EDAP TMS SA_March 31, 2026

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended March 31, 2026

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

for the transition period from _________ to _________

Commission File Number: 000-29374

EDAP TMS S.A.

(Exact name of registrant as specified in its charter)

France	98-1644844
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification Number)

Parc d’Activites la Poudrette-Lamartine 4/6, rue du Dauphiné 69120 Vaulx-en-Velin, France (Address of principal executive offices)(Zip Code)

+33 4 72 15 31 50

(Registrant’s telephone number, including area code)

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer ☐	Accelerated filer ☐	Non-accelerated filer ☒
Smaller reporting company ☒	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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of May 6, 2026, the registrant had 37,481,986 ordinary shares, nominal value €0.13 per share, outstanding.

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		Page
PART I. FINANCIAL INFORMATION		4

Item 1.	Financial Statements (unaudited)	4
	Condensed Consolidated Balance Sheets (unaudited)	4
	Condensed Consolidated Statements of Operations (unaudited)	5
	Condensed Consolidated Statements of Comprehensive Loss (unaudited)	6
	Condensed Consolidated Statements of Shareholders’ Equity (unaudited)	7
	Condensed Consolidated Statements of Cash Flows (unaudited)	8
	Notes to Unaudited Condensed Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	22
Item 4.	Controls and Procedures	22

PART II. OTHER INFORMATION		23

Item 1.	Legal Proceedings	23
Item 1A.	Risk Factors	23
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	23
Item 3.	Defaults Upon Senior Securities	23
Item 4.	Mine Safety Disclosures	23
Item 5.	Other Information	23
Item 6.	Exhibits	24

SIGNATURES		25

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Cautionary STATEMENT ON FORWARD-LOOKING INFORMATION

The statements contained in this Quarterly Report on Form 10-Q (this “Quarterly Report”) discuss our future expectations, contain projections of our results of operations or financial condition, and include other forward-looking statements which are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Our actual results may differ materially from those expressed in forward-looking statements made or incorporated by reference into this Quarterly Report.

All statements other than present and historical facts and conditions, including forward-looking statements expressing our beliefs, plans, objectives, business strategy, or future events, performance or results of operations and financial position, are forward-looking statements, which involve estimates, assumptions, risks and uncertainties. Therefore, our actual results and performance may differ materially from those expressed in the forward-looking statements. Forward-looking statements often, although not always, include words or phrases such as the following: “believe,” “plan,” “intend,” “should,” “estimate,” “expect” and “anticipate” or their negative or similar expressions, which reflect our views about future events and financial performance. Forward-looking statements involve inherent risks and uncertainties, including matters not yet known to us or not currently considered material by us.

Actual events or results may differ materially from those expressed or implied in such forward-looking statements as a result of various factors. Factors that could affect future results or cause actual events or results to differ materially from those expressed or implied in forward-looking statements include, but are not limited to:

●

risks associated with our financial position, indebtedness and our ability to raise capital;

●

risks associated with the current worldwide inflationary environment, uncertain worldwide economic, political and financial environment, geopolitical instability, climate change impact, pandemic and each of their related impacts on our business operations;

●

the success of our High Intensity Focused Ultrasound (“HIFU”) technology;

●

the uncertainty of market acceptance for our HIFU devices;

●

the clinical and regulatory status of our devices in various geographical territories;

●

the uncertainty in the regulatory agencies review and approval process for any of our devices and changes in their recommendations and guidance;

●

the impact of government regulation, particularly relating to public healthcare systems and the commercial distribution of medical devices;

●

effects of intense competition in the markets in which we operate;

●

the uncertainty of reimbursement status of procedures performed with our products and their level of reimbursement;

●

the market potential for our HIFU devices;

●

dependence on our strategic suppliers and distribution partners;

●

difficulties to attract and recruit high-level experts in software, design, and development of high technology devices such as our HIFU products;

●

any event or other occurrence that would interrupt operations at our primary production facility;

●

reliance on patents, licenses and key proprietary technologies;

●

cybersecurity risks and incidents;

●

product liability risk;

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●

risk of exchange rate fluctuations, particularly between the euro and the U.S. dollar and between the euro and the Japanese yen;

●

fluctuations in results of operations due to the cyclical nature of demand for medical devices;

●

risks relating to ownership of our securities; and

●

risks relating to securities litigations involving class actions.

You should also consider the information contained in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and included in this Quarterly Report. Any forward-looking statement speaks only as of the date on which that statement is made. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. We qualify all of our forward-looking statements by these cautionary statements.

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements (unaudited)

EDAP TMS S.A. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

As of March 31, 2026 and December 31, 2025

(in thousands of U.S. dollars except share and per share data)
(unaudited)


				March 31,		December 31,
ASSETS		Notes		2026		2025
Current assets
Cash and cash equivalents				15,012		20,452
Current portion of trade accounts and notes receivable, net		3		19,653		21,286
Other receivables				675		1,297
Inventories		4		13,332		12,830
Other assets, current portion				1,691		1,299
Total current assets				50,364		57,164
Non-current assets
Property and equipment, net				10,204		10,394
Operating lease right-of-use assets				2,803		3,111
Intangible assets, net		5		1,722		1,796
Goodwill		5		2,773		2,834
Deposits and other non-current assets				2,082		2,059
Deferred tax assets				1,085		1,094
Net trade accounts and notes receivable, non-current		3		1,026		546
Total assets				72,059		78,997
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities
Trade accounts and notes payable				12,536		11,783
Deferred revenues, current portion				7,819		7,098
Social security and other payroll withholdings taxes				2,170		2,138
Employee absences compensation				1,229		1,189
Income taxes payable				182		193
Other accrued liabilities				5,729		5,389
Short-term borrowings				5,248		5,986
Current obligations under finance leases				222		182
Current portion of operating lease obligations				918		1,063
Current portion of long-term debt		6		1,455		2,120
Total current liabilities				37,508		37,141
Non-current liabilities
Deferred revenues, non-current				1,063		966
Obligations under finance leases				436		355
Operating lease obligations, non-current				1,909		2,075
Long-term debt, non-current		6		17,604		15,903
Other long-term liabilities				3,439		3,145
Total liabilities				61,959		59,584
Shareholders’ equity
Common stock at €0.13, or $0.15 at closing rate par value; 37,751,519 shares authorized and issued and 37,481,986 shares outstanding at March 31, 2026; 37,751,519 shares authorized and issued and 37,481,986 shares outstanding at December 31, 2025				6,071		6,071
Additional paid-in capital				151,616		151,314
Accumulated deficit				(137,699)		(128,616)
Cumulative other comprehensive loss				(8,868)		(8,337)
Treasury stock, at cost 269,533 shares at March 31, 2026 and 269,533 shares at December 31, 2025				(1,019)		(1,019)
Total shareholders’ equity				10,101		19,413
Total liabilities and shareholders’ equity				72,059		78,997

The accompanying notes are an integral part of these condensed consolidated financial statements.

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EDAP TMS S.A. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

For the three months ended March 31, 2026, and 2025

(in thousands of U.S. dollars except share and per share data)
(unaudited)


				Three Months Ended March 31,
		Note		2026		2025
Sales of goods				12,379		9,432
Sales of RPPs & leases				2,808		2,273
Sales of spare parts and services				2,626		2,563
Total revenues		9		17,812		14,267

Cost of goods sold				(5,912)		(5,108)
Cost of RPPs & leases				(1,922)		(1,526)
Cost of spare parts and services				(1,833)		(1,640)
Total cost of sales				(9,666)		(8,274)

Gross profit				8,146		5,993

Research and development expenses				(2,597)		(2,583)
Selling and marketing expenses				(7,124)		(6,066)
General and administrative expenses				(5,791)		(3,653)

Loss from operations				(7,366)		(6,309)
Financial (expense) income, net				(1,714)		15
Foreign currency exchange gain (loss), net				142		(1,006)

Loss before taxes				(8,938)		(7,300)
Income tax expense				(145)		(144)
Net loss				(9,083)		(7,444)
Earning per share - Basic and Diluted				(0.24)		(0.20)
Average number of shares used in computation of basic & diluted loss per share				37,481,986		37,392,086

The accompanying notes are an integral part of the condensed consolidated financial statements.

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EDAP TMS S.A. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

For the three months ended March 31, 2026, and 2025

(in thousands of U.S. dollars)
(unaudited)


	March 31,		March 31,
	2026		2025
Net loss	(9,083)		(7,444)
Other comprehensive loss
Foreign currency translation adjustments	(531)		1,889
Comprehensive loss, net of tax	(9,614)		(5,556)

The accompanying notes are an integral part of these condensed consolidated financial statements.

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EDAP TMS S.A. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

For the three months ended March 31, 2026, and 2025

(in thousands of U.S. dollars except for share amounts)
(unaudited)


						Additional		Retained		Other
		Number		Common		paid-in		Earnings /		comprehensive		Treasury
		of shares		stock		capital		(Loss)		income (loss)		stock		Total
Balance as of December 31, 2024		37,392,086		6,058		148,768		(99,370)		(11,952)		(1,019)		42,485
Net loss		—		—		—		(7,444)		—		—		(7,444)
Translation adjustment		—		—		—		—		1,889		—		1,889
Stock-based compensation		—		—		339		—		—		—		339
Balance as of March 31, 2025		37,392,086		6,058		149,107		(106,815)		(10,063)		(1,019)		37,268

Balance as of December 31, 2025		37,481,986		6,071		151,314		(128,616)		(8,337)		(1,019)		19,413
Net loss		—		—		—		(9,083)		—		—		(9,083)

SEC Form 10-Q filed by EDAP TMS S.A.