Part I [Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Alkermes' unaudited condensed consolidated financial statements for Q1 2025, including balance sheets, statements of operations, cash flows, and shareholders' equity, are presented with detailed notes Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$2,081,977** | **$2,055,567** | | Cash and cash equivalents | $399,806 | $291,146 | | Total current assets | $1,479,050 | $1,415,355 | | **Total Liabilities** | **$570,394** | **$590,590** | | Total current liabilities | $443,730 | $465,199 | | **Total Shareholders' Equity** | **$1,511,583** | **$1,464,977** | Condensed Consolidated Statement of Operations Highlights (in thousands) | Account | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenues | $306,510 | $350,372 | | Total expenses | $292,718 | $307,063 | | Operating income from continuing operations | $13,792 | $43,309 | | **Net income from continuing operations** | **$22,464** | **$38,948** | | **Net income** | **$22,464** | **$36,828** | | **Diluted EPS from continuing operations** | **$0.13** | **$0.23** | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Cash flows provided by operating activities | $98,811 | $21,108 | | Cash flows provided by (used in) investing activities | $9,102 | $(39,951) | | Cash flows provided by (used in) financing activities | $747 | $(17,873) | | **Net increase (decrease) in cash** | **$108,660** | **$(36,716)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Net income from continuing operations decreased to **$22.5 million** in Q1 2025, primarily due to a **$54.8 million** decline in manufacturing and royalty revenues, partially offset by increased product sales and reduced operating expenses - The decrease in net income was primarily due to a **$54.8 million** fall in manufacturing and royalty revenue, partially offset by an **$11.0 million** increase in net product sales and a **$14.4 million** decrease in operating expenses[78](index=78&type=chunk) Net Product Sales (in millions) | Product | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | VIVITROL | $101.0 | $97.7 | $3.3 | | ARISTADA and ARISTADA INITIO | $73.5 | $78.9 | $(5.4) | | LYBALVI | $70.0 | $57.0 | $13.0 | | **Total** | **$244.5** | **$233.5** | **$10.9** | Manufacturing and Royalty Revenues (in millions) | Revenue Source | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Long-acting INVEGA products | $17.7 | $62.7 | $(45.0) | | VUMERITY | $27.8 | $31.3 | $(3.5) | | RISPERDAL CONSTA | $9.1 | $2.7 | $6.4 | | Other | $7.4 | $20.1 | $(12.7) | | **Total** | **$62.0** | **$116.8** | **$(54.8)** | - The decrease in royalty revenues from long-acting INVEGA products was primarily due to the expiration of the U.S. royalty on INVEGA SUSTENNA net sales in August 2024[106](index=106&type=chunk) - R&D expenses increased by **$4.2 million**, driven by a **$7.3 million** increase in spending on the ALKS 2680 development program for narcolepsy and idiopathic hypersomnia[109](index=109&type=chunk)[110](index=110&type=chunk) - Cash and investments increased to **$916.2 million** at March 31, 2025, up from **$824.7 million** at December 31, 2024[115](index=115&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company reports no material changes to its market risks since December 31, 2024, with key exposures including investment portfolio and Euro currency fluctuations from Irish operations - There have been no material changes to the company's market risks since December 31, 2024[129](index=129&type=chunk) - The company is exposed to non-U.S. currency exchange risk, primarily from Euro-denominated expenses related to its Irish operations[130](index=130&type=chunk) - Investment objectives are to preserve capital, provide liquidity, and generate investment income, managed through a diversified portfolio[117](index=117&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The principal executive officer and interim principal financial officer concluded that disclosure controls and procedures were effective as of March 31, 2025[132](index=132&type=chunk) - There were no material changes in the company's internal control over financial reporting during the first quarter of 2025[133](index=133&type=chunk) Part II [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in patent infringement litigation for INVEGA TRINZA and VUMERITY, a government investigation regarding VIVITROL, and product liability claims - The U.S. Court of Appeals affirmed a lower court decision in favor of Janssen regarding the patent for INVEGA TRINZA, a product from which Alkermes receives royalties[70](index=70&type=chunk) - The company is involved in patent infringement litigation against Zydus, which is seeking