while 25% are rated “HOLD”. Just 1% of the companies are rated at “SELL”.

The firm’s recent upgrade and $8.50 target resulted in a very noticeable boost to both the share price and the volume. The share price now sits just a few percent below this target, which is at a lifetime high for the stock. It is also roughly double where the stock began this year.

In order to justify this stratospheric target, Hallum predicts that after years of struggling to break above $1 million per quarter, TearLab will suddenly catapult to $40 million in annual sales during 2014. This will be a particularly steep trajectory following another year of wide losses in 2013.

Yet the financial model in the Hallum report indicates that in 2014 TearLab will still be losing money even if revenues hit $40 million. It also indicates that TearLab will not issue any equity (even though it is undeniably needed) in either 2013 or 2014.

On page 5 of the recent report, Hallum includes a valuation comps table which puts TearLab at a 12.2x multiple of EV/Sales.

Ticker Company Price CY’13 EPS EV/’13 Sales
CPHD CEPHEID $38.06 $0.01 6.4x
CPTS CONCEPTUS $25.56 $0.23 5.0x
CYBX CYBERONICS $44.80 $1.83 4.1x
DXCM DEXCOM $15.50 ($0.54) 8.1x
EW EDWARDS L.S. $83.12 $3.27 4.3x
ELGX ENDOLOGIX $14.14 ($0.14) 6.4x
GNMK GENMARK DIAG $14.71 ($0.80) 12.2x
ISRG INTUITIVE SURG $484.75 $17.64 6.4x
MDXG.PK MIMEDX GROUP $5.00 $0.00 7.8x
NEOG NEOGEN $49.85 $1.23 5.1x
PODD INSULET $26.23 ($0.59) 5.8x
SRDX SURMODICS $26.75 $0.87 6.1x
SPNC SPECTRANETICS $19.51 $0.01 4.2x
Median 6.1x
Average 6.3x
TEAR TEARLAB $7.34 ($0.42) 12.2x

This makes it a tie for the single most expensive stock within the medical technology comp group. It also makes it double the average multiple within that group. Yet the “BUY” rating persists.

Why won’t eye doctors make use of TearLab’s osmolarity system?

TearLab’s osmolarity system faces fundamental obstacles which continue to limit its adoption by eye doctors.

TearLab officially launched its product in 2008 and began commercialization and marketing of the product in 2009. Yet 4 years later, the company is still only attaining around $1 million in quarterly sales.

The point is that this is a product that has been well recognized and understood, and has been heavily marketed for years. Yet it continues to face dismal adoption rates by eye doctors.

The system works quite well and dry eye specialist doctors love it. However, for the other 50,000 eye doctors in the U.S. (i.e. TearLab’s intended target market), there are fundamental issues with the system that virtually preclude its wide spread adoption.

TearLab’s osmolarity system has three components. There is a microchip tear collector, a pen device for administering and a desktop unit for analyzing the tear. The output from this process is a numerical score which quantifies the patient’s condition within a dry eye score range.

TearLab (and the analysts) have correctly noted that the products come with a roughly 50% margin for the doctors who sell and administer it. This would seemingly make it attractive to eye doctors within their practices.

Yet the reality is that TearLab sells the diagnostic chip for just $10-15 while doctors get reimbursed at a rate of $22.71. So what we’re really looking at is an opportunity for a doctor to only make an extra $10 or so.

In order to make the extra $10, the doctor must acquire and make use of the desktop system and train his employees in its use.

The reimbursement requires a CLIA waiver and each doctor’s office must receive their own specific FDA waiver. Some states (such as New York and Nevada) do not even allow optometrists to receive waivers at all, precluding the use of these tests in point of care settings entirely.

In addition, many insurance providers do not reimburse for these tests which further reduces their use. In the event that reimbursement is able to be provided, pre-authorization by the insurance company is required.

Given that these tests are typically conducted as part of routine visits, the pre-authorization means that patients would be required to make a second visit in order to receive this test.

This is a fair amount of time and hassle to go through for a doctor. The extra $10 may not justify the extra time that taking such a test entails vs. the time it takes away from other patients.

But is the test necessary or useful ?

If the test were necessary or useful, then its low price point would likely not be an issue for eye doctors.

But the reality is that in the vast majority of cases, non-specialist eye doctors continue to use a simple verbal assessment from the patient to determine if the patient has a dry eye condition.

Once again, we can basically see that this has been the case due to the minimal sales generated by TearLab after 4 years on the market.

A dry eye study from the NIH noted that an overwhelming 82.8%of dry eye cases were diagnosed by doctors using simple “symptom assessment” alone. What this means is that eye doctors are less concerned about the numerical score revealed by a tear osmolarity test than they are about simply hearing the patient describe their symptoms. Even though TearLab’s product can be described as accurate, it is also largely unnecessary.

Think of it this way: if a doctor had to go through a significant amount of time and hassle to provide a flu patient with a numerical score to quantify his flu symptoms, he would most likely not do so. The chance to make an extra $10 would likely not add any additional encouragement either. Instead, the doctor would continue to simply ask the patient his about his or her symptoms and offer treatment based on the diagnosis.

In short, this explains why the test has not been adopted after years on the market: it is a largely unnecessary test which also provides almost no economic benefit to the practices of eye doctors.

So who is currently making use of the test?

There are a small number of doctors, as quoted by Craig Hallum, who are very enthusiastic about tear osmolarity. These are doctors such as Dr. Christopher Starr, Dr. Marguerite McDonald, Dr. Stephen Lane, and Dr. Eric Donnenfeld.

These are doctors who have made a specialty of dry eye disease. Their names appear frequently on sites such as “TheDryEyeReview.com“. They have also appeared in very positive comments and articles on TearLab’s website. They have been vocal supporters. As specialists, the ability to generate a numerical score to quantify the effects of dry eye is clearly something of professional interest.

But within the larger market of 50,000 eye doctors in the US, they have proven (for 4 years running) that they are less interested in seeing an academic, numerical score than they are in simply delivering treatments to their patients who they can already tell are suffering from dry eye.

These are the same doctors who have been vocal supporters on TearLab’s website since 2009. This makes it odd that Craig Hallum would extrapolate so heavily from their continued support again in 2013.

The REAL market size for dry eye is far smaller than TearLab estimates

TearLab management has indicated that there is a $1.8 billion market for their product. This is a huge number and is what has kept management trying to succeed. It is also what has kept investors willing to hold the stock despite the ongoing losses.

Yet from management’s presentation, we can see that this description of “market size” is far too expansive.

It is based upon an assumption that:

a) all 50,000 U.S. eye doctors (ophthalmologists + optometrists) will

b) see 6 dry eye patients every single day

c) they will do so on all 250 business days per year

d) they will be tested a cost of $12.00 per eye ($24 per patient).

This equates to 75 million patients every year. Again, this is a huge number and it is one that those who specialize in dry eye would certainly like to see.

Yet on page 9 of the same presentation, we can see that the total number of actual dry eye cases in the U.S. is only estimated at 30 million.

What this means is that there is capacity to treat 75 million cases of dry eye, but far less actual demand for dry eye tests and treatments. These numbers are according to managements own data.

Yet even management’s current estimate of total dry eye cases appears to be significantly too high compared to objective observations. The 30 million estimate comes from two studies that date back to the 1990′s (see footnotes 7 and 14).

According to a more recent study posted at the National Institute of Health entitled “Prevalence of dry eye disease among U.S. men“,

 

The age-standardized prevalence of DED was 4.34%, or 1.68 million men 50 years and older, and is expected to affect more than 2.79 million U.S. men by 2030.

 

Page 9 of TearLab’s own presentation also confirms that dry eye is mostly prevalent in older segments of the population, and even TearLab includes no data for those under 45.

Using the NIH data, and assuming that women are equally at risk of dry eye, yields around 6 million total dry eye cases per year, which is far below the 30 million estimate still used by TearLab management.

In short, this explains why TearLab’s revenues have so far been struggling to break roughly $1 million per quarter, despite being on the market for its 4th year.

Conclusion

The low price point and limited market need for tear osmolarity tests means that the only way for TearLab to continue generating sales is to continue with a heavy marketing spend. This need almost entirely precludes TearLab from generating a profit in coming years. The company has already disclosed that it will continue to incur heavy losses again in 2013 and even bullish brokerages predict continuing losses for years to come.

Recent NIH estimates indicate that there are only around 6 million applicable patients in the U.S.

If TearLab tests were used on 100% of all patients in the US then total revenues would be just $120 million. TearLab’s current market cap is double the entire market size.

The stock has nearly doubled in 2013 due to analyst upgrades from brokerages who are eager for investment banking roles.

The catalyst for a decline in the stock will be its next equity offering which will likely need to occur at a price of around $6.00 or below due to the poor liquidity of the stock.

Once the offering is out of the way and the analyst upgrades fade, it is unclear what will support this stock at $6.00 given that there is no prospect for profitability over the next few years.


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OPK: The Insider Cliff

cliff

Disclosure: I am short OPK(More…)

When I first raised the alarm about Ziopharm Oncology (ZIOP), I received death threats and threats of lawsuits from many retail investors. Some of these can still be found posted online. Many retail investors were so enthralled with this “guaranteed winner” that any suggestion to sell by anyone at any price was shouted down as being illegal manipulation.

I continue to believe that Ziopharm was a tragedy in waiting, and that retail investors never even stood a chance. Yet the stock quickly rose by as much as 25% even after I made my findings public. Following its collapse from near $6.00 to well under $2.00, I wrote an article entitled “Ziopharm: Why retail got slaughtered.” As has been the case in the past, I received a small number of “thank you” notes and an even smaller number of apologies. These are always meaningful to me.

Opko is a different company, with a different management team, a different billionaire investor and a different portfolio of products. But several readers of my most recent Ziopharm article quickly pointed out that the retail situation is entirely identical to what is now happening at Opko Health (OPK).

Like Ziopharm, Opko has an intensely loyal following of retail cheerleaders who constantly state that the right time to sell Opko is “never.” A small number of very vocal readers will no doubt reject all of the findings that I put forth in this article. Yet the parallels are quite clear.

Even Opko bulls admit that the stock is tremendously overvalued. Institutions refuse to own the stock, holding just 14.9%. Meanwhile, retail investors continue to chase the stock upward under the belief that continued purchases by billionaire Dr. Phil Frost mean that further upside is nearly guaranteed.

The problem is that (just like with Ziopharm), the recent purchases by the billionaire are so small that they do nothing to change his overall in price of just $2.99. If Opko falls to $4.00, Frost will make over $150 million, while retail will lose 45% of their money. Retail had also pushed Ziopharm to its limits following small purchases by billionaire investor Randal Kirk at over $5.00. But with his much lower basis at just $1.91, Kirk lost almost nothing when the heavily-shorted stock ultimately collapsed to $1.84.

Institutions are no doubt aware of these small and steady purchases by Dr. Frost, yet they continue to prefer to be short the stock rather than go long. Short interest current stands at $200 million.

The problem here is not Opko itself and the problem is certainly not Dr. Phillip Frost. Most would agree that Opko has now assembled a very interesting portfolio of healthcare products including medical diagnostics and Phase III drug candidates. The real problem is that, like Ziopharm, the price is now about 50-60% above where it should be, given the company’s current business prospects.

From a practical standpoint, the bigger problem for investors is that Opko’s string of acquisitions has created a group of entrepreneurs in multiple foreign countries who now own over $300 million of the stock. These entrepreneurs are now “insiders” but are not part of Opko core management and they are now sitting on tremendous paper gains right as their shares are becoming sellable.

For example, with Prost-Data, Opko delivered over 7 million shares of stock when the price was sitting at $4.33. The seller realized plenty of profit at $4.33, but is now sitting on additional paper gains of nearly 70% in just 6 months, totaling roughly $20 million. That transaction was completed in October, such that under rule 144, the shares will become sellable on or around April 18th, which is now quickly approaching.

As we know, there have been numerous other transactions completed in recent months, just prior to the tremendous surge the stock had. As these transactions start resulting in sellable stock, retail will face up against an “insider cliff.” Opko has issued over 37 million shares to non-management entrepreneurs who sold their businesses to Opko.

Recent developments probably make Opko a decent buy at around $5.00 or even perhaps slightly above. But with the stock hovering at levels 40% higher than that in just a few months, it is highly likely that we will soon start seeing the first sell prints from non-management insiders.

The last sale by an insider of just 50,000 shares took the stock quickly back down to $6.10. As a result, there may well be very good opportunities in the near term to buy on a pullback at prices in the $5.00-$6.00 range. Even Cramer, who loves the company, continues to describe the stock itself as “very speculative” and suggests that buying should come on a pullback in the stock.

It is likely the case that the upcoming release of 7 million shares has been the cause for the recent volatility and several steep drops in Opko’s share price. On April 3rd, 1.6 million shares were quickly sold at a price of $6.80, and we have now seen 7 steep drops (highlighted below) for no apparent reason.

Institutions will be well aware of the upcoming insider cliff, even as retail investors are not. And selling ahead of any upcoming sale of shares is sensible, just as it is when selling ahead of IPO lockup expirations.

(click to enlarge)

What do we mean by “huge”?

Dr. Frost has an enviable track record in making healthcare investments. He has demonstrated the straightforward wisdom of buy low, sell high.

Many retail investors view the weekly buying by Dr. Frost as being “huge,” “tremendous” or “enormous,” Relative to the purchases of retail, the buying does appear to be sizable. Some of his larger recent purchases have even exceeded $500,000 in a single day. $500,000 certainly appears to be a large sum to retail. Yet relative to his historical purchases (now worth over $1 billion) at far lower prices, these new buys are so small that they have virtually no impact on his in-price or his position size. This is nearly identical to what we saw with billionaire Randal Kirk’s buying in Ziopharm.

As we can see in the chart below, Dr. Frost has conducted the largest portion of his buying in the $4.00-$5.00 range. All combined, purchases above $6.00 are so small that they almost do not even show up on the graph. Purchases above $5.00 are also negligible.

(click to enlarge)

Dr. Frost began buying into Opko when it was known as eXegenics. The initial transaction was for $8.6 million to buy roughly one half of the company, translating to 44 cents per share. Dr. Frost has purchased 80 million shares at below $2.00 (much of it below $1.00). All transactions, including the recent ones, at above $5.00 total only 6 million shares.

The result of this is that his overall in-price is just $2.99 – more than 60% below the current prices where he continues to nibble.

This means that Dr. Frost’s return profile vs. retail (purchasing now) is as follows:

Stock price Dr. Frost Profit Retail’s Loss
$3.00 Breakeven -58.9%
$4.00 $151 million -45.2%
$5.00 $301 million -31.5%

Dr. Frost will still be able to make hundreds of millions of dollars on this position even in the case where the current purchasers suffer very steep losses. As with Randal Kirk in Ziopharm, this is why Frost is a billionaire. And as with Randal Kirk, the continued buying in small size serves his own interests very well.

The insider cliff

When I last wrote about Opko, I noted that insider selling had begun. As did Ziopharm, Opko responded forcefully to my article. And as with Ziopharm, the share price rose dramatically on their press release.

The biggest problem with the press release was that Opko stated that:

 

No other sales by Company officers or insiders are currently contemplated.

 

The problem is that the term “insiders” now comprises a far larger group of individuals than Opko’s core management. Opko has now completed numerous acquisitions in countries such as Chile, Mexico, Brazil, Israel, Spain, Canada and the US. In most cases, these acquisitions were completed by issuing Opko shares to the founders of the targets.

In “contemplating” further insider sales, it seems unlikely that Opko could have received much clarification from these numerous other insiders in various foreign countries during the 2 hours prior to putting out a press release.

We can see that the term “insiders” now comprises a far larger group than Opko management. The table below shows recent Opko acquisitions along with the number of shares issued.

Name Country Shares issued
Cytochroma Canada 20,517,030
Prost-Data USA 7,072,748
Farmadiet Spain 125,000
Finetech Israel 3,615,702
Claros USA 4,494,382
Pharmacos Exakta Mexico 1,372,428
TOTAL 37,197,290

We can see that the total is 37,197,290 shares valued at nearly $300 million. This is not Opko’s money, this is money that is now waiting to end up in the pockets of the entrepreneurs in various countries who sold their companies to Opko. We can see that many of these holders are now sitting on tremendous paper gains - even after the gains they made from the initial sale at then-prevailing prices for the Opko stock they received.

Under Rule 144, we will see that the first chunk of stock will become freely sellable in less than 2 weeks, and comes from Prost-Data whichreceived stock at $4.33.

With CytoChroma, we have a bit longer to wait, but the number of shares which can hit the market exceeds 20 million shares and the gain for the seller is now nearly $50 million – even after the gain on the initial sale. This could be part of the reason why we are now seeing increased volatility and sharp drops in the share price of Opko lately.

Why won’t institutions buy Opko?

Even more so than Ziopharm, we can see that the shareholder base in Opko consists almost entirely of retail investors. Institutional investors are neither blind nor dumb. They are just as capable of reading the “Latest Insider Buys” headlines. Yet we can see that institutions only hold tiny 14.9% of Opko stock.

There are several reasons why institutions are refusing to buy into Opko. First, the company has swelled to a $2.5 billion market cap, precluding making any reasonable profit on the stock vs. its near-term prospects.

Opko currently trades at over 60x Sales. This makes Opko one of the most expensive stocks to own among all healthcare stocks. Even if Opko starts to generate material revenues sometime later in 2013, the company is several years away from generating the type of profit that could justify this valuation. Even once Opko generates a profit of $100 million (vs. the current loss of $10 million) the company would still be trading on a healthy 25 P/E. This is likely to be years away.

Second, institutions have come to learn that Opko is looking to be a perpetual “deal and dilution machine.” Every time Dr. Frost issues another 10-20 million shares in an acquisition, it only further raises the bar for profitability because the market cap becomes that much larger. Most investors expect a continued string of deals, particularly given the sky high share price. Third, Opko has become a collection of disparate and distinct healthcare business ventures which makes it nearly impossible to value the company. It more closely resembles a VC company, which should be valued at a much lower multiple.

The only thing that institutions can currently be certain of is that Opko is tremendously overvalued. But they can’t even determine by how much due to the wide variety of unrelated businesses which Opko has now purchased.

No one knows how to properly value Opko, but they do know that the past acquisitions strung out over 3 years have still not produced meaningful revenues or any profit whatsoever – even though past expectations by retail were also very high at the time the deals were announced.

Lastly, institutions may likely have much larger reservations that retail investors regarding the longer-term risk of investing in a very richly valued “one man show.”

Right now the sky-high value of Opko stock is attributed solely to the current level of involvement by Dr. Frost. At age 77, Dr. Frost has had a much longer career than most and if there is any sign that his involvement in Opko looks to decline even modestly, then the share price could potentially trade at a significant discount to the value of Opko’s underlying business portfolio. Relative to the current “Dr. Frost premium” this could create tremendous downside. The eventual non-involvement by Dr. Frost is clearly inevitable, but the timing of it remains entirely unpredictable which keeps institutions out.

Retail investors need to ask themselves the downside question of what Opko is worth as a freestanding company, assuming little to no involvement from Dr. Frost. That is the downside scenario that institutions are unwilling to bear.

In any event, we can see clearly that for a wide variety of reasons, investors simply refuse to own Opko even despite its investment-worthy size of $2.5 billion.

Instead, institutions are SHORTING Opko

We can see that Opko is now a very sizable company and the institutions which choose to be involved express their interest preferably on the short side. Currently, there are nearly 28 million shares of Opko sold short amounting to nearly $200 million.

Again, short selling institutional funds are also neither dumb nor blind. They are well aware of the steady trickle of headline-grabbing purchases by Dr. Frost.

As with Ziopharm, short selling institutions love Opko as a short and they have committed to their short position in a very large size. When institutions refuse to go LONG but are extremely enthusiastic about going short, retail investors need to ask themselves if they really feel that they have an informational advantage which justifies chasing the stock to ever higher levels.

It should also not be lost on retail investors that the huge short interest in the stock has been present ever since the stock was at $4.00-$5.00, roughly 40% below current levels. It was also the same level where short reports began in earnest regarding Opko’s prospects and valuations.

It also happens to be where I suggested the stock could now be considered a “buy” in my last article. The $4.00-$5.00 level remains the right price to be buying Opko shares, but doing so means waiting for some period of time until the stock corrects – i.e., as Cramer said on Friday, “buy on a pullback.” Investors can also stay short the stock through a correction, effectively playing both sides of the trade.

Since the $4.00-$5.00 range, Opko has had several new developments, including the CytoChroma acquisition and the RXi (RXII.OB) pooling of assets. Yet the value of Opko as a company has exploded upwards by an additional $1 billion since December. Regardless of whether one is long or short, it is clear that these developments do not in any way justify an extra $1 billion. As a result, the conclusion by institutions is that despite the recent developments, the rise in the share price simply makes Opko now more overvalued than ever. At any prices above $6.00, Opko is still a compelling short and the institutions know it. At prices of $4.00-$5.00, the stock becomes a buy. While in the $5.00-$6.00 range, it is just a “wait and see” for next results.

Evaluating current business prospects

4KScore

When I last wrote about Opko, I tried to inject a dose of reality regarding the prospects for Opko’s 4KScore test for prostate cancer. In Opko’sresponse, which drove the stock higher, they notably did not challenge any of my concerns.

As I previously stated, investors need to realize that 4KScore cannot generate even a fraction of the many billions projected by a small number of authors. We know that 4KScore could begin to produce respectable near-term revenues, but we also know that virtually all investors and analysts attribute the vast majority of Opko’s $2.5 billion valuation to the prospects of only 4KScore. It is the only near-term material revenue candidate.

In many cases, we can see that these projections have been issued after the rise in the stock, in an attempt to justify the valuation rather than predict what it should be. In forecasting many billions in 4KScore revenues, these projections were based on securing a tremendous market share (as high as 50%) even while incorporating a price which is nearly triple what other tests go for.

Since the time of my last article, The New York Times has begged to differ with the bullish forecasts for 4KScore dominance. The Times noted that:

 

More than a dozen companies have introduced tests recently or are planning to do so in the near future. Rather than looking at a single protein like P.S.A., which stands for prostate-specific antigen, many of these tests use advanced techniques to measure multiple genes or other so-called molecular markers.

 

The Times also noted that total spending related to prostate screening was around $12 billion. We still need to wait for the first sales of 4KScore to begin in the US. If it turns out that 4KScore is in fact more successful than any of the many alternatives, even then the revenue projections provided by many Opko uber-bulls, will come in at billions less than forecast. It has the potential to be a very successful product, but investors need to recognize the reality of this market.

RXi Pharmaceuticals

In March, Opko completed the pooling of assets with RXi in which it contributed all of its own RNAi assets in exchange for shares of the Pink Sheets listed company. The RXi trade could provide longer-term benefits to Opko, but investors need to be aware that any benefits in the near term (3-5 years) are basically out of the question.

While RNAi is an exciting area of biotech, it continues to be the case that the FDA has never approved a single RNAi therapeutic. RXi is a tiny Pink Sheets listed company which was spun out of Galena Biopharma (GALE).

RXi’s CEO recently described its first year in business as “nearly flawless.” Yet he mostly described the fact that the stock has gone up along with the deal with Opko. It had initially traded at 15 cents and subsequently doubled to over 30 cents. But aside from the stock price, it remains to be the case that RXi has only a single Phase I product and pulled in just $100,000 in revenues solely from government grants. The net loss for the year was $26 million.

In short, there is a very clear reason why this company is still on the Pink Sheets. If Opko eventually receives any benefit from RXi, it will be quite a few years away. In other words, the recent run-up in the stock cannot be attributed to RXi.

There are many other challenging details surrounding RXi and Galena, but given that the impact on the valuation on Opko is so small, I will save those for another article.

CytoChroma

The CytoChroma acquisition was completed in February in exchange for 20 million shares of Opko plus up to $190 million of additional milestone payments to be made by Opko. The 20 million shares were initially valued at $100 million, but that value has now jumped to $140 million given the recent rise in Opko’s share price. This has provided a quick gain of $40 million in just 3 months to the selling founder.

With two products in Phase III trials, CytoChroma clearly has greater near-term potential than RXi, but it also remains the case that these are not revolutionary products like those being investigated by RXi. Instead they are simply Vitamin D derivatives which are hoped to be able to treat Chronic Kidney Disease in Stage 3 and Stage 4 status. The total market size for this application is just 8 million patients such that even if one or both drugs passes Phase III, and even if Opko ultimately captures a significant market share, the overall revenue potential over the next three years certainly cannot justify the extra $1 billion in market cap for Opko. Yet some Opko bulls have suggested that these products will generate a staggering $6.5 billion per year in revenues, making it one of the best selling drugs of all time. Again, reality needs to be factored in against the current unlimited optimism.

The point from each of these examples is that the new developments, even though positive, do not come anywhere close to justifying the extra $1 billion in market cap that Opko has added in just a few months. Even Opko bulls agree with this sentiment.

Now that non-management insiders are sitting on over $300 million in Opko stock, the near-term risk is that they will sell the bounce. The sharp selloff after a small sale by Opko’s Chief Accounting Officer suggests that a much larger and faster drop will accompany the first sale by these very large insiders.

So why does Dr. Frost keep buying?

Even since my last article, Dr. Frost has continued buying small amounts of stock, typically in blocks of less than 50,000 shares at a time relative to his position of over 150 million.

If the stock were to go to $14.00, Frost would continue to buy in a steady trickle. If the stock were to drop to $4.00, he would also do the same. Part of the reason for this is that Opko continues to issue an enormous amount of stock for much needed cash and for acquisitions.

Some have likened Frost’s purchases to an “ongoing share buyback,” yet we can see that in 2013, Frost has purchased just 14 million shares even as Opko has issued 45 million shares in the past 3 months via the convertible and the CytoChroma acquisition. Dr. Frost also purchased some of the convertible bond issues for the same reason.

The net result of these transactions is that despite his steady trickle, Frost’s percentage ownership of Opko has actually decreased during 2013. But his purchases have helped to offset his decrease in ownership which has resulted from ongoing dilution to all shareholders.

Anyone who follows Opko knows by now to expect numerous additional acquisitions, and they should also expect these acquisitions for stock. As a result, it is expected that Dr. Frost will continue to buy small amounts Opko stock regardless of the price. But the continued trickle of buys by Frost helps him to simply maintain some of his ownership, not increase it.

But a much more important reason for Frost to continue to buy is the signaling value, which keeps the share price high. This simply provides Frost with a much more valuable acquisition currency for continuing his purchases of other small companies.

A recent Bloomberg article described Frost’s incessant penchant for doing small healthcare stock deals and quoted him as follows:

 

The almost-octogenarian billionaire isn’t winding down just yet.

There are investors to placate, Teva to mend, Opko — and perhaps new companies — to build. Asked why he hasn’t adopted golfing or other hobbies of the superwealthy full time, his face gives way to a faint smile.

“This is what keeps me going,” he says.

 

Conclusion

Dr. Frost is in this business because doing healthcare deals is what “keeps him going” as he approaches his 80th birthday. With a cost basis of just $2.99, he still stands to make hundreds of millions of dollars even at stock prices below $5.00. Dr. Frost is nearly guaranteed to see a successful return from Opko at any foreseeable price.

Yet for the non-management insiders who have been issued over 37 million shares worth over $300 million, making themselves wealthy at a much younger age will likely prove to be more important than completing strings of deals with small healthcare companies.

And for retail investors who are now buying the stock at over $7.00, profit is likely the only objective. These are the investors who stand to lose up to 45% once the insiders start selling.

With a valuation of $2.5 billion, Opko shares are tremendously overvalued. At over 60x Sales, the stock is quite obviously overvalued relative to the current fundamentals. But more importantly, the stock is still tremendously overvalued even relative to the stock’s near-term prospects for 4KScore and its new Vitamin D products which are still in clinical trials. This is the reason why non-management insiders have a major incentive to sell.

Even those who are bullish longs on the stock now quickly admit that the only reason to continue buying Opko is that the continued buying by Dr. Frost makes this “safe.” The huge short interest from institutions continues to contradict this hope by retail investors. Meanwhile, institutions continue to refuse to own Opko on the long side.

As we saw in February, the sale of just 50,000 shares by an insider quickly took the stock back down to $6.00. In advance of the April expiration of the 144 restrictions on Prost-Data, the stock is again showing significant volatility to the downside, and retail is the only one wondering why.

In the near term, there are likely to be opportunities to get back into the Opko story, perhaps at prices in the $5.00-$6.00 range. In the meantime, staying on the sidelines or getting moderately short the stock are the best way to play Opko.

(click to enlarge)

NOW: Analysts Say Buy, As Insiders Dump Stock Early

no dumping
Investment Thesis  
 
ServiceNow insiders have now sold over $400 million of stock even after its IPO, disregarding bullish calls from research firms (who happen to also be its bankers).
 
On February 1st – the first day of the February lockup expiration – the CEO and the company founder began selling large amounts of stock at below $28.00. In the past 8 weeks a wide range of insiders have now sold over $80 million of stock with no sensitivity to price.In November, ServiceNow broke its lockup period early and made use of a JOBS Act exemption to further eliminate subsequent selling restrictions. ServiceNow offered 16.1 million shares at $28.00. The exemption was designed to provide small cap “emerging growth companies” with greater access to financing. There are two problems with this. First, $5 billion ServiceNow is not a small cap company. Second, 88% of the proceeds went to selling insiders and did not provide money to ServiceNow.Such provisions under the JOBS Act have been controversial. A Bloomberg article entitled “Job-Creation Bill Seen Eviscerating U.S. Shareholder Protections” quoted the former Chief Accountant from the SEC as saying:

It won’t create jobs, but it will simplify fraud…This would be better known as the bucket-shop and penny-stock fraud reauthorization act of 2012

By applying for “emerging growth company” status, ServiceNow can opt to disclose fewer years of financial statements. They are exempt from certain disclosures regarding executive compensation. Investment banks love the provision that allows them to publish research prior to their IPOs – a practice which was banned following the dot.com boom and bust.Perhaps of greatest concern is that these “emerging growth companies” do not need to have an auditor attest to their internal controls as required by post-Enron Sarbanes-Oxley.For ServiceNow, the recent 10K discloses that in the 6 month period before the IPO, the auditor found “material weaknesses” in internal controls.For the period after the IPO, it also discloses that

This report does not include a report of management’s assessment regarding internal control over financial reporting or an attestation report of our registered public accounting firm due to a transition period established by rules of the Securities and Exchange Commission for newly public companies.

So before ServiceNow was a public company, we learned from its auditor that internal controls were ineffective. Now that it is a publicly traded company, the company gets to claim an exemption such that no auditor report on internal controls is necessary.Clearly this is what was meant by “eviscerating” shareholder protections.Despite the bullish upgrades from analysts, those who know the company best are selling the most and at every opportunity. At a minimum these large ongoing insider sales will certainly cap the share price. And with roughly 90 million more shares now sellable, there is significant potential for substantial price declines in ServiceNow.In the past, ServiceNow directors and management including founder Frederic Luddy and directors John Moores and Charles Noell, were big early sellers of the their previous venture Peregrine Systems.They pulled in over half a billion dollars from sales of stock – even though these sales had occurred during restricted periods designed to prevent selling by insiders.Selling as early as possible was very fortuitous for these insiders because when Peregrine collapsed due to findings of massive fraud, there wasn’t much left for those who hadn’t sold early.ServiceNow CFO Michael Scarpelli was less fortunate. When his HPL Technologies collapsed due to fraud, he hadn’t sold and the company ended up at 8 cents on the pink sheets. But now it is 2013, and in the past few weeks alone he has sold nearly $5 million of ServiceNow stock.

Analysts say BUY while insiders say SELL

Shares of ServiceNow (NOW) have rallied by more than 40% since their January lows of $26.00. On January 30th the company announced a small beat on revenues by $4 million but the net loss was still running at $10 million. Clearly this was not what drove the rally in the share price.

Instead the stock has been propelled by a wave of analyst upgrades to prices in the $40-43 range. Coverage is currently provided by banks including Morgan Stanley, Barclays, Deutsche Bank, Credit Suisse, UBS, Citi and Wells Fargo. Most investors will be aware that these are the banks involved in ServiceNow’s recent IPO and equity offering.

Clearly insiders are unwilling to wait for the stock to rise the extra 14% to its “full value”. In fact, on the first day of the February lockup expiration, CEO Frank Slootman sold $558,000 of stock, while “Chief Product Officer” and founder Frederic Luddy sold a much larger $12.4 million in stock.

That was on the first day alone, and these transactions both occurred at prices of $27-28. These were the beginning, not the end, of the most recent wave of insider selling that is still going on.

Over the past 8 weeks alone, insiders have now sold over $80 million of stock in a steady stream from week to week.

The list of selling insiders is not short, and includes the President and CEO, the CFO, the founder and “Chief Product Officer”, the Chief Technology Officer, the SVP of Engineering, the SVP of Worldwide Sales and Service and three different directors – who happen to represent the largest institutions that own the stock.

Their sales across various transactions since February 1st can be summarized form Form 4′s as follows:

Insider Role Shares Avg price Proceeds
Luddy Frederic Founder / CPO 465,000 $27.40 $12.7m
Slootman Frank President / CEO 135,000 $31.59 $4.3m
Scarpelli Michael CFO 140,000 $33.92 $4.7m
Josefsberg Arne CTO 200,000 $31.29 $6.3m
Mcgee Daniel SVP Engin. 405,000 $28.99 $11.7m
Schneider David SVP Sales/Srvc 227,410 $32.96 $7.5m
Barber Paul V Director 205,795 $31.29 $6.4m
Moores John J Director 564,397 $36.42 $20.6m
Noell Charles Director 285,100 $32.08 $9.1m
Totals 2,627,702 $31.74 $83,392,041
Hopefully several things are readily apparent from the table above.- The transactions involve basically every senior member of management along with Directors- In each case the individuals are selling large amounts of stock, netting well into seven figures each- The average sale price is just $31.74- The largest block was sold by ServiceNow founder Frederic Luddy at a price of just $27.40 – 25% below the current share price and 33% below analyst targets- There have been no insider buys in 2013Clearly given the large size of the transactions involved, these selling members of management could pull in further gains of millions of dollars each if they were willing to simply hold their shares until they hit analysts’ targets of $41.00.

Yet clearly the ones who know the company best are the ones selling the most, regardless of what the price does.

In actuality, this current wave of insider selling is not the first wave. Back in November, ServiceNow made the following announcement:

ServiceNow Announces Partial Release of Lock-up Agreement with a Director in Connection with Proposed Follow-on Offering and Waiver of Lock-up Extension Provision in Lock-up Agreements

When ServiceNow came public in July, its IPO prospectus contained the standard 180 day lockup provision which prevents insiders from selling for 6 months. This provision is added to IPOs in order to spur market confidence so that people will buy into the offering without fear of a wave of insider selling.Yet in this case, the company and its underwriters agreed to break the lockup. ServiceNow made use of a provision in the newly enacted JOBS Actwhich can be taken by “emerging growth companies” to get around the lockup and sell early. Clearly such a provision defeats the entire purpose of having a lockup in the first price.In addition, with a market cap of $4-5 billion it is hard to consider ServiceNow an “emerging growth company”. ServiceNow itself notes that the cutoff level to continue being an “emerging growth company” is just $700 million. From the most recent 10K notes:

if the market value of our common stock that is held by non-affiliates exceeds $700 million as of June 30 of any year starting with June 30, 2013, we could cease to be an “emerging growth company” as of the following December 31.

Shortly after successfully breaking the lockup agreement, ServiceNow completed an equity offering of 16.1 million shares at $28.00 per share.The investment banks involved were familiar, as expected: Morgan Stanley, Citi, Deutsche Bank, Credit Suisse, Barclays, UBS and Wells Fargo. Also as expected, these are the banks which continue to cover the stock with bullish research.The primary purpose of this transaction was not to provide new money for ServiceNow. As noted,

Of the 16,100,000 shares of ServiceNows common stock sold in the follow-on public offering, 1,897,500 shares were sold by ServiceNow and 14,202,500 shares were sold by selling stockholders.

So in this case, the urge for insiders to sell was so urgent that the then $4 billion company took an exemption for “emerging growth companies” so that insiders could sell 14.2 million shares at $28.00. The selling insider was the JMI Funds and El Caminio Advisors. ServiceNow board membersCharles Noell and Paul Barber serve as managing directors at these funds, so the insider selling is about as “inside” as one can get.As per the original Underwriting Agreement ServiceNow’s lockup should have been extended for 34 days past the original February date due to earnings / material news being announced in January. But as early as November, the company was eager to use the provision to have this waived so the insiders could begin selling as soon as possible. As should be expected, the have begun making good use of their freedom to sell.So why do analysts keep saying BUY ?If insiders keep selling as early as they can, then why do sell side analysts keep telling us to buy the stock ?Hopefully it did not escape the attention of readers that in the November equity offering 88% of the $450 million in proceeds raised went to the selling shareholders who wanted to violate the 180 day lockup. Only 12% of the proceeds went to ServiceNow.ServiceNow is currently a $5 billion company with a cash balance of $313 million, which is by no means an excessive cash balance. In addition, the company continues to operate at a loss and its current ramp up and hiring spree will no doubt prove to be expensive.Given that the company realized minimal proceeds from the November offering, it is certainly likely that the $5 billion company makes a very good candidate for an equity or convertible (equity-linked) financing.

In any event, anyone who has ever worked on Wall Street can be certain that the pitch books from Morgan Stanley, Barclays, Credit Suisse and UBS are all flying furiously across the desks of ServiceNow management, encouraging the company to “take advantage of current strong market conditions” by selling equity soon.

Given that all members of management have demonstrated their eagerness to sell large volumes of stock at current prices (and well below), it also stands to reason that they would be eager for ServiceNow, the company, to raise equity financing at current prices.

In the November equity offering (ie. the large insider sale) the offering price was just $28.00. On the first day of the lockup expiration, both Mr. Luddy and Mr. Slootman sold at below $28.00.

As a result, we now have a pretty good idea of where management feels the stock needs to be in order to hit the sell button.

But are the analysts wrong about the price targets ?

Yes, the analysts are wrong about the targets and this can be demonstrated by looking at their own reports which contain a number of false assumptions and numerical errors.

The specific flaws are consistent across many of the analyst reports. Analysts have justified their upgraded target prices for ServiceNow simply due to the recent rise in comps such as WorkDay (WDAY) and Saleforce.com (CRM).

They have also chosen to dismiss the impact of the expiring lockup even as insider sales accelerate.

In addition, despite the near unanimity of share price targets, there has been a fairly wide divergence in the share count used for calculating it. ServiceNow addressed this confusion on its last conference call, clarifying that it has 164 million diluted shares outstanding. Some analysts have been wrong by as much as 30% on this number.

The contents of the recent research reports by Credit Suisse, Morgan Stanley, UBS, Barclays and others have been highly consistent in their findings and share price targets. But the recent UBS report provides the clearest example due to the fact that the firm switched from a SELL to a BUY within just a few weeks, and right as the lockup shares became free.

On December 19th, UBS placed ServiceNow on its “Least Preferred” list giving it a $30.00 price target with a $24.00 downside target. The report contained the following justifications:

Thesis:

There is no disputing NOW’s strong growth rates, disruptive technology and customer base. However, we think the stock is overvalued as the 2nd most expensive name in our group at 12.5x FY13 EV/sales and growth is set to decelerate meaningfully in FY13… as a recent IPO, there are multiple share lockup expirations coming in Q1 with 92M shares becoming eligible for sale (vs. 700k ADTV)

Yet within 8 weeks, UBS had flipped from a SELL to a BUY recommendation, giving the stock a $36.00 target. The new justifications cited for the upgrade are as follows:

Our new Buy rating reflects 3 changes, 1) multiple compression played out, NOW trades inline to comps on 2014 ests despite 49% faster growth, 2) in recent weeks NOW finally priced its platform separately which we expect to be accretive to deal value, 3) 2/14 lockup expiration last of the major share unlocks.

Hopefully most readers will see the two largest problems immediately. The “multiple compression” which UBS refers to simply means that other stocks such as Workday , Splunk (SPLK), SolarWinds (SWI) and Salesforce.com have rallied even more than ServiceNow. The $36.00 target is therefore justified by the fact that other money-losing, high P/S multiple stocks are now just as overvalued. Obviously this type of valuation methodology does nothing to tell us whether or not ServiceNow is overvalued relative to its own fundamentals and prospects.And incidentally, these comparable stocks such as Workday are now seeing nearly identical concerns from critics, as shown in this recent article entitled:Workday: Overvaluation And Lock-Up Expiration Will Cause Shares To Crash.The analysts’ rationale for buying these stocks is no different that what we saw in the Great Internet Bubble which imploded in the year 2000. By upgrading a Pets.com just because a Stamps.com had traded higher, what analysts were really doing was simply pushing the whole space higher. When the stocks trade down substantially the analysts will then tell us (after the fact) that they are downgrading the stocks due to “multiple contraction“.The second major flaw (which is shared across most of these reports) is that analysts are upgrading the stock because the lockup has now expired.It is now the case that there are roughly 90 million shares which have become free for insiders to sell at any time or price they please. In the past 8 weeks we have seen insiders steadily unloaded over $80 million in stock regardless of the price. The time for investors to take relief regarding the lockup will be once the overhang is removed due to completed sales by insiders, not due to the fact that these insiders are able to begin selling.With ServiceNow, the selling is just beginning and it is beginning with a very strong start. If anything, now would be a time for analysts to maintain caution regarding the overhang.Why do insiders sell ?

By making use of a JOBS Act exemption intended for small cap companies to raise additional operating funds, ServiceNow insiders stuck to the letter of the law but certainly bent the intentions of the act by a wide degree.

By selling $13 million of stock on the first day of the February lockup expiration, they further communicated their eagerness to get out of the stock regardless of price. As we can see, the $13 million was just the beginning.

Many of these sellers undoubtedly learned the value of “sell early, sell big” as a result of the massive gains they realized shortly before their previous company imploded due to findings of fraud. Had they not made use of similar creative maneuvers to sell early, they would have been stuck sitting on worthless shares along with the rest of the investors in those stocks.

Now that they are substantial insiders at ServiceNow, they appear to be replicating this philosophy of “sell early, sell big”.

At Peregrine Systems, many of the early sales by these insiders were completed during a “no sale” blackout period imposed by the company which had already been communicated to the market. Their defense for doing so would likely be that they were not (in theory) “insiders” because they knew nothing about the company’s inner workings when they unloaded over half a billion dollars worth of stock.

ServiceNow Director John Moores had previously been Chairman of Peregrine Systems and his VC firm JMI Capital held a substantial stake. He had recruited Fred Luddy to assume the eventual role of Chief Technology Officer. ServiceNow Director Charles Noell served as a Peregrine Director and as the Audit Committee Chairman.

The SEC complaint describing the fraud at Peregrine systems can be found here. Like ServiceNow, Peregrine was based in San Diego. The San Diego Union Tribune provided significant detail on the $4 billion fraud implosion, including the following:

“The indictment charges these defendants with a massive conspiracy that had at its core one corrupt goal: to hit the numbers quarter after quarter, no matter what,” Attorney General John Ashcroft said in a statement.

Like ServiceNow, Peregrine had a habit of beating expectations, even as insiders continued selling into the successful results. The similarities between the two San Diego companies are noteworthy.

From its initial public stock offering in 1997 through mid-2001, Peregrine reported 17 consecutive quarters of growth that met or exceeded Wall Street analysts’ expectations. … Although Peregrine was unprofitable, its ever-increasing sales suggested it was dramatically expanding its share of the market for business software. One of the company’s biggest productshelps large organizations keep track of desktop computers and other assets. Another big seller helps coordinate computer help-desk services.

As the fraud findings shook out, John Moores and his JMI Capital certainly received some unwanted attention due to the size of his early cash-outs which occurred in the middle of the period where the fraud was at its peak:

Moores had sold most of his ownership stake in the company by 2001, including more than $600 million worth of Peregrine shares sold during the long-running fraud.

From July 1999 to February 2001, Moores sold more than 10.9 million shares of Peregrine for nearly $402 million, the suit alleges. Nearly 5 million shares were sold during company-imposed “blackout periods” that prohibited sales by key executives and board members.

Moores and other outside directors (including ServiceNow director Charles Noell) were found liable for $56 million in settlements, as noted:

of the directors’ total $55.75 million settlement contribution, $27.5 million is to be paid in the form of a note signed and payable by John J. Moores and Rebecca Ann Mores as individuals and as trustees of the John and Rebecca Ann Moores Family Trust. The stipulation also provides that the security for the note will be provided either by a letter of credit or by a security interest in JMI Holdings LLC’s economic interest in a San Diego hotel.

By the time the dust had settled, 18 members of Peregrine management had been charged with fraud and 14 were ultimately sentenced.Frederic Luddy eventually settled for $100,000. It was his second tough break with a promising software startup. When discussing his previous failed attempt with Enterprise Software Associates, he stated:

I have advice for any entrepreneur, which is if you’re starting a company and you have a partner, you should first find out if your partner is a convicted felon for fraud. I forgot to do that.

But things finally turned for Mr. Luddy and Forbes now estimates his net worth at $400 million.ServiceNow’s current CFO, Michael Scarpelli, was less fortunate. When his former software venture imploded due to fraud, he had not sold and the company ended up at just 8 cents on the pink sheets once the fraud was uncovered, down from over $14.00.However with ServiceNow Mr. Scarpelli has been much quicker to sell, already pulling in nearly $5 million in the past few weeks.Scarpelli had originally been a partner at PWC in the 1990′s at a time when PWC was auditing a software company called HPL Technologies. Scarpelli eventually moved from his role as auditor at PWC over to a management role with HPL Technologies, ultimately becoming CFO.During his tenure at HPL it was uncovered that as much as 80% of revenue had been improperly recognized and that the CEO had used a subsidiary to funnel cash into his personal account. PWC and UBS were then named in a$100 million lawsuit, with the lead plaintiff attorney stating that “It’s inexcusable that an audit could have been done and not detected these irregularities.” The biggest issue was that the audit failed to uncover of $10 million of missing cash, which should normally be very easy to detect.ConclusionNo one, myself included, is presently accusing ServiceNow of committing fraud.

The current observation is simply that the only thing more blistering than the pace of ServiceNow revenue growth has been the blistering pace of insider selling.

ServiceNow came public in July of 2012. In the 8 months since, insiders have already cashed out of over $400 million in stock. This is excluding the amounts sold in the IPO itself. And the pace of selling continues to be brisk nearly every week, regardless of the share price.

Wall Street analysts (from the very banks who run ServiceNow’s financings) are telling the rest of us to buy into the shares even at prices up to $43.00. Yet the insiders have demonstrated an eagerness to sell at prices of $28.00 and below. This has been the case even when these sales required a creative interpretation of the meaning of “emerging growth company”.

History has shown that insiders know their own companies far better than Wall Street analysts. History has also shown that Wall Street analysts can find many reasons to upgrade and recommend stocks, while sellers typically have only one reason to sell big and sell early.

Post script

The details of the multi-billion dollar accounting fraud at Peregrine Systems are truly fascinating for those who are interested in such things.

According to this Complaint:

To perpetuate the accounting fraud, members of Peregrine’s senior management

team would communicate near the ends of quarters to determine how much additional revenue the company needed to book that quarter in order to meet or exceed analysts’ expectations.

They would then devise fraudulent and misleading transactions, as described herein, and the resulting “revenue” would be recognized in that quarter in order to mislead the analysts and the investing public into believing that Peregrine’s financial condition was significantly better than it actually was and to maintain Peregrine’s inflated stock price.

The complaint contains multiple references to quotes by management speaking of starting a new company such as “End-of-the-Quarter.com” which would “sign sham deals for a fee to help companies meet their quarterly forecasts”.At its peak Peregrine reached $9 billion in market cap, making it somewhat smaller than the more notorious frauds such as Enron and Worldcom. But the details revealed in the filings are every bit as egregious and equally intriguing.Disclosure: I am short NOW. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

ZIOP: Retail Gets Slaughtered

sheep

 

Shares of Ziopharm Oncology (ZIOP) plunged by 64% to $1.82 on Tuesday when it released news that its only late stage drug candidate failed to meet its primary endpoint. For now, there isn’t much of a play except for those who may wish to bet on some further downside.

No one can truly predict in advance the outcome of Phase III trials, however with Ziopharm there were a steady stream of clues that investors should be skeptical about its prospects. At $2.00-$3.00 some investors could have been justified in investing in Ziopharm, but at nearly $6.00 the risk / return profile became downright silly.

Although I am currently working on my next report… I thought it would be useful to weigh in on how investors can try to avoid the next Ziopharm or at least minimize the damage from it.

Ziopharm is (was) a stock with a fanatically loyal retail following but very low institutional ownership. Typically around 50-60% of the stock has been held by retail. Much of the reason why retail investors continued to push up the share price to nearly $6.00 is that they felt they were making an identical bet with billionaire biotech investor Randall J Kirk.

But they failed to realize that even after making a number of open market purchases, Kirk had invested in Ziopharm at a far lower overall price due to his ability to get free shares when investing. Following the one-day plunge, retail investors are now sitting on catastrophic losses. By contrast, Kirk has lost just 5% vs. his overall in price of just $1.91.

The purpose of this article today is not to say “I told you so”. Instead the purpose is to highlight the areas where investors went wrong and to hopefully allow investors to avoid similarly large losses in the future.

The lessons to be learned from Ziopharm are as follows:

Lesson 1 – Be wary of low institutional ownership

During its life, Ziopharm was always a stock with low institutional ownership. A few years ago, famed billionaire and genius biotech investors Randal Kirkbegan investing in Ziopharm, which in turn attracted Fidelity to invest. Aside from these two players, Ziopharm remained a largely retail stock for a long time.

There is nothing wrong with investing in retail dominated stocks, but they should certainly require a discounted price. Institutional investors deploy armies of well trained analysts and vast amount of financial resources for one single purpose: they want to make money.

In most cases, if a certain stock presents a compelling value opportunity it will certainly attract institutional attention. The lesson to be learned is that retail stocks which trade at premium valuations are very dangerous. It is better to wait and buy in at a time when the share price is weak rather than chase the valuations higher. If no such opportunity presents itself then it is best to not play at all.

Lesson 2 – “Who wants to be a billionaire”

Investing has always been difficult and there are no easy formulas for making money. Individual stocks must stand upon there own merits.

Yet with Ziopharm we can see that droves of retail investors simply took the view that if they bought what Randal Kirk had bought then they could get rich too.

Anyone who has followed Kirk’s investing career knows that Kirk should really be considered a genius within the world of biotech. However in the case of Ziopharm, the prospects of the company simply did not match up to the share price.

This is not a case of 20/20 hindsight just because the drug failed. Prior to its failure, Ziopharm could have been considered (by some) to present a sensible risk / reward profile at $2.00-$3.00.

In trying to make themselves mini-billionaires, many investors seemed to ignore the fact that Kirk has invested on terms which were different than the rest of the market, obtaining an in-price of just $1.91.

This was true even though he continued to buy lesser amounts of shares even at prices above $5.00.

Kirk is currently using Ziopharm as a vehicle to advance his Intrexon drug technology. As a result, with Ziopharm now sitting at multi-year lows below at $1.82, he may even consider buying the entire company to further that goal. This will be of small comfort to anyone who was paying over $5.00 last week.

For a billionaire investor, it is largely irrelevant whether he purchases the remainder of the company at $1.00 or at $6.00. He will still own the entire company and will still have plenty of money to spare.

The key lesson to be learned is that if you’re not a billionaire then don’t try to invest like one.

Lesson 3 – Don’t shoot the messenger

first wrote on Ziopharm back in October of 2012 following several months of research. share price dropped by more than 30% to below $3.30. Yet Ziopharm issued an aggressive response and the share price rebounded to well above where it was prior to my article. Investors may now want to ask themselves “what sort of response would you expect from the company ?!”

Of course investors would not expect a company whose share price is falling to release a statement that says “the shorts are right”. Nor would we expect the company to say nothing. Instead, Ziopharm did what was expected and put forth a statement that assembled as many positive data points as possible without actually refuting a single point that I had made.

At that time, investors were in a uniquely advantageous position. They were now in possession of substantial amounts of negative information and yet were able to sell at a price which was actually higher than when the information was released.

The lesson to be learned is that investors should evaluate all new information based upon its own merits and not unfairly discount new information because it is negative or because it contradicts the investor’s original opinion. Investors can avoid substantial losses by giving a fair evaluation of opinions from people who hold drastically opposing views.

Lesson 4 – Retail oriented stocks are wildly market-inefficient

Back in November, Ziopharm announced that results of its upcoming Phase III trial would be delayed until March. This was the case even though as late as October Ziopharm had continued to tell investors to expect near term results. The delay caused Ziopharm to begin a moderate (rather than speedy) descent to below $4.00 within the coming 8-12 weeks.

Yet as the key March deadline approached (and as risk increased), the share price skyrocketed to nearly $6.00.

It is quite clear that many investors regarding the rising share price as amarket-efficient vote of confidence that results would be good. Instead, what really happened is that more and more retail investors simply hopped on to a fast moving train at ever increasing speeds. It was a classic self fueling and market-inefficient bubble.

Likewise, when the stock rebounded following my initial negative article, many retail investors simply decided that the conclusions could simply be disregarded because the “efficient” market had already cast its vote.

The lesson to be learned is that retail driven stocks are subject to periods of euphoria where investors are simply looking for any new reason to buy a stock while disregarding sell signs which become increasingly obvious.

Lesson 5 – The shorts might not be as stupid as you think

Hopefully it will not escape then attention of most readers that Ziopharm did in fact have a meaningful institutional presence. But rather than being long, these institution were overwhelmingly short Ziopharm and in sizeable amounts.

When my article was released in October, many retail investors began posting on bulletin boards that it was just a transparent ploy by which shorts were hoping to exit a skyrocketing stock in which they were trapped.

Yet when the subsequent short interest numbers were released, it could be seen that short interest actually increased slightly rather than decreasing.

The conclusion to be had was that rather than scampering to exit a stock in which they were trapped, the shorts had tremendous conviction. Rather than covering their short position with a gain of over 40%, they waited until the final results due to their certainty that fair value was in fact far lower.

The only thing more dangerous than investing in a retail dominated stock is investing in a retail dominated stock with a huge short interest ratio. Short investors tend to overwhelmingly be institutional rather than retail and have the resources to conduct research which is far more thorough than what they refer to as “dumb retail”.

On the short side, potential losses are unlimited. An investors who was short Ziopharm could easily have lost 100% or even 300% of his initial investment amount if the drug had succeeded. Even now that they have been proven right, short investors are still only making around 65% vs. the recent prices in the $5.00 range.

This is the exact opposite of long investors who stood to make several hundred percent gains with no cost of borrowing shares and with a fixed limit to their downside.

As a result, those investors who chose to get short Ziopharm needed to do a tremendous amount of work to get comfortable with their position. The fact that the short interest was very large meant that conviction was very large and was backed by sizeable institutions.

In fact, when put up against this, it seems that retail simply didn’t stand a chance.

The lesson to be learned here is that shorts are not dumb investors. In fact, by necessity they need to be significantly smarter than long investors with most of their position. This applies doubly so to volatile healthcare and biotech stocks. If the short interest is high in a stock with low institutional (LONG) investment – then stay away.

Lesson 6 – Don’t get Charlie Browned

Yet every time Charlie Brown made a full speed run towards the football, Lucy would pull the ball away and Charlie Brown would land on his head yelling “ugh!”. Not long thereafter, Lucy would again hold up a football and Charlie Brown would once again run full speed, learning nothing from his previous pain.

The failure of Palifosfamide was not the first disappointment from Ziopharm, instead it was just the most dramatic. As I noted in a previous article, Ziopharm had for years been delivering failures and breaking promises. But in each case Ziopharm would come up with a newer and better reason to hype the stock. In each case Ziopharm would hold up the football as say “trust me Charlie Brown, this time it’s different”. Retail continued to run at the ball full speed.

Now once again, Ziopharm is attempting to divert the attention of investors away from the failed Palifosfamide and on to its new and compelling DNA platform in connection with Randal Kirk’s Intrexon.

When a company delivers failures, its stock should trade at a discount until it delivers some form of concrete proof that it can really deliver more than just a new set of promises and hope.

Lesson 7 – The dangers of group-think

At some point in the life of a stock it becomes a great time to sell. This is the case even when one likes both the company and the product. This is just another way of saying “buy low, sell high” will always beat “buy low, sell never”.

Yet retail stocks are prone to both group-think and cheerleading. With Ziopharm it was consistently the case that a small number of vocal authorswould shout down any hint of criticism no matter how well founded. As the share price rose, these authors would simply increase their level of optimism to an ever higher share price target. According to these authors, the right time to sell Ziopharm was never.

The uber-bullish authors have every right to express their opinions and every right to invest in line with those opinions. However, it is up to the rest of us to determine if they have drank too much of their own Kool Aid and if they are indiscriminately shouting down useful information about when to exit the trade.

The lesson to be learned is that when a small number vocal authors continue to pump a stock at higher and higher prices while disregarding any suggestions to sell, then that is probably a good time to get out before the stock corrects.

Conclusion:

Again, the purpose of this article is not to say “I told you so” and it is not a case of 20/20 hindsight. Instead it is my hope that investors who are tempted to chase the next great retail lottery ticket may think twice about some very obvious risk factors.

Often times there is a very good reason why institutions have passed on owning a given stock and have left it overwhelmingly in the hands of retail investors. In many cases some institutions may have been early investors but then exited when retail investors pushed the price up to irrational levels.

When the only institutions who have interest in a stock are overwhelmingly interested on the short side. Retail investors should start to question whether they are really investing on a level playing field. They need to ask if they have the information and the resources to fully understand a complex situation and to accurately monitor any new developments. In most cases the answer will be no.

In the case of Ziopharm, the company had delivered a stream of disappointments and broken promises yet it still retained a fanatical following among retail authors and investors who kept assuring one another that the right time to sell was never.

