Amarin Corporation(AMRN) - 2024 Q1 - Quarterly Results

Executive Summary & Q1 2024 Highlights Amarin achieved key Q1 2024 milestones, including a VAZKEPA patent extension, strong European sales, stable U.S. market leadership, and a $50 million share repurchase approval, despite a 34% revenue decrease Key Business Updates Amarin achieved significant progress in Q1 2024, including securing a VAZKEPA patent in Europe extending protection until 2039, driving substantial in-market sales growth in Europe, maintaining IPE market leadership in the U.S. with significant profit, and advancing Rest of World partnerships - A new VAZKEPA® patent was issued by the European Patent Office, extending intellectual property protection in Europe until 2039[1][2][3] - Europe saw approximately 65% in-market sales growth in Q1 2024 versus Q4 2023, driven by Spain and the U.K.[1][2][3] - A share repurchase program of up to $50 million was approved by shareholders, with repurchases expected to commence following UK High Court approval in Q2 2024[1][2] Financial Snapshot Total net revenue for Q1 2024 decreased by 34% year-over-year, primarily due to generic competition in the U.S., while the company's cash position remained stable at $308 million Q1 2024 Financial Snapshot | Metric | Q1 2024 (Millions) | Q1 2023 (Millions) | Change (%) | | :----------------- | :----------------- | :----------------- | :--------- | | Total Net Revenue | $56.5 | $86.0 | -34% | | Current Cash Position | $308 | N/A | Stable | Regional Business Performance Amarin demonstrated varied regional performance in Q1 2024, with strong European sales growth and patent protection, U.S. market leadership despite revenue decline, and commercial progress in Rest of World markets Europe Amarin secured a new VAZKEPA® patent extending exclusivity until 2039 and achieved significant in-market sales growth of approximately 65% in Q1 2024 versus Q4 2023, led by strong patient uptake in Spain (+91%) and the U.K. (+28%) - Received a Decision to Grant from the European Patent Office (EPO) for a new patent covering VAZKEPA®, extending exclusivity until 2039[3] Europe In-Market Sales & Patient Growth (Q1 2024 vs Q4 2023) | Metric | Growth (Q1 '24 vs Q4 '23) | | :---------------------- | :------------------------ | | In-market sales growth | ~65% | | Spain patients on therapy | ~91% | | U.K. patients on therapy | ~28% | - Progress on pricing and reimbursement in Italy (resubmitted dossier), France (on-track to submit strengthened dossier in 2024), Germany (continued work on resubmission), and expected outcomes in Greece and Portugal[4] United States Amarin maintained IPE market leadership in the U.S. with stable market share for six consecutive quarters, generating significant profit, however, U.S. product net revenue declined by 41% year-over-year in Q1 2024, primarily due to reduced net selling price from generic competition - Maintained IPE market leadership with 50%+ of the total market in exclusive accounts, and market share remained stable for six consecutive quarters[5] U.S. Product Net Revenue (Q1 2024 vs Q1 2023) | Metric | Q1 2024 (Millions) | Q1 2023 (Millions) | Change (%) | | :--------------------- | :----------------- | :----------------- | :--------- | | U.S. Product Net Revenue | $48.1 | $82.3 | -41% | - The decrease in U.S. revenue was primarily driven by a reduction in net selling price due to generic competition[2][5] Rest of World (RoW) Amarin and its partners are making commercial, market access, and regulatory progress in key RoW territories, with China seeing 100% sales growth in Q1 2024 versus Q4 2023, Canada securing public access in British Columbia, and Australia's reimbursement submission remaining on-track - In China, partner Edding achieved 100% sales growth in Q1 2024 versus Q4 2023, with the cardiovascular risk reduction indication filing on-track[6] - In Canada, partner HLS secured public access for VASCEPA in British Columbia, paving the way for the private market[6] - In Australia, partner CSL Seqirus continues to advance the submission for VAZKEPA reimbursement with local health authorities[6] Research & Development / Medical Affairs Five data abstracts focused on VASCEPA/VAZKEPA's role in reducing cardiovascular events were presented at the American College of Cardiology's Annual Scientific Session & Expo in April 2024 - Five supported data abstracts focused on advancing the medical community's understanding of VASCEPA/VAZKEPA to reduce cardiovascular events were presented at the American College of Cardiology's Annual Scientific Session & Expo[7] Financial Results for Q1 2024 Amarin's Q1 2024 financial results show a 34% year-over-year revenue decrease due to