Categories Earnings, Health Care

Amarin (AMRN) exploring use of VASCEPA in COVID-19-related cardiovascular risk reduction

Amarin hopes to receive approval for the launch of VASCEPA in Europe towards the end of this year

Shares of Amarin Corporation plc (NASDAQ: AMRN) were up 4.6% in midday trade on Tuesday, a day after the company reported preliminary results for the first quarter of 2020.

The stock has dropped 68% since the beginning of the year, taking a heavy hit in particular at the end of last month after losing its ANDA litigation over the launch of generic versions of its VASCEPA product. Amarin plans to appeal against this decision, the details of which we will come to shortly.  

Amarin reported preliminary total revenue of approx. $150 million for Q1 2020, up around 105% year-over-year, driven by increased prescription levels for VASCEPA. This number mainly reflects VASCEPA sales in the US and is likely to increase when international and licensing revenues are included.

The company also said at quarter-end, it had over $620 million in cash and cash equivalents and short-term investments, and less than $50 million due on its royalty-like debt instrument. The biopharma firm believes it is well-capitalized to achieve positive cash flows based on its current resources.

The company said the launch of VASCEPA in the US for a new cardiovascular risk reduction indication started off well in the first quarter, with the drug being the first and the only one for lowering cardiovascular risk beyond statin therapy. The growth in prescription levels exceeded the company’s expectations during the quarter.

Amarin believes there is a high medical need for VASCEPA and expects to see sales growth on a year-over-year basis despite the impact of the COVID-19 outbreak. The company also said it is reviewing opportunities for the use of VASCEPA in lowering cardiovascular risks related to COVID-19.

Amarin sees multi-billion dollar opportunities for VASCEPA outside the US. The company expects to report results from its clinical trial in China later this year through its partner in the region. The trial results are not expected to be impacted by the coronavirus outbreak and if successful, it could boost VASCEPA’s position in the country. 

The company is seeking a cardiovascular risk reduction indication for VASCEPA in Europe and is evaluating its options in terms of launching the product in the region either on its own or through partnerships. Amarin hopes to receive approval for its European launch towards the end of this year.

Amarin has faced setbacks in terms of the ANDA litigation and the ongoing COVID-19 crisis. With regards to the recent court ruling over the launch of the generic versions of VASCEPA, the company plans to appeal the decision and believes it has strong arguments on its side.

The company also added that even if the generic firms get FDA approvals for their ANDAs, it would be risky for them to launch during the appeal process as the possibility of Amarin winning the appeal and filing for significant damages remains open. Amarin also believes that the launch of generic versions of VASCEPA would reduce the potential of the product to benefit as many patients as possible.

Amarin said that the COVID-19 outbreak has presented it with both challenges and potential opportunities for VASCEPA usage. Although the company is seeing higher VASCEPA shipments and TRx levels versus a year ago, there appears to be a slowdown in new patient starts in recent weeks. Amarin also said the insurance coverage for VASCEPA improved at the start of April.

The company stated that it was too early to estimate the exact impact of the pandemic on its revenue levels and added that it would revisit its FY2020 revenue outlook after it is able to resume direct sales calls with physicians.

Amarin had planned to invest substantially in market development during 2020 but is now reducing its spending levels due to the patent litigation. The company will now prioritize its spending on activities that advance the growth of VASCEPA both in the US and internationally as well as on its efforts to succeed in the patent litigation.

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