Axsome Therapeutics, Inc. Q4 2025 Earnings Call Summary

Axsome Therapeutics, Inc. Q4 2025 Earnings Call Summary Moby Intelligence Tue, February 24, 2026 at 1:31 AM GMT+8 3 min read In this article:

AXSM -2.75%

Axsome Therapeutics, Inc. Q4 2025 Earnings Call Summary - Moby

Strategic Performance and Operational Drivers

• Achieved 66% annual revenue growth driven by Auvelity's rapid uptake, which surpassed $500,000,000 in net sales in its third full year of launch.

• Attributed Auvelity's outperformance to its distinct clinical profile and fast onset of action, allowing it to grow 42% year-over-year while the broader antidepressant market remained flat.

• Expanded the primary care prescriber base for Auvelity, which now represents approximately one-third of all prescribers and is the fastest-growing segment.

• Initiated a major sales force expansion to approximately 600 representatives to support continued MDD growth and prepare for the potential Alzheimer’s disease agitation (ADA) launch.

• Reported accelerating momentum for Sunosi with 40% fourth-quarter revenue growth, driven by increased depth among existing writers in both OSA and narcolepsy markets.

• Successfully contracted with a third large commercial GPO for Cymbravo, enabling negotiations with all major commercial payers and PBMs to improve market access.

• Acquired AXS-17, a novel GABA-A modulator, to leverage the company's CNS expertise and existing safety data for a new development program in epilepsy.

Outlook and Strategic Roadmap

• Anticipates a PDUFA action date of April 30 for Auvelity in Alzheimer’s disease agitation, with launch readiness activities currently underway.

• Expects to submit the NDA for AXS-12 in narcolepsy imminently following positive pre-NDA meeting minutes with the FDA.

• Plans to initiate two parallel Phase III trials for solriamfetol in pediatric and adolescent ADHD patients during the first half of 2026.

• Projects top-line results for solriamfetol in binge eating disorder in the second half of 2026, while shift work disorder results are now anticipated in 2027.

• Assumes Auvelity and Sunosi gross-to-net discounts will increase to the mid-50% range in early 2026 due to typical first-quarter dynamics.

Financial and Risk Factors

• Maintained a cash balance of $323,000,000, which management believes is sufficient to fund operations until the company reaches cash flow positivity.

• Reported that Cymbravo gross-to-net discounts remained in the high-70% range during the initial launch phase, with expectations for them to remain elevated in the near term.

• Noted that the 39% increase in annual SG&A expenses was primarily driven by the national DTC advertising campaign and sales force expansion.

• Flagged that while ADA coverage is expected to mirror MDD, the ADA market is more heavily weighted toward Medicare Part D, which may alter the net price profile.

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Q&A Session Highlights

Impact of FDA one-trial policy on pipeline strategy

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• Management noted that while the new FDA guidance is being assessed, clinical plans are already vetted with the agency on an indication-specific basis.

• Confirmed that for shift work disorder, the FDA has already aligned that the existing package could serve as supportive evidence if the current study is positive.

Commercial strategy for Alzheimer's disease agitation launch

• Management expects to be ready for a full-scale launch within one quarter of potential approval, utilizing the expanded 600-person sales force.

• Indicated that approximately 60% of the ADA market is community-based while 40% is in long-term care, and the sales force will target both segments.

Gross-to-net dynamics for Auvelity in the ADA indication

• Management anticipates that over 70% of ADA prescriptions will be in the Medicare Part D channel.

• Expected potential favorability in aggregate gross-to-net for Auvelity because the Medicare channel lacks the co-pay card utilization costs seen in the commercial channel.

Differentiation of AXS-12 versus emerging orexin agonists

• Management emphasized that narcolepsy often requires polypharmacy and that AXS-12 targets the norepinephrine pathway, which is downstream from orexin neurons.

• Highlighted AXS-12's specific benefits in cataplexy, cognition, and comorbid depression as key differentiators in a market where trial-and-error is common.

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