PONTE VEDRA, Fla., Oct. 23, 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, today announced that it will release financial results for the third quarter 2025 after the close of trading on Thursday, November 6, 2025. Company management will host a conference call to discuss financial results beginning at 4:30 pm ET. Investors inter ...

Core Insights - Treace Medical Concepts, Inc. is showcasing new product innovations and presenting interim data from the ALIGN3D and MTA3D clinical studies at the AOFAS Annual Meeting 2025 [1][2] Product Innovations - The company is highlighting the full commercial release of its expanded bunion portfolio, which includes new technologies such as Nanoplasty, Percuplasty, SpeedMTP, and IntelliGuide PSI, aimed at improving surgical outcomes for bunion patients [2][4] - The Nanoplasty procedure allows for 3D minimally invasive osteotomies through a single 1.5cm incision, while Percuplasty utilizes 0.5cm percutaneous incisions for a more efficient approach [4] - SpeedMTP provides a fusion option for bunion patients with arthritic great toe joints, combining advanced fixation technology for stability [4] - IntelliGuide PSI offers personalized 3D-printed cut guides for enhanced surgical workflow [4] Clinical Study Presentations - The ALIGN3D clinical study presented interim data showing early return to weight bearing in an average of 8.4 days and low radiographic recurrence rates of 7.7% at 48 months and 4.8% at 60 months [5][6] - The MTA3D clinical study is assessing outcomes following combined Adductoplasty and Lapiplasty procedures, with interim data showing significant improvements in pain and patient-reported scores at 12 months [7][12] Company Overview - Treace Medical Concepts aims to advance the standard of care for surgical management of bunions and related midfoot deformities, addressing a market of approximately 65 million Americans, with an estimated 1.1 million surgical candidates annually [11] - The company has developed the Lapiplasty 3D Bunion Correction System, which corrects bunion deformities in all three planes and secures the unstable joint [11][13]

Core Insights - Treace Medical is focused on improving bunion surgery and advancing the standard of care in the foot and ankle market [2][3] - The company has a strong leadership team, including experienced surgeons and executives, to drive innovation and commercial success [2][3] Company Background - Treace Medical was founded in 2014 with a mission centered on enhancing patient outcomes in bunion surgery [3] - The company emphasizes its commitment to innovation and leadership in the bunion market [2][3]

Summary of Treace Medical Concepts (TMCI) 2025 Investor Day Company Overview - Treace Medical Concepts was founded in 2014 with a mission to improve outcomes for bunion patients, achieving over $200 million in revenue primarily through a patented bunion procedure [2][3] - The company is entering a new growth phase with a comprehensive bunion solutions portfolio, aiming to address the significant problem of bunions, which can lead to painful and lifestyle-limiting deformities [3][4] Market Opportunity - Currently, Treace Medical has penetrated about 3% of the symptomatic surgical candidate base, with a goal to reach 7% to 8% to double the business in the coming years [3][4] - There are over 1 million symptomatic surgical candidates for bunion surgery, with high recurrence rates (60% to 70%) associated with traditional two-plane surgeries [4][5] - The company believes that its innovative Lapiplasty technology, which allows for comprehensive three-plane bunion correction, fills a significant gap in the market [4][5] Product Innovations - The Lapiplasty system has been adopted by nearly one-third of bunion surgeons by 2025, with ongoing iterations to improve reproducibility and minimize invasiveness [5][6] - New systems being launched include: - Nanoplasty and Percutoplasty 3D MIS osteotomy systems - SpeedMTP Rapid Compression Implant system - These innovations aim to address significant volume segments and expand access to the untapped 70% of surgeons' cases [6][8] Surgical Techniques and Philosophy - Treace Medical emphasizes a philosophy of teaching surgeons how to perform bunion surgeries effectively, which is seen as a key differentiator from competitors [34][35] - The company