AMRN With their CC this morning:
Early takeaways from John Thero on earnings call: 1) No revenue guidance until company sees physicians' response to AHA results. 2) New 400-person sales force will target 50,000 physicians, double historic levels. 3) Potential market is "tens of millions of adults" at cardiac risk who cannot be addressed with statin-treatment alone. 4) Amarin already hearing requests from physicians for publication of Reduce-It results. 5) In active discussions with companies that can be added to the supply chain who "are eager to pursue this opportunity and competing with each other to do so." 6) Enlarged sales force to be trained and ready at start of 2019. Estimates Vascepa is where statin therapy was 30 years ago. 7) Likely to be a "multi-billion dollar brand."
EARNINGS TAKEAWAYS PART II: 1) Thero sounded confident about FDA expanded approval, noting the study was conducted under terms approved by the agency. "I'm sure given the results, the FDA will treat it appropriately." 2) Asked if supply will be a problem, Thero told analyst: "We are not capacity constrained. ... Expanding is very doable. It's just a matter of doing it." 3) Thero said another company sold a billion dollars annually of another product after proving a mere 6 percent risk reduction. Called 15 percent reductions "very meaningful." Then, he added, "anything above 15 percent was in the extraordinary category." 4) While saying he couldn't say anything about secondary endpoints prior to Nov. 10, he said: "People seeing the results will give them confidence in the meaning of that 25 percent." 5) Thero: "We're opening up an entirely new market here." 6) Another executive said there were "large potential opportunities throughout the world." However, direct sales force only exists in U.S., where Amarin says largest market exists. 7) U.S. sales force will concentrate on physicians who write the most statin prescriptions. 8) Physicians "seem surprised" at affordability of Vacepa. 9) General Counsel said lawsuits Monday were against two small dietary companies who tried to benefit from Reduce-It study. "The big players know well they can't cross the line under FDA regulations to compare themselves to drugs." 10) Thero said manufacturing Vacepa was difficult and called it a "fragile molecule. ... Not many companies in the world can do it. Those who can do it we have good relationships with."