Axsome Therapeutics (AXSM) H.C. Wainwright 28th Annual Global Investment Conference summary

Business highlights and growth

• Achieved $218.4 million in Q2 revenue, a 46% year-over-year increase, led by Auvelity with over $180 million in sales.

• Expanded sales force from under 300 to over 600 reps to support Auvelity's new Alzheimer's disease agitation indication.

• Sunosi and SYMBRAVO also showed strong growth, with Sunosi at $36 million and SYMBRAVO at $2.3 million in Q2.

• SG&A expenses plateaued, supporting near-term cash flow positivity and profitability.

• Balance sheet remains strong with $320 million in cash and only 52 million shares outstanding.

Product portfolio and market strategy

• Three marketed products: Auvelity (MDD and ADA), Sunosi (sleep disorders), and SYMBRAVO (migraine).

• Auvelity is the first and only oral NMDA receptor antagonist and sigma-1 agonist for MDD and ADA, with rapid onset and robust efficacy.

• Sunosi and SYMBRAVO are differentiated by efficacy and tolerability, with ongoing efforts to expand payer access and prescriber adoption.

• Field force expansion and direct-to-consumer advertising expected to drive accelerated growth.

• Peak sales potential for Auvelity estimated at $8+ billion, with Sunosi and SYMBRAVO targeting $300–500 million and $500 million–$1 billion, respectively.

Pipeline and clinical development

• Seven ongoing clinical trials across 10 indications in psychiatry and neurology.

• NDA for AXS-12 in narcolepsy under FDA review, with a PDUFA date of May 1.

• Three new phase III trials initiated: AXS-05 for smoking cessation, and solriamfetol for ADHD in children and adolescents.

• Anticipated top-line results for ENGAGE phase III trial in binge eating disorder in Q4 and shift work disorder trial next year.

• Expectation of one NDA filing per year through 2031, supporting sustained pipeline momentum.