Alkermes plc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-K

(Mark One)

for the fiscal year ended December 31,2025

OR

For the transition period from to

Commission file number:001-35299

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

+353-1-772-8000

(Registrant’s telephone number, including area code)

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

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No☐

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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.☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes☐ No☒

The aggregate market value of the registrant’s ordinary shares held by non-affiliates of the registrant (without admitting that any person whose shares are not included in such calculation is an affiliate) computed by reference to the price at which the ordinary shares were last sold as of the last business day of the registrant’s most recently completed second fiscal quarter was $4,657,775,005.

As of February 20, 2026,166,649,934 ordinary shares were outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the definitive proxy statement for our 2026 Annual General Meeting of Shareholders are incorporated by reference into Part III of this report.

ALKERMES PLC AND

SUBSIDIARIES

ANNUAL REPORT ON FORM 10-K

FOR THE YEAR ENDED DECEMBER 31, 2025

INDEX

CAUTIONARY NOTE CONCERNING FORWARD-LOOKING STATEMENTS

This document contains and incorporates by reference “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). 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 Annual Report on Form 10-K (this “Annual Report”) may include, without limitation, statements regarding:

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our expectations regarding our financial performance, including revenues, expenses, liquidity, capital expenditures, income taxes and profitability;

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our expectations regarding our products, including expectations related to product development; regulatory exclusivities, filings, approvals and timelines; therapeutic and commercial value, scope and potential; and the costs and expenses related to such activities and expectations;

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our expectations regarding the timing, design and results of clinical trials of our products;

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our expectations regarding the competitive, payer, legislative, regulatory and policy landscape, and changes therein, related to our products, including competition from generic forms of our products or competitive products and development programs; barriers to access or coverage of our products and potential changes in reimbursement of our products; and legislation, regulations, executive orders, guidance or other measures that may impact pricing and reimbursement of, and access to, our products;

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our expectations regarding the financial impact of currency exchange rate fluctuations and valuations;

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our expectations regarding acquisitions, collaborations, licensing arrangements and other significant agreements with third parties, including those related to our products, development programs, and other business development opportunities;

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our expectations regarding the impacts of new legislation, rules and regulations, the adoption of new accounting pronouncements, government shutdowns, or other global, political or economic changes, instability or disruptions;

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our expectations regarding near-term changes in the nature of our market risk exposures or in our management’s objectives and strategies with respect to managing such exposures;

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our expectations regarding our ability to comply with restrictive covenants of our indebtedness and our ability to fund our debt service obligations;

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our expectations regarding future capital requirements and expenditures for our operations and our ability to finance such capital requirements and expenditures;

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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, know-how, and related rights or obligations;

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our expectations regarding the Avadel Acquisition (as defined below), including any anticipated benefits and synergies of the transaction;

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our expectations regarding the tax treatment and other anticipated benefits of the completed separation of our oncology business; and

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other expectations discussed elsewhere in this Annual 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 expectations discussed in this Annual Report might not occur. You are cautioned not to place undue reliance on the forward-looking statements in this Annual Report, which speak only as of the date of this Annual Report. All subsequent written and oral forward-looking statements concerning the matters addressed in this Annual 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 information about the risks, assumptions and uncertainties of our business, see “Item 1A—Risk Factors” in this Annual Report.

This Annual Report may include 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. While we believe that any industry publications and third-party research, surveys and studies from which data is included in this Annual Report are reliable, we have not independently verified any such data. This Annual Report may also include data based on our own internal estimates and research. Our internal estimates and research have not been verified by any independent source and are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Item 1A—Risk Factors” in this Annual Report. These and other factors could cause our results to differ materially from those expressed or implied in this Annual Report.

Summary of Material Risks Associated with Our Business

Our business is subject to numerous material and other risks and uncertainties that you should be aware of. These risks and uncertainties are described more fully in “Item 1A—Risk Factors” in this Annual Report, and include, but are not limited to, the following:

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we receive substantial revenue from our key proprietary products, and our success depends on our ability to successfully manufacture and commercialize such products;

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we face competition in the biopharmaceutical industry;

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our revenues from sales of our products may decrease or grow at a slower than expected rate due to many factors;

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revenues generated by sales of our products depend, in part, on the availability from third-party payers of reimbursement for our products and the extent of cost-sharing arrangements for patients (e.g., patient co-payment, co-insurance, deductible obligations) and cost-control measures imposed, and any reductions in payment rate or reimbursement or increases in our or in patients’ financial obligation to payers could result in decreased sales of our products and/or decreased revenues;

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we may fail to realize some or all of the anticipated benefits and synergies of the Avadel Acquisition or to successfully integrate Avadel’s business, which could adversely affect our business and financial condition and the price of our ordinary shares;

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if there are changes in, or we fail to comply with, the extensive legal and regulatory requirements affecting the healthcare industry, we could be subject to investigations, litigation, costs, penalties and business losses;

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we rely on our licensees in the commercialization and continued development of products from which we receive revenue and, if our licensees are not effective, or if disputes arise in respect of our contractual arrangements, our revenues could be materially adversely affected;

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clinical trials for our product candidates are expensive, may take several years to complete, and their outcomes are uncertain;

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preliminary, topline or interim data from our clinical trials that we may announce, publish or report from time to time may change as more patient data become available or based on subsequent audit and verification procedures, and may not be indicative of final data from such trials, data from future trials or real-world results;

•

our success depends, in part, on our ability to successfully obtain and maintain regulatory approval for our products;

