Core Points - Alkermes plc held a conference call to discuss the results of the Vibrance-1 Phase II study of alixorexton in patients with narcolepsy type 1 [2] Group 1 - The conference call featured key executives including the CEO Richard Pops and Chief Medical Officer Dr. Craig Hopkinson, along with the lead investigator Professor Giuseppe Plazzi [2] - A press release and slide presentation related to the study results were made available on the Investors section of alkermes.com [2]

Company Overview - CoinShares, a cryptocurrency asset manager listed in Sweden, is preparing to go public in the U.S. through a SPAC agreement, which will value the company at $1.2 billion and lead to its delisting from the Swedish market [2] - The company currently manages approximately $10 billion in assets, a figure that has tripled over the last two years, and has expanded its product offerings from four in 2021 to a suite of 32 products across four platforms [4] Market Position - CoinShares is recognized as the fourth-largest manager of digital asset ETP products globally, following BlackRock, Grayscale, and Fidelity, and holds the top position in Europe, the Middle East, and Africa with a 34% market share [3] Industry Context - The U.S. is becoming a central hub for digital assets, with CoinShares aiming to capitalize on the growing investor demand and favorable regulatory environment for cryptocurrencies [3] - The trend of crypto firms going public in the U.S. is gaining momentum, with other companies like Circle and Bullish successfully listing, indicating a shift in traditional finance's openness to digital assets [5][6]

Core Insights - Alkermes plc announced positive results from the Vibrance-1 phase 2 study of alixorexton, a novel orexin 2 receptor agonist for narcolepsy type 1, demonstrating significant improvements in wakefulness, cognition, and fatigue with once-daily dosing [1][2][4] Study Results - The Vibrance-1 study involved 92 patients and showed statistically significant improvements in mean sleep latency on the Maintenance of Wakefulness Test (MWT) at week six, with mean sleep latencies of approximately 24, 26, and 28 minutes for the 4 mg, 6 mg, and 8 mg doses respectively, compared to a baseline of about 3 minutes [4][5] - Alixorexton also achieved significant improvements in the Epworth Sleepiness Scale (ESS) scores, with baseline scores of 18.5 and reductions to the normal range (a score of 10) across all doses [4][5] - More than 40% of patients on the 6 mg and 8 mg doses experienced a 100% reduction in cataplexy during week six [4][5] Safety Profile - Alixorexton was generally well tolerated across all tested doses, with no serious treatment-emergent adverse events reported [6][4] - The most common mild to moderate adverse events included pollakiuria, insomnia, and blurred vision, with most events resolving within the first week of treatment [6][4] Future Plans - Alkermes plans to initiate a global phase 3 program for alixorexton in the first quarter of 2026, following the positive phase 2 results [8][4] - The company is also advancing other orexin-targeted therapeutics into first-in-human studies this year [8]

Core Viewpoint - Alkermes reported a strong second quarter for 2025, with earnings and proprietary product sales exceeding expectations, despite a slight decline in total revenues compared to the previous year [2][3][5]. Financial Performance - Alkermes reported earnings from continuing operations of 52 cents per share, beating the Zacks Consensus Estimate of 41 cents and slightly lower than 53 cents per share from the year-ago quarter [2]. - Total revenues for the second quarter were $390.7 million, a decrease of 2.1% year over year, but significantly above the Zacks Consensus Estimate of $339 million [3]. - Sales from proprietary products grew 14% year over year to $307.2 million, surpassing management's expectations of $260-$280 million [5]. Product Sales Breakdown - Vivitrol sales increased 9% year over year to $121.7 million, exceeding the Zacks Consensus Estimate of $111 million [6]. - Aristada sales rose 18% year over year to $101.3 million, beating the Zacks Consensus Estimate of $84 million [6]. - Lybalvi generated sales of $84.3 million, up 18% year over year, also surpassing the Zacks Consensus Estimate of $79 million [7]. Revenue Sources - Alkermes' revenue sources include net sales from proprietary products and manufacturing/royalty revenues from partnered products [4]. - Manufacturing and royalty revenues decreased 35.8% year over year to $83.4 million, with specific contributions from Biogen's Vumerity and other products [7][8]. Expenses and Cash Position - Research and development expenses increased by almost 30% year over year to $77.4 million, driven by ongoing studies on pipeline candidate alixorexton [8]. - As of June 30, 2025, Alkermes had cash and cash equivalents of $1.05 billion, up from $916.2 million as of March 31, 2025 [9]. Guidance and Estimates - Alkermes reiterated its financial guidance for 2025, expecting total revenues of $1.34-$1.43 billion [10]. - The company anticipates net sales of Vivitrol to be $440-$460 million, Aristada sales to be $335-$355 million, and Lybalvi's net sales to be in the range of $320-$340 million [11]. Market Position and Trends - Estimates for Alkermes have trended downward recently, with a consensus estimate shift of -14.21% [12]. - Alkermes holds a Zacks Rank 3 (Hold), indicating an expectation of in-line returns in the coming months [14].