If investing was as easy as simply riding the coat tails of famous billionaires, then the rest of us could all become billionaires too. But as we can see from Ziopharm, billionaires seldom get that way my making open market purchases at all-time-high prices. When Randal Kirk continued to buy Ziopharm at prices above $5.00, many retail investors assumed that tremendous further upside was virtually guaranteed. Yet with a cost basis of just $1.91, it now seems that Kirk is the only one who is currently still showing a profit following the 64% drop in Ziopharm. The lesson here is: that’s why he’s a billionaire and the rest of us are not.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

TRLA: Stealth Lockups Allow Early Selling

stealth

 

A bubble for tech stocks is clearly back. The NASDAQ has more than regained everything that was given up in the Great Recession and at 3,213 it has returned to levels not seen since the year 2000.

Companies that provide technology solutions within the real estate industry are currently getting a very positive double whammy in terms of share price. They are benefiting from a strong perception that the real estate market is recovering and they also get a clear bump up just for being technology stocks during a technology bubble.

There is a noticeable amount of competition between publicly listed real estate technology stocks, including Zillow (Z), Trulia (TRLA) and sites such as MoveInc. (MOVE) and Yahoo (YHOO). In addition, industry leader Red Fin has announced its own intention to go public. As stated, “Last month, Redfinannounced that its listing business grew 120 percent in 2012 and the company plans to more than double its staff of listing agents this year to serve rising demand from its expanding customer base.”

With many technology stocks, we have recently seen notable insider selling in the IPO, along with increased insider selling as soon as the lockup expires. In fact, it is now the case that management from certain companies have begun pushing for “lockup lite,” such that they can begin selling after just 90 days instead of 180 days, subject to a share price trigger.

When Zillow came public at $20.00 per share, the shares quickly jumped to $44.00 before following a fairly steady downward path. It is almost 2 years later and Zillow is just now beginning to recover the value that it had achieved on its first day of enthusiastic trading. Zillow raised over $70 million in its IPO. In the 2 years since, insiders have now sold $128 million in stock. On the day of the lockup expiration, the shares tumbled 13%.

The fact that management teams feel the urgency to cut short the lockup period and begin selling early certainly telegraphs the insiders’ views about how sustainable the sharp spike in these shares will turn out to be. Why else would there be such urgency to shorten the lockup period by a mere 90 days?

The use of these early lockup triggers is somewhat problematic. In some cases, it encourages the company to set its IPO price too low, such that even a moderate pop is enough to allow insiders to get out of their stock. In addition, the binomial nature of the trigger and the potential timing creates a very strong incentive for management teams to “juice” their results with channel stuffing, excess promotion, early revenue recognition or accounting gimmicks.

With Trulia, we can see that the biggest surge in both users and revenues came just around the time of the IPO, although nothing appears to have been done improperly. Trulia certainly noticed the advantages of being able to sell stock early during a strong tech bull market, as was done by Zillow. Trulia basically copied the “lockup lite” provision from Zillow.

The official stated lockup date is March 19th, so it is now the case that most investors seem to think that Trulia will be safe from insider selling for another 3 weeks. However, because it copied the Zillow language on the lockup, the shares may become sell-able roughly 2 weeks sooner than investors had planned.

For the insiders, selling early makes perfect sense. Given that lockup dates are often associated with sharp drops in share price, the selling insiders of Trulia would be foolish to not sell at the earliest possible date, before the greater downward pressure hits the stock on March 19th. In short, “lockup lite” allows insiders to beat the officially stated rush to sell.

This is all the more so given that Trulia is now sitting at lifetime highs of around $33 and recently hit a $1 billion market cap. Trulia has never had a profitable quarter, and its record 2012 revenues amounted to just $68 million. A wave of sell-side analyst upgrades resulted in an average target price for Trulia of $32.00, but the stock just has continued to soar past all targets.
(Click to enlarge)


(Click to enlarge)

As shown above, the current share price is now well above the required trigger for selling before the lockup period ends. Prior to February 13th, sell-side analysts had targets on Trulia of $22-$28. All of the major analysts raised their target on Trulia into the range of $28-34. Yet Trulia has now jumped past all of those price targets and sits at around $33.00 after reaching a high of $38.22.

As with tech bubbles in the past, when Wall Street needs to find a way to get bullish about money losing companies, Wall Street just changes the metrics and uses non-GAAP items such as “Adjusted EBITDA” and “Adjusted Net Loss.” The measures basically allow a company to report all of the things that are beneficial in the short term, while ignoring items like interest, depreciation and the cost of stock options which still need to be factored in to the business. In effect, companies that report these numbers are saying, “if you focus on all of the positives and ignore all of the negatives, then our company is doing quite well. Trulia’s prospectus and earnings releases contain numerous warnings and caveats associated with these metrics while GAAP does not even recognize them.

Management and insiders already sold $15 million of shares in the IPO. We can also see from the prospectus that insiders may have the option to sell prior to the March 19th lockup expiration, as a result of the share price exceeding $23.80 for 20/30 days.

The total number of shares that become sellable at the lockup date is over 6 million, which constitutes over 22% of the total share count. There are ample reasons to expect substantial selling even before the final lockup expiration.

By way of reference, on Tuesday, Trulia fell by more than 11% on volume of just 300,000 shares. The catalyst was a downgrade from Buy to Hold by Deutsche Bank.

So even if the 6 million insider shares were sold over a period of numerous days, one would expect the share price correction to be significant.

Valuation

Although Trulia has made substantial progress in both financial and non-financial metrics, it is still the case that Trulia has never turned a profit.

The latest surge in the stock, which added over $9.00 to the share price, was the result of Trulia simply getting to a level where it was almost breaking even. Judging by the current $892 million valuation, many investors are no doubt trying to predict a trajectory for Trulia’s earnings. They are expecting a substantial jump into profitability within 1-2 quarters. Until that happens, we can see that Trulia is a phenomenally expensive stock vs. its peers.

If Trulia can continue bringing in record growth even while further increasing prices, then the best result in 2013 is likely to be somewhere between breakeven and $1-2 million per quarter in earnings. So in any event, even if Trulia achieves massive success in 2013, the valuation vs. current market cap will end up being a P/E in the range of 100-200x which is likely not a sustainable valuation over the course of 2013.

And in any event, a P/E of 100-200x certainly would provide adequate incentive and justification for insiders to sell as early as they can around the lockup.

2012 Revs 2012 Income Market cap Users / Month
Trulia $68 M ($11 M) $892M 23 m
Zillow $117 M $6 M $1,500 M 46 m
Move.com $190 M $6 M $388 M 15m

Business prospects

There are several reasons why investors should not be banking of a seismic improvement in Trulia’s financials. In other words, Trulia may not be able to lock in the record revenues that would be necessary to take the company from being a money loser into a profitable company in 2013.

First, the current financial results have been achieved due to a large surge in subscribers even while Trulia raised its pricing to subscribers. This had mostly occurred as Trulia was coming public in its IPO and as the trigger-based lockup expiration was being calculated.

Further gains of any similar magnitude would require yet another dramatic increase in the number of subscribers even as subscription rates would need to be further increased by a substantial amount.

Second, the outcome of the lawsuit against Trulia by Zillow is still uncertain.

A few years ago, Zillow created what it calls “Zestimates” as a way to obtain a vague estimate of the value of a home based on data from public filings. When Trulia launched a very similar service, Zillow sued. The outcome of the lawsuit is uncertain; however, even a quick glance at Trulia’s website reveals numerous similarities to Zillow’s patented Zestimates. Likely remedies could include financial penalties along with an inability to continue providing the service for Trulia.

Third, order to justify the current $892 million valuation, the magnitude of the needed financial improvement is tremendous.

Trulia’s past financial performance is as follows:

2009 2010 2011 2012
Revenue $10.3 m $19.8 m $38.5 m $68.0m
Net income ($7.0 m) ($3.8 m) ($6.1 m) ($10.9 m)
EPS ($0.40) ($0.21) ($0.92) ($0.87)

Assuming that costs will increase only half as fast as revenues, Trulia would have to achieve the following growth rates in order to provide the following valuations.

Revenue growth Revenue ($m) Net income ($m) P/E P/Sales
25% $85.1 -$3.4 (283.3) $11.48
50% $102.1 $2.6 372.5 $9.57
100% $136.2 $14.8 66.2 $7.18
200% $204.2 $39.1 25.0 $4.78

As we can see, even if Trulia can double its revenue over the next year, it would still be trading on a P/E of 66x and a Price / Sales of 7x. Yet we can already see the law of diminishing returns kicking in as Trulia grows.

In contrast to the scorching growth when Trulia was a small startup, QoQ growth looks set to dip into the single digits going forward. If this ends up being the case, then even if Trulia can start earning a profit, its P/E ratio will be well over 100x.

Perhaps of greatest importance is that Trulia recently gave guidance that sequential revenues are set to increase by just 0-3% in Q1 2013. Quarterly revenue growth is shown as follows:


(Click to enlarge)

Instead of seeing even double-digit revenue growth, a much more likely scenario is that Trulia will show a more realistic level of growth, and the valuation will contract to more sensible levels. This growth pattern should be quite obvious to the insiders in Trulia who know the industry well. And as a result, there exists a very significant overhang risk as the 6 million shares under the lockup are now becoming free to trade.

It should become clear that if Trulia shows some meaningful growth and can achieve profitability, then a justifiable valuation for the company likely falls between $18-$22.

However, developments in the industry may keep Trulia from achieving the growth that it is hoping for and may impact its potential to become profitable in 2013-2014. Under such scenario, a price somewhere below $18.00 could become very justifiable for the market.

Industry developments

According to the WAV group, sites such as Zillow and Trulia have far less content than the MLS does. In addition, the content they have is substantially less accurate. Zillow and Trulia fail to list a significant portion of the houses that are available on the MLS.

For the houses that they do list, the information is often inaccurate or outdated. For example, when a house has been sold or the price has been reduced, the MLS will reflect it almost immediately. Third party sites such as Zillow and Trulia often do not make such updates for as long as 1-2 weeks.

A few months ago, Ben Caballero (founder and chairman of the National Association of Real Estate Professionals - NAREP) formed a non-profit group with the express purpose of combating the inaccurate listings posted on sites such as Zillow and Trulia.

Trulia conducted its own study of inaccurate listings on its own site and concluded that it was less than 10%. However, a study by the WAV Group had revealed that a whopping 36% of the active listings on Trulia and Zillow were in fact no longer active at all, as reflected in the MLS databases. Mr. Caballero states:

I have no doubt their slowness to purge expired listings is a deliberate strategy. If you believe they have a different reason for doing so, then I have some valuable swampland in central Florida I’d like to sell you.

To the extent that Zillow and Trulia end up being forced to remove as many as one third of their listings, the impact will be felt both in terms of monthly visitors as well as in advertising revenue.

In addition, it is now becoming the case that companies which provide the listings to Trulia and Zillow are beginning to cut them off or demand far greater restrictions on their use. For example, as of January 1st, Point2 Technologies (a listings syndicator) is giving control over the listing back to the brokers and placing substantial restrictions on their use by publishers such as Trulia and Zillow. As stated,

A new listings distribution policy from the industry’s second-largest real estate listings syndication platform strictly limits what publishers can do with data they get, and challenges the business models of some.

On the rental side, Zillow and Trulia have increasingly been experiencingrental fraud postings. The issue is big enough that both have had to address it on their websites.

Typically the poster will take an identical posting from a similar site, then make a few minor edits, while cutting the asking price by 30-40%. Such a price typically appears to be an exceptional bargain, and results in a large volume of calls from prospective renters. The scammers then try to get the interested party to send a small deposit check, or they try to get them to fill out a credit check application in an attempt to commit identity theft.

The obvious solution to this problem is to perform greater verification. Some verification is currently performed, but obviously not enough to prevent fraudsters from abusing the system. The consequence of a greater supervisory effort would of course be the fact that many of the listings would be removed.

Conclusion

The market is now going through a very visible bubble in technology stocks. The NASDAQ is now at levels not seen since the Big Bubble thirteen years ago. Tech stocks with an additional real estate focus are benefiting even more due to improved prospects for the real estate market going forward.

However, the valuations which have been awarded to Zillow and Trulia are now so expensive that even phenomenal growth over the next 2 years would fail to put them at any type of sensible market valuation.

In bull markets, investors and analysts often become quite complacent in terms of what they will pay and what they will accept. Investors are currently looking for excuses to buy, not to sell, as they chase the returns upward. Sell-side analysts are looking for excuses to raise price targets.

The historical precedent of a 180-day lockup is now being waived on various occasions because the market is so strong that companies and their bankers can simply get away with pushing the envelope a bit further than in the past. However, many investors seem to be unaware of the stealth lockup releases based on share price triggers. The result is that when insiders start unloading stock, share prices will suffer.

Trulia has 6 million shares which will be fully sellable in less than 3 weeks. By incorporating a triggered lockup release, insiders have already telegraphed their eagerness to sell into a strong market and their realization that time matters greatly in a bubble market.

Even in the best case scenarios, a very high rate of growth will simply not justify the valuation that is already in effect. Meanwhile, various headwinds, such as the initiative by the NAREP chairman and Point2 Technologies to get inaccurate and outdated listings pulled from Zillow and Trulia, could potentially have a large impact on the sites’ ability to attract viewers and achieve profits.

Even at prices which are 25-35% below current levels, both Trulia and Zillow would still be required to post very strong growth in order to justify their valuations.

Yet Trulia has given guidance of just 0-3% revenue growth in Q1.

With Trulia, the near-term catalyst for a sharp drop in the share price will be the onset of insider selling as it pertains to the 6 million locked up shares. That lockup expires on March 19th; however, additional heavy selling could occur early as long as the share price remains above $23.80.

Biotech Bubble: Alnylam Triples Despite Setbacks

bubble pic

Disclosure: I am short ALNY.

The past 12-14 months have seen a very strong rally in the overall markets, sending the Nasdaq index to levels not seen in 13 years. Biotech stocks have largely been leading the pack and have provided spectacular returns to those who have been chasing the ultra-high beta returns.

Since the beginning of 2012, the Nasdaq is up by an impressive 21%. Meanwhile, the Nasdaq Biotech Index (NBI) is up by a stunning 44% in the same period of time.

As in most stock market bubbles, we can see that the best returns typically come from the companies, which have the weakest fundamentals. The reason for this is simple. Companies with strong fundamentals are typically very easy to value such that quantifying their potential upside is quite straightforward.

But for money-losing companies with little or no revenues, the bet is typically being made on a series of transformational events in the future which it is hoped will provide outsized rewards if they are actualized. Certainly no one is likely to predict strong and steady companies such as Cubist Pharmaceuticals (CBST) or The Medicines Company (MDCO) to become ten baggers, or even a three baggers. But for many of the earlier stage, unproven biotech stocks, similar multi-bagger predictions are very common at present.

