FDA Votes 'No': Is This The End Of Amarin?

| About: Amarin Corporation (AMRN)

I pointed out in my last article what a pressure cooker Amarin (NASDAQ:AMRN) was going to be put in, should the ADCOM panel on Wednesday not give the nod for Vascepa to be approved in its ANCHOR indication. The ANCHOR indication would have exponentially expanded Vascepa's patient population, and surely would of been one of the most positive catalysts for the company since Vascepa's initial FDA approval.

On Wednesday the vote was 2 "yes", and 9 "no" for recommendation of ANCHOR approval. The panel chair was one of the two "yes" votes, for what that's worth. It won't be much for Amarin shareholders. After sparring all day on questions regarding the safety of Vascepa and the mineral oil placebo's effect on how the efficacy of Vascepa is viewed, Amarin is going to be forced to wait until 2016 for the results of its REDUCE-IT study before approval of this new indication.

This outcome puts enormous pressure on Amarin. It also shatters a lot of hopes and bullish arguments for the company - Amarin is likely to open Thursday down significantly. Also, to give credit where credit is due, it validates Adam Feuerstein's predictions of the drug not getting immediate recommendation for ANCHOR.

Aside from not having the patient population accessible, it forces Amarin to begin thinking about future financing again, as well as making sure that it continues to execute with Vascepa's current patient population. If Amarin reports a cash burn near what it has spent over the past few quarters, financing is going to be a major issue.

This is a road that leads toward eventual dilution and many longs throwing in the towel, I guessed earlier in the week. I'd look for the market to correct from its already semi-lofty valuation of the company at $5/share (about $855 million market cap), and wind up trading in the low $3 region until Vascepa could continue to show traction with its current patient population.

The stock comes off its halt for trading on Thursday. The big sellers (and put buyers) before the briefing clearly had a "feeling" that something negative is was going to be coming down the pipeline.

Amarin has now become a much more speculative investment - as it relies on hopeful traction with current Vascepa prescription revenues and results of the REDUCE-IT study that aren't due for another year and a half. I assure you, for Amarin longs that decide to hold on, that's going to be the longest year and a half they've waited in a while.

In addition, Amarin now really has "all eggs in one basket." If Vascepa prescriptions do not continue to perform well, and if the company cannot turn Vascepa into somewhat of a revenue center in the coming months, there is a risk of total loss for Amarin investors.

Aegis Capital, who previously had a $35 price target on Amarin with a "buy" rating, has downgraded to "hold". SunTrust has downgraded Amarin to "neutral" from "buy".

I remain on the sidelines here and would suggest doing the same until we can gauge what the company's plan - likely aggressive cutting and continued focus on Vascepa's current indication - will be. Amarin as a long investment is back into speculative territory, with a major cash burn and significantly reduced potential patient population.

Amarin will host a conference call on Wednesday evening, at 7PM, to review the results of the ADCOM panel.

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 (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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