Myomo, Inc. (MYO) came out with a quarterly loss of $0.08 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.10 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this company would post a loss of $0.02 per share when it actually produced a loss of $0.01, delivering a surprise of 50%.Over the last four quarters, the company has surpassed consensus EPS estimates three times.Myomo, which belongs to the Zacks Medical - Prod ...

Myomo (MYO) Q1 2025 Earnings Call May 07, 2025 04:30 PM ET Company Participants Tirth Patel - Vice President - IRPaul Gudonis - Chairman & CEODavid Henry - Chief Financial OfficerAnthony Vendetti - Executive Managing DirectorSean Lee - VP - Equity Research Conference Call Participants Chase Knickerbocker - Senior Equity Research Analyst - HealthcareScott Henry - Managing Director & Senior Research AnalystEdward Woo - Senior Research Analyst Operator Good afternoon, and welcome to the Myomo's First Quarter t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 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 001-38109 MYOMO, INC. (Exact name of Registrant as Specified in its Charter) Delaware 47-0944526 (State or Other Jurisdiction of ( ...

Myomo Reports First Quarter 2025 Financial and Operating Results Exhibit 99.1 Revenue of $9.8 million Record 700 patients added to the pipeline More than 300 Certified Prosthetists Orthotists have completed initial MyoPro® training Conference call being held today at 4:30pm Eastern time BURLINGTON, Mass. (May 7, 2025) – Myomo, Inc. (NYSE American: MYO) ("Myomo" or the "Company"), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper ...

Myomo, Inc. (MYO) came out with a quarterly loss of $0.01 per share versus the Zacks Consensus Estimate of a loss of $0.02. This compares to loss of $0.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 50%. A quarter ago, it was expected that this company would post a loss of $0.04 per share when it actually produced a loss of $0.03, delivering a surprise of 25%.Over the last four quarters, the company has surpassed consensus ...

Myomo, Inc. (NYSE:MYO) Q4 2024 Earnings Conference Call March 10, 2025 4:30 PM ET Company Participants Tirth Patel - Alliance Advisors, Investor Relations Paul Gudonis - Chief Executive Officer Dave Henry - Chief Financial Officer Conference Call Participants Chase Knickerbocker - Craig-Hallum Scott Henry - AGP Anthony Vendetti - Maxim Group Sean Lee - H.C. Wainwright Edward Woo - Ascendiant Capital Operator Good afternoon, and welcome to the Myomo Fourth Quarter 2024 Earnings Conference Call. All participa ...

Myomo (MYO) Q4 2024 Earnings Call March 11, 2025 12:37 AM ET Company Participants Tirth Patel - Vice President - IRPaul Gudonis - Chairman, President & CEODavid Henry - Chief Financial OfficerAnthony Vendetti - Executive Managing DirectorSean Lee - VP - Equity Research Conference Call Participants Chase Knickerbocker - Senior Equity Research Analyst - HealthcareScott Henry - Managing Director & Senior Research AnalystEdward Woo - Director of Research & Senior Analyst Operator Good afternoon, and welcome to ...

