Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7): ____
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: June 5, 2018
EDAP TMS S.A.
/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER
Dear EDAP Shareholders,
In 2017, we continued to expand our business worldwide
and to record accomplishments in our global activities. Our 2017 consolidated revenue amounted 35.7 million Euros, stable with
2016’s. While we recorded weaker HIFU device sales over the year, we are encouraged by our increasing HIFU treatment driven
revenues. Adoption of HIFU continues to grow as more physicians gain comfort and experience with this minimally invasive treatment
option.
In the U.S., 2017 CMS’s
issuance of a C-Code to reimburse HIFU for prostate tissue ablation and Cigna’s recent decision to reimburse HIFU as a salvage
therapy also provide important validation for our technology. While today June 1st
,
we are still expecting an FDA
decision on the clearance of our Focal One device, we did have our Ablatherm Fusion device approved by the FDA in October 2017.
Ablatherm Fusion complements our HIFU device offering as it provides better treatment accuracy in merging MRI and ultrasound images.
We do believe that focal therapy is the future of prostate cancer treatment and we very much look forward to FDA clearance to expand
HIFU offering in the U.S.
Internationally, we also
pursued the promotion of our Focal One HIFU device and initiated the process to roll out a clinical study in Japan in view of its
Japanese clearance.
Turning to our lithotripsy business, we continued
to see solid growth in 2017 driven primarily by strong device sales. Lithotripsy remains a relatively mature market but it is dynamic
and subject to a burgeoning replacement cycle. Internationally, we also continued to see solid growth in our distribution business.
This activity is primarily in France and Japan, although we are looking at opportunities to expand further by reaching new partnerships
and agreements with companies offering products bringing clear synergies with our manufactured ranges of products and our expansion
strategies.
2018 will prove to be an important year for EDAP
with multiple pending milestones including a conclusion to the FDA review of Focal One, the expansion of our HIFU product offering
and increase in HIFU reimbursement coverage. We will also pursue our clinical development programs beyond urology with a long-term
objective of making HIFU a standard of care procedure for minimally invasive ablation of soft tissue available in each operating
room.
We would like to thank our shareholders and investors
for your continued support and confidence in EDAP’s long-term success.
Sincerely,
/s/ Philippe Chauveau
Chairman of the Board
EDAP TMS S.A.
June 1
st
, 2018
Non binding, unofficial English translation
for information purposes only. Original in French.
EDAP TMS
A corporation with a share capital
of 3,817,891.22 euros
Registered office: Parc d’activité
La Poudrette Lamartine
4, rue du Dauphiné - 69120
Vaulx en Velin, France
Lyon Registry of Commerce 316 488
204
Vaulx-en-Velin,
June 1
st
, 2018
NOTICE
On Friday June 29, 2018, the shareholders
are convened to attend an Ordinary General Meeting of the shareholders of EDAP TMS S.A., to be held:
at 10:30 am,
at EDAP TMS’s headquarters
4, rue du Dauphiné,
69120 Vaulx-en-Velin, France
to consider the following
agenda:
|
1.
|
Reading and approval of the special report of the Statutory Auditor
on the agreements referred to in article L. 225-38 of the French Commercial Code;
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|
2.
|
Reading of the Board of Directors' report on the activity, the
situation and the financial statements of the Company relating to the fiscal year ended December 31, 2017; reading of the Board
of Directors’ report on Corporate Governance, reading of the Board of Directors' special report pursuant to Article L. 225-184,
paragraph 1 of the French Commercial Code; reading of the Statutory Auditor's report relating to the annual accounts for the fiscal
year ended December 31, 2017; reading of the Statutory Auditor’s report relating to the consolidated financial statements
(US GAAP); approval of the statutory accounts and of the consolidated financial statements (US GAAP) for the fiscal year ended
December 31, 2017
;
granting of a release to the members of the Board of Directors for
their management;
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3.
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Allocation of net loss for the fiscal year ended December 31,
2017;
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4.
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Determination of attendance fees to be allocated to the Board
of Directors;
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5.
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Appointment of a new Statutory Auditor and a new Alternate Statutory
Auditor.
|
Yours sincerely,
The Board of Directors
Note:
As
per Depositary Agreement dated July 31, 1997 and amendment dated April 7, 2008, signed between Bank of New York Mellon (the “Depositary”)
and the Company, if no voting Instruction Form is received by the Depositary from a Holder with respect to any of the Securities
represented by American Depositary Shares (“ADSs”) on or before the Receipt Date (Record Date), or if the voting Instruction
Form is improperly completed or blank, or if the voting instructions included in the voting Instruction Form are illegible or
unclear, such Holder of ADSs shall be deemed to have instructed the Depositary to vote such ADSs and the Depositary shall vote
such ADSs in favor of any resolution proposed or approved by the Board of Directors of the Company and against any resolution
not so proposed or approved.
EDAP TMS
- Agenda/notice for the AGO - June 29 2018 ENGLISH
Non-binding, unofficial English translation
for information purposes only. Only the original version in French has legal force.
