Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q2 2025 Earnings Call Transcript

Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q2 2025 Earnings Call Transcript August 4, 2025

Axsome Therapeutics, Inc. beats earnings expectations. Reported EPS is $-0.92, expectations were $-1.

Operator: Good morning, and welcome to the Axsome Therapeutics Second Quarter 2025 Financial Results Conference Call. [Operator Instructions] Please note this call is being recorded. I would now like to turn the call over to Darren Opland, Director of Corporate Communications at Axsome Therapeutics. Please go ahead.

Darren Opland: Thank you, and good morning, everyone. Thank you all for joining us for our second quarter 2025 earnings call. With me today are Dr. Herriot Tabuteau, our Chief Executive Officer; Nick Pizzie, our Chief Financial Officer; and Ari Maizel, our Chief Commercial Officer, who will begin our call with prepared remarks. Mark Jacobson, our Chief Operating Officer; and Hunter Murdock, our General Counsel, will join us for the Q&A portion of the call. This morning, we issued our earnings press release providing a business update and details of the company’s financial results for the second quarter of 2025. I encourage everyone to visit the Investors page of our website to find our press release and the presentation related to today’s call.

Before we begin, please note that today’s discussion includes certain forward-looking statements regarding, among other things, the efficacy, safety and intended utilization of our investable agents, our clinical and nonclinical plans, our plans to present or report additional data, the anticipated conduct in the source of future clinical trials, regulatory plans, future research and development plans, commercial plans and the possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions and expectations of future events that are subject to change and involve risks and uncertainties that may cause the actual results to differ materially from those contained in the forward- looking statements.

These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to rely on these forward-looking statements, which are made only as of today’s date, and the company disclaims any obligation to update such statements. I’ll now turn the call over to Herriot.

Herriot Tabuteau: Thank you, Darren, and thank you all for joining us this morning. Axsome delivered a strong second quarter, reflecting focused execution across our commercial business and development pipeline. Demand for our end market products saw robust growth, and we continue to advance multiple late-stage development programs targeting several important neuroscience indications with significant unmet needs and substantial market opportunities. We delivered total revenue of $150 million for the quarter, representing substantial double-digit year-over-year and sequential growth driven by outperformance for both Auvelity and Sunosi. Nick and Ari will provide additional details on the accelerating dynamics for these important life-changing medicines.

We are also excited to have recently launched SYMBRAVO, our third approved product and our second product that has been developed wholly in-house. This launch represents a significant milestone for Axsome and for the millions of patients with migraine who desire new treatment options to manage the burdensome symptoms of this condition. Ari will comment on the early feedback from the product thus far. All in all, we are encouraged by the accelerating trajectory of our commercial portfolio. In parallel with the commercial progress, we continue to advance our innovative late-stage neuroscience pipeline. Last month, we hosted our Frontiers in Brain Health R&D Day with expert clinicians and key opinion leaders. The event showcased the breadth and depth of Axsome’s potentially first-in-class or best-in-class pipeline, underscore the strength of our clinical data and highlighted our position at the forefront of neuroscience innovation.

I will provide a brief update on the pipeline programs and upcoming milestones. Starting with AXS-05 in Alzheimer’s disease agitation. We are on track to submit the sNDA for AXS-05 in Alzheimer’s disease agitation this quarter. This is a key priority for the organization. and we look forward to keeping everyone updated on our progress for this program. We also continue to make progress on our development plans for AXS-05 for the treatment of smoking cessation with a Phase II/III trial expected to initiate in the fourth quarter of this year. Moving on to AXS-12, our novel product candidate for the treatment of narcolepsy with cataplexy. Progress continues on our NDA submission to the FDA, which is slated for the fourth quarter. In clinical trials to date, AXS-12 has demonstrated the potential to provide meaningful relief across multiple key symptoms of narcolepsy and to address the critical gap in care for this patient population.

For AXS-14 in fibromyalgia, we look forward to initiating a Phase III trial in the fourth quarter to address the FDA’s feedback in the previously disclosed refusal to file letter. With more than 17 million people in the U.S. affected by this condition and with a paucity of approved treatments, we see a substantial opportunity for AXS-14 to transform the standard of care for these patients. Our solriamfetol development programs continue to advance across 4 potentially high-value indications: ADHD, MDD with excessive daytime sleepiness, binge eating disorder and shift work disorder. In ADHD, we previously reported Phase III efficacy results in adults, and we plan to initiate a Phase III trial in pediatric patients in the fourth quarter. In MDD, with excessive daytime sleepiness, we are taking a precision medicine approach based on the clinical presentation and underlying pathophysiology of MDD.

