Axsome Therapeutics (AXSM) investor relations material

Regulatory and clinical updates

• Awaiting FDA acceptance decision for Auvelity in Alzheimer's disease agitation, with expectation of standard review due to FDA resource constraints.

• Submission package includes three positive controlled trials and breakthrough therapy designation, with robust efficacy and safety data.

• FDA feedback and guidance support the use of different trial designs, including randomized withdrawal studies, for substantial evidence.

• Solriamfetol development ongoing in multiple indications: shift work disorder (top-line data next year), pediatric/adolescent ADHD (study starting this quarter), MDD with excessive daytime sleepiness, and binge eating disorder (top-line data next year).

• GABA-A alpha 2/3 positive allosteric modulator in preclinical phase, with phase 2 enabling work and indication selection underway.

Commercialization and market access

• Current sales force of 300 reps for MDD, with plans to expand upon ADA approval, including a discrete long-term care team.

• Peak sales opportunity estimated at $1.5–$3 billion for ADA and $1–$3 billion for MDD, with total potential of $2.5–$6 billion.

• 100% government channel and 75% commercial access for Auvelity, totaling 85% covered lives; majority of ADA scripts expected in government channel.

• Long-term care setting represents about 10–20% of ADA market, with majority in community dwelling.

• DTC campaign for MDD launched nationally, with plans for continued investment and potential future campaigns for ADA.

Product performance and strategy

• Auvelity NBRXs increased from 2,000 to 2,750–2,800 per week after sales force expansion and DTC campaign.

• Over 50% of Auvelity use is monotherapy; 15% first-line and 35% second-line usage, with growth expected.

• Gross-to-net for Auvelity improved from mid-50s% to high 40s% in Q3, with slight uptick expected in Q4/Q1; ADA approval could further improve GTN.

• Symbrava launch focused on headache centers, with 550–600 reps; positive clinician feedback on efficacy and tolerability.

• Symbrava access at 52% covered lives, GTN expected between Auvelity and gepants (70% range), with long-term access growth targeted.