EDAP TMS
A corporation with a share capital
of 3,817,891.22 euros
Registered office : 4, rue
du Dauphiné - Parc d’activité la Poudrette Lamartine
69120 Vaulx-en-Velin (France)
Lyon Trade and Companies Register
Number 316 488 204
Report
of the Board of Directors to the Ordinary Shareholders’ Meeting of June 29, 2018
Ladies and Gentlemen,
We have called this Ordinary Shareholders’ Meeting to vote
on the following agenda:
|
1.
|
Reading and approval of the special report of the Statutory Auditor
on the agreements referred to in article L. 225-38 of the French Commercial Code;
|
|
2.
|
Reading of the Board of Directors' report on the activity, the
situation and the financial statements of the Company relating to the fiscal year ended December 31, 2017; reading of the Board
of Directors’ report on Corporate Governance, reading of the Board of Directors' special report pursuant to Article L. 225-184,
paragraph 1 of the French Commercial Code; reading of the Statutory Auditor's report relating to the annual accounts for the fiscal
year ended December 31, 2017; reading of the Statutory Auditor’s report relating to the consolidated financial statements
(US GAAP); approval of the statutory accounts and of the consolidated financial statements (US GAAP) for the fiscal year ended
December 31, 2017; granting of a release to the members of the Board of Directors for their management;
|
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3.
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Allocation of net loss for the fiscal year ended December 31,
2017;
|
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4.
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Determination of attendance fees to be allocated to the Board
of Directors;
|
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5.
|
Appointment of a new Statutory Auditor and a new Alternate Statutory
Auditor.
|
Management report on the Company’s activity
for the fiscal year ended December 31, 2017:
We invite you to read the Board
of Directors’ management report available pursuant to French laws and regulations and the Company’s 2017 Annual Report
on the 2017 consolidated accounts, which is available on the Company’s website www.edap-tms.com, in the “Investor Relations”
– “Financial Information” section.
Please note that the mandate of
the Company’s Statutory Auditor PriceWaterhouseCoopers Audit and its Alternate Statutory Auditor terminates on the date of
the present General Meeting. Upon the Company’s Audit Committee recommendation, the Board of Directors recommends not to
renew the mandate of PriceWaterhouseCoopers Audit and to appoint KPMG audit, as Statutory Auditor of the Company, for a period
of six fiscal years.
In
this context, we ask you to vote on the aforementioned resolutions submitted to you by your Board of Directors.
EDAP TMS – Board report to AGM – June 29, 2018
|
1
|
This is a free translation from the French language and is supplied
solely for information purposes. Only the original version in French language has legal force.
EDAP
- TMS
A corporation with a share capital
of
3,817,891.22 euros
Registered office: Parc d’activité La Poudrette Lamartine
4, rue du Dauphiné - 69120 Vaulx-en-Velin, France
Lyon Registry of Commerce 316 488 204
DRAFT RESOLUTIONS TO BE SUBMITTED
TO THE ORDINARY SHAREHOLDERS’ MEETING HELD
ON JUNE 29, 2018
Shareholders are invited to attend the Ordinary Shareholders’
Meeting of EDAP-TMS S.A. (the “Company”) on June 29, 2018, at 10.30 am., at the Company’s offices, 4 Rue du Dauphiné,
69120, Vaulx-en-Velin, France.
The shareholders will deliberate on the following agenda:
|
1.
|
Reading and approval of the special report of the Statutory Auditor on the agreements referred
to in article L. 225-38 of the French Commercial Code;
|
|
2.
|
Reading of the Board of Directors' report on the activity, the situation and the financial statements
of the Company relating to the fiscal year ended December 31, 2017; reading of the Board of Directors’ report on Corporate
Governance, reading of the Board of Directors' special report pursuant to Article L. 225-184, paragraph 1 of the French Commercial
Code; reading of the Statutory Auditor's report relating to the annual accounts for the fiscal year ended December 31, 2017; reading
of the Statutory Auditor’s report relating to the consolidated financial statements (US GAAP); approval of the statutory
accounts and of the consolidated financial statements (US GAAP) for the fiscal year ended December 31, 2017; granting of a release
to the members of the Board of Directors for their management;
|
|
3.
|
Allocation of net loss for the fiscal year ended December 31, 2017;
|
|
4.
|
Determination of attendance fees to be allocated to the Board of Directors;
|
|
5.
|
Appointment of a new Statutory Auditor and a new Alternate Statutory Auditor.
|
* * *
FIRST RESOLUTION
(
Reading and approval of the special
report of the Statutory Auditor on the agreements referred to in Article L. 225-38 of the French Commercial Code)
After hearing the Statutory Auditor's special report relating to
the agreements referred to in article L.225-38 of the French Commercial Code (related party transactions), the Shareholders’
Meeting approves the terms of the report, mentioning that there is no such agreements.
