Key Takeaways:
Axsome Therapeutics Inc. (NASDAQ: AXSM) reported a 57 percent year-over-year revenue increase to $191.2 million for the first quarter of 2026, though its net loss widened amid higher spending to support its commercial products and upcoming drug launches.
"The FDA approval of Auvelity for Alzheimer’s agitation marks a significant milestone, reflecting our commitment to addressing unmet medical needs with innovative therapies," Chief Executive Officer Herriot Tabuteau said in a statement.
The biopharmaceutical company posted a quarterly loss of $1.26 per share, missing analyst estimates of a $0.83 loss, while revenue came in slightly below forecasts of $193.46 million. Despite the mixed results, the company’s stock rose in pre-market trading, fueled by positive strategic developments.
The core of investor optimism stems from Auvelity, which drove revenue with $153.2 million in net sales, a 59 percent increase from the year-ago quarter. Last week, the U.S. Food and Drug Administration approved Auvelity for the treatment of agitation associated with Alzheimer’s disease, a major new market for the drug which is also approved for major depressive disorder.
Following the approval, Axsome raised its peak annual sales forecast for Auvelity to at least $8 billion, with contributions split between its two approved indications. To support a planned June launch for the new indication, the company has expanded its sales force to approximately 630 representatives and secured payer coverage for 86% of lives across all channels.
Axsome’s total revenue was also bolstered by its other commercial products. Sunosi, a treatment for excessive daytime sleepiness, generated $33.9 million, up 34% year-over-year. Symbravo, for migraine, recorded $4.1 million in sales. The company also advanced its pipeline, submitting a New Drug Application (NDA) for AXS-12 for the treatment of narcolepsy.
The growth came at a cost, as selling, general and administrative (SG&A) expenses rose to $185 million from $120.8 million a year ago. The increase was driven by pre-launch activities for Auvelity’s new indication and a national direct-to-consumer advertising campaign. Research and development expenses also increased to $52.7 million. The company ended the quarter with $305 million in cash, which management stated is sufficient to fund operations to cash flow positivity.
The updated guidance for Auvelity signals management's high confidence in its commercial execution and the drug's market potential in two large, underserved patient populations. Investors will watch the commercial launch in Alzheimer's agitation in June and subsequent quarterly reports to track the sales ramp and progress toward profitability.
This article is for informational purposes only and does not constitute investment advice.
