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
March
26,
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 - FOR IMMEDIATE 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
Fourth Quarter and Full Year 2007 Financial Results
Highlights:
| · |
Record
fourth quarter revenue of EUR 7.0 million, up 44%
year-over-year
|
| · |
Full
year revenue of EUR 22.3 million, up 10%
year-over-year
|
| · |
Approximately
3,400 Ablatherm-HIFU treatments in 2007; 15,000 cumulative treatments
at
176 clinical sites
|
| · |
Full
year Ablatherm-HIFU RPP treatments increased 36% year-over-year
|
| · |
Full
year gross profit of EUR
9.2 million, up 10% year-over-year; gross profit margin of
41.3%
|
| · |
Ablatherm-HIFU
U.S. clinical trials continue to progress with successful launch
of
patient awareness program and fully funded by USD 20 million
convertible
debt raise
|
| · |
Launch
of integrated Sonolith I-Sys for the disintegration of urinary
tract
stones
|
LYON,
France, March 26, 2008
- EDAP
TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, announced
today
financial results for the fourth quarter and full year ended December 31,
2007.
Fourth
Quarter 2007 Results
For
the
fourth quarter 2007, the Company reported total revenue of EUR 7.0 million,
a
43.8% increase from EUR 4.9 million for the same period in 2006. The fourth
quarter 2007 total revenues reflected the anticipated strong seasonality
for
hospital capital equipment sales.
Net
sales
for the Company’s HIFU division increased 23.2% to EUR 3.0 million in the fourth
quarter of 2007, compared to EUR 2.4 million in the same period of 2006.
The
increase was primarily driven by growth in Ablatherm-HIFU machine sales.
During
the fourth quarter 2007, three machines were sold, which was the strongest
quarter of the year.
Net
sales
for the Company’s lithotripsy division were EUR 4.0 million in fourth quarter
2007, a 61.3% increase from EUR 2.5 million reported for the same period
last
year.
The
increase in net sales for the lithotripsy division reflected the launch
of the
Sonolith I-sys machine, the Company’s latest generation lithotripsy machine. In
the fourth quarter 2007, the machines sold totaled thirteen, three of which
were
Sonolith I-sys devices.
Gross
profit increased 68.9% to EUR 3.0 million for the fourth quarter 2007,
compared
to EUR 1.8 million for the same period of 2006. Gross profit margin increased
to
43.1% in the fourth quarter of 2007.
Operating
expenses were EUR 3.8 million in the fourth quarter 2007, compared to EUR
2.9
million for the same period of 2006. This increase primarily reflected
expenses
related to the U.S. FDA clinical trial for Ablatherm and our marketing
and
educational initiatives in Europe to build adoption of our HIFU
technology.
Operating
loss was EUR 741,000 for the fourth quarter 2007, compared to operating
loss of
EUR 1.1 million for the fourth quarter 2006.
The
net
loss for fourth quarter 2007 was EUR 2.0 million, or EUR 0.22 per diluted
share,
compared to a net loss of EUR 1.1 million, or EUR 0.13 per diluted share,
in
2006. The fourth quarter 2007 net loss included a EUR 1.2 million non-cash
financial charge related to the adjustment of the Company’s convertible
preferred debt and outstanding warrants to fair value.
Full
Year 2007 Results
For
the
full year 2007, the Company reported total revenue of EUR 22.3 million,
a 10.2%
increase from EUR 20.3 million for the same period in 2006. The majority
of the
increase was due to the transition in the HIFU division to the new revenue
per
procedure (RPP) model and the increase in the number of HIFU treatments.
Net
sales
for the Company’s HIFU division increased 22% to EUR 9.3 million in 2007,
compared to EUR 7.6 million in 2006. The year-over-year change was primarily
driven by a 36% increase in number of Ablatherm-HIFU RPP treatments to
1,273, as
compared to 936 in the prior year. At the end of 2007, cumulative Ablatherm-HIFU
treatments reached over 15,000 at 176 global sites.
Net
sales
for the Company’s lithotripsy division were EUR 12.9 million in 2007, a 3%
increase from EUR 12.6 million reported for the same period last year.
The
increase in net sales for the lithotripsy division was primarily attributable
to
an 8% increase in net sales of medical devices. The year-over-year increase
was
primarily due to sales of three Sonolith I-sys devices; the Company’s recently
launched next-generation lithotripter targeting the high-end market
segment.
Gross
profit increased 10.3% to EUR 9.2 million for 2007, compared to EUR 8.3
million
for the same period of 2006. Gross profit margin for 2007 was stable at
41.3%.
Operating
expenses increased 16.3% to EUR 13.3 million in 2007 from EUR 11.4 million
in
2006. This increase primarily reflected expense related to the U.S. FDA
clinical
trial for Ablatherm and the sustained efforts in Europe to increase market
awareness of the Company’s HIFU technology.
