What changed in this filing

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Item 1. Business

2025-02-12 compared with 2024-02-21 · 144 added, 149 removed, 595 unchanged (33% 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.

Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts;

a research and manufacturing facility in Athlone, Ireland;

and a manufacturing facility in Wilmington, Ohio.

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.

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

Marketed Products

The key marketed products discussed below have generated, or are expected to generate, significant revenues for us.

See “Patents and Proprietary Rights” in “Item 1—Business” in this Annual Report for information with respect to the IP protection for these marketed products.

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 these marketed products.

The following provides summary information regarding our proprietary products that we commercialize:

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Opioid dependence

The following provides summary information regarding our key licensed product, and certain key third-party products using our proprietary technologies under license, that are commercialized by our licensees:

The following provides summary information regarding certain key third-party products using our proprietary technologies under license and our key licensed product, that are commercialized by our licensees:

Key Third-Party Products Using Our Proprietary Technologies

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We have developed and now commercialize products designed to help address the unmet needs of people living with opioid dependence, alcohol dependence, schizophrenia and bipolar I disorder.

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

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 proprietary products.

ARISTADA and ARISTADA INITIO

ARISTADA (aripiprazole lauroxil) is an extended-release intramuscular injectable suspension approved in the U.S.

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

In January 2024, U.S.

11,883,394 relating to ARISTADA was granted.

The patent has claims to the crystallization process of aripiprazole lauroxil and expires in 2035.

ARISTADA INITIO

ARISTADA INITIO (aripiprazole lauroxil) leverages our proprietary LinkeRx and NanoCrystal technologies and provides an extended-release formulation of aripiprazole lauroxil in a smaller particle size compared to ARISTADA, thereby enabling faster dissolution and more rapid achievement of relevant levels of aripiprazole in the body.

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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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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.

What is schizophrenia?

See the disease state description under “ARISTADA” in “Item 1—Business” in this Annual Report.

See the disease state description in the section entitled “ ARISTADA and ARISTADA INITIO ” in “Item 1—Business” in this Annual Report.

What is bipolar I disorder?

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had an alcohol use disorder* in the prior year.

Adherence to medication is particularly challenging with these patient populations.

Adherence to medication is particularly challenging with these disease states.

In 2013, with the publication of the Diagnostic Statistical Manual (“DSM”) 5, the DSM-IV diagnoses of substance use disorders as either dependence or abuse (i.e., opioid dependence or alcohol dependence), which reflects the approved indications of VIVITROL, were subsumed under a new diagnostic category of “substance use disorders” (i.e., opioid use disorder or alcohol use disorder) with three categories of disorder severity—mild, moderate or severe.

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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 “Proprietary Technology Platforms” and “Patents and Proprietary Rights” sections 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 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.

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 SUSTENNA and 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 “We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”

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?

See the disease state description under “ARISTADA” in “Item 1—Business” in this Annual Report.

See the disease state description in the section entitled “ ARISTADA and ARISTADA INITIO ” in “Item 1—Business” in this Annual Report.

What is schizoaffective disorder?

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What is schizophrenia?

See the disease state description under “ARISTADA” in “Item 1—Business” in this Annual Report.

See the disease state description in the section entitled “ ARISTADA and ARISTADA INITIO ” in “Item 1—Business” in this Annual Report.

Licensed Product

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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 “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 “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 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.”

What is multiple sclerosis?

Multiple sclerosis, or MS, is an unpredictable, often disabling disease of the central nervous system (“CNS”), which interrupts the flow of information within the brain, and between the brain and body.

Multiple sclerosis (“MS”) is an unpredictable, often disabling disease of the central nervous system (“CNS”), which interrupts the flow of information within the brain, and between the brain and body.

MS symptoms can vary over time and from person to person.

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Important factors that could adversely affect our drug development efforts are discussed in “Item 1A—Risk Factors” in this Annual Report.

See the “Patents and Proprietary Rights” section 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 (“OX2R”) agonist in development for the treatment of narcolepsy.

Orexin neuropeptides are important regulators of the sleep/wake cycle through OX2R activation, and loss of orexinergic neurons in the brain is associated with excessive daytime sleepiness and cataplexy in narcolepsy.

ALKS 2680 was designed to address the underlying pathology of narcolepsy with the goals of improving duration of wakefulness and providing cataplexy control.

Once-daily oral administration of ALKS 2680 is currently being evaluated in a phase 1 study in healthy volunteers and people living with narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia.

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.

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.

Collaborative Arrangements

We have entered into several collaborative arrangements to develop and commercialize products and, in connection with such arrangements, to access technological, financial, marketing, manufacturing and other resources, including the arrangements described below.

We have entered into several collaborative arrangements to develop and commercialize products and, in connection with such arrangements, to access or provide access to, technological, financial, marketing, manufacturing and other resources, including the arrangements described below.

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

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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.

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and 7.5% on calendar year net sales exceeding $500 million.

