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]

Summary of Alkermes (ALKS) FY Conference Call - June 09, 2025 Company Overview - Alkermes has evolved from a narrow focus on neuroscience to a broader drug delivery company, now generating a billion-dollar top line revenue driven by proprietary products [3][4][5] - The company aims to create new molecules that address unmet medical needs, particularly in the neuroscience space related to the sleep-wake cycle and circadian rhythm [4][5] Core Business and Pipeline - The current focus is on the REXN portfolio, particularly the orexin opportunity, which is seen as a new frontier in the field [6][7] - The company has a strong technical capability in chemistry, essential for developing complex molecules in the orexin space [5][6] - The commercial business is profitable and funds the pipeline, with expectations for growth and expansion over time [5][6] Clinical Trials and Data - Phase 1b study results showed a clear dose-dependent increase in maintenance of wakefulness in narcolepsy type 1 (NT1) patients, with no discontinuations due to adverse events (AEs) [11][12][32] - Phase 2 studies (Vibrance 1 and 2) are expected to provide further insights into tolerability and efficacy across different doses and patient populations [14][15][18] - The primary endpoints for the Vibrance studies include maintenance of wakefulness test (MWT), cataplexy rates, and sleepiness scales [26][48] Market Opportunity - The prevalence of NT1, NT2, and idiopathic hypersomnia (IH) patients is significant, yet only a fraction are currently treated, indicating a large market opportunity for orexin agonists [48][49] - The company anticipates deep penetration in the NT1 market due to its disease-modifying properties, while NT2 and IH may see varying levels of uptake based on patient needs and drug costs [49][50] - The potential for combination therapy with existing treatments is still under evaluation, with the expectation that orexin agonists could become frontline therapies for NT1 [56][58] Commercial Strategy - Alkermes plans to commercialize the orexin agonist globally, with a focus on maintaining high pricing reflective of its disease-modifying capabilities [66][67] - The company expects a high percentage of commercial payers (around 80%) for NT1, NT2, and IH patients, contrasting with its existing portfolio which is largely Medicaid and Medicare [70][71] - The commercial portfolio is performing well, with growth expected from existing products like Livaldi, ARISTADA, and VIVITROL [72][74] Conclusion - Alkermes is positioned to capitalize on the growing demand for innovative treatments in the sleep disorder market, with a strong pipeline and commercial strategy aimed at addressing significant unmet needs in NT1, NT2, and IH patients [48][49][72]

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]

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]