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Amarin Corp Plc (AMRN) Posts Q1 Loss of 16c/Share; Updates on Ops

May 9, 2014 7:03 AM EDT

Amarin Corp Plc (NASDAQ: AMRN) reported Q1 EPS of ($0.16), $0.02 better than the analyst estimate of ($0.18). Revenue for the quarter came in at $11 million versus the consensus estimate of $11.65 million.

Operational update

Commercialization and regulatory update

Amarin is now available on formulary to over 200 million lives in the United States, including over 100 million with Tier 2 coverage. As the company works to continue to increase the productivity of our sales representatives and work with our new co-promotion partner, Kowa Pharmaceuticals America, the company believes Vascepa sales will continue to grow with current Vascepa labeling. In late 2013, Amarin shifted its main focus to the approximately 7,000 targeted physicians who are responsible for a significant portion of the prescriptions generated for the leading prescription omega-3 therapy indicated for the treatment of severe hypertriglyceridemia. During Q1 2014, prescriptions from targeted physicians increased while prescriptions declined from physicians who were no longer prioritized for details after the company's reduction in sales force size. Normalized prescriptions (estimated) for the quarter ended March 31, 2014, based on data from Symphony Health Solutions and IMS Health, totaled approximately 93,000 and 78,000, respectively. Co-promotion with Kowa Pharmaceuticals America begins this month and, over time, is expected to expand the target physician prescriber base and more than double current sales detail frequency, including resumption of details to physicians not currently targeted by Amarin's sales representatives.

The company also continues to pursue FDA approval of Vascepa for the ANCHOR indication, a second indication as an adjunct to diet and exercise for adult patients with mixed dyslipidemia who despite optimized statin therapy have TG levels between 200 and 499 mg/dL.

REDUCE-IT and other Vascepa-related clinical development

Enrollment for the REDUCE-IT outcomes trial of Vascepa continues at over 450 sites spanning 11 countries. Earlier this year enrollment for the REDUCE-IT trial surpassed 6,800 patients representing enrollment of 85% of the total number of patients for which the study was designed. Results of the REDUCE-IT study will not be available until a specified number of cardiovascular events have been observed. Based on current expectations, unless feedback from pending discussion with the FDA regarding the ANCHOR sNDA results in modification or termination of the REDUCE-IT study, completion of this blinded study is anticipated in or about 2017. Amarin estimates that over $100 million is required to complete this study. While Amarin remains scientifically committed to continuing the REDUCE-IT study, Amarin anticipates that the trial may be difficult to complete in its current form without the expected revenues from the previously anticipated ANCHOR indication, as communicated to the FDA.

For earnings history and earnings-related data on Amarin Corp Plc (AMRN) click here.

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