Thanks, everyone, for joining us. For this session we have Axsome Therapeutics, and we're pleased to have their CEO, Herriot, with us today. So, I think we'll just jump right into it. And I wanted to start by talking about Auvelity. And the launch there's been growing fairly well. You're seeing steady prescription growth. And I guess, can you talk about how you're feeling about that launch, where you think that launch is going? I guess, how where's the new growth coming from? You know, is it coming are you adding new prescribers, more depth from existing prescribers, community, academic? I guess, how should we think about it going forward and, you know, what the strengths of the launch are right now? Well, first of all, thank you for having us. And it's we're really pleased with the way that the Auvelity launch has been evolving over time. So when we launched the product, initially we were focused on a core group of prescribers. Since then, as you know, we've been able to expand that target list by through our sales force expansion. And the, in terms of, you know, where the growth is coming from, whether it's new prescribers or existing prescribers, it's actually both. So, one, we have seen an increase in terms of depth of prescribing. And what we've noticed from the very beginning is that physicians who try the product, they do see really good results from their patients. And as a result of that experience, they then tend to prescribe Auvelity even more. And we also have seen an increase in terms of the numbers of prescribers. So that's the breadth part. I think that's driven just by natural growth, but also by the fact that we did implement the sales force expansion, which started to yield benefit at the beginning of the first quarter. Got it. And, you know, Auvelity launches, I guess, as a somewhat unique product. It's not in the SSRI, SNRI class. So what's the feedback been like from physicians, from patients? I guess, what parts of the profile appeals most? A couple of things. I think, you know, one is that it is a different class. So, in addition to modulating monoamine, it is the first antidepressant that's orally delivered, which it modulates the glutamate system. So glutamatergic neurotransmission is, very important in terms of not just overall brain function, but, in terms of depression. And so you do have the new MOA, which clinicians do like because it gives them something which is different from the SSRIs and the SNRIs, and actually most other approved antidepressants, which work primarily via monoamine. And we do know that roughly two-thirds of patients who are treated frontline with SSRIs or SNRIs actually do not have an adequate response. So there's a lot of patients who are in need. So it's the doctors and the clinicians tell us that it's nice to have a different MOA. Now, it's one thing to have an MOA, but if it doesn't translate into clinical benefit, then it's not all that exciting. And what's nice about Auvelity is the clinicians are seeing exactly what is in our label, which is that the drug works really well. It works quickly, and also it lasts, at least through the duration of our clinical trials. But then we've also had long-term safety extension trials, which show that the drug continues to work. That's in our clinical trial experience. And it seems that clinicians are seeing that in real-life experience. So the drug works fast. It lasts. And in addition to that, it's very well tolerated. So those are the things which seem to resonate with clinicians. Got it. And you mentioned the sales force expansion, which seems like it's playing out well. I guess, as you continue to think about the launch, are you thinking about further investments, whether that be continuing to build out the sales force DTC campaigns? I guess, are there any metrics that you're looking at internally to think about, you know, gating and staging next steps of investment to grow Auvelity? In terms of the sales force, I think our feeling is that right now it is right-sized. So it does allow us to access the vast majority of prescribers for branded antidepressants. So it's right-sized. And now it's leveraging that sales force expansion, continuing to reach out to new clinicians and to educate them. So that's how we feel about that. With regards to DTC advertising, we are already doing DTC advertising, not the television commercials, which most people think of when they think of DTC advertising, but the more contemporary types of DTC advertising, which are more personalized promotion to patients and to HCPs. Got it. And, you know, on your earnings call, you mentioned a positive development with GPOs, access to the drug. So I guess maybe, you know, just want to start dissecting that a little bit. I guess, where are you now with payer coverage with this new addition? Where do you see that going? How do you think about, you know, adding new lives versus potentially having to give greater discounts to payers to offset that? So right now we're at 70% of covered lives in terms of total covered lives. That's divided into the commercial channel and the government channel. Roughly 100% of covered lives in the government channel and then 48% of covered lives in the commercial channel as of the end of