NeuroPace, Inc. (NASDAQ:NPCE) Q4 2024 Earnings Call Transcript

NeuroPace, Inc. (NASDAQ:NPCE) Q4 2024 Earnings Call Transcript March 4, 2025

NeuroPace, Inc. beats earnings expectations. Reported EPS is $-0.18, expectations were $-0.25.

Operator: Greetings, and welcome to the NeuroPace Fourth Quarter 2024 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Jeremy Feffer, with LifeSci Advisors. Please go ahead.

Jeremy Feffer: Good afternoon. Thank you for joining us for NeuroPace’s fourth quarter and full year 2024 financial and operating results conference call. On today’s call, we will hear from Joel Becker, Chief Executive Officer, and Rebecca Kuhn, Chief Financial Officer. Earlier today, NeuroPace released financial results for the fourth quarter and year ended December 31, 2024. A copy of the press release is available on the company’s website at neuropace.com. Before we begin, I would like to remind you that throughout this call, we will make statements that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Any statements made during this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including those around NeuroPace’s projections, business opportunities, commercial expansion, market conditions, clinical trials, those relating to our operating trends and future financial performance, expense management, estimates of market opportunity, forecast of market and revenue growth, are based on current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements.

For more detailed descriptions of the risks and uncertainties associated with our business, please refer to the risk factors sections of our public filings with the SEC, including our recent quarterly reports on Form 10-Q, annual report on Form 10-K for the year ended December 31, 2024, to be filed with the SEC, and any other reports that we may file with the SEC in the future. This conference call contains time-sensitive information, we believe is accurate only as of this live broadcast on March 4, 2025. NeuroPace disclaims any intention or obligation, except as required by law, to update or revise any financial projections, or forward-looking statements whether because of new information, future events, or otherwise. And with that, I will now turn the call over to NeuroPace’s Chief Executive Officer, Joel Becker.

Joel?

Joel Becker: Thank you, Jeremy. And good afternoon, everyone. I will start out today’s call by reviewing our performance in the fourth quarter as well as providing additional insights around our key business priorities for 2025. Before turning the call over to our CFO, Rebecca Kuhn, to present the details of our financial performance for the quarter and year ended December 31, 2024, which will be followed by a Q&A session. Let’s get started. 2024 was a tremendous year for the NeuroPace team as we delivered on several initiatives across our business. As a result, we grew total revenue in 2024 by 22% to $79.9 million compared to $65.4 million last year with contributions from sales of the RNS system and Dixie Medical SEEG products.

The momentum in our business continued to rise steadily throughout the year and we reported record quarterly revenue in the fourth quarter. In addition, I’m very proud of our team’s ability to consistently deliver this top-line growth while also effectively managing our gross and operating margins. Our forward-looking growth plans are focused on our three-part strategy of expanding adoption and utilization within level four comprehensive epilepsy centers, expanding site of service delivery with Project CARE, and expanding the indications of use for the RNS system. This strategy is designed to drive our near and medium-term growth plans across existing and new groups of clinicians as well as patients in the large total addressable market in the US.

The first part of our strategy focused on increasing adoption and utilization of RNS systems in level four centers resulted in increasing the number of active prescribers of RNS therapy to record levels in 2024 and much of the RNS sales growth. Our core market opportunity within the level four comprehensive epilepsy centers is estimated at approximately $2 billion annually. We also made good progress throughout 2024 on expanding access to RNS therapy outside the level four CECs. We refer to this as the Project CARE program. The pilot program under this initiative was launched in early 2024. As we progressed throughout the year, we began to see an increase in the number of implants and referrals. Both the referrals and implant procedures began making a meaningful contribution to our revenue growth during the second half of 2024, a positive early trend with this program.

We’re executing these growth initiatives with financial discipline and have demonstrated gross margin improvement as well as efficient operating expense allocation, including investing in our organization, with a focus on our commercial team. The focus on these levers was demonstrated in 2024 by generating greater than 20% top-line growth while increasing operating expenses by only 7% and maintaining gross margins. However, these activities are just part of our long-range plan to drive growth. As we presented at our Investor Day in January, we are also advancing a number of key development programs across our clinical, product, and market development initiatives. With regard to clinical development, we’ve made good progress across three key programs: our post-approval study, and the Nautilus idiopathic generalized DRE and pediatric focal DRE indication expansion studies.

