Good afternoon. Thank you for joining Vicarious Surgical's earnings call for the fourth quarter and full year of 2024. My name is Cameron, and I will be your moderator today. All lines have been muted during the presentation, but there will be a chance for questions at the end. Now, I would like to hand over the call to your host, Kaitlyn Brosco, Director of Investor Relations. You may proceed.

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 December 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. Any statements contained in this call not related 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, 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 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 and is accurate only as of the live broadcast today, March 17, 2025. Vicarious Surgical disclaims any intention or publication 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.

Thanks, Kate. Good morning, everyone, and good afternoon, everyone, and welcome to our fourth quarter and full year 2024 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. Throughout the past year, we achieved several 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 '25 marks our transition into a clinical-stage company. Our most anticipated milestone in 2024 was the successful completion of our Version 1.0 System integration. As you may recall from our last earnings call, we were just weeks away from our year-end cadaveric lab, a critical event that would signify the achievement of the key development milestones. We're thrilled to share that the cadaveric lab was a 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 validates the hard work and dedication of our entire team. The Version 1.0 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 complex instrument triangulation and providing surgeons with 13 degrees of freedom per instrument for advanced dexterity in 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, Version 1.0 lays the foundation for future advanced AI features that leverage sensing technologies such as multimodal fluorescent labeling and LiDAR adopted 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. In 2024, we continue to expand our community of top-tier hospital system partners. We announced an agreement with Louisiana's premier academic health institutions, LSU Health New Orleans, and towards the end of the year, we officially inked partnerships with two other major academic health networks, 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 hospitals, 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 protocols, equipping healthcare professionals to effectively utilize our technology once on the 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 this important milestone, our regulatory and clinical teams 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 safety requirements such as biocompatibility, sterility, electrical safety, functional testing and supporting cadaveric and animal data. Now that the Version 1.0 system integration is complete, our development 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. 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 in certain redundancies to mitigate potential disruptions. We prioritized 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 months of this year, we've also encountered some instances of delayed 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 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 are focused on controlling what we can, mitigating risks wherever 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 transactions, most recently at Entero Therapeutics and Kiora Pharmaceuticals. We're thrilled to welcome Sarah to the Vicarious Surgical team. For today, however, Randy will review our 2024 financials. I'll now turn the call over to him.

Thank you, Adam, and jumping into the financials, starting with total operating expenses for the full year 2024. They were $66.6 million, down 17% year-over-year. R&D expenses for the full year 2024 were $40.2 million, down from $47.6 million in 2023. General and administrative expenses totaled $21.9 million in the full year 2024, down from $26.9 million in 2023. In full year 2024, sales and marketing expenses were $4.5 million compared to $6.2 million in the prior year. Adjusted net loss for the full year 2024 was $63.3 million, equating to an adjusted net loss of $10.75 per share as compared to an adjusted net loss of $76.3 million or an adjusted net loss of $15.67 per share for the prior year. GAAP net loss for the full year was $63.2 million, equating to a net loss of $10.74 per share as compared to a GAAP net loss of $71.1 million or $14.60 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 million, achieving a favorable variance from our original guidance of approximately $50 million. This resulted in a year-end balance of approximately $49 million in cash, cash equivalents, and short-term investments, underscoring our commitment to financial discipline. Looking ahead to 2025, we again anticipate a cash burn of approximately $50 million and will 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 made throughout 2024. We successfully integrated our Version 1.0 system, built a robust supply chain and manufacturing foundation, forged 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 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 look forward to proving out the value of our V1.0 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. And with that, Cameron, we're ready for questions.

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

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

Yeah, I can hear you.

Okay, cool. Maybe just on the supplier dynamic, I 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.

Yes, I'm happy to jump in. Within our supply chain, we faced significant procurement challenges with a few key suppliers, which caused delays in receiving components and impacted our manufacturing. For instance, one of our partner's sub-tier suppliers had unexpected financial issues, leading to a knock-on effect that disrupted the supply of essential materials. These delayed components were critical parts necessary for completing production. As Adam mentioned, our team did an excellent job at all levels in addressing these issues with our suppliers and utilized other resources to mitigate the impact on our timeline. Fortunately, we currently have no delayed items and have restarted both capital and disposable production.

I want to highlight that one positive aspect is that we have effectively addressed all the challenges during the initial build regarding performance and safety. We are using those insights in the next build for the clinical phase.

Okay. I guess that leads into the next question. When do you expect the clinical trial to start? We originally thought it might be around mid-year this year. Is that still the timeline? Also, as you go through the IRB process and engage with some of these sites, what questions are they asking? How comfortable are they with the system as you begin this clinical phase?

Yes, a good question. So first, I'll say that it's going to be later in the year that we are 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. 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 in 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.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.

Okay, I’ll hop back in queue. Thanks guys.

Thanks for your question.

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

Hi, Adam, Randy, Kate. Thanks for taking the questions and congrats on the progress in 1.0 integration. Just a couple of follow-ons 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 the supply chain. It sounds like you had some dating 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 any timing around that when we should expect you guys to submit the dossier?

Yes, it will be around the middle of this year. The approval process for the first patient typically takes a few months, and following that approval, we will begin those cases as quickly as possible.

Okay. Fantastic. Thank you for that. And just for the follow-up, I guess maybe I would love to hear just a little bit more about the Version 1.0 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 lock? Just would love to hear a little bit more about kind of that exercise and the confidence that gives you going forward in 2025. Thank you.

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 we are gaining a ton of confidence in the reliability of the systems, especially at the disposable instruments were very good, especially as compared to creative builds and had cost of goods improvements as well that we brought in. So I'd say, overall, it is 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. It's great to hear about all the progress. I wanted to ask about the Cadaver Lab results and the success you reported. Were ventral hernia maneuvers conducted in the Cadaver Lab? Can you share any additional details and explain how significant these results are for future submissions to the Ministry of Health and moving forward into the clinical trial?

Yes. The cadaver labs were conducted by Dr. Bellinski and Dr. Barry Greene, our Chief Medical Officer, focusing on performing ventral hernia repairs that involved both defect closure and mesh implantation. Overall, while the initial tests had some challenges, we were very impressed with how smoothly the mesh fixation process went and the ability to sell around the mesh in multiple quadrants in a very short period. We are all extremely excited and proud of these results.

Excellent. Do you have any updates on the clinical trial design, such as the expected number of patients and any recent discussions with the FDA that might change your outlook?

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

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 we are straightforward that process is? Thanks for taking all the questions.

Yes. Happy to jump in there. And just to reiterate some of the prior remarks, again, our team did a great job in escalating the procurement challenges that we spoke to, leveraging our internal capabilities. And again, I want to reiterate at this point in time, we don't have any gated components. 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 patients, I believe we stated previously, but just to reiterate, we are anticipating only needing a few capital systems and then larger amounts of the instruments correlated to that technical submission or technical dossier as well.

This has been one of the most exciting experiences for us, seeing the clean room where instruments are being manufactured in large quantities, coming off the line, being packaged, and ready for sterilization. The capital equipment can accommodate all of the cosmetic covers and internal wiring. Everything is coming together, and it is the most thrilling time I've ever had in this company.

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

There are no further questions at this time. I would like to hand the conference back to the management team for any closing remarks.

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 2024 fourth quarter and full year earnings call. Thank you for your participation, and enjoy the rest of your day.