On a GAAP basis, Amarin reported a net loss of $33.7 million, or $0.11 per share, compared to $22.5 million, or $0.08 per share in the prior-year period. Adjusted net loss was $28.9 million, or $0.09 per share.
Normalized prescriptions for Vascepa increased by 33% and 32% during the quarter compared to the year-ago period, based on data from Symphony Health and IQVIA, respectively. Estimated normalized Vascepa prescriptions totaled approx. 539,000 and 538,000, based on data from Symphony Health and IQVIA, respectively.
For the full year of 2019, net revenue is expected to increase by more than 50% versus 2018 to approx. $350 million, mostly from US sales of Vascepa.
The results from Amarin’s REDUCE-IT cardiovascular outcomes study of Vascepa demonstrated, compared to placebo, a 25% reduction in major adverse cardiovascular events, and a 20% reduction in cardiovascular death.
Drug application
Based on these results, Amarin intends to submit a supplemental new drug application (sNDA) to the US FDA seeking labeling for Vascepa, reflecting the cardiovascular risk reduction results demonstrated in this study. Amarin remains on track to submit this sNDA before the end of the first quarter of 2019 (i.e. before the end of March 2019) with a normal 10-month regulatory review period assumed prior to a PDUFA date.
Last week, Amarin’s stock jumped 14% after rumors emerged that Novartis (NVS) was interested in acquiring the company. A Novartis spokesperson told AlphaStreet that the company does not respond to rumors and market speculations.