Market Overview - The total joint replacement devices market was approximately $19.4 billion globally as of 2021, with the knee reconstruction market being a primary target for Monogram [56]. - In 2021, there were approximately 933,324 total primary knee replacements in the U.S., reflecting a 19% year-over-year increase from 2020 [65]. - The reconstructive joint replacement market is projected to grow at an annual rate of 3% to 3.4%, driven by an aging population and advancements in materials [58]. - The market for knee joint reconstruction sales was estimated at $9.0 billion in 2021, projected to reach $10 billion by 2025 [67]. - The robotic-assisted procedure growth rate in knees may reach 29.2% compounded annually over the next seven years, indicating a strong market opportunity for Monogram [62]. Product Development - Monogram Orthopaedics aims to develop patient-optimized orthopaedic implants using 3D printing and robotics, with a focus on high precision insertion through a robotic system [41]. - Monogram's robotic system is expected to be the first to market with a CT-based navigated seven joint robot arm capable of autonomous cutting [48]. - Approximately 10% of knees are currently uncemented, indicating significant room for increased utilization of robotics in joint reconstruction [61]. - The company is actively commercializing a robotic surgical system and aims to submit its surgical robot for Section 510(k) clearance with the FDA [70]. - The company expects the adoption of computer-assisted surgical robotics to continue, with approximately 514,000 TKA procedures projected to be robotic by 2027 [68]. Financial Performance - The company did not generate any revenues during the three months ended March 31, 2023, or 2022, as it focuses on the commercialization of its robotic products [75]. - Operating expenses totaled $3,896,065 for the three months ended March 31, 2023, a 3.3% increase from $3,770,952 in the same period of 2022 [76]. - Research and development costs increased by 78.2% to $1,720,488 for the three months ended March 31, 2023, compared to $965,308 for the same period in 2022 [77]. - The company generated a net loss of $3,858,722 for the three months ended March 31, 2023, a 15.9% decrease from a net loss of $4,504,659 for the same period in 2022 [80]. - The company reported a net loss of $3,858,722 for the year ended March 31, 2023, with an accumulated deficit of $41,622,169 [91]. Cash Flow and Capital Structure - As of March 31, 2023, the company had approximately $7.7 million in cash, with negative working capital of approximately $1.04 million [81]. - The company raised $21,129,000 from the Series B Offering and $4,599,145 from the Series C Offering, with net proceeds of $16,011,017 from the Common Stock Offering [83][84][85]. - Total liabilities as of March 31, 2023, were $9,783,056, with $7,516,578 attributed to the estimated fair value of warrant liability [86]. - Cash used in operating activities decreased by 27.7% to $2,882,377 for the three months ended March 31, 2023, compared to $3,680,609 for the same period in 2022 [94]. - Cash provided by financing activities was $147,042 during the three months ended March 31, 2023, significantly lower than $9,012,178 in the same period of 2022 [96]. Equity and Liabilities - Total current assets decreased to $8,274,004 as of March 31, 2023, from $24,285,021 [90]. - Total liabilities remained stable at $9,783,056 as of March 31, 2023 [90]. - The company has a total stockholders' equity of $805,636 as of March 31, 2023, down from $16,816,653 [90]. - The company has not yet generated profits and is dependent on its ability to produce revenues and/or obtain financing to meet obligations [92]. - The company plans to generate revenue and raise capital as needed to satisfy its capital needs [92]. Company Classification - The company is classified as an emerging growth company, allowing it to take advantage of certain reporting exemptions [106].
Monogram Orthopaedics (MGRM) - 2023 Q1 - Quarterly Report