Vicarious Surgical Q4 2023 Earnings Call Transcript

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Provided by Quartr
March 4, 2024

There are 5 speakers on the call.

Operator

Good afternoon, and welcome to Vicarious Surgical's 4th Quarter 2023 Earnings Conference Call. My name is Matt, and I'll be your operator for today's call. At this time, 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.

Operator

I would now like to turn the call over to Kaitlyn Brosco with Vicarious Surgical for a few introductory comments.

Speaker 1

Thanks, Matt, and thank you all for participating in today's call. Earlier today, Vicarious Surgical released financial results for the 3 months and full year ended December 31, 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 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 or prediction of future events, results or performance are forward looking statements.

Speaker 1

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 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 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. This conference call contains time sensitive information and is accurate only as of the live broadcast today, March 4, 2024.

Speaker 1

Vicari 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 Sacks, Chief Executive Officer.

Speaker 2

Thanks, Kate, and 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.

Speaker 2

Considering that only a small fraction, approximately 4% of soft tissue surgery is currently in polyrobotics, 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.

Speaker 2

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 extensive time line, I am incredibly proud of how our team adapted and what we were able to achieve nonetheless.

Speaker 2

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. 1st, we were successful in expanding our foundational partnership with leading hospital systems as we collect feedback on the VITERIA Surgical offering and laid the groundwork for commercialization. In the Q3, 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 3 of the top healthcare networks in the country, HCA Healthcare, University Hospitals and Pittsburgh CREATE. 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.

Speaker 2

2nd, we raised $47,000,000 to an equity follow our 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 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 from 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 this difficult but necessary decision, we concluded 2023 with the completion of each individual subsystem built for our newly architected V1.0 system, the addition of another major hospital system partnership, a clearly defined regulatory strategy and a more resilient business structure supported by our strengthened balance sheet. We are excited to drive our momentum into 2024 and execute on our objectives.

Speaker 2

Within the 1st month of this year, we made strides in subsystem integration. And today, we are excited to affirm that we will conduct cadaver 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 ks disclosing David Seika's retirement as Chairman of the Board. David has played a pivotal role in our company's accomplishments over the last 4 years, and we'd like to extend our heartfelt gratitude to him for his guidance and support.

Speaker 2

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.

Speaker 2

Now, I will turn it over to Bill Kelly to review our financial performance.

Speaker 3

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 2 rounds of downsizing and cost reductions, which we expect to benefit our 2024 expense profile. As a result, total operating expenses for the full year 2023 were $80,700,000 essentially flat compared with the prior year.

Speaker 3

R and D expenditures for the full year 2023 were $47,600,000 compared to $43,900,000 in 2022. General and administrative expenses for the full year were $26,900,000 down compared to $29,700,000 in 2022 and full year 2023 sales and marketing expenses of $6,200,000 were comparable to the prior year. Adjusted net loss for the full year was $76,300,000 equating to an adjusted net loss of 0 point dollars or an adjusted net loss of $0.65 per share for the prior year. GAAP net loss for the full year was $71,100,000 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.

Speaker 3

We ended 2023 with approximately $98,000,000 of cash, cash equivalents 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 $63,400,000 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 $50,000,000 for the full year, in line with our initially provided 2024 cash burn guidance of $40,000,000 to $55,000,000 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.

Speaker 3

Adam?

Speaker 2

Thank you, Bill. 2023 brought about meaningful milestones and strategic decisions that firmly positioned Cytere 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 eagerly anticipate our continued collaboration and progress throughout 2024.

Speaker 2

Thank you everybody for joining today's call. We're now happy to take any questions. Operator?

Operator

First question is from the line of Ryan Zimmerman with BTIG. Your line is now open.

Speaker 4

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?

Speaker 4

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?

Speaker 2

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 cadavarab is really about testing that fully integrated V1.0 system. Overall, the purpose of the V1.0 system in the cadaver lab is to prove out that all of that functionality that surgeons and hospitals really loved that was in the beta-two prototype is now in our V1.0 product, works as effectively and all of it is being conducted and documented appropriately to be part of our process for the regulatory system. Then the next step after that, I think was your second question.

Speaker 2

And that really is about taking any of the challenges that we unearthed during this catheveric process as well as any bugs resolving those over the rest of the spring, the summer and the fall into our final B1 plan of

Speaker 4

system. Okay. Got it. Thank you. And well, I guess just to follow-up on that.

Speaker 4

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.

Speaker 2

Yes. It's a fair question. So the V1.0 system is what we intend to take to the agency. But 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.

Speaker 4

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.

Speaker 2

Sounds good.

Operator

Thank you for your question. There are currently no further questions registered. There are no additional questions waiting at this time. So I will now end the call. Thank you for joining.

Operator

You may now disconnect your lines.

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Key Takeaways

  • Vicarious Surgical advanced its Beta 2 prototype into the V1.0 surgical system, completing individual subsystem builds and planning cadaver testing this spring with full integration targeted by this fall.
  • The company strengthened its clinical and commercial feedback loop by expanding partnerships with leading health networks, including Intermountain Health, HCA Healthcare, University Hospitals and Pittsburgh CREATE.
  • Vicarious Surgical raised $47 million in an equity offering, ended 2023 with approximately $98 million in cash and short‐term investments, and delivered a 2023 cash burn of $63.4 million with 2024 burn guidance of ~$50 million.
  • Through extensive FDA pre‐submission meetings, management secured regulatory clarity on its de novo pathway and received agency support for including outside‐the‐US clinical data in its submission.
  • The company implemented two rounds of downsizing and cost-reduction initiatives, keeping full-year 2023 operating expenses flat at $80.7 million and positioning for improved capital efficiency in 2024.
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Earnings Conference Call
Vicarious Surgical Q4 2023
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