Axsome Therapeutics, Inc. Q2 FY2025 earnings call

• Axsome delivered strong second quarter with $150 million in total revenue, driven by Auvelity and Sunosi growth. - SYMBRAVO launched on June 10, marking a significant milestone. - Advanced late-stage neuroscience pipeline, including AXS-05 on track to submit sNDA for Alzheimer's disease agitation, AXS-12 on track for NDA submission in Q4, AXS-14 to initiate Phase III trial in Q4, and solriamfetol programs advancing across indications. - Hosted Frontiers in Brain Health R&D Day showcasing pipeline breadth and depth.

Total product revenues for the second quarter were $150 million. Auvelity had net product sales of $119.6 million, up 84% year-over-year and 24% quarter-over-quarter. Sunosi net product revenues were $30 million, up 35% year-over-year and 19% quarter-over-quarter, with $28.9 million in net product sales and $1.1 million in royalty revenue from out-licensed territories. SYMBRAVO, launched on June 10, generated net sales of $410,000 in the partial quarter. Auvelity and Sunosi gross to net discounts were in the mid-50s range for the quarter, while SYMBRAVO's gross net was in the low 80% range.

• Plan to submit sNDA for AXS-05 in Alzheimer's disease agitation this quarter. - Expect to initiate Phase II/III trial for AXS-05 in smoking cessation in Q4. - NDA submission for AXS-12 slated for Q4. - Initiate Phase III trial for AXS-14 in Q4 to address FDA feedback. - Solriamfetol development programs continue advancing across indications with Phase III trial in pediatric ADHD expected to initiate in Q4.

• Forward-looking statements are based on current information, assumptions, and expectations subject to change. - Actual results may differ materially from forward-looking statements due to risks and uncertainties described in SEC filings.

Q: Leonid Timashev asked about payer coverage expansion for Auvelity and volume pull forward in the second half.

A: Ari Maizel said it's pull-through of previously announced GPO contracts, and Nick Pizzie mentioned Auvelity GTN remains in mid-50s range.

Q: Sean Laaman asked about AXS-12 market positioning against oxybate and NDA filing data.

A: Ari Maizel discussed AXS-12's potential profile in narcolepsy and the NDA package will include 3 controlled trials.

Q: Ami Fadia's representative asked about SYMBRAVO sampling program and access barriers.

A: Ari Maizel talked about sampling and patient savings program utilization, and coverage expansion.

Q: Jason Gerberry asked about SYMBRAVO revenue recognition.

A: Nick Pizzie and Ari Maizel discussed short quarter revenue recognition, script dynamics, and coverage impact.

Q: Steve Stavropoulos asked about AXS-05 adoption in Alzheimer's agitation.

A: Herriot Tabuteau discussed mechanistic distinction and commercial strategy.

Q: Ash Verma asked about Auvelity net sales growth and GTN.

A: Nick Pizzie explained GTN stability, inventory, and liability change.

Q: Ram Selvaraju asked about SYMBRAVO gross to nets, coverage, and differentiators.

A: Nick Pizzie and Ari Maizel discussed GTN trends, coverage expansion, and multi-mechanistic differentiator.

Q: Marc Goodman asked about precision medicine approach to ADHD.

A: Herriot Tabuteau explained precision medicine in MDD and ADHD strategy.

Q: David Amsellem asked about Auvelity sales force and frontline usage.

A: Ari Maizel discussed sales force impact and early line usage.

Q: Cerena Chen asked about AXS-05 FDA data package.

A: Unidentified representative said sNDA submission on track.

Q: Andrew Tsai's representative asked about AXS-05 commercial strategy and AdCom talking points.

A: Ari Maizel and unidentified representative discussed commercial strategy and potential AdCom points.

Q: Asim Rana asked about AXS-05 smoking cessation study and sales split.

A: Herriot Tabuteau discussed study design and sales split by product.

Q: Yatin Suneja asked about Auvelity MDD inflection and duration.

A: Ari Maizel discussed sales force impact, DTC plans, and duration of prescriptions.

Q: Joseph Thome asked about pediatric ADHD trial.

A: Herriot Tabuteau discussed trial design and confidence in pediatric data.

Q: Matthew Hershenhorn asked about AXS-12 and Sunosi commercial leverage.

A: Ari Maizel discussed leveraging Sunosi team for AXS-12 launch.

Q: Graig Suvannavejh asked about summer seasonality and Auvelity IRA pricing.

A: Ari Maizel discussed seasonality and Nick Pizzie talked about Auvelity IRA pricing timeline.

Q: Sam on behalf of David Hoang asked about Sunosi patient mix and commercial labs.

A: Ari Maizel discussed Sunosi prescriber growth and commercial lives coverage.

Q: Myles Minter asked about Sunosi pediatric ADHD trial alignment.

A: Herriot Tabuteau discussed strategies for including pediatric and adolescent patients in trials