| Total 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively, representing 65% and 66% year-over-year growth |
| AUVELITY® 4Q and full year 2025 net product sales of $155.1 million and $507.1 million, respectively, representing 68% and 74% year-over-year growth |
| SUNOSI® 4Q and full year 2025 net product revenue of $36.7 million and $124.8 million, respectively, representing 40% and 32% year-over-year growth |
| SYMBRAVO® 4Q and full year 2025 net product sales of $4.1 million and $6.6 million, respectively |
| sNDA for AXS-05 for the treatment of Alzheimer's disease agitation granted Priority Review with PDUFA target action date of April 30, 2026 |
| Acquired AXS-17, a novel oral GABAA α2,3 receptor positive allosteric modulator |
| Company to host conference call today at 8:00 AM Eastern |
NEW YORK, Feb. 23, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced financial results for the fourth quarter and full year 2025 and provided a general business update.
"Our fourth quarter and full year 2025 results demonstrate strong commercial momentum across our marketed products, and advancement and expansion of our innovative CNS pipeline, which now includes five differentiated product candidates," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. "2026 promises to be another eventful year for Axsome with continued commercial execution, and multiple regulatory and clinical milestones including potential FDA action on our sNDA for AXS-05 in Alzheimer's disease agitation, NDA filing for AXS-12 in narcolepsy, and clinical trial progress across our development portfolio."
Fourth Quarter and Full Year 2025 Financial Highlights
Financial Guidance
Commercial Highlights
AUVELITY
AUVELITY is the first and only rapid-acting oral NMDA receptor antagonist and sigma-1 receptor agonist approved in the U.S. for the treatment of major depressive disorder.
SUNOSI
SUNOSI is the first and only DNRI approved for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy.
SYMBRAVO
SYMBRAVO is an oral, rapidly absorbed, multi-mechanistic, COX-2 preferential inhibitor and 5-HT1B/1D agonist approved in the U.S. for the acute treatment of migraine with or without aura in adults.
Development Pipeline
Axsome is advancing an industry-leading neuroscience pipeline of multiple, innovative, patent-protected product candidates addressing serious psychiatric and neurological conditions. Recent and anticipated progress for key pipeline programs is summarized below.
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome's novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor being developed for the treatment of Alzheimer's disease (AD) agitation and smoking cessation.
Solriamfetol
Solriamfetol is Axsome's dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms, binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
AXS-12
AXS-12 (reboxetine) is Axsome's novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy.
AXS-14
AXS-14 (esreboxetine) is Axsome's novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine is the SS-enantiomer of reboxetine.
AXS-17
AXS-17 is Axsome's novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator (PAM) being developed for the treatment of epilepsy.
Corporate Updates
Anticipated Milestones
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss its fourth quarter and full year 2025 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the "Webcasts & Presentations" page of the "Investors" section of the Company's website at axsome.com. A replay of the conference call will be available for approximately 30 days following the live event.
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.
