Over the last four quarters, the company has surpassed consensus EPS estimates two times. Alkermes, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $390.66 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 15.38%. This compares to year-ago revenues of $399.13 million. The company has topped consensus revenue estimates two times over the last four quarters. This quarterly report represents an earnings surprise of +26.83%. A quarter a ...

PART I - FINANCIAL INFORMATION This part presents the unaudited condensed consolidated financial statements, management's discussion, market risk disclosures, and internal controls [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of income and comprehensive income, cash flows, and shareholders' equity, along with detailed notes explaining significant accounting policies, revenue recognition, investments, and commitments [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%E2%80%94%20June%2030%2C%202025%20and%20December%2031%2C%202024) This section summarizes the company's financial position, including assets, liabilities, and shareholders' equity at specific dates **Condensed Consolidated Balance Sheet Highlights (in thousands):** | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Total Assets | $2,252,809 | $2,055,567 | | Cash and cash equivalents | $521,199 | $291,146 | | Total Liabilities | $628,225 | $590,590 | | Total Shareholders' Equity | $1,624,584 | $1,464,977 | [Condensed Consolidated Statements of Income and Comprehensive Income](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Income%20and%20Comprehensive%20Income%20%E2%80%94%20For%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section details financial performance, including revenues, operating income, net income, and earnings per share over specified periods **Condensed Consolidated Statements of Income and Comprehensive Income Highlights (in thousands, except per share amounts):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $390,657 | $399,131 | $697,167 | $749,503 | | Operating income from continuing operations | $92,978 | $109,883 | $106,770 | $153,192 | | Net income | $87,098 | $91,358 | $109,562 | $128,186 | | Earnings per ordinary share - diluted | $0.52 | $0.53 | $0.65 | $0.75 | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%E2%80%94%20For%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section outlines cash inflows and outflows from operating, investing, and financing activities over specified periods **Condensed Consolidated Statements of Cash Flows Highlights (in thousands):** | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash flows provided by operating activities | $249,013 | $167,138 | | Cash flows (used in) provided by investing activities | $(20,112) | $11,899 | | Cash flows provided by (used in) financing activities | $1,152 | $(101,356) | | Net increase in cash and cash equivalents | $230,053 | $77,681 | | Cash and cash equivalents—End of period | $521,199 | $535,150 | [Condensed Consolidated Statements of Shareholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity%20%E2%80%94%20For%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section presents changes in shareholders' equity, including ordinary shares, additional paid-in capital, and accumulated deficit **Shareholders' Equity Changes (in thousands, except share data):** | Metric | December 31, 2024 | June 30, 2025 | | :------------------------------------ | :------------------ | :------------------ | | Ordinary Shares (issued) | 176,670,785 | 180,439,750 | | Ordinary Shares (amount) | $1,767 | $1,805 | | Additional Paid-In Capital | $2,860,890 | $2,940,789 | | Accumulated Deficit | $(976,458) | $(866,896) | | Total Shareholders' Equity | $1,464,977 | $1,624,584 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [Note 1. The Company](index=11&type=section&id=1.%20THE%20COMPANY) Alkermes plc is a global biopharmaceutical company focused on neuroscience, with a portfolio of commercial products for alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder, and a pipeline in neurological disorders. The company completed the sale of its Athlone Facility to Novo Nordisk in May 2024, receiving approximately $97.9 million and recording a $1.5 million gain - Alkermes plc is a global biopharmaceutical company specializing in neuroscience, with commercial products for alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder, and a pipeline for neurological disorders[25](index=25&type=chunk) - Completed the sale of its Athlone Facility to Novo Nordisk in May 2024, receiving approximately **$97.9 million** and recording a gain of approximately **$1.5 million**[26](index=26&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) The unaudited condensed consolidated financial statements are prepared consistently with audited annual statements, with the oncology business classified as discontinued operations. The company operates as a single segment and is evaluating the impact of new accounting pronouncements on income tax disclosures and expense disaggregation - The oncology business (Mural Oncology plc) was classified as discontinued operations following its separation in November 2023[30](index=30&type=chunk) - The company is managed as a single operating segment, focusing on developing, manufacturing, and commercializing medicines for psychiatric and neurological disorders[32](index=32&type=chunk) - Evaluating the impact of new ASUs: ASU 2023-09 (Income Tax Disclosures, effective after Dec 15, 2024) and ASU 2024-03 (Expense Disaggregation Disclosures, effective after Dec 15, 2026)[34](index=34&type=chunk)[35](index=35&type=chunk) [Note 3. Discontinued Operations](index=13&type=section&id=3.%20DISCONTINUED%20OPERATIONS) The company's former oncology business, separated into Mural Oncology plc, is classified as discontinued operations. No losses from discontinued operations were recorded for the three and six months ended June 30, 2025, compared to losses in the prior year - No losses from discontinued operations were recorded for the three and six months ended June 30, 2025[37](index=37&type=chunk) **Loss from Discontinued Operations (in thousands):** | Metric | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :----------------------------- | | Net loss and comprehensive loss from discontinued operations | $(3,300) | $(5,420) | [Note 4. Revenue from Contracts with Customers](index=13&type=section&id=4.