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]

Q2 2025 Financial Performance - Total revenue decreased to $390.7 million from $399.1 million in Q2 2024[7] - GAAP net income decreased to $87.1 million from $91.4 million in Q2 2024[7] - GAAP earnings per share (diluted) decreased to $0.52 from $0.53 in Q2 2024[7] - Adjusted EBITDA decreased to $126.5 million from $135.3 million in Q2 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, 12] Q2 2025 Revenue Breakdown - Total proprietary net sales increased to $307.2 million from $269.3 million in Q2 2024[12] - VIVITROL® net sales were $121.7 million, compared to $111.9 million in Q2 2024[12] - ARISTADA® net sales were $101.3 million, compared to $86.0 million in Q2 2024[12] - LYBALVI® net sales were $84.3 million, compared to $71.4 million in Q2 2024[12] - Manufacturing & Royalty Revenue decreased to $83.4 million from $129.9 million in Q2 2024[12] 2025 Financial Expectations - Total revenues are expected to be between $1340 million and $1430 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 be between $440 million and $460 million[16] - ARISTADA® net sales are expected to be between $335 million and $355 million[16] - LYBALVI® net sales are expected to be between $320 million and $340 million[16]

[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]

Company Overview - Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines in neuroscience [3] - The company has a portfolio of proprietary commercial products targeting alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder [3] - Alkermes is headquartered in Ireland, with additional offices in Massachusetts and a manufacturing facility in Ohio [3] Upcoming Financial Event - Alkermes will host a conference call and webcast presentation on July 29, 2025, at 8:00 a.m. ET to discuss its second quarter financial results [1] - The conference call can be accessed by U.S. callers at +1 877 407 2988 and international callers at +1 201 389 0923 [2] - A replay of the webcast will be available approximately two hours after the event on Alkermes' website [2]

Core Viewpoint - Alkermes (ALKS) shows potential for significant upside, with a mean price target of $40.33 indicating a 33.2% increase from the current price of $30.28 [1] Price Targets and Estimates - The mean estimate consists of 15 short-term price targets with a standard deviation of $6.84, indicating variability among analysts [2] - The lowest estimate is $27.00, suggesting a 10.8% decline, while the highest estimate is $52.00, indicating a potential surge of 71.7% [2] - A low standard deviation among price targets suggests a high degree of agreement among analysts regarding the stock's price movement [9] Earnings Estimates - Analysts have shown increasing optimism about Alkermes' earnings prospects, with a positive trend in earnings estimate revisions [11] - The Zacks Consensus Estimate for the current year has increased by 1% over the past month, with one estimate rising and no negative revisions [12] - Alkermes holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [13] Analyst Behavior and Price Target Reliability - Analysts often set overly optimistic price targets due to business incentives, which can lead to inflated estimates [8] - While price targets can provide some guidance, they should be approached with skepticism, as they may not accurately reflect future stock movements [10]