Axsome Therapeutics (AXSM) TD Cowen 46th Annual Health Care Conference summary

Commercial performance and expansion plans

• AUVELITY achieved $155 million in quarterly sales, annualizing over $600 million just 13 quarters post-launch.

• Field force to double from 300 to 600 reps, driven by ROI from prior expansions and anticipation of Alzheimer's disease agitation indication.

• Operating leverage is strong, with revenues outpacing OpEx 3:1 in 2025, expected to continue even with expansion and new launches.

• DTC campaign launched nationally in Q4, with plans for ongoing but moderated spend through 2026 to optimize ROI alongside sales force expansion.

• Primary care clinicians now account for about a third of AUVELITY prescriptions, with significant market opportunity remaining.

Pipeline and regulatory updates

• Pipeline includes five product candidates across nine indications, with robust progress at NDA, phase III, and earlier stages.

• AXS-05 for Alzheimer's disease agitation is under priority review, with PDUFA date set for April 30; pre-launch activities are underway.

• Clinical package for AXS-05 includes parallel group and randomized withdrawal studies, providing efficacy and safety data; FDA required a standalone safety database.

• Approximately 70% of 7 million US Alzheimer's patients have agitation symptoms, representing a large treatable population.

• Sales force expansion will target both depression and Alzheimer's agitation, with a new team planned for long-term care settings if approved.

Product-specific insights and market positioning

• AUVELITY scripts are about 50% monotherapy, with 15% first-line and 35% first-switch use; current market share is only 0.2% of the antidepressant market.

• DTC efforts in Q4 increased SG&A, but future campaigns will be more targeted, leveraging expanded sales force for higher ROI.

• Simbravo launch is targeted, focusing on headache centers and high prescribers; all three major GPOs contracted, with positive early feedback on efficacy and safety.

• AXS-12 for narcolepsy (cataplexy) is set for imminent NDA submission, leveraging existing sleep sales force for efficient launch.

• Peak sales for AXS-12 estimated at $500 million–$1 billion, with minimal incremental investment needed.