Good afternoon. Thanks for joining us again at the 25th Annual Needham Healthcare Conference. I'm Mike Matson, and I lead the MedTech and Diagnostics Equity Research team at the Needham company. I'm pleased to introduce NeuroPace. Presenting for NeuroPace today, we have CEO Joel Becker and CFO Patrick Williams.
They're going to give a presentation on NeuroPace, and then we should have time for questions at the end. If you do have any questions you'd like to ask, you can submit them electronically through the Needham conference website, or feel free to email them to me at mmatson@needhamco.com and I'll do my best to fit them in. With that, I'll turn it over to Joel and Patrick.
Thanks very much, Mike, and thanks to all for attending today. Mike, can you see and hear me okay?
Yeah.
Okay, great. Thank you. I'll get started here. I want to start with what we always start with here is the mission of what we do here at NeuroPace, and I do that because it really is what guides and catalyzes our activities and gives you a perspective as to the focus and the culture here of the business. That's really to transform the lives of patients that are suffering from debilitating seizures.
We are a company that is built of both people who are longtime NeuroPace leadership team and team members, so we have a high degree of organizational knowledge and capability as well as then, given the transformational nature of the growth that we are experiencing and the opportunities in front of us, a number of folks that have been brought in that have experiences growing and scaling businesses and expanding operations, to prepare us for everything that we've got on the way that we'll be talking about with you here today.
I'm going to start with an overview of who we are and what we look like as a company. We'll then talk a little bit about the technology itself, the RNS System.
We'll talk about recent developments around clinical data and indication expansion opportunities in particular, as well as then talk about the three key growth levers that are the core of our strategy, which is market development, clinical development, and product development. Getting started. When you think about NeuroPace, we're a business that is, in 2025, $100 million in revenue, growing at 25%. 8,000+ patients have now received the RNS System, with a growing increase in the level of penetration and patients cared for on an annual basis, as well as an increasing footprint, retesting all-time highs on a quarterly basis of both the number of accounts in which we have a presence, as well as the number of prescribers and implanters.
We've got a good growth profile that we've demonstrated here within the business in the current indications, and then a significant market opportunity in front of us.
When we think about our market, we think about it as drug-resistant epilepsy patients. If you've tried and failed more than two anti-seizure medications, you're considered to be a drug-resistant epilepsy patient. We'll talk about this a little bit more, but there are about 1.2 million drug-resistant epilepsy patients in the United States. When we think about then the number that are in Level 4 comprehensive epilepsy centers, which are the most accessible to advanced therapies for epilepsy patients, there's about 75,000 a year.
If you think about that multiplied by the ASP that we have of around $50,000 for the device, we've got a significant TAM available to us today that is then expanded with being able to move out into the community and get at the rest of that patient population, as well as expand our indications.
Associated with that, we've been demonstrating north of 20% growth here over the past two and a half- three years, and our long-range plan calls for us to continue to do that. And I think you'll see here that we're doing that on the basis of our current adult focal indication, and we have much more to come from an indication expansion perspective. And it really gives us particular confidence given the best-in-class technology that we have.
A little bit more on 2025. Attaining the $100 million revenue mark was obviously a big milestone for the company and did that with 25% growth of our RNS system really being the key to that. And, as I mentioned, increasing both an adoption as well as utilization. So we have increasing numbers of customers and then increasing utilization among those customers as well, which is hard to do.
A lot of times when you get new customers, it can take them a little longer to ramp up, and so we have a nice balance of growth throughout the business and a broadening account base to do so. That really is due to the adoption and utilization that I mentioned, as well as expansion into the broader community. We've been investing in and have made some improvements in both our commercial organization as well as our commercial leadership team that are really starting to now come to fruition as those people move through training and get out and get experience in their accounts as well as then with their new leaders. If we move from current business and current commercial execution on the left-hand side of the slide that you see here to the right-hand side of the slide, which is where are we headed?
