Axsome Therapeutics (AXSM) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Business focus and product portfolio

• Focused on CNS disorders with two marketed products: Auvelity for major depressive disorder and Sunosi for excessive daytime sleepiness in narcolepsy and sleep apnea.

• Five late-stage CNS product candidates in clinical development for ten indications, with ongoing clinical trials and NDA filings.

Recent milestones and upcoming catalysts

• NDA resubmission for AXS-07 (migraine) announced, with PDUFA date in January 2025.

• Additional NDA filing for AXS-14 in fibromyalgia expected in Q3.

• Pivotal trial readouts for AXS-05 in Alzheimer's disease agitation and solriamfetol in ADHD expected by year-end.

• EMERGE trial of AXS-07 in CGRP-failure migraine patients and AXS-12 long-term safety trial in narcolepsy also set to read out by year-end.

Auvelity commercial performance and strategy

• Over 120,000 patients prescribed in the latest quarter, with 29% sequential prescription growth.

• Sales force expansion contributed to growth, targeting both psychiatrists and primary care providers.

• Growth driven by both increased prescriber depth and breadth, with expanded payer coverage adding 22 million covered lives.

• Persistency rates exceed those of SSRIs, and product use has shifted toward earlier lines of therapy (15% first line, 35% second line).