Alkermes plc Announces Intent to Separate Oncology Business

— Alkermes to Concentrate on Worthwhile Progress of Pure-Play, Industrial-Stage Neuroscience Enterprise —

— Separation Anticipated to Unlock Worth By means of Sharpened Strategic Focus, Simplified Capital Allocation Resolution-Making, and Distinct Funding Profiles —

— Firm to Host Webcast At the moment at 8 a.m. ET —

DUBLIN, Nov. 2, 2022 /PRNewswire/ –Alkermes plc (Nasdaq: ALKS) in the present day introduced approval by its Board of Administrators (the Board) to discover separating its commercial-stage neuroscience enterprise and development-stage oncology enterprise. The corporate, along with the Board and exterior monetary and authorized advisors, plans to discover a separation of the oncology enterprise into an impartial, publicly-traded firm (Oncology Co.) as a part of an ongoing assessment of strategic alternate options for the oncology enterprise.

Alkermes believes separation of the oncology enterprise into Oncology Co. would:

• Drive a pointy strategic focus for every enterprise;
• Set up separate and distinct administration groups with related therapeutic experience based mostly on every enterprise’ distinctive strategic priorities and alternatives;
• Simplify capital allocation decision-making and improve flexibility to pursue development and funding methods extra immediately aligned with every enterprise’ respective targets; and
• Allow the capital markets to higher assess every enterprise’ worth, efficiency and potential, and appeal to a long-term shareholder base suited to every enterprise.

“Alkermes will proceed to construct on our heritage of innovation and excellence in neuroscience. With a powerful topline pushed by the expansion of our proprietary merchandise, a specialised business infrastructure in neuropsychiatry and dependancy, and confirmed drug growth capabilities, the standalone neuroscience enterprise represents a compelling alternative to seize working leverage, drive development and profitability, and advance new potential medicines for neurological problems,” mentioned Richard Pops, Chief Government Officer of Alkermes. “With nemvaleukin now in two potential registrational research, the oncology enterprise has a compelling standalone funding thesis anchored by the potential medical and financial worth of this potential first-in-class most cancers remedy. We imagine separating the oncology enterprise presently will finest help and place nemvaleukin for fulfillment, create worth for shareholders, and allow environment friendly development of our preclinical pipeline of engineered cytokines.”

Anticipated Enterprise Profiles:

Alkermes: Worthwhile, Pure-Play Industrial-Stage Neuroscience Firm
Alkermes will retain its concentrate on important unmet wants inside neuroscience and on driving development of its proprietary business merchandise: LYBALVI^®, ARISTADA^®/ARISTADA INITIO^® and VIVITROL^®. The corporate can even concentrate on advancing the event of pipeline packages targeted on neurological problems, together with ALKS 2680, an orexin 2 receptor agonist for the therapy of narcolepsy. Alkermes expects to retain manufacturing and royalty revenues associated to its licensed merchandise and third-party merchandise utilizing the corporate’s proprietary applied sciences underneath license. Alkermes would anticipate to learn from enhanced profitability and continued stability sheet energy following a separation of the oncology enterprise. Richard Pops will proceed as Chief Government Officer and Chairman of Alkermes.

Oncology Co.: Pure-Play Growth-Stage Oncology Firm
The oncology enterprise would proceed to concentrate on the invention and growth of most cancers therapies, together with the continued growth of nemvaleukin alfa (nemvaleukin), a novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy. Nemvaleukin is at the moment in potential registration enabling research in two difficult-to-treat tumor varieties: platinum-resistant ovarian most cancers and mucosal melanoma. By selectively focusing on the IL-2 pathway, nemvaleukin has broad potential medical utility in a wide range of tumor varieties and provides the potential for important worth creation as the event program advances. The property topic to a separation are additionally anticipated to incorporate a portfolio of novel, preclinical, engineered cytokines, together with tumor-targeted cut up interleukin-12 (IL-12) and interleukin-18 (IL-18).

“The potential separation of the oncology enterprise from Alkermes’ neuroscience enterprise would supply a platform to boost the efficiency of each companies and unlock shareholder worth. With the early traction of the LYBALVI launch and progress within the nemvaleukin growth program, the worth propositions for every of the neuroscience and oncology companies have come extra clearly into focus. As we glance forward, the Board unanimously agrees that the distinctive wants of every enterprise could be finest served by simplified useful resource and capital allocation resolution making, tailor-made working constructions, and distinct management groups, every with a clearly outlined strategic focus,” mentioned Nancy Wysenski, Lead Unbiased Director of Alkermes’ Board.

Course of & Strategic Rationale
In 2020, the Board, working intently with administration and exterior monetary and authorized advisors, commenced an analysis of a broad vary of potential strategic choices for the corporate’s non-core property, together with an analysis of strategic partnerships and different alternatives for its oncology enterprise. With the development of nemvaleukin into potential registration enabling research and up to date developments within the healthcare business typically, the Board and management imagine that separating the oncology enterprise presently is in the very best pursuits of sufferers, shareholders and different key stakeholders.

Monetary Implications
In preparation for a possible separation, Alkermes will proceed to rigorously handle the associated fee construction of every enterprise. The corporate would anticipate to incur transactional and separation bills as a part of a course of to separate and transition the 2 companies. Alkermes expects to supply further monetary particulars at a later date.

