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Rising HIFU sales but deeper 2025 loss at EDAP TMS (NASDAQ: EDAP)

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

EDAP TMS reported mixed fourth quarter and full-year 2025 results, highlighting rapid HIFU growth but wider losses. In Q4 2025, HIFU revenue rose to €11.7 million, up 34% year-over-year, with fourteen Focal One systems sold and 28% growth in U.S. procedures.

Non-core ESWL and distribution revenue fell to €7.2 million, pulling total Q4 revenue down 7% to €18.9 million. Q4 net loss widened to €8.2 million, or €0.22 per share, compared with €1.9 million, or €0.05 per share, a year earlier.

For full-year 2025, HIFU revenue grew 39% to a record €33.1 million, while company-wide revenue slipped 3% to €62.4 million. Net loss increased to €25.9 million, or €0.69 per share, and cash and cash equivalents declined to €17.4 million as of December 31, 2025.

The company reiterated 2026 revenue guidance of $72.0 million to $80.0 million, with core HIFU revenue expected between $50.0 million and $54.0 million, representing 34% to 45% year-over-year growth in its core HIFU business.

Positive

  • Core HIFU business scaling rapidly. HIFU revenue grew 39% in 2025 to €33.1 million, with division gross margin of 48.1% and continued growth in Focal One system placements and procedures, supporting reiterated 2026 HIFU revenue guidance of $50.0–$54.0 million (34–45% growth).

Negative

  • Widening losses and lower total revenue. Company-wide 2025 revenue declined 3% to €62.4 million while net loss increased to €25.9 million (from €19.0 million), cash and short-term investments dropped to €17.4 million, and operating cash flow was negative €14.5 million.

Insights

HIFU growth is strong, but overall revenue softness and rising losses temper the story.

EDAP TMS is clearly gaining traction in its core HIFU franchise. HIFU revenue grew 39% in 2025 to €33.1 million, with 2025 division gross margin at 48.1% and increasing Focal One system placements and procedures, particularly in the U.S.

However, non-core ESWL and distribution revenue declined 27% to €29.4 million, pulling total company revenue down 3% to €62.4 million. Full-year net loss widened to €25.9 million and operating cash flow was negative €14.5 million, while cash and short-term investments fell to €17.4 million.

Management reiterated 2026 revenue guidance of $72.0–$80.0 million, with core HIFU expected to reach $50.0–$54.0 million, implying 34–45% HIFU growth. Future filings will clarify how quickly HIFU scale and improving mix can offset ongoing operating losses and cash burn.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 25, 2026

 

 

 

EDAP TMS SA

(Exact name of registrant as specified in its charter)

 

 

 

France 000-29374 98-1644844
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.)

 

Parc d'Activites la Poudrette-Lamartine

4/6, rue du Dauphiné

Vaulx-en-Velin, France 69120

(Address of Principal Executive Offices) (Zip Code)

 

(+33) 47-215-3150

(Registrant's telephone number, including area code)

 

 

(Former name or former address, if changed since last report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
American Depositary Shares, each representing one Ordinary Share (Ordinary Shares, nominal value €0.13 per share) EDAP NASDAQ Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On March 25, 2026, EDAP TMS S.A. issued a press release and will hold a conference call regarding its financial results for the quarter ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this report.

 

The information furnished with this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1   Press Release dated March 25, 2026
104   Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document

 

 

 

 

 

 

 

 

 

 

 

 

 

Signature

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  EDAP TMS S.A
     
     
Date: March 25, 2026 By: /s/ Sanket Shah
    Sanket Shah
    General Counsel and Corporate Secretary
     

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 99.1

 

EDAP Reports Record Fourth Quarter and Full-Year 2025 HIFU Revenue

 

 

39% Full-Year YoY HIFU Revenue Growth, Record Performance Driven by Increased Focal One® System Sales and Growth in the Number of U.S. Focal One Procedures
   
69% Full-Year YoY Growth in Focal One System Placements
   
28% Q4 YoY Growth in U.S. Procedures, Marking the Second Consecutive Quarter of Double-Digit Procedure Growth
   
Demand for Focal One Systems Remains Strong with System Placements in Academic Cancer Centers, Community Hospitals, and Large Integrated Healthcare Networks
   
Company Reiterates its Previously Issued 2026 Revenue Guidance; HIFU Revenue Expected to Grow Between 34% and 45% YoY

 

AUSTIN, Texas, March 25, 2026 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today financial results for the fourth quarter and full-year 2025.

