Thank you for joining us again this afternoon at the Citizens JMP Life Sciences Conference. Excited to be joined next by Axsome. I'm gonna turn it over to Mark Jacobson, the Chief Operating Officer, and we're also joined by CFO Nick Pizzie.
Pizzie. Yep.
Pizzie. Thank you, Nick.
Great. Yeah, thanks very much, Jason, and we, you know, thanks to the Citizens team for having us and, you know, we'll do this in two parts. Nick and I will run through a brief overview of the company, and then we'll open it up for Q&A. Thanks again for having us, and, you know, very, very quickly, of course, we've got obligatory forward-looking statements and, you know, we may be making forward-looking statements today.
Please review our filings with the Securities and Exchange Commission for a complete summary and overview of the risks and uncertainties associated with our business. You know, Axsome is a commercial and clinical stage biopharmaceutical company.
We are focused on central nervous system disorders, in particular frontiers in central nervous system disorders, and our mission is to develop and deliver transformative medicines for the hundreds of millions of people impacted by CNS conditions. 2025 highlights, Nick, you wanna cover those quickly?
Sure, yeah. 2025 was a successful year for Axsome. A couple milestones that we hit for the year from a sales perspective was Auvelity surpassed over $500 million in revenue. That was only its third year since launch. Total sales for the company were close to $640 million. Super excited. It's a nice set up for 2026 on the success that we've had in 2025. The biggest thing that we are looking forward to in 2026 is our PDUFA date for Auvelity in Alzheimer's disease agitation. That PDUFA date is on April 30, 2026, so just a couple of months away.
Currently we are in the process of expanding the team from 300 to 600, which we'll get into in a bit.
Yeah. Fundamentals just coming out of 2025, fundamentals for the business across all aspects, you know, commercial, R&D, and just the infrastructure supporting those categories of the business, it's never been better. We're very well positioned going into, as Nick mentioned, key catalysts for the organization that are potentially transformative and just continued commercial execution.
Real quick on the current state of affairs for Axsome, and we think the business is. We're in a very unique position here. We have three on-market products, which are innovative and highly differentiated, two of which we fully developed internally. That's Auvelity and SYMBRAVO.
We have five differentiated and novel product candidates, and of those, we are conducting seven late-stage clinical trials, so phase III clinical trials, that are either already underway or will be initiating shortly. That's nine of the programs that are in the portfolio, in our pipeline, have blockbuster potential, and we're focusing on 11 different conditions and those result in. You know, Nick, do you wanna cover just the potential opportunities?
Yeah. Total peak sales for the conditions that Mark spoke about is north of $16 billion, and as you can see, greater than 150 million patients that these indications affect. Importantly, though, is that we have patent protection into the 2040s.
Yeah. For all the programs. Of those 11 programs, here's the pipeline, and you know, we think about them as, you know, the overall umbrella is CNS, but we're very interested in unmet needs and in psychiatry and neurology. Here's how we break out the product candidate pipelines, and we'll review these in detail.
Yeah. Three commercial stage products in Auvelity, Sunosi, SYMBRAVO. We'll talk about peak sales shortly as it relates to them. Then multiple phase III assets that are, you know, that we're assuming positive clinical readouts, which we'll get into that as well shortly. We would expect a launch sometime in the late 20s, and then most recently AXS-17 due to the pipeline as it relates to epilepsy indication.
Here is just kind of a nice little solar system of how we think about peak sales, and as I shared earlier about the $16 billion. If you think about what we have already commercialized and continue to grow, it's in the neighborhood of $2 billion-$5 billion. That's that lower semicircle there.
Really what has gotten the most focus over the last call it several months is the AD agitation indication with the PDUFA date of April 30 that we've shared peak sales of $1.5-$3 billion for that indication alone. If you think about Auvelity, and AXS-05 is Auvelity, it'd be somewhere in the neighborhood of $2.5-$6 billion. These are peak sales that we've put out prior to launch, and we'll look to assess peak sales if and when we do receive approval.
So, recent just, you know, we touched on 2025 as a year of execution and transformation for the business. Just reviewing some of those accomplishments and recent accomplishments so far to start this year. Obviously, the launch and the approval and launch of SYMBRAVO, sNDA submission of AXS-05 for Alzheimer's disease agitation that was accepted and filed and granted priority review.
Two other items to focus on with trials. We had a number of positive trials over the past year, and then we've recently initiated the FORWARD phase III trial of AXS-14 in fibromyalgia and then the CLARITY trial, phase III trial of solriamfetol in major depressive disorder with individuals who have symptoms of excessive daytime sleepiness.
Looking ahead, we touched on obviously the sNDA PDUFA date of AXS-05 in Alzheimer's disease agitation of April 30th. We have an imminent NDA submission of AXS-12 for cataplexy and narcolepsy. We're about to push the button there. We have top-line trial readouts anticipated in the second half of this year for solriamfetol in binge eating disorder. That's the ENGAGE phase III trial, and then the SUSTAIN phase III trial of solriamfetol in shift work disorder.
