Amarin (NASDAQ: AMRN) narrows Q1 2026 loss as revenue grows modestly
Rhea-AI Filing Summary
Amarin Corporation reported a Q1 2026 net loss of $10.5 million, improving from $15.7 million a year earlier, as revenue edged up and operating costs fell. Total revenue reached $45.1 million, including $43.3 million of product sales and $1.8 million of licensing and royalty income.
Gross margin declined as cost of goods sold rose to $27.4 million, but selling, general and administrative expenses dropped sharply to $21.1 million, partly reflecting restructuring. The company recorded $3.3 million of restructuring expense and $3.1 million of litigation settlements. Amarin ended the quarter with $307.8 million in cash and short‑term investments, total assets of $645.8 million, and no debt, while generating $6.4 million of cash from operating activities.
Positive
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Negative
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Insights
Amarin narrowed losses in Q1 2026 while funding restructuring and litigation costs.
Amarin generated total revenue of $45.1 million in Q1 2026, modestly above the prior year, with U.S. product revenue of $35.6 million and rest-of-world contributions, plus $1.8 million from licensing and royalties. Cost of goods sold rose to $27.4 million, compressing gross margin.
Operating expenses fell to $29.1 million from $41.9 million, helped by lower selling and payroll costs, but included $3.3 million of Global Restructuring Plan charges and $3.1 million in litigation settlements within general and administrative expense. Net loss improved to $10.5 million, supported by $2.4 million of interest income.
Liquidity remains a key strength: cash and cash equivalents were $131.1 million, with short‑term investments of $176.8 million and no debt as of March 31, 2026. Operating activities provided $6.4 million of cash, aided by working capital releases from inventory and receivables. Future results will continue to reflect restructuring completion, supply commitments, and outcomes of ongoing legal proceedings described in the notes.
Key Figures
Key Terms
REDUCE-IT medical
Global Restructuring Plan financial
Topic 606 financial
going concern financial
fair value hierarchy financial
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
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Amarin Corporation plc |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
INDEX TO FORM 10-Q
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PART I – Financial Information |
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Item 1. |
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Financial Statements (unaudited): |
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Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025 |
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Condensed Consolidated Statements of Operations for the three months ended March 31, 2026 and 2025 |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Controls and Procedures |
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PART II – Other Information |
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Risk Factors |
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SIGNATURES |
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PART I
AMARIN CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in thousands, except share amounts)
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March 31, 2026 |
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December 31, 2025 |
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ASSETS |
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Current Assets: |
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Restricted cash |
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Short-term investments |
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Inventory |
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Prepaid and other current assets |
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Total current assets |
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Operating lease right-of-use asset |
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Other long-term assets |
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Intangible asset, net |
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TOTAL ASSETS |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current Liabilities: |
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Accounts payable |
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Accrued expenses and other current liabilities |
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Total current liabilities |
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Long-Term Liabilities: |
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Long-term operating lease liability |
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Other long-term liabilities |
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Total liabilities |
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Stockholders’ Equity: |
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Ordinary Shares, £ |
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Additional paid-in capital |
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Treasury stock; |
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Accumulated deficit |
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Total stockholders’ equity |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
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$ |
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See notes to condensed consolidated financial statements.
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AMARIN CORPORATION PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per share amounts)
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Three months ended March 31, |
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2026 |
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2025 |
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Product revenue, net |
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Licensing and royalty revenue |
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Total revenue, net |
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Less: Cost of goods sold |
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Gross margin |
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Operating expenses: |
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Selling, general and administrative |
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Research and development |
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Restructuring |
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— |
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Total operating expenses |
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Operating loss |
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Interest income, net |
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Other income, net |
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Loss from operations before taxes |
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Provision for income taxes |
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Net loss |
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Loss per Ordinary Share: |
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Basic |
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Diluted |
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Weighted average Ordinary Shares: |
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Diluted |
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See notes to condensed consolidated financial statements.
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AMARIN CORPORATION PLC
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited, in thousands, except share amounts)
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Ordinary |
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Treasury |
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Additional |
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Accumulated |
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Total |
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December 31, 2025 |
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Stock-based compensation |
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Loss for the period |
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March 31, 2026 |
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$ |
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$ |
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Ordinary |
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Treasury |
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Ordinary |
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Additional |
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Treasury |
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Accumulated |
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Total |
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December 31, 2024 |
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$ |
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$ |
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Vesting of restricted stock units |
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Stock-based compensation |
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Loss for the period |
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— |
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— |
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— |
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— |
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March 31, 2025 |
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$ |
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$ |
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$ |
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$ |
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See notes to condensed consolidated financial statements.
5
AMARIN CORPORATION PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in thousands)
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Three months ended March 31, |
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2026 |
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2025 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss |
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$ |
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$ |
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Adjustments to reconcile loss to net cash used in operating activities: |
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Depreciation and amortization |
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Accretion of investments |
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Stock-based compensation |
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Amortization of intangible asset |
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Changes in assets and liabilities: |
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Accounts receivable, net |
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Inventory |
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Prepaid and other current assets |
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Other long-term assets |
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Interest receivable |
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Accounts payable and other current liabilities |
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Other long-term liabilities |
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Net cash provided by (used in) operating activities |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Maturities of securities |
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Purchases of securities |
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Net cash (used in) provided by investing activities |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Taxes paid related to stock-based awards |
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Net cash used in financing activities |
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NET DECREASE IN CASH AND CASH EQUIVALENTS AND |
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CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD |
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CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD |
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$ |
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$ |
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Supplemental disclosure of cash flow information: |
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Cash paid during the year for: |
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Income taxes |
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$ |
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$ |
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Supplemental disclosure of non-cash transactions: |
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Initial recognition of operating lease right-of-use asset |
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$ |
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$ |
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See notes to condensed consolidated financial statements.
6
AMARIN CORPORATION PLC
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(1) Nature of Business and Basis of Presentation
Nature of Business
Amarin Corporation plc, or Amarin, or the Company, is a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk. The Company is commercialized in the United States, or the U.S., under the brand name VASCEPA® (icosapent ethyl). VASCEPA, under the brand name VAZKEPA, hereinafter along with VASCEPA, collectively referred to as VASCEPA is also commercialized in various other countries throughout the world.
The Company and seven commercial partners are in various stages: seeking or maintaining regulatory approval, obtaining government or private pricing and reimbursement, and/or commercialization. VASCEPA and VAZKEPA approvals and applications for approval globally reference either the U.S. New Drug Application, or NDA, core dossier or the European Medicines Agency, or EMA, core dossier.
VASCEPA (U.S. NDA Core Dossier) |
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VAZKEPA (EMA Core Dossier) |
Amarin (US) |
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Recordati Industria Chimica e Farmaceutica S.p.A "Recordati" (Europe) (1) |
HLS Therapeutics Inc. "HLS" (Canada) |
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CSL Seqirus "CSL"(Australia/New Zealand) |
Biologix FZCo "Biologix" (Middle East North Africa, or MENA) |
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Lotus Pharmaceuticals, "Lotus" (Southeast Asia) |
Eddingpharm (Asia) Macao Commercial Offshore Limited "Edding" (China Territory) |
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Neopharm (Israel) 1996 Ltd. "Neopharm" (Israel) |
(1) As part of the Recordati partnership, agreements with Vianex S.A "Vianex" (Greece), Magnapharm Marketing & Sales Romania S.R.L. "Magnapharm" (Romania), and Salus, Veletrgovina, d.o.o, "Salus" (Slovenia) will be transitioned to Recordati.
VASCEPA was first approved by the U.S. Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia, or the MARINE indication. In January 2013, the Company launched 1-gram size VASCEPA in the U.S. and in October 2016, introduced a 0.5-gram capsule size. On December 13, 2019, the U.S. FDA approved another indication and label expansion for VASCEPA based on the results of the Company’s long-term CV outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent CV risk in select high risk patients, or the REDUCE-IT indication.
On March 30, 2020, following conclusion of a trial in late January 2020, the U.S. District Court for the District of Nevada, or the Nevada Court, issued a ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, collectively, the Defendants, that declared as invalid several of the Company's patents covering the MARINE indication. The Company sought appeals of the Nevada Court judgment up to the U.S. Supreme Court, but the Company was unsuccessful. As a result, the following generic versions of icosapent ethyl have obtained U.S. FDA approval with labeling consistent with the MARINE indication of VASCEPA and have entered the U.S. market:
7
Company (ANDA Holder) |
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Distributed / Licensee |
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FDA MARINE Indication Approval |
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1-gram Launch Date |
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0.5-gram Launch Date |
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Active |
Hikma Pharmaceuticals USA Inc. |
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Hikma Pharmaceuticals USA Inc.; |
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May 2020 |
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November 2020 |
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March 2023 |
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Yes |
Dr. Reddy’s Laboratories, Inc. |
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Dr. Reddy’s Laboratories, Inc. |
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August 2020 |
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June 2021 |
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June 2023 |
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Yes |
Teva Pharmaceuticals USA, Inc. |
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Teva Pharmaceuticals USA, Inc.; |
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September 2020 |
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January 2023 |
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September 2022 |
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Yes |
Apotex, Inc. |
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Apotex, Inc.; |
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June 2021 |
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January 2022 |
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– |
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Yes |
Zydus Lifesciences |
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Zydus Pharmaceuticals USA |
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April 2023 |
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August 2024 |
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June 2024 |
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Yes |
Onesource Specialty (Amneal Original Filer) |
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Amneal Pharmaceuticals |
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September 2023 |
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April 2024 |
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April 2024 |
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Yes |
Humanwell Puracap |
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Epic Pharma |
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December 2023 |
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March 2024 |
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– |
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Yes |
Ascent Pharmaceuticals, Inc. |
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Camber Pharmaceuticals; |
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December 2023 |
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April 2024 |
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April 2024 |
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Yes |
Qilu Pharmaceutical Co Ltd |
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– |
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November 2024 |
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– |
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– |
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No |
PharmaObedient (Spriaso Original Filer) |
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– |
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December 2024 |
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– |
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– |
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No |
Xiamen LP Pharma Co. |
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Vitruvias Therapeutics |
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August 2025 |
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January 2026 |
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– |
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Yes |
On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VAZKEPA, in the European Union, or EU, to reduce the risk of CV events in high-risk, statin-treated adult patients who have elevated TGs (>150 mg/dL) and either established CV disease or diabetes and at least one additional CV risk event. On April 22, 2021, the Company announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce CV risk. Collectively, CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.
On June 24, 2025, the Company announced the execution of an exclusive long-term license and supply agreement with Recordati Industria Chimica e Farmaceutica S.p.A., or Recordati, to develop and commercialize VAZKEPA in
On June 1, 2023, the Company announced that the National Medical Products Administration, or NMPA, granted approval for VASCEPA under the MARINE indication and the Company's partner, Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, launched commercially in October 2023. On June 28, 2024, Edding received NMPA approval for VASCEPA in Mainland China for the REDUCE-IT indication. On February 23, 2022, the Hong Kong Department of Health concluded their evaluation and approved the use of VASCEPA under the REDUCE-IT indication.
