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NPCE earnings / call

NPCE earnings call transcript, November 12, 2026

NeuroPace Q3 2026 Earnings Call

ReplayOfficial webcast
  • Management 46%
  • Joel Becker 34%
  • Scott Schaefer 4%
  • Analysts 14%
  • Operator 2%

Management

  • Joel Becker

    Chief Executive Officer

    22 min

  • Scott Schaefer

    Vice President and Finance

    2 min

Transcribed automatically by Lician from the company's public webcast; it can contain errors and speaker names are best effort.

  1. Prepared remarks0:01
  2. Thank you for joining us, and welcome to the Neuropace Q3 2026 earnings call. After today's presentation...

  3. Operator

    ...prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. I will now hand the call over to Scott Schaefer, Vice President and Finance and Investor Relations. Scott, please go ahead.

  4. Scott SchaeferVice President and Finance

    Thank you, Operator, and welcome to Neuropace's third quarter 2026 earnings conference call. Our agenda begins with Joel Becker, Neuropace's Chief Executive Officer, who will summarize our recent performance and strategic progress, followed by a detailed financial review and outlook from Patrick Williams, our Chief Financial Officer.

  5. Following our prepared remarks, we will open the call for questions. Before we begin, I would like to remind you that certain statements made on today's call may constitute forward-looking statements within the meaning of federal securities laws. These statements... ...include, among others, comments regarding our financial outlook for 2026 and preliminary expectations for 2027, our commercial strategy, our analyses of our third quarter commercial performance, and our projections toward effectiveness... ...of future commercial execution, clinical and product development initiatives, regulatory matters, including potential indication expansion into idiopathic generalized epilepsy, or IgE, and pediatric ages 12 to 70... ...17 years of age focal epilepsy, and our expectations regarding operating performance and profitability. Forward-looking statements are based on management's current expectations and assumptions, and are subject... ...to risks and uncertainties that could cause actual results to differ materially. A discussion of these risks and uncertainties can be found in today's press release and in our filings with the Securities and Exchange Commission, including our most recent Form 10-K and Form 10... We undertake no obligation to update or revise any forward-looking statements except as required by law. Unless otherwise noted, the financial results today reflect continuing operations and...

  6. and exclude our former SEEG distribution business or Dixie Medical in both the current and comparable prior periods. We will also discuss certain non-GAAP financial measures, including adjusted EBITDA. Reconciliations to the most directly... comparable GAAP measures are included in today's earnings release, which is available on the Investor Relations section of our website. With that, I will now turn the call over to Neuropace's Chief Executive Officer, Joel Becker. Joel?

  7. Joel BeckerChief Executive Officer

    Thanks, Scott, and good afternoon, everyone. Our third quarter results fell short of our expectations, and I want to be direct about why and also what we're doing about it. I will begin with our results in the factors that affected performance, then provide updates on our IGE regulatory process, our pediatric focal epilepsy program intended for adolescents 12 to 17 years of age, and our product development initiatives. After that, Patrick will review our financial results in revised outlook. Total revenue in the third quarter was $23.1 million, including RNS system revenue of $22.9 million. Representing RNS growth of approximately 1% year-over-year. This result fell well short of our expectations and does not reflect the growth the business has, and we believe we can. Delivered. I am, and we are as a team, accountable for that execution, and we have learned a considerable amount about the specifics of reducing the friction of moving patients through the pipeline to implant. We have consistently communicated our conviction in the growth potential of RNS, and that remains our view. We have made meaningful progress in translating the significant clinical need for RNS therapy into a durable, high-growth business. As the report did not match our historical trajectory, the underlying patient need and market opportunity remains and is substantial. We are addressing the factors that affected performance while advancing several important near-term catalysts that can expand.

  8. Expand adoption and support sustained growth. Additionally, I remain very excited about the progress we are and have been making in developing the market, the R&S technology platform, and our clinical data and indication expansion efforts. Let me walk through some of the specific factors that impacted our third quarter results. During and following the quarter, we conducted a detailed review of performance across the market, individual sales territories, and accounts. That review I did cite several factors that contributed to the shortfall, many of which we believe are transient. We have already taken action to address a number of these issues and remain focused on improving execution. First, a meaningful portion of the shortfall was concentrated in several of our largest accounts. At a number of these centers, local operational issues affected patient evaluation and procedural scheduling. These included changes in staffing, physician availability, and diagnosis. Procedure capacity. We view these as account specific issues rather than evidence of a broader national slowdown in interest in RNS. These prescribers continue to be enthusiastic supporters. of our RNS therapy and we have begun to see recovery at a number of these accounts in the fourth quarter. At the same time, the breadth of our business continues to expand. A larger portion of our volume now comes from a broader group.

  9. We see this as a positive development because it broadens access and creates additional opportunities for growth. Our focus is on helping these physicians and centers move from good to great users of R&S through clinical education. Technology support and stronger referral pathway development. Growing utilization across this broader account base complements our efforts to restore implant cadence at our highest volume centers. Second, at midyear, we made a meaningful number of changes. To sales leadership and local field roles, specifically parts of our field clinical engineer team. These changes were necessary to both strengthen and position ourselves to scale the field organization for the opportunities ahead. However, we believe these changes and transitions created disruption in some territories in the immediate term and that affected our results in certain accounts during the quarter. These field structural changes are now complete, but it will take some time for them to reach their full benefit. Third, we are addressing the commercial impact of our exit from the SEEG distribution business. The operational transition away from this business in late 2025 and early 2026 went as planned. However, the business had provided our field team with more regular access to the operating room and opportunities with neurosurgeons earlier in the patient journey. Particularly during phase two diagnostic evaluations. Many of those relationships were at our largest RNS accounts. Given the six to nine month patient pathway from identification to implant, the impact of reduced routine in

  10. engagement became more apparent in our third quarter results. We have since addressed these dynamics at these accounts and are seeing improved performance in our former SEG accounts when compared to the rest of our account base. The quarter also highlighted additional opportunities to strengthen how we operate and scale the company. We are acting on those lessons through expanded commercial coverage, enhanced patient pipeline tools and information. and more consistent planning and execution. We are building these capabilities now to improve performance within adult focal and prepare for potential expansion into IGE and pediatric adolescent focal epilepsy. Alongside our continued investment in clinical development and product innovation, we are accelerating investment in our sales organization, expanding account coverage, and strengthening referral development and patient pipeline. These actions are intended to improve execution today and prepare us for potential expansion into IGE and adolescent focal epilepsy. Together with our product pipeline, we believe these opportunities position NeuroPace for sustained growth. We are focused on building the capabilities needed to deliver it. Patient need and underlying clinician interest in and demand for RNS therapy remains strong. We again reached a new high in active prescribers during the which reinforces our confidence in the continued expansion of physician adoption. However, we also recognize that broader interest needs to translate into completed procedures and revenue.

  11. That is where our commercial efforts are concentrated. It is worth noting, looking forward, that the adult focal patient pathway involves lengthy diagnostic evaluations and multiple steps between referral and implant. As a result, improvements in account management and commercial execution can take time to translate into procedural volume. And we expect the recovery to develop over the next several quarters. Our near and medium term growth expectations reflect that timing. Fourth quarter procedure volumes have shown signs of recovery. However, we are taking a prudent approach to our expectations for the remainder of the year. Accordingly, we are revising total revenue guidance to a range of $91 million to $92 million, including R&S revenue of $90 million to $91 million. Looking ahead, 2027 is shaping up to be another important year for Neuropace, with multiple near-term potential catalysts across our clinical and product development programs, including remote care and IT. We will provide more detail on our outlook as we close out the year, but our current expectation is for our core R&S full-year revenue growth to be approximately 15%, with an acceleration toward 20% as we exit. 2027. Consistent with our approach to initial 2026 guidance, this outlook excludes any contribution from IGE indication expansion. We will assess that opportunity. Following potential FDA approval, Patrick will walk through our revised 2026 financial guidance and initial 2027 guidance in more detail later in the call. Turning briefly to reimbursement.

  12. CMS recently released its final 2027 OPPS rule which increases the hospital outpatient payment rate for the APC covering RNS replacement procedures by approximately 11%. Replacements remain a small but growing portion of our procedure mix and we expect this reimbursement improvement to continue to provide an ongoing tailwind as replacement volumes increase. We will continue to advocate for appropriate reimbursement across both inpatient and outpatient settings to expand patient access to RNS therapy. Let me now turn to clinical development beginning with our Nautilus program and the IGE PMA supplement. We completed our submission issue request or SIR meeting with the FDA earlier in the fourth quarter. We are incorporating the agency's feedback and expect to submit our amendment around year end. The discussion was consistent. With our expectations and reflected the interactive and collaborative dialogue we have experienced with the agency throughout this process. We believe we made meaningful progress in clarifying the clinical evidence and aligning on the specific analysis. The FDA would like to see in the amendment. We remain confident in the totality of the Nautilus clinical evidence and in the potential benefit of RNS therapy for patients with drug resistant IgE. In our discussion with the FDA, we again highlighted the 24 month results showing a 100% median reduction in generalized tonic-clonic seizures, which we believe demonstrate a meaningful clinical benefit for this underserved population.

  13. Our focus remains on presenting the evidence clearly and comprehensively and responding promptly to the agency's questions as the review progresses. On timing, as previously, discussed, our planning continues to allow for a full 180-day FDA review of the amendment. On that basis, the timeline would result in a potential approval by mid-year 2027. As we continue to believe an earlier outcome is possible, the middle of 2027 is a reasonable planning assumption. As always, the timing and outcome will ultimately depend on the agency's review. I'm looking forward to continuing this dialogue and working toward bringing RNS to patients with drug-resistant IgE. RNS would be the first FDA-approved device therapy for this population, providing an important new option for patients with the most severe... ...type of seizure that remains uncontrolled despite medication. We also believe IgE offers particularly favorable adoption dynamics for both physicians and patients, including a more streamlined evaluation pathway than an adult focal... ...of epilepsy, given that it does not require a Phase II SEEG diagnostic procedure. Together, these factors could support faster adoption and make IgE a significant growth catalyst beyond our current indication. Moving... ...to adolescent focal epilepsy, we remain committed to a real-world evidence approach to support a potential indication expansion. Our work has focused on bringing together existing clinical data in a standardized way to...

  14. ...to evaluate safety and effectiveness in this patient population. To further supplement that effort, we initiated enrollment in Aurora, a retrospective observational study of patients who were between the ages of 12 to 17 years old... ...when they received the RNS system for drug-resistant focal epilepsy in routine clinical practice. The study is designed to include up to 100 evaluable patients and uses patient-authorized electronic health records. ...supplemented by physician and patient-reported outcomes collected through a centralized study site. The purpose is to evaluate safety and seizure outcomes using the experience of patients who have already been implanted and... ...support an FDA submission for focal adolescent indication expansion. We estimate the number of adolescent focal patients in this 12 to 17 year age group represents roughly 70,000 patients or... over 3.5 billion dollars in opportunity post-approval. Because Aurora collects data from patients already treated in clinical practice, enrollment refers to obtaining consent and authorization to collect their... records and outcomes. It does not require enrolling patients for new implants and then waiting for a prospective follow-up period. We expect enrollment to be completed in early 2027, followed by... completion of data collection, analysis, and preparation of our submission. We are evaluating multiple pathways for bringing the available evidence together, and we believe there is a path to submission in 2027 and potential approval by...

