Vicarious Surgical Inc.

All participants are in a listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I will now have to turn the call over to Caitlin Brosco with Vicarious Surgical for a few introductory comments.

Thanks, Matt, and thank you all for participating in today's call. Earlier today, Vicarious Surgical released financial results for the three months and full year ended December 31st, 2023. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call that includes forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or prediction 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, are operating trends in 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 would 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 risk 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 4, 2024. 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. With that, I will turn the call over to Adam Sachs, Chief Executive Officer.

Thanks, Kate. Thank you, everyone, for joining us. 2023 was a meaningful year for Vicarious Surgical. We began the process of transforming our Beta 2 surgical system into our version 1.0 product. With collaboration from our surgeon and hospital system partners, we meticulously shaped the design of our V1.0 system and then turned focus on subsystem build-out and integration in preparation for verification and validation testing. In our V1.0 system design, we incorporated enhancements for further refined motion profile and higher image quality with increased system safety. All with the goal of delivering the best products possible for surgeons and hospitals. Considering that only a small fraction, approximately 4% of soft tissue surgeries currently employ robotics, there's a substantial opportunity to further alleviate the robotics value proposition for patients, surgeons, and hospitals. Our distinctive system architecture, founded on proprietary decoupled actuator technology, not only enables superior capabilities, but also has the potential to streamline training, enhance OR workflow, and to offer compelling economic advantages. Additionally, our architecture facilitates best-in-class visualization, sensing, and data collection, all crucial for deploying and integrating automated procedural safeguards into robotic-assisted procedures. We are confident that our innovative approach to surgical robotics, along with its array of distinctive advantages, is the cornerstone to unleashing the complete potential of this field. Throughout 2023, as we continue to press forward on product development, we made meaningful progress, particularly in the build of each individual subsystem. However, we also encountered external headwinds and met certain integration hurdles. Continuously challenging macroeconomic conditions throughout the year created an opaque market outlook with increased capital costs. Consequently, last year, we made the difficult decision to downsize our team twice and reduce future planned expenditures, prioritizing capital efficiency and ensuring our business was better positioned to navigate such conditions. Furthermore, in the latter part of the year, as we began the V1 Plano subsystem integration, we identified certain software and hardware components requiring additional development efforts to ensure system compliance, reliability, and safety ahead of entering formal verification and validation testing. And while the culmination of these headwinds translated into an extension of timelines, I am incredibly proud of how our team adapted and what we were able to achieve nonetheless. To that end, I'd like to touch upon some of our wins in 2023 and highlight the milestones we expect to achieve in the quarters ahead. First, we were successful in expanding our foundational partnership with leading hospital systems as we collect feedback on the vicarious surgical offering and lay the groundwork for commercialization. In the third quarter, we announced our partnership with Intermountain Health, a system of 33 hospitals and 385 clinics spread across the Mountain West region of the United States. This partnership adds to our existing relationships with three of the top healthcare networks in the country, HCA Healthcare, University Hospitals and Pittsburgh creates. Through tapping into their wealth of expertise, these collaborations afford us exclusive insights instrumental in refining our products to precisely match the surgeon and hospital needs to deliver the best possible care for patients, thus ensuring our readiness for commercial success. Second, we raise $47 million to an equity follower offering that meaningfully bolstered our balance sheet to support development, clinical, and regulatory efforts in the quarters ahead. And finally, through an extensive series of pre-submission meetings with the FDA, we received regulatory clarity. Not only did we receive reassurance that are on our path to market, but we were also pleased with the agency's suggestion to include clinical data for patients outside the United States. in our de novo submission, as OUS clinical data collection will meaningfully facilitate our ability to enroll patients and complete procedures. Thanks to these achievements and our capacity to make the difficult but necessary decisions, we concluded 2023 with the completion of each individual subsystem built for our newly architected B1.0 system, the addition of another major hospital system partnership a clearly defined regulatory strategy, and a more resilient business structure supported by our strength and balance sheet. We are excited to drive our momentum into 2024 and execute on our objectives. Within the first month of this year, we made strides in subsystem integration, and today we are excited to affirm that we will conduct Catavera testing this spring as a means of evaluating our system ahead of final software and hardware refinement, and ultimately complete the integration of our V1.0 system this fall. I'd like to now turn to a few leadership developments. Earlier today, we filed an 8-K disclosing David Sika's retirement as chairman of the board. David has played a pivotal role in our company's accomplishments over the last four years. we'd like to extend our heartfelt gratitude to him for his guidance and support with david's departure we are evaluating our board composition and potential courses of action moreover i'm thrilled to start 2024 with the appointment of randy clark as president of vicarious surgical randy brings over 20 years of medical device industry experience with a track record of leadership and development manufacturing and commercialization of innovative solutions he most recently served as the global president of the health solutions business unit at flex and prior to that spent 15 years at olympus progressively assuming leadership roles across various business functions ultimately culminating in his role as president as we expected randy is already proving himself to be an invaluable leader and asset to vicarious surgical as we focus on achieving our 2024 milestone. Now, I will turn it over to Bill Kelly to review our financial performance.

