Revenue performance in fiscal 2018
In fiscal 2018, Amarin (AMRN) reported revenues of $229.2 million, a year-over-year rise of 27%, mainly driven by rising demand for Vascepa. In its fourth-quarter earnings press release, Amarin has reiterated its fiscal 2019 net revenue guidance of $350 million, a year-over-year rise greater than 50%. The company, however, has guided for quarterly revenue volatility in fiscal 2019.
According to the company’s fourth-quarter earnings press release, Amarin plans to submit a supplemental new drug application seeking label expansion for Vascepa based on the REDUCE-IT trial’s results by the end of the first quarter of 2019. Assuming a standard review period of ten months, the company expects an FDA decision by the end of 2019 or early 2020. So, according to the company’s fourth-quarter earnings press release, Vascepa’s anticipated label expansion isn’t expected to affect Amarin’s revenue in fiscal 2019.
Commercialization strategy in fiscal 2018
According to the company’s fourth-quarter earnings conference call, the results of the REDUCE-IT trial initiated the second phase of Amarin’s commercialization strategy for Vascepa in the US market.
In the first phase, which lasted until late 2018, the company mainly focused on promoting Vascepa in its approved label as adjunctive therapy for reducing triglyceride levels in hypertriglyceridemic patients. The company reached out to the target patient population by deploying a small sales team and working with co-promotion partner Kowa Pharmaceuticals.
Next in this series, we’ll discuss Amarin’s EPS in fiscal 2018.