Alkermes plc.
For the period ended Sep 30, 2025. Filed Oct 28, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Oct 28, 2025
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Notes to Condensed Consolidated Financial Statements
- THE COMPANY
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. Alkermes has 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, Alkermes also has a corporate office and research and development (“R&D”) center in Massachusetts and a manufacturing facility in Ohio.
In May 2024, the Company completed the sale of its research and development business and manufacturing facility in Athlone, Ireland (the “Athlone Facility”) to Novo Nordisk (“Novo”). The Company and Novo also 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 activities may continue through the end of 2025. In connection with the sale of the Athlone Facility, the Company received approximately $97.9 million from Novo, which included a payment of approximately $91.0 million for the facility and certain related assets, and recorded a gain of approximately $1.5 million within “Other (expense) income, net” in the accompanying condensed consolidated statements of income and comprehensive income for the nine months ended September 30, 2024.
- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying condensed consolidated financial statements of the Company for the three and nine months ended September 30, 2025 and 2024 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2024. The year-end consolidated balance sheet data, which is presented for comparative purposes, was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the U.S. (commonly referred to as “GAAP”). In the opinion of management, the condensed consolidated financial statements include all adjustments of a normal recurring nature that are necessary to state fairly the results of operations for the reported periods.
The accompanying condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto of the Company, which are contained in the Annual Report. The results of the Company’s operations for any interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for any full fiscal year.
Principles of Consolidation
The accompanying condensed consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries as disclosed in Note 2, Summary of Significant Accounting Policies in the “Notes to Consolidated Financial Statements” accompanying the Annual Report. Intercompany accounts and transactions have been eliminated. Columns and rows within tables may not sum due to rounding.
Discontinued Operations
The Company determined that the separation of its former oncology business into Mural Oncology plc (“Mural”), a new, independent, publicly-traded company (the “Separation”), completed in November 2023, met the criteria for classification of the oncology business as discontinued operations in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Discontinued Operations(“Topic 205”).
Use of Estimates
The preparation of the Company’s condensed consolidated financial statements in accordance with GAAP requires that Company management make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies, including, but not limited to, those related to revenue from contracts with its customers and related allowances, impairment of long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different conditions or using different assumptions.
Segment Information
Operating segments are defined as components of an enterprise engaging in business activities for which separate financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company has utilized the management approach to determine that the Company is managed asone segment on a consolidated basis and is in the business of developing, manufacturing and commercializing medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. The Company’s CODM, the Chairman and Chief Executive Officer, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit. The Company’s CODM measures profitability on a reportable segment basis using net income and utilizes this information in allocating resources and in assessing performance by monitoring budget versus actual results. Please refer to Note 15, Segment Reporting, in these “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for further information.
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies that are adopted by the Company on or prior to the specified effective date. Unless otherwise described in this Form 10-Q, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
In December 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to enhance the transparency and decision usefulness of income tax disclosures in order to provide information to assist key stakeholders in better assessing how the Company’s operations and related tax risks and tax planning and operational opportunities affect the Company’s tax rate and prospects for future cash flows. This ASU becomes effective for public companies for annual periods beginning after December 15, 2024. This guidance will be applied on a prospective basis. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement -Reporting Comprehensive Income-Expense Disaggregation Disclosures, to improve disclosures about public business entity expenses and address requests from investors for more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization and depletion) in commonly-presented expense captions, such as cost of sales, selling, general and administrative expenses, and research and development. All disclosure requirements under this guidance are required for public business entities and will be effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted and the amendments in this guidance will be applied prospectively to financial statements for periods after the effective dates. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU 2025-06, Targeted Improvements to the Accounting for Internal-Use Software. This ASU updates the requirements for capitalization of internal-use software, removing all reference to prescriptive and sequential software development stages (referred to as “project stages”). This ASU is effective for annual periods beginning after December 15, 2027, and for interim periods within those fiscal years. The Company is currently assessing the impact this ASU will have on its consolidated financial statements and related disclosures.
- DISCONTINUED OPERATIONS
Mural Oncology Separation
In connection with the Separation, the Company and Mural entered into, among other agreements: a separation agreement; a tax matters agreement; and an employee matters agreement, which are described in Note 3, Discontinued Operations in the “Notes to Consolidated Financial Statements” accompanying the Annual Report.
Discontinued Operations
The Company determined that the Separation met the criteria for classification of its former oncology business as discontinued operations in accordance with Topic 205. During the three and nine months ended September 30, 2025, the Company recorded no losses from discontinued operations. The following summarizes the losses from discontinued operations for the three and nine months ended September 30, 2024:
| Three Months Ended | Nine Months Ended | |
|---|---|---|
| (In thousands) | September 30, 2024 | September 30, 2024 |
| Operating expenses from discontinued operations | ||
| Cost of goods manufactured | $— | $— |
| Research and development | 481 | 6,910 |
| Selling, general and administrative | — | — |
| Total operating expenses from discontinued operations | 481 | 6,910 |
| Operating loss from discontinued operations | (481) | (6,910) |
| Income tax benefit from discontinued operations | (67) | (1,076) |
| Net loss and comprehensive loss from discontinued operations | $(414) | $(5,834) |
- REVENUE FROM CONTRACTS WITH CUSTOMERS
The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed in accordance with FASB ASC 606, Revenue from Contracts with Customers, or Topic 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations.
