Biotech is a sector where investors know they are entering a high-stakes game of big risk and big reward. That is particularly the case for the small-cap biotech stocks that have no products and are looking to launch if all of the stars align properly. Amarin Corporation PLC (AMRN) joined in on the painful side of that risk in small-cap biotechs Thursday morning. In fact, its future is now questionable.
Amarin is focused on therapeutics to improve cardiovascular health, and an FDA panel has thwarted some of those hopes for its Vascepa. The U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee voted nine to two against approval of Vascepa capsules for use as an adjunct to diet and exercise and in combination with a statin in the treatment of adult patients with high triglycerides.
The patients were also in the category of mixed dyslipidemia and coronary heart disease, or a CHD risk equivalent. The FDA is scheduled to make its decision on whether to approve the ANCHOR Supplemental New Drug Application on the December 20, 2013, Prescription Drug User Fee Act (PDUFA) goal date for the application. Unfortunately, a vote of this magnitude will dash those hopes.
Amarin did make the reminder that Vascepa currently is approved by the FDA for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Unfortunately, the company's revenues were only $5.5 million in the June quarter and $2.3 million in March quarter. Amarin was at the pre-revenue stage prior to that.
Note that Amarin did have $150 million in cash at the end of June. Unfortunately, that cash is crunching rapidly, as the cash balance was $203 million at the end of March and $260 million at the end of December.
Amarin shares at Thursday's opening bell were down 60% at $2.03, and we have now seen a whopping 30 million shares trade hands. The prior 52-week trading range was $4.50 to $12.96, and its market cap based on the $5.17 closing bell price was already under the $1 billion mark at $892 million. The new market cap is down around $358 million.
Even a few minutes before the open, there had been more than 23 million shares traded in the premarket session. A normal day's trading volume is about 5.4 million shares.