false Alkermes plc. 0001520262 0001520262 2021-02-11 2021-02-11

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): February 11, 2021

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

 

Ireland		001-35299				98-1007018
(State or other jurisdiction		(Commission				(IRS Employer
of incorporation)		File Number)				Identification No.)
Connaught House, 1 Burlington Road
Dublin 4, Ireland D04 C5Y6
(Address of principal executive offices)

 

Registrant's telephone number, including area code: + 353-1-772-8000

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐		Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐		Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐		Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐		Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Ordinary shares, $0.01 par value		ALKS		Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

		Emerging growth company  ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

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Item 2.02 Results of Operations and Financial Condition.

On February 11, 2021, Alkermes plc (the “Company”) announced financial results for the three months and year ended December 31, 2020 and financial expectations for the year ending December 31, 2021. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on February 11, 2021 discussing such financial results and expectations are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively. This information, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press release issued by Alkermes plc dated February 11, 2021 announcing financial results for the three months and year ended December 31, 2020 and financial expectations for the year ending December 31, 2021.
99.2		Investor presentation to be displayed by Alkermes plc on February 11, 2021.
104		Cover page interactive data file (embedded within the Inline XBRL document).

 

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	ALKERMES PLC
Date: February 11, 2021	By:		/s/ Iain M. Brown
			Iain M. Brown
			Senior Vice President, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

 

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Exhibit 99.1

 

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2020 and Provides Financial Expectations for 2021

—Revenues of $1.04 Billion in 2020, GAAP Loss per Share of $0.70 and Basic and Diluted Non-GAAP Earnings per Share of $0.43—

—Financial Expectations for 2021 Reflect Anticipated Growth of Proprietary Products and Investment in Strategic Priorities for Long-Term Value Creation—

 

DUBLIN, Feb. 11, 2021 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter and year ended Dec. 31, 2020 and provided financial expectations for 2021.

 

“2020 was a demonstration of the resiliency of our organization, as we adapted our business to endure a pandemic that has proved to be one of the most disruptive events in our recent history. Despite the challenges posed by COVID-19, we achieved significant growth of net sales from our portfolio of proprietary commercial products, advanced our pipeline of neuroscience and oncology candidates, and announced a Value Enhancement Plan designed to drive growth and improve operational and financial performance,” said Richard Pops, Chief Executive Officer of Alkermes. “We are focused on value creation in 2021 as we seek to grow and diversify our commercial portfolio, demonstrate the value of our R&D investments, and manage the company for growth and long-term profitability, all while striving to make a meaningful difference in the lives of people living with serious mental illness, addiction and cancer.”

 

Quarter Ended Dec. 31, 2020 Financial Highlights

 

Year Ended Dec. 31, 2020 Financial Results

Revenues

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Costs and Expenses

 

Net Loss/Net Income

 

Balance Sheet

 

“Our solid 2020 financial results demonstrate efficient management of our business from a financial and operational perspective in response to the significant disruptions caused by the pandemic. These efforts underscore our focus on execution and reflect our commitment to driving bottom line growth,” commented Iain Brown, Chief Financial Officer of Alkermes. “We enter 2021 well positioned to execute on our strategic priorities and work toward the long-term profitability margin targets set forth in our Value Enhancement Plan. We plan to achieve these targets through commercial execution, focused investment in the company’s future growth drivers and continued efforts to optimize our infrastructure and operating model. Our financial expectations for 2021 reflect anticipated growth of our commercial portfolio and focused investments to support the anticipated launch of LYBALVI™ and advance the clinical development program for nemvaleukin, as we position these programs to drive future value creation.”

 

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Financial Expectations for 2021

The following financial expectations for 2021 are based on recent trends and assume continuation of such trends into the first half of the year, and an anticipated improvement in patient access to treatment providers and to the company’s commercial products in the second half of the year. If patient access does not improve as anticipated, or if new COVID-19-related disruptions emerge, the company’s ability to meet these expectations could be negatively impacted. All line items are according to GAAP, except as otherwise noted.

 

 

*R&D expense expectations for 2021 include a potential $25 million milestone payment to the former shareholders of Rodin related to the anticipated submission of an investigational new drug application, or equivalent, for ALKS 1140, the first clinical candidate to emerge from the histone deacetylase (HDAC) inhibitor platform acquired by the company in late 2019.

