Vicarious Surgical Inc (RBOT) 2024 Q3 法說會逐字稿

Hello, everyone, and welcome to Vicarious Surgical's third-quarter 2024 earnings call. My name is Lydia, and I'll be your operator today. (Operator Instructions) I'll now hand you over to Kate Brosco, Director of IR to begin. Please go ahead.

大家好，歡迎參加 Vicarious Surgical 的 2024 年第三季財報電話會議。我叫莉迪亞，今天我將成為您的接線生。（操作員指示）我現在將您交給 IR 總監 Kate Brosco 開始。請繼續。

Thank you, Lydia, and thank you all for joining. With me today are Adam Sachs, Co-Founder and Chief Executive Officer; Bill Kelly, Chief Financial Officer; and Randy Clark, Company President.

謝謝莉迪亞，也謝謝大家的加入。今天與我在一起的有共同創辦人兼執行長 Adam Sachs；比爾凱利，財務長；蘭迪·克拉克（Randy Clark），公司總裁。

Today, after market closed, Vicarious Surgical released financial results for the three months ended September 30, 2024. A copy of the press release is available on the company website.

今天收盤後，Vicarious Surgical 發布了截至 2024 年 9 月 30 日的三個月財務表現。新聞稿的副本可在公司網站上取得。

Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements.

在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據美國《私人證券訴訟改革法案》的安全港條款制定的。本次電話會議中包含的任何與對未來事件、結果或績效的預期或預測相關的陳述均為前瞻性陳述。

All forward-looking statements, including, without limitation, those relating to obtaining approval for the Vicarious Surgical System and timing for any such approval, our operating trends and future financial performance, expense management, market opportunity and commercialization are based upon our current estimations and various assumptions. These statements involve material risks and uncertainties that would cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place any undue reliance on these statements.

所有前瞻性陳述，包括但不限於與獲得替代手術系統批准以及任何此類批准的時間表、我們的營運趨勢和未來財務業績、費用管理、市場機會和商業化有關的陳述均基於我們當前的估計和各種假設。這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件有重大差異。因此，您不應過度依賴這些陳述。

For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors set forth in our Securities and Exchange Commission filings, including our most recent Form 10-K and Form 10-Q. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 12, 2024.

有關與我們業務相關的風險和不確定性的清單和描述，請參閱我們向證券交易委員會提交的文件中列出的風險因素，包括我們最新的表格 10-K 和表格 10-Q。本次電話會議包含時效性訊息，僅截至今天（2024 年 11 月 12 日）直播時準確。

Vicarious Surgical disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. Now I'll hand the call over to Adam for prepared remarks.

除法律要求外，Vicarious Surgical 不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或義務，無論是由於新資訊、未來事件或其他原因。現在我將把電話轉交給 Adam，讓他準備好演講稿。

Good afternoon, everyone. Thank you for taking the time to join us today. At Vicarious Surgical, our mission is to improve lives by transforming robotic surgery. And we believe our unique single-port platform will revolutionize surgery by enhancing patient outcomes, improving the surgical experience, and increasing the efficiency of care delivery. Just as multiport robotics advanced minimally invasive surgery beyond traditional open and laparoscopic techniques over two decades ago, single-port robotics is set to redefine the field once more.

大家下午好。感謝您今天抽空加入我們。在 Vicarious Surgical，我們的使命是透過改造機器人手術來改善生活。我們相信，我們獨特的單端口平台將透過改善患者治療效果、改善手術體驗和提高護理效率來徹底改變手術。正如二十多年前多端口機器人技術超越了傳統的開放式和腹腔鏡技術的微創手術一樣，單端口機器人技術也將再次重新定義該領域。

With its inherent advantages, single-port promises to unlock preoperative and interoperative efficiencies that intend to streamline procedures and increase surgical throughput where existing multiport devices fundamentally cannot. Furthermore, there is a growing base of evidence that supports single-port's ability to improve surgical outcomes for patients such as reduced blood loss, shorter hospital length of stay, and minimize pain and opioid use.

