Executive Summary / Key Takeaways

• Amarin is strategically pivoting its focus to global markets, particularly Europe with its extended IP protection through 2039, to drive future revenue growth and offset declining U.S. sales impacted by generic competition.
• VASCEPA/VAZKEPA, underpinned by the landmark REDUCE-IT trial demonstrating a 25% reduction in cardiovascular events, possesses a scientifically validated profile and is increasingly recognized in global medical guidelines, providing a strong foundation for international expansion.
• While U.S. product revenue continues to decline due to generic entry and loss of key PBM coverage, the U.S. business remains a significant source of cash generation, funding the company's international growth initiatives.
• European VAZKEPA sales are showing promising early growth (184% YoY in Q1 2025) driven by targeted strategies in key markets like Spain and the U.K., with further potential as pricing and reimbursement is secured in additional countries like Italy, Norway, and Ireland.
• Amarin maintains a solid financial position with $282.1 million in cash and investments and no debt as of March 31, 2025, supported by disciplined cost management and strategic supply chain adjustments, providing a runway of over one year to execute its global strategy.

The Pivot: From U.S. Dominance to Global Opportunity

Amarin Corporation plc, a pharmaceutical company with a history rooted in cardiovascular health, stands at a pivotal juncture. For years, its narrative was dominated by the U.S. market success of VASCEPA (icosapent ethyl), a unique omega-3 fatty acid product. Following its initial approval in 2012 for severe hypertriglyceridemia and, more significantly, the 2019 approval for cardiovascular risk reduction based on the groundbreaking REDUCE-IT trial, VASCEPA achieved blockbuster status. The REDUCE-IT data, demonstrating a remarkable 25% relative risk reduction in major adverse cardiovascular events in high-risk patients already on statin therapy, fundamentally reshaped the understanding of residual cardiovascular risk beyond LDL-C lowering alone. This scientific validation became the bedrock of VASCEPA's value proposition.

However, the U.S. landscape dramatically shifted following a 2020 court ruling that invalidated key patents covering the MARINE indication, paving the way for generic competition. This event fundamentally altered Amarin's U.S. trajectory, leading to significant pressure on branded VASCEPA's net selling price and volume. In response, Amarin has strategically pivoted, focusing on maximizing cash generation from the U.S. market tail while aggressively pursuing the substantial untapped potential of VASCEPA/VAZKEPA in international markets, particularly Europe.

Central to Amarin's strategy is its differentiated technology: highly purified icosapent ethyl (IPE). Unlike mixed omega-3 formulations, IPE is a single-molecule prescription product. The REDUCE-IT trial provided robust, quantifiable evidence of its clinical benefit, showing a 25% reduction in the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. This efficacy is attributed, in part, to IPE's pleiotropic effects beyond triglyceride lowering, including potential anti-inflammatory and antioxidant properties, and effects on lipoprotein(a) (Lp(a)), as explored in ongoing research and presentations at major medical conferences like the ACC. This scientific foundation has translated into significant medical advocacy, with over 50 global clinical guidelines and scientific statements recognizing the use of icosapent ethyl for cardiovascular risk reduction. This strong scientific backing and guideline support serve as a critical competitive moat, differentiating VASCEPA/VAZKEPA from less studied or less effective alternatives, including generic mixed omega-3s and even some other lipid-modifying therapies that have failed to show CV outcomes benefits in large trials.

Financial Performance: Navigating U.S. Declines with Global Growth

Amarin's recent financial performance reflects this strategic pivot and the dual reality of its markets. For the three months ended March 31, 2025, total revenue was $42.0 million, a 26% decrease from $56.5 million in the same period in 2024. This decline was primarily driven by a 26% decrease in U.S. net product revenue, falling from $48.1 million in Q1 2024 to $35.7 million in Q1 2025. The U.S. market continues to be impacted by generic competition and the loss of a large PBM account in the second half of 2024, which reduced branded VASCEPA volume. Amarin's branded share of the overall U.S. icosapent ethyl market decreased to approximately 42% in Q1 2025 from 56% in Q1 2024, while branded prescriptions saw a 24% decline year-over-year.