has developed a classification system for bunion treatment, recognizing four distinct categories of patients [11][12] - The focus is on achieving reproducible, consistent triplanar results with minimal incisions, reducing patient morbidity and improving recovery times [17][18] Competitive Landscape - Treace Medical's approach contrasts with competitors who may not provide adequate training or support for their surgical techniques [34][39] - The SpeedMTP system is highlighted as intuitive and easy to use, making it appealing to both surgeons and patients [40][41] Patient-Centric Approach - The company aims to change the perception of bunion surgery, traditionally viewed as painful and lengthy, by promoting minimally invasive techniques that offer faster recovery and less pain [50][60] - There is a growing demand for these techniques, particularly among patients who have previously avoided surgery due to fear of pain and recovery time [50][51] Conclusion - Treace Medical Concepts is positioned to lead the bunion surgery market with innovative technologies and a strong focus on surgeon education and patient outcomes, aiming to significantly increase market penetration and improve surgical results in the coming years [3][4][5]

Market Opportunity - The US bunion market represents a significant opportunity, with approximately 65 million Americans affected by bunions [9] - Of those affected, 44 million seek medical treatment annually [9] - The current US market for bunion surgical procedures is estimated at $23 billion, with a potential to exceed $5 billion [9] - Approximately 450,000 surgical procedures are performed annually, while an estimated 650,000 additional patients are in need of surgical treatment [9] Treace Medical Concepts' Position - Treace Medical Concepts, Inc is focused on improving outcomes for bunion patients, with a 5-year revenue CAGR of 40% [7] - The company's FY 2024 revenue reached $2094 million, representing a 12% increase, with a gross margin of 80% [7] - Approximately one-third of US foot surgeons are currently using Lapiplasty [7] Technology and Innovation - Treace is the pioneer and leader in 3D bunion surgery, protected by 117 US patents and pending patents [7] - Lapiplasty has demonstrated early weight bearing at an average of 77 days in a walking boot [19] - Lapiplasty has demonstrated 81% pain reduction with 89% improvement in MOxFQ walking/standing scores at 48 months [19] - Lapiplasty has demonstrated low recurrence rates of 08% (HVA >20°) & 84% (HVA >15°) at 48 months [19]

分组1 - Treace Medical Concepts reported a quarterly loss of $0.28 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.29, and an improvement from a loss of $0.34 per share a year ago, resulting in an earnings surprise of +3.45% [1] - The company achieved revenues of $47.39 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 0.79% and showing an increase from $44.46 million in the same quarter last year [2] - Treace Medical Concepts has consistently surpassed consensus EPS estimates over the last four quarters, indicating a positive trend in performance [2] 分组2 - The stock has underperformed the market, losing approximately 26.5% since the beginning of the year, while the S&P 500 has gained 7.9% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.25 on revenues of $49.93 million, and for the current fiscal year, it is -$0.80 on revenues of $226.97 million [7] - The Zacks Industry Rank for Medical - Instruments is in the bottom 41% of over 250 Zacks industries, suggesting that the industry outlook may negatively impact stock performance [8]

Financial Data and Key Metrics Changes - Revenue in Q2 2025 was $47.4 million, representing a 7% increase compared to the same period in 2024 [7][19] - Gross margin decreased to 79.7% in 2025 from 80.2% in 2024 [19] - Total operating expenses were reduced by 4% to $54.7 million in 2025 from $57.1 million in 2024 [19] - Net loss improved to $17.4 million or $0.28 per share, an 18% improvement from a net loss of $21.2 million or $0.34 per share in Q2 2024 [20] - Adjusted EBITDA loss was $3.6 million, significantly improved by 58% compared to $8.7 million in 2024 [20] - Cash usage decreased by 55.78% in Q2 2025 compared to the prior year, supporting a projected 50% reduction in cash used for the full year [21] Business Line Data and Key Metrics