Good morning, and welcome to the Axsome 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 listen-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 Axsome's Third Quarter 2026 Earnings Conference Call. Joining me today are Dr. Herriot Tabuteau, Chief Executive Officer, Nick Pizzie, Chief Financial Officer, and Ari Maizel, Chief Commercial Officer, who will begin with prepared remarks. Mark Jacobson, our Chief Operating Officer, and Hunter Murdock, 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. With that, I'll hand it over to Herriot.
Thank you, Ashley, and good morning, everyone. Axsome 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 AUVELITY, driven by strong underlying demand growth in major depressive disorder and continued acceleration of new patient initiations in Alzheimer's disease agitation. SUNOSI continues to show persistent and steady growth. For SYMBRAVO, 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 AUVELITY and SUNOSI, 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 waves of innovation to patients. I will now turn the call over to Nick to review our financials.
Thanks, Herriot, 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. AUVELITY 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. SUNOSI 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 million in royalty revenue associated with sales in out-licensed territories, and $8.5 million in milestone revenue recorded related to cumulative ex-U.S. net revenue. SYMBRAVO net product sales were $3.9 million in the quarter, representing 88% year-over-year growth. The gross-to-net discount for SYMBRAVO was in the mid-80% range.
Gross-to-net discounts for AUVELITY improved to the mid-to-high 40% range. SUNOSI also improved into the high 40% range for the third quarter. We anticipate gross-to-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 the third quarter of 2025, primarily reflecting costs associated with our ongoing late-stage clinical programs for solriamfetol, AXS-14, and AXS-05. 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 AUVELITY and SYMBRAVO.
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, or $0.25 per share, compared with $47.2 million, or $0.94 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 in stock-based compensation expense. Turning to the balance sheet, we ended the quarter with approximately $314 million in cash and cash equivalents. This compares to $323 million at year-end 2025. We continue to expect that our current cash balance will be sufficient to fund anticipated operations through cash flow positivity. With that, I would like to turn the call over to Ari for a commercial update.
Thanks, Nick, and good morning, everyone. I am pleased to share the progress across our portfolio of three approved medicines, particularly the growing momentum behind AUVELITY. 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% year-over-year and 99% 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% year-over-year and 43% 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% 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, AUVELITY growth is being driven by both increased prescribing frequency among existing writers and continued acceleration in new writer activation. In the third quarter, we activated approximately 8,200 new AUVELITY prescribers, representing 49% growth versus the prior quarter and bringing the total number of unique AUVELITY prescribers since launch to approximately 77,000. Our expanded AUVELITY sales team is driving broader adoption across prescriber segments, particularly primary care, which remains the fastest-growing segment for AUVELITY in terms of both prescribers and prescription volume across both indications.
Primary care represented nearly 40% of prescribers 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 AUVELITY demand growth across indications, age cohorts, prescriber segments, and settings of care is a positive signal of the impact AUVELITY 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, and a manageable safety and tolerability profile for both MDD and Alzheimer's disease agitation patients. AUVELITY 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 AUVELITY in both the MDD and Alzheimer's agitation markets to continue to expand and evolve. Based on AUVELITY's initial uptake in Alzheimer's disease agitation and sustained momentum in MDD, AUVELITY is well-positioned to generate at least $8 billion in annual revenue at peak. Turning now to SYMBRAVO, 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 SYMBRAVO for patients who experience inadequate response to prior acute migraine treatment options.
Prescriber and patient feedback consistently highlights SYMBRAVO's rapid impact on migraine symptoms, sustained response out to 24 and 48 hours, and predictability of response across multiple migraine attacks. Overall payer coverage remains at approximately 57% of lives covered across channels, including approximately 56% of commercial lives and 57% of government lives. We expect coverage for SYMBRAVO to expand and evolve moving forward. SUNOSI 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 wake-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 SUNOSI since launch, and we continue to maintain broad payer coverage of approximately 82% of lives covered across all channels. With an established commercial infrastructure, robust growth for AUVELITY in MDD and Alzheimer's disease agitation, continued progress for SYMBRAVO in migraine, and durable growth for SUNOSI in EDS associated with narcolepsy and obstructive sleep apnea, Axsome is poised to drive demand across our novel medicines and positively impact patients throughout the U.S. for years to come. I will now turn the call back to Herriot.
