Axsome Therapeutics, Inc.

Good morning, and welcome to the Axiom Therapeutics Second Quarter 2025 Financial Results Conference Call. Currently, all participants are in listen-only mode. Later, there will be a question-and-answer session, and instructions will be given at that time. Please note, this call is being recorded. I would now like to turn the call over to Darren Oplin, Director of Corporate Communications at Axiom Therapeutics. Please go ahead.

Thank you, and good morning, everyone. Thank you all for joining us for our second quarter 2025 earnings call. With me today are Dr. Ariel Tabuto, our Chief Executive Officer, Nick Pizzi, 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 Murdoch, 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 investor's 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 non-clinical plans, our plans to present or report additional data, the anticipated conduct and 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 Ariel.

Thank you, Darren, and thank you all for joining us this morning. Axiom delivered a strong second quarter, reflecting focused execution across our commercial business and development pipeline. Demand for our in-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 Ovelity and Synose. 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 Axome 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 on 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 Axone's potentially first-in-class or best-in-class pipeline, underscored the strengths 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 AXS05 and Alzheimer's disease agitation. We are on track to submit the SMDA for AXS05 and 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 AXS05 for the treatment of smoking cessation for the Phase 2-3 trial expected to initiate in the fourth quarter of this year. Moving on to AXS12, our novel product candidate for the treatment of narcolepsy with cataplexy. Progress continues in 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 a critical gap in care for this patient population. For AXS-14 and fibromyalgia, we look forward to initiating a phase three 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 salt-reinfatol 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 three efficacy results in adults, and we plan to initiate a phase three 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 three trial in this patient population in the fourth quarter. Our engaged phase three trial of psoriambutol 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 3 trial of solvianfetol and excessive sleepiness associated with 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, Ariel, and good morning, everyone. Our second quarter performance highlights the growing momentum of Axum'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. Avelity continues to demonstrate impressive growth. Net product sales were $119.6 million, up 84% versus last year and up 24% versus the previous quarter. The NOSI net product revenues were $30 million, up 35% versus last year and up 19% versus the previous quarter. The NOSI revenues in the quarter consisted of $28.9 million in net product sales and $1.1 million in royalty revenue associated with NOSI sales in outlicensed territories. Sembravo was launched on June 10th, and for this partial quarter, generated net sales of $410,000. Avelity and Senosi gross net discounts for the second quarter were both in the mid-50s range. We continue to anticipate Avelity and Senosi GTNs will remain in this range for the remainder of the year. Sembravo 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 psoriathral trials in ADHD and MDD, along with the completion of the AXS05 trials in Alzheimer's disease agitation, 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 Avelity, including the expansion of the Avelity sales force and expenses related to the commercial launch of Sombrato. Net loss for the second quarter was $48 million, or 97 cents 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 Axome's first with three marketed products, highlighted by the mid-June launch of Sembravo into the acute migraine market, and continued strong demand growth for Avelity and Senozi. Our commercial infrastructure, powered by Axome's proprietary digital-centric commercialization model, supported robust business performance in Q2 and enabled rapid market entry for Sembravo, with encouraging early signals of the product's potential. Starting with Alvelity, Alvelity delivered another strong quarter of growth with increased new patient starts and continued expansion in prescriber engagement supported by our expanded sales force. Alvelity 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. Alveolity also led the market in new patient prescription growth, with nearly 30,000 new patients initiating Alveolity in the quarter, increasing the total number of patients treated with Alveolity 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, Axo made significant progress with market access for availability in the quarter, with the addition of approximately 28 million new covered lives in the commercial channel starting July 1st. Availability coverage now stands at 83% of lives across all channels, including approximately 73% of commercial lives and 100% of government lives. Turning to Synozy, 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 weight-promoting agent market grew 5.5% sequentially and increased by 5% compared to the second quarter of 2025. Payer coverage for Synose 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 six 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 Simbravo. Pharmacy benefit managers and health plans under this GPO are now able to make coverage decisions for Simbravo based on the contracted terms. Current coverage for Simbravo is at approximately 38% of lives across all channels. including 26% of commercial lives. We anticipate coverage for Sembravo to expand and evolve throughout the rest of the year. In closing, the second quarter reflected significant growth in Axone's product portfolio, highlighted by solid performance from Alveolity and Synosy, the recent launch of Sembravo, 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.