Amarin is responsible for supplying VASCEPA to all markets in which the branded product is sold, including countries where the drug is promoted and sold via collaboration with third-party partners that compensate Amarin for such supply. Amarin is not responsible for providing any generic company with drug product.
Basis of Presentation
The condensed consolidated financial statements included herein have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles, or GAAP, and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. Certain information in the footnote disclosures of the financial statements has been condensed or omitted where it substantially duplicates information provided in the Company’s latest audited consolidated financial statements, in accordance with the rules and regulations of the SEC. These condensed consolidated financial statements should be read in
8
conjunction with the Company’s audited consolidated financial statements and notes included in its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, or the Form 10-K, filed with the SEC. The balance sheet amounts in this report were derived from the Company’s audited consolidated financial statements included in the Form 10-K.
The condensed consolidated financial statements reflect all adjustments of a normal and recurring nature that, in the opinion of management, are necessary to present fairly the Company’s financial position, results of operations and cash flows for the periods indicated. The preparation of the Company’s condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. The results of operations for the three months ended March 31, 2026 are not necessarily indicative of the results for any future period. Certain numbers presented throughout this document may not add precisely to the totals provided due to rounding. Absolute and percentage changes are calculated using the underlying amounts in thousands. The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Certain amounts in the condensed consolidated financial statements of the prior year have been reclassified to conform to current year presentation.
Effective as of
The accompanying condensed consolidated financial statements of the Company and subsidiaries have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.
As of March 31, 2026, the Company had total assets of $
(2) Significant Accounting Policies
Revenue Recognition
In accordance with Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, or Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for net product revenue and licensing revenue, see Note 7—Revenue Recognition.
Cash and Cash Equivalents and Restricted Cash
Cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with original maturities at the date of purchase of 90 days or less. Restricted cash represents cash and cash equivalents pledged to guarantee repayment of certain expenses which may be incurred for business travel under corporate credit cards held by employees.
Accounts Receivable, net
Accounts receivable, net, comprised of trade receivables, are generally due within
9
considered at risk or uncollectible, as well as an analysis of current receivables ageing and expected future write-offs. The expense associated with the allowance for doubtful accounts is recognized as selling, general, and administrative expense. The Company has not historically experienced any significant credit losses. All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected.
The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of March 31, 2026 and December 31, 2025:
In thousands |
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Gross trade accounts receivable |
|
$ |
|
|
$ |
|
||
Trade allowances |
|
|
( |
) |
|
|
( |
) |
Chargebacks |
|
|
( |
) |
|
|
( |
) |
Accounts receivable, net |
|
$ |
|
|
$ |
|
||
Inventory
The Company states inventory at the lower of cost or net realizable value. Cost is determined based on actual cost using the average cost method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The Company classifies inventory as long-term inventory when consumption of the inventory is expected beyond the next 12 months. The Company classifies finished goods expected to be sold within the next 12 months, and all of VASCEPA's active pharmaceutical ingredient, or API, as current inventory. An allowance is established when management determines that certain inventories may not be saleable. If inventory cost exceeds expected net realizable value due to obsolescence, damage or quantities in excess of expected demand, changes in price levels or other causes, the Company will reduce the carrying value of such inventory to net realizable value and recognize the difference as a component of cost of goods sold in the period in which it occurs. The Company capitalizes inventory purchases of saleable product from approved suppliers while inventory purchases from suppliers prior to regulatory approval are included as a component of research and development expense. The Company expenses inventory identified for use as marketing samples when they are packaged. The average cost reflects the actual purchase price of VASCEPA API.
Long-Lived Asset Impairment
The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to their carrying amount. If impairment is indicated, the assets are written down to fair value. Fair value is determined based on discounted forecasted cash flows or appraised values, depending on the nature of the assets.
Income Taxes
Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets and liabilities and operating loss carryforwards and other tax attributes using enacted rates expected to be in effect when those differences reverse. Valuation allowances are provided against deferred tax assets that are not more likely than not to be realized. Deferred tax assets and liabilities are classified as non-current in the condensed consolidated balance sheet.
The Company provides reserves for potential payments of tax to various tax authorities and does not recognize tax benefits related to uncertain tax positions and other issues. Tax benefits for uncertain tax positions are based on a determination of whether a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized, assuming that the matter in question will be decided based on its technical merits. The Company’s policy is to record interest and penalties as provision for income taxes.
The Company regularly assesses its ability to realize deferred tax assets. Changes in historical earnings performance, future earnings projections, and changes in tax laws, among other factors, may cause the Company to adjust its valuation allowance on deferred tax assets, which would impact the Company’s income tax expense in the period in which it is determined that these factors have changed.
Excess tax benefits and deficiencies that arise upon vesting or exercise of stock-based payments are recognized as an income tax benefit and expense, respectively, in the condensed consolidated statement of operations. Excess income tax benefits are classified as cash flows from operating activities and cash paid to taxing authorities arising from the withholding of Ordinary Shares from employees are classified as cash flows from financing activities.
The Company’s and its subsidiaries’ income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or IRS, and state tax authorities. The Company is currently under audit by the IRS for its
10
Loss per Share
Basic net loss per share is determined by dividing net loss by the weighted average number of Ordinary Shares outstanding during the period. Diluted net loss per share is determined by dividing net loss by diluted weighted average number of Ordinary Shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive Ordinary Shares, such as from the exercise of stock options and vesting of restricted stock units, or RSUs, calculated using the treasury stock method. In periods with reported net operating losses, all stock options and RSUs outstanding are deemed anti-dilutive such that basic and diluted net loss per share are equal.
The calculation of net loss and the number of Ordinary Shares and ADSs used to compute basic and diluted net loss per Ordinary Share and ADS for the three months ended March 31, 2026 and 2025 are as follows:
|
|
For the Three Months Ended March 31, |
|
|||||
In thousands |
|
2026 |
|
|
2025 |
|
||
Net loss—basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted average Ordinary Shares outstanding—basic and diluted |
|
|
|
|
|
|
||
Loss per Ordinary Share—basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
||
Weighted average ADS outstanding—basic and diluted |
|
|
|
|
|
|
||
Loss per ADS—basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
For the three months ended March 31, 2026 and 2025, the following potentially dilutive securities were not included in the computation of net loss per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures:
|
|
For the Three Months Ended March 31, |
|
|
|||||
In thousands |
|
2026 |
|
|
2025 |
|
|
||
Stock options |
|
|
|
|
|
|
|
||
Restricted stock and restricted stock units |
|
|
|
|
|
|
|
||
Stock options are anti-dilutive during periods of net earnings when the exercise price of the stock options exceeds the market price of the underlying securities on the last day of the reporting period. RSUs are anti-dilutive during periods of net earnings when underlying performance-based vesting requirements were not achieved as of the last day of the reporting period.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents, short-term investments, and accounts receivable. The Company maintains substantially all of its cash and cash equivalents and short-term investments in financial institutions believed to be of high credit quality.
A significant portion of the Company’s sales are to wholesalers in the pharmaceutical industry. The Company monitors the creditworthiness of customers to whom it grants credit terms and has not experienced any credit losses. The Company does not require collateral or any other security to support credit sales.
Concentration of Suppliers
The Company has contractual freedom to source the API for VASCEPA and to procure other services supporting its supply chain and has entered into supply agreements with multiple suppliers. The Company’s supply of product for commercial sale and clinical trials is dependent upon relationships with third-party manufacturers and suppliers.
The Company cannot provide assurance that its efforts to procure uninterrupted supply of VASCEPA to meet market demand will continue to be successful or that it will be able to renew current supply agreements on favorable terms or at all. Significant alteration to or disruption or termination of the Company’s current supply chain or the Company’s failure to enter into new and similar agreements in a timely fashion, if needed, could have a material adverse effect on its business, condition (financial and other), prospects or results of operations.
11
The Company currently has manufacturing agreements with multiple independent API manufacturers and several independent API encapsulators and packagers for VASCEPA manufacturing. Each of these API manufacturers, encapsulators and packagers is U.S. FDA-approved and certain of these API manufacturers, encapsulators and packagers are also approved by the European Regulatory Authorities for manufacturing VAZKEPA in Europe. These suppliers are also used by the Company to source supply to meet the clinical trial and commercial demands of its partners in other countries. Each of these suppliers has qualified and validated its manufacturing processes. There can be no guarantee that these or other suppliers with which the Company may contract in the future to manufacture VASCEPA or VASCEPA API will remain qualified to do so to its specifications or that these and any future suppliers will have the manufacturing capacity to meet potential global demand for VASCEPA.
Fair Value of Financial Instruments
The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:
Level 1—Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2—Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (e.g., interest rates, yield curves) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).
Level 3—Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.
The following tables present information about the estimated fair value of the Company’s assets and liabilities as of March 31, 2026 and December 31, 2025, and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:
|
|
March 31, 2026 |
|
|||||||||||||
In thousands |
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Asset: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury Securities |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Money Market Fund |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Repo Securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||
|
|
December 31, 2025 |
|
|||||||||||||
In thousands |
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Asset: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasury Securities |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Money Market Fund |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Repo Securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||
The carrying amount of the Company’s cash and cash equivalents approximates fair value because of their short-term nature. The cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with remaining maturities at the date of purchase of
The Company’s investments are stated at amortized cost, which approximates fair value. The Company does not intend to sell these investment securities and the contractual maturities are not greater than
Unrealized gains or losses are not recognized until maturity, except other-than-temporary unrealized losses, which are recognized in earnings in the period incurred. The Company evaluates securities with unrealized losses to determine whether such losses are other than temporary. The unrealized gain or loss for the three months ended March 31, 2026 and 2025 was a loss of $
The carrying amounts of accounts payable and accrued liabilities approximate fair value because of their short-term nature.
12
Segment and Geographical Information
Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision-maker, or CODM, in deciding how to allocate resources to an individual segment and in assessing performance of the segment. A single management team that reports to the Company’s CODM, who is the , comprehensively manages the business on an integrated basis for the purpose of allocating resources. Therefore, the Company has
The Company’s CODM does not currently assess segment performance or allocate resources based on a measure of total assets nor is it practical for the Company to disaggregate assets based on geography. Accordingly, a total asset measure has not been provided for segment disclosure.
