Axsome Therapeutics Q2 Earnings Call Highlights

Key Points

• Q2 revenue rose 46% year over year to $218 million, led by AUVELITY sales of $180.3 million, while the net loss widened to $51.3 million. Axsome ended the quarter with approximately $320 million in cash and expects its existing funds to support operations through cash-flow positivity.
• AUVELITY demand continued to accelerate, including a 126% increase in new-to-brand prescriptions among patients aged 65 and older during the first eight weeks of its Alzheimer’s disease agitation launch. Overall prescriptions rose 34% year over year, supported by expanded sales coverage and 89% access to covered lives.
• The FDA accepted Axsome’s AXS-12 application for cataplexy in narcolepsy, with a target decision date of May 1, 2027. The company also expects to initiate a Phase II/III smoking-cessation trial for AXS-05 and said its late-stage pipeline could support roughly one new drug application annually through 2030.

Axsome Therapeutics NASDAQ: AXSM reported second-quarter 2026 net product revenue of $218 million, up 46% from a year earlier, as sales of AUVELITY and SUNOSI increased and prescription demand for SYMBRAVO continued to build.

The company posted a net loss of $51.3 million, or $0.99 per share, compared with a net loss of $48 million, or $0.97 per share, in the second quarter of 2025. Axsome ended the quarter with approximately $320 million in cash and cash equivalents, versus $323 million at the end of 2025.

Chief Executive Officer Dr. Herriot Tabuteau said the quarter included commercial growth as well as regulatory and clinical progress across the company’s neuroscience pipeline. Axsome said it expects its existing cash balance to fund operations into cash-flow positivity.

AUVELITY Drives Revenue Growth

AUVELITY generated $180.3 million in quarterly net product sales, rising 51% year over year and 18% sequentially. SUNOSI contributed $35.8 million in revenue, including $33.8 million in net product sales, $1.5 million in royalty revenue from out-licensed territories and $500,000 in milestone revenue.

SYMBRAVO recorded net product sales of $2.3 million. While that was above the $400,000 reported in the prior-year quarter, it was down $1.8 million from the first quarter of 2026. Chief Financial Officer Nick Pizzie said the sequential decline primarily reflected a prior-period adjustment and greater use of the company’s patient-service program amid demand growth.

SYMBRAVO’s gross-to-net discount reached the high-80% range during the quarter, a deviation from trend that Axsome expects to normalize for the remainder of the year. Gross-to-net discounts for AUVELITY and SUNOSI were each approximately 50%, with the company expecting improvement through the year.

Cost of revenue was $13.6 million, or 6% of total net revenue. Research and development expense declined to $46.2 million from $49.5 million a year earlier, primarily due to lower costs associated with AXS-05 and AXS-14. Selling, general and administrative expense increased to $208.1 million from $130.3 million, driven mainly by commercialization activities for AUVELITY and SYMBRAVO.

AUVELITY Expansion and Alzheimer’s Agitation Launch

Axsome launched AUVELITY for Alzheimer’s disease agitation during the quarter and completed an expansion of its AUVELITY sales force. Chief Commercial Officer Ari Maizel said early launch measures pointed to accelerating demand.

During the first eight weeks after the Alzheimer’s disease agitation launch, new-to-brand prescriptions among patients age 65 and older rose 126% compared with the same period in the prior quarter. Maizel said feedback from both community and long-term-care settings had been encouraging, though management said it was too early to provide more detailed metrics by setting of care.

Overall AUVELITY new-to-brand prescriptions increased 26% from the first quarter, while total prescriptions reached roughly 266,000, up 34% year over year and 12% sequentially. Axsome said the broader antidepressant market grew 1% year over year and 2% sequentially over the same periods.

The expanded sales organization activated more than 6,800 new AUVELITY prescribers during the quarter, a 21% increase from the prior quarter, bringing total unique prescribers since launch to approximately 69,000. Maizel said primary care was the predominant source of growth during the quarter, with growth also occurring in psychiatric specialties.

AUVELITY coverage reached approximately 89% of total lives, including 82% of commercial lives and nearly all government-channel lives. The company said more than 75% of Alzheimer’s disease agitation patients do not require prior authorization, while acknowledging that requirements can vary by coverage plan.

Axsome is using free samples in community settings to allow patients and care partners to begin titration before filling a prescription. Maizel said samples are not prescriptions and are not reflected in IQVIA prescription data.

SYMBRAVO and SUNOSI Prescription Growth

SYMBRAVO total prescriptions increased 30% sequentially to approximately 23,500. Axsome said its expansion to about 150 sales representatives was substantially complete and would support greater engagement with headache specialists and continued penetration in primary care.

Payer coverage for SYMBRAVO was approximately 57% of lives across channels following the addition of about 17 million covered lives in the second quarter. The company expects coverage to improve further.

SUNOSI produced approximately 61,000 total prescriptions, up 14% from a year earlier and 8% from the prior quarter. Axsome said the wake-promoting agent market declined 1% year over year and grew 2% sequentially. More than 17,000 clinicians have prescribed SUNOSI since launch, and payer coverage was approximately 82% across channels.

Pipeline Advances Include AXS-12 NDA Review

The FDA accepted Axsome’s new drug application for AXS-12 for cataplexy in narcolepsy, setting a target action date of May 1, 2027. The company said AXS-12 has demonstrated onset of action at one week, durable efficacy data through six months, and potential effects on excessive daytime sleepiness and cognition, though it remains subject to FDA review.

Axsome also said it remains on track to begin a Phase II/III trial of AXS-05 for smoking cessation during the current quarter. Its solriamfetol development program includes five ongoing Phase III trials across attention-deficit/hyperactivity disorder, binge eating disorder, major depressive disorder with excessive daytime sleepiness symptoms, and excessive daytime sleepiness associated with shift work disorder.

• Top-line results from the ENGAGE Phase III trial of solriamfetol in binge eating disorder are expected in the fourth quarter of 2026.
• Axsome recently initiated the FOCUS-2 and FOCUS-3 pediatric ADHD trials of solriamfetol.
• Enrollment continues in the FORWARD Phase III trial of AXS-14 for fibromyalgia.
• The company is advancing manufacturing work for AXS-20, or balipodect, ahead of a planned Phase III schizophrenia trial.
• Phase II-enabling work is also underway for AXS-17 in epilepsy.

Tabuteau said the company’s late-stage pipeline could support, on average, one new NDA filing annually through 2030.

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.

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