Monogram Orthopaedics (MGRM)

Search documents
Monogram Technologies Inc. (MGRM) Shareholder/Analyst Call Prepared Remarks Transcript
Seeking Alpha· 2025-09-30 18:52
PresentationBenjamin SexsonChairman of the Board, President & CEO Good morning. Welcome to the Special Meeting of Stockholders for Monogram Technologies, Inc. My name is Benjamin Sexson, and I am the Chairman of the Board of Directors of Monogram. On behalf of the company's officers and directors, it's a pleasure to have you with us today. And I would like to thank you for your interest in our company and for your participation in the call. I would now like to call to order the special meeting of stockhold ...
Monogram Orthopaedics (MGRM) - 2025 Q2 - Quarterly Report
2025-08-15 20:17
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _____________ Commission file number: 001-41707 Monogram Technologies Inc. (Exact name of registrant as specified in its charter) 3913 ...
Monogram Technologies Announces World's First Fully Autonomous Saw-Based Robotic Knee Replacement Surgery
Globenewswire· 2025-07-29 13:30
Core Viewpoint - Monogram Technologies Inc. has successfully completed the world's first fully autonomous saw-based robotic total knee arthroplasty (TKA) surgery on a live patient, marking a significant milestone in orthopedic surgery innovation [1][4][12]. Company Overview - Monogram Technologies Inc. is an AI-driven robotics company focused on revolutionizing orthopedic surgery, with a commitment to improving human health through advanced technologies [14]. - The company has developed the mBôs TKA System, which is designed to enhance the safety and effectiveness of knee replacement procedures [3][11]. Clinical Trial Details - The groundbreaking procedure took place at Krishna Shalby Hospital in Ahmedabad, India, as part of a multi-center clinical trial involving 102 total knee replacement procedures [2][3]. - The trial aims to evaluate the safety and effectiveness of the Monogram TKA System, with a three-month clinical follow-up period [3]. Regulatory Approvals - Monogram received regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) to import its mBôs TKA system for clinical investigation [3]. - The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Monogram's semi-autonomous TKA System, further validating its market readiness [12]. Strategic Partnerships - Monogram has partnered with Shalby Limited, one of the largest orthopedic hospital groups globally, to support the clinical investigation of the TKA System [11]. - Shalby Hospitals aims to lead innovation in joint replacement surgeries and has expressed strong support for the introduction of Monogram's robotic system [12]. Impact and Future Outlook - The successful execution of the autonomous knee replacement procedure is expected to have a significant positive impact on the standard of care in orthopedic medicine [4][9]. - Company executives have expressed confidence that the Monogram TKA System will lead to improved clinical outcomes and efficiency in knee replacement surgeries globally [8][9].
BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Monogram Technologies Inc. (Nasdaq - MGRM), Veritex Holdings, Inc. (Nasdaq - VBTX), ESSA Pharma Inc. (Nasdaq - EPIX), Waters Corporation (NYSE - WAT)
GlobeNewswire News Room· 2025-07-14 19:29
Mergers and Acquisitions - Monogram Technologies Inc. will be acquired by Zimmer Biomet Holdings, Inc. for $4.04 per share, totaling an equity value of approximately $177 million and an enterprise value of about $168 million. Shareholders may also receive a contingent value right worth up to $12.37 per share if certain milestones are met by 2030 [2] - Veritex Holdings, Inc. is set to be acquired by Huntington Bancshares Incorporated in a stock transaction where HBI will issue 1.95 shares for each Veritex share, implying a value of $33.91 per share and an aggregate transaction value of $1.9 billion [4] - ESSA Pharma Inc. will be acquired by XenoTherapeutics, Inc. for approximately $1.91 in cash per share, along with a contingent value right that could yield up to $0.06 per share within 18 months post-transaction [6] - Waters Corporation will merge with Becton, Dickinson and Company, with BD's shareholders expected to own about 39.2% and Waters' shareholders approximately 60.8% of the combined entity [8] Investigations - Investigations are ongoing regarding whether the boards of Monogram, Veritex, ESSA, and Waters breached their fiduciary duties by failing to conduct fair processes in their respective transactions and whether the deal considerations provide fair value to shareholders [2][4][6][8]
MGRM Alert: Monsey Firm of Wohl & Fruchter Investigating Fairness of the Sale of Monogram Technologies to Zimmer Biomet
GlobeNewswire News Room· 2025-07-14 16:38
Core Viewpoint - Wohl & Fruchter LLP is investigating the fairness of the proposed sale of Monogram Technologies, Inc. to Zimmer Biomet for $4.04 per share in cash, along with a contingent value right that could yield up to $12.37 per share if certain milestones are met by 2030 [1][3]. Group 1 - Monogram has agreed to be sold to Zimmer Biomet for an upfront payment of $4.04 per share in cash, plus a non-tradeable contingent value right (CVR) that could provide additional cash based on future milestones [1][3]. - Investors have expressed disappointment regarding the sale price, with comments indicating that the price is perceived as too low [2][4]. - Wohl & Fruchter LLP is examining whether the Monogram Board of Directors acted in the best interests of shareholders and if the sale price is fair [4].
