Financial Data and Key Metrics Changes - Revenue in Q1 2025 was $52.6 million, representing a 3% growth compared to Q1 2024, and adjusted for one less selling day, growth was 4.5% [4][8][16] - Gross margin was 79.7% in Q1 2025, down from 80.2% in Q1 2024 [17] - Net loss for Q1 2025 was $15.9 million or $0.25 per share, an improvement from a net loss of $18.7 million or $0.30 per share in Q1 2024 [17] - Adjusted EBITDA loss for Q1 2025 was $3.8 million, compared to $8.3 million in Q1 2024, marking a 54% improvement [17][18] - Cash and cash equivalents were $76.1 million as of March 31, 2025, compared to $75.7 million as of December 31, 2024 [18] Business Line Data and Key Metrics Changes - The company has established a strong customer base of over 3,100 surgeon users and treated over 130,000 patients, leading to over $200 million in revenue [9] - The upcoming commercialization of three new bunion correction systems is expected to target the remaining 75% of surgeon cases [10] Market Data and Key Metrics Changes - The company anticipates substantial growth in Q4 2025, driven by new product availability and seasonal strength from patient deductibles [14][19] - The company expects revenue for 2025 to be between $224 million and $230 million, reflecting a growth of 7% to 10% over 2024 [14][19] Company Strategy and Development Direction - The company aims to evolve from a single technology lapoplasty company to a comprehensive bunion solutions provider [9] - The introduction of new technologies, including the IntelliGuide PSI and SpeedPlate MicroQuad implant, is part of the strategy to enhance product offerings [11][12] - The company plans to launch a next-generation lapoplasty platform, the Lightning system, later in the year [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the impact of new systems on business growth starting in the second half of the year [11] - The company is focused on improving operational efficiencies and reducing cash burn by approximately 50% in 2025 [20][59] Other Important Information - The company has limited tariff exposure, with most inventory manufactured in the U.S., and expects this to remain immaterial in 2026 [20] Q&A Session Summary Question: How does the company feel about its positioning in the bunion market with increased competition? - Management believes lapoplasty remains the superior option and is well-positioned to drive growth with new innovative technologies [24][25] Question: Are there changes in how quickly new surgeon users are being trained? - There has been strong interest in training programs, indicating excitement among surgeons about the new systems [27][28] Question: What explains the expected sales for Q2 being below market expectations? - Management noted that elective procedures have been pushed out, but they expect surgeries to occur later in the year, benefiting from new product launches [36][37] Question: What is the expectation for lapoplasty volumes versus new MIS osteotomy products? - Management anticipates minimal cannibalization and believes the new systems will fill gaps in the current offerings [41][42] Question: How might the step-up in hospital outpatient ASC reimbursement impact performance? - While it's early to quantify the impact, management views it positively and expects it to benefit the business [46][47]

[Special Note Regarding Forward-Looking Statements](index=4&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) This section outlines forward-looking statements and key risks that could cause actual results to differ materially - The report contains forward-looking statements about **business growth**, **profitability**, **market share**, **product development**, and **financial performance**, identifiable by terms like "anticipate," "expect," "will," and "may"[10](index=10&type=chunk) - Key factors that could cause actual results to differ materially include extensive competition, economic conditions, regulatory changes, intellectual property disputes, and the ability to retain and recruit key personnel[11](index=11&type=chunk)[12](index=12&type=chunk)[15](index=15&type=chunk) [Part I: Financial Information](index=6&type=section&id=Part%20I%3A%20Financial%20Information) [Item 1. Condensed Financial Statements](index=6&type=section&id=Item%201.