Axsome Therapeutics Q3 2026 Earnings Call Transcript

Axsome Therapeutics (NASDAQ:AXSM) reported third-quarter financial results on Monday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Axsome Therapeutics reported a 52% increase in total revenue to $259.7 million for Q3 2026, driven by strong sales of Auvelity, Sunosi, and Simbravo.

The company highlighted significant growth in new-to-brand prescriptions for Auvelity, particularly in Alzheimer’s disease agitation and major depressive disorder.

Axsome’s neuroscience pipeline includes 10 development programs with upcoming clinical and regulatory milestones, such as AXS-05 for smoking cessation and solriamfetol for various disorders.

The company expects its current cash balance of $314 million to fund operations until it achieves cash flow positivity.

Management expressed confidence in continued strong performance, with potential for Auvelity to reach $8 billion in annual revenue at peak.

Full Transcript

OPERATOR

Good morning and welcome to the Axsome Therapeutics third quarter 2026 earnings conference call. My name is Kevin and 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.

Ashley Dong (Senior Director of Investor Relations)

Good morning everyone. Welcome to Axsome Therapeutics’ 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. And with that, I’ll hand it over to Herriot.

Herriot Tabuteau (Chief Executive Officer)

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 and for Simbravo, 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.

Nick Pizzie (Chief Financial Officer)

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 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. Simbravo net product sales were $3.9 million in the quarter, representing 88% year over year growth. The gross-to-net discount for Simbravo 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 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 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 Simbravo. 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’d like to turn the call over to Ari for a commercial update.

Ari Maizel (Chief Commercial Officer)

Thanks Nick and good morning everyone. I’m pleased to share the progress across our portfolio of three approved medicines, particularly the growing momentum behind 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 Simbravo, which grew 382% versus Q3 2025 and 7% sequentially to more than 25,000 total prescriptions, outperforming the migraine market which grew 6% versus Q3 2025 and 4% sequentially. New prescriber growth from the neurology and primary care segments underscores the growing place in treatment for Simbravo for patients who experience inadequate response to prior acute migraine treatment options. Prescriber and patient feedback consistently highlights Simbravo’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 Simbravo 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 Simbravo 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 United States for years to come. I will now turn the call back to Herriot.

Herriot Tabuteau (Chief Executive Officer)

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 3 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 3 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 3 trial of solriamfetol in adults, would form the basis of an NDA filing for solriamfetol in the treatment of ADHD.

In binge eating disorder, targeted enrollment has been reached in our ENGAGE Phase 3 trial and we are on track for top-line results in the first quarter of 2027. Top-line results for our SUSTAIN Phase 3 trial of solriamfetol in shift work disorder are anticipated in the second half of 2027. And enrollment completion for our CLARITY Phase 3 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 3 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 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 3 trial in fibromyalgia is advancing and we anticipate completion of enrollment in the third quarter of 2027.

If positive, the FORWARD study, along with the previously completed positive Phase 2 and Phase 3 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.

Ashley Dong (Senior Director of Investor Relations)

Thanks, Ari. This concludes our prepared remarks and we’ll now begin the Q&A session. To allow enough time for as many questions as possible, we kindly ask that you limit yourself to one question. Kevin, please open the line.

OPERATOR

Certainly. We will now be conducting a question-and-answer session. If you’d like to be placed into the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you’d like to remove your question from the queue. And as a reminder, we ask you please ask one question, then return to the queue. Our first question today is coming from Kripa Dericondo from Truist Securities.

Your line is now live.

Kripa Dericondo (Analyst at Truist Securities)

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. How are the earliest patient cohorts progressing from samples to paid packs, maintenance prescriptions, etc.? And is this in line with your internal expectations? Thank you so much.

Ari Maizel (Chief Commercial Officer)

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.

OPERATOR

Thank you. Our next question is coming from Rudy Lee from Wolfe Research. Your line is now live.

Rudy Lee (Analyst at Wolfe Research)

Thanks for taking the question. It’s just a quick follow-up to Ami’s question. So I think most investors do 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.

Ari Maizel (Chief Commercial Officer)

Sure. Yeah. 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. And so 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. So from our perspective this is still a relatively new and developing market, but we’re very encouraged by what we’ve seen thus far and see plenty of opportunity for ongoing education.

OPERATOR

Thank you. Next question is coming from Ash Verma from UBS. Your line is now live.

Ash Verma (Analyst at UBS)

Guys, thanks for taking my question. So for ADA, I know you talked about that the launch has met your internal expectation, but it seems that it hasn’t met investors’ expectation with the stock down 40 to 45% since the launch has started. In 3Q, you had the sell side 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?

Nick Pizzie (Chief Financial Officer)

Sure. Hey, Ash. So yeah, so Q3 we came in at 207.6, 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 versus Q2. So we would expect those NBRxs to turn into TRxs.

