SEC Form 6-K filed by EDAP TMS S.A.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
November 6, 2025
Commission File Number: 0-29374
EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ x] Form 40-F [ ]
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: November 6, 2025
EDAP TMS S.A.
/s/ KEN MOBECK
KEN MOBECK
CHIEF FINANCIAL OFFICER
EDAP Reports Third Quarter 2025 Financial Results
- 49% YoY HIFU Revenue Growth, Driven by Increased Focal One® Sales and U.S. Procedure Volumes
- 167% YoY Growth in Focal One System Placements
- 15% YoY Growth in U.S. Focal One HIFU Procedures
- Company to Host Conference Call and Webcast on November 6 at 8:30 a.m. ET
AUSTIN, Texas, November 6, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the third quarter of 2025.
“Our record-breaking third-quarter revenue performance reflects the continued strong demand for our leading Focal One Robotic HIFU platform, with system placements increasing 167% year over year. Even in a seasonally softer period, we achieved our second consecutive quarter of record HIFU revenue for the respective period, underscoring the consistent and positive growth of our business. It is becoming increasingly clear that more urologists want to offer their patients both an effective and non-invasive treatment option for early-stage prostate cancer. These factors are driving demand as seen over the last two quarters, which reflects this important growing paradigm shift in prostate cancer management. During the quarter we also saw a return to double-digit Focal One procedure growth in the U.S. as we continue to see broader hospital adoption, increased patient demand and expanded insurance provider coverage.” said Ryan Rhodes, Chief Executive Officer of EDAP.
“We have also made notable progress strengthening our balance sheet. As announced last month, we finalized an agreement with the European Investment Bank for a €36 million credit facility to be made available in three tranches, with €11 million from the first tranche deposited earlier this week. Looking ahead, our Focal One pipeline continues to expand, reflecting both growing demand and continued execution by our commercial and clinical teams.”
Business Update
| · | On October 20, 2025, the Company announced the closing of a €36 million credit facility with the European Investment Bank (EIB). Proceeds from this financing will support the continued expansion of the Company’s Focal One® Robotic HIFU platform in Focal Therapy, the fastest-growing treatment category for early-stage prostate cancer and accelerate the development of new clinical indications. |
| · | On September 30, 2025, the Company highlighted its Focal One Prostate Cancer Awareness Month campaign, featuring national television coverage on Friday, September 26, which reached millions of viewers nationwide. The segment, which included an interview with a patient treated with Focal One, aired during Health Uncensored with Dr. Drew on the Lifetime Network, providing unprecedented exposure and allowing audiences across the United States to learn about Focal One. In addition, the Company conducted multiple patient-education events and partnered with hospitals and practices nationwide to raise awareness through a range of local outreach activities. |
| · | On September 16, 2025, the Company announced that it was honored with the 2025 Industry Award for Innovations in Endourological Instrumentation by the Endourological Society, recognizing its groundbreaking work with the Focal One High-Intensity Focused Ultrasound (HIFU) platform. Focal One is the first Focal Therapy technology to receive this distinguished award. Presented annually to an individual or organization that has made outstanding contributions to the field of urology, the award was conferred during the 42nd World Congress of Endourology and Uro-Technology (WCET). |
Upcoming Meetings and Events
| · | UBS Global Healthcare Conference – November 10–13, 2025, in Palm Beach Gardens, Florida. | |
| EDAP management will participate in one-on-one meetings with investors. |
| · | Jefferies London Healthcare Conference – November 18–20, 2025, in London, U.K. | |
| EDAP management will present on Tuesday, November 18, from 4:30–4:55 p.m. GMT. |
| · | Piper Sandler 37th Annual Healthcare Conference – December 2–4, 2025, in New York, New York. | |
| EDAP management will present on Tuesday, December 2, at 10:30–10:55 a.m. ET. |
2025 Financial Guidance
The Company is reiterating its 2025 financial guidance. Core HIFU business revenue is expected to grow within the range of 26% to 34% year over year, and combined non-core ESWL and Distribution business revenue is expected to decline within the range of 25% to 30% year over year.
Third Quarter 2025 Results
High-Intensity Focused Ultrasound (HIFU) Business
Total revenue in the HIFU business for the third quarter of 2025 was €6.7 million (US $7.7 million), compared to €4.5 million (US $4.9 million) for the same period in 2024, representing an increase of 49% year over year. The Company sold six Focal One systems during the quarter, versus three system sales in the same period in 2024. Worldwide disposables revenue grew 9% year over year, driven primarily by 15% growth in Focal One procedures in the U.S.
Non-Core Businesses (ESWL and Distribution)
Total revenue from the Company’s non-core businesses for the third quarter of 2025 was €7.2 million (US $8.4 million), compared to €8.6 million (US $9.8 million) for the same period in 2024. The expected decline reflects the Company’s strategic decision to focus on the high-growth opportunity in Focal Therapy through its Focal One Robotic HIFU platform.
Company
Total worldwide revenue for the third quarter of 2025 was €13.9 million (US $16.1 million), an increase of 6% compared to €13.1 million (US $14.4 million) for the same period in 2024.
Gross profit for the third quarter of 2025 was €6.0 million (US $6.9 million), compared to €5.2 million (US $5.7 million) for the same period in 2024. Gross profit margin on net sales was 43%, up from 39% for the same period in 2024. The margin improvement was primarily due to a favorable product-mix shift and better absorption of fixed costs, largely attributable to the growth of HIFU revenue.
Operating expenses for the third quarter of 2025 were stable at €10.9 million (US $12.7 million), compared to €11.0 million (US $12.1 million) for the same period in 2024.
Operating loss for the third quarter of 2025 was €4.9 million (US $5.7 million), compared to €5.8 million (US $6.4 million) for the same period in 2024.
Net loss for the third quarter of 2025 was €5.0 million (US $5.8 million), or (€0.13) per share, compared to €6.4 million (US $7.0 million), or (€0.17) per share, for the same period in 2024
Year-to-Date Results
High-Intensity Focused Ultrasound (HIFU) Business
Total revenue in the HIFU business for the nine months ended September 30, 2025, was €21.3 million (US $23.9 million), an increase of 42% compared to €15.1 million (US $16.3 million) for the same period in 2024.
Non-Core Businesses (ESWL and Distribution)
Total revenue from the Company’s non-core businesses for the nine months ended September 30, 2025, was €22.2 million (US $24.9 million), a 23% decrease compared to €28.7 million (US $31.2 million) for the same period in 2024.
Company
Total worldwide revenue for the nine months ended September 30, 2025, was €43.5 million (US $48.8 million), a decrease of 0.7% compared to €43.8 million (US $47.6 million) for the same period in 2024.
Gross profit for the nine months ended September 30, 2025, was €18.5 million (US $20.7 million), compared to €17.5 million (US $19.0 million) for the same period in 2024. Gross profit margin on net sales improved to 42.5% for the nine-month period ended September 30, 2025, up from 39.9% for the same period in 2024.
Operating expenses for the nine months ended September 30, 2025, totaled €35.2 million (US $39.4 million), compared to €34.3 million (US $37.2 million) for the same period in 2024.
Operating loss for the nine months ended September 30, 2025, was €16.7 million (US $18.7 million), compared to €16.8 million (US $18.2 million) for the same period in 2024.
Net loss for the nine months ended September 30, 2025, was €17.7 million (US $19.8 million), or (€0.47) per share, compared to €17.1 million (US $18.5 million), or (€0.46) per share, for the same period in 2024.
As of September 30, 2025, the Company held cash and cash equivalents of €10.6 million (US $12.4 million), compared to €16.3 million (US $19.1 million) as of June 30, 2025.
Conference Call Information
A conference call and webcast to discuss the third quarter 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: | Thursday, November 6th @ 8:30am Eastern Time |
| Domestic: | 1-800-274-8461 |
| International: | 1-203-518-9814 |
| Passcode (Conf ID): | EDAP |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1738018&tp_key=c91765d4a0 |
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 in the U.S. as the leading prostate focal therapy 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 like the COVID 19 pandemic, 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 20-F.
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 Contacts
Investor Relations
EDAP TMS SA
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
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: | |||||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Euros | Euros | $US | $US | |||||||||||||
| Sales of medical equipment | 9,430 | 8,393 | 10,958 | 9,240 | ||||||||||||
| Net sales of RPP and leases | 2,194 | 1,586 | 2,550 | 1,746 | ||||||||||||
| Sales of spare parts, supplies and services | 2,255 | 3,120 | 2,621 | 3,435 | ||||||||||||
| TOTAL REVENUES | 13,879 | 13,098 | 16,128 | 14,420 | ||||||||||||
| Cost of sales | (7,908 | ) | (7,944 | ) | (9,189 | ) | (8,746 | ) | ||||||||
| GROSS PROFIT | 5,972 | 5,154 | 6,939 | 5,675 | ||||||||||||
| Research & development expenses | (2,086 | ) | (1,716 | ) | (2,424 | ) | (1,889 | ) | ||||||||
| Selling, general & administrative expenses | (8,811 | ) | (9,271 | ) | (10,239 | ) | (10,207 | ) | ||||||||
| Total operating expenses | (10,898 | ) | (10,987 | ) | (12,663 | ) | (12,096 | ) | ||||||||
| OPERATING LOSS | (4,926 | ) | (5,833 | ) | (5,724 | ) | (6,422 | ) | ||||||||
| Interest (expense) income, net | (49 | ) | 102 | (57 | ) | 113 | ||||||||||
| Currency exchange gains (loss), net | 64 | (606 | ) | 75 | (667 | ) | ||||||||||
| LOSS BEFORE INCOME TAXES | (4,911 | ) | (6,337 | ) | (5,707 | ) | (6,976 | ) | ||||||||
| Income tax (expense) credit, net | (103 | ) | (62 | ) | (120 | ) | (69 | ) | ||||||||
| NET LOSS | (5,014 | ) | (6,399 | ) | (5,827 | ) | (7,045 | ) | ||||||||
| Earning per share – basic and diluted | (0.13 | ) | (0.17 | ) | (0.16 | ) | (0.19 | ) | ||||||||
| Average number of shares used in computation of basic and diluted EPS | 37,438,630 | 37,233,406 | 37,438,630 | 37,233,406 | ||||||||||||
NOTE: Translated for convenience of the reader to U.S. dollars at the 2025 average three months’exchange rate of 1 Euro = 1.1620 USD, and 2024 average three months’exchange rate of 1 Euro = 1.1010 USD
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of Euros and U.S. Dollars, except per share data)
| Nine Months Ended: | Nine Months Ended: | |||||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Euros | Euros | $US | $US | |||||||||||||
| Sales of medical equipment | 29,614 | 29,478 | 33,207 | 32,006 | ||||||||||||
| Net sales of RPP and leases | 6,600 | 5,247 | 7,401 | 5,697 | ||||||||||||
| Sales of spare parts, supplies and services | 7,267 | 9,072 | 8,148 | 9,850 | ||||||||||||
| TOTAL REVENUES | 43,480 | 43,797 | 48,755 | 47,553 | ||||||||||||
| Cost of sales | (24,992 | ) | (26,338 | ) | (28,024 | ) | (28,597 | ) | ||||||||
| GROSS PROFIT | 18,488 | 17,458 | 20,732 | 18,956 | ||||||||||||
| Research & development expenses | (6,749 | ) | (5,862 | ) | (7,568 | ) | (6,364 | ) | ||||||||
| Selling, general & administrative expenses | (28,430 | ) | (28,393 | ) | (31,879 | ) | (30,828 | ) | ||||||||
| Total operating expenses | (35,179 | ) | (34,254 | ) | (39,448 | ) | (37,192 | ) | ||||||||
| OPERATING LOSS | (16,691 | ) | (16,796 | ) | (18,716 | ) | (18,236 | ) | ||||||||
| Interest (expense) income, net | (92 | ) | 438 | (104 | ) | 475 | ||||||||||
| Currency exchange gains (loss), net | (572 | ) | (419 | ) | (642 | ) | (455 | ) | ||||||||
| LOSS BEFORE INCOME TAXES | (17,355 | ) | (16,777 | ) | (19,461 | ) | (18,216 | ) | ||||||||
| Income tax (expense) credit, net | (333 | ) | (300 | ) | (374 | ) | (326 | ) | ||||||||
| NET LOSS | (17,689 | ) | (17,077 | ) | (19,835 | ) | (18,542 | ) | ||||||||
| Earning per share – basic and diluted | (0.47 | ) | (0.46 | ) | (0.53 | ) | (0.50 | ) | ||||||||
| Average number of shares used in computation of basic and diluted EPS | 37,417,439 | 37,149,121 | 37,417,439 | 37,149,121 | ||||||||||||
NOTE: Translated for convenience of the reader to U.S. dollars at the 2025 average nine months’ exchange rate of 1 Euro = 1.1213 USD, and 2024 average nine months’ exchange rate of 1 Euro = 1.0858 USD
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of Euros and U.S. Dollars)
| September 30, | December 31, | September 30, | December 31, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Euros | Euros | $US | $US | |||||||||||||
| Cash, cash equivalents and short-term investments | 10,567 | 29,836 | 12,400 | 30,883 | ||||||||||||
| Accounts receivable, net | 19,025 | 20,288 | 22,325 | 21,000 | ||||||||||||
| Inventory | 13,799 | 18,495 | 16,193 | 19,143 | ||||||||||||
| Other current assets | 960 | 1,258 | 1,127 | 1,302 | ||||||||||||
| TOTAL CURRENT ASSETS | 44,352 | 69,876 | 52,044 | 72,328 | ||||||||||||
| Property, plant and equipment, net | 10,016 | 10,336 | 11,753 | 10,699 | ||||||||||||
| Goodwill | 2,412 | 2,412 | 2,830 | 2,496 | ||||||||||||
| Other non-current assets | 4,685 | 3,439 | 5,498 | 3,560 | ||||||||||||
| TOTAL ASSETS | 61,464 | 86,063 | 72,124 | 89,083 | ||||||||||||
| Accounts payable & other accrued liabilities | 16,844 | 21,350 | 19,765 | 22,099 | ||||||||||||
| Deferred revenues, current portion | 6,372 | 6,641 | 7,477 | 6,874 | ||||||||||||
| Short term borrowing | 5,048 | 6,243 | 5,924 | 6,462 | ||||||||||||
| Other current liabilities | 3,140 | 3,577 | 3,685 | 3,702 | ||||||||||||
| TOTAL CURRENT LIABILITIES | 31,404 | 37,811 | 36,851 | 39,138 | ||||||||||||
| Obligations under operating and finance leases non-current | 1,495 | 1,939 | 1,754 | 2,007 | ||||||||||||
| Long-term debt, non-current | 1,009 | 2,162 | 1,183 | 2,238 | ||||||||||||
| Deferred revenues, non-current | 1,202 | 358 | 1,411 | 370 | ||||||||||||
| Other long-term liabilities | 3,034 | 2,897 | 3,560 | 2,999 | ||||||||||||
| TOTAL LIABILITIES | 38,144 | 45,167 | 44,759 | 46,752 | ||||||||||||
| TOTAL SHAREHOLDERS’EQUITY | 23,321 | 40,896 | 27,365 | 42,331 | ||||||||||||
| TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY | 61,464 | 86,063 | 72,124 | 89,083 | ||||||||||||
NOTE: Translated for convenience of the reader to U.S. dollars at the exchange rate of 1 Euro = 1.1734 USD, on September 30, 2025 and at the exchange rate of 1 Euro = 1.0351 USD, on December 31, 2024.
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of Euros and U.S. Dollars)
| Nine Months Ended | Twelve Months Ended | Nine Months Ended | Twelve Months Ended | |||||||||||||
| September 30, | December 31, | September 30, | December 31, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (Euros) | (Euros) | ($US) | ($US) | |||||||||||||
| NET INCOME (LOSS) | (17,689 | ) | (19,018 | ) | (19,835 | ) | (20,520 | ) | ||||||||
| Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1) | 4,591 | 7,395 | 5,148 | 7,979 | ||||||||||||
| OPERATING CASH FLOW | (13,098 | ) | (11,623 | ) | (14,687 | ) | (12,541 | ) | ||||||||
| Increase/Decrease in operating assets and liabilities | 625 | (1,961 | ) | 701 | (2,116 | ) | ||||||||||
| NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES | (12,473 | ) | (13,584 | ) | (13,986 | ) | (14,657 | ) | ||||||||
| Additions to capitalized assets produced by the company and other capital expenditures | (3,577 | ) | (4,120 | ) | (4,011 | ) | (4,445 | ) | ||||||||
| NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES | (3,577 | ) | (4,120 | ) | (4,011 | ) | (4,445 | ) | ||||||||
| NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES | (2,545 | ) | 4,635 | (2,854 | ) | 5,001 | ||||||||||
| NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (673 | ) | (566 | ) | 2,369 | (3,103 | ) | |||||||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (19,268 | ) | (13,635 | ) | (18,483 | ) | (17,204 | ) | ||||||||
(1) including share based compensation expenses for 1,560 thousand of Euros for the nine months ended September 30, 2025 and 3,283 thousand of Euros for the full year ended December 31, 2024.
NOTE: Translated for convenience of the reader to U.S. dollars at the 2025 average nine months’ exchange rate of 1 Euro = 1.1213 USD, and 2024 average twelve months exchange rate of 1 Euro = 1.0790 USD
EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
nine months ended September 30, 2025
(Amounts in thousands of Euros)
| HIFU | ESWL | Distribution | Reconciling | Total After | ||||||||||||||||||||||||||||||||
| Division | Division | Division | Items | Consolidation | ||||||||||||||||||||||||||||||||
| Sales of medical equipment | 13,479 | 1,299 | 14,835 | — | 29,614 | |||||||||||||||||||||||||||||||
| Net sales of RPP and leases | 5,645 | 749 | 206 | — | 6,600 | |||||||||||||||||||||||||||||||
| Sales of spare parts, supplies and services | 2,182 | 3,058 | 2,027 | — | 7,267 | |||||||||||||||||||||||||||||||
| TOTAL REVENUES | 21,306 | 5,106 | 17,068 | — | 43,480 | |||||||||||||||||||||||||||||||
| GROSS PROFIT (% of Net Sales) | 10,428 | 48.9 | % | 2,253 | 44.1 | % | 5,807 | 34.0 | % | — | 18,488 | 42.5 | % | |||||||||||||||||||||||
| Research & development expenses | (6,213 | ) | (118 | ) | (419 | ) | — | (6,749 | ) | |||||||||||||||||||||||||||
| Selling, general & administrative expenses | (18,979 | ) | (777 | ) | (5,889 | ) | (2,786 | ) | (28,430 | ) | ||||||||||||||||||||||||||
| OPERATING PROFIT (LOSS) | (14,763 | ) | 1,358 | (500 | ) | (2,786 | ) | (16,691 | ) | |||||||||||||||||||||||||||