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 AUVELITY now approved for depression and Alzheimer's disease agitation, we have initiated development of AXS-05 for the treatment of smoking cessation, a third potential indication. In August, we initiated the SUMMIT phase III trial of AXS-05 for the treatment of smoking cessation. This is a three-arm 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 solriamfetol 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 III trials of solriamfetol 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 the previously completed positive FOCUS phase III trial of solriamfetol in adults, would form the basis of an NDA filing for solriamfetol in the treatment of ADHD. In binge eating disorder, target enrollment has been reached in our ENGAGE phase III trial, and we are on track for top-line results in the first quarter of 2027. Top-line results for our SUSTAIN phase III trial of solriamfetol in shift work disorder are anticipated in the second half of 2027. Enrollment completion for our CLARITY phase III trial evaluating solriamfetol in major depressive disorder with symptoms of excessive daytime sleepiness is anticipated in the first half of 2027.
Rounding out our psychiatry programs is AXS-20, our novel selective PDE10A inhibitor. We have made meaningful progress with our clinical trial preparations and anticipate initiating a pivotal phase III trial in schizophrenia in the first half of 2027. Turning to our neurology clinical programs, our NDA for AXS-12 for the treatment of cataplexy in narcolepsy is currently under review by the FDA, with a PDUFA target action date of May 1st, 2027. If approved, AXS-12 would provide a differentiated new treatment option for patients with cataplexy and further strengthen our growing sleep franchise.
For AXS-14, our FORWARD phase III 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 II and phase III trials, would support an NDA filing for AXS-14 for the management of fibromyalgia. Finally, we are advancing AXS-17, our novel GABA-A alpha2/3 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, Herriot. This concludes our prepared remarks, and we will 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 one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. As a reminder, we ask you please ask one question, then return to the queue. Our first question today is coming from Kripa Devarakonda from Truist Securities. Your line is now live.
Hey, guys. Thank you so much for taking my question. On AUVELITY, I was wondering if you can talk a little bit about the sample to paid conversion. Now that you have a full quarter of the agitation launch, how are the earliest patient cohorts progressing from samples to paid packs, maintenance prescriptions, et c? 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. That said, we are seeing positive NBRx growth among sampled HCPs and expect that trend to continue based on our expectations.
Thank you. Next question is coming from Rudy Li from Wolfe Research. Your line is now live.
Hey, thanks for taking my question. It's just a quick follow-up to Ami's question. I think most investors still use Rexulti as a bar for ADA commercial uptake, which was launched like three years ago. Can you maybe help us understand the key differences now in market dynamics and the marketing strategy versus Rexulti? Any color would be helpful. Thanks.
Sure. As a reminder, we don't typically comment on products that aren't our own. As you know, AUVELITY and Rexulti 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. From our perspective, there's clear focus on educating on the clinical profile for AUVELITY, 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. 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. 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%-45% since the launch has started. In 3Q, you had the sell side, you have come above that. Just when you think about the 4Q consensus and 2027 consensus, do you think that this is at the right place, or do you think that it needs to come down a little bit? Thanks.
Sure. Hey, Ash. So Q3, we came in at $207.6 million, and we don't give specific guidance for Q4 or for 2027, but we did see robust growth from Q3 to Q2, and we expect to see continued growth in AUVELITY, specifically with the refills that we would see from the NBRx growth that we saw. 26% growth sequentially Q2 versus Q1, and then 21% Q3 and Q2. So we would expect that to turn, those NBRxs turning into TRxs.
Thank you. Next question today is coming from Leo Timashev 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, if they're having any trouble converting from free to paid? Just anything you can comment there. Thanks.
Yeah. Thanks, Leo. I assume you're referring to Alzheimer's agitation patients specifically. 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 their income. What we've seen is good 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 Marc Goodman from Leerink 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, Marc. Yeah, so the GTN for the quarter improved to the mid to high 40s in Q3. We were around 50% in Q2, so we would anticipate that that GTN 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 GTN 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.
