AXSM

Good morning, welcome to the Axsome Therapeutics first quarter 2026 earnings conference call. My name is Kevin. I'll be your operator for today's call. At this time, all participants are in listen-only mode. Later, there'll be a question-and-answer session, and instructions will be given at that time. Please note this call is being recorded. I will now turn the call over to Ashley Dong, Senior Director of Investor Relations. Ashley, please go ahead.

Thank you. Good morning, and thank you for joining Axsome's 1st quarter 2026 earnings conference call. With us 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 also be available for Q&A. Please note that today's discussion includes forward-looking statements regarding our financial performance, commercial strategies, and operational plans, including research, development, and regulatory activities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our SEC filings, including our quarterly and annual reports, for a description of these and other risks.

You are cautioned not to rely on these forward-looking statements, which are made only as of today, and the company disclaims any obligation to update such statements. With that, I'll hand it over to Herriot.

Thank you, Ashley, good morning, everyone. In the first quarter of 2026, Axsome delivered strong year-over-year growth and execution across the business. This performance was driven by our commercial products and the advancement and expansion of our R&D pipeline, which is now composed of six innovative, potentially first-in-class or best-in-class product candidates. Starting with our commercial business, total revenue for our three marketed products was $191 million, representing year-over-year growth of 57%, driven by AUVELITY and SUNOSI with contribution from SYMBRAVO. Building on the strong clinical profile of our marketed products, in the quarter, we substantially expanded the sales force for AUVELITY, finalized plans for the expansion of the SYMBRAVO sales force, and increased covered lives and quality of coverage for all of our marketed products. These initiatives will support continued strong revenue growth of the base business this year and beyond.

Last week, we received FDA approval of AUVELITY for the treatment of agitation associated with Alzheimer's disease, an indication which received FDA breakthrough therapy designation and priority review. This approval introduces a first-in-class treatment option for this highly prevalent, debilitating, and critically underserved neuropsychiatric condition. It marks an important milestone for the millions of patients living with Alzheimer's disease, their families, and their caregivers. AUVELITY has now been approved in two indications that received FDA breakthrough therapy designation and were granted FDA priority review. The approval in Alzheimer's disease agitation, combined with the health of the MDD business and the recent augmentation of the AUVELITY commercial infrastructure, provide us with a clear line of sight to AUVELITY's market potential. Ari will provide an update to our peak sales estimate for the AUVELITY franchise based on these developments.

The approval in Alzheimer's disease agitation is a testament to our research and development productivity. Since the start of this year, we have continued to advance and expand the rest of our industry-leading pipeline with a focus on developing first-in-class and best-in-class products. On the regulatory front, following the FDA approval of AUVELITY last week, we are pleased to share that we have submitted our NDA for AXS-12 for the treatment of cataplexy and narcolepsy. Clinically, our ongoing trials continue to progress, and we will be starting multiple phase III trials within the next few months. We recently expanded our pipeline further with the addition of AXS-20, a potentially first-in-class pre-phase III PDE10A inhibitor for schizophrenia and Tourette syndrome. I will discuss each of these developments in detail later in the call.

All in all, Axsome is advancing the commercialization of three differentiated marketed medicines across four highly prevalent indications, as well as an innovative pipeline of potentially first-in-class and best-in-class medicines that includes six product candidates targeting 10 different highly burdensome conditions in psychiatry and neurology. Looking ahead, Axsome is well positioned to realize robust growth driven by execution across our commercial portfolio for long-term AUVELITY in Alzheimer's disease agitation and the advancement of the rest of our neuroscience pipeline. With that, I'll hand the call over to Nick to review our financial results for the quarter.

Thanks, Herriot, and good morning, everyone. Our financial performance in the first quarter was strong, with our three commercial products delivering continued double-digit revenue growth. Total revenue for the quarter was $191.2 million, a 57% increase compared to the first quarter of 2025. We expect revenue growth to continue in 2026. AUVELITY achieved net product revenue of $153.2 million in the quarter, up 59% compared to the first quarter of 2025. SUNOSI net product revenue for the quarter was $33.9 million, a 34% increase compared to the first quarter of 2025. SUNOSI revenue consisted of $32.6 million in net product sales and $1.3 million in royalty revenue associated with SUNOSI sales in out-licensed territories.

Net sales for SYMBRAVO were $4.1 million in the quarter. AUVELITY and SUNOSI gross-to-net discounts for the first quarter of 2026 were both in the low to mid-50s range. We anticipate the gross-to-net discounts for both products to improve throughout the year, consistent with prior year trends. SYMBRAVO gross-to-net discount for the quarter was in the high 70% range, and we continue to expect it to remain elevated over the near term as access continues to evolve and awareness continues to build. Turning now to expenses. Total cost of revenue were $14.7 million compared to $9.8 million for the first quarter of 2025. Our research and development expenses were $52.7 million in the quarter, compared to $44.8 million for the first quarter of 2025.

The increase in R&D spend primarily reflects a one-time acquisition-related expense booked in the quarter. Our selling, general and administrative expenses were $185 million for the quarter, compared to $120.8 million for the first quarter of 2025. The increase was primarily driven by the acceleration of pre-launch activities for AUVELITY in Alzheimer's disease agitation and commercialization activities for AUVELITY, which included the national direct-to-consumer advertising campaign and sales force expansion, along with commercial activities for SYMBRAVO. Net loss for the quarter was $64.5 million or $1.26 per share, compared to a net loss of $59.4 million or $1.22 per share for the first quarter of 2025.

The $64.5 million net loss in the quarter includes $23.4 million in stock-based compensation expense. Our balance sheet remains strong. We ended the first quarter with $305 million in cash and cash equivalents, compared to $323 million as of the end of last year. Our overall financial performance reflects continued top line revenue growth and improving operating leverage driven by disciplined commercial execution. We anticipate that our current cash balance is sufficient to fund our operations into cash flow positivity based on our current operating plan. With that, I'd like to turn the call over now to Ari, who will provide additional details on the key drivers behind our medicines and the broader commercial performance of the business.

Thank you, Nick. The first quarter of 2026 was a pivotal period for Axsome's brands, reflected in ongoing demand for our medicines, meaningful improvements in payer coverage and sales force expansion activities. Our promotional efforts across HCP and patient audiences, combined with a broadening commercial infrastructure, will support Axsome's sales objectives throughout 2026. Starting with AUVELITY, more than 223,000 prescriptions were written in the quarter, representing 35% year-over-year growth and remaining consistent with the prior quarter. By comparison, the antidepressant market grew 1% year-over-year and declined by 1% compared to Q4 2025. AUVELITY performance in the quarter was highlighted by a continued shift toward earlier line use, with first line/first switch prescriptions increasing to 56% of overall demand. Primary care adoption also expanded in the quarter, now representing 35% of total AUVELITY prescribers.

These trends reflect meaningful improvements in market access over the last two years, broadened awareness of the brand driven by our national direct-to-consumer campaign and our concentrated effort in expanding use among primary care providers, a key driver of earlier line utilization and an important foundation to support early trial in connection with the upcoming Alzheimer's disease agitation launch. Additionally, more than 5,500 new prescribers were activated in the quarter, bringing the total number of unique prescribers for AUVELITY since launch to approximately 60,000. We continue to make important progress with formulary access for AUVELITY. Commercial coverage is at 78% and alongside Medicare and Medicaid coverage at 100%, total coverage is now at 86% of all lives across channels, establishing a strong foundation of access for AUVELITY in advance of the launch in Alzheimer's disease agitation.

We expect both the quantity and quality of coverage to continue to expand and improve. AUVELITY's growth to date in the depression market continues to reflect its compelling clinical profile, highlighted by rapid and durable symptom improvement and a distinctly favorable safety and tolerability profile. Last week's FDA approval of AUVELITY as a treatment for agitation associated with dementia due to Alzheimer's disease is a significant advancement for patients and a major milestone for the brand. We are very pleased with the product label, which provides compelling clinical information regarding AUVELITY's impact on agitation for Alzheimer's patients. AUVELITY is a first-in-class treatment for this patient population, demonstrating rapid and durable symptom improvement with a favorable safety and tolerability profile. AUVELITY is the only approved treatment for Alzheimer's disease agitation with efficacy on symptom relapse demonstrated in long-term trials.

In a short-term study, the most common adverse reactions were dizziness and dyspepsia. Only 1.3% of patients discontinued treatment due to an adverse reaction, the same rate as placebo. In market research, HCPs rate AUVELITY's clinical profile on Alzheimer's disease agitation as highly compelling from both an efficacy and safety perspective, with clear potential for first-line use in appropriate patients. We are expanding the AUVELITY sales team to approximately 630 representatives, enabling Axsome to reach 68,000 HCP targets across primary care, psychiatry, neurology, and geriatric specialists who treat both MDD and Alzheimer's agitation patients across community and long-term care settings. Our expansion efforts are substantially complete, positioning us well for the commercial launch in June.

We believe AUVELITY has the potential to play a significant role in the treatment of Alzheimer's disease agitation and together with the MDD indication, further broadens its use across serious neuropsychiatric conditions. AUVELITY's expanded sales force and strong foundation of coverage position the brand to drive growth across both indications throughout the second half of 2026. Taking into account the recent label expansion in Alzheimer's disease agitation, the clinical profile in this indication, the health and trajectory of the MDD business, and recent investments in our sales infrastructure, we are now able to update our peak sales outlook for the product. We now believe AUVELITY has the potential to generate at least $8 billion in annual revenue at peak, with approximately equal contribution from each indication.

Over the extended life of the product, we see a clear path to achieving this growth potential, supported by the underlying fundamentals of the business as we continue to scale. Turning now to SYMBRAVO. More than 17,000 total prescriptions were written in the quarter, representing 36% growth versus Q4 2025. More than 5,000 new patients started SYMBRAVO treatment in the quarter. Neurology specialists accounted for approximately 60% of total writers in the quarter, with primary care representing approximately 32%, an increase from 20% in the 1st quarter of launch. While headache specialists will remain a critical prescriber segment for SYMBRAVO, the increase in primary care prescribing is an encouraging signal of SYMBRAVO's potential and reinforces the early experience with SYMBRAVO as a safe and tolerable acute migraine treatment that provides fast migraine pain improvement sustained through 24 and 48 hours.

Based on SYMBRAVO's growth within its launch year and increasing demand for education of the only branded multi-mechanistic acute migraine treatment in the market, we are increasing the SYMBRAVO sales team by approximately 50 representatives. Our expanded SYMBRAVO sales force of 150 representatives will support broader reach in the primary care market while deepening engagement with headache specialists and neurologists throughout the country. We are also pleased to announce a major commercial payer contract for SYMBRAVO effective this month, securing coverage for approximately 17 million lives. The agreement reflects SYMBRAVO's compelling clinical profile and its potential to address the needs of patients with inadequate response to triptans. Overall payer coverage for SYMBRAVO is approximately 57%, representing 56% in the commercial channel and 57% in government channels. We expect coverage for SYMBRAVO to expand and evolve throughout 2026.

Finally, in Q1, approximately 54,000 SUNOSI prescriptions were written, representing 16% year-over-year growth and a 3% decline sequentially. By comparison, the wake-promoting agent market grew 1% year-over-year and declined by 5% versus Q4 2025. Nearly 500 new clinicians prescribed SUNOSI in the quarter, bringing the total cumulative prescriber base to more than 16,500 since launch. Payer coverage for SUNOSI remains steady at approximately 83% of lives covered across channels. Overall, the first quarter of 2026 was marked by significant progress across Axsome's commercial business, including strong demand for our products, key advancements in market access, launch preparations for AUVELITY and Alzheimer's disease agitation, and disciplined organizational growth designed to maximize the potential of our singular CNS portfolio. Looking ahead, Axsome is well positioned to deliver on our commercial objectives across our innovative portfolio through the balance of the year.

We look forward to sharing our continued progress with you over the coming months. I will now turn the call back to Herriot to discuss our singular CNS pipeline.

Thank you, Ari. I will now touch on recent developments and upcoming milestones for the rest of our pipeline. Starting with AXS-12, as I mentioned, we recently submitted our NDA for AXS-12 for the treatment of cataplexy in patients with narcolepsy. Narcolepsy is a rare and debilitating neurological condition that affects approximately 185,000 people in the U.S. We are excited by the potential of AXS-12 to provide a new and differentiated treatment option to patients living with narcolepsy. We look forward to announcing the FDA's decision on the acceptance of the filing. Beyond AXS-12 in narcolepsy, we are also developing the full suite of clinical programs in our leading neuroscience pipeline. Starting with AXS-05, we are on track to initiate a pivotal phase II/III trial in smoking cessation this quarter. Moving on to solriamfetol. Our phase III programs for this molecule continue to progress.

These include ADHD, binge eating disorder, MDD with symptoms of excessive daytime sleepiness, and excessive sleepiness in shift work disorder. For ADHD, we are on track to initiate two pediatric phase III trials, one in children and one in adolescents this quarter. For MDD, we recently initiated the CLARITY study, a phase III double-blind, placebo-controlled, randomized withdrawal trial. In the trial, patients who achieve a sustained response during the open label period will be randomized to continue solriamfetol or switch to placebo. The primary endpoint of that trial is time to relapse of depressive symptoms. For binge eating disorder, our ENGAGE phase III double-blind, randomized controlled trial is progressing, and we anticipate top line results in the second half of this year. Finally, for shift work disorder, the phase III trial continues to enroll, with top line results anticipated in 2027.

Turning now to AXS-14, our novel, highly selective and potent norepinephrine reuptake inhibitor for fibromyalgia. Enrollment is ongoing in the FORWARD phase III trials. We look forward to sharing updates on this program as the study progresses. For AXS-17, our novel oral selective gabapentin for epilepsy tech transfer and phase II trial enabling activities are well underway. Lastly, we recently acquired AXS-20, or balipodect, a potentially first in class oral potent selective PDE10A inhibitor. We plan to develop AXS-20 for the treatment of schizophrenia and for Tourette syndrome. We plan to initiate phase III trial enabling activities for AXS-20 in schizophrenia later this year. I will now turn the call back to Ashley for Q&A.

Thank you, Herriot. Operator, please open the line for Q&A.

Certainly. We'll now be conducting a question and answer session. In the interest of time, we ask you please ask one question and one follow-up, then return to the queue. Our first question today is coming from Ashwani Verma from UBS. Your line is now live.

Hey, guys. Congratulations again on all the progress. Thanks for taking our question. I know it's the second day of Q&A, but maybe just on ADA, are you thinking about the LTC market in the long run? I mean, clearly right now, 40% of these patients reside in LTC, but the current prescriber mix is heavily PCP. When you think about the long run, for this, for you to completely extract value out of this market, how much of a focus does LTC need to become in the long run? Thanks.

Hi, Ash. Thanks for the question. It's Ari. Our sales team of approximately 630 representatives will call on both community and long-term care facilities. For us it's important to be present and to educate prescribers and care partners within both facilities or both settings of care. Ultimately, it's a concentrated market that allows for efficient promotional activities. We expect that it will grow over time as the brand ramps. We believe that community and long-term care are both very important for this market and look forward to sharing some updates as we get going with the launch.

Got it. Can I ask a quick follow-up?

Sure.

Just on the ADA indication, I know you're using this unique 30mg dextromethorphan dose in the titration pack, which you haven't used before for this launch. Is this supplied in the channels already or does this in any way become like a bottleneck for the full launch at this point? Thanks.

Hi, Ash. As a reminder, we'll be launching next month. Ari touched on the items that are being finalized right now for launch. Do you wanna recap those again one more time, Ari?

I mean, we're finalizing our sales and marketing resources and training our sales force on the new indication. The titration dose will be available at the time of commercial launch.

Thanks.

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

Those are pretty big peak sales numbers. Can you help us just understand, like, why did you feel like you had to raise them today? Secondly, just talk about what went into the forecasting there and, $4 billion in each indication. Thank you.

Thanks, Mark. The FDA approval of AUVELITY in Alzheimer's disease agitation provides greater certainty regarding the long-term sales potential of the product. As you know, Alzheimer's disease is a large and growing market. 7 million patients, of which 76% are impacted by agitation symptoms. Of course, there are only two approved agents on the market. When we review our proprietary market research on HCP perceptions, potential use of the product, taken together with the clarity around the final label, it really provides confidence that AUVELITY will be used as a frontline treatment in Alzheimer's agitation. We've seen growing use as frontline treatment in MDD.

The foundation market access that we built, along with growing adoption in primary care, which of course is a critical provider segment in the Alzheimer's space, I think these things, taken together with our MDD penetration and growth trajectory and the increased sales force to support both indications, give us confidence in the potential to achieve our updated peak sales estimate for AUVELITY.

Thank you.

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

Hi, good morning. Thanks for taking our questions. I had a bigger picture question. You know, now with AUVELITY approving Alzheimer's disease agitation, how does that embolden you guys to pursue even more indications? I'd imagine you can directly go to phase III with AUVELITY for other indications. This drug has a long tail, too. Maybe talk about when we might learn more about indication expansion of opportunities, or is that it with AUVELITY? Thanks.

Hey, Andrew. Good morning. The we did touch on the next indication that we've been working on for some, that smoking cessation. Stay tuned for updates there. You know, the next step with that program is initiating the phase II/III pivotal trial. We'll have updates there soon. You know, the product is very interesting given that it targets the NMDA and sigma-1 receptors. High potential applicability to other neuropsychiatric conditions, you know, that's something that the team is obviously exploring. Right now, the next formal step is smoking cessation trial initiation.

Great. As a follow-up, with your new PDE10 asset that's starting phase III enabling studies this year, can you talk about the efficacy safety profile, why it did not necessarily hit stats sig in phase II, and why you think you can produce a different outcome in phase III? Correct me if I'm wrong, but I think schizophrenia studies could be relatively fast. Could it be possible we get data maybe 2028? Thanks.

Sure. Thanks, Andrew, for the question on balipodect. With regards to the efficacy, there was a phase II trial, which you mentioned, which was done in schizophrenia. This was a randomized double-blind, controlled trial. When we looked at the data, there was clear separation. The magnitude of treatment effect for balipodect was on the high end when you look at historical treatments for schizophrenia. Now, because of the size of the study, obviously it was not powered for statistical significance. Despite that, there was a very clear trend and there was statistical significance on various measures, including, for example, global measures. Clinicians were able to see the highly statistically significant improvements in schizophrenia. There were also other measures which were positive.

For example, the rates of discontinuations due to lack of efficacy, wide gap with half of the patients who were placebo discontinuance to lack of efficacy versus in the low double digits for balipodect. Clearly, there was a very strong signal there. When you look at the safety profile, it is very distinct obviously from atypical antipsychotics. We're very excited about this potentially first-in-class treatment. As it relates to timing of starting a phase III trial, this is a phase III-ready asset. What we need to do is to restart manufacturing of clinical supplies. The phase III-enabling activities are ongoing this year.

We would anticipate we are targeting potentially starting a phase III trial around the end of the year.

Thank you again. Big congratulations.

Thank you. Next question is coming from Ami Fadia from Needham & Company.

Hi. Good morning. Thanks for taking my question. Firstly on SYMBRAVO, can you give us some more details around where you're seeing utilization and how you see the drug evolve, you know, with sort of this expanding payer coverage? How do you see the evolution of, you know, gross to net and also utilization as the year progresses? With regards to AUVELITY, just to follow up to a previous comment, as you think about the IP runway you have, how are you thinking about sort of really expanding the number of indications where you explore this product, you know, ahead of the IP runway and the IRA? You know, could we expect to see you look at multiple other indications, or will it be sort of more sequential? Thank you.

Hey, Ami. I'll start with the SYMBRAVO question. You know, we've been really pleased that SYMBRAVO has found its way into the treatment paradigm for many headache specialists. What we're seeing is, you know, approximately 60% of use is in the first and second line setting. The feedback that we get from HCPs is that SYMBRAVO has been particularly effective for patients with inadequate or partial response to triptans, we expect those patients to be the primary focus moving forward. Obviously the market access win that we're announcing today is an important step for long-term patient access. We think it will have a positive impact on GTN in the future.

The focus of the team is to continue to expand access for patients, which will help to drive reductions in GTN over time. For the short term, we expect GTN to continue to be elevated as we build our access.

Great. As it relates to sort of a question on new indications or additional indications for AUVELITY given the IP runway, you are correct. We're in a very favorable position given that there is a very long exclusivity runway for AUVELITY and also the fact that the product is commercialized. We are not resource constrained as it relates to potentially developing it for other indications. The other interesting thing about the product which Warren touched upon is its unique pharmacology, which is applicable to a number of potential CNS indications. We have very clear ideas, as you can imagine, internally around what these additional indications are. We want to make sure that we move in a very measured way.

If there is something that is worth doing, you know, we think it's worth doing quickly. Stay tuned as it relates to other potential indications which could further increase the value of the product long term.

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. another follow-up question on the PDE10. My understanding was that I think Axsome in acquiring this asset planned to push dose relative to what was studied by Takeda to get better receptor occupancy. Wondering if you can speak to that dynamic, how high you'd be looking to push dose and confidence that the supportive data give you a safe dose strength to interrogate. As my follow-up, are there any signs or indications that, you know, antipsychotic use in nursing homes is coming down at all in the wake of the March OIG report that was dubbed, I think, Inappropriate Use of Antipsychotics in Nursing Homes?

Just kind of curious if you have any insights, as you gear up for your own, ADA launch. Thanks.

Yeah. Thanks for the question. With regards to the PDE10 inhibitor, we have not discussed dosing as it relates to the product. However, the dose that was studied was effective. You know, had the number of subjects per arm than what you would have what you would have seen in a normal phase III trial in schizophrenia. Clearly it would have reached the level of significance.

Yeah. Regarding your question on antipsychotic use, there hasn't been an immediate drop in antipsychotics in an overall substantial way. I think the news is still relatively new. What I will say is that the awareness of that report and the sensitivity on using antipsychotics with this patient population is very high among providers and family members. We think that provides a good foundation for the AUVELITY launch in the Alzheimer's disease agitation space, and expect there to be, you know, continued focus on antipsychotic use moving forward.

Thank you.

Thank you. Next question today is coming from Ram Selvaraju from H.C. Wainwright. Your line is now live.

Thanks so much for taking my questions. Firstly, on the commercial side, I was wondering if you could provide us with some additional details regarding the deployment of the field sales force, the degree to which sales reps currently promote more than one product, or are dedicated to promoting a single product within your commercial product range, and how you expect this to evolve going forward. In other words, to what extent do you expect to deploy sales representatives dedicated to a specific product and a specific indication, versus having them promote more than one product at a time? To what extent, you know, this strategy will be reflective going forward, in the deployment of the commercial sales force.

With respect to clinical development directions, I was wondering if you could comment generally perhaps on your interest in muscarinic receptor modulation, particularly as this pertains to both the neuropsychiatric and cognitive dysfunction dementia fields. You could also give us a sense with respect to balipodect, you know, where you expect the specific safety advantages of this, of this product to lie within the neuropsychiatric indications that you expect to target. Thank you.

Yeah. I'll start with the deployment of sales force question. Up to this point, we've largely had our sales teams focused on one specific brand. Part of that is related to the unique specialist audiences that are particularly important in the launch phase. For AUVELITY, that's psychiatry, for SYMBRAVO, headache specialists and neurologists, and for SUNOSI, sleep specialists. With the Alzheimer's agitation launch, because of the high degree of overlap in call points for MDD and ADA, that team will be supporting and promoting both indications. But in terms of long-term potential or vision for the team, as you know, our portfolio and our pipeline is unique in that there are many shared call points for certain therapeutic areas.

That's something we'll continue to evaluate, and we'll share as we make some progress moving forward.

Great.

As it relates to the pipeline questions, with regards to your question on muscarinic receptor modulation, that mechanism of action does not fall into our current pipeline, so we don't have much to add there. As it relates to balipodect and the potential safety advantages, just as a reminder, this is a PDE10A inhibitor. It works by regulating cyclic AMP and cyclic GMP levels downstream from D1 and D2 receptors. The potential safety advantage, and this has been shown in preclinical studies as well as in clinical studies, is one of the advantages is that what has not been seen or changes in glucose levels or prolactin levels.

As you know, with atypical antipsychotics, one of the major side effects has to do with metabolic side effects. We have seen pre-clinically as well as clinically that this could be a major benefit with balipodect.

Thank you.

Thank you. Next question is coming from David Amsellem from Piper Sandler. Your line is now live.

Thanks. Just two for me. With the significant expansion of the commercial infrastructure, what's your appetite for the acquisition of a market ready or commercial stage asset? I know you focused on expanding the pipeline, but you have a lot of infrastructure now that you can leverage. Maybe talk to that. Secondly, a question on reboxetine and how you're thinking about the underlying commercial opportunity in a landscape where you're going to have orexin two receptor agonist as options in this population. Thanks.

In terms of being able to acquire a marketed product, we have done that in the past, and we did that with SUNOSI, which was our first acquisition. Having said that, we have such a rich portfolio of marketed assets, new indications and also a very late stage pipeline that we, you know, we have enough to focus on to drive long term and as well as near term value. Short term and near term value questions and, you know, long term sustainable value creation. With regards to the orexin two agonist. If you look at if you look at narcolepsy, this is an orphan indication, but a large orphan, 185,000 patients.

What we see is that there's a lot of heterogeneity in this patient population. There's a lot of polypharmacy. Not every drug works. Also there is a lot of side effect liability with the current treatments. You know, each treatment will have different side effect profiles. What we like about our product, about AXS-12, a couple of things. One, it works very quickly. We have an onset of action which is at one week. Currently, all the other products on the market take a lot longer, about 1 month to work. Secondly, the efficacy that we've seen is durable. We have data out to 6 months.

And all of that efficacy comes with a very favorable side effect profile and a first-in-class mechanism of action for narcolepsy. Lastly, with regards to some of the other ancillary symptoms of narcolepsy, the data does show that AXS-12 has the potential to also beneficially affect EDS as well as cognition. We're very excited by the potential to provide a new treatment option to patients.

Thank you.

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

Hey, guys. Thank you for taking my questions and congrats on all the success and progress. Just a question on ADA. Actually two questions. One is, you know, how should we think about sort of guidance? At what point do you think you might be able to establish guidance if that's even possible? Two, you know, if we, you know, we are all trying to model the ADA ramp curve. Obviously when you launch AUVELITY in MDD, I think the awareness was not there. How much more like how should we think about the early launch in MDD and how do we sort of model it for ADA? Any guidance there will be really helpful. Thank you.

Sure. Hey, Yatin, this is Nick. As it relates to guidance, first of all, we gave guidance, right? We have peak sales guidance out there of at least $8 billion for AUVELITY, $300 million-$500 million for SUNOSI, and $500 million-$1 billion for SYMBRAVO. That's our peak sales guidance. You know, obviously a lot of fluidity now with the expansion, with the approval, with market access continuing to grow and evolve. At this point, there's many variables out there from a short-term perspective. We want to see how they evolve and then we can take a look at potential guidance down the road.

Regarding the ADA ramp, obviously it's very challenging to predict exactly how any new launch will ramp over time. As you mentioned, you know, the AUVELITY MDD in one hand is an analog, even though different marketplace, same product and, you know, obviously we're optimistic because there's greater awareness, better market access, larger sales team. On the other hand, there's a one analog in this market with Rexulti, and although the clinical profiles are very different, it does give some sense of uptake in the settings of care which we'll be entering. I think we'll learn more as we get into the launch, and we'll be able to share those details of what we're observing.

