Form 8-K

8-K — EDAP TMS SA

Accession: 0001171843-26-003113

Filed: 2026-05-07

Period: 2026-05-07

CIK: 0001041934

SIC: 3845 (ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — f8k_050726.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (exh_991.htm)

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0001041934

2026-05-07

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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): May 7,

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 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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: exh_991.htm · Sequence: 2

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

Items

Consolidation

Sales of medical equipment

$ 8,256

$ 277

$ 3,846

—

$ 12,379

Net sales of RPP and leases

2,492

224

—

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,

2026

2025

$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 )

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

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

March 31,

2026

2025

$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.

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May 07, 2026

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration