Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q4 2022 Earnings Call Transcript

Robert Hazlett: Yeah. Thank you for taking the question, all there clarifying comments here. My question is on the smoking cessation program. Could you just frame some of the parameters and timing surrounding the Phase 2/3 there, size of trial, again, timing, endpoints, things like that? And then with regard to the administration dosing of AXS-05, would you expect it’s it to be dosed in similar fashion titration to a top dose as it is in MDD and AD agitation? Thank you.

Herriot Tabuteau: Thanks, Bert, for the question. With regards to the timing, we do expect to initiate the Phase 2/3 trial in the fourth quarter of this year. The team is working very hard to get that done. And sort of the design of the trial, this will be a standard parallel trial design. We will have more to say once we launch the trial as well always do, we’ll provide details in terms of the endpoints that we’re looking at. But rest assured that the endpoints will be registration endpoints. And we have gotten feedback from the FDA on exactly what that will look like, and we will provide those details once we launch the trial. And in terms of the dose recommended we’ll also provide that information once we launch the study.

Robert Hazlett: Great. Looking forward to that. Thank you.

Operator: At this time, we have time for — to take two more additional questions. The next question comes from Myles Minter with William Blair. Please proceed with your questions.

Myles Minter: Hi. Thanks for taking the question. Just wondering how many or what percentage of covered lives are actually represented through the plans that will used at JPR (ph) brought online last month and when you anticipate those plans making those decisions?

Lori Englebert: Yeah. Mike, I’ll take that one. So as updated in the prepared remarks, it was one of the three GPOs that are currently operating right now. Each of the series have a fairly substantial amount of covered lives and the PBMs and plans that are underneath them, now have the ability to access those contractor rates. Once they work through their standard and expect six to nine months NDC blocks. So discussions are active with other — the other GPOs and payers, both from clinical reviews as well as discussions on formulary decisions. We do expect that to be made over the next six months.

Myles Minter: Okay. And then just as a follow-up. Last year, when you met with the FDA and you decided to run ADVANCE-2. I think did they guide that they wanted to see an additional placebo-controlled study for AD agitation because they wanted to see additional placebo-controlled efficacy as well as safety data at that time and that time or commentary changed at the current meeting that you just had? Thanks.

Herriot Tabuteau: Sure. Thanks, Myles for the question. When we made the decision to initiate the ADVANCE-2 trial, that was a decision that we made just from a business perspective. And so that is not based upon requirement or feedback from the FDA. However, once we didn’t meet with safety data, in particular, placebo-controlled safety data as well as safety database based on ICH guidelines that less information that was provided to that will be a requirement for the NDA filing.

Myles Minter: Okay. Thank you.

Operator: Our final question is from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your questions.

Unidentified Participant: Hi. This is Raymond (ph) in for Matt on. Congrats on the quarter and thanks for taking our questions. Just a quick one. I wanted to ask about Auvelity of the DCC platform. You’ve had early success with Sunosi and DCC. I was wondering how DCC in your initial experience with Auvelity kind of driven sales? And any initial learnings that you’d hope to incorporate as the large progresses? Thanks.