 

“We experienced strong global demand for Focal One Robotic HIFU as demonstrated by our 2025 results," said Ryan Rhodes, Chief Executive Officer. "In the fourth quarter, we achieved a quarterly record of net system placements of 15, of which 14 were cash sales and one was an operating lease. We also experienced robust Focal One procedure growth in the U.S., which reflects a growing number of urologists utilizing focal therapy to manage early-stage prostate cancer. We believe demand for Focal One is being driven by growing clinical data, the versatility and adaptability of the Focal One platform, and increasing patient demand for a non-invasive treatment option designed to help preserve urinary and sexual function.”

 

Mr. Rhodes added, “Entering 2026, our pipeline continues to build, and demand for Focal One remains well balanced across both academic and community treatment centers. Importantly, we are also beginning to see large, integrated healthcare networks purchase multiple Focal One systems, signifying that Focal One is increasingly being adopted as an important technology platform for addressing early-stage prostate cancer. Looking ahead, we believe the adoption of focal therapy will continue to expand globally, and we remain well positioned to meet this growing demand from urologists and their patients.”

 

2026 Financial Guidance

 

The Company reiterates its previously issued 2026 revenue guidance of $72.0 million to $80.0 million. The Company’s core HIFU business revenue is expected to be in the range of $50.0 million to $54.0 million, which represents 34% to 45% year-over-year growth in the Company’s core HIFU business revenue.

 

Fourth Quarter 2025 Results

 

High-Intensity Focused Ultrasound (HIFU) Business

 

Total revenue in the HIFU business for the fourth quarter of 2025 was €11.7 million ($13.5 million), compared to €8.8 million ($9.4 million) for the same period in 2024, representing an increase of 34% year-over-year. The Company sold fourteen Focal One systems during the quarter, compared to eleven system sales in the same period in 2024. Worldwide disposables revenue grew 43% year-over-year, driven primarily by 28% growth in Focal One procedures in the U.S.

 

 

 

 

Non-Core Businesses (ESWL and Distribution)

 

Total revenue from the Company’s non-core businesses (ESWL and Distribution) for the fourth quarter of 2025 was €7.2 million ($8.4 million), compared to €11.5 million ($12.3 million) for the same period in 2024. The decline primarily reflects lower revenue in the Company’s non-core businesses as the Company continues to prioritize growth in its HIFU business.

 

Company

 

Total worldwide revenue for the fourth quarter of 2025 was €18.9 million ($21.9 million), compared to €20.3 million ($21.8 million) for the same period in 2024, representing a 7% decrease year-over-year.

 

Gross margin for the fourth quarter of 2025 was €8.1 million ($9.3 million), compared to €9.1 million ($9.8 million) for the same period in 2024. Gross margin on net sales was 42.6%, down from 44.8% for the same period in 2024. The decline in gross margin was primarily due to the impact of tariffs on imports of finished goods from France and an inventory reserve related to legacy parts. Excluding these items, gross margin would have been approximately 46.9%.

 

Operating expenses for the fourth quarter of 2025 were €13.2 million ($15.3 million), compared to €12.8 million ($13.7 million) for the same period in 2024.

 

Operating loss for the fourth quarter of 2025 was €5.2 million ($6.0 million), compared to €3.7 million ($4.0 million) for the same period in 2024.

 

Net loss for the fourth quarter of 2025 was €8.2 million ($9.5 million), or (€0.22) per share, compared to €1.9 million ($2.0 million), or (€0.05) per share, for the same period in 2024.

 

Full-Year 2025 Results

 

High-Intensity Focused Ultrasound (HIFU) Business

 

Total revenue in the HIFU business for the twelve months ended December 31, 2025, was €33.1 million ($37.4 million), an increase of 39% as compared to €23.8 million ($25.8 million) for the twelve months ended December 31, 2024.

