Second Quarter 2011 Highlights
- Received U.S. FDA 510(k) marketing clearance in August 2011 for
Sonolith i-move device, a technologically advanced compact mobile
lithotripter
- Obtained marketing approval in Japan in June 2011 for Sonolith
i-move
- Drove market demand for renewed lithotripsy product range with
significant lithotripsy backlog with up to fifteen devices
- Advancing Ablatherm-HIFU research initiatives in line with
focal therapy strategy to treat localized prostate cancer
- Cost reduction initiatives progressing well with a 26%
year-over-year operating expense decrease that supports cash
management program
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today financial results for the second
quarter ended June 30, 2011 and provided an update on recent
strategic developments.
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "The
U.S. FDA 510(k) marketing clearance for our Sonolith® i-move
clearly demonstrates EDAP's successful track record of obtaining
FDA approvals. This is very encouraging as we move forward with our
Ablatherm-HIFU clinical trial in the U.S., as we have completed
more than half of the two-year follow-up phase. Our lithotripsy
business is now fully commercialized in the U.S. and EDAP is well
positioned to become a U.S. market leader based on our status as
the only lithotripsy manufacturer with a renewed range of
innovative devices. We showcased our Sonolith i-move at the
American Urological Association medical meeting in May 2011 and
generated several sales leads. With the approval behind us, we are
focused on advancing the sales process that includes holding
upcoming product demonstrations and generating greater awareness
across the U.S. urology community."
Mr. Oczachowski continued, "The second quarter reflected an
unusually low level of activity during the period, as a number of
sales projects shifted into the third quarter. Consequently as we
reach the end of August, we have a very significant device backlog
totaling fifteen lithotripsy devices and one Ablatherm-HIFU device.
We are very excited that a portion of these confirmed purchase
orders are coming from countries where we recently received
marketing approvals for the Sonolith i-move, such as South Korea
and Japan."
Recent Developments
In August 2011, EDAP secured U.S. FDA 510(k) marketing clearance
for its Sonolith i-move device for the fragmentation of kidney
stones, extracorporeal shock wave lithotripsy procedures and
endourology applications. EDAP's established sales force is
cultivating sales leads in the U.S., the second largest lithotripsy
market worldwide.
In August 2011, EDAP's development partnership won a €2.4
million grant for further development of Ablatherm-HIFU technology
to incorporate improved imaging and diagnostic techniques in line
with the focal therapy approach for treating localized prostate
cancer. The development partnership, comprised of EDAP, Edouard
Herriot Hospital, and SuperSonic Imagine, received the highly
competitive French government grant.
In June 2011, EDAP received marketing approval of its Sonolith
i-move lithotripter in Japan. EDAP's experienced direct sales
force, equipped with a full range of innovative devices, is taking
market share in Japan, the largest global lithotripsy market.
Second Quarter 2011 Results
Total revenue for the second quarter 2011 was EUR 3.8 million
(USD 5.5 million), as compared to EUR 6.0 million (USD 7.6 million)
for the second quarter 2010.
Total revenue for the HIFU division was EUR 1.4 million (USD 2.1
million) for the second quarter 2011, compared to 1.9 million (USD
2.4 million) for the same period last year. Results for the second
quarter 2011 reflected the sale of one Ablatherm-HIFU device, as
compared to the sale in the second quarter of 2010 of one
Ablatherm-HIFU machine.
For the three months ended June 30, 2011, total revenue for the
lithotripsy division was EUR 2.4 million (USD 3.4 million),
compared to EUR 4.1 million (USD 5.2 million) during the year ago
period. During the second quarter 2011, the Company recorded sales
of three lithotripsy machines, comprised of three Sonolith i-move
devices, compared to a total of nine devices sold in the second
quarter of 2010.
Gross profit for the second quarter 2011 was EUR 1.5 million
(USD 2.2 million), compared to EUR 2.5 million (USD 3.2 million)
for the year ago period. Gross profit margin was 40.2% in the
second quarter 2011, compared to 41.5% in the year ago period. The
second quarter 2010 gross profit margin was favorably impacted by a
one-time French government grant of EUR 500,000.
Operating expenses were EUR 2.8 million (USD 4.1 million) for
the second quarter 2011, down 26% from EUR 3.8 million (USD 4.7
million) for the same period 2010. Operating loss was EUR 1.3
million (USD 1.8 million) for the second quarter 2011, compared to
EUR 1.3 million (USD 1.6 million) in the second quarter of
2010.
Net loss for the second quarter 2011 was EUR 1.4 million (USD
2.1 million), or EUR 0.11 per diluted share, as compared to net
loss of EUR 1.0 million (USD 1.3 million), or EUR 0.09 per diluted
share, for the second quarter of 2010.
