Axsome Therapeutics, Inc 8-K, filed Nov 2, 2026
Axsome Therapeutics, Inc. (AXSM)
About this 8-K
Axsome Therapeutics, Inc filed this 8-K on November 2, 2026.
Axsome reported 3Q 2026 net product revenue of $259.7 million, up 52% year-over-year, and a net loss of $12.9 million; it initiated the SUMMIT Phase 3 trial of AXS-05 for smoking cessation. AI summary
Items reported
- Item 2.02: Financial results
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
|
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 2, 2026, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended September 30, 2026, and provided an update on the Company’s operations. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information included in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 hereto), shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On November 2, 2026, the Company updated its corporate presentation and posted such corporate presentation to the Company’s website. The updated corporate presentation is filed as Exhibit 99.2 hereto and incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
|
|
Exhibit No. |
|
Description |
|
|
|
99.1 |
|
|
99.2 |
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
Axsome Therapeutics, Inc. |
|
|
|
|
Date: |
November 2, 2026 |
By: |
/s/ Herriot Tabuteau, M.D. |
|
|
Name: Title: |
Herriot Tabuteau, M.D. |
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-over-year growth
SUNOSI® 3Q 2026 net product revenue of $48.2 million, representing 47% year-over-year growth
SYMBRAVO® 3Q 2026 net product sales of $3.9 million, representing 88% year-over-year growth
SUMMIT Phase 3 trial of AXS-05 for smoking cessation initiated
Company to host conference call today at 8:00 AM Eastern Time
NEW YORK, November 2, 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 third quarter of 2026 and provided a general business update.
“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,” said 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.”
Third Quarter 2026 Financial Highlights
1
Financial Guidance
Commercial Highlights
AUVELITY
AUVELITY is a first‑in‑class oral N-methyl-D-aspartate (NMDA) receptor antagonist and sigma‑1 receptor agonist approved in the U.S. for the treatment of major depressive disorder in adults, and for the treatment of agitation associated with dementia due to Alzheimer’s disease.
SUNOSI
SUNOSI is the first and only dopamine and norepinephrine reuptake inhibitor (DNRI) approved for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy.
2
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 product candidates addressing a broad range of 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 NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor being developed for smoking cessation.
Solriamfetol
Solriamfetol is Axsome’s DNRI, TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with EDS symptoms, binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
3
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 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.
AXS-20
AXS-20 (balipodect) is Axsome’s novel oral, potent, and selective phosphodiesterase 10A (PDE10A) inhibitor being developed for the treatment of schizophrenia.
Anticipated Milestones
4
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss its third quarter 2026 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, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates 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.
5
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.
6
Axsome Therapeutics, Inc.
Selected Consolidated Financial Data
Axsome Therapeutics, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
|
|
September 30, |
|
|
December 31, |
|
||
|
|
(Unaudited) |
|
|
|
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
313,859 |
|
|
$ |
322,933 |
|
Accounts receivable, net |
|
|
343,114 |
|
|
|
224,464 |
|
Inventories, net |
|
|
42,579 |
|
|
|
27,938 |
|
Prepaid and other current assets |
|
|
25,084 |
|
|
|
13,651 |
|
Total current assets |
|
|
724,636 |
|
|
|
588,986 |
|
Equipment, net |
|
|
943 |
|
|
|
562 |
|
Right-of-use asset - operating lease |
|
|
18,284 |
|
|
|
20,858 |
|
Goodwill |
|
|
12,042 |
|
|