Thank you.

Thank you. Next question is coming from Sean Laaman from Morgan Stanley. Your line is now live.

Thank you. Good morning, everyone, and hope everyone's well. Back on AXS-12, I'm just wondering what you sort of price and payer discussions, if any, have been like, and what's the kind of investment you think you need to make to ensure that this drug has a success, you know, given there is, you know, such hot debate on the OX2R agonist and the large market potential there?

Thanks, Sean, for the question. You know, obviously, we've been engaged with payers on early education around the clinical trial programs and the data. We have not specifically engaged in pricing discussions, so I'll have to defer to a later time to share some of those details. There is genuine interest in new narcolepsy products for the reasons Ari stated earlier, which is that there's significant inadequate response, treatment switching and polypharmacy. Payers are very mindful of ensuring that treatment options that are available have strong efficacy, safety, tolerability. In terms of the investment required, you know, we'll have more to share as we get closer to a potential approval.

As we've mentioned previously, you know, we have established a sleep team for SUNOSI that is in market today, and obviously there is near perfect overlap in terms of ACV targets for SUNOSI and AXS-12, if approved.

Yeah, maybe just a little bit furthering on to Ari's comments from a financial perspective. You would think of orphan drug pricing from a top line. As Ari shared, we already have the infrastructure set up with the sleep team and the marketing team from sleep. You know, what we would anticipate that a lot of synergies with AXS-12 into the current infrastructure and continued improved operating leverage within the P&L.

Well, thank you. How excited are you about that product? It doesn't seem to get a whole heap of airplay amongst investor discussions. How excited are you about it?

Dario? Oh, I'm sorry. Go ahead. Very excited. We are very excited. The feedback we're getting from KOLs and early market research is really strong. You know, because these patients are very difficult to treat and are frankly dissatisfied with existing treatment options, we believe there will be significant room for AXS-12 to make a significant impact in this marketplace.

Wonderful. Thank you. That's all I have.

Thank you. Next question today is coming from David Hong from Deutsche Bank.

Hi there. Thanks for taking my question, and congrats on all the recent progress. First I wanted to come back to the peak sales number that you put out there for AUVELITY. If I, if I heard you correctly, I think you said 50/50 for the, you know, MDD versus ADA indications. The MDD number, you know, strikes me as a large one, and I'm just wondering if you look at other, kind of other antidepressants or comparable products in the market to help you get to that number. Maybe a follow-up there is, does that contemplate, you know, evolving competition in the field over the next few years, let's say? For example, do you see psychedelic therapies as competitors to AUVELITY? Thanks a lot.

Thanks, David. I think obviously we take a look at market analogs, but they don't fully drive our decisions, which is largely based on our internal research and analysis, and, you know, what we're seeing in terms of adoption rates, penetration, the improvements in our commercial infrastructure related to sales force and market access, and now the additional data in Alzheimer's disease agitation. In some ways, AUVELITY stands on its own in this marketplace because of its novelty in terms of mechanism of action as well as the clinical profile that it delivers when compared to other treatment options.

We're confident in the potential that we shared earlier today, and, you know, look forward to sharing some additional updates as we grow the brand, particularly as we get into the Alzheimer's disease agitation launch, which is a really important milestone for the brand.

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

Oh, hey. Thanks everyone. Congrats on the quarter. First one's just on the ENGAGE study of solriamfetol in binge eating disorder. How are you thinking about what you'd like to see from an efficacy standpoint there? Should we be looking at the Vyvanse data set of about 1.5 day reduction in binge eating days over that week period, so that'd be about 18 to 20 days over your 12 weeks in ENGAGE? That's the first one. On AXS-14, very curious as to the randomized withdrawal nature of the trial that you're conducting in fibromyalgia. That seems great from a probability of success standpoint. Just reading some recent guidance from the FDA, I think that they make a statement that it's not necessarily a robust comparative from the safety aspects of that drug.

Was there any sort of conversations that you're already over the, you know, over the hurdle per se on the safety data requirements for AXS-14 with the previous data from Pfizer and that you don't have to do any additional studies beyond this one? Thanks very much.

Thanks for the questions. As it relates to the binge eating disorder study, it's hard to say what we're looking for. Obviously, we powered the study to detect a treatment difference. One of the limitations of making predictions is that currently there's only one product that's approved, so not very many studies have been done in binge eating disorder. That's exciting, and we look forward to the data readout to see what we see. Obviously what we're looking for is a positive study. We're looking for a statistically significant improvement with our drug versus placebo. As it relates to AXS-14, we are very excited about the clinical trial which we've launched.

With regards to the safety data, just as a reminder, two randomized double-blind placebo-controlled trials have been conducted and both of those were positive. These were very large studies. There were two long-term safety trials with hundreds of patients treated out to at least one year. Plenty of randomized as well as long-term safety data with AXS-14.

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

Hey, guys. Congrats again on the ADA approval, thanks for taking our question. We were wondering just about your overall BD strategy following the recent deals for AXS-17 and balipodect, especially in terms of additional capacity in other areas you'd like to add to. If the recent policy and regulatory dynamics as well as some strategic interest for those inform your thinking there at all, I really appreciate it.

Thanks for the question. We don't, as you know, comment specifically on business development, but what we can share is that we think very carefully and we're very selective as to what we add. We don't really need to add anything more. We have a pipeline right now which is very deep and very broad and late stage. You know, we did announce these two recent business development transactions which provide us two new NCEs with novel first-in-class mechanisms of action. That complements the rest of our pipeline. You know, we've demonstrated our ability to generate what we believe will be an inflection in the base business already.

Then also we are ensuring that that inflection will be sustained with the current pipeline that we have.

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

Hey, thanks very much. I wanna ask just a question about the Clarity solriamfetol study. So it's a randomized withdrawal study. Maybe give a little color as to why that design was chosen. I guess if it's positive, would you expect to have to do a parallel study after that?

Thanks for the question. We do anticipate that we would need two positive trials. That's the standard for any approval for any indication at the FDA. In terms of the reason for the randomized withdrawal design, one of the challenges with neuropsychiatric indications and depression in particular is the placebo response. How do you deal with that? In the prior studies, in the prior study which we conducted with solriamfetol in this indication, what we saw in the active arm was clearly a very pronounced antidepressant effect. What we wanted to make sure is that we're able to tease out and really demonstrate that this is a drug effect, and while minimizing the impact of the placebo response.

That's the rationale behind the selection of that study design.

Okay. Thank you very much. Can I also ask, just like long term, how are you thinking about profitability? Does the increased conviction in AUVELITY and what that could do from a sales perspective, I guess, does profitability start to become a goal for the company, or is the focus kind of more on sort of revenue growth?

Right now our focus continues to be on revenue growth. I think if you had to put things in priority order, revenue growth is number one, then getting a cash flow positivity is two, and then profitability shortly thereafter.

Great. Thank you.

Thank you. Next question is coming from Graig Suvannavejh from Mizuho. Your line is now live.

Good morning, guys. Congrats on all of the progress and especially the AD agitation approval. Thanks for taking my questions. I've got questions on AUVELITY, and I'm curious if you could provide some color around how we should think about this year's quarterly sequential growth given seasonality dynamics, given that, you know, while AUVELITY is still growing year-over-year in MDD, as you get to bigger numbers it starts slowing down, but then you've got the ADA launch. I guess, do you anticipate year-over-year growth in 2026 to be perhaps bigger than you saw in 2025?

just a follow-up on AUVELITY, just given the Alzheimer's disease agitation approval, can you tell us how you're thinking about IRA implications and how we should think about as you add more Medicare patients, how we should think about including that in our models or not in terms of any impact there? Thanks.

Great. Yeah, I'll start with the first question around quarterly sequencing. You know, we haven't guided specifically on sales ramp over the course of the year, but, as you know, Q1 is a quarter in which market seasonality comes into effect, but we believe is transitory in nature, as evidenced by the early demand trends that we're seeing in Q2.

Maybe just a little bit on the IRA, Greg. You know, at the earliest, IRA negotiations will not impact AUVELITY until 2031. Obviously, assuming AUVELITY meets the requirements for negotiation of being a top spend Part D product. It is important to note that the $8 billion that we shared today contemplates any type of IRA impact.

Okay. Thank you.

Thank you. Next question is coming from Brian Skorney from Baird. Your line is now live.

Hi. Thanks for taking our question. This is Charlie on for Brian. Just kind of following up on an earlier question, curious how you're thinking about positioning SUNOSI ahead of potential orexin agonist launch later this year, as well as with your expansion of the sales force there and wrapping up the expansion of the AUVELITY sales force, how should we think about kind of the ramp of SG&A spend throughout 2026? Thank you.

Maybe I'll take the SG&A question first. SG&A increased this quarter, primarily for four reasons. First off, we typically do see a bit of phasing of higher spend in SG&A in Q1 versus the rest of the year just on the underlying business. Secondly, we accelerated the marketing spend in preparation of approval of ADA to ensure the infrastructure was established and ready to launch in June. We're moving along there very nicely. Thirdly, the field force expansion was actually faster than we anticipated. We're pleased with where we are in preparation for a June launch. Fourth, we actually continue to have DTC spend for AUVELITY in MDD.

