What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-02-25 compared with 2025-02-12 · 160 added, 75 removed, 664 unchanged (26% of the section changed)

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Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience.

We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia.

We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for neurological disorders.

Headquartered in Ireland, we also have a corporate office and R&D center in Massachusetts and a manufacturing facility in Ohio.

In October 2025, we and Avadel Pharmaceuticals plc (“Avadel”) entered into a definitive transaction agreement, subsequently amended in November 2025 (the “Transaction Agreement”), pursuant to which we agreed to acquire the entire issued and to be issued ordinary share capital of Avadel for consideration of (i) $21.00 per ordinary share, nominal value $0.01 per share, of Avadel (each, an “Avadel Share”), payable in cash at closing and (ii) a non-transferable contingent value right (the “CVR”) entitling holders of Avadel Shares to a potential additional cash payment of $1.50 per Avadel Share, contingent upon achievement of a certain specified milestone (the “Avadel Acquisition”).

On February 12, 2026, we successfully completed the Avadel Acquisition, adding both LUMRYZ to our portfolio of proprietary commercial products and a commercial organization with experience in narcolepsy.

Marketed Products

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Proprietary Products

Indication(s)

Indicated Disease State

Initiation or re-initiation of

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Key Third-Party Products Using Our Proprietary Technologies

Indication(s)

Indicated Disease State

Licensed Territory

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Our Key Licensed Product

Indication(s)

Indicated Disease State

Licensed Territory

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We exclusively manufacture and commercialize ARISTADA INITIO in the U.S.

In December 2024, U.S.

12,180,164 relating to ARISTADA and ARISTADA INITIO was granted.

The patent has claims to the metabolite N-hydroxymethyl aripiprazole and expires in 2030.

What is schizophrenia?

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Schizophrenia affects approximately 1.1% of the U.S.

LUMRYZ (sodium oxybate) is an extended-release oral suspension product approved by the FDA in May 2023 as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (“EDS”) in adults with narcolepsy, and subsequently approved by the FDA in October 2024 as a once-at-bedtime treatment for cataplexy or EDS in pediatric patients seven years of age and older with narcolepsy.

The FDA has granted seven years of orphan drug exclusivity (“ODE”) to LUMRYZ for the adult and pediatric narcolepsy patient populations through May 1, 2030 and October 16, 2031, respectively.

We exclusively commercialize LUMRYZ in the U.S.

Pursuant to the settlement and license agreement entered into between Jazz and Avadel in October 2025 (the “Avadel Settlement Agreement”), from October 1, 2025, Jazz receives a royalty of 3.85% (subject to certain adjustments set forth in the agreement) on net sales of LUMRYZ sold for narcolepsy and additional royalties on net sales of LUMRYZ sold for any other future FDA-approved non-narcolepsy indications.

For more information about the agreement and underlying royalty obligations, see “Patents and Proprietary Rights – LUMRYZ” in “Item 1— Business” of this Annual Report.

LUMRYZ employs a version of our MICROPUMP technology.

LUMRYZ is manufactured by third parties.

The FDA has required implementation of a REMS for LUMRYZ to help ensure the benefits of the drug outweigh any risks of serious adverse outcomes that may result from inappropriate prescribing, misuse, abuse or diversion of the product.

Under the LUMRYZ REMS, healthcare providers who prescribe the drug must be specially certified, pharmacies that dispense the drug must be specially certified, and the drug must be dispensed only to patients who have enrolled in the LUMRYZ REMS and completed all REMS requirements, including documentation of safe use conditions.

What is narcolepsy?

Narcolepsy is a chronic, neurological disorder that affects the brain’s ability to regulate the sleep-wake cycle.

The hallmark symptom of narcolepsy is excessive daytime sleepiness;

additional symptoms can include sleep paralysis, disturbed nighttime sleep and sleep-related hallucinations.

There are two types of narcolepsy:

narcolepsy type 1 (“NT1”) is characterized by the loss of orexin-producing neurons and is also associated with cataplexy, a sudden loss of muscle control.

Narcolepsy type 2 (“NT2”) shares symptoms with NT1, but is not associated with cataplexy.

An estimated 100,000 people in the U.S.

are diagnosed with narcolepsy.

LYBALVI (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S.

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We exclusively manufacture and commercialize LYBALVI in the U.S.

In January 2025, U.S.

12,194,035 relating to LYBALVI was granted.

The patent has claims to methods of treatment that cover LYBALVI and expires in 2031.

For a discussion of legal proceedings related to LYBALVI, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in this Annual Report, and specifically the section entitled “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.”

What is schizophrenia?

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We exclusively manufacture and commercialize VIVITROL in the U.S.

For a discussion of legal proceedings related to VIVITROL, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report, and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in this Annual Report, and specifically the sections entitled “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” and “Litigation or arbitration filed against Alkermes, 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.”

What are opioid dependence and alcohol dependence?

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In determining the applicability of treatments for DSM-IV conditions to persons diagnosed according to DSM-5, one study found agreement between the DSM-IV diagnoses of alcohol dependence and opioid dependence and moderate to severe alcohol use disorder and opioid use disorder, respectively, under DSM-5.

Licensed Products and Products Using Our Proprietary Technologies

It was noted in the opioid use disorder table of the 2024 U.S.

National Survey on Drug Use and Health that certain estimates for 2024 may differ from previously published estimates due to changes in how opioids were defined beginning in 2024.

