Financial Data and Key Metrics Changes - Total operating expenses for the full year 2024 were $66.6 million, down 17% year-over-year [24] - R&D expenses for the full year 2024 were $40.2 million, down from $47.6 million in 2023 [24] - General and administrative expenses totaled $21.9 million in the full year 2024, down from $26.9 million in 2023 [24] - Adjusted net loss for the full year 2024 was $63.3 million, equating to an adjusted net loss of $10.75 per share, compared to an adjusted net loss of $76.3 million or $15.67 per share for the prior year [25] - GAAP net loss for the full year was $63.2 million, equating to a net loss of $10.74 per share, compared to a GAAP net loss of $71.1 million or $14.60 per share for the full year 2023 [25] - The 2024 cash burn rate was $49 million, achieving a favorable variance from the original guidance of approximately $50 million [26] Business Line Data and Key Metrics Changes - Sales and marketing expenses were $4.5 million in 2024, compared to $6.2 million in the prior year [24] Company Strategy and Development Direction - The company aims to transition into a clinical stage company in 2025, with significant milestones achieved in 2024, including the successful completion of the Version 1.0% system integration [8][9] - The Version 1.0% system is designed to deliver differentiated value through minimally invasive outcomes and advanced dexterity for surgeons [11][12] - Partnerships with leading U.S. hospital systems, including LSU Health New Orleans, Temple Health, and University of Illinois Health, have been established to enhance medical education and training protocols [13][15] - The company is preparing for its first clinical use and is in the process of securing institutional ethics committee approval for clinical sites [16] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the potential of the Version 1.0% system and its impact on surgical procedures, particularly ventral hernia repair [12][28] - The company anticipates treating its first clinical patients later in 2025, with a de novo submission expected to be late in 2026 [21][22] - Management emphasized the importance of maintaining a robust supply chain and manufacturing foundation to support future growth [19][20] Other Important Information - The company announced the appointment of a new CFO, Sarah Romano, who will officially join on April 1 [22][23] - The integration of the Version 1.0% system involved extensive testing and validation, leading to increased confidence in the system's reliability [55] Q&A Session Summary Question: Can you provide details on the supplier dynamic and its impact on manufacturing? - Management acknowledged material procurement challenges with key suppliers that led to delays in component deliverables, impacting manufacturing progress [35][36] Question: When do you anticipate the clinical trial beginning? - Management indicated that the first patients will be treated later in the year, with plans to kick off the pivotal trial shortly after [41][42] Question: Can you provide timing around the dossier submission? - The dossier submission is expected around the middle of the year, with the first patient timing taking a few months for approval [51] Question: What does the Version 1.0% integration entail? - The integration involved multiple cadaver procedures and extensive bench tests, leading to confidence in the system's performance and safety [55][61] Question: Can you quantify the inventory build for the clinical trial? - Management confirmed that they have finished instruments coming off the clean room lines and are focused on scaling up testing inventory [67][68]
Vicarious Surgical (RBOT) - 2024 Q4 - Earnings Call Transcript