Axsome Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Core Insights - Axsome Therapeutics reported strong financial results for Q4 and full year 2025, with total net product revenue of $196.0 million and $638.5 million, reflecting year-over-year growth of 65% and 66% respectively [4][2][3] Financial Performance - AUVELITY generated net product sales of $155.1 million in Q4 2025 and $507.1 million for the full year, marking year-over-year growth of 68% and 74% [4][3] - SUNOSI achieved net product revenue of $36.7 million in Q4 2025 and $124.8 million for the full year, representing growth of 40% and 32% year-over-year [4][3] - SYMBRAVO's net product sales were $4.1 million in Q4 2025 and $6.6 million for the full year [4][3] - The total cost of revenue was $12.3 million for Q4 2025 and $47.5 million for the full year, compared to $10.5 million and $33.3 million for the same periods in 2024 [8] - Research and development expenses were $48.8 million for Q4 2025 and $183.3 million for the full year, down from $55.0 million and $187.1 million in 2024 [8] - Selling, general, and administrative expenses rose to $169.3 million for Q4 2025 and $570.6 million for the full year, compared to $113.3 million and $411.4 million in 2024 [8] - The net loss was $28.6 million, or $(0.56) per share, for Q4 2025, and $183.2 million, or $(3.68) per share, for the full year [8] Commercial Highlights - AUVELITY is the first and only rapid-acting oral NMDA receptor antagonist and sigma-1 receptor agonist approved in the U.S. for major depressive disorder [6] - SUNOSI is the first and only dopamine and norepinephrine reuptake inhibitor approved for excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy, with approximately 54,000 prescriptions written in Q4 2025, an 11% increase from Q4 2024 [7][10] - SYMBRAVO is an oral, rapidly absorbed, multi-mechanistic COX-2 preferential inhibitor and 5-HT1B/1D agonist approved for acute migraine treatment, with 13,000 prescriptions written in Q4 2025, a 147% increase from Q3 2025 [11][15] Development Pipeline - Axsome's pipeline includes five differentiated product candidates, with significant upcoming milestones including the sNDA for AXS-05 for Alzheimer's disease agitation, which has a PDUFA target action date of April 30, 2026 [3][16] - AXS-12 for narcolepsy is on track for NDA submission in Q1 2026 [18] - Clinical trials for solriamfetol in various conditions, including ADHD and binge eating disorder, are set to initiate in 2026 [17] Corporate Updates - Axsome resolved patent litigation with Alkem Laboratories regarding a generic version of SUNOSI, allowing Alkem to sell its version under specific conditions starting in 2040 [21] - The company has sufficient cash to fund operations into cash flow positivity based on its current operating plan [5]