Products Using Our Proprietary Technologies and Licensed Product

We have licensed products to third parties for commercialization and have licensed our proprietary technologies to third parties to enable them to develop, commercialize and/or manufacture products.

See the section entitled “ Proprietary Technology Platforms ” and “ Patents and Proprietary Rights ” in “Item 1—Business” in this Annual Report for information with respect to our proprietary technologies and the IP protection for these products.

See the sections entitled “ Proprietary Technology Platforms ” and “ Patents and Proprietary Rights ” in “Item 1—Business” in this Annual Report for information with respect to our proprietary technologies and the IP protection for these products.

We receive royalties and/or manufacturing and other revenues from the commercialization of these products under our collaborative arrangements with these third parties.

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INVEGA HAFYERA/BYANNLI is manufactured by Janssen.

For a discussion of legal proceedings related to certain of the patents covering INVEGA TRINZA, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report and for information about risks relating to such legal proceedings, see “Item 1A—Risk Factors” in this Annual Report and specifically the section entitled “Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”

What is schizophrenia?

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Under our license and collaboration agreement with Biogen, Biogen holds the exclusive, worldwide license to develop and commercialize VUMERITY.

For more information about the license and collaboration agreement with Biogen, see the section entitled “ Collaborative Arrangements—Biogen ” in “Item 1—Business” in this Annual Report.

For a discussion of legal proceedings related to certain of the patents covering VUMERITY, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report and for information about risks relating to such legal proceedings, see “Item 1A—Risk Factors” in this Annual Report and specifically the section entitled “Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”

For more information about the license and collaboration agreement with Biogen, see the “Collaborative Arrangements—Biogen” section in “Part I, Item 1—Business” in this Annual Report.

What is multiple sclerosis?

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Approximately 2.5 million people worldwide have MS, and most are diagnosed between the ages of 15 and 50.

Key Development Program

Key Development Programs

Our R&D is focused on the development of innovative medicines in the field of neuroscience that are designed to address unmet patient needs.

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See the section entitled “ Patents and Proprietary Rights ” in “Item 1—Business” in this Annual Report for information with respect to the IP protection for our key development program.

ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor agonist in development as a once-daily treatment for narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia.

Alixorexton (formerly referred to as ALKS 2680)

Alixorexton is a novel, investigational, oral, selective orexin 2 receptor agonist in development for the treatment of NT1, NT2 and idiopathic hypersomnia (“IH”).

Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain.

Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease.

Once-daily oral administration of ALKS 2680 was previously evaluated in a phase 1 study in healthy volunteers and patients with narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia and is currently being evaluated in two phase 2 studies:

Vibrance-1 in patients with narcolepsy type 1 and Vibrance-2 in patients with narcolepsy type 2.

We expect to initiate Vibrance-3, a phase 2 study in patients with idiopathic hypersomnia, in the first half of 2025.

Once-daily oral administration of alixorexton was previously evaluated in a phase 1 study in healthy volunteers and patients with NT1, NT2 and IH.

In 2025, we completed, and announced positive topline data from, two phase 2 studies, Vibrance-1 and Vibrance-2, in patients with NT1 and NT2, respectively.

We plan to initiate a phase 3 program in narcolepsy in the first quarter of 2026.

Alixorexton is also currently being evaluated in Vibrance-3, a phase 2 study in patients with IH.

In December 2025, the FDA granted Breakthrough Therapy designation to alixorexton for the treatment of NT1.

LUMRYZ (sodium oxybate)

LUMRYZ (sodium oxybate) extended-release oral suspension is currently being evaluated in REVITALYZ, a double-blind, placebo-controlled, randomized withdrawal, multicenter phase 3 study designed to evaluate efficacy and safety in adult patients with IH.

In December 2025, patient enrollment in REVITALYZ was completed.

Collaborative Arrangements

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There are no further milestones to be earned under this agreement.

The agreement also provides for royalty

payments, which consist of a patent royalty and a know-how royalty, both of which are determined on a country-by-country basis.

The agreement also provides for royalty payments, which consist of a patent royalty and a know-how royalty, both of which are determined on a country-by-country basis.

The patent royalty, which equals 1.5% of net sales, is payable in each country until the expiration of the last of the patents with valid claims applicable to the product in such country.

As of August 30, 2024, all patent royalties had expired.

The know-how royalty is a tiered royalty of 3.5% on calendar year net sales up to $250 million;

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Royalties for all products are subject to customary reductions, as set forth in the license and collaboration agreement.

Following FDA approval of VUMERITY and except for the manufacturing responsibilities discussed below, Biogen is now responsible for all development and commercialization activities for VUMERITY and all other products covered by the patents that we licensed to Biogen.

Following FDA approval of VUMERITY in 2019, Biogen is responsible for all development and commercialization activities for VUMERITY and all other products covered by the patents that we licensed to Biogen.

Under the license and collaboration agreement, Biogen appointed us as the toll manufacturer of clinical and commercial supplies of VUMERITY, subject to Biogen’s right to manufacture or have manufactured commercial supplies as a back-up manufacturer.

In October 2019, we entered into a commercial supply agreement with Biogen for the commercial supply of VUMERITY, an amendment to such commercial supply agreement and an amendment to the license and collaboration agreement with Biogen, pursuant to which Biogen has conducted a technology transfer and, following an agreed manufacturing transition period, has elected to assume responsibility for the manufacture (itself or through a designee) of clinical and commercial supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to us on net sales of product that is manufactured by Biogen or its designee.

