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 [ ]
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
[ ] 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, June 30, June 30, June 30,
2008 2007 2008 2007
Euros Euros $US $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 728 (880) 1,137 (1,192)
AND MINORITY INTEREST
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 9,276,459 9,543,569 9,276,459 9,543,569
used in computation of
EPS for positive net
income
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, June 30, June 30, June 30,
2008 2007 2008 2007
Euros Euros $US $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 4,352
Services 2,816 2,830 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 9,200,757 9,163,007 9,200,757 9,163,007
used in computation of
EPS
Earning per share - Diluted 0.22 (0.21) 0.34 (0.28)
Average number of shares 9,276,459 9,685,022 9,276,459 9,685,022
used in computation of
EPS for positive net
income
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, Mar. 31, June 30, Mar. 31,
2008 2008 2008 2008
Euros Euros $US $US
Cash, cash equivalents and 13,406 15,542 21,112 24,565
short term investments
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)
Total
HIFU UDS FDA Corporate After
Division Division Trials Consoli-
dation
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)
Contact:
EDAP TMS SA
Contact:
Blandine Confort, Investor Relations/Legal Affairs
+33 4 72 15 31 72
bconfort@edap-tms.com
The Ruth Group
Investors:
R.J. Pellegrino
646-536-7009
rpellegrino@theruthgroup.com
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