We recently announced positive three-year safety and effectiveness data from our ongoing five-year prospective post-approval study of the RNS system, which is the largest prospective study in neuromodulation for adults with drug-resistant focal epilepsy. This strong data showed unmatched seizure control with lasting impact. Patients experienced rapid seizure reduction, long-term relief, and 42.5% of patients in the study experienced periods of seizure freedom for six months or more. These data are a great addition to the RNS system safety and efficacy profile and we can’t wait to see the study data presented at AAN April 5th through the 9th, 2025. Moving to our ongoing Nautilus pivotal study, which I know everyone is really looking forward to seeing the top-line data in the coming months.

As the first and only pivotal clinical study to evaluate neuromodulation therapy in the idiopathic generalized epilepsy or IGE population, if successful and supports regulatory approval, it would make the RNS system the first device-based therapy with an approved indication for idiopathic generalized epilepsy. In addition, this patient segment has the potential to have more ready access to RNS in that they do not require phase two invasive monitoring and would be able to proceed to RNS system therapy faster following a non-invasive diagnostic process that could be performed both within and outside of CECs. In terms of the status of the study, we expect the primary endpoint safety and effectiveness evaluations to be performed following the completion of one-year follow-up visits later this month.

We will then plan to proceed with data readout and FDA submission in the second half of 2025. As also discussed in detail at our Investor Day, we are working on a pediatric indication for the RNS system as well with FDA and an organization called the National Evaluation System for health care technology, or NEST, an organization focused on the use of real-world data to expand indications for use, particularly to underserved populations. We believe RNS therapy for pediatric patients with drug-resistant focal epilepsy is a great candidate for this program. We are well underway on this initiative and are also working with the Pediatric Epilepsy Research Consortium or PERC on gathering an extensive set of data from a database we found with children treated with RNS therapy across 27 pediatric epilepsy centers and more than 25 peer-reviewed publications about RNS system use in pediatrics.

These data have been the topic of several meetings with FDA to discuss how we can use all of these data sources to support an expansion in our indication for use. In addition, we have the support of several advocacy groups calling for the review. We believe that we are making good progress toward the attainment of the official NEST mark of approval. If this is the result, it would mean that the FDA has agreed in principle that the data is available to develop and support a full study protocol and they will accept that as sufficient. We would then perform a data analysis along with NEST following the protocol and provide that data to FDA. We also plan to submit these data to the FDA in the second half of this year. Moving to our product development programs in our annual cadence of product releases with AI-enabled software tools, remote programming, and our next-generation platform to enable efficiency, ease of use, and increased efficacy for the platform.

As we continue to gather more and more data, we saw an exciting opportunity to use new cloud technologies to build the next-generation scalable patient data management system that will support our advancements into the future for years to come. And we plan to release our first AI-enabled software with an AI-powered seizure classifier that automatically identifies electrographic seizures. This has been designed to allow physicians an easier, more efficient path to treatment. In addition, physicians will be able to review histograms that show the progress of treatments as well as a patient’s unique circadian and multiday rhythms. These are insights designed to translate directly to patient care. These are exciting developments, which we believe will further contribute to the access to and adoption of RNS therapy.

As you can see, our team has been very busy in delivering on many fronts. And as I’ve mentioned previously, if you’ve not already had a chance, please listen to the archive of our Investor Day presentation held in January. It was a terrific event that offered some valuable insights from several KOLs and our own team members on many of the topics I discussed today. Considering the momentum in our business and exciting progress being made around each of our initiatives, we recently announced completing a public offering that we believe strengthened our balance sheet by the right amount, provided for potential increased liquidity of our stock, and allowed for organized evolution in our shareholder base. According to our recently presented long-range plan, we anticipate our cash and short-term investments will be sufficient to support our planned operations until achieving cash flow breakeven.

