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Alkermes(ALKS) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In 2024, the company achieved over 1.5billioninrevenue,primarilyfromitsproprietarycommercialportfolio,resultinginmorethan1.5 billion in revenue, primarily from its proprietary commercial portfolio, resulting in more than 450 million of EBITDA from continuing operations [9][15] - The company ended the year with 825millionincashandnodebt,havingrepurchasedapproximately8millionshares[10][23]For2025,thecompanyexpectstogenerateover825 million in cash and no debt, having repurchased approximately 8 million shares [10][23] - For 2025, the company expects to generate over 200 million of EBITDA and total revenues in the range of 1.34billionto1.34 billion to 1.43 billion [10][25] Business Line Data and Key Metrics Changes - VIVITROL net sales reached 457.3million,reflectinga14457.3 million, reflecting a 14% year-over-year growth, while ARISTADA net sales increased 6% to 346.2 million [17][36] - LYBALVI saw a significant increase in net sales by 46% year-over-year, totaling 280million[17][40]Theproprietaryproductportfoliogrew18280 million [17][40] - The proprietary product portfolio grew 18% year-over-year, generating over 1 billion in net sales [16][34] Market Data and Key Metrics Changes - The company anticipates flat to modest growth for mature products like VIVITROL and ARISTADA in 2025, while LYBALVI is expected to grow by approximately 25% year-over-year [11][40] - Manufacturing and royalty revenues are projected to decrease by approximately $215 million in 2025 due to the expiration of certain royalties and the conclusion of legacy manufacturing revenues [25] Company Strategy and Development Direction - The company aims to become a highly profitable, fully integrated neuroscience biopharmaceutical company, focusing on commercial execution and pipeline progress [7][8] - Key value drivers for 2025 include data readouts for the lead development candidate, ALKS 2680, which is in Phase 2 studies for narcolepsy [12][44] - The company is transitioning to an adjusted EBITDA metric to better capture the dynamics of its underlying business [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing safety monitoring of the orexin program and the potential for ALKS 2680 to differentiate itself in the market [60][91] - The company is optimistic about the competitive positioning of its products and the overall growth in the neuroscience market [43][78] Other Important Information - The company completed the sale of its manufacturing business in Ireland, which is expected to enhance gross margins going forward [16] - The company plans to expand its sales force by approximately 80 representatives to enhance competitive positioning in the psychiatry market [72][41] Q&A Session Summary Question: Inquiry about the Orexin program and monitoring of adverse events - Management confirmed ongoing safety monitoring through a Data Safety Monitoring Board (DSMB) and expressed confidence in retention rates during the study [60][61] Question: Competitive dynamics for LYBALVI and ARISTADA - Management acknowledged the competitive landscape but emphasized that market growth could benefit their portfolio, with plans to expand the sales force to maintain a strong market presence [68][70] Question: Timing of pivotal studies for ALKS 2680 - Management indicated that they hope to initiate Phase 3 studies quickly after completing Phase 2 and having discussions with the FDA [138] Question: Sources of funding for VIVITROL and Medicaid implications - Management noted that approximately 50% of VIVITROL's business comes from Medicaid, and they are prepared to advocate for access to medications amid potential Medicaid reforms [126][130]