Clearpoint Neuro Inc (CLPT) 2023 Q2 法說會逐字稿

Greetings, and welcome to the ClearPoint Neuro, Inc. Second Quarter 2023 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. Comments made on this call may include statements that are forward-looking within the meaning of securities laws.

您好，歡迎您參加 ClearPoint Neuro, Inc. 2023 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。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 total addressable markets or the market opportunity for the company's products and services, 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行業趨勢、公司的初步和預期的計劃、前景和策略、潛在市場總量或公司產品和服務的市場機會、管理層的期望相關的陳述、關於未來經營結果的信念、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 3 months ended March 31, 2023, both of which have been filed with the Securities and Exchange Commission and the company's quarterly report on Form 10-Q for the 3 months ended June 30, 2023, which the company intends to file with the Securities and Exchange Commission on or before August 14, 2023.

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10-K表格年度報告以及截至2023年3月31日止3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2023年6月30日止3個月的10-Q表格季度報告，該公司計劃於2023年8月14日或之前向美國證券交易委員會提交該報告。

All the company's filings may be obtained on the SEC or the company's website at www.clearpointneuro.com. I would now like to turn the call over to your host, Joe Burnett, Chief Executive Officer. Please go ahead.

本公司的所有文件均可在 SEC 或公司網站 www.clearpointneuro.com 上取得。現在我想將電話轉給主持人喬·伯內特（Joe Burnett），執行長。請繼續。

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

謝謝大家，也謝謝參加今天電話會議的所有投資人和分析師。也感謝您參與 ClearPoint 願景和旅程。我們的使命和首要任務是幫助患有一些可以想像到的最令人衰弱的神經系統疾病的患者及其家人恢復生活品質。

In the second quarter of 2023, the company returned to double-digit growth and delivered record revenue of $6 million in the quarter. We have also continued to make progress across our 4-pillar growth strategy, including Pillar 1, biologics and drug delivery; Pillar 2, functional surgery navigation; Pillar 3, therapy and access products; and Pillar 4, achieving global scale.

2023 年第二季度，該公司恢復兩位數成長，並在該季度實現創紀錄的 600 萬美元收入。我們也持續在四大支柱成長策略方面取得進展，包括第一支柱、生物製劑和藥物傳遞；支柱2，功能性手術導航；第三支柱，治療和接取產品；第四支柱，實現全球規模。

I will now turn the call over to Danilo D'Alessandro, our CFO, to review our financial performance in the quarter, after which I will add some detail to our 4-pillar growth strategy and expectations for the second half of 2023. Danilo?

現在，我將把電話轉給我們的財務長達尼洛·達歷山德羅(Danilo D'Alessandro)，以回顧我們本季度的財務業績，之後我將添加一些關於我們的4 支柱增長戰略和2023 年下半年預期的細節。達尼洛？

Thank you, Joe, and thank you all for joining us today. Looking at the second quarter 2023 results. Total revenue was $6 million for the 3 months ended June 30, 2023, and $5.2 million for the 3 months ended June 30, 2022, which represents 14% growth versus the second quarter of 2022. As a reminder, our revenues made up of 3 components: biologics and drug delivery, functional neurosurgery navigation and therapy, and capital equipment and software.

謝謝你，喬，也謝謝大家今天加入我們。看看2023年第二季的業績。截至2023 年6 月30 日的3 個月的總收入為600 萬美元，截至2022 年6 月30 日的3 個月的總收入為520 萬美元，較2022 年第二季度增長14%。提醒一下，我們的收入由 3組成部分：生物製劑和藥物傳輸、功能性神經外科導航和治療以及資本設備和軟體。

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 40% to $3.4 million in the second quarter, up from $2.4 million in 2022. This increase was fueled by 155% increase in biologic 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 a $0.9 million decrease in product revenue.

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。第二季生物製品和藥物輸送收入成長了40%，達到340 萬美元，高於2022 年的240 萬美元。隨著我們擴大製藥客戶的服務，生物製品和藥物輸送服務收入成長了155% ，推動了這一增長。生物製劑和給藥服務的成長被產品收入減少 90 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 to the desired target. This revenue segment increased 1% to $2.2 million for the second quarter.

功能性神經外科導航收入包括與利用 ClearPoint 系統向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。第二季該部門的營收成長了 1%，達到 220 萬美元。

Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services decreased 38% to $0.4 million in the quarter from $0.6 million for the same period in 2022, reflecting fewer placements of ClearPoint capital and software.

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）在本季下降了38%，從2022 年同期的60 萬美元降至40 萬美元，反映出ClearPoint 資本和軟體的投放減少。

Gross margin for the second quarter of 2023 was 53% as compared to a gross margin of 63% for the second 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 product sales as we increase our presence in this space.

2023 年第二季的毛利率為 53%，而 2022 年第二季的毛利率為 63%。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，隨著我們增加在這一領域的業務，我們的利潤率低於產品銷售。

Increase and duplicate costs related to the transition to the new manufacturing facility also contributed to the decrease in gross margin in the quarter. Research and development costs were $3.6 million for the 3 months ended June 30, 2023, compared to $2.4 million for the same period in 2022, an increase of $1.2 million or 50%. The increase was due primarily to increases in personnel costs, including share-based compensation of $0.8 million, increase in product development cost of $0.4 million as we invest in our technology platforms, particularly our software and biologics and drug delivery offering.

與向新製造工廠過渡相關的成本增加和重複成本也導致了本季毛利率的下降。截至 2023 年 6 月 30 日的三個月，研發成本為 360 萬美元，而 2022 年同期為 240 萬美元，增加了 120 萬美元，即 50%。這一成長主要是由於人員成本的增加，包括80 萬美元的股權激勵，以及由於我們投資於我們的技術平台，特別是我們的軟體、生物製劑和藥物輸送產品而導致的產品開發成本增加40 萬美元。

Sales and marketing expenses were $3.5 million for the second quarter compared to $2.4 million for the same period in 2022, an increase of $1.1 million or 46%. This increase was due to additional personnel costs in consumer-based compensation as we expand our commercial reach and preparation for multiple new product launches over the next 18 months.

第二季銷售和行銷費用為 350 萬美元，而 2022 年同期為 240 萬美元，增加了 110 萬美元，即 46%。這一增長是由於我們擴大商業範圍以及為未來 18 個月內推出多種新產品做準備而導致基於消費者的薪酬增加了人員成本。

The extended 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.

延長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，該產品組合將針對醫院內的新醫生客戶和新手術領域。

General and administrative expenses were $3.2 million for the second quarter compared to $2.7 million for the same period in 2022, an increase of $0.5 million or 19%. This increase was due primarily to an increase in share-based compensation of $0.2 million and an increase in the allowance for credit losses of $0.2 million.

第二季一般及管理費用為 320 萬美元，而 2022 年同期為 270 萬美元，增加了 50 萬美元，即 19%。這一增長主要是由於股權激勵增加了 20 萬美元，信貸損失準備金增加了 20 萬美元。

Net interest income for the 3 months ending in June 2023 was $0.1 million compared to [$0.1] million net interest expense for the same period in 2022. With respect to our cash position as of June 30 2023, we held cash, cash equivalents and short-term investments of $26.5 million compared to $37.5 million as of December 31, 2022.

截至 2023 年 6 月的 3 個月淨利息收入為 10 萬美元，而 2022 年同期的淨利息支出為 10 萬美元。截至 2023 年 6 月 30 日，我們持有現金、現金等價物和空頭頭寸。截至2022 年12 月31 日，長期投資為2,650 萬美元，而截至2022 年12 月31 日為3,750 萬美元。

While our operational cash burn in the second quarter was broadly in line with the prior year, we expect our operational cash burn to reduce meaningfully in the second half of 2023 compared to our first half of 2023. The reduction of operational cash burn will be driven by: one, the easing of supply chain conditions that allows us to gradually reduce the inventory; two, operating leverage due to higher revenue; and three, our existing headcount should be sufficient to support our business into 2024.

雖然我們第二季的營運現金消耗與去年基本一致，但我們預計 2023 年下半年我們的營運現金消耗將比 2023 年上半年大幅減少。營運現金消耗的減少將推動通過：一是供應鏈條件的寬鬆，使我們能夠逐步減少庫存；二是收入增加導致經營槓桿；第三，我們現有的員工人數應該足以支持我們的業務到 2024 年。

In addition, in the second quarter of 2023, we invested $0.3 million to set up our new manufacturing site in Carlsbad, California. With that, I'd like now to turn the call back to Joe.

此外，2023年第二季度，我們投資了30萬美元在加州卡爾斯巴德建立了新的製造基地。有了這個，我現在想把電話轉回給喬。

Thanks, Danilo. The second quarter of 2023 was a record quarter for ClearPoint Neuro, with $6 million in sales, driven by 40% plus growth in our biologics and drug delivery business, which is where the majority of our hiring and investment has taken place in 2023.

謝謝，達尼洛。 2023 年第二季度是ClearPoint Neuro 創紀錄的季度，銷售額達600 萬美元，這主要得益於我們的生物製劑和藥物輸送業務增長40% 以上，而我們2023 年的大部分招聘和投資都發生在該業務上。

Let's start the conversation with that first pillar of growth, biologics and drug delivery. We continue to gain traction and earn business from more than 50 pharma and academic partners who are using our ClearPoint Neuro products and services. We expect these partnerships to not only grow in number, but in scale and sophistication.

讓我們從成長、生物製劑和藥物傳遞的第一個支柱開始對話。我們繼續從使用我們的 ClearPoint Neuro 產品和服務的 50 多家製藥和學術合作夥伴那裡獲得吸引力並贏得業務。我們預計這些合作夥伴關係不僅會在數量上有所增長，而且會在規模和複雜程度上有所增長。

A perfect example of this is a recently signed agreement for a multi-platform gene therapy program. This is a blueprint strategic partnership, whereby ClearPoint Neuro will earn a cash payment for milestones tied to the clinical and regulatory success of the drug product itself.

最近簽署的多平台基因治療計畫協議就是一個完美的例子。這是一個藍圖策略合作夥伴關係，ClearPoint Neuro 將為與藥物本身的臨床和監管成功相關的里程碑賺取現金付款。

Importantly, these milestones do not begin a commercial approval of the drug, but throughout the drug development process where ClearPoint Neuro specialists play an integral role. This agreement is a clear and concrete example of how a drug candidate successfully navigating the regulatory process can contribute meaningfully to our results.

重要的是，這些里程碑並不是藥物獲得商業批准的開始，而是在整個藥物開發過程中，ClearPoint Neuro 專家發揮著不可或缺的作用。該協議是一個明確而具體的例子，說明了成功通過監管流程的候選藥物如何為我們的成果做出有意義的貢獻。

This would only be possible because of our focus and our investment in a preclinical touch point that starts very early in the drug development process and is yielding terrific results thus far. While delays or even cancellations of some programs are expected, we believe our unique product portfolio and our expanded yet neuro service offerings make us the premier partner for drug companies in the space.

這之所以成為可能，是因為我們對臨床前接觸點的關注和投資，該接觸點在藥物開發過程的早期就開始，並且迄今為止正在產生出色的結果。雖然預計某些項目會延遲甚至取消，但我們相信我們獨特的產品組合和不斷擴大的神經服務產品使我們成為該領域製藥公司的首要合作夥伴。

For perspective, 1 partnership could generate more than $10 million per program in potential revenue to ClearPoint in products, services and milestones before the drug is ever commercially available. If all 50 current partners were to progress through Phase III trials for their drug candidate, then the potential for ClearPoint Neuro could be in the hundreds of millions of dollars over the next 10 years just from preclinical and clinical work.

從長遠來看，在該藥物投入商業使用之前，1 個合作夥伴關係可以為 ClearPoint 在產品、服務和里程碑方面為每個項目帶來超過 1000 萬美元的潛在收入。如果所有 50 個現有合作夥伴都能夠通過其候選藥物的 III 期試驗，那麼 ClearPoint Neuro 在未來 10 年內僅從臨床前和臨床工作中就可能獲得數億美元的潛力。

The key message here is that we are not depending on commercial drug approval to reach operational cash flow breakeven and can achieve that key milestone prior to any large incidence drug approvals. One example of this progression through the regulatory pathway is the announcement earlier this morning from one of our clinical stage partner companies, Aspen Neuroscience, who are based here in San Diego. They announced IDE approval from the FDA for their Phase I/IIa clinical trials to treat moderate to severe Parkinson's disease. We are thrilled to be working with them on this important clinical study.

這裡的關鍵訊息是，我們不依賴商業藥物批准來實現營運現金流盈虧平衡，並且可以在任何大宗藥物批准之前實現這一關鍵里程碑。今天早些時候，我們的一家臨床階段合作夥伴公司 Aspen Neuroscience（總部位於聖地牙哥）宣布了這項監管途徑進展的一個例子。他們宣布 IDE 批准其治療中度至重度帕金森氏症的 I/IIa 期臨床試驗。我們很高興能與他們合作進行這項重要的臨床研究。

Now in the event that a drug company achieves commercial approval, then the potential is much greater, we do remember that the goal of many of these advanced gene and cell therapies is not only to address symptoms, but to sometimes cure the underlying disease itself. If a onetime administration of a drug could safely cure these debilitating diseases like Huntington's disease, Parkinson's disease, epilepsy, et cetera, then the demand for these treatments will be much greater than for the device and surgical interventions used today that sometimes simply control the symptoms.

現在，如果一家製藥公司獲得商業批准，那麼潛力就會更大，我們確實記得，許多先進的基因和細胞療法的目標不僅是解決症狀，有時還可以治癒潛在的疾病本身。如果一次性服用藥物可以安全地治癒這些使人衰弱的疾病，如亨廷頓氏症、帕金森氏症、癲癇等，那麼對這些治療的需求將遠遠大於當今使用的有時只是控制症狀的設備和手術幹預措施。

As an example, there are over 1 million patients in the United States alone living with Parkinson's disease and yet only about 7,000 are treated annually with deep brain stimulation to control the symptoms. That is less than 1% of the total population struggling with this disease. We believe that proven drug alternatives that are endorsed and even prescribed by a more common neurologist and not just the neurosurgeon will dramatically expand the number of patients seeking or even demanding treatment.

例如，光在美國就有超過 100 萬名患者患有帕金森氏症，但每年只有約 7,000 人接受深部腦部刺激治療以控制症狀。這不到總人口的 1% 與這種疾病作鬥爭。我們相信，經過驗證的藥物替代品得到更常見的神經科醫生（而不僅僅是神經外科醫生）的認可甚至處方，將大大增加尋求甚至要求治療的患者數量。

The neurologist is key to driving that education and demand. Hiring a commercial team focused on neurologists is a very expensive endeavor and difficult to scale. ClearPoint Neuro has the benefit of many pharmaceutical partners that already have a neurology channel to get the face time and presence we need to build awareness and build the market itself. The commercial economics of ClearPoint Neuro can change as well in a commercial setting.

神經科醫生是推動教育和需求的關鍵。聘請專注於神經科醫生的商業團隊是一項非常昂貴的工作，而且難以擴展。 ClearPoint Neuro 擁有許多製藥合作夥伴的優勢，這些合作夥伴已經擁有神經病學管道，可以為我們提供建立知名度和建立市場所需的面對面時間和存在。 ClearPoint Neuro 的商業經濟學在商業環境中也可能發生變化。

This is due not only to our expertise, our experience and our intellectual property, but also for regulatory reasons. When the PTC drug Upstaza was granted CE Mark approval for commercialization, the ClearPoint Neuro SmartFlow Cannula was written directly into the label of the drug as part of the European marketing authorization.

這不僅是由於我們的專業知識、經驗和智慧財產權，也是出於監管原因。當 PTC 藥物 Upstaza 獲得商業化 CE 標誌批准時，ClearPoint Neuro SmartFlow 插管會直接寫入該藥物的標籤中，作為歐洲行銷授權的一部分。

To say it differently, our SmartFlow is the only cannula that is to be used for delivery of Upstaza into the brain in the European Union. The regulatory reason for this is the battery of bench preclinical and clinical testing that is done to show drug compatibility with the delivery device, all of which we gather and organize for the notified body or for the FDA. This is not a small task and is essential to documenting the safety and predictability of the drug and device interaction.

換句話說，我們的 SmartFlow 是歐盟唯一用於將 Upstaza 輸送到大腦中的插管。監管原因是進行一系列臨床前和臨床測試，以顯示藥物與輸送設備的兼容性，所有這些測試都是我們為公告機構或 FDA 收集和組織的。這不是一項小任務，對於記錄藥物和設備相互作用的安全性和可預測性至關重要。

Here's where ClearPoint Neuro has over a decade of experience gathering this data, refining our product and even adding to our portfolio and IP as you saw with our recent announcement of a cell therapy version of our delivery technology.

ClearPoint Neuro 擁有十多年收集這些數據、改進我們的產品、甚至添加到我們的產品組合和智慧財產權的經驗，正如您在我們最近宣布的細胞治療版本的輸送技術中所看到的那樣。

In the future, you will see ClearPoint Neuro with multiple routes of administration to diverse targets in the brain, spine and central nervous system, which will unlock new pharma partners that are prioritizing these alternative targets to the deep brain as we do today.

