Axsome Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update
Axsome Therapeutics, Inc. (AXSM) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Axsome Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update Total 3Q 2026 net product revenue of $259.7 million, representing 52% year-over-year growth AUVELITY ® 3Q 2026 net product sales of $207.6 million, representing 53% year-ove
How this was made
The 30-second read
Why it matters
The earnings beat and narrowed loss provide a catalyst for short‑term price appreciation, while upcoming Phase 3 data could drive longer‑term moves.
Market read
First‑report earnings for a micro‑cap biotech; material for traders tracking CNS drug pipelines.
What to watch
Milestone revenue and royalty streams are small; upcoming trial results (AXS‑05) remain uncertain.
Total 3Q 2026 net product revenue of $259.7 million, representing 52% year-over-year growth; net loss narrowed to $12.9 million, or $(0.25) per share.
Total net product revenue grew 52% year over year, led by AUVELITY, while net loss narrowed from $47.2 million to $12.9 million. The company continued to invest in commercialization and clinical development and stated that current cash is sufficient to fund anticipated operations into cash flow positivity.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Total revenues, three months ended September 30, 2026GAAP | $259.7M | – | 52% |
| Product sales, net, three months ended September 30, 2026GAAP | $250.0M | – | – |
| Royalty revenue and milestone revenue, three months ended September 30, 2026GAAP | $9.74M | – | – |
| Cost of revenue (excluding amortization and depreciation), three months ended September 30, 2026GAAP | $17.80M | – | – |
| Research and development, three months ended September 30, 2026GAAP | $50.62M | – | – |
| Selling, general and administrative, three months ended September 30, 2026GAAP | $203.1M | – | – |
| Loss (Gain) in fair value of contingent consideration, three months ended September 30, 2026GAAP | −$2.38M | – | – |
| Intangible asset amortization, three months ended September 30, 2026GAAP | $1.61M | – | – |
| Total operating expenses, three months ended September 30, 2026GAAP | $270.8M | – | – |
| Loss from operations, three months ended September 30, 2026GAAP | −$11.07M | – | – |
| Interest expense, net, three months ended September 30, 2026GAAP | −$1.72M | – | – |
| Loss before income taxes, three months ended September 30, 2026GAAP | −$12.79M | – | – |
| Income tax benefit (expense), three months ended September 30, 2026GAAP | −$88K | – | – |
| Net loss, three months ended September 30, 2026GAAP | −$12.88M | – | – |
| Net loss per common share, basic and diluted, three months ended September 30, 2026GAAP | $ (0.25 ) | – | – |
| Weighted average common shares outstanding, basic and diluted, three months ended September 30, 2026GAAP | 52,445,193 | – | – |
| Total revenues, nine months ended September 30, 2026GAAP | $669.3M | – | – |
| Product sales, net, nine months ended September 30, 2026GAAP | $655.7M | – | – |
| Royalty revenue and milestone revenue, nine months ended September 30, 2026GAAP | $13.56M | – | – |
| Cost of revenue (excluding amortization and depreciation), nine months ended September 30, 2026GAAP | $46.09M | – | – |
| Research and development, nine months ended September 30, 2026GAAP | $149.5M | – | – |
| Selling, general and administrative, nine months ended September 30, 2026GAAP | $596.2M | – | – |
| Loss (Gain) in fair value of contingent consideration, nine months ended September 30, 2026GAAP | −$3.29M | – | – |
| Intangible asset amortization, nine months ended September 30, 2026GAAP | $4.77M | – | – |
| Total operating expenses, nine months ended September 30, 2026GAAP | $793.3M | – | – |
| Loss from operations, nine months ended September 30, 2026GAAP | −$124.1M | – | – |
| Interest expense, net, nine months ended September 30, 2026GAAP | −$4.45M | – | – |
| Loss on debt extinguishment, nine months ended September 30, 2026GAAP | $ — (in thousands) | – | – |
| Loss before income taxes, nine months ended September 30, 2026GAAP | −$128.5M | – | – |
| Income tax benefit (expense), nine months ended September 30, 2026GAAP | −$216K | – | – |
| Net loss, nine months ended September 30, 2026GAAP | −$128.7M | – | – |
| Net loss per common share, basic and diluted, nine months ended September 30, 2026GAAP | $ (2.48 ) | – | – |
| Weighted average common shares outstanding, basic and diluted, nine months ended September 30, 2026GAAP | 51,818,984 | – | – |
| Cash and cash equivalents at September 30, 2026GAAP | $313.9M | – | – |
| Short-term borrowings at September 30, 2026GAAP | $70M | – | – |
| Loan payable, long-term at September 30, 2026GAAP | $118.1M | – | – |
| Shares of common stock outstanding at September 30, 2026GAAP | 52,576,839 | – | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| AUVELITYApproximately 302,000 total prescriptions were written for AUVELITY in the third quarter of 2026. New-to-brand prescriptions increased by 44% year-over-year and 21% quarter-over-quarter. | $207.6M | – | 53% |
| SUNOSIRevenue consisted of $38.5 million in net product sales, $1.2 million in royalty revenue associated with SUNOSI sales in out-licensed territories, and $8.5 million in milestone revenue. Approximately 64,400 prescriptions were written in the U.S. in the third quarter of 2026. | $48.2M | – | 47% |
| SYMBRAVOApproximately 25,000 prescriptions were written for SYMBRAVO in the third quarter of 2026, a 382% increase compared to the same period in 2025 and a 7% increase compared to the second quarter of 2026. | $3.9M | – | 88% |
Amounts quoted below without a unit are in thousands, as in the filing’s tables. Per-share figures are as printed.