As we think about the rest of the year, we would anticipate SG&A will likely increase in Q2, but at a slower rate than what we've seen from Q4 to Q1 and likely level out shortly thereafter. Importantly, we should note that we expect to see continued operating leverage in the P&L as top line revenue growth is anticipated to outpace the growth that we expect to see in operating expenses.

Regarding your question on AXS-12, obviously it's a great time for treatment developments in the narcolepsy space. We're very excited about the potential for AXS-12 to enter this marketplace. You know, without sharing specifics around the orexins, I would just say that we're very pleased with the phase III clinical trial results. Herriot mentioned earlier, you know, significant reduction in weekly cataplexy attacks as early as week one, very safe and tolerable, demonstrated benefits across a variety of secondary endpoints, including excessive daytime sleepiness and in cognition. We think there's a real opportunity for AXS-12 to make a difference for patients. We'll look forward to news regarding the submission.

Great. Thank you very much.

Thank you. Next question today is coming from Madison El-Saadi from B. Riley Securities. Your line is now live.

Hey, congrats on the progress, and thanks for taking our question. A couple related to AUVELITY. Our understanding is that long-term care formulary additions are gated by these quarterly reviews that facilities have. Just given everything we know in terms of payer coverage, sales force expansion, the general profile of the landscape. Curious if there could be a bolus of AD agitation patients. Just as a follow-up, I guess over the next, say, call it 12 months, how many prescribers do you expect may prescribe AUVELITY for both depression and for AD agitation? Thanks.

Yeah, thanks for the question, Madison. Regarding LTC bolus, I think it's difficult to predict exactly. But, you know, our team has been actively engaged with payers and LTC organizations to ensure patient access for AUVELITY. Yeah, we'll have more to share once we get into the commercial launch. In terms of MDD and ADA prescribing, I think it's important to note, I think we shared this on our call last Friday, that we'll be calling on roughly 68,000 HCPs with our extended sales team. Approximately half of those targets are considered high volume treaters of both Alzheimer's disease agitation and major depressive disorder.

I think that gives you some sense of the potential for AUVELITY being used across both indications, within a single prescriber or clinician's practice.

Understood. rep again. I don't think. Thanks.

Thank you. Next question is coming from Rudy Li from Wolfe Research. Your line is now live.

Thanks for taking my question. Just a quick follow-up to your long-term guidance of AUVELITY and AUVELITY sales. How should we think about the uptake maybe for the relatively near term, maybe in the next two, three years? Just additional color, like, on your key assumptions and what kind of give you confidence with the trajectory to AUVELITY and peak sales. Secondly, just can you talk about your OUS development plan for AUVELITY since now we already secured two indications in the U.S.? Thanks.

Yeah, thanks for the question. You know, when you think about uptake in the next two to three years, obviously, there will be a lot to learn over the next several months as we see our expanded sales force in the market for both indications. Obviously the Alzheimer's agitation indication will be new since it's a new launch. It's hard to share specifics on what we expect the uptake to be, but we have seen strong growth in new patient starts and new writer activation within MDD, which we expect to continue.

There will be another increase relative to the Alzheimer's agitation market, which shares some common targets with MDD, but there are some distinct targets that we're adding to the call plan for this year. I think we'll have more to share as we get into the Alzheimer's agitation launch. You know, the update to the peak sales estimate was guided by our internal analysis and ultimately the final label for agitation, which gives us confidence that in both indications there will be increasing frontline use of the product.

Yeah. Rudy, as it relates to OUS, our primary focus is on executing, you know, a launch in ADA and successful commercialization in the U.S. while identifying the ideal partner ex U.S. As we said in the past, our plans are to partner ex U.S. and our primary focus is to ensure that we find a partner that shares our vision for the drug in this region.

Got it. Congrats on the progress.

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, operator. Axsome today represents a singular CNS platform with our differentiated marketed products and a broad pipeline of potentially first in class and best in class treatments targeting unmet medical needs in psychiatry and neurology. We are well-positioned to deliver substantial long-term value for patients and shareholders. We look forward to providing updates on our progress throughout the balance of the year. Thank you everyone for joining us this morning. Have a great day.

Thank you. That does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.

Good morning and welcome to the Axsome Therapeutics, Inc. Fourth Quarter and Full Year 2025 Earnings Conference Call. My name is Kevin, and I will be your operator for today's call. At this time, participants are in a 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 hand the call over to Ashley Dongdress of Investor Relations. Ashley, please go ahead. Thank you.

Good morning, and thank you all for joining Axsome Therapeutics, Inc.’s fourth quarter and full year 2025 earnings conference call. With us today are Dr. Herriot Tabuteau, our Chief Executive Officer, Nick Pizzie, our Chief Financial Officer, and Ari Maizel, our Chief Commercial Officer. We will begin our call with prepared remarks. Mark Jacobson, our Chief Operating Officer, and Hunter Murdock, our General Counsel, will also be available for Q&A. Before we begin, I encourage everyone to visit the Investors section of our website to find the press release and presentation for today's call. Please note that today's discussion includes forward-looking statements regarding our financial performance, commercial strategy, and operational plans, including research, development, and activities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our SEC filings, including our quarterly and annual reports, for a description of these and other risks. You are cautioned not to rely on these forward-looking statements, which are made only as of today. The company disclaims any obligation to update such statements. And with that, I will hand it over to Herriot. Thank you, Ashley, and good morning, everyone.

2025 was a year of significant commercial, research, and development progress at Axsome. Our commercial business is strong, with Auvelity achieving sales of over $500,000,000 in its third full year of launch, Sunosi growth accelerating, and Cymbravo launching, adding a third pillar of growth. Total revenue for the fourth quarter increased 65% year over year to $196,000,000; for the full year, increased 66% to $639,000,000. Our innovative medicines continue to meaningfully improve patient outcomes. Just our current commercialized products have the potential to achieve multibillion dollars in annual peak sales. To support the continued momentum of our current products and future launches, we have built a technologically enabled scalable commercial platform. Against this backdrop, we are advancing a broad and innovative CNS pipeline, which includes five novel product candidates across nine high-impact indications. I will provide an update on our pipeline progress starting with our sNDA for Auvelity in Alzheimer's disease agitation. We recently announced the acceptance of the sNDA filing and the receipt of priority review designation with the PDUFA action date of April 30. If approved, Auvelity has the potential to address the prevalent and debilitating condition for which currently only one product is approved. As we approach the April 30 PDUFA date, launch readiness activities are underway, which Ari will discuss later in the call. We are encouraged by the level of interest within the treatment community and expect awareness to continue to build in the quarters ahead. Beyond the opportunity in Alzheimer's disease agitation, we are advancing our planned Phase III trial of AXS-05 in smoking cessation, with initiation anticipated in the second quarter. Moving to AXS-12 in narcolepsy. Following receipt of positive FDA pre-NDA meeting minutes, we have made significant progress with our NDA package, and we expect to submit that imminently. For solriamfetol, we continue to advance this differentiated molecule across multiple new indications, including ADHD, binge eating disorder, MDD with symptoms of excessive daytime sleepiness, and shift work disorder. These new indications represent significant expansion of solriamfetol's potential to help patients and create value for stakeholders. For ADHD, we recently completed a Type B meeting with the FDA, where we reached agreement on the planned Phase III studies in pediatric patients. We plan to conduct two Phase III trials in parallel, one in children and one in adolescents, and we are on track to initiate both in the first half of this year. For MDD, startup activities are underway for initiation this quarter for a Phase III trial of solriamfetol in MDD patients with symptoms of excessive daytime sleepiness. For binge eating disorder, our ENGAGE Phase III trial of solriamfetol in this indication is progressing, and we expect top-line results in the second half of this year. Finally, for solriamfetol in shift work disorder, we now anticipate top-line results in 2027, based on current enrollment trends. Turning to AXS-14. We recently initiated the FORWARD study, a Phase III double-blind, placebo-controlled, randomized withdrawal trial of AXS-14 in patients with fibromyalgia. This new study will supplement the two completed positive Phase II and Phase III trials of AXS-14 in this indication. To complement our late-stage pipeline, we recently acquired AZD7325, a novel oral GABA-A alpha-2/3 receptor positive allosteric modulator. We plan to evaluate AXS-17, the new designation for this compound, for the treatment of epilepsy based on compelling data in preclinical seizure models. Further, AXS-17 has demonstrated a favorable safety profile in over 700 patients to date. Phase II trial-enabling activities are underway, and we look forward to providing updates on this new development program in the coming months. Taken together, our growing commercial business, the potential label expansion for Auvelity, and the robust innovation across our pipeline uniquely position us to continue to deliver new treatment options for patients living with CNS disorders. With that, I'll hand the call over to Nick to review our financial results for the quarter.