Product Sales, Net
The Company’s product sales, net consist of sales in the U.S. of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI, primarily to wholesalers, specialty distributors and pharmacies. Product sales, net are recognized when the customer obtains control of the product, which is when the product has been received by the customer.
During thethree and nine months ended September 30, 2025 and 2024, the Company recorded product sales, net, as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (In thousands) | 2025 | 2024 | 2025 | 2024 |
| VIVITROL | $121,125 | $113,650 | $343,781 | $323,182 |
| ARISTADA and ARISTADA INITIO | 98,050 | 84,652 | 272,820 | 249,571 |
| LYBALVI | 98,248 | 74,697 | 252,550 | 203,055 |
| Total product sales, net | $317,423 | $272,999 | $869,151 | $775,808 |
Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers, healthcare providers or payers. The Company’s process for estimating reserves established for these variable consideration components does not differ materially from historical practices. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. See the “Revenue from Contracts with Customers” section in Note 2, Summary of Significant Accounting Policiesin the “Notes to Consolidated Financial Statements” in the Annual Report for information with respect to the Company’s significant categories of sales discounts and allowances.
Actual Medicaid rebates related to VIVITROL and ARISTADA/ARISTADA INITIO during the nine months ended September 30, 2025 were lower than original estimates, and as a result the Company reduced its rebate reserve for each product by approximately $25.3 million and $12.1 million, respectively, during the period.
A rollfor ward of the Company’s provisions for sales discounts and allowances is as follows:
| (In thousands) | Contractual Adjustments(1) | Discounts(2) | Product Returns | Other | Total |
|---|---|---|---|---|---|
| Beginning balance — December 31, 2024 | $228,978 | $43,645 | $50,507 | $13,297 | $336,427 |
| Current provisions relating to sales in current year | 404,353 | 312,419 | 19,841 | 67,803 | 804,416 |
| Adjustments relating to prior years | (34,939) | 156 | (7,302) | (373) | (42,458) |
| Payments relating to sales in current year | (260,213) | (293,195) | — | (55,560) | (608,968) |
| Payments relating to sales in prior years | (127,928) | (23,940) | (9,569) | (12,512) | (173,949) |
| Ending balance — September 30, 2025 | $210,251 | $39,085 | $53,477 | $12,655 | $315,468 |
“Contractual Adjustments” include “Medicaid Rebates” and “Medicare Part D” accruals.
“Discounts” include “Chargebacks” and “Product Discounts.”
Total revenue-related reserves as of September 30, 2025 and December 31, 2024 included in the accompanying consolidated balance sheets are summarized as follows:
| September 30, | December 31, | |
|---|---|---|
| (In thousands) | 2025 | 2024 |
| Reduction of accounts receivable | $19,249 | $22,031 |
| Components of accrued sales discounts, allowances and reserves | 252,743 | 272,452 |
| Components of other long-term liabilities | 43,476 | 41,944 |
| Total revenue-related reserves | $315,468 | $336,427 |
Manufacturing and Royalty Revenues
During thethree and nine months ended September 30, 2025 and 2024, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows:
| Three Months Ended September 30, 2025 | Nine Months Ended September 30, 2025 | |||||
|---|---|---|---|---|---|---|
| (In thousands) | ManufacturingRevenue | RoyaltyRevenue | Total | ManufacturingRevenue | RoyaltyRevenue | Total |
| Long-acting INVEGA products(1) | $— | $30,180 | $30,180 | $— | $78,240 | $78,240 |
| VUMERITY | 3,494 | 32,122 | 35,616 | 16,852 | 85,996 | 102,848 |
| RISPERDAL CONSTA | 3,732 | 19 | 3,751 | 16,659 | 41 | 16,700 |
| Other | 1,562 | 5,653 | 7,215 | 9,171 | 15,242 | 24,413 |
| $8,788 | $67,974 | $76,762 | $42,682 | $179,519 | $222,201 | |
| Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2024 | |||||
|---|---|---|---|---|---|---|
| (In thousands) | ManufacturingRevenue | RoyaltyRevenue | Total | ManufacturingRevenue | RoyaltyRevenue | Total |
| Long-acting INVEGA products(1) | $— | $58,448 | $58,448 | $— | $199,860 | $199,860 |
| VUMERITY | 8,753 | 23,821 | 32,574 | 30,740 | 68,322 | 99,062 |
| RISPERDAL CONSTA | 2,417 | 11 | 2,428 | 8,440 | 264 | 8,704 |
| Other | 4,777 | 6,917 | 11,694 | 27,077 | 17,132 | 44,209 |
| $15,947 | $89,197 | $105,144 | $66,257 | $285,578 | $351,835 | |
(1)
“long-acting INVEGA products”: INVEGA SUSTENNA/XEPLION (paliperidone palmitate), INVEGA TRINZA/TREVICTA (paliperidone palmitate) and INVEGA HAFYERA/BYANNLI (paliperidone palmitate).
