Axsome Therapeutics, Inc Morgan Stanley 24th Annual Global Healthcare Conference

Thanks, Sean. Great to be here.

Sure. For us, it is state of affairs is mostly status quo on the R&D side. We are seeing more products and earlier stage products that are being identified, discovered, and developed in China that are making their way over to the U.S. either in terms of potential business development efforts. We are seeing that, and then maybe another element of R&D is just increased number of third-party vendors or non-clinical, pre-clinical laboratories and beyond that are becoming viable options for R&D efforts. I would say we are seeing those two elements the most and maybe one other item is solriamfetol is of course available, and I am not sure if that is what you are alluding to, outside the U.S. So there is that potential impact, but again, for us, things are status quo.

Sure. We are, and it is across the business. I think as you know and probably behind the question is there are all kinds of ways to implement and deploy AI, and we do that already on the commercial side of the business. So, for data and analytics, how we're modeling, how we're applying those models to sales operations and tactics. Then there are actually tools that we have implemented for the sales team members. So determining next best action or call plans. There are AI engines that we've incorporated into that process. So what does that mean? That's there as a tool to drive efficiency and productivity for sales representatives.

It's also being deployed in other elements of the business, and we haven't talked a lot about it, but there are all kinds of ways where you can use this powerful computing tool to monitor CMC activities or drafting large documents and templating those and having them driving speed to, say, early drafts or QCing large bodies of data that you could expedite that process. So it's showing up in all kinds of ways. There are individual efforts for individuals driving this. There are teams of folks thinking about how to drive innovation at the organization. So it's percolating through the organization, but not anything that we've necessarily disclosed AI innovation plans around. It's all just part of the company's kind of normal state of affairs in doing business now.

Yeah, I'd say probably the one thing it won't necessarily substitute is that face-to-face interaction with the HCP. That's something that the doctors truly value is understanding the product directly from an Axsome representative, and we could just see how AI potentially can support the reps to be even much more efficient and effective.

Yeah, sure. Maybe I could answer that question. Probably, the biggest factor there would be the IRA negotiations that, if and when they do come about, would impact us starting in 2032. The team's already preparing for that and doing the HEOR analysis and publications and so forth to prepare in the event that we do have the negotiations. Additionally, we've already priced into our peak sales model of $8 billion, we would say, a relatively conservative approach or conservative estimate, compared to what some of the outcomes that we've seen thus far.

Yeah. Maybe just to add to that, you had in that list just FDA dynamics. For us, I'm trying to find another phrase besides status quo, but it's generally status quo for us that look, we have the three approved products. AUVELITY, it was recently approved for Alzheimer's disease agitation. So that's launching, and I'm sure we'll talk about that. The other programs that are in development, we've received FDA feedback on, commensurate with those stages of development for any given program. So, we feel very good about our dialogue with FDA and what we need to do to submit additional marketing applications. We have another one under review right now, by the way, that's AXS-12 for cataplexy and narcolepsy. We have a PDUFA date there of May 1st.

Again, status quo on the FDA side, even though we know earlier this year and prior, there were a lot of changes. There are new guidances that are coming out, but again, we feel good for that part of the business.