Clearpoint Neuro Inc (CLPT) 2023 Q3 法說會逐字稿

Thank you for standing by, and welcome to the ClearPoint Neuro, Inc. Q3 2023 earnings conference call. Comments made on this call may include statements that are forward-looking within the meaning of the securities laws.

感謝您的耐心等待，歡迎參加 ClearPoint Neuro, Inc. 2023 年第三季財報電話會議。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。

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 markets or the market opportunity for the company's products and services, and management's expectations, beliefs, estimates, or projections regarding future results of operations.

這些前瞻性陳述可能包括但不限於與預期產業趨勢、公司計畫、前景和策略（初步和預測）相關的陳述。公司產品和服務的總潛在市場或市場機會的規模，以及管理階層對未來營運績效的期望、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, 2022, and the company's quarterly report on Form 10-Q for the three months ended June 30, 2023, both of which have been filed with the Securities and Exchange Commission.

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2022年12月31日止年度的Form 10-K年度報告以及公司截至2023年6月30日止三個月的Form 10-Q季度報告。向美國證券交易委員會備案。

And the company's quarterly report on Form 10-Q for the three months ended September 30, 2023, which the company intends to file with the Securities and Exchange Commission on or before November 14, 2023. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com.

以及本公司截至2023年9月30日止三個月的10-Q表季度報告，本公司擬於2023年11月14日或之前向美國證券交易委員會提交該報告。公司的所有文件均可從美國證券交易委員會取得或公司網站 www.clearpointneuro.com。

I would now like to turn the call over to Joe Burnett, Chief Executive Officer, to begin the call. Joe, over to you.

我現在想將電話轉交給執行長喬·伯內特 (Joe Burnett)，他將開始通話。喬，交給你了。

Thank you, Mandeep, and thank you to all of the investors and analysts on today's call. ClearPoint Neuro is the premier cell, gene, and device therapy enabling company, uniquely focused on precise navigation, and quality control delivery to the brain.

謝謝曼迪普，也感謝參加今天電話會議的所有投資人和分析師。 ClearPoint Neuro 是領先的細胞、基因和設備治療支援公司，獨特地專注於精確導航和大腦品質控制。

Our four pillar growth strategy continued its progress here in the third quarter, with some important updates that I will discuss momentarily. The most important highlight, or point of emphasis we want to make on the call today, is our stated priority of flattening operational expenses, and improving cash flow.

我們的四大支柱成長策略在第三季繼續取得進展，我將立即討論一些重要的更新。我們今天在電話會議上要強調的最重要的亮點或重點是我們所聲明的壓平營運支出和改善現金流的優先事項。

Our operational cash burn in the third quarter was reduced to only $1.8 million, the lowest quarterly operational cash burn since 2020. The last few years, we have a raced to build a foundation, a team, and a product portfolio, that can prepare us to realize a total addressable market, that could treat more than 1 million newly diagnosed patients each year.

第三季我們的營運現金消耗減少至僅 180 萬美元，這是自 2020 年以來最低的季度營運現金消耗。過去幾年，我們競相建立基礎、團隊和產品組合，讓我們做好準備實現每年可治療超過100 萬新診斷患者的總目標市場。

And in doing so, create a $12 billion revenue opportunity for ClearPoint via our products services and partnerships. That unserved market is still very much our intention and our vision.

在此過程中，透過我們的產品服務和合作夥伴關係，為 ClearPoint 創造 120 億美元的收入機會。那個未被服務的市場仍然是我們的意圖和願景。

However, instead of continuing to invest in growing our capabilities and portfolio in the near term, we are going to make sure we focus on extracting value from the existing capabilities that we have already built and invested in, as well as new product launches that we already have planned here in 2024 and 2025.

然而，我們不會在短期內繼續投資於擴大我們的能力和產品組合，而是確保我們專注於從我們已經建立和投資的現有能力以及我們推出的新產品中獲取價值。已經計劃在2024年和2025年在這裡。

Our deepening partnerships with biologics and drug delivery companies, expansion of our navigation platform into the operating room, and the full market release of our Prism Laser Therapy System can sustain top line growth in the years ahead.

我們與生物製品和藥物輸送公司不斷深化的合作關係、將導航平台擴展到手術室以及棱鏡雷射治療系統的全面市場發布可以在未來幾年維持營收成長。

While the flattening of operational expenses scale in our newly certified Carlsbad manufacturing facility, and improvement to gross margins can create leverage, and ensure revenue grows faster than expenses for at least the next couple of years.

雖然我們新認證的卡爾斯巴德製造工廠營運費用規模的趨於平緩以及毛利率的提高可以創造槓桿作用，並確保至少在未來幾年內收入增長快於費用增長。

We continue to believe our goal of operational cash flow breakeven is achievable sometime in the second half of 2025. While this strategy does slightly reduce our forecasted revenue in 2023, to the range of $23 million to $25 million. We continue to expect operational cash flow to be meaningfully less in the second half of 2023 compared to the first half, with our Q3 result being the first tangible example of that commitment.

我們仍然相信，我們的營運現金流損益平衡目標可以在 2025 年下半年的某個時候實現。儘管這項策略確實略微降低了我們 2023 年的預測收入，至 2,300 萬美元至 2,500 萬美元之間。我們仍然預計 2023 年下半年的營運現金流將顯著低於上半年，我們的第三季業績是這項承諾的第一個具體例子。

Our strong balance sheet with over $24 million in cash and equivalents, will continue to enable us to launch these key new products, and execute on our strategic plan, while at the same time reduce our operational cash burn.

我們強大的資產負債表擁有超過 2,400 萬美元的現金和等價物，將繼續使我們能夠推出這些關鍵新產品，並執行我們的策略計劃，同時減少我們的營運現金消耗。

We are more excited for the company and its prospects than ever, as we expect that these launches in 2024 will introduce three new and additive revenue streams to our base, which I will talk about in more detail, a little bit later on the call.

我們對公司及其前景比以往任何時候都更加興奮，因為我們預計2024 年的這些發布將為我們的基礎帶來三種新的附加收入來源，我將在稍後的電話會議上更詳細地討論這一點。

I will now turn the call over to Danilo to discuss our Q3 financial results, after which I will provide additional color on our four pillar growth strategy. Danilo?

現在，我將把電話轉給達尼洛，討論我們第三季的財務業績，之後我將對我們的四大支柱成長策略提供更多資訊。達尼洛？

Thank you, Joe, and thank you all for joining us today. Looking at the third quarter 2023 results, total revenue was $5.8 million for the three months ended September 30, 2023, and $5.1 million for the three months ended September 30, 2022, which represents 12% growth versus the third quarter of 2022.

謝謝你，喬，也謝謝大家今天加入我們。看看2023年第三季的業績，截至2023年9月30日的三個月的總收入為580萬美元，截至2022年9月30日的三個月的總收入為510萬美元，較2022年第三季成長12%。

As a reminder, our revenue is made up of three components, biologics and drug delivery, functional neurosurgery navigation therapy, and capital equipment and software. Biologics and drug delivery revenue includes sales of disposable products and services, related to customer sponsored pre-clinical and clinical trials utilizing our products.

提醒一下，我們的收入由三個部分組成：生物製劑和藥物傳遞、功能性神經外科導航治療以及資本設備和軟體。生物製劑和藥物傳輸收入包括一次性產品和服務的銷售，與客戶贊助的使用我們產品的臨床前和臨床試驗相關。

Biologics and drug delivery revenue growth accelerated to 55% or $3.5 million in the third quarter up from $2.2 million in 2022. This increase was fueled by a 109% increase in biologics and drug delivery service revenue, as we expand our service offering to pharmaceutical customers. The biologics and drug delivery service growth was partially offset by $0.3 million decrease in product revenue.

第三季生物製劑和藥物輸送收入成長加速至55%，即350 萬美元，而2022 年為220 萬美元。隨著我們向製藥客戶提供的服務範圍不斷擴大，生物製劑和藥物輸送服務收入增長了109%，推動了這一成長。生物製品和給藥服務的成長被產品收入減少 30 萬美元部分抵消。

Functional neurosurgery navigation revenue consists of commercial sales of disposable products and services related to cases utilizing the ClearPoint system to deliver medical device therapy for the desired target. This revenue segment declined $0.5 million to $1.9 million for the third quarter.

