ALKERMES PUBLIC LIMITED COMPANY

DIRECTORS' REPORT AND CONSOLIDATED FINANCIAL STATEMENTS

For the Financial Year Ended December 31, 2020

Registered Company Number: 498284

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ALKERMES PUBLIC LIMITED COMPANY

DIRECTORS' REPORT AND CONSOLIDATED FINANCIAL STATEMENTS

TABLE OF CONTENTS

Directors' Report...................................................................................................................................................................

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Statement of Directors' Responsibilities...............................................................................................................................

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Independent Auditors' Report-Groupand Company.........................................................................................................

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Consolidated Profit and Loss Account..................................................................................................................................

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Consolidated Statement of Comprehensive Loss..................................................................................................................

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Consolidated Balance Sheet..................................................................................................................................................

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Consolidated Statement of Cash Flows.................................................................................................................................

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Consolidated Reconciliation of Movement in Shareholders' Funds.....................................................................................

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Notes to the Consolidated Financial Statements...................................................................................................................

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Company Balance Sheet........................................................................................................................................................

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Company Reconciliation of Movement in Shareholders' Funds..........................................................................................

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Notes to the Company Financial Statements.........................................................................................................................

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DIRECTORS' REPORT

For the Financial Year Ended December 31, 2020

The directors present their report and the audited consolidated financial statements and related notes of

Alkermes Public Limited Company ("Alkermes plc") for the year ended December 31, 2020. Irish law requires the directors to prepare financial statements for each financial year that give a true and fair view of the consolidated and company's assets, liabilities and financial position as at the end of the financial year and of the profit or loss of the group for the financial year. Under that law, the directors have prepared the consolidated financial statements in accordance with U.S. accounting standards, as defined in Section 279(1) of the Companies Act 2014, as amended (the "Companies Act"), to the extent that the use of those principles in the preparation of the financial statements does not contravene any provision of the Companies Act or of any regulations made thereunder and the parent company financial statements in accordance with generally accepted accounting practice in Ireland (accounting standards issued by the Financial Reporting Council and Irish law).

NOTE REGARDING COMPANY AND PRODUCT REFERENCES

Use of terms such as "us," "we," "our," "Alkermes" or the "Company" in this Directors' Report is meant to refer to Alkermes plc and its consolidated subsidiaries. Except as otherwise suggested by the context, (a) references to "products" or "our products" in this Directors' Report include our marketed products, marketed products using our proprietary technologies, our product candidates and product candidates using our proprietary technologies (b) references to the "biopharmaceutical industry" in this Directors' Report are intended to include reference to the "biotechnology industry" and/or the "pharmaceutical industry" and (c) references to "licensees" in this Directors' Report are used interchangeably with references to "partners."

NOTE REGARDING TRADEMARKS

We are the owner of various United States ("U.S.") federal trademark registrations ("®") and other trademarks ("TM"), including ALKERMES®, ARISTADA®, ARISTADA INITIO®, LinkeRx®, LYBALVITM, NanoCrystal®, and VIVITROL®.

The following are trademarks of the respective companies listed: ABILIFY® and ABILIFY MAINTENA®-Otsuka Pharmaceutical Co., Ltd. ("Otsuka Pharm. Co."); AMPYRA® and FAMPYRA®-Acorda Therapeutics, Inc. ("Acorda"); ANTABUSE®-Teva Women's Health, Inc.; AUBAGIO® and LEMTRADA®-Sanofi Societe Anonyme France; AVONEX®, PLEGRIDY®, TECFIDERA®, TYSABRI® and VUMERITY®-Biogen MA Inc. (together with its affiliates, "Biogen"); BETASERON®-Bayer Pharma AG; BUNAVAILTM-BioDelivery Sciences; CAMPRAL®-Merck Sante; CAPLYTA®-Intra-Cellular Therapies, Inc.; COPAXONE®-Teva Pharmaceutical Industries Ltd.; EXTAVIA®, GILENYA®, and MAYZENT®-Novartis AG; INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA®, XEPLION® and RISPERDAL CONSTA®-Johnson & Johnson (or its affiliates); LATUDA®- Sumitomo Dainippon Pharma Co., Ltd.; MAVENCLAD®-Merck KGaA, REBIF®-Ares Trading S.A.; OCREVUS®-Genentech, Inc. ("Genentech"); REXULTI®- H. Lundbeck A/S plc; PERSERIS®, SUBOXONE®, SUBUTEX® and SUBLOCADE®-Indivior plc (or its affiliates); VRAYLAR®- Forest Laboratories, LLC; ZEPOSIA®-Bristol-Myers Squibb Company; ZUBSOLV®-Orexo US, Inc.; and ZYPREXA® and ZYPREXA RELPREVV®-Eli Lilly and Company ("Lilly"). Other trademarks, trade names and service marks appearing in this Directors' Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Directors' Report are referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

