AXSM · Axsome Therapeutics, Inc.

Axsome delivered robust top-line growth in Q1 2026, with total net product revenue rising 57% YoY to $191.2 million — driven primarily by AUVELITY ($153.2M, +59% YoY), SUNOSI ($33.9M, +34% YoY), and the debut of SYMBRAVO ($4.1M). The growth reflects expanding prescriber reach (223,000 TRx for AUVELITY, +35% YoY), improved payer access (86% lives covered for AUVELITY; 83% for SUNOSI), and early traction for SYMBRAVO (17,000 TRx, +36% QoQ). Critically, the April 2026 FDA approval of AUVELITY for agitation associated with Alzheimer’s disease dementia — a first-in-class indication supported by Priority Review and Breakthrough Therapy designation — establishes a major new commercial opportunity launching in June 2026. Pipeline progress includes the NDA submission for AXS-12 in narcolepsy and acquisition of AXS-20 (balipodect), a PDE10A inhibitor for schizophrenia and Tourette syndrome. While SG&A surged 53% YoY to $185.0 million — largely due to AUVELITY Alzheimer’s launch prep and SYMBRAVO commercialization — and R&D rose 18% YoY to $52.7 million (including a one-time acquisition-related expense), the company maintained $305.1 million in cash as of March 31, 2026, and affirmed its path to cash flow positivity under the current operating plan. Management highlighted the strategic inflection point: three differentiated CNS medicines now approved for four indications, plus six late-stage pipeline candidates targeting ten high-unmet-need conditions — positioning Axsome to advance brain health while scaling revenue sustainably.