Changes - The company expanded its portfolio to include three new bunion correction systems, enhancing its offerings alongside the flagship lapoplasty and adductoplasty systems [7][10] - The new systems are expected to drive procedure penetration and expand market leadership [8][10] Market Data and Key Metrics Changes - The total addressable market (TAM) for the company is estimated at over $5 billion, with approximately 1.1 million annual symptomatic surgical candidates in the U.S. [10] - Current market penetration is approximately 2.8%, indicating significant untapped opportunities [10] Company Strategy and Development Direction - The company's strategy focuses on increasing procedure volumes and expanding its customer base, aiming to penetrate the remaining 70% of bunion-related cases among existing customers [11][12] - The company is also targeting new surgeons who prefer metatarsal osteotomy procedures, leveraging its expanded portfolio to attract this audience [12][13] - The company plans to launch additional products and technologies, including the next-generation Lapaplasty system, to further enhance its market position [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue growth of 7% to 10% for the full year 2025, with expectations for sequential growth in the remaining quarters [15][21] - The company anticipates a strong performance in Q3 and Q4, traditionally the strongest quarters, driven by new product launches and increased surgeon engagement [35][41] Other Important Information - The company will host an Investor Day on September 3, 2025, to present its expanded technology portfolio [22] - A recent peer-reviewed publication highlighted successful patient outcomes from the ALIGN3D lapoplasty clinical study, further differentiating the company's offerings in the marketplace [16] Q&A Session Summary Question: Can you provide more quantitative commentary on surgeon profiles for the new systems? - Management expects increasing volumes and revenue contributions from the new systems as they penetrate the market and serve the osteotomy segment [25] Question: What feedback has been received regarding the Lapoplasty Lightning System? - The Lapoplasty Lightning System is anticipated to significantly advance the procedure, with expectations for it to drive growth in 2026 [30] Question: How is the company viewing the foot and ankle market and procedure trends? - Management noted that while some procedures have been pushed out, they do not believe any cases are lost, and they anticipate growth to be back half-weighted [34][35] Question: What is the confidence level in achieving a strong ramp in Q4? - Management expressed confidence in a substantial step-up in revenue and procedure volume in Q4, supported by a full suite of bunion products [41][58] Question: Is there interest in inorganic growth opportunities? - The company is opportunistically looking for inorganic growth opportunities to drive expansion and is also exploring international markets [53]

Special Note Regarding Forward-Looking Statements [Forward-Looking Statements Overview](index=4&type=section&id=Forward-Looking%20Statements%20Overview) This section highlights forward-looking statements about the Company's business, operations, and financial performance, subject to risks and uncertainties - The report contains forward-looking statements concerning business, operations, and financial performance, identifiable by terms like 'anticipate,' 'expect,' 'plan,' and 'will'[10](index=10&type=chunk) - Key forward-looking statements include expectations for product use, business growth, profitability, market share, expense control, new product development, balance sheet strength, seasonality, economic impacts, reimbursement, and intellectual property protection[11](index=11&type=chunk)[15](index=15&type=chunk) - Actual results may differ materially from expectations due to unpredictable events and factors, including those outlined in the Annual Report on Form 10-K and the 'Risk Factors' section of this Quarterly Report[12](index=12&type=chunk) Part I: Financial Information [Item 1. Condensed Financial Statements](index=6&type=section&id=Item%201.