Current operating plan outlook
- NoteAxsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.
- NoteThe Company anticipates topline results from the ENGAGE Phase 3 trial of solriamfetol in binge eating disorder in the first quarter of 2027.
- NoteThe PDUFA target action date for AXS-12 for cataplexy in narcolepsy is May 1, 2027.
- NoteThe Company anticipates topline results from the SUSTAIN, FOCUS-2, FOCUS-3, and SUMMIT Phase 3 trials in the second half of 2027.
What drove it
- AUVELITY total prescriptions were approximately 302,000, with year-over-year and quarter-over-quarter increases of 40% and 14%, respectively.
- AUVELITY new-to-brand prescriptions increased by 44% year-over-year and 21% quarter-over-quarter.
- AUVELITY payer coverage across all channels was approximately 89% of all lives covered, including approximately 82% of commercial lives and 100% of government lives.
- SUNOSI prescriptions were approximately 64,400 in the U.S., a 15% increase compared to the same period in 2025 and a 6% increase compared to the second quarter of 2026.
- SUNOSI payer coverage across all channels was approximately 82% of all lives covered, including approximately 97% of commercial lives and 59% of government lives.
- SYMBRAVO payer coverage across all channels was approximately 57% of all lives covered, including approximately 56% of commercial lives and 57% of government lives.
- The increase in R&D expense primarily reflected costs for the ongoing clinical programs for solriamfetol, AXS-14, and AXS-05.
- The increase in SG&A expense primarily reflected commercialization activities for AUVELITY and SYMBRAVO.
Concerns
- The company reported a net loss of $ (12,877 ) (in thousands) for the third quarter of 2026 and $ (128,733 ) (in thousands) for the nine months ended September 30, 2026.
- SG&A expense was $ 203,111 (in thousands) in the third quarter of 2026, compared to $ 150,235 (in thousands) in the comparable 2025 period.
- SUNOSI net product revenue included $8.5 million in milestone revenue.
- SYMBRAVO payer coverage was approximately 57% of all lives covered.
- The company identified risks related to commercial success, payer coverage, clinical trial timing and costs, regulatory approvals, intellectual property, capital requirements, and the ability to convert sales to recognized revenue and maintain a favorable gross to net sales.
What to watch
- Phase 3 ENGAGE topline results for solriamfetol in binge eating disorder anticipated in the first quarter of 2027.
- AXS-12 PDUFA target action date of May 1, 2027 for cataplexy in narcolepsy.
- Planned initiation of a Phase 1B trial of AXS-17 in epilepsy and a Phase 3 trial of AXS-20 in schizophrenia in the first half of 2027.
- Anticipated second-half 2027 topline results for the SUSTAIN, FOCUS-2, FOCUS-3, and SUMMIT Phase 3 trials.
- AUVELITY demand trends, including new-to-brand prescriptions and utilization among patients aged 65 years and older.
- Payer coverage progression for SYMBRAVO and SUNOSI.
Balance sheet and cash flow
- Cash and cash equivalents were $ 313,859 (in thousands) at September 30, 2026, compared to $ 322,933 (in thousands) at December 31, 2025.
- Accounts receivable, net were $ 343,114 (in thousands) at September 30, 2026, compared to $ 224,464 (in thousands) at December 31, 2025.
- Inventories, net were $ 42,579 (in thousands) at September 30, 2026, compared to $ 27,938 (in thousands) at December 31, 2025.
- Total current assets were $ 724,636 (in thousands) at September 30, 2026, compared to $ 588,986 (in thousands) at December 31, 2025.
- Total assets were $ 826,773 (in thousands) at September 30, 2026, compared to $ 689,805 (in thousands) at December 31, 2025.
- Accounts payable were $ 96,075 (in thousands) at September 30, 2026, compared to $ 65,537 (in thousands) at December 31, 2025.
- Accrued expenses and other current liabilities were $ 331,756 (in thousands) at September 30, 2026, compared to $ 232,853 (in thousands) at December 31, 2025.
- Short-term borrowings were $ 70,000 (in thousands) at September 30, 2026 and $ 70,000 (in thousands) at December 31, 2025.
