The rangebound action continues for Amarin Corporation plc (NASDAQ:AMRN) as we head into year-end. Our sense remains relatively fixed on the idea that the company is playing a strong hand in front of a likely bidding war for control of Vascepa in the ranks of the big pharma landscape.
The only factors that really stand in the way of that picture are dilution potential and the possibility that the FDA does not grant an expanded labeling for Vascepa due to concerns about the lack of an inert placebo in its famous Reduce-It trial.
Amarin Corporation plc (NASDAQ:AMRN), as we have recently covered, has strong defenses against both of those bear factors.
In the first place, the company has already proven that it can go to the market for money without making much of a dent in the tape when it conducted a $200M offering in November with little issue.
Perhaps more importantly, the ramp in expenses that will unquestionably accompany amplified marketing efforts for Vascepa is not a bottomless pit of dilution. We have seen similar cases before where a promising drug was the death of an otherwise sturdy name simply because the runway length was greater than the solvency potential and confidence interval in the market.
In this case, the company is not planning on funding the full blossoming of the flower for Vascepa. It simply needs to gain leverage at the table by proving that it can build a long enough runway if need be.
In addition, because the results for Reduce-It were so dramatic and visible in the media, we have already seen doctor polls suggesting much of the medical community is very aware of the potential along with the cost efficiency.
The bulk of a marketing ramp is about awareness. One might even argue that the mineral oil placebo issue increased the visibility of the drug in the marketplace, thus dramatically reducing the necessary marketing costs of the initial ramp.
Turning to the second issue, as we have noted, the FDA issued prior approval of the precise placebo used in the Reduce-It trial before the trial got underway in the form of a special protocol agreement (SPA). Since we are talking about a substance – mineral oil, for crying out loud – that is anything but an unknown quantity for medical researchers at the FDA, the likelihood that this is all some sort of surprising problem in their evaluation is somewhere between nothing and nothing as we see it.
Hence, the notion of a serious problem in obtaining the expanded labeling is probably overblown.
Finally, as we have also covered, the company just won a court case that sets precedence allowing Amarin to market directly to doctors without the expanded labeling. So, even if they don’t get it, they can still make the case.
Any way you look at the situation, we remain firmly in the bull camp here.
Top Down View
Amarin Corporation plc (NASDAQ:AMRN) trumpets itself as a biopharmaceutical company that focuses on the development and commercialization of therapeutics for the treatment of cardiovascular diseases in the United States.
The company’s lead product is Vascepa, a prescription-only omega-3 fatty acid capsule, used as an adjunct to diet for reducing triglyceride levels in adult patients with severe hypertriglyceridemia. It is also involved in developing Vascepa for the treatment of patients with high triglyceride levels who are also on statin therapy for elevated low-density lipoprotein cholesterol levels.
Amarin Corporation plc sells its products principally to wholesalers and specialty pharmacy providers through direct sales force. It has collaboration with Mochida Pharmaceutical Co., Ltd. for the development of EPA-Based drug products and indications.
The company was formerly known as Ethical Holdings plc and changed its name to Amarin Corporation plc in 1999. Amarin Corporation plc was founded in 1989 and is based in Dublin, Ireland.
Amarin Corporation plc (NASDAQ:AMRN) managed to rope in revenues totaling $55.4M in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top-line growth of 16.3%, as compared to year-ago data in comparable terms.