Financial Performance - Net income from continuing operations for Q3 2025 was $82.8 million, down from $92.8 million in Q3 2024, representing a decrease of 10.8%[87] - Total revenues for Q3 2025 increased by $16.0 million compared to Q3 2024, primarily driven by an increase in product sales, net[88] - For the nine months ended September 30, 2025, net income from continuing operations decreased by $34.1 million, attributed to a $36.3 million decline in revenues, mainly from lower manufacturing and royalty revenues[89] - For the three months ended September 30, 2025, product sales, net, increased to $317.4 million, a 16.2% increase from $273.0 million in the same period of 2024[113] - The gross product sales for the nine months ended September 30, 2025, reached $1,631.1 million, compared to $1,543.8 million in 2024, reflecting a 5.7% increase[113] Product Sales and Revenue - LYBALVI units sold increased by 19% during the nine months ended September 30, 2025, contributing significantly to the overall sales growth[114] - Medicaid rebates decreased by approximately $7.6 million for VIVITROL and $4.9 million for ARISTADA/ARISTADA INITIO during the three months ended September 30, 2025, compared to the same period in 2024[115] - Manufacturing and royalty revenues for the three months ended September 30, 2025, were $76.8 million, down from $105.1 million in 2024, a decrease of 27%[117] - The increase in RISPERDAL CONSTA revenue during the nine months ended September 30, 2025, was due to an $8.2 million increase in manufacturing revenue[118] - The company expects continued lower royalty revenues from long-acting INVEGA products due to the expiration of royalties on net sales in August 2024[117] Research and Development - The company is focused on R&D for innovative medicines in neuroscience, with significant resources allocated to preclinical work and clinical studies[111] - Research and development expenses include both external and internal costs, with external expenses tracked for each development program[121] - The company plans to initiate a phase 3 program in narcolepsy following the completion of phase 2 studies, including the Vibrance-1 study results announced in September 2025[112] - Total external R&D expenses increased by 66.2% to $43.2 million for the three months ended September 30, 2025, compared to $26.0 million in the same period of 2024[122] - Alixorexton development expenses rose to $25.8 million for the three months ended September 30, 2025, up from $11.9 million in 2024, reflecting increased spending on clinical studies[123] - Internal R&D expenses increased by 11.6% to $38.5 million for the three months ended September 30, 2025, compared to $33.8 million in 2024[125] Expenses and Cash Flow - Selling and marketing expenses rose by 14.0% to $115.6 million for the three months ended September 30, 2025, compared to $102.1 million in 2024[125] - General and administrative expenses increased by 16.5% to $56.2 million for the three months ended September 30, 2025, compared to $48.2 million in 2024[126] - Cash and cash equivalents totaled $616.4 million as of September 30, 2025, up from $291.1 million at the beginning of the period[130] - Cash generated from operating activities was $350.6 million for the nine months ended September 30, 2025, compared to $248.7 million in 2024[131] - Operating cash flow for the nine months ended September 30, 2025, was $192.3 million, down from $220.6 million in the same period of 2024, reflecting a decrease of approximately 12%[138][139] Acquisition and Financing - The company announced a proposed acquisition of Avadel for up to $20.00 per share, expected to complete in Q1 2026, with anticipated costs of $15.0 million to $20.0 million related to the acquisition[91] - The company entered into a Bridge Credit Agreement for up to $1.2 billion to finance a proposed acquisition, with $700 million placed in escrow for this purpose[134] Shareholder Returns and Investments - Share-based compensation for the nine months ended September 30, 2025, was $72.4 million, compared to $75.9 million in 2024, indicating a decrease of about 4.6%[138][139] - Cash flows used in investing activities for the nine months ended September 30, 2025, included $40.4 million for property, plant, and equipment purchases, significantly lower than $23.7 million in 2024[140] - Cash flows provided by financing activities for the nine months ended September 30, 2025, included $32.2 million from employee stock option exercises, compared to $19.4 million in 2024, representing a 65% increase[141] - The company reported changes in working capital of $27.7 million for the nine months ended September 30, 2025, compared to a negative change of $105.1 million in 2024[138][139] - The company repurchased $200.0 million of ordinary shares under the Repurchase Program during the nine months ended September 30, 2024[141] Market Risk and Currency Exposure - The company has not anticipated any near-term changes in market risk exposures since December 31, 2024, indicating stability in its investment strategy[145][146] - Non-U.S. currency exchange risk primarily relates to royalty revenues, with no material change in sensitivity assessment since December 31, 2024[146] - The company continues to focus on preserving capital and generating investment income through regular reviews of its marketable securities holdings[145]

Financial Data and Key Metrics Changes - For Q3 2025, total revenues reached $394.2 million, with proprietary products generating net sales of $317.4 million, reflecting a 16% year-over-year growth [11][12] - GAAP net income was $82.8 million, with EBITDA of $96.9 million and adjusted EBITDA of $121.5 million for the quarter [13] - The company raised its full-year 2025 guidance to total revenues of $1.43 billion to $1.49 billion, GAAP net income of $230 million to $250 million, and adjusted EBITDA of $365 million to $385 million [14] Business Line Data and Key Metrics Changes - Vivitrol net sales for Q3 were $121.1 million, driven by growth in the alcohol dependence indication market, with full-year expectations now at $460 million to $470 million [18] - Aristada net sales were $98.1 million for Q3, with full-year expectations raised to $360 million to $370 million [19] - Lybalvi net sales grew 32% year-over-year to $98.2 million, with full-year expectations now at $340 million to $350 million [19] Market Data and Key Metrics Changes - The company experienced strong underlying demand across its proprietary products, with gross-to-net favorability primarily related to Medicaid utilization rates [11][12] - The expansion of the psychiatry sales force contributed to increased prescriber breadth and strong new-to-brand prescriptions [18][19] Company Strategy and Development Direction - The proposed acquisition of Avadel Pharmaceuticals is expected to diversify the commercial portfolio and strengthen profitability, particularly in the sleep medicine market [6][8] - The company is advancing its portfolio of orexin-2 receptor agonists, with a focus on Elixerextant for narcolepsy and idiopathic hypersomnia [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum of the business and the strong commercial performance through the first nine months of the year [5][14] - The company is positioned to deliver long-term value for shareholders while advancing innovative medicines [15][25] Other Important Information - The company entered Q3 with $1.14 billion in cash and total investments, planning to use cash and bank debt for the acquisition of Avadel [14] - Management highlighted the importance of maintaining a disciplined contracting strategy consistent with the value of their medicines [21] Q&A Session Summary Question: Can you talk about Lybalvi's performance and gross-to-net expectations? - Management noted strong performance driven by an expanded psychiatry footprint and increased call volume, with gross-to-net lower due to deductible resets and lower copay utilization [28][30] Question: What are the expectations for NT2 Elixerextant data and FDA next steps? - Management expects to request an end-of-phase meeting with the FDA after receiving NT2 data in November, with plans to initiate the phase three program early next year [34][35] Question: Can you confirm details on the top-line release for Vibrance II data? - Management indicated that top-line data will be released soon, with a focus on safety and efficacy across various doses [43][45] Question: How do you view the potential impact of ACA subsidy lapses on commercial business? - Management believes there is a strong political reason to maintain ACA subsidies, particularly for patients with serious mental illness and addiction [86][88]

Financial Data and Key Metrics Changes - Alkermes reported total revenues of $394.2 million for Q3 2025, driven by proprietary products generating net sales of $317.4 million, reflecting a 16% year-over-year growth [9][10] - The company raised its full-year 2025 guidance to total revenues of $1.43 to $1.49 billion, GAAP net income of $230 to $250 million, EBITDA of $270 to $290 million, and adjusted EBITDA of $365 to $385 million [11] - GAAP net income for Q3 was $82.8 million, with EBITDA of $96.9 million and adjusted EBITDA of $121.5 million [10] Business Line Data and Key Metrics Changes - Vivitrol net sales for Q3 were $121.1 million, with full-year expectations now in the range of $460 to $470 million [16] - Aristada net sales for Q3 were $98.1 million, with full-year expectations raised to $360 to $370 million [17] - Lybalvi net sales grew 32% year-over-year to $98.2 million, with full-year expectations now in the range of $340 to $350 million [17] Market Data and Key Metrics Changes - The company experienced strong underlying demand across its proprietary product portfolio, with gross-to-net favorability primarily related to Medicaid utilization rates [9][10] - The expansion of the psychiatry sales force earlier in the year significantly increased the frequency of call volume for high-priority prescriber targets [16] Company Strategy and Development Direction - Alkermes announced a proposed acquisition of Avadel Pharmaceuticals, which is expected to diversify its commercial portfolio and strengthen profitability [4][5] - The acquisition will accelerate entry into the sleep medicine market and support the development of Elixerextant, an orexin-2 receptor agonist [5][6] - The company is focused on advancing its pipeline of orexin-2 receptor agonists, with plans to initiate a global phase 3 program for Elixerextant early next year [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum of the business and the strong commercial execution observed in Q3 [4][8] - The company is operating from a position of financial strength and is well-positioned to deliver long-term value for shareholders [12][22] - Management highlighted the importance of maintaining a disciplined contracting strategy consistent with the significant value of their medicines [18] Other Important Information - Alkermes entered Q3 with $1.14 billion in cash and total investments, planning to use cash and bank debt to finance the acquisition of Avadel [11] - The company is committed to neuroscience and aims to support a diversified development strategy in sleep disorders [6] Q&A Session Summary Question: Can you talk about Lybalvi's performance and gross-to-net expectations? - Management noted strong performance driven by an expanded psychiatry footprint and increased call volume, with gross-to-net lower due to deductible resets and lower copay utilization [25][27] Question: What are the expectations for the NT2 Elixerextant data and Vivitrol heading into Q4? - Management expects data from the NT2 study in November, which will inform the next steps with the FDA, while Vivitrol is expected to continue strong AD growth in Q4 [30][32] Question: Can you confirm details about the top-line release for Vibrance II data? - Management indicated that top-line data will be released soon, with a focus on safety and efficacy across various parameters to inform phase 3 design [39][41] Question: What are the expectations for ocular monitoring in phase 3 programs? - Management stated that while there were mild ocular events in previous studies, it is too early to determine if monitoring will be necessary in phase 3 [48] Question: How does the company view the potential impact of ACA subsidy lapses? - Management expressed that there is a strong political reason to maintain ACA subsidies, particularly for patients with serious mental illness and addiction [75][77]

Third Quarter 2025 Financial Results & Business Update October 28, 2025 Forward-Looking Statements and Non-GAAP Financial Information 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: Alkermes plc's (the "Company") expectations with respect to its current and future financial, commercial and operating performance, business plans ...

Financial Performance - Alkermes PLC reported a total revenue of $250 million for Q3 2023, representing a 15% increase year-over-year[1] - The company achieved a net income of $30 million, compared to a net loss of $5 million in the same quarter last year, indicating a significant turnaround[1] - Alkermes' product sales increased by 20%, driven by strong demand for its leading drug, Aristada, which accounted for $150 million in sales[1] - The company reported a leverage ratio of 3.5x, indicating a stable financial position and capacity for future investments[1] - The company reported a significant increase in revenue, reaching $1.5 billion, representing a 20% year-over-year growth[1] Future Guidance - Alkermes expects revenue for Q4 2023 to be in the range of $260 million to $280 million, reflecting continued growth in product demand[1] - The company provided guidance for the next quarter, projecting revenue between $1.6 billion and $1.7 billion, which reflects a growth rate of 10-13%[3] Research and Development - The company is investing $50 million in R&D for new product development, focusing on innovative therapies for mental health disorders[1] - The company is investing $50 million in research and development for new technologies aimed at enhancing user experience[5] Market Expansion - Alkermes plans to expand its market presence in Europe, targeting a 25% increase in sales in the region by the end of 2024[1] - Market expansion efforts include entering three new countries, which are projected to add 1 million new users by the end of the year[6] Strategic Acquisitions - The company is exploring potential acquisitions to enhance its product portfolio and market reach, with a budget of $100 million allocated for this purpose[1] - The company completed a strategic acquisition for $300 million, expected to enhance its product offerings and market share[7] Marketing Strategies - Alkermes has implemented a new digital marketing strategy aimed at increasing patient engagement and awareness, projected to boost sales by 15% in the next fiscal year[1] - The company plans to increase its marketing budget by 30% to support new product launches and market penetration[9] - The company plans to implement a new marketing strategy with a budget of $20 million to boost brand awareness[10] Operational Efficiency - The company reported a 10% increase in the number of patients treated with its products, reaching a total of 100,000 patients[1] - Cost reduction strategies implemented have resulted in a 15% decrease in operational expenses, improving overall profitability[8] - Operating margin improved to 30%, up from 25% in the previous year, reflecting better cost management[8] - Customer retention rate increased to 85%, up from 80% last quarter, indicating improved customer satisfaction[9]

Core Insights - Alkermes plc reported strong financial results for Q3 2025, with revenues of $394.2 million, a 4% increase from $378.1 million in Q3 2024 [3][4] - The company achieved a GAAP net income of $82.8 million, with diluted earnings per share of $0.49 [3][20] - Alkermes raised its financial expectations for 2025, indicating positive momentum in its business operations [2][7] Financial Performance - Total revenues for the nine months ended September 30, 2025, were $1,091.4 million, compared to $1,127.6 million for the same period in 2024 [3] - Proprietary net sales for Q3 2025 were $317.4 million, up from $273.0 million in Q3 2024, marking a 16% increase [3][5] - Key product sales included VIVITROL at $121.1 million (up 7%), ARISTADA at $98.1 million (up 16%), and LYBALVI at $98.2 million (up 32%) compared to Q3 2024 [3][5] Profitability Metrics - GAAP net income from continuing operations was $82.8 million for Q3 2025, down from $92.8 million in Q3 2024 [3][20] - Adjusted EBITDA for Q3 2025 was $121.5 million, compared to $134.3 million in Q3 2024 [3][21] - The company reported a total operating income of $89.1 million for Q3 2025, down from $104.8 million in Q3 2024 [3][20] Research and Development - Alkermes advanced its development pipeline, particularly in the orexin 2 receptor agonist program, with positive data from the Vibrance-1 study for narcolepsy type 1 [2] - The company plans to initiate its phase 3 clinical program for alixorexton in early 2026, which is expected to be a significant growth driver [2] Updated Financial Guidance - Alkermes updated its 2025 financial expectations, raising total revenue guidance to $1,430 – $1,490 million from the previous range of $1,340 – $1,430 million [7][8] - The updated expectations for VIVITROL net sales increased to $460 – $470 million, ARISTADA net sales to $360 – $370 million, and LYBALVI net sales to $340 – $350 million [8]

Group 1 - Avadel Pharmaceuticals (AVDL) has accepted a buyout offer from Alkermes plc (ALKS) following the settlement of litigation with Jazz Pharmaceuticals (JAZZ) [1] - This acquisition is part of a series of notable acquisitions in the biotech sector [1] Group 2 - The Biotech Forum, led by Bret, offers a model portfolio of 12-20 high upside biotech stocks, along with live chat discussions and weekly research updates [1]

