EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today financial results for the third quarter
ended September 30, 2013.
Recent Highlights
- Total third quarter 2013 revenue of EUR 5.6 million, sequential
quarterly growth of 24%
- Strong device backlog entering fourth quarter 2013
- Focal One® delivered in October 2013 and first treatments
performed in Europe
- Ablatherm-HIFU highlighted in presentations at the 31st World
Congress of Endourology
Marc Oczachowski, EDAP's Chief Executive Officer, commented,
"During the third quarter, we continued to execute our business
plan by generating revenue from sales of our commercialized
devices. As expected, we closed several orders that were secured
during the second quarter. Entering the fourth quarter, we have a
strong device backlog of 14 Lithotripters and the entire EDAP team
worldwide is focusing on closing deals before year end as this is
the most active time of our seasonal business.
"Importantly, we recently delivered our first Focal One® device
to a customer in Europe. The delivery and installation was
completed as scheduled and the first treatments were successfully
performed. We are pleased with the reception of this device in the
early stages of our marketing efforts and we are excited about the
potential opportunity of Focal One®."
Third Quarter 2013 Results
Total revenue for the third quarter 2013 was EUR 5.6 million
(USD 7.4 million), compared to EUR 5.7 million (USD 7.1 million)
for the third quarter 2012.
Total revenue for the lithotripsy division was EUR 4.3 million
(USD 5.8 million) for the three months ended September 30, 2013, as
compared to EUR 4.8 million (USD 6.0 million) for the year ago
period. During the third quarter 2013, the Company recorded sales
of nine lithotripsy machines, compared to a total of 12 devices
sold in the third quarter of 2012.
Total revenue for the HIFU division was EUR 1.2 million (USD 1.7
million) for the third quarter 2013, compared to EUR 0.9 million
(USD 1.1 million) for the same period last year. The Company
recorded the sale of one Ablatherm-HIFU device during the third
quarter of 2013.
Gross profit for the third quarter 2013 was EUR 2.2 million (USD
3.0 million), compared to EUR 2.2 million (USD 2.8 million) for the
year ago period. Gross profit margin was 40.3% in the third quarter
2013, compared to 39.6% in the year ago period.
Operating expenses were EUR 2.6 million (USD 3.4 million) for
the third quarter 2013, compared to EUR 2.6 million (USD 3.3
million) for the same period in 2012. Operating loss was EUR
333,000 (USD 444,000) for the third quarter 2013, compared to EUR
341,000 (USD 429,000) in the third quarter of 2012.
Net loss for the third quarter 2013 was EUR 373,000 (USD
497,000), or EUR 0.02 per diluted share (USD 0.02 per diluted
share), as compared to net loss for the third quarter 2012 of EUR
496,000 (USD 624,000), or EUR 0.03 per diluted share (USD 0.03 per
diluted share).
First Nine Months 2013 Results
Total revenue for the first nine months of 2013 was EUR 16.0
million (USD 21.1 million), and EUR 17.1 million on a constant
currency basis compared to EUR 16.6 million (USD 21.4 million) in
the first nine months of 2012.
Gross profit for the first nine months of 2013 was EUR 6.1
million (USD 8.0 million), compared to EUR 6.5 million (USD 8.4
million) for the first nine months of 2012. Gross profit margin was
37.9% in the first nine months of 2013, and 40.6% on a constant
currency basis compared to 39.3% in the first nine months of
2012.
Operating loss for the first nine months of 2013 was EUR 3.0
million (USD 3.9 million), compared to EUR 2.3 million (USD 2.9
million) for the same period of 2012.
Net loss for the first nine months of 2013 was EUR 4.5 million
(USD 5.9 million), or EUR 0.22 per diluted share (USD 0.29 per
diluted share), as compared to net loss of EUR 6.4 million (USD 8.2
million), or EUR 0.37 per diluted share (USD 0.48 per diluted
share), in the first nine months of 2012. Net loss for the first
nine months of 2013 included a EUR 1.1 million (USD 1.5 million)
currency exchange loss.
At September 30, 2013, cash and cash equivalents, including
short-term treasury investments, were EUR 6.4 million (USD 8.7
million). The Company's net cash utilization was EUR 0.9 million in
the third quarter 2013 and included EUR 1.4 million of inventory
replenishment in preparation for the fourth quarter 2013 sales
activity.
