Clearpoint Neuro Inc (CLPT) 2024 Q3 法說會逐字稿

Greetings and welcome to the ClearPoint Neuro, Inc., third-quarter 2024 financial results conference call. (Operator Instructions) As a reminder, this conference is being recorded.

各位來賓，歡迎參加 ClearPoint Neuro, Inc. 2024 年第三季財務業績電話會議。（操作說明）提醒各位，本次會議正在錄音。

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.

本次電話會議中的評論可能包含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產業趨勢相關的陳述。

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 revenue, results of operations or the adequacy of cash and cash equivalent balances to support operations and meet future obligations.

公司的計劃、前景和策略，包括初步的和預測的，總潛在市場規模或公司產品和服務的市場機會，以及管理層對未來收入、經營業績或現金及現金等價物餘額是否足以支持營運和履行未來義務的預期、信念、估計或預測。

Actual results or trends could differ materially. The company undertakes no obligation to revise forward-looking statements for new information or future events.

實際結果或趨勢可能與此有重大差異。本公司不承擔因新資訊或未來事件而修改前瞻性聲明的義務。

For more information, please refer to the company's annual report on Form 10-K for the year ended December 31 2023 and the company's quarterly report on Form 10-Q for the three months ended June 30, 2024. Both of which have been filed with the securities and Exchange commission and the company's quarterly report on Form 10-Q for the three months ended September 30, 2024, which the company intends to file with the securities and exchange commission on or before November 14, 2024.

有關更多信息，請參閱公司截至 2023 年 12 月 31 日止年度的 10-K 表格年度報告以及公司截至 2024 年 6 月 30 日止三個月的 10-Q 表格季度報告。這兩份文件均已提交給美國證券交易委員會，本公司截至 2024 年 9 月 30 日止三個月的季度報告（10-Q 表格）也已提交給美國證券交易委員會，公司計劃於 2024 年 11 月 14 日或之前提交給美國證券交易委員會。

All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com.

可從美國證券交易委員會或公司網站 www.clearpointneuro.com 取得該公司的所有文件。

And now I would like to turn the call over to Joe Burnett, President and CEO. Please go ahead sir.

現在，我想把電話交給總裁兼執行長喬·伯內特。請繼續，先生。

Thank you and thank you to all of the investors and analysts on today's call for being a part of the ClearPoint neuro vision and journey.

感謝各位，也感謝今天參加電話會議的所有投資者和分析師，感謝你們成為 ClearPoint 神經願景和發展歷程的一部分。

Our mission and our priority is to help restore quality of life to patients and their families who are suffering from some of the some of the most debilitating neurological disorders imaginable.

我們的使命和首要任務是幫助患有某些最嚴重的神經系統疾病的患者及其家人恢復生活品質。

In the third-quarter of 2024 the entire ClearPoint Neuro team contributed to a record revenue quarter of $8.1 million. And in our view, the strongest financial and strategic performance in our history.

2024 年第三季度，ClearPoint Neuro 的整個團隊為該公司創造了創紀錄的季度收入 810 萬美元。在我們看來，這是我們歷史上最強勁的財務和策略表現。

We made significant progress across all four of our growth pillars including number one, biologics and drug delivery. Number two, neurosurgery, navigation, number three, therapy and access products and number four, in achieving global scale.

我們在所有四大成長支柱領域都取得了顯著進展，其中生物製劑和藥物傳遞是第一大支柱。第二，神經外科、導航；第三，治療和輔助產品；第四，實現全球規模。

As we commented on our last earnings call, we are beginning to see the return on the investments. We made over the past three years in the form of growth across all four of our pillars and not only biologics and drug delivery, we are thrilled to report that all four of our growth pillars grew more than 20% in the third quarter with each segment contributing to the overall top line results. While at the same time, achieving scale and continuing our reduction in operational cash burn and that continued from the second quarter, we believe we have entered an exciting next phase of ClearPoint Neuro.

正如我們在上次財報電話會議上所說，我們開始看到投資回報了。過去三年，我們在所有四大支柱業務領域都取得了成長，不僅僅是生物製劑和藥物傳輸領域。我們很高興地宣布，第三季我們所有四大成長支柱業務的成長都超過了 20%，每個業務部門都為整體營收成長做出了貢獻。同時，隨著規模的擴大和營運現金消耗的持續減少（這一趨勢從第二季度延續至今），我們相信 ClearPoint Neuro 已經進入了一個令人興奮的新階段。

We have gone beyond being just an MRI navigation focused company. We have added operating room navigation with SmartFrame OR we have added our own laser therapy solution with prism. We have added significant preclinical services to support early partnership with BioPharma and we continue to see progress with our cell and gene therapy partners through the clinical and regulatory pathways to commercial approval on a global basis.

我們已不再只是一家專注於核磁共振導航的公司。我們增加了具有 SmartFrame 的手術室導航系統，或者我們增加了我們自己的帶有棱鏡的雷射治療解決方案。我們增加了重要的臨床前服務，以支持與生物製藥公司的早期合作，我們繼續看到我們的細胞和基因治療合作夥伴透過臨床和監管途徑在全球範圍內取得商業批准的進展。

The first of such gene therapy approvals has the potential of FDA clearance in the months ahead. We are very excited about how these new products and initiatives are performing in the field as well.

首個核准的此類基因療法預計在未來幾個月內獲得美國食品藥物管理局 (FDA) 的批准。我們對這些新產品和新措施在實際應用中的表現也感到非常興奮。

I will now turn the call over to Danilo, our CFO to review our financial performance in the quarter after which I will add some detail to our four pillar growth strategy. Danilo.

現在我將把電話交給我們的財務長達尼洛，讓他回顧本季的財務業績，之後我將詳細介紹我們的四大支柱成長策略。達尼洛。

Thank you, Joe, and thank you, ladies and gentlemen for joining us today. Looking at the third-quarter, 2024 results total revenue was $8.1 million for the three months ended September 30, 2024. In comparison to $5.8 million for the three months ended September 30, 2023 which represents an acceleration to 41% growth versus the third-quarter of 2023, and the fourth-quarter in a row of growth above 30%.