For 2027, I think you asked, Marc, how would we anticipate GTN to look for AUVELITY? Similar to 2026. Low 50s is where we were in Q1, approximately 50% 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 Gerberry from Bank of America. Your line is now live.
Hey, guys. Thanks for taking my question. I have a non-AUVELITY ADA question. Just on the phase III start for AXS-20 in schizophrenia, I am curious how you guys are thinking about approaching this trial in a setting where we are 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 III trial design to help mitigate that just general risk in endeavoring in a schizophrenia phase III? Thanks.
Thanks for the question. The placebo response is something that we think about quite a lot as we design all of our studies. We have experience dealing with the high placebo response rate in other indications. For example, MDD is notorious for having a high placebo response rate. ADHD, same thing. Even when we have conducted parallel group trials, we have been able to implement a lot of bells and whistles. These are small changes to our clinical trial protocols, some of which are proprietary, which we have 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 Amsellem from Piper Sandler. Your line is now live.
Hey, thanks. Wanted to drill down on the long-term care channel and how you're thinking about that opportunity in ADA as we move through 2027. What's your dialogue been like with institutions? Just remind us how you're 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 AUVELITY's clinical profile has been very positive, and there's a clear value proposition for LTC facilities to prescribe AUVELITY compared to other treatment options. As you know, LTC sales involve multiple nursing home stakeholders, LTC pharmacy chains, provider groups that are contracted to care for residents. 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 AUVELITY moving forward.
Thank you. Our next question today is coming from Sean Laaman from Morgan Stanley. Your line is now live.
Good morning, team. Hope everyone's well. In the under 65 TRx with AUVELITY, 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 have seen significant growth, which we expect to continue as the sales force continues to become more effective and more productive. This expectation is really based on what we have seen as it relates to new patient initiations. 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 sales force expansion, for patients 65 and younger, monthly TRx were approximately 67,000, and as of September 2026, TRx were approximately 88,200, representing approximately 32% growth. So we are very pleased with the early impact of the sales force 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 AXS-20 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. That's just further back in the pipeline, so we wanted to highlight the later stage programs. There's no change to our plans there.
Thank you. Next question is coming from Andrew Tsai from Jefferies. Your line is now live.
Morning. Thanks for the update. The NBRx data for the 65 + age group looks quite healthy. I think it's 99% quarter-over-quarter. When do you think the NBRx inflection will meaningfully catch 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. As it relates to the under 65, we've been very pleased. The NBRx, 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. 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. Next question is coming from Joseph Thome from TD Cowen. 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 Rexulti? Are they coming from prior SNRI off-label use? Maybe where are you finding maybe the most interest in terms of the specific patient population? I guess if you're interacting with a physician and maybe they're not ready to use AUVELITY 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. 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 Yatin Suneja from Guggenheim Securities. Your line is now live.
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 is progressing as expected. There are just under six months to go. Nothing out of the ordinary from where we are at this stage. 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 AXS-12 clinical profile that's been demonstrated across our clinical trials. 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 Wells Fargo. Your line is now live.
Hey, great. Thank you. Just on AUVELITY, 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 AUVELITY? Anything in terms of distribution or updating hospital EMR systems? Is there anything that needs to naturally happen that might maybe open up this AD agitation launch a bit more?
Yeah, thanks, Ben, for the question. In terms of the ramp, we shared on the prepared remarks that NBRx in 65 and older grew 211% year-over-year, and TRx have grown about 78% since the approval. 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 prescribing at this point in time.
Thank you. Next question is coming from Brian Skorney from Baird. Your line is now live.
Hey, good morning. Thank you for taking my question. Back on AUVELITY, just trying to get a feel for any prescription abandonment you are seeing. I would assume the vast majority of Medicare patients would have already covered their annual out-of-pocket cap. Is that the case? Are you seeing any active formulary management in the Advantage plans? 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 has been our observation if you compare ADA and MDD. However, there is nothing outside of the ordinary as it relates to abandonment, and there has really been no disruption regarding Medicare Advantage plans. We have worked really hard to secure access with no PA requirements, and the feedback we have 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 Fadia from Needham & Company. Your line is now live.
