Myomo (MYO) 2025 Investor Day Summary Company Overview - Myomo is focused on developing assistive technology for individuals with paralysis, particularly through their product, MyoPro, which is a myoelectric orthosis designed to help users regain movement in paralyzed arms [7][8][10]. Key Industry Insights - The company operates in the medical device industry, specifically within the orthotics and prosthetics sector, addressing a significant unmet need for patients with chronic arm paralysis [7][8]. - Myomo has established a direct provider business model, which allows them to bring their products directly to patients, enhancing accessibility and support [8][9]. Financial Performance and Goals - Myomo aims to achieve $100 million in revenue by 2028, building on a decade of consistent revenue growth [10]. - The company reported a gross margin of 70%, with potential for improvement as they scale operations [8]. Market Position and Strategy - Myomo has a first-mover advantage in the myoelectric orthosis market, particularly after receiving CMS reimbursement, which opens the market to Medicare-age patients in the U.S. [8][9]. - The revenue breakdown for Q1 indicates that 79% of revenue came from direct billing, 3% from the VA, and 13% from international sales, with plans to grow the O&P clinical channel [9][10]. Marketing and Lead Generation - The marketing strategy includes TV advertising, digital marketing, and clinical referrals, with a focus on reducing the cost per pipeline acquisition [31][32]. - The company utilizes a call center in Fort Worth, Texas, to handle inbound and outbound calls, aiming to efficiently convert leads into patients [56][60]. Patient Journey and Fulfillment Process - The patient journey begins with lead generation, followed by telehealth screenings to assess eligibility, and then moves to the fulfillment stage where custom devices are fabricated [19][25][94]. - The fulfillment process is complex, requiring precise measurements and customization for each patient, which is critical for the effectiveness of the MyoPro device [97][98]. Challenges and Considerations - The company faces challenges related to patient eligibility, as not all patients qualify for the MyoPro due to varying clinical conditions [69][70]. - There is a need for continuous education and awareness among patients, therapists, and physicians to ensure proper understanding and utilization of the MyoPro [22][23]. Leadership and Team Structure - The leadership team includes experienced professionals from various backgrounds, emphasizing a commitment to patient care and innovative solutions [11][12]. - The company is structured to allow for efficient scaling of operations, particularly in the intake and telehealth screening processes [63][66]. Conclusion - Myomo is well-positioned to capitalize on the growing demand for assistive technologies for individuals with paralysis, with a clear strategy for growth and a strong focus on patient outcomes and satisfaction [7][10].

Company Performance - Myomo, Inc. reported a quarterly loss of $0.08 per share, which aligns with the Zacks Consensus Estimate, an improvement from a loss of $0.10 per share a year ago [1] - The company posted revenues of $9.83 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 6.29%, compared to revenues of $3.75 million in the same quarter last year [2] - Over the last four quarters, Myomo has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2][3] Stock Outlook - Myomo shares have declined approximately 25.9% since the beginning of the year, contrasting with the S&P 500's decline of 4.7% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.06 on revenues of $10.35 million, and for the current fiscal year, it is -$0.07 on revenues of $50.95 million [7] Industry Context - The Medical - Products industry, to which Myomo belongs, is currently ranked in the bottom 28% 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 could impact Myomo's stock performance [5][6]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $9,800,000, representing a 162% increase year over year, driven by a higher number of revenue units and an increased average selling price (ASP) [20][21] - The company delivered 182 MyoPro revenue units in Q1, up 100% from the previous year, with ASP increasing by approximately 31% to around $54,000 [11][21] - Gross margin for Q1 2025 was 67.2%, compared to 61.2% in the prior year, primarily due to a higher ASP and better fixed cost absorption [26] - Operating loss for Q1 2025 was $3,500,000, a 9% improvement from a loss of $3,900,000 in Q1 2024 [27][28] Business Line Data and Key Metrics Changes - The O and P revenue was $475,000 in Q1, up 87% year over year, but down sequentially due to seasonality [14] - The international business, primarily in Germany, generated over $1,300,000 in revenue, representing a 42% year-over-year increase [11][22] Market Data and Key Metrics Changes - Medicare Part B patients accounted for 60% of total