Core Insights - Alkermes plc (ALKS) has entered into a definitive agreement to acquire Avadel Pharmaceuticals (AVDL) for up to $20.00 per share in cash, totaling approximately $2.1 billion [1][7] - The acquisition is expected to close in the first quarter of 2026, pending customary closing conditions [1] - The deal represents a 38% premium to Avadel's average trading price over the past three months and a 12% premium to its closing price on October 21, 2025 [2] Acquisition Details - Alkermes will pay $18.50 per share in cash at closing, with Avadel shareholders also receiving a contingent value right (CVR) worth up to an additional $1.50 per share, contingent on FDA approval of Lumryz by the end of 2028 [4] - The acquisition will be funded through Alkermes' existing cash reserves and new debt issuance, with cash and cash equivalents of $1.05 billion as of June 30, 2025 [5] Product and Market Impact - Avadel's Lumryz is the first and only once-at-bedtime oxybate approved for treating narcolepsy, with sales of $120.6 million in the first half of 2025, reflecting a 76% year-over-year increase [8] - Lumryz's projected net revenues for 2025 are estimated to be between $265 million and $275 million, indicating strong growth potential [8] - The acquisition allows Alkermes to enter the high-growth sleep medicine market and complements its existing pipeline, particularly its orexin program [9][7] Strategic Fit - The integration of Avadel's operations is expected to generate cost synergies and enhance operational efficiency as Alkermes prepares for the potential launch of its lead orexin program, alixorexton [12] - Alkermes is also developing alixorexton for narcolepsy and idiopathic hypersomnia, with ongoing clinical trials expected to yield data in 2025 and 2026 [10][11]

Core Insights - Alkermes has agreed to acquire Avadel Pharmaceuticals for up to $20 per share, valuing Avadel at $2.1 billion, which will expedite Alkermes' entry into the sleep medicine sector [1][2] - The acquisition is expected to be immediately accretive and represents a strategic opportunity to enhance Alkermes' operational infrastructure and rare disease capabilities [2][4] - The transaction has received approval from the boards of both companies and is set to conclude in the first quarter of 2026 [1] Company Strategy - Alkermes CEO Richard Pops emphasized that this acquisition is a pivotal step in the company's strategic evolution, allowing for accelerated entry into the sleep medicine market [3] - The acquisition will enhance Alkermes' revenue growth profile and is expected to reinforce long-term value for shareholders [4] - The combined organization will leverage its financial capabilities to develop Alkermes' orexin-2 receptor agonists portfolio, which includes ALKS 4510 and ALKS 7290, currently in Phase I trials [4] Product Details - Avadel's FDA-approved therapy, Lumryz (sodium oxybate), is used to treat cataplexy or excessive daytime sleepiness in narcolepsy patients aged seven and older [2] - The acquisition will allow Alkermes to build on Avadel's innovative portfolio and commercial capabilities, providing a strong foundation for growth in the sleep medicine therapeutic area [4]

Core Viewpoint - Alkermes plc is making a strategic acquisition of Avadel Pharmaceuticals valued at up to $2.1 billion to enhance its position in the sleep medicine market, particularly focusing on central nervous system disorders [2][5]. Group 1: Acquisition Details - The acquisition will leverage Avadel's drug Lumryz, which treats excessive daytime sleepiness in narcolepsy patients, and aims to unlock the potential of Alkermes' late-stage pipeline [2]. - The deal values Avadel's stock at $18.50 per share, with an additional contingent value right (CVR) of $1.50 per share, contingent on FDA approval of Lumryz for idiopathic hypersomnia by the end of 2028 [3][5]. Group 2: Financial Aspects - Alkermes plans to finance the acquisition using its cash reserves and by issuing new debt [3][5]. - At the time of the acquisition announcement, Alkermes' stock price was $31.84, and it experienced a decline following the news, while Avadel's shares increased [3]. Group 3: Stock Performance - On the trading day of the announcement, Alkermes' stock was priced at $31.74, reflecting a 0.93% increase with a trading volume of 2,154,100 shares [4]. - Over the past year, Alkermes' stock has fluctuated between a high of $36.45 and a low of $25.17, with a current market capitalization of approximately $5.24 billion [4].