 

Non-Core Businesses (ESWL and Distribution)

 

Total revenue in the Company’s non-core businesses (ESWL and Distribution) for the twelve months ended December 31, 2025, was €29.4 million ($33.2 million), a 27% decrease compared to €40.3 million ($43.6 million) for the twelve months ended December 31, 2024.

 

Company

 

Total worldwide revenue for the twelve months ended December 31, 2025, was €62.4 million ($70.5 million), a decrease of 3% compared to €64.1 million ($69.4 million) for the same period in 2024.

 

Gross profit for the twelve months ended December 31, 2025, was €26.6 million ($30.0 million), compared to €26.6 million ($28.7 million), for the twelve months ended December 31, 2024. Gross profit margin on net sales was 42.5% for the twelve months ended December 31, 2025, compared to 41.4% for the comparable period in 2024.

 

Operating expenses were €48.4 million ($54.7 million) for the twelve months ended December 31, 2025, compared to €47.1 million ($51.0 million) for the same period in 2024.

 

Operating loss for the twelve months ended December 31, 2025, was €21.9 million ($24.7 million), compared to an operating loss of €20.5 million ($22.2 million) for the twelve months ended December 31, 2024.

 

Net loss for the twelve months ended December 31, 2025, was €25.9 million ($29.2 million), or €(0.69) per share, as compared to a net loss of €19.0 million ($20.6 million), or €(0.51) per share for the twelve months ended December 31, 2024.

 

 

 

 

As of December 31, 2025, the Company held cash and cash equivalents of €17.4 million ($20.5 million) as compared to €29.8 million ($31.0 million) as of December 31, 2024.

 

Upcoming Meetings and Events

 

·American Urological Association (AUA) Annual Meeting, which will take place from May 15-18, 2026, in Washington, D.C.

 

·Investor Day Meeting – June 1, 2026, Nasdaq MarketSite, in New York City

 

·Jefferies Global Healthcare Conference – June 2–4, 2026, in New York City

 

Conference Call Information

 

A conference call and webcast to discuss the fourth quarter and full-year 2025 financial results will be hosted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and François Dietsch, Chief Accounting Officer. Please refer to the information below for conference call dial-in information and webcast registration.

 

Date: Wednesday, March 25, 2026, at 8:30 a.m. Eastern Time
Domestic: 1-800-579-2543
International: 1-785-424-1789
Passcode (Conf ID): EDAP
   
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1751611&tp_key=27ba007fb5

 

Currency Translation

 

Euro-denominated amounts have been translated into U.S. dollars for convenience using an average exchange rate of $1.15 = €1.00 for the fourth quarter of 2025, $1.13 = €1.00 for the full year 2025, and $1.17 = €1.00 for 2026 financial guidance for illustrative purposes.

 

About EDAP TMS SA

 

A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes, and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics, and precise non-invasive energy delivery, EDAP introduced the Focal One® in Europe and the United States as a leading prostate focal therapy platform controlled by urologists, with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com.

 

Forward-Looking Statements

 

In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.

 

Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 10-K.

 

 

 

 

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.

 

Investor Contact

Louisa Smith

Gilmartin Group

investor.relations@focalone.com

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EDAP TMS S.A.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands of Euros and U.S. Dollars, except per share data)

 

   Three Months Ended:  Three Months Ended:
   December 31,  December 31,  December 31,  December 31,
   2025  2024  2025  2024
   Euros  Euros  U.S. Dollars  U.S. Dollars
Sales of medical equipment   13,659    14,559    15,764    15,619 
Net sales of RPP and leases   2,506    2,363    2,905    2,533 
Sales of spare parts, supplies and services   2,771    3,395    3,212    3,632 
TOTAL REVENUES   18,936    20,318    21,880    21,785 
Cost of sales   (10,874)   (11,220)   (12,564)   (12,020)
GROSS PROFIT   8,063    9,098    9,316    9,765 
Research & development expenses   (1,800)   (1,865)   (2,109)   (1,991)
Selling, general & administrative expenses   (11,426)   (10,971)   (13,227)   (11,741)
Total operating expenses   (13,226)   (12,836)   (15,336)   (13,732)
OPERATING LOSS   (5,164)   (3,738)   (6,020)   (3,967)
Financial (expense) income, net   (2,660)   122    (3,007)   130 
Currency exchange gains (loss), net   (316)   1,664    (363)   1,803 
LOSS BEFORE INCOME TAXES   (8,140)   (1,952)   (9,391)   (2,034)
Income tax (expense) credit, net   (55)   11    (65)   14 
NET LOSS   (8,194)   (1,940)   (9,456)   (2,020)
Earnings per share – Basic and diluted   (0.22)   (0.05)   (0.25)   (0.05)
Average number of shares used in computation of basic and diluted EPS   37,447,486    37,371,992    37,447,486    37,371,992 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EDAP TMS S.A.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands of Euros and U.S. Dollars, except per share data)

