• Treace Medical Concepts Reports First Quarter 2025 Financial Results

    来源: Nasdaq GlobeNewswire / 08 5月 2025 16:05:01   America/New_York

    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 period in 2024.
    • Improved first quarter 2025 net loss by 15% to $(15.9) million compared to $(18.7) million in the same period in 2024. Improved adjusted EBITDA by 53% to $(3.8) million in the first quarter 2025 compared to $(8.3) million in the same period in 2024.
    • Expanded bunion technology portfolio through limited market releases of the Nanoplasty™ and the Percuplasty™ 3D MIS Osteotomy Systems, and the SpeedMTP™ MTP Fusion System, with additional launches expected in 2025.
    • Announced positive interim clinical data for Lapiplasty, Mini Lapiplasty, and Adductoplasty procedures, at the 2025 ACFAS Annual Scientific Conference.
    • Broadened global patent portfolio surpassing 100 granted patents in addition to 172 pending patent applications.

    “We are pleased with the positive customer responses to our three new specialized bunion systems targeting all four classes of bunion deformities while we continue to expand our differentiated body of clinical evidence and drive adoption of our flagship Lapiplasty and Adductoplasty procedures. Our first quarter results represent solid growth versus a difficult comp and strong improvements in adjusted EBITDA,” said John T. Treace, CEO, Founder and Board Member of Treace. “Looking ahead, our expanding best in class bunion portfolio and robust innovation pipeline along with significant surgeon training momentum positions Treace for accelerating growth throughout the year and to extend our leadership position within the US bunion market.”

    First Quarter 2025 Financial Results

    Revenue for the first quarter of 2025 was $52.6 million, representing an increase of 3% compared to $51.1 million in the first quarter of 2024. Adjusted for one less selling day in 2025, the first quarter of 2025 increased 4.5% compared to the prior year.

    Gross profit for the first quarter of 2025 was $41.9 million compared to $41.0 million in the first quarter of 2024. Gross margin was 79.7% in the first quarter of 2025, compared to 80.2% in the first quarter of 2024.

    Total operating expenses were $57.5 million in the first quarter of 2025, compared to total operating expenses of $59.9 million in the first quarter of 2024.

    First quarter 2025 net loss was $(15.9) million, or $(0.25) per share, compared to $(18.7) million, or $(0.30) per share, for the same period in 2024. Adjusted EBITDA was $(3.8) million in the first quarter of 2025 compared to $(8.3) million for the same period in 2024. See below for additional information and a reconciliation of non-GAAP financial information.

    Treace had $98.6 million of total liquidity as of March 31, 2025, comprised of $76.1 million of cash, cash equivalents and marketable securities and $22.5 million of availability under the revolving loan facility.

    2025 Financial Outlook

    The Company is reaffirming full-year 2025 revenue guidance of $224 million to $230 million, representing growth of 7% to 10%, compared to full-year 2024.

    The Company continues to expect breakeven Adjusted EBITDA for the full-year 2025.*

    Webcast and Conference Call Details

    Treace will host a conference call today, May 8, 2025, at 4:30 p.m. ET to discuss its first quarter 2025 financial results. Investors interested in listening to the conference call may do so by registering. Once registered, participants will receive dial-in numbers and a unique pin to join the call and ask questions. The live webcast of the conference call will be available on the Investor Relations section of the Company’s website at investors.treace.com. The webcast will be archived on the website following the completion of the call.

    Use of Non-GAAP Financial Measures

    To supplement the financial results presented in accordance with GAAP, this earnings release presents Adjusted EBITDA, which the Company defines as net loss before depreciation and amortization expense, interest income, interest expense, taxes, share-based compensation expense, acquisition-related costs, restructuring costs, customer credit loss, litigation costs, and debt extinguishment loss. Non-GAAP financial measures such as Adjusted EBITDA are presented in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Management uses non-GAAP financial measures to evaluate the Company’s operating performance and trends, as well as for making planning decisions. The Company believes that Adjusted EBITDA helps to identify underlying trends in the Company’s business that may otherwise be masked by the effect of the income and expenses and other items that it excludes in its calculation of Adjusted EBITDA. Accordingly, the Company believes this non-GAAP financial measure provides useful information to investors and others in understanding and evaluating the Company’s operating results, enhancing the overall understanding of its past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by the Company’s management in their financial and operational decision-making. The Company also presents this non-GAAP financial measure because it believes investors, analysts and rating agencies consider it to be a useful metric in measuring the Company’s performance against other companies and its ability to meet its debt service obligations.

    There are limitations related to the use of non-GAAP financial measures such as Adjusted EBITDA because they are not prepared in accordance with GAAP, may exclude significant income and expenses required by GAAP to be recognized in the Company’s financial statements, and may not be comparable to non-GAAP financial measures used by other companies. The Company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. A reconciliation between GAAP and non-GAAP results is presented below.

    *A reconciliation of Adjusted EBITDA to GAAP net loss on a forward-looking basis is not available without unreasonable efforts due to the high variability, complexity and low visibility with respect to the items excluded from this non-GAAP measure.

    Forward-Looking Statements

    This press release and statements made during the Company’s earnings call contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements, including, but not limited to, the Company’s: 2025 full-year guidance; anticipated liquidity; 2025 Adjusted EBITDA breakeven guidance; expected 2025 cash burn decrease; anticipated expansion of clinical evidence; expected increase in product adoptions; continued execution of strategic initiatives; belief that it is positioned for accelerating growth throughout the year and to extend its leadership position within the US bunion market; ability to effectively respond to and mitigate the impact of challenges in the current market environment, including in response to new or increased tariffs, changes in trade policies, economic uncertainty, or increased competition and accelerating adoption of MIS osteotomy solutions; anticipated future product launches and the timing of such product launches, including the timing for full commercial availability of the Nanoplasty™ and Percuplasty™ Systems and the number and pace of new product innovations through 2025; ability to increase its procedure volumes, expand its surgeon customer base, provide a suite of technologies to address the evolving needs of bunion surgeons, and increase penetration into the bunion market; strategic investments supporting its market position and long-term outlook; ability to protect and enforce its intellectual property rights, including through its recently filed patent infringement and unfair competition suit; success in defending against securities class actions and infringement of its intellectual property by third parties, including its competitors; expected seasonality; and anticipated pace of growth in the foot and ankle market. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results or other events to differ materially from those contemplated in this press release can be found in the Risk Factors section of Treace’s public filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 27, 2025. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of their date and, except to the extent required by law, the Company undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. The Company’s results for the quarter ended March 31, 2025 are not necessarily indicative of its operating results for any future periods.

    Internet Posting of Information

    Treace routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.treace.com. The Company encourages investors and potential investors to consult the Treace website regularly for important information about Treace.

    About Treace Medical Concepts

    Treace Medical Concepts, Inc. is a medical technology company with the goal of advancing the standard of care for the surgical management of bunion and related midfoot deformities. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 67 million Americans, of which Treace estimates 1.1 million are annual surgical candidates. Treace has pioneered and patented the Lapiplasty® 3D Bunion Correction® System – a combination of instruments, implants, and surgical methods designed to surgically correct all three planes of the bunion deformity and secure the unstable joint, addressing the root cause of the bunion and helping patients get back to their active lifestyles. To further support the needs of bunion patients, Treace has introduced its Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of midfoot deformities, the SpeedMTP™ Rapid Compression Implant for addressing bunions through big toe joint fusions, and two systems for minimally invasive osteotomy surgeries: the Nanoplasty™ 3D Minimally Invasive Bunion Correction System and the Percuplasty™ Percutaneous 3D Bunion Correction System. The Company continues to expand its footprint in the foot and ankle market with the introduction of its SpeedPlate™ Rapid Compression Implants, an innovative fixation platform with broad versatility across Lapiplasty® and Adductoplasty® procedures, as well as other common bone fusion procedures of the foot. For more information, please visit www.treace.com.

    To learn more about Treace, connect with us on LinkedInXFacebook and Instagram.

    Contacts:

    Treace Medical Concepts
    Mark L. Hair
    Chief Financial Officer
    mhair@treace.net 
    (904) 373-5940

    Investors:
    Gilmartin Group
    Philip Trip Taylor
    IR@treace.net 


     
    Treace Medical Concepts, Inc.
    Statements of Operations and Comprehensive Loss
    (in thousands, except share and per share amounts)
    (unaudited)
     
      Three Months Ended
    March 31,
     
      2025  2024 
    Revenue $52,570  $51,108 
    Cost of goods sold  10,677   10,127 
    Gross profit  41,893   40,981 
    Operating expenses      
    Sales and marketing  36,122   40,328 
    Research and development  5,562   5,259 
    General and administrative  15,791   14,362 
    Total operating expenses  57,475   59,949 
    Loss from operations  (15,582)  (18,968)
    Interest income  841   1,535 
    Interest expense  (1,311)  (1,317)
    Other income, net  130   74 
    Other non-operating income (expense), net  (340)  292 
    Net loss $(15,922) $(18,676)
           
    Other comprehensive income (loss)      
    Unrealized gain (loss) on marketable securities $(40) $(94)
    Comprehensive loss $(15,962) $(18,770)
           
    Net loss per share, basic and diluted $(0.25) $(0.30)
    Weighted-average shares used in computing net loss per share, basic and diluted  62,661,447   61,792,788 


     
     
    Treace Medical Concepts, Inc.
    Balance Sheets
    (in thousands, except share and per share amounts)
    (unaudited)
     
