Tuesday, March 31, 2020 6:12:02 AM
few points of feedback from our call. ..
? Insights into generic manufacturing capacity? Mgmt noted that there
are not that many companies who do omega-3 manufacturing and it is
not clear to AMRN who the generics are using for their supply. With the
ANDAs sitting with the FDA for some time now, we wonder whether
manufacturing could factor in to the lack of approvals thus far.
? Thoughts on appeal/path forward? Not surprisingly, Amarin intends
to appeal. Obviously whether any of the generics would launch at-risk
(once approved) while waiting for an appellate decision remains to be
seen. In the meantime, mgmt will continue to execute on their plan to
grow the market although they may not spend as much on DTC prior to
clarity on the appeal as they view this as a long-term investment.
Whether AMRN wins or loses on appeal, mgmt expects to ultimately be
able to run the company profitably and sees potential competitive
advantages in its manufacturing scale.
? What about Europe? Mgmt reiterated that this ruling does not change
things for Europe and they see potential for pricing in Europe that is at
least the same if not better than in the US since the price will be set on
the basis of the outcomes data. The company recently kicked off an EU
partnering process and will see what proposals come from that or
whether it makes more sense to go it alone in Europe.
Recent AMRN News
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