A lot of progress in 2025 as well on our clinical programs. 1st of all, and most importantly, we submitted our PMA supplement to the FDA for indication expansion into the idiopathic generalized or IGE population. That PMA supplement went in December 15th. We have had our Q-Sub meeting as well as a series of interactive question sessions with the FDA. I'm pleased with how that's going. I feel like the conversations have been very constructive and collaborative. More work to do there yet.
If you think about 180 days tacked on to the December 15th, that puts us in a potential approval timing for mid-year of 2026, and that would open up the idiopathic generalized epilepsy population is about 20% of the entire epilepsy population, and there are no other neuromodulation devices indicated for IGE today.
In addition, we have clinical data development programs and regulatory programs for expansion into pediatrics, in particular pediatric focal patients, as well as Lennox-Gastaut patients as well. And then finally, we see the core competency that we have as the RNS system, the responsive neuromodulation system, that today as a gateway is used in epilepsy as one that can be leveraged into both paroxysmal types of central nervous system disorders, as well as more chronic biomarker disorders.
And so we have a research pipeline and are beginning to leverage insights from our RNS epilepsy work into expanded indications outside of epilepsy as well. Finally, a product development pipeline that we're very excited about.
In the Q4 of 2025, we submitted what will be the first of a series of machine learning and AI tools that leverage the data, the unique and best-in-world data set that we have for epilepsy patients and seizure monitoring to have our software and our algorithms leverage AI to make detection as well as therapy settings easier to determine and then easier to implement, improve ease of use and efficiency on the device so that clinicians can have more RNS patients in their practices and treat them better.
We also made significant development in 2025 on a number of other tools, including remote programming, which will make more and more patients available and accessible to the RNS System. That's a little bit of snapshot of 2025.
With that, I'm going to turn this part of the presentation over to Patrick F. Williams to talk to you about how we see 2026 going forward.
Thanks, Joel. At JP Morgan earlier in January, we did do a pre-announcement around that healthcare conference. Sorry about that, Mike. As normal, we did pre-announce our results, and we also gave some guidance out for 2026. There's a couple of things I did want to note. Joel went over our actuals for 2025, and you'll probably ask the question, well, you guys did $100 million in 2025. Why are you guiding to $98 million-$100 million in revenue for 2026? The answer is that what you're viewing here is what we call a discontinued operations or on a continuing operations basis.
We had a distributor business related to SEEG, and we call that our DIXI product line, and that contributed a little north of $15 million in 2025.
We have fully exited that business at the end of 2025. We'll now be reporting all of our go-forward results. We've provided a lot of reconciliations and bridging tables on our website that you can see. Our core RNS business is still growing at that 20%-22%, and that's what you're seeing here of $98 million-$100 million. You can see our non-GAAP operating expense. We also introduced an adjusted EBITDA calculation. We think it is a very good proxy for our cash generation. The adjustment in this is really stock-based compensation, and that's pretty much the largest adjustment that we're making out of our EBITDA. You can see that we have very strong gross margins.
We've talked about the fact that we've seen a very large increase in our gross margins over time.
That was another reason why we decided to exit that SEEG DIXI business. It was dragging down our gross margins quite a bit. Joel will get into this a little bit more, but the takeaway for everyone should be is that we do have a very large TAM. There's about 3.4 million people in the U.S. that are diagnosed with epilepsy. That includes both children as well as adults. The 1st course of action right now is a pharmacological one. Drugs, pills, and most people will go through that journey.
Eventually you will progress into a surgical intervention of some sort. That's what we call neuromodulation, and that's where we play in. We'll talk a little bit more about that and sort of that continuum of healthcare and that journey that the patient goes on.
As someone that's been in the med device space for a while, I will say that this healthcare journey that patients go on is a little bit more prolonged than what you may normally see. We look at that as an opportunity to try to figure out how we can shorten that through being more active and proactive with our clinical data, as well as bringing more brand awareness of our product to not only the clinical community, but also the patient community out there.
