Amarin Corporation(AMRN) - 2025 Q1 - Quarterly Report

PART I – Financial Information Item 1. Financial Statements The company's unaudited financial statements for Q1 2025 reflect decreased assets and revenue, a wider net loss, and continued cash usage in operations Condensed Consolidated Balance Sheets Total assets decreased to $655.7 million, driven by reductions in cash, investments, receivables, and inventory Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total current assets | $573,061 | $595,399 | | TOTAL ASSETS | $655,677 | $685,349 | | Total current liabilities | $162,408 | $179,949 | | Total liabilities | $181,990 | $199,173 | | Total stockholders' equity | $473,687 | $486,176 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $655,677 | $685,349 | Condensed Consolidated Statements of Operations Net revenue for Q1 2025 declined to $42.0 million, resulting in an increased operating loss of $16.8 million and a net loss of $15.7 million Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Total revenue, net | $42,017 | $56,519 | | Gross margin | $25,130 | $31,904 | | Total operating expenses | $41,885 | $45,487 | | Operating loss | $(16,755) | $(13,583) | | Net loss | $(15,697) | $(9,953) | | Basic and Diluted Loss per share | $(0.04) | $(0.02) | Condensed Consolidated Statements of Cash Flows Net cash used in operations was $12.5 million, while the end-of-period cash balance decreased significantly year-over-year to $119.8 million Condensed Consolidated Statements of Cash Flows (in thousands) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,459) | $(12,601) | | Net cash provided by investing activities | $12,064 | $28,719 | | Net cash used in financing activities | $(1,119) | $(1,426) | | Net (decrease) increase in cash | $(1,514) | $14,692 | | Cash, cash equivalents and restricted cash, end of period | $119,824 | $214,469 | Notes to Condensed Consolidated Financial Statements The notes disclose significant U.S. generic competition, high customer concentration, ongoing legal proceedings, and future purchase obligations - The company faces significant competition in the U.S. from multiple generic versions of icosapent ethyl following an adverse patent ruling in March 2020[21] - Three major customers accounted for 91% of gross product sales in Q1 2025, indicating significant customer concentration[46] - Amarin is involved in multiple legal proceedings, including antitrust class action lawsuits and a DOJ investigation into its promotional programs[71][72][74] - The company has $61.2 million in future contractual purchase obligations, with an additional $152.8 million contingent on European regulatory and pricing approvals[83] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management attributes the 26% revenue decline to U.S. generic competition, while highlighting European growth, improved gross margin, and sufficient liquidity Overview The company's strategy focuses on expanding European commercialization and international partnerships to offset significant generic competition in the U.S - Multiple generic versions of icosapent ethyl have entered the U.S. market following a 2020 court ruling that invalidated several key patents[146][147] - The company is expanding its global footprint through partnerships with Edding in China, HLS in Canada, and CSL Seqirus in Australia/New Zealand[160][162] European Commercial Launch Status | Country | National Reimbursement | Product Availability | Launch Date | | :--- | :--- | :--- | :--- | | Sweden | March 2022 | March 2022 | March 2022 | | England/Wales | July 2022 | October 2022 | October 2022 | | Spain | July 2023 | September 2023 | September 2023 | | Netherlands | August 2023 | September 2023 | September 2023 | | Italy | December 2024 | December 2024 | January 2025 | Results of Operations Q1 2025 revenue fell 26% to $42.0 million, driven by a sharp decline in U.S. sales that was partially offset by strong European growth - The decrease in U.S. revenue was driven by lower net selling prices and reduced volume due to generic competition and loss of exclusive PBM coverage[184][185] - The company's share of the U.S. icosapent ethyl market decreased from approximately 56% in Q1 2024 to 42% in Q1 2025[186] - Gross margin on product sales increased to 59% in Q1 2025 from 55% in Q1 2024, primarily due to a change in customer mix[193] Revenue Comparison (in millions) | Revenue Type | Q1 2025 | Q1 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | U.S. Product Revenue | $35.7 | $48.1 | $(12.4) | -26% | | Europe Product Revenue | $5.4 | $1.9 | $3.5 | +184% | | RoW Product Revenue | ~$0.0 | $5.2 | $(5.2) | -100% | | Licensing & Royalty | $1.0 | $1.4 | $(0.4) | -28% | | Total Revenue, net | $42.0 | $56.5 | $(14.5) | -26% | Liquidity and Capital Resources The company maintains $282.1 million in total liquidity with no debt and believes its capital is sufficient to fund operations for at least one year - Management has concluded that its cash and investments are adequate to support continued operations for at least one year from the financial statement issuance date[208] - A share repurchase program of up to $50.0 million was approved in May 2024, but no repurchases have commenced to date[206] Key Liquidity Data (as of March 31, 2025) | Metric | Amount (in millions) | | :--- | :--- | | Cash, cash equivalents and restricted cash | $119.8 | | Short-term investments | $162.3 | | Aggregate Liquidity | $282.1 | | Indebtedness | $0 | Item 3. Quantitative and Qualitative Disclosures about Market Risk There have been no material changes to the company's market risk disclosures since its 2024 Annual Report - There have been no material changes with respect to market risk disclosures from the company's 2024 Annual Report[210] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of the end of the quarter - The principal executive and financial officers concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[213] - No material changes occurred during the quarter that are reasonably likely to materially affect the company's internal control over financial reporting[214] PART II – Other Information Item 1. Legal Proceedings This section incorporates by reference the detailed discussion of legal matters found in Note 5 of the financial statements - Information regarding legal proceedings is detailed in Note 5 – Commitments and Contingencies and is incorporated by reference into this section[216] Item 1A. Risk Factors Key risks include potential Nasdaq delisting due to minimum bid price requirements and adverse effects from global trade sanctions - A key risk is the potential delisting of the company's ADSs from Nasdaq if the $1.00 minimum bid price is not maintained[219] - The company's business may be adversely affected by tariffs, trade sanctions, or similar government actions[221][222] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company withheld 90,267 ADSs during the quarter to satisfy employee tax obligations related to equity awards Issuer Purchases of Equity Securities (Q1 2025) | Period | Total Number of ADSs Purchased | Average Price Paid per ADS | | :--- | :--- | :--- | | January 1 - 31, 2025 | 87,233 | $12.40 | | February 1 - 28, 2025 | 872 | $12.40 | | March 1 - 31, 2025 | 2,162 | $12.40 | | Total | 90,267 | $12.40 | Item 5. Other Information No officers or directors adopted, modified, or terminated Rule 10b5-1 trading arrangements during the first quarter of 2025 - No officers or directors engaged in the adoption, modification, or termination of Rule 10b5-1 or non-Rule 10b5-1 trading arrangements in Q1 2025[224] Item 6. Exhibits This section lists all exhibits filed with the report, including Sarbanes-Oxley certifications and an amended Depositary Agreement - Exhibits filed with the report include Sarbanes-Oxley Act certifications (31.1, 31.2, 32.1) and an amendment to the Depositary Agreement (4.1)[227]