-=Amarin (AMRN) reported earnings on Tue 5 Nov 19 (b/o)

Amarin beats by $0.03, beats on revs
Reports Q3 (Sep) loss of $0.01 per share, $0.03 better than the S&P Capital IQ Consensus of ($0.04); revenues rose 104.4% year/year to $112.4 mln vs the $110.04 mln S&P Capital IQ Consensus.

Amarin reiterates FY19 revenue; FDA advisory committee meeting pertaining to the sNDA for axpanded Vascepa approval is scheduled to be held on November 14, 2019

Amarin reiterates its net revenue guidance for 2019 of $380 million to $420 million. Amarin does not plan to issue quantified 2020 guidance until after it knows the details of the label for Vascepa following the PDUFA date.

December 28, 2019 is the Prescription Drug User Fee Act (PDUFA) target date for action on Amarin's supplemental New Drug Application (sNDA) seeking approval of Vascepa as the first drug approved for cardiovascular risk reduction in the patient population studied in REDUCE-IT. An FDA advisory committee meeting pertaining to the sNDA for Vascepa is scheduled to be held on November 14, 2019 at the FDA's offices in White Oak, Maryland. As is the usual protocol, briefing books will be used for preparation of advisory committee panel members with information related to Vascepa, the related science and questions that the advisory committee panel members will be asked to vote on at the meeting. The briefing books typically are made public two days before the commencement of the advisory committee meeting.