EDAP (NASDAQ: EDAP) posts strong Q1 2026 HIFU growth but wider loss
Rhea-AI Filing Summary
EDAP TMS reported strong growth in its High-Intensity Focused Ultrasound (HIFU) business for the first quarter of 2026 while remaining loss-making. Total revenue reached $17.8 million, up from $14.3 million a year earlier, driven by HIFU revenue of $11.6 million, a 78% year-over-year increase.
The company sold eleven Focal One systems versus six a year ago and saw worldwide disposables revenue grow 54%, helped by 53% growth in U.S. Focal One procedures. Gross margin improved to 45.7%, but higher operating expenses led to a larger net loss of $9.1 million, or ($0.24) per share. EDAP reiterated 2026 guidance, targeting $50–$54 million in HIFU revenue and $22–$26 million from non-core ESWL and distribution.
Positive
- Rapid HIFU segment expansion: HIFU revenue reached $11.6 million in Q1 2026, a 78% year-over-year increase, with eleven Focal One systems sold versus six a year earlier and 54% growth in worldwide disposables revenue.
- Improving profitability at gross margin level: Gross profit margin on net sales rose to 45.7% from 42.0% year over year, helped by favorable product mix and better absorption of fixed costs as HIFU scales.
Negative
- Widening net losses and weaker equity: Net loss increased to $9.1 million, or ($0.24) per share, from $7.4 million, while shareholders’ equity declined to $10.1 million from $19.4 million between December 31, 2025 and March 31, 2026.
- Cash usage and higher leverage: Cash, cash equivalents and short-term investments fell to $15.0 million from $20.5 million, the quarter used $3.0 million in operating cash, and long-term debt rose to $17.6 million from $15.9 million.
Insights
HIFU drives strong growth, but losses and leverage remain key constraints.
EDAP delivered robust Q1 2026 top-line expansion, with total revenue of $17.8 million versus $14.3 million a year earlier. The HIFU segment generated $11.6 million, up 78% year over year, and eleven Focal One systems were sold compared with six in the prior-year quarter.
Mix is shifting toward higher-margin HIFU, lifting consolidated gross margin to 45.7% from 42.0%. However, operating expenses rose to $15.5 million from $12.3 million, widening operating loss to $7.4 million and net loss to $9.1 million, or $0.24 per share. Cash, cash equivalents and short-term investments declined to $15.0 million, while total liabilities increased to $62.0 million and shareholders’ equity fell to $10.1 million.
The company reiterated 2026 guidance, expecting core HIFU revenue of $50.0–$54.0 million, implying 34–45% growth, and $22.0–$26.0 million from non-core ESWL and distribution. Future disclosures in periodic reports will clarify whether strong HIFU momentum can offset continued losses and support the balance sheet.
8-K Event Classification
Key Figures
Key Terms
High-Intensity Focused Ultrasound (HIFU) medical
Focal One Robotic HIFU medical
gross profit margin financial
forward-looking statements regulatory
Annual Report on Form 10-K regulatory
Earnings Snapshot
For 2026, core HIFU revenue is expected between $50.0 million and $54.0 million, representing 34–45% year-over-year growth, and combined non-core ESWL and distribution revenue is expected between $22.0 million and $26.0 million.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________________________________________________
FORM
________________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
_________________________________________________________
(Exact name of registrant as specified in its charter)
__________________________________________________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
| |
| (Address of Principal Executive Offices) (Zip Code) |
(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 |
| |
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 May 7, 2026, EDAP TMS S.A. issued a press release and will hold a conference call regarding its financial results for the quarter ended March 31, 2026. 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 May 7, 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.
| Date: May 7, 2026 | EDAP TMS S.A. |
| /s/ Sanket Shah | |
| Sanket Shah | |
| General Counsel and Corporate Secretary |
Exhibit 99.1
EDAP Reports Strong Financial Results with Record First Quarter HIFU Revenue
Seventh Consecutive Quarter of Year-Over-Year HIFU Revenue Growth
| · | 78% Growth in First Quarter HIFU Revenue Year-Over-Year |
| · | 53% Growth in First Quarter U.S. HIFU Procedures Year-Over-Year |
| · | 83% Growth in First Quarter Focal One Shipments Year-Over-Year Demonstrating Strong Momentum |
| · | Landmark HIFI-2 Study Results Further Strengthen Focal One Robotic HIFU Market Position |
AUSTIN, Texas, May 7, 2026 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today reported financial results for the first quarter of 2026.
“We delivered our strongest HIFU quarter to date, with revenue of $11.6 million, representing 78% year over year growth. U.S. Focal One procedure volumes reached a record high for the company with 53% year over year growth. We are executing well against our 2026 priorities and our results reflect a growing HIFU business. This includes expanded capital sales in key markets along with notable increased utilization across our global installed base,” said Ryan Rhodes, Chief Executive Officer. “Internationally, we secured capital sales in the United Kingdom, France, and Hungary where, for the first time, hospitals are investing in Focal One Robotic HIFU to treat both prostate cancer and deep infiltrating endometriosis."
As previously announced, the landmark HIFI-2 study, published in European Urology Oncology, represents the largest prospective study to date evaluating salvage HIFU treatment following recurrence after failed radiation therapy. The positive study results show promise for use of Focal One HIFU as a breakthrough treatment for this important population of men who have previously been left with limited options that result in long-lasting, debilitating side effects. The publication of the HIFI-2 study further reinforces Focal One’s unique position as a non-invasive, organ-sparing, and function-preserving treatment option for a patient population that has historically faced limited therapeutic alternatives beyond palliative care.
First Quarter 2026 Results
High-Intensity Focused Ultrasound (HIFU) Business
Total revenue in the HIFU business for the first quarter of 2026 was $11.6 million, compared to $6.5 million for the same period in 2025, representing an increase of 78% year over year. The Company sold eleven Focal One systems during the quarter, versus six system sales in the same period in 2025, representing a year-over-year growth of 83%. Worldwide disposables revenue grew 54% year over year, driven primarily by 53% 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 first quarter of 2026 was $6.2 million, compared to $7.8 million for the same period in 2025. The year over year decline reflects the Company’s strategic decision to focus on the high-growth, high margin opportunity in focal therapy through its Focal One Robotic HIFU platform.
Company
Total worldwide revenue for the first quarter of 2026 was $17.8 million, compared to $14.3 million for the same period in 2025. Gross profit margin on net sales was 45.7%, up from 42.0% for the same period in 2025. 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 first quarter of 2026 were $15.5 million, compared to $12.3 million for the same period in 2025.
Operating loss for the first quarter of 2026 was $7.4 million, compared to $6.3 million for the same period in 2025.
Net loss for the first quarter of 2026 was $9.1 million, or ($0.24) per share, compared to $7.4 million, or ($0.20) per share, for the same period in 2025.
2026 Financial Guidance
The Company is reiterating its previously issued revenue guidance. The Company's core HIFU business revenue is expected to be in the range of $50.0 million to $54.0 million, representing 34% to 45% year-over-year growth. Revenue for the Company’s combined non-core ESWL and Distribution business is expected to be in the range of $22.0 million to $26.0 million.
Upcoming Meetings and Events
| · | American Urological Association (AUA) Annual Meeting: May 15-18 in Washington D.C. |
| · | Investor Day: Monday, June 1, 2026 from 8:00-10:00am ET at Nasdaq MarketSite in New York City |
| · | Jefferies Global Healthcare Conference: Marriott Marquis, June 4th in New York City. EDAP management will present at 2:00pm ET and will participate in one-on-one meetings with investors |
Conference Call Information
A conference call and webcast to discuss the first quarter 2026 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, May 7, 2026, at 8:30 a.m. Eastern Time |
| Domestic: | 1-800-343-4136 |
| International: | 1-203-518-9843 |
| Passcode (Conf ID): | EDAP | |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1759064&tp_key=77ec2128dc |
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 STATEMENTS OF OPERATIONS BY DIVISION
three months ended March 31, 2026
(Amounts in thousands of U.S. Dollars)
| Three months ended | HIFU | ESWL | Distribution | Reconciling | Total After | |||||||||||||||||||||||||||||||
| March 31, 2026 | Division | Division | Division | Items | Consolidation | |||||||||||||||||||||||||||||||
| Sales of medical equipment | $ | 8,256 | $ | 277 | $ | 3,846 | — | $ | 12,379 | |||||||||||||||||||||||||||
| Net sales of RPP and leases | 2,492 | 224 | 91 | — | 2,808 | |||||||||||||||||||||||||||||||
| Sales of spare parts, supplies and services | 845 | 1,031 | 749 | — | 2,626 | |||||||||||||||||||||||||||||||
| TOTAL REVENUES | $ | 11,593 | $ | 1,533 | $ | 4,686 | — | $ | 17,812 | |||||||||||||||||||||||||||
| GROSS PROFIT (% of Net Sales) | $ | 5,962 | 51.4 | % | $ | 586 | 38.2 | % | $ | 1,597 | 34.1 | % | — | $ | 8,146 | 45.7 | % | |||||||||||||||||||
| Research & development expenses | (2,467 | ) | (46 | ) | (84 | ) | — | (2,597 | ) | |||||||||||||||||||||||||||
| Selling, general & administrative expenses | (9,439 | ) | (218 | ) | (1,282 | ) | (1,976 | ) | (12,915 | ) | ||||||||||||||||||||||||||
| OPERATING PROFIT (LOSS) | ($ | 5,944 | ) | $ | 322 | $ | 231 | ($ | 1,976 | ) | ($ | 7,366 | ) | |||||||||||||||||||||||
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of U.S. Dollars, except per share data)
| Three Months Ended: | ||||||||
| March 31, | March 31, | |||||||
| 2026 | 2025 | |||||||
| $US | $US | |||||||
| Sales of medical equipment | $ | 12,379 | $ | 9,432 | ||||
| Net sales of RPP and leases | 2,808 | 2,273 | ||||||
| Sales of spare parts, supplies and services | 2,626 | 2,563 | ||||||
| TOTAL NET SALES | 17,812 | 14,267 | ||||||
| Other revenues | — | — | ||||||
| TOTAL REVENUES | 17,812 | 14,267 | ||||||
| Cost of sales | (9,666 | ) | (8,274 | ) | ||||
| GROSS PROFIT | 8,146 | 5,993 | ||||||
| Research & development expenses | (2,597 | ) | (2,583 | ) | ||||
| Selling, general & administrative expenses | (12,915 | ) | (9,719 | ) | ||||
| Total operating expenses | (15,512 | ) | (12,302 | ) | ||||
| OPERATING LOSS | (7,366 | ) | (6,309 | ) | ||||
| Interest (expense) income, net | (1,714 | ) | 15 | |||||
| Currency exchange gains (loss), net | 142 | (1,006 | ) | |||||
| LOSS BEFORE INCOME TAXES | (8,938 | ) | (7,300 | ) | ||||
| Income tax (expense) credit, net | (145 | ) | (144 | ) | ||||
| NET LOSS | ($ | 9,083 | ) | ($ | 7,444 | ) | ||
| Earnings per share – Basic & diluted | ($ | 0.24 | ) | ($ | 0.20 | ) | ||
| Average number of shares used in computation of basic & diluted EPS | 37,481,986 | 37,392,086 | ||||||
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of U.S. Dollars)
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| $US | $US | |||||||
| Cash, cash equivalents and short-term investments | $ | 15,012 | $ | 20,452 | ||||
| Accounts receivable, net | 20,328 | 22,583 | ||||||
| Inventory | 13,332 | 12,830 | ||||||
| Other current assets | 1,691 | 1,299 | ||||||
| TOTAL CURRENT ASSETS | $ | 50,364 | $ | 57,164 | ||||
| Property, plant and equipment, net | 13,007 | 13,505 | ||||||
| Goodwill | 2,773 | 2,834 | ||||||
| Other non-current assets | 5,915 | 5,495 | ||||||
| TOTAL ASSETS | $ | 72,059 | $ | 78,997 | ||||
| Accounts payable & other accrued liabilities | 21,846 | 20,692 | ||||||
| Deferred revenues, current portion | 7,819 | 7,098 | ||||||
| Short term borrowing | 5,248 | 5,986 | ||||||
| Other current liabilities | 2,595 | 3,365 | ||||||
| TOTAL CURRENT LIABILITIES | $ | 37,508 | $ | 37,141 | ||||
| Operating and finance lease liabilities, non-current | 2,345 | 2,429 | ||||||
| Long-term debt, non-current | 17,604 | 15,903 | ||||||
| Deferred revenues, non-current | 1,063 | 966 | ||||||
| Other long-term liabilities | 3,439 | 3,145 | ||||||
| TOTAL LIABILITIES | $ | 61,959 | $ | 59,584 | ||||
| TOTAL SHAREHOLDERS’ EQUITY | $ | 10,101 | $ | 19,413 | ||||
| TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY | $ | 72,059 | $ | 78,997 | ||||
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of U.S. Dollars)
| Three Months Ended | Three Months Ended | |||||||
| March 31, | March 31, | |||||||
| 2026 | 2025 | |||||||
| $US | $US | |||||||
| NET INCOME (LOSS) | $ | (9,083 | ) | $ | (7,444 | ) | ||
| Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1) | 3,368 | 1,235 | ||||||
| OPERATING CASH FLOW | (5,715 | ) | (6,209 | ) | ||||
| Increase/Decrease in operating assets and liabilities | 2,743 | 867 | ||||||
| NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES | (2,972 | ) | (5,342 | ) | ||||
| Additions to capitalized assets produced by the company and other capital expenditures | (754 | ) | (1,304 | ) | ||||
| NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES | (754 | ) | (1,304 | ) | ||||
| NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES | (1,372 | ) | (1,254 | ) | ||||
| NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (341 | ) | 1,591 | |||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | $ | (5,440 | ) | $ | (6,309 | ) | ||
(1) including share based compensation expenses for $302 thousand for the three months ended March 31, 2026 and $339 thousand for the three months ended March 31, 2025.