Axsome Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update

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]