In August 2024, the Company’s royalty on U.S. net sales of INVEGA SUSTENNA expired. Accordingly, royalty revenues from net sales of the long-acting INVEGA products have been, and the Company expects will continue to be, lower in 2025, as the royalty revenues related to U.S. net sales of INVEGA SUSTENNA comprised a significant portion of the overall royalty revenues from the long-acting INVEGA products.
Contract Assets
Contract assets include unbilled amounts related to the manufacture of a product that, once complete, will be sold under certain of the Company’s manufacturing contracts. The amounts included in the contract assets table below are classified as “Current assets” in the accompanying condensed consolidated balance sheets, as they relate to manufacturing processes that are completed inten days toeight weeks.
Total contract assets at September 30, 2025 were as follows:
| (In thousands) | Contract Assets |
|---|---|
| Contract assets at December 31, 2024 | $4,990 |
| Additions | 4,483 |
| Transferred to receivables, net | (8,756) |
| Contract assets at September 30, 2025 | $717 |
Contract Liabilities
Contract liabilities consist of contractual obligations related to deferred revenue. At September 30, 2025 and December 31, 2024, none and $1.2 million of the contract liabilities, respectively, were classified as “Contract liabilities–short-term” in the accompanying condensed consolidated balance sheets andnone of the contract liabilities in either period were classified as “Other long-term liabilities” in the accompanying condensed consolidated balance sheets.
Total contract liabilities at September 30, 2025 were as follows:
| (In thousands) | Contract Liabilities |
|---|---|
| Contract liabilities at December 31, 2024 | $1,249 |
| Additions | 1,313 |
| Amounts recognized into revenue | (2,562) |
| Contract liabilities at September 30, 2025 | $— |
- INVESTMENTS
Investments consist of the following (in thousands):
| Gross Unrealized | |||||
|---|---|---|---|---|---|
| Losses | |||||
| Amortized · Less than · Greater than · Estimated | |||||
| September 30, 2025 | Cost | Gains | One Year | One Year | Fair Value |
| Short-term investments: | |||||
| Available-for-sale securities: | |||||
| U.S. government and agency debt securities | $273,690 | $1,032 | $(3) | $(6) | $274,713 |
| Corporate debt securities | 218,685 | 1,268 | — | (1) | 219,952 |
| Total short-term investments | 492,375 | 2,300 | (3) | (7) | 494,665 |
| Long-term investments: | |||||
| Available-for-sale securities: | |||||
| U.S. government and agency debt securities | 10,062 | — | (4) | (6) | 10,052 |
| Corporate debt securities | 17,690 | — | (5) | (13) | 17,672 |
| 27,752 | — | (9) | (19) | 27,724 | |
| Held-to-maturity securities: | |||||
| Certificates of deposit | 145 | — | — | — | 145 |
| Total long-term investments | 27,897 | — | (9) | (19) | 27,869 |
| Total investments | $520,272 | $2,300 | $(12) | $(26) | $522,534 |
| Short-term investments: | |||||
| Available-for-sale securities: | |||||
| U.S. government and agency debt securities | $266,506 | $763 | $(58) | $(6) | $267,205 |
| Corporate debt securities | 192,617 | 762 | (58) | (4) | 193,317 |
| Total short-term investments | 459,123 | 1,525 | (116) | (10) | 460,522 |
| Long-term investments: | |||||
| Available-for-sale securities: | |||||
| U.S. government and agency debt securities | 48,856 | — | — | (179) | 48,677 |
| Corporate debt securities | 24,484 | — | — | (158) | 24,326 |
| 73,340 | — | — | (337) | 73,003 | |
| Held-to-maturity securities: | |||||
| Certificates of deposit | 145 | — | — | — | 145 |
| Total long-term investments | 73,485 | — | — | (337) | 73,148 |
| Total investments | $532,608 | $1,525 | $(116) | $(347) | $533,670 |
At September 30, 2025, the Company’s investments in corporate debt securities had a minimum rating of A2 (Moody’s)/A (Standard and Poor’s), and 26 of the Company’s 322 investment securities were in an unrealized loss position with an aggregate estimated fair value of $45.0 million. The primary reason these securities were in an unrealized loss position is that they are fixed-rate securities that were acquired in a rising interest rate environment. In making the determination whether the decline in fair value of these securities was temporary, the Company evaluated whether it intended to sell the security and whether it was more likely than not that the Company would be required to sell the security before recovering its amortized cost basis. The Company has the intent and ability to hold these investments until recovery, which may be at maturity.
