—    First Quarter Revenues of $350.4 Million — —    GAAP Net Income from Continuing Operations of $38.9 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.23 — —    Company Reiterates 2024 Financial Expectations — DUBLIN, May 1, 2024 /PRNewswire/ --  Alkermes plc (NASDAQ:ALKS) today reported financial results for the first quarter of 2024. "The first quarter of 2024 marks our first full quarter as a profitable, pure-play neuroscience company. During the quarter, we continued to advance our strategic priorities across the business, highlighted by solid underlying prescription growth for LYBALVI® and advancement of ALKS 2680, our novel, investigational, oral orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy," said Richard Pops, Chief Executive Officer of Alkermes. "For ALKS 2680, we recently initiated our Vibrance-1 phase 2 study in narcolepsy type 1 and announced positive topline phase 1b results in narcolepsy type 2. With these new data now in hand, we plan to initiate a phase 2 study in narcolepsy type 2 in the second half of 2024. In an area where there remains significant unmet patient need, orexin 2 biology represents an important new potential approach to treating disorders characterized by excessive daytime sleepiness. ALKS 2680 is the first candidate from our orexin portfolio to advance in the clinic and we plan to share details regarding our other orexin development programs later this year." Key Financial Highlights Revenues (In millions) Three Months Ended March 31, 2024 2023 Total Revenues $ 350.4 $ 287.6 Total Proprietary Net Sales $ 233.5 $ 214.7      VIVITROL® $ 97.7 $ 96.7      ARISTADA®i $ 78.9 $ 80.1      LYBALVI® $ 57.0 $ 38.0   Profitability (In millions) Three Months Ended March 31, 2024 2023 GAAP Net Income (Loss) From Continuing Operations $ 38.9 $ (12.1) GAAP Net Loss From Discontinued Operations $ (2.1) $ (29.8) GAAP Net Income (Loss) $ 36.8 $ (41.8) Non-GAAP Net Income From Continuing Operations $ 76.2 $ 30.1 Non-GAAP Net Loss From Discontinued Operations $ (2.1) $ (27.6) Non-GAAP Net Income $ 74.1 $ 2.4 EBITDA From Continuing Operations $ 51.5 $ 7.2 EBITDA From Discontinued Operations $ (2.5) $ (36.0) EBITDA $ 49.0 $ (28.8)   Revenue Highlights LYBALVI Revenues for the quarter were $57.0 million. Revenues and total prescriptions for the quarter grew 50% and 56%, respectively, compared to the first quarter of 2023. Inventory in the channel decreased by approximately $2.3 million during the quarter. ARISTADAi Revenues for the quarter were $78.9 million. Inventory in the channel decreased by approximately $3.6 million during the quarter. VIVITROL Revenues for the quarter were $97.7 million. Inventory in the channel decreased by approximately $4.3 million during the quarter. Manufacturing & Royalty Revenues Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $62.7 million. VUMERITY® manufacturing and royalty revenues for the quarter were $31.3 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. (In millions) Three Months Ended March 31, 2024 2023 R&D Expense – Continuing Operations $ 67.6 $ 63.8 R&D Expense – Discontinued Operations $ 2.5 $ 29.9 SG&A Expense – Continuing Operations $ 179.7 $ 167.8 SG&A Expense – Discontinued Operations $ - $ 6.6   Year-over-year increase in R&D expense related to continuing operations was driven primarily by investment in the ALKS 2680 development program and approximately $3.2 million of non-recurring share-based compensation expenses. Year-over-year increase in SG&A expense related to continuing operations was driven primarily by investment in the LYBALVI direct-to-consumer advertising campaign and approximately $6.2 million of non-recurring share-based compensation expenses. Balance Sheet At March 31, 2024, the company recorded cash, cash equivalents and total investments of $807.8 million, compared to $813.4 million at Dec. 31, 2023. The company's total debt outstanding as of March 31, 2024 was $290.1 million. Financial Expectations for 2024 Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024. Recent Events In March 2024, the company announced the appointment of new independent director Nancy S. Lurker to the company's board of directors. In April 2024, the company presented data from its long-term safety study of LYBALVI (olanzapine and samidorphan) at the 2024 Congress of the Schizophrenia International Research Society (SIRS). In April 2024, the company announced positive topline results from the narcolepsy type 2 and idiopathic hypersomnia cohorts in its phase 1b study of ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy. In April 2024, the company announced initiation of the Vibrance-1 phase 2 study of ALKS 2680 in patients with narcolepsy type 1. Notes and Explanations 1. The company determined that upon the separation of its 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, 2023. 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 Wednesday, May 1, 2024, 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 plcAlkermes 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. 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 non-GAAP net income and 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. Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense. 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, non-GAAP net income and 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, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity.