Axsome Therapeutics (AXSM) Q2 FY26 earnings call: guidance and Q&A

Can you discuss trends and enthusiasm in long-term care settings for Auvelity's ADA launch, including any successes or challenges?

Early data is encouraging, with strong new-to-brand prescription growth in patients aged 65 and older. Positive feedback is consistent across both community and long-term care settings, though it's too early to provide specific details on care settings.

“we're really encouraged by some of the early data we're seeing, the early patient experience has been very promising. We're seeing strong growth in new-to-brand prescriptions in patients aged 65 and older. And that feedback is consistent from both the community and long-term care settings.”

asked by Leonid Timashev · answered by Ari Maizel

What is the long-term outlook for Auvelity's gross-to-net (GTN) in two years, and what percentage of depression patients are currently treated in the first or second line?

Longer term, Auvelity's GTN is anticipated to remain in the 50s, with Medicare scripts expected to become a higher proportion. For Q2, 56% of MDD patients were treated in the first or second-line setting.

“What we've shared longer term is that we would anticipate GTN to remain in the 50s. And we'll be able to give better guidance probably towards the end of the year as we see this launch grow in ADA. ... we saw about more than half of the patients, 56% were treated in the first or second line setting.”

asked by Marc Goodman · answered by Nick Pizzie

Can you confirm the exact percentage of ADA scripts or samples, discuss conversion rates, and whether current weekly growth is representative or if a faster cadence is expected in Q3?

The company does not share specific details regarding sampling as a proportion of overall demand. Sampling is important for trial and titration, especially for elderly patients, and samples are not reflected in IQVIA data. It's too early to predict future weekly growth cadence, but early indicators are positive.

“We don't share specific details regarding sampling as a proportion of overall demand. But we've been very pleased with the overall demand for samples in the community setting. And again, I think that, that's a very important aspect of the launch to support effective titration for elderly patients.”

asked by Andrew Tsai · answered by Ari Maizel

How does the recent approval of an orexin 2 receptor agonist impact the commercial opportunity for AXS-12 in narcolepsy, and have there been discussions with payers regarding its profile and pricing?

The narcolepsy market has high heterogeneity, so more treatment options are beneficial. AXS-12 offers a differentiated mechanism (norepinephrine), quick onset (1 week), durable efficacy (6 months), and a favorable side effect profile, with potential to affect EDS and cognition. Productive conversations have occurred with payers, but pricing will not be commented on until closer to launch.

“We're excited by the potential for AXS-12 to provide a new and differentiated treatment option for patients living with narcolepsy. ... we've had very productive conversations with payers as they're learning more about AXS-12.”

asked by Pete Stavropoulos · answered by Herriot Tabuteau

How much of the impressive prescriber expansion for Auvelity is driven by neurologists (unique to ADA) versus primary care physicians (prescribing for both indications)?

The Q2 prescriber expansion is largely related to the sales force expansion and predominantly driven by growth within the MDD indication, with primary care being the main driver. While specialists are expected to adopt for ADA as the launch progresses, primary care accounted for faster growth in Q2.

“for this particular quarter, I would say neuros may not be representative necessarily Primary care is the predominant growth driver within Q2 data specifically. Obviously, as the launch progresses in Alzheimer's agitation, we would expect to see more specialists adopt.”

asked by Jason Gerberry · answered by Ari Maizel

How are physicians deciding between Auvelity and Rexulti for ADA, and what are the payer requirements (step edits, prior authorizations) for Auvelity in this indication?

There's a significant need for provider education in the ADA market, as it previously lacked approved products. Providers are interested in Auvelity's clinical profile. At launch, Auvelity has 100% Medicare coverage, and over 75% of patients do not require prior authorization. Access is generally favorable based on prior treatment experience or coverage.

“100% coverage in the Medicare channel. More than 75% of patients do not require a PA. Of course, PAs can still pop up depending on the patient's coverage. In terms of step edits, by and large, we're very pleased that patients will gain access to the albeit based on their prior treatment experience or based on the coverage that they have.”

asked by David Hoang · answered by Ari Maizel