%20REVENUE%20FROM%20CONTRACTS%20WITH%20CUSTOMERS) Product sales, net, increased for VIVITROL, ARISTADA/ARISTADA INITIO, and LYBALVI. Manufacturing and royalty revenues decreased, primarily due to the expiration of the INVEGA SUSTENNA U.S. royalty. Medicaid rebates were lower than estimated, leading to reserve reductions **Product Sales, Net (in thousands):** | Product | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | VIVITROL | $121,660 | $111,873 | $222,656 | $209,532 | | ARISTADA and ARISTADA INITIO | $101,295 | $86,049 | $174,770 | $164,919 | | LYBALVI | $84,280 | $71,351 | $154,302 | $128,358 | | **Total product sales, net** | **$307,235** | **$269,273** | **$551,728** | **$502,809** | - Actual Medicaid rebates for VIVITROL and ARISTADA/ARISTADA INITIO were lower than original estimates, resulting in a reduction of rebate reserves by approximately **$17.7 million** and **$7.2 million**, respectively, during the six months ended June 30, 2025[41](index=41&type=chunk) **Manufacturing and Royalty Revenues (in thousands):** | Product | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Long-acting INVEGA products | $30,315 | $78,739 | $48,060 | $141,412 | | VUMERITY | $39,399 | $35,234 | $67,232 | $66,488 | | RISPERDAL CONSTA | $3,820 | $3,558 | $12,949 | $6,276 | | Other | $9,888 | $12,327 | $17,198 | $32,515 | | **Total** | **$83,422** | **$129,858** | **$145,439** | **$246,691** | - Royalty on U.S. net sales of INVEGA SUSTENNA expired in August 2024, leading to an expected continued decrease in royalty revenues from long-acting INVEGA products in 2025[44](index=44&type=chunk) [Note 5. Investments](index=16&type=section&id=5.%20INVESTMENTS) The company's investment portfolio, primarily in U.S. government/agency and corporate debt securities, totaled $532.8 million at June 30, 2025. A new commitment of up to €10.0 million was made to Fountain Healthcare Partners Fund IV, L.P. in February 2025 **Total Investments (in thousands):** | Metric | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Total investments | $532,809 | $533,670 | - In February 2025, the company committed up to **€10.0 million** to Fountain Healthcare Partners Fund IV, L.P., an investment partnership in the healthcare, pharmaceutical, and life sciences sectors, accounted for under the equity method[49](index=49&type=chunk) [Note 6. Fair Value](index=17&type=section&id=6.%20FAIR%20VALUE) The company's assets measured at fair value, including cash equivalents and debt securities, totaled $550.4 million at June 30, 2025. No transfers between fair value hierarchy levels occurred during the six months ended June 30, 2025 **Total Assets Measured at Fair Value (in thousands):** | Metric | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Total | $550,404 | $541,913 | - No transfers of securities between fair value hierarchy levels occurred during the six months ended June 30, 2025[50](index=50&type=chunk) [Note 7. Inventory](index=18&type=section&id=7.%20INVENTORY) Total inventory increased to $191.9 million at June 30, 2025, from $182.9 million at December 31, 2024, primarily driven by an increase in finished goods **Inventory (in thousands):** | Metric | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Raw materials | $68,423 | $72,139 | | Work in process | $81,390 | $79,871 | | Finished goods | $42,111 | $30,877 | | **Total inventory** | **$191,924** | **$182,887** | [Note 8. Property, Plant and Equipment](index=18&type=section&id=8.%20PROPERTY%2C%20PLANT%20AND%20EQUIPMENT) Net property, plant, and equipment increased to $239.4 million at June 30, 2025, from $227.6 million at December 31, 2024, despite a decrease in construction in progress **Property, Plant and Equipment, Net (in thousands):** | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Total property, plant and equipment, net | $239,399 | $227,564 | | Construction in progress | $37,043 | $58,391 | [Note 9. Leases](index=19&type=section&id=9.%20LEASES) Total operating lease liabilities were $72.7 million at June 30, 2025, with a weighted average remaining lease term of 6.5 years. Operating lease expense for the six months ended June 30, 2025, was $3.7 million **Operating Lease Information (in thousands):** | Metric | June 30, 2025 | | :------------------------------------ | :------------ | | Total operating lease liabilities | $72,678 | | Weighted average remaining lease term | 6.5 years | | Weighted average incremental borrowing rate | 3.8% | | Operating lease expense (Six Months Ended June 30, 2025) | $3,700 | | Operating lease expense (Six Months Ended June 30, 2024) | $3,600 | [Note 10. Accounts Payable and Accrued Expenses](index=19&type=section&id=10.%20ACCOUNTS%20PAYABLE%20AND%20ACCRUED%20EXPENSES) Total accounts payable and accrued expenses increased to $245.7 million at June 30, 2025, from $185.3 million at December 31, 2024, primarily due to a significant rise in accounts payable. Accrued sales discounts, allowances, and reserves decreased **Accounts Payable and Accrued Expenses (in thousands):** | Metric | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Accounts payable | $99,206 | $45,630 | | Accrued compensation | $56,544 | $70,960 | | Accrued other | $89,999 | $68,742 | | **Total accounts payable and accrued expenses** | **$245,749** | **$185,332** | | Accrued sales discounts, allowances and reserves | $253,173 | $272,452 | [Note 11. Shareholders' Equity](index=19&type=section&id=11.%20SHAREHOLDERS'%20EQUITY) The company's board approved a $400.0 million share repurchase program in February 2024. No ordinary shares were repurchased under this program during the six months ended June 30, 2025, leaving $200.0 million authorized - A **$400.0 million** share repurchase program was approved in February 2024[57](index=57&type=chunk) - No ordinary shares were repurchased under the program during the six months ended June 30, 2025[57](index=57&type=chunk) - As of June 30, 2025, **$200.0 million** remained authorized under the Repurchase Program[57](index=57&type=chunk) [Note 12. Share-Based Compensation](index=20&type=section&id=12.%20SHARE-BASED%20COMPENSATION) Total share-based compensation expense for the three months ended June 30, 2025, increased to $25.0 million, while for the six months, it decreased to $47.8 million **Share-Based Compensation Expense (in thousands):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total share-based compensation expense | $24,966 | $20,601 | $47,776 | $53,356 | [Note 13. Earnings Per Ordinary Share](index=20&type=section&id=13.%20EARNINGS%20PER%20ORDINARY%20SHARE) Diluted EPS from continuing operations decreased to $0.52 for the three months and $0.65 for the six months ended June 30, 2025, compared to the prior year periods **Earnings Per Ordinary Share (Diluted):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Earnings per ordinary share from continuing operations - diluted | $0.52 | $0.55 | $0.65 | $0.78 | | Earnings per ordinary share - diluted | $0.52 | $0.53 | $0.65 | $0.75 | [Note 14. Income Taxes](index=21&type=section&id=14.