Thanks very much for joining us back at the 46th annual William Blair Growth Stock Conference. My name is Myles Minter. I'm a senior biotech analyst here at the firm. I cover Axome Therapeutics and many other neuroscience companies. Before we do get started today, I do need to point people to the room here, to important disclosures that are available on williamblair.com and also for any listeners that happen to be listening in virtually. It's my pleasure to introduce Mark Jacobson, the Chief Operating Officer at Axome Therapeutics and alongside him we've got Nick Peasey the Chief Financial Officer as well and somewhere in the audience we have Ashley Dong who heads up IR.
So with that I'll pass it over to Mark. Thanks a lot Miles. Hi everyone and thanks for being here today. We're happy to be at the William Blair Conference so thanks for having us. Real quick we'll of course start with forward-looking statements so today we may be making and board-looking statements, and we'd encourage you to review our filings with the Securities and Exchange Commission for a full description of the risks and uncertainties associated with our business. Okay, Axon Therapeutics. We are a CNS-focused biopharmaceutical company. We have a very deep pipeline. We will get into that, and we're focused on delivering highly differentiated products to patients in areas of substantial unmet need in neuroscience, psychiatry, and neurology. Okay, here's the snapshot of the company as it stands today. We have three on-market products, Avelity, Senosi, and Sembravo, across four indications, and we'll dig into these. Obviously, if you're familiar with the company, we recently announced the latest approval, that is Ovelity for agitation associated with Alzheimer's disease. We're very excited about that and we're very excited about the growth potential and investments that we'll be making in the business to drive, continue to drive performance for the on-market brands. We'll talk about that and then the pipeline we've built is a leading pipeline in CNS. So we have six product candidates, 10 indications all of high unmet need and we we think about them again through psychiatry and neurology we'll talk about those when we touch on the product candidate pipeline and we are very pleased with the the state of the business today and that outlook the we will run through shortly the investments that we'll be making in our unmarketed products, and then our plans, development plans, and milestones for the pipeline candidates.
Great, so I'll speak a little bit about the commercial products that we have, led by Avelity, then Sinossi, and then our most recent launch, Simbravo. Cumulative peak revenue guidance, we just recently gave Avelity guidance, increased that from two and a half to six billion, up to 8 billion plus for Avelity with the additional indication in ADA as well as the trajectory that we're seeing in MDD. So a total of 9.5 billion in peak sales based on only our three commercial products. So starting with Avelity, Q1 was around 150 million, 153, which was 59% year over year growth. As I mentioned, we just updated 8 billion plus. the way that we look at the peak sales is roughly a 50-50 split between ADA and MDD. We can get a little bit more into the details of how we're getting to that 8 billion in a few slides, but continued to growing the team. One of the the main drivers is we increased our field force from just under 300 reps to 630 reps, so So more than doubling the size of the team. One of the reasons why we've done that is the payer access. The product is now readily available for 86% of total lives in the United States. That's 100% in Medicare Part D, 78% in the commercial channel. So as we think about the launch for Alzheimer's disease agitation, We believe that if a doctor writes it, they will be able to actually have their patient access it because of the covered lives that I spoke to. Of those 100% covered lives in the Medicare Part D channel, 75% do not have any PA and would be either unrestricted or one-step. So again, fantastic coverage from that perspective. And then 25% of those covered lives would have potentially a PA to indication only with a step, potentially two steps. So we're continuing to work on access, but coming out of the gate with an ADA launch, we're really pleased with where we stand with access currently. One of the main drivers for our sales reps will be in primary care. Typically, we see primary care, HGPs don't necessarily like doing PAs, so having no PA necessary will really help drive those scripts. Additionally, we are going to have a team that's focused on long-term care. That's a smaller portion of that 630, but the team is well underway. We're currently being, they're currently being trained right now at our national sales meeting and looking to launch in ADA shortly. So moving on to Synose. Synose has been a great product for us. We acquired it back in 2022 and that the product continues to grow both volume as well as improving on price. So we had 34% year over year growth around 34 million in Q1 and we would expect a similar trajectory quarter by quarter for 2026 that we saw in 2025 so teams done really well we've had a small specialized team of roughly 73 reps that number has not grown investment has been relatively flat since we've launched a product and we've seen really nice year-over-year growth so really helpful from a P&L perspective super healthy business and we continue to say peak sales there of 300 to 500 million dollars multiple indications behind that which Mark will talk about shortly and then finally Simbravo. Simbravo we launched in the back half of last year growing nicely 36% sequential growth it's not necessarily a net sales story as of yet the real key to unlocking value is payer access and we did announce that we did add 17 million lives at the end of Q1 so nice win for the brand and we expect to add additional lives in the future quarter, but currently we're only around 56% total covered lives in the commercial channel. Similar story to where Avelity was. When we launched Avelity, we only had 160 reps compared to some of our peers that were north of 800. We grew Avelity as Payer Access came online. Simbravo, same story. As Payer Access continues to come online, we can further drive the business there. Peak sales of half a billion to one billion, which we feel very comfortable about.
The one thing I'd like to add is, as of this morning, we announced that all of the patent litigation pertaining to CENOZI from first-of-file generic applicants has been resolved as of this morning, and that with an entry date for those generic applicants in September 2040, so an incredibly long runway for us to continue to drive on-market performance and then also that there's a great confluence there with all the work we're doing on the development side to see if there aren't other relevant indications that could be applicable for patients. So we're really excited about that.
Maybe a minute on ovality too with the patent.
Oh sure, and with respect to ovality, that situation has already been resolved. And so the runway for Ovality is September 2038 or March 2039 with pediatric exclusivity. So also with Ovality, a very, very long time for us to get this medication to potentially appropriate patients and also further invest in potential development activities. We'll touch on some of those in a little bit.
Yeah, so next slide shows our balance sheet and financial performance. So maybe just a minute on the P&L. So our cash balance as of the end of Q1 was 305 million. We've been roughly around that 300 to 325, 330 on any given quarter. We have, our cash guidance gets us to cash flow positivity. So our current cash on hand takes us to cash flow positively and shortly thereafter profitability. So really strong balance sheet. Shares outstanding, only 51.4 million. I think that's a bit of an anomaly for biotechs from where compared to some of our other biotechs and with a market cap of 11.4 million that was dated as of the end of the quarter. And then just as you see the P&L, nice growth top line. SG&A, that number has grown a bit over the last couple quarters as we've now invested into the Avelity team. So currently Q1 we landed at 185 million. We expect that number to slightly grow. It grew from 167 to 185 from Q4 to Q1. Q1 to Q2 we would expect additional growth but not at that same dynamic from Q4 to Q1. And then essentially plateau for the rest of the year as we now have the full infrastructure for success for Avelity. and then R&D expense 53 million for Q1 that did include 10 million as it related to a BD acquisition that we did so backing that out it was really 43 million that number will likely grow slightly as the year continues as we bring in additional phase three as we start additional phase three trials but we would expect that number to be in that 50 million dollar range plus or minus five or ten percent on any given quarter so overall if you think about the broader picture, Q1 was really an investment quarter, Q2 really getting ready for that launch for ADA, and then Q3, Q4, we should really see leverage in the PNL and further quarters from there as we execute on ADA as well as the expansion around MDD.
Quickly touching on Avalide, so first and only an MDA receptor antagonist that targets, also targets Sigma-1, and that's for MDD, and as I mentioned, and now the recent approval for Alzheimer's disease agitation. We're incredibly excited about both indications and the product profile within both indications. So in major depressive disorder, rapid acting, the clinical data show separation and onset of action at one week, and continuing thereon, that's the profile we see in the real world setting as well. So very rapid onset of action, durable efficacy, with a tolerability profile that's distinct. So we do not see the same rates of AEs that are classically associated with antidepressants. These are high rates of weight gain and sexual dysfunction. There are distinct abilities distinct in terms of rates that we see there. So that also leads to what we see is good persistence and compliance in MDD. and we very much like the opportunity ahead of us to continue to drive growth in MDD alone. Nick touched on the commercial dynamics that lead to our expectations around continued growth. There's the confluence of investment in the sales team and market access, it lines up very nicely as we go broader, as we increase depth and breadth to potential prescribers. And then Alzheimer's disease agitation, very, very exciting to us in terms of the same thing, efficacy and the risk-benefit profile that we see. So we see separation starting at two weeks, STAT-SIG at week three, continuing and very, very durable. And we have, one thing I'll point out, in the label we have two different trial paradigms. You have a parallel group trial where you can observe longitudinal change. And then we have a relapse prevention trial, so a randomized withdrawal trial that shows the long-term duration of treatment. So that really speaks to the efficacy profile of the product. And then the tolerability profile is distinct in terms of rates of AEs and very, very tolerable and very few of the AEs that are often associated with pharmacotherapy in this patient populations or concerns around those. There is no box warning for this patient population. We have very low rates of AEs. The only two most common AEs that we saw, so greater than twice as much as placebo and more than 5% were dizziness and dyspepsia. So it's a very nice tolerability profile for this patient population. We're very excited about that. As Nick touched on, it's being launched this month. And so the sales team, the field force, will start to educate potential prescribers on this indication this month. We touched on growth in MDD, but just want to point out the number of targets that we've had in the prescriber base. We'll capture that here. The increased reach that we're doing by going out further into primary care. The number of patients that have tried the product to date. and what I'll just touch on briefly is early line utilization. This lines up with the state of affairs with access and Salesforce focus. So more than half of patients are first line or first switch and we really like that. That makes sense to us that the product is being used as an early line treatment for major depressive disorder.
