Neuropace Inc (NPCE) 2023 Q1 法說會逐字稿

Good afternoon, and welcome to NeuroPace's first quarter earnings conference call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes.

下午好，歡迎參加 NeuroPace 第一季度收益電話會議。 （操作員說明）謹此提醒，此通話正在錄音以供重播之用。

I would now like to turn the call over to Trip Taylor from Gilmartin Group for a few introductory comments.

我現在想將電話轉給吉爾馬丁集團的 Trip Taylor，請其發表一些介紹性意見。

Thank you, operator. Good afternoon, and thank you for participating in today's call. Joining me from NeuroPace are Mike Favet, CEO; and Rebecca Kuhn, CFO. Earlier today, NeuroPace released financial results for the first quarter ended March 31, 2023. A copy of the press release is available on the company's website.

謝謝你，接線員。下午好，感謝您參加今天的電話會議。與我一起來自 NeuroPace 的還有首席執行官 Mike Favet；和首席財務官麗貝卡·庫恩。今天早些時候，NeuroPace 發布了截至 2023 年 3 月 31 日的第一季度財務業績。該新聞稿的副本可在該公司網站上獲取。

Before we begin, I would like to remind you that management will make statements during this call 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，管理層將在本次電話會議期間發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據 1995 年《私人證券訴訟改革法案》的安全港條款制定的. 本次電話會議期間做出的任何與對未來事件、結果或業績的預期或預測相關的陳述均為前瞻性陳述。

All forward-looking statements, including those around NeuroPace's business opportunities, market conditions, clinical trials and those relating to our operating trends and future financial performance, the impact of COVID-19 on our business and prospects for recovery, expense management, market opportunity, revenue outlook and commercial expansion 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，包括有關 NeuroPace 的商業機會、市場狀況、臨床試驗的陳述以及與我們的運營趨勢和未來財務業績、COVID-19 對我們業務的影響以及復蘇前景、費用管理、市場機會有關的陳述，收入前景和商業擴張基於當前的估計和各種假設。這些陳述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陳述所暗示的結果或事件存在重大差異。因此，您不應過分依賴這些陳述。

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 annual report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 2, 2023, and our quarterly report on Form 10-Q for the quarter ended March 31, 2023, to be filed with the SEC as well as any reports that we may file with the SEC in the future.

有關與我們業務相關的風險和不確定性的更多詳細說明，請參閱我們向 SEC 提交的公開文件中的風險因素部分，包括我們向 SEC 提交的截至 2022 年 12 月 31 日的 10-K 表格年度報告。 SEC 於 2023 年 3 月 2 日提交的報告，以及我們將向 SEC 提交的截至 2023 年 3 月 31 日的季度的 10-Q 表格季度報告，以及我們將來可能向 SEC 提交的任何報告。

This conference call contains time-sensitive information, which we believe is accurate only as of this live broadcast on May 4, 2023. NeuroPace disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.

本次電話會議包含時間敏感的信息，我們認為這些信息僅截至 2023 年 5 月 4 日的本次直播準確。 NeuroPace 不承擔任何更新或修改任何財務預測或前瞻性的意圖或義務，除非法律要求。陳述，無論是由於新信息、未來事件還是其他原因。

And with that, I will now turn the call over to Mike.

現在，我將把電話轉給邁克。

Thanks, Trip. Good afternoon, everyone, and thank you for joining us today. Today, I will highlight our first quarter performance and provide an update on our key business priorities for the year. I will then turn the call over to Rebecca to detail the financial results before we open the call to questions.

謝謝，特里普。大家下午好，感謝您今天加入我們。今天，我將重點介紹我們第一季度的業績，並介紹我們今年主要業務重點的最新情況。然後，在我們開始提問之前，我會將電話轉給麗貝卡，詳細說明財務業績。

To begin, our strong commercial and operational execution led to record revenue in the first quarter. Total revenue was $14.5 million, representing growth of 27% compared to the prior year period and 13% compared to the fourth quarter of 2022. The strong performance was driven by increased utilization of the RNS system within comprehensive epilepsy centers or CECs and contributions from our DIXI Medical distribution partnership, which began in the fourth quarter of 2022.

首先，我們強大的商業和運營執行力導致第一季度收入創紀錄。總收入為 1,450 萬美元，較去年同期增長 27%，較 2022 年第四季度增長 13%。這一強勁業績的推動因素是綜合癲癇中心或 CEC 內 RNS 系統利用率的增加以及我們的貢獻DIXI Medical 分銷合作夥伴關係於 2022 年第四季度開始。

As expected, replacement implant revenue continued to decline compared to prior quarters and now represents less than 10% of total revenue. With our continued focus on expense management, we increased revenue in the first quarter without a corresponding increase in expense compared to the fourth quarter of 2022.

正如預期的那樣，替換種植體收入與前幾個季度相比繼續下降，目前佔總收入的比例不到 10%。由於我們持續關注費用管理，與 2022 年第四季度相比，我們第一季度的收入有所增加，但費用沒有相應增加。

Based on the strong underlying fundamentals of our business, we now expect full year 2023 total revenue of $52 million to $54 million, up from our original expectation of $50 million to $52 million. Growth in 2023 will continue to be driven primarily by increasing utilization of the RNS system within CECs, coupled with our first full year selling DIXI Medical products.

