NeuroPace Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
March 4, 2025

There are 9 speakers on the call.

Operator

Greetings, and welcome to the NeuroPace Fourth Quarter twenty twenty four 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 Pfeffer with LifeSci Advisors.

Operator

Please go ahead.

Speaker 1

Good afternoon. Thank you for joining us for NeuroPace's fourth quarter and full year twenty twenty four 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 12/31/2024. A copy of the press release is available on the company's website at neuropace.com.

Speaker 1

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 and those relating to our operating trends and future financial performance, expense management, estimates of market opportunity and forecasts 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 looking statements. Accordingly, you should not place undue reliance on these statements.

Speaker 1

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 ks for the year ended 12/31/2024, 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, which we believe is accurate only as of this live broadcast on 03/04/2025. 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?

Speaker 2

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 Coon, to present the details of our financial performance for the quarter and year ended 12/31/2024, which will be followed by a Q and A session. Let's get started. 2024 was a tremendous year for the NeuroPace team as we delivered on several initiatives across our business.

Speaker 2

As a result, we grew total revenue in 2024 by 22% to $79,900,000 compared to $65,400,000 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 U.

Speaker 2

S. 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 $2,000,000,000 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.

Speaker 2

The pilot program under this initiative was launched in early twenty twenty four. 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 twenty twenty four, a positive early trend for 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.

Speaker 2

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.

Speaker 2

Patients experienced rapid seizure reduction, long term relief and forty two point five percent 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 five through the 09/2025. 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 and that they do not require Phase two invasive monitoring and would be able to proceed to RNS systems therapy faster, following a non invasive diagnostic process that could be performed both within and outside of CECs.

Speaker 2

In terms of 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 twenty twenty five. 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 Healthcare 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 PIRC 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.

Speaker 2

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 this 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.

Speaker 2

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 from an ever growing population of patients, we saw an exciting opportunity to use new cloud technologies to build the next generation scalable patient data management system

Operator

that will

Speaker 2

support our advancements into the future for years to come. And we plan to release our first AI enabled software tool later this year 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 the patient's unique circadian and multi day rhythms. These are insights designed to translate directly to patient care.

Speaker 2

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.

Speaker 2

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 $49,500,000 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 institutional 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.

Speaker 2

We 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 twenty twenty four and guidance for 2025. Rebecca?

Speaker 3

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 twenty twenty four, NeuroKases revenue was $21,500,000 representing growth of 19% compared to $18,000,000 for the fourth quarter of twenty twenty three. Revenue growth was primarily driven by increased sales of our RNS system. Excluding the contribution from Nautilus study cases in the fourth quarter of twenty twenty three, RNS sales grew by 27%.

Speaker 3

We also continued to generate meaningful revenue growth from sales of Dixie Medical products. Revenue for the full year of 2024 was $79,900,000 an increase of 22% compared to $65,400,000 in 2023. In addition, we exceeded our original revenue guidance for 2024 of $73,000,000 to $77,000,000 Revenue from sales of Dixie Medical products was approximately 17% of our total revenue in 2024 compared to approximately 15% in 2023. Gross margin for the fourth quarter of twenty twenty four was 75.4% compared to 75.2% in the fourth quarter of twenty twenty three. Our gross margin increase for R and S products as our fixed manufacturing overhead costs were spread over more units, partially offset by the lower gross margin from distribution of Dixie Medical products.

Speaker 3

R and D expense was $6,100,000 in the fourth quarter of twenty twenty four compared with $5,400,000 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 and A expense was $13,800,000 in the fourth quarter of twenty twenty four compared with $13,200,000 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 $19,800,000 in the fourth quarter of twenty twenty four compared with $18,600,000 in the same period of the prior year, representing an increase of 7%.

Speaker 3

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 $3,700,000 in the fourth quarter of twenty twenty four compared with $5,100,000 in the prior year period. We recorded $2,200,000 of interest expense in the fourth quarter of twenty twenty four compared to $2,200,000 in the prior year period. Net loss was 5,300,000 for the fourth quarter of twenty twenty four compared with $6,200,000 in the fourth quarter of twenty twenty three.

Speaker 3

Our cash burn in the fourth quarter of twenty twenty four was $4,800,000 Our cash and short term investments balance as of 12/31/2024 was $52,800,000 Subsequent to the quarter, we completed a public offering of our common stock with net proceeds of approximately $69,800,000 after deducting underwriting discounts and commissions and estimated offering expenses. As Joel mentioned, we used $49,500,000 of the net proceeds from the offering to repurchase approximately 5,300,000.0 shares of our common stock from KCK Limited, which ensured an orderly exit from their remaining position. Our pro form a cash, cash equivalents and short term investments balance as of 02/28/2025, after completing the public offering and stock repurchase is approximately $68,600,000 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 $59,500,000 as of 12/31/2024. As a reminder, the final maturity of our debt is 09/30/2026.

Speaker 3

Regarding annual guidance for 2025, we expect our total revenue to be in a range of $92,000,000 to $96,000,000 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 $92,000,000 and $95,000,000 including approximately $11,000,000 in stock based compensation, a non cash expense. I would now like to turn the call back over to Joel for closing remarks.

Speaker 3

Joel?

Speaker 2

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've mentioned previously, our goal over the course of the next three years

Speaker 4

is to

Speaker 2

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. Operator?

Operator

Thank you. We'll now be conducting a question and answer Our first question is from Priya Saksdeva with UBS. Please proceed with your question.

Speaker 5

Hi guys. Thanks so much for taking the question and congrats on a solid end to the year. I guess, if you could just start on the guidance for 2025. If you guys could just maybe talk about some of the puts and takes to the range, what gets you to the high end versus the low end? And what level of growth contribution is factored in from ProjectCare?

Speaker 5

And one follow-up.

Speaker 4

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 the execution of our three part strategy, which is driven by acceleration of adoption and utilization within our level four centers are 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 an expanding utilization within each of those prescribers.

Speaker 4

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 so we see that as a key growth driver as well that we think can really help us have a strong 25 and continue the momentum that we've got now.

Speaker 5

Awesome. And then maybe just on that project care, you guys called out a strong referral base and a highest number of implanters. So just any more color on the impact from the rollout of Project Care that you could give us? Thanks so much.

Speaker 4

You bet. So we last quarter when we were together, we mentioned for the first time that we'd 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 again 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.

Speaker 6

Hi. Thanks so much for taking the question and congrats on a successful offering as well. I guess 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. And so I just wanted to get a sense for how you're prioritizing that capital over the next year or so.

Speaker 6

Where can we expect you to invest more and just how are you thinking about that and the priorities into cash flow breakeven?

Speaker 4

Great question, Rohin. 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 going to 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.

Speaker 4

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 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.

Speaker 4

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 what we're calling CARE two point zero, which are materials programs and other activities associated in particular with professional education around expanding both our number of targets as well as the activities around Care two point zero. 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 period.

Speaker 6

Thanks. And then I just had a follow-up on gross margin. You had pretty healthy expansion year over year and sequentially and I 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 How do you expect that to trend into 2025?

Speaker 6

And how should we think about just gross margin generally moving forward?

Speaker 7

I'll say a little bit

Speaker 4

and I'll ask Rebecca to say a little bit too. And you're exactly right, Roian. We picked up 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.

Speaker 4

Gross margin came in at the top end of the guide. And OpEx came in toward the bottom end of the guide. And so I think 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.

Speaker 4

And then as we've talked about previously as well, we do have some pricing opportunity within the R and S 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 contracting discipline as well. Rebecca, what would you add there?

Speaker 3

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, 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.

Speaker 3

We expect ongoing improvement from R and S. Gross margins, primarily with volume. And then of course that is tempered by the gross margin from a distributed product line.

Speaker 6

Great. Thank you.

Speaker 4

Thank you, Rohit.

Operator

Our next question is from Frank Taconan with Lake Street Capital Markets.

Speaker 7

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 expansions 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 and pediatric?

Speaker 3

So first of all, just as a reminder, reimbursement is very well established and routine 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.

Speaker 3

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.

Speaker 7

Okay, that's helpful. And then maybe just one on 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?

Speaker 4

It's a great question, Frank. And if you look at 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 20 talk about 2024%, we grew the business 21% in the first half of the year and 23% in the second half of the year.

Speaker 4

And so a nice acceleration of the business throughout the year. And in 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. We're working on things that we think are going to accelerate the growth of the business and would expect that to take place through the year and expect to see a cadence that we that's similar to what we've seen over the past couple of years as well.

Speaker 7

Okay, that's helpful. Thank you.

Speaker 4

Thank you, Frank.

Operator

Our next question is from Mike Kratke with Leerink. Please proceed with your question.

Speaker 8

Hi, everyone. Thanks for taking our questions 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 R and S supportive outside of level four centers?

Speaker 4

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 kind of get their system down and really start to make it a more routine part of what they do from an R and S perspective. And I'll ask Rebecca to comment a little bit on the economics in these centers as well.

Speaker 4

But the economics are very viable within these centers. 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?

Speaker 3

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 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 treat patients and get patients' seizures under control.

Speaker 8

Awesome. Thanks very much.

Speaker 2

Thank you, Mike.

Operator

Our next question is from Vik Chopra with Wells Fargo.

Speaker 2

Hey, good afternoon and congrats on finishing up a strong year. So one question for me. Joel, you've talked about ProjectCare 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 kind of what we should be in the lookout for? Thanks.

Speaker 4

You bet. I think 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.

Speaker 4

One, expanding the number of centers. So the number of care centers increasing those who are doing either referrals and or implants and we're underway with that target group expansion now. Two, expanding the number of actual implanting centers. So people who are doing everything from patient identification and diagnosis all the way through implant and patient management, having fully serviced centers is another metric that we're watching closely. And then expanding the number of programming centers as well.

Speaker 4

As I've mentioned before, a sub segment is people who have the patients and are happy to have them managed, but they want to 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.

Speaker 2

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.

Speaker 4

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.

Speaker 4

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 R and S business further.

Speaker 4

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 Osborne with Cantor Fitzgerald.

Speaker 7

Hi guys. This is Matthew Park on for Ross today. Thanks for taking the question. I guess starting off as you work to expand R and S system treatment to pediatrics, can you walk us through how you envision the side of the service dynamics here? Would these procedures primarily be concentrated in level four epilepsy centers?

Speaker 7

Or do you see an opportunity for broader adoption in the community setting over time?

Speaker 4

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.

Speaker 4

It's really focused on the type of epilepsy. So for a focal patient, those patients most of the time will need Phase II monitoring and that Phase II monitoring primarily takes place in comprehensive epilepsy centers. And so we would see a similar potential adoption and implant dynamic with pediatric patients going through the Phase two 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 type.

Speaker 4

And we feel like, 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 the label really being one that applies to all significant segments of the drug resistant epilepsy population, peds being a key area of focus here for us for 2025.

Speaker 7

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 in 2026 and beyond?

Speaker 4

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

Speaker 7

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

Speaker 4

Thank you.

Speaker 3

Thank you.

Operator

Our next question is from Michael Pollard with Wolfe Research.

Speaker 4

Good evening. Joel, you mentioned top line data from Nautilus potentially in the coming months. If you said it, I missed it. Have you decided on the forum or venue to show that and how and how soon? Thank you.

Speaker 4

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, 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'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 statistical analysis with the agency, at which point we get alignment with the agency, we'll have data lock and then be developing and 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.

Speaker 4

We've not identified a specific time or location associated with that, but hopefully that helps you kind of dial in the steps in the process here. And just to further make the point, we do think we think the Nautilus trial is 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 that warrants 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. Appreciate that, Joel.

Speaker 4

Thank you. Thank you, Mike.

Operator

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

Speaker 4

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.

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Earnings Conference Call
NeuroPace Q4 2024
00:00 / 00:00