  15. the end of 2027 or early 2028, subject to the data and FDA review. As with IGE, we also believe adolescent focal epilepsy offers favorable adoption dynamics, with parents and caregivers playing... an active role in pursuing additional treatment options for children whose seizures remain uncontrolled. Combined with physician interest in RNS and its ability to provide ongoing brain activity data to guide personalized therapy, we believe this... family engagement can support increased adoption following approval. Alongside IGE, adolescent focal represents a meaningful opportunity to reach more patients and accelerate growth. We will continue leading the field. Building clinical evidence generation with the goal of establishing RNS as a standard of care across an increasingly broad set of approved epilepsy indications. Turning to product development. Remains robust and continues to progress. During the third quarter, we submitted remote care to the FDA ahead of our previously communicated year end timeline. Remote care is designed to allow physicians to program the RNS system through telehealth. Reducing the need for certain in-person visits and has the potential to expand the number of patients who are considered to be good candidates for RNS therapy. For patients who do not live close to an epilepsy center, the travel and logistical demands of ongoing care can be a meaningful barrier to choosing and maintaining treatment. We believe remote care can help address that barrier while giving physicians greater flexibility in managing their

  16. patients. This capability is particularly important as we broaden access to RNS and work toward potential indication expansion. Our goal is to make the therapy easier for physicians to deliver and easier for patients and families. to access without requiring each programming visit to take place at a comprehensive epilepsy center. Remote care was submitted as a PMA supplement based on an anticipated 180 day review framework. We believe approval is possible. in the second quarter of 2027, subject to the FDA's review and any additional information requests. Remote care is one part of a broader product strategy that includes ECOG assistant, additional AI-enabled tools, and our next-generation platform. We believe the combination of indication expansion and continued product innovation represents substantial long-term growth drivers for NeuroPace. With that, I will turn... the call over to Patrick Williams for a review of our financial results and outlook. Patrick?

  17. Management

    Thank you, Joel.

  18. Management

    I will review our third quarter 2026 financial performance in more detail, and then discuss our revised full-year guidance. As a reminder, our former SEEG distribution business is presented as discontinued operations. Unless otherwise noted, the financial results discussed today reflect continuing operations and exclude our former distribution business in both the current and current and comparable prior year periods. Gross margin and operating expenses are discussed on an adjusted non-GAAP basis, excluding stock-based compensation. I will also identify adjusted operating results, net loss, and EBITDA separately. and GAAP results. Reconciliations to the most directly comparable GAAP measures and supplemental historical tables are included in today's earnings release. RNS system revenue was $22.9 million, representing growth of 1.4%. compared with $22.6 million in the third quarter of 2025. Service revenue was $203,000, compared with $771,000 a year ago. The decline in service revenue more than offset the growth in RNS revenue during the quarter. Total revenue in the third quarter was $23.1 million, a decrease of 1.1%, compared with $23.4 million in the prior year period. Adjusted gross margin was 84.8% in the third quarter, compared with 82.8% in the prior year period. An improvement of approximately 200 basis points, driven by better labor absorption. Gap gross margin from continuing operations was 84.3%.

  19. Management

    Total adjusted operating expenses were $19.2 million, compared with $20.7 million in the third quarter of 2025, a decrease of approximately 7%. The decline primarily reflected lower personnel related expenses. including variable compensation. We continue to manage spending carefully while investing in the commercial capabilities, clinical programs, and product development initiatives that support our long-term growth. Adjusted sales and marketing expense was $10.5 million, compared with $10.5 million. with $11.2 million in the prior year period. The decline primarily reflected lower sales and field support personnel costs, including sales commissions, partially offset by increased headcount. Adjusted research and development expense was $5 million. compared with $5.8 million in the prior year period. The decline primarily reflected lower personnel related expenses, including variable compensation expense, partially offset by lower grant funding. As a reminder, grant funds primarily primarily from the National Institute of Health are recognized as reduction in research and development expense. Adjusted general and administrative expense was $3.2 million compared with $3.7 million in the prior year period. The decline primarily reflected lower variable compensation expense partially offset by a higher personnel cost associated with increased headcount. Total stock based compensation was $2.4 million in the quarter, including $2.3 million in operating expense and the balance and cost.

  20. Management

    of goods sold. GAAP operating expenses were $21.6 million. Adjusted income from operations was $0.4 million compared with an adjusted operating loss of $1.4 million in the third quarter of 2025. Adjusted net loss was $0.9 million compared to a loss of $2.3 million a year ago. Adjusted EBITDA was a gain of $0.4 million compared with an adjusted EBITDA loss of $1.3 million in the prior year period. Gap net loss from continuing operations was $3.3 million compared with a loss of $4.9 million in the third quarter of 2025. We ended the quarter with $49.5 million in cash, cash equivalents, short-term investments, and restricted cash. Compared with $51.9 million at the end of the second quarter. Long-term borrowings total $59.2 million as of September 30, 2026. Turning now to our outlook for 2026, we are revising full-year total revenue guidance to $91 million to $92 million. Compared with our previous range of $99.5 million to $101.5 million. This revised range reflects our third quarter performance and prudent expectations for the pace of improvement in the fourth quarter. We continue to expect approximately $1 million of service revenue for the full year. This implies R&S system revenue of approximately $90 million to $91 million, representing full year R&S revenue growth of 10% to 11%. Compared with 2025. Based on revenue for the first nine months, our full year outlook implies fourth quarter total revenue in the range of approximately $23 million to $24 million, with underlying R&S growth of approximately 5% year over.