未來，您將看到 ClearPoint Neuro 對大腦、脊椎和中樞神經系統的不同目標提供多種給藥途徑，這將解鎖新的製藥合作夥伴，他們將像我們今天一樣優先考慮深部大腦的這些替代目標。

So why is ClearPoint investing so heavily into the biologics and drug delivery space. We believe our technology, our expanse in neurosurgery navigation and our significant head start puts us in a unique position that is worthy of maintaining and even expanding that lead.

那麼為什麼 ClearPoint 如此大力投資生物製劑和藥物傳遞領域？我們相信，我們的技術、我們在神經外科導航領域的廣泛應用以及我們顯著的領先優勢使我們處於獨特的地位，值得保持甚至擴大這一領先地位。

It is also very beneficial to have a more diverse customer base where we are not just depending on the hospitals themselves to purchase our products. We are often working with large and well-capitalized pharma companies that are already investing hundreds of millions into the space. Temporary downtrends in hospital procedures or capital spending can be offset by development and service revenue from pharma who value our head start and have access to capital even in a challenging environment.

擁有更多元化的客戶群也是非常有益的，這樣我們就不再只依賴醫院本身來購買我們的產品。我們經常與資本雄厚的大型製藥公司合作，這些公司已經在該領域投資了數億美元。醫院程序或資本支出的暫時下降趨勢可以被製藥公司的開發和服務收入所抵消，製藥公司重視我們的領先地位，即使在充滿挑戰的環境下也能獲得資本。

If we think about the true potential of this strategy, let's imagine that ClearPoint Neuro's existing partners, not new ones, but the 50 or so that we have today achieved commercial approval for their drug. That would be 50 different gene and cell therapy drugs available, treating more than 30 different neuro indications. Patients around the world would be speaking with neurologists who have been educated by their pharma sales reps about getting treated.

如果我們思考這項策略的真正潛力，讓我們想像一下 ClearPoint Neuro 的現有合作夥伴，不是新的合作夥伴，而是 50 個左右，我們今天已經獲得了他們的藥物的商業批准。這將是 50 種不同的基因和細胞治療藥物，可治療 30 多種不同的神經適應症。世界各地的患者將與接受過藥品銷售代表關於接受治療的教育的神經科醫生進行交談。

Now imagine that each of these drugs is co-labeled with 1 of our multiple different cannulas, so we have become an essential part of the pharma company supply chain. The very high switching costs necessary to move to a different delivery device because of the significant testing and clinical work necessary is a barrier for new entrants.

現在想像一下，這些藥物中的每一種都與我們多個不同插管中的一個共同標​​記，因此我們已成為製藥公司供應鏈的重要組成部分。由於需要大量的測試和臨床工作，轉向不同的輸送設備所需的轉換成本非常高，這對新進入者來說是一個障礙。

And because of this essential nature, we are able to not only protect pricing of our devices and navigation systems, but even expand commercial ASPs and which even at several times our current ASPs would be a fraction of the overall cost of the procedure. We would be in a position to earn not only milestones as already announced, but potentially also royalties, increased commercial device pricing and even package sales to pharma companies that want to kick the delivery device along with the drug itself and take the hospital out of the procurement equation for that procedure.

由於這種本質，我們不僅能夠保護我們的設備和導航系統的定價，甚至能夠擴大商業 ASP，甚至在我們目前的 ASP 的數倍下，它也只是整個過程成本的一小部分。我們不僅能夠獲得已經宣布的里程碑，而且還可能獲得特許權使用費、提高商業設備定價，甚至向那些希望將輸送設備與藥物本身一起踢掉並讓醫院擺脫困境的製藥公司打包銷售。該程序的採購方程式。

If this future is real, then every leading neurosurgery center will need a ClearPoint Neuro relationship and our installed base will further expand. We will grow roots and be an essential part of this new standard of care. We believe many hospitals will start working not only for commercialization, but for participation in the clinical trial work itself, which is why we feel confident in our ability to reach an installed base of 100 surgical sites by the end of 2025.

如果這個未來成為現實，那麼每個領先的神經外科中心都將需要 ClearPoint Neuro 關係，而我們的安裝基礎將進一步擴大。我們將紮根並成為這項新護理標準的重要組成部分。我們相信，許多醫院不僅會開始致力於商業化，還會開始參與臨床試驗工作本身，這就是為什麼我們對在 2025 年底達到 100 個手術站點安裝基地的能力充滿信心。

That is the rationale as to why we continue to invest in the space, which you saw in Q2 relative to R&D spending and a temporarily lower gross margin. On the R&D side, we have continued development not only for these new routes of administration, catheters, cannulas and needles as already discussed, but we have also continued development on new head frames like our Orchestra frame, new advanced drug delivery software to add to our Maestro platform and other technologies designed to make the procedures faster, simpler and more affectable like MRI conditional drills and dedicated infusion pump solutions.

這就是我們繼續投資該領域的理由，您在第二季度看到了相對於研發支出和暫時較低的毛利率的情況。在研發方面，我們不僅繼續開發已經討論過的這些新的給藥途徑、導管、插管和針頭，而且我們還繼續開發新的頭架，例如我們的Orchestra 框架、新的先進藥物輸送軟體，以添加到我們的 Maestro 平台和其他技術旨在使手術更快、更簡單、更有效，例如 MRI 條件鑽和專用輸液幫浦解決方案。

On the gross margin side, in an effort to build our presence and reputation in the preclinical space, we performed a projects at lower margins to show the value and responsiveness we bring to our partners. As we look ahead, we believe that this too has been the right investment and is giving us valuable experience as we jump start this exciting part of our business that leads directly to strategic partnerships mentioned before and is already yielding results.

在毛利率方面，為了努力建立我們在臨床前領域的影響力和聲譽，我們以較低的利潤開展了一個項目，以展示我們為合作夥伴帶來的價值和回應能力。展望未來，我們相信這也是正確的投資，並為我們提供了寶貴的經驗，因為我們快速啟動了業務中這一令人興奮的部分，直接導致了前面提到的戰略合作夥伴關係，並且已經產生了成果。

Now that was a lot of detail, but let's move on to our second growth pillar of functional neurosurgery navigation. This part of the business was relatively flat year-over-year as the growth we saw in deep brain stimulation navigation procedures was somewhat offset by the navigation of laser procedures, particularly laser ablation for epilepsy.

現在已經有很多細節了，但讓我們繼續討論功能神經外科導航的第二個增長支柱。這部分業務較去年同期相對持平，因為我們在深部腦部刺激導航手術中看到的成長在一定程度上被雷射手術導航（尤其是癲癇雷射消融手術）所抵消。

We have spoken about a high cancellation rate of procedures that increased during COVID due to illness, staff shortages and supply chain issues. It seems that the cancellation rate has come down for many of our navigation procedures, but it has remained elevated or even increased for these laser epilepsy procedures. This seems to be stemming from reimbursement denials for procedures in this half of the laser ablation market.

我們已經談到，在新冠疫情期間，由於疾病、人員短缺和供應鏈問題，手術取消率上升。我們的許多導航手術的取消率似乎有所下降，但雷射癲癇手術的取消率仍然很高，甚至增加。這似乎源自於雷射消融市場這一半市場的手術被拒絕報銷。

The appeal process is common and sometimes successful. However, the denial often takes place a couple of days before the surgery itself and it is often not possible to find another suitable patient to fill that scheduled MRI time. The result is that we missed out on the case for that day. This is something we're certainly paying attention to as we look to build our own laser business in the future. where it seems laser cancellations for tumor cases has not been nearly as common and the number of procedures continues to grow.

上訴程序很常見，有時甚至會成功。然而，拒絕通常發生在手術前幾天，而且通常不可能找到另一位合適的患者來填補預定的 MRI 時間。結果就是我們錯過了那天的案子。當我們希望未來建立自己的雷射業務時，這是我們肯定會關注的事情。似乎取消雷射治療腫瘤病例並沒有那麼常見，而且手術數量仍在持續增長。

The other delay on the neurosurgery part of the business is that 1 of our brain computer interface partners had to place our co-development programs on pause due to their internal constraints, which also negatively impacted revenue in the quarter and likely for at least the next couple of quarters, depending on the timing and availability of additional funds.

