Axsome Therapeutics (AXSM) Morgan Stanley 24th Annual Global Healthcare Conference summary

R&D and innovation trends

• China-originated innovation is increasing, with more early-stage products and third-party R&D vendors emerging as viable options, but overall R&D approach remains steady.

• AI is integrated across commercial operations, sales analytics, document drafting, and CMC monitoring, driving efficiency and productivity.

• AI supports sales reps but does not replace face-to-face interactions with healthcare professionals.

Regulatory and policy environment

• IRA negotiations are the most significant policy factor, with potential impact starting in 2032; preparations include HEOR analysis and conservative peak sales modeling.

• FDA interactions are stable, with three approved products and ongoing dialogue for additional marketing applications; AXS-12 is under review with a PDUFA date of May 1.

AUVELITY launch and performance

• Q2 growth was driven mainly by MDD, with Q3 showing increasing impact from the Alzheimer's agitation indication.

• NBRXs reached a new high, with the 65+ Medicare cohort growing from 19% to 31% of NBRXs post-approval.

• Growth is in line with expectations, with new prescribers and positive real-world feedback supporting future utilization.

• Plans are in place to provide more detailed launch metrics in upcoming quarters.