Despite these headwinds, management emphasizes that the U.S. business continues to generate significant cash, which is crucial for funding international expansion. The company is focused on efficiently extracting value from this mature market, maintaining exclusive access where possible, and is prepared to launch an authorized generic when strategically advantageous to maximize the product's lifecycle contribution.

The bright spot in the financial results is the accelerating growth in Europe. European net product revenue surged by 184%, from $1.9 million in Q1 2024 to $5.4 million in Q1 2025. This growth is attributed to the early stages of commercialization in launched markets, particularly Spain and the U.K., where a refined strategy focusing on high-risk patients with established cardiovascular disease is gaining traction. While still off a small base, this growth underscores the potential of the European market, especially with the critical extension of VAZKEPA's intellectual property protection out to 2039. This extended exclusivity provides a long runway for Amarin to capitalize on the estimated over six million eligible high-risk patients in Western Europe.

Revenue from Rest of World (RoW) partners was nominal ($0.018 million) in Q1 2025, a significant decrease from $5.2 million in Q1 2024. Management explained this variability is due to the timing of launch supply orders placed by partners, with a large order occurring in Q4 2024 to meet anticipated 2025 demand. RoW partnership revenue is expected to be variable quarter-to-quarter based on restocking cycles relative to in-market demand, but overall growth is anticipated as partners advance regulatory approvals and commercial launches in their respective territories. Licensing and royalty revenue, primarily from these partnerships, also saw a slight decrease, from $1.4 million in Q1 2024 to $1.0 million in Q1 2025, influenced by the timing of milestone achievements.

Cost of goods sold decreased by 31% in Q1 2025, outpacing the revenue decline, leading to an improvement in gross margin on product sales from 55% in Q1 2024 to 59% in Q1 2025. This margin improvement is primarily a result of a favorable change in customer mix. Operating expenses decreased by 8% year-over-year, reflecting the company's ongoing cost optimization initiatives, particularly in selling expenses, partially offset by increased general and administrative costs related to the ADS ratio change. The net result for Q1 2025 was a net loss of $15.7 million, compared to a net loss of $10.0 million in Q1 2024, reflecting the impact of the U.S. revenue decline despite cost controls and European growth.

Competitive Landscape and Strategic Positioning

Amarin operates in a highly competitive cardiovascular therapeutics market dominated by large pharmaceutical companies like AstraZeneca (AZN), Pfizer (PFE), and Amgen (AMGN), as well as facing direct competition from generic manufacturers and indirect competition from emerging therapies.

Compared to large players like AZN and PFE, which boast vast portfolios, extensive R&D capabilities, and global distribution networks resulting in higher gross margins (AZN ~81%, PFE ~74% TTM) and net margins (AZN ~13%, PFE ~13% TTM), Amarin is a niche player. Its TTM gross margin is lower (~35%), and it is currently operating at a net loss. These larger companies benefit from significant economies of scale in manufacturing and R&D, leading to lower operating costs per unit and faster innovation cycles in some areas.

Amarin's competitive edge lies in the specific, clinically proven benefits of IPE for cardiovascular risk reduction in a defined high-risk population, particularly its demonstrated efficacy beyond LDL-C lowering. While competitors offer broad lipid-lowering therapies (e.g., statins like AZN's Crestor, PFE's Lipitor, or PCSK9 inhibitors like AMGN's Repatha), VASCEPA is positioned as a complementary therapy addressing residual risk. The REDUCE-IT data provides a quantifiable performance advantage in this specific indication.

Against smaller competitors like Esperion Therapeutics (ESPR), which also focuses on lipid management with products like bempedoic acid, Amarin's VASCEPA has a longer history, broader guideline recognition, and the unique REDUCE-IT outcomes data. While ESPR's products may offer comparable efficacy in some lipid parameters or potentially lower costs, VASCEPA's proven CV outcomes benefit provides a significant differentiation. ESPR also currently operates at a net loss and has a higher debt-to-equity ratio (~-0.77 TTM) compared to Amarin's debt-free balance sheet.

The most direct and impactful competition in the U.S. comes from generic manufacturers (Hikma, Dr. Reddy's (RDY), Teva (TEVA), Apotex, etc.). These competitors offer chemically equivalent icosapent ethyl products, primarily targeting the severe hypertriglyceridemia indication (where patents were invalidated). Their ability to offer significantly lower prices directly erodes Amarin's branded U.S. revenue and net selling price. Amarin's strategy to counter this involves leveraging its remaining exclusive contracts, focusing on the REDUCE-IT indication where possible, and maintaining the option to launch an authorized generic to compete on price and maintain market share leadership in the overall IPE market.