This approach is supported by pilot data from our PARADIGM study, and we expect to initiate a Phase III trial in this patient population in the fourth quarter. Our ENGAGE Phase III trial of solriamfetol in binge eating disorder continues to enroll and remains on track to read out next year. Binge eating disorder is the most common eating disorder, estimated to afflict over 7 million individuals in the U.S. With only one agent approved for this condition, it represents a high unmet medical need. The sustained Phase III trial of solriamfetol in excessive sleepiness associated with the shift work disorder is also progressing with top line results also slated for 2026. With 3 innovative CNS medicines now on the market and multiple late-stage programs advancing toward registration, we continue to build a strong, durable foundation for continued growth and significant long-term value creation.

With that, I’ll hand the call over to Nick, who will provide details of our financial performance.

Nick Pizzie: Thank you, Herriot, and good morning, everyone. Our second quarter performance highlights the growing momentum of Axsome’s commercial portfolio and our continued execution in bringing important medicines to patients. Total product revenues for the quarter were $150 million, driving an increase of 72% year-over-year and an increase of 24% quarter-over-quarter. Auvelity continues to demonstrate impressive growth. Net product sales were $119.6 million, up 84% versus last year and up 24% versus the previous quarter. Sunosi net product revenues were $30 million, up 35% versus last year and up 19% versus the previous quarter. Sunosi revenues in the quarter consisted of $28.9 million in net product sales and $1.1 million in royalty revenue associated with Sunosi sales in out-licensed territories.

SYMBRAVO was launched on June 10, and for this partial quarter generated net sales of $410,000. Auvelity and Sunosi gross to net discounts for the second quarter were both in the mid-50s range. We continue to anticipate Auvelity and Sunosi GTNs will remain in this range for the remainder of the year. SYMBRAVO gross net for the quarter was in the low 80% range. Turning now to expenses. Total cost of revenue were $13.4 million compared to $8.1 million for the second quarter of 2024. Research and development expenses were $49.5 million for the second quarter compared to $49.9 million for the second quarter of 2024. The decrease was primarily related to the completion of solriamfetol trials in ADHD and MDD, along with the completion of the AXS-05 trials in Alzheimer’s disease expectation, which was partially offset by higher personnel costs.

Selling, general and administrative expenses were $130.3 million, compared to $103.6 million for the second quarter of 2024. The increase was primarily related to commercialization activities for Auvelity, including the expansion of the Auvelity sales force and expenses related to the commercial launch of SYMBRAVO. Net loss for the second quarter was $48 million or $0.97 per share, compared to a net loss of $59.4 million or $1.22 per share for the previous quarter and $79.3 million or $1.67 per share for the second quarter of 2024. The $48 million net loss for this quarter includes $24.6 million related to stock-based compensation expenses. We ended the second quarter with $303 million in cash and cash equivalents compared to $315.4 million at the end of 2024.

We continue to believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan. And with that, I’d like to now turn the call over to Ari, who will provide a commercial update.

Ari Maizel: Thank you, Nick. The second quarter of 2025 marked Axsome’s first with 3 marketed products, highlighted by the mid-June launch of SYMBRAVO into the acute migraine market and continued strong demand growth for Auvelity and Sunosi. Our commercial infrastructure powered by Axsome’s proprietary digital-centric commercialization model supported robust business performance in Q2 and enabled rapid market entry for SYMBRAVO with encouraging early signals of the product’s potential. Starting with Auvelity. Auvelity delivered another strong quarter of growth. with increased new patient starts and continued expansion in prescriber engagement supported by our expanded sales force. Auvelity led the market in TRx growth, generating approximately 192,000 prescriptions in Q2, representing 15% quarter-over-quarter growth and 56% year-over-year growth.

By comparison, the antidepressant market grew 2% sequentially and 1% compared to the second quarter of 2024. Auvelity also led the market in new patient prescription growth with nearly 30,000 new patients initiating Auvelity in the quarter, increasing the total number of patients treated with Auvelity since launch to nearly 220,000. A key growth driver in the quarter was the activation of approximately 4,800 new prescribers with about half coming from the primary care setting, another positive index of product adoption. In addition to delivering strong prescription growth, Axsome made significant progress with market access for Auvelity in the quarter with the addition of approximately 28 million new covered lives in the commercial channel starting July 1.