In May 2024, we completed the sale of our research and development business and manufacturing facility in Athlone, Ireland (the “Athlone Facility”) where VUMERITY is manufactured.

In connection with the sale of the Athlone Facility, we have entered into a subcontracting arrangement with the purchaser of the Athlone Facility for the manufacture of VUMERITY through the manufacturing transition period, which may continue through the end of 2025.

In October 2019, we entered into a commercial supply agreement with Biogen for the commercial supply of VUMERITY, an amendment to such commercial supply agreement and an amendment to the license and collaboration agreement with Biogen, pursuant to which Biogen has, following a completed technology transfer and an agreed manufacturing transition period, assumed all responsibility for the manufacture (itself or through a designee) of clinical and commercial supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to us on net sales of product that is manufactured by Biogen or its designee.

In May 2024, we completed the sale of our research and development business and manufacturing facility in Athlone, Ireland (the “Athlone Facility”) where VUMERITY was manufactured.

In connection with the sale of the Athlone Facility, we entered into a subcontracting arrangement with the purchaser of the Athlone Facility for the manufacture of VUMERITY through the manufacturing transition period, which concluded in August 2025.

Unless earlier terminated, the license and collaboration agreement will remain in effect until the expiry of all royalty obligations.

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Our oral controlled release (“OCR”) technologies are used to formulate, develop and manufacture oral dosage forms of pharmaceutical products with varied drug release profiles.

MICROPUMP Technology

Our MICROPUMP technology allows for the development of modified release solid, oral dosage drug formulations.

Manufacturing and Product Supply

We own and occupy a manufacturing facility in Wilmington, Ohio.

We either purchase active pharmaceutical ingredient (“API”) from third parties or receive it from our third-party licensees to manufacture products using our technologies.

The manufacture of our products for clinical trials and commercial use is subject to Current Good Manufacturing Practices (“cGMP”) regulations and other regulations.

For products that we manufacture, we either purchase active pharmaceutical ingredient (“API”) from third parties or receive it from our third-party licensees.

Our manufacturing and development capabilities include formulation through process development, scale-up and full-scale commercial manufacturing and specialized capabilities for the development and manufacture of controlled substances.

We also contract with third party suppliers and contract manufacturers for the purchase of certain API or other raw materials or components of our products and for the manufacture of certain drug product.

The manufacture of our products for clinical trials and commercial use, whether by us or third parties, is subject to Current Good Manufacturing Practices (“cGMP”) regulations and other regulations.

Although some materials and related services for our products are currently only available from a single source or a limited number of qualified sources, we attempt to acquire an adequate inventory of such materials, establish alternative sources for such materials and related services and/or negotiate long-term supply arrangements.

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Any delay, interruption or other issues that arise in the acquisition of API, raw materials, or components, or in the manufacture, fill-finish, packaging, or storage of our marketed or development products, including as a result of a failure of our facilities or the facilities or operations of third parties to pass any regulatory agency inspection, could significantly impair our ability to manufacture and market our products or advance our development efforts, as the case may be.

In May 2024, we completed the sale of our Athlone Facility and related business to Novo Nordisk (“Novo”) and entered into subcontracting arrangements to continue certain development and manufacturing activities performed at the Athlone Facility for a period of time after the closing of the transaction, which may continue through the end of 2025.

For information about risks relating to the manufacture of our marketed products and product candidates, see “Item 1A—Risk Factors” in this Annual Report and specifically those sections entitled “We rely on third parties to provide goods and services in connection with the manufacture and distribution of the products we manufacture” and “We are subject to risks related to the manufacture of our products.”

For information about risks relating to the manufacture of our marketed products and product candidates, see “Item 1A—Risk Factors” in this Annual Report and specifically those sections entitled “We rely on third parties to provide goods and services in connection with the manufacture and distribution of our products” and “We are subject to risks related to the manufacture of our products.”

Marketed Products

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For more information about our Wilmington, Ohio manufacturing facility, see “Item 2—Properties” in this Annual Report.

We have entered into subcontracting arrangements for the manufacture of several products in the Athlone Facility that are marketed by third parties, including VUMERITY.

This facility has been inspected by regulatory authorities of numerous jurisdictions for compliance with required cGMP standards for continued commercial manufacturing.

We purchase LUMRYZ API and outsource the manufacturing of LUMRYZ drug product to several contract manufacturers in the U.S.

and outside of the U.S.

The manufacture and distribution of LUMRYZ is highly restricted, as its API (sodium oxybate) and finished product are Schedule I and Schedule III controlled substances in the U.S., respectively, subject to regulation by the U.S.

Drug Enforcement Administration of the U.S.

Department of Justice (the “DEA”) under the Controlled Substances Act (the “CSA”).

Quotas from the DEA are required in order to manufacture both sodium oxybate and LUMRYZ in the U.S.

and the contract manufacturer facilities are, like ours, subject to inspection and audit by the FDA and the DEA for cGMP compliance.

We were previously party, through various end dates in 2025, to subcontracting arrangements for the manufacture of several products in the Athlone Facility that are marketed by third parties, including VUMERITY.

All of our subcontract manufacturing arrangements at the Athlone Facility concluded by the end of 2025.