%20INCOME%20TAXES) Income tax provisions decreased for both the three and six months ended June 30, 2025, primarily due to taxes on Irish income. The effective tax rate decreased to 15.9% for the six months ended June 30, 2025, influenced by windfall benefits from employee equity activity and a 2024 expense related to the Athlone Facility sale. The recently signed OBB Bill is expected to materially impact future cash flows and deferred tax assets **Income Tax Provision (in millions):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Income tax provision | $17.7 | $22.1 | $20.8 | $30.0 | - The effective tax rate for the six months ended June 30, 2025, was **15.9%**, down from **18.3%** in the prior year, primarily due to increased windfall benefits from employee equity activity and a 2024 expense related to the Athlone Facility sale[63](index=63&type=chunk) - The One Big Beautiful Bill (OBB Bill), signed July 4, 2025, is expected to materially increase cash flows from operating activities and decrease net U.S. deferred tax assets over the next few years[64](index=64&type=chunk) [Note 15. Segment Reporting](index=21&type=section&id=15.%20SEGMENT%20REPORTING) The company operates as a single segment, with the CODM reviewing R&D, selling and marketing, and general and administrative expenses. Total revenue and selling, general and administrative expenses decreased for the six months ended June 30, 2025, while R&D expenses increased - The company is managed as one segment, with the CODM reviewing R&D, selling and marketing, and general and administrative expenses[32](index=32&type=chunk)[65](index=65&type=chunk) **Key Segment Expenses (in thousands):** | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Total revenue | $697,167 | $749,503 | | R&D expenses | $149,187 | $127,260 | | Selling, general and administrative expense | $342,553 | $347,862 | [Note 16. Commitments and Contingent Liabilities](index=22&type=section&id=16.%20COMMITMENTS%20AND%20CONTINGENT%20LIABILITIES) The company is involved in various legal proceedings, including patent infringement lawsuits for INVEGA TRINZA and VUMERITY, government investigations related to VIVITROL, and product liability claims. The VUMERITY ANDA litigation was settled in July 2025, granting a license for a generic version. The company also maintains guarantor obligations for a lease transferred to Mural US - The U.S. Court of Appeals for the Federal Circuit affirmed the NJ District Court's opinion in favor of Janssen regarding the '693 Patent for INVEGA TRINZA in March 2025; Mylan Labs filed for rehearing in May 2025[69](index=69&type=chunk) - The VUMERITY ANDA litigation was settled in July 2025, granting Zydus a license to commercialize a generic version of VUMERITY prior to patent expiration, leading to the dismissal of the litigation[70](index=70&type=chunk) - The company is cooperating with U.S. state and federal governmental authorities regarding subpoenas and civil investigative demands for documents related to VIVITROL[71](index=71&type=chunk) - The company ratified guarantor obligations for the 852 Winter Street Lease, which was assigned to Mural Oncology, Inc. post-Separation; the fair value of this guarantee is not material[74](index=74&type=chunk)[75](index=75&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an executive summary of financial performance, detailed analysis of product sales, manufacturing and royalty revenues, operating expenses, and liquidity. It highlights a decrease in net income from continuing operations primarily due to lower manufacturing and royalty revenues, partially offset by increased product sales. R&D expenses increased, while SG&A expenses showed mixed trends [Executive Summary](index=25&type=section&id=Executive%20Summary) This section provides an overview of financial performance, highlighting key changes in net income, product sales, and revenues **Net Income from Continuing Operations (in millions, except per share amounts):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net income from continuing operations | $87.1 | $94.7 | $109.6 | $133.6 | | Diluted EPS from continuing operations | $0.52 | $0.55 | $0.65 | $0.78 | - Decreases in net income from continuing operations were primarily due to lower manufacturing and royalty revenues, partially offset by increases in product sales[79](index=79&type=chunk) [Products](index=25&type=section&id=Products) This section details proprietary marketed products, licensed products, and key development programs, including recent patent grants and clinical trial results [Marketed Products](index=25&type=section&id=Marketed%20Products) This section describes the company's proprietary marketed products for schizophrenia, bipolar I disorder, and alcohol/opioid dependence - Proprietary products include ARISTADA and ARISTADA INITIO for schizophrenia, LYBALVI for schizophrenia and bipolar I disorder, and VIVITROL for alcohol and opioid dependence[82](index=82&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk) - U.S. Patent No. 12,311,027 relating to ARISTADA was granted in May 2025, with claims to pharmaceutical compositions for long-term stability and methods of treating schizophrenia, expiring in 2033[86](index=86&type=chunk) [Products Using Our Proprietary Technologies and Licensed Product](index=28&type=section&id=Products%20Using%20Our%20Proprietary%20Technologies%20and%20Licensed%20Product) This section details products utilizing licensed technologies, including long-acting INVEGA products and VUMERITY - Long-acting INVEGA products (INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA, INVEGA HAFYERA/BYANNLI) are owned and commercialized worldwide by Janssen, incorporating Alkermes' technologies[92](index=92&type=chunk) - The company's royalty on U.S. net sales of INVEGA SUSTENNA expired in August 2024, which is expected to lower future royalty revenues from long-acting INVEGA products[44](index=44&type=chunk)[106](index=106&type=chunk) - VUMERITY, licensed to Biogen for multiple sclerosis, had its ANDA litigation settled in July 2025, granting Zydus a license for a generic version[97](index=97&type=chunk)[98](index=98&type=chunk)[70](index=70&type=chunk) [Key Development Program](index=29&type=section&id=Key%20Development%20Program) This section highlights the Alixorexton development program for narcolepsy and idiopathic hypersomnia, including Phase 2 results - Alixorexton (ALKS 2680) is a novel, investigational, oral, selective orexin 2 receptor agonist in development for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia[100](index=100&type=chunk) - In July 2025, alixorexton achieved the primary endpoint in the Phase 2 Vibrance-1 study in patients with narcolepsy type 1, and the company plans to initiate a Phase 3 program in narcolepsy[100](index=100&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) This section analyzes financial results, focusing on product sales, manufacturing and royalty revenues, and various operating expenses [Product Sales, Net](index=30&type=section&id=Product%20Sales%2C%20Net) Product sales, net, increased by $38.0 million to $307.2 million for the three months and by $49.0 million to $551.7 million for the six months ended June 30, 2025. This growth was driven by increased LYBALVI