Clearpoint Neuro Inc (CLPT) 2024 Q2 法說會逐字稿

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

您好，歡迎您參加 Clearpoint Neuro Inc 2024 年第二季財務業績電話會議。（操作員指示）謹此提醒，本次會議正在錄製中。

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, the size of the total addressable market 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.

本次電話會議的評論可能包括證券法意義內的前瞻性陳述。這些前瞻性陳述可能包括但不限於與預期行業趨勢、公司的初步和預期的計劃、前景和策略、總目標市場的規模或公司產品和服務以及管理層的市場機會相關的陳述。經營業績或現金和現金等價物餘額是否足以支持經營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. 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 March 31, 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 June 30, 2024, which the company intends to file with the Securities and Exchange Commission on or before August 14, 2024. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com.

實際結果或趨勢可能有重大差異。該公司不承擔因新資訊或未來事件而修改前瞻性陳述的義務。欲了解更多信息，請參閱公司截至2023年12月31日止年度的10-K表格年度報告以及截至2024年3月31日止三個月的公司10-Q表格季度報告，兩者均已向美國證券交易委員會提交的報告以及該公司截至2024年6月30日止三個月的10-Q表格季度報告，該公司計劃於2024年8月14日或之前向美國證券交易委員會提交該報告。本公司的所有文件均可從 SEC 或公司網站 www.clearpointneuro.com 取得。

And it is now my pleasure to introduce your host, Joe Burnett, Chief Executive Officer. Thank you, Joe. You may begin.

現在我很高興向您介紹主持人喬·伯內特（Joe Burnett），首席執行官。謝謝你，喬。你可以開始了。

Thank you, Morgan, 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.

謝謝摩根，也感謝今天呼籲參與 Clearpoint Neuro 願景和旅程的所有投資者和分析師。

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. In the second quarter of 2024, the entire Clearpoint Neuro team contributed to a record revenue quarter of $7.9 million and in our view, the strongest financial and strategic performance in our history. 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, achieving global scale.

我們的使命和首要任務是幫助患有一些最嚴重的神經系統疾病的患者及其家人恢復生活品質。2024 年第二季度，整個 Clearpoint Neuro 團隊貢獻了創紀錄的 790 萬美元季度收入，我們認為這是我們歷史上最強勁的財務和戰略業績。我們在所有四個成長支柱上都取得了重大進展，包括：第一，生物製劑和藥物輸送，第二，神經外科導航，第三，治療和接入產品，第四，實現全球規模。

Before we get started, I would like to frame the call by reminding everyone a bit about our history and why these four individual growth pillars are important. When we started our journey here at Clearpoint, we were reliant on just one of these four pillars, which was neurosurgery navigation. We were an MRI navigation company focused on guiding placement of deep brain stimulation lead, and that was about it. As leaders, we're always looking for that best analogy to help tell our story. Instead of pillars, maybe we should think about a growth engine.

在我們開始之前，我想透過提醒大家一些我們的歷史以及為什麼這四個單獨的成長支柱很重要來建構這次電話會議。當我們在 Clearpoint 開始我們的旅程時，我們只依賴這四大支柱之一，那就是神經外科導航。我們是一家 MRI 導航公司，專注於引導深部腦部刺激導線的放置，僅此而已。作為領導者，我們一直在尋找最好的類比來幫助講述我們的故事。也許我們應該考慮成長引擎，而不是支柱。

And back four years ago, we were essentially a one-cylinder engine. If that cylinder or piston was firing, then we were on the move. If anything happened to that one cylinder, we were stopped in our tracks as we saw at times in our history with COVID case cancellations and limited MRI access.

四年前，我們本質上還是一台單缸引擎。如果氣缸或活塞正在點火，那麼我們就在移動。如果那個氣缸發生任何事情，我們就會停下來，就像我們歷史上有時看到的那樣，因為新冠病例被取消，核磁共振成像檢查也受到限制。

As a team, we set out to improve the performance of this engine. We invested first in catheter and cannulas technology to focus on products for clinical trials sold directly to pharmaceutical partners. We added preclinical services to incorporate our technology into the drug discovery process and to build relationships with pharmaceutical companies well in advance of those first patients being treated.

作為一個團隊，我們致力於提高該引擎的效能。我們首先投資於導管和插管技術，專注於直接銷售給製藥合作夥伴的臨床試驗產品。我們增加了臨床前服務，將我們的技術納入藥物發現過程，並在第一批患者接受治療之前就與製藥公司建立關係。

We added laser therapy to control larger portions of the procedure and offer not only the surgical navigation, but also the therapy itself. We realized that MRI access can be a barrier at some hospitals. So we added technology to enable our platform to work not only in the MRI, but also in the operating room using CT as the primary imaging tool.

我們添加了雷射治療來控製手術的大部分，不僅提供手術導航，還提供治療本身。我們意識到 MRI 的取得可能會成為一些醫院的障礙。因此，我們添加了技術，使我們的平台不僅可以在 MRI 中工作，還可以在使用 CT 作為主要成像工具的手術室中工作。

We partnered with technology companies to build out unique software and artificial intelligence modeling capabilities to aid in precisely delivering therapeutics and also grow our installed base. We invested in regulatory submissions to expand access to our technology beyond the United States by growing into the European Union, Asia Pacific and other countries to further support the growing cell and gene therapy market.

我們與科技公司合作，開發獨特的軟體和人工智慧建模功能，以幫助精確提供治療方法並擴大我們的安裝基礎。我們投資了監管申請，透過擴展到歐盟、亞太地區和其他國家，將我們的技術擴展到美國以外的地區，以進一步支持不斷增長的細胞和基因治療市場。

We now feel that we have successfully added additional cylinders to our company's growth engine as our year-to-date 2024 results show. The expansion and increased depth of our products and services portfolio will not only help us accelerate our growth, but also allow us to diversify our revenue stream and reach more patients.

現在，正如我們 2024 年迄今為止的業績所顯示的那樣，我們現在認為我們已經成功地為公司的成長引擎增添了更多動力。我們產品和服務組合的擴展和深度增加不僅將幫助我們加速成長，而且使我們能夠實現收入來源多元化並覆蓋更多患者。

We are no longer that one cylinder engine, but rather a multicylinder engine that is ready for the next stage of our journey. What we have seen here in the second quarter has been the start of that next phase of Clearpoint where we are now seeing the contribution of all of these cylinders starting to ramp up and to propel us forward.

我們不再是那個單缸發動機，而是一台為下一階段旅程做好準備的多缸發動機。我們在第二季度看到的是 Clearpoint 下一階段的開始，我們現在看到所有這些氣缸的貢獻開始增加並推動我們前進。

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 additional detail to our four pillar growth strategy and expectations for the second half of 2024. Danilo?