Clinical Products

We manufacture clinical supplies of injectable extended-release products and solid dosage form products at our Wilmington, Ohio facility.

We have also contracted with third-party manufacturers to formulate certain products for clinical use.

We have also contracted with third-party manufacturers to formulate and manufacture certain products for clinical use.

We require that our contract manufacturers adhere to cGMP in the manufacture of our products or components of our products for clinical use.

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We hold various permits, registrations, approvals and/or licenses in respect of our manufacturing and related activities.

The primary licenses held in this regard are FDA Registrations of Drug Establishment, and licenses from the Drug Enforcement Administration of the U.S.

Department of Justice (the “DEA”).

The primary licenses that we hold in this regard are FDA Registrations of Drug Establishment, and licenses from the DEA.

We also hold various authorizations, licenses and certificates from the Health Products Regulatory Authority in Ireland, including an Investigational Medicinal Products Manufacturers Authorization (No.

IMP074/00002) and a Manufacturers Authorization (No.

M13297/00001) in respect of our offices located in Dublin, Ireland, and a Manufacturers Authorization (No.

M13297/00002), in respect of the Athlone Facility, pending completion of updates to applicable product filings.

M13297/00001) in respect of our offices located in Dublin, Ireland.

We also hold current GMP certificates associated with each of these authorizations.

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We generally update this information annually with the relevant regulator.

In other cases where we have developed proprietary products, such as VIVITROL, ARISTADA, ARISTADA INITIO and LYBALVI, we hold the marketing authorization and related regulatory documentation ourselves.

For our proprietary products, such as ARISTADA, ARISTADA INITIO, LUMRYZ, LYBALVI and VIVITROL, we hold the marketing authorization and related regulatory documentation ourselves.

Marketing, Sales and Distribution

We are responsible for the marketing of VIVITROL, ARISTADA, ARISTADA INITIO, and LYBALVI in the U.S.

We are responsible for the marketing of ARISTADA, ARISTADA INITIO, LYBALVI, LUMRYZ and VIVITROL in the U.S.

We focus our sales and marketing efforts on physicians in private practice and in public treatment systems.

We believe that we use customary pharmaceutical company practices to market our products, including through advertisements, professional symposia, selling initiatives and other methods, and to educate individual physicians, nurses, social workers, counselors and other stakeholders involved in the treatment of opioid dependence, alcohol dependence, schizophrenia and bipolar I disorder.

We provide, and contract with third-party vendors to provide, customer services and other related programs for our products, such as product-specific websites, insurance research services and order, delivery and fulfillment services.

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Product sales of LYBALVI during the year ended December 31, 2025 to McKesson Corporation, Cardinal Health and Cencora represented approximately 32%, 29% and 35%, respectively, of total LYBALVI gross sales.

ICS, a division of Cencora, provides warehousing, shipping and administrative services for VIVITROL, ARISTADA, ARISTADA INITIO and LYBALVI.

Our sales force for LUMRYZ in the U.S.

became a part of the Company in February 2026 when we completed the Avadel Acquisition.

As of the completion of the Avadel Acquisition, this sales force consisted of approximately 60 individuals.

LUMRYZ is distributed through a closed network of three commercial specialty pharmacies:

CVS, Accredo, and Optum, and one non-commercial specialty pharmacy:

ICS, a division of Cencora, provides warehousing, shipping and administrative services for ARISTADA, ARISTADA INITIO, LYBALVI and VIVITROL.

Eversana provides warehousing, shipping and administrative services for LUMRYZ.

Under our license agreements with Janssen, Biogen and other licensees and sublicensees, the licensees and sublicensees are typically responsible for the commercialization of any products developed under their respective agreements if and when regulatory approval is obtained.

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product acceptance by, and preferences of, physicians, other healthcare providers and patients;

our ability to comply with applicable laws, regulations and regulatory requirements with respect to the manufacture and/or commercialization of our products, including any changes or increases to regulatory restrictions;

our ability to comply with applicable laws, regulations and regulatory requirements with respect to the manufacture and/or commercialization of our products, including any imposed REMS program or any other changes or increases to regulatory restrictions;

protection of our proprietary rights relating to our products;

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our ability to complete clinical development and obtain regulatory approvals for our products, and the timing and scope of any such regulatory approvals;

our ability to successfully manufacture and provide a reliable supply of commercial quantities of a product to the market;

our, or our contract manufacturers’, ability to successfully manufacture and provide a reliable supply of commercial quantities of a product to the market;

and our ability to recruit, retain and develop skilled employees.

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ABILIFY ASIMTUFII (aripiprazole), a once-every-two-months injectable formulation of ABILIFY (aripiprazole) developed by Otsuka Pharm.

PERSERIS (risperidone for extended release injectable suspension), a once-monthly formulation of risperidone marketed by Indivior plc;

RYKINDO (risperidone), a once-every-two-weeks injectable formulation of risperidone developed by Luye Pharma Group;

UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, developed and marketed by MedinCell S.A.

and generic versions of branded injectable products.

In the treatment of schizophrenia, LYBALVI competes with other oral antipsychotic products, including CAPLYTA (lumateperone) developed and marketed by Intra-Cellular Therapies, Inc.;

and generic versions of branded injectable products, such as risperidone for extended-release injectable suspension marketed by Lupin Limited and by Amneal Pharmaceuticals, Inc, both of which reference RISPERDAL CONSTA.