OPERATOR

Thank you. Next question today is coming from Leona Timishev from RBC Capital Markets. Your line is now live.

Leona Timishev (Analyst at RBC Capital Markets)

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 what are you seeing on the ground with respect to how patients are managing copays, how they’re converting, if they’re having any trouble converting from free to paid? Just anything you can comment there. Thanks.

Ari Maizel (Chief Commercial Officer)

Yeah, thanks, Leo. I assume you’re referring to Alzheimer’s agitation patients specifically. And 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. And 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.

OPERATOR

Thank you. Next question is coming from Mark Goodman from Leerink Partners. Your line is now live.

Mark Goodman (Analyst at Leerink Partners)

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.

Nick Pizzie (Chief Financial Officer)

Sure, Mark. 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 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, Mark, 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.

OPERATOR

Thank you. Next question today is coming from Jason Gerberry from Bank of America. Your line is now live.

Jason Gerberry (Analyst at Bank of America)

Hey guys, thanks for taking my question. I have a non-Auvelity/ADA question. So just on the Phase 3 start for AXS-20 in schizophrenia, I’m curious how you guys are thinking about approaching this trial in a setting where we’re seeing a trend of rising placebo rates—placebo responses—in schizophrenia trials. Anything unique that you think you can employ or deploy in a Phase 3 trial design to help mitigate that just general risk in endeavoring in a schizophrenia Phase 3?

Herriot Tabuteau (Chief Executive Officer)

Thanks for the question. So the placebo response is something that we think about quite a lot as we design all of our studies. We had experience dealing with the high placebo response rate in other indications. For example, MDD is notorious for having a high placebo response rate. ADHD, same thing. And even when we conducted parallel-group trials, we’ve 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’ve developed over the past several years, and we fully intend to use those in any study that we would design in psychiatry.

OPERATOR

Thank you. Our next question is coming from David M. Sullivan from Piper Sandler. Your line is now live.

David M. Sullivan (Analyst at Piper Sandler)

Hey, thanks. So, wanted to drill down on the long-term care channel and how you’re thinking about that opportunity in ADA as we move through ’27. What’s your dialogue been like with institutions? And just remind us how you’re thinking about the opportunity in LTCs relative to the broader ADA opportunity. Thank you.

Ari Maizel (Chief Commercial Officer)

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, and provider groups that are contracted to care for residents.

And so it is distinct from community settings where the HCP is the primary target. Although the sales cycle can be a little longer in LTC facilities, we are pleased with early progress and believe it’ll be an important source of business for Auvelity moving forward.

OPERATOR

Thank you. Our next question today is coming from Sean Marvin from Morgan Stanley. Your line is now live.

Sean Marvin (Analyst at Morgan Stanley)

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.

Ari Maizel (Chief Commercial Officer)

Yes, thanks so much. As it relates to both the approval of ADA and the sales force expansion, we’ve seen significant growth, which we expect to continue as the sales force continues to become more effective and more productive. This expectation is really based on what we’ve seen as it relates to new patient initiations. So as you mentioned, 65 and younger, we saw significant growth in NBRx, which is the metric we use to track MDD. NBRx for patients under 65 grew 27%. When you think about where we were before the 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’re 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.

OPERATOR

Thank you. Our next question today is coming from Malcolm Hoffman from BMO Capital Markets. Your line is now live.

Malcolm Hoffman (Analyst at BMO Capital Markets)

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 (Chief Executive Officer)

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, but there’s no change to our plans there.

OPERATOR

Thank you. Next question is coming from Andrew Tsai from Jefferies. Your line is now live.

Andrew Tsai (Analyst at Jefferies)

Good morning. Thanks for the update. The NBRx data for the 65-plus age group looks quite healthy—I think 99% quarter to quarter. So when do you think the NBRx inflection will meaningfully catch up to TRx exactly? Are we talking days or weeks away, or is this kind of months to quarters away kind of thing? Thank you.

Ari Maizel (Chief Commercial Officer)

Yeah, thanks for the question. You know, as it relates to the under 65, you know, we’ve been very pleased. You know, 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. And as of September 2026, TRx were approximately 14,800, representing 78% growth since the approval. So we’re pleased.

We expect the upward trajectory to continue, and our focus on new patient initiations will also continue, which will support ongoing and persistent demand.

OPERATOR

Thank you. Our next question is coming from Joseph Tone from TD Cowen. Your line is now live.

Joseph Tone (Analyst at TD Cowen)

Hi there. Good morning, and thank you for taking the 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 naïve? Are they coming from prior Rexulti? Are they coming from prior SSNRI off-label use? Maybe where are you finding maybe the most interest in terms of the specific patient population? And I guess if you’re interacting with a physician and maybe they’re not ready to use Auvelity for their ADA patient yet, maybe what’s the main reason and how can you address that?

