AXSOME Third Quarter 2026 Financial Results - AXSOME THERAPEUTICS INC

Good morning, and welcome to the Axiom Therapeutics Third Quarter 2026 Earnings Conference Call. My name is Kevin. I'll be your operator for today's call. At this time, all participants are in listening-only mode. Later, we'll conduct a question-and-answer session. Instructions will be given at that time. Please note, this call is being recorded. I will now turn the call over to Ashley Dong, Senior Director of Investor Relations. Ashley, please go ahead. Thank you. Good morning, everyone. Welcome to Axon's third quarter 2026 earnings conference call. Joining me today are Dr. Ariel Tabuto, Chief Executive Officer, Nick Pizzi, Chief Financial Officer, and Ari Maizel, Chief Commercial Officer, who will begin with prepared remarks. Mark Jacobson, our Chief Operating Officer, and Hunter Murdoch, our General Counsel, will also be available for Q&A. Before we begin, I encourage everyone to visit the Investors section of our website to find the press release and presentation for today's call. Please note that today's discussion includes forward-looking statements regarding our financial performance, commercial strategy, and operational plans, including research, development, and regulatory activities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our SEC filings, including our quarterly and annual reports, for a description of these and other risks. You are cautioned not to rely on these forward-looking statements, which are made only as of today, and the company disclaims any obligation to update such statements. And with that, I'll hand it over to Arya. Thank you, Ashley, and good morning, everyone. Axome delivered another robust quarter across our business, driven by continued commercial progress and advancements in our industry-leading neuroscience pipeline. Our commercial portfolio generated $260 million in total revenue in the quarter, representing growth of 52% year-over-year, surpassing a $1 billion annual run rate. We expect sustained momentum for availability driven by strong underlying demand growth in major depressive disorder, and continued acceleration of new patient initiations in Alzheimer's disease agitation. The NOSI continues to show persistent and steady growth. And for Sembravo, our expanded sales team is driving important trial and adoption. Nick will discuss our financials for the quarter, followed by Ari, who will comment on our commercial business. In parallel with the commercial portfolio, our industry-leading neuroscience pipeline comprises 10 development programs, including significant label expansion opportunities for Velody and Synosy, as well as novel product candidates with potential first-in-class and best-in class profiles across areas of high unmet need in brain health. I will review our recent pipeline progress later in the call. Overall, our commercial portfolio is growing, and our industry-leading R&D portfolio is well-positioned to potentially deliver multiple ways of innovation to patients. I will now turn the call over to Nick to review our financials. Thanks, Ariel, and good morning, everyone. Total revenue reached $259.7 million in the third quarter, representing accelerated growth of 52% year-over-year and 19% sequentially. Avelity net product sales were $207.6 million, representing 53% year over year growth and an increase of over 15% sequential growth. Sequential increases over the past two quarters more than doubled the average quarterly increase prior to the label expansion in Alzheimer's disease agitation. The NOSI net product revenue was $48.2 million in the third quarter, representing 47% year-over-year growth. This consisted of $38.5 million in net product sales, $1.2 billion in royalty revenue associated with sales in outlicensed territories, and $8.5 billion in milestone revenue recorded related to cumulative ex-U.S. net revenue. Sembrava net product sales were $3.9 million in the quarter, representing 88% year over year growth. The gross net discount for Sembravo was in the mid 80% range. Gross net discounts for Avelity improved to the mid to high 40% range, Synosy also improved into the high 40 percent range for the third quarter. We anticipate gross net discounts for both products to increase slightly in Q4 due to typical seasonality. Turning to expenses, cost of revenue in the quarter was $17.8 million compared to $11.9 million in the third quarter of 2025. Gross margin remained healthy in that low to mid 90% range. Research and development expenses were $50.6 million compared to 40.2 million in a third quarter 2025, primarily reflecting costs associated with our ongoing late-stage clinical programs for Sol-Re-Amphitol, AXS-14, and AXSO-5. Selling general and administrative expenses were $203.1 million compared with $150.2 million for the third quarter of 2025. The increase versus prior year was primarily driven by commercialization activities for Avelody and Sembrava. SG&A was essentially flat quarter over quarter as the bulk of the original field force expansion is now reflected in our run rate finally net loss for the quarter decreased to 12.9 million dollars or 25 cents per share compared with 47.2 million dollars, or 94 cents per, share in the third quarter of 2025. this improvement underscores the continued operating leverage in our business as revenue growth increasingly translates to