the first quarter. Since the end of the first quarter, you know, we did announce signing another GPO contract. That's the first step towards broadening coverage. The way that the GPOs are structured, as you know, is you have the GPOs and under them you have the PBMs and under the PBMs, then you have the individual plans. It allows those plans to access the contracted rates. We feel really good about that. It shows the progress that we've been making in terms of making sure that the payers are aware of Auvelity and also are contracting with regards to Auvelity. So we fully expect then that coverage is going to continue to expand and improve over time. And that is commensurate also with the clinical need, which we believe that payers are seeing based on the profile of the product. Okay. You know, one of the issues we've heard about with Auvelity is, unfortunately, there's still some compounding going on. I guess, as you work to sign more contracts, make perhaps Auvelity easier to access for patients in the commercial setting, do you expect that to start waning? Are there any things you can do to maybe, you know, educate physicians or payers that, you know, just mixing two components isn't delivering the same benefit of as Auvelity to be able to just capture that that share back? Well, that's not something that we're actually seeing a great deal of. And you can look at the prescription numbers themselves. So prescriptions continue to grow. There are over 100,000 patients who are treated with the product. So, clinicians, especially academic institutions, might do things like experimenting, which is what they do, especially in psychiatry. But this is not something that we're seeing broadly at all. Yeah, that's encouraging. And then I guess thinking ahead, you know, MDD is a space that's been getting a lot more attention from biotechs. We have novel adjunctive antipsychotics coming, better safety profiles. We have new mechanisms working on kappa opioid. I guess, how do you see Auvelity fitting in in the future competitive landscape against new classes, new modalities? How do you think it's going to shake out in terms of lines of therapy? What physicians prefer to use? Yeah, you know, it's MDD. It's a massive clinical need. And you have such a large number of patients. And there's also such a heterogeneity in terms of types of patients. So there will always be a need for agents that work differently. And there I think those agents that do work in a different way, and that do show clinical benefit, and especially if they're well tolerated, they will have a place in treatment. So it's not like, currently, you know, Auvelity is one of two agents that are approved. I mean, there are over 30 antidepressants that are currently approved. So we don't really expect that innovation in the space will ever stop, you know, and we hope that it does not because that would be bad for patients. And in terms of where it might fit into the landscape with newer agents, I think we need to see whether or not those agents actually do pan out in late-stage clinical trials, what the eventual profile is of those agents. And that will tell us where they might fit into the treatment landscape. But in terms of as it relates to Auvelity, we don't think that any of that changes the prospects for the product, based on the fact that it is approved and the label that we currently have, and the fact that clinicians are actually seeing that in real life, the clinical benefit is commensurate with what is in the label, at least. Got it. So I guess maybe just following up quickly on that, I guess, is your sense that psychiatrists and PCPs who prescribe for MDD are they more the kind of physician who pick a drug that they have experience with? So a few years down the line, when they've been using Auvelity, they're comfortable with, they're going to stick with Auvelity. Or do you sense that they're, you know, the kind of physician that wants to try a new agent, and so they'd be more likely to switch or try adding something on from a newer class that might start displacing Auvelity? I think that clinicians want their patients to do well. And so if a patient is doing well, then there's really no need to switch them, but I think switches do occur if patients are not doing well. Got it. Okay. Maybe pivoting to Alzheimer's agitation, which is another large and exciting indication for Auvelity. I guess maybe if you could just give us a quick overview of what the landscape is, I think, how much more education you think there needs to be done about, you know, the potential benefits of a drug like Auvelity versus what's standard of care, which is often off-label atypical antipsychotics. We're really pleased with the product profile thus far that we've seen in two completed positive trials. So ADVANCE-1 and ACCORD-1. And what we've seen is, that there is a rapid response. There's a durable response and that the drug is very well tolerated. So that's a great profile and one that, you know, we hope will continue to be replicated in the ongoing clinical studies. You know, as we think about those clinical studies, you're currently enrolling the ADVANCE-2 study, which had somewhat of a delay in timelines. I guess, can you talk about how enrollment