Joel hit on this a little bit, but we are the only device that what we call has a closed-loop system. The way to think about it is that we are monitoring what we call the bad actors from an electrophysiological standpoint. As those bad actors increase, we'll then stimulate.
What that does, it essentially resets, and that's what prevents a seizure. We also have the ability to record this, and so we can do things that we call remote monitoring. That allows the physician to go back, download all of the data that has been happening over the last month, let's say, and then the doctor can figure out along with the patient when a seizure did occur or if they need to adjust or tailor or customize that programming and that stimulation specifically for that patient.
This is extremely important because what we found over time, and you'll see that in the clinical data here shortly, is that we have the ability to improve results over a period of time. With that, I'll jump in what those results look like. This was actually from our original indication, which is for adult focal epilepsy.
You can see this was a largest randomized prospective trial. And you can see the results after year one all the way to year nine, and you can see that steady improvement in what we call median seizure reduction, which is one of the primary areas of focus that a doctor and the patient will look at. And then we were required, or had to do a post-approval study. And on this, you'll see the vast improvement that we've seen, 3 years of our post-improvement study. And so you can see the overlay here of a 62% in year one in median seizure reduction for F44, all the way improving by year 3 to 82% compared to the 58% in the original study.
Again, these results, we believe, are an indication of us and our clinicians being smarter out there, being able to tailor the therapy and the therapeutic specifically for that individual, and we're seeing some amazing results because of that. With that, I'm going to turn it over. Oh, 1 more, sorry. On our device versus other ones. I mentioned a couple other neuromodulation devices. Again, these are studies that we believe are more representative, ours obviously being the biggest one, an FDA study.
You can see the study group here with vagus nerve stimulation as well as deep brain stimulation. In totality, about 2x the improvement in median seizure reduction. Obviously, we're very proud of the results, but more importantly, our patients are benefiting from how great this is.
Now with that, I'll turn it over to Joel to talk about one of the new exciting areas that we're looking to expand to treat other forms of epilepsy.
Thank you, Patrick. I'll talk here a little bit about the NAUTILUS study, which is the pivotal IDE trial that is associated with our PMA supplement for expansion into the idiopathic generalized epilepsy population. Before I do get into the details on the slide here, Patrick just showed you some of the results from the post-approval study. I'm showing you here some of the results from the NAUTILUS study. I would want to emphasize that we really are the company, we're the leader, and frankly, the only company that is investing in generating results like these and clinical data like this in the drug-resistant device epilepsy population.
Stay tuned on both the NAUTILUS trial and the post-approval study. We expect here, in the relatively near term to get the publication from the post-approval study to come out.
It was originally presented in April of 2025 at the American Academy of Neurology. The American Academy of Neurology meeting takes place this coming week and weekend. We will also have a platform presentation, which is hard to get. We'll have a platform presentation at AAN with regard to the NAUTILUS results, including some of which you see here, and then some additional data around reduction in injury risk and rescue medications and some of those kinds of things as well. Looking forward to telling people more about NAUTILUS. What we've shown so far is, as Patrick was mentioning, a median reduction in seizures is one of the 1st things that people look at.
Here in this population, in particular, it's important to look at that reduction in seizures in that these patients are experiencing what are known as generalized tonic-clonic seizures, or GTCs.
If you're not quite so close to epilepsy, you can think of these as the big ones. These are the ones that you'd have probably a mental picture of what you think of someone having an epileptic seizure. They're also the ones that have the highest causality associated with both injury from seizure as well as what we call SUDEP, sudden unexpected death in epilepsy patients. What we've seen at 18 months is a 77% median reduction in GTCs, which we're really encouraged and excited about.
In addition to that median seizure reduction date, or rate rather, you can see on the right-hand side of the slide, the perception in physician-reported improvement in patients, and you can see, both over time and consistently, improvement in how these patients were doing as assessed by a Global Impression of Change.