U.S. generic competition, improved GAAP net loss, and stable cash position, supported by significant operating expense reductions Revenue Performance Total net revenue for Q1 2024 decreased by 34% year-over-year to $56.5 million, primarily driven by a 35% decrease in net product revenue due to U.S. generic competition, while licensing and royalty revenue remained stable Q1 2024 Revenue Performance (in thousands) | Metric | Q1 2024 | Q1 2023 | Change (%) | | :-------------------------- | :------- | :------- | :--------- | | Total Net Revenue | $56,519 | $85,975 | -34% | | Net Product Revenue | $55,156 | $84,654 | -35% | | U.S. Net Product Revenue | $48,100 | $82,300 | -41.5% | | European Net Product Revenue | $1,900 | N/A | N/A | | RoW Net Product Revenue | $5,200 | N/A | N/A | | Licensing & Royalty Revenue | $1,363 | $1,321 | +3.2% | - The decrease in total net revenue and net product revenue was primarily driven by an impact in net selling price due to US generic competition[8] Operating Expenses & Gross Margin Cost of goods sold decreased, contributing to a 55% overall gross margin on net product revenue (70% excluding a Q1 2023 restructuring charge), selling, general and administrative expenses significantly decreased by 33% due to a July 2023 organizational restructuring plan, while R&D expenses remained stable Q1 2024 Operating Expenses & Gross Margin (in thousands) | Metric | Q1 2024 | Q1 2023 | Change (%) | | :----------------------------------- | :------- | :------- | :--------- | | Cost of Goods Sold | $24,615 | $38,048 | -35.3% | | Gross Margin on Net Product Revenue | 55% | 55% | 0% | | (Excluding Q1 2023 restructuring charge) | 70% | N/A | N/A | | Selling, General & Administrative Expenses | $39,889 | $59,587 | -33.1% | | Research & Development Expenses | $5,598 | $5,681 | -1.5% | - The decrease in Selling, General and Administrative expenses was primarily due to the organization restructuring plan enacted in July 2023[10] Net Loss & EPS (GAAP & Non-GAAP) Amarin reported a GAAP net loss of $10.0 million for Q1 2024, an improvement from $16.5 million in Q1 2023, basic and diluted loss per share was $0.02, and on a non-GAAP adjusted basis, the net loss was $4.7 million, compared to a net income of $7.6 million in the prior year, with adjusted loss per share of $0.01 Q1 2024 Net Loss & EPS (in thousands, except per share amounts) | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :-------------------------- | :------- | :------- | :----------- | | GAAP Net Loss | $(9,953) | $(16,460)| +39.6% | | GAAP Basic & Diluted Loss per Share | $(0.02) | $(0.04) | +50% | | Non-GAAP Adjusted Net (Loss) Income | $(4,735) | $7,621 | -162.1% | | Non-GAAP Adjusted Basic & Diluted (Loss) Earnings per Share | $(0.01) | $0.02 | -150% | - GAAP net loss for Q1 2024 includes $5.2 million in non-cash stock-based compensation[11] Cash Position As of March 31, 2024, Amarin reported aggregate cash and investments of $308.2 million, maintaining stability over seven quarters Aggregate Cash and Investments | Metric | As of March 31, 2024 (Millions) | | :-------------------------- | :------------------------------ | | Aggregate Cash & Investments | $308.2 | - The cash position has remained stable over seven quarters[1] 2024 Financial Outlook Amarin is on track to achieve $40 million in annual savings from its July 2023 reduction in force, and the company reiterates its confidence that current cash and investments are sufficient to support continued operations, including the share repurchase program, with a continued focus on cash preservation and value-additive investments - On track to deliver $40 million of annual savings based on the reduction in force announced in July 2023[12] - Current cash and investments and other assets are adequate to support continued operations, including the share repurchase program[12] Share Repurchase Program Details The implementation of the $50 million share repurchase program is conditional upon UK court approval, expected by the end of Q2 2024, following shareholder approval, repurchases will be funded from distributable profits using existing cash resources and will comply with U.S. securities laws - Shareholders approved the capital reduction necessary to fund the share repurchase program at the annual general meeting on April 18, 2024[22] - UK court approval is anticipated by the end of the second quarter of 2024, with share repurchases commencing shortly thereafter[22] - The repurchases will be funded out of distributable profits utilizing the Company's existing cash resources and will conclude once $50 million of ADSs have been purchased[22] Company & Product Information Amarin is an innovative pharmaceutical