Thank you. We'll now be conducting a question and answer session. If you'd like to be placed into 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 move your question from the queue. Once again, we ask that you please ask one question, then return to the queue so we get through as many questions as possible. Our first question today is coming from Lina Timichet from RBC Capital Markets. Her line is now live.

Hey, thanks, guys. Thanks for taking my question. Congrats on the quarter. I want to ask a little bit more about the payer coverage expansion for Avelity. I guess, first of all, given the large number of covered lives added, is this that third contracting organization? And then I guess 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 dynamic and how much volume we should expect to pull forward in the second half of the year. Thanks.

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 benefits managers within those previously announced GPOs. Um, to secure access for the product. Um, so this is a really good signal of of the strong work on our access team. Um, obviously we expect there to be some, uh, acceleration and volume, particularly related to these plans. Um, but in terms of overall impact, I think it's a little too soon to. 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.

Yeah, and as it relates to VELVI GTN, we shared that we are in the mid-50s in Q2, and we will see how These new 28 million lives are adjudicated. You know, obviously, 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 availability. Thanks. Really appreciate it.

Thank you. Next question is coming from Sean Laman from Morgan Stanley.

Your line is now live. Good morning. I hope everyone's well, and thank you for taking my question. I have a question on AXS-12. If you could just frame out a little bit the market positioning against oxybates and the potential orexin-2 agonists coming, and what data might be included in your NDA filing package? Thank you.

Sure, yeah. I'll start with the the question. So, first of all, we are really optimistic about the potential profile of ASS12 in ortholepsy. As we've shared previously, over 90% of patients report discontinuing their medication due to inadequate efficacy, side effect profiles, or recommendations from their HCPs to switch treatments. And so, ASS12, you know, will be positioned as a 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. I think one of the things that we've learned a lot about is that oftentimes sleep specialists are looking at combinations of treatments 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 accessible 12 will be used relative to other products. But, you know, it is 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 orexins, you know, I think obviously really great signal for patients and providers with the top line results that were shared recently. There's not a ton of data shared, but so we'll want to monitor, you know, their additional data that's released, particularly as it relates to the side effect profile. But even with the orexins, you know, we feel confident based on feedback with KOLs that AXS-12 will have a meaningful place in the treatment paradigm.

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

Hi, Sean. So the NDA package is going to be comprised of the three control trials that we conducted. That's the CONCERT, SYMPHONY, and ENCORE trials. So all of those studies will be going into the NDA submission, including the long-term safety extension.

Wonderful. Thank you. Thank you. Next question today is coming from Ami Fadia from Neiman Company. Your line is now live.

Hi, this is Poonam for Ami. Thank you for taking our question. On Simbravo, 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 Simbravo and what are the next steps in removing these barriers? Thank you.

Yeah, thanks for the question. So, regarding some Bravo, we do 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, it is very common for migraine patient 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, you know, samples being accompanied by a prescription and then a strong utilization of our patient savings program for commercially insured patients. In terms of overall access, you know, as we mentioned on 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.

Great. Thank you.

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

Thanks for taking my question. I guess mine's just on some Bravo revenue recognition. My sense was that both 2Q and 3Q would be light with the copay 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.

Thanks. 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 two weeks. So, wholesalers did place their minimal stocking orders, their initial stocking orders in June. So, any of those orders were recognized as revenue and 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?

Yeah, Jason, as you know, 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. And so they may be having, you know, anywhere from a few migraine attacks a month to, you know, 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 Albelity overall. So in terms of the dynamic that you're referring to, we do have coverage today. We are seeing covered claims in the marketplace. And so that means that not all patients are relying on our copay support in order to fill 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, you know, as the year progresses.

Thank you, guys.

Thank you. Next question is coming in from Steve Stavropoulos from Cancer for Stroke. Your line is now live.

Hi. Good morning, and congrats on the execution, and thanks for taking my question. It's on AA-XS05 in Alzheimer's agitation. You know, there's a clear mechanistic distinction and clinical profile for 05 versus antipsychotics. Rixolti'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 Rixolti? And how do you plan to drive uptake in the other various channels, if approved? Thank you.

Yeah, thanks for the question, Steve. Obviously, we're following the Rixolti launch very closely, and we are seeing really nice demand, particularly in the Medicare channel. So, you know, I think that bodes well for HSO5. You know, one of the key elements that you highlighted, the difference in terms of MOA, 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 AXS05 apart from the currently used, whether it's off-label atypical antipsychotics or Rexalti. And so we feel really optimistic, you know, 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 ability sales force in the sense that there's a large overlap in MDD and EDA 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 AXS05 and the receptivity that it will have in the marketplace.

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

Hi. Thanks for the question. So, on the validity, I'm trying to understand if your GTN has stayed stable from 1Q to 2Q, then 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? Thanks.

Yeah, 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 two-week mark. But that being said, with higher demand, There's obviously an inventory impact of an increasing revenue for Q2 versus Q1. Again, maintaining at the Q2 two-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. favorable from that perspective. So, that also is included in the revenue. But to be clear, there is no inventory impact at all as it relates to availabilities made at that two-week level.

Can you clarify a potential change of liability for the previous net sales number? Sure.

Yeah, I can share that. It's going to be in the queue, which will file after the quarter, but it was less than a half a million dollars. And that's related to any type of rebates that we would owe that is in-channel within those two weeks. So we estimate that accrued as of the end of the quarter and then true it up the next quarter as typical as any company would.

Thank you. Thank you. Next question today is coming from Ram Savaraju from HC Wainwright. Your line is now live.

Thanks so much for taking my question. With respect to Simbrava, 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? Thank you.

Hey, Ram. It's Nick again. I'll start with Simbrava and then relate it to the GCN and then hand it over to So, Ari, as I mentioned, Subravo, GTN was in the low 80 range for Q2. We expected to remain high for the back half of the year. As Ari shared, you know, MBRX is out of the game. We're making sure patients receive product. 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, MBRX to TRX, we would expect GTN to also remain high.

Yeah, and related to some of the color from the clinicians and patients, I think first and foremost, the fact that Sembravo offers a multi-mechanistic approach to acute migraine treatment is very compelling. Most other products are only focusing on one particular pathway. Simbravo is focusing on two 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, you know, what we're hearing early on is, you know, partial tryptan responders, you know, folks who, you know, are getting some relief but not feeling totally better or lacking in pain freedom is a key patient type that Sembravo has been used for. And also, you know, patients that have had good response to a Triptan-NZ combo, but 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 is still very early in 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 position Cibravo as a great option. Thank you.

Thank you. Next question today is coming in from Mark Goodman from Learing Partners. Your line is now live.

Eric, can you talk about your strategy for this precision medicine approach to ADHD, and does that carry over into the adolescents as well as the adults, and how do you plan to move forward with this?

Thanks for the question, Mark. So, the precision medicine approach that we refer to relates to solar amputal for major depressive disorder. And we know that there 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 sleep quality and either some patients either experience excessive sleepiness and others might experience insomnia. 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 the other part of your question on adhd so there we do know that that there is a a continuum of of of the disease from when patients have it as children into adulthood. So, we've 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 adolescents.

Thank you. Next question is coming in from David M. Sullen from Pepper Stanley. Your line is now live.

Thanks. On Ovelity and MDD, can you talk to the mix between second and third line usage and even the extent to which you're getting front line 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 more a better target, a broader audience of general practitioners? How are you thinking about that? Thank you.