to market a generic version of VUMERITY, with a bench trial scheduled for July 28, 2025[71](index=71&type=chunk) - The company has received a subpoena and civil investigative demands from U.S. state and federal authorities regarding VIVITROL and is cooperating with the investigations[72](index=72&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor highlights the potential adverse impact of changes in global trade policies, including tariffs, on the company's international supply chain and revenue - A new risk factor was added regarding the adverse effects of changes in global trade policies, including tariffs imposed by the U.S. and other nations[137](index=137&type=chunk) - The company's supply chain for proprietary products and manufacturing of third-party products from which it derives revenue have international components, creating exposure to tariffs and trade policy changes[137](index=137&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Alkermes did not repurchase shares under its public program in Q1 2025, instead acquiring **834,590** shares for tax withholding, with **$200 million** remaining authorized Share Repurchase Activity - Q1 2025 | Period | Total Shares Purchased | Avg. Price Paid | Purchased as Part of Program | Remaining Program Value (millions) | | :--- | :--- | :--- | :--- | :--- | | Jan 2025 | 1,879 | $28.67 | — | $200.0 | | Feb 2025 | 832,359 | $34.50 | — | $200.0 | | Mar 2025 | 352 | $34.40 | — | $200.0 | | **Total** | **834,590** | **$34.49** | **—** | **$200.0** | - All shares purchased during the quarter were acquired to satisfy tax withholding obligations related to the vesting of equity awards, not as part of the public repurchase program[140](index=140&type=chunk) - As of March 31, 2025, **$200.0 million** remains authorized under the share repurchase program announced in February 2024[140](index=140&type=chunk) [Other Information](index=36&type=section&id=Item%205.%20Other%20Information) This section details the adoption and termination of Rule 10b5-1 trading plans by company officers and directors during Q1 2025 - Several officers and a director adopted or terminated Rule 10b5-1 trading plans for the sale of company shares during the quarter[141](index=141&type=chunk) [Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications and Interactive Data Files (XBRL) for financial reporting - The exhibits filed with the 10-Q include officer certifications under Rule 13a-14(a)/15d-14(a) and Section 906 of the Sarbanes-Oxley Act, as well as XBRL data files[143](index=143&type=chunk)

Core Insights - Alkermes reported a revenue of $306.51 million for the quarter ended March 2025, reflecting a 12.5% decrease year-over-year [1] - The earnings per share (EPS) was $0.13, down from $0.44 in the same quarter last year, indicating a significant decline [1] - The revenue fell short of the Zacks Consensus Estimate of $316.7 million, resulting in a surprise of -3.22% [1] - The company experienced an EPS surprise of -53.57%, with the consensus EPS estimate being $0.28 [1] Revenue Breakdown - Manufacturing and Royalty revenues were reported at $62.02 million, below the five-analyst average estimate of $65.33 million, marking a year-over-year decline of 46.9% [4] - Product sales, net, amounted to $244.49 million, slightly below the estimated $254.16 million, but showed a year-over-year increase of 4.7% [4] - Proprietary Sales for VIVITROL reached $101 million, exceeding the four-analyst average estimate of $98.71 million, with a year-over-year growth of 3.4% [4] - Proprietary Sales for ARISTADA were reported at $73.50 million, below the estimated $78.52 million, reflecting a year-over-year decrease of 6.8% [4] - Proprietary Sales for LYBALVI were $70 million, close to the estimated $70.91 million, showing a year-over-year increase of 22.8% [4] - Key Commercial Product Revenues for VUMERITY were $27.80 million, slightly below the three-analyst average estimate of $27.81 million, with a year-over-year decline of 11.1% [4] Stock Performance - Alkermes shares have returned -11.9% over the past month, contrasting with the Zacks S&P 500 composite's -0.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Core Insights - Alkermes reported quarterly earnings of $0.13 per share, missing the Zacks Consensus Estimate of $0.28 per share, and down from $0.44 per share a year ago, representing an earnings surprise of -53.57% [1] - The company posted revenues of $306.51 million for the quarter, missing the Zacks Consensus Estimate by 3.22%, and down from $350.37 million year-over-year [2] - Alkermes has surpassed consensus EPS estimates only once in the last four quarters, while it has topped revenue estimates two times in the same period [2] Earnings Outlook - The sustainability of Alkermes' stock price movement will depend on management's commentary during the earnings call and future earnings expectations [3] - The current consensus EPS estimate for the upcoming quarter is $0.46 on revenues of $346.92 million, and for the current fiscal year, it is $1.76 on revenues of $1.39 billion [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Alkermes belongs, is currently ranked in the top 32% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Alkermes' stock performance [5]

Financial Performance - Q1 2025 - Total revenue decreased to $306.5 million from $350.4 million in Q1 2024 [7] - GAAP net income decreased to $22.5 million from $36.8 million in Q1 2024 [7] - GAAP earnings per share (diluted) decreased to $0.13 from $0.21 in Q1 2024 [7] - Adjusted EBITDA decreased to $45.6 million from $81.8 million in Q1 2024 [10] - The decrease in revenue and profitability reflects the expiration of royalty on U S net sales of INVEGA SUSTENNA® in August 2024 [8, 11] Revenue Breakdown - Q1 2025 - Total proprietary net sales increased to $244.5 million from $233.5 million in Q1 2024 [12] - VIVITROL® net sales were $101.0 million, compared to $97.7 million in Q1 2024 [12] - ARISTADA® net sales were $73.5 million, compared to $78.9 million in Q1 2024 [12] - LYBALVI® net sales were $70.0 million, reflecting a 23% growth compared to $57.0 million in Q1 2024 [12, 21] Financial Expectations - 2025 - Total revenues are expected to range from $1,340 million to $1,430 million [13] - GAAP net income is projected to be between $175 million and $205 million [13] - Adjusted EBITDA is projected to be between $310 million and $340 million [13] - VIVITROL® net sales are expected to range from $440 million to $460 million [17] - ARISTADA® net sales are expected to range from $335 million to $355 million [17] - LYBALVI® net sales are expected to range from $320 million to $340 million [17]

Financial Data and Key Metrics Changes - The company reported total revenues of $306.5 million for Q1 2025, slightly above expectations, driven by a 5% year-over-year growth in proprietary product sales [17][18] - Net sales from proprietary products were $244.5 million, with a GAAP net income of $22.5 million and adjusted EBITDA of $45.6 million [13][19][20] - The company ended the quarter with $916.2 million in cash and investments, maintaining a strong financial position [20] Business Line Data and Key Metrics Changes - VIVITROL net sales were $101 million, primarily driven by alcohol dependence, which accounts for approximately 75% of its volume [13] - ARISTADA product family generated net sales of $73.5 million, with expectations for 2025 in the range of $335 million to $355 million [13] - LIVALVI saw a 23% year-over-year growth in net sales to $70 million, driven by a 22% increase in TRx growth [13][14] Market Data and Key Metrics Changes - The company noted that Medicaid coverage for its products is approximately 45% to 50% across VIVITROL, LYBOLVI, and ARISTADA [71] - The first quarter performance was slightly ahead of expectations, indicating a solid start to 2025 [15] Company Strategy and Development Direction - The company is focused on maximizing the potential of its commercial products while advancing its Orexin portfolio, particularly the ALKS 2680 Phase II program [8][9] - Strategic investments are being made to drive awareness and uptake of psychiatry franchise products, including an expanded sales force [14] - The company is preparing for key data readouts from the ALKS 2680 Phase II studies later this year, which are expected to provide substantial datasets [16][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the current macroeconomic conditions, highlighting the company's U.S.-based manufacturing and supply chain as advantageous [12][16] - The focus remains on advocating for policies that maintain access to care for patient populations and supporting regulatory work streams [32] - The company anticipates a pivotal year with transformative data expected in the second half of 2025 [11][31] Other Important Information - The company has a remaining share repurchase authorization of $200 million and may opportunistically repurchase shares depending on market conditions [20] - The Phase II studies for ALKS 2680 are advancing with strong momentum, with top-line results expected early in Q3 for the NT1 study [10][11] Q&A Session Summary Question: Update on NT2 study endpoints - The NT2 study has dual primary endpoints of mean wakefulness tests and Epworth Sleepiness Scale due to competitive landscape considerations [36] Question: Contribution of scripts from schizophrenia and bipolar for