Vicarious Surgical Inc (RBOT) 2025 Q2 法說會逐字稿

Good afternoon. Thank you for attending the Vicarious Surgical's 2025 second-quarter earnings call. My name is Cameron, and I'll be your moderator for today. (Operator Instructions)

午安.感謝您參加 Vicarious Surgical 2025 年第二季財報電話會議。我叫卡梅倫，今天我將擔任主持人。（操作員指示）

And I would now like to pass the conference over to your host, Marissa Bych from the Gilmartin Group. You may proceed.

現在我想將會議交給主持人，來自 Gilmartin 集團的 Marissa Bych。您可以繼續。

Good afternoon. Today, after market close, Vicarious Surgical released financial results for the three months ended June 30, 2025. A copy of the press release is available on the company website. 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 Hbarbor provisions of the Private Securities Litigation Reform Act of 1995.

午安.今天收盤後，Vicarious Surgical 公佈了截至 2025 年 6 月 30 日的三個月的財務業績。新聞稿副本可在公司網站上查閱。在我們開始之前，我想提醒您，管理層將在本次電話會議中發表聲明，其中包括聯邦證券法所定義的前瞻性聲明，這些聲明是根據 1995 年《私人證券訴訟改革法》的安全條款做出的。

Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. All forward-looking statements, including, without limitation, those relating to obtaining approval for the Vicarious Surgical System and timing for any such approval, the timing of future clinical trials and FDA submissions, cash burn expectations, our operating trends and future financial performance, expense management, market opportunity and commercialization are based upon our current estimates and various assumptions.

本次電話會議中包含的任何與未來事件、結果或表現的預期或預測有關的陳述均為前瞻性陳述。所有前瞻性陳述，包括但不限於與 Vicarious Surgical System 批准和任何此類批准的時間、未來臨床試驗和 FDA 提交的時間、現金消耗預期、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。

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. 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.

這些聲明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聲明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聲明。有關與我們的業務相關的風險和不確定性的清單和說明，請參閱我們向美國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 10-K 表格和 10-Q 表格。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 12, 2025. 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.

本次電話會議包含時間敏感訊息，僅截至今天（2025 年 8 月 12 日）的現場直播時準確。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，除非法律要求，無論是由於新資訊、未來事件或其他原因。

I will now hand the call over to Adam Sachs, Co-Founder and President, to begin prepared remarks. Adam?

現在，我將把電話交給聯合創始人兼總裁亞當·薩克斯 (Adam Sachs)，開始發表準備好的演講。亞當？

Thank you, Marissa. Good afternoon, everybody. It's been an incredible journey leading Vicarious Surgical since its founding. From our earliest days through product development and preclinical testing, I have been continually inspired by the dedication of our team and the strength of our mission. Today, I am proud of the foundation we have built, and I'm even more excited about what lies ahead.

謝謝你，瑪麗莎。大家下午好。自 Vicarious Surgical 成立以來，領導該公司經歷了一段不可思議的旅程。從我們最初的產品開發和臨床前測試開始，我一直受到我們團隊的奉獻精神和我們使命的力量的啟發。今天，我為我們已經建立的基礎感到自豪，對未來更加充滿期待。

With that in mind, I am pleased to welcome Stephen From as our new Chief Executive Officer. Stephen brings a strong track record of leadership across the health care and medtech industries. And he joins us at a pivotal moment in our company's evolution. His experience and perspective will be invaluable as we continue progressing toward our long-term goals.

考慮到這一點，我很高興歡迎 Stephen From 擔任我們的新任執行長。史蒂芬在醫療保健和醫療技術行業擁有豐富的領導經驗。他在我們公司發展的關鍵時刻加入了我們。當我們繼續朝著我們的長期目標前進時，他的經驗和觀點將是無價的。

As I step into the role of President, I look forward to partnering with Stephen and the rest of our leadership team to build on the momentum we have created. Together, we remain focused on developing our technology, advancing our clinical programs and fulfilling our mission to transform surgical care through groundbreaking robotic innovation.

當我擔任總裁一職時，我期待與史蒂芬和我們領導團隊的其他成員合作，以鞏固我們所創造的勢頭。我們將繼續共同致力於開發我們的技術，推進我們的臨床項目，並完成透過突破性的機器人創新改變外科護理的使命。

Stephen will share more on this topic. But as we are also using the leadership transition to take a broader look at our development path, including both technical progress and program strategy.