Zimmer Biomet Announces Definitive Agreement to Acquire Monogram Technologies, Expanding Robotics Suite with Autonomous Solutions
Globenewswire· 2025-07-14 11:35
Core Viewpoint - Zimmer Biomet is acquiring Monogram Technologies to enhance its orthopedic robotics and navigation technologies, aiming to create a comprehensive portfolio that meets diverse surgeon needs. The acquisition is expected to be neutral to adjusted earnings per share from 2025 to 2027 and accretive thereafter, contributing to revenue growth starting in 2027 [1][6][7]. Group 1: Acquisition Details - Zimmer Biomet will acquire Monogram for $4.04 per share, totaling approximately $177 million in equity value and $168 million in enterprise value. Monogram shareholders will also receive a contingent value right (CVR) that could yield up to $12.37 per share based on future milestones [1][6]. - The transaction has been unanimously approved by the boards of both companies and is expected to close later this year, pending regulatory approvals and stockholder consent [8][6]. Group 2: Technological Advancements - Monogram's semi- and fully autonomous robotic technologies are anticipated to enhance Zimmer Biomet's ROSA Robotics platform, which is already a market leader outside the U.S. [2][4]. - Monogram has developed a CT-based, semi-autonomous robotic technology for total knee arthroplasty (TKA), which received FDA clearance in March 2025 and is expected to be commercialized with Zimmer Biomet implants in early 2027 [2][4]. Group 3: Strategic Implications - The acquisition is seen as a strategic move to strengthen Zimmer Biomet's position in the rapidly growing orthopedic robotics segment, with expectations of increased robotic knee adoption and a broader product range to attract new customers [6][7]. - Zimmer Biomet aims to become the first company to offer a fully autonomous surgical robot in orthopedics, potentially redefining standards of care in the field [3][2]. Group 4: Financial Outlook - The acquisition is projected to be neutral to adjusted earnings per share in 2025, 2026, and 2027, with expectations of accretion starting in 2028. It is also anticipated to generate high-single digit returns on invested capital by year five [7][6]. - Funding for the acquisition will come from a combination of cash on hand and available debt financing, with Zimmer Biomet maintaining a strong balance sheet [5][6].
Monogram Orthopaedics (MGRM) - 2025 Q1 - Earnings Call Transcript
2025-05-14 21:32
Financial Data and Key Metrics Changes - For the three months ended March 31, 2025, the company reported $13.3 million in cash, reflecting an operating cash flow of $2.3 million for the quarter, resulting in a monthly cash burn of approximately $800,000, down from $1.1 to $1.2 million last year [5][6] - The company forecasts a monthly cash burn of about $1 million to sustain operations through the milestones set for the remainder of the year, indicating a strong balance sheet with over a year’s worth of cash available [6] Business Line Data and Key Metrics Changes - The company has received FDA clearance for its embossed total TKA system, marking a significant milestone in its operations [8] - A pilot placement program has been initiated with a major institution in the U.S., involving approximately four surgeons to demonstrate the system's clinical performance [9] Market Data and Key Metrics Changes - The orthopedic surgery market is highly consolidated, with Stryker holding a significant market share of approximately 70% with its Mako robot, which presents a competitive landscape for the company [14][15] - The company aims to capitalize on the demographic shift in orthopedic surgeons, with a significant portion expected to retire by 2031, potentially allowing for increased market share [16] Company Strategy and Development Direction - The company is focused on commercializing what it believes to be the first autonomous saw-based cutting robot for total knee arthroplasty, positioning itself at the forefront of a paradigm shift in orthopedic surgery [13] - The strategy includes a slow and methodical rollout of the system to ensure high service levels and surgeon support, with plans for accelerated commercial growth once a solid foundation is established [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential impact of robotic precision and efficiency in orthopedic surgeries, while acknowledging the need for continued validation through live patient surgeries [11][18] - The company is actively exploring capital opportunities to accelerate growth, indicating strong interest from investors as it prepares for clinical trials and pilot placements [61][62] Other Important Information - The company has made substantial hardware and software improvements since its last submission to the FDA, enhancing the system's capabilities [9][49] - The first live patient surgeries with the Emboss system are expected to occur in the summer or early fall of 2025, representing a key inflection point for the company [18] Q&A Session