%20Condensed%20Financial%20Statements) This section presents the company's unaudited condensed financial statements and detailed notes for the specified periods [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) This section summarizes the company's condensed balance sheets as of March 31, 2025, and December 31, 2024 Condensed Balance Sheet Highlights (in thousands) | Metric | March 31, 2025 | December 31, 2024 | Change (vs. Dec 31, 2024) | | :-------------------------------- | :------------- | :---------------- | :------------------------ | | Total Assets | $205,846 | $217,094 | $(11,248) | | Total Liabilities | $100,505 | $104,202 | $(3,697) | | Total Stockholders' Equity | $105,341 | $112,892 | $(7,551) | | Cash and cash equivalents | $13,372 | $11,350 | $2,022 | | Marketable securities, short-term | $62,717 | $64,327 | $(1,610) | | Accounts receivable, net | $31,110 | $40,803 | $(9,693) | | Inventories | $37,940 | $39,255 | $(1,315) | | Total current assets | $149,437 | $161,402 | $(11,965) | | Total current liabilities | $33,180 | $34,925 | $(1,745) | | Long-term debt, net | $53,380 | $53,306 | $74 | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's condensed statements of operations and comprehensive loss for Q1 2025 and Q1 2024 Condensed Statements of Operations Highlights (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | % Change (YoY) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :----------- | :------------- | | Revenue | $52,570 | $51,108 | $1,462 | 2.9% | | Cost of goods sold | $10,677 | $10,127 | $550 | 5.4% | | Gross profit | $41,893 | $40,981 | $912 | 2.2% | | Sales and marketing expenses | $36,122 | $40,328 | $(4,206) | (10.4)% | | Research and development expenses | $5,562 | $5,259 | $303 | 5.8% | | General and administrative expenses | $15,791 | $14,362 | $1,429 | 9.9% | | Total operating expenses | $57,475 | $59,949 | $(2,474) | (4.1)% | | Loss from operations | $(15,582) | $(18,968) | $3,386 | (17.9)% | | Net loss | $(15,922) | $(18,676) | $2,754 | (14.7)% | | Net loss per share, basic and diluted | $(0.25) | $(0.30) | $0.05 | (16.7)% | [Condensed Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) This section outlines changes in stockholders' equity for the three months ended March 31, 2025 Stockholders' Equity Changes (in thousands) | Metric | Balances at Dec 31, 2024 | Balances at Mar 31, 2025 | Change | | :------------------------------------ | :----------------------- | :----------------------- | :------- | | Total Stockholders' Equity | $112,892 | $105,341 | $(7,551) | | Net loss | $(15,922) | N/A | N/A | | Share-based compensation expense | $8,693 | N/A | N/A | | Treasury stock (shares withheld for tax) | $(401) | N/A | N/A | [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section presents the company's condensed statements of cash flows for Q1 2025 and Q1 2024 Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | Net cash provided by (used in) operating activities | $4,198 | $(7,221) | $11,419 | | Net cash provided by (used in) investing activities | $(1,894) | $3,758 | $(5,652) | | Net cash provided by (used in) financing activities | $(282) | $(185) | $(97) | | Net increase (decrease) in cash and cash equivalents | $2,022 | $(3,648) | $5,670 | | Cash and cash equivalents at end of period | $13,372 | $9,334 | $4,038 | [Notes to Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides detailed notes to the condensed financial statements, explaining accounting policies and specific components [1. Formation and Business of the Company](index=10&type=section&id=1.%20Formation%20and%20Business%20of%20the%20Company) This note describes the company's specialization in the Lapiplasty® 3D Bunion Correction System and product expansion - The company specializes in the Lapiplasty® **3D Bunion Correction System**, designed to surgically correct bunion deformities across three anatomical planes and address the root cause[29](index=29&type=chunk) - The company is expanding its product offerings to become a comprehensive bunion solutions company and further penetrate the bunion market[29](index=29&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the preparation of interim financial statements and significant accounting estimates and assumptions - The unaudited interim condensed financial statements are prepared in accordance with U.S. GAAP for interim financial information and SEC rules for Form 10-Q[30](index=30&type=chunk) - The company operates as a single reportable segment, focusing on designing, manufacturing, and marketing medical devices for bunion and related midfoot deformities[38](index=38&type=chunk) - Significant estimates and assumptions include valuation of intangible assets and goodwill, reserves for accounts receivable and inventories, and stock-based compensation[34](index=34&type=chunk) [3. Recent Accounting Pronouncements](index=11&type=section&id=3.