Market Opportunity - The addressable market in the U.S. for products aimed at individuals with upper extremity paralysis is estimated at 3 million existing cases, with up to 20% potentially qualifying for MyoPro reimbursement[30]. - Approximately 250,000 new patients are added annually due to strokes and related injuries, with an estimated 25,000-50,000 potentially suitable for MyoPro each year[31]. - The MyoPro is expected to improve function in upper limbs for children with brachial plexus injuries, with a new version called MyoPal available in the next 1-2 years[42]. - The backlog of MyoPro units reached 272, representing an 18% increase from 230 units at the end of 2023, with an estimated maximum potential revenue of approximately $13.6 million[58]. Reimbursement and Regulatory Changes - The Centers for Medicare and Medicaid Services (CMS) reclassified MyoPro into the brace benefit category effective January 1, 2024, allowing for lump sum reimbursement[33]. - The reimbursement fees for MyoPro Motion W and Motion G are approximately $34,300 and $67,500 respectively, effective January 1, 2025, subject to annual inflationary adjustments[33]. - As of January 1, 2024, CMS will reimburse the MyoPro on a lump sum basis, with fees updated to approximately $34,300 for the Motion W and approximately $67,500 for the Motion G, effective January 1, 2025[87]. - The MyoPro is classified as Durable Medical Equipment (DME) under Medicare, and reimbursement is contingent on the device being deemed medically necessary and not experimental[88]. - The reclassification of MyoPro billing codes into the brace benefit category is expected to increase sales volume from that channel in 2025 and beyond[89]. Product Development and Innovation - Myomo's strategy includes introducing the MyoPro3 and MyoPal devices, aimed at expanding their product offerings for different age groups[29]. - The MyoPro technology utilizes patented electromyography control, allowing patients to self-initiate movement through their muscle signals[27]. - The MyoPro 2, introduced in June 2017, features improvements in control technology and a longer-lasting battery, while the MyoPro2+ was launched in January 2022 with enhanced capabilities[52]. - Clinical studies have shown statistically significant improvements in functional task performance for users of the MyoPro, including gains in motor function for individuals with chronic arm weakness[54]. - The company is committed to ongoing R&D, focusing on innovations in robotics, machine learning, and material science to enhance product offerings[50]. Intellectual Property - Myomo holds 35 patents in the U.S. and various countries, with expiration dates ranging from 2027 to 2042, and has 12 pending patent applications[34]. - Myomo holds 35 issued patents, with the longest term extending intellectual property rights until 2042[66]. - Myomo has 8 pending U.S. patent applications and 4 foreign applications under examination[66]. Financial Position - As of December 31, 2024, the company had approximately $24.7 million in unrestricted cash, restricted cash, and cash equivalents, primarily held for working capital purposes[295]. - The company invests cash in overnight money market funds that focus on short-term government or government-backed securities[295]. - The company aims to preserve capital to fund its operations[295]. Manufacturing and Operations - The manufacturing operations have moved to a new facility in Burlington, MA, which has double the manufacturing floor space compared to the previous location, with a current capacity of 120 units per month[96]. - The company plans to hire more than 100 additional employees by the end of 2025 to increase clinical, reimbursement, and manufacturing capacity[98]. Compliance and Regulations - The company is subject to various healthcare laws and regulations, including the federal Anti-Kickback Statute, which imposes strict compliance requirements[80]. - The company is subject to various federal and state healthcare laws, which could impact business operations and result in significant penalties if non-compliance is determined[84]. - The EU Medical Devices Regulation (EU MDR) requires compliance with general safety and performance requirements for medical devices[72]. - The FDA's Quality Management System Regulation Final Rule will become effective on February 2, 2026, impacting product development processes[77]. - The company actively maintains a quality management system in accordance with FDA's QSR and ISO 13485:2016 standards[77]. Market Presence and Relationships - The company has established relationships with major rehabilitation facilities, enhancing its market presence and patient referral network[36]. - The company has entered agreements with O&P providers in multiple countries, including the UK, Germany, and Australia, and received orders from providers outside the U.S. in 2024[59]. - The MyoPro has been approved by the VA system for impaired veterans, with over 130 VA facilities ordering devices for their patients[57]. - Myomo aims to establish itself as a market leader in myoelectric-controlled orthotics, leveraging its first-mover advantage in the U.S. and presence in international markets[55]. Employee Relations - The company has experienced no work stoppages and considers its relationship with employees to be good, with all employees subject to contractual agreements[97]. - The company’s future success is heavily reliant on its ability to attract and retain highly skilled employees and personnel[98]. Revenue Generation - Myomo's Motion G product generated 98% of the company's product revenue for the year ended December 31, 2024[66].

