Key Highlights

  • AXSM reported third quarter Revenue of $259.7 million, up from $171.0 million a year earlier.
  • Auvelity net sales reached $207.6 million, compared with $136.1 million in the third quarter of 2025.
  • Net loss narrowed to $12.9 million, or $0.25 per share, from $47.2 million, or $0.94 per share.
  • Selling, general and administrative expenses rose to $203.1 million from $150.2 million.
  • Cash and cash equivalents were $313.9 million at Sep 30, 2026.

Auvelity Alzheimer's Agitation Launch Lifts Quarterly Revenue to $259.7 Million

Axsome Therapeutics (NASDAQ:AXSM) reported results for the quarter ended Sep 30, 2026 on Nov 2, 2026. Total revenue was $259.7 million versus $171.0 million a year earlier, and net product sales were $250.0 million versus $169.8 million. Management said the commercial portfolio has passed a $1 billion annualized revenue run-rate.

Axsome is a New York biopharmaceutical company that markets treatments for central nervous system conditions. Auvelity, approved for major depressive disorder and, since June 2026, for agitation associated with Alzheimer's disease, produced $207.6 million of sales, up from $136.1 million.

Sunosi net sales were $38.5 million, compared with $31.6 million, and Symbravo, a migraine treatment launched in June 2025, contributed $3.9 million versus $2.1 million. Royalty and milestone revenue rose to $9.7 million from $1.2 million, including an $8.5 million sales-based milestone tied to Sunosi sales outside the United States.

Prescription Growth and Prescriber Gains Behind the Auvelity Ramp

Management said Auvelity total prescriptions reached about 302,000 in the quarter, up 40% year over year and 14% from the prior quarter, against antidepressant market growth of 3% and 2%. Among patients aged 65 and older, which mainly reflects Alzheimer's agitation, new-to-brand prescriptions grew 211% year over year and total prescriptions rose 101%.

About 8,200 new prescribers were activated, bringing the total to roughly 77,000. Primary care made up nearly 40% of prescribers and 25% of prescriptions. Management said Auvelity coverage stood at about 89% of insured lives, and it sees peak annual revenue potential of at least $8 billion.

Management said the gross-to-net discount on Auvelity improved to the mid to high 40s percent range from about 50% in the second quarter. It expects a slight increase in the fourth quarter due to typical seasonality, and a 2027 level similar to 2026.

Spending on Launches Keeps Loss at $12.9 Million Despite 52% Sales Growth

Selling, general and administrative expenses were $203.1 million, up from $150.2 million, reflecting the Alzheimer's agitation launch, a national direct-to-consumer campaign and sales force expansion. Research and Development spending rose to $50.6 million from $40.2 million, led by solriamfetol and AXS-14 programs.

Net loss narrowed to $12.9 million from $47.2 million and included $26.4 million of stock-based compensation. For the nine months, the net loss was $128.7 million versus $154.6 million, while operating cash use was $63.1 million versus $74.8 million.

Cash stood at $313.9 million, compared with $323 million at year end 2025. Outstanding borrowings under its Credit agreement were $120.0 million of term loans and $70.0 million on the revolver, and management expects current cash to fund operations until the company turns Cash Flow positive.

Binge Eating Disorder Readout and May 2027 FDA Date Anchor the Pipeline

The pipeline includes 10 programs. Topline results from the Phase III ENGAGE trial of solriamfetol in binge eating disorder are expected in the first quarter of 2027, and the FDA has set a May 1, 2027 target action date for AXS-12 in cataplexy associated with narcolepsy. Phase III results for smoking cessation and ADHD studies are expected in the second half of 2027, and management expects SG&A to rise only marginally through the end of 2026.