%20Condensed%20Financial%20Statements) This section presents Treace Medical Concepts' unaudited condensed financial statements, covering balance sheets, income, equity, and cash flows [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheet Highlights (in millions) | Metric | June 30, 2025 | December 31, 2024 | Change (Absolute) | Change (%) | | :-------------------------------- | :------------ | :---------------- | :---------------- | :--------- | | Total current assets | $147.6 | $161.4 | $(13.8) | -8.55% | | Total assets | $206.4 | $217.1 | $(10.7) | -4.91% | | Total current liabilities | $41.9 | $34.9 | $7.0 | 19.97% | | Total liabilities | $108.8 | $104.2 | $4.6 | 4.44% | | Total stockholders' equity | $97.6 | $112.9 | $(15.3) | -13.53% | - Cash and cash equivalents decreased from **$11.4 million** at December 31, 2024, to **$8.1 million** at June 30, 2025, a decrease of **29.05%**[18](index=18&type=chunk) - Accounts receivable, net, decreased from **$40.8 million** at December 31, 2024, to **$30.3 million** at June 30, 2025, a decrease of **25.67%**[18](index=18&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Statements of Operations and Comprehensive Loss (in millions, except per share) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | YoY Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | YoY Change (%) | | :------------------------------------ | :------------------------------- | :------------------------------- | :------------- | :----------------------------- | :----------------------------- | :------------- | | Revenue | $47.4 | $44.5 | 6.6% | $100.0 | $95.6 | 4.6% | | Gross profit | $37.8 | $35.7 | 5.8% | $79.6 | $76.7 | 3.9% | | Loss from operations | $(17.0) | $(21.4) | -20.6% | $(32.6) | $(40.4) | -19.3% | | Net loss | $(17.4) | $(21.2) | -18.0% | $(33.3) | $(39.9) | -16.5% | | Net loss per share, basic and diluted | $(0.28) | $(0.34) | -17.6% | $(0.53) | $(0.64) | -17.1% | - Sales and marketing expenses decreased by **12.2%** for the three months ended June 30, 2025, and by **11.3%** for the six months ended June 30, 2025, compared to the same periods in 2024[20](index=20&type=chunk) - General and administrative expenses increased by **13.5%** for the three months and **11.7%** for the six months ended June 30, 2025, compared to the same periods in 2024[20](index=20&type=chunk) [Condensed Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) Changes in Stockholders' Equity (in millions) | Item | December 31, 2024 | June 30, 2025 | | :------------------------------------ | :---------------- | :------------ | | Total Stockholders' Equity | $112.9 | $97.6 | | Accumulated Deficit | $(190.0) | $(223.3) | | Additional Paid-In Capital | $303.0 | $321.5 | | Common Stock Outstanding Shares | 62,361,710 | 63,042,314 | - Net loss for the six months ended June 30, 2025, was **$(33.3) million**, contributing to the accumulated deficit[23](index=23&type=chunk) - Share-based compensation expense totaled **$18.3 million** for the six months ended June 30, 2025, increasing additional paid-in capital[23](index=23&type=chunk) [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statements of Cash Flows (in millions) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash provided by (used in) operating activities | $1.1 | $(21.1) | | Net cash provided by (used in) investing activities | $(5.2) | $26.2 | | Net cash provided by (used in) financing activities | $0.7 | $0.1 | | Net increase (decrease) in cash and cash equivalents | $(3.3) | $5.2 | | Cash and cash equivalents at end of period | $8.1 | $18.2 | - Operating activities generated **$1.1 million** in cash for the six months ended June 30, 2025, a significant improvement from a **$21.1 million** cash usage in the prior year period[26](index=26&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - Investing activities used **$5.2 million** in cash for the six months ended June 30, 2025, primarily due to purchases of marketable securities and property and equipment, contrasting with a **$26.2 million** cash generation in the prior year[26](index=26&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) [Notes to Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) [1. Formation and Business of the Company](index=10&type=section&id=1.