Good afternoon and welcome to NeuroPace's Second Quarter 2023 Earnings Conference Call. As a reminder, this conference is being recorded. I would now like to turn the call over to Irina Ridley, Chief Legal Officer and Head of Investor Relations for a few introductory comments.

Good afternoon. Thank you for joining us for NeuroPace's second quarter 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 second quarter ended June 30, 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, the impact of COVID-19 on our business and prospects for recovery, 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 statements. Accordingly, you should not place undue reliance on these statements. For a 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 annual report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 2, 2023 our quarterly report on Form 10-Q for the period ended March 31, 2023 filed with the SEC on May 4, 2023 and our quarterly report on Form 10-Q for the quarter ended June 30, 2023 to be filed with the SEC, as well as any 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 August 8, 2023. 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?

Thank you Irina, and good afternoon everyone. It is my pleasure to be here with you today on my first quarterly earnings call with NeuroPace. I'm excited about and committed to advancing our company's mission to transform the lives of people living with epilepsy with RNS therapy. I'm pleased with what I've seen in the solid underlying fundamentals of the business, excited by the opportunities that lie ahead, and committed to leading NeuroPace to deliver on our commitments of consistent revenue growth, operating discipline and effective cash management. I am also very thankful for the opportunity to lead the talented and experienced team at NeuroPace. On today's call, I will provide highlights from the second quarter of 2023, and review our key business priorities for the remainder of the year. I will then turn the call over to our CFO, Rebecca Kuhn to present the details of financial performance for the quarter, before opening the call to Q&A. I am pleased to report total revenue was $16.5 million, representing growth of 62% compared to the prior year period and 14% compared to the first quarter of 2023. The strong performance was primarily driven by increased utilization of the RNS system within comprehensive epilepsy centers, or CECs; revenue contribution from our partnership with DIXI Medical to distribute their SEEG electrodes in the United States; and implants of our RNS system in the NAUTILUS study. As we previously communicated, replacement implant revenue continues to decline, as we complete our transition to our second-generation device with a longer-lasting battery. It now represents approximately 5% of total revenue and is expected to decline further in the second half of 2023. Given the strong underlying fundamentals of the business, we are raising full year 2023 revenue guidance to range between $59 million and $61 million,…

Thank you, Joel. And once again thank you Mike. NeuroPace's revenue for the second quarter of 2023 was $16.5 million, representing growth of 62% compared to $10.2 million for the second quarter of 2022 and 14% sequentially compared to $14.5 million in the first quarter of 2023. Our strong performance was primarily driven by increased utilization of our RNS system by physicians in treating new patients. We also had meaningful revenue from DIXI Medical products, which was higher than we anticipated previously. Replacement implant revenue continued to decline again this quarter as anticipated and was approximately 5% of total revenue. Gross margin for the second quarter of 2023 was 72.5% compared to 73.2% in the second quarter of 2022, and 71.7% in the first quarter of 2023. The decline in gross margin relative to the prior year period was primarily due to a change in product mix with the inclusion of DIXI medical products, which have a lower gross margin than our core RNS products. Over time, we expect our gross margin will generally increase as RNS volumes increase and fixed overhead is allocated over more units. Total operating expenses in the second quarter of 2023 were $19.8 million, compared with $18.4 million in the same period of the prior year. In the second quarter of 2023, operating expenses as a percentage of revenue were lower for both R&D and SG&A. This was the result of our continued focus on appropriate resource allocation and cash management. And as Joel said, we plan to continue focusing on effectively managing our operating expenses going forward. R&D expense in the second quarter of 2023 was $5.3 million, compared with $5.7 million in the same period of 2022. The decrease in R&D expense included reductions in outside services for product development and clinical studies,…

Thank you, Rebecca. Overall, the first half of the year results have been strong with CECs continuing to expand initial implant volume, our distribution partnership with DIXI Medical contributing nicely to those efforts and our clinical development program with NAUTILUS in the generalized epilepsy population is advancing as planned with tremendous opportunity and potential on the horizon. Building on the momentum with our core CEC customer group, I'm also very excited about the prospect of expanding drug-resistant epilepsy patient access to RNS therapy through an expanded group of epileptologists and neurosurgeons in the community setting and look forward to keeping you updated on those efforts. Cash reserves remain strong and spending well managed. We believe that we have sufficient capital to take us to mid-2025. All of these factors position NeuroPace well for the remainder of 2023 into 2024 and beyond. 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?

Thank you. [Operator Instructions] Your first question comes from Frank Takkinen with Lake Street Capital Markets. Please go ahead.

Great. Thanks for taking my questions and great quarter. Congratulations Joel on the appointment and I'll also extend my gratitude to Mike. I was hoping we could start with one around the guide. Obviously, a great quarter you guys had here even after backing out the 5% contribution from replacement. It feels like the back half you guys have done a nice job of staying conservative and prudent with the forward outlook. But maybe talk a little bit about what needs to occur to achieve the guidance that you guys have laid out for 2023 and what could be sources of upside as you start to think about second half 2023?

Thank you, Frank, and thanks on behalf of the team. Thanks for the question. When we talk about guidance for the rest of the year, I think it bears mentioning that we're raising guidance by the amount of the beat in Q2 plus nearly that much again for the rest of the full year. And that puts us in a position of having raised by $7 million, which is again nearly that beat plus the $3 million. And that's in addition to the guide that we raised by $2 million in the first quarter, putting us up now $9 million in guidance for – from how we were thinking about the business at the start of the year. So as we mentioned, we do think it bears consideration, as well as you mentioned that we do expect replacement implants and revenue to be down somewhat in the second half of the year. But our guidance here for the rest of the year really takes into account what we've seen in the business in terms of the growth in initial implants in RNS, the good growth contribution that we've seen from DIXI and the dynamics that I mentioned around the replacement implants. So it's really those factors that are driving the second half of the year guidance, and that's what we're focused on.

Okay. That's helpful. Maybe shifting over to one on initial implants. I realize you guys are intentionally not breaking that out. But can you put some goalpost around just where that number came in trying to understand just the source of outperformance? I think it's looking at my model and making some estimates that you can say a plus 30% initial implant number is probably rather conservative for the quarter but any further clarity you can provide to break out the performance between initial implants and DIXI?

Yes. I think as we've talked about we're not breaking out revenue by different product lines. But what I would say is that we had strength in revenue performance across the different product lines. The initial implant contribution, primarily was driven by utilization within existing centers. And so it was primarily existing centers driving that increase in initial RNS implants. But good contributions really across the business with some accelerated strength in replacement implants as we've mentioned.

Okay. Perfect. And then maybe just for my last one, I was hoping to have a follow-up on qualification requirement, downgrade if we can call it that to epileptologist not at a Level four CEC. Maybe just take us a little bit deeper into how – just how impactful that can be? And if you've already started to maybe see some impact from that change?

Great. Thanks for that question as well, Frank. We're excited about the opportunity here for site expansion, really for the role that we see it playing in advancing NeuroPace's mission. Our focus is transforming the lives of patients and people who are suffering from epilepsy and we see the opportunity here to expand sites as an opportunity to help close the treatment gap for patients who are indicated in our drug-resistant epilepsy patients. You would know but there are 1.2 million people in the United States living with drug-resistant epilepsy. About 50,000 of those are admitted to one of approximately 200 Level four centers. And we believe that the opportunity here is to expand the number of physicians and associated centers to a significant fraction of epileptologists and an additional 1,800 epileptologists from the 1,200 that are associated with Level 4 centers and then really expanding to the entire population of stereotactically trained functional neurosurgeons. So we see that opening up the community setting, where we think an enlarged group of both clinicians as well as then as RNS therapy gets more broadly visible in the epilepsy community patients as well, and the ability to build stronger referral pathways even back into the CECs as well. So when you think about that in the past where we've really been limited and focused on those Level 4 CECs, this opens up our ability to take out two eligible clinicians and centers, RNS therapy to patients who may be – who would not have had access to it before. And we think that's really exciting. We'll talk more about – we're right at the start of this and so we'll talk more about modeling the opportunity and how we see all that in future calls. But again, with the expansion in clinician requirements and center requirements that we see here, we think this lines up very nicely with – our overall commercial strategy is to increase therapy access in CECs for patients that are in comprehensive epilepsy centers, expand indications for patients for RNS therapy like through the work that we're doing with the NAUTILUS trial and then thirdly expand clinician and site access. And we think this regulatory approval and the changing qualification criteria lines up, very nicely with that third prong of that overall, market development strategy.

Great. I’ll stop there. Thanks for taking the questions. And congrats on a really strong start to the first half. A – Joel Becker: Thank you, Frank.

Your next question comes from Robbie Marcus with JPMorgan. Please go ahead. Q – Unidentified Analyst: Hi, this is Allen [ph] on for Robbie. Just to check, can you hear me okay? A – Joel Becker: We can Allen, thank you. Q – Unidentified Analyst: Got it. Yes, this is Allen just moving back to the issues want to make sure, those factoring in but congrats on the good quarter. I think when we look back to some of the conservatism, you had after the strong first quarter you talked about how the EMU, the procedure environment hadn't exactly returned to pre-pandemic levels due to staffing, but clearly, it looks like trends have continued to improve in the second quarter. So, when we look out to third quarter, fourth quarter should we think about it as basically being a fairly normal operating environment, or was there maybe some one-time catch up in the quarter, that really drove the strength? A – Joel Becker: So, I think – Alan, thank you for the question and for the congratulations on behalf of the team. So, when we look at volumes again, we really saw strength across the different pieces of the business and really that strength coming from initial implants as well as from the contributions from DIXI. We do see that patient volumes, we believe going through the epilepsy monitoring units have strengthened. And they've strengthened our pipeline. And while we don't know yet, whether the volume in those comprehensive epilepsy centers has consistently fully returned, we believe that we have seen strengthening. Does that answer your question? Q – Unidentified Analyst: Yes, that's helpful. And then, I guess one on I guess the expanded criteria, if you will. When we think about what's needed to really target the opportunity, I…

[Operator Instructions] Your next question comes from Paige Chamberlain with Wolfe Research. Please go ahead.

Hi, guys. Thank you for taking my questions. I have one on DIXI. We understand there's several strategic reasons behind that partnership one being more visibility into the patient funnel. So I guess, I'm just curious now that you're about nine months into this agreement what have you been learning? And is this partnership helping you identify more patients on the front end and manage the patient funnel any better?

Hi, Paige, thank you for your question. It's a great question. Let me say, we are a few months into this but it is still relatively early as we think about the sales integration process and how the collaboration is integrating with both our current customer base as well as potential new customers. I would say that, we are pleased with how things have started. We have seen positive contributions to both revenue as well as our ability to get visibility further up the pipeline. And we're continuing to work closely with both DIXI as well as with our field team in further defining and executing on those both current opportunities as well as customer expansion opportunities. So we're pleased with what we've seen so far. We're pleased with the contribution that we've seen to the current business, as well as how it's helping us look into the pipeline deeper, but it's also still relatively early in our overall integration efforts.

Got it. Thank you. And then one more kind of jumping off that too. You guys mentioned, there were some changes to the sales force in the quarter. So I guess just kind of on an overall level, how are you feeling about the field team? Maybe if you could share any motivations behind some of those changes and what the changes will look like in practice? And then just for completeness how is DIXI the partnership at all changing the sales strategy? Obviously, it's helpful to have another lever to pull but what is that looking like in the field?

Paige, this is Rebecca. I'll comment on changes in the sales team. There may have been a bit of confusion about that. We had a change in our sales leadership this quarter, with the new VP of Sales, which we announced about two months ago. Other than that, we have not had changes in the sales team. As you may recall, we accelerated growth in our sales teams earlier in 2022. But other than the change in sales leadership there were not changes this quarter. Our field commercial organization remains about the same size that it has been for the full year.

All right. Thank you.

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

Thank you. And I'd like to say thank you to all who are on the call today, and for your interest in NeuroPace. We're pleased with the first two quarters of 2023. We're focused on execution throughout the rest of the year, and we're excited about both the recent progress on and the future opportunities with our site expansion and clinical study work to expand patient indications in the drug refractory generalized epilepsy population with the NAUTILUS study. All of that, with a focus on furthering NeuroPace mission to transform the lives of people suffering from epilepsy. Thank you, operator. With that, we'll conclude today's call.

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.