LIVALVI - The TRx split for LIVALVI is roughly 50/50 between schizophrenia and bipolar, with a trend towards 55% for bipolar in new patient starts [42][44] Question: Safety data from Orexin studies - An independent data safety monitoring board oversees safety across the study, with no modifications required at this time [50] Question: Contribution of volume versus price to sales - The majority of sales expectations are based on volume growth, with Medicaid coverage for products around 45% to 50% [70][71] Question: Future of VIVITROL with potential generic competition - The company believes VIVITROL will not follow a typical generic erosion curve due to its complex manufacturing and market dynamics [102]

Financial Data and Key Metrics Changes - The company reported total revenues of $306.5 million for Q1 2025, slightly ahead of expectations, driven by a 5% year-over-year growth in proprietary product sales [20][21] - Net sales from proprietary products were $244.5 million, with expectations for Q2 net sales in the range of $260 million to $280 million [14][21] - GAAP net income for Q1 was $22.5 million, with adjusted EBITDA of $45.6 million [22][23] Business Line Data and Key Metrics Changes - VIVITROL net sales were $101 million, primarily driven by alcohol dependence, which accounts for approximately 75% of VIVITROL volume [14] - ARISTADA product family net sales were $73.5 million, with expectations for 2025 net sales in the range of $335 million to $355 million [14] - LIVALVI net sales grew 23% year-over-year to $70 million, with underlying TRx growth of 22% [14][15] Market Data and Key Metrics Changes - The company maintains a strong financial position with over $900 million in cash and investments [18] - Approximately 45% to 50% of VIVITROL, LIVALVI, and ARISTADA sales are covered by Medicaid [76] Company Strategy and Development Direction - The company is focused on maximizing the potential of its commercial products and driving growth and profitability [10] - The ALKS 2680 Phase II program is expected to generate substantial datasets for narcolepsy studies, with top-line results anticipated early in Q3 2025 [11][12] - The company is preparing for potential Phase III studies based on the outcomes of the ongoing Phase II studies [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the current macroeconomic conditions, emphasizing the importance of U.S.-based manufacturing and supply chain [19][36] - The company is focused on advocating for policies that maintain access to care for patient populations amid changing regulatory environments [37] Other Important Information - The company has a remaining share repurchase authorization of $200 million and may opportunistically repurchase shares depending on market conditions [23] - The company is advancing its research into new disease areas for orexin-two receptor agonists, with plans to start clinical work this year [26][34] Q&A Session Summary Question: Update on NT2 study endpoints - The NT2 study has dual primary endpoints of mean wakefulness tests and Epworth Sleepiness Scale due to competitive landscape considerations [41][43] Question: Contribution of LIVALVI from schizophrenia and bipolar - LIVALVI TRxs are roughly a 50/50 split between schizophrenia and bipolar, with a trend towards 55% for bipolar in new patient starts [47][48] Question: Safety data from orexin studies - Safety data is monitored by an independent data safety monitoring board, which has not reported any modifications to the study [56] Question: Efficacy definitions for upcoming readouts - Efficacy is assessed through both current market standards and the potential for normal wakefulness during daytime hours [62][63] Question: Future business development and M&A strategy - The company is open to acquiring additional assets that fit its strategy and can add value to its development program [70][71] Question: Impact of Medicaid cuts on VIVITROL - The company is not currently seeing changes in federal funding for VIVITROL, with less than 5% of demand based on government funding [84] Question: Visual disturbances in Vibrance studies - All patients in Phase II programs receive visual exams, and the data safety monitoring board oversees safety across the studies [94]

Exhibit 99.1 Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 Alkermes plc Reports First Quarter 2025 Financial Results — First Quarter Revenues of $306.5 Million — — GAAP Net Income of $22.5 Million and Diluted GAAP Earnings per Share of $0.13 — — Company Reiterates 2025 Financial Expectations — DUBLIN, May 1, 2025 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the first quarter of 2025. "Our first quarter financial performance provid ...

