Morning, everyone, and welcome to the H.C. Wainwright 28th Annual Global Investment Conference. I'm Katherine Degen, I'll be your Moderator for today. It's our pleasure to welcome Mark Jacobson, COO, and Nick Pizzie, CFO of Axsome Therapeutics. Thank you both for being here. Take it away. Great. Thanks very much for having us, and good morning, everyone. Nice to be here and see you all. We're actually going to take you through today, and the corporate presentation instead of a fireside chat. We want to take a moment to really share how the business has grown and where it is in this very, I think, unique stage of development that we're pretty excited about. First and foremost, we will be making forward-looking statements today, or we may be, and we'd encourage you to read a full summary of the risks and uncertainties associated with our business through our filings at the Securities and Exchange Commission. With that, we'll get started. Axsome Therapeutics, we are focused on central nervous system disorders, in particular, highly differentiated mechanisms of action for areas of unmet need or that have been underserved in CNS. That's, we think about it for psychiatry and neurology. The snapshot of the business today is three marketed products: Auvelity, Sunosi, and SYMBRAVO. Auvelity's approved for major depressive disorder, and recently, Alzheimer's disease agitation, which we are launching now. Sunosi for excessive daytime sleepiness and OSA or narcolepsy, and then SYMBRAVO for migraine. We'll talk more about each of those. We have six differentiated product candidates in development across 10 different indications in psychiatry and neurology. We're very pleased with that and the state of the business. We have trials ongoing in smoking cessation, ADHD, binge eating disorder, major depressive disorder with symptoms of excessive daytime sleepiness or excessive sleepiness, and fibromyalgia, and shift work disorder. We have programs that are on deck or in the works for schizophrenia, epilepsy, and we are also looking at Tourette. Then finally, we have an NDA under review with the FDA Division of Psychiatry for our AXS-12 product candidate in narcolepsy. Just the business has never been more robust commercially or in the R&D side. We'll take a quick moment to review recent business highlights. We reported Q2 last month, and Nick, I don't know if you want to cover- Sure, A couple of items on. Thanks, Mark. So, Q2, we did $218.4 million, which was 46% year-over-year growth. That was really led by Auvelity, which recorded revenue of north of $180 million. Auvelity continues to grow. We recently did expand the team from less than 300 reps to north of 600, 630 if you include our long-term care team. And importantly, in the most recent quarter, we received a new indication for Alzheimer's disease agitation, which is a lot of the Street's focus currently, and obviously a lot of focus for us. So looking to continue to build the MDD brand and launch the ADA brand. Great. And pipeline, I touched on some of the ongoing clinical trial work, but just to summarize. So, seven ongoing trials. We have an NDA for AXS-12, which I touched on. PDUFA date is May 1st. Highly differentiated. Again, that starts with mechanistic differentiation that flows into a distinct efficacy and tolerability product profile, and we'll look forward to keeping everyone updated on the progress there. We recently initiated three phase III trials. That's smoking cessation for AXS-05, the SUMMIT trial, and then the two studies of solriamfetol in ADHD. That's in children and adolescents. That's the FOCUS-2 and FOCUS-3 trials. And as a reminder, we have a positive phase III trial in adults that completed, and multiple other programs behind those or complementing those. I touched on the PDUFA date for AXS-12. We then have top- line results that we anticipate for the ENGAGE phase III trial of solriamfetol in binge eating disorder in the fourth quarter. We've also shared that we anticipate top- line from the shift work disorder trial of sarampanadol next year. Cool. Yeah, so a bit about in more detail on the numbers for Q2. As I mentioned, Auvelity led Axsome with $180 million. We've estimated that currently we expect peak sales potential to be $8+ billion, and that's roughly split between MDD and ADA. One of the things to think about is where we are currently. We mentioned $180 million in Q2, and that was really the effect of, as I mentioned, less than 300 reps. We've now more than doubled down. We additionally have market access that is conducive to being first line or first switch in MDD as well as ADA, and access in the ADA channel being every participant in Medicare Part D has access to Auvelity, with north of 85% not requiring a PA and also being unrestricted or first line. We feel really great about the $8+ billion number. One of the things to also maybe just taking a step back: we're less than four years in; we analyze based on Q2's numbers around $750 million, and that was only with 0.25. That's a quarter of 1% of the entire antidepressant market with, as I mentioned, less than half the team that we currently have now. We feel like this is the new chapter for Axsome. I