Good afternoon, and welcome to NeuroPace’s Fourth Quarter and Year-End 2023 Earnings Conference Call. As a reminder, this conference is being recorded. I would now like to turn the call over to Jeremy Feffer from LifeSci Advisors for a few introductory comments.

Good afternoon. Thank you for joining us for NeuroPace’s fourth quarter and year-end 2023 financial and operating results conference call. On today’s call, we will hear from Joel Becker, Chief Executive Officer; and Rebecca Kuhn, Chief Financial Officer. Earlier today, NeuroPace released financial results for the fourth quarter and year-ended December 31, 2023. A copy of the press release is available on the company’s website at neuropace.com. Before we begin, I would like to remind you that throughout this call, we will make statements that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. All forward-looking statements, including those around NeuroPace’s projections, business opportunities, commercial expansion, market conditions, clinical trials and those relating to our operating trends and future financial performance, expense management, estimates of market opportunity and forecasted market and revenue growth are based on current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For more detailed descriptions of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings with the SEC, including our recent quarterly reports on Form 10-Q, annual report on Form 10-K for the year ended December 31, 2023, 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 March 5, 2024. 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. With that, I will now turn the call over to NeuroPace’s Chief Executive Officer, Joel Becker. Joel?

Thank you, Jeremy, and good afternoon, everyone. As you saw in the fourth quarter press release issued earlier today, the NeuroPace team has continued to execute on our strategy and delivered another strong quarter to cap off what has been an outstanding year. Revenue for the fourth quarter was $18 million, a 41% increase compared to the same period last year. For the full year 2023, we reported total revenue of $65.4 million, a 44% increase over 2022. As we look back to where the company was just a year ago, we’ve continually raised the bar and exceeded expectations. I am proud of everyone on the team and all that was accomplished in 2023 and look forward to capitalizing on this momentum in 2024. With that, let me step back and provide some additional color around what drove our top line results in the fourth quarter and full year 2023. I will then review our key business priorities for 2024 before turning the call over to our CFO, Rebecca Kuhn, to present the details of financial performance for the quarter and year ended December 31, 2023, which will be followed by a Q&A session. In 2023, we developed and worked to execute our three-part strategy to expand access to and increase adoption and utilization of RNS therapy for drug-resistant epilepsy patients that support our current near-term and medium-term growth plans, across existing and new groups of clinicians as well as patients. These plans are aligned with the International League Against Epilepsy or ILAE, which published new guidelines in 2022, stating that once a patient has tried and failed medications, they should be referred for additional treatment even if surgical intervention is not appropriate. We believe RNS fits exactly in that category. Turning to our three-part strategy for expanding access to and developing the market for our RNS system. The first part of our strategy, which is in motion now, is focused on the Level 4 Comprehensive Epilepsy Centers or CECs, and is aimed at driving adoption across clinicians and expanded therapy utilization by current prescribers under what we call the modern RNS story. This approach aims to stimulate our existing base of customers at Level 4 epilepsy centers through education and support on how RNS can be used to treat a broad range of patients with drug-resistant focal epilepsy through traditional focal stimulation approaches, treatment with a network stimulation approach, and utilization of RNS as a hybrid therapy with surgery, meaning either in conjunction with surgery or by utilizing RNS to help inform a subsequent surgery. The modern RNS story also involves highlighting the improvements in ease of use and efficiency we have made with the RNS platform. We are pleased with the momentum of these efforts within our Level 4 centers, and it has driven much of our RNS system growth in 2023. The second part of our strategy, which we call Project CARE, will be an area of focus in 2024 and provides an opportunity to expand access to our RNS system outside of Level 4 CECs. This expanded access has the potential to allow for appropriate patients who could not or would not have been referred to a Level 4 Center for Care to be treated closer to home and also provides the opportunity for patients to be identified and referred to Level 4 centers. This new approach is now possible due to the FDA approval of a PMA supplement in 2023, which opened up our ability to access the approximately 1,800 additional epileptologists and the remaining functional neurosurgeons to prescribe and implant the RNS system within the currently approved