Axsome Therapeutics — Second Quarter 2026 Earnings Summary

Financial Performance

• Total net product revenue reached $218.4 million, a 46% year-over-year increase from $150.0 million in Q2 2025.
• AUVELITY net product sales were $180.3 million, up 51% year-over-year from $119.6 million.
• SUNOSI net product revenue was $35.8 million, up 20% year-over-year from $30.0 million, comprising $33.8 million in sales, $1.5 million in royalties, and $0.5 million in milestones.
• SYMBRAVO net product sales were $2.3 million, representing a 461% year-over-year increase from $0.4 million.
• Total cost of revenue was $13.6 million, compared to $13.4 million in the prior year period.
• Research and development expenses were $46.2 million, down from $49.5 million in Q2 2025, driven by lower costs for AXS-05 and AXS-14.
• Selling, general, and administrative expenses were $208.1 million, up from $130.3 million in Q2 2025, primarily due to AUVELITY and SYMBRAVO commercialization activities.
• Net loss for the quarter was $51.3 million ($0.99 per share), compared to a net loss of $48.0 million ($0.97 per share) in Q2 2025; the loss included $27.1 million in stock-based compensation.
• Cash and cash equivalents totaled $319.9 million at June 30, 2026, down from $322.9 million at December 31, 2025.
• Total liabilities were $678.1 million at June 30, 2026, including $70.0 million in short-term borrowings and $117.9 million in long-term loan payable.

Guidance and Future Outlook

• Management expects commercial momentum to build over the remainder of the year, specifically citing continued AUVELITY growth in Alzheimer's disease agitation and major depressive disorder.
• The company believes current cash is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.
• Topline results for the ENGAGE Phase 3 trial (solriamfetol in binge eating disorder) are anticipated in Q4 2026.
• Topline results for the SUSTAIN Phase 3 trial (solriamfetol in shift work disorder) are anticipated in 2027.
• The PDUFA target action date for the AXS-12 NDA submission for cataplexy in narcolepsy is May 1, 2027.

Business Segments and Product Lines

• AUVELITY: Launched for agitation associated with dementia due to Alzheimer's disease in June 2026. New-to-brand prescriptions for patients ≥65 years old increased 126% in the first eight weeks post-launch compared to the prior quarter. Overall new-to-brand prescriptions increased 26% quarter-over-quarter, with approximately 266,000 total prescriptions written in Q2 2026.
• SUNOSI: Approximately 61,000 prescriptions were written in the U.S. in Q2 2026, a 14% increase year-over-year and 8% increase quarter-over-quarter.
• SYMBRAVO: Approximately 23,500 prescriptions were written in Q2 2026, a 30% increase quarter-over-quarter. The sales force expansion to approximately 150 representatives is substantially complete.
• Pipeline: FOCUS-2 and FOCUS-3 Phase 3 trials for solriamfetol in children and adolescents with ADHD were initiated in June and July 2026. A pivotal Phase 2/3 trial for AXS-05 in smoking cessation is on track to initiate in Q3 2026.

Market and Competitive Landscape

• AUVELITY payer coverage is at approximately 89% of all lives covered (82% commercial, 100% government).
• SUNOSI payer coverage is at approximately 82% of all lives covered (96% commercial, 59% government).
• SYMBRAVO payer coverage is at approximately 57% of all lives covered (56% commercial, 57% government).
• The company notes positive prescriber feedback and recognition of AUVELITY's differentiated profile in the Alzheimer's disease agitation market.

Risks and Challenges

• The press release includes standard forward-looking statement risks regarding commercial success of products, payer coverage maintenance, clinical trial timing and costs, regulatory approval timelines, and intellectual property disputes.
• Specific risks include the ability to fund additional clinical trials and the impact of capital requirements on the cash runway.

Management Commentary and Tone

• CEO Herriot Tabuteau described the second quarter as "highly productive," citing robust commercial growth driven by strong underlying demand and important regulatory and clinical progress.
• Management expressed confidence that Axsome is "well positioned to deliver substantial value to patients and shareholders" through commercial execution and pipeline advancement.

Other Key Points

• The FDA accepted the NDA submission for AXS-12 for cataplexy in narcolepsy.
• Shares of common stock outstanding were 52,299,889 at June 30, 2026.
• A conference call and webcast were hosted on August 10, 2026, at 8:00 AM Eastern to discuss results.