Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q3 2023 Earnings Call Transcript

Lori Englebert: Yeah, and of those that are on the market and approved right now, you know, patients have to endure really difficult dosing schedules. They trade off efficacy for tolerability or vice versa. So there is still a high unmet need in this [indiscernible] indication for patients.

Operator: Thank you. The next question is coming from Joon Lee of Truist Securities. Please go ahead.

Joon Lee: Hey, thanks for taking our questions. You know binge eating for solriamfetol sounds like it could be either a niche or a huge opportunity. How are you framing the prevalence and commercial opportunity binge eating in the US for solriamfetol? And I will follow up.

Lori Englebert: Hey, Joon. Yeah, we are also very excited about the potential here for binge eating disorder. It is the most common eating disorder. 7 million is the estimated prevalence right now. Only very, very limited treatment options are available for patients. So again high unmet need in a disease that is incredibly prevalent.

Joon Lee: All right. Looking forward to your event on that. On the narcolepsy study, would hitting statistical significance on cataplexy, but not on excessive daytime syndrome keeping us a good outcome or is it your goal to hit statistical significance on both cataplexy and EDS.

Herriot Tabuteau: The primary endpoint of the study is cataplexy, and we’re not going to speculate in terms of what results would be or could be. We’re close. So you’ll know very soon.

Joon Lee: All right. Looking forward. Thank you.

Operator: Thank you. The next question is coming from Ram Selvaraju of H.C. Wainwright. Please go ahead.

Raghuram Selvaraju: Hi. Thanks for taking my questions. The first one is on binge eating disorder. Can you maybe clarify for us what you expect the competitive landscape, if any, to be for your drug candidate, you know, as and when it might secure a label for this indication?

Lori Englebert: Hey, Ram. Yeah, happy to. You know, right now, again, there is, you know, I think one product available for binge eating disorder generic. It is highly prevalent SSRIs, SNRIs being prescribed for the disorder. So we think we have an opportunity to really differentiate ourselves clinically in the marketplace.

Raghuram Selvaraju: Okay, great. And then can you just refresh my memory regarding, you know, your timeline with regard to smoking cessation and ultimately if you could just kind of sketch out for us strategically, assuming a label in that indication, ultimately how you expect promotion activities, sales and marketing activities for that indication to dovetail with what you already have in the field?

Herriot Tabuteau: There is an obvious overlap in terms of therapeutic area for smoking cessation and the rest of our psychiatry and neurology pipeline. So we like the concentration. And I think a lot will depend upon the clinical profile as it evolves from our Phase III trials.

Raghuram Selvaraju: Thank you.

Operator: Thank you. The next question is coming from Joseph Thome of TD Cowen. Please go ahead.

Joseph Thome: Hi, there. Good morning and thank you for taking my question. Maybe the first one on the additional 100 person sales force. Can you go into a little bit more detail on the incremental call points? Are these primary care positions or are they additional specialists that you weren’t seeing earlier and given that the staff is going to be hired, the group is going to be hired by the end of the first quarter, should we expect more of like a Q2 impact from that, or how are you thinking about that? And then second, on the core data presented at CTAD, it looked like dizziness popped up as the largest TEAE, but then impressively that went to zero in a double-blind period. So can you just talk a little bit about dizziness with AXS-05? Does this go away with time? And what’s kind of the grade of that AE? Thank you.

Herriot Tabuteau: Can you start?

Lori Englebert: Hey, Joseph. I’ll address the expansion. So as we mentioned last quarter and refreshed everyone’s memory at this readout, we are expanding our sales force from about 26,000 HCP targets to 44,000 HCP targets. That will take a higher number of PCPs into that number, but what we have remained focused on is the highest likelihood to prescribe HCPs. Of those 44,000 HCPs, they are writing 90% of new branded therapies on a weekly basis. So we feel like we have a great opportunity to tap into optimize the growth of the product.

Herriot Tabuteau: Great. With regards to the question around dizziness in the ACCORD trial, your observations are correct. The dizziness was mild. It was transient. It decreased over time and it did not result in discontinuations.

Joseph Thome: Great. Thank you very much.

Operator: Thank you. The next question is coming from Yatin Suneja of Guggenheim. Please go ahead.

Eddie Hickman: Hi. Good morning, Thanks for taking our questions. This is Eddie on for Yatin. Just one from us. In light of the increasing sales force this quarter, how should we think about the quarter over quarter script increases for Auvelity? And do you expect the increased sales force to really increase cadence then or do you think we’ll have to wait until later in 2024 before we see an inflection there? Thanks.

Lori Englebert: Yeah, hey, Eddie. So as we mentioned before, we should have the field hired and trained and promoting by Q1, but it does take a little time for new sales reps to establish themselves and get out there to produce. So we don’t expect any kind of meaningful uptick until later in the year.

Operator: Thank you. The next question is coming from Graig Suvannavejh of Mizuho Securities. Please go ahead.

Graig Suvannavejh: Good morning. Thanks for taking my questions and congratulations on a good quarter. Just wondering if you could please comment on gross to net in the third quarter for both Auvelity and Sunosi and whether third quarter reported sales for both products reflected any changes in inventory. And I have a follow-up please. Thanks.