Clearpoint Neuro Inc (CLPT) 2022 Q4 法說會逐字稿

Greetings, and welcome to the ClearPoint Neuro Fourth Quarter and Full Year 2022 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎來到 ClearPoint Neuro 第四季度和 2022 年全年財務業績電話會議。 （操作員說明）提醒一下，正在錄製此會議。

Comments made on this call may include statements that are forward-looking within the meaning of securities laws. These forward-looking statements may include, without limitation, statements related to anticipated industry trends; the company's plans, prospects and strategies, both preliminary and projected; the size of total addressable markets or the market opportunity for the company's products and services and management's expectations, beliefs, estimates or projections regarding future results of operations. Actual results or trends could differ materially. The company undertakes no obligation to revise forward-looking statements for new information or future events. For more information, please refer to the company's annual report on Form 10-K for the year ended December 31, 2021, and the company's quarterly report on Form 10-Q for the 3 months ended September 30, 2022, both of which have been filed with the Securities and Exchange Commission and the company's annual report on Form 10-K for the year ended December 31, 2022, which the company intends to file with the Securities and Exchange Commission on or before March 31, 2023. All of the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com.

對此次電話會議的評論可能包括證券法意義上的前瞻性陳述。這些前瞻性陳述可能包括但不限於與預期行業趨勢相關的陳述；公司的計劃、前景和戰略，包括初步的和預計的；公司產品和服務的總潛在市場規模或市場機會，以及管理層對未來經營業績的預期、信念、估計或預測。實際結果或趨勢可能存在重大差異。公司不承擔為新信息或未來事件修改前瞻性陳述的義務。欲了解更多信息，請參閱公司截至 2021 年 12 月 31 日止年度的 10-K 表年度報告和公司截至 2022 年 9 月 30 日止三個月的 10-Q 表季度報告，兩者均已向美國證券交易委員會提交了公司截至 2022 年 12 月 31 日止年度的 10-K 表格年度報告，該公司打算在 2023 年 3 月 31 日或之前向美國證券交易委員會提交該報告。公司的所有備案文件可從 SEC 或公司網站 www.clearpointneuro.com 獲取。

I will now turn the call over to Joe Burnett, Chief Executive Officer.

我現在將把電話轉給首席執行官喬伯內特。

Thank you, Maria, and thank you to all of the investors and analysts on today's call for being a part of the ClearPoint vision and journey. Our mission and our priority is to help restore quality of life to patients and their families who are suffering from some of the most debilitating neurological disorders imaginable.

謝謝 Maria，也感謝所有投資者和分析師在今天的電話會議上成為 ClearPoint 願景和旅程的一部分。我們的使命和首要任務是幫助患有一些可以想像到的最令人虛弱的神經系統疾病的患者及其家人恢復生活質量。

In the fourth quarter and full year 2022 and we have continued to make progress across our 4-pillar growth strategy, including biologics and drug delivery, functional neurosurgery navigation, therapy and access products and in achieving global scale. We are excited to continue this momentum into 2023, where we again expect more than 20% growth and further progress in all 4 of those same growth pillars.

在第四季度和 2022 年全年，我們在四大支柱增長戰略中繼續取得進展，包括生物製劑和藥物輸送、功能性神經外科導航、治療和准入產品，並實現全球規模。我們很高興能將這種勢頭延續到 2023 年，我們再次預計增長將超過 20%，並在所有 4 個相同的增長支柱上取得進一步進展。

I will now turn the call over to Danilo D’Alessandro, our CFO, to review our financial performance in the fourth quarter and full year 2022, after which I will add some additional detail to our 4-pillar growth strategy moving forward. Danilo?

我現在將電話轉給我們的首席財務官 Danilo D'Alessandro，以審查我們在第四季度和 2022 年全年的財務業績，之後我將為我們的四大支柱增長戰略添加一些額外的細節。達尼洛？

Thank you, Joe, and thank you all for joining us today.

謝謝你，喬，感謝大家今天加入我們。

Let me start by looking at the full year 2022 results. ClearPoint Neuro total revenues were $20.6 million for the year ended December 31, 2022, which represents a 26% increase over revenue of $16.3 million in 2021. Our revenue is made up of 3 components: functional neurosurgery navigation and therapy, biologics and drug delivery and capital equipment and software. Functional neurosurgery navigation revenue consists of commercial sales of disposable products and services related to cases utilizing the ClearPoint system to deliver medical device therapy to the intended target. This revenue segment increased 13% to $9.1 million for the year 2022, up from $8.1 million in 2021.

讓我先看看 2022 年的全年業績。 ClearPoint Neuro 截至 2022 年 12 月 31 日止年度的總收入為 2060 萬美元，比 2021 年的 1630 萬美元增長了 26%。我們的收入由三個部分組成：功能性神經外科導航和治療、生物製劑和藥物輸送以及資本設備和軟件。功能性神經外科導航收入包括與使用 ClearPoint 系統向預期目標提供醫療設備治療的病例相關的一次性產品和服務的商業銷售。該收入部分在 2022 年增長了 13%，達到 910 萬美元，高於 2021 年的 810 萬美元。

Biologics and drug delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products. Biologics and drug delivery revenue increased 34% to $9.1 million in 2022, up from $6.8 million in 2021. This increase was due to both an increase in commitments by our current partners and new pharmaceutical partners.

生物製劑和藥物交付收入包括一次性產品的銷售和與客戶贊助的使用我們產品的臨床前和臨床試驗相關的服務。到 2022 年，生物製品和藥物輸送收入增長了 34%，達到 910 萬美元，高於 2021 年的 680 萬美元。這一增長是由於我們現有合作夥伴和新製藥合作夥伴的承諾增加所致。

Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and of related services was $2.3 million for the year 2022, a 61% increase compared to 2021.

2022 年的資本設備和軟件收入（包括 ClearPoint 可重複使用的硬件和軟件以及相關服務的銷售額）為 230 萬美元，比 2021 年增長 61%。

Gross margin for the full year 2022 was 66% compared to 68% in 2021. This decrease was due primarily to an increase in indirect labor costs in 2022 as compared to 2021 as well as an increase in excess and obsolete inventory reserves. Research and development costs were $10.9 million for the year 2022 compared to $9.3 million in 2021, an increase of $1.6 million or 17%. The increase was due primarily to increases in personnel costs, including share-based compensation expense of $1.4 million due to growth in headcount and a $0.1 million increase in regulatory fees.

2022 年全年的毛利率為 66%，而 2021 年為 68%。下降的主要原因是 2022 年的間接勞動力成本較 2021 年有所增加，以及過剩和過時庫存儲備增加。 2022 年的研發成本為 1090 萬美元，而 2021 年為 930 萬美元，增加了 160 萬美元或 17%。增加的主要原因是人員成本的增加，包括因員工人數增加而產生的 140 萬美元的股權補償費用和 10 萬美元的監管費用增加。

Sales and marketing expenses were $9.4 million for the year 2022 compared to $7.2 million in 2021, an increase of $2.1 million or 30%. This increase was primarily due to increases in personnel costs, including share-based compensation expense of $1.5 million, resulting from increase in headcount in our clinical and marketing teams, increases in travel expenses of $0.3 million and increases in marketing activities of $0.2 million.

2022 年的銷售和營銷費用為 940 萬美元，而 2021 年為 720 萬美元，增加了 210 萬美元或 30%。這一增長主要是由於人事成本的增加，包括 150 萬美元的股份補償費用，這是由於我們的臨床和營銷團隊人數增加，差旅費用增加 30 萬美元，營銷活動增加 20 萬美元。

General and administrative expenses were $9.6 million for the year 2022 compared to $8 million in 2021, an increase of $1.6 million or 20%. This increase was due primarily to increases in personnel costs and share-based compensation of $1.5 million; IT costs of $0.3 million, insurance costs of $0.2 million, offset by a decrease in bad debt expense of $0.3 million.

2022 年的一般和行政費用為 960 萬美元，而 2021 年為 800 萬美元，增加了 160 萬美元或 20%。這一增長主要是由於人事成本和基於股份的薪酬增加 150 萬美元； IT 成本為 30 萬美元，保險成本為 20 萬美元，被壞賬費用減少 30 萬美元所抵消。

Net interest expense for the year 2022 was $0.1 million compared to $1 million in 2021 due to the conversion into equity of 2 tranches of convertible debt in May 2021 and November 2021. Additionally, interest expense was partially offset by higher interest income in 2022 as a result of the increasing interest rates and the company's investment in U.S. government debt securities.

2022 年的淨利息支出為 10 萬美元，而 2021 年為 100 萬美元，原因是 2 批可轉換債券在 2021 年 5 月和 2021 年 11 月轉換為股權。此外，利息支出被 2022 年較高的利息收入部分抵消，因為利率上升和公司對美國政府債務證券投資的結果。

I will now turn to the fourth quarter 2022 results. Total revenues were $5.2 million for the 3 months ended December 31, 2022, an increase of 21% over $4.3 million in the fourth quarter of 2021. Functional neurosurgery and therapy revenue increased 7% to $2.3 million for the fourth quarter of 2022 from $2.1 million for the same period in 2021.

我現在將轉向 2022 年第四季度的結果。截至 2022 年 12 月 31 日止三個月的總收入為 520 萬美元，比 2021 年第四季度的 430 萬美元增長 21%。功能性神經外科和治療收入從 210 萬美元增長 7% 至 2022 年第四季度的 230 萬美元2021 年同期。

Biologics and drug delivery revenue increased 37% and to $2.3 million in the fourth quarter of 2022 from $1.7 million in the same period in 2021. The increase was predominantly due to a 79% increase in biologics and drug delivery service revenue partially offset by a slight decrease in product revenue. Capital equipment product and related service revenue increased 25% to $0.6 million for the fourth quarter of 2022, as compared with $0.5 million in the same period of 2021 due to an increase in the placement of ClearPoint capital and software.

生物製劑和藥物輸送收入從 2021 年同期的 170 萬美元增長 37% 到 2022 年第四季度的 230 萬美元。增長的主要原因是生物製劑和藥物輸送服務收入增長 79%，部分被輕微的增長所抵消產品收入減少。 2022 年第四季度，資本設備產品及相關服務收入增長 25% 至 60 萬美元，而 2021 年同期為 50 萬美元，原因是 ClearPoint 資本和軟件的配售增加。

Gross margin was 64% for the fourth quarter of 2022 compared to a gross margin of 77% for the fourth -- for the same period in 2021. The decrease in gross margin was due primarily to higher overhead expenses and inventory reserves. Operating expenses for the fourth quarter of 2022 were $7.8 million compared to $7.3 million for the fourth quarter of 2021. The increase was mainly driven by the increase in headcount across the organization and share-based compensation. The fourth quarter operating expenses include a onetime year-to-date reclassification of $1.9 million to classify share-based compensation in the same income statement line items as the cash compensation paid to those employees rather than in general and administrative expense.

2022 年第四季度的毛利率為 64%，而 2021 年第四季度的毛利率為 77%。毛利率下降的主要原因是間接費用和存貨儲備增加。 2022 年第四季度的運營費用為 780 萬美元，而 2021 年第四季度為 730 萬美元。增長的主要原因是整個組織的員工人數增加和基於股份的薪酬。第四季度的運營費用包括年初至今的 190 萬美元的一次性重新分類，將基於股份的薪酬分類在與支付給這些員工的現金薪酬相同的損益表項目中，而不是在一般和管理費用中。

With respect to our cash position at the end of December 2022, we held cash, cash equivalents and short-term investment balances of $37.5 million compared to $54.1 million at the end of 2021. Our cash decrease resulted primarily from our operating cash needs. Net cash flows used in operating activities for the year ended 2022 were $16.2 million, an increase of $3.5 million from the year ended 2021. The increase in operating cash need was primarily driven by $4.4 million in additional inventory purchases to mitigate any risk to our supply chain.

關於我們在 2022 年 12 月末的現金頭寸，我們持有現金、現金等價物和短期投資餘額為 3750 萬美元，而 2021 年底為 5410 萬美元。我們的現金減少主要是由於我們的運營現金需求。截至 2022 年，用於經營活動的現金流量淨額為 1620 萬美元，比 2021 年底增加 350 萬美元。經營現金需求的增加主要是由於額外購買了 440 萬美元的庫存，以減輕我們供應的任何風險鏈。

In the fourth quarter, our cash burn was approximately $3 million, the lowest quarterly cash burn since Q1 2021.

第四季度，我們的現金消耗約為 300 萬美元，是自 2021 年第一季度以來最低的季度現金消耗。

I'd like to turn the call back to Joe.

我想把電話轉回給喬。

Thanks, Danilo. 2022 was a successful year for our team across our 4-pillar growth strategy, which has remained in place for the past 5 years and headlined by record revenue of $20.6 million and 26% growth.

