PART I [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements%20%28interim%20periods%20unaudited%29) The company reported a 162% revenue increase to $9.8 million in Q1 2025, alongside a $3.5 million net loss and a decrease in cash to $19.8 million [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $40.9 million by March 31, 2025, primarily due to reduced cash, while liabilities increased and equity declined Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $19,794 | $24,372 | | Accounts receivable, net | $4,663 | $3,825 | | Total Current Assets | $31,097 | $32,800 | | Total Assets | $40,867 | $42,244 | | Total Current Liabilities | $11,675 | $10,172 | | Total Liabilities | $19,180 | $17,530 | | Total Stockholders' Equity | $21,687 | $24,714 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2025 revenue surged 162% to $9.8 million, with gross profit rising to $6.6 million, and net loss narrowing to $3.5 million Q1 2025 vs. Q1 2024 Statement of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product revenue | $9,832 | $3,754 | | Gross profit | $6,610 | $2,299 | | Loss from operations | $(3,520) | $(3,889) | | Net loss | $(3,465) | $(3,836) | | Net loss per share | $(0.08) | $(0.10) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to $2.7 million in Q1 2025, but overall cash decreased by $4.6 million due to investing and lower financing Cash Flow Summary for the Three Months Ended March 31 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,677) | $(3,246) | | Net cash used in investing activities | $(1,896) | $(3,543) | | Net cash (used in) provided by financing activities | $(37) | $5,362 | | **Net (decrease) in cash** | **$(4,579)** | **$(1,437)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail liquidity, revenue recognition, financing, and customer concentration, with CMS representing 59% of Q1 2025 revenue despite a $3.5 million net loss - The company is a wearable medical robotics company that develops and sells the MyoPro®, a myoelectric upper limb orthosis, directly to patients and through various providers[25](index=25&type=chunk) - Despite a Q1 2025 net loss of approximately **$3.5 million** and negative operating cash flow of **$2.7 million**, management believes its current cash, investments, and expected cash flows will fund operations for at least the next twelve months[26](index=26&type=chunk)[27](index=27&type=chunk) - The company has access to a **$4.0 million** revolving line of credit and a **$3.0 million** term loan facility from Silicon Valley Bank, both of which were undrawn as of March 31, 2025[28](index=28&type=chunk)[74](index=74&type=chunk)[77](index=77&type=chunk) Revenue by Source (in thousands) | Source | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Direct to patient | $7,808 | $2,235 | | Clinical/Medical providers | $2,024 | $1,520 | | **Total revenue** | **$9,832** | **$3,754** | - Revenue from the United States constituted **87%** of total revenue in Q1 2025, up from 75% in Q1 2024. Revenue from Germany decreased to **13%** from 22% over the same period[49](index=49&type=chunk) - For Q1 2025, the Centers for Medicare & Medicaid Services (CMS) represented **59%** of product revenues. At March 31, 2025, CMS accounted for **46%** of accounts receivable[90](index=90&type=chunk)[91](index=91&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes 162% Q1 2025 revenue growth to direct billing and Medicare Part B, improving gross margin to 67.2% despite rising operating expenses and anticipated negative cash flows [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Q1 2025 revenue grew 162% to $9.8 million, driven by direct billing, with gross margin expanding to 67.2% and adjusted EBITDA loss improving to $2.8 million Q1 2025 vs. Q1 2024 Financial Performance | Metric | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Product revenue | $9,831,814 | $3,754,389 | $6,077,425 | 162% | | Gross profit | $6,609,630 | $2,299,044 | $4,310,586 | 187% | | Gross margin % | 67.2% | 61.2% | N/A | 6.0% | | Total operating expenses | $10,129,884 | $6,187,811 | $3,942,073 | 64% | - The revenue increase was primarily driven by higher direct billing revenues, which accounted for **79%** of product revenue in Q1 2025, up from 60% in Q1 2024. This was due to a higher average selling price (ASP) and