Draft of resolutions EDAP TMS AGO –
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/3
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June 29, 2018
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SECOND RESOLUTION
(
Reading of the Board of Directors'
report on the activity, the situation and the financial statements of the Company relating to the fiscal year ended December 31,
2017; reading of the Board of Directors’ report on Corporate Governance, reading of the Board of Directors' special report
pursuant to Article L. 225-184, paragraph 1 of the French Commercial Code; reading of the Statutory Auditor's report relating to
the annual accounts for the fiscal year ended December 31, 2017; reading of the Statutory Auditor’s report relating to the
consolidated financial statements (US GAAP); approval of the statutory accounts and of the consolidated financial statements (US
GAAP) for the fiscal year ended December 31, 2017; granting of a release to the members of the Board of Directors for their management)
The Shareholders’ Meeting, acting in accordance with the quorum
and majority criteria required for Ordinary Shareholders’ Meetings, and after having been read:
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-
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the Board of Directors' report on the activity, the situation and the financial statements of the
Company relating to the fiscal year ended
December 31, 2017,
|
|
-
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the Board of Directors' special report on stock-options pursuant to Article L. 225-37, a16 and
L.225-68 a16 of the French Commercial Code,
|
|
-
|
the Board of Directors' special report on stock-options pursuant to Article L. 225-184 paragraph
1 of the French Commercial Code,
|
|
-
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the Statutory Auditor's report relating to the annual accounts relating to the fiscal year ended
December 31, 2017,
|
|
-
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the Statutory Auditor’s report relating to the consolidated financial statements prepared
in accordance with U.S. generally accepted accounting principles (US GAAP) applying to companies listed on the Nasdaq.
|
Approves the annual accounts, i.e., the balance sheet, income statement
and the related note as of and for the period ended December 31, 2017 as they have been presented, together with the transactions
transcribed in the aforesaid financial statements and summarized in such reports.
Approves the consolidated financial statements relating to the fiscal
year ended December 31, 2017 established in accordance with US GAAP as applied to companies listed on the Nasdaq market, as they
have been presented in the 20-F Report filed with SEC on April 30, 2018, together with the transactions transcribed in the aforesaid
financial statements and summarized in such report.
The Shareholders’ Meeting therefore grants a release to all
members of the Board of Directors for their management during the fiscal year 2017.
THIRD RESOLUTION
(
Allocation of net loss for the fiscal
year ended December 31, 2017)
The Shareholders’ Meeting, in accordance with the quorum and
majority criteria required for Ordinary Shareholders’ Meetings, acknowledges that the Company has recorded a net loss (not
consolidated) of €783,715 during fiscal year ended December 31, 2017.
The Shareholders’ Meeting, after reading the Board of Directors
report, decides to allocate the total net loss €783,715 amount to the cumulated losses account, increasing this account from
(€13,807,060) to (€14,590,775).
Pursuant to Article 243 bis of the French Tax Code, the Shareholders’
Meeting takes note that no dividend has been paid during the last three fiscal years.
The Shareholders’ Meeting, pursuant to the Board of Directors'
report, in accordance with article 223 quarter of the French Tax Code, takes note that no expenses, nor charges concerned by article 39-4
of this Code, nor theoretical tax amount, will be recorded by the Company.
Draft of resolutions EDAP TMS AGO –
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June 29, 2018
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FOURTH RESOLUTION
(
Determination of attendance
fees to be allocated to the Board of Directors)
The General Meeting, in accordance with the quorum and majority
criteria required for Ordinary Shareholders Meetings, sets the attendance fees to be allocated to the Board of Directors for the
fiscal year ended December 31
st
, 2017 at a total amount of €108,000.00.
FIFTH RESOLUTION
(Appointment of a new Statutory Auditor
and a new Alternate Statutory Auditor)
The General Meeting, in accordance with the quorum and majority
criteria required for Ordinary Shareholders Meetings and after hearing the Board of Directors' management report, acknowledges
that the mandate of the Company’s Statutory Auditor and Alternate Statutory Auditor terminates on the date of the present
General Meeting.
Consequently, and after hearing the Board of Directors' management
report, the General Meeting decides:
|
-
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not to renew the mandates of PriceWaterhouseCoopers Audit and of Mme Anik Chaumartin, respectively Statutory Auditor and Alternate
Statutory Auditor of the Company;
|
|
(i)
|
KPMG, with its registered office at 2, Avenue Gambetta, Tour Eqho, 92066 Paris la Défense
CEDEX, registered with the Commercial Registry of Nanterre under number 775726417, as Statutory Auditor of the Company;
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(ii)
|
Salustro Reydel, with its registered office at 2, Avenue Gambetta, Tour Eqho, 92066 Paris la Défense
CEDEX registered with the Commercial Registry of Nanterre under number 652044371, as Alternate Statutory Auditor of the Company.
|
for a period of six fiscal years to be terminated at the end of the General Meeting to
be called in the course of year 2024 in order to approve the financial statements of the Company for the fiscal year ended December
31, 2023.
*******
The Shareholders’ Meeting grants all powers to the holder
of an original, a copy or an extract of these meeting minutes in order to carry out all required or necessary filing publicity
and other formalities.
Draft of resolutions EDAP TMS AGO –
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/3
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June 29, 2018
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