Amarin shareholders were counting on management to put in a strong performance during the third-quarter conference call on Nov. 8, and the executive team didn't disappoint. CEO Joseph Zakrzewski was calm, cool, and collected as he gave the rundown on Amarin's state of affairs — and he didn't shy away from discussing Vascepa's NCE status or the company's plans to commercialize its lipid-lowering drug. Here are the key takeaways from the report:
Will Vascepa see orange in November?
Investors have heard about this ad nauseum by now, but Vascepa's New Chemical Entity, or NCE, status remains the single most important catalyst for Amarin today. This issue has latched on to Amarin's shares like a barnacle, and this stock is destined to either rise or fall with the Food and Drug Administration's decision.
Zakrzewski pointed out that, while the full five years of market exclusivity granted by the NCE designation would add some security going forward, Vascepa really only needs patents to shield it from generic competitors. Fool contributor Brian Orelli shared the same point of view when analyzing this stock back in August, but the market simply doesn't agree.
With regard to the delay, the FDA hasn't dragged its feet in making this decision — it's just really hard to determine whether this drug qualifies as an NCE; Vascepa is mostly made up of a compound called EPA. GlaxoSmithKline's drug Lovaza is partially made up of EPA and was already approved by the FDA a few years ago. Therefore, it's hard to say if Vascepa's purified form of this chemical counts as a "new" drug under the official NCE guidelines.
Amarin's share price will continue to move on speculation, but investors will really just have to sit tight and wait to hear from the FDA. The "Orange Book" is updated mid-month, so we might receive news soon. Just remember that, while Amarin may have strong long-term prospects, the NCE issue presents a classic binary event, and shares could either be hit if it's denied or soar if it's granted.
While the NCE drama has undoubtedly delayed buyout and partnership negotiations with big pharma companies, Amarin is charging ahead with its plan to get Vascepa on the market in the first quarter of 2013. It has already started to grow the drug's inventory and will soon assemble a sales team. Some investors might be squeamish at the prospect of Amarin trying to sell Vascepa without the marketing muscle of a bigger company. However, the executive team has plenty of experience in this field and might be able to pull it off successfully.
One long-term topic that investors might be wondering about, the ANCHOR indication, was also discussed in the report. Amarin is making progress with its studies, and it looks like it will apply for this expanded use in February 2013. ANCHOR could unlock much more value for Vascepa in the years to come, but with a potential PDUFA date toward the end of next year, shareholders should focus on the NCE outcome and any news regarding a partnership or buyout for now.