Neuropace, Inc.

Ladies and gentlemen, thank you for standing by. My name is Colby, and I'll be your conference operator today. At this time, I would like to welcome you to the NeuroPace Q3 earnings call. All lines have been placed on mute to prevent any background noise, and after the speaker's remarks, there will be a question and answer session. If you'd like to ask a question at that time, please press star, then the number one on your telephone keypad. If you'd like to withdraw your question at any time, please press star one again. Thank you. I would now like to turn the call over to Scott Schaefer, head of investor of NeuroSpace. Please go ahead.

Thank you, operator, and welcome to NeuroPace's third quarter 2025 earnings conference call. Our agenda begins with Joel Becker, NeuroPace's chief executive officer, who will summarize our recent highlights and ongoing strategic initiatives, followed by a financial review and outlook from Patrick Williams, our chief financial officer. Following our prepared remarks, we will open the call up for your questions. At that time, we ask the analysts to limit themselves to one question and one follow-up question each so we can provide an opportunity for everyone participating today. Let's quickly review our safe harbor statement. Some of the statements we will make on today's call may constitute forward-looking statements. These statements reflect management's intentions, beliefs, and expectations about future events, strategies, products, regulatory and operating plans, and performance. All forward-looking statements included on this call are made as of the date hereof based on information currently available to NeuroPACE, are subject to various risks and uncertainties, and actual results could differ materially from those anticipated in the forward-looking statements. The factors that could cause actual results to differ materially from those expressed or implied by any of these forward-looking statements are detailed in NeuroPACE's annual report on Form 10-K most recent quarterly report on Form 10Q and other filings with the Securities and Exchange Commission. Except as required by law, we assume no obligation to update any such forward-looking statements after the date of this call or to conform these forward-looking statements to actual results. And with that, I will now turn the call over to NeuroPACE's Chief Executive Officer, Joel Becker. Joel?