As a result, we have terminated our ATM offering program. As I mentioned, in addition to raising capital to support our operations, as part of our recent offering, we raised approximately $49.5 million specifically to repurchase 5,270,845 shares of the company’s common stock from KCK Limited, which was an early investor in NeuroPace. In this offering, we were able to bring in a strong new group of long-term focused investors while also providing an organized sale of all of KCK’s remaining shares. We believe that this repurchase addressed the potential overhang on our stock that selling from KCK in the open market may have had in 2024. I would like to thank KCK for their support of NeuroPace over the years. We believe that the success of this offering demonstrated a strong interest in NeuroPace among new investors and support for our long-range plans.

With that as an overview of our operational success in 2024 and goals for 2025 and beyond, let me now turn the call over to Rebecca to review our financial results for the fourth quarter of 2024 and guidance for 2025. Rebecca?

Rebecca Kuhn: Thank you, Joel. Our team has been hard at work and it is great to see these efforts reflected in our financial results in the fourth quarter as well as the building of momentum that will help drive our projected growth in the future. For the fourth quarter of 2024, NeuroPace’s revenue was $21.5 million, representing growth of 19% compared to $18 million for the fourth quarter of 2023. Revenue growth was primarily driven by increased sales of our RNS system. Excluding the contribution from Nautilus study cases in the fourth quarter of 2023, RNS sales grew by 27%. We also continued to generate meaningful revenue growth from sales of Dixie Medical products. Revenue for the full year of 2024 was $79.9 million, an increase of 22% compared to $65.4 million in 2023.

In addition, we exceeded our original revenue guidance for 2024 of $73 to $77 million. Revenue from sales of Dixie Medical products was approximately 17% of our total revenue in 2024 compared to approximately 15% in 2023. Gross margins for the fourth quarter of 2024 were 75.4% compared to 75.2% in the fourth quarter of 2023. Our gross margin increased for RNS products as our fixed manufacturing overhead costs were spread over more units, partially offset by the lower gross margin from the distribution of Dixie Medical products. R&D expense was $6.1 million in the fourth quarter of 2024, compared with $5.4 million in the same period of 2023. This increase was primarily driven by an increase in personnel and program expenses for product development, including AI-powered software and next-generation device platform projects.

SG&A expense was $13.8 million in the fourth quarter of 2024 compared with $13.2 million in the prior year period. This increase was primarily due to an increase in sales and marketing personnel-related expenses, partially offset by a decrease in general and administrative expenses. Total operating expenses were $19.8 million in the fourth quarter of 2024 compared with $18.6 million in the same period of the prior year, representing an increase of 7%. With revenue growing by 19% for the quarter, we continue to demonstrate strong operating leverage resulting from our focus on driving revenue growth while also effectively managing our operating expenses and gross margin. We plan to continue to focus on balancing these objectives. Loss from operations was $3.7 million in the fourth quarter of 2024 compared with $5.1 million in the prior year period.

We recorded $2.2 million of interest expense in the fourth quarter of 2024, compared to $2.2 million in the prior year period. Net loss was $5.3 million for the fourth quarter of 2024 compared with $6.2 million in the fourth quarter of 2023. Our cash burn in the fourth quarter of 2024 was $4.8 million. Our cash and short-term investments balance as of December 31, 2024, was $52.8 million. Subsequent to the quarter, we completed a public offering of our common stock with net proceeds of approximately $69.8 million after deducting underwriting discounts and commissions and estimated offering expenses. As Joel mentioned, we used approximately $49.5 million of the net proceeds from the offering to repurchase approximately 5.3 million shares of our common stock from KCK Limited, which ensured an orderly exit from their remaining position.

Our pro forma cash, cash equivalents, and short-term investments balance as of February 28, 2025, after completing the public offering and stock repurchase, is approximately $68.6 million. We expect our strengthened balance sheet will be sufficient to support our planned operations as represented in the long-range plan we presented at our Investor Day in January, until achieving cash flow breakeven. Our long-term borrowings totaled $59.5 million as of December 31, 2024. As a reminder, the final maturity of our debt is September 30, 2026. Regarding annual guidance for 2025, we expect our total revenue to be in a range of $92 million to $96 million, an increase of approximately 15% to 20% over 2024. This growth is expected to be mostly driven by an increase in sales of our RNS system, with growth from sales of Dixie Medical products continuing to make a meaningful contribution.

