Thanks to RobCOS - IV Board Jefferies just out -Amarin Corporation (AMRN, BUY): Going into Half-Time Show...Continues to Look Fine Based on FDA Presentation
Key Takeaway
FDA presented their review and handled Q&A from committee. FDA presented a rigorous analysis on mineral oil (5-10 slides) and other sensitivity factors (dropouts, etc.) and concluded results of REDUCE-IT are robust and mineral oil would have at worst, a small impact (3%). We remain positive on approval and also believe the "wording" of the label population to be another investor debate but overall not a big impact to consensus, in our view.
Insights
Finishing the first half of the Adcom Panel, the presentation by FDA suggests positive conclusions and we remain confident on approval of label expansion for AMRN. And while one committee doc kept asking/pushing on mineral oil impact on LDL and even blood pressure, FDA continued to suggest it had minimal impact. Interestingly, the committee questions are all aimed at FDA and few - if any - were to AMRN.
The FDA stated: (1) data shows stat sig efficacy results, (2) this is confirmed by multiple sensitivity analyses, (3) mineral oil placebo is unlikely to invalidate the study conclusion, (4) the proposed indication is broader than trial population, and (5) on safety there is higher A-Fib and bleeding but despite this the benefit risk profile remains favorable.
There is at least one doc who keeps asking on mineral oil and on all the other biomarker impacts (e.g., increase in hsCRP, 1mmHg increase in blood pressure, etc.) and FDA essentially said you could look at every little signal and marker and maybe it's an outstanding question, but it's not likely to impact the overall conclusion. And CRP and LDL may or not be independent from each other, so you cannot just take each and add up all the biomarkers and say it's due to mineral oil. And 1mmHG blood pressure doesn't portend anything whereas 20mmHG increase could double relative risk, but FDA said can't scrutinize 1mmHG as significant. Doc then said he feels challenged by the conclusion that none of this has an effect.
To address another investor debate around broadness of label (primary vs secondary): we want to clarify for the Street this is not a label for broad "primary" vs "secondary" patients but a request by AMRN for a labeled population that reflects a "high risk primary" population as well as obviously secondary prevention for pts with existing CV disease. The total could be at least 5-15M pts in the US. But even hitting just 1M pts on drug is a $2.5B drug in USA.
The "high-risk" primary population is a request for pts with high trigs, existing diabetes, and one other factor (one of many are listed out). We believe the label could reflect a "high-risk" primary population and we'll await final discussion by committee during the vote later today - but the secondary prevention is the vast majority of what is likely to be using Vascepa anyway, and frankly it's not clear that the exact wording of the label would even materially impact prescriptions, utilization, or reimbursement (and we note payor access even right now w/o a label has minimal restrictions, and it doesn't even have a formal CVOT label yet). So we think it's a good debate to have around wording of the label, but will not dramatically impact the stock either way or consensus numbers.
