Monogram Technologies (MGRM) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Noel Knape - Chief Financial OfficerBenjamin Sexson - CEONone - Executive Conference Call Participants Thomas Kerr - Senior AnalystJason Wittes - Managing Director & Senior Research Analyst Operator Good afternoon, everyone, and welcome to the Monogram Technologies first quarter twenty twenty five financial results and business update conference call. A question and answer session will follow the formal presenta ...

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]

Receives FDA Clearance for the mBôs™ TKA System Groundbreaking Trial Set to Deliver one of the World’s First Autonomous Saw-Based Robotic TKA Surgeries on Live Patients Management to Host Business Update Conference Call Today at 4:30 p.m. Eastern Time AUSTIN, Texas, May 14, 2025 (GLOBE NEWSWIRE) -- Monogram Technologies Inc. (NASDAQ: MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, has reported its financial and ...

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].

Financial Data and Key Metrics Changes - The company ended the year with a cash balance of $15.7 million, which is higher than the previous year's cash balance, attributed to frugal spending and a successful $13 million preferred D raise [7][9]. - Monthly cash burn has been maintained at around $1.2 million, with a slight reduction to approximately $1.1 million [91]. Business Line Data and Key Metrics Changes - The company has 27 full-time employees and leverages outsourced engineering talent as needed, scaling back on outsourcing in Q4 as the BNB project wound down [9]. - The company is focused on developing a robotic system for orthopedic surgeries, particularly knee replacements, which is expected to see increased adoption in the future [12][14]. Market Data and Key Metrics Changes - Robotic utilization in total knee replacements is currently low, but forecasts suggest that one out of two knee replacements could be robotic within the next five years [17]. - The company believes that the market is currently digesting robotics as a growth driver, with significant potential for future growth [14][15]. Company Strategy and Development Direction - The company aims to develop a fully autonomous robotic system for orthopedic surgeries, which is expected to be competitive in the market [24][37]. - The strategy includes addressing the market pain points in robotic knee surgery and expanding into other clinical applications with a high degree of freedom robotic arm [37]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming milestones and the strong balance sheet, indicating readiness to enter the next stage of development [9][10]. - The company is awaiting FDA clearance for its robotic system, with the timeline largely out of its control, but has made every effort to address the FDA's questions [41][119]. Other Important Information - The company is working with the Indian Regulatory Agency to initiate a clinical trial, with training already conducted for the involved surgeons [42][43]. - The upgraded end effector for the robotic system has exceeded expectations in terms of performance, with cutting speeds now competitive with manual surgery [71][72]. Q&A Session Summary Question: What is the anticipated duration of the trial in India once approvals are received? - Management indicated that from clearance to the first surgery would take about two months, with patient enrollment expected to start four weeks after clearance [56][60]. Question: What is the cash burn for this quarter and the outlook for 2025? - The cash burn rate has been reduced to approximately $1.1 million per month, with expectations to maintain this level going forward [91][96]. Question: How will the FDA's recent budget cuts affect clinical trials? - Management confirmed that the FDA's orthopedic devices branch has not indicated any impact from budget cuts on their application review process [105][106]. Question: What happens after FDA approval regarding robot deployment in hospitals? - Management stated that there would be a ramp-up period for working capital and system upgrades before launching the product in hospitals [112][113].

