Axsome Therapeutics, Inc. Q1 FY2026 earnings call

1. Focus is on revenue growth first, then cash flow positivity, then profitability. 2. SG&A increased this quarter for reasons like Q1 phasing, marketing spend for ADA approval, faster field force expansion, and DTC spend for Valid in MDD. Anticipate SG&A to increase in Q2 but at a slower rate, with operating leverage expected as top-line revenue growth outpaces operating expenses. 3. Excited about AXS-12's Phase III clinical trial results for narcolepsy, showing significant reduction in weekly cataplexy attacks early on, safe and tolerable, with benefits across secondary endpoints. 4. Team engaged with payers and LTC organizations for patient access, and will call on ~68,000 HCPs with expanded sales team, half being high volume treaters of both Alzheimer's disease agitation and major depressive disorder. 5. Primary focus on executing launch in ADA and successful commercialization in U.S. while identifying ideal partner for OUS with OVALITY.

1. Haven't guided specifically on sales ramp over the course of the year, but Q1 has market seasonality which is transitory as seen in early demand trends in Q2. 2. Update to peak sales estimate for AB and OILT guided by internal analysis and final label for agitation, expecting increasing frontline use in both indications. 3. IRA negotiations won't impact availability until 2031 assuming it meets Part D product requirements, and $8 billion shared contemplates any IRA impact.

Q: Regarding quarterly sequencing and IRA implications for Ovelity.

A: Haven't guided on sales ramp specifically, Q1 has transitory seasonality with early demand trends in Q2; IRA negotiations won't impact availability until 2031 assuming meeting Part D requirements and $8 billion shared contemplates IRA impact.

Q: How to think about positioning Synosy ahead of Rex and Agonist launch and SG&A ramp in 2026.

A: SG&A increased this quarter for reasons including Q1 phasing, marketing spend for ADA approval, faster field force expansion, and DTC spend for Valid in MDD; anticipate SG&A to increase in Q2 at a slower rate than Q4 to Q1, with operating leverage expected.

Q: About availability in LTC and number of prescribers for AD agitation and depression.

A: Difficult to predict LTC bolus exactly but team engaged with payers; will call on ~68,000 HCPs with half being high volume treaters of both indications.

Q: Follow-up on long-term guidance of AB and OILT sales uptake and OUS development plan for OVALITY.

A: Uptake in next two to three years to be learned as sales force is in market, Alzheimer's agitation is new launch with expected growth in MDD continuing and more to share on Alzheimer's agitation launch; primary focus on executing ADA launch and U.S. commercialization while identifying ideal OUS partner for OVALITY