2010 Highlights
- U.S. ENLIGHT Ablatherm-HIFU clinical trial completed enrollment
in June 2010 and entered two year follow-up phase
- Lithotripsy division revenues increased 10.2% year-over-year to
EUR 16.8 million (USD 22.2 million), fueled by innovative
lithotripter product line
- Outstanding convertible debt further reduced by USD 6.6 million
to USD 10.5 million at 12/31/10, down from USD 17.1 million at
12/31/09
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, 2010.
Marc Oczachowski, EDAP's Chief Executive Officer, stated,
"During 2010, EDAP achieved a major strategic milestone by
completing patient enrollment in its ENLIGHT Ablatherm-HIFU U.S.
FDA trial. Preliminary patients' follow-up shows satisfactory
outcomes with very low side effects comparable to the European
clinical results obtained over the past fifteen years, and
facilitating the preservation of patients' quality of life. The
final data is yet to be submitted to the U.S. FDA for PMA
review.
"Over the past year, the economic environment has impacted our
HIFU division as hospitals are delaying some capital equipment
expenditures. We remain very encouraged by the growing signals on
the prominent role HIFU is expected to play in the therapeutic
arsenal against prostate cancer. As exemplified by the significant
interest at our booth at the European Association of Urology's
Annual Congress held last week in Vienna, we are seeing an
increasing interest in Ablatherm-HIFU as we position it as the
preferred focal therapy treatment option in line with the prostate
cancer treatment paradigm shift. The international urological
community and patients are demanding a best-in-class device that
combines accurate ablative treatment and quality of life
preservation, and this is the optimal positioning of our
Ablatherm-HIFU solution.
"We are pleased to see return on our investment over the past
few years in our lithotripsy innovation. Our continued growth in
lithotripsy revenues is a clear demonstration that this market
remains very dynamic and in need of technological innovation. EDAP
is the only company in this field to have completely renewed its
range of products and, more importantly to have implemented new
features, concepts and innovation that specifically address the
needs of both patients and urologists. We continue to actively
pursue opportunities to take market share across the global
lithotripsy market and see significant growth potential as we
pursue our regulatory filing strategy in both Japan and the US, the
two largest markets worldwide."
Mr. Oczachowski continued, "Turning to our balance sheet, we are
taking steps to closely manage our cash position. We reduced the
convertible debt outstanding by USD 6.6 million over the past year
and initiated company-wide cost initiatives to position us to reach
timely financial breakeven."
Fourth Quarter 2010 Results
Total revenue for the fourth quarter 2010 was EUR 8.0 million
(USD 10.8 million), as compared to EUR 8.1 million (USD 11.9
million) for the fourth quarter 2009.
Total revenue for the HIFU division was EUR 2.0 million (USD 2.6
million) for the fourth quarter 2010, compared to EUR 3.3 million
(USD 4.8 million) for the same period last year. Results for the
fourth quarter 2010 reflected the sale of two Ablatherm-HIFU
devices, as compared to four Ablatherm-HIFU systems sold in the
fourth quarter of 2009.
For the three months ended December 31, 2010, total revenue for
the lithotripsy division was EUR 6.1 million (USD 8.1 million),
compared to EUR 4.8 million (USD 7.0 million) during the year ago
period. During the fourth quarter 2010, the Company recorded sales
of twenty lithotripsy machines, including seven Sonolith i-sys
devices and five Sonolith i-move devices, up from a total of
fifteen devices sold in the fourth quarter of 2009.
Gross profit for the fourth quarter 2010 was EUR 3.0 million
(USD 4.1 million), compared to EUR 3.7 million (USD 5.4 million)
for the year ago period. Gross profit margin was 37.6% in the
fourth quarter 2010, compared to 45.5% in the year ago period. The
change in the gross profit margin was attributed to shift in the
product mix sold in the fourth quarter of 2010 to a lower
percentage of Ablatherm-HIFU devices.
Operating expenses were EUR 3.4 million (USD 4.6 million) for
the fourth quarter 2010, compared to EUR 3.6 million (USD 5.3
million) for the same period 2009. Fourth quarter 2010 operating
expenses included EUR 265,000 related to the U.S. FDA ENLIGHT
clinical trial for Ablatherm-HIFU, down by 33% on a sequential
quarter basis from EUR 393,000 in the third quarter 2010.
Operating loss was EUR 371,000 (USD 496,000) for the fourth
quarter 2010, and net loss for the fourth quarter 2010 was EUR 7.2
million (USD 9.7 million), or EUR 0.56 per diluted share. The
fourth quarter 2010 net loss included a non-cash interest expense
of EUR 5.5 million (USD 7.3 million) to adjust the Company's
convertible debt and outstanding warrants to fair value, and to
reduce the outstanding convertible debt. Excluding the non-cash
interest expense, the net loss for the fourth quarter 2010 was EUR
1.8 million (USD 2.4 million), or EUR 0.14 per diluted share.
At December 31, 2010, cash and cash equivalents, including
short-term treasury investments, remained strong at EUR 8.9 million
(USD 11.8 million).
Full Year 2010 Results
Total revenue for the full year ended December 31, 2010 was EUR
23.7 million (USD 31.3 million), as compared to EUR 24.9 million
(USD 34.7 million) for full year 2009. Full Year revenues were
mostly impacted by the lower Ablatherm-HIFU machines sales in 2010
with four devices sold, as compared to seven systems sold in 2009,
a revenue shift that could not be fully offset by the 10.2%
increase in lithotripsy revenues.
For the full year 2010, gross profit was EUR 9.5 million (USD
12.5 million) and operating loss was EUR 3.9 million (USD 5.0
million), compared to EUR 10.7 million (USD 14.9 million) and EUR
3.2 million (USD 4.5 million), respectively, for the same period
2009. The revenue shift was reflected in the lower gross profit,
but was partially offset by reductions in operating expenses, which
were EUR 13.3 million (USD 17.5 million) for the full year 2010,
compared to EUR 13.9 million (USD 19.4 million) for the same period
2009.
Net loss for the full year 2010 was EUR 12.7 million (USD 16.8
million), or EUR 0.98 per diluted share. The full year 2010 net
loss included a non-cash interest expense of EUR 6.1 million (USD
8.0 million) to adjust the Company's convertible debt and
outstanding warrants to fair value, and to reduce the outstanding
convertible debt. Excluding the non-cash interest expense, the net
loss for the full year 2010 was EUR 6.7 million (USD 8.8 million),
or EUR 0.51 per diluted share.
Mr. Oczachowski concluded, "We continue to advance our strategic
initiatives to expand our market penetration. Recent milestones
achieved include implementing cost reductions, receiving temporary
reimbursement in France, entering new markets with our
state-of-the-art lithotripsy product range, expanding our HIFU
business in key regions and moving forward our approval processes
in various major countries."
Conference Call
EDAP will hold a conference call on Tuesday, March 29, 2011 at
8:30 a.m. EDT to discuss the results. The dial-in numbers are (877)
407-4134 for domestic callers and (201) 689-8430 for international.
The conference ID number for both is 368595. 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 April 29, 2011. In addition, a
telephonic replay of the call will be available until April 5,
2011. The replay dial-in numbers are 877-660-6853 for domestic
callers and 201-612-7415 for international callers. Please use
account number 356 and event ID number 368595.
