Hello, welcome to the Axsome Therapeutics second quarter results conference call and webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question-and-answer session will follow the formal presentation. You may press star one at any time to be placed in the question queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Mark Jacobson, Chief Operating Officer at Axsome Therapeutics. Please go ahead, Mark. Thank you, Operator. Good morning, and thank you all for joining us on today's conference call. This morning, we issued our earnings press release, providing a corporate update and details of the company's financial results for the second quarter of 2023. The release crossed the wire a short time ago and is available on our website at axsome.com. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety, and intended utilization of our investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development plans, our commercial plans regarding SUNOSI, Auvelity, and our other pipeline products, revenue projections, and possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today's date, and the company disclaims any obligation to update such statements. Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer, Nick Pizzie, Chief Financial Officer, and Lori Englebert, Executive Vice President of Commercial and Business Development. Herriot will provide an overview of the company and progress made in the second quarter of 2023, as well as key upcoming milestones. Following Herriot, Nick will review our financial results, then Lori will provide a commercial update. We will then open the line for questions. Questions will be taken in the order they are received. With that, I will turn the call over to Herriot. Thank you, Mark. Good morning, everyone, thank you for joining Axsome Therapeutics second quarter 2023 financial results and business update conference call. In the second quarter, we continued to execute across all areas of our business. We drove continued success in the commercialization of Auvelity and Sunosi, advanced our late-stage product pipeline, and further solidified our financial foundation through a public equity offering that provided us significant operational flexibility and strength. Total net product sales in the quarter were $46.7 million, driven by strong performances from both Auvelity and Sunosi. Based on the growing Auvelity prescription trends to date and positive feedback from clinicians, we are increasing the Auvelity field force by nearly 100 representatives. In conjunction with our Digital Centric Commercialization, or DCC platform, the expansion should nearly double the number of prescribers we are able to reach. Later in the call, Lori will comment further on our commercial performance. Nick will provide additional details on our financials. In conjunction with the commercial performance, our first-in-class development pipeline continues to expand and advance. With respect to solriamfetol, our dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist, we recently initiated the focused phase 3 trial in ADHD. Today, we are pleased to announce the launch of 2 new high-value potential indications for solriamfetol: binge eating disorder and excessive sleepiness associated with shift work disorder. Binge eating disorder is the most common eating disorder, affecting approximately 2.8% of US adults. There is currently only 1 FDA-approved product for this indication. We recently received positive pre-IND meeting feedback from the FDA for this program and are preparing to initiate a phase 3 trial in patients with binge eating disorder before the end of this year. Turning to shift work disorder, an estimated nearly one-third of Americans perform shift work, of whom 10%-43% are diagnosed with shift work disorder. There are currently only two FDA-approved products for the treatment of excessive sleepiness associated with shift work disorder. We also recently received positive pre-IND meeting feedback from the FDA for this program and are preparing to initiate a phase 3 trial in shift work disorder in the first quarter of 2024. The target indications of ADHD, binge eating disorder, and shift work disorder have the potential to dramatically increase the number of patients solriamfetol could help if successful in clinical testing, further growing our already first-in-class CNS pipeline. Stay tuned for more updates on these programs and the rest of our leading late-stage CNS pipeline. We are excited by the number of value-creating opportunities that lie ahead of us. We anticipate completion of the phase 3 SYMPHONY trial of AXS-12 for the treatment of narcolepsy in the 4th quarter of this year. We continue to see steady enrollment in the phase 3 ADVANCE-2 trial of AXS-05 for the treatment of Alzheimer's disease agitation, and we remain on track to complete ADVANCE-2 in the 1st half of 2024. We are making progress towards initiating a planned phase 2, 3 trial of AXS-05 in smoking cessation, which is scheduled to start in the 4th quarter of this year or the 1st quarter of 2024. The team is nearing finalization of the work for the resubmission of the NDA for AXS-07 in migraine. This work has moved at a slower pace than anticipated, and as a result, we now expect to resubmit the NDA in the 1st half of 2024. With respect to the planned NDA submission for AXS-14 for the management of fibromyalgia, we are making good progress and are working to finalize the content and datasets that will complete the submission. We are tracking to an NDA submission in the fourth quarter of this year to the first quarter of next year. Each of these potential milestones builds value for our stakeholders, and we continue to make strategic decisions to maximize the potential for future growth. Lastly, we recently closed an underwritten public offering of common stock that resulted in $258.8 million in gross proceeds, fortifying our financial foundation and providing additional flexibility to execute on multiple fronts. Not only expanding commercial activities by strategically expanding our field force, but also by adding the aforementioned new indications for solriamfetol that may