Neuropace, Inc. Common Stock 2026 Q2 Earnings Call

Scott, please go ahead. Thank you, operator, and welcome to NeuroPace's second 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. 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, our commercial strategy, clinical and product development initiatives, regulatory matters including our PMA supplement for expanded indications into idiopathic generalized epilepsy, or IGE, 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-Q. We undertake no obligation to update or revise any forward-looking statements except as required by law. As of June 30, 2026, the company is now reporting its former distribution arrangement with DIXI Medical as discontinued operations. In accordance with US GAAP, and unless otherwise noted, the financial results discussed in this call reflect continuing operations. Prior period amounts have been recast to exclude the results from the distribution arrangement with DIXI Medical for the 2026 reporting periods and applicable comparable periods presented.

See the accompanying financial statements for the GAAP presentation of continuing and discontinuing operations. In addition, we will discuss certain non-GAAP financial measures on today's call, including adjusted EBITDA. Reconciliations of non-GAAP measures to the most directly comparable GAAP measures are included in our 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.

Thanks, Scott, and good afternoon, everyone. I will begin with an overview of our second quarter results and the continued execution of our commercial strategy. I will then provide updates on our ongoing IGE regulatory process and product development initiatives. After that, Patrick Williams will walk through our financial results and updated outlook before we open the line for questions. To start, our second quarter performance reflects continued momentum in the core RNS business and disciplined execution across the organization. Total revenue was $22.8 million, including RNS System revenue of $22.5 million, representing 21% RNS System growth compared with the prior year period. Throughout the first half of 2026, RNS revenue grew in excess of 20%, consistent with the underlying long-term growth framework we have established for our current indication. During the quarter, we again reached new all-time highs in active prescribers, active accounts, and our patient pipeline.

We view these as important indicators of the breadth and durability of adoption across the business. The majority of our growth continues to be generated within level 4 comprehensive epilepsy centers, driven by increased adoption and utilization among existing and new prescribers. At the same time, our community access initiatives continue to contribute by expanding referral pathways and helping more patients move toward appropriate evaluation and treatment. Patrick Williams will provide more details on the quarter and our full financial guidance, including our increased revenue guidance to $99.5 million-$101.5 million, with underlying RNS revenue growth still on track at 21%-23% year-over-year. Additionally, we continued to demonstrate strong gross margin performance and disciplined allocation of resources and operating expense management. Let me now turn to clinical development and our IGE PMA supplement.

As we communicated on July 28th, the FDA informed us that the PMA supplement was not approvable in its current form due to requests for additional information regarding the clinical evidence supporting the submission. Given how recently we held that call, I will not repeat every detail today. For a more detailed discussion, please refer to a replay of our IGE PMA supplement call, which is available on our website. However, I did want to highlight a few key points. For clarity, this was not the outcome we expected, and we were disappointed not to receive an initial approval. At the same time, there are several important elements of the agency's communication and our subsequent interactions that inform our view that there is a path towards approval.

First and foremost, in our communications, the FDA made clear that the agency's response was not a disapproval, and the process has remained highly interactive. The agency strongly recommended that we use the submission issue request, or SIR process, which we are now pursuing, to align on the content of an amendment response. The agency's additional questions are not related to safety. Rather, the FDA is seeking additional information and context around the clinical benefit observed across certain patient subgroups, including by baseline GTC seizure frequency, as well as the clinical meaningfulness of reducing GTC seizures. Our planned amendment will present the totality of the evidence, including additional subgroup analysis, patient and physician-reported outcomes, relevant published and real-world evidence, and the 24-month data, which showed a 100% median reduction in GTC seizures among evaluable patients.

On timing, we continue to expect the amendment may be reviewed without resetting the full 180-day clock, though the agency has discretion. Preparation of our data analysis needed before requesting an SIR meeting with the FDA remains on track, and we expect to schedule the SIR meeting over the next few weeks. This meeting will allow us to discuss our planned approach with the agency before submitting our amendment response. Consistent with our previous commentary, we continue to see a path forward towards approval and will provide an update as we gain greater clarity on the regulatory timeline and future interactions. Moving out of product development, during the quarter, we launched ECoG Assistant, the first AI algorithm-based tool in our planned suite of NeuroPace AI products.

ECoG Assistant is the world's first AI algorithm-based tool in the neuromodulation space, designed to help clinicians identify ECoGs of interest, review trends over time, and assess circadian patterns. It is made possible by the RNS System's unique ability to continuously monitor, record, and analyze each patient's intracranial EEG data over time, creating a capability unique to the RNS platform. By applying AI developed from our proprietary physician-labeled dataset, ECoG Assistant is intended to make review more efficient while providing clearer, more accessible insights to support individualized treatment decisions. The early feedback from the field has been encouraging, both in terms of workflow efficiency and the clinical usefulness of the information. Physicians are already finding new ways to use these insights to inform treatment decisions, including medication timing, therapy adjustments, and longer-term patient management.

At one epilepsy center, a physician used the circadian pattern data alongside the patient's clinical report to provide additional context for treatment planning. Prior to reviewing the information, the physician had been considering an increase in stimulation settings. The ECoG Assistant insights helped inform the physician's independent clinical decision-making, and the physician ultimately chose to adjust the timing of the patient's medication instead. We have also seen clinicians use event timing information to identify periods when medication coverage may be inadequate and adjust patients to longer-acting medication formulations. More broadly, clinicians are reporting that the updated tool simplifies review and provides meaningful time savings across a full RNS clinic. The launch is also giving our commercial team a new way to expand the scope of the discussions within existing accounts.

By demonstrating how ECoG Assistant can simplify data review and support clinical decision-making, the team is engaging a broader group of physicians and reinforcing the differentiated value of the long-term data generated by the RNS System. These early examples illustrate why ECoG Assistant is strategically important. Beyond delivering meaningful efficiency in routine patient review, ECoG Assistant demonstrates how our unique device capabilities and associated proprietary data assets can be translated into practical capabilities that support more informed treatment decisions and improve the experience of managing RNS patients with capabilities that uniquely differentiate the RNS System. The remainder of our product development roadmap also continues to progress, including additional AI-enabled tools, development of our multimodal foundational model, remote care capabilities, automated detection, and our next-generation system.

During the quarter, related to our multimodal foundational model, we completed a key phase of model training and continued testing its ability to interpret increasingly complex patterns in intracranial EEG data. Encouragingly, the model is learning clinically relevant patterns in brain activity, suggesting the potential to uncover individualized patterns and relationships that are difficult to detect using traditional approaches. We believe this is an important step toward generating new insights and, as the model continues to train and refine, see meaningful opportunity to further personalize therapy, optimize treatment, and improve patient outcomes over time. Importantly, all of this is made possible by NeuroPace's proprietary data asset, which now includes more than 27 million intracranial EEG recordings generated from recordings within the RNS System.