Hi. Good morning. Thanks for taking my question. Just with regards to the upcoming data readout for ORY-2001 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 are 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. 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're looking for is a safety profile which is consistent with the safety profile that has been established for solriamfetol. We like the fact that this is a drug which is very efficacious in the current indications, and which is also incredibly well tolerated.
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 a significant advance for patients.
Thank you. Next question is coming from David Hoang from Deutsche Bank. Your line is now live.
Hi there. Good morning. Thanks for taking my question. Wanted to ask about, we have obviously visibility to third-party vendor script trends going through October for several weeks. From your end, 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 AUVELITY, that is? Thank you.
Yeah, thanks for the question, David. 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. 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 Graig Suvannavejh from Mizuho. Your line is now 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 IQVIA? I think by our look, maybe IQVIA 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.
Sure thing. Yeah, capture rates 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 were 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 were made aware of that.
Thank you. Next question is coming from Matthew Hershenhorn from Oppenheimer. Your line is now live.
Hey, guys. Thank you for taking the question. Congrats on all the progress. For us, we were wondering about balipodect in schizophrenia, just as you initiate the phase III 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 Cobenfy and CAPLYTA. Basically, what unmet needs do you still see in the market currently that balipodect could potentially address, just thinking through the mechanism? If you could please comment on your current appetite and capacity for additional BD deals, that would be great. Thank you.
What we like about this novel PDE10A inhibitor is that already in a control study, there was a very strong efficacy signal. 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. 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.
In addition to that, we believe that this mechanism of action may have relevance for other indications. We've mentioned Tourette's syndrome, but there are other indications too that we are contemplating evaluating with this novel mechanism of action.
Thank you.
Sure. I think there was a second question that got snuck in there on BD. As it relates to additional BD deals, we did do two transactions over the last couple quarters, specifically around schizophrenia and epilepsy, AXS-17 and AXS-20. 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 AUVELITY.
Thank you. Next question is coming from Myles Minter from William Blair. Your line is now live.
Hey. Thanks for taking the questions. Just on solriamfetol for binge eating disorder and 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? Then just anything on potential dose response between the 150 mg and the 300 mg dose versus 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. We're done. The language that we put in there is, as you know, when you're enrolling clinical trials, even when you do complete enrollment, there might be patients who are still in screening, and 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 El-Saadi from B. Riley Securities. Your line is now live.
Hi. Thanks for taking our question. I have one on AXS-20. 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.
We're developing it as a first-line therapy. Studies that have been conducted have been with AXS-20 over CAPLYTA as a single agent, and so we would be replicating that study in a phase III trial.
Thank you. Our next question is coming from Ram Selvaraju from H.C. Wainwright. Your line is now live.
Thanks so 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 SYMBRAVO 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. With respect to AXS-14 in 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.
Yeah, thanks. I'll start with the question on SYMBRAVO 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 SYMBRAVO access. I can't give you a specific increase in covered lives moving forward, but we are continuing to engage on SYMBRAVO, which has really established itself as a meaningful treatment option, particularly for patients who have had an inadequate response to prior acute migraine treatment. We'll share additional updates as we have them.
Great. To the second part of your question regarding AXS-17, the timeline for reporting data is a little hard to predict because this is a randomized withdrawal study. We've given guidance as to enrollment. Once the study enrolls, then the way that randomized withdrawal studies work is you wait for the pre-specified number of relapses. As it relates to timing of filing of an NDA, we would be ready to file an NDA very shortly after we finish the study. Typically, this is roughly six months. In this case, it could be less than that. The reason for that is that this would be a resubmission. As a reminder, we have completed already two positive studies, a phase II trial and a phase III trial. 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 Stavropoulos from Cantor Fitzgerald. 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. For AXS-12 or reboxetine, with the first approval of an orexin-2 receptor agonist, how are you thinking about the underlying commercial opportunity for reboxetine in the narcolepsy market? More specifically, have you had discussions with payers around the profile and possible pricing, and how are you 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 medications. We believe that AXS-12 as a treatment option will be well-received and adopted. Our engagement with payers thus far has been very positive. They 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 AXS-12.
Thank you. We appreciate our question-and-answer session. I turn the floor back over for your further closing comments.
Thank you. Axsome 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. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.