We anticipate those top-line results next year, and we'll be initiating a number of trials across the product candidate pipeline in the coming months, and we'll touch on those in the coming slides. 2026, the four pillars of focus commercial performance.
Number one, continue to drive growth and, we'll cover that, but we will be investing further in all elements of the business to not only continue concurrent trajectories, but drive them further. Auvelity, prepare for launch for a potential approval if the product is approved. Advance all of the R&D programs, you know, all 11 of them, and we'll continue to do that, and we'll look towards growth there. Supporting all of that will be continued growth in the team and infrastructure that supports the business.
Again, our three main products, Auvelity, Sunosi, and SYMBRAVO. We'll dig deeper. We have slides for each one of these. Again, combined total peak sales of $5 billion across these three brands in these specific indications. Auvelity, probably the key point again is doubling the field force. We're going from 300 reps to 600 reps, and we're in the process of that recruiting. Currently, we anticipate that we'll have that completed by Q2, and ideally before the PDUFA date of April 30. Sunosi continuing to grow. We acquired that asset back in 2022, and it's been a really nice performing product for Axsome. Grew 40% year-over-year in a with a very mild to moderate level of investment into that program.
SYMBRAVO, we just launched that in June of 2025, so we're just getting off the launch pad there, and we're seeing some nice growth in scripts. Really the next key driver of growth would be to improve the payer coverage.
Auvelity, very quickly. Well, you know, oral NMDA receptor antagonist, sigma-1 agonist. It's approved for major depressive disorder in adults. Works quickly, works rapidly, sustained in a distinct tolerability profile. Very quickly, you know, Nick touched on some elements of sales to date. You know, making a very quick impact in as a treatment option for our patients in terms of in the early days, later line patients then and now about 50% of utilization, just over 50% is in first or second line or so first line or first switch. More than 50% of the scripts are coming from as monotherapy. We're seeing important growth in primary care.
Now, primary care, that makes up about a third of prescribers are primary care.
Yeah. That's really a key initiative for Axsome and for Auvelity for 2026. Part of this expansion is to drive further in the primary care market. We're currently only 0.2% of the market share in total antidepressant markets. We feel that that number can grow significantly as we get into primary care. We've been able to perform and annualize already at north of $600 million with a relatively a small field force compared to some of our peers. On average, we've had somewhere in the neighborhood of 200-250 reps during the course of this. We ended the year around 300 reps, just under 300 reps.
Being able to annualize where we are with market access that has improved, we're currently now at 86%, which we're pleased with. We're looking to further improve and evolve that, meaning to have improved formulary access. 86% total covered lives, of which 78% is in the commercial channel, 100% in the government channel, which is important as we'll talk about for ADA, Alzheimer's disease agitation, where most of the scripts will be coming in that channel. That will be one hurdle that potentially can be avoided upon the launch of ADA, where access will be available. The focus with going from 300 to 600 reps is we expect to be able to get that return on investment because we'll be able to. We have the covered lives.
We'll get in the primary care market. Also, we did a direct-to-consumer TV campaign in Q4, which we will look to continue on during 2026, but maybe at a different level than what we did in Q4.
Great. Quick snapshot of sales. Anything you wanna touch on?
Yeah, just great growth, you know, 68% in total sales, quarter-over-quarter growth, Q4 to Q4 and 74%, so surpassing $500 million in total annual sales and, you know, multiplying the 155 by four, north of $600 million annualized already, 13 quarters in. Pleased with that growth again with a relatively smaller field force team. But looking at comps 13 quarters in versus 13 quarters for other comps, we're outpacing them as well. Really pleased with the performance of Auvelity.
Yeah. That corresponds to the clinical profile. That's what we're seeing in the real world and the feedback we're getting from clinicians of how the treatment option for patients and prescribers, it's doing well. Turning to Sunosi, you know, Nick touched on this. This is a product that we acquired and we're very pleased with how it's growing for the currently approved indications. That's excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea.
Yeah, again, just continued growth. We saw 40% growth in revenue year-over-year. Demand growth has continued to grow. Thank you. Price, the price impact actually has been positive. Seeing that 40% growth and then 32% year-over-year, while we've had this asset since second quarter of 2022, I think it was launched sometime in the late around 2018, 2019, by the predecessor. Overall, again, super healthy and basically continuing to grow while we are developing it for four additional indications that are much more meaningful, even from a peak sales perspective, compared to the current indications in $300 million-$500 million right now.
