Highlights at the end of September 30,
2016:
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today financial results for the third quarter
and nine months ended September 30, 2016, and provided an update on
strategic and operational accomplishments.
Marc Oczachowski, EDAP’s Chief Executive
Officer, stated, “We performed extremely well through the first
nine months of 2016, with total revenues up 22% versus a year ago
and, more importantly, HIFU division revenues up 79% from the
year-ago period.”
“As recently announced, we achieved new
installations in prestigious academic centers in the US such as
Duke University Hospital, and we continue to actively work in
building a strong academic and scientific presence in the US. This
is part of our strategy to penetrate the US market with HIFU on a
strong clinical basis with leading institutions around the
country.”
Mr. Oczachowski concluded, “Recent publications
in both the New England Journal of Medicine and European Urology
are providing extremely encouraging indications that further
position HIFU as a modern standard of care therapy for the
treatment of prostate cancer. We will be pleased to further discuss
these excellent results during our quarterly conference call on
Thursday the 17th of November.”
Third Quarter 2016 Results
Total revenue for the third quarter 2016
was EUR 8.0 million (USD 8.9 million), a 24.7%
year-over-year increase compared to EUR 6.4 million (USD
7.1 million) for the third quarter 2015.
Total revenue in the HIFU business for this
quarter was EUR 2.5 million (USD 2.8 million) compared to EUR 1.2
million (USD 1.3 million) for the third quarter 2015.
For the three months ended September 30, 2016,
total revenue for the Lithotripsy division was EUR 5.4 million (USD
6.1 million), compared to EUR 5.2 million (USD 5.8 million), during
the year ago period.
Gross profit for the third quarter 2016 was EUR
3.5 million (USD 3.9 million), compared to EUR 2.6 million (USD 2.9
million) for the year ago period. Gross profit margin on net sales
was 43.2% in the third quarter of 2016, compared to 40.2% in the
year ago period.
Operating expenses were EUR 3.8 million (USD 4.2
million) for the third quarter 2016, compared to EUR 2.8 million
(USD 3.2 million) for the same period in 2015.
Operating loss for the third quarter 2016 was
EUR 0.3 million (USD 0.4 million), compared with EUR 0.3 million
(USD 0.3 million) in the third quarter of 2015.
Net income for the third quarter 2016 was EUR
1.3 million (USD 1.4 million), or EUR 0.04 per diluted share, as
compared to net loss of EUR 4.8 million (USD 5.4 million), or EUR
0.19 per diluted share, in the year ago period. Net income in the
third quarter of 2016 included non-cash interest income of EUR 1.5
million to adjust the accounting fair value of the outstanding
warrants.
First Nine Months 2016
Results
Total revenue for the first nine months of 2016
was EUR 24.9 million (USD 27.8 million), up 21.8%
compared to EUR 20.5 million (USD 22.7 million) for the
first nine months of 2015.
Gross profit for the first nine months of 2016
was EUR 11.2 million (USD 12.5 million) and gross profit
margin on net sales was 45.0%, compared to 41.5 % in the year ago
period.
The Company recorded an operating profit for the
first nine months of 2016 of EUR 0.1 million (USD 0.1
million), compared with an operating loss of EUR 1.1 million (USD
1.2 million) in the first nine months of 2015.
Net income for the first nine months of 2016
was EUR 5.1 million (USD 5.7 million), or EUR
0.19 per diluted share, as compared to a net loss of EUR
6.8 million (USD 7.5 million), or EUR 0.27 per diluted
share, in the first nine months of 2015. Net loss in the first nine
months of 2016 included non-cash interest income of EUR 4.4
million to adjust the accounting fair value of the outstanding
warrants.
At September 30, 2016, cash and cash
equivalents, including short-term treasury investments,
were EUR 18.8 million (USD 21.2 million).
Conference Call
EDAP will hold a conference call on Thursday,
November 17th, 2016 at 8:30 a.m. EST 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
10095751. 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 December 19,
2016. In addition, a dial-in replay of the call will be
available. The replay dial-in numbers are 1-844-512-2921 for
domestic callers and 1-412-317-6671 for international
callers. Please use event passcode 10095751.