%20Formation%20and%20Business%20of%20the%20Company) Treace Medical Concepts, Inc. is a medical technology company focused on surgical management of bunion and midfoot deformities - Treace Medical Concepts, Inc. is a medical technology company focused on advancing surgical management of bunion and related midfoot deformities[28](index=28&type=chunk) - The company pioneered the Lapiplasty® 3D Bunion Correction System, which corrects bunion deformities across three planes and secures the unstable joint[28](index=28&type=chunk) - Product offerings have expanded to become a comprehensive bunion solutions company, further penetrating the bunion market[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the company's significant accounting policies, including adherence to U.S. GAAP and SEC regulations for interim financial reporting - The unaudited interim condensed financial statements adhere to U.S. GAAP for interim financial information and SEC regulations for Form 10-Q[29](index=29&type=chunk) - Management makes estimates and assumptions affecting reported amounts, which may materially differ from actual results[32](index=32&type=chunk) - The company operates as a single reportable segment, focusing on medical devices for bunion and midfoot deformities[37](index=37&type=chunk) [3. Recent Accounting Pronouncements](index=11&type=section&id=3.%20Recent%20Accounting%20Pronouncements) The company is evaluating the impact of new accounting standards, ASU 2023-09 and ASU 2024-03, on its financial statements and disclosures - ASU 2023-09 (Income Taxes) requires public entities to disclose specific categories in rate reconciliation and additional information for material reconciling items, effective for annual periods beginning after December 15, 2024[39](index=39&type=chunk) - ASU 2024-03 (Expense Disaggregation Disclosures) mandates tabular disclosure of certain natural expenses (inventory purchases, employee compensation, depreciation, intangible asset amortization) and qualitative descriptions for remaining captions, effective for annual periods beginning

Executive Summary & Recent Highlights Treace Medical Concepts reported solid Q2 2025 financial results with revenue growth and improved profitability, alongside significant strategic advancements in its 3D bunion solutions portfolio [Overview of Q2 2025 Performance](index=1&type=section&id=Overview%20of%20Q2%202025%20Performance) Treace Medical Concepts reported solid financial results for Q2 2025, with revenue growth and significant improvements in net loss and Adjusted EBITDA loss compared to the prior year, highlighting progress in addressing surgeon and patient needs with its expanded portfolio of 3D bunion solutions - The second quarter was marked by solid progress in expanding the portfolio of 3D bunion solutions and strong financial results[3](index=3&type=chunk) - Net loss per share improved to **$(0.28)** in Q2 2025 from $(0.34) in Q2 2024[6](index=6&type=chunk) Q2 2025 Key Financial Performance (YoY, in millions) | Metric | Q2 2025 | Q2 2024 | Change (%) | | :--------------------- | :------ | :------ | :--------- | | Revenue | $47.4 | $44.5 | 7% | | Net Loss | $(17.4)| $(21.2)| 18% Improvement | | Adjusted EBITDA Loss | $(3.6) | $(8.7) | 58% Improvement | [Strategic Developments and Product Portfolio Expansion](index=1&type=section&id=Strategic%20Developments%20and%20Product%20Portfolio%20Expansion) Treace achieved significant strategic milestones, including the full market release of three new bunion technologies, publication of four-year clinical data for Lapiplasty® demonstrating long-term positive patient outcomes, and expansion of its global patent portfolio - Full market release of Nanoplasty®, Percuplasty™ 3D MIS Osteotomy Systems, and SpeedMTP® MTP Fusion System in Q3 2025[6](index=6&type=chunk) - Align3D™ four-year clinical data published, distinguishing Lapiplasty® as the only commercial surgical bunion system with four-year multicenter, prospective published data[6](index=6&type=chunk) - Broadened global patent portfolio to **117 granted patents** and **163 pending patent applications**[6](index=6&type=chunk) - Total liquidity as of June 30, 2025, was **$90.7 million**, comprising **$69.3 million** in cash, cash equivalents, and marketable securities, and **$21.4 million** in revolving loan facility availability[7](index=7&type=chunk) - Cash usage decreased by **55% in Q2 2025** and **78% year-to-date** compared to the prior year, supporting an expected **50% reduction** in cash used for full-year 2025[7](index=7&type=chunk) Second Quarter 2025 Financial