%20Recent%20Accounting%20Pronouncements) This note details the adoption of ASU 2023-07 and the evaluation of other recent accounting pronouncements - The company adopted ASU 2023-07, Segment Reporting, on **January 1, 2024**, which requires enhanced disclosures for reportable segments[39](index=39&type=chunk) - The company is currently evaluating the impact of ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation Disclosures), effective for annual periods beginning after **December 15, 2024**, and **December 15, 2026**, respectively[40](index=40&type=chunk)[41](index=41&type=chunk) [4. Fair Value Measurements](index=12&type=section&id=4.%20Fair%20Value%20Measurements) This note presents assets measured at fair value and their categorization into Level 1 and Level 2 inputs Assets Measured at Fair Value (in thousands) | Asset Category | March 31, 2025 (Total) | December 31, 2024 (Total) | | :------------------------------------ | :----------------------- | :------------------------ | | Cash equivalents (Money market funds, Corporate debt) | $5,299 | $5,995 | | Short-term marketable securities (U.S. treasury, Corporate debt, Asset-backed, Yankee CD) | $62,717 | $64,327 | | **Total Assets at Fair Value** | **$68,016** | **$70,322** | - Assets and liabilities measured at fair value are categorized into **Level 1** (unadjusted quoted prices in active markets) and **Level 2** (observable inputs other than Level 1 prices)[42](index=42&type=chunk)[43](index=43&type=chunk) [5. Balance Sheet Components](index=14&type=section&id=5.%20Balance%20Sheet%20Components) This note provides detailed breakdowns of cash, marketable securities, property and equipment, and accrued liabilities Cash and Cash Equivalents (in thousands) | Category | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Cash | $8,073 | $5,355 | | Money market funds | $4,101 | $4,798 | | Corporate debt | $1,198 | $1,197 | | **Total** | **$13,372** | **$11,350** | Marketable Securities – Short-term (in thousands) | Category | March 31, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :------------------------------------ | :---------------------------- | :---------------------------- | | U.S. treasury and government agencies | $13,515 | $10,008 | | Corporate debt | $26,456 | $32,269 | | Asset-backed securities | $16,674 | $14,781 | | Yankee CD | $6,072 | $6,774 | | **Total** | **$62,717** | **$64,327** | Property and Equipment, Net (in thousands) | Category | March 31, 2025 | December 31, 2024 | | :------------------------------------ | :------------- | :---------------- | | Total property and equipment | $44,683 | $41,258 | | Less: accumulated depreciation and amortization | $(17,554) | $(15,305) | | **Property and equipment, net** | **$27,129** | **$25,953** | Accrued Liabilities (in thousands) | Category | March 31, 2025 | December 31, 2024 | | :------------------------------------ | :------------- | :---------------- | | Accrued royalties expense | $1,836 | $2,259 | | Accrued compensation expense for RPM-3D earn-out | $0 | $2,125 | | Other accrued expense | $3,179 | $2,056 | | **Total accrued liabilities** | **$6,008** | **$7,197** | [6. Long-Term Debt](index=16&type=section&id=6.%20Long-Term%20Debt) This note details the company's long-term debt, including the MidCap loan facilities and a legal cost financing agreement Long-Term Debt, Net (in thousands) | Category | March 31, 2025 | December 31, 2024 | | :------------------------------------ | :------------- | :---------------- | | MidCap revolving loan facility | $4,000 | $4,000 | | MidCap term loan facility | $50,000 | $50,000 | | Less: debt discount and issuance costs | $(620) | $(694) | | **Total long-term debt, net** | **$53,380** | **$53,306** | - The MidCap term loan and revolving loan facility are accruing interest at capped rates of **9%** and **7%**, respectively, as of **March 31, 2025**[64](index=64&type=chunk) - The company entered into a legal cost financing agreement on **March 25, 2025**, to defer up to **$5.0 million** in legal costs related to a patent dispute with Stryker, bearing **10% interest** per annum[66](index=66&type=chunk) [7. Commitments and Contingencies](index=18&type=section&id=7.