Hey, everyone. Welcome to Guggenheim Healthcare Innovation Conference. My name is Yatin Suneja. I'm one of the biotech analysts here. Our next presenting company here is Axsome. From the company, we have a few executives, but we will be chatting here with Mark Jacobson and Nick Pizzi from the company. Should I hand it over to you, Mark or Nick, to make some opening comments? How do you want to do it? Sure. Well, yeah, first of all. Go for it. Thanks for having us, Yatin. Really appreciate it, and we're happy to be here, especially now with everything that we have going on to end the year and to kick off the next year, so real quick, maybe Nick can talk about commercial performance, but very pleased. We just reported Q3. We'll go into that strong quarter. We expect that strength to continue, and then just operationally and on the development side, a ton going on. And I'm sure we'll cover it, but there are our NDA stage programs, AXS-05 and AD Agitation, AXS-12 and narcolepsy, and then a number of ongoing or soon-to-be-initiated Phase III programs, so just a ton going on. Recent update where we are building out the earlier stage pipeline, so we can talk about that. That was an announcement last week. So we're just very pleased overall in terms of the company's progress this year and then outlook. And I don't know, Nick, do you want to touch on any of the numbers? Yeah, Yatin, thanks again for having for hosting Axsome here. So Q3 was another strong performing quarter, $171 million in total net sales, led by our soon-to-be blockbuster product AUVELITY in MDD. For the quarter, it did $136 million, which was 69% year-over-year growth, 14% quarter-over-quarter growth. So really pleased with that. And we'll get into it a little bit, but really excited about what the future holds for that product, specifically around how we've been able to execute just with the team that we currently have of 300 reps. But importantly, as market access has continued to evolve. And then also, we've just launched our direct-to-consumer campaign, so national TV campaign. So really pleased about where we are and what's going to hopefully transpire in Q4 into 2026, along with the ADA indication. Additionally, SUNOSI had a very strong quarter as well, 35% year-over-year growth. So pleased with that. Very lean team. We have roughly 70, 74 employees detailing SUNOSI, but that continues to grow. And very pleased that it's meeting a lot of the expectations. And then finally, we launched SYMBRAVO for acute treatment of migraine. And that was we launched that at the end of the second quarter. So this is the first full quarter, had just over $2.1 million. And really nice anecdotal data that we're seeing, as well as seeing scripts growing. So very pleased with all three products thus far. So looking forward to 2026. Very good, Nick. So maybe just let's just touch on the commercial piece first on AUVELITY. Now that you are doing the DTC, can you just talk about the impact? When do we generally expect that impact to come? How should we think about the cadence of patient and maybe the type of patient that might change with DTC? Sure. Yeah, I'll talk maybe a little about the metrics, and then Mark can handle the patient profile, but early data, we're already starting to see the impact of DTC, so very pleased with that, and what do I mean by data? Specifically, the first thing you'll see, let me take a step back, maybe. We launched a campaign early September, so it's really only been live for two months, and the first piece of data that we saw was the Google searches, and that index had peaked based on the history, so we're pleased with that and continues to stay at a high level, so very, very happy with that, but more importantly, as we're starting to see the NBRXs, and that's where we would expect that would be the next main indicator. NBRXs, maybe just a little bit of history on that. The NBRXs were around 2,000 per week in Q4 and Q1. We did an expansion in Q1 by roughly 40 reps to get to the 300, so we saw a 25% increase there in NBRXs, and so it went from 2,000 to roughly 2,500 NBRXs in Q2 and Q3, and then more recently, we've been seeing all-time highs on the weekly. Most recently, this last week, we surpassed 2,800 for the first time, so we attribute that increase from the 2,500 level to the 2,700, 2,800 level, which we've seen in the last few weeks, mostly to the DTC, so super pleased with that, and then really the ROI on the DTC comes with the refills, right? So we would expect to see that ROI into 2026. Got it. Got it. How comprehensive or how big is the DTC from a spend perspective? Sure. Yeah, we're doing it in the Axsome way, where we're not just throwing out $50 million a month in trying to be on every channel. We're doing a very disciplined approach, and maybe a little bit qualitative behind that is in Q2, we did a very small program in certain regions to take a look at, to basically do test markets and see what worked and what didn't work, and then we were able to implement that in, like I said, Q3, Q4. From a dollar amount, we haven't specifically shared from a competitive nature how much we're spending and giving indicators that way. However, what we have shared is that we anticipate our sales in Q4 to meet or exceed the additional spend that we are going to have on DTC, which is really what would be driving our OpEx, along with any additional spend in OpEx and R&D. Got it. Got it. In terms of the type of patient, are you able to, given that the DTC is now live, are you able to have a broader reach, maybe a little bit more? Sure. Yeah. So obviously, when we first launched the