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: |
|
September
30, 2016 Euros |
|
September 30, 2015
Euros |
|
September
30, 2016 $US |
|
September
30, 2015 $US |
Sales of goods |
|
5,218 |
|
|
|
3,754 |
|
|
|
5,836 |
|
|
|
4,178 |
|
Net Sales of RPP and
Leases |
|
1,098 |
|
|
|
1,138 |
|
|
|
1,228 |
|
|
|
1,266 |
|
Sales of spare parts and
Services |
|
1,674 |
|
|
|
1,514 |
|
|
|
1,873 |
|
|
|
1,685 |
|
TOTAL NET
SALES |
|
7,990 |
|
|
|
6,406 |
|
|
|
8,936 |
|
|
|
7,129 |
|
Other revenues |
|
2 |
|
|
|
1 |
|
|
|
2 |
|
|
|
1 |
|
TOTAL
REVENUES |
|
7,992 |
|
|
|
6,407 |
|
|
|
8,938 |
|
|
|
7,130 |
|
Cost of goods |
|
(3,099 |
) |
|
|
(2,262 |
) |
|
|
(3,466 |
) |
|
|
(2,517 |
) |
Cost of RPP and
Leases |
|
(459 |
) |
|
|
(648 |
) |
|
|
(514 |
) |
|
|
(721 |
) |
Cost of spare parts &
services |
|
(979 |
) |
|
|
(921 |
) |
|
|
(1,095 |
) |
|
|
(1,025 |
) |
Cost of sales |
|
(4,537 |
) |
|
|
(3,830 |
) |
|
|
(5,075 |
) |
|
|
(4,262 |
) |
|
|
|
|
|
|
|
|
GROSS
PROFIT |
|
3,454 |
|
|
|
2,578 |
|
|
|
3,864 |
|
|
|
2,868 |
|
Research & development
expenses |
|
(1,032 |
) |
|
|
(612 |
) |
|
|
(1,154 |
) |
|
|
(682 |
) |
Marketing & Sales
expenses |
|
(2,028 |
) |
|
|
(1,518 |
) |
|
|
(2,269 |
) |
|
|
(1,689 |
) |
G & A expenses |
|
(725 |
) |
|
|
(704 |
) |
|
|
(811 |
) |
|
|
(783 |
) |
Total operating
expenses |
|
(3,786 |
) |
|
|
(2,834 |
) |
|
|
(4,234 |
) |
|
|
(3,154 |
) |
|
|
|
|
|
|
|
|
OPERATING PROFIT
(LOSS) |
|
(332 |
) |
|
|
(257 |
) |
|
|
(371 |
) |
|
|
(286 |
) |
Interest (expense) income,
net |
|
1,502 |
|
|
|
(4,460 |
) |
|
|
1,680 |
|
|
|
(4,963 |
) |
Currency exchange gains
(loss), net |
|
130 |
|
|
|
(80 |
) |
|
|
145 |
|
|
|
(89 |
) |
Other income (loss),
net |
|
- |
|
|
|
(2 |
) |
|
|
- |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
|
INCOME (LOSS)
BEFORE TAXES AND MINORITY INTEREST |
|
1,301 |
|
|
|
(4,798 |
) |
|
|
1,455 |
|
|
|
(5,340 |
) |
Income tax (expense)
credit |
|
(40 |
) |
|
|
(31 |
) |
|
|
(44 |
) |
|
|
(35 |
) |
|
|
|
|
|
|
|
|
NET INCOME
(LOSS) |
|
1,261 |
|
|
|
(4,830 |
) |
|
|
1,411 |
|
|
|
(5,375 |
) |
Earnings per share –
Basic |
|
0.04 |
|
|
|
(0.19 |
) |
|
|
0.05 |
|
|
|
(0.22 |
) |
Average number of shares
used in computation of Basic EPS |
|
28,727,616 |
|
|
|
24,972,752 |
|
|
|
28,727,616 |
|
|
|
24,972,752 |
|
Earnings per share –
Diluted |
|
0.04 |
|
|
|
(0.19 |
) |
|
|
0.05 |
|
|
|
(0.22 |
) |
Average number of shares
used in computation of Diluted EPS |
|
30,251,966 |
|
|
|
24,972,752 |
|
|
|
30,251,966 |
|
|
|
24,972,752 |
|
|
|
|
|
|
|
|
|
NOTE: Translated for convenience of the reader
to U.S. dollars at the 2016 average three months’ noon buying rate
of 1 Euro = 1.1184 USD, and 2015 average three months’ noon buying
rate of 1 Euro = 1.1128 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,
2016 Euros |
|
September
30, 2015 Euros |
|
September
30, 2016 $US |
|
September
30, 2015 $US |
Sales of goods |
|
16,480 |
|
|
|
12,857 |
|
|
|
18,356 |
|
|
|
14,275 |
|
Net Sales of RPP and
Leases |
|
3,675 |
|
|
|
3,258 |
|
|
|
4,094 |
|
|
|
3,617 |
|
Sales of spare parts and
Services |
|
4,752 |
|
|
|
4,344 |
|
|
|
5,293 |
|
|
|
4,822 |
|
TOTAL NET
SALES |
|
24,907 |
|
|
|
20,458 |
|
|
|
27,742 |
|
|
|
22,714 |
|
Other revenues |
|
10 |
|
|
|
3 |
|
|
|
11 |
|
|
|
4 |
|
TOTAL
REVENUES |
|
24,917 |
|
|
|
20,461 |
|
|
|
27,753 |
|
|
|
22,717 |
|
Cost of goods |
|
(8,660 |
) |
|
|
(7,303 |
) |
|
|
(9,646 |
) |
|
|
(8,108 |
) |
Cost of RPP and
Leases |
|
(1,972 |
) |
|
|
(1,940 |
) |
|
|
(2,197 |
) |
|
|
(2,154 |
) |
Cost of spare parts &
services |
|
(3,076 |
) |
|
|
(2,730 |
) |
|
|
(3,427 |
) |
|
|
(3,030 |
) |
Cost of sales |
|
(13,709 |
) |
|
|
(11,972 |
) |
|
|
(15,269 |
) |
|
|
(13,292 |
) |
|
|
|
|
|
|
|
|
GROSS
PROFIT |
|
11,208 |
|
|
|
8,489 |
|
|
|
12,484 |
|
|
|
9,425 |
|
Research & development
expenses |
|
(2,733 |
) |
|
|
(2,125 |
) |
|
|
(3,044 |
) |
|
|
(2,359 |
) |
Marketing & Sales
expenses |
|
(6,041 |
) |
|
|
(4,926 |
) |
|
|
(6,728 |
) |
|
|
(5,469 |
) |
G & A expenses |
|
(2,377 |
) |
|
|
(2,534 |
) |
|
|
(2,648 |
) |
|
|
(2,813 |
) |
Total operating
expenses |
|
(11,151 |
) |
|
|
(9,585 |
) |
|
|
(12,420 |
) |
|
|
(10,641 |
) |
|
|
|
|
|
|
|
|
OPERATING PROFIT
(LOSS) |
|
57 |
|
|
|
(1,096 |
) |
|
|
63 |
|
|
|
(1,217 |
) |
Interest (expense) income,
net |
|
4,393 |
|
|
|
(5,804 |
) |
|
|
4,893 |
|
|
|
(6,444 |
) |
Currency exchange gains
(loss), net |
|
801 |
|
|
|
223 |
|
|
|
892 |
|
|
|
247 |
|
Other income (loss),
net |
(0)- |
|
|
(5 |
) |
|
|
(1 |
) |
|
|
(5 |
) |
|
|
|
|
|
|
|
|
INCOME (LOSS)
BEFORE TAXES AND MINORITY INTEREST |
|
5,250 |
|
|
|
(6,682 |
) |
|
|
5,848 |
|
|
|
(7,419 |
) |
Income tax (expense)
credit |
|
(130 |
) |
|
|
(100 |
) |
|
|
(145 |
) |
|
|
(112 |
) |
|
|
|
|
|
|
|
|
NET INCOME
(LOSS) |
|
5,120 |
|
|
|
(6,783 |
) |
|
|
5,703 |
|
|
|
(7,530 |
) |
Earnings per share –
Basic |
|
0.19 |
|
|
|
(0.27 |
) |
|
|
0.21 |
|
|
|
(0.30 |
) |
Average number of shares
used in computation of Basic EPS |