revenue in Q1, up from 57% in the previous quarter, indicating strong growth in this segment [11][21] - Medicare Advantage revenue represented 17% of Q1 revenue, reflecting an 18% year-over-year increase, although growth is lagging due to high denial rates [21][22] Company Strategy and Development Direction - The company is focused on continuous innovation, having launched the MyoPro 2X and the Mark II clinical unit, aimed at enhancing patient independence and expanding the O and P distribution channel [6][7] - Plans for further expansion include increasing manufacturing capacity and enhancing marketing efforts to drive lead generation and patient engagement [12][32] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in lead generation due to changes in social media advertising policies but reported a rebound in lead generation in March and April [10][32] - The company expects Q2 revenue to be slightly lower than Q1 but reaffirms its financial targets for the year, projecting full-year revenue between $50,000,000 and $53,000,000, representing growth of 54% to 66% over 2024 [30][31] Other Important Information - The company has signed contracts covering approximately 25,000,000 lives, including several new state Blue Cross Blue Shield plans, and is negotiating with national health insurance plans [18][64] - The company is actively working to improve insurance access and reduce denial rates through advocacy and legal engagement [17][65] Q&A Session Summary Question: Can you elaborate on the workaround around the Meta issue affecting advertising efficiency? - Management indicated that changes in Meta's algorithms impacted ad targeting, but adjustments made with their agency have led to a record number of leads in April, suggesting sustainability in improvements [37][38] Question: What is the expected cost per pipeline add moving forward? - The cost per lead in April was approximately half of that in January and February, with expectations to maintain efficiency around $1,400 to $1,500 for the year [39][40] Question: How does the authorization rate for the pipeline look? - The authorization rate was affected by backend loading of pipeline adds and high denial rates from Medicare Advantage plans, which are currently around 30% [51][52] Question: What is the outlook for gross margins going forward? - Management expects slightly lower gross margins in Q2 due to lower volume but anticipates approaching 70% gross margins in the second half of the year [53] Question: What is the confidence level in achieving the full-year guidance? - Management reiterated confidence in achieving full-year guidance, citing historical revenue patterns and increased advertising efforts to fill the pipeline [56]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $9,800,000, representing a 162% increase year over year, driven by a higher number of revenue units and an increased average selling price (ASP) [18][19] - The company delivered 182 MyoPro revenue units in Q1, up 100% from Q1 2024, with ASP increasing by approximately 31% to around $54,000 [19][9] - Gross margin for Q1 2025 was 67.2%, compared to 61.2% in the prior year quarter, primarily due to a higher ASP and better fixed cost absorption [24] - Operating loss for Q1 2025 was $3,500,000, a decrease of 9% compared to the $3,900,000 loss in Q1 2024 [25][26] Business Line Data and Key Metrics Changes - The O and P revenue was $475,000 in Q1, up 87% year over year, but down sequentially due to seasonality [12] - The company added a record 700 medically qualified candidates to its patient pipeline during Q1, ending the quarter with nearly 1,500 patients in the process of obtaining MyoPro [9][20] - International revenue, primarily from Germany, was $1,300,000 in Q1, representing 13% of total revenue and up 42% year over year [19][10] Market Data and Key Metrics Changes - Medicare Part B patients represented 60% of total revenue in Q1, up from 57% in the previous quarter, highlighting the company's success in educating this patient population [19] - Medicare Advantage revenue was 17% of Q1 revenue, reflecting an 18% year-over-year increase, although growth is lagging due to high denial rates [19][14] Company Strategy and Development Direction - The company is focused on continuous innovation, having launched two product upgrades in 2025, including the MyoPro 2X, aimed at improving independent device use [6][9] - The company is expanding its O and P distribution channel by training clinicians and establishing certified MyoPro centers of excellence [12][11] - The company plans to continue investing in marketing, product development, and distribution channels to achieve cash flow positivity by the end of 2025 [16][28] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in lead generation due to changes in social media algorithms but reported a record number of leads in April, indicating a rebound [8][29] - The company expects Q2 revenue to be slightly lower than Q1 but reaffirms its financial targets for the year, projecting full-year revenue between $50,000,000 and $53,000,000 [28][9] - Management expressed confidence in achieving its guidance for the year, citing a historical trend of higher revenue in the second half of the year [55][28] Other Important Information - The company completed a successful capital raise at the end of 2024 to fund growth plans for 2025 and beyond [16] - The company is actively working to improve insurance access and has signed contracts covering 25,000,000 lives, including several new state Blue Cross Blue Shield plans [16][64] Q&A Session Summary Question: Can you elaborate on the workaround around the Meta issue driving advertising efficiency improvement? - Management explained that changes in Meta's algorithms affected ad targeting, but adjustments made with their agency led to a record number of leads in April, indicating sustainability in improvements [35][36] Question: What is the expected cost per pipeline add moving forward? - Management indicated that while the cost per pipeline add in April was significantly lower than in January and February, they expect it to stabilize around $1,400 to $1,500 for 2024 [37] Question: What are the drivers behind the percentage of pipeline drops? - Management noted that pipeline drops are often due to inability to contact patients again or changes in insurance, with clinical presentation changes also affecting backlog [38][40] Question: How should investors think about revenue cadence in Q3 and Q4? - Management stated that with a higher percentage of Medicare revenue, they do not need as high a backlog for revenue forecasts, and they expect to maintain fill percentages [41][42] Question: Can you provide insights on the O and P channel growth? - Management highlighted the O and P channel as a significant growth opportunity, with good reimbursement and margins, despite challenges in staffing and training [72][73] Question: What is the outlook for international markets, particularly Germany? - Management confirmed plans to expand the team in Germany and increase investments in social media advertising and clinic recruitment due to strong growth in that market [77][78]

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) |

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was a record $12.1 million, representing a 154% increase year-over-year, driven by a higher number of revenue units and a higher average selling price (ASP) [22][11] - Full-year revenue for 2024 totaled $32.6 million, up 69% from 2023, with product revenue increasing 86% when excluding license fees [34] - Gross margin for Q4 2024 was 71.4%, compared to 65.3% in the prior year quarter, primarily due to a higher ASP and better fixed cost absorption [30] - Operating loss for Q4 narrowed to $200,000 from $2.4 million in the prior year quarter, while net loss was $300,000 or $0.01 per share, compared to a net loss of $2.5 million or $0.07 per share in Q4 2023 [32] Business Line Data and Key Metrics Changes - The company delivered 220 MyoPro revenue units in Q4, doubling the volume from Q4 2023, with a total of more than 600 devices sold during the year [11] - O&P revenue grew to $600,000 in Q4, up 94% sequentially, as more clinics began the process of becoming MyoPro centers of excellence [13] - International revenue reached a record $1.5 million in Q4, representing 12% of quarterly revenue, primarily from Germany [27] Market Data and Key Metrics Changes - Medicare Part B patients represented 57% of total revenue in Q4, up from 55% in Q3, indicating success in educating this patient population [25] - The pipeline stood at 1,389 patients at the end of Q4, an increase of 33% year-over-year, with 657 new patients added in Q4 alone, up 72% from the prior year's fourth quarter [28] Company Strategy and Development Direction - The company aims to increase capacity and achieve cash flow breakeven by the end of 2025, with plans to double advertising expenses to over $6 million [10][40] - The strategy includes expanding the O&P distribution channel and establishing contracts with health insurance plans to become an in-network provider [18][19] - The company is committed to innovation, investing in R&D to build the next generation MyoPro platform [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in 2025, expecting revenue to be between $50 million and $53 million, representing growth of 54% to 66% over 2024 [39] - The reimbursement environment is expected to remain consistent, with new contracts being established that could accelerate the revenue cycle [82] - Management highlighted the importance of educating patients and clinicians about MyoPro, anticipating increased demand from Medicare beneficiaries [46] Other Important Information - The company achieved positive adjusted EBITDA for the first time in its history, reaching about $200,000 in Q4 2024 [33] - The company relocated operations to a new facility in Burlington, increasing manufacturing