  21. Management

    year at the midpoint in the fourth quarter. While we have begun to see a recovery in procedure volumes and strengthened execution, our outlook does not assume a return during Q4 to the growth rates reflected in our previous guidance. We are increasing our full year adjusted gross margin outlook to 83% to 83.5% compared with our previous range of 82% to 83%. This reflects the gross margin performance we have delivered year to date and our current expectations. For the fourth quarter, we now expect full year adjusted operating expenses of $85 million to $86 million, a decrease from previous expectations of $90 million to $92 million. This range continues. To exclude approximately $10 million of stock based compensation. Consistent with the drivers discussed in our third quarter results, the revised outlook reflects lower expected variable corporate compensation and sales commission. Our approach remains to allocate resources to the programs that can drive adoption and long term scalable growth while maintaining discipline across the organization. Within that outlook, we expect full year adjusted sales and marketing expense of $45 million to $46 million compared to previous guidance. $46 million to $48 million. These investments support our field organization, physician education, market development and patient referral pathways. Our focus is on improving the productivity and consistency of those investments as we move through.

  22. Management

    The fourth quarter and into 2027. We expect full year adjusted research and development expense of approximately $25 million compared to previous guidance of approximately $27 million. Our investment priorities include. MGE and adolescent indication expansion, remote care, the neuro pace AI suite and our next generation RNS platform. We remain committed to advancing these programs while managing resources against defying development milestones. We expect full-year adjusted general administrative expense of approximately $15 million, compared to previous guidance of approximately $17 million. This reflects the corporate infrastructure and systems required to support the business with continued discipline. Round overhead. Based on the revised revenue gross margin operating expense outlook, we expect a full-year adjusted EBITDA loss of $8.5 million to $9.5 million. We remain focused on balancing investment in the opportunities ahead with financial discipline and progress. Sustainable profitability. Finally, I would like to discuss our expected revenue trajectory as we exit 2026 and move into 2027. As Joel noted, we still remain confident in the durability and long-term growth. potential of our business within our current indication. With IGE and pediatrics ages 12 to 17, offering favorable adoption dynamics and meaningful opportunities to expand our addressable market in 2027 and beyond. We currently expect our

  23. Management

    revenue growth of approximately 10% to 15% year over year in the first half of 2027 as our commercial execution improves, accelerating to 15% to 20% in the second half of 2027. Resulting in full year RNS revenue guidance of approximately 15%. Consistent with Joel's earlier comments, these expectations exclude any contribution from IGE indication expansion and zero contribution from service revenue. And with that, I will turn the call back to Joel.

  24. Joel BeckerChief Executive Officer

    Thank you, Patrick.

  25. We take our commitments to shareholders very seriously, are accountable to them, and recognize that our third quarter revenue results did not meet those commitments. We believe we have identified a number of the factors affecting our performance, and we are acting with urgency to address them. We remain very excited about the market opportunity and the catalysts and growth potential for the business now and for the foreseeable future. The need for better treatment options is substantial. Physician interest in R&S continues to expand and our clinical evidence demonstrates meaningful, durable. Seizure reductions for patients living with drug resistant epilepsy. The quarter has highlighted additional opportunities to improve and strengthen how we operate and scale the company and we are acting on. Those lessons through expanded commercial coverage better patient pipeline information and more consistent planning and execution potential expansion into IGE and adolescent focal epilepsy together with. Remote care and our broader innovation pipeline creates additional opportunities to extend the reach and value of our responsive platform. Our priority is to translate these opportunities into broader. adoption and a return to sustained stronger growth both now and into the future.

  26. Thank you for your time and continued interest in Neuropace. Operator, we are now ready.

  27. Q&A29:08
  28. Operator

    We will now begin the question and answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1. Star 1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you're muted locally, please remember to unmute your device. Please stand by now while we compile the Q&A roster.

  29. Your first questions come from the line of Larry Beigelson with Wells Fargo. Your line is open. Please go ahead.

  30. Question · Wells Fargo

    Ross OsborneAnalyst · Wells Fargo

    This is Ross Osborne on for Larry.

  31. Thanks for taking our questions.

  32. Starting off, is there a path back to 20% growth for R&S? Obviously, second half of next year, you guys talked about getting in 20%, but that's on the EV comp. So just curious, longer term, with the changes you're making, can you- get back to 20% growth? And can you get there without the SCEG business?

  33. Management

    Thanks for your question, Ross.

  34. Management

    I think the short answer is yes. We remain enthusiastic about the market opportunity and the potential within- the indicated patient populations. We're making a number of changes and investments to both improve our current execution as well as expand and deepen coverage within the business. And- We do see a path back to that. We see that it's going to take us some time to round into form on that, and we've reflected that here. But absolutely, we remain convinced and convicted around the- the market potential for the current indications, and that's only supplemented and complemented by the other catalysts that we're working on.

  35. Question · Wells Fargo

    Ross OsborneAnalyst · Wells Fargo

    Okay, great. And then, would you be able to parse out growth, excluding the disrupted accounts? So, maybe outside those larger ones, how the rest of the business is performing, and what gives you confidence, you know, that won't translate into more accounts going forward?