labeled indication. We are planning to initiate this pilot program outside of Level 4 centers during the first half of 2024, and some of these activities have begun. While early in our process of initiating pilot program activities, we have been pleased with the interactions with a number of our initial target centers regarding the potential for appropriately indicated patients to be treated locally as well as in the identification of potential RNS patients who should be referred to Level 4 centers for evaluation. In support of the growth that we have seen with the RNS system and Level 4 centers, as well as in order to ensure the proper support for Project CARE, we have begun making incremental additions to our sales and support teams and are pleased with the skill sets and experiences of the representatives we have hired and that we are seeing express interest in joining the NeuroPace team. The third phase of our RNS strategy is based on expanding the improved indications for the RNS system. This effort is currently focused on the pivotal NAUTILUS study, which completed enrollment and subsequently the number of implants required for FDA submission during the fourth quarter of 2023. We believe that the pace of enrollment and implants in the study reflects the significant unmet need that exists for patients with drug refractory idiopathic generalized epilepsy. As a reminder, the NAUTILUS trial requires evaluation of a primary safety endpoint and an effectiveness evaluation 12 months post-implant. If approved, our RNS system would be the first device with an FDA-approved indication for generalized epilepsy. This study has the potential to represent a highly meaningful market expansion opportunity. Additionally, in 2024, we plan research and development work on software tools, leveraging our data and AI analysis capabilities designed to enhance clinical insights as well as patient support efficiency and ease of use. As we take a deeper look at our financial and operating performance for the fourth quarter of 2023, revenue growth was primarily driven by sales of our RNS system. The growth from new RNS system sales was partially offset by continued decline of RNS replacement implant revenue. As I've mentioned on previous calls, we expected this decline to occur as most patients with the older version of the RNS device have already had their devices replaced with the newer version. Also, we continue to see revenue growth from our exclusive partnership with DIXI Medical to market and sell their diagnostic electrodes and related products for epilepsy. As a reminder, these products are used to determine where epileptic seizures originate. Physicians use this information to target interventional treatments at the seizure source, including with our RNS System. While we do not plan to break out revenue components on an ongoing basis, the contribution from the DIXI partnership to our top line performance remains at approximately 15% of total revenue. This is a highly complementary product offering to the RNS System that leverages our existing commercial team and customer base and provides earlier visibility into the pipeline of patients that may be appropriate candidates for RNS therapy. As we review our performance, we continue to be pleased with the progress made in 2023. The strategy we put in place is focused on clinician and patient needs and leverages our differentiated technology and organization. As a result, we have been able to execute our commercial strategy while maintaining disciplined expense management, resulting in cash burn in the fourth quarter of 2023 of $3.4 million, compared to $7.9 million in the fourth quarter of 2022. With regard to the new opportunities we've recently announced, we have entered into a first-of-its-kind strategic collaboration with a biotechnology company, which will leverage our RNS System's unique biomarker monitoring and data analysis capabilities. The collaboration will evaluate biomarker changes in currently implanted RNS System patients that have enrolled in the biotech company's Phase 2a proof-of-concept trial of its product candidate. We believe this groundbreaking collaboration is another example of the value that our RNS system can provide through its proven ability to collect and analyze data, which is then used to generate insights that can help inform treatment strategies. We expect to receive total revenue from this collaboration of approximately $3.7 million. The agreement is broken out into four phases through the fourth quarter of 2025 with certain milestones correlating to each phase, the majority of which are planned to be completed prior to the end of 2024. Now turning to 2024, the NeuroPace team and I will continue to focus on increasing revenue growth, gross margin improvement and operating expense management. Currently, we are expecting to report between $73 million and $77 million in revenue for the full year 2024, which represents a 12% to 18% increase in revenue compared to 2023, driven by the execution of our strategies. We look forward to keeping you apprised of our progress. With that, I will now turn the call over to Rebecca to review our fourth quarter and 2023 financial results, along with some additional detail around our 2024 financial plans.

Thank you, Joel. NeuroPace revenue for the fourth quarter of 2023 was $18 million, representing growth of 41% compared to $12.8 million for the fourth quarter of 2022 and approximately 10% compared to $16.4 million in the third quarter of 2023. This growth was primarily driven by increased sales of our RNS System. We also generated meaningful revenue from sales of DIXI Medical products in our first full year of serving DIXI Medical's exclusive U.S. distributor. DIXI contributed a small amount of revenue to the fourth quarter of 2022. The replacement implant revenue continued to decline compared to the same period last year and represented approximately 4% of total revenue. Gross margin for the fourth quarter of 2023 was 75.2% compared to 68.8% in the fourth quarter of 2022 and 74.5% in the third quarter of 2023. Our gross margin for the quarter increased primarily due to the increase in RNS products produced and sold as our fixed manufacturing overhead costs were spread over more units. The increase in RNS gross margin was partially offset by the lower gross margin from distribution of DIXI Medical products. R&D expense in the fourth quarter of 2023 was $5.4 million compared with $5.1 million in the same period of 2022. This increase was primarily driven by an increase in personnel-related expenses. SG&A expense in the fourth quarter of 2023 was $13.2 million compared with $13.6 million in the prior year period. The decrease in SG&A was primarily due to a decrease in insurance and outside services expense, partially offset by an increase in personnel-related expenses. Total operating expenses in the fourth quarter of 2023 were $18.6 million, compared with $18.7 million in the same period of the prior year. This decrease reflects our focus on finding the appropriate resource allocation to effectively manage our cash, which we are committed to continuing as we move into 2024. Our key focus is on maintaining a balance of managing our operating expenses without compromising revenue growth. Loss from operations was $5.1 million in the fourth quarter of 2023 compared with $9.9 million in the prior year period. We recorded $2.2 million of interest expense in the fourth quarter compared to $1.9 million in the prior year period. Net loss was $6.2 million for the fourth quarter of 2023 compared with $11.1 million in the fourth quarter of 2022. Our cash burn in the fourth quarter of 2023 was $3.4 million. Our cash in short-term investments balance as of December 31, 2023 was $66.5 million. Our long-term borrowings totaled $57 million as of December 31, 2023 with the full principal due on September 30, 2025. As we look ahead, we expect full year 2024 revenue to increase by approximately 12% to 18% to a range of $73 million to $77 million. We expect this growth will be mostly driven by an increase in sales of our RNS System with growth from sales of DIXI Medical products continuing to make a meaningful contribution. We expect our gross margin to be in a range of 72% to 74% for 2024, although we may see small variability due to fluctuations in the proportion of DIXI Medical revenue to overall revenue and other factors. We expect operating expenses for 2024 to range between $80 million and $84 million, including approximately $12 million in stock-based compensation and non-cash expense. I would now like to turn the call back over to Joel for closing remarks.

Thank you, Rebecca. We are very excited by the progress we've been making over the past year at NeuroPace. We believe that our strategy is clear and that our opportunities are compelling. Consistent with our 2024 guidance we believe we are positioned to achieve 2024 revenue of between $73 million to $77 million, and are also positioned to accelerate our growth in the future as these opportunities develop. 2024 will be a year focused on the execution of the strategy, and the entire NeuroPace team is committed to advancing each of its elements to deliver on their potential and to drive long-term growth and profitability. This concludes our prepared remarks. I would now like to turn the call over to the operator, who will open the call for questions.

Thank you. Your first question comes from Frank Takkinen from Lake Street Capital Markets. Your line is now open.

Great. Thanks for taking the question. Congrats on all the progress. I was hoping to start with one on the guide for the year. Obviously, you guys had a very nice year in 2023 with 44% growth, did a nice job of keeping expectations in check throughout the year. Looking forward, looking at 12% to 18% growth, looks like pretty solid growth. But I was curious if there's an element of conservatism baked into that just as we're early in the year and understanding the market dynamics for 2024 and what are some of the elements that are assumed in the low end of the guidance range and some of the elements assumed on the high end of the guidance range?

