Dive Brief:
- Amarin on Tuesday raised its 2019 revenue forecasts for its main drug Vascepa, disclosing another quarter of strong sales for the fish oil-derived pill as it continues to be boosted by results from a landmark heart study.
- The Ireland-based drugmaker now expects Vascepa revenue to fall between $380 million and $420 million this year, an increase from earlier guidance of $350 million. Sales for the second quarter came in at roughly $100 million, above Wall Street's consensus expectations.
- To further drive sales, Amarin plans to roughly double the size of its U.S. sales force over the next three months, which would bring the total to about 800 employees. The expansion will coincide with an expected decision from the Food and Drug Administration, set for September, on the drug's heart benefit.
Dive Insight:
While Amarin has not provided guidance on Vascepa (icosapent ethyl) beyond 2019, company executives have predicted the drug will bring in billions in revenue in the future.
Tuesday's boost to 2019 sales forecasts for the drug was expected, according to Stifel analyst Derek Archila, given "the general feeling that management's initial guidance was too conservative."
Even the new range may still be on the low side, Jefferies analyst Michael Yee wrote in a Tuesday note to investors. Yee noted a minor increase over first half sales, which totaled $172 million, would enable Amarin to reach the $380 million mark for the full year.
Rosy sales forecasts from analysts are dependent in large part on whether or not the FDA grants the expanded label Amarin seeks for Vascepa, based on the positive results of the REDUCE-IT study. That trial showed Vascepa significantly lowered cardiovascular risk for patients already on statin therapy.
Amarin said Tuesday it still does not know if the regulator will convene an advisory committee to discuss Vascepa's application, but that it anticipates the label expansion to be approved either way.
As it awaits the FDA's decision, the company is taking several steps to prepare, including doubling its sales force for the second time in the past 12 months.
In late 2018, following REDUCE-IT's readout, Amarin hired 265 sales reps, adding to the 170 employees on its sales team. Now, Amarin will hire and put in the field approximately 400 more representatives over the next three months.
Additionally, the company plans to launch an advertising campaign for Vascepa in the second quarter of 2020. Amarin said it will submit proposed ads to the FDA in October for regulatory review.
"We anticipate Vascepa revenue growth to accelerate further after label expansion approval and with a larger sales team, and then again after we commence promotion of Vascepa for cardiovascular risk reduction on television and through other media," Amarin CEO John Thero said in a Tuesday statement.
Amarin's stock opened Tuesday at $20.70, up 8%. The company's market value has grown nearly 700% since it released initial results of the REDUCE-IT study.