Yeah, maybe just one note on MDD. Just from a market share perspective, we're only 22 basis points from a total TRX. So from a market share perspective, we are less than, said another way, less than a quarter of a percent of the market share for antidepressants. And that's annualizing at 600 million. Just kind of shows how massive the market is and the need for it. Granted, the majority of it is generics, but we feel that that number is going to grow. that number has grown significantly from q1 2025 to where we are as of the end of q1 2026 i think it was roughly a 50 increase slightly even more than that in market share so and that was based on the previous size field force that we have so just kind of gives you a sense of how we're thinking about roi and investing in the team to further grow the brand the other the other leading indicator is the NBRX market share, and NBRX market share is roughly 30 bps. So that is kind of will be indicative of how the TRXs will continue to grow and how our market share will look to continue to grow in market share. So kind of just summarizing a bit, we talked about the 630 reps, the reach of 68,000. Again, reinforcing the Medicare and Medicaid lives covered of 100%, super important as we think about the Alzheimer's disease agitation. One note maybe to make here is as we think about MDD, one of the areas that we have not reached out to is long-term care as it relates to the MDD indication. We have not called on long-term care. So there is a significant prevalence of depression in LTC and with the LTC team that we can now have, will be able to reach those individuals with depression as well as ADA. So 78% commercial covered lives, total that comes to 86% and as you saw on the previous slide 56%, so more than half are either unrestricted or first line, first step, excuse me.
And we've said this but it's probably not a problem to be redundant, launch is on track for this month. All right, Sanozi, so this actually was our first commercial product, and we're very pleased with the performance. We'll just touch on this quickly just for time considerations, but we're very happy with the overall state of the business, approved for excessive daytime sleepiness and narcolepsy and OSA, and solely that, that's important as we get to AXS-12, which we're also developing for narcolepsy. We'll talk about the differential there. And we touched on this, that we're investing substantially in other development programs. And the reason for that is the feedback from clinicians or observations around global improvements that patients undergo. And one item there is a few years ago, we published the SHARP study results, which showed cognitive of benefit for patients with excessive daytime sleepiness. So it's always great. Overall, as a business, we don't do segment reporting, but overall the business is incredibly healthy, which is fantastic.
Anything to touch on? No, you're good. Great.
And a couple of launch metrics and just on-market metrics 40-year-old reach and just solid, steady, persistent growth from a TRX perspective as well as improvements in market access. So we're very happy with the work that we've done, a substantial number of covered lives, but the way we've involved and improved coverage, we're very pleased with. that speaks to the financial performance that Nick touched on earlier. So Bravo, we launched that last year, and we are, Nick touched on the financial elements, but this is highly differentiated, rationally designed product to address the key need that is, despite the large number of available treatment options for patients, the key need is overwhelmingly better efficacy. And we have a product that works very, very well. We demonstrated that clinically in different patient profile types, patients that had inadequate response to prior therapy, et cetera. And we're seeing that in the feedback that we're getting from prescribers in a real-world setting. So that's great. And now we have a launch that has been designed to focus on headache centers and neurologists to drive trial. We're getting that feedback. We like what we're seeing. And now we're investing further in the brand. We touched on that, that we're expanding the sales team by 50% to drive continued growth. So we're pleased with the state of affairs for Simbravo. And here we go. Just scripts to date. and we've touched on some of these elements so we'll all move on. That's the commercial business as it stands today and we're very excited about that but when we shift to the pipeline we've built it's very, very broad, deep and now spans from early stage to numerous late stage product candidates that have at least one positive phase three trial already under its belt. So we'll review these quickly, just again for time considerations and the next milestone for each program. So AXS05, we have the two indications. We think the product is potentially relevant in a number of other neuropsychiatric indications. The first one that we've disclosed is smoking cessation. We have shared on our last call, on the Q1 earnings call, that there are other indications and areas of interest. Stay tuned. The first one that we've shared is smoking cessation, and the study startup activities are underway, so we'd expect to, in the not-too-distant future, be able to share with you when we start that study and the design of that study. So, excited about that and the opportunity there, underserved and in a very large market. So, that's AXS05. Salary Amphital, we've touched on just that that we're investing heavily in Cenozi. On the development side, there are four programs we're running. They are ADHD, binge eating disorder, MDD, but it's a precision MDD approach in patients with symptoms of excessive sleepiness, and then their shift work disorder. So ADHD, we need to study the product in both adults and pediatrics