Vicarious Surgical Inc. Q3 FY2024 earnings call

Key Points

• Made meaningful progress toward delivering the first version of the single-port platform, with weeks away from year-end cadaver lab integration for V1.0 system.
• Post-cadaver lab, focus shifts to verification, validation, and manufacturing for testing. Anticipate treating first clinical patient in less than one year after successful testing.
• Clinical and regulatory team preparing OUS clinical sites for first patient and pivotal trial, with sites narrowed down to a select few within the same country.
• Third quarter operating expenses: total operating expenses $17.8M (down 17% y-o-y), R&D $10.8M, G&A $5.7M, sales and marketing $1.2M. Adjusted net loss $17M, GAAP net loss $17.1M.
• Ended third quarter with $61M in cash, cash equivalents, and short-term investments, cash burn $12M for the quarter, on track for full-year $50M cash burn.

No distinct product segments were discussed. Instead, the company focused on progress in developing its single-port surgical platform. In the third quarter, total operating expenses fell 17% year-over-year to $17.8 million. R&D expenses were $10.8 million, general and administrative expenses were $5.7 million, and sales and marketing expenses were $1.2 million. Cash position at the end of the quarter was $61 million in cash, cash equivalents, and short-term investments, with a cash burn of approximately $12 million for the quarter, on track for the full-year 2024 cash burn of roughly $50 million.

Forward-Looking Statements

• Closing out 2024 by completing integration of Version 1.0 System. Anticipate treating first clinical patient in less than one year after successful verification and validation testing.
• Projected cash burn for 2025 expected to be in the ballpark of 2024 spending, with cash runway extending through 2026.

Risks

• Forward-looking statements involve material risks and uncertainties, including those related to obtaining regulatory approval, operating trends, financial performance, expense management, market opportunity, and commercialization. These could cause actual results to differ from projections, as detailed in SEC filings such as Form 10-K and Form 10-Q.

Q: About the first clinical patient and the pivotal trial timeline, what's the expected timeframe?

A: Adam Sachs stated they'll follow the first clinical patient quickly to validate and adjust the protocol for the pivotal trial.

Q: What criteria were used for selecting OUS clinical sites?

A: Adam Sachs mentioned criteria related to regulatory pathway, timeline, and patient volume.

Q: What items remain to be addressed in the integration of Version 1.0 System?

A: Adam Sachs said the finalization involves shaking out bugs and bringing everything together through cadaver and animal labs to ensure functionality.

Q: How many patients are expected in the first-in-human study and what does verification and validation entail?

A: Adam Sachs said the first-in-human study could be up to 5 patients. Verification includes bench testing to meet system requirements, and validation checks user needs to ensure the device delivers on user requirements.

Q: What's the outlook for cash burn in 2025 and cash runway?

A: Bill Kelly said cash burn for 2025 is expected to be in the ballpark of 2024 spending, with cash runway extending through 2026.