Summary Question: Can you provide more detail on timelines for the U.S. and India? - The company expects to conduct live patient surgeries in India within 90 business days and anticipates the first placement in the U.S. to occur in Q2 or early Q3 2025 [24][25] Question: What differentiators will allow Monogram to compete with Stryker? - The company aims to focus on accuracy, safety, and minimal surgeon skill required for execution, with plans to leverage AI for landmark identification to enhance system performance [30][31][34] Question: Can you elaborate on system enhancements? - Significant enhancements have been made to the feed rate and cutting speed of the robot, with ongoing internal testing to ensure safety and effectiveness [48][49] Question: Is the domestic launch a full commercial launch or a trial? - The domestic launch is termed a pilot launch, allowing for real-world evaluation and surgeon feedback before a broader rollout [51][52] Question: What are the capital needs for upcoming trials and commercialization? - The company is exploring additional capital to accelerate growth, with a focus on derisking the opportunity through successful live patient surgeries [61][63]
Monogram Orthopaedics (MGRM) - 2025 Q1 - Earnings Call Transcript
2025-05-14 21:30
Financial Data and Key Metrics Changes - For Q1 2025, the company reported cash of $13.3 million, with an operating cash flow of $2.3 million, resulting in a monthly cash burn of approximately $800,000, down from $1.1 to $1.2 million last year [5][6] - The company forecasts a monthly cash burn of about $1 million for the remainder of the year, indicating a strong balance sheet with over a year of cash available [6] Business Line Data and Key Metrics Changes - The company is in the final stages of the verification and validation phase of its robotic system development, which has allowed for a reduction in variable costs [5] - The company has 27 full-time employees focused on ongoing R&D to achieve set milestones [5] Market Data and Key Metrics Changes - The orthopedic surgery market is highly consolidated, with Stryker holding a significant market share of approximately 70% with its Mako robot [15][16] - The company aims to capitalize on the generational shift in orthopedic surgery, as many new surgeons are being trained on robotic systems, which could lead to a significant market opportunity [17] Company Strategy and Development Direction - The company received FDA clearance for its embossed total TKA system, marking a significant milestone in its history [8][10] - The company plans to conduct a pilot placement with a major institution in the U.S. to demonstrate the system's value proposition and clinical performance [10] - The company is also preparing for a multicenter clinical trial in India, which will be the first clinical investigation involving autonomous robotic total knee surgeries on live patients [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential impact of robotic precision and efficiency in orthopedic surgeries [13][19] - The company believes it is at the forefront of a paradigm shift in orthopedic surgery, with plans to demonstrate its capabilities in live patient cases [14][19] Other Important Information - The company is actively showcasing its system with key opinion leaders and preparing for additional placements, emphasizing a slow and methodical rollout to ensure high service levels [11] - The company is exploring capital opportunities to accelerate growth, indicating a need for additional capital to support commercialization efforts [62] Q&A Session Summary Question: Can you provide more detail on timelines for the U.S. and India regarding technical and regulatory hurdles? - The company expects to perform live patient surgeries in India within 90 business days and anticipates the first placement in the U.S. to occur in Q2 or early Q3 [25][26] Question: What differentiators will allow Monogram to compete with Stryker? - The company aims to focus on accuracy, safety, and minimal surgeon fatigue, with plans to leverage AI for landmark identification and improve tensioning efficiency [31][33][39] Question: Can you provide more color on system enhancements? - Significant enhancements have been made to the feed rate and software of the robot, with ongoing internal testing to ensure safety and performance [50][51] Question: Is the domestic launch considered a trial or full commercial launch? - The launch is termed a pilot launch, allowing for real-world evaluation and surgeon training before broader commercialization [53][55] Question: What are the capital needs in light of upcoming clinical trials? - The company is actively exploring capital opportunities to accelerate growth, with strong interest from investors [62][63]
Monogram Technologies Reports First Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-05-14 20:01
