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Alkermes plc. SEC 10-Q Report

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Alkermes plc., a global biopharmaceutical company, has released its Form 10-Q report for the third quarter of 2025. The report highlights the company's financial performance, operational achievements, and strategic initiatives. Alkermes continues to focus on developing innovative medicines for the treatment of central nervous system (CNS) diseases and oncology, with a strong emphasis on research and development to drive future growth.

Financial Highlights

Total Revenues: $394.2 million, an increase of $16.0 million compared to the same period in 2024, primarily due to an increase in product sales, net.

Operating Income from Continuing Operations: $89.1 million, a decrease of $15.7 million compared to the same period in 2024, primarily due to increased research and development expenses and selling, general and administrative expenses.

Net Income from Continuing Operations: $82.8 million, a decrease of $10.0 million compared to the same period in 2024, reflecting higher total expenses despite increased revenues.

Net Income: $82.8 million, down from $92.4 million in the same period in 2024, due to increased expenses and lower manufacturing and royalty revenues.

Earnings Per Ordinary Share - Basic: $0.50, decreased from $0.57 in the same period in 2024.

Earnings Per Ordinary Share - Diluted: $0.49, decreased from $0.56 in the same period in 2024.

Business Highlights

Revenue Segments

The company's product sales, net, consist of sales of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI, primarily to wholesalers, specialty distributors, and pharmacies. VIVITROL sales increased by $7.4 million in the three months ended September 30, 2025, compared to the same period in 2024, while ARISTADA and ARISTADA INITIO sales increased by $13.4 million, and LYBALVI sales increased by $23.5 million.

Sales Units

The increase in product sales, gross during the three months ended September 30, 2025, was due to increases of 23% in LYBALVI units, 3% in ARISTADA/ARISTADA INITIO units, and 2% in VIVITROL units sold, along with a 3% price increase for each product effective January 1, 2025.

Manufacturing and Royalty Revenues

Manufacturing and royalty revenues decreased by $28.3 million in the three months ended September 30, 2025, compared to the same period in 2024, primarily due to the expiration of the royalty on U.S. net sales of INVEGA SUSTENNA in August 2024.

Research and Development Expenses

R&D expenses increased by $21.9 million in the three months ended September 30, 2025, compared to the same period in 2024, primarily due to increased spending on the development program for alixorexton, including the initiation of the Vibrance-3 phase 2 clinical study.

Future Outlook

The company announced a definitive transaction agreement to acquire Avadel Pharmaceuticals plc, with the acquisition expected to be completed in the first quarter of 2026, subject to customary conditions. The company expects to incur costs of approximately $15.0 million to $20.0 million in connection with the acquisition during the fourth quarter of 2025.

Product Development

Alixorexton, a novel, investigational, oral, selective orexin 2 receptor agonist, is in development for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. The company is proceeding with plans for a phase 3 program in narcolepsy following detailed safety and efficacy results from the Vibrance-1 study.

Legal Proceedings

The company is involved in several legal proceedings, including patent infringement lawsuits related to LYBALVI and VIVITROL, and an antitrust class action litigation related to VIVITROL. The company intends to vigorously defend its intellectual property in these matters.

SEC Filing: Alkermes plc. [ ALKS ] - 10-Q - Oct. 28, 2025