At June 30, 2011, cash and cash equivalents, including
short-term treasury investments, were EUR 5.5 million (USD 8.0
million), which reflected the Company's continued investment in
sales and marketing in support of its robust device pipeline. The
cash utilization during the second quarter 2011 was reduced to EUR
0.5 million as a result of strong cash management.
Conference Call
EDAP will hold a conference call on Tuesday, August 30, 2011 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 10002440. 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 September 30, 2011. In addition,
a telephonic replay of the call will be available until September
7, 2011. The replay dial-in numbers are 877-344-7529 for domestic
callers and 412-317-0088 for international callers. Please use
event passcode 10002440.
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 multi-center U.S. Phase II/III clinical
trial under an Investigational Device Exemption (IDE) granted by
the FDA, the ENLIGHT U.S. clinical study. 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 (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
contains forward-looking statements that involve risks and
uncertainties. These include statements regarding the Company's
growth and expansion plans, the conclusiveness of the results of
and success of its Ablatherm-HIFU clinical trials, expectations
regarding the IDE submission to and approval by the FDA of the
Ablatherm-HIFU device and the market potential for the Sonolith
i-move device. 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 : |
| |
June 30, 2011 Euros |
June 30, 2010
Euros |
June 30, 2011 $US |
June 30, 2010 $US |
| Sales of goods |
1,312 |
2,881 |
1,912 |
3,646 |
| Net Sales of RPP and Leases |
1,160 |
1,296 |
1,691 |
1,640 |
| Sales of spare parts and Services |
1,316 |
1,310 |
1,917 |
1,658 |
| TOTAL NET SALES |
3,788 |
5,487 |
5,520 |
6,943 |
| Other revenues |
3 |
501 |
4 |
634 |
| TOTAL REVENUES |
3,791 |
5,988 |
5,524 |
7,577 |
| Cost of goods |
(806) |
(1,788) |
(1,175) |
(2,263) |
| Cost of RPP and Leases |
(577) |
(688) |
(841) |
(870) |
| Cost of spare parts & services |
(884) |
(1,024) |
(1,288) |
(1,296) |
| Cost of sales |
(2,267) |
(3,500) |
(3,304) |
(4,429) |
| |
|
|
|
|
| GROSS PROFIT |
1,524 |
2,488 |
2,220 |
3,148 |
| Research & development expenses |
(646) |
(1,147) |
(941) |
(1,452) |
| Marketing & Sales expenses |
(1,423) |
(1,763) |
(2,074) |
(2,231) |
| G & A expenses |
(715) |
(843) |
(1,041) |
(1,067) |
| Total operating expenses |
(2,784) |
(3,753) |
(4,056) |
(4,749) |
| |
|
|
|
|
| OPERATING PROFIT (LOSS) |
(1,260) |
(1,265) |
(1,836) |
(1,601) |
| Interest (expense) income, net |
(173) |
174 |
(253) |
221 |
| Currency exchange gains (loss), net |
39 |
832 |
57 |
1,052 |
| Other income (loss), net |
(2) |
(2) |
(2) |
(2) |
| |
|
|
|
|
| INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(1,396) |
(261) |
(2,034) |
(331) |
| Income tax (expense) credit |
(47) |
(756) |
(69) |
(957) |
| |
|
|
|
|
| NET INCOME (LOSS) |
(1,443) |
(1,017) |
(2,103) |
(1,287) |
| Earning per share – Basic |
(0.11) |
(0.09) |
(0.16) |
(0.12) |
| Average number of shares used in
computation of EPS |
13,148,421 |
11,124,274 |
13,148,421 |
11,124,274 |
| Earning per share – Diluted |
(0.11) |
(0.09) |
(0.16) |
(0.12) |
| Average number of shares used in computation
of EPS for positive net income |
13,465,858 |
11,166,193 |
13,465,858 |
11,166,193 |
| |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2011 average three months noon buying
rate of 1 Euro = 1.4573 USD, and 2010 average three months noon
buying rate of 1 Euro = 1.2653 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, 2011 Euros |
June 30, 2010 Euros |
June 30, 2011 $US |
June 30, 2010 $US |
| Sales of goods |
3,736 |
4,641 |
5,318 |
6,112 |
