Amarin Corp. (AMRN) Tops Q3 EPS by 4c, Revenues Beat
Amarin Corp. (NASDAQ: AMRN) reported Q3 EPS of ($0.01), $0.04 better than the analyst estimate of ($0.05). Revenue for the quarter came in at $112.4 million versus the consensus estimate of $110.04 million.
- Record total revenue: Reported total revenue of $112.4 million and $286.5 million for the three and nine months ended September 30, 2019, respectively, representing increases of 103% and 89%, respectively, over the corresponding periods of the prior year. The total revenue reported for the first nine months of 2019 exceeded the full-year results reported for 2018.
- Record prescriptions: Growth in net product revenue was supported by increased prescription levels of Vascepa® (icosapent ethyl) capsules. The increased prescription levels reflect both a higher number of Vascepa prescribers and an increase in the average prescriptions per prescriber.
- Preparing for anticipated label expansion: Assuming that, on or before the previously announced December 28, 2019 PDUFA date, Vascepa’s label will be expanded to reflect cardiovascular risk reduction as demonstrated in the REDUCE-IT® cardiovascular outcomes study, Amarin is taking broad steps to prepare for commercialization of Vascepa as the first therapy to address this important unmet medical need, including preparation for increased education of healthcare professionals and patients. Furthermore, to support FDA’s approval of Vascepa for this expanded indication, Amarin has prepared for, and looks forward to, the FDA’s advisory committee meeting scheduled for November 14, 2019.
- International regulatory activities on track: Amarin continues to target making its submission, before the end of 2019, seeking regulatory approval of Vascepa in Europe. Regulatory review of Vascepa in Canada continues to progress through Amarin’s commercial partner in Canada with approval anticipated near the end of 2019 (late 2019 or early 2020).
- Scientific advancement continues: Thus far in 2019, Amarin has supported more than 40 scientific manuscripts or scientific publications with additional presentations anticipated before year-end, including multiple presentations later this month at the American Heart Associations’ Annual Scientific Sessions.
- Medical community support for using Vascepa to help patients: Following the American Diabetes Association (ADA) new medical guidelines issued in March 2019, leading cardiology, endocrinology and lipidology societies have updated their clinical guidelines or provided varying other forms of advisories that reflect the results of the REDUCE-IT study for patients who despite well-controlled LDL-cholesterol have elevated triglyceride levels (>135 mg/dL) and other cardiovascular risk factors. In Amarin’s view, it is extraordinary to witness this broad level of medical society support prior to FDA approval for this important medical indication. These societies include the National Lipid Association, American Heart Association, European Society of Cardiology and the European Atherosclerosis Society. Separately, an independent drug pricing watchdog group concluded that Vascepa is cost effective for cardiovascular risk reduction even under the most stringent standards of that group, which is rarely achieved in their analysis.
“Our aim is to help as many patients as possible with Vascepa. Accordingly, we are pleased to witness the growth in Vascepa usage as reported in the third quarter. These recent results are laying the foundation for our future growth as we seek to make Vascepa a new standard of care for use in appropriate at-risk patient populations based on REDUCE-IT,” stated John F. Thero, president and chief executive officer. “We are appreciative of the many patients and health care professionals who have reached out to us expressing support for approval of Vascepa for the expanded indication being sought. We are working with leading physicians to ensure that the results of the landmark REDUCE-IT study are well understood by regulatory authorities and their advisors. We recognize that much work remains following the anticipated approval of Vascepa. We remain guided by science and highly motivated by the unmet medical need that we believe Vascepa can address.”
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