Axsome Therapeutics (AXSM) investor relations material

Recent product approval and differentiation

• Received FDA approval for Alzheimer's agitation with a clean, differentiated label and breakthrough therapy designation, highlighting rapid onset and durable treatment effect.

• Product shows a strong safety and tolerability profile, with no box warning, mortality, or sedation signals, and minimal adverse reactions.

• High unmet need in the market, with over 21 million scripts annually and most prior treatments being off-label.

• Key opinion leaders and clinicians express excitement about the new mechanism of action and potential for first-line use.

• FDA and Alzheimer's Association issued supportive statements following approval.

Launch preparation and market strategy

• Commercial launch set for June, with current focus on sales team training and updating marketing materials.

• Expanding sales force to 630 reps, including a new focus on long-term care settings, which previously had no active engagement.

• High overlap between depression and Alzheimer's agitation in long-term care, with significant opportunity for both indications.

• Historical data from similar drugs in long-term care suggest substantial revenue potential.

Payer access and reimbursement

• Expectation that at least 80% of scripts will be through Medicare Part D, with 100% covered lives and most patients facing minimal prior authorization barriers.

• Anticipate high script fulfillment rates due to favorable coverage.

• Commercial coverage for the product has grown to 86% of total covered lives.