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, 2016, and provided an update
on strategic and operational accomplishments.
Marc Oczachowski, EDAP’s Chief Executive Officer,
stated, “EDAP has made steady progress in the first half of the
year. The FDA clearance of Ablatherm Robotic HIFU in late 2015 has
resulted in strong system sales, while the growth in treatment
driven revenues continued as a result of the traction and momentum
of HIFU globally.”
“The solid performance of the HIFU division, in
which revenues increased 69% over the first half of 2015, is clear
evidence that our market penetration strategy is working and
supports the expansion and growth of our global HIFU business. We
continue penetrating the U.S. market with our strategy of targeting
large and recognized institutions directly, while also providing
access to the entire urology community by partnering with
mobilizers and service providers.
In April, we submitted a 510(k) application for our
next generation Focal One® HIFU system with the FDA. We are closely
working on the file through direct interaction with the
agency.”
Mr. Oczachowski added, “We are pleased with our
business development during the first half of 2016, and with the
great traction we are achieving in our HIFU division with a
significant increase in our project pipeline, particularly in the
U.S. Thanks to this continued growth, the company generated an
operating profit for the first half of the year and has a solid
cash position that makes EDAP well-funded to further drive its
growth and expansion initiatives.”
Second Quarter 2016 Results
Total revenue for the second quarter 2016
was EUR 8.2 million (USD 9.2 million), a 4.6%
year-over-year increase compared to EUR 7.8 million (USD
8.7 million) for the second quarter 2015.
Total revenue in the HIFU business for this quarter
was EUR 3.4 million (USD 3.8 million) compared to EUR 2.3
million (USD 2.6 million) for the second quarter 2015. HIFU
revenue included the sale of three Ablatherm systems and one Focal
One.
For the three months ended June 30, 2016, total
revenue for the Lithotripsy division was EUR 4.8 million (USD 5.4
million), compared to EUR 5.5 million (USD 6.1 million), during the
year ago period.
Gross profit for the second quarter 2016 was EUR
3.5 million (USD 3.9 million), compared to EUR 3.3 million (USD 3.7
million) for the year ago period. Gross profit margin on net sales
was 42.3% in the second quarter of 2016, compared to 42.5% in the
year ago period.
Operating expenses were EUR 3.8 million (USD 4.3
million) for the second quarter 2016, compared to EUR 3.6 million
(USD 3.9 million) for the same period in 2015.
Operating loss for the second quarter 2016 was EUR
0.3 million (USD 0.4 million), compared with EUR 0.2 million (USD
0.2 million) in the second quarter of 2015.
Net income for the second quarter 2016 was EUR 2.5
million (USD 2.8 million), or EUR 0.08 per diluted share, as
compared to net income of EUR 0.5 million (USD 0.5 million), or EUR
0.02 per diluted share, in the year ago period. Net income in the
second quarter of 2016 included non-cash interest income of EUR 2.4
million to adjust the accounting fair value of the outstanding
warrants.
First Six Months 2016 Results
Total revenue for the first half of 2016
was EUR 16.9 million (USD 18.9 million), up 20.4%
compared to EUR 14.1 million (USD 15.6 million) for the
first half of 2015.
Total revenue in the HIFU division for the first
six months 2016 was EUR 6.7 million (USD 7.4 million) compared to
EUR 3.9 million (USD 4.4 million) for the six months ended
June 30, 2015. HIFU revenue included the sale of six Ablatherm
systems and two Focal One.
For the six months ended June 30, 2016, total
revenue for the Lithotripsy division was EUR 10.2 million (USD 11.4
million), compared to EUR 10.1 million (USD 11.2 million), during
the year ago period.
Gross profit for the first half of 2016
was EUR 7.8 million (USD 8.6 million) and gross profit
margin was 45.8%, compared to 42.1% in the year ago period.
Operating expenses were EUR 7.4 million (USD 8.2
million) for the first six months of 2016, compared to EUR 6.8
million (USD 7.5 million) for the same period in 2015.
The Company recorded an operating profit the first
half of 2016 of EUR 0.4 million (USD 0.4 million),
compared with an operating loss of EUR 0.8 million (USD 0.9
million) in the first six months of 2015.
