Neuropace Inc (NPCE) 2022 Q4 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good afternoon, and welcome to NeuroPace's Fourth Quarter Earnings Conference Call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes.

    下午好,歡迎來到 NeuroPace 的第四季度收益電話會議。 (操作員說明)作為提醒,正在錄製此通話以供重播。

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

    我現在想把電話轉給 Gilmartin Group 的 Trip Taylor,請他做一些介紹性的評論。

  • Philip Taylor - Associate

    Philip Taylor - Associate

  • 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.

    謝謝你,運營商。下午好,感謝您參加今天的電話會議。和我一起來自 NeuroPace 的是首席執行官 Mike Favet;和首席財務官麗貝卡·庫恩 (Rebecca Kuhn)。

  • Earlier today, NeuroPace released financial results for the fourth quarter and full year ended December 31, 2022. A copy of the press release is available on the company's website.

    今天早些時候, NeuroPace 發布了截至2022年12月31日的第四季度和全年的財務業績。新聞稿的副本可在公司網站上獲取。

  • Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the 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《私人證券訴訟改革法》的安全港條款作出的1995 年。在本次電話會議期間作出的與對未來事件、結果或業績的預期或預測相關的任何陳述都是前瞻性陳述。

  • 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 upon 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,包括與 NeuroPace 的商業機會、市場狀況、臨床試驗相關的陳述,以及與我們的經營趨勢和未來財務業績、COVID-19 對我們業務的影響和復蘇前景、費用管理、市場機會相關的陳述、收入前景和商業擴張是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 quarterly report on Form 10-Q for the quarter ended September 30, 2022, and our annual report on Form 10-K for the year ended December 31, 2022, 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的風險因素部分,包括我們截至 2022 年 9 月 30 日的季度 10-Q 表季度報告和我們的年度報告向美國證券交易委員會提交截至 2022 年 12 月 31 日止年度的 10-K 表格報告,以及我們將來可能向美國證券交易委員會提交的任何報告。

  • This conference call contains time-sensitive information, which we believe is accurate only as of this live broadcast on March 2, 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.

    此電話會議包含時間敏感的信息,我們認為這些信息僅在 2023 年 3 月 2 日的直播時是準確的。除法律要求外,NeuroPace 不承擔更新或修改任何財務預測或前瞻性預測的任何意圖或義務陳述,無論是因為新信息、未來事件還是其他原因。

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

    有了這個,我現在將把電話轉給邁克。

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Thanks, Trip. Good afternoon, everyone, and thank you for joining us. Today, I will highlight our fourth quarter performance and update you on the priorities we are intending to focus on in 2023, before turning the call over to Rebecca to detail the financial results and opening the call to questions.

    謝謝,旅行。大家下午好,感謝您加入我們。今天,我將重點介紹我們第四季度的業績,並向您介紹我們打算在 2023 年重點關注的優先事項,然後將電話轉給 Rebecca 詳細介紹財務業績並開始提問。

  • Before we begin, I want to highlight our key accomplishments from a productive 2022. In our first full year as a public company, we drove meaningful adoption of our RNS System, increasing utilization within the comprehensive epilepsy centers, or CECs, and adding more implanting centers. We also became the exclusive U.S. distributor of the stereo EEG products produced by DIXI Medical. This provides us with not only an additional revenue stream through our established sales channel, but also visibility into patients being worked through the diagnostic process who are potential candidates for RNS Therapy.

    在我們開始之前,我想強調我們在富有成效的 2022 年取得的主要成就。在我們作為上市公司的第一個完整年度,我們推動了我們 RNS 系統的有意義的採用,提高了綜合性癲癇中心或 CEC 的利用率,並增加了更多的植入中心。我們還成為 DIXI Medical 生產的立體腦電圖產品的美國獨家經銷商。這不僅通過我們已建立的銷售渠道為我們提供了額外的收入來源,而且還使我們能夠了解正在接受診斷過程的患者,這些患者是 RNS 治療的潛在候選人。

  • We also made meaningful progress toward expanding the RNS indication, specifically through our NAUTILUS pivotal study for primary generalized epilepsy. We accomplished all of this while reducing cash burn in the second half of 2022 to approximately $15 million compared to approximately $23 million in the first half of 2022. I will provide more color on these accomplishments and how they position us well for 2023 and beyond.

    我們還在擴大 RNS 適應症方面取得了有意義的進展,特別是通過我們針對原發性全身性癲癇的 NAUTILUS 關鍵研究。我們完成了所有這一切,同時將 2022 年下半年的現金消耗從 2022 年上半年的約 2300 萬美元減少到約 1500 萬美元。我將提供更多關於這些成就的顏色,以及它們如何使我們在 2023 年及以後處於有利地位。

  • Starting with our fourth quarter performance. Total revenue for the fourth quarter was $12.8 million, representing growth of 16% compared to the prior year period and 15% compared to the third quarter of 2022. This was primarily driven by increased adoption of our RNS System, evidenced by strong initial implant revenue of $9.8 million, representing growth of 15% compared to the prior year period and 7% sequentially.

    從我們第四季度的表現開始。第四季度的總收入為 1280 萬美元,與去年同期相比增長 16%,與 2022 年第三季度相比增長 15%。這主要是由於我們的 RNS 系統的採用率增加,初始植入物收入強勁就是明證980 萬美元,較上年同期增長 15%,環比增長 7%。

  • This was coupled with revenue contribution from the distribution of DIXI Medical products, which was slightly ahead of expectations at $1.6 million in our first quarter selling this product line.

    這與 DIXI Medical 產品分銷的收入貢獻相結合,在我們銷售該產品線的第一季度達到 160 萬美元,略高於預期。

  • We believe epilepsy monitoring unit, or EMU, patient volumes remained stable throughout the fourth quarter with no significant disruption since the first quarter of 2022. As a reminder, diagnostic evaluation in the EMU is the initial step in evaluating treatment options, including the potential use of RNS.

    我們認為,癲癇監測單位 (EMU) 的患者數量在整個第四季度保持穩定,自 2022 年第一季度以來沒有出現重大中斷。提醒一下,EMU 中的診斷評估是評估治療方案的初始步驟,包括潛在用途的 RNS。

  • Stability in the EMU supports the pipeline of interventional therapy candidates, including candidates for RNS Therapy. We continue to execute commercially in the normalizing operating environment one that we do not believe has yet returned to pre-pandemic levels and have been successful in driving physician and patient awareness of the clinical benefit and differentiated features of our RNS System.