Financial Performance - Monogram Technologies reported revenue of $364,999 for the year ended December 31, 2023, from the sale of a single unit of robotic surgical equipment, with no product sales in 2024 anticipated before obtaining regulatory approvals[246]. - Revenue for 2024 was reported at $0, a decrease from $365,000 in 2023, indicating a decline of 100%[316]. - The company reported a net loss of $16.3 million in 2024, compared to a net loss of $13.7 million in 2023[256]. - Net loss for 2024 was $16,328,000, compared to a net loss of $13,745,000 in 2023, representing an increase in loss of 18.8%[316]. - Basic and diluted loss per common share improved to $(0.51) in 2024 from $(0.61) in 2023[316]. - The company has an accumulated deficit of $68.0 million as of December 31, 2024, highlighting ongoing financial challenges[345]. - Cash used in operating activities was $13.97 million for 2024, slightly higher than $13.54 million in 2023, indicating a 3.2% increase in cash outflow[345]. - The company experienced a $1.2 million charge for stock-based compensation in 2024, contributing to the cash used in operating activities[277]. Operating Expenses - Total operating expenses decreased by 13% from $17,633,000 in 2023 to $15,310,000 in 2024, with research and development expenses down 17% to $8,790,000[247]. - Operating expenses for marketing and advertising decreased by 30% from $2,994,000 in 2023 to $2,108,000 in 2024[247]. - General and administrative expenses increased by 9% in 2024 from 2023, mainly due to a full year of public company expenses, including insurance and regulatory compliance[251]. - Total operating lease expense for the year ended December 31, 2024 was $136,000, slightly down from $141,000 in 2023[391]. Cash and Capital - As of December 31, 2024, the company had approximately $15.7 million in cash and total stockholders' equity of $14.5 million, with working capital of approximately $14.8 million[257]. - Cash and cash equivalents increased to $15,658,000 in 2024 from $13,589,000 in 2023, an increase of 15.3%[314]. - The company anticipates that existing cash and cash equivalents will be sufficient to meet cash requirements for at least 12 months from the date of the annual report[294]. - The company raised $5.19 million from common stock issuances in 2024, down from $15.33 million in 2023, indicating a decrease of approximately 66.2%[345]. - The company has not yet generated revenue from its principal operations, with revenue recognized in 2023 related to the sale of a single unit of robotic surgical equipment[335]. Regulatory and Development Efforts - The Company submitted its 510(k) application for the surgical robot on July 19, 2024, which passed the initial FDA Administrative Review, but is currently on hold pending a complete response to an Additional Information Request[231]. - Monogram anticipates initiating a multicenter clinical trial in collaboration with Shalby Limited in 2025 to evaluate the safety and effectiveness of the Monogram TKA System[234]. - The company has not yet obtained 510(k) premarket clearances for any of its robotic products, which are necessary for commercialization[230]. - The company is focused on developing an autonomous surgical robot for orthopedic procedures, leveraging advanced technologies such as AI and machine vision[325]. - The company plans to continue its research and development efforts, with significant costs incurred in this area, including salaries and third-party contractor expenses[338]. Stock and Equity - The Company received gross proceeds of approximately $13 million from its Series D Preferred Stock Offering, which closed on October 2, 2024[241]. - The Series D Preferred Stock Offering closed on October 2, 2024, raising approximately $13 million from the sale of 5,773,979 shares and associated warrants[263]. - The company sold 292,726 shares of Common Stock to B. Riley Principal Capital II for gross proceeds of approximately $1.0 million, with the potential to sell an additional $19.0 million worth of Common Stock under the Purchase Agreement[260]. - The Company had stock options outstanding of 4,990,827 shares at December 31, 2024, with a weighted-average exercise price of $1.71 and a remaining contractual term of 7.0 years[378]. - The Company recognized no income tax expense for the years ended December 31, 2024 and 2023 due to net losses incurred[381]. Assets and Liabilities - Total current assets increased to $16,283,000 in 2024 from $14,618,000 in 2023, representing an increase of 11.4%[314]. - Total assets rose to $17,770,000 in 2024, up from $16,579,000 in 2023, reflecting a growth of 7.2%[314]. - The company reduced total liabilities to $1.7 million as of December 31, 2024, down from $2.5 million in 2023, primarily due to decreased accounts payable[273]. - The company recorded a $3.1 million increase in the fair value of the warrant liability for the year ended December 31, 2023[280]. - The company has a contingent obligation estimated at $1.5 million related to a potential "Significant Transaction" with Mount Sinai[389].

Financial Performance - Monogram Technologies reported a net loss of $16.3 million for the year ended December 31, 2024, compared to a net loss of $13.7 million in 2023, reflecting an increase of 19%[14]. - Net loss for the year ended December 31, 2024, was $14.815 million, compared to a net loss of $13.745 million for the year ended December 31, 2023[31]. - Cash used in operating activities increased to $13.968 million in 2024 from $13.543 million in 2023[31]. Expenses - Research and development expenses decreased by 17% to $8.8 million in 2024 from $10.6 million in 2023, primarily due to the completion of verification and validation phases[12]. - Marketing and advertising expenses decreased by 30% to $2.1 million in 2024 from $3.0 million in 2023, influenced by market conditions affecting fundraising efforts[13]. - General and administrative expenses increased by 9% to $4.4 million in 2024 from $4.1 million in 2023, mainly due to public company expenses[14]. - Stock-based compensation decreased to $1.174 million in 2024 from $1.559 million in 2023[31]. Cash and Financing - Cash and cash equivalents totaled $15.7 million as of December 31, 2024, up from $13.6 million as of December 31, 2023[15]. - Cash and cash equivalents at the end of the year increased to $15.658 million from $13.589 million[31]. - Proceeds from issuances of Common Stock, net, were $5.191 million in 2024, down from $15.331 million in 2023[31]. - Proceeds from issuances of Series D Preferred Stock, net, amounted to $11.130 million in 2024[31]. - Cash provided by financing activities was $16.121 million in 2024, slightly down from $16.728 million in 2023[31]. Operational Developments - Monogram completed an upsized and oversubscribed public offering raising $13 million to support strategic initiatives, including clinical trials and technology development[4]. - The company is awaiting FDA clearance for its mBôs™ Total Knee Arthroplasty System, which would enable commercialization in the U.S.[11]. - Monogram has successfully shipped a robot to India for clinical trial training and held an Investigator Meeting at a Shalby Hospital to review study protocols[9]. - Monogram plans to enhance system performance and explore domestic and international relationships as it moves toward commercialization[11]. Recognition - The company was named Orthopedic Joint Replacement Company of the Year 2024 by Medical Tech Outlook, highlighting its industry recognition[10]. Equipment and Accounts Payable - Purchases of equipment increased to $84,000 in 2024 from $65,000 in 2023[31]. - The company experienced a decrease in accounts payable, with a change of $(1.289) million in 2024 compared to an increase of $1.799 million in 2023[31].

Financial Data and Key Metrics Changes - The company reported $16.5 million in cash at the end of Q3 2024, with a year-to-date operating cash flow of $10.9 million, indicating a cash run rate of approximately $1.2 million per month [5][6] - A significant financial raise of $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]

Financial Performance - The Company reported a net loss of $5,034,501 for the three months ended September 30, 2024, an 80% increase from a net loss of $995,660 for the same period in 2023 [66]. - For the nine months ended September 30, 2024, the net loss was $12,078,661, a 16% increase compared to a net loss of $10,090,923 for the same period in 2023 [66]. - The Company incurred cash used in operating activities of $12,078,661 for the nine months ended September 30, 2024, compared to $10,090,923 for the same period in 2023 [81]. - The Company has an accumulated deficit of $63,708,186 as of September 30, 2024 [72]. Revenue and Sales - The Company did not make any sales during the nine months ended September 30, 2024 or 2023, and does not anticipate additional sales before initiating a clinical study and obtaining regulatory approvals [59]. Expenses - Total operating expenses increased by 37% during the three months ended September 30, 2024, totaling $5,147,122, while decreasing by 7% during the nine months ended September 30, 2024, totaling $12,390,803 [63]. - Research and development expenses decreased by 17% to $2,214,729 for the three months ended September 30, 2024, and by 7% to $7,047,112 for the nine months ended September 30, 2024 [60]. - Marketing and advertising expenses surged by 5,607% to $1,838,937 during the three months ended September 30, 2024, driven by a marketing campaign for the Series D Preferred Stock Offering [61]. - General and administrative expenses increased by 3% during the three months ended September 30, 2024, and by 11% during the nine months ended September 30, 2024, primarily due to higher insurance and regulatory compliance costs [62]. Cash and Financing - As of September 30, 2024, the Company had approximately $16.6 million in cash on hand and working capital of approximately $16.1 million [67]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $13,991,161, compared to $14,877,980 for the same period in 2023 [85]. - The Company has sold 292,726 shares of Common Stock to B. Riley Principal Capital, II LLC for gross proceeds of $961,245, leaving approximately $19 million worth of Common Stock available for sale [69]. - The Company plans to continue raising additional capital through various financing options, including equity and debt offerings [67]. Regulatory and Compliance - The Company submitted a 510(k) premarket filing to the FDA for its semi-active mBôs TKA System, which is currently under review [51]. - Monogram anticipates holding an issue-specific meeting with the FDA by December 2024 to address the Additional Information Request received [52]. - The Company has 180 days from receiving the AIR to respond with the requested information, which may include clinical data [53]. Liabilities and Obligations - Total liabilities as of September 30, 2024, were $2.8 million, primarily consisting of vendor accounts payable of $1.5 million [79]. - The Company is obligated to issue Pro-Dex a warrant exercisable into 298,122 shares of Series D Preferred Stock at an exercise price of $2.25 per share due to exceeding $5 million in gross proceeds from offerings [78]. Going Concern - The company's ability to continue as a going concern depends on its ability to generate revenues and raise capital to meet current and future obligations [95]. - The company may remain an "emerging growth company" for up to five years starting January 26, 2022, unless the market value of its Common Stock held by non-affiliates exceeds $700 million [98]. - The company is subject to less rigorous public reporting requirements as an "emerging growth company," potentially providing shareholders with less information than more mature public companies [99].