Yeah, thanks for the questions. You know, we saw continued stability in terms of early line usage for all validity at approximately 50%. Really no change. It's sort of the second, third line dynamic. And, you know, we're comfortable with that. I think we've shared previously that One of the benefits of availability is that it has strong effectiveness regardless of prior treatment experience. That said, as access improves in utilization management, 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, you know, the TRXs over the course of the year. So, I think we're comfortable with where we are right now, and, you know, we'll continue to monitor the market dynamics to evaluate for the future.

Thanks.

Thank you. Next question today is coming from Serena Chen from Wells Fargo. Your line is now live.

Great. Thanks for taking my question. I had a question on AX05 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? Thank you.

Hi, Serena. Good morning. We had announced earlier this spring our pre-NVA meeting minutes. where we align 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.

Okay, thanks. Thank you. Next question is coming from Andrew Sy from Jefferies. Your line is now live.

Hey, guys. This is John on for Andrew. Thanks for taking the question. So, if we fast forward in nine to 12 months or so, how are you thinking about the commercial strategy for AXS05 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 outcome based on your prior FDA discussions, what would be the key talking points that the FDA would want to discuss in your view?

Yeah, I'll start with the commercial strategy question. Yeah, it's a little early to share too many details, but obviously we track 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. You know, the, the, 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 SI or highest value prescribers within a particular space. And I expect that that would be maintained for an ADA launch.

And then with respect to a potential advisory committee, you know, we've not received any indication that the FDA is looking to hold one. However, that's always something they notify you upon potential acceptance of a filing. And As a reminder, there was not one held for OVALIDI and MDD, and the psychiatry division did hold one for the product that they, for Rex-ULTI, and the indication where they talked about a number of things, endpoints, the scale used, which is the same scale that we use, et cetera. So it's really hard to speculate, but again, we're not aware of one at this time and haven't received communication of such. But if there were one to occur, we'd be ready for it.

Great. Thank you so much. Thank you. Next question today is coming from June Lee from Truist Securities. Your line is now live.

Congrats on the quarter, and thanks for taking the question. This is Austin Rana on for June. Just on smoking cessation, so bupropion is already approved for smoking cessation. Are there any plans to conduct a head-to-head study of AXS05 against warbugin? Thank you.

Thanks for the question. So, AXS05 does combine two actives, and therefore, in order for the product to be approved, there does need to be demonstration of component contribution. So, by definition, a registration study would involve a Bupropion arm.

Thank you. And then, can you just remind us on the Salesforce split across the three commercialized products?

Yeah. So, we have, you know, three distinct sales forces for each product. And, you know, approximately 300 representatives on ability and approximately 100 each for Synosy and Symbravo.

Thank you. Thank you. Our next question today is coming from Yatim Seneja from Guggenheim Partners. Your line is now live.

Hey, guys. Thank you for taking my questions. Very nice quarter. Just a question on... on orality and the MDD dynamic. I mean, obviously you have DTC ongoing. There is sales for 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 during these two dynamics? And if you can also comment on the duration that you're seeing in the marketplace, Kate.

I missed the last part, but duration. Okay, thanks so much. Yeah, so in terms of all-value MDD, obviously we're very pleased with the performance so far this year. One correction I'll make is, you know, although we we have not launched a national VPC campaign. We are expecting to later this year, but that is not currently reflected in our demand trends. So just want to make sure you're aware of that. In terms of the inflection regarding Salesforce expansion, as I mentioned, we began to see an inflection in new patient starts towards the end of Q1 and 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 launch DTC, we expect that to be incremental growth. to the current trend. But in terms of giving you a specific estimate in terms of step change, I think it's a little too premature, particularly because, you know, we're announcing this access when starting in July, you can imagine that the totality of Salesforce expansion, improved access, and then DTC later this year will provide incremental growth rate for brands. In terms of duration, we're seeing somewhere around six, six and seven 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 inadequate response or drop out of treatment based on achieving remission. But on average, it's somewhere around six or seven.

Thank you. Next question today is coming from Joseph Tomey from TD Cal, and your line is now live.

