EDAP TMS S.A.
EDAP TMS SA (Form: 6-K, Received: 04/03/2017 16:11:45)

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

 

April 3, 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: April 3, 2017
EDAP TMS S.A.

 

 

 

/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER

 

 

Exhibit 99.1

 

 

EDAP Achieves 63% Growth in HIFU Revenue in 2016

 

2016 Highlights

 

Total revenue for 2016 reached double-digit growth, increasing to EUR 35.6 million (USD 39.3 million)
Gross margin for 2016 expanded to 46.1% compared to 42.8% during the prior year period
Strong cash position of EUR 22.0 million (USD 23.2 million) as of December 31, 2016

 

LYON, France, April 3, 2017 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today financial results for the fourth quarter and twelve months ended December 31, 2016, and provided an update on strategic and operational accomplishments. 

 

Marc Oczachowski, EDAP's Chief Executive Officer, stated, "I am thrilled with the performance of our team in 2016. We successfully grew our HIFU revenue more than 63% to EUR 13.8 million, resulting in total 2016 revenue of EUR 35.6 million. EDAP strengthened its HIFU presence in the U.S. during 2016, adding key academic centers to its HIFU user base while significantly expanding operations globally. Ablatherm® and the Focal One® continued to enjoy a warm reception from the global medical community supported by strong, positive clinical data. Notably, Focal One's innovative prostate treatment received clear recognition from the global scientific community when awarded the prestigious Prix Galien Award this past December."

 

Mr. Oczachowski concluded, "2016 was rich in positive events; please join us Tuesday, April 4, 2017, for a detailed discussion of our continued success and expansion."

 

Fourth Quarter 2016 Results

 

Total revenue for the fourth quarter 2016 was EUR 10.7 million (USD 11.4 million), a 9.3% decreased compared to EUR 11.8 million (USD 12.8 million) for the fourth quarter of 2015.

 

Total revenue in the HIFU business for the fourth quarter was EUR 4.6 million (USD 4.9 million), a 38.3% increase compared to EUR 3.3 million (USD 3.6 million) for the fourth quarter of 2015. 

 

For the three months ended December 31, 2016, total revenue for the Lithotripsy division was EUR 6.1 (USD 6.5 million), a 27.9% decreased compared to EUR 8.5 million (USD 9.2 million) during the year-ago period.

 

Gross profit for the fourth quarter 2016 was EUR 5.2 million (USD 5.6 million), compared to EUR 5.3 million (USD 5.7 million) for the year-ago period. Gross profit margin on net sales was 48.8% in the fourth quarter of 2016, compared to 45.0% in the year-ago period.

 

Operating expenses were EUR 4.9 million (USD 5.2 million) for the fourth quarter of 2016, compared to EUR 3.7 million (USD 4.0 million) for the same period in 2015.

 

Operating profit for the fourth quarter 2016 was EUR 0.3 million (USD 0.4 million), compared to EUR 1.6 million (USD 1.7 million) in the fourth quarter of 2015.

 

Net loss for the fourth quarter 2016 was EUR 1.3 (USD 1.4 million), or a loss of EUR 0.04 per diluted share, as compared to net income of EUR 5.1 million (USD 5.5 million), or EUR 0.18 per diluted share in the year-ago period.  Net income in the fourth quarter of 2016 included non-cash interest expense of EUR 0.4 million (USD 0.5 million) to adjust the accounting fair value of the outstanding warrants.

 

 
 

 

Year Ended 2016 Results

 

Total revenue for 2016 was EUR 35.6 million (USD 39.3 million), an increase of 10.4% compared to EUR 32.3 million (USD 35.6) for the year ended December 31, 2015.

 

Total revenue in the HIFU business for 2016 was EUR 13.8 million (USD 15.2 million), an increase of 63.0% compared to EUR 8.5 million (USD 9.4 million) for the year ended December 31, 2015.

 

Total revenue in the Lithotripsy business for 2016 was EUR 21.8 million (USD 24.0 million), a decrease of 8.3% compared to EUR 23.8 million (USD 26.2 million) for the year ended December 31, 2015.

 

Gross profit for 2016 was EUR 16.4 million (USD 18.1 million), with gross profit margin on net sales of 46.1%, compared to 42.8% during the prior year period.

 

The Company recorded operating profit for 2016 of EUR 0.4 million (USD 0.4 million), compared to an operating profit of EUR 0.5 million (USD 0.5 million) during the prior year period.

 

Full-year net income was EUR 3.8 million (USD 4.2 million), or EUR 0.13 per diluted share, as compared to a net loss of EUR 1.7 million (USD 1.8 million), or a loss of EUR 0.07 per diluted share in 2015. Full-year net income included non-cash interest income of EUR 4.0 million to adjust the accounting fair value of the outstanding warrants.

 

At December 31, 2016, cash and cash equivalents were EUR 22.0 million (USD 23.2 million).

 

Conference Call

 

An accompanying conference call will be conducted by Marc Oczachowski, Chief Executive Officer, and Francois Dietsch, Chief Financial Officer, to go over the results. The call will be held at 8:30 AM ET, on Tuesday, April 4, 2017. Please refer to the information below for conference call dial-in information and webcast registration.

 

Conference Date: Tuesday, April 4, 2017 8:30 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: EDAP-TMS Fourth Quarter and Full Year 2016 Results 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. 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. The Company also 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-planet.com.

 

 
 

 

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.

 

 

 

 

 

 

 
 

 

EDAP TMS S.A.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

 

    Three Months Ended:   Three Months Ended:
    December 31,   December 31,   December 31,   December 31,
    2016   2015   2016   2015
    Euros   Euros   $US   $US
Sales of medical equipment     7,566       9,049       8,093       9,792  
Net Sales of RPP and Leases     1,231       1,151       1,317       1,245  
Sales of spare parts, supplies and Services     1,875       1,560       2,006       1,688  
TOTAL NET SALES     10,672       11,760       11,417       12,726  
Other revenues     22       32       24       35  
TOTAL REVENUES     10,695       11,792       11,441       12,760  
Cost of sales     (5,492 )     (6,495 )     (5,875 )     (7,029 )
GROSS PROFIT     5,203       5,297       5,566       5,732  
Research & development expenses     (1,135 )     (565 )     (1,214 )     (612 )
S, G & A expenses     (3,733 )     (3,147 )     (3,994 )     (3,406 )
Total operating expenses     (4,868 )     (3,713 )     (5,208 )     (4,018 )
OPERATING PROFIT (LOSS)     335       1,584       358       1,714  
Interest (expense) income, net     (444 )     3,710       (475 )     4,015  
Currency exchange gains (loss), net     (698 )     476       (746 )     516  
Other income (loss), net     -       5       -       5  
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST     (807 )     5,775       (863 )     6,249  
Income tax (expense) credit     (471 )     (659 )     (504 )     (713 )
NET INCOME (LOSS)     (1,278 )     5,116       (1,367 )     5,536  
Earning per share – Basic     (0.04 )     0.20       (0.05 )     0.22  
Average number of shares used in computation of EPS     28,727,616       25,254,618       28,727,616       25,254,618  
Earning per share – Diluted     (0.04 )     0.18       (0.05 )     0.19  
Average number of shares used in computation of EPS for positive net income     28,727,616       28,846,270       28,727,616       28,846,270  

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2016 average three months’ noon buying rate of 1 Euro = 1.0697 USD, and 2015 average three months noon buying rate of 1 Euro = 1.0821 USD.

 

 
 

 

EDAP TMS S.A.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

 

    Twelve Months Ended:   Twelve Months Ended:
    December 31,   December 31,   December 31,   December 31,
    2016   2015   2016   2015
    Euros   Euros   $US   $US
Sales of medical equipment     24,045       21,906       26,520       24,168  
Net Sales of RPP and Leases     4,906       4,408       5,411       4,864  
Sales of spare parts, supplies and Services     6,628       5,904       7,310       6,513  
TOTAL NET SALES     35,579       32,218       39,240       35,545  
Other revenues     32       35       35       39  
TOTAL REVENUES     35,611       32,253       39,276       35,584  
Cost of sales     (19,200 )     (18,468 )     (21,176 )     (20,375 )
GROSS PROFIT     16,411       13,785       18,100       15,209  
Research & development expenses     (3,868 )     (2,690 )     (4,266 )     (2,968 )
S, G & A expenses     (12,152 )     (10,608 )     (13,402 )     (11,703 )
Total operating expenses     (16,019 )     (13,298 )     (17,668 )     (14,671 )
OPERATING PROFIT (LOSS)     392       488       432       538  
Interest (expense) income, net     3,949       (2,094 )     4,355       (2,310 )
Currency exchange gains (loss), net     103       699       114       771  
Other income (loss), net     -       -       -       -  
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST     4,444       (907 )     4,901       (1,001 )
Income tax (expense) credit     (602 )     (759 )     (663 )     (838 )
NET INCOME (LOSS)     3,842       (1,667 )     4,238       (1,839 )
Earning per share – Basic     0.14       (0.07 )     0.15       (0.07 )
Average number of shares used in computation of EPS     27,823,313       25,021,966       27,823,313       25,021,966  
Earning per share – Diluted     0.13       (0.07 )     0.14       (0.07 )
Average number of shares used in computation of EPS for positive net income     29,365,583       25,021,966       29,365,583       25,021,966  

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2016 average twelve months noon buying rate of 1 Euro = 1.1029 USD, and 2015 average twelve months noon buying rate of 1 Euro = 1.1033 USD.

 

 
 

 

EDAP TMS S.A.

CONSOLIDATED BALANCE SHEETS HIGHLIGHTS

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

 

    Dec.  31,   Sept.  30,   Dec.  31,   Sept.  30,
    2016   2016   2016   2016
    Euros   Euros   $US   $US
                 
Cash, cash equivalents and short term investments     21,989       18,837       23,202       21,170  
Total current assets     40,514       40,694       42,750       45,734  
Total current liabilities     15,010       14,547       15,838       16,349  
Shareholders’ Equity     24,451       25,739       25,800       28,926  

 

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.0552 USD, on December 31, 2016 and at the noon buying rate of 1 Euro = 1.1238 USD, on September 30, 2016.

 

 

 

EDAP TMS S.A.

CONDENSED STATEMENTS OF OPERATIONS BY DIVISION

TWELVE MONTHS ENDED DECEMBER 31, 2016

(Amounts in thousands of Euros)

 

    HIFU Division   UDS Division   Corporate   Total After
Consolidation
 
                   
Sales of goods     9,382       14,664               24,045    
Sales of RPPs & Leases     3,547       1,359               4,906    
Sales of spare parts & services     862       5,766               6,628    
TOTAL NET SALES     13,791       21,789               35,579    
                                   
Other revenues     28       4               32    
                                   
TOTAL REVENUES     13,819       21,792               35,611    
GROSS PROFIT     8,109    58.7%   8,302    38.1%           16,411    46.1%
(% of Total Revenues)                                  
                                   
Research & Development     (2,452 )     (1,416 )             (3,868 )  
Total SG&A plus depreciation     (4,692 )     (6,145 )     (1,315 )     (12,152 )  
                                   
OPERATING PROFIT (LOSS)     964       742       ( 1,315     392