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
September
4, 2008
2008
Second Quarter Financial Results
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, 333-147762
and
333-152738.
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
Second Quarter 2008 Financial Results
LYON,
France, August 21, 2008 –
EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound,
announced today
financial results for the second quarter ended June 30, 2008.
For
the
second quarter 2008, the Company reported total revenue of EUR 5.0 million
(USD
7.8 million), compared to EUR 5.9 million (USD 8.0 million) for the same period
in 2007. Total revenue for the second quarter 2008 reflected already experienced
seasonal HIFU device sales fluctuations, partially offset by the anticipated
return of strong lithotripsy sales over the period
Total
revenue for the Company’s HIFU division was EUR 1.6 million (USD 2.6 million) in
the second quarter 2008, compared to EUR 2.8 million (USD 3.8 million) in the
same period of 2007. The second quarter 2008 faced a challenging year-over-year
revenue comparison due to no sales of the Ablatherm-HIFU system versus two
in
the second quarter of 2007, including one high-priced unit. As the Company
has
previously indicated, quarterly revenues may be impacted by fluctuating HIFU
device sales. For the six months ended June 30, 2008, the Company sold a total
of two Ablatherm-HIFU systems equivalent to the number of HIFU devices sold
during the same period of last year.
Total
revenue for the Company’s lithotripsy division was EUR 3.3 million (USD 5.2
million) in the second quarter 2008, compared to EUR 3.1 million (USD 4.2
million) for the same period last year and up 47.9% sequentially.
The
increase was attributed to the sale of ten machines, including two Sonolith
I-Sys devices, during the second quarter 2008. Higher machine sales were
consistent with the Company’s statement during the first quarter 2008, which
indicated that seven machines were in backlog, including two Sonolith I-sys
devices. As anticipated, the Company converted much of its first quarter 2008
backlog into revenue during the second quarter of 2008. At the beginning of
the
third quarter 2008, the Company has a backlog of eight machines, including
five
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 second quarter 2008 was EUR 1.9 million (USD 2.9 million),
compared to EUR 2.3 million (USD 3.1 million) from the second quarter of 2007.
Gross profit margin was 37.9% in the second quarter of 2008, compared to 39.5%
in the second quarter of 2007 based on lower HIFU capital equipment sales.
For
the six months ended June 30, 2008, gross profit margin remained flat at 41%.
Gross profit margin for the Company’s HIFU division increased to 62.3% in the
first six months of 2008 compared to 59.9% in the same period of 2007.
Operating
expenses were EUR 3.3 million (USD 5.1 million) in the second quarter 2008,
compared to EUR 3.1 million (USD 4.1 million) for the same period of 2007.
The
increase primarily reflected an expense of EUR 0.5 million related to the U.S.
FDA ENLIGHT clinical trial for Ablatherm. Operating
loss was EUR 1.4 million for the second quarter 2008, compared to operating
loss
of EUR 0.7 million for the second quarter 2007.
Net
income for the second quarter 2008 was EUR 0.9 million, or EUR 0.10 per diluted
share, compared to a net loss of EUR 0.7 million, or EUR 0.08 per diluted share,
in 2007. Second quarter 2008 net income included a non-cash gain of EUR 3.0
million related to the adjustment to fair value of the Company’s convertible
preferred debt and outstanding warrants (shown on the interest line).
Cash
and
cash equivalents, including short-term treasury investments, were EUR 13.4
million (USD 21.1 million) at June 30, 2008, as planned.
Marc
Oczachowski, EDAP’s Chief Executive Officer, commented, “We are encouraged by
lithotripsy sales growth, driven by the continued penetration of our
next-generation Sonolith-I-sys device, which targets the high-end market. We
have seen a return to machine sales growth in the second quarter 2008 and
already have a strong backlog of machines going forward into the third quarter.
We believe this positions us well for a return to historical sales levels in
the
second half of 2008. Our HIFU revenue was impacted by the typical quarterly
fluctuations in our capital equipment sales. While it created a difficult
comparison, we are encouraged, entering the third quarter, by the sale of one
Ablatherm device to Russia which is expected to drive HIFU revenue in the second
half of 2008 and assist in our efforts to increase penetration in Europe. Our
RPP business remained flat over the quarter reaching a steady level of HIFU
treatments performed each quarter. The Management, supported by the Board of
Directors, convened all Sales & Marketing Managers of each key country and
implemented an aggressive RPP action plan to increase RPP sales efforts. We
look
forward to seeing positive outcomes very soon.”
Mr.
Oczachowski added, “In the US, we continued to make progress on our U.S. ENLIGHT
clinical trial during the quarter, as the world-renowned M.D. Anderson Cancer
Center treated its first two localized prostate cancer patients with
Ablatherm-HIFU. Attracting leading cancer centers while promoting the study
to
patients is part of our strategy to gain HIFU visibility and accelerate patient
enrollment as we advance towards pre market approval submission to the FDA,
with
an anticipated approval in 2012. In addition, during the second quarter 2008,
we
were proud to announce validation of our HIFU treatment by a scientific
independent society when the French Association of Urology acknowledged HIFU
as
a standard of care for select primary care patients with localized prostate
cancer. This publication marked a clear milestone for our technology and further
underscores Ablatherm-HIFU’s clinical superiority and treatment potential across
multiple pathologies.”
Conference
Call
EDAP
will
hold a conference call on Thursday, August 21, 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 59091975. A live Webcast of the conference call will be available
online from the investor relations page of the Company’s new 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
November 21, 2008. In addition, a telephonic replay of the call will be
available until August 26, 2008. The replay dial-in numbers are 1-800-766-3146
for domestic callers and 1-402-220-7733 for international callers. Please use
event ID number 59091975.
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, http://www.hifu-planet.com
and
http://www.pcaresearch.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 :
|
|
||||||||
|
|
|
June 30,
2008
Euros
|
|
June 30,
2007
Euros
|
|
June 30,
2008
$US
|
|
June 30,
2007
$US
|
|||||
|
Sales of goods
|
2,303
|
3,261
|
3,599
|
4,417
|
|||||||||
|
Net
Sales of RPP and Leases
|
1,191
|
1,262
|
1,862
|
1,710
|
|||||||||
|
Sales
of spare parts and Services
|
1,447
|
1,410
|
2,261
|
1,910
|
|||||||||
|
TOTAL
NET SALES
|
4,942
|
5,933
|
7,721
|
8,036
|
|||||||||
|
Other
revenues
|
27
|
14
|
43
|
19
|
|||||||||
|
TOTAL
REVENUES
|
4,969
|
5,947
|
7,764
|
8,055
|
|||||||||
|
Cost
of goods
|
(1,645
|
)
|
(2,085
|
)
|
(2,570
|
)
|
(2,824
|
)
|
|||||
|
Cost
of RPP and Leases
|
(634
|
)
|
(549
|
)
|
(990
|
)
|
(744
|
)
|
|||||
|
Cost
of spare parts & services
|
(817
|
)
|
(967
|
)
|
(1,276
|
)
|
(1,309
|
)
|
|||||
|
Cost
of sales
|
(3,095
|
)
|
(3,601
|
)
|
(4,836
|
)
|
(4,877
|
)
|
|||||
|
GROSS
PROFIT
|
1,874
|
2,346
|
2,928
|
3,178
|
|||||||||
|
Research
& development expenses
|
(1,104
|
)
|
(943
|
)
|
(1,726
|
)
|
(1,277
|
)
|
|||||
|
Marketing
& Sales expenses
|
(1,282
|
)
|
(1,322
|
)
|
(2,003
|
)
|
(1,790
|
)
|
|||||
|
G
& A expenses
|
(888
|
)
|
(1,235
|
)
|
(1,388
|
)
|
(1,673
|
)
|
|||||
|
Non-recurring
