Axsome Therapeutics (AXSM) investor relations material

Product approvals and market positioning

• AUVELITY received a new indication approval for Alzheimer's disease agitation, with a clean label supporting both this and the legacy MDD indication.

• The product's mechanism is highly differentiated, targeting NMDA and sigma-1, offering rapid efficacy and a favorable tolerability profile.

• AUVELITY's tolerability profile is strong, with low rates of adverse events and no box warning for the patient population.

• Synergies between MDD and ADA indications are expected, especially in primary care and long-term care settings.

• Expansion into primary care and long-term care is a key strategy to drive adoption and utilization.

Commercial strategy and sales force expansion

• Sales force expanded from 160 to 630 reps to support both indications, with a focus on primary care and long-term care.

• Dedicated long-term care team will educate and support access in these facilities, addressing unique operational needs.

• Sales efforts are context-driven, with account managers targeting MDD, ADA, or both based on regional and provider dynamics.

• Investment in direct-to-consumer (DTC) advertising began in Q4 last year, with disciplined, data-driven spending.

• DTC campaigns are ongoing, with a focus on optimizing ROI and maintaining a consistent presence.

Market access, payer coverage, and patient costs

• AUVELITY has 86% payer access in MDD, with 56% as first line or first switch; ADA launch will have 100% Medicare Part D coverage.

• 75% of Medicare Part D lives for ADA will have no prior authorization and first line or first switch access.

• Patient out-of-pocket costs for low-income subsidy patients are minimal, averaging $3-$5 per script; non-LIS patients have a $2,100 annual cap.

• Infrastructure and supply chain are established to ensure seamless product availability and access.

• Seasonality in out-of-pocket costs is expected until patients reach their annual cap.