謝謝，達尼洛。 2022 年是我們團隊在四大支柱增長戰略中取得成功的一年，該戰略在過去 5 年中一直保持不變，並以創紀錄的 2060 萬美元收入和 26% 的增長率為標題。

Over the past 2 years, we have solidified our leadership team with amazing hires and operations, finance, legal, quality, regulatory, preclinical and clinical research using the funds available from our capital raise back in early as 2021. We now have the foundation to drive scale and productivity with the expectation that sales will start to outpace expense growth in the years ahead.

在過去的 2 年中，我們利用早在 2021 年就籌集的資金提供的資金，通過出色的招聘和運營、財務、法律、質量、監管、臨床前和臨床研究鞏固了我們的領導團隊。我們現在有了基礎推動規模和生產力，預計未來幾年銷售額將開始超過費用增長。

Now let's break that progress down into our 4 growth pillars. First, our biologics and drug delivery team continued to add new pharma partners and services throughout 2022. At present, we currently have more than 50 active partners in this space and have been able to maintain the pace of approximately one new partner added each month. We continue to expect that biologics and drug delivery will be one of our fastest-growing segments as we have prepared for growth along 3 major axes.

現在讓我們將這一進展分解為我們的 4 個增長支柱。首先，我們的生物製劑和藥物交付團隊在整個 2022 年繼續增加新的製藥合作夥伴和服務。目前，我們目前在該領域擁有 50 多個活躍合作夥伴，並且能夠保持每月大約增加一個新合作夥伴的速度。我們繼續預計生物製劑和藥物輸送將成為我們增長最快的領域之一，因為我們已經為三大軸的增長做好了準備。

First, we will continue to add new partners in 2023 as we have not yet achieved even 50% of the partnerships where we believe our technology can help their platform. Second, we continue to add new services, expanding the menu of available projects that our team has the capability to provide to these partners. And third, we expect the majority of our partners to continue to progress through the regulatory pathway from bench to preclinical and eventually clinical trial and commercialization. At present, we do expect the initiation of multiple clinical trials through our partnerships this calendar year.

首先，我們將在 2023 年繼續增加新的合作夥伴，因為我們還沒有實現我們認為我們的技術可以幫助他們平台的合作夥伴中的 50%。其次，我們繼續添加新服務，擴展我們團隊有能力為這些合作夥伴提供的可用項目菜單。第三，我們希望我們的大多數合作夥伴繼續通過從實驗室到臨床前、最終臨床試驗和商業化的監管途徑取得進展。目前，我們確實希望在本日曆年通過我們的合作夥伴關係啟動多項臨床試驗。

Now as a reminder, if one partner were to use ClearPoint for our entire portfolio of products and services, that represents approximately an $8 million to $10 million in revenue potential over a 5-year period. Multiply that opportunity times our 50-plus partners and that is potentially a few hundred million in addressable market before any drug product is even commercialized. This is a primary driver as to why we feel our company can achieve cash breakeven without the requirement of any meaningful revenue from approved and commercialized drugs.

現在提醒一下，如果一個合作夥伴將 ClearPoint 用於我們的整個產品和服務組合，那麼這意味著在 5 年期間大約有 800 萬到 1000 萬美元的收入潛力。將這個機會乘以我們的 50 多個合作夥伴，在任何藥品商業化之前，潛在市場就可能達到數億美元。這是我們認為我們公司無需從已批准和商業化的藥物中獲得任何有意義的收入就可以實現現金收支平衡的主要驅動力。

Speaking of commercialization, our team achieved a very significant milestone in 2022 in the co-labeling in Europe for our SmartFlow cannula with the very first neuro gene therapy approved anywhere in the world, Upstaza, made by PTC Therapeutics. The approved labeling of this drug includes the requirement of using our cannula when dosing patients and is the result of robust preclinical and clinical testing data that continues to be collected today.

說到商業化，我們的團隊在 2022 年實現了一個非常重要的里程碑，即我們的 SmartFlow 插管在歐洲的聯合標記，這是世界上任何地方都批准的第一個神經基因療法，由 PTC Therapeutics 製造的 Upstaza。該藥物的批准標籤包括在給患者給藥時使用我們的插管的要求，並且是今天繼續收集的可靠的臨床前和臨床測試數據的結果。

While commercialization of other drugs will take some time, I cannot stress the importance and the potential if many, if not all, of our partners eventually achieve regulatory clearance with similar co-labeling with our devices.

雖然其他藥物的商業化需要一些時間，但如果我們的許多（如果不是全部）合作夥伴最終通過與我們的設備進行類似的共同標記獲得監管許可，我無法強調其重要性和潛力。

For our second pillar of growth, let's now turn to functional neurosurgery navigation. Many of the challenges we saw in 2020 and 2021 persisted into 2022, contributing to an elevated cancellation and postponement rate for elective procedures, including flu and COVID infections, staffing shortages and supply chain issues contributing to equipment back orders and delayed repairs. Now while we invested in additional inventory and did not experience any substantial supply shortages, we are still only the navigation portion of the procedure and a backorder for another company's therapy product can also contribute to a cancellation for a ClearPoint procedure.

對於我們的第二個增長支柱，現在讓我們轉向功能性神經外科導航。我們在 2020 年和 2021 年看到的許多挑戰一直持續到 2022 年，導致擇期手術的取消和推遲率升高，包括流感和 COVID 感染、人員短缺和供應鏈問題，導致設備延期交貨和維修延遲。現在，雖然我們投資了額外的庫存並且沒有遇到任何實質性的供應短缺，但我們仍然只是程序的導航部分，而另一家公司的治療產品的延期交貨也可能導致取消 ClearPoint 程序。

That being said, we still see strong demand for our navigation products where we placed a record 11 new systems in 2022. In fact, here in 2023, we have already installed 3 systems year-to-date and believe we will place a total of at least 10 systems this calendar year keeping us on track to achieve 100 systems by 2025. And when we do perform an installation, new sites are getting a much more advanced solution in 2023 as we achieved multiple FDA clearances for new hardware and software, including ClearPoint version 2.2 software, Array version 1.1 software, Maestro segmentation tools, inflection head frames and more.