profit / (expenses)
|
441
|
598
|
|||||||||||
|
Total
operating expenses
|
(3,274
|
)
|
(3,059
|
)
|
(5,116
|
)
|
(4,142
|
)
|
|||||
|
OPERATING
PROFIT (LOSS)
|
(1,400
|
)
|
(712
|
)
|
(2,188
|
)
|
(965
|
)
|
|||||
|
Interest
(expense) income, net
|
2,533
|
3
|
3,957
|
4
|
|||||||||
|
Currency
exchange gains (loss), net
|
(406
|
)
|
(180
|
)
|
(634
|
)
|
(244
|
)
|
|||||
|
Other
income (loss), net
|
1
|
9
|
1
|
12
|
|||||||||
|
INCOME
(LOSS) BEFORE TAXES AND MINORITY INTEREST
|
728
|
(880
|
)
|
1,137
|
(1,192
|
)
|
|||||||
|
Income
tax (expense) credit
|
205
|
144
|
320
|
195
|
|||||||||
|
NET
INCOME (LOSS)
|
932
|
(736
|
)
|
1,457
|
(997
|
)
|
|||||||
|
Earning
per share – Basic
|
0.10
|
(0.08
|
)
|
0.16
|
(0.11
|
)
|
|||||||
|
Average
number of shares used in computation of EPS
|
9,200,757
|
9,163,007
|
9,200,757
|
9,163,007
|
|||||||||
|
Earning
per share – Diluted
|
0.10
|
(0.08
|
)
|
0.16
|
(0.11
|
)
|
|||||||
|
Average
number of shares used in computation of EPS for positive net
income
|
9,276,459
|
9,543,569
|
9,276,459
|
9,543,569
|
|||||||||
NOTE:
Translated for convenience of the reader to U.S. dollars at the 2008 average
three months noon buying rate of 1 Euro = 1.5625 USD, and 2007 average three
months noon buying rate of 1 Euro = 1.3544 USD.
EDAP
TMS S.A.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts
in thousands of Euros and U.S. Dollars, except per share
data)
|
Six Months Ended :
|
Six Months Ended :
|
||||||||||||
|
June 30,
2008
Euros
|
June 30,
2007
Euros
|
June 30,
2008
$US
|
June 30,
2007
$US
|
||||||||||
|
Sales of
goods
|
4,243
|
5,163
|
6,556
|
6,900
|
|||||||||
|
Net
Sales of RPP and Leases
|
2,314
|
2,571
|
3,576
|
3,436
|
|||||||||
|
Sales
of spare parts and Services
|
2,816
|
2,830
|
4,352
|
3,782
|
|||||||||
|
TOTAL
NET SALES
|
9,373
|
10,564
|
14,483
|
14,118
|
|||||||||
|
Other
revenues
|
92
|
49
|
141
|
66
|
|||||||||
|
TOTAL
REVENUES
|
9,465
|
10,613
|
14,624
|
14,184
|
|||||||||
|
Cost
of goods
|
(2,847
|
)
|
(3,358
|
)
|
(4,398
|
)
|
(4,488
|
)
|
|||||
|
Cost
of RPP and Leases
|
(1,203
|
)
|
(1,117
|
)
|
(1,860
|
)
|
(1,493
|
)
|
|||||
|
Cost
of spare parts & services
|
(1,585
|
)
|
(1,797
|
)
|
(2,449
|
)
|
(2,402
|
)
|
|||||
|
Cost
of sales
|
(5,635
|
)
|
(6,273
|
)
|
(8,707
|
)
|
(8,384
|
)
|
|||||
|
GROSS
PROFIT
|
3,830
|
4,340
|
5,918
|
5,800
|
|||||||||
|
Research
& development expenses
|
(2,087
|
)
|
(1,559
|
)
|
(3,225
|
)
|
(2,084
|
)
|
|||||
|
Marketing
& Sales expenses
|
(2,680
|
)
|
(2,663
|
)
|
(4,141
|
)
|
(3,559
|
)
|
|||||
|
G
& A expenses
|
(2,003
|
)
|
(2,418
|
)
|
(3,095
|
)
|
(3,232
|
)
|
|||||
|
Non-recurring
profit / (expenses)
|
441
|
590
|
|||||||||||
|
Total
operating expenses
|
(6,770
|
)
|
(6,199
|
)
|
(10,460
|
)
|
(8,285
|
)
|
|||||
|
OPERATING
PROFIT (LOSS)
|
(2,940
|
)
|
(1,859
|
)
|
(4,542
|
)
|
(2,484
|
)
|
|||||
|
Interest