company focused on cardiovascular disease management, with its flagship product, VASCEPA/VAZKEPA, approved for reducing cardiovascular events and severe hypertriglyceridemia globally About Amarin Amarin is an innovative pharmaceutical company focused on cardiovascular disease management, committed to advancing the understanding and treatment of persistent cardiovascular risk globally, with offices in the U.S., Ireland, Switzerland, and other European countries - Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management[14] - Committed to increasing scientific understanding and advancing treatment of cardiovascular risk for patients worldwide[14] About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules VASCEPA/VAZKEPA (icosapent ethyl) capsules are the first FDA-approved prescription treatment comprised solely of IPE, indicated for reducing cardiovascular events in high-risk patients on statin therapy and for severe hypertriglyceridemia, it has been prescribed over twenty million times and is approved and sold in multiple countries globally - VASCEPA is the first prescription treatment approved by the U.S. FDA comprised solely of icosapent ethyl (IPE)[16] - Approved by the U.S. FDA in January 2020 for reducing cardiovascular events in high-risk patients on statin therapy, and initially in 2013 for severe hypertriglyceridemia[16] - VASCEPA has been prescribed more than twenty million times and is approved and sold in the U.S., Canada, China, Lebanon, UAE, and in Europe (VAZKEPA) in Sweden, Denmark, Finland, Austria, the UK, Spain, and the Netherlands[16] Product Indications & Safety Information This section details VASCEPA's U.S. indications for reducing cardiovascular events and severe hypertriglyceridemia, along with important safety information regarding contraindications and adverse reactions United States Indications and Limitation of Use VASCEPA is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of major cardiovascular events in adult patients with elevated triglyceride levels and established cardiovascular disease or diabetes mellitus with additional risk factors, it is also indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia - Indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus with two or more additional risk factors[17] - Indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia[17] Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity, it is associated with increased risks of atrial fibrillation or atrial flutter requiring hospitalization (3% vs 2%) and bleeding (12% vs 10%), especially with concomitant antithrombotic medications, common adverse reactions include musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation - Contraindicated in patients with known hypersensitivity to VASCEPA or any of its components[18] - Associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization (3% vs 2%) and bleeding (12% vs 10%), particularly in patients receiving concomitant antithrombotic medications[18] - Common adverse reactions (incidence ≥3% and ≥1% more frequent than placebo) include musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%)[19] Europe Product Information For detailed product information regarding VAZKEPA® in Europe, refer to the Summary of Product Characteristics (SmPC) available on medicines.org.uk/emc - Further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe is available at https://www.medicines.org.uk/emc/product/12964/smpc[21](index=21&type=chunk) Non-GAAP Financial Measures This press release includes non-GAAP adjusted financial information, which management uses for internal reporting, forecasting, performance evaluation, and executive compensation, these measures provide a better understanding of core business operations but should be considered in addition to, not as a substitute for, GAAP financial performance measures, as they have limitations and may differ from measures used by other companies - Non-GAAP adjusted net (loss) income is derived by adjusting GAAP net loss for non-cash stock-based compensation expense, restructuring expense, and other one-time expenses[24] - Management uses these non-GAAP measures for internal reporting, forecasting, public business outlook, performance evaluation, and executive compensation[24] - Investors are reminded to consider non-GAAP measures in addition to, and not as a substitute for, GAAP financial performance measures, as they have limitations and may differ from those used by other companies[25] Forward-Looking Statements & Disclaimers This section outlines the forward-looking nature of statements in the press release, emphasizing inherent risks and uncertainties, and clarifies Amarin's communication channels