話雖如此，我們仍然看到對我們的導航產品的強勁需求，我們在 2022 年安裝了創紀錄的 11 個新系統。事實上，到 2023 年，我們今年迄今已經安裝了 3 個系統，並且相信我們將總共安裝本日曆年至少有 10 個系統，這使我們有望在 2025 年之前實現 100 個系統。當我們執行安裝時，新站點將在 2023 年獲得更先進的解決方案，因為我們獲得了對新硬件和軟件的多項 FDA 許可，包括ClearPoint 2.2 版軟件、Array 1.1 版軟件、Maestro 分割工具、彎曲頭架等。

A first experience with ClearPoint today is very different than years ago. The ability to accelerate to 2 procedures a day is driving our surgical efficiency faster than ever. We expect additional submissions and potential clearances this year in 2023 and believe with the size of our software and data scientist teams that we can deliver a cadence of at least one new software release each year for the foreseeable future. We also expect FDA submission in 2023 for 2 additional hardware offerings, including our Orchestra head fixation frame and the SmartFrame Cortex, which will be used for the implantation of brain computer interfaces to the cortical surface of the brain, primarily in clinical trial.

今天對 ClearPoint 的初次體驗與幾年前大不相同。每天可以加速到 2 次手術的能力比以往任何時候都更快地提高了我們的手術效率。我們預計今年到 2023 年會有更多的提交和潛在的許可，並且相信憑藉我們的軟件和數據科學家團隊的規模，我們可以在可預見的未來每年至少發布一個新軟件版本。我們還預計 FDA 將在 2023 年提交 2 種額外的硬件產品，包括我們的 Orchestra 頭部固定框架和 SmartFrame Cortex，它們將用於將大腦計算機接口植入大腦皮質表面，主要用於臨床試驗。

For pillar #3, therapy and access devices, we achieved a major milestone in 2022 with the FDA clearance of the Prism Laser Therapy System marking the first therapy product in our portfolio. Initial experience with Prism has been positive with early cases now performed in the United States and in Europe. We expect to remain in a limited market release with relatively modest revenue in 2023, while we continue to gain experience with the product and prepare marketing and training materials to highlight the advantages of the Prism Laser System. We then expect to move to a full market release in 2024 after receiving FDA clearance for the 1.5 Tesla scanner labeling to our product.

對於支柱#3、治療和接入設備，我們在 2022 年實現了一個重要的里程碑，棱鏡激光治療系統獲得 FDA 批准，標誌著我們產品組合中的第一個治療產品。 Prism 的初步經驗是積極的，早期病例現在在美國和歐洲進行。我們預計到 2023 年將保持有限的市場發布，收入相對適中，同時我們將繼續獲得該產品的經驗並準備營銷和培訓材料，以突出 Prism 激光系統的優勢。然後，我們預計在獲得 FDA 對我們產品的 1.5 特斯拉掃描儀標籤的許可後，將在 2024 年全面上市。

Finally, our fourth pillar of growth, achieving global scale, has made great progress as well. As previously mentioned, we have signed a lease for a new 20,000 square foot manufacturing and development facility in Carlsbad, California, where we expect to be fully operational and producing product by the end of 2023. This facility will serve as a product showcase for pharma partners, will be designed for improved product and manufacturing flow and eventually margin improvements in the years ahead. We believe the capacity of the site will support the next 5 to 10 years of growth from a production standpoint in addition to adding new testing and preclinical services to support our 50-plus pharma partners.

最後，我們的第四個增長支柱，即實現全球規模，也取得了長足進步。如前所述，我們已在加利福尼亞州卡爾斯巴德簽署了一個佔地 20,000 平方英尺的新製造和開發設施的租約，我們預計到 2023 年底，該設施將全面投入運營並生產產品。該設施將作為製藥公司的產品展示合作夥伴，將旨在改進產品和製造流程，並最終在未來幾年提高利潤率。我們相信，除了增加新的測試和臨床前服務以支持我們 50 多家製藥合作夥伴之外，該站點的容量還將支持未來 5 到 10 年的生產增長。

Our expansion outside the United States has continued with a total of 10 OUS sites now installed and ready to do cases. In 2023, we expect between 50 and 100 cases will be performed in non-U.S. hospitals, which again is crucial for winning contracts with pharma partners outside the U.S. that want to run clinical trials on their home field.

我們在美國以外的擴張仍在繼續，目前共有 10 個 OUS 站點已安裝並準備好處理案例。到 2023 年，我們預計將有 50 到 100 例病例在美國以外的醫院進行，這對於贏得與希望在其本土領域進行臨床試驗的美國境外製藥合作夥伴的合同同樣至關重要。

For 2023, we continue to expect revenue in the range of $25 million to $27 million for the year, representing growth between 21% and 31% year-over-year. Revenue in Q1 will likely be in the range of $5 million to $5.5 million and subsequent quarters growing more rapidly based on our capital sales pipeline, laser therapy revenue and timing of preclinical services, which are going to contribute more in the second half of 2023.

對於 2023 年，我們繼續預計全年收入在 2500 萬美元至 2700 萬美元之間，同比增長 21% 至 31%。根據我們的資本銷售管道、激光治療收入和臨床前服務的時間安排，第一季度的收入可能在 500 萬至 550 萬美元之間，隨後幾個季度的收入增長更快，這些收入將在 2023 年下半年做出更多貢獻。

From a cash standpoint, Danilo mentioned, we ended the year at $37.5 million in cash and short-term investments. Based on our current projections, we expect our operational cash burn in 2023 to improve slightly compared to 2022 as we see an inflection point more in 2024, where revenue will outpace expenses and our new manufacturing facility will be up and running.

Danilo 提到，從現金的角度來看，我們年底的現金和短期投資為 3750 萬美元。根據我們目前的預測，我們預計 2023 年的運營現金消耗將比 2022 年略有改善，因為我們在 2024 年看到了更多的拐點，屆時收入將超過支出，我們的新製造工廠將投入運營。

In the near term, similar to 2022, we expect a comparable cash flow seasonality of a larger cash burn in the first half of 2023 when onetime annual expenses like bonuses, corporate fees and insurance are paid, followed by a slower cash burn in the second half of 2023. As we look at timing for what cash breakeven looks like for the company, we have run a number of scenarios. Based on our current projections, we feel that as a company, we can achieve cash breakeven when we get to the milestone of 50 hospitals each doing 50 cases a year or on average, one case per week at these 50 centers of excellence. This combined with capital sales and service assumption at those 50 hospitals, and modest growth in our preclinical services would deliver approximately $50 million in revenue and support operational cash breakeven.