Review Treace Medical Concepts' Q2 2025 financial review highlights increased revenue, improved net loss, and reduced cash usage, supported by a strong liquidity position and better Adjusted EBITDA performance [Consolidated Statements of Operations](index=1&type=section&id=Consolidated%20Statements%20of%20Operations) Treace Medical Concepts reported a 7% increase in revenue for Q2 2025, reaching $47.4 million, with gross profit also increasing, though gross margin slightly decreased, contributing to an improved net loss and Adjusted EBITDA loss compared to the previous year Q2 2025 vs Q2 2024 Financial Highlights (in thousands) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | YoY Change (%) | | :--------------------- | :--------------------- | :--------------------- | :------------- | | Revenue | $47,387 | $44,455 | 7.0% | | Cost of goods sold | $9,635 | $8,781 | 9.7% | | Gross profit | $37,752 | $35,674 | 5.8% | | Gross margin | 79.7% | 80.2% | (0.5) pp | | Total operating expenses | $54,726 | $57,056 | (4.1)% | | Net loss | $(17,398) | $(21,206) | (18.0)% | | Net loss per share | $(0.28) | $(0.34) | (17.6)% | [Liquidity and Balance Sheet](index=2&type=section&id=Liquidity%20and%20Balance%20Sheet) As of June 30, 2025, Treace maintained a total liquidity of $90.7 million, comprising cash, cash equivalents, marketable securities, and available revolving loan facility, demonstrating improved cash management with a significant reduction in cash usage compared to the prior year Liquidity as of June 30, 2025 (in millions) | Component | Amount (in millions) | | :-------------------------------- | :------------------- | | Cash, cash equivalents & marketable securities | $69.3 | | Availability under revolving loan facility | $21.4 | | **Total Liquidity** | **$90.7** | - Cash usage decreased by **55% in Q2 2025** and **78% year-to-date** compared to the prior year, supporting an expected **50% reduction** in cash used for full-year 2025[7](index=7&type=chunk) [Cash Flow Activities](index=7&type=section&id=Cash%20Flow%20Activities) For the six months ended June 30, 2025, Treace reported positive net cash from operating activities, a significant improvement from a net cash outflow in the prior year, with investing activities resulting in a net cash outflow and financing activities providing a net cash inflow Six Months Ended June 30, 2025 Cash Flow Summary (in thousands) | Cash Flow Activity | 2025 | 2024 | | :-------------------------------- | :----- | :----- | | Net cash provided by (used in) operating activities | $1,148 | $(21,118) | | Net cash provided by (used in) investing activities | $(5,151) | $26,191 | | Net cash provided by (used in) financing activities | $705 | $126 | | Net increase (decrease) in cash and cash equivalents | $(3,298) | $5,199 | | Cash and cash equivalents at end of period | $8,052 | $18,181 | [Non-GAAP Financial Measures (Adjusted EBITDA)](index=2&type=section&id=Non-GAAP%20Financial%20Measures%20%28Adjusted%20EBITDA%29) Treace utilizes Adjusted EBITDA as a non-GAAP financial measure to evaluate operating performance, excluding items such as depreciation, interest, taxes, share-based compensation, and specific non-recurring costs, reporting a significant reduction in Adjusted EBITDA loss for both the second quarter and year-to-date periods in 2025 - Adjusted EBITDA is defined as net loss before depreciation and amortization, interest income/expense, taxes, share-based compensation, acquisition-related costs, restructuring costs, customer credit loss, litigation costs, and debt extinguishment loss[10](index=10&type=chunk) - Adjusted EBITDA loss improved by **58% in Q2 2025** compared to Q2 2024[6](index=6&type=chunk) Adjusted EBITDA Reconciliation (in thousands) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :-------------------------- | :------ | :------ | :------- | :------- | | Net loss | $(17,398)| $(21,206)| $(33,320)| $(39,882)| | EBITDA | $(14,276)| $(19,154)| $(27,267)| $(36,139)| | Share-based compensation expense | $9,577 | $6,740 | $18,270 | $14,148 | | Acquisition-related costs | — | $556 | — | $1,873 | | Restructuring costs | — | $964 | — | $964 | | Customer credit loss | — | $2,147 | — | $2,147 | | Litigation costs | $1,055 | — | $1,510 | — | | **Adjusted EBITDA** | **$(3,644)**| **$(8,747)**| **$(7,487)**| **$(17,007)**| Financial