Hi there. Good morning. Thank you for taking my question, and 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 seemed that the presenting KOL at your analyst day had some opinions 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 psilocybin will be active in pediatric patients? And then tangentially, this trial seems to have taken a little bit of time to get off the ground. I guess how confident are you in that Q4 guidance? And is there anything specific about the pediatric population versus adults in terms of IRB timing or anything like that that makes this a little bit more challenging? Thank you.

Great. Thanks for the question. As it relates to the pediatric study, we anticipate that 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'd be using a pediatric scale as opposed to the adult study, which is adult scale. And in terms of what gives us confidence that the adult data will translate into pediatric data, well, you know, we're conducting clinical trials in order to test hypotheses, so nothing is guaranteed. 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, you know, biologically, that would make sense since adult patients must have been diagnosed with ADHD as children. That's part of the diagnostic criteria. And as it relates to the timing of the start of the study. 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.

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

Hey, guys. Thanks so much for taking the question. 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 Synose? And how do you think about your overall strategy in narcolepsy with both Synose and AXS-12, especially as you think about competitive dynamics in polypharmacy? Really appreciate it.

Yeah, thanks so much for the question. You know, there's near perfect overlap in terms of the targets for ICSIS-12 and CINOSI, and so we'll be able to leverage our current CINOSI team fully for an ICSIS-12 launch. So it's a real synergistic opportunity for us as a company. As it relates to physician use, I mentioned my earlier comments. We see a lot of polypharmacy in the space as clinicians Seek to optimize treatment based on the unique sentimentology that patients present with. Um, I think, you know, in some ways, the fact that just 12. And so notice he will have distinct indications. Um, 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, you know, based on final label, et cetera. But we feel very optimistic and, you know, 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.

That's helpful.

Thanks so much. Thank you. Next question is coming from Greg Subanezes from Mizuho Securities. Your line is now live.

Hey, good morning. Thank you for taking my questions. 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? 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 ability and kind of what your current thinking is around timing of when ability might be for such negotiations or discussions. Thanks.

Yeah, I'll start with the seasonality question. So there is summer seasonality really across all three of the markets that we're currently in. I think in some ways depression is perhaps the most pronounced. Obviously, we expect what's in Bravo because it's early in launch that you may not observe a true seasonality effect as the brand is growing from a relatively low base. But there is some seasonality effect in the summer months, you know, cross migraine, EDS, and depression.

Yeah, and then as for Avelity, and you mentioned IRA pricing, it's presumably related to ADA. Again, ADA will be priced at the same WAC price as Avelity. Since it is Avelity, it's $1177 of 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.

Thank you.

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

Hey, this is Sam for David. Thanks for taking the question. On Synozy, anything you all would highlight on 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 ability, Do you feel the need to further increase covered commercial labs from here? Thanks.

Yes, thanks, Sam, for the questions. Regarding FENOSI, 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 prescribing more CINOSI than in previous quarters. So I think this really reinforces our strategy to drive depth of prescribing within the existing EDS marketplace for ACPs. And I apologize for the commercial lives. Yeah. So on the commercial lives, obviously, we're very pleased with the announcement for today. But, you know, we're at 83% covered lives in total. And, you know, 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.

Great, thank you.

Thank you. Our final question today is coming from Miles Minter from William & Blair. Your line is now live.

Hi, guys. Thanks for squishing me in. Just one on Synosyn ADHD and the comment to receive perfect alignment with the regulators. I'm curious as to why you think you know, sufficient for potential approval here, as opposed to the guidance, which keeps kind of bringing up the two positive pediatric studies, one of which could be done in adolescence, would be required for approval here. Just wondering whether you've received alignment with the agency based on that. Thanks very much.

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 1 can. Adequately determine, you know, what dose will be effective in both of those patient. Subpopulations, so there is a, 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 as streamlined a fashion as possible.

Thank you.

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

Thank you all for joining us today. As you've heard on today's call, Axel delivers 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.