  36. Management

    We can, after a fashion. And what I'll tell you is that a meaningful amount of the disruption that we saw was in the larger accounts. And so there's a couple of dynamics, I think, worth noting there. One, obviously, with a customer concentration like we have, any disruption in those larger accounts has an outside defect. And so a lot of the disruption that we did see was present inside of those accounts. That covered up a couple of other favorable dynamics within our account analysis and sales execution during the quarter. One, we have expanded the number of what we call medium sized accounts that now are the group that we're focused on taking. From what we call good to great. And so we have a positive dynamic there where we have a group that had been kind of samplers and periodic users of the technology that we have moved up to the next tier of customers. And our focus, some of it driven by disruption at some of these larger accounts, has been to expand that group. And we saw good progress in that regard. We have also seen good progress in the ongoing community. Work that we've been doing and the number of patients that are coming from community centers and community referrals. And so both of those dynamics have been positive for us and have supported the business that we did see in Q3. But we're covered up by some of the disruption in the larger accounts. So we're really looking to try and do two things here. Have additional market development execution levers that we are delivering on from

  37. Management

    referral to more patients within the community and level three centers as well as then more centers going from good to great. That has the advantage of diluting the customer concentration impact of any one of the large centers and acts as accomplished. Then to what we see as returning stability and good growth cadence in those larger centers. So we see those things working together. The we're seeing good recovery in the larger accounts. And again, it's not a dynamic. We don't see a dynamic here where people have turned off on RNS. That's not the case. We've got good support within those centers. It's more a stabilization and cadence of procedural volumes and some of the things I mentioned in my prepared comments around capacity and staffing, etc. In those larger accounts, then the recovery there complemented with the development of additional accounts and additional referrals. Thank you.

  38. Management

    Thanks, Ross.

  39. Operator

    Your next question comes from the line of Mike Kratky with Lyrinc Partners. Your line is open. Please go ahead.

  40. Question · Lyrinc Partners

    L

    Hey, everyone.

  41. Thanks for taking our questions here. I think you talked about a meaningful number of changes to your sales force. First, what was the rationale for those decisions? When did you initiate some of those changes? And can you talk about where you stand in the process there? I sure can, Mike. So we took a number of those changes for reasons that we could see where we wanted to both position the business to scale for the future as well as address some places where we could see where we needed higher levels of performance.

  42. Management

    We began those changes at mid-year and really worked through them during the third quarter and there are a number of them here. That I'll review with you, but it's really both of those things. There were changes we needed to make to both position the business to scale for the future as well as execute at a higher level today. And it's had the benefit of really maturing the organization. It has provided us with closer contact with and better visibility into the daily field activity. More and better visibility into real-time pipeline status and a better alignment and ongoing integration with our planning functions. All of that, again, helps us with current execution and scaling going forward. There were really three key areas of changes that we made. One was with regard to our people. They focus on people, processes, and tools. Those are the areas that we focused on here as we look to raise our level on execution and position ourselves for scale. So one from a people perspective, we made changes and I believe are improvements to sales management. We do a number of sales territory leadership roles and changes to our field clinical organization. Let me tell you a little bit about each one of those. From a sales management perspective, we flattened the organization. And put in place a more direct reporting relationship from sales managers to senior sales leadership. Again, more clarity, direct visibility, and agility in terms of taking advantage of opportunities.

  43. Management

    And reacting to initiatives. So that was one. Two, from a sales representative perspective, we made changes to a number of sales territory roles where we could see that we needed improved performance. And we wanted to get the profiles of the people in place, both so we could drive the business today, but also as our catalysts are realized, we're in position to more fully take advantage of those. And then third, with regard to the field clinical organization, we made changes that allowed us to centralize a number of functions that our field clinical organization was performing and provide both greater efficiency for those functions while also allowing us to reallocate former field clinical engineering technical support requirements into more sales-focused roles. So, as a result, as we... with regard to where we're at with that, the field clinical structural changes are complete, the territory representative changes, that group of changes that we made are also complete, and the sales leadership changes. are complete. We are planning additional investment in our commercial organization, and we're planning that investment in 2027, but those are really designed to add. Add to the organization and bring both a deeper level of account focus and broader coverage both within our traditional level four customers and the community referring and pipeline part of the of the commercial organization. So those are the reasons we.

  44. Management

    Made them the changes that we made and where we're at in it. Does that answer your question, Mike?

  45. Management

    Yeah, yeah, I mean, yeah, it's helpful. Maybe to take a step back. Yeah, you called out kind of a few reasons for for the revision in terms of your second half performance and how to think about growth for next year. So, you know, is there a way to kind of parse out between the different headwinds that you laid out with your own internal changes, some of the external? You know, how much of the disruption came from each of those different factors? Yeah, let me let me let me try and and say a little bit more about that. I think of the three key things that we laid out. The local market dynamics and factors in some of the big accounts, some of the Salesforce disruption and then the transition through the SEG timing. I'd say we're probably furthest through the transition with SEG. You know, that was that was something that, you know, it takes a little bit to work through that, but we've really seen those accounts now responding and performing much in line with the rest of the accounts. With regard to Salesforce disruption, I think I just kind of walked you through that.

  46. Management

    We're largely done with that. The people are in place. It's now a matter of really, again, kind of rounding that all into form and then continuing to add to and invest to further accelerate. The business. With regard to the local market factors, that's probably the trailing edge of it for now. And we're seeing stabilization and in Q4, a good return to growth from procedural volumes. But we're, as we mentioned in our... Prepare comments. We're taking a prudent look at Q4 and wanting to make sure that that cadence is consistent and that we're seeing the momentum that we're looking for in those local market factors. So that kind of... It'd be the one, two, three that I'd give you. Patrick, would you have anything to add to that? Well, I think obviously these are fair questions after we put up a quarter that was, you know, disappointing, certainly internally for us. And, you know, we... We've been thinking about making these changes on the sales infrastructure, and it really comes down to being able to scale. And as we took a step back and thought about what was on the horizon for us, like IGE coming in 27, pediatrics on the heels of... We've got some really good products, obviously, with ECOG assistance that's out there and then remote monitoring. We wanted to make sure that we had the sales force in place and ready to go. And so, clearly, it was more disruptive than we thought. We saw a big disruption in the major accounts.

  47. Management

    We already talked about that we're a little over indexed in terms of our top accounts that drive a big part of our revenue. And so, we learned a lot during the quarter. We started dissecting, obviously, as we started moving towards the last month of Q3. We continue to look at it on a daily basis, as you can imagine. And so, there's a lot of eyes on this, but what we saw was a need, as we said in our prepared comments, to invest more in quota-carrying reps. And what we're going to do is, in terms of some of these large... ... accounts, you can imagine we're going to have more of a focus on that, so we can go deeper within those, bring them back up to where they were historically. We're doing well in the smaller mid-accounts, we'll call it, and so we're going to make a meaningful investment... on the sales team in order to correct this. And as I said, I think those decisions are never easy to do, but we believe this is the right move for us as we scale forward, especially what's on the horizon with IGE and pediatrics.

  48. Management

    Okay. Thanks.

  49. Operator

    Your next question comes from the line of Anthony Patron with Mizuho. Your line is open. Please go ahead.

  50. Question · Mizuho

    Anthony PatronAnalyst · Mizuho

    Thanks for taking a question.

  51. Good afternoon, everyone. Maybe on, you know, specifically prepared comments, Joel, in terms of, you know, a handful of large accounts that add several issues, staffing, physician availability, diagnostic capability at that, for that particular headwind, you know, were those patients pushed out into the surgical calendar or were those procedures lost? So that would be my first question. And then when you think about the Salesforce disruption, were there any accounts, I guess, that were completely lost and that, you know, with the Salesforce restructure, you'll have to essentially go back out there, knock on doors and get those accounts back. And then I'll have one follow up with regards to, thank you Anthony. With regard to the large accounts, we feel like the majority of those patients are pushed out, not permanently lost. And so, again, it takes some time to work them through the pipeline, but we feel like, again, the level of enthusiasm and support for RNS is there, and it's really a matter of getting the... Capacity and the throughput back up in those accounts, and we're seeing, again, we're seeing recovery and watching and working hard on that process. With regard to the restructuring of the sales force... We haven't really seen where we've lost accounts. It's more the transition of people in and out of roles, getting clarity, people getting insights and effectiveness in new roles, etc.

  52. So, we have... We haven't seen where the restructuring has caused us to lose customer support. Now we have to try and go out and replace those accounts. It's more the transient nature of reallocation of roles and moving people around and having them get... comfortable in those roles. That's helpful. And then maybe just on the, you know, the FDA comments mentioned that, you know, there'll be a resubmission with additional analyses. The FDA has basically requested here for the amended PMA supplement package. And so, you know, maybe just a little bit of detail on specifically what type of analyses they're looking for, you know, to what extent does longer term data. Resonate with FDA, because certainly that has been good with R&S, and again, just the confidence here that we could see a resubmission by the beginning of the year, you're keeping the mid-2027 target intact. So just a little bit about any specifics that FDA is looking for and the level of competence that we are on track for another 2027 submission. Thanks.

  53. Management

    Thank you, Anthony.

  54. Question · Mizuho

    Anthony PatronAnalyst · Mizuho

    I have a lot of confidence. We're on track for an early 2027 submission. I want to be clear about that. I feel very good about that. With regard to the meeting itself, you know, we had an in-depth discussion really with a focus on the data and the qualitative measures. of benefit. So what are the nature, what is the nature of the clinical meaningfulness of the improvement in the data? And that discussion included perspectives from both physicians, epileptologists, as well as functional neurosurgeons and from patients. And I think that was helpful in having them also express their perspective on the impact of RNS therapy. The discussion helped us. With regard to specifically understanding the statistical analysis that the agency wants as part of the resubmission and how they would like to see us address those requests in the amendment. So I think we walked away with greater clarity. On the work to do, we feel confident in the totality of the evidence approach that we're taking with regard to RNS. And we think that the planning of 180 day review while it may not take that long is appropriate. And feel like the submission around the beginning of the year, we have a lot of confidence in. Yeah, we try to be thoughtful and I got to follow up in there. We try to be thoughtful on you know, we gave the guidance certainly for Q4. I know everyone's got to digest all of it and we wanted to give some color around 2027. Just a reminder again that the numbers that we gave out there of about a 10 to 15% in the first

  55. Management

    half 15 to 20% in the second half of 27 do not include any contribution from IGE. There's a little bit of service revenue that we also did not include in there. So again, you know, we feel like we're in a good spot still, but we're working through and wanted to be and about how we were setting expectations, especially after coming off of what was a very disappointing Q3.

  56. Operator

    Your next question comes from the line of Brett Fishpin with KeyBank Capital Markets. Your line is open. Please go.

  57. Question · KeyBanc Capital Markets

    Go ahead.

  58. Hey, guys.

  59. Oh, thank you so much.

  60. Thanks for taking the questions.

  61. Maybe just following on some of the previous comments about, you know, the 4Q guidance and, you know, framing it as prudent. I was hoping you could just expand a little bit there on level of visibility. into the implied RNS growth range for next quarter. And then maybe specifically, like, how much further improvement you'd need to see around some of the 3Q headwinds in the last six weeks of the year to really achieve that level of revenue. Yeah, I'll take that one. And so, again, you know, we started seeing some issues in the Q3 number as we exited Q3. That's why you're seeing the overall guidance drop beyond the myths that we had in Q3. What I... I can tell you is, you know, kind of being a little bit of a broken record here, but all of those structural changes are done. We are going to be adding heads. We think that's the right thing to do as we move into 2027 to get anyone prepped, especially on the Salesforce side with the... expanded indications that we're going to have. But again, we were bearing what we think is very prudent in terms of what our first half growth will look like. And so not sure how else to answer it other than, you know, we're being thoughtful about this and we've got... enhanced capabilities and visibility into how we're thinking about the patient pipeline. And we've obviously made some changes to make sure that we're staying very close to that. Joel talked about the flattened structure on the sales side, but there's a lot of...