我現在將把電話轉給我們的財務長達尼洛，回顧我們本季的財務業績，之後，我將為我們的四大支柱成長策略和 2024 年下半年的預期添加一些額外的細節。達尼洛？

Thank you, Joe, and good afternoon, everyone.

謝謝喬，大家下午好。

Looking at the second quarter 2024 results, total revenue was $7.9 million for the three months ended June 30, 2024, and $6 million for the three months ended June 30, 2023, which represents 32% growth versus the second quarter of 2023.

看看2024年第二季的業績，截至2024年6月30日的三個月的總收入為790萬美元，截至2023年6月30日的三個月的總收入為600萬美元，較2023年第二季成長32%。

As a reminder, our revenue is made up of three components, biologics and drug delivery, neurosurgery navigation and therapy, and capital equipment and software. Biologics and drug delivery revenue include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products. Biologics and drug delivery revenue increased 28% to $4.3 million in the second quarter, up from $3.4 million in 2023.

提醒一下，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。生物製品和藥物輸送收入包括與客戶贊助的使用我們產品的臨床前和臨床試驗相關的一次性產品和服務的銷售。第二季生物製劑和藥物輸送收入成長 28%，達到 430 萬美元，高於 2023 年的 340 萬美元。

This increase was fueled by $1.3 million or 383% increase in biologics and drug delivery product revenue as multiple pharmaceutical customers progressed in their preclinical and clinical development. The biologics and drug delivery growth was partially offset by $0.4 million decrease in service revenue.

隨著多個製藥客戶在臨床前和臨床開發方面取得進展，生物製劑和藥物輸送產品收入增加了 130 萬美元，即 383%，推動了這一成長。生物製品和藥物輸送的成長被服務收入減少 40 萬美元部分抵消。

Neurosurgery navigation revenue consists of commercial sales of disposable products related to cases utilizing the Clearpoint system, the PRISM laser system or SmartFrame OR. This revenue segment increased 17% to $2.6 million for the second quarter of 2024. The revenue growth is primarily attributable to our new product offerings and our new recent placements.

神經外科導航收入包括與使用 Clearpoint 系統、PRISM 雷射系統或 SmartFrame OR 的病例相關的一次性產品的商業銷售。2024 年第二季度，該部門的營收成長了 17%，達到 260 萬美元。收入成長主要歸功於我們的新產品供應和我們最近的新佈局。

Capital equipment and software revenue consisting of sales of Clearpoint reusable hardware and software and of related services increased 148% to $0.9 million in the quarter from $0.4 million for the same period in 2023 due to an increase in the placement of Clearpoint Navigation capital and software and PRISM laser units.

由於 Clearpoint Navigation 資本和軟體的投放增加以及PRISM 雷射單元。

Gross margin for the second quarter of 2024 was 63% as compared to a gross margin of 53% for the second quarter of 2023. The increase in gross margin was primarily due to lower cost for the three months ended June 30, 2024, due to the transition to the new manufacturing facility occurring in 2023 and higher volumes in 2024.

2024 年第二季的毛利率為 63%，而 2023 年第二季的毛利率為 53%。毛利率的成長主要是由於截至 2024 年 6 月 30 日的三個月的成本降低，這是由於 2023 年過渡到新製造工廠以及 2024 年產量增加所致。

In the second quarter of 2024, our operating expenses were $9.7 million compared to $10.3 million for the second quarter of 2023 as we continue to gain operating leverage. Research and development costs were $3.1 million for the three months ended June 30, 2024, compared to $3.6 million for the same period in 2023, a decrease of $0.5 million or 13%.

隨著我們繼續獲得營運槓桿，2024 年第二季我們的營運費用為 970 萬美元，而 2023 年第二季為 1,030 萬美元。截至 2024 年 6 月 30 日止三個月，研發成本為 310 萬美元，而 2023 年同期為 360 萬美元，減少 50 萬美元，即 13%。

The decrease was due primarily to lower product and software development costs of $1 million as a result of reprioritization of certain research and development initiatives, partially offset by increased personnel costs of $0.3 million and trial cost of $0.2 million.

減少的主要原因是某些研發計劃的優先順序調整導致產品和軟體開發成本降低了 100 萬美元，但部分被增加的 30 萬美元的人員​​成本和 20 萬美元的試驗成本所抵消。

Sales and marketing expenses were $3.8 million for the second quarter compared to $3.5 million for the same period in 2023, an increase of $0.4 million or 10%. This increase was due to additional personnel costs and travel expenses as we expand our commercial reach as we execute on our new product launches and prepare for increased procedural volume.

第二季銷售和行銷費用為 380 萬美元，而 2023 年同期為 350 萬美元，增加了 40 萬美元，增幅為 10%。這一增長是由於我們在執行新產品發布並準備增加程序量時擴大了商業範圍，因此增加了人員成本和差旅費用。

General and administrative expenses were $2.8 million for the second quarter compared to $3.2 million for the same period in 2023, a decrease of $0.4 million or 13%. This decrease was due primarily to lower bad debt expense of $0.7 million, mainly as a result of subsequent recoveries, partially offset by higher personnel costs and share-based compensation of $0.2 million. As of June 30, 2024, our year-to-date operating expenses were about 4% lower than our operating expenses in the same period of the prior year despite growing our revenue 36% in the first half of 2024.

第二季一般及管理費用為 280 萬美元，而 2023 年同期為 320 萬美元，減少了 40 萬美元，即 13%。這一減少主要是由於壞帳費用減少了 70 萬美元，主要是由於隨後的收回，部分被較高的人員成本和 20 萬美元的股權激勵所抵消。截至 2024 年 6 月 30 日，儘管 2024 年上半年我們的收入成長了 36%，但我們年初至今的營運費用比去年同期的營運費用低約 4%。

With respect to our cash position, as of June 30, 2024, we held cash and cash equivalents of $32.8 million compared to $23.1 million as of December 31, 2023. In line with the prior quarters, we continue to meaningfully reduce our operational cash burn.

就我們的現金狀況而言，截至 2024 年 6 月 30 日，我們持有現金和現金等價物為 3,280 萬美元，而截至 2023 年 12 月 31 日，我們持有現金和現金等價物為 2,310 萬美元。與前幾季一樣，我們繼續大幅減少營運現金消耗。

Our operational cash burn in the second quarter of 2024 was $2.7 million or 47% lower than our operational cash burn in Q2 2023. In the past trailing 12 months, our operational cash burn was $9.5 million. This represents a 46% reduction compared to the corresponding prior 12-month period, that is, from July 2022 to June 2023.

我們 2024 年第二季的營運現金消耗為 270 萬美元，比 2023 年第二季的營運現金消耗低 47%。在過去 12 個月中，我們的營運現金消耗為 950 萬美元。與之前 12 個月期間（即 2022 年 7 月至 2023 年 6 月）相比，減少了 46%。

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

有了這個，我現在想把電話轉回給喬。

Thanks, Danilo. As mentioned previously, 2024 is off to a great start with a 36% 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 and balance sheet. As always, let's now break down that progress into our four growth pillars. Starting with pillar number one, biologics and drug delivery. We had a terrific quarter on numerous fronts.

謝謝，達尼洛。如前所述，2024 年有一個良好的開端，收入增長36%，營運現金消耗減少39%，推出多種新產品，增加長期製藥合作夥伴關係，我們的產品組合在全球範圍內擴張，並且現金狀況強勁和資產負債表。像往常一樣，現在讓我們將這一進展分解為我們的四個成長支柱。從第一支柱開始，生物製品和藥物輸送。我們在很多方面都度過了一個出色的季度。

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 product sales to pharma partners, representing $1.3 million of growth for the quarter. This is very important as it shows the progression of our partners who are advancing along the regulatory pathway and moving beyond the benchtop where product sales are limited and into large multi-subject GLP preclinical trials and first-in-human clinical trial.

讓我們來談談我們的基因和細胞治療業務最近的四個關鍵里程碑。首先，正如 Danilo 所提到的，我們看到製藥合作夥伴的產品銷售額顯著增加，本季成長了 130 萬美元。這非常重要，因為它顯示了我們的合作夥伴的進步，他們正在沿著監管途徑前進，超越產品銷售有限的實驗室，進入大型多受試者 GLP 臨床前試驗和首次人體臨床試驗。

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. We now have seven partnered programs that have been designated as 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 these drugs may have to patients.

其次，我們現在看到多個合作夥伴被選擇用於各種加速 FDA 途徑，旨在加速這些新的細胞和基因療法（通常稱為再生療法）的臨床試驗執行和最終監管批准。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，以及對這些藥物可能改變生活的影響的認識。

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

雖然永遠無法保證時間表或批准，但FDA 已經創建了這些加速途徑，並且我們的許多合作夥伴已經證明了足夠顯著的進展和臨床結果，有資格參與這些計劃，這非常令人放心和令人興奮。總的來說，如果我們將這些加急計畫中現在包含的所有適應症加在一起，就可以計算出全球數百萬名患者的總盛行率。

Third, we continue to make progress expanding our preclinical services and capacity with the next strategic goal to be GLP ready this year and to commence with our initial GLP studies in 2025. Our team continues to feel confident in the demand for our products and services as well as our team's unique expertise.

第三，我們繼續在擴大臨床前服務和能力方面取得進展，下一個策略目標是今年做好 GLP 準備，並於 2025 年開始初步 GLP 研究。我們的團隊繼續對我們的產品和服務的需求以及我們團隊獨特的專業知識充滿信心。

We believe in our ability to execute larger studies under GLP compliant procedures and in GLP facilities. This further evolution of our drug delivery business will continue to expand not just the value that we provide, but also help us build even stronger long-term relationships with the pharmaceutical industry.

我們相信我們有能力根據 GLP 合規程序和 GLP 設施執行更大規模的研究。我們藥物輸送業務的進一步發展不僅將繼續擴大我們提供的價值，還將幫助我們與製藥業建立更牢固的長期關係。

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.

第四，談到與製藥公司的關係，我們很高興與大家分享，我們現在已經在所有所需框架中執行了戰略協議，證明我們確實提供了細胞和基因治療界所重視的獨特能力。

These frameworks also demonstrate our creativity and flexibility on how we can partner based on the needs of each individual pharma partner. We obviously cannot provide detailed pricing or confidential strategic information, but what I can share is that we now have successful signed agreements, representing four different parameters and sometimes a combination of those.

這些框架也展示了我們在如何根據每個製藥合作夥伴的需求進行合作方面的創造力和靈活性。我們顯然無法提供詳細的定價或機密戰略信息，但我可以分享的是，我們現在已經成功簽署了協議，代表四個不同的參數，有時是這些參數的組合。

For example, number one, co-development where a partner pays a development fee and development milestones to Clearpoint for custom development of a delivery device or software that will be used in their preclinical and clinical trials.

例如，第一，合作開發，合作夥伴向 Clearpoint 支付開發費用和開發里程碑，以客製化開發將在其臨床前和臨床試驗中使用的輸送設備或軟體。

Number two, commercial pricing, where a partner intends to provide their drug in a kit with the Clearpoint Neuro technology to simplify the commercial delivery of the product and purchase the devices directly from Clearpoint instead of Clearpoint having to sell the product to hospitals. The commercial pricing is at a premium when compared to the bench and preclinical trial patients.

第二，商業定價，合作夥伴打算在採用 Clearpoint Neuro 技術的試劑盒中提供藥物，以簡化產品的商業交付，並直接從 Clearpoint 購買設備，而不是 Clearpoint 必須將產品出售給醫院。與實驗室和臨床前試驗患者相比，商業定價較高。

Number three, clinical milestones, whereby Clearpoint Neuro gets a cash payment upon progression of a drug through the regulatory pathway. For example, approval of an IDE or IND study protocol being granted by the FDA or the first patient enrolled in a clinical 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 commercial approval.

第三，臨床里程碑，Clearpoint Neuro 在藥物透過監管途徑取得進展時獲得現金付款。例如，FDA 批准 IDE 或 IND 研究方案或參加臨床試驗的第一位患者。重要的是，這些里程碑可以在藥物發現和監管過程中發生，而不必在最終獲得商業批准時發生。

And finally, number four, a royalty payment to Clearpoint Neuro based on the drug itself and the commercial sales of that cell or gene therapy, which is delivered using the Clearpoint delivery devices. As a reminder, while not assured, we believe it is likely that these new-to-world drugs will be approved as combination devices with the Clearpoint Neuro cannulas and catheters as was seen in the European Union for the very first neurogene therapy already approved.

最後，第四點，根據藥物本身以及使用 Clearpoint 輸送設備輸送的細胞或基因療法的商業銷售情況向 Clearpoint Neuro 支付特許權使用費。提醒一下，雖然不確定，但我們相信這些新藥物很可能會被批准作為與 Clearpoint Neuro 插管和導管的組合裝置，就像歐盟已經批准的第一個神經基因療法一樣。

Our company, therefore, becomes an essential supplier to our pharma partners. 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 more. It is this long-term need and partnership that puts us in a position to earn more than just an arm's length transaction for our products.

因此，我們公司成為我們製藥合作夥伴的重要供應商。因此，我們的合作夥伴正在尋求非常長期的協議、供應保證、獲得 Clearpoint Neuro 獨特的智慧財產權、製造冗餘等。正是這種長期需求和合作關係使我們能夠賺取的不僅僅是我們產品的公平交易。

Moving on to pillar number two, which is neurosurgery navigation, we saw 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 full market release of our SmartFrame OR system designed for use with CT scans. (technical difficulty) Sorry, I think we're having a couple of technical issues. Can you hear me now?

轉向第二個支柱，即神經外科導航，我們看到本季度客戶網站啟動和產品銷售加速，這得益於我們傳統 MRI 引導導航系統的部署以及我們設計的 SmartFrame OR 系統的全面市場發布。 CT 掃描。（技術困難） 抱歉，我認為我們遇到了一些技術問題。現在你能聽到我說話嗎？

Your audio is back, sir.

先生，您的音訊回來了。

All right, everybody, sorry about the technical issues here. I'm going to go ahead and pick up the script where I left off.

好吧，大家，很抱歉這裡出現了技術問題。我要繼續從上次中斷的地方繼續寫劇本。

So as a reminder, in Q1 of this year, we activated eight new customers, which was by far a new record. In fact, in prior years, opening eight new sites would take a full 12 months, and we accomplished that in the first quarter alone. In Q2, we followed on that success with an additional six customer activations, bringing our total to 14 so far this year. These accelerated placements have helped fuel not only our disposable product sales, which we will talk about in a second, but also capital rental and service sales, which more than doubled versus a year ago.

提醒一下，今年第一季，我們啟動了八個新客戶，這是迄今為止的新紀錄。事實上，往年開設8個新站點需要整整12個月的時間，而我們僅在第一季就完成了這項任務。在第二季度，我們繼這一成功之後又啟動了 6 位客戶，使今年迄今的客戶總數達到 14 位。這些加速安置不僅有助於推動我們的一次性產品銷售（我們將在稍後討論），而且還有助於推動資本租賃和服務銷售，與一年前相比增加了一倍多。

We believe that we have a strong funnel of additional qualified global targets, giving us plenty of shots on goal to achieve 100 global sites by the end of 2025, if not sooner. The SmartFrame OR platform continues to gain traction with additional cases and experience.

我們相信，我們擁有一個強大的額外合格全球目標管道，使我們有足夠的機會實現 2025 年底（甚至更早）實現 100 個全球站點的目標。SmartFrame OR 平台隨著更多案例和經驗不斷獲得關注。

The early feedback we got from our limited market release gave us enough confidence to move quickly into full market release in concert with the ASSFN meeting in Nashville in June. We currently have the SmartFrame OR going through multiple VAC or VAC committee reviews around the country and expect additional growth here in the second half.

我們從有限的市場發布中獲得的早期反饋給了我們足夠的信心，以配合 6 月在納許維爾舉行的 ASSFN 會議，迅速進入全面的市場發布。目前，我們的 SmartFrame OR 正在全國各地接受多個 VAC 或 VAC 委員會的審查，預計下半年將有進一步成長。

I invite you to join our webinar led by Dr. Conner at the University of Oklahoma later this quarter, where he will share his early experiences with the SmartFrame OR product and how it has changed his practice at the university.

我邀請您參加本季稍後在俄克拉荷馬大學由 Conner 博士主持的網路研討會，他將在會上分享他使用 SmartFrame OR 產品的早期經驗以及該產品如何改變了他在大學的實踐。

Next, let's move on to pillar number three, which is therapy and access products. In the 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 robotics systems at sites that simply prefer to use the robotics navigation in place of our Clearpoint navigation.

接下來，讓我們繼續討論第三支柱，即治療和獲取產品。本季度，我們獲得了 FDA 對 PRISM 錨栓配件的許可，這為在那些更喜歡使用機器人導航代替 Clearpoint 導航的地點使用我們的 PRISM 雷射系統和一些現有機器人系統打開了大門。

We have performed first cases using the standardized workflow, which enabled us to move into full market release for the PRISM system. While we do not expect some of these bolt customers to eventually -- while we do expect some of these bolt customers to eventually move to a full Clearpoint navigated workflow for laser, it's an important first step to offer a solution that fits into their existing workflow so that we are not asking for too much change to their procedure flow on day one.

我們已經使用標準化工作流程執行了第一個案例，這使我們能夠進入 PRISM 系統的全面市場發布。雖然我們不期望其中一些螺栓客戶最終會遷移到完整的 Clearpoint 導航雷射工作流程，但提供適合其現有工作流程的解決方案是重要的第一步這樣我們就不會在第一天就要求對他們的程序流程進行太多改變。

Similar to the SmartFrame OR, we have a number of evaluations and VAC committee approvals underway. And we expect to see accelerated growth of these disposable laser fibers here in the second half. We do remain somewhat limited to about half of the laser market today as our system is currently only approved for three Tesla scanners.

與 SmartFrame OR 類似，我們正在進行多項評估和 VAC 委員會批准。我們預計下半年這些一次性雷射光纖將加速成長。由於我們的系統目前僅獲準用於三台 Tesla 掃描儀，因此我們在某種程度上仍局限於當今雷射市場的一半左右。

However, there are plenty of target hospitals to keep us busy while we develop the regulatory pathway for the other half of the market, responsible today by 1.5 Tesla scanners, which that approval we anticipate in 2025.

然而，在我們為另一半市場開發監管途徑（目前由 1.5 Tesla 掃描儀負責）的同時，還有很多目標醫院讓我們忙碌，我們預計該批准將在 2025 年獲得。

We have also made significant progress on our MRI conditional power drill, which we believe will be a powerful complement to our therapy and access product portfolio. This tool in partnership with adeor medical is designed to provide significantly faster access for surgeons than our current hand drill and has the potential to meaningfully reduce procedure time. Our current plan is to submit this product before the end of the year with a commercial introduction sometime in 2025.

我們在 MRI 條件電鑽方面也取得了重大進展，我們相信這將是對我們的治療和接觸產品組合的有力補充。該工具與 adeor Medical 合作，旨在為外科醫生提供比我們目前的手鑽更快的操作速度，並有可能大幅減少手術時間。我們目前的計劃是在今年年底之前提交該產品，並在 2025 年某個時候進行商業推廣。

Now when we report numbers for neurosurgery navigation and therapy, we bucket them together into medical device disposables. As Danilo mentioned, this segment grew 17% in the quarter. It is important to note that this growth was despite $400,000 in services from our brain computer interface partners, which was not repeated here in 2024. Without the brain computer interface service revenue from 2023 and only comparing product sales, the neurosurgery navigation and therapy segment actually grew 42% year-over-year and even grew 34% compared to last quarter alone.

現在，當我們報告神經外科導航和治療的數據時，我們將它們一起放入一次性醫療設備中。正如 Danilo 所提到的，該細分市場在本季度增長了 17%。值得注意的是，儘管我們的腦機介面合作夥伴提供了 40 萬美元的服務，但這種成長是在 2024 年沒有重複的。如果不考慮2023年起的腦機介面服務收入，僅比較產品銷量，神經外科導航和治療細分市場實際上同比增長了42%，僅與上季度相比就增長了34%。

Overall, our product sales more than doubled versus a year ago, which has a positive impact on gross margin due to the increased throughput at our factory. Speaking of which, let's talk about pillar number four, which is in achieving global scale. This was another disciplined quarter from a spending standpoint that saw a 32% revenue growth while keeping operating expenses generally flat.

總體而言，我們的產品銷售量比一年前增加了一倍多，由於我們工廠吞吐量的增加，這對毛利率產生了積極影響。說到這裡，我們來談談第四個支柱，也就是實現全球規模。從支出角度來看，這是另一個嚴格的季度，收入成長了 32%，同時營運支出基本上持平。

Our gross margin also expanded to 63%, which resulted in an operating cash burn reduction of 47% in the quarter, demonstrating our continued progress towards cash flow breakeven. We continue to believe that a cash flow breakeven quarter by the end of 2025 is possible and feel like we are in a strong cash position today with over $32 million in cash and cash equivalents.

我們的毛利率也擴大至 63%，導致本季營運現金消耗減少 47%，這表明我們在實現現金流盈虧平衡方面不斷取得進展。我們仍然相信，到 2025 年底，季度現金流可能實現盈虧平衡，並且我們目前的現金狀況良好，擁有超過 3,200 萬美元的現金和現金等價物。

Based on the strong first half performance of the team, we feel comfortable increasing our revenue guidance for the year to a new range of between $30 million and $33 million in total revenue, representing growth of between 25% and 38% for the year.

基於團隊上半年的強勁表現，我們放心地將今年的收入指引提高到總收入 3,000 萬美元至 3,300 萬美元之間的新範圍，即全年增長 25% 至 38% 之間。

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

至此，我們現在將開放電話詢問任何問題。

(Operator Instructions)

（操作員說明）

Frank Takkinen, Lake Street Capital.

塔基寧（Frank Takkinen），湖街資本公司。

Great. Thanks for taking the questions and congrats on really the great progress really across the entire board. Congrats on the increased guidance. Maybe I wanted to start there. Just curious what's contemplated versus the low end of the guidance versus the high end of the guidance, obviously, impressive growth profile regardless of where that comes into, but just was curious what you're thinking about needs to occur for the top end versus low end?

偉大的。感謝您提出問題，並祝賀整個董事會的巨大進步。恭喜您增加了指導。也許我想從那裡開始。只是好奇相對於指導的低端與高端的預期，顯然，無論進入何處，增長概況都令人印象深刻，但只是好奇您所考慮的高端與低端需要發生什麼結尾？

Yeah. Happy to answer, and thanks for the question, Frank. Yes, by going from $30 million to $33 million, we still leave a large enough window that I think sort of appropriately reflects some of the uncertainty that can happen from quarter-to-quarter. So as an example, like we've talked about in the past, we are -- I don't say routinely, but we have in our forecast a number of sort of preclinical services for our pharma partners, where any one of those services or trial support mechanisms could top a $1 million, maybe even $1.5 million today.

是的。很高興回答，謝謝你的問題，弗蘭克。是的，從 3000 萬美元增加到 3300 萬美元，我們仍然留下了一個足夠大的窗口，我認為這在某種程度上適當地反映了每個季度可能發生的一些不確定性。舉個例子，就像我們過去談到的那樣，我們 - 我不會說是例行公事，但我們預測為我們的製藥合作夥伴提供多種臨床前服務，其中任何一項服務或者試驗支持機制可能會超過100 萬美元，今天甚至可能達到150 萬美元。

And based on the timing of our partner, if that were to happen in December versus January of next year, you can see a $1 million to $1.5 million swing. So that's really the difference. Our view is that we feel like we've got a strong forecast to the -- certainly to the middle of the guidance that we've just adjusted. And the top and bottom range really reflect the timing more on the pharmaceutical side, if anything.

根據我們合作夥伴的時間安排，如果這種情況發生在 12 月與明年 1 月，您可以看到 100 萬美元到 150 萬美元的波動。這就是真正的區別。我們的觀點是，我們感覺到我們對剛剛調整的指引的中間位置有一個強有力的預測。如果有的話，頂部和底部範圍確實更多地反映了製藥方面的時機。

Got it. That's helpful. And then maybe for my second one, just wanted to ask about the new sites activated. Obviously, Q1 strong at 8%, Q2 strong again at 6%. Maybe talk about that onboarding process, how that has gone with this many new sites being activated in a short period of time, how quickly they can scale up, start ordering product? And then maybe as a last part to that question, any color related to how many of those sites adopted for both classic Clearpoint as well as the laser system?

知道了。這很有幫助。然後也許對於我的第二個，只是想詢問激活的新網站。顯然，第一季強勁成長 8%，第二季再次強勁成長 6%。也許可以談談入職流程，在短時間內啟動這麼多新網站的情況如何，他們能夠以多快的速度擴大規模，開始訂購產品？然後，也許作為該問題的最後一部分，與經典 Clearpoint 和雷射系統採用的這些站點中有多少相關的任何顏色？

Yeah, sure. So as we think about those sites, the majority of the placements of those 14 we've seen this year have still been the traditional MRI navigation type. So these were pent-up demand in certain circumstances, some were driven by interest in our laser platform that drove them to bring our navigation system along as well.

是的，當然。因此，當我們考慮這些網站時，我們今年看到的這 14 個網站中的大部分佈局仍然是傳統的 MRI 導航類型。因此，在某些情況下，這些需求是被壓抑的，有些需求是由對我們的雷射平台的興趣所驅動的，這促使他們也帶上我們的導航系統。

In some cases, it's hospitals that are preparing to participate in certain clinical trials down the road in the gene and cell therapy space and are getting the system installed and their staff up and running and familiar with the technology.

在某些情況下，醫院正準備參與基因和細胞治療領域的某些臨床試驗，並安裝系統，讓他們的員工啟動和運作並熟悉該技術。

So really what that mechanism looks like, a hospital never wants to do their very first clinical trial patients and have that also be their very first Clearpoint patient. So what happens more commonly is the hospital is very interested in cell and gene therapy.

所以實際上這個機制是什麼樣子的，醫院從來不想當他們的第一個臨床試驗患者，也不想讓這也成為他們的第一個 Clearpoint 患者。所以更常見的情況是醫院對細胞和基因治療非常感興趣。

They see our Clearpoint system as a necessary component to participate and they start their practice by doing simpler biopsy procedures, laser procedures, DBS procedures to become familiar with the technology before they start enrolling these incredibly expensive and important cell and gene therapy trial patients. So that's really where most of the demand has been. The caveat to that, which is, I think, is an important one, Frank, is that we're really not seeing much of the impact just yet from SmartFrame OR.

他們將我們的Clearpoint 系統視為參與的必要組成部分，並透過進行更簡單的活檢程序、雷射程序、DBS 程序來開始實踐，以熟悉該技術，然後再開始招募這些極其昂貴且重要的細胞和基因治療試驗患者。所以這確實是大部分需求所在。弗蘭克，我認為這一點很重要，但需要注意的是，我們實際上還沒有看到 SmartFrame OR 帶來的太大影響。

So as I mentioned in the prepared remarks, we actively have our system and our economic justification in front of the value committees at various hospitals. But even getting just a disposable system sometimes takes a little bit of time. You have to justify each and every spend the hospital makes these days.

正如我在準備好的演講中所提到的，我們積極向各醫院的價值委員會展示我們的系統和經濟合理性。但即使只是獲得一個一次性系統有時也需要一點時間。你必須證明醫院這些天的每一筆支出都是合理的。

So we're currently going through the process. But what I would say is we haven't found -- we don't have an instance where a VAC committee has rejected us yet. It's really a situation where the meeting might only take place once a month or once every two months, and that's the slowing factor.

所以我們目前正在經歷這個過程。但我想說的是，我們還沒有發現 VAC 委員會拒絕我們的例子。實際上，會議可能每月一次或每兩個月一次，這就是放緩因素。

But once we have -- what I say is, once we have approval from a VAC committee either for an MRI-guided system or for the operating room system, we've got ample supply, we've hired additional clinical specialists that are in training right now to prepare for this demand. And if you look at our inventory levels, they're still somewhat elevated because we do have products ready to be installed on the capital side. So we can move pretty quickly once we get the green light from the hospital.

但一旦我們——我想說的是，一旦我們獲得 VAC 委員會對 MRI 導引系統或手術室系統的批准，我們就有了充足的供應，我們已經聘請了更多的臨床專家現在就進行培訓，為這項需求做好準備。如果你看看我們的庫存水平，它們仍然有所上升，因為我們確實有準備在資本方面安裝的產品。因此，一旦獲得醫院的批准，我們很快就可以採取行動。

Got it. That's helpful. Thanks, and congrats again.

知道了。這很有幫助。謝謝，並再次恭喜。

Thanks Frank.

謝謝弗蘭克。

Kyle Bauser, B. Riley.

凱爾·鮑瑟，B.萊利。

Great. Thanks for taking my questions, and I'll echo Frank's comments, a really strong and clean quarter all around, so congrats. As you march towards cash flow positive territory, the biologics business will, of course, be a key contributor. And now as you -- as a project matures in this business, you generate more revenues. But can you talk about economies of scale across these projects that -- I know you're focused on a lot of different indications, but presumably, you aren't having to start from scratch on every new project. So just kind of curious if you could talk a little bit more about how this business will be a key driver of margin expansion?

偉大的。感謝您提出我的問題，我將回應弗蘭克的評論，這是一個非常強勁和乾淨的季度，所以恭喜。當您邁向現金流量正值領域時，生物製品業務當然將成為關鍵貢獻者。現在，隨著這個行業的專案成熟，您會產生更多的收入。但你能談談這些項目的規模經濟嗎？ 我知道你關注很多不同的跡象，但想必你不必從頭開始每個新項目。所以我有點好奇您是否可以多談談這項業務將如何成為利潤擴張的關鍵驅動力？

Yeah, happy to. I'll give you a few examples here and there as well. But the biggest benefit that we get, that's clearly number one is the fact that the same Clearpoint platform and navigation system supports all of these different procedure types that we talked about, whether it's biopsy or deep brain stimulation or laser ablation or drug delivery, you're still talking about navigating with our same system and our same software and the disposable elements, the capital elements, even the software workflow is probably 90% to 95% identical across each one of those different things.

是的，很高興。我也會在這裡和那裡給你一些例子。但我們獲得的最大好處，顯然是第一位的，是相同的 Clearpoint 平台和導航系統支持我們談到的所有這些不同的手術類型，無論是活檢、深部腦刺激、激光消融還是藥物輸送，您仍在談論使用我們相同的系統和相同的軟體進行導航，以及一次性元素、資本元素，甚至軟體工作流程在這些不同的事物中的每一個都可能有90% 到95% 的相同。

So as we talked about with Frank's question, bringing a new site up and running is easy to do because they can practice on simpler procedures like biopsies to prepare them for more complex gene therapy ones. So we get economies of scale on the fact that it's the same capital equipment and the same navigation headframe that goes in, as well as the training and education of the site. So I think that's absolutely an important component.

因此，正如我們討論弗蘭克的問題時，建立並運行一個新地點很容易，因為他們可以練習活檢等更簡單的程序，為更複雜的基因治療做好準備。因此，我們獲得了規模經濟，因為它使用相同的資本設備和相同的導航主機架，以及現場的培訓和教育。所以我認為這絕對是一個重要的組成部分。

The second one is that as we get into these larger preclinical and clinical trials, a hospital is not buying or a pharma company is not buying five or 10 prototype cannulas at this point, but rather they're purchasing maybe 100, 200 cannulas in navigation system, sometimes all at once, which we can then produce in a batch manner as opposed to doing these small little shipments through sterilization and everything else.

第二個是，當我們進入這些更大規模的臨床前和臨床試驗時，醫院不會購買或製藥公司此時不會購買5 或10 個原型插管，而是他們可能會購買100、200 個導航插管系統，有時是一次性的，然後我們可以大量生產，而不是透過滅菌和其他一切來進行這些小批量的運輸。

So as we get into these larger studies, we absolutely get margin expansion there because we are producing many more products at the same time as part of the same batch. So there's more examples than that, but those are the two that certainly pop front of mind.

因此，當我們進行這些更大規模的研究時，我們絕對會獲得利潤擴張，因為我們作為同一批次的一部分同時生產更多的產品。所以還有更多的例子，但這兩個肯定是最先浮現在腦海中的。

Got it. I appreciate that. And maybe sticking with the biologics business. So you talked about adding new preclinical and clinical trial services in your prepared remarks, you talked about GLP-ready studies, which is great, a big new area. Can you provide a little bit more color here and talk about examples of other services that you could add? And are these mostly based on feedback you're receiving from your existing customers or just kind of obvious areas to move into?

知道了。我很欣賞這一點。也許還會繼續從事生物製劑業務。因此，您在準備好的演講中談到了添加新的臨床前和臨床試驗服務，您談到了 GLP 就緒研究，這很棒，是一個很大的新領域。您能否在此提供更多資訊並談談您可以添加的其他服務的範例？這些主要是基於您從現有客戶收到的回饋，還是只是一些明顯需要進入的領域？

Yeah. No, I think this has been a place where I think Clearpoint has been somewhat disciplined in our spending approach where we try not to make these large investments until we know that the demand is solid for them, sort of the field of dreams, if you build it, they were come, this is kind of the opposite of it. We're not building the fields until the team is ready to go.

是的。不，我認為 Clearpoint 在我們的支出方式上一直有一定的紀律性，在我們知道他們的需求是穩定的之前，我們盡量不進行這些大規模投資，這是一個夢想的領域，如果你建造它，他們就來了，這有點相反。在團隊準備好出發之前我們不會建造場地。

So I'd say we're very confident that any additional investment we're making right now into added capacity or added services or new quality control expertise to facilitate a GLP study, all those types of things, we wouldn't be making that investment now if we didn't see kind of a clear line of sight, not just for the value or the revenue we can generate as part of the GLP studies, but again, that intimate relationship we will have with the farmer partner to be working with them for the next 10, 15, 20 years throughout the entire drug discovery and commercialization process.

因此，我想說，我們非常有信心，我們現在為增加產能、增加服務或新的品質控制專業知識而進行的任何額外投資，以促進 GLP 研究，所有這些類型的事情，我們都不會這樣做如果我們沒有看到清晰的視線，現在就進行投資，不僅是為了我們作為GLP 研究的一部分可以產生的價值或收入，而且還是為了我們將與合作的農民合作夥伴建立的密切關係在未來10 年、15 年、20 年的整個藥物發現和商業化過程中都與他們一起。

So for concrete examples, it's nothing too much different than we already offer today. It's really the simple fact that having a GLP compliance facility is something that enables much larger studies that -- to your point or to your question before about gross margin, the same is true on these procedures as well, these GLP procedures because again, you're bashing them, you're doing many more subjects, sometimes 50, 60 subjects at a time, all over the course of six weeks as opposed to one or two subjects here and there. So I think we'll be able to see some gross margin expansion driven by this GLP presence as well.

因此，就具體示例而言，它與我們今天提供的沒有太大不同。這確實是一個簡單的事實，擁有 GLP 合規設施可以進行更大規模的研究，就您的觀點或您之前關於毛利率的問題而言，這些程序也是如此，這些 GLP 程序同樣如此，因為您在抨擊他們時，你會在六週的時間裡做更多的科目，有時一次做50、60 個科目，而不是時不時地做一兩個科目。因此，我認為我們也將能夠看到由 GLP 存在推動的毛利率擴張。

Okay. Got it. I appreciate that. Well, congrats again. I'll jump back in queue.

好的。知道了。我很欣賞這一點。嗯，再次恭喜。我會插回隊列。

Thanks Kyle.

謝謝凱爾。

(Operator Instructions)

（操作員說明）

Matt Blackman, Stifel.

馬特·布萊克曼，史蒂菲爾。

Hi. This is Emily on for Matt. Congrats on a great quarter, guys.

你好。這是艾米莉為馬特代言的。夥計們，恭喜你們度過了一個出色的季度。

Thanks, Emily.

謝謝，艾米麗。

Just a couple from me. In terms of kind of zooming out a bit for the health of biopharma companies, company reported this morning, so think some weakness there. I'm just wondering if you've seen any of that. Obviously, you're still signing contracts, but any projects being paused in your pipeline? Anything along those lines?

只是我的一對。該公司今天早上報告稱，就生物製藥公司的健康狀況而言，稍微縮小了一點，因此認為存在一些弱點。我只是想知道你是否見過這些。顯然，您仍在簽署合同，但您的管道中是否有任何項目暫停了？有什麼類似的事情嗎？

No. I mean if you look back to the start of this year, I'd say, it's been the opposite. Barring the craziness of Monday earlier this week, I think funding has actually been pretty healthy coming into this particular space. And the simple fact on our end at this point is if you think about the meetings we're having here at our headquarters in San Diego or meetings we're having up in San Francisco and in Europe and other places as well, we've got a very diversified base of partners, anything from small start-up biotech companies to some of the largest pharmaceutical companies in the world.

不。我的意思是，如果你回顧今年年初，我會說，情況恰恰相反。除了本週早些時候週一的瘋狂之外，我認為進入這個特定領域的資金實際上相當健康。目前我們這邊的一個簡單事實是，如果您考慮一下我們在聖地亞哥總部舉行的會議，或者我們在舊金山、歐洲和其他地方舉行的會議，我們已經擁有非常多元化的合作夥伴基礎，從小初創生物技術公司到世界上一些最大的製藥公司。

And obviously, the smaller companies have a little bit more risk there, but these large pharmaceutical companies are very, very cash fluid, let's call it. So we really have not seen any of those issues. Certainly not like we've seen over the last two or three years. This has been the healthiest it's been in quite some time.

顯然，規模較小的公司面臨的風險更大，但這些大型製藥公司的現金流動性非常非常大，我們可以這麼說。所以我們確實沒有看到任何這些問題。當然不像我們過去兩三年所看到的。這是相當長一段時間以來最健康的一次。

Okay. Great. And in terms of the biologics partners, you had a couple of kind of advance in their trials to Phase 1, Phase 2. At that point in a trial, aside from the product purchases, the batch purchases that you talked about, are you involved in other kind of service revenue, like regulatory prep, data collection? I know you've talked a little bit about that in the past.

好的。偉大的。就生物製劑合作夥伴而言，他們在第一階段、第二階段的試驗中取得了一些進展。在試驗的那個階段，除了您談到的產品採購、大量採購之外，您是否還涉及其他類型的服務收入，例如監管準備、資料收集？我知道你過去曾經談過這個問題。

So I'm just wondering kind of how you're involved as they are in that stage?

所以我只是想知道你是如何參與他們在那個階段的？

Yeah. Once they get to that stage, we are not acting today as clinical trial monitors, for example. So that's something I think if we wanted to build a team around that, we could probably use our sort of unique neuro focus and expertise to be successful there, but it's not an investment we're making today, and it's not something we've moved forward with yet. But I'd say, it will be a nice adjacent service that we could go into. The primary role that we played during those studies is the product, as you pointed out, as well as the clinical education and support of the site.

是的。例如，一旦他們到達那個階段，我們今天就不再扮演臨床試驗監督者的角色。所以我認為，如果我們想圍繞這個建立一個團隊，我們可能會利用我們獨特的神經焦點和專業知識在那裡取得成功，但這不是我們今天所做的投資，也不是我們已經做過的事情繼續前進。但我想說，這將是我們可以參與的一個很好的相鄰服務。正如您所指出的，我們在這些研究中發揮的主要作用是產品，以及該網站的臨床教育和支援。

There's two primary components of these procedures. There's the part that has to do with the drug, which the pharmacy has to transport the drug in, sort out in an appropriate period of time, mix it in certain cases and have it ready for distribution into the patient.

這些過程有兩個主要組成部分。還有與藥物有關的部分，藥房必須將藥物運輸進去，在適當的時間內進行分類，在某些情況下將其混合，並準備好分發給患者。

And then there's the surgical procedure itself, which includes the drilling, the pumps that puts the drug in, the cannulas that we make, which -- through which the drug is delivered, the navigation that get us to the target, the software that monitors the infusion and tells the surgeon, yes, everything is great, you can go ahead and close the patient, that's really the part of the ecosystem that we're trying to control. And we're getting more involved in training on pumps and everything required the day of the surgery.

然後是外科手術本身，包括鑽孔、注入藥物的幫浦、我們製造的插管（透過它們輸送藥物）、讓我們到達目標的導航、監控軟體輸液並告訴外科醫生，是的，一切都很好，你可以繼續關閉病人，這確實是我們試圖控制的生態系統的一部分。我們正在更多地參與泵和手術當天所需的一切培訓。

So if there's a clinical service that we provide is, again, it's not monitoring of the trial, but making sure everything the day of the surgery, even if it's a little bit beyond what the Clearpoint product does, some companies are hiring us to do additional services around pump infusions and things like that. Hopefully, that's helpful.

因此，如果我們提供的臨床服務不是監控試驗，而是確保手術當天的一切，即使它有點超出了 Clearpoint 產品的功能，一些公司正在僱用我們來做這件事圍繞泵輸液等的附加服務。希望有幫助。

Got it. Yeah, that's great. And then just one last one. In terms of the contract types that you're now kind of spreading your wings with royalties and such. Is there anything we should think about in terms of revenue cadence for those? I mean, is it going to remove some of the lumpiness with more of the long-term nature of some of those things? How should we be thinking about how the revenue is going to flow with your mix right now?

知道了。是的，那太好了。然後只有最後一張。就合約類型而言，您現在正在透過版稅等方式展開翅膀。就這些收入節奏而言，我們應該考慮什麼嗎？我的意思是，它會消除其中一些事情的長期性，從而消除一些混亂嗎？我們現在應該如何考慮收入將如何隨著您的組合流動？

Yeah. It's probably the opposite of removing the lumpiness. If anything, it's going to create more for a period of time. The good news is, like we said, we've got seven of these partners that are in these fast track expedited designations from the FDA. So certain milestones will come.

是的。這可能與消除結塊相反。如果有的話，它將在一段時間內創造更多。好消息是，正如我們所說，我們有七個合作夥伴已獲得 FDA 的快速指定。因此，某些里程碑將會到來。

We have some other large pharmaceutical companies that are deep into the GLP process, and will likely be starting their clinical trials here towards the end of 2024 and into 2025. So that's where you're going to start to see where one particular quarter, we could get a nice cash milestone which would also be 100% gross margin, for example, and the next quarter, not have one at all.

我們還有其他一些大型製藥公司正在深入 GLP 流程，很可能會在 2024 年底和 2025 年在這裡開始臨床試驗。因此，這就是你要開始看到的地方，在某個特定季度，我們可以獲得一個不錯的現金里程碑，例如，毛利率也是 100%，而下一個季度則根本沒有。

So if you don't like choppiness quarter-to-quarter, we might frustrate you a little bit. But again, if you look at the six month period, 12-month period, things like that, the trend of growth is certainly going to be there along with gross margins, too. So where I think it does start to even out whereas -- if we have multiple partners that are all in clinical trials and those are in that Phase 2, Phase 3 standpoint, maybe couple -- two, three years from now, that's where I think we're just going to have enough volume there that one individual milestone isn't kind of swing things positive or negative because these milestones or royalties or whatever they happen to be, are going to start to smooth things out.

因此，如果您不喜歡季度與季度之間的波動，我們可能會讓您感到有點沮喪。但同樣，如果你看 6 個月、12 個月等類似情況，成長趨勢肯定也會與毛利率一起出現。所以我認為它確實開始趨於平衡——如果我們有多個合作夥伴都在臨床試驗中，並且這些合作夥伴都處於第二階段、第三階段的立場，也許是一對——從現在起兩三年後，這就是我的情況我認為我們將有足夠的數量，一個單獨的里程碑不會對事情產生積極或消極的影響，因為這些里程碑或版稅或任何它們碰巧發生的事情，將開始使事情變得順利。

Got it. Great. Thank you.

知道了。偉大的。謝謝。

Sure. Thanks, Emily.

當然。謝謝，艾米麗。

At this time, there are no further questions in queue. I'd like to turn the call back over to Mr. Burnett for any further remarks.

目前，隊列中沒有其他問題。我想將電話轉回伯內特先生以徵求進一步意見。

Thanks again, Morgan. And once again, thank you to everyone interested in being a part of our 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 as well as additional first-in-human trials to initiate in the exciting cell and gene therapy market.

再次感謝，摩根。再次感謝所有有興趣參與我們團隊在 Clearpoint 之旅的人。這是一個令人興奮的時刻，因為我們計劃在所有四個成長支柱上推出新產品和服務，並在令人興奮的細胞和基因療法市場啟動額外的首次人體試驗。

We've worked very hard to get to this point and are very excited for our entire team, but we are even more excited for the patients that we hope to treat with these new devices and therapies in the near future. The patient and their family are why we are here, and they are ultimately who we are working for.

我們非常努力地達到了這一點，我們對整個團隊感到非常興奮，但我們對希望在不久的將來使用這些新設備和療法治療的患者感到更加興奮。患者及其家人是我們在這裡的原因，他們最終是我們為之工作的對象。

Thank you, and good night.

謝謝你，晚安。

This concludes the Clearpoint Neuro second quarter fiscal 2024 earnings call. Thank you for attending and have a great rest of your day.

Clearpoint Neuro 2024 財年第二季財報電話會議到此結束。感謝您的出席，祝您有個愉快的一天。