憑藉其固有的優勢，單一連接埠有望提高術前和術中效率，從而簡化手術並提高現有多連接埠設備根本無法做到的手術吞吐量。此外，越來越多的證據支持單孔能夠改善患者的手術結果，例如減少失血、縮短住院時間以及最大限度地減少疼痛和阿片類藥物的使用。

Not only do we see single-port surgery becoming a cornerstone of the surgical market for these reasons, but we also believe the unique feature set and clinical value of our single-port platform will further amplify these benefits and meaningfully expand upon them to set a new standard for minimally invasive care.

由於這些原因，我們不僅看到單孔手術成為手術市場的基石，而且我們還相信我們的單孔平台的獨特功能集和臨床價值將進一步放大這些優勢，並有意義地擴展它們，以建立一個微創護理的新標準。

During the third quarter, we made meaningful progress toward delivering the first version of our single-port platform. We are now weeks away from our year-end cadaver lab, which ultimately denotes the integration of the V1.0 System. Following the completion of this milestone, our focus will shift to verification and validation and the manufacturing effort to support this rigorous testing program.

在第三季度，我們在交付單埠平台的第一個版本方面取得了有意義的進展。現在距離年終屍體實驗室還有幾週的時間，這最終意味著 V1.0 系統的整合。完成這一里程碑後，我們的重點將轉向驗證和確認以及製造工作，以支持這項嚴格的測試計劃。

Starting early next year, the integrated V1.0 System and subsystems will undergo informal assessments related to durability, biocompatibility, and electromagnetic and environmental compatibility that will stimulate the formal verification and validation process.

從明年初開始，整合的 V1.0 系統和子系統將接受與耐久性、生物相容性以及電磁和環境相容性相關的非正式評估，這將刺激正式的驗證和確認過程。

We expect to make minor optimizations throughout this preliminary phase that will better ensure we meet all essential performance and safety standards required to treat our first clinical patients safely and confidently. Upon the successful completion of each of these rigorous essential performance and safety tests, we anticipate treating our first patient in less than one year. We look forward to this opportunity to showcase our single-port system's immense potential and the meaningful clinical value we can deliver to patients, surgeons, and hospital systems.

我們希望在整個初步階段進行細微的優化，以更好地確保我們滿足安全、自信地治療第一批臨床患者所需的所有基本性能和安全標準。在成功完成每項嚴格的基本性能和安全測試後，我們預計將在不到一年的時間內治療我們的第一位患者。我們期待有機會展示我們的單端口系統的巨大潛力以及我們可以為患者、外科醫生和醫院系統提供的有意義的臨床價值。

In preparation, our clinical and regulatory teams have been hard at work preparing with our CRO to evaluate potential OUS clinical sites for both our first clinical patient and subsequent pivotal clinical trial. Although no formal announcement has been made, we have narrowed our search down to a select few sites within the same country.

在準備過程中，我們的臨床和監管團隊一直在努力與 CRO 一起準備，以評估我們的第一位臨床患者和隨後的關鍵臨床試驗的潛在 OUS 臨床地點。儘管尚未發布正式公告，但我們已將搜尋範圍縮小到同一國家/地區內的選定幾個網站。

Conducting the first clinical patient ahead of our pivotal clinical trial will allow us to validate real-world performance in a clinical setting and gain valuable insights that can be used to optimize our pivotal trial design and protocol. As a reminder, in order to expedite our time to market, our clinical trial will focus on one initial indication, ventral hernia repair.

在我們的關鍵臨床試驗之前對第一位臨床患者進行治療將使我們能夠在臨床環境中驗證真實世界的表現，並獲得可用於優化我們的關鍵試驗設計和方案的寶貴見解。提醒一下，為了加快我們的上市時間，我們的臨床試驗將重點放在一個初步適應症，即腹疝氣修復術。

With hundreds of thousands of procedures performed annually within the U.S., ventral hernia repair is an attractive first indication for Vicarious Surgical and one where we believe our system's differentiated clinical capability is ideally suited. From there, we plan to quickly expand out to our other targeted indications, including inguinal hernia repair and procedures related to gynecology, gallbladder and colorectal.

