ALKS-2680

— First Quarter Revenues of $306.5 Million — — GAAP Net Income of $22.5 Million and Diluted GAAP Earnings per Share of $0.13 — — Company Reiterates 2025 Financial Expectations — DUBLIN , May 1, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the first quarter of 2025. "Our first quarter financial performance provides a solid foundation to deliver on our financial guidance for the year. We are in a strong position in this dynamic macroeconomic environment and remain focused on executing on the strategic objectives that we believe will drive the future value of the company," said Richard Pops , Chief Executive Officer of Alkermes. "We recently achieved an important milestone in the program for ALKS 2680, our novel, investigational, oral orexin 2 receptor agonist, completing enrollment in our first phase 2 study in the program, Vibrance-1, in narcolepsy type 1. We now expect topline results from Vibrance-1 early in the third quarter. We expect to complete enrollment in the Vibrance-2 phase 2 study, in narcolepsy type 2, mid-year, with topline data from that study expected in the fall. Enrollment in Vibrance-3, our phase 2 study in idiopathic hypersomnia, is now also underway. Across the ALKS 2680 development program, we have strong momentum and are preparing for the phase 3 program. With the potential to transform the treatment of central disorders of hypersomnolence, orexin 2 receptor agonists are one of the most exciting new therapeutic categories in development." Key Financial Highlights Revenues (In millions) Three Months Ended March 31 , 2025 2024 Total Revenues $ 306.5 $ 350.4 Total Proprietary Net Sales $ 244.5 $ 233.5 VIVITROL® $ 101.0 $ 97.7 ARISTADA®i $ 73.5 $ 78.9 LYBALVI® $ 70.0 $ 57.0 Profitability (In millions) Three Months Ended March 31 , 2025 2024 GAAP Net Income From Continuing Operations $ 22.5 $ 38.9 GAAP Net Income (Loss) From Discontinued Operations $ -- $ (2.1) GAAP Net Income $ 22.5 $ 36.8 EBITDA From Continuing Operations $ 22.8 $ 51.5 EBITDA From Discontinued Operations $ -- $ (2.5) EBITDA $ 22.8 $ 49.0 Adjusted EBITDA $ 45.6 $ 81.8 Revenue Highlights LYBALVI Revenues for the quarter were $70.0 million . Revenues and total prescriptions for the quarter grew 23% and 22%, respectively, compared to the first quarter of 2024. ARISTADAi Revenues for the quarter were $73.5 million . VIVITROL Revenues for the quarter were $101.0 million . Manufacturing & Royalty Revenues VUMERITY® manufacturing and royalty revenues for the quarter were $27.8 million . Royalty revenues from XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $17.7 million . Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. (In millions) Three Months Ended March 31 , 2025 2024 R&D Expense – Continuing Operations $ 71.8 $ 67.6 R&D Expense – Discontinued Operations $ -- $ 2.5 SG&A Expense – Continuing Operations $ 171.7 $ 179.7 SG&A Expense – Discontinued Operations $ -- $ -- Balance Sheet At March 31, 2025 , the company recorded cash, cash equivalents and total investments of $916.2 million , compared to $824.8 million at Dec. 31, 2024. Financial Expectations for 2025Alkermes reiterates its financial expectations for 2025, as set forth in its press release dated Feb. 12, 2025 . Notes and Explanations1. The company determined that upon the separation of its former oncology business, completed on Nov. 15, 2023 , the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three months ended March 31, 2024 . Conference CallAlkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET ( 1:00 p.m. BST ) on Thursday, May 1, 2025 , to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland , Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio . For more information, please visit Alkermes' website at www.alkermes.com. Non-GAAP Financial MeasuresThis press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including EBITDA and Adjusted EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. EBITDA represents earnings before interest, tax, depreciation and amortization. Adjusted EBITDA excludes share-based compensation expense in addition to the components of EBITDA from earnings. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, EBITDA and Adjusted EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, EBITDA and Adjusted EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking StatementsCertain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning its future financial and operating performance, business plans or prospects, including expected value drivers; and the company's expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations; clinical development activities may not be completed on time or at all; the results of the company's development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may not agree with the company's regulatory approval strategies or may make adverse decisions regarding the company's products; the unfavorable outcome of arbitration, litigation, or other proceedings or disputes related to the company's products or products using the company's proprietary technologies; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to government payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2024 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc. ; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited , used by Alkermes, Inc. under license; BYANNLI®, INVEGA HAFYERA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc. , used by Alkermes under license. ________________________________ i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. Alkermes plc and Subsidiaries Selected Financial Information (Unaudited) Condensed Consolidated Statements of Operations - GAAP Three Months Ended Three Months Ended (In thousands, except per share data) March 31, 2025 March 31, 2024 Revenues: Product sales, net $ 244,493 $ 233,536 Manufacturing and royalty revenues 62,017 116,833 Research and development revenue — 3 Total Revenues 306,510 350,372 Expenses: Cost of goods manufactured and sold 49,197 58,644 Research and development 71,817 67,611 Selling, general and administrative 171,704 179,749 Amortization of acquired intangible assets — 1,059 Total Expenses 292,718 307,063 Operating Income 13,792 43,309 Other Income, net: Interest income 10,141 9,399 Interest expense — (5,978) Other income, net 1,556 182 Total Other Income, net 11,697 3,603 Income Before Income Taxes 25,489 46,912 Income Tax Provision 3,025 7,964 Net Income From Continuing Operations 22,464 38,948 Loss from Discontinued Operations — Net of Tax — (2,120) Net Income — GAAP $ 22,464 $ 36,828 GAAP Earnings (Loss) Per Share - Basic: From continuing operations $ 0.14 $ 0.23 From discontinued operations — (0.01) Earnings per share $ 0.14 $ 0.22 GAAP Earnings (Loss) Per Share - Diluted: From continuing operations $ 0.13 $ 0.23 From discontinued operations — (0.01) Earnings per share $ 0.13 $ 0.21 Weighted Average Number of Ordinary Shares Outstanding: Basic — GAAP 163,407 167,984 Diluted — GAAP 168,737 172,981 Condensed Consolidated Statements of Operations - GAAP (Continued) Three Months Ended Three Months Ended (In thousands, except per share data) March 31, 2025 March 31, 2024 An itemized reconciliation between net income from continuing operations on a GAAP basis and Adjusted EBITDA is as follows: Net Income from Continuing Operations $ 22,464 $ 38,948 Adjustments: Depreciation and amortization expense 7,421 8,056 Interest income (10,141) (9,399) Interest expense — 5,978 Income tax provision 3,025 7,964 EBITDA from Continuing Operations 22,769 51,547 EBITDA from Discontinued Operations — (2,516) EBITDA 22,769 49,031 Share-based compensation 22,810 32,755 Adjusted EBITDA $ 45,579 $ 81,786 Alkermes plc and Subsidiaries Selected Financial Information (Unaudited) Condensed Consolidated Balance Sheets March 31 , December 31 , (In thousands) 2025 2024 Cash, cash equivalents and total investments $ 916,206 $ 824,816 Receivables 318,703 389,733 Inventory 183,438 182,887 Contract assets 3,049 4,990 Prepaid expenses and other current assets 89,843 86,077 Property, plant and equipment, net 233,920 227,564 Intangible assets, net and goodwill 83,899 83,917 Deferred tax assets 152,144 154,835 Other assets 100,775 100,748 Total Assets $ 2,081,977 $ 2,055,567 Accrued sales discounts, allowances and reserves $ 249,795 $ 272,452 Other current liabilities 193,935 192,747 Other long-term liabilities 126,664 125,391 Total shareholders' equity 1,511,583 1,464,977 Total Liabilities and Shareholders' Equity $ 2,081,977 $ 2,055,567 Ordinary shares outstanding (in thousands) 164,853 162,177 This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 , which the company intends to file in May 2025 . Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 View original content to download multimedia:https://www.prnewswire.com/news-releases/alkermes-plc-reports-first-quarter-2025-financial-results-302443339.html SOURCE Alkermes plc