higher volume from serving Medicare Part B beneficiaries[104](index=104&type=chunk) - Operating expenses increased across the board: R&D rose **87%** due to accelerated development efforts, SC&M increased **86%** from higher clinical headcount and advertising, and G&A grew **37%** from increased reimbursement and HR staff[111](index=111&type=chunk)[113](index=113&type=chunk)[115](index=115&type=chunk) Reconciliation of Net Loss to Adjusted EBITDA (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | GAAP net loss | $(3,465) | $(3,836) | | Interest income, net | $(192) | $(135) | | Depreciation expense | $158 | $30 | | Stock-based compensation | $540 | $320 | | Income tax expense | $137 | $82 | | **Adjusted EBITDA** | **$(2,822)** | **$(3,539)** | [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$21.5 million** in cash and investments, believing it has sufficient liquidity for 12 months despite anticipated negative cash flows from strategic investments Liquidity Position | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $19,793,799 | $24,372,373 | | Short-term investments | $1,730,460 | $492,990 | | **Total** | **$21,524,259** | **$24,865,363** | | Working capital | $19,422,008 | $22,618,158 | - The company has historically funded operations through equity and debt, including a **$15.8 million** net proceeds public offering in December 2024 and a **$5.4 million** net proceeds offering in January 2024[125](index=125&type=chunk) - Operating plans are focused on growing the direct billing channel, which will involve increased spending and is expected to result in negative cash flows for at least the first three quarters of 2025[126](index=126&type=chunk) [Critical Accounting Estimates](index=37&type=section&id=Critical%20Accounting%20Estimates) The most critical accounting estimate is revenue recognition, particularly for commercial insurance payers where timing depends on historical payment data or cash receipt - The most critical accounting estimate is the timing and amount of revenue recognition, which depends on estimates of payments from insurance payers[133](index=133&type=chunk) - For Medicare Part B, revenue is recognized upon delivery based on published CMS fees. For commercial insurers, revenue is recognized upon delivery only if sufficient payment history exists; otherwise, it is recognized upon cash receipt[134](index=134&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - This item is not applicable to the company as it is a smaller reporting company[136](index=136&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of March 31, 2025, due to a material weakness in IT general controls, with a remediation plan underway - Management concluded that disclosure controls and procedures were not effective as of March 31, 2025, due to a material weakness in internal control over financial reporting[140](index=140&type=chunk)[148](index=148&type=chunk) - The material weakness relates to a lack of design and maintenance of effective information technology (IT) general controls, including issues with privileged access rights, user provisioning, and change management for the financial reporting system[142](index=142&type=chunk) - A remediation plan is in progress to formalize IT processes. Changes to access rights and change management procedures were implemented in Q1 2025, with more enhancements planned for Q2 2025[144](index=144&type=chunk)[145](index=145&type=chunk) - Despite the material weakness, management has concluded that the condensed consolidated financial statements included in the report are fairly presented in all material respects[143](index=143&type=chunk) PART II [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material litigation requiring disclosure - There is no material litigation against the Company at this time that is required to be disclosed[151](index=151&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) Key risks include reduced Medicare Advantage revenues, negative impact from social media algorithm changes on lead generation, and potential U.S. tariffs - A significant risk is the reduction in authorizations from Medicare Advantage plans, which has negatively impacted revenues. These plans accounted for only **17%** of product revenue in Q1 2025, down from 38% in Q1 2024[153](index=153&type=chunk) - The