Axsome Therapeutics (AXSM) Q1 FY26 earnings call: guidance and Q&A

How will Axsome extract value from the LTC market for AUVELITY ADA, given 40% of patients reside there but current prescriber mix is PCP-heavy?

Axsome's expanded sales team of ~630 representatives will call on both community and LTC facilities. This is a concentrated market allowing for efficient promotion, and both settings are important for market penetration. The company expects LTC engagement to grow over time.

“Our sales team of approximately 630 representatives, we'll call them both community and long-term care facilities. And so for us, it's important to be present and to educate prescribers and care partners within both facilities or both settings of care.”

asked by Ashwani Verma · answered by Ari Maizel

Why was the AUVELITY peak sales outlook raised to $8 billion, and what assumptions led to $4 billion for each indication?

The FDA approval for ADA provides greater certainty for long-term sales. Market research on HCP perceptions, the clear final label, growing MDD penetration, and the expanded sales force support confidence in AUVELITY's potential as a frontline treatment in both large markets (7M ADA patients, 76% with agitation).

“when we review our proprietary market research on HCP perceptions, potential use of the product, taken together with the clarity around the final label, it really provides confidence that AUVELITY will be used as a frontline treatment in Alzheimer's agitation and we've seen growing uses frontline treatment and MDD.”

asked by Marc Goodman · answered by Ari Maizel

Can you discuss AXS-20's efficacy and safety profile, why it didn't hit statistical significance in Phase II, and the potential for a different outcome in Phase III, including data timing?

The Phase II schizophrenia trial showed clear separation and a high magnitude of treatment effect, with statistical significance on global measures, despite not being powered for it. Discontinuation rates due to lack of efficacy were much lower for balipodect. The safety profile is distinct from existing antipsychotics, showing no changes in glucose or prolactin levels, suggesting a major metabolic benefit. Phase III enabling activities are ongoing, targeting trial initiation around year-end.

“when we looked at the data there was clear separation, the magnitude of treatment effect, for balipodect was on the high end when you look at historical treatments for schizophrenia. Now because of the size of the study, obviously, it was not powered for statistical significance. But despite that, there was a very clear trend, and there was statistical significance on various measures, including, for example, global measures.”

asked by Lin Tsai · answered by Herriot Tabuteau

Given AUVELITY's long IP runway and commercial success, will Axsome pursue multiple other indications or a more sequential approach to maximize value ahead of IRA impact?

Axsome is in a favorable position with a long exclusivity runway and commercialized product, not resource-constrained for new indications. AUVELITY's unique pharmacology is applicable to many CNS conditions. The team has clear ideas for additional indications and aims to move quickly if an opportunity is worthwhile. Investors should 'stay tuned' for updates on further potential indications.

“We're in a very favorable position given that there is a very long exclusivity runway for AUVELITY and also the fact that the product is commercialized, we are not resource constrained as it relates to potentially developing for other indications. The other interesting thing about the product, which Mark touched upon is that it's unique pharmacology which is applicable to a number of potential CNS indications.”

asked by Ami Fadia · answered by Herriot Tabuteau

Are there signs of decreased antipsychotic use in nursing homes following the March OIG report on inappropriate use, and how does this impact the AUVELITY ADA launch?

There hasn't been an immediate substantial drop in antipsychotic use, as the news is relatively new. However, awareness of the OIG report and sensitivity regarding antipsychotic use in this patient population is very high among providers and family members. This provides a good foundation for the AUVELITY ADA launch, with an expectation of continued focus on antipsychotic use moving forward.

“But what I will say is that the awareness of that report and the sensitivity on using antipsychotics with this patient population is very high among providers and family members. So we think that provides a good foundation for the AUVELITY launch in the Alzheimer's disease agitation space, and expect there to be continued focus on antipsychotic use moving forward.”

asked by Jason Gerberry · answered by Ari Maizel

How should investors model the AUVELITY ADA launch ramp, considering the MDD launch experience, and when might Axsome provide specific guidance for ADA?

Predicting launch ramps is challenging. While AUVELITY MDD is an analog, ADA is a different market with greater awareness, better market access, and a larger sales team. Rexulti provides some insight into uptake in these settings. The company will learn more post-launch and share observations. Specific guidance is not being provided yet due to many variables, but peak sales guidance of $8 billion for AUVELITY has been given.

“it's hard to share specifics on what we expect the uptake to be, but we have seen strong growth in new patient starts and new rider activation, within NDV, which we expect to continue, and there will be another increase relative to the Alzheimer's agitation market, which share some common targets with MDD, but there are some distinct targets that we're adding to the call plan for this year.”

asked by Yatin Suneja · answered by Ari Maizel

Why was a randomized withdrawal design chosen for the CLARITY solriamfetol study in MDD, and would a positive result necessitate a parallel study?

Two positive trials are typically needed for FDA approval. The randomized withdrawal design was chosen to address the challenge of dose response in neuropsychiatric indications like depression and to tease out the drug effect while minimizing placebo response, given the prior study showed a pronounced antidepressant effect in the active arm.

“in terms of the reason for the randomized [indiscernible] design, one of the challenges with neuropsychiatric indications and depression in particular is by dosing response. So how do you deal with that? So in the prior studies in the prior study, which we conducted with solriamfetol in this indication. What we saw in the active arm was clearly a very renounced antidepressive effect.”

asked by Benjamin Burnett · answered by Herriot Tabuteau