功能性神經外科導航收入包括與利用 ClearPoint 系統為所需目標提供醫療設備治療的病例相關的一次性產品和服務的商業銷售。第三季該部門的收入下降了 50 萬美元，至 190 萬美元。

Capital equipment and software revenue consisting of sales of ClearPoint reusable hardware and software and related services decreased 26% to $0.4 million in the quarter from $0.5 million for the same period in 2022.

本季資本設備和軟體收入（包括 ClearPoint 可重複使用的硬體和軟體以及相關服務的銷售額）下降了 26%，從 2022 年同期的 50 萬美元降至 40 萬美元。

Gross margin for the third quarter of 2023 was 57% as compared to a gross margin of 71% for the third quarter 2022. The decrease in gross margin was primarily due to an increase in biologics and drug delivery preclinical services, which to date have had a lower margin than prior year, as we launch new services and increase our presence in the space. Increased costs related to the transition to the new manufacturing facility also contributed to the decrease in gross margin.

2023 年第三季的毛利率為57%，而2022 年第三季的毛利率為71%。毛利率下降主要是由於生物製劑和藥物輸送臨床前服務的增加，迄今為止，生物製劑和藥物輸送臨床前服務的增加隨著我們推出新服務並擴大在該領域的影響力，利潤率低於去年。與向新製造設施過渡相關的成本增加也導致毛利率下降。

Research and development costs were $2.4 million for the three months ended September 30, 2023, compared to $2.7 million for the same period in 2022, a decrease of 8%. The decrease was due primarily to reprioritization of certain research and development initiatives, partially offset by higher personnel and share-based compensation costs.

截至2023年9月30日止三個月的研發成本為240萬美元，較2022年同期的270萬美元下降8%。減少的主要原因是某些研發計劃的優先順序調整，但部分被人員和股權薪酬成本增加所抵消。

Sales and marketing expenses were $2.8 million for the third quarter compared to $2.4 million for the same period in 2022, an increase of $0.4 million or 17%. This increase was due to additional personnel costs, including share-based compensation, as we expand our commercial reach in preparation for multiple new product launches over the next 18 months.

第三季銷售和行銷費用為 280 萬美元，而 2022 年同期為 240 萬美元，增加了 40 萬美元，即 17%。這一增長是由於額外的人員成本（包括基於股權的薪酬）造成的，因為我們擴大了商業範圍，為未來 18 個月內推出多個新產品做準備。

This hiring reflects the learning curve required to train and educate on the expanding ClearPoint product portfolio, which will be targeting new physician customers, and new surgical arenas within hospitals.

此次招聘反映了對不斷擴大的 ClearPoint 產品組合進行培訓和教育所需的學習曲線，該產品組合將針對新的醫生客戶和醫院內的新手術領域。

General and administrative expenses were $2.9 million for the third quarter compared to $2.4 million for the same period in 2020 to an increase of $0.5 million or 21%. This increase was nearly all due to an increase in the allowance for credit losses of $0.5 million, partially offset by lower professional fees of $0.1 million.

第三季一般及管理費用為 290 萬美元，較 2020 年同期的 240 萬美元增加了 50 萬美元，增幅為 21%。這一增長幾乎全部是由於信用損失準備金增加了 50 萬美元，部分被專業費用降低 10 萬美元所抵消。

With respect to our cash position, as of September 30, 2023, we held cash and cash equivalents of $24.3 million compared to $26.5 million as of June 30, 2023. Our operational cash burn in Q3 was $1.8 million, down 54% from the prior year third quarter.

就我們的現金狀況而言，截至2023 年9 月30 日，我們持有現金和現金等價物為2,430 萬美元，而截至2023 年6 月30 日為2,650 萬美元。第三季的營運現金消耗為180萬美元，較上一季下降54%年第三季。

We maintained our focus on appropriate resource allocation and cash management, and remain committed to effectively and carefully managing our operating expenses. As anticipated in our prior earnings call, our operational cash burn in the third quarter was meaningfully below the operational cash burn of the prior quarters.

我們持續專注於適當的資源分配和現金管理，並持續致力於有效、謹慎地管理我們的營運費用。正如我們在先前的財報電話會議中所預期的那樣，我們第三季的營運現金消耗明顯低於前幾個季度的營運現金消耗。

In fact, it was the lowest of quarterly operational cash burn since 2020. The reduction in operational cash burn versus the first half of 2023, will continue enabled by one, the easing of supply chain conditions that allows us to gradually reduce inventory levels.

事實上，這是自 2020 年以來季度營運現金消耗最低的一次。與 2023 年上半年相比，營運現金消耗的減少將繼續得益於供應鏈條件的放鬆，使我們能夠逐步降低庫存水準。

Two, operating leverage due to higher revenue. Three, the completion of the transfer of some of the company's manufacturing operations to Carlsbad. And four, on the expense side, our existing headcount should be sufficient to support our business for the next 12 to 18 months. We will continue to take measures to reduce and contain cash burn going forward.

二是收入增加帶來的經營槓桿。三、完成公司部分製造業務向卡爾斯巴德的轉移。第四，在費用方面，我們現有的員工數量應該足以支持我們未來 12 到 18 個月的業務。我們將繼續採取措施減少和控制未來的現金消耗。

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. Our third quarter results represented a shift of priority to cash flow improvement, yielding a $1.8 million operational burn, while still demonstrating double digit growth overall, and an acceleration to 55% growth in biologics and drug delivery. These preclinical services are arguably our newest product launch, and are already delivering great early results.

謝謝，達尼洛。我們第三季的業績顯示我們將重點轉向改善現金流，產生了 180 萬美元的營運消耗，同時整體仍呈現兩位數成長，生物製劑和藥物輸送加速成長至 55%。這些臨床前服務可以說是我們推出的最新產品，並且已經取得了很好的早期成果。

Let's add a bit more detail to our four pillar growth strategy. First, looking at biologics and drug delivery, our strategy of building deeper, and more strategic partnerships, continues to make progress with additional sophisticated and long-term agreements signed in the quarter.

讓我們為我們的四大支柱成長策略添加更多細節。首先，在生物製劑和藥物傳遞方面，我們建立更深入、更具策略性的合作夥伴關係的策略繼續取得進展，本季度簽署了更多複雜的長期協議。

As a reminder, a couple of years ago, we were very much a product oriented biologics company, simply selling devices to pharma companies for use in clinical trials, as part of an arm's length transaction. Over the last two years, we have invested in tools and talent, to add clinical, development, regulatory, and other pre-clinical CRO services to our portfolio.

提醒一下，幾年前，我們在很大程度上是一家以產品為導向的生物製劑公司，只是將設備出售給製藥公司用於臨床試驗，作為公平交易的一部分。在過去兩年中，我們投資於工具和人才，將臨床、開發、監管和其他臨床前 CRO 服務添加到我們的產品組合中。

That investment or pivot is already yielding terrific results, with growth of 55% in that segment, and $3.5 million in total revenue for the quarter. To say in another way, this new capability in the last two years has already grown to be the largest part of our business today.

這項投資或轉型已經產生了驚人的成果，該領域成長了 55%，本季總收入達到 350 萬美元。換句話說，過去兩年的這種新能力已經發展成為我們今天業務的最大組成部分。

Our growth strategy is now less focused on accumulating partners, but rather building deeper strategic partnerships. These more sophisticated agreements may include longer duration, quarterly commitments, direct commercial pricing, clinical and regulatory milestones on the drug itself, and even royalties on commercial drug sales.

我們的成長策略現在不再專注於累積合作夥伴，而是建立更深層的策略夥伴關係。這些更複雜的協議可能包括更長的期限、季度承諾、直接商業定價、藥物本身的臨床和監管里程碑，甚至商業藥物銷售的特許權使用費。

Newly signed agreements are expected to be a combination of these different features, all of which are designed to demonstrate the long-term commitment and value that we offer. We continue to view ourselves as a device extension of our pharma partners, something that by working with us, there's no need for them to replicate internally.

新簽署的協議預計將結合這些不同的特點，所有這些都旨在展示我們提供的長期承諾和價值。我們繼續將自己視為製藥合作夥伴的設備延伸，透過與我們合作，他們無需在內部複製。

Our total number of active partners remains more than 50, despite the challenging capital markets that have forced some companies to delay or shutdown programs. Our diversification and biotech have served us well, as we continue to be viewed as a sort of lower risk biotech ETF, if you will, spread across multiple corporate partners, different patient indications, and even redundancy within the same indication with often multiple partners looking to treat the same disease.

儘管資本市場充滿挑戰，迫使一些公司推遲或關閉項目，但我們的活躍合作夥伴總數仍超過 50 個。我們的多元化和生物技術為我們提供了良好的服務，因為我們仍然被視為一種風險較低的生物技術ETF（如果您願意的話），分佈在多個公司合作夥伴、不同的患者適應症中，甚至在同一適應症中存在冗餘，通常有多個合作夥伴在尋找來治療同一種疾病。

While the mix of products and services in this segment can change dramatically quarter to quarter, based on the timing of certain preclinical and clinical trials, we do expect this to remain our fastest growing segment for at least the balance of 2023.

雖然該細分市場的產品和服務組合可能每季都會發生巨大變化，但根據某些臨床前和臨床試驗的時間安排，我們預計至少在2023 年餘下的時間裡，該細分市場仍將是我們成長最快的細分市場。

As we look to 2024, we will add a new revenue opportunity in our biologics business as we expect to achieve GLP readiness next year. We have also already built additional capacity for studies into our current expense run rate.

展望 2024 年，我們將在生物製劑業務中增加新的收入機會，因為我們預計明年將實現 GLP 準備。我們也已經建立了額外的能力來研究我們目前的費用運行率。

This means that in 2024, we will be able to accept pharma company request for GLP studies, that we've had to turn down in the past, and will have the added capacity to accommodate these studies without any significant increase to our expenses. This new capability and capacity will act as an additional source of revenue that will be new in 2024.

這意味著到2024 年，我們將能夠接受製藥公司進行GLP 研究的要求（我們過去曾不得不拒絕這項要求），並且將擁有額外的能力來適應這些研究，而不會顯著增加我們的費用。這種新的能力和產能將成為 2024 年新增的額外收入來源。

Moving on to pillar number two, functional neurosurgery navigation, we made significant strategic process, progress rather preparing for our next generation of products designed for use beyond the MRI and in the operating room itself.

轉向第二個支柱，功能性神經外科導航，我們取得了重大的戰略進程，取得了進展，而不是為下一代產品做準備，這些產品設計用於 MRI 之外和手術室本身。

From a financial standpoint, the segment showed a significant decline of more than 20%. However, the vast majority of that decline or almost $400,000 in the quarter, was the result of one development partner who was funding a brand computer interface project in 2022, and had to pause the program in 2023, due to financial constraints.

從財務角度來看，該細分市場出現了超過20%的大幅下滑。然而，本季下降的絕大部分（即近40 萬美元）是由一位開發合作夥伴造成的，該合作夥伴在2022 年為一個品牌電腦介面專案提供資金，但由於財務限制，不得不在2023 年暫停該項目。

From a capital standpoint, we see a shift away from outright capital purchases to more rental programs, which can sometimes fit in a hospital operating budget, without having to go through lengthy capital committee reviews.

從資本的角度來看，我們看到從直接資本購買轉向更多的租賃計劃，這有時可以適合醫院的營運預算，而無需經過冗長的資本委員會審查。

Now the economics of the total sale are similar. However, ClearPoint may be receiving, and therefore also recognizing a monthly fee instead of the entire purchase upfront. And we expect this trend to continue, which spreads the recognition of revenue over a longer period of time, but it's still providing the company with healthy gross margins and cash flow.

現在總銷售的經濟效益是相似的。然而，ClearPoint 可能會收取費用，因此也承認每月費用，而不是預付全部購買費用。我們預計這種趨勢將持續下去，這將在更長的時間內擴大收入的認可，但它仍然為公司提供了健康的毛利率和現金流。

If this strategy can accelerate the install of more ClearPoint systems, than a delay in the revenue recognition still fits our model, as the installation enables our disposables to be used and sold into the account.

如果此策略可以加速更多 ClearPoint 系統的安裝，那麼收入確認的延遲仍然適合我們的模型，因為安裝使我們的一次性用品能夠使用並銷售到帳戶中。

From a strategic standpoint, we submitted multiple new products to the FDA for clearance, including our smart frame product for an asset -- for navigation, designed in the operating room. Our ClearPoint 2.2 software with the integrated Maestro Brain Model, and our Array 1.2 software, which also actually achieved FDA clearance in the quarter.

從策略角度來看，我們向 FDA 提交了多種新產品以供審批，其中包括我們在手術室設計的用於資產導航的智慧框架產品。我們的 ClearPoint 2.2 軟體整合了 Maestro Brain 模型，我們的 Array 1.2 軟體也在本季獲得了 FDA 的批准。

We believe the timing of these submissions, will set us up for revenue traction of these products in 2024, with limited market release starting in the first half of the year, and full market releases in the second half of the year.

我們相信，這些提交的時間將為我們在 2024 年拉動這些產品的收入奠定基礎，上半年開始有限市場發布，下半年全面市場發布。

To highlight the theme of new revenue streams via the product launches, we currently do not have any revenue at all from the operating room only segment, which is an investment that we have been making for the past two years.

為了透過產品發布來突出新收入來源的主題，我們目前沒有來自純手術室細分市場的任何收入，這是我們過去兩年一直在進行的投資。

The new SmartFrame navigation product for the operating room will act as an additional source of revenue in this segment that will be new for us in 2024 and again, has already been submitted to the FDA for clearance.

用於手術室的新 SmartFrame 導航產品將成為該細分市場的額外收入來源，這對我們來說將在 2024 年成為新產品，並且已提交給 FDA 批准。

For pillar number three, therapy and access products, we continue to execute our limited market release of the Prism Laser Therapy System, and collect real-world product experience, as well as develop marketing and training materials.

對於第三支柱，治療和接觸產品，我們繼續執行棱鏡雷射治療系統的有限市場發布，並收集實際產品經驗，以及開發行銷和培訓材料。

Over the next six to nine months, we expect to submit multiple new hardware and software product improvements, which should enable full market release in the second half of 2024, as well as more substantial revenue traction.

在接下來的六到九個月內，我們預計將提交多項新的硬體和軟體產品改進，這應該能夠在 2024 年下半年全面上市，並帶來更可觀的收入牽引。

This is an exciting second-generation laser therapy system with many clear advantages compared to the currently available systems. While our installation experience has been limited, we have been able to win exclusive business, from some early users, who plan to use Prism, for all of their cases moving forward.

這是令人興奮的第二代雷射治療系統，與目前可用的系統相比具有許多明顯的優勢。雖然我們的安裝經驗有限，但我們已經能夠從一些計劃使用 Prism 的早期用戶那裡贏得獨家業務，以解決他們未來的所有案例。

The limited market release revenue for this year of 2023, that is built into our guidance is very minimal. So as we look to a full-market release in 2024, Prism laser therapy capital, rentals, and disposables will all be contributing an additional source of revenue, that will effectively be new and additive for 2024.

我們的指導中包含的 2023 年有限的市場發布收入非常小。因此，當我們期待 2024 年全面市場發佈時，Prism 雷射治療資本、租金和一次性用品都將貢獻額外的收入來源，這實際上將是 2024 年的新收入來源和附加收入來源。

And finally, pillar number four of achieving global scale, made significant progress as well. In the third quarter, we began production of sellable product in our new Carlsbad facility. And as of today, we have already shipped product to customers from the new site.

最後，實現全球規模的第四個支柱也取得了重大進展。第三季度，我們開始在卡爾斯巴德的新工廠生產可銷售的產品。截至今天，我們已經從新網站向客戶發貨。

I'm also pleased to report that as of today's call, we have also fully exited our Irvine facility, ahead of schedule, which will allow us to enter 2024, having removed many of these redundant manufacturing site costs and construction expenses.

我還很高興地報告，截至今天的電話會議，我們還提前完全退出了爾灣工廠，這將使我們能夠進入 2024 年，並消除許多多餘的製造場地成本和建設費用。

This entire facility transition has been an amazing example of execution, across our operations, development, quality, regulatory, and legal teams. With the transition behind us, we can now turn that execution towards the exciting new product launches, that we have planned for 2024.

整個設施的轉型是我們營運、開發、品質、監管和法律團隊執行力的一個令人驚嘆的例子。隨著過渡的結束，我們現在可以將執行轉向我們計劃於 2024 年推出的令人興奮的新產品。

As products get launched from the new site and revenue grows, we expect our gross margins to continue to improve. The gross margin in Q3 improved to 57% compared to 53% in Q2. So we are once again moving in the right direction.

隨著新網站推出產品和收入成長，我們預計毛利率將繼續提高。第三季毛利率由第二季的 53% 提高至 57%。因此，我們再次朝著正確的方向前進。

Mix of products, services, and capital from quarter to quarter will always have an impact. But directionally, we expect further gross margin improvement in 2024 and 2025. At this point, we believe that we have the team, the portfolio, and the infrastructure in place, to see our strategy play out for at least the next couple of years.