CAUTIONARY NOTE CONCERNING FORWARD-LOOKING STATEMENTS

This document contains and incorporates by reference "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, these statements can be identified by the use of forward-looking terminology such as "may," "will," "could," "should," "would," "expect," "anticipate," "continue," "believe," "plan," "estimate," "intend," or other similar words. These statements discuss future expectations and contain projections of results of operations or of financial condition, or state trends and known uncertainties or other forward-looking information. Forward-looking statements in this Directors' Report include, without limitation, statements regarding:

  • our expectations regarding our financial performance, including revenues, expenses, liquidity, capital expenditures and income taxes;
  • our expectations regarding our products, including those expectations related to product development, regulatory filings, regulatory approvals and regulatory timelines, therapeutic and commercial scope and potential, and the costs and expenses related to such activities;
  • our expectations regarding the initiation, timing and results of clinical trials of our products;

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  • our expectations regarding the competitive, payer, legislative, regulatory and policy landscapes, and changes therein, related to our products, including competition from generic forms of our products or competitive products and competitive development programs, barriers to access or coverage of our products and changes in reimbursement of our products, and legislation, regulations, executive orders, guidance or other measures that may limit pricing and reimbursement of, and access to, our products;
  • our expectations regarding the financial impact of currency exchange rate fluctuations and valuations;
  • our expectations regarding future amortization of intangible assets;
  • our expectations regarding our collaborations, licensing arrangements and other significant agreements with third parties relating to our products, including our development programs;
  • our expectations regarding the impact of new legislation, rules, regulations and the adoption of new accounting pronouncements;
  • our expectations regarding near-term changes in the nature of our market risk exposures or in management's objectives and strategies with respect to managing such exposures;
  • our expectations regarding our ability to comply with restrictive covenants of our indebtedness and our ability to fund our debt service obligations;
  • our expectations regarding future capital requirements and capital expenditures and our ability to finance our operations and capital requirements;
  • our expectations regarding the timing, outcome and impact of administrative, regulatory, legal and other proceedings related to our products and intellectual property ("IP"), including our patents;
  • our expectations regarding the impact of the ongoing novel coronavirus ("COVID-19") pandemic on our business and operations; and
  • other factors discussed elsewhere in this Directors' Report.

Actual results might differ materially from those expressed or implied by these forward-looking statements because these forward-looking statements are subject to risks, assumptions and uncertainties. In light of these risks, assumptions and uncertainties, the forward-looking events discussed in this Directors' Report might not occur. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Directors' Report. All subsequent written and oral forward-looking statements concerning the matters addressed in this Directors' Report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Except as required by applicable law or regulation, we do not undertake any obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For more information regarding the risks, assumptions and uncertainties of our business, see the "Principal Risks" section of this Directors' Report.

This Directors' Report includes data that we obtained from industry publications and third-party research, surveys and studies. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. This Directors' Report also includes data based on our own internal estimates and research. Our internal estimates and research have not been verified by any independent source, and, while we believe the industry publications and third-party research, surveys and studies are reliable, we have not independently verified such data. Such third-party data and our internal estimates and research are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the "Principal Risks" section of this Directors' Report. These and other factors could cause results to differ materially from those expressed in this Directors' Report.

