Everyone, good morning and thank you for joining us for our fifth annual TD Cowen Novel Mechanisms in Neuropsychiatry and Epilepsy Summit. I'm Joe Thelmore, the Senior Biotech Analyst here on the team at TD Cowen, and it is my pleasure to kick things off this morning with the team from Axsome Therapeutics. Joining me today, we have Chief Operating Officer Mark Jacobson and Chief Financial Officer Nick Pizzie. Thanks, guys, for joining us this morning. Maybe just at a high level, obviously you had a lot of great progress over the past year, both commercially and in the development pipeline. If you could just, at a high level, let investors know what they should be expecting at the end of 2025 now and maybe even to the beginning of 2026 as they look ahead. Sure. Good morning. Thanks for having us, Joe. I'm Mark, and I'll actually maybe turn it over to Nick to talk about the commercial side of the business, and then I can speak to some of the R&D efforts if that works. Yeah, sounds great. Joe, maybe just taking a step back into Q2, net sales for the quarter were $150 million, right? Obviously focused heavily on Auvelity, $120 million of the $150 million. Sanofi made up $30 million of that, and then we just recently launched Symbravo. We had about two and a half weeks of launch there, which did roughly around $400,000. A lot to be excited for in the back half of the year. Some of the things that have transpired specifically around Auvelity, we did the expansion in Q1 of 40 reps, and we've seen the return on that investment already. Taking a look at Q4 and Q1 of last year, we're seeing MBRXs in a range of 2,000 per week. Once those 40 reps got their legs under them in Q2 and Q3, we're starting to see MBRXs. We are seeing MBRXs at the 2,500 level per week. We're seeing the efficiency from those 40 reps and also the original 260 being even that much more effective. Super pleased with that. Secondly, we announced that we added 28 million additional lives covered in a first line or first step. Really great coverage. That was announced July 1. Super excited about that specifically for patients. How that transitions into the back half of the year, one of the things that we've shared is from a net price perspective, with this additional lives, with patients being able to actually get drug much easier without having to go through necessarily a PA process and so forth, we're able to actually maintain net price. What that means is from a gross to net perspective, we don't expect any degradation in our gross to net. We've shared that we're in that mid-50% range in Q1, Q2. We haven't changed guidance for the back half of the year. We'll see how claims are adjudicated in Q3, and we'll be able to give an update from that perspective. Most recently, we launched our national direct-to-consumer campaign. That's a national TV advertising campaign for Auvelity, which was launched last Monday. It premiered on the Today Show on Monday morning. We expect to run that through the back half of the year. Super excited about that. We'll start seeing internet searches, Google Trends, hopefully to increase. From there, we should start seeing the MBRXs. Finally, return on the investment would be through the Ts, through the refills. A lot to be excited for specifically around Auvelity. Sanofi continues to do its thing, super healthy business. We're seeing nice growth year over year from that perspective. Symbravo, we launched Symbravo two weeks prior to the end of the quarter with 100 reps. Very discrete field force, very early days, but we've heard anecdotally lots of positive things from HCPs, and we're seeing the MBRXs come through. Really pleased with that. Stay tuned for how that continues to grow. Mark, maybe a little on the clinical side. Sure. Yeah, just commercially, we'll continue to drive growth and make investments as we see are rational. We're really excited for that part of the business. Turning to the R&D and development side and development pipeline, obviously a key focus and key program for us is AXS-05 in Alzheimer’s disease agitation. The latest there is sNDA filing. We've got it to the third quarter, and that's intact, and that guidance remains the same. Likely the next update you can hear from us is an acceptance decision from FDA, and we'll keep everyone posted there and provide updates as there are developments, and we can dig into that, Joe, if that's helpful. We have another NDA submission planned for the fourth quarter. That is AXS-12 in narcolepsy, and very excited about that. Behind those two regulatory items, just a ton as per usual going on on the clinical side in terms of clinical trials. We have four clinical programs for Sunosi that are moving along. We have some upcoming trial initiations in ADHD and major depressive disorder, ongoing studies in binge eating disorder and shift work disorder. There's work for AXS-14 in fibromyalgia. We said we'd launch another trial in that program. AXS-05 in smoking cessation, we plan to launch a trial in that program as well. Just again, a ton going on on all fronts, you know, across functions in the company. We're really, really excited for where things are today and the outlook. Perfect. Great. Definitely a lot to dive in on. Maybe we'll start with the commercial franchise for Auvelity, but maybe can you talk a little bit about what you're seeing in terms of the type of patients that are using Auvelity now and if that's changed at all since sort of the initial commercial experience a couple of years ago. Sure. Right now we're seeing about 50% of the utilization is in first line or first switch, which is great, right? It speaks to where already at this point of the launch, the product can be used pretty robustly as clinicians think is appropriate across the treatment paradigm. That's fantastic. If you look at that, it's about 15%, 16% first line, and then obviously 35%, 