Auvelity coverage now stands at 83% of lives across all channels, including approximately 73% of commercial lives and 100% of government lives. Turning to Sunosi. Total prescriptions in Q2 exceeded $50,000 for the first time, representing 9% sequential growth and approximately 13% growth versus Q2 of last year. By comparison, the waste promoting agent market grew 5.5% sequentially and increased by 5% compared to the second quarter of 2024. Payer coverage for Sunosi remains at approximately 83% of lives covered across channels. Finally, we are proud to have launched SYMBRAVO in mid-June, offering patients with migraine an important new and novel multi- mechanistic treatment option. While still early, just 6 weeks into launch, feedback from the migraine community has been very encouraging with initial patient experiences validating the differentiated profile of SYMBRAVO as an effective, safe and tolerable acute treatment for migraine.

On the access front, we recently executed a commercial contract with one of the 3 largest group purchasing organizations, or GPOs, for potential formulary coverage of SYMBRAVO. Pharmacy benefit managers and health plans under this GPO are now able to make coverage decisions for SYMBRAVO based on the contracted terms. Current coverage for SYMBRAVO is at approximately 38% of lives across all channels, including 26% of commercial lives. We anticipate coverage for SYMBRAVO to expand and evolve throughout the rest of the year. In closing, the second quarter reflected significant growth in Axsome’s product portfolio, highlighted by solid performance from Auvelity and Sunosi, the recent launch of SYMBRAVO and expansion of payer coverage to enhance patient access to our medicines.

We expect continued strong commercial execution to drive momentum across the portfolio during the second half of the year. I will now turn the call back to Darren for Q&A.

Darren Opland: Thanks, Ari. We’re ready to begin our Q&A now. We kindly ask that you limit yourselves to 1 question each so we can get through as many questions as possible. Thank you.

Q&A Session

Operator: [Operator Instructions] Our first question today is coming from Leonid Timashev from RBC Capital Markets.

Leonid Timashev: I wanted to ask a little bit more about the payer coverage expansion for Auvelity. I guess, first of all, given the large number of covered lives added to this, that third contracting organization. And then it sounds like gross to net is not expected to change for the quarter despite all the new covered lives. So I guess I’m curious how you’re thinking about the dynamics and how much volume we should expect to pull forward in the second half of the year?

Ari Maizel: Thanks for the question. Regarding the coverage, this actually represents pull-through of previously announced GPO contracts. And so we were successful at engaging with the pharmacy benefit managers within those previously announced GPOs to secure access for the products. So this is a really good signal of the strong work of our market access team. Obviously, we expect there to be some acceleration in volume, particularly related to these plans. But in terms of overall impact, I think it’s a little too soon to share exactly what the volume expectation or volume growth will be. I think it’s fair to sort of look at last year’s major access win as perhaps an analog for what to expect in terms of demand for the product.

Nick Pizzie: Yes. And as it relates to Auvelity GTN, we shared that we are in the mid-50s in Q2, and we will see how — these new — the new 28 million lives are adjudicated. Obviously, we’ll — the utilization management will be significantly improved access to patients will be significantly improved. And with that benefit, we’re still able to maintain that mid-50s GTN for Auvelity.

Operator: Next question is coming from Sean Laaman from Morgan Stanley.

Sean M. Laaman: I have a question on AXS-12. If you could just frame out a little bit the market positioning against oxybate and the potential orexin 2 agonist coming? And what data might be included in your NDA filing package?

Ari Maizel: Sure. Yes, I’ll start with the question. So first of all, we are really optimistic about the potential profile of AXS-12 in narcolepsy. As we’ve shared previously, over 90% of patients report discontinuing their medication due to inefficacy, the side effect profiles or recommendations from their HCPs to switch treatments. And so AXS-12 will be positioned as a rapid-acting narcolepsy treatment with significant reductions in cataplexy, improvements on areas such as excessive sleepiness and cognitive function, which we observed in our 3 placebo-controlled efficacy trials. One of the things that we’ve learned a lot about is that oftentimes, sleep specialists are looking at combinations of treatment based on the unique patient presentation, and where they’re seeing issues as it relates to symptomatology.

And so it’s a little early to tell exactly how AXS-12 will be used relative to other products. But it’s once daily dosing. We are very optimistic that it will find a place in the treatment paradigm. And as it relates to the orexin, I think, obviously, a really great signal for patients and providers with the top line results that we shared recently. There’s not a ton of data shared, but — so we’ll want to monitor their additional data that’s released, particularly as it relates to the side effect profile, but even with the orexin, we feel confident based on feedback with KOLs that AXS-12 will have a meaningful place in the treatment paradigm.

Sean M. Laaman: And any data you’re able to — or what kind of data might be shared in the NDA package?

Unidentified Company Representative: Sean, the NDA package is going to be comprised of the 3 controlled trials that we conducted. That’s what concert SYMPHONY and ENCORE trial. So all of those studies will be going into the NDA submission, including the long-term safety extension.

Operator: The next question today is coming from Ami Fadia from Needham Company.

Unidentified Analyst: This is [ Poonam ] on for Ami. On SYMBRAVO, could you provide some additional color on a sampling program. What has been the utilization of the drug through sampling and any trends that you’re seeing for conversion of patients from the sampling to the prescription drug? And just in terms of the launch, are you seeing any initial barriers to access or launch in general? With SYMBRAVO? And what are the next steps in removing those barriers?

Ari Maizel: Yes. Thanks for the question. So regarding SYMBRAVO, we have a sampling program alongside a patient savings program for eligible commercially insured patients. And in the early days, we are seeing a nice utilization of both those programs. So it is very common for migraine patients to start with the sample in order to gauge effect of the treatment prior to filling a prescription. But we’ve been encouraged by what we’ve seen thus far, which is samples being accompanied by a prescription and then strong utilization of our patient savings program for commercially insured patients. In terms of overall access, as we mentioned in our release, we have secured coverage for the product, although it’s still very early in the launch, and we expect that to continue to expand and evolve over the course of the year.

But we are seeing covered claims in the early days, which is a positive signal of the access that we do have, and then providing support through our patient savings program is a good supplement to the existing access that’s in the market today.

Operator: Your next question is coming from Jason Gerberry from Bank of America.

Jason Matthew Gerberry: I guess mine’s just on SYMBRAVO revenue recognition, my sense was that both 2Q and 3Q would be light with the co-pay card and I guess the assumption that perhaps you wouldn’t have the contracting up in place with the update that you’re at nearly 40%. I’m just wondering, will the new start script I presume, flow through with better — I guess, better gross to net assumption. And just wondering if you can walk us through the next couple of quarters. Just how to think about revenue recognition and the script data that we’re seeing?

Nick Pizzie: So, thanks, Jason, for your call — for the question. So maybe I’ll talk a little bit about the rev rec specifically this quarter in Q2. Obviously, it was a very short quarter with just about 2 weeks. So wholesale has been placed there. They’re minimal stocking orders, their initial stocking orders in June. So any of those orders were recognized as revenue along with the GTN that we shared in the — or that’s around that 80% range from that perspective. Around the first scripts, Ari do you want to share maybe a little bit about the NBRxs and how we’re approaching them.

Ari Maizel: Yes, Jason, as you know, in the — for early launches, nearly all of the prescriptions are new patient starts and the migraine market is a little bit different than the depression market and that refill rates are not quite as substantial because these are episodic episodes of migraine. And so they may be having anywhere from a few migraines attacks a month to up to a dozen or so. And so what we’re monitoring is what the refill rate will develop over time. That said, we have started to see refills, but we expect that to be at a slightly lower velocity than what we see with Auvelity overall. So in terms of the dynamics that you’re referring to, we do have coverage today. We are seeing covered claims in the marketplace.

And so that means that they’re — not all patients are relying on our co-pay support in order to build the script. It is still very early days. And so that’s something we’ll continue to monitor. One other point that I’ll make is that we are seeing scripts flow through from across all the channels. So commercial, Medicare, Medicaid, and those dynamics will also evolve. So I think we’ll have more to share on those dynamics as the year progresses.

Operator: Next question is coming from Steve Stavropoulos from Cantor Fitzgerald.

Pete George Stavropoulos: Congrats on the execution. It’s on AXS-05 in Alzheimer’s agitation. There’s a clear mechanistic distinction and clinical profile for 05 versus antipsychotics. Rexulti’s uptake has been relatively modest in Alzheimer’s agitation. Sort of given the differences in data and mechanisms, what are your expectations for adoption? Are you expecting to mirror of Rexulti? And how do you plan to drive uptake in the other various channels if approved?