%20Commitments%20and%20Contingencies) This note discusses royalty expenses, a shareholder class action, and a patent infringement lawsuit against Stryker - Royalty expense for the three months ended **March 31, 2025**, was **$1.6 million** (**3.1%** aggregate royalty rate), compared to **$1.7 million** (**3.4%**) in the same period of **2024**[68](index=68&type=chunk) - A shareholder class action complaint was filed on **April 11, 2025**, alleging federal securities law violations by the company and certain officers, currently in the preliminary stage[72](index=72&type=chunk) - The company filed a patent infringement lawsuit against Stryker Corporation on **October 14, 2024**, alleging infringement of **9 patents** related to its Lapiplasty® **3D Bunion Correction®** technologies[90](index=90&type=chunk)[133](index=133&type=chunk) [8. Stockholders' Equity](index=20&type=section&id=8.%20Stockholders%27%20Equity) This note provides details on equity awards granted and share-based compensation expense for Q1 2025 and Q1 2024 Equity Awards Granted (Q1 2025 vs. Q1 2024) | Award Type | Q1 2025 (Units) | Q1 2025 (Avg. Fair Value) | Q1 2024 (Units) | Q1 2024 (Avg. Fair Value) | | :-------------------- | :-------------- | :------------------------ | :-------------- | :------------------------ | | Restricted Stock Units (RSUs) | 1,938,595 | $9.33 | 1,426,015 | $13.39 | | Performance Share Units (PSUs) | 560,625 | $11.17 | 453,375 | $18.89 | Share-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Cost of goods sold | $99 | $90 | | Sales and marketing expense | $1,414 | $1,697 | | Research and development expense | $1,125 | $1,006 | | General and administrative expense | $6,055 | $4,615 | | **Total** | **$8,693** | **$7,408** | [9. Net Loss Per Share Attributable to Common Stockholders](index=21&type=section&id=9.%20Net%20Loss%20Per%20Share%20Attributable%20to%20Common%20Stockholders) This note presents the calculation of net loss per share and discusses potentially dilutive securities Net Loss Per Share (Basic and Diluted) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net loss | $(15,922) | $(18,676) | | Weighted-average common stock outstanding | 62,661,447 | 61,792,788 | | **Net loss per share, basic and diluted** | **$(0.25)** | **$(0.30)** | - Potentially dilutive securities, totaling **14.7 million shares** as of **March 31, 2025**, were excluded from diluted EPS calculation due to the company's **net loss**[80](index=80&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section reviews the company's business, financial performance, and outlook, highlighting product innovation, competition, and liquidity [Overview](index=22&type=section&id=Overview) This section provides an overview of the company's medical technology focus, product innovations, and financial position - The company is a medical technology firm focused on surgical management of bunion and midfoot deformities, known for its proprietary Lapiplasty **3D Bunion Correction System**[82](index=82&type=chunk) - Recently introduced Nanoplasty and Percuplasty Procedures for minimally invasive **3D bunion correction**, expanding into the metatarsal osteotomy segment[82](index=82&type=chunk) Financial Position (as of March 31, 2025, in millions) | Metric | Amount | | :------------------------------------ | :----- | | Cash and cash equivalents | $13.4 | | Marketable securities | $62.7 | | Accumulated deficit | $(205.9) | | Principal outstanding under term loan and revolving loan | $54.0 | [Economic Environment](index=22&type=section&id=Economic%20Environment) This section discusses the impact of inflationary pressures, interest rate changes, and macroeconomic conditions on the company - Inflationary pressures and interest rate changes are expected to result in higher **costs** for the company[85](index=85&type=chunk) - Macroeconomic conditions, including recession fears and reduced consumer confidence, may negatively impact patient demand for elective surgeries[85](index=85&type=chunk) - New U.S. tariff policies are expected to increase inventory **costs** and reduce **gross margins**, though not materially at current rates[85](index=85&type=chunk) [Increased Competition](index=23&type=section&id=Increased%20Competition) This section addresses increased competition from minimally invasive solutions and new Lapidus products impacting growth - The company is experiencing increased competition from the accelerating adoption of minimally invasive osteotomy solutions and new Lapidus products[86](index=86&type=chunk) - This increased competition has, and may continue to, negatively impact the company's **growth rates** and **market share**[86](index=86&type=chunk) [Innovation and Growth](index=23&type=section&id=Innovation%20and%20Growth) This section outlines the company's strategy for long-term revenue growth through investments in new products and R&D - The company expects to continue focusing on long-term **revenue growth** through investments in its business and new products, including sales and marketing and R&D[87](index=87&type=chunk) - New products launched in late **2024** include Nanoplasty™ and Percuplasty™ Systems (minimally-invasive **3D osteotomy**), IntelliGuide™ PSI Cut Guides, Micro-Lapiplasty™ System, Mini-Adductoplasty™ System, and SpeedMTP™ Rapid Compression Implant[89](index=89&type=chunk) - In **Q1 2025**, the company launched the SpeedAkin™ implant and the SpeedPlate™ Micro-Quad implant, with plans to expand commercial availability of new products throughout **2025**[89](index=89&type=chunk) [Intellectual Property Strategy](index=23&type=section&id=Intellectual%20Property%20Strategy) This section details the company's patent portfolio and its patent infringement lawsuit against Stryker Corporation - The company's patent portfolio includes **75 granted U.S. patents**, **26 granted patents** worldwide, and over **150 pending patent applications**[90](index=90&type=chunk) - On **October 14, 2024**, the company filed a lawsuit against Stryker Corporation alleging infringement of **9 patents** related to its Lapiplasty® **3D Bunion Correction®** technologies and unfair competition[90](index=90&type=chunk) [Market Share Growth](index=23&type=section&id=Market%20Share%20Growth) This section discusses strategies for gaining broader acceptance of proprietary procedures and securing facility approvals - **Business growth** depends on gaining broader acceptance of proprietary procedures and systems by surgeons and securing hospital and ambulatory surgery center facility approvals[91](index=91&type=chunk) - The company plans to educate hospitals and facility administrators on the differentiated benefits of its procedures and systems, supported by clinical data, to facilitate access and **sales growth**[91](index=91&type=chunk) - The company expects to operate at a **loss** in the near term and anticipates financing operations through existing **cash**, marketable securities, and expected **revenues**, potentially raising additional debt or equity[91](index=91&type=chunk) [Seasonality](index=25&type=section&id=Seasonality) This section explains the company's seasonal sales patterns, with higher volumes in Q4 and lower volumes in Q1-Q3 - The company experiences seasonality with higher **sales volumes** in the **fourth calendar quarter**, historically accounting for approximately **30% to 40%** of full-year **revenues**[92](index=92&type=chunk) - Lower **sales volumes** are typically observed in the **first calendar quarter** due to resetting annual patient healthcare insurance plan deductibles and adverse weather[92](index=92&type=chunk) - **Sales volumes** also tend to be lower in the **second and third quarters** as elective procedures generally decline during the spring and summer months[92](index=92&type=chunk) [Coverage and Reimbursement](index=25&type=section&id=Coverage%20and%20Reimbursement) This section addresses the dependence on third-party payor reimbursement for product sales, including government and private plans - **Sales** of the company's products depend on third-party payor reimbursement, including government programs (Medicare, Medicaid) and private insurance plans[93](index=93&type=chunk) - Based on **2017 claims data**, private payors covered approximately **63%** of Lapidus cases and **60%** of all bunion surgical cases[93](index=93&type=chunk) - Medicare payment rates for Lapiplasty procedures (CPT 28297 and CPT 28740) are grouped under APC 5114, while multiple tarsometatarsal (TMT) joint fusions (CPT 28730 or CPT 27835) are classified under APC 5115[94](index=94&type=chunk) [Components of Our Results of Operations](index=25&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section defines the components of revenue, cost of goods sold, and operating expenses for the company - **Revenue** is generated from the sale of implant kit systems, single-use