One sure sign of a bubble in biotech stocks is the fact that many stocks tend to show sustained rises even when there is no news. During such times, news that is even slightly positive will have a very dramatic and positive effect on the share price.

Some examples of recent biotech high fliers are as follows:

Company Ticker % cng Market cap 2012 Revenue
Pharmacyclics (PCYC) 510% $6.3 billion $200 million
Arena Pharma (ARNA) 417% $1.8 billion $13 million
Infinity Pharma (INFI) 364% $1.6 billion $93 million
Alnylam Pharma (ALNY) 190% $1.5 billion $66 million
Sunesis Pharma (SNSS) 335% $271 million $5 million
Galena Biopharma (GALE) 310% $130 million Zero

* Stock price change since Jan 1, 2012

However the surest sign of a bubble in biotech stocks is when stocks keep rising even when there is a steady stream of bad news, which intuitively should have caused the stocks to fall rather than rise.

As the bubble mentality sets in, both investors and sell side analysts consistently fail to properly incorporate new and negative information. Investors continue to buy the shares, pushing up the price. As they did in the Nasdaq bubble of 2000, sell side analysts simply re-adjust their target prices to higher and higher levels to keep up with the ever rising share price.

The best example of a stock, which continually rises despite a stream of ongoing negative news, is Alnylam Pharmaceuticals.

In addition, Alnylam shows that in a stock market bubble, it is the fundamentally weakest stocks that show the greater rises. A comparison between Alnylam and Isis Pharmaceuticals (ISIS) illustrates this point clearly. Both of these companies compete directly within the RNAi space, yet Isis has a far broader product portfolio which is in later stages of development.

ISIS ALNY
Phase III products or above 4 Zero
Phase II products 14 1 ongoing
2012 Revenue $99 million $67 million
Market cap $1.5 billion $1.5 billion
Price change 102% 190%

* Stock price change since Jan 1, 2012

As can be seen, Alnylam has significantly outperformed Isis even though Alnylam has no Phase III products and only one Phase II product still active. In comparison to Isis, Alnylam has virtually no pipeline. Yet the two companies now have identical market caps and Alnylam’s price performance has been near double that of Isis since January 2012.

As shown below, shares of Alnylam have nearly tripled since the beginning of 2012, with much of the rise coming in just the past few months. In 2012 the shares traded as low as $8.33, while in 2013 the shares have risen nearly 30% from a low of $18.71.

(click to enlarge)

During this time there has been a stream of negative news which has bounced off the company with virtually no effect. As the share price has continued to rise, sell-side analysts have continued to re-price the stock at higher and higher levels, giving little or no weight to new negative developments. While a small minority of analysts have in fact raised the alarm about the disconnect between the share price and the company’s underlying condition, these warnings have gone largely unheeded or unnoticed. These analyst have suggested target prices for the stock at below $15.00.

A significant uptick in insider and company selling indicates that those who are in a position to know the most are well aware that the valuation has run well ahead of the company’s clinical progress or commercial prospects. For example:

  • Up until February 2012, insiders were consistent purchasers of the stock up until prices of $10.75. Since that time, insiders have been net sellers of sharesvalued at nearly $2 million in 6 months. The selling began as soon as the price started to exceed $17.00. Since February 2012, there has been only one insider purchase consisting of just 4,967 shares
  • Alnylam’s largest shareholder, Novartis (NVS), began liquidating its holding, selling $30 million of stock. As part of the transaction, Novartis knew it would lose its subscription rights to purchase more shares directly from Alnylam. Alnylam had previously obtained this subscription right to offset dilution from options issuance. Forfeiting this right as part of the sale shows that Novartis is comfortable with permanently reducing or eliminating its stake and is no longer concerned about its holding being diluted. Novartis also registered its remaining holdings for sale, signaling its intent to sell its remaining 4 million shares.
  • In January, when the stock hit $20.00, Alnylam itself also telegraphed that it recognized the shares were a “sell” rather than a “buy.” Alnylam issued $173 million worth of new shares in an opportunistic equity offering at $20.13 per share to raise $173 million. The offering represented a very large 17% of the company at the time, despite the fact that there was no new use of proceeds disclosed. The issuance of over $100 million in stock without a use of proceeds signals that the valuation at $20.13 was high enough to merit an outsized financing purely based on the elevated share price.

With the equity offering behind us, the next major catalyst which will signal a downward move in the stock will be continued insider sales along with larger sales which should be anticipated from Novartis.

The reason why insiders, large investors and management are eager to cash in on the current spike in Alnylam’s share price should be apparent. Even as the share price has tripled, Alnylam’s commercial and clinical prospects have without question encountered significant headwinds.

  1. In May 2012, Alnylam’s lead product ALN-RSV01 failed its Phase II trial. This product was the company’s most advanced product, and one of only two products by Alnylam to make it past Phase I.
  2. Shortly thereafter, Alnylam lost a lawsuit with Tekmira (TKMR) which had cited “relentless and egregious misappropriation of its trade secrets”. The two companies had worked together since 2004. Alnylam was forced to pay an immediate $65 million plus an additional $10 million in potential milestones to Tekmira.
  3. The spinoff IPO of Alnylam’s Regulus (RGLS) unit, a joint venture with IsisPharma, ended up pricing at $4.00, 60% below the indicated range of $10.00-$12.00. Alnylam owns 17% of Regulus.
  4. As shown below, Alnylam’s “5×15 Product Strategy” predicting five products in late-stage development by 2015 is now looking more like a “1×16 Strategy” or perhaps a “2×17 Strategy” at best. Yet Alnylam has redefined the meaning of “5×15″ and now continues to use this marketing phrase in a more “conceptual” way.

Under normal market conditions, each of the items above would certainly be regarded as a very large and material setback to a major part of Alnylam’s business. Yet in the current biotech bubble environment, none of the items above resulted in any meaningful drop in the share price or any revision by sell side analysts.

At the same time, a number of much smaller (but positive) announcements saw the share price jump immediately.

When Alnylam subsequently released new data on its hemophilia drug, the share price immediately soared by nearly 50%, reaching a then-high for the year of over $19.00.

This was the case even though the data were simply the results of pre-clinical trials only.

At roughly the same time, Alnylam announced positive results for its new lead product ALN-TTR02. Although the new lead product had simply proceeded though Phase I only, the stock was buoyed, offsetting the larger failure of its former lead product in the more significant Phase II trial.

Analysts have largely ignored the relative magnitude of the negative vs. positive developments. In each case, as the share price has risen, analysts have been quick to raise their price targets to an even higher price.

The justifications for the most recent round of price target hikes were based on a number of very small positives such as:

  1. partnering with The Medicines Company to collaborate on a cholesterol drug. However, this drug is currently only in pre-clinical / Phase I trials.
  2. In February, Alnylam announced that:
    - its Q4 net loss had quadrupled vs. the previous year
    - revenues had fallen by 60% from the prior year
    - for the full year, Alnylam lost over $106 million.
    Despite the negative trends revealed in this data (and with no new clinical developments) analysts once again upgraded the stock causing the share price to jump by 7%.
  3. In January, JP Morgan highlighted multiple new products to be pursued as part of the “5×15″ strategy. Yet the JP Morgan report noted that these products would be either in pre-clinical or Phase I stages in 2014, effectively precluding them from meeting the Alnylam’s original criteria for “5×15″.

Alnylam’s “5×15 Strategy” has become a “1×16 Strategy”

Alnylam’s product strategy is a very complex and intricate one such that the science is well beyond the comprehension of many potential investors. As a result, in order to make things easier for investors to understand, Alnylam came up with a way to tell investors that “we will be making substantial progress on our pipeline, and we will be making it very soon”.

In January of 2011, Alnylam launched its “5×15 Product Strategy“, which stated that:

The company expects to progress five RNAi therapeutic programs into advanced clinical development by 2015, with the potential for early commercialization opportunities.

For any biotech company with a very early stage pipeline, this was a very bold public statement. Getting five therapeutic programs into advanced clinical development within four years should be considered a major challenge.

Two years have now passed. Alnylam’s lead product (ALN-RSV01) failed inPhase II clinical trials and just one other product has entered Phase II to take its place. The new product ALN-TTR02 is scheduled to complete Phase II clinical trials in mid-2013. If it meets its endpoints, it will then proceed to Phase III, with potential commercialization in 2016 subject to ultimate FDA approval.

The “5×15″ slogan has been a very useful way to encapsulate for investors Alnylam’s very complicated product strategy. However with just two years left and only one product having successfully progressed beyond Phase I, it now appears that there is zero possibility of achieving anything close to the initially stated goals.

As a result, Alnylam’s “5×15 Strategy” is beginning to look more like a “1×16 Strategy”. Although with the subcutaneous variation of the product, this could also potentially become a “2×17 Strategy”.

In any event, at the time of the “5×15″ launch, Alnylam had a market cap of $500 million. Following the recent equity offering, the company now boasts a $1.5 billion market cap even though its realized results in product development will be substantially less, and occur substantially later, than was initially projected.

Back in May, when ALN-RSV01 failed, Alnylam was a $500 million company with $180 million in cash. Alnylam’s entire pipeline was therefore worth just $320 million. Had the Phase II trial been successful, there would likely have been substantial upside in the stock. However, when the trial failed, downside was cushioned by the fact that Alnylam had several other shots in goal, including ALN-TTR02.

Now, in 2013, the risk / reward proposition has been flipped upside down. The valuation has currently spiked to $1.5 billion. Even if ALN-TTR02 passes Phase II this year, there will likely be limited further upside given that success has already been priced in.

But if the product fails Phase II, then the downside will need to be very substantial. Unlike in 2012, Alnylam is now lacking in a near term back-up plan at the same time that the valuation has spiked. So while the upside at Phase II is now limited, the downside is now quite substantial.

Absolute valuation vs. relative valuation

So far, the data points presented demonstrate quite clearly that there has been a significant disconnect in the relative valuation of Alnylam. In each case there has been some new development which was substantially detrimental to Alnylam, with the result that the company as a whole should have been worth something less relative to what it was worth prior to the realization of the news.

Given that the share price continued to triple through such news, it should come as no surprise that there is an even larger disconnect in the absolute valuation of Alnylam. In other words, what is Alnylam really worth in absolute terms vs. the $1.5 billion market cap of the company.

From the following graphic, it can be seen that the bulk of the value of Alnylam is attributable to one product only, ALN-TTR02. Alnylam’s RSV product failed at the end of Phase II and its status is now unclear. The remainder of its products are now either in Phase I, or are not even in clinical trials at all yet.

(click to enlarge)

With the vast majority of the current value of Alnylam being attributable to ALN-TTR02, and with a current market cap of $1.5 billion, the breakdown of valuation components can be roughly described as follows:

(click to enlarge)

The “other” category consists of products which are still in Phase I or which have not even begun clinical trials. Valuing these products at $380 million (25% of the value of the company) is likely more than generous in comparison to publicly listed biotech companies with similar early stage portfolios. It is also in line with (and slightly greater than) what the market valued these products at in May 2012, when its lead product failed in Phase II. Alnylam has disclosed that it expects to end 2013 with around $320 million in cash.

The point of this graphic is that the recent surge in market cap of Alnylam now needs to be overwhelmingly justified by the results of just one product, ALN-TTR02. If that product succeeds in Phase II trials, then there may not be much additional upside. However, if the product fails, then the share price could fall by as much as 54% to around $12.00.

The failure of ALN-RSV01 was entirely unexpected. However, the very low valuation of the company at the time cushioned the stock from any impact. Now however, there is virtually no upside to be had from success and tremendous downside to be had if Alnylam encounters a second unexpected failure inPhase II.

The value of a successful Phase II for ALN-TTR02

ALN-TTR02 and ALN-TTRsc are intended to be orphan drugs to treat ultra-rare indications (FAP and FAC) affecting just 50,000 individuals worldwide.

There are already multiple competing products being brought by competitors which are further along than Alnylam. Pfizer (PFE) has Vyndaqel which is inPhase III in the US and is already approved in Europe. Isis, along with partner Glaxo (GSK), has ISIS-TRRx which is proceeding with a Phase II/III study.

Despite the fact that it is farthest behind with a drug that may end up losing in a winner-take-all race for orphan status, the market is awarding a $800 million valuation to this single drug, which has yet to even complete Phase II.

By comparison, the entire value of Isis is only $1.5 billion, which includes its own similar (and more advanced drug) along with a pipeline of more than a dozen other advanced products.

Ultimate commercialization still needs to await a successful Phase II trial, then a successful Phase III trial, along with final FDA approval. If all of these things happen as desired, then Alnylam may begin to receive revenues from it in 2016, three years from now.

As a result, any valuation above $300 million would be considered overly optimistic based on its current status.

To further demonstrate this benchmark valuation, it should be noted that when Pfizer acquired competing drug Vyndaqel, it did so by acquiring all of FoldRX(the developer of Vyndaqel) and its entire drug portfolio for a total price of $400 million.

At the time, FoldRX’s most advanced drug was tafamidis meglumine, which was in late stages for approval for treating transthyretin amyloid polyneuropathy. Other products in earlier stages included drugs for Parkinson’s disease, Huntington’s disease and cystic fibrosis.

At the time, Vyndaqel was in Phase II, just like ALN-TTR02 is now.

Again, the purchase price for the entire portfolio was $400 million, which would result in a value for Vyndaqel of around $100-200 million.

As a result, with Alnylam the valuation risk here is considerable.

Even if ALN-TTR02 achieves successful Phase II results, the valuation of Alnylam could easily be expected to contract by as much as $500 million simply because the current valuation for Alnylam has far overshot its market potential of its only near-term drug as a result of the current biotech bubble.

Conclusion

Taking a larger picture view, it is important to keep in mind that Alnylam is engaged solely in the production of RNAi therapeutics. However, the FDA has never even approved a single RNAi therapeutic (drug), ever.

In addition, Alnylam has yet to advance a single product into a Phase III trial.

At present, the $1.5 billion valuation of Alnylam is overwhelmingly dependent upon the near-term clinical prospects of a single drug, ALN-TTR02. Yet the valuation has already spiked so dramatically amid the Biotech Bubble, that very little upside remains even if the trial is successful. In fact, given the current valuation of the company, a successful trial amid a flattening biotech market could still see the value of Alnylam’s stock correct by around 20-30% by itself.

If the trial fails, then the valuation of Alnylam will be determined according to the company’s other drug prospects which are all currently in Phase I or in pre-clinical development. As a cushion, Alnylam has disclosed that it expects to end 2013 with $320 million in cash, which equates to $5.24 per share in cash.

