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DATE
Mon, Nov. 2, 2026
CALL PARTICIPANTS
- Senior Director of Investor Relations - Ashley Dong
- Chief Executive Officer - Herriot Tabuteau
- Chief Financial Officer - Nick Pizzie
- Chief Commercial Officer - Ari Maizel
- Chief Operating Officer - Mark L. Jacobson
- General Counsel - Hunter Murdock
TAKEAWAYS
- Total Revenue -- $259.7 million, representing 52% growth year over year and 19% sequentially.
- AUVELITY Net Product Sales -- $207.6 million, growing 53% year over year driven by demand in major depressive disorder and Alzheimer’s disease agitation.
- SUNOSI Net Product Revenue -- $48.2 million, increasing 47% year over year, including $38.5 million in net product sales, $1.2 million in royalties, and $8.5 million in milestone revenue.
- SYMBRAVO Net Product Sales -- $3.9 million, representing 88% growth year over year as the expanded sales team drives adoption in the migraine market.
- Net Loss -- $12.9 million, or $0.25 per share, representing an improvement from a net loss of $47.2 million, or $0.94 per share, in the third quarter of 2025.
- AUVELITY Total Prescriptions -- Approximately 302,000, growing 40% year over year and 14% sequentially.
- AUVELITY New-to-Brand Prescriptions (65+) -- Increasing 211% year over year and 99% sequentially, reflecting growth in the Alzheimer’s disease agitation indication.
- SUNOSI Total Prescriptions -- 64,400, representing 15% growth year over year and 6% growth sequentially.
- SYMBRAVO Total Prescriptions -- 25,000, growing 382% year over year and 7% sequentially.
- Gross Margin -- Healthy in the 90% to 95% range.
- AUVELITY Gross-to-Net Discount -- Improved to the 45% to 49% range from approximately 50% in the second quarter.
- SYMBRAVO Gross-to-Net Discount -- Reported in the 80% to 89% range.
- Selling, General, and Administrative Expenses -- $203.1 million, compared to $150.2 million in the prior year, primarily due to commercialization activities for AUVELITY and SYMBRAVO.
- Research and Development Expenses -- $50.6 million, compared to $40.2 million in the third quarter of 2025, reflecting late-stage clinical program costs.
- Cash Position -- $313.9 million as of Sept. 30, 2026, which management expects will fund operations through cash flow positivity.
- AUVELITY Payer Coverage -- Approximately 89% total lives, including 82% of commercial lives and 100% of lives in the government channel.
- AXS-12 PDUFA Target Action Date -- May 1, 2027, for the treatment of cataplexy in narcolepsy.
- Solriamfetol (Binge Eating Disorder) -- Management anticipates top-line results from the Phase III ENGAGE trial in the first quarter of 2027.
- AXS-05 (Smoking Cessation) -- Top-line results from the SUMMIT Phase III trial are anticipated in the second half of 2027.
- Solriamfetol (ADHD) -- Top-line results from FOCUS-2 and FOCUS-3 Phase III trials in children and adolescents are expected in the second half of 2027.
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RISKS
- Pizzie stated, "We anticipate gross and net discounts for both products to increase slightly in Q4 due to typical seasonality," noting an expected accrual for scripts that will adjudicate in the first quarter.
- Pizzie warned that a third-party data issue may impact tracking, as "a pharmacy chain stopped reporting scripts in October to 1 of the data providers," potentially affecting TRx and NBRx numbers.
- Maizel noted that "abandonment in Medicare is generally higher than what is observed in commercial," which management is monitoring specifically for the Alzheimer’s disease agitation segment.
SUMMARY
Axsome Therapeutics, Inc. (NASDAQ:AXSM) reported accelerated revenue growth in the third quarter, surpassing a $1 billion annual run-rate driven by the expansion of AUVELITY into the Alzheimer’s disease agitation market and sustained momentum in depression. Management reported significant operational leverage as net losses narrowed while revenue grew 52% year over year. The company confirmed that its cash balance of $313.9 million is sufficient to reach cash flow positivity. The product pipeline is advancing toward several key milestones in 2027, including a PDUFA date for AXS-12 and Phase III data readouts across multiple indications for solriamfetol and AXS-05.
