Axsome Therapeutics (NASDAQ:AXSM) executives highlighted accelerating commercial momentum, a near-term regulatory catalyst, and a broad late-stage pipeline during a presentation at the Citizens JMP Life Sciences Conference.
2025 performance and near-term focus
Chief Operating Officer Mark Jacobson and Chief Financial Officer Nick Pizzie said 2025 marked a year of execution for the company across commercial performance, R&D, and infrastructure. Pizzie said Auvelity surpassed $500 million in revenue in its third year since launch, while total company sales were close to $640 million. Management said the company is preparing for several 2026 catalysts, led by an FDA decision on a supplemental New Drug Application (sNDA) for Auvelity in Alzheimer’s disease agitation.
Commercial portfolio: Auvelity, Sunosi, and SYMBRAVO
Jacobson said Axsome has three on-market products—Auvelity, Sunosi, and SYMBRAVO—two of which were fully developed internally (Auvelity and SYMBRAVO). Management also discussed plans to invest behind these brands while expanding the organization to support potential new indications.
For Auvelity, management emphasized both growth and a major commercial expansion. The company is in the process of doubling its field force, expanding from 300 to 600 representatives, and expects the recruitment to be completed by Q2, ideally before the April 30 PDUFA date. Jacobson noted that Auvelity is currently approved for major depressive disorder (MDD) in adults and described its profile as an oral NMDA receptor antagonist and sigma-1 agonist with rapid and sustained effects and a distinct tolerability profile.
Jacobson said Auvelity utilization has shifted over time toward earlier lines of therapy, with just over 50% of use in first or second line (or first switch). He added that more than 50% of prescriptions are as monotherapy and that primary care prescribing is growing, with primary care representing about a third of prescribers. Despite this, management said Auvelity’s overall share of the total antidepressant market is currently about 0.2%, and the company sees room to expand with increased primary care reach.
On access, management said Auvelity’s covered lives are now 86%, including 78% in the commercial channel and 100% in the government channel—an element they said could be important for an Alzheimer’s disease agitation launch, where they expect most prescriptions to come through government coverage.
Pizzie also pointed to growth trends, saying Auvelity posted 68% year-over-year growth and 74% growth in total annual sales, surpassing $500 million, and noted the company was already annualizing at more than $600 million based on quarterly performance.
For Sunosi, Jacobson said the product continues to grow in its currently approved indications—excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea. Management said Sunosi grew 40% year-over-year in revenue and described pricing impact as positive, while noting the company is also developing solriamfetol (Sunosi’s active ingredient) in additional indications that it believes are more meaningful than the current $300 million to $500 million peak sales opportunity for existing indications.
For SYMBRAVO, launched in June 2025 for the acute treatment of migraine, executives described early script growth and said improving payer coverage is expected to be a key driver going forward. Jacobson said the product uses the company’s MoSEIC technology to drive absorption and is designed for rapid and durable pain relief with a favorable tolerability profile. Pizzie said Axsome is commercializing SYMBRAVO with a relatively small team of roughly 100 representatives, compared with peers that may launch with much larger salesforces.
Pipeline and late-stage clinical programs
Management said Axsome has five differentiated and novel product candidates and is conducting seven phase III clinical trials that are underway or initiating soon. Jacobson and Pizzie framed the company’s opportunity set as spanning 11 different conditions, affecting more than 150 million patients, and said the company has patent protection into the 2040s. Pizzie cited total peak sales potential for targeted conditions as north of $16 billion, while also reiterating previously disclosed peak sales ranges for certain programs, including $1.5 billion to $3 billion for Auvelity in Alzheimer’s disease agitation and $2.5 billion to $6 billion for Auvelity/AXS-05 overall.
Beyond Alzheimer’s disease agitation, Jacobson outlined several pipeline priorities:
- AXS-05 (Auvelity) in smoking cessation: The company plans to launch a phase III trial soon.
- Solriamfetol label expansions: Four phase III programs are ongoing or recently initiated: ADHD, MDD with excessive daytime sleepiness symptoms, binge eating disorder, and shift work disorder. The company said it has already completed a positive phase III trial in adults for ADHD (FOCUS) and plans to launch pediatric trials in children and adolescents.
- AXS-12 (reboxetine) for cataplexy in narcolepsy: Management said an NDA submission is imminent and highlighted the CONCERT and SYMPHONY trials as supporting data. They also noted AXS-12 has Orphan Drug Designation.
- AXS-14 (S-reboxetine) in fibromyalgia: The company recently initiated the FORWARD phase III trial following FDA feedback requesting another fixed-dose, 12-week study.
- AXS-17 (in-licensed program) for epilepsy: The company said 2026 will focus on phase II enabling work, tech transfer, and indication selection.
On timing, the company expects top-line results in the second half of this year from the ENGAGE phase III trial of solriamfetol in binge eating disorder and anticipates top-line results next year from the SUSTAIN phase III trial in shift work disorder. Jacobson added the company has aligned with the FDA that, if SUSTAIN is positive, it expects that study alone could support a potential label expansion due to the condition’s relation to currently approved indications.
Financial position and operating leverage
Pizzie said the company’s development and commercial plans are “fully funded” and described Axsome as being in a strong financial position. He cited $323 million on the balance sheet, which he said is expected to take the company to cash flow positivity, noting the company already delivered a cash flow positive quarter in Q3 2025. He also cited a “small amount of debt” of around $190 million and said the company refinanced its loan from Hercules to Blackstone in the prior year.
Pizzie added that the company is seeing operating leverage, saying revenues grew three times faster than operating expenses in 2025 and that Axsome expects continued operating leverage in 2026, even with planned investment and headcount growth.
Preparation for potential Alzheimer’s disease agitation launch
During Q&A, executives said the expanded 600-representative team will cover both MDD and Alzheimer’s disease agitation call points, with geographies recalibrated accordingly. They also said Axsome plans to add a discrete team focused on long-term care facilities, an area the company has not previously targeted, which they expect will skew toward the Alzheimer’s disease agitation market.
Asked about FDA interactions ahead of the April 30 PDUFA date, Jacobson said the company does not provide real-time updates but indicated that, based on its interactions and visibility into the Division of Psychiatry, “things are where you would expect them to be at this point in the review.” Management also referenced pre-launch preparations, including a non-branded campaign website, ALZgoals.com, and ongoing medical affairs and marketing work.
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.