We expect our gross margin to be in a range of 73% to 75% for 2025, although we may see some small variability due to fluctuations in the proportion of Dixie Medical revenue to total revenue and other factors. We expect operating expenses for 2025 to range between $92 and $95 million, including approximately $11 million in stock-based compensation, a non-cash expense. I would now like to turn the call back over to Joel for closing remarks. Joel?

Joel Becker: Thank you, Rebecca. We’re pleased with the steady rate of revenue growth and the effective management of our margins and operating expenses, demonstrating our focus on execution of our operating priorities and financial discipline throughout 2024. The success we have had over the past year is the result of the hard work by our team. And we are focused on maintaining this momentum into 2025 and beyond. As we have mentioned previously, our goal over the course of the next three years is to have a revenue growth rate of 20% plus annually and to achieve cash flow breakeven. I look forward to updating everyone on our continued progress throughout 2025. This concludes our prepared remarks. I would now like to turn the call over to the operator, who will open the call for questions.

Q&A Session

Operator: Thank you. We’ll now be conducting a question and answer session. Thank you. Our first question is from Priya Sakhteva with UBS. Please proceed with your question.

Priya Sakhteva: Hi, guys. Thanks so much for taking the question and congrats on a solid end to the year. I guess, you could just start on the guidance for 2025. Guys could just maybe talk about some of the puts and takes to the range, you know, what gets you to the high end versus the low end, and what level of growth contribution is factored in from Project Care. And one follow-up.

Joel Becker: Thank you, Priya. Appreciate the question and we’re looking forward to 2025 and appreciate your participation here today. When we look at the guide, there are a number of things that we consider there including really execution of our three-part strategy, which is driven by acceleration of adoption and utilization within our level four centers, our building out of our Project Care growth, and our ongoing execution with regard to Dixie. As well. As we think about the things that can accelerate growth, it’s really within the level four centers, the prescriber growth as well as then expanding utilization within each of those prescribers. We talked about at the Investor Day where we were together, the opportunity to really expand Project Care and our goal being to more than double the implants and referrals from care.

And we see that as a key growth driver as well that you know, we think can really help us, have a strong 2025 and continue the momentum that we’ve got now.

Priya Sakhteva: Awesome. And then maybe just on that Project Care, that you guys called out, a strong referral base and highest number of implanters. So just to any more color on the impact from the rollout of Project Care that you could But so much.

Joel Becker: You bet. So we last quarter when we were together, we mentioned for the first time that we’ve seen meaningful impact beginning to show up in the pilot activities in Q3. We saw that continue in Q4. In fact, we saw an increase in both the referrals as well as implants in Q4 over Q3. So continued good momentum there. And a continued meaningful impact on the overall performance of the business and we’re looking forward to accelerating that and really building on it in 2025.

Operator: Our next question is from Rohan Patel with JPMorgan.

Rohan Patel: Hi. Thanks so much for taking the question, and congrats on a successful offering as well. I guess I just wanted to start with I just wanted to start with that. Obviously, there’s no shortage of opportunities here. For the business just between indication expansion and product development. So I just wanted to get a sense for how you’re prioritizing that capital over the next year or so. Where can we expect you to invest more and how are you thinking about that and the priorities into cash flow breakeven?

Joel Becker: Great question, Rohan. Thank you. As you mentioned, we do have significant opportunities for growth here in front of us. And as we’ve said previously, we’re not gonna hesitate to invest in taking advantage of those growth opportunities. And so in 2025, our focus and our investment is on accelerating the adoption and utilization within our level four centers as our foundation. That’s where the majority of our growth has been coming. And that’s where the majority of our customers and our highest concentration of patients are. And so we’ve been focused on building out incremental expansion of our commercial organization. And we’ve commented on that previously that that first group of folks is now out in the field and in under in participating in independent activities, and we are also planning further incremental expansion of the commercial organization here in 2025.

So that’s clearly an area of prioritized investment for us as well as then our direct-to-consumer efforts, we see good response. From we see elasticity in the response from our investments in direct-to-consumer awareness and education. And so those are both priorities as well as then the launch of programs, and what we’re calling Care 2.0, which are materials and other activities associated in particular with professional education around expanding both our number of targets as well as the activities around Care 1.0. So if you think about kind of impacts in 2025, those are all things that we’re investing in and focused on that can impact 2025. And then longer term, the preparing for and really scaling the organization as well as doing the work now in front of indication expansion are things that we’re investing in now and look forward to getting leverage from pending successful submittal and approvals for both the idiopathic as well as the pediatric populations.

