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Alkermes plc.

ALKS
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Business Summary

Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines in the field of neuroscience, with a portfolio of proprietary commercial products and a pipeline of clinical and preclinical candidates . The company's core business model involves generating revenue through the sale of its proprietary products and through manufacturing and royalty revenues from products commercialized by its licensees . The company primarily serves customer segments in the U.S. for its proprietary products, focusing sales and marketing efforts on physicians in private practice and public treatment systems .

Alkermes' proprietary product portfolio includes ARISTADA and ARISTADA INITIO, extended-release intramuscular injectable suspensions for the treatment of schizophrenia, utilizing the proprietary LINKERX technology . ARISTADA is available in four dose strengths with once-monthly, six-week, and two-month dosing options . ARISTADA INITIO, combined with oral aripiprazole, is indicated for the initiation of ARISTADA . LYBALVI (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic approved for the treatment of adults with schizophrenia and bipolar I disorder, available in fixed dosage strengths . VIVITROL (naltrexone for extended-release injectable suspension) is a once-monthly, non-narcotic, injectable medication approved for the treatment of alcohol dependence and the prevention of relapse to opioid dependence . In February 2026, Alkermes completed the acquisition of Avadel Pharmaceuticals plc, adding LUMRYZ (sodium oxybate) to its portfolio, which is an extended-release oral suspension approved as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults and pediatric patients seven years of age and older with narcolepsy . LUMRYZ utilizes the company's MICROPUMP technology .

Key third-party products using Alkermes' proprietary technologies include the long-acting INVEGA products (INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA, and INVEGA HAFYERA/BYANNLI), which are long-acting atypical antipsychotics owned and commercialized worldwide by Janssen for schizophrenia and schizoaffective disorder . RISPERDAL CONSTA (risperidone long-acting injection), also owned and commercialized worldwide by Janssen for schizophrenia and bipolar I disorder, incorporates Alkermes' polymer-based microsphere injectable extended-release technology . Alkermes exclusively manufactures RISPERDAL CONSTA microspheres . The key licensed product is VUMERITY (diroximel fumarate), a novel oral fumarate for the treatment of relapsing forms of multiple sclerosis, for which Biogen holds the exclusive worldwide license .

For the fiscal year ended December 31, 2025, total revenues were $1,475,899 thousand . Product sales, net, amounted to $1,184,643 thousand , while manufacturing and royalty revenues were $291,256 thousand . Cost of goods manufactured and sold was $196,457 thousand , and research and development expenses totaled $323,964 thousand . Selling, general and administrative expenses were $701,522 thousand . Operating income from continuing operations was $253,956 thousand . Net income from continuing operations was $241,664 thousand , with diluted EPS from continuing operations of $1.43 . Cash and cash equivalents stood at $388,570 thousand , and restricted cash was $731,206 thousand . Total cash, restricted cash and investments were $1,319,500 thousand . The company had no long-term debt as of December 31, 2025, following the prepayment of $289,542 thousand in December 2024 .

Comparing 2025 to 2024, product sales, net, increased by $101,100 thousand , driven by a 19% increase in LYBALVI units sold and a 3% price increase for LYBALVI, ARISTADA/ARISTADA INITIO, and VIVITROL . This was partially offset by decreases of 3% and 2% in units sold for VIVITROL and ARISTADA/ARISTADA INITIO, respectively . Manufacturing and royalty revenues decreased by $182,800 thousand , primarily due to a $126,900 thousand decrease in long-acting INVEGA products royalty revenues following the expiration of the INVEGA SUSTENNA U.S. royalty in August 2024 . The cost of goods manufactured and sold decreased by $48,800 thousand , mainly due to a $43,700 thousand decrease in costs for legacy products after the Athlone Facility sale . Research and development expenses increased by $78,700 thousand , largely due to increased spending on the alixorexton development program . Selling, general and administrative expenses increased by $56,300 thousand , primarily from a $33,300 thousand increase in employee-related expenses due to a 10% increase in sales and marketing headcount . Net income from continuing operations decreased by $130,500 thousand from $372,138 thousand in 2024 to $241,664 thousand in 2025 .

