Alkermes(ALKS) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q3 2023, total revenues reached $380.9 million, up from$252.4 million year-over-year, reflecting a 51% increase [7] - GAAP net income was $47.8 million, while non-GAAP net income was$109.5 million for the quarter [10] - The company ended the quarter with approximately $996 million in cash and total investments, and total debt outstanding of approximately$291 million [10] Business Line Data and Key Metrics Changes - VIVITROL net sales were $99.3 million, reflecting a 3$81.8 million, primarily due to underlying demand [7][16] - LYBALVI net sales for the quarter were $50.7 million, up 8$149.1 million, compared to $52.9 million in the same period last year, driven by long-acting INVEGA products [8] - Revenues from VUMERITY were$34.6 million, up from $26.3 million year-over-year [9] Company Strategy and Development Direction - The company plans to separate its oncology business into Mural Oncology, which is expected to enhance profitability and focus on neuroscience [11][37] - Post-separation, Alkermes aims to be a pure play neuroscience company with a strong balance sheet and a focus on strategic priorities, including the ALKS 2680 development program [11][38] - The company is committed to disciplined expense management while investing in growth opportunities [11][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for enhanced profitability following the favorable outcomes of recent legal matters and the upcoming separation of the oncology business [6][10] - The company reiterated its financial expectations for 2023, reflecting combined neuroscience and oncology business performance [10] Other Important Information - Initial clinical data for ALKS 2680, a novel orexin 2 receptor agonist for narcolepsy, was presented, showing promising safety and efficacy profiles [19][33] - The company is focused on executing brand strategies for its proprietary products and driving net sales expectations for 2023 [18] Q&A Session Summary Question: How will long-term durability be factored into dosing for the orexin program? - Management indicated that they will model appropriate doses for Phase 2 based on observed dose response and safety profiles [41][42] Question: What is the plan for idiopathic hypersomnia (IH) development? - The company is collecting data on IH patients and will inform appropriate doses for Phase 2 based on these data [45][47] Question: Can you comment on the commercial organization as a leverageable asset? - Management confirmed that the established commercial infrastructure can be leveraged for additional products, indicating openness to acquiring market-ready assets [48] Question: What are the safety concerns regarding blood pressure increases observed in patients? - Management noted that only transient increases in blood pressure were observed, with no significant safety signals identified [67] Question: What are the expectations for LYBALVI trends into next year? - Management expressed confidence in LYBALVI's growth prospects, citing expanding prescriber breadth and ongoing direct-to-consumer campaigns [55]