capacity to 120 units per month [20] Q&A Session Summary Question: Can you walk through your assumptions on unit or revenue contribution in 2025 from the O&P channel? - Management indicated that while the direct provider business will continue to be the primary revenue source, they expect meaningful growth from the O&P channel in 2025 [58][60] Question: How quick can you ramp advertising spend and what do you expect from a spend perspective in Q1? - Management noted that they expect a slight increase in the cost per pipeline add in Q1 due to changes in advertising platforms, but they are optimistic about lead generation [62][64] Question: What are the main reasons for authorization denials and how can they be reduced? - Management identified that denials often cite the device as experimental or question medical necessity, and they are actively working to counter these claims through physician documentation and advocacy [104][106] Question: What growth can be expected from the international market in 2025? - Management expressed confidence in continued growth in Germany, where they have a strong presence and are expanding their marketing efforts [111][113]

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]

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was a record $12.1 million, representing a 154% increase year-over-year, driven by a higher number of revenue units and a higher average selling price (ASP) [22][11] - Full-year revenue for 2024 totaled $32.6 million, up 69% from 2023, with product revenue increasing 86% when excluding license fees [34] - Gross margin for Q4 2024 was 71.4%, compared to 65.3% in the prior year quarter, primarily due to a higher ASP and better fixed cost absorption [30] - Operating loss for Q4 narrowed to $200,000 from $2.4 million in the prior year quarter, while net loss was $300,000 or $0.01 per share, compared to a net loss of $2.5 million or $0.07 per share in Q4 2023 [32] Business Line Data and Key Metrics Changes - The company delivered 220 MyoPro revenue units in Q4, doubling the volume from Q4 2023, with a total of more than 600 devices sold during the year [11] - O&P revenue grew to $600,000 in Q4, up 94% sequentially, as more clinics began the process of becoming MyoPro centers of excellence [13] - International revenue reached a record $1.5 million in Q4, representing 12% of quarterly revenue, primarily from Germany [27] Market Data and Key Metrics Changes - Medicare Part B patients represented 57% of total revenue in Q4, up from 55% in Q3, indicating continued success in educating this patient population [25] - The pipeline stood at 1,389 patients at the end of Q4, an increase of 33% year-over-year, with 657 new patients added in Q4 alone, up 72% from the prior year's fourth quarter [28] Company Strategy and Development Direction - The company aims to increase capacity and achieve cash flow breakeven by the end of 2025, with plans to double advertising expenses to over $6 million [10][40] - The strategy includes expanding the O&P distribution channel and establishing contracts with health insurance plans to enhance in-network status [19][18] - The company is committed to innovation, investing in R&D to develop the next generation MyoPro platform [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the reimbursement environment, expecting it to remain consistent or improve, particularly with new contracts and price increases from CMS [82] - The company anticipates continued strong growth in 2025, with revenue guidance set between $50 million and $53 million, representing growth of 54% to 66% over 2024 [39] Other Important Information - The company achieved positive adjusted EBITDA for the first time in its history, reaching about $200,000 in Q4 2024 [33] - The company relocated operations to a new facility in Burlington, increasing manufacturing capacity to 120 units per month [20] Q&A Session Summary Question: Can you walk through your assumptions on unit or revenue contribution in 2025 from the O&P channel? - Management indicated that while revenue will primarily come from the direct provider business, they expect meaningful growth from the O&P channel in 2025 [58][60] Question: How quick can you ramp advertising spend and what do you expect from a spend perspective in Q1? - Management noted that it is too early to determine the efficiency of the cost per pipeline add but expects a slight increase in Q1 [62] Question: What are the main reasons for authorization denials and how can they be reduced? - The main reasons include claims being labeled as experimental or lacking medical necessity, with management actively working to counter these claims [104][105] Question: What growth can be expected from the international market in 2025? - Management expects continued growth in Germany, with over 100 O&P clinical partners trained and a steady track record of growth year-over-year [111][112]

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].