- Loan payable, long-term was $ 118,069 (in thousands) at September 30, 2026, compared to $ 117,746 (in thousands) at December 31, 2025.
- Total liabilities were $ 721,339 (in thousands) at September 30, 2026, compared to $ 601,510 (in thousands) at December 31, 2025.
- Total stockholders’ equity was $ 105,434 (in thousands) at September 30, 2026, compared to $ 88,295 (in thousands) at December 31, 2025.
- No operating cash flow, free cash flow, or capital-return activity was reported in the filing.
Analysis
Axsome reported third-quarter total revenues of $ 259,691 (in thousands), compared with $ 170,992 (in thousands) in the comparable 2025 period. The release characterized total net product revenue as $259.7 million and 52% year-over-year growth. AUVELITY was the principal revenue contributor at $207.6 million in net product sales, while SUNOSI contributed $48.2 million of net product revenue and SYMBRAVO contributed $3.9 million of net product sales.
Commercial indicators were positive across the portfolio. AUVELITY recorded approximately 302,000 total prescriptions, with increases of 40% year over year and 14% quarter over quarter. New-to-brand prescriptions increased by 44% year over year and 21% quarter over quarter. SUNOSI prescriptions reached approximately 64,400 in the U.S., while SYMBRAVO prescriptions reached approximately 25,000. AUVELITY payer coverage was approximately 89% of all lives covered, compared with approximately 82% for SUNOSI and approximately 57% for SYMBRAVO.
The company materially narrowed its GAAP quarterly net loss to $ (12,877 ) (in thousands), or $ (0.25 ) per basic and diluted common share, from $ (47,229 ) (in thousands), or $ (0.94 ), in the comparable period. Cost of revenue, R&D, and SG&A all increased. R&D rose to $ 50,617 (in thousands), with the increase primarily tied to ongoing solriamfetol, AXS-14, and AXS-05 clinical programs. SG&A rose to $ 203,111 (in thousands), primarily reflecting commercialization activities for AUVELITY and SYMBRAVO.
Cash and cash equivalents were $ 313,859 (in thousands) at September 30, 2026, compared with $ 322,933 (in thousands) at December 31, 2025. The company also reported $ 70,000 (in thousands) of short-term borrowings and $ 118,069 (in thousands) of long-term loan payable. Axsome stated that current cash is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan. The filing did not provide operating cash flow or free cash flow.
The pipeline provides several defined 2027 events. ENGAGE topline results in binge eating disorder are anticipated in the first quarter of 2027, and the AXS-12 PDUFA target action date is May 1, 2027. The company also expects several Phase 3 topline results in the second half of 2027, including SUSTAIN, FOCUS-2, FOCUS-3, and SUMMIT. The release did not provide revenue, expense, margin, or tax-rate guidance.
Management, verbatim
Axsome delivered 52% year-over-year total revenue growth in the third quarter, surpassing a one-billion-dollar annual run rate. We expect 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.
Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics
Our industry-leading neuroscience pipeline continued to advance, leading to multiple anticipated regulatory and clinical trial milestones in the coming quarters. Our commercial and research and development performance positions us to continue to deliver innovation targeting significant unmet needs in brain health, with the potential to improve the lives of millions of patients.
Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics
Not in the filing
stated, not guessed- Gross margin was not reported.
- Non-GAAP financial measures, including non-GAAP operating income, non-GAAP net income, and non-GAAP EPS, were not reported.
- Operating cash flow and free cash flow were not reported.
- Capital returns, including share repurchases and dividends, were not reported.
- A total debt figure was not reported. Short-term borrowings and long-term loan payable were reported separately.
- Formal revenue, gross-margin, operating-expense, and tax-rate guidance was not reported.
- Prior-quarter financial statement comparison figures were not reported.
- A prior-year balance-sheet comparison as of September 30, 2025 was not reported. The balance-sheet comparator was December 31, 2025.
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was checked against the filing text, and a metric whose value, prior period and change do not add up is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
Axsome Therapeutics (NASDAQ:AXSM) released its Q3 2026 earnings via an SEC Form 8‑K, detailing product sales, R&D spend, and pipeline updates.
Ticker impact
Axsome Therapeutics filed an 8‑K reporting Q3 2026 results with 52% YoY revenue growth and a narrowed net loss.
likely upside as investors price in accelerated revenue growth and narrowing losses
Quarterly numbers exceed prior expectations; guidance implies cash runway to profitability.
Market effects
Highlights momentum in CNS biotech sector, may lift peers with similar pipelines.
Positive for US biotech listings, modest effect on broader Nasdaq.
Limited to investors focused on specialty pharma; no broad macro impact.
Counterpoint
Revenue growth may be unsustainable if payer coverage stalls; high cash burn could pressure valuation.
Key entities
- companyAxsome Therapeutics
Biopharmaceutical company focused on CNS disorders.