Forward Looking Statements
Certain matters discussed in this press release are "forward-looking statements". The Company may, in some cases, use terms such as "predicts," "believes," "potential," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company's SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company's ability to maintain and expand payer coverage; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund the Company's disclosed clinical trials, which assumes no material changes to the Company's currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application ("NDA") for any of the Company's current product candidates; the Company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration ("FDA") or other regulatory authority approval of, or other action with respect to, the Company's product candidates, including statements regarding the timing of any NDA submission; the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company's ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company's research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company's products and product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway; the Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company's control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
| Axsome Therapeutics, Inc. Selected Consolidated Financial Data |
| Axsome Therapeutics, Inc. Consolidated Balance Sheets (Unaudited, in thousands, except share and per share amounts) | ||||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 322,933 | $ | 315,353 | ||||
| Accounts receivable, net | 224,464 | 142,001 | ||||||
| Inventories, net | 27,938 | 15,732 | ||||||
| Prepaid and other current assets | 13,651 | 11,978 | ||||||
| Total current assets | 588,986 | 485,064 | ||||||
| Equipment, net | 562 | 584 | ||||||
| Right-of-use asset - operating lease | 20,858 | 5,383 | ||||||
| Goodwill | 12,042 | 12,042 | ||||||
| Intangible asset, net | 40,519 | 46,894 | ||||||
| Non-current inventory and other assets | 26,838 | 18,531 | ||||||
| Total assets | $ | 689,805 | $ | 568,498 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 65,537 | $ | 71,997 | ||||
| Accrued expenses and other current liabilities | 232,853 | 147,987 | ||||||
| Operating lease liability, current portion | 434 | 1,835 | ||||||
| Contingent consideration, current | 10,012 | 8,285 | ||||||
| Short-term borrowings | 70,000 | — | ||||||
| Total current liabilities | 378,836 | 230,104 | ||||||
| Contingent consideration, non-current | 77,540 | 91,680 | ||||||
| Loan payable, long-term | 117,746 | 180,710 | ||||||
| Operating lease liability, long-term | 23,182 | 6,046 | ||||||
| Finance lease liability, long-term | 4,206 | 2,943 | ||||||
| Total liabilities | 601,510 | 511,483 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding) | — | — | ||||||
| Common stock, $0.0001 par value per share (150,000,000 shares authorized, 50,882,766 and 48,667,587 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively) | 5 | 5 | ||||||
| Additional paid-in capital | 1,394,251 | 1,179,797 | ||||||
| Accumulated deficit | (1,305,961 | ) | (1,122,787 | ) | ||||
| Total stockholders' equity | 88,295 | 57,015 | ||||||
| Total liabilities and stockholders' equity | $ | 689,805 | $ | 568,498 | ||||
| Axsome Therapeutics, Inc. Consolidated Statements of Operations (Unaudited, in thousands, except share and per share amounts) | ||||||||||||||||
| Three months ended December 31, | Year ended December 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 194,695 | $ | 117,325 | $ | 633,796 | $ | 381,677 | ||||||||
| Royalty revenue and milestone revenue | 1,304 | 1,441 | 4,700 | 4,016 | ||||||||||||
| Total revenues | 195,999 | 118,766 | 638,496 | 385,693 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue (excluding amortization and depreciation) | 12,329 | 10,514 | 47,478 | 33,303 | ||||||||||||
| Research and development | 48,791 | 55,006 | 183,279 | 187,077 | ||||||||||||
| Selling, general and administrative | 169,297 | 113,271 | 570,599 | 411,359 | ||||||||||||
| Loss (Gain) in fair value of contingent consideration | (9,068 | ) | 10,985 | (2,473 | ) | 28,124 | ||||||||||
| Intangible asset amortization | 1,607 | 1,607 | 6,375 | 6,392 | ||||||||||||
| Total operating expenses | 222,956 | 191,383 | 805,258 | 666,255 | ||||||||||||
| Loss from operations | (26,957 | ) | (72,617 | ) | (166,762 | ) | (280,562 | ) | ||||||||
| Interest expense, net | (1,172 | ) | (2,210 | ) | (6,557 | ) | (6,569 | ) | ||||||||
| Loss on debt extinguishment | — | — | (10,385 | ) | — | |||||||||||
| Loss before income taxes | (28,129 | ) | (74,827 | ) | (183,704 | ) | (287,131 | ) | ||||||||
| Income tax benefit (expense) | (430 | ) | (85 | ) | 530 | (85 | ) | |||||||||
| Net loss | $ | (28,559 | ) | $ | (74,912 | ) | $ | (183,174 | ) | $ | (287,216 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.56 | ) | $ | (1.54 | ) | $ | (3.68 | ) | $ | (5.99 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 50,631,337 | 48,541,905 | 49,747,178 | 47,914,253 | ||||||||||||
Investors:
Ashley Dong
Director, Investor Relations
(929) 687-1614
adong@axsome.com
Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