Outlook Treace Medical Concepts reaffirmed its full-year 2025 revenue guidance, projecting continued growth, and maintained its expectation for breakeven Adjusted EBITDA for the full year [Full-Year 2025 Guidance](index=2&type=section&id=Full-Year%202025%20Guidance) Treace Medical Concepts reaffirmed its full-year 2025 revenue guidance, projecting continued growth, and maintained its expectation for breakeven Adjusted EBITDA for the full year Full-Year 2025 Financial Guidance (in millions) | Metric | Guidance | | :---------------- | :------------------- | | Revenue | $224M to $230M | | Revenue Growth | 7% to 10% (YoY) | | Adjusted EBITDA | Breakeven | Company Information & Disclosures This section provides an overview of Treace Medical Concepts' focus on bunion and midfoot deformity solutions, along with investor relations details and forward-looking statement disclosures [About Treace Medical Concepts](index=3&type=section&id=About%20Treace%20Medical%20Concepts) Treace Medical Concepts is a medical technology company focused on advancing the surgical treatment of bunions and related midfoot deformities, known for its Lapiplasty® 3D Bunion Correction® System and expanded portfolio including Adductoplasty®, Nanoplasty®, Percuplasty™, and SpeedMTP® systems, along with digital solutions like IntelliGuide™ - Treace Medical Concepts is a medical technology company focused on surgical management of bunion and related midfoot deformities[15](index=15&type=chunk) - Pioneered the Lapiplasty® 3D Bunion Correction® System, designed to correct all three planes of bunion deformity and secure the unstable joint[15](index=15&type=chunk) - Expanded product portfolio includes Adductoplasty® Midfoot Correction System, Nanoplasty® 3D Minimally Invasive Bunion Correction System, Percuplasty™ Percutaneous 3D Bunion Correction System, and SpeedMTP® MTP Fusion System[15](index=15&type=chunk)[16](index=16&type=chunk) - Offers advanced digital solutions with its IntelliGuide™ patient-specific, pre-op planning and cut guide technology[16](index=16&type=chunk) [Investor Information and Forward-Looking Statements](index=2&type=section&id=Investor%20Information%20and%20Forward-Looking%20Statements) The company provides details for its upcoming conference call and investor day, and includes standard disclosures regarding the use of non-GAAP financial measures and forward-looking statements, advising investors on the inherent risks and uncertainties - Treace will host a conference call on **August 7, 2025, at 4:30 p.m. ET** to discuss Q2 2025 financial results[8](index=8&type=chunk) - An investor day is scheduled for **September 3, 2025**, in New York, NY, to highlight new products and feature presentations by management and surgeon users[9](index=9&type=chunk) - The press release contains forward-looking statements regarding 2025 guidance, liquidity, product adoptions, market position, and future product launches, which are subject to risks and uncertainties detailed in SEC filings[13](index=13&type=chunk) - Information important to investors is routinely posted in the 'Investor Relations' section of www.treace.com[14](index=14&type=chunk) Unaudited Financial Statements This section presents the unaudited consolidated financial statements, including statements of operations, balance sheets, cash flows, and reconciliation of GAAP net loss to Adjusted EBITDA for the specified periods [Statements of Operations and Comprehensive Loss](index=5&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section presents the unaudited consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024, detailing revenue, cost of goods sold, gross profit, operating expenses, and net loss Statements of Operations and Comprehensive Loss (in thousands, except per share) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $47,387 | $44,455 | $99,957 | $95,563 | | Gross profit | $37,752 | $35,674 | $79,645 | $76,655 | | Total operating expenses | $54,726 | $57,056 | $112,201 | $117,005 | | Loss from operations | $(16,974) | $(21,382) | $(32,556) | $(40,350) | | Net loss | $(17,398) | $(21,206) | $(33,320) | $(39,882) | | Net loss per share, basic and diluted | $(0.28) | $(0.34) | $(0.53) | $(0.64) | [Balance Sheets](index=6&type=section&id=Balance%20Sheets) This section provides the unaudited consolidated balance sheets as of June 30, 