think the first chapter was really successful, but now we're going into more of an overdrive, doubling the team, having the market access, making patients aware through direct- consumer advertising, and we expect to see accelerated growth in the coming years. Maybe just a minute on Sunosi too. Sunosi: $36 million in Q2 revenue, peak sales $300 million- $500 million. SYMBRAVO doing $2.3 million, but did have strong growth in Q2 versus Q1, 30% growth. The story there is just getting payer access. Anecdotally, we've heard nothing but positive feedback on SYMBRAVO, and the demand is showing that positive feedback, but it's just about getting payer access in this space, and we believe the peak sales there for $500 m illion- $1 billion. Financial performance for the quarter. As you can see, the $218 million, 14% sequential growth, 46% year-over-year. Very robust growth year-over-year. Importantly, the OPEX of $46 million and $208 million for SG&A, we anticipate that that number has essentially plateaued, going into the back half of the year. That's meaningful as we are approaching cash flow positivity and then profitability shortly thereafter. The SG&A number fully encompasses the expansion that I mentioned for the sales team for Auvelity. We do anticipate R&D to increase marginally from the $46 million number as we continue to develop the phase III assets that Mark mentioned earlier. The balance sheet is super strong, $320 million as of the end of Q2, strongest and healthiest position that we've been in since inception. We also put on here the shares outstanding: 52 million, which I think, compared to some of our peers that are in that $10 billion- $12 billion market cap and where we are with the current commercial products as well as our pipeline products, we only have 52 million shares outstanding. We've been very sensitive to dilution. Even with the dilutive shares, you're at 60 million total share count, or roughly 60 million, if you include the employee stock option plan. The cumulative deficit for the company is $1.2 billion or $1.3 billion. That is from inception. That is from 2012. Again, a small fraction, just how we think financially about investments and how we deploy capital. If we look at the commercial products, just to be mindful of time, we'll be somewhat abridged here, but Auvelity, obviously, this is what all eyes are focused on, and the feedback we receive from folks like yourselves. But oral NMDA receptor antagonist, this is the first and only oral NMDA receptor antagonist, and sigma-1 agonist for both major depressive disorder and Alzheimer's disease agitation. In MDD, it demonstrates a rapid onset of action, robust and durable efficacy, and a distinct safety and tolerability profile. That's the clinical program we saw. Now, with four years on the market, that's the feedback we get from patients and prescribers: that the drug works really well. It's differentiated from an outcomes perspective or an overall profile perspective, and that we see when patients and prescribers try the product, it leads to very robust adoption. Nick touched on that. We've expanded the sales team. Two reasons for that, and we'll look at growth and prescriptions on the next slide, but that's to drive continued growth in major depressive disorder and then also our new indication, Alzheimer's disease agitation, which was approved earlier this year. We launched it in the summer. The launch really got up and running in June. The field force expansion really completed in June for the community team, and we also added a new team, a smaller portion of sales team members that are fully dedicated on long-term care, which we were not engaging with prior to the approval of Alzheimer's disease agitation. From an advocacy perspective, highly distinct, again, that ties to the mechanistic differentiation, so it has a very important efficacy and tolerability balance, and adverse reaction profile is distinct from other products that are used on or off label. We're incredibly excited about the ability for Auvelity to meet a very substantial need in the market and treatment landscape. When we look at rates of adoption and adoption since launch, just very robust growth. We expect that growth to further continue, and in fact, we do expect inflection as a result of, Nick touched on access, the state of affairs and positive developments and evolution of access, the field force expansion, and then the new indication. So we expect a lot of growth, and what we've shared is we expect to see that growth begin essentially now. So one to two quarters following the completion of the expansion and the launch in Alzheimer's disease agitation. We're starting to see that in new prescribers, new unique prescribers. We're starting to see that in new-to-brand scripts in MDD, especially tying to the second quarter. Now we're seeing it in the 65+ age group, which really corresponds closely and is a good proxy for prescribing in Alzheimer's disease agitation. We expect to see those trends continue. Sunosi. This is our product for excessive daytime sleepiness, and narcolepsy, and OSA. Very differentiated from what's available, and what we'll just share is feedback from prescribers