Axsome Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total net product revenue reached $259.7 million for the third quarter of 2026, a 52% year-over-year increase compared to $171.0 million in the same period of 2025.
• AUVELITY net product sales were $207.6 million, up 53% year-over-year from $136.1 million in 2025.
• SUNOSI net product revenue was $48.2 million, up 47% year-over-year from $32.8 million in 2025; this figure included $38.5 million in sales, $1.2 million in royalty revenue, and $8.5 million in milestone revenue.
• SYMBRAVO net product sales were $3.9 million, representing an 88% year-over-year increase from $2.1 million in 2025.
• Total cost of revenue was $17.8 million for the quarter, compared to $11.9 million in the prior year period.
• Research and development expenses were $50.6 million, an increase from $40.2 million in the comparable 2025 period.
• Selling, general, and administrative expenses were $203.1 million, up from $150.2 million in the prior year period.
• Net loss for the quarter was $12.9 million, or $(0.25) per share, a significant improvement from a net loss of $47.2 million, or $(0.94) per share, in 2025.
• The net loss included $26.4 million in stock-based compensation expense.
• Cash and cash equivalents totaled $313.9 million as of September 30, 2026, down from $322.9 million at December 31, 2025.
• Shares of common stock outstanding were 52,576,839 at September 30, 2026.
• Total assets were $826.8 million as of September 30, 2026, compared to $689.8 million at December 31, 2025.
• Total liabilities were $721.3 million as of September 30, 2026, compared to $601.5 million at December 31, 2025.
• Short-term borrowings remained at $70.0 million, and long-term loan payable was $118.1 million as of September 30, 2026.

Guidance and Future Outlook:

• Management expects sustained momentum driven by strong underlying demand for AUVELITY in major depressive disorder and continued acceleration of new patient initiations in Alzheimer's disease agitation.
• The company believes its current cash is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.
• The company anticipates multiple regulatory and clinical trial milestones in the coming quarters.

Business Segments and Product Lines:

• AUVELITY: Approximately 302,000 total prescriptions were written in the third quarter, a 40% year-over-year increase and 14% quarter-over-quarter increase. New-to-brand prescriptions increased 44% year-over-year and 21% quarter-over-quarter. New-to-brand and total prescriptions among patients aged 65 and older increased 211% and 101% year-over-year, respectively.
• SUNOSI: Approximately 64,400 prescriptions were written in the U.S., a 15% year-over-year increase and 6% quarter-over-quarter increase.
• SYMBRAVO: Approximately 25,000 prescriptions were written, a 382% year-over-year increase and 7% quarter-over-quarter increase.
• Pipeline Progress: The SUMMIT Phase 3 trial for AXS-05 (smoking cessation) was initiated in August 2026, with topline results anticipated in the second half of 2027.
• Pipeline Progress: The ENGAGE Phase 3 trial for solriamfetol in binge eating disorder reached target enrollment, with topline results expected in the first quarter of 2027.
• Pipeline Progress: The NDA for AXS-12 (narcolepsy) is under FDA review with a PDUFA target action date of May 1, 2027.
• Pipeline Progress: The FOCUS-2 and FOCUS-3 Phase 3 trials for solriamfetol in ADHD are ongoing, with topline results anticipated in the second half of 2027.
• Pipeline Progress: The SUSTAIN Phase 3 trial for solriamfetol in shift work disorder is ongoing, with topline results anticipated in the second half of 2027.
• Pipeline Progress: The CLARITY study for solriamfetol in MDD with EDS symptoms expects enrollment completion in the first half of 2027.
• Pipeline Progress: The FORWARD Phase 3 trial for AXS-14 in fibromyalgia expects enrollment completion in the third quarter of 2027.
• Pipeline Progress: Clinical trials for AXS-17 (epilepsy) and AXS-20 (schizophrenia) are planned to initiate in the first half of 2027.

Market and Competitive Landscape:

• Payer coverage for AUVELITY across all channels is approximately 89% of all lives covered, including 82% of commercial lives and 100% of government lives.
• Payer coverage for SUNOSI across all channels is approximately 82% of all lives covered, including 97% of commercial lives and 59% of government lives.
• Payer coverage for SYMBRAVO across all channels is approximately 57% of all lives covered, including 56% of commercial lives and 57% of government lives.

Risks and Challenges:

• Forward-looking statements highlight risks regarding the commercial success of SUNOSI, AUVELITY, and SYMBRAVO, and the success of efforts to obtain additional indications for solriamfetol and AXS-05.
• Risks include the ability to maintain and expand payer coverage, the success, timing, and cost of ongoing and anticipated clinical trials, and the ability to fund additional clinical trials.
• Risks include the timing and ability to obtain FDA approval, successful defense of intellectual property, and the resolution of intellectual property litigation.
• Risks include market acceptance of products, capital requirements for commercialization, and potential impacts from domestic political climate, geo-political conflicts, or global pandemics.

Management Commentary and Tone:

• CEO Herriot Tabuteau, MD, stated the company delivered 52% year-over-year revenue growth, surpassing a one-billion-dollar annual run rate.
• Management expressed confidence in the industry-leading neuroscience pipeline advancing toward multiple anticipated regulatory and clinical trial milestones.
• The tone emphasized the company's position to deliver innovation targeting significant unmet needs in brain health with the potential to improve millions of lives.

Other Key Points:

• The company hosted a conference call and webcast on November 2, 2026, at 8:00 AM Eastern Time to discuss results.
• The company has an industry-leading neuroscience portfolio addressing over 150 million people in the United States with serious neurological and psychiatric conditions.
• The company is advancing solriamfetol for multiple indications including ADHD, MDD with EDS symptoms, binge eating disorder, and shift work disorder.
• AXS-12 has been granted FDA Orphan Drug designation for narcolepsy.
• AXS-14 is being developed as the SS-enantiomer of reboxetine for fibromyalgia.
• AXS-17 is a novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator.
• AXS-20 is a novel oral, potent, and selective phosphodiesterase 10A (PDE10A) inhibitor.