Axsome Therapeutics (NASDAQ:AXSM) executives outlined the company’s commercial expansion plans, patent runway and neuroscience pipeline during a presentation at the 46th Annual William Blair Growth Stock Conference.
Chief Operating Officer Mark Jacobson described Axsome as a central nervous system-focused biopharmaceutical company with three marketed products: AUVELITY, SUNOSI and SYMBRAVO. He said the company is focused on “highly differentiated products” in neuroscience, psychiatry and neurology, including recently approved AUVELITY for agitation associated with Alzheimer’s disease.
AUVELITY Growth Outlook Raised After Alzheimer’s Agitation Approval
Pizzie said AUVELITY generated about $153 million in first-quarter sales, representing 59% year-over-year growth. He also said Axsome has expanded its field force from just under 300 representatives to 630 representatives to support growth, particularly as access improves.
According to Pizzie, AUVELITY is now “readily available” for 86% of total U.S. covered lives, including 100% of Medicare Part D lives and 78% of the commercial channel. He said 75% of Medicare Part D covered lives do not require prior authorization or have either unrestricted access or one step.
Jacobson said AUVELITY is being launched this month for agitation associated with Alzheimer’s disease, with the field force beginning education efforts for potential prescribers. He highlighted the drug’s efficacy and tolerability profile, saying the label includes both a parallel group trial and a relapse prevention trial. He said the most common adverse events seen at greater than twice placebo and more than 5% were dizziness and dyspepsia, and noted there is no boxed warning for that patient population.
For major depressive disorder, Jacobson said AUVELITY has shown rapid onset of action, with clinical separation at one week, durable efficacy and a tolerability profile distinct from typical antidepressants. Pizzie added that AUVELITY has only about 22 basis points of total prescription market share in antidepressants while annualizing at roughly $600 million, underscoring what he described as the size of the market opportunity.
SUNOSI Patent Litigation Resolved, SYMBRAVO Access Expands
Jacobson said Axsome announced that all patent litigation related to SUNOSI from first-to-file generic applicants has been resolved, with a generic entry date of September 2040. He also said AUVELITY’s patent situation has already been resolved, with a runway to September 2038 or March 2039 with pediatric exclusivity.
Pizzie said SUNOSI, which Axsome acquired in 2022, generated about $34 million in first-quarter sales, up 34% year over year. He said the company expects a similar quarter-by-quarter trajectory in 2026 to what it saw in 2025 and continues to see peak sales potential of $300 million to $500 million. Jacobson said SUNOSI is approved for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea.
For SYMBRAVO, Axsome’s migraine treatment launched in the back half of last year, Pizzie said prescriptions are growing, with 36% sequential growth. He said the key to unlocking value is payer access, noting that Axsome added 17 million covered lives at the end of the first quarter and is currently at about 56% covered lives in the commercial channel. Pizzie said the company sees peak sales potential for SYMBRAVO of $500 million to $1 billion.
Balance Sheet and Operating Leverage
Pizzie said Axsome ended the first quarter with $305 million in cash, and that current cash on hand is expected to take the company to cash flow positivity and shortly thereafter profitability. He said Axsome has 51.4 million shares outstanding.
First-quarter selling, general and administrative expenses were $185 million, up from $167 million in the fourth quarter, reflecting investment in the AUVELITY team. Pizzie said SG&A is expected to grow further in the second quarter, though not at the same pace, and then “essentially plateau” for the rest of the year as the AUVELITY infrastructure is in place.
Research and development expense was $53 million in the first quarter, including $10 million related to a business development acquisition. Excluding that item, Pizzie said R&D was about $43 million and is expected to move toward the $50 million range in future quarters as additional phase 3 trials begin.
Pipeline Milestones Ahead
Jacobson reviewed several pipeline programs, including additional development for AXS-05, the active ingredient combination in AUVELITY. He said smoking cessation is the first additional indication Axsome has disclosed, with study start-up activities underway.
For solriamfetol, the active ingredient in SUNOSI, Jacobson said Axsome is running development programs in attention-deficit/hyperactivity disorder, binge eating disorder, major depressive disorder with symptoms of excessive sleepiness and shift work disorder. He said top-line results for the binge eating disorder trial are expected later this year, while the shift work disorder phase 3 trial is expected to produce top-line results next year.
Jacobson said Axsome has submitted a new drug application for AXS-12 in narcolepsy with cataplexy and expects to share the FDA’s acceptance decision. He said AXS-14 for fibromyalgia is in an additional phase 3 trial after the FDA requested the agency’s typical two 12-week trial package.
The company also discussed earlier-stage assets, including AXS-17 for epilepsy and AXS-20, a PDE10A inhibitor being developed first for schizophrenia, with phase 3-enabling work underway.
Pizzie said Axsome estimates more than $18 billion in peak sales potential across its commercial and pipeline assets, with more than half of that already tied to commercial products. He said the company expects accelerated revenue growth as it launches AUVELITY in Alzheimer’s agitation and expands use in major depressive disorder, while operating expenses are expected to plateau.
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.
