Alkermes (NasdaqGS:ALKS) Q4 2025 Earnings call February 25, 2026 08:00 AM ET Company ParticipantsAmi Fadia - Managing DirectorAnya John - Research AssociateBlair Jackson - COODavid Huang - DirectorDouglas Tsao - Managing DirectorJason Gerberry - Managing DirectorJoon Lee - Managing DirectorJoseph Thome - Managing DirectorJoshua Reed - CFOJulian Pino - Biotechnology Equity ResearchRichard Pops - CEORudy Li - DirectorSandy Coombs - SVP of Investor Relations and Corporate AffairsTodd Nichols - Chief Commercial ...

Alkermes (NasdaqGS:ALKS) Q4 2025 Earnings call February 25, 2026 08:00 AM ET Speaker12Greetings, and welcome to the Alkermes' fourth quarter 2025 financial results conference call. My name is Melissa, and I will be your operator for today's call. All participant lines will be placed on mute to prevent background noise. If you should require operator assistance during the call, please press star 0 on your telephone keypad. Please note that this conference is being recorded. I will now turn the call over to S ...

Alkermes Conference Call Summary Company Overview - **Company**: Alkermes - **Industry**: Biotechnology, specifically in neuroscience and sleep medicine - **Key Products**: ALKS 2680 (orexin compound), Vivitrol, Lybalvi, Aristada, Lumryz Core Points and Arguments Financial Performance - In 2025, Alkermes' commercial business generated over **$1.4 billion** in total revenues, demonstrating strong cash flow and profitability [3] - The planned acquisition of Avidel and its product Lumryz is expected to enhance revenue growth and diversify the commercial portfolio [26] Product Development - **ALKS 2680** is entering phase three trials for narcolepsy, following a successful phase two program [3][9] - The drug has been granted **FDA Breakthrough Therapy designation** for narcolepsy type 1 (NT1) [4][30] - The market opportunity for ALKS 2680 in narcolepsy and idiopathic hypersomnia (IH) is projected to exceed **$10 billion annually** [6][8] Market Dynamics - There are approximately **200,000** people in the U.S. with narcolepsy, with only about half diagnosed [6] - Currently, **80,000** patients are receiving treatment for narcolepsy, but **80%** report residual symptoms [7] - The branded pharmaceutical market for narcolepsy treatments, particularly oxybates, is limited, with only **16,000 to 18,000** patients using them annually [8] Clinical Trials and Efficacy - The Vibrance studies demonstrated statistically significant improvements in sleep latency and excessive daytime sleepiness for ALKS 2680 [11] - Approximately **95%** of patients in the studies opted to continue into the safety extension phase, indicating high patient satisfaction [12] - The ongoing phase two study for IH is expected to complete in Q4 2026, with plans to initiate the phase three program shortly after the end-of-phase two meeting with the FDA [15][17] Future Growth and Pipeline - Alkermes plans to develop additional compounds, including **ALK-7290** for ADHD and **ALK-4510** for fatigue associated with neurodegenerative diseases [20][23] - The company aims to leverage its experience in drug development to establish a strong presence in the ADHD market, which includes approximately **15.5 million** adults and **6.5 million** children diagnosed with the condition [22] Competitive Positioning - ALKS 2680 is positioned to compete effectively against Takeda's product due to its broader therapeutic index and multiple dosing options [43][44] - The company emphasizes the importance of rigorous clinical data to create barriers for future competitors [46][47] Additional Important Insights - The acquisition of Avidel is expected to close soon, enhancing Alkermes' entry into the sleep medicine market [10][27] - The company has a strong financial foundation, with over **$1.3 billion** in net sales from its existing products [27] - Alkermes is focused on addressing unmet patient needs in narcolepsy and other sleep disorders, emphasizing the importance of patient-reported outcomes in clinical trials [50][51] This summary encapsulates the key points discussed during the conference call, highlighting Alkermes' strategic direction, product pipeline, and market opportunities.

Financial Performance & Acquisition - Alkermes' commercial business generated revenues exceeding $1.45 billion in 2025, demonstrating strong cash flow and profitability[5] - The planned acquisition of Avadel is expected to augment revenue growth and enhance profitability in 2026[5, 46] - LUMRYZ has generated over $390 million in net revenues since its launch as of September 30, 2025[49] Alixorexton Development Program - Alixorexton has blockbuster potential in narcolepsy and idiopathic hypersomnia and was granted FDA Breakthrough Therapy designation in NT1, with Phase 3 initiation planned for Q1 2026[5] - Phase 2 Vibrance-1 study showed statistically significant improvements in mean sleep latency and excessive daytime sleepiness, with clinically meaningful improvements in weekly cataplexy rates in NT1 patients[16] - Phase 2 Vibrance-2 study demonstrated clinically meaningful improvements in wakefulness and excessive daytime sleepiness in NT2 patients[19] Market Opportunity & Pipeline Expansion - The orexin 2 receptor agonist class represents a potential multi-billion dollar market opportunity in narcolepsy and idiopathic hypersomnia[9] - The oxybate market for narcolepsy and idiopathic hypersomnia generated over $1.8 billion in revenues in 2024[11] - Approximately 80,000 narcolepsy patients are treated, with 80% reporting residual symptoms[11] - Alkermes is planning a Phase 2 study of ALKS 4510 in 2026 for fatigue associated with multiple sclerosis and Parkinson's Disease, with a prevalence of approximately 1 million patients each in the US[40]

Core Insights - Alkermes plc announced positive topline results from the Vibrance-2 phase 2 study, demonstrating the efficacy of alixorexton in patients with narcolepsy type 2 (NT2) [1][14] - Alixorexton met dual primary endpoints, showing statistically significant improvements in wakefulness and excessive daytime sleepiness compared to placebo [1][6] - The drug was generally well tolerated across all tested doses, with no serious treatment-emergent adverse events reported [1][6] Study Details - The Vibrance-2 study involved 93 patients with NT2, randomized to receive alixorexton (10 mg, 14 mg, or 18 mg) or placebo for eight weeks [3][9] - The primary endpoints included improvements in mean sleep latency on the Maintenance of Wakefulness Test (MWT) and reductions in scores on the Epworth Sleepiness Scale (ESS) [9] - The 14 mg and 18 mg doses of alixorexton achieved statistical significance in improving mean sleep latency, while the 18 mg dose showed significant improvement in excessive daytime sleepiness [6][9] Safety Profile - Alixorexton was well tolerated, with most treatment-emergent adverse events being mild to moderate [6][9] - Common adverse events included pollakiuria, insomnia, urinary urgency, dizziness, and headache [6][9] - Approximately 95% of participants completed the eight-week double-blind portion of the trial and continued into an optional five-week open-label extension [6][9] Future Plans - Alkermes plans to initiate a global phase 3 program for alixorexton in the first quarter of 2026 [7][11] - Detailed results from the Vibrance-2 study, including exploratory outcomes related to cognition and fatigue, will be presented at a future scientific meeting [7][11] - The company is also conducting the Vibrance-3 phase 2 study to evaluate alixorexton in adults with idiopathic hypersomnia [7][11]

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]