Excited about the NAUTILUS results and currently in the process of reviewing those with the agency. When we do go in and talk with regulators, when we talk with customers, one of the things that we're focused on, and one of the things that allows us to both diversify across epilepsy indications as well as to additional disease applications outside of epilepsy, potentially, is the responsive nature of the platform allows us to truly personalize the neuromodulation.
What you see here is that really, and only in class, best-in-class ability to, again, monitor, record, and then tailor therapy and tailor both the way we place the device in terms of the specific lead placement, to be able to have that correlate with the electrophysiology of mapping the focal nature of the nidus of the seizure, and then the ability to tailor and individualize programming as well.
A flexible platform that's delivering best-in-class devices, or best-in-class outcomes through the device rather. I mentioned earlier, and I want to touch on here just briefly the power of the data that we have collected. As Patrick and I both now have mentioned, we monitor and record a patient's brain activity on an ongoing basis. We then collect all of that data back here. We have then an ability to, as you might imagine, aggregate and analyze that information. That allows us to do a couple of things.
1, it allows us to understand how do patients across types of seizures do, and it allows us then to take an individual patient and compare them to the way those types of patients do within the database and develop protocols as well as algorithms to determine what we think is going to be most effective in both detecting and treating seizures for those patients. That really has been the foundation for the foundation model work that we're doing now. Over the past couple of years,
we haven't really talked about it too much, but over the past couple of years, we've been investing in both internal organizational people, remarkable people, PhD kinds of AI people, to help build that foundation model and put us in a position to utilize this data. That's now coming into the regulatory process.
The 1st of that seizure ID, which will allow us to efficiently comb through all of the data that we get, to present to clinicians the most important parts of that data set, is currently in review and discussion with the agency. We have a number then of iterative products that will follow on from that will allow us to effectively utilize the millions, the most of anyone ever, 24 million iEEG recordings and more than 30,000 patient years to also determine what we think the potential most effective therapy settings could be.
Where we're headed with all of this is really having a device that has ongoing automaticity and adaptive capability, so that within a set of guardrails that the physician sets, the device will be monitoring, detecting, and delivering, and then updating therapy on an ongoing basis according to those algorithms that, again, the physician will always be in charge of. They'll see it all, but it allows them to be more efficient and effective in doing so. We're particularly excited not only about the data that we're generating today on clinical outcomes, but what the collection of all that data can mean for where we can head in the product pipeline. What that's allowing us to do is really build an ecosystem here of personalized therapy.
When we look across other segments in medical devices, we can see that over time, what wins is the ability to personalize therapy. Disease is complex. Individual patients are different. Their diseases have different courses, comorbidities, and temporal nature to it. This ability to adapt, record, and then tailor therapy, really puts us in a position that, as you can see from the improvement in the data over time, personalized therapy. I'm going to skip ahead here just a little bit, to get us to then talk about the individual levers that we have. I mentioned earlier, multiple growth shots on goal here, and we segment them according to market development, clinical development, and product development, and multiple initiatives under each one here that we've been working on over the past number of years that now are beginning to come to fruition.
We see as really an opportunity for us to begin to impact what we call the treatment gap. Today, there's a relatively low percentage of patients that are drug-resistant epilepsy patients that get something beyond medical management. We see with what we're able to provide in terms of best-in-class therapy effectiveness, as well as now increasing ease of use and efficiency, our focus is on really eating into that treatment gap. Additionally, we've had some regulatory success that allows us to expand beyond our original customer population, which was Level 4 comprehensive epilepsy centers, and now move out into the community as well.
While we're expanding patient footprint, we're also expanding clinician footprint. As you can see here, we've got multiple layers to the growth strategy, improved execution and adoption and utilization within our current indications, expansion of customer groups, and then expansion of indications as well.
In the end, what we see here is multiple initiatives across clinical, market, and product development that are going to put us in a position to have 2026 really be a transformational year for NeuroPace and set us up for 2026, 2027, and 2028 with multiple opportunities for us to continue to grow and diversify the business. Those were really our prepared comments for today. We'd love to take any questions and have any discussion that Mike, you or others would like to have.