每季的產品、服務和資本組合總是會產生影響。但從方向上看，我們預計 2024 年和 2025 年毛利率將進一步提高。目前，我們相信我們的團隊、投資組合和基礎設施已經到位，可以看到我們的策略至少在未來幾年內發揮作用。

As a result it is our intention to keep our headcount, and our operating expenses relatively flat through 2025, while at the same time launching new products and revenue streams, as we fill our capacity of biologics and drug delivery services, launch our SmartFrame navigation platform into the operating room, execute a full market release of the Prism Laser Therapy System, and increase our customer base to 100 global sites.

因此，我們打算在 2025 年保持我們的員工數量和營運費用相對穩定，同時推出新產品和收入來源，因為我們填補了生物製劑和藥物輸送服務的產能，推出了我們的 SmartFrame 導航平台進入手術室，執行棱鏡雷射治療系統的全面市場發布，並將我們的客戶群增加到全球100 個站點。

With that, I would like to turn the call over to the operator for any questions.

因此，如果有任何問題，我想將電話轉給接線員。

(Operator Instructions)

（操作員說明）

Mathew Blackman, Stifel.

馬修布萊克曼，史蒂菲爾。

Good afternoon, everybody. Thank you so much for taking my questions. I've got three, a question on the quarter, and the outlook, and then a couple of bigger picture questions for you, Joe. If I could start on the quarter and the softer revenues in functional neuro, and now the lower 2023. I'm just trying to tease out how much of this is demand related versus perhaps a shift to more leases, or how much of it, if any is being toggled by your profitable growth strategy?

大家下午好。非常感謝您回答我的問題。我有三個問題，一個是關於本季的問題，一個是前景問題，然後還有幾個更宏觀的問題要問你，喬。如果我可以從本季和功能神經收入疲軟開始，現在是 2023 年。我只是想弄清楚其中有多少與需求相關，或者可能轉向更多租賃，或者其中有多少，您的獲利成長策略是否會改變任何因素？

Yes, I can go ahead and start and thanks for the question, Matt. Yeah, it's really a combination of a few things that have led us to go ahead and bring the guidance down slightly. As you mentioned, and as I mentioned earlier, in the remarks from the capital side of things, I would say that there has been a transition to more of these rental programs where, like I said, in the past we would have a $200,000 capital sale, for example, and once that system was sold and installed, it would actually all get recognized in that particular quarter.

是的，我可以繼續開始，謝謝你的提問，馬特。是的，這確實是一些因素的綜合作用，促使我們繼續稍微降低指導方針。正如你所提到的，正如我之前提到的，在資本方面的評論中，我想說的是，已經向更多此類租賃計劃過渡，就像我說的，過去我們將擁有 200,000 美元的資本例如，銷售，一旦該系統被出售並安裝，它實際上會在該特定季度得到認可。

Now we're talking about those same sort of economics, but in some cases, it's spread over two or three years. So we would maybe, only for this year, for example, recognized three months of one year of that or $15,000, $20,000, compared to the entire $200,000 in sales.

現在我們談論的是同類型的經濟學，但在某些情況下，它會持續兩到三年。因此，例如，我們可能只在今年確認一年中的三個月或 15,000 美元、20,000 美元，與整個 200,000 美元的銷售額相比。

So it's not to say that there's not going to be a mix, but I would say historically 90% to 95% of our deals had been on that capital side of things with an outright capital purchase, where as we not only continue to launch our navigation system, but also launch our laser therapy system into sites that maybe already purchased the laser therapy system from someone else a few years ago.

因此，這並不是說不會出現混合，但我想說，從歷史上看，我們 90% 到 95% 的交易都是在直接資本購買的資本方面，因為我們不僅繼續推出我們的導航系統，同時也將我們的雷射治療系統推出到幾年前可能已經從其他人那裡購買了雷射治療系統的網站。

It's tough to find the allocation for those capital dollars. So something that's more of a rental that can fit into the operating budget, is something that certainly takes place. I'd say that that's one element I'd point to. Another element is, again, last year, we had sort of a significant service side on our functional neurosurgery, tied to one particular brain computer interface project.

很難找到這些資本的分配。因此，更多的是可以適應營運預算的租金是肯定會發生的事情。我想說，這是我要指出的要素。另一個因素是，去年，我們的功能性神經外科有一個重要的服務方面，與一個特定的腦機介面專案相關。

That project had actually been paused earlier this year. So that's something that impacted our Q2 revenue. We now see that pause is going to last beyond, I think what the original communication I would say was, which was to kind of resume it in September in Q3. So now that we're not really expecting that to resume this year, we've kind of taken that particular number out as well. So that has been kind of the second impact.

該項目實際上已於今年稍早暫停。所以這影響了我們第二季的營收。我們現在看到這種暫停將持續下去，我想我想說的最初的溝通是，在 9 月的第三季恢復暫停。因此，既然我們並不真正期望這種情況會在今年恢復，我們也已經刪除了這個特定的數字。這就是第二個影響。

And then the third pack impact is really just timing. And that happens more on the biologics and drug delivery side of things. As we get more and more into services, and we add these capabilities, just the sheer dollar amount of a single deal or a single study, kind of explodes as a proportion of our revenues.

然後第三包的影響其實只是時機。這種情況更多地發生在生物製品和藥物傳輸方面。隨著我們越來越多地涉足服務領域，並添加這些功能，單筆交易或單項研究的絕對金額在我們收入中所佔的比例就會爆炸式增長。

So that to give you a tangible example, we have a committed PO in our hands, that has been signed know, part of the upfront payment is on the way, all those types of things, for a value of between $1.4 million and $1.5 million for one particular deal, one particular study.

舉個具體的例子，我們手裡有一份承諾的採購訂單，已經簽署，部分預付款正在支付中，所有這些類型的東西，價值在 140 萬美元到 150 萬美元之間對於一項特定的交易，一項特定的研究。

And from our standpoint, based on when the work actually takes place and the deliverable happens, sometimes we're not quite sure if that's going to happen December 20, or is that going to happen January 15.

從我們的角度來看，根據工作實際發生和可交付成果發生的時間，有時我們不太確定是在 12 月 20 日發生，還是在 1 月 15 日發生。

So just the way that those things can move around, the scale of that movement is sort of bigger than it has been in the past, because of these capabilities. And we're trying to be a little bit more conservative based on that as well because it's kind of the opposite what we're used to in the device world is, you sell a product, you ship it, and in many cases you end up getting the cash later, but you recognize it upfront.

因此，由於這些能力，這些東西可以移動的方式，移動的規模比過去更大。基於此，我們也試圖變得更加保守，因為這與我們在設備世界中習慣的方式相反，你銷售產品，你運送它，在很多情況下你結束了稍後才能收到現金，但您會提前認清它。

Some of the servicing is almost the opposite. We're actually getting down payments on some of these services in advance, but we might not be able to recognize the revenue at the same time. So it's kind of a little bit different than the device world, which we're seeing today.

有些服務幾乎相反。實際上，我們提前獲得了其中一些服務的首付款，但我們可能無法同時確認收入。所以它與我們今天看到的設備世界有點不同。

The other part of your question, which I think is an important one too, on the demand side of things, we haven't seen a huge change in demand, I would say from our core business. The case volume that we've seen has been relatively the same, relatively flat at this point. I think a lot of the things that we're doing are going to be adding to that, on the three points that I mentioned that I gave, as far as those new product launches in 2024.

你問題的另一部分，我認為這也很重要，在需求方面，我想說的是，從我們的核心業務來看，我們沒有看到需求發生巨大變化。目前我們看到的案件數量相對相同，相對持平。我認為，就 2024 年推出的新產品而言，我們正在做的許多事情都將根據我提到的三點進行補充。

I would also point out that we do have a significant queue of new systems that are on the horizon, and each new system, when you're opening a new store and you get that system shift, obviously it enables that volume to increase as well.

我還想指出的是，我們確實有大量即將推出的新系統，而每個新系統，當您開設新商店並且獲得系統轉變時，顯然它也會使該數量增加。

So I would say where we've been a little bit behind on the demand side this year, but it's been triggered more by this slower capital deployment process or new installations, more so than individual accounts slowing down their usage or demand of the product. So hopefully, that makes sense of a lot there. But people -- I'm happy to answer any follow-up questions.

所以我想說，今年我們在需求方面有點落後，但更多的是由於資本部署過程或新安裝速度較慢而引發的，而不是個人帳戶放慢了產品的使用或需求。希望這很有意義。但是大家——我很樂意回答任何後續問題。

I appreciate that, that was helpful. It's sort of a reasonably good segue to the next question, which is just on the more, let's call it, the more refined profitable growth strategy. How do you navigate that balance between growth and profitability

我很感激，這很有幫助。這是對下一個問題的一個相當好的延續，下一個問題只是關於更多，我們稱之為更精細的獲利成長策略。如何在成長和獲利之間取得平衡

Is there an ROI threshold you're using? Just curious how you're making these decisions now going forward? And then if I could ask a specific question on some of these new product rollouts, let's use the laser system as an example. How much about the launch costs are still to come? And I do have one more follow-up question.

您正在使用投資報酬率門檻嗎？只是好奇您現在該如何做出這些決定？然後，如果我可以就其中一些新產品的推出提出一個具體問題，讓我們以雷射系統為例。發射成本還有多少？我還有一個後續問題。

Yes. So I think the first question was around the threshold that we think about of what is profitable growth mean to some extent. And I think we've certainly responded to some questions we had in the past, when our overall gross margin had dipped down to 53%, I think in Q2.

是的。所以我認為第一個問題是我們思考獲利成長在某種程度上意味著什麼的門檻。我認為我們肯定已經回答了過去的一些問題，當時我們的整體毛利率下降到了 53%，我認為是在第二季。

And we mentioned one of the reasons for that was one or two significant biologics deals, which were kind of the right thing to do, at the time, to get our foot in the door with very, very large and established pharmaceutical companies, even at those particular entry fees or entry deals, for example, were at a lower gross margin.

我們提到原因之一是一兩筆重要的生物製劑交易，這在當時是正確的做法，可以讓我們踏入非常非常大的成熟製藥公司的大門，即使是在例如，這些特定的入場費或入場交易的毛利率較低。

Those are the types of things where I think we're evaluating a little bit differently, with today's capital markets, and a prioritization on cash flow. So would we do a deal that's in the 20% to 30% gross margin, especially one where you know, to get that deal going, we would have to actually hire new people and new team members, to add a new capability to accomplish it.

我認為，在當今的資本市場上，我們對這些類型的評估略有不同，並且優先考慮現金流。那麼，我們是否會做一筆毛利率在20% 到30% 的交易，尤其是你知道的交易，為了讓這筆交易進行下去，我們必須實際僱用新員工和新團隊成員，以添加新的能力來完成它。

That would be it would be an example of something where we'd say, hey, last year we would do it. But in light of today's environment, that might be enough for an outsized deal. But let's focus on the capabilities that we already have, so that these new deals that we sign on the biologic side, are in that 40%-, 50%-plus gross margin, as opposed to something that would maybe be a lower entry fee. I'd say that that's an example.

這將是一個例子，我們會說，嘿，去年我們會這樣做。但考慮到當今的環境，這可能足以達成一筆巨額交易。但是，讓我們專注於我們已經擁有的能力，以便我們在生物方面簽署的這些新交易的毛利率達到 40% 至 50% 以上，而不是可能較低的入場費。我想說這就是一個例子。

Similarly, we've got a very competitive product, I would say on the laser side of things. There's a few things that we need to do to access more of the market. So an example there is, right now we have approval for the three Tesla scanners.

同樣，我想說的是，在雷射方面，我們擁有非常有競爭力的產品。為了進入更多市場，我們需要做一些事情。舉個例子，現在我們已經批准了三台特斯拉掃描器。

But we have not yet done the regulatory and development work to -- not that we have to change the laser or anything, but there's additional work that has to be done to test a 1.5 scanner to get that approval. That's something where you say well, okay. Well, how quickly do we need to get that 1.5 approval right now, compared to securing cash for a little bit longer, for example.

但我們還沒有完成監管和開發工作——並不是說我們必須改變雷射或任何東西，而是需要做額外的工作來測試 1.5 掃描器以獲得批准。這就是你說得好，好吧。好吧，與獲得更長的時間的現金相比，我們現在需要多快才能獲得 1.5 的批准。

So the way I would think about it, which leads into your second question is rather, I think was around additional launch costs that we would expect to execute on these product launches. Pretty much what we're doing is we're sliding expenses one after the other, instead of adding them together.

因此，我思考這個問題的方式，這導致了你的第二個問題，我認為是圍繞著我們期望在這些產品發布上執行的額外發布成本。我們所做的幾乎就是一項地滑動支出，而不是將它們加在一起。

So for example, it's not to say we're not going to do the 1.5 Tesla study. We're actually in the process of planning that right now. The difference is that rather than doing it before we finished another project, we're going to wait till this one project is done, and then deploy those same resources to the second one in series, as opposed to doing a bunch of different things in parallel.

例如，這並不是說我們不會進行 1.5 特斯拉的研究。事實上，我們現在正在計劃之中。差別在於，我們不是在完成另一個項目之前就這樣做，而是等到這個項目完成後，然後將這些相同的資源部署到系列中的第二個項目，而不是在平行線。

So what I would say there are additional expenses, if you will, required to launch the products, but those expenses are really coming from people rolling off of current projects, and onto the new projects, instead of us hiring additional development engineers and things like that. But hopefully that helps.

所以我想說的是，如果你願意的話，推出產品需要額外的費用，但這些費用實際上來自於人們從當前項目轉入新項目，而不是我們僱用額外的開發工程師之類的事情。但希望這會有所幫助。

But that's kind of why we're saying, hey, we think we can keep the headcount and the expenses flat. There is some hiring that would come, just fulfilling additional products. But those new hires would likely be happening inside the gross margin line, as they're either a service provider or an operator on the line, that's designed to make more products. So those costs are accounted for elsewhere.

但這就是為什麼我們說，嘿，我們認為我們可以保持員工數量和費用不變。將會有一些招聘，只是為了完成額外的產品。但這些新員工可能會在毛利率範圍內發生，因為他們要么是服務提供商，要么是生產線的運營商，旨在生產更多產品。因此，這些成本在其他地方計算。

All right, really, really appreciate that, Joe. And I'm going to trying not to be greedy. I'll get back in the queue. Thanks again for taking my questions.

好吧，真的，真的很感激，喬。我會努力不貪婪。我會回到隊列中。再次感謝您回答我的問題。

Sure, thanks, Matt.

當然，謝謝，馬特。

William Wood, B. Riley Securities.

威廉·伍德，B.萊利證券。

Thanks so much for taking our questions, and congratulations on another quarter. A couple from us. I just actually follow up sort of on the expenses, which you were just discussing about. So those are rolling one from one project to the next, I'm just trying to think about was quarter over quarter burn and just sort of expenses overall.

非常感謝您提出我們的問題，並祝賀另一個季度。我們的一對。我實際上只是跟進了您剛才討論的費用。因此，這些項目正在從一個項目滾動到下一個項目，我只是想考慮四分之一的燒錢情況以及整體費用。

Just because as you know, if you do them all at once you have one or maybe two bad quarters, and then you increase up, but when you do them in parallel. Like should we be expecting this to sort of trickle alone for multiple, multiple quarters? Or is this more of a eliminating that other revenue and growth, or cuts or modifications will sort of balance out going forward? Just a little bit extra, I guess color on that.

如你所知，如果你同時做所有這些，你會經歷一個或兩個糟糕的季度，然後你就會上升，但是當你並行做它們時。就像我們是否應該期望這種情況會在多個、多個季度內單獨發生？或者這更多的是消除其他收入和成長，或削減或修改將在未來取得某種平衡？只是一點點額外的，我想是有顏色的。

Yeah, the way I think about it, it's tough to think about just Q3 or Q4, but you can think a little bit more annually or directionally here. 2024, 2025, these are the years where we expect the revenue to sort of significantly outpace expense growth.

是的，我的想法是，很難只考慮第三季度或第四季度，但你可以在這裡每年或定向地思考更多一點。 2024 年、2025 年，我們預期收入成長將顯著超過支出成長。

So that's where we get scale from these investments that we've really already made. So one side of the equation is yeah maybe we'll slow down a little bit of development, but the second part of that question is, does that really cost us anything on the topline revenue side in the next two years?

這就是我們從我們已經進行的這些投資中獲得規模的地方。所以等式的一方面是，也許我們會放慢一點發展速度，但問題的第二部分是，這真的會讓我們在未來兩年的營收方面付出任何代價嗎？

And the answer is as we look a little bit farther out is, I don't think it does. I think the competitiveness that we have heard from our early development efforts as we roll into the operating room, I think the competitiveness we've seen of our laser therapy system as we look at some of the other products that are on the market, and some early feedback that we've gone, and simple improvements we continue to make.

當我們看得更遠一點時，答案是，我認為不會。我認為，當我們進入手術室時，我們從早期開發工作中聽到了競爭力，我認為當我們看到市場上的其他一些產品時，我們看到了我們的雷射治療系統的競爭力，以及我們已經處理了一些早期回饋，並且我們繼續進行簡單的改進。

I think the addition, as I mentioned, have the capability to be able to do GLP studies on the biologic side, which significantly increases the revenue even for the same project if it's a GLP-1. So these are all things that I think are really additive to the revenue line, and coming from a year in 2023, where that base business really hasn't grown from a product standpoint.

我認為，正如我所提到的，添加項有能力在生物方面進行 GLP 研究，即使是同一項目（如果是 GLP-1），這也會顯著增加收入。因此，我認為這些都是對營收線真正有益的事情，而且來自 2023 年，從產品的角度來看，基礎業務確實沒有成長。

Just reintroducing and reaccelerating that through our software improvements, and through this queue of new hospitals that are going to get our navigation system, even for our traditional product and the MRIs. Those four things together, I think, put us in a position where if we can keep our operating expenses relatively flat, but then have these three to four avenues of new additive growth on top. That I think where we're going to see the impact.

只是透過我們的軟體改進，以及透過即將獲得我們的導航系統的新醫院的隊列，重新引入和重新加速這一點，即使是我們的傳統產品和核磁共振成像。我認為，這四件事加在一起，使我們處於這樣一個境地：如果我們能夠保持營運支出相對穩定，但同時擁有這三到四種新的附加成長途徑。我認為我們將在哪裡看到影響。

So yeah, so a long way of saying, I think we are making a couple of modest sacrifices right now, but we're doing that with the additional insight, that we're very pleased with the development we've made with our products, and maybe we just don't have to go as fast as we would have two or three years ago. Because we know these new products are going to be competitive and successful.

所以，是的，這麼長的說法，我認為我們現在正在做出一些適度的犧牲，但我們這樣做是帶著額外的洞察力，我們對我們產品的開發感到非常滿意，也許我們只是不必像兩三年前那樣快。因為我們知道這些新產品將具有競爭力並取得成功。

Right now, that's definitely helpful. So when thinking about your partnerships, sorry, you had mentioned that you're really going to sort of, I guess slow down the number of partnerships that you'll be looking to expand, and sort of shifting towards rather than more towards, I guess, more say, better value in your partnerships?

現在，這絕對有幫助。因此，在考慮您的合作夥伴關係時，抱歉，您提到過您確實會，我想會放慢您希望擴大的合作夥伴數量，並且會轉向而不是更多地轉向，我猜猜，更確切地說，你們的合作關係有更好的價值嗎？

I'm thinking about it going forward, I guess, sort of a two-part, how much should we think about the decrease in the new partnerships? Clearly, there's going to be new partnerships, but then also for your old partnerships, you be looking to add those sort of looking for it to be re-upped?

我想，我想，未來的事情分成兩部分，我們應該在多大程度上考慮新夥伴關係的減少？顯然，將會有新的合作夥伴關係，但對於您的舊合作夥伴關係，您是否希望添加那些尋求重新升級的合作關係？

Will you be looking to include better deals for yourself, and do you think when you when you reassess those, the sort of the terms of the deal, do you think you'll lose some of your customers, because of sort of the new structuring of what you're looking for?

您是否會為自己尋找更好的交易，當您重新評估這些交易條款時，您是否認為您會因為新的結構而失去一些客戶您正在尋找什麼？

Yeah, and I understand the question. I think and I mean, the way I think of it is, there's always a price to acquire a new customer, and that's whatever business you are in, and that's generally less on a percentage basis, than keeping an existing customer happy.

是的，我理解這個問題。我認為，我的意思是，我的想法是，獲得新客戶總是有代價的，無論你從事什麼業務，這通常都比讓現有客戶滿意要少。

So are our strategy to get into the preclinical services, and start working with companies, way before they ever even think about treating a human patient with clinical, with a cell and gene therapy, that strategy has always been to prove our value, prove that relationship, make ourselves an essential part of that team so that when these drugs get into their clinical trials, and the regulatory process and eventually commercial approval we've been there the entire ride.

我們進入臨床前服務並開始與公司合作的策略也是如此，早在他們考慮透過細胞和基因療法臨床治療人類患者之前，該策略一直是證明我們的價值，證明關係，使我們自己成為該團隊的重要組成部分，以便當這些藥物進入臨床試驗、監管流程和最終商業批准時，我們全程參與其中。

So each one of these natural partnerships that we already have in place, we want to continue to develop those. So I wouldn't say we're firing customers if you will, which is a term that's used commonly, but you know, as we talk about how to be as productive as we can, how much energy should we go, and making sure a company that we know is going to be successful that we've been able to see their own capability to see the progress we have made on the bench.

因此，我們希望繼續發展我們已經建立的每一個自然夥伴關係。因此，如果你願意的話，我不會說我們正在解僱客戶，這是一個常用的術語，但你知道，當我們談論如何盡可能提高生產力、我們應該投入多少精力以及確保一家我們知道將會成功的公司，我們能夠看到他們自己的能力，看到我們在替補席上的進步。

And preclinically, how much of our if we have a choice of how we're going to spend our time that day, furthering that relationship into a much more kind of lucrative long-term partnership, is better for us in the near term, than signing an early consultative agreement, and spending a lot of time and energy for a company that's just maybe not quite ready yet. So I'd say that's an example.

在臨床前，如果我們可以選擇如何度過當天的時間，將這種關係​​進一步發展為一種更有利可圖的長期合作夥伴關係，那麼在短期內對我們來說比簽署早期諮詢協議，並為一家可能還沒有完全準備好的公司花費大量時間和精力。所以我想說這是一個例子。

I think it's very similar to what we would do on the device side as well. If we're going to go and we're going to launch our navigation system into the operating room, are we going to focus on a small children's hospital in a rural area, that is only doing two or three surgeries a quarter, or we going to go after a site that was doing 100 surgeries a quarter.

我認為這與我們在設備端所做的非常相似。如果我們要去，我們要把導航系統啟動到手術室，我們是要關注農村地區的一家小型兒童醫院，每個季度只做兩到三次手術，還是我們我打算去尋找一個每季度進行100 例手術的網站。

The return on just our current teams, effort and energy, is much more beneficial with one hospital that can deliver 10 to 20 times the volume of that other one. So we want to go after that targeted ones during this period of time. But I think we're going to we're going to be doing that on both sides of the business.

如果一家醫院的治療量是另一家醫院的 10 到 20 倍，那麼我們現有的團隊、努力和精力的回報就會大得多。所以我們想在這段時間裡去尋找那些有針對性的人。但我認為我們將在業務雙方都這樣做。

Right. Makes sense. And then just thinking a little bit, I guess, ex US or international I mean, just curious a little bit any updates whether partnerships or regulatory approval, there's been some continued progress going on in Brazil, and then also and how sort of this, I guess, shift towards rental and some of these partnership changes, how you think that would be received ex US, do you think though fit in better or if there's been any feedback there.

正確的。說得通。然後想一下，我想，前美國或國際，我的意思是，只是好奇一點任何更新，無論是合作夥伴關係還是監管批准，巴西正在取得一些持續的進展，然後也是這樣，我想，轉向租賃和其中一些合作關係的變化，你認為在美國如何收到，你認為更適合或是否有任何回饋。

You know that's a great question William, the OUS is something where I'd say we're only doing what's required to support our pharma partners presently. So what I mean by that is, if we had unlimited capital dollars, yes, we could go and hire a full commercial team across Europe, and start selling navigation into centers for use in laser therapy or DDS or something like that.

你知道這是一個很好的問題，William，我想說的是，OUS 目前只是在支持我們的製藥合作夥伴所需的工作。所以我的意思是，如果我們有無限的資本，是的，我們可以在整個歐洲僱用一個完整的商業團隊，並開始向中心銷售導航，用於雷射治療或 DDS 或類似的東西。

In the current environment where we're being a little bit more thoughtful, pretty much what we're saying is, hey, we're going to respond to the pull and the needs of our pharma partners. And what that really looks like right now as a priority is 1 or 2 or 5, maybe pharma companies, 10 pharma companies that are interested in starting their clinical trials abroad, that pool of knowing where that site is.

在當前的環境下，我們更加深思熟慮，我們想說的是，嘿，我們將響應製藥合作夥伴的拉力和需求。現在真正優先考慮的是 1、2 或 5 家，也許是製藥公司，10 家有興趣在國外開始臨床試驗的製藥公司，知道該地點在哪裡。

And that they're going to have to use our navigation, and our cannulas for this from a clinical trial, allows us to have a strategy alongside that pharma partner, to be able to work with the regulatory authorities, and supported in that fashion. That's very different than sort of if you build it, they will come strategy of just hiring a team of folks, and knocking on doors, and trying to find some demand.

他們將不得不使用我們的導航和我們的臨床試驗插管，這使我們能夠與製藥合作夥伴一起制定策略，能夠與監管機構合作，並以這種方式提供支援。這與你建造它時的情況非常不同，他們會採取策略，只是僱用一個團隊，敲門，試圖找到一些需求。

So I think that that's an example of where I'd say, we've probably making some, if enough, probably we have made some decisions to slow our traditional commercial efforts abroad, and focused more of those efforts and resources here in the United States, where the product portfolio is a bit more complete, and we have line of sight to these new FDA submissions, which I shared are already in to the FDA.

所以我認為這就是我想說的一個例子，我們可能已經做出了一些決定，如果足夠的話，我們可能已經做出了一些決定來減緩我們在海外的傳統商業努力，並將更多的努力和資源集中在美國。產品組合更完整的州，我們可以看到這些新的 FDA 提交文件，我分享的這些文件已經提交給 FDA。

Got it. That's really helpful. I think I'll leave it there. I appreciate you taking our question. Thanks very much.

知道了。這真的很有幫助。我想我會把它留在那裡。感謝您回答我們的問題。非常感謝。

Sure. Thanks, William.

當然。謝謝，威廉。

Frank Takkinen, Lake Street Capital Markets.

Frank Takkinen，湖街資本市場。

Great. Thanks for taking the questions. And apologies if I am a little repetitive. I've been hopping between calls, but I was hoping you could talk a little bit more about the laser business. I know you spoke about some competitive pressures in that business as well as when you do end up moving toward the OR, and just thinking about prudently investing in those areas.

偉大的。感謝您提出問題。如果我有點重複，請道歉。我一直在打電話，但我希望你能多談談雷射業務。我知道您談到了該業務中的一些競爭壓力，以及當您最終轉向 OR 時，只是考慮在這些領域進行謹慎投資。

But maybe just talk more about what you're learning in that initial pilot launch? And if that's changed your strategy, I want to flip to a full commercial launch in that laser market, given some of the competitive factors offset, by some of your cost controls that you're speaking to?

但也許只是更多地談談您在最初的試點啟動中學到了什麼？如果這改變了您的策略，考慮到您正在談論的一些成本控制所抵消的一些競爭因素，我想轉向在該雷射市場上進行全面的商業發布？

Yeah. No, I don't -- I think there's one, I mean let me answer the question in a few different parts here. So the first is I think the market is actually still a very interesting, and potentially exciting market. I know the results of the actual market expansion over the past few years, has been jaded a little bit by COVID, and certainly more growth on the tumor side, than on the epilepsy side of ablations.

是的。不，我不知道——我認為有一個，我的意思是讓我在這裡分幾個不同的部分來回答這個問題。首先，我認為這個市場實際上仍然是一個非常有趣、並且可能令人興奮的市場。我知道過去幾年實際市場擴張的結果因新冠疫情而有些疲倦，而且腫瘤方面的增長肯定比消融的癲癇方面更多。

But nonetheless, I still think it's in the market certainly worthy of investment. And if you're starting from zero, you've got a lot of places an existing share that can be taken, let alone the market growth itself. So from that standpoint, I wouldn't say that there's a big change in the way that we've spoken about in the past.

但儘管如此，我仍然認為它在市場上絕對值得投資。如果你從零開始，你就有很多可以佔據的現有份額，更不用說市場成長本身了。因此，從這個角度來看，我不會說我們過去談論的方式有很大的變化。

From a competitiveness of our system, I think we've gotten some very, very good early results. And we've been able to highlight how our particular device performs in certain patient types, and being able to document that performance, and collect feedback on why certain parts of the software, or certain parts of the laser design, or flexibility of the capital and hardware itself, how those things provide a meaningful advantage for us in the near term. So I feel I feel very good about that as well.

從我們系統的競爭力來看，我認為我們已經取得了一些非常非常好的早期成果。我們已經能夠強調我們的特定設備在某些患者類型中的表現，並能夠記錄該表現，並收集關於為什麼軟體的某些部分、雷射設計的某些部分或資本的靈活性的反饋以及硬體本身，這些東西如何在短期內為我們提供有意義的優勢。所以我覺得我對此也感覺很好。

And as far as an access and speed of access standpoint, there's two different [axes] that I would consider. One is one that I did mention a little bit ago, which is there's two types of scanner powers that are out there. There's the 3 Tesla scanners and the 1.5 Tesla.

就訪問和訪問速度的角度而言，我會考慮兩個不同的[軸]。其中之一是我之前提到的，即有兩種類型的掃描器功能。有 3 個 Tesla 掃描器和 1.5 Tesla 掃描器。

We currently only have approval for the 3 Tesla power, which you can argue is the more complicated to do with the bigger system. But nonetheless that is where we decided to start. So all of our installs to date have been in 3 Tesla scanners, and for a customer that's interested in using us, but in 1.5, we have to simply say, hey, you know, it's on our horizon, but it's not something that we have, or we have available to you.

我們目前只批准了 3 特斯拉動力，您可能會說，對於更大的系統來說，這樣做會更複雜。但儘管如此，我們還是決定從這裡開始。因此，迄今為止我們所有的安裝都是在3 個Tesla 掃描器中進行的，對於有興趣使用我們的1.5 掃描儀的客戶，我們必須簡單地說，嘿，你知道，它就在我們的視野中，但這不是我們想要的。有，或者我們可以為您提供。

So that's kind of one access where we only have part of the market, or access to part of the market. The other access is where does the entire laser procedure take place. So in the past we've talked about the laser market as ClearPoint navigation having an inherent advantage, because even if the laser catheter is placed in the operating room, the patient still has to be transported to the MRI suite, because that's where the laser is turned on inside of the MRI, to give you all of the crucial heat information, or the thermometry information.

因此，這是一種我們只擁有部分市場或進入部分市場的機會。另一個通道是整個雷射手術進行的地方。所以過去我們談到雷射市場時ClearPoint導航具有先天的優勢，因為即使雷射導管被放置在手術室中，患者仍然必須被運送到MRI套件，因為那是雷射的地方在MRI 內部打開，為您提供所有重要的熱資訊或測溫資訊。

So the other advantage we have a ClearPoint is to say, well, if you do it with ClearPoint, you can do the entire procedure in the MRI, and you don't have to worry about transporting that patient, right? That was kind of an inherent advantage that we thought made a lot of sense.

所以我們擁有 ClearPoint 的另一個優點是，如果你用 ClearPoint 來做，你可以在 MRI 中完成整個過程，而且你不必擔心運送病人，對吧？這是我們認為很有意義的固有優勢。

And it still makes sense what we've run into practically I would say is that some hospitals, if it's an older diagnostic magnet and diagnostic room, it sounds a little strange, but trust me on this one. The hospital will allow you to do the ablation of the patients in the MRI, but they won't let you do the placement of the device.

我們實際上遇到的情況仍然是有道理的，我想說的是，有些醫院，如果它是較舊的診斷磁鐵和診斷室，這聽起來有點奇怪，但請相信我。醫院會允許你在核磁共振成像中對病人進行消融，但他們不會讓你做裝置的放置。

So it's almost like they say, it's based on the airflow of the hospital, or other state by state parameters, they might say, hey, this older room is simply not designed for this, so you're not allowed to drill the holes or insert the catheter in the diagnostic magnet. You have to do that, and you have to do that in the operating room and then transport the patients.

所以這幾乎就像他們說的那樣，它是基於醫院的氣流或其他州的參數，他們可能會說，嘿，這個舊房間根本不是為此設計的，所以不允許你鑽孔或將導管插入診斷磁體中。你必須這樣做，你必須在手術室裡這樣做，然後運送病人。

I think that realization has been a little newer to us, but the reaction for us is to say well, that's fine. We will simply provide you next year with an option, to be able to place our laser catheter in the operating room as well. We're working on our own operating room navigation.

我認為這種認識對我們來說有點新，但我們的反應是說好吧，那很好。我們將在明年為您提供一個選項，以便能夠將我們的雷射導管放置在手術室中。我們正在開發自己的手術室導航。

So it's another example of interest, instead of trying to force change at how a doctor is doing their procedure today, we're simply going to adapt our product to fit into their existing workflow. So that's the other access. If you think about it, we probably today only have access to 10% or 20% of the overall patient volume, as part of our limited market release.

因此，這是另一個有趣的例子，我們不是試圖強制改變醫生今天的手術方式，而是簡單地調整我們的產品以適應他們現有的工作流程。這就是另一種訪問方式。如果你想一想，作為我們有限市場發布的一部分，我們今天可能只能接觸到總患者量的 10% 或 20%。

But as we add 1.5 Tesla, and as we add our operating room navigation, and operating room laser solution, we'll go from 10% access, to 80% or 90% access pretty quickly. So that's a big part of our 2024 strategy.

但當我們添加 1.5 特斯拉、添加手術室導航和手術室雷射解決方案時，我們的訪問率很快就會從 10% 提高到 80% 或 90%。這是我們 2024 年策略的重要組成部分。

Got it. Okay. That's helpful. And then maybe, shift to the OR opportunity, I think we've spoke about this in the past, but I think it's worth talking about again. Let's talk about once you have that entire our portfolio of products in place to do those placements in the operating room, can you just talk about how the selling process changes at that point, and your excitement around when that is commercialized?

知道了。好的。這很有幫助。然後也許，轉向 OR 機會，我想我們過去已經討論過這個問題，但我認為值得再次討論。讓我們談談，一旦您擁有了我們的整個產品組合來在手術室中進行這些放置，您能談談當時銷售流程如何變化，以及當其商業化時您的興奮嗎？

Yeah, I think that will help us quite a bit. First from just a market dynamic standpoint, 95%-plus. If you look at laser, and biopsy, and deep brain stimulation, the three primary procedures that stereotactic navigation is used for, more than 95% is in the operating room today.

是的，我認為這對我們有很大幫助。首先從市場動態的角度來看，95%以上。如果你看看雷射、活組織檢查和深部腦部刺激，立體定位導航用於的三個主要手術，今天超過 95% 是在手術室進行的。

So we're dominant in the MRI navigation, but it's a tiny, tiny little piece of the market today. So first off, it allows us to go where the procedures are actually taking place, which is obviously an important part. I think MRI guidance will continue to grow. There's certain procedures doctors will tell you.

因此，我們在 MRI 導航領域佔據主導地位，但它在當今市場中只佔很小的一部分。首先，它允許我們到達程序實際發生的地方，這顯然是一個重要的部分。我認為 MRI 指導將會繼續成長。醫生會告訴您某些程序。

Yeah, I do some of my stuff in the OR, but when this patient comes in and needs this particular therapy, I'm doing this one in the MRI where the states -- that when the stakes are highest. And I think that that's going to continue to be the case, because those procedures are growing, et cetera.

是的，我在手術室做了一些工作，但是當這位患者進來並需要這種特殊的治療時，我會在 MRI 中進行這項治療，其中指出，當風險最高時。我認為這種情況將繼續存在，因為這些程序正在增長，等等。

But as far as where the volume is today, that is in the operating room. And this new tool, or series of tools will allow us to directly go after that. So that's one element is we'll be playing where the procedures are. The second part is we'll be able to play at a kind of a lower price point to some extent in that space.

但就今天的音量而言，那是在手術室裡。這個新工具或一系列工具將使我們能夠直接實現這一目標。因此，其中一個要素是我們將在程式所在的地方進行操作。第二部分是我們將能夠在該領域以某種較低的價格點進行遊戲。

Which again makes it much more competitive to existing procedures, and existing budgets that maybe are a little bit more routine, where doctors might say, hey, I would love to have the precision of ClearPoint MRI guidance. But for this particular patient, I can probably get away with a little bit, maybe less precise, less accurate option.

這再次使其比現有程序更具競爭力，並且現有預算可能更加常規，醫生可能會說，嘿，我希望擁有 ClearPoint MRI 指導的精確度。但對於這個特殊的病人，我可能可以採取一些可能不太精確、不太準確的選擇。

And certainly if that's the type of procedure I can save a little money on, and having a lower ASP. As a hospital operator, I require that to balance out the overall costs. So this will also allow us to play there, and one of the reasons that allows us to play there, is that the workflow is a bit simpler, if you're not worried about communicating to an MRI magnet, and adjusting coils for image quality, and all those types of things.

當然，如果這是我可以節省一點錢的程式類型，並且具有較低的 ASP。作為醫院經營者，我要求平衡整體成本。因此，這也將允許我們在那裡玩，而允許我們在那裡玩的原因之一是，如果您不擔心與 MRI 磁體通信以及調整線圈以提高圖像質量，那麼工作流程會更簡單一些，以及所有這些類型的事情。

So what that means is that we would not have to supply a clinical specialist for every single procedure, which brings our overall costs down. So I think in the operating room, you're going to see more of a model, where ClearPoint is there for the first 5 procedures, the first 10 procedures, something like that.

因此，這意味著我們不必為每一個手術提供一名臨床專家，這降低了我們的整體成本。所以我認為在手術室裡，你會看到更多的模型，其中 ClearPoint 用於前 5 個程序、前 10 個程序，類似的東西。

But our clinical support, because of the lower ASP. clinical support starts to roll off over time. And we'll still train on new software and new developments and things like that, but it won't be a necessity that we have to be there for every case. So our clinical team will focus on laser cases and these more complicated MRI procedures, and not so much having that added clinical cost in the operating room. So that's another very, very key difference.

但我們的臨床支持，因為 ASP 較低。隨著時間的推移，臨床支持開始減少。我們仍然會接受有關新軟體和新開發之類的培訓，但我們不必針對每種情況都在場。因此，我們的臨床團隊將專注於雷射病例和這些更複雜的 MRI 程序，而不是在手術室增加臨床成本。這是另一個非常非常關鍵的區別。

And then the final one I bring up is in some cases, our system will not require new ClearPoint software to be used, but rather we'll be able to use our hardware with our disposable hardware I mean, alongside other navigation systems that are already in the hospital.

然後我提出的最後一個問題是，在某些情況下，我們的系統不需要使用新的ClearPoint 軟體，而是我們能夠將我們的硬體與我們的一次性硬體一起使用，我的意思是，以及其他已經存在的導航系統在醫院。

So everything I was talking about before of capital budgets, and it may be delaying revenue recognition, because we didn't want to do rentals, all of that goes away. If we can just walk in and say, hey, here's a new, better mousetrap on the disposable side, and it can work with some of the existing hardware and software that's already in your lap.

因此，我之前談論的所有資本預算，可能會延遲收入確認，因為我們不想進行租賃，所有這些都會消失。如果我們可以走進來說，嘿，這裡有一個新的、更好的一次性捕鼠器，它可以與你腿上已有的一些現有硬體和軟體配合使用。

So we don't even deal with the capital process and that end point. So those are kind of the three elements I would point to, on the on the operating room side of things.

所以我們甚至不處理資本流程和終點。這些是我在手術室方面要指出的三個要素。

Got it. And I'll stop there, and thanks for taking the questions.

知道了。我就到此為止，感謝您提出問題。

Thanks, Frank.

謝謝，弗蘭克。

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

目前沒有其他問題。我現在想將電話轉給喬·伯內特（Joe Burnett）發表結束語。

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 products and service launches, across all four of our growth pillars.

再次感謝所有有興趣參與 ClearPoint 團隊旅程的人。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。

We've worked hard to get to this spot, and are incredibly excited for the team, but also for the patients that we hope to treat with new devices and therapies in the very near future. Then end of the -- at the end of the day, the patient and their family are why we are here, and ultimately who we are working for. So with that, thank you and have a good evening.

我們經過努力才達到這個目標，我們為團隊感到無比興奮，也為我們希望在不久的將來用新設備和療法治療的患者感到興奮。歸根究底，患者及其家人是我們在這裡的原因，也是我們最終為之工作的對象。所以，謝謝您，祝您晚上愉快。

I would like to thank our speakers for today's presentation, and thank you all for joining. This now concludes today's call, and you may now disconnect.

我要感謝今天的演講者的演講，並感謝大家的加入。今天的通話到此結束，您現在可以掛斷電話了。