Realized gains and losses on the sales and maturities of investments, which were identified using the specific identification method, were as follows:
| Nine Months Ended September 30, | ||
|---|---|---|
| (In thousands) | 2025 | 2024 |
| Proceeds from the sales and maturities of investments | $320,383 | $224,786 |
| Realized gains | $4 | $— |
| Realized losses | $— | $— |
The Company’s available-for-sale and held-to-maturity securities at September 30, 2025 had contractual maturities in the following periods:
| Available-for-sale | Held-to-maturity | |||
|---|---|---|---|---|
| Amortized | Estimated | Amortized | Estimated | |
| (In thousands) | Cost | Fair Value | Cost | Fair Value |
| Within 1 year | $247,712 | $248,291 | $145 | $145 |
| After 1 year through 5 years | 272,415 | 274,098 | — | — |
| Total | $520,127 | $522,389 | $145 | $145 |
In February 2025, the Company entered into an agreement whereby it is committed to provide up to €10.0 million to a partnership, Fountain Healthcare Partners Fund IV, L.P. (“Fountain”), which was created to carry on the business of investing exclusively in companies and businesses engaged in the healthcare, pharmaceutical and life sciences sectors. The Company’s commitment represents approximately 9.2% of the partnership’s total funding, and the Company is accounting for its investment in Fountain under the equity method. During each of the three and nine months ended September 30, 2025, the Company recorded a decrease in its investment in Fountain of approximately $0.1 million. The changes recorded represent the Company’s proportional share of Fountain’s net losses for these periods. As of September 30, 2025, the Company had made payments of, and its investment is equal to, $0.5 million (€0.4 million), which is included within “Other assets” in the accompanying condensed consolidated balance sheets.
- FAIR VALUE
The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value hierarchy and the valuation techniques that the Company utilized to determine such fair value:
| September 30, | ||||
|---|---|---|---|---|
| (In thousands) | 2025 | Level 1 | Level 2 | Level 3 |
| Assets: | ||||
| Cash equivalents | $186,317 | $186,317 | $— | $— |
| U.S. government and agency debt securities | 284,765 | 250,937 | 33,828 | — |
| Corporate debt securities | 237,624 | — | 237,124 | 500 |
| Total | $708,706 | $437,254 | $270,952 | $500 |
| December 31, | ||||
|---|---|---|---|---|
| 2024 | Level 1 | Level 2 | Level 3 | |
| Assets: | ||||
| Cash equivalents | $8,388 | $8,388 | $— | $— |
| U.S. government and agency debt securities | 315,882 | 265,090 | 50,792 | — |
| Corporate debt securities | 217,643 | — | 217,643 | — |
| Total | $541,913 | $273,478 | $268,435 | $— |
The Company transfers its financial assets and liabilities, measured at fair value on a recurring basis, between the fair value hierarchies at the end of each reporting period. There wereno transfers of any securities between levels during thenine months ended September 30, 2025.
The following table is a rollforward of the fair value of the Company’s assets with fair values that were determined using Level 3 inputs at September 30, 2025:
| (In thousands) | Fair Value |
|---|---|
| Balance, January 1, 2025 | $— |
| Purchase of a corporate debt security | 500 |
| Balance, September 30, 2025 | $500 |
The Company’s investments classified as Level 2 within the fair value hierarchy were initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing market-observable data. The market-observable data included reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validated the prices developed using the market-observable data by obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active.
The carrying amounts reflected in the accompanying condensed consolidated balance sheets for cash and cash equivalents, accounts receivable, contract assets, other current assets, accounts payable and accrued expenses, sales discounts, allowances and reserves approximate fair value due to their short-term nature.
- INVENTORY
Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Inventory consists of the following:
| September 30, | December 31, | |
|---|---|---|
| (In thousands) | 2025 | 2024 |
| Raw materials | $66,225 | $72,139 |
| Work in process | 89,413 | 79,871 |
| Finished goods(1) | 35,359 | 30,877 |
| Total inventory | $190,997 | $182,887 |
(1)
At September 30, 2025 and December 31, 2024, the Company had $29.3 million and $22.7 million, respectively, of finished goods inventory located at its third-party warehouse and shipping service provider.
- PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consist of the following:
| September 30, | December 31, | |
|---|---|---|
| (In thousands) | 2025 | 2024 |
| Land | $957 | $957 |
| Building and improvements | 150,324 | 134,699 |
| Furniture, fixtures and equipment | 267,641 | 244,113 |
| Leasehold improvements | 42,535 | 42,416 |
| Construction in progress | 49,119 | 58,391 |
| Subtotal | 510,576 | 480,576 |
| Less: accumulated depreciation | (263,594) | (253,012) |
| Total property, plant and equipment, net | $246,982 | $227,564 |
- LEASES
Future lease payments under non-cancelable leases at September 30, 2025 consist of the following:
| September 30, | |
|---|---|
| (In thousands) | 2025 |
| 2025 | 2,585 |
| 2026 | 10,479 |
| 2027 | 9,613 |
| 2028 | 9,677 |
| 2029 | 9,611 |
| Thereafter | 50,371 |
| Total operating lease payments | $92,336 |
| Less: imputed interest | (20,738) |
| Total operating lease liabilities | $71,598 |
At September 30, 2025, the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were 3.7% and 6.1 years, respectively. Cash paid for lease liabilities was $2.6 million and $7.7 million during the three and nine months ended September 30, 2025, respectively, as compared to $2.5 million and $7.6 million during the three and nine months ended September 30, 2024, respectively. The Company recorded operating lease expense from continuing operations of $1.9 million and $5.6 million during the three and nine months ended September 30, 2025, respectively, as compared to $1.8 million and $5.4 million during the three and nine months ended September 30, 2024, respectively.
- ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
| September 30, | December 31, | |
|---|---|---|
| (In thousands) | 2025 | 2024 |
| Accounts payable | $67,998 | $45,630 |
| Accrued compensation | 67,197 | 70,960 |
| Accrued other | 79,790 | 68,742 |
| Total accounts payable and accrued expenses | $214,985 | $185,332 |
A summary of the Company’s current provision for sales discounts, allowances and reserves was as follows:
| September 30, | December 31, | |
|---|---|---|
| (In thousands) | 2025 | 2024 |
| Medicaid rebates | $191,430 | $202,044 |
| Product discounts | 17,711 | 19,351 |
| Medicare Part D | 18,821 | 26,933 |
| Other | 24,781 | 24,124 |
| Total accrued sales discounts, allowances and reserves | $252,743 | $272,452 |
Included in accounts payable was approximately $31.3 million and $11.4 million of amounts payable related to state U.S. Medicaid rebates as of September 30, 2025 and December 31, 2024, respectively.
- SHAREHOLDERS’ EQUITY
In February 2024, the Company announced approval by its board of directors of a share repurchase program authorizing the Company to repurchase its ordinary shares in an aggregate amount of up to $400.0 million(exclusive of any fees, commissions or other expenses related to such repurchases) from time to time (the “Repurchase Program”), with the specific timing and amounts of repurchases under the Repurchase Program dependent on a variety of factors, including but not limited to ongoing assessments of the Company’s needs, alternative investment opportunities, the market price of its ordinary shares and general market conditions. The Repurchase Program has no set expiration date andmay be suspended or discontinued at any time. During the nine months ended September 30, 2025, the Company didnot repurchase any of its ordinary shares under the Repurchase Program. During the nine months ended September 30, 2024, the Company repurchased approximately $7.9 million of its ordinary shares under the Repurchase Program at an average purchase price of $25.33 per share, resulting in a total cost, exclusive of any fees, commissions or other expenses related to such repurchase, of $200.0 million. As of September 30, 2025, the remaining amount authorized under the Repurchase Program was $200.0 million.
On May 21, 2025, the Company’s shareholders approved an amended version of the Alkermes plc 2018 Stock Option and Incentive Plan that served to, among other things, increase the number of ordinary shares authorized for issuance thereunder by 4,250,000.
- SHARE-BASED COMPENSATION
The following table presents share-based compensation expense included in the accompanying condensed consolidated statements of income and comprehensive income:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| (In thousands) | 2025 | 2024 | 2025 | 2024 |
| Cost of goods manufactured and sold | $1,621 | $1,653 | $4,882 | $4,280 |
| Research and development | 6,435 | 6,148 | 18,836 | 22,447 |
| Selling, general and administrative | 16,608 | 14,732 | 48,723 | 49,162 |
| Total share-based compensation expense | $24,664 | $22,533 | $72,441 | $75,889 |
At September 30, 2025 and December 31, 2024, $3.3 million and $3.1 million, respectively, of share-based compensation expense was capitalized and recorded as “Inventory”, and $1.2 million andnone, respectively, of share-based compensation expense was capitalized and recorded as “Property, plant and equipment, net” in the accompanying condensed consolidated balance sheets.
- EARNINGS PER ORDINARY SHARE
Basic earnings per ordinary share from continuing operations is calculated based upon net income from continuing operations available to holders of ordinary shares, divided by the weighted average number of ordinary shares outstanding. Basic loss per ordinary share from discontinued operations is calculated based upon net loss from discontinued operations available to holders of ordinary shares, divided by the weighted average number of ordinary shares outstanding. For the calculation of diluted earnings (loss) per ordinary share from continuing operations and discontinuing operations, the Company utilizes the treasury stock method and adjusts the weighted average number of ordinary shares outstanding for the potential dilutive effect of outstanding ordinary share equivalents such as stock options and restricted stock unit awards.
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| (In thousands) | 2025 | 2024 | 2025 | 2024 |
| Numerator: | ||||
| Net income from continuing operations | $82,761 | $92,795 | $192,323 | $226,401 |
| Net loss from discontinued operations | — | (414) | — | (5,834) |
| Net income | $82,761 | $92,381 | $192,323 | $220,567 |
| Denominator: | ||||
| Weighted average number of ordinary shares outstanding | 165,086 | 163,368 | 164,490 | 166,546 |
| Effect of dilutive securities: | ||||
| Stock options | 1,457 | 1,310 | 1,822 | 1,293 |
| Restricted stock unit awards | 1,967 | 2,347 | 2,133 | 2,357 |
| Dilutive ordinary share equivalents | 3,424 | 3,657 | 3,955 | 3,650 |
| Shares used in calculating diluted earnings per ordinary share | 168,510 | 167,025 | 168,445 | 170,196 |
The following potential ordinary share equivalents were not included in the net earnings per ordinary share calculation because the effect would have been anti-dilutive:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| (In thousands) | 2025 | 2024 | 2025 | 2024 |
| Stock options | 9,668 | 11,047 | 9,711 | 12,311 |
| Restricted stock unit awards | 2,020 | 1,276 | 2,575 | 2,401 |
| Total | 11,688 | 12,323 | 12,286 | 14,712 |
- INCOME TAXES
The Company recognizes income taxes under the asset and liability method. Deferred income taxes are recognized for differences between the financial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. In determining future taxable income, the Company is responsible for assumptions that it utilizes, including the amount of Irish and non-Irish pre-tax operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates that the Company uses to manage the underlying business.