Core Insights - Monogram Technologies Inc. has received FDA clearance for its mBôs™ Total Knee Arthroplasty (TKA) System, marking a significant milestone for the company and its technology [4][9] - The company is set to conduct a groundbreaking clinical trial for autonomous saw-based robotic TKA surgeries on live patients, which is expected to demonstrate the potential of robotic precision in surgical procedures [5][9] - Monogram is preparing for initial placements of the mBôs system with key opinion leader surgeons in the U.S. and advancing patient enrollment for the clinical trial in India [6][10] Financial Performance - Research and development expenses decreased by 6% to $2.3 million in Q1 2025, compared to $2.4 million in the same quarter of the previous year [11] - Marketing and advertising expenses saw a significant decrease of 63%, dropping to $44,000 from $120,000 year-over-year [12] - General and administrative expenses were $1.0 million, slightly down from $1.1 million in the prior-year quarter, with a net loss of $3.2 million for Q1 2025, an improvement from a net loss of $3.5 million in Q1 2024 [13] Cash Position - As of March 31, 2025, cash and cash equivalents totaled $13.3 million, down from $15.7 million at the end of 2024, indicating a focus on capital efficiency in commercialization efforts [14] Upcoming Initiatives - The company plans to initiate patient enrollment for the clinical trial and begin the first live patient surgeries in India within 90 business days [9][10] - Monogram is also exploring additional domestic and international partnerships to support the commercialization of the mBôs TKA System [7][10]
Monogram Orthopaedics (MGRM) - 2025 Q1 - Quarterly Report
2025-05-14 19:59
Regulatory Approvals - Monogram Technologies Inc. received FDA 510(k) clearance for its Monogram mBôs™ TKA System on March 17, 2025, allowing the company to market the device[57]. Financial Performance - The company reported a net loss of $3.2 million for the three months ended March 31, 2025, compared to a net loss of $3.5 million for the same period in 2024, reflecting a decrease in losses[68]. - The Company incurred a net loss of $3.2 million for the three months ended March 31, 2025, with an accumulated deficit of $71.4 million[73]. - Cash used in operating activities for the three months ended March 31, 2025, was $2.3 million, compared to $3.6 million for the same period in 2024[80][81]. Operating Expenses - Total operating expenses for the three months ended March 31, 2025, were $3.334 million, an 8% decrease from $3.610 million in the same period of 2024[63]. - Research and development expenses decreased by 6% to $2.258 million for the three months ended March 31, 2025, primarily due to the completion of the verification and validation phase of the Monogram mBôs™ TKA System[63]. - Marketing and advertising expenses decreased by 63% to $44,000 for the three months ended March 31, 2025, compared to $120,000 in the same period of 2024[65]. Cash and Capital Resources - The company had approximately $13.3 million in cash and working capital of approximately $12.1 million as of March 31, 2025[70]. - The Company expects its existing cash and cash equivalents, along with proceeds from financing deals, to meet anticipated cash requirements for at least 12 months[87]. - The Company has approximately $19.0 million worth of Common Stock available for sale under the Purchase Agreement with B. Riley Principal Capital II[71]. Equity and Financing - The Company sold 2,264,101 shares of Common Stock for total gross proceeds of $5.7 million through an equity offering program[72]. - The Company entered into a Common Stock Purchase Agreement allowing it to sell up to $20.0 million in shares to B. Riley Principal Capital II over a 24-month period[71]. - The Company has not yet generated profits and continues to rely on equity offerings and debt financings to support its operations[90]. Clinical Investigations - Monogram plans to conduct a 102-patient clinical investigation in India to evaluate the safety and effectiveness of the Monogram TKA System, with patient enrollment expected to start shortly[59]. - The company is focused on initial placements of its mBôs™ TKA System with key surgeon KOLs to establish clinical experience and demonstrate advantages in real-world settings[57]. Liabilities and Contingencies - As of March 31, 2025, the Company had total liabilities of $3.7 million, including trade accounts payable of $1.2 million and accrued liabilities of $650,000[77]. - The Company has a contingent liability estimated at $1.5 million related to a potential obligation to Mount Sinai under a licensing agreement[79]. Market and Economic Factors - Monogram is monitoring macroeconomic and geopolitical factors, including new tariffs and rising tensions in South Asia, which could impact future operations and costs[54]. Intellectual Property - The company has filed several patents around its active control scheme for robotic systems, which are currently under review[61]. Other Income - The Company received $82,000 from the exercise of warrants to purchase 20,054 shares of Common Stock during the three months ended March 31, 2025[75][84].