神經外科業務部分的另一個延遲是，我們的一個腦機介面合作夥伴由於其內部限製而不得不暫停我們的共同開發項目，這也對本季度的收入產生了負面影響，並且可能至少對下一個季度的收入產生負面影響。幾個季度，取決於額外資金的時間和可用性。

Similarly, our capital revenue for the quarter was down, which can happen from quarter-to-quarter based on timing and installation date. What I will mention of note is that we have launched a new capital subscription process as another tool for capital placement. This tool allows a hospital to sign up for a multiyear commitment that spreads the investment out over 5 years. The economics are very similar.

同樣，我們本季的資本收入也有所下降，根據時間和安裝日期，這種情況可能會逐季度發生。我要提到的是，我們啟動了新的資本認購流程，作為資本配置的另一個工具。該工具允許醫院簽署多年期承諾，將投資分攤到 5 年。經濟學非常相似。

However, there is a delay in revenue recognition in the first year as it acts as more of a service or rental agreement than a capital purchase, which would all be recognized day 1 of the placement. We have now had 5 hospitals sign up for the subscription service as part of our pilot, and we believe this will be a popular option in the years ahead. As a result, the capital line of our earnings will likely be flat or maybe decrease in the future where these subscriptions or rentals will increase the service line of the capital business.

然而，第一年的收入確認存在延遲，因為它更多地充當服務或租賃協議，而不是資本購買，而資本購買將全部在配售的第一天確認。作為試點的一部分，我們現在已經有 5 家醫院註冊了訂閱服務，我們相信這將在未來幾年成為一個受歡迎的選擇。因此，我們收益的資本線未來可能會持平或下降，而這些認購或租賃將增加資本業務的服務線。

On another positive note, we have had success on multiple new navigation technologies that we plan to submit to the FDA before the end of the year. These technologies will not only improve workflow for MRI procedures, but also represent our first navigation tool that is designed to be used start to finish in the operating room and not require the MRI at all.

另一個積極的方面是，我們在多項新的導航技術上取得了成功，我們計劃在今年年底前向 FDA 提交這些技術。這些技術不僅將改善 MRI 手術的工作流程，而且代表了我們的第一個導航工具，該工具旨在從頭到尾在手術室中使用，根本不需要 MRI。

As a reminder, more than 95% of all DBS and laser procedures are performed in the operating room and not the MRI suite today. This tool will allow us to compete where the vast majority of procedures are already taking place and not rely on moving users from the operating room into the MRI, which is often a completely new environment for the physician and for the hospital. We see this as a potential product transition to ClearPoint that can be fast and with fewer barriers because the more familiar workflow deployed today.

提醒一下，目前超過 95% 的 DBS 和雷射手術是在手術室而不是 MRI 套件中進行的。該工具將使我們能夠在絕大多數手術已經進行的地方進行競爭，而不是依賴將使用者從手術室轉移到 MRI，這對醫生和醫院來說通常是一個全新的環境。我們認為這是向 ClearPoint 的潛在產品過渡，由於今天部署了更熟悉的工作流程，因此可以快速且障礙更少。

For our third pillar of growth, therapy and access products, we have made progress with the new installs of PRISM as part of the limited market release for our first laser therapy system. We currently have 5 systems installed worldwide, and expect up to 5 more by the end of this year as part of the limited market release, where we test our system on multiple MRI scanners and software types as well as in multiple indications, including epilepsy and tumor.

對於我們的第三個支柱成長、治療和接觸產品，我們在新安裝 PRISM 方面取得了進展，作為我們首個雷射治療系統有限市場發布的一部分。目前，我們在全球安裝了5 個系統，預計到今年年底還會安裝多達5 個系統，作為有限市場發布的一部分，我們在多種MRI 掃描儀和軟體類型以及多種適應症上測試我們的系統，包括癲癇和瘤。

These cases give us experience and help us build educational materials for a broader launch in 2024. We have identified and began the training of our dedicated clinical specialist team, which will be able to support complete laser cases, including both navigation and therapy by the end of this year. While we are very early in the limited release, we are pleased with the ease of use and the capability of our system.

這些案例為我們提供了經驗，並幫助我們為2024 年更廣泛的推出製作教育材料。我們已經確定並開始培訓我們的專門臨床專家團隊，該團隊將能夠支援完整的雷射案例，包括到年底的導航和治療今年的。雖然我們還處於有限發布的早期階段，但我們對系統的易用性和功能感到滿意。

Of all the installations performed to date, the clinician feedback has been very encouraging, and we expect higher utilization of the system in the future. Laser ablation for neuro applications represents an approximately $30 million market today. The PRISM product combined with the capability of our team and our platform should give us a competitive advantage and we have multiple applications supported, including deep brain stimulation, biopsy, laser ablation, brain computer interface and biologics and drug delivery.

在迄今為止執行的所有安裝中，臨床醫生的回饋非常令人鼓舞，我們預計未來系統的使用率會更高。目前，用於神經應用的雷射燒蝕市場價值約為 3000 萬美元。 PRISM 產品與我們團隊和平台的能力相結合，應該會給我們帶來競爭優勢，並且我們支援多種應用，包括深部腦部刺激、活檢、雷射消融、腦機介面以及生物製劑和藥物傳輸。

The exciting part of these first 3 pillars is that we plan for each pillar to be a growth driver in the next 2 to 3 years. Biologics and drug delivery will drive most of the growth in '23 and '24 and neuro navigation, especially in the operating room as well as laser therapy will contribute more substantially in 2024 and 2025. If all 3 of these pillars achieve our development milestones and modest expectations for market growth, we expect to exit Q4 of 2025 at operational cash flow breakeven, which again would represent about 50 hospitals doing 50 cases a year plus the contribution of our biologics and drug delivery services.

前三個支柱中令人興奮的部分是，我們計劃每個支柱都成為未來 2 到 3 年的成長動力。生物製劑和藥物傳輸將推動「23」和「24」的大部分成長，神經導航（尤其是手術室）以及雷射治療將在2024 年和2025 年做出更大貢獻。如果這三個支柱全部實現我們的發展里程碑，由於對市場成長的預期不高，我們預計到2025 年第四季將實現營運現金流盈虧平衡，這同樣意味著大約50 家醫院每年處理50 個病例，加上我們的生物製劑和藥物輸送服務的貢獻。

This really represents pillar #4 of achieving global scale and profitability, which is something we think about frequently and prioritize. While we do have $26.5 million in cash available, we want to make sure that we hit that inflection point and move toward profitability. As mentioned earlier, we have made substantial investments in our quality system, regulatory capabilities and our operations, including a new manufacturing facility in Carlsbad, California.

這確實代表了實現全球規模和獲利能力的第四支柱，這是我們經常考慮和優先考慮的事情。雖然我們確實有 2650 萬美元的可用現金，但我們希望確保我們能夠達到這個拐點並實現盈利。如前所述，我們在品質系統、監管能力和營運方面進行了大量投資，包括在加州卡爾斯巴德建立新的製造工廠。

This investment was for a clear purpose as well, ensuring that all of our sophisticated pharma companies see us as a reliable partner and supplier. With more than 50 active pharma partnerships, you must understand that we are audited by these companies on a monthly, if not weekly basis. Having a strong team and manufacturing facility in place to pass these audits with flying colors is another advantage we have when working with the pharmaceutical industry that can separate us from the competition.

這項投資也有明確的目的，確保我們所有成熟的製藥公司將我們視為可靠的合作夥伴和供應商。我們擁有 50 多家活躍的製藥合作夥伴，您必須了解這些公司每月（甚至每週）都會對我們進行審核。擁有強大的團隊和製造設施來出色地通過這些審核是我們與製藥業合作時的另一個優勢，可以使我們在競爭中脫穎而出。

Similarly, we've expanded our global regulatory footprint to include multiple countries beyond only the United States and the European Union. The investment is real, but it is also a powerful tool with pharma customers when they see this capability to expand to broader and sometimes underserved market, it is 1 more reason to choose the ClearPoint offering.

同樣，我們也擴大了全球監管範圍，將美國和歐盟以外的多個國家納入其中。這項投資是真實的，但對於製藥客戶來說，它也是一個強大的工具，當他們看到這種能力可以擴展到更廣泛且有時服務不足的市場時，這是選擇ClearPoint 產品的另一個理由。

I'm happy to report that Carlsbad facility is ahead of schedule, and we actually completed construction of the new clean room here in the second quarter. We believe that we will be able to produce sellable and inspected product by the end of this year and winds down our redundant operations in Irvine, California by the end of 2023.

我很高興地向大家報告，卡爾斯巴德工廠的進度提前了，我們實際上在第二季完成了新無塵室的建設。我們相信，我們將能夠在今年年底前生產可銷售且經過檢驗的產品，並在 2023 年底前結束我們在加州歐文市的冗餘業務。

As seen in 2022, based on the timing of some larger cash events, we expect the operational cash burn in the second half of 2023 to be lower than in the first half.

從 2022 年來看，根據一些較大現金事件的時間安排，我們預計 2023 年下半年的營運現金消耗將低於上半年。

While our margin dipped down in Q2, we do not expect this to be a long-term issue but more of a reflection that we are currently launching new products and services in biologics and drug delivery, laser therapy, access devices and operating room navigation. All new product introductions have some level of ramp-up efforts at launch that take some time to scale. We believe we have a portfolio of products that can achieve 70% plus gross margin in aggregate in the years ahead, especially when the growth of products once again overtakes services with all of these new product introductions.

雖然我們的利潤率在第二季度下降，但我們預計這不會是一個長期問題，而更多地反映出我們目前正在生物製品和藥物傳輸、雷射治療、接入設備和手術室導航領域推出新產品和服務。所有新產品的推出都會在發佈時進行一定程度的提升工作，需要一段時間才能擴大規模。我們相信，我們的產品組合在未來幾年可以實現 70% 以上的毛利率，特別是當產品的成長再次超過服務的成長時，所有這些新產品的推出。

We continue to see an exciting opportunity in front of us and have worked incredibly hard getting all the puzzle pieces in place over the past couple of years. Now our focus is putting our existing strategy and resources to work to gain scale and leverage. As mentioned, we have $26.5 million in cash at the end of the quarter and expect our operating burn to meaningfully decrease in the second half of this year as the vast majority of our head count is already in place and we will wrap up the transition to our new manufacturing facility.

我們繼續看到擺在我們面前的令人興奮的機會，並在過去幾年中付出了難以置信的努力，將所有拼圖拼湊到位。現在我們的重點是運用現有的策略和資源來擴大規模和發揮影響力。如前所述，我們在本季末擁有 2,650 萬美元的現金，預計我們的營運消耗將在今年下半年大幅減少，因為我們的絕大多數員工已經就位，我們將完成向我們的新製造工廠。

We remain focused on executing our key value-creating milestones over the next 6 to 12 months, including new strategic biologic partnerships, initiation of new drug clinical trials, submission of the first BLA using ClearPoint technology to the FDA for commercial approval, expansion into the operating room and exiting the limited market release for our PRISM laser therapy system. And that's a lot to digest. So let's take a break and open up the floor to any questions.

我們將繼續專注於在未來6 至12 個月內執行我們的關鍵價值創造里程碑，包括新的策略性生物合作夥伴關係、啟動新藥臨床試驗、向FDA 提交第一個使用ClearPoint 技術的BLA 以獲得商業批准、擴展到手術室並退出我們的 PRISM 雷射治療系統的有限市場發布。這需要消化很多。那麼，讓我們休息一下，歡迎大家提出任何問題。

(Operator Instructions) And our first question comes from Frank Takkinen from Lake Street Capital.

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

This is Nelson Cox on the phone for Frank today. It sounds like growth in OpEx during the quarter was mostly related to the new facility, and it should be lower in the second half of the year. Just trying to think about how OpEx should be moving forward? Is that something that we should look at Q1 for more of a baseline moving forward? Or how should we think about that?

我是納爾遜·考克斯，今天打電話給弗蘭克。聽起來本季營運支出的成長主要與新設施有關，下半年應該會有所下降。只是想想營運支出該如何向前發展？我們是否應該關注第一季的情況，以作為未來發展的更多基準？或者說我們該如何思考這個問題？

Well, I would think -- Nelson, I think it a little bit differently in that, as I mentioned, the biggest part of our OpEx is really labor and personnel. We're up to about 115 employees, I think, worldwide. And that's the number that we sit here in Q2 that fell into the operating expense line plus some into the cost of goods, obviously, what I would expect is that overall headcount number to remain relatively flat as again, a lot of the hiring we've done for these biologic services as well as preparation for the launch of products on the commercial side. The hiring has already taken place. The training has begun, and we don't really need to hire many additional people.

嗯，我想 - 尼爾森，我認為有點不同，正如我所提到的，我們營運支出的最大部分實際上是勞動力和人員。我想，我們在全球大約有 115 名員工。這就是我們在第二季度的數字，該數字屬於營運費用線，加上一些商品成本，顯然，我預計總體員工人數將再次保持相對平穩，我們的大量招聘我們為這些生物服務以及商業方面的產品上市做了準備。招聘工作已經進行。訓練已經開始了，我們真的不需要再僱用很多人了。

So the biggest driver of OpEx should not be changing that much. What can change quarter-to-quarter is some things we do with partnerships, whether it's co-development work, whether it's licensing the technology, things like that.

因此，營運支出的最大推動力應該不會發生太大變化。每個季度都會發生變化的是我們與合作夥伴所做的一些事情，無論是共同開發工作，無論是技術許可，諸如此類。

So that can be a little bit choppy, but the primary driver should be remaining relatively flat with just some inflationary adjustments over the next 6 to 12 months. Hopefully, that helps.

因此，這可能會有點波動，但主要驅動力應該保持相對平穩，在未來 6 到 12 個月內僅進行一些通膨調整。希望這會有所幫助。

Got it. Yes. And then in the past, you've talked about total partnership revenue potentially being up to $10 million prior to commercial approval with milestones included in the recent UCB partnership? And could this be a particular partnership have revenue potential in excess of $10 million. And that going forward, I think you've talked about it being a blueprint. It sounds like we should -- is that something we should expect being a standard feature moving forward?

知道了。是的。然後在過去，您曾談到在商業批准之前合作夥伴總收入可能高達 1000 萬美元，其中包括最近的 UCB 合作夥伴關係中的里程碑？這可能是一個具有超過 1000 萬美元收入潛力的特殊合作夥伴關係。展望未來，我想你已經談到了它是一個藍圖。聽起來我們應該——這是我們應該期望成為未來標準功能的東西嗎？

Yes. I would say UCB is 1 example of the multiple deals that we have either signed that are in term sheet status or are actively being negotiated right now.

是的。我想說，UCB 是我們已簽署的多項交易的一個例子，這些交易要么處於條款清單狀態，要么目前正在積極談判。

It just happens to be one of the ones that we announced. But from that standpoint, yes, these are the large incidence type of relationships and target drug markets that require not just quite a bit of preclinical and clinical work, but the clinical trials themselves sometimes can be upwards of 100 or 200 or even more patients. So selling products into the clinical trial prior to the commercial approval is certainly something that drives that.

它恰好是我們宣布的其中之一。但從這個角度來看，是的，這些關係和目標藥物市場的發生率很高，不僅需要大量的臨床前和臨床工作，而且臨床試驗本身有時可能需要 100 或 200 名甚至更多的患者。因此，在獲得商業批准之前將產品銷售到臨床試驗無疑是推動這一趨勢的因素。

And the larger the incidence level as well as the larger the number of alternative treatments that are available, the more detailed the FDA is going to be -- is going to require to go ahead and improve the efficacy of the drug as well as the economics of the drug itself. So -- so again, UCB is an example, but we've got multiple other programs in the works that could potentially exceed that $10 million number if all of the milestones as well as the trial revenue is successful.

發病率越高，可用的替代療法數量越多，FDA 就會要求越詳細，以提高藥物的功效和經濟效益。藥物本身。所以，UCB 就是一個例子，但我們還有多個其他項目正在進行中，如果所有里程碑以及試驗收入都取得成功，這些項目的金額可能會超過 1000 萬美元。

Got it. And then 1 more quick one, if I can. Is there -- do you see any opportunities to restructure some previous partnerships to include that driven milestone payment structure?

知道了。如果可以的話，然後再快一點。您是否認為有機會重組之前的一些合作夥伴關係，以包括驅動的里程碑付款結構？

I think absolutely. In fact, as we have continued to add biologic services, there's a larger part of the menu that we can offer and many of our existing partners are kind of stage things. As a reminder, 1 level of a partnership could simply just be some initial benchtop testing followed by some consulting services, consulting hours and things like that. So year 1 might only be $20,000, $30,000, give or take.

我認為絕對是。事實上，隨著我們不斷增加生物服務，我們可以提供的菜單的很大一部分，而我們現有的許多合作夥伴都處於階段性的階段。提醒一下，一級合作關係可能只是一些初步的桌上型測試，然後是一些諮詢服務、諮詢時間等。因此，第一年可能只有 20,000 美元、30,000 美元，或多或少。

Where that changes is once they're happy with our product and they recognize that we're very likely going to be a part of their drug label, these companies also realize that our experience is valuable, our head start is valuable and that they're going to be working with us for years, if not decades.

一旦他們對我們的產品感到滿意並且他們認識到我們很可能成為他們藥品標籤的一部分，這些公司也會意識到我們的經驗是有價值的，我們的領先優勢是有價值的，並且他們會意識到我們的經驗是有價值的，我們的領先優勢是有價值的我們將與我們合作數年，甚至數十年。

And they want some assurances that we are going to be around and supporting them in the future. So it's normally year 1 or year 2 into a relationship where we begin talking through these much more sophisticated and strategic agreements, which can include backup manufacturing.

他們希望得到一些保證，確保我們將來會在他們身邊並支持他們。因此，通常在建立關係的第一年或第二年，我們開始討論這些更複雜的策略協議，其中可能包括備用製造。

They can include access to IP, they can include a lot of different things. So that a pharma company can ensure control and access to this important part of their supply chain. So it's -- I would say it's more common than not. -- that we might have a partner today that will eventually turn into a more sophisticated agreement. That's also a common point where we would negotiate commercial terms of the device itself, which in many cases, can be multiples of the existing sort of break we give in pricing during the development process for the disposable products.

它們可以包括對IP的訪問，可以包括很多不同的東西。這樣製藥公司就可以確保對其供應鏈這一重要部分的控制和存取。所以我想說這比不常見更常見。 ——我們今天可能有一個合作夥伴，最終會變成一個更複雜的協議。這也是我們協商設備本身商業條款的一個共同點，在許多情況下，這些條款可能是我們在一次性產品開發過程中給予定價的現有突破的倍數。

So I'd say much -- many more of those 50 partners, we still have the opportunity to continue negotiating as they get closer to initiating their clinical trial.

所以我想說很多——這 50 個合作夥伴中的更多合作夥伴，隨著他們越來越接近啟動臨床試驗，我們仍然有機會繼續談判。

(Operator Instructions) our next question comes from Neil Chatterji from B. Riley.

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

This is William Wood on for Neil. Really appreciate everything that you've done, it's looking good. I'm not sure -- just to start off, a quick question on your gross margins. I know you said those were primarily focused on or as a result of your Carlsbad facility as well as preclinical services sort of being a larger part of that.

我是尼爾的威廉‧伍德。真的很感謝你所做的一切，看起來不錯。我不確定——首先，簡單問一下你們的毛利率。我知道您說過這些主要集中於您的卡爾斯巴德設施，或者是其結果，以及臨床前服務是其中的很大一部分。

With the Carlsbad facility coming to an end by year-end. How should we think about -- I know you said gross margin should reach into the 70s in the coming years, but maybe give us a little bit more color on how we should be thinking about those for 2023, maybe even 2024. Is preclinical going to be a continued large contributor? And then obviously, Carlsbad will sort of fade off. Just a little bit more color would be appreciated.

卡爾斯巴德工廠將於年底竣工。我們該如何思考——我知道你說過未來幾年毛利率應該達到 70 多歲，但也許讓我們更了解我們應該如何思考 2023 年，甚至 2024 年的毛利率。臨床前進展是否順利成為持續的大貢獻者？顯然，卡爾斯巴德將會逐漸消失。只要多一點顏色就會受到讚賞。

Yes, the 2 primary drivers, as you pointed out, for the kind of the reduced gross margin in the quarter. And to frame it appropriately as well. If you look back at our history, quarter-to-quarter, based on what revenue gets recognized, the gross margin can actually jump around quite a bit.

是的，正如您所指出的，本季毛利率下降的兩個主要驅動因素。並適當地建構它。如果你回顧我們每季的歷史，根據確認的收入，毛利率實際上可能會大幅上漲。

But if we look specifically at the second quarter, there were 2 primary drivers. One is the redundant space and facility that we have relative to our prior Irvine facility and the new Carlsbad facility. So bringing Carlsbad up, having some certain construction but also having redundancy and travel between the sites and things like that, while making the same number of products that is obviously to impact gross margins, and we certainly saw that in the quarter.

但如果我們具體觀察第二季度，就會發現有兩個主要驅動因素。一是與之前的爾灣工廠和新的卡爾斯巴德工廠相比，我們擁有多餘的空間和設施。因此，讓卡爾斯巴德崛起，進行一些特定的建設，但也有冗餘和站點之間的旅行等類似的事情，同時生產相同數量的產品，這顯然會影響毛利率，我們在本季度肯定看到了這一點。

The second thing, which is also, we believe, somewhat temporary is that when you launch a new product, we're kind of the new kids on the block, and we want to go ahead and demonstrate our services and prove our capabilities. And in a couple of instances in the quarter, we ran some studies and did some testing for really mega cap pharma companies, to get our foot in the door. And I would say that strategy worked. However, giving a discount on that study kind of brought some of the gross margin down as well.

我們認為，第二件事也是暫時的，當你推出新產品時，我們就像是新來的孩子，我們希望繼續展示我們的服務並證明我們的能力。在本季度的幾個例子中，我們對真正的大型製藥公司進行了一些研究和測試，以邁出第一步。我想說這個策略奏效了。然而，對該研究給予折扣也導致了部分毛利率的下降。

So what I would say is that the 53% you saw in Q2, we're definitely not going to switch and be at that 70% mark. But 53% is probably the lowest that we would expect. And as Carlsbad is fully up and running and Irvine kind of shuts down by the end of this year, that's when we'd start seeing a kind of a broad improvement as well.

所以我想說的是，你在第二季度看到的 53%，我們絕對不會改變並保持在 70% 的水平。但 53% 可能是我們預期的最低值。隨著卡爾斯巴德全面啟動並運行，而爾灣將在今年年底關閉，那時我們也將開始看到廣泛的改善。

But to answer your other question, we do absolutely expect continued growth of services -- so that gross margin of the services is going to continue to be a significant factor. And while that margin is not going to be as high as typical product disposable revenues, which we've seen in the 70% before, it's also not going to be as low as it was necessarily in Q2. So it will be a much more positive contributor to our margin moving forward.

但要回答你的另一個問題，我們絕對預計服務將持續成長，因此服務的毛利率將繼續成為一個重要因素。雖然這一利潤率不會像我們之前看到的 70% 那麼高，但也不會像第二季那麼低。因此，這將對我們未來的利潤做出更積極的貢獻。

Got it. That's very helpful. Additionally -- and correct me if I'm wrong or maybe even fill in the gap, you had mentioned that you were going to be potentially moving into a tumor -- laser business in tumor sort of -- it sounded like you were going to really sort of take on that. I guess if you could just sort of flesh that out for me on how much of a tumor industry you plan to incorporate into your business strategy?

知道了。這非常有幫助。另外——如果我錯了或可能填補空白，請糾正我，你曾提到你將有可能進入腫瘤領域——腫瘤領域的雷射業務——聽起來你打算確實有點接受這一點。我想您是否可以向我具體說明您計劃將多少腫瘤行業納入您的業務策略？

Yes, I think it's going to be a significant focus for us in a number of different ways. The first comment I would make is that if you look at the hospitals that ClearPoint has a presence in today, primary user of our technology is someone called a functional neurosurgeon. And this is someone that would treat something like essential tremor or Parkinson's disease or epilepsy or things like that. This is commonly where deep brain stimulation is used. But it's also where laser is a common treatment for epilepsy.

是的，我認為這將在許多方面成為我們關注的重點。我要說的第一條評論是，如果你看看 ClearPoint 目前所在的醫院，你會發現我們技術的主要使用者是被稱為功能性神經外科醫生的人。這個人可以治療特發性震顫、帕金森氏症、癲癇或類似疾病。這通常是使用深度腦刺激的地方。但這也是雷射治療癲癇的常用方法。

So if you think about where our strength and most of our relationships are today, it's primarily on the functional neuro side of the business, which is also laser for epilepsy. What's a truly untapped potential for us is the neuro-oncology side of the business, which is generally a different neurosurgeon and a different customer that historically, we've had very little experience with. We have probably 5 or so sites that are routinely using us for oncology purposes today.

因此，如果你想想我們今天的優勢和大部分關係在哪裡，你會發現它主要集中在業務的功能性神經方面，這也是治療癲癇的雷射。對我們來說，真正尚未開發的潛力是業務的神經腫瘤學方面，這通常是不同的神經外科醫生和不同的客戶，而我們在歷史上幾乎沒有與之接觸過的經驗。目前，我們大約有 5 個左右的站點經常使用我們的腫瘤學目的。

So I think the launch of a new laser that's designed and software that's designed specifically for tumor applications is going to be a way to be introduced into that tumor market. And then similarly, we have a number of drug partners that are also interested in doing work for tumors, not treating epilepsy or Huntington's or Parkinson's or things like that.

因此，我認為推出專為腫瘤應用設計的新型雷射和軟體將成為進入該腫瘤市場的一種方式。同樣，我們有許多藥物合作夥伴也有興趣從事腫瘤研究，而不是治療癲癇、亨廷頓舞蹈症、帕金森氏舞蹈症或類似疾病。

So as some of those partners move into the clinical trial stage, we have an opportunity to work with those hospitals on either laser therapy or drug delivery or what I think is actually going to be somewhat common is what I'd call a hybrid therapy where the procedure starts with an ablation.

因此，隨著其中一些合作夥伴進入臨床試驗階段，我們有機會與這些醫院合作進行雷射治療或藥物輸送，或者我認為實際上會比較常見的是我所說的混合療法，其中該手術從消融開始。

And then a drug is introduced into the margin to kind of clean up the part that was maybe missed by the ablation itself. So you're absolutely right. Part of the investment that we are making is to go into oncology with a commercial team now that we've got products and pharma partnerships that can kind of carry some of that burden with us.

然後將藥物引入邊緣，以清理可能因消融本身而遺漏的部分。所以你是完全正確的。我們正在進行的投資的一部分是與商業團隊一起進入腫瘤學領域，因為我們已經擁有了產品和製藥合作夥伴關係，可以為我們承擔一些負擔。

Thanks, Burnett. That sounds really good, actually. And then additionally, you've mentioned some of your milestone deals are at least sort of hinted to them. Can you talk to your ambition about really trying to incorporate these milestone deals where you have a tie to the drug itself and how you think these will be advancing going into second half and then later on in development? Is this really going to be a top priority? Or just any extra -- any details would be appreciated.

謝謝，伯內特。事實上，這聽起來確實不錯。另外，您也提到您的一些里程碑交易至少向他們有所暗示。您能否談談您的雄心壯志，即真正嘗試將這些與藥物本身有聯繫的里程碑交易納入其中，以及您認為這些交易將如何推進到下半年以及稍後的開發中？這真的會成為首要任務嗎？或者只是任何額外的——任何細節將不勝感激。

Yes, is the way I think of it as this is for the -- I don't want to say the first time ever, but first time in sort of recent memory, we have a number of different pharmaceutical companies that are now going to be dependent on a device of some kind to get their drug to the target. So the decision that they need to make is to say, look, do we build our own R&D team that's really a device company and we set up our own device quality system and complaint handling and supply chain, all of these different things, is that an investment as a pharma company that we want to build up from scratch, or we just partner with a company like ClearPoint that effectively can give them that black box solution of a quality system, complaint handling, neuroscientist specialist team that's in the field to help deliver the drug.

是的，這是我的想法，因為這是——我不想說這是第一次，但在最近的記憶中，這是第一次，我們有許多不同的製藥公司現在要依賴某種裝置將藥物輸送至目標。因此，他們需要做出的決定是，看，我們是否建立自己的研發團隊，這實際上是一家設備公司，我們建立自己的設備品質系統、投訴處理和供應鏈，所有這些不同的事情都是作為一家製藥公司的投資，我們希望從頭開始建立，或者我們只是與像ClearPoint 這樣的公司合作，該公司可以有效地為他們提供品質系統、投訴處理、神經科學家專家團隊的黑盒解決方案，該團隊在該領域提供幫助交付藥物。

We're really building ourselves into that turnkey solution, and that turnkey solution is what we feel earns us a seat at the table as it relates to getting a piece of the success of the drug itself. It's really risk-sharing agreement and the bigger part that we play in the development cycle of the drug, the more that we should benefit from some of that risk as well.

我們確實正在將自己打造為交鑰匙解決方案，而我們認為交鑰匙解決方案為我們贏得了一席之地，因為它關係到從藥物本身的成功中分得一杯羹。這確實是風險分擔協議，我們在藥物開發週期中發揮的作用越大，我們也應該從其中的一些風險中受益越多。

So I think what you'll see in the future, our expectation is there's going to be a bunch of different flavors. Some might be heavily weighted towards milestones. Some might be heavily weighted towards commercial pricing of the product of our devices. Some might be weighted towards royalties on the drug itself. There might be 3 or 4 different players, but the concept will all be the same is that we want a long-term relationship with pharma, and pharma wants a long-term relationship with us. And we feel like we are one of the best value way to do it compared to trying to build it yourself.

所以我認為你將來會看到什麼，我們的期望是會有很多不同的口味。有些可能會非常重視里程碑。有些可能會嚴重關注我們設備產品的商業定價。有些可能會偏重於藥物本身的特許權使用費。可能有 3 到 4 個不同的參與者，但概念都是一樣的，那就是我們希望與製藥公司建立長期合作關係，而製藥公司希望與我們建立長期合作關係。我們覺得，與嘗試自己建造相比，我們是最有價值的方式之一。

That makes sense. And just a quick follow-up. I know you've mentioned or sometimes it's been a bit of an illusion or we can't -- we don't quite get all the details on these partnerships, the milestones, et cetera. And sometimes even who your partners are, do you think you'll be giving or providing more color going forward, just so we have a better idea of where to be looking, as you mentioned, Aspen this morning or Aspen, sorry, this morning or just now, we'll be -- well, will we be getting better color in the future? Just curious.

這就說得通了。只是快速跟進。我知道你提到過，有時這有點幻覺，或者我們不能——我們不太了解這些合作夥伴關係、里程碑等的所有細節。有時，即使你的合作夥伴是誰，你認為你會在未來給予或提供更多的色彩，這樣我們就可以更好地了解去哪裡尋找，正如你提到的，今天早上阿斯彭還是阿斯彭，對不起，今天早上或現在，我們會——嗯，我們將來會得到更好的顏色嗎？只是好奇。

Yes. I mean I think that we don't necessarily do it by choice -- if I wanted to or if I could, I would simply announce all the partners. But I think what we try to do is, most importantly, be a good and loyal partner to these people we're working with in the pharma industry. And if they ask us to keep it secret up until a certain point, we're happy to oblige by that. I think the 2x that you've seen us really announce these types of partnerships in the past, which I would expect to continue in the future is, one, maybe where we do a multi-platform type deal like we announced with UCB. That could be 1 trigger, if you will, for an announcement.

是的。我的意思是，我認為我們不一定會選擇這樣做——如果我願意或可以的話，我會簡單地宣布所有合作夥伴。但我認為，最重要的是，我們要做的是成為製藥業中與我們合作的人們的良好而忠誠的合作夥伴。如果他們要求我們在某種程度上保守秘密，我們很樂意遵守。我認為您在過去看到的兩次我們確實宣布了這些類型的合作夥伴關係，我希望這種合作關係在未來繼續下去，其中之一，也許我們會進行多平台類型的交易，就像我們與UCB 宣布的那樣。如果你願意的話，這可能是發佈公告的 1 個觸發器。

The second one could be the announcement of an IDE or a first patient enrolled in a trial. It's very common that you would see a press release from us that says, "Hey, congratulations, happy to be a part of this." Those are kind of the 2 key milestones that we've seen in the past. But at the end of the day, we want to be good partners and we let the pharma company decide when is the right time for them to announce it.

第二個可能是宣布 IDE 或第一位患者參加試驗。您經常會看到我們的新聞稿說：“嘿，恭喜，很高興成為其中的一部分。”這些是我們過去看到的兩個關鍵里程碑。但歸根結底，我們希望成為良好的合作夥伴，我們讓製藥公司決定何時是他們宣布這一消息的合適時機。

I can tell you, in some cases, especially with some of the smaller pharma and biotech companies, the fact that they're able to announce that they're working with ClearPoint, actually can benefit them from a fundraising standpoint or from an awareness standpoint or even when they're recruiting centers or sites for their clinical trial, which often starts way before the first patient is enrolled. Having the ClearPoint name attached to them, we believe is a benefit to their brand and their trial as well. So it's possible that, that could be accelerated, but it's probably not going to be something that we drive.

我可以告訴您，在某些情況下，尤其是一些規模較小的製藥和生物技術公司，他們能夠宣布與 ClearPoint 合作，實際上可以從籌款的角度或從意識的角度使他們受益甚至當他們正在招募臨床試驗中心或地點時，這通常在第一個患者入組之前就開始了。我們相信，將 ClearPoint 名稱附加到他們身上，對他們的品牌和試用都有好處。因此，這可能會加速，但它可能不會成為我們推動的事情。

Great -- all makes sense. And then -- with your lasers, you -- I know it's a limited launch, but -- and you mentioned that you already installed 5 worldwide and expect 5 more. I'm just curious, should we -- is this -- once you do a full -- like what would be the maybe year-over-year growth? Or what would be the growth rate? Or what type of installation do you think we could be expecting once you had a full release? Or is it just too early to sort of tell?

太棒了——一切都有道理。然後--用你的雷射器，你--我知道這是一次有限的發射，但是--你提到你已經在全球範圍內安裝了 5 個，並預計還會安裝 5 個。我只是好奇，我們是否應該——是這樣——一旦你做了一個完整的——就像可能的同比增長是多少？或成長率是多少？或者，您認為一旦您發布了完整版本，我們會期待什麼類型的安裝？還是現在判斷還太早？

Yes. I mean, I don't know we want to give too many details. What I would tell you, just to set expectations is that getting an installation is not a simple process. There's really 3 things to consider that are barriers that need to be overcome. And it's really why there's only a couple of companies in this space. They've done a lot of hard work to build the market to where it is, but it has not been easy.

是的。我的意思是，我不知道我們想要提供太多細節。我要告訴你的是，只是為了設定期望，安裝並不是一個簡單的過程。實際上有 3 件事需要考慮，這些都是需要克服的障礙。這就是為什麼這個領域只有幾家公司的原因。為了將市場建立到目前的水平，他們做了很多艱苦的工作，但這並不容易。

The first is that you need to have and be able to show compatibility on all of the different systems. So you have to get FDA clearance for all of the different systems. If you look at our approval today with CLS, we actually only have approval for 3 Tesla scanners that are manufactured by Siemens and by GE.

首先，您需要具有並能夠在所有不同的系統上表現出相容性。因此，所有不同系統都必須獲得 FDA 許可。如果你看看我們今天與 CLS 的批准，我們實際上只批准了由西門子和 GE 製造的 3 台 Tesla 掃描儀。

So we really only have access to part of the known universe, and we have to continue with some more testing and another FDA submission before we can add Philips or before we can add 1.5 Tesla to the equation. So that's one sort of thing that rate limits [how quickly] we go.

因此，我們實際上只能接觸到已知宇宙的一部分，並且在添加飛利浦或將 1.5 特斯拉添加到方程式之前，我們必須繼續進行更多測試並提交另一項 FDA 申請。所以這是一種限制我們前進速度的因素。

The second one is that, as we shared with our navigation software as well, getting any new piece of hardware or software into a hospital is so much harder than it's ever been in my career, specifically from an IT standpoint, the level of testing and questionnaires to ensure there's no cyber-criminal activity or you're introducing anything to a hospital. The hoops you have to jump through are so significantly more severe than they've ever been, that any new capital equipment is hard and laser fits into that as well.

第二個問題是，正如我們在導航軟體中所分享的那樣，將任何新的硬體或軟體引入醫院比我職業生涯中的任何時候都要困難得多，特別是從IT 的角度來看，測試和測試的水平調查問卷以確保不存在網路犯罪活動或您向醫院介紹任何東西。你必須跨越的障礙比以往任何時候都更加嚴峻，任何新的資本設備都很難，而雷射也適合這一點。

And then the third part is that there's quite a bit of testing that actually has to go into install. So let's say we have a hospital that has approved the evaluation or the purchase or the subscription they're ready to go. We need to get about a couple of days of MRI time to do the specific testing for that hospital scanner and make sure we operate with their protocols and everything else. And just getting that scanner time sometimes can be slow going as well.

第三部分是安裝時需要進行大量測試。假設我們有一家醫院已經批准了評估或購買或訂閱，他們已經準備好了。我們需要大約幾天的核磁共振時間來對醫院掃描儀進行具體測試，並確保我們按照他們的協議和其他一切進行操作。有時僅僅獲得掃描器時間也會很慢。

So I think I said in the prepared remarks that in the second half of this year, we can install up to 5 more systems as part of the limited market release. By definition, I would say the LMR is meant to be slower than a full market release.

所以我想我在準備好的發言中說過，今年下半年，我們可以再安裝最多 5 個系統，作為有限市場發布的一部分。根據定義，我想說 LMR 的速度比完整的市場發布要慢。

But there's a certain governor on how fast we can even go during the SMR. So it's not going to be a flip of a switch, and we have a massive installed base. I think where our focus is going to be is getting installed in hospitals that have significant volume where we can compete for that volume that's already there. I think that's going to be a bigger part of our story versus growing the market, which is going to take a bit more time.

但在 SMR 期間我們能走多快有一個特定的規定。因此，這不會是一個簡單的開關，而且我們擁有龐大的安裝基礎。我認為我們的重點是在擁有大量容量的醫院中安裝，我們可以與現有的容量進行競爭。我認為這將成為我們故事中更重要的部分，而不是發展市場，這將需要更多的時間。

That makes sense. I appreciate that. And then last question. You gave some updates last time and hear now about your -- the recent regulatory pathway, setting up sites in the EU and then most recently, in Brazil, just -- I believe you may be mentioned China in the past also. Just curious where we might be, if there's any additional countries that you're sort of currently in the works and where -- when we might expect to see some of these additional operational areas come online?

這就說得通了。我很感激。然後是最後一個問題。您上次提供了一些最新情況，現在了解您的 - 最近的監管途徑，在歐盟設立站點，然後最近在巴西，只是 - 我相信您過去也可能提到過中國。只是好奇我們可能會在哪裡，是否有任何其他國家/地區目前正在進行工作，以及我們何時可能期望看到其中一些額外的營運區域上線？

Yes. There's probably a few like -- one of the key first step was the MDSAP certification that our quality system received last year, that opens the door for a -- from a quality system standpoint into a number of countries, including I think Canada, Japan, Australia, Brazil, a few other ones that are included in that consortium.

是的。可能有一些類似的——關鍵的第一步是我們的品質系統去年獲得的 MDSAP 認證，這為——從品質系統的角度進入許多國家打開了大門，我認為包括加拿大、日本、澳洲、巴西以及該聯盟中的其他一些國家。

So that's 1 place where I think you could look to that you should expect sometime in the next couple of years that we'll be expanding or at least starting the regulatory process. The priority, I would say we have outside of the U.S. and the EU is again based on our pharmaceutical partners.

因此，我認為您可以關注這一點，您應該期望在未來幾年的某個時候我們將擴大或至少啟動監管流程。我想說，我們在美國和歐盟以外的優先事項再次基於我們的製藥合作夥伴。

So we might have a pharma partner that is based in 1 particular country in Europe or in Asia or the Middle East that really wants to do some clinical work on their home turf, if you will. And is willing to put some funds into that process to go ahead and get that specific regulatory approval. So we're in a world with access to unlimited capital, yes, we would go as quickly as we possibly could. But again, we want to make every dollar count these days. So our focus is still growing the strategy in the U.S. and Europe. However, opportunistically, when we can satisfy the needs of one of our pharma partners, we're happy to oblige.

因此，我們可能有一個位於歐洲、亞洲或中東某個特定國家的製藥合作夥伴，如果您願意的話，他們確實想在自己的地盤上進行一些臨床工作。並願意在過程中投入一些資金，以繼續獲得特定的監管批准。因此，我們生活在一個可以獲得無限資本的世界，是的，我們會盡快採取行動。但同樣，我們現在希望讓每一塊錢都發揮作用。因此，我們的重點仍然是在美國和歐洲發展戰略。然而，機會主義地，當我們能夠滿足我們的製藥合作夥伴之一的需求時，我們很樂意幫忙。

That was our last question. I would now like to turn it back to Joe Burnett for any closing remarks.

這是我們最後一個問題。現在我想請喬·伯內特發表結束語。

Once again, thank you to everyone interested in being a part of our team's journey here at ClearPoint. At this point, we are, in fact, sort of reiterating our guidance for the year of revenue between $25 million and $27 million, which you saw in our press release. This is an exciting time as we plan for new product and service launches across all 4 of our growth pillars.

再次感謝所有有興趣參與 ClearPoint 團隊旅程的人。事實上，此時此刻，我們有點重申了我們對今年收入 2500 萬至 2700 萬美元的指導，正如您在我們的新聞稿中看到的那樣。這是一個令人興奮的時刻，因為我們計劃在所有 4 個成長支柱上推出新產品和服務。

We've worked very hard to get to the spot and are excited for our team, but also for the patients that we hope to treat with these new devices and therapies in the near future. The patient and the family are why we are here and ultimately, we are working for. So thank you very much, and good night.

我們非常努力地到達現場，為我們的團隊感到興奮，也為我們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興奮。病人和家人是我們來到這裡的原因，也是我們工作的最終目標。非常感謝，晚安。

Thank you. This does conclude today's conference. We thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.

謝謝。今天的會議到此結束。我們感謝您的參與。此時您可以斷開線路，度過美好的一天。