- Management reported activating 8,200 new AUVELITY prescribers during the quarter, bringing the total number of unique prescribers to 77,000.
- Primary care has become the fastest-growing segment for AUVELITY, representing nearly 40% of prescribers and 25% of total prescriptions in the quarter.
- The long-term care channel is tracking growth rates similar to the 65 and older age cohort, though Maizel noted that "the sales cycle can be a little longer in facilities" compared to community settings.
- AXS-20 is progressing toward a pivotal Phase III trial in schizophrenia, which management plans to initiate in the first half of 2027.
- The FDA does not currently plan to hold an advisory committee meeting for the AXS-12 NDA review in narcolepsy.
- The company expects peak annual revenue for AUVELITY to reach at least $8 billion across its approved indications.
INDUSTRY GLOSSARY
- ADA: Alzheimer's Disease Agitation.
- ADHD: Attention Deficit Hyperactivity Disorder.
- CNS: Central Nervous System.
- DNRI: Dopamine and Norepinephrine Reuptake Inhibitor.
- EDS: Excessive Daytime Sleepiness.
- MDD: Major Depressive Disorder.
- NBRx: New-to-brand prescriptions, indicating new patient starts.
- NMDA: N-methyl-D-aspartate, a glutamate receptor and ion channel protein found in nerve cells.
- PDE10A: Phosphodiesterase 10A, an enzyme that breaks down signaling molecules in the brain.
- TRx: Total prescriptions.
Full Conference Call Transcript
Operator: Good morning, and welcome to the Axon Therapeutics Third Quarter 26 Earnings Conference Call. My name is Kevin. I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will be given at that time. Please note this call is being recorded. We will now turn the call over to Ashley Dong, Senior Director of Investor Relations. Ashley, please go ahead.
Ashley Dong: Thank you. Good morning, everyone. Welcome to Axsome's Third Quarter 26 Earnings Conference Call. Joining me today are Dr. Herriot Tabuteau, Chief Executive Officer; Nick Pizzie, Chief Financial Officer; and Ari Maizel, Chief Commercial Officer. We will begin with prepared remarks. Mark L. 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. And with that, I will hand it over to Ari.
Herriot Tabuteau: 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 $2 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 patients in Alzheimer's disease agitation. SUNOSI continues to show persistent and steady growth. And 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 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.
Nick Pizzie: Thanks, Herriot, and good morning, everyone. Total revenue reached $260 million in the third quarter, representing accelerated growth of 52% year-over-year and 19% sequentially. AUVELITY net product sales were 208 million representing 53% year-over-year growth, an increase of over 15% sequential growth. Sequential increases over the past 2 quarters more than doubled the average quarterly increase prior to 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 net discount for SYMBRAVO was in the mid-80% range. Gross net discounts for AUVELITY improved to the mid- to high 40s range. Sunosi also improved into the high 40s range for the third quarter. We anticipate gross and 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 the 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 million compared with $150 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. And with that, I would like to turn the call over to Ari for a commercial update.
Ari Maizel: Thanks, Nick, and good morning, everyone. I am pleased to share the progress across our portfolio of 3 approved medicines, particularly the growing momentum behind AUVELITY. Overall, total prescriptions reached approximately 302 thousand in the third quarter. An increase of 40% year-over-year and 14% sequentially. Significantly outpacing the antidepressant market, which grew 3% and 2% over 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. 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 8.2 thousand new AUVELITY prescribers. Representing 49% growth versus the prior quarter, and bringing the total number of unique prescribers to 77 thousand. 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% 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 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 Cymbravo. Which grew 382% versus Q3 25 and 7% sequentially, more than 25 thousand total prescriptions. Outperforming the migraine market, grew 6% versus Q3 25 and 4% sequentially. New prescriber growth from the neurology and primary care segments underscores the growing place in treatment for Cymbravo 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 64.4 thousand 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 25 and experienced a 2% increase versus the prior quarter. Nearly 17.6 thousand 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 and migraine, and durable growth for Sunosi and EDS associated with narcolepsy and obstructive sleep apnea. Axsome 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 Herriot.