company's lead generation efforts were adversely affected in Q1 2025 by an algorithm change at a social media advertising company, which is expected to negatively impact revenue growth in Q2 2025[154](index=154&type=chunk) - Potential U.S. tariffs on imports are identified as a risk, though the company estimates the impact on 2025 gross margin would be less than **100 basis points (1%)** if fully implemented[155](index=155&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds%20from%20Registered%20Securities) The company reported no unregistered sales of equity securities during the period - None[157](index=157&type=chunk) [Item 5 Other Information](index=44&type=section&id=Item%205%20Other%20Information) CFO David A. Henry adopted a Rule 10b5-1 trading plan on March 12, 2025, for the potential sale of up to 129,020 shares of common stock - On March 12, 2025, CFO David A. Henry adopted a Rule 10b5-1 trading plan to sell up to **129,020 shares** of common stock[158](index=158&type=chunk) [Item 6. Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, material contracts, and certifications - This section lists the exhibits filed with the Form 10-Q, including charter documents, the First Amendment to the Loan and Security Agreement, and Sarbanes-Oxley certifications[160](index=160&type=chunk)[161](index=161&type=chunk)

[Myomo First Quarter 2025 Financial and Operating Results](index=1&type=section&id=Myomo%20Reports%20First%20Quarter%202025%20Financial%20and%20Operating%20Results) [Financial and Operating Highlights](index=1&type=section&id=Financial%20and%20Operating%20Highlights) Myomo reported strong Q1 revenue growth of 162% to $9.8 million, a record 700 new patient pipeline additions, and expanded its CPO network Q1 2025 Key Metrics vs. Q1 2024 | Metric | Q1 2025 | YoY Change | | :--- | :--- | :--- | | Revenue | $9.8 million | +162% | | Revenue Units | 182 | +100% | | Orders and Authorizations | 213 units | +18% | | New Pipeline Candidates | 700 | +42% | | Total Patient Pipeline | 1,482 | +33% | | Backlog | 249 units | -9% | | Gross Margin | 67.2% | +600 bps | | Cost Per Pipeline Add | $2,300 | +31% | - Medicare Part B patients constituted a significant portion of the business, accounting for **59% of Q1 2025 revenue**[4](index=4&type=chunk) - The company has completed initial MyoPro® training for **over 300 certified prosthetist orthotists (CPOs)** as of March 31, 2025, expanding its clinical network[4](index=4&type=chunk) [Management Commentary](index=1&type=section&id=Management%20Commentary) Management cited operational challenges from Medicare Advantage plans and social media algorithms but noted a rebound in lead flow and pipeline additions - Operational challenges in Q1 were attributed to utilization management by Medicare Advantage plans and social media algorithm changes impacting lead flow[2](index=2&type=chunk) - **Lead flow and pipeline additions rebounded in March and April**, suggesting the negative impacts from early in the quarter may be temporary[2](index=2&type=chunk) [Detailed Financial Results](index=1&type=section&id=Financial%20Results) Revenue surged 162% to $9.8 million and gross margin improved to 67.2%, while the company narrowed its operating and net losses Q1 2025 vs Q1 2024 Financial Performance | Metric | Q1 2025 | Q1 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Product Revenue | $9.8M | $3.8M | +162% | | Gross Profit | $6.6M | $2.3M | +187% | | Gross Margin | 67.2% | 61.2% | +6.0 bps | | Operating Expenses | $10.1M | $6.2M | +64% | | Operating Loss | ($3.5M) | ($3.9M) | -10% | | Net Loss | ($3.5M) | ($3.8M) | -8% | | Net Loss per Share | ($0.08) | ($0.10) | -20% | | Adjusted EBITDA | ($2.8M) | ($3.5M) | -20% | - The increase in revenue was driven by a higher number of units (**182, up 100%**) and a higher Average Selling Price (ASP) of approximately **$54,000 (up 31%)**[5](index=5&type=chunk) - Operating expenses rose primarily due to higher payroll from increased headcount, increased R&D spending, and a **104% increase in advertising expenditures** to $1.6 million[7](index=7&type=chunk) [Operations Update](index=2&type=section&id=Operations%20Update) The patient pipeline grew 33% year-over-year with a record 700 new additions, while the order backlog decreased by 9% Operational Metrics (as of March 31) | Metric | 2025 | 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Patient Pipeline | 1,482 | 1,112 | +33% | | New Pipeline Adds (Q1) | 700 | 493 (implied) | +42% | | Authorizations & Orders (Q1) | 213 | 181 (implied) | +18% | | Backlog | 249 | 274 (implied) | -9% | - The decrease in backlog was attributed to a higher velocity of revenue, with **45% of Q1 revenue** being generated from authorizations and orders received within the same quarter[5](index=5&type=chunk)[10](index=10&type=chunk) [Cash Position](index=2&type=section&id=Cash%20Position) The company held $21.5 million in cash and equivalents at quarter-end, with cash used in operations improving to $2.7 million - Total cash, cash equivalents, and short-term investments were **$21.5 million** at the end of Q1 2025[11](index=11&type=chunk) - Cash used in operating activities for Q1 2025 was **$2.7 million**, compared to $3.2 million in Q1 2024[11](index=11&type=chunk) [Business Outlook](index=2&type=section&id=Business%20Outlook) Myomo projects Q2 revenue of $9.0-$9.5 million and reaffirms full-year 2025 guidance of $50-$53 million Revenue Guidance | Period | Revenue Guidance | YoY Growth (Full Year) | | :--- | :--- | :--- | | Q2 2025 | $9.0M - $9.5M | N/A | | Full Year 2025 | $50M - $53M | 54% - 63% | - The company expects revenue growth to **accelerate in the second half of 2025**[13](index=13&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) This section provides the unaudited condensed consolidated financial statements and a reconciliation of GAAP Net Loss to Adjusted EBITDA [Condensed Consolidated Statements of Operations](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) The company reported Q1 2025 product revenue of $9.8 million, a gross profit of $6.6 million, and a net loss of $3.5 million Q1 2025 Statement of Operations Highlights (in millions, except per share data) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product Revenue | $9.83 | $3.75 | | Gross Profit | $6.61 | $2.30 | | Loss from Operations | ($3.52) | ($3.89) | | Net Loss | ($3.47) | ($3.84) | | Net Loss Per Share | ($0.08) | ($0.10) | [Condensed Consolidated Balance Sheets](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2025, the company reported total assets of $40.9 million and total stockholders' equity of $21.7 million Balance Sheet Highlights (in millions) | Line Item | Mar 31, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $19.8 | $24.4 | | Total Current Assets | $31.1 | $32.8 | | Total Assets | $40.9 | $42.2 | | Total Liabilities | $19.2 | $17.5 | | Total Stockholders' Equity | $21.7 | $24.7 | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Net cash used in operating activities was $2.7 million for the quarter, an improvement from the prior year Q1 Cash Flow Summary (in millions) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($2.7) | ($3.2) | | Net Cash Used in Investing Activities | ($1.9) | ($3.5) | | Net Cash Provided by (Used in) Financing Activities | ($0.04) | $5.4 | | Net Change in Cash | ($4.6) | ($1.4) | [Reconciliation of GAAP Net Loss to Adjusted EBITDA](index=9&type=section&id=RECONCILIATION%20OF%20GAAP%20NET%20LOSS%20TO%20ADJUSTED%20EBITDA) Adjusted EBITDA loss improved to $2.8 million for Q1 2025 from a loss of $3.5 million in the prior-year period Adjusted EBITDA Reconciliation (in millions) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | GAAP Net Loss | ($3.47) | ($3.84) | | Adjustments | $0.65 | $0.30 | | Adjusted EBITDA | ($2.82) | ($3.54) |

Company Performance - Myomo, Inc. reported a quarterly loss of $0.01 per share, better than the Zacks Consensus Estimate of a loss of $0.02, and an improvement from a loss of $0.07 per share a year ago, representing an earnings surprise of 50% [1] - The company posted revenues of $12.07 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 24.54%, compared to year-ago revenues of $4.76 million [2] - Over the last four quarters, Myomo has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times [2] Stock Performance - Myomo shares have declined approximately 28.6% since the beginning of the year, while the S&P 500 has only declined by 1.9% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.07 on revenues of $6.8 million, and for the current fiscal year, it is -$0.07 on revenues of $37.22 million [7] Industry Outlook - The Medical - Products industry, to which Myomo belongs, is currently ranked in the bottom 45% of over 250 Zacks industries, indicating potential challenges for stock performance [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Myomo's stock performance [5]