 

Recent Events:

LYBALVI (formerly referred to as ALKS 3831)

Nemvaleukin alfa (“nemvaleukin”, formerly referred to as ALKS 4230)

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HDAC-inhibitor platform

Other

Corporate

 

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 11, 2021, 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 will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Thursday, Feb. 11, 2021, through Thursday, Feb. 18, 2021, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13715619.

 

About Alkermes plc

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has 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 Alkermes’ website at www.alkermes.com.

 

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Non-GAAP Financial Measures

This press release includes information about certain financial measures that are not prepared in accordance with GAAP, including non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share. 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 (loss) adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

 

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 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 (loss) and non-GAAP basic and diluted earnings (loss) per share 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 (loss) and non-GAAP basic and diluted earnings (loss) per share should not be considered measures of our 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 future financial and operating performance, business plans or prospects, including the expected drivers of future value creation, expectations of revenue growth and diversification of the company’s commercial portfolio and the anticipated improvement in patient access to healthcare providers and to the company’s commercial products; the company’s ability to execute on its strategic priorities and plans to manage for long-term profitability through execution of its Value Enhancement Plan, including through the achievement of multi-year profitability targets, review and optimization of its cost structure and potential monetization of non-core assets; the potential therapeutic and commercial value of the company’s marketed and development products; the FDA’s target PDUFA action date for, and potential approval of, the NDA for LYBALVI; expectations concerning future development activities, including advancement of the nemvaleukin development program and the anticipated submission of an IND or equivalent for ALKS 1140 and plans to initiate related studies; and expectations concerning the company’s commercial activities, including investments to support the anticipated launch of LYBALVI. 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: the company’s cost structure review and optimization may not yield the intended results; the company may not be able to achieve its targeted profitability metrics in a timely manner or at all; 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, including impacts on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia and on patient and healthcare provider access to the company’s commercial products and impacts on the regulatory agencies with which the company interacts in the development, review, approval and commercialization of its medicines; the unfavorable outcome of litigation, including so-called “Paragraph IV” litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to

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competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and the adequacy of the data and other information included in our submissions to support the FDA’s requirements for approval; 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 or of results in subsequent trials, and preliminary or interim results of the company’s development activities may not be predictive of final results of such activities, results of future preclinical or clinical trials or real-world results; regulatory submissions may not occur or be submitted in a timely manner;  the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products, such as decisions not to approve the company’s NDAs, including the NDA for LYBALVI; the company and its licensees may not be able to continue to successfully commercialize their 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 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. 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^® and ARISTADA INITIO^® are registered trademarks of Alkermes Pharma Ireland Limited; LYBALVITM is a trademark of Alkermes Pharma Ireland Limited; RISPERDAL CONSTA^®, INVEGA SUSTENNA^®, XEPLION^®, INVEGA TRINZA^® and TREVICTA^® are registered trademarks of Johnson & Johnson; and VUMERITY^® is a registered trademark of Biogen Inc., used by Alkermes under license.

 

(tables follow)

 

 

 

 

 

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Fourth Quarter and Year-End 2020 Financial Results & Business Update February 11, 2021 Exhibit 99.2

Forward-Looking Statements and Non-GAAP Financial Information 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 future financial and operating performance, business plans or prospects, including potential growth of revenue from its commercial products, potential diversification of its product portfolio, therapeutic areas that the company may pursue and the company’s plans to manage for growth and long-term profitability through execution of its Value Enhancement Plan, including its commitment to profitability targets, optimization of its cost structure and exploration of strategic opportunities; the potential therapeutic and commercial value of the company’s marketed and development products; the company’s expectations and assumptions regarding the future impacts of COVID-19 on its business; the company’s timelines, plans and expectations for development activities relating to the company’s products and product development candidates in both neuroscience and oncology, including (i) for nemvaleukin alfa (“nemvaleukin”), plans to initiate additional studies with IV nemvaleukin, select additional tumor types to pursue, and explore strategic collaborations and (ii) for ALKS 1140, plans to begin phase 1 first-in-human trials; and the company’s expectations concerning future regulatory activities and interactions, including expected timing of the U.S. Food and Drug Administration’s (“FDA”) target Prescription Drug User Fee Act (“PDUFA”) action date for the new drug application (“NDA”) for LYBALVITM and plans to advance discussions on registration plans for nemvaleukin with regulatory agencies. 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: 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 and other patent litigation, related to any of the company’s products, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than the company interprets it; the FDA may not agree with the company’s regulatory approval strategies or components of the company’s NDAs, 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 the FDA’s requirements for approval; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products, including with respect to the NDA for LYBALVI; the company’s 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 or of results in subsequent trials, and preliminary or interim results of the company’s development activities may not be predictive of final results of such activities, results of future preclinical or clinical trials or real-world results; the company and its licensees may not be able to successfully commercialize their 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. Non-GAAP Financial Measures: This presentation 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 non-GAAP earnings per share. 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. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the Alkermes plc Current Report on Form 8-K filed with the SEC on Feb. 11, 2021. Note Regarding Trademarks: The company is the owner of various U.S. federal trademark registrations (®) and other trademarks (TM), including ARISTADA®, ARISTADA INITIO® , LYBALVITM and VIVITROL®. 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

