Axsome Therapeutics (AXSM) 46th Annual William Blair Growth Stock Conference summary

Key business updates

• Recently received approval for AUVELITY in Alzheimer's disease agitation, expanding its indications and growth potential.

• Three commercial products (AUVELITY, SUNOSI, SYMBRAVO) now cover four indications, with a deep CNS pipeline targeting 10 high unmet-need indications.

• Cumulative peak sales guidance for commercial products raised to over $9.5 billion, with AUVELITY alone expected to exceed $8 billion.

• Field force expanded from under 300 to 630 reps to support launches and market access, especially for AUVELITY.

• Patent litigation resolved for SUNOSI (generic entry September 2040) and AUVELITY (exclusivity until 2038/2039), ensuring long commercial runways.

Financial performance and outlook

• Q1 cash balance at $305 million, with guidance to reach cash flow positivity and profitability soon.

• Q1 revenue for AUVELITY was $153 million (59% YoY growth); SUNOSI at $34 million (34% YoY growth); SYMBRAVO showing 36% sequential growth.

• SG&A expenses increased to $185 million in Q1 due to sales force expansion, expected to plateau for the rest of the year.

• R&D expenses at $53 million in Q1, expected to rise slightly as new phase III trials begin.

• Anticipates accelerated revenue growth and operating leverage as new indications launch and OpEx stabilizes.

Product and pipeline developments

• AUVELITY shows rapid onset and durable efficacy in MDD and Alzheimer's agitation, with a favorable tolerability profile and no box warning.

• SUNOSI continues to grow with strong payer access and is being developed for additional indications including ADHD, binge eating disorder, and shift work disorder.

• SYMBRAVO launch focused on headache centers and neurologists, with payer access improvements and peak sales potential of $0.5–1 billion.

• Pipeline includes AXS-05 (smoking cessation study starting), AXS-12 (NDA submitted for narcolepsy), AXS-14 (phase III trial for fibromyalgia underway), AXS-17 (epilepsy, phase II enabling), and AXS-20 (schizophrenia, phase III planned).

• Total peak sales potential for all assets estimated at over $18 billion, with more than half from commercialized products.