sterile instruments, and other complementary products to physicians, surgeons, hospitals, ambulatory surgery centers, and stocking distributors[95](index=95&type=chunk) - **Cost of goods sold** primarily includes **costs** for product purchases from third-party manufacturers, royalties, allocated overhead, shipping, sterilization, packaging, and personnel **costs**, with inventory provisions expensed here[97](index=97&type=chunk) - **Operating expenses** are categorized into Sales and Marketing (personnel, commissions, education, advertising), Research and Development (engineering, clinical studies, regulatory, personnel), and General and Administrative (finance, IT, legal, HR, professional services)[99](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) [Results of Operations (Comparison of the three months ended March 31, 2025 and 2024)](index=27&type=section&id=Results%20of%20Operations%20%28Comparison%20of%20the%20three%20months%20ended%20March%2031%2C%202025%20and%202024%29) This section compares the company's financial performance for Q1 2025 and Q1 2024, highlighting key changes Key Financial Performance (Q1 2025 vs. Q1 2024, in thousands) | Metric | 2025 | 2024 | Change | % Change | | :------------------------------------ | :----- | :----- | :----- | :------- | | Revenue | $52,570 | $51,108 | $1,462 | 2.9% | | Cost of goods sold | $10,677 | $10,127 | $550 | 5.4% | | Gross profit | $41,893 | $40,981 | $912 | 2.2% | | Gross profit margin | 79.7% | 80.2% | (0.5)% | (0.6)% | | Sales and marketing expenses | $36,122 | $40,328 | $(4,206) | (10.4)% | | Research and development expenses | $5,562 | $5,259 | $303 | 5.8% | | General and administrative expenses | $15,791 | $14,362 | $1,429 | 9.9% | | Loss from operations | $(15,582) | $(18,968) | $3,386 | (17.9)% | | Net loss | $(15,922) | $(18,676) | $2,754 | (14.7)% | - The **decrease** in **sales and marketing expenses** was primarily due to a **$3.7 million reduction** in advertising spend for direct-to-consumer campaigns and a **$3.5 million decrease** in payroll and related **costs** from optimizing the sales force structure[107](index=107&type=chunk) - Interest income **decreased** by **$0.7 million**, or **45.2%**, primarily due to lower balances invested in marketable securities and slightly lower interest rates[110](index=110&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's liquidity position, capital requirements, and cash flow activities for Q1 2025 Liquidity Position (as of March 31, 2025, in millions) | Metric | Amount | | :------------------------------------ | :----- | | Cash and cash equivalents | $13.4 | | Marketable securities | $62.7 | | Outstanding principal under term and revolving loans | $54.0 | - Management believes existing **cash**, **cash equivalents**, marketable securities, available debt borrowings, and expected **revenues** will be sufficient to meet capital requirements and fund operations for at least the next twelve months[112](index=112&type=chunk)[114](index=114&type=chunk) - **Net cash provided by operating activities** was **$4.2 million** for **Q1 2025**, a significant improvement from **$7.2 million** used in **Q1 2024**, driven by a reduced **net loss** and favorable changes in operating **assets** and **liabilities**[116](index=116&type=chunk)[117](index=117&type=chunk) - **Net cash used in investing activities** was **$1.9 million** for **Q1 2025**, primarily for purchases of marketable securities and property and equipment, while **net cash used in financing activities** was **$0.3 million**, mainly for **shares** repurchased for tax withholding on vested RSUs[118](index=118&type=chunk)[120](index=120&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section confirms no material changes to market risk information from the previously disclosed Annual Report on Form 10-K - There have been no material changes from the market risk information previously disclosed in the Annual Report on Form 10-K[127](index=127&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of **March 31, 2025**, providing reasonable assurance for timely and accurate information disclosure[127](index=127&type=chunk) - No material changes in internal control over financial reporting were identified during the period covered by this Quarterly Report[128](index=128&type=chunk) - Management acknowledges the inherent limitations of any control system, which can only provide reasonable, not absolute, assurance