product, as with any new branded entrant, you typically see later line use, and that's what we saw, right? You're navigating new-to-market blocks and things like that, or starting with potential prescribers that tend to have patients who are already on some type of treatment, and since the early days, we're now seeing early line use, say, first line or first switch, so first or second line, is about 50% of the patients that are receiving the product. And the latest numbers are mid-teens for first line and the balance second line, and then so that's about 50%. And then it goes from there third, fourth line, et cetera. So that's great, and around a bit over 50%, monotherapy, that's also great, and we expect that trend to continue for earlier line use. So the product performs really well across patient profiles. And that makes sense to us mechanistically. That's what we saw clinically. And that's what we're seeing with real-world utilization. So definitely, as awareness increases, as another element of the sales force, right, is just focus on primary care, nurse practitioners, and things like that. So we expect that also to continue to drive earlier line utilization. What layers onto that is also just the market access evolution. And we've been very disciplined in terms of the type of access that we would rebate for. And so we're seeing access that facilitates or enables earlier line utilization. So we're pleased with that. We expect that to also contribute to additional growth. Just two quick questions on AUVELITY and MDD. Did you talk about the gross-to-net dynamic? I think if I look at the gross-to-net that AUVELITY has is higher than some of the nearest comps, how are you able to do that? And how will that evolve in 2026 or going forward? One. And then the second one is, are there more expansion plans from a sales force perspective just to further accelerate the growth? Sure. Yeah. So Yatin, we announced this past quarter that our GTN for Q3 was in the high 40s. That's a high 40s discount. So that's the first time that we were able to share that we were below 50% from a discount. So really pleased with how that's evolved. But more importantly, that came with 28 million additional lives. So we are now at 85% total covered lives. That's 100% in the government channel and 75% in the commercial channel. Additionally, and this is as important as those 28 million lives came with first line or first switch access. So if you think about everything then, net price is improving, access is improving, and quality of access is improving. So we're really pleased with how that has evolved. We've also shared that we also signed the third GPO. So there's three main national GPOs. We signed an agreement with the third GPO this quarter, so now there's a pathway for those additional, call it 25% of those lives, the additional 25% of lives that are not covered, to be able to have a path forward to coverage, so super pleased with that, and I think your second question was on expansion of the sales force, so we have 300 reps currently. We're very pleased with how we're performing, and I think there's still more room for them to grow, but I would say the next natural expansion of the field force would be with an ADA approval and launch, and there's significant overlap between ADA and MDD, so we'll be sharing more about that in the near term. But as it relates to ADA, and I'm sure we're getting segueing to your next questions, probably, Yatin, is some of the back office team is already in place for Alzheimer's Disease Agitation. What I mean by that is the commercial infrastructure is already established. The medical affairs infrastructure is already established for ADA. So the team is well underway in preparing for launch. And from a field force perspective, we're doing the sizing currently. Got it. Very good. So then we just switch to ADA then. Mark, I think there is still debate from an investor perspective, like what is an approvable package. Maybe it's more clear to you. Can you just explain to us what sort of an agreement you already have with the FDA or what constitutes a successful package for you to file? Sure. And what's great now is the clock is ticking, right? So the cycle started. So we feel we're pleased with that. And we'll all have answers very soon. A package, and so this is feedback from FDA and also matches the statutory requirements, right, is that we need two positive, adequate, and well-controlled trials. And our package includes three. And those are of different trial paradigms, of different durations, and with different types of controls. So that's a very robust, consistent package that we've generated from an efficacy perspective, also from a safety perspective. As a reminder, so the product is approved. This is an efficacy supplement. As a reminder, given the patient population, it's elderly patient population at risk or has additional risks from non-elderly patients. FDA asked us to generate a standalone ICH safety database, right? So not just the initial approval safety database, but another one. We've done that, and we didn't see a signal for falls or mortality and things like that, so in addition to having three positive, controlled, randomized trials, we also have what we think is the data that emerged. There's a really compelling tolerability profile from a risk-benefit perspective in this patient population, so we feel good about that, and all of that matches with the feedback we received from the very beginning of the program and through the pre-NDA meeting outcomes that we announced earlier this year, and so then it's been very consistent feedback-wise and also consistency of feedback matching statutes and guidance, so we like that. So I think your read of the statute is that these are well-controlled studies, different type of study. Basically, the statute doesn't say that it needs to be randomized control or randomized withdrawal. Correct. Yeah. I mean, you could go further, right, in that there is guidance on trial designs for appropriateness of when to utilize, say, designs beyond a parallel group trial, so a randomized withdrawal or relapse prevention trial. There's guidance there. There's guidance on, say, take the guidance for substantial evidence of effectiveness. In there, it states that different trial designs are actually better for controlling type one error than two of the same, right? So there are all different inputs that I think inform our package and pertain to the totality of data that we've put in. Got it. So in the pre-sNDA meeting, you sort of must have reached an alignment or an understanding with the FDA that, hey, look, this is what we're going to present. Because if there was a difference, they would have told you not to. Sure. Yeah. No, definitely, we told them what I've just gone through. That's what we shared was going to be in the package, and so yeah, that's great, and one reason I was kind of highlighting, there's feedback we have from them from the beginning throughout the program. There's the statutory requirements. There's the guidance requirements. One reason that's all important, of course, is it's always a matter of review, and so that's important, so we feel good going into said review. Got it. And then this is a breakthrough designation. Would you expect, at least investors expect you to get priority review? I don't know where you stand on that. It's eligible for it, right? So we received breakthrough therapy designation after the first Phase III, after ADVANCE-1. And we've maintained it. So it's eligible for priority review. What we've shared is we model a standard review. So first of all, both are fast compared to, say, a full NDA, right, given this is a supplement. And the reason we model a standard review is not because of the package itself, but rather just an awareness of other programs that maybe have been eligible for priority review and are maybe getting standard review or just resource constraints at a higher level. And mind you, that's not specific. The agency doesn't tell you one way or another about what they're going to do. However, you know what you're eligible for. And we've now been through a number of reviews. With the first review, I think we have an awareness about timelines and things with that of the FDA. We prefer just to model a conservative approach. Got it. Just maybe one more question, then I want to discuss SYMBRAVO and then SUNOSI. On the market evolution side, I mean, obviously, Rexulti still has its challenges. I think it sort of is an antipsychotic, has that black box. How do you see that market? How is that evolving? Because Rexulti segment, I don't know how much it is growing. Do you want to talk about growth? I can maybe talk about market evolution or. Sure. Maybe I could talk a little about Rexulti and how they're performing, so if you take a look at their growth, so maybe first off, the market's roughly 7 million Alzheimer's Disease patients. 70% roughly face Agitation. So you're talking somewhere in a neighborhood of around 5 million patients, and Rexulti, I think, launched in Q1 of 2023. And they're seeing nice growth in that market. I know qualitatively, they shared that their growth is somewhere in the neighborhood of 20%-25%. And if you actually take a look at sales for Rexulti from that period of time to where they are now, they're essentially doubled. So on a quarterly basis, sales for Rexulti were $400-$450 million back then prior to launching this past quarter, north of $825 million, looking at both manufacturers' financials. So you're seeing the growth. And qualitatively, it sounds like 20%-25% of their total sales are in that Medicare channel and related to Rexulti, related to ADA. Yeah. So maybe just to piggyback off that, so the market's changing, but it's also staying the same. And why? The majority of patients are still treated in an off-label fashion with other atypical antipsychotics, SSRIs, SNRIs. And so that's still the majority of scripts being written. But it's changing because now there's an approved product, right? There's one approved product. So patient profiles are starting to become more formalized, perhaps. And then there's, of course, active promotion in the space, which generates awareness and things like that. So definitely, the market is maybe it's becoming so it is evolving. And Nick talked about the numbers too there. But also, there's still a lot that's steady state because there's only one approved treatment. And so mechanistically, there hasn't been a lot of innovation. Got it. And maybe just furthering, it's helpful for them to be able to obviously educate the market on this disease state. One of the things that how we think about launching an ADA, so as I mentioned, we have the current team of 300 reps. We would likely do an expansion upon an approval that would be focused on MDD as well as ADA. And then we would also focus on long-term care centers. We haven't actually detailed LTCs at all for the MDD space. And there is a lot of comorbidity between MDD as well as ADA. And lastly, as we think about market access, I shared earlier that we were 100% covered in the government channel, which the majority of the ADA scripts would be in Medicare in that government channel. So we feel like coming out of the gate, we're set up really well to perform. Got it. Very good. Then we move to Elyxyb. I think some early uptake that you're seeing right now, just can you articulate how big you think the product could become? How is the access looking? I think the recent quarter of $2.1 million was at least better than what we were hoping. Yeah. So I think maybe I'll start a little bit on it. So $2.1 million in the quarter. We're pleased with how we're out of the gate. Similar playbook to AUVELITY is how we're launching with SYMBRAVO. Excuse me. A very disciplined, discreet field team of 100 reps compared to some of our peers with north of around 600 reps where they launched with. So a very focused approach. We have roughly 50% coverage of lives. And that is an increase from what we shared in Q2. So pleased with that. And the way we're approaching launch is a very targeted effort around headache centers and headache specialists. We were very interested in driving early trial in those areas or with those potential prescribers to see and understand how the product does in a real-world setting. And so far, the feedback from prescribers matches expectations. And the data we generated clinically, which is very robust efficacy, works well. And then with a really nice tolerability profile for said efficacy. And that early utilization, that will inform downstream strategy and tactics, which will pull through. But so far, the early days, we're pleased with the feedback we're hearing. And then we'll do what we do, which is a data-driven approach to expanding awareness and promotion and then obviously potential utilization. How big the product can become? Yeah. I was just going to share that. So we shared previously that $500 million-$1 billion in peak sales. And we feel very confident in that, so. Got it. Then quickly on the narcolepsy, what has been the gating factor for an NDA filing? And then can you just frame for us the market opportunity there? The gating factor is building the submission, so the clinical work is done, and there wasn't ongoing clinical work or data generation, anything like that. It's us running air traffic control on the non-shutdown air traffic control on our programs. It's both our division of psychiatry and things like that, so we've got a complex choreography on our side that we're doing, but really, it's the analysis. It's the writing the modules and things like that. This is a new NDA, so we want to take our time to strengthen it as much as possible and dot all the i's, cross the t's, et cetera, make sure all the modules link appropriately to get really into it, and so I mean, that goes without saying that has to be done, but that's the work that's happening. Okay and then this sort of is an orphan drug pricing. Just can you put in perspective how you think about the market? We haven't guided to pricing yet. But yeah, it's an orphan market. And we have a pretty good sense of where products are priced right now and the range. And there's nothing about the product that we think the product's differentiated in efficacy and tolerability perspective. So there's nothing about the product that would lead us to plan for or anticipate some anomalous type of pricing framework. Got it. It's super synergistic to our current sales force as well. Yeah. So basically, it's a plug and play for our team. Yeah. For SUNOSI, EDS, how is the outlook for SUNOSI in general? Good. Where it could be the product? I mean, the last quarter was good. We did 30, yeah. We did $33 million in the quarter. Nice growth year over year and continue to maintain the $300 million-$500 million guidance in peak sales and that indication with four indications behind it, so that will obviously get a tailwind if any of those indications are approved. Yeah. Very disciplined from a business and investment perspective, right? Sales team is about 70-75 reps. And so it's just incredibly efficient. And the product's growing, as Nick mentioned. Got it. Finally, on the P&L, I mean, I think we estimate that you should reach cash flow positivity next year. Just can you talk about where the leverage is coming from? I think you have to make some investment into ADA if it gets approved, how all of that is going to shake out for next year. Yeah. So quick comment on the quarter. And it's a milestone for the company. It's the first time that we actually hit cash flow positive. And if you take a look at our cash flow from operations, we actually were about roughly $1 million positive for the quarter. So super pleased with that. We'll continue to see operating leverage in Q4 and into next year. I would say if you take a look at where we are currently in the P&L, we had $150 million in SG&A and roughly $40 million in R&D. You would anticipate that DTC spend in Q4 will continue slightly. There will be some stuff that was one time from Q3 that will not be carried into Q4. And then if you think about R&D, we were at $40 million for Q3. We do anticipate to start four trials in Q4 and really fully loaded in Q1 and so forth. So we would expect that $40 million to probably tick up to closer to the $50 million where we've been historically in that $50 million to low $50 million range. So pleased with where we're seeing. But overall, this quarter specifically, we saw revenue grow at 14%. OpEx grow at 5.5%. And that was with a launch, a full quarter's worth of launch for Elyxyb and hitting cash flow positive in that quarter. We feel very happy about. Got it. Very good. Very good. I think that's all I have for you guys. Cool. Thank you so much. Thanks for having us. Yeah. Thank you. Thanks, Yatin. Thank you.