Thank you, Adam. Throughout 2023, we proactively adjusted our planned spending to better align with the external environment. We implemented initiatives to streamline resources, optimize spending, and restructure the company for maximum efficiency. This included two rounds of downsizing and cost reduction which we expect to benefit our 2024 expense profile. As a result, total operating expenses for the full year 2023 were $80.7 million, essentially flat compared with the prior year. R&D expenditures for the full year 2023 were $47.6 million compared to $43.9 million in 2022. General and administrative expenses for the full year were $26.9 million down compared to $29.7 million in 2022, and full year 2023 sales and marketing expenses of $6.2 million were comparable to the prior year. Adjusted net loss for the full year was $76.3 million, equating to an adjusted net loss of 52 cents per share, as compared to an adjusted net loss of $78.8 million or an adjusted net loss of $0.65 per share for the prior year. GAAP net loss for the full year was $71.1 million, equating to a net loss of $0.49 per share. For a reconciliation of all non-GAAP measures to GAAP, please review our earnings press release. We ended 2023 with approximately $98 million of cash, cash equivalent, and short-term investments on our balance sheet. As a result of our disciplined spending during the year, we are pleased to have executed on our full year 2023 cash burn guidance with a burn rate of $63.4 million for the year in line with our original full year and updated Q3 guidance. Turning to our 2024 outlook, we expect cash burn of approximately $50 million for the full year in line with our initially provided 2024 cash flow guidance of 40 to 55 million dollars with the resources at our disposal and our disciplined fiscal approach we are confident in our ability to execute on our spring cadaver lab integrate our version 1.0 system by this fall and achieve other important milestones we look forward to updating you as we progress with our business initiatives in the coming quarters with that i will turn the call back to adam adam

Thank you, Bill. 2023 brought about meaningful milestones and strategic decisions that firmly positioned Viteri Surgical to achieve our 2020 core objectives and advance our long-term vision of delivering innovative surgical robotic solutions to patients, surgeons, and hospitals. We maintain steadfast confidence in the potential of our unique technology and the opportunity to generate substantial value for all stakeholders. I'd also like to express my gratitude to all vicarious surgical employees for their unwavering hard work and dedication. I equally anticipate our continued collaboration and progress throughout 2024. Thank you, everybody, for joining today's call. We're now happy to take any questions.

If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason you'd like to remove that question, please press star followed by two. Again, to ask a question, press star one. As a reminder, if you're using a speakerphone, please remember to pick up your handset before asking your question. We will pause here briefly as questions are registered. The first question is from the line of Ryan Zimmerman with BTIG. Your line is now open.

Good afternoon. Thanks for taking my question. Maybe just to start on the milestones, Adam and Bill, what do you expect to get out of the cadaver lab in the spring? How much can you use for your regulatory submission? And just kind of the expectations there. And then once you get the V1.0 established, again, kind of what's the process from A to B in terms of using that to then get to the next step towards regulatory submission.

So thanks so much for the questions, Ryan. First of all, we're really pleased with the progress we've made so far on the V1.0 system. The spring cadaver lab is really about testing that fully integrated V1.0 system. Overall, the purpose of the V1.0 system and the cadaver lab is to prove out that all of that functionality that surgeons and hospitals really love that was in the Beta 2 prototype is now in our B1.0 product, works as effectively, and all of it is being conducted and documented appropriately to be a part of our process for the regulatory system. Then the next step after that, I think, was your second question. And that really is about taking any of the challenges that we unearthed during this cadaveric process, as well as any bugs resolving those over the rest of the spring, the summer, and the fall into our final V1.0 system.

Okay. Got it. Thank you. Well, I guess just to follow up on that, so just to be clear then, the V1.0, but is the V1.0 what you're going to the agency with, or do you expect to have a V2.0? I just want to make sure I'm clear about kind of that pathway to clearance.

It's a fair question. So the V1.0 system is what we intend to take to the agency. But, you know, I do want to set expectations that there's a reason that it's not finalized this spring. I do expect to have some things that are going to be tweaked or adjusted overall over the course of the summer and the fall. And we are on track for the fall milestone.

Okay. I'll hop back in queue and probably some others. I want to ask questions. And if I have others, I'll hop back in. Thanks.

Sounds good.

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There are no additional questions waiting at this time, so I will now end the call.

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