Herriot Tabuteau: 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 3-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 27. We also continue to advance our label expansion clinical programs for solriamfetol across 4 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 solriamfetol in children and adolescents are enrolling, with top line results from both studies anticipated in the second half of 27. These 2 studies, if positive, together with the previously completed positive focus Phase III trial of solriamfetol in adults would form the basis of an sNDA filing for solriamfetol in the treatment of ADHD.
In binge eating disorder, targeted enrollment has been reached in our ENGAGE Phase III trial, and we are on track for top line results in the first quarter of 27. Top line results for our SUSTAIN Phase 3 trial of solriamfetol in shift work disorder are anticipated in the second half of 27. And 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 27. 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 27.
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 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 AXS-14, our FORWARD Phase III trial in fibromyalgia is advancing, and we anticipate completion of enrollment in the third quarter of 27. 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 alpha-2/3 subtype selective positive allosteric modulator. We plan to initiate clinical trials for this molecule in epilepsy in the first half of 27. 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.
Ashley Dong: Thanks, Herriot. This concludes our prepared remarks. 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 1 question. Kevin, please open the line.
Operator: Sir, we will now be conducting a question-and-answer session. You may press star 2 if you like to remove your question from the queue. And as a reminder, we ask you please ask 1 question then return to the queue. Our first question today is coming from Joon Lee from Truist Securities. Your line is now live.
Analyst: 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 cetera, and is this in line with your internal expectations? Thank you so much.
Ari Maizel: Yes. Thanks for the question. So we are 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.
Operator: Our next question is coming from Guofang Li from Wolfe Research. Your line is now live.
Analyst: Thanks for taking my question. it is just a follow-up to the previous question. So I think most investors still use Rexulti as a bar for ADA commercial uptake, which was launched, like, 3 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.
Ari Maizel: Sure. Yeah. As a reminder, we do not comment on products that are not our own. And as you know, AUVELITY results here different products, with different mechanisms. And 1 would expect different launch dynamics, which is what we are seeing. As it relates to the market, there is still significant education required in this marketplace. In some ways, this is still a new and developing market. With a little precedent And so from our perspective, there is clear focus on educating on the clinical profile for AUVELITY.
But there is 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 for patients and care partners to and improve quality of life overall. So from our perspective, this is still a relative new and developing market, but we are very encouraged by what we have seen thus far. And see plenty of opportunity for ongoing education. Thank you.
Operator: Next question is coming from Ashwani Verma from UBS. Your line is now live.
Ashwani Verma: 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 has not met investors' expectation with the stock down 40% to 45% since the launch has started. And 3Q, like you had the sell side account. Have. 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 think that it needs to come down a little bit? Thanks.
Nick Pizzie: Sure. Hey, Ashley. So yes, so Q3, we came in at $207.6 million and we do not 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 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.
Operator: Next question today is coming from Leonid Timashev from RBC Capital Markets. Your line is now live.
Leonid Timashev: Hey, guys. Thanks for taking my question. I just want to ask on real-world pair dynamics. Obviously, you guys have good coverage in the channels. But what are you seeing on the ground with respect to how patients are managing co pays? How they are converting, if they are having any trouble converting from free to paid. Just anything you can comment on there. Thanks.
Ari Maizel: Yeah. Thanks, Leonid. I assume you are referring to Alzheimer's agitation patients specifically. And with Medicare, we have worked really hard to ensure access and coverage for patients. Obviously, every patient is different based on their coverage, based on their income. And what we have seen is good dispensing rates for patients that are prescribed the product would suggest that not only are they getting coverage, but the affordability has been manageable for them. Of course, that is 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 have been really pleased with how patients have been able to fill prescriptions once written. Thank you.