and ARISTADA/ARISTADA INITIO unit sales and a 3% price increase for proprietary products, partially offset by a decrease in VIVITROL unit sales. Medicaid rebates as a percentage of sales decreased due to lower actual rebates **Product Sales, Net (in millions):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Product sales, net | $307.2 | $269.3 | $551.7 | $502.8 | | Change YoY | +$38.0 | - | +$49.0 | - | - The increase in product sales, gross, for the three months ended June 30, 2025, was due to a **14% increase** in LYBALVI units sold, a **2% increase** in ARISTADA/ARISTADA INITIO units sold, and a **3% price increase** for proprietary products, partially offset by a **1% decrease** in VIVITROL units sold[102](index=102&type=chunk) - Medicaid rebates as a percentage of sales decreased for both the three and six months ended June 30, 2025, primarily due to actual rebates for VIVITROL and ARISTADA/ARISTADA INITIO being lower than original estimates[104](index=104&type=chunk) [Manufacturing and Royalty Revenues](index=31&type=section&id=Manufacturing%20and%20Royalty%20Revenues) Manufacturing and royalty revenues decreased by $46.5 million to $83.4 million for the three months and by $101.3 million to $145.4 million for the six months ended June 30, 2025. This decline was primarily due to the expiration of the INVEGA SUSTENNA U.S. royalty. VUMERITY revenue increased due to higher royalties, while RISPERDAL CONSTA revenue rose from increased manufacturing. Other revenues decreased as FAMPYRA manufacturing obligations concluded **Manufacturing and Royalty Revenues (in millions):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Manufacturing and royalty revenues | $83.4 | $129.9 | $145.4 | $246.7 | | Change YoY | $(46.5) | - | $(101.3) | - | - The primary driver for the decrease in royalty revenues from long-acting INVEGA products was the expiration of the royalty on net sales of INVEGA SUSTENNA in the U.S. in August 2024[106](index=106&type=chunk) - VUMERITY revenue increased due to higher royalty revenue from end-market sales, partially offset by decreases in manufacturing revenue. RISPERDAL CONSTA revenue increased due to higher manufacturing revenue from increased U.S. batches[106](index=106&type=chunk) [Costs and Expenses](index=31&type=section&id=Costs%20and%20Expenses) This section provides a detailed breakdown and analysis of cost of goods, research and development, and selling, general and administrative expenses [Cost of Goods Manufactured and Sold](index=31&type=section&id=Cost%20of%20Goods%20Manufactured%20and%20Sold) Cost of goods manufactured and sold decreased by $12.0 million to $49.5 million for the three months and by $21.4 million to $98.7 million for the six months ended June 30, 2025. This reduction was mainly due to lower costs for legacy products after the Athlone Facility sale and decreased VIVITROL unit sales, partially offset by increased LYBALVI unit sales **Cost of Goods Manufactured and Sold (in millions):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Cost of goods manufactured and sold | $49.5 | $61.5 | $98.7 | $120.1 | | Change YoY | $(12.0) | - | $(21.4) | - | - Decreases were primarily related to lower costs for certain legacy products following the sale of the Athlone Facility in May 2024 and decreased VIVITROL unit sales[107](index=107&type=chunk) - These decreases were partially offset by increases in the cost of goods sold for LYBALVI due to increases in the number of units sold[107](index=107&type=chunk) [Research and Development Expenses](index=32&type=section&id=Research%20and%20Development%20Expenses) Total R&D expenses increased by $17.8 million to $77.4 million for the three months and by $21.9 million to $149.2 million for the six months ended June 30, 2025. This rise was mainly driven by increased spending on the Alixorexton development program, including new clinical studies, and higher employee-related expenses due to a 10% increase in R&D headcount **Research and Development Expenses (in millions):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expenses | $77.4 | $59.6 | $149.2 | $127.3 | | Change YoY | +$17.8 | - | +$21.9 | - | - Expenses related to Alixorexton increased due to advancement of the development program, including the initiation of the Vibrance-3 phase 2 clinical study and costs for the long-term extension study[110](index=110&type=chunk) - Employee-related R&D expenses increased due to a **10% increase** in R&D-related headcount[110](index=110&type=chunk) [Selling, General and Administrative Expense](index=33&type=section&id=Selling%2C%20General%20and%20Administrative%20Expense) Total SG&A expense increased by $2.7 million to $170.8 million for the three months but decreased by $5.3 million to $342.6 million for the six months ended June 30, 2025. The three-month increase was due to higher employee-related expenses from a 13% increase in sales and marketing headcount, partially offset by reduced marketing spend. The six-month decrease was driven by lower marketing spend, professional service fees, and branded prescription drug fees **Selling, General and Administrative Expense (in millions):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Selling, general and administrative expense | $170.8 | $168.1 | $342.6 | $347.9 | | Change YoY | +$2.7 | - | $(5.3) | - | - Selling and marketing expense for the three months increased due to a **$10.4 million** rise in employee-related expenses (**13% headcount increase**), offset by an **$8.9 million** decrease in marketing spend[111](index=111&type=chunk) - General and administrative expense for the six months decreased due to lower branded prescription drug fees, professional service fees, and share-based compensation expense[114](index=114&type=chunk) [Other Income, Net](index=33&type=section&id=Other%20Income%2C%20Net) This section details the significant increase in other income, net, primarily due to the elimination of interest expense **Total Other Income, Net (in millions):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total other income, net | $11.9 | $6.8 | $23.6 | $10.4 | | Change YoY | +$5.1 | - | +$13.2 | - | - Interest expense decreased to zero in 2025 due to the full prepayment and termination of former term loans in December 2024[115](index=115&type=chunk) [Income Tax Provision](index=33&type=section&id=Income%20Tax%20Provision) This section analyzes the income tax provision, highlighting changes due to Irish income taxes and effective tax rate adjustments **Income Tax Provision (in millions):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Income tax provision | $17.7 | $22.1 | $20.8 | $30.0 | | Change YoY | $(4.4) | - | $(9.2) | - | [Liquidity and Financial Condition](index=34&type=section&id=Liquidity%20and%20Financial%20Condition) This section assesses the company's liquidity, cash flows, and financial position, including cash and investment levels **Total Cash