The table below is a summary of the reportable segment profit or loss, including significant reportable segment expenses:
|
For the Three Months Ended March 31, |
|
|||||
In thousands |
2026 |
|
|
2025 |
|
||
US product revenue, net |
$ |
|
|
$ |
|
||
Europe product revenue, net |
|
|
|
|
|
||
RoW product revenue, net |
|
|
|
|
( |
) |
|
Total product revenue, net |
|
|
|
|
|
||
Licensing and royalty revenue |
|
|
|
|
|
||
Total revenue, net |
|
|
|
|
|
||
Less: Cost of goods sold |
|
|
|
|
|
||
Gross margin |
|
|
|
|
|
||
Operating expenses: |
|
|
|
|
|
||
Selling |
|
|
|
|
|
||
General and administrative (1) |
|
|
|
|
|
||
Research and development |
|
|
|
|
|
||
Payroll and payroll related expense |
|
|
|
|
|
||
Non-cash stock-based compensation expense |
|
|
|
|
|
||
Restructuring |
|
|
|
|
— |
|
|
Total operating expenses |
|
|
|
|
|
||
Operating loss |
|
( |
) |
|
|
( |
) |
Interest income, net |
|
|
|
|
|
||
Other income, net |
|
|
|
|
|
||
Loss from operations before taxes |
|
( |
) |
|
|
( |
) |
Provision for income taxes |
|
( |
) |
|
|
( |
) |
Segment & consolidated net loss |
$ |
( |
) |
|
$ |
( |
) |
(1)
Restructuring
The Company identifies a restructuring event as a program that is planned and controlled by management, and materially changes either the scope of the Company's business or the manner in which that business is conducted. The accounting for involuntary termination benefits that are provided pursuant to a one-time benefit arrangement are accounted for under ASC 420 – Exit or Disposal Cost Obligations, whereas involuntary termination benefits that are part of an ongoing written or substantive plan are accounted for under ASC 712 – Compensation – Nonretirement Postemployment Benefits. The Company accrues a liability for termination benefits under ASC 712 when it is probable that a liability has been incurred and the amount can be reasonably estimated and under ASC 420 when the termination benefits are communicated.
On June 24, 2025, the Company announced a global restructuring plan, the Global Restructuring Plan, in connection with the execution of an exclusive long-term license and supply agreement with Recordati, with the vast majority of estimated cost savings to
13
come from the elimination of commercial roles in the Company’s European operations. The Company anticipates that it will incur approximately $
The following table sets forth the components of the Company's restructuring charges for the three months ended March 31, 2026 (none for the three months ended March 31, 2025):
|
|
For the Three Months Ended March 31, |
|
|
In thousands |
|
2026 |
|
|
Employee restructuring separation charges |
|
$ |
|
|
Vendor contract charges |
|
|
|
|
Total restructuring expense |
|
|
|
|
Stock acceleration |
|
|
( |
) |
Total restructuring costs incurred |
|
$ |
|
|
The following table shows the change in restructuring liability, which is included within accrued expenses and other current liabilities:
In thousands |
|
Restructuring Liability |
|
|
Balance at December 31, 2025 |
|
$ |
|
|
Restructuring cash obligations incurred |
|
|
|
|
Payments |
|
|
( |
) |
Balance at March 31, 2026 |
|
$ |
|
|
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are adopted early by the Company or adopted as of the specified effective date.
In November 2024, the FASB issued Accounting Standards Update, or ASU, No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) and subsequently ASU No. 2025-01 Income Statement — Reporting Comprehensive Income —Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date, which requires a public business entity to disclose specific information about certain costs and expenses in the notes to its financial statements for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on the Company’s consolidated financial statements.
In July 2025, the FASB issued ASU No. 2025-05, Financial Instruments–Credit Losses, which provides guidance on an optional practical expedient when applying the guidance related to the estimation of expected credit losses for current accounts receivable and current contract assets resulting from transactions arising from contracts with customers. The guidance is effective for annual reporting periods beginning after December 15, 2025 and interim reporting periods within that fiscal year. The Company adopted this guidance during the current fiscal year, and the adoption did not have a material impact on the Company’s condensed consolidated financial statements.
In December 2025, the FASB issued new accounting guidance, ASU No. 2025-11, Interim Reporting (Topic 270): Narrow Scope Improvements, which clarifies the scope and requirements for interim financial statement disclosures. The amendment creates a comprehensive list of required interim disclosures and introduces a disclosure principle requiring entities to disclose, in interim periods, any event or change since the previous year-end that has a material effect on the entity. The guidance is effective for annual reporting periods beginning after December 15, 2027, and for interim periods within that fiscal year. The Company is currently evaluating the impact of adopting this guidance.
The Company believes that the impact of other recently issued but not yet adopted accounting pronouncements will not have a material impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations.
(3) Intangible Asset
Intangible asset consists of internal-use software, website development costs and milestone payments to the former shareholders of Laxdale related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in
14
the U.S. for the MARINE indication in 2012, the REDUCE-IT indication in 2019 and marketing approval in Europe in 2021. In accordance with ASC 350, the Company evaluates the remaining useful life of the intangible asset at each reporting period to determine if any events or circumstances warrant a revision to the remaining period of amortization. As of March 31, 2026, the intangible assets have an estimated weighted-average remaining useful life of
In thousands |
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Technology rights |
|
$ |
|
|
$ |
|
||
Accumulated amortization |
|
|
( |
) |
|
|
( |
) |
Intangible asset, net |
|
$ |
|
|
$ |
|
||
(4) Inventory
The Company capitalizes its purchases of saleable inventory of VASCEPA from suppliers that have been qualified by the U.S. FDA and other global regulatory agencies.
In thousands |
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
||
Total inventory (1) |
|
$ |
|
|
$ |
|
||
(5) Commitments and Contingencies
The Company accrues a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Company reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Company's views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Company's accrued liabilities would be recorded in the period in which such determination is made. For the matters referenced below, the amount of liability is not probable nor can the amount be reasonably estimated; therefore, accruals have not been made. In addition, in accordance with the relevant authoritative guidance, for matters in which the likelihood of material loss is at least reasonably possible, the Company provides disclosure of the possible loss or range of loss. If a reasonable estimate cannot be made, however, the Company will provide disclosure to that effect.
Litigation Updates
Except as described below, there have been no material updates to our litigation as reported in the Company’s Form 10-K.
On November 30, 2020, the Company filed a patent infringement lawsuit against Hikma for making, selling, offering to sell, and importing generic icosapent ethyl capsules in and into the U.S. in a manner that the Company alleges induced the infringement of patents covering the use of VASCEPA to reduce specified CV risk. On January 4, 2022, the District Court for the District of Delaware granted a motion to dismiss the Company's lawsuit for failure to state a claim. Thereafter, the Company appealed to the Court of Appeals for the Federal Circuit. On June 25, 2024, the Federal Circuit issued a decision reversing the district court, finding that the Company's allegations against Hikma plausibly state a claim alleging Hikma actively induced infringement of the asserted patents. Hikma filed a petition for rehearing en banc on August 22, 2024, which was denied on October 17, 2024. On February 14, 2025, Hikma filed a petition for a writ of certiorari with the Supreme Court of the U.S. seeking review of the Federal Circuit decision reversing the district court. On January 16, 2026, the Supreme Court granted Hikma’s petition to review the Federal Circuit decision, and thereafter, on January 20, 2026, the District Court granted a stipulation proposed by the parties to stay the District Court proceedings pending the conclusion of Hikma’s appeal before the Supreme Court. On February 18, 2026, Hikma filed their Brief for Petitioners, Amarin filed their Brief for Respondents on March 20, 2026, and on April 13, 2026, Hikma filed their Reply Brief for Petitioners. Oral argument is scheduled for April 29, 2026.
On March 31, 2023, the Company’s former chief executive officer, Karim Mikhail, filed a complaint against the Company and certain of its affiliates in the Superior Court of New Jersey, Law Division – Somerset County, captioned Mikhail v. Amarin Corporation, plc (Docket No. SOM-L-000366-23), concerning Mr. Mikhail’s alleged “constructive termination” from the Company. The complaint seeks unspecified damages arising from claims for breaches of his employment agreement, Executive Severance and Change of Control Plan, and the implied covenant of good faith and fair dealing. On April 3, 2023, the case moved to the U.S. District Court for the District of New Jersey (Civ. No. 3:23-cv-01856). On June 30, 2023, all defendants moved to dismiss this case without prejudice
15
due to lack of jurisdiction. On March 4, 2024, the District Court granted the motion in part and denied the motion in part, permitting the parties to pursue limited discovery on the issue of personal jurisdiction. On March 20, 2025, the Company filed a new motion to dismiss for failure of plaintiff to state a claim. On November 26, 2025, the District Court granted Amarin's renewed motion to dismiss Karim Mikhail's first amended complaint in its entirety. On December 30, 2025, plaintiff filed a second amended complaint. In February 2026, the court issued an order granting Amarin permission to file a Motion to Dismiss, thereafter adopting a briefing schedule proposed by the parties providing Amarin with a deadline of May 20, 2026 to file such motion. The Company believes it has valid defenses and will vigorously defend against the claims but cannot predict the outcome.
On April 27, 2021 and February 21, 2023, Dr. Reddy’s and Hikma, respectively, filed complaints against the Company in the U.S. District Court for the District of New Jersey, Civil action No. 21-cv-10309 and No. 23-cv-01016, alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA. DRL's complaint also includes a state law tortious interference claim related to the same alleged conduct. On March 28, 2024, Teva Pharmaceuticals USA, Inc., or Teva, filed a complaint against the Company in the U.S. District Court for the District of New Jersey, Civil action No. 24-cv-04341, alleging various antitrust violations analogous to those made by Dr. Reddy’s and Hikma. Further, on June 14, 2024, Apotex, Inc., or Apotex, filed a complaint against the Company in the U.S. District Court for the District of New Jersey, Civil action No. 24-cv-07041, alleging various antitrust violations analogous to those made by Dr. Reddy’s, Hikma and Teva, as well as a breach of contract claim related to the same alleged conduct. Apotex also seeks declaratory judgement regarding the applicability of a 2020 settlement agreement to its antitrust claims. In October 2024, Apotex amended its complaint to add as defendants KD Pharma-Bexbach GmbH; KD Swiss GmbH; Marine Ingredients, LLC; Innova Softgel, LLC; 03 Holding GmbH; Capiton AG. Relief sought include an unspecified amount of damages for alleged economic harm to each of Dr. Reddy’s, Hikma, Teva and Apotex, treble damages, other costs and fees and injunctive relief against the alleged violative activities. On December 9, 2025, the Company filed motions for judgment on the pleadings to dismiss the claims of Teva and Apotex, based on prior settlement agreements Amarin entered into with Teva and Apotex on May 25, 2018, and June 16, 2020, respectively, relating to generic versions of Amarin’s branded product VASCEPA. On February 2, 2026, the Court denied both motions.
