Axsome Therapeutics (AXSM) investor relations material

Commercial performance and product updates

• Q3 net sales reached $171M, with a leading product in MDD generating $136M, up 69% YoY and 14% QoQ.

• Direct-to-consumer (DTC) campaign launched nationally, already driving record weekly new prescriptions and expected to impact refills into 2026.

• Sunosi achieved 35% YoY growth with a lean team, and Cymbravo, launched for migraine, reported $2.1M in its first full quarter.

• Early DTC results show increased Google searches and new prescription highs, with ROI anticipated from refills over the next two years.

• Sales force currently at 300 reps, with expansion planned upon ADA approval and launch, especially targeting long-term care centers.

Market access, pricing, and patient reach

• Achieved high 40s gross-to-net discount in Q3, with 85% total covered lives, including 100% in government and 75% in commercial channels.

• Recent GPO agreement provides a pathway for the remaining 25% of uncovered lives.

• Early line use for the lead product is now about 50%, with over half as monotherapy, and market access is supporting earlier utilization.

• DTC campaign is executed with disciplined spending, using test markets before national rollout.

Pipeline and regulatory progress

• NDA-stage programs include AXS-5 for AD agitation and AXS-12 for narcolepsy, with several Phase III programs ongoing or starting soon.

• For ADA, the regulatory package includes three positive, well-controlled trials and a robust safety database, aligning with FDA feedback.

• Breakthrough therapy designation maintained for ADA; standard review timeline modeled due to broader FDA resource considerations.

• Narcolepsy NDA filing is pending completion of submission modules; market is considered orphan with differentiated product profile.