Financial Data and Key Metrics Changes - At the end of Q1 2024, the company's cash balance was approximately $10.1 million, with a quarterly burn rate of about $3.6 million or $1.2 million per month, which is expected to reduce to around $1 million per month in subsequent quarters [16][56][47] - Management successfully paid down accounts payable by a net of $1.1 million, related to elevated balances from Q4 activities [16] Business Line Data and Key Metrics Changes - The company has 28 full-time employees, with 60% of costs being labor, indicating a highly variable cost structure that can be significantly reduced as verification and validation (V&V) activities wind down [5] - The verification and validation testing is ongoing, with 63% of electromechanical testing complete, and the software testing is about to begin [24][45] Market Data and Key Metrics Changes - The largest competitor, Stryker, holds an 89% market share in robotic joint replacements and 75% in the cementless knee market, indicating a monopolistic market structure [8][11] - The company aims to capture market share by offering an autonomous cutting robot, which is currently not available from significant competitors [20][21] Company Strategy and Development Direction - The company plans to complete IEC 60601 certification and submit a 510(k) for FDA clearance, with expectations to complete V&V testing by the end of Q2 2024 [23][43] - The strategic vision is to advance medicine through technology adoption, focusing on becoming the first company to offer an autonomous active cutting saw-based robot [28][57] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the FDA's understanding of their product and the feedback received during pre-submission communications, which is seen as constructive [18] - The company believes that achieving FDA clearance will significantly enhance its market position and facilitate entry into other markets [66] Other Important Information - The company is actively engaging with Tier 1 capital allocators and conducting site visits and demos to build relationships and support fundraising efforts [19][26] - The company has no debt and no warrant obligations, ensuring sufficient access to cash for upcoming milestones [47] Q&A Session Summary Question: Why and how does the FDA rely on an OUS clinical trial? - The FDA may rely on an OUS clinical trial to provide clinical data for marketing and to ensure safety and efficacy, with the trial being less than 100 patients and significantly cheaper than conducting it in the US [31][32] Question: What is the approval path for the active system? - The plan is to run a semi-active OUS trial first, followed by an active version trial, with a focus on building a long-term relationship with the clinical partner [33][34] Question: How does Monogram compete with Zimmer's ROSA system? - Monogram believes the opportunity lies in robotic cutting, as Mako is the only robot cutting system on the market, and Monogram aims to be the second player with an active cutting approach [64]
Monogram Orthopaedics (MGRM) - 2024 Q1 - Earnings Call Transcript