|
12,042 |
|
Intangible asset, net |
|
|
35,751 |
|
|
|
40,519 |
|
Non-current inventory and other assets |
|
|
35,117 |
|
|
|
26,838 |
|
Total assets |
|
$ |
826,773 |
|
|
$ |
689,805 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
96,075 |
|
|
$ |
65,537 |
|
Accrued expenses and other current liabilities |
|
|
331,756 |
|
|
|
232,853 |
|
Operating lease liability, current portion |
|
|
663 |
|
|
|
434 |
|
Contingent consideration, current |
|
|
11,225 |
|
|
|
10,012 |
|
Short-term borrowings |
|
|
70,000 |
|
|
|
70,000 |
|
Total current liabilities |
|
|
509,719 |
|
|
|
378,836 |
|
Contingent consideration, non-current |
|
|
63,610 |
|
|
|
77,540 |
|
Loan payable, long-term |
|
|
118,069 |
|
|
|
117,746 |
|
Operating lease liability, long-term |
|
|
20,748 |
|
|
|
23,182 |
|
Finance lease liability, long-term |
|
|
9,193 |
|
|
|
4,206 |
|
Total liabilities |
|
|
721,339 |
|
|
|
601,510 |
|
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, 52,576,839 and 50,882,766 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively) |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
1,540,123 |
|
|
|
1,394,251 |
|
Accumulated deficit |
|
|
(1,434,694 |
) |
|
|
(1,305,961 |
) |
Total stockholders’ equity |
|
|
105,434 |
|
|
|
88,295 |
|
Total liabilities and stockholders’ equity |
|
$ |
826,773 |
|
|
$ |
689,805 |
|
7
Axsome Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited)
(In thousands, except share and per share amounts)
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
|
$ |
249,951 |
|
|
$ |
169,784 |
|
|
$ |
655,706 |
|
|
$ |
439,101 |
|
Royalty revenue and milestone revenue |
|
|
9,740 |
|
|
|
1,208 |
|
|
|
13,563 |
|
|
|
3,396 |
|
Total revenues |
|
|
259,691 |
|
|
|
170,992 |
|
|
|
669,269 |
|
|
|
442,497 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of revenue (excluding amortization and depreciation) |
|
|
17,804 |
|
|
|
11,912 |
|
|
|
46,093 |
|
|
|
35,149 |
|
Research and development |
|
|
50,617 |
|
|
|
40,162 |
|
|
|
149,521 |
|
|
|
134,488 |
|
Selling, general and administrative |
|
|
203,111 |
|
|
|
150,235 |
|
|
|
596,244 |
|
|
|
401,302 |
|
Loss (Gain) in fair value of contingent consideration |
|
|
(2,380 |
) |
|
|
13,185 |
|
|
|
(3,286 |
) |
|
|
6,595 |
|
Intangible asset amortization |
|
|
1,607 |
|
|
|
1,607 |
|
|
|
4,768 |
|
|
|
4,768 |
|
Total operating expenses |
|
|
270,759 |
|
|
|
217,101 |
|
|
|
793,340 |
|
|
|
582,302 |
|
Loss from operations |
|
|
(11,068 |
) |
|
|
(46,109 |
) |
|
|
(124,071 |
) |
|
|
(139,805 |
) |
Interest expense, net |
|
|
(1,721 |
) |
|
|
(1,120 |
) |
|
|
(4,446 |
) |
|
|
(5,385 |
) |
Loss on debt extinguishment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(10,385 |
) |
Loss before income taxes |
|
|
(12,789 |
) |
|
|
(47,229 |
) |
|
|
(128,517 |
) |
|
|
(155,575 |
) |
Income tax benefit (expense) |
|
|
(88 |
) |
|
|
— |
|
|
|
(216 |
) |
|
|
960 |
|
Net loss |
|
$ |
(12,877 |
) |
|
$ |
(47,229 |
) |
|
$ |
(128,733 |
) |
|
$ |
(154,615 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.25 |
) |
|
$ |
(0.94 |
) |
|
$ |
(2.48 |
) |
|
$ |
(3.13 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
52,445,193 |
|
|
|
50,021,851 |
|
|
|
51,818,984 |
|
|
|
49,449,220 |
|
Investors:
Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
adong@axsome.com
Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
8
Advancing the frontiers of brain health
Certain matters discussed in this presentation 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 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 presentation, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. This presentation contains statements regarding the Company’s observations based upon the reported clinical data. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other data about the Company's industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Neither we nor any other person makes any representation as to the accuracy or completeness of such data or undertakes any obligation to update such data after the date of this presentation. In addition, these projections, assumptions and estimates are necessarily subject to a high degree of uncertainty and risk. Axsome, AUVELITY, SUNOSI, SYMBRAVO, and MoSEIC are trademarks or registered trademarks of Axsome Therapeutics, Inc. or its affiliates. Except as with respect to AUVELITY and SUNOSI for their approved indications, the development products referenced herein have not been approved by the FDA. 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. Forward looking statements & safe harbor 2
