Highlights
- Major milestones successfully achieved for Ablatherm-HIFU FDA
PMA process
- Strong lithotripsy sales traction in the US with greater than
twofold sales increase
- Record sales backlog of lithotripsy and HIFU devices entering
2014
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today financial results for the fourth
quarter and year ended December 31, 2013, and provided an update on
recent strategic developments.
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "We
are pleased with the continued progress that our PMA submission has
made over the past year. Just last month, we completed the question
and answer phase with the FDA. We are now advancing towards the FDA
advisory panel meeting."
Mr. Oczachowski continued, "Our 2013 topline results were in
line with the prior year on a constant currency basis and the
year-over-year decrease in our total GAAP revenues was primarily
due to the significant exchange loss of the Euro compared to the
Japanese Yen. We are pleased with the strong traction of our
lithotripsy business in the U.S. with a twofold sales increase in
2013. Starting in 2014, we have a record sales backlog with over
fifteen lithotripters and five HIFU devices, comprised of two Focal
One and three Ablatherms."
Fourth Quarter 2013 Results
Total revenue for the fourth quarter 2013 was EUR 8.1 million
(USD 11.0 million). The current quarter revenue compared to EUR 9.4
million (USD 12.3 million) for the fourth quarter 2012 and a 45%
sequential increase over EUR 5.6 million (USD 7.4 million) for the
third quarter 2013.
Total revenue for the HIFU division was EUR 1.5 million (USD 2.1
million) for the fourth quarter 2013, compared to EUR 2.3 million
(USD 3.0 million) for the same period in 2012. Results for the
fourth quarter 2013 reflected the sale of one Focal One device, as
compared to three HIFU devices sold in the same period last
year.
For the three months ended December 31, 2013, total revenue for
the Lithotripsy division was EUR 6.6 million (USD 8.9 million),
compared to EUR 7.1 million (USD 9.3 million), during the year ago
period. During the fourth quarter 2013, the Company recorded sales
of eighteen lithotripsy machines, comprised of 13 Sonolith i-move
devices and five Sonolith i-sys devices, compared to a total of 21
devices sold in the fourth quarter of 2012.
Gross profit for the fourth quarter 2013 was EUR 3.3 million
(USD 4.4 million), compared to EUR 3.9 million (USD 5.1 million)
for the year ago period. Gross profit margin was 40.2% in the
fourth quarter 2013, compared to 41.3% in the year ago period. The
change in the gross profit margin was mostly attributed to the
negative currency variations against the Euro.
Operating expenses were EUR 3.0 million (USD 4.1 million) for
the fourth quarter 2013, compared to EUR 3.6 million (USD 4.7
million) for the same period 2012. Operating profit was EUR 226,000
(USD 309,000) for the fourth quarter 2013, compared to an operating
profit of EUR 254,000 (USD 331,000) in the fourth quarter of
2012.
Net loss for the fourth quarter 2013 was EUR 570,000 (USD
778,000), or EUR 0.03 per diluted share, compared to net loss for
the fourth quarter of 2012 of EUR 1.1 million (USD 1.4 million), or
EUR 0.06 per diluted share.
Full Year 2013 Results
Total revenue for the full year ended December 31, 2013 was EUR
24.1 million (USD 32.0 million) and EUR 26.0 million on a constant
currency basis, compared to EUR 26.1 million (USD 33.6 million) for
the full year 2012. 2013 revenue included the sales of 45
lithotripsy devices and three HIFU devices.
Gross profit for the full year 2013 was EUR 9.3 million (USD
12.4 million), compared to EUR 10.4 million (USD 13.5 million) for
the full year 2012. Operating loss was EUR 2.8 million (USD 3.7
million), compared to EUR 2.0 million (USD 2.6 million) for the
same period 2012.
Net loss for the full year 2013 was EUR 5.0 (USD 6.7 million),
or EUR 0.24 per diluted share, compared to a full year 2012 net
loss of EUR 7.5 million (USD 9.7 million).
At December 31, 2013, cash and cash equivalents, including
short-term treasury investments, were EUR 7.7 million (USD 10.6
million). The Company's net utilization of cash was EUR 396,000 in
the fourth quarter 2013 and included the EUR 8.5 million net
proceeds from the May 2013 capital increase and the EUR 6.0 million
full repayment in June 2013 of the remaining financial debt.
Conference Call
EDAP will hold a conference call on today, Thursday, April 3,
2014, 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
10040166. 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 event, the webcast will remain available on
EDAP's website, www.edap-tms.com, through May 1, 2014. In addition,
a telephonic replay of the call will be available until April 10,
2014. 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 10040166.
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 statements 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.
|
|
EDAP TMS
S.A. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(Amounts in thousands
of Euros and U.S. Dollars, except per share data) |
|
|
|
|
|
|
Three Months
Ended: |
Three Months
Ended: |
|
December 31,
2013 Euros |
December 31,
2012 Euros |
December 31,
2013 $US |
December 31,
2012 $US |
Sales of medical equipment |
5,552 |
7,200 |
7,583 |
9,397 |
Net Sales of RPP and Leases |
1,033 |
1,058 |
1,411 |
1,380 |
Sales of spare parts, supplies and
Services |
1,492 |
1,121 |
2,038 |
1,463 |
TOTAL NET SALES |
8,076 |
9,378 |
11,032 |
12,240 |
Other revenues |
11 |
45 |
15 |
59 |
TOTAL REVENUES |
8,087 |
9,423 |
11,046 |
12,299 |
Cost of sales |
(4,834) |
(5,534) |
(6,603) |
(7,222) |
|
|
|
|
|
GROSS PROFIT |
3,253 |
3,889 |
4,443 |
5,076 |
Research & development expenses |
(570) |
(673) |
(778) |
(878) |
S, G & A expenses |
(2,457) |
(2,963) |
(3,356) |
(3,867) |
Total operating expenses |
(3,026) |
(3,636) |
(4,134) |
(4,745) |
|
|
|
|
|
OPERATING PROFIT (LOSS) |
226 |
254 |
309 |
331 |
Interest (expense) income, net |
(662) |
(591) |
(905) |
(772) |
Currency exchange gains (loss), net |
(88) |
(735) |
(120) |
(959) |
Other income (loss), net |
(2) |
-- |
(3) |
-- |
|
|
|
|
|
INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(526) |
(1,073) |
(719) |
(1,400) |
Income tax (expense) credit |
(44) |
(26) |
(60) |
(34) |
|
|
|
|
|
NET INCOME (LOSS) |
(570) |
(1,099) |
(778) |
(1,434) |
Earning per share – Basic |
(0.03) |
(0.06) |
(0.04) |
(0.08) |
Average number of shares used in computation
of EPS |
21,789,670 |
18,372,229 |
21,789,670 |
18,372,229 |
Earning per share – Diluted |
(0.03) |
(0.06) |
(0.04) |
(0.08) |
Average number of shares used in computation
of EPS for positive net income |
21,789,670 |
18,372,229 |
21,789,670 |
18,372,229 |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2013 average three months noon buying
rate of 1 Euro = 1.3659 USD, and 2012 average three months noon
buying rate of 1 Euro = 1.3051 USD. |
|
|
|
EDAP TMS
S.A. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(Amounts in
thousands of Euros and U.S. Dollars, except per share
data) |
|
|
|
|
|
|
Twelve Months
Ended: |
Twelve Months
Ended: |
|
December 31,
2013 Euros |
December 31,
2012 Euros |
December 31,
2013 $US |
December 31,
2012 $US |
Sales of medical equipment |
14,767 |
17,009 |
19,645 |
21,959 |
Net Sales of RPP and Leases |
3,922 |
3,988 |
5,218 |
5,148 |
Sales of spare parts, supplies and
Services |
5,375 |
5,021 |
7,151 |
6,482 |
TOTAL NET SALES |
24,065 |
26,018 |
32,014 |
33,589 |
Other revenues |
15 |
47 |
20 |
61 |
TOTAL REVENUES |
24,080 |
26,065 |
32,034 |
33,650 |
Cost of sales |
(14,761) |
(15,632) |
(19,636) |
(20,181) |
|
|
|
|
|
GROSS PROFIT |
9,319 |
10,433 |
12,397 |
13,469 |
Research & development expenses |
(2,595) |
(2,659) |
(3,452) |
(3,432) |
S, G & A expenses |
(9,479) |
(9,805) |
(12,610) |
(12,658) |
Total operating expenses |
(12,074) |
(12,463) |
(16,062) |
(16,090) |
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(2,755) |
(2,030) |
(3,665) |
(2,621) |
Interest (expense) income, net |
(901) |
(4,594) |
(1,198) |
(5,931) |
Currency exchange gains (loss), net |
(1,230) |
(733) |
(1,636) |
(947) |
Other income (loss), net |
-- |
-- |
(1) |
-- |
|
|
|
|
|
INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(4,886) |
(7,358) |
(6,500) |
(9,499) |
Income tax (expense) credit |
(135) |
(118) |
(179) |
(152) |
|
|
|
|
|
NET INCOME (LOSS) |
(5,021) |
(7,475) |
(6,680) |
(9,651) |
Earning per share – Basic |
(0.24) |
(0.43) |
(0.32) |
(0.55) |
Average number of shares used
in computation of EPS |
20,593,720 |
17,556,395 |
20,593,720 |
17,556,395 |
Earning per share – Diluted |
(0.24) |
(0.43) |
(0.32) |
(0.55) |
Average number of shares used in computation
of EPS for positive net income |
20,593,720 |
17,556,395 |
20,593,720 |
17,556,395 |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2013 average twelve months noon
buying rate of 1 Euro = 1.3303 USD, and 2012 average twelve
months noon buying rate of 1 Euro = 1.2910 USD. |
|
|
|
EDAP TMS
S.A. |
CONSOLIDATED BALANCE
SHEETS HIGHLIGHTS |
(Amounts in thousands
of Euros and U.S. Dollars) |
|
|
|
|
|
|
Dec. 31, |
Sept. 30, |
Dec. 31, |
Sept. 30, |
|
2013 |
2013 |
2013 |
2013 |
|
Euros |
Euros |
$US |
$US |
|
|
|
|
|
Cash, cash equivalents and short term
investments |
7,681 |
6,439 |
10,584 |
8,716 |
Total current assets |
22,171 |
20,873 |
30,551 |
28,252 |
Total current liabilities |
11,589 |
10,596 |
15,969 |
14,342 |
Shareholders' Equity |
9,284 |
10,011 |
12,794 |
13,550 |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the noon buying rate of 1 Euro = 1.3780
USD, on December 31, 2013 and at the noon buying rate of 1 Euro =
1.3535 USD, on September 30, 2013. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EDAP TMS
S.A. |
|
|
|
|
|
|
|
|
|
|
CONDENSED
STATEMENTS OF OPERATIONS BY DIVISION |
|
|
|
|
|
|
|
|
|
|
TWELVE
MONTHS ENDED DECEMBER 31, 2013 |
|
|
|
|
|
|
|
|
|
|
(Amounts
in thousands of Euros) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HIFU Division |
|
UDS Division |
|
FDA Trials |
|
Corporate |
|
Total After
Consolidation |
|
Sales of goods |
1,747 |
|
13,020 |
|
|
|
|
|
14,767 |
|
Sales of RPPs & Leases |
2,335 |
|
1,588 |
|
|
|
|
|
3,922 |
|
Sales of spare parts & services |
1,031 |
|
4,344 |
|
|
|
|
|
5,375 |
|
TOTAL NET SALES |
5,113 |
|
18,952 |
|
|
|
|
|
24,065 |
|
|
|
|
|
|
|
|
|
|
|
|
Other revenues |
15 |
|
-- |
|
|
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL REVENUES |
5,128 |
|
18,952 |
|
|
|
|
|
24,080 |
|
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT |
2,638 |
51% |
6,681 |
35% |
|
|
|
|
9,319 |
39% |
|
|
|
|
|
|
|
|
|
|
|
Research & Development |
(1,097) |
|
(525) |
|
(973) |
|
|
|
(2,595) |
|
Total SG&A plus depreciation |
(2,244) |
|
(5,655) |
|
(165) |
|
(1,415) |
|
(9,479) |
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(704) |
|
502 |
|
(1,138) |
|
(1,415) |
|
(2,755) |
|
CONTACT: Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors/Media:
Stephanie Carrington/David Burke/Aaron Estrada
The Ruth Group
646-536-7017/7009/7028
scarrington@theruthgroup.com
dburke@theruthgroup.com
aestrada@theruthgroup.com
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