Financial Data and Key Metrics Changes - The company reported 10.9 million, indicating a cash run rate of approximately 13.99 million was achieved through financing activities, primarily from a successful preferred D raise that exceeded the initial target of $10 million [5][6] - The company maintains a highly variable cost structure with no traditional debt and minimal short-term warrant obligations related to the preferred D raise [6][7] Business Line Data and Key Metrics Changes - The company is focused on commercializing the first fully autonomous saw cutting robot, with all employees dedicated to this goal [9] - The submission of the first 510(k) application to the FDA was completed in July, with a subsequent additional information request received on September 30 [9][10] - The company plans to conduct an out-of-the-US clinical trial in India, collaborating with Shalby hospital chain, targeting 102 subjects for the trial [12][14] Market Data and Key Metrics Changes - The market dynamics are shifting, with 70% of fellowship programs having access to MAKO systems, and projections indicating that by 2030, one in two knee replacements will be robotic [18][19] - The company anticipates significant growth opportunities in international markets, particularly in India, where the robotic market is expanding [31][32] Company Strategy and Development Direction - The company aims to establish itself in the orthopedic robotics market by leveraging its technology to provide a more accurate and efficient surgical solution [18][19] - Plans for 2025 include launching the fully autonomous version of the robot and expanding international relationships to tap into underserved markets [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regulatory process with the FDA and the potential for successful commercialization of their robotic system [29][30] - The company believes that the demand for robotic-assisted surgeries will continue to grow, driven by demographic trends and the aging surgeon population [18][19] Other Important Information - The company has a strong balance sheet position and expects to meet its obligations with the current cash flow and capital access [7] - The clinical trial in India is seen as a critical step for market entry, with expectations for rapid patient enrollment due to the partnership with Shalby [12][31] Q&A Session Summary Question: What is the timeline for the out-of-US India trial? - Management indicated that they have received soft approval to import the unit for training purposes and are working with a clinical research organization to finalize the application [21] Question: Will marketing costs normalize in the fourth quarter? - Management confirmed that the high marketing expenses were primarily for the campaign and are expected to decrease significantly in the upcoming quarter [22] Question: What are the anticipated revenues for 2026? - Management expects faster growth outside the US compared to domestic markets, with potential for significant revenue generation in India post-clearance [31] Question: What are the cost-saving benefits of the robotic system? - The primary cost savings stem from improved surgical outcomes and efficiency, which can lead to reduced hospital costs and increased throughput [33][34] Question: How will surgeon training be handled post-clearance? - Management believes that the training required for surgeons to use the system will be minimal, with a fast learning curve anticipated [35] Question: What is the business model for the robotic system? - The company is adopting a razor/razor blade model, where the capital equipment is offered at a lower price in exchange for commitments on consumables [36]
Monogram Orthopaedics (MGRM) - 2024 Q3 - Earnings Call Transcript