In October 2025, Alkermes entered into a definitive transaction agreement with Avadel Pharmaceuticals plc, subsequently amended in November 2025, to acquire Avadel for $21.00 per ordinary share in cash and a non-transferable contingent value right of $1.50 per share . This Avadel Acquisition was successfully completed on February 12, 2026, adding LUMRYZ to Alkermes' commercial portfolio . During the fourth quarter of 2025, Alkermes incurred approximately $10.0 million in costs related to the Avadel Acquisition . In May 2024, Alkermes completed the sale of its Athlone Facility and related business to Novo Nordisk, with subcontracting arrangements for development and manufacturing activities concluding by the end of 2025 .

Business Outlook

Alkermes anticipates that its existing cash, cash equivalents, restricted cash, and investments will be sufficient to finance its anticipated working capital and other cash requirements, including debt services and capital expenditures, for at least the twelve months following the date from which its financial statements were issued . The company expects R&D expense to increase in 2026 .

The company's key development program, alixorexton (formerly ALKS 2680), is a novel, investigational, oral, selective orexin 2 receptor agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) . In 2025, Alkermes completed and announced positive topline data from two phase 2 studies, Vibrance-1 and Vibrance-2, in patients with NT1 and NT2, respectively . The company plans 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 . Additionally, LUMRYZ (sodium oxybate) extended-release oral suspension is being evaluated in REVITALYZ, a double-blind, placebo-controlled, randomized withdrawal, multicenter phase 3 study for adult patients with IH, with patient enrollment completed in December 2025 . Alkermes expects ARISTADA, ARISTADA INITIO, LYBALVI, VIVITROL, VUMERITY, and the newly acquired LUMRYZ to generate significant revenues in the near- and medium-term .

Alkermes expects R&D expense to increase in 2026, as it plans to initiate the phase 3 program for alixorexton and as ALKS 4510 and ALKS 7290, two internal early-stage development candidates which entered the clinic in 2025, advance . The company expects to spend approximately $40.0 million to $50.0 million during the year ending December 31, 2026 for capital expenditures .

Alkermes expects revenues from RISPERDAL CONSTA to continue to decrease as patents covering the product expire in various markets . The company also anticipates generic versions of VIVITROL to enter the market in 2027 , following settlement and license agreements with Teva and Amneal . Alkermes expects royalty revenues related to U.S. net sales of INVEGA TRINZA and INVEGA HAFYERA through certain specified dates in 2030, but total royalty revenues from the long-acting INVEGA products are expected to be lower due to the expiration of INVEGA SUSTENNA U.S. royalty revenues in August 2024 . The OBBBA, enacted in July 2025, imposes significant reductions in Medicaid program funding and the enhanced PPACA subsidies expired as of December 31, 2025, which are expected to decrease Medicaid enrollment and covered services . The U.S. federal government's "Most-Favored-Nation" (MFN) pricing initiatives, including the GLOBE, GUARD, and GENEROUS models, are intended to reduce Medicare and Medicaid drug expenditures and could impact the company's business .