Thank you, Herriot, and good morning, everyone. Our fourth quarter and full year 2025 performance reflects Axsome's growing commercial portfolio and the continued advancement of our industry-leading CNS pipeline. Together, these collective achievements firmly position us for the year ahead. As Herriot mentioned, total product revenue was $196,000,000 for the fourth quarter and $638,500,000 for the year, up 65% and 66% year over year respectively, which was driven by robust Auvelity growth, the continued solid performance of Sunosi, and initial contributions from the launch of Cymbravo. Auvelity achieved net product sales of $155,100,000 for the fourth quarter, up 68% versus the prior year. Auvelity sales surpassed the $500,000,000 mark in only its third full year from launch, totaling $507,100,000, representing a 74% year over year increase. Sunosi posted another strong quarter with net product revenue of $36,700,000, a 40% increase compared to 2024. Sunosi revenue was $124,800,000 for the full year of 2025, representing a 32% increase versus last year. Cymbravo generated $4,100,000 in net sales for the fourth quarter and $6,600,000 for the full year, following its second full quarter of launch. Together, these results underscore the continued momentum of our top-line performance and disciplined execution, which is resulting in further operating leverage in the business. Auvelity and Sunosi gross-to-net discounts in 2025 were in the high-40% range. Going forward, we expect Auvelity and Sunosi gross-to-net discounts to increase to the mid-50% range due to typical Q1 dynamics. Cymbravo gross-to-net discount for the quarter was in the high-70% range, which we anticipate will remain elevated during the launch phase. Now turning to expenses. Total cost of revenue was $12,300,000 and $47,500,000 for the fourth quarter and full year of 2025 compared to $10,500,000 and $33,300,000 for the comparable periods in 2024. Research and development expenses were $48,800,000 for the fourth quarter and $183,300,000 for the full year of 2025. That is compared to $55,000,000 and $187,100,000 for the fourth quarter and full year of 2024. The decrease in R&D spend for the year was primarily driven by the completion of clinical trials for AXS-05 and solriamfetol, which was partially offset by one-time acquisition-related costs and higher costs related to AXS-07. Selling, general, and administrative expenses were $160,300,000 for the fourth quarter and $570,600,000 for the full year of 2025. That is compared to $113,300,000 and $411,400,000 for the fourth quarter and full year of 2024. The 39% increase in SG&A spend for the year was primarily driven by commercialization activities for Auvelity, including sales force expansion and the national launch of a direct-to-consumer advertising campaign, along with the commercial launch of Cymbravo. Net loss for the fourth quarter was $28,600,000, or $0.56 per share, compared to a net loss of $74,900,000, or $1.54 per share, for 2024. The $28,600,000 net loss in the quarter includes $22,700,000 in stock-based compensation expense. Net loss for the full year of 2025 was $183,200,000, or $3.68 per share, compared to a net loss of $287,200,000, or $5.99 per share, for the full year of 2024. This year's loss of $183,200,000 includes $93,800,000 of stock-based compensation expense. Now turning to the balance sheet. We ended the year with $323,000,000 in cash and cash equivalents compared to $315,000,000 at the end of 2024. Looking ahead, we continue to believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on our current operating plan. With that, I would like to now turn the call over to Ari, who will provide a commercial update.

Thank you, Nick. Axsome delivered strong performance in Q4 and completed 2025 with momentum for Auvelity, Cymbravo, and Sunosi. Our outstanding medicines continue to meaningfully improve patient outcomes. With our planned investments for 2026 and the power of our innovative digital-centric commercialization model, we have high confidence in our ability to deliver upon the vast opportunities that remain for our growing portfolio of CNS medicines. Beginning with Auvelity, more than 225,000 prescriptions were written in the quarter, representing 42% year over year growth and 8% sequential growth. By comparison, the antidepressant market was flat over the same time period. Our sales team continues to drive uptake across prescriber segments, particularly in the primary care setting. Primary care clinicians represented approximately one-third of all Auvelity prescribers in the quarter and continue to be the fastest growing prescriber segment, further expanding the overall prescriber base alongside continued growth within psychiatry. More than 5,300 new prescribers were activated in the quarter, bringing the total number of unique prescribers to approximately 52,000 since launch. Formulary access for Auvelity also remained strong. As of January 2026, commercial coverage increased from 75% to 78%, bringing total coverage to 86% of all lives across channels, and we expect coverage to continue to expand and evolve throughout the year. Auvelity’s growth to date reflects its distinct clinical profile, fast onset of action, sustained relief from depression symptoms, and a highly favorable safety and tolerability profile, supported by execution across our innovative commercial engine, reinforcing our confidence in the significant long-term commercial opportunity for the brand. To support the growing demand in MDD, and in anticipation of the potential launch in Alzheimer's disease agitation, we recently initiated our third and largest expansion of the Auvelity sales force to approximately 600 sales representatives. We expect to complete this expansion in the second quarter and look forward to providing additional details of these plans in the months ahead. Turning now to Cymbravo, which saw acceleration in new patient trial in Q4 resulting in more than 13,000 total prescriptions and approximately 5,300 new patients started in the quarter. Our disciplined launch strategy targeting headache specialists continues to grow advocacy for Cymbravo among the highest-volume migraine prescribers in the U.S., and we are pleased with the feedback from HCPs on the positive impact Cymbravo is having on patients. The key clinical attributes leading to Cymbravo trial include the multi-mechanistic approach to migraine symptom relief targeting multiple causes of migraine, rapid onset of action, and positive impact on patient functioning within two hours. We are excited about Cymbravo's long-term potential as a preferred acute migraine treatment. We continue to make progress with Cymbravo market access and coverage, with overall payer coverage at approximately 52% at the start of the year. The proportion of covered lives in the commercial and government channels is approximately 49% and 57% respectively. In addition, Axsome successfully contracted with a third and final large commercial GPO for Cymbravo in Q4, which now enables negotiation with all major commercial payers and PBMs. We anticipate coverage for Cymbravo to expand and evolve throughout 2026. And finally, Sunosi delivered another strong quarter of performance, with more than 54,000 prescriptions representing 11% year over year and 3% sequential growth. By comparison, the wake-promoting agent market grew 2% year over year and was flat versus Q3. Nearly 500 new clinicians prescribed Sunosi in the quarter, bringing the total cumulative prescriber base to approximately 15,100 since launch. Payer coverage for Sunosi remains steady at approximately 82% of lives covered across channels. Overall, the performance of our innovative marketed products in 2025 underlines the effectiveness of our commercial strategy and execution and positions us well as we enter 2026. Auvelity, Sunosi, and Cymbravo are delivering differentiated patient outcomes in the depression, excessive daytime sleepiness, and acute migraine markets, and together represent a proliferating growth foundation for Axsome. This year, our focus remains on scaling growth across our commercial organization and expanding adoption of our important CNS medicines. I will now turn the call back to Ashley for Q&A.

Thank you, Ari. Operator, we are ready for Q&A.

Certainly. We will now be conducting a question-and-answer session. Our first question today is coming from Leonid Timashev from RBC Capital Markets. Your line is now live.

Thanks, guys. Thanks for taking my question. I wanted to ask on what the implications are for you from the new FDA publication on sort of the one-trial policy given the amount of trials that you are running. I guess I am curious whether you think that means that some of the studies in binge eating and shift work disorder could potentially be approvable on a single Phase III. And then similarly, why, given that policy, for example, you are running two studies in ADHD splitting pediatric and adolescent patients? Thanks.

Hey, Leo. This is Mark. Good morning. So, obviously, that is hot off the press, and the team is assessing it. So one thing is, as always, we always vet our clinical plans with the FDA and their vision that the programs are under. So we are going to continue to do that. And, you know, if there are changes, we will see. You mentioned shift work disorder. That is an example where we already have alignment with FDA that the existing clinical package could serve as potential support of evidence should the study that we are conducting now be positive. So, that is one example where that is the place. I will pass it to Ari for thoughts on ADHD. But our plans for ADHD reflect, you know, regional alignment that we reached with FDA. Yeah. Yeah.

Just to add to what Mark was saying. So one thing to keep in mind is, although this is a broad guidance, each clinical situation, each indication is specific and has to be looked at from that perspective. So for ADHD, it is a disorder which affects different patient populations. For example, adults with ADHD are different from children with ADHD. So as you can imagine, this is a situation whereby you would not be able to, or the FDA would not allow you to do just one study in adults, for example. We are conducting two studies in pediatric patients with ADHD because, again, there is a sub-segmentation of pediatric patients. So you have children, so those are individuals who are less than 12 years of age, and then adolescents. So typically, the FDA does require data from both subsets of patients. It is possible, for example, to study both subsets of pediatric patients in one study. We decided to split it up into two studies, which will be conducted concurrently, and that will have no impact whatsoever on our eventual filing timeline.

Thank you. Our next question today is coming from Marc Goodman from Leerink Partners. Your line is now live.

Yes. Can you talk about AXS-17, just the types of epilepsy, the development plan that you are thinking about moving into? And you had mentioned that the product has been around and has some history in patients. Just talk about what kind of data do we have? Thank you.

Thanks for the question. So the product has been studied in different indications. So one indication that has been studied in the past is generalized anxiety disorder. And all of the safety data and safety experience comes from those studies. So it is really nice that the product has been studied in a range of doses and also with chronic dosing. As it relates to the direction of going in and looking at epilepsies, this is based on a pretty broad array of preclinical studies that have been done in epilepsy models that are predictive of clinical success. And, right now, what we are doing is we are starting—we have started—the work to make sure that we are Phase II ready and also are very closely assessing all of the various different epilepsies in which the product in preclinical models has shown promise. So stay tuned, and over the balance of this year, we will provide more details on which indication—exactly which specific epilepsy—we will target first.

