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Total Q1 revenue for Axsome’s three marketed products was $191 million, up 57% YoY—led by Auvelity net product revenue of $153.2M (+59%) and Sunosi $33.9M (+34%)—with a net loss of $64.5M and $305M in cash, which management says funds operations into cash‑flow positivity under the current plan.
Axsome won FDA approval for Auvelity for agitation associated with Alzheimer’s disease and is preparing a commercial June launch, expanding the salesforce to about 630 reps and achieving roughly 86% payer coverage across channels.
Management raised Auvelity’s peak sales outlook to at least $8 billion and emphasized pipeline momentum, including an NDA filing for AXS‑12 (narcolepsy/cataplexy) and multiple planned or ongoing phase III programs for AXS‑05, solriamfetol, AXS‑14 and AXS‑20.
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Axsome Therapeutics (NASDAQ:AXSM) reported first-quarter 2026 results highlighting strong year-over-year revenue growth, a major new FDA approval for Auvelity, and continued advancement across its neuroscience pipeline. Management also detailed commercial investments to support an upcoming launch in Alzheimer’s disease agitation and provided an updated long-term sales outlook for the Auvelity franchise.
Chief Executive Officer Dr. Herriot Tabuteau said the company delivered “strong year-over-year growth and execution across the business,” citing contributions from its three marketed products and pipeline progress. Total revenue for the three marketed products was $191 million, up 57% versus the first quarter of 2025, driven primarily by Auvelity and Sunosi, with contribution from Symbravo.
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Chief Financial Officer Nick Pizzie reported quarterly net product revenue of $153.2 million for Auvelity, up 59% year-over-year. Sunosi net product revenue was $33.9 million, up 34%, including $32.6 million in net product sales and $1.3 million in royalty revenue in out-licensed territories. Symbravo recorded $4.1 million in net sales.
Pizzie noted gross-to-net discounts for Auvelity and Sunosi were “in the low to mid-50s range,” and he said the company anticipates improvement through the year consistent with prior trends. Symbravo’s gross-to-net was “in the high 70% range,” which he said is expected to remain elevated near term as access evolves and awareness builds.
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Cost of revenue: $14.7 million (vs. $9.8 million in Q1 2025)
R&D: $52.7 million (vs. $44.8 million), with the increase primarily reflecting a “one-time acquisition-related expense”
SG&A: $185.0 million (vs. $120.8 million), driven by pre-launch activities for Auvelity in Alzheimer’s agitation, commercialization activities including a national direct-to-consumer campaign and sales force expansion, and Symbravo commercial activities
Net loss was $64.5 million, or $1.26 per share, compared with a net loss of $59.4 million, or $1.22 per share, in the year-ago quarter. The quarter’s net loss included $23.4 million in stock-based compensation expense. Axsome ended the quarter with $305 million in cash and cash equivalents, down from $323 million at year-end 2025. Pizzie said the company expects its current cash balance “is sufficient to fund our operations into cash flow positivity based on our current operating plan.”
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Tabuteau said the company received FDA approval last week for Auvelity for the treatment of agitation associated with Alzheimer’s disease, an indication that received breakthrough therapy designation and priority review. He called the approval “a first-in-class treatment option” for a “critically underserved” condition and said Auvelity is now approved in two indications that received breakthrough designation and priority review.
Chief Commercial Officer Ari Maizel said the company was “very pleased with the product label,” adding it includes “compelling clinical information regarding Auvelity’s impact on agitation for Alzheimer’s patients.” He described Auvelity as “the only approved treatment for Alzheimer’s disease agitation with efficacy on symptom relapse demonstrated in long-term trials.” Maizel also cited the short-term safety profile discussed on the call, stating that the most common adverse reactions were dizziness and dyspepsia, and that 1.3% of patients discontinued due to an adverse reaction, “the same rate as placebo.”
To support the launch, Maizel said Axsome is expanding the Auvelity sales team to approximately 630 representatives, targeting 68,000 healthcare professionals across primary care, psychiatry, neurology, and geriatrics, including both community and long-term care settings. He said expansion efforts are “substantially complete,” positioning the company for a commercial launch in June. In response to a question about the titration pack dose for the Alzheimer’s agitation indication, management said the titration dose “will be available at the time of commercial launch.”
