Axsome Therapeutics (AXSM) Bank of America 2025 Healthcare Conference summary

Commercial performance and growth initiatives

• Auvelity continues on a strong growth trajectory, with a recent field force expansion to 300 reps completed in Q1, expected to drive further NRx growth throughout the year.

• A national direct-to-consumer (DTC) campaign is planned for the second half of the year, anticipated to catalyze additional growth.

• Revenue growth is currently outpacing operating expense growth, with operating leverage expected to increase into 2025 and 2026.

• Commercial coverage for Auvelity stands at 63%, with expectations to reach over 80% at steady state, and government channel coverage is essentially 100%.

• Gross-to-net (GTN) in Q1 was in the mid-50s, expected to remain constant through the year, with potential adjustments as coverage and payer access evolve.

Market outlook and peak sales potential

• Peak sales guidance for Auvelity in MDD is $1–3 billion, with the lower end seen as secure and upside dependent on coverage expansion and DTC responsiveness over the next 12–18 months.

• Over 50% of Auvelity use is first or second line, especially in primary care, which is seen as a key driver for peak sales.

• The commercial infrastructure is positioned to support additional indications and leverage overlap in targeting.

Alzheimer's agitation label expansion

• The clinical program for Alzheimer's agitation was completed in December, with a supplemental NDA submission targeted for Q3.

• The submission package includes three positive studies with diverse designs, aligning with FDA feedback and supporting robust efficacy claims.

• If approved, Medicare Part D is expected to cover about 70% of scripts, with LIS patients facing minimal out-of-pocket costs.

• Market access strategies are being evaluated for long-term care and pre-nursing home segments, addressing unmet needs in agitation management.