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

Lori Englebert: Hey, Vikram. I’ll take that. So currently, as we’ve mentioned multiple times in as the standard, most of the commercial plans have Auvelity coming in an NDC block, which requires quite an effort to get patients online, which is why we’re really excited about the demand that we’re driving despite these challenges. However, due to that, why the therapy use has been relatively later line right now with about 28% sitting in second line and 61% sitting in third line-plus. The response has been, again, to the question, I answered with Charles, the response has been very, very consistent with label. And to see that in later line patients is extremely encouraging.

Herriot Tabuteau: Just to add, with regards to the second part of your question, as it relates to what we would be looking for with regards to a potential partner for Auvelity in ex-U.S. I think one of the things that we would look for it is partner with proven capabilities, but also a partner that has experienced with regards to navigating the pretty complex reimbursement landscape in certain geographies such as Europe.

Vikram Purohit: Okay. Got it. Thank you.

Operator: The next question is from the line of Jason Gerberry with Bank of America. Please proceed with your questions.

Jason Gerberry: Hey. Good morning. Thanks for taking my question. Are you guys planning to increase enrollment of ADVANCE-2 to get to the 300 patients by six months? I was just doing the math on, I think, what 50 patients from ACCORD went into randomized withdrawal, and the other 175 under the current enrollment plan for ADVANCE-2. So just curious how you get to the 300? And then if you can comment on how we should be thinking about SG&A and OpEx ramp is 4Q 2022 on an annualized basis, sort of a good place to think about some growth off of that number or is there going to be any step-up from there? And then just last question, any comments on any inventory launch stocking here on the fourth quarter number. Thanks.

Herriot Tabuteau: Lori, I’ll take first question, and Nick will take the others. The answer is no, we do not anticipate having to increased enrollment in ADVANCE-2 to meet the required patient safety database. As a reminder, we do have patients from ADVANCE-1, in terms of general safety experience, but then we also have 170 patients, as a reminder, who were enrolled in period one of the ACCORD trial and a lot of those patients and most of those patients went into label safety extension trial. So if you take the patients rolling over from as well as the expected patients from an over from ADVANCE-2 that should put in pretty good shape. Nick?

Nick Pizzie: Sure. Hey, Jason. So related to OpEx guidance, I think like — I think you mentioned using Q4 essentially as a proxy, I think that’s a fair estimate, we stated in the press release that we expect expenses to increase year-over-year. Obviously, with the launch of Auvelity and Sunosi being acquired in the second quarter of this year, we’ll have a full year of SG&A expenses and Q4 being almost a full quarter, I think you can expect view that as a proxy and potentially a modest growth from — on the SG&A piece as it relates to thinking about 2023 on a quarterly basis. And then, I think your other question is, you broke up a little bit, but I think your question was related to inventory channel and where we were at the end of the year.