    EMU 的穩定性支持介入治療候選人的管道,包括 RNS 治療的候選人。我們繼續在正常化的操作環境中進行商業執行,我們認為該環境尚未恢復到大流行前的水平,並且已經成功地推動了醫生和患者對我們 RNS 系統的臨床益處和差異化特徵的認識。

  • As a result, we are seeing a trend of increasing utilization, meaning that more patients are getting the benefit of RNS Therapy. Considering this momentum, we expect total 2023 revenue of $50 million to $52 million compared to $45.5 million in 2022. Our growth will be driven primarily by increasing RNS utilization within CEC and a full year of selling the DIXI Medical products.

    因此,我們看到了利用率增加的趨勢,這意味著更多的患者正在受益於 RNS 療法。考慮到這一勢頭,我們預計 2023 年的總收入為 5000 萬至 5200 萬美元,而 2022 年為 4550 萬美元。我們的增長將主要由 CEC 內 RNS 利用率的提高和 DIXI 醫療產品的全年銷售推動。

  • Growth in these areas will be offset by declining replacement implant revenue as the remaining first-generation devices reach end of service and are replaced by our second-generation device with a nearly 11-year battery life.

    這些領域的增長將被替換植入物收入的下降所抵消,因為剩餘的第一代設備將達到服務終止狀態,並被我們的電池壽命接近 11 年的第二代設備所取代。

  • Commercially, our priority is to increase utilization of the RNS System. Our strategy concentrates on 3 objectives: one, expanding patient selection; two, managing the patient pipeline and three, driving adoption of the RNS system by additional prescribers and additional implanting centers.

    在商業上,我們的首要任務是提高 RNS 系統的利用率。我們的戰略集中在三個目標上:一是擴大患者選擇範圍;第二,管理患者管道,第三,推動更多處方者和更多植入中心採用 RNS 系統。

  • To expand patient selection, our team is focused on physician education. Our goal is to increase physician awareness of the benefits of the RNS System for all indicated focal epilepsy patient subgroups. The RNS System is highly versatile, with the ability to position leads throughout the brain and customize detection and stimulation in a way that allows treatment of a full range of focal epilepsy onset locations. We have compiled compelling clinical evidence showing the differentiated benefits of RNS Therapy across these patient subgroups, and we are working to ensure these data are understood by more physicians. We believe this will help inform deeper integration of RNS system into their treatment algorithms for a broader set of patients.

    為了擴大患者選擇範圍,我們的團隊專注於醫師教育。我們的目標是提高醫生對 RNS 系統對所有適應症局灶性癲癇患者亞組益處的認識。 RNS 系統用途廣泛,能夠在整個大腦中定位導線並定制檢測和刺激,從而可以治療各種局灶性癲癇發作部位。我們收集了令人信服的臨床證據,顯示 RNS 療法在這些患者亞組中的差異化優勢,我們正在努力確保更多醫生了解這些數據。我們相信這將有助於將 RNS 系統更深入地整合到他們針對更廣泛患者的治療算法中。

  • We are also working to close the treatment gap by guiding epileptologists and neurosurgeons to evaluate more drug-resistant epilepsy patients or interventional therapy so that more of their patients can realize the life-changing benefits provided by RNS Therapy.

    我們還致力於通過指導癲癇病學家和神經外科醫生評估更多耐藥性癲癇患者或介入治療來縮小治療差距,以便更多患者能夠意識到 RNS 療法提供的改變生活的益處。

  • Our next objective is to actively manage every level of the patient funnel. We believe that identifying and educating potential RNS patients earlier in their treatment journey is critical for increasing RNS utilization. At the top of the patient funnel, we are adding weeds using direct-to-consumer efforts, and through our field team working within the CECs, including through our work in the EMUs with the DIXI Medical stereo EEG products.

    我們的下一個目標是積極管理患者漏斗的每個級別。我們認為,在治療過程中儘早識別和教育潛在的 RNS 患者對於提高 RNS 利用率至關重要。在患者漏斗的頂部,我們正在通過直接面向消費者的努力添加雜草,並通過我們在 CEC 內工作的現場團隊,包括通過我們在 EMU 中使用 DIXI Medical 立體腦電圖產品的工作。

  • We utilize nurse navigators who help guide these patients lead through the diagnostic process. We also provide patient education on the RNS System through our commercial team and a network of patient ambassadors. We believe that our efforts to manage the patient pipeline from end to end will be a key factor in increasing RNS therapy utilization.

    我們利用護士導航員幫助指導這些患者完成診斷過程。我們還通過我們的商業團隊和患者大使網絡提供有關 RNS 系統的患者教育。我們相信,我們從頭到尾管理患者管道的努力將成為提高 RNS 治療利用率的關鍵因素。

  • As a reminder, we are the exclusive distributor of DIXI Medical stereo EEG lead, which is the diagnostic device 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 before intervention.

    提醒一下,我們是 DIXI Medical 立體腦電圖導聯的獨家經銷商,這是一種用於確定癲癇發作起源的診斷設備。在美國,大多數 RNS 患者和大多數手術切除和消融患者在干預前都通過立體腦電圖進行定位。

  • Distribution of these products is not only an incremental revenue stream, but is providing the opportunity for earlier patient engagement, where we believe we can have a greater impact and a stronger voice explaining the benefits of the RNS system. Q4 was our first quarter distributing the DIXI Medical products, and we are encouraged by our early progress. We are confident this partnership will have a positive impact on the RNS patient pipeline.

    這些產品的分銷不僅是一個增量收入流,而且還為早期患者參與提供了機會,我們相信我們可以在其中產生更大的影響和更強的聲音來解釋 RNS 系統的好處。第 4 季度是我們分銷 DIXI Medical 產品的第一季度,我們對我們的早期進展感到鼓舞。我們相信這種夥伴關係將對 RNS 患者管道產生積極影響。

  • Third, we believe that driving adoption by additional prescribers and bringing on new implanting centers will also contribute to our overall growth. The sales force expansion completed in 2022 has enabled and will continue to enable this team to cover a greater portion of the market, and we intend to leverage that to introduce our RNS system more broadly.

    第三,我們相信,推動更多處方者的採用和建立新的植入中心也將有助於我們的整體增長。 2022 年完成的銷售人員擴張已經並將繼續使該團隊能夠覆蓋更大的市場份額,我們打算利用它來更廣泛地引入我們的 RNS 系統。

  • These 3 commercial objectives are designed to increase utilization of the RNS System and CECs and support our initial implant revenue growth in 2023.