Operator: Next question is coming from Marc Goodman from Leerink Partners. Your line is now live.
Marc Goodman: 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 are expecting fourth quarter and 2027 Seems like it came down a little more than we expected in the quarter. Thanks.
Nick Pizzie: Sure, Mark. Yes. 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 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 2 weeks of inventory on hand at the end of any given quarter. So those 2 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, Mark, you know, 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 forties as we shared in Q3, and a slight tick up from that Q3 number this quarter for Q4. Thank you.
Operator: Next question today is coming from Jason Gerberry from Bank of America. Your line is now live.
Jason Gerberry: Hey, guys. Thanks for taking my question. I have a non AUVELITY ADA question. Just on the Phase III start for AXS-20, schizophrenia. Curious how you guys are thinking about approaching this trial. In a setting where we are seeing a trend of rising placebo rates and placebo responses in schizophrenia trials, anything unique that you guys think you can employ or deploy in a Phase III trial design to help mitigate that just general risk of endeavoring in schizophrenia Phase III? Thanks.
Herriot Tabuteau: Thanks for the question. So placebo response is something that we think about quite a lot as we design all of our studies. We have experienced 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. And even when we conducted parallel group trials, we have been able to implement a lot of bells and whistles. So 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.
Operator: Our next question is coming from David Amsellem from Piper Sandler. Your line is now live.
David Amsellem: Hey, thanks. So I wanted to drill down on the long-term care channel and how are you thinking about that opportunity in ADA as we move through 2027? what is your dialogue been like with institutions? And just remind us how you are thinking about the opportunity in LTC relative to the broader ADA opportunity? Thank you.
Ari Maizel: Yes. 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 is 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. 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 facilities, we are pleased with early progress, and believe it will be an important source of business for AUVELITY moving forward. Thank you.
Operator: Our next question today is coming from Sean Laaman from Morgan Stanley. Your line is now live.
Sean Laaman: Good morning, team. Hope everyone is 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.
Ari Maizel: Yes. Thanks so much. As it relates to both the approval of ADA and the Salesforce expansion, we have seen significant growth which we expect to continue as the Salesforce continues to become more effective and more productive. And 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 new-to-brand. NBRx for patients 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 thousand. And as of September 2026, TRx were approximately 88.2 thousand 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.
Operator: Our next question today is coming from Malcolm Hoffman from BMO Capital Markets. Your line is now live.
Malcolm Hoffman: 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.
Herriot Tabuteau: Hey, thanks for the question. There is no change. that is still of interest. We are--you know, that is just further back in the pipeline. So we wanted to highlight the you know, the later stage programs. But there is no change to our plans there. You.
Operator: Next question is coming from Andrew Tsai from Jefferies. Your line is now live.
Andrew: Good morning. Thanks for the update. The NBRx data for the 65+ age group looks quite healthy. Think 99% quarter over quarter. So 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 months to quarters away kind of thing? Thank you.
Ari Maizel: Yes. Thanks for the question. As it relates to the 65 we have 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 indications, Prior to launch, monthly TRx for patients 65 and older were approximately 8.3 thousand. And as of September 2026, TRx were approximately 14.8 thousand representing 78% growth since the approval. So we are 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. You.
Operator: Next question is coming from Joseph Thome from TD Cowen. Your line is now live.
Joseph Thome: 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 SSRI/SNRI off label use? Maybe where are you finding maybe the most interest in terms of the specific patient population And I guess if you are interacting with a physician and maybe they are not ready to use, AUVELITY for their ADA patient yet, Maybe what is the main reason, and how can you address that? Thank you.
Ari Maizel: Yes. 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 have heard is that patients who are both naive to treatment as well as treatment-experienced 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 is 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 has not 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.
