Statement of Ownership (sc 13g)
November 07 2019 - 4:31PM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
SCHEDULE
13G
Under
the Securities Exchange Act of 1934
EDAP TMS S.A.
(Name
of Issuer)
American Depositary Shares and Ordinary Shares, nominal value €0.13 per share
(Title
of Class of Securities)
268311107**
(CUSIP
Number)
October 28, 2019
(Date
of Event Which Requires Filing of this Statement)
Check
the appropriate box to designate the rule pursuant to which this Schedule is filed:
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[ ]
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Rule
13d-1(b)
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[X]
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Rule
13d-1(c)
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[ ]
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Rule
13d-1(d)
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*
The remainder of this cover page shall be filled out for a reporting person’s initial filing on this form with respect to
the subject class of securities, and for any subsequent amendment containing information which would alter the disclosures provided
in a prior cover page.
**
There is no CUSIP number assigned to the Ordinary Shares. CUSIP number 268311107 has been assigned to the American Depositary
Shares of the Company, which are quoted on the Nasdaq Global Market under the symbol “EDAP.” Each American Depositary
Share represents 1 Ordinary Share.
The
information required in the remainder of this cover page shall not be deemed to be “filed” for the purpose of Section
18 of the Securities Exchange Act of 1934 (“Act”) or otherwise subject to the liabilities of that section of the Act
but shall be subject to all other provisions of the Act (however, see the Notes).
CUSIP No. 268311107
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13G
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Page 2 of 9 Pages
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NAMES
OF REPORTING PERSONS
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Opaleye
Management Inc.
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1
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I.R.S.
IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
20-5648796
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CHECK
THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)
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(a) [ ]
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2
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(b) [ ]
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SEC
USE ONLY
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3
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CITIZENSHIP
OR PLACE OF ORGANIZATION
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4
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Massachusetts
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NUMBER
OF SHARES
BENEFICIALLY OWNED
BY EACH REPORTING
PERSON WITH:
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SOLE
VOTING POWER
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5
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0
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SHARED
VOTING POWER
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6
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1,520,500 Ordinary Shares, nominal value €0.13 per share (“Ordinary Shares”) (represented by 1,520,500 American
Depositary Shares (“ADS”))
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SOLE
DISPOSITIVE POWER
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7
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0
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SHARED
DISPOSITIVE POWER
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8
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1,520,500 Ordinary Shares (represented by 1,520,500 ADS)
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AGGREGATE
AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
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9
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1,520,500 Ordinary Shares (represented by 1,520,500 ADS)
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CHECK
IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)
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10
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[ ]
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PERCENT
OF CLASS REPRESENTED BY AMOUNT IN ROW (9)
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11
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5.24%
*
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TYPE
OF REPORTING PERSON (SEE INSTRUCTIONS)
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12
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CO
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*
Based upon 28,997,866 Ordinary Shares outstanding on April 12, 2019 as reported by the Issuer on its annual report on Form 20-F
filed with the Securities and Exchange Commission on April 30, 2019. This calculation does not include the exercise or conversion
of outstanding securities of the Issuer.
CUSIP No. 268311107
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13G
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Page 3 of 9 Pages
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NAMES
OF REPORTING PERSONS
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1
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I.R.S.
IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
Opaleye,
L.P.
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CHECK
THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)
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(a)
[ ]
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2
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(b)
[ ]
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SEC
USE ONLY
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3
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CITIZENSHIP
OR PLACE OF ORGANIZATION
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4
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Delaware
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NUMBER
OF SHARES
BENEFICIALLY OWNED
BY EACH REPORTING
PERSON WITH:
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SOLE
VOTING POWER
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5
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0
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SHARED
VOTING POWER
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6
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1,520,500 Ordinary Shares (represented by 1,520,500 ADS)
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SOLE
DISPOSITIVE POWER
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7
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0
|
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SHARED
DISPOSITIVE POWER
|
|
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8
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1,520,500 Ordinary Shares (represented by 1,520,500 ADS)
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AGGREGATE
AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
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9
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1,520,500 Ordinary Shares (represented by 1,520,500 ADS)
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CHECK
IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)
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10
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[ ]
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PERCENT
OF CLASS REPRESENTED BY AMOUNT IN ROW (9)
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11
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5.24%
*
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TYPE
OF REPORTING PERSON (SEE INSTRUCTIONS)
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12
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PN
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*
Based upon 28,997,866 Ordinary Shares outstanding on April 12, 2019 as reported by the Issuer on its annual report on Form 20-F
filed with the Securities and Exchange Commission on April 30, 2019. This calculation does not include the exercise or conversion
of outstanding securities of the Issuer.
CUSIP No. 268311107
|
13G
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Page 4 of 9 Pages
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NAMES
OF REPORTING PERSONS
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1
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I.R.S.
IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
James
Silverman
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CHECK
THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)
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(a) [ ]
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2
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(b) [ ]
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SEC
USE ONLY
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3
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CITIZENSHIP
OR PLACE OF ORGANIZATION
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4
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United
States
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NUMBER
OF SHARES
BENEFICIALLY OWNED
BY EACH REPORTING
PERSON WITH:
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SOLE
VOTING POWER
|
|
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5
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0
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SHARED
VOTING POWER
|
|
|
6
|
1,520,500 Ordinary Shares (represented by 1,520,500 ADS)
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|
SOLE
DISPOSITIVE POWER
|
|
|
7
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0
|
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SHARED
DISPOSITIVE POWER
|
|
|
8
|
1,520,500 Ordinary Shares (represented by 1,520,500 ADS)
|
|
AGGREGATE
AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
|
|
|
9
|
1,520,500 Ordinary Shares (represented by 1,520,500 ADS)
|
|
CHECK
IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)
|
|
|
10
|
[ ]
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PERCENT
OF CLASS REPRESENTED BY AMOUNT IN ROW (9)
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11
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5.24%
*
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TYPE
OF REPORTING PERSON (SEE INSTRUCTIONS)
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12
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IN
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*
Based upon 28,997,866 Ordinary Shares outstanding on April 12, 2019 as reported by the Issuer on its annual report on Form 20-F
filed with the Securities and Exchange Commission on April 30, 2019. This calculation does not include the exercise or conversion
of outstanding securities of the Issuer.
CUSIP No. 268311107
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13G
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Page 5 of 9 Pages
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Item
1(a).
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Name
of Issuer:
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The
name of the issuer is EDAP TMS S.A. (the “Company”).
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Item
1(b).
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Address
of Issuer’s Principal Executive Offices:
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The
Company’s principal executive offices are located at Parc Activite La Poudrette Lamartine, 4/6 Rue du Dauphine, 69120 Vaulx-en-Velin, France.
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Item
2(a).
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Name
of Person Filing.
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This
statement is filed by the entities and persons listed below, who are collectively referred to herein as “Reporting
Persons” with respect to the Ordinary Shares of the Company:
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Opaleye
Fund
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Opaleye,
L.P. (the “Opaleye Fund”), a private fund formed in the state of Delaware.
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Investment
Manager
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Opaleye Management Inc. (the “Investment Manager”), with respect to the Ordinary
Shares held by the Opaleye Fund, a private fund to which the Investment Manager serves as investment manager. The Investment Manager
also serves as a portfolio manager for a separate managed account (the “Managed Account”) and may be deemed
to indirectly beneficially own securities owned by the Managed Account. The Investment Manager disclaims beneficial ownership of
the shares held by the Managed Account.
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Reporting
Individual
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Mr.
James Silverman (the “Reporting Individual”), with respect to the Ordinary Shares held by the Opaleye
Fund. Mr. Silverman is the President of the Investment Manager.
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Item
2(b).
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Address
of Principal Business Office or, if None, Residence.
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One
Boston Place, 26th Floor
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Boston,
Massachusetts 02108
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Item
2(c).
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Citizenship.
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Citizenship
is set forth in Row 4 of the cover page for each Reporting Person and is incorporated herein by reference for each such Reporting
Person.
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Item
2(d).
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Title
of Class of Securities.
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Ordinary
Shares, nominal value €0.13 per share (“Ordinary Shares”) represented
by American Depositary Shares (“ADS”), each of which represents one
Ordinary Share.
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Item
2(e).
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CUSIP
Number.
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There
is no CUSIP number assigned to the Ordinary Shares. CUSIP number 268311107 has been assigned
to the ADS, which are quoted on the Nasdaq Global Market under the symbol “EDAP”.
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CUSIP No. 268311107
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13G
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Page 6 of 9 Pages
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Item
3.
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If
This Statement is Filed Pursuant to Rule 13d-1(b), or 13d-2(b) or (c), Check Whether
the Person Filing is a:
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(a)
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[ ]
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Broker
or dealer registered under Section 15 of the Exchange Act.
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(b)
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[ ]
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Bank
as defined in Section 3(a)(6) of the Exchange Act.
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(c)
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[ ]
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Insurance
company as defined in Section 3(a)(19) of the Exchange Act.
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(d)
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[ ]
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Investment
company registered under Section 8 of the Investment Company Act.
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(e)
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[ ]
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An
investment adviser in accordance with Rule 13d-1(b)(1)(ii)(E);
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(f)
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[ ]
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An
employee benefit plan or endowment fund in accordance with Rule 13d-1(b)(1)(ii)(F);
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(g)
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[ ]
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A
parent holding company or control person in accordance with Rule 13d-1(b)(1)(ii)(G);
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(h)
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[ ]
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A
savings association as defined in Section 3(b) of the Federal Deposit Insurance Act;
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(i)
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[ ]
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A
church plan that is excluded from the definition of an investment company under Section 3(c)(14) of the Investment Company
Act;
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(j)
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[ ]
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A
non-U.S. institution in accordance with Rule 13d-1(b)(1)(ii)(J);
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(k)
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[ ]
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Group,
in accordance with Rule 13d-1(b)(1)(ii)(K).
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If
filing as a non-U.S. institution in accordance with Rule 13d-1(b)(1)(ii)(J), please specify the type of institution: _________________
Item
4. Ownership.
(a)
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Amount beneficially owned:
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Opaleye Management
Inc. — 1,520,500 Ordinary Shares (represented by 1,520,500 ADS)*
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Opaleye, L.P. — 1,520,500 Ordinary Shares (represented by 1,520,500 ADS)*
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James Silverman — 1,520,500 Ordinary Shares (represented by 1,520,500 ADS)*
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* Includes 49,500 Ordinary Shares (represented by 49,500 ADS) held by the Managed Account
(b)
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Percent
of class:
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Opaleye Management Inc. — 5.24%**
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Opaleye, L.P. — 5.24%**
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James Silverman — 5.24%**
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* Based upon 28,997,866 Ordinary Shares outstanding
on April 12, 2019 as reported by the Issuer on its annual report on Form 20-F filed with the Securities and Exchange Commission
on April 30, 2019. This calculation does not include the exercise or conversion of outstanding securities of the Issuer.
CUSIP No. 268311107
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13G
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Page 7 of 9 Pages
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(c)
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Number of shares as to which the person has:
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(i)
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Sole power to vote or to direct the vote:
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Opaleye
Management Inc. — 0 Ordinary Shares
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Opaleye,
L.P. — 0 Ordinary Shares
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James
Silverman — 0 Ordinary Shares
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(ii)
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Shared
power to vote or to direct the vote:
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Opaleye
Management Inc. — 1,520,500 Ordinary Shares (represented by 1,520,500 ADS)*
|
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Opaleye,
L.P. — 1,520,500 Ordinary Shares (represented by 1,520,500 ADS)*
|
|
|
James
Silverman — 1,520,500 Ordinary Shares (represented by 1,520,500 ADS)*
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*
Includes 49,500 Ordinary Shares (represented by 49,500 ADS) held by the Managed Account
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(iii)
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Sole
power to dispose or to direct the disposition of:
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Opaleye
Management Inc. — 0 Ordinary Shares
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Opaleye,
L.P. — 0 Ordinary Shares
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James
Silverman — 0 Ordinary Shares
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(iv)
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Shared
power to dispose or to direct the disposition of:
|
|
|
|
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Opaleye Management Inc. — 1,520,500 Ordinary Shares (represented by 1,520,500 ADS)*
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Opaleye, L.P. — 1,520,500 Ordinary Shares (represented by 1,520,500 ADS)*
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James Silverman — 1,520,500 Ordinary Shares (represented by 1,520,500 ADS)*
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*
Includes 49,500 Ordinary Shares (represented by 49,500 ADS) held by the Managed Account
Item
5. Ownership of Five Percent or Less of a Class.
If
this statement is being filed to report the fact that as of the date hereof the Reporting Persons have ceased to be the beneficial
owners of more than five percent of the class of securities, check the following [ ].
Item
6. Ownership of More than Five Percent on Behalf of Another Person.
Not
applicable.
Item
7. Identification and Classification of the Subsidiary Which Acquired the Security Being Reported by the Parent Holding Company
or Control Person.
Not
applicable.
Item
8. Identification and Classification of Members of the Group.
Not
applicable.
Item
9. Notice of Dissolution of Group.
Not
applicable.
CUSIP No. 268311107
|
13G
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Page 8 of 9 Pages
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Item
10. Certification.
By signing below I certify that, to the best of my knowledge and belief, the securities referred to above were not acquired
and are not held for the purpose of or with the effect of changing or influencing the control of the issuer of the securities
and were not acquired and are not held in connection with or as a participant in any transaction having that purpose or effect.
CUSIP No. 268311107
|
13G
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Page 9 of 9 Pages
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SIGNATURE
After
reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true,
complete and correct.
Date:
November 7, 2019
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By:
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/s/
James Silverman
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James
Silverman
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Opaleye,
L.P.
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Date:November 7, 2019
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By:
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/s/
James Silverman
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Name:
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James
Silverman
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Title:
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Managing
Member of Opaleye GP
LLC,
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the General Partner of Opaleye, L.P.
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Opaleye
Management Inc.
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Date:
November 7, 2019
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By:
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/s/
James Silverman
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Name:
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James
Silverman
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Title:
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President
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JOINT
FILING AGREEMENT
This Joint Filing Agreement, dated November 7, 2019, is entered into by and among Opaleye Management Inc., a Massachusetts
corporation, Opaleye, L.P., a Delaware limited partnership and James Silverman, an individual (collectively referred to herein
as (the “Filers”). Each of the Filers may be required to file with the U.S. Securities and Exchange Commission a statement
on Schedule 13G with respect to the Ordinary Shares (represented by ADS, each of which represents one Ordinary Share) of the
Issuer beneficially owned by them from time to time. Pursuant to and in accordance with Rule 13(d)(1)(k) promulgated under
the Securities Exchange Act of 1934, as amended, the Filers hereby agree to file a single statement on Schedule 13G and/or
13D (and any amendments thereto) on behalf of each of such parties, and hereby further agree to file this Joint Filing Agreement
as an exhibit to such statement, as required by such rule. This Joint Filing Agreement may be terminated by any of the Filers
upon one week’s prior written notice or such lesser period of notice as the Filers may mutually agree.
DATED:
November 7, 2019
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By:
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/s/
James Silverman
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James
Silverman
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Opaleye,
L.P.
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By:
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/s/
James Silverman
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Name:
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James
Silverman
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Title:
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Managing
Member of Opaleye GP
LLC,
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the General Partner of Opaleye, L.P.
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Opaleye
Management Inc.
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By:
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/s/
James Silverman
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Name:
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James
Silverman
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Title:
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President
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