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AMARIN CORP PLC\UK (AMRN)

Business Summary

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 operates in one business segment. Its commercialized product, VASCEPA (icosapent ethyl), was first approved by the U.S. FDA in July 2012 for the MARINE indication and received a label expansion in December 2019 based on the REDUCE-IT trial. In Europe, the EC approved VAZKEPA in March 2021, and the MHRA approved it in England, Scotland, and Wales in April 2021. The company and its seven commercial partners are in various stages of seeking or maintaining regulatory approval, obtaining pricing and reimbursement, and commercialization globally.

In the U.S., Amarin faces competition from multiple generic versions of icosapent ethyl that have entered the market following the invalidation of several MARINE indication patents in 2020. Competitors include Hikma, Dr. Reddy's, Teva, Apotex, Zydus, Amneal, Epic Pharma, and Ascent Pharmaceuticals, among others. The company also competes with branded products like Lovaza, Tricor, Trilipix, and Niaspan, as well as their generic versions, and with dietary supplement manufacturers marketing omega-3 products. Outside the U.S., VASCEPA faces competition from large pharmaceutical companies and generic firms, though no other drug is approved for cardiovascular risk reduction in Europe for the REDUCE-IT studied population. The company's competitive advantages include the REDUCE-IT trial results demonstrating a 25% relative risk reduction in major adverse cardiovascular events, its EPA-only/DHA-free composition, and its U.S. FDA-approved prescription-only status.

Amarin generates revenue primarily through product sales of VASCEPA in 1-gram and 0.5-gram capsules. In the U.S., VASCEPA is sold principally to a limited number of major wholesalers, regional wholesalers, and retail and mail order pharmacy providers. Outside the U.S., product revenue is derived from sales to commercial partners who then resell the product in their territories. The company also earns licensing and royalty revenue from upfront payments, milestone payments, and sales-based payments related to license and distribution agreements for VASCEPA outside the U.S. The company is responsible for supplying VASCEPA to all markets where the branded product is sold.

VASCEPA is the company's sole commercialized product, approved for two indications in the U.S.: the MARINE indication for reducing triglyceride levels in patients with severe hypertriglyceridemia (≥500 mg/dL), and the REDUCE-IT indication as an adjunct to maximally tolerated statin therapy for reducing cardiovascular risk in select high-risk patients. In Europe, VAZKEPA is approved to reduce the risk of cardiovascular events in high-risk statin-treated adult patients with elevated triglycerides (>150 mg/dL) and either established cardiovascular disease or diabetes with at least one additional risk factor. The company also has partnerships for commercialization in Canada (HLS Therapeutics), Australia and New Zealand (CSL Seqirus), the Middle East and North Africa (Biologix), China (Edding), Southeast Asia (Lotus), and Israel (Neopharm). In June 2025, the company entered into an exclusive long-term license and supply agreement with Recordati for the development and commercialization of VAZKEPA in 59 countries focused in Europe.

On June 24, 2025, the company announced a global restructuring plan in connection with the execution of the Recordati Licensing Agreement, with the vast majority of estimated cost savings to come from the elimination of commercial roles in its European operations. The company expects these actions will reduce operating costs by approximately $70 million annually. On January 10, 2024, the company announced plans to initiate a share repurchase program to purchase up to $50.0 million of the company's ordinary shares held in the form of ADSs, though no repurchases have been commenced to date. The company also implemented an ADS ratio change effective April 11, 2025, adjusting from one ADS representing one ordinary share to one ADS representing 20 ordinary shares.

For the fiscal year ended December 31, 2025, total revenue, net was $213.6 million , compared to $228.6 million in 2024, a decrease of $15.0 million or 7%. Product revenue, net was $182.8 million in 2025 versus $204.6 million in 2024, a decrease of $21.8 million or 11%. The company reported a net loss of $38.8 million for 2025, compared to a net loss of $82.2 million in 2024. As of December 31, 2025, the company had cash and cash equivalents of $134.7 million and short-term investments of $167.9 million , aggregating $302.6 million , with no indebtedness.

Business Outlook & Financial Sufficiency

The company has suspended providing net revenue guidance due to the impact from U.S. generic competition, as there could be significant differences between estimates and actual product demand.

A key growth vector is the commercialization of VAZKEPA in Europe through the Recordati Licensing Agreement, which covers 59 countries. Recordati is solely responsible for commercializing VAZKEPA in the Recordati Territory and will use commercially reasonable efforts to pursue future product reimbursements and approvals. The company will be eligible to receive sales-based milestone payments totaling up to $150.0 million and royalties on net sales. Another growth vector is the continued expansion through partnerships in the rest of the world, including with Edding in China, Biologix in the MENA region, HLS in Canada, CSL in Australia and New Zealand, Lotus in Southeast Asia, and Neopharm in Israel. The company has filed for regulatory review in 22 countries and regions and has received approval in 17 countries and regions outside the U.S. and EMA regulatory approval authority.

The company expects the Global Restructuring Plan announced in June 2025 will reduce operating costs by approximately $70 million annually, with the vast majority of savings from the elimination of commercial roles in European operations. Cost of goods sold decreased by $54.5 million or 37% in 2025 compared to 2024, partly due to a $36.5 million restructuring inventory charge recorded in 2024. Selling, general and administrative expense decreased by $37.3 million or 24% in 2025 versus 2024, primarily due to the restructuring and other cost optimization initiatives.

As of December 31, 2025, the company had inventory of $195.9 million , of which approximately 50% is inventory approved for use in North America. The company continues to negotiate with contract suppliers to align supply arrangements with current and future global market demand. The company manages manufacturing and supply through contract manufacturers and has multiple U.S. FDA-approved international API suppliers, encapsulators, and packagers. The company had approximately 80 full-time employees as of December 31, 2025 , located in six countries, with 60% in the U.S. and 40% in Europe.

Research and development expense was $19.8 million in 2025, compared to $20.9 million in 2024. The company has no indebtedness. The share repurchase program authorized up to $50.0 million of the company's ordinary shares held in the form of ADSs, though no repurchases have been commenced. The company does not anticipate paying any cash dividends on ordinary shares in the foreseeable future.

The company faces significant headwinds from generic competition in the U.S., where multiple generic versions of icosapent ethyl have entered the market since November 2020. The company's share of the icosapent ethyl market decreased to approximately 47% in the year ended December 31, 2025 from approximately 53% in the year ended December 31, 2024. VASCEPA-branded prescriptions decreased by 10% in 2025 compared to 2024. The company also faces risks related to securing favorable product pricing and reimbursement levels outside the U.S., which vary by country and can take six to 12 months or longer after regulatory approval. Additionally, the company is subject to ongoing litigation, including antitrust lawsuits filed by generic competitors Dr. Reddy's, Hikma, Teva, and Apotex, as well as civil investigative demands from the U.S. Federal Trade Commission and a subpoena from the New York Attorney General.

Management Sentiments & Priorities

Management's message emphasizes the strategic transformation of the company through the Recordati Licensing Agreement and Global Restructuring Plan, which are expected to reduce operating costs by approximately $70 million annually. The company is focused on continuing to generate revenue from partnerships in key international markets outside the Recordati Territory and on defending its intellectual property rights. Management has suspended providing net revenue guidance due to the impact from U.S. generic competition. Key strategic priorities include executing the Recordati partnership to maximize the value of VAZKEPA in Europe, managing the U.S. business in the face of generic competition, and pursuing regulatory approvals and commercialization in rest of world markets through existing and potential new partnerships.

Financial Details

For the fiscal year ended December 31, 2025, total revenue, net was $213.6 million compared to $228.6 million in 2024. Product revenue, net was $182.8 million in 2025 versus $204.6 million in 2024. U.S. product revenue, net was $154.1 million in 2025 compared to $166.7 million in 2024. Licensing and royalty revenue was $30.9 million in 2025 versus $24.0 million in 2024, an increase of $6.9 million or 29%, primarily due to a $25.0 million upfront payment from the Recordati Licensing Agreement. Cost of goods sold was $92.8 million in 2025 compared to $147.2 million in 2024, a decrease of $54.5 million or 37%, including a $36.5 million restructuring inventory charge in 2024. Overall gross margin on product sales was 49% in 2025 and 28% in 2024; excluding restructuring inventory and inventory write-off charges, gross margin was 49% and 50% for 2025 and 2024, respectively. Selling, general and administrative expense was $115.0 million in 2025 versus $152.3 million in 2024. Research and development expense was $19.8 million in 2025 versus $20.9 million in 2024. Restructuring expense was $36.2 million in 2025 compared to nil in 2024, due to the Global Restructuring Plan. Interest income, net was $10.8 million in 2025 versus $13.4 million in 2024. Other income, net was $3.3 million in 2025 versus $1.2 million in 2024. Provision for income taxes was $2.8 million in 2025 versus $5.0 million in 2024. Net loss was $38.8 million in 2025 compared to $82.2 million in 2024. As of December 31, 2025, cash and cash equivalents were $134.7 million , short-term investments were $167.9 million , and the company had no indebtedness. The company had an accumulated deficit of $1.7 billion as of December 31, 2025.

Risk Factors

The company is substantially dependent on VASCEPA, and its revenues and results of operations have been materially and adversely affected by generic competition in the U.S., where multiple generic versions of icosapent ethyl have entered the market since November 2020. The company's share of the icosapent ethyl market decreased to approximately 47% in 2025 from approximately 53% in 2024. Outside the U.S., the company faces risks related to securing favorable product pricing and reimbursement levels, which vary by country and can take six to 12 months or longer after regulatory approval. The company is also subject to ongoing antitrust litigation from generic competitors Dr. Reddy's, Hikma, Teva, and Apotex, as well as civil investigative demands from the U.S. Federal Trade Commission and a subpoena from the New York Attorney General. Additionally, the company's supply chain relies on third-party manufacturers, and as of December 31, 2025, the company had inventory of $195.9 million , of which approximately 50% is approved for use in North America, exposing the company to potential inventory write-downs if demand does not materialize.

References

  1. [1] Item 7, MD&A — Total Revenue, Net
  2. [2] Item 7, MD&A — Total Revenue, Net
  3. [3] Item 7, MD&A — Total Revenue, Net
  4. [4] Item 7, MD&A — Product Revenue, Net
  5. [5] Item 7, MD&A — Product Revenue, Net
  6. [6] Item 7, MD&A — Product Revenue, Net
  7. [7] Item 7, MD&A — Results of Operations
  8. [8] Item 7, MD&A — Results of Operations
  9. [9] Item 7, MD&A — Liquidity and Capital Resources
  10. [10] Item 7, MD&A — Liquidity and Capital Resources
  11. [11] Item 7, MD&A — Liquidity and Capital Resources
  12. [12] Item 1, Business — Rest of World
  13. [13] Item 1, Business — Global Restructuring Program
  14. [14] Item 7, MD&A — Cost of Goods Sold
  15. [15] Item 7, MD&A — Cost of Goods Sold
  16. [16] Item 7, MD&A — Selling, General and Administrative Expense
  17. [17] Item 7, MD&A — Commercial and Clinical Supply
  18. [18] Item 1, Business — Human Capital Management
  19. [19] Item 7, MD&A — Research and Development Expense
  20. [20] Item 7, MD&A — Research and Development Expense
  21. [21] Item 5, Market for Registrant's Common Equity — Share Repurchase Program
  22. [22] Item 7, MD&A — Product Revenue, Net
  23. [23] Item 7, MD&A — Product Revenue, Net
  24. [24] Item 7, MD&A — Product Revenue, Net
  25. [25] Item 7, MD&A — Product Revenue, Net
  26. [26] Item 7, MD&A — Product Revenue, Net
  27. [27] Item 7, MD&A — Commercial and Clinical Supply
  28. [28] Item 1, Business — Global Restructuring Program
  29. [29] Item 7, MD&A — Total Revenue, Net
  30. [30] Item 7, MD&A — Total Revenue, Net
  31. [31] Item 7, MD&A — Product Revenue, Net
  32. [32] Item 7, MD&A — Product Revenue, Net
  33. [33] Item 7, MD&A — Product Revenue, Net
  34. [34] Item 7, MD&A — Product Revenue, Net
  35. [35] Item 7, MD&A — Licensing and Royalty Revenue
  36. [36] Item 7, MD&A — Licensing and Royalty Revenue
  37. [37] Item 7, MD&A — Licensing and Royalty Revenue
  38. [38] Item 7, MD&A — Licensing and Royalty Revenue
  39. [39] Item 7, MD&A — Cost of Goods Sold
  40. [40] Item 7, MD&A — Cost of Goods Sold
  41. [41] Item 7, MD&A — Cost of Goods Sold
  42. [42] Item 7, MD&A — Cost of Goods Sold
  43. [43] Item 7, MD&A — Cost of Goods Sold
  44. [44] Item 7, MD&A — Cost of Goods Sold
  45. [45] Item 7, MD&A — Cost of Goods Sold
  46. [46] Item 7, MD&A — Cost of Goods Sold
  47. [47] Item 7, MD&A — Selling, General and Administrative Expense
  48. [48] Item 7, MD&A — Selling, General and Administrative Expense
  49. [49] Item 7, MD&A — Research and Development Expense
  50. [50] Item 7, MD&A — Research and Development Expense
  51. [51] Item 7, MD&A — Restructuring Expense
  52. [52] Item 7, MD&A — Interest Income, Net
  53. [53] Item 7, MD&A — Interest Income, Net
  54. [54] Item 7, MD&A — Other Income, Net
  55. [55] Item 7, MD&A — Other Income, Net
  56. [56] Item 7, MD&A — Provision for Income Taxes
  57. [57] Item 7, MD&A — Provision for Income Taxes
  58. [58] Item 7, MD&A — Results of Operations
  59. [59] Item 7, MD&A — Results of Operations
  60. [60] Item 7, MD&A — Liquidity and Capital Resources
  61. [61] Item 7, MD&A — Liquidity and Capital Resources
  62. [62] Item 7, MD&A — Liquidity and Capital Resources

Analysis on 6/21/2026