Jefferies Update 07/06/2016
Amarin Corporation (AMRN) Jefferies 2016 Healthcare Conference Takeaways
At our annual healthcare conference, John Thero, CEO, discussed the outlook for Vascepa for '16/beyond. AMRN remains focused on improving Vascepa visibility and uptake, particularly with the help of the ANCHOR and JELIS data in mixed dyslipidemia, and reiterated rev guidance of $105-120M for FY’16.
REDUCE-IT remains a key focus, and as previously reported it has reached 60% of primary events and interim analysis by the DMC is on track for Sep/Oct. AMRN Remains Focused on Improving Vascepa Visibility and Uptake; REDUCEIT Remains a Key Focus: John Thero, CEO, discussed the outlook for Vascepa for 2016 and beyond.
AMRN remains focused on improving Vascepa visibility and uptake, particularly with the help of the off-label promotion in mixed dyslipidemia using the ANCHOR and JELIS data, and reiterated revenue guidance of $105-120M for FY’16. Focus continues to be on the REDUCE-IT outcomes trial; as previously reported, AMRN has reached the onset of ~60% of the target primary cardiovascular events in the study, and the prespecified interim analysis by the DMC is on-track for September/October. AMRN reiterated that the interim bar to stop the trial for overwhelming efficacy is high, and noted that it in addition to meeting the bar on the primary endpoint would prefer to see certain secondary endpoints be favorable as well. We expect the interim to continue as planned with final analysis expected in early ’18, for which we have a favorable outlook.
AMRN Continuing Partnership Discussions for Ex-US Opportunities: AMRN also noted that discussions with potential partners for ex-US opportunities for Vascepa are ongoing, some of which may have interest pre-REDUCE-IT results. Eddingpharm is continuing the development of Vascepa in China, where there may be significant opportunity and where there is no equivalent omega-3 fatty acid product in the space. AMRN noted that another trial may be needed as a regulatory requirement and it is awaiting to see the design of that trial. According to the agreement, Eddingpharm will pay AMRN tiered double-digit percentage royalties on net sales of Vascepa in the territory escalating to the high teens.