      March 31,  December 31, 
      2025  2024 
    Assets      
    Current assets      
    Cash and cash equivalents $13,372  $11,350 
    Marketable securities, short-term  62,717   64,327 
    Accounts receivable, net of allowance for credit losses of $1,441 and $1,326 as of March 31, 2025 and December 31, 2024, respectively  31,110   40,803 
    Inventories  37,940   39,255 
    Prepaid expenses and other current assets  4,298   5,667 
    Total current assets  149,437   161,402 
    Property and equipment, net  27,129   25,953 
    Intangible assets, net of accumulated amortization of $1,663 and $1,425 as of March 31, 2025 and December 31, 2024, respectively  7,837   8,075 
    Goodwill  12,815   12,815 
    Operating lease right-of-use assets  8,241   8,442 
    Other non-current assets  387   407 
    Total assets $205,846  $217,094 
    Liabilities and Stockholders’ Equity      
    Current liabilities      
    Accounts payable $13,223  $10,522 
    Accrued liabilities  6,008   7,197 
    Accrued commissions  6,529   10,121 
    Accrued compensation  5,190   6,575 
    Other liabilities  2,230   510 
    Total current liabilities  33,180   34,925 
    Long-term debt, net  53,380   53,306 
    Operating lease liabilities, net of current portion  13,908   15,934 
    Other long-term liabilities  37   37 
    Total liabilities  100,505   104,202 
    Commitments and contingencies (Note 7)      
    Stockholders’ equity      
    Preferred stock, $0.001 par value, 5,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 0 shares issued as of March 31, 2025 and December 31, 2024      
    Common stock, $0.001 par value, 300,000,000 shares authorized; 62,967,502 and 62,385,101 shares issued as of March 31, 2025 and December 31, 2024, respectively  63  62 
    Additional paid-in capital  311,815   303,004 
    Accumulated deficit  (205,912)  (189,990)
    Accumulated other comprehensive (loss) income  57   97 
    Treasury stock, at cost; 75,996 and 23,391 shares as of March 31, 2025 and December 31, 2024, respectively  (682)  (281)
    Total stockholders’ equity  105,341   112,892 
    Total liabilities and stockholders’ equity $205,846  $217,094 


     
    Treace Medical Concepts, Inc.
    Statements of Cash Flows
    (in thousands)
    (unaudited)
     
      Three Months Ended March 31, 
      2025  2024 
    Cash flows from operating activities      
    Net loss $(15,922) $(18,676)
    Adjustments to reconcile net loss to net cash provided by (used in) operating activities      
    Depreciation and amortization expense  2,461   1,909 
    Provision for allowance for credit losses  500   159 
    Share-based compensation expense  8,693   7,408 
    Non-cash lease expense  578   592 
    Amortization of debt issuance costs  74   75 
    Amortization (accretion) of premium (discount) on marketable securities, net  (77)  (335)
    Other, net  187   90 
    Net changes in operating assets and liabilities, net of acquisitions      
    Accounts receivable  9,289   7,821 
    Inventory  1,315   (6,615)
    Prepaid expenses and other assets  1,369   (1,495)
    Other non-current assets  (76)   
    Operating lease liabilities  (785)  (657)
    Accounts payable  2,701   9,314 
    Accrued liabilities  (6,166)  (6,918)
    Other, net  57   107 
    Net cash provided by (used in) operating activities  4,198   (7,221)
           
    Cash flows from investing activities      
    Purchases of available-for-sale marketable securities  (15,090)  (28,711)
    Sales and maturities of available-for-sale marketable securities  16,739   36,396 
    Purchases of property and equipment  (3,543)  (3,927)
    Net cash provided by (used in) investing activities  (1,894)  3,758 
           
    Cash flows from financing activities      
    Proceeds from exercise of employee stock options  119   52 
    Taxes from withheld shares  (401)  (237)
    Net cash provided by (used in) financing activities  (282)  (185)
    Net increase (decrease) in cash and cash equivalents  2,022   (3,648)
    Cash and cash equivalents at beginning of period  11,350   12,982 
    Cash and cash equivalents at end of period $13,372  $9,334 
           
    Supplemental disclosure of cash flow information      
    Cash paid for interest $1,229  $1,317 
    Noncash investing activities      
    Unrealized (gains) losses, net on marketable securities $40  $94 
    Unsettled matured marketable security and receivable from broker $  $2,100 
    Noncash financing activities      
    Legal cost financing $45  $ 


     
    Treace Medical Concepts, Inc.
    Reconciliation of GAAP Net Loss to EBITDA & Adjusted EBITDA
    (in thousands)
    (unaudited)
     
     Three Months Ended
    March 31,
     
     2025  2024 
    Net loss$(15,922) $(18,676)
    Adjustments:     
    Interest income (841)  (1,535)
    Interest expense 1,311   1,317 
    Taxes     
    Depreciation & Amortization 2,461   1,909 
    EBITDA$(12,991) $(16,985)
    Share-based compensation expense 8,693   7,408 
    Acquisition-related costs    1,317 
    Litigation costs1 455    
    Adjusted EBITDA$(3,843) $(8,260)

    1 Litigation costs related to the lawsuit the Company filed against Stryker Corporate and its subsidiary Wright Medical Technology, Inc. on October 14, 2024.


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