- Received CE mark for innovative robotic HIFU device Focal
One®
- Eliminated all outstanding long-term debt and strengthened
financial profile
- Publication of long-term study reporting 10 year
cancer-specific survival and metastatic-free survival rates for
prostate cancer patients treated with Ablatherm-HIFU
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today financial results for the second
quarter and six months ended June 30, 2013, and provided an update
on recent strategic developments.
Marc Oczachowski, EDAP's Chief Executive Officer, stated,
"During the quarter, we continued to make strides in our business
plan as we strengthened our balance sheet and reached a significant
milestone with our innovative technology. In particular, we repaid
the full $8 million of our outstanding long-term debt. We also
received CE mark in June for Focal One®, our additional and
complementary robotic HIFU device, and we have subsequently
commenced our commercialization efforts in Europe. In addition,
device sales are progressing well as we reach the end of August,
with several pending lithotripsy projects that we anticipated
closing during the second quarter confirmed in early July due to
customer related factors. We continue to strengthen our sales
backlog and are working toward closing these in the coming
weeks."
Recent Developments
In June 2013, EDAP received CE mark (European regulatory
approval) for Focal One®, its new and innovative robotic HIFU
device fully dedicated to focal therapy of prostate cancer. The CE
mark positions Focal One for commercialization in Europe and in
many other countries.
In June 2013, EDAP completed the full redemption of its $8.0
million outstanding long-term debt by using a portion of the net
proceeds from the $12.0 million private placement executed in May
2013.
In June 2013, the 100-day meeting with the FDA provided a
discussion forum regarding the PMA application for EDAP's
Ablatherm-HIFU device for the treatment of localized prostate
cancer and confirmed that our submission process is ongoing.
In May 2013, new long-term data demonstrating high rates of both
cancer-specific and overall survival of 1,002 patients treated with
high-intensity focused ultrasound (HIFU) was electronically
published in European Urology, the official journal of the European
Association of Urology. The prospective, single-arm,
single-institution cohort study, led by Drs. Sebastien Crouzet and
Albert Gelet of Edouard Herriot Hospital, evaluated the morbidity
and long-term oncologic outcomes of primary HIFU therapy for
localized prostate cancer. The study is the Company's third peer
reviewed publication this year reporting 10 year cancer-specific
survival and metastatic-free survival rates following
Ablatherm-HIFU treatment.
Second Quarter 2013 Results
Total revenue for the second quarter 2013 was EUR 4.5 million
(USD 5.9 million), compared to EUR 6.1 million (USD 7.8 million)
for the second quarter 2012.
Total revenue for the HIFU division was EUR 967,000 (USD 1.3
million) for the second quarter 2013, compared to EUR 1.1 million
(USD 1.4 million) for the same period last year. Results for the
second quarter 2013 included the sales of RPP's and sales of spare
parts and services.
For the three months ended June 30, 2013, total revenue for the
lithotripsy division was EUR 3.5 million (USD 4.6 million),
compared to EUR 5.0 million (USD 6.4 million), during the year ago
period. During the second quarter 2013, the Company recorded sales
of eight lithotripsy machines, comprised of five Sonolith i-move
devices and three Sonolith Praktis devices, compared to a total of
fourteen devices sold in the second quarter of 2012.
Gross profit for the second quarter 2013 was EUR 1.6 million
(USD 2.1 million), compared to EUR 2.4 million (USD 3.1 million)
for the year ago period. Gross profit margin was 36.1% in the
second quarter 2013, compared to 39.1% in the year ago period. The
change in the gross profit margin was mostly attributed to the
negative impact of the Japanese Yen exchange rate variations
against the Euro.
Operating expenses were EUR 3.1 million (USD 4.0 million) for
the second quarter 2013, compared to EUR 3.3 million (USD 4.2
million) for the same period 2012. Operating loss was EUR 1.5
million (USD 1.9 million) for the second quarter 2013, compared to
an operating loss of EUR 937,000 (USD 1.2 million) in the second
quarter of 2012.
Net loss for the second quarter 2013 was EUR 195,000 (USD
255,000), or EUR 0.01 per diluted share, as compared to net loss
for the second quarter 2012 of EUR 3.0 million (USD 3.8 million),
or EUR 0.16 per diluted share. Net loss for the second quarter 2013
included interest income of EUR 1.9 million as a result of non-cash
accounting adjustments related to the full redemption of the
Company's long-term debt and to fair value variations of the
Company's outstanding warrants.
First Six Months 2013 Results
Total revenue for the first half of 2013 was EUR 10.4 million
(USD 13.7 million), including a negative impact of EUR 800,000 due
to currency exchange rate variations, down 4.9% compared to EUR
11.0 million (USD 14.3 million) for the first half of 2012.
Excluding the impact of exchange rate variations, total revenues
would have experienced moderate growth of 2% for the period.
Gross profit for the first half of 2013 was EUR 3.8 million (USD
5.0 million) and gross profit margin was 36.7% and 39.5% on a
like-for-like basis after adjusting for the currency exchange
variations, compared to 39.2% in the year ago period.
Operating loss for the first half of 2013 was EUR 2.6 million
(USD 3.5 million) and net loss for the first half of 2013 was EUR
4.1 million (USD 5.3 million), or EUR 0.21 per diluted share, as
compared to net loss of EUR 5.9 million (USD 7.6 million), or EUR
0.32 per diluted share, in the first half of 2012. Net loss for the
first six months of 2013 included a non-cash interest expense of
EUR 0.4 million (USD 0.5 million) to reflect the full redemption of
the Company's long-term financial debt and accounting fair value
adjustments on its outstanding warrants.
At June 30, 2013, cash and cash equivalents, including
short-term treasury investments, were EUR 7.4 million (USD 9.6
million). The Company's net cash position was stable in the second
quarter 2013.
Conference Call
EDAP will hold a conference call on Wednesday, August 28, 2013
at 8:30 a.m. EDT to discuss the results. The dial-in numbers are
1-877-300-8521 for domestic callers and 1-412-317-6026 for
international callers. The conference ID number for both is
10032218. 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 25, 2013. In addition,
a telephonic replay of the call will be available until September
4, 2013. The replay dial-in numbers are 1-877-870-5176 for domestic
callers and 1-858-384-5517 for international callers. Please use
event passcode 10032218.
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® 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, Ablatherm-HIFU is approved and
commercialized in Europe as a treatment for prostate cancer and is
currently under regulatory review in the U.S. following submission
of the Pre-Market Approval Application in February 2013 after the
completion of a multi-center U.S. Phase II/III clinical trial under
an Investigational Device Exemption (IDE) granted by the FDA. The
Company also develops its HIFU 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 may
contain forward-looking statements that involve risks and
uncertainties. 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, 2013
Euros |
June 30, 2012
Euros |
June 30, 2013
$US |
June 30, 2012
$US |
Sales of goods |
2,251 |
3,747 |
2,939 |
4,779 |
Net Sales of RPP and Leases |
1,037 |
1,088 |
1,353 |
1,388 |
Sales of spare parts and Services |
1,211 |
1,290 |
1,581 |
1,646 |
TOTAL NET SALES |
4,499 |
6,126 |
5,873 |
7,813 |
Other revenues |
3 |
-- |
4 |
-- |
TOTAL REVENUES |
4,502 |
6,126 |
5,877 |
7,813 |
Cost of goods |
(1,369) |
(2,200) |
(1,788) |
(2,806) |
Cost of RPP and Leases |
(599) |
(608) |
(782) |
(775) |
Cost of spare parts & services |
(906) |
(925) |
(1,183) |
(1,179) |
Cost of sales |
(2,875) |
(3,732) |
(3,753) |
(4,760) |
|
|
|
|
|
GROSS PROFIT |
1,627 |
2,394 |
2,124 |
3,053 |
Research & development expenses |
(646) |
(854) |
(843) |
(1,090) |
Marketing & Sales expenses |
(1,560) |
(1,536) |
(2,036) |
(1,959) |
G & A expenses |
(880) |
(940) |
(1,149) |
(1,199) |
Total operating expenses |
(3,086) |
(3,331) |
(4,028) |
(4,248) |
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(1,458) |
(937) |
(1,904) |
(1,195) |
Interest (expense) income, net |
1,817 |
(2,386) |
2,372 |
(3,043) |
Currency exchange gains (loss), net |
(545) |
257 |
(712) |
328 |
Other income (loss), net |
2 |
33 |
3 |
42 |
|
|
|
|
|
INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(184) |
(3,032) |
(240) |
(3,868) |
Income tax (expense) credit |
(12) |
49 |
(15) |
62 |
|
|
|
|
|
NET INCOME (LOSS) |
(195) |
(2,984) |
(255) |
(3,806) |
Earning per share – Basic |
(0.01) |
(0.16) |
(0.01) |
(0.21) |
Average number of shares used in computation
of Basic EPS |
19,923,003 |
18,257,273 |
19,923,003 |
18,257,273 |
Earning per share – Diluted |
(0.01) |
(0.16) |
(0.01) |
(0.21) |
Average number of shares used in computation
of Diluted EPS |
19,923,003 |
18,257,273 |
19,923,003 |
18,257,273 |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2013 average three months noon buying
rate of 1 Euro = 1.3055 USD, and 2012 average three months noon
buying rate of 1 Euro = 1.2753 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, 2013
Euros |
June 30, 2012 Euros |
June 30, 2013
$US |
June 30, 2012 $US |
Sales of goods |
5,944 |
6,212 |
7,792 |
8,076 |
Net Sales of RPP and Leases |
1,970 |
2,201 |
2,582 |
2,862 |
Sales of spare parts and Services |
2,512 |
2,550 |
3,293 |
3,316 |
TOTAL NET SALES |
10,426 |
10,963 |
13,667 |
14,253 |
Other revenues |
3 |
-- |
4 |
-- |
TOTAL REVENUES |
10,429 |
10,963 |
13,671 |
14,253 |
Cost of goods |
(3,612) |
(3,575) |
(4,735) |
(4,648) |
Cost of RPP and Leases |
(1,122) |
(1,243) |
(1,471) |
(1,615) |
Cost of spare parts & services |
(1,870) |
(1,850) |
(2,451) |
(2,405) |
Cost of sales |
(6,604) |
(6,667) |
(8,657) |
(8,668) |
|
|
|
|
|
GROSS PROFIT |
3,825 |
4,296 |
5,014 |
5,585 |
Research & development expenses |
(1,578) |
(1,563) |
(2,069) |
(2,032) |
Marketing & Sales expenses |
(3,094) |
(2,959) |
(4,055) |
(3,846) |
G & A expenses |
(1,802) |
(1,718) |
(2,362) |
(2,233) |
Total operating expenses |
(6,474) |
(6,239) |
(8,486) |
(8,111) |
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(2,649) |
(1,943) |
(3,472) |
(2,526) |
Interest (expense) income, net |
(612) |
(3,941) |
(803) |
(5,124) |
Currency exchange gains (loss), net |
(757) |
(11) |
(992) |
(14) |
Other income (loss), net |
1 |
40 |
1 |
51 |
|
|
|
|
|
INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(4,017) |
(5,855) |
(5,266) |
(7,613) |
Income tax (expense) credit |
(61) |
(25) |
(80) |
(33) |
|
|
|
|
|
NET INCOME (LOSS) |
(4,078) |
(5,880) |
(5,346) |
(7,645) |
Earning per share – Basic |
(0.21) |
(0.32) |
(0.28) |
(0.42) |
Average number of shares used in computation
of Basic EPS |
19,321,827 |
18,257,273 |
19,321,827 |
18,257,273 |
Earning per share – Diluted |
(0.21) |
(0.32) |
(0.28) |
(0.42) |
Average number of shares used in computation
of Diluted EPS |
19,321,827 |
18,257,273 |
19,321,827 |
18,257,273 |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2013 average six months noon buying
rate of 1 Euro = 1.3108 USD, and 2012 average six months noon
buying rate of 1 Euro = 1. 3001 USD. |
|
|
|
EDAP TMS S.A.
CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (UNAUDITED)
(Amounts in thousands of Euros and U.S.
Dollars) |
|
|
|
|
|
|
June
30, 2013 Euros |
March 31,
2013 Euros |
June 30,
2013 $US |
March 31,
2013 $US |
|
|
|
|
|
Cash, cash equivalents and short term
investments |
7,373 |
7,288 |
9,592 |
9,340 |
Total current assets |
21,470 |
22,249 |
27,933 |
28,513 |
Total current liabilities |
10,902 |
12,292 |
14,184 |
15,753 |
Shareholders' Equity |
9,907 |
4,190 |
12,890 |
5,369 |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the noon buying rate of 1 Euro = 1.3011
USD, on June 30, 2013 and at the noon buying rate of 1 Euro =
1.2816 USD, on March 31, 2013. |
|
|
|
EDAP TMS S.A.
CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
SIX MONTHS ENDED JUNE 30, 2013 (Amounts in
thousands of Euros) |
|
|
|
|
|
|
|
HIFU Division |
UDS Division |
FDA Trials |
Corporate |
Total After
Consolidation |
|
|
|
|
|
|
Sales of goods |
650 |
5,294 |
|
|
5,944 |
Sales of RPPs & Leases |
1,203 |
766 |
|
|
1,970 |
Sales of spare parts & services |
495 |
2,017 |
|
|
2,512 |
TOTAL NET SALES |
2,349 |
8,077 |
|
|
10,426 |
|
|
|
|
|
|
Other revenues |
3 |
-- |
|
|
3 |
|
|
|
|
|
|
TOTAL REVENUES |
2,352 |
8,077 |
|
|
10,429 |
|
|
|
|
|
|
GROSS PROFIT |
1,203 |
2,623 |
|
|
3,825 |
|
|
|
|
|
|
Research & Development |
(571) |
(362) |
(645) |
|
(1,578) |
Total SG&A plus depreciation |
(1,146) |
(2,915) |
(74) |
(761) |
(4,896) |
|
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(514) |
(654) |
(719) |
(761) |
(2,649) |
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/David Burke
646-536-7017/7009
scarrington@theruthgroup.com
dburke@theruthgroup.com
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