f6k_052814.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

EDAP TMS S.A Files on

May 28, 2014


EDAP TMS S.A
Parc Activité La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France


Commission File Number: 0-29374



Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
 
Form 20-F .........X........ 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): .......

 
THIS REPORT ON FORM 6-K SHALL BE DEEMED TO BE INCORPORATED BY REFERENCE IN THE REGISTRATION STATEMENT ON FORM F-3 (NO. 333-195435) OF EDAP TMS S.A. AND TO BE PART THEREOF FROM THE DATE ON WHICH THIS REPORT IS FURNISHED, TO THE EXTENT NOT SUPERSEDED BY DOCUMENTS OR REPORTS SUBSEQUENTLY FILED OR FURNISHED.

 
 

 
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: May 28, 2014
EDAP TMS S.A.
 
 
/s/ ERIC SOYER
ERIC SOYER
CHIEF FINANCIAL OFFICER
exh_991.htm
EXHIBIT 99.1
 
EDAP TMS S.A.
 
RECENT DEVELOPMENTS AS OF MAY 27, 2014
 
Note to potential investors. This consolidated summary of certain recent developments (this “Summary”) includes information that originally appeared in four separate press releases published by EDAP TMS S.A. (the “Company”) on, respectively, May 27, May 22, May 15 and April 21, 2014, each of which was furnished to the U.S. Securities and Exchange Commission (the “SEC”) on a Form 6-K on the date it was published as a press release.

Certain additional important information is included at the end of this Summary under the captions “Forward-looking Statements” and “Additional Information”. Potential investors are encouraged to read these sections carefully for information concerning forward-looking statements, as well as for details on how to obtain additional information in regards to a registration statement filed by the Company with the SEC.
 
1.  Press Release dated May 27, 2014
 
EDAP Outlines Key Events Scheduled in the Ablatherm-HIFU PMA Process
 
EDAP TMS SA provided additional details on key events scheduled as part of the U.S. Food and Drug Administration (FDA) Pre-Market Approval (“PMA”) process for its Ablatherm-HIFU device for the treatment of localized prostate cancer.
 
In addition to the previously announced panel of experts that is scheduled to review the Ablatherm-HIFU device and provide a recommendation based on the clinical data submitted to the FDA, the Company has additional milestones to achieve as part of the PMA application process. The first relates to an engineering, manufacturing and quality assessment of EDAP’s factory, which consists of a routine inspection by the FDA. This has now been confirmed and scheduled to take place June 23 to June 26, 2014. In parallel there is a clinical data validation process, which includes an FDA audit of the investigation sites. The Company has received confirmation and scheduling of the “foreign” site’s audit which will be conducted in the course of July 2014.
 
2.  Press Release dated May 22, 2014
 
EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
 
The U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will review the Pre-Market Approval (“PMA”) application for EDAP's Ablatherm-HIFU device for the treatment of localized prostate cancer on July 30, 2014.
 
 
 

 
3.  Press Release dated May 15, 2014
 
EDAP Reports First Quarter 2014 Results
 
 
·
Record revenue of EUR 7.8 million for the first quarter 2014, a 31% year-over-year increase
 
·
First quarter 2014 gross margin up nine points to 46%
 
·
Second sequential quarter with positive operating income
 
·
Ablatherm HIFU PMA moves to panel preparation phase with FDA
 
·
Reimbursement of HIFU for prostate cancer granted in France
 
·
HIFU officially recommended for prostate cancer by European Association of Urology
 
First Quarter 2014 Results
 
 
·
Total revenue for the first quarter 2014 was EUR 7.8 million (USD 10.6 million), a 31% year-over-year increase compared to EUR 5.9 million (USD 7.8 million) for the first quarter 2013.
 
·
Total revenue for the HIFU division was EUR 3.3 million (USD 4.5 million) for the first quarter 2014, compared to EUR 1.4 million (USD 1.8 million) for the same period last year. Results for the first quarter 2014 included the sale of three Ablatherm and two Focal One devices.
 
·
For the three months ended March 31, 2014, total revenue for the lithotripsy division was EUR 4.5 million (USD 6.1 million), in line with EUR 4.5 million (USD 6.0 million), during the year ago period. During the first quarter 2014, the Company recorded sales of nine lithotripsy machines, comprised of seven Sonolith i-move devices, one Sonolith i-sys device, and one Sonolith Praktis, compared to a total of ten devices sold in the first quarter of 2013.
 
·
Gross profit for the first quarter 2014 was EUR 3.6 million (USD 4.9 million), compared to EUR 2.2 million (USD 2.9 million) for the year ago period. Gross profit margin was 45.9% in the first quarter 2014, compared to 37.1% in the year ago period. The change in the gross profit margin was mostly attributable to the increase in HIFU equipment sales.
 
·
Operating expenses were EUR 3.0 million (USD 4.1 million) for the first quarter 2014, compared to EUR 3.4 million (USD 4.5 million) for the same period of 2013. As a result of our increased device sales during the quarter, operating profit was EUR 558,000 (USD 765,000) for the first quarter of 2014, compared to an operating loss of EUR 1.2 million (USD 1.6 million) in the first quarter of 2013. Most noticeably, this is the first time the Company reported two sequential quarters with positive operating income.
 
·
Net income for the first quarter of 2014 was EUR 840,000 (USD 1.2 million), or EUR 0.04 per diluted share, as compared to net loss for the first quarter of 2013 of EUR 3.9 million (USD 5.1 million), or EUR 0.21 per diluted share.
 
·
At March 31, 2014, cash and cash equivalents, including short-term treasury investments, were EUR 6.4 million (USD 8.9 million). The EUR 1.2 million cash utilization in the first quarter was attributed to increased receivables related to increased sales in the first quarter to be collected over the second and third quarters.
 
 
2

 
EDAP TMS S.A.
 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
 
(Amounts in thousands of Euros and U.S. Dollars, except per share data)
 
                         
   
Three Months Ended:
   
Three Months Ended:
 
   
March 31,
   
March 31,
   
March 31,
   
March 31,
 
   
2014
   
2013
   
2014
   
2013
 
   
Euros
   
Euros
   
$US
   
$US
 
Sales of goods
    5,414       3,693       7,415       4,860  
Net Sales of RPP and Leases
    998       933       1,367       1,228  
Sales of spare parts and Services
    1,349       1,301       1,848       1,712  
TOTAL NET SALES
    7,762       5,927       10,630       7,800  
Other revenues
    3       (0 )     4       (0 )
TOTAL REVENUES
    7,765       5,927       10,634       7,800  
Cost of goods
    (2,815 )     (2,243 )     (3,855 )     (2,951 )
Cost of RPP and Leases
    (505 )     (523 )     (692 )     (688 )
Cost of spare parts & services
    (881 )     (964 )     (1,206 )     (1,268 )
Cost of sales
    (4,201 )     (3,729 )     (5,753 )     (4,908 )
GROSS PROFIT
    3,564       2,198       4,881       2,892  
Research & development expenses
    (686 )     (932 )     (939 )     (1,227 )
Marketing & Sales expenses
    (1,441 )     (1,534 )     (1,973 )     (2,019 )
G & A expenses
    (879 )     (922 )     (1,204 )     (1,213 )
Total operating expenses
    (3,006 )     (3,389 )     (4,116 )     (4,459 )
OPERATING PROFIT (LOSS)
    558       (1,191 )     765       (1,567 )
Interest (expense) income, net
    259       (2,429 )     355       (3,197 )
Currency exchange gains (loss), net
    55       (212 )     76       (279 )
Other income (loss), net
    (3 )     (2 )     (4 )     (2 )
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST
    870       (3,833 )     1,192       (5,045 )
Income tax (expense) credit
    (30 )     (50 )     (41 )     (65 )
NET INCOME (LOSS)
    840       (3,883 )     1,151       (5,110 )
                                 
 
 
3

 
Earning per share – Basic
    0.04       (0.21 )     0.05       (0.27 )
Average number of shares used in computation of EPS
    21,789,670       18,716,013       21,789,670       18,716,013  
Earning per share – Diluted
    0.04       (0.21 )     0.05       (0.27 )
Average number of shares used in computation of EPS for positive net income
    23,951,832       21,155,488       23,951,832       21,155,488  
                                 
NOTE: Translated for convenience of the reader to U.S. dollars at the 2014 average three months noon buying rate of 1 Euro = 1.3695 USD, and 2013 average three months noon buying rate of 1 Euro = 1.3160 USD.
 
 
 

 
 
4

 
EDAP TMS S.A.
 
CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (UNAUDITED)
 
(Amounts in thousands of Euros and U.S. Dollars)
 
                         
   
Mar. 31,
   
Dec. 31,
   
Mar. 31,
   
Dec. 31,
 
   
2014
   
2013
   
2014
   
2013
 
   
Euros
   
Euros
   
$US
   
$US
 
Cash, cash equivalents and short term investments 
    6,443       7,681       8,877       10,584  
Total current assets
    22,951       22,171       31,622       30,551  
Total current liabilities
    12,117       11,589       16,695       15,969  
Shareholders' Equity 
    10,160       9,284       13,999       12,794  
                                 
NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.3778 USD, on March 31, 2014 and at the noon buying rate of 1 Euro = 1.3780 USD, on December 31, 2013.
 
 
 
 
5

 
 
EDAP TMS S.A.
 
CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
 
THREE MONTHS ENDED MARCH 31, 2014
 
(Amounts in thousands of Euros)
 
                                         
   
HIFU
Division
         
UDS
Division
       
FDA
Trials
Corporate
 
Total After
Consolidation
       
                                         
Sales of goods
    2,491             2,923                 5,414        
Sales of RPPs & Leases
    550             448                 998        
Sales of spare parts & services
    245             1,104                 1,349        
TOTAL NET SALES
    3,287             4,475                 7,762        
                                               
Other revenues
    3             --                 3        
                                               
TOTAL REVENUES
    3,290             4,475                 7,765        
                                               
GROSS PROFIT
    1,948       59 %     1,617       36 %         3,564       46 %
                                                     
Research & Development
    (307 )             (222 )        
(157)
      (686 )        
Total SG&A plus depreciation
    (582 )             (1,392 )          
(346)
    (2,320 )        
                                                     
OPERATING PROFIT (LOSS)
    1,058               3          
(157)
(346)
    558          
 
 
6

 
4.  Press Release dated April 21, 2014
 
EDAP Announces Reimbursement of HIFU Treatment for Prostate Cancer by France's Ministry of Health
 
EDAP TMS SA announced the reimbursement of prostate cancer treatment procedures using High Intensity Focused Ultrasound (“HIFU”) by the French health authorities. The French Minister of Social Affairs and Health outlined the acceptance of HIFU treatment for prostate cancer for reimbursement during a visit to the Company's headquarters on April 18, 2014. Such reimbursement is part of an innovative process to further validate breakthrough therapies and to accelerate reimbursement process based on clinical trials and data registries.
 
***
 
Forward-Looking Statements
 
In addition to historical information, press releases may contain forward-looking statements.. 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 uncertainties of the U.S. FDA approval process, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device. Factors that may cause such a difference also may 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 20-F. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.
 
Additional Information
 
EDAP has filed a registration statement (including a prospectus) with the SEC for the offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement and other documents EDAP has filed with the SEC for more complete information about it and this offering. You may get these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov. Alternatively, EDAP will arrange to send you the prospectus after filing if you request it by calling +1-212-356-0500.
 
 
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