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Total 2Q 2025 net product revenue of $150.0 million, representing growth of 72% year-over-year and 24% sequentially
AUVELITY® 2Q 2025 net product sales of $119.6 million, representing growth of 84% year-over-year and 24% sequentially
SUNOSI® 2Q 2025 net product revenue of $30.0 million, representing growth of 35% year-over-year and 19% sequentially
SYMBRAVO® launched June 10th, with 2Q 2025 net product sales of $0.4 million
AUVELITY® market access expanded by 28 million new covered lives in the commercial channel
First group purchasing organization (GPO) contract for SYMBRAVO® signed
Supplemental NDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025
NDA submission for AXS-12 for cataplexy in patients with narcolepsy anticipated in 4Q 2025
Company to host conference call today at 8:00 AM Eastern
NEW YORK, Aug. 04, 2025 (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 second quarter of 2025 and provided a general business update.
“Axsome delivered robust second quarter performance, reflecting strong underlying demand for our life-changing medicines, exacting commercial execution, solid regulatory progress, and continued advancement of our differentiated neuroscience pipeline. We are excited by the recent approval and launch of SYMBRAVO for migraine, and are pleased with the accelerating performance of AUVELITY for depression and SUNOSI for excessive daytime sleepiness,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. “We remain on track to submit new drug applications to the FDA for AXS-05 for Alzheimer’s disease agitation in the third quarter, and for AXS-12 in narcolepsy in the fourth quarter. The rest of our development pipeline is advancing apace, including late-stage programs in ADHD, binge eating disorder, shift work disorder, depression associated with excessive daytime sleepiness, fibromyalgia, and smoking cessation. In total, our portfolio of potentially first-in-class or best-in-class medicines have the potential to address serious conditions that affect more than 150 million patients in the U.S. alone.”
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 dopamine and norepinephrine reuptake inhibitor approved for the treatment of excessive daytime sleepiness in narcolepsy or obstructive sleep apnea.
SYMBRAVO
SYMBRAVO is a novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 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 innovative, late-stage, 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. AXS-05 has been granted FDA Breakthrough Therapy designation for AD agitation.
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), 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-12 has been granted FDA Orphan Drug designation for 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, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine.
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 second quarter 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 (In thousands, except share and per share amounts) | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 303,016 | $ | 315,353 | ||||
| Accounts receivable, net | 198,825 | 142,001 | ||||||
| Inventories, net | 18,441 | 15,732 | ||||||
| Prepaid and other current assets | 16,338 | 11,978 | ||||||
| Total current assets | 536,620 | 485,064 | ||||||
| Equipment, net | 667 | 584 | ||||||
| Right-of-use asset - operating lease | 22,472 | 5,383 | ||||||
| Goodwill | 12,042 | 12,042 | ||||||
| Intangible asset, net | 43,733 | 46,894 | ||||||
| Non-current inventory and other assets | 24,251 | 18,531 | ||||||
| Total assets | $ | 639,785 | $ | 568,498 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 91,628 | $ | 71,997 | ||||
| Accrued expenses and other current liabilities | 170,902 | 147,987 | ||||||
| Operating lease liability, current portion | 337 | 1,835 | ||||||
| Contingent consideration, current | 9,232 | 8,285 | ||||||
| Short-term borrowings | 70,000 | — | ||||||
| Total current liabilities | 342,099 | 230,104 | ||||||
| Contingent consideration, non-current | 79,655 | 91,680 | ||||||
| Loan payable, long-term | 117,540 | 180,710 | ||||||
| Operating lease liability, long-term | 23,624 | 6,046 | ||||||
| Finance lease liability, long-term | 3,792 | 2,943 | ||||||
| Total liabilities | 566,710 | 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, 49,815,301 and 48,667,587 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively) | 5 | 5 | ||||||
| Additional paid-in capital | 1,303,243 | 1,179,797 | ||||||
| Accumulated deficit | (1,230,173 | ) | (1,122,787 | ) | ||||
| Total stockholders’ equity | 73,075 | 57,015 | ||||||
| Total liabilities and stockholders’ equity | $ | 639,785 | $ | 568,498 | ||||
| Axsome Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) | ||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 148,959 | $ | 86,520 | $ | 269,317 | $ | 160,616 | ||||||||
| Royalty revenue | 1,083 | 646 | 2,188 | 1,549 | ||||||||||||
| Total revenues | 150,042 | 87,166 | 271,505 | 162,165 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue (excluding amortization and depreciation) | 13,448 | 8,055 | 23,237 | 14,352 | ||||||||||||
| Research and development | 49,541 | 49,853 | 94,326 | 86,683 | ||||||||||||
| Selling, general and administrative | 130,280 | 103,554 | 251,067 | 202,524 | ||||||||||||
| Loss (Gain) in fair value of contingent consideration | (8,102 | ) | 2,160 | (6,590 | ) | 748 | ||||||||||
| Intangible asset amortization | 1,589 | 1,590 | 3,161 | 3,179 | ||||||||||||
| Total operating expenses | 186,756 | 165,212 | 365,201 | 307,486 | ||||||||||||
| Loss from operations | (36,714 | ) | (78,046 | ) | (93,696 | ) | (145,321 | ) | ||||||||
| Interest expense, net | (1,834 | ) | (1,299 | ) | (4,265 | ) | (2,381 | ) | ||||||||
| Loss on debt extinguishment | (10,385 | ) | — | (10,385 | ) | — | ||||||||||
| Loss before income taxes | (48,933 | ) | (79,345 | ) | (108,346 | ) | (147,702 | ) | ||||||||
| Income tax benefit | 960 | — | 960 | — | ||||||||||||
| Net loss | $ | (47,973 | ) | $ | (79,345 | ) | $ | (107,386 | ) | $ | (147,702 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.97 | ) | $ | (1.67 | ) | $ | (2.18 | ) | $ | (3.11 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 49,442,001 | 47,573,229 | 49,158,159 | 47,482,602 | ||||||||||||
Investors:
Mark Jacobson
Chief Operating Officer
(212) 332-3243
[email protected]
Media:
Darren Opland
Director, Corporate Communications
(929) 837-1065
[email protected]
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