Vicarious Surgical Q4 2024 Earnings Call Transcript

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Operator

Good afternoon. Thank you for attending the Vicaria Surgical's twenty twenty four Fourth Quarter and Full Year Earnings Call. My name is Cameron, and I will be your moderator for today. I would now like to pass the conference over to your host, Caitlin Brosgrove, Director of IR. You may proceed.

Kaitlyn Brosco
Kaitlyn Brosco
Director, Investor Relations at Vicarious Surgical

Thank you, Cameron, and thank you all for joining. With me on today's call is Adam Sachs, Co Founder and Chief Executive Officer and Randy Clark, Company President. Today after market closed, Vicarious Surgical released financial results for the three months and full year ended 12/31/2024. 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 harbor provisions of the Private Securities Litigation Reform Act of 1995.

Kaitlyn Brosco
Kaitlyn Brosco
Director, Investor Relations at Vicarious Surgical

Any statements contained in this call that are related to expectations, description 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, our operating trends and future financial performance, expense management, market opportunity and commercialization are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that 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. 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 ks and Form 10 Q.

Kaitlyn Brosco
Kaitlyn Brosco
Director, Investor Relations at Vicarious Surgical

This conference call contains time sensitive information and is accurate only as of the live broadcast today, 03/17/2025. 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. I'll now hand the call over to Adam for prepared remarks.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Thanks, Kate. Good morning, everyone, and welcome excuse me, good afternoon, everyone, and welcome to our fourth quarter and full year twenty twenty four earnings call. We appreciate you joining us today. At Vicarious Surgical, our mission is to improve lives by transforming robotic surgery. And 2024 was a pivotal year in advancing that mission.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Throughout the past year, we achieved a number of key development, regulatory and commercial milestones that have positioned us incredibly well for continued success in 2025. As we'll discuss in more detail today, these accomplishments have laid the groundwork for what we believe will be a truly transformative year ahead as 2025 marks our transition into a clinical stage company. Our most anticipated milestone in 2024 was the successful version one point zero system integration. As you may recall from our last earnings call, we were just weeks away from our year end Kadabra Lab, a critical event that would signify the achievement of this key development milestone. We're thrilled to share with CadaboloLab with the success demonstrating the functionality and performance of our V1.0 system in a cadaveric preclinical setting.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

This achievement represents a significant step forward in bringing our innovative innovative robotic surgery platform to market and validates the hard work and dedication of our entire team. The version one point zero system, the platform we intend to use in our first clinical use, is uniquely architected to deliver differentiated value to patients, surgeons and hospitals. Our proprietary decoupled actuators provide a novel mechanism of action, separating it apart from anything currently available. This innovative design allows our system to achieve minimally invasive outcomes through a single small 18 millimeter incision while still generating the high forces necessary to address a broad range of soft tissue indications. Furthermore, the decoupled actuators enable additional intra abdominal joints, eliminating the need for complex instrument triangulation and providing surgeons with 13 degrees of freedom per instrument for advanced dexterity and near three sixty degree visualization and anatomical access.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

We are incredibly excited about the potential of our first generation platform not only to make a meaningful impact in our initial target indication of ventral hernia repair, but also across a wide range of soft tissue procedures. Beyond its core surgical capabilities, the Virgin one point zero lays the foundation for future advanced AI features that leverage sensing technologies such as multimodal fluorescent wavelengths, lidar and dot projection, essentially the same suite of technologies used in self driving cars today. It is our unique approach to surgical robotics that has garnered significant interest from leading U. S. Hospital systems.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

