Axsome Therapeutics (NASDAQ:AXSM) reported strong commercial growth in 2025 and outlined several upcoming regulatory and clinical milestones during its fourth quarter and full-year earnings call. Management highlighted expanding revenue contributions from Auvelity and Sunosi, early traction from the Symbravo launch, and a broad CNS pipeline that includes a near-term FDA decision for AXS-05 in Alzheimer’s disease agitation.
Financial results driven by Auvelity, Sunosi, and Symbravo launch
For the fourth quarter, Axsome reported total product revenue of $196 million, an increase of 65% year-over-year. Full-year 2025 product revenue rose 66% to $638.5 million (management also referenced total revenue of $639 million for the year).
- Auvelity net product sales of $155.1 million in Q4, up 68% year-over-year, and $507.1 million for 2025, up 74%, surpassing $500 million in its third full year on the market.
- Sunosi net product revenue of $36.7 million in Q4, up 40%, and $124.8 million for 2025, up 32%.
- Symbravo net sales of $4.1 million in Q4 and $6.6 million for the full year, following its second full quarter of launch.
Chief Financial Officer Nick Pizzie said Auvelity and Sunosi gross-to-net discounts were in the high-40% range in Q4, but are expected to increase to the mid-50% range due to typical first-quarter dynamics. Symbravo gross-to-net discount was in the high-70% range, which management expects to remain elevated during the launch phase.
Axsome posted a Q4 net loss of $28.6 million, or $0.56 per share, compared to a net loss of $74.9 million, or $1.54 per share, in the prior-year quarter. The Q4 net loss included $22.7 million in stock-based compensation. For the full year, net loss was $183.2 million, or $3.68 per share, versus a net loss of $287.2 million, or $5.99 per share, in 2024; the 2025 figure included $93.8 million in stock-based compensation.
Operating expenses reflected ongoing commercial investment. Selling, general, and administrative expenses were $169.3 million in Q4 and $570.6 million for the year, up from $113.3 million and $411.4 million in 2024. Management attributed the increase primarily to commercialization activity for Auvelity— including a sales force expansion and a national direct-to-consumer advertising campaign—along with the Symbravo launch. The company ended 2025 with $323 million in cash and cash equivalents and said it believes its current cash balance is sufficient to fund operations “into cash flow positivity” under its current operating plan.
Commercial update: prescription growth and access efforts
Chief Commercial Officer Ari Maizel said Auvelity recorded more than 225,000 prescriptions in Q4, representing 42% year-over-year growth and 8% sequential growth, while the antidepressant market was flat over the same period. He said more than 5,300 new prescribers were activated in the quarter, bringing the cumulative total to approximately 52,000 unique prescribers since launch. Maizel also emphasized growth in primary care, which he said represented about one-third of prescribers in the quarter and was the fastest-growing segment.
On formulary coverage, management said that as of January 2026, Auvelity commercial coverage increased from 75% to 78%, bringing total coverage to 86% of lives across channels.
Symbravo recorded more than 13,000 total prescriptions in Q4, with approximately 5,300 new patients starting therapy. Axsome said it is executing a “disciplined” launch targeting headache specialists, and reported overall payer coverage of approximately 52% at the start of the year (about 49% commercial and 57% government). The company also said it contracted with a third and final large commercial GPO in Q4, which it described as enabling negotiations with major commercial payers and PBMs.
For Sunosi, Axsome reported more than 54,000 prescriptions in Q4, representing 11% year-over-year growth and 3% sequential growth. Nearly 500 new clinicians prescribed Sunosi in the quarter, bringing the cumulative prescriber base to approximately 15,600 since launch. Payer coverage for Sunosi remained steady at approximately 82% of lives covered across channels. Maizel said Sunosi growth was steady in both obstructive sleep apnea and narcolepsy, with about 70% of prescriptions in excessive daytime sleepiness associated with OSA and 30% in narcolepsy.
Regulatory and pipeline milestones: Alzheimer’s agitation, narcolepsy, and solriamfetol expansion
Chief Executive Officer Herriot Tabuteau said the company’s supplemental NDA for AXS-05 (Auvelity) in Alzheimer’s disease agitation was accepted by the FDA with priority review and a PDUFA action date of April 30. Management said launch readiness activities are underway and noted increasing interest in the treatment community. In Q&A, the company said it expects to be ready to launch within a quarter after the PDUFA date if approved.
Regarding market access for an Alzheimer’s agitation indication, management said coverage generally carries over when a product expands indications, but added that Alzheimer’s agitation is expected to be more Medicare-heavy than major depressive disorder. Pizzie said Axsome anticipates 70%+ of prescriptions for Alzheimer’s agitation could come through Medicare Part D, which he described as having a more favorable gross-to-net profile due in part to no copay card utilization, potentially improving aggregate gross-to-net for Auvelity versus current levels.
For AXS-12 in narcolepsy, Tabuteau said the company expects to submit the NDA “imminently” following positive pre-NDA meeting minutes. In Q&A, management said it anticipates a standard review for the submission. Executives discussed positioning AXS-12 as a potential option in a market where polypharmacy is common, citing interest based on its clinical profile and a favorable safety and tolerability profile.
The company also outlined multiple development programs for solriamfetol across new indications including ADHD, binge eating disorder, major depressive disorder with symptoms of excessive daytime sleepiness, and shift work disorder. Axsome said it reached agreement with the FDA on two planned Phase 3 ADHD studies in pediatric patients—one in children and one in adolescents—with both expected to initiate in the first half of the year. A Phase 3 trial in MDD with excessive daytime sleepiness is expected to initiate this quarter. In binge eating disorder, the Phase 3 trial is ongoing with top-line results expected in the second half of the year. For shift work disorder, management said it now anticipates top-line results in 2027 based on enrollment trends.
Fibromyalgia study and newly acquired AXS-17 program
Axsome said it recently initiated the FORWARD study, a Phase 3 randomized withdrawal trial of AXS-14 in fibromyalgia. Tabuteau said the new study is intended to supplement two completed positive Phase 2 and Phase 3 trials in the indication.
The company also discussed the acquisition of AZD7325, now designated AXS-17, described as a novel oral GABA-A alpha-2/3 receptor positive allosteric modulator. Management said it plans to evaluate AXS-17 for epilepsy based on preclinical seizure models and noted a favorable safety profile in more than 700 patients studied previously in other indications, including generalized anxiety disorder. Axsome said Phase 2 trial-enabling activities are underway and it will provide more detail later on which epilepsy indication it plans to target first.
Commercial investments: sales force expansion and DTC learnings
To support continued Auvelity growth in MDD and prepare for a potential Alzheimer’s agitation launch, Axsome said it initiated its third and largest sales force expansion to approximately 600 sales representatives, with completion expected in the second quarter. Management also said it launched a national TV direct-to-consumer campaign in the September/October timeframe and reported it generated an inflection in new patient starts, with analysis by media channel helping to optimize spending going into 2026.
Executives said they expect continued operating leverage, noting that in 2025 revenues grew roughly three times faster than operating expenses, and indicated the 2026 build for the expanded commercial team had been included in the company’s cash forecast.
About Axsome Therapeutics (NASDAQ:AXSM)
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.
