Short answer
Axsome Therapeutics, Inc. (AXSM) filed its fiscal 2025 10-K annual report with the SEC on Feb 23, 2026. It reported revenue of $638M (+65.5% year over year) and net income of −$183M.
- Top risk flagged: Regulatory risk: FDA Breakthrough Therapy designation for AXS-05 for AD agitation may not expedite approval or guarantee marketing authorization
FY2025 key financial metrics · XBRL
- Revenue
- $638M
- +65.5% YoY
- Net income
- −$183M
- +36.2% YoY
- Operating margin
- -26.1%
- +46.6 pp YoY
- EPS (diluted)
- −$3.68
- +38.6% YoY
- ROE
- -207.5%
- +296.3 pp YoY
- Operating cash flow
- −$93M
- +27.3% YoY
Source: XBRL data from the Axsome Therapeutics, Inc. (AXSM) FY2025 10-K on SEC EDGAR. USD.
Axsome Therapeutics, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Development, commercialization, and sales of pharmaceutical products for CNS disorders, including AUVELITY, SUNOSI, and launch of SYMBRAVO in 2025
- New product: Commercial launch of SYMBRAVO began June 2025, generating $6.6 million in net sales for the year, no sales in prior year
- Strategic shift: Expanded commercial focus from AUVELITY and SUNOSI to include SYMBRAVO, increasing total revenues 65.6% YoY to $638.5 million in 2025
- Quantitative metric: Net sales growth – AUVELITY sales up 74% to $507.1 million; SUNOSI up 33% to $120.1 million, total revenue increase from $385.7 million to $638.5 million
- Noteworthy fact: Recorded a significant decrease in net loss, $183.2 million in 2025 vs $287.2 million in 2024, reflecting scaling commercialization efforts
Risk Factors
- Regulatory risk: FDA Breakthrough Therapy designation for AXS-05 for AD agitation may not expedite approval or guarantee marketing authorization
- Geopolitical risk: EU sanctions on Russia extended to July 31, 2026, with potential supply chain and capital market disruptions impacting operations
- Supply chain risk: Dependence on third-party manufacturers subject to regulatory compliance and volume fulfillment could delay product commercialization
- Market disruption risk: Competition from other pharma, biotech firms, government agencies, and research organizations may impair operating results
- Financial risk: $570M Blackstone loan with restrictive covenants and minimum $30M liquidity may limit operational flexibility and risk default
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