Core Insights - Alkermes plc is set to present detailed results from its Vibrance-1 phase 2 study on alixorexton for narcolepsy type 1 at the World Sleep Congress in Singapore from September 5-10, 2025, and during an investor webcast on September 8, 2025 [1][2][7] Company Overview - Alkermes plc is a mid-cap global biopharmaceutical company focused on developing innovative medicines in neuroscience, with a portfolio addressing various neurological disorders including narcolepsy and idiopathic hypersomnia [10] Study Details - The Vibrance-1 study is a phase 2, randomized, double-blind, placebo-controlled trial involving 92 participants, evaluating the safety and efficacy of alixorexton in adults with narcolepsy type 1 [8] - Participants were assigned to receive one of three doses of alixorexton (4 mg, 6 mg, or 8 mg) or placebo once daily for six weeks, with primary and secondary endpoints focusing on wakefulness and other narcolepsy symptoms [8] Presentation Highlights - Three oral presentations will cover the safety and efficacy of alixorexton, improvements in fatigue and cognitive function, and the study design for the Vibrance-3 study evaluating alixorexton in idiopathic hypersomnia [4][5][6] - The presentations will take place during the "Targeting the orexin pathway: Emerging pharmacotherapies for narcolepsy type 1" session on September 8, 2025 [4] Research Community Engagement - The World Sleep Congress will feature leading researchers and clinicians discussing new datasets on orexin 2 receptor agonists, highlighting the ongoing commitment to improving care for patients with hypersomnolence disorders [2][3]

Group 1 - The article highlights Alkermes plc (NASDAQ: ALKS) as a focus for investment discussions, particularly in the context of covered call opportunities in the biotech sector [1] - Alkermes recently reported its quarterly results, marking the first analysis of the company since the previous article published nearly a year ago [1] - The Biotech Forum, led by Bret, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live discussions and weekly updates on market commentary and portfolio performance [1] Group 2 - The article does not provide any specific financial metrics or performance data for Alkermes plc [3]

Core Insights - Alkermes plc reported earnings from continuing operations of 52 cents per share for Q2 2025, surpassing the Zacks Consensus Estimate of 41 cents and slightly down from 53 cents in the same quarter last year [1] - Total revenues for the second quarter were $390.7 million, a decrease of 2.1% year-over-year, primarily due to lower manufacturing and royalty revenues, but still exceeding the Zacks Consensus Estimate of $339 million [1][6] Financial Performance - Proprietary product sales increased by 14% year-over-year to $307.2 million, driven by strong demand for Vivitrol, Aristada, and Lybalvi, exceeding management's expectations of $260-$280 million [4][6] - Manufacturing and royalty revenues fell by 35.8% year-over-year to $83.4 million, negatively impacting overall revenue performance [6][8] - Research and development expenses rose by nearly 30% year-over-year to $77.4 million, attributed to higher costs related to ongoing studies for the investigational pipeline candidate, alixorexton [9] Product Sales Breakdown - Vivitrol sales grew by 9% year-over-year to $121.7 million, surpassing the Zacks Consensus Estimate of $111 million [7] - Aristada sales increased by 18% year-over-year to $101.3 million, exceeding the Zacks Consensus Estimate of $84 million [7] - Lybalvi generated sales of $84.3 million, up 18% year-over-year, also beating the Zacks Consensus Estimate of $79 million [8] Guidance and Future Outlook - Alkermes reiterated its 2025 financial guidance, expecting total revenues between $1.34 billion and $1.43 billion, with specific net sales targets for Vivitrol, Aristada, and Lybalvi [11] - The company is planning to initiate a global phase III program for alixorexton in patients with narcolepsy type 1 following positive results from the phase II Vibrance-1 study [12][14] Pipeline Development - The phase II Vibrance-1 study showed statistically significant improvements in wakefulness for patients treated with alixorexton compared to placebo [13] - Alixorexton is also being studied for narcolepsy type 2 and idiopathic hypersomnia, with data from the Vibrance-2 study expected in the fall [15][16]

Core Insights - Alkermes reported revenue of $390.66 million for the quarter ended June 2025, reflecting a year-over-year decline of 2.1% and an EPS of $0.52 compared to $0.72 a year ago, exceeding the Zacks Consensus Estimate of $338.57 million by 15.38% and delivering an EPS surprise of 26.83% [1] Revenue Breakdown - Manufacturing and Royalty revenues were $83.42 million, surpassing the average estimate of $61.5 million, but showing a year-over-year decline of 35.8% [4] - Product sales, net, reached $307.24 million, exceeding the estimated $276.98 million and representing a year-over-year increase of 14.1% [4] - Proprietary Sales for VIVITROL amounted to $121.7 million, above the estimated $111.47 million, marking an 8.8% increase year-over-year [4] - Proprietary Sales for ARISTADA were $101.3 million, exceeding the average estimate of $84.2 million, with a year-over-year growth of 17.8% [4] - Proprietary Sales for LYBALVI reached $84.3 million, compared to the estimated $79.41 million, reflecting an 18.1% year-over-year increase [4] - Manufacturing and Royalty Revenues for VUMERITY were $39.4 million, surpassing the estimated $27.92 million, with an 11.9% year-over-year increase [4] Stock Performance - Alkermes shares have returned -8.6% over the past month, contrasting with the Zacks S&P 500 composite's +3.6% change, and the stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market [3]

分组1 - Alkermes reported quarterly earnings of $0.52 per share, exceeding the Zacks Consensus Estimate of $0.41 per share, but down from $0.72 per share a year ago, representing an earnings surprise of +26.83% [1] - The company posted revenues of $390.66 million for the quarter, surpassing the Zacks Consensus Estimate by 15.38%, although this is a decrease from year-ago revenues of $399.13 million [2] - Over the last four quarters, Alkermes has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] 分组2 - The stock has underperformed the market, losing about 9.1% since the beginning of the year compared to the S&P 500's gain of 8.6% [3] - The current consensus EPS estimate for the coming quarter is $0.48 on revenues of $353.2 million, and for the current fiscal year, it is $1.81 on revenues of $1.37 billion [7] - The Medical - Biomedical and Genetics industry, to which Alkermes belongs, is currently in the top 38% of Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

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)