In 2024, we continue to expand our community of top tier hospital system partners. We announced an agreement with Louisiana's premier academic health institution, LSU Health New Orleans. And toward the end of the year, we officially inked partnerships with two other major academic health networks, Tempe excuse me, Temple Health and University of Illinois Health. Like LSU Health New Orleans, Temple Health and UI Health are ideal regional partners with renowned academic and training programs. Temple Health, a leading Philadelphia academic medical center, offers comprehensive care to its network of hospitals, clinics and research institutions.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Their robust research infrastructure will be invaluable for post market system evaluation and validation. UI Health, anchored by the University of Illinois in Chicago, is a major regional referral center with a distinguished robotics program. Their integrated network of hospitals and clinics, combined with a strong focus on research and medical education, provides access to a diverse patient population and extensive clinical and robotic expertise. Our newest hospital system partners will be instrumental in developing and refining our medical education and training protocols, equipping healthcare professionals to effectively utilize our technology once on market. We are excited to partner with these esteemed experts to advance our shared mission of improving patient care and look forward to demonstrating this real world clinical value starting later this year with our first human cases.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

In preparation for the important milestone, our regulatory and clinical team dedicated twenty twenty four to developing necessary clinical protocol and evaluating potential international clinical sites. With their diligent efforts, we have narrowed down our search to a few state of the art sites and are now in the process of securing institutional epics committee approval for each respective site. Once all IEC approvals are granted, the next step in the regulatory process is to submit a comprehensive package to the Ministry of Health, often referred to as a technical dossier. This dossier will provide a thorough review of our system, addressing the key performance and safety requirements such as biocompatibility, sterility, electrical safety, functional testing and supporting cadaveric and animal data. Now that the version one point zero system integration is complete, our developed team has initiated the manufacturing build out of the instrument arms, camera and capital equipment required to support the rigorous testing schedule leading to our Ministry of Health Technical Dossier submission.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Throughout 2024, we've made significant strides in establishing a robust, scalable manufacturing foundation. We strategically built out and streamlined our internal manufacturing capabilities, while simultaneously selecting key manufacturing partners to provide additional capacity and expertise. This has strengthened our supply chain and built certain redundancies to mitigate potential disruption. We prioritize establishing relationships with trusted partners who share our commitment to quality and precision, ensuring we have the resources and expertise needed to meet our production goals. While we've made significant progress in our procurement and build efforts during the first month of this year, we've also encountered some instances of gating components and clear to build hurdles with a select few suppliers impacting the pace of inventory build up.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

We escalated these challenges with those suppliers while also leveraging our other suppliers and internal resources to mitigate the effort. But given the large quantities of inventory required, our schedules have experienced a limited impact. We still expect to treat our first clinical patients this year. However, it will be closer to year end. Consequently, we now expect our de novo submission to be late in 2026.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

They're focused on controlling what we're able, mitigating risks where possible and maintaining our commitment to delivering a safe and effective product. Now, before we turn to our 2024 financial results, I want to reiterate our excitement about our new CFO. As we announced last week, Sarah Romano will officially join us on April 1. Sara brings decades of financial leadership, including significant experience in capital markets and driving growth through fundraising and strategic corporate transactions, most recently at Antero Therapeutics and Kyra Pharmaceuticals. We're thrilled to welcome Sarah to the Vicarious Surgical team.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

For today, however, Randy will review our 2024 financials. I'll now turn the call over to him.

Randy Clark
Randy Clark
President at Vicarious Surgical

Thank you, Adam. And jumping into the financials, starting with total operating expenses for full year 2024, they were $66,600,000 down 17% year over year. R and D expenses for the full year 2024 were $40,200,000 down from $47,600,000 in 2023. General and administrative expenses totaled $21,900,000 in the full year 2024, down from $26,900,000 in 2023. In full year 2024, sales and marketing expenses were $4,500,000 compared to $6,200,000 in the prior year.

Randy Clark
Randy Clark
President at Vicarious Surgical

Adjusted net loss for the full year 2024 was $63,300,000 equating to an adjusted net loss of $10.75 per share as compared to an adjusted net loss of $76,300,000 or an adjusted net loss of $15.67 per share for the prior year. GAAP net loss for full year 2024 was $63,200,000 equating to a net loss of $10.74 per share as compared to a GAAP net loss of $71,100,000 or $14.6 per share for the full year 2023. For a reconciliation of all non GAAP measures to GAAP, please review our earnings press release. Our 2024 cash burn rate was $49,000,000 achieving a favorable variance from our original guidance of approximately $50,000,000 This resulted in a year end balance of approximately $49,000,000 in cash, cash equivalents and short term investments, and underscoring our commitment to financial discipline. Looking ahead to 2025, we again anticipate a cash burn of approximately $50,000,000 and we'll continue to actively monitor and evaluate market conditions and strategically reinforce our balance sheet at the appropriate time.

Randy Clark
Randy Clark
President at Vicarious Surgical

We look forward to updating you in the quarters to come as we execute on our business initiatives. With that, I'll turn the call back to Adam for closing remarks. Adam?

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Thanks, Randy.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

I'd like to close out by reiterating the significant progress we've made throughout 2024. We successfully integrated our version one point zero system, built a robust supply chain and manufacturing foundation, forged new key partnerships with leading hospital systems and took meaningful steps toward treating our first patients this year. As of today, we have assembled instruments that are coming off the cleanroom production line ready for testing with our capital system scheduled to be completed later this week. The excitement internally is palpable. We eagerly look forward to proving out the value of our V1.0 system in the clinic later this year.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

A huge thanks to our dedicated team for their hard work and commitment and to our investors and other stakeholders for their continued support. Thank you to everyone who joined the call today. We appreciate your support and look forward to updating you on our continued progress. With that, Cameron, we're ready for Questo.

Operator

Thank you. We will now begin the question and answer session. The first question is from the line of Ryan Zimmerman with BTIG. You may proceed.

Ryan Zimmerman
Managing Director & Medical Technology Analyst at BTIG

Good afternoon. Thanks for taking my questions. Can you hear me okay, Adam?

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Yes, I can hear you.

Ryan Zimmerman
Managing Director & Medical Technology Analyst at BTIG

Okay, cool. Maybe just on the supplier dynamic, just wanted to understand what specifically is being held up And how is that impacting your ability to manufacture specifically systems for the clinical trial? And if you could talk about kind of what it does or doesn't do for your clinical trial activities this year? Start there.

Randy Clark
Randy Clark
President at Vicarious Surgical

Yes. I'll happy to jump in, Ryan, and then I'll see if Adam has any comments to add as well. But I'd say within our supply chain, we encountered material procurement challenges with a few key suppliers. This led to delays in component deliverables, which gated our build. Just to provide an example, one of our partners' sub tier suppliers had unforeseen financial issues creating a cascading effect and disrupting the flow of essential materials.

Randy Clark
Randy Clark
President at Vicarious Surgical

So, cascading effect and disrupting the flow of essential materials. So these delayed gated items directly hindered our manufacturing progress as several of these components were referred we refer to them as golden screws or critical parts that we need to complete production. As Adam indicated, our team literally at all levels did a great job in escalating with these suppliers and in leveraging our other suppliers and internal resources to minimize the impact to our time line. The good news is because I wanted to per the beginning part of your question, we currently have no gated items and have resumed capital and disposable production.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

I'll

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

just kind of come on top of it here and say that one positive of this is that we've been able to flush out every one of these challenges during this earlier build for all the essential performance and safety and can use all of those learnings and already are in the next build for the clinical.

Ryan Zimmerman
Managing Director & Medical Technology Analyst at BTIG

Okay. And so I guess that dovetails into the next question. So when do you anticipate I know you're narrowing down the sites now. When do you anticipate the clinical trial beginning? Because I think we kind of assumed maybe midyear this year.

Ryan Zimmerman
Managing Director & Medical Technology Analyst at BTIG

Is that still the plan? And then what as you go through the IRB process and at some of these sites, as you talk to the clinical sites, what kind of questions are they asking? What's their comfort level with the system as you kind of get rolling here to move into this clinical stage?

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Yes. It's a good question. So, first, I'll say that it's going to be later in the year that we're going to be doing our first patients. And just as a reminder, these will be outside of the pivotal. And then as quickly as we can after that, we'll kick off the pivotal, but leaving room for us to have any necessary changes, that we need, especially to the clinical protocol and trial protocol.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

As far as feedback from the site, it's a great question. The feedback from the site has been, first of all, generally incredibly excited and engaged. I think these sites, especially outside The U. S. Countries, are eagerly looking forward to not only getting to try our system in a clinical setting, but also have been talking about our plans for in country approvals as well, even while our first approval will be in The U.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

S. They want to be able to buy and use these, which is incredibly exciting for us to hear. And I'll say that I personally visited a number of these sites and the engagement and reception has been incredible.

Ryan Zimmerman
Managing Director & Medical Technology Analyst at BTIG

Okay. I'll hop back in queue. Thanks guys.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Thanks for the question.

Operator

The next question is from the line of Adam Master with Piper Sandler. You may proceed.

Adam Maeder
Adam Maeder
Senior Research Analyst at Piper Sandler Companies

Hey, Adam, Randy, Kate, thanks for taking the questions and congrats on the progress in one point zero integration. Just a couple to follow on here to Ryan's line of questioning. So I guess I just wanted to make sure I'm thinking about this right in terms of supply chain. It sounds like you had some dating instances that were impacting supply chain. That's now largely behind you.

Adam Maeder
Adam Maeder
Senior Research Analyst at Piper Sandler Companies

Did I hear that correct? But still, the result of that is starting the first in human later in 2025. Is that a fair characterization?

Randy Clark
Randy Clark
President at Vicarious Surgical

Yes, absolutely.

Adam Maeder
Adam Maeder
Senior Research Analyst at Piper Sandler Companies

Okay. Okay, perfect. And I guess just in terms of the dossier submission, are you able to kind of put any timing around that when we should expect you guys to submit the dossier?

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Yes. It will be somewhere right around the middle of this year. So that makes the frankly the first patient timing usually takes a few months to approve. And following that approval, we're going to, as quickly as humanly possible, start those cases.

Adam Maeder
Adam Maeder
Senior Research Analyst at Piper Sandler Companies

Okay. Fantastic. Thank you for that. And just for the follow-up, I guess maybe I'd love to hear just a little bit more about, the version one point zero integration, exactly kind of what that exercise entailed and what that means kind of in the grand scheme of things, number of cadaver procedures, who is driving the machine, does this mean that you have kind of officially design locked? Just would love to hear a little bit more about kind of that exercise and, the confidence that gives you going forward in 2025.

Adam Maeder
Adam Maeder
Senior Research Analyst at Piper Sandler Companies

Thank you.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Yes. So true kind of final design lock will come after all the preliminary testing and all the essential performance and safety. The process was a handful of cadavers and a large number of bench tests through a series that essentially allowed us to gain confidence in the system, know if there were any changes or tweaks that we wanted to make as we ramp up manufacturing in order to do all of this testing. So, I'd say the results were gaining a ton of confidence in the reliability of the systems, especially if the disposable instruments were very good, especially compared to previous builds and had cost and goods improvements as well that we brought in. So I'd say overall, it's something that we're really excited about.

Adam Maeder
Adam Maeder
Senior Research Analyst at Piper Sandler Companies

Thanks, Adam.

Operator

The next question is from the line of Josh Jennings with Cowen. You may proceed.

Josh Jennings
Managing Director at TD Cowen

Hi, good afternoon. Thanks for taking the questions. Nice to hear about all the progress. And one is just ask about the CADABRA lab results and the success that you reported. I mean, where eventual hernia maneuvers performed in the catheter lab?

Josh Jennings
Managing Director at TD Cowen

Or any other details you can just share and how important those results are in terms of this future submission in the Ministry of Health and moving forward in the clinical moving forward into the clinical trial?

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Yeah. So, these cadaver labs are performed by Doctor. Belayanski and, and Doctor. Barry Green, our Chief Medical Officer. And they were to perform, absolutely to perform dental hernia repairs, excuse me, repairs with both defects closure and mesh implantation.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

And overall, they, you know, certainly the initial tests are not without some hiccups. But we were incredibly impressed, especially how smoothly mesh fixation went and the ability to sew all the way around that mesh in multiple quadrants in a very short amount of time. So, it's something that we're all incredibly excited and proud

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

of.

Josh Jennings
Managing Director at TD Cowen

Excellent. And just on the clinical trial design and when that gets locked in, Any updates there just in terms of how many patients are expected? Are there any changes to your outlook in terms of discussion recent discussion with the FDA or any updates?

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Yes. So, we've done multiple presubmissions with the FDA leveraging the Safer Technologies program that we're a part of. And they've been very collaborative with us. So, we've gone through full detailed trial design. You know, as far as when it truly gets locked and finalized, it'll be after these first patients, which is a big chunk of the point of them, is to be able to, you know, evaluate outside of a clinical trial.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Of course, you still have to report anything, but it's not evaluated as part of the actual submission package, which gives us the flexibility to make changes after our first clinical patients and before the first pivotal trial patients.

Josh Jennings
Managing Director at TD Cowen

Great. And I guess lastly, I think you spoke about the need to build inventory in front of the clinical trial. Maybe can you just help us quantify kind of that the inventory build and how challenging or straightforward that process is? Thanks for taking all the questions.

Randy Clark
Randy Clark
President at Vicarious Surgical

Yes, happy to jump in there.

Randy Clark
Randy Clark
President at Vicarious Surgical

And just to reiterate some of the prior remarks as well, again, our teams did a great job in escalating the procurement challenges that we spoke to, leveraging our internal capabilities. And again, want to reiterate at this point in time, we don't have any data component. So we have really focused on scaling up our testing inventory and have literally finished instruments coming off of our clean room lines. As Adam mentioned as well, our first unit of surgeon console and patient console are expected to be completed at the end of this week. And for our testing and our first clinical patient, you know, I believe we stated previously, but just to reiterate, we're anticipating Boeing needing a few capital systems and then larger amounts of the instruments correlated to that tech submission or technical dossier as well.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

And if

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

I can come on top just because it's I mean, this has been one of the most exciting things internally for us that coming and seeing the clean room and instruments being manufactured in quantities and coming off the line, being packaged, ready for sterilization and the capital equipment can tilt up with all of cosmetic covers, all of the internal wiring. It's everything is coming together. It is the single most exciting time that I've ever had in this company.

Josh Jennings
Managing Director at TD Cowen

That's good to hear. Thanks for all the answers. Appreciate it.

Operator

There are currently no questions registered. So as a brief reminder, it is star one to ask a question. And there are no further questions waiting at this time. I would like to pass the conference back to the management team for any closing remarks.

Adam Sachs
Adam Sachs
Co-Founder, CEO & Director at Vicarious Surgical

Yes. I think, with that, I'd just like to say thank you so much to everybody. Thank you, Cameron, for being the operator on this call. And with that, we can end.

Operator

That concludes the Vicarious Surgical twenty twenty four fourth quarter and full year earnings call. Thank you for your participation and enjoy the rest of your day.

Executives
    • Kaitlyn Brosco
      Kaitlyn Brosco
      Director, Investor Relations
    • Adam Sachs
      Adam Sachs
      Co-Founder, CEO & Director
    • Randy Clark
      Randy Clark
      President
Analysts

Key Takeaways

  • Successful Version 1.0 system integration demonstrated in cadaveric preclinical settings, validating the platform’s ability to perform ventral hernia repairs through a single small incision with 13 degrees of freedom.
  • Expanded commercial partnerships with top U.S. academic health networks—LSU Health New Orleans, Temple Health, and University of Illinois Health—to support clinical evaluations, training protocols, and real-world system validation.
  • Established a robust, scalable manufacturing foundation by streamlining internal capabilities and onboarding key contract partners, overcoming supply chain gating issues to resume capital and disposable production.
  • Advanced regulatory preparations by selecting international clinical sites, securing IEC approvals, and targeting mid-2025 Ministry of Health technical dossier submission, with first in-human cases expected late 2025 and de novo submission in late 2026.
  • Demonstrated financial discipline in 2024, cutting operating expenses 17% year-over-year, achieving a $49 M cash burn (versus $50 M guidance), and ending the year with approximately $49 M in cash, cash equivalents, and short-term investments.
AI Generated. May Contain Errors.
Earnings Conference Call
Vicarious Surgical Q4 2024
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