Risk Factors

Alkermes faces numerous material risks, including substantial revenue dependence on key proprietary products like VIVITROL, ARISTADA, ARISTADA INITIO, LYBALVI, and the newly acquired LUMRYZ, with any negative developments potentially having a material adverse effect on revenues . The biopharmaceutical industry is intensely competitive, with many larger companies and generic drug manufacturers posing significant threats, which could render Alkermes' products or technologies obsolete or noncompetitive . Revenues from product sales may decrease or grow slower than expected due to factors such as physician and patient perception of safety and efficacy, unfavorable publicity, cost-effectiveness, regulatory exclusivities (including orphan drug exclusivity for LUMRYZ), and the burdens associated with LUMRYZ's REMS program . Reimbursement policies from third-party payers, including government programs like Medicare and Medicaid, are critical, and any reductions in payment rates, increased cost-sharing for patients, or cost-control measures could decrease sales and revenues . The Inflation Reduction Act of 2022 and the One Big Beautiful Bill Act (OBBBA) of July 2025 introduce new manufacturer financial liabilities, drug price negotiation for Medicare, and reductions in Medicaid funding, all of which could adversely affect Alkermes' business and financial results . The company also faces uncertainties from government MFN pricing initiatives (GLOBE, GUARD, GENEROUS) . The Avadel Acquisition, completed in February 2026, carries integration risks and the potential failure to realize anticipated benefits and synergies, which could adversely affect the business and share price . Compliance with extensive legal and regulatory requirements in the healthcare industry, including anti-kickback and false claims laws, is crucial, and any failure to comply could lead to investigations, litigation, costs, penalties, and business losses . Alkermes relies on licensees for commercialization and development of certain products, and their ineffectiveness or disputes could materially adversely affect revenues . Clinical trials are expensive, lengthy, and uncertain, with preliminary data subject to change, and failure to demonstrate safety and efficacy could delay or prevent commercialization . Manufacturing risks, including supply chain disruptions, regulatory actions, and reliance on single-source suppliers or third-party manufacturers, could lead to product defects, shortages, or delays . LUMRYZ, as a controlled substance, is subject to stringent DEA regulations, and non-compliance or insufficient manufacturing quotas could materially adversely affect the business . The ability to attract and retain key personnel is vital, and loss of such personnel could materially impact business objectives . Patent and other intellectual property protection is uncertain, with risks of challenges, invalidation, infringement claims, and competition from generic drug manufacturers, which could result in significant financial losses or prevent product commercialization . Litigation or arbitration, including securities litigation or citizen petitions against regulatory agencies, can result in financial losses, reputational harm, and diversion of management resources . Unintended side effects, adverse reactions, or misuse of products could lead to recalls, additional regulatory controls, or product liability claims . Failure to comply with reporting and payment obligations under government pricing programs could result in penalties and sanctions . Environmental, health, and safety risks, including liability for contamination, could lead to significant remediation costs and fines . The company may not maintain profitability on a sustained basis due to various factors impacting revenue growth and cost management . The IRS may not agree with Alkermes' foreign corporation tax status, and the separation of its oncology business may not ultimately qualify as tax-free, potentially leading to significant tax liabilities . Debt obligations from the $1.525 billion Facilities incurred in connection with the Avadel Acquisition could adversely affect the business and limit financial flexibility . The market price of ordinary shares is volatile and subject to fluctuations from market, industry, and company-specific factors, including activist shareholder actions . Information security breaches and data privacy non-compliance, including under GDPR, pose risks of liability, operational disruptions, and reputational damage . Changes in global trade policies, including tariffs, could adversely affect business, results of operations, or financial condition . Future pandemics or outbreaks of infectious diseases could materially and adversely affect the business . Material weaknesses in internal control over financial reporting could negatively affect reporting obligations and share price . The increasing use of social media platforms and artificial intelligence tools presents new risks and challenges, including potential regulatory violations and reputational harm .

