Clearpoint Neuro Inc (CLPT) 2022 Q3 法說會逐字稿

Greetings, and welcome to the ClearPoint Neuro, Inc. Third Quarter 2022 Financial Results Conference Call. (Operator Instructions) And as a reminder, this call is being recorded.

您好，歡迎來到 ClearPoint Neuro, Inc. 2022 年第三季度財務業績電話會議。 （操作員說明）作為提醒，此通話正在錄音中。

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 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.

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、公司計劃、前景和戰略（包括初步和預測）以及管理層對未來經營業績的預期、信念、估計或預測相關的陳述。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。

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 June 30, 2022. Both of which have been filed with the Securities and Exchange Commission and the company's quarterly report on Form 10-Q for the 3 months ended September 30, 2022, which the company intends to file with the Securities and Exchange Commission on or before November 14, 2022. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com.

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 6 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 9 月 30 日止三個月的 10-Q 表季度報告，該公司擬於 2022 年 11 月 14 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 獲得。

It is now my pleasure to introduce Joe Burnett, Chief Executive Officer. Thank you, sir. You may begin.

現在我很高興介紹首席執行官 Joe Burnett。謝謝你，先生。你可以開始了。

Thank you, and thank you to all of our investors and analysts on today's call for being a part of the ClearPoint vision and journey. Our mission and our priorities are to help restore quality of life to patients and their families who are suffering from some of the most debilitating neurological disorders imaginable. We cannot do this without your support.

謝謝，也感謝我們所有的投資者和分析師今天呼籲成為 ClearPoint 願景和旅程的一部分。我們的使命和優先事項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。沒有您的支持，我們無法做到這一點。

In the third quarter of 2022, we 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.

2022年第三季度，我們繼續在我們的四大支柱增長戰略中取得進展，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。

Despite a continued high cancellation rate due to COVID, historically high surgeon transitions and daily supply chain and hospital staffing challenges, our team was able to achieve near record revenue of $5.1 million for the third [quarter], representing 13% year-over-year growth.

儘管由於 COVID 導致取消率持續居高不下，外科醫生的過渡率處於歷史高位以及日常供應鍊和醫院人員配備挑戰，但我們的團隊在第三 [季度] 實現了接近創紀錄的 510 萬美元的收入，同比增長 13%生長。

As a company, we believe we remain well capitalized with over $40 million in cash and short term investments, and we'll continue to execute against our strategy and carefully manage our expenses.

作為一家公司，我們相信我們擁有超過 4000 萬美元的現金和短期投資，資本充足，我們將繼續執行我們的戰略並謹慎管理我們的開支。

We continue to expect total revenue for 2022 to be in the range of $21 million to $22 million, representing 30% to 35% growth for the year, depending on timing of revenue recognition for some capital sales and biologic services.

我們繼續預計 2022 年的總收入將在 2100 萬美元至 2200 萬美元之間，同比增長 30% 至 35%，具體取決於某些資本銷售和生物服務的收入確認時間。

I will now turn the call over to Danilo, our CFO, to review our financial performance in the third quarter. After which, I will add some detail to our 4-pillar growth strategy. Danilo?

我現在將電話轉給我們的首席財務官 Danilo，以審查我們在第三季度的財務業績。之後，我將為我們的四大支柱增長戰略添加一些細節。達尼洛？

Thank you, Joe, and thank you all for being here with us today.

謝謝你，喬，感謝大家今天和我們在一起。

Looking at the third quarter 2022 results. Total revenue was $5.1 million for the 3 months ended September 30, 2022, and $4.6 million for the 3 months ended September 30, 2021, which represents 13% growth versus the third quarter of 2021.

看看 2022 年第三季度的結果。截至 2022 年 9 月 30 日止三個月的總收入為 510 萬美元，截至 2021 年 9 月 30 日止三個月的總收入為 460 萬美元，較 2021 年第三季度增長 13%。

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 relating to cases utilizing the ClearPoint system to deliver medical device therapy to the proper target. This revenue segment increased 12% to $2.4 million for the third quarter, up from $2.2 million in the third quarter of 2021.

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一次性產品的商業銷售和與使用 ClearPoint 系統將醫療設備治療提供給正確目標的案例相關的服務。該收入部分第三季度增長 12% 至 240 萬美元，高於 2021 年第三季度的 220 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 9% to $2.2 million in the second quarter, up from $2.1 million in 2021.

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。第二季度生物製品和藥物輸送收入增長 9%，達到 220 萬美元，高於 2021 年的 210 萬美元。

Capital equipment and software revenue consists of sales of ClearPoint reusable hardware and software and of related services increased 32% to $0.5 million for the third quarter from $0.4 million for the same period in 2021, following an increase in the placement of ClearPoint capital and software.

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，第三季度從 2021 年同期的 40 萬美元增長 32% 至 50 萬美元，這得益於 ClearPoint 資本和軟件的配置增加。

We achieved a gross margin of 72% in the third quarter of 2022, 6% higher than the 66% gross margin recorded in the third quarter of 2021. The increase in gross margin was mostly due to increased contribution of service revenue and lower overhead expenses.

我們在 2022 年第三季度實現了 72% 的毛利率，比 2021 年第三季度的 66% 毛利率高出 6 個百分點。毛利率的增長主要是由於服務收入的貢獻增加和管理費用減少.

Research and development costs were $2.5 million in Q3 compared to $2.6 million for the same period in 2021, a decrease of $0.1 million or 6%. The decrease was due primarily to lower product development costs as a result of reprioritization of certain research and development initiatives.

第三季度的研發成本為 250 萬美元，而 2021 年同期為 260 萬美元，減少 10 萬美元或 6%。減少的主要原因是由於重新確定某些研發計劃的優先級而導致產品開發成本降低。

Sales and marketing expenses were $2.1 million for the third quarter compared to $1.8 million for the same period in 2021, an increase of $0.3 million or 18%. This increase was due primarily to additional personnel costs resulting from an increase in head count of $0.2 million as we expanded our clinical team as well as increases in travel costs of $0.1 million.

第三季度的銷售和營銷費用為 210 萬美元，而 2021 年同期為 180 萬美元，增加了 30 萬美元或 18%。這一增長主要是由於我們擴大臨床團隊導致人員增加 20 萬美元以及差旅費用增加 10 萬美元導致的額外人員成本。

General and administrative expenses were $2.9 million in Q3 compared to $2.4 million for the same period in 2021, an increase of $0.5 million or 20%. This increase was due primarily to increased share-based compensation of $0.5 million.

第三季度的一般和行政費用為 290 萬美元，而 2021 年同期為 240 萬美元，增加了 50 萬美元或 20%。這一增長主要是由於股票薪酬增加了 50 萬美元。

Net interest income in the third quarter was $30,000 compared to $0.2 million of net interest expense for the same period in 2021. The increase in interest income was due to the company's investment in United States Treasury bills and the resulting higher interest rates, as well as lower debt principal due to the conversion of a portion of the 2020 secured convertible notes in May and November 2021.

第三季度的淨利息收入為 30,000 美元，而 2021 年同期的淨利息支出為 20 萬美元。利息收入的增加是由於公司對美國國庫券的投資以及由此帶來的更高利率，以及由於在 2021 年 5 月和 2021 年 11 月轉換了部分 2020 年有擔保可轉換票據，因此債務本金較低。

In the third quarter, our operational cash burn was $3.8 million, which was lower than our Q1 and Q2 operational cash burn. As we continue to face a challenging supply chain environment, we deployed more capital near term to solidify vendor supply in our supply chain reliability. We continue to expect a further step down in our operational cash burn in the upcoming fourth quarter and remain confident we are well capitalized to achieve our mid-term growth ambitions.

第三季度，我們的運營現金消耗為 380 萬美元，低於第一季度和第二季度的運營現金消耗。由於我們繼續面臨充滿挑戰的供應鏈環境，我們近期部署了更多資金，以鞏固我們供應鏈可靠性中的供應商供應。我們繼續預計在即將到來的第四季度我們的運營現金消耗將進一步減少，並且仍然相信我們有充足的資本來實現我們的中期增長目標。

With respect to our cash position, we finished the quarter with cash and short term investments of $40.5 million compared to $54.1 million as of December 31, 2021.

關於我們的現金狀況，截至 2021 年 12 月 31 日，我們的現金和短期投資為 4050 萬美元，而截至 2021 年為 5410 萬美元。

At this point, I'd like to turn the call back to Joe.

在這一點上，我想把電話轉回給喬。

Thank you, Danilo. The third quarter of 2022 was another quarter of progress and execution against our 4-pillar growth strategy. This included FDA clearance of 3 new navigation and therapy products, the addition of multiple new biotech partners, the installation of systems at new hospitals and the hiring of talented professionals across multiple functions bringing our direct employee count to just under 100. This is not including the support and teamwork we received from our pharma, biotech and device partners that make us look and feel much larger.

謝謝你，達尼洛。 2022 年第三季度是我們四大支柱增長戰略取得進展和執行的又一個季度。這包括 FDA 批准 3 種新的導航和治療產品、增加多個新的生物技術合作夥伴、在新醫院安裝系統以及在多個職能部門聘用有才華的專業人員，使我們的直接員工人數達到近 100 人。這不包括我們從製藥、生物技術和設備合作夥伴那裡獲得的支持和團隊合作讓我們看起來和感覺起來都更大了。

Let's break that progress down into those 4 growth pillars. First, our biologics and drug delivery team continued to add additional partners and services into the third quarter, adding multiple new partners to our account, which is now approximately 50 active relationships in the space. We continue to keep pace with our past 2 years' history of adding approximately 1 new partner every month.

讓我們將這一進展分解為這 4 個增長支柱。首先，我們的生物製劑和藥物輸送團隊在第三季度繼續增加更多的合作夥伴和服務，為我們的賬戶增加了多個新合作夥伴，目前該領域大約有 50 個活躍的關係。我們繼續保持過去 2 年每月增加大約 1 個新合作夥伴的歷史。

We have also hired multiple new team members and expertise to the biologics and drug delivery team, increasing the scope of services we can provide, and in turn, the total potential revenue opportunity with these pharma partners prior to commercialization.

我們還為生物製劑和藥物輸送團隊聘請了多名新團隊成員和專業知識，擴大了我們可以提供的服務範圍，進而增加了在商業化之前與這些製藥合作夥伴的總潛在收入機會。

Now this is an important distinction that I want to make sure to highlight. If one of our partners or even one of the programs within a partner would purchase the entire suite of products and services that our team can now provide, the total value of those products and services from initiation of the program through the completion of a Phase III clinical trial could potentially add up to $10 million per program before the drug or biologic is even approved. Therefore, our newly added capabilities will allow to access a total addressable market of several hundred dollars million in the pre-commercial space. This is one of the reasons that we believe that we can ramp revenue and achieve profitability without requiring the contribution of large commercially available drug therapies during that time horizon.

現在，這是我要強調的一個重要區別。如果我們的合作夥伴之一或什至合作夥伴中的一個計劃將購買我們團隊現在可以提供的整套產品和服務，則這些產品和服務從計劃啟動到第三階段完成的總價值在藥物或生物製劑獲得批准之前，臨床試驗可能會為每個項目增加 1000 萬美元。因此，我們新增的功能將允許在預商業領域進入一個總計數億美元的潛在市場。這是我們相信我們可以增加收入並實現盈利的原因之一，而無需在此期間提供大量商用藥物療法。

Arguably, our biggest milestone in the past 3 months was the first commercial patient treated with PTC's Upstaza gene therapy products for the treatment of AADC deficiency in Europe under CE Mark authorization. Our multiyear strategy has played out as expected, where the labeling for Upstaza includes our SmartFlow Cannula directly in the surgical guide as the only infusion cannulas to be used in combination with this gene therapy. To say it another way, the very first gene therapy ever approved for direct injection into the brain is co-labeled with our device and the marketing authorization for administration of a therapy.

可以說，我們在過去 3 個月裡最大的里程碑是在 CE 標誌授權下，歐洲首例使用 PTC 的 Upstaza 基因治療產品治療 AADC 缺陷的商業患者。我們的多年戰略如預期的那樣發揮了作用，Upstaza 的標籤包括我們的 SmartFlow 插管直接在手術指南中作為唯一與這種基因療法結合使用的輸液插管。換句話說，有史以來第一個被批准用於直接注射到大腦中的基因療法與我們的設備和治療管理的營銷授權共同標記。

We believe this first approval, along with the exhaustive bench, preclinical and clinical testing required for submission, is a sign of things to come for many of our approximately 50 active partners that could see a similar path to approval. Our goal for our SmartFlow family of cannula products is to achieve co-labeling globally across multiple partners and indications, and that ClearPoint is the go-to delivery mechanism for pharma delivery to the brain and spine.

我們相信，對於我們大約 50 個活躍的合作夥伴中的許多人來說，這第一次批准以及提交所需的詳盡的工作台、臨床前和臨床測試是一個跡象，這些合作夥伴可能會看到類似的批准途徑。我們的 SmartFlow 插管產品系列的目標是在全球範圍內實現多個合作夥伴和適應症的聯合標籤，而 ClearPoint 是將藥物輸送到大腦和脊柱的首選輸送機制。

Second, our functional neurosurgery navigation business achieved a number of key milestones in the quarter, including the FDA clearance of the 2.1 version software and the Maestro Brain Model. These 2 software tools represent our second and third software approvals this year and show the cadence of new product introductions that we plan to continue as -- and demonstrate ClearPoint as an innovator in the neurosurgery space. There is still a tremendous amount we can do to make our procedures faster, more informative and more predictable, which will help to drive utilization, increase 2-a-day procedures in the same MRI magnet and enable some procedures to be done without a ClearPoint representative present at the case.

其次，我們的功能性神經外科導航業務在本季度實現了多個關鍵里程碑，包括 2.1 版軟件和 Maestro 大腦模型獲得 FDA 批准。這兩個軟件工具代表了我們今年第二次和第三次軟件批准，並展示了我們計劃繼續推出新產品的節奏——並展示了 ClearPoint 作為神經外科領域的創新者。我們仍然可以做很多事情來使我們的程序更快、信息更豐富和更可預測，這將有助於提高利用率，增加同一 MRI 磁體中每天 2 次的程序，並使某些程序無需 ClearPoint 即可完成出席本案的代表。

Currently, we now have installed 10 systems year-to-date, which is a new record with a couple of months still to go in 2022. We have more than 40 additional hospitals in our active funnel, which again is the strongest installation and capital funnel that we have had in our history.

目前，我們今年迄今已經安裝了 10 個系統，這是一個新記錄，距離 2022 年還有幾個月的時間。我們的活躍漏斗中還有 40 多家醫院，這再次是最強大的安裝和資本我們歷史上的漏斗。

Our cancellation or postponement rate does remain at a very high level with the most common reason being patient or surgeon sickness, be it COVID or the flu or other. As we move into the winter months, we expect this high rate to continue for the time being.

我們的取消或推遲率確實保持在非常高的水平，最常見的原因是患者或外科醫生生病，無論是 COVID 還是流感或其他。隨著我們進入冬季，我們預計這種高利率將暫時持續下去。

For our third pillar, therapy products and access devices in collaboration with our Swedish partner, CLS, we achieved FDA clearance of the Prism Laser Therapy System, which was granted here in the third quarter. This product will enable our team of clinical specialists not only navigation, but also therapy to 2 distinct markets in epilepsy and in neuro-oncology. We are in the process of working with a handful of existing ClearPoint users to get the laser system installed and continue to expect first clinical cases under a limited market release before the end of this year.

對於我們的第三個支柱，治療產品和接入設備，我們與我們的瑞典合作夥伴 CLS 合作，我們在第三季度獲得了 Prism 激光治療系統的 FDA 批准。該產品將使我們的臨床專家團隊不僅能夠導航，而且能夠治療癲癇和神經腫瘤學這兩個不同的市場。我們正在與一些現有的 ClearPoint 用戶合作安裝激光系統，並繼續期待在今年年底之前在有限的市場發布下首批臨床病例。

It is also important to note that the majority of our investment into the navigation system mentioned in Pillar 2 applies to biologics and drug delivery as well as our therapy products. That is the beauty of our platform strategy as much of the investment is applied across many indications, including biologics, deep brain stimulation, laser ablation, biopsy, brain computer interfaces and perhaps others in the future.

同樣重要的是要注意，我們對支柱 2 中提到的導航系統的大部分投資適用於生物製劑和藥物輸送以及我們的治療產品。這就是我們平台戰略的美妙之處，因為大部分投資應用於許多適應症，包括生物製劑、深部腦刺激、激光消融、活檢、腦機接口以及未來可能的其他適應症。

This is crucial from a training standpoint as well. Every biopsy case, laser ablation case or deep brain simulation case a hospital performs with ClearPoint today, is, in fact, training and preparing them to do biologics and brain computer interface cases in the future.

從培訓的角度來看，這也是至關重要的。醫院今天使用 ClearPoint 執行的每個活檢病例、激光消融病例或深部腦模擬病例，實際上都是在培訓和準備他們在未來進行生物製劑和腦機接口病例。

Finally, our fourth pillar of achieving global scale has made progress as well. In addition to receiving MDSAP and EU MDR certification earlier in the year, we have placed additional systems in Europe to expand our global footprint and prepare for future drug delivery trial enrollment.

最後，我們實現全球規模的第四個支柱也取得了進展。除了在今年早些時候獲得 MDSAP 和歐盟 MDR 認證外，我們還在歐洲部署了更多系統，以擴大我們的全球足跡並為未來的藥物輸送試驗註冊做準備。

As Danilo mentioned earlier, a significant portion of our cash burn went toward working capital, including prepaid inventory and expenses and raw material and component purchases. We believe some of these inventory purchases will start to slow down here in the fourth quarter, which will be offset by inventory of new products, for example, laser systems to support the limited market release.

正如 Danilo 之前提到的，我們現金消耗的很大一部分用於營運資金，包括預付庫存和費用以及原材料和組件採購。我們認為，其中一些庫存採購將在第四季度開始放緩，這將被新產品的庫存所抵消，例如支持有限市場釋放的激光系統。

We also just signed a 10-year lease under favorable terms for a new 20,000 square foot manufacturing facility in San Diego close by our training and innovation center. We have outgrown our current facility in Irvine and the new facility will add space and capacity to support a more than $100 million revenue business. We will take possession of the building in Q2 of 2023 and be able to design from the ground up following lean principles to support greater efficiency.

我們還剛剛以優惠條款簽署了一份為期 10 年的租約，在我們的培訓和創新中心附近的聖地亞哥新建一個 20,000 平方英尺的製造工廠。我們在爾灣的現有設施已經無法滿足需求，新設施將增加空間和產能，以支持收入超過 1 億美元的業務。我們將在 2023 年第二季度接收該建築，並能夠按照精益原則從頭開始設計，以支持更高的效率。

This year, we have also hired 8 additional clinical specialists which adds significantly more capacity to our surgical team in preparation for growth in 2023 and 2024.

今年，我們還聘請了 8 名額外的臨床專家，這大大增加了我們外科團隊的能力，為 2023 年和 2024 年的增長做準備。

We are reiterating our full year 2022 revenue guidance of between $21 million and $22 million, which corresponds to annual growth between 30% and 35% for the year. We also continue to believe that our current cash and short-term investment position of more than $40 million does not require us to raise additional capital to support our current portfolio and strategy this year.

我們重申我們的 2022 年全年收入指引在 2100 萬美元至 2200 萬美元之間，相當於全年 30% 至 35% 的年增長率。我們還繼續相信，我們目前超過 4000 萬美元的現金和短期投資頭寸不需要我們籌集額外資金來支持我們今年的當前投資組合和戰略。

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

有了這個，我想打開任何問題的電話。

(Operator Instructions) Our first question comes from Marc with B. Riley Securities.

（操作員說明）我們的第一個問題來自 B. Riley Securities 的 Marc。

This is William Wood on for Marc Wiesenberger of B. Riley Securities. Congratulations on a really productive quarter.

我是 B. Riley Securities 的 Marc Wiesenberger 的 William Wood。祝賀一個真正富有成效的季度。

We've got a couple of you. So I'll start with -- we've got a couple, as I said. So I'll start with the first one. So just curious if you can talk about how the conversations with your [PTC] partners have continued to evolve. And as the partners move from preclinical to the clinical phase, are you seeing any changes to the decision making process?

我們有你們幾個。所以我將從 - 正如我所說的那樣，我們有一對。所以我將從第一個開始。所以很好奇你是否可以談談與你的 [PTC] 合作夥伴的對話是如何繼續發展的。隨著合作夥伴從臨床前階段進入臨床階段，您是否看到決策過程有任何變化？

William, thanks for the question. So obviously, we're having conversations on a daily basis. In fact, whether it's an introductory call or an audit of our facility or a live product demonstration, these are happening, if not a daily basis, then certainly a weekly basis. And I can't say that they've changed materially in any way.

威廉，謝謝你的提問。很明顯，我們每天都在進行對話。事實上，無論是介紹性電話、對我們設施的審計還是現場產品演示，這些都在發生，如果不是每天一次，那麼肯定是每週一次。而且我不能說它們以任何方式發生了重大變化。

I think many companies, I'd say if there are any differences to historical amounts. One has been around sort of frustrations with the same things that we're seeing in the field relative to hospital delays and supply chain disruptions that are certainly slowing things down to some extent, but not stopping them like we saw back in April of 2020. So I think if anything, that's still a positive that these things are moving forward.

我認為很多公司，如果與歷史金額有任何差異，我會說。人們一直對我們在該領域看到的與醫院延誤和供應鏈中斷相關的事情感到沮喪，這些事情肯定在某種程度上減緩了速度，但並沒有像我們在 2020 年 4 月看到的那樣阻止它們。所以我認為，如果有的話，這些事情正在向前發展仍然是積極的。

And then in some of those cases, we've heard that some partners have had to sort of prioritize some of their internal programs just to go ahead and kind of reduce the burn and save capital, especially some of the smaller companies that might be -- might see a capital raise on the horizon. They might be forced to slow down their second and third options and focus their attention and detail on option #1 in their platform. But outside of that, there's no other kind of large material differences, I would see.

然後在其中一些情況下，我們聽說一些合作夥伴不得不對他們的一些內部計劃進行排序，以便繼續進行並減少燒錢並節省資金，尤其是一些可能是 - - 可能會在地平線上看到融資。他們可能被迫放慢第二個和第三個選項，並將注意力和細節集中在平台上的選項 #1 上。但除此之外，我認為沒有其他重大的物質差異。

If anything, I think people are more and more excited about the space given now that PTC and Upstaza has been the first gene therapy approved to the brain. It's certainly open doors for us. And that's -- we expect to see that pace of new partners continue in the year ahead.

如果有的話，我認為人們對 PTC 和 Upstaza 已成為第一個批准用於大腦的基因療法的空間感到越來越興奮。這當然為我們敞開了大門。那就是——我們希望看到新合作夥伴的步伐在未來一年繼續下去。

Right. That makes a lot of sense. And then with regard to the -- your Prism Neuro Laser Therapy System, can you lay out how you expect penetration in the market to evolve over the next, say, 12 to 18 months? And specifically, how do you go about converting surgeons from incumbents in the market? And then what are the primary factors driving their decisions?

正確的。這很有意義。然後關於——你的 Prism 神經激光治療系統，你能說明你預計在接下來的 12 到 18 個月內市場滲透率會如何發展嗎？具體來說，您如何將外科醫生從市場上的現任者轉變為外科醫生？那麼推動他們做出決定的主要因素是什麼？

Well, I mean, I think we're going to probably operate within a limited market release for the balance of this year and at least through the first half of 2023. This is our first therapy product, and we want to make sure that we're doing it in the most responsible manner ever. So I see us starting primarily with our existing users that are already using ClearPoint navigation for their laser cases.

好吧，我的意思是，我認為我們可能會在今年餘下時間和至少到 2023 年上半年在有限的市場發布範圍內運營。這是我們的第一個治療產品，我們想確保我們以有史以來最負責任的方式做這件事。因此，我認為我們主要從我們的現有用戶開始，這些用戶已經在他們的激光案例中使用 ClearPoint 導航。

I don't expect us to always convert all of the business at a hospital over to ClearPoint. But I think our reputation in the market and the quality of our products has earned us the right to at least get a trial, and most of the surgeons that we've spoken to at this point at our active centers are more than happy to give us a chance.

我不希望我們總是將醫院的所有業務都轉移到 ClearPoint。但我認為我們在市場上的聲譽和我們產品的質量已經為我們贏得了至少獲得試用的權利，而且我們在這一點上與我們在活躍中心交談過的大多數外科醫生都非常樂意提供我們有機會

And I think one of the biggest components of why they're willing to use our technology, is, again, the team that we've established and the competency and credibility of our clinical specialist team. The thought process of us having 1 person that can be responsible for the entire procedure, starting at the beginning with the navigation and all the way through to the end with the delivering of the therapy is something that's very attractive, with handoff and responsibility halfway through. So I think that's going to be a major component for us. And we're very, very excited about this laser market and excited to get started. As I mentioned, we do expect the first couple of cases to really happen here in the next month or so.

我認為，他們願意使用我們技術的最大組成部分之一，再次是我們建立的團隊以及我們臨床專家團隊的能力和信譽。我們有一個人可以負責整個過程的思維過程，從導航開始，一直到治療的結束，這是非常有吸引力的，中間有交接和責任.所以我認為這將成為我們的主要組成部分。我們對這個激光市場感到非常非常興奮，並且很高興能夠開始。正如我所提到的，我們確實希望前幾個案例在下個月左右真正發生在這裡。

Awesome. We look forward to see how that pans out. With -- can you talk a little about how your domestic versus ex U.S. expansion is progressing? I know you've mentioned Europe a little bit. And do you expect to see any material changes to either U.S. or obviously ex U.S. in the near term? And then additionally, can you update us on your expansion efforts in China?

驚人的。我們期待看到結果如何。隨著 - 你能談談你的國內和美國以外的擴張進展如何嗎？我知道你已經稍微提到了歐洲。您是否期望在短期內看到美國或明顯不包括美國的任何重大變化？另外，您能否向我們介紹一下您在中國的擴張努力？

Yes, sure thing. So domestically, I think that's where most of the revenue dollar growth is -- we expect in the next couple of years as well, whether it's through our laser program, through new customers that are interested in doing MRI-guided DBS, the number I guided laser procedure and eventually our expansion into the operating room as well. So the U.S. is still going to be the primary focus.

是的，當然。所以在國內，我認為這是大部分收入增長的地方——我們預計在接下來的幾年裡，無論是通過我們的激光項目，還是通過對 MRI 引導的 DBS 感興趣的新客戶，我的數字引導激光程序，最終我們也擴展到手術室。因此，美國仍將是主要焦點。

Arguably, we're going into Europe a little bit earlier than we normally would. But again, this is in order to support our biologics and drug delivery customers that are interested in enrolling clinical trials across Europe with local researchers, especially for our European partners.

可以說，我們進入歐洲的時間比平時要早一點。但同樣，這是為了支持我們的生物製劑和藥物輸送客戶，這些客戶有興趣與當地研究人員一起在歐洲進行臨床試驗，尤其是我們的歐洲合作夥伴。

So where we don't expect a massive revenue opportunity for DBS or laser ablation in the near term in Europe. We are expecting to initiate a number of clinical trials in the next couple of years in Europe. And in most cases, the pharma companies we're working with don't want the very first patient in their trial to be their first patient where the doctor is using ClearPoint. So we do a number of roll-in patients as typical where they might do a biopsy, a laser procedure, a DBS procedure to get familiar with ClearPoint before they start enrolling those patients. So most of our revenue opportunity in the near term is going to be around clinical trial sites that are becoming familiar with our technology in Europe.

因此，我們預計短期內歐洲的 DBS 或激光消融不會有巨大的收入機會。我們預計未來幾年將在歐洲啟動多項臨床試驗。在大多數情況下，與我們合作的製藥公司不希望他們試驗中的第一個患者成為醫生使用 ClearPoint 的第一個患者。因此，我們對一些典型的入組患者進行了檢查，他們可能會在開始招募這些患者之前進行活組織檢查、激光手術、DBS 手術以熟悉 ClearPoint。因此，我們在短期內的大部分收入機會將圍繞著越來越熟悉我們在歐洲的技術的臨床試驗站點。

We do have approval in Singapore. We do have approval in Israel at this point. And we have started our submission process in a number of other countries, including Brazil, for example. And as -- but in each of those situations, it's not that we're trying to penetrate the entire country of Brazil, for example. It would be the same Center of Excellence model, where we have our system installed in 1 or 2 centers. And then we'd be transporting these patients with chronic diseases to get treated at these centers of excellence, not at their local hospital across the street.

我們確實在新加坡獲得了批准。在這一點上，我們確實在以色列獲得了批准。我們已經在許多其他國家/地區啟動了提交流程，例如巴西。而且——但是在每一種情況下，例如，並不是我們試圖滲透到整個巴西國家。這將是相同的卓越中心模型，我們將系統安裝在 1 或 2 個中心。然後我們會運送這些慢性病患者到這些卓越中心接受治療，而不是在街對面的當地醫院。

And I think you specifically asked on China. China, we're evaluating a couple of other options. Again, we have the luxury, I would say, although not confirmed in [that again] is focused on centers of excellence, meaning we're not trying to deploy our technology across an entire country, but maybe at only even 1 hospital or 2 hospitals in a country. And there's actually a number of sort of alternative regulatory pathways, where if it is a very, very focused technology like what we're trying to deploy, there's ways to accelerate that access to technology. So that's something we're exploring in different countries. But most of our OUS expansion is really at the request of our biologics partners and not necessarily something we're driving on our own. Hopefully that helps you.

我想你特別問了中國。中國，我們正在評估其他幾個選項。再一次，我想說，我們有奢侈，雖然在 [再次] 中沒有證實專注於卓越中心，這意味著我們不會試圖在整個國家部署我們的技術，但可能只在 1 家或 2 家醫院部署一個國家的醫院。實際上有多種替代監管途徑，如果它是一種非常非常集中的技術，就像我們正在嘗試部署的那樣，那麼就有辦法加速對技術的訪問。所以這是我們正在不同國家探索的東西。但我們 OUS 的大部分擴張實際上是應我們的生物製劑合作夥伴的要求，而不一定是我們自己推動的。希望這對你有幫助。

Yes, absolutely. And then finally from us, can you talk about how your COVID restrictions impacted you in the quarter? And maybe just quantify the drag if there was any, I know you sort of touched on this already.

是的，一點沒錯。最後，您能否談談您的 COVID 限制在本季度對您產生了怎樣的影響？如果有任何阻力，也許只是量化阻力，我知道你已經有點觸及了。

Yes. I don't have too much to add other than it's always the worst surprise when you show up at the hospital that morning all ready to go and the patient fails their COVID test and has to postpone for a couple of weeks because, in general, we've then lost the airfare. We've lost the day of capacity from our clinical team, and we've lost the MRI day. So it's kind of painful for us. It's great we don't lose the patient. We're still able to treat them and help them in the next 2 weeks. However, that day, we lose the case.

是的。我沒有太多要補充的，除了當你那天早上出現在醫院時，一切都準備好了，而病人沒有通過 COVID 測試，不得不推遲幾週，這總是最糟糕的驚喜，因為一般來說，然後我們就失去了機票。我們失去了臨床團隊的能力日，也失去了 MRI 日。所以這對我們來說有點痛苦。很高興我們沒有失去病人。我們仍然能夠在接下來的 2 週內對他們進行治療和幫助。然而，那天，我們敗訴了。

And historically, pre-COVID, our sort of routine cancellation or postponement rate was always in that 8% to 12% range. Since COVID initiated and sort of has calmed down from the initial stoppage, that postponement rate has been north of 30%. So the good news is we're scheduling more cases, but there's still a very high percentage that currently are being canceled. And I think we're seeing this in a number of different avenues. But in our case, if the patient has COVID or our specialist has COVID or the surgeon has COVID or the MRI tech has COVID, if any 1 of those 4 essential parts of the equation, test positive for that or the flu or RAC or anything like that, we end up losing the case that day, which is unfortunate.

從歷史上看，在 COVID 之前，我們的例行取消或推遲率總是在 8% 到 12% 的範圍內。自從 COVID 啟動並從最初的停工中平靜下來以來，延期率一直在 30% 以上。所以好消息是我們正在安排更多案例，但目前仍有很高比例的案例被取消。我認為我們在許多不同的途徑中看到了這一點。但在我們的案例中，如果患者患有 COVID，或者我們的專家患有 COVID，或者外科醫生患有 COVID，或者 MRI 技術人員患有 COVID，如果等式的這 4 個基本部分中的任何 1 個，測試陽性或流感或 RAC 或任何東西就這樣，我們最終以敗訴告終，這很不幸。

Makes sense.

說得通。

And William, to continue on that too, we're going into the winter months. Kind of expect sort of the suppressed or high postponement rates to continue at least until the spring. So certainly for the next 2 quarters is kind of what we've built into our plan.

威廉，要繼續這樣做，我們將進入冬季。某種程度的抑製或高延期率至少會持續到春季。因此，接下來的兩個季度肯定是我們計劃中的內容。

Okay. Understandable.

好的。可以理解。

(Operator Instructions) Our next question comes from Frank with Lake Street Capital Markets.

（操作員說明）我們的下一個問題來自 Lake Street Capital Markets 的 Frank。

I wanted to start with your new commentary around biologic and drug delivery total revenue per asset potential, I think you called out $10 million on the call. I was hoping you could walk us through that figure in a little bit more detail and more specifically talking to the cadence of recognition across the drug's development. My assumption is once it becomes Phase III, it becomes a much larger revenue opportunity. But maybe just kind of walk us through how that $10 million is recognized over the life of development for a specific asset.

我想從你關於每項資產潛力的生物製品和藥物輸送總收入的新評論開始，我想你在電話會議上提到了 1000 萬美元。我希望你能更詳細地向我們介紹這個數字，更具體地談談藥物開發過程中的認可節奏。我的假設是一旦進入第三階段，它就會成為一個更大的收入機會。但也許只是讓我們了解一下如何在特定資產的開發生命週期內確認這 1000 萬美元。

Yes, sure thing. So maybe building backwards since you brought up the clinical trial revenue itself. A typical -- I'm going to say typical because a lot of our pharma companies are still learning. But to put it in perspective, if you remember the study that the FDA had approved for Voyager Therapeutics to treat Parkinson's disease, which again is a moderate-sized market opportunity in the grand scheme of things, an opportunity that would require a sham arm because there are alternative treatments for the disease. That's kind of the best barometer we have of what normal might look like for trial design.

是的，當然。因此，自從您提出臨床試驗收入本身以來，也許會倒退。典型——我要說典型是因為我們的許多製藥公司仍在學習。但從長遠來看，如果你還記得 FDA 批准 Voyager Therapeutics 治療帕金森病的研究，這在宏偉的計劃中又是一個中等規模的市場機會，這個機會需要假手，因為這種疾病有替代療法。這是我們擁有的最好的晴雨表，用於試驗設計的正常情況。

And for their Phase II and Phase III trials that they were granted to operate in parallel, I believe the target number of patients in those trials were about 220, okay? So if you look at the Phase II, Phase III aspect of it, we were selling approximately $20,000 of equipment into that trial between navigation and cannulas. So $4 million of it is really product-related revenue that you would see in the Phase II and Phase III. So kind of the outward years just before commercialization. So that's sort of one bucket.

對於他們獲准並行進行的 II 期和 III 期試驗，我相信這些試驗的目標患者人數約為 220 人，好嗎？因此，如果你看一下它的第二階段、第三階段方面，我們在導航和插管之間的試驗中銷售了大約 20,000 美元的設備。因此，其中 400 萬美元實際上是您在第二階段和第三階段看到的與產品相關的收入。就在商業化之前的那些年。所以這是一個桶。

Backing up from there, you have to do your safety trials, your Phase I and a couple of Phase Ia trials, things like that, which can be anywhere from 30 to, I think, 48 patients is a typical size that we've seen with some of our existing partners. So again, with that same $20,000 per case estimate, that's about $1 million for kind of that Phase I and Phase Ia safety study, Phase Ia/Phase Ib. So probably in -- I'm sorry, $5 million of the $10 million, I would expect to be within the clinical trial product category of that estimate.

從那裡備份，你必須做你的安全試驗，你的 I 期和幾個 Ia 期試驗，諸如此類，可以是 30 到 48 名患者，我認為這是我們看到的典型規模與我們現有的一些合作夥伴。因此，同樣，每個案例的估計費用為 20,000 美元，I 期和 Ia 期安全研究 Ia/Ib 期的費用約為 100 萬美元。所以可能在 - 對不起，1000 萬美元中的 500 萬美元，我希望屬於該估計的臨床試驗產品類別。

So everything else is coming from preclinical work, whether it's NHP work that's commonly done at sites like Charles River, for example, or other CROs that are in the area. Some of the services that we've added are that we've hired actual surgeons. We've hired veterinarians. We've hired study directors. We can write protocols, so we can actually execute a number of these studies in a way that normally you would have to go to a massive CRO and sort of get in line for. So that's really where the other half of that $10 million comes from is consulting, it's toxicology studies, it's benchtop studies, it's flow studies. One of the things the FDA is asking for is whatever the component makeup of the drug or cell therapy that you're putting in one side of the cannula, you have to be able to characterize what's coming out at the other end. Who's better to do that than a company like us that focuses and actually makes the cannula itself.

因此，其他一切都來自臨床前工作，無論是通常在查爾斯河等地點完成的 NHP 工作，還是該地區的其他 CRO。我們增加的一些服務是我們聘請了真正的外科醫生。我們聘請了獸醫。我們聘請了研究主管。我們可以編寫協議，因此我們實際上可以以通常您必須去大型 CRO 並排隊等候的方式執行許多此類研究。因此，這 1000 萬美元中的另一半實際上來自諮詢、毒理學研究、台式研究和流動研究。 FDA 要求的其中一件事是，無論您放入插管一側的藥物或細胞療法的成分是什麼，您都必須能夠描述從另一端流出的成分。誰能比像我們這樣專注於並實際製造插管本身的公司更好地做到這一點。

So these are the types of things where if you reverted back maybe 2 years ago, I would say the most that we could possibly sell to a company was in that $5 million range because we just didn't have any of these services, compared to everyone we've hired in these capabilities that the team has built has effectively doubled the opportunity we have with each one of these partners. So hopefully, that's enough color, but I'm happy to answer any other parts of that.

所以如果你回到 2 年前，我會說我們可能賣給一家公司的最多的東西是在 500 萬美元的範圍內，因為我們只是沒有任何這些服務，相比之下我們聘請的每個人都具有團隊建立的這些能力，這有效地使我們與這些合作夥伴中的每一個合作的機會增加了一倍。希望這些顏色足夠了，但我很樂意回答其中的任何其他部分。

That's perfect. I was hoping that just as an extension to that question. Of your 50 partners, if you're thinking about an approximate number, how many of those could be approaching a Phase II or Phase III trial in the next, call it, 12 to 24 months to try and tease out which ones are approaching that inflection point?

那很完美。我希望這只是對該問題的擴展。在你的 50 個合作夥伴中，如果你正在考慮一個大概的數字，其中有多少可以在接下來的 12 到 24 個月內進入 II 期或 III 期試驗，以嘗試梳理出哪些正在接近那個拐點？

Yes. I mean, 2023, I think we're going to see the initiation of a lot more of the Phase I studies, for example. So in the next 15 months, I think it's going to be highly focused there with maybe a couple of Phase IIs that begin. However, if the timing holds or the time line holds for enough of these programs, then you could see 5 to 10 in that Phase II range starting probably in 2024. I think that's kind of realistic based on where some of our partners are.

是的。我的意思是，到 2023 年，我認為我們將看到更多的第一階段研究的啟動。因此，在接下來的 15 個月裡，我認為它將高度關注那裡，可能會開始幾個第二階段。但是，如果時間安排或時間表適用於足夠多的這些計劃，那麼您可能會在 2024 年開始的第二階段範圍內看到 5 到 10 個。我認為根據我們的一些合作夥伴所在的位置，這有點現實。

The one caveat I'd add to that though is that some of these, there is an alternative where, with some of these very rare pediatric disorders, you don't necessarily have to go through the same gamut. So it could be a different -- there could actually be commercialization of some by 2024, albeit there's kind of smaller, rare disease opportunities. But those kind of follow a slightly less rigorous pathway.

我要補充的一個警告是，其中一些，還有另一種選擇，其中一些非常罕見的兒科疾病，你不一定要經歷相同的範圍。所以它可能會有所不同——到 2024 年實際上可能會有一些藥物商業化，儘管有一些更小的、罕見的疾病機會。但是那些遵循稍微不那麼嚴格的途徑。

Got it. Okay. That's helpful. Maybe switching over to the laser to get a little color there. You've previously spoken to a concept of 100, 100, 100 systems each doing 100 procedures at, call it, on average 10,000 per procedure, making for a $100 million revenue business. Maybe speak to the lasers specific contribution to that equation and how impactful that the launch and scaling of the laser can be?

知道了。好的。這很有幫助。也許切換到激光在那裡獲得一點顏色。您之前已經談到了 100、100、100 個系統的概念，每個系統執行 100 個程序，平均每個程序 10,000 個，創造 1 億美元的收入業務。也許談談激光器對該方程式的具體貢獻以及激光器的發射和縮放可以產生多大的影響？

Yes, I think it will be a very important launch for us. Again, we're not trying to kind of overpromise the speed at which we're going to go. One thing to consider in our clearance CLS got with the FDA around Prism is that the first clearance is actually only for 3 Tesla scanners. It does not yet include the 1.5 Tesla, so that's about half of our customers that are on the 3T magnet and sort of where we're starting first. We would expect the 1.5 [Tesla] approved probably early 2024, I think, is realistic. But that's why we're going to be operating in a little bit longer of a limited market release.

是的，我認為這對我們來說將是一次非常重要的發布。同樣，我們並沒有試圖過分承諾我們要走的速度。在我們的 CLS 與 FDA 就 Prism 取得的許可中需要考慮的一件事是，第一個許可實際上僅適用於 3 台特斯拉掃描儀。它還不包括 1.5 特斯拉，所以我們大約有一半的客戶使用 3T 磁鐵，這也是我們首先開始的地方。我們預計 1.5 [Tesla] 可能會在 2024 年初獲得批准，我認為這是現實的。但這就是為什麼我們將在有限的市場發布中運行更長的時間。

But if we can get to the point where we're opening kind of new -- a couple of sites each quarter and trial and getting some ramp and some stickiness with the technology, if you think about the next 15 months, that's kind of the speed which we hope to go to.

但是，如果我們能夠達到這樣的程度，即我們每個季度都會開設一些新站點並進行試用，並獲得一定程度的提升和對技術的粘性，如果您考慮接下來的 15 個月，那就是我們希望達到的速度。

If you fast forward into the future, and you think about your question, which was the contribution to when we're a $100 million business, how much of that is laser and laser navigation, I think this could easily be a 1/4 of that number. So probably 25% of that is sort of what we would expect, ballpark, which it could go faster, it could go slower based on what our biologics business does, but we're counting on this to be a meaningful part of our equation and an important part of our business.

如果你快進到未來，想想你的問題，當我們的業務達到 1 億美元時，其中有多少是激光和激光導航，我認為這很容易是 1/4那個數字。所以可能其中的 25% 是我們所期望的，大概，根據我們的生物製劑業務的情況，它可能會更快，也可能會更慢，但我們指望這是我們等式中有意義的一部分，並且我們業務的重要組成部分。

We have no more questions at this time.

我們現在沒有問題了。

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

好的。好吧，再次感謝所有有興趣加入我們團隊在 ClearPoint 的旅程的人。我們認識到我們今天都被迫生活在充滿挑戰的全球環境中。我們向您保證，我們將竭盡全力幫助世界各地的患者，保持低調、專注並執行我們的戰略，開發真正改善患者及其家人生活質量的產品。

As management, we will react quickly and thoughtfully to future challenges, which we realize are always around the corner. Good night, everyone.

作為管理層，我們將對未來的挑戰做出迅速而深思熟慮的反應，我們意識到這些挑戰總是指日可待。各位晚安。

Ladies and gentlemen, this concludes your call. You may disconnect at this time. Once again, this concludes your call, and you may disconnect at this time.

女士們，先生們，你們的電話到此結束。此時您可以斷開連接。再一次，這結束了你的通話，此時你可以斷開連接。