the bottom line the net loss of 12.9 million for the quarter included 26.4 million dollars in stock-based compensation expense turning to the balance sheet we ended the quarter with approximately 314 million dollars in cash and cash equivalents this compares to 323 million dollars at year-end 2025. we continue to expect that our current cash balance will be sufficient to fund anticipated operations through cash flow positivity. And with that, I'd like to turn the call over to Ari for a commercial update. Thanks, Nick, and good morning, everyone. I'm pleased to share the progress across our portfolio of three approved medicines, particularly the growing momentum behind Ovality. Overall, total prescriptions reached approximately 302,000 in the third quarter, an increase of 40% year-over-year and 14% sequentially, significantly outpacing the antidepressant market, which grew 3% and 2% in the same time periods, respectively. In addition, Q3 marked the second consecutive quarter of double-digit demand growth for both new-to-brand prescriptions and total prescriptions across all age groups, with acceleration across both indications. In the 65 years and older segment, which reflects primarily the Alzheimer's agitation indication, new-to-brand prescriptions grew 211 percent year-over-year and 99 percent sequentially. New-to brand prescriptions reflect new patient starts and are a key leading indicator of total prescription growth. In the quarter, total prescriptions in the 65 years and older segment grew 101 percent year over year and 43 percent sequentially in the less than 65 year old segment, which reflects primarily the major depressive disorder indication, new-to-brand prescriptions grew 27% year-over-year and 10% sequentially. Total prescriptions in the less-than-65-year-old segment grew 33% year over year and 10 percent sequentially in the quarter. We expect momentum in new-To-Brand prescriptions to continue, contributing to ongoing and increasing total prescription growth in the coming quarters. Overall, alveolity growth is being driven by both increased prescribing frequency among existing riders and continued acceleration in new rider activation. In the third quarter, we activated approximately 8,200 new alveoli prescribers, representing 49% growth versus the prior quarter and bringing the total number of unique alveoloid prescriber since launch to approximately 77,000. Our expanded availability sales team is driving broader adoption across prescriber segments, particularly primary care, which remains the fastest growing segment for availability in terms of both prescribers and prescription volume across both indications. Primary care represented nearly 40% of prescrivers and 25% of total prescriptions in the quarter. We expect primary care adoption to continue to grow in MDD and Alzheimer's agitation and remain an important driver of long-term growth for the overall brand. The breadth of Ovality demand growth across indications, age cohorts, prescriber segments, and settings of care is a positive signal of the impact Ovality is having on patients and prescribers throughout the U.S. We are very pleased with feedback of the clinical responses observed in real-world settings, which include rapid and sustained symptom relief, positive impact on quality of life, a manageable safety and tolerability profile for both MDD and Alzheimer's disease agitation patients. Alveolity coverage remains at approximately 89% of total lives across channels, including 82% of commercial lives and approximately 100% of lives in the government channel. Our market access team is working closely with payers in both the commercial and government channels, and we expect patient access for alveolty in both MDP and Alzheimer agitation markets to continue to expand and evolve. Based on Alvelity's initial uptake in Alzheimer's disease agitation and sustained momentum in MDD, Alvelety is well-positioned to generate at least $8 billion in annual revenue at peak. Turning now to Sembravo, which grew 382% versus Q3 2025 and 7% sequentially to more than 25,000 total prescriptions, outperforming the migraine market, which grew 6% versus Q3 2025 and 4% sequentially. New prescriber growth from the neurology and primary care segments underscores the growing place in treatment for Simbravo for patients who experience inadequate response to prior acute migraine treatment options. Prescriber and patient feedback consistently highlights Simbrabo's rapid impact on migraine symptoms, the same response out to 24 and 48 hours, and predictability of response across multiple migraine attacks. Overall payer coverage remains at approximately 57 percent of lives covered across channels, including approximately 56 percent of commercial lives and 57 percent of government lives. We expect coverage for Sembravo to expand and evolve moving forward. Synocy delivered another quarter of growth with more than 64,400 total prescriptions written during the quarter, representing 15% year-over-year growth and 6% sequential growth compared to the weight-promoting agent market, which was flat compared to Q3 2025 and experienced a 2% increase versus the prior quarter. Nearly 17,650 clinicians have now prescribed Synocy since launch, and we continue to maintain broad payer coverage of approximately 82 percent of lives covered across all channels with an established commercial infrastructure robust growth for availability in mdb and alzheimer's disease education continued progress for sembravo and migraine and durable growth for cynosi and eds associated with narcolepsy and obstructive sleep apnea axon is poised to drive demand across our novel medicines and positively impact patients throughout the united states for years to come. I will now turn the call back to Ariel. Thank you, Ari. Alongside the growth of our commercial portfolio, our industry-leading neuroscience pipeline continues to advance toward a number of important clinical and regulatory milestones. I Will now review our recent pipeline progress and key upcoming clinical and regulatory milestones, starting with our ongoing clinical programs in psychiatry. With availability now approved for depression and Alzheimer's disease agitation, we have initiated development of AXS05 for the treatment of smoking cessation, a third potential indication. In August, we initiated the summit phase three trial of A X S O five for the Treatment of Smoking Cessation. This is a three orange study with a primary endpoint of smoking abstinence at 12 weeks. We anticipate top-line results from this study in the second half of 2027. We also continue to advance our label expansion clinical programs for psori-amphetol across four indications, including ADHD, binge eating disorder, shift work disorder, and major depressive disorder. In ADHD, our recently launched Focus 2 and Focus 3 Phase 3 trials of Solvium Vital in children and adolescents are enrolling, with top-line results from both studies anticipated in the second half of 2027. These two studies, if positive, together with a previously completed positive focus phase three trial of solar re-infantile in adults, would form the basis of an NDA filing for solar reinfantil in the treatment of ADHD. In binge eating disorder, targeted enrollment has been reached in our ENGAGE phase three trial, and we are on track for top-line results in the first quarter of 2027. Top-line results for our sustained Phase III trial of solar re-infantile in shift work disorder are anticipated in the second half of 2027. An enrollment completion for our clarity Phase III trail evaluating solar re‑infantil in major depressive disorder with symptoms of excessive daytime sleepiness is anticipated in the first half of 2020. Rounding out our psychiatry programs is AXS20, our novel selective PDE10A inhibitor. We have made meaningful progress with our clinical trial preparations and anticipate initiating a pivotal phase three trial in schizophrenia in the first half of 2027. Turning to our neurology clinical programs, our NDA for AXs12 for the treatment of cataplexy in narcolepsy is currently under review by the FDA, with a BEDUVA target action date of May 1, 2027. If approved, AXS-12 would provide a differentiated new treatment option for patients with cataplexy and further strengthen our growing sleep franchise. For AX-14, our forward phase 3 trial in fibromyalgia is advancing, and we anticipate completion of enrollment in the third quarter of 2027. If positive, the forward study, along with the previously completed positive phase two and phase three trials, would support an NDE filing for AXS-14 for the management of fibromyalgia. Finally, we are advancing AX-17, our novel GABA-A alpha-2, 3 subtype selective positive allosteric modulator. We plan to initiate clinical trials for this molecule in epilepsy in the first half of 2027. Overall, our extensive late-stage pipeline continues to advance, positioning us to continue to deliver innovation for patients and value for shareholders. I will now turn the call back to Ashley. Thanks, Ariel. This concludes our prepared remarks and we'll now begin the Q&A session. To allow enough time for as many questions as possible, we kindly ask that you limit yourself to one question. Kevin, please open the line. Sir, we will now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. And as a reminder, we ask you please ask one question, then return to the you. Our first question today is coming from Kripa Debarakandu from Truist Securities. Your line is now live. Hey, guys. Thank you so much for taking my question. On Ovelity, I was wondering if you can talk a little bit about the samples to paid conversion. Now that you have a full quarter of the agitation launch, how are the, you know, the earliest patient cohorts progressing from samples to paid PACs, you know, maintenance, prescriptions, et cetera, and is this in line with your internal expectations? Thank you so much. Yeah, thanks for the question. So, we're sampling at a similar rate to what was observed during the MDD launch, and demand for ADA samples is strong. Although we have visibility into the samples that are provided to HCPs, we do not have precise data on whether those samples are dispensed directly to patients. Now, that said, we are seeing positive NBRX growth among sampled HCPs and expect that trend to continue based on our expectations. Thank you. Our next question is coming from Rudy Lee from Wolf Research. Your line is now live. Thanks for taking my question. It's just a quick follow-up to Ami's question. So I think most inventors still use Rexaudi as a bar for ADA commercial uptake, which was launched like three years ago. Can you help us understand the key differences now in market dynamics and the marketing strategy versus Rexaudis? Any comment would be helpful. Thanks. Sure. Yeah, as a reminder, we don't typically comment on products that aren't our own. As you know, Avelity results are different products with different mechanisms, and one would expect different launch dynamics, which is what we're seeing. As it relates to the market, there's still significant education required in this marketplace. In some ways, this is still a new and developing market with little precedent. And so from our perspective, there is clear focus on educating on the clinical profile for availability but there's still a significant opportunity to educate on agitation symptoms identifying and diagnosing those symptoms as early as possible for patients and treating those symptoms in order to support patients and care partners and improve quality of life overall so from our perspective this is still a relatively new and developing market but we're very encouraged by what we've seen thus far and see plenty of opportunity for ongoing education Thank you. Next question is coming from Ash Verma from UBS. Your line is now live. Hey, guys. Thanks for taking my question. So for ADA, I know you talked about that the launch has met your internal expectation, but it seems that it hasn't met investors' expectation with the stock down 40% to 45% since the launch had started. And 3Q, like you had the sell side, And you have come above that. But just when you think about the 4Q consensus and 2027 consensus, do you think that this is at the right place or do you thing that it needs to come down a little bit? Thanks. Timothy Stenzelman, Sure. Hey, Ash. So yeah, so Q3 we came in at 207.6 and we don't give specific guidance on for Q4 or for 2027, but we did see robust growth from Q3 to Q2, and we expect to see continued growth in availability, specifically with the refills that we would see from the NBRX growth that we saw. Twenty-six percent growth sequentially Q2 versus Q1, and then 21 percent Q3 and Q2. So we would expect that to turn those NBRxs turning into TRXs. Thank you. The next question today is coming from Leonid Timishev from RBC Capital Markets. Your line is now live. Hey, guys. Thanks for taking my question. I just want to ask on real-world payer dynamics. Obviously, you guys have good coverage in the channels, but I guess what are you seeing on the ground with respect to how patients are managing co-pays, how they're converting from if they're having any trouble converting from free to paid? Just anything you can comment there. Thanks. Yeah. Yeah, thanks Leo. I assume you're referring to Alzheimer's education patients specifically and, you know, with Medicare, we've worked really hard to ensure access and coverage for patients. Obviously, every patient is different based on their coverage based on, uh, their, their income. And what we've seen is is good dispensing dispense rates for patients that are prescribed. the product, which suggests that not only are they getting coverage, but the affordability has been manageable for them. Of course, that's not a universal truth for all patients, and we work really hard to provide education and resources in order to support patients that may have challenges with affordability. But overall, we've been really pleased with how patients have been able to fill prescriptions once written. Thank you. Next question is coming from Mark Goodman from Learing Partners. Your line is now live. Yes. Can you go back to the gross-to-net comment that you made and talk about the dynamics that impacted it in the third quarter, how you're expecting fourth quarter and 2027? Seems like it came down a little more than we expected in the quarter. Thanks. Sure, Mark. uh yeah so the gtn for the quarter uh improved to the mid to high 40s in q3 um we were around 50 in q2 so we would anticipate that that gtm will be shared it will slightly increase in q4 and the only reason for that is not to get into the accounting but you need to accrue for the gt n for the scripts that will adjudicate in q1 as always we typically have two weeks of inventory on hand at the end of any given quarter so those two weeks we just need to accrue and incur that expense in q4 for scripts that get adjudicated in q1 uh for 2027 i think you asked mark you know how would we anticipate gtn to look for ability uh similar similar to 2026 uh low 50s is where we were in q 1 approximately 50 percent in q2 mid high 40s as we shared in q3 and a slight tick up from that Q3 number this quarter for Q4. Thank you. Next question today is coming from Jason Greberry from Bank of America. Your line is now live. Hey, guys. Thanks for taking my question. I have a non-availability ADA question. So just on the Phase 3 start for AXS20 in schizophrenia, I'm curious how you guys are thinking about approaching this trial in a setting where we're seeing a trend of rising placebo rates, placebo responses in schizophrenia trials? Anything that unique that you guys think you can employ or deploy in a phase three trial design to help mitigate that just general risk in endeavoring in a schizophrenia phase three? Thanks. DR. Thanks for the question. So the placebo response is something that we think about quite a lot as we design all of our studies we had experience dealing with the high placebo response rate in other indications for example mdd is notorious for having a high placebo-response rate um adhd same thing and even when we conducted parallel group trials we've been able to implement a lot of bells and whistles so So these are small changes to our clinical trial protocols, some of which are proprietary, which we've honed over the past several years, and we fully intend to use those in any study that we would design in psychiatry. Thank you. Our next question is coming from David M. Sullivan from Piper Sandler. Your line is now live. Hey, thanks. So, I wanted to drill down on the long-term care panel and how you're thinking about that opportunity in ADA as we move through 27. What's your dialogue been like with institutions? And just remind us how you are thinking about the opportunity in LTCs relative to the broader ADA opportunity. Thank you. Yeah, thanks, David. LTC as a channel is performing well thus far with growth rates that are similar to what we reported for patients 65 and older. The response to Alveolity's clinical profile has been very positive, and there's a clear value proposition for LTC facilities to prescribe Alveoli compared to other treatment options. As you know, LTC sales involve multiple nursing home stakeholders, LDC pharmacy chains, provider groups that are contracted to care for residents, and so it is distinct from community settings where the HCP is the primary target. Although the sales cycle can be a little longer in LTC facilities, we are pleased with early progress and believe it'll be an important source of business for Avelity moving forward. Thank you. Our next question today is coming from Sean Martin from Morgan Stanley. your line is now live. Good morning, team. Hope everyone's well. In the under 65 TRX with Ovelity, how much of that growth reflects underlying demand versus the expanded sales force? And when should the productivity benefits from that expansion mature? Thank you. Yeah, thanks so much. As it relates to both the approval of ADA and the sales force expansion, we've seen significant growth, which we expect to continue as the sales force continues to become more effective and more productive. And this expectation is really based on what we've seen as it relates to new patient initiations. So as you mentioned, 65 and younger, we saw significant growth in NBRX, which is the metric we use to track MDD. NBRx for patients under 65 grew 27%. When you think about where we were before the Salesforce expansion, for patients 65 and younger, monthly TRX were approximately 67,000. And as of September 2026, TRX was approximately 88,200, representing approximately 32% growth. So we're very pleased with the early impact of the Salesforce Expansion, and we expect as that team becomes more productive and more effective, growth trends will continue. Thank you. Our next question today is coming from Malcolm Hoffman from BMO Capital Markets. Your line is now live. Hi, guys. Thanks for taking my question and congrats on the quarter. Tourette's Syndrome was noted as an opportunity for AXS20 previously, but seems to be removed from the pipeline slide today. Does that reflect a formal development decision or just prioritization of schizophrenia? Thanks. Hey, thanks for the question. There's no change. That's still of interest. You know, that's just further back in the pipeline, so we wanted to highlight the later stage programs. But there's no changed to our plans there. Thank you. Next question is coming from Andrew Sy from Jeffries. Your line is now live. Morning, thanks, for the update. The MBRX data for the 65 plus age group looks quite healthy, I think 99% quarter to quarter. So, when do you think the NBRX inflection will meaningfully cash up to TRX exactly? Are we talking days, weeks away, or is this kind of a months to quarters away kind of thing? Thank you. Yeah, thanks for the question. You know, as it relates to the under 65, you know, we've been very pleased, you know, the NDRX, as you mentioned, sorry, for 65 and older, grew 211% year over year. When you look at TRX prescription volume for the ADA indication, prior to launch, monthly TRX for patients 65 and older were approximately 8,300. And as of September 2026, TRX were approximately 14,800, representing 78% growth since the approval. So we're pleased. We expect the upward trajectory to continue, and our focus on new patient initiations will also continue, which will support ongoing and persistent demand growth. Thank you. Our next question is coming from Joseph Tone from TD Cal, and your line is now live. Hi there. Good morning, and thank you for taking my question. Maybe just talking about where these patients are coming from in terms of prior treatment. Are these patients in the ADA segment, are they treatment-naive? Are they coming from prior Rixalti? Are they come from prior SSNRI off-label use? Maybe where are you finding maybe the most interest in terms of the specific patient population? And I guess if you're interacting with a physician and maybe they're not ready to use Ability for their ADA patient yet, maybe what's the main reason and how can you address that? Thank you. Yeah, thanks, Joe. when we look at prior treatment experience, it really does cover a broad spectrum of prior treatments, ranging from generic antidepressants, generic antipsychotics, to branded antipsychotic. You know, the feedback that we've heard is that patients who are both naive to treatment as well as treatment experience have been prioritized for