Herriot Tabuteau: Yes. Thanks for the question, Steve. Obviously, we’re following the Rexulti launch very closely. And we are seeing really nice demand, particularly in the Medicare channel. So I think that bodes well for AXS-05. One of the key elements that you highlighted, the difference in terms of MOA, but what we’re hearing from health care providers across the Alzheimer market is that the combination of strong efficacy alongside a really great safety and tolerability profile is what sets AXS-05 apart from the currency used, whether it’s off-label atypical antipsychotics or Rexulti. And so we feel really optimistic if approved, that this will make a tremendous impact on the marketplace. In terms of raising awareness, there will be some benefit to our existing Auvelity sales force in the sense that there’s a large overlap in MDD and EVA prescribing, particularly among psychiatrists and primary care clinicians.

But we’re also cognizant of the fact that we’ll have to expand our promotional efforts to areas like geriatric psychiatry, neurodegenerative specialists as well as long-term care facilities. And so that’s something that we’ll continue to work through as we prepare for a future launch, but we feel really good about the potential for AXS-05 and the receptivity that it will have in the marketplace.

Operator: Next question today is coming from Ash Verma from UBS.

Ashwani Verma: So on Auvelity, I’m trying to understand if your GTN has stayed stable from 1Q to 2Q than the 15% sequential growth that you have, what is driving the 24% net sales growth? Is that primarily inventory? Or is there any other factor that’s contributing to that?

Nick Pizzie: Sure, Ash. Yes, thanks for the question. This is Nick. So GTN did slightly improve. We were in the mid-50s range for both quarters. But did improve within that range from Q1 to Q2. I would say secondly, as you spoke about inventory, inventory remains around that 2-week mark. But that being said, with higher demand there’s obviously an inventory impact of an increase in revenue for Q2 versus Q1, again, maintaining at the Q2 2-week level. And then tertiary, I would share that there is a small change of estimate from previous quarter as it relates to how we look at potential liabilities as of the end of Q1. We were favorable from that perspective. So that is also included in the revenue. But to be clear, there is no inventory impact at all as it relates to, Auvelity remains at that 2-week level.

Ashwani Verma: So can you clarify a potential change of liability from the previous like net sales number or is that…

Nick Pizzie: Yes. I can share that, it’s going to be in the queue, which we’ll file after the quarter, but it was less than $0.5 million. And that’s related to any type of rebates that we would owe that is in channel within those 2 weeks. So we estimate that accrued as of the end of the quarter and then true it up to next quarter as typical as any company would.

Operator: Next question today is coming from Ram Selvaraju from H.C. Wainwright.

Raghuram Selvaraju: With respect to SYMBRAVO, I was just wondering if you could give us some additional color on how you expect both gross to nets as well as coverage percentages to trend over the course of the remainder of this year? And also, if you could comment on any color from physicians as well as patients regarding what you see as the main differentiator for this product relative to the other migraine products on the market? In other words, is this the efficacy in those patients who have historically proven intractable to management with other anti-migraine drugs? Is it the onset of action or some other factor?

Nick Pizzie: Ram, it’s Nick again. For — I’ll start with SYMBRAVO and then related to the GTS and then hand it over to Ari. As I mentioned, SYMBRAVO GTN was in the low 80% range for Q2. We expect it to remain high for the back half of the year. As already shared, NBRx is out of the gate, we’re making sure patients receive products, so that would be likely a full buy down. And as that proportion is still going to be high for the remaining part of the year and to TRx is we would expect GTN to also remain high. Ari?

Ari Maizel: Yes. And related to some of the color from the clinicians and patients, I think first and foremost, the fact that SYMBRAVO offers a multi-mechanistic approach to acute migraine treatment is very compelling. Most other products are only focusing on one particular pathway. SYMBRAVO is focusing on 2 or more. And therefore, the idea of being able to attack the migraine attack in multiple ways is very compelling. I will say anecdotally, one of the things that we’re hearing from early patient experience is the rapid onset of action and durability of response, which has come through loud and clear from folks who have tried it thus far. In terms of the patient types, what we’re hearing early on is partial triptan responders, folks who are getting some relief but not feeling totally better.

We’re lacking and paying freedom is a key patient type that SYMBRAVO has been used for? And also patients that have had good response to a triptan NSAID combo that are looking for the utility of a single product to sort of minimize some of the pill burden. That is another area that we’ve heard very early on. But again, I would just say that it’s still very early in the launch. I anticipate that there will be additional patient types to break through. And as we know, there’s a ton of dissatisfaction amongst patients in this market. And despite the fact that there are multiple options available, there’s still a lot of breakthrough symptoms or tolerability issues that really positions SYMBRAVO as a great option.

