Axsome Therapeutics, Inc. Q2 FY2025 Earnings Call

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.

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, underscoring 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 four 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 three 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.

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 gross to net should 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, 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.

Thank you, Nick. The second quarter of 2025 marked Axsome's first with three 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 wake-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 three 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.

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

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?

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.

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 28 million lives are adjudicated. Obviously, the utilization management will be significantly improved access to patients, and with that benefit, we're still able to maintain that mid-50s gross to net for Auvelity.

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?

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. 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 three 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. It's a little early to tell exactly how AXS-12 will be used relative to other products. But it's once-daily dosing, and we are very optimistic that it will find a place in the treatment paradigm. As for 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 we feel confident based on feedback from KOLs that AXS-12 will have a meaningful place in the treatment paradigm.

And any data you're able to – or what kind of data might be shared in the NDA package?

Sean, the NDA package is going to be comprised of the three 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.

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? What are the next steps in removing those barriers?

Yes. Thanks for the question. So regarding SYMBRAVO, we have a sampling program alongside a patient savings program for eligible commercially insured patients. In the early days, we are seeing a nice utilization of both those programs. It is very common for migraine patients to start with the sample to gauge the 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 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. We are seeing covered claims in the early days, which is a positive signal of the access that we do have, and providing support through our patient savings program is a good supplement to the existing access that's in the market today.

I guess mine's just on SYMBRAVO revenue recognition. My sense was that both Q2 and Q3 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 scripts, I presume, flow through with a better gross to net assumption? 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?

Thanks, Jason, for the question. So maybe I'll talk a little bit about the revenue recognition specifically this quarter in Q2. Obviously, it was a very short quarter with just about two weeks. So wholesale has been placed there. There are minimal stocking orders, their initial stocking orders in June. So any of those orders were recognized as revenue along with the gross to net 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?

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 in that refill rates are not quite as substantial because these are episodic episodes of migraine. They may experience anywhere from a few migraine attacks a month to up to a dozen or 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. In terms of the dynamics that you're referring to, we do have coverage today. We are seeing covered claims in the marketplace. Not all patients are relying on our co-pay support to build the script. It is still very early days. This will be something we'll continue to monitor. One other point that I'll make is that we are seeing scripts flow through from across all channels, so commercial, Medicare, Medicaid, and those dynamics will also evolve. I think we'll have more to share on those dynamics as the year progresses.

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. Given the differences in data and mechanisms, what are your expectations for adoption? Are you expecting to mirror Rexulti? And how do you plan to drive uptake in the other various channels if approved?

Yes. Thanks for the question, Steve. Obviously, we're following the Rexulti launch very closely. We are seeing nice demand, particularly in the Medicare channel. This bodes well for AXS-05. One of the key elements that you highlighted is the difference in terms of mechanism of action, but what we're hearing from healthcare 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 off-label atypical antipsychotics or Rexulti. 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 since there's a large overlap in MDD and EVA prescribing, particularly among psychiatrists and primary care clinicians. 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. This is 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.

So on Auvelity, I'm trying to understand if your gross to net has stayed stable from Q1 to Q2 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?

Sure, Ash. Yes, thanks for the question. This is Nick. So gross to net 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 two-week mark. That being said, with higher demand, there's obviously an inventory impact of an increase in revenue for Q2 versus Q1, again, maintaining at that two-week level. Tertiary, I would share that there is a small change of estimate from the previous quarter as it relates to how we look at potential liabilities as of the end of Q1. We were favorable from that perspective. That is also included in the revenue. But to be clear, there is no inventory impact at all as it relates to Auvelity; it remains at that two-week level.

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? 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 it 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?

Ram, it's Nick again. I'll start with SYMBRAVO and then discuss the gross to nets before passing it to Ari. As I mentioned, SYMBRAVO's gross to net was in the low 80% range for Q2. We expect it to stay high for the latter half of the year. New prescriptions are moving forward quickly; we are ensuring patients receive products, which will likely lead to a full buy-down. The gross to net is expected to remain high for the rest of the year.

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 two or more. 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. Patients that had a good response to a triptan NSAID combo are looking for the utility of a single product to minimize some of the pill burden. That is another area that we've heard very early on. But again, it's still very early in the launch. I anticipate that there will be additional patient types to break through. There is a ton of dissatisfaction among patients in this market. Despite the fact that there are multiple options available, there are still many breakthrough symptoms or tolerability issues that really position SYMBRAVO as a great option.

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? How do you plan to move forward with this?

Thanks for the question, Marc. The precision medicine approach that we referred to relates to solriamfetol for major depressive disorder. We know that there are different patient types in depression. This is a way of targeting the pathophysiology or one of the aspects of the pathophysiology of MDD, which relates to some patients either experiencing excessive sleepiness or insomnia. That's the precision medicine approach. 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, we do know that there is a continuum of the disease from when patients have it as children into adulthood. We demonstrated efficacy in adult patients. We think this builds really well for demonstrating efficacy in the pediatric population, both children as well as adolescents.

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? Additionally, your comments on greater utilization among general practitioners 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?

Yes. Thanks for the questions. We saw continued stability in terms of early-line usage for Auvelity at approximately 50%, really no change. This is the second, third-line dynamic. We are comfortable with that. We've shared previously that one of the benefits of Auvelity is its strong effectiveness, regardless of prior treatment experience. 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 the primary care market. 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 total prescriptions over the course of the year. We're comfortable with where we are right now and will continue to monitor market dynamics to evaluate for the future.

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 is sufficient?

Thanks, Cerena. We announced earlier this spring our pre-NDA meeting minutes where we aligned with the FDA on the submission. Since then, we've been completing the bills of the submission, which is on track for this quarter.

This is John on for Andrew. 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 community centers or long-term care? Is there any low-hanging fruit from the very beginning? 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?

Yes. I'll start with the commercial strategy question. It's a little early to share too many details, but we track utilization of Alzheimer's disease education prescriptions across both outpatient and long-term care facilities. 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. Part of our commercial strategy will be to focus on the highest-value prescribers within a particular space, and I expect that will be maintained for an AXS-05 launch.

With respect to a potential advisory committee, we've not received any indication that the FDA is looking to hold one. However, that's always something they notify you upon acceptance of a filing. As a reminder, there was not one held for Auvelity and MDD. The psychiatry division did hold one for the product Rexulti in an indication where they talked about endpoints, the scale used, which is the same scale that we use, etc. It's really hard to speculate. But again, we're not aware of one at this time and have received communication as such. If there were one to occur, we'd be ready for it.

This is Asim Rana on behalf of Joon. I have a question regarding smoking cessation. The propane is already approved for this purpose. Are there any plans for a head-to-head study of AXS-05 against another treatment?

Thanks for the question. AXS-05 does combine two axes, and therefore, for the product to be approved, there needs to be a demonstration of component contribution. By definition, any registration study would involve a bupropion arm.

Yes. We have three distinct sales forces for each product: approximately 300 representatives for Auvelity and approximately 100 each for Sunosi and SYMBRAVO.

It was a great quarter. I have a question about Auvelity and the MDD dynamics. You have direct-to-consumer efforts underway and are expanding the sales force. I would like to understand when we might expect an inflection point and what kind of changes we should anticipate in these two areas. Also, could you provide insight into the duration you are observing in the marketplace?

Yes. So regarding Auvelity on MDD, we're very pleased with the performance so far this year. One correction I'll make is, although 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. 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 leading indicator for total prescription demand growth or increased trajectory. We'll pay close attention to performance in the back half of the year, but we expect continued growth progress over the course of the year. Once we launch DTC, we expect that to be incremental growth to the current trends. In terms of giving you a specific estimate in terms of step change, it's premature, particularly because we're announcing this access win starting in July. You can imagine that sales force expansion, improved access, and then DTC later this year will provide incremental growth for the brand. In terms of duration, we see an average of around six to seven prescriptions over the course of the year. Some patients respond well to treatment and refill every month; others may have an adequate response or drop out of treatment. But on average, it's around that number.

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 insight on that. Can you go into more detail on what gives you confidence from the adult data we saw earlier this year that solriamfetol will be active in pediatric patients? This trial seems to have taken a little bit of time to get off the ground. 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's making it a little more challenging?

Great. Thanks for the question. The pediatric study will have a standard parallel group design. One of the differences between the adult and pediatric studies is the differences in the scale. We'll be using a pediatric scale as opposed to the adult study. In terms of what gives us confidence that the adult data will translate into pediatric data, we're conducting clinical trials to test hypotheses, so nothing is guaranteed. However, other drugs for ADHD that have been active in patients have been active in both adults and pediatric patients. Biologically, it would make sense since adult patients must have been diagnosed with ADHD as children; that's part of the diagnostic criteria. There is a layer of complexity when dealing with pediatric patients. We want to ensure we have perfect alignment with the agency regarding the design of any trial in a pediatric population.

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? How do you think about your overall strategy in narcolepsy with both Sunosi and AXS-12, especially regarding competitive dynamics in polypharmacy?

Yes, thanks for the question. There's near-perfect overlap in terms of targets for AXS-12 and Sunosi, so we'll be able to leverage our current Sunosi team fully for the AXS-12 launch. This is a real synergistic opportunity for us in the company. As I mentioned previously, we see a lot of polypharmacy in the space as clinicians seek to optimize treatment based on the unique symptomatology that patients present. With AXS-12 and Sunosi having distinct indications, you may see some combination use. It's a little too soon to tell. Clinicians will want to weigh in based on the final label. But we're optimistic and have heard a lot of enthusiasm for the potential benefits of both products in patients. Like the other treatments that exist, we expect various combinations to be used with the currently approved treatments.

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

Yes, I'll start with the seasonality question. There is some seasonality really across all three of the markets that we're currently in. Depression is perhaps the most pronounced. We expect with SYMBRAVO, because it's early in the launch, you may not observe a true seasonality effect since the brand is growing from a relatively low base. However, there is some seasonality in the summer months regarding lightering, EDS, and depression.

As for Auvelity and you mentioned IRA pricing, this is presumably related to ADA. ADA will be priced at the same wholesale acquisition cost as Auvelity, so $1,177 in the current WAC price. We would be up for negotiations somewhere around 2029 or 2030, with potential implementation in the '31 or '32 range.

This is Sam on for David. On Sunosi, anything you all would highlight regarding what drove the strong quarter and specifically with respect to the patient mix between narcolepsy and OSA. As a follow-on to a prior question on Auvelity, do you feel the need to further increase covered commercial labs from here?

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 active writers in the quarter. Not only did we have a higher number than the previous quarter, but they were also more productive, meaning they prescribed more Sunosi than in previous quarters. This reinforces our strategy to drive depth of prescribing within the existing EDS marketplace for ACT. On the commercial lives, we are pleased with the announcement today, but we are at 83% covered lives in total. Our goal is to cover as much of the insurance market as possible. We believe we still have work to do, and we expect to continue to add additional coverage over time.

Just 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 the pediatric and adolescent population would be sufficient for potential approval here as opposed to the guidance, which keeps bringing up the two positive pediatric studies, one 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?

Sure. We'll have more to say, but there are strategies to include both children and adolescents in one study. The reason for the guidance is to ensure that we effectively determine which dose will be effective in both those patient subpopulations. There are strategies to achieve this in one study, along with demonstrated efficacy in the adult population, as ADHD is a continuum. Stay tuned; our goal has always been to develop products in a streamlined fashion.

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.

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.

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.