We develop medicines through novel therapeutic approaches to improve the lives of people with serious brain disorders Our mission
BROAD PIPELINE Positioned for significant and durable growth 3 marketed products MDD Migraine AD agitation EDS in OSA or narcolepsy 6 novel product candidates Singular CNS portfolio Psychiatry & Neurology 10 pipeline indications COMMERCIAL Portfolio Psychiatry Neurology Smoking cessation ADHD Binge eating disorder MDD with EDS symptoms Schizophrenia Narcolepsy Fibromyalgia Shift work disorder Epilepsy $8B+ peak sales potential $300M-$500M peak sales potential $500M-$1B peak sales potential
3Q 2026 results COMMERCIAL GROWTH PIPELINE PROGRESS UPCOMING MILESTONES* Net product revenue $259.7M (+52% YoY) >$1 billion annualized revenue run rate Accelerating prescription growth for Alzheimer’s disease agitation, building on continued momentum in MDD AXS-12 NDA under FDA review for cataplexy in narcolepsy Initiated SUMMIT Phase 3 trial of AXS-05 in smoking cessation ENGAGE Phase 3 trial of solriamfetol in binge eating disorder target enrollment reached 7 ongoing Phase 3 trials targeting large and underserved CNS conditions AXS-12 PDUFA target action (May 1, 2027) ENGAGE Phase 3 topline results (1Q 2027) FOCUS-2 and FOCUS-3 Phase 3 topline results (2H 2027) SUMMIT Phase 3 topline results (2H 2027) SUSTAIN Phase 3 topline results (2H 2027) AXS-20 Phase 3 initiation (1H 2027) AXS-17 Phase 1b initiation (1H 2027) *AXS-12: cataplexy in narcolepsy, ENGAGE: solriamfetol in binge eating disorder, FOCUS-2/3: solriamfetol in children and adolescents with ADHD, SUMMIT: AXS-05 in smoking cessation, SUSTAIN: solriamfetol in shift work disorder, AXS-20: schizophrenia, AXS-17: epilepsy
Industry-leading neuroscience pipeline with deep stratification NMDA = N-methyl-D-aspartate; CYP2D6 = Cytochrome P450 Family 2 Subfamily D Member 6; DNRI = Dopamine-norepinephrine reuptake inhibitor; TAAR1 = Trace amine-associated receptor 1; 5-HT = 5-Hydroxytryptamine; NRI = Norepinephrine reuptake inhibitor; GABA = gamma-aminobutyric acid; Please see full Prescribing Information for AUVELITY, SUNOSI, and SYMBRAVO at www.AUVELITY.com, www.SUNOSI.com, and www.SYMBRAVO.com, respectively. Phase 1 Phase 2 Phase 3 NDA AXS-05 (dextromethorphan-bupropion) AXS-12 (reboxetine) AXS-17 Smoking cessation Solriamfetol AXS-14 (esreboxetine) AXS-20 (balipodect) ADHD Binge eating disorder MDD with EDS symptoms Shift work disorder Narcolepsy Fibromyalgia Epilepsy Schizophrenia NMDA antagonist and sigma-1 agonist DNRI and TAAR1 agonist Highly selective NRI and dopamine modulator Highly selective NRI and dopamine modulator GABAA α2,3 subtype-selective PAM Selective PDE10A inhibitor
Advancing new frontiers across 10 serious CNS conditions 1. U.S. Department of Health and Human Services 2020; 2. Hughes JR, et al. 2004; 3. Facts About ADHD in Adults. CDC 2024; 4. Sibley MH, et al. 2022; 5. Hudson JI, et al. 2007; 6. Hein M, et al. 2019; 7. Ringeisen H, et al. 2023; 8. Narcolepsy Network 2024; 9. Swick TJ. 2015; 10. Vincent, et al. 2013; 11. Liu Y, et al. 2016; 12. Sateia MJ. 2014; 13. Alterman T, et al. 2013; 14. Wickwire EM. 2017; 15. Epilepsy CDC 2025; 16. Chen Z, et al. 2018; Psychiatry Shift work disorder 15M+ 0 working Americans may be impacted12-14 new medications approved since 2007 Smoking cessation 34M+ ~70% adults in the U.S. smoke cigarettes1 of smokers say they want to quit2 MDD with EDS symptoms ~50% 0 of MDD patients have concomitant EDS6 FDA-approved treatments ADHD 22M+ >90% people in the U.S. live with ADHD3 of childhood ADHD persists into adulthood4 7M+ people impacted in the U.S.5 Binge eating disorder FDA-approved treatment 1 Epilepsy ~3.4M >1/3 people in the U.S. live with epilepsy15 of patients don’t respond to treatment16 Narcolepsy 185K ~70% people in the U.S. are affected by narcolepsy8 of patients suffer from cataplexy9 >50% people in the U.S. have fibromyalgia10 17M+ Fibromyalgia of patients discontinue treatment in the first year11 Schizophrenia ~3.7M people in the U.S. have schizophrenia and related psychotic disorders7 Neurology
