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Introduction & Market Context
Axsome Therapeutics Inc (NASDAQ:AXSM) presented its Q1 2025 corporate update on May 5, highlighting strong commercial execution and pipeline advancement across its central nervous system (CNS) portfolio. The company, which focuses on developing treatments for conditions with significant unmet needs, reported substantial revenue growth and continued progress on multiple late-stage clinical programs.
The presentation emphasized Axsome’s strategic positioning across 10 CNS conditions affecting more than 150 million people in the United States, including major depressive disorder, Alzheimer’s disease agitation, ADHD, and migraine. This broad therapeutic approach underpins the company’s ambitious growth strategy.
As shown in the following slide detailing Axsome’s therapeutic focus areas, the company has identified critical gaps in care across multiple CNS conditions:
Quarterly Performance Highlights
Axsome reported total net product revenue of $121.5 million for Q1 2025, representing a 62% year-over-year increase compared to Q1 2024. This growth was primarily driven by strong performance from AUVELITY for major depressive disorder and steady contributions from SUNOSI for excessive daytime sleepiness.
The company also highlighted several key pipeline achievements, including the FDA approval of SYMBRAVO for acute migraine in January 2025, with commercial launch planned for June 2025. Additionally, Axsome submitted a New Drug Application (NDA) for AXS-14 in fibromyalgia and announced positive topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD and the EMERGE Phase 3 trial of SYMBRAVO.
The following slide summarizes Axsome’s Q1 2025 highlights across commercial execution, pipeline advancement, and financial strength:
Commercial Portfolio Performance
Axsome’s commercial portfolio continues to show strong momentum, with its lead product AUVELITY achieving $96.2 million in net sales during Q1 2025, an 80% increase compared to the same period last year. The company reported that approximately 190,000 new patients have started AUVELITY since launch, with more than 36,000 unique prescribers. Notably, about 50% of prescriptions come from first or second line usage, indicating strong market adoption.
As illustrated in the following chart, AUVELITY has demonstrated consistent quarter-over-quarter growth since its launch:
SUNOSI, Axsome’s treatment for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, generated $25.2 million in net revenue during Q1 2025, representing a 17% year-over-year increase. The company noted that approximately 85,000 new patients have started SUNOSI since its initial launch, with more than 14,000 unique prescribers.
The following chart shows SUNOSI’s quarterly revenue performance:
Axsome’s third commercial product, SYMBRAVO for acute migraine, received FDA approval in January 2025 and is scheduled for commercial launch in June 2025. The company is positioning SYMBRAVO to address significant unmet needs in the migraine market, where more than 80% of patients discontinue their acute treatment within the first 12 months due to limited efficacy or side effects.
The following slide highlights Axsome’s leading commercial portfolio in CNS:
Pipeline Development Progress
Axsome continues to advance its robust pipeline, with multiple late-stage clinical programs targeting high-value CNS indications. The company’s development strategy leverages its expertise in CNS disorders and innovative approaches to drug development.
The following slide provides a comprehensive overview of Axsome’s neuroscience pipeline across psychiatry and neurology:
A key pipeline candidate is AXS-05 for Alzheimer’s disease agitation, which demonstrated statistically significant and clinically meaningful improvements in the ADVANCE-1 and ACCORD-2 clinical trials. The company plans to submit a supplemental New Drug Application (sNDA) for this indication in Q3 2025.
The following slide shows the efficacy results from the AXS-05 clinical trials in Alzheimer’s disease agitation:
Solriamfetol, already marketed as SUNOSI for excessive daytime sleepiness, is being developed for multiple additional indications including ADHD, major depressive disorder with excessive daytime sleepiness, binge eating disorder, and shift work disorder. The FOCUS Phase 3 trial in ADHD demonstrated substantial improvements in ADHD symptoms, with effects observed as early as week 1.
The following slide details the ongoing Phase 3 development programs for solriamfetol:
Financial Position and Outlook
As of March 31, 2025, Axsome reported $300.9 million in cash and cash equivalents, which the company expects will fund operations into cash flow positivity. The company’s debt (face value) stood at $180 million, with a market capitalization of approximately $5.5 billion as of May 2, 2025.
Axsome projects significant long-term revenue potential across its commercial and late-stage assets, with an estimated peak sales potential of $16.5 billion. This includes $1-3 billion for AUVELITY, $300-500 million for SUNOSI, and $500 million to $1 billion for SYMBRAVO.
The following slide illustrates the peak sales potential across Axsome’s portfolio:
Looking ahead, Axsome has outlined several key catalysts for 2025 and 2026, including the commercial launch of SYMBRAVO in June 2025, FDA filing acceptance decision for AXS-14 in fibromyalgia expected in Q2 2025, sNDA submission for AXS-05 in Alzheimer’s disease agitation in Q3 2025, and NDA submission for AXS-12 in narcolepsy in the second half of 2025.
With its growing commercial portfolio and advancing pipeline, Axsome appears well-positioned to continue its growth trajectory in the CNS market, though investors should monitor the company’s progress toward profitability as operating expenses continue to increase alongside revenue growth.
Full presentation:
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