False
0001041934
0001041934
2026-01-12
2026-01-12
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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): January
12, 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 January 12, 2026, EDAP TMS S.A. (“EDAP” or the “Company”) issued a press release announcing select preliminary
unaudited financial and operational results for the fourth quarter and full fiscal year ended December 31, 2025 and disclosing select
guidance for 2026. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
On January 12, 2026, the Company plans to present the presentation attached hereto as Exhibit 99.2 (the “Presentation”)
to analysts and investors.
The furnishing of the Presentation is not an admission as to the materiality of any information therein. The information contained
in the Presentation is summary information that is intended to be considered in the context of more complete information included in EDAP’s
filings with the U.S. Securities and Exchange Commission (the “SEC”) and other public announcements that EDAP has made and
may make from time to time by press release or otherwise. EDAP undertakes no duty or obligation to update or revise the information contained
in this report, although it may do so from time to time as its management believes is appropriate. For important information about forward
looking statements, see the slide titled “Forward-Looking Statements & Disclaimer” in the Presentation.
The information in Item 2.02 and Item 7.01 of this Current Report on Form 8-K and Exhibits 99.1 and 99.2 attached hereto 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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities
Act”), or incorporated by reference in any filing of EDAP under the Securities Act or the Exchange Act, whether made before or after
the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference
in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| 99.1 |
|
Press Release dated January 12, 2026 |
| 99.2 |
|
EDAP Investor Presentation |
| 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.
| |
EDAP TMS S.A |
| |
|
|
| |
|
|
| Date: January 12, 2026 |
By: |
/s/ Sanket Shah |
| |
|
Sanket Shah |
| |
|
General Counsel and Corporate Secretary |
| |
|
|
