Axsome Therapeutics (AXSM -0.05%), a biopharmaceutical company focused on central nervous system (CNS) disorders, released its earnings on August 4, 2025. The company reported GAAP revenue of $150.0 million, up 72% compared to the prior year period, and a net loss per share of $(0.97) (GAAP), which beat consensus GAAP revenue estimates (estimated at $138.25 million) and EPS (GAAP, estimated at $(1.05)). Double-digit prescription gains for its commercial drugs, major coverage wins, and the early launch of a new migraine therapy were the most significant highlights. Despite substantial progress, the company remains unprofitable, posting a GAAP net loss of $48.0 million. Overall, the quarter featured strong top-line momentum and notable execution on its commercial and research initiatives.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.97) | $(1.05) | $(1.67) | 41.9% |
| Revenue | $150.0 million | N/A | $87.2 million | 72.0% |
| Net Product Sales – AUVELITY | $119.6 million | $65.0 million | 84.0% | |
| Net Product Sales – SUNOSI | N/A | N/A | N/A | |
| R&D Expense | $49.5 million | $49.9 million | (0.8%) |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Strategic Focus
Axsome Therapeutics is dedicated to developing and commercializing medicines for conditions affecting the brain and nervous system. Its primary focus is on diseases with limited existing treatment options, such as depression, sleep disorders, migraine, narcolepsy, and other CNS-related conditions. The firm differentiates itself by using novel or repurposed compounds to address these unmet medical needs.
Recent efforts have centered on expanding access, increasing prescriptions, and launching new therapies. Key to its success are rapid payer coverage gains for its lead treatments, the ongoing development of late-stage candidates, and protection of its intellectual property through patents and strategic legal settlements.
Second Quarter Highlights and Performance Review
Revenue climbed 72% compared to the prior year period, beating analyst consensus by over $11 million in GAAP revenue. This surge was driven by strong performance from its flagship antidepressant AUVELITY and the sleep disorder drug SUNOSI, with both products surpassing previous sales and prescription marks.
AUVELITY, an oral therapy for major depressive disorder, posted $119.6 million in net sales, 84% above the previous year. Prescriptions rose to about 192,000, a 56% increase compared to Q2 2024 and up 15% sequentially. The company secured expanded insurance coverage for AUVELITY, reaching approximately 83% of U.S. insured lives.
SUNOSI, a therapy for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, achieved $30.0 million in GAAP net product revenue, up 35% year over year. Prescriptions neared 50,000, reflecting 13% growth over the same period in 2024. A notable legal settlement during the quarter extends SUNOSI’s market exclusivity to 2040, supporting future revenue stability.
SYMBRAVO, a newly launched oral therapy for migraine, generated $0.4 million in net product sales after its debut on June 10, 2025. At launch, SYMBRAVO had payer coverage for about 38% of insured U.S. lives. Early access negotiations and group purchasing contracts have begun to lay groundwork for future growth in this segment, which will be critical in upcoming quarters.
Research and development (R&D) expenses were relatively stable at $49.5 million, down slightly from the year-ago period as some pivotal trials concluded. However, selling, general, and administrative (SG&A) costs rose to $130.3 million, up 26% compared to the same period in 2024. This increase in SG&A reflects commercialization investments for AUVELITY and SYMBRAVO, including sales force expansion and marketing preparedness, with further increases expected as direct-to-consumer campaigns roll out later in the year.
Net loss (GAAP) improved to $48.0 million from $79.3 million for Q2 2024. Management stated that current cash resources, totaling $303.0 million at June 30, 2025, are sufficient to reach cash flow positivity under the current operating plan. There were no dividend payments declared or announced. AXSM does not currently pay a dividend.
Pipeline Progress, Product Families, and Commercial Developments
Beyond its commercial products, Axsome has a diverse late-stage pipeline targeting multiple CNS disorders. The AUVELITY/AXS-05 franchise is being developed for Alzheimer’s disease agitation and smoking cessation, with a supplemental new drug application on track for Q3 2025 and a potential launch in 2026 if approved. This product family is already approved for major depressive disorder and is a key revenue driver.
AXS-12, targeting narcolepsy with cataplexy (sudden muscle weakness), saw its new drug application (NDA) timeline set for Q4 2025. Early data indicate meaningful reductions in cataplexy episodes and improvements in daytime alertness. Planned Phase 3 trials in pediatric attention deficit hyperactivity disorder and depression with excessive daytime sleepiness are scheduled for late 2025. The solriamfetol molecule, already marketed as SUNOSI for sleepiness, is being studied across additional indications—including binge eating disorder and shift work disorder—with major Phase 3 results expected in 2026. For fibromyalgia, a prevalent pain disorder, a new Phase 3 study of AXS-14 is set to launch in Q4 2025.
The commercial achievements this quarter were underpinned by strategic expansion of payer coverage and positive movement on market exclusivity. For example, National DTC advertising for AUVELITY is planned to launch later this year, and payor contracts are being pursued for broader access to SYMBRAVO. The company’s ability to secure exclusivity agreements—such as its patent litigation settlement for SUNOSI—protects it from generic competition in the coming years.
However, spending remains elevated as Axsome continues to invest in both commercial and scientific infrastructure. With a growing suite of assets, driving operational leverage will be important to delivering improved margins as the portfolio matures.
Looking Ahead: Guidance and Key Watch Items
Management reiterated its confidence in reaching cash-flow positivity using existing cash reserves but did not provide explicit guidance on when profitability may be achieved. No formal revenue or earnings targets were communicated for upcoming quarters or for fiscal 2025. Instead, management pointed to planned pipeline catalysts—such as regulatory filings and Phase 3 trial readouts—as the main milestones to watch in the coming year.
Going forward, investors should watch for expanding insurance coverage for SYMBRAVO, updates on the progress of late-stage pipeline programs, and signals on cost containment or commercialization efficiency. The continued scaling of AUVELITY and SUNOSI, successful new product launches, and progress on regulatory milestones will be critical. Future periods will also reflect the ramp-up of marketing and access initiatives and the impact of investment in new indications and product launches.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