Singular CNS portfolio with >$18B in annual peak sales potential $8B+ $0.5-$1B AXS-17 Epilepsy AXS-20 Schizophrenia Psychiatry Neurology Solriamfetol Shift work disorder $0.3-$0.5B AXS-12 Narcolepsy $0.5-$1B $0.5-$1B AXS-14 Fibromyalgia $0.3-$0.5B Solriamfetol ADHD $1-$3B $0.5-$1B AXS-05 Smoking cessation Solriamfetol Binge eating disorder $0.5-$1B Solriamfetol MDD with EDS $1-$1.5B
Financial highlights
3Q 2026 financial performance 3Q = three months ended September 30; *Includes royalty revenue associated with sales in out-licensed territories and milestone revenue Net product revenue $259.7 $171.0 52% AUVELITY $207.6 $136.1 53% SUNOSI* $48.2 $32.8 47% SYMBRAVO $3.9 $2.1 88% R&D expense $50.6 $40.2 26% SG&A expense $203.1 $150.2 35% 3Q 2026 3Q 2025 % Change $ millions
AUVELITY® quarterly net revenue performance AUVELITY 3Q 2026 net product revenue of $207.6M (53% YoY growth) +53%
SUNOSI 3Q 2026 net product revenue of $48.2M (47% YoY growth) SUNOSI® quarterly net revenue performance +47%
Runway to reach cash flow positivity, based on the current operating plan Financial snapshot Cash balance: (as of September 30, 2026) $313.9M Debt (face value): (as of September 30, 2026) $190M Market cap: (as of October 30, 2026) $7.6B Shares outstanding: (as of September 30, 2026) 52.6M Options, RSUs, and Others outstanding*: 7.8M *Includes 5.6M stock options, 2.0M RSUs, and 0.2M others as of September 30, 2026
Commercial update
Robust commercial portfolio positioned for significant further growth *In approved indications only PEAK SALES POTENTIAL* Accelerating new-to-brand prescription growth Broadening prescriber base and deepening utilization Strong market access Durable demand and high patient satisfaction Multiple label expansion opportunities to expand addressable market Expanding prescriber adoption Broader payer coverage and improving access $8B+ $0.3B-$0.5B $0.5B-$1B HIGHLIGHTS / GROWTH DRIVERS ~$9.5B total commercial opportunity across approved medicines
First and only oral NMDA antagonist and sigma-1 agonist for MDD and Alzheimer’s disease agitation1,2 NMDA = N-methyl-D-aspartate; MDD = Major depressive disorder 1. AUVELITY [Prescribing Information]. Axsome Therapeutics, Inc., New York, NY; 2. Thomas D, Wessel C. BIO 2017; 3. Iosifescu DV, et al. 2022 16 MAJOR DEPRESSIVE DISORDER Only oral antidepressant with rapid-acting efficacy reflected in FDA label1 Rapid symptom improvement starting at week 1 and remission as early as week 2, sustained at week 61,3 Only approved treatment demonstrating substantial symptom improvement and statistically significantly longer time to relapse1 Distinct safety/tolerability profile with no new boxed warning; most common adverse reactions were dizziness and dyspepsia1 Alzheimer’s disease agitation
Continued momentum reflects underlying MDD growth and early impact from the sales force expansion GROWING PRESCRIBER BASE +21% QoQ NBRx growth ~77,000 Unique writers LTD ~89% Total covered lives ~82% Commercial covered lives ~100% Medicare and Medicaid covered lives Accelerating new patient starts STRONG MARKET ACCESS Source: Symphony METYS Total prescriptions (TRx) quarterly +19% QoQ growth in newly activated writers >400,000 Patients treated LTD ~302,000 TRx in 3Q 2026 LTD = launch to date
AUVELITY was approved by the FDA for the treatment of agitation associated with dementia due to Alzheimer’s disease on April 30, 2026 Acceleration in prescription trends among patients aged 65+ following ADA label expansion, alongside continued growth for under 65 FDA approval FDA approval
Continued NBRx acceleration to drive compounding TRx growth FDA approval FDA approval AUVELITY was approved by the FDA for the treatment of agitation associated with dementia due to Alzheimer’s disease on April 30, 2026