  62. Management

    ...of engagement on my side of the world. And so I would just say that the numbers we put out there, we're feeling good about those, and we've taken that all into account.

  63. Management

    All right, great. And then just my second question, you know, the... Aurora real world evidence study that, you know, you talked about today. So it seems like you're indicating that the data submission will be collected by early 27 around the real world patients. And just curious, you know, how collaborative, you know, this process has been with the FDA and trying to understand if, you know, leaning on a real world study, you know, and submitting the data will be enough to realistically get that expanded indication for patients in that 12 to seven. range.

  64. Management

    Thank you so much.

  65. Management

    It's a great question.

  66. Management

    Thank you, Brett.

  67. Management

    The process has been very collaborative. The agency has a whole group of people looking at real world evidence and how that evidence can be used, different potential patient indications. We're looking at a variety of different ways to use that with regard to submission now, but we've been pleased with, and we'll see how those work out, but we've been pleased with the level of collaboration and engagement, and we're excited about Aurora and the progress we've made here since starting enrollment. So more to come on that, but it's been a good collaborative process thus far. Yeah, and I think we noted it in there that the difference between this and sort of a standard clinical trial is that you do a lot of the work up front, which allows for potentially a quicker approval process at the end of review process with the FDA. So that's why we talked about potentially 2027 approval for the 12 to 17-year-old age group or in early 2028.

  68. Management

    Thank you so much.

  69. Operator

    Your next question comes from the line of Lily.

  70. Question

    ?
    LilyAnalyst

    Zada with J.P. Morgan. Your line is open. Please go ahead. Hi, thanks for taking the question. I'm hoping you can unpack these challenges a little bit more. It sounds like it was. Several isolated headwinds, but then happening all at once is a little bit confusing. So was there anything tying these events together or something that prompted all this to occur? You had been on. Such a strong trajectory this year. So it's just surprising to see that reverse all of a sudden. And what gives you the confidence that it's not a broader market or demand challenge?

  71. Management

    Thanks for the question, Lily.

  72. Management

    I think, again, if you go back and look at these factors, number one, the local market factors discussion really is it's a really an offshoot of customer concentration. And so when you have, you know, a group of accounts that have a high percentage of the volume. When you see any kind of a change in the cadence and run rate within those accounts during the same time period, it can have a significant effect. Again, we, we don't. I think we do think those are transient types of issues. And it's, and there were not consistent issues between the large accounts. So it's not like any individual account kind of metastasized in effect any. But there were just local, that's why we chose the terms local factors that impacted a customer concentration and the cadence within the period. And it's not more complex than that. The second, the sales force disruption during the period of time where those local market. factors were happening. We also made changes and so those are coincident. We made changes that we both felt like we needed to perform at a higher level today and we are now in a much stronger position from a commercial execution perspective but that occurred at the same time we were seeing those impacts and then by virtue of exiting the SCEG business at the beginning of the year it takes a period of time for that case flow to work its way through the diagnostic process and it kind of lands at the end of Q2 and into Q3 and so we don't see a broader dynamic of

  73. Management

    you know has somebody really gotten a leg up from a technology perspective or has there been some data that's come out or anything else in fact you know we feel really good about where we're at from a data perspective we feel really good about where the pipeline is as we look toward 27 and with regard to indication expansion so we we don't think that you know we do think these things are transient we don't think there's anything that's as consistent other than when you have disruptions like this, it can open the opportunity for others to come in and pick off cases around the edges. And so there there can be some competitive activity during periods of disruption like that from in particular from an internal organizational perspective that we expect to tighten up here as as people are in role and and we're more in place with the organization now as we as we execute. Q3 and into Q4. yeah the only thing I would add is and we talked about it but I know there's a lot to digest here is the large accounts also where some of our highest SCEG or the old Dixie business and so Joel just walked through that and so as we moved some folks around and restructured clearly that had probably an over impact for us in Q3. One of the reasons why again that we talked about that we are investing more into field sales people is to make sure that we've got good coverage in these large accounts to make sure we're there on a more present day in and day out basis and so again we have a solution to address this and that is the solution and it's a contemplated in certainly our Q4 and our first half 27 where you don't see us getting all the way back up

  74. Management

    to that 20% on the current focal indication. Great that's all very helpful and then just as a follow up on 2027 can you unpack some of the assumptions underpinning this preliminary outlook. With R&S growth of about 5% in the fourth quarter of this year, what drives the step up next year and what gives you the confidence in that acceleration this early on, especially as you face tougher costs in the first half of the year?

  75. Management

    Thanks so much.

  76. Management

    Yeah, and we're going to get this question a lot and ultimately we have to perform and get back to that high say-do ratio as we like to say. So what I can tell you is we took a step back and made sure we understood. what we believed we could do. We do have all of the changes in place related to the restructuring. People are clear about their roles and responsibilities as we move things around. We've changed the sales management again. We will be onboarding quite a few sales. Those people, quota-carrying folks here as we exit the year into 27 and so all of those things give us the benefit and the confidence that we'll start getting back to where we're at. But again, I think we try to take a prudent approach. to this. We're not talking about getting back up to 20% on January 1st. We wanted to make sure that we're being thoughtful about how we do this, but we appreciate we will continue to get these questions until we start proving out and show growth again as soon. Q4.