 

   Year Ended:  Year Ended:
   December 31,  December 31,  December 31,  December 31,
   2025  2024  2025  2024
   Euros  Euros  U.S. Dollars  U.S. Dollars
Sales of medical equipment   43,273    44,037    48,896    47,664 
Net sales of RPP and leases   9,106    7,610    10,289    8,237 
Sales of spare parts, supplies and services   10,037    12,468    11,342    13,495 
TOTAL REVENUES   62,416    64,114    70,527    69,395 
Cost of sales   (35,865)   (37,558)   (40,526)   (40,652)
GROSS PROFIT   26,551    26,556    30,001    28,744 
Research & development expenses   (8,550)   (7,726)   (9,661)   (8,363)
Selling, general & administrative expenses   (39,856)   (39,364)   (45,035)   (42,606)
Total operating expenses   (48,406)   (47,090)   (54,695)   (50,969)
OPERATING LOSS   (21,854)   (20,534)   (24,694)   (22,225)
Financial (expense) income, net   (2,753)   560    (3,110)   606 
Currency exchange gains (loss), net   (888)   1,245    (1,003)   1,348 
LOSS BEFORE INCOME TAXES   (25,495)   (18,729)   (28,808)   (20,271)
Income tax (expense) credit, net   (388)   (289)   (438)   (313)
NET LOSS   (25,883)   (19,018)   (29,246)   (20,584)
Earnings per share – Basic and diluted   (0.69)   (0.51)   (0.78)   (0.55)
Average number of shares used in computation of basic and diluted EPS   37,442,155    37,286,446    37,442,155    37,286,446 

 

EDAP TMS S.A.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(Amounts in thousands of Euros and U.S. Dollars)

 

             
   December 31,  December 31,  December 31,  December 31,
   2025  2024  2025  2024
   Euros  Euros  U.S. Dollars  U.S. Dollars
Cash, cash equivalents and short-term investments   17,407    29,836    20,452    30,995 
Accounts receivable, net   19,220    20,288    22,583    21,077 
Inventory   10,919    18,495    12,830    19,213 
Other current assets   1,105    1,258    1,299    1,307 
TOTAL CURRENT ASSETS   48,652    69,876    57,164    72,591 
Property, plant and equipment, net   11,494    10,336    13,505    10,738 
Goodwill   2,412    2,412    2,834    2,505 
Other non-current assets   4,677    3,439    5,495    3,573 
TOTAL ASSETS   67,235    86,063    78,997    89,407 
Accounts payable and other accrued liabilities   17,611    21,350    20,692    22,180 
Deferred revenues, current portion   6,041    6,641    7,098    6,899 
Short-term borrowing   5,095    6,243    5,986    6,485 
Other current liabilities   2,864    3,577    3,365    3,716 
TOTAL CURRENT LIABILITIES   31,610    37,811    37,141    39,280 
Obligations under operating and finance leases non-current   2,067    1,939    2,429    2,014 
Long-term debt, non-current   13,535    2,162    15,903    2,246 
Deferred revenues, non-current   822    358    966    372 
Other long-term liabilities   2,677    2,897    3,145    3,010 
TOTAL LIABILITIES   50,712    45,167    59,584    46,922 
TOTAL SHAREHOLDERS’ EQUITY   16,523    40,896    19,413    42,485 
TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY   67,235    86,063    78,997    89,407 

 

 

 

 

EDAP TMS S.A.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Amounts in thousands of Euros and U.S. Dollars)

 