The know-how royalty rate resets to 3.5% at the beginning of each calendar year and is payable until 15 years

from the first commercial sale of a product in each individual country, subject to expiry of the agreement.

The know-how royalty rate resets to 3.5% at the beginning of each calendar year and is payable until 15 years from the first commercial sale of a product in each individual country, subject to expiry of the agreement.

These royalty payments may be reduced in any country based on patent litigation or on competing products achieving certain minimum sales thresholds.

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Either party may terminate the license agreements by written notice following a breach which continues for 90 days after the delivery of written notice thereof or upon the other party’s insolvency.

The licenses granted to Janssen expire on a country-by-country basis upon the later of (i) the expiration of the last patent claiming the product in such country or (ii) 15 years after the date of the first commercial sale of the product in such country, provided that in no event will the license granted to Janssen expire later than the twentieth anniversary of the first commercial sale of the product in each such country, with the exception of Canada, France, Germany, Italy, Japan, Spain and the United Kingdom, in each case, where the fifteen-year minimum shall pertain regardless.

After expiration, Janssen retains a non-exclusive, royalty-free license to manufacture, use and sell RISPERDAL CONSTA.

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Under a license and collaboration agreement with Biogen, we granted Biogen a worldwide, exclusive, sublicensable license to develop, manufacture and commercialize VUMERITY and other products covered by patents licensed to Biogen under that agreement.

Under this license and collaboration agreement, we received an upfront cash payment and milestone payments related to the achievement of certain milestones, including FDA approval of the NDA for VUMERITY and amendment of the license and collaboration agreement.

Under this license and collaboration agreement, we received an upfront cash payment and milestone payments related to the achievement of certain milestones.

We are also eligible to receive additional payments upon achievement of certain milestones, including milestones relating to the first two products other than VUMERITY covered by patents licensed to Biogen under the license and collaboration agreement.

In addition, we receive a 15% royalty on worldwide net sales of VUMERITY, subject to increases for VUMERITY manufactured and/or packaged by Biogen or its designees, and, under certain circumstances, minimum annual payments for the first five years following FDA approval of VUMERITY.

In addition, we receive a 15% royalty, subject to increases for VUMERITY manufactured and/or packaged by Biogen or its designees, on worldwide net sales of VUMERITY.

We are also entitled to receive royalties on net sales of products other than VUMERITY covered by patents licensed to Biogen under the license and collaboration agreement, at tiered royalty rates calculated as percentages of net sales ranging from high-single digits to sub-teen double digits.

All royalties are payable on a product-by-product and country-by-country basis until the later of (i) the last-to-expire patent right covering the applicable product in the applicable country and (ii) a specified period of time from the first commercial sale of the applicable product in the applicable country.

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

Except in limited circumstances, we were responsible for the development of VUMERITY until it was approved by the FDA.

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.

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 and subject to good faith agreement by the parties on the terms of such manufacturing arrangements.

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 elected to conduct a technology transfer and, subject to an agreed manufacturing transition period, assume responsibility for the manufacture (itself or through a designee) of clinical supplies of VUMERITY and up to 100% of commercial supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to us on net sales of that portion of product that is manufactured by Biogen or its designee.

In December 2023, we announced entry into a definitive agreement to sell our research and development and manufacturing facility in Athlone, Ireland (the “Athlone Facility”) where VUMERITY is manufactured, which transaction is expected to close in mid-2024.

In connection with the sale of the Athlone Facility, we have agreed to enter into a subcontracting arrangement with the purchaser of the Athlone Facility for the manufacture of VUMERITY through the manufacturing transition period.

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.

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

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Manufacturing and Product Supply

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

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.

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

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.

However, we cannot be certain that we will continue to be able to obtain long-term supplies of our manufacturing materials or long-term provision of related services.

Our supply chain includes an external network of third-party service providers involved in the manufacture of our products who are subject to inspection by the FDA or comparable agencies in other jurisdictions.

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 sell our products or advance our development efforts, as the case may be.

In December 2023, we announced that we entered into a definitive agreement to sell the Athlone Facility to Novo Nordisk (“Novo”) and that we plan to enter into subcontracting arrangements to continue certain development and manufacturing activities currently performed at the Athlone Facility for a period of time after the closing of the transaction, which may continue through the end of 2025.

Such transaction is subject to various uncertainties and risks, including, without limitation, satisfaction of the conditions to closing of the transaction on the anticipated timeline, potential negative impacts on our relationships with current suppliers or licensees, diversion of management and employee attention from daily business operations, and risks inherent in the transition to subcontracting arrangements.

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 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.”

Our supply chain includes an external network of third-party service providers involved in the manufacture of our products whose manufacturing facilities and processes are, like ours, subject to inspection by the FDA or comparable agencies in other jurisdictions.

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.”

Marketed Products

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Our Wilmington, Ohio facility has been inspected by U.S., European (including the UK Medicines and Healthcare products Regulatory Agency), Chinese, Japanese, Brazilian, Turkish, Russian and Saudi Arabian regulatory authorities for compliance with required cGMP standards for continued commercial manufacturing.

We manufacture several products in the Athlone Facility that are marketed by third parties, including FAMPYRA and VUMERITY.

This facility has been inspected by U.S., Irish, Brazilian, Turkish, Libyan, Saudi Arabian, Korean, Belarusian, Russian and Chinese regulatory authorities for compliance with required cGMP standards for continued commercial manufacturing.

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

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.

Clinical Products

We have established, and are operating, facilities with the capability to manufacture clinical supplies of injectable extended-release products and solid dosage form products at our Wilmington, Ohio facility and solid dosage form products at the Athlone Facility.

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.

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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 (“DEA”).

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

IMP074/00002) in respect of our offices located in Dublin, Ireland;

and a Manufacturers Authorization (No.

M1067), an Investigational Medicinal Products Manufacturers Authorization (No.

IMP074/00001) and Certificates of Good Manufacturing Practice Compliance of a Manufacturer (Ref.

2014/7828/IMP074 and 2014/7828/M1067) in respect of the Athlone Facility.

Department of Justice (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.

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

Due to certain U.S.

state law requirements, we also hold state licenses to cover distribution activities conducted in certain states where required.

We do not generally act as the marketing authorization holder for products incorporating our drug delivery technologies that have been developed on behalf of a licensee of such technologies.

Additional Manufacturer Authorizations that we previously held in respect of the Athlone Facility were transferred to Novo with the sale of the facility and related business in May 2024.

We do not generally act as the marketing authorization holder for products incorporating our technologies that have been developed on behalf of a licensee of such technologies.

In such cases, our licensee usually holds the relevant marketing authorization from the FDA or other relevant regulatory authority, and we support this authorization as needed, including by furnishing a copy of the product’s Drug Master File, or chemistry, manufacturing and controls data, to the relevant regulator.

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Our sales force for VIVITROL in the U.S.

consists of approximately 115 individuals.

consisted of approximately 105 individuals as of December 31, 2024.

VIVITROL is primarily sold to pharmaceutical wholesalers, pharmacies, specialty distributors and treatment providers.

Product sales of VIVITROL during the year ended December 31, 2023 to Cardinal Health, McKesson Corporation and AmerisourceBergen Corporation (“AmerisourceBergen”) represented approximately 27%, 23% and 16%, respectively, of total VIVITROL gross sales.

Product sales of VIVITROL during the year ended December 31, 2024 to McKesson Corporation, Cardinal Health and Cencora, Inc.

(formerly known as Amerisource Bergen, “Cencora”) represented approximately 34%, 21% and 16%, respectively, of total VIVITROL gross sales.

Our sales force for ARISTADA, ARISTADA INITIO and LYBALVI in the U.S.

consists of approximately 360 individuals.

consisted of approximately 355 individuals as of December 31, 2024.

ARISTADA, ARISTADA INITIO and LYBALVI are primarily sold to pharmaceutical wholesalers.

Product sales of ARISTADA and ARISTADA INITIO during the year ended December 31, 2023 to Cardinal Health, AmerisourceBergen and McKesson Corporation represented approximately 46%, 24% and 23%, respectively, of total ARISTADA and ARISTADA INITIO gross sales.

Product sales of LYBALVI during the year ended December 31, 2023 to Cardinal Health, McKesson Corporation and AmerisourceBergen represented approximately 36%, 31% and 29%, respectively, of total LYBALVI gross sales.

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

Product sales of ARISTADA and ARISTADA INITIO during the year ended December 31, 2024 to McKesson Corporation, Cardinal Health and Cencora represented approximately 38%, 32% and 23%, respectively, of total ARISTADA and ARISTADA INITIO gross sales.

Product sales of LYBALVI during the year ended December 31, 2024 to McKesson Corporation, Cardinal Health and Cencora represented approximately 35%, 32% and 29%, respectively, of total LYBALVI gross sales.

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

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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Some of these competitors are also our licensees, who control the commercialization of products from which we receive manufacturing and/or royalty revenues.

In some cases, these competitors may be working to develop and market other products, systems, and other methods of preventing or reducing disease, and new small-molecule and other classes of drugs.

In some cases, these competitors may be working to develop and market other products, systems, or other methods of preventing or reducing disease, or new small-molecule or other classes of drugs.

The biopharmaceutical industry is characterized by intensive research, development and commercialization efforts and rapid and significant technological change.

In many cases, there are already products on the market that may be in direct competition with our commercial products or products in development.

In addition, there are many companies developing products for use in similar indications or with similar technologies to ours with whom we and our licensees compete, many of whom are larger and have significantly greater financial and other resources than we do.

Other smaller or earlier stage companies may also prove to be significant competitors, particularly through focused development programs and collaborative arrangements with large, established companies.