Hello, Frank. Thank you and thanks for that question. So our guidance, as you said for 2024 is $73 million to $77 million, which implies double-digit growth for the business, the midpoint there of 75%, 15% growth, and we're comfortable with that guidance. We are obviously at the beginning of the year with our guidance, and there are a number of opportunities. I talked about them in my comments here in front of us. We feel like we've got a clear and compelling strategy with the modern RNS story. We're excited about Project CARE. We're underway with our incremental sales force expansion. So we think those are all opportunities in front of us. We've also – there are also challenges in the year but we're excited about 2024. We sit here in March. We're excited about 2024 in the strategies and plans that we've got for the year. Some considerations when we think about the growth in the year and some things within the range there, but kind of some things as we think about, as you mentioned, 2023 versus 2024. In 2023, our growth was primarily driven by sales of the RNS System. It was also bolstered by having a full year of distribution of DIXI medical products there compared to we only had one quarter with DIXI Q4 in 2022, where that only contributed $1.6 million in revenue. And so that bolstered 2023 and then we obviously had the replacement volume dynamic that we've talked about really more in the first half of 2023 than the second half of 2023. But that being a factor as well and then some of the implants associated with the NAUTILUS trial as well. Those factors were all considered in setting our guidance for 2024. And despite a number of those dynamics, results in plans for the double-digit growth in the business. So we think we've got some clear opportunities in front of us that we're excited about. And we think portend well and then some challenges to overcome as well, but we've rolled that all into the guidance as well. I would just mention too, I think – and this wasn't specifically what you asked, Frank, with regard to 2024, but just you asked a question that can – to give some perspective around the business. I would also add that as we talk about 2024, we're here at a point in time. It's obviously a very important point in time and we're executing around it. But I'd also like to point out, as I mentioned in my earlier comments as well, where we're positioned in the business, I think as we look into the future. When we look at the business we're a leader in the space. We've got differentiated technology and data, growth in our core business and our distributed products. Market development plans here initiated with Project CARE, our indication expansion plans for the RNS System with idiopathic epilepsy with NAUTILUS and then the incremental expansion of the commercial organization that I mentioned along with demonstrating operating discipline and a strong cash position. So we think as we look into the future, we believe this positions us to accelerate our growth as well. And I guess just to kind of got a little bit of a head of steam up there. But with regard to closing out talking about 2024, again, so as you mentioned we're comfortable with the guidance for 2024. We're here at the start of the year. We think there's a number of really good opportunities in front of us as well as some challenges, but we're excited about the year in the plans that we've got for the year. And I've tried to make the point in the past, what I'm focused on, what the team is focused on. I think what people have seen from us is that we're in the business of delivering consistent, repeatable results, and that's what we're focused on and executing around.

Got it. That's great color. I appreciate all of that. Maybe just as a follow-up on the sales organization, I heard the comments a couple of times in response as well as the prepared remarks about adding a few incremental sales reps. Can you level set us where that sales organization stands today and how you're thinking about adding? Is it new territories? Are you splitting territories or any other color you can provide about the incremental sales rep additions? Thank you.

That's a great question. Thank you, Frank. So I think we've talked about previously, there's really a couple of phases here to the commercial organization expansion. We've talked about – that I'd want to highlight here. We've talked about in the past that we actually had previously invested in our commercial organization as well. So actually in 2022, we had done some hiring and some commercial organization expansion for which those folks have been going through training and are now getting out into the field and beginning to hit their stride. So we've got that kind of that first wave of commercial investment that we had done previously. And now we are underway with the hiring here that we're talking about today, the incremental expansion of the sales organization. And it's really focused both on to support the ongoing growth that we've seen in the core business as well as to support in anticipation of the initiation of our activities for Project CARE and the sites that will be outside of Level 4 centers.

Got it. That's great color. Thanks for taking the questions.

Thank you, Frank.

Hey. Good afternoon and thanks for taking the questions, and congrats to a solid end to the year. So I had two, I'll start with the first one. You described some of the initial activities with regards to Project CARE; can you maybe describe them in a little bit more detail and what's planned for the rest of the year? And then I have a follow-up.

You bet. Hello, Vik and thank you for that question. So with regard to Project CARE, while we're early here in the process, we have begun to initiate some pilot program activities, including initial outreach to targeted centers. Some of the contracting and various approval activities as well as some of the professional education as well as more site-specific initial training activities, it is still early but a number of those types of activities are underway with some of these centers.