The Company recorded income tax provisions on income from continuing operations of $18.0 million and $38.8 million during the three and nine months ended September 30, 2025, respectively, and of $17.4 million and $47.5 million during the three and nine months ended September 30, 2024, respectively. The income tax provisions during each of the three and nine months ended September 30, 2025 and 2024 were primarily attributable to taxes on income earned in Ireland.
The Company’s effective tax rate during the nine months ended September 30, 2025 and 2024 was 16.8% and 17.3%, respectively. The decrease in the effective tax rate was primarily due to an increase in windfall benefits from employee equity activity and an expense recorded in 2024 related to the sale of the Athlone Facility. The effective tax rates during the nine months ended September 30, 2025 and 2024 exceeded the Irish statutory tax rate of 12.5%, primarily due to non-deductible expenses and income that was taxable at rates higher than the Irish statutory tax rate.
On July 4, 2025, the One Big Beautiful Bill Act (the “OBBBA”) was signed into law. This legislation permanently extends, with modifications, several individual, business, and international tax provisions originally enacted under the Tax Cuts and Jobs Act of 2017. As of September 30, 2025, the Company analyzed the impact of this legislation and determined that the OBBBA did not have a material impact on its effective tax rate for the current year.
- SEGMENT REPORTING
Segment Information
Following the adoption of ASU 2023-07, the Company is required to disclose significant segment expenses that are regularly provided to its CODM. The Company’s CODM is periodically provided R&D expenses, selling and marketing expenses, and general and administrative expenses. Other external R&D expenses are composed of general research and development expenses and other external projects. Other internal R&D expenses include allocation expenses, travel expenses, and fees, taxes and dues.
The Company’s significant segment expenses are as follows:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| (In thousands) | 2025 | 2024 | 2025 | 2024 |
| REVENUES: | ||||
| Total revenue | $394,185 | $378,143 | $1,091,352 | $1,127,646 |
| EXPENSES: | ||||
| Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) | 51,591 | 63,099 | 150,248 | 183,215 |
| External R&D expenses: | ||||
| Development programs: | ||||
| Alixorexton | 25,812 | 11,873 | 67,461 | 34,918 |
| LYBALVI | 4,759 | 5,549 | 13,661 | 14,296 |
| Other external R&D expenses | 12,648 | 8,552 | 34,210 | 27,358 |
| Total external R&D expenses | 43,219 | 25,974 | 115,332 | 76,572 |
| Internal R&D expenses: | ||||
| Employee-related | 30,862 | 26,844 | 92,867 | 87,624 |
| Occupancy | 3,241 | 2,768 | 9,696 | 8,538 |
| Depreciation | 1,405 | 1,440 | 4,346 | 4,243 |
| Other internal R&D expenses | 3,012 | 2,866 | 8,685 | 10,175 |
| Total internal R&D expenses | 38,520 | 33,918 | 115,594 | 110,580 |
| R&D expenses | 81,739 | 59,892 | 230,926 | 187,152 |
| Selling, general and administrative expenses: | ||||
| Selling and marketing expense | 115,630 | 102,043 | 359,740 | 347,327 |
| General and administrative expense | 56,143 | 48,339 | 154,586 | 150,917 |
| Total selling, general and administrative expense | 171,773 | 150,382 | 514,326 | 498,244 |
| Other segment income (expenses)(1) | (6,321) | (11,975) | (3,529) | (32,634) |
| NET INCOME FROM CONTINUING OPERATIONS | 82,761 | 92,795 | 192,323 | 226,401 |
| LOSS ON DISCONTINUED OPERATIONS, NET OF TAX | — | (414) | — | (5,834) |
| NET INCOME | $82,761 | $92,381 | $192,323 | $220,567 |
“Other segment income (expenses)” during the three and nine months ended September 30, 2025 and 2024, includes “Amortization of acquired intangible assets”, “Other income, net” and “Income tax provision”.
- COMMITMENTS AND CONTINGENT LIABILITIES
Litigation
From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, the Company would accrue a liability for the estimated loss. Because of uncertainties related to claims and litigation, accruals are based on the Company’s best estimates, utilizing all available information. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation or settlement of claims, the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in material adverse adjustments to the Company’s operating results. At September 30, 2025, there wereno potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were probable of occurring. For claims that are reasonably possible, no estimable loss or range of loss can be made.