Some of the products being developed by our competitors are being designed to work differently than our products and may turn out to be safer or more effective than our products, which may render our products or technology platforms obsolete or noncompetitive.

Other smaller or earlier stage companies may also prove to be significant competitors, whether through focused or more abbreviated development programs, or collaborative arrangements with large, established companies.

Some of the products being developed by our competitors are being designed to work differently than our products and may prove to be safer or more effective than our products or achieve regulatory approval and be commercialized earlier than our products, which may render our products or technology platforms obsolete or noncompetitive or make it more challenging for us to commercialize our products.

With respect to our products, we believe that our ability to successfully compete will depend on, among other things, the existence of competing or alternative products in the marketplace, including generic competition, and the relative price of those products;

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

With respect to our proprietary injectable product platform, we are aware that there are other companies developing extended-release delivery systems for pharmaceutical products, including but not limited to technology from Pharmathen S.A., which underpins aripiprazole formulations in development, and technology underpinning Teva Pharmaceuticals Industries Ltd.’s (together with its affiliates, “Teva”) once every two weeks injectable microsphere formulation, each for the treatment of schizophrenia.

With respect to our proprietary injectable product platform, we are aware that there are other companies developing extended-release delivery systems for pharmaceutical products, including but not limited to technology from Pharmathen S.A., which underpins aripiprazole formulations in development, and technology underpinning Teva’s once every two weeks injectable microsphere formulation, each for the treatment of schizophrenia.

In the treatment of schizophrenia, ARISTADA, the long-acting INVEGA products and RISPERDAL CONSTA compete with each other and a number of other injectable products, including ZYPREXA RELPREVV ((olanzapine) For Extended Release Injectable Suspension), which is marketed and sold by Lilly;

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

LATUDA, which is marketed and sold by Sunovion Pharmaceuticals Inc.;

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

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

Lundbeck A/S plc;

VRAYLAR, which is marketed and sold by Abbvie Inc.;

VRAYLAR (cariprazine), which is marketed and sold by Abbvie Inc.;

COBENFY (xanomeline and trospium chloride), which is marketed and sold by Bristol-Myers Squibb Company;

other oral compounds currently on the market;

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Other pharmaceutical companies are developing products for the treatment of schizophrenia that, if approved by the FDA, would compete with LYBALVI.

In the treatment of bipolar disorder, LYBALVI and RISPERDAL CONSTA compete with antipsychotics such as oral aripiprazole;

In the treatment of bipolar I disorder, LYBALVI and RISPERDAL CONSTA compete with antipsychotics such as oral aripiprazole;

ABILIFY MAINTENA;

ABILIFY ASIMTUFII;

ziprasidone and clozapine.

Other pharmaceutical companies are developing products for the treatment of bipolar disorder that, if approved by the FDA, would compete with LYBALVI.

and ziprasidone.

Other pharmaceutical companies are developing products for the treatment of bipolar I disorder that, if approved by the FDA, would compete with LYBALVI.

In the treatment of alcohol dependence, VIVITROL competes with generic acamprosate calcium (also known as CAMPRAL) and generic disulfiram (also known as ANTABUSE) as well as currently marketed drugs, including generic drugs, also formulated from naltrexone.

Other pharmaceutical companies are developing products that have shown some promise in treating alcohol dependence that, if approved by the FDA, would compete with VIVITROL.

Other pharmaceutical companies are developing products that have shown some potential in treating alcohol dependence that, if approved by the FDA, would compete with VIVITROL.

In the treatment of opioid dependence, VIVITROL competes with SUBOXONE (buprenorphine HCl/naloxone HCl dehydrate sublingual tablets), SUBOXONE (buprenorphine/naloxone) Sublingual Film, SUBUTEX (buprenorphine HCl sublingual tablets) and SUBLOCADE (once-monthly buprenorphine extended-release injection), each of which is marketed and sold by Indivior plc;

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VIVITROL also competes with methadone, oral naltrexone and generic versions of SUBUTEX and SUBOXONE sublingual tablets.

Other pharmaceutical companies are developing products that have shown promise in treating opioid dependence that, if approved by the FDA, would compete with VIVITROL.

In the treatment of MS, VUMERITY competes with AVONEX, TYSABRI, TECFIDERA, and PLEGRIDY from Biogen;

OCREVUS from Genentech;

BETASERON from Bayer HealthCare Pharmaceuticals;

COPAXONE from Teva;

REBIF and MAVENCLAD from EMD Serono, Inc.;

GILENYA, EXTAVIA and MAYZENT from Novartis AG;

AUBAGIO and LEMTRADA from Sanofi-Aventis;

ZEPOSIA from Bristol-Myers Squibb Company;

PONVORY from Janssen;

Other pharmaceutical companies are developing products that have shown potential in treating opioid dependence that, if approved by the FDA, would compete with VIVITROL.

