Alkermes plc announces intent to separate oncology business

— Alkermes focuses on profitable growth in pure-play, commercial-stage neuroscience businesses —

— Separation promises to unlock value through enhanced strategic focus, simplified capital allocation decisions, and a unique investment profile—

— The company will host a webcast today at the following locations 8 a.m. ET —

Dublin, November 2022 /PRNewswire/ — Alkermes plc (NASDAQ: ALKS) today announced that its Board of Directors (Board of Directors) has approved the exploration of the separation of its commercial-stage neuroscience business and development-stage oncology business. Together with the board of directors and outside financial and legal counsel, the company plans to explore the separation of the oncology business as a separate public company (Oncology Co.) as part of an ongoing review of strategic alternatives for the oncology business.

Alkermes sees spin-off of the oncology business into Oncology Co. Will:

• Develop clear strategic priorities for each business;
• Build independent and unique management teams with relevant therapeutic expertise based on each business’ unique strategic priorities and opportunities;
• Simplify capital allocation decisions and increase flexibility to more directly align growth and investment strategies with each business’ respective goals; and
• To enable capital markets to better assess the value, performance and potential of each business and to attract the right long-term shareholder base for each business.

“Alkermes will continue to build on our heritage of innovation and excellence in neuroscience. With strong revenue driven by the growth of our proprietary products, specialized commercial infrastructure in neuropsychiatry and addiction, and proven drug development capabilities, independent neuroscience The science business represents Alkermes CEO Richard Pops said: “With nemvaleukin now in two potential registration studies, the oncology business has a compelling stand-alone investment thesis based on the potential of this potentially first-in-class cancer treatment. Medical and economic value. We believe separating the oncology business at this time will best support and position nemvaleukin for success, create value for shareholders, and facilitate the efficient advancement of our engineered cytokine preclinical pipeline. “

Expected business profile:

Alkermes: Profitable pure-play commercial-stage neuroscience company
Alkermes will continue to focus on significant unmet needs in neuroscience and drive growth of its proprietary commercial product: LYBALVI^®Aristada^®/Aristada initial^® and VIVITROL^®The company will also focus on advancing the development of its neurological disease-focused pipeline, including ALKS 2680, an orexin 2 receptor agonist for the treatment of narcolepsy. Alkermes expects to retain manufacturing and royalty income related to its licensed products and third-party products that use the company’s licensed proprietary technology. Following the separation of the oncology business, Alkermes expects to benefit from improved profitability and continued balance sheet strength. Richard Pops will continue as CEO and Chairman of Alkermes.

Oncology Co.: Pure-Play Development-Stage Oncology Company
The Oncology business will continue to focus on the discovery and development of cancer therapeutics, including the continued development of a new investigational engineered interleukin-2 (IL-2) variant immunotherapy, nemvaleukin alfa (nemvaleukin). Nemvaleukin is currently conducting potential registry studies in two difficult-to-treat tumor types: platinum-resistant ovarian cancer and mucosal melanoma. By selectively targeting the IL-2 pathway, nemvaleukin has broad potential clinical utility across multiple tumor types and offers the potential for significant value creation as the development program progresses. Assets expected to be isolated also include a range of novel, preclinical, engineered cytokines, including tumor-targeted divisions interleukin 12 (IL-12) and interleukin 18 (IL-18).

“The potential separation of the oncology business from Alkermes’ neuroscience business will provide a platform to enhance the performance of both companies and unlock shareholder value. With the early launch of LYBALVI and the progress of the nemvaleukin development program, the value proposition for each neuroscience and oncology Part of the learning business has come into sharper focus. Going forward, the Board agrees that simplified resource and capital allocation decisions, tailored operating structures and unique leadership teams will best meet the unique needs of each business, and each Each has a clearly defined strategic focus,” said Nancy WiesenskyLead Independent Director of the Alkermes Board of Directors.

