Axsome Therapeutics, Inc. Q1 FY2025 earnings call

CEO's Remarks

• Axsome entered 2025 with strong momentum, achieving 62% year-over-year total revenue growth driven by Auvelity and Sunosi.
• FDA approved Symbravo, the second internally developed product.
• Progress on advancing 3 novel NDA stage product candidates (AXS-14, AXS-05, AXS-12) and executing across multiple Phase III clinical programs.

CFO's Remarks

• Total product revenues were $121.5 million for Q1 2025, up from $75 million in the comparable period of 2024.
• R&D expenses were $44.8 million in Q1 2025 compared to $36.8 million in the comparable period of 2024.
• SG&A expenses were $120.8 million in Q1 2025 compared to $99 million in the comparable period of 2024.

CCO's Remarks

• Auvelity had approximately 167,000 prescriptions in Q1, representing 76% year-over-year growth.
• Sunosi had over 46,000 prescriptions in Q1, representing 12% year-over-year growth.
• Symbravo launch preparations are progressing, including build-out of the sales team and development of marketing materials.

Total product revenues for the first quarter of 2025 were $121.5 million, representing a year-over-year growth of 62%. Auvelity net product sales were $96.2 million in Q1 2025, which is an 80% year-over-year growth. Sunosi net product revenues were $25.2 million in Q1 2025, with a 17% year-over-year growth. Auvelity and Sunosi GTN discount were both in the mid-50% range and are anticipated to remain in this range for the balance of the year.

Financial Guidance

• GTN is anticipated to remain in the mid-50% range for the balance of 2025.

Operational Guidance

• Confident current cash balance of $300.9 million is sufficient to fund anticipated operations into cash flow positivity.
• Anticipate launching a national DTC campaign for Auvelity later in 2025.

Risks Mentioned

• Monitoring trade policy developments, including proposed pharmaceutical tariffs, but believes any potential impact to the business would be immaterial.

Q: Leonid Timashev asked about FDA interactions and AXS-05 in Alzheimer's agitation.

A: Mark Jacobson responded that engagement and dialogue with FDA is status quo, and AXS-05 with breakthrough therapy designation is eligible for priority review.

Q: Marc Goodman asked about DTC advertising for Auvelity and orexin.

A: Ari Maizel responded that Auvelity's national DTC campaign is expected later in 2025, and AXS-12 is optimistic with strong impact on cataplexy and other symptoms.

Q: Andrew Tsai asked about Auvelity's settlement with Teva and additional indications.

A: Hunter Murdock responded Teva has 180-day regulatory exclusivity, and Herriot Tabuteau mentioned AXS-05 is on track for sNDA submission in third quarter and smoking cessation trial initiation this year.

Q: Ram Selvaraju asked about Symbravo coverage cadence and Solriamfetol's indications.

A: Ari Maizel responded on Symbravo coverage cadence being premature to specify, and Herriot Tabuteau discussed Solriamfetol's positive results in ADHD and binge-eating disorder being too early to pronounce.