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
15,
2008
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 Form 20-F or Form 40-F.
Form
20-F
x Form 40-F o
Indicate
by check mark whether the registrant by furnishing the information contained
in
this Form is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes
o
No
x
This
report on Form 6-K is hereby incorporated by reference in the registration
statement of EDAP TMS S.A. on Forms F-3, file number 333-136811 and
333-147762.
PRESS
RELEASE
|
Contact:
Blandine
Confort
Investor
Relations / Legal Affairs
EDAP
TMS SA
+33
4 72 15 31 72
bconfort@edap-tms.com
|
Investors:
R.J.
Pellegrino
The
Ruth Group
646-536-7009
rpellegrino@theruthgroup.com
|
EDAP Reports
First Quarter 2008 Financial Results
First
Quarter 2008 Highlights:
| · |
Total
HIFU revenue of EUR 2.2 million, up 39% year-over-year
|
| · |
Gross
margin increased to 44.1% compared to 43.1% in the first quarter
of
2007
|
| · |
Continued
progress in U.S. ENLIGHT clinical study driven by IRB approval
of 11
premiere Ablatherm and 8 Cryotherapy sites
|
| · |
25%
ENLIGHT enrollment growth in past six weeks
|
LYON,
France, May 15, 2008
- EDAP
TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, announced
today
financial results for the first quarter ended March 31, 2008.
For
the
first quarter 2008, the Company reported total revenue of EUR 4.5 million,
compared to EUR 4.7 million for the same period in 2007. The first quarter
2008
total revenues were driven by strong growth in HIFU sales partially offset
by
lower lithotripsy sales.
Total
Revenues for the Company’s HIFU division increased 38.6% to EUR 2.2 million in
the first quarter of 2008, compared to EUR 1.6 million in the same period
of
2007. The increase was primarily driven by growth in Ablatherm-HIFU machine
sales. During the first quarter 2008, the Company sold two machines, compared
to
zero in the first quarter of 2007.
Total
Revenues for the Company’s lithotripsy division were EUR 2.3 million in first
quarter 2008, compared to EUR 3.0 million reported in the same period last
year.
The
decrease reflected lower machine sales following a very strong fourth quarter
in
2007. In the first quarter 2008, a total of five machines were sold. At the
beginning of the second quarter 2008, the Company has
a
backlog of seven machines, including two Sonolith I-sys devices and is well
positioned for a return to historical sales levels for the remainder of the
year.
Gross
profit for the first quarter 2007 was EUR 2.0 million, flat from the first
quarter of 2007. Gross profit margin increased to 44.1% in the first quarter
of
2008, compared to 43.1% in the first quarter of 2007. The increased margin
was
based on the sale of two HIFU machines partially offset by lower lithotripsy
sales.
Operating
expenses were EUR 3.5 million in the first quarter 2008, compared to EUR
3.1
million for the same period of 2007. This increase primarily reflected a
EUR 0.5
million expense related to the U.S. FDA ENLIGHT clinical trial for
Ablatherm.
Operating
loss was EUR 1.5 million for the first quarter 2008, compared to operating
loss
of EUR 1.1 million for the first quarter 2007.
Net
income for the first quarter 2008 was EUR 1.1 million, or EUR 0.11 per diluted
share, compared to a net loss of EUR 1.2 million, or EUR 0.14 per diluted
share,
in 2007. First quarter 2008 net income included a EUR 2.7 million non-cash
financial gain related to the adjustment of the Company’s convertible preferred
debt and outstanding warrants to fair value and a EUR 1.0 million currency
exchange gain due to the weakening of the U.S. dollar against the
Euro.
Cash
and
cash equivalents including short-term treasury investments were EUR 15.5
million
(USD 24.6 million) at March 31, 2008.
Marc
Oczachowski, EDAP’s Chief Executive Officer, commented, “We are especially
pleased with the Ablatherm-HIFU sales growth coupled with continued progress
in
our U.S. ENLIGHT clinical study evaluating the use of minimally invasive
therapeutic ultrasound in patients with localized prostate cancer. As
anticipated, RPP revenue was impacted by the transition of two large hospitals
to direct ownership of our capital equipment and a slower start in January
and
February. We are experiencing a return to stronger RPP growth in March.”
Mr.
Oczachowski continued, “We have made substantial progress on our U.S. clinical
development program during the first quarter, receiving IRB approval of
additional participating sites, including the premier Memorial Sloan Kettering
and University of Texas M.D. Anderson Cancer Centers. The continued evaluation
of HIFU by such industry thought leaders, combined with our patient program
has
consistently raised the profile of our technology in the clinical community.