謝謝你，喬，也謝謝各位女士、先生今天蒞臨現場。從 2024 年第三季業績來看，截至 2024 年 9 月 30 日的三個月內，總收入為 810 萬美元。與截至 2023 年 9 月 30 日的三個月的 580 萬美元相比，增速加快至 41%，與 2023 年第三季相比，也是連續第四個季度增速超過 30%。

As a reminder, our revenue is made up of three components, biologics and drug delivery, neurosurgery, navigation and therapy, and capital equipment and software.

再次提醒，我們的收入由三個部分組成：生物製劑和藥物傳輸、神經外科、導航和治療以及資本設備和軟體。

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 grew 27% or $4.4 million in the third quarter. Up from $3.5 million in 2023.

生物製劑和藥物輸送收入包括一次性產品和服務的銷售，這些產品和服務與客戶贊助的臨床前和臨床試驗相關，並使用我們的產品。第三季度，生物製劑和藥物輸送收入成長了 27%，即 440 萬美元。比 2023 年的 350 萬美元有所增加。

This increase was fueled by a 353% increase in biologics and drug delivery product revenue. As our pharmaceutical customers progress in their preclinical and clinical trials.

這一成長主要得益於生物製劑和藥物輸送產品收入成長了 353%。隨著我們的製藥客戶在臨床前和臨床試驗中取得進展。

The biologics and drug delivery product growth was partially set by $0.7 million decrease in service revenue.

生物製劑和藥物輸送產品成長的部分原因是服務收入減少了 70 萬美元。

Neurosurgery navigation therapy revenue consists of commercial sales of disposable products related to ClearPoint navigation system. Our SmartFrame OR product and Prism Laser therapy disposables. This revenue segment grew 49% to $2.9 million for the third quarter as we activated new accounts and expanded the introduction of SmartFrame OR and the prism Laser therapy.

神經外科導航治療收入包括與 ClearPoint 導航系統相關的耗材的商業銷售。我們的 SmartFrame OR 產品和 Prism 雷射治療耗材。第三季度，隨著新帳戶的啟動和 SmartFrame OR 及棱鏡雷射療法的推廣，該收入板塊增長了 49%，達到 290 萬美元。

Capital equipment and software revenue consists of sales of ClearPoint neuro navigation hardware and software and the Prism Laser system and of services increased 133% to $0.8 million in the third quarter from $0.4 million for the same period in 2023. Gross margin for the third quarter, 2024 was 60% as compared to a gross margin of 57% for the third-quarter of 2023.

資本設備和軟體收入包括 ClearPoint 神經導航硬體和軟體以及 Prism 雷射系統的銷售額，以及服務收入，第三季成長 133%，達到 80 萬美元，而 2023 年同期為 40 萬美元。2024 年第三季的毛利率為 60%，而 2023 年第三季的毛利率為 57%。

The increase in gross margin was primarily due to an increase in volume and lower costs related to the transition of our manufacturing facility. In 2023, research and development costs were $3.3 million for the three months ended, September 30, 2024, compared to $2.4 million for the same period in 2023, an increase of $0.9 million or 36%. The increase was due primarily to an expansion of our research and development initiatives and investments in further innovation.

毛利率的成長主要是由於產量增加以及生產設施轉型帶來的成本降低。2023 年截至 2024 年 9 月 30 日的三個月內，研發費用為 330 萬美元，而 2023 年同期為 240 萬美元，增加了 90 萬美元，增幅達 36%。成長主要歸功於我們擴大了研發計劃並加大了對進一步創新的投資。

Sales and marketing expenses were $3.5 million for the third quarter compared to $2.8 million for the same period in 2023 an increase of $0.7 million or 25%.

第三季的銷售和行銷費用為 350 萬美元，而 2023 年同期為 280 萬美元，增加了 70 萬美元，增幅達 25%。

This increase was mainly due to additional personnel costs as we expand our commercial reach to support and accelerate our product launches.

這一成長主要是由於我們擴大商業範圍以支援和加速產品發布而產生的額外人員成本。

General administrative expenses were $3.2 million for the third quarter compared to $2.9 million for the same period in 2023 an increase of $0.3 million or 9%. This increase was mostly due to higher headcount costs with respect to our cash position. As of September 30, 2024, we held cash and cash equivalents of $21.6 million compared to $32.8 million as of June 30, 2024.

第三季一般行政費用為 320 萬美元，而 2023 年同期為 290 萬美元，增加了 30 萬美元，增幅為 9%。這一增長主要是由於相對於我們的現金狀況而言，人力成本增加所致。截至 2024 年 9 月 30 日，我們持有現金及現金等價物 2,160 萬美元，而截至 2024 年 6 月 30 日，這一數字為 3,280 萬美元。

In August 2024 we proceeded with an early repayment of the entire principal and interest outstanding on our existing convertible loan for a total amount of $10.1 million.

2024 年 8 月，我們提前償還了現有可轉換貸款的全部未償本金和利息，總額為 1,010 萬美元。

As of September 30, 2024, we have no outstanding debt in line with the prior quarters. We continue to meaningfully reduce our operational cash burn.

截至 2024 年 9 月 30 日，我們與前幾季一樣，沒有任何未償債務。我們持續大幅降低營運現金消耗。

Our operational cash burn in Q3 was down to $1.2 million, a 33% reduction from the prior year's third quarter in the past trailing 12 months, our operational cash burn was $8.9 million. This represents a 43% reduction compared to the corresponding prior 12 month period that is from October 2022 to September 2023.

第三季我們的營運現金消耗降至 120 萬美元，比去年同期減少了 33%；過去 12 個月，我們的營運現金消耗為 890 萬美元。與 2022 年 10 月至 2023 年 9 月的相應前 12 個月相比，這相當於減少了 43%。

With that I'd like now to turn the call back to Joe.

現在我想把電話轉回喬。

Thanks, Danilo, as mentioned previously, 2024 continues to be a great year of execution with a 38% year over year-to-date increase in revenue. A 39% reduction in operational cash burn multiple new product launches, additional long term pharma partnerships, global expansion of our portfolio and a strong cash position with a debt free balance sheet. As always, let's break that progress down into our four growth pillars.

