The following is a summary of the Axsome Therapeutics, Inc. (AXSM) Q3 2024 Earnings Call Transcript:

Financial Performance:

• Axsome Therapeutics reported a third-quarter total net product revenue of $104.8 million, a significant increase from $57.8 million in the same period last year.

• Auvelity alone achieved $80.4 million in net product sales, demonstrating a 113% year-over-year growth and a 24% sequential increase from the previous quarter.

• Sunosi also showed a strong performance with a revenue of $24.4 million in Q3, up 21% over the prior year.

• The net loss for the quarter was significant at $64.6 million, with a $40.9 million non-cash charge as part of these losses.

Business Progress:

• Axsome has completed enrollment for the AD agitation Phase 3 studies (ADVANCE-2 and ACCORD-2) and is on track to report top-line results this quarter.

• The company is preparing for potential NDA submissions, following positive outcomes from ongoing studies, positioning for significant regulatory milestones soon.

• They are planning a second expansion of their Auvelity sales force to approximately 300 representatives by the first quarter of 2025, enhancing their commercial reach and effectiveness.

Opportunities:

• The company is anticipating the PDUFA decision for AXS-07 for the acute treatment of migraine by January 31, 2025, with preparations for a timely commercial launch well underway.

• Opportunities for market expansion are significant with solriamfetol under study for multiple CNS conditions which could potentially treat over 80 million people in the US alone.

Risks:

• The ramp-up of Axsome's sales force and market expansion plans are said to be robust but could face execution risks, including the pace of enrollment and regulatory approvals which may affect go-to-market timelines for their late-stage pipeline products.

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