Core Insights - Alkermes plc reported a total revenue of $306.5 million for Q1 2025, a decrease from $350.4 million in Q1 2024, indicating a year-over-year decline of approximately 12.5% [3][9] - The company achieved a GAAP net income of $22.5 million for Q1 2025, down from $36.8 million in Q1 2024, reflecting a decrease of about 38.8% [4][9] - Alkermes reiterated its financial expectations for 2025, maintaining confidence in its strategic objectives and market position [2][13] Financial Performance - Total proprietary net sales for Q1 2025 were $244.5 million, compared to $233.5 million in Q1 2024, representing an increase of approximately 4.3% [3][23] - Key product revenues included VIVITROL® at $101.0 million, ARISTADA® at $73.5 million, and LYBALVI® at $70.0 million, with LYBALVI® showing a significant growth of 23% year-over-year [3][10][6] - The company reported an adjusted EBITDA of $45.6 million for Q1 2025, down from $81.8 million in Q1 2024, indicating a decline of about 44.3% [4][24] Research and Development - Alkermes completed enrollment in the Vibrance-1 phase 2 study for ALKS 2680, an oral orexin 2 receptor agonist for narcolepsy type 1, with topline results expected in early Q3 2025 [2] - The company is also progressing with the Vibrance-2 and Vibrance-3 phase 2 studies, targeting narcolepsy type 2 and idiopathic hypersomnia, respectively [2] Balance Sheet - As of March 31, 2025, Alkermes reported cash, cash equivalents, and total investments of $916.2 million, an increase from $824.8 million at the end of 2024 [12][25] - Total assets stood at $2.08 billion, with total shareholders' equity of $1.51 billion, reflecting a solid financial position [25]

Core Insights - The survey conducted by The Harris Poll on behalf of Alkermes, Inc. reveals that the diagnosis of alcohol use disorder (AUD) is often prompted by negative consequences of alcohol consumption, and treatment can lead to significant positive changes in the lives of individuals with AUD [1][2][4] Group 1: Diagnosis and Treatment Insights - 47% of respondents were diagnosed with AUD following a hospital or emergency room visit due to symptoms or alcohol-related incidents [2] - One-third of respondents indicated personal concern about alcohol use (36%), healthcare provider visits related to symptoms (35%), and encouragement from loved ones (32%) as factors leading to their diagnosis [2] - 79% of respondents reported negative feelings upon diagnosis, including fear (38%), shame (33%), and embarrassment (32%) [2][3] Group 2: Treatment Engagement and Impact - 70% of respondents reported currently being treated for AUD, while 28% had been treated in the past but were not currently receiving treatment [6] - Among those treated, 50% were using prescription medication, 46% were in behavioral therapy, and 43% were involved in support group therapy [6] - Over half of the respondents indicated that treatment positively impacted their physical health (61%), overall quality of life (60%), and relationships with children (60%) [6] Group 3: Role of Healthcare Providers - 33% of respondents were diagnosed by an addiction specialist, and 26% by a primary care physician [6] - 80% of respondents discussed prescription medication for AUD with their healthcare provider, with 50% choosing their medication based on provider recommendations [6] - Only 28% of respondents were diagnosed through routine screenings during standard healthcare visits, highlighting a gap in proactive diagnosis [6]

DUBLIN, April 17, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Thursday, May 1, 2025 to discuss the company's first quarter financial results.The webcast player and accompanying slides may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. A replay of the webcast w ...