| Net Sales of RPP and Leases |
2,352 |
2,535 |
3,348 |
3,339 |
| Sales of spare parts and Services |
2,537 |
2,644 |
3,612 |
3,482 |
| TOTAL NET SALES |
8,625 |
9,820 |
12,278 |
12,933 |
| Other revenues |
25 |
503 |
36 |
662 |
| TOTAL REVENUES |
8,650 |
10,323 |
12,313 |
13,595 |
| Cost of goods |
(2,259) |
(2,776) |
(3,215) |
(3,655) |
| Cost of RPP and Leases |
(1,210) |
(1,348) |
(1,723) |
(1,775) |
| Cost of spare parts & services |
(1,681) |
(1,996) |
(2,394) |
(2,629) |
| Cost of sales |
(5,151) |
(6,120) |
(7,332) |
(8,060) |
| |
|
|
|
|
| GROSS PROFIT |
3,500 |
4,203 |
4,982 |
5,535 |
| Research & development expenses |
(1,182) |
(1,901) |
(1,683) |
(2,503) |
| Marketing & Sales expenses |
(2,763) |
(3,209) |
(3,933) |
(4,226) |
| G & A expenses |
(1,485) |
(1,743) |
(2,113) |
(2,296) |
| Total operating expenses |
(5,430) |
(6,853) |
(7,729) |
(9,025) |
| |
|
|
|
|
| OPERATING PROFIT (LOSS) |
(1,930) |
(2,650) |
(2,748) |
(3,490) |
| Interest (expense) income, net |
1,194 |
(1,424) |
1,700 |
(1,875) |
| Currency exchange gains (loss), net |
(400) |
1,293 |
(570) |
1,703 |
| Other income (loss), net |
-- |
(2) |
-- |
(3) |
| |
|
|
|
|
| INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(1,136) |
(2,782) |
(1,618) |
(3,664) |
| Income tax (expense) credit |
(94) |
(825) |
(134) |
(1,086) |
| |
|
|
|
|
| NET INCOME (LOSS) |
(1,230) |
(3,607) |
(1,751) |
(4,750) |
| Earning per share – Basic |
(0.09) |
(0.32) |
(0.13) |
(0.43) |
| Average number of shares used in computation
of EPS |
13,148,421 |
11,124,374 |
13,148,421 |
11,124,374 |
| Earning per share – Diluted |
(0.09) |
(0.32) |
(0.13) |
(0.43) |
| Average number of shares used in computation
of EPS for positive net income |
13,591,364 |
11,162,996 |
13,591,364 |
11,162,996 |
| |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2011 average six months noon buying
rate of 1 Euro = 1.4235 USD, and 2010 average six months noon
buying rate of 1 Euro = 1.3170 USD. |
| |
| |
| EDAP TMS
S.A. |
| CONSOLIDATED BALANCE
SHEETS HIGHLIGHTS (UNAUDITED) |
| (Amounts in thousands
of Euros and U.S. Dollars) |
| |
|
|
|
|
| |
June 30, 2011 Euros |
March 31, 2011 Euros |
June 30, 2011 $US |
March 31, 2011 $US |
| |
|
|
|
|
| Cash, cash equivalents and short term
investments |
5,533 |
6,038 |
8,036 |
8,564 |
| Total current assets |
24,990 |
27,590 |
36,291 |
39,129 |
| Total current liabilities |
12,236 |
13,814 |
17,769 |
19,592 |
| Shareholders' Equity |
8,670 |
9,753 |
12,591 |
13,832 |
| |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the noon buying rate of 1 Euro = 1.4522
USD, on June 30, 2011 and at the noon buying rate of 1 Euro =
1.4182 USD, on March 31, 2011. |
| |
| |
| EDAP TMS
S.A. |
| CONDENSED STATEMENTS OF
OPERATIONS BY DIVISION |
| THREE MONTHS ENDED JUNE
30, 2011 |
| (Amounts in thousands
of Euros) |
| |
|
|
|
|
|
|
|
|
| |
HIFU Division |
|
UDS Division |
|
FDA Trials |
Corporate |
Total After
Consolidation |
|
| |
|
|
|
|
|
|
|
|
| Sales of goods |
423 |
|
3,312 |
|
|
|
3,736 |
|
| Sales of RPPs & Leases |
1,700 |
|
652 |
|
|
|
2,352 |
|
| Sales of spare parts & services |
596 |
|
1,942 |
|
|
|
2,537 |
|
| TOTAL NET SALES |
2,719 |
|
5,906 |
|
|
|
8,625 |
|
| |
|
|
|
|
|
|
|
|
| Other revenues |
25 |
|
-- |
|
|
|
25 |
|
| |
|
|
|
|
|
|
|
|
| TOTAL REVENUES |
2,744 |
|
5,906 |
|
|
|
8,650 |
|
| |
|
|
|
|
|
|
|
|
| GROSS PROFIT |
1,470 |
53.6% |
2,029 |
34.4% |
|
|
3,500 |
40.5% |
| |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
| Research & Development |
(446) |
|
(401) |
|
(336) |
|
(1,182) |
|
| Total SG&A plus depreciation |
(1,310) |
|
(2,271) |
|
(35) |
(631) |
(4,248) |
|
| |
|
|
|
|
|
|
|
|
| OPERATING PROFIT (LOSS) |
(285) |
|
(643) |
|
(372) |
(631) |
(1,930) |
|
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
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