early trial from the providers who have prescribed in the early days of launch. Regarding barriers to adoption, I would say there's not much in the way of barriers outside of just gaining comfort with the clinical profile and identifying the first patient to try it with. So there hasn't been anything in particular that has stood out to us. But as you know, with any new product launch, raising education and awareness is really important, and some clinicians are more comfortable writing very early into a launch where others need some additional education before trying for the first time. Thank you. Next question today is coming from Yathin Suneja from Guggenheim Securities Alliance. Hey, guys. Thank you for taking my question. I wanted to maybe ask a question on the narcolepsy review. anything you are able to share, maybe also put in perspective how you're thinking about the market, the segment of the market where the competitive dynamic are shifting on the narcolepsy space. Thank you so much. Hey, this is Mark. I'll take the first part of that. So with respect to the review, and review is progressing as expected. There are just under six months to go. Nothing out of the ordinary from where we are at this stage. A reminder, the PDUFA date is May 1st, so pre-launch activities are underway. Just one other thing, a reminder, FDA doesn't currently plan to hold an adcom, and I'll turn it over to Ari for the second part of the question. Yeah, we're really pleased with the AHS-12 clinical profile that's been demonstrated across our clinical trials. And given the heterogeneity in the narcolepsy market and the inconsistent clinical response that patients have with existing medications, we believe the more treatment options, the better. Thank you. Next question is coming from Ben Burnett from WellSparkle. Your line is now live. Hey, great. Thank you, just on ability, I wanted to touch back again on the adoption ramp that you're seeing in AD agitation. Are there any natural bottlenecks within the system that you just have to contend with given this is a new indication for ability? So, like anything in terms of distribution or updating hospital EMR systems, just is there anything that needs to naturally happen that might maybe open up this ADA agitation launch a bit more? Yeah, thanks, Ben, for the question. In terms of the ramp, you know, we shared on the prepared remarks that, you know, NBRX in 65 and older grew 211% year over year, and TRX have grown about 78% since since the approval. So, you know, we're pleased with the progress we've made in terms of adoption. Related to the bottlenecks, there are no major bottlenecks that we can see. I think in the early days, certainly EMR systems and e-prescribing systems need to be updated with new dosage and administration forms and things of that nature, but there's nothing standing in the way of of prescribing at this point in time. Thank you. Our next question is coming from Brian Scorney from Beard. Your line is now live. Hey, good morning. Thank you for taking the question. Back on a valid, just trying to get a feel for any prescription abandonment you're seeing. I would assume the vast majority of Medicare patients would have already covered their annual out-of-pocket cap. Is that the case? And are you seeing any active formulary management in the Advantage plans? and just wondering, are you seeing any disruption due to all the Advantage plans that have been shut down, or do you anticipate that being kind of a headwind or tailwind going into next year? Thanks. Yeah, thanks for the question. As it relates to abandonment, generally speaking, abandonment in Medicare is generally higher than what is observed in commercial, and certainly that's been our observation if you compare ADA and MDD. However, there's nothing outside of the ordinary as it relates to abandonment, and there's really been no disruption regarding Medicare Advantage plans. We've worked really hard to secure access with no PA requirements, and the feedback we've received is that patients are getting access and filling prescriptions at a very high rate. So, overall, we feel very good about the Medicare dynamics for agitation. Thank you. Next question is coming from Ami Fadiab from Neiman Company. Your line is now live. Hi. Good morning. Thanks for taking my question. Just with regards to the upcoming data readout I'm sorry, Amphitol, in binge eating disorder. From a commercial standpoint, what type of profile would be competitive in terms of the efficacy and the safety profile that you're looking to see from the results? Thank you. Thanks for the question. This will be the first study that we've conducted in binge-eating disorder. So what we're looking to see, first of all, is a separation from placebo for the two doses that we're testing. The other thing that we are looking for is a safety profile which is consistent with the safety profile that has been established for slovenia infantil. And so we like the fact that this is a drug which is very efficacious in the current indications. and which is also incredibly well-tolerated. So, we think that given that there's only one other product that is currently approved in the marketplace, which is highly scheduled, and which also has certain side effect drawbacks, should we be able to deliver another product, which not only is efficacious, but which we know is