|
27,497,107 |
|
|
|
24,942,689 |
|
|
|
27,497,107 |
|
|
|
24,942,689 |
|
Earnings per share –
Diluted |
|
0.19 |
|
|
|
(0.27 |
) |
|
|
0.21 |
|
|
|
(0.30 |
) |
Average number of shares
used in computation of Diluted EPS |
|
29,045,939 |
|
|
|
24,942,689 |
|
|
|
29,045,939 |
|
|
|
24,942,689 |
|
|
|
|
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2016 average nine months’ noon buying
rate of 1 Euro = 1.1138 USD, and 2015 average nine months’ noon
buying rate of 1 Euro = 1.1102 USD.
EDAP TMS S.A. CONSOLIDATED
BALANCE SHEETS HIGHLIGHTS (Amounts in thousands of Euros and U.S.
Dollars) |
|
|
|
|
|
|
Sept. 30, 2016
Euros |
June 30,
2016 Euros |
Sept. 30,
2016 $US |
June 30,
2016 $US |
|
|
|
|
|
Cash, cash equivalents and
short term investments |
18,837 |
21,940 |
21,170 |
24,203 |
Total current assets |
40,694 |
40,963 |
45,734 |
45,188 |
Total current
liabilities |
14,547 |
14,817 |
16,349 |
16,345 |
Shareholders’ Equity |
25,739 |
24,358 |
28,926 |
26,870 |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1238
USD on September 30, 2016 and at the noon buying rate of 1 Euro =
1.1031 USD, on June 30, 2016
EDAP TMS S.A. CONDENSED
STATEMENTS OF OPERATIONS BY DIVISION NINE
MONTHS ENDED SEPTEMBER 30, 2016 (Amounts in
thousands of Euros) |
|
|
|
|
|
|
|
|
|
|
|
|
HIFU Division |
|
UDS Division |
|
FDA |
|
Corporate |
|
Total After Consolidation |
|
|
|
|
|
|
|
|
|
|
|
|
Sales of goods |
|
6,047 |
|
|
|
10,433 |
|
|
|
|
|
|
|
16,480 |
|
|
Sales of RPPs &
Leases |
|
2,633 |
|
|
|
1,042 |
|
|
|
|
|
|
|
3,675 |
|
|
Sales of spare parts &
services |
|
543 |
|
|
|
4,209 |
|
|
|
|
|
|
|
4,752 |
|
|
TOTAL NET
SALES |
|
9,223 |
|
|
|
15,684 |
|
|
|
|
|
|
|
24,907 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenues |
|
6 |
|
|
|
4 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
REVENUES |
|
9,229 |
|
|
|
15,688 |
|
|
|
|
|
|
|
24,917 |
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT (% of
Total Revenues) |
|
5,337 |
|
|
58 |
% |
|
5,871 |
|
|
37 |
% |
|
|
|
|
|
11,208 |
|
|
45 |
% |
|
|
|
|
|
|
|
|
|
|
|
Research &
Development |
|
(1,781 |
) |
|
|
(952 |
) |
|
- |
|
|
- |
|
|
|
(2,733 |
) |
|
Total SG&A plus
depreciation |
|
(3,027 |
) |
|
|
(4,440 |
) |
|
- |
|
|
(951 |
) |
|
|
(8,418 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING PROFIT
(LOSS) |
|
529 |
|
|
|
479 |
|
|
- |
|
|
(951 |
) |
|
|
57 |
|
|
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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