Neuropace Inc (NPCE) 2025 Q2 法說會逐字稿

Ladies and gentlemen, greetings, and welcome to the NeuroPace, Inc second-quarter 2025 earnings call. (Operator Instructions) As a reminder, this conference is being recorded.

女士們、先生們，大家好，歡迎參加 NeuroPace, Inc 2025 年第二季財報電話會議。（操作員指示）提醒一下，本次會議正在錄音。

It is now my pleasure to introduce your host, Scott Schaper, Head of Investor Relations at NeuroPace, Inc. Please go ahead.

現在我很高興介紹您的主持人，NeuroPace, Inc. 投資者關係主管 Scott Schaper。請繼續。

Good afternoon. Thank you for joining us for NeuroPace's second-quarter 2025 financial and operating results conference call. On today's call, we will hear from Joel Becker, Chief Executive Officer; and Patrick Williams, Chief Financial Officer. Earlier today, NeuroPace released financial results for the second quarter ended June 30, 2025. A copy of the press release is available on the company's website at neuropace.com.

午安.感謝您參加 NeuroPace 2025 年第二季財務與營運績效電話會議。在今天的電話會議上，我們將聽取執行長喬爾貝克爾 (Joel Becker) 和財務長 Patrick Williams 的演講。今天早些時候，NeuroPace 發布了截至 2025 年 6 月 30 日的第二季財務表現。新聞稿副本可至本公司網站 neuropace.com 查閱。

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.

在我們開始之前，我想提醒您，在整個電話會議過程中，我們將根據 1995 年《私人證券訴訟改革法案》的安全港條款做出包括聯邦證券法含義內的前瞻性陳述。本次電話會議中所做的任何與未來事件、結果或表現的預期或預測有關的陳述均為前瞻性陳述。

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 forecast 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.

所有前瞻性陳述，包括圍繞 NeuroPace 的預測、商業機會、商業擴張、市場條件、臨床試驗以及與我們的營運趨勢和未來財務表現、費用管理、市場機會估計以及市場和收入成長預測相關的陳述，均基於當前估計和各種假設。這些聲明涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性聲明所暗示的結果或事件有重大差異。因此，您不應過度依賴這些聲明。

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 quarterly report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 12, 2025, and any other reports that we may file with the SEC in the future.

有關與我們的業務相關的風險和不確定性的更詳細描述，請參閱我們向美國證券交易委員會提交的公開文件中的風險因素部分，包括我們於 2025 年 8 月 12 日向美國證券交易委員會提交的截至 2025 年 6 月 30 日的季度 10-Q 表將來季度報告，以及我們提交的任何其他證券交易委員會報告。

This conference call contains time-sensitive information, which we believe is accurate only as of this live broadcast on August 12, 2025. 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.

本次電話會議包含時間敏感訊息，我們認為這些資訊僅在 2025 年 8 月 12 日的現場直播時準確。NeuroPace 不承擔任何更新或修改任何財務預測或前瞻性聲明的意圖或義務，除非法律要求，無論是由於新資訊、未來事件或其他原因。

And with that, I will now turn the call over to NeuroPace's Chief Executive Officer, Joel Becker. Joel?

現在，我將把電話轉給 NeuroPace 的執行長 Joel Becker。喬爾？

Thank you, Scott, and good afternoon, everyone. On today's call, I will provide a high-level overview of our second quarter results and share updates across our key strategic pillars, including market, clinical and product development. I will then turn the call over to our CFO, Patrick Williams, to walk you through the details of our financial performance and our updated outlook before opening the line for Q&A.

謝謝你，斯科特，大家下午好。在今天的電話會議上，我將概述我們第二季的業績，並分享我們主要策略支柱的最新情況，包括市場、臨床和產品開發。然後，我將把電話轉給我們的首席財務官帕特里克·威廉姆斯 (Patrick Williams)，向您介紹我們的財務業績和最新展望的詳細信息，然後再開始問答。

Second quarter was another strong quarter that reinforces the momentum we are seeing in the business and the consistency of the strategy we have been executing, deepening adoption and utilization within our current indication and customer base, while expanding access to RNS therapy through new sites of service and clinical indication expansion.

第二季度是另一個強勁的季度，它鞏固了我們在業務中看到的勢頭和我們一直在執行的策略的一致性，深化了我們當前適應症和客戶群中的採用和利用，同時透過新的服務地點和臨床適應症擴展擴大了 RNS 治療的覆蓋範圍。

These efforts are working, and the trends continue to move up and to the right. We delivered another record revenue quarter with strong revenue of $23.5 million, representing 22% growth compared to $19.3 million in the prior year period. Growth was driven by continued strength in sales of our core RNS System, supported by increased commercial activity and broader prescriber engagement.

這些努力正在發揮作用，趨勢繼續向上和向右發展。我們又創下了季度營收記錄，營收強勁，達到 2,350 萬美元，與去年同期的 1,930 萬美元相比成長了 22%。成長的動力來自於我們核心 RNS 系統銷售的持續強勁成長，以及商業活動的增加和處方者參與度的擴大。

Importantly, this growth was achieved with a total gross margin above 77% and RNS gross margin above 80%, along with continued operating discipline. Operating expenses, excluding certain onetime non-recurring items related to executive transition, grew 13% in the quarter and significantly below our sales growth rate.

重要的是，這一增長是在總毛利率超過 77% 且 RNS 毛利率超過 80% 以及持續的經營紀律下實現的。不包括與高階主管過渡相關的某些一次性非經常性項目，本季營運費用成長了 13%，遠低於我們的銷售成長率。

Our base business continues to perform well with another quarter of record high prescribers and active accounts as we further expand access in both Level 4 centers and in the community. RNS System revenue grew 16% in the quarter and 21% in the first half of 2025. We are pleased with the demonstrated disciplined growth and remain confident in the durability and trajectory of our growth profile.

隨著我們進一步擴大 4 級中心和社區的醫療服務覆蓋範圍，我們的基礎業務繼續表現良好，處方量和活躍帳戶數量再創季度新高。RNS 系統營收本季成長 16%，2025 年上半年成長 21%。我們對所展現的有序成長感到滿意，並對我們的成長前景的持久性和軌跡充滿信心。

Project CARE contributed to growth again this quarter. As a reminder, CARE is focused on expanding access to RNS by enabling referrals and implants to occur in the community setting, often in partnership with existing Level 4 centers.

本季度，「關懷項目」再次為成長做出了貢獻。提醒一下，CARE 致力於透過在社區環境中進行轉診和植入來擴大 RNS 的可及性，通常與現有的 4 級中心合作。

CARE activity continues to scale, and we saw sequential increases in both site engagement and implant volumes in the quarter. Given this performance, we are raising both our full year revenue and gross margin guidance ranges. For revenue, we now expect a range of $94 million to $98 million. Gross margin is now expected to be between 75% to 76%.

CARE 活動持續擴大，我們在本季看到站點參與度和植入量均持續增加。鑑於這一表現，我們提高了全年收入和毛利率的預期範圍。對於收入，我們現在預計在 9,400 萬美元到 9,800 萬美元之間。目前預計毛利率在75%至76%之間。

Additionally, during the quarter, we also completed a refinancing of our existing debt. This transaction gives us enhanced financial flexibility to fund our strategic initiatives and removes the near-term debt maturity overhang. We were pleased to secure more favorable terms, reflecting the increasing confidence from our financial partners and the improving fundamentals of our business.

此外，本季我們也完成了現有債務的再融資。此交易增強了我們的財務靈活性，為我們的策略計劃提供資金，並消除了近期債務到期負擔。我們很高興獲得更優惠的條款，這反映出我們的金融合作夥伴的信心不斷增強以及我們業務基本面的不斷改善。

Let me now turn to our clinical development programs. Our Post-Approval Study continues to resonate strongly with clinicians. Presented in April at the American Academy of Neurology meeting, it remains the largest prospectively enrolled FDA-reviewed neuromodulation study ever conducted with 324 patients and monitored using uniform and robust protocols in a focal patient population. It is high-quality evidence, and we are continuing to analyze the data set to deepen our understanding of RNS efficacy and uncover new insights.

現在讓我來談談我們的臨床開發計劃。我們的上市後研究繼續引起臨床醫生的強烈共鳴。該研究於 4 月在美國神經病學會會議上提出，至今仍是迄今為止 FDA 審查的最大規模前瞻性神經調節研究，共涉及 324 名患者，並使用統一且強大的協議在重點患者群體中進行監測。這是高品質的證據，我們正在繼續分析資料集，以加深對 RNS 功效的理解並發現新的見解。

An analysis of this Post-Approval Study data focused on generalized tonic-clonic seizures, or GTCs, within this focal epilepsy population. Generalized tonic-clonic seizures occur in focal epilepsy, as well as in idiopathic generalized epilepsy, or IGE, which we are studying with our NAUTILUS trial.

對此上市後研究數據的分析重點在於局部癲癇族群的全身性強直陣攣性癲癇發作（GTC）。全身性強直陣攣性發作發生在局部性癲癇以及特發性全身性癲癇（IGE）中，我們正在透過 NAUTILUS 試驗進行研究。

133 patients in our RNS System trials of focal epilepsy had GTCs at baseline, and the response to treatment was compelling. The median percent seizure reduction in GTCs, meaning the rate of GTC seizure reduction experienced by 50% or more of the patient population, was 100% at 24- and 36-months post implant.

在我們的 RNS 系統局部癲癇試驗中，133 名患者在基線時患有 GTC，對治療的反應非常明顯。GTC 的癲癇發作減少中位數百分比（即 50% 或更多患者群體經歷的 GTC 癲癇發作減少率）在植入後 24 個月和 36 個月為 100%。

And nearly 87% of these patients with medically intractable focal epilepsy with at least 6 months of follow-up were free of GTCs for 6 months or more. These results speak directly to the broad efficacy and real-world impact of the RNS System across seizure types. These GTC results from the PAS study will be presented at the AES meeting in December.

經過至少 6 個月的隨訪，這些患有藥物難治性局部癲癇的患者中，近 87% 的患者在 6 個月或更長時間內沒有出現 GTC。這些結果直接說明了 RNS 系統對各種癲癇發作類型的廣泛療效和實際影響。PAS 研究的這些 GTC 結果將於 12 月在 AES 會議上公佈。

Turning to NAUTILUS, our trial in patients with IGE. We continue to be highly encouraged by the data and increasingly confident in the clinical impact of the RNS System as analysis of the data progresses in this underserved population who have a high unmet clinical need. Our pre-submission documents were received and accepted by the FDA, and our submission was both thoughtful and robust and articulated how compelling and meaningful the data are for this patient population.

談到 NAUTILUS，我們對 IGE 患者進行的試驗。隨著針對此醫療服務不足且臨床需求未滿足的人群的數據分析不斷取得進展，我們繼續受到數據的極大鼓舞，並對 RNS 系統的臨床影響越來越有信心。我們的提交前文件已被 FDA 收到並接受，我們的提交內容經過深思熟慮且內容翔實，並明確表達了這些數據對於該患者群體的吸引力和意義。

Following submission, the FDA will meet with us on an accelerated time line ahead of the mandated 45-day window, which we view as a positive reflection of our ongoing engagement and collaborative relationship with the FDA. We look forward to a constructive and forward-looking discussion in the coming weeks. Based on current timelines, we continue to expect to submit our PMA supplement in the second half of 2025, in line with previous expectations.

提交後，FDA 將在規定的 45 天期限之前以加速的時間表與我們會面，我們認為這是我們與 FDA 持續合作的積極反映。我們期待在未來幾週進行建設性和前瞻性的討論。根據目前的時間表，我們仍然預計將在 2025 年下半年提交 PMA 補充文件，這與先前的預期一致。

We believe the totality of the NAUTILUS data set remains among the most compelling RNS data ever generated and reinforces our confidence in the therapy's potential in IGE. NAUTILUS was designed specifically for an IGE patient population and represents the first and only neuromodulation study, both for RNS and any other neuromodulation device for this underserved and severely impacted patient population.

我們相信，NAUTILUS 數據集仍然是有史以來最引人注目的 RNS 數據之一，並增強了我們對該療法在 IGE 中的潛力的信心。NAUTILUS 專為 IGE 患者群體設計，是針對此服務不足且受到嚴重影響的患者群體的 RNS 和任何其他神經調節設備的首次也是唯一一次神經調節研究。

The study was prospective, randomized, controlled and blinded with prespecified safety and effectiveness endpoints that provides Level 1 evidence, which is the highest standard and is required for label expansion and was recognized by the FDA when granting Breakthrough Device status.

該研究是前瞻性、隨機、對照和盲法研究，具有預先指定的安全性和有效性終點，提供了 1 級證據，這是最高標準，是標籤擴展所必需的，並在授予突破性設備地位時得到了 FDA 的認可。

As we have progressed in our analysis, the data continued to mature in a positive direction. As a reminder, the trial met its primary safety endpoint with strong safety data. It did not meet its primary effectiveness endpoint using the time-to-event design, largely due to a prespecified analysis method that was not able to account for a small subset of patients with highly variable and extremely frequent GTCs. Secondary endpoints indicate that the patient population in total experienced highly statistically significant and clinically meaningful reductions in seizure frequency.

隨著我們分析的不斷深入，數據不斷朝著正面的方向成熟。提醒一下，該試驗已達到其主要安全終點，並具有強大的安全數據。它沒有達到使用事件發生時間設計的主要有效性終點，主要是因為預先指定的分析方法無法解釋一小部分具有高度可變和極其頻繁的 GTC 的患者。次要終點表明，患者整體的癲癇發作頻率顯著降低，且具有高度統計意義和臨床意義。

Our prespecified secondary endpoints, median percent GTC seizure reduction, responder rate and seizure-free days, were all highly statistically significant with a p-value of less than 0.001 at 12 months. Median GTC seizure reduction is a highly clinically meaningful and historically important clinical trial endpoint. It is important to note that the trial is ongoing and data monitoring past 12 months is not complete.

我們預先指定的次要終點，GTC 癲癇發作減少的中位數百分比、反應率和無癲癇發作天數，均具有高度統計意義，12 個月時的 p 值小於 0.001。中位 GTC 癲癇發作減少量是一項具有高度臨床意義和歷史重要性的臨床試驗終點。值得注意的是，試驗仍在進行中，過去 12 個月的數據監測尚未完成。

While I will not cite additional specific median GTC seizure reduction percentages and follow-up time points today, respecting contemporaneous data review discussions that we are having with the regulatory agency, what I can tell you is that the median IGE/GTC seizure reduction data we have today is signaling better than 80% reduction at both 18 and 24 months. As importantly, with regard to seizure freedom from GTCs, the most dangerous type of seizure, as of the 12-month data lock for the 42 patients that had received stimulation for at least 9 months, 45.2% were seizure-free.

雖然我今天不會引用其他具體的中位 GTC 癲癇發作減少百分比和隨訪時間點，但考慮到我們與監管機構進行的同期數據審查討論，我可以告訴大家的是，我們今天掌握的中位 IGE/GTC 癲癇發作減少數據表明，在 18 個月和 24 個月時，癲癇發作減少率都超過了 80%。同樣重要的是，關於最危險的癲癇類型 GTC 的無癲癇發作情況，截至 12 個月的數據鎖定，對於接受刺激至少 9 個月的 42 名患者，45.2% 沒有癲癇發作。

With excellent safety experience in the study and prior studies of focal epilepsy, as well as the statistically significant and clinically meaningful reduction in seizure frequency and progressive improvements in seizure control, we believe there is substantial data upon which to base a benefit-risk determination. These data reinforce our belief in the differentiated impact of the RNS System in generalized epilepsy and speak to the durability and depth of treatment response in this difficult-to-treat population.

憑藉本研究和先前局部癲癇研究中的出色安全經驗，以及癲癇發作頻率在統計上和臨床上顯著的降低和癲癇控制的逐步改善，我們相信有大量數據可用於確定效益風險。這些數據強化了我們對 RNS 系統對全身性癲癇的差異化影響的信念，並說明了這種難治人群的治療反應的持久性和深度。

Let me now touch on our R&D progress, which remains a central part of our long-term value creation strategy. We continue to make progress in innovations designed to expand access, simplify therapy delivery and further differentiate the RNS platform.

現在讓我談談我們的研發進展，這仍然是我們長期價值創造策略的核心部分。我們持續在旨在擴大訪問範圍、簡化治療方式和進一步區分 RNS 平台的創新方面取得進展。

That includes progress on our first AI-powered workflow tool, our next-generation seizure classifier, and enhancements to our core RNS System. These are technologies built to improve clinical outcomes and enhance physician workflow, including more precise seizure onset detection, automated therapy setting proposals and predictive analytics to support proactive patient management.

其中包括我們第一個由人工智慧驅動的工作流程工具、下一代癲癇分類器的進展以及我們核心 RNS 系統的增強。這些技術旨在改善臨床結果和增強醫生工作流程，包括更精確的癲癇發作檢測、自動治療設定建議和預測分析，以支持主動的患者管理。

Our seizure classifier continues to learn from more than 22 million recorded events in our database, which is a unique data asset that belongs to NeuroPace and is powered by the unparalleled data capture and monitoring, made possible only by the unique monitoring and recording capabilities of the RNS System.

我們的癲癇分類器不斷從資料庫中超過 2,200 萬個記錄事件中學習，這是屬於 NeuroPace 的獨特資料資產，由無與倫比的資料擷取和監控提供支持，而這只有透過 RNS 系統獨特的監控和記錄功能才能實現。

As we continue to expand access to RNS, every additional patient placed on therapy strengthens our data set and extends our lead in this area. This creates a self-reinforcing data moat that is difficult to replicate and continues to be a core driver in delivering best-in-class outcomes that improve over time.

隨著我們不斷擴大 RNS 的使用範圍，每增加一名接受治療的患者都會增強我們的數據集並擴大我們在該領域的領先地位。這創造了一個難以複製的自我強化的數據護城河，並繼續成為提供隨著時間推移而改進的一流成果的核心驅動力。

Our long-term vision is to deliver a fully optimized AI-driven therapy experience, one that not only detects seizures, but more importantly, helps clinicians proactively manage them through data-driven insights and adaptive therapy settings. We believe this will increase efficiency and productivity for the clinicians and ultimately result in helping more patients achieve our current strong clinical outcomes faster. We continue to progress with development and regulatory efforts to launch our first AI-powered tools in 2025 and remain excited about the impact that the AI portfolio will have.

我們的長期願景是提供完全優化的人工智慧驅動的治療體驗，不僅可以檢測癲癇發作，更重要的是，幫助臨床醫生透過數據驅動的洞察和自適應治療設定主動管理癲癇發作。我們相信這將提高臨床醫生的效率和生產力，並最終幫助更多患者更快地實現我們目前良好的臨床結果。我們將繼續推動開發和監管工作，計劃於 2025 年推出我們的首款人工智慧工具，並對人工智慧產品組合將產生的影響感到興奮。

Moving on to reimbursement. In late July, CMS issued the final FY 2026 IPPS rule and elected not to finalize its proposal to reassign RNS cases into three new DRGs. As a result, RNS procedures will remain in its current DRG, thus preserving current reimbursement structure. We view this as a positive outcome relative to the proposed rule as it avoids a reimbursement uncertainty and potential challenges for hospitals treating Medicare patients. We plan to remain actively engaged with CMS to advocate for improvements to the current DRG and payment in future rule-making cycles.

繼續報銷。7 月下旬，CMS 發布了 2026 財年最終 IPPS 規則，並決定不最終確定將 RNS 病例重新分配到三個新的 DRG 的提案。因此，RNS 程序將保留在其目前的 DRG 中，從而保留目前的報銷結構。我們認為這相對於擬議規則來說是一個積極的結果，因為它避免了報銷的不確定性和治療醫療保險患者的醫院的潛在挑戰。我們計劃繼續積極與 CMS 合作，倡導在未來的規則制定週期中改進當前的 DRG 和支付方式。

Finally, we are developing our organization to ensure that we are positioned to both execute the current business at a high level and capitalize on future opportunities across product innovation, clinical advancement and market expansion. The appointments during the quarter of Patrick as our CFO and Chris Reese as our new Head of Sales reflect that commitment, bringing world-class leadership to the organization and strengthening our ability to scale.

最後，我們正在發展我們的組織，以確保我們既能夠高水準地執行當前業務，又能夠利用產品創新、臨床進步和市場擴張方面的未來機會。本季任命派崔克為我們的財務官，任命克里斯·里斯為我們的銷售主管，體現了這一承諾，為組織帶來了世界一流的領導力，並增強了我們的擴展能力。

These are intentional and strategic choices. And both judging by the caliber of the individuals we have been able to attract, as well as the impact that we're already seeing, I am both confident in and excited about the direction we are headed, both as a leadership team, as well as a business. Both Patrick and Chris bring strong industry backgrounds and are already evaluating and improving processes and leading in ways that are paying dividends. We look forward to their increasing contributions moving forward.

這些都是有意且有策略的選擇。從我們吸引到的人才的素質以及我們已經看到的影響來看，我對我們的發展方向充滿信心，也感到興奮，無論是作為領導團隊還是作為企業。派崔克和克里斯都擁有強大的行業背景，並且已經在評估和改進流程，並以帶來回報的方式進行領導。我們期待他們在未來能做出越來越多的貢獻。

RNS is a world-class technology, and we believe our opportunities are equally world-class. We are building the team to match, focused on empowering top talent to unlock the full potential of our platform. Before turning to our financial results, I would like to take a moment to thank Rebecca Kuhn for her enormous contributions to NeuroPace over her career.

RNS 是一項世界一流的技術，我們相信我們的機會同樣也是世界一流的。我們正在組建相應的團隊，專注於賦能頂尖人才，充分發揮我們平台的潛力。在介紹我們的財務表現之前，我想花點時間感謝 Rebecca Kuhn 在她的職業生涯中為 NeuroPace 的巨大貢獻。

Her leadership has been instrumental in guiding the company through pivotal moments, and her steadfast advocacy, both for our business and its mission and for the patients we serve, has left a lasting impact. We are grateful for her partnership and dedication, and I know the entire team joins me in saying thank you and wishing her continued success.

她的領導力在引導公司度過關鍵時刻方面發揮了重要作用，她對我們的業務和使命以及我們所服務的患者堅定的支持產生了持久的影響。我們感謝她的合作和奉獻，我知道整個團隊都會和我一起向她表示感謝並祝福她繼續取得成功。

With that, I will now turn the call over to Patrick Williams, our CFO, to walk through the financial results and guidance.

現在，我將把電話轉給我們的財務長 Patrick Williams，介紹財務結果和指導。

Thank you, Joel. Before I begin, let me start by saying how excited I am to be here at NeuroPace. I joined the company because I believe strongly in the mission, the strength of the data and technology, and the opportunity ahead. NeuroPace is committed to patients and high-quality evidence generation in a way that is unique in medical technology.

謝謝你，喬爾。在開始之前，請容許我先說我來到 NeuroPace 有多興奮。我加入該公司是因為我堅信公司的使命、數據和技術的力量以及未來的機會。NeuroPace 致力於以醫療技術獨特的方式為患者提供高品質的證據。

What attracted me most was the potential to help scale a platform that both improves lives and has a clear path to sustainable long-term growth and profitability. I am thrilled to be part of the team and look forward to helping the company deliver on its strategy.

最吸引我的是幫助擴大一個平台的潛力，這個平台既能改善生活，又有明確的可持續長期成長和獲利途徑。我很高興成為團隊的一員，並期待幫助公司實現其策略。

I also want to thank the broader NeuroPace team, including the finance organization and operational leaders, for the work that has been done to lay a strong foundation. The discipline in execution across the business gives us a solid base to build from, and I am energized by the momentum that is already underway. We are well positioned to continue building robust processes and tools that will support and enable NeuroPace's growth today and into the future.

我還要感謝更廣泛的 NeuroPace 團隊，包括財務組織和營運領導，為奠定堅實基礎所做的工作。整個業務的執行紀律為我們提供了堅實的基礎，而我已經為已經開始的勢頭感到振奮。我們已做好準備，繼續建立強大的流程和工具，以支持和推動 NeuroPace 目前和未來的發展。

Let me now walk you through our second quarter 2025 financial results. We reported record second quarter 2025 revenue of $23.5 million, representing 22% year-over-year growth compared to $19.3 million in the second quarter of 2024. Revenue dollar growth was primarily driven by continued strength in our core RNS System, supporting both implant volumes and broader prescriber activity.

現在讓我向您介紹我們 2025 年第二季的財務表現。我們報告稱，2025 年第二季的營收達到創紀錄的 2,350 萬美元，與 2024 年第二季的 1,930 萬美元相比年增 22%。營收成長主要得益於我們核心 RNS 系統的持續強勁，支持植入量和更廣泛的處方活動。

We also recognized an uptick in research service revenue tied to milestones related to our ongoing collaboration with Rapport Therapeutics. That collaboration has been extended and may continue to contribute small amounts of revenue in future quarters. We continue to be encouraged by the growing recognition of the value of our long-term high-quality brain activity data, which remains highly differentiated.

我們還發現，與我們與 Rapport Therapeutics 持續合作相關的里程碑相關的研究服務收入有所上升。該合作已經延長，並可能在未來幾季繼續貢獻少量收入。我們繼續受到鼓舞，因為人們越來越認識到我們長期高品質大腦活動數據的價值，儘管這些數據仍然具有高度的差異性。

We believe this is a strategic asset that not only supports innovation but is also increasingly relevant to pharmaceutical and research partners seeking better insight into neurophysiology and treatment outcomes. We will continue to be opportunistic about monetizing this data with future partners. DIXI Medical product sales continued to contribute to growth in the quarter, and as a reminder, will phase out by the end of the first quarter of 2026 or sooner, consistent with our previously communicated wind-down timeline.

我們相信，這是一項策略性資產，不僅支持創新，而且對於尋求更好地了解神經生理學和治療結果的製藥和研究合作夥伴也越來越重要。我們將繼續與未來的合作夥伴一起將這些數據貨幣化。DIXI Medical 產品銷售繼續為本季度的成長做出貢獻，值得提醒的是，該產品將於 2026 年第一季末或更早逐步淘汰，與我們先前傳達的逐步淘汰時間表一致。

We are raising our full year revenue guidance to a range of $94 million to $98 million, up from our previous guidance range of $93 million to $97 million. This updated guidance reflects an increase of approximately 18% to 23% over our reported revenue for 2024. Growth continues to be primarily driven by our RNS System. As mentioned last quarter, we are in the process of winding down our distribution agreement with DIXI Medical, and our revised guidance incorporates contribution in line with previous expectations.

我們將全年營收預期從先前的 9,300 萬美元至 9,700 萬美元上調至 9,400 萬美元至 9,800 萬美元。這項更新後的指引反映出我們 2024 年報告的營收將成長約 18% 至 23%。成長仍然主要由我們的 RNS 系統推動。正如上個季度所提到的，我們正在逐步終止與 DIXI Medical 的分銷協議，並且我們修訂後的指南納入了符合先前預期的貢獻。

Gross margin in the second quarter 2025 was 77.1% compared to 73.4% in second quarter of 2024 and 77% last quarter. Gross margin performance remains strong and reflects manufacturing efficiencies in our core RNS System with fixed overhead absorbed across higher volumes, slightly higher average selling price, as well as overall product mix. That strength was partially offset by the expected impact of lower-margin DIXI sales.

2025 年第二季的毛利率為 77.1%，而 2024 年第二季為 73.4%，上一季為 77%。毛利率表現仍然強勁，反映了我們核心 RNS 系統的製造效率，固定間接費用被更高的產量、略高的平均售價以及整體產品組合所吸收。但這優勢被 DIXI 銷售額利潤率較低的預期影響部分抵銷。

Based on our strong first half gross margins, we are raising our gross margin guidance to a range of 75% to 76%, up from our previous guidance range of 73% to 75% and expect continued favorable mix shift towards RNS sales. Looking ahead, we expect total company gross margin to trend towards 80% over time as we scale RNS volumes and the lower-margin DIXI sales are phased out of our product mix.

基於我們上半年強勁的毛利率，我們將毛利率預期從先前的 73% 至 75% 的預期範圍上調至 75% 至 76%，並預計 RNS 銷售將繼續呈現有利的組合轉變。展望未來，隨著我們擴大 RNS 銷量以及利潤率較低的 DIXI 銷售逐步退出我們的產品組合，我們預計公司總毛利率將逐漸趨向於 80%。

We believe this type of gross margin profile serves as a strong foundation for our business to continue to invest in growth, while driving towards cash flow breakeven. Total operating expenses were $25 million in the second quarter of 2025 compared to $20.4 million in the second quarter of 2024.

我們相信，這種毛利率狀況為我們的業務持續投資成長並實現現金流量收支平衡奠定了堅實的基礎。2025 年第二季總營運費用為 2,500 萬美元，而 2024 年第二季為 2,040 萬美元。

Operating expense was impacted in the quarter by one-time items totaling $1.9 million in personnel expense, including severance and recruiting related to executive transition. Stock-based compensation in the quarter totaled $3.2 million, which reflected a portion of these expenses. Excluding non-recurring items, operating expenses grew 13% year-over-year, significantly below our revenue growth in the quarter of 22%.

本季營運費用受到一次性專案的影響，總計 190 萬美元的人事費用，包括與高階主管過渡相關的遣散費和招聘費用。本季的股票薪酬總額為 320 萬美元，反映了這些費用的一部分。不包括非經常性項目，營業費用年增 13%，遠低於本季 22% 的營收成長率。

We continue to demonstrate underlying operating leverage resulting from our focus on driving revenue growth, while also effectively managing our operating expenses and gross margin. We plan to continue to focus on balancing these objectives as we drive towards cash flow breakeven.

我們繼續展示潛在的營運槓桿，這源於我們專注於推動收入成長，同時有效管理我們的營運費用和毛利率。我們計劃在努力實現現金流收支平衡的同時繼續致力於平衡這些目標。

In total, we continue to expect total operating expenses for 2025 to range between $92 million and $95 million, consistent with our previous guidance range. This range reflects 14% to 18% growth on a year-over-year basis and again, below our revenue growth rate. Included in our total operating expenses is approximately $11 million in stock-based compensation, a non-cash expense.

總體而言，我們繼續預計 2025 年的總營運費用將在 9,200 萬美元至 9,500 萬美元之間，與我們先前的指導範圍一致。這一範圍反映了同比增長 14% 至 18%，並且低於我們的收入增長率。我們的總營運費用中包括約 1,100 萬美元的股票薪酬，這是一項非現金費用。

Moving to the components of operating expense. As part of an ongoing effort and commitment to provide increased transparency and support the ability to model our business, I will break out and provide commentary on sales and marketing and general and administrative components rather than referring to SG&A as a single line item.

轉向營運費用的組成部分。作為持續努力和承諾的一部分，為了提高透明度並支持我們業務建模的能力，我將單獨對銷售和行銷以及一般和行政組成部分進行評論，而不是將銷售、一般和行政費用作為單獨的項目。

Sales and marketing expense totaled $12 million in the second quarter 2025 compared to $9.8 million in the second quarter 2024. The increase was largely due to ongoing scaling of our commercial activities and investment in direct-to-consumer advertising and other sales resources. We expect sales and marketing expense to total $46 million to $47 million for the full year 2025, driven by continued investment in our sales organization and direct-to-consumer marketing initiatives.

2025 年第二季的銷售和行銷費用總計 1,200 萬美元，而 2024 年第二季為 980 萬美元。這一增長主要歸因於我們商業活動的不斷擴大以及對直接面向消費者的廣告和其他銷售資源的投資。我們預計，2025 年全年銷售和行銷費用總計將達到 4,600 萬至 4,700 萬美元，這得益於我們對銷售組織和直接面向消費者的行銷計畫的持續投資。

R&D expense was $6.8 million in the second quarter of '25, up from $6.1 million in the second quarter of 2024 and down from $7.4 million in the first quarter of 2025. This year-over-year increase reflects increased personnel costs and continued investment in our next-generation platform, AI-powered software development, ongoing clinical trials, as well as lower grant funding compared to the prior year. We expect R&D expense to total approximately $27 million to $28 million for the full year 2025 as investment in next-generation products continues.

2025 年第二季的研發費用為 680 萬美元，高於 2024 年第二季的 610 萬美元，低於 2025 年第一季的 740 萬美元。這一同比增長反映了人員成本的增加和對下一代平台、人工智慧軟體開發、正在進行的臨床試驗的持續投資，以及與前一年相比撥款資金的減少。隨著對下一代產品的投資持續進行，我們預計 2025 年全年研發費用總計約為 2,700 萬至 2,800 萬美元。

General and administrative expense was $6.1 million in the second quarter of 2025 compared to $4.5 million in the second quarter of 2024. This year-over-year increase was again primarily driven by the previously mentioned non-recurring costs incurred in the second quarter of approximately $1.6 million. We expect G&A expense to range between $19 million and $20 million for the full year 2025.

2025 年第二季的一般及行政費用為 610 萬美元，而 2024 年第二季為 450 萬美元。這一同比增長主要再次受到前面提到的第二季度發生的約 160 萬美元的非經常性成本的推動。我們預計 2025 年全年的一般及行政費用將在 1,900 萬美元至 2,000 萬美元之間。

Loss from operations was $6.8 million in the second quarter of 2025 compared with $6.2 million in the second quarter of 2024. We recorded $2.1 million of interest expense in the second quarter of 2025 compared to $2.2 million in the second quarter of 2024. Following the successful refinancing of our debt on improved terms, we now expect interest expense of approximately $8 million for the full year 2025.

2025 年第二季的營業虧損為 680 萬美元，而 2024 年第二季的營業虧損為 620 萬美元。2025 年第二季我們的利息支出為 210 萬美元，而 2024 年第二季的利息支出為 220 萬美元。在以更好的條件成功對債務進行再融資後，我們預計 2025 年全年的利息支出約為 800 萬美元。

On an annualized basis, we anticipate interest expense will improve by approximately $2 million due to improved terms on our new debt. Regarding interest income, we expect approximately $2.5 million in income for the full year 2025. Net loss was $8.7 million for the second quarter of 2025 compared to a net loss of $7.5 million in the second quarter of 2024.

按年計算，由於新債務條款的改善，我們預計利息支出將減少約 200 萬美元。關於利息收入，我們預計 2025 年全年收入約為 250 萬美元。2025 年第二季淨虧損為 870 萬美元，而 2024 年第二季淨虧損為 750 萬美元。

Our free cash flow, or what has historically been described as cash burn, was negative $2.3 million in the second quarter of 2025 compared to negative $4 million in the second quarter of 2024. This year-over-year improvement was primarily driven by higher revenue and gross margins as the business continues to show leverage.

我們的自由現金流，或歷史上被描述為現金消耗，在 2025 年第二季為負 230 萬美元，而 2024 年第二季為負 400 萬美元。年成長主要得益於業務持續展現槓桿作用，從而帶來更高的收入和毛利率。

Finally, ending with our balance sheet, our cash and short-term investments balance as of June 30, 2025 was $62.1 million. In addition, our recently refinanced debt provides access to an undrawn $15 million revolver. Combined, we believe this gives us sufficient capacity to fund operations through cash flow breakeven.

最後，以我們的資產負債表結束，截至 2025 年 6 月 30 日，我們的現金和短期投資餘額為 6,210 萬美元。此外，我們最近再融資的債務提供了 1500 萬美元未提取的循環信貸額度。綜合起來，我們相信這將使我們有足夠的能力透過現金流損益平衡來資助營運。

With that, I would now like to turn the call back over to Joel for closing remarks.

好了，現在我想把電話轉回喬爾，請他做最後發言。

Thank you, Patrick. To close, I'll reiterate a few key themes. First, our strategy is working. We continue to see meaningful progress across market development, clinical development and product development, all of which we view as world-class opportunities. These opportunities strengthen our position to deliver outsized impact for patients, physicians and the business.

謝謝你，派崔克。最後，我將重申幾個關鍵主題。首先，我們的策略正在發揮作用。我們在市場開發、臨床開發和產品開發方面繼續取得有意義的進展，我們將所有這些都視為世界級的機會。這些機會加強了我們為病人、醫生和企業帶來巨大影響的地位。

The investments we've made in the base business and disciplined execution is delivering consistent results today, and we believe that momentum will continue to build in the second half of 2025 and into 2026 and beyond. Second, we continue to take steps to strengthen the organization. We added strong new leadership in finance and commercial, and we are investing in organizational development to ensure we're positioned to both execute the current business at a high level and capitalize on future opportunities.

我們在基礎業務和嚴格執行方面所做的投資目前正在產生持續的成果，我們相信這種勢頭將在 2025 年下半年、2026 年及以後繼續增強。二是繼續採取措施加強組織建設。我們在財務和商業領域增加了強大的新領導層，並且我們正在投資組織發展，以確保我們能夠高水準地執行當前業務並利用未來的機會。

Third, we remain committed to innovation. Through data-driven enhancements to the RNS platform, advancing new indications like IGE and pediatrics or AI-enabled features to enhance the product and workflow, we are pushing forward and leading the field on multiple fronts with patient outcomes at the center of everything we do.

第三，我們堅持創新驅動。透過對 RNS 平台進行數據驅動的增強，推進 IGE 和兒科等新適應症或 AI 支援的功能以增強產品和工作流程，我們正在多個方面推動和引領該領域，並將患者結果置於我們所做的一切的中心。

I have never felt more confident in our plans, the execution of those plans, and the current and future growth of the RNS System than I do right now. We expect to update our long-range outlook, inclusive of the divestiture of DIXI once we have full visibility into 2025, but the long-range strategic direction that we articulated in January at our Investor Day remains in place and on track.

我對我們的計劃、這些計劃的執行以及 RNS 系統的當前和未來發展從未像現在這樣充滿信心。一旦我們對 2025 年有了全面的了解，我們預計將更新我們的長期展望，包括剝離 DIXI，但我們在 1 月份投資者日上闡明的長期戰略方向仍然有效並正在按計劃進行。

Our strategy focused on RNS is clear. It is correct, and we are focused on executing it to the significant benefit of patients, clinicians who care for them and shareholders. Thanks again for your time today and for your continued interest in NeuroPace.

我們專注於 RNS 的策略很明確。這是正確的，我們致力於執行它，為病人、照顧他們的臨床醫生和股東帶來重大利益。再次感謝您今天抽出時間以及對 NeuroPace 的持續關注。

Operator, we'll now open the line for questions.

接線員，我們現在可以開始回答問題了。

(Operator Instructions)

（操作員指示）

Rohin Patel, JPMorgan.

摩根大通的 Rohin Patel。

Hi. Thanks so much for taking the question. I have one just to start off on IGE. I just wanted to ask on your FDA submission strategy. Last we talked, I believe, you were considering kind of a multipronged approach to the submission, just given the data looked a little bit better in the subset of patients that had a lower baseline seizure frequency.