In Q1, Maizel said more than 223,000 Auvelity prescriptions were written, representing 35% year-over-year growth and remaining consistent with the prior quarter, while the broader antidepressant market grew 1% year-over-year and declined 1% sequentially. He also highlighted shifts in prescribing patterns, including first line/first switch prescriptions increasing to 56% of demand and primary care accounting for 35% of total Auvelity prescribers. Maizel said more than 5,500 new prescribers were activated in the quarter, bringing the cumulative total since launch to approximately 60,000.
On payer access, Maizel said commercial coverage for Auvelity is 78%, and with Medicare and Medicaid coverage at 100%, total coverage is now 86% of all lives across channels.
Maizel said Axsome updated its peak sales outlook for Auvelity following the Alzheimer’s agitation approval and recent commercial investments. He said the company now believes Auvelity “has the potential to generate at least $8 billion in annual revenue at peak,” with “approximately equal contribution” from major depressive disorder and Alzheimer’s disease agitation.
In Q&A, management attributed the revised outlook to greater certainty from the FDA approval, market research and the “clarity around the final label,” expanding primary care adoption, improved market access, and the larger sales force supporting both indications. On the Inflation Reduction Act, Pizzie said that, at the earliest, IRA negotiations would not impact Auvelity until 2031, and added that the $8 billion peak sales figure “contemplates any type of IRA impact.”
Maizel said Symbravo generated more than 17,000 total prescriptions in Q1, representing 36% growth versus Q4 2025, with more than 5,000 new patients starting treatment. He said neurology specialists accounted for about 60% of total writers, with primary care representing about 32%, up from 20% in Symbravo’s first quarter of launch.
Axsome also announced “a major commercial payer contract for Symbravo” effective in April, securing coverage for approximately 17 million lives. Overall payer coverage for Symbravo was about 57% (56% commercial and 57% government). Maizel said Axsome plans to increase the Symbravo sales team by about 50 representatives, bringing the expanded team to 150 representatives.
For Sunosi, Maizel reported approximately 54,000 prescriptions in Q1, up 16% year-over-year but down 3% sequentially. He said payer coverage remained steady at roughly 83% of lives across channels.
Tabuteau said the company submitted an NDA for AXS-12 for the treatment of cataplexy in patients with narcolepsy and is awaiting the FDA’s decision on acceptance of the filing. He described narcolepsy as affecting approximately 185,000 people in the U.S. In discussing AXS-12 amid potential orexin 2 receptor agonist competition, management emphasized patient heterogeneity, polypharmacy, and dissatisfaction with current therapies. Tabuteau said AXS-12 demonstrated onset of action “at 1 week,” durable efficacy with data out to six months, and a favorable side effect profile, and added that data show potential benefits for excessive daytime sleepiness and cognition.
The company also outlined additional development plans:
AXS-05: on track to initiate a pivotal phase II/III trial in smoking cessation in the current quarter
Solriamfetol: phase III programs progressing in ADHD, binge eating disorder, MDD with excessive daytime sleepiness, and shift work disorder; top-line results for the ENGAGE binge eating disorder trial anticipated in the second half of 2026, and shift work disorder results anticipated in 2027
MDD (solriamfetol): initiation of the CLARITY randomized-withdrawal phase III study; management said the design is intended to address placebo response, and noted it anticipates needing two positive trials for approval
AXS-14 (fibromyalgia): enrollment ongoing in the FORWARD phase III trials; management cited prior randomized trials and long-term safety trials with treatment out to at least one year
AXS-17: tech transfer and phase II trial enabling activities underway
AXS-20 (balipodect): a pre-phase III PDE10A inhibitor added to the pipeline for schizophrenia and Tourette syndrome; management said phase III-enabling activities are ongoing with a potential phase III start targeted “around the end of the year,” and cited potential metabolic safety advantages including no observed changes in glucose or prolactin levels in preclinical and clinical studies
Looking ahead, management said the company’s priorities remain focused on growth and commercialization execution. In response to a question on profitability, management said revenue growth is the top priority, followed by reaching cash flow positivity, with profitability “shortly thereafter.”
Axsome Therapeutics, Inc is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for central nervous system (CNS) disorders. The company focuses on small-molecule drugs designed to address unmet medical needs in areas such as depression, migraine, narcolepsy and fibromyalgia. Axsome employs a precision medicine approach, leveraging pharmacologic innovation to target underlying mechanisms of disease and improve patient outcomes.
Axsome's pipeline includes several late-stage and approved product candidates.
The article "Axsome Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat.