Third Quarter Highlights
- Revenues increased 15.5% year-over-year to EUR 5.3 million (USD
7.0 million)
- Gross margin rose 500 basis points over last year to 41.6%
- Operating loss, excluding lower FDA clinical trial expense,
improved by EUR 576,000 to EUR 404,000
- Net loss improved by EUR 3.9 million to EUR 1.9 million
- Inventory expanded for year-end sales opportunities; strong,
growing machine backlog
- Initiated robust cost initiatives to drive timely financial
breakeven
LYON, France, Nov. 17, 2010 (GLOBE NEWSWIRE) -- EDAP
TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound,
announced today financial results for the third quarter ended
September 30, 2010.
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "We
are optimistic about the continuing development and traction of our
Ablatherm-HIFU treatment for localized prostate cancer and other
new oncology indications. A tremendous opportunity exists to
position HIFU as the optimum treatment option for focal
therapy. We are pleased with the advancement of the focal
therapy trials underway in France and the high level of interest
that urologists are expressing in this therapy.
"During the third quarter, we invested in augmenting our device
inventory to be positioned to take advantage of fourth quarter
sales opportunities in both Ablatherm-HIFU and lithotripsy. We
currently have thirteen lithotripsy and two Ablatherm machines in
our backlog and a strong pipeline that we expect to convert to
backlog by the end of the year. This sales activity is in line
with the medical device sales seasonality as hospitals deploy
capital expenditures budgets late in the year."
Mr. Oczachowski continued, "We achieved several major milestones
across both of our product lines. We expect to aggressively
pursue all of these opportunities as we expand our sales and
advance our clinical programs. At the same time, we understand
the necessity of bringing the Company to financial breakeven and
have implemented some initiatives to accelerate the alignment of
operational costs to meet this important metric.
"The long-term data for localized prostate cancer that was
published in September further validated the clinical experience
that has been achieved across Europe over the past fifteen
years. At the same time, we are pursuing earlier stage
opportunities to expand the oncology applications of our HIFU
technology through the research collaborations for HIFU ablating
metastatic liver cancer and for combining HIFU with ultrasound
sensitive liposomes to activate the targeted delivery of cancer
drugs."
Recent Strategic Milestones and Initiatives
- HIFU for potential treatment of metastatic liver
cancer: The first phase of the clinical protocol
aimed at evaluating High Intensity Focused Ultrasound (HIFU)
technology in patients with metastatic liver cancer was
successfully completed. Clinical results observed fully conformed
with those obtained in pre-clinical studies and validated HIFU as
being an additional potential option to address liver cancer.
- Expansion of sales force to address large Japanese
market for lithotripsy: EDAP strengthened its
lithotripsy sales force in Japan to address one of the largest
markets for the treatment of urinary stones. Earlier this
year, EDAP received Japanese marketing approval for its fully
integrated and robotized Sonolith i-sys lithotripsy device.
- HIFU for potential improvement of cancer drug
delivery: Feasibility studies aimed at improving
delivery of cancer drugs using a combination of ultrasound
sensitive liposomes and High Intensity Focused Ultrasound (HIFU)
were successfully completed.
- Favorable long-term HIFU data for treatment of
localized prostate cancer: In September 2010, EDAP
reported on a study of 803 patients with localized prostate cancer,
treated with Ablatherm-HIFU from 1993 until 2007. This study,
carried out by Dr. Sebastien Crouzet, Urologist at Edouard Herriot
Hospital in Lyon, France, demonstrated the durability of efficacy
outcomes of robotic Ablatherm-HIFU in the treatment of localized
prostate cancer.
- Entry into fast growing China market: EDAP
entered into an exclusive distribution agreement with Shaw Han
Biomedical Co. Ltd to obtain approval of EDAP's Ablatherm-HIFU
device for the treatment of prostate cancer and distribute the
devices in China.
Third Quarter Results
Total revenue for the third quarter 2010 were EUR 5.3 million
(USD 7.0 million), an increase of 15.5% as compared to EUR 4.6
million (USD 6.7 million) for the third quarter 2009.
Total revenue for the HIFU division was EUR 1.4 million (USD 1.9
million) for the third quarter 2010, compared to EUR 2.1 million
(USD 3.0 million) for the same period last year. Results for the
third quarter 2010 reflected increased net sales of spare parts and
services.
For the three months ended September 30, 2010, total revenue for
the lithotripsy division was EUR 3.9 million (USD 5.2 million),
compared to EUR 2.5 million (USD 3.6 million) during the year ago
period. During the third quarter 2010, the Company recorded sales
of ten lithotripsy machines, including three Sonolith i-sys devices
and four Sonolith i-move devices.
Gross profit for the third quarter 2010 was EUR 2.2 million (USD
2.9 million), compared to EUR 1.7 million (USD 2.4 million) for the
year ago period. Gross profit margin was 41.6% in the third quarter
2010, compared to 36.7% in the year ago period.
Operating expenses were EUR 3.0 million (USD 4.0 million) for
the third quarter 2010, compared to EUR 3.2 million (USD 4.6
million) for the same period 2009. Third quarter 2010 operating
expenses included EUR 393,000 related to the U.S. FDA ENLIGHT
clinical trial for Ablatherm-HIFU, down by 42% on a sequential
quarter basis from EUR 674,000 in the second quarter 2010.
Operating loss was EUR 797,000 (USD 1.0 million) for the third
quarter 2010, compared to EUR 1.5 million (USD 2.2 million) for the
year ago period. Excluding U.S. FDA trial expenses, third quarter
2010 operating loss was EUR 404,000.
Net loss for the third quarter 2010 was EUR 1.9 million (USD 2.5
million), or EUR 0.17 per diluted share, compared to a net loss of
EUR 5.8 million (USD 8.3 million), or EUR 0.55 per diluted share,
in the year ago period. The third quarter 2010 net loss included a
non-cash interest expense of EUR 0.2 million (USD 0.3 million) to
adjust the Company's convertible debt and outstanding warrants to
fair value, compared to a EUR 4.0 million (USD 5.7 million)
non-cash expense during the prior year period.
At September 30, 2010, cash and cash equivalents, including
short-term treasury investments, were EUR 8.0 million (USD 10.9
million). The Company deployed its cash during the third
quarter 2010 to replenish its device inventories.
Conference Call
EDAP will hold a conference call on Wednesday, November 17, 2010
at 8:30 a.m. EST 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 359599. 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 December 17, 2010. In addition,
a telephonic replay of the call will be available until November
24, 2010. 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 359599.
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: |
|
September 30, |
September 30, |
September 30, |
September 30, |
|
2010 |
2009 |
2010 |
2009 |
|
Euros |
Euros |
$US |
$US |
Sales of goods |
2,823 |
2,100 |
3,706 |
3,030 |
Net Sales of RPP and Leases |
1,090 |
1,160 |
1,431 |
1,675 |
Sales of spare parts and services |
1,432 |
1,365 |
1,879 |
1,970 |
TOTAL NET SALES |
5,345 |
4,625 |
7,015 |
6,674 |
Other revenues |
3 |
3 |
3 |
4 |
TOTAL REVENUES |
5,348 |
4,628 |
7,019 |
6,678 |
Cost of goods |
(1,502) |
(1,420) |
(1,971) |
(2,049) |
Cost of RPP and Leases |
(583) |
(558) |
(765) |
(805) |
Cost of spare parts and services |
(1,036) |
(953) |
(1,360) |
(1,376) |
Cost of sales |
(3,121) |
(2,931) |
(4,096) |
(4,230) |
GROSS PROFIT |
2,227 |
1,697 |
2,923 |
2,448 |
Research & development expenses |
(692) |
(964) |
(909) |
(1,392) |
Marketing & Sales expenses |
(1,500) |
(1,304) |
(1,969) |
(1,882) |
G & A expenses |
(832) |
(939) |
(1,091) |
(1,355) |
Total operating expenses |
(3,024) |
(3,208) |
(3,969) |
(4,629) |
OPERATING PROFIT (LOSS) |
(797) |
(1,511) |
(1,046) |
(2,181) |
Interest (expense) income, net |
(569) |
(4,362) |
(747) |
(6,295) |
Currency exchange gains (loss), net |
(491) |
57 |
(644) |
82 |
Other income (loss), net |
-- |
1 |
-- |
1 |
INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(1,857) |
(5,816) |
(2,438) |
(8,395) |
Income tax (expense) credit |
(29) |
48 |
(38) |
69 |
NET INCOME (LOSS) |
(1,886) |
(5,768) |
(2,476) |
(8,326) |
|
|
|
|
|
Earning per share – Basic |
(0.17) |
(0.55) |
(0.22) |
(0.80) |
Average number of shares used
in computation of EPS |
11,284,837 |
10,413,985 |
11,284,837 |
10,413,985 |
Earning per share – Diluted |
(0.17) |
(0.55) |
(0.22) |
(0.80) |
Average number of shares used
in computation of EPS for positive net income |
11,320,262 |
10,467,966 |
11,320,262 |
10,467,966 |
|
|
|
|
|
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2010 average three months noon buying
rate of 1 Euro = 1.3125 USD, and 2009 average three months noon
buying rate of 1 Euro = 1.4430 USD. |
|
|
EDAP TMS
S.A. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED) |
(Amounts in thousands
of Euros and U.S. Dollars, except per share data) |
|
|
Nine Months
Ended: |
Nine Months
Ended: |
|
|
September 30, |
September 30, |
September 30, |
September 30, |
|
|
2010 |
2009 |
2010 |
2009 |
|
|
Euros |
Euros |
$US |
$US |
|
|
|
|
|
|
|
Sales of goods |
7,464 |
8,638 |
9,818 |
11,834 |
|
Net Sales of RPP and Leases |
3,625 |
4,008 |
4,768 |
5,490 |
|
Sales of spare parts and services |
4,076 |
4,177 |
5,361 |
5,640 |
|
TOTAL NET SALES |
15,165 |
16,763 |
19,948 |
22,963 |
|
Other revenues |
506 |
42 |
665 |
58 |
|
TOTAL REVENUES |
15,670 |
16,805 |
20,614 |
23,021 |
|
Cost of goods |
(4,277) |
(5,079) |
(5,627) |
(6,958) |
|
Cost of RPP and Leases |
(1,931) |
(2,008) |
(2,540) |
(2,751) |
|
Cost of spare parts and services |
(3,032) |
(2,721) |
(3,989) |
(3,727) |
|
Cost of sales |
(9,241) |
(9,808) |
(12,156) |
(13,436) |
|
|
|
|
|
|
|
GROSS PROFIT |
6,430 |
6,997 |
8,458 |
9,586 |
|
Research & development expenses |
(2,593) |
(2,963) |
(3,411) |
(4,059) |
|
Marketing & Sales expenses |
(4,709) |
(4,391) |
(6,194) |
(6,015) |
|
G & A expenses |
(2,575) |
(2,944) |
(3,387) |
(4,033) |
|
|
|
|
|
|
|
Total operating expenses |
(9,877) |
(10,298) |
(12,992) |
(14,107) |
|
OPERATING PROFIT (LOSS) |
(3,447) |
(3,300) |
(4,534) |
(4,521) |
|
Interest (expense) income, net |
(1,993) |
(5,823) |
(2,622) |
(7,976) |
|
Currency exchange gains (loss), net |
803 |
(256) |
1,056 |
(351) |
|
Other income (loss), net |
(2) |
-- |
(2) |
-- |
|
|
|
|
|
|
|
INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(4,639) |
(9,379) |
(6,103) |
(12,852) |
|
Income tax (expense) credit |
(854) |
(15) |
(1,123) |
(21) |
|
NET INCOME (LOSS) |
(5,493) |
(9,395) |
(7,226) |
(12,872) |
|
|
|
|
|
|
|
Earning per share – Basic |
(0.49) |
(0.90) |
(0.64) |
(1.24) |
|
Average number of shares used
in computation of EPS |
11,284,837 |
10,413,985 |
11,284,837 |
10,413,985 |
|
Earning per share – Diluted |
(0.49) |
(0.90) |
(0.64) |
(1.24) |
|
Average number of shares used
in computation of EPS for positive net income |
11,355,075 |
10,422,816 |
11,355,075 |
10,422,816 |
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2010 average nine months noon buying
rate of 1 Euro = 1.3154 USD, and 2009 average nine months noon
buying rate of 1 Euro = 1.3699 USD. |
|
|
|
EDAP TMS
S.A. |
CONSOLIDATED BALANCE
SHEETS HIGHLIGHTS (UNAUDITED) |
(Amounts in thousands
of Euros and U.S. Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sept. 30, |
June 30, |
Sept. 30, |
June 30, |
|
2010 |
2010 |
2010 |
2010 |
|
Euros |
Euros |
$US |
$US |
|
|
|
|
|
Cash, cash equivalents and short term
investments |
8,012 |
11,380 |
10,898 |
13,987 |
Total current assets |
29,085 |
32,564 |
38,922 |
39,447 |
Total current liabilities |
13,730 |
15,244 |
18,675 |
18,737 |
Shareholders' Equity |
9,540 |
10,431 |
12,976 |
12,821 |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the noon buying rate of 1 Euro = 1.3602
USD, on September 30, 2010 and at the noon buying rate of 1
Euro = 1.2291 USD, on June 30, 2010. |
|
|
EDAP TMS
S.A. |
CONDENSED STATEMENTS OF
OPERATIONS BY DIVISION |
NINE MONTHS ENDED
SEPTEMBER 30, 2010 |
(Amounts in thousands
of Euros) |
|
|
|
|
|
|
|
|
|
|
|
Total After |
|
HIFU Division |
UDS Division |
FDA Trials |
Corporate |
Consolidation |
|
|
|
|
|
|
Sales of goods |
1,104 |
6,360 |
|
|
7,464 |
Sales of RPPs and Leases |
2,728 |
897 |
|
|
3,625 |
Sales of spare parts and services |
1,080 |
2,995 |
|
|
4,076 |
TOTAL NET SALES |
4,912 |
10,253 |
|
|
15,165 |
|
|
|
|
|
|
Other revenues |
5 |
500 |
|
|
506 |
|
|
|
|
|
|
TOTAL REVENUES |
4,917 |
10,753 |
|
|
15,670 |
GROSS PROFIT |
2,672 |
3,758 |
|
|
6,430 |
(as a % of Net Sales) |
54.4% |
36.6% |
|
|
42.4% |
|
|
|
|
|
|
|
|
|
|
|
|
Research & Development |
(461) |
(619) |
(1,512) |
|
(2,593) |
Total SG&A plus depreciation |
(2,586) |
(3,498) |
(149) |
(1,051) |
(7,284) |
|
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(375) |
(359) |
(1,661) |
(1,051) |
(3,447) |
CONTACT: EDAP TMS SA
Investor Relations / Legal Affairs
Blandine Confort
+33 4 72 15 31 72
bconfort@edap-tms.com
The Ruth Group
Investors:
Stephanie Carrington
646-536-7017
scarrington@theruthgroup.com
EDAP TMS (NASDAQ:EDAP)
Historical Stock Chart
From Jun 2024 to Jul 2024
EDAP TMS (NASDAQ:EDAP)
Historical Stock Chart
From Jul 2023 to Jul 2024