3/4/2024

speaker
Matt
Conference Operator

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.

speaker
Caitlin Brosco
Director of Investor Relations, Vicarious Surgical

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.

speaker
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.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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