and Investments (in millions):** | Metric | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Total cash and investments | $1,054.0 | $824.7 | **Cash Flow Summary (in millions):** | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Cash flows provided by operating activities | $249.0 | $167.1 | | Cash flows (used in) provided by investing activities | $(20.1) | $12.0 | | Cash flows provided by (used in) financing activities | $1.2 | $(101.4) | - The company expects its existing cash, cash equivalents, and investments to be sufficient to finance anticipated working capital and other cash requirements for at least twelve months[118](index=118&type=chunk) [Critical Accounting Estimates](index=35&type=section&id=Critical%20Accounting%20Estimates) This section refers to the Annual Report on Form 10-K for a discussion of critical accounting estimates - Refers to the 'Critical Accounting Estimates' section in the Annual Report on Form 10-K for a discussion of critical accounting estimates[129](index=129&type=chunk) [New Accounting Standards](index=36&type=section&id=New%20Accounting%20Standards) This section refers to Note 2, Summary of Significant Accounting Policies, for a discussion of recent accounting standards applicable to the company - Refers to the 'New Accounting Pronouncements' section in Note 2 for discussion of certain recent accounting standards applicable to the company[130](index=130&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's market risks, including investment portfolio and non-U.S. currency exchange risks, have not materially changed since December 31, 2024, and no near-term changes in exposures or management strategies are anticipated - No material changes to market risks (investment portfolio and non-U.S. currency exchange risk) since December 31, 2024[131](index=131&type=chunk)[132](index=132&type=chunk) - No near-term changes are anticipated in market risk exposures or management's objectives and strategies for managing such exposures[131](index=131&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, providing reasonable assurance. There have been no material changes in internal control over financial reporting during the three months ended June 30, 2025 [Evaluation of Disclosure Controls and Procedures](index=36&type=section&id=a)%20Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures as of June 30, 2025 - Management concluded that disclosure controls and procedures were effective as of June 30, 2025, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[133](index=133&type=chunk) [Change in Internal Control Over Financial Reporting](index=36&type=section&id=b)%20Change%20in%20Internal%20Control%20Over%20Financial%20Reporting) This section reports no material changes in internal control over financial reporting during the quarter - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[134](index=134&type=chunk) PART II - OTHER INFORMATION This part covers legal proceedings, risk factors, unregistered equity sales, and a list of exhibits [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the discussion of legal proceedings from Note 16, Commitments and Contingent Liabilities, in the Notes to Condensed Consolidated Financial Statements - Refers to Note 16, Commitments and Contingent Liabilities, for information regarding legal proceedings[136](index=136&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section introduces a new risk factor concerning the adverse effects of changes in global trade or other policies - Changes in global trade or other policies, including tariffs or other restrictions, could have an adverse effect on the company's business, results of operations, or financial condition[138](index=138&type=chunk) - Potential impacts include increased costs for internationally sourced materials, uncertainty regarding pharmaceutical imports, and volatility in the market price of ordinary shares[138](index=138&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the three months ended June 30, 2025, the company purchased 56,457 ordinary shares at an average price of $29.72 to satisfy tax withholding obligations related to equity awards. No shares were repurchased under the $400.0 million Repurchase Program, leaving $200.0 million authorized **Ordinary Shares Purchased (Q2 2025):** | Period | Total Number of Ordinary Shares Purchased | Average Price Paid per Ordinary Share | | :-------------------------- | :------------------------------------ | :------------------------------------ | | April 1, 2025 – April 30, 2025 | 21,598 | $28.12 | | May 1, 2025 – May 31, 2025 | 30,590 | $30.59 | | June 1, 2025 – June 30, 2025 | 4,269 | $31.52 | | **Totals** | **56,457** | **$29.72** | - These purchases were made to satisfy tax withholding obligations related to the vesting of equity awards[139](index=139&type=chunk) - No ordinary shares were purchased under the **$400.0 million** Repurchase Program during the three months ended June 30, 2025, with **$200.0 million** remaining authorized[139](index=139&type=chunk) [Item 5. Other Information](index=38&type=section&id=Item%205.%20Other%20Information) Director Nancy Lurker adopted a Rule 10b5-1 plan on June 13, 2025, to sell up to 2,000 ordinary shares, expiring December 11, 2025. No other officers or directors adopted, modified, or terminated such plans during the quarter - Director Nancy Lurker adopted a Rule 10b5-1 plan on June 13, 2025, to sell up to **2,000 ordinary shares**, with an expiration date of December 11, 2025[140](index=140&type=chunk) - No other officers or directors adopted, modified, or terminated a Rule 10b5-1 plan or a non-Rule 10b5-1(c) trading plan during the three months ended June 30, 2025[140](index=140&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed or furnished as part of this Form 10-Q, including the 2018 Stock Option and Incentive Plan, various certifications, and XBRL documents - Exhibits include the Alkermes plc 2018 Stock Option and Incentive Plan, Rule 13a-14(a)/15d-14(a) Certifications, Certification pursuant to 18 U.S.C. Section 1350, and Inline XBRL Taxonomy Extension Schema Document with Embedded Linkbase Documents[143](index=143&type=chunk)