    這 3 個商業目標旨在提高 RNS 系統和 CEC 的利用率,並支持我們在 2023 年的初始植入收入增長。

  • I will now provide an update on replacement revenue. As expected, in the fourth quarter, replacement revenue was $1.4 million, which represents a decline of 44% compared to the prior year period. As of December 31, 2022, there were 56 patients being actively treated with first-generation RNS devices. We do not plan to provide this metric going forward as we do not expect it to represent a material part of our business in 2023.

    我現在將提供有關替代收入的最新信息。正如預期的那樣,第四季度的替換收入為 140 萬美元,與去年同期相比下降了 44%。截至 2022 年 12 月 31 日,有 56 名患者正在接受第一代 RNS 設備的積極治療。我們不打算在未來提供該指標,因為我們預計它不會在 2023 年代表我們業務的重要組成部分。

  • We continue to expect quarterly replacement revenue to sequentially decline through the year as the remaining first-generation devices are replaced with the second-generation device with a longer-lasting battery. We believe that we will have completed the transition process by the end of 2023.

    我們繼續預計,隨著剩餘的第一代設備被電池壽命更長的第二代設備所取代,季度更換收入將在全年依次下降。我們相信我們將在 2023 年底之前完成過渡過程。

  • Moving to our clinical trial updates. Generalized epilepsy continues to be our top clinical priority. In 2022, we initiated enrollment in our NAUTILUS study. The NAUTILUS study is designed to evaluate the safety and efficacy of the RNS System for the treatment of primary generalized epilepsy. We intend for the results from this study to support a PMA supplement to expand the RNS System indication.

    轉到我們的臨床試驗更新。全身性癲癇仍然是我們的首要臨床重點。 2022 年,我們開始招募 NAUTILUS 研究。 NAUTILUS 研究旨在評估 RNS 系統治療原發性全身性癲癇的安全性和有效性。我們打算讓這項研究的結果支持 PMA 補充,以擴大 RNS 系統適應症。

  • I am pleased to report that all 25 participating sites are now active and are seeking to enroll patients in the study. We also continue to make good progress on the NIH-funded feasibility study for patients with Lennox-Gastaut syndrome, a type of symptomatic generalized epilepsy. Generalized epilepsy represents a meaningful market expansion opportunity. 40% of drug-resistant epilepsy patients have generalized epilepsy, and diagnosis of these patients is simpler and faster than for focal epilepsy. We believe that RNS Therapy represents the optimal intervention for these patients as resection and ablation are not applicable for generalized epilepsy, and there is no FDA-approved neuromodulation therapy for this indication.

    我很高興地報告所有 25 個參與站點現在都處於活動狀態,並且正在尋求讓患者參與研究。我們還在 NIH 資助的針對 Lennox-Gastaut 綜合徵(一種有症狀的全身性癲癇)患者的可行性研究方面繼續取得良好進展。全身性癲癇代表了一個有意義的市場擴張機會。 40%的耐藥性癲癇患者為全身性癲癇,這些患者的診斷比局灶性癲癇更簡單、更快捷。我們認為 RNS 療法代表了這些患者的最佳干預措施,因為切除和消融不適用於全身性癲癇,並且沒有 FDA 批准的針對該適應症的神經調節療法。

  • To wrap up, as I look back on 2022, I can proudly say that we have been able to make significant progress across our business. We drove increased RNS system utilization. We expanded our field team and optimized our commercial process. We successfully initiated distribution of DIXI Medical Products for stereo EEG. We made important progress towards expanding our indication into generalized epilepsy by beginning enrollment in the NAUTILUS study and the LGS study. We did all of this while reducing our cash burn to approximately $15 million in the second half of 2022.

    總而言之,當我回顧 2022 年時,我可以自豪地說,我們已經能夠在我們的業務中取得重大進展。我們提高了 RNS 系統的利用率。我們擴大了我們的現場團隊並優化了我們的商業流程。我們成功地開始分銷用於立體腦電圖的 DIXI 醫療產品。通過開始參加 NAUTILUS 研究和 LGS 研究,我們在將適應症擴展到全身性癲癇方面取得了重要進展。我們做到了所有這些,同時在 2022 年下半年將我們的現金消耗減少到大約 1500 萬美元。

  • With over $77 million of cash available at the end of 2022, at this burn rate, we would have more than 2 years of available capital. Collectively, these accomplishments have positioned NeuroPace well for 2023 and beyond.

    到 2022 年底,我們有超過 7700 萬美元的可用現金,按照這個消耗率,我們將擁有超過 2 年的可用資本。總的來說,這些成就使 NeuroPace 在 2023 年及以後處於有利地位。

  • With that, I will now turn the call over to Rebecca to detail the fourth quarter and full year financial results.

    有了這個,我現在將把電話轉給麗貝卡,詳細說明第四季度和全年的財務業績。

  • Rebecca L. Kuhn - CFO, VP of Finance & Administration and Assistant Secretary

    Rebecca L. Kuhn - CFO, VP of Finance & Administration and Assistant Secretary

  • Thanks, Mike. NeuroPace's revenue for the fourth quarter of 2022 was $12.8 million, representing growth of 16% compared to $11 million for the fourth quarter of 2021 and 15% sequentially compared to $11.2 million in the third quarter of 2022.

    謝謝,邁克。 NeuroPace 2022年第四季度的收入為1280萬美元,與2021年第四季度的1100萬美元相比增長16%,與2022年第三季度的1120萬美元相比增長15%。

  • In the fourth quarter, revenue from initial implants grew 15% to $9.8 million compared to $8.5 million for the fourth quarter of 2021. Sequentially, initial implant revenue in the fourth quarter grew 7% compared to the third quarter. The increase in revenue was largely due to an increase in initial implant procedure. Revenue from replacement implant was $1.4 million compared to $2.5 million in the fourth quarter of 2021.

    第四季度,初始植入物的收入增長了 15%,達到 980 萬美元,而 2021 年第四季度為 850 萬美元。因此,第四季度的初始植入物收入比第三季度增長了 7%。收入的增加主要是由於初始植入程序的增加。置換植入物的收入為 140 萬美元,而 2021 年第四季度為 250 萬美元。

  • We continue to expect replacement implant revenue generally to decrease through the end of 2023 until we have completed the transition to the second-generation device. This means that we expect revenue only from replacements of our second-generation devices after this year. We expect this will be a growth driver for our business when more of the second-generation devices reach into battery life and are ready for replacement.