INVEGA TRINZA ANDA Litigation
In September 2020, Janssen Pharmaceutica, Janssen Pharmaceuticals, Inc., and Janssen Research & Development, LLC initiated a patent infringement lawsuit in the U.S. District Court for the District of New Jersey (the “NJ District Court”) against Mylan Laboratories Limited (“Mylan Labs”) and other Mylan entities following the filing by Mylan Labs of an abbreviated new drug application (“ANDA”) seeking approval from the U.S. Food and Drug Administration (“FDA”) to market a generic version of INVEGA TRINZA before the expiration of U.S. Patent No. 10,143,693 (the “’693 Patent”). Requested judicial remedies include recovery of litigation costs and injunctive relief. In May 2023, the NJ District Court issued an opinion in favor of the Janssen entities on the issues of infringement and validity of the ’693 Patent and the Mylan entities filed a notice of appeal of the decision. In March 2025, the U.S. Court of Appeals for the Federal Circuit (the “Federal Circuit Court”) issued a decision affirming the NJ District Court opinion and in May 2025, Mylan Labs filed a petition for panel rehearing or rehearing en banc, which was denied on July 1, 2025. The Company is not a party to this proceeding.
VUMERITY ANDA Litigation
In July 2023, Biogen Inc., Biogen Swiss Manufacturing GmbH and Alkermes Pharma Ireland Limited (“APIL”), a wholly-owned subsidiary of the Company, filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware (the “DE District Court”) against Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Limited (collectively, “Zydus”) following the filing by Zydus of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VUMERITY (diroximel fumarate) delayed-release capsules for oral use, 231 mg, before expiration of the Company’s U.S. Patent Nos. 8,669,281; 9,090,558; and 10,080,733 (the “VUMERITY patents”). The filing of the lawsuit triggered a stay of FDA approval of the ANDA for up to 30 months in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”). On July 21, 2025, the parties entered into a confidential settlement agreement, pursuant to which Zydus was granted a license under the VUMERITY patents to engage in the commercial manufacture, use or sale of a generic version of VUMERITY in the United States beginning on an agreed date immediately prior to expiration of the latest to expire of the VUMERITY patents, or earlier under certain customary circumstances. In connection with the settlement agreement, the DE District Court dismissed the litigation pursuant to the parties’ stipulation of dismissal.
LYBALVI ANDA Litigation
On August 15, 2025, August 27, 2025 and September 5, 2025, APIL and Alkermes, Inc., two wholly-owned subsidiaries of the Company, filed a patent infringement lawsuit in the NJ District Court against each of Teva, Apotex, and MSN (each as defined herein), respectively, and on August 28, 2025, APIL and Alkermes, Inc. filed a patent infringement lawsuit in the DE District Court against Apotex. As used herein, Teva refers to Teva Pharmaceuticals, Inc., Apotex refers to Apotex Inc. and Apotex Corp., and MSN refers to MSN Laboratories Private Limited (“MSN Labs”), MSN Pharmaceuticals, Inc. and Novadoz Pharmaceuticals LLC. These lawsuits were filed following receipt of a “paragraph IV certification” notice from each of Teva, Apotex and MSN Labs regarding their respective filings of an ANDA with the FDA seeking approval to engage in the commercial manufacture, use or sale of a generic version of LYBALVI (olanzapine and samidorphan tablets, 5mg/10mg, 10mg/10mg, 15mg/10mg and 20mg/10mg) in the U.S. prior to the expiration of certain of the Company’s U.S. patents. The notices alleged that certain of the Company’s patents related to LYBALVI, with expiration dates between 2032 and 2041, are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the proposed generic products. The Company intends to vigorously defend its intellectual property. The filing of each lawsuit within 45 days of receipt of each of the respective notices triggered stays of FDA approval of each of the respective ANDAs for up to 30 months in accordance with the Hatch-Waxman Act. On August 20, 2025, APIL and Alkermes, Inc. amended the complaint in the lawsuit against Teva to include an additional patent.
Antitrust Class Action Litigation
On October 2, 2025, Value Drug Company filed a complaint asserting antitrust claims against Alkermes, Inc. and APIL in the U.S. District Court for the District of Massachusetts. The complaint was filed on behalf of a putative class of direct purchasers of VIVITROL and alleges that the Company’s U.S. Patent No. 7,919,499 related to VIVITROL was fraudulently obtained, improperly listed in the Orange Book, and wrongfully enforced, resulting in delayed market entry for generic forms of VIVITROL. The lawsuit seeks, among other things, unspecified money damages plus interest, reasonable attorneys’ fees and other costs. The Company intends to vigorously defend itself in this matter.
Government Matters
The Company has received a subpoena and civil investigative demands from U.S. state and federal governmental authorities. The Company is cooperating with the investigations.
Product Liability and Other Legal Proceedings
The Company is involved in litigation and other legal proceedings incidental to its normal business activities, including a product liability case alleging that the FDA-approved VIVITROL labeling was inadequate and that VIVITROL caused the individual to suffer from opioid overdose and death. The Company intends to vigorously defend itself in these matters.
In addition, in January 2023, Acorda Therapeutics, Inc. (“Acorda”) filed a petition with the U.S. District Court for the Southern District of New York (the “NY Southern District Court”) asking the court to confirm in part and modify in part the final arbitral award rendered by an arbitration panel in October 2022 and, as part of the requested modification, seeking an additional approximately $66.0 million in damages. In August 2023, the NY Southern District Court confirmed the final arbitral award and declined to modify the final award to increase the damages awarded thereunder. In September 2023, Acorda filed a notice of appeal of the NY Southern District Court decision to the Federal Circuit Court. On July 25, 2025, the Federal Circuit Court transferred the appeal due to lack of jurisdiction to the U.S. Court of Appeals for the Second Circuit.
