Amarin Corporation plc is a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health and reduce cardiovascular risk. The company's journey has been marked by both challenges and triumphs, as it navigates the complex and ever-evolving pharmaceutical landscape.
Business Overview and History
Amarin was originally incorporated in England as a private limited company in 1989 and re-registered as a public limited company in 1993. The company's primary focus has been on the development and commercialization of VASCEPA, a prescription-only omega-3 fatty acid product, which is sold under the brand names VASCEPA in the United States and VAZKEPA in Europe and other international markets.
VASCEPA was first approved by the U.S. Food and Drug Administration (FDA) in 2012 for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. The company commercially launched VASCEPA in the U.S. in 2013. In 2019, the FDA approved an additional indication and label expansion for VASCEPA based on the landmark results of the REDUCE-IT cardiovascular outcomes trial, making it the first and only drug approved by the FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high-risk patients.
On the international front, in 2021, the European Commission approved the marketing authorization application for VAZKEPA in the European Union, making it the first and only approved therapy to reduce cardiovascular risk in high-risk, statin-treated patients with elevated triglyceride levels. Amarin has continued to make progress in securing regulatory approvals and commercial launches for VASCEPA/VAZKEPA in various other markets around the world, including China, Canada, and the Middle East and North Africa region.
Amarin has faced significant challenges over the years, including patent litigation in the U.S. that led to the entry of generic versions of icosapent ethyl in 2020, which had an adverse impact on the company's U.S. business. In response, Amarin took steps to right-size its operations, including through an organizational restructuring plan implemented in 2023 that reduced its workforce by approximately 30%. The company has also worked to expand VASCEPA/VAZKEPA globally through partnerships in various international markets, including China, Canada, the Middle East, and Australia, among others.
Financial Overview
Financials
Amarin has reported total revenues of $228.6 million for the full year of 2024, with product revenue accounting for $204.6 million and licensing and royalty revenue contributing $24.0 million. The company's U.S. product revenue declined to $166.7 million in 2024, compared to $273.9 million in the prior year, primarily due to the impact of generic competition and a decrease in volume from a large national pharmacy benefit manager (PBM) moving VASCEPA from exclusive to non-covered status.
However, Amarin's international operations, including Europe and the rest of the world, have shown promising growth, with European product revenue increasing to $13.7 million in 2024 from $3.3 million in the prior year, and revenue from partnerships in other regions rising to $24.2 million from $8.1 million.
The company's gross margin on product sales was 28% in 2024, down from 50% in the prior year, due to the decline in U.S. net selling price and non-cash inventory restructuring charges.
For the full year 2024, Amarin reported a net loss of $82.2 million and negative operating cash flow of $31.0 million. The fourth quarter of 2024 saw revenue of $62.3 million and a net loss of $48.6 million. The decrease in Q4 revenue compared to the prior year quarter was due to a decline in U.S. product revenue, driven by lower net selling price as a result of generic competition and a decrease in volume primarily related to the loss of a large national payer. This was partially offset by increases in both European and Rest of World product revenue.
Amarin reduced its operating expenses by 26% year-over-year in 2024, meeting its commitment of a $50 million annual operating expense reduction made in 2023. Research and development expenses for 2024 were $20.9 million, down from $22.2 million in the prior year. The decrease was primarily due to lower costs associated with the REDUCE-IT study and presentations as well as reduced spending on a fixed-dose combination program.
Liquidity
Amarin has maintained a strong cash position, ending 2024 with $294.2 million in cash, cash equivalents, and short-term investments, with no debt. The company's debt-to-equity ratio stands at 0.02, while its current ratio is 3.31 and quick ratio is 2.39, indicating a strong liquidity position.
Navigating Challenges and Expanding Global Reach
Amarin has faced its share of challenges, including the loss of several patents covering the MARINE indication for VASCEPA in the U.S. in 2020, which led to the entry of generic versions of icosapent ethyl. The company has been subject to several antitrust lawsuits filed by generic companies and consumer groups, alleging anticompetitive practices related to the supply of VASCEPA API. These lawsuits are ongoing.