你好。非常感謝您回答這個問題。我有一個剛開始使用 IGE 的。我只是想詢問一下你們的 FDA 提交策略。我相信，上次我們談話時，您正在考慮採用多管齊下的方法來提交，因為在基線癲癇發作頻率較低的患者子集中，數據看起來會更好一些。

So maybe just the first question for me is, could you just talk a bit more about your submission strategy? Are you still going for a broad indication approval or something a little bit more segmented? And then, I had a follow-up.

所以也許對我來說第一個問題是，您能否再多談談您的提交策略？您還在尋求廣泛的適應症批准還是更細分的批准？然後，我進行了後續跟進。

Hi, Rohin, thank you for the question. So our strategy remains the same, where our plan is to go for an indication involving the totality of the data and the totality of the population, with the clinically meaningful and statistically significant treatment effect that we see in the prespecified secondary endpoints points clearly to the entire population demonstrating benefit, and that's our plan is to pursue an indication across the population.

你好，Rohin，謝謝你的提問。因此，我們的策略保持不變，我們的計劃是尋求涉及全部數據和全部人口的適應症，我們在預先指定的次要終點中看到的具有臨床意義和統計意義的治療效果清楚地表明整個人口都顯示出益處，這就是我們的計劃，即在整個人口中尋求適應症。

Thank you. And then, I guess just a follow-up on gross margin. I mean, it came in a bit higher than I think people were expecting, and you obviously had some good leverage in the quarter. So can you just talk a little bit about kind of the outlook for second half? I believe kind of the new guide still implies a bit of a decline in gross margin. Is that just due to conservatism? Or is there anything specific to call out? And how are you thinking about kind of this higher run rate or higher gross margin translating into potential earlier cash flow breakeven beyond 2025? Thanks.

謝謝。然後，我想這只是對毛利率的後續關注。我的意思是，它比人們預期的要高一些，而且你在本季顯然擁有一些良好的槓桿作用。那麼，您能否簡單談談下半年的前景呢？我認為新的指南仍然意味著毛利率會下降。這僅僅是由於保守主義嗎？或是有什麼特別需要強調的嗎？您如何看待這種更高的運轉率或更高的毛利率轉化為 2025 年後更早實現現金流收支平衡的可能性？謝謝。

I'll ask Patrick to comment here, Rohin, but what I'll offer as a starting point is, we're obviously pleased with the gross margin performance. And you've heard us talk about the key drivers there in the past in terms of absorption and consistent contracting and pricing.

我會請派崔克在這裡發表評論，羅欣，但我首先要說的是，我們顯然對毛利率表現感到滿意。您也聽過我們談論過去在吸收、一致承包和定價方面的關鍵驅動因素。

And in addition to what we see a strong performance here in the quarter, I'd point to the RNS gross margin number, that north of 80% number. And as you think about the mix of the business and where we're headed with it, particularly pleasing to me was seeing that RNS gross margin performance. Patrick, what would you want Rohin and everybody on the line to know?

除了本季我們看到的強勁表現之外，我還要指出的是 RNS 毛利率數字，也就是 80% 以上的數字。當您考慮業務組合和我們的發展方向時，令我特別高興的是看到 RNS 的毛利率表現。派崔克，你想讓羅欣和電話裡的每個人都知道什麼？

No, we're really pleased with it. And I think, Rohin, you hit the nail on the head. Our guidance, although we did increase it quite a bit, it would imply potentially a deceleration, and I would not read more of that other than us being very thoughtful and not wanting to get ahead of ourselves. There could be a little bit of a mix issue. We continue to see very strong margins on the service side.

不，我們對此非常滿意。我認為，羅欣，你說到了點子上。我們的指導意見雖然確實提高了不少，但這可能意味著減速，除了我們非常深思熟慮並且不想超越自己之外，我不會讀到更多這樣的內容。可能存在一點混合問題。我們繼續看到服務方面的利潤率非常高。

But I think the most pleasing thing is related to what Joel just said, which is, I've always looked at 80% as sort of a benchmark for medical device companies to strive towards. And as we divest the DIXI revenue moving into 2026, we see no reason why we can't start pushing at that 80% or even a little bit higher than that.

但我認為最令人高興的事情與喬爾剛才所說的有關，那就是，我一直將 80% 視為醫療器材公司努力追求的基準。隨著我們在 2026 年剝離 DIXI 收入，我們認為沒有理由不能開始推動 80% 甚至更高一點。

In terms of cash flow, just to hit that real quick, yeah, gross margins are certainly going to help us, as well as the fact that our revenue continues to grow, which, of course, is compelling. At the same time, the reservicing and the refinancing of the debt is saving us about $2 million of cash interest expense annually. And so, that's just another tailwind that we have that continues to push us towards our longer-term strategy of getting to cash flow breakeven as we move out of 2027.

就現金流而言，只是為了快速達到這一點，是的，毛利率肯定會對我們有幫助，而且我們的收入還在持續增長，這當然是令人信服的。同時，債務的準備金和再融資每年為我們節省約 200 萬美元的現金利息支出。所以，這只是我們的另一個順風，它將繼續推動我們實現我們的長期策略，即在 2027 年實現現金流收支平衡。

Great. Thank you so much.

偉大的。太感謝了。

Priya Sachdeva, UBS.

Priya Sachdeva，瑞銀。

Hi, guys. Thanks for the question and congrats on a great quarter. I guess, my first one is, you talked about the contribution from Project CARE. But I'd love to hear some of the dynamics with the existing base and particularly those more adept centers and what you've seen in terms of implant volume shifts, whether it's growth or kind of stabilization and the contributions from an expanding funnel of Project CARE. Any color there would be super helpful. And then, one follow-up.

嗨，大家好。感謝您的提問，並祝賀本季度取得了出色的成績。我想，我的第一個問題是，您談到了來自 CARE 專案的貢獻。但我很想聽聽現有基礎的一些動態，特別是那些更熟練的中心，以及您在植入物數量變化方面所看到的情況，無論是增長還是穩定，以及來自 Project CARE 不斷擴大的渠道的貢獻。任何顏色都會非常有用。然後，進行一次跟進。

Thank you, Priya. Yeah, we were pleased with what we saw from CARE here in the quarter. And in particular, we were pleased with the implant growth rate that we saw, so strong implant contribution from CARE in the quarter, and I think really kind of rounding into form there as a number of centers begin to contribute more fully on implants as well as referrals. So you're exactly right. We did see more from the existing base of CARE accounts, and in particular, I'd point to implant volumes from CARE in the quarter.

謝謝你，普里亞。是的，我們對本季 CARE 的表現感到滿意。特別是，我們對看到的植入物增長率感到滿意，因此本季度 CARE 對植入物的貢獻非常強勁，而且我認為隨著許多中心開始在植入物和轉診方面做出更充分的貢獻，植入物增長率確實呈逐漸上升的趨勢。所以你說得完全正確。我們確實從現有的 CARE 帳戶基礎中看到了更多成長，特別是本季來自 CARE 的植入量。

Okay. Awesome. And Patrick, congrats on your first call with the team. Looking forward to working with you. Would love to hear just some of the puts and takes to the guidance. The midpoint does imply a modest step-down in second half growth versus the first half. So any dynamics exiting the second quarter that we should be considering? We're inclined to think that this momentum should continue, but any color would be helpful.

好的。驚人的。派崔克，恭喜你第一次與團隊通話。期待與您合作。很想聽聽對該指導的一些看法。中點確實意味著下半年的成長與上半年相比會略有放緩。那麼，我們應該考慮第二季出現哪些動態呢？我們傾向於認為這種勢頭應該會持續下去，但任何顏色都會有幫助。

Yeah. No, thank you, and I'm very happy to be here. I think what you're looking at when you think about those numbers are percentages. And so, we had some tough comps from the Q3 a year ago in 2024. But what I would say once again is us just being very thoughtful and prudent as we think about guidance.

是的。不，謝謝，我很高興來到這裡。我認為當您考慮這些數字時您看到的是百分比。因此，我們與去年 2024 年第三季相比有一些艱難的比較。但我想再次強調的是，我們在考慮指導時要非常深思熟慮和謹慎。

We did raise both the low end of guidance and the high end by $1 million. To be fair, DIXI revenue is in there. And so, we wanted to be thoughtful about what they may look like. We do finish that contract at the end of Q3, and there is a six-month wind-down. And so, there could be a little bumpiness there. So we just wanted to make sure that we were being thoughtful around that. But I would say, overall, we feel very good with the RNS strategy, off to a great start in Q3, and we look forward to reporting another strong quarter in the next 90 days.

我們確實將指導價的低端和高端都提高了 100 萬美元。公平地說，DIXI 的收入也在其中。因此，我們想仔細考慮它們的外觀。我們確實在第三季末完成了該合同，並且有六個月的結束期。因此，那裡可能會有點顛簸。所以我們只是想確保我們對此深思熟慮。但我想說，總的來說，我們對 RNS 策略感到非常滿意，第三季取得了良好的開端，我們期待在未來 90 天內再次報告強勁的季度業績。

Great. Thank you so much.

偉大的。太感謝了。

Vik Chopra, Wells Fargo.

維克喬普拉，富國銀行。

Hey, good afternoon and thanks for taking the questions and congrats on a nice quarter as well. I guess, my first question is, the data that we saw from NAUTILUS, I'm just curious if you have seen any impact to your commercial momentum since you released that preliminary data. Has this [tainted doctor's] view of the product and any impact to focal growth? And then, I had a quick follow-up, please.