  77. Operator

    Your next question comes from the line of Mike Pollark with Wolf Research. Your line is open.

  78. Please go ahead.

  79. Question · Wolfe Research

    Thank you.

  80. Good afternoon.

  81. On the topic of competition, Vegas nerve stimulation this year has a generational reimbursement increase for both new and replacement patients. As I digest all of the comments tonight, you know, the customer concentration... Very prolific centers sound impactful in the myths and guide down. Can you attribute any of it to the incremental economic appeal that VNS has experienced this year that makes some sense to me? I know the patients are often different, but... There is some overlap. It is a procedure with less workup, and now there's a ton more dollars attached to it. I'd be curious for your perspective on this dynamic.

  82. Joel BeckerChief Executive Officer

    Thanks, Mike.

  83. It's a good point. And as you mentioned, you know, positive reimbursement can certainly have a positive effect in some centers and depending on their individual reimbursement levels. As you also mentioned, there are some sub-segments in which we compete more directly and in others where we don't. And so there's a part of the market where we don't have as directly visible perspective. In the places where we do compete directly, you know, obviously it's a benefit for them to have an increase in reimbursement. We don't hear where we are losing competitive. Market share head to head based on that reimbursement change. I think there are other patient and data specific factors that people are considering, but obviously it would be to their advantage to have an increase from a reimbursement perspective. Joel?

  84. Question · Wolfe Research

    Thank you Joel.

  85. Management

    My follow-up topic is on Dixie. If I go back to the decision to exit, one of the mentions was just it required a lot of rep time to solve the problem. And, and tonight I heard, you know, amongst the mentions was, you know, we're not getting those neurosurgeon touch points without Dixie and maybe some of the upstream visibility is reduced. I'm not asking you to cry over spilled milk. It's water under bridge, but could you get Dixie back? Is that a course that could make sense? Thank you. Let me maybe start with the neurosurgeon access point. And I think as you rightly know, we noted at the time of the exit of that business that we felt like, well, it was helpful that we had developed relationships there. And that we would continue to have access to those call points. And we feel like we do. And we feel like that has been transitioned well. I think what we've learned here is that the presence of the distribution of the product line gave a more routine presence and engagement structurally. And we just we needed to make the point here and make the commercial organization more present to take advantage of the relationships that were built in the call points that are there for us. And it was more of a of an attention to the fact. That having the ongoing presence there can allow you to either pick up or not a case or two around the edges. And so that's really the corrective action that was taken, which has resulted in the normalization of the performance.

  86. Management

    And those accounts that we mentioned. And so, again, we think it was one of the transient aspects of we transitioned the customers well, customers were happy with the transition, etc. That all went according to plan. A nuance was the picking up. or not of cases as a result of being there on a more ongoing basis. And now, because we do have the call point in the relationships and we are, we have fixed that level of attention from a sales behavior perspective, we feel like we're in good spot there. So we don't need to be. In the SCEG business. That's not a comment on whether we wouldn't want to be in the SCEG business or whether we think that is a potential force or not going forward. I, the calculus remains that. The sales rep time here is going to be getting more and more valuable as we think about indication expansion coming. And with some of the delays here with IGE, that's been a little bit forestalled. But that remains the case as well as with our own product development pipeline here now beginning to put products out with ECOG Assistant and now with remote care coming in 2027 as well. We've got plenty that's coming that are going to be both good catalysts for the business as well as things for our folks to continue to take advantage of with regard to new products and indications and working up the new referral stream too. We've addressed the SEG topic. That's not to say never, you know, never say never, but it's not something that we need to have.

  87. Operator

    We have now reached the end of the Q&A. I will turn the call back to Joel Becker for a closing statement. Please go ahead.

  88. Joel BeckerChief Executive Officer

    Thank you. Just a few closing comments. As I mentioned at the outset, I am accountable for and I take very serious significantly the disappointing revenue results here in Q3. I think about our owners and the people who follow NeuroPace every day. We are very focused on near term commercial execution and we are in a stronger position to do so today. And we are underway with additional investment as well and we have mentioned. We continue to see significant market opportunity for R&S and we have made improvements in our people, tools, and processes to both improve that immediate term execution and prepare to scale the company for what's coming in terms of catalysts. I'm very excited about where the business is headed. We're making good progress on those catalysts, advancing IGE, submitting remote care ahead of schedule, as well as with Aurora and others that are now in full swing. Some of you would remember when I first laid out. Our strategy and long-range plan at our investor day back in January of 2025. That strategy remains intact. As a reminder, I said then, I grew up in the cardiac world, and I feel about the brain today the way I felt about the left atrium and the left ventricle in 1995. The brain is the next frontier for medical technology, and the arm is the next frontier for medical technology. The KRNES system is the only closed loop neuromodulation system, and we have multiple clinical product and market development initiatives underway that provide potential growth catalysts.

  89. We are uniquely well positioned to lead in the development of epilepsy and beyond. We are executing and making good progress on this strategy. I am even further convinced of these things today, and we're in an even stronger position. To execute on them today, we are laser-focused on immediate-term commercial execution and continuing to advance the catalyst that will provide ongoing and longer-term growth opportunities for NeuroPace.

  90. Thank you all. All for your ongoing interest in and support of NeuroPace, thank you to the NeuroPace team for all of your hard work and commitment, and I look forward to updating you all on our progress.

  91. Operator

    This concludes today's call.

  92. Thank you for attending.

  93. Operator

    You may now disconnect.

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