In the treatment of MS, VUMERITY competes with AVONEX (interferon beta-1a), TYSABRI (natalizumab), TECFIDERA (dimethyl fumarate), and PLEGRIDY (peginterferon beta-1a) from Biogen;

OCREVUS (ocrelizumab) from Genentech;

BETASERON (interferon beta-1b) from Bayer HealthCare Pharmaceuticals;

COPAXONE (glatiramer acetate) from Teva;

REBIF (interferon beta-1a) and MAVENCLAD (cladribine) from EMD Serono, Inc.;

GILENYA (fingolimod), EXTAVIA (interferon beta-1b) and MAYZENT (siponimod) from Novartis AG;

AUBAGIO (teriflunomide) and LEMTRADA (alemtuzumab) from Sanofi-Aventis;

ZEPOSIA (ozanimod) from Bristol-Myers Squibb Company;

PONVORY (ponesimod) from Janssen;

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

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These approaches include nanoparticles, cyclodextrins, lipid-based self-emulsifying drug delivery systems, dendrimers and micelles, among others, any of which could limit the potential success and growth prospects of products incorporating our NanoCrystal technology.

In addition, there are many competing technologies to our OCR technology, some of which are owned by large pharmaceutical companies with drug delivery divisions and other, smaller drug-delivery-specific companies.

In addition, there are many competing technologies to our OCR technology, some of which are owned by large pharmaceutical companies with drug delivery divisions or other, smaller drug-delivery-specific companies.

Patents and Proprietary Rights

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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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The latest to expire of the patents subject to our license agreement expires in 2030 in the U.S., the EU and certain other countries.

In addition, Janssen has other patents not subject to our license agreement, including one that covers INVEGA SUSTENNA in the U.S.

and expires in 2031, one that covers INVEGA TRINZA in the U.S.

In addition, Janssen has other patents not subject to our license agreement, including, among others, one that covers INVEGA TRINZA in the U.S.

and expires in 2036 and two that cover INVEGA HAFYERA in the U.S.

and expire in 2041.

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

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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Our pending patent applications, those we may file in the future, or those we may license from third parties, may not result in patents being issued.

If issued, they may not provide us with proprietary protection or competitive advantages against competitors with similar technology.

If issued, such patents may not provide us with proprietary protection or competitive advantages against competitors with similar technology.

Furthermore, others may independently develop similar technologies or duplicate any technology that we have developed outside the scope of our patents.

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We also rely on trade secrets, know-how and inventions, which are not protected by patents, to maintain our competitive position.

We try to protect this information by entering into confidentiality agreements with parties that have access to it, such as our corporate partners, collaborators, licensees, employees and consultants.

We try to protect this information by entering into confidentiality agreements with parties that have access to such information, such as our corporate partners, collaborators, licensees, employees and consultants.

However, any of these parties may breach such agreements and may disclose our confidential information or our competitors might learn of the information in some other way.

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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.

Patent and Trademark Office and the patent or trademark offices of other countries.

Our licensed products and products using our proprietary technologies also use trademarks that are owned by our licensees, such as the trademarks for INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA, INVEGA HAFYERA/BYANNLI and RISPERDAL CONSTA, which are registered trademarks of Johnson & Johnson or its affiliated companies, VUMERITY, which is a registered trademark of Biogen (and used by us under license) and FAMPYRA, which is a registered trademark of Acorda.

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

Our licensed products and products using our proprietary technologies also use trademarks that are owned by our licensees, such as the trademarks for INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA, INVEGA HAFYERA/BYANNLI and RISPERDAL CONSTA, which are registered trademarks of Johnson & Johnson or its affiliated companies and VUMERITY, which is a registered trademark of Biogen (and used by us under license).

Trademark protection varies in accordance with local law and continues in some countries as long as the trademark is used and in other countries as long as the trademark is registered.

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Clinical Trials :

Clinical trials involve the administration of a drug to healthy human volunteers or to patients under the supervision of a qualified investigator pursuant to an FDA-reviewed protocol.

Clinical trials involve the administration of an investigational drug to healthy human volunteers or to patients under the supervision of a qualified investigator pursuant to an FDA-reviewed protocol.

Human clinical trials are typically conducted in three sequential phases, although the phases may overlap with one another and, depending upon the nature of the clinical program, a specific phase or phases may be skipped altogether.

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• Phase 3 clinical trials—consist of expanded, large-scale studies of patients with the target disease or disorder to obtain definitive statistical evidence of the efficacy and safety of the proposed product and dosing regimen.

In the U.S., the results of the preclinical and clinical testing of a product are then submitted to the FDA in the form of an NDA or a Biologics License Application (“BLA”).

In the U.S., the results of the preclinical and clinical testing of a product are then submitted to the FDA in the form of a New Drug Application (“NDA”) or a Biologics License Application (“BLA”), depending on the nature of the product.

The NDA or BLA also include information pertaining to the chemistry, manufacturing and controls (“CMC”) of the product as well as the proposed product packaging and labeling.

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Once an NDA or BLA is accepted for filing, the FDA has 10 months, under its standard review process, within which to review the application (for some applications, the review process is longer than 10 months).

For drugs that, if approved, would represent a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications, the FDA may assign “priority review” designation and review the application within six months.

The FDA has additional review pathways to expedite development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs, including:

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The FDA may determine that a Risk Evaluation and Mitigation Strategy (“REMS”) is necessary to ensure that the benefits of a new product outweigh its risks.

If required, a REMS may include various elements, such as publication of a medication guide, a patient package insert, a communication plan to educate health care providers of the drug’s risks, limitations on who may prescribe or dispense the drug, or other measures that the FDA deems necessary to support the safe use of the drug.

If required, a REMS may include various elements, such as publication of a medication guide, a patient package insert, a communication plan to educate healthcare providers of the drug’s risks, limitations on who may prescribe or dispense the drug, or other measures that the FDA deems necessary to support the safe use of the drug.

In reviewing an NDA or BLA, the FDA may grant marketing approval, or issue a complete response letter to communicate to the applicant the reasons the application cannot be approved in its then-current form and provide input on the additional information that the FDA requires and/or changes that must be made before an application can be approved.

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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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In addition, the FDA regulates all advertising and promotional activities for products under its jurisdiction.

A company can make only those claims relating to safety and efficacy that are consistent with FDA regulation and guidance.

A company can make only those claims relating to safety and efficacy that are consistent with FDA regulation and guidance, and the product’s approved label.

However, physicians may prescribe legally available drugs for uses that are not described in the drug’s labeling.

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Good Manufacturing Practices

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 and biologic 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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Under the Orphan Drug Act, the FDA may designate drugs or biologics for relatively small patient populations as orphan drugs.

FDA grants orphan drug designation to drugs or biologics intended to treat a rare disease or condition, which is one that affects fewer than 200,000 individuals in the U.S., or more than 200,000 individuals, but for which there is no reasonable expectation that the cost of developing the product and making it available in the U.S.

FDA grants orphan drug designation to drugs intended to treat a rare disease or condition, which is one that affects fewer than 200,000 individuals in the U.S., or more than 200,000 individuals, but for which there is no reasonable expectation that the cost of developing the product and making it available in the U.S.

for the disease or condition will be recovered from U.S.

sales of the product.

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 FDA.

If a product is approved for its orphan designated use, it may be

entitled to Orphan Drug Exclusivity (“ODE”), which blocks FDA from approving for seven years any other application for a product that is the same drug for the same indication.

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.

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 face costs, penalties and business losses,” “Revenues generated by sales of our products depend 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.”

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.”

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

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The rebate amount is required to be recomputed each quarter based on our report of current AMP and best price for each of our products to the Centers for Medicare & Medicaid Services (“CMS”).

The terms of our participation in the rebate program impose

a requirement on us to report revisions to AMP or best price within a period not to exceed 12 quarters from the quarter in which the data was originally due.

The terms of our participation in the rebate program impose a requirement on us to report revisions to AMP or best price within a period not to exceed 12 quarters from the quarter in which the data was originally due.

Any such revisions could have the impact of increasing or decreasing our rebate liability for prior quarters, depending on the direction of the revision.

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Medicare Part B pays physicians who administer our products under a payment methodology using average sales price (“ASP”) information.

Manufacturers, including us, are required to provide ASP information to the CMS on a quarterly basis.

Manufacturers, including us, are required to provide ASP information to CMS on a quarterly basis.

This information is used to compute Medicare payment rates, with rates for Medicare Part B drugs outside the hospital outpatient setting and in the hospital outpatient setting consisting of ASP plus a specified percentage.

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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.

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.

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.

Medicare Part D also covers the prescription drug benefit for dual eligible beneficiaries.

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The prescription drug plans negotiate pricing with manufacturers and may condition formulary placement on the availability of manufacturer discounts.

Except for dual eligible Medicare Part D beneficiaries who qualify for low-income subsidies, manufacturers, including us, are required to provide a seventy percent (70%) discount on our brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries reach the coverage gap in their drug benefits.

Federal law also requires that any company that participates in the Medicaid Drug Rebate Program also participate in the Public Health Services’ (including the Indian Health Services, “PHS”) pharmaceutical pricing program (the “340B program”), in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B.

The 340B program, which is administered by the Health Resources and Services Administration (“HRSA”) requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered drugs used in an outpatient setting.

The Medicare Part D benefit has distinct phases, where the share of drug costs paid by Medicare Part D enrollees, the Medicare Part D prescription drug plan, drug manufacturers and Medicare varies.

Prior to 2025, the phases consisted of the deductible phase, the initial coverage phase, the coverage gap and the catastrophic coverage phase and, except for dual eligible Medicare Part D beneficiaries who qualified for low-income subsidies, drug manufacturers, including us, were required to provide a seventy percent (70%) discount on our brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries reached the coverage gap in their drug benefits.