在短期內，與 2022 年類似，我們預計 2023 年上半年會出現較大的現金流量季節性，屆時一次性支付獎金、公司費用和保險等年度費用，隨後在下半年現金消耗放緩2023 年下半年。當我們考慮公司現金收支平衡的時間時，我們運行了多種情景。根據我們目前的預測，我們認為，作為一家公司，當我們達到 50 家醫院每家每年處理 50 個病例或平均每週在這 50 個卓越中心處理一個病例的里程碑時，我們可以實現現金收支平衡。這與這 50 家醫院的資本銷售和服務假設相結合，以及我們臨床前服務的適度增長將帶來大約 5000 萬美元的收入並支持運營現金收支平衡。

The good news is that we're already installed at approximately 70 centers around the world and will add approximately 10 additional this year so that we have the installed base to support this next phase as our portfolio fills out. At a single hospital, if we can get 30 DBS cases a year, 15 laser cases a year and 5 biologics and drug delivery clinical trial patients each year, then that is a credible path to the volume we need to achieve. Again, this would require only one day a week of MRI or operating room time, which is reasonable and can be supported by the portfolio of products that we can certain to have -- that we expect to have available by 2025.

好消息是，我們已經在全球大約 70 個中心安裝了設備，今年還將增加大約 10 個，這樣我們就有了安裝基礎來支持下一階段的產品組合。在一家醫院，如果我們每年可以獲得 30 個 DBS 病例、15 個激光病例和 5 個生物製劑和藥物輸送臨床試驗患者，那麼這是我們需要達到的數量的可靠途徑。同樣，這只需要每週進行一天的 MRI 或手術室時間，這是合理的，並且可以得到我們可以肯定擁有的產品組合的支持——我們預計到 2025 年可以使用這些產品組合。

Our internal projections and expectations support us achieving an operational cash breakeven by the fourth quarter of 2025 and a full year cash breakeven in 2026 if our strategy holds and barring any significant disruptions to patient demand, inorganic investments or delays to our planned product launches. We believe to have line of sight to this milestone and importantly, don't need massive patient demand increases or even commercial approval of large gene and cell therapy indications in that time frame.

我們的內部預測和預期支持我們在 2025 年第四季度實現運營現金盈虧平衡，並在 2026 年實現全年現金盈虧平衡，前提是我們的戰略保持不變，並且不會對患者需求、無機投資造成任何重大干擾或延遲我們計劃的產品發布。我們相信對這一里程碑有一定的了解，重要的是，在那個時間框架內不需要大量的患者需求增加，甚至不需要對大基因和細胞治療適應症進行商業批准。

With that, I would like to open up the call to any questions that you might have.

有了這個，我想打開你可能有的任何問題的電話。

(Operator Instructions) Our first question is from Frank Takkinen with Lake Street Capital Markets.

（操作員說明）我們的第一個問題來自 Lake Street Capital Markets 的 Frank Takkinen。

I wanted to start with one on the comment about multiple clinical trials likely to launch at some point this year. Maybe talk a little bit more through those and how it relates to the total revenue potential of a partner in what stage those clinical trials may be in and how that could affect the model as we look at 2023?

我想從關於今年某個時候可能啟動的多項臨床試驗的評論開始。也許通過這些多談一點，以及它與合作夥伴的總收入潛力有何關係，這些臨床試驗可能處於什麼階段，以及這將如何影響我們對 2023 年的模型？

Sure. Yes. Thanks for the question, Frank. Yes, so if you think about 2023 and some of the trials that our partners have communicated the schedules for to us and again, we're going to keep who the partners are confidential, just to make sure we're respecting our agreements that we have. But what I can tell you is that some of these trials will start -- will continue, I would say, in the rare childhood genetic range of things, which as we've seen with our partner, PTC, often requires a less rigorous clinical trial protocol, meaning that you can follow a BLA process and submit data without necessarily a pivotal study or a randomized sham-controlled study or something like that. So we do expect some of those to start here in 2023.

當然。是的。謝謝你的問題，弗蘭克。是的，所以如果你想到 2023 年以及我們的合作夥伴已經向我們傳達了時間表的一些試驗，我們將為合作夥伴保密，只是為了確保我們尊重我們的協議有。但我可以告訴你的是，其中一些試驗將開始——我會說，將繼續在罕見的兒童遺傳範圍內進行，正如我們在我們的合作夥伴 PTC 身上看到的那樣，通常需要不那麼嚴格的臨床試驗試驗方案，這意味著您可以遵循 BLA 流程並提交數據，而不必進行關鍵研究或隨機假對照研究或類似的研究。因此，我們確實希望其中一些能夠在 2023 年從這裡開始。

However, we also expect the initiation of much larger potential indications for studies like Parkinson's disease and more adult disorders, which will include a longer clinical trial pathway. However, it will also include a larger number of patients that need to be enrolled to show that. I think as we've discussed in the past, some of the Phase II and Phase III trial design that we've seen in the past to show full efficacy and be required by the FDA, could include as many as 200 patients in those trials. And in some of these particular studies, we can contribute anywhere from $10,000 to even $20,000 or more per patient. So an individual clinical trial that's probably run over a couple of years, could contribute anywhere from $2 million to $4 million just with one of those pivotal trials.

然而，我們也期望啟動更大的潛在適應症研究，如帕金森病和更多成人疾病，這將包括更長的臨床試驗途徑。然而，它也將包括更多需要登記的患者來證明這一點。我認為正如我們過去所討論的那樣，我們過去看到的一些 II 期和 III 期試驗設計顯示出全部療效並被 FDA 要求，這些試驗可能包括多達 200 名患者.在其中一些特定研究中，我們可以為每位患者捐助 10,000 美元到 20,000 美元或更多。因此，一項可能運行了幾年的個人臨床試驗，僅通過其中一項關鍵試驗就可以貢獻 200 萬至 400 萬美元。

So we do expect the initiation of hopefully a couple of those larger indications to happen sometime in 2023.

因此，我們確實希望在 2023 年的某個時候啟動一些更大的適應症。

And as a follow-up directly to that, how much of that is baked into the guide right now where would one of those trials kicking off in 2023 be upside to the guidance?

作為直接的後續行動，現在指南中包含了多少內容，而 2023 年開始的其中一項試驗是否會超出指南？

I would say that we have very little in the guidance at this point. I mean our guidance is a range, right? So we've said $25 million to $27 million. So I would say the high end of the range would include more patients being enrolled. But at the low end of the range, I'd say it's very small. It's almost like the assumption that a few patients will be enrolled by the end of the year for some of these trials. So it's really not meaningful and does prevent some upside.