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]

Company Performance - Myomo, Inc. reported a quarterly loss of $0.03 per share, better than the Zacks Consensus Estimate of a loss of $0.04, and an improvement from a loss of $0.06 per share a year ago, representing an earnings surprise of 25% [1] - The company posted revenues of $9.21 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 15.82%, and up from $5.08 million in the same quarter last year [2] - Over the last four quarters, Myomo has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Outlook - Myomo shares have declined approximately 21% since the beginning of the year, contrasting with the S&P 500's gain of 21.2% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.01 on revenues of $9.45 million, and for the current fiscal year, it is -$0.18 on revenues of $28.62 million [7] - The estimate revisions trend for Myomo is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Products industry, to which Myomo belongs, is currently ranked in the top 36% of over 250 Zacks industries, suggesting that companies in the top 50% outperform those in the bottom 50% by more than 2 to 1 [8]

Revenue Performance - Revenue for the third quarter of 2024 was $9.2 million, up 81% compared to the third quarter of 2023[2] - Product revenue increased 83% year-over-year, driven by a record 161 MyoPro units sold, up 35%[4] - Product revenue for the three months ended September 30, 2024, was $9,207,586, a 83.3% increase from $5,029,523 in the same period of 2023[19] - The company expects fourth quarter revenue to be in the range of $9.5 million to $10.5 million, raising full-year revenue guidance to $30 million to $31 million[11] Patient and Order Metrics - The patient pipeline reached 1,263 patients, an increase of 21% year-over-year, with 645 new candidates added in the third quarter, up 69%[9] - Backlog of orders and insurance authorizations was a record 316 units, up 71% compared to the same period last year[2] Financial Performance - Gross margin for the third quarter was 75.4%, an increase of 670 basis points from 68.7% in the same quarter of 2023[5] - Adjusted EBITDA for the third quarter was $(0.6) million, an improvement from $(1.7) million in the same quarter of 2023[8] - Net loss for the nine months ended September 30, 2024, was $5,923,648, compared to a net loss of $5,687,461 for the same period in 2023[22] - Adjusted EBITDA for the nine months ended September 30, 2024, was $(5,294,458), compared to $(4,886,541) for the same period in 2023[23] Operating Expenses - Operating expenses for the third quarter were $7.9 million, a 43% increase compared to the third quarter of 2023[6] - Operating expenses for the three months ended September 30, 2024, totaled $7,903,108, up from $5,513,217 in the same period of 2023, indicating a 43.4% increase[19] - Research and development expenses for the three months ended September 30, 2024, were $1,248,870, compared to $717,256 in the same period of 2023, reflecting a 74.1% increase[19] Cash and Assets - Cash, cash equivalents, and restricted cash as of September 30, 2024, were $7.0 million, with cash used in operating activities at $1.5 million for the third quarter[10] - Cash and cash equivalents at the end of the period were $6,997,675, slightly up from $6,911,747 at the end of the same period in 2023[22] - Total current assets increased to $14,704,144 as of September 30, 2024, from $13,650,983 at December 31, 2023, reflecting an 7.7% growth[21] - Total liabilities rose to $7,020,537 as of September 30, 2024, compared to $5,592,218 at December 31, 2023, marking a 25.5% increase[21] Shareholder Information - The company reported a weighted average number of common shares outstanding of 37,950,515 for the three months ended September 30, 2024, compared to 35,266,361 for the same period in 2023[19] Strategic Initiatives - The company launched its orthotics and prosthetics channel program in September 2024, aiming for growth in this area in 2025 and beyond[2]