Accessibility StatementSkip Navigation "The alixorexton data from Vibrance-2 are the first demonstration in a large, randomized phase 2 study that an orexin 2 receptor agonist can drive clinically meaningful improvements in wakefulness and excessive daytime sleepiness in patients without known orexin deficiency, with a generally well tolerated profile. These data are exciting and represent an important breakthrough in advancing a potential new treatment option for patients living with narcolepsy type 2," sa ...

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]

Core Insights - Alkermes plc is set to present detailed results from its Vibrance-1 phase 2 study on alixorexton for narcolepsy type 1 at the World Sleep Congress in Singapore from September 5-10, 2025, and during an investor webcast on September 8, 2025 [1][2][7] Company Overview - Alkermes plc is a mid-cap global biopharmaceutical company focused on developing innovative medicines in neuroscience, with a portfolio addressing various neurological disorders including narcolepsy and idiopathic hypersomnia [10] Study Details - The Vibrance-1 study is a phase 2, randomized, double-blind, placebo-controlled trial involving 92 participants, evaluating the safety and efficacy of alixorexton in adults with narcolepsy type 1 [8] - Participants were assigned to receive one of three doses of alixorexton (4 mg, 6 mg, or 8 mg) or placebo once daily for six weeks, with primary and secondary endpoints focusing on wakefulness and other narcolepsy symptoms [8] Presentation Highlights - Three oral presentations will cover the safety and efficacy of alixorexton, improvements in fatigue and cognitive function, and the study design for the Vibrance-3 study evaluating alixorexton in idiopathic hypersomnia [4][5][6] - The presentations will take place during the "Targeting the orexin pathway: Emerging pharmacotherapies for narcolepsy type 1" session on September 8, 2025 [4] Research Community Engagement - The World Sleep Congress will feature leading researchers and clinicians discussing new datasets on orexin 2 receptor agonists, highlighting the ongoing commitment to improving care for patients with hypersomnolence disorders [2][3]