Financial Data and Key Metrics Changes - The company reported total revenues of $390.7 million for Q2 2025, with net sales from proprietary products at $307.2 million, reflecting a 14% year-over-year growth [15][14] - GAAP net income for the quarter was $87.1 million, with adjusted EBITDA of $126.5 million [17][14] - The company ended the quarter with $1.05 billion in cash and total investments, maintaining a strong financial position [17][36] Business Line Data and Key Metrics Changes - VIVITROL net sales were $121.7 million, driven by growth in the alcohol dependence indication market [18] - ARISTADA net sales reached $101.3 million, with increased prescriber breadth and strong new prescriptions [19] - LYBALVI net sales grew 18% year-over-year to $84.3 million, with underlying TRx growth of 22% [19] Market Data and Key Metrics Changes - The company expects Q3 net sales from its proprietary product portfolio to be in the range of $280 million to $300 million [15] - For the full year 2025, VIVITROL net sales are expected to be between $440 million and $460 million, while ARISTADA is projected to be in the range of $335 million to $355 million [18][19] Company Strategy and Development Direction - The company is focused on accelerating future growth through its development candidates in the pipeline, particularly in the orexin portfolio [8][36] - The successful results from the Vibrance one Phase II study of elixorexant are seen as a critical step in the development of the orexin portfolio [9][21] - The company plans to advance additional orexin candidates for conditions beyond central disorders of hypersomnolence [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving record revenues from proprietary products in 2025, anticipating performance towards the higher end of previously issued financial expectations [17][36] - The management highlighted the importance of the Vibrance one data in understanding orexin biology and its potential across various neuropsychiatric and neurological disorders [35][36] Other Important Information - The company has a remaining share repurchase authorization of $200 million and may opportunistically repurchase shares based on market conditions [17] - The Vibrance one study provided new insights into fatigue and cognition, establishing a new standard in the development of orexin receptor agonists [11][12] Q&A Session Summary Question: Focus on visual adverse events with the Orexin program - Management acknowledged the focus on visual AEs from Wall Street but emphasized the rigorous baseline ophthalmic exams conducted, showing no changes [41][42] Question: Confidence in elixorexant's efficacy compared to competitors - Management expressed confidence in the dose range selected for the NT1 study and the potential competitive advantage it provides [49] Question: Regulatory path and potential for registrational trials - Management indicated that the NT2 study data will be crucial for discussions with the FDA regarding the phase three design [51][52] Question: Safety profile extrapolation to follow-on compounds - Management noted that while similarities are expected due to the same receptor targeting, differences in pharmacokinetic profiles could lead to variations in AE profiles [77][80] Question: Dosing flexibility in Phase III - Management has not finalized dosing plans for Phase III but emphasized the importance of the data from the Phase II studies in making those decisions [90][91]

Financial Data and Key Metrics Changes - The company reported total revenues of $390.7 million for Q2 2025, with proprietary product net sales of $307.2 million, reflecting a 14% year-over-year growth [12][14] - GAAP net income was $87.1 million, with EBITDA of $101.6 million and adjusted EBITDA of $126.5 million for the second quarter [14] - The company ended the quarter with $1.05 billion in cash and total investments, maintaining a strong financial position [14] Business Line Data and Key Metrics Changes - VIVITROL net sales were $121.7 million, driven by growth in the alcohol dependence indication market [17] - ARISTADA net sales reached $101.3 million, with encouraging leading indicators related to underlying demand [17] - LYBALBI net sales grew 18% year-over-year to $84.3 million, with underlying TRx growth of 22% [18] Market Data and Key Metrics Changes - The proprietary product portfolio's net sales exceeded expectations, driven by strong end market demand and favorable gross to net dynamics [17] - The company anticipates Q3 net sales from the proprietary product portfolio in the range of $280 million to $300 million [12] Company Strategy and Development Direction - The company is focused on accelerating future growth through development candidates in its pipeline, particularly in the orexin portfolio [6][34] - The successful results from the Vibrance one Phase II study of elixorextin are seen as a critical step in the development of the orexin portfolio [7][10] - The company plans to advance additional orexin candidates into clinical development later this year [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving record revenues from proprietary products in 2025, anticipating performance towards the higher end of previously issued financial expectations [14][34] - The management highlighted the importance of the positive Vibrance one data as a significant stride forward for the elixorexin development program [33] Other Important Information - The company has a remaining share repurchase authorization of $200 million and may opportunistically repurchase shares depending on market conditions [14] - The company is preparing for key regulatory interactions and plans to initiate a global Phase III program in narcolepsy following the top line data from the narcolepsy type two study [22][34] Q&A Session Summary Question: Focus on visual adverse events with the Orexin program - Management acknowledged the focus on visual AEs from Wall Street and emphasized the importance of the rigorous ophthalmic exams conducted during the study [39][40] Question: Efficacy of elixorextin compared to Takeda's program - Management expressed confidence in the competitive advantage of elixorextin's dosing range and efficacy, awaiting further data from ongoing studies [48] Question: Regulatory path and potential registrational trials - Management indicated that the NT2 study data will be crucial for discussions with the FDA regarding the Phase III design [51][52] Question: Dose response and statistical analysis - Management confirmed the use of negative binomial analysis for cataplexy data and expressed confidence in the clarity of the cataplexy signal [62][63] Question: Potency selectivity of elixorextin - Management confirmed that elixorextin is 5,000-fold more selective towards the orexin 2 receptor over the orexin 1 receptor [70] Question: Safety profile extrapolation to follow-on compounds - Management noted that while similarities are expected due to the same receptor targeting, different pharmacokinetic profiles may lead to variations in safety profiles [74][75] Question: Dosing flexibility in Phase III - Management stated that dosing decisions for Phase III will be informed by the comprehensive data from the Phase II studies [82][110]