In Europe and RoW, Amarin's strategy relies heavily on partnerships (Eddingpharm in China, CSL Seqirus in Australia, HLS (HLS.TO) in Canada, Biologix in MENA, Lotus (1795.TW) in ASEAN, Neopharm in Israel). This partnership model allows Amarin to leverage local expertise and infrastructure to navigate complex regulatory and reimbursement landscapes, a competitive necessity given its smaller scale compared to global giants. The extended European IP to 2039 is a critical asset, providing a period of market exclusivity that is absent in the U.S. and offers a significant competitive advantage against potential generic entry in Europe for the next 15 years.

Customer concentration (three major wholesalers accounted for 33%, 29%, and 29% of gross product sales in Q1 2025) and reliance on third-party manufacturers for its supply chain are operational dynamics that influence Amarin's competitive standing. While managing these relationships requires careful execution, the company has successfully diversified its supplier base and renegotiated supply agreements to align with current demand and conserve cash, mitigating some supply chain risks.

Liquidity, Outlook, and Risks

As of March 31, 2025, Amarin held $282.1 million in cash, cash equivalents, restricted cash, and short-term investments, with no outstanding debt. This solid liquidity position is a key strength, providing financial flexibility to execute its global strategy.

Net cash used in operating activities was $12.5 million in Q1 2025, consistent with the prior year period. The company has maintained cash burn below 10% over the last 10 quarters through disciplined cost management and strategic adjustments. Management believes its current cash and investments are sufficient to fund projected operations for at least one year from the filing date (May 7, 2025).

The outlook is centered on driving growth outside the U.S. Management anticipates continued year-over-year declines in U.S. revenue due to market dynamics but expects seasonal volume patterns. European growth is projected to continue as the company expands access and drives uptake in launched markets and secures pricing and reimbursement in additional key countries like Italy, Norway, and Ireland later in 2025. RoW revenue from partners is expected to be variable but contribute to overall growth as markets mature, with significant opportunities identified in China (pursuing NRDL listing for 2026) and Australia.

Key risks to this outlook include the ongoing impact of generic competition in the U.S., potential delays or unfavorable outcomes in European pricing and reimbursement negotiations, variability in RoW partner performance and restocking cycles, and dependence on third-party manufacturers. Litigation risks, including antitrust lawsuits from generic companies, a DOJ investigation, and ongoing patent infringement litigation against Hikma (currently pending Supreme Court review of a favorable Federal Circuit ruling), could result in significant costs, penalties, or damages, potentially impacting financial health and strategic focus. The company successfully addressed its NASDAQ listing compliance by implementing a 1-for-20 ADS ratio change effective April 11, 2025, and regaining compliance on April 29, 2025, removing an immediate delisting threat, though maintaining compliance requires the share price to remain above $1.00.

Amarin also has an approved share repurchase program of up to $50 million, valid until Q2 2029, but has not commenced repurchases, stating it is monitoring business and market conditions. This remains a potential avenue for returning value to shareholders if financial performance and market conditions improve.

Conclusion

Amarin's story is one of adaptation in the face of significant market disruption. The loss of U.S. patent exclusivity fundamentally changed its landscape, forcing a strategic pivot towards global markets. While the U.S. business faces continued headwinds from generic competition, it remains a vital cash engine. The core investment thesis now hinges on the successful execution of Amarin's global expansion strategy, particularly leveraging the extended European IP through 2039 and the scientific validation of VASCEPA/VAZKEPA to drive growth in Europe and through partnerships in the Rest of the World. Early signs from Europe are encouraging, with strong growth in launched markets and progress in securing reimbursement in new territories. The company's solid cash position and disciplined cost management provide the necessary foundation and runway to pursue these opportunities. Success will depend on effectively navigating the complex international pricing and reimbursement environment, managing partner performance, and mitigating ongoing litigation risks, ultimately aiming to translate the proven clinical value of icosapent ethyl into sustainable global revenue growth and unlock value for shareholders.