Axsome Posts Strong Q1 Revenue Growth, Advances Late-Stage CNS Pipeline
Financial Highlights:
• Total Q1 2025 net product revenue: $121.5 million (up 62% YoY)
o AUVELITY: $96.2 million (up 80% YoY)
o SUNOSI: $25.2 million (up 17% YoY)
• Net loss: $59.4 million or $(1.22) per share, compared to $(68.4) million or $(1.44) per share in Q1 2024
• Cash and equivalents: $300.9 million as of March 31, 2025
Commercial Performance:
• AUVELITY: 167,000 prescriptions in Q1 2025 (up 76% YoY), 78% payer coverage across channels
• SUNOSI: 46,000 prescriptions (up 12% YoY), 83% payer coverage
Pipeline and Regulatory Updates:
• SYMBRAVO (for acute migraine) approved in January; U.S. commercial launch expected June 2025
• AXS-14 (fibromyalgia): NDA submitted; FDA filing decision expected Q2 2025
• AXS-05 (Alzheimer’s agitation): Supplemental NDA submission on track for Q3 2025
• AXS-12 (narcolepsy): NDA submission planned for 2H 2025
Clinical Trial Milestones:
• Solriamfetol (ADHD): Positive Phase 3 results in adults; pediatric trial planned for 2025
• Solriamfetol (MDD with EDS): Phase 3 trial to start in 2025
• Ongoing Phase 3 trials: Binge eating disorder (ENGAGE) and shift work disorder (SUSTAIN) – topline results expected in 2026
Litigation Update:
• Settlement reached with Hikma on SUNOSI patent litigation; generic entry not expected before 2040

Axsome Reports Positive Phase 3 Results for Solriamfetol in ADHD Trial

On March 25, 2025, Axsome Therapeutics announced that its Phase 3 FOCUS trial evaluating solriamfetol for the treatment of attention deficit hyperactivity disorder (ADHD) met its primary and key secondary endpoints. The company’s investigational use of solriamfetol, currently approved for other indications, demonstrated significant clinical efficacy in adults with ADHD.

The successful outcome of the FOCUS study marks a major milestone for Axsome’s pipeline, potentially expanding the use of solriamfetol into a new therapeutic area. Full details were shared in a press release attached to the company’s 8-K filing with the SEC.

Axsome Therapeutics announced that it has reached a settlement agreement with Hikma Pharmaceuticals USA, resolving patent litigation related to Axsome’s drug Sunosi (solriamfetol). The litigation arose from Hikma’s submission of an Abbreviated New Drug Application to the FDA seeking approval to market a generic version of Sunosi. Under the settlement, Axsome will grant Hikma a license to sell its generic version starting on or after March 1, 2040, or September 1, 2040, if pediatric exclusivity is granted. The agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. Litigation against other parties regarding Sunosi remains ongoing.

Axsome Therapeutics, Inc. announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA), supporting a supplemental NDA submission for AXS-05 in treating agitation associated with Alzheimer’s disease. The company plans to proceed with its submission based on this feedback.

A full press release detailing this development has been filed as an exhibit with the U.S. Securities and Exchange Commission.

Axsome Therapeutics has reported strong financial growth for the fourth quarter and full year of 2024, highlighting significant revenue increases and progress in its clinical pipeline. The company achieved total net product revenue of $118.8 million for the fourth quarter, representing 66% year-over-year growth, and $385.7 million for the full year, an 88% increase compared to 2023.

Key contributors to revenue growth include Auvelity, with fourth-quarter sales of $92.6 million, marking an 89% increase from the prior year, and full-year sales reaching $291.4 million, up 124%. Sunosi also performed well, generating $26.2 million in fourth-quarter revenue and $94.3 million for the year, reflecting year-over-year growth of 16% and 26%, respectively.

Axsome achieved a major regulatory milestone with the U.S. approval of Symbravo for the acute treatment of migraines. The company also completed a Phase 3 clinical program for AXS-05 in Alzheimer's disease agitation, with an NDA submission expected in the second half of 2025. Additionally, positive results were reported from the Phase 3 ENCORE trial for AXS-12 in narcolepsy, with an NDA submission anticipated in the latter half of the year.

Research and development expenses increased to $187.1 million for the year, reflecting ongoing clinical trials and expansion efforts. Selling, general, and administrative expenses also rose to $411.4 million due to commercialization activities for Auvelity and Sunosi. The company reported a net loss of $74.9 million for the fourth quarter and $287.2 million for the full year, impacted by non-cash charges, stock-based compensation, and acquisition-related expenses.

At year-end, Axsome had cash and cash equivalents of $315.4 million, compared to $386.2 million at the end of 2023. The company remains focused on advancing its late-stage pipeline and expanding its market presence with multiple new product launches anticipated in the coming months.