First and only dopamine and norepinephrine reuptake inhibitor for EDS associated with narcolepsy or OSA1 First and only wakefulness promoting agent proven to improve wakefulness through 9 hours1 Improvements in cognitive functioning vs. placebo demonstrated in clinical trials 90% of patients reported feeling better with SUNOSI 150 mg2 EDS = Excessive daytime sleepiness; OSA = Obstructive sleep apnea 1. SUNOSI [Prescribing Information]. Axsome Therapeutics, Inc., New York, NY; 2. Schweitzer PK, et al. 2019
Steady demand continues to drive durable growth Source: Symphony METYS. nTRx normalizes number of pills in each TRx for 30-day period. EXPANDING PRESCRIBER reach STEADY DEMAND GROWTH Broad payer COVERAGE >17,500 Unique writers LTD ~64,400 TRx in 3Q 2026 ~114,000 Patients treated LTD ~82% Total covered lives ~97% Commercial covered lives ~59% Medicare and Medicaid covered lives Normalized total prescriptions (nTRx) quarterly LTD = launch to date
Novel, oral, rapidly absorbed, multi-mechanistic approach for the acute treatment of migraine1 Single, oral dose provided rapid migraine pain freedom and return to normal functioning within 2 hours1 Harnesses Axsome’s MoSEIC™ rapid absorption technology to target multiple pathways underlying a migraine attack Superior efficacy demonstrated across a broad range of migraine severity (mild, moderate, severe)1 MoSEIC = Molecular Solubility Enhanced Inclusion Complex; 1. SYMBRAVO [Prescribing Information]. Axsome Therapeutics, Inc., New York, NY
Expanding prescriber and patient adoption Source: Symphony METYS PRESCRIBER GROWTH PATIENT GROWTH market access >25,000 TRx in 3Q 2026 ~24,900 Patients treated LTD ~5,750 Unique writers LTD ~57% Total covered lives ~56% Commercial covered lives ~57% Medicare and Medicaid covered lives Total prescriptions (TRx) quarterly LTD = launch to date
Development pipeline
70% of smokers want to quit2 Only 3-5% of smokers who attempt to quit without assistance are successful for 6-12 months2 Smoking cessation 1. U.S. Department of Health and Human Services 2020; 2. Hughes JR, et al. 2004 Single largest cause of preventable disease and death in the U.S., accounting for nearly 1 in 5 deaths1 Associated with over $300 billion in annual costs in the U.S.1 ~34M adults in the U.S. smoke cigarettes, ~50% of whom live with a smoking-related disease1
Evaluating AXS-05 as a treatment for smoking cessation Key eligibility criteria 18-65 years of age Primary endpoint Change from baseline in smoking abstinence SUMMIT Phase 3 trial 26 AXS-05 Bupropion Placebo 1:1:1 R Screening Double-blind phase (12 weeks) Follow-up Baseline Topline results anticipated 2H 2027
Solriamfetol was initially developed as a dopamine and norepinephrine reuptake inhibitor (DNRI) with wake-promoting effects Preclinical and clinical evidence1,2 suggests TAAR1 plays a role in neuropsychiatric conditions related to the dysregulation of monoaminergic transmission Multimodal activity of solriamfetol selectively inhibits the reuptake of dopamine and norepinephrine and exhibits agonist activity at TAAR1 receptors in the brain Solriamfetol: Unique pharmacology supports potential utility in a broad range of CNS conditions 1. Raony I, et al. 2022; 2. Halff EF, et al. 2023; TAAR1 = Trace amine-associated receptor 1
Solriamfetol Phase 3 development programs ADHD = Attention deficit hyperactivity disorder; MDD = Major depressive disorder; BED = Binge eating disorder; SWD = Shift work disorder ADHD Positive FOCUS Phase 3 trial in adults with ADHD (N=516) Topline data from FOCUS-2 and FOCUS-3 Phase 3 trials in children and adolescents with ADHD anticipated in 2H 2027 Approved in EDS associated with OSA and narcolepsy MDD with EDS BED SWD Ongoing CLARITY Phase 3 trial in MDD with EDS symptoms Topline data from ENGAGE Phase 3 trial in adults with binge eating disorder anticipated in 1Q 2027 Ongoing SUSTAIN Phase 3 trial in adults with shift work disorder (N=450) Topline data anticipated in 2H 2027 Evaluating solriamfetol across four additional indications
Solriamfetol has the potential to treat a broad range of psychiatric and neurological conditions Excessive daytime sleepiness (EDS) in OSA and narcolepsy Approved indication ADHD: ~22M patients Binge eating disorder: ~7M patients Major depressive disorder with EDS symptoms: ~10.5M patients Shift work disorder: ~15M patients Potential label expansion programs
