Axsome Therapeutics (AXSM) investor relations material

Executive summary

• Achieved total revenue of $191.2 million in Q1 2026, up 57% year-over-year, driven by AUVELITY, SUNOSI, and SYMBRAVO.

• AUVELITY net product revenue reached $153.2 million (+59% YoY); SUNOSI $33.9 million (+34% YoY); SYMBRAVO $4.1 million.

• AUVELITY received FDA approval for agitation in Alzheimer's disease, expanding its label and market potential.

• Expanded pipeline with NDA for AXS-12 in narcolepsy and acquisition of AXS-20 for schizophrenia and Tourette syndrome.

• Expanded sales force and improved payer coverage across all marketed products.

Financial highlights

• Net loss for Q1 2026 was $64.5 million ($1.26/share), up from $59.4 million ($1.22/share) in Q1 2025, reflecting higher SG&A and R&D expenses.

• Cash and cash equivalents were $305.1 million as of March 31, 2026.

• R&D expenses rose to $52.7 million, including one-time acquisition-related costs.

• SG&A expenses increased to $185 million, up from $120.8 million year-over-year, driven by commercialization activities.

• Gross margin remained high, with cost of revenue at $14.7 million.

Outlook and guidance

• Management expects continued revenue growth in 2026, with current cash expected to fund operations into cash flow positivity.

• AUVELITY commercial launch for Alzheimer's agitation indication set for June 2026.

• Updated peak sales guidance: AUVELITY at least $8 billion annually, SUNOSI $300–500 million, SYMBRAVO $500 million–$1 billion.

• Multiple late-stage clinical milestones and pivotal trial readouts expected in 2026–2027.