    我們繼續預計,到 2023 年底,更換植入物的收入將普遍下降,直到我們完成向第二代設備的過渡。這意味著我們預計今年之後只能通過更換我們的第二代設備獲得收入。我們預計,當更多的第二代設備達到電池壽命並準備更換時,這將成為我們業務的增長動力。

  • Gross margin for the fourth quarter of 2022 was 69% compared to 73% in the fourth quarter of 2021. The decline in gross margin relative to the prior year period was primarily due to distributing DIXI Medical products, which have a lower gross margin than our core RNS business.

    2022 年第四季度的毛利率為 69%,而 2021 年第四季度為 73%。毛利率較上年同期下降主要是由於分銷 DIXI Medical 產品,其毛利率低於我們的毛利率核心 RNS 業務。

  • The fourth quarter of 2022 was our first quarter distributing DIXI Medical products, and we expect gross margins to generally increase from that level. Total operating expenses in the fourth quarter of 2022 were $18.7 million compared with $17.1 million in the same period of the prior year. Operating expenses in the fourth quarter, including onetime costs associated with the DIXI Medical partnership launch, increased by 3% compared to the third quarter.

    2022 年第四季度是我們分銷 DIXI Medical 產品的第一季度,我們預計毛利率將普遍高於該水平。 2022 年第四季度的總運營費用為 1870 萬美元,上年同期為 1710 萬美元。第四季度的運營費用,包括與 DIXI Medical 合作夥伴關係啟動相關的一次性成本,與第三季度相比增長了 3%。

  • As expected, operating expenses for our core RNS business decreased slightly in the fourth quarter compared to the third quarter.

    正如預期的那樣,與第三季度相比,第四季度我們核心 RNS 業務的運營費用略有下降。

  • We plan to continue to focus on initiatives to optimize operating expenses through 2023. R&D expense in the fourth quarter of 2022 was $5.1 million compared with $5.3 million in the same period of 2021. The decrease in R&D expense was primarily driven by a decrease in personnel-related expenses.

    我們計劃在 2023 年之前繼續專注於優化運營費用的舉措。2022 年第四季度的研發費用為 510 萬美元,而 2021 年同期為 530 萬美元。研發費用的減少主要是由於人員減少所致- 相關費用。

  • SG&A expense in the fourth quarter of 2022 was $13.6 million compared with $11.7 million in the prior year period. The increase in SG&A was primarily driven by DIXI Medical partnership launch expenses and personnel-related expenses. Loss from operations was $9.9 million in the fourth quarter of 2022 compared with $9 million in the prior year period.

    2022 年第四季度的 SG&A 費用為 1360 萬美元,而去年同期為 1170 萬美元。 SG&A 的增加主要是由 DIXI Medical 合作夥伴啟動費用和人員相關費用推動的。 2022 年第四季度的運營虧損為 990 萬美元,而去年同期為 900 萬美元。

  • We recorded $1.9 million in interest expense in the fourth quarter compared to $1.9 million in the prior year period. Net loss was $11.1 million for the fourth quarter of 2022 compared to $10.7 million in the fourth quarter of 2021. Our cash and short-term investments balance as of December 31, 2022, was $77.4 million and our burn rate in the second half of the year was approximately $15 million compared to approximately $23 million in the first half of the year. Our long-term borrowings totaled $52.9 million as of December 31, 2022, with the full principal due on September 30, 2025.

    我們在第四季度記錄了 190 萬美元的利息支出,而去年同期為 190 萬美元。 2022 年第四季度的淨虧損為 1110 萬美元,而 2021 年第四季度為 1070 萬美元。截至 2022 年 12 月 31 日,我們的現金和短期投資餘額為 7740 萬美元,下半年的消耗率與上半年的約 2300 萬美元相比,今年的收入約為 1500 萬美元。截至 2022 年 12 月 31 日,我們的長期借款總額為 5290 萬美元,本金將於 2025 年 9 月 30 日到期。

  • Now turning to our outlook for 2023. For 2023, we expect revenue to range between $50 million and $52 million. Growth will be supported mainly by increases in initial implants and revenue from the sale of DIXI Medical products. As discussed, replacement revenue is expected to decline this year.

    現在轉向我們對 2023 年的展望。對於 2023 年,我們預計收入將在 5000 萬美元至 5200 萬美元之間。增長將主要受到初始植入物的增加和 DIXI 醫療產品銷售收入的支持。如前所述,預計今年的替代收入將下降。

  • Gross margin for 2023 is expected to be between 69% and 71%, potentially a slight improvement from the 69% generated in the fourth quarter, which was our first full quarter with DIXI Medical revenue contribution. As a result of the distribution agreement for the DIXI Medical partnership, that revenue produces a lower gross margin than our base business. Fluctuations in the proportion of DIXI Medical revenue to overall revenue will create small variability in our quarterly gross margins.

    2023 年的毛利率預計在 69% 至 71% 之間,可能比第四季度的 69% 略有改善,第四季度是我們第一個完整的季度,DIXI 醫療收入貢獻。由於 DIXI Medical 合作夥伴關係的分銷協議,該收入產生的毛利率低於我們的基礎業務。 DIXI Medical 收入佔總收入比例的波動將對我們的季度毛利率造成小幅波動。

  • Operating expenses for 2023 are expected to range between $75 million and $77 million, including $11 million to $12 million in noncash expenses. Lastly, it is important to highlight that our cash burn rate for the second half of 2022 was approximately $15 million. We were able to reduce our cash burn in the second half of the year compared to the first half of the year because of the spending discipline and cost controls we implemented starting in the middle of the year. We intend to maintain that level of discipline in 2023.

    2023 年的運營支出預計在 7500 萬至 7700 萬美元之間,其中包括 1100 萬至 1200 萬美元的非現金支出。最後,需要強調的是,我們 2022 年下半年的現金消耗率約為 1500 萬美元。由於我們從年中開始實施支出紀律和成本控制,與上半年相比,我們能夠在下半年減少現金消耗。我們打算在 2023 年保持這種紀律水平。

  • Given our cash balance at year-end of 2022 and our ongoing efforts to reduce our burn rate, we do not believe we will have a need to raise capital in the next 12 months.

    鑑於我們在 2022 年底的現金餘額以及我們為降低燃燒率所做的持續努力,我們認為我們在未來 12 個月內不需要籌集資金。

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

    我們準備好的發言到此結束。我現在想把電話轉回給接線員,接線員會打開電話詢問問題。

  • Operator

    Operator

  • (Operator Instructions) And our first question comes from Michael Polark from Wolfe Research.

    (操作員說明)我們的第一個問題來自 Wolfe Research 的 Michael Polark。

  • Michael K. Polark - Director & Senior Analyst

    Michael K. Polark - Director & Senior Analyst

  • Maybe to start. Curious, Mike, for your assessment of the top of the funnel. It sounds like the last 9 months of 2022 were steady in terms of EMU admissions, and that's obviously a good leading indicator for new patient implants.

    也許開始。好奇,邁克,你對漏斗頂部的評估。聽起來 2022 年的最後 9 個月在 EMU 入院方面保持穩定,這顯然是新患者植入的一個很好的領先指標。

  • To what extent -- to what do you attribute this? And then kind of how durable and consistent can it be from here? And I guess the other angle to this question is, do you think there's any element of catch-up the last 9 months of 2022? The extended COVID disruption might have precluded patients from engaging in the system. Do you think that's contributing abnormally to what you saw in the back half of the year? Or do you think we're kind of we're at a stable steady state, and this is a level of new admissions that can be sustained in '23?

    在多大程度上——您將此歸因於什麼?然後它的耐用性和一致性如何?我想這個問題的另一個角度是,你認為 2022 年的最後 9 個月有任何追趕的因素嗎?延長的 COVID 中斷可能會阻止患者參與該系統。你認為這對你在今年下半年看到的情況有異常貢獻嗎?還是您認為我們處於穩定狀態,這是 23 年可以維持的新入學水平?

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Great. Thanks for the question, Mike. So jumping into the stability that we've seen in the market over the last 3 quarters or so. Largely, I attribute that to having not -- we have not had any significant COVID-related disruptions since Q1 of last year.

    偉大的。謝謝你的問題,邁克。因此,進入我們在過去 3 個季度左右的市場中看到的穩定性。在很大程度上,我將其歸因於沒有——自去年第一季度以來,我們沒有遇到任何與 COVID 相關的重大中斷。

  • The market has been relatively stable from that perspective, and that's allowed centers to be able to get back to a new normal for patients coming through the epilepsy centers. We don't -- we don't believe that the epilepsy centers are all the way back to pre-pandemic levels yet, primarily because of staffing limitations that some of the hospitals have had. So we're not getting COVID disruptions, but there are staffing challenges that some of these centers have had.

    從這個角度來看,市場一直相對穩定,這使得中心能夠為來自癲癇中心的患者恢復到新常態。我們不——我們不相信癲癇中心已經完全恢復到大流行前的水平,這主要是因為一些醫院的人員配備有限。因此,我們沒有受到 COVID 中斷,但其中一些中心面臨人員配備挑戰。

  • I haven't seen what I'll call a surge of makeup that's coming through the centers. It's really allowing them to get back to a flow of patients that are coming through the centers. And given that we're not back to pre-pandemic levels yet, at least we believe that we're not, and the hospitals are working to bring in the staffing,. I do expect, over time, there's an opportunity for that volume to increase.

    我還沒有看到我稱之為通過中心的化妝浪潮。這真的讓他們能夠回到通過中心的病人流中。鑑於我們還沒有回到大流行前的水平,至少我們相信我們沒有,而且醫院正在努力增加人員配置。我確實希望,隨著時間的推移,這個數量有機會增加。

  • And then historically, prior to the pandemic, most of the growth, the volume of patients coming through the epilepsy centers, was driven by more epilepsy centers being created. And I'm starting to hear out in the community that there's more activity around that again, where centers are hiring an epileptologist looking to bring in surgeons to be able to create new epilepsy centers, which provides another opportunity for the market to grow overall.

    然後從歷史上看,在大流行之前,大部分增長,即通過癲癇中心的患者數量,是由更多癲癇中心的創建推動的。我開始在社區中聽到圍繞這方面的活動再次增多,中心正在聘請一名癲癇病學家,希望引進外科醫生,以便能夠創建新的癲癇中心,這為市場的整體增長提供了另一個機會。

  • So I think stability, no significant COVID disruptions, and that's put us in a position to be able to show the share gains that we've been able to make within the EMU, more of the patients coming through the EMU being treated, not being offset by declines in the number of patients coming through these centers.

    所以我認為穩定性,沒有重大的 COVID 中斷,這使我們能夠展示我們在 EMU 內能夠獲得的份額收益,更多通過 EMU 接受治療的患者,而不是被來自這些中心的患者數量的下降所抵消。

  • Michael K. Polark - Director & Senior Analyst

    Michael K. Polark - Director & Senior Analyst

  • Helpful. And maybe for the follow-up part of the hook with DIXI was more upstream visibility into this funnel. And I guess, I know it's early days with this distribution agreement. But kind of what are you learning with DIXI? And then is that helping you manage the flow and funnel and identify patients better?

    有幫助。也許對於與 DIXI 掛鉤的後續部分來說,這個漏斗的上游可見性更高。而且我想,我知道這個分銷協議還處於早期階段。但是你在 DIXI 上學到了什麼?那麼,這是否有助於您更好地管理流程和漏斗並識別患者?

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Yes. Like you said, early days. So we're now like a quarter and a half or so into the U.S. distribution of the DIXI product. And so far, it's been very much what we had anticipated. The synergy with our field organization is very strong. And so our ability to be able to support and sell that product to our commercial organization, I feel very good about.

    是的。就像你說的,早期。所以我們現在大約四分之一半進入美國 DIXI 產品的分銷。到目前為止,這非常符合我們的預期。與我們現場組織的協同作用非常強大。因此,我們能夠支持該產品並將其銷售給我們的商業組織,我對此感覺非常好。

  • And the early -- I'm going to call them more anecdotes than broad spread evidence, but the early anecdotes are consistent with that hypothesis where we're able to get better insight into what is happening in the flow of patients through the epilepsy centers, how many patients are coming through the Phase II studies that lead to therapies like the RNS system implant, and then being able to use that to provide more sales opportunity -- selling opportunities to be able to get a higher percentage of those patients moving on to the RNS System.

    早期的——我將稱它們為軼事多於廣泛傳播的證據,但早期的軼事與我們能夠更好地了解癲癇中心患者流動中發生的事情的假設一致,有多少患者正在通過 II 期研究,這些研究導致像 RNS 系統植入這樣的療法,然後能夠利用它來提供更多的銷售機會——銷售機會能夠讓更多的患者繼續前進到 RNS 系統。

  • So early days, more anecdote than anything that I can say beyond that, but I am very encouraged by both the sales synergy as well as the impact that we think that's going to have for us on the pipeline.