Process and Strategy Principles
In 2020, the Board, working closely with management and external financial and legal counsel, began evaluating a broad range of potential strategic options for the company’s non-core assets, including evaluating strategic partnerships and other opportunities in the oncology business. With nemvaleukin’s entry into potential registrational studies and recent developments in the healthcare industry, the board and leadership believe it is in the best interests of patients, shareholders and other key stakeholders to separate the oncology business at this time.

financial impact
In preparation for a possible separation, Alkermes will continue to carefully manage the cost structure of each business. The company expects to incur transaction and separation charges as part of the process of separating and transitioning the two businesses. Alkermes expects to provide more financial details at a later date.

transition and timing
More details on the spin-off, including the name of the proposed Oncology company, its executive management team and board of directors, and financial details of the two proposed companies, will be provided at a later date. The separation, if completed, is expected to be completed in the second half of 2023. Alkermes expects Oncology Co. to be located in the company’s existing Waltham, Massachusetts campus.facilities and research and manufacturing operations in Wilmington, Ohio and Athlone, Ireland Will stay at Alkermes.

The separation of the two businesses will be subject to customary closing conditions and final approval by Alkermes’ Board of Directors. There is no guarantee of the final timing or structure of the expected separation, or that the separation will eventually occur.

Morgan Stanley and Bank of America Securities acted as Alkermes, Goodwin Procter LLP and Arthur Cox act as its legal advisor.

About Alkermes plc
Alkermes plc is a fully integrated global biopharmaceutical company developing innovative medicines in neuroscience and oncology. The company has a proprietary commercial portfolio focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, as well as a pipeline of product candidates in development for neurological diseases and cancer. Alkermes is headquartered in Dublin, Ireland, with an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit the Alkermes website at www.alkermes.com.

Note Regarding Forward-Looking Statements
Certain statements 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 regarding the company’s exploration of the separation of its neuroscience and oncology businesses , including the expected timing, structure, benefits and costs of a potential separation; the company’s expectations regarding its business profile, future financial and operating results, business plans or prospects for both businesses (if separated), including its assumptions about growth and profitability, its Commitments and plans to drive shareholder value, and the business’ ability to execute on their respective strategic priorities and advance their growth plans; and the potential therapeutic and commercial value of the company’s products. The company cautions that forward-looking statements are inherently uncertain. Forward-looking statements are neither commitments 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 as a result of various risks and uncertainties.These risks and uncertainties include: the company may not ultimately separate the oncology business in 2023 or at all; unexpected developments, costs or difficulties that could delay or otherwise negatively impact the potential separation; disruption; the company may not be able to make timely or cost-effective changes necessary to operate its neuroscience and oncology businesses independently; potential departures or announcements may adversely affect the company’s ability to attract or retain key personnel; corporate governance its cost structure efforts may not produce the expected results; the company may not achieve long-term profitability or profitability goals in a timely manner or at all; the impact of the ongoing COVID-19 pandemic on the company’s business, results of operations or financial condition, including healthcare systems and effects on patients and healthcare providers’ access to products marketed by the Company; adverse outcomes of arbitration or litigation, including so-called “Section IV” litigation and other patent litigation, or relating to Company products or products using Company proprietary technology other disputes, including arbitration proceedings with Janssen; clinical development activities may not be completed on time or at all; the results of company development activities may not be positive, or the ultimate outcome of such activities, the results of future development activities or the real-world results; the U.S. Food and Drug Administration (FDA) may disagree with the company’s regulatory approval strategy or components of the company’s marketing application; the FDA or regulatory agencies outside the United States may make adverse decisions about the company’s products; the company and its licensees may not continue to successfully commercialize its products; payment rates or compensation for the company’s products may decrease, or the company’s financial obligations to government payers may increase; the company’s products may prove difficult to manufacture, The exclusive rights of third parties are excluded from commercialization, or there are unintended side effects, adverse reactions, or misuse events; and the risks and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31st March 2021 and the company’s subsequent filings with the U.S. Securities and Exchange Commission (SEC), including the company’s quarterly report on Form 10-Q for the quarter ended September 30 March 2022, available on the SEC’s website at www.sec.gov. Existing and potential 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 duty to update or revise any forward-looking statements contained in this press release.

VIVITROL^® is a registered trademark of Alkermes, Inc.and Aristada^®Aristada^® and LYBALVI^® is a registered trademark of Alkermes Pharma Ireland Limited and is used by Alkermes, Inc. Under license.

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