Group 1 - The event is the Fifth Annual TD Cowen Novel Mechanisms in Neuropsychiatry and Epilepsy Summit, featuring Axsome Therapeutics [1] - Axsome Therapeutics has made significant progress in both commercial and development aspects over the past year [2] - The company is expected to provide insights into future expectations for investors, particularly looking towards the end of 2025 and early 2026 [2] Group 2 - In Q2, Axsome Therapeutics reported net sales of $150 million, with Auvelity contributing $120 million and Sunosi $30 million [4] - The recent launch of SYMBRAVO generated approximately $400,000 in its first 2.5 weeks [4]

Financial Performance - Axsome Therapeutics reported quarterly losses of 47 cents per share, significantly better than the analyst consensus estimate of losses of $1.07 per share [1] - The company achieved quarterly sales of $150.04 million, exceeding the analyst consensus estimate of $140.33 million [1] Company Commentary - The CEO of Axsome Therapeutics highlighted strong underlying demand for their medicines, effective commercial execution, solid regulatory progress, and advancements in their neuroscience pipeline [2] - The recent approval and launch of SYMBRAVO for migraine, along with the accelerating performance of AUVELITY for depression and SUNOSI for excessive daytime sleepiness, were noted as positive developments [2] Stock Performance and Analyst Ratings - Following the earnings announcement, Axsome Therapeutics shares fell by 3.4% to trade at $102.89 [3] - Analysts have adjusted their price targets for Axsome Therapeutics, with RBC Capital maintaining an Outperform rating and raising the price target from $184 to $189, and B of A Securities maintaining a Buy rating with a price target increase from $173 to $176 [5]

Financial Performance & Projections - Axsome reported Net Product Revenue of $150 million in 2Q 2025, a 72% increase compared to $872 million in 2Q 2024 [21] - AUVELITY Net Product Sales reached $1196 million in 2Q 2025, an 84% increase from $650 million in 2Q 2024 [21] - SUNOSI Net Product Revenue was $30 million in 2Q 2025, a 40% increase compared to $221 million in 2Q 2024 [21] - SYMBRAVO Net Product Sales were $04 million in 2Q 2025 [21] - The company estimates a combined peak sales potential of $165 billion across its differentiated portfolio [16] Clinical & Regulatory Milestones - The company commercially launched SYMBRAVO in the US in June 2025 [20] - Positive topline results were achieved from the EMERGE Phase 3 trial of SYMBRAVO in oral CGRP non-responders in 1Q 2025 [20] - Positive topline results were achieved from the FOCUS Phase 3 trial of solriamfetol in ADHD in adults in 1Q 2025 [20] - Topline results were achieved from the PARADIGM Phase 3 trial of solriamfetol in MDD in 1Q 2025 [20] - An sNDA submission for AXS-05 in Alzheimer's disease agitation is expected in 3Q 2025 [20] - An NDA submission for AXS-12 in narcolepsy is expected in 4Q 2025 [20] Market & Pipeline - The company is developing new indications across approved products and has Phase 3 development programs ongoing [13] - The company plans to initiate a Phase 3 trial of solriamfetol in ADHD in pediatric patients in 4Q 2025 [20] - The company plans to initiate a Phase 3 trial of solriamfetol in MDD with EDS in 4Q 2025 [20] - The company plans to initiate a Phase 3 trial of AXS-14 in fibromyalgia in 4Q 2025 [20] - The company plans to initiate a Phase 2/3 trial of AXS-05 in smoking cessation in 4Q 2025 [20]

