Axsome Therapeutics (AXSM) investor relations material

Business overview and strategic direction

• Focused on central nervous system disorders, aiming to deliver transformative medicines for CNS conditions affecting hundreds of millions globally.

• Three commercial products (Auvelity, Sunosi, SYMBRAVO) and five novel product candidates, with seven late-stage clinical trials underway or starting soon.

• Targeting 11 different conditions, with nine programs having blockbuster potential and total peak sales opportunity exceeding $16 billion.

• Patent protection for key assets extends into the 2040s, supporting long-term growth.

• Team expansion from 300 to 600 reps underway to support commercial and clinical growth.

2025 performance and financial highlights

• 2025 sales reached nearly $640 million, with Auvelity surpassing $500 million in its third year post-launch.

• Achieved quarters of cash flow positivity, with $323 million on the balance sheet and $190 million in debt after refinancing.

• Revenue grew three times faster than operating expenses in 2025, with continued operating leverage expected in 2026.

• Sunosi grew 40% year-over-year, and SYMBRAVO launched in June 2025, showing early growth.

Product and pipeline updates

• Auvelity is approved for major depressive disorder, with over 50% of scripts now first or second line, and strong growth in primary care.

• Sunosi, acquired in 2022, is performing well in narcolepsy and sleep apnea, with development for four additional indications underway.

• SYMBRAVO, launched in 2025 for acute migraine, is gaining traction with a small field force and positive clinician feedback.

• AXS-05 sNDA for Alzheimer's disease agitation has a PDUFA date of April 30, 2026, with robust clinical data and priority review.

• Multiple late-stage trials ongoing or planned for solriamfetol (Sunosi) in ADHD, MDD with excessive daytime sleepiness, binge eating disorder, and shift work disorder.

• NDA submission for AXS-12 in cataplexy and narcolepsy is imminent, with Orphan Drug Designation.

• AXS-14 in fibromyalgia is in a new phase III trial following FDA feedback; AXS-17 in-licensed for epilepsy, with phase II enabling work in 2026.