    這麼早的日子,除此之外,我能說的軼事多於軼事,但我對銷售協同效應以及我們認為這將對我們產生的影響感到非常鼓舞。

  • Operator

    Operator

  • And 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。

  • Frank James Takkinen - Senior Research Analyst

    Frank James Takkinen - Senior Research Analyst

  • Congrats on the progress. I wanted to start with one on the guidance. I heard the comments a lot and clear about the drivers of growth, your initial implants and DIXI offset by replacements. Can you maybe just walk through how you're thinking about low end versus top end? What needs to occur to hit the top end? What could happen to hit the bottom end? And then what's kind of the upside scenario to -- what needs to occur to exceed the top end of the guide?

    祝賀進步。我想從指南開始。我聽到了很多關於增長驅動因素的評論,你的初始植入物和 DIXI 被替換物抵消了。您能否簡單介紹一下您是如何考慮低端與高端的?達到頂端需要發生什麼?到底會發生什麼?那麼什麼是上行方案 - 需要發生什麼才能超過指南的頂端?

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Great. Thanks, Frank, and looking forward to being able to execute this against this in 2023. As you stated, drivers of growth are initial system implants of the RNS system and the DIXI revenue being the growth drivers.

    偉大的。謝謝,弗蘭克,並期待能夠在 2023 年對此執行此操作。正如您所說,增長的驅動力是 RNS 系統的初始系統植入,而 DIXI 收入是增長驅動力。

  • The pieces that are behind that, for the DIXI component, it's going to be about a combination of the market growth and how much share are we going to be able to take in that market. I feel very good about where we started the distribution of that product in the fourth quarter of last year, giving us a nice base to be able to build off of.

    其背後的部分,對於 DIXI 組件,它將與市場增長和我們將能夠在該市場中佔據多少份額有關。我對我們在去年第四季度開始分發該產品的地方感到非常滿意,這為我們提供了一個很好的基礎。

  • And then for the NeuroPace RNS revenue, which again is the significant majority of our revenue coming from that, there is an element of the range that comes from how fast the market recovers -- does the market recover and how fast the market recovers. We're building into expectations that the normalization that we've seen over the last 3 quarters continues through 2023.

    然後,對於 NeuroPace RNS 收入,這又是我們收入的絕大部分,其中有一個因素來自市場復甦的速度——市場是否復甦以及市場復甦的速度。我們正在建立預期,即我們在過去 3 個季度看到的正常化將持續到 2023 年。

  • There is more upside with that if the market recovers more quickly, meaning gets back to 2019 levels and grows from 2019 levels. That provides upside for us in terms of the range that we provided. And then the other primary factor is going to be about how fast can we increase the utilization within these centers. The primary growth driver of initial implants is how fast we grow initial implant utilization. And that's going to be the effectiveness of the commercial efforts and the work that we're doing to manage the pipeline for more patients coming through.

    如果市場復甦得更快,這意味著它會回到 2019 年的水平並從 2019 年的水平增長。就我們提供的範圍而言,這為我們提供了優勢。然後另一個主要因素是我們可以多快地提高這些中心的利用率。初始植入物的主要增長驅動力是我們提高初始植入物利用率的速度。這將是商業努力的有效性,以及我們正在為管理更多患者的管道所做的工作。

  • The other factor that goes into that is how many new centers can we bring on. We're taking steps to be able to expand access of RNS system to more patients, more centers and so that provides some of that range for revenue as well.

    另一個影響因素是我們可以引進多少新中心。我們正在採取措施,以便能夠將 RNS 系統的訪問範圍擴大到更多患者、更多中心,從而也提供部分收入範圍。

  • Frank James Takkinen - Senior Research Analyst

    Frank James Takkinen - Senior Research Analyst

  • Okay. That's helpful. And then maybe for my second one on the generalized population. Can you provide any update around the enrollment? And if unable to give a specific patient numbers, maybe if you can share some goalposts around timing for enrollment completion expectations?

    好的。這很有幫助。然後也許是我的第二個關於廣義人口的問題。你能提供有關註冊的任何更新嗎?如果無法提供具體的患者人數,也許您可以分享一些關於入組完成預期時間的目標?

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Yes. Thanks for the question. So I'm really excited to have brought all of the centers into that study at this point. So being able to really focus now as we go through 2023 on driving enrollment through those centers.

    是的。謝謝你的問題。所以我真的很高興能在這一點上將所有中心都納入這項研究。因此,在我們到 2023 年時,現在能夠真正專注於通過這些中心推動入學率。

  • But the expectation is that it's going to take us on the order of a year from where we stand now to enroll the remaining patients in the NAUTILUS study. We have really all efforts around being able to get that done as soon as we can, but expect that it's going to be on an order -- on the order of about a year to be able to get through that process.

    但預期是,從我們現在所處的位置開始,我們需要大約一年的時間才能將剩餘的患者納入 NAUTILUS 研究。我們真的竭盡全力盡快完成這項工作,但預計它會在訂單上——大約一年的時間才能完成這個過程。

  • And then as a reminder, it's about -- it's a 1-year follow-up for the primary endpoint for that study. But very happy to be through the process of getting the sites online. A lot of excitement within the medical community about this, and so we were very pleased to be able to get the number and the quality of sites that we were able to participate in the trial.

    然後提醒一下,它是關於 - 這是該研究主要終點的 1 年隨訪。但是很高興能夠完成網站上線的過程。醫學界對此非常興奮,因此我們很高興能夠獲得我們能夠參與試驗的站點的數量和質量。

  • Operator

    Operator

  • And our next question comes from Robbie Marcus from JPMorgan.

    我們的下一個問題來自摩根大通的羅比馬庫斯。

  • K. Gong - Associate

    K. Gong - Associate

  • This is Allen on for Robbie. I had a quick one just on the trends you're seeing in the first quarter. It sounds like you're seeing some good stability, but just curious to see what you're seeing so far in first quarter? And also just what that implies for seasonality going from 4Q to 1Q, and then through the balance of the year?

    這是艾倫替羅比。我快速了解了您在第一季度看到的趨勢。聽起來你看到了一些很好的穩定性,但只是想看看你在第一季度到目前為止看到了什麼?這對從第 4 季度到第 1 季度,然後是全年的季節性變化意味著什麼?

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Yes. What we've seen in the start of the first quarter has been consistent with what we've been seeing in the last 3 quarters, meaning that the epilepsy monitoring units have been normalizing over that period of time. No significant COVID-related disruptions in the epilepsy centers through the first couple of months of 2023, which extends what we saw again in the last 3 quarters of 2022.