Attention-deficit/hyperactivity disorder (ADHD) 1. Facts About ADHD in Adults. CDC 2024; 2. Data and Statistics on ADHD. CDC 2024; 3. Attention-Deficit/Hyperactivity Disorder. NIMH 2024 Chronic neurobiological and developmental disorder affecting an estimated ~22M people in the U.S.1, including ~7M children aged 3-17 years2 Associated with significant impairment in social, academic, and occupational functioning and development3 Characterized by a persistent pattern of inattention and/or hyperactive-impulsive behaviors3
Significant improvements in overall ADHD severity vs. placebo (CGI-S, p=0.017)c AISRS total score LSM change (±SE) FOCUS Phase 3 Triala AISRS = Adult ADHD Investigator Symptom Rating Scale; LSM = least-squares mean; SE = standard error; SR = sustained release; CGI-S = Clinical Global Impression–Severity scale a. p-values shown for solriamfetol 150 mg are nominal; b. Clinical response defined as ≥30% reduction in AISRS; c. solriamfetol 150 mg; Axsome Therapeutics, Inc. Data on file. 17.7-point reduction in the AISRS total score at Week 6 with solriamfetol vs. 14.3-point reduction with placebo (p=0.039)b Significantly greater percentage of patients receiving solriamfetol achieved a clinical responseb vs. placebo (p=0.024)c Well tolerated with a side effect profile consistent with the established safety profile of solriamfetol Statistically significant improvements in ADHD symptoms with solriamfetol treatment Primary endpoint: Change from baseline in AISRS total score at Week 6 Solriamfetol 300 mg Solriamfetol 150 mg Placebo p=0.036 p=0.041 p=0.039
Solriamfetol Phase 3 program in pediatric ADHD Key eligibility criteria 6 to <12 years of age with diagnosis of ADHD (DSM-5) Primary endpoint Change from baseline in ADHD-RS-5 total score Key eligibility criteria 12 to <18 years of age with diagnosis of ADHD (DSM-5) Primary endpoint Change from baseline in ADHD-RS-5 total score Solriamfetol (dose 1) Solriamfetol (dose 2) Placebo 1:1:1 R Screening (5 weeks) Double-blind phase (6 weeks) Follow-up (1 week) Baseline FOCUS-3 Phase 3 trial N=468 Solriamfetol (dose 1) Solriamfetol (dose 2) Placebo 1:1:1 R Screening (5 weeks) Double-blind phase (6 weeks) Follow-up (1 week) Baseline FOCUS-2 Phase 3 trial N=468 Topline results anticipated 2H 2027 32 ADHD-RS-5 = ADHD Rating Scale
Binge eating disorder 1. Hudson JI, et al. 2007; 2. Swanson SA, et al. 2011; 3. Kessler RM, et al. 2016; 4. McElroy SL, et al. 2020 >7 million people in the U.S. have BED1 BED is 1.75x more common in women than in men1 BED is thought to involve issues with food reward processing, impulse control, cognitive control, and appetite regulation1,3 Unmet medical need associated with a 2- to 3-fold increased risk of psychiatric and medical comorbidities4 Binge eating disorder (BED) is the most common eating disorder, affecting 2.8% of adults and 1.6% of adolescents in the U.S.1,2
Topline results anticipated 1Q 2027 Solriamfetol inhibits the reuptake of dopamine and norepinephrine, neurotransmitters implicated in the pathophysiology of binge eating disorder1-3 Preclinical and clinical data support potential effects of solriamfetol on appetite, food consumption, and weight4,5 1. Giel KE, et al. 2022; 2. Bello NT, Hajnal A. 2010; 3. Pruccoli J, et al. 2021; 4. Malhotra A, et al. 2022; 5. SUNOSI [Prescribing Information]. Axsome Therapeutics, Inc. New York, NY. Solriamfetol (150 mg) Solriamfetol (300 mg) Placebo 1:1:1 R Screening (4 weeks) Double-blind phase (12 weeks) Follow-up (1 week) Baseline ENGAGE Phase 3 trial N=450 Key eligibility criteria 18-55 years of age with diagnosis of BED (DSM-5) Primary endpoint Change from baseline in days with binge eating episodes Solriamfetol for the treatment of binge eating disorder
Shift work has long been associated with multiple serious health complaints and a 23% greater risk of sustaining a work-related injury4-5 No new medications approved since 2007 and considerable residual sleepiness reported when medication is used6 ~15 million U.S. workers may suffer from SWD 10-43% have SWD1,3 Approximately 1 in 3 U.S. workers works an alternate shift2 Shift work disorder (SWD) is a combination of excessive sleepiness during wakefulness and persistent insomnia during daytime sleep when working outside a 7 a.m. to 6 p.m. workday1 Shift work disorder 1. Sateia MJ. 2014; 2. Alterman T, et al. 2013; 3. Wickwire EM. 2017; 4. Smith L, et al. 1994; 5. Akerstedt T, Wright KP. 2009; 6. Czeisler CA, et al. 2005 35