The Company is named as a defendant in six putative antitrust class action lawsuits in the District Court for the District of New Jersey, as displayed in the table below. Each of the six antitrust putative class action lawsuits allege the Company violated federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. The Indirect Purchaser Plaintiffs also assert related state antitrust, consumer protection, and unjust enrichment claims. The Indirect Purchaser Plaintiffs seek relief in the form of an unspecified amount of compensatory damages, treble damages, other costs and fees, restitution, and declaratory and injunctive relief against the alleged violative activities. The Direct Purchaser Plaintiff seeks treble damages and other costs and fees. On April 14, 2026, the Company agreed to a Confidential Settlement Agreement and Release with the named Indirect Purchaser Plaintiffs and the Direct Purchaser Plaintiff, together, the Purchaser Plaintiffs, wherein in exchange for a negotiated settlement payment, the Purchaser Plaintiffs will voluntarily dismiss with prejudice all pending claims against the Company. The negotiated settlement payment was recognized within selling, general and administrative expenses on the condensed consolidated statement of operations for the three months ended March 31, 2026 and within accrued expenses and other current liabilities on the condensed consolidated balance sheet as of March 31, 2026.
Lawsuits |
|
Civil Action # |
|
Direct/Indirect Purchasers |
|
Date Filed |
|
|
|
|
|||
|
|
|
||||
|
|
|
||||
|
|
|
||||
|
|
|
||||
|
|
|
Such antitrust litigation can be lengthy, costly and could materially affect and disrupt the Company’s business. The Company cannot predict when these matters will be resolved, their outcome or their potential impact on the Company’s business. The Company believes it has valid defenses and will vigorously defend against the claims. If it is determined that the Company has violated antitrust law, the Company could be subject to significant civil fines and penalties.
In addition to the above, in the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. The Company believes it has valid defenses and will vigorously defend against the claims but cannot predict the outcome. The Company is unable to reasonably estimate the loss exposure, if any, associated with these claims.
16
Milestone and Supply Purchase Obligations
The Company currently has long-term supply agreements with multiple API suppliers and encapsulators. The Company is relying on these suppliers to meet current and potential future global demand for VASCEPA. Certain supply agreements require annual minimum volume commitments by the Company and certain volume shortfalls may require payments for such shortfalls.
These agreements include requirements for the suppliers to meet certain product specifications and qualify their materials and facilities with applicable regulatory authorities, including the U.S. FDA. The Company has incurred certain costs associated with the qualification of product produced by these suppliers.
As of March 31, 2026, the Company has a total of approximately $
Under the Laxdale agreement, upon receipt of a marketing approval in Europe for a further indication of VASCEPA (or further indication of any other product acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment (at the sole option of each such former shareholder) of £
The Company has no provision for any of these obligations since the amounts are either not paid or payable as of March 31, 2026.
(6) Equity
ADSs
On
During the three months ended March 31, 2026 and 2025, except as described above, the Company did not engage in any transactions involving its ADSs. Refer to Incentive Equity Awards below for discussions of Ordinary Shares issued as a result of stock option exercises and vesting of RSUs.
Ordinary Shares
There was no Ordinary Share activity during the three months ended March 31, 2026 and 2025, except as described in Incentive Equity Awards below.
Incentive Equity Awards
The following table summarizes the aggregate number of Ordinary Shares underlying stock options and RSUs outstanding under the Amarin Corporation plc 2020 Stock Incentive Plan, as amended, or the 2020 Plan, as of March 31, 2026:
|
March 31, 2026 |
|
|
Outstanding stock options |
|
|
|
% of outstanding on a fully-diluted basis |
|
% |
|
Outstanding RSUs |
|
|
|
% of outstanding on a fully-diluted basis |
|
% |
|
The following table represents equity awards activity during the three months ended March 31, 2026 and 2025:
|
Three months ended March 31, |
|
|||||
|
2026 |
|
|
2025 |
|
||
Ordinary Shares issued in settlement of vested RSUs |
|
|
|
|
|
||
Ordinary Shares retained for settlement of employee tax obligations ─ RSUs |
|
|
|
|
|
||
Ordinary Shares issued in settlement of vested Performance-based RSUs (1) |
|
|
|
|
|
||
Ordinary Shares retained for settlement of employee tax obligations ─ Performance-based RSUs |
|
|
|
|
|
||
17
In January 2026, the Company granted RSUs for a total of
In January 2025, the Company granted RSUs for a total of
(7) Revenue Recognition
The Company sells VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty retail pharmacy providers in the U.S. and commercial partners globally, or collectively, its distributors or its customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers. Patients are required to have a prescription in order to purchase VASCEPA. In addition to distribution agreements with distributors, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s product.
Within the U.S., revenues from product sales are recognized when the distributor obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the distributor and in certain instances upon shipment. Payments from distributors are generally received
Outside of the U.S., our product revenue is derived from the sales of VASCEPA to our commercial partners based on the net price for VASCEPA established in our contracts with such partners. These commercial partners then resell the product in their agreed commercial territory. Revenues from sales to our international commercial partners are recognized when the commercial partners obtain control of our product.
Reserves for Variable Consideration
Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from (a) trade allowances, such as invoice discounts for prompt pay and distributor fees, (b) estimated government and private payor rebates and chargebacks and discounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives that are offered within contracts between the Company and its distributors, health care providers, payors and other indirect customers relating to the Company’s sales of its product. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the distributor) or as a current liability (if the amount is payable to a party other than a distributor). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.
Trade Allowances: The Company generally provides invoice discounts on VASCEPA sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. The payment terms for sales to distributors in the U.S. and Europe generally include a
Rebates, Chargebacks and Discounts: The Company contracts with Medicaid, Medicare, other government agencies and various private organizations, or collectively, Third-party Payors, so that VASCEPA will be eligible for purchase by, or partial or full reimbursement from, such Third-party Payors. The Company has withdrawn from the Medicaid Drug Rebate program and the 340B drug pricing program effective October 1, 2024. The Company estimates the rebates, chargebacks and discounts it will provide to Third-party Payors and deducts these estimated amounts from its gross product revenues at the time the revenues are recognized. The Company estimates these reserves based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction
18
of product revenue and the establishment of a current liability, which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company estimates the rebates, chargebacks and discounts that it will provide to Third-party Payors based upon (i) the Company’s contracts with these Third-party Payors, (ii) the government-mandated discounts applicable to government-funded programs, (iii) information obtained from the Company’s distributors and (iv) information obtained from other third parties regarding the payor mix for VASCEPA. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period.
Product Returns: The Company’s distributors have the right to return unopened unprescribed VASCEPA during the 18-month period beginning six months prior to the labeled expiration date and ending 12 months after the labeled expiration date. The expiration date for VASCEPA 1-gram and 0.5-gram size capsules is currently
Other Incentives: Other incentives that the Company offers to indirect customers include co-pay mitigation rebates provided by the Company to commercially insured patients who have coverage for VASCEPA and who reside in states that permit co-pay mitigation programs. The Company’s co-pay mitigation program is intended to reduce each participating patient’s portion of the financial responsibility for VASCEPA’s purchase price to a specified dollar amount. Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program in order to establish its accruals for co-pay mitigation rebates. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. The Company adjusts its accruals for co-pay mitigation rebates based on actual redemption activity and estimates regarding the portion of issued co-pay mitigation rebates that it estimates will be redeemed.
The following tables summarize activity in each of the net product revenue allowance and reserve categories described above for the three months ended March 31, 2026 and 2025:
In thousands |
|
Trade |
|
|
Rebates, |
|
|
Product |
|
|
Other |
|
|
Total |
|
|||||
Balance as of December 31, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Provision related to current period sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Provision related to prior period sales |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Credits/payments made for current period sales |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Credits/payments made for prior period sales |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Balance as of March 31, 2026 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
In thousands |
|
Trade |
|
|
Rebates, |
|
|
Product |
|
|
Other |
|
|
Total |
|
|||||
Balance as of December 31, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Provision related to current period sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|||||
Provision related to prior period sales |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
$ |
( |
) |
Credits/payments made for current period sales |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
$ |
( |
) |
Credits/payments made for prior period sales |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
$ |
( |
) |
Balance as of March 31, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
19
Such net product revenue allowances and reserves are included within accrued expenses and other current liabilities within the condensed consolidated balance sheets, with the exception of trade allowances and chargebacks, which are included within accounts receivable, net, as discussed above.
Licensing Revenue
The Company enters into licensing agreements which are within the scope of Topic 606, under which it licenses certain rights to VASCEPA for uses that are currently commercialized and under development by the Company. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments results in licensing and royalty revenues.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
In determining performance obligations, management evaluates whether the license is distinct from the other performance obligations with the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in the determination include the stage of development of the license delivered, research and development capabilities of the partner and the ability of partners to develop and commercialize VASCEPA independent of the Company.
Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone Payments: At the inception of each arrangement that includes development, regulatory and commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone as well as the level of effort and investment required. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenues and earnings in the period of adjustment.
Royalty Payments: At the inception of each arrangement that includes royalty-based payments, the Company evaluates whether the royalties relate to the license of intellectual property, in which case they are accounted for under the royalty constraint within ASC 606 and recognized when the later of the subsequent sale or usage occurs or when the performance obligations have been satisfied. If the royalties do not relate to the licensing of intellectual property, the royalties are accounted for under the variable consideration constraint within ASC 606 and are recognized in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue will not occur when the uncertainty around the variable consideration is subsequently resolved. Royalty payments that fall within the variable consideration constraint take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The royalties that are considered variable consideration are recognized when the uncertainty related to the variable consideration is subsequently resolved. At the end of each subsequent reporting period, the Company reevaluates the circumstances and recognizes royalties that are no longer constrained.
The Company receives payments from its customers based on billing schedules established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing
20
component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be
(8) Development, Commercialization and Supply Agreements
In-licenses
Mochida Pharmaceutical Co., Ltd.
In June 2018, the Company entered into a collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the omega-3 acid, EPA, or eicosapentaenoic acid. Among other terms in the agreement, the Company obtained an exclusive license to certain Mochida intellectual property to advance the Company’s interests in the U.S. and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for the Company’s commercialization in the U.S. and certain other territories. The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development.
Upon closing of the collaboration agreement, the Company made a non-refundable, non-creditable upfront payment of approximately $
In February 2026 and 2025, the Company exercised certain rights under the agreement, resulting in payments of $
Out-licenses
Eddingpharm (Asia) Macao Commercial Offshore Limited
In February 2015, the Company entered into a Development, Commercialization and Supply Agreement, or the DCS Agreement, with Edding, related to the development and commercialization of VASCEPA in Mainland China, Hong Kong, Macau and Taiwan, or collectively, the China Territory. Under the terms of the DCS Agreement, the Company granted to Edding an exclusive (including as to the Company) license with the right to sublicense development and commercialization of VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company based on the Company’s MARINE, ANCHOR and REDUCE-IT clinical trials of VASCEPA.
Under the DCS Agreement, Edding is solely responsible for development and commercialization activities in the China Territory and associated expenses. The Company provides development assistance and is responsible for supplying finished and later bulk drug product at defined prices under negotiated terms. The Company retains all VASCEPA manufacturing rights. Edding agreed to certain restrictions regarding the commercialization of competitive products globally and the Company agreed to certain restrictions regarding the commercialization of competitive products in the China Territory.
