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]