Financial Data and Key Metrics Changes - Total revenues for Q3 2022 were $252.4 million, driven primarily by proprietary commercial products [20] - GAAP net loss for the quarter was $64 million, while non-GAAP net income was $3.5 million [25] - The company ended the quarter with approximately $747 million in cash and a positive net cash position of close to $453 million [26] Business Line Data and Key Metrics Changes - VIVITROL net sales were $96.5 million, reflecting a 9% year-over-year growth [20][35] - ARISTADA product family generated net sales of $75.7 million, a 10% increase year-over-year [21] - LYBALVI net sales increased 35% sequentially to $27.1 million, driven by strong underlying demand growth of 36% [22] - Manufacturing and Royalty revenues were $52.9 million, a significant decrease from $136.3 million in the prior year due to J&J's termination of royalties [23] Market Data and Key Metrics Changes - The company expects total revenues for 2022 to be in the range of $1.07 billion to $1.12 billion, reflecting an increase due to improved expectations for LYBALVI [27] - The oncology business is expected to attract its own capital to expand its program, particularly with the potential of nemvaleukin [48] Company Strategy and Development Direction - The company plans to explore separating its oncology and neuroscience businesses, potentially spinning off the oncology business into an independent publicly traded company [8][11] - The separation is expected to enhance strategic focus for each business and simplify capital allocation decision-making [12][19] - The neuroscience business aims to build on its heritage of innovation and focus on significant unmet needs within the field [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term value of LYBALVI, which supports the commercial and administrative side of the business [41] - The impact of the Inflation Reduction Act is seen as a catalyst for the oncology business, making biologic medicines more valuable [16] - The company anticipates completing the separation in the second half of 2023, with further details to be provided later [17] Other Important Information - The company is focused on unlocking shareholder value and positioning both the neuroscience and oncology businesses for growth and success [28] - The strong performance of LYBALVI is expected to drive enhanced profitability for the neuroscience business [19] Q&A Session Summary Question: What can be inferred from the spin announcement and confidence in LYBALVI? - The decision to spin was based on growing confidence in LYBALVI's long-term value, which supports the commercial side of the business [41] Question: When should investors expect a DSMB look into ARISTADA 6 and 7 in 2023? - The timing of the spin is fortunate as it will allow for enrollment in ARISTADA 6 and 7 until the spin is complete, providing precise understandings about readouts and interim looks [43] Question: How does the company envision the profile of the stand-alone neuroscience business? - The stand-alone neuroscience business is expected to have enhanced profitability driven by synergies from multiple products and growth of LYBALVI [48] Question: What is the long-term outlook for VIVITROL's growth? - Long-term growth for VIVITROL is expected to be driven by adoption within the alcohol dependence market, which represents a significant opportunity [65] Question: What are the funding requirements for the oncology business post-spin? - The oncology business will be funded within the context of the combined company until the second half of next year, with insights into funding requirements to be determined at that time [72]

Financial Data and Key Metrics Changes - For Q1 2022, total revenues reached $278.5 million, reflecting a 41% year-over-year growth driven by VIVITROL, ARISTADA, and the launch of LYBALVI [7][14] - GAAP net loss for the quarter was $35.9 million, while non-GAAP net income was $19.6 million [14] - The company ended the quarter with approximately $759 million in cash and investments, and total debt of approximately $295 million, resulting in a net cash position of close to $464 million [14] Business Line Data and Key Metrics Changes - VIVITROL net sales were $84.9 million, a 14% increase year-over-year, primarily due to a 7% increase in units sold [8] - ARISTADA generated net sales of $72.5 million, a 31% increase year-over-year, driven by 27% volume growth [8] - LYBALVI recorded net sales of $13.9 million in its first full quarter, exceeding initial expectations of $8 million to $10 million [9] - Manufacturing and royalty revenues decreased to $105.2 million from $119.8 million in the prior year, primarily due to a partial termination of a license agreement with J&J [11] Market Data and Key Metrics Changes - Revenues from VUMERITY increased 128% year-over-year to $30.6 million [11] - The company noted a favorable payer access environment for LYBALVI, with initial access decisions aligning with other branded oral agents [21][39] Company Strategy and Development Direction - The company is focused on executing its strategic priorities, particularly the launch of LYBALVI, which is expected to drive growth and profitability [26][28] - The management emphasized the importance of leveraging existing commercial infrastructure to support the launch of LYBALVI and advance oncology and neuroscience pipeline candidates [14][28] - The company is committed to enforcing its contractual rights regarding royalties and has initiated arbitration proceedings with J&J over a license agreement dispute [11][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing momentum across the company and reiterated financial guidance for full-year 2022 [7][14] - The management highlighted the strong early uptake of LYBALVI and the positive feedback from healthcare providers regarding its differentiated features [27][64] - The company remains optimistic about the growth potential of its proprietary product portfolio, particularly in the context of increasing patient needs and prescriber awareness [24][25] Other Important Information - Total operating expenses for Q1 were $305.1 million, up from $267.9 million in the prior year, driven by higher sales and marketing expenses [12] - The company expects gross to net adjustments for LYBALVI to be dynamic during its first year of launch, influenced by payer mix [10][44] Q&A Session Summary Question: Can you discuss the dynamics of LYBALVI and the switching of patients? - Management noted that approximately 50% of switches to LYBALVI are from olanzapine, with broad utility observed in the market [38][39] Question: What are the expectations for LYBALVI's sales in the upcoming quarters? - Management indicated that while LYBALVI is tracking well, they prefer to wait for Q2 results before updating guidance [42][59] Question: How does the gross to net ratio for LYBALVI compare to expectations? - The gross to net ratio for LYBALVI was 27% in Q1, with expectations for it to be dynamic throughout the year [44][46] Question: What is the timeline for the arbitration with J&J? - The arbitration process is expected to take at least six months, but the timeline can vary [73] Question: How is the market responding to LYBALVI in terms of weight gain concerns? - Feedback from healthcare providers indicates a positive perception of LYBALVI's efficacy and weight mitigation properties [62][64]

Alkermes plc. (NASDAQ:ALKS) Q4 2021 Earnings Conference Call February 16, 2022 8:00 AM ET Company Participants Sandra Coombs - SVP of IR and Corporate Affairs Richard Pops - Chairman & CEO Iain Brown - SVP & CFO Todd Nichols - SVP & CCO Conference Call Participants Brandon Folkes - Cantor Fitzgerald Vamil Divan - Mizuho Securities Akash Tiwari - Jeffries Umer Raffat - Evercore ISI Jason Gerberry - Bank of America Operator Greetings, and welcome to the Alkermes Fourth Quarter 2021 Earnings Call. My name is R ...