The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Edding, is a customer. The Company identified the following performance obligations at the inception of the DCS Agreement: (1) the exclusive license to develop and commercialize VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company; (2) the obligation to participate in various steering committees; and (3) ongoing development and regulatory assistance. Based on the analysis performed, the Company concluded that the identified performance obligations are not distinct and therefore a combined performance obligation.
The transaction price is comprised of the following upfront payments and milestones:
In thousands |
|
|
|
|
|
|
Transaction Price Components |
|
Achieved |
|
Amount |
|
|
Upfront fee |
|
February 2015 |
|
$ |
|
|
Submission of the CTA for the MARINE indication |
|
March 2016 |
|
|
|
|
Approval of VASCEPA under the MARINE indication |
|
March 2017 |
|
|
|
|
Submission of the CTA for the REDUCE-IT indication |
|
October 2023 |
|
|
|
|
Approval of VASCEPA under the REDUCE-IT indication |
|
June 2024 |
|
|
|
|
Regulatory Development Support |
|
Various |
|
|
|
|
Total Transaction Price |
|
|
|
$ |
|
|
In addition to the non-refundable, upfront and regulatory milestone payments described above, the Company is entitled to receive tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens. The achievement
21
of sales-based milestone events occurs when annual aggregate net sales of VASCEPA in the China Territory equals or exceeds certain specified thresholds, and range from $
None of the other clinical or regulatory milestones has been included in the transaction price, as all milestone amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones, including royalties, will be recognized when the related sales occur and therefore have also been excluded from the transaction price. The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
The Company fully recognized the transaction price as of June 30, 2024.
The Company recognized royalties of $
Biologix FZCo
In March 2016, the Company entered into an agreement with Biologix FZCo, or Biologix, a company incorporated under the laws of the United Arab Emirates, to register and commercialize VASCEPA in several Middle Eastern and North African countries. Under the terms of the distribution agreement, the Company granted Biologix a non-exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Middle East and North Africa territory. Upon closing of the agreement, the Company received a non-refundable upfront payment, which has been fully recognized as of June 30, 2024. The Company is entitled to receive all payments based on total product sales and pays Biologix a service fee in exchange for its services, whereby the service fee represents a percentage of gross selling price which is subject to a minimum floor price.
The Company received approval of VASCEPA under the MARINE and REDUCE-IT indications in the following countries:
Country |
|
MARINE |
|
REDUCE-IT |
|
Launch Date |
Lebanon |
|
|
|
|||
United Arab Emirates |
|
|
|
|||
Qatar |
|
|
|
|||
Bahrain |
|
|
|
|||
Kuwait |
|
|
|
|||
Saudi Arabia |
|
|
|
The Company recognized net product revenue of $
HLS Therapeutics, Inc.
In September 2017, the Company entered into an agreement with HLS Therapeutics, Inc., or HLS, a company incorporated under the laws of Canada, to register, commercialize and distribute VASCEPA in Canada. Under the agreement, HLS is responsible for regulatory and commercialization activities and associated costs. The Company is responsible for providing assistance towards local filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities.
The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, HLS, is a customer. The Company identified the following performance obligations at the inception of the contract: (1) license to HLS to develop, register, and commercialize VASCEPA in Canada; (2) support general development and regulatory activities; and (3) participate in various steering committees. Based on the analysis performed, the Company concluded that the identified performance obligations in the agreement are not distinct and therefore a combined performance obligation.
The transaction price is comprised of the following upfront payments and milestones:
In thousands |
|
|
|
|
|
|
Transaction Price Components |
|
Achieved |
|
Amount |
|
|
Upfront fee |
|
September 2017 |
|
$ |
|
|
Achievement of the REDUCE-IT trial primary endpoint |
|
September 2018 |
|
|
|
|
Approval from Health Canada |
|
December 2019 |
|
|
|
|
Regulatory exclusivity from the Office of Patented Medicines and Liaison |
|
January 2020 |
|
|
|
|
Total Transaction Price |
|
|
|
$ |
|
|
22
In addition to the non-refundable, upfront and regulatory milestone payments just described, the Company is entitled to receive certain sales-based milestone payments of up to an additional $
The Company fully recognized the transaction price as of June 30, 2023.
The Company recognized royalties of $
CSL Seqirus
In February 2023, the Company entered into an agreement with CSL Seqirus, or CSL, to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand. The Company received an upfront payment of $
The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, CSL, is a customer. The Company identified the following distinct performance obligations at the inception of the contract: an exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Australia and New Zealand territories.
The transaction price includes the $
The Company recognized net product revenue of $
Recordati Industria Chimica e Farmaceutica S.p.A.
In June 2025, the Company entered into an exclusive long-term license and supply agreement with Recordati, or the Recordati Licensing Agreement, related to the development and commercialization of VASCEPA in
23
Country |
|
Individual Reimbursement |
|
National Reimbursement |
|
Product Availability |
|
Launch Date |
Sweden |
|
– |
|
|
|
|||
Finland |
|
– |
|
|
|
|||
England/Wales/Northern Ireland |
|
– |
|
|
|
|||
Spain |
|
– |
|
|
|
|||
Netherlands |
|
– |
|
|
|
|||
Scotland |
|
– |
|
|
|
|||
Greece (1) |
|
– |
|
|
|
|||
Portugal |
|
– |
|
|
|
|||
Italy |
|
– |
|
|
|
|||
Slovenia (2) |
|
– |
|
|
|
|||
Austria |
|
|
|
|
– |
|||
Denmark |
|
|
– |
|
|
– |
(1) Vianex will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA.
(2) Salus will be the sole and exclusive distributor of VAZKEPA in the Slovenian territory to import, register, distribute and commercialize VAZKEPA.
The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Recordati, is a customer. The Company identified the following distinct performance obligation at the inception of the contract: an exclusive license to use its intellectual property; regulatory approvals; and regulatory documents in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Recordati Territory. The Company will be responsible for supplying finished product to Recordati at a set price, as defined in the Recordati Licensing Agreement.
The Company received an upfront payment of $
The transaction price includes the $
The Company recognized net product revenue of $
(9) Leases
Lessee
The Company leases office space under operating leases. The lease liability is initially measured at the present value of the lease payments to be made over the lease term. Lease payments are comprised of the fixed and variable payments to be made by the Company to the lessor during the lease term minus any incentives or rebates or abatements receivable by the Company from the lessor or the owner. Payments for non-lease components do not form part of lease payments. The lease term includes renewal options only if these options are specified in the lease agreement and if failure to exercise the renewal option imposes a significant economic penalty for the Company. As there are no significant economic penalties, renewal cannot be reasonably assured and the lease terms for the office space do not include any renewal options. The Company has not entered into any leases with related parties. The Company accounts for short-term leases (i.e., lease term of
The Company has determined that the rate implicit in the lease is not determinable and the Company does not have borrowings with similar terms and collateral. Therefore, the Company considered a variety of factors, including the Company’s credit rating, observable debt yields from comparable companies with a similar credit profile and the volatility in the debt market for securities with similar terms, in determining that
24
On February 5, 2019, the Company entered into a lease agreement for new office space in Bridgewater, New Jersey, or the Lease. The Lease commenced on
On November 17, 2021, the Company entered into a lease agreement for office space in Zug Switzerland, or the Zug Lease. The Zug Lease commenced on
On April 26, 2024, the Company entered into a lease agreement for new office space in Dublin, Ireland, or the Subsequent Dublin Lease. The Subsequent Dublin Lease commenced on
On February 11, 2025, the Company entered into an amended lease agreement, which amended the Subsequent Dublin Lease, for additional office space in Dublin, Ireland, or the Amended Subsequent Dublin Lease. The Amended Subsequent Dublin Lease commenced on
Prior to the licensing agreement with Recordati, the Company had lease agreements for various automobiles with terms ranging from month-to-month up to
The total operating lease liability is $
The lease expense for the three months ended March 31, 2026 and 2025 is $
The table below depicts a maturity analysis of the Company’s undiscounted payments for its operating lease liabilities and their reconciliation with the carrying amount of lease liability presented in the statement of financial position as of March 31, 2026:
In thousands |
|
Undiscounted lease payments |
|
|
Remainder of 2026 |
|
$ |
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
Total undiscounted payments |
|
$ |
|
|
Discount Adjustments |
|
$ |
( |
) |
|
$ |
|
||
Long-term operating lease liability |
|
$ |
|
|
Lessor
The Company classifies contractual lease arrangements entered as a lessor as a sales-type, direct financing or operating lease as described in ASC 842. For sales-type leases, the Company derecognizes the leased asset and recognizes the lease investment on the balance sheet.
On January 20, 2023, the Company entered into a sublease agreement, or the Sublease, for
25
The components of lease income are as follows:
|
|
For the Three Months Ended March 31, |
|
|||||
In thousands |
|
2026 |
|
|
2025 |
|
||
Interest income from sales-type leases |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|||
Total |
|
$ |
|
|
$ |
|
||
Future minimum sales-type lease and operating lease receivables as of March 31, 2026 are as follows:
In thousands |
|
Sales-Type Leases |
|
|
Operating Leases |
|
||
Remainder of 2026 |
|
$ |
|
|
$ |
|
||
2027 |
|
|
|
|
|
|
||
2028 |
|
|
|
|
|
|
||
2029 |
|
|
|
|
|
|
||
2030 |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
26
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
This Quarterly Report on Form 10-Q, or this Quarterly Report, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements reflect our plans, estimates and beliefs. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Because of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not transpire. We discuss many of these risks in Part I, Item 1A under the heading “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, or our Annual Report, and under Part II, Item IA, “Risk Factors” of this Quarterly Report.
Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our estimates and assumptions only as of the date of this document. You should read this document with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we do not undertake any obligation to publicly update or revise any forward-looking statements contained in this report, whether as a result of new information, future events or otherwise.
The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report, and the audited consolidated financial statements and accompanying notes, as well as Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report.
Overview
We are a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk.
Our commercialized product, VASCEPA® (icosapent ethyl) was first approved by the United States, or U.S., Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, or HTG, or the MARINE indication. On December 13, 2019, the U.S. FDA approved another indication and label expansion for VASCEPA based on the results of our long-term CV outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent CV risk in select high risk-patients, or the REDUCE-IT indication.
On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VASCEPA, under the brand name VAZKEPA®, hereinafter along with VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of CV events in high-risk statin-treated adult patients who have elevated TGs (>150 mg/dL) and either established CV disease or diabetes and at least one additional CV risk event. On April 22, 2021, we announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce CV risk. Collectively, Committee for Medicinal Products for Human Use, or CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.
We and our seven commercial partners are in various stages: seeking or maintaining regulatory approval, obtaining government or private pricing and reimbursement, and/or commercialization. VASCEPA and VAZKEPA approvals and applications for approval globally reference either the U.S. New Drug Application, or NDA, core dossier or the EMA core dossier.