(expense) income, net
|
4,812
|
6
|
7,434
|
9
|
|||||||||
|
Currency
exchange gains (loss), net
|
(66
|
)
|
(228
|
)
|
(102
|
)
|
(305
|
)
|
|||||
|
Other
income (loss), net
|
8
|
12
|
12
|
16
|
|||||||||
|
INCOME
(LOSS) BEFORE TAXES AND MINORITY INTEREST
|
1,814
|
(2,069
|
)
|
2,803
|
(2,765
|
)
|
|||||||
|
Income
tax (expense) credit
|
184
|
124
|
285
|
165
|
|||||||||
|
NET
INCOME (LOSS)
|
1,998
|
(1,945
|
)
|
3,087
|
(2,600
|
)
|
|||||||
|
Earning
per share – Basic
|
0.22
|
(0.21
|
)
|
0.34
|
(0.28
|
)
|
|||||||
|
Average
number of shares used in computation of EPS
|
9,200,757
|
9,163,007
|
9,200,757
|
9,163,007
|
|||||||||
|
Earning
per share – Diluted
|
0.22
|
(0.21
|
)
|
0.34
|
(0.28
|
)
|
|||||||
|
Average
number of shares used in computation of EPS for positive net
income
|
9,276,459
|
9,685,022
|
9,276,459
|
9,685,022
|
|||||||||
NOTE:
Translated for convenience of the reader to U.S. dollars at the 2008 average six
months noon buying rate of 1 Euro = 1.5452 USD, and 2007 average six months
noon
buying rate of 1 Euro = 1.3365 USD.
EDAP
TMS S.A.
CONSOLIDATED
BALANCE SHEETS HIGHLIGHTS (UNAUDITED)
(Amounts
in thousands of Euros and U.S. Dollars)
|
June 30,
2008
Euros
|
Mar. 31,
2008
Euros
|
June 30,
2008
$US
|
Mar. 31,
2008
$US
|
||||||||||
|
Cash,
cash equivalents and short term investments
|
13,406
|
15,542
|
21,112
|
24,565
|
|||||||||
|
Total
current assets
|
31,061
|
32,298
|
48,176
|
51,047
|
|||||||||
|
Total
current liabilities
|
11,580
|
11,329
|
18,236
|
17,906
|
|||||||||
|
Shareholders’
Equity
|
16,758
|
15,701
|
26,391
|
24,815
|
|||||||||
NOTE:
Translated for convenience of the reader to U.S. dollars at the noon buying
rate
of 1 Euro = 1.5748 USD, on June 30, 2008 and at the noon buying rate of 1 Euro
=
1.5805 USD, on March 31, 2008.
EDAP
TMS S.A.
CONDENSED
STATEMENTS OF OPERATIONS BY DIVISION
SIX
MONTHS ENDED JUNE 30, 2008
(Amounts
in thousands of Euros)
|
HIFU Division
|
|
UDS Division
|
|
FDA Trials
|
|
Corporate
|
|
Total After
Consolidation
|
||||||||
|
Sales
of goods
|
1,195
|
3,048
|
4,243
|
|||||||||||||
|
Sales
of RPPs & Leases
|
1,785
|
529
|
2,314
|
|||||||||||||
|
Sales
of spare parts & services
|
832
|
1,984
|
2,816
|
|||||||||||||
|
TOTAL
NET SALES
|
3,811
|
5,562
|
9,373
|
|||||||||||||
|
Other
revenues
|
62
|
29
|
92
|
|||||||||||||
|
TOTAL
REVENUES
|
3,873
|
5,591
|
9,465
|
|||||||||||||
|
GROSS
PROFIT
|
2,375
|
61%
|
1,456
|
26%
|
3,830
|
41%
|
||||||||||
|
Research
& Development
|
(574
|
)
|
(533
|
)
|
(981
|
)
|
(2,087
|
)
|
||||||||
|
Total
SG&A plus depreciation
|
(1,828
|
)
|
(1,764
|
)
|
(40
|
)
|
(1,051
|
)
|
(4,682
|
)
|
||||||
|
OPERATING
PROFIT (LOSS)
|
(27
|
)
|
(841
|
)
|
(1,021
|
)
|
(1,051
|
)
|
(2,940
|
)
|
||||||
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
:
September 4, 2008
EDAP
TMS
S.A.
/S/
MARC
OCZACHOWSKI
MARC
OCZACHOWSKI
CHIEF
EXECUTIVE OFFICER