The Inflation Reduction Act of 2022 (the “Inflation Reduction Act”) made substantial changes to the Medicare Part D benefit design and replaced the manufacturer coverage-gap discount program with a new manufacturer discount program that took effect in January 2025.

Under the new discount program, the Medicare Part D benefit phases consist of the deductible phase, the coverage phase and the catastrophic coverage phase, and drug manufacturers must provide a ten percent (10%) discount on their brand name prescription drugs utilized by Medicare Part D beneficiaries during the initial coverage phase and a twenty percent (20%) discount during the catastrophic coverage phase.

For manufacturers that meet the definition of a “specified manufacturer,” the Inflation Reduction Act provides for Medicare Part D discounts to be phased in over time, starting with a one percent (1%) discount in the initial coverage phase and a one percent (1%) discount in the catastrophic coverage phase in 2025.

These discount amounts increase each year, stepping up to a ten percent (10%) discount in the initial coverage phase in 2029 and a twenty percent (20%) discount in the catastrophic coverage phase in 2031.

Alkermes meets the criteria of a “specified manufacturer” and, therefore, will follow the phase-in schedule for discounts to the Medicare Part D program.

Federal law also requires that any company that participates in the Medicaid Drug Rebate Program (“MDRP”) also participate in the Public Health Services’ (including the Indian Health Services, “PHS”) pharmaceutical pricing program (the “340B program”), in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B.

The 340B program, which is administered by the Health Resources and Services Administration (“HRSA”), requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered drugs.

These 340B covered entities include certain qualifying community health clinics, a variety of entities that receive health services grants from the Public Health Service, and multiple categories of hospitals, including children’s hospitals, critical access hospitals, free standing cancer hospitals and hospitals that serve a disproportionate share of low-income patients.

The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate Program.

The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and rebate amount for the covered outpatient drug as calculated under the MDRP.

A regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities became effective on January 1, 2019.

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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 exclude from AMP, for those qualifying 5i drugs not generally dispensed through RCPs, certain payments, rebates and discounts related to sales to non-RCPs;

such exclusion often leads to a lower AMP.

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;

such inclusion often leads to a lower AMP.

The decision of which AMP calculation a product is eligible to use must be made and applied on a monthly basis based on the percentage of sales of such product to RCPs or to wholesalers for RCPs.

In September 2024, CMS released a final rule titled “Medicaid Program:

Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program,” the provisions of which generally took effect in November 2024.

The rule includes several provisions affecting manufacturers that participate in the MDRP, including, but not limited to, addressing manufacturer misclassification of their products in reports required by the MDRP, imposing a 12-quarter deadline for manufacturer disputes or audits of state rebate invoices, and modifying the definition of “covered outpatient drugs” for which manufacturers are required to pay rebates to include certain drugs administered in inpatient settings where the drug is part of an inclusive payment, such inclusive payment includes an amount attributable to the drug and the number of units of the drug administered to the patient, and where the amount paid that is attributable to the drug is based on a reimbursement methodology included in the applicable state plan.

federal and state governments regularly consider reforming healthcare coverage and lessening healthcare costs.

Such reforms may include price controls, value-based pricing and changes to the coverage and reimbursement of our products, which may have a significant impact on our business.

In August 2022, the Inflation Reduction Act of 2022 (the “Inflation Reduction Act”) was signed into law.

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.

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The GDPR, which governs the processing of personal data (including personal health data), applies to the Company and any of its subsidiaries that are established in the EU to the extent that they process personal data as well as any of its subsidiaries that are established outside the EU to the extent that they process personal data relating to EU residents for certain purposes, including any such data relating to clinical trial participants in the EU.

mandatory data breach notifications, limitations on the retention of personal data, stringent requirements pertaining to health data, and strict rules and restrictions on the transfer of personal data outside of the EU, including to the U.S.

The GDPR imposes significant obligations on controllers and processors of personal data, including high standards for obtaining consent from individuals to process their personal data, robust notification requirements to individuals about the processing of their personal data, a strong individual data rights regime, mandatory data breach notifications, limitations on the retention of personal data, stringent requirements pertaining to health data, and strict rules and restrictions on the transfer of personal data outside of the EU, including to the U.S.

The GDPR also imposes additional obligations on, and required contractual provisions to be included in, contracts between companies subject to the GDPR and their third-party processors that relate to the processing of personal data.

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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, translational medicine, formulation development, and clinical trials and operations;

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;

IP prosecution, enforcement and defense;

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sales and marketing;

and market access.

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 culture and to providing them with access to training, support and resources intended to help them succeed professionally, while balancing their professional and personal lives.

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.

As of February 7, 2025, we had approximately 1,800 full time employees, of which approximately 1,700 were based in the U.S.