VASCEPA (U.S. NDA Core Dossier) |
|
VAZKEPA (EMA Core Dossier) |
Amarin (US) |
|
Recordati Industria Chimica e Farmaceutica S.p.A "Recordati" (Europe) (1) |
HLS Therapeutics Inc. "HLS" (Canada) |
|
CSL Seqirus "CSL"(Australia/New Zealand) |
Biologix FZCo "Biologix" (Middle East North Africa, or MENA) |
|
Lotus Pharmaceuticals, "Lotus" (Southeast Asia) |
Eddingpharm (Asia) Macao Commercial Offshore Limited "Edding" (China Territory) |
|
Neopharm (Israel) 1996 Ltd. "Neopharm" (Israel) |
(1) - As part of the Recordati partnership, agreements with Vianex S.A "Vianex" (Greece), Magnapharm Marketing & Sales Romania S.R.L. "Magnapharm" (Romania), and Salus, Veletrgovina, d.o.o, "Salus" (Slovenia) has been transitioned to Recordati.
We are responsible for supplying VASCEPA to all markets in which the branded product is sold, including countries where the drug is promoted and sold via collaboration with third-party partners that compensate us for such supply. We are not responsible for providing any generic company with drug product. The Company operates in one business segment.
27
United States
VASCEPA is sold principally to a limited number of major wholesalers, as well as selected regional wholesalers and retail and mail order pharmacy providers, or collectively, our distributors or our customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients. Since VASCEPA was made commercially available in 2013, approximately 30 million estimated normalized total prescriptions of VASCEPA have been reported by Symphony Health. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, several of our patents covering the MARINE indication were declared invalid. As a result, the following generic versions of icosapent ethyl have obtained U.S. FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market:
Company (ANDA Holder) |
|
Distributed / Licensee |
|
FDA MARINE Indication Approval |
|
1-gram Launch Date |
|
0.5-gram Launch Date |
|
Active |
Hikma Pharmaceuticals USA Inc. |
|
Hikma Pharmaceuticals USA Inc.; |
|
May 2020 |
|
November 2020 |
|
March 2023 |
|
Yes |
Dr. Reddy’s Laboratories, Inc. |
|
Dr. Reddy’s Laboratories, Inc. |
|
August 2020 |
|
June 2021 |
|
June 2023 |
|
Yes |
Teva Pharmaceuticals USA, Inc. |
|
Teva Pharmaceuticals USA, Inc.; |
|
September 2020 |
|
January 2023 |
|
September 2022 |
|
Yes |
Apotex, Inc. |
|
Apotex, Inc.; |
|
June 2021 |
|
January 2022 |
|
– |
|
Yes |
Zydus Lifesciences |
|
Zydus Pharmaceuticals USA |
|
April 2023 |
|
August 2024 |
|
June 2024 |
|
Yes |
Onesource Specialty (Amneal Original Filer) |
|
Amneal Pharmaceuticals |
|
September 2023 |
|
April 2024 |
|
April 2024 |
|
Yes |
Humanwell Puracap |
|
Epic Pharma |
|
December 2023 |
|
March 2024 |
|
– |
|
Yes |
Ascent Pharmaceuticals, Inc. |
|
Camber Pharmaceuticals; |
|
December 2023 |
|
April 2024 |
|
April 2024 |
|
Yes |
Qilu Pharmaceutical Co Ltd |
|
– |
|
November 2024 |
|
– |
|
– |
|
No |
PharmaObedient (Spriaso Original Filer) |
|
– |
|
December 2024 |
|
– |
|
– |
|
No |
Xiamen LP Pharma Co. |
|
Vitruvias Therapeutics |
|
August 2025 |
|
January 2026 |
|
– |
|
Yes |
We obtain data from a third party, Symphony Health, which collects and reports estimates of weekly, monthly, quarterly and annual prescription information. There is a limited amount of information available to determine the actual number of total prescriptions for products like VASCEPA during such periods. The vendor's estimate utilizes a proprietary projection methodology and is based on a combination of data received from pharmacies and other distributors, as well as historical data when actual data is unavailable. Based on data from Symphony Health, the below chart represents the estimated number of normalized total VASCEPA prescriptions in the U.S.
28
Normalized total prescriptions represent the estimated total number of VASCEPA prescriptions dispensed to patients, calculated on a normalized basis (i.e., one month’s supply, or total capsules dispensed multiplied by the number of grams per capsule divided by 120 grams). Inventory levels at wholesalers tend to fluctuate based on seasonal factors, prescription trends and other factors.
The previous calculations of prescription levels by this vendor can change between periods and can be significantly affected by lags in data reporting from various sources or by changes in pharmacies and other distributors providing data. Such methods can from time to time result in significant inaccuracies in information when ultimately compared with actual results. These inaccuracies have historically been most prevalent and pronounced during periods of time of inflections upward or downward in rates of use. Further, data for a single and limited period may not be representative of a trend or otherwise predictive of future results.
Partnerships
One of our core areas of focus is continuing to work on generating revenue from our partnerships in key international markets. We and our partners have obtained varying levels of indication approvals and initiated or are in the process of initiating commercial launches in various territories where our partners have access. We and our partners continue to seek additional regulatory approvals in the countries in which our partners operate. We have agreements in place with the following partners within the respective territories:
Partner |
|
Agreement Date |
|
Country |
|
MARINE Approval |
|
REDUCE-IT Approval |
|
Launch Date |
Edding (1) |
|
February 2015 |
|
Mainland China |
|
June 2023 |
|
June 2024 |
|
October 2023 |
Hong Kong |
|
– |
|
February 2023 |
|
May 2024 |
||||
Biologix (2) |
|
March 2016 |
|
Lebanon |
|
March 2018 |
|
August 2021 |
|
June 2018 |
United Arab Emirates |
|
July 2018 |
|
October 2021 |
|
February 2019 |
||||
Qatar |
|
December 2019 |
|
April 2021 |
|
May 2022 |
||||
Bahrain |
|
April 2021 |
|
April 2022 |
|
September 2023 |
||||
Kuwait |
|
December 2021 |
|
March 2023 |
|
September 2023 |
||||
Saudi Arabia |
|
March 2022 |
|
June 2023 |
|
September 2023 |
||||
HLS |
|
September 2017 |
|
Canada |
|
– |
|
December 2019 |
|
February 2020 |
CSL |
|
February 2023 |
|
Australia |
|
– |
|
November 2022 |
|
October 2024 |
New Zealand |
|
– |
|
January 2023 |
|
– |
||||
Neopharm (3) |
|
August 2023 |
|
Israel |
|
– |
|
March 2023 |
|
May 2024 |
Lotus (4) |
|
August 2023 |
|
South Korea |
|
– |
|
May 2025 |
|
– |
|
|
Singapore |
|
– |
|
December 2025 |
|
– |
||
Recordati (5) |
|
June 2025 |
|
Europe (6) |
|
– |
|
March 2021 |
|
(6) |
(1) VASCEPA is under registration in Macau and Taiwan in the China Territory with Edding.
(2) VASCEPA is under registration in additional countries in the MENA region with Biologix.
(3) VASCEPA is under registration in additional countries in the Israel territory with Neopharm.
(4) VASCEPA is under registration in additional countries in the ASEAN region with Lotus.
(5) VASCEPA is under registration in 59 countries focused in Europe with Recordati.
(6) Refer to table below for listing of European countries with VAZKEPA currently available.
29
In 2021, we received marketing authorization and regulatory approval in the EU, England, Wales and Scotland with 10 years of market protection, and in April 2024, we were issued a patent that extended our exclusivity to 2039.
In June 2025, we entered into an exclusive long-term license and supply agreement with Recordati, or the Recordati Licensing Agreement, related to the development and commercialization of VAZKEPA in 59 countries focused in Europe, or the Recordati Territory. As a result of the Recordati Licensing Agreement, Recordati is solely responsible for commercializing VAZKEPA in the Recordati Territory. Recordati may sell VAZKEPA pursuant to the product reimbursements we have already obtained in Europe, as shown below, and the agreements with existing partners in the Recordati Territory being transitioned to Recordati. In addition, Recordati will use commercially reasonable efforts to pursue future product reimbursements and approvals in the Recordati Territory.
Country |
|
Individual Reimbursement |
|
National Reimbursement |
|
Product Availability |
|
Launch Date |
Sweden |
|
– |
|
March 2022 |
|
March 2022 |
|
March 2022 |
Finland |
|
– |
|
October 2022 |
|
December 2022 |
|
December 2022 |
England/Wales/Northern Ireland |
|
– |
|
July 2022 |
|
October 2022 |
|
October 2022 |
Spain |
|
– |
|
July 2023 |
|
September 2023 |
|
September 2023 |
Netherlands |
|
– |
|
August 2023 |
|
September 2023 |
|
September 2023 |
Scotland |
|
– |
|
August 2023 |
|
August 2023 |
|
September 2023 |
Greece (1) |
|
– |
|
May 2024 |
|
June 2024 |
|
June 2024 |
Portugal |
|
– |
|
August 2024 |
|
August 2024 |
|
September 2024 |
Italy |
|
– |
|
December 2024 |
|
December 2024 |
|
January 2025 |
Slovenia (2) |
|
– |
|
September 2025 |
|
October 2025 |
|
October 2025 |
Austria |
|
September 2022 |
|
February 2025 |
|
September 2022 |
|
– |
Denmark |
|
June 2022 |
|
– |
|
June 2022 |
|
– |
(1) Vianex will be the sole and exclusive distributor of VAZKEPA in the Greek territory to import, register, distribute and commercialize VAZKEPA.
(2) Salus will be the sole and exclusive distributor of VAZKEPA in the Slovenian territory to import, register, distribute and commercialize VAZKEPA.
In addition, we received regulatory approval in Switzerland by the Swiss Agency for Therapeutic Products, or Swissmedic. VAZKEPA has been made available in Switzerland under individual reimbursement since January 2023.
We are responsible for supplying finished product to these partners. We continue to assess other potential partnership opportunities for VASCEPA with companies with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval.
Research and Development
Since its inception in 2011, the REDUCE-IT CV outcomes study of VASCEPA has been the centerpiece of our research and development. We also continue to study the potential mechanisms of action of the single active ingredient in VASCEPA, icosapent ethyl, or IPE. Based on the final positive results of REDUCE-IT, we sought additional indicated uses for VASCEPA in the U.S. and continue to pursue approval for VASCEPA around the world. We also anticipate continuing to publish additional details of the REDUCE-IT study to address scientific interest beyond the primary results of this study derived from the over 35,000 patient years of study experience which were accumulated in the REDUCE-IT study.
Based on REDUCE-IT results, as of the date of the filing of this Quarterly Report, more than 70 clinical treatment guidelines, consensus statements or scientific statements from global medical or scientific societies or within peer reviewed journals have recognized the use of icosapent ethyl, or IPE, in appropriate at-risk patients for CV risk reductions, including those statements which we were informed of by our global partners as well as guidelines which were newly received during the first quarter of 2026 as listed below:
30
In January 2026, at the LS2 Cardiovascular Research meeting in Bern, Switzerland, we provided support to global collaborators for a poster presentation from within the REDUCE-IT dataset as well as from in vitro data highlighting the potential anti-coagulant effects of IPE through suppression of tissue factor.
In March 2026, at the American College of Cardiology, or ACC, meeting in New Orleans, LA, USA, we provided support to global collaborators for two presentations, one poster and one oral. The poster presentation reported the inhibitory actions of EPA on the rate of Lipoprotein(a), or Lp(a), oxidation. The oral presentation looked at a secondary analysis of the REDUCE-IT dataset highlighting the efficacy of IPE among patients at extreme CV risk.
During the three months ended March 31, 2026, we and global medical and scientific collaborators supported a total of 6 publications inclusive of accepted abstracts, posters, and manuscripts.
Commercial and Clinical Supply
We manage the manufacturing and supply of VASCEPA and rely on contract manufacturers in each step of our commercial and clinical product supply chain. These steps include active pharmaceutical ingredient, or API, manufacturing, encapsulation of the API, product packaging and supply-related logistics. Our approach to product supply procurement is designed to mitigate risk of supply interruption and maintain an environment of cost competition through diversification of contract manufacturers at each stage of the supply chain and lack of reliance on any single supplier. We have multiple U.S. FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise in the U.S. We also have multiple international API suppliers, encapsulators and packagers to support the commercialization of VASCEPA in geographies where the drug is approved outside the U.S. Not all of our suppliers approved by the U.S. FDA are approved in every other geography. The regulatory process generally requires extensive details as part of the submission provided to a country or region in connection with a company's request for regulatory approval. Suppliers must be specifically identified as part of the submission for qualification and approval for commercialization in a country or region. As a result, only supply, as approved, may be used in finished goods available for sale in a specific country or region. The amount of supply we seek to purchase in future periods will depend on the level of growth of VASCEPA revenues and minimum purchase commitments with certain suppliers. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand. As of March 31, 2026, we had inventory of $183.6 million, of which 35% is inventory approved for use in North America.
31
Financial Operations Overview
Product revenue, net. All of our product revenue is derived from product sales of 1-gram and 0.5-gram size capsules of VASCEPA, net of allowances, discounts, incentives, rebates, chargebacks and returns. In the U.S., VASCEPA is sold to three major wholesalers, several regional wholesalers along with mail order pharmacy providers that in turn resell the product to retail pharmacies, as well as directly to select regional retail pharmacy chains, or collectively, our distributors or our customers. Most of these customers resell VASCEPA to retail pharmacies for purposes of dispensing VASCEPA to patients. Revenues from VASCEPA sales are recognized upon delivery to the distributor or customer. Timing of shipments to wholesalers, as used for revenue recognition, and timing of prescriptions as estimated by third-party sources such as Symphony Health may differ from period to period. Our product revenue, net included adjustment for co-pay mitigation rebates provided by us to commercially insured patients in the U.S.
Outside of the U.S., our product revenue is derived from the sales of VASCEPA to our commercial partners based on the net price for VASCEPA established in our contracts with such partners. These commercial partners then resell the product in their agreed commercial territory. Revenues from sales to our international commercial partners are recognized when the commercial partners obtain control of our product. The net price of VASCEPA sold by us to our customers where we directly sell VASCEPA is generally significantly higher than the net price of VASCEPA that we sell to commercial partners who then incur the cost of promoting and reselling the product in their territories. As a result, even when the net price of VASCEPA to patients is similar in various parts of the world, our gross margin on sales is higher where we sell VASCEPA directly.
Licensing and royalty revenue. Licensing and royalty revenue currently consists of revenue attributable to receipt of upfront, non-refundable payments, milestone payments and sales-based payments related to license and distribution agreements for VASCEPA outside the U.S. We recognize revenue from licensing arrangements as we fulfill the performance obligations under each of the agreements. As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners. The royalty payments are being recognized when the uncertainty related to the consideration is resolved.
Cost of goods sold. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, quality assurance, insurance, and other indirect manufacturing, logistics and product support costs. The cost of the API included in cost of goods sold reflects the average cost method of inventory valuation and relief. This average cost reflects the actual purchase price of VASCEPA API. Our cost of goods sold is not materially impacted by whether we sell VASCEPA directly in a country or we sell VASCEPA to a commercial partner for resale in a country.
Selling, general and administrative expense. Selling, general and administrative expense consists primarily of salaries and other related costs, including stock-based compensation expense, for personnel in our marketing, executive, business development, finance and information technology functions. Other costs primarily include facility costs and professional fees for accounting, consulting and legal services.
Research and development expense. Research and development expense consists primarily of fees paid to professional service providers in conjunction with independent monitoring of our clinical trials and acquiring and evaluating data in conjunction with our clinical trials, fees paid to independent researchers, costs of qualifying contract manufacturers, services expenses incurred in developing and testing products and product candidates, salaries and related expenses for personnel, including stock-based compensation expense, costs of materials, depreciation, rent, utilities and other facilities costs. In addition, research and development expenses include the cost to support current development efforts, costs of product supply received from suppliers when such receipt by us is prior to regulatory approval of the supplier, as well as license fees related to our strategic collaboration with Mochida. We expense research and development costs as incurred.
Restructuring expense. Restructuring expense consists of restructuring costs incurred under our June 2025 Global Restructuring Plan, which consists of severance pay, incentive compensation, insurance benefits, stock-based compensation and other contract related costs.
Interest income, net and other income (expense), net. Interest income, net consists primarily of interest earned on our cash and cash equivalents, as well as our short-term investments. Other income (expense), net, consists of foreign exchange losses and gains as well as sublease income.
Benefit from (provision for) income taxes. Income tax provision, deferred tax assets and liabilities, and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid. We are subject to income taxes in both the U.S. and foreign jurisdictions. In applying guidance prescribed under ASC 740 and based on present evidence and
32
conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for 2026 and 2025 are not more likely than not to be realized.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements and notes, which have been prepared in accordance with accounting principles generally accepted in the U.S., or GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. On an ongoing basis, estimates are assessed and adjusted based on historical experience and current market-specific indicators, environment and assumptions. Actual results may differ from these estimates under different assumptions or conditions. A summary of our critical accounting policies, significant judgments and estimates is presented in Part II, Item 7 of our Annual Report. There have been no material changes to our critical accounting policies, significant judgments and estimates described in our Annual Report.
Recent Accounting Pronouncements
For a discussion of recent accounting pronouncements, see Note 2—Significant Accounting Policies in the accompanying Notes to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
Effects of Inflation
We believe the impact of inflation on operations has been minimal during the past three years.
Results of Operations
Comparison of Three Months Ended March 31, 2026 and March 31, 2025
Total revenue, net. We recorded total revenue, net, of $45.1 million and $42.0 million during the three months ended March 31, 2026 and 2025, respectively, an increase of $3.1 million, or 7%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the U.S. In addition to the U.S., during the three months ending March 31, 2026, we also sold VASCEPA by prescription in certain countries outside of the U.S. through collaborations with third-party companies. As further discussed below, the aforementioned increase is due primarily to a $2.3 million increase in net product revenue outside of the U.S and a $0.8 million increase in licensing and royalty revenue.
Product revenue, net. We recorded product revenue, net, of $43.3 million and $41.0 million during the three months ended March 31, 2026 and 2025, respectively, an increase of $2.3 million, or 6%. This increase was due primarily to an increase in VASCEPA sales outside the U.S.
U.S. product revenue, net, remained consistent at $35.6 million during the three months ended March 31, 2026, compared to $35.7 million for the during the three months ended March 31, 2025.
The overall icosapent ethyl market in the U.S., based on prescription levels reported by Symphony Health, increased by 3% for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. Our share of the icosapent ethyl market has increased to approximately 48% in the three months ended March 31, 2026 compared to approximately 42% in the three months ended March 31, 2025. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions increased by 17% in the three months ended March 31, 2026 compared to the three months ended March 31, 2025.
In June 2025, we entered into a collaboration agreement with Recordati to commercialize VASCEPA in Europe. For the three months ended March 31, 2026, we recorded Europe product revenue, net, of $4.9 million compared to $5.4 million during the three months ended March 31, 2025, primarily due to the change in business structure within Europe.
For the three months ended March 31, 2026, we recorded RoW product revenue, net, of $2.8 million from our six other collaboration partners, comprising multiple distinct geographies, compared to a nominal amount during the three months ended March 31, 2025. The increase reflects normal variability across the multiple geographies encompassing this early stage of a developing ex-U.S. market.
Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. For the remainder of 2026, we will continue to (i) competitively manage our market leadership in the U.S., and (ii) drive expanded access and increased patient uptake of VASCEPA through ongoing support of our commercialization partners and their pricing, reimbursement and licensure initiatives in non-U.S. geographies around the world.
33
Licensing and royalty revenue. Licensing and royalty revenue during the three months ended March 31, 2026 and 2025 was $1.8 million and $1.0 million, respectively, an increase of $0.8 million, or 84%. This increase was primarily due to higher royalties as a result of moving to a partnering model in Europe as of June 2025 and an increase in partner sales within their respective territories.
As part of our licensing agreements with certain territories outside of the U.S., we are entitled to a percentage of revenue earned based on sales by our partners. Royalty payments are recognized based on revenue reported by our partners. The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and select partner sales within respective territories.
Cost of goods sold. Cost of goods sold during the three months ended March 31, 2026 and 2025 was $27.4 million and $16.9 million, respectively, an increase of $10.5 million, or 62%. This increase in cost of goods sold is due to increased product volumes. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API.
The API included in the calculation of the average cost of goods sold during the quarters ended March 31, 2026 and 2025 was sourced from multiple API suppliers. These suppliers compete with each other based on cost, consistent quality, capacity, timely delivery and other factors. In the future, we may see the average cost of supply change based on numerous potential factors including increased volume purchases, continued improvement in manufacturing efficiency, the mix of purchases made among suppliers, currency exchange rates and other factors. The average cost may be variable from period to period depending upon the timing and quantity of API purchased from each supplier.
Our overall gross margin on product sales for the three months ended March 31, 2026 and 2025 was 37% and 59%, respectively. The decrease in gross margin is primarily as a result of a change in customer mix.