Yeah. Thanks, guys. I did have 1 question that was sent to me. I'll just ask that first. The PMA supplement for generalized epilepsy, can you comment on your confidence that it's approved midyear? There's a follow-up to that.
Well, first of all, obviously, we don't know what the agency's going to do.
Okay.
What I would give you is that I feel like the discussions and the interaction have been, again, I'll repeat, I feel like they've been very constructive and collaborative. We work closely with the agency generally anyway, but the IDE here has a breakthrough device designation, which allows us to be more interactive as well. I would characterize that the interactions have been just that, interactive, constructive, collaborative. They've got their job to do and we've got our job to do, but I really like how things have been going with regard to the pre-sub discussions, the Q&A that went around that.
We put in a, what I think is a very thoughtful and thorough supplement in mid-December, and that culture has just continued post-submission as well.
The one thing I might add on that is, clearly we've talked about it now, we talked about it on our Q4 call, we talked about it at the pre-announce we did in January, that we expect a mid-year approval. I would say that the organization is driving towards a mid-year approval, and that's probably the strongest signal that we can give. I think, doing this for a little bit of time, a lot of other companies may not quite speak as we are doing. You don't know until you know for sure. We are prepping the company in order to start driving, as soon as we get that approval, and as we said, that's mid-year.
Sure. The 2nd part of the question was really around, once the approval comes, let's say it is mid-year, do you expect an acceleration in implant volumes in the H2 ? Will it be more in 2027? What have you assumed in the guidance that you've previously given around that impact?
I'll maybe start there, and then I'll ask Patrick to comment a little bit more with regard to the guide in particular, and then he also leads our reimbursement efforts as well. Obviously very quickly as you come through approvals, coverage expansion becomes important too. In the guide that we've provided so far, there is no IGE in that guide. Just for clarity, what we've guided on is our currently available adult focal business. What we're focused on then is, once we get approval, being able to target and access customers.
We know some things about this market, and the customer call point is going to be the same. The people who are putting in the device for focal implants in adults today are going to be the people who are putting in the device for IGE patients tomorrow. We know the accounts.
We've been working over the past couple of years as part of our community access and what we've called our care program, to be also expanding into the upstream referral into communities and more the general neurology as well as community-based epileptologists. We've been doing that in support of our focal business, and that's going to become even more important now when we get the IGE. We've been putting in place and have a lot of commonality with the current business as part of the indication expansion.
We're also working proactively here from a reimbursement perspective to, upon approval, we'll be in good shape with regard to the public pay patients. We have the same device and the same procedure and the same customers.
As a result, coverage is well established with private payers for adult focal, and so it'll be a matter of expanding coverage for the private pay segment, and Patrick and his team are all over that. What more would you say?
Yeah, I think, look, we haven't given out the guidance number on it, and clearly as we approach midyear, people are going to start wondering, "Well, how do I model this out?" I think people should think about this as it is the same DRG. It's the same CPT for the implanter. It's going to take some time because every single insurance company, about 50% of our coverage is through traditional private pay, so Aetna's, UnitedHealthcare, all those folks. About 30% is what we call the Advantage programs through Medicare and Medicaid, and then 20% is your traditional Medicare, Medicaid. As soon as we get FDA approval, we're off to the races on that 20%. That next 30% block, they kind of work like private pay a little bit.
Each individual state has their own Medicaid program, so we're going to have to go to them to switch out their coverage policies, and then the 50% on the end. If I think about this in sort of maybe six-month chunks, not every single provider on the insurance side is in December. Some of them are in April, some are in May. They're all over the place, right? Some of this is predicated on when we do actually get the approval. We also have to have some data in order to present in potentially some publications. I say that to say maybe that months one through six will be a little bit lighter, but then as we get in those months seven, eight, nine, 10, 11, 12, you're going to see much more of a hockey stick.
