Vicarious Surgical (US:RBOT)2023-07-28 01:18Financial Data and Key Metrics Changes - Total operating expenses for Q2 2023 were $21.5 million, a 12% increase from $19.1 million in Q2 2022 [13] - GAAP net loss for Q2 2023 was $15.3 million, or $0.12 per share, compared to a net loss of $1.5 million, or $0.01 per share, in the same period last year [13] - Adjusted net loss for Q2 2023 was $20.4 million, equating to an adjusted net loss of $0.16 per share, compared to an adjusted net loss of $19.1 million, or $0.16 per share, for the same period in the prior year [14] - Cash, cash equivalents, and short-term investments at the end of Q2 were approximately $83 million, with a cash burn of $14.9 million [14] Business Line Data and Key Metrics Changes - R&D expenses for Q2 2023 were $12.7 million, compared to $10.1 million in the prior year [13] - General and administrative expenses were $7.1 million in Q2 2023, down from $7.8 million in Q2 2022 [13] - Sales and marketing expenses for Q2 2023 were $1.7 million, compared to $1.3 million in the prior year [13] Market Data and Key Metrics Changes - The company signed a fourth major U.S. Hospital System as a partner, bringing the total number of hospitals represented by partners to over 250 [6] Company Strategy and Development Direction - The company is advancing from design freeze towards manufacturing and testing of its Version 1.0 System, with plans to perform its first ventral hernia procedure in a patient mid-next year [6][9] - The company plans to pursue a de novo submission in early 2025, following a clinical trial with 30 to 60 patients, including patients from outside the United States [9][10] - The integration and build of the Version 1.0 System remains on track for this fall, with a focus on manufacturing units in preparation for verification and validation [8][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their innovative approach to transform the standard of care in surgical robotics [16] - The company is committed to disciplined spending and investment in high-value generating initiatives that advance development and regulatory processes [14][15] Other Important Information - The company has received clarity and reassurance on its path to complete clinical and regulatory submission plans following meetings with the FDA [6][8] - The primary endpoint for the clinical trial will be the ability of the surgeon to complete the intended ventral hernia repair, with safety endpoints based on adverse event rates [10] Q&A Session Summary Question: Number of sites for the trial and use of centers of excellence - Management confirmed the ability to use centers of excellence and is in the process of selecting surgeons and specific sites based on patient and surgeon criteria [19] Question: Initial manufacturing and production process - Management clarified that initial manufacturing is well underway, with the first systems expected to be fully integrated and tested in the fall [23] Question: Timeline for de novo application and commercialization - Management indicated that the de novo submission has a statutory review period of 150 days, and they are optimistic about the timing [26] Question: Risk assessment and FDA discussions - Management emphasized the importance of minimizing risks through rigorous testing and close collaboration with the FDA [30][31] Question: Surgeon feedback on the finalized system - Management noted that while full v1.0 system testing is still in progress, they have received substantial feedback from surgeons on various subcomponents [34] Question: New hospital partner opportunities - Management discussed the careful evaluation of new partnerships based on their potential value and the company's capacity to support them [37][46]