基於我們業務強勁的基本面，我們現在預計 2023 年全年總收入為 5200 萬美元至 5400 萬美元，高於我們最初預期的 5000 萬美元至 5200 萬美元。 2023 年的增長將繼續主要受到 CEC 內 RNS 系統利用率的提高以及我們第一個全年銷售 DIXI Medical 產品的推動。

Overall, I am pleased with the progress we have made with our strategy, and I'm happy to see epileptologists recognizing the differentiated features and benefits of our RNS system. Our customers reported that epilepsy-monitoring unit, or EMU, patient volumes have remained stable over the last year. While we continue to believe that patient volumes are not all the way back to prepandemic levels, they continue to show signs of improvement.

總的來說，我對我們的戰略所取得的進展感到高興，我很高興看到癲癇學家認識到我們 RNS 系統的差異化功能和優勢。我們的客戶報告說，癲癇監測單位（EMU）的患者數量在去年保持穩定。雖然我們仍然相信患者數量並未完全恢復到大流行前的水平，但它們繼續顯示出改善的跡象。

Now I will discuss our commercial objectives in more detail. To increase utilization of the RNS system and support our initial implant revenue growth in 2023, our strategy concentrates on 3 objectives: one, expanding patient selection; two, managing the patient pipeline; and three, driving adoption of the RNS system with new prescribers and additional implanting centers.

現在我將更詳細地討論我們的商業目標。為了提高 RNS 系統的利用率並支持我們在 2023 年的初始種植體收入增長，我們的戰略集中於 3 個目標：一是擴大患者選擇；二、管理患者管道；第三，通過新的處方醫生和更多的植入中心推動 RNS 系統的採用。

Our first quarter 2023 results demonstrate that awareness of the clinical benefits of the RNS system is growing as we continue to develop a strong presence amongst epileptologists and neurosurgeon customers. We remain focused on highlighting the need to close the treatment gap so that more of their patients can realize the life-changing benefits provided by our products. Specifically, our team continues to educate physicians on the benefits of the RNS system and the importance of providing advanced treatment to their drug-resistant epilepsy patients.

我們 2023 年第一季度的結果表明，隨著我們在癲癇科醫生和神經外科醫生客戶中不斷發展強大的影響力，人們對 RNS 系統臨床益處的認識正在不斷增強。我們仍然專注於強調縮小治療差距的必要性，以便更多的患者能夠實現我們的產品所提供的改變生活的益處。具體來說，我們的團隊繼續向醫生宣傳 RNS 系統的好處以及為耐藥性癲癇患者提供先進治療的重要性。

As we share and discuss the clinical evidence that supports expanding patient selection criteria to the full scope of RNS systems indication, we are seeing improvements in utilization. We are working to actively manage the patient pipeline within the CECs. We are identifying and educating potential RNS patients at an earlier stage in their treatment journey, which we believe is crucial to increasing RNS system adoption. Our patient education and marketing programs enable us to convert more patient leads to RNS system implants.

當我們分享和討論支持將患者選擇標準擴展到 RNS 系統適應症的全部範圍的臨床證據時，我們看到了利用率的提高。我們正在努力積極管理 CEC 內的患者管道。我們正在治療過程的早期階段識別和教育潛在的 RNS 患者，我們認為這對於提高 RNS 系統的採用率至關重要。我們的患者教育和營銷計劃使我們能夠將更多患者轉為 RNS 系統植入物。

Patient leads are being identified through our field team working with the CECs and through direct-to-consumer campaigns. We leverage NeuroPace Nurse Navigators to guide the patients in our pipeline through the diagnostic process. Additionally, our team, along with the network of RNS patient ambassadors provide in-depth patient education on the benefits of our RNS system.

我們的現場團隊與 CEC 合作並通過直接面向消費者的活動來確定患者線索。我們利用 NeuroPace 護士導航器來指導我們管道中的患者完成診斷過程。此外，我們的團隊以及 RNS 患者大使網絡就我們的 RNS 系統的優勢提供深入的患者教育。

We are very pleased with the results of the first 2 quarters, distributing the DIXI Medical stereo EEG products in the United States. This product line is driving additional revenue through our commercial team and has enabled us to identify and interact with potential RNS candidates earlier in their patient journey. As a reminder, stereo EEG electrodes are used to determine where epileptic seizures originate. Most RNS patients and most surgical resection and ablation patients in the United States are being localized with stereo EEG prior to therapeutic intervention.

