Amarin (AMRN 2.03%) announced its financial and operational results from the second quarter after the market closed on Thursday. Here are the key things you need to know from the company's latest update.
1. Vascepa numbers climbing
Vascepa, Amarin's triglyceride-lowering drug, generated sales totaling $5.5 million in the second quarter. This was the first full quarter of sales for the drug.
Amarin reported 47,335 normalized prescriptions during the second quarter compared to 10,484 in February and March. The company also said that more than 72 million people now have access to Vascepa as a tier 2 drug, which means that patients pay a lower co-pay.
Amarin CEO Joseph Zakrzewski highlighted the positives, noting that physicians are increasingly aware of and favorable toward Vascepa. Zakrzewski stated that "since the end of Q1, revenues, prescription levels, prescribing physicians and lives covered under Tier 2 have all more than doubled."
Despite the improvement, sales aren't nearly strong enough yet for Amarin to turn a profit. The company reported a non-GAAP net loss of $54.5 million, or $0.36 per share. Analysts expected a loss of $0.40 per share.
2. Anxiously awaiting Q4
While Amarin works to build up sales for Vascepa in treating super-high triglyceride levels of 500 mg/dL and higher, the big opportunity lies in treating patients with triglyceride levels between 200-499 mg/dL This market could be 10 times larger than that for Vascepa's currently approved indication.
The fourth quarter will be make-or-break time for Amarin in gaining access to the larger market. An advisory committee meets in mid-October to review Vascepa. The Food and Drug Administration is scheduled to announce a decision by Dec. 20.
When the FDA accepted the submission of a supplemental New Drug Application, or sNDA, for Vascepa in treating the lower (but still high) triglyceride levels, the agency stipulated that Amarin's REDUCE-IT cardiovascular outcomes study "be substantially under way." That study is under way, but Amarin doesn't think final results will be needed for an approval of the second indication.
3. What was only barely mentioned
Amarin has gone solo with commercialization of Vascepa so far, but tackling a much larger market presents a tough challenge. As of the end of June, the company had $149.4 million in cash and cash equivalents. It's going to take more than that to fund operations and launch Vascepa for a broader indication.
Management didn't fully address the obvious question: Will Amarin line up a partner or be acquired? The most that Zakrzewski would say on any potential partnerships was that they are "still evaluating" the possibilities.
He was asked, however, about AstraZeneca's (AZN +0.00%) recent acquisition of Omthera Pharmaceuticals, which has its own fish-oil drug. Zakrzewski brushed the question off in large part, saying that the deal probably was more about protecting AstraZeneca's cholesterol drug Crestor than lowering triglycerides.
Prior to the Omthera acquisition, AstraZeneca probably would have been on most observers' short list of potential acquirers or partners for Amarin. Elan (ELN +0.00%) would have also likely been on that short list. The company's chairman, Robert Ingram, stated in May that getting access to Vascepa was "an opportunity we're considering."
However, Elan itself is now being acquired by Perrigo (PRGO +2.50%). No further mention has been made about any potential for buying or partnering with Amarin. Perrigo could be less likely to push for a deal for Vascepa as it processes the absorption of Elan into its organization.
Looking ahead
With Amarin's stock up 5 percent in trading so far today, I expect that low levels of excitement could persist for the near term. A huge uptick in Vascepa prescriptions could turbocharge the stock, but my guess is that we'll have to wait until October's advisory committee decision to see a breakout.
Don't discount the possibility that a larger player will step forward to either acquire Amarin or form a partnership for Vascepa. Any significant news on that front would send shares soaring. For now, though, Amarin is basically staying mum on that topic.