Solriamfetol for the treatment of shift work disorder Key eligibility criteria 18-65 years of age with diagnosis of SWD (ICSD-2 or ICSD-3) Primary endpoint Change from baseline in MWT Placebo Solriamfetol (150 mg) Screening (1-4 weeks) Double-blind phase (up to 12 weeks) Baseline 1:1 R N=450 Follow-up (1 week) SUSTAIN Phase 3 trial Topline results anticipated 2H 2027 MWT = Maintenance of Wakefulness Test 36
MDD with excessive daytime sleepiness (EDS) symptoms 1. Rush AJ, et al. 2006; 2. Major Depression. NIMH 2023; 3. Hasin DS, et al. 2018; 4. Hein M, et al. 2019 Major depressive disorder (MDD) is one of the most common mental disorders in the U.S., impacting ~21M adults each year2,3 Approximately 50% of patients with MDD also experience excessive daytime sleepiness (EDS)4, for which there are no approved treatments MDD patients with EDS have difficulty maintaining wakefulness, resulting in impaired daily functioning and increased safety risks
Placebo Solriamfetol (150 mg) Solriamfetol for the treatment of MDD with EDS symptoms Key eligibility criteria 18-65 years of age with diagnosis of MDD (DSM-5 criteria) Symptoms of excessive daytime sleepiness Double-blind phase Primary endpoint Time from randomization to relapse of depressive symptoms Solriamfetol (150 mg) CLARITY Phase 3 trial Open-label period Baseline 1:1 randomization (Patients achieving treatment response) 38 1:1 R Enrollment completion anticipated 1H 2027
1. Szabo ST, et al. 2019; 2. Krahn LE, Zee PC, Thorpy MJ. 2022; 3. Scammell TE. 2015; 4. Stahl SM, Grady MM. 2003; 5. Burgess CR, Peever JH. 2013; 6. Wu MF, et al. 1999; 7. Bruinstroop E, et al. 2012 Norepinephrine and dopamine play important roles in sleep-wake regulation (both) and in maintaining muscle tone during wakefulness (norepinephrine)1-3 AXS-12 inhibits the reuptake of both neurotransmitters, improving both norepinephrine and cortical dopamine signaling in the brain The loss of orexin input inhibits the production of these neurotransmitters1,2 Decreased norepinephrine signaling is thought to contribute to cataplexy, EDS, and cognitive impairment1,4-7 Decreased dopamine signaling is thought to contribute to EDS and cognitive impairment1,4 AXS-12 (reboxetine) Novel pharmacological approach for the treatment of narcolepsy
Narcolepsy 1. Narcolepsy Network 2024; 2. Sateia MJ. 2014; 3. Narcolepsy. NINDS 2024; 4. España RA, Scammell TE. 2011; 5. Swick TJ. 2015 Rare and debilitating neurological condition that affects approximately 185,000 people in the U.S.1 Characterized by cataplexy, excessive daytime sleepiness (EDS), hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep2-4 Up to 70% of patients suffer from cataplexy, or the sudden reduction or loss of muscle tone while awake5
Rate ratio* p=0.007 p=0.006 p=0.031 p=0.031 p=0.018 p<0.001 p=0.002 *Ratio of change in the AXS-12 group divided by the ratio of change in the placebo group (rate ratio of 1 = no difference) CONCERT SYMPHONY Rapid and robust reductions in cataplexy with AXS-12 treatment PDUFA target action date: May 1, 2027
Adapted from Siracusa, R. et al. 2021 Fibromyalgia pain is thought to be partially caused by dysregulated signaling in the descending analgesic system Norepinephrine, one of the key neurotransmitters in this pathway, has predominantly pain-inhibitory effects AXS-14 is a potent and selective enantiomer of racemic reboxetine that inhibits the reuptake of norepinephrine, resulting in increased norepinephrine activity and decreased pain signaling AXS-14 (esreboxetine) Novel pharmacological approach for the management of fibromyalgia
Fibromyalgia 1. Vincent, et al. 2013; 2. Choy E, et al. 2010; 3. Arnold LM, et al. 2008; 4. Bair MJ, Krebs EE. 2020; 5. Clauw DJ. 2024 Chronic and debilitating neurological pain syndrome resulting from a dysfunction in central pain processing2,3 Characterized by widespread musculoskeletal pain, fatigue, disturbed sleep, mood disturbances, cognitive impairment, and hypersensitivity to sensory stimuli4,5 An estimated ~17 million people in the U.S. are impacted by fibromyalgia1 Associated with substantial physical disability and reduced emotional and social well-being, financial burden, and reduced quality of life2,3