Thank you.

Ari Maizel (Chief Commercial Officer)

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 naïve 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’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.

OPERATOR

Thank you. Next question today is coming from Yatin Suneja from Guggenheim Securities. Your line is now live.

Yatin Suneja (Analyst at Guggenheim Securities)

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 dynamics are shifting in the narcolepsy space. Thank you so much.

Mark Jacobson (Chief Operating Officer)

Hey, this is Mark. I’ll take the first part of that. So with respect to the review, 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 1, so launch prelaunch activities are underway. Oh, and 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.

Ari Maizel (Chief Commercial Officer)

Yeah, we’re really pleased with the AXS-12 clinical profile that’s been demonstrated across our clinical trials. And given the heterogeneity in the narcolepsy market and the inconsistent clinical response that patients have with existing medications, we believe the more treatment options, the better.

OPERATOR

Thank you. Next question is coming from Ben Burnett from Wells Fargo. Your line is now live.

Ben Burnett (Analyst at Wells Fargo)

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? So, 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 AD agitation launch a bit more?

Ari Maizel (Chief Commercial Officer)

Yeah, thanks, Ben, for the question. In terms of the ramp, you know, 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, you know, we’re pleased with the progress we’ve made in terms of adoption. Related to the bottlenecks, there are no major bottlenecks that we can see. I think in the early days, certainly EMR systems and e-prescribing systems need to be updated with new dosage and administration forms and things of that nature. But there’s nothing standing in the way of prescribing at this point in time.

OPERATOR

Thank you. Our next question is coming from Brian Scorney from Baird. Your line is now live.

Brian Scorney (Analyst at Baird)

Hey, good morning. Thank you for taking the question. Back on Auvelity, just trying to get a feel for any prescription abandonment you’re seeing. I would assume the vast majority of Medicare patients would have already covered their annual out-of-pocket cap. Is that the case? And are you seeing any active formulary management in the Advantage plans? And just wondering, are you seeing any disruption due to all the Advantage plans that have been shut down, or do you anticipate that being kind of a headwind or tailwind going into next year?

Ari Maizel (Chief Commercial Officer)

Yeah, thanks for the question. As it relates to abandonment, generally speaking, abandonment in Medicare is generally higher than what is observed in commercial, and certainly that’s been our observation. If you compare ADA and MDD, however, there’s nothing outside of the ordinary as it relates to abandonment. And there’s really been no disruption regarding Medicare Advantage plans. We’ve worked really hard to secure access with no PA requirements, and the feedback we’ve received is that patients are getting access and filling prescriptions at a very high rate.

So overall we feel very good about the Medicare dynamics for agitation.

OPERATOR

Thank you. Next question is coming from Ami Fadia from Needham & Company. Your line is now live.

Ami Fadia (Analyst at Needham & Company)

Hi, good morning. Thanks for taking my question. Just with regards to the upcoming data readout for solriamfetol in binge eating disorder, from a commercial standpoint, what type of profile would be competitive in terms of the efficacy and the safety profile that you’re looking to see from the results? Thank you.

Herriot Tabuteau (Chief Executive Officer)

Thanks for the question. This will be the first study that we’ve conducted in binge eating disorder. So what we’re looking to see, first of all, is a separation from placebo for the two doses that we’re testing. The other thing that we’re 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’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.

OPERATOR

Thank you. Next question is coming from David Holm from Deutsche Bank. Your line is now live.

David Holm (Analyst at Deutsche Bank)

Hi there. Good morning. Thanks for taking my question. Want to ask about—you know, 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.

Ari Maizel (Chief Commercial Officer)

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 the primary care setting. So I think it’s premature to suggest what Q4—and obviously we don’t guide on quarters moving forward—but we are feeling very good about the overall business trends and look forward to closing out the year on a high note.

OPERATOR

Thank you. Next question is coming from Greg Zavanovez from Mizuho. Your line is now live.

Greg Zavanovez (Analyst at Mizuho)

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 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.

Nick Pizzie (Chief Financial Officer)

Sure, Craig. Yeah, capture rate this quarter did appear to fluctuate a bit, potentially due to the addition of new pharmacies with the launch in ADA specifically. IQVIA seems to be impacted the most—that decreased to somewhere around 90%. Additionally, we’re made aware that a pharmacy chain stopped reporting scripts in October to one of the data providers, which may also be impacting the weekly TRx or NBRx numbers. Obviously it’s a third-party provider; we don’t have any other additional detail around that, but we were made aware of that.

OPERATOR

Thank you. Next question is coming from Matthew Hershenhorn from Oppenheimer. Your line is now live.

