Axsome Therapeutics (AXSM) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Company overview and strategy

• Focus on CNS disorders with three commercial products: AUVELITY, SYMBRAVO, and SUNOSI.

• AUVELITY is approved for major depressive disorder and Alzheimer's disease agitation, with recent launch activities.

• Deep pipeline includes NDA-stage AXS-12 for narcolepsy (PDUFA date May 1) and multiple phase III programs.

• Recent expansion of commercial team and infrastructure, especially for AUVELITY.

• Emphasis on execution in both commercial and pipeline development.

Pipeline and upcoming catalysts

• ENGAGE phase III trial of solriamfetol (SUNOSI) in binge eating disorder with top-line results expected Q4.

• Ongoing label expansion efforts for solriamfetol in MDD with EDS, shift work disorder, and ADHD.

• AXS-05 SUMMIT phase III trial in smoking cessation recently initiated; enrollment underway.

• AXS-14 (esreboxetine) in fibromyalgia and new programs AXS-17 (epilepsy) and AXS-20 (schizophrenia, Tourette) progressing.

• AXS-20 acquired from Takeda, with phase III trial in schizophrenia planned and tech transfer ongoing.

AUVELITY commercial performance and market opportunity

• Peak sales potential for AUVELITY in MDD and Alzheimer's agitation estimated at over $8 billion, based on low market share assumptions.

• Sales force doubled from 300 to 600, with new LTC team for broader reach.

• Exclusivity through Q1 2039 if pediatric indication is secured.

• Early launch feedback highlights rapid reduction in agitation and favorable tolerability profile.

• No black box warning for mortality risk in dementia, differentiating from competitors.