Vicarious Surgical Inc. Price & Performance (RBOT)

With me on today's call is Adam Fox, cofounder and chief executive officer and Randy Clark, company president. Today, after market closed by Carrie Surgical released financial results for the three months and full year ended 12/31/2024. Copy of the press release is available on the company website. 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, accretion of future events, results, or performance are forward looking statements. All forward looking statements, without limitation, those relating to obtaining approval for the Vicarious Surgical System, and timing for any such approval our operating trends, 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 could 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 k and Form 10 Q. This conference call contains time sensitive information, is accurate only as of the live broadcast.

Today. 03/17/2025. Vicarious Surgical disclaims any intent 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, otherwise. I'll now hand the call over to Adam for prepared remarks. Thanks, Kate. Good morning, everyone, and welcome excuse me, good afternoon, everyone, and welcome to our fourth quarter and full year 2024 earnings call. 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. 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 of our version one point o system integration. As you may recall from our last earnings call, we were just weeks away for our year end cadaver lab, a critical event that would signify the achievement of this key development milestone.

We're thrilled to share the Canaveralab with the success demonstrating the functionality and performance of our V1.0 system in a cadaveric preclinical setting. This achievement represents a significant step forward in bringing our innovative robotic surgery platform to market and validate the hard work and dedication of our entire team. The version one point o 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 its 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 joint eliminating the need for complexity instrument triangulation, and providing surgeons with 13 degrees of freedom for instruments for advanced dexterity and near 360 degree visualization and anatomical access. 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, Virgin one point o 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. Is our unique approach to surgical robotics that has garnered significant interest from leading US hospital 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, company 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 through its network of hospital, clinics, and research institutions. 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 protocol equipping health care 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. In preparation for the important milestone, our regulatory and clinical team dedicated 2024 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 ethics 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 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 arm, camera, and capital equipment required to supply the rigorous testing schedule leading to our Ministry of Health technical dossier submission.

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 prioritized establishing relationships with trusted partners, who share our commitment to quality and precision, ensuring we 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 buildup. 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. 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 Sarah brings decades of financial leadership, including significant experience in capital markets, and driving growth through fundraising and strategic corporate transactions. Most recently, at Entero Therapeutics and Kira Pharmaceuticals. We're thrilled to welcome Sarah to the Vicarious Surgical team. For today, however, Randy will review our 2024 financial I'll now turn the call over to him.

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. 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 on 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 $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 imbalance of approximately $49,000,000 in [indiscernible] 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.

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?

Thanks, Randy. I'd like to close out by reiterating the significant progress we've made throughout 2024. We successfully integrated our version one point o 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've assembled instruments that are coming off the clean room production line ready for testing. With our capital system scheduled to be completed later this week. The excitement internally is palpable. We eagerly eagerly look forward to providing excuse me, to proving out the value of our v one point o system in the clinic later this year. 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 questions.

Thank you. We will now begin the question and answer session. If you would like to ask a question, please press followed by one on your telephone keypad. If for any reason you would like to remove that question, please press followed by 2. Again, to ask a question, press one. And as a reminder, if you are using a speakerphone, please remember to pick up your handset before asking a question. [indiscernible] is from the line of Ryan Zimmerman with BTIG. May proceed.

Good afternoon. Thanks for taking my questions.

Can you hear me okay?

Adam? Yeah. We can hear you.

Okay. Cool.

Maybe just know, on the supplier dynamic, just wanna understand what specifically, [indiscernible] being held up, and how 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.

Yeah. I'll happy to jump in, Ryan, and then I'll I'll 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 bill. Just to provide an example, one of our partners' sub tier suppliers had unforeseen financial issues creating a cash cascading effect in disrupting the flow of essential materials. So, you know, these delayed gated items directly hindered our manufacturing progress as several of these components were, you know, 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 timeline. The good news is because I wanted to you know, per the the beginning part of your question, we we currently have no gated items and have resumed capital and disposable production. [indiscernible] I'll just kinda come on top of of it here and say that, you know, one one positive of this is that we've been able to to flush out every 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 for the clinical.

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

Yeah. It's a a good question. So first, you know, I'll that it's gonna be, you know, later in the year. That we're gonna be doing our our first patients. And, you know, just as a reminder, these these will be outside of the pivotal, and then know, as quickly as we can after that, we'll we'll kick off the pivotal, but leaving room for you know, us to have any necessary changes we need, especially to the clinical protocol and trial protocol. As far as feedback from the site, it's The the feedback from the site has been, first of all, generally in incredibly excited and engaged. I think these these sites, especially in outside the The US countries, are 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 approval as well, even while our first approval will be in The US. You know, they they want to be able to buy and use these, which is incredibly exciting for us to hear. And I'll I'll say that, you know, I personally visited a number of these sites, and, the engagement and and reception has been incredible.

Okay.

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

Thanks for the question.

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

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

Yes. Absolutely.

Okay. Okay. Perfect.

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

Yeah. It'll be somewhere right around the the middle of this year. So, you know, that that makes the, frankly, the first patient timing. It usually takes a few months to approve, and yeah, following that approval, we're gonna, as quickly as humanly possible, start those, those cases Okay. Fantastic.

Thank you for that. And just for the the follow-up, I guess maybe I'd love to hear just a little bit more about you know, the the version one point o integration exactly kind of what that exercise entailed and and what that means kind of in the know, the grand scheme of things. You know, number of cadaver procedures, who was 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 and, the confidence that gives you going forward in '25. Thank you.

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

Thanks, Adam.

The next question is from the line of Josh Jennings with Cowen. You may proceed. Hi, good afternoon. Thanks.

For taking the questions. Nice to hear about all the progress and one is just to ask about the cadaver lab results and and the success that you reported. I mean, should is were ventral hernia maneuvers performed in the TAVR lab, or any other details you can just share and and how important those results are in terms of this future submission in the Ministry of Health and moving forward in the clinic moving forward into the clinical trial.

Yeah. So and these cadaver labs are performed by doctor Belanski and and know, 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. And, overall, they you know, it's certainly, the initial tests are not not without some hiccups, but we were incredibly impressed, how smoothly mesh fixation went and the ability to sell all the way around that mesh in multiple quadrants in very short amount of time. So it's it's something that we're all incredibly excited and proud of.

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 to your outlook in terms of discussion recent discussion with the FDA or any updates?

Yeah. So we've we've done multiple pre submissions with the FDA, leveraging the safer technologies program that that we're a part of. And they've they've been, you know, 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 it'll be after these first patients, which is is a big chunk of the the point of them is to be able to you know, evaluate outside of a clinical trial, of course, She starts to report anything, but it not evaluated as part of the act submission package, which gives us the the flexibility to make changes after our first clinical patients and before the first pivotal trial patient. Great. And then just lastly, I think you spoke about the need to build inventory in front of the clinical trial. Maybe you can just help us quantify kind of that that the inventory build and and how challenging or or straightforward that process is. Thanks for taking all the questions. Yeah. Happy to jump in there. And just to reiterate some of the, prior as well. Again, our teams did a great job in escalating the procurement challenges that we spoke to, leveraging our internal capabilities.

And, again, I want to reiterate this point in time, you know, we don't have any gated 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, you know, our first unit of surgeon console and patient console are expected to be completed at at at the end of this week. And for our testing and our first clinical patient, you know, I believe we've stated previously, but just to reiterate here, we're going needing a few capital systems. And then larger amounts of the the instruments correlated to that submission or technical dossier. As well. And and if I can come on top just because it's I mean, this has been one of the most exciting things internally for us. It's you know, coming and seeing the clean room and instrument being manufactured in in, you know, quantities and coming off the line, being, you know, packaged, ready for sterilization. And the capital equipment can tilt up with all 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.

That's good to hear. Thanks for the all the answers. Appreciate it. 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 the management team for any closing remarks.

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