34% second line, which is fantastic. It kind of goes from there in later lines. We've seen that increasing over time, steadily increasing over time in terms of earlier utilization. That corresponds to, I think, just a number of things, our commercial efforts and focus in terms of being able to expand detailing to primary care and things like that. Those tend to be HCPs who are seeing earlier line patients. Nick touched on the improvements in access. The type of access we're targeting is to facilitate clinician prescribing decisions, right? If they think a patient earlier in, say, first or second line is appropriate, then we want to make sure access is present to facilitate those prescribing decisions. That's moving along. We've been very steady in terms of making sure we secure access that we think is meaningful, but also sound from a business perspective. That's there. Another way to look at that is monotherapy use. We're seeing, I think now it's a bit over 50% of the product is utilized in a monotherapy fashion, which is great, which also speaks to earlier utilization. Also the potential of the product to facilitate reductions in polypharmacy, which is fantastic. I really like where we are today, and we expect that to just continue to improve in terms of who can use the product earlier in the treatment paradigm and things like that. We'll keep you posted in our investments from a business perspective correspond to driving additional growth in that realm. Perfect. Nick, in your opening remarks, you mentioned kind of three main drivers, first being the commercial sales force, second the new covered lives coming online, and then third the DTC campaigns. Maybe we can break those down individually, just as we see all of those different components come online over the next, and they have already, but over the next six months. For the sales force, do you think you've seen sort of the full impact of the sales force at this point? Is it steady state? When you think about what you're seeing in the field, are you right-sized right now, or would you continue to maybe look to expand? Obviously, with all sorts of application, you'll have to, but just in depression. Sure. Yeah, we have seen obviously that nice increase from 2,000 to 2,500 MBRXs per week from the team. Are we right-sized? I think we're in a good spot as of now. I think the next natural expansion is, I'm sure we're going to talk about more, is ADA. What we have been sharing is that we would look to expand the field force team significantly to the point where we can add on to those 300 reps in primary care as well as in psych areas. Something meaningful from that perspective sometime in 2026. Additionally, I know we're talking more MDD right now, not ADA, but speaking on the field force, we would look to have more of a discrete long-term care tactical field force that just solely focused on LTC centers. We're currently, as a reminder, not even calling on LTCs. It's a completely untapped market right now for MDD for us. Obviously, the indication of ADA. From a field force perspective, I think that would be the next natural expansion. Maybe even take a step back. If you think about what we've done thus far, we started with 160 reps. We went to 260 last year, January of 2024, went to 300 in January of 2025, and we're already annualizing at half a billion dollars, only 11 quarters in. The way that we've invested, and we've always done this since inception, the way we've invested money, and you know when we see return, we will invest that accordingly. We're not just going to go and say, hey, we need 800 reps out in the field and then just have them go run. We try to do a very disciplined approach. One thing I might add to that, Joe, is when you think about the current Auvelity sales team, there's high overlap from a detail target perspective. The team is going through that analysis right now in anticipation of a potential review and potential approval. The work on the commercial side is already underway. Yeah, and maybe just one last point on the field force expansion. I think when we first started, it was heavily psych. The call points were heavily psych, and scripts were like less than a quarter of total scripts were in primary care. Now we're already seeing it at roughly a third. That is going to continue to grow as the field force continues to grow. As territories get smaller, they'll be able to have better breadth and depth. That would be one of the things to be looking forward to in later this year and into 2026. With that primary care call point and doing direct-to-consumer, I know we'll be talking about that, but that comes together very nicely. That's great. Maybe for the last two components, just maybe on a sort of quarter-by-quarter basis, obviously Q3 for neuropsychiatric products can tend to be a little bit seasonally impacted. You are bringing more lives online through the coverage that's starting on July 1. Obviously, just started the direct-to-consumer campaign, which I'm guessing will probably have more of an impact beginning in the fourth quarter. I guess kind of how are you seeing these things, kind of the timing and kinetics of them flow through to your revenues? Yeah, I think you're right on the additional coverage of getting to 83% and the 28 million lives coming on July 1. It's more of a downtime. July, August, people are feeling better. Doctors are taking vacation. Our reps take vacation. Patients take vacation. They're not as compliant with their refills. That being said, we're on the other side now of Labor Day. We'll see how that continues to grow now that we're kind of back into, I'll say, a new year. Everybody's back to school and resetting. We feel that with that additional covered lives, we'll see, again, no degradation in price, easier access. Doctors will feel that there's the actual piece of it, and then there's the perception too. If doctors perceive that they now can write and that we have these national wins, they feel more comfortable putting their patients on Auvelity, and they know that they'll continue to get Auvelity. Previously, we had a very generous patient service program. We try to ensure that patients will always receive Auvelity. When you actually get that payer coverage, there's something more tangible about that from a doctor's perspective. Maybe just one last thing on covered lives. We do, we feel optimistic that 83% is not where, it's not going to be steady state. We feel that there's additional covered lives to be had and hopeful for those additional 17%. That's for the rest of this year, and we'll be able to give an update as things evolve. Perfect. Maybe we'll jump over to Alzheimer's disease agitation. Mark indicated that the filing last update was, we'll follow that in Q3. When you had your breakthrough therapy designation meeting with the FDA, the agency at that time said you would need one additional placebo-controlled study in addition to ADVANCE-1. You now have ACCORD-1 and ACCORD-2, I guess in addition to the support of AID for ADVANCE-2, but that one didn't quite meet the mark, obviously. How have your interactions changed, if any, since that time, given that obviously shakeups at the FDA have been a huge investor and public focus this year? Have you seen any changes in your dialogue at all that would make you think differently about the allocation, I guess? Sure. I think I'll say that in totality for the coming for the overall program and then recently. For the overall program, the feedback and dialogue has been consistent for what the FDA is looking for, which is two adequate and well-controlled trials, positive. We'll be coming with three positive adequate and well-controlled trials. That's been very consistent up to and in connection with the pre-NDA meeting feedback that we announced in April. That's all been very consistent and say focusing on 2025. Consistency there in terms of engagement and feedback on the development program that we ran and the trials we've completed, what studies they're looking for for a determination and assessment of efficacy, for an assessment and determination of safety and things like that. We can talk about those, but again, all very consistent. Looking at 2025, you know it's status quo in terms of our engagements, dialogue, and the division. It's the psychiatry division. This is the division that reviewed Auvelity in major depressive disorder, and that obviously it was approved. As far as we're aware, and yes, changes you know both in staffing or disposition, from our vantage point and interactions, again, things are status quo with you know division director and below reviewers and things like that, project manager interactions. Another way to put that is you know no updates in terms of our approach or perspective on the program, the package, the filing strategy since we you know shared the pre-NDA meeting minutes in April. We're, you know it's status quo. Perfect. I guess based on your conversations, do you believe that the FDA views parallel placebo design studies differently than randomized withdrawal studies? Secondarily to that, how are the KOLs using this information? I do feel like they provide a little bit of a different bout of information for patients and how they would manage patients. I guess how does the agency think about it in your opinion? How have your physician feedback on the two different designs been? Sure. Yeah, no, they are different designs. They generate different data sets. In terms of demonstration of efficacy, you can get that from both, right? That is a substantial evidence of effectiveness question. Then you have other questions, labeling. How does it look from a labeling perspective? How does it look from a KOL perspective? Advance one, that classic parallel group where you can track longitudinal change, separation from placebo and when that occurs, right? We saw that occur at week two, stat sig at week three. Whereas the randomized withdrawal studies, those are where you can assess maintenance of a treatment effect and obviously signal or separation versus placebo, but a different type. You can still demonstrate a treatment effect. We did that. We will have a core one and a core two, both of which were incredibly consistent from a results perspective, also from an activity perspective, consistent with advance one. That is great. The KOL feedback, obviously, that can grow over time, right? As more have experience with the product candidate and potential product, we will call it. Currently, that one helps with thinking about onset, which I think is important with respect to the current standard of care and how patients are currently treated, the tolerability profile associated with that, and magnitude of treatment effect, right? That kind of ties to clinical meaningfulness. We have received good feedback from KOLs with respect to that, but also demonstrating prevention of relapse and agitation symptoms and durability of a treatment effect through the randomized withdrawal study. Another key element that KOLs have flagged is the safety and tolerability profile, which is very distinct and of course very important for this patient population, elderly patient population at risk. Current treatment options have a number of risks associated with those. AXS-05, entirely different mechanism of action and product and molecules, so to speak. We are pleased with the feedback we have received from KOLs. Perfect. What are your latest expectations for how large this market can be? Following on to your last point, Mark, we have heard from our KOLs that the potential lack of a black box warning for mortality for Auvelity versus what we see for Sunosi would be particularly meaningful. I guess are you hearing that as well? How much larger do