我想說我們在這一點上的指導很少。我的意思是我們的指導是一個範圍，對嗎？所以我們說的是 2500 萬到 2700 萬美元。所以我想說範圍的高端將包括更多的患者被登記。但在範圍的低端，我會說它非常小。這幾乎就像假設一些患者將在年底前被納入其中一些試驗。所以它真的沒有意義，並且確實阻止了一些上行空間。

Okay. That's helpful. And then I wanted to shift over to the laser. Curious how many centers you have tested that laser in the initial commercial launch at this point? And how has the feedback been versus the competing lasers on the market?

好的。這很有幫助。然後我想轉向激光。想知道您在此時的初始商業發布中測試了多少個中心？與市場上的競爭激光器相比，反饋如何？

Yes. I would say the feedback has been very strong. Most of the patients that have been enrolled -- I don't want to say enrolled so far that have been treated so far have been done in a clinical trial protocol in Europe and this has been focused primarily on tumor patients or really exclusively on tumor patients today. Those cases that have been performed there, the device has performed exceptionally well. We're very, very pleased with the results. And as I said in my statements, we are using this time to sort of prepare additional training and marketing materials because there are some meaningful differences between the products currently on the market and what Prism has to offer.

是的。我會說反饋非常強烈。大多數已經入組的患者——我不想說到目前為止已經入組的患者已經在歐洲的臨床試驗方案中完成了治療，這主要集中在腫瘤患者或真正專門針對腫瘤今天的病人。那些已經在那裡執行的案例，該設備執行得非常好。我們對結果非常非常滿意。正如我在聲明中所說，我們正在利用這段時間來準備額外的培訓和營銷材料，因為目前市場上的產品與 Prism 提供的產品之間存在一些有意義的差異。

In the United States, we've done cases at one center so far in the United States, and we're in the process of installing at multiple additional centers as well. Similar to some of the things that we've talked about in the past, any time you're bringing a new piece of hardware and software into a hospital today, the sort of delays, which aren't even delays anymore, they're becoming expected of getting a new technology approved through IT at a hospital, has just been more complicated than it's ever been before. And those teams don't always meet on a weekly basis, sometimes it's only a monthly basis.

在美國，到目前為止，我們已經在美國的一個中心完成了案例，並且我們也在多個其他中心進行安裝。與我們過去討論過的一些事情類似，今天任何時候你將新的硬件和軟件帶入醫院時，都會出現延誤，甚至不再是延誤，它們是期望在醫院通過 IT 批准一項新技術，這比以往任何時候都更加複雜。這些團隊並不總是每週開會，有時只是每月一次。

So that's something that's -- the pace of installation has been a little slower than we expect, but it's not because people are not interested in trying the product. It's really just going through the hurdles that are a necessary part of getting a new technology into a hospital in 2023.

所以這就是 - 安裝速度比我們預期的要慢一些，但這並不是因為人們對試用該產品不感興趣。它實際上只是在克服障礙，這些障礙是 2023 年將新技術引入醫院的必要部分。

Okay. And then last one for me. It sounded like at the end of 2022 there in the last couple of weeks of 2022, there were some cancellations or postponements at least to 2023. Any update on those?

好的。然後最後一個給我。聽起來好像是在 2022 年底，在 2022 年的最後幾週，有一些取消或推遲至少到 2023 年。這些有什麼更新嗎？

Yes. I mean I think the biggest drivers of that, I would say, the most substantial ones. We're in a couple of buckets. The biggest one just being the timing of some of the preclinical services and the way that we recognize revenue. You noticed in Q4, as Danilo mentioned, our cash burn was only $3 million. And part of the contributor to that is some of our pharma partners that are effectively prepaying for services because they do understand the risk and time lines of certain services being ready. We can't perform a certain test, for example, if we don't get the drug delivered to us. So what we have asked and been successful in asking is that the pharma partners can provide some of the cash upfront. So even if there is a delay, we're not losing our time and energy on it.

是的。我的意思是我認為最大的驅動因素，我會說，最重要的驅動因素。我們在幾個桶裡。最大的一個只是一些臨床前服務的時間安排以及我們確認收入的方式。你在第四季度注意到，正如 Danilo 提到的，我們的現金消耗僅為 300 萬美元。對此做出貢獻的部分原因是我們的一些製藥合作夥伴有效地預付了服務費用，因為他們確實了解某些服務準備就緒的風險和時間表。我們無法進行某項測試，例如，如果我們沒有將藥物交付給我們。因此，我們要求並成功要求的是製藥合作夥伴可以預先提供一些現金。因此，即使有延遲，我們也不會為此浪費時間和精力。

From a revenue standpoint, however, that means we don't always recognize the revenue. And I think that some of the -- those were the primary delays that we saw in Q4 of last year. And just honestly, it's going to be a part of normal. The plan that we have is that across 50 different partners and a number of different programs that there will be some delays. However, there's enough shots on goal in any given quarter that will perform the services to keep the revenue growing. So I think that was one of the primary contributors is and it's something that there's nothing I would say that we lost in 2022 that we don't expect to regain in 2023. So it really is a timing issue.

然而，從收入的角度來看，這意味著我們並不總是確認收入。我認為其中一些 - 這些是我們在去年第四季度看到的主要延遲。老實說，這將成為常態的一部分。我們的計劃是，在 50 個不同的合作夥伴和許多不同的計劃中，會有一些延遲。但是，在任何給定的季度中都有足夠的射門機會執行服務以保持收入增長。所以我認為這是主要貢獻者之一，而且我不會說我們在 2022 年失去了我們不希望在 2023 年重新獲得的東西。所以這確實是一個時間問題。

The other side of the equation is that there were some definite postponements and high cancellation rates, especially around the last few weeks of December, which contributed probably to another $100,000 to $150,000 of case postponements. Again, as we've shared in the past, some of the -- there's good and bad parts of that. The good part is, is that it's very rare that a case is canceled outright. It's normally postponed, whether it's patient is sick or a surgeon is sick or there's a temporary insurance denial that gets sorted out with a new letter from the doctor or something like that.

等式的另一面是，有一些明確的延期和高取消率，尤其是在 12 月的最後幾週左右，這可能導致另外 100,000 至 150,000 美元的案件延期。同樣，正如我們過去分享的那樣，其中一些 - 有好的部分也有壞的部分。好的部分是，案件被徹底取消的情況非常罕見。它通常會被推遲，無論是病人生病還是外科醫生生病，或者臨時拒絕保險，醫生會寫一封新信或類似的東西來解決。

So the good news is that these patients still have a chance to get treated, the challenging part for our current model is that just because it's postponed, it doesn't necessarily mean that there's more MRI access time in the future. So if you still only have that one slot, it takes a little time to recoup and get that patient scheduled. So as we've discussed in the past, a big part of our strategy is evolving out of the MRI and into the operating room which will allow us to recoup some of these postponements faster because we'll have 2 different arenas in which we can treat that patient.