Operating
loss was EUR 4.1 million for 2007, compared to operating loss of EUR 3.1
million
for 2006. The year-over-year change in the operating loss was primarily
due to
increased gross profit offset by increased operating expenses.
The
net
loss for 2007 was EUR 5.4 million, or EUR 0.59 per diluted share, compared
to a
net loss of EUR 3.4 million, or EUR 0.39 per diluted share, in 2006. The
2007
net loss included a EUR 1.2 million non-cash financial charge related to
the
adjustment of the Company’s convertible preferred debt and outstanding warrants
to fair value and a EUR 254,000 currency exchange loss mainly due to the
continuous weakening of the Japanese Yen against the Euro.
Cash
and
cash equivalents including short-term treasury investments were EUR 18.6
million
at December 31, 2007.
Marc
Oczachowski, EDAP’s Chief Executive Officer, commented, “We are pleased to
report record revenue for the fourth quarter, which reflected the positive
seasonality we had expected for hospital capital equipment sales and the
continued execution of our sales and marketing strategy. Our Ablatherm-HIFU
revenue per procedure model added to our positive performance. With over
15,000
Ablatherm treatments performed worldwide, our HIFU technology continues
to
emerge as a consistent, solid and clinically proven therapeutic option
for the
long-term treatment of prostate cancer. We also successfully launched our
next-generation Sonolith I-Sys for the disintegration of urinary tract
stones
with already positive feedback from urologists.
We
were
extremely pleased with the U.S. $20 million convertible debt raise and
the
reception U.S. investors had to the EDAP story. The funds mean that our
U.S.
clinical trials are fully funded and allow us to move these trials ahead
with
the most effective support and marketing to drive patients to the
sites.”
Mr.
Oczachowski continued, “During 2008, we plan to achieve deeper product
penetration and expand our market share across Europe. Our focus is to
strengthen treatment growth at our leading centers, while driving demand
and
increasing awareness of our Ablatherm-HIFU as a treatment for prostate
cancer at
new centers. We continue to remain focused on advancing our Phase
II/III Ablatherm-HIFU
clinical
trials as a major step toward U.S. commercialization. The
ENLIGHT
clinical trial for localized prostate cancer is currently enrolling patients
at
sites in the United States and Canada under an Investigational Device Exemption
granted by the FDA.
The
launch of our patient awareness program in February 2008 was a major milestone
for the Company. We are encouraged by the momentum that Ablatherm-HIFU
is
building in the United States and remain on track to increase enrollment
driven
by our nationwide patient awareness campaign.”
Eric
Soyer, EDAP’s Chief Financial Officer, stated, “We believe our fourth quarter
and full year financial results were in line with our expectations and
reflect
very strong revenue growth across both our HIFU and Lithotripsy businesses.
Our
2007 operating loss was composed of EUR 2.7 million from our European operations
and EUR 1.4 million related to our U.S. operations for the advancement
of our
Ablatherm-HIFU clinical trials. The 2006 operating loss of EUR 3.1 million
was
attributed entirely to operating expenses for Europe as EDAP expended no
costs
related to the U.S. PMA trials in 2006. Our net income was impacted by
a
non-cash charge of EUR 1.2 million related to the fair value adjustment
of our
convertible debt and warrants for the successful completion of
a
$20
million private placement of unsecured convertible debentures. These funds
should allow the Company to drive enrollment and fully complete our ENLIGHT
FDA
clinical trials.”
Conference
Call
EDAP
will
hold a conference call on Wednesday, March 26, 2008 at 8:30 a.m. ET to
discuss
the results. The dial-in numbers are 1-800-374-0113 for
domestic callers and 1-706-758-9607 for international. The conference ID
number
for both is 39006506. 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
June 26, 2008. In addition, a telephonic replay of the call will be available
until April 3, 2008. The replay dial-in numbers are 1-800-642-1687 for
domestic
callers and 1-706-645-9291 for international callers. Please use event
ID number
39006506.