Not so much related to our opinion of adoption, but just sort of that headwind you're going to hit with them submitting for insurance and getting denied. Rest assured, we are being very proactive, offensive, the good offense and not the bad one. We're making sure that we go out there and advocate for the patients. Once you get a couple with them, it'll be a lot easier to get the next one, et cetera. I feel like we're on the right side here because, again, we have the same device with a great safety profile, great clinical efficacy.
The work of getting the payers on board. Mike, the only other thing I might add here is just that when we think about adoption dynamics with regard to the indication expansion work that we are doing, we think both IGE as well as the pediatric adolescent segments have very positive adoption dynamics here. The GTCs that these patients experience are significant in terms of the impact of their quality of life and their life as well as injury. For many of these patients, they're cognitively otherwise normal, and this is really the thing that is interrupting their lives and subjecting them to that risk. There isn't anything else approved and available.
When we think about the data that we're showing impacting the types of severe seizures that it is, and it's the only thing that's going to be available and approved, we like the adoption dynamics around the IGE population as well as then what's probably maybe even a little bit more obvious around the adoption dynamics for a pediatric and adolescent group. We see there being real opportunity here for a best-in-class technology that's already proven its safety and efficacy profile in what some might say is the toughest segment of adult focal to now be able to stand on the shoulders, all that good work, into segments that really need it, and we think can have even improved adoption dynamics.
Okay. Have you expanded your sales force or do you have plans to expand your sales force in anticipation of this? How long does it take for those sales reps to kind of ramp up productivity?
It's a great question, and knowing that all this was coming and planning this strategy and being consistent in our execution of the strategy over the past couple of years, to answer your question, it takes about a year for somebody to get trained. As you might imagine, we have relatively high expectations for these people, and so they go through classroom training, they go through in-field training, then they shadow others, and then they're really in a position to go out and represent NeuroPace. Over the past couple of years, we have been incrementally investing in that group, and it has helped continue to expand our focal business as well. We feel like we've really put in place a lot of the capacity that we think we need. Included in our plans that we've guided to for 2026 is further incremental investment throughout the year.
A lot of what we need, we have already hired and trained, and they are now available.
Yeah. Okay.
It'll be strong leverage when we get it, just because, again, it's the same call point. There'll be a little bit of marketing collateral we put together, and that's some of the reason why OpEx is a little heavier in the H of this year as we prep for that. We should get very strong translation, and that leads us to what we've talked about, which is still exiting 2027 with generating some cash. After that, we feel good about other expanded indications and other such things that will continue to drive the ability for us to have this device treat hopefully all forms of epilepsy in both adults and pedes over a period of time.
I apologize if you addressed this in the slides. I might have missed it, but I cover LivaNova, and I know they're seeing a fairly large reimbursement increase in 2026. Are you guys in the same category, or has your reimbursement improved? This is Medicare now, obviously, but has it improved as well, or were you just in a better position to begin with?
Yeah, the answer is it's a little different. The answer is same category. Our DRG is DRG 23, if you want to know the technical number. We feel good about it. There was a little bit of chatter that potentially it would get downgraded, but it did not. In fact, now we're looking to uplevel that and try to get even more reimbursement. Our inpatient is really where most of our devices are implanted and replaced.
That's a little.
Yeah, a little bit different for LivaNova. They have a very large replacement revenue stream.
Yeah.
Even their initials are sometimes done in an outpatient setting, we'll call it. Because of that, to be fair, they did get an uplevel on that outpatient, that OPPS. We did as well. We just don't do a lot of replacement right now. We'll take it, and I view this as the company will be very proactive in reimbursement and continue to see what we can do. Unlike some of the other companies in med device that have had a little bit of a hiccup on reimbursement, we don't view this as an area where we will have any sort of headwind. If anything, we see some tailwinds in the future.
Okay. All right. I think we're almost out of time, so we're going to have to wrap up there, but thanks, guys.
Appreciate it, Mike.
Thank you very much, Mike, and thanks everybody for attending today.
Thank you.