serve to maximize the product's potential. Lori and Nick will each discuss in further detail how the financing amplifies our ability to create value across our portfolio. All in all, we expect a productive second half of 2023 that sets us up for multiple milestones over the next 12 months. I will now turn the call to Nick, who will provide details of our financial performance. Thank you, Herriot, and good morning. Today, I will discuss our second quarter results and provide some financial guidance. Total revenue in the second quarter of 2023 was $46.7 million, consisting of net sales of our two commercialized products, Auvelity and Sunosi, and royalty revenue from Sunosi sales in out licensed territories. Revenue for the comparable period was $8.8 million, comprised of U.S. Sunosi sales beginning May 9, 2022. Auvelity net sales in the quarter were $27.6 million, representing 76% sequential growth. There were no net sales in comparable 2022 period due to the timing of the launch. Sunosi revenue for the quarter was $19.1 million. U.S. Sunosi sales were $17.8 million. International SUNOSI revenue was $1.3 million, including approximately $700,000 in royalty revenue from SUNOSI sales in the out licensed territories. SUNOSI's net sales for the comparable period were $8.8 million, consisting of U.S. sales beginning May 9th of 2022. Cost of revenue was $4.6 million in the second quarter, compared to $1 million in the prior year period. The increase reflects the higher product volumes for both Auvelity and SUNOSI in the current year. Research and development expenses were $20.6 million in the second quarter versus $15.8 million for the comparable period in 2022. The increase was primarily related to higher personnel costs associated with supporting ongoing clinical trials, post-marketing commitments for SUNOSI and Auvelity, and non-cash stock compensation expense. Selling, general, and administrative expenses were $78.9 million for the second quarter versus $31.2 million for the comparable period in 2022. The increase was primarily related to commercial activities for Auvelity and Sunosi and higher non-cash stock compensation expense due to the build-out of both commercial teams. Net loss for the second quarter was $67.2 million, or $1.54 per share, versus a net loss of $41.4 million, or $1.06 per share for the comparable period in 2022. We ended the quarter with $437.1 million in cash and cash equivalents, compared to $200.8 million as of the previous year-end. Ou rsecond quarter cash balance reflects the net proceeds received from our common stock public offering completed in June. In connection with this public offering, in July of 2023, the underwriters fully exercised their option to purchase an additional 15% of the offering, resulting in additional gross proceeds to Axsome of $33.8 million. Inclusive of this event, the pro forma June 30, 2023, cash balance was $469 million. I will now turn the call over to Lori, who will provide a commercial update. Thank you, Nick. Good morning, everyone. In the second quarter, both Auvelity and Sunosi delivered strong growth results. For Auvelity, we are still early in the launch phase and focused on executing our commercial strategy. With that said, early adoption by prescribers is robust and a promising indicator of future success. For Sunosi, the second quarter of 2023 marked 1 full year of Sunosi being commercialized by Axsome. We have begun to see the results from the relaunch of Sunosi, which is resulting in healthy growth quarter-over-quarter. We expect a strong performance for both brands to continue in the second half of 2023. The second quarter represents only the second full quarter for Auvelity. We are pleased with the progress we are making with the launch. Important key indicators of the success of a launch are script growth, new patient starts, and HCP adoption.... In Q2, approximately 53,000 prescriptions were reported for Auvelity, representing a growth of 72% quarter-over-quarter. In the second quarter, HCPs wrote prescriptions for 17,000 new patients, bringing the total number of unique patients on Auvelity to over 38,000 at the end of Q2. This prescription growth came from both an increased depth of prescribing with our early HCP adopters, as well as an increased breadth of new prescribers. In the second quarter, we added approximately 3,700 new first-time prescribers of Auvelity, increasing the cumulative total number of prescribers since launch to over 9,700. About 40% of our initial target universe has written Auvelity after only two full quarters. In response to this early success, we are expanding the Auvelity sales force from 162 to 260 specialty account managers. The expansion is expected to significantly increase our reach from 26,000 prescribers to approximately 44,000 prescribers, who currently write more than 80% of branded antidepressant prescriptions. We believe that the expansion will help build on early success and accelerate launch uptake. With regard to payer coverage, we currently have coverage established for 68% of all covered lives. In the commercial channel, which is expected to be the primary channel for Auvelity, coverage is now at 46% of covered lives, and we look forward to additional formulary decisions in the coming months. In the Medicaid and Medicare channels, approximately 100% of lives are covered. Major depressive disorder, or MDD, is highly prevalent and a major public health concern in the mental health crisis that the U.S. is currently facing. We are proud that Auvelity is providing an important and clinically differentiated therapeutic option for patients living with this chronic and devastating condition. Turning to Sunosi. As mentioned previously, the second quarter of 2023 marked 1 full year of Sunosi being commercialized by Axsome. In the second quarter, we launched our Full of Full Days campaign for Sunosi, which was a complete redesign and updated promotional campaign. We significantly invested in HCP and DTC-directed media with the updated campaign and are seeing immediate results from these promotional efforts. Total prescriptions for Sunosi in the US grew 15% year-over-year