Axsome Therapeutics Inc (AXSM) Q1 2026 Earnings Call Transcript
Axsome Therapeutics, Inc., a biopharmaceutical company, develops and delivers novel therapies for the management of central nervous system (CNS) disorders in the United States. The company's commercial product portfolio includes Auvelity (dextromethorphan-bupropion), a N-methyl-D-aspartate receptor antagonist, sigma-1 receptor agonist, aminoketone, and CYP2D6 inhibitor indicated for the treatment of major depressive disorder in adults; Sunosi (solriamfetol), a dopamine and norepinephrine reuptake inhibitor, trace amine-associated receptor 1 agonist, and 5-HT1A agonist indicated for the treatment of excessive daytime sleepiness in patients with narcolepsy or obstructive sleep apnea; and Symbravo (MoSEIC meloxicam rizatriptan), or AXS-07, a rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor, and 5-HT1B/1D agonist indicated for the acute treatment of migraine with or without aura. It also develops AXS-05 (dextromethorphan-bupropion), an investigational N-methyl-D-aspartate receptor antagonist, which has completed Phase III clinical trial to treat Alzheimer's disease agitation, as well as that has completed phase II clinical trial for the treatment of smoking cessation; AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, which has completed Phase III trial to treat narcolepsy; AXS-14 (esreboxetine), a selective and potent norepinephrine reuptake inhibitor that has completed Phase III trial for the treatment of fibromyalgia and other conditions; and Solriamfetol, a dopamine and norepinephrine reuptake inhibitor, which is in Phase III trial for treating attention deficit hyperactivity, major depressive, binge eating, and excessive sleepiness associated with shift work disorder. It has a research collaboration agreement with Duke University for evaluating AXS-05 in a Phase 2 clinical trial in smoking cessation. The company was incorporated in 2012 and is based in New York, New York.
Axsome delivered solid top-line growth, advancing a broad CNS pipeline while preparing for ADA approval and a major sales force expansion to sustain momentum.
⭐ Key Highlights
✔Positive Signals
- Auvelity surpassed $500M in annual sales in 3rd full year
- ADA sNDA accepted with priority review and PDUFA date of April 30
- Q4 and full-year revenue growth of 65-66% YoY
- Major expansion of Auvelity sales force to ~600 reps planned for 2026
- Acquisition of AZD7325 (AXS-17) to broaden late-stage CNS pipeline
✖Negative Signals
- Gross-to-net discounts rising (Auvelity/Sunosi mid-40s to mid-50s range; Cymbravo high-70s during launch)
- Net loss for 2025 of $183.2M despite revenue growth
- High SG&A spend driven by commercial launches and DTC campaign
- R&D spend remained elevated with ongoing Phase III/late-stage programs
- Dependence on successful ADA approval and timely launches for upside
📊Financial Results
- Total product revenue: Q4 $196M, full-year $638.5M, up 65% and 66% YoY respectively
- Auvelity net product sales: Q4 $155.1M, full-year $507.1M, up 68% QoQ; 2025 gross-to-net high-40% range, expected mid-50% in 2026
- Sunosi net product revenue: Q4 $36.7M, full-year $124.8M, up 40% YoY; full-year growth driven by volume and persistence
- SG&A: Q4 $160.3M, full-year $570.6M, up 39% YoY due to commercialization efforts
- Net loss: Q4 $28.6M; full-year net loss $183.2M (vs. prior-year loss $287.2M); 2025 includes $93.8M stock-based compensation
🔮Future Guidance
- Cash balance of $323M as of year-end 2025 expected to fund operations into cash flow positivity under current plan
- Auvelity and Sunosi GTN expected to rise to mid-50% and Cymbravo GTN likely to remain elevated during launch; coverage expansion anticipated through 2026
- Sales force expansion to ~600 for Auvelity aimed at accelerating MDD and ADA readiness; operating leverage expected to continue in 2026
- ADA label expansion and potential uptake in Medicare Part D channel anticipated to influence GTN and access dynamics
💡Interesting Insights
- DTC national TV campaign for Auvelity generated inflection in new patient starts, with optimization planned for 2026
Detailed Analysis
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