DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 02, 2023 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced financial results for the quarter ended June 30, 2023 and provided an update on company operations.
“I am honored to have joined Amarin and to lead the Company at this time,” said Patrick Holt, President & CEO of Amarin. Mr. Holt continued, “Amarin’s second quarter performance was marked by continued revenue generation in the U.S. and a cash positive quarter. While it is early in my tenure as President and CEO, it is clear to me the decisive and deliberate actions taken put us on the right path for the future. Those actions are now underway, and we are focused on managing our U.S. business to enhance profitability, redesigning our commercial infrastructure in Europe to better align with current and future commercial potential, and working to generate revenue from partnerships in key international markets. We believe these steps will place us on the right path to support continued efforts to bring VASCEPA/VAZKEPA to patients globally while enhancing value for shareholders.”
“We remain steadfast in our conviction on the depth and breadth of our clinical data for VASCEPA/VAZKEPA based on REDUCE-IT®, the definitive, large, long-term outcomes study of icosapent ethyl with gold standard cardiovascular clinical endpoints. Further, we remain committed to maximizing the value of VASCEPA/VAZKEPA and its impact for patients,” Holt concluded.
Europe
Amarin has early launches of VAZKEPA underway in several European countries, including the U.K. (England & Wales). In addition to these launch activities, the team in Europe is continuing to advance various Health Technology Assessment (HTA) processes and pricing & reimbursement discussions in all markets where Amarin has submitted market access dossiers. In July 2023, Amarin announced that the Spanish Drug Pricing Committee recommended the national reimbursement of VAZKEPA® (icosapent ethyl) to reduce the risk of cardiovascular (CV) events in patients with high cardiovascular risk.
United States
U.S. product net revenue was $64.6 million in the second quarter of 2023, a decline of $17.7 million versus the first quarter of 2023, a decrease of 22% sequentially. The Company maintains approximately 57% market share of IPE prescriptions despite generic competition as the U.S. commercial organization continues an efficient support of branded VASCEPA.
During the second quarter of 2023, Amarin maintained its existing access for VASCEPA in exclusive accounts, representing approximately 45% of all Commercial and Part D lives on a weighted average basis.
The U.S. business continues to support investments in Europe. Amarin continues to actively monitor key performance indicators in the U.S. market to support its strategy moving forward.
International
Amarin is in the process of filing regulatory submissions for approval in 20 additional countries to ensure that patients in these markets can benefit from VASCEPA/VAZKEPA. In the second quarter of 2023, Amarin secured regulatory approval for VASCEPA in China and the Kingdom of Saudi Arabia. Amarin is continuing to explore additional partnership opportunities in key markets around the world.
Financial Update
Total net revenue for the three months ended June 30, 2023, was $80.2 million, compared to $94.4 million in the corresponding period of 2022, a decrease of 15%. Total net revenue in the quarter includes $65.2 million in net product revenue and approximately $15.0 million in licensing and royalty revenue.
Net product revenue for the three months ended June 30, 2023, was $65.2 million, compared to $93.8 million in the corresponding period of 2022, a decrease of 31%. This decrease was driven by generic competition resulting in lower volume, as well as increased net pricing pressure in the U.S., versus the second quarter of 2022. In Europe revenue was $0.6 million in the second quarter of 2023.
Amarin recognized licensing and royalty revenue of $15.0 million, which includes $11.1 million of non-cash payment related to previously received partnership milestones and receipt of a cash milestone payment received in the quarter related to the VHTG regulatory approval in China. The majority of the $11.1 million non-cash payment is the result of a change in accounting estimate arising from a change in the performance period to complete the performance obligations, which led to an acceleration of revenue recognition.
Cost of goods sold for the three months ended June 30, 2023, was $37.5 million, compared to $50.8 million in the corresponding period of 2022. Amarin’s overall gross margin on net product revenue for the three months ended June 30, 2023 was 42%, compared with 46% for the corresponding period of 2022. During the three months ended June 30, 2023, Amarin amended a supplier agreement resulting in a charge of $14.3 million. During the three months ended June 30, 2022, Amarin also amended a supplier agreement resulting in a charge of $15.0 million and had a charge of $9.6 million related to unsellable inventory not related to product dating. Excluding the impact of these one-time items, gross margin was 64% and 72% for the three months ended June 30, 2023 and 2022, respectively.
Selling, general and administrative expenses for the three months ended June 30, 2023, was $51.0 million, compared to $86.9 million in the corresponding period of the prior year. This decrease was primarily due to the implementation of our previously announced cost reduction plan and commercial withdrawal from Germany.
Research and development expenses for the three months ended June 30, 2023, were $5.6 million, compared to $9.4 million in the corresponding period of the prior year. This decrease was primarily driven by the implementation of our previously announced cost reduction plan.
Restructuring expense for the three months ended June 30, 2023 was $10.0 million compared to $10.2 million in the corresponding period of the prior year. The charge in the current year is due to the implementation of the Organizational Restructuring Plan which was approved during the second quarter 2023 and announced on July 18, 2023, which resulted in a reduction of our entire U.S. sales field force, while maintaining our managed care and trade organization to support U.S. commercial efforts, as well as a reduction of approximately 30% of non-sales positions. The prior year charge was the result of the implementation of the Comprehensive Cost Reduction Plan announced on June 6, 2022, which primarily related to the reduction of our U.S. field force from approximately 300 sales representatives to approximately 75 sales representatives.
Under U.S. GAAP, Amarin reported a net loss of $17.6 million for the three months ended June 30, 2023, or basic and diluted loss per share of $0.04. For the three months ended June 30, 2022, Amarin reported a net loss of $70.0 million, or basic and diluted loss per share of $0.18. Non-GAAP adjusted net income was $8.6 million for the second quarter ended June 30, 2023, or non-GAAP adjusted basic and diluted earnings per share of $0.02, compared with non-GAAP adjusted net loss of $35.6 million for the three months ended June 30, 2022, or non-GAAP adjusted basic and diluted loss per share of $0.09. As of June 30, 2023, Amarin reported aggregate cash and investments of $313 million.
2023 Financial Outlook
Amarin continues to make progress on reducing operating expenses and managing its cash position. The Company is now lowering operating expense guidance for the full year 2023 to the range of $240 million to $250 million from $270 million to $285 million, reflecting additional identified cost savings along with timing of reimbursements as well as savings from restructuring. With the recent cash preservation initiatives, Amarin reiterates its belief that current cash and investments and other assets are adequate to support continued operations, including European launch activities.
About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.