and 8% quarter-over-quarter, with net revenues that exceeded expectations. Since Q2 of last year, we have added greater than 13,000 unique new patients, which represents an increase of approximately 30% in cumulative unique patients over the past year. The field team is working to drive both depth within the current prescriber base and breadth by adding new prescribers. Since Q2 of last year, we have increased unique new writers of SUNOSI by 24%. Payer coverage for SUNOSI remains broad, with 95% of commercial lives and 83% of total lives covered. The growth potential for SUNOSI in the currently approved indications remains substantial, as well as its growth in potential new target indications such as ADHD, binge eating disorder, and shift work disorder. As a reminder, SUNOSI is the first and only DNRI for excessive daytime sleepiness in obstructive sleep apnea and narcolepsy, and the first and only wake-promoting agent proven to improve wakefulness through 9 hours. Sunosi is the only branded therapy available for patients who suffer from EDS and OSA, and we expect our increased and enhanced promotional and disease education efforts to drive continued growth for the product in 2023. Q2 of 2023 saw the continuation of a strong launch of Auvelity and the continued execution of the relaunch efforts of Sunosi. Both products are clinically differentiated and address patient populations with high unmet need. We remain focused on commercial execution and expect continued commercial success for both products in the second half of the year. I will now turn the call back to Mark to lead the Q&A discussion. Thank you, Lori. Operator, may we please have our first question? Thank you. We'll now be conducting a question and answer session. If you'd like to be placed into question queue, please press star one on your telephone keypad. You may press star two if you'd like to remove your question from the queue. One moment please, while we poll for questions. Our first question is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live. Yeah. Hey, good morning, Herriot Tabuteau and team. Thanks for taking our questions. Wanted to, first of all, start off with a congratulations on the strong revenue performance, as well as the broadening of pipeline progress. So nice, nice quarter. Couple of quick questions. First of all, with regard to an approval of a product candidate in postpartum depression, but not major depressive disorder, I guess I'm wondering if that changes your views on the competitive environment for Auvelity, if you can give us a sense of what most interests prescribers in its clinical profile, Auvelity's clinical profile, and why they're, you know, really prescribing the drug? ...thanks, Charles, for the question. In, in terms of, you know, what it changes for our business and for, for what we're doing, it, it does not change our plans at all. As a reminder, major depressive disorder is highly prevalent. There are 22 million patients out there. What we've seen with the launch thus far of Auvelity is that the clinical need is, is really great. We've always anticipated that there would be space for multiple players. You know, as we've said in the past, you know, we, we also think that it's good that a lot of different drugs are being developed for major depressive disorder, because we want to make sure that patients get served and that clinicians have options. That's our passion. you know, I, I, I know, you know, why you're asking the question, and I know that, that, that, the sell side likes to pit companies against each other. Let me just say that, that we here at Axsome, you know, we view folks at other companies in CNS as colleagues. We commend the Sage team for their work to provide a new treatment to patients with postpartum depression. We know from experience at Axsome that developing a new drug and getting it approved is really difficult, especially in CNS. It takes the hard work and dedication and passion of a lot of talented individuals. That's what brings us in every day to work. To that end, we are going to continue our work to make sure that we provide new treatments to patients, not just with depression, but also with other CNS indications. If you look at the expanded general pipeline thus far, as we announced today, it brings the, excuse me, total number of patients that we can help to 152 million patients in the US. That's helpful. If I could ask just one follow-up regarding AXS -07 or AXS-07. In migraine, I'm just wondering if you could provide any more color on the work streams required to enable the NDA filing, and also just remind us on the target product profile that you envision for the candidate that will serve an unmet need in migraine. Thank you. Hey, Charles, this is Mark. I'll answer. Hey, Charles, this is Mark. I'll answer the first question about the work streams for the NDA resubmission. Just to be clear, this is just taking us longer than expected, and it's not as though there was some setback since the last call that's going on behind the scenes. We're taking our time to get this right. And what it is that we need to get right are finishing and additional batches that were requested of us by the FDA. As a reminder, the drug substance and drug product are new. The manufacturing, it is a cyclodextrin ring stabilized with a buffering system. This is an Axsome innovation. It is a MoSEIC technology, so that's FDA asked us for additional data to support the package. That, that work is underway. It's just taking longer than expected, and we remain confident that we'll be able to get it done. I'll pass on for the, the product profile. Right. Yeah. So just, with regards to the, product profile question, that you asked, Charles, in, in the second part of your first question. Lori? Yes. So Charles, I'll, I'll switch back to Auvelity, and answer the question on, on the most, what most interests physicians, but then I'll also answer the, the competitive piece on, on those other, if helpful. Thanks. Sorry about that. What most interesting, you know, what's, what we're seeing out in, in the real world is I would, I would say three things. One, obviously