Conference Call
EDAP will hold a conference call today, Thursday, November 21,
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
10035894. 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 19, 2013. In addition,
a telephonic replay of the call will be available until November
28, 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 10035894.
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.
In February 2013, the Company introduced a new innovative HIFU
device, the Focal One® dedicated to focal therapy of prostate
cancer. Focal One® is CE marked but is not FDA approved. 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.. Such statements00 are based on
management's current expectations and are subject to a number of
risks and uncertainties, including matters not yet known to us or
not currently considered material by us, and there can be no
assurance that anticipated events will occur or that the objectives
set out will actually be achieved. Important factors that could
cause actual results to differ materially from the results
anticipated in the forward-looking statements include, among others
the uncertainties of the U.S. FDA approval process, the clinical
status and market acceptance of our HIFU devices and the
continued market potential for our lithotripsy device.,. Factors
that may cause such a difference also may 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.
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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, |
|
2013 |
2012 |
2013 |
2012 |
|
Euros |
Euros |
$US |
$US |
Sales of goods |
3,271 |
3,597 |
4,363 |
4,527 |
Net Sales of RPP and Leases |
920 |
729 |
1,226 |
917 |
Sales of spare parts and Services |
1,371 |
1,350 |
1,829 |
1,699 |
TOTAL NET SALES |
5,562 |
5,676 |
7,418 |
7,143 |
Other revenues |
1 |
2 |
2 |
3 |
TOTAL REVENUES |
5,563 |
5,678 |
7,420 |
7,145 |
Cost of goods |
(1,938) |
(2,083) |
(2,584) |
(2,621) |
Cost of RPP and Leases |
(514) |
(533) |
(686) |
(670) |
Cost of spare parts & services |
(870) |
(816) |
(1,161) |
(1,026) |
Cost of sales |
(3,322) |
(3,431) |
(4,431) |
(4,317) |
|
|
|
|
|
GROSS PROFIT |
2,241 |
2,248 |
2,989 |
2,828 |
Research & development expenses |
(447) |
(423) |
(596) |
(532) |
Marketing & Sales expenses |
(1,302) |
(1,296) |
(1,737) |
(1,631) |
G & A expenses |
(825) |
(869) |
(1,100) |
(1,094) |
Total operating expenses |
(2,574) |
(2,588) |
(3,432) |
(3,257) |
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(333) |
(341) |
(444) |
(429) |
Interest (expense) income, net |
373 |
(63) |
498 |
(79) |
Currency exchange gains (loss), net |
(385) |
12 |
(514) |
16 |
Other income (loss), net |
3 |
(37) |
3 |
(48) |
|
|
|
|
|
INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(343) |
(429) |
(457) |
(540) |
Income tax (expense) credit |
(30) |
(67) |
(40) |
(84) |
|
|
|
|
|
NET INCOME (LOSS) |
(373) |
(496) |
(497) |
(624) |
Earning per share – Basic |
(0.02) |
(0.03) |
(0.02) |
(0.03) |
|
|
|
|
|
Average number of shares used
in computation of EPS |
21,789,670 |
18,257,273 |
21,789,670 |
18,257,273 |
|
|
|
|
|
Earning per share – Diluted |
(0.02) |
(0.03) |
(0.02) |
(0.03) |
|
|
|
|
|
Average number of shares used
in computation of EPS for positive net income |
21,789,670 |
18,257,273 |
21,789,670 |
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 = 1.3337 USD, and 2012 average
three months noon buying rate of 1 Euro = 1.2583 USD. |
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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, |
|
2013 |
2012 |
2013 |
2012 |
|
Euros |
Euros |
$US |
$US |
Sales of goods |
9,216 |
9,809 |
12,150 |
12,616 |
Net Sales of RPP and Leases |
2,889 |
2,930 |
3,809 |
3,769 |
Sales of spare parts and Services |
3,883 |
3,901 |
5,120 |
5,017 |
TOTAL NET SALES |
15,988 |
16,640 |
21,079 |
21,402 |
Other revenues |
4 |
2 |
5 |
3 |