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 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 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 and expectations
regarding the IDE submission to and approval by the FDA of the
Ablatherm-HIFU 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: |
|
December 31,
2010 Euros |
December 31,
2009 Euros |
December 31,
2010 $US |
December 31,
2009 $US |
Sales of medical equipment |
5,671 |
5,137 |
7,599 |
7,547 |
Net Sales of RPP and Leases |
1,064 |
1,436 |
1,426 |
2,110 |
Sales of spare parts, supplies and
Services |
1,302 |
1,503 |
1,745 |
2,209 |
TOTAL NET SALES |
8,037 |
8,076 |
10,769 |
11,866 |
Other revenues |
1 |
3 |
1 |
5 |
TOTAL REVENUES |
8,038 |
8,080 |
10,770 |
11,871 |
Cost of sales |
(5,013) |
(4,405) |
(6,717) |
(6,472) |
|
|
|
|
|
GROSS PROFIT |
3,025 |
3,675 |
4,053 |
5,399 |
Research & development expenses(1) |
(675) |
(688) |
(904) |
(1,012) |
S, G & A expenses |
(2,721) |
(2,888) |
(3,646) |
(4,243) |
Total operating expenses |
(3,396) |
(3,576) |
(4,550) |
(5,254) |
|
|
|
|
|
OPERATING PROFIT (LOSS)
(1) |
(371) |
98 |
(496) |
145 |
Interest (expense) income, net |
(6,851) |
1,433 |
(9,180) |
2,105 |
Currency exchange gains (loss), net |
81 |
155 |
109 |
228 |
Other income (loss), net |
2 |
-- |
3 |
-- |
|
|
|
|
|
INCOME (LOSS) BEFORE
TAXES(1) AND MINORITY INTEREST |
(7,139) |
1,686 |
(9,565) |
2,477 |
Income tax (expense) credit(1) |
(86) |
(57) |
(115) |
(84) |
|
|
|
|
|
NET INCOME (LOSS) |
(7,224) |
1,629 |
(9,680) |
2,393 |
Earning per share – Basic |
(0.56) |
0.15 |
(0.74) |
0.23 |
|
|
|
|
|
Average number of shares used in computation
of EPS |
13,008,401 |
10,510,305 |
13,008,401 |
10,510,305 |
Earning per share – Diluted |
(0.56) |
0.15 |
(0.74) |
0.23 |
Average number of shares used in computation
of EPS for positive net income |
13,496,394 |
10,545,730 |
13,496,394 |
10,545,730 |
|
NOTE: Translated
for convenience of the reader to U.S. dollars at the 2010 average
three months noon buying rate of 1 Euro = 1.3399 USD, and 2009
average three months noon buying rate of 1 Euro = 1.4693 USD. |
(1) Certain prior year amounts
have been reclassified to conform to the current year's
presentation |
|
|
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,
2010 Euros |
December 31,
2009 Euros |
December 31,
2010 $US |
December 31,
2009 $US |
Sales of medical equipment |
13,135 |
13,775 |
17,358 |
19,223 |
Net Sales of RPP and Leases |
4,689 |
5,444 |
6,197 |
7,597 |
Sales of spare parts, supplies and
Services |
5,378 |
5,620 |
7,107 |
7,843 |
TOTAL NET SALES |
23,202 |
24,839 |
30,662 |
34,663 |
Other revenues |
506 |
46 |
669 |
64 |
TOTAL REVENUES |
23,708 |
24,885 |
31,331 |
34,727 |
Cost of sales |
(14,253) |
(14,213) |
(18,836) |
(19,834) |
|
|
|
|
|
GROSS PROFIT |
9,455 |
10,672 |
12,495 |
14,893 |
Research & development expenses(1) |
(3,268) |
(3,651) |
(4,318) |
(5,095) |
S, G & A expenses |
(10,005) |
(10,223) |
(13,222) |
(14,265) |
Total operating expenses |
(13,272) |
(13,874) |
(17,540) |