Transition and Timing
Extra particulars concerning a separation, together with the identify of the contemplated Oncology Co., its govt administration workforce and its board of administrators, in addition to monetary particulars for the 2 contemplated corporations, could be supplied at a later date. The separation, if consummated, is anticipated to be accomplished within the second half of 2023. Alkermes anticipates Oncology Co. could be positioned inside the firm’s current Waltham, Mass. campus. The amenities and analysis and manufacturing operations in Wilmington, Ohio and Athlone, Eire will stay with Alkermes.

Separation of the 2 companies could be topic to customary closing circumstances and ultimate approval by Alkermes’ Board of Administrators. There might be no assurance concerning the final word timing or construction of a contemplated separation or that the separation will in the end happen.

Morgan Stanley and BofA Securities are serving as monetary advisers to Alkermes, and Goodwin Procter LLP and Arthur Cox are serving as its authorized counsel.

About Alkermes plc
Alkermes plc is a fully-integrated, world biopharmaceutical firm growing progressive medicines within the fields of neuroscience and oncology. The corporate has a portfolio of proprietary business merchandise targeted on alcohol dependence, opioid dependence, schizophrenia and bipolar I dysfunction, and a pipeline of product candidates in growth for neurological problems and most cancers. Headquartered in Dublin, Eire, Alkermes has a analysis and growth heart in Waltham, Massachusetts; a analysis and manufacturing facility in Athlone, Eire; and a producing facility in Wilmington, Ohio. For extra data, please go to Alkermes’ web site at www.alkermes.com.

Notice Relating to Ahead-Trying Statements
Sure statements set forth on this press launch represent “forward-looking statements” inside the which means of the Non-public Securities Litigation Reform Act of 1995, as amended, together with, however not restricted to, statements regarding: the corporate’s intent to discover separating its neuroscience and oncology companies, together with the anticipated timing, construction, advantages and prices of a possible separation; the corporate’s expectations in regards to the enterprise profiles and future monetary and working efficiency, enterprise plans or prospects of the 2 companies if separated, together with its assumptions concerning development and profitability, its dedication and plans to drive shareholder worth, and the power of the companies to execute on their respective strategic priorities and advance their growth packages; and the potential therapeutic and business worth of the corporate’s merchandise. The corporate cautions that forward-looking statements are inherently unsure. The forward-looking statements are neither guarantees nor ensures and they’re essentially topic to a excessive diploma of uncertainty and threat. Precise efficiency and outcomes might differ materially from these expressed or implied within the forward-looking statements resulting from numerous dangers and uncertainties. These dangers and uncertainties embody, amongst others: the corporate might not in the end separate the oncology enterprise throughout 2023 or in any respect; unanticipated developments, prices or difficulties which will delay or in any other case negatively have an effect on a possible separation; disruption to the corporate’s operations ensuing from a possible separation; the corporate could also be unable to make, on a well timed or cost-effective foundation, the adjustments essential to individually function its neuroscience and oncology companies; a possible separation or announcement thereof might adversely impression the corporate’s capability to draw or retain key personnel; the corporate’s efforts to handle its price construction might not yield the supposed outcomes; the corporate might not be capable of obtain long-term profitability or its profitability targets in a well timed method or in any respect; the impacts of the continued COVID-19 pandemic on the corporate’s enterprise, outcomes of operations or monetary situation, together with impacts on healthcare techniques and on affected person and healthcare supplier entry to the corporate’s marketed merchandise; the unfavorable consequence of arbitration or litigation, together with so-called “Paragraph IV” litigation and different patent litigation, or different disputes associated to the corporate’s merchandise or merchandise utilizing the corporate’s proprietary applied sciences, together with the arbitration proceedings with Janssen; medical growth actions might not be accomplished on time or in any respect; the outcomes of the corporate’s growth actions might not be optimistic, or predictive of ultimate outcomes from such actions, outcomes of future growth actions or real-world outcomes; the U.S. Meals and Drug Administration (FDA) might not agree with the corporate’s regulatory approval methods or parts of the corporate’s advertising functions; the FDA or regulatory authorities exterior the U.S. might make hostile choices concerning the corporate’s merchandise; the corporate and its licensees might not be capable of proceed to efficiently commercialize their merchandise; there could also be a discount in cost charge or reimbursement for the corporate’s merchandise or a rise within the firm’s monetary obligations to authorities payers; the corporate’s merchandise might show tough to fabricate, be precluded from commercialization by the proprietary rights of third events, or have unintended unwanted side effects, hostile reactions or incidents of misuse; and people dangers and uncertainties described underneath the heading “Danger Elements” within the firm’s Annual Report on Kind 10-Okay for the yr ended Dec. 31, 2021 and in subsequent filings made by the corporate with the U.S. Securities and Alternate Fee (SEC), together with the corporate’s Quarterly Report on Kind 10-Q for the quarter ended Sept. 30, 2022, which can be found on the SEC’s web site at www.sec.gov. Present and potential buyers are cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date hereof. Besides as required by legislation, the corporate disclaims any intention or accountability for updating or revising any forward-looking statements contained on this press launch.

VIVITROL^® is a registered trademark of Alkermes, Inc. and ARISTADA^®, ARISTADA INITIO^® and LYBALVI^® are registered emblems of Alkermes Pharma Eire Restricted, utilized by Alkermes, Inc. underneath license.

SOURCE Alkermes plc