Selling, general and administrative expense. Selling, general and administrative expense for the three months ended March 31, 2026 and 2025 was $21.1 million and $36.6 million, respectively, a decrease of $15.5 million, or 42%. Selling, general and administrative expenses for the three months ended March 31, 2026 and 2025 are summarized in the table below:
|
|
Three months ended March 31, |
|
|||||
In thousands |
|
2026 |
|
|
2025 |
|
||
Selling expense (1) |
|
$ |
3,888 |
|
|
$ |
16,921 |
|
General and administrative expense (2) |
|
|
15,497 |
|
|
|
16,124 |
|
Non-cash stock-based compensation expense (3) |
|
|
1,730 |
|
|
|
3,528 |
|
Total selling, general and administrative expense |
|
$ |
21,115 |
|
|
$ |
36,573 |
|
We will continue to manage our spending commitments to support our partners advancing commercialization and pricing and reimbursement efforts, as well as maintaining market leadership in the U.S.
34
Research and development expense. Research and development expense for the three months ended March 31, 2026 and 2025 was $4.7 million and $5.3 million, respectively, a decrease of $0.6 million, or 12%. Research and development expenses for the three months ended March 31, 2026 and 2025 are summarized in the table below:
|
|
Three months ended March 31, |
|
|||||
In thousands |
|
2026 |
|
|
2025 |
|
||
REDUCE-IT study and presentations (1) |
|
$ |
199 |
|
|
$ |
247 |
|
Regulatory filing fees and expenses (2) |
|
|
552 |
|
|
|
527 |
|
Non-clinical research activities (3) |
|
|
40 |
|
|
|
257 |
|
Internal staffing, overhead and other (4) |
|
|
3,309 |
|
|
|
3,482 |
|
Research and development expense, excluding non-cash expense |
|
|
4,100 |
|
|
|
4,513 |
|
Non-cash stock-based compensation expense (5) |
|
|
565 |
|
|
|
799 |
|
Total research and development expense |
|
$ |
4,665 |
|
|
$ |
5,312 |
|
We continuously evaluate all of our research and development investment commitments and priorities and are prepared to adjust such investment levels based on various factors, including the impact of U.S. generic competition, as well as timing of pricing reimbursements throughout the world.
Restructuring expense. Restructuring expense for the three months ended March 31, 2026 and 2025 was $3.3 million and nil, respectively. The charge in the current year is due to the implementation of the Global Restructuring Plan associated with the execution of the Recordati Licensing Agreement announced on June 24, 2025, which resulted in the elimination of commercial roles in the Company’s European operations. Refer to Note 2 Significant Accounting Policies for additional information.
Interest income, net. Interest income, net, for the three months ended March 31, 2026 and 2025 was $2.4 million and $2.9 million, respectively, a decrease of $0.4 million, or 16%. Interest income, net, represents income earned on cash and investment balances. The decrease is primarily due to lower interest rates in the current year period compared to the prior year period.
Other income, net. Other income, net, for the three months ended March 31, 2026 and 2025 was $0.2 million and $0.3 million, respectively, a decrease of $0.1 million, or 26%. Other income, net, primarily consists of gains and losses on foreign exchange transactions and sublease income related to our Bridgewater, New Jersey facility.
Provision for income taxes. Income tax provision for the three months ended March 31, 2026 and 2025 was $1.8 million and $2.1 million, respectively. The provision for the three months ended March 31, 2026 is the result of changes in income generated by our U.S. and foreign operations for which tax expense has been recognized based on a full-year estimated U.S. and foreign income tax liability.
35
Liquidity and Capital Resources
As of March 31, 2026, our aggregate sources of liquidity include cash and cash equivalents and restricted cash of $131.3 million and short-term investments of $176.8 million, aggregating $307.8 million. We have no indebtedness. Our cash and cash equivalents primarily include checking accounts and money market funds with original maturities of less than 90 days. Our short-term investments consist of securities that will be due in one year or less. We invest cash in excess of our immediate requirements in accordance with our investment policy, which limits the amounts we may invest in any one type of investment and requires all investments held by us to maintain minimum ratings from Nationally Recognized Statistical Rating Organizations so as to primarily achieve our goals of liquidity and capital preservation.
Our cash flows from operating, investing and financing activities, as reflected in the condensed consolidated statements of cash flows, are summarized in the following table:
|
|
Three months ended March 31, |
|
|||||
In millions |
|
2026 |
|
|
2025 |
|
||
Cash provided by (used in): |
|
|
|
|
|
|
||
Operating activities |
|
$ |
6.4 |
|
|
$ |
(12.5 |
) |
Investing activities |
|
|
(8.3 |
) |
|
|
12.1 |
|
Financing activities |
|
|
(1.7 |
) |
|
|
(1.1 |
) |
Decrease in cash and cash equivalents and restricted cash |
|
$ |
(3.6 |
) |
|
$ |
(1.5 |
) |
Net cash provided by operating activities increased during the three months ended March 31, 2026 as compared to the net cash used in operating activities during the same period in 2025. This is primarily driven by the Global Restructuring Plan and the resulting cost savings, including the elimination of commercial roles in our European operations.
Net cash used in investing activities during the three months ended March 31, 2026 decreased due primarily to the purchases of $50.8 million of investment grade interest-bearing instruments offset by proceeds from the maturity of $42.5 million in investment grade interest-bearing instruments as compared to the same period in 2025 where proceeds from the maturity of investment grade interest-bearing instruments were $55.0 million, partially offset by $42.9 million in purchases of investment-grade interest bearing instruments.
Net cash used in financing activities increased during the three months ended March 31, 2026 as compared to the same period in 2025 was as a result of taxes paid on stock-based awards.
On January 10, 2024, we 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 American Depository Shares, or ADS. We received shareholder and UK High Court approval of the share repurchase plan in April and May 2024, respectively. The share repurchase program has a five-year approval window and can be deployed at any point until the second quarter of 2029. The Company has not commenced any share repurchases to date, but we will continue to monitor business and market conditions.
As of March 31, 2026, we had net accounts receivable of $108.1 million and inventory of $183.6 million. We have incurred annual operating losses since our inception and, as a result, we had an accumulated deficit of $1.7 billion as of March 31, 2026.
As of March 31, 2026, we had cash and cash equivalents of $131.1 million and short-term investments of $176.8 million, aggregating $307.8 million. In accordance with ASC 205-40, management is required to evaluate our ability to continue as a going concern for at least one year after the date the financial statements are issued. We believe that our cash and cash equivalents and our short-term investments will be sufficient to fund our projected operations, including the share repurchase program if we were to decide to proceed with such, for at least one year from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report and is adequate to support continued operations based on our current plans. We have based this estimate on assumptions that may prove to be inaccurate, including as a result of the risks discussed under “Risk Factors” in this Quarterly Report and the Annual Report and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.
Contractual Obligations
Except for our contractual obligations related to purchase obligations with certain supply chain contracting parties and operating leases related to real estate used as office space as set forth in Note 5 – Commitments and Contingencies and Note 9 – Leases, respectively, in our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, there have been no material changes from the contractual obligations and commitments as of December 31, 2025 previously disclosed in our Annual Report on Form 10-K filed with the SEC on March 2, 2026.
We do not have any special purpose entities or other off-balance sheet arrangements.
36
Item 3. Quantitative and Qualitative Disclosures about Market Risk
There have been no material changes with respect to the information appearing in Part II, Item 7A “Quantitative and Qualitative Disclosures about Market Risk” of our Annual Report.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act), that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.
Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026. Based on such evaluation, our principal executive officer and principal financial officer have concluded that as of March 31, 2026, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
During the quarter ended March 31, 2026, there were no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
37
PART II
Item 1. Legal Proceedings
In the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. Refer to Note 5 – Commitments and Contingencies in this Quarterly Report for any legal proceedings that became reportable during the three months ended March 31, 2026, and updates to any descriptions of previously reported legal proceedings in which there have been material developments during such period. The discussion of legal proceedings included within Note 5 – Commitments and Contingencies is incorporated into this Item 1 by reference.
Item 1A. Risk Factors
This Quarterly Report on Form 10-Q contains forward-looking information based on our current expectations. Because our actual results may differ materially from any forward-looking statements that we make or that are made on our behalf, this section includes a discussion of important factors that could affect our actual future results, including, but not limited to, our ability to successfully commercialize VASCEPA and VAZKEPA, collectively referred to as VASCEPA, our capital resources, the progress and timing of our clinical programs, the safety and efficacy of our product candidates, risks associated with regulatory filings, the potential clinical benefits and market potential of our product candidates, commercial market estimates, future development efforts, patent protection, effects of healthcare reform, reliance on third parties effects of tax reform, and other risks set forth below.
There have been no material changes to the risk factors presented under Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2025. See Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2025 for a detailed discussion of risk factors affecting the Company.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer Purchases of Equity Securities
ADSs purchased in the first quarter of 2026 are as follows:
Period |
|
Total Number of |
|
|
Average Price |
|
||
January 1 - 31, 2026 |
|
|
113,490 |
|
|
$ |
14.57 |
|
February 1 - 28, 2026 |
|
|
1,423 |
|
|
|
14.92 |
|
March 1 - 31, 2026 |
|
|
965 |
|
|
|
13.80 |
|
Total |
|
|
115,878 |
|
|
$ |
14.57 |
|
(1) Represents ADSs withheld to satisfy tax withholding amounts due from employees related to the receipt of ADS which resulted from the exercise or vesting of equity awards.
Item 5. Other Information
38
Item 6. Exhibits
The following exhibits are incorporated by reference or filed or furnished as part of this report.
Exhibit |
|
Description |
|
Incorporated by Reference Herein |
||
|
Form |
|
Date |
|||
|
|
|
|
|
|
|
10.1 |
|
Non-Employee Director Compensation Policy |
|
Current Report on Form 8-K as Exhibit 10.1 |
|
March 27, 2026 |
|
|
|
|
|
|
|
31.1 |
|
Certification of President and Chief Executive Officer (Principal Executive Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
Filed herewith |
|
|
|
|
|
|
|
|
|
31.2 |
|
Certification of Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
Filed herewith |
|
|
|
|
|
|
|
|
|
32.1 |
|
Certification of President and Chief Executive Officer (Principal Executive Officer) and Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
Filed herewith |
|
|
|
|
|
|
|
|
|
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
|
Filed herewith |
|
|
|
|
|
|
|
|
|
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
Filed herewith |
|
|
|
|
|
|
|
|
|
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
Filed herewith |
|
|
|
|
|
|
|
|
|
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
Filed herewith |
|
|
|
|
|
|
|
|
|
101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
|
Filed herewith |
|
|
|
|
|
|
|
|
|
104 |
|
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*) |
|
Filed herewith |
|
|
39
SIGNATURE
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
AMARIN CORPORATION PLC |
||
|
|
|
By: |
|
/s/ Aaron Berg |
|
|
Aaron Berg |
|
|
|
|
|
President and Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
|
(On behalf of the Registrant) |
Date: April 29, 2026
AMARIN CORPORATION PLC |
||
|
|
|
By: |
|
/s/ Peter Fishman |
|
|
Peter Fishman |
|
|
|
|
|
Senior Vice President and Chief Financial Officer |
|
|
(Principal Financial and Accounting Officer) |
|
|
(On behalf of the Registrant) |
Date: April 29, 2026
40