Introduction Sandy Coombs, VP, Investor Relations Corporate Update Richard Pops, Chief Executive Officer Q4 & FY 2020 Financial Results; 2021 Financial Expectations Iain Brown, Chief Financial Officer Q4 & FY 2020 Commercial Review Todd Nichols, Chief Commercial Officer R&D Pipeline Update Richard Pops, Chief Executive Officer Agenda

Execution Against Our Strategic Priorities Commercial Execution VIVITROL® and ARISTADA® Strong performance in a complex environment Adapted commercial strategy in response to COVID-19 Prepared for synergistic launch of LYBALVI™ (ALKS 3831) within psychiatry portfolio Supported launch of VUMERITY® Advancement of Highest Potential R&D Programs Completed successful Advisory Committee meeting for LYBALVI* Advanced nemvaleukin alfa (ALKS 4230) development program Observed anti-tumor activity in monotherapy and combination settings with intravenous administration Accelerated patient enrollment and expanded clinical trial network globally Nominated first clinical candidate from HDAC** inhibitor program Efficient Management of Operating Structure and Strong Governance Adapted cost structure in response to COVID-19-related disruptions Announced Value Enhancement Plan Commitment to profitability targets Focus on strategic opportunities Continued Board refreshment Appointed two new independent directors Announced upcoming retirement of two long-serving directors 2020 Key Accomplishments *NDA resubmission under review following FDA Complete Response Letter and records requests relating to manufacturing of LYBALVI. **HDAC: histone deacetylase 4

Focus on Value Creation in 2021: Three Key Components Grow and Diversify Commercial Revenues Demonstrate Value of R&D Investments Manage for Growth & Long-Term Profitability Drive VIVITROL® and ARISTADA® net sales Support VUMERITY® growth Launch LYBALVI™ (PDUFA* June 1, 2021) Nemvaleukin alfa Determine registration pathway Demonstrate anti-tumor activity Explore strategic collaboration ALKS 1140 (CoREST**-selective HDAC inhibitor) Initiate phase 1/FIH study Investor Day Provide update on pipeline platforms and programs Operationalize commitment to profitability targets Optimize cost structure and drive operating leverage Explore strategic opportunities to maximize value and enhance profitability 1 2 3 *Prescription Drug User Fee Act **Co-repressor of repressor element-1 silencing transcription factor 5

Full-Year 2020 Financial Results Summary 6 In millions In millions In millions Represents $150.0 million milestone payment from Biogen related to FDA approval of VUMERITY® in Q4 2019. ($37.8)* $1,020.9* *Amount excludes $150.0 million milestone payment from Biogen.

Fourth Quarter 2020 Revenue Summary 7 Amounts in the table above do not sum due to rounding. *Decrease in VIVITROL net sales in Q4 ‘20 was primarily due to COVID-19 pandemic-related disruptions. †Includes $5.2M of the $150M milestone payment from Biogen related to FDA approval of VUMERITY® recorded as R&D revenue. ‡Includes $144.8M of the $150M milestone payment from Biogen related to FDA approval of VUMERITY recorded as license revenue.

2020 Revenue Summary 8 *Decrease in VIVITROL net sales in FY 2020 was primarily due to COVID-19 pandemic-related disruptions. †Includes $5.2M of the $150M milestone payment from Biogen related to FDA approval of VUMERITY® recorded as R&D revenue. ‡Includes $144.8M of the $150M milestone payment from Biogen related to FDA approval of VUMERITY recorded as license revenue. Amounts in the table above do not sum due to rounding.

9 † These expectations are provided by Alkermes plc (the “Company”) in its Current Report on Form 8-K filed with the SEC on Feb. 11, 2021 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. * Ranges provided are based on recent trends and assume continuation of such trends into the first half of the year, and an anticipated improvement in patient access to treatment providers and to the Company’s commercial products in the second half of the year. If patient access does not improve as anticipated, or if new COVID-19-related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted. ‡ Non-GAAP net income adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization expense; depreciation expense; non-cash net interest expense; change in the fair value of contingent consideration; the income tax effect of these reconciling items; and certain other one-time or non-cash items. Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Company’s Current Report on Form 8-K filed with the SEC on Feb. 11, 2021. + Pending approval. PDUFA target action date is June 1, 2021. Expected net sales of proprietary products: VIVITROL® net sales of $315M – $345M† ARISTADA® net sales of $260M – $290M LYBALVI™ net sales of <$10M+ Operating expenses: R&D expense includes $25M potential milestone payment related to ALKS 1140 Alkermes: 2021 Financial Expectations†*

VIVITROL® Performance and Expectations FY’20 year-over-year net sales decline of 7% to $310.7M, driven by unit decline of 8% Gross-to-net deductions: 50% in FY’20, compared to 48% in FY’19 Minimal inventory build of approximately $1.5M in Q4’20 FY’21 net sales expected to range from $315M - $345M* Expected gross-to-net deductions: 54% Q1’21 net sales expected to be $65M - $70M VIVITROL Quarterly Net Sales ($M) 10 * These expectations are provided by the Company in its Current Report on Form 8-K filed with the SEC on Feb. 11, 2021 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. These expectations are provided based on recent trends and assume continuation of such trends into the first half of the year and an anticipated improvement in patient access to treatment providers and to the Company’s commercial products in the second half of the year. If patient access does not improve as anticipated, or if new COVID-19-related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted.

ARISTADA® Performance and Expectations FY’20 year-over-year net sales growth of 27% to $241.0M, driven by unit growth of 30% Gross-to-net deductions: 53% in FY’20, compared to 49% in FY’19 Inventory levels increased by approximately $5.2M in Q4’20 FY’21 net sales expected to range from $260M - $290M † Expected gross-to-net deductions: 55% Q1’21 net sales expected to be $50M - $55M ARISTADA Quarterly Net Sales ($M)* 11 *Inclusive of ARISTADA INITIO® † These expectations are provided by the Company in its Current Report on Form 8-K filed with the SEC on Feb. 11, 2021 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. These expectations are provided based on recent trends and assume continuation of such trends into the first half of the year and an anticipated improvement in patient access to treatment providers and to the Company’s commercial products in the second half of the year. If patient access does not improve as anticipated, or if new COVID-19-related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted.

ARISTADA®: Prescription Growth Trends Q4 year-over-year growth of 16% on TRx months of therapy (MOT) basis Outpaced overall atypical long-acting injectable (LAI) market Q4 year-over-year growth of 5% Market share: TRx MOT: 9.1% of atypical LAI market prescriptions in Q4 ‘20 ARISTADA Quarterly TRx MOT Source: IQVIA NPA 12

Advancing Neuroscience Development Programs Daily oral investigational antipsychotic designed to offer efficacy of olanzapine; addition of samidorphan intended to mitigate olanzapine-associated weight gain NDA resubmission and response to records request under review by FDA; PDUFA date June 1, 2021 Novel investigational CoREST-selective HDAC inhibitor First-in-human trials expected to begin in 2021 Initial clinical development plans focused on basket of indications, including rare neurodegenerative and neurodevelopmental diseases as well as common psychiatric diseases 13 ALKS 1140 TM*

Nemvaleukin Development Strategy Demonstrate pharmacodynamic response Initiate phase 2 expansion stage Demonstrate monotherapy anti-tumor activity* Demonstrate anti-tumor activity in combination with PD-1 inhibitor* Select initial tumor types to pursue for registration of IV nemvaleukin Advance discussions on registration plans with regulators Initiate studies Identify and select additional tumor types, combinations to pursue Strategic collaboration CONFIRM mechanism through immune response SEEK anti-tumor activity signals FOCUS on initial registration pathways BROADEN program to maximize value 14 *Anti-tumor activity observed in ARTISTRY-1 evaluating nemvaleukin administered intravenously.

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