             
   Year Ended  Twelve Months Ended  Year Ended  Twelve Months Ended
   December 31,  December 31,  December 31,  December 31,
   2025  2024  2025  2024
   (Euros)  (Euros)  (U.S. Dollars)  (U.S. Dollars)
NET INCOME (LOSS)   (25,883)   (19,018)   (29,246)   (20,584)
Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities (1)   8,769    7,395    9,908    8,004 
OPERATING CASH FLOW   (17,114)   (11,623)   (19,338)   (12,580)
Increase/Decrease in operating assets and liabilities   2,592    (1,961)   2,929    (2,123)
NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES   (14,522)   (13,584)   (16,409)   (14,703)
Additions to capitalized assets produced by the company and other capital expenditures   (5,058)   (4,120)   (5,715)   (4,459)
NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES   (5,058)   (4,120)   (5,715)   (4,459)
NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES   7,620    4,635    8,610    5,016 
NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS   (469)   (566)   2,972    (2,893)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS   (12,429)   (13,635)   (10,543)   (17,039)

 

(1) including share-based compensation expenses for 2,265 thousand of Euros for the year ended December 31, 2025 and 3,283 thousand of Euros for the year ended December 31, 2024.

 

 

 

 

 

 

 

EDAP TMS S.A.

UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION

Twelve months ended December 31, 2025

(Amounts in thousands of Euros)

 

                            
   HIFU     ESWL     Distribution     Reconciling  Total After   
   Division     Division     Division     Items  Consolidation   
Sales of medical equipment   21,998         1,515         19,760             43,273      
Net sales of RPP and leases   7,780         1,025         300             9,106      
Sales of spare parts, supplies and services   3,277         4,065         2,695             10,037      
TOTAL REVENUES   33,056         6,605         22,756             62,416      
GROSS PROFIT (% of Net Sales)   15,911    48.1%   3,050    46.2%   7,591    33.4%       26,551    42.5%
Research & development expenses   (7,884)        (169)        (496)            (8,550)     
Selling, general & administrative expenses   (26,327)        (1,023)        (7,810)        (4,695)   (39,856)     
OPERATING PROFIT (LOSS)   (18,301)        1,857         (716)        (4,695)   (21,854)     

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FAQ

How did EDAP (EDAP) perform in its core HIFU business in 2025?

EDAP’s core HIFU business grew strongly in 2025, with HIFU revenue rising 39% to €33.1 million. Growth was driven by higher Focal One system sales and increased procedure volumes, especially in the U.S., underscoring momentum in prostate focal therapy adoption.

What were EDAP (EDAP) total revenue and net loss for full-year 2025?

For 2025, EDAP generated total revenue of €62.4 million, down 3% from 2024. Net loss widened to €25.9 million, or €0.69 per share, compared with a €19.0 million net loss and €0.51 per share in the prior year, reflecting higher losses despite HIFU growth.

How did EDAP (EDAP) perform in the fourth quarter of 2025?

In Q4 2025, EDAP reported total revenue of €18.9 million, a 7% decrease year-over-year. HIFU revenue reached €11.7 million, up 34%, but non-core revenues fell. Net loss for the quarter was €8.2 million, or €0.22 per share, compared to €1.9 million previously.

What 2026 revenue guidance did EDAP (EDAP) provide?

EDAP reiterated 2026 total revenue guidance of $72.0 million to $80.0 million. The company expects core HIFU business revenue between $50.0 million and $54.0 million, representing 34% to 45% year-over-year growth, highlighting expectations of continued expansion in HIFU adoption.

What is the financial condition of EDAP (EDAP) regarding cash and debt?

As of December 31, 2025, EDAP held €17.4 million in cash, cash equivalents and short-term investments, down from €29.8 million a year earlier. Long-term debt (non-current) increased to €13.5 million from €2.2 million, while total shareholders’ equity fell to €16.5 million.

How did EDAP’s non-core ESWL and distribution businesses perform in 2025?

In 2025, EDAP’s non-core ESWL and distribution revenues declined 27% to €29.4 million from €40.3 million in 2024. Management indicated the decrease primarily reflects lower revenue in these businesses as the company continues prioritizing growth in its higher-potential HIFU segment.

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