在美國每年進行數十萬例手術，腹疝氣修補術是 Vicarious Surgical 極具吸引力的第一個適應症，我們相信我們系統的差異化臨床能力非常適合該適應症。以此為基礎，我們計劃迅速擴展到其他目標適應症，包括腹股溝疝氣修補術以及與婦科、膽囊和結直腸相關的手術。

Our clinical trial's primary performance endpoint will be the ability of the surgeon to complete the intended ventral hernia repair, and our safety endpoint will be adverse event rates through a 30-day post-surgery follow-up as compared to existing laparoscopic data. Following guidance from our pre-submission meetings with the FDA, including the most recent one last month, we plan to enroll and treat approximately 30 to 60 subjects from outside the United States.

我們的臨床試驗的主要表現終點將是外科醫生完成預期腹疝氣修復的能力，我們的安全終點將是與現有腹腔鏡數據相比，術後 30 天追蹤的不良事件發生率。根據我們與 FDA 的提交前會議（包括上個月舉行的最近一次會議）的指導，我們計劃招募和治療來自美國境外的約 30 至 60 名受試者。

We believe this approach will allow us to treat subjects and gather clinical data to demonstrate the safety and efficacy of our technology in the most efficient and timely manner. Additionally, numerous precedents, including recent FDA surgical robotic clearances give us further confidence in our regulatory pathway to market. I'll now turn the call over to Bill for a review of our third quarter financial performance.

我們相信，這種方法將使我們能夠以最有效和及時的方式治療受試者並收集臨床數據，以證明我們技術的安全性和有效性。此外，眾多先例，包括最近 FDA 手術機器人的許可，讓我們對我們的市場監管途徑更加充滿信心。我現在將把電話轉給比爾，要求他審查我們第三季的財務表現。

Thank you, Adam. As we enter the second half of the year, we continue to see the positive impact of our cost reduction initiatives taken last year. In the third quarter, total operating expenses fell 17% year over year to $17.8 million.

謝謝你，亞當。進入下半年，我們繼續看到去年採取的成本削減措施的正面影響。第三季總營運費用年減 17% 至 1,780 萬美元。

R&D expenses for the third quarter of 2024 were $10.8 million compared to $13 million in the third quarter of 2023. General and administrative expenses for the third quarter of 2024 were $5.7 million, down from $6.9 million in the third quarter of 2023.

研發2024 年第三季的支出為 1,080 萬美元，而 2023 年第三季的支出為 1,300 萬美元。2024 年第三季的一般及管理費用為 570 萬美元，低於 2023 年第三季的 690 萬美元。

And third quarter 2024 sales and marketing expenses were $1.2 million versus $1.4 million in the third quarter of 2023. Adjusted net loss for the third quarter of 2024 was $17 million, equating to an adjusted net loss of $2.87 per share as compared to an adjusted net loss of $20.4 million or $3.95 per share in the third quarter of 2023.

2024 年第三季的銷售和行銷費用為 120 萬美元，而 2023 年第三季為 140 萬美元。2024 年第三季調整後淨虧損為 1,700 萬美元，相當於每股調整後淨虧損 2.87 美元，而 2023 年第三季調整後淨虧損為 2,040 萬美元，即每股 3.95 美元。

GAAP net loss for the third quarter of 2024 was $17.1 million, equating to a net loss of $2.90 per share. This compares to a net loss of $15.7 million or $3.04 per share in the third quarter of 2023. For a reconciliation of all non-GAAP measures to GAAP, please review our earnings press release.

2024 年第三季 GAAP 淨虧損為 1,710 萬美元，相當於每股淨虧損 2.90 美元。相比之下，2023 年第三季的淨虧損為 1,570 萬美元，即每股虧損 3.04 美元。有關所有非公認會計準則衡量標準與公認會計準則的調整，請查看我們的收益新聞稿。

We closed the third quarter with $61 million in cash, cash equivalents, and short-term investments. This translates to a cash burn of approximately $12 million for the quarter, keeping us on track with our projected full year 2024 cash burn of roughly $50 million.

第三季結束時，我們擁有 6,100 萬美元的現金、現金等價物和短期投資。這意味著本季的現金消耗約為 1,200 萬美元，使我們能夠繼續實現 2024 年全年約 5,000 萬美元的現金消耗預期。

While we are laser-focused on executing our development strategy and achieving our first clinical milestone next year, we are equally committed to disciplined resource allocation and maintaining a strong balance sheet to ensure we are appropriately capitalized to reach these critical landmarks and deliver on our mission. And with that, I will turn the call back to Adam for closing remarks. Adam?

雖然我們專注於執行我們的發展策略並在明年實現我們的第一個臨床里程碑，但我們同樣致力於嚴格的資源分配和維持強大的資產負債表，以確保我們擁有適當的資本來實現這些關鍵里程碑並實現我們的使命。接下來，我將把電話轉回給亞當，讓他發表結束語。亞當？

Thanks, Bill. In this final quarter of 2024, we are making the final push to complete the integration of our Version 1.0 System. This significant development milestone has been our main objective and guiding focus throughout the year and achieving it will be a testament to the dedication and incredible effort of our entire team.

謝謝，比爾。在 2024 年最後一個季度，我們將為完成 1.0 版系統的整合做最後的努力。這個重要的發展里程碑一直是我們全年的主要目標和指導重點，而實現這一目標將證明我們整個團隊的奉獻精神和令人難以置信的努力。

I want to express my sincere gratitude to our dedicated employees for their tireless efforts and unwavering commitment. I also want to extend a heartfelt thank you to our hospital system partners who have generously dedicated countless hours to providing invaluable feedback that has helped us shape our Version 1.0 System.

我要對我們敬業的員工的不懈努力和堅定不移的承諾表示誠摯的謝意。我也要向我們的醫院系統夥伴表示衷心的感謝，他們慷慨地投入了無數的時間來提供寶貴的回饋，幫助我們塑造了 1.0 版系統。

The integration of our first version platform will set the stage for 2025, the year where we transition to a clinical stage company. In less than a year, we intend to treat our first patient and have a critical opportunity to validate the clinical value of our single-port system and its potential to further robotic surgery. We are incredibly excited for the future of Vicarious Surgical and for our potential to positively impact lives by transforming robotic surgery.

我們第一個版本平台的整合將為 2025 年奠定基礎，也就是我們過渡到臨床階段公司的一年。在不到一年的時間裡，我們打算治療第一位患者，並有一個關鍵的機會來驗證我們的單端口系統的臨床價值及其進一步機器人手術的潛力。我們對 Vicarious Surgical 的未來以及我們透過改造機器人手術對生活產生積極影響的潛力感到非常興奮。

Thank you to everyone who joined the call today. We appreciate your support and look forward to updating you on our continued progress in the quarters to come. Operator, we are now ready to take any questions.

感謝今天加入電話會議的所有人。我們感謝您的支持，並期待向您通報我們在未來幾季的持續進展。接線員，我們現在準備好回答任何問題。

(Operator Instructions) Josh Jennings, TD Cowen.

（操作員說明）Josh Jennings，TD Cowen。

Hi, this is Eric on for Josh. Thank you for taking the question. Maybe thinking about the first clinical patient, which is going to be treated in less than a year. I was wondering if you could give us any color on just the expected time between treatment of that first clinical patient and the time in which the pivotal trial will actually be getting underway. Is that something that is going to be following in pretty short order? Just wanted to get a sense of where things stand there.

大家好，我是艾瑞克（Eric）為喬許（Josh）代言。感謝您提出問題。也許會想到第一個臨床患者，他將在不到一年的時間內接受治療。我想知道您能否告訴我們從治療第一位臨床患者到關鍵試驗實際開始之間的預期時間。這是會在很短的時間內發生的事情嗎？只是想了解那裡的情況。

Yeah, Eric, thanks for the question. It's a good question. We are going to follow the first clinical patient as quickly as we can with our pivotal clinical trial. We've seen a number of pivotal trials in surgical robotics conducted outside the United States, recently, including some that have been conducted quite quickly, which would give us some time to be able to make modifications to our protocol based on the actual first clinical patient that we are able to treat and then enroll in our clinical trial as quickly as we can.

是的，艾瑞克，謝謝你的提問。這是一個好問題。我們將透過我們的關鍵臨床試驗盡快追蹤第一位臨床患者。最近，我們看到在美國境外進行了許多關於手術機器人的關鍵試驗，其中一些試驗進展得相當快，這將使我們有時間能夠根據實際的首次臨床對我們的方案進行修改我們能夠治療的患者，然後儘快參加我們的臨床試驗。

Understood. And then it sounds like you've identified a country for the OUS clinical sites. I was wondering if you could just talk a little bit about the criteria that you've been using in evaluating those site locations and how many -- in particular, how many sites you think you'd need to activate for the trial?

明白了。聽起來您已經為 OUS 臨床地點確定了一個國家。我想知道您是否可以簡單談談您在評估這些站點位置時使用的標準以及有多少個站點，特別是您認為需要啟動多少個站點來進行試用？

Yes. So we're looking at doing the trial at just a few sites. We don't want to go with too many. There are a number of criteria that we've been working with, with our CROs outside the US to help us select specific countries and specific sites.

是的。因此，我們正在考慮在幾個地點進行試驗。我們不想和太多人一起去。我們一直在與美國境外的 CRO 合作，遵循許多標準來幫助我們選擇特定國家和特定地點。

I'd say the top clinical criteria here really starts with the regulatory pathway and timeline more than the actual requirements for what we need to do. Rather, it's about the country's ability to quickly review a regulatory package and get back to us and the consistency of that review. In addition to that, you know, it's about patients in need of the procedure and total patient volume, which would be highly indicative of our ability to enroll patients quickly at each of those potential sites.

我想說，這裡的首要臨床標準實際上是從監管途徑和時間表開始的，而不是我們需要做的實際要求。相反，它關係到該國快速審查監管方案並向我們反饋的能力以及審查的一致性。除此之外，您知道，這還涉及需要手術的患者和患者總數，這高度表明我們有能力在每個潛在地點快速招募患者。

Understood. And if I could squeeze just one more in. Just with the final integration of the Version 1.0 System coming in a few weeks, are you able to specify what items remain outstanding? Thank you.

明白了。如果我能再擠進去一點就好了。幾週後版本 1.0 系統的最終整合即將完成，您能否指定哪些項目尚未完成？謝謝。

Yeah. So the next couple of weeks are really more than anything about getting the system up and running and really doing lab after lab in order to allow us to gain confidence in the functionality of the system and our ability to pass all of that validation testing that is going to require essentially cadaver and animal labs in order to pass. So it really is about just increased confidence, shaking out any bugs and bringing everything together.

是的。因此，接下來的幾週實際上比讓系統啟動和運行以及真正進行一個又一個的實驗室更重要，以便讓我們對系統的功能以及通過所有驗證測試的能力充滿信心。實驗室才能通過。所以這實際上只是增加信心，消除任何錯誤並將所有內容整合在一起。

That's great. Thank you.

那太棒了。謝謝。

Thank you for the question.

謝謝你的提問。

Adam Maeder, Piper Sandler.

亞當梅德，派珀桑德勒。

Hi, good afternoon, Adam, Bill, Randy. Thank you for taking the questions and congrats on the progress. That's actually a good segue into my first question. I just wanted to kind of better understand B&B next year and kind of what that process, so just maybe double-click on that for a minute. And then just one quick clarification on the first-in-human studies that you're going to do -- the first-in-human study that you can do outside the US next year. How many patients is that? Is that a single patient? Or is it multiple patients? And then I had a follow-up. Thanks.

嗨，下午好，亞當、比爾、蘭迪。感謝您提出問題並祝賀我們的進展。這實際上是我第一個問題的一個很好的延續。我只是想更好地了解明年的 B&B 以及該流程，所以也許只需雙擊它一分鐘即可。然後快速澄清一下您將要進行的首次人體研究——明年您可以在美國境外進行的首次人體研究。那有多少病人？這是一個單獨的病人嗎？還是多個患者？然後我進行了跟進。謝謝。

Yeah. So I'll answer the easy one first. It's going to be up to five patients for that first clinical patient study. It will likely be all at one site or two sites that are very close together. As far as what's included in verification and validation, it is a whole sort of tree of activities where you go through, manufacture everything, and split the units into everything from verification, which includes taking all of our requirements and making sure that our system is actually able to meet the system requirements that are set for that system. So this includes everything from our own motion performance requirements, sterilization requirements. Think of it much more as bench testing.

是的。所以我先回答簡單的問題。首次臨床患者研究將涉及最多五名患者。它可能全部集中在一個站點或兩個非常接近的站點。就驗證和確認中包含的內容而言，它是一整套活動樹，您將在其中經歷、製造所有東西，並將單元拆分為驗證中的所有內容，其中包括考慮我們的所有要求並確保我們的系統是實際上能夠滿足為該系統設定的系統要求。所以這包括我們自己的運動性能要求、滅菌要求等一切。更多地將其視為台架測試。

And then there's validation and validation is all about the user needs. So the hospital system partners that we've worked with have really helped us set our user needs to make sure that our device, frankly, delivers on the needs of the users. And validation is sort of the final check to ensure exactly that.

然後是驗證，驗證都是關於用戶需求的。因此，與我們合作的醫院系統合作夥伴確實幫助我們確定了使用者需求，坦白說，確保我們的設備能夠滿足使用者的需求。驗證是最後的檢查，以確保這一點。

Got it. That's helpful color. Thanks for that, Adam. And maybe just one for Bill. As we look ahead to 2025, just any early thoughts in terms of kind of cash burn for next year? And just remind us how you're thinking about current cash runway. Thanks again for taking the questions.

知道了。這是有用的顏色。謝謝你，亞當。也許只是比爾的一個。當我們展望 2025 年時，對於明年的現金消耗有什麼初步想法嗎？請提醒我們您如何看待目前的現金跑道。再次感謝您提出問題。

Appreciate it. Iin terms of your current cash runway, we're pleased to be able to announce today that we remain on track with our $50 million -- approximately $50 million cash burn guidance for this year. You'll recall last year, as part of the year-end earnings release, we formalized our cash burn guidance. For this year, and we'll look to do so at the same time at the next earnings call.

欣賞它。就您目前的現金跑道而言，我們今天很高興能夠宣布，今年我們仍將實現 5000 萬美元——大約 5000 萬美元的現金消耗指導。您還記得去年，作為年終收益發布的一部分，我們正式製定了現金消耗指引。今年，我們將在下一次財報電話會議上同時這樣做。

That being said, I think our cash burn, while the nature of some of that expenditures might change as we go from development expenditures to more material purchases and first clinical patient type expenditures, we believe they'll be in the ballpark of 2024 spending. We have cash runway through into 2026.

話雖這麼說，我認為我們的現金消耗，雖然隨著我們從開發支出轉向更多的材料採購和首次臨床患者類型支出，其中一些支出的性質可能會發生變化，但我們相信它們將在2024 年支出的範圍內。我們有一個持續到 2026 年的現金跑道。

That's helpful. Thanks, Bill.

這很有幫助。謝謝，比爾。

We have no further questions. So this concludes today's call. Thank you all for joining you. May now disconnect your line.

我們沒有其他問題了。今天的電話會議到此結束。感謝大家的加入。現在可以斷開您的線路。