Core Insights - Axsome Therapeutics reported strong financial performance for Q2 2025, with total net product revenue of $150.0 million, reflecting a 72% year-over-year growth and a 24% sequential increase [4][9] - The company highlighted the successful launch of SYMBRAVO for migraine treatment and the continued growth of AUVELITY for depression and SUNOSI for excessive daytime sleepiness [3][4] - Axsome is on track for significant regulatory submissions, including AXS-05 for Alzheimer's disease agitation in Q3 2025 and AXS-12 for narcolepsy in Q4 2025 [3][4] Financial Highlights - Total net product revenue for Q2 2025 was $150.0 million, up from $87.2 million in Q2 2024 [4] - AUVELITY sales reached $119.6 million, an 84% increase year-over-year, while SUNOSI generated $30.0 million, a 35% increase [4] - The net loss for Q2 2025 was $48.0 million, or $(0.97) per share, compared to a net loss of $79.3 million, or $(1.67) per share, in Q2 2024 [9][29] Commercial Highlights - AUVELITY's market access expanded by 28 million new covered lives, achieving approximately 83% overall payer coverage [10] - SYMBRAVO launched on June 10, 2025, with initial sales of $0.4 million and a GPO contract signed for potential formulary coverage [4][10] - SUNOSI prescriptions increased by 13% year-over-year, with payer coverage at approximately 83% [10] Development Pipeline - AXS-05 is being developed for Alzheimer's disease agitation and has received FDA Breakthrough Therapy designation [13][15] - AXS-12 is targeted for cataplexy in narcolepsy, with an NDA submission anticipated in Q4 2025 [17] - The company is advancing multiple late-stage programs, including trials for ADHD, binge eating disorder, and fibromyalgia [12][14][18] Corporate Updates - Axsome resolved patent litigation with Hetero Labs regarding SUNOSI, allowing for future generic sales under specific conditions [22] - The company hosted a research and development day featuring expert discussions on its late-stage pipeline [22] - Axsome's cash and cash equivalents totaled $303.0 million as of June 30, 2025, down from $315.4 million at the end of 2024 [9][27]

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]

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].

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]

Company Overview - Axsome Therapeutics, Inc. is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a mission to address significant gaps in care and improve patient outcomes through innovative 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, along with multiple late-stage development programs targeting serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [3] Industry Context - Migraine affects approximately 40 million people in the U.S. and is the second leading cause of disability worldwide, highlighting the critical need for effective treatment options [2] - The Association of Migraine Disorders emphasizes the importance of funding and advancing migraine research, as well as educating patients and healthcare providers about the condition [2] Community Engagement - In recognition of Migraine and Headache Awareness Month, Axsome is supporting various Miles for Migraine Run, Walk or Relax events across the U.S. and providing resources for patients and their families affected by migraine [1][3] - The company collaborates with leading migraine advocacy organizations to share educational resources and support for individuals impacted by migraine [3][5]

Core Insights - Axsome Therapeutics has launched SYMBRAVO, a novel treatment for acute migraine, which combines meloxicam and rizatriptan, targeting multiple pathways involved in migraine attacks [1][4][30] - SYMBRAVO provides rapid pain relief within 2 hours and can sustain pain freedom for up to 24 hours in some patients after a single dose [1][4] - The treatment addresses a significant unmet need, as 63% of migraine patients reported dissatisfaction with their current treatment options [2][30] Company Overview - Axsome Therapeutics is focused on developing innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for various conditions [30] - The company utilizes its patented MoSEIC™ technology to enhance the absorption and effectiveness of its migraine treatment [4][30] - Axsome is committed to improving patient outcomes through comprehensive support services, including the SYMBRAVO On My Side program, which offers financial assistance and educational resources [3][30] Industry Context - Migraine affects approximately 40 million people in the U.S. and is the second leading cause of disability worldwide [2][30] - The introduction of SYMBRAVO is expected to provide a valuable new option for patients who have not found relief with existing treatments [2][30] - The National Headache Foundation emphasizes the importance of new FDA-approved options to address the needs of the migraine community [2]

Core Viewpoint - Axsome Therapeutics has reached a settlement with Hetero Labs regarding patent litigation over its product SUNOSI, allowing Hetero to market a generic version under specific conditions starting in 2040 [1][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, and migraines [3]. Settlement Details - The settlement permits Hetero to sell a generic version of SUNOSI starting on or after September 1, 2040, if pediatric exclusivity is granted, or on or after March 1, 2040, if not, contingent upon FDA approval [1]. - The agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review [2]. Ongoing Litigation - Axsome continues to pursue similar patent litigation against other parties related to SUNOSI in the U.S. District Court for the District of New Jersey [2].