there's going, how confident you are that this is going to read out in the second half? So enrollment is going well and based upon the current enrollment trends, we're confident that it will read out in the second half of the year. So that is still our guidance. And with regards to the rest of the program, you know, we did announce that we did start the ACCORD-2 study. And that adds a fourth randomized controlled trial to the clinical program. So we're very happy about that and also the ability to leverage the studies that were already ongoing to make sure that trial enrolls. And so now, you know, we have a clinical program which will, at the end of it, give us four randomized controlled trials as well as a very large patient safety database. Got it. And so I want to narrow down on ACCORD-2, as you mentioned, study recently started. I guess, can you talk about what the impetus of starting that trial was? I guess, what drove that decision? Was it something you came to internally? Was it, you know, from a strategic perspective? Was it something from FDA regulatory discussions and not necessarily something the FDA asked for, but maybe your sense of what ultimately the data package should look like? I think it made sense for us to, and it always makes sense to have as robust of a clinical program as possible. This is a very important drug, we believe, for a very important disease with a high unmet medical need. And so we will be, assuming that everything goes well and the product is approved, we would be essentially the first new drug, I would say, for the treatment of Alzheimer's disease agitation. And there is currently a drug which is approved, but that drug is an atypical antipsychotic. And as you know, atypical antipsychotics were being prescribed off-label for the treatment of Alzheimer's disease agitation. So this is a breaking new ground. And we want to make sure that we go in with as robust of a package as possible. There was also the opportunity to enroll that study very quickly. So that study will complete enrollment. We predict in the middle of this year. So, it and the reason for that is we were able to leverage a very large number of patients in the open label safety extension trial who were being treated anyway, with Auvelity and to feed into ACCORD-2. So, it's efficient. It bolsters the clinical program. And also, if the product is eventually approved, that'll be an additional source of data for commercial activities. Got it. And speaking of commercial activities, I mean, as you mentioned, there is a branded agent recently launched into the atypical antipsychotic market. Is anything you're seeing about the dynamics of that launch that's informing you about how that market is developing, how, Auvelity may eventually launch or take share in that market, you know, sort of what the physician feedback is? So I think that if you look at the interest level from clinicians, it's very high. The launch of the recent product bears that out. So clinicians really want to learn more about how to treat this disease. But it's I think the impact is somewhat muted by the fact that it is still an atypical antipsychotic. So we're hearing that there are some hurdles that still need to be crossed, as it relates to adoption based upon that. So, as you may know, in nursing homes, there is a trend towards reducing the use of atypical antipsychotics in the elderly for other reasons, such as safety. So, the clinicians, they don't have a new product which is, I would say, which necessarily checks all of the boxes all of the time. So they still do need to make these decisions. So, now, you know, we're not as close to it as the sponsor for that product, but these are some of the things that we're hearing. And we don't think that AXS-05 will have those types of hurdles to overcome. Got it. And I know it's still probably early days, so maybe only preliminary thoughts on this, but what would you need to resource the launch for AXS-05 and Alzheimer's agitation? I mean, is the current salesforce that you have across Sunosi and Auvelity leverageable? Would you want to build out something new to go into nursing homes and target specialists? And any early thoughts on what that launch might look like from your perspective? Yeah, so there's a lot of work that needs to be done with regards to making sure that we launch a product like that effectively. However, if you think about who treats these patients, so, patients with Alzheimer's disease agitation, the behavioral symptoms are treated by psychiatrists. Those are the physicians currently which we are targeting and which we are detailing for Auvelity. So there is definitely overlap, which we will definitely leverage the current infrastructure and sales force as it relates to a potential launch of AXS-05. Got it. And then just curious on the IP life around AXS-05 and the combination that you have. You've got a series of 2034 patents. You've got a series of 2040 patents. Some of those later patents are being challenged in court. I guess, how confident are you that you can extend exclusivity, I guess, first to 2034 and then perhaps even beyond 2034? I mean, can you just talk about your intellectual property portfolio? Yeah, we're very pleased with our