TOTAL REVENUES |
15,993 |
16,642 |
21,085 |
21,404 |
Cost of goods |
(5,550) |
(5,678) |
(7,317) |
(7,302) |
Cost of RPP and Leases |
(1,636) |
(1,775) |
(2,157) |
(2,283) |
Cost of spare parts & services |
(2,740) |
(2,645) |
(3,613) |
(3,402) |
Cost of sales |
(9,926) |
(10,098) |
(13,087) |
(12,988) |
|
|
|
|
|
GROSS PROFIT |
6,066 |
6,544 |
7,998 |
8,416 |
Research & development expenses |
(2,025) |
(1,986) |
(2,670) |
(2,554) |
Marketing & Sales expenses |
(4,396) |
(4,255) |
(5,795) |
(5,472) |
G & A expenses |
(2,627) |
(2,587) |
(3,463) |
(3,327) |
Total operating expenses |
(9,048) |
(8,828) |
(11,929) |
(11,354) |
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(2,982) |
(2,284) |
(3,931) |
(2,938) |
Interest (expense) income, net |
(239) |
(4,004) |
(315) |
(5,150) |
Currency exchange gains (loss), net |
(1,142) |
2 |
(1,506) |
2 |
Other income (loss), net |
3 |
2 |
4 |
2 |
|
|
|
|
|
INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(4,360) |
(6,285) |
(5,748) |
(8,084) |
Income tax (expense) credit |
(91) |
(92) |
(120) |
(118) |
|
|
|
|
|
NET INCOME (LOSS) |
(4,451) |
(6,377) |
(5,869) |
(8,202) |
Earning per share – Basic |
(0.22) |
(0.37) |
(0.29) |
(0.48) |
|
|
|
|
|
Average number of shares used
in computation of EPS |
20,169,756 |
17,248,329 |
20,169,756 |
17,248,329 |
|
|
|
|
|
Earning per share – Diluted |
(0.22) |
(0.37) |
(0.29) |
(0.48) |
|
|
|
|
|
Average number of shares used
in computation of EPS for positive net income |
20,169,756 |
17,248,329 |
20,169,756 |
17,248,329 |
|
|
|
|
|
NOTE: Translated for
convenience of the reader to U.S. dollars at the 2013 average nine
months noon buying rate of 1 Euro = 1.3184 USD, and 2012 average
nine months noon buying rate of 1 Euro = 1.2862 USD. |
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|
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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, |
|
2013 |
2013 |
2013 |
2013 |
|
Euros |
Euros |
$US |
$US |
|
|
|
|
|
Cash, cash equivalents and short term
investments |
6,439 |
7,373 |
8,716 |
9,592 |
Total current assets |
20,873 |
21,470 |
28,252 |
27,933 |
Total current liabilities |
10,596 |
10,902 |
14,342 |
14,184 |
Shareholders' Equity |
10,011 |
9,907 |
13,550 |
12,890 |
|
|
|
|
|
NOTE: Translated for
convenience of the reader to U.S. dollars at the noon buying rate
of 1 Euro = 1.3535 USD, on September 30, 2013 and at the noon
buying rate of 1 Euro = 1.3011USD, on June 30, 2013. |
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|
|
|
|
|
|
|
EDAP TMS
S.A. |
CONDENSED STATEMENTS OF
OPERATIONS BY DIVISION |
NINE MONTHS ENDED
SEPTEMBER 30, 2013 |
(Amounts in thousands
of Euros) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total After |
|
|
HIFU Division |
|
UDS Division |
|
FDA Trials |
Corporate |
Consolidation |
|
Sales of goods |
1,103 |
|
8,112 |
|
|
|
9,216 |
|
Sales of RPPs & Leases |
1,737 |
|
1,152 |
|
|
|
2,889 |
|
Sales of spare parts & services |
748 |
|
3,136 |
|
|
|
3,883 |
|
TOTAL NET SALES |
3,588 |
|
12,400 |
|
|
|
15,988 |
|
|
|
|
|
|
|
|
|
|
Other revenues |
4 |
|
-- |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
TOTAL REVENUES |
3,592 |
|
12,400 |
|
|
|
15,993 |
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT |
1,893 |
52.7% |
4,173 |
33.7% |
|
|
6,066 |
37.9% |
|
|
|
|
|
|
|
|
|
Research & Development |
(696) |
|
(493) |
|
(836) |
|
(2,025) |
|
Total SG&A plus depreciation |
(1,647) |
|
(4,113) |
|
(116) |
(1,146) |
(7,023) |
|
|
|
|
|
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(450) |
|
(433) |
|
(952) |
(1,146) |
(2,982) |
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CONTACT: Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors:
Stephanie Carrington /David Burke
The Ruth Group
646-536-7017/7009
scarrington@theruthgroup.com
dburke@theruthgroup.com
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