In the treatment of schizophrenia, LYBALVI competes with other oral antipsychotic products, including CAPLYTA (lumateperone) marketed by Johnson & Johnson or its affiliated companies.;

REXULTI (brexpiprazole), which is co-marketed by Otsuka Pharm Co.

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and BRIUMVI (ublituximab-xiiy) from TG Therapeutics, Inc.

In the treatment of narcolepsy, LUMRYZ competes with twice-nightly oxybate formulations, such as XYWAV (sodium oxybate) and XYREM (sodium oxybate), as well as a number of daytime wake promoting agents, including VYVANSE (lisdexamfetamine), dextroamphetamine, methylphenidate, amphetamine, modafinil, and armodafinil, which are widely prescribed, as well as SUNOSI (solriamfetol) from Axsome Therapeutics, Inc.

and WAKIX (pitolisant) from Harmony Biosciences Holdings, Inc.

LUMRYZ also competes with generic versions of XYREM.

We and other pharmaceutical companies are developing products, including orexin 2 receptor agonists such as alixorexton and other formulations of sodium oxybate, that have shown or may show potential in treating narcolepsy that, if approved by the FDA, would compete with LUMRYZ.

With respect to our NANOCRYSTAL technology, we are aware that other technology approaches similarly address poorly water-soluble drugs.

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ARISTADA INITIO

We have a number of patents and pending patent applications covering our microsphere technology throughout the world, which, to some extent, cover VIVITROL.

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patent covering VIVITROL, which expires in the U.S.

For a discussion of legal proceedings related to VIVITROL, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report.

Pursuant to the terms of a confidential settlement and license agreement entered into in August 2023 with Teva, we granted Teva a non-exclusive, royalty-free, non-transferable, non-sublicensable limited license under the remaining patent covering VIVITROL to market and sell a generic version of VIVITROL in the U.S.

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beginning on the earlier of the First Entry Date, sometime in 2028 or earlier under certain circumstances.

In September 2025, we entered into an authorized generic product supply agreement (the “AG Agreement”) with Amneal, pursuant to which we granted Amneal certain rights to distribute and sell in the U.S.

an authorized generic version of VIVITROL (the “Amneal AG Product”) for a one-year term beginning on the date of a Third Party ANDA Product Launch (as defined in the AG Agreement);

provided, however , that if a Third Party ANDA Product Launch does not occur within ninety (90) days after the First Entry Date (or an earlier launch date under certain circumstances) (a “Third Party ANDA Product Launch Failure”), Amneal shall no longer have the right to distribute and sell the Amneal AG Product;

provided further , that, in such event, upon written request from Amneal, we agreed to consider, for a period of thirty (30) days from the date of the Third Party ANDA Product Launch Failure, whether to allow Amneal a second opportunity to launch the Amneal AG Product.

In the event that Amneal launches its own generic version of VIVITROL (other than the Amneal AG Product) pursuant to the July 2019 license grant described above, we would have a right to terminate the AG Agreement.

INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI

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and expire in 2041.

For a discussion of legal proceedings related to patents covering INVEGA TRINZA, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report.

patents and patent applications, and a number of corresponding non-U.S.

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8,669,281, 9,090,558 and 10,080,733, each expiring in 2033, cover compositions of, or methods of treatment for, VUMERITY.

For a discussion of legal proceedings related to patents covering VUMERITY, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report.

We own or have a license to U.S.

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Expiration Date

For a discussion of legal proceedings related to patents covering LYBALVI, see Note 19, Commitments and Contingent Liabilities in the “Notes to Consolidated Financial Statements” in this Annual Report.

We own numerous U.S.

patents and patent applications, and a number of corresponding non-U.S.

counterparts, that cover LUMRYZ with expiration dates spanning from mid-2037 to early-2042.

LUMRYZ was also granted seven years of FDA ODE for its approved adult and pediatric narcolepsy patient populations through May 2030 and October 2031, respectively.

Our principal U.S.

patents for LUMRYZ and their expiration dates are as follows:

Product Covered

Expiration Date

Pursuant to the Avadel Settlement Agreement, we have a worldwide, non-exclusive, royalty-bearing license under any past, present, or future Jazz patents that could be asserted against LUMRYZ, to market and sell LUMRYZ for narcolepsy and, beginning March 1, 2028, for any non-narcolepsy indications, including idiopathic hypersomnia.

In exchange, from October 1, 2025, Jazz will receive a royalty of 3.85% (subject to potential reduction as set forth in the agreement) on net sales of LUMRYZ sold for narcolepsy and, beginning no earlier than March 1, 2028, an additional royalty of 10% (subject to potential reduction as set forth in the agreement) on net sales of LUMRYZ sold for any future FDA-approved indications (other than narcolepsy), in each case through February 18, 2036.

Avadel also agreed not to market, sell or provide services for LUMRYZ for any non-narcolepsy indications prior to March 1, 2028, and that any unpermitted sales during such timeframe would be subject to a royalty of 80% of such net sales for any quarter in which such net sales exceed $2.25 million.

Among other things, Jazz also agreed not to challenge the approvability of LUMRYZ for any present or future indications and Avadel granted Jazz a covenant not to sue under the patents covering LUMRYZ in connection with Jazz’s marketing and sale of XYWAV and XYREM for any present and future indications.

patent protection that extends to 2041, several U.S.

patent applications, and a number of corresponding non-U.S.

counterparts, that cover ALKS 2680.

counterparts that cover alixorexton.