And again, the investments we’re making now in the commercial organization and the investments we’re making now in our launch planning, we think those are all things that will put us in position to hit the ground running on those opportunities and then gain further leverage as we move through the plan.

Rohan Patel: Thanks. And then I just had a follow-up. On gross margin. You had pretty healthy expansion year over year and sequentially and think your target came about 200 basis points ahead of the street and where we were thinking. So I just wanted to get a sense for what the primary drivers were there. How do you expect that to trend into 2025? And how should we think about just gross margin generally moving forward?

Joel Becker: I’ll say a little bit, and then I’ll ask Rebecca to say a little bit too. And you’re exactly right, Rohan. We picked up, you know, 20 basis points on gross margin quarter to quarter. And 30 year on year. And so the annual gross margin performance came in at the top end of the margin guide. So revenue came in at the top end of the guide, gross margin came in at the top end of the guide, OpEx in toward the bottom end of the guide. And so I think we’re, you know, we’re walking the walk here in terms of the growth story with discipline that we talked about at the Investor Day. And really the primary contributors to gross margin for us are ongoing volume increases. The best thing we can do is continue to grow the top line in terms of those implants and sales.

And then as we’ve talked about previously as well, we do have some pricing opportunity within the RNS system and so low single-digit pricing is also something that continues to support our gross margin performance. And then good contracting discipline, being real focused on and delivering on contract discipline as well. Rebecca, what would you add there?

Rebecca Kuhn: Well, that was a pretty fulsome explanation, Joel. We do see some fluctuations quarter to quarter, and we do see a little bit of pickup in the fourth quarter. Some of that has to do with compensation costs, you know, payroll taxes being lower at the end of the year, people taking some vacations. And so it’s not surprising that we see a little pickup in the fourth quarter. But we’re comfortable with the guide we gave of 73% to 75% in 2025. We expect ongoing improvement from RNS gross margins, primarily with volume. And then, of course, that is tempered by the gross margin from a distributed product line.

Rohan Patel: Great. Thank you.

Operator: Thank you, Rohan. Next question is from Frank Takkinen with Lake Street Capital Markets.

Frank Takkinen: Great. Thanks for taking the questions, and congrats on all the progress. I was hoping you could talk a little bit more about the indication expansion as it relates to reimbursement. Is there any additional work that needs to be done in those areas as it relates to kind of generalized in pediatric?

Rebecca Kuhn: So first of all, just as a reminder, reimbursement is very well established in route in our currently indicated patient population as we move into generalized epilepsy and pediatric market. The product is the same. The coding will all be the same. Used for reimbursement. The one thing that is different is that we will need to work with payers to expand coverage criteria in their policies. Private payers have written coverage policies in place that track our FDA-approved indication really very closely. So we’ll work with them, sharing the published peer-reviewed evidence when we have that. And we’re confident that we’ll be able to get coverage policies expanded for those new indications.

Frank Takkinen: Okay. That’s helpful. And then maybe just one on the 2025 outlook. Looking back at the last few years, you haven’t really been impacted by too much seasonality. And, typically, we’ve actually seen even a step up from Q4 to Q1. Can you provide us any guidance into kind of how to think about the cadence of revenues for the year and whether or not that step up should occur again?

Joel Becker: That’s a great question, Frank. And if you look at and we talked a little bit about this last quarter, we can see a little bit of variability quarter to quarter, but if you take a look at the business kind of in six-month increments, what you see is a more smoothed out good, steady progression of growth north of 20%. We grew the business 21% in the first half of the year and 23% in the second half of the year. And so a nice acceleration of the business throughout the year. And the past couple of years, we’ve actually seen the second half of the year be a bit stronger than the first half of the year. As well. So we would expect similar kinds of trends. You know, we’re working on things that we think are gonna accelerate the growth of the business and would expect that to take place through the year and expect to see a cadence that we’d that’s similar to what we’ve seen over the past couple of years as well.

Frank Takkinen: Okay. That’s helpful. Thank you.

Joel Becker: Thank you, Frank.

Operator: Our next question is from Mike Kratky with Hi, everyone. Thanks for taking our question. And apologies for any background noise. So really encouraging to see the increase in implants and referrals from Project Care in the fourth quarter. Are you starting to see multiple implants from new accounts outside of the level four CECs and to what degree are the economics for RNS supportive outside of level four centers?

Joel Becker: Thanks for the question, Mike. It’s great to see Care continuing to pick up momentum. We do see accounts where we’ve seen multiple implants and referrals. And so that’s obviously encouraging to see folks kinda get their system down. And really start to make it a more routine part of what they do from an RNS perspective. And I’ll ask Rebecca to comment a little bit on the economics in these centers as well. But the economics are very viable. Within these centers. You know, of course, centers have different reimbursement rates and payer mix is a factor as well. But it makes sense for patients and clinicians and centers to be doing RNS implants both within the comprehensive epilepsy centers as well as within the level three and community centers too. Again, dependent to a certain degree on the variability and payer mix.

Rebecca Kuhn: Absolutely. Obviously, there are center-to-center differences, but we continue to see reimbursement rates increase looking across our broadened customer base in 2024, including the care centers. And as Joel mentioned, we think, you know, it’s very viable if you think about the cost incurred by patients that continue to have seizures, it’s really quite significant. Due to their ongoing anti-epileptic drugs and frequent emergency room visits. So it’s really an attractive value proposition to centers. And payers to for you know, to treat patients and get patient seizures under control.

Mike Kratky: Awesome. Thanks very much.

Joel Becker: Thank you, Mike.

Operator: Our next question is from Vikramjeet Chopra with Wells Fargo.

Vikramjeet Chopra: Hey, good afternoon and congrats on a finishing strong year. So one question for me. You know, Joel, you’ve talked about Project Care market expansion initiatives to more than double implants and referrals from care accounts in 2025. Can you put some more color around that or additional details and kinda we should be on the lookout for? Thanks.

Joel Becker: You bet. I think, you know, what we’re focused on is really building off of the activity from the pilot program and we’re focused on the delivery of new and different programs both educational as well as awareness for clinicians professional education programs that we do, everything from peer-to-peer as well as symposia. As well as then targeted DTC efforts where we’re able to use our digital media approaches to dial in messages to specific geographies and target those geographies. So we’re expanding all of that and watching all of that and following up with all those metrics closely. And then from an execution perspective, we’re looking at really three things. One, expanding the number of centers. So the number of care centers increasing those who are doing either referrals and or implants and were underway.

With that target group expansion now. Two, expanding the number of actual implanting centers. So you know, people who are doing everything from, you know, patient identification and diagnosis all the way through implant patient management, having fully serviced centers is another metric that we’re watching closely. And then expanding the number of programming centers as well as I’ve mentioned before a sub-segment people who are who have the patients and are happy to have them managed, but they wanna be able to refer the patient out for implant. And so the number of centers, the number of implanting centers, and then the number of programming centers are all three key metrics that we’re watching and keeping an eye on. And, again, we’ve seen good momentum with increasing referrals and implants in the second half of the year and in Q4 over Q3 and we expect that to continue.

Vikramjeet Chopra: Okay. Thanks, Joel. And just a quick follow-up. Just talk about the assumptions that get you to the top end of your revenue guidance range. Thank you.

Joel Becker: You bet. As I mentioned, the execution within the level four centers where the majority of our customers are today and expanding adoption as well as utilization within those centers is a key driver for us. As I’ve mentioned previously, we continued in 2024 to set records in terms of the number of active prescribers. So the number of clinicians that have prescribed an RNS device in the past twelve months, we continue to top those numbers and that’s a key element for us in terms of metric on adoption. So both increasing the number of prescribers and in 2024, we grew that number significantly and we grew that number significantly more and faster than we did in 2023. As well. So we’re making increasing amounts of progress even in our level four comprehensive epilepsy centers.