We'll obviously get into those momentarily. Then just looking at Symbravo. This is our third product candidate and the second that we developed fully. This was approved about a year ago, and we launched it, as Nick mentioned, in June of last year. This is a multi-mechanistic, this is rapidly absorbed, and it's a distinct treatment approach for the acute treatment of migraine. This utilizes Axsome's MoSEIC technology, which drives absorption. You get, you know, in terms of how you reach Tmax and PK dynamics underneath, which lead to rapid pain relief, which is sustained and durable with a very nice tolerability profile.
Yeah. We're pleased with where we're at. SYMBRAVO's flying a little bit under the radar on a lot of investors' minds right now, which is fine. It's doing its thing. We've seen pockets in the country where it's really outperformed expectations and even peers at the same time at launch. We are doing it with a discrete field team. We have roughly 100 reps. Some of our peers launched with 800 reps or north of that. It's a similar playbook that we did with Auvelity out of the gate with 160 reps in a mass market. This is obviously a similar large market. As payer access comes online and as trial and adoption increases, you know, we're super excited about this asset.
I know it doesn't get a lot of play right now with Auvelity, and specifically around the ADHD indication coming about too. Looking forward to the future for SYMBRAVO.
We like the feedback we're hearing from clinicians about the product profile, and that it's aligning with the data we demonstrated for the clinical program. Real quick, we'll touch on the pipeline, and we'll just from time constraints zip through this. We touched on AXS-05 for Alzheimer's disease agitation. Reminder, it's an oral NMDA receptor antagonist, and it targets a number of pathways that are relevant in agitation. This is Alzheimer's disease agitation, which is one of the key symptoms and concerning symptoms of individuals with Alzheimer's disease. About 7 million people in the U.S. with Alzheimer's disease and north of 70% of those have symptoms of agitation. This is a critical symptom.
It often is the symptom that leads to placement in long-term care facilities. They're right now a high area of unmet need. There's only one approved product, and the majority of treatments and interventions that are used are off-label atypical antipsychotics and antidepressants. We have an sNDA, as mentioned, that's under review by the FDA right now. This is the Division of Psychiatry. The application has priority review, PDUFA date April 30th, and it's got a robust clinical program supporting that. We highlight results from the ADVANCE-1 and the ACCORD-2 trials. We have three positive trials that are part of the package, a standalone ICH safety database, and you know, we're within, you know, PDUFA is less than two months out.
You know, Nick touched on some of the pre-launch activities we are doing for a potential approval to be ready for that. We're obviously very excited about this program, both from an efficacy perspective as well as the tolerability profile that we saw in the clinical program. AXS-05 is also being developed for smoking cessation. We're about to launch a Phase III trial in this indication. We'll have more to say soon, but obviously this is a very impactful therapeutic area. You know, 34 million adults in the U.S. smoke and, as a result, you know, half of them have a disease that is related to their smoking. You know, just the healthcare impact and costs are substantial.
Stay tuned for updates here, and we'll be launching a study soon. Solriamfetol, as you know, Nick touched on for Sunosi, we have four indications that are of interest and these all tie to clinician feedback about the product profile and underlying mechanistic rationale for these areas of development, and in particular, this is dopamine and norepinephrine reuptake inhibitor. It's wake promoting, but we also see other changes that may be relevant to impulse control or inhibition and other sleep-related indications. Four phase III programs, ADHD, MDD with excessive daytime sleepiness symptoms, binge eating disorder and shift work disorder. Quick status of these studies, but we'll touch on these here individually.
Attention deficit disorder impacts, you know, a substantial number of people in the U.S., 22 million, and about 7 million are children. For our program, we have so far completed a positive Phase III trial in adults. That's the FOCUS trial, and we will be launching two trials in pediatrics, so one in children, one in adolescents, and that's coming up soon. Those are the next components of the clinical program that we plan to conduct for potential label expansion efforts. MDD with excessive daytime sleepiness symptoms, we've recently. This is a precision approach to major depressive disorder. Pardon me. Precision approach to major depressive disorder.
Approximately 50% of individuals with major depressive disorder have symptoms of excessive daytime sleepiness, and we are very interested in this for Sunosi or solriamfetol in particular, given its wake-promoting effect. This is not depression in individuals with excessive daytime sleepiness. It's the other way around. This would be for the treatment of major depressive disorder with a through a lens or component of sleep, and we do anticipate this could be a distinct indication for solriamfetol. We completed a proof of concept trial. We completed that last year and have recently launched a trial, a phase III trial here. We haven't gotten to top-line results yet, but you can expect that from us soon.
Binge eating disorder, this is in a phase III trial right now, in the ENGAGE phase III trial. This is solriamfetol, and again, there's a mechanistic rationale here that we are exploring, and we're excited about this study. We expect top-line results in the second half of this year. The final clinical program that we're running is in shift work disorder. This is obviously adjacent to the current indications, which are excessive daytime sleepiness. Here, this is another element of sleep dysregulation, and we're conducting the SUSTAIN phase III trial.
