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Amarin Looks Like a Fish Out of Water

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There are two key components to the drug development process: creating, testing, and getting a drug approved by the Food and Drug Administration; and the commercialization and subsequent launch of that drug.

In previous years -- before the Patient Protection and Affordable Care Act became law and competition among biotechnology and pharmaceutical stocks was far less fierce -- the latter didn't matter as much. With the drug approval process much slower in the past, simply getting a drug approved gave it a pretty good chance of success. That isn't the case anymore.

Today, having the right marketing team and strategy -- as well as properly pricing your drug to encourage insurance companies to pick up the tab and encourage potential patients to inquire about the treatment with their physician -- is just as important as the drug approval itself.

Marco... Polo... fish out of water!
Thus far, the promise of Amarin's (NASDAQ: AMRN  ) LDL-reducing fish oil capsule, Vascepa, has failed to live up to the latter part of the bargain.

Let me preface this by saying that we're in about the second inning of a nine-inning game, so my call is certainly going to be seen as a bit premature. But if Amarin doesn't get its act together quickly, it may find itself left in the deep end of the pool by itself while its peers swim away.

Last night, Amarin delivered its second-quarter results to investors which were, based on Wall Street's expectations, mixed. The Street had been calling for an EPS loss of $0.40 with revenue projected at $8.2 million. What Amarin delivered was a much smaller loss of $0.26, but just $5.5 million in product revenue. Before you go trumpeting Amarin's smaller-than-expected loss, consider that its $5.5 million in product revenue, while 135% more than it delivered in the first quarter, still fell $500,000 below the lowest of nine Wall Street revenue estimates. There were obvious positives as you might expect from a recently launched drug, including a more than quadrupling of prescriptions written to 47,335 from 10,484, but it nonetheless was another quarter of missed revenue expectations.

Amarin needs an "Anchor"
The biggest current growth driver for Amarin is its ongoing Anchor study, which looks to expand Vascepa's indication beyond just treating patients with hypertriglyceridemia and into treating patients with mixed dyslipidemia with triglyceride levels between 200 mg/dL and 499 mg/dL. This expanded drug approval, which in trials has shown promise, is the key for Amarin to greatly expand its target audience.

The question is even with Amarin filing for a supplemental new drug application and getting a PDUFA date in December, will it be able to capitalize on a new approval given how weak sales of Vascepa have been to patients with high triglyceride levels thus far? The company certainly has a large marketing team -- 275 strong -- but competition and skepticism over the effectiveness of fish oil supplements is growing.

Source: Pixabay.

A sea of worry
Having recently completed a hefty secondary offering, which helped raise nearly $122 million for the company, its cash situation has never been brighter. What stands as the biggest worries for Amarin and Vascepa are staunch existing and upcoming fish oil drugs, as well as growing skepticism as to the long-term effects of fish oil on cardiovascular well-being.

On one hand, Vascepa will have to go up against longtime fish oil market share leader GlaxoSmithKline (NYSE: GSK  ) , whose Lovaza accounted for more than $920 million in sales last year. After nearly two full quarters since its launch, Vascepa hasn't even reached 1% of Lovaza's full-year totals despite Glaxo running into austerity-induced weakness in Europe.

In the other corner, we have AstraZeneca (NYSE: AZN  ) , which recently agreed to purchase Omthera Pharmaceuticals (UNKNOWN: OMTH.DL  ) for $323 million with the possibility of an additional $120 million in milestone incentives. The reason for this purchase was to get a hold of epanova, Omthera's late-stage fish oil candidate. Early last month, Omthera filed for a new drug application for epanova, meaning that Vascepa's FDA-approved competition may be about to increase in just a matter of months.

Perhaps the biggest worry, though, has been numerous studies -- including a meta-analysis of 20 clinical studies published in the Journal of the American Medical Association -- that omega-3 fatty acids provided little benefit to reducing heart attack, stroke, or risk of death. A more recent study from the Fred Hutchinson Cancer Research Center even purported a link between patients who took omega-3 fish oil supplements and an elevated risk of getting more aggressive forms of prostate cancer.

What's a shareholder to do?
There are really two ways to approach this: as an existing shareholder or as a prospective investor on the outside looking in.

If you're a current shareholder, the primary investing thesis for buying into Amarin hasn't changed. Although its launch has been somewhere between blah and mediocre, the market potential of an indication expansion, as well as the broad audience potential of fish oil drugs is too large to ignore. Even with the ongoing losses and negativity surrounding some of the aforementioned studies, the chances of your long-term investment thesis being disrupted by the past two quarterly reports is likely very small.

However, if you're a prospective investor on the outside looking in, I would suggest that your best course of action might be to take the middle road and wait patiently for an FDA decision on its sNDA application. An expansion of Vascepa's indications isn't a sure thing -- nor is its ability to greatly improve its quarter-over-quarter product sales growth. As physicians write more prescriptions for Vascepa, Amarin's production costs for bulk orders will drop and its margins should rise, reducing its loss per share. The big concern is ultimately whether Amarin can stand up to investors' lofty expectations. So far, that's two quarters in a row that it hasn't.

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Read/Post Comments (6) | Recommend This Article (8)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On August 09, 2013, at 5:33 PM, BiotechWill wrote:

    This article looks like a bit of a fish out of water. Anyone with a bit of sense who can read at higher than an eight grade level knows that your so-called "studies" don't hold an ounce of meaning for Vascepa or Amarin, based on what the studies looked at, what they studied, etc - perhaps if you had been listening to the conference call last night you could put together a bit of a better article.

    Although revenues were not what expected, it is also a bit silly to act like the EPS didn't matter. When you factor in the GAAP measures Amarin using for reporting sales, the insurance gains, the increasing sales, and the timeframe, the future is looking pretty bright.

    Your attempts at bringing Epanova and Lovaza into the picture are also "foolish" - Epanova isn't removed, and Lovaza is an inferior product. Give it time.

    Finally, recommending that a prospective investor should wait would have to be based more on that investor's risk tolerance and goals. An investor looking to buy a stock with a lot of upside should be in at these prices, as opposed to following your truly "foolish" advice. On a plus though, at least unlike the other foolish article published today, you managed to get the EPS right, so that is something.

  • Report this Comment On August 09, 2013, at 5:37 PM, BiotechWill wrote:

    Also, if I could type - I would have written Epanova isn't approved nor as effective in studies as Vascepa, and Lovaza is also not as effective as Vascepa, beyond the fact that it raises LDL-C.

  • Report this Comment On August 10, 2013, at 9:01 AM, rayrivers wrote:

    I guess the Fool who wrote this shallow article on AMRN is better informed than the major firms that all have buy recommendations on the company. Its no wonder they are called Fools...

  • Report this Comment On August 10, 2013, at 11:55 AM, KapowCashmoney wrote:

    You purposely omitted in your article that Amarin's CEO did address the many negative fish oil studies that are out there,and how it has no relation to Vascepa.Be a man, an honest man,and don't provide half-arse articles to suit your bear thesis story.

    Nobody knows where the road will end for Amarin,but you should be unbiased and fair in your reporting, and you are far from that.

  • Report this Comment On August 12, 2013, at 2:40 PM, astronut666 wrote:

    I quit reading at "ongoing ANCHOR trial" and "large marketing team of 275" - clearly the author has no clue, rather an agenda.

  • Report this Comment On August 13, 2013, at 12:08 PM, horticultor wrote:

    Is this Adam Feuerstein writing under an assumed name?

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