Financial Performance - Revenue for Q4 2024 was a record $12.1 million, up 154% compared to Q4 2023[4] - Full year revenue for 2024 was $32.6 million, representing a 69% increase compared to 2023[10] - The company expects 2025 revenue to be between $50 million and $53 million, an increase of 54% to 63% compared to 2024[13] - Product revenue for Q4 2024 reached $12,068,456, a significant increase of 153% compared to $4,756,383 in Q4 2023[24] Cash Flow and Profitability - The company generated its first-ever positive cash flow from operations of $3.4 million in Q4 2024[12] - Adjusted EBITDA for Q4 2024 was $0.2 million, marking the first positive Adjusted EBITDA in the company's history[9] - Net loss for the year ended December 31, 2024, was $6,183,729, an improvement from a net loss of $8,147,565 in 2023[28] - Adjusted EBITDA for the year ended December 31, 2024, was $(5,126,350), an improvement from $(6,952,426) in 2023[30] - The company reported a net cash used in operating activities of $(3,289,904) for the year ended December 31, 2024, compared to $(6,172,764) in 2023, indicating improved cash flow management[28] Operational Metrics - A record 233 MyoPro units were authorized and ordered in Q4 2024, an increase of 27% year-over-year[11] - The patient pipeline reached 1,389 candidates as of December 31, 2024, up 33% from the previous year[11] - The backlog of orders as of December 31, 2024, was 272 units, up 18% year-over-year[11] Cost and Expenses - Operating expenses for Q4 2024 were $8.9 million, a 60% increase compared to Q4 2023[7] - Operating expenses for the year increased to $29,392,041 in 2024, compared to $21,413,932 in 2023, reflecting a 37% increase[24] Profitability Metrics - Gross margin improved to 71.4% in Q4 2024, up from 65.3% in Q4 2023[6] - Gross profit for the year ended December 31, 2024, was $23,185,343, up from $13,182,383 in 2023, reflecting a 76% increase[24] Assets and Liabilities - Total current assets increased to $32,789,996 in 2024, compared to $13,650,983 in 2023, representing a growth of 140%[25] - Cash and cash equivalents rose to $24,372,373 in 2024, compared to $6,871,306 in 2023, marking a 254% increase[25] - Total liabilities increased to $17,530,022 in 2024, compared to $5,592,218 in 2023, representing a growth of 213%[25] Shareholder Information - The weighted average number of common shares outstanding increased to 37,758,837 in 2024 from 29,499,340 in 2023[24]

Financial Data and Key Metrics Changes - Revenue for Q3 2024 reached a record $9.2 million, up 83% year-over-year, driven by increased MyoPro volume and a higher average selling price (ASP) of approximately $57,200 [7][13] - The operating loss for Q3 2024 was $1 million, a reduction from a $2 million loss in the same period last year [17] - Net loss for Q3 2024 was $1 million or $0.03 per share, compared to a net loss of $2 million or $0.06 per share for Q3 2023 [17] - Gross margin for Q3 2024 was 75.4%, up from 68.7% in the prior year quarter, primarily due to higher ASP and fixed cost absorption [17] Business Line Data and Key Metrics Changes - The company added 645 medically qualified candidates to the patient pipeline, a 69% increase year-over-year [6] - Insurance authorizations and orders for MyoPro reached a record 225 units in Q3, up 44% year-over-year [6] - Revenue units delivered totaled 161 MyoPros, a 35% increase from the previous year [7] Market Data and Key Metrics Changes - 55% of product revenue in Q3 came from Medicare Part B patients, up from 47% in the previous quarter [14] - Revenue from Medicare Advantage plans represented 24% of Q3 revenue, down 26% year-over-year due to a challenging reimbursement environment [14] Company Strategy and Development Direction - The company aims to expand its distribution channel by engaging orthotics and prosthetics clinics across the U.S. and establishing contracts with payers for in-network status [5][10] - The focus is on building the O&P distribution channel while continuing to grow the direct provider business [42] - The company plans to move to a larger production facility to accommodate expected growth and shipments [11] Management's Comments on Operating Environment and Future Outlook - Management expressed frustration with some Medicare Advantage plans making it difficult for patients to receive care, leading to increased denials and appeals [9] - Positive developments were noted as some previously non-reimbursing Medicare Advantage plans began to cover MyoPro [10] - The company expects to achieve record revenue in Q4 2024, with guidance of $9.5 million to $10.5 million, representing 100% to 121% year-over-year growth [22] Other Important Information - The company has entered into contracts with Blue Cross Blue Shield of Massachusetts and Paradigm, covering 3 million lives [10] - International operations, particularly in Germany, generated $1.1 million in revenue for Q3 2024 [12] - The company is preparing for a new facility that will increase production capacity and is expected to be operational by the end of the year [21] Q&A Session Summary Question: What percentage of Part B patients is supplemental insurance or Medicaid covering? - Approximately 20% to 25% of patients have supplemental insurance coverage, which impacts revenue recognition [29] Question: How quickly can O&P providers start generating revenue? - Initial orders from O&P providers are expected to materialize within six months after training [32] Question: What is the current production capacity and plans for the new facility? - Current production capacity is exceeding 80 units per month, with plans to double capacity in the new facility [34][35] Question: What is the value of the backlog and when will it be recognized? - The backlog of 316 units has a net value of over $10 million, with approximately 35% to 40% expected to turn into revenue one quarter out [45][47] Question: What are the international expansion plans? - The focus is on ramping up operations in Germany, with potential future expansions into France and Italy [50] Question: Any updates on R&D developments? - Enhancements to the MyoPro are in progress, with announcements expected in Q1 2025 [52]