Protection of Proprietary Rights and Competitive Position

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For more information, see “Item 1A—Risk Factors” in this Annual Report.

Our trademarks, including VIVITROL, ARISTADA, ARISTADA INITIO and LYBALVI, are important to us and are generally covered by trademark applications or registrations with the U.S.

Our trademarks, including ARISTADA, ARISTADA INITIO, LUMRYZ, LYBALVI and VIVITROL, are important to us and are generally covered by trademark applications or registrations with the U.S.

Patent and Trademark Office (the “USPTO”) and the patent or trademark offices of other countries.

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Even if a product is approved, the approval may be subject to limitations based on the FDA’s interpretation of the data.

For example, the FDA may require, as a condition of approval, restricted distribution and use, enhanced labeling, special packaging or

labeling, expedited reporting of certain adverse events, pre-approval of promotional materials or restrictions on direct-to-consumer advertising, any of which could negatively impact the commercial success of a drug.

For example, the FDA may require, as a condition of approval, restricted distribution and use, enhanced labeling, special packaging or labeling, expedited reporting of certain adverse events, pre-approval of promotional materials or restrictions on direct-to-consumer advertising, any of which could negatively impact the commercial success of a drug.

The FDA may also require a sponsor to conduct additional post-marketing studies as a condition of approval to provide data on safety and effectiveness.

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The DEA regulates pharmaceutical products that are controlled substances.

Controlled substances are those drugs that appear on one of the five schedules promulgated and administered by the DEA under the Controlled Substances Act (the “CSA”).

The CSA governs, among other things, the inventory, distribution, recordkeeping, handling, security and disposal of controlled substances.

For example, pharmaceutical products that act on the CNS are often evaluated for abuse potential;

if a product is then classified as a controlled substance, it must undergo scheduling by the DEA, which is a separate process that may delay the commercial launch of such product even after FDA approval of the NDA for such product.

Controlled substances are those drugs that appear on one of the five schedules promulgated and administered by the DEA under the CSA.

Schedule I substances by definition have a high potential for abuse, have no currently “accepted medical use” in the U.S., lack accepted safety for use under medical supervision, and may not be prescribed, marketed or sold in the U.S.

Pharmaceutical products approved for use in the U.S.

may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk of abuse.

If a product is classified as a controlled substance, it must undergo the process of scheduling by the DEA into one of these five schedules, which is a process that is separate from FDA approval of the NDA for such product and may delay the commercial launch of such product even after FDA approval.

The CSA also governs, among other things, the inventory, distribution, recordkeeping, handling, security and disposal of controlled substances.

Schedule I and II drugs are subject to the strictest controls, including manufacturing and procurement quotas, heightened security requirements and additional criteria for importation.

In addition, dispensing of Schedule II drugs is subject to additional requirements.

Further, companies with a scheduled pharmaceutical product are subject to periodic and ongoing inspections by the DEA and similar state drug enforcement authorities to assess ongoing compliance with the DEA’s regulations.

Any person or firm that manufactures, distributes, dispenses, imports, or exports any controlled substance, or proposes to do so, must register with the DEA for a specific business activity related to controlled substances, including manufacturing or distributing, and may engage in only the activity or activities for which it is registered.

The DEA conducts periodic inspections of registered establishments for compliance with its rules and regulations.

Any failure to comply with these regulations could lead to a variety of sanctions, including the revocation, or a denial of renewal, of any DEA registration and injunctions, or civil or criminal penalties.

In addition to these U.S.

federal statutory obligations, there may be additional U.S.

state and local laws and regulations relevant to the handling of controlled substances.

Outside the United States

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A marketing application approved by the EC is valid in all EU member states.

In addition to the centralized procedure, Europe also has:

In addition to this centralized procedure, Europe also has:

(i) a nationalized procedure, which requires a separate application to, and approval determination by, each country;

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The FDA, the EMA, the competent authorities of the EU member states and other regulatory agencies regulate and inspect equipment, facilities and processes used in the manufacturing of pharmaceutical products prior to approving a product.

Once approval from a regulatory agency is obtained, if a company makes a material change in manufacturing equipment, location or process,

additional regulatory review and approval may be required.

Once approval from a regulatory agency is obtained, if a company makes a material change in manufacturing equipment, location or process, additional regulatory review and approval may be required.

Companies also must adhere to cGMP and product-specific regulations enforced by the FDA and other regulatory agencies both in the manufacture of clinical product and following product approval.

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The Hatch-Waxman Act provides five years of new chemical entity (“NCE”) marketing exclusivity to the first applicant to gain approval of an NDA for a product that contains an active ingredient, known as the active drug moiety, not found in any other approved product.

The FDA is prohibited from accepting any abbreviated new drug application (“ANDA”) for a generic drug or 505(b)(2) application referencing the NCE for five years from the date of approval of the NCE, or four years in the case of an ANDA or 505(b)(2) application containing a patent challenge, and in both cases may not approve such generic drug or 505(b)(2) application until expiration of NCE marketing exclusivity.