They have been instrumental in driving our recruitment efforts and expediting
access to this novel and minimally invasive treatment alternative.
HIFU
technology continues to gain traction among the scientific and medical community
as a safe and effective treatment option for various applications. We believe
our strong IP portfolio and demonstrated experience leave EDAP well positioned
to participate in the growth and development of future minimally invasive
HIFU
options that will benefit patients across multiple pathologies. We will continue
to leverage our twenty years of HIFU expertise and experience aimed at achieving
improved therapeutic solutions. As proof of our support and commitment towards
HIFU innovation, we, together with INSERM and Epitarget have recently announced
our involvement with HIFU and its utilization in liposome drug delivery.
Our
ability to secure patent rights on our innovations and protect the strength
of
our intellectual property estate is of critical importance.”
Conference
Call
EDAP
will
hold a conference call on Thursday, May 15, 2008 at 8:30 a.m. ET to discuss
the
results. The dial-in numbers are 1-888-241-0558 for domestic callers and
1-647-427-3417 for international. The conference ID number for both is 46509351.
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
July 15, 2008. In addition, a telephonic replay of the call will be available
until May 20, 2008. The replay dial-in numbers are 1-800-839-4177 for domestic
callers and 1-402-220-2901 for international callers. Please use event ID
number
46509351.
About
EDAP TMS SA
EDAP
TMS
SA develops and markets Ablatherm, the most advanced and clinically proven
choice 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. Approved in Europe as
a
treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused
Ultrasound) is currently undergoing evaluation in a multicenter U.S. Phase
II/III clinical trial under an Investigational Device Exemption granted by
the
FDA. The Company also is developing this technology for the potential treatment
of certain other types of tumors. EDAP TMS SA also produces and commercializes
medical equipment 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
or
http://www.urotoday.com/HIFU.
#
#
#
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,
2008
|
March
31,
2007
|
March
31,
2008
|
March
31,
2007
|
||||||||||
|
Euros
|
Euros
|
$US
|
$US
|
||||||||||
|
Sales
of goods
|
1,940
|
1,902
|
2,963
|
2,508
|
|||||||||
|
Net
Sales of RPP and Leases
|
1,123
|
1,308
|
1,715
|
1,725
|
|||||||||
|
Sales
of spare parts and Services
|
1,369
|
1,420
|
2,092
|
1,872
|
|||||||||
|
TOTAL
NET SALES
|
4,432
|
4,630
|
6,770
|
6,105
|
|||||||||
|
Other
revenues
|
64
|
36
|
98
|
47
|
|||||||||
|
TOTAL
REVENUES
|
4,496
|
4,666
|
6,869
|
6,152
|
|||||||||
|
Cost
of goods
|
(1,198
|
)
|
(1,273
|
)
|
(1,830
|
)
|
(1,679
|
)
|
|||||
|
Cost
of RPP and Leases
|
(570
|
)
|
(568
|
)
|
(871
|
)
|
(750
|
)
|
|||||
|
Cost
of spare parts & services
|
(772
|
)
|
(831
|
)
|
(1,180
|
)
|
(1,095
|
)
|
|||||
|
Cost
of sales
|
(2,540
|
)
|
(2,672
|
)
|
(3,880
|
)
|
(3,524
|
)
|
|||||
|
GROSS
PROFIT
|
1,956
|
1,994
|
2,988
|
2,629
|
|||||||||
|
Research
& development expenses
|
(983
|
)
|
(616
|
)
|
(1,502
|
)
|
(813
|
)
|
|||||
|
Marketing