史蒂芬將會就這個主題分享更多內容。但我們也利用領導層的過渡來更廣泛地審視我們的發展道路，包括技術進步和專案策略。

With that, I'd like to turn it over to Stephen to introduce himself and share an update on his approach.

接下來，我想請史蒂芬自我介紹並分享他的最新方法。

Great. Thank you, Adam. So to begin, I'd like to express how excited I am to join the Vicarious Surgical team. We're at an important inflection point in the company's journey, and I believe we have an extraordinary opportunity to redefine what is possible in robotic surgery. I'm grateful for the warm welcome I've received in my first few days, and especially to Adam for his thoughtful support.

偉大的。謝謝你，亞當。首先，我想表達一下我加入 Vicarious Surgical 團隊的興奮之情。我們正處於公司發展歷程中一個重要的轉折點，我相信我們有一個絕佳的機會來重新定義機器人手術的可能性。我很感激在最初幾天受到的熱烈歡迎，尤其感謝亞當對我的周到支持。

While it's still early in my tenure, I have been deeply impressed by the caliber of talent, the clarity of purpose and the passion that exists throughout this organization. It's clear that a bold and inspiring mission has been built here, and I'm honored to help carry that vision forward.

雖然我的任期還很短，但這個組織的人才水平、明確的目標和熱情給我留下了深刻的印象。顯然，這裡已經建立了一個大膽而鼓舞人心的使命，我很榮幸能夠幫助實現這個願景。

Over the past few days, I've begun to engage with the teams across all areas of business, listening, learning and gathering candid feedback on our product development, our clinical strategy, operations and organizational structure. These conversations have only strengthened my confidence in our platform, our people and the opportunity we have ahead of us.

在過去的幾天裡，我開始與各個業務領域的團隊接觸，傾聽、學習並收集有關我們的產品開發、臨床策略、營運和組織結構的坦誠回饋。這些對話只會增強我對我們的平台、我們的員工以及我們面臨的機會的信心。

Our technology represents a meaningful advancement in minimally-invasive surgery. The single-port robotic market is still in the early stages, and we believe we are in a position to advance the development of our technology. With a differentiated platform and a strong technical foundation, we are focused on executing with discipline and aligning around the milestones that will drive the long-term value.

我們的技術代表了微創手術的重大進步。單端口機器人市場仍處於早期階段，我們相信我們有能力推動我們的技術發展。憑藉差異化的平台和強大的技術基礎，我們專注於嚴格執行並圍繞推動長期價值的里程碑進行調整。

Before I pass the call to Sarah, I want to provide a brief update on system readiness and anticipated time lines. It is clear that Vicarious Surgical has an excellent dedicated team, and it has designed a great product with meaningful differentiation. My direction to the team is that the best use of company resources is to focus on completing a fully integrated production equivalent system, enabling design lock and initiating full system verification and validation. This will be our primary focus until completion with our first clinical patients to follow design lock.

在將電話轉給莎拉之前，我想簡要介紹一下系統準備和預計時間表。顯然，Vicarious Surgical 擁有一支優秀的專業團隊，並且設計出了具有顯著差異化的優秀產品。我對團隊的指示是，公司資源的最佳利用是專注於完成完全整合的生產等效系統，實現設計鎖定並啟動完整的系統驗證和確認。這將是我們的主要關注點，直到我們完成第一批臨床患者遵循設計鎖。

Through testing conducted during our ongoing build in preparation for our first clinical use trial, it became clear that proceeding now would require using a nonproduction equivalent system. While such a trial could provide some insights, it would divert our limited resources away from the higher priority goal of finalizing a production equivalent system. This strategic shift means removing the near-term target of an FCU by the end of 2025, and instead concentrating all efforts on completing system design and readiness for full verification on a system that is ready to commercialize.

透過我們在為首次臨床使用試驗做準備的過程中進行的測試，很明顯現在繼續進行需要使用非生產等效系統。雖然這樣的試驗可以提供一些見解，但它會將我們有限的資源從最終確定生產等效系統的更高優先目標上轉移開。這項策略轉變意味著取消2025年底前實現FCU的近期目標，而是集中所有精力完成系統設計，並為準備商業化的系統進行全面驗證。

The expected timing of other future clinical trial milestones, including submission of a de novo filing, will in turn depend on FCU timing. So we'll conduct a deep dive into every aspect of our build to secure verification for a production-ready system. This effort is critical not only for ensuring technical readiness, but also for generating a clear picture of our progress and readiness over the next month. I anticipate this assessment could approximately take about four to six weeks. And at that point, I expect to have greater clarity on our development status, timing to complete system integration and readiness to initiate full system verification.

