Axsome Therapeutics (AXSM) Wells Fargo 21st Annual Healthcare Conference summary

Commercial performance and product updates

• Three commercial products are showing robust growth: AUVELITY (major depressive disorder, Alzheimer's agitation), SYMBRAVO (migraine), and Sunosi (excessive daytime sleepiness, narcolepsy, sleep apnea).

• AUVELITY's sales team has more than doubled, with significant impacts on new-to-brand prescriptions (NBRx) and dynamic growth in key subpopulations, especially Medicare 65+.

• AUVELITY's launch in Alzheimer's agitation is underway, with early positive feedback on efficacy and safety, and a sampling program supporting trial in Medicare patients.

• Long-term care facility engagement began post-AD agitation approval, with a gradual onboarding process expected to drive future growth.

• AUVELITY has broad Medicare coverage, with over 85% of patients having access without prior authorization.

Financial position and guidance

• Cash position at end of Q2 was approximately $330 million, supporting cash flow positivity and future profitability.

• Operating leverage is increasing, with SG&A expenses plateauing and top-line growth expected to drive profitability in the back half of the year.

• Gross-to-net discounts for AUVELITY are improving, with Q2 at approximately 50% and further improvement anticipated.

• Peak sales guidance for AUVELITY in MDD and agitation is $4 billion each, with current market penetration at 0.26% of the antidepressant market.

• Exclusivity for AUVELITY could extend through Q1 2039, pending pediatric indication approval.

Pipeline and clinical development

• Late-stage pipeline includes AXS-12 for narcolepsy (NDA under FDA review, PDUFA date May 1), and multiple phase III trials in binge eating disorder, ADHD, smoking cessation, and more.

• ENGAGE study for binge eating disorder (solriamfetol) expects top-line results in Q4; positive results would prompt a second trial.

• Shift work disorder program targets $300–$500 million peak sales, with top-line data expected next year.

• ADHD program is enrolling pediatric patients, with prior adult data showing efficacy comparable to stimulants and a distinct safety profile.

• Smoking cessation phase III trial underway, comparing AXS-05 to placebo and bupropion, with expectation of two studies for approval.

• AXS-12 for narcolepsy type 1 offers a distinct mechanism and efficacy profile, with potential for orphan drug pricing and synergy with existing sleep franchise.