Matthew Hershenhorn (Analyst at Oppenheimer)

Hey guys, thank you for taking the question. Congrats on all the progress for us. We were wondering about Bellipoduct and schizophrenia just as you initiate the phase three early next year, how you’re envisioning beyond that potential real world advantages just based on the mechanism compared to the profiles of some of the other novel agents out there like Cobenfi and Keplyta. Basically what unmet needs do you still see in the market currently that Bilipa 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 (Chief Executive Officer)

So what we like about this novel PDE10A inhibitor is that already in a control study there was a very strong efficacy signal. And also given the mechanism of action, one of the benefits which was seen in that study and also in animal studies is the lack of metabolic side effects. So that’s just a highlight of the favorable safety profile of this product candidate. So if you can maintain or generate greater efficacy than is seen with the current agents, as well as getting rid of some of the very serious side effects that are seen with atypical antipsychotics, then we think that that would be a very meaningful advance to patients with schizophrenia.

Now, in addition to that, we believe that this mechanism of action may have relevance for other indications. So we’ve mentioned Tourette Syndrome, but there are other indications too that we are contemplating evaluating with this novel mechanism of action.

Matthew Hershenhorn (Analyst at Oppenheimer)

Thank you.

Nick Pizzie (Chief Financial Officer)

Sure. I’ll just— I think there was a second question that got snuck in there on BD as it relates to additional BD deals. You know, we did do these two transactions over the last couple quarters specifically around schizophrenia and 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.

OPERATOR

Thank you. Next question is coming from Miles Minter from William Blair. Your line is now live.

Miles Minter (Analyst at William Blair)

Hey, thanks for taking the questions. Just on Soriantol 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 and then just anything on potential dose response between the 150 and the 300 mg dose for placebo? Don’t think you saw that in ADHD, but if there’s a possibility of seeing adhering binge eating disorder.

Thanks very much.

Herriot Tabuteau (Chief Executive Officer)

Great. So enrollment is basically completed and we are on track to report top line results in the first half of the first quarter. So we’re done. And you know that the language that we put in there is, as you know, when you enroll in 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.

OPERATOR

Thank you. Our next question today is coming from Madison Elsadi from B. Riley Securities. Your line is now live.

Madison Elsadi (Analyst at B. Riley Securities)

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.

Herriot Tabuteau (Chief Executive Officer)

So we’re developing it as a first line therapy. Studies that have been conducted have been with AXS-20 as a single agent. And so we would be replicating that study in a phase three trial.

OPERATOR

Thank you. Our next question is coming from Ram Savaradru from ACUA Regularize Live.

Ram Savaradru (Analyst at ACUA Regularize Live)

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 Simbravo over the course of the remainder of this year and into early 2027. And when you anticipate the vast majority of covered lives to ultimately have access to that product. And then with respect to AXS-14 in fibromyalgia, can you just give us a sense of the timing of release of top line data from the phase three 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 (Chief Commercial Officer)

Yeah, thanks. I’ll start with the question on Simbravo 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 Simbravo access. So I can’t give you a specific increase in covered lives moving forward, but we are continuing to engage on Simbravo, which has really established itself as a meaningful treatment option, particularly for patients who have had an inadequate response to prior acute migraine treatment.

So we’ll share additional updates as we have them.

Herriot Tabuteau (Chief Executive Officer)

Great. So 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. So we’ve given guidance as to enrollment. So once the study enrolls, then the way that randomized withdrawal studies work is you wait for the pre-specified number of relapses. Now, as it relates to timing of filing of an NDA, we would be ready to file an NDA very shortly after we finish the study.

So typically this is roughly six months. In this case it could be less than that. And the reason for that is that this would be a resubmission. As a reminder, we have completed already two positive studies, a phase two trial and a phase three trial. So within six months of reporting top line results for the currently enrolling study, we would be ready to file an NDA.

OPERATOR

Thank you. Next question is coming from Pete Stravopoulos from Cantor. Pancho, your line is now live.

Samantha (Analyst at Cantor Fitzgerald)

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 ruboxetine, with the first approval of an orexin 2 receptor agonist, how are you thinking about the underlying commercial opportunity for ruboxetine 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 but sizable opportunity, which I believe you estimate to be about 185,000 in the U.S.?

Thanks so much.

Ari Maizel (Chief Commercial Officer)

Yeah, thanks for the question. You know, as I shared earlier, we’re really pleased with the profile of AXS-12 that we— in the clinical trials, and also that patients in this market have really inconsistent response to existing medications. 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 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.

OPERATOR

Thank you. We reached the end of our question and answer session. I’d like to turn the floor back over for any further closing comments.

Herriot Tabuteau (Chief Executive Officer)

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.

OPERATOR

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.

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