The FDA is prohibited from accepting any

abbreviated new drug application (“ANDA”) for a generic drug or 505(b)(2) application referencing the NCE for five years from the date of approval of the NCE, or four years in the case of an ANDA or 505(b)(2) application containing a patent challenge, and in both cases may not approve such generic drug or 505(b)(2) application until expiration of NCE marketing exclusivity.

A 505(b)(2) application is an NDA in which the applicant relies, in part, on data and the FDA’s findings of safety and efficacy from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

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Orphan drug designation does not shorten the duration of the regulatory review process or lower the approval standards, but can provide important benefits, including consultation with the FDA.

If a product is approved for its orphan designated use, it may be entitled to Orphan Drug Exclusivity (“ODE”), which blocks the FDA from approving for seven years any other application for a product that is the same drug for the same indication.

If a product is approved for its orphan designated use, it may be entitled to orphan drug exclusivity (“ODE”), which blocks the FDA from approving for seven years any other application to market a product that is the same drug for the same indication, except in certain limited circumstances.

ODE does not prevent approval of another sponsor’s application for different indications or uses of the same drug, or for different drugs for the same indication.

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If we were subject to allegations concerning, or were convicted of violating, these laws, our business could be harmed.

See “Item 1A—Risk Factors” in this Annual Report and specifically those sections entitled “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,” “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” and “The clinical study or commercial use of our products may cause unintended side effects or adverse reactions, or incidents of misuse may occur, which could adversely affect our products, business and share price.”

healthcare industry, we could be subject to investigations, litigation, costs, penalties and business losses,” “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” and “The clinical study or commercial use of our products may cause unintended side effects or adverse reactions, or incidents of misuse may occur, which could adversely affect our products, business and share price.”

Laws and regulations have been enacted by the U.S.

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If a manufacturer is found to have made a misrepresentation in the reporting of ASP, the statute provides for civil monetary penalties for each misrepresentation and for each day in which the misrepresentation was applied.

In October 2025, CMS finalized the CY 2026 Medicare Physician Fee Schedule rule, which, among other provisions, increases documentation requirements for bona fide service fees, establishes a methodology for allocating discounts in bundled arrangements, and requires that sales of Part B units at the Maximum Fair Price be included in ASP calculations.

These changes impose additional, complex reporting and documentation obligations, may lower ASP of our products and reimbursement under Medicare Part B and may increase our engagement with CMS in respect of price concessions.

Medicare Part D provides coverage to enrolled Medicare patients for self-administered drugs (i.e., drugs that do not need to be injected or otherwise administered by a physician) and certain physician-administered drugs reimbursed under a pharmacy benefit.

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one for drugs generally dispensed through retail community pharmacies (“RCP”) and one for so-called “5i drugs” (inhaled, infused, instilled, implanted or injectable drugs) “not generally dispensed” through RCPs.

The regulation further made clear that 5i drugs would qualify as “not generally dispensed” and, therefore, able to use the alternative AMP calculation, if not more than thirty percent (30%) of their sales were to RCPs or to wholesalers for RCPs.

The regulation further made clear that 5i drugs would qualify as “not generally dispensed” and, therefore, able to use the alternative AMP calculation, if not

more than thirty percent (30%) of their sales were to RCPs or to wholesalers for RCPs.

The primary difference between the two AMP calculations is the requirement to include in AMP, for those qualifying 5i drugs not generally dispensed through RCPs, certain payments, rebates and discounts related to sales to non-RCPs;

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In August 2022, the Inflation Reduction Act was signed into law.

The Inflation Reduction Act includes several provisions that will impact our business to varying degrees, including those that impose new manufacturer financial liability on all drugs in Medicare Part D beginning in 2025, allow the U.S.

The Inflation Reduction Act includes several provisions that will impact our business to varying degrees, including those that imposed new manufacturer financial liability on all drugs in Medicare Part D beginning in 2025, allow the U.S.

government to negotiate prices for some drugs covered under Medicare Part D beginning in 2026 and Medicare Part B beginning in 2028, and require companies to pay rebates to Medicare for drug prices that increase faster than inflation.

Additionally, the One Big Beautiful Bill Act (the “OBBBA”), which was enacted in July 2025, imposes significant reductions in the funding of the Medicaid program, which are expected to decrease the number of individuals enrolled in Medicaid and reduce the services covered by Medicaid.

The OBBBA also modified the Inflation Reduction Act’s exclusion protecting orphan drugs designated for a single rare disease indication from required Medicare pricing negotiations by expanding it to apply to drugs designated for multiple rare diseases and by prohibiting Medicare price negotiations until seven years after an orphan drug is approved for a non-orphan indication.

Throughout 2025, the U.S.

federal government pursued multiple initiatives aimed at tying U.S.

drug prices to those paid in certain other developed countries through a “Most‑Favored‑Nation” (“MFN”) pricing framework.

These actions included a 2025 Executive Order entitled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” in which CMS was instructed to create plans to impose MFN pricing on drug manufacturers.

Following the Executive Order, CMS advanced three MFN-based payment models through the Center for Medicare and Medicaid Innovation (“CMMI”):

the “Global Benchmark for Efficient Drug Pricing” (“GLOBE”), which would implement a new, mandatory drug rebate program tied to MFN pricing for select drugs in Medicare Part B and is proposed to go into effect on October 1, 2026;

“Guarding U.S.

Medicare Against Rising Drug Costs” (“GUARD”), which would implement a similar mandatory drug rebate program for select drugs in Medicare Part D and is proposed to go into effect on January 1, 2027;

and “GENErating cost Reductions fOr U.S.