所以好消息是這些患者仍然有機會得到治療，我們當前模型的挑戰性部分在於，僅僅因為它被推遲了，並不一定意味著未來會有更多的 MRI 訪問時間。因此，如果您仍然只有一個空位，則需要一點時間來恢復並安排該患者。因此，正如我們過去所討論的那樣，我們戰略的很大一部分正在從核磁共振成像發展到手術室，這將使我們能夠更快地收回其中一些延期，因為我們將有兩個不同的領域，我們可以治療那個病人。

(Operator Instructions) Our next question comes from Neil Chatterji with B. Riley Securities.

（操作員說明）我們的下一個問題來自 B. Riley Securities 的 Neil Chatterji。

Maybe I think while we're on that topic on the cancellations and postponements. Just if I missed it there on what you said, but in terms of the level or the rates, I think it was recently as high as like say, 30% versus that 8% to 12% historically. So where is that kind of fitting currently?

也許我認為當我們討論關於取消和推遲的話題時。只是如果我錯過了你所說的，但就水平或利率而言，我認為它最近高達 30%，而歷史上為 8% 至 12%。那麼目前這種配件在哪裡呢？

Yes. So the data that we have is we're currently in that 25% to 28% range. I would say if you look back the last rolling 6 months, give or take, and you compare that to a historical number that we had prior to COVID, the COVID initiation, let's call it, that number was in the 10% to 15% range.

是的。所以我們擁有的數據是我們目前處於 25% 到 28% 的範圍內。我想說的是，如果你回顧過去的 6 個月，給予或接受，並將其與我們在 COVID 之前的歷史數字進行比較，我們稱之為 COVID 啟動，該數字在 10% 到 15% 之間範圍。

So effectively, since COVID has come about, for whatever the reason of the cancellations, the impact has totally been pretty much double the cancellation and postponement rate. And we're still seeing some of that persist here in 2023 as well. But that was kind of expected and part of our plan. If you think about the guidance that we provided of $25 million to $27 million, that includes the expectation that this cancellation rate of above 20% is going to persist as well.

如此有效，自從 COVID 出現以來，無論取消的原因是什麼，其影響幾乎是取消和推遲率的兩倍。我們仍然看到其中一些在 2023 年仍然存在。但這是意料之中的，也是我們計劃的一部分。如果您考慮我們提供的 2500 萬至 2700 萬美元的指導，其中包括預計這種超過 20% 的取消率也將持續下去。

Got it. That's helpful color. Great. And then in terms of the -- just on the BDD side, in terms of just conversations with potential new partners, just curious how the success to date you've had with the PTC partnership? Has that helped kind of create the wheels in some of those conversations?

知道了。這是有用的顏色。偉大的。然後就 BDD 方面而言，就與潛在新合作夥伴的對話而言，只是想知道迄今為止您與 PTC 合作夥伴關係取得的成功如何？這是否有助於在其中一些對話中創造輪子？

I think it definitely has. Again, one of the big advantages that we can provide to a pharma partner is the experience with our products being both the navigation and doing these procedures under live MRI guidance, which we certainly believe is the most precise and accurate way to do it. But also the experience that the FDA has with our array of different cannula and drug delivery tools.

我認為肯定有。同樣，我們可以為製藥合作夥伴提供的一大優勢是我們的產品在實時 MRI 指導下進行導航和執行這些程序的體驗，我們當然相信這是最精確和準確的方法。還有 FDA 在我們一系列不同的插管和藥物輸送工具方面的經驗。

And if you -- again, if you're a pharma partner and if you have a chance to get in front of the FDA to present your protocol, I can tell you, in our experience, things go a lot smoother when you're using the SmartFlow cannula because the FDA reviewer can say, Oh, yes, I've approved ClearPoint SmartFlow before I understand this device, it's not simple, but check, let's move on to the next question as opposed to that same pharma company having to say, well, wait a second. This thing is not FDA cleared. We don't have any experience. We've never approved a protocol with this device used before.

如果你 - 再一次，如果你是製藥合作夥伴並且如果你有機會在 FDA 面前展示你的協議，我可以告訴你，根據我們的經驗，當你使用 SmartFlow 插管，因為 FDA 審查員可以說，哦，是的，我在理解這個設備之前就已經批准了 ClearPoint SmartFlow，這並不簡單，但是檢查一下，讓我們繼續下一個問題，而不是同一家製藥公司必須說，好吧，等一下。這件事未經 FDA 批准。我們沒有任何經驗。我們以前從未批准過使用此設備的協議。

If we as a company can help save 3 months or 6 months of negotiation with the FDA that's real time and real money to a pharma partner. And I think that's one of the primary reasons they continue to come and work with us in addition to all the clinical services and things that we provide.

如果我們作為一家公司可以幫助節省 3 個月或 6 個月的與 FDA 的談判時間，這對製藥合作夥伴來說就是實時和真實的金錢。我認為這是除了我們提供的所有臨床服務和事物之外，他們繼續與我們合作的主要原因之一。

And to answer your question, the fact that PTC has now been successful in getting a drug approved in Europe, and it's approved as a combination device. That is definitely another feather that we can put in our hat to say, Hey, we're the one device that's been able to navigate one of these regulatory pathways. And if it can happen here in the United States under FDA clearance as well, I think that will be another significant milestone and very significant marketing tool that we'll be able to use.

為了回答您的問題，事實上 PTC 現在已經成功地在歐洲獲得了一種藥物的批准，並且它被批准為一種組合設備。這絕對是我們可以戴上帽子說的另一根羽毛，嘿，我們是能夠駕馭這些監管途徑之一的設備。如果它也能在美國通過 FDA 許可發生，我認為這將是另一個重要的里程碑，也是我們能夠使用的非常重要的營銷工具。

Got it. Great. And then just one question on just in terms of the guidance for '23. Just kind of curious if there's any way to add any color in terms of just parsing out the different segments. So how do we think about the growth for BDD, functional neuro, capital software in '23?

知道了。偉大的。然後就 23 年的指南提出一個問題。只是有點好奇是否有任何方法可以通過解析不同的段來添加任何顏色。那麼我們如何看待 23 年 BDD、功能神經、資本軟件的增長？

Yes, it's interesting. There's a lot of moving parts on timing and things like that. But when we look at our model and what gave us confidence in providing that range, it really includes all 3 of those different buckets that Danilo presented experiencing growth.

