Axsome Therapeutics (AXSM) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Key achievements and growth

• Achieved 29% sequential sales growth for Auvelity in Q2, reflecting strong commercial momentum.

• Successfully transitioned from a development-stage to a commercial-stage organization, expanding operational functions.

• Managing a broad and growing portfolio of assets in both development and commercial stages.

Pipeline and clinical trial updates

• Multiple pivotal clinical trial readouts expected for Alzheimer's disease agitation (AXS-05) by year-end and into next year.

• Two phase III trials (ACCORD-2 and ADVANCE-2) for AXS-05 in Alzheimer's agitation are ongoing, with different study designs to support regulatory submission.

• Phase III trial for solriamfetol in adult ADHD is underway, targeting a large and underserved market.

• Positive phase III results for AXS-12 in narcolepsy, with a long-term safety extension trial readout expected this year.

• AXS-07 migraine study in patients who failed oral CGRPs to read out by year-end.

Product differentiation and market strategy

• Auvelity offers a novel mechanism of action as an NMDA receptor antagonist and sigma-1 receptor agonist, with rapid and durable antidepressant effects.

• About 50% of Auvelity use is in first- or second-line depression therapy, with 15% first-line and 35% second-line.

• Focused on educating clinicians and adapting promotional efforts based on market feedback.