Alkermes : JPM slides 1 10 22 10am.pdf

Alkermes: Advancing Key Business Priorities in 2022

Richard Pops

Chief Executive Officer

40th Annual J.P. Morgan Healthcare Conference

January 2022

© 2022 Alkermes. All rights reserved.

Forward-Looking Statements

Certain statements set forth in this presentation 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 with respect to its current and future financial and operating performance, business plans or prospects, including expected commercial growth drivers and development opportunities, and execution against 2022 financial expectations and long-term profitability goals; the potential therapeutic and commercial value of the company's marketed products and development candidates, including nemvaleukin alfa ("nemvaleukin")

as a cancer immunotherapy when used as monotherapy or in combination and whether delivered intravenously or subcutaneously, and its potential utility across a range of tumor types, dosing options and potential combinations with other targeted therapies; expectations regarding patent life for nemvaleukin; expectations regarding the effectiveness and potential of the company's research and development ("R&D") objective, approach and capabilities, including its molecule design and engineering capabilities; timelines, plans and expectations for development activities relating to the company's development candidates, including (i) for nemvaleukin, planned and ongoing clinical studies in the ARTISTRY development program, including plans to evaluate potential dosing flexibility, and plans to pursue strategic collaborations, (ii) for ALKS 1140, plans to advance the phase 1 program, (iii) for ALKS 2680, plans to complete IND-enabling activities and prepare for initiation of a first-in-human study, and (iv) for the engineered cytokine program, plans to advance the IL-12 and IL-18 preclinical programs to key decision points; and expectations concerning commercial activities relating to the company's products, including plans for the ongoing commercial launch of LYBALVI® and the company's ability to leverage its existing commercial infrastructure. The company cautions that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks, assumptions and uncertainties. These risks, assumptions and uncertainties include, among others: whether LYBALVI will be commercialized successfully; the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition; the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation or 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 real-world results, and preliminary data from ongoing studies may not be predictive of future or final data from such studies, results of future studies or real-world results; the U.S. Food and Drug Administration ("FDA") or other regulatory authorities may not agree with the company's regulatory approval strategies or components of the company's marketing applications, including clinical trial designs, conduct and methodologies, manufacturing processes and facilities, or the adequacy of the data or other information included in the company's regulatory submissions to support their requirements for approval, and may make adverse decisions regarding the company's products; the company and its licensees may not be able to successfully commercialize their products or support growth of revenue 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 governmental 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, assumptions and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2020 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 and on the company's website at www.alkermes.com in the "Investors-SEC filings" section. 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 presentation.

Note Regarding Trademarks: The company and its affiliates are the owners of various U.S. federal trademark registrations (®) and other trademarks (TM), including ARISTADA®, ARISTADA INITIO®, VIVITROL®, and LYBALVI®. VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. Any other trademarks referred to in this presentation are the property of their respective owners. Appearances of such other trademarks herein should not be construed as any indicator that their respective owners will not assert their rights thereto.

2	© 2022 Alkermes. All rights reserved.

Three Strategic Priorities Grounded in Strong Culture of Responsibility

Commercial		Development Pipeline		Profitability
Grow commercial		Advance pipeline of		Drive long-term
portfolio of		neuroscience and		profitability
proprietary products		oncology candidates

Patient-focused ethos and strong commitment to corporate responsibility and governance

3	© 2022 Alkermes. All rights reserved.

2021 Key Achievements Advanced Core Business Objectives

Commercial Execution		Development Pipeline		Profitability
• LYBALVI®: Approved and commercially	• Initiated nemvaleukin alfa studies in mucosal		• Focused on disciplined capital allocation and
launched	melanoma and platinum-resistant ovarian		optimized cost structure
• ARISTADA®: Drove TRx growth that	cancer to support potential registration		• Restructured commercial organization to
outpaced the aLAI market	• Initiated ALKS 1140 phase 1 FIH study		support launch of LYBALVI
• VIVITROL®: Advanced alcohol dependence	• Nominated ALKS 2680 and commenced
strategy to drive next phase of growth	IND-enabling activities

Patient-focused ethos and strong commitment to corporate responsibility and governance

• Supported research, education and patient advocacy programs to benefit	•	Continued Board of Directors refreshment efforts
	people affected by serious mental illness, addiction or cancer		•	Appointed two new independent Directors
•	Introduced new Diversity, Inclusion and Belonging employee resource groups		•	Announced retirement of two longer-serving Directors
•	Continued commitment to sustainability	•	Initiated declassification of Board of Directors

4	© 2022 Alkermes. All rights reserved.

Diversified Biopharmaceutical Company With Proven Drug Development and Commercialization Capabilities

Significant, diverse revenues with new growth opportunities

Licensed to and

commercialized by Biogen

(royalty & manufacturing revenue)

		Oncology			Neuroscience
Pipeline of novel	Nemvaleukin	•	Phase 2/3		ALKS 1140	•	Phase 1
development
Alfa	•	Advanced solid tumors			•	Neurodegenerative and
candidates designed						neurologic disorders
to target significant
IL-12	•	Discovery		ALKS 2680	•	Preclinical
unmet needs
		•	Advanced solid tumors			•	Narcolepsy

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