and some data that we have. We mentioned improvements in cognitive functioning. We have the SHARP trial data demonstrating said improvements, and the feedback from prescribers is such that overall global changes that patients experience are very compelling and distinct. That's led us to that multifaceted clinical program for solriamfetol, which we'll cover. As we touched on, the product's been growing since we acquired the product. It's been growing very steadily. The business is very healthy, and we expect that to continue; then we're incredibly excited about additional potential label expansion possibilities. SYMBRAVO, that's our product candidate for the acute treatment of migraine, highly differentiated. We undertook that from a rational development perspective. Many products approved high rates of dissatisfaction with patients and prescribers from an efficacy perspective. That's what we demonstrated in the clinical setting: that the product works very well. It works quickly in terms of aborting a specific attack, but then it has a very long half-life where we see a very durable efficacy and tolerability profile that is compelling for said efficacy. Products are growing, and in particular, we'd like to call attention to the growth in volume. We are navigating, Nick touched on this, the very regimented and dense access barriers and hurdles, and friction, that there's nothing new here for this market, but migraine is a heavily managed market from a payer side. So we're navigating that, and most importantly, this stage of launch, we're about a year in. We really like the demand growth that we're seeing and the feedback that we're seeing that the product profile is very compelling. We're seeing, as I mentioned, we saw 30% sequential growth, and that was with a team of roughly 100 reps. Based on this demand, we decided to increase that team by another 50 reps to 150, and the effect of those additional 50 reps is not shown in this graph. Those are the three commercial products, and we're very excited for the rest of this year and 2027 for continued substantial growth across the programs. If we quickly turn our attention to the pipeline, we'll have to be efficient here. Here's the snapshot of all the programs. I touched on these earlier, but the current state of affairs so one NDA under review. I think the way if we zoom out, what we'd like to share is that we potentially have one NDA filing per year for the foreseeable future into 2031. We expect the pipeline gears to turn. We've had a very effective clinical trial at conducting clinical trials. We expect that to continue. We've done a good job navigating regulatory processes and reviews, and we'll keep at that. If you look at psychiatry and neurology, the potential impact to patients in the U.S. is significant. As mentioned, we're looking at 10 areas of need. That can either be zero to, say, one approved product or indications with multiple approved products, with some type of treatment gap as the area of unmet need. Here you can just see the total breakout of the $8+ billion in annual peak sales potential. This doesn't include the most recent assets that we brought into our BD team of for AXS-17 in epilepsy and AXS-20 in schizophrenia and Tourette syndrome. Really, the main focus right now in the near term is of Auvelity, with the MDD further expansion and growth there, along with the ADA indication, and then SYMBRAVO and Sunosi being our other two commercial assets. The intellectual property position of the company, the approved products, and those in development is very strong. Would just like to highlight for Auvelity, we have completed and have determined the exclusivity period, which runs into the end of 2038 or early 2039, and we expect it to be early 2039, upon receipt of pediatric exclusivity. Sunosi: that runway has also now been established, and that goes into 2040. Both of those programs have defined and established life cycles that are incredibly long, and that ties to our expectations with being able to impact medical practice as distinct treatment options versus available therapy and therapy and development. So we're incredibly excited for both of those programs. SYMBRAVO, the work to establish the period of potential exclusivity is underway. So we'll have updates there, but the patents go out to at least 2045. AXS-12, orphan indication for narcolepsy, and then there's a patent portfolio behind that, and same for AXS-14, with a robust patent portfolio. That's always been a focus for us. That will continue to be a focus, and the commercial business right now has fantastic longevity, which we're very excited about. Finally, we would just like to touch on the innovation that's occurring at Axsome, and that's in the commercial portfolio distinction of the products for their respective approved indications, and then the other programs that are underway. We're very excited about the state of affairs for the business. It's never been better, and we're right on the precipice of our next phase of what we expect to be incredibly robust growth, especially with respect to the prior growth to date. We look forward to keeping you all posted, and thanks for having us today.