Financial Data and Key Metrics Changes - The company reported total revenues of $1.11 billion for 2022, a 24% year-over-year growth driven primarily by proprietary products [17] - GAAP net loss for the year was $158.3 million, compared to a loss of $48.2 million in the prior year, while non-GAAP net income was $57.9 million, down from $129.1 million in 2021 [18] - The company ended 2022 with approximately $740 million in cash and total investments, and a positive net cash position of approximately $447 million [26] Business Line Data and Key Metrics Changes - LYBALVI generated net sales of $96 million in its first full year, with fourth-quarter sales of $34.9 million, up 29% sequentially [8][20] - ARISTADA net sales for the fourth quarter were $79.2 million, reflecting a 7% year-over-year growth [13] - VIVITROL achieved net sales of $379.5 million for 2022, up 10% year-over-year, with fourth-quarter sales of $102 million [14][18] Market Data and Key Metrics Changes - Total prescriptions for LYBALVI in the fourth quarter were approximately 28,400, representing a 23% growth quarter-over-quarter [9] - The prescriber base for LYBALVI increased by approximately 27% since the end of Q3, with about 7,600 prescribers having written prescriptions [9] - The company expects LYBALVI net sales in 2023 to range from $180 million to $205 million, while VIVITROL is expected to generate $380 million to $410 million [12][29] Company Strategy and Development Direction - The company plans to focus on three key areas in 2023: expanding prescriber breadth, enhancing patient access, and building awareness through direct-to-consumer advertising [11][35] - The planned separation of the oncology business is expected to enhance the financial profile of the neuroscience business, allowing for a clearer investment thesis [17][47] - The company aims to achieve long-term profitability targets, increasing non-GAAP net income margin targets to 25% in 2024 and 30% in 2025 [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing launch of LYBALVI and its potential to drive significant revenue growth [36] - The company is optimistic about the orexin 2 receptor agonist program, with initial studies showing promising safety and tolerability profiles [38] - The separation of the oncology business is anticipated to unlock value and position both segments for growth [47] Other Important Information - The company recorded manufacturing and royalty revenues of $332 million for the year, down from $541.8 million in the prior year, primarily due to a decrease in royalties from long-acting INVEGA products [21][23] - Total operating expenses for 2022 were $1.25 billion, with R&D expenses reflecting focused investments in clinical programs [24][25] Q&A Session Summary Question: Can you discuss the balance between SG&A and R&D spend on the neuropsych business? - Management indicated that long-term margin targets depend on revenue growth and that investments in LYBALVI will continue to maximize opportunities [51] Question: On your long-term guide, how do you see LYBALVI's expectations evolving? - Management did not provide specific long-term expectations but emphasized that growth from proprietary products will drive profitability [55] Question: Can you clarify the dynamics of LYBALVI prescriptions? - Management noted that the growth in prescriptions is primarily driven by new prescribers, with a stable depth of prescribing [58] Question: What are the expectations for the orexin program's clinical trials? - Management confirmed that the current data is from single-ascending dose cohorts, with multiple ascending dose studies expected to start soon [61] Question: How will the oncology spin impact profitability targets? - The oncology spin is expected to reduce R&D costs significantly, aiding in achieving revised profitability targets [72]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35299 ALKERMES PUBLIC LIMITED COMPANY (Exact name of registrant as specified in its charter) Ireland 98-1007018 (State or other juri ...

A Clear Investment Thesis Richard Pops Chief Executive Officer 41st Annual J.P. Morgan Healthcare Conference January 2023 © 2023 Alkermes. All rights reserved. Forward-Looking Statements Certain statements set forth in this presentation constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations with respect to its current and future financial and operating per ...

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]

Alkermes plc. (NASDAQ:ALKS) Q2 2022 Earnings Conference Call July 27, 2022 8:00 AM ET Company Participants Sandra Coombs - SVP, IR & Corporate Affairs Iain Brown - CFO Todd Nichols - CCO Richard Pops - CEO Conference Call Participants Brandon Folkes - Cantor Fitzgerald Chris Shibutani - Goldman Sachs Umer Raffat - Evercore ISI Amy Li - Jefferies Paul Matteis - Stifel Marc Goodman - SVB Leerink Douglas Tsao - H.C. Wainwright Operator Greetings, and welcome to the Alkermes Second Quarter 2022 Earnings Call. M ...