well- tolerated, then we think that the marketplace would welcome that, and it would be used to giving an advance of patience. Thank you. Next question is coming from David Holm from Deutsche Bank. Your line is now live. Hi, Eric. Good morning. Thanks for taking my question. I wanted to ask about, you know, we have obviously visibility to third-party vendor script trends going through October for several weeks. From your end, how, to the extent you have data, How are those tracking versus your expectations? And should we be thinking about any impact of seasonality or other things in Q4? For Abelody, that is, thank you. Yeah, thanks for the question, David. You know, Q4 is shaping up based on our expectations, continued growth in both indications. Obviously we still have two months left in the quarter. Our team is focused on driving NBRX growth across both indications and continued penetration of primary care settings. So I think it's premature to suggest what Q4, and obviously we don't guide on quarters moving forward, but we are feeling very good about the overall business trends and look forward to closing out the year on a high note. Thank you. Next question is coming from Greg Zivanoves from the Zuhu Yule Line. Is that live? Hey, good morning, and thanks for taking my question. Just wanted to stay on the prescription data. Could you comment just on capture rates between Symphony and IQV? I think by our look, maybe IQV capture rates stayed relatively consistent, but maybe ticked up higher for Bloomberg Symphony data. Maybe you can comment on what you saw for this last quarter. Thanks. Perfect. Yeah, capture rate this quarter did appear to fluctuate a bit, potentially due to the addition of new pharmacies with the launch in ADA. Specifically, IQVIA seems to be impacted the most. That decreased to somewhere around 90%. Additionally, we're made aware that a pharmacy chain stopped reporting scripts in October to one of the data providers, which may also be impacting the weekly TRXs or NBRX numbers. Obviously, it's a third-party provider. We don't have any other additional detail around that, but just we are, we were made aware of that. Thank you. Next question is coming from Matthew Herschenhorn from Oppenheimer, your line is now live. Hey, guys, thank you for taking the question. Congrats on all the progress. First, we are wondering about the lipodectin schizophrenia just as you initiate the phase three early next year, how you're envisioning beyond that potential real-world advantages just based on the mechanism compared to the profiles of some of the other novel agents out there, like Cabenfi and Keplida. Basically, what unmet needs do you still see in the market currently that could potentially address just thinking through the mechanism? And if you could, please comment on your current appetite and capacity for additional BD deals. That would be great. Thank you. So, what we like about this novel PDE-10A inhibitor is that already in a control study there was a very strong efficacy signal. And also, given the mechanism of action, one of the benefits which was seen in that study and also in animal studies is the lack of metabolic side effects. So that's just a highlight of the favorable safety profile of this product candidate. So if you can maintain or generate greater efficacy than is seen with the current agents, as well as getting rid of some of the very serious side effects that are seen with atypical antipsychotics, then we think that that would be a very meaningful advance to patients with schizophrenia. Now, in addition to that, we believe that this mechanism of action may have relevance for other indications. So we've mentioned Tourette's Syndrome, but there are other indications, too, that we are contemplating evaluating with this novel mechanism of actions. Thank you. As it relates to – sure, I'll just – I think it was the second question that got in there on bd as it relates to additional bd deals uh you know we did do this this two two transactions over the last couple quarters specifically around schizophrenia and epilepsy access 17 and axs 20 and those deals from a financial perspective made sense we feel like we can tuck them in develop them in our pipeline but importantly does not impact our investment strategy in driving growth for availability Thank you, next question is coming from Miles Minter from William Blair, your line is now live. Hey, thanks for taking the questions. Just on psoriapital for binge eating disorder in the ENGAGE study, you mentioned that target enrollment had been achieved but that enrollment hadn't necessarily been complete, is that just sort of like a 10% buffer above the 450 patients that you expect or are you changing enrollment somehow and then just anything on potential dose response between the 150 and the 300 mcdose first placebo don't think you saw that in ADHD but if there's a possibility of seeing it here in binge eating disorder thanks very much great so enrollment is basically completed and we are on track to report top line results in the first half of the first quarter so we're we're done and you know that the language that we put in there is, as you know, when you're enrolling in clinical trials, even when you do complete enrollment, there might be patients who are still in screening, and it is typical to, it is customary to allow those patients to percolate through