the, the rapid onset of action, is, is really impressive to HCPs, and we are seeing results very similar to what we saw in the clinical trials. The second piece is, we are, are, you know, getting to a point now where, we have enough patients on therapy, where the durability is really starting to come through, the sustained effect of, of the product, and so that, that's really encouraging also, to physicians. You know, we are able to, to have a, a, a very large number of patients achieve remission, and that, that is something that physicians are commenting on quite a bit on how fast not only do symptoms improve, but we are able to achieve remission. Again, everything is very similar to what we're seeing in the clinical trials or what we saw in the clinical trials with, you know, remission as early as 2 weeks. The last thing is, is the side effect profile. The side effect profile is obviously favorable versus some of the competitors out there, and physicians and patients are both commenting on that. In terms of AXS-07, you know, the, the, as Mark was, was mentioning, the MoSEIC technology really does allow for that very early onset of action for, for, for patients to, to reduce pain. Despite the fact that there are multiple entrants in, in the, the category right now and a lot of activity, and a lot of promotional dollars, even now, more than 70% of patients still are dissatisfied with their current therapies. We know they cycle through therapies looking for something that's efficacious. We hope to, to bring this up into market as a, as an option for them. Regarding Auvelity, you point out three key differentiations from Zurzuvae base. Thank you for the added color and congrats on the quarter. Thanks, Charles. Thank you. Next question is coming from Raghuram Selvaraju from H.C. Wainwright. Your line is now live. ... Thanks so much for taking my questions, and congrats again on the quarter. I just wanted to ask a little bit about the kinetics of the sales force expansion for Auvelity. Within what time frame you expect that to be concluded? If you expect that new expanded size to effectively be the steady state for the sales force for the foreseeable future, or if any further expansion might be on the cards. And also, if you could perhaps comment on the sales force composition, and, you know, what you see as the facility with which you're going to be able to execute those new hires, from a pool of candidates who have prior CNS or antidepressant sales experience. Thank you. Hey, Ram. Thanks. Sorry if I don't get all of them. I did try and write down every question that you asked, so if I miss something, please, please remind me. Yeah, we are intending to, to have the, the expansion rolled out and, and completed and, and, and ready to, to perform in Q4. We are very much underway in building, in building that expansion right now and have been for, for, for a little bit. You know, part of the reason why we, we think and believe so strongly that the expansion is needed right now is we are seeing such early success. You know, we have 10,000 HCP writers, 40,000 new patients or patients on, on therapy right now. We're adding about 1,000 HCPs or more than 1,000 HCPs every month. What we're seeing and why we're so encouraged is obviously, field forces at this stage of launch, typically struggle between depth and breadth. We are trying to achieve both. Right now, you know, greater than 40% of our target list has already written, and remember, our target list is a very substantial target list, with, you know, a, a very small sales force. Also, of those 40% that have already written, 60% of those writers have found more than 2 patients already to, to write. That's really encouraged from both a depth and a breadth standpoint, and, and we think that, that expanding the field force will, you know, will further accelerate the, the launch uptake. In terms of composition and pool of candidates, you know, our, our first recruit, I think we had greater than 90% with, with CNS experience, more than that with psych experience. We are obviously going to, to, you know, that is our goal for, for, you know, this expansion team as well. Thank you. Thank you. Next question today is coming from Joon Lee from Truist Securities. Your line is now live. Hey, congrats on the strong quarter. Thanks for taking our questions. Any particular reason why the SYMPHONY trial in narcolepsy got pushed out to fourth quarter? If by trial completion, you're also referring to, you know, completion and data readout or just the trial completion itself. Also similar to Alzheimer's agitation, if by completion of trial in first half of next year, we can also expect data in first half of next year. Thank you. I have a quick follow-up. Hi, Jun. Thanks for the questions. With regards to SYMPHONY, we're on track to complete the study and report results out in the fourth quarter. This is not a change from our last update. The reason for the granularity around the timing of the AXS-12 trial is that this is an orphan indication, and orphan indications, they're lumpy. You know, we try and provide granularity as we get closer. We're on track there. With regards to- Yeah, I, I think the nuance is that it, it's, it's, the prior guidance was completion of the enrollment. This is completion of the study. Got it. That's really helpful. Similarly, with, Alzheimer's agitation, we can also expect top-line data first half of next year? Yes. Is that just the trial? Yeah, and then, so and, and similarly, with the Alzheimer's disease agitation, so the, the guidance of trial completion, also incorporates, data readout. Perfect. You know, based on your experience with Digital Centric commercial strategy in partnership with Veeva, is this something that you may also consider down the road for migraine, narcolepsy, or ADHD or even Alzheimer's? Thank you. The rationale behind putting together the platform was so that we could leverage it for our entire pipeline. You know, we're very glad that we made that investment, and we're looking forward to leveraging it for the really vast pipeline that we have of late-stage product candidates. Joon, I can