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]