Alkermes(US:ALKS)2022-04-27 16:54Financial 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]