我們對前兩個季度的業績非常滿意，在美國分銷 DIXI Medical 立體腦電圖產品。該產品線通過我們的商業團隊帶來了額外的收入，並使我們能夠在患者旅程的早期識別潛在的 RNS 候選者並與之互動。提醒一下，立體腦電圖電極用於確定癲癇發作的起源。在美國，大多數 RNS 患者以及大多數手術切除和消融患者在治療干預之前都會使用立體腦電圖進行定位。

Over time, we believe that we can grow the revenue from DIXI Medical products by leveraging our large epilepsy-focused commercial team to convert competitive accounts and leverage this product line to accelerate adoption of our RNS system. We are making good progress in our efforts to increase the number of implanting centers and prescribing physicians. With our expanded field team, we are calling on additional CECs and increasing the number of prescribing physicians. Improving patient access to care by increasing the number of providers utilizing the RNS system is an important part of our effort to close the treatment gap. We are doing this by expanding professional education programs and through the work of our field team.

隨著時間的推移，我們相信，通過利用我們專注於癲癇的大型商業團隊來轉換競爭性客戶並利用該產品線加速我們的 RNS 系統的採用，我們可以增加 DIXI Medical 產品的收入。我們在增加植入中心和處方醫生數量方面取得了良好進展。隨著我們擴大的現場團隊，我們正在呼籲增加 CEC 並增加處方醫生的數量。通過增加使用 RNS 系統的提供者數量來改善患者獲得護理的機會是我們縮小治療差距努力的重要組成部分。我們正在通過擴大專業教育計劃和我們的現場團隊的工作來做到這一點。

Moving to our clinical trial updates. We continue to make strong progress on our top clinical priority the expansion into generalized epilepsy. As a reminder, this represents a meaningful market expansion opportunity is approximately 40% of drug-resistant epilepsy patients have generalized epilepsy. Diagnosis of these patients is simpler and faster than for focal epilepsy because it does not require advanced diagnostics, and there are a few treatment options because resection and ablation are not applicable and no neuromodulation therapy is approved for this patient group.

轉向我們的臨床試驗更新。我們在臨床首要任務——擴展到全身性癲癇方面繼續取得重大進展。提醒一下，這代表了一個有意義的市場擴張機會，因為大約 40% 的耐藥性癲癇患者患有全身性癲癇。這些患者的診斷比局灶性癲癇更簡單、更快，因為它不需要先進的診斷，並且有一些治療選擇，因為切除和消融不適用，並且沒有神經調節治療被批准用於該患者組。

Enrollment of the approximately 100 patients in the NAUTILUS study is on track to be completed in the first quarter of 2024. As a reminder, the primary endpoint is evaluating the safety and efficacy of the device at a 1-year follow-up evaluation after implantation. We intend for the results from this study to support a PMA supplement to expand the RNS system indication to include the treatment of primary generalized epilepsy. Additionally, our NIH-funded feasibility study for patients with Lennox-Gastaut syndrome, a type of symptomatic generalized epilepsy continues to progress as planned. We look forward to potentially providing an optimal solution for an unmet need amongst this patient population.

NAUTILUS 研究的約 100 名患者的招募預計將於 2024 年第一季度完成。提醒一下，主要終點是在植入後一年的隨訪評估中評估該設備的安全性和有效性。我們打算利用這項研究的結果來支持 PMA 補充劑，以擴大 RNS 系統的適應症，包括原發性全身性癲癇的治療。此外，我們由 NIH 資助的針對 Lennox-Gastaut 綜合徵（一種有症狀的全身性癲癇症）患者的可行性研究繼續按計劃取得進展。我們期待為該患者群體中未滿足的需求提供最佳解決方案。

To summarize, we are off to a great start for the year, executing across the entire business. Increasing utilization of the RNS system at CECs drove growth in initial implant revenue, and our team is gaining traction with the distribution of the DIXI Medical Stereo EEG products. We are invigorated by the increasing utilization trajectory and remain focused on ensuring patients receive the care that they need.

總而言之，我們今年有一個良好的開端，整個業務都在執行。 CEC 中 RNS 系統利用率的提高推動了初始植入收入的增長，我們的團隊通過 DIXI Medical Stereo EEG 產品的分銷獲得了關注。我們對不斷增加的使用軌跡感到振奮，並繼續致力於確保患者獲得他們所需的護理。

Our NAUTILUS pivotal study for primary generalized epilepsy and the NIH study for Lennox-Gastaut syndrome are progressing as planned. We successfully accomplished all of this while continuing to improve our cash burn trajectory. We believe our recent achievements keep us well positioned for a successful 2023.

我們針對原發性全身性癲癇的 NAUTILUS 關鍵研究和 NIH 針對 Lennox-Gastaut 綜合徵的研究正在按計劃進行。我們成功地完成了所有這一切，同時繼續改善我們的現金消耗軌跡。我們相信，我們最近取得的成就使我們能夠在 2023 年取得成功。

With that, I will now turn the call over to Rebecca to review our first quarter financial results.

現在，我將把電話轉給麗貝卡，以審查我們第一季度的財務業績。

Thanks, Mike. NeuroPace's revenue for the first quarter of 2023 was $14.5 million, representing growth of 27% compared to $11.4 million for the first quarter of 2022 and 13% sequentially compared to $12.8 million in the fourth quarter of 2022. This strong performance was primarily driven by increased utilization of our RNS system and by contributions from our DIXI Medical distribution partnership.

謝謝，邁克。 NeuroPace 2023 年第一季度的收入為 1450 萬美元，與 2022 年第一季度的 1140 萬美元相比增長了 27%，與 2022 年第四季度的 1280 萬美元相比增長了 13%。這種強勁的業績主要是由於增長利用我們的 RNS 系統以及我們的 DIXI Medical 分銷合作夥伴的貢獻。

We experienced higher replacements than anticipated in the first quarter, but as expected, replacement implant revenue continued to decline compared to prior quarters and now represents less than 10% of total revenue. Gross margin for the first quarter of 2023 was 72% compared to 73% in the first quarter of 2022 and 69% in the fourth quarter of 2022. The decline in gross margin relative to the prior year period was primarily due to a change in product mix with the inclusion of DIXI Medical products, which have a lower gross margin than our core RNS products.

第一季度我們的替換種植體數量高於預期，但正如預期的那樣，替換種植體收入與前幾個季度相比繼續下降，目前佔總收入的比例不到 10%。 2023年第一季度的毛利率為72%，而2022年第一季度的毛利率為73%，2022年第四季度的毛利率為69%。毛利率較上年同期下降的主要原因是產品的變化與 DIXI Medical 產品相結合，該產品的毛利率低於我們的核心 RNS 產品。

During this first quarter of 2023, we also had higher-than-anticipated sales attributed to DIXI Medical. Over time, we expect gross margins will generally increase as volumes increase and fixed overhead is allocated over more units. Total operating expenses in the first quarter of 2023 were $18.7 million compared with $18 million in the same period of the prior year.

2023 年第一季度，DIXI Medical 的銷售額也高於預期。隨著時間的推移，我們預計毛利率通常會隨著銷量的增加而增加，並且固定管理費用會分配給更多的單位。 2023 年第一季度的總運營費用為 1,870 萬美元，而上年同期為 1,800 萬美元。

In the first quarter of 2023, operating expenses as a percentage of revenue were lower for both R&D and SG&A. We plan to continue to focus on initiatives to optimize operating expenses through 2023. R&D expense in the first quarter of 2023 was $5.3 million compared with $5.6 million in the same period of 2022. The decrease in R&D expense was primarily driven by a decrease in personnel-related expenses and clinical study expenses.

2023 年第一季度，研發和銷售、管理及行政費用 (SG&A) 的運營費用佔收入的百分比均較低。我們計劃到 2023 年繼續專注於優化運營費用的舉措。2023 年第一季度的研發費用為 530 萬美元，而 2022 年同期為 560 萬美元。研發費用的減少主要是由於人員減少-相關費用和臨床研究費用。

SG&A expense in the first quarter of 2023 was $13.4 million compared with $12.4 million in the prior year period. The increase in SG&A was primarily driven by personnel-related expenses and expenses associated with distributing DIXI medical products, partially offset by reduced expenses for general and administrative outside services.

2023 年第一季度的 SG&A 費用為 1,340 萬美元，而上年同期為 1,240 萬美元。 SG&A 的增長主要是由人事相關費用以及與分銷 DIXI 醫療產品相關的費用推動的，但部分被一般和行政外部服務費用的減少所抵消。

Loss from operations was $8.3 million in the first quarter of 2023 compared with $9.8 million in the prior year period. We recorded $2 million in interest expense in the first quarter compared to $1.8 million in the prior year period. Net loss was $10.4 million for the first quarter of 2023 compared with $11.5 million in the first quarter of 2022. Our cash and short-term investments balance as of March 31, 2023, was $67.6 million. Our long-term borrowings totaled $53.9 million as of March 31, 2023, with the full principal due on September 30, 2025.

2023 年第一季度運營虧損為 830 萬美元，而上年同期為 980 萬美元。我們第一季度的利息支出為 200 萬美元，而去年同期為 180 萬美元。 2023 年第一季度的淨虧損為 1040 萬美元，而 2022 年第一季度的淨虧損為 1150 萬美元。截至 2023 年 3 月 31 日，我們的現金和短期投資餘額為 6760 萬美元。截至 2023 年 3 月 31 日，我們的長期借款總額為 5,390 萬美元，本金將於 2025 年 9 月 30 日全額到期。

Now turning to our outlook for the remainder of 2023. We are increasing our revenue guidance and now expect total revenue for 2023 to range between $52 million and $54 million, up from $50 million to $52 million. We expect that revenue growth will be supported mainly by increases in initial implants and revenue from the sale of DIXI Medical Products.

現在轉向我們對 2023 年剩餘時間的展望。我們正在提高收入指導，目前預計 2023 年的總收入將在 5,200 萬美元至 5,400 萬美元之間，從 5,000 萬美元至 5,200 萬美元上調。我們預計收入增長將主要受到初始植入物增加和 DIXI 醫療產品銷售收入的支持。

We continue to expect that we will complete the replacement of substantially all of the prior generation RNS devices by the end of 2023. With more replacement implants than anticipated in the first quarter, replacement revenue is expected to sequentially decline at a rate slightly faster than we anticipated earlier in the year. Replacement implant revenue will become a growth driver when the newer longer-lasting devices introduced in 2018 began to reach the end of their battery life.

我們仍然預計，到 2023 年底，我們將完成對幾乎所有上一代 RNS 設備的更換。由於第一季度的更換植入物數量超出預期，預計更換收入將以略快於我們的速度連續下降今年早些時候預計。當 2018 年推出的更新、耐用的設備開始達到電池壽命時，替換植入物收入將成為增長動力。

We continue to expect our gross margin for 2023 will be between 69% and 71%. Our quarterly gross margins may experience small variability due to fluctuations in the proportion of DIXI medical revenue to overall revenue and other factors. We continue to expect operating expenses for 2023 to range between $75 million and $77 million, including $11 million to $12 million in noncash expenses.

我們仍然預計 2023 年的毛利率將在 69% 至 71% 之間。由於DIXI醫療收入佔整體收入比例的波動和其他因素，我們的季度毛利率可能會出現小幅波動。我們仍然預計 2023 年的運營支出將在 7500 萬美元至 7700 萬美元之間，其中包括 1100 萬美元至 1200 萬美元的非現金支出。

Our cash burn in the first quarter of 2023 was $9.8 million, a substantial reduction from our cash burn of $12.4 million in the first quarter of 2022. Our cash burn is typically highest in the first quarter of the year, primarily due to the timing of compensation-related expenses. First quarter spending included approximately $3 million of expenses primarily compensation related that are unique to the first quarter.

我們 2023 年第一季度的現金消耗為 980 萬美元，比 2022 年第一季度 1240 萬美元的現金消耗大幅減少。我們的現金消耗通常在今年第一季度最高，主要是由於與補償相關的費用。第一季度支出包括約 300 萬美元的支出，主要與第一季度特有的薪酬相關。

This concludes our prepared remarks. I would now like to turn the call over to the operator who will open the call for questions.

我們準備好的發言到此結束。我現在想將電話轉給接線員，接線員將打開電話詢問問題。

(Operator Instructions) Our first question comes from Robbie Marcus from JPMorgan.

（操作員說明）我們的第一個問題來自摩根大通的 Robbie Marcus。

This is Rohin on for Robbie. I guess I had a couple. The first one is focused on guidance. So guidance is coming up by about $2 million, which is essentially to be in the quarter. So this implies a step down in revenues for the balance of the year. Would you be able to comment on just how you're thinking about quarterly revenue contribution moving forward and the cadence, especially just given the commentary around the patient funnel kind of stabilizing? And I'm assuming getting better as the year progresses?

這是羅辛為羅比代言的節目。我想我有一對。一是注重引導。因此，指導意見將上漲約 200 萬美元，這基本上是在本季度發生的。因此，這意味著今年剩餘時間的收入將下降。您能否評論一下您如何看待季度收入貢獻的進展和節奏，特別是考慮到圍繞患者漏斗的評論趨於穩定？我假設隨著時間的推移會變得更好？

Great. A couple of comments first about the quarter and then getting into your question about guidance. So we're really happy with the performance overall strength across all parts of the business. For the forecast, as we go forward, we continue to expect that revenue from initial implants will grow through the course of the year. We've been able to make great progress here in the first quarter, continuing of some success that we were able to build off of in the second half of 2022. So that general trend of increasing plan additional implant revenue as we move through the year.

偉大的。首先是關於本季度的一些評論，然後是關於指導的問題。因此，我們對業務各個部門的整體表現感到非常滿意。對於預測，隨著我們的前進，我們繼續預計初始植入的收入將在全年中增長。我們在第一季度取得了巨大進展，延續了我們在 2022 年下半年取得的一些成功。因此，隨著我們全年的發展，增加計劃額外植入收入的總體趨勢。

For DIXI Medical, we had a really strong quarter in Q1. It's still a relatively new business for us, and we're -- I'm still projecting as we go forward that we'll be building off of the base that we talked about in Q4 -- the revenue from Q4 with marginal increases -- incremental increases off of that base. We did better than that in the first quarter, but we're not including in any guidance on changes to that. So as we get more time working with the DIXI Medical product, we'll have better confidence around that. The guidance that we're providing is really based on where we started with that business in the first quarter of last year.

對於 DIXI Medical 來說，我們在第一季度的季度業績非常強勁。對於我們來說，這仍然是一項相對較新的業務，而且我們 - 我仍然預測，隨著我們的前進，我們將在我們在第四季度討論的基礎上進行建設 - 第四季度的收入邊際增長 - - 在此基礎上增量增加。我們的表現比第一季度要好，但我們沒有將其納入任何有關變化的指導中。因此，當我們有更多時間使用 DIXI Medical 產品時，我們就會對此更有信心。我們提供的指導實際上是基於去年第一季度我們開始開展該業務的情況。

And then specifically about replacement implant revenue. We had a strong quarter in the first quarter with more implants than we had anticipated more replacement it went than we had anticipated. We generated about $1.2 million of revenue in the first quarter from replacement and plans. That is from earlier device replacements in the year than what we had thought when we started off.

然後特別是關於更換植入物的收入。我們在第一季度表現強勁，植入物數量超出了我們的預期，更換數量也超出了我們的預期。第一季度我們通過更換和計劃創造了約 120 萬美元的收入。這是因為今年的設備更換比我們開始時的預期要早。

And the result of that is while the total number of replacement devices and the implant revenue that we expect to generate from that for the year will be the same as before because there's a higher proportion of that in the first quarter. That will result in less revenue in the second through the fourth quarters because of the total volume of those older devices that are still needing to be replaced.

其結果是，我們預計今年的替換設備總數和植入收入將與以前相同，因為第一季度的比例更高。由於仍需要更換的舊設備總量，這將導致第二至第四季度的收入減少。

So overall, again, strength across all aspects of the business, continuing to expect growth in initial implant revenue as we move through the quarter and then not banking into our guidance, any changes in the general trajectory of the DIXI Medical product. While that came in higher than we expected in the first quarter, really happy with that. But it's not -- we're not baking that into the guidance that we're providing.

因此，總體而言，業務各個方面的實力都很強，隨著我們整個季度的發展，我們將繼續預期初始植入物收入的增長，然後不會將 DIXI Medical 產品總體軌蹟的任何變化納入我們的指導中。雖然這一數字高於我們第一季度的預期，但我們對此感到非常滿意。但事實並非如此——我們沒有將其納入我們提供的指導中。

Got it. That's really helpful. The other question I had was just around the generalized epilepsy indication. It seems like you're making really good progress towards NAUTILUS. And I guess it would just be helpful if you can remind us what the market opportunity is here down the line and when we could potentially see kind of a contribution pending approval.

知道了。這真的很有幫助。我的另一個問題是關於全身性癲癇的適應症。看來您在 NAUTILUS 方面取得了很大的進展。我想，如果您能提醒我們未來的市場機會是什麼，以及我們何時可能看到某種待批准的捐款，那將會很有幫助。

Yes. Thank you for that question as well. I'm really, really encouraged by, 1, the start that we've had to the NAUTILUS study, getting that study up and running and the importance that I believe that, that's going to have for our business over time.

是的。也謝謝你提出這個問題。我真的非常非常受到鼓舞，1，我們開始進行 NAUTILUS 研究，讓這項研究啟動並運行，我相信隨著時間的推移，這將對我們的業務產生重要影響。

As a reminder, generalized epilepsy represents about 40% of the patients that have drug-resistant epilepsy. So it's a very large market opportunity. And compared to focal epilepsy, there are even fewer treatment options for these patients that have generalized epilepsy, resective procedures and ablative procedures, which are the most commonly done interventions for focal epilepsy are not applicable for generalized epilepsy, and there are currently no neuromodulation therapies that are indicated for generalized epilepsy. So very much an undertreated patient populations. The reason we were able to get the breakthrough device designation from the FDA for this group.

需要提醒的是，全身性癲癇約佔耐藥性癲癇患者的 40%。所以這是一個非常大的市場機會。與局灶性癲癇相比，全身性癲癇患者的治療選擇更少，切除手術和消融手術是局灶性癲癇最常用的干預措施，但不適用於全身性癲癇，目前還沒有神經調節療法適用於全身性癲癇。因此，患者群體中治療不足。這就是我們能夠從 FDA 獲得針對該組的突破性設備指定的原因。

Additionally, the diagnostic process to identify patients that have generalized epilepsy is easier and faster than for focal epilepsy. So large patient population, very much an unmet need with a lack of treatment options for these DRE patients and an opportunity to get more patients treated more quickly with a simpler diagnostic, simpler and faster diagnostic process.

此外，識別全身性癲癇患者的診斷過程比局灶性癲癇患者更容易、更快捷。如此龐大的患者群體，很大程度上是一個未得到滿足的需求，因為這些 DRE 患者缺乏治療選擇，也沒有機會通過更簡單的診斷、更簡單和更快的診斷過程更快地治療更多患者。

In terms of timing, we had announced last quarter that we expect to have enrollment completed in that trial in the first quarter of next year. And that continues to be the expectation. We announced a couple of months ago that we had all of the sites, the 25 sites on board and starting to enroll patients, and there's a tremendous amount of enthusiasm from the investigator group. And so we're off to a good start continuing to believe that we're tracking well to have that completion.

就時間安排而言，我們在上季度宣布，預計將於明年第一季度完成該試驗的註冊。這仍然是人們的期望。幾個月前，我們宣布我們擁有所有站點，即 25 個站點，並開始招募患者，研究小組對此表現出極大的熱情。因此，我們有了一個良好的開端，繼續相信我們正在順利完成這一任務。

As a reminder, the study itself has a 1-year follow-up for the primary endpoint after implantation of the device. And so building off of that first quarter of 2024 completion of enrollment, the follow-up period and then a PMA supplement on the other side of that. So you can kind of figure out the time line associated with it that continue to be tracking well to that timeline.

提醒一下，該研究本身對植入設備後的主要終點進行了 1 年的隨訪。因此，以 2024 年第一季度完成註冊、後續期以及另一邊的 PMA 補充為基礎。因此，您可以找出與之相關的時間線，並繼續很好地跟踪該時間線。

Our next question comes from Frank Takkinen from Lake Street Capital Markets.

我們的下一個問題來自 Lake Street Capital Markets 的 Frank Takkinen。

Congrats on the progress in the quarter. I wanted to dive a little deeper into the per center trends. Could you maybe take us into what really drove the growth in the quarter? And I'm kind of thinking of 2 levers. Was it new centers coming on board and starting to treat patients or was it as existing centers starting to treat more patients and improving their utilization run rate?

祝賀本季度取得的進展。我想更深入地了解每個中心的趨勢。您能否帶我們了解一下真正推動本季度增長的因素？我想有兩個槓桿。是新的中心加入並開始治療患者，還是現有的中心開始治療更多的患者並提高其利用率？

Frank, the growth we saw in the first quarter was primarily driven from utilization, more patients being treated within the comprehensive epilepsy centers that treat -- than they treated in 2022 primarily coming from that. We did get off to a faster start in the year with more sensors and prescribers. So that was a contribution as well. So there was contributions from both utilization increase and sensor increase. But as we expected, the bulk of that coming from increased utilization.

弗蘭克，我們在第一季度看到的增長主要來自利用率，與 2022 年相比，在綜合性癲癇中心接受治療的患者數量主要來自於此。我們確實在這一年有了更快的開局，擁有更多的傳感器和處方者。所以這也是一種貢獻。因此，利用率的增加和傳感器的增加都有貢獻。但正如我們預期的那樣，其中大部分來自利用率的提高。

Very good. Good color. And then, on DIXI, I know one of the primary attractions to the distribution agreement was getting color into the patient funnel. And I think you referenced it at a high level in the prepared remarks. But could you maybe talk to how that is playing out versus your expectations and how your sales force is maybe leveraging some of that information to convert patients to RNS versus competitive technologies?

非常好。顏色好。然後，在 DIXI 上，我知道分銷協議的主要吸引力之一是為患者渠道注入色彩。我認為您在準備好的發言中高度引用了這一點。但是您能否談談這與您的預期相比效果如何，以及您的銷售人員如何利用其中一些信息將患者轉變為 RNS 而不是競爭技術？

2 quarter -- we're 2 quarters now into the distribution agreement. I'm really pleased with how that product fits into what we're selling within our team. We've been able to have good success using the team that we've got to establish large epilepsy-focused field team calling on these epilepsy centers. We've had some success with account conversions to be able to grow that business. But as you mentioned, one of the key strategic drivers for us in doing this was to have better visibility earlier to patients working through the diagnostic process that lead to an RNS implant.

第二季度——我們已經簽訂分銷協議了兩個季度。我對該產品與我們團隊銷售的產品的契合度感到非常滿意。我們已經能夠利用我們的團隊取得良好的成功，我們必須建立大型的以癲癇為重點的現場團隊，並拜訪這些癲癇中心。我們在帳戶轉換方面取得了一些成功，從而能夠發展該業務。但正如您所提到的，我們這樣做的關鍵戰略驅動力之一是讓患者更早地了解進行 RNS 植入的診斷過程。

And while it's still early a couple of quarters in, the strategy and the basic rationale behind the deal is really coming together nicely. We are getting accounts that are using the DIXI product. We have good examples of the visibility that, that provides, understanding what they're doing and then what those centers are doing in the diagnostic process and being able to have that be helpful not just in generating revenue for DIXI but also pulling that through into performance for RNS and an increased adoption of the RNS system.

雖然現在還處於幾個季度的早期，但該交易背後的戰略和基本原理確實很好地結合在一起。我們正在獲取使用 DIXI 產品的帳戶。我們有很好的例子來說明可見性，了解他們正在做什麼，然後了解這些中心在診斷過程中正在做什麼，並且能夠讓這不僅有助於為 DIXI 創造收入，而且還能將其帶入RNS 的性能以及 RNS 系統的更多采用。

So no numbers specifically that go along with that, but I feel very good about the 2 pillars of that deal, more competitive conversions, the ability to drive more revenue through our field team and the visibility and pull-through that we think that, that will provide for the RNS business as well.

因此，沒有具體的數字與之相符，但我對該交易的兩大支柱感到非常滿意，即更具競爭力的轉換、通過我們的現場團隊推動更多收入的能力以及我們認為的可見性和拉動性還將提供 RNS 業務。

Our next question comes from Michael Polark from Wolfe Research.

我們的下一個問題來自沃爾夫研究中心的邁克爾·波拉克。

If you've said it, I missed it, I want to be precise on the revenue for the 3 lines. I heard $1.2 million of replacement. I heard DIXI over-performed, but I didn't hear a number. And so I don't know precisely what new patient revenue was. Can I get the DIXI number or just kind of -- can we go through the 3 lines individually, I didn't see them in the press release?

如果你已經說過了，我錯過了，我想準確地說明這 3 條線路的收入。我聽說更換費用為 120 萬美元。我聽說 DIXI 表現過度，但我沒有聽到數字。所以我不知道新病人的收入到底是多少。我可以得到 DIXI 號碼嗎？或者只是——我們可以單獨瀏覽一下這 3 行嗎？我在新聞稿中沒有看到它們？

The revenue for the quarter overall had meaningful growth from Q4 of last year for both the RNS initial implant and for DIXI Medical. Both of those -- both of those pieces grew significantly from Q4 of 2022 into Q1 of 2023. We haven't broken out specifically the amount of growth for DIXI and the amount of growth for the RNS implants, primarily for competitive reasons is we're just being very conscious of what that means within the space.

RNS 初始植入和 DIXI Medical 的整體收入較去年第四季度有了顯著增長。從 2022 年第四季度到 2023 年第一季度，這兩部分都顯著增長。我們沒有具體列出 DIXI 的增長量和 RNS 植入物的增長量，主要是出於競爭原因，我們“我們只是非常清楚這在空間中意味著什麼。

But as you're putting together your models, primarily, the increase was coming from initial implant revenue but very close with that growth from the DIXI medical product. And then the revenue from replacement implants coming in at $1.2 million, which was a decrease from Q4 of last year, as expected, by more revenue in the first quarter than what we had anticipated based on the timing of when in the year those replacements were happening.

但當您將模型組合在一起時，增長主要來自初始植入物收入，但與 DIXI 醫療產品的增長非常接近。然後，替換植入物的收入為 120 萬美元，與去年第四季度相比有所下降，正如預期的那樣，第一季度的收入比我們根據當年替換植入物的時間預期的要多。正在發生。

Fair enough. Our problems perhaps you got it a little harder, but enough to work with. Follow-up question is, look, early days on DIXI, it sounds like so far so good on a number of levels. I'm not asking for specifics, but are there other things like this that you could do and drop in the bag to leverage your commercial platform? Again, is there potentially a pipeline that you think about and consider or was this a one-off opportunity and behind it unlikely anything else?

很公平。我們的問題也許讓你覺得有點困難，但足以解決。後續問題是，看，DIXI 的早期階段，聽起來到目前為止在很多層面上都很好。我並不是要求提供具體細節，但您是否可以做其他類似的事情並放入袋子中以利用您的商業平台？再說一次，您是否考慮過潛在的管道，或者這是一個一次性的機會，而其背後不可能有其他東西？

I'm not going to give a specific answer to that other than to say we're always looking for where there are good fits -- strategic fits for the business. That made a lot of sense for us for many reasons that we've talked about for the DIXI product. And when we saw that, we went after that aggressively to be able to get that into our product mix. We continue to monitor that. If there's another opportunity that's like that we would be very opportunistic around that, but there's nothing that I can talk about as specifics that are active or things that we're pursuing there.

我不會對此給出具體答案，只是說我們一直在尋找合適的地方——適合業務的戰略。這對我們來說很有意義，原因有很多，我們已經討論過 DIXI 產品的原因。當我們看到這一點時，我們積極追求這一點，以便能夠將其納入我們的產品組合中。我們將繼續關注這一情況。如果還有類似的機會，我們會非常投機取巧，但我無法談論任何積極的細節或我們正在追求的事情。

I would now like to turn it back to NeuroPace for any closing remarks.

我現在想把它轉回 NeuroPace 以供結束語。

Yes. Thanks for the comments. Really happy to report the results from the first quarter, lots of strength for us across the business with all aspects of our revenue coming in very strong for the quarter and what that means for us, continue to see differentiation from our approach with responsive neuromodulation versus the other approaches that are available for these patients. So trying to close that treatment gap and get more of these patients being treated.

是的。感謝您的評論。非常高興地報告第一季度的結果，我們整個業務都有很大的優勢，本季度我們收入的各個方面都非常強勁，這對我們意味著什麼，繼續看到我們的響應式神經調節方法與這些患者可以使用的其他方法。因此，我們要努力縮小治療差距，讓更多患者得到治療。

We continue to be reminded of the benefit of responsive neurostimulation with the approach that we're taking there being a differentiated outcome versus the other approaches. There's new data that continue to come out on a regular basis. There's a study in neurology that was published recently that really highlights the challenges associated with side effect profiles and efficacy with other duty cycle kind of approaches and really the benefits of responsive neuromodulation within this space.

我們不斷提醒我們，響應性神經刺激的好處，我們所採用的方法與其他方法相比具有差異化的結果。新數據不斷定期出現。最近發表的一項神經學研究真正強調了與副作用相關的挑戰和其他工作週期類型方法的功效，以及該領域內響應性神經調節的真正好處。

And so, looking forward to getting more of the patients with drug-resistant epilepsy and focal epilepsy treated the work that we're doing to expand into generalized epilepsy and the progress there. I really appreciate everybody's time today and hope you all have a great evening.

因此，期待更多的耐藥性癲癇和局灶性癲癇患者能夠接受我們正在開展的工作以擴展到全身性癲癇以及那裡的進展。我非常感謝大家今天抽出時間並希望大家度過一個愉快的夜晚。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝您參加今天的會議。這確實結束了該程序。您現在可以斷開連接。