Second Quarter 2025 Financial Results & Business Update July 29, 2025 Forward-Looking Statements and Non-GAAP Financial Information Certain statements set forth in this presentation constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: Alkermes plc's (the "Company") expectations with respect to its current and future financial, commercial and operating performance, business plans o ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) Alkermes reported strong Q2 2025 performance with **$390.7 million** total revenues, **$87.1 million** GAAP Net Income, and **$0.52** diluted EPS | Metric | Q2 2025 | | :--- | :--- | | **Total Revenues** | $390.7 Million | | **GAAP Net Income** | $87.1 Million | | **Diluted GAAP EPS** | $0.52 | - CEO Richard Pops highlighted strong performance across all three proprietary products, robust profitability, and significant cash flow generation[1](index=1&type=chunk) - The company announced positive topline results from its Vibrance-1 phase 2 study of alixorexton (ALKS 2680) in narcolepsy type 1 and plans to present detailed results at the upcoming World Sleep Congress[1](index=1&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) Alkermes generated **$390.7 million** in Q2 2025 total revenues, with proprietary product net sales up **14%** year-over-year [Revenues](index=1&type=section&id=Revenues) Q2 2025 total revenues reached **$390.7 million**, primarily driven by **14%** growth in proprietary product net sales | Revenue Source (In millions) | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | **$390.7** | **$399.1** | **-2.1%** | | Total Proprietary Net Sales | $307.2 | $269.3 | +14.1% | | VIVITROL® | $121.7 | $111.9 | +8.8% | | ARISTADA® | $101.3 | $86.0 | +17.8% | | LYBALVI® | $84.3 | $71.4 | +18.1% | - The company recorded revenue of approximately **$11.0 million** for ARISTADA and **$9.0 million** for VIVITROL related to gross-to-net favorability, primarily from Medicaid utilization adjustments[9](index=9&type=chunk) | Manufacturing & Royalty Revenue (In millions) | Q2 2025 | | :--- | :--- | | VUMERITY® | $39.4 | | XEPLION®, INVEGA TRINZA®/TREVICTA®, etc. | $30.3 | [Profitability](index=1&type=section&id=Profitability) Q2 2025 GAAP Net Income from continuing operations was **$87.1 million**, with diluted GAAP EPS at **$0.52** | Profitability Metric (In millions) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | GAAP Net Income From Continuing Operations | $87.1 | $94.7 | | EBITDA From Continuing Operations | $101.6 | $118.6 | | Adjusted EBITDA | $126.5 | $135.3 | | Diluted GAAP EPS | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | From continuing operations | $0.52 | $0.55 | | From net income | $0.52 | $0.53 | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) R&D expenses from continuing operations increased to **$77.4 million** in Q2 2025, while SG&A remained stable | Expense (Continuing Ops, In millions) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expense | $77.4 | $59.6 | | SG&A Expense | $170.8 | $168.1 | [Balance Sheet](index=2&type=section&id=Balance%20Sheet) Alkermes ended Q2 2025 with a strong cash position, with total investments reaching **$1.05 billion** - As of June 30, 2025, the company's cash, cash equivalents, and total investments were **$1.05 billion**[6](index=6&type=chunk) | Cash & Investments (In millions) | June 30, 2025 | March 31, 2025 | | :--- | :--- | :--- | | Cash, cash equivalents and total investments | $1,054.0 | $916.2 | [Business Outlook](index=2&type=section&id=Business%20Outlook) Alkermes confirmed its full-year 2025 financial guidance, reiterating expectations from February 12, 2025 - The company reiterates its financial expectations for 2025, as originally set forth on February 12, 2025[7](index=7&type=chunk) [Appendix: Detailed Financial Statements](index=5&type=section&id=Appendix%3A%20Detailed%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements, including Statements of Operations and Balance Sheets [Condensed Consolidated Statements of Operations (Quarterly)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%28Quarterly%29) Q2 2025 saw **$390.7 million** total revenues, **$93.0 million** operating income, and **$87.1 million** GAAP Net Income | Q2 Statement of Operations (In thousands) | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | **Total Revenues** | **$390,657** | **$399,131** | | Total Expenses | $297,679 | $289,248 | | **Operating Income** | **$92,978** | **$109,883** | | Net Income From Continuing Operations | $87,098 | $94,658 | | **Net Income — GAAP** | **$87,098** | **$91,358** | | Diluted GAAP EPS | $0.52 | $0.53 | [Condensed Consolidated Statements of Operations (Year-to-Date)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%28Year-to-Date%29) YTD June 30, 2025, total revenues were **$697.2 million**, with operating income at **$106.8 million** | YTD Statement of Operations (In thousands) | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | **Total Revenues** | **$697,167** | **$749,503** | | Total Expenses | $590,397 | $596,311 | | **Operating Income** | **$106,770** | **$153,192** | | Net Income From Continuing Operations | $109,562 | $133,606 | | **Net Income — GAAP** | **$109,562** | **$128,186** | | Diluted GAAP EPS | $0.65 | $0.75 | [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were **$2.25 billion**, with shareholders' equity at **$1.62 billion** | Balance Sheet (In thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and total investments | $1,054,008 | $824,816 | | **Total Assets** | **$2,252,809** | **$2,055,567** | | Total shareholders' equity | $1,624,584 | $1,464,977 | | **Total Liabilities and Shareholders' Equity** | **$2,252,809** | **$2,055,567** | [Other Information](index=3&type=section&id=Other%20Information) This section provides conference call details, company overview, non-GAAP financial measures, and forward-looking statements [Conference Call Information](index=3&type=section&id=Conference%20Call%20Information) A conference call and webcast to discuss Q2 financial results is scheduled for 8:00 a.m. ET on July 29, 2025 - A conference call and webcast to discuss financial results is scheduled for 8:00 a.m. ET on July 29, 2025[10](index=10&type=chunk) [About Alkermes plc](index=3&type=section&id=About%20Alkermes%20plc) Alkermes plc is a global biopharmaceutical company focused on neuroscience, with a commercial portfolio and clinical pipeline - Alkermes is a global biopharmaceutical company specializing in neuroscience with a portfolio of commercial products for addiction and psychiatric disorders, and a development pipeline for neurological conditions[11](index=11&type=chunk) [Non-GAAP Financial Measures & Forward-Looking Statements](index=3&type=section&id=Non-GAAP%20Financial%20Measures%20%26%20Forward-Looking%20Statements) The report uses non-GAAP financial measures and contains forward-looking statements subject to inherent risks - The press release includes non-GAAP financial measures like EBITDA and Adjusted EBITDA, which are not prepared in accordance with GAAP but are used by management to evaluate performance[12](index=12&type=chunk)[14](index=14&type=chunk) - The report contains forward-looking statements concerning future financial performance and development timelines, which are inherently uncertain and subject to risks[16](index=16&type=chunk)[17](index=17&type=chunk)