嘿，下午好，感謝您回答問題，也祝賀您本季取得了良好的業績。我想，我的第一個問題是，我們從 NAUTILUS 看到的數據，我只是好奇自從您發布初步數據以來，您的商業勢頭是否受到了任何影響。這位[受污染的醫生]對產品的看法對焦點成長有什麼影響嗎？然後，請容許我快速跟進。

Thanks for the question, Vik. And what -- I would say, absolutely no. And again, to my earlier comments, we think the NAUTILUS data is among some of the strongest we've ever seen with RNS. And if you think about the level of median seizure reduction, the level of seizure freedom that we're seeing across a never-before studied with this kind of a controlled approach patient population, the level of seizure freedom, again, that we're seeing, in particular, from investigators that are close to it as we've done our investigator review calls, seeing just, in fact, the opposite, a lot of enthusiasm from people about what they're seeing here with regard to the IGE data. In the end, it's a time-to-event primary efficacy and variability in a small subgroup of patient issue associated with the primary effectiveness endpoint.

謝謝你的提問，維克。我想說的是，絕對不是。再次重申我之前的評論，我們認為 NAUTILUS 數據是我們在 RNS 中見過的最強大的數據之一。如果你考慮一下中位癲癇發作減少的水平，即我們在這種受控方法研究的患者群體中看到的癲癇發作自由水平，再一次，我們看到的癲癇發作自由水平，特別是從接近它的研究人員那裡看到的，因為我們已經完成了研究人員審查電話，事實上，我們看到的情況恰恰相反，人們對他們在 IGE 數據方面看到的內容非常熱情。最後，它是與主要有效性終點相關的一小部分患者問題的事件發生時間主要功效和變異性。

And I think clinicians -- certainly, investigators and clinicians that we hear from recognize that clinical trial design and patient population inclusion dynamic and quickly read through that to the clinical meaningfulness and the statistical significance of those prespecified secondary endpoints. When people think about what are they looking for from a treatment, they're not looking for sitting down and talking with a patient about impacting the time to their second GTC.

我認為臨床醫生——當然，我們聽到的研究人員和臨床醫生認識到臨床試驗設計和患者群體納入動態，並快速讀懂這些預先指定的次要終點的臨床意義和統計意義。當人們思考他們希望從治療中獲得什麼時，他們並不是想坐下來與患者談論如何影響他們第二次 GTC 的時間。

They're looking to talk to patients about the median -- the level of seizure frequency reduction, the level of seizure-free days, the amount of seizure freedom they may experience. Those are the real clinical impactors from the treatment, and that's what we're seeing, such strong and highly statistically significant as well as clinically meaningful results. And so, I would say no, absolutely not. And in particular, it's been gratifying to see the responses from the investigators who are really close to the individual patients and the data.

他們希望與患者討論中位數——癲癇發作頻率降低的水平、無癲癇發作天數的水平以及他們可能經歷的癲癇發作自由的程度。這些是治療的真正臨床影響因素，這就是我們所看到的如此強大且具有高度統計意義和臨床意義的結果。所以，我會說不，絕對不是。尤其令人欣慰的是，看到那些真正了解個別患者和數據的研究人員的回應。

That's great to hear. And my follow-up question is for Patrick. Patrick, the LRP targets that were put out this year, they were put in place before you started. You've been in the CFO seat for, I guess, not that long now, but would love to get your thoughts on whether you see these targets as achievable and a gauge of your confidence in these goals. Thank you.

聽到這個消息真是太好了。我的後續問題是針對派崔克的。派崔克，今年提出的 LRP 目標在你開始工作之前就已經制定好了。我想，您擔任財務長的時間還不算太長，但我很想聽聽您的看法，看看您是否認為這些目標是可以實現的，以及您對這些目標的信心如何。謝謝。

Yeah, fair question, and I think we addressed some of it during the prepared comments. But look, I'm in the seat now for a couple of months. And as I dive into the business and better understand the opportunity that we have with our core RNS System, I have a lot of conviction around that. I believe that the 20% CAGRs that we talked about when it comes to RNS are achievable. And I believe we can hit those numbers without necessarily getting expanded indications.

是的，公平地問這個問題，我認為我們在準備好的評論中已經解決了其中的一些問題。但是你看，我已經在這個職位上待了幾個月了。當我深入研究業務並更了解我們的核心 RNS 系統所帶來的機會時，我對此充滿信心。我相信，我們在談到 RNS 時談到的 20% 複合年增長率是可以實現的。我相信我們可以達到這些數字，而不必擴大適應症。

And so, as Joel said, we will continue to go through this year and provide some updates because, obviously, we are going to divest from DIXI, which was a decent percentage of our revenue for 2025. And from that point forward, we will align the numbers with everyone, but we're feeling very good about where we're at with RNS. And of course, as we look to go with general indication and then eventually pediatrics, I think that's an increased tailwind behind us but certainly would turn it over to Joel to see if he has any parting comments on that.

因此，正如喬爾所說，我們將繼續度過今年並提供一些更新，因為顯然我們將從 DIXI 撤資，這占我們 2025 年收入的相當大一部分。從那時起，我們將與每個人協調數字，但我們對 RNS 的現狀感到非常滿意。當然，當我們著眼於一般適應症，最終是兒科時，我認為這對我們來說是一個更大的順風，但我肯定會把它交給喬爾，看看他對此是否有任何最後評論。

I would just emphasize, the business we've got today with the customers we've got today, the indications we've got today is delivering us a consistently growing business at 20%-plus. And we're -- we think we can do better and do more than that. I'm not guiding, but we think we can do better and do more than that with what we've got today.

我只想強調，我們今天與客戶開展的業務以及我們今天所獲得的跡象表明，我們的業務將以 20% 以上的速度持續成長。而且我們認為我們可以做得更好，做得更多。我不是指導者，但我們認為，憑藉我們今天所擁有的，我們可以做得更好，做得更多。

And then, we start adding on clinical indication expansion, we start adding on product development pipeline. We start adding on execution and focus from the team that we're developing. And I think our -- my own confidence is building.

然後，我們開始增加臨床適應症擴展，開始增加產品開發管道。我們開始在正在發展的團隊中增加執行力和關注度。我認為我們的——我自己的信心正在增強。

Mike Kratky, Leerink Partners.

麥克‧克拉基 (Mike Kratky)，Leerink 合夥人。

Hey, everyone. This is Sam on for Mike. Thanks for taking our questions. Just in terms of NAUTILUS, can you kind of just provide a little bit more color on your ongoing dialogue with the FDA today, what the specific feedback from them has been so far and kind of what you hope to accomplish in your upcoming discussions with them in the coming weeks? And then, I have a follow-up.

嘿，大家好。這是 Sam 為 Mike 代言。感謝您回答我們的問題。就 NAUTILUS 而言，您能否稍微詳細介紹一下您今天與 FDA 正在進行的對話，到目前為止他們的具體反饋是什麼，以及您希望在未來幾週與他們的討論中取得什麼成果？然後，我有一個後續問題。

You bet. Thanks, Mike, and congratulations. So the NAUTILUS State of the Union is that we have been in contact with the agency and our Q-Sub documents have been submitted. They have been accepted by the FDA. We have gotten a response from them, a very timely response from them in terms of meeting dates and options.

當然。謝謝，麥克，恭喜你。因此，NAUTILUS 國情咨文是，我們已經與該機構取得聯繫，並且我們的 Q-Sub 文件已經提交。它們已被FDA認可。我們收到了他們的回复，他們在會議日期和選項方面給予了非常及時的回复。

We have settled on a date, and we've been really pleased with the level of engagement from the agency and the level of collaboration that, frankly, has developed over years. Our team works closely with the agency. I think they recognize the quality of the company and the quality of the way that we've worked to build a relationship with them. And so, that's been very pleasing to us. We plan to cover just to the things that we're talking about here with the agency.

我們已經確定了日期，並且我們對該機構的參與程度以及坦率地說多年來發展起來的合作水平感到非常滿意。我們的團隊與該機構密切合作。我認為他們認可公司的品質以及我們為與他們建立關係所付出的努力。所以，這讓我們非常高興。我們計劃只討論我們與該機構正在討論的事情。

We spent a lot of time doing analysis, as well as generating thoughtful insights in terms of what we're seeing in the data, both as it relates to the primary efficacy endpoint with the safety results, the primary efficacy endpoint results, and the statistical analysis around that, and then, again, the really encouraging data that we're seeing with the prespecified secondary endpoints of median GTC seizure reduction responder rate and seizure-free days. So we'll be working our way through all of those things and then listening for and hearing any feedback and questions that they have.

我們花了大量時間進行分析，並根據我們在數據中看到的內容得出了深刻的見解，既包括與主要療效終點相關的安全性結果、主要療效終點結果以及圍繞該結果的統計分析，也包括我們在預先指定的次要終點（即 GTC 癲癇發作減少反應率中位數和無癲癇發作天數）中看到的真正令人鼓舞的數據。因此，我們將努力解決所有這些問題，然後傾聽並聽取他們的回饋和問題。

Got it. That's very clear. Thanks for the color there. And then, just as a follow-up, I wanted to turn to Project CARE. How long does it typically take to transition a community center, kind of a meaningful contributor of implant volumes? What does that ramp and learning curve typically look like? And what kind of things need to get put in place before that meaningful ramp can happen?

知道了。這很清楚。感謝那裡的色彩。然後，作為後續行動，我想轉向 Project CARE。通常需要多長時間才能將社區中心轉變為植入有意義的貢獻者？這個坡度和學習曲線通常是什麼樣的呢？那麼，在實現這一有意義的成長之前，需要先做好哪些準備呢？

It's a really good question, and I've talked about this a little bit previously. But I think we see really kind of three segments of care centers: one, centers that are really pretty much ready to go. They've got what they need in terms of infrastructure, clinicians and patient populations, and it's really kind of a contracting and training exercise, which is the same as the training we do whenever we start centers. And so, that's really a pretty standard process. We know how to do that, and customers are well equipped to do so.

這是一個非常好的問題，我之前已經談過這個問題了。但我認為我們看到的護理中心實際上分為三類：第一類是已經準備好的中心。他們已經具備了所需的基礎設施、臨床醫生和患者群體，這實際上是一種承包和培訓活動，與我們每次開設中心時進行的培訓相同。所以，這確實是一個非常標準的過程。我們知道如何做到這一點，而且客戶也完全有能力做到這一點。

That segment can occur pretty quickly and is really just dependent on, again, the contracting and training logistics in detail. The second group that we see is a group that takes a little bit longer but -- and they're going to be ready, but it maybe is a group that has to put in place a specific level of functionality or is waiting to bring in another neurosurgeon and expand capacity, et cetera.

該部分可以很快發生，並且實際上僅取決於詳細的承包和培訓物流。我們看到的第二組是需要更長一點時間的組，但是 - 他們已經做好準備，但可能是一個必須實現特定級別功能的組，或者正在等待引入另一位神經外科醫生並擴大容量等。

So that can take a little bit longer to get those folks up and implanting. And then, the third segment has been an interesting one where we actually see centers who -- really what they want to do is, they want to be programming centers. They've got the patient population. They want those patients to get RNS therapy, and they want to be able to get those patients back and manage them, but they're happy to have a relationship established with a Level 4 center for the implants to take place.

因此，讓這些人站起來並進行植入可能需要更長的時間。然後，第三部分很有趣，我們實際上看到了中心——他們真正想做的是，他們想成為程式設計中心。他們擁有患者群體。他們希望這些患者能夠接受 RNS 治療，他們希望能夠讓這些患者回來並進行治療，但他們很高興與 4 級中心建立關係以進行植入。

And so, that's a long way around, Sam, towards saying that there's variability in terms of how long it takes based on the segment of the center and that -- and where they fall individually. But I think we've learned a lot here over the past number of months, and we're in position to be able to respond to any of those.

所以，山姆，這是一個很長的話題，也就是說，根據中心的各個部分以及它們各自所在的位置，所需的時間存在差異。但我認為，在過去的幾個月裡，我們已經學到了很多東西，我們有能力應對其中的任何問題。

That's very helpful. Thanks, guys.

這非常有幫助。謝謝大家。

And sorry about that, Sam. Please pass along our congratulations to Mike.

對此我很抱歉，山姆。請向麥克轉達我們的祝賀。

Frank Takkinen, Lake Street Capital Markets.

Frank Takkinen，湖街資本市場。

Thanks for taking the questions. [No long-range] plan has come up a few times on the call. So I just wanted to come back to it once more. I mean, with the exiting of DIXI, which is, I think if I'm remembering correctly, about $14 million of revenue in 2024, just below that level, it kind of implies you got to accelerate that RNS growth to right closer to the 30% range if you want to start to be more in line with the long-range plan that has been outlined.

謝謝你們回答問題。電話會議中幾次提到了「沒有長期計劃」。所以我只是想再回到這個問題。我的意思是，隨著 DIXI 的退出，如果我沒記錯的話，2024 年的收入約為 1400 萬美元，略低於該水平，這意味著如果你想開始更符合已概述的長期計劃，你必須將 RNS 增長加速到接近 30% 的範圍。

I understand you kind of said you're going to update those metrics, but help us with the puts and takes. And is that 20% target you put out there over kind of a longer period of time? Or is that kind of consistent year-to-year? And how is that going to be impacted by DIXI? And what can you do to drive stronger core growth to kind of fulfill that?

我明白您說過您將要更新這些指標，但請幫助我們處理投入和產出。您設定的 20% 目標是否是在較長時間內達成的？或者說這種現象每年都保持一致？DIXI 會對此產生什麼影響？那麼，您可以做些什麼來推動更強勁的核心成長，從而實現這一目標呢？

Thank you, Frank. It's a great question. It's exactly what we were addressing there in our comments. We do plan to update all of that as we get a more fulminant view of 2025. And so, I won't try to specifically update those numbers here today until we get to that point.

謝謝你，弗蘭克。這是一個很好的問題。這正是我們在評論中討論的內容。隨著我們對 2025 年有了更清晰的認識，我們確實計劃更新所有這些內容。因此，在我們達到這一點之前，我今天不會嘗試在這裡具體更新這些數字。

But to your point of the puts and takes associated with that and the 20% growth rate that we've articulated in terms of our long-range plan targets, we're absolutely convinced that we can grow the RNS business that we have at north of 20% with what we've got today. We're doing it.

但對於您提到的與此相關的利弊以及我們在長期計劃目標中闡明的 20% 的增長率，我們絕對相信，我們可以憑藉現有的實力將 RNS 業務增長 20% 以上。我們正在做這件事。

That business is growing like that. We've demonstrated that, and we've got plenty of market opportunity and potential for the team to execute with the capacity that we have in the organization to continue to do so. And I think we can then build on that growth rate with everything that we talked about at the Investor Day that we went through together.

那個生意就這樣發展著。我們已經證明了這一點，並且我們擁有足夠的市場機會和潛力，讓團隊能夠利用我們組織的能力繼續這樣做。我認為，我們可以利用投資者日上討論過的所有問題來鞏固這一增長率。

That is all still exactly the plan. And we think that, that plan can result in increasing growth rates over the planned period. And that's our plan. So we will do all of that. My answer here today won't be fully satisfying, but that's our plan, and we're very bullish about both the baseline 20% growth rate, as well as accelerating growth over the longer term. And I'll ask Patrick to add any his commentary as well.

這一切仍舊按照計劃進行。我們認為，該計劃可以提高計劃期內的成長率。這就是我們的計劃。所以我們會盡力做到這一切。我今天的回答不會完全令人滿意，但這是我們的計劃，我們對基準 20% 的成長率以及長期加速成長都非常樂觀。我還請帕特里克添加他的評論。

Yeah. I think to be crystal clear here, when the Investor Day happened in January, DIXI revenue was clearly in there. And Frank, you stated as a percentage of what it was in '24, and those percentages are pretty consistent. We're kind of in that mid-teen revenue as a percent of contribution even through '25. So clearly, we are divesting away from that.

是的。我認為這裡要非常清楚的是，當一月份投資者日舉行時，DIXI 的收入顯然在其中。弗蘭克，您說的是 24 年的百分比，這些百分比相當一致。即使到 25 年，我們的收入佔貢獻的比例也處於十幾歲左右。顯然，我們正在放棄這一點。

We will be losing that revenue as we exit '25 and going into '26. And so, what you're hearing from us is a conviction that RNS at a minimum has the ability to grow at 20%, and we are continuing to stick with that as we did during the Investor Day in January. And as we get better insight into finishing out this year with some of the stuff that we've already addressed, as we get a better understanding of how CARE can help out and other such programs, including making this easier for physicians and indication expansion, et cetera, then we'll come back and look to update.

當我們退出 25 年並進入 26 年時，我們將會失去這些收入。因此，您從我們這裡聽到的是，我們堅信 RNS 至少有能力成長 20%，而且我們將繼續堅持這一觀點，就像我們在一月份的投資者日期間所做的那樣。隨著我們對今年已經解決的一些問題有了更深入的了解，隨著我們對 CARE 如何提供幫助和其他類似計劃（包括讓醫生更容易完成這些工作和擴大適應症等）有了更好的理解，我們會回來尋求更新。

But I want to be clear that DIXI was part of the LRP before, and we do need to address that as we move forward, but we feel very confident at 20%-plus for RNS. Is that clear, Frank?

但我想明確一點，DIXI 以前是 LRP 的一部分，我們確實需要在前進的過程中解決這個問題，但我們對 RNS 的 20% 以上非常有信心。明白了嗎，弗蘭克？

Yes. That's perfect. I appreciate the color. And then, maybe just one follow-up on Project CARE. I think last quarter, it came up that there's increased success in kind of overlay direct-to-patient in Project CARE geographies. Maybe update us on this concept. How has that trended more recently? And maybe what would cause you to maybe kind of double down on Project CARE and DTP in later this year or maybe 2026?

是的。那很完美。我很欣賞這個顏色。然後，也許只是對 Project CARE 的跟進。我認為上個季度，在 Project CARE 地區，直接面向患者的覆蓋方式取得了更大的成功。也許可以向我們介紹一下這個概念。最近的趨勢如何？那麼，什麼原因會促使您在今年稍後或 2026 年加倍投入 Project CARE 和 DTP 呢？

Great question. And we absolutely continue to pursue that strategy, Frank. I think we're getting dialed in on those algorithms and our ability to really target and engage patients on a very geographic-specific basis. And so, we do see direct-to-patient, as well as direct-to-patient in a community setting, having the potential to drive volume toward care centers, as well as drive referral volume through Level 4 centers as well.

好問題。我們絕對會繼續推行這項策略，弗蘭克。我認為我們正在利用這些演算法以及我們真正在特定地理區域內定位和吸引患者的能力。因此，我們確實看到直接面向患者以及在社區環境中直接面向患者的服務有潛力推動醫療中心的醫療量，以及推動透過 4 級中心的轉診量。

So we have previously commented that in some of the elasticity testing that we've done around direct-to-patient, we thought we had seen a response there. And I continue to be encouraged that we are seeing that kind of a response. And so, we view direct-to-patient as an important element of continuing to build our patient pipeline.

因此，我們之前曾評論說，在我們針對直接面向患者進行的一些彈性測試中，我們認為我們已經看到了反應。我很高興看到我們得到了這樣的回應。因此，我們將直接面向患者視為持續建立患者​​管道的重要因素。

That's helpful. Thank you for taking the question.

這很有幫助。感謝您回答這個問題。

Ross Osborn, Cantor Fitzgerald.

羅斯奧斯本、康托費茲傑拉。

Hey, guys. Congrats on the progress and thanks for taking the questions. So starting off on the R&D side of the house, would you remind us on where you stand in the development side of things for your next-gen RNS offering? And what areas of improvement you are focused on?

嘿，大家好。恭喜您的進展並感謝您回答問題。那麼從研發方面開始，您能否提醒我們您在下一代 RNS 產品開發的立場？您重點關注哪些改進領域？

So we talked about in January, Ross, the next-generation platform, that platform providing a number of enhancements, including some increased capacity, as well as then flexibility with Bluetooth communications and ease of use in particular. And all of that is on track. We continue to make good progress there, and we're on the timelines that we had laid out at that point. It's a longer-term hardware and implant development project, as we had discussed. But that's all going real well.

因此，我們在一月份討論了 Ross 的下一代平台，該平台提供了許多增強功能，包括增加一些容量，以及藍牙通訊的靈活性和易用性。一切進展順利。我們在那裡繼續取得良好進展，並且正在按照當時制定的時間表進行。正如我們所討論的，這是一個長期的硬體和植入物開發項目。但一切都進展順利。

We're -- just a little bit more detail maybe. We're in the stage now where we're really testing and characterizing a lot of the key componentry that goes into the system. And that's been coming back at or above our expectations. And so, I feel really good about where we're at with the development of the second-generation platform.

我們——也許只是稍微詳細一點。我們現在正處於對系統中許多關鍵組件進行實際測試和描述的階​​段。這已經達到或超越了我們的預期。因此，我對第二代平台的開發進展感到非常滿意。

Great. And then, turning to potential therapeutic partnerships. Based upon your conversations, is this an area we should expect to come into the model next year in a material manner or more so in the out years?

偉大的。然後，轉向潛在的治療夥伴關係。根據您的談話，我們是否應該期望這個領域明年或未來幾年以實質的方式進入模型？

I won't necessarily comment on materiality, Ross, but I will say that we see the collaboration opportunity as more than report. In fact, we have signed an agreement with UCB -- some of you may be familiar with UCB, one of the largest pharmaceutical companies in the space -- for another collaboration arrangement here. And there's more on the way.

羅斯，我不一定會評論實質問題，但我會說，我們認為合作機會不僅僅是一份報告。事實上，我們已經與 UCB 簽署了一項協議——你們中的一些人可能熟悉 UCB，它是該領域最大的製藥公司之一——以達成另一項合作安排。並且還有更多內容即將推出。

We've got a pipeline of folks that we're talking to and working on these types of collaborations with, along with extending Rapport's arrangement. And so, for the part of your question where you talk about the future state, we see the future state as being now in expanding those partnerships and see this as something that we think can -- has potential for us going forward as well.

我們已經與一批人員進行了交談，並正在與他們進行此類合作，同時擴大 Rapport 的安排。因此，對於您問題中談到的未來狀態的部分，我們認為未來狀態是現在擴大這些夥伴關係，並且我們認為這對我們未來的發展也有潛力。

And I think from a materiality standpoint, I'll take that one. Clearly, it's not overly material at this point. If it gets to the point where we need to start breaking it out as a segment, we'll cross that path, and we'll probably have big smiles on our face if we get there. But what I would say is that it's good revenue. It's got good margins associated with it because we essentially have the people here that are already here.

我認為從實質的角度來看，我會選擇這個。顯然，目前情況還不是太重要。如果到了需要將其細分為部分的地步，我們就會跨過這條路，如果我們到達那裡，我們可能會露出燦爛的笑容。但我想說的是，這是一筆不錯的收入。它具有良好的利潤率，因為我們基本上擁有已經在這裡的人。

And so, as I said in my prepared comments and one of the reasons why I came here, and I think the exciting part here is the data, 22 million records, continuing to build. As we can become the demonstrated leaders in this field, I think we're going to see a lot more people approach us to try to access that data to help guide them in their decision-making and ultimately to help patients.

因此，正如我在準備好的評論中所說的那樣，我來這裡的原因之一，我認為這裡令人興奮的部分是數據，2200 萬條記錄，還在不斷積累。由於我們能夠成為該領域的領先者，我認為我們將看到更多的人與我們接洽，試圖獲取這些數據以幫助他們做出決策，並最終幫助患者。

Sounds great. Thanks for taking our questions.

聽起來很棒。感謝您回答我們的問題。

Yi Chen, HC Wainwright.

陳毅，HC Wainwright。

Thank you for taking my question. My first question is, now that you plan to target the entire NAUTILUS study population in the submission, how likely is it do you think the FDA will ask you to conduct an additional clinical trial?

感謝您回答我的問題。我的第一個問題是，既然您計劃在提交的申請中針對整個 NAUTILUS 研究人群，您認為 FDA 要求您進行額外臨床試驗的可能性有多大？

It's a great question. We believe that the data associated with the NAUTILUS trial is compelling standing on its own. And we think that we've got, from a totality of evidence perspective, more than enough information to have a substantial discussion and for a benefit-risk decision to be made.

這是一個很好的問題。我們相信，NAUTILUS 試驗的相關數據本身就具有令人信服的說服力。我們認為，從整體證據的角度來看，我們已經獲得了足夠的資訊來進行實質的討論並做出效益風險決策。

So we don't believe that an additional trial is necessary, and we think that the data is compelling and both statistically significant as well as clinically very meaningful coming from the trial here. And those are the discussions that we plan on having with the agency here shortly.

因此，我們認為沒有必要進行額外的試驗，我們認為本次試驗的數據令人信服，具有統計意義和臨床意義。這些就是我們計劃近期與該機構進行的討論。

Got it. And my follow-up question is, how significant is the pediatric market opportunity for you? And can you provide an estimated time line for submission and potential approval?

知道了。我的後續問題是，兒科市場機會對您來說有多重要？您能否提供提交和可能批准的預計時間表？

It's a great question. We think the pediatric market has significant opportunity associated with it. And there's a couple of dynamics there. One, the segment is large. And two, we think the adoption dynamics are very positive.

這是一個很好的問題。我們認為兒科市場具有巨大的機會。這裡面存在著一些動態。一是細分領域較大。其次，我們認為採用動態非常積極。

I've spoken about previously that everybody has a sense of urgency when they're not feeling well. The sense of urgency is entirely different when a child isn't feeling well, and we see that in epilepsy therapy, too. So we think there's a strong level of interest among patients and patient support networks around those patients, their families.

我之前說過，每個人在感覺不舒服的時候都會有一種緊迫感。當孩子感到不舒服時，緊迫感是完全不同的，我們在癲癇治療中也看到了這種情況。因此，我們認為患者以及患者及其家人的支持網絡對此有著濃厚的興趣。

We know there's a strong level of interest from pediatric epileptologists and pediatric functional neurosurgeons. And frankly, we have a real commitment to the pediatric segment when we think about the mission of this business to help patients who suffer from seizures.

我們知道兒科癲癇專家和兒科功能神經外科醫生對此有濃厚的興趣。坦白說，當我們想到這項業務的使命是幫助患有癲癇的患者時，我們對兒科領域有著真正的承諾。

Pediatric patients should have access to RNS therapy. When you think about untreated seizures, those are bad, and they're bad for people's brain function and they're even worse when you're talking about developmental brain function. And so, we feel very strongly and are very committed to this for missional reasons.

兒科患者應該能夠接受 RNS 治療。未經治療的癲癇發作會帶來嚴重後果，對人們的大腦功能有害，而對於發育性大腦功能來說，後果就更糟了。因此，我們對此深有感觸，並為了使命而全力以赴。

And additionally, there's a significant unmet need with a significant number of patients. Pediatric -- or epilepsy, in many cases, is an early onset disorder. And again, it's during a developmental phase where neuromodulation can make a particularly big impact. So we're very committed to the pediatric segment.

此外，大量患者還有未滿足的重大需求。在許多情況下，兒童癲癇是一種早發性疾病。再次強調，在發育階段，神經調節可以產生特別大的影響。所以我們非常致力於兒科領域。

Can you provide a timeline?

能提供一下時間表嗎？

Yeah. So I'm sorry, thank you. Thanks for reminding me of that. Yeah. So what we said previously is, our focus is on a submission in the second half of '25. We're making progress from a regulatory and project perspective. And if there's any updates, we'll give them to you, but that's what we've talked about.

是的。所以我很抱歉，謝謝。謝謝你提醒我這一點。是的。所以我們之前說過，我們的重點是 25 年下半年的投稿。從監管和專案角度來看，我們正在取得進展。如果有任何更新，我們會告知您，但這就是我們所談論的。

Got it. Thank you.

知道了。謝謝。

Thank you. Ladies and gentlemen, as there are no further questions, I would now like to hand the conference over to Joel Becker for closing comments.

謝謝。女士們、先生們，由於沒有其他問題，我現在想將會議交給喬爾貝克爾 (Joel Becker) 進行總結發言。

Thanks, everybody. We really appreciate it. We had another strong quarter here, an increased revenue guide, increased gross margin guide, operating discipline, good progress on a number of fronts, including key initiatives in the leadership team and debt refinance and solid reimbursement outcomes, and there's just a lot of good momentum going here.

謝謝大家。我們非常感激。我們又度過了一個強勁的季度，收入指南增加了，毛利率指南增加了，經營紀律嚴明，在多個方面取得了良好進展，包括領導團隊的關鍵舉措和債務再融資以及穩健的償還結果，而且這裡有很多良好的勢頭。

I appreciate everybody's ongoing interest and all of your engagement with NeuroPace. As I mentioned in my earlier comments a couple of different times, I've never felt more confident in our plans and our position and in the team. And we're focused on executing here to the benefit of patients, clinicians and shareholders. Thanks again.

我感謝大家對 NeuroPace 的持續關注和參與。正如我之前多次在評論中提到的那樣，我從未對我們的計劃、我們的立場和團隊感到如此有信心。我們致力於為病患、臨床醫師和股東謀福利。再次感謝。

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的電話會議到此結束。現在您可以斷開線路。感謝您的參與。