intellectual property portfolio and the strategy there. So you mentioned that we have patents that go out to 2034 and also ones that go out to 2040. So since the patents were challenged, we've also added new patents to the Orange Book. So there's one family of patents that go out to 2041, and then there's also another family of patents that go out to 2043. So the patent portfolio continues to expand and continues to lengthen the period of exclusivity. Got it. I wanted to pivot to Sunosi. Maybe you can start on the current indications that it's approved in. I guess, how are you thinking about what its opportunity in narcolepsy and sort of the sleep disorders currently is? There's a bit of a slowdown in the first quarter. I mean, is that a blip or is that indicative of, you know, market trends or maybe patient preference for Sunosi? So the first quarter is always typically one would say the worst quarter, just because of seasonality. However, you know, even with that, there was very good year-over-year growth for the product. So in terms of the current indications, we're very excited about the current indications because the markets are large. But we're equally or even more excited about the upcoming indications that we're studying in several phase III clinical trials. So as you know, the product is currently in a phase III trial for ADHD, and we expect that to read out in the second half of this year. We also launched a phase III trial in major depressive disorder, and we expect for that to read out in 2025. Also a phase III trial in binge eating disorder, and we expect that to read out in 2025. So a lot of potential new indications, which we're excited about, to actually significantly broaden the potential for Sunosi. Got it. And, you know, I think you mentioned a lot of potential indications for Sunosi. How are you thinking about, you know, just based on the mechanism, some of the TAAR1 activity that it has, about which of these indications do you have, I guess, the highest confidence that it can work in as the ones that, you know, if you think about your trial structure now, you know, the ones you really see as being the major value drivers for the drug? We think that there are very good mechanistic reasons to study the drug in all three of these indications. So now, in terms of the ones that we have the most data on currently, I would say we do have proof of concept data in ADHD with Sunosi in humans. There is a phase I trial, I'm sorry, phase II trial, which was a single-center study that was conducted with the product. So it's a single-center trial. So there are a lot of caveats there with regards to that. But we do think that those results do support the mechanistic rationale for going after ADHD. Got it. You guys have a really rich pipeline, actually. And so another one of your products, AXS-12, recently had positive data in, also in a sleep disorder. I guess, can you talk about what the remaining steps there are ahead of an FDA filing, and then getting that drug to market, and then ultimately how you see that playing in that area where you also have Sunosi as a complementary drug? So, AXS-12, we did announce positive results from the SYMPHONY trial. And as a reminder, in the SYMPHONY trial, we saw a rapid and significant improvement in terms of cataplexy symptoms. We saw an improvement in the severity of excessive daytime sleepiness. And we also saw an improvement in terms of cognition. So we really like the profile of the product. The clinical responses were significant. So, we looked at remission, for example, of cataplexy, which occurred in a third of the patients. So very robust results there. And in terms of what remains for a potential NDA filing, the major gating factor is conclusion of the open label safety extension trial. And we said that we expect that to complete in at the end of this year. So those are the major, I would say, boxes that we would have to tick that would allow us to then put together an NDA package and submit that. Got it. And then you also have AXS-07 and AXS-14. Sounds like all the clinical conduct there is complete and you're just working on putting together filing packages for the FDA. I guess, are those both on track for submission? And then given sort of how close they are to submission, potential commercialization, how are you thinking about, you know, building those products out for commercialization as well, given, you know, you're potentially going to be launching, you know, four products, five products in a short amount of time? Yeah, so we're still targeting resubmission of the NDA for AXS-07 and submission of the NDA for AXS-14 in the second quarter. So, there are no roadblocks there. And so the team is. These are very large submissions, especially the NDA for AXS-14. And the team is working really hard to make sure that those get in in a quality way. And as it relates to commercialization, so for AXS-07, we will be targeting headache specialists. And for AXS-14, we're doing a lot of work to figure out how to effectively target the prescribing physicians for AXS-14 and fibromyalgia. Got it. Lots more to cover. Unfortunately, we're out of time. So thank you so much for being here. Really appreciate a really informative discussion. Thank you.