We anticipate top-line results next year and we have aligned with FDA that because this is a related condition to the currently approved programs, our expectation is if the SUSTAIN trial is positive, that's the only study we need to support potential label expansion. AXS-12, and we'll be very snappy here given we're low on time. This is our product candidate reboxetine. We have completed the clinical program. We are submitting an NDA for cataplexy in narcolepsy imminently, and we're excited about this program. It fits very nicely with the Sunosi sleep field force that we have in place now. Just very quickly on some of the clinical data and the clinical trials that support the package, the CONCERT and SYMPHONY trials, where we saw a robust impact on cataplexy.
AXS-14. This is the S enantiomer of reboxetine, so S-reboxetine. We have two completed trials, a phase II and a phase III trial, where we saw important and robust, statistically significant, highly statistically significant results in reductions in pain and an impact on fatigue. We've launched a phase III trial. This is based on feedback from the FDA that they wanted to see another fixed-dose, 12-week study with reboxetine. We launched the FORWARD trial to generate the additional data that FDA has requested of this and of us, and we'll provide guidance here for when we'd anticipate top line after we've conducted a study for some time, and we have a sense of enrollment trends. We're very excited about this program.
Here's a quick snapshot of the trial design. This is a randomized withdrawal design trial where there's a portion of open label treatment with AXS-14, and then there's a randomized discontinuation phase. Finally, we have AXS-17, which is a new program. We recently in-licensed this. This is a subtype-selective alpha-2/3 GABAA PAM, and we plan to develop this for epilepsy. 2026 is all about phase II enabling work, tech transfer, and indication selection. We'll have more to say on this program, in particular, the specific indication that we plan to launch, but we're pretty excited about this, and this rounds out the product candidate pipeline, which is very heavy in late-stage programs.
This starts to build out our early-stage pipeline. You know, all of the programs are protected by robust patent portfolios, you know, and I'll just point out that AXS-12 has Orphan Drug Designation.
Everything that Mark just talked about is fully funded. That's the great thing, we're in a fantastic financial position, $323 million on the balance sheet takes us to cash flow positivity. We've already seen quarters where we actually had cash flow positivity, specifically Q3 of 2025. Looking to further have sustained cash flow positivity and profitability shortly thereafter. Small amount of debt, around $190 million. We refinanced our loan with Hercules to Blackstone last year. Pleased with that from a cost of capital. One of the things that we've shared is that operating leverage continues in the company.
We grew revenues three times faster than OpEx in 2025, and we expect to have continued operating leverage in 2026, even with doing all these things, including the expansion that we're planning to do in the first half of this year. I think with that.
Yeah.
That concludes our presentation.
Yeah.
Great.
Yeah.
Thanks, guys. Really appreciate it. Let me throw in a couple of questions here. The field force expansion, c an you just talk to what proportion or piece of that is focused on AD agitation launch specifically versus f or example, you said growing the primary care exposure.
Yeah. Sure. We're going from 300 to 600. Those 600 reps will be doing ADA and MDD. It's gonna be depending on their call points and the way that we've recalibrated the geographies throughout the United States. The reps will have MDD call points as well as ADA call points. There's no specific, you know, reps that we focus on that. Aside from, we will have a discrete team on top of that 600 that will be calling on long-term care facilities. We currently haven't called on long-term care. Significant comorbidity with MDD, depression, and ADA in that space. That team will be focused on long-term care, but likely more in the ADA market.
There's high overlap with, especially in primary care for those who are potential prescribers for depression as well as AD agitation. Each team member within the geographies will have a mix of targets for depression, Alzheimer's disease agitation, and both.
Obviously, just a few weeks away now from the PDUFA for the agitation. I know you're not gonna say a lot here, but just FDA interactions, you know, how does e verything feel t owards the PDUFA date?
Look, for where we are today, you're correct. We just as a matter of process don't comment on, you know, real-time day-to-day updates. What we can share is, you know, Breakthrough Therapy designated prior to review, granted, and, you know, reminder, April thirtieth is the PDUFA date. We're getting very close and things are where you would expect them to be at this point in the review. You know, that comment is informed by, you know, our interactions with team, our field of vision into the Division of Psychiatry. You know, we're not aware of material changes to the team or, you know, any changes along those lines.
It's you know again things are where we'd expect them to be and we're preparing for you know potential launch if the product's approved.
Yeah. Everything's churning internally. We have actually a non-branded campaign website, ALZgoals.com, ALZgoals.com. Medical affairs team is doing its thing in preparation for the launch. Marketing, same thing, you know, doing all that prep work prior to a launch.
Great. Well, Mark, Nick, really appreciate you guys being here.
Yeah, cool.
Thank you.
Thanks for having us.
Thanks a lot, Jason. Thank you. Thanks, everybody.