Central Nervous System (CNS) treatment
Search documents
Supernus Pharmaceuticals(SUPN) - 2025 FY - Earnings Call Transcript
2025-09-04 13:47
Financial Data and Key Metrics Changes - The company continues to be profitable even through the transition from legacy products to new growth products [4] - KELBRE has shown a 25% growth in prescriptions year-over-year and a 23% growth in the first half of the current year [16] - GOCOVRI has seen a significant increase in patient retention due to Medicare redesign, with 97% of patients having less than $25 co-pay by June [24] Business Line Data and Key Metrics Changes - KELBRE has grown to 35% of the business, with an 80% satisfaction rate among adult users, significantly higher than Strattera's 53% [13] - ZERZUVEY, the first oral treatment for postpartum depression, is expected to set the standard of care, with 80% of women receiving it as a first-line treatment [7] - Anapco, the new infusion device for Parkinson's, is performing well, with demand matching that of AbbVie's product [30] Market Data and Key Metrics Changes - The back-to-school season has shown a 26% growth in the last four-week rolling average for KELBRE, indicating strong momentum [17] - The company has seen a 36% growth in unit shipments of ZERZUVEY quarter-over-quarter, reflecting a healthy brand performance [36] Company Strategy and Development Direction - The acquisition of Sage allows the company to enter women's health while maintaining its CNS focus, indicating a strategic expansion [5] - The company is prioritizing M&A to fill its portfolio with post-Phase II assets, aiming for launches between 2026 and 2030 [58][59] - The company is taking a pause to reevaluate the Sage pipeline while integrating it with its own discovery programs [40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of ZERZUVEY to become the standard of care for postpartum depression [8] - The company anticipates a strong second half of the year, driven by back-to-school momentum and continued growth in its product portfolio [19] - Management is confident that the increased demand from Medicare redesign will offset the mandatory rebates on manufacturers [26] Other Important Information - The company is exploring the potential of its pipeline, particularly focusing on SPN-817 for seizures, which has shown promising results [41] - The company is also considering the future of XERZUVEY and its potential new indications in collaboration with Biogen [39] Q&A Session Summary Question: Can you discuss the acquisition rationale for Sage? - The acquisition allows entry into women's health while maintaining CNS focus, addressing a significant unmet need in postpartum depression [5] Question: What are the expectations for the collaboration with Biogen? - The collaboration is expected to be mutually beneficial, with both companies learning from each other across various functions [10] Question: How is KELBRE performing in the adult ADHD market? - KELBRE has achieved 35% of the business in adults, with an 80% satisfaction rate, indicating strong market acceptance [13] Question: What is the outlook for GOCOVRI following Medicare redesign? - The redesign has improved patient retention, with 97% of patients having low co-pays, which is expected to continue [24] Question: How is Anapco performing compared to AbbVie's product? - Anapco's performance is in line with AbbVie's product, with both addressing a significant need in the market for advanced Parkinson's treatment [30] Question: What is the company's approach to M&A? - The company remains focused on acquiring post-Phase II assets to enhance its portfolio and ensure future growth [58][59]
Axsome Therapeutics Hosts Frontiers in Brain Health R&D Day Reviewing Industry-Leading Late-Stage CNS Pipeline
Globenewswire· 2025-07-21 11:30
Core Insights - Axsome Therapeutics is hosting its Frontiers in Brain Health R&D Day to showcase its CNS pipeline targeting various psychiatric and neurological conditions [1][2] - The event features presentations from six expert clinicians discussing clinical data from the company's pipeline programs [2] - Axsome Therapeutics focuses on developing differentiated products with novel mechanisms of action to improve patient outcomes in CNS disorders [4][5] Company Overview - Axsome Therapeutics is a biopharmaceutical company specializing in the treatment of central nervous system (CNS) conditions [4] - The company has FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine [5] - Axsome's pipeline addresses serious neurological and psychiatric conditions affecting over 150 million people in the United States [5] Event Details - The R&D Day is intended for institutional investors and sell-side analysts, with a live webcast available for broader access [3] - Presentations will cover conditions such as Alzheimer's disease, fibromyalgia, ADHD, and narcolepsy, with insights from leading experts in the field [2][4]
Axsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today
Globenewswire· 2025-07-21 11:00
Core Viewpoint - Axsome Therapeutics is celebrating its achievements in the treatment of central nervous system (CNS) disorders by ringing the NASDAQ opening bell, highlighting its innovative pipeline and recent product launch [1][2]. Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on CNS conditions, aiming to address critical gaps in care with differentiated products [3]. - The company has an industry-leading neuroscience portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine [3]. - Axsome's late-stage development programs target a wide range of serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [3]. Recent Developments - The opening bell ceremony coincides with Axsome's Frontiers in Brain Health R&D Day, showcasing its late-stage CNS product candidates and the recent availability of SYMBRAVO by prescription in the U.S. [2]. - The event emphasizes the company's commitment to improving the lives of patients with serious CNS conditions [2].
Axsome Therapeutics to Showcase Its Innovative CNS Pipeline at Upcoming Frontiers in Brain Health R&D Day in New York City on July 21
Globenewswire· 2025-07-07 11:00
Core Insights - Axsome Therapeutics, Inc. is hosting its Frontiers in Brain Health R&D Day on July 21, 2025, to showcase its innovative late-stage CNS pipeline [1][2] - The event will feature discussions from physician key opinion leaders on current indications in neurology and psychiatry, along with an overview of clinical development programs by Axsome's management team [2] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine [4] - The company aims to address significant gaps in care by developing differentiated products that lead to meaningful advancements in patient outcomes, impacting over 150 million people in the United States [4]
Axsome Therapeutics Showcases Innovation in Sleep Medicine with Multiple Presentations for AXS-12 and Solriamfetol at SLEEP 2025
Globenewswire· 2025-06-11 11:00
Core Insights - Axsome Therapeutics, Inc. is presenting seven studies at the SLEEP 2025 conference, focusing on AXS-12 and solriamfetol, which are aimed at treating central nervous system disorders [1] Group 1: AXS-12 Presentations - AXS-12 is being evaluated in a Phase 3 open-label extension and randomized-withdrawal trial for narcolepsy, with topline results presented by Dr. Richard Bogan [2] - The impact of AXS-12 on symptom severity and functional impairment in narcolepsy is being discussed, with results from the Phase 3 SYMPHONY trial presented by Dr. Michael Thorpy [2] - A subgroup analysis from the CRESCENDO survey highlights residual symptom burden in patients with narcolepsy who are satisfied with treatment, also presented by Dr. Michael Thorpy [2] Group 2: Solriamfetol Presentations - The effects of solriamfetol on neuropsychological outcomes in patients with obstructive sleep apnea are being presented in the real-world SURWEY study by Dr. Yaroslav Winter [3] - Real-world usage of solriamfetol for excessive daytime sleepiness in patients with obstructive sleep apnea in the U.S. is being discussed, led by Dr. Yang Zhao [3] Group 3: Product Information - AXS-12 (reboxetine) is a selective norepinephrine reuptake inhibitor under development for narcolepsy, with FDA Orphan Drug Designation granted [4][5] - Solriamfetol is a dopamine and norepinephrine reuptake inhibitor being developed for multiple conditions, including ADHD and excessive sleepiness associated with shift work disorder [6] Group 4: Company Overview - Axsome Therapeutics is focused on developing innovative treatments for CNS conditions, with a portfolio that includes FDA-approved therapies for major depressive disorder and excessive daytime sleepiness [7]