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

Commercial performance

• Q2 revenue was $218.4M, up 46% YoY and 14% sequentially; Auvelity contributed over $180M, SUNOSI $36M and SYMBRAVO $2.3M.

• Auvelity’s field team expanded from fewer than 300 reps to over 600, including the long-term care team; Q2 revenue was generated before the expansion was complete.

• Auvelity’s estimated peak sales potential is $8B+; Medicare Part D coverage for its Alzheimer’s disease agitation indication reaches every participant, with over 85% unrestricted or not requiring prior authorization.

• SYMBRAVO revenue grew 30% sequentially in Q2; the sales team is expanding from roughly 100 to 150 reps as payer access is pursued.

• SG&A of $208M was expected to plateau through H2; R&D was expected to increase marginally from $46M, with cash flow positivity approaching and profitability expected shortly thereafter.

Product and growth outlook

• Auvelity’s Alzheimer’s disease agitation launch began in June; management expects growth to inflect one to two quarters after the field-force expansion and launch, with signs emerging in new prescribers and MDD prescriptions.

• Auvelity is positioned for continued MDD growth and the new agitation indication; management expects accelerated growth in the coming years following expanded coverage, direct-to-consumer advertising and a more than doubled sales team.

• SUNOSI generated $36M in Q2 revenue, with peak sales potential estimated at $300M–$500M; SYMBRAVO peak sales potential was estimated at $500M–$1B.

• Continued substantial growth across the commercial portfolio was anticipated for the rest of 2026 and 2027.

Pipeline and milestones

• Six differentiated candidates span 10 indications; seven trials were ongoing, with programs including smoking cessation, ADHD, binge eating disorder, excessive sleepiness, fibromyalgia and shift work disorder.

• AXS-12’s narcolepsy NDA was under FDA review, with a May 1 PDUFA date; top-line results from the solriamfetol ENGAGE phase III binge-eating-disorder trial were expected in Q4, and shift-work-disorder results next year.

• Three phase III trials were recently initiated: AXS-05 in smoking cessation and solriamfetol in pediatric and adolescent ADHD; a positive phase III adult ADHD trial had already completed.

• Management anticipated the potential for one NDA filing per year through 2031; earlier-stage work includes epilepsy, schizophrenia and Tourette syndrome.