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

Financial Performance - Total net product revenue for Q1 2025 was $121.5 million, reflecting a 62% increase year-over-year from $75.0 million in Q1 2024 [4] - AUVELITY® generated net product sales of $96.2 million in Q1 2025, an 80% increase from $53.4 million in Q1 2024 [4] - SUNOSI® reported net product revenue of $25.2 million in Q1 2025, a 17% increase from $21.6 million in Q1 2024 [4] - The net loss for Q1 2025 was $59.4 million, or $(1.22) per share, compared to a net loss of $68.4 million, or $(1.44) per share, in Q1 2024 [11] Product Developments - SYMBRAVO® received FDA approval for the acute treatment of migraine, with a commercial launch expected in June 2025 [3][8] - NDA for AXS-14 for fibromyalgia management has been submitted to the FDA, with a decision anticipated in Q2 2025 [3][19] - Supplemental NDA for AXS-05 in Alzheimer's disease agitation is on track for submission in Q3 2025 [3][16] - NDA submission for AXS-12 for cataplexy in narcolepsy patients is expected in the second half of 2025 [3][18] Clinical Trials and Pipeline - Positive topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD were announced, with plans to initiate a Phase 3 trial in pediatric patients in 2025 [13] - A Phase 3 trial of solriamfetol in major depressive disorder with excessive daytime sleepiness is also anticipated in 2025 [13] - The EMERGE Phase 3 trial of SYMBRAVO in migraine patients with inadequate response to oral CGRP inhibitors showed positive results [14] Market Position and Coverage - Approximately 167,000 prescriptions for AUVELITY were written in Q1 2025, a 76% increase year-over-year [12] - Payer coverage for AUVELITY is approximately 78% across all channels, with 63% in commercial and 100% in government channels [12] - SUNOSI had about 46,000 prescriptions written in Q1 2025, a 12% increase year-over-year [12] Financial Guidance and Cash Position - The company believes its current cash position of $300.9 million is sufficient to fund operations until reaching cash flow positivity [5] - Total cost of revenue for Q1 2025 was $9.8 million, up from $6.3 million in Q1 2024 [4]