the system, but we completed enrollment, and so we're very confident in reporting top-line results shortly in the first quarter. Thank you. Our next question today is coming from Madison Alsati from B Riley Securities. Your line is now live. Hi. Thanks for taking our question. I have one on AXS20. Is this something you think would have efficacy on top of a D2 antagonist or even a muscarinic compound without increasing the movement disorder risk? Or is this something that the team envisions as ultimately being a potential first-line therapy? Thank you. DR. So, we're developing it as a first- line therapy. Studies that have been conducted have been with the XS20 or the LIFT Act as a single agent. And so, we would be replicating that study in a Phase III trial. DR. Thank you, our next question is, can you Thank you very much for taking our questions. With respect to product revenue, I was just wondering if you could provide us with any additional color on how you expect covered lives percentages to evolve for Simbravo over the course of the remainder of this year and into early 2027, and when you anticipate the vast majority of covered lives to ultimately have access to that product. And then with respect to AXS-14 and fibromyalgia, can you just give us a sense of the timing of release of top-line data from the Phase III program, assuming that you complete enrollment in line with your previously stated timeline guidance, as well as what the implications of this might be for the potential timing of an NDA submission? Thank you. DR. Yeah, thanks. I'll start with the question on Sembravo access. Obviously, we're engaged with payers in both the government and commercial channels. As you know, it's very difficult to predict timing of any new access contract, but we have been encouraged by the ongoing dialogue and continue to focus on expanding and evolving Sembravo Access. So, can't give you a specific increase in covered lives moving forward, but we are continuing to engage on Sembravo, which has really established itself as a meaningful treatment option, particularly for patients who have had an inadequate response to prior acute migraine treatment. So, we'll share additional updates as we have them. Great. So to the second part of your question regarding AXS-17, the timeline for reporting data data is a little hard to predict because this is a randomized, raw study. So we've given guidance as to enrollment. So once the study enrolls, then the way that randomized and raw studies work is you wait for the pre-specified number of relapses. Now as it relates to timing of filing of an NDA, we would be ready to file an NDE very shortly after we finish the study. So, typically, this is roughly six months. In this case, it could be less than that. And the reason for that is that this would be a resubmission. As a reminder, we have completed already two positive studies, a Phase 2 trial and a Phase 3 trial. So, within six months of reporting top line results for the currently enrolling study, we would be ready to file an NDA. Thank you. Next question is coming from Pete Strabopoulos from Cancer for Children. Your line is now live. Hi. This is Samantha on the line for Pete. Congrats on the quarter, and thanks so much for taking our question. AXS-12 or riboxetine, with the first approval of an orexin-2 receptor agonist, how are you thinking about the underlying commercial opportunity for riboxetein in the narcolepsy market? And more specifically, have you had discussions with payers around the profile and possible pricing? And how are we thinking about commercialization efforts given this new entrant but sizable opportunity, which I believe you estimate to be about $185,000 in the U.S.? Thanks so much. Yeah, thanks for the question. As I shared earlier, we're really pleased with the profile of AXS-12 that we saw in the clinical trials, and also that patients in this market have really inconsistent response to existing medication. So we believe that AX-12 as a treatment option will be well received and adopted. Our engagement with payers thus far has been very positive. understand that cataplexy is a debilitating symptom, often unresolved for many narcolepsy patients, and we expect there to be a place in treatment for AXS-12. We don't typically comment on pricing or access dynamics prior to launch, but we feel good about the nature of our dialogue with payers thus far and look forward to a potential approval of AX-12 Thank you. We've reached the end of our question-and-answer session. I'd like to turn the floor back over for any further or closing comments. Thank you, Axiom continues to make important progress across the business. Our commercial portfolio is growing at scale, with substantial further growth across both major depressive disorder and Alzheimer's disease agitation. Our pipeline is also advancing toward key clinical and regulatory milestones that further expand the long-term potential of our singular CNS portfolio. We are executing against our strategic priorities. The fundamentals of our business only continue to improve, and we are well-positioned to close the year strong and enter 2027 with significant momentum. Thanks all for joining us, and have a great day. Thank you. That does conclude today's teleconference. We may disconnect your line at this time and have a wonderful day. We thank you for your participation today.