Results
Total 2Q 2026 net product revenue of $218.4 million, representing 46% year-over-year growth
AUVELITY ® 2Q 2026 net product sales of $180.3 million, representing 51% year-over-year growth
SUNOSI ® 2Q 2026 net product revenue of $35.8 million, representing 20% year-over-year growth
SYMBRAVO ® 2Q 2026 net product sales of $2.3 million
Corporate events
AUVELITY launched for treatment of agitation associated with dementia due to Alzheimer’s disease in June 2026
NDA submission for AXS-12 for cataplexy in narcolepsy accepted by the FDA with PDUFA target action date of May 1, 2027
FOCUS-2 and FOCUS-3 Phase 3 trials of solriamfetol in children and adolescents with ADHD initiated
Management commentary
“The second quarter was highly productive for Axsome.
Our commercial business grew robustly, driven by strong underlying demand for our products, and we made important regulatory and clinical progress across our innovative neuroscience pipeline,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics.
“We expect our commercial momentum to build over the balance of the year, in particular with anticipated continued Auvelity growth in Alzheimer’s disease agitation and major depressive disorder.
With a focus on commercial execution and advancement of our broad late-stage neuroscience pipeline targeting high unmet needs, novel indications, first-in-class mechanisms of action, and best-in-class product profiles, Axsome is well positioned to deliver substantial value to patients and shareholders.”
Results
Second Quarter 2026 Financial Highlights
7Total net product revenue was $218.4 million for the second quarter of 2026, representing 46% year-over-year growth.
Total net product revenue for the comparable period in 2025 was $150.0 million.
3AUVELITY net product sales were $180.3 million for the second quarter of 2026, representing 51% year-over-year growth.
AUVELITY net product sales for the comparable period in 2025 were $119.6 million.
6SUNOSI net product revenue was $35.8 million for the second quarter of 2026, representing 20% year-over-year growth, which consisted of $33.8 million in net product sales, $1.5 million in royalty revenue associated with SUNOSI sales in out-licensed territories, and $0.5 million in milestone revenue.
SUNOSI net product revenue for the comparable period in 2025 was $30.0 million, which consisted of $28.9 million in net product sales and $1.1 million in royalty revenue.
2SYMBRAVO net product sales were $2.3 million for the second quarter of 2026, representing 461% year-over-year growth.
SYMBRAVO was launched in June 2025 and had net product sales of $0.4 million for the second quarter of 2025.
Total cost of revenue was $13.6 million for the second quarter of 2026.
Total cost of revenue for the comparable period in 2025 was $13.4 million.
Research and development (R&D) expenses were $46.2 million for the second quarter of 2026, compared to $49.5 million for the comparable period in 2025.
8The decrease primarily reflects lower costs for AXS-05 and AXS-14.
Selling, general, and administrative (SG&A) expenses were $208.1 million for the second quarter of 2026, compared to $130.3 million for the comparable period in 2025.
The increase primarily reflects commercialization activities for AUVELITY, including the sales force expansion and launch activities for the Alzheimer’s disease agitation indication, and commercialization activities for SYMBRAVO.
Net loss for the second quarter of 2026 was $51.3 million, or $(0.99) per share, compared to a net loss of $48.0 million, or $(0.97) per share, for the comparable period in 2025.
The net loss in the second quarter of 2026 includes $27.1 million in stock-based compensation expense.
Cash and cash equivalents totaled $319.9 million at June 30, 2026, compared to $322.9 million at December 31, 2025.
Shares of common stock outstanding were 52,299,889 at June 30, 2026.
Outlook
Financial Guidance
Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.
Commercial Highlights
Corporate events
AUVELITY
Axsome launched AUVELITY in Alzheimer’s disease agitation in June 2026.
Results
1New-to-brand prescriptions, representing new AUVELITY patient starts, increased 126% among patients ≥65 years of age during the first eight weeks following the Alzheimer’s disease agitation launch compared to the same period in the prior quarter.
New-to-brand prescriptions are considered a leading indicator of growth, reflecting expanding adoption in this patient segment.
These early trends have been accompanied by positive prescriber feedback and recognition of AUVELITY’s differentiated profile in Alzheimer’s disease agitation.
4Overall new-to-brand prescriptions in the second quarter of 2026 increased 26% compared to the first quarter of 2026, reflecting the early impact of the sales force expansion which was completed in the second quarter.
5Approximately 266,000 total prescriptions were written for AUVELITY in the second quarter of 2026, representing year-over-year and quarter-over-quarter increases of 34% and 12%, respectively.
Payer coverage for AUVELITY across all channels is currently at approximately 89% of all lives covered.
The proportion of lives covered in the commercial and government (Medicare and Medicaid) channels are approximately 82% and 100%, respectively.
Corporate events
SUNOSI is the first and only DNRI approved for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy.
Results
Approximately 61,000 prescriptions were written for SUNOSI in the U.S. in the second quarter of 2026, a 14% increase compared to the same period in 2025, and an 8% increase compared to the first quarter of 2026.
Payer coverage for SUNOSI across all channels is at approximately 82% of all lives covered, including approximately 96% of commercial lives and 59% of government lives.
Approximately 23,500 prescriptions were written for SYMBRAVO in the second quarter of 2026, a 30% increase compared to the first quarter of 2026.
Payer coverage for SYMBRAVO across all channels is at approximately 57% of all lives covered, including approximately 56% of commercial lives and 57% of government lives.
Management commentary
The previously announced expansion of the SYMBRAVO sales force is substantially complete.
Our expanded sales team of approximately 150 sales representatives will enable broader reach within the primary care market and deeper engagement with headache specialists and neurologists nationwide.
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
Outlook
Smoking Cessation: Axsome is on track to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in the third quarter of 2026.
Corporate events
Solriamfetol
Attention Deficit Hyperactivity Disorder: In June and July 2026, Axsome initiated the FOCUS-3 and FOCUS-2 Phase 3, randomized, double-blind, placebo-controlled, multicenter trials evaluating the efficacy and safety of solriamfetol as a treatment for adolescents and children with ADHD, respectively.
The primary endpoint in both studies is the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score.
Major Depressive Disorder: Axsome is conducting the CLARITY study, a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial evaluating the efficacy and safety of solriamfetol for the treatment of MDD with EDS symptoms.
Outlook
Binge Eating Disorder: Axsome is conducting the ENGAGE study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in BED.
The Company anticipates topline results from the ENGAGE Phase 3 trial in the fourth quarter of 2026.
Shift Work Disorder: Axsome is conducting the SUSTAIN study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in SWD in adults.
The Company anticipates topline results from the SUSTAIN Phase 3 trial in 2027.
Corporate events
Narcolepsy: Axsome’s NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy was accepted by the FDA and assigned a PDUFA target action date of May 1, 2027.
Fibromyalgia: Axsome is conducting the FORWARD study, a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial evaluating the efficacy and safety of AXS-14 for the management of fibromyalgia.
Management commentary
Epilepsy: Phase 2 trial-enabling activities for AXS-17 in epilepsy are underway.
Schizophrenia: Phase 3 trial-enabling activities for AXS-20 in schizophrenia are underway.
Tourette Syndrome: Axsome plans to evaluate AXS-20 as a potential treatment for Tourette syndrome.
Outlook
Anticipated Milestones
Clinical Trial Initiations and Progress:
Corporate events
Phase 2/3 trial of AXS-05 in smoking cessation, initiation (3Q 2026)
Results
Clinical Trial Topline Results:
Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (4Q 2026)
Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2027)
Regulatory and Commercial:
Corporate events
AXS-12 for narcolepsy, PDUFA target action (May 1, 2027)
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