So then once we have people who are prescribing, building out utilization, that’s really the first plank in the strategy. The second that can really help us accelerate growth is the expansion of the care program insights. And then the third is the increased return from our expanded direct-to-consumer efforts. Those are all things that can accelerate the RNS business further. And then finally, the ongoing good work and growth that we’ve seen and are doing with Dixie as well. So those are four key leading indicators for us in terms of driving further and accelerated growth, both within as well as then to the top of the range. Next question, please.

Operator: Our next question is from Ross Osborn with Cantor Fitzgerald.

Matthew: Hi, guys. This is Matthew on for Ross today. Thanks for taking the question. I guess starting off, as you work to expand RNS system treatment to pediatrics, can you walk us through how you envision the set of service dynamics here? Would these procedures primarily be concentrated in level four epilepsy centers or do you see an opportunity for broader adoption in the community setting over time?

Joel Becker: It’s a great question. And hi, Matthew. Thanks for being on with us. So as you mentioned, we’re working hard and we feel like we’re making good progress on the towards the submission for pediatric indication. And really the way to think about the treatment for pediatric patients is much the same as you’d think about adolescent and adult patients, it’s really focused on the type of epilepsy. So for a focal patient, those patients most of the time will need phase two monitoring in that Phase II monitoring primarily takes place in comprehensive epilepsy centers. And so we would see a similar potential adoption in ImplantDynamic with pediatric patients going through the Phase II monitoring for pediatric patients that have a generalized epilepsy pending a successful trial.

In generalized epilepsy, idiopathic generalized epilepsy, those patients could also go through a similar referral and implant track as an adult patient. Where they would only need the phase one monitoring. And as a result then, those patients could be treated either in level three or outside level four centers. So really the way to think about it is not so much by age group, but by disease. And we feel like, you know, again, our site of service expansion and our indication expansion is really all under the rubric of increasing access to RNS therapy and access both in terms of the site of service as well as, you know, the label really being one that applies to all significant segments of the drug-resistant epilepsy population, PEATs being a key area of focus here for us for 2025.

Matthew: Got it. That’s helpful. And then just one more quick one for me. With an expanding market opportunity on the horizon, how are you thinking about manufacturing capacity?

Joel Becker: We’re in good shape from a capacity perspective, Matthew. We’ve got what we need. We’re ready to go.

Matthew: Got it. Good to hear. Congrats again on the quarter.

Joel Becker: Thank you.

Operator: Thank you. Our next question is from Michael Polark with Wolfe Research.

Michael Polark: Good evening. Joel, you mentioned top-line data from Nautilus potentially in the coming months. If I if you said that I missed it, have you decided on a forum or venue to show that and how and how soon. Thank you.

Joel Becker: Thanks, Mike. So, yes, so with regard to Nautilus, we expect just to reiterate, we expect a submission in the second half. We will be working to coordinate the publication and presentation of Nautilus with both the agencies and the societies, with regard to data readout on Nautilus. As we talked about during the Investor Day, our timeline of events here is that we’ll we’re working to finalize patient follow-up here in March. After we get that data, then we’ll monitor it all ensure that the data is complete then we’ll do the statistical analysis, exchange that and at which point we get alignment with the agency, we’ll have data lock and then and then be developing and then submitting to the agency and toward the tail end of that process.

From the time we have data lock and alignment with the agency to submission, then we do plan to do a data readout on the study. We’ve not identified a specific time or location associated with that, but hopefully that helps you kinda dial in the steps in the process here and just to further make the point, we do think you know, we think the Nautilus trial is, you know, it’s a first of its kind trial. And it’s a very high level of clinical evidence and study design. And we think as a result of both of those things, our a high profile publication as well as presentation, and that’s how we’re thinking about it. We plan to be submitting for both the publication presentation to significant forums so that we can really get this important information out to clinicians.

Michael Polark: Appreciate that, Joel. Thank you.

Joel Becker: Thank you, Mike.

Operator: There are no further questions at this time. I would like to hand the floor back over to Joel Becker for any closing comments.

Joel Becker: Thank you everybody for your time and your attention this afternoon. We’re really excited about the year to come and really pleased with the completion of 2024. The team is working hard to execute on the growth story, and the growth story with discipline. We’ve got a number of significant events coming up here in front of us and we look forward to keeping everybody up to date. For 2025 and at our next time to be together at the end of Q1 for our Q1 earnings call. Thanks again.

Operator: This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.