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None of our employees are covered by a collective bargaining agreement, and we consider our relations with our employees to be good.

We are an equal opportunity employer and we are fundamentally committed to creating and maintaining a work environment in which employees are treated with respect and dignity.

We are an equal opportunity employer and fundamentally committed to creating and maintaining a work environment in which employees are treated with respect and dignity.

All human resources policies, practices and actions related to hiring, promotion, compensation, benefits and termination are administered in accordance with the principles of equal employment opportunity and other legitimate criteria without regard to race, color, religion, sex, sexual orientation, gender expression or identity, ethnicity, national origin, ancestry, age, mental or physical disability, genetic information, any veteran status, any military status or application for military service, or membership in any other category protected under applicable laws.

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We routinely monitor our pay programs in order to respond to market trends and maintain equity within our workforce.

We offer healthcare and retirement savings plan benefits, paid time off, tuition reimbursement and other benefits designed to support healthy lifestyle choices, financial well-being and work-life balance.

Across our sites, we seek to cultivate a work environment that reflects our values of collaboration at our core, respect for each voice and unwavering commitment.

Over the past several years, we have continued to focus on fostering an environment that respects and celebrates Diversity, Inclusion & Belonging (“DIB”) in our workplaces and our communities and have actively evolved our DIB strategy and programs to reflect the needs of our employees and our business.

We have a robust DIB governance structure, consisting of our DIB Steering Committee, Employee Resource Groups (“ERGs”), and a DIB Executive Committee.

Our global cross-functional DIB Steering Committee, comprised of representatives from all of our locations (including field-based employees) is focused on creating connections, fostering conversations, helping ensure our efforts are aligned with the diverse range of perspectives within our organization and developing and advancing practices, tools and resources that can be used to strengthen the sense of belonging among our employees.

Our five ERGs include:

We offer our employees healthcare and retirement savings plan benefits, paid time off, tuition reimbursement and other benefits designed to support healthy lifestyle choices, financial well-being and work-life balance.

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:

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

MOSAIC, a multicultural network;

Operation Salute, a veterans’ network;

Operation Salute, a network to support active duty military members, veterans and their families;

Pride@Work, an LGBTQ+ and allies network;

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

These ERGs 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.

Our DIB Executive Committee, which includes our Chief Executive Officer and other senior leaders, is tasked with continuing to refine our DIB strategy and championing its implementation and impact across the business.

These groups work together to set goals, establish and execute strategic initiatives, measure our progress and promote a culture of understanding and inclusion throughout our organization.

Beginning in 2022, through the collaboration of these groups, we introduced an annual performance goal focused on DIB for all senior leaders (Vice President level and above) at Alkermes with an emphasis on talent management, development and engagement.

Additionally, as part of our continued focus on social and racial justice, diversity and inclusion, we have held company-wide town hall conversations, sponsored social, educational and recognition events, supported mentoring and internship opportunities and have enhanced our Company’s diversity education and awareness training.

We remain committed to cultivating and supporting the advancement of a diverse workforce.

We have established a women’s mentoring program to provide internal resources for the continued development of our female talent pool, focused on early-stage leaders.

Additionally, we have continued to focus on increasing the representation of people of color (“POC”) across our workforce and have partnered with outside organizations such as The Partnership and Conexión to support continued leadership development of POC within our organization.

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.

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 the data collected to help inform and evolve our human capital management strategy and initiatives.

We survey employees twice per year, which allows our employees to share their insights on a more regular basis and provides us with opportunities to regularly assess and address employee feedback.

In 2023, we continued function- and site-specific mentoring programs, conducted open forums with leaders, created employee focused information resources connected to major initiatives occurring at the Company and hosted various Company events to foster connections and visibility between leadership and employees and build strong peer-to-peer connections.

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 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.

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

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

Our culture is one of collaboration and trust.

We ask our employees to help us promote and sustain workplace environments that are safe and protective of the health and well-being of our people and in compliance with applicable laws, rules and regulations.

We maintain extensive environmental, health, safety and security policies, adhere to all health and safety standards set by regulators in the locations in which we operate and routinely assess workplace risks, conduct employee trainings and monitor our sites to reduce the risk of workplace accidents.

We ask our employees to help us promote and sustain workplace environments that are safe, productive and protective of the health and well-being of our people and in compliance with applicable laws, rules and regulations.

We maintain extensive corporate environmental, health, safety and security policies, adhere to all health and safety standards set by regulators in the locations in which we operate, and routinely assess workplace risks, conduct employee trainings and monitor our sites to reduce the risk of workplace accidents.

In 2024, employee health, safety and wellness continued to be of particular focus and importance for the Company.

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 employees connected and informed, including frequent leadership communications, forums for reflection on current events, in-person social events, and enhanced employee resources.

Available Information and Website Disclosure

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Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us.

Information that is contained in and can be accessed through our website is not incorporated into, and does not form a part of, this Annual Report.

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