Core Insights - Alkermes plc reported strong financial performance in Q2 2025, with significant growth in proprietary product sales and robust profitability [2][6][3] - The company announced positive topline results from the Vibrance-1 study of alixorexton for narcolepsy type 1, marking a key milestone in its development program [2][6] Financial Performance - Total revenues for Q2 2025 were $390.7 million, a decrease from $399.1 million in Q2 2024 [3] - Proprietary net sales increased to $307.2 million in Q2 2025, up from $269.3 million in Q2 2024, representing a growth of 14% [3][7] - Key product sales included VIVITROL® at $121.7 million (up 9% YoY), ARISTADA® at $101.3 million (up 18% YoY), and LYBALVI® at $84.3 million (up 18% YoY) [3][7] Profitability Metrics - GAAP net income for Q2 2025 was $87.1 million, compared to $91.4 million in Q2 2024 [4] - Adjusted EBITDA for Q2 2025 was $126.5 million, down from $135.3 million in Q2 2024 [4][26] - The company maintained a GAAP earnings per share of $0.52 for Q2 2025, slightly down from $0.53 in Q2 2024 [24] Research and Development - R&D expenses for continuing operations were $77.4 million in Q2 2025, an increase from $59.6 million in Q2 2024, reflecting the company's commitment to advancing its pipeline [9] - The company is preparing to initiate a global phase 3 program for alixorexton and will present detailed results from the Vibrance-1 study at the World Sleep Congress [2][6] Balance Sheet Highlights - As of June 30, 2025, Alkermes had cash, cash equivalents, and total investments of $1.05 billion, an increase from $916.2 million at the end of Q1 2025 [10][27] - Total assets reached $2.25 billion, up from $2.06 billion at the end of 2024 [27] Future Outlook - Alkermes reiterated its financial expectations for 2025, indicating confidence in its ongoing operations and product pipeline [11]

Company Overview - Alkermes is expected to report a year-over-year decline in earnings, with a projected EPS of $0.41, reflecting a decrease of 43.1% compared to the previous year [3] - Revenues are anticipated to be $338.69 million, down 15.1% from the same quarter last year [3] Earnings Expectations - The earnings report is scheduled for July 29, and the actual results will significantly influence the stock price, depending on whether they meet or exceed expectations [2] - The consensus EPS estimate has been revised 1.03% lower in the last 30 days, indicating a reassessment by analysts [4] Earnings Surprise Prediction - The Most Accurate Estimate for Alkermes is higher than the Zacks Consensus Estimate, resulting in a positive Earnings ESP of +4.94%, suggesting a likelihood of beating the consensus EPS estimate [12] - Alkermes currently holds a Zacks Rank of 3, which indicates a neutral outlook [12] Historical Performance - In the last reported quarter, Alkermes had an expected EPS of $0.28 but only delivered $0.13, resulting in a surprise of -53.57% [13] - Over the past four quarters, the company has only beaten consensus EPS estimates once [14] Industry Context - In the Zacks Medical - Biomedical and Genetics industry, Exelixis is expected to report earnings of $0.63 per share, reflecting a year-over-year decline of 25% [18] - Exelixis has a higher Most Accurate Estimate leading to an Earnings ESP of +2.52% and a Zacks Rank of 2, indicating a strong likelihood of beating the consensus EPS estimate [19]

Core Insights - Alkermes (ALKS) announced positive top-line data from the phase II Vibrance-1 study for its oral orexin 2 receptor agonist, alixorexton, aimed at treating narcolepsy type 1 (NT1) [1][8] - The study demonstrated statistically significant improvements in wakefulness and excessive daytime sleepiness compared to placebo [2][3] - The 6 mg dose of alixorexton was the only one to achieve statistical significance in reducing weekly cataplexy rates, which may have negatively impacted investor sentiment [4] Study Results - Alixorexton treatment across all doses showed a dose-dependent improvement in wakefulness on the Maintenance of Wakefulness Test (MWT), the primary endpoint of the study [2] - Statistically significant improvements in excessive daytime sleepiness were observed at week six on the Epworth Sleepiness Scale, a key secondary endpoint [3] - The 6 mg dose was the only one to achieve statistical significance in improving weekly cataplexy rates, another key secondary endpoint [4] Safety and Tolerability - Treatment with alixorexton was generally safe and well-tolerated across all doses [5] Future Development Plans - Alkermes plans to initiate a global phase III trial for alixorexton in patients with NT1, building on the success of the Vibrance-1 study [9][10] - Alixorexton is also being studied for narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), with ongoing phase II studies [11][12] Competitive Landscape - Upon potential approval, alixorexton may face competition from Axsome's Sunosi (solriamfetol), which is already marketed for narcolepsy treatment [13] - Other drugs from Jazz Pharmaceuticals, such as Xyrem and Xywav, also hold significant market share in the sleep disorder segment [14]

Core Insights - Alixorexton demonstrated clinically meaningful and statistically significant improvements in wakefulness in patients with narcolepsy type 1 compared to placebo [1][2][3] - The drug showed robust improvements in patient-reported outcomes related to disease severity, fatigue, and cognition across all doses tested [1][2] - Alixorexton was generally well tolerated, with no serious adverse events reported during the study [1][5] Study Details - The Vibrance-1 phase 2 study involved 92 patients with narcolepsy type 1, randomized to receive alixorexton at doses of 4 mg, 6 mg, or 8 mg, or placebo for six weeks [2][7] - The primary endpoint was the Maintenance of Wakefulness Test (MWT), where alixorexton showed statistically significant improvements in mean sleep latency at week six (p<0.0001) [3][9] - Secondary endpoints included the Epworth Sleepiness Scale (ESS) and weekly cataplexy rates, with significant improvements noted at the 6 mg dose (p=0.005) [9] Patient-Reported Outcomes - Alixorexton led to significant improvements in excessive daytime sleepiness (ESS) (p<0.0001), narcolepsy symptom severity (NSS) (p<0.001), cognitive complaints (BC-CCI) (p<0.0001), and fatigue (PROMIS-Fatigue) (p<0.01) [9] - The study highlighted the breadth of benefits that alixorexton may provide across multiple facets of narcolepsy, addressing persistent symptoms that disrupt daily life [2] Future Developments - Alkermes plans to present detailed results from the Vibrance-1 study at the World Sleep Congress in September 2025 [6] - The company is moving forward with a global phase 3 program for alixorexton in patients with narcolepsy type 1 based on the positive outcomes from the phase 2 study [2][6]