Samidorphan/olanzapine

— Total Revenues of $1.66 Billion in 2023; Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year — — GAAP Net Income of $356 Million and Diluted GAAP Earnings per Share of $2.10 for 2023 — — Company Expects to Generate 30% EBITDA Margin in 2024 — DUBLIN, Feb. 15, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter and year ended Dec. 31, 2023 and provided financial expectations for 2024. "We entered 2024 as a pure-play neuroscience company and are well positioned to deliver on our strategic priorities to drive growth of our proprietary commercial products, advance the clinical development of ALKS 2680 for the treatment of narcolepsy, and generate significant cash flow," said Richard Pops, Chief Executive Officer of Alkermes. "Our financial expectations for 2024 reflect our sharpened strategic focus and our work to position the business for sustained profitability and growth. As we look ahead, 2024 will be an important year as we focus on maintaining strong momentum in the launch of LYBALVI® and advancing and expanding our development pipeline. We look forward to sharing our progress." Key Financial Highlights Please refer to Note 2 below for details related to certain tax provisions recorded during the quarter ended Dec. 31, 2023 which impacted GAAP Net Income and Non-GAAP Net Income during the quarter. Revenue Highlights LYBALVI - Revenues for the fourth quarter and year ended Dec. 31, 2023 were $56.2 million and $191.9 million, respectively. - Fourth quarter revenues and total prescriptions grew 61% and 65%, respectively, compared to the fourth quarter of 2022. ARISTADAi - Revenues for the fourth quarter and year ended Dec. 31, 2023 were $83.4 million and $327.7 million, respectively. - Fourth quarter revenues and total prescriptions (on a months of therapy basis) grew 5% and 4%, respectively, compared to the fourth quarter of 2022. VIVITROL - Revenues for the fourth quarter and year ended Dec. 31, 2023 were $102.4 million and $400.4 million, respectively. Manufacturing & Royalties - Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the fourth quarter and year ended Dec. 31, 2023 were $75.2 million and $486.1 million, respectively. 2023 royalty revenues included $195.4 million of back royalties and associated interest related to U.S. net sales of these products in 2022, following favorable resolution of the arbitration proceedings related to these products in the second quarter of 2023. - VUMERITY® revenues for the fourth quarter and year ended Dec. 31, 2023 were $33.6 million and $129.3 million, respectively. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. 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 certain one-time expenses related to the successful resolution of legal proceedings including the Janssen arbitration and VIVITROL patent litigation. Balance Sheet At Dec. 31, 2023, the company recorded cash, cash equivalents and total investments of $813.4 million, compared to $740.1 million at Dec. 31, 2022. The company's total debt outstanding as of Dec. 31, 2023 was $290.7 million. Share Repurchase Program On Feb. 15, 2024, the company's board of directors approved a new share repurchase program, authorizing the company to repurchase up to $400 million of the company's ordinary shares (exclusive of any fees, commissions or other expenses related to such repurchases). The program does not have an expiration date and can be discontinued at any time. Please refer to Note 3 below for further details. Financial Expectations for 2024 All line items are according to GAAP, except as otherwise noted. Recent Events - In November 2023, the company completed the separation of its oncology business into Mural Oncology plc, a new, independent, publicly-traded company. - In December 2023, the company announced that it had entered into a definitive agreement to sell its development and manufacturing facility in Athlone, Ireland to Novo Nordisk. Under the terms of the agreement, upon closing of the transaction, Alkermes will be entitled to a one-time cash payment of $92.5 million for the facility and related assets, subject to customary adjustments in accordance with the agreement. The transaction is expected to close in mid-2024, subject to certain closing conditions. - In January 2024, the company announced topline results from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI in patients with schizophrenia, schizophreniform disorder or bipolar I disorder for up to four years of treatment, following treatment received in prior LYBALVI studies. - In January 2024, the company announced that it had completed the narcolepsy type 1 cohort in its phase 1b study of ALKS 2680, the company's novel, investigational orexin 2 receptor agonist in development for the treatment of narcolepsy. The data supported dose selection of 4 mg, 6 mg, and 8 mg once daily for the planned phase 2 study in narcolepsy type 1, which the company plans to initiate in the first half of 2024. 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 (FASB) Accounting Standards Codification (ASC) 205, Discontinued Operations. Accordingly, the accompanying consolidated financial statements for all periods presented have been updated to present the assets and liabilities associated with the oncology business as discontinued operations on the consolidated balance sheets, and the results of all discontinued operations reported as a separate component of loss in the consolidated statements of operations and comprehensive income (loss). 2. During the quarter ended Dec. 31, 2023, the company recorded a $102.2 million net tax benefit from continuing operations and an income tax provision of $6.9 million from discontinued operations driven by a $161.0 million tax benefit related to the partial release of a valuation allowance against certain Irish deferred tax assets, partially offset by (i) an income tax expense related to a reduced foreign derived intangible income deduction following the publication of new guidance on the application of Section 174 of the U.S. Internal Revenue Code of 1986, as amended, and (ii) a one-time charge related to the transfer of certain intellectual property in connection with the separation of the company's oncology business. The tax benefit related to the release of the valuation allowance was excluded from non-GAAP net income due to the one-time nature of the benefit. 3. Under the share repurchase program, the company may repurchase ordinary shares of the company from time to time in an aggregate amount of up to $400 million (exclusive of any fees, commissions or other expenses related to such repurchases), subject to general business and market conditions and other investment opportunities, through open market purchases, conducted through Rule 10b5-1 plans or 10b-18 plans pursuant to the Securities Exchange Act of 1934, as amended, or through other mechanisms permitted by the company's constitution. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Thursday, Feb. 15, 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 . 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. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This 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. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. 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 company's expectations concerning its future financial and operating performance, business plans or prospects, including its ability to grow its proprietary commercial products, generate cash and sustain profitability; the company's expectations regarding advancement of its development pipeline, including plans and expected timelines for the ALKS 2680 clinical development program, including initiation of the phase 2 study; the company's expectations regarding its share repurchase program; and the company's expectations regarding the sale of its development and manufacturing facility in Athlone, Ireland. 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 sustain profitability; the unfavorable outcome of arbitration or litigation, including so-called "Paragraph IV" litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company's products or products using the company's proprietary technologies; 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; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; 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 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. 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®, INVEGA HAFYERA®, INVEGA SUSTENNA®, 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. (tables follow) Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 SOURCE Alkermes plc

AbbVie, Amarin and many other companies presented at the J.P. Morgan Healthcare Conference on Wednesday. As the J.P. Morgan Healthcare Conference moves into its third day, we're covering the latest developments here.  Be sure to check back throughout today, with updates from AbbVie, Amarin, WuXi AppTec and more still to come. UPDATED: Wednesday, Jan. 10 at 7:00 p.m. ET Vertex has signed a reimbursement pact with a Blue Shield Blue Cross contracting organization for CRISPR Therapeutics-partnered gene-editing therapy Casgevy covering 100 million people, Vertex CEO Reshma Kewalramani, M.D., said during a presentation earlier this week. But before official reimbursement policies cover a broad population, Kewalramani stressed that some patients may get Casgevy through single agreements. So far, bluebird bio's rival gene replacement therapy Lyfgenia has secured more coverage than Casgevy. But Vertex learned from its market research that physicians prefer gene-editing therapy technology over gene replacement therapy, Kewalramani said.  "We have not specifically questioned on why, but as we look qualitatively at the data, there is awareness of the difference between gene editing and gene therapy," Kewalramani said. "There is awareness that by mechanism of action, there is the possibility for random insertional mutagenesis with a gene therapy approach that uses a viral delivery mechanism. And there is awareness of the safety and efficacy data [...] for what the benefit-risk and the efficacy is. And I expect that that is the reason there is this preference for gene editing." In terms of treatment centers, bluebird is ahead with 35 activated sites, whereas Vertex has nine. Bluebird plans to expand to 48 sites that currently also offer its beta thalessemia product Zynteglo soon, while Vertex also targets nearly 50 sites this year. UPDATED: Wednesday, Jan. 10 at 2:10 p.m. ET Despite the much-anticipated entrance of a longer-acting product to compete with AbbVie’s Botox in the cosmetic market, the Illinois-based drugmaker is not seeing any evidence of sales erosion, AbbVie said Wednesday. The pharma giant also addressed its recent acquisitions of antibody-drug conjugate biotech ImmunoGen and neuroscience specialist Cerevel. With both deals, AbbVie is targeting “long-term growth,” chief operating officer Rob Michael said during the event. “Even though these two deals will add some level of revenue this decade, it wasn’t really about that. It was more about the next decade,” Michael said. “We have clear line of sight for this decade with our current portfolio. We didn’t need to go outside to supplement that.” Going forward, the company will target “early-stage opportunities that will be smaller in size," Michael added. UPDATED: Wednesday, Jan. 10 at 12:10 p.m. ET Emboldened by the recent approval of Vertex-partnered gene therapy Casgevy, CRISPR Therapeutics CEO Samarth Kulkarni opined over humanity’s ability to edit its own genome and fix its own diseases as “another form of singularity” at this year’s J.P. Morgan Healthcare Conference. Late last year, Vertex and CRISPR’s medicine racked up approvals in sickle cell disease (SCD) in Europe, the United Kingdom and the U.S. And while there’s already a “robust support system” for Casgevy in the States, the advanced therapeutic has significant potential abroad as well, Kulkarni explained. “There are a tremendous number of patients that suffer from both severe sickle cell disease and thalassemia in the Middle East, in parts of Europe and in Asia,” he said. Meanwhile, more approvals are already coming in in places like Saudi Arabia and Bahrain, where the “unmet need is very high.” UPDATED: Wednesday, Jan. 10 at 11:40 a.m. ET Alexander Hardy, formerly the CEO at Genentech, is five weeks into his new job as CEO at BioMarin and made his priorities clear Tuesday at the J.P. Morgan Healthcare Conference. Hardy’s primary mission will be to maximize the commercial potential of dwarfism drug Voxzogo, which has the potential to increase its patient pool from 21,000 to 600,000. Secondly, Hardy is focused on the launch of newly approved hemophilia A gene therapy Roctavian. Thirdly, Hardy will have to make tough decisions as the company looks to cut its R&D spend. Story UPDATED: Wednesday, Jan. 10 at 9:40 a.m. ET After the most transformational year Alkermes' history, the company is stripped down and anxious to carry on in its new role as a pure-play neuroscience specialist. In an interview with Fierce Pharma, chief operating officer Blair Jackson described last year as "a year of resetting and clearing the decks and simplifying the story." Specifically, the company spun off its oncology division and sold a plant in Ireland, among other developments. Now, the company is focused on the launch of Lybalvi and a mid-stage pipeline candidate. Story