Vicarious Surgical Inc

NYSE:RBOT

Earnings Call Analysis

Vicarious Surgical Targets V1.0 System Integration by Fall 2024

Vicarious Surgical made significant strides in 2023, transitioning their Beta 2 surgical system into the Version 1.0 product and securing notable partnerships for future commercialization. The innovative V1.0 system promises enhanced motion, image quality, and system safety, aiming to capitalize on the significant market potential in soft tissue surgeries. Despite encountering macroeconomic challenges and system integration hurdles, which necessitated downsizing and fiscal adjustments, the company retained its momentum, concluding the year with $98 million in cash and a strategic focus on product development and regulatory pursuit. For 2024, Vicarious Surgical is eyeing a disciplined cash burn of approximately $50 million, in anticipation of integrating their system and validating its efficacy through spring cadaver testing.

Vicarious Surgical's Year of Strategic Development and Progress

Despite facing external headwinds and integration challenges, Vicarious Surgical had a transformative year. The company not only refined its Version 1.0 surgical system with an eye towards superior capability and efficiency but also laid groundwork for its commercialization. Collaborations with key healthcare partners and successful fundraising efforts, including a $47 million equity raise, helped to strengthen the balance sheet and fuel future developments.

Maintaining Resilience Amid Macro Challenges

Vicarious Surgical encountered tough macroeconomic conditions, leading to downsizing and spending adjustments, ultimately maintaining an operationally resilient posture. The integration work for the Version 1.0 system identified software and hardware development needs to meet compliance standards, delaying timelines slightly but demonstrating adaptability and commitment to quality and safety.

Evolving Leadership and Regulatory Strategy

The company filed an 8-K acknowledging David Styka's retirement as Chairman and welcomed Randy Clark as the new President. With detailed regulatory strategies in place, they received positive feedback from the FDA, including the inclusion of clinical data from international sources, deemed beneficial for their de novo submission process for the Vicarious Surgical System.

Financial Performance and Outlook

Vicarious Surgical reported flat operating expenses year-over-year at $80.7 million for 2023, with an R&D increase offset by reductions in G&A. They closed the year with an adjusted net loss of $76.3 million and a GAAP net loss of $71.1 million, ending with approximately $98 million in cash and short-term investments. The disciplined cost management resulted in meeting the original and updated full-year cash burn guidance of $63.4 million. Looking ahead, Vicarious Surgical anticipates a cash burn of around $50 million for 2024, aligning with previous guidance and supporting milestones like conducting cadaver testing and integrating the Version 1.0 System.

Earnings Call Transcript 2023-Q4

[Operator]

Good afternoon, and welcome to Vicarious Surgical's Fourth Quarter 2023 Earnings Conference Call. My name is Matt, and I'll be your operator for today's call. [Operator Instructions] As a reminder, this call is being recorded for replay purposes.

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

[Kaitlyn Brosco, executive]

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 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 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-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.

[Adam Sachs, executive]

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 a 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 is 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 capability 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 sales 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 is better positioned to navigate such conditions.

Furthermore, in the latter part of the year, as we began the V1.0 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 process. And while the culmination of these headwinds translated into an extension of time line, 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 3 of the top health care networks in the country: HCA Healthcare, university hospitals and Pittsburgh CREATES. Through tapping into their wealth of expertise, these collaborations afford us exclusive insight instrumental in refining our products to precisely match the surgeon that hospital needs to deliver the best possible care for patients, thus ensuring our readiness for commercial success.

Second, we raised $47 million through an equity follow-on 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 presubmission meetings with the FDA, we received regulatory clarity. Not only did we receive reassurance that our -- on our path to market, but we were also pleased with the agency 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 build for our newly architected V1.0 System, the addition of another major hospital system partnerships of clearly defined regulatory strategies, 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.

Within the first month of this year, we made strides in subsystems integration. And today we are excited to affirm that we will conduct cadaver testing this spring as a mean 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 development. Earlier today, we filed an 8-K disclosing David Styka's retirement as Chairman of the Board. David 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. 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 in 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 an 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.

[William Kelly, executive]

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 $80.7 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 $0.52 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 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 $63.4 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 burn guidance of $40 million to $55 million. 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?

[Adam Sachs, executive]

Thank you, Bill. 2023 brought about meaningful milestones and strategic decisions that firmly positioned Vicarious 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.

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

[Operator]

[Operator Instructions] The first question is from the line of Ryan Zimmerman with BTIG.

[Ryan Zimmerman, analyst]

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 toward regulatory submission?

[Adam Sachs, executive]

So thanks so much for the questions, Ryan. First of all, we're really pleased with the progress we've made so far in 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 loved that was in the Beta 2 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 submission.

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.

[Ryan Zimmerman, analyst]

Okay. Got it. And well, I guess, just to follow up on that. So just to be clear then, the V1.0 -- 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.

[Adam Sachs, executive]

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.

[Operator]

There are currently no further questions registered. [Operator Instructions]

There are no additional questions waiting at this time. So I will now end the call. You may now disconnect your lines.