EDAP TMS S.A.
EDAP TMS SA (Form: 6-K, Received: 11/15/2017 16:35:19)

 

 

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

 

November 15, 2017

 

Commission File Number: 0-29374

 

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

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of 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): ____

 

 

 


 

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: November 15, 2017
EDAP TMS S.A.

 

 

 

/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER

 

 

 

Exhibit 99.1

 

EDAP TMS Reports Third Quarter 2017 Results

 

· EDAP's HIFU patient treatment revenues grew 29% compared to third quarter 2016.
· EDAP received FDA clearance for its Ablatherm Fusion ®  late in the quarter.
· EDAP's cash position remains strong at US $21.3 million on September 30, 2017

 

LYON, France, November 15, 2017 -- EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, today announced financial results for the third quarter ended September 30, 2017 and an update on strategic and operational accomplishments.

 

Marc Oczachowski, EDAP’s Chief Executive Officer, stated, "Our team has executed another successful quarter. Physicians and patients are clearly responding to the advantages of HIFU for prostate cancer as evidenced by our 29% growth in treatment driven revenues compared to the third quarter of 2016."

 

"EDAP received clearance for the Ablatherm Fusion late in the quarter. Our current Ablatherm users are initiating the upgrade process, excited for the increased accuracy provided by Ablatherm Fusion’s proprietary imaging software. In the meantime, we continue to work with the FDA for the clearance of Focal One ® .”

 

Third Quarter 2017 Results

 

Total revenue for the third quarter of 2017 was EUR 7.1 million (USD 8.4 million), compared to EUR 8.0 million (USD 8.9 million) for the third quarter of 2016.

 

For the three months ended September 30, 2017, total revenue for the Lithotripsy division was EUR 5.3 million (USD 6.3 million), compared to EUR 5.4 million (USD 6.1 million) during the year-ago period. During the third quarter of 2017, EDAP sold 6 lithotripsy devices compared to 11 lithotripsy devices sold during the third quarter of 2016.

 

Total revenue in the HIFU business for the third quarter was EUR 1.8 million (USD 2.2 million) compared to EUR 2.5 million (USD 2.8 million) for the third quarter of 2016. During the third quarter of 2017, EDAP sold no HIFU devices compared to 2 Focal One devices during the third quarter of 2016.

 

Gross profit for the third quarter of 2017 was EUR 2.8 million (USD 3.3 million), compared to EUR 3.5 million (USD 3.9 million) for the year-ago period. Gross profit margin on net sales was 39.4% in the third quarter of 2017, compared to 43.2% in the prior year period, primarily due to a lower revenue.

 

Operating expenses for the third quarter of 2017 totaled EUR 3.8 million (USD 4.5 million) for the third quarter of 2017, compared to EUR 3.8 million (USD 4.2 million) for the same period in 2016.

 

Operating loss for the third quarter of 2017 was EUR 1.0 million (USD 1.2 million), compared to an operating loss of EUR 0.3 million (USD 0.4 million) in the third quarter of 2016. ‘

 

Net loss for the third quarter of 2017 was EUR 0.5 million (USD 0.6 million), or loss of EUR 0.02 per diluted share, as compared to net income of EUR 1.3 million (USD 1.4 million), or earnings of EUR 0.04 per diluted share in the year-ago period. Net loss during the third quarter of 2017 included a non-cash interest income of EUR 0.8 million to adjust the accounting fair value of the outstanding warrants

 

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First Nine Months 2017 Results

 

Total revenue for the first nine months of 2017 was EUR 25.1 million (USD 28.2 million) up 1% compared to 24.9 million (USD 27.8 million) during the first nine months of 2016.

 

For the nine months ended September 30, 2017, total revenue for the Lithotripsy division was EUR 18.1 million (USD 20.3 million), a growth of 15% compared to EUR 15.7 million (USD 17.5 million). During the first nine months of 2017 EDAP sold 21 Lithotripsy devices compared to 27 Lithotripsy devices during the year ago period.

 

HIFU revenue for the nine months ended September 30, 2017 was EUR 7.1 (USD 7.9 million) compared to EUR 9.2 million (USD 10.3 million) during the first nine months of 2016. During the first nine months of 2017, EDAP sold 4 HIFU devices, compared to 10 HIFU devices sold during the first nine months of 2016.

 

Gross profit for the first nine months of 2017 was EUR 10.4 million (USD 11.7 million) and gross profit margin on net sales was 41.4% compared to EUR 11.2 million (USD 12.5 million) and gross profit margin of 45.0% during the first nine months of 2016.

 

Operating loss for the first nine months of 2017 was EUR 1.8 million (USD 2.1 million) compared to an operating profit of EUR 0.1 million (USD 0.1 million) during the same period of 2016.

 

Net loss for the first nine months of 2017 was EUR 0.6 million (USD 0.7 million), or loss of EUR 0.02 per share (USD 0.02), compared to net income of EUR 5.1 million (USD 5.7 million), or earnings of EUR 0.18 (USD 0.20) per share during the first nine months of 2016. Net loss for the first nine months of 2017 included non-cash interest income of EUR 2.2 million to adjust the accounting fair value of the outstanding warrants.

 

As of September 30, 2017, cash and cash equivalents, including short-term treasury investments, were EUR 18.0 million (USD 21.3 million).

 

Conference Call

 

An accompanying conference call will be conducted by Philippe Chauveau, Chairman of the Board, Marc Oczachowski, Chief Executive Officer; and Francois Dietsch, Chief Financial Officer, to review the results. The call will be held at 8:30 AM ET, on Thursday, November 16, 2017. Please refer to the information below for conference call dial-in information and webcast registration.

 

Conference Date: Thursday, November 16, 2017, 8:30 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: EDAP-TMS Third Quarter 2017 Results Conference Call
Webcast Registration: Click Here

 

Following the live call, a replay will be available on the Company's website, www.edap-tms.com under "Investors Information."

 

About EDAP TMS SA

 

EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA. Ablatherm Fusion, next generation of Ablatherm device is now FDA cleared. The Company also markets an innovative robot-assisted HIFU device, the Focal One®, dedicated to focal therapy of prostate cancer. Focal One® is CE marked but is not FDA approved. In addition, the Company develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith® lithotripters' range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-prostate.com.

 

 

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Forward-Looking Statements
In addition to historical information, this press release 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 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.

 

Company Contact

 

Blandine Confort

Investor Relations / Legal Affairs

EDAP TMS SA

+33 4 72 15 31 72

bconfort@edap-tms.com

 

Investors

Rich Cockrell

CG Capital

877.889.1972

rich@cg.capital

 

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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 :
    September 30,
2017
Euros
  September 30,
2016
Euros
  September 30,
2017
$US
  September 30,
2016
$US
Net sales of goods
    3,889       5,218       4,606       5,836  
Net sales of RPP and Leases     1,277       1,098       1,512       1,228  
Net sales of spare parts and Services     1,955       1,674       2,316       1,873  
TOTAL NET SALES     7,121       7,990       8,434       8,936  
Other revenues     4       2       4       2  
TOTAL REVENUES     7,124       7,992       8,438       8,938  
Cost of sales     (4,317 )     (4,537 )     (5,114 )     (5,075 )
GROSS PROFIT     2,807       3,454       3,324       3,864  
Research & development expenses     (918 )     (1,032 )     (1,087 )     (1,154 )
S, G & A expenses     (2,889 )     (2,754 )     (3,422 )     (3,080 )
Total operating expenses     (3,807 )     (3,786 )     (4,510 )     (4,234 )
OPERATING PROFIT (LOSS)     (1,001 )     (332 )     (1,185 )     (371 )
Interest (expense) income, net     821       1,502       972       1,680  
Currency exchange gains (loss), net     (325 )     130       (385 )     145  
Other income (loss), net     -       -       -       -  
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST     (504 )     1,301       (597 )     1,455  
Income tax (expense) credit     (21 )     (40 )     (25 )     (44 )
NET INCOME (LOSS)
    (525 )     1,261       (622 )     1,411  
Basic income (loss) per share     (0.02 )     0.04       (0.02 )     0.05  
Basic weighted average shares outstanding     28,997,866       28,727,616       28,997,866       28,727,616  
Diluted income (loss) per share     (0.02 )     0.04       (0.02 )     0.05  
Diluted weighted average shares outstanding     28,997,866       30,251,966       28,997,866       30,251,966  

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2017 average three months’ noon buying rate of 1 Euro = 1.1844USD, and 2016 average three months’ noon buying rate of 1 Euro = 1.1184 USD.

 

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EDAP TMS S.A.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

(Amounts in thousands of Euros and U.S. Dollars, except per share data)

 

    Nine Months Ended:   Nine Months Ended:
    September 30,
2017
Euros
  September 30,
2016
Euros
  September 30,
2017
$US
  September 30,
2016
$US
Net sales of goods
    15,367       16,480       17,276       18,356  
Net sales of RPP and leases     3,876       3,675       4,357       4,094  
Net sales of spare parts and Services     5,834       4,752       6,559       5,293  
TOTAL NET SALES     25,076       24,907       28,192       27,742  
Other revenues     43       10       48       11  
TOTAL REVENUES     25,119       24,917       28,240       27,753  
Cost of sales     (14,745 )     (13,709 )     (16,576 )     (15,269 )
GROSS PROFIT     10,375       11,208       11,663       12,484  
Research & development expenses     (2,783 )     (2,733 )     (3,129 )     (3,044 )
S, G & A expenses     (9,441 )     (8,418 )     (10,614 )     (9,376 )
Total operating expenses     (12,224 )     (11,151 )     (13,742 )     (12,420 )
OPERATING PROFIT (LOSS)     (1,849 )     57       (2,079 )     63  
Interest (expense) income, net     2,229       4,393       2,506       4,893  
Currency exchange gains (loss), net     (775 )     801       (871 )     892  
Other income (loss), net     -       -       -       (1 )
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST     (394 )     5,250       (443 )     5,848  
Income tax (expense) credit     (196 )     (130 )     (220 )     (145 )
NET INCOME (LOSS)
    (590 )     5,120       (663 )     5,703  
Basic income (loss) per share     (0.02 )     0.19       (0.02 )     0.21  
Basic weighted average shares outstanding     28,947,947       27,497,107       28,947,947       27,497,107  
Diluted income (loss) per share     (0.02 )     0.18       (0.02 )     0.20  
Diluted weighted average shares outstanding     28,947,947       29,045,939       28,947,947       29,045,939  

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2017 average six months’ noon buying rate of 1 Euro = 1.1242USD, and 2016 average six months’ noon buying rate of 1 Euro = 1. 1138 USD.

 

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EDAP TMS S.A.

CONSOLIDATED BALANCE SHEETS HIGHLIGHTS

(Amounts in thousands of Euros and U.S. Dollars)

 

     

Sept. 30,

2017

Euros

     

June 30,

2017

Euros

     

Sept. 30,

2017

$US

     

June 30,

2017

$US

 
Cash, cash equivalents and short term investments     18,036       18,554       21,306       21,173  
Total current assets     37,172       39,583       43,912       45,171  
Total current liabilities     12,676       13,372       14,975       15,260  
Shareholders’ Equity     24,947       25,383       29,471       28,966  

 

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1813 USD, on September 30, 2017 and at the noon buying rate of 1 Euro = 1.1412 USD, on June 30, 2017.

 

EDAP TMS S.A.

CONDENSED STATEMENTS OF OPERATIONS BY DIVISION

NINE MONTHS ENDED SEPTEMBER 30, 2017

(Amounts in thousands of Euros)

 

      HIFU Division               UDS Division               Corporate       Total After Consolidation    
 Sales of goods     3,109               12,258                       15,367    
Sales of RPPs & leases     2,891               984                       3,876    
Sales of spare parts & services     1,050               4,784                       5,834    
TOTAL NET SALES
    7,050               18,026                       25,076    
Other revenues
    8               35                       43    
TOTAL REVENUES     7,058               18,062                       25,119    
GROSS PROFIT
(% of Total Revenues)
    3,621       51%     6,754       37%             10,375   41%
                                                   
 Research & Development     (1,814 )             (969 )                     (2,783 )  
Total SG&A plus depreciation     (3,627 )             (4,711 )             (1,103 )     (9,441 )  
 OPERATING PROFIT (LOSS)     (1,820 )             1,074               (1,103 )     (1,849 )  

 

 

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