Operator: Next question today is coming from Yatin Suneja from Guggenheim Securities. Your line is now live.
Yatin Suneja: 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 how you are thinking about the market, the segment of the market, where the competitive dynamic are shifting on the narcolepsy space? Thank you so much.
Mark L. Jacobson: Hey, this is Mark. I will take the first part of that. So with respect to the review, and the review is progressing as expected. They are just under 6 months to go. Nothing out of the ordinary from where we are at this stage. Reminder, the PDUFA date is May 1. So launch, prelaunch activities are underway. Oh, and just 1 other thing, a reminder, FDA does not currently plan to hold an AdCom. And I will turn it over to Ari for the second part of the question.
Ari Maizel: Yeah, we are really pleased with the AXS-12 clinical profile that is 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.
Operator: Next question is coming from Benjamin Burnett from Wells Fargo. Your line is now live.
Benjamin Burnett: Hey, great. Thank you. Just on AUAUVELITY, I wanted to touch back again on the adoption ramp that you are seeing in ADA. Are there any natural bottlenecks within the system you just have to contend with given this is a new indication for AUVELITY? 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?
Ari Maizel: Yes. Thanks, Benjamin, 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. So we are pleased with the progress we have 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 is nothing standing in the way of prescribing at this point in time.
Operator: Our next question is coming from Brian Skorney from Baird. Your line is now live.
Brian Skorney: Hey, good morning. Thank you for taking the question. Back on AUVELITY, just trying to get a feel for any prescription abandonment you were 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 is. 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 anticipate that being kind of a headwind or tailwind going into next year? Thanks.
Ari Maizel: Yes. 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 is been our observation. If you compare ADA and MDD, However, there is nothing outside of the ordinary as it relates to abandonment. And there is really been no disruption regarding 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 dynamic for agitation. Thank you.
Operator: Next question is coming from Ami Fadia from Needham and Company. Your line is now live.
Ami Fadia: Hi, good morning. Thanks for taking my question. Just with regards to the upcoming data readout for solriamfetol and 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.
Herriot Tabuteau: Thanks for the question. This will be the first study that we have conducted in binge eating disorder. So what we are looking to see, first of all, is a separation from placebo. For the 2 doses that we are 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 solriamfetol. 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 is only 1 other product that is currently approved in the marketplace, which is highly scheduled.
And which also has a 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.
Operator: Next question is coming from David Hoang from Deutsche Bank. Your line is now live.
David: Hi, there. Good morning. Thanks for taking my question. I want to ask about we have obviously visibility to third party vendor script trends going through October for several weeks. From your end, how to the 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.
Ari Maizel: Yes. Thanks for the question, David. Q4 is shaping up based on our expectations, continued growth in both indications. Obviously, we still have 2 months left in the quarter. Our team is focused on driving NBRx growth across both indications. And continued penetration of primary care setting. So it is premature to suggest what Q4 and obviously we do not guide on quarters moving forward, but we are feeling very good about the overall business trends and, you know, look forward to closing out the year on a high note. Thank you.
Operator: Next question is coming from Graig Suvannavejh from Mizuho Securities. Your line is now live.
Greg: 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 rate state relatively consistent, but maybe ticked up higher Bloomberg Symphony data. Maybe you can comment on what you saw, for this last quarter. Thanks.
Nick Pizzie: Sure, Greg. 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 are made aware that a pharmacy chain stopped reporting scripts in October. To 1 of the data providers, which may also be impacting the TRxs or NBRx. Numbers. Obviously, it is a third party provider. We do not have any other additional detail around that. But just, we are. We were not made aware of that. Thank you.
Operator: Next question is coming from Matthew Hershenhorn from Oppenheimer. Your line is now live.
Matthew Hershenhorn: Hey guys, thank you for taking the question. Congrats on all the progress. First, were wondering about AXS-20 schizophrenia as you initiate the Phase III early next year, how you are, envisioning beyond that potential real-world advantages just based on the mechanism compared the profiles of some of the other novel agents out there like KarXT and Caplyta, Basically, unmet needs do you still see in the market currently that, believe it, 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.