Management Priorities

Management's message to shareholders emphasizes the company's focus on developing innovative medicines in neuroscience and its commitment to growing and diversifying revenue while effectively managing costs. The successful completion of the Avadel Acquisition on February 12, 2026, is highlighted as a key strategic development, adding LUMRYZ to the proprietary commercial portfolio and a commercial organization with narcolepsy experience . Management anticipates that existing cash, cash equivalents, restricted cash, and investments will be sufficient to finance anticipated working capital and other cash requirements, including debt services and capital expenditures, for at least the next twelve months . Strategic priorities include advancing the R&D pipeline, particularly the planned initiation of the phase 3 program for alixorexton in the first quarter of 2026 , and the advancement of early-stage development candidates ALKS 4510 and ALKS 7290 . The company expects R&D expense to increase in 2026 and plans capital expenditures of approximately $40.0 million to $50.0 million for the year ending December 31, 2026 .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 7, MD&A — Overview
  3. [3] Item 1, Business — Marketing, Sales and Distribution
  4. [4] Item 1, Business — ARISTADA and ARISTADA INITIO
  5. [5] Item 1, Business — ARISTADA and ARISTADA INITIO
  6. [6] Item 1, Business — ARISTADA and ARISTADA INITIO
  7. [7] Item 1, Business — LYBALVI
  8. [8] Item 1, Business — VIVITROL
  9. [9] Item 1, Business — Overview; Item 1, Business — LUMRYZ
  10. [10] Item 1, Business — LUMRYZ
  11. [11] Item 1, Business — Products Using Our Proprietary Technologies
  12. [12] Item 1, Business — RISPERDAL CONSTA
  13. [13] Item 1, Business — RISPERDAL CONSTA
  14. [14] Item 1, Business — VUMERITY
  15. [15] Item 8, Financial Statements and Supplementary Data — Consolidated Statements of Operations and Comprehensive Income
  16. [16] Item 8, Financial Statements and Supplementary Data — Consolidated Statements of Operations and Comprehensive Income
  17. [17] Item 8, Financial Statements and Supplementary Data — Consolidated Statements of Operations and Comprehensive Income
  18. [18] Item 8, Financial Statements and Supplementary Data — Consolidated Statements of Operations and Comprehensive Income
  19. [19] Item 8, Financial Statements and Supplementary Data — Consolidated Statements of Operations and Comprehensive Income
  20. [20] Item 8, Financial Statements and Supplementary Data — Consolidated Statements of Operations and Comprehensive Income
  21. [21] Item 8, Financial Statements and Supplementary Data — Consolidated Statements of Operations and Comprehensive Income
  22. [22] Item 8, Financial Statements and Supplementary Data — Consolidated Statements of Operations and Comprehensive Income
  23. [23] Item 8, Financial Statements and Supplementary Data — Consolidated Statements of Operations and Comprehensive Income
  24. [24] Item 7, MD&A — Liquidity and Capital Resources
  25. [25] Item 7, MD&A — Liquidity and Capital Resources
  26. [26] Item 7, MD&A — Liquidity and Capital Resources
  27. [27] Item 7, MD&A — Debt
  28. [28] Item 7, MD&A — Product Sales, Net
  29. [29] Item 7, MD&A — Product Sales, Net
  30. [30] Item 7, MD&A — Product Sales, Net
  31. [31] Item 7, MD&A — Manufacturing and Royalty Revenues
  32. [32] Item 7, MD&A — Manufacturing and Royalty Revenues
  33. [33] Item 7, MD&A — Cost of Goods Manufactured and Sold
  34. [34] Item 7, MD&A — Cost of Goods Manufactured and Sold
  35. [35] Item 7, MD&A — Research and Development Expenses
  36. [36] Item 7, MD&A — Research and Development Expenses
  37. [37] Item 7, MD&A — Selling, General and Administrative Expenses
  38. [38] Item 7, MD&A — Selling, General and Administrative Expenses
  39. [39] Item 7, MD&A — Overview
  40. [40] Item 8, Financial Statements and Supplementary Data — Consolidated Statements of Operations and Comprehensive Income
  41. [41] Item 1, Business — Overview
  42. [42] Item 1, Business — Overview
  43. [43] Item 1, Business — Overview
  44. [44] Item 1, Business — Manufacturing and Product Supply
  45. [45] Item 7, MD&A — Sources and Uses of Cash
  46. [46] Item 7, MD&A — Research and Development Expenses
  47. [47] Item 1, Business — Alixorexton (formerly referred to as ALKS 2680)
  48. [48] Item 1, Business — Alixorexton (formerly referred to as ALKS 2680)
  49. [49] Item 1, Business — Alixorexton (formerly referred to as ALKS 2680)
  50. [50] Item 1, Business — Alixorexton (formerly referred to as ALKS 2680)
  51. [51] Item 1, Business — Alixorexton (formerly referred to as ALKS 2680)
  52. [52] Item 1, Business — LUMRYZ (sodium oxybate)
  53. [53] Item 7, MD&A — Overview
  54. [54] Item 7, MD&A — Research and Development Expenses
  55. [55] Item 7, MD&A — Investing Activities
  56. [56] Item 7, MD&A — Manufacturing and Royalty Revenues
  57. [57] Item 7, MD&A — Product Sales, Net
  58. [58] Item 7, MD&A — Product Sales, Net
  59. [59] Item 7, MD&A — Manufacturing and Royalty Revenues
  60. [60] Item 1A, Risk Factors — 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.
  61. [61] Item 1A, Risk Factors — 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.
  62. [62] Item 1A, Risk Factors — We receive substantial revenue from our key proprietary products and our success depends on our ability to successfully manufacture and commercialize such products.
  63. [63] Item 1A, Risk Factors — We face competition in the biopharmaceutical industry.
  64. [64] Item 1A, Risk Factors — Our revenues from sales of our products may decrease or grow at a slower than expected rate due to many factors.
  65. [65] Item 1A, Risk Factors — 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.
  66. [66] Item 1A, Risk Factors — 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.
  67. [67] Item 1A, Risk Factors — 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.
  68. [68] Item 1A, Risk Factors — We may fail to realize some or all of the anticipated benefits and synergies of the Avadel Acquisition or to successfully integrate Avadel’s business, which could adversely affect our business and financial condition and the price of our ordinary shares.
  69. [69] Item 1A, Risk Factors — 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.
  70. [70] Item 1A, Risk Factors — We rely on our licensees in the commercialization and continued development of products from which we receive revenue and, if our licensees are not effective, or if disputes arise in respect of our contractual arrangements, our revenues could be materially adversely affected.
  71. [71] Item 1A, Risk Factors — Clinical trials for our products are expensive, may take several years to complete, and their outcomes are uncertain.
  72. [72] Item 1A, Risk Factors — We are subject to risks related to the manufacture of our products.
  73. [73] Item 1A, Risk Factors — LUMRYZ is a controlled substance subject to U.S. federal and state-controlled substance laws and regulations, and any failure to comply with these laws and regulations, or the cost of compliance with these laws and regulations, could materially adversely affect our business, financial condition, cash flows and results of operations.
  74. [74] Item 1A, Risk Factors — Our success largely depends upon our ability to attract, recognize and retain key personnel.
  75. [75] Item 1A, Risk Factors — Patent and other IP protection for our products is key to our business and our competitive position but is uncertain.
  76. [76] Item 1A, Risk Factors — 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.
  77. [77] Item 1A, Risk Factors — 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.
  78. [78] Item 1A, Risk Factors — If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  79. [79] Item 1A, Risk Factors — Our business involves environmental, health and safety risks.
  80. [80] Item 1A, Risk Factors — We may not be able to maintain profitability on a sustained basis.
  81. [81] Item 1A, Risk Factors — The IRS may not agree with our conclusion that we should be treated as a foreign corporation for U.S. federal income tax purposes.
  82. [82] Item 1A, Risk Factors — Our debt obligations could adversely affect our business and limit our ability to plan for or respond to changes in our business.
  83. [83] Item 1A, Risk Factors — The market price of our ordinary shares has been volatile and may continue to be volatile in the future, and could decline significantly.
  84. [84] Item 1A, Risk Factors — Information security breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation to suffer.
  85. [85] Item 1A, Risk Factors — Changes in global trade or other policies, including tariffs or other restrictions imposed by the U.S. government or governments of other nations, could have an adverse effect on our business, results of operations, or financial condition.
  86. [86] Item 1A, Risk Factors — A future pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our business, financial condition and results of operations.
  87. [87] Item 1A, Risk Factors — If we identify a material weakness in our internal control over financial reporting, our ability to meet our reporting obligations and the trading price of our ordinary shares could be negatively affected.
  88. [88] Item 1A, Risk Factors — The increasing use of social media platforms and artificial intelligence tools present new risks and challenges.
  89. [89] Item 1, Business — Overview
  90. [90] Item 7, MD&A — Sources and Uses of Cash
  91. [91] Item 1, Business — Alixorexton (formerly referred to as ALKS 2680)
  92. [92] Item 7, MD&A — Research and Development Expenses
  93. [93] Item 7, MD&A — Research and Development Expenses
  94. [94] Item 7, MD&A — Investing Activities

Analysis on 5/19/2026