Net income for the first half of 2016 was EUR
3.9 million (USD 4.3 million), or EUR 0.13 per
diluted share, as compared to a net loss of EUR 2.0
million (USD 2.2 million), or EUR 0.08 per diluted share,
in the first half of 2015. Net income in the first half of 2016
included a non-cash interest income of EUR 2.9 million to
adjust the accounting fair value of the outstanding warrants.
At June 30, 2016, cash and cash equivalents,
including short-term treasury investments, were EUR 21.9
million (USD 24.2 million).
Conference Call EDAP will hold a
conference call on Thursday, August 25th, 2016 at 8:30 a.m. EDT to
discuss the results and provide an update on recent business
developments. The dial-in numbers are 1-888-348-6419 in the U.S.,
and 1-412-902-4235 for international callers. The conference
ID number for both is 10091258. 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 September
27, 2016. In addition, a dial-in replay of the call will be
available. 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 10091258.
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for
high-intensity focused ultrasound (HIFU) for prostate tissue
ablation in the U.S. and for treatment of localized
prostate cancer in the rest of the world. HIFU treatment is shown
to be a minimally invasive and effective option for prostatic
tissue ablation 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 for commercial
distribution in Europe and some other countries including
Mexico and Canada, and has received 510(k) clearance by
the U.S. FDA. The Company also markets an innovative
robot-assisted 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 distributes medical
equipment (the Sonolith® lithotripters' range) for the treatment of
urinary tract stones using extra-corporeal shockwave lithotripsy
(ESWL) in most countries including Canada and
the U.S. 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 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.
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, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
|
Euros |
|
|
Euros |
|
|
$US |
|
|
$US |
|
Sales of goods |
|
5,262 |
|
|
5,357 |
|
|
5,896 |
|
|
5,948 |
|
Net Sales of RPP and
Leases |
|
1,316 |
|
|
1,090 |
|
|
1,474 |
|
|
1,210 |
|
Sales of spare parts
and |
|
|
|
|
|
|
|
|
|
|
|
|
Services |
|
1,611 |
|
|
1,388 |
|
|
1,805 |
|
|
1,541 |
|
TOTAL NET
SALES |
|
8,189 |
|
|
7,834 |
|
|
9,174 |
|
|
8,699 |
|
Other revenues |
|
8 |
|
|
2 |
|
|
9 |
|
|
2 |
|
TOTAL
REVENUES |
|
8,197 |
|
|
7,836 |
|
|
9,183 |
|
|
8,701 |
|
Cost of goods |
|
(2,768 |
) |
|
(2,996 |
) |
|
(3,101 |
) |
|
(3,327 |
) |
Cost of RPP and
Leases |
|
(805 |
) |
|
(648 |
) |
|
(902 |
) |
|
(720 |
) |
Cost of spare parts
& services |
|
(1,162 |
) |
|
(861 |
) |
|
(1,302 |
) |
|
(956 |
) |
Cost of sales |
|
(4,736 |
) |
|
(4,505 |
) |
|
(5,305 |
) |
|
(5,002 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS
PROFIT |
|
3,461 |
|
|
3,331 |
|
|
3,878 |
|
|
3,699 |
|
Research &
development expenses |
|
(887 |
) |
|
(739 |
) |
|
(993 |
) |
|
(820 |
) |
Marketing & Sales
expenses |
|
(2,147 |
) |
|
(1,859 |
) |
|
(2,406 |
) |
|
(2,064 |
) |
G & A
expenses |
|
(772 |
) |
|
(950 |
) |
|
(865 |
) |
|
(1,055 |
) |
Total operating
expenses |
|
(3,806 |
) |
|
(3,548 |
) |
|
(4,264 |
) |
|
(3,940 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
PROFIT (LOSS) |
|
(345 |
) |
|
(217 |
) |
|
(386 |
) |
|
(241 |
) |
Interest (expense)
income, net |
|
2,412 |
|
|
1,005 |
|
|
2,702 |
|
|
1,116 |
|
Currency exchange gains
(loss), net |
|
483 |
|
|
(262 |
) |
|
541 |
|
|
(291 |
) |
Other income (loss),
net |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCOME (LOSS)
BEFORE TAXES AND MINORITY INTEREST |
|
2,550 |
|
|
526 |
|
|
2,857 |
|
|
584 |
|
Income tax (expense)
credit |
|
(52 |
) |
|
(39 |
) |
|
(58 |
) |
|
(43 |
) |
|
NET INCOME
(LOSS) |
|
2,498 |
|
|
487 |
|
|
2,799 |
|
|
541 |
|
Earning per share –
Basic |
|
0.09 |
|
|
0.02 |
|
|
0.109 |
|
|
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average number of
shares used in computation of Basic EPS |
|
28,288,307 |
|
|
24,958,174 |
|
|
28,288,307 |
|
|
24,958,174 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earning per share –
Diluted |
|
0.08 |
|
|
0.02 |
|
|
0.09 |
|
|
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average number of
shares used in computation of Diluted EPS |
|
29,826,117 |
|
|
27,016,460 |
|
|
29,826,117 |
|
|
27,016,460 |
|
|
|
|
|
|
|
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2016 average three months’ noon
buying rate of 1 Euro =1.1203 USD, and 2015 average three months’
noon buying rate of 1 Euro = 1.1104 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, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
|
Euros |
|
|
Euros |
|
|
$US |
|
|
$US |
|
Sales of goods |
|
11,261 |
|
|
9,103 |
|
|
12,518 |
|
|
10,095 |
|
Net Sales of RPP and
Leases |
|
2,578 |
|
|
2,119 |
|
|
2,865 |
|
2,350 |
Sales of spare parts
and |
|
|
|
|
|
|
|
|
|
|
|
|
Services |
|
3,078 |
|
|
2,830 |
|
|
3,421 |
|
|
3,138 |
|
TOTAL NET
SALES |
|
16,917 |
|
|
14,052 |
|
|
18,805 |
|
|
15,584 |
|
Other revenues |
|
8 |
|
|
2 |
|
|
9 |
|
|
2 |
|
TOTAL
REVENUES |
|
16,925 |
|
|
14,054 |
|
|
18,814 |
|
|
15,586 |
|
Cost of goods |
|
(5,561 |
) |
|
(5,042 |
) |
|
(6,182 |
) |
|
(5,591 |
) |
Cost of RPP and
Leases |
|
(1,513 |
) |
|
(1,292 |
) |
|
(1,681 |
) |
|
(1,433 |
) |
Cost of spare parts
& services |
|
(2,097 |
) |
|
(1,809 |
) |
|
(2,332 |
) |
|
(2,006 |
) |
Cost of sales |
|
(9,171 |
) |
|
(8,143 |
) |
|
(10,195 |
) |
|
(9,030 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS
PROFIT |
|
7,753 |
|
|
5,911 |
|
|
8,619 |
|
|
6,556 |
|
Research &
development expenses |
|
(1,701 |
) |
|
(1,512 |
) |
|
(1,890 |
) |
|
(1,677 |
) |
Marketing & Sales
expenses |
|
(4,013 |
) |
|
(3,408 |
) |
|
(4,460 |
) |
|
(3,780 |
) |
G & A
expenses |
|
(1,652 |
) |
|
(1,830 |
) |
|
(1,836 |
) |
|
(2,030 |
) |
Total operating
expenses |
|
(7,365 |
) |
|
(6,750 |
) |
|
(8,187 |
) |
|
(7,486 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
PROFIT (LOSS) |
|
388 |
|
|
(839 |
) |
|
432 |
|
|
(931 |
) |
Interest (expense)
income, net |
|
2,891 |
|
|
(1,344 |
) |
|
3,213 |
|
|
(1,491 |
) |
Currency exchange gains
(loss), net |
|
671 |
|
|
303 |
|
|
746 |
|
|
336 |
|
Other income (loss),
net |
|
- |
|
|
(3 |
) |
|
- |
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
INCOME (LOSS)
BEFORE TAXES AND MINORITY INTEREST |
|
3,950 |
|
|
(1,884 |
) |
|
4,391 |
|
|
(2,089 |
) |