Operator: Next question today is from Marc Goodman from Leerink Partners.

Marc Harold Goodman: Herriot, can you talk about your strategy for this precision medicine approach to ADHD? And does that carry over into the adolescence as well as the adults? And how do you plan to move forward with this?

Herriot Tabuteau: Thanks for the question, Marc. So the precision medicine approach that we referred to relates to solriamfetol for major depressive disorder. And we know that they are different patient types in depression. And — so this is a way of targeting the pathophysiology or one of the aspects of the pathophysiology of MDD, which relates to — was the probably and either some patients either experience excessive sleepiness and others, my experience of insomnia. So that’s the precision medicine approach. So it’s based on looking at the clinical presentation as well as the underlying pathophysiology. As it relates to your question on the other part of your question on ADHD. So there, we do know that there is a continuum of the disease from when patients have it as children into adulthood.

So we demonstrated efficacy in adult patients. And we think that, that builds obviously really well for demonstrating efficacy in the pediatric population, that would be both children as well as adolescence.

Operator: Next question is coming from David Amsellem from Piper Sandler.

David A. Amsellem: On Auvelity and MDD, can you talk to the mix between second and third line usage and even the extent to which you’re getting frontline usage and also with your comments on greater utilization among general practitioners, sort of begs the question, do you think you need to expand the sales force to better target, a broader audience of general practitioners, how are you thinking about that?

Ari Maizel: Yes. Thanks for the questions. We saw continued stability in terms of early line usage for Auvelity at approximately 50%, really no change. It’s sort of the second, third line dynamic. And we’re comfortable with that. I think we’ve shared previously that one of the benefits of Auvelity is that it is a strong effectiveness regardless of prior treatment experience. That said, as access improves and utilization management evolves. We expect early line usage to continue to grow, particularly as we’re able to penetrate the primary care market. We’ve seen nice growth in primary care market. I think we’re very comfortable with the size of the sales force right now. This quarter really underscored the impact of that sales force expansion earlier this year.

We started seeing an inflection in new patient starts late Q1 that continued throughout Q2, which will impact the TRxs over the course of the year. So I think we’re comfortable with where we are right now, and we’ll continue to monitor the market dynamics to evaluate for the future.

Operator: Next question today is coming from Cerena Chen from Wells Fargo.

Yijun Chen: I had a question on AXS-05 for AD agitation. Just wanted to know when was the last time you heard from the current FDA administration that the data package for Ad agitation sufficient?

Unidentified Company Representative: Thanks, Cerena. We had announced a few — earlier this spring, our pre-NDA meeting minutes where we aligned with the FDA on the submission. And since then, we’ve been completing the bills of the submission, which is on track for this quarter.

Operator: Next question is coming from Andrew Tsai from Jefferies.

Unidentified Analyst: This is John on for Andrew. So if we fast forward in 9 to 12 months or so, how are you thinking about the commercial strategy for AXS-05 in terms of penetrating like community centers or long-term care. Is there any low-hanging fruit from the very beginning. And then also thinking about if there was a potential AdCom based on your prior FDA discussions, what would be the key talking points that the FDA would want to discuss in your view?

Ari Maizel: Yes. I’ll start with the commercial strategy question. Yes, it’s a little early to share too many details, but obviously, we tracked utilization of Alzheimer’s disease education prescriptions across both outpatient and long-term care facilities. And so we have a really good idea of where the majority of these patients are being treated and which providers are most active in the space. And so part of our commercial strategy will be to be really focused, like we’ve done with all of our products and highly targeted on the highest or highest-value prescribers within a particular space, and I expect that, that would be maintained for an ADA launch. .

Unidentified Company Representative: And then with respect to a potential advisory committee, we’ve not received any indication that the FDA is looking to hold on. However, that’s always something they notify you upon potential acceptance of a filing. And as a reminder, there was not one held for Auvelity and MDD. And the psychiatry division did hold one for the product that they — for Rexulti in the indication where they talked about a number of things, endpoints, the scale used, which is the same scale that we use, et cetera. It’s really hard to speculate. But again, we’re not aware of one at this time and have received communication as such. And — but if there were one to occur, we’d be ready for it.

Operator: Next question today is coming from Joon Lee from Truist Securities.

Asim Rana: This is Asim Rana on for Joon. Just one on smoking cessation. So the propane is already approved for smoking cessation. Are there any plans to conduct a head-to-head study of AXS-05 against [indiscernible]?

Herriot Tabuteau: Thanks for the question. So AXS-05 does combine 2 axis, and therefore, in order to — for the product to be approved, there does need to be a demonstration of component contribution. So by definition, any registration study would involve a bupropion arm.

Asim Rana: And then can you just remind us on the sales were split across the 3 commercialized products?

Ari Maizel: Yes. So we have 3 distinct sales forces for each product and approximately 300 representatives on Auvelity and approximately 100 each for Sunosi and SYMBRAVO.

Operator: Your next question today is coming from Yatin Suneja from Guggenheim Partners.

Yatin Suneja: Very nice quarter. Just a question on Auvelity and the MDD dynamic. I mean, obviously, you have DTC ongoing, there is sales force expansion. So I’m just curious to understand from you how should we think about the inflection that we should get — when exactly we should anticipate the inflection and what level of step changes we should be expecting within these 2 dynamics. And if you can also comment on the duration that you’re seeing in the marketplace?

Ari Maizel: I missed the last part, about duration?

Yatin Suneja: Last on duration, yes, last one, duration.

Ari Maizel: Okay. Yes. So in terms of Auvelity on MDD, obviously, we’re very pleased with the performance so far this year. One correction I’ll make is, although we have — we have not launched a national DTC campaign, we are expecting to later this year, but that is not currently reflected in our demand trends. So I just want to make sure you’re aware of that. In terms of the inflection regarding sales force expansion, as I mentioned, we began to see an inflection in new patient starts towards the end of Q1 that continued in Q2. Generally speaking, that is the sort of leading indicator for TRx demand growth or increase in trajectory. And so we’ll be paying close attention to performance in the back half of the year, but we would expect there to be continued growth progress over the course of the year.

And then once we launched DTC, we expect that to be incremental growth to the current trends. But in terms of giving you a specific estimate in terms of step change, I think it’s a little too premature particularly because we’re announcing this access win starting in July. You can imagine that the totality of sales force expansion, improved access and then DTC later this year will provide incremental growth rate for the brand. In terms of duration, we’re seeing somewhere around 6-7 prescriptions over the course of the year on average. Obviously, some patients respond well to the treatment and refill every month, others that may have an adequate response or drop out of treatment based on achieving remission. But on average, it’s somewhere around 6 or 7.

Operator: Next question today is coming from Joseph Thome from TD Cowen.

Joseph John-Charles Thome: Congrats on the progress. Maybe on the pediatric ADHD study, can you go into a little bit more detail about what that trial will look like? It seems like the presenting KOL at your Analyst Day had some open on that. And maybe go into a little bit more detail on a prior response, what specifically gives you confidence from the adult data we saw earlier this year that solriamfetol will be active in pediatric patients. And then tangentially, this trial seems to have taken a little bit of time to take it off the ground. I guess how confident are you in that Q4 guidance? Is there anything specific about the pediatric population versus adults in terms of IRB timing or anything like that, that makes it a little bit more challenging?

Herriot Tabuteau: Great. Thanks for the question. As it relates to the pediatric study, we anticipate that would be a standard parallel group design. One of the differences between the adult and pediatric studies is a difference in the scale. So we would be using a pediatric scale as opposed to the adult study, which [indiscernible] adult scale. And in terms of what gives us confidence that the adult data will translate into pediatric data. Well, we’re conducting clinical trials in order to test hypothesis. So nothing is guaranteed, but — if you look at other drugs for ADHD, which have been active in patients, they’ve been active in both adults as well as pediatric patients. And biologically, that would make sense since adult patients must have been diagnosed with ADHD as children.

That’s part of a diagnostic criteria. And as it relates to the timing of the start of the study. It’s — there is a layer of complexity when dealing with pediatric patients. So we want to make sure that we have perfect alignment with the agency as it relates to the design of any trial in a pediatric population.

Operator: Next question is coming from Matthew Hershenhorn from Oppenheimer.

Matthew Baron Hershenhorn: Ahead of the potential launch for AXS-12 next year, could you just talk about how you could leverage your current commercial capabilities in narcolepsy with Sunosi? And how do you think about your overall strategy in narcolepsy with both Sunosi and AXS-12, especially as you think about competitive dynamics in polypharmacy, I really appreciate it.

Ari Maizel: Yes. Thanks so much for the question. There’s near perfect overlap in terms of the targets for AXS-12 and Sunosi, and so we’ll be able to leverage our current Sunosi team fully for an AXS-12 launch. So it’s a real synergistic opportunity for us in the company. As it relates to position, as I mentioned in my earlier comments, we see a lot of polypharmacy in the space as clinicians seek to optimize treatment based on the unique symptomatology that patients present with I think in some ways, the fact that AXS-12 and Sunosi will have distinct indications, you may see some combination use. But I think it’s a little too soon to tell. Clinicians are going to want to sort of weigh in based on final label, et cetera. But we feel very optimistic.

And we’ve heard a lot of enthusiasm for the potential benefit of both products in patients. And so like the other treatments that exist, we expect there to be a whole variety of combinations used of the currently approved treatments.

Operator: Next question is coming from Graig Suvannavejh from Mizuho Securities.

Graig C. Suvannavejh: Just across your 3 products that are now commercial stage, what should we expect with respect to summer seasonality as we think about third quarter sales? And then secondly, if I could ask, could you just remind us again your assumptions or expectations around the potential for IRA pricing, especially for Auvelity and kind of what your current thinking is around timing of when Auvelity might be for such negotiations or discussions? .

Ari Maizel: Yes, I’ll start with the seasonality question. So there is some seasonality really across all 3 of the markets that we’re currently in. I think in some ways, depression is perhaps the most pronounced. Obviously, we expect with SYMBRAVO because it’s early in launch that you may not observe true seasonality effect as the brand is growing from a relatively low base. But there is some seasonality effect in the summer months across lightering, EDS and depression.

Nick Pizzie: Yes. And then as for Auvelity and you mentioned IRA pricing, it’s presumably related to ADA. Again, ADA will be priced at the same WAC price as Auvelity, so $1,177 in the current WAC price. And as a reminder, I think we would be up for negotiations somewhere around 2029, 2030 with a potential implementation in the ’31, ’32 range.

Operator: Your next question is coming from David Hoang from Deutsche Bank.

David Timothy Hoang: This is Sam on for David. On Sunosi, anything you all would highlight what drove the strong quarter and specifically as it relates to the patient mix between narcolepsy and OSA. And as a follow-on to a prior question on Auvelity. Do you feel the need to further increase covered commercial labs from here?

Ari Maizel: Yes. Thanks, Sam, for the questions. Regarding Sunosi, nothing noteworthy regarding the mix of patients, narcolepsy versus OSA, but we did see very strong growth in prescribers this quarter and then active writers in the quarter. Not only did we have a higher number than previous quarter, but — they were also more productive, meaning they were more — they were prescribing more Sunosi than in previous quarters. So I think this really reinforces our strategy to drive depth of prescribing within the existing EDS marketplace for ACT. And I apologize your…

Nick Pizzie: The commercial lives…

Ari Maizel: So on the commercial lives, obviously, we’re very pleased with the announcement for today, but we’re at 83% covered lives in total. And our goal is to get to as much of the insurance market as possible. So we believe we still have work to do. And our expectation is that we continue to add additional coverage as time goes on.

Operator: Our final question today is coming from Myles Minter from William Blair.

Myles Robert Minter: Just one on Sunosi and ADHD and the comment to receive perfect alignment with the regulators. I’m curious as to why you think that a single trial in pediatric and adolescent population would be sufficient for potential approval here as opposed to the guidance, which keeps kind of bringing up the 2 positive pediatric studies, 1 of which could be done in adolescents would be required for approval here. Just wondering whether you’ve received alignment with the agency based on that?

Herriot Tabuteau: Sure. We’ll have more to say, but there are strategies to include both children as well as adolescents in 1 study. So the reason for the guidance is to make sure that one can adequately determine what dose will be effective in both of those patient subpopulations. So there is — there are strategies to be able to do that in 1 study. And in conjunction with having demonstrated efficacy in the adult population, ages of continuum. And so stay tuned, but our goal, as always, has been to develop products in a streamlined and the fashion as possible.

Operator: We have reached the end of our question-and-answer session. I’d like to turn the floor back over for any further or closing comments.

Herriot Tabuteau: Thank you all for joining us today. As you’ve heard on today’s call, Axsome delivered a strong second quarter marked by commercial growth, clinical advancement and disciplined execution across the business with a growing portfolio of innovative commercial and development, neuroscience products. We are well positioned to potentially address serious conditions that affect more than 150 million patients in the U.S. alone. We look forward to keeping you updated on our continued progress over the balance of the year. Thank you.

Operator: Thank you. That does conclude today’s teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.