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The company reported first-quarter earnings Tuesday -- without any revenue, they were a yawn fest of GAAP adjustments -- but management also presented an update on the company's development plans.
You'll recall that AMR101 recently passed two clinical trials: the first in patients with extremely high triglyceride levels, and a second in patients with moderate triglyceride levels. The latter group matters more, because it encompasses a lot more potential patients. Amarin estimates that 40 million people in the U.S. have triglyceride levels higher than 200 milligrams per deciliter.
Unfortunately, Amarin won't be able to gain Food and Drug Administration approval to market the drug for those moderate triglyceride levels when it submits its application in the third quarter. While the drug increases good cholesterol and lowers bad cholesterol -- something GlaxoSmithKline's (NYSE: GSK ) Lovaza and Abbott Labs's (NYSE: ABT ) Tricor and Trilipix don't do -- the FDA will require an outcomes study that's substantially enrolled before it will approve the drug for the less-sick patients.
The company hasn't even started the study, and it expects that it won't be substantially enrolled until the end of next year. In order to get enough outcomes -- heart attacks and the like -- it'll likely have to be a large trial. Amarin ended the quarter with about $130 million, probably not enough to run a large trial and prepare for a launch at the same time.
Raising money through a secondary offering at this point wouldn't be all that costly, but a partnership or a buyout is likely still the best option for the company.
Investors should note when valuing the company that in addition the 126 million ADSs outstanding, there are also nearly 40 million additional stock options and warrants that could be exercised. Given the large increase in share price over the last few months, it seems likely that many of those are in the money. Any potential acquirer will take into account the likelihood that they'll be exercised in the event of a takeout.
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