& Sales expenses
|
(1,398
|
)
|
(1,341
|
)
|
(2,136
|
)
|
(1,768
|
)
|
|||||
|
G
& A expenses
|
(1,114
|
)
|
(1,183
|
)
|
(1,702
|
)
|
(1,560
|
)
|
|||||
|
Total
operating expenses
|
(3,496
|
)
|
(3,140
|
)
|
(5,340
|
)
|
(4,141
|
)
|
|||||
|
OPERATING
PROFIT (LOSS)
|
(1,540
|
)
|
(1,147
|
)
|
(2,352
|
)
|
(1,512
|
)
|
|||||
|
Interest
(expense) income, net
|
2,279
|
3
|
3,482
|
4
|
|||||||||
|
Currency
exchange gains (loss), net
|
340
|
(48
|
)
|
519
|
(63
|
)
|
|||||||
|
Other
income (loss), net
|
7
|
3
|
11
|
4
|
|||||||||
|
INCOME
(LOSS) BEFORE TAXES AND MINORITY INTEREST
|
1,086
|
(1,188
|
)
|
1,660
|
(1,567
|
)
|
|||||||
|
Income
tax (expense) credit
|
(21
|
)
|
(21
|
)
|
(32
|
)
|
(27
|
)
|
|||||
|
NET
INCOME (LOSS)
|
1,066
|
(1,209
|
)
|
1,628
|
(1,594
|
)
|
|||||||
|
Earning
per share - Basic
|
0.12
|
(0.14
|
)
|
0.18
|
(0.18
|
)
|
|||||||
|
Average
number of shares used in computation of EPS
|
9,200,757
|
8,942,007
|
9,200,757
|
8,942,007
|
|||||||||
|
Earning
per share - Diluted
|
0.11
|
(0.14
|
)
|
0.17
|
(0.18
|
)
|
|||||||
|
Average
number of shares used in computation of EPS for positive net
income
|
9,444,126
|
9,606,863
|
9,444,126
|
9,606,863
|
|||||||||
NOTE:
Translated for convenience of the reader to U.S. dollars at the 2008 average
three months noon buying rate of 1 Euro = 1.5278 USD, and 2007 average three
months noon buying rate of 1 Euro = 1.3186 USD.
EDAP
TMS S.A.
CONSOLIDATED
BALANCE SHEETS HIGHLIGHTS (UNAUDITED)
(Amounts
in thousands of Euros and U.S. Dollars)
|
Mar.
31,
2008
Euros
|
Dec.
31,
2007
Euros
|
Mar.
31,
2008
$US
|
Dec.
31,
2007
$US
|
||||||||||
|
Cash,
cash equivalents and short term investments
|
15,542
|
18,611
|
24,565
|
27,178
|
|||||||||
|
Total
current assets
|
32,298
|
36,123
|
51,047
|
52,751
|
|||||||||
|
Total
current liabilities
|
11,329
|
12,884
|
17,906
|
18,815
|
|||||||||
|
Shareholders’
Equity
|
15,701
|
14,498
|
24,815
|
21,171
|
|||||||||
NOTE:
Translated for convenience of the reader to U.S. dollars at the noon buying
rate
of 1 Euro = 1.5805 USD, on March 31, 2008 and at the noon buying rate of
1 Euro
= 1.4603 USD, on December 31, 2007.
EDAP
TMS S.A.
CONDENSED
STATEMENTS OF OPERATIONS BY DIVISION
THREE
MONTHS ENDED MARCH 31, 2008
(Amounts
in thousands of Euros)
|
HIFU
Division
|
UDS
Division
|
FDA
Trials
|
Corporate
|
Total
After Consolidation
|
|||||||||||||||||||||
|
Sales
of goods
|
945
|
994
|
1,940
|
||||||||||||||||||||||
|
Sales
of RPPs & Leases
|
872
|
251
|
1,123
|
||||||||||||||||||||||
|
Sales
of spare parts & services
|
374
|
995
|
1,369
|
||||||||||||||||||||||
|
TOTAL
NET SALES
|
2,192
|
2,240
|
4,432
|
||||||||||||||||||||||
|
Other
revenues
|
48
|
16
|
64
|
||||||||||||||||||||||
|
TOTAL
REVENUES
|
2,240
|
2,256
|
4,496
|
||||||||||||||||||||||
|
GROSS
PROFIT
|
1,401
|
65
|
%
|
555
|
24
|
%
|
1,956
|
44
|
%
|
||||||||||||||||
|
Research
& Development
|
(247
|
)
|
(261
|
)
|
(475
|
)
|
(983
|
)
|
|||||||||||||||||
|
Total
SG&A plus depreciation
|
(1,026
|
)
|
(895
|
)
|
(34
|
)
|
(559
|
)
|
(2,513
|
)
|
|||||||||||||||
|
OPERATING
PROFIT (LOSS)
|
127
|
(600
|
)
|
(508
|
)
|
(559
|
)
|
(1,540
|
)
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
Date
:
May 15, 2008
EDAP
TMS
S.A.
/S/
MARC
OCZACHOWSKI
MARC
OCZACHOWSKI
CHIEF
EXECUTIVE OFFICER