Axsome Therapeutics (NASDAQ:AXSM) executives outlined the company’s commercial strategy for AUVELITY following its recent approval for Alzheimer’s disease agitation, while also highlighting continued growth plans across its depression, migraine and sleep-disorder franchises during a Goldman Sachs conference session hosted by analyst Richard Law.
Axsome’s chief operating officer, Mark, described the company as a CNS-focused biopharmaceutical business with three marketed products: AUVELITY, SYMBRAVO for migraine and SUNOSI for excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy. He said AUVELITY, which targets NMDA and sigma-1, had previously been approved for major depressive disorder and is now being launched this month for Alzheimer’s disease agitation.
AUVELITY Label and Peak Sales Outlook
Asked about the factors behind Axsome’s updated $8 billion peak sales expectation for AUVELITY, Mark pointed to the product’s label and clinical profile. He said most treatments currently used for Alzheimer’s disease agitation are prescribed off-label, while AUVELITY is mechanistically distinct from historical treatment options.
Mark said AUVELITY showed rapid onset of effect in a typical longitudinal study, with separation beginning at week two and statistical significance at week three, continuing through the endpoint. He also cited a long-term efficacy trial included in the label, saying patients were treated for up to a year, and in some cases longer, with durable treatment effect and no increase in adverse reactions over time.
On safety, Mark said the most common adverse reactions were dizziness and dyspepsia. He said the company did not observe sedation, falls, mortality or tardive dyskinesia signals in the data discussed.
Nick Pizzie, Axsome’s chief financial officer, said the company’s reassessment also reflected AUVELITY’s trajectory in major depressive disorder. He said AUVELITY has about 22 basis points of the overall antidepressant market, while new-to-brand prescriptions represent about 0.4%, which he described as a leading indicator for future total prescription trends.
Pizzie said Axsome expanded its sales force from just under 300 representatives to more than 600, and since May 1 has seen new-to-brand prescriptions rise from about 2,700 to roughly 3,200 per week. He said the company has achieved more than $600 million in annualized sales for AUVELITY with limited direct-to-consumer advertising and a smaller field force compared with peers.
Coverage and Gross-to-Net Expectations
Pizzie said AUVELITY’s payer coverage stands at 86% of total covered lives, including 100% in the government channel and 78% in the commercial channel. For the major depressive disorder indication, he said prescriptions are currently about 70% commercial, 15% Medicare and 15% Medicaid.
For Alzheimer’s disease agitation, Axsome expects more than 80% of prescriptions to be covered under Medicare Part D, with the remainder mostly split between commercial coverage and some Medicaid, according to Pizzie.
On gross-to-net expectations, Pizzie said Axsome expects the current year to follow a similar trajectory to prior years, with a weaker first quarter and improvement through the year. He said the company started this year in the low 50s compared with the mid-50s in the prior year and expects a similar trajectory for 2026. He added that the Alzheimer’s disease agitation indication is not expected to negatively affect gross-to-net and could strengthen improvement over the next several years.
Sales Force Expansion and Launch Strategy
Axsome said its commercial launch for AUVELITY in Alzheimer’s disease agitation is on track this month. Pizzie said the company’s expanded sales force is now largely in place and has already been detailing AUVELITY for depression. Training for the Alzheimer’s disease agitation indication has been underway since the approval at the end of April, and representatives are beginning to discuss both indications in the field.
The company said it is using smaller sales territories and overlapping representatives to increase physician reach and frequency. Pizzie said Axsome is now able to target higher-decile doctors more frequently, including once or twice per week in some cases.
Axsome is also deploying a smaller team focused on long-term care facilities. Pizzie said this marks the first time Axsome has called on long-term care facilities, and the effort will cover both Alzheimer’s disease agitation and major depressive disorder because of prevalence and comorbidity in those settings.
On direct-to-consumer advertising, Pizzie said Axsome began mass-media efforts for depression in the fourth quarter of last year and continued some activity in the first quarter. For Alzheimer’s disease agitation, however, he said the company does not expect a television advertisement this year, preferring first to educate physicians before potentially considering consumer advertising in 2027 or 2028.
Pipeline and Other Products
Mark said SYMBRAVO, Axsome’s migraine product, is approaching the first anniversary of its launch and that the company continues to invest in the product and expects growth. He also described SUNOSI as a “very healthy business” with steady growth.
Looking ahead, Mark said the next potential commercial asset is AXS-12 for narcolepsy. Axsome has submitted a new drug application for the program and is awaiting the FDA’s acceptance decision. He also highlighted upcoming clinical trial activity, including solriamfetol in binge eating disorder later this year, planned trials in ADHD and ongoing studies in major depressive disorder with excessive sleepiness symptoms.
Asked about expansion outside the United States, Mark said Axsome remains focused on the U.S. business while considering partnerships where appropriate. He noted that the company already has an ex-U.S. partner for SUNOSI and continues to work through development activities tied to differing regulatory requirements in other markets.
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.
