EDAP TMS SA : EDAP Reports 2018 First Quarter Results

Planet edap Inc.
May 14,2018

EDAP TMS SA : EDAP Reports 2018 First Quarter Results

  • 2018 Q1 total revenue records a 6% increase year-over-year
  • Focal One Final Additional Information submitted to FDA early May
  • EDAP to attend American Urological Association congress in San Francisco, May 18-21, 2018

LYON, France, May 14, 2018 -- EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in therapeutic ultrasound, announced today financial results for the first quarter of 2018, and provided an update on strategic and operational developments. 

Marc Oczachowski, EDAP's Chief Executive Officer, said: "We are pleased with the return to growth in the first quarter, a trend we expect to sustain, and we look forward to feedback from the FDA following our submission for Focal One to the Agency. We also look forward to engaging with our customers and key opinion leaders at the upcoming annual meeting of the American Urological Association later this month where we will showcase the important benefits of Focal One for soft tissue ablation of the prostate."

First Quarter 2018 Results

Total revenue for the first quarter 2018 was EUR 9.2 million (USD 11.3 million), a 6% increase compared to EUR 8.7 million (USD 9.3 million) for the first quarter of 2017.

Total revenue in the HIFU business for the first quarter 2018 was EUR 2.4 million (USD 3.0 million), a 5% increase compared to EUR 2.3 million (USD 2.5 million) for the first quarter of 2017. 

For the three months ended March 31, 2018, total revenue for the Lithotripsy division was EUR 6.7 (USD 8.3 million), a 6% increase compared to EUR 6.4 million (USD 6.8 million) during the year-ago period.

Gross profit for the first quarter 2018 was EUR 4.0 million (USD 4.9 million), compared to EUR 3.6 million (USD 3.8 million) for the year-ago period. Gross profit margin on net sales was 43.8% in the first quarter of 2018, compared to 41.1% in the year-ago period.

Operating expenses were EUR 4.4 million (USD 5.4 million) for the first quarter of 2018, compared to EUR 4.0 million (USD 4.3 million) for the same period in 2017.

Operating loss for the first quarter 2018 was EUR 0.4 million (USD 0.5 million), compared to an operating loss of EUR 0.4 million (USD 0.4 million) in the first quarter of 2017.

Net income for the first quarter 2018 was EUR 89 thousand (USD 109 thousand), or earnings of EUR 0.00 per diluted share, as compared to a net income of EUR 1.7 million (USD 1.8 million), or earnings of EUR 0.06 per diluted share in the year-ago period. Net income in the first quarter of 2018 included non-cash interest expense of EUR 647 thousand (USD 797 thousand) to adjust the accounting fair value of the outstanding warrants.

Conference Call

An accompanying conference call will be conducted by Philippe Chauveau, Chairman of the Board; Marc Oczachowski, Chief Executive Officer; and François Dietsch, Chief Financial Officer, to review the results. The call will be held at 8:30 AM ET, on Tuesday May 15, 2018. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Tuesday, May 15, 2018 @ 8:30am Eastern Time
Domestic:                                             866-548-4713
International                                       323-794-2093
Passcode:                                             9225280
Webcast:                                              http://public.viavid.com/index.php?id=129164

Replays, Available through May 29, 2018:
Domestic:                                             844-512-2921
International:                                      412-317-6671
Replay PIN:                                          9225280

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

A recognized leader in the global therapeutic ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for urology using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® (currently pending FDA clearance) in 2013 as the answer to all requirements for ideal prostate tissue ablation as a complement to the existing FDA cleared Ablatherm® Robotic HIFU and Ablatherm® Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively utilizes the latest generation of shock wave source in its Sonolith® range of ESWL systems. For more information on the Company, please visit http://www.edap-tms.com, and us.hifu-prostate.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.

Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com

Investor Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com


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

                                                                                                    Three Months Ended:                                   Three Months Ended:

  March 31,
2018
Euros
  March 31,
2017
Euros
  March 31, 
2018
$US
  March 31, 
2017
$US
Sales of medical equipment

Net Sales of RPP and Leases
5,751

1,210
  5,512

1,295
  7,085

1,491
  5,899

1,386
Sales of spare parts, supplies and
Services
 

2,197
   

1,842
   

2,707
   

1,972
TOTAL NET SALES 9,158   8,648   11,283   9,257
Other revenues -   26   -   28
TOTAL REVENUES 9,158   8,675   11,283   9,285
Cost of sales (5,147)   (5,123)   (6,341)   (5,483)
GROSS PROFIT 4,011   3,551   4,942   3,801
Research & development expenses (1,000)   (896)   (1,232)   (959)
S, G & A expenses (3,413)   (3,075)   (4,205)   (3,291)
Total operating expenses (4.413)   (3,971)   (5,437)   (4,250)
OPERATING PROFIT (LOSS) (402)   (419)   (495)   (449)
Interest (expense) income, net 639   1,983   787   2,123
Currency exchange gains (loss), net (15)   175   (18)   188
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST 223   1,739   274   1,861
Income tax (expense) credit (134)   (58)   (165)   (62)
NET INCOME (LOSS) 

 

 

 
89   1,681   109

 
  1,799
Earning per share - Basic 0.00   0.06   0.00   0.06
Average number of shares used in  computation of EPS 28,997,866   28,839,099   28,997,866   28,839,099
Earning per share - Diluted 0.00   0.06   0.00   0.06
Average number of shares used in  computation of EPS for positive net income

 
29,345,366   30,213,544   29,345,366   30,213,544

NOTE:  Translated for convenience of the reader to U.S. dollars at the 2018 average three months' noon buying rate of 1 Euro = 1.2320 USD, and 2017 average three months noon buying rate of 1 Euro = 1.0703 USD.


EDAP TMS S.A.
UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS
(Amounts in thousands of Euros and U.S. Dollars)

    Mar.  31,
  2018
  Euros
  Dec.  31,
2017
Euros
  Mar.  31,
2018
$US
    Dec.  31,
2017
$US
 

                                                               

Cash, cash equivalents and short  term investments 18,142     20,004 22,351 24,049    
Total current assets 37,734     39,558 46,487 47,557    
Total current liabilities 13,843     16,134 17,054 19,397    
Shareholders' Equity 25,439     25,143 31,340 30,227    

NOTE:  Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.2320 USD, on March 31, 2018 and at the noon buying rate of 1 Euro = 1.2022 USD, on December 31, 2017.

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
THREE MONTHS ENDED MARCH 31, 2018
(Amounts in thousands of Euros)

     

HIFU Division
   

UDS Division
     

Corporate
  Total After Consolidation  
 

Sales of goods
 

1,109
   

4,642
         

5,751
 
Sales of RPPs & Leases 861   349         1,210  
Sales of spare parts & services 467   1,730         2,197  
TOTAL NET SALES

 
2,437   6,721         9,158  
Other revenues

 
-   -         -  
TOTAL REVENUES 2,437   6,721         9,158  
GROSS PROFIT
(% of Total Revenues)
1,310 53.7% 2,702 40.2%       4,011 43.8%
 

Research & Development
 

(611)
  (389)         (1,000)  
Total SG&A plus depreciation (1,381)   (1,696)     (336)   (3,413)  
 

OPERATING PROFIT (LOSS)
 

(682)
   

616
     

(336)
   

(402)
 

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Source: EDAP TMS S.A.