Guarantees
In connection with the Separation, the Company entered into an assignment and assumption of lease agreement (the “Assignment”) pursuant to which Alkermes, Inc., a wholly owned subsidiary of the Company, assigned to Mural Oncology, Inc. (“Mural US”), a subsidiary of Mural, an operating lease for approximately 180,000 square feet of corporate office space, administrative areas and laboratories located at 852 Winter Street in Waltham, Massachusetts (the “852 Winter Street Lease”), as described in more detail in Note 10, Leasesin the “Notes to Consolidated Financial Statements” in the Annual Report. Although all of the rights, title and interest in, to and under the 852 Winter Street Lease were transferred to Mural US as of November 15, 2023 pursuant to the Assignment, the Company ratified and reaffirmed for the remainder of the lease term its guarantor obligations in respect of the lease under that certain Guaranty dated as of May 16, 2014. This lease expires in 2026 and we do not expect its term to be extended. Upon completion of the Separation, the Assignment was accounted for as a termination of the original lease and the Company de-recognized the right-of-use asset and lease liability related to the 852 Winter Street Lease. At September 30, 2025, the fair value of the guarantee wasnot material to the Company.
- SUBSEQUENT EVENT
On October 22, 2025 (the “Agreement Date”), the Company and Avadel Pharmaceuticals plc (“Avadel”) entered into a definitive transaction agreement (the “Transaction Agreement”), pursuant to which the Company has agreed to acquire the entire issued and to be issued ordinary share capital of Avadel (such proposed offer, the “Proposed Acquisition”), for $18.50 per ordinary share, nominal value $0.01 per share, of Avadel (each, an “Avadel Share”), payable in cash at closing (the “Cash Consideration”). In addition, the Company agreed to provide Avadel shareholders with a non-transferable contingent value right entitling holders to a potential additional cash payment of $1.50 per Avadel Share, contingent upon achievement of certain specified milestones, for a total potential consideration of $20.00 per Avadel Share. The Proposed Acquisition was recommended by the boards of directors of both Alkermes and Avadel and is expected to be effected by means of a court-sanctioned scheme of arrangement (the “Scheme”) under Irish law. The completion of the Proposed Acquisition is subject to customary conditions, including, among other things, approval by Avadel’s shareholders, the sanction of the Scheme by the Irish High Court, and the receipt of required antitrust clearances in the United States. The conditions to the completion of the Proposed Acquisition are set out in full in Appendix III to the announcement related to the Proposed Acquisition issued by the Company and Avadel pursuant to Rule 2.7 of the Irish Takeover Panel Act 1997, Takeover Rules, 2022 (the “Conditions Appendix”).
The Transaction Agreement contains customary representations and warranties and customary covenants with respect to Alkermes and Avadel. The Transaction Agreement contains customary termination rights and may be abandoned at any time prior to the Effective Time (as defined in the Transaction Agreement) by mutual written consent of Alkermes and Avadel, subject to the consent of the Irish Takeover Panel. Avadel also has the right, prior to the receipt of the requisite Avadel shareholder approvals, to terminate the Transaction Agreement to accept a Company Superior Proposal (as defined in the Transaction Agreement) in certain circumstances, and Alkermes also has the right, prior to receipt of the requisite Avadel shareholder approvals, to terminate the Transaction Agreement if a Company Board Change of Recommendation (as defined in the Transaction Agreement) occurs. Subject to the satisfaction or waiver of all applicable closing conditions, the Company currently expects the Proposed Acquisition to be completed in the first quarter of 2026.
In connection with the Proposed Acquisition, on the Agreement Date, the Company, as the TopCo Borrower, together with Alkermes, Inc., as the U.S. Borrower, entered into a bridge term loan credit agreement with JPMorgan Chase Bank, N.A., as Administrative Agent, Sole Lead Arranger and Sole Bookrunner, and the lenders party thereto (the “Bridge Credit Agreement”), which provides for a senior secured bridge term loan facility (the “Bridge Credit Facility”) in an aggregate principal amount of up to approximately $1.2 billion that is available to finance the payment of the Cash Consideration and fees and expenses related to the Proposed Acquisition. In addition, the Company placed approximately $700.0 million of its cash into an escrow account to finance the remainder of the consideration for the Proposed Acquisition. Loans under the Bridge Credit Facility will be available after the Agreement Date, subject to the satisfaction of certain conditions set forth in the Bridge Credit Agreement, and will mature on the date that is 364 days after the date on which the loans are funded under the Bridge Credit Facility. The commitments under the Bridge Credit Facility, unless previously terminated, terminate on the earlier of (i) the date on which all of the consideration payable in respect of the Proposed Acquisition has been paid in full without the making of any loans under the Bridge Credit Facility and (ii) the date on which a Mandatory Cancellation Event (as defined in the Bridge Credit Agreement) occurs or exists.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.