Monogram Orthopaedics (MGRM) - 2023 Q4 - Annual Results

Operational and Strategic Highlights Key Operational Highlights Monogram Orthopaedics made significant operational strides in 2023-2024, securing 510(k) funding, delivering its first mBôs robot, and introducing mVision technology - The company is fully funded and on track for its 510(k) submission to the FDA in the second half of 2024, with Verification and Validation testing anticipated to be completed as early as the first half of 2024[4][5] - Achieved a key revenue milestone by delivering the first mBôs surgical robot to a major global robotics distributor, marking its first sale[3][4][9] - Introduced mVision technology, a new approach to surgical registration and tracking, which is being developed as a potential standalone product or for future integration into the mBôs system[4][8] - The company is proceeding with an OUS clinical trial to generate data that can support its U.S. 510(k) submission, if required by the FDA, or be used for post-launch marketing[4][7] Management Commentary Management emphasized 2023 as a transformative year, advancing mBôs commercialization, proactively modifying design for FDA equivalence, and targeting capital-efficient international growth - CEO Ben Sexson highlighted 2023 as a transformative first year as a public company, focusing on advancing the mBôs product launch and developing the next-gen product pipeline[3] - The company has preemptively made design changes, primarily related to foot pedal control, to address potential FDA technical equivalence concerns and possibly obviate the need for a clinical trial[6] - The new mVision navigation solution is designed to eliminate cart-based tracking, reduce surgical time, and minimize risks such as pin site fracture and infection[8] - Management views the international market as an attractive, capital-efficient opportunity to scale without the significant SG&A costs associated with implant sales in the U.S[9] Upcoming 2024 Milestones Monogram's 2024 milestones include completing mBôs system verification and validation, submitting its 510(k) application to the FDA, and commencing OUS live-patient surgical trials - Largely complete mBôs system verification and validation – H1 2024[17] - Submit semi-active modality 510(k) application to FDA – H2 2024[17] - Commence OUS live-patient surgery trials – H2 2024[17] Full Year 2023 Financial Results Financial Performance Summary Monogram's 2023 net loss remained stable at $13.74 million despite increased R&D expenses, aided by a positive change in warrant liability fair value, with year-end cash at $13.6 million Financial Performance Summary | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Research & Development Expenses ($) | $10.6 million | $5.4 million | | General & Administrative Expense ($) | $4.0 million | $2.5 million | | Net Loss ($) | $13.74 million | $13.69 million | | Cash and cash equivalents (Year-End) ($) | $13.6 million | $10.4 million | - The increase in R&D expenses was primarily due to development of the sagittal cutting systems and moving the robot prototype into the verification phase[12] - The 2023 net loss was positively impacted by a $3.1 million change in the fair market value of warrant obligations, whereas the 2022 result was negatively impacted by $3.4 million from the same item[14] Consolidated Balance Sheets As of December 31, 2023, Monogram's balance sheet showed increased total assets to $16.6 million and a substantial decrease in total liabilities to $3.2 million, significantly improving stockholders' equity to $13.4 million Consolidated Balance Sheets | Metric | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents ($) | $13,589,028 | $10,468,645 | | Total Assets ($) | $16,579,008 | $13,690,063 | | Total Liabilities ($) | $3,181,942 | $9,540,886 | | Total Stockholders' Equity ($) | $13,397,066 | $4,149,176 | Consolidated Statements of Operations Monogram reported its first revenue of $364,999 in 2023, with total operating expenses increasing to $17.6 million, yet net loss remained stable at $13.7 million due to warrant liability adjustments, improving loss per share to $0.61 Consolidated Statements of Operations | Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue ($) | $364,999 | $0 | | Total Operating Expenses ($) | $17,633,028 | $10,613,147 | | Loss from Operations ($) | ($17,268,029) | ($10,613,147) | | Net Loss ($) | ($13,745,217) | ($13,690,947) | | Basic and Diluted Loss Per Share ($) | ($0.61) | ($1.42) | Consolidated Statements of Cash Flows In 2023, Monogram used $13.5 million in operating cash, offset by $16.7 million from financing activities, resulting in a net cash increase of $3.1 million and a year-end cash balance of $13.6 million Consolidated Statements of Cash Flows | Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Cash used in operating activities ($) | ($13,542,509) | ($8,419,553) | | Cash used in investing activities ($) | ($64,913) | ($241,203) | | Cash provided by financing activities ($) | $16,727,805 | $13,593,691 | | Net increase in cash ($) | $3,120,383 | $4,932,935 | | Cash and cash equivalents, end of year ($) | $13,589,028 | $10,468,645 | Corporate Information Business Update Conference Call Monogram management will host a business update conference call on Thursday, March 21, 2024, at 5:00 p.m. Eastern Time, featuring key executives - The company will host a business update conference call on Thursday, March 21, 2024, at 5:00 p.m. Eastern Time[1][18] - Key executives including the CEO, Chief Medical Officer, Chief Technology Officer, and Chief Financial Officer will host the call[16] About Monogram Orthopaedics Monogram Orthopaedics is a medical technology company developing patient-optimized orthopedic implants through 3D printing, robotics, and imaging, currently awaiting FDA 510(k) clearance for its products - Monogram's long-term goal is to create patient-optimized orthopedic implants by linking 3D printing and robotics with advanced pre-operative imaging[19] - The company has not yet obtained FDA 510(k) clearance for its robotic products, which is a necessary step for commercialization in the United States[19]