Medicaid” (“GENEROUS”), launched in January 2026, under which manufacturers who choose to participate in the model would pay MFN-based supplemental rebates under the Medicaid program in exchange for standardized coverage criteria in participating states.

These models are likely to face legal and operational challenges, and the implementation of these models remains uncertain.

In parallel to these CMS initiatives, several major pharmaceutical manufacturers have entered into voluntary agreements with the U.S.

federal government to provide discounted prices aligned to MFN prices on certain of the manufacturers’ drugs to the Medicaid program and direct to patients.

In addition, emphasis on managed care in the U.S.

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As a global biopharmaceutical company focused on developing innovative medicines in the field of neuroscience, we have built, and continue to devote significant resources to further develop and enhance, a comprehensive cross-functional infrastructure designed to support product development from discovery through commercialization and lifecycle management.

We seek to attract, hire, develop, recognize and retain qualified and highly skilled employees with experience in areas such as R&D, including early discovery, medicinal chemistry, translational medicine, formulation development, and clinical trials operations capabilities;

We seek to attract, hire, develop, retain and motivate qualified and highly-skilled employees with experience in areas such as R&D, including early discovery, medicinal chemistry, translational medicine, formulation development, and clinical trials operations capabilities;

IP prosecution, enforcement and defense;

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sales and marketing;

and market access, among other areas.

Competition for such personnel in our industry and the geographic regions in which we operate is intense, with numerous companies also developing, launching or marketing products, including products against which our products directly compete.

We are committed to supporting our employees’ well-being in a transparent, diverse, inclusive, and collaborative environment and to providing them with access to training, support and resources intended to help them succeed professionally, while balancing their professional and personal lives.

and market access, among others.

Competition for such personnel in our industry and the geographic regions in which we operate is intense, with numerous companies also developing, manufacturing or marketing products, including products against which our products directly compete.

We are committed to supporting our employees’ well-being in a transparent, inclusive and collaborative environment and to providing our employees with access to training, support and resources intended to help them succeed professionally while appropriately balancing their professional and personal lives.

As of February 20, 2026, we had approximately 2,050 full time employees, of which approximately 1,950 were based in the U.S.

and 100 were based in Ireland.

and approximately 100 were based in Ireland.

Our 2025 global voluntary attrition rate of 7.0% was below industry benchmarks.

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In support of our business, we seek to cultivate a work environment that reflects collaboration, respect for each voice, and unwavering commitment, and strengthens the sense of belonging among our employees.

Reflecting the needs of our employees, we have established a global steering committee, comprised of representatives from all of our locations (including field-based employees), focused on creating connections, fostering conversations, and helping to support alignment of our efforts across the range of perspectives within our organization.

We have collaborated with our employees to create five employee resource groups, or ERGs:

Reflecting the needs of our employees, we have established a global steering committee, comprised of representatives from all of our locations (including field-based employees), focused on employee engagement, creating connections, fostering conversations, promoting a culture of understanding and inclusion, and helping to support alignment of our efforts across the range of perspectives within our organization.

In recent years, we have collaborated with our employees to create five employee resource groups, or ERGs:

Limitless, a network to support people impacted by disability or illness;

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and Women Inspired Network (WIN), a women’s network.

These ERGs, which are open to all employees, share a common purpose of supporting and enhancing the inclusiveness of our company culture and providing opportunities for professional development, networking, learning and building deeper connections within Alkermes.

These ERGs,which are employee-led, voluntary and open to all employees, share a common purpose of building community, providing opportunities for professional development and networking, and having a positive impact on our culture and our business.

We encourage active employee engagement to help ensure that employees feel part of our mission and that they have a voice in the Alkermes community.

Since 2017, we have conducted periodic employee engagement surveys to understand employee sentiment regarding, and satisfaction with, their work and experience at Alkermes, and have used, and plan to continue to use, the data collected to help inform and evolve our human capital management strategy and initiatives.

We conduct periodic employee engagement surveys to understand employee sentiment regarding, and satisfaction with, their work and experience at Alkermes, and have used, and plan to continue to use, the data collected to help inform and evolve our human capital management strategy and initiatives.

We survey employees at least annually, which allows our employees to share their insights on a regular basis and provides us with opportunities to regularly assess and address employee feedback.

As many of our office-based employees have adapted to a hybrid work model, we have continued to implement our expanded employee communications strategies to keep all employees connected and informed.

As many of our office-based employees have adapted to a hybrid work model, we have continued to utilize expanded employee communications strategies to keep our employees connected and informed.

We are committed to the professional growth and development of our employees.

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We encourage and support our employees in their adoption of Individual Development Plans designed to identify professional development and growth opportunities to help support their career aspirations.

We frequently offer Company-hosted trainings that cover topics including performance management, problem-solving, leadership development, diversity, communication and mentorship, and as appropriate, more specialized skills-based programs.

We encourage our employees to seek out professional learning opportunities both within Alkermes and externally, through part-time education and tuition reimbursement programs, and frequent offerings of voluntary Company-hosted trainings that cover topics including performance management, problem-solving, leadership development, diversity

education and awareness, communication and mentorship, and as appropriate, more specialized skills-based programs.

We also provide all employees access to our LinkedIn Learning platform, which provides on-demand learning opportunities.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business