against errors and fraud[129](index=129&type=chunk) [Part II: Other Information](index=32&type=section&id=Part%20II%3A%20Other%20Information) [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) This section details a federal securities class action lawsuit and a patent infringement lawsuit filed against Stryker - A shareholder class action complaint was filed on **April 11, 2025**, alleging federal securities law violations by the company and certain officers, currently in the preliminary stage with an amended complaint filed on **April 28, 2025**[132](index=132&type=chunk) - The company filed a lawsuit against Stryker Corporation on **October 14, 2024**, alleging infringement of **9 patents** related to its Lapiplasty® **3D Bunion Correction®** technologies and unfair competition[133](index=133&type=chunk) - Management disputes the allegations in the class action complaint and intends to defend vigorously, with the outcome remaining uncertain and no estimable potential impact on financial statements at this time[132](index=132&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section confirms no material changes to the risk factors previously disclosed in the Annual Report on Form 10-K - There have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended **December 31, 2024**[134](index=134&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the repurchase of 52,605 common shares at an average price of $7.62, primarily for tax withholding Issuer Purchases of Equity Securities (Three Months Ended March 31, 2025) | Period | Total Number of Shares Purchased | Average Price Paid Per Share | | :------------------------------------ | :----------------------------- | :--------------------------- | | January 1 to January 31, 2025 | 34,685 | $7.30 | | February 1 to February 28, 2025 | — | — | | March 1 to March 31, 2025 | 17,920 | $8.23 | | **Totals** | **52,605** | **$7.62** | - The repurchases primarily include restricted **shares** withheld from employees to offset tax withholding obligations that occur upon vesting and release of restricted **shares**[136](index=136&type=chunk)[137](index=137&type=chunk) [Item 3. Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms no defaults upon senior securities were reported during the period - No defaults upon senior securities were reported[138](index=138&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[139](index=139&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) No other information is reported under this item - No other information to report[140](index=140&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including credit agreement amendments and officer certifications - Includes Amendment No. **2** to Credit and Security Agreement (Revolving Loan) and Amendment No. **2** to Credit and Security Agreement (Term Loan) dated **April 24, 2025**[141](index=141&type=chunk) - Contains certifications from the Principal Executive Officer (John T. Treace) and Principal Financial Officer (Mark L. Hair) as Exhibits **31.1**, **31.2**, **32.1**, and **32.2**[141](index=141&type=chunk) [Signatures](index=33&type=section&id=Signatures) The Quarterly Report was officially signed on May 8, 2025, by the Chief Executive Officer and Chief Financial Officer - The report was signed by John T. Treace, Chief Executive Officer, and Mark L. Hair, Chief Financial Officer, on **May 8, 2025**[147](index=147&type=chunk)

Exhibit 99.1 Treace Medical Concepts Reports First Quarter 2025 Financial Results PONTE VEDRA, Fla. – May 8, 2025 – Treace Medical Concepts, Inc. ("Treace" or the "Company") (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty ® Procedures, today reported financial results for the first quarter ended March 31, 2025 Recent Highlights "We are pleased with the positive c ...

PONTE VEDRA, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. ("Treace" or the "Company") (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty® Procedures, today reported financial results for the first quarter ended March 31, 2025. Recent Highlights Generated revenue of $52.6 million in first quarter 2025 representing growth of 3% over the same pe ...

NEW YORK, May 8, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Treace Medical Concepts, Inc. (NASDAQ: TMCI).Shareholders who purchased shares of TMCI during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/treace-medical-concepts-inc-loss-submission-form-2/?id=147316&from=4CLASS PER ...

