Axsome Therapeutics (AXSM) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Business performance and growth drivers

• Achieved over $500 million in sales for Auvelity within three years of launch, driven by increased demand and market access improvements.

• Sales force expanded from 300 to 600 to capitalize on primary care opportunities and support anticipated new indications.

• Largest prescriber growth seen in primary care, with significant market potential remaining.

• Over 50% of Auvelity prescriptions are now first line or first switch, reflecting broader adoption.

• Peak sales guidance for Auvelity remains at $2.5–$6 billion, with confidence in achieving these targets.

Market access, reimbursement, and financial outlook

• Achieved 86% total covered lives, 78% commercial, and 100% government channel coverage for Auvelity.

• GTN (gross-to-net) for Q4 was in the high 40s%, expected to remain stable into 2026.

• Medicare Part D will be the primary channel for Alzheimer's disease agitation (ADA), with full coverage secured.

• Operating leverage maintained despite sales force expansion, with near-term cash flow positivity in sight.

• Recent quarters have approached cash flow break-even, with EPS positivity on the near-term horizon.

Pipeline and clinical development updates

• sNDA for Auvelity in ADA under FDA priority review, with PDUFA date set for April 30.

• Clinical program for ADA included four controlled trials (three positive), showing rapid and durable efficacy and favorable safety in elderly patients.

• Pre-launch activities for ADA include non-branded campaigns and physician education.

• Solriamfetol expansion trials in binge eating disorder (BED) and shift work disorder ongoing, with BED topline data expected in H2 2024.

• AXS-12 NDA for narcolepsy imminent, leveraging existing sleep sales force for launch.