Axsome Therapeutics Tops $1 Billion Revenue Run Rate as AUVELITY Sales Surge

Key Points

• Axsome reported $260 million in third-quarter revenue, reaching an annualized run rate above $1 billion for the first time. AUVELITY contributed $208 million, up 53% year over year.
• AUVELITY prescription growth is accelerating: weekly new-to-brand prescriptions rose from 2,400 in Q1 to 3,550 in Q3 and were tracking at 3,800 in October. Axsome has also expanded its sales force to about 650 representatives.
• Axsome is advancing a 10-program pipeline, with an FDA decision on AXS-12 expected May 1, 2027. The company ended the quarter with $314 million in cash and a $13 million net loss, and said it was cash-flow positive excluding stock-based compensation and other one-time items.

Axsome Therapeutics NASDAQ: AXSM reported $260 million in third-quarter revenue, driven by growth in its AUVELITY treatment for major depressive disorder and Alzheimer’s disease agitation, executives said at the Guggenheim Healthcare Innovation Conference.

Chief Financial Officer Nick Pizzie said quarterly revenue exceeded a $1 billion annualized run rate for the first time. AUVELITY generated $208 million, up 53% from a year earlier and 15% from the second quarter.

Chief Operating Officer Mark Jacobson said Axsome has three commercial products across four indications, alongside a pipeline of 10 programs. The company expects 2027 to bring potential development milestones, including a regulatory decision on AXS-12 for cataplexy in narcolepsy.

AUVELITY Prescription Growth

Pizzie said new-to-brand prescriptions are a leading indicator of future AUVELITY growth. Among patients aged 65 and older, monthly new-to-brand prescriptions rose from approximately 1,000 before the Alzheimer’s agitation approval to 3,600 by the end of September.

Across all AUVELITY prescriptions, new-to-brand prescriptions averaged 2,400 per week in the first quarter, 3,000 in the second quarter and 3,550 in the third quarter. Pizzie said the product was tracking at 3,800 per week in October.

He said it typically takes a couple of quarters for new prescriptions and subsequent refills to be reflected more fully in total prescription volumes. Axsome expects continued growth in the underlying depression business and accelerated growth in Alzheimer’s agitation, although it has not provided specific quarterly sales guidance.

Axsome expanded its sales force from approximately 270 representatives to around 650 over roughly six months, Pizzie said. Jacobson added that a dedicated team is working in long-term care, where prescribing can take longer to develop because facilities require education and systems activation.

On pricing, Pizzie said the gross-to-net adjustment improved to the mid-to-high 40% range in the third quarter. He said it could rise in the fourth quarter and suggested using the corresponding 2026 quarters as a starting point for 2027 estimates, while noting that changes in Medicare mix or coverage arrangements could affect the outcome.

Pipeline and Financial Position

SUNOSI, Axsome’s treatment for excessive daytime sleepiness, generated approximately $46 million in quarterly revenue, Pizzie said. SYMBRAVO, for acute migraine treatment, generated $3.9 million. The company also recognized an approximately $8.5 million milestone during the quarter.

Axsome is awaiting first-quarter 2027 results from a SUNOSI study in binge eating disorder. Jacobson said a statistically significant result on the primary endpoint would constitute a positive study, but the company would still need a second trial before pursuing an application for that indication.

Other SUNOSI development work includes studies in depression with excessive daytime sleepiness, attention-deficit/hyperactivity disorder and shift work disorder. Jacobson said the depression study is event-driven, making its readout timing uncertain, while enrollment is expected to be completed in 2027.

The FDA decision date for AXS-12 is May 1, 2027. Jacobson said the review was proceeding as expected and that pre-launch activities were underway. Axsome could use its existing sleep-disorder sales infrastructure if the product is approved, executives said.

Axsome ended the quarter with $314 million in cash and reported a $13 million net loss. Pizzie said the company was cash-flow positive for the first time in the quarter on a basis that excluded stock-based compensation and other one-time items, but cautioned that Axsome had not projected sustained cash-flow positivity. The company’s priority remains growing revenue across its three brands, he said.

About Axsome Therapeutics (NASDAQ:AXSM)

Axsome Therapeutics is a biopharmaceutical company focused on developing and commercializing treatments for central nervous system disorders. The company is headquartered in New York and is led by founder, chairman and chief executive officer Herriot Tabuteau.

Its marketed products include Auvelity, an oral treatment for major depressive disorder in adults, and Sunosi, which is used to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

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