5/12/2026

speaker
Abby
Conference Operator

Ladies and gentlemen, thank you for standing by. My name is Abby and I will be your conference operator today. At this time, I would like to welcome everyone to the NeuroPace first quarter earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you, and I would now like to turn the conference over to Scott Schaefer, Head of Investor Relations. You may begin.

speaker
Scott Schaefer
Head of Investor Relations

Thank you, Operator, and welcome to NeuroPace's first 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 IGE PMA supplement, 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. The 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. 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. Joel?

speaker
Joel Becker
Chief Executive Officer

Thanks Scott and good afternoon everyone. I will start with an overview of our first quarter results and how the team is executing against our strategy, followed by updates on key clinical and product development initiatives. After that, Patrick will walk through the financials and our revised outlook before we open the line for Q&A. The first quarter reflects continued execution against the priorities we outlined earlier this year. We delivered total revenue of 22.1 million dollars in the quarter and excluding dixie medical we delivered 22 million in revenue representing eight percent year-over-year growth with rns system revenue of 21.7 million dollars importantly the underlying fundamentals of the business remain solid as we reached new all-time highs in active prescribers accounts and patient pipeline during the quarter These are leading indicators we track closely and give us confidence in the durability of demand for the RNS system. The majority of growth continues to be driven by level four comprehensive epilepsy centers, which remain the core of our commercial focus. In addition, we continue to see encouraging trends in the front end of the patient funnel with the rate of new patients being added to the pipeline continuing to accelerate. While the majority of procedures remain concentrated within level four comprehensive epilepsy centers, community relationships are increasingly serving as durable referral channels. We believe this is important not only for continued penetration of the adult focal population, but also for establishing referral pathways that will be relevant as we potentially expand into IGE. Regarding guidance, we are raising our full year 2026 revenue guidance to a range of $99 million to $101 million, up from $98 million to $100 million previously. This reflects 21 to 23% underlying RNS growth from our existing adult focal indication and does not include any contribution from idiopathic generalized epilepsy indication expansion. From a market development perspective, we continue to invest in the commercial organization. This includes targeted sales representative additions and key geographies, updates to our sales incentive structure to better align with growth objectives, and additional resources dedicated to helping patients navigate the funnel from identification to implant. These investments are designed to reduce friction in the patient pathway and increase procedural consistency over time. We expect them to become increasingly productive throughout 2026. Let me now turn to clinical developments. During the quarter, we completed our FDA mid-cycle review meeting for the Nautilus PMA supplement, sometimes referred to as a day 100 meeting, which we viewed as a productive step in the overall regulatory pathway. As a reminder, the PMA supplement was submitted on December 15th, and the 180-day review clock began upon acceptance of that submission. As part of the PMA supplement review process, the FDA has the ability to pause the 180-day review clock to request additional information or clarification. During the quarter, the agency exercised that option to seek certain follow-up information in conjunction with our mid-cycle review meeting. We view this as a standard and constructive part of the review process, and we were pleased with how quickly the agency provided their questions which allowed us to respond promptly and thoroughly with robust information during and following the meeting. At this time, we have responded to the agency's requests and the dialogue continues to be productive. Importantly, based on our interactions today, we continue to believe a mid-year determination remains on track. The breakthrough device designation continues to be meaningful in this process, allowing for more consistent interaction and timely feedback as the review progresses. The ongoing dialogue we are experiencing, including the ability to address clarifying questions in real time, is consistent with the intent of that program and reflects the collaborative nature of the review. As a reminder, our 2026 revenue guidance does not include any contribution from IGE indication expansion. If approved on our current timeline, contribution would begin in the second half of the year. and we would provide updated guidance at the appropriate time once we have greater visibility into timing and reimbursement dynamics. From a data perspective, we remain confident in the totality of the Nautilus clinical results. As a reminder, 18-month data presented at the American Academy of Neurology annual meeting in April demonstrated a 77% median reduction in generalized tonic-clonic seizures with sustained reductions over time along with favorable safety outcomes in a highly refractory population. Additionally, reductions in absence and myoclonic seizures exceeded those observed for generalized tonic-clonic seizures. Injury events also declined by approximately 30% following treatment. And the use of benzodiazepines as rescue medication for generalized tonic-clonic seizures was 44% lower compared with baseline. with strong physician and patient reported clinical improvement. These clinical findings are meaningful because they speak to the real-world impact beyond seizure counts, including fewer seizure-related injuries and reduced reliance on rescue interventions, both of which can translate into improved safety and quality of life. In parallel, we continue to build our leadership position in clinical evidence. Our three-year post-approval study results in drug-resistant focal epilepsy were published in the journal Neurology in late April, demonstrating an 82% median seizure reduction in study subjects. This publication reflects data from a rigorously conducted FDA-monitored prospective study, not retrospective registry data, and reinforces the durability and strength of long-term outcomes with the RNS system. Now turning to product development. The roadmap we outlined on our fourth quarter call remains on track. Our priorities continue to be our suite of NeuroPACE AI tools, development of a multimodal foundational model, remote care, and progress toward automated detection and next-generation system development. Our ECOG assistant, previously known as SeizureID, represents the first step in our NeuroPACE AI suite. This is an AI-enabled tool designed to assist clinicians in analyzing patients' IEEG records of interest and efficiently identify likely electrographic seizure activity upon which to focus their clinical decision-making. This is a highly desired capability addressing a real workflow challenge and supports clinicians in their ability to individualize care. We are encouraged by the early performance we are seeing in internal testing and validation work of this tool. We believe this product can serve two important purposes. First, it lowers the barrier for new physicians adopting RNS by simplifying data review. Second, it deepens engagement among existing high utilizing centers by improving efficiency and allowing clinicians to manage more RNS patients within their practice. Importantly, the submission is paired with moving our clinician platform to the cloud, which improves scalability and supports faster deployment of software and data products over time. We expect ECOG assistant approval in the second quarter of 2026. We are also advancing the development of a multimodal foundational model leveraging our proprietary intracranial EEG dataset and the clinical experience derived from more than 8,000 patient implants across 35,000 patient years. The EEG component of this model is currently in training. And although we're approximately one-third of the way through the training process, early internal validation work has been encouraging. Even at this early stage, the model is outperforming prior internal algorithmic approaches we had been developing. We believe this reflects the power of scale in our dataset and reinforces the strategic value of the more than 26 million intracranial EEG recordings we have accumulated. Importantly, we are uniquely positioned here. No other neuromodulation platform has a comparable depth of longitudinal intracranial EEG data linked to therapy and outcomes. And leadership in this area matters as the field moves toward a data-guided, personalized neuromodulation approach. As the model continues to train and refine, we see meaningful opportunity to enhance treatment optimization, improve outcomes, and further differentiate the RNS platform. With that, I'll turn it over to Patrick for review of the financials and outlook.

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