未來其他臨床試驗里程碑的預期時間（包括提交 de novo 文件）將取決於 FCU 時間。因此，我們將深入研究建置的各個方面，以確保生產就緒系統的安全驗證。這項工作不僅對於確保技術準備至關重要，而且對於清楚了解我們下個月的進展和準備也至關重要。我預計這次評估大約需要四到六週的時間。到那時，我希望能夠更清楚地了解我們的開發狀態、完成系統整合的時間以及啟動全面系統驗證的準備情況。

I will continue to work closely with our technical and strategic teams to refine our time lines, evaluate progress across our development programs and assess the resources needed to support our next phase. I also plan to continue engaging with our Board and our investor base as we evaluate the capital strategy that will best support our objectives.

我將繼續與我們的技術和策略團隊密切合作，完善我們的時間表，評估我們開發計劃的進展，並評估支援下一階段所需的資源。我還計劃繼續與我們的董事會和投資者群體合作，以評估最能支持我們目標的資本策略。

With that, I'll turn it over to Sarah Romano, our CFO, to walk you through the financials.

接下來，我將把時間交給我們的財務長 Sarah Romano，她將為您介紹財務狀況。

Thank you, Stephen. Total operating expenses for the second quarter of 2025 were $13.5 million, a 24% decrease compared to $17.7 million in the second quarter of 2024. Our research and development expenses for the second quarter 2025 were $9.1 million compared to $10.9 million in the second quarter 2024.

謝謝你，史蒂芬。2025 年第二季的總營運費用為 1,350 萬美元，與 2024 年第二季的 1,770 萬美元相比下降了 24%。我們 2025 年第二季的研發費用為 910 萬美元，而 2024 年第二季為 1,090 萬美元。

General and administrative expenses for the second quarter 2025 were $4.1 million compared to $5.6 million in the second quarter 2024. And finally, second quarter 2025 sales and marketing expenses was $300,000 compared to $1.2 million in the second quarter of 2024.

2025 年第二季的一般及行政費用為 410 萬美元，而 2024 年第二季為 560 萬美元。最後，2025 年第二季的銷售和行銷費用為 30 萬美元，而 2024 年第二季為 120 萬美元。

Our GAAP net loss for the second quarter 2025 was $13.2 million or $2.23 per share. This compares to a net loss of $15.2 million or $2.59 per share in the second quarter of 2024. Non-GAAP adjusted net loss for the second quarter 2025 was $13.3 million or $2.23 per share as compared to $16.8 million or $2.86 per share in the second quarter 2024.

我們 2025 年第二季的 GAAP 淨虧損為 1,320 萬美元，即每股 2.23 美元。相比之下，2024 年第二季的淨虧損為 1,520 萬美元，即每股 2.59 美元。2025 年第二季非 GAAP 調整後淨虧損為 1,330 萬美元，即每股 2.23 美元，而 2024 年第二季為 1,680 萬美元，即每股 2.86 美元。

For a reconciliation of all non-GAAP measures to GAAP, please review our earnings press release. We ended the second quarter of this year with approximately $24 million of cash, cash equivalents and short-term investments on our balance sheet. This represents a second quarter cash burn rate of approximately $13.4 million.

若要了解所有非 GAAP 指標與 GAAP 指標的對照，請查看我們的收益新聞稿。截至今年第二季度，我們的資產負債表上擁有約 2,400 萬美元的現金、現金等價物和短期投資。這意味著第二季的現金消耗率約為 1,340 萬美元。

We continue to expect full year 2025 cash burn to be approximately $50 million, and we remain committed to disciplined capital allocation. We look forward to continuing to drive progress on our financial and clinical goals in the coming quarters.

我們繼續預計 2025 年全年現金消耗約為 5000 萬美元，並且我們仍然致力於嚴格的資本配置。我們期待在未來幾季繼續推動我們的財務和臨床目標的進展。

And with that, I'll turn the call back over to Stephen for closing remarks.

最後，我將把電話轉回給史蒂芬，請他做最後發言。

Thank you, Sarah. So I'd like to conclude by reiterating how deeply impressed I am by the strength of the technology, the caliber of the team and the company's clear commitment to transforming surgical care. While it's still early in my tenure, I look forward to thoroughly reviewing the company's work streams and processes to ensure we're aligned for long-term success. I'd like to express my gratitude to our dedicated team, supportive investors and valuable partners. And thank you all for your continued support and interest in Vicarious Surgical.