Thanks, Scott, and good afternoon, everyone. I will start with an overview of our third quarter results and how the team is executing against our strategy. I will then provide updates on our key clinical and product development initiatives. After that, Patrick will walk through the financials and updated guidance before opening the line for Q&A. The third quarter was one of record results for NeuroPACE and demonstration of the effectiveness of our strategy and its execution. Total revenue in the quarter was $27.4 million, delivering 30% year-over-year growth compared to $21.1 million in the prior year quarter. This record revenue was primarily driven by RNS initial implants, resulting in RNS revenue of $22.6 million and representing growth of 31% year-over-year. R&S growth in the quarter was broad-based across geographies, customers, and programs. All sales regions exceeded planned sales for the quarter with the number of prescribers, accounts, and utilization nationally reaching all-time highs. These results demonstrate the compounding effects of the recognition of the differentiated capabilities of the R&S system, enhanced commercial leadership and execution, and improved referral management driving higher procedural volumes. The majority of our growth came from level four centers with increased adoption and utilization. Project CARE also contributed meaningfully and again improved sequentially and year on year. We also saw increased contribution from our direct-to-consumer efforts as well. We remain confident in our long-term growth trajectory of growing a minimum of 20% in our core R&S business with our current adult focal epilepsy indication. Importantly, gross margin and operating leverage were also strong and continued to be highlights as we scaled growth in a disciplined manner. Additionally, during the quarter, NeuroPace generated positive adjusted EBITDA, a significant milestone for the company and the first time in our history. This important accomplishment reflects the scalability of our model and the progress we are making with disciplined expense management, consistent mix improvement, and increasing efficiency in both commercial and manufacturing operations. We are proud of this achievement. And while this metric may vary quarter to quarter, we remain committed to driving towards sustainable profitability and cash flow breakeven. Given the performance in the quarter, we are raising both our full year revenue and gross margin guidance ranges. For revenue, we now expect a range of $97 million to $98 million, or 21% to 23% year-over-year growth, an increase from previous guidance of $94 to $98 million. Let me now turn to our key clinical and product development initiatives, starting with Nautilus and our recent meeting with the FDA. As expected, we completed our pre-submission meeting with the FDA in September, which we believe was a productive and engaged discussion of the study. We reviewed the totality of the evidence, safety, the primary effectiveness endpoint, and the pre-specified secondary endpoints, as well as additional analysis. We continue to believe the safety and effectiveness profile of the Nautilus data supports a favorable benefit-risk assessment for this highly underserved population, and our PMA supplement will incorporate the discussion points from our meeting. We appreciate the opportunity to meet with you, and the dialogue was consistent with our expectations. Development of our PMA supplement application is underway, and our timeline and plans remain on track to submit the PMA supplement for Nautilus before year end. Moving on to our pediatric indication. We continue to work closely with the FDA and our collaboration partner, NEST, as we finalize the real-world evidence and protocol for our pediatric indication. We are working to ensure that the dataset and protocol are both as strong as possible. As we continue this process, it has taken more time to align on that protocol and dataset than we had initially built into our timeline. We remain confident about the approach of leveraging real-world evidence to gain this much-needed indication expansion in a pediatric patient population. As we finalize, the real-world evidence and protocol timing for submission will extend beyond 2025. We are not providing a revised submission date today, but will provide updates as milestones are met. We are appreciative of the quality of the interactions with FDA and NAST and the iGOID collaboration as we pursue this unique opportunity. We look forward to advancing the syndication expansion pathway and remain committed to bringing RNS therapy to the pediatric population. I also want to highlight the growing recognition that RNS and our unique closed-loop stimulation is receiving across the field. The September issue of the Journal of Clinical Neurophysiology was entirely dedicated to the use of data and feedback for personalizing intracranial neuromodulation, and several articles featured RNS at the center of that conversation. This journal is one of the most widely respected peer-reviewed publications in the field of epilepsy and brain modulation. It is the official journal of the American Clinical Neurophysiology Society and a key forum where leading researchers and clinicians publish data that shape standards of care. The editors described a critical shift underway in epilepsy therapy away from one-size-fits-all stimulation and toward data-guided patient-specific neuromodulation. Driving that shift is the convergence of long-term intracranial EEG, advanced neuroimaging, and artificial intelligence, and the critical importance of developing individualized treatments in clinical settings. For years, the RNS system has generated data and outcomes that define what personalized closed-loop therapy could be. Now, as AI and computational tools mature, the importance of the RNS system's unique ability to monitor and record data and then tailor individual therapies for specific patients through its differentiated closed-loop capabilities is coming further into focus. We believe the broader scientific community is recognizing that the RNS system platform is best positioned to capitalize on this new era of innovation that is beginning to shape the future of epilepsy neuromodulation and brain-computer interface development. We are now seeing a number of factors we've been working on deliberately for years start to come together at the same time. The clinical maturity of closed-loop neuromodulation, the scale and quality of our long-term intracranial EEG dataset, and the computational tools to act on that data in real time. And critically, we now have the tenure domain knowledge and execution muscle on the team to capture this opportunity. This convergence is creating an environment for the potential of accelerated adoption of closed loop personalized neuromodulation. We believe the RNS system is uniquely positioned to capitalize on this new era of data guided epilepsy care and longer term on the direction the field is heading in neuromodulation and brain-computer interface, or BCI. Now to an update on product development. Our RNS development pipeline is focused on extending the platform advantages just mentioned with greater on-device analytics capabilities, streamlined programming workflows, and enhanced connectivity to further improve both the quality and time to improved outcomes as well as enhance efficiency and ease of use to support wider adoption. We recently submitted to the FDA our seizure ID AI software tool, the first of a suite of planned neural pace AI applications, which utilizes our proprietary IEG data and AI development efforts and is designed to improve clinical outcomes. With that, I'll turn it over to our Chief Financial Officer, Patrick Williams, to review the financials and our outlook. Patrick?