(19,361) |
|
|
|
|
|
OPERATING PROFIT (LOSS)
(1) |
(3,818) |
(3,202) |
(5,045) |
(4,468) |
Interest (expense) income, net |
(8,844) |
(4,390) |
(11,688) |
(6,127) |
Currency exchange gains (loss), net |
884 |
(101) |
1,168 |
(142) |
Other income (loss), net |
-- |
-- |
-- |
-- |
|
|
|
|
|
INCOME (LOSS) BEFORE
TAXES(1) AND MINORITY INTEREST |
(11,778) |
(7,694) |
(15,565) |
(10,736) |
Income tax (expense) credit(1) |
(939) |
(72) |
(1,241) |
(101) |
|
|
|
|
|
NET INCOME (LOSS) |
(12,717) |
(7,766) |
(16,806) |
(10,837) |
Earning per share – Basic |
(0.98) |
(0.74) |
(1.29) |
(1.03) |
|
|
|
|
|
Average number of shares used
in computation of EPS |
13,008,401 |
10,510,305 |
13,008,401 |
10,510,305 |
Earning per share – Diluted |
(0.98) |
(0.74) |
(1.29) |
(1.03) |
Average number of shares used in computation
of EPS for positive net income |
13,094,235 |
10,567,563 |
13,094,235 |
10,567,563 |
|
|
|
|
|
NOTE: Translated
for convenience of the reader to U.S. dollars at the 2010 average
twelve months noon buying rate of 1 Euro = 1.3215 USD, and
2009 average twelve months noon buying rate of 1 Euro = 1.3955
USD. |
(1) Certain prior year amounts
have been reclassified to conform to the current year's
presentation. |
|
|
EDAP TMS
S.A. |
CONSOLIDATED BALANCE
SHEETS HIGHLIGHTS (UNAUDITED) |
(Amounts in thousands
of Euros and U.S. Dollars) |
|
|
Dec. 31,
2010 Euros |
Sept. 30,
2010 Euros |
Dec. 31,
2010 $US |
Sept. 30,
2010 $US |
Cash, cash equivalents and short term
investments |
8,888 |
8,012 |
11,794 |
10,898 |
Total current assets |
29,868 |
29,085 |
39,634 |
38,922 |
Total current liabilities |
14,658 |
13,730 |
19,451 |
18,675 |
Shareholders' Equity |
8,900 |
9,540 |
11,809 |
12,976 |
|
|
|
|
|
NOTE: Translated
for convenience of the reader to U.S. dollars at the noon buying
rate of 1 Euro = 1.3270 USD, on December 31, 2010 and at the noon
buying rate of 1 Euro = 1.3602 USD, on September 30, 2010. |
|
|
|
|
EDAP TMS
S.A. |
|
CONDENSED STATEMENTS OF
OPERATIONS BY DIVISION |
|
TWELVE MONTHS ENDED
DECEMBER 31, 2010 |
|
(Amounts in thousands
of Euros) |
|
|
|
|
|
|
|
|
|
|
|
HIFU Division |
|
UDS Division |
|
FDA Trials |
Corporate |
Total After
Consolidation |
Sales of goods |
1,940 |
|
11,196 |
|
|
|
|
|
Sales of RPPs & Leases |
3,505 |
|
1,184 |
|
|
|
4,689 |
|
Sales of spare parts & services |
1,438 |
|
3,940 |
|
|
|
5,378 |
|
TOTAL NET SALES |
6,882 |
|
16,319 |
|
|
|
23,202 |
|
|
|
|
|
|
|
|
|
|
Other revenues |
6 |
|
500 |
|
|
|
506 |
|
|
|
|
|
|
|
|
|
|
TOTAL REVENUES |
6,888 |
|
16,820 |
|
|
|
23,708 |
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT |
3,604 |
52% |
5,851 |
35% |
|
|
9,455 |
40% |
|
|
|
|
|
|
|
|
|
Research & Development |
(741) |
|
(793) |
|
(1,734) |
|
(3,268) |
|
Total SG&A plus depreciation |
(3,506) |
|
(4,968) |
|
(193) |
(1,338) |
(10,005) |
|
|
|
|
|
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(644) |
|
91 |
|
(1,927) |
(1,338) |
(3,818) |
|
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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