Got it. Will keep add the details, I guess. And for my follow-up question, congrats on the cash burn for Q4. I'm just wondering how we should think about that for 2024? Thank you.

Sure. So with regard to our cash burn, as Joel mentioned, we reduced it to $3.4 million in the fourth quarter. We've shared previously that we do see some fluctuations quarter-to-quarter. But generally we've reduced it considerably throughout the year. We're not going to specifically give you numbers for next year, but you can go through our guidance and come up with a pretty good idea of expectations. And so I think we'll leave it at that. Anything you would add, Joel.

No.

Okay. Great.

Hi, Joel. Hi, Rebecca. Thanks for taking the questions. Maybe just to go back to guidance, I know it’s been touched on a few times, but I was just hoping that you could help put a finer point on what you're building in for underlying new implant growth for 2024 because when I look back at 2023, some of the numbers that you gave, new implant growth was probably close to 50% year-over-year. You also kind of talked about that you’re absorbing some of the RNS implants from the NAUTILUS trial there. So just to help us kind of parse out like what’s being built in from an underlying utilization or new account metric perspective for your 2024 guide for RNS?

Thanks, Drew. That’s a great question. We do see underlying growth here from RNS implants and really being driven off of the modern RNS story strategy that we had talked about. We see growth coming from initial implant sales from RNS as well as growth from DIXI. So we see growth across both of the product lines. And as I mentioned, when you see the growth that’s in the guidance, that growth has to overcome the impact of the NAUTILUS implants in 2023, the net change of the further diminishment of the replacement units and then that DIXI impact of full year distribution. So we do see growth across both product lines. We see growth across both those product lines that results in the double digits that we’ve got here in the guide. We’re not breaking it out product line by product line. But we do see strong growth from both of the product lines making up the point here in the guidance and needing to overcome some of those dynamics from 2023. I know that’s not a fulminant answer to the specifics of maybe you want me to do a calculation for you for how we get there. But those are some of the ins and the outs, the underlying organic growth rate associated with adoption and utilization in our core centers and then the activities that we have underway to both expand adoption and utilization as well as initiate activities for project here and expansion of DIXI revenue then kind of being offset by some of those other dynamics that I mentioned.

Okay. But bottom line, you’re feeling good about growing off like around the $52 million you did in initial implants for 2023.

We see initial implant revenue from RNS systems as an area of growth for us in 2024.

Okay. Great. And then just on DIXI and I appreciate you’re not going to give us like all the refinery detail that we all desire. But just as you are thinking about 2024, just give us a sense of are you expanding DIXI with existing customers? Have you kind of really spread that out around all the accounts that you had just for RNS. And I guess I’m just trying to get a sense of like where you are in the commercial progress, distribution progress for the product line. Thanks for taking the questions, Joel.

Thank you, Drew. And it’s another great question. And with regard to DIXI, I think we see opportunities really across the product line with DIXI. And by that, I mean I think we see opportunities to – through service and support and through talking with centers about the modern approach to managing epilepsy patients and the use of RNS, Phase 2 monitoring being an important part of that. And so deepening the growth of SEEG electrode use in Level 4 centers is an opportunity for us to grow that part of our business even with current customers, one. Two, we absolutely see the opportunity for us to expand the base of our customer footprint. One of the opportunities associated with the distribution deal like this one is, of course, to leverage our commercial organization, and we do feel like there is an opportunity to both competitively as well as then in introducing SEEG electrodes into Level 4 centers, an opportunity for us to expand the footprint of the technology as well. And so we’ve been really pleased with the progress that we’ve made with DIXI, but I also see opportunities in a number of different kind of vectors there to leverage the distribution relationship in our organization to broaden the adoption and utilization of DIXI as well as with RNS.

Thanks, Joel.

Thank you.

There are no further questions at this time. Please continue.

Thank you. And thank you, everyone, for joining the call tonight. Thank you for the time and for your interest in and support of NeuroPace. We look forward to and are excited about 2024. And continuing NeuroPace’s mission of transforming the lives of patients living with debilitating seizures. Thanks to all.

Ladies and gentlemen, this concludes today’s conference call. Thank you for joining. You may now disconnect.