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disruptions at the United States (“U.S.”) Food and Drug Administration (the “FDA”), the U.S. Securities and Exchange Commission (“SEC”) and other government agencies could negatively impact our business;

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we may not be able to successfully expand our research and development (“R&D”) pipeline or our commercial product portfolio, which could limit our growth potential;

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we are subject to risks related to the manufacture of our products;

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we rely on third parties to provide goods and services in connection with the manufacture and distribution of our products;

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LUMRYZ is a controlled substance subject to U.S. federal and state-controlled substance laws and regulations, and any failure to comply with these laws and regulations, or the cost of compliance with these laws and regulations, could materially adversely affect our business, financial condition, cash flows and results of operations;

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our success largely depends upon our ability to attract, recognize and retain key personnel, and the loss of key personnel may materially and adversely impact our business;

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patent and other IP protection for our products is key to our business and our competitive position but is uncertain;

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uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we and our licensees have previously and may in the future face claims against IP rights covering our products and competition from generic drug manufacturers;

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litigation or arbitration filed against us, including securities litigation, or actions (such as citizens petitions) filed against regulatory agencies in respect of our products, may result in financial losses, harm our reputation, divert management resources, negatively impact the approval of our products, or otherwise negatively impact our business;

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we may not be able to maintain profitability on a sustained basis;

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the U.S. Internal Revenue Service (“IRS”) may not agree with our conclusion that we should be treated as a foreign corporation for U.S. federal income tax purposes;

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if the separation of our oncology business completed in November 2023 does not ultimately qualify as a transaction that is generally tax-free for U.S. federal and Irish tax purposes as we anticipate, we and/or our shareholders could be subject to significant tax liabilities;

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our debt obligations could adversely affect our business and limit our ability to plan for or respond to changes in our business;

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the market price of our ordinary shares has been volatile and may continue to be volatile in the future, and could decline significantly;

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our business could be negatively affected as a result of the actions of activist shareholders;

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information security breaches and other disruptions could compromise our information and expose us to liability, which could cause our business and reputation to suffer; and

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changes in global trade or other policies, including tariffs or other restrictions imposed by the U.S. government or governments of other nations, could have an adverse effect on our business, results of operations, or financial condition.

The material and other risks and uncertainties summarized above should be read together with the text of the full risk factors in “Item 1A—Risk Factors” in this Annual Report and the other information set forth in this Annual Report, including our consolidated financial statements and the related notes, and in other documents that we file with the SEC. If any such material or other risks and uncertainties actually occur, our business, financial condition, cash flows or results of operations could be materially and adversely affected. The risks and uncertainties summarized above or described below are not the only risks and uncertainties that we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, cash flows or results of operations.

NOTE REGARDING COMPANY AND PRODUCT REFERENCES

Use of terms such as “us,” “we,” “our,” “Alkermes” or the “Company” in this Annual 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 Annual Report include our marketed products, marketed products using our proprietary technologies, our licensed products, our product candidates and product candidates using our proprietary technologies, (b) references to the “biopharmaceutical industry” in this Annual Report are intended to include reference to the “biotechnology industry” and/or the “pharmaceutical industry” and (c) references to “licensees” in this Annual Report are used interchangeably with references to “partners.”

NOTE REGARDING TRADEMARKS

We are the owner of various U.S. federal trademark registrations (“®”) and other trademarks (“TM”), including ALKERMES®, ARISTADA®, ARISTADA INITIO®, LinkeRx®, LUMRYZ®, LYBALVI®, MICROPUMP®, NanoCrystal®, and VIVITROL®.

The following are trademarks of the respective companies listed: ABILIFY®, ABILIFY ASIMTUFII®and ABILIFY MAINTENA®—Otsuka Pharmaceutical Co., Ltd. (“Otsuka Pharm. Co.”); 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; BRIXADI®—Braeburn Inc.; BRIUMVI®—TG Therapeutics, Inc.; BUNAVAILTM—BioDelivery Sciences; CAMPRAL®—Merck Sante;COPAXONE®and UZEDY®—Teva Pharmaceutical Industries Ltd. (together with its affiliates, “Teva”) ; EXTAVIA®, GILENYA®, and MAYZENT®—Novartis AG; BYANNLI®, CABENUVA®, CAPLYTA®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, PONVORY®, RISPERDAL CONSTA®, TREVICTA® and XEPLION®—Johnson & Johnson or its affiliated companies; FAMPYRATM—Merz Pharmaceuticals, LLC; MAVENCLAD®—Merck KGaA, REBIF®—Ares Trading S.A.; OCREVUS®—Genentech, Inc. (“Genentech”); REXULTI®—H. Lundbeck A/S plc; SUBOXONE®, SUBUTEX®and SUBLOCADE®—Indivior plc (or its affiliates); RYKINDO®—Luye Pharma Group; SUNOSI®—Axsome Therapeutics, Inc.; VRAYLAR®— Forest Laboratories, LLC; COBENFY® and ZEPOSIA®—Bristol-Myers Squibb Company; and WAKIX®—Harmony Biosciences Holdings, Inc.; XYWAV® and XYREM®—Jazz Pharmaceuticals plc; ZUBSOLV®—Orexo US, Inc.; and ZYPREXA®and ZYPREXA RELPREVV®—Eli Lilly and Company (“Lilly”). Other trademarks, trade names and service marks appearing in this Annual Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Annual Report are referred to without the®or ™ 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.