Financial Performance - The net loss for Q3 2024 was $5.0 million, compared to a net loss of $1.0 million in the prior-year quarter, primarily due to increased marketing expenses[15]. - For the three months ended September 30, 2024, Monogram Orthopaedics reported a net loss of $5,034,501, compared to a net loss of $995,660 for the same period in 2023[25]. - The net loss per common share for the three months ended September 30, 2024, was $(0.16), compared to $(0.03) for the same period in 2023[25]. - Total operating expenses for the nine months ended September 30, 2024, were $12,390,803, a decrease from $13,391,299 in the same period of 2023, reflecting a reduction of approximately 7.4%[25]. Research and Development - Research and development expenses for Q3 2024 were $2.2 million, down from $2.7 million in the prior-year quarter, due to finalizing the validation phase of its robot prototype[13]. - Research and development expenses for the three months ended September 30, 2024, were $2,214,729, compared to $2,664,542 for the same period in 2023, indicating a decrease of about 16.8%[25]. Marketing and Advertising - Marketing and advertising expenses surged to $1.8 million in Q3 2024, compared to $32,220 in the prior-year quarter, driven by a marketing campaign for the Series D preferred stock offering[14]. Cash and Assets - Cash and cash equivalents totaled $16.6 million as of September 30, 2024, up from $13.6 million as of December 31, 2023[16]. - Total assets increased to $20.2 million as of September 30, 2024, compared to $16.6 million as of December 31, 2023[24]. - The company reported cash and cash equivalents of $16,565,142 at the end of the period, an increase from $14,875,476 at the end of September 30, 2023[26]. Stock and Shares - Proceeds from issuances of Common Stock for the three months ended September 30, 2024, amounted to $4,177,931, compared to $15,254,300 for the same period in 2023[26]. - The weighted-average number of basic and diluted shares outstanding increased to 32,223,656 for the three months ended September 30, 2024, from 29,284,949 in the same period of 2023[25]. Regulatory and Strategic Developments - The company received an Additional Information Request from the FDA regarding its 510(k) premarket filing for the mBôs TKA System, placing the application on hold pending a response[3]. - Monogram secured a strategic collaboration with Shalby Limited to conduct a multicenter clinical trial for the mBôs TKA System in India[3]. - The company anticipates an issue-specific meeting with the FDA by December 2024 to discuss the planned approach for responding to the AIR[11]. Recognition - Monogram was named Orthopedic Joint Replacement Company of the Year 2024 by Medical Tech Outlook, highlighting its industry recognition[4]. Other Financial Metrics - The company experienced a significant change in fair value of warrant liability, with a loss of $3,088,533 recorded in the nine months ended September 30, 2023[26]. - Monogram Orthopaedics reported stock-based compensation of $942,528 for the three months ended September 30, 2024, down from $1,158,499 in the same period of 2023[26]. - Cash used in operating activities for the nine months ended September 30, 2024, was $10,967,238, slightly higher than $10,430,384 for the same period in 2023[26].