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

Hey, guys. Thanks for taking my question. Why don’t I just follow up on the comment about Auvelity? Payer coverage evolving over the course of the year? And one thing I just wondered about, like as you add the ADA label, sometime in April, you know, should that just mirror the MDD coverage? If not, is there a process for access build post the ADA approval? And the reason I asked, you know, I think about other CNS drugs like Caplyta, right, when they added different indications, it was a pretty seamless coverage post the label add-on event. So wondering how that looks for you guys with Auvelity and the ADA indication. Thanks.

Yeah. Thanks for the question, Jason. As you stated, in general, when you have a product that is on the market for a specific indication and you expand the indication, generally speaking, your existing coverage should apply to the new indication. I think what is unique about MDD and ADA is that MDD is largely a commercial business, whereas ADA will be more weighted to Medicare Part D. Our aspiration is to get as close as possible to 100% access for the brand, and that is something that is our aspiration. So just continuing to work with plans that do not currently cover the product and continue to work on things like removing steps in PAs where they exist today.

Thank you. Our next question today is coming from Andrew Tsai from Jefferies. Your line is now live.

Hey, good morning. Thanks for the update. And back to Alzheimer's agitation, how should we think about the initial launch cadence in the first year? Do you expect your launch to be stronger than what Rexulti saw in only Alzheimer's agitation in terms of TRx volume and sales? And then maybe as a follow-up to the gross-to-net specifically, do you think combined gross-to-net for Auvelity could trend or shake out over time? Thank you.

Thanks for the question. We do not generally forecast where we would expect ultimate uptake to land. But suffice it to say, we are actively preparing for the launch to enable commercial availability and customer engagement as soon as feasible post launch. And from our perspective, there is very limited analog in the market. Obviously, there is only one other product. So we are studying that carefully as well as the MDD launch for Auvelity to really assess where we think uptake will be on the first year. You know, once we have an approval, obviously, we will share additional details about our commercial effort. And so stay tuned for some more details later in the year.

Yeah. And hey, Andrew. Just maybe a note on the GTN. So we anticipate that 70%+ scripts for ADA will be written in the Medicare Part D channel. And as such, that channel has a more favorable GTN, specifically as there is no co-pay card utilization around that. So we would expect potential favorability from where we have been on the aggregate for Auvelity.

Thank you. Our next question today is coming from Pete Stavropoulos from Cantor Fitzgerald. Your line is now live.

Good morning, and thanks for taking my questions. For Sunosi, you had double-digit year over year growth. What were the drivers of that? Is growth more volume driven, or are you seeing benefit from improved access, persistence, or share gain? And is growth being driven more by narcolepsy or OSA? Are you seeing any differences in prescriber behavior between those two segments? Thanks.

Yes. Thanks for the question, Pete. Sunosi continues to deliver steady growth in both the OSA and narcolepsy markets. As we shared before, approximately 70% of prescriptions are EDS in OSA and 30% for EDS in narcolepsy. I think over the course of the year, we saw positive growth in new patient starts, total active writers, and total prescriptions. And part of our strategy over the past couple of years has been driving depth across existing Sunosi writers. So we are seeing growth from both ends, both OSA and narcolepsy. And really across specialty or prescriber segments, including PCPs, pulmonologists, sleep specialists, and neurologists.

Thank you. Next question is coming from Graig Suvannavejh from Wells Fargo. Your line is now live.

Hey guys, this is Craig on for Ben. I appreciate the opportunity to ask a question here. I guess, could you guys provide a little bit more color on the progress of the DTC campaign? And you mentioned that Auvelity continued to grow. However, the MDD market has been overall flat. Where is that growth coming from? Are you seeing adoption in earlier lines of care? Thank you. Bye.

Yes. Thank you for the question. Yes, as you know, we launched a national TV campaign late in the year around September–October timeframe. And we have been pleased with the impact of that campaign. It did generate inflection in new patient starts. And our analysis of the impact by media channel has enabled us to optimize our spend going into 2026. So we will have more details to share on that impact as we get through the year. In terms of where the growth is coming from, you know, we are pleased with efforts to expand use in primary care while also driving continued growth in psychiatry practices. So we are seeing really nice growth across all segments. But primary care was the fastest-growing segment in Q4 in terms of new patient starts and new writers. And so we expect that to continue to be a trend as we expand our efforts in the primary care setting.

Thank you. Next question is coming from Raghuram Selvaraju from H.C. Wainwright. Your line is now live.

Thanks so much for taking my question. I was wondering if you could comment on what you expect ultimate reimbursement market access to look like for Auvelity at steady state, particularly in the context of how Sunosi percentage covered lives is around 82%. Do you expect that to be similar for Auvelity, particularly once the product is approved both across MDD and chronic agitation? Or do you expect it to go meaningfully higher? And if so, what do you expect the ultimate optimal range to look like?

Thank you. Yes. Thanks for the question. Our goal is to try to secure access for as many patients as possible across channels. And so although we do not typically guide on what the final steady-state covered lives percentage would be, I think you have seen for the past few years that we have made steady progress in terms of increasing covered lives, and our expectation is we will continue to work to ensure access for both the MDD and ADA indication.

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

Thanks. Coming back to AXS-17, and sorry if I missed any commentary here. But can you talk about how you are thinking about it beyond epilepsy? For instance, it has been about 20 years since something has been approved for generalized anxiety disorder, and given the mechanism, it would seem that could be an interesting avenue to explore. So how are you thinking about broader development of the asset? And then secondly, just in general, are you looking at other assets to bring in to further leverage your infrastructure in both neurology and psychiatry? Thank you.

Sure. As always, with any molecule, we look very carefully at the biology. With an eye to what the possibilities are in terms of potentially affecting patients positively. So we—as you know—we in-licensed the asset. Our focus right now is with regards to epilepsies. We will obviously look at other potential indications, but we want to make sure that we stay with the initial indication. We think that there is a lot of promise there in that area based on all of the preclinical work that has been done by others and also by our team. So stay tuned, and stay tuned. And I think it is a little premature to talk about add-on indications to the primary indication.

Thank you. Our next question is coming from Ashwani Verma from UBS. Your line is now live.

Hi. Thanks for taking our question. So on the salesforce expansion, pretty big step up, twice versus the 300 reps that you had before. Yeah, just curious what went into that math and if you can talk about consensus SG&A for 2026 is only showing up 15% year over year. What would be the right range for the models? Thanks.

Yes, thanks for the question, Ash. So the salesforce expansion is designed to accelerate growth in MDD, while providing scale for a potential indication approval in Alzheimer's agitation later this year. So when you think about the expansion, the national hiring of reps throughout the country to increase reach and frequency to the highest value across specialties will enable us to capitalize on the momentum that we created in the primary care segment. And primary care is growing in importance because they are frontline treaters for both MDD and ADA. And then finally, it will allow us to engage with an expanded target universe. So a larger salesforce allows us to engage with a larger group of HCP targets when you think about the specialties that will be important for both indications. Primary care, psychiatry, neurology are really the largest specialty segments that we will be focused on.

Sure. Maybe just, Ash—maybe just a minute on OpEx and 2025 to 2026. So in 2025, in the P&L, we saw revenues growing roughly 3x faster than OpEx, so significant operating leverage in 2025. Even with this expansion, with the DTC that we have done and what we plan to do in 2026, we will continue to see that operating leverage throughout the year. Obviously, Q1, Q2, we will be building that team, as you mentioned, going from 300 to 600. But this was always factored into our cash forecast. So continue to see operating leverage into 2026.

Thank you. Our next question today is coming from Ami Fadia from Needham and Company. Your line is now live.

Hi, good morning. Thanks for taking my question. My question is on Cymbravo. With the additional third commercial payer contracted in the fourth quarter, how do you see the overall coverage evolving through the course of this year? And how should we see that impacting the gross-to-net or the rate of pull-through of prescriptions as the year progresses? Thank you.

Yes. Thank you, Ami. So as we mentioned in the call, we secured a contract with the third large GPO. And as you recall, the GPO contract is really a precursor for negotiating with payers and PBMs to secure coverage. So although it does not guarantee coverage with the payers/PBM, it does allow for active negotiation. And so our team is engaged with all the national payers and PBMs. And I think we are optimistic about the potential to increase Cymbravo coverage. That is something that we are focused on primarily for this year, and we will share some additional updates as we secure access.

Maybe just a second on GTN. GTN in the quarter for Q4 was in that upper-70% range. We would anticipate that GTN to continue to remain elevated during the launch phase. And as Ari shared, as more contracts come online, you know, we believe that the GTN will be north of where Auvelity currently is, but less than GTNs that we see in the space.

Thank you. Next question is coming from Joseph Thome, TD Cowen. Your line is now live.

Hi there. Good morning. Thank you for taking my question. Maybe just in terms of the potential Alzheimer's agitation launch, when will you be in a position to be able to launch the therapy after the April 30 date? Will it take some time before we could see kind of the full-fledged launch there? And then what sort of metrics do you anticipate providing? Should the approval come through? Would you be able to separate kind of product revenues between MDD and Alzheimer's agitation? Or how can we best monitor how that specific launch is going? Thank you.

Thanks, Joseph. Yeah. We will be ready to go within a quarter on ADA. And obviously, the team right now is preparing every aspect for launch readiness. And so we are feeling really optimistic about the potential impact, if approved. And then in terms of metrics, we expect to share approximate percentage of scripts coming from the ADA space as we learn more. As you know, the typical IQVIA data does not break out by indication. And so we have not finalized our plans, but we will certainly be able to share some details about how the launch is going.