Core Viewpoint - Treace Medical Concepts, Inc. is facing a class action lawsuit due to allegations of issuing materially false and misleading statements regarding its primary product, the 3D bunion correction system, "Lapiplasty" [3]. Summary by Relevant Sections Company Performance - The lawsuit claims that competition negatively affected the demand and utilization of Treace Medical's primary product, leading to a decline in revenue [3]. - The company was required to expedite plans for an alternative product to osteotomy due to the declining performance of its existing offerings [3]. Legal Proceedings - The class period for the lawsuit is defined as May 8, 2023, to May 7, 2024 [3]. - Shareholders who purchased shares during this period are encouraged to register for participation in the class action, with a deadline set for June 10, 2025 [4]. Investor Information - The Gross Law Firm is representing the shareholders and aims to protect the rights of investors who have suffered losses due to the alleged misleading statements by Treace Medical [5]. - Registered shareholders will receive updates through a portfolio monitoring software throughout the lifecycle of the case [4].

Core Viewpoint - Treace Medical Concepts, Inc. is facing a class action lawsuit due to alleged misleading statements and failure to disclose critical information regarding its business performance and product demand during the specified class period [3]. Group 1: Lawsuit Details - The class action lawsuit represents investors who purchased Treace Medical securities between May 8, 2023, and May 7, 2024 [1]. - Investors have until June 10, 2025, to file a lead plaintiff motion [1]. - The lawsuit claims that increased competition negatively impacted the demand for Treace Medical's core product, the Lapiplasty® 3D Bunion Correction System [3]. Group 2: Financial Impact - As a result of the competition, Treace Medical experienced a decline in revenue and was forced to expedite the development of an alternative product to osteotomy [3]. - The lawsuit alleges that the defendants made materially misleading representations about Treace Medical's business operations and future prospects, leading to investor damages when the true facts emerged [3]. Group 3: Legal Support - The Portnoy Law Firm offers complimentary case evaluations for investors seeking to recover losses and provides options for pursuing claims [2][4]. - The firm's founding partner has successfully recovered over $5.5 billion for aggrieved investors in the past [4].

NEW YORK, May 06, 2025 (GLOBE NEWSWIRE) -- Scott+Scott Attorneys at Law LLP (“Scott+Scott”), an international shareholder and consumer rights litigation firm, has filed a securities class action lawsuit in the United States District Court for the Middle District of Florida against Treace Medical Concepts, Inc. (“Treace Medical” or the “Company”) (NASDAQ: TMCI), and certain of its former and current officers and/or directors (collectively, “Defendants”). The Class Action asserts claims under §§10(b) and 20(a ...

Core Viewpoint - A class action securities lawsuit has been filed against Treace Medical Concepts, Inc. due to alleged securities fraud impacting investors between May 8, 2023, and May 7, 2024 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Treace Medical's primary product, the 3D bunion correction system "Lapiplasty," faced decreased demand due to competition [2]. - It is alleged that Treace Medical's revenue declined, prompting the company to expedite plans for an alternative product to osteotomy [2]. - Defendants are accused of making misleading positive statements regarding the company's business and prospects, lacking a reasonable basis [2]. Group 2: Investor Information - Investors who suffered losses during the specified timeframe have until June 10, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Legal Firm Background - Levi & Korsinsky, LLP has a history of securing significant settlements for shareholders and is recognized as one of the top securities litigation firms in the U.S. [4].

If you purchased or acquired Treace Medical securities, and/or would like to discuss your legal rights and options please visit Treace Medical Concepts, Inc. Shareholder Class Action Lawsuit or contact Investor Relations Manager Peter Allocco at (212) 951-2030 or pallocco@bernlieb.com. According to the Complaint, Defendants made misrepresentations concerning the impact of competition on demand for, and utilization of, the Company's primary product, the Lapiplasty 3D Bunion Correction System. If you wish to ...