Herriot Tabuteau: So what we like about this novel PDE10A inhibitor is that already in a controlled study there was a very strong efficacy signal, and also given the mechanism of action 1 of the benefits which was seen in that study and also in animal studies is the lack of metabolic side effects. So that is 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 very serious side effects they are seen with atypical antipsychotics, then we think 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 have mentioned Tourette syndrome, but there are other indications too that we are contemplating evaluating with this novel mechanism of action.
Nick Pizzie: As it relates to sure, I will just I think it was a second question that got snuck in there on BD. As it relates to additional BD deals, we did do these transactions over the last couple of quarters, specifically around schizophrenia. Epilepsy AXS-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 AUVELITY. Thank you.
Operator: Next question is coming from Myles Minter from William Blair. Your line is now live.
Myles Minter: Hi, thanks for taking the questions. Just on solriamfetol for binge eating disorder in the ENGAGE study, you mentioned that target enrollment had been achieved, but that enrollment had not necessarily been complete. Is that just sort of like a 10% buffer above the 450 patients that you expect? Or are you over-enrolling somehow? And then just anything on potential dose response between the 150 and the 300-mg dose versus placebo. Do not think you saw that in ADHD but if there is a possibility of seeing it here and binge eating disorder? Thanks very much.
Herriot Tabuteau: 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 are done. And the language that we put in there is, as you know, when you are enrolling 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 are very confident in reporting top line results shortly in the first quarter. Thank you.
Operator: Our next question today is coming from Madison Wynne El-Saadi from B. Riley Securities. Your line is now live.
Madison Wynne El-Saadi: Hi, thanks for taking our question. I have 1 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.
Herriot Tabuteau: So we are developing it as a first line therapy. Studies that have been conducted have been with AXS-20 as a monotherapy as a single agent. And so we would be replicating that study in a Phase III trial. Thank you.
Operator: Our next question is coming from Raghuram Selvaraju from H. C. Wainwright. Your line is now live.
Raghuram Selvaraju: Thanks 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 Cimbravo 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 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.
Ari Maizel: Yes. Thanks. I will start with the question on SYMBRAVO access. Obviously, we are engaged with payers in both the government and commercial channels. As you know, it is 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. So cannot 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. So we will we will share additional updates as we have them.
Herriot Tabuteau: Great. So onto, the second part of your question regarding AXS-14, the timeline for reporting data is a little hard to predict because this is a randomized withdrawal study. So we have given guidance as to enrollment. So once the study enrolls, then the way that randomized withdrawal studies work is you wait for the prespecified number of relapses. Now 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. So typically this is roughly 6 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 2 positive studies, a Phase II trial and a Phase III trial. So within 6 months of reporting top line results for the currently enrolling study, we would be ready to file an NDA. Thank you.
Operator: Next question is coming from Pete Stavropoulos from Cantor Fitzgerald. Your line is now live.
Samantha: Hi, this is Pete on for Samantha. Congrats on the quarter and thanks so much for taking our question. For AXS-12 or with the first approval of an orexin-2 receptor agonist, how are you thinking about the underlying commercial opportunity for AXS-12 in the narcolepsy market? And 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 and sizable opportunity, which I believe you estimate me to be about 185 thousand in the U.S. Thanks so much.
Ari Maizel: Yeah. Thanks for the question. As I shared earlier, we are really pleased with the profile of AXS-12 that we saw in the clinical trials. And also that, you know, patients in this market have really inconsistent response to existing medication. So 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 do not 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.
Operator: We reached the end of our question-and-answer session. I will turn the floor back over for any further or closing comments.
Herriot Tabuteau: 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 towards key clinical 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.
Operator: Thank you. That does conclude today's teleconference. You may disconnect your line at this time and have a wonderful day. Thank you for your participation today.
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