just add one, one piece of commentary there. You know, we are leveraging it for, for Sunosi now as well, so it is, it is across both products that we are leveraging. Thank you. Thank you. Next question today is coming from Jason Gerberry from Bank of America. Your line is now live. Oh, hey, guys. Thanks for taking my question. just wanted to come back to the sales force, announcement. So, I guess, will these new reps just be covering physicians or providers that were not being called on, on prior? I'm just trying to get a sense of, and I think in the past, the, the digital strategy was, was sort of like, I thought, meant to improve breadth and productivity of each prescriber, but there's also maybe a rep that's calling on that provider. So just kind of wondering, like, what, what's changed, you know, in terms of how you'll leverage kind of the, the digital component and where the new rep will specifically be, you know, adding value? Yeah. Thanks, Jason. I'll answer that question kind of in reverse. Our DCC platform, you know, was, you know, part of our DCC platform is how our field is sized, as well as structured. It was intentionally structured so that, you know, we could maintain share of voice, you know, through omni-channel measures as well as, you know, face-to-face, and/or remote engagement with HCPs by reps at the same rate as field forces two times our size. That's why we, you know, the DTC platform is so instrumental in how we reach HCPs. In terms of, you know, the expansion of targets, we originally were calling on about 26,000 HCPs, or prescribers, and we are now taking that up to 44,000 prescribers. I want to make, make, you know, the reason that magnitude is so important in going up to 44,000 is they cover 90% of the branded therapies. Not only do they cover 90% of prescribing a antidepressant, they cover almost, 90% of new branded therapies. They are the ones that are writing. These are the HCPs, the 44,000 are the HCPs that are writing, and finding new patients to put branded therapies on. This is a, you know, a, a very large, you know, expansion of a target list, so it will be current targets and then in addition to, going up to 44,000. If I could just ask a follow-up. The under the older, I guess, approach with, with fewer reps, you would have just, those added 20,000 providers, you would have just, not called on those physicians or just sort of tried to utilize digital means to, to get to those providers? That's right. It doesn't mean they weren't being touched or engaged with. They were just going to get touched or engaged with through digital or media efforts or non-personal promotion efforts. Now we are having reps individually calling them to detail the product. Got it. Got it. Thank you. Thank you. Next question today is coming from David Amsellem from Piper Sandler. Your line is now live. Hey, thanks. Just a couple. First, on SUNOSI. You, you have a P4 filing, no surprise there. I guess the question here is, you know, with all the label expansion opportunities that you're pursuing, how are you thinking about exclusivity runway for the product? I know that there's a lot of patents in the Orange Book, but what have you been assuming, I guess, internally, on what kind of exclusivity runway you think you'll have for the underlying molecule? That- that's number 1. Then just going back to the sales force, as you're thinking about solriamfetol and ADHD, in particular, what's the extent to which you're going to need further headcount, say, in the ped and adolescent psychiatry setting, in the pediatrician settings? I guess the broader question is: How do you think about leveraging the headcount you're going to have in place with respect to solriamfetol? Thanks. Sure. just a lot of questions there. with regards to the label expansion and how we think about the exclusivity runway, even with the, current, issued patents, we have, exclusivity, running out to, at least 20 what? 2042. 2040. Then, in addition to that, you know, we also have recently issued, recently allowed, claims which go out to December 2022, and those cover all of the new indications. I think December 2042. I'm sorry, December 2042. December of 2042. That, so that, that's, that's an even longer exclusivity runway, and so that covers all of the additional indications. With regards to the additional headcount, one of the things that, that, that we like, and I'll, I'll turn it over to Lori, just to maybe provide a little bit more color, but one of the things that, that we do like is the overlap and in the operational leverage with regards to our current neuropsychiatry sales force. You know, ADHD is treated primarily by psychiatrists, so that fits in very nicely with our current sales force and sales force expansion. Yeah, perfect. I don't know that I can add much more other than, you know, it's a bit early to, to, to talk about size and what that looks like, because a lot of factors obviously come into play when you're thinking about what that overlap looks like, at the time. That is, you know, how, you know, entrenched we are with, with Auvelity, what that current sales force efficiency looks like, and whatnot. We definitely like the overlap. Obviously, it's, it's, a very strategic thought from our standpoint in terms of how we, how we structure the field force. We always seek to be efficient and effective, so it will be a consideration, when we, when it comes time to size that field force. Okay. Thank you. Thank you. Next question today is coming from Vikram Purohit from Morgan Stanley. Your line is now live. Hi, good morning. Thanks for taking our questions. Just two for us on Auvelity. First, could you provide some additional color on the profile of patients receiving the drug in terms of prior treatment status and prior line of therapy, and how this has been evolving over the past couple of months? Secondly, could you remind us your latest thinking on ex-US plans for commercialization? I believe in the past you might have mentioned this is something you could evaluate a partnership for. I just wanted to see if that's still your current thinking, and if so, how those internal discussions