謝謝 Danilo，如同先前所提到的，2024 年繼續保持良好的執行力，營收年增 38%。營運現金消耗減少 39%，推出多項新產品，建立更多長期製藥合作夥伴關係，在全球擴展產品組合，以及擁有強勁的現金狀況和無債務的資產負債表。像往常一樣，讓我們把這項進展分解為四大成長支柱。

Starting with pillar number one, biologics and drug delivery. We had a terrific quarter on numerous fronts.

首先從第一支柱－生物製劑和藥物傳遞開始。我們在很多方面都取得了非常出色的成績。

Let's talk about four recent key milestones in our gene and cell therapy business. First, as Danilo mentioned, we saw a significant increase in actual product sales to pharma partners. This is very important as it shows the progression of our partners who are advancing along the regulatory pathway.

讓我們來談談我們基因和細胞治療業務近期的四個重要里程碑。首先，正如 Danilo 所提到的，我們看到實際產品銷售額向製藥合作夥伴大幅成長。這非常重要，因為它展現了我們的合作夥伴在監管路徑上的進展。

Our early engagement with pharma is normally heavily weighted towards service revenue. We begin with strategy discussions, discovery consultancy, pilot studies and benchtop testing which generally have limited product sales and higher service sales.

我們早期與製藥公司的合作通常著重於服務收入。我們首先進行策略討論、探索性諮詢、試點研究和桌上型測試，這些通常產品銷售有限，但服務銷售較高。

Later in the engagement, we generally move into supporting non-clinical studies, clinical trials, post procedural data analysis and eventually commercialization where the partners or the hospital is purchasing actual navigation and infusion products.

在合作後期，我們通常會轉而支持非臨床研究、臨床試驗、術後數據分析，並最終實現商業化，屆時合作夥伴或醫院將購買實際的導航和輸液產品。

This is where we see product sales to BioPharma, generally outpace service sales and demonstrates the continued progression of our partners through this regulatory process.

在這裡，我們看到生物製藥行業的產品銷售額通常超過服務銷售額，這表明我們的合作夥伴在這一監管過程中不斷取得進展。

Second, we have now seen multiple partners selected for various accelerated FDA pathways designed to speed the clinical trial execution and eventual regulatory approval of these new to world cell and gene therapies often referred to as regenerative therapies.

其次，我們現在已經看到多個合作夥伴被選中參與各種加速的 FDA 審批途徑，旨在加快臨床試驗的執行，並最終獲得這些世界新出現的細胞和基因療法（通常被稱為再生療法）的監管批准。

We now have seven partnered programs that have been designated as either fast track priority review or [RMAT], which highlights the importance that the FDA has placed on the entire cell and gene therapy market. And the recognition of the life altering impact that these drugs may have to patients. While there's never a guarantee of timeline or approval, it is very reassuring and exciting that the FDA has created these accelerated pathways and that many of our partners have demonstrated significant enough progress and clinical results to be eligible for these programs in the first place.

我們現在有七個合作項目被指定為快速通道優先審查或[RMAT]，這凸顯了FDA對整個細胞和基因治療市場的重視。並認識到這些藥物可能對患者的生活產生改變性的影響。雖然永遠無法保證時間表或批准，但令人非常欣慰和興奮的是，FDA 已經創建了這些加速審批途徑，而且我們的許多合作夥伴已經取得了足夠的進展和臨床結果，從而有資格參與這些計畫。

In total, if we added together all of the indications that are now included in these expedited programs alone, the total patient prevalence is measured in the millions of patients globally.

總而言之，如果我們把目前這些快速通道計畫中包含的所有適應症加起來，全球患者總數就高達數百萬。

Third, we continue to make progress, expanding our pre-clinical services and capacity with the next stage goal to be GLP ready and to commence with our initial ClearPoint driven G LP studies. Later in 2025 our team continues to feel confident in the demand for our products and services as well as our unique expertise.

第三，我們不斷取得進展，擴大了我們的臨床前服務和能力，下一階段的目標是達到 GLP 標準，並開始我們最初的 ClearPoint 驅動的 GLP 研究。2025 年下半年，我們的團隊仍然對我們的產品和服務以及我們獨特的專業知識的需求充滿信心。

We believe in our ability to execute larger studies under GLP compliant procedures and facilities in the very near future.

我們相信，在不久的將來，我們有能力在符合GLP規範的程序和設施下進行更大規模的研究。

This further evolution of our drug delivery business will continue to expand not just in the value that we provide but also in the potential to build even stronger and earlier long term structured relationships with the pharmaceutical industry through the continuum of services.

我們的藥物輸送業務的進一步發展不僅體現在我們提供的價值上，還體現在透過連續性服務與製藥業建立更牢固、更早的長期結構化關係的潛力上。

And fourth, speaking of those relationships with pharma, we are excited to share that we have now executed strategic agreements across all of our desired frameworks. Proving that we do in fact provide unique capabilities that are valued by the cell and gene therapy community. These frameworks also demonstrate our creativity and our flexibility on how we can collaborate based on the needs of each individual BioPharma partner.

第四，說到與製藥公司的關係，我們很高興地宣布，我們現在已經在所有我們期望的框架內簽署了戰略協議。這證明我們確實提供了細胞和基因治療領域重視的獨特能力。這些框架也展現了我們的創造力和靈活性，使我們能夠根據每個生物製藥合作夥伴的具體需求進行合作。

We obviously cannot provide specific individual pricing or confidential strategic information. But what I can share is that we have now successfully signed agreements representing four different revenue structures and sometimes a combination of all four.

我們顯然無法提供具體的個別定價或機密戰略資訊。但我可以透露的是，我們現在已經成功簽署了代表四種不同收入結構的協議，有時會簽署所有四種收入結構的組合協議。

These can be number one, co-development where a partner pays a development fee and development milestones to ClearPoint for the custom development of a delivery device or software that will be used in their pre-clinical and clinical trials.

第一種可能是合作開發，即合作夥伴向 ClearPoint 支付開發費和開發里程碑款項，用於為其臨床前和臨床試驗客製開發輸送設備或軟體。

Number two, commercial pricing where a partner intends to provide their drug once FDA approved in a kit with the ClearPoint neurotechnology to simplify the commercial delivery of the product and purchase the devices directly from ClearPoint. Instead of ClearPoint neuro selling the product to hospitals, the commercial pricing is at a premium when compared to non-clinical and clinical trial device pricing.