2025, and December 31, 2024, outlining assets, liabilities, and stockholders' equity Balance Sheets (in thousands) | Asset/Liability/Equity | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $8,052 | $11,350 | | Marketable securities, short-term | $61,237 | $64,327 | | Accounts receivable, net | $30,333 | $40,803 | | Inventories | $42,397 | $39,255 | | Total current assets | $147,602 | $161,402 | | Total assets | $206,443 | $217,094 | | **Liabilities** | | | | Accounts payable | $19,959 | $10,522 | | Total current liabilities | $41,900 | $34,925 | | Long-term debt, net | $53,454 | $53,306 | | Total liabilities | $108,828 | $104,202 | | **Stockholders' Equity** | | | | Total stockholders' equity | $97,615 | $112,892 | | Total liabilities and stockholders' equity | $206,443 | $217,094 | [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) This section details the unaudited consolidated statements of cash flows for the six months ended June 30, 2025, and 2024, categorizing cash flows from operating, investing, and financing activities Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Net cash provided by (used in) operating activities | $1,148 | $(21,118) | | Net cash provided by (used in) investing activities | $(5,151) | $26,191 | | Net cash provided by (used in) financing activities | $705 | $126 | | Net increase (decrease) in cash and cash equivalents | $(3,298) | $5,199 | | Cash and cash equivalents at end of period | $8,052 | $18,181 | [Reconciliation of GAAP Net Loss to EBITDA & Adjusted EBITDA](index=8&type=section&id=Reconciliation%20of%20GAAP%20Net%20Loss%20to%20EBITDA%20%26%20Adjusted%20EBITDA) This section provides a detailed reconciliation of GAAP net loss to EBITDA and Adjusted EBITDA for the three and six months ended June 30, 2025, and 2024, highlighting the adjustments made for non-GAAP reporting Reconciliation of GAAP Net Loss to EBITDA & Adjusted EBITDA (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(17,398) | $(21,206) | $(33,320) | $(39,882) | | EBITDA | $(14,276) | $(19,154) | $(27,267) | $(36,139) | | Share-based compensation expense | $9,577 | $6,740 | $18,270 | $14,148 | | Acquisition-related costs | — | $556 | — | $1,873 | | Restructuring costs | — | $964 | — | $964 | | Customer credit loss | — | $2,147 | — | $2,147 | | Litigation costs | $1,055 | — | $1,510 | — | | Adjusted EBITDA | $(3,644) | $(8,747) | $(7,487) | $(17,007) |

Core Insights - Treace Medical Concepts, Inc. has announced the full market release of three new bunion technologies, aiming to enhance surgical treatment options for bunions and related midfoot deformities [1][3] - The company reported a revenue increase of 7% in Q2 2025 compared to the same period in 2024, indicating strong demand for its expanded portfolio of 3D bunion solutions [4][8] Financial Performance - Revenue for Q2 2025 was $47.4 million, up from $44.5 million in Q2 2024, reflecting a 7% growth [4] - Gross profit for Q2 2025 was $37.8 million, with a gross margin of 79.7%, slightly down from 80.2% in Q2 2024 [4] - Total operating expenses decreased by 4.1% to $54.7 million in Q2 2025 from $57.1 million in Q2 2024 [5] - The net loss for Q2 2025 was $(17.4) million, or $(0.28) per share, an improvement from $(21.2) million, or $(0.34) per share, in Q2 2024 [6] - Adjusted EBITDA loss improved by 58% to $(3.6) million in Q2 2025 compared to $(8.7) million in Q2 2024 [6][8] Liquidity and Outlook - As of June 30, 2025, the company had total liquidity of $90.7 million, consisting of $69.3 million in cash and marketable securities and $21.4 million available under a revolving loan facility [7] - The company reaffirmed its full-year 2025 revenue guidance of $224 million to $230 million, representing a growth of 7% to 10% compared to 2024 [8] Product Development and Market Position - The company has expanded its bunion technology portfolio with the full market release of the Nanoplasty and Percuplasty™ systems, as well as the SpeedMTP MTP Fusion System [8] - Treace's patent portfolio has grown to 117 granted patents and 163 pending applications, enhancing its competitive position in the market [8] Strategic Initiatives - The CEO expressed confidence that the new technologies, along with existing systems like Lapiplasty and Adductoplasty, will establish Treace as a leading provider of surgical bunion technology [3]