Principal Activities

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research

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and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

COVID-19 Update

In March 2020, COVID-19 was declared a global pandemic by the World Health Organization. To date, COVID-19 has surfaced in nearly all regions around the world and resulted in travel restrictions and business slowdowns and/or shutdowns in affected areas. All U.S. states, and many local jurisdictions and countries around the world, including Ireland, have, at times during the pandemic, issued "shelter-in-place" orders, quarantines, executive orders and similar government orders, restrictions, and recommendations for their residents to control the spread of COVID-19. Such orders, restrictions and/or recommendations, and/or the perception that additional orders, restrictions or recommendations could occur, have resulted in widespread closures of businesses, including healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia, work stoppages, slowdowns and/or delays, work-from-home policies and travel restrictions, among other effects.

We continue to closely monitor and rapidly respond to the ongoing impact of COVID-19 on our employees, our

communities and our business operations. We have adopted a series of precautionary measures and will continue to do so as the circumstances warrant, in an effort to protect our employees and mitigate the potential spread of COVID-19 in a community setting. For example, we instituted a global remote work policy for those of our employees who are able to work remotely. Certain of our field-based employees have since resumed in-person interactions, as appropriate and on a voluntary basis, in accordance with location-specific guidance.

At the same time, we have worked to continue our critical business functions, including continued operation of our manufacturing facilities and our laboratories, and have continued to conduct our discovery efforts and supply our medicines. For those of our employees who work in our manufacturing facilities and laboratories or who otherwise enter any of our sites, we have instituted, and will continue to institute as we deem appropriate and as required, additional safety precautions, including increased sanitization of our facilities, use of personal protective equipment, implementation of a daily health screening application and physical distancing practices to help protect their health and safety. We have also taken actions to support people living with schizophrenia, opioid dependence and alcohol dependence to help assure that they have access to the information, resources and medicines that may assist in their treatment.

The marketed products from which we derive revenue, including manufacturing and royalty revenue, are primarily injectable medications administered by healthcare professionals. Given developments that have transpired to date, and may continue to transpire, in response to the pandemic, including the implementation of "shelter-in-place" policies, social distancing requirements and other restrictive measures, commercial sales of these marketed products have been adversely impacted to varying degrees and we expect commercial sales of these marketed products to continue to be adversely impacted while the pandemic persists.

During the year ended December 31, 2020, we took actions to support uninterrupted access to our proprietary marketed products. However, we currently expect commercial sales of our marketed products, particularly VIVITROL, to be impacted by the COVID-19 pandemic into 2021. The impact COVID-19 had on our proprietary marketed products during the year ended December 31, 2020 is discussed in greater detail later in the "Results of Operations" section of this Directors' Report.

While we continue to conduct R&D activities, including our ongoing clinical trials, the COVID-19 pandemic has impacted, and may continue to impact, the timelines of certain of our early-stage discovery efforts and clinical trials. We are working with our internal teams, our clinical investigators, R&D vendors and critical supply chain vendors to continually assess, and mitigate, the potential impact of COVID-19 on our manufacturing operations and R&D activities.

Due to numerous uncertainties surrounding the ongoing COVID-19 pandemic, the actual impact on our financial condition and operating results resulting from the pandemic may differ from our current projections. These uncertainties include, among other things, the ultimate severity and duration of the pandemic; governmental, business or other actions that have been, are being, or will be, taken in response to the pandemic, including restrictions on travel and mobility, business closures and operating restrictions and imposition of social distancing measures; impacts of the pandemic on our employees, the vendors or distribution channels in our supply chain and on our ability to continue to manufacture our products; impacts of the pandemic on the conduct of our clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites, and monitoring of data; impacts of the pandemic on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia; impacts of the pandemic on the regulatory agencies with which we interact in the development, review, approval and commercialization of our medicines; impacts of the pandemic on reimbursement for our products, including our Medicaid rebate liability, and for services related to the use of our products; and impacts of the pandemic on the U.S., Irish and global economies more broadly. For additional information about risks

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Alkermes plc published this content on 14 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 April 2021 18:04:05 UTC.