是的，這很有趣。在時間安排等方面有很多變化的部分。但是，當我們審視我們的模型以及是什麼讓我們有信心提供該範圍時，它實際上包括 Danilo 提出的所有 3 個不同的增長桶。

So if you think biologics and drug delivery, as far as a magnitude of gross dollars, don't think about a percentage but an actual growth magnitude. We do expect that to be the largest growth contributor based on POs that we've already received and capabilities that we can now offer. So I think that will still be the highlight one. However, we also do expect our functional neurosurgery and therapy business as well as our capital business to certainly grow in that 15% to 20% plus range as well. So we do expect all 3 buckets to be contributing to growth this year.

因此，如果你認為生物製劑和藥物輸送，就總美元的數量而言，不要考慮百分比，而是實際的增長幅度。根據我們已經收到的 PO 和我們現在可以提供的功能，我們確實希望它成為最大的增長貢獻者。所以我認為這仍然是亮點之一。然而，我們也確實預計我們的功能性神經外科和治療業務以及我們的資本業務也肯定會在 15% 到 20% 以上的範圍內增長。因此，我們確實預計所有 3 個桶都會為今年的增長做出貢獻。

Great. And just one last question for me. So I was just curious if you could just kind of talk a little bit about your international expansion plans and just any updates for Europe or China?

偉大的。最後一個問題問我。所以我很好奇你是否可以談談你的國際擴張計劃以及歐洲或中國的任何更新？

Yes. So I mentioned that we've placed 3 additional systems so far this year in 2023. Actually, all 3 of those happen to be OUS. So 2 of those were placed in Europe. One was placed in Brazil, so our very first installation in South America. And we believe this is an important part now if we were just a neuro navigation company or even a laser therapy company, Brazil is probably not the first country we would go to, for example, right? It's a massive population, but certainly a long ways away from where we are today.

是的。所以我提到我們今年到目前為止在 2023 年已經放置了 3 個額外的系統。實際上，所有這 3 個恰好都是 OUS。所以其中 2 個被放置在歐洲。一個被放置在巴西，所以我們的第一個裝置是在南美洲。我們相信這是一個重要的部分，如果我們只是一家神經導航公司，甚至是一家激光治療公司，巴西可能不是我們要去的第一個國家，例如，對嗎？這是一個龐大的人口，但肯定離我們今天的位置還有很長的路要走。

The support that we get from companies like PTC that have large drug potential sales opportunities in countries like Brazil and Singapore, Taiwan, a bunch of different countries, that is really helping fuel the acceleration and how quickly we would go maybe where if we were just a device company, we'd probably go a little bit slower.

我們從像 PTC 這樣的公司那裡得到的支持，這些公司在巴西和新加坡、台灣等許多不同的國家/地區擁有巨大的潛在藥物銷售機會，這確實有助於推動加速發展，如果我們只是一家設備公司，我們可能會慢一點。

So it's doing 2 things for us. One, it is getting us experience in these new geographies, and that helps drive some of the device business as well because even if we get approval with the goal of treating patients with one of our pharma partners, we're very, very clear that a complicated gene therapy infusion case should not be your first case. So what commonly happens is we say, yes, we're going to do that eventually, but we're going to start on some simple biopsies, DBS procedures, maybe some laser procedures as well to get familiar with the overall system and prepare for these trials down the road. So we get that benefit.

所以它為我們做了兩件事。第一，它讓我們在這些新地區獲得經驗，這也有助於推動一些設備業務，因為即使我們獲得批准的目標是與我們的一家製藥合作夥伴一起治療患者，我們也非常非常清楚一個複雜的基因治療輸液病例不應該是您的第一個病例。所以通常發生的事情是我們說，是的，我們最終會這樣做，但我們將從一些簡單的活檢、DBS 程序開始，也許還有一些激光程序，以熟悉整個系統並為這些試驗在路上。所以我們得到了那個好處。

Secondarily, we get the benefit of putting up additional sort of walls and moats around our company and around our technology. It's very hard to get approval for a cannula, for example, in the United States. It's very hard to get it approved in Europe as well. Many companies that would maybe compete with us in the future might even just stop at those 2 locations. But if we can actually have approval for our devices in a number of different geographies, that's just one more reason that a pharma company should be working with us because we can actually cover a much broader population of the world, which is honestly more how pharma companies think than device companies.

其次，我們受益於在我們的公司和我們的技術周圍豎起額外的圍牆和護城河。例如，在美國很難獲得插管的批准。在歐洲也很難獲得批准。許多未來可能與我們競爭的公司甚至可能會停留在這兩個地方。但是，如果我們的設備實際上可以在多個不同的地區獲得批准，這只是製藥公司應該與我們合作的又一個原因，因為我們實際上可以覆蓋世界上更廣泛的人口，老實說，這更多是製藥公司公司比設備公司思考。

So again, it's a little expensive. It's contributed to some of our cash burn during this regulatory work, et cetera. However, again, it's just like know-how and team hiring and IT investment, this regulatory and quality investment is something that we think is going to protect us in the future.

再說一次，它有點貴。在這項監管工作等方面，它導致了我們的一些現金消耗。然而，同樣，這就像技術訣竅、團隊招聘和 IT 投資一樣，我們認為這種監管和質量投資將在未來保護我們。

There are no further questions at this time. I would now like to turn the floor back over to Joe Burnett for closing comments.

目前沒有其他問題。我現在想把發言權轉回給 Joe Burnett 發表結束評論。

Thank you, Maria. And once again, thank you to everyone interested in being a part of this team's journey here at ClearPoint. We recognize the challenging global environment that we're all forced to live in today, and we assure you that we are going to help patients around the world as best as we possibly can by keeping our heads down, staying focused and executing against our 4-pillar growth strategy to develop products that truly improve the quality of life for our patients and their families.

謝謝你，瑪麗亞。再次感謝所有有興趣參與 ClearPoint 團隊旅程的人。我們認識到當今我們所有人都被迫生活在充滿挑戰的全球環境中，我們向您保證，我們將保持低調、保持專注並針對我們的 4 -支柱增長戰略，開發真正改善患者及其家人生活質量的產品。

Hope you all have a great night. Goodbye.

希望大家度過一個美好的夜晚。再見。

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

今天的會議到此結束。此時您可以斷開線路。感謝您的參與。