In response to these challenges, Amarin has pivoted its strategy, focusing on efficient cash management, operational streamlining, and the expansion of VASCEPA/VAZKEPA's global footprint. In July 2023, Amarin implemented an Organizational Restructuring Program that eliminated the company's entire U.S. sales force, with the managed care and trade organization continuing to support U.S. commercial efforts.
In the U.S., Amarin has maintained a resilient VASCEPA franchise, with the branded product continuing to generate significant cash despite the generic competition. The company has also implemented a plan to potentially launch an authorized generic version of VASCEPA when the time is optimal.
Internationally, Amarin has made substantial progress in securing regulatory approvals and commercial launches for VAZKEPA. The company has filed for regulatory review in 22 countries and regions and has received approval in 15 markets outside the U.S. and European Union, including in China, Switzerland, Australia, New Zealand, and Israel. As of the filing date, Amarin has received regulatory approval for VASCEPA under the REDUCE-IT indication in 49 countries, including the U.S. and 27 EU member states.
In Europe, Amarin has implemented a new commercial strategy focused on very high-risk patients with established cardiovascular disease. This approach has resulted in the company securing pricing and reimbursement in 10 European markets since 2023, including the UK, Spain, and Italy. The company's European revenues have gradually increased throughout 2024, driven by growth in these launch markets.
Amarin has also continued to strengthen its global partnerships, signing deals with companies like CSL Seqirus in Australia and New Zealand, Lotus Pharmaceuticals in Southeast Asia, and Neopharm in Israel to commercialize VAZKEPA in their respective territories.
Ongoing Research and Scientific Advancement
Amarin's commitment to research and development has been a key driver of its success. The company has supported more than 500 publications to advance the understanding of the science behind icosapent ethyl, the active ingredient in VASCEPA/VAZKEPA, and its potential mechanisms of action in reducing cardiovascular risk.
In 2024, Amarin and its global collaborators supported 45 publications, including peer-reviewed articles, abstracts, and presentations at major medical conferences. This extensive body of scientific evidence has helped to fuel the growing global medical advocacy for VASCEPA/VAZKEPA, with the product being recognized in more than 50 clinical guidelines, consensus statements, and scientific publications from leading medical societies around the world.
Amarin's research efforts have also led to the recent publication of a post-hoc analysis of the REDUCE-IT study in the Journal of the American Heart Association. This analysis showed that icosapent ethyl reduced the composite cardiovascular endpoint events, regardless of patients' baseline LDL-C levels, including among those with very well-controlled LDL-C below 55 mg/dL. These findings underscore the potential for VASCEPA/VAZKEPA to be an effective complementary therapy to widely used LDL-C lowering drugs in reducing the residual cardiovascular risk for high-risk patients.
Looking Ahead
As Amarin navigates the challenges posed by generic competition in the U.S. and continues to expand the global reach of VASCEPA/VAZKEPA, the company remains focused on several key priorities for 2025 and beyond:
1. Maintaining the critical NASDAQ listing by completing the announced 1-for-20 ADS ratio change. 2. Driving momentum in Europe and other international markets through continued pricing and reimbursement negotiations, commercial launches, and partnerships. 3. Efficiently managing U.S. operations to maximize profitability in the face of generic competition. 4. Advancing the scientific understanding of icosapent ethyl and its potential to address the significant unmet need in cardiovascular disease management globally. 5. Maintaining financial and operational discipline to support the company's long-term growth and value creation.
While Amarin did not provide specific financial guidance for 2025, the company expressed confidence in generating further momentum, building off the progress made in 2024. The cardiovascular disease treatment market is expected to grow at a CAGR of around 5-7% over the next 5 years, driven by the increasing prevalence of cardiovascular conditions globally and the development of novel therapies. VASCEPA addresses an important unmet need in this growing market.
In June 2024, the company's former CEO, Patrick Holt, voluntarily resigned. He was succeeded by Aaron Berg, the company's former Executive Vice President and President U.S.
Amarin's journey has not been without its obstacles, but the company's unwavering commitment to its product, scientific innovation, and global expansion has positioned it to capitalize on the tremendous opportunities ahead. As the company continues to navigate the complex and evolving pharmaceutical landscape, Amarin's focus on execution, strategic partnerships, and patient-centric innovation will be key to driving long-term success and shareholder value.