第二，商業定價是指合作夥伴打算在藥物獲得 FDA 批准後，將其與 ClearPoint 神經技術一起作為試劑盒提供，以簡化產品的商業交付，並直接從 ClearPoint 購買設備。ClearPoint neuro 並沒有將產品直接賣給醫院，而是採用商業定價，與非臨床和臨床試驗設備定價相比，其定價較高。

Number three, clinical milestones whereby ClearPoint neuro receives cash payments upon progression of a therapy through its regulatory pathway. For example, approval of an IDE or IND study granted by the FDA or the first patient enrolled in a trial. Importantly, these milestones can happen during the drug discovery and regulatory process and do not have to take place at the very end with a commercial approval and finally a royalty payment to ClearPoint Neuro on the drug itself based on commercial sales of the gene or cellar gene therapy, which is delivered using ClearPoint delivery devices.

第三，臨床里程碑，ClearPoint neuro 在療法透過其監管途徑取得進展後獲得現金付款。例如，FDA 批准 IDE 或 IND 研究，或第一個患者入組試驗。重要的是，這些里程碑可以在藥物發現和監管過程中實現，而不必等到最後獲得商業批准，也不必最終根據基因或細胞基因療法的商業銷售向 ClearPoint Neuro 支付藥物本身的特許權使用費，而這些療法是透過 ClearPoint 輸送裝置進行的。

As a reminder, while not assured, we believe it is likely that these new two world drugs will be approved as combination devices with the ClearPoint Neuro cannulas and catheters, as we have seen in the European Union for the very first neuro gene therapy approved, our company therefore becomes an essential supplier to our pharma partners.

再次提醒大家，雖然不能保證，但我們相信這兩種新的世界藥物很可能會像歐盟批准的首個神經基因療法那樣，作為與 ClearPoint Neuro 插管和導管的組合設備獲得批准。因此，我們公司將成為我們製藥合作夥伴的重要供應商。

As a result, our partners are looking for very long term agreements, assurances of supply access to ClearPoint Neuro's unique intellectual property, redundancy of manufacturing and even more. It is this long term need and partnership that puts us in a unique position to earn increased future revenues for our products and services. Beyond simply the price of a single disposable device.

因此，我們的合作夥伴正在尋求非常長期的協議、ClearPoint Neuro獨特智慧財產權的供應保證、冗餘的生產方案等等。正是這種長期需求和合作關係，使我們處於獨特的地位，能夠為我們的產品和服務贏得更多未來的收入。不僅僅是單一一次性設備的價格。

Moving on to pillar number two, which is neurosurgery navigation. We saw continued and accelerated customer site activations and product sales in the quarter fueled by both placements of our traditional MRI guided navigation system as well as the continuation of the full market release of our SmartFrame OR operating room system designed for use with CT scanners in the operating room.

接下來是第二大支柱，即神經外科導航。本季度，客戶現場活化和產品銷售持續加速成長，這得益於我們傳統的 MRI 導引導航系統的部署，以及專為與手術室 CT 掃描儀配合使用而設計的 SmartFrame OR 手術室系統的全面市場發布。

We have also seen two very exciting developments in the DBS space that took place in the third quarter. First, Medtronic got approval or approved labelling for asleep DBS procedures based on the wealth of compelling clinical evidence that excellent outcomes are achieved when the patient is comfortably asleep versus awake for these DBS procedures. This new labelling will allow a large company like Medtronic to begin educating patients on the technique which was not possible without this new FDA labelling historically.

我們也看到星展銀行領域在第三季出現了兩個非常令人興奮的發展。首先，美敦力公司獲得了睡眠狀態下進行 DBS 手術的批准或批准標籤，這是基於大量令人信服的臨床證據，這些證據表明，與清醒狀態下進行 DBS 手術相比，患者在舒適睡眠狀態下進行 DBS 手術可取得極佳的療效。這項新的標籤將使像美敦力這樣的大公司能夠開始向患者普及這項技術，如果沒有這項新的 FDA 標籤，這在歷史上是不可能的。

Second, Abbott has announced that the Transcend study which is designed to study the use of DBS to treat severe depression well, while it will likely take years before this new indication is achieved, the transcend study itself will enroll 100 patients. And many of the participating centers have communicated to us that they plan to use ClearPoint technology as their preferred navigation system. This will allow ClearPoint to participate in these trial patients and also be involved from the very beginning of this new indication.

其次，雅培公司宣布，旨在研究使用 DBS 治療重度憂鬱症的 Transcend 研究正在進行中。雖然要實現這項新適應症可能還需要數年時間，但 Transcend 研究本身將招募 100 名患者。許多參與中心都向我們表示，他們計劃使用 ClearPoint 技術作為其首選導航系統。這將使 ClearPoint 能夠參與這些試驗患者，並從一開始就參與這項新適應症的研究。

As a reminder, we have historically activated approximately 6 to 8 new customers each year, with the 5 that we added here in the third quarter that brings our total up to 19 for this year. And actually more than 20 at the time of this earnings call. These accelerated placements have helped fuel not only our disposable product sales, which we'll talk about in a second but also capital rental and service sales, which more than doubled versus a year ago, we had communicated an earlier goal of achieving 100 global activated sites by the end of 2025. But given this new pace of placements. We believe we will achieve 100 by the first half of 2025. If not sooner.

提醒一下，我們歷來每年都會啟動大約 6 到 8 個新客戶，加上第三季新增的 5 個客戶，今年的總客戶數達到了 19 個。截至本財報電話會議時，實際數字已超過 20。這些加速部署不僅推動了我們的一次性產品銷售（我們稍後會談到），也推動了資本租賃和服務銷售（與一年前相比增長了一倍多）。我們先前曾宣布，到 2025 年底，我們的目標是在全球啟動 100 個站點。但鑑於這種新的招募節奏。我們相信到 2025 年上半年將達到 100 人。如果不是更快的話。

Next, let's move on to pillar number three, which is the therapy and access products. In the second quarter, we obtained FDA clearance for the Prism anchor bolt accessory which has opened the door for use of our Prism Laser system with some existing robotic systems at sites that prefer to use robotic navigation in place of our ClearPoint navigation.

接下來，我們來看第三大支柱，即治療和獲取產品。第二季度，我們獲得了 FDA 對 Prism 錨栓配件的批准，這為我們的 Prism 雷射系統與一些現有的機器人系統在一些場所的使用打開了大門，這些地方更傾向於使用機器人導航而不是我們的 ClearPoint 導航。

Here in the third quarter, we released new product packaging and compatibility with third party anchoring mechanisms that can help us to get access to hospitals quicker by not needing to put additional new ancillary devices through the hospital's vac approval process.

在第三季度，我們推出了新的產品包裝，並與第三方固定機制相容，這可以幫助我們更快地進入醫院市場，而無需將額外的輔助設備通過醫院的 VAC 審批流程。

These new releases may seem simple but they are important steps to adoption and they show our customers that we are listening to their feedback, iterating quickly and doing everything we can to make adoption of prism fit comfortably into their existing hospital workflow with as few changes as possible.

這些新版本看似簡單，但卻是推廣應用程式的重要步驟，也向我們的客戶表明，我們正在傾聽他們的回饋，快速迭代，並盡一切努力使 Prism 的採用能夠盡可能少地改變他們現有的醫院工作流程，從而讓他們感到舒適。

While we do remain somewhat limited to about half of the laser market today. As our system is currently only approved for three Tesla scanners. We are there are plenty of target hospitals to keep us busy while we develop the regulatory pathway for 1.5 Tesla scanner approval, which we do anticipate becoming available in 2025.

雖然我們目前仍然只佔雷射市場的一半左右。因為我們的系統目前僅獲準用於三款特斯拉掃描器。我們有許多目標醫院可以讓我們忙於制定 1.5 特斯拉掃描器的監管審批途徑，我們預計該掃描器將於 2025 年上市。

We are also making significant progress toward being able to commercialize an MRI conditional power drill, which we believe will be a powerful complement to our therapy and access products. This tool developed by our partner OFAC Medical is designed to provide significantly faster access for surgeons than our current hand drill and has the potential to meaningfully reduce procedure times once development is finalized and the drill is ready for commercialization. ClearPoint Neuro will be the exclusive worldwide distributor for this new product.

我們在實現 MRI 相容型電動鑽孔的商業化方面也取得了重大進展，我們相信這將有力地補充我們的治療和輔助產品。我們的合作夥伴 OFAC Medical 開發的這款工具旨在為外科醫生提供比我們目前的手鑽更快的操作速度，並且一旦開發完成且鑽頭準備好商業化，就有可能顯著縮短手術時間。ClearPoint Neuro將成為這款新產品的全球獨家經銷商。

Now that, when we report numbers for neurosurgery navigation and therapy, we bucket them together into medical device disposables. As Danilo mentioned, this segment grew 49% in the quarter and is again driven by from three disposable revenue sources, MRI navigation, operating room navigation and laser therapy.

現在，當我們報告神經外科導航和治療的數據時，我們會將它們歸類為醫療器械耗材。正如 Danilo 所提到的，該業務板塊在本季度增長了 49%，再次受到三個可支配收入來源的推動，即 MRI 導航、手術室導航和雷射治療。

Overall. Our product sales once again, more than doubled versus a year ago, which has a positive impact on gross margin due to the increased throughput at our factory.

全面的。我們的產品銷售再次比去年翻了一番還多，由於工廠產量增加，這對毛利率產生了積極影響。

Finally, let's talk about pillar number four, which is in achieving global scale and profitability. This was another discipline quarter from a spending standpoint that saw 41% revenue growth while reducing operational cash burn down to only $1.2 million, which represents a 33% reduction versus Q3 of 2023.

最後，我們來談談第四個支柱，即實現全球規模和獲利能力。從支出角度來看，本季公司又維持了嚴格的紀律，營收成長了 41%，同時營運現金消耗減少到僅 120 萬美元，比 2023 年第三季減少了 33%。

We continue to believe that a cash flow break even quarter by the end of 2025 is possible and we feel that our strong cash position today with over $21.6 million in cash and cash equivalents and no debt on our balance sheet, by retiring our only outstanding debt in the quarter. We have significant optionality to service any future capital needs and we'll review our capital planning in the context of driving profitable growth.

我們仍然相信，到 2025 年底實現現金流收支平衡是可能的，我們認為，憑藉目前超過 2,160 萬美元的現金及現金等價物，以及資產負債表上沒有債務，我們能夠在本季度償還唯一未償債務，實現強勁的現金狀況。我們擁有充足的選擇權來滿足未來的任何資本需求，我們將根據實現獲利成長的目標來重新審視我們的資本規劃。

We continue to believe our revenue for the full year will fall between our previous guidance of $30 million to $33 million representing growth of between 25% and 38% for the full year.

我們仍然相信，全年營收將達到先前預期的 3,000 萬美元至 3,300 萬美元，年增 25% 至 38%。

With that, I will now open up the call to any questions.

接下來，我將開放提問環節。

(Operator Instructions)

（操作說明）

Matt Blackman, Stifel.

馬特·布萊克曼，史蒂費爾。

Hi, this is Emily on for Matt. Congrats on the great quarter again. Looking to 2025, I understand there's no guidance today. But can you just call out some of the general headwinds tailwinds that should be on our radar, maybe any reflection points with the GLP or what have you?

大家好，我是艾米莉，替馬特為您報道。再次恭喜你們取得如此優異的季度業績。展望2025年，據我了解，目前還沒有任何指導方針。您能否指出一些我們應該關注的整體不利因素和有利因素，以及您對 GLP 或其他方面的任何反思要點？

Yeah, I mean, we're not quite prepared to get too far into 2025 Emily, as I think you pointed out. But you know, there's certainly some factors that I think are making us feel pretty good about our growth prospects. You know, from a practical standpoint, you know, we don't see any reason or any headwinds relative to market development or growth of the underlying surgeries. If anything, we expect more surgeries to take place next year, related to continued use of deep brain stimulation, the fact that as I mentioned earlier on the call Medtronic now has a clearance to be able to promote a sleep DBS.

是的，我的意思是，正如你所指出的，我們還沒有做好展望 2025 年的準備。但你知道，確實有一些因素讓我們對自身的發展前景感到非常樂觀。從實際角度來看，我們看不到任何與市場發展或相關手術成長有關的阻力或不利因素。如果有什麼變化的話，我們預計明年會有更多的手術進行，這與深部腦部刺激的持續使用有關，正如我之前在電話會議上提到的，美敦力現在已經獲得了推廣睡眠DBS的許可。

You know, there's a number of studies and publications that have shown that one of the primary reasons that patients are indicated for DBS, but don't go through with the procedure is because they find out that they would be awake during the procedure. And quite frankly, that's scary to many patients, you know, with this new indication companies like Medtronic, as well as the surgeons themselves can promote and educate these patients that there is in fact, another option which we believe is going to drive more patients to go through with the procedure.

你知道，有許多研究和出版物表明，患者適合接受 DBS 手術，但最終沒有接受手術的主要原因之一是他們發現自己在手術過程中會保持清醒。坦白說，這讓許多患者感到害怕，你知道，有了這種新的適應症，像美敦力這樣的公司以及外科醫生本身就可以向這些患者宣傳和教育他們，讓他們知道實際上還有另一種選擇，我們相信這將促使更多患者接受手術。

Coupled with the fact that there are a number of new indications for DBS around epilepsy, around OCD and new studied indications like I mentioned for severe depression that I we will grow those underlying markets. We've also heard positive, you know, results relative to demand for laser therapy, particular on the tumor side of things where hospitals have realized that if they do a number of laser procedures for tumor. The patients are generally discharged from the hospital in under 24 hours compared to two or even three days, sometimes with an open resection.

再加上 DBS 在癲癇、強迫症等方面有許多新的適應症，以及像我提到的重度憂鬱症等新的研究適應症，我們將擴大這些潛在市場。我們也聽到了一些關於雷射療法需求的正面消息，尤其是在腫瘤治療方面，醫院已經意識到，如果他們進行多次雷射腫瘤治療手術。與以往需要兩到三天，有時甚至需要進行開放式切除手術的患者相比，患者通常在 24 小時內即可出院。

So, you know, cleaning up these past procedures if you will including radiation necrosis and getting the patient out of that hospital bed in under 24 hours, so that a new patient can take their spot is something that's very attractive to these hospitals. So we do see them continuing to grow their position there. And then finally, the progress that we're seeing with a lot of our cell and gene therapy partners, you know, even if nothing is commercially approved yet, albeit the first one is on the horizon here, we hope the even the entry or the progression from zero patients to a safety study or from a phase one safety study into a Phase 2 and Phase 3, pivotal or combination study can drive significantly meaningful revenue to us as well.

所以，你知道，清理這些過去的醫療程序，包括放射性壞死，並在 24 小時內讓病人離開病床，以便新病人可以接替他們的位置，這對這些醫院來說非常有吸引力。因此，我們看到他們繼續擴大在該地區的地位。最後，我們看到與許多細胞和基因治療合作夥伴的合作取得了進展，你知道，即使目前還沒有任何產品獲得商業批准（儘管第一個產品即將面世），我們也希望即使是從零患者到安全性研究，或者從一期安全性研究到二期和三期關鍵性研究或聯合研究的進展，也能為我們帶來顯著的收入。

You know, to put in perspective, you know, we've seen clinical trial, Phase 2, Phase 3 protocols for things like Parkinson's disease, you know, which could be anywhere from 180 to 220 patients. So, you stack four or five of these studies on top of each other and that's pretty close to the total number of procedures we did in all of 2023, so these could be meaningful as well.

你知道，從這個角度來看，我們已經看到帕金森氏症等疾病的臨床試驗、第二期、第三期方案，你知道，這些方案可能涉及 180 到 220 名患者。所以，把四、五項這樣的研究疊起來，就和我們 2023 年全年進行的手術總數非常接近了，所以這些研究也可能有意義。

So, you know, we do see quite a bit of opportunity still, that, that I would think is tailwinds in the underlying markets, let alone the new technology that we're, we're advancing. The other thing I bring up that, you know, I've been asked about in the past as well is, you know, this past year, the company just barely missed the cut off relative to the Russell index, the Russell 2000. So as a result, a lot of our sort of index fund holders had to cycle out of the stock itself, which created a significant headwind.

所以，你知道，我們仍然看到很多機會，我認為這得益於基礎市場的順風，更不用說我們正在推進的新技術了。我還想提一下，過去也有人問過我這個問題，那就是，去年，該公司相對於羅素指數（羅素 2000 指數）而言，僅僅差一點就達到了入選標準。因此，許多指數型基金持有者不得不拋售股票，這造成了很大的不利影響。

And as you can tell from our market cap today, we would be very, very comfortably in that Russell qualifier for next year. So assuming nothing, you know, I think significant changes that tailwind we saw in 2024 could become a, I'm sorry, the headwind that we saw in 2024 could be a tailwind for our stock in 2025. And, you know, we just have to do everything we can to continue to execute between now and then.

從我們今天的市值可以看出，我們明年完全有能力獲得羅素指數的參賽資格。所以，假設一切順利，我認為我們在 2024 年看到的順風可能會變成，抱歉，我們在 2024 年看到的逆風可能會變成 2025 年對我們股票有利的順風。你知道，從現在到那時，我們必須盡一切努力繼續執行各項任務。

Okay, great. And just a follow up if I could up to, you know, 20 new placements today year-to-date. Is that a new normal? I mean, it has been, you know, 6, 8, 10 maybe, but should we be thinking more 2025 going forward?

好的，太好了。另外，如果可以的話，我想補充一點，今年到目前為止，今天新增了 20 個職位。這就是新的常態嗎？我的意思是，過去可能是 6 年、8 年、10 年，但我們是否應該多考慮 2025 年？

I would expect that the new normal for us is certainly in the double digits. I don't see us returning to a six to eight number. I'd say, you know, we're probably in very advanced conversations with at least 50 additional hospitals today and we're at least in some level of conversation with more than 100.

我預計，對我們來說，新的常態肯定是兩位數。我不認為我們會回到六到八人的水平。我想說，我們今天可能正在與至少 50 家醫院進行非常深入的洽談，並且至少與 100 多家醫院進行某種程度的洽談。

So, I think there's plenty of room for us to grow, especially as we start to do more and more in the operating room. You know, one of the really one of the biggest things that held us back in the past was that so many hospitals would like to work with ClearPoint, that they simply did not have access to an MRI magnet. Maybe the magnet was owned by radiology or maybe, you know, certain certifications at the hospital would not allow a surgery to take place in the MRI.

所以，我認為我們還有很大的發展空間，尤其是在手術室裡進行越來越多的工作之後。你知道，過去阻礙我們發展的最大因素之一是，許多醫院都想與 ClearPoint 合作，但他們根本沒有 MRI 磁鐵。也許磁鐵屬於放射科所有，或者，你知道，醫院的某些認證不允許在核磁共振成像儀上進行手術。

So we were completely shut out of those hospitals. And that's simply not the case anymore now that we can launch our technology into just an everyday operating room with equipment like CT scanners and interoperative CTS that are readily available for any one of those centers.

所以，我們完全被那些醫院拒於門外。現在情況已經完全不同了，我們可以將我們的技術應用到日常手術室中，CT 掃描儀和術中 CTS 等設備可供任何一個中心隨時使用。

Great, great. Okay. Thank you very much.

太好了，太好了。好的。非常感謝。

Yeah, thanks Emily.

謝謝你，艾米麗。

(Operator Instructions)

（操作說明）

Frank Takkinen, Lake Street Capital.

塔基寧（Frank Takkinen），湖街資本公司。

Great. Thanks for taking the questions. Congrats on all the progress. Let's follow up on the last line of questioning a little bit on the new system activations. Can you maybe parse out which or how many of those or how many year-to-date are just SmartFrame OR activations? And just how much I know you touched on that a little bit in the tailwind, but just how much that has contributed to the new activation and then where that disposable revenue can go.

偉大的。謝謝您回答問題。祝賀你們取得的所有進展。讓我們稍微跟進一下上一個問題，關於新系統的啟動情況。能否具體指出其中哪些是 SmartFrame 或啟動次數，或者今年迄今為止有多少次啟動？我知道你在順風中稍微提到了這一點，但這對新激活的貢獻有多大，以及可支配收入的去向。

Yeah, I'm happy to give you a couple of examples there. So, I would say I have to think of the exact number. It might be a little off, but the magnitude will be there. I believe of those 19 activations this year. I think only two or three of those we would count as new activations from or, and it doesn't mean that we're only using the OR product at three centers.

是的，我很樂意給你舉幾個例子。所以，我想我得好好想想確切的數字。可能略有偏差，但大致方向是對的。我相信今年這 19 次激活中的一部分。我認為其中只有兩三個可以被算作來自 OR 的新激活，但這並不意味著我們只在三個中心使用 OR 產品。

What it means is that we do not count a new activation if they were already using ClearPoint in the MRI and then they also added SmartFrame OR, we don't count that as a new activation. That's an existing customer that we're going deeper into that customer because we have additional complementary technology.

這意味著，如果他們已經在 MRI 中使用 ClearPoint，然後又添加了 SmartFrame，我們不會將其計為新的啟動。這是我們正在深入挖掘的現有客戶，因為我們擁有額外的互補技術。

So to directly answer your, your question, Frank, of those 19, I think it's three that the operating room enabled for us. So it shows you we really have quite a long way to go. We're absolutely just getting started. But I think that's also the nature of a limited market release. You, generally go to customers that are familiar with ClearPoint first to make sure that the product is doing exactly what it's supposed to before you go into, to sites that have had no, no experience if you will.

所以，弗蘭克，直接回答你的問題，在這 19 例中，我認為手術室為我們提供了 3 例手術。這說明我們還有很長的路要走。我們才剛起步。但我認為，這也是限量市場發行產品的固有特性。通常情況下，你會先去拜訪熟悉 ClearPoint 的客戶，以確保產品能夠完全按照預期運行，然後再去拜訪那些完全沒有經驗的網站。

The second part of your question, you know, it's kind of meaningful and a really, really important part as to where the disposables can go. You know, we had a webcast that was performed by Dr. Connor at the University of Oklahoma recently. And I think he's a very good example of what the potential here is. This is a, a surgeon whose hospital, the surgery group did not own the MRI magnet, it was owned by radiology.

你問題的第二部分，你知道，它很有意義，對於一次性用品的去向來說，是非常非常重要的一部分。你知道嗎，我們最近有一場由俄克拉荷馬大學的康納博士主持的網路直播。我認為他就是一個很好的例子，展現了這裡的潛力。這是一位外科醫生，他所在的醫院，也就是外科團隊，並不擁有核磁共振磁體，而是由放射科擁有。

So he had been able to negotiate about one day of magnet use every month. So even if he had 50 or 60 DVS procedures he wanted to do each year, he could only do about 10 to 12 with us because that's what he got the magnet time for.

因此，他得以協商每月使用磁鐵一天左右。所以即使他每年想做 50 或 60 例 DVS 手術，他也只能在我們這裡做 10 到 12 例，因為他只有這麼一點時間使用磁鐵。

Now that we've enabled him to use ClearPoint in any environment, either the MRI or the operating room. You know, we're routinely doing maybe four or even five a month with Dr. Connor. So you can put in perspective, you know, now we're not leaving 80% of his volume on the table because we were not in the operating room, we're now able to actually win and earn his business for that other 80% because he and the team have gotten familiar with the ClearPoint system and the MRI as well as the ClearPoint or so, if we can replicate that experience at a number of different centers, this is not, this technology is not only about going to new hospitals, but it's actually increasing utilization and same store sales at existing hospitals as well.

現在我們已經讓他能夠在任何環境下使用 ClearPoint，無論是在 MRI 室還是手術室。你知道，我們通常每個月會和康納醫生進行四到五次治療。所以你可以這樣理解，現在我們不會因為不在手術室就放棄他 80% 的業務量，我們現在能夠贏得他剩下的 80% 的業務，因為他和他的團隊已經熟悉了 ClearPoint 系統和 MRI，以及 ClearPoint 本身。如果我們能在多個不同的中心複製這種經驗，那麼這項技術的意義就不僅僅在於進入新的醫院，它實際上還能提高現有醫院的利用率和同店銷售額。

Got it, that's helpful. And then maybe one follow up directly on that again, how many of your 90 accounts have SmartFrame OR today?

明白了，這很有幫助。然後或許可以再直接追問一下，你們的 90 個帳號中，今天有多少個帳號擁有 SmartFrame OR？

I would say there's maybe six or seven or so give in that order of magnitude. And then I'd say there's another 10 or so accounts where we're, what I would say is in advanced conversations in front of the VAC committee.

我認為在這個數量級上，大概有六、七個機會。然後，我想說還有大約 10 個帳戶，我們正在就這些帳戶與 VAC 委員會進行深入討論。

So for those who are not familiar, the value analysis committee is a standard process of any hospital. You know, once anytime you have a new technology, you have to establish pricing, you have to show that it's got, you know, legs and benefit to the hospital, to the surgeon and certainly to the patient. So there's a review process that takes place. Sometimes the VAC committee meets every week, sometimes it meets once every three months. So you have to really get in line, get on the schedule and get going. But, you know, we have at least 10 of those committee meetings that are going on as we speak.

所以對於那些不熟悉的人來說，價值分析委員會是任何醫院的標準流程。你知道，每當你擁有一項新技術時，你必須確定價格，你必須證明它具有可行性，並且能夠為醫院、外科醫生以及患者帶來好處。所以會有一個審核流程。VAC委員會有時每週開會，有時每三個月開會一次。所以你必須認真排隊，按計劃行事，然後開始行動。但是，你知道，就在我們說話的時候，至少有 10 個這樣的委員會會議正在進行中。

Got it. And then last one for me, gross margins have trended favorably. How should we think about where gross margins can go with some of the new products in the bank.

知道了。最後一點，毛利率呈現良好趨勢。我們該如何看待銀行一些新產品的毛利率走向？

You know, from a disposable standpoint. You know, if we get to any meaningful scale at our Carlsbad facility, you know, there's no reason we can't be at 70% gross margin on the disposable side. And that includes cannulas as well for drug delivery trials that certainly involves Cannulas where they're not using our navigation at all.

你知道，從一次性用品的角度來看。你知道，如果我們卡爾斯巴德工廠的生產規模達到一定程度，那麼一次性用品的毛利率達到 70% 就完全有可能。這其中也包括用於藥物輸送試驗的套管，這些試驗肯定涉及套管，而他們根本沒有使用我們的導航系統。

You know, in some cases, there might be one Pharma customer that doesn't want to use our navigation, but they're going to use five or six of our cannulas. You know, that's a very profitable procedure for us because the cannula is it easier to make than the navigation frames.

你知道，在某些情況下，可能有一個製藥客戶不想使用我們的導航系統，但他們會使用我們的五到六個導管。你知道，這對我們來說是一個非常有利可圖的手術，因為套管比導航框架更容易製作。

The drag that sometimes we get quarter to quarter on the margin standpoint is really if we have a really good capital quarter, for example, you know, our capital margins of selling the head frames. You know, some components, for example, we don't make any money on.

從利潤率的角度來看，我們有時遇到的季度間拖累，實際上是如果我們有一個非常好的資本季度，例如，你知道，我們銷售頭架的資本利潤率。你知道，例如，有些零件我們根本賺不到錢。

They're just a necessary piece of equipment meant that the hospital needs to do the procedure from another vendor. So, you know, our margins are in that 35% to 45% range there. So it's not a bad deal for us. We actually still make money on that transaction. However, if you happen to have one quarter where we sell three or four systems like we did in the first quarter of this year, I think our, you know, our, our overall capital revenues is around $1.3 million or $1.4 million. You know, that can actually drag the total margin down a little bit just from a mix standpoint.

它們只是醫院需要從其他供應商購買的必要設備，用於進行手術。所以，你知道，我們的利潤率在 35% 到 45% 之間。所以這對我們來說不算是虧本買賣。實際上，我們從這筆交易中仍然能賺錢。但是，如果像今年第一季那樣，我們碰巧在一個季度內售出三到四套系統，我認為我們的總資本收入約為 130 萬美元或 140 萬美元。你知道，從產品組合的角度來看，這實際上可能會稍微拉低總利潤率。

But you know, when we get to scale and you know, you can imagine us doing $50 million, $60 million, $70 million of disposable revenue each year and capital revenue kind of staying flat. You know, our margins should be comfortably in the 70s at that point.

但你知道，當我們達到某個規模後，你可以想像我們每年能獲得 5000 萬美元、6000 萬美元、7000 萬美元的可支配收入，而資本收入基本上保持不變。你知道，到那時我們的利潤率應該可以輕鬆達到 70% 以上。

Got it. That's helpful. Thank you.

知道了。那很有幫助。謝謝。

Thanks, Frank.

謝謝你，弗蘭克。

There are no further questions at this time. I'd like to turn the call back to Joe Burnett, President and CEO of ClearPoint Neuro for any closing remarks.

目前沒有其他問題了。我想把電話轉回給 ClearPoint Neuro 的總裁兼執行長 Joe Burnett，請他作總結發言。

Once again, thank you to everyone interested in being a part of this team's journey here at ClearPoint. This is an exciting time as we plan for new product and service launches across all four of our growth pillars. We have worked hard to get to the spot and are and we are incredibly excited for our team, but also for the patients that we hope to treat with these new devices and therapies in the near future. The patient and their family is why we are here and ultimately who we are working for. Thank you and please have a good night.

再次感謝所有有興趣加入 ClearPoint 團隊並參與我們發展歷程的朋友們。這是一個令人興奮的時刻，因為我們計劃在所有四大成長支柱領域推出新產品和服務。我們付出了巨大的努力才走到今天，我們為我們的團隊感到無比興奮，也為我們希望在不久的將來用這些新設備和療法治療的患者感到興奮。病人及其家屬是我們存在的理由，也是我們最終為之工作的對象。謝謝，祝您晚安。

This concludes the ClearPoint Neuro third-quarter 2024 financial results conference call. Thank you for attending and have a wonderful rest of your day.

ClearPoint Neuro 2024 年第三季財務業績電話會議到此結束。感謝您的出席，祝您今天餘下的時間愉快。