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

Business highlights and growth

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

• Expanded sales force from under 300 to over 600 representatives to support Auvelity and new Alzheimer's disease agitation (ADA) indication.

• Auvelity now approved for both major depressive disorder (MDD) and ADA, with a summer launch for ADA and strong Medicare Part D access.

• SUNOSI and SYMBRAVO also showed growth, with SYMBRAVO up 30% sequentially and ongoing efforts to improve payer access.

• SG&A expenses plateaued, and the company is approaching cash flow positivity and profitability.

Pipeline and clinical development

• Seven ongoing clinical trials, including three new phase III studies for smoking cessation and ADHD in children and adolescents.

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

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

• Projects potential for one NDA filing per year through 2031, reflecting a robust and sustained pipeline.

• Recent business development added assets in epilepsy, schizophrenia, and Tourette syndrome.

Commercial product performance and strategy

• Auvelity demonstrates rapid onset, robust efficacy, and a distinct safety profile, driving strong adoption in both MDD and ADA.

• Direct-to-consumer advertising and expanded field force expected to accelerate growth in coming quarters.

• SUNOSI continues steady growth, supported by positive clinical data and prescriber feedback.

• SYMBRAVO shows strong demand and volume growth, with increased sales team and ongoing navigation of payer barriers.

• All three commercial products expected to contribute to substantial growth through 2027.