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
:
|
||||||||||||
|
December
31,
2007
Euros
|
December
31,
2006
Euros
|
December
31,
2007
$US
|
|
December
31,
2006
$US
|
|||||||||
|
Sales
of medical equipment
|
4,321
|
2,529
|
6,303
|
3,307
|
|||||||||
|
Net
Sales of RPP and Leases
|
1,238
|
1,014
|
1,806
|
1,326
|
|||||||||
|
Sales
of spare parts, supplies and Services
|
1,437
|
1,368
|
2,096
|
1,789
|
|||||||||
|
TOTAL
NET SALES
|
6,997
|
4,910
|
10,206
|
6,421
|
|||||||||
|
Other
revenues
|
31
|
(25
|
)
|
45
|
(32
|
)
|
|||||||
|
TOTAL
REVENUES
|
7,028
|
4,885
|
10,251
|
6,389
|
|||||||||
|
Cost
of sales
|
(4,012
|
)
|
(3,100
|
)
|
(5,852
|
)
|
(4,054
|
)
|
|||||
|
GROSS
PROFIT
|
3,016
|
1,786
|
4,399
|
2,335
|
|||||||||
|
Research
& development expenses
|
(874
|
)
|
(573
|
)
|
(1,275
|
)
|
(750
|
)
|
|||||
|
S,
G & A expenses
|
(2,354
|
)
|
(2,087
|
)
|
(3,432
|
)
|
(2,729
|
)
|
|||||
|
Non-recurring
operating expenses
|
(529
|
)
|
(195
|
)
|
(772
|
)
|
(255
|
)
|
|||||
|
Total
operating expenses
|
(3,757
|
)
|
(2,855
|
)
|
(5,479
|
)
|
(3,734
|
)
|
|||||
|
OPERATING
PROFIT (LOSS)
|
(741
|
)
|
(1,070
|
)
|
(1,081
|
)
|
(1,399
|
)
|
|||||
|
Interest
(expense) income, net
|
(1,254
|
)
|
66
|
(1,830
|
)
|
86
|
|||||||
|
Currency
exchange gains (loss), net
|
(37
|
)
|
(100
|
)
|
(54
|
)
|
(131
|
)
|
|||||
|
Other
income (loss), net
|
1
|
3
|
2
|
4
|
|||||||||
|
INCOME
(LOSS) BEFORE TAXES AND MINORITY INTEREST
|
(2,031
|
)
|
(1,101
|
)
|
(2,963
|
)
|
(1,439
|
)
|
|||||
|
Income
tax (expense) credit
|
(8
|
)
|
(14
|
)
|
(12
|
)
|
(18
|
)
|
|||||
|
NET
INCOME (LOSS)
|
(2,040
|
)
|
(1,114
|
)
|
(2,975
|
)
|
(1,458
|
)
|
|||||
|
Earning
per share - Basic
|
(0.22
|
)
|
(0.13
|
)
|
(0.32
|
)
|
(0.17
|
)
|
|||||
|
Average
number of shares used in computation of EPS
|
9,201
|
8,817
|
9,201
|
8,817
|
|||||||||
|
Earning
per share - Diluted
|
(0.22
|
)
|
(0.13
|
)
|
(0.32
|
)
|
(0.17
|
)
|
|||||
|
Average
number of shares used in computation of EPS for positive net
income
|
9,201
|
9,536
|
9,201
|
9,536
|
|||||||||
NOTE:
Translated for convenience of the reader to U.S. dollars at the 2007 average
three months noon buying rate of 1 Euro = 1.4586 USD, and 2006 average
three
months noon buying rate of 1 Euro = 1.3077 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 :
|
||||||||||||
|
December
31,
2007
Euros
|
December
31,
2006
Euros
|
December
31,
2007
$US
|
December
31,
2006
$US
|
||||||||||
|
Sales
of medical equipment
|
11,752
|
10,849
|
16,214
|
13,736
|
|||||||||
|
Net
Sales of RPP and Leases
|
4,814
|
3,805
|
6,642
|
4,818
|
|||||||||
|
Sales
of spare parts, supplies and Services
|
5,647
|
5,520
|
7,792
|
6,989
|
|||||||||
|
TOTAL
NET SALES
|
22,213
|
20,174
|
30,648
|
25,542
|
|||||||||
|
Other
revenues
|
113
|
91
|
156
|
115
|
|||||||||
|
TOTAL
REVENUES
|
22,327
|
20,265
|
30,804
|
25,658
|
|||||||||
|
Cost
of sales
|
(13,148
|
)
|
(11,946
|
)
|
(18,140
|
)
|
(15,125
|
)
|
|||||
|
GROSS
PROFIT
|
9,179
|
8,319
|
12,664
|
10,533
|
|||||||||
|
Research
& development expenses
|
(3,194
|
)
|
(2,442
|
)
|
(4,407
|
)
|
(3,092
|
)
|
|||||
|
S,
G & A expenses
|
(9,850
|
)
|
(8,703
|
)
|
(13,590
|
)
|
(11,019
|
)
|
|||||
|
Non
recurring operating expenses
|
(224
|
)
|
(267
|
)
|
(309
|
)
|
(338
|
)
|
|||||
|
Total
operating expenses
|
(13,268
|
)
|
(11,413
|
)
|
(18,306
|
)
|
(14,449
|
)
|
|||||
|
OPERATING
PROFIT (LOSS)
|
(4,089
|
)
|
(3,094
|
)
|
(5,642
|
)
|
(3,917
|
)
|
|||||
|
Interest
(expense) income, net
|
(1,243
|
)
|
153
|
(1,716
|
)
|
194
|
|||||||
|
Currency
exchange gains (loss), net
|
(254
|
)
|
(430
|
)
|
(350
|
)
|
(545
|
)
|
|||||
|
Other
income (loss), net
|
16
|
(5
|
)
|
21
|
(6
|
)
|
|||||||
|
INCOME
(LOSS) BEFORE TAXES AND MINORITY INTEREST
|
(5,571
|
)
|
(3,375
|
)
|
(7,686
|
)
|
(4,274
|
)
|
|||||
|
Income
tax (expense) credit
|
140
|
(56
|
)
|
193
|
(70
|
)
|
|||||||
|
NET
INCOME (LOSS)
|
(5,430
|
)
|
(3,431
|
)
|
(7,492
|
)
|
(4,344
|
)
|
|||||
|
Earning
per share - Basic
|
(0.59
|
)
|
(0.39
|
)
|
(0.81
|
)
|
(0.49
|
)
|
|||||
|
Average
number of shares used in computation of EPS
|
9,201
|
8,817
|
9,201
|
8,817
|
|||||||||
|
Earning
per share - Diluted
|
(0.59
|
)
|
(0.39
|
)
|
(0.81
|
)
|
(0.49
|
)
|
|||||
|
Average
number of shares used in computation of EPS for positive net
income
|
9,717
|
9,558
|
9,717
|
9,558
|
|||||||||
NOTE:
Translated for convenience of the reader to U.S. dollars at the 2007 average
twelve months noon buying rate of 1 Euro = 1.3797 USD, and 2006 average
twelve
months noon buying rate of 1 Euro = 1.2661 USD.
EDAP
TMS S.A.
CONSOLIDATED
BALANCE SHEETS HIGHLIGHTS (UNAUDITED)
(Amounts
in thousands of Euros and U.S. Dollars)
|
Dec.
31,
2007
Euros
|
Sept.
30,
2007
Euros
|
Dec.
31,
2007
$US
|
Sept.
30,
2007
$US
|
||||||||||
|
Cash,
cash equivalents and short term investments
|
18,611
|
7,584
|
27,178
|
10,783
|
|||||||||
|
Total
current assets
|
36,123
|
24,730
|
52,065
|
35,164
|
|||||||||
|
Total
current liabilities
|
12,884
|
12,690
|
18,815
|
18,044
|
|||||||||
|
Shareholders’
Equity
|
14,498
|
16,298
|
21,171
|
23,174
|
NOTE:
Translated for convenience of the reader to U.S. dollars at the noon buying
rate
of 1 Euro = 1.4603 USD, on December 31, 2007 and at the noon buying rate
of 1
Euro = 1.4219 USD, on September 30, 2007.
EDAP
TMS S.A.
CONDENSED
STATEMENTS OF OPERATIONS BY DIVISION
TWELVE
MONTHS ENDED DECEMBER 31, 2007
(Amounts
in thousands of Euros)
|
EDAP
S.A.
HIFU
Division
|
TMS
S.A.
UDS
Division
|
EDAP
TMS
HQ
|
FDA
Trials
Division
|
Total
|
||||||||||||
|
Sales
of medical devices
|
2,661
|
6,496
|
9,157
|
|||||||||||||
|
Sales
of spare parts, supplies & services
|
6,610
|
6,446
|
13,056
|
|||||||||||||
|
TOTAL
NET SALES
|
9,271
|
12,943
|
22,213
|
|||||||||||||
|
Other
revenues
|
60
|
53
|
113
|
|||||||||||||
|
TOTAL
REVENUES
|
9,331
|
12,996
|
22,327
|
|||||||||||||
|
GROSS
PROFIT
|
5,391
|
3,788
|
9,179
|
|||||||||||||
|
Research
& Development
|
(1,216
|
)
|
(1,060
|
)
|
(918
|
)
|
(3,194
|
)
|
||||||||
|
Total
SG&A plus depreciation
|
(3,972
|
)
|
(3,352
|
)
|
(1,786
|
)
|
(741
|
)
|
(9,850
|
)
|
||||||
|
Non-recurring
expenses
|
(7
|
)
|
(512
|
)
|
295
|
(224
|
)
|
|||||||||
|
OPERATING
PROFIT (LOSS)
|
204
|
(631
|
)
|
(2,298
|
)
|
(1,363
|
)
|
(4,089
|
)
|
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
:
March 26, 2008
EDAP
TMS
S.A.
/S/
MARC
OCZACHOWSKI
MARC
OCZACHOWSKI
CHIEF
EXECUTIVE OFFICER