謝謝你，莎拉。最後，我想重申一下，我對該公司的技術實力、團隊的品質以及公司對改變外科護理的明確承諾印象深刻。雖然我的任期還很短，但我期待徹底審查公司的工作流程和流程，以確保我們能夠協調一致，並取得長期成功。我要向我們敬業的團隊、支持我們的投資者和寶貴的合作夥伴表示感謝。並感謝大家對 Vicarious Surgical 的持續支持與關注。

Operator, we are now ready to take questions.

接線員，我們現在可以回答問題了。

(Operator Instructions) Ryan Zimmerman, BTIG.

（操作員指示）Ryan Zimmerman，BTIG。

Can you hear me okay?

你聽見我說話嗎？

Yes.

是的。

So I appreciate, Stephen, you have to come in and kind of prioritize what's important and so forth. Maybe talk to us about kind of how you guys have gone about that process of deciding getting a system ready for use and needing to push back those time lines around clinical trials. And just how much money, I mean, has gone into preparing for those clinical trials and maybe either what's lost or what's saved as a result of some of those shifting time lines to extend your cash runway?

所以我很感激，史蒂芬，你必須介入並優先考慮什麼是重要的等等。也許可以和我們談談你們是如何決定讓一個系統準備好使用的，以及需要推遲臨床試驗的時間表的。我的意思是，為了準備這些臨床試驗，您投入了多少錢？由於時間軸的調整，您損失了多少錢？又省了多少錢？

Yes. Those are some really good questions there, Ryan. So I appreciate you bringing them to our attention. So look, I think -- I'll just be upfront about this. This is my fourth day here, okay?

是的。這些都是非常好的問題，瑞安。因此我很感謝您提請我們注意這些問題。所以，我想——我會坦率地談論這件事。這是我來這裡的第四天，好嗎？

I just started on Thursday of last week. So I'm really -- I've been spending a lot of time with everybody, really trying to get a really good grounding of where we are and what we're doing. And so what we've decided to do is put an exercise in place, where we really fully understand what's still required to get to a full production equivalent system and what is it we've completed today.

我上週四才開始。所以我真的——我花了很多時間和大家在一起，真的試著好好了解我們目前的情況和我們正在做的事情。因此，我們決定進行一項演習，以便我們真正全面地了解要實現完全生產等效系統還需要什麼，以及我們今天已經完成了什麼。

So it's not so much that -- I understand what you're saying about changing the time lines. The FCU is extremely important to the company, as we all understand, I think that's obvious. But I want to make sure also that we're doing that FCU on the right system. And that may sound not so obvious, but as we go through the testing of the system that we've integrated, we may come across things that require us to maybe do a little bit of extra work on what we were testing. And so we could continue to rush forward on a system where additional testing or additional development may be required based on some of the testing that we've done, or we could step back and say, let's just focus on making sure we get all of the right development finished based on the testing that's been done to date so that we have what we take into the clinic is a system that we can move very quickly to commercialization.

所以這並不是說——我理解你所說的改變時間線的意思。眾所周知，FCU 對公司極為重要，我認為這是顯而易見的。但我也想確保我們在正確的系統上執行 FCU。這聽起來可能不太明顯，但當我們對整合的系統進行測試時，我們可能會遇到一些需要我們在測試上做一些額外工作的事情。因此，我們可以繼續推進一個系統，在這個系統中，根據我們已經完成的一些測試，可能需要進行額外的測試或額外的開發，或者我們可以退一步說，讓我們只專注於確保我們根據迄今為止所做的測試完成所有正確的開發，這樣我們就可以把我們帶入臨床的系統快速推向商業化。

And I think as a small company with limited resources, I don't believe we have the luxury to have multiple different systems that we're taking into the clinic. And so that leads us and segues into the next part. There hasn't really been any cash or very -- it's very minimal. It's immaterial that's been spent to date on a clinical trial or setting up and getting ready. Any type of groundwork that's required to start a clinical trial is really -- it's not work that requires spending money.

我認為，作為一家資源有限的小公司，我們沒有足夠的能力將多個不同的系統引入診所。這引導我們進入下一部分。實際上沒有任何現金，或者說非常少的現金。迄今為止在臨床試驗或設置和準備上花費的錢並不重要。開始臨床試驗所需的任何類型的基礎工作實際上都不是需要花錢的工作。

It's some resources, but the resources are going to be more labor intense. So there's really no money that's been spent or wasted on that.

這是一些資源，但這些資源將會更加勞力密集。因此實際上並沒有花費或浪費任何錢。

Okay. Well, fair enough. I guess, what was anticipated to be spent on those clinical trials? And how does that factor into your cash burn guidance or the runway you have with the existing cash?

好的。嗯，很公平。我猜，這些臨床試驗預計要花多少錢？這對您的現金消耗指引或現有現金的運作有何影響？

Well, look, again, I'm 4 days into this. So I've got a lot that I've got to get my head around that I need to right now learn and focus on.

好吧，再說一遍，我已經堅持了四天了。因此，我有很多事情需要我去思考，我現在需要學習並集中精力。

Maybe let's ask Sarah.

也許我們可以問問莎拉。

Yes. So budgeted costs around clinical trials, it's actually not overly material to our budget, believe it or not. So a lot of the cost for this FCU, it's not going to make a major change in our overall 2025 budget. I think going forward, that may change as we continue to evaluate. But currently, in this year, it won't be materially different.

是的。因此，無論你信不信，圍繞臨床試驗的預算成本實際上對我們的預算來說並不是太重要。因此，FCU 的大部分成本不會對我們 2025 年的整體預算產生重大影響。我認為，隨著我們繼續評估，這種情況可能會改變。但目前，就今年而言，情況不會有實質的改變。

Josh Jennings, TD Cowen. (Operator Instructions)

喬許‧詹寧斯 (Josh Jennings)，TD Cowen。（操作員指示）

This is Eric on for Josh. I appreciate the update on the strategy and new development targets. And I understand it might take some time to work with the team before you have a better idea of exact timing. But in terms of milestones that investors should expect for this year, are you able to share which of the development and system milestones you think you could have achieved, say, by the end of this year?

我是埃里克，代替喬希。我很欣賞有關策略更新和新的發展目標。我知道您可能需要花一些時間與團隊合作才能更好地了解確切的時間。但是就投資者今年應該期待的里程碑而言，您能否分享一下您認為在今年年底前可以實現哪些開發和系統里程碑？

I think it's early days right now, and it's hard to put an actual date on the calendar for anything other than the first -- this first exercise is -- it is really fundamentally important for what we're trying to accomplish here. And I need full visibility on that, and it's going to take a little bit of time to get there. What we're going to complete by the end of this year, I think, will become more apparent once I've been able to get through this exercise. And I hate to mislead anybody. And that's what I don't -- I want to just say upfront, I'm not trying to punt anything to the future.

我認為現在還為時過早，除了第一次演習之外，很難在日曆上為其他任何事情確定一個實際日期——第一次演習——對於我們在這裡試圖完成的目標來說，它確實至關重要。我需要對此有全面的了解，但這需要一點時間。我認為，一旦我完成這項練習，我們在今年年底前要完成的任務就會變得更加清晰。我不想誤導任何人。這就是我不想做的事——我只是想提前說，我並不想把任何事情推遲到未來。

What I'm trying to say is I don't want to provide you with misleading guidance.

我想說的是，我不想給你誤導的指導。

I want to make sure that I have clarity, and that when I give you something and I'm verbally telling you and giving you guidance that you can rely on that, okay? And we're not putting anything on hold for us to do this exercise. Most of this information already exists. It's a matter of me gathering it and getting the right questions answered, all right, so that we can do this. And I think this is going to be really helpful for all the investors that I've been talking to over the last few weeks and so forth.

我想確保我表達清楚，當我給你一些東西，我口頭告訴你，給你指導，你可以依賴它，好嗎？為了進行這項演習，我們不會暫停任何事情。這些資訊大部分已經存在。我需要收集這些資訊並得到正確問題的答案，這樣我們才能做到這一點。我認為這對過去幾週我與之交談過的所有投資者都非常有幫助。

It's very important for them to have guidance that they can rely on. And so give me the grace of finding all the detail out so that I can provide you with that type of guidance.

對他們來說，獲得可以信賴的指導非常重要。因此，請允許我找出所有細節，以便我可以為您提供此類指導。

Sure. Understood. That makes sense. And then maybe just on the balance sheet with the cash and investments that you have on hand now, I was hoping you could talk about how you feel about your ability to continue funding development and some of the other work that is ahead of the company.

當然。明白了。這很有道理。然後也許只是在資產負債表上，根據您現在手頭上的現金和投資，我希望您可以談談您對繼續資助開發和公司面臨的其他一些工作的能力的看法。

Yes, it's a good question. And obviously, there's a lot of variables at play here. We're a microcap company. It's a difficult environment. But the -- look, there's a fundamental reason why I joined this company, okay?

是的，這是個好問題。顯然，這裡有很多變數在起作用。我們是一家小型資本公司。這是一個艱難的環境。但是──你看，我加入這家公司有一個根本原因，好嗎？

There is a system here that we're building where there's a real need. This is something that nobody has ever even attempted to build before. There is a need here for this. The fact that there's a need here, I'm coming in actually in a luxury position because we can see the goal line. once we hit that goal line of actually having the fully integrated the production equivalent system ready for full verification and validation, everything becomes much easier after that, believe it or not, because of the system we are building.

我們正在根據實際需要建立一個系統。這是以前從未有人嘗試建造的東西。這裡確實有這個需要。事實上，這裡存在需求，我實際上處於一個奢侈的位置，因為我們可以看到目標線。一旦我們達到了這個目標線，即實際上擁有完全整合的生產等效系統，準備好進行全面的驗證和確認，之後一切都會變得容易得多，不管你信不信，因為我們正在建立系統。

And I'm coming in where all -- a lot of the heavy lifting has already been done. A lot of these major problems have already been solved, okay? So I have that luxury.

當我來到這裡時，很多繁重的工作已經完成了。很多重大問題已經解決，好嗎？所以我有這樣的奢侈。

And so I'm seeing where we are and I see what we have. I see an industry here, which is dominated by one player, and I see a lot of others that are trying to copy what they're doing, and I saw this team wasn't. This team was actually approaching a problem that needed solving. They weren't trying to copycat somebody that was already successful. And so that's what brought me on board to this company.

因此，我知道我們現在處於什麼位置，也知道我們擁有什麼。我看到這裡的一個行業被一個參與者所主導，我看到很多其他人都在試圖模仿他們所做的事情，但我看到這個團隊沒有這樣做。這個團隊實際上正在解決一個需要解決的問題。他們並不是想模仿已經成功的人。這就是我加入這家公司的原因。

And what I've learned over the last 4 days is the actual people here are amazing. They have the right people here. They are people that can solve problems and get this system built. So what I need now is to be able to be in a position to provide guidance to the investors as to when all that's going to happen. And yes, I could throw dates out, but they're not going to mean anything.

過去四天來，我了解到這裡的人們真的非常棒。他們這裡有合適的人選。他們是能夠解決問題並建立這個系統的人。所以我現在需要的是能夠為投資人提供指導，告訴他們這一切何時會發生。是的，我可以說出一些日期，但它們並不意味著什麼。

So I need to get the work done so that I can give you dates that actually have meaning behind them.

所以我需要完成這項工作，以便我可以給你真正有意義的日期。

But when we get this system built, it's going to be a system that's going to be able to obviously get market share because of what we're going to be providing, okay? And look, the markets are hard, but I'm going out there telling people that it's -- this is a project and this is a system and a company that is worth investing in for the long term because this is a system that isn't just a copycat. This is a system that deserves market share because it's solving a real problem that exists today that nobody else is going after, okay?

但是當我們建立這個系統時，它將是一個能夠透過我們所提供的服務獲得市場份額的系統，好嗎？瞧，市場很艱難，但我要告訴人們，這是一個值得長期投資的專案、一個系統、一個值得長期投資的公司，因為這個系統不只是一個模仿者。這個系統值得擁有市場份額，因為它解決了當今存在的一個實際問題，而沒有人可以解決，好嗎？

So first of all, we need to make sure that we have something that people want. If people want that, they're going to -- that provides us with this market opportunity, which I can share with investors. Now the investors need to get confidence that we can actually deliver on that. And that's what I need time to do is to give them the confidence on what time it's going to take to deliver on that. And -- but we're not talking that it's going to take forever.

因此首先，我們需要確保我們擁有人們想要的東西。如果人們想要，他們就會——這為我們提供了這個市場機會，我可以與投資者分享。現在投資者需要相信我們確實能夠實現這一目標。我需要時間去做的事情就是讓他們有信心知道需要多長時間才能實現這一目標。而且——但我們並不是說這會花很長時間。

We -- like I tell you, we can already see that goal line. It's a matter of what's left to do to get there.

我們——就像我告訴你的，我們已經可以看到那條球門線了。問題在於要達到這個目標還需要做些什麼。

Adam Maeder, Piper Sandler.

亞當梅德、派珀桑德勒。

Just a couple from me, and I kind of wanted to pull a little bit on the same thread as Ryan was asking about. And I guess, the first question that I have is, it's clear based on the prepared remarks, you don't feel that the system is ready to kind of push forward to first-in-human at this point. But I just wanted to, I guess, kind of better understand what led you to that conclusion. Is it something on the hardware? Is it instruments?

這只是我的幾點想法，我有點想對 Ryan 所問的同一個主題做一點補充。我想，我的第一個問題是，根據準備好的發言，很明顯您認為目前系統還沒有準備好推進首次人體試驗。但我想我只是想更好地理解是什麼讓你得出這個結論。這是硬體上的問題嗎？是樂器嗎？

Is it software? Just general bugs that you're seeing in the system that need to be worked out? Just help us understand kind of what you're looking to troubleshoot going forward? And then I had a follow-up.

它是軟體嗎？您在系統中看到的只是需要解決的一般錯誤嗎？只是幫助我們了解您接下來想要解決的問題是什麼嗎？然後我進行了後續跟進。

Yes. So I'll take that one, Adam, and I appreciate the question. So the way to think about kind of our previous plan and strategy that I laid out is that the goal was to take the system that we have, integrate it and then bring it through the sort of preliminary V&V testing in order to bring it into our first clinical use. And we kind of understood and communicated that a handful of things can go wrong and can be -- but could -- as long as they don't affect safety or efficacy and can be mitigated in a controlled clinical trial setting, we could still bring it into the clinic safely. And we could still do that.

是的。所以我接受這個問題，亞當，我很感謝這個問題。因此，我思考我們之前製定的計劃和策略的方式是，目標是採用我們現有的系統，對其進行整合，然後進行初步的 V&V 測試，以便將其投入我們的首次臨床使用。我們理解並傳達了這樣的訊息：有些事情可能會出錯，而且可能會——但有可能——只要它們不影響安全性或有效性，並且可以在受控的臨床試驗環境中得到緩解，我們仍然可以安全地將其帶入臨床。我們仍然可以這樣做。

But Stephen's direction, especially communicating and working with the team over the past couple of weeks, leading up to start in the last week here is that the amount of effort to do that is, to some degree, wasted effort. Like I don't really want to say wasted, but with a company with such limited resources, we would be taking the things that didn't work, and testing them thoroughly to make sure they're safe and then justifying them for use in the clinic. And that's a huge amount of work. So I'll give a specific example here. And we took our surgeon console to TUV to do the 60601 testing, and it passed everything except for EMC testing.

但史蒂芬的指示，特別是過去幾週與團隊的溝通和合作，以及在最後一周開始之前，這樣做的努力在某種程度上是浪費的。就像我真的不想說浪費，但是對於一家資源如此有限的公司來說，我們會採取那些不起作用的東西，並對其進行徹底的測試以確保它們的安全，然後證明它們適合在臨床上使用。這是一項艱鉅的工作。所以我在這裡舉一個具體的例子。我們將外科醫生控制台帶到 TUV 進行 60601 測試，除了 EMC 測試外，它通過所有測試。

There were excessive emissions actually coming from the ergonomic stages that like make the system comfortable for the surgeon. That's not a big deal. We can fix that. It will take a couple of months.

實際上，過多的排放來自於人體工學階段，這些階段旨在讓外科醫生感覺舒適。這沒什麼大不了的。我們可以解決這個問題。這將需要幾個月的時間。

But in order to then go into an FCU by the end of the year, what we need to do is turn off those ergonomic stages, set them up for the surgeon doing it. Turn them off in order to make sure that it's safe and not overly emitting in the clinical setting and then do additional testing to ensure that while they're turned off, that it's still safe and that there's no real risk that the surgeon would need to adjust the ergonomic stages during the procedure. And coming in and seeing a handful of these issues, none of which are individually deal breaking, but each of which will take effort and time away from getting into our pivotal study and getting to that milestone of actually being able to do system verification on the full production equivalent system, Stephen's direction has been really clear that we need to focus on that and focus on getting to the endpoint rather than getting into the clinic as soon as possible.

但為了在年底前進入 FCU，我們需要做的是關閉那些人體工學階段，並為外科醫生設定。關閉它們以確保其安全性並且在臨床環境中不會過度發射，然後進行額外的測試以確保在關閉它們時仍然是安全的並且不存在外科醫生需要在手術過程中調整人體工學階段的實際風險。看到這些問題，雖然單獨來看不會對交易造成重大影響，但每個問題都需要花費我們大量的精力和時間，使我們無法進行關鍵研究，無法達到在完整生產等效系統上進行系統驗證的里程碑，斯蒂芬的指示非常明確，我們需要專注於此，專注於達到終點，而不是盡快進入臨床。

Okay. I got it. That's really helpful color, Adam. I appreciate all that. And I guess, for the follow-up, I realize you're not giving specific dates in terms of clinical milestones, first-in-human, et cetera.

好的。我得到了它。這顏色真的很有幫助，亞當。我對此表示感謝。我想，對於後續研究，我意識到您沒有給出臨床里程碑、首次人體試驗等方面的具體日期。

But I guess, I'm just trying to understand the messaging around how we should think about a potential shift to the time lines. So you have the four to six weeks of kind of review assessment. In the best case scenario, do you get moving pretty quickly after that review period and potentially still get into first-in-human later this year? Or should we assume that it's going to be a little bit more of kind of like a heavy lift, potential parts of the system have to be redesigned and a more significant push out? I'm just trying to understand if this is something that's going to slide by a couple of months or if it's going to be more dramatic than that.

但我想，我只是想了解關於我們應該如何看待時間軸的潛在轉變的資訊。所以你需要進行四到六週的複習評估。在最好的情況下，您是否能在審查期結束後迅速採取行動，並有可能在今年稍後進入首次人體試驗階段？或者我們應該認為這會更像一項艱鉅的任務，系統的潛在部分必須重新設計，並且需要更重要的推動？我只是想知道這是否會在幾個月內推遲，或者是否會比這更具戲劇性。

Yes. No, I appreciate it. Back to me, it's Stephen here. And look, it's exactly the question I'm asking myself right now. So I wish I could tell you, and I wish I could -- I would love to just throw out and say -- I don't -- I can't even tell you -- I can't give you any guidance right now just because I can't answer that question faithfully.

是的。不，我很感激。回到我這裡，我是史蒂芬。瞧，這正是我現在問自己的問題。所以我希望我能告訴你，我希望我能——我很想直接說——我不能——我甚至不能告訴你——我現在不能給你任何指導，因為我不能忠實地回答這個問題。

But I'm telling you we can see the goalpost. So it's not like we're saying that this is -- in fact, I don't even want to say that. I don't know. Let me have this assessment. Give me that luxury of having this assessment, and then we can tell you exactly where we are.

但我告訴你，我們可以看到球門柱。所以這並不是說我們說這是——事實上，我甚至不想這麼說。我不知道。讓我來評估一下。請允許我進行這次評估，然後我們就可以準確地告訴您我們目前所處的位置。

Like does this shift this out a month? Does it shift this out three months? I don't know what it does. I have no idea. That's why I'm here.

這會將其推遲一個月嗎？這會延後三個月嗎？我不知道它是做什麼的。我不知道。這就是我來這裡的原因。

I'm wanting to take a snapshot photo of where we are and what's left to do, and that will give us a really good idea and indication of a timeline.

我想拍一張我們現在的位置和還剩下什麼事情要做的快照，這將給我們一個很好的想法和時間表的指示。

That was our final question. I would now like to pass the conference back to management for any closing remarks.

這是我們的最後一個問題。現在，我想將會議交還給管理階層，請他們發表結束語。

Yes. I think -- look, those are all great questions, and I think they're spot on. And the funny thing is those are the questions I'm asking myself. They are the questions the Board is asking. They're the reason I'm here.

是的。我認為——看，這些都是很好的問題，而且我認為它們是正確的。有趣的是，這些正是我問自己的問題。這些都是董事會提出的問題。他們就是我來這裡的原因。

And so I wish I could give you the answer my fourth day in, but I can't. And so I need a little bit of time here to get this over -- to get this exercise over. But I am so excited. I'm telling you, I thought I was excited doing my due diligence before I joined. But as I've been through, it's been -- they've been heavy four days, and I've been through a lot of meetings and discussions.

所以我希望我能在第四天給你答案，但我不能。所以我需要一點時間來完成這個練習。但我很興奮。我告訴你，我以為在加入之前我很高興能盡職盡責。但正如我所經歷的，這四天非常忙碌，我參加了很多會議和討論。

I'm actually really excited about seeing that the goal line is becoming more visible to me as I learn more and more about where we are with the system. That's it for me. So thank you, everyone.

事實上，當我越來越了解我們在系統中的處境時，我很高興看到目標線對我來說變得越來越清晰。對我來說就是這樣。謝謝大家。

Yes. Thank you, everybody, for joining. That concludes the call.

是的。謝謝大家的參與。通話到此結束。

That concludes today's call. Thank you for your participation, and enjoy the rest of your day.

今天的電話會議到此結束。感謝您的參與，祝您今天過得愉快。