for the initial submission to FDA we have the adult study done that was a positive trial we're in the process of launching two phase three trials in children and adolescents stay tuned that'll be happening shortly the the study initiation processes and procedures are underway major depressive disorder with symptoms of excessive sleepiness we We conducted a proof of concept trial in MDD, and then we took all comers, but then we looked at also patients with symptoms of excessive sleepiness, and in fact saw a very nice signal. We're now focusing this next trial, the CLARITY phase three trial, that was initiated a few months ago in just that patient population. That's enrolling, and we'll look forward to providing updates. and then the other trial that is enrolling is the shift work the shift work disorder trial that's the sustain phase 3 trial that's chugging along so the the we've guided to top line next year you know and I did neglect to share that top line for the binge eating disorder trial is scheduled for later this year and that's on track turning to AXS 12 that is our product candidate we We touched on this already for narcolepsy, but it is for cataplexy in narcolepsy. And we have the status of that program. We've completed the clinical development program. The NDA has been submitted to FDA, and the next step there is to share FDA's acceptance decision with you all. So that is coming up, and stay tuned. We are excited about the product profile of AXS-12 in terms of, I mentioned the primary endpoints we looked at were cataplexy. We show improvements in sleep. We show improvements in cognition, differentiated product profile, daytime dosing, tolerability profile that is distinct to the molecule, say, versus what's currently available in other programs in development. And one thing that's great is if the product is eventually approved, fits incredibly well in our sleep infrastructure that's already on place with Xenozi. That's AXS-12. AXS-14, that is our program for fibromyalgia. We have two positive trials, highly statistically significant, and by way of background, so this is the esenantiomer of riboxetine, we did seek FDA's review of those two trials. One is a 12-week trial. The other is an eight-week flexible dosing design trial. This is the pain division. Their typical approach is two 12-week trials. Given how robust the results were, we did submit an application with the two studies that we have in hand. FDA did come back to us asking for their typical two 12-week trial packages. That study is underway. That's the forward phase three trial. and so you know stay tuned there we haven't guided to trial readout yet it is a randomized withdrawal design trial so we are monitoring for relapse events once we have a sense of how those are going we'll offer guidance but that is all we need that was the only item from FDA that they want to see additional from us or we're very very excited about that program and in terms of the de risking events associated with that given FDA has has you know kicked those higher, so to speak. So the need for that market is substantial, totally underserved, has been very little innovation for that indication in some time, and so we're working on that. It's a key area of focus. And then two programs that we recently acquired over the past few months, which are exciting to us because they expand the number of therapeutic areas in CNS that we're working on and their earlier stage so it's a very nice full pipeline from early stage now now to late stage so ASA 17 we're developing that for epilepsy this year it's all about phase 2 enabling work and we will then share when that's done the specific indications of interest but we're very excited about that program and then ASA 20 that's the the newest program that we acquired that is a PDE-10A inhibitor and we're starting in schizophrenia with a phase three trial planned and so the phase three trial enabling work is underway and then we're also contemplating and doing preliminary work in Tourette's syndrome so that that would follow and there are already phase two data in schizophrenia that are very, very compelling in terms of a differentiated mechanism and compelling risk-benefit profile.
Yeah, so summarizing the whole story, basically if you take a look at our commercial assets as well as our pipeline assets, we're sharing that peak sales is greater than $18 billion, of which more than half of that is already in the commercial sector. So total 18 billion in peak sales, and if you think about our P&L, we would anticipate accelerated revenue growth quarter over quarter as we launch ADA, as we continue to expand MDD. We expect operating expenses to essentially plateau, leveraging the P&L from revenues is growing at a faster pace than the OPEX, and seeing cash flow positivity and then profitability shortly thereafter.
And so we'll just leave you the framework that we approach this is to advance the frontiers of brain health for the on-market programs, which are all differentiated for areas of unmet need. And we see areas of unmet need as indications where there is nothing or say very few therapeutic pharmacotherapy options that are currently available, or areas, the AD agitation for example, or areas where there are many treatment options that are available, but the patient need is still very deep, think migraine. The year ahead, it's going to be commercial performance, and driving performance, and making investments to drive performance, so expanding avality, and then advancing the pipeline. With that, we want to thank you all for coming, and I don't know, Miles, there's probably no time for a question but five seconds pixels that's on a transcript
thanks everyone for joining us the breakout will be in Burnham a upstairs and I will ask you a question about pixels looking forward to it thank you
thank you