Rapid and robust improvements in fibromyalgia symptoms with AXS-14 treatment Efficacy and safety of AXS-14 compared to placebo evaluated in >1,000 individuals with fibromyalgia across Phase 2 and Phase 3 clinical trials for up to 14 weeks Rapid and significant reductions in pain scores, improvements in patient-reported global functioning, fatigue, and overall symptom severity Baseline * * *** * ** *** *** ** *** *** **** **** **** *** *** **** Baseline * ** *** *** *** ** *** *** ** **** Baseline * * Pain reductiona Phase 3 efficacy results (N=1,122) a. p-values are defined as: *p<0.05, **p<0.01, ***p<0.001, ****p<0.0001
AXS-14 for the management of fibromyalgia Key eligibility criteria ≥18 years of age with diagnosis of fibromyalgia Primary endpoint Time from randomization to loss of therapeutic response FORWARD Phase 3 trial Placebo AXS-14 (8 mg) Open-label period (12 weeks) Double-blind phase (up to 12 weeks) Baseline 1:1 R AXS-14 (8 mg) 1:1 randomization (Patients achieving treatment response) 45 Enrollment completion anticipated 3Q 2027
Epilepsy is a chronic and debilitating neurological disorder affecting ~3.4M people in the U.S.1 1. Epilepsy. CDC 2025; 2. Chen Z, et al. 2018 Despite currently available treatment options, >1/3 of patients do not respond to treatment2 AXS-17 was safe and well tolerated in clinical studies in >700 patients to date and demonstrated compelling anti-convulsant activity in preclinical seizure models Phase 1B initiation in epilepsy anticipated 1H 2027 AXS-17 Novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator (PAM) for epilepsy
~3.7M people in the U.S. have schizophrenia and related psychotic disorders1 1. Ringeisen H, et al. 2023 Completed proof-of-concept Phase 2 trial in patients with schizophrenia AXS-20 demonstrated a favorable safety and tolerability profile in clinical studies in >360 individuals to date Phase 3 initiation in schizophrenia anticipated 1H 2027 AXS-20 Potential first-in-class selective PDE10A inhibitor for neuropsychiatric conditions
Strong intellectual property portfolio AUVELITY AXS-12 SUNOSI AXS-14 SYMBRAVO Protected by a robust patent estate extending to at least 2043, multiple pending Proprietary drug product formulation and methods of treatment Protected by a robust patent estate extending to at least 2042, multiple pending Proprietary drug substance, drug product formulation, and methods of treatment Protected by a robust patent estate extending to at least 2045, multiple pending Proprietary MoSEICTM formulation, drug product formulation, and methods of treatment Orphan Drug Designation Claims extending to at least 2039; 10 issued U.S. patents and 7 issued O.U.S. patents, multiple pending Proprietary drug substance, drug product formulation, and methods of treatment Claims extending to at least 2045; 1 issued U.S. patent, multiple pending Proprietary drug substance, drug product formulation, and methods of treatment
Leadership team Former President, Co-CEO, Director United Therapeutics Corp. Prior positions at Amgen and Burroughs Wellcome Herriot Tabuteau, MD FOUNDER & CEO Management Board of Directors Nick Pizzie, CPA, MBA CHIEF FINANCIAL OFFICER Mark Jacobson, MA CHIEF OPERATING OFFICER Hunter Murdock, JD GENERAL COUNSEL Ari Maizel CHIEF COMMERCIAL OFFICER Mark Saad CEO, NULIDS, LLC Mark Coleman, MD Susan Mahony, PhD Herriot Tabuteau, MD CHAIRMAN Goldman Sachs Bank of America Pierre Fabre – Merck Pfizer - Immucor Stemline Aurobindo – Sun Pharma Kirkland & Ellis LLP AbbVie – Allergan Johnson & Johnson Roger Jeffs, PhD CEO, LIQUIDIA CORPORATION Former COO of the Global Healthcare Group at UBS Former SVP of Eli Lilly and President Lilly Oncology Prior positions at BMS, Amgen and Schering-Plough Medical Director, National Spine and Pain Centers Diplomat of the American Board of Anesthesiology
Thank you. We develop medicines through novel therapeutic approaches to improve the lives of people with serious brain disorders