are going. Thanks. Thanks for the question. I'll answer the last, the second question, and then I'll turn it over to Lori to answer the question on the treatment profile. Ex-US plans, we've always, we've always said that we would look to outlicense the product ex-US, and that, those plans, and that, that strategic direction has not changed. Lori? Yeah, thanks, Vikram. You know, in the very early days of launch, we were, of course, getting that later line patient, just based on, on, you know, mostly due to the unmet need and, and a new, new, new therapy coming to market, especially one with a novel mechanism of action. But as prescribers have gained experience with the product and seen, you know, early success in that patient population, they are starting to move the use up into earlier line. Right now, there is about 10%-12% usage in first-line therapy, which is really encouraging, because that typically means that physicians have seen success in patients that they feel warrants using, you know, the product profile benefits patients as early as first line. The majority that we're seeing right now is, you know, it's roughly around 60% of patients that we're getting have failed either one or two prior therapies. As, you know, as clinicians get more experience with Auvelity, and again, we are only, we are only 2 full quarters into launch. As clinicians get more experience with Auvelity and our access evolves, we do expect it to be prescribed to, you know, to people earlier in the treatment algorithm. Got it. Thank you. Thank you. Next question today is coming from Yatin Suneja from Guggenheim Securities. Your line is now live. Hey, guys, thank you for taking my question. Just real quick ones. With regard to the narcolepsy, can you maybe just talk about hitting on the cognition endpoint there? Like, what do you need to show? Is that even important? Maybe the benefit of showing cataplexy and yeah, just trying to understand what the exact expectation would be. Then quickly, if you can just let us know what the gross-to-net I missed it, if you said it, what the gross-to-net was, and maybe what the inventory is in the channel for Auvelity. Thanks. Thanks for the questions. you know, with regards to AXS-12, you know, cataplexy is, is the primary endpoint of the trial. you know, we are also looking at other endpoints, and specifically, you know, the endpoint that we looked at in the phase 2 CONCERT study. One of those was cognition, as you mentioned. you know, we did demonstrate a reduction or an improvement in the ability to concentrate in, in that trial. That's, that's exploratory, you know, obviously, but it's something that, that we're definitely looking at, because cognition, cognitive difficulty is one of the key symptoms or one of the, one of the symptoms that is experienced by the majority of patients with narcolepsy. Hi, Yatin, it's Nick. As it relates to the gross net for Auvelity, for the quarter, it was in the low to mid-50s. This was an improvement from the high upper 50s in Q1, mostly due to higher proportion of refills of the scripts, which had a more favorable GTN versus new scripts. I think your second question related to inventory, and want to be clear that the performance for Auvelity was not impacted by changes in the inventory level. As we stated previously, normal inventory levels will be and remain around 2 weeks, so no impact specifically as it relates to inventory levels. Okay, just 1 quick one on, on Gross Net. Do you expect that to... I'm just curious, how do you expect it to change over time? You know, once you have sort of full reimbursement, just trying to understand where it should, sort of shake out. Thanks. Thank you. Thanks, Yatin. We expect the GTN for Auvelity to remain in that mid-50 range for the foreseeable future. It's obviously volatile, depending on when payer access comes in, and then that offsets the co-pay reimbursement. For, you know, the foreseeable future, we expect in that mid-50 range for GTN. Thank you. Thank you. Next question is coming from Marc Goodman from Leerink Partners. Your line is now live. Tha nks so much. Take some question. This should be on the line for Marc. Can you provide more color on the duration of effect and persistency for Auvelity? I know you're still in the early stage of launch, but any color would be helpful. Also, can you provide the gross-to-net for Sunosi and inventory changes in the quarter? Thanks. Yeah. Thanks for the question. Could you repeat the second part of the question? We had a little trouble hearing. The second part is, I'm just wondering, the gross-to-net, are inventory changes for Sunosi in the quarter? Thanks. With regards to the duration of effect for Auvelity, what we saw in, in the clinical trials, as you know, our clinical trials were, were six weeks, and the primary endpoint was at six weeks. We showed early onset of action at one week, at two weeks, and basically at every time point, and including at six weeks. Subsequently, in, in very large, as follow-on studies, we looked at the duration of effect. Patients were treated out to at least one year. What we saw was that the improvement either increased or was, was maintained out to at least one year. What we're seeing in, in from, from the actual use of the product in the field, because now we have what? How many patients are on drug now? $40,000. 