Label expansion in fiscal 2019
In a press release issued on January 4, Amarin (AMRN) announced that it will be submitting a supplemental new drug application (or sNDA) to the FDA in fiscal 2019, seeking inclusion of cardioprotective benefits as demonstrated in the REDUCE-IT trial in Vascepa’s label.
According to Amarin’s investor presentation, Vascepa is currently approved by the FDA to treat patients with triglyceride levels in excess of 500mg/dL. Results from the REDUCE-IT trial demonstrated Vascepa’s efficacy in reducing the cardiovascular risk for patients independent of their triglyceride levels.
According to the company’s investor presentation, Vascepa demonstrated 25% relative risk reduction (or RRR) in major adverse cardiovascular events (or MACE) and 20% RRR in cardiovascular death when administered to patients on top of statin therapy. Vascepa also demonstrated a 28% RRR drop in strokes and 31% RRR drop in heart attack on top of statin therapy. The company also plans to leverage data from the REDUCE-IT trial to secure regulatory approvals in ex-US markets.
Wall Street estimates
Wall Street analysts expect Amarin to report a non-GAAP loss per share of $0.37 in fiscal 2018, a YoY deterioration of 46.60%. The company is also expected to report a loss per share of $0.10 in fiscal 2019, a YoY improvement of 73.42%. Wall Street analysts have forecasted Amarin’s fiscal 2020 non-GAAP EPS to be $0.27, a YoY improvement of 376.80%.
Analysts have projected Amarin’s loss per share to be close to $0.08 in the fourth quarter of 2018, a YoY deterioration of 1.25%.
In the next article, we’ll discuss the cost structure of Amarin in greater detail.