    是的。我們在第一季度初看到的情況與我們在過去 3 個季度看到的情況一致,這意味著癲癇監測單位在那段時間一直在正常化。到 2023 年的前幾個月,癲癇中心沒有出現與 COVID 相關的重大中斷,這延續了我們在 2022 年最後三個季度再次看到的情況。

  • That puts us in a nice position to be able to focus on the share gains within the epilepsy center to be able to have those come through. And overall, I think, kind of a continuation of where we exited 2022 as we started into the first couple of months of this year.

    這使我們處於一個很好的位置,能夠專注於癲癇中心的份額收益,從而能夠實現這些收益。總的來說,我認為這是我們在今年頭幾個月開始時退出 2022 年的延續。

  • K. Gong - Associate

    K. Gong - Associate

  • Got it. And then when we think about DIXI, it came in a little bit stronger in the fourth quarter. We were thinking for 2023 roughly around a $6 million contribution. Is that still the right way to think about it? And any kind of color on cadence you think about that as being more back-end loaded?

    知道了。然後當我們想到 DIXI 時,它在第四季度的表現有所增強。我們正在考慮為 2023 年提供大約 600 萬美元的捐款。這仍然是正確的思考方式嗎?你認為節奏上的任何一種顏色都被後端加載了嗎?

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Yes. The way that I think about the DIXI revenue, the fourth quarter was, I think, a good baseline for where we expect revenue for that business going forward. There's, I would say, some growth potential. There is growth potential that's associated with it. But I would think about it as being able to build off of the $1.6 million of revenue that we had in the fourth quarter. There wasn't anything that was abnormal about the fourth quarter, meaning it wasn't a stocking quarter, it was a continuation of the work that DIXI was doing when they were distributing directly in the U.S. themselves.

    是的。我認為第四季度的 DIXI 收入是我們預期該業務未來收入的良好基線。我會說,有一些增長潛力。有與之相關的增長潛力。但我認為它能夠在我們第四季度的 160 萬美元收入的基礎上繼續發展。第四季度沒有任何異常,這意味著它不是庫存季度,而是 DIXI 在美國直接分銷時所做工作的延續。

  • Prior to the fourth quarter, we were able to pick that up and continue that. So think about 1.6 as kind of the baseline and then being able to run off of that as we go through 2023.

    在第四季度之前,我們能夠接受並繼續這樣做。因此,將 1.6 視為一種基準,然後在我們經歷 2023 年時能夠擺脫它。

  • Operator

    Operator

  • And our next question comes from Larry Biegelsen from Wells Fargo.

    我們的下一個問題來自 Wells Fargo 的 Larry Biegelsen。

  • And our next question comes from Vik Chopra from Wells Fargo.

    我們的下一個問題來自富國銀行的 Vik Chopra。

  • Unidentified Analyst

    Unidentified Analyst

  • I'm not sure what happened. This is Vik in for Larry. So a couple of questions for me. About your comments on the gross margins for 2023. But just help us understand how we should think about the cadence for 2023, given the DIXI Medical agreement? And I have a follow-up.

    我不確定發生了什麼。這是拉里的維克。所以有幾個問題要問我。關於您對 2023 年毛利率的評論。但只是幫助我們了解我們應該如何考慮 2023 年的節奏,考慮到 DIXI 醫療協議?我有一個後續行動。

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Rebecca, do you want to cover that?

    麗貝卡,你想報導嗎?

  • Rebecca L. Kuhn - CFO, VP of Finance & Administration and Assistant Secretary

    Rebecca L. Kuhn - CFO, VP of Finance & Administration and Assistant Secretary

  • Sure. So we're looking for or expecting gross margin between 69% and 71% in 2023, some potential for upside based on what we saw in the fourth quarter. DIXI, obviously, has a lower gross margin than our core RNS business and the -- our gross margin will be influenced by the revenue mix between DIXI and our core business. We're not expecting anything unusual there as the year progresses. So really no major fluctuations within that revenue mix.

    當然。因此,我們正在尋找或預計 2023 年的毛利率在 69% 至 71% 之間,根據我們在第四季度看到的情況,有一定的上行潛力。顯然,DIXI 的毛利率低於我們的核心 RNS 業務,而且——我們的毛利率將受到 DIXI 與我們核心業務之間的收入組合的影響。隨著時間的推移,我們預計那裡不會出現任何異常情況。因此,收入組合中確實沒有重大波動。

  • Unidentified Analyst

    Unidentified Analyst

  • Okay. And then my follow-up, Mike, I got your comments. But could you help us understand at what pace you expect to add new centers going forward in 2023?

    好的。然後是我的後續行動,邁克,我收到了你的評論。但是您能否幫助我們了解您希望在 2023 年以何種速度增加新中心?

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Yes. Thanks for the question. So we finished last year 2022 with the 156, 156 implanting centers for the year, during the year. That was up from 150 centers the prior year. Most of the growth in our revenue -- initial implant revenue last year came from increased utilization within those centers.

    是的。謝謝你的問題。因此,我們在去年 2022 年完成了 156 個,全年有 156 個植入中心。這比前一年的 150 個中心有所增加。我們收入的大部分增長——去年的初始植入收入來自這些中心的利用率提高。

  • As we head into 2023, we're taking some steps to expand the opportunity for access to the RNS system within the United States and expect that we'll continue to add sensors through the year. So building off that 156 as we move through the year.

    隨著我們進入 2023 年,我們正在採取一些措施來擴大在美國境內訪問 RNS 系統的機會,並預計我們將在這一年中繼續增加傳感器。因此,在我們度過這一年的過程中,建立了 156 個。

  • As we go forward, I expect I'll be able to provide some additional clarity about what that means in terms of number of centers. But expect that, that's going to continue to be a driver for growth for us. That being said, primarily, we're expecting the increase in adoption of the RNS system to come from increased utilization within the center. So we've got this base of 156 centers, getting more patients being treated through those centers. But some things that we're working on to be able to make RNS available more -- even more broadly within the U.S.

    隨著我們的前進,我希望我能夠就中心數量的含義提供一些額外的清晰度。但請期待,這將繼續成為我們增長的驅動力。話雖如此,我們預計 RNS 系統採用率的增加主要來自中心內利用率的提高。所以我們有 156 個中心,讓更多的病人通過這些中心接受治療。但我們正在努力使 RNS 的使用範圍更廣——甚至在美國范圍內更廣泛。

  • Operator

    Operator

  • And our next question comes from Drew Ranieri from Morgan Stanley.

