EDAP Reports Strong Financial Results with Record First Quarter HIFU Revenue
Rhea-AI Summary
EDAP (Nasdaq: EDAP) reported first quarter 2026 results with record HIFU revenue of $11.6 million, up 78% year over year. The company sold 11 Focal One systems (+83% YoY) and U.S. procedures rose 53% YoY. Total revenue was $17.8 million.
Gross margin improved to 45.7%, operating loss was $7.4 million, and net loss was $9.1 million or ($0.24) per share. 2026 HIFU revenue guidance remains $50.0M–$54.0M.
Positive
- HIFU revenue +78% YoY to $11.6M
- Focal One system sales increased to 11 units (+83% YoY)
- Gross margin expanded to 45.7% from 42.0%
Negative
- Net loss widened to $9.1M (Q1 2026)
- Operating loss of $7.4M for Q1 2026
- Non-core revenue declined to $6.2M from $7.8M
Key Figures
Market Reality Check
Peers on Argus
EDAP gained 4.2% pre-news while peers were mixed: YI +2.7%, OMI +2.19%, COSM +0.54%, QIPT flat, and ZYXI down 37.34%, indicating a stock-specific move.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 06 | Q3 2025 earnings | Positive | -4.3% | Strong Q3 HIFU growth, higher margins, narrower net loss, new credit facility. |
| May 15 | Q1 2025 earnings | Negative | -18.5% | Record Focal One placements but total revenue decline and wider net loss. |
| Mar 27 | Q4/FY 2024 earnings | Positive | +8.3% | Record Q4 and full-year HIFU revenue with strong procedure growth and trials. |
| Nov 07 | Q3 2024 earnings | Positive | -3.7% | Double-digit revenue and HIFU growth but ongoing operating and net losses. |
| Aug 28 | Q2 2024 earnings | Positive | +4.2% | Record Q2 revenue, strong U.S. HIFU growth, and advancing clinical programs. |
Earnings releases often highlighted strong HIFU growth but produced mixed to negative price reactions, with an average move of -2.82% across recent earnings reports.
Over the past five earnings-related announcements from Aug 2024 to Nov 2025, EDAP consistently reported record or growing HIFU revenue, improving gross margins, and expanding system placements, while remaining loss-making. Market reactions were mixed, frequently skewing negative despite positive operating trends. Today’s Q1 2026 report, with record HIFU revenue and reiterated growth focus, continues this pattern of emphasizing HIFU-driven expansion alongside ongoing operating and net losses.
Historical Comparison
Across 5 prior earnings releases, EDAP averaged a -2.82% move, often reacting cautiously even when HIFU growth and procedure metrics were strong.
Earnings updates show a steady progression of record HIFU revenue, rising procedure volumes, and improving margins, while the company continues to report net losses and invests in expanding Focal One’s indications.
Regulatory & Risk Context
EDAP has an effective S-3 shelf registration dated 2026-03-26, later amended via an exhibit-only S-3/A and used in connection with a 424B3 prospectus on 2026-03-31, providing flexibility to issue registered securities.
Market Pulse Summary
This announcement highlights record Q1 2026 HIFU revenue of $11.6M, up 78% year-over-year, and total revenue of $17.8M with a higher gross margin of 45.7%. At the same time, net loss widened to $9.1M, and operating expenses rose to $15.5M, continuing an investment-heavy profile. Historically, earnings reactions averaged -2.82%. Investors may track execution versus 2026 HIFU guidance of $50–$54M and usage of the effective S-3 shelf registration.
Key Terms
hifu medical
high-intensity focused ultrasound medical
deep infiltrating endometriosis medical
AI-generated analysis. Not financial advice.
, May 07, 2026 (GLOBE NEWSWIRE) -- 
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-Year53% Growth in First Quarter U.S. HIFU Procedures Year-Over-Year83% 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
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
Non-Core Businesses (ESWL and Distribution)
Total revenue from the Company’s non-core businesses for the first quarter of 2026 was
Company
Total worldwide revenue for the first quarter of 2026 was
Operating expenses for the first quarter of 2026 were
Operating loss for the first quarter of 2026 was
Net loss for the first quarter of 2026 was
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
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 | | | | — | | ||||||||||||||
| 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 | | | | — | | ||||||||||||||
| GROSS PROFIT (% of Net Sales) | | 51.4 | % | | 38.2 | % | | 34.1 | % | — | | 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) | ( | | | ( | ( |
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 | | | ||
| 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 | ( | ( | ||
| Earnings per share – Basic & diluted | ( | ( | ||
| 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 | | | ||
| Accounts receivable, net | 20,328 | 22,583 | ||
| Inventory | 13,332 | 12,830 | ||
| Other current assets | 1,691 | 1,299 | ||
| TOTAL CURRENT ASSETS | | | ||
| Property, plant and equipment, net | 13,007 | 13,505 | ||
| Goodwill | 2,773 | 2,834 | ||
| Other non-current assets | 5,915 | 5,495 | ||
| TOTAL ASSETS | | | ||
| 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 | | | ||
| 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 | | | ||
| TOTAL SHAREHOLDERS’ EQUITY | | | ||
| TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY | | |
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) | ( | ( | ||
| 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 | ( | ( |
(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.