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

Good morning, everyone, and hope everyone is well. Thanks for taking my question. On the pipeline, AXS-12, the NDA in narcolepsy, with the NDA submission plan for 12 in narcolepsy, how do you see differentiation versus existing therapies, particularly around cataplexy control and physician adoption? Thank you.

Yeah. Thanks for the question. As you know, narcolepsy is a challenging disease to treat, and patients often are on polypharmacy, trying to find the right combination of medications to support symptom relief. I think what is very clear is that not every patient responds to every mechanism in the same way, and there is a lot of trial and error. So from our perspective, AXS-12 offers a very compelling treatment option for patients, both in terms of cataplexy relief as well as safety and tolerability profile. And so we feel, you know, it is a novel mechanism relative to what is in the marketplace today. And based on the feedback we have received in market research, there is a high degree of interest in using this for narcolepsy patients.

Our next question is coming from Myles Robert Minter from William Blair. Your line is now live.

Hi, guys. Congrats on the year. Just on AXS-17, just wondering how you are thinking about the therapeutic window there in epilepsy. I know that AZD7325 should be less sedative than a benzo, but I think in the hands of AstraZeneca in their Phase II, they did show a little bit of sedation in that generalized anxiety disorder. Just wondering whether you are going to play around with dose to try and dial that out or whether the change in indication here is enough to make that an acceptable therapeutic window. Thanks, guys.

Yeah. We are—thanks for the question—we are exploring dose. And part of that exploration is a lot of PK/PD modeling. We think that, based on the preclinical data as well as the clinical data, there is a range of potential doses. And as you mentioned, depending on exactly where you fall and which therapeutic indication, you might hit certain subsets of receptors. The goal here is to make sure that we pick a dose where we have the best risk-benefit profiles. Now the drug has not been studied previously in the clinical setting in patients with epilepsy. So, there is some work there to be done and some information to be gotten from the initial trial in those patients. So stay tuned. This is what research is about, but we are very excited about the mechanism of action and the specificity of the receptor targeting.

Thank you. Our next question is coming from Matthew Baron Hershenhorn from Oppenheimer. Your line is now live.

Hey, guys. Congrats on all the progress and thanks for taking our question. So we were thinking about the safety data for Auvelity in ADA and just wondering how you see the likely label language upon the update reflecting differentiation versus Rexulti based on what we saw in the clinical trials? And how do you think about the biggest advantages for Auvelity once both treatments are available, especially considering the safety profile in elderly patients? Really appreciate it.

Hey, Matt. Good morning. Thanks for the question. The review is underway and, by the way, just a reminder, since this is a priority review, we are more than halfway through and we are just about two months out from PDUFA. So it is a little early for us to comment on potential, you know, potential label. However, what we can share is we—you know, should the product be approved—we would expect the safety profile to be described in the label in that patient population. And we would be pleased with that. And, you know, I think that is probably as much as we can say there. And could you remind me of the second part of your question, please, or maybe, Ari, you want to field that?

Yes. Just relative to the positioning, I mean, so, obviously, when you look at our clinical data—rapid onset of action, durability of response, low side effects and safety issues, not an antipsychotic option, and currently approved as a monotherapy in MDD where there is significant comorbidity with Alzheimer's agitation—so we think that there are multiple elements of the clinical profile that will really help AXS-05 sort of stand apart. And there is a lot of excitement and enthusiasm about a potential launch amongst the Alzheimer's community.

Thank you. Next question today is coming from Joon Lee, Truist Securities. Your line is now live.

Congrats on the quarter and thanks for taking the questions. This is Asim on for Joon. Just a couple from us. So are you eligible for priority review for the AXS-12 NDA submission? And I just want to make sure I understand correctly. Nick, you are saying that the gross-to-net for Auvelity should actually improve after approval given the Medicare population? Thank you.

Hey, I will take the first part of the question. Thank you for the question. Our anticipation is that AXS-12 would be a standard review. I will hand it over to Nick for the GTN.

Sure. Yeah. And correct. Based on assuming that we would see that 70%+ in the Medicare Part D channel for ADA scripts, if that is how it evolves, we would anticipate that the GTN would be more favorable. We are seeing currently in the Medicare Part D channel that it is more favorable than the commercial channel.

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

Hi, guys. Thanks for taking my questions. So maybe just on the breakdown between the community and long-term settings for ADA. Could you remind us how that breaks down and how you are planning to deploy your salesforce to address those two segments? And then if Rexulti’s coverage should be approved for the adjacent indication of AD psychosis, do you think that could become a competitor in ADA, you know, such that if patients are being treated for AD psychosis, that might also address their agitation? Thanks a lot.

Yes. Thanks for the question, David. So as a reminder, about 60% of Alzheimer's disease agitation prescriptions are in community-based settings and 40% are in long-term care facilities. So it remains to be seen how the uptake of AXS-05 will be across those settings of care, but that is sort of how the market is behaving at the moment. And then in terms of your question on Rexulti, we do view also Alzheimer's agitation and Alzheimer's psychosis as separate and distinct indications. And so we do not expect there to be much confusion in the marketplace, and agitation symptoms are the most prominent and most burdensome for patients. And so there is significant opportunity, significant unmet treatment need, and that will be our focus at launch if approved.

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

Hey, good morning. This is Eddie on for Yatin. Thanks for taking my questions. How should we think about the gross-to-net dynamics for ADA and how they are different from MDD? And then when looking at the Auvelity penetration within the PCP market segment, can you talk about how big you expect that penetration to be versus the sort of more defined neuropsych segment? Thank you.

Hey, sorry, I answered the question already a couple of times on MDD versus ADA. We would—we do—anticipate in that ADA channel to be more positive assuming that 70%+ would be in the Medicare Part D channel.

I am sorry, could you repeat the second part of your question?

Yeah. I was just wondering if you could talk about the overall penetration within the—for Auvelity—PCP segment versus the, like, more neuropsych-focused segment.

Yeah. It is a good question. Obviously, primary care is the dominant specialty in terms of overall volume. Because they tend to be the first-line treaters for MDD. That said, psychiatrists tend to have the greatest volume on a per-patient basis and see the most patients overall. So we have not specifically shared where we expect the final penetration to land in MDD. But as of today, we see about a third of our writer base is in primary care, whereas two-thirds is in psychiatry. Primary care has been growing as we have expanded our sales team and continue to penetrate the primary care segment. But where it will sort of end up at the end, it is difficult to say at the moment.

Thank you. Next question is coming from Graig C. Suvannavejh from Mizuho Securities. Your line is now live.

Hey, good morning. Thanks for taking my question. Congrats on the progress in the quarter and the year. My question is around the opportunity you see with AXS-12 for narcolepsy. I know there was a question earlier on differentiation, but maybe if you could frame the opportunity vis-à-vis potential entry of the orexin-based products. I think this has probably been asked in the past, but just wanted to see how you were thinking of the potential impact on the orexins, again fully knowing it is a polypharmacy market, but just trying to size the market opportunity here. Thanks.

Yes. As we shared before, this is a difficult-to-treat patient population. There is a lot of trial and error, and I think although there is a lot of enthusiasm for the orexin agonists, I think there is also recognition that not every patient is going to respond or necessarily get the same level of symptom relief across the spectrum of symptoms. So from our perspective, AXS-12, you know, has very strong data within cataplexy. There is daytime dosing, which is very appealing to patients, and the potential impact across functional scores as well. It is something that we hear in feedback is very promising. I think in terms of how the orexins will stack up relative to other treatments, including AXS-12, remains to be seen. But our expectation based on feedback from KOLs is that they expect polypharmacy to continue to exist significantly with the advent of a new mechanism of action in the space. Yeah. And if I may add, just as a reminder, in terms of mechanistically how these agents work, as we know, narcolepsy is a disease where we do have a loss of orexin neurons, and those directly stimulate the locus coeruleus which produces norepinephrine. So we target with AXS-12 norepinephrine. So it totally makes sense in a way both groups of products are targeting exactly the same pathway. That is one of the reasons why we are very excited about AXS-12. It makes sense mechanistically, and clinically, you know, what we have seen is not only very profound effects on cataplexy, but also positive effects on excessive daytime sleepiness and also on cognition, which we have measured pretty extensively in the program. In clinical studies that we have done, also based on the results from the long-term safety studies, these effects are consistent. The other thing that we like about AXS-12 from a mechanistic perspective is the fact that a majority of patients with narcolepsy do suffer from depression, and the mechanism of action of AXS-12 does kind of dovetail into that. So in a situation, in a clinical situation where you do have a lot of comorbidities, it is helpful to have a drug with a mechanism of action which could potentially maybe impact the other diseases which are neighbors of the primary condition. So really excited about AXS-12 and especially the fact that all these benefits are delivered with a very favorable safety and tolerability profile.

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

We thank you, everyone, for joining us on this call. Axsome is in a unique position to continue to deliver innovative medicines at the frontier of neuroscience to patients and providers. And through disciplined investment and performance across our commercial and development CNS portfolios, we expect to continue to generate significant value through the next decade and beyond, not only for patients, but for stakeholders. We look forward to keeping you all updated on these important milestones ahead.

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. Thank you for your participation today.