DUBLIN, April 1, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the initiation of Vibrance-3, a phase 2 clinical study evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with idiopathic hypersomnia (IH). ALKS 2680 is the company's novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy type 1, narcolepsy type 2 and IH – chronic, neurological disorders characterized by excessive daytime sleepiness. "The initiation of Vibrance-3 represents an important step forward for the ALKS 2680 development program as we seek to advance a potential new treatment option for people living with idiopathic hypersomnia. There remains high unmet need for the idiopathic hypersomnia community, as evidenced by a recent survey conducted by the Sleep Consortium1 in which more than 90% of patients surveyed indicated that IH symptoms had a moderate to high impact on their life," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. "The Vibrance-3 phase 2 study builds on encouraging data from our phase 1b, proof-of-concept study of ALKS 2680 in patients with IH, and we look forward to further characterizing its safety and efficacy profile in this patient population." Vibrance-3 is a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of ALKS 2680 in adults with IH. Participants will be randomized to receive one of three doses of ALKS 2680 (10 mg, 14 mg or 18 mg) or placebo to be taken once-daily for eight weeks. The primary endpoint will assess, by dose level, whether participants taking ALKS 2680 experience a greater decrease in sleepiness compared to participants taking placebo alone, as measured by the change in Epworth Sleepiness Scale (ESS) score. Secondary endpoints include change in Idiopathic Hypersomnia Severity Scale (IHSS) score and incidence of adverse events. The study is expected to enroll approximately 96 patients with IH across sites in the U.S., Australia and Europe. Participants who complete the study will be eligible to continue in a long-term, open-label, safety study (NCT06767683). More information can be found at (identifier: NCT06843590) and (for U.S. audiences only). Vibrance-1 and Vibrance-2, phase 2 studies evaluating the safety and efficacy of ALKS 2680 in adults with narcolepsy type 1 (NCT06358950) and narcolepsy type 2 (NCT06555783), respectively, are currently ongoing. About ALKS 2680 ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain.2 Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease.3 Once-daily oral administration of ALKS 2680 was previously evaluated in a phase 1 study in healthy volunteers and patients with NT1, NT2 and IH, and is currently being evaluated in the phase 2 Vibrance-1, Vibrance-2 and Vibrance-3 studies in patients with NT1, NT2 and IH, respectively. About Idiopathic Hypersomnia Idiopathic hypersomnia (IH) is a rare, chronic, neurological sleep disorder characterized by excessive daytime sleepiness despite normal sleep durations.4,5 Additional common symptoms can include severe sleep inertia (individuals may feel groggy or disoriented for prolonged periods after waking up), unrefreshing naps, fatigue and cognitive dysfunction.6,7 The underlying neuropathology of idiopathic hypersomnia is unknown.4 IH affects an estimated 40,000 people in America.8 About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of ALKS 2680 for the treatment of narcolepsy and idiopathic hypersomnia; and the company's expectations regarding clinical development activities for ALKS 2680. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether ALKS 2680 could be shown to be ineffective or unsafe; potential changes in the cost, scope and duration of the ALKS 2680 development program; whether preclinical and initial clinical results for ALKS 2680 will be predictive of results of future clinical studies or real-world results; whether future clinical studies or future stages of ongoing clinical studies for ALKS 2680 will be initiated or completed on time or at all; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2024 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. 1 The Illuminate Hypersomnia "Voice of the Patient" Report. Contains data from 811 survey respondents conducted in spring 2024. 2 Buysse, D. Diagnosis and assessment of sleep and circadian rhythm disorders. Journal of Psychiatric Practice. 2005; 11(2):102-115 3 Ten-Blanco M, Flores A, Cristino L, Pereda-Perez I. Targeting the orexin/hypocretin system for the treatment of neuropsychiatric and neurodegenerative diseases: From animal to clinical studies. Frontiers in Neuroendocrinology. 2023;69(101066). 4 Trotti LM, Arnulf I. Idiopathic Hypersomnia and Other Hypersomnia Syndromes. Neurotherapeutics. 2021;18(1):20-31. doi:10.1007/s13311-020-00919-1 5 American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014. 6 Trotti LM. Waking up is the hardest thing I do all day: Sleep inertia and sleep drunkenness. Sleep Med Rev 2016. 7 Vernet C, Leu-Semenescu S, Buzare MA, Arnulf I. Subjective symptoms in idiopathic hypersomnia: beyond excessive sleepiness. J Sleep Res. 2010;19:525–534 8 Acquavella et al., J Clin Sleep Med 16:1255 (2020) Alkermes Contacts: For Investors: Sandy Coombs, +1 781 609 6377 For Media: Gretchen Murphy, +1 781 609 6419 SOURCE Alkermes plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED