EDAP Reports Fourth Quarter 2012 and Full Year Results

EDAP Reports Fourth Quarter 2012 and Full Year Results

Highlights


  *Record fourth quarter 2012 revenue of EUR 9.5 million (USD 12.3 million),
    up 25.3% year-over-year
  *Record full year revenue of EUR 26.1 million (USD 33.6 million), up 16.9%
    year-over-year
  *Record lithotripsy sales in 2012
  *PMA for Ablatherm®-HIFU for treatment of low risk, localized prostate
    cancer accepted by the FDA for filing on March 26, 2013

LYON, France, April 2, 2013 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the
global leader in therapeutic ultrasound, announced today financial results for
the fourth quarter and year ended December 31, 2012, and provided an update on
recent strategic developments.

Marc Oczachowski, EDAP's Chief Executive Officer, stated, "We are very pleased
with our record revenues in the fourth quarter, and for the full year
2012.Our sales growth can be attributed to the robust sales of our innovative
Sonolith lithotripters around the globe.Customers continue to respond to our
innovative products and improving offerings.We continue to aggressively
pursue market penetration, and strengthen our sales operations across key
markets, including Europe, Asia, and the U.S."

Mr. Oczachowski continued, "Our PMA application for Ablatherm-HIFU is steadily
moving forward through the U.S. FDA review process.Last week we received
notification that our PMA had been accepted for Filing Review, less than two
months after we submitted the complete application to the FDA. With this
significant milestone completed, we have now entered the substantive review
phase, and we are looking forward to a continuing dialog with the agency as
the review process advances."

Recent Developments

In March 2013, the U.S. Food and Drug Administration (FDA) provided a positive
Filing Review Notification for the EDAP's Pre-Market Approval (PMA)
application for its Ablatherm Integrated Imaging HIFU (High Intensity Focused
Ultrasound) device for treatment of low risk, localized prostate cancer.The
PMA was received by the FDA on February 5, 2013, and was given a filing date
of February 28, 2013.The PMA submission included data from the Company's
ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed
the two year follow-up needed to evaluate its primary endpoint in August 2012,
as well as data from the Company's extensive worldwide database of treatment
information and follow-up data from patients who have undergone HIFU therapy
for prostate cancer.

In March 2013, EDAP introduced Focal.One®, the Company's new robotic HIFU
device for focal therapy of prostate cancer at the European Association of
Urology Annual Congress in Milan, Italy. Focal.One is the first device fully
dedicated to the focal approach for prostate cancer therapy. It combines three
essential components to efficiently perform a focal treatment: (i)
state-of-the-art imaging to localize tumors with the use of magnetic resonance
imaging combined with real-time ultrasound, (ii) utmost precision of HIFU
treatment focused on identified targeted cancer areas only and (iii) immediate
feedback on treatment efficacy utilizing Contrast-Enhanced Ultrasound Imaging.

In February 2013, the Journal of Urology, the Official Journal of the American
Urological Association published results from a study in Munich on 704
patients over fifteen years. The study demonstrated high rates of both
cancer-specific survival, and freedom from salvage therapy for patients
treated with HIFU therapy. Investigators concluded that the 15 year outcome
data may warrant closing of investigational phase for HIFU.

In January 2013, the British Journal of Urology, International, published a
landmark study of over 538 patients demonstrating the safety and long-term
efficacy of EDAP's Ablatherm-HIFU for the treatment of localized prostate
cancer with ten year biochemical outcomes and follow-up extending to fourteen
years. Data from this long-term year retrospective study, the longest study of
HIFU patients to date published, confirmed benefits of the treatment.

Fourth Quarter 2012 Results

Total revenue for the fourth quarter 2012 was EUR 9.4 million (USD 12.3
million), a 25.3% year over year increase compared to EUR 7.5 million (USD
10.1 million) for the fourth quarter 2011 and a 66% sequential increase
compared to EUR 5.7 million (USD 7.1 million) for the third quarter 2012.

Total revenue for the HIFU division was EUR 2.3 million (USD 3.0 million) for
the fourth quarter 2012, compared to EUR 1.8 million (USD 2.4 million) for the
same period last year. Results for the fourth quarter 2012 reflected the sale
of three Ablatherm-HIFU devices, as compared to one device sold in the same
period last year.

For the three months ended December 31, 2012, total revenue for the
Lithotripsy division was EUR 7.1 million (USD 9.3 million), compared to EUR
5.8 million (USD 7.8 million), during the year ago period. During the fourth
quarter 2012, the Company recorded sales of 21 lithotripsy machines, comprised
of 11 Sonolith i-move devices, seven Sonolith i-sys devices and three Sonolith
Praktis devices, compared to a total of sixteen devices sold in the fourth
quarter of 2011.

Gross profit for the fourth quarter 2012 was EUR 3.9 million (USD 5.1
million), compared to EUR 2.8 million (USD 3.8 million) for the year ago
period. Gross profit margin was 41.3% in the fourth quarter 2012, compared to
37.2% in the year ago period. The change in the gross profit margin was mostly
attributed to sales volumes.

Operating expenses were EUR 3.6 million (USD 4.7 million) for the fourth
quarter 2012, compared to EUR 3.2 million (USD 4.3 million) for the same
period 2011. Operating profit was EUR 254,000 (USD 331,000) for the fourth
quarter 2012, compared to an operating loss of EUR 371,000 (USD 499,000
million) in the fourth quarter of 2011.

Net loss for the fourth quarter 2012 was EUR 1.1 million (USD 1.4 million), or
EUR 0.06 per diluted share, as compared to net loss for the fourth quarter of
2011 of EUR 579,000 (USD 779,000), or EUR 0.04 per diluted share. Net income
for the fourth quarter 2012 included a non-cash interest expense of EUR
439,000 to adjust the Company's outstanding convertible debt and warrants to
fair market value.

At December 31, 2012, cash and cash equivalents, including short-term treasury
investments, were EUR 8.1 million (USD 10.7 million). The Company's cash flow
was stable in the fourth quarter.

Full Year 2012 Results

Total revenue for the full year ended December 31, 2012 was EUR 26.1 million
(USD 33.7 million), a 16.9% growth year-over-year as compared to EUR 22.3
million (USD 31.2 million) for the full year 2011. 2012 revenue included the
sale of 52 lithotripsy devices and 4 Ablatherm-HIFU devices..

Gross profit for the full year 2012 was EUR 10.4 million (USD 13.5 million)
and operating loss was EUR 2.0 million (USD 2.6 million), compared to EUR 8.9
million (USD 12.4 million) and EUR 2.5 million (USD 3.5 million),
respectively, for the same period 2011.

Net loss for the full year 2012 was EUR 7.5 (USD 9.7 million), or EUR 0.43 per
diluted share. The full year 2012 net loss included a non-cash interest
expense of EUR 4.0 million (USD 5.1 million) to reflect the accounting fair
value impact of the January 2012 exchange offering on its convertible
debentures and related warrants, the reduction of the outstanding
non-convertible debt and fair-value adjustments of outstanding warrants. 

Conference Call

EDAP will hold a conference call today Tuesday, April 2, 2013 at 8:30 a.m. EDT
to discuss the results. The dial-in numbers are (877) 317-6789 for domestic
callers and (412) 317-6789 for international. The conference ID number for
both is 10026204. A live Webcast of the conference call will be available
online from the investor relations page of the Company's corporate Website at
www.edap-tms.com.

After the live Webcast, the call will remain available on EDAP's Website,
www.edap-tms.com, through May 2, 2013. In addition, a telephonic replay of the
call will be available until April 12, 2013. The replay dial-in numbers are
(877) 344-7529 for domestic callers and (412) 317-0088 for international
callers. Please use event passcode: 10026204. 

About EDAP TMS SA

EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound
(HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a
minimally invasive and effective treatment option 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 and commercialized in Europe as a
treatment for prostate cancer and is currently under regulatory review in the
U.S. following submission of the Pre-Market Approval Application in February
2013 after the completion ofa multi-center U.S. Phase II/III clinical trial
under an Investigational Device Exemption (IDE) granted by the FDA. The
Company also develops its HIFU technology for the potential treatment of
certain other types of tumors. EDAP TMS SA also produces and commercializes
medical equipment (the Sonolith® range) for treatment of urinary tract stones
using extra-corporeal shockwave lithotripsy (ESWL). 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 that involve risks and uncertainties. Such
statements are based on management's current expectations and are subject to a
number of uncertainties, including the uncertainties of the regulatory
process, and risks that could cause actual results to differ materially from
those described in these forward-looking statements. Factors that may cause
such a difference 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.

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:
                    December31,   December31,  December31,  December31,
                   2012           2011          2012           2011
                    Euros          Euros         $US            $US
Sales of medical    7,200          4,924         9,397          6,626
equipment
Net Sales of RPP    1,058          1,213         1,380          1,632
and Leases
Sales of spare                                               
parts, supplies and 1,121          1,394         1,463          1,877
Services
TOTAL NET SALES     9,378          7,531         12,240         10,134
Other revenues      45             (7)           59             (10)
TOTAL REVENUES      9,423          7,523         12,299         10,124
Cost of sales       (5,534)        (4,725)       (7,222)        (6,358)
GROSS PROFIT        3,889          2,798         5,076          3,766
Research &
development         (673)          (591)         (878)          (795)
expenses
S, G & A expenses   (2,963)        (2,579)       (3,867)        (3,470)
Total operating     (3,636)        (3,170)       (4,745)        ( 4,265)
expenses
OPERATING PROFIT    254            (371)         331            (499)
(LOSS)
Interest (expense)  (591)         (233)        (772)          (313)
income, net
Currency exchange   (735)          287           (959)          386
gains (loss), net
Other income        --             3             --             5
(loss), net
INCOME (LOSS)
BEFORE TAXES AND    (1,073)        (313)         (1,400)        (422)
MINORITY INTEREST
Income tax          (26)           (266)         (34)           (357)
(expense) credit
                                                            
NET INCOME (LOSS)   (1,099)        (579)         (1,434)        (779)
Earning per share – (0.06)         (0.04)        (0.08)         (0.06)
Basic
Average number of
shares used         18,372,229     13,227,043    18,372,229     13,227,043
incomputation of
EPS
Earning per share – (0.06)         (0.04)        (0.08)         (0.06)
Diluted
Average number of
shares used
incomputation of   18,780,920     13,317,115    18,780,920     13,317,115
EPS for positive
net income
                                                            
NOTE:Translated for convenience of the reader to U.S. dollars at the 2012
average three months noon buying rate of 1 Euro = 1.3051 USD, and 2011 average
three months noon buying rate of 1 Euro = 1.3457 USD.


EDAP TMS S.A.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands of Euros and U.S. Dollars, except per share data)
                                                   
                           Twelve Months Ended:     Twelve Months Ended:
                            December31,  December   December31,  December
                           2012          31,       2012           31,
                            Euros        2011       $US            2011
                                          Euros                     $US
Sales of medical          17,900          12,399     21,959         17,361
equipment
Net Sales of RPP and      3,988           4,508      5,148        6, 312
Leases
Sales of spare parts,
supplies and              5,021           5,365      6,482          7,511
Services
TOTAL NET SALES           26,018          22,272     33,589         31,184
Other revenues            47              20         61             28
TOTAL REVENUES            26,065          22,292     33,650         31,212
Cost of sales             (15,632)        (13,435)   (20,181)       (18,811)
GROSS PROFIT              10,433          8,857      13,469         12,401
Research & development    (2,659)         (2,436)    (3,432)        (3,411)
expenses
S, G & A expenses         (9,805)         (8,917)    (12,658)       (12,486)
Total operatingexpenses  (12,463)        (11 ,353)  (16,090)       (15,897)
OPERATING PROFIT (LOSS)   (2,030)         (2,497)    (2,621)        (3,496)
Interest (expense)        (4,594)         1,522      (5,931)        2,131
income, net
Currency exchange gains   (733)           482        (947)          675
(loss), net
Other income (loss), net  --              (50)       --             (70)
INCOME (LOSS) BEFORE
TAXES AND MINORITY        (7,358)         (543)      (9,499)        (761)
INTEREST
Income tax (expense)      (118)           (395)      (152)          (553)
credit
NET INCOME (LOSS)         (7,475)         (938)      (9,651)        (1,314)
Earning per share – Basic (0.43)          (0.07)     (0.55)         (0.10)
Average number of shares
used incomputation of    17,556,395      13,345,004 17,556,395     13,345,004
EPS
Earning per share –       (0.43)          (0.07)     (0.55)         (0.10)
Diluted
Average number of shares
used incomputation of
EPS for positive net      17,944,651      13,353,985 17,944,651     13,353,985
income


                                                                
NOTE:Translated for convenience of the reader to U.S. dollars at the 2012
average twelve months noon buying rate of 1 Euro =1.2910 USD, and 2011
average twelve months noon buying rate of 1 Euro =1.4002 USD.
                                                               

                                      

EDAP TMS S.A.
CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (UNAUDITED)
(Amounts in thousands of Euros and U.S. Dollars)
                                                             
                        Dec.31,     Sept.30,     Dec.31,     Sept.30,
                       2012         2012          2012         2012
                        Euros       Euros         $US          $US
Cash, cash equivalents
and shortterm          8,077         8,145         10,650       10,472
investments
Total current assets    24,729        24,831        32,607       31,924
Total current           13,124        12,968        17,305       16,672
liabilities
Shareholders' Equity    8,161         8,847         10,761       11,374
                                                             
NOTE:Translated for convenience of the reader to U.S. dollars at the noon
buying rate of 1 Euro = 1.3186USD, on December 31, 2012 and at the noon buying
rate of 1 Euro = 1.2857 USD, on September 30, 2012.



        EDAP TMS S.A.                                                       
        CONDENSED STATEMENTS OF OPERATIONS BY DIVISION                      
        TWELVE MONTHS ENDED DECEMBER 31, 2012                               
        (Amounts in thousands of Euros)                                     
                                                                   
               HIFU        UDS         FDA     Corporate Total After    
                 Division     Division     Trials            Consolidation
Sales of goods  1,884        15,125                      17,009     
Sales of RPPs & 2,695        1,293                       3,988      
Leases
Sales of spare
parts &         1,006        4,015                       5,021      
services
TOTAL NET SALES 5,585        20,433                      26,018     
                                                                
Other revenues  47           --                          47         
                                                                
TOTAL REVENUES  5,632        20,433                      26,065     
                                                                
GROSS PROFIT    2,723     48% 7,710    38%                 10,433     40%
                                                                
Research &      (920)        (746)       (992)            (2,659)    
Development
Total SG&A plus (2,548)      (5,809)     (97)    (1,352)   (9,805)    
depreciation
OPERATING       (746)        1,156       (1,089) (1,352)   (2,030)    
PROFIT (LOSS)

CONTACT: Blandine Confort
         Investor Relations / Legal Affairs
         EDAP TMS SA
         +33 4 72 15 31 72
         bconfort@edap-tms.com
        
         Investors:
         Stephanie Carrington
         The Ruth Group
         646-536-7017
         scarrington@theruthgroup.com
 
Press spacebar to pause and continue. Press esc to stop.