The result of a failure in Phase II would be a valuation for Alnylam of at most $700 million, implying the potential for a drop of more than 50%.

Over the past 14 months, investing in Alnylam (and many other biotech stocks) has been a very enjoyable one-way street. Bad news has simply not mattered.

Yet at some point in time, the valuation simply must reconnect with the fundamental prospects of the company.

Insider activity strongly points to the fact that insiders are well aware of the overshoot in the stock. The higher it goes, the more they sell.

Insiders were net buyers at prices of around $10.00 and below, yet they quickly became net sellers at prices of $17.00 and above.

Novartis was quick to forego its subscription rights in order to sell off $30 million in stock at elevated prices. Novartis had previously been the single largest shareholder in Alnylam. The registration of its remaining shares indicates that Novartis will continue to monetize its stake rather than hold until 2016 to see if revenues materialize.

Last, a few weeks ago Alnylam itself was quick to issue shares representing 17% of the company, despite no new use of proceeds. This speaks loudly to the fact that a price of $20.13 is one that should be locked in quickly and in large size, as confirmed by Alnylam management.

The current price of $23.44 is 20-30% above where insiders, Novartis and Alnylam itself has been selling shares in large volume. And in the near term there remain no natural catalysts for further upside movement in the stock, withPhase II results not being expected until mid-late 2013.

The one-way street appears to have hit a dead end for now, and it is likely time to head back in the opposite direction.

Additional disclosure: The author was previously an investment banker for a major global investment bank and was engaged in investment banking transactions with a wide range of health care companies including pharmaceutical, genomics and biotech companies. The author has not been engaged in any investment banking transactions with US listed companies during the past 5 years. The author is not a registered financial advisor and does not purport to provide investment advice regarding decisions to buy, sell or hold any security. The author currently holds a short position in the stock of ALNY and has provided fundamental and technical research to investors who hold a short position in the stock. The author may choose to transact in securities of one or more companies mentioned within this article within the next 72 hours. Before making any decision to buy, sell or hold any security mentioned in this article, investors should consult with their financial advisor. The author has relied upon publicly available information gathered from sources which are believed to be reliable and has included links to various sources of information within this article. However, while the author believes these sources to be reliable, the author provides no guarantee either expressly or implied.

PCRX: Pacira Stretched Thin

Stretched-Thin-Mickey

 

Pacira Pharmaceuticals (PCRX) is an emerging specialty pharma company which in 2012 launched an opiate alternative (“Exparel”) for post surgical pain management. The product is currently approved for use in certain post surgical pain applications including removal of hemorrhoids and bunions.

Since the product launch in April 2012, the shares have tripled, enjoying a boost from strong sequential revenue growth along with a surging bull market for healthcare names across the board.

Pacira Share Price vs. NASDAQ Index

Had the price remained in the $12-13 range, the company could easily be viewed as a potential acquisition target for a Big Pharma player looking to expand its pain management portfolio with specialty drugs.

However with the price now hovering close to $30.00, Pacira’s market cap is now roughly $1 billion, making the economics of a buyout prohibitive for any Big Pharma buyer. As a result, at current prices, Pacira will be forced to justify its valuation by expanding sales and by ultimately generating its first-ever quarterly profit. It is currently hoped that this will occur sometime in 2015.

The growth in Pacira’s valuation has occurred very quickly, and in fact has significantly outpaced the growth of Pacira as an operating company as well as the still nascent growth of its only real commercial product. As a result, it may well be the case that a pull back around $18.00 should be expected in the near term – a decline of roughly 30%.

This view is supported by the fact that in January, Pacira saw the onset ofinsider selling by Sanderling Ventures of around $10 million at a price of $18.93.

Likewise, as soon as the shares broke through $18.50, Pacira was quick to issue a $120 million convertible bond which can be converted into Pacira shares.

As the share price continued to rise, the selling continued as would be expected. On March 7th, Sanderling once again reported a cashless exercise of warrants netting over 50,000 shares.

On March 11th, three after-hours block trades totaling over 1.3 million shares (nearly $40 million) went through at a 5% discount to the closing price.

Sanderling’s recent Form 4 filings shows that it was responsible for an additional 374,000 at $27.73 (also about a 5.5% discount to the day’s close). The seller of the remaining 1 million shares should be disclosed shortly.

In any event, the rush seems to be building to begin exiting Pacira at its heightened valuation. Sanderling has now exited the majority of its position. Most recently, rather than sell its shares over several days, Sanderling chose to lock in an immediate 5.5% discount.

There are a number of key issues for investors to consider when evaluating Pacira at its current $29.00 price tag and billion dollar market cap.

Pacira’s Exparel was approved by the FDA in 2011 for specific uses in post surgical pain management, including for removal of hemorrhoids and bunions. Exparel’s ability to facilitate delayed and reduced use of opiate pain killers has caused the company and Wall Street analysts to project a market opportunity of$1 billion in revenues.

Pacira’s Exparel product was commercially launched in April 2012. Sequential revenue growth has been in the double digits but off of a very low base. Even by the end of its first year, the product has only just broken though $7.8 millionper quarter in sales.

The reason that this is problematic is that the benefit from Exparel had been expected to be quite monumental in that it would be an easy to implement and dramatically improved solution vs. opiates and Patient Controlled (“PCA”) alternatives.

The fact that after one year, the product has been this slow to be adopted suggests that the product is far more marginal and far less revolutionary than had been hoped.

This view is supported by looking at the repeat order numbers and customer growth numbers.

Of its 819 accounts at present, only 13% have ordered more than 10 times, while only 23% have ordered more than six times. Wall Street analysts have chosen to view this situation as “the glass is 13% full” as opposed to taking the view that “the glass is 87% empty.”

The reason that this is cause for concern is that Pacira has disclosed the total number of surgeries where Exparel could be appropriate is in excess of 40 million per year, suggesting that repeat orders would be both numerous and large. This was the basis for the “$1 billion” revenue prediction.

The magnitude of the revenue stall is evidenced by the fact that Pacira has also disclosed that it already has access and orders in 75% of the top 100 target hospitals. It is therefore not the case that the medical community is unaware of the existence of Exparel.

In fact, Pacira’s three largest customers (out of 819 total) account for fully 55% of revenues.

A similar way to look at this problem is by noting the slowing growth in “new account boxes” per week. When Exparel was launched in April from a base of zero, new account growth was decent at 60 per week.

Yet by December, that growth rate had already slowed to around 20 per week. Even if we factor in slowdowns for Thanksgiving and Christmas, that number remains well below 30 per week and continues to trend lower.

Again, to put this in perspective, Pacira has a target market of over 40 million surgeries per year, yet even with repeat orders, the company is still only showing repeat order boxes in the hundreds per week.

Even if Pacira were selling 10x this amount, it would not be coming anywhere close to achieving a meaningful market share vs. its 40 million surgeries. So even though the sequential growth rate looks good vs. its low base, it continues to be the case that by year end this hoped-for blockbuster drug had achieved a presence that would not even be noticed by anyone, unless they had a very specific reason to be following Exparel sales.

By year end, Pacira had sold just 5,497 boxes of Exparel vs. 40 million potential surgeries.

So in fact, even if Exparel were selling at 100x of where it is now (549,700 boxes), it’s market share would still be just over 1%.

The de minimis market share by year end was not due to any lack of effort by Pacira. In fact, Pacira has had a massive and full blown marketing strategy in effect since well before the commercial launch. Pacira noted the following pre-launch efforts:

Our commercial team has executed on a full range of pre-launch activities for EXPAREL including:

(I) publications and abstracts for the EXPAREL clinical program efficacy and safety, health outcomes studies, and review articles on postsurgical pain management;

(ii) health outcomes studies which provide retrospective and prospective analyses for our hospital customers using their own hospital data to demonstrate the true cost of opioid-based postsurgical pain management;

(III) key opinion leader, or KOL, development programs and advisory boards to address topics of best practice techniques, guidelines and protocols for the use of EXPAREL, educational needs of our physician, pharmacist and registered nurse customers, nerve block clinical studies and additional indications for the future development of EXPAREL and

(iv) education initiatives such as center of excellence programs, preceptorship programs, pain protocols and predictive models for enhanced patient care, web-based training and virtual launch programs.

In addition, Pacira had already developed a 60 person sales force dedicated to Exparel.

The point is that Pacira put forth the biggest and best effort possible. But following its launch in April 2012, Exparel has generated almost no sales relative to what had been projected.

The double-digit growth against the very small base really only translates into a few hundred boxes per week.

And as we have seen with past drug launches, blockbuster drugs tend to be blockbusters from the very beginning because the drugs are novel and fill a much needed void. For drugs that are slow to be taken up, the chances of eventually morphing into a late blooming blockbuster are greatly reduced.

However, there is potential for the addressable patient market to increase beyond its current low level. Pacira is currently evaluating Exparel’s potential for use in knee and chest surgeries. In December, Pacira also announced apartnership with Aratana Therapeutics which will study Exparel’s use as a pain killer in cats and dogs.

It must be kept in mind that Pacira is a company that has never generated a profit and still operates on a negative gross margin. Against this backdrop, the valuation of nearly $1 billion is clearly unsustainable and is likely to contract in the near term.

When quarterly earnings were announced on March 7th, the shares quickly dropped by more than 5%. The concern among investors was that the company had done nothing to reverse its ongoing negative gross margins.

Indeed, Pacira missed on earnings, delivering a loss of $0.50 vs. expectations of a loss of $0.42.

In fact, even this loss of $0.50 was actually the result of several factors which mitigated a substantially larger loss.

Total share count had increased dramatically during 2012 from 16.4 million to30.3 million. When spread out over the greater number of shares, this reduced the loss from what would have been $0.93 to just $0.50. Yet even this $0.50 was still a 20% greater loss per share than had been predicted by analysts.

In addition, 2012 Pacira’s financials actually benefited quite substantially from the termination of two partnerships, both of which were terminated in 2012.

As a result of these partners walking away, Pacira was able to immediately realize a total of $18.3 million in revenues from “collaborative licensing and development.” Each of these involved revenues which had previously been treated as “deferred revenues.” These revenues are now history and will no longer be recurring. In fact, the amount recognized from collaborations is actually slightly greater than Pacira’s total revenues from actual “product sales” which will be recurring.

Despite this miss and the impact of helpful mitigating factors, analysts were quick to raise their share price targets on Pacira by nearly 50%. Yet with share price targets of $32.00-$33.00, the current share price is now just 10% below analyst targets for 1-year performance.

Following the 5% drop into the $24.00 range, the analyst upgrades caused Pacira to jump as much as 20% to over $30.00

There are quite a few near-term factors which the analysts seem to be ignoring as they take a long term and hopeful view for eventual profitability and material revenues.

Marketing expense is substantial, but is not the element which dominates the equation. In most cases, early stage pharma companies must expend an amount which is greater than their early stage revenues in order to successfully market their product and grow their revenue stream.

In Q4, Pacira spent $13.3 million on SG&A, well above the Q4 product sales of $8.2 million. For 2012, Pacira spent $46 million on SG&A, which is well more than double the $18.1 million in product sales. But again, this is not the problem.

Instead, the real problem is that unlike most one-product pharma companies, Pacira also suffers from a negative gross margin. Pacira is actually selling its drug at a price which is less than the cost to manufacture it. In fact, for Q4 Pacira had a negative gross margin of -18%.

The reason for this is that Pacira still incurs fixed costs of around $30 million for manufacturing Exparel, along with variable costs of around 10-15%.

On the recent conference call, it was noted that:

In 2013 and 2014 as we’re putting Suite C online, that fixed cost number may move around, may tick up a little bit, as I indicated, because we’re doing those two things in parallel. But as we get beyond into ’14 and we’re operating only in Suite C, we should have just a fixed cost number that might be in the 30, $35 million range. We’ll have to see as we go forward here.

What this means is that the negative gross margin will continue until such time as there is a substantial ramp up of sales of Exparel.

Making this goal a reality will certainly take both time and luck. On theconference call, the CEO noted that:

We are on track to break even during 2014 and we continue to believe that Exparel represents a blockbuster platform for post-surgical pain control.

The key takeaway from this is that for at least 1-2 more years, we should not expect any profit whatsoever from Pacira. An eventual profit from Pacira will no doubt depend upon Exparel achieving “blockbuster” status.

Both Pacira management and Wall St. analysts have conducted a bottom up analysis of the post surgical pain management market and have come to a conclusion that Exparel represents a “$1 billion opportunity” – i.e. a blockbuster.

In fact, many drug companies across a wide range of products regularly conduct a similar type of analysis and the results are always very large revenue predictions.

Yet when we look at the overall drug market from a top down perspective, we can see that billion-dollar drugs, which are so commonly predicted, are seldom realized in the real world. This is just an observable fact in the marketplace based on actual sales data.

As noted by a recent article at the Pharmacy Times, in order to make the list of “best selling drugs of 2011” a drug needs to reach revenues of just $2.7 billion. Any drugs with revenues in the $1 billion range are also very close to the best seller list. Yet in order to get to this level, Pacira will need to quickly increase annual sales by about 300x.

In early 2012, investors began showing caution when anticipating near term revenues from new drug launches. The caution was well deserved. Even drugs which saw hundreds of millions in sales in their first quarter post launch saw their share prices decline from previously run up prices.

Shares of Vertex (VRTX) had ended the year 44% below their 52 week high, even though it had achieved record breaking sales of $420 million for just its first quarter on the market.

Regeneron (REGN) launched its macular degeneration drug Eylea and within just 6 weeks, it had achieved total sales of $25 million.

By contrast, Pacira ended its first year with just $14.6 million in total sales of Exparel.

Now it is 2013 and risk appetite has increased dramatically among investors, yet a January article entitled “Drug Launch Failures: A Rising Trend” shows that this optimism may have gotten ahead of itself.

The fact that Exparel has been on the market for a full year and has only generated revenues of $14.6 million basically tells us in advance that its blockbuster potential has been dramatically overestimated by both management and by analysts.

This is all the more applicable given that these small revenues result from Exparel’s status as a full-price solution without any current generic equivalents.

Exparel’s revenues will likely to continue to show continued steady growth off of its very low base. Yet even if revenue growth were to suddenly jump to exponential levels, it would take years to come anywhere close to what is being forecast.

And the overarching reality is that if the product was not an immediate success when launched, then there is no new catalyst which would cause growth to suddenly become exponential.

Still a small cap company with growing pains

Now that its market cap is approaching $1 billion, Pacira will be viewed by many as an emerging mid-cap stock. But while the stock appears to be a mid cap, the underlying company still bears all the hallmarks of a small-cap company with many of the predictable challenges and growing pains.

In 2012 and prior to the launch of Exparel, Pacira had been dependent upon both DeopDur and DepoCyte for its revenues. But then its partners Novo and EKR terminated their partnerships with Pacira.

Pacira subsequently disclosed that:

We do not expect our currently marketed products, other than EXPAREL, to generate revenue that is sufficient for us to achieve profitability because we expect to continue to incur significant expenses as we commercialize EXPAREL and advance the development of product candidates, seek FDA approval for our product candidates that successfully complete clinical trials and develop our sales force and marketing capabilities to prepare for their commercial launch.

Yet these terminations actually had the effect of boosting the revenue which Pacira was allowed to report to investors. Revenues which had previously been accounted for as “deferred revenue” were able to be immediately recognized in full.

On the manufacturing side, it can also be seen that Pacira is facing similar challenges to many of its peers with a fraction of the market cap. It is the manufacturing difficulties that have caused Pacira to sell its only commercial product at a price which is below cost. This is still a work in progress.

Also in 2012, the Medicines and Healthcare products Administration conducted a standard inspection of Pacira’s manufacturing facilities and noted certain “critical deficiencies.” The result was a cessation of manufacturing activities for DepoCyte along with a selective product recall.

As with many small-cap companies, much of the valuation for Pacira lies in hopes and expectations that there will be additional applications that may expand the revenue potential. Yet investors often fail to appropriately monitor and handicap these new developments.

Internally, Pacira also has made use of a number of notably small-cap business practices such as related party transactions.

For example, in reality Pacira only retains a part time Chief Medical Officer who acts as a consultant rather than an employee.

Pacira’s Chief Medical Officer, Gary Patou, is actually a Managing Director withMPM Capital, an investment fund which owns shares of Pacira. Under the terms of his “consulting agreement” with Pacira, the Chief Medical Officer is only required to spend up to 50% of his time working for Pacira.

Pacira CEO David Stack is also a Managing Director from MPM. Separate from that he also has his own company called “Stack Pharmaceuticals” where he serves as Managing Partner. The StackPharma (“SPI”) webpage discloses Mr. Stack’s roles as follows:

Through an SPI engagement, he is currently serving as President, CEO, and a member of the Board of Directors of Pacira and is also a Managing Director at MPM Capital.

In addition, Dave is a Director of Bio-Imaging Technologies, Inc., PepTx, Inc., Molecular Insight Pharmaceuticals Inc. and Elixir Pharmaceuticals Inc.

Under the original consulting agreements with Stack Pharmaceuticals, Pacira ended up paying Stack over $500,000 for items such as office space, a telephone system, work on its website and research for Exparel.

Stack Pharma continues to use the same street address that Pacira uses on its SEC filings, which is at #5 Sylvan Way in Parsippany, NJ.

Previously, Pacira’s Vice President, Commercial, Taunia Markvicka also came from David Stack’s Stack Pharmaceutical, holding a dual role between Stack and Pacira.

Pacira Board Member Gary Pace also receives a large amount of consulting income from Pacira which is separate from the income he receives for being a director. His consulting income has been rising very quickly.

In June 2011, the original agreement provided for $5,000 per month in consulting income plus the right to receive 10,000 shares.

Within 9 months, the income was doubled to $10,000 per month along with a doubled 20,000 shares.

Within a few months of this, these amounts were again revised upwards to $15,000 per month (with a removal of the annual cap) along with a substantial 70,000 shares of Pacira.

So that ends up being $180,000 per year plus options on over $2 million worth of stock being awarded to a board member for the separate (non-board) consulting services he provides to the company. In addition to that, Mr. Pace is eligible for a $200,000 bonus in connection to the Suite C manufacturing facilities being built by Pacira.

In the proxy, it was noted that:

As a result of Dr. Pace’s new compensation arrangements, the board determined that he will no longer qualify as an “independent director” under applicable NASDAQ rules. As a result, Dr. Pace intends to resign from his position as chairman of the nominating and corporate governance committee and a new chairman will be appointed at the committee’s next meeting.

With arrangements like these in place, it would obviously be quite inappropriate for Dr. Pace to continue chairing any corporate governance committee.

The role of Governance Chair had previously paid Dr. Pace $10,000 per year prior to his resignation.

In addition to supplying Pacira with its part time Chief Medical Officer and Chief Executive Officer, MPM Capital has also been supplying Pacira with deals.

MPM is a shareholder of Aratana, which will now be collaborating with Pacira on the use of Exparel as a pain killer in cats and dogs.

MPM is also a shareholder and board member in Rhythm Pharmaceuticals which also recently entered into an agreement with Pacira.

Yet despite the decidedly small cap impression left by this series of related party issues, Pacira management has taken a notably large-cap approach to executive compensation.

For the prior two years, compensation to the top three executives exceeded $4.5 million even though Pacira continues to operate with a negative gross margin and at a time when annual revenues were only $15 million.

Likewise, directors have also made out well, with total director compensation of around $1 million for the past two years, as disclosed in the last proxy.

In addition, option grants were quite substantial in 2012. During 2011, there were 395,000 options issued, taking the balance of options outstanding to 2.3 million.

Yet in 2012 alone, there were 2.1 million new options granted, bringing the total balance of options outstanding to 4.0 million. Of these, 3.9 million are vested as of December 31, 2012.

This compares to a total outstanding share count of 30 million, so roughly 13% of the total current share count. The average exercise price is just $7.78.

Conclusion

Pacira has an interesting product in Exparel. The product may allow use of opiates which is either delayed, reduced or both. Yet the very slow adoption of the drug to date demonstrates that the drug will most likely fall well short of its hoped-for blockbuster status.

The stock price has soared due to optimism over its “billion dollar” prospects and due to a hyper bullish market for development stage drug companies.

With the stock having tripled to close to $30.00 and a $1 billion market cap, it seems that the market is still ignoring the fact that Pacira has negative gross margins and no prospects for profitability for the next two years.

Analysts from the company’s investment bankers have been quick to revise their share price predictions upwards, even when earnings targets have been missed by a wide margin, and even as realized revenues have been minimal and have generated negative gross margins.

When the market cap of a small-cap company soars, investors often forget that the underlying company may still be operating as a company with very small-cap characteristics and small-cap risks.

With Pacira, these elements include:

- numerous related party transactions

- a part-time Chief Medical Officer

- tremendous customer concentration

- product failures and material cancelled partnerships

- regulatory failures and manufacturing risks

The initial progress made with Exparel certainly justifies a price higher than the $10 level where it was last year, but still well below $20.00 given the negative gross margins and slow uptake of the drug.

With the price of Pacira hovering at close to $30.00, a correction of at least 20-30% seems very likely as well as justified in the near term.

On the upside, with a price of near $30.00 there is very little headroom for further upside. This is particularly true given that the current $29.00 share price is now just 10% below the recently increased analyst targets of $32-33.

PCRX: Why are insiders selling ?

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Last week I published an article noting several sell signals which were emerging at Pacira Pharmaceuticals (PCRX), which was closing in on a triple since 2012. In just the past few weeks the shares have risen by more than 50%, to $30.00 from $20.00.

Following my article, it was disclosed that MPM Asset Management, which employs both the CEO and CMO from Pacira, had begun selling 500,000 shares at $27.86. In addition, Pacira General Manager John Pratt sold 100% of his remaining shares at $28.46.


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The previous key sell indicators had been the onset of insider selling by anchor investors Sanderling Ventures along with a $120 million equity-linked financing by Pacira itself. This could lead investors to believe that insider selling might be set to continue.

Even Uber-Bull Jim Cramer noted that with Pacira trading at $28.00 it was time to “take profits”.

In February, BioWire noted that Pacira’s $676 million market cap looked “quite ridiculous” citing its sales slowdown and negative gross margin. Yet now the stock is valued at $1 billion.

Following the release of a wide earnings (loss) miss, the shares fell by as much as 5% into the $24.00 range. But the stock has been recently buoyed by analyst upgrades to as high as $32.00 by Wedbush and Jefferies, along with a conference presentation by Pacira at Barclay’s.

Following my article, MPM Asset Management disclosed a sale of 500,000 shares at a price of $27.86. That trade had crossed in after-hours at a 5% discount to the closing price and represents a discount of 8% to the current price.

In a subsequent sale, General Manager John Pratt sold 100% of his remaining shares in Pacira at a price of $28.46, netting himself over $266,000 in proceeds.

Buy / Sell Reported Symbol Insider Shares Average Total
SELL 3/14/13 PCRX Pratt John 9,375 $28.46 $266,812
SELL 3/13/13 PCRX MPM Funds 500,000 $27.86 $13,930,000
SELL 3/11/13 PCRX Sanderling Venture Funds 374,511 $27.73 $10,384,290
SELL 1/25/13 PCRX Sanderling Venture Funds 500,000 $18.93 $9,465,000
BUY 4/17/12 PCRX Pace Gary 10,000 $9.75 $97,500

The sales by MPM are the most telling.

MPM has long been an anchor investor in Pacira. But of much greater importance is the fact that both Pacira CEO David Stack and Pacira CMO Gary Patou are in factManaging Directors at MPM. While working for MPM, the CMO works only part time for Pacira.

As a result of this involvement, it is safe to say that among insiders, MPM has far greater insight into Pacira than any other fund.

We can now see from the SEC Form 4 filings, that insiders have now sold $25 million worth of their shares in the month of March alone. The last time an insider purchased shares was nearly one year ago, consisting of just 10,000 shares at a price of $9.75.

With the share price now sitting within just a few percent of even the highest analyst targets, it is clear that the upside is now limited in the foreseeable future while the downside is considerable. Following its recent 50% rise, there are no new results or developments expected from Pacira in the near term.

The fact that this rise in the stock has occurred along with the market rising 10 days in a row has likely not been lost on the insiders as they sell.

In the current market environment, it seems that analysts view virtually every traded equity as a compelling buy regardless of its price or recent rise in valuation. Any time a share price moves up to its target, analysts simply re-raise the target to a higher level.

But in the case of Pacira, we can see that this company represents an investment banker’s dream client in terms of future financing needs. Pacira’s historicalinvestment bankers have included Barclay’s, Jefferies and Wedbush.

The company now sports a $1 billion market cap, which means that it is large enough to justify meaningful 9-figure financings in terms of investment banking fees. And it is also clear that the financings will need to continue due to Pacira’s minimal revenues of only $10 million last quarter which were accompanied by a $16 million loss.

These losses are quite obviously set to continue given that Pacira continues to sell its product at a negative gross margin. Even Pacira management noted on its conference call that it hopes to achieve breakeven only in 2014. If there is a profit to be had we must then wait until 2015.

The real question becomes: “Why are those who know the most about Pacira also the ones doing the most selling ?”

The question they are likely asking themselves regarding selling is: “If not now, then when?”

As the share price rose, the company was quick to make use of the share price rise to issue equity securities raising $120 million. At that time Sanderling began selling. Now the fund which employs both the CEO and the CMO has begun selling shares and even employees such as the General Manager are selling 100% of their shares.

The share price has benefited from every tailwind possible including bullish upgrades despite an earnings miss and a 10 day consecutive rise in the stock market.

With the share price now closing in to just a few percent of the newly upgraded share price targets, and with no new corporate developments expected in the near term, the shares have simply run out of further upside catalysts.

Aside from the selling insiders, outside investors will now need to pause and evaluate the $1 billion valuation in the context of a stock that sells at negative gross margins with quarterly revenues of just $10 million.

As BioWire noted at $20.00, before the 50% rise, the valuation continues to be ridiculous. It is likely that we will see ongoing insider sales to cash in on this stock market gift to share holders.

Outsiders now need to consider whether or not they should be listening to the company’s investment bankers who are telling us to buy the stock at ever higher prices, or whether they should be listening to the close insiders who are now cashing out of their stock.

Dose Of Reality: Opko Set To Pullback

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Shares of Opko Health (OPK) have risen 65% in the past three months as a string of domestic and international acquisitions, along with a greater collaboration with Bristol Meyers (BMY), has opened up numerous new pathways for the company.

Opko’s prospects as a company continue to be bright, however at the current price of around $7.00 the market cap of Opko now exceeds $2 billion.

This is in spite of the fact that Opko has recently disclosed that it does not expect to become profitable in the near term, which implies that massive revenues (as predicted by various authors) are not on the near term horizon.

As shown on the Form 4′s, insiders have now begun selling, with Opko’s VP of Finance and Chief Accounting Officer selling $336,000 of stock on February 1st.

Based on the information below, at any prices above $5.50 Opko is a clear sell. Although at prices of $4.00-$5.00 the stock likely becomes an interesting buy once again.

Even those who are very bullish on Opko’s long term prospects are now leery of the recent run-up and the lofty share price. Various signals are now emerging that the stock is headed for a significant correction.

The signals include the following:

  • Insider selling: According to the latest Form 4, on February 1st, Opko’s VP of Finance and Chief Accounting Officer, exercised his options and immediately sold 100% of the shares underlying at $6.72. Total shares amounted to 50,000, resulting in proceeds of $336,000.
  • Heavy share issuance by Opko: Opko has been taking advantage of the run-up in the share price to issue 20 million shares for its acquisition of Cytochroma at $4.87 and another 25 million shares via a convertible bond at $7.07. These representsissuance of over 45 million shares all in the month of January alone.
  • Negligible buying by Frost: Purchases from Dr. Frost have continued, but the vast majority were in 2012 at prices of $4.00-$5.00. Only 70,000 shares were purchased above $6.00. Dr. Frost’s historical position is greater than 140 million shares.
  • Huge overhang from potential sellers: The recipients of shares from recent acquisitions along with the convertible bond shares now create a massiveoverhang of more than 50 million shares.

Author Kevin Quon has been bullish on the stock but also noted in his most recentarticle the market cap has become difficult to justify. The Motley Fool notes that Opko has “received an alarming one-star ranking“, meaning that it is expected to be a notable under performer. Author Josh Ginsberg continues to be bullish on Opko’s business prospects but notably made no evaluation of the share price following the run-up to $7.00 and $2 billion in market cap.

Clearly these comments do not reflect a lack of opportunities for Opko nor do they reflect a lack of faith in Dr. Phillip Frost or Opko management. Just about anyone familiar with Opko or Dr. Frost continues to be bullish on the long tem prospects for the company.

Instead bearish comments are a reflection on Opko’s share price, which has simply moved way too far way too fast and is now due for a meaningful pullback.

Back in November, Cramer noted that the company was a “$4.00 and change” stock but cautioned viewers

don’t jump all over this thing because you will lose money if you chase it up to $5.00 or something silly like that

That was just 10-12 weeks ago and now the stock is as $7.00. On his most recent show featuring Opko, Cramer continued to be positive on the company’s prospects but stopped short of calling it a buy.

The reasons for his restraint are twofold.

First, the $2 billion valuation now creates far more chance of nea