you think that could make Auvelity versus what we're seeing in the initial launch trends with Sunosi? Yeah, I mean, the feedback about, you know, just so black box or even if it's just more broadly, say, warnings and precautions or the description of adverse events, right? That, you know, and obviously it's specific labeling or what the specific label might look like. Obviously that's getting ahead of ourselves, but you know it ties to the tolerability profile. We saw distinct rates of AEs. We did not see a signal with respect to falls. We did not see a mortality signal. I think that ties to, you know, what you're referring to from a black box for the atypical antipsychotics. That's very good. Nick, do you want to comment on the? Sure. Yeah, we estimated the market size. A total of Alzheimer's patients are around 7 million, and upwards of three quarters of them have agitation. That's around 5 million patients that would essentially need therapy. From a peak sales perspective, we look at this as a significant opportunity, even north of where Auvelity and major depressive disorder is. We've shared peak sales in a range of $1.5 to $3 billion. That's as of today. I think we've typically taken a more conservative approach in how we look at peak sales. We'll see how the product does, assuming approval and once it's launched. Perfect. We'll jump this time to the other programs just for a time, but obviously a lot of focus on that. Best of luck with the FDA. Maybe jumping over to Symbravo, maybe you can talk just a little bit about the initial commercial experience. What sort of patients are reaching for the drug? Through your programs, there is a large pay down component early in the launch. When will we start to see if that kind of flips over into longer term prescriptions? Is that a 2025 event or is that maybe something more that we should look out for for the first half of next year? Sure, maybe I'll take the second question and then Mark can talk about the patients that are trying the drug currently. We do have a robust patient service program. What we've shared is that our copay card will allow, our copay card program will allow patients to try the drug. It's a full buy down for Symbravo. Essentially, a patient goes to their doctor, they maybe get a sample to start with and then try it and then come back and then get a script. That script, if they use the copay card or copay card program, they'll be able to have a full buy down. Ultimately, we're looking for the HCP to then pull through the PA to initiate it, submit it, and then approve it and then have the payer get pinged for that script. I would say for this year, we launched two weeks into or two weeks prior to the end of the quarter, going into the summer months. As you mentioned, Joe, earlier at the top, it's very seasonal in North. We've seen growth and we're pleased with what we're seeing even through that time period. We do have 100 reps that are out in the field as opposed to some of the other GPANs that launched with 600 or 650 reps out of the gate. We are taking a disciplined approach. I would say for this year, this is the investment year. We're looking to drive scripts, drive adoption, develop payer access, similar playbook to Auvelity. At the turn of the year, we'll be able to kind of get a good sense of how the launch is going. Early use. It is early, and there's not a ton of data, but so far, the approach on the commercial side has been to focus on headache centers and headache specialists. With that, you tend to see later line patients, right? These are individuals who have had acute migraine, have made their way from a prescriber or physician HCP perspective to these specialists and centers. They tend to have tried a number of products already, so they tend to be later line. That also matches the new to market block that new brands, new products face from a payer perspective, meaning that payers will drive or force later line utilization. Nick touched on some of the commercial infrastructure or patient support offerings that are in place to match that prescribing dynamic. One thing that we'd like so far is, again, it's early and it's highly anecdotal, but the feedback we're getting in that late line setting, and this is consistent with the clinical data we generated, is that the product works well from an efficacy perspective. It also has a tolerability profile that we're receiving positive feedback on, which is great. We will continue to work to drive trial of the product and we'll be looking for feedback from prescribers on how it does. That will inform, as Nick mentioned, additional investment in the launch. Early days, but we like how we're kind of coming off the launch pad. Awesome. Great. We could go on for another half an hour, but maybe just to end, obviously a lot of development going on with Axsome Therapeutics. You have several clinical, late-stage clinical studies wrapping up and some commercial progress here. I guess the company has done well with the Sunosi acquisition. I guess, are you looking at additional BD, either commercially or in the pipeline, or are you happy with what you have? How are you thinking about that? Sure. We have looked at something that we're keeping an eye on out there. What's great is, as you mentioned, Joe, we have such a robust late-stage pipeline right now. We're always keeping an eye, and the market is a bit volatile right now. We definitely are seeing what's out there, but there's really no need to. We're very happy with that Sanofi acquisition, as you mentioned, and being able to develop Sorienthol for further indications. We'll keep an eye on what else is out there at this point. Yeah, no need to do anything. Perfect. Great. Unfortunately, we are at time, but thank you both for joining us today, and thank you to the investors for tuning in. Appreciate the time, Joe. See you later. Bye-bye. Bye.