40,000 patients who've been treated with the product. It's, it's still, still early, but the, the experience and, and the prescription trends support this. We're seeing that the patients are remaining on therapy at the rate that we would have expected. As it relates to Sunosi GTN, it did improve slightly from Q1, typically due to the seasonality impacts. For Q2, we were in the low 50s for GTN, and I, I believe you asked also on inventory. As I, as I stated on the previous question, inventory remains for Sunosi around that 2-week level in general. Got it. It's very helpful. Thank you. Thank you. Next question is coming from Joseph Thome from TD Cowen. Your line is now live. Hi there. Good morning. Thank you for taking my questions. Maybe the first, I think you mentioned a little over 40% of the target, you know, writers have already written a prescription for Auvelity. Maybe great to see the progress, but the remaining that have not written, maybe why are they waiting? Is it really just the lack of, you know, kind of in-person touchpoints, or is there something else that maybe this new sales force can emphasize with the product profile? Then maybe second, is essentially everyone that wants the drug getting the drug, where do we stand with kind of prior authorizations and should that, you know, ease over the next 2 quarters? Thank you. Yeah. Hey, Joseph. Thanks, thanks for the question. I'll comment. You know, when a launch happens, what you typically see is that you have some very early adopters. Those early adopters will, you know, will write, coming straight out the gate, are usually your most informed physicians. Given that Auvelity has a novel mechanism of action, those writers who haven't written it, it certainly isn't due to lack of touch. It is, what it is, is you're now moving into a different physician type. They're typically called fast followers, or they wait and see how the early adopters use the product, and then they start to adopt. That can be achieved through a lot of different means. That's either field force, that's peer-to-peer speaker programs, which we are investing pretty heavily in, through media. They are being touched. Now we're just, we're working through and into that natural phase of a launch where, where you have to educate, you know, the fast followers or the followers, that come after your, your, your very early adopters. Obviously, as we continue to add HCPs, that more than 1,000 new writers, per month, we are seeing, that adoption happen in that, that group as well. In terms of, you know, patients that want the product, we do have a very robust patient support services program, including savings cards, samples, and PA support for, for physicians' offices. We feel very, very confident that, that patients who want the product can, can get the product. Perfect. Then maybe one quick follow-up. I guess, what are you seeing in terms of response rate based on prior line of therapy? Obviously, we saw the open label data in antidepressant-unresponsive patients and TRD patients, you did have that, you know, phase 3 that didn't meet the mark in the TRD patient population. Are you seeing strong responses in TRD patients, or is there an ideal place to focus? Thank you. Yeah. So, you know, we, we look at this pretty closely. In other words, you know, we studied the product in patients with various lines of treatment. So across the entire spectrum, from treatment-naive patients to patients with, with who meet the criteria for TRD. You know, what we, what we saw, and we've announced this in the past, is that the product performs equally well. We're seeing just as strong responses in patients with, with, with, you know, who are naive, who received one line of treatment, and then who received multiple lines of treatment. That's really encouraging. You know, as, as a reminder, in open label data, what we saw, the, the response rate was, you know, into the, the 80, 80% plus range in terms of patients, who were responding. Great. Thank you. Thank you. Next question is coming from Matt Kaplan from Ladenburg Thalmann. Your line is now live. Hi, good morning, guys, and congrats on the strong quarter. Just wanted to focus a little bit more on the SUNOSI solriamfetol expansion into additional indications. Can you give us some more detail in terms of the positive feedback that you received from the FDA with respect to binge eating disorder and shift work disorder? Specifically, how many studies will you need to complete to file for these indications, NDAs, assuming, assuming success? Thanks a lot for the questions, Matt. With regards to the FDA feedback that we received, we received feedback on the entire clinical development plan. In other words, you know, our planned studies to get the products approved. For binge eating disorder, we only need 2 studies, and for shift work, we'll need 1 study. And in terms of endpoints and, for these studies, can you give us more detail on that? Yeah. Typically, you know, we provide the details on the trial design, and the endpoint of the trial once we've started the trial. We, we intend to stay tuned, and we'll be providing more details on both of those studies. But, you know, we do intend to launch from very, in very short order. Binge eating disorder in the fourth quarter and shift work disorder in the first quarter. Great. Then with respect to the initiation that you for the phase 3 study in ADHD, can you give us a little bit more detail in terms of the opportunity that you see Sunosi or solriamfetol filling in that indication? Yeah, so the, it's, it's a, it's a very large patient population, as you know, you know, close to or maybe even, even, rivaling, you know, MDD. Just 17 million patients, you know, who have, who have ADHD. Right now, if you think about the therapies that are available, they fall into, you know, roughly two categories. You know, you have the stimulants, which work, which have, you know, very large effect sizes, but, which have the issues with solubility and, and, and scheduling. Then you have the non-stimulants, which have lower effect sizes. You know, it remains to be seen, obviously, what we'll see with, with solriamfetol. That's why we're conducting the trial. The indications from what we've seen with regards to the, the currently approved indications, so except for daytime sleepiness, is that there's a, there's a very large effect size, and that the drug, you know, does, in fact, translates to ADHD, and we think that it could provide significant benefit to patients and, and fulfill a, a need right now, which is not addressed by the current treatments. Thanks. Thanks, Herriot. Thank you. In the interest of time, we have time for two more questions. Our next question is coming from Graig Suvannavejh from Mizuho Securities. Your line is now live. Okay, thanks for taking my questions. Congrats on the quarter. Just my first one, on the sales force expansion, I was curious. You know, we've seen a flattening of NRX growth on a 4-week rolling basis, so I'm just wondering if the sales force expansion was somewhat related to seeing that, and/or does that sales force expansion, is there a contemplation of perhaps down the line additional sales force adds? Just my second question, just on the pipeline updates. You know, there were a number of, of shifts in the timing, and I'm just trying to get a sense of what's your current confidence in the new timelines that were laid out, or are there potential uncertainties or swing factors that still exist that could trigger, you know, additional delays? Thanks. I'll take the second question, and then Lori will take the first. With regards to the pipeline update, what we're trying to do is make decisions that will generate the most long-term value. We're fortunate to have so many different potential clinical programs which are high value and which are late stage. A lot of this has to do with, one, prioritization, and two, the natural uncertainties that occur with enrolling trials. That's what you're seeing. You know, we're very happy with where we are with the pipeline expansion. We think that that's the right thing to do, and also we're very well resourced to execute and create value. That's where we are, and, you know, I think in the, in the grand scheme of things, you know, any of these shifts is, is within the standard deviation that you, that you might expect with regards to, you know, running any kind of business that, that involves human beings. Lori? Yeah. Hey, thanks, Graig. The, the very short answer is, is no, what we're seeing in terms of, of the trend, has nothing to do with, with the need to expand the sales force. The sales force is purely driven by the fact that we're seeing great adoption and, and, and, and fast uptake by, by physicians. What we're seeing and what we believe we're seeing in terms of the, the flatness, is, is a trend that, that's, that's pretty that we've seen basically since launch, is where we'll go through about four weeks, and then, and then they pop. Right now, I think what we're feeling a little bit is, the seasonality effect. You know, antidepressants typically go through a seasonality effect in the summer, particularly in Q3. They can, you know, sometimes drop as, as much as, as 10%, Q3 versus Q2. That is likely what we're seeing right now. We're, we're very confident in the fact that the field force will add to that, but again, the, the field force should be up and running in Q4. Thanks, Lori. Thank you. Our final question today is coming from Myles Minter from William Blair. Your line is now live. Thanks. I'll just keep it to one. I think you added 6% of commercial covered lives in, in the second quarter here, but you're mentioning that P&T meetings are ongoing, or will occur in the next few months. Do you have line of sight as to what proportion of covered lives in the commercial channel that those meetings would be from plans that represent? Is your ultimate goal still that 90% of covered lives in the commercial channel that are similarly appeared? Myles, could you, could you maybe repeat the last part of that question? We had you faded out a little bit. Yeah, it was just that, is your goal still to aim to achieve about 90% of covered lives in the commercial channel, that, that would be similar to position? Yeah. I'll, I'll, I'll chime in and, and start. Nick might want to add some color around, you know, how we're thinking about it from a gross-to-net standpoint. From, you know, from, from our, our standpoint, our goal has always been, you know, in discussions with payers, to make sure that we ensure that we are capturing the value of the, the, the novelness, the innovation that we bring to the market, as well as the clinical benefit, of Auvelity. Also we want to make sure that we ensure a path, you know, you know, of, to access for patients. There, you know, there are, there are 6.8 million patients who've failed prior therapy, and all of those, all of those patients are typically-... Taking six to eight weeks to see any kind of response with, with another therapy. You know, the delayed onset of action with current therapies, low remission rates, we, we believe Auvelity's clinical profile can really bring, you know, value, to both payers, and to, and to patients. We want to make sure that we're very, very careful, to, to capture that value. Nick, do you want to add anything? Yeah, I, I think you pretty much said it, Lori. Auvelity's, I mean, it's a truly differentiated product, and we just really want to secure meaningful access while maintaining long-term value. Pretty much you said everything. Yeah, the only thing I'll add, I'll add, Myles, is that, you know, the access that we have contracted with, and the coverage that we have, it is very favorable. So, you know, payers are seeing the value of the product, and we want to just make sure we're being very, very cognizant of protecting that long-term value of the product. Yeah. Then, just the last thing that I would add, you know, we're reporting the percentage of covered lives, which is 68%, which is great. It's a great place to be right now. Also, you know, while we can report, you know, real time what the percentage of covered lives is, that does not reflect ongoing progress. So stay tuned. Cool. Thanks. Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to management for any further closing comments. Well, thank you again for taking the time out of your busy schedule to join us for today's update. We are excited to continue building our industry-leading CNS franchise in the back half of 2023. We anticipate a milestone-filled next few months with potential clinical trial reads, new trial initiations, and new submissions. We are committed to ensuring continued success for the launch of Auvelity and commercial growth for Sunosi, and are fast on our way to achieving our goal of potentially having at least five marketed products by 2025. We look forward to updating you on our progress and milestones throughout the rest of the year. Have a great rest of your day. Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.