for material information Forward-Looking Statements This press release contains forward-looking statements subject to risks and uncertainties, including those related to Amarin's achievements, financial outlook, global market expansion, and product success, investors are cautioned not to place undue reliance on these statements, and Amarin undertakes no obligation to update them - Contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[26] - These statements are not promises or guarantees and involve substantial risks and uncertainties, as detailed in Amarin's SEC filings[26] - Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements[26] Availability of Other Information About Amarin Amarin communicates material information to investors and the public via its company website, investor relations website (including presentations and FAQs), SEC filings, press releases, public conference calls, and webcasts, investors are encouraged to regularly review these channels - Amarin communicates with investors and the public using its company website (www.amarincorp.com), investor relations website (www.amarincorp.com/investor-relations), SEC filings, press releases, public conference calls, and webcasts[28] - Information posted on these channels could be deemed material information, and investors are encouraged to review them regularly[28] Financial Statements This section provides Amarin's consolidated balance sheet data, statements of operations, and a reconciliation of GAAP to non-GAAP net income (loss) for Q1 2024 and prior periods Consolidated Balance Sheet Data The consolidated balance sheet data presents Amarin's financial position as of March 31, 2024, and December 31, 2023, detailing assets, liabilities, and stockholders' equity Consolidated Balance Sheet Data (in thousands) | | March 31, 2024 | December 31, 2023 | | :------------------------------------------------------- | :------------- | :---------------- | | ASSETS | | | | Current Assets: | | | | Cash and cash equivalents | $213,944 | $199,252 | | Short-term investments | $94,235 | $121,407 | | Accounts receivable, net | $115,806 | $133,563 | | Inventory | $255,280 | $258,616 | | Total current assets | $687,932 | $724,981 | | TOTAL ASSETS | $790,013 | $831,684 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Current Liabilities: | | | | Accounts payable | $67,600 | $52,762 | | Accrued expenses and other current liabilities | $154,440 | $204,174 | | Total current liabilities | $224,381 | $259,277 | | Total liabilities | $244,077 | $279,587 | | Stockholders' Equity: | | | | Total stockholders' equity | $545,936 | $552,097 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $790,013 | $831,684 | Consolidated Statements of Operations Data The consolidated statements of operations data provides a breakdown of revenues, cost of goods sold, operating expenses, and net loss for the three months ended March 31, 2024, and 2023 Consolidated Statements of Operations Data (in thousands, except per share amounts) | | Three months ended March 31, 2024 | Three months ended March 31, 2023 | | :----------------------------------------------------------- | :-------------------------------- | :-------------------------------- | | Product revenue, net | $55,156 | $84,654 | | Licensing and royalty revenue | $1,363 | $1,321 | | Total revenue, net | $56,519 | $85,975 | | Less: Cost of goods sold | $24,615 | $25,794 | | Less: Cost of goods sold - restructuring inventory | — | $12,254 | | Gross margin | $31,904 | $47,927 | | Operating expenses: | | | | Selling, general and administrative | $39,889 | $59,587 | | Research and development | $5,598 | $5,681 | | Total operating expenses | $45,487 | $65,268 | | Operating loss | $(13,583) | $(17,341) | | Net loss | $(9,953) | $(16,460) | | Loss per share: | | | | Basic | $(0.02) | $(0.04) | | Diluted | $(0.02) | $(0.04) | Reconciliation of Non-GAAP Net Income (Loss) This section provides a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) for the three months ended March 31, 2024, and 2023, adjusting for non-cash stock-based compensation expense, restructuring inventory, and advisor fees Reconciliation of Non-GAAP Net Income (Loss) (in thousands, except per share amounts) | | 2024 | 2023 | | :-------------------------------------------------------------- | :-------- | :-------- | | Net loss for EPS - GAAP | $(9,953) | $(16,460) | | Non-cash stock-based compensation expense | $5,218 | $5,557 | | Restructuring inventory | — | $12,254 | | Advisor fees | — | $6,270 | | Adjusted net (loss) income for EPS - non-GAAP | $(4,735) | $7,621 | | (Loss) earnings per share: | | | | Basic - non-GAAP | $(0.01) | $0.02 | | Diluted - non-GAAP | $(0.01) | $0.02 |