Income tax (expense)
credit |
|
(91 |
) |
|
(69 |
) |
|
(101 |
) |
|
(77 |
) |
|
NET INCOME
(LOSS) |
|
3,859 |
|
|
(1,953 |
) |
|
4,289 |
|
|
(2,166 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Earning per share –
Basic |
|
0.14 |
|
|
(0.08 |
) |
|
0.16 |
|
|
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Average number of
shares used in computation of Basic EPS |
|
26,844,696 |
|
|
24,926,627 |
|
|
26,844,696 |
|
|
24,926,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earning per share –
Diluted |
|
0.13 |
|
|
(0.08 |
) |
|
0.15 |
|
|
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Average number of
shares used in computation of Diluted EPS |
|
28,615,172 |
|
|
24,926,627 |
|
|
28,615,172 |
|
|
24,926,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2016 average six months’ noon buying
rate of 1 Euro =1.1116 USD, and 2015 average six months’ noon
buying rate of 1 Euro = 1. 1090 USD. |
EDAP TMS S.A. |
|
CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (Amounts
in thousands of Euros and U.S. Dollars) |
|
|
|
|
June 30, |
|
Mar.
31, |
|
June 30, |
|
Mar.
31, |
|
|
|
2016 |
|
2016 |
|
2016 |
|
2016 |
|
|
|
Euros |
|
Euros |
|
$US |
|
$US |
|
|
Cash, cash equivalents
and short term investments |
|
21,940 |
|
14,533 |
|
24,203 |
|
16,552 |
|
Total current
assets |
|
40,963 |
|
33,019 |
|
45,188 |
|
37,607 |
|
Total current
liabilities |
|
14,817 |
|
16,529 |
|
16,345 |
|
18,826 |
|
Shareholders’
Equity |
|
24,358 |
|
15,901 |
|
26,870 |
|
18,111 |
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1031
USD, on June 30, 2016and at the noon buying rate of 1 Euro = 1.1390
USD, on March 31, 2016. |
|
EDAP TMS S.A. |
|
|
CONDENSED STATEMENTS OF OPERATIONS BY
DIVISION |
|
SIX MONTHS ENDED JUNE 30, 2016 |
|
(Amounts in thousands of Euros) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HIFU
Division |
|
|
UDS
Division |
|
FDA
Trials |
|
|
Corporate |
|
|
|
Total AfterConsolidation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales of goods |
4,536 |
|
|
|
|
6,725 |
|
|
|
|
|
|
|
|
|
|
11,261 |
|
|
|
|
Sales of RPPs &
Leases |
1,811 |
|
|
|
|
766 |
|
|
|
|
|
|
|
|
|
|
2,578 |
|
|
|
|
Sales of spare parts
& services |
328 |
|
|
|
|
2,750 |
|
|
|
|
|
|
|
|
|
|
3,078 |
|
|
|
|
TOTAL NET
SALES |
6,676 |
|
|
|
|
10,241 |
|
|
|
|
|
|
|
|
|
|
16,917 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenues |
6 |
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
REVENUES |
6,682 |
|
|
|
|
10,243 |
|
|
|
|
|
|
|
|
|
|
16,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS
PROFIT |
4,081 |
|
61 |
% |
|
3,672 |
|
36 |
% |
|
|
|
|
|
|
|
7,753 |
|
46 |
% |
|
(% of
Total Revenues) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research &
Development |
(1,048 |
) |
|
|
|
(653 |
) |
|
|
- |
|
|
|
|
|
|
(1,701 |
) |
|
|
|
Total SG&A plus
depreciation |
(1,979 |
) |
|
|
|
(2,996 |
) |
|
|
|
|
|
(689 |
) |
|
|
(5,664 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
OPERATING
PROFIT (LOSS) |
1,054 |
|
|
|
|
23 |
|
|
|
|
|
|
(689 |
) |
|
|
388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact:
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors:
Lee Roth
The Ruth Group
646-536-7012
lroth@theruthgroup.com
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