    我們的下一個問題來自摩根士丹利的 Drew Ranieri。

  • Andrew Christopher Ranieri - Equity Analyst

    Andrew Christopher Ranieri - Equity Analyst

  • Maybe just to put some math around 2023. But if I kind of take your comments on replacement revenue, I think you have 56 patients remaining. Your DIXI commentary, it looks like new patient implant growth for the year might be in the high teens kind of given your initial guide here.

    也許只是為了在 2023 年左右進行一些計算。但如果我接受你對替代收入的評論,我認為你還有 56 名患者。你的 DIXI 評論,看起來今年新患者植入物的生長可能在十幾歲左右,這裡給出了你的初步指導。

  • So just kind of curious you've kind of talked about getting back to like low to mid-20s in a normalized environment. Is that still the case? Do you think that you can do that in 2023? Is it more about just stability? Or do you need to see EMU visits get back to 2019 levels to truly kind of grow new patient implants at that growth rate?

    所以有點好奇,你談到了在正常環境中回到 20 多歲到 20 多歲的樣子。現在還是這樣嗎?你認為你能在 2023 年做到這一點嗎?更重要的是穩定性嗎?或者您是否需要看到 EMU 訪問量回到 2019 年的水平才能真正以這種增長率增長新的患者植入物?

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • So we have -- thanks for the question, Drew. We have a lot of opportunity to continue to take more of the patients coming through the epilepsy centers and get them treated with the RNS system. So the taking share of patients coming through the epilepsy centers that we've been talking about.

    所以我們 - 感謝德魯的問題。我們有很多機會繼續接收更多來自癲癇中心的患者,並讓他們接受 RNS 系統治療。因此,通過我們一直在談論的癲癇中心來的患者比例。

  • With that said, there's obviously an impact of the market growth that can contribute and expect over time that, that will contribute positively to that. And that's the -- with that, if we can get back to a point where epilepsy monitoring unit admissions are increasing, then that provides opportunity for those numbers to grow more quickly.

    話雖如此,市場增長顯然會產生影響,隨著時間的推移,市場增長會產生積極影響。這就是 - 如果我們能夠回到癲癇監測單位入院人數增加的地步,那麼這將為這些數字提供更快增長的機會。

  • We're not banking in significant changes in epilepsy monitoring unit admissions to the guidance that we provided. So that provides some opportunity for upside if we're able to see that through the year. So just being cautious, if you will, about what's happening within the market overall and understanding that there's a lot that we can and expect that we will do to be able to execute on taking share of patients coming through the EMU, whatever that volume is.

    我們並沒有指望癲癇監測單位入院對我們提供的指導發生重大變化。因此,如果我們能夠在這一年中看到這一點,那將提供一些上漲機會。因此,如果你願意的話,請對整個市場內發生的事情保持謹慎,並了解我們可以做很多事情並期望我們能夠執行以獲取通過 EMU 的患者份額,無論數量是多少.

  • Andrew Christopher Ranieri - Equity Analyst

    Andrew Christopher Ranieri - Equity Analyst

  • Got it. And maybe just two high-level questions, but you're talking about a lot of excitement on the NAUTILUS study and the potential there and generalized epilepsy. So maybe as you're having centers come online, having patients even interested, is it driving at all any halo effect maybe on the focal side as more interest in epilepsy or treating epilepsy through RNS is growing? And then second, just with DIXI, how it's giving you another revenue stream? Do you foresee any additional partnership opportunities in '23 to augment revenue?

    知道了。也許只是兩個高級問題,但你說的是關於 NAUTILUS 研究的很多興奮以及那裡的潛力和廣泛性癲癇。因此,也許當您讓中心上線,甚至讓患者感興趣時,隨著人們對癲癇或通過 RNS 治療癲癇的興趣越來越大,它是否會在焦點方面推動任何光環效應?其次,就 DIXI 而言,它如何為您提供另一個收入來源?您是否預見到 23 年會有任何額外的合作機會來增加收入?

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Yes. Thanks, Drew. I think it's too early to comment on any specifics about halo effect. But I will comment that some of the centers that are participating in the NAUTILUS studies are centers that are not doing a lot of RNS, not doing very much RNS with the focal epilepsy indication.

    是的。謝謝,德魯。我認為現在評論有關光環效應的任何細節還為時過早。但我要評論的是,一些參與 NAUTILUS 研究的中心是沒有做很多 RNS 的中心,沒有做太多針對局灶性癲癇適應症的 RNS。

  • And so that's providing an opportunity for us to have more touch time with them, talking about the RNS system and the benefit that's there. I do think there is some halo effect back to the already approved indication within those centers. And so I think that's -- it's all a good thing for us to have more talk points and more touch points with a broader set of clinicians talking about and patients talking about the benefit of response neuromodulation.

    因此,這為我們提供了一個機會,讓我們有更多時間與他們接觸,討論 RNS 系統及其帶來的好處。我確實認為這些中心已經批准的適應症有一些光環效應。所以我認為這對我們來說是一件好事,與更廣泛的臨床醫生談論和患者談論反應神經調節的好處有更多的談話點和更多的接觸點。

  • As we think about the impact of the DIXI Medical revenue and where there could be other opportunities, I'm not going to comment on that specifically. We do have a top-end sales organization selling now DIXI product as well as the RNS system in the U.S., and we'll be always creatively looking for how can we'd be able to make the most of it, but nothing specific that I would comment on for 2023.

    當我們考慮 DIXI Medical 收入的影響以及可能存在其他機會的地方時,我不打算對此發表具體評論。我們確實有一個高端銷售組織現在在美國銷售 DIXI 產品和 RNS 系統,我們將一直創造性地尋找我們如何能夠充分利用它,但沒有具體說明我會評論 2023 年。

  • Operator

    Operator

  • And I am showing no further questions. I would now like to turn the call back over to Mike for closing remarks.

    我不再提出更多問題。我現在想將電話轉回 Mike 以作結束語。

  • Michael L. Favet - President, CEO & Director

    Michael L. Favet - President, CEO & Director

  • Great. Thank you all for your participation today. I look forward to talking to you again on our Q1 earnings or at upcoming investor conferences. Have a good evening.

    偉大的。感謝大家今天的參與。我期待著在我們的第一季度收益或即將舉行的投資者會議上再次與您交談。晚上好。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating. You may now disconnect.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。