2016 Highlights
- Total revenue for 2016 reached double-digit growth, increasing
to EUR 35.6 million (USD 39.3 million)
- Gross margin for 2016 expanded to 46.1% compared to 42.8%
during the prior year period
- Strong cash position of EUR 22.0 million (USD 23.2 million) as
of December 31, 2016
LYON, France, April 3, 2017 -- EDAP TMS SA (Nasdaq:EDAP), the
global leader in therapeutic ultrasound, announced today financial
results for the fourth quarter and twelve months ended December 31,
2016, and provided an update on strategic and operational
accomplishments.
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "I am
thrilled with the performance of our team in 2016. We successfully
grew our HIFU revenue more than 63% to EUR 13.8 million, resulting
in total 2016 revenue of EUR 35.6 million. EDAP strengthened its
HIFU presence in the U.S. during 2016, adding key academic centers
to its HIFU user base while significantly expanding operations
globally. Ablatherm® and the Focal One® continued to enjoy a warm
reception from the global medical community supported by strong,
positive clinical data. Notably, Focal One's innovative prostate
treatment received clear recognition from the global scientific
community when awarded the prestigious Prix Galien Award this past
December."
Mr. Oczachowski concluded, "2016 was rich in positive events;
please join us Tuesday, April 4, 2017, for a detailed discussion of
our continued success and expansion."
Fourth Quarter 2016 Results
Total revenue for the fourth quarter 2016 was EUR 10.7 million
(USD 11.4 million), a 9.3% decreased compared to EUR 11.8 million
(USD 12.8 million) for the fourth quarter of 2015.
Total revenue in the HIFU business for the fourth quarter was
EUR 4.6 million (USD 4.9 million), a 38.3% increase compared to EUR
3.3 million (USD 3.6 million) for the fourth quarter of
2015.
For the three months ended December 31, 2016, total revenue for
the Lithotripsy division was EUR 6.1 (USD 6.5 million), a 27.9%
decreased compared to EUR 8.5 million (USD 9.2 million) during the
year-ago period.
Gross profit for the fourth quarter 2016 was EUR 5.2 million
(USD 5.6 million), compared to EUR 5.3 million (USD 5.7 million)
for the year-ago period. Gross profit margin on net sales was 48.8%
in the fourth quarter of 2016, compared to 45.0% in the year-ago
period.
Operating expenses were EUR 4.9 million (USD 5.2 million) for
the fourth quarter of 2016, compared to EUR 3.7 million (USD 4.0
million) for the same period in 2015.
Operating profit for the fourth quarter 2016 was EUR 0.3 million
(USD 0.4 million), compared to EUR 1.6 million (USD 1.7 million) in
the fourth quarter of 2015.
Net loss for the fourth quarter 2016 was EUR 1.3 (USD 1.4
million), or a loss of EUR 0.04 per diluted share, as compared to
net income of EUR 5.1 million (USD 5.5 million), or EUR 0.18 per
diluted share in the year-ago period. Net income in the
fourth quarter of 2016 included non-cash interest expense of EUR
0.4 million (USD 0.5 million) to adjust the accounting fair value
of the outstanding warrants.
Year Ended 2016 Results
Total revenue for 2016 was EUR 35.6 million (USD 39.3 million),
an increase of 10.4% compared to EUR 32.3 million (USD 35.6) for
the year ended December 31, 2015.
Total revenue in the HIFU business for 2016 was EUR 13.8 million
(USD 15.2 million), an increase of 63.0% compared to EUR 8.5
million (USD 9.4 million) for the year ended December 31, 2015.
Total revenue in the Lithotripsy business for 2016 was EUR 21.8
million (USD 24.0 million), a decrease of 8.3% compared to EUR 23.8
million (USD 26.2 million) for the year ended December 31,
2015.
Gross profit for 2016 was EUR 16.4 million (USD 18.1 million),
with gross profit margin on net sales of 46.1%, compared to 42.8%
during the prior year period.
The Company recorded operating profit for 2016 of EUR 0.4
million (USD 0.4 million), compared to an operating profit of EUR
0.5 million (USD 0.5 million) during the prior year period.
Full-year net income was EUR 3.8 million (USD 4.2 million), or
EUR 0.13 per diluted share, as compared to a net loss of EUR 1.7
million (USD 1.8 million), or a loss of EUR 0.07 per diluted share
in 2015. Full-year net income included non-cash interest income of
EUR 4.0 million to adjust the accounting fair value of the
outstanding warrants.
At December 31, 2016, cash and cash equivalents were EUR 22.0
million (USD 23.2 million).
Conference Call
An accompanying conference call will be conducted by Marc
Oczachowski, Chief Executive Officer, and Francois Dietsch, Chief
Financial Officer, to go over the results. The call will be held at
8:30 AM ET, on Tuesday, April 4, 2017. Please refer to the
information below for conference call dial-in information and
webcast registration.
Conference Date: Tuesday, April 4, 2017 8:30 AM ET Conference
dial-in: 877-269-7756 International dial-in: 201-689-7817
Conference Call Name: EDAP-TMS Fourth Quarter and Full Year 2016
Results Call Webcast Registration: Click Here
Following the live call, a replay will be available on the
Company's website, www.edap-tms.com under "Investors
Information."
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 (Amounts in thousands of Euros and U.S.
Dollars, except per share data)
|
Three Months Ended: |
|
Three Months Ended: |
|
|
December 31, |
|
December 31, |
|
December 31, |
|
December 31, |
|
2016 |
2015 |
2016 |
2015 |
|
Euros |
Euros |
$US |
$US |
|
Sales of medical
equipment |
7,566 |
|
9,049 |
|
8,093 |
|
9,792 |
|
Net Sales of RPP and
Leases |
1,231 |
1,151 |
1,317 |
1,245 |
|
Sales of spare parts,
supplies and Services |
1,875 |
1,560 |
2,006 |
1,688 |
|
TOTAL NET
SALES |
10,672 |
|
11,760 |
|
11,417 |
|
12,726 |
|
Other revenues |
22 |
|
32 |
|
24 |
|
35 |
|
TOTAL
REVENUES |
10,695 |
|
11,792 |
|
11,441 |
|
12,760 |
|
Cost of sales |
-5,492 |
|
-6,495 |
|
-5,875 |
|
-7,029 |
|
GROSS
PROFIT |
5,203 |
|
5,297 |
|
5,566 |
|
5,732 |
|
Research &
development expenses |
-1,135 |
|
-565 |
|
-1,214 |
|
-612 |
|
S, G & A
expenses |
-3,733 |
|
-3,147 |
|
-3,994 |
|
-3,406 |
|
Total operating
expenses |
-4,868 |
|
-3,713 |
|
-5,208 |
|
-4,018 |
|
OPERATING PROFIT
(LOSS) |
335 |
|
1,584 |
|
358 |
|
1,714 |
|
Interest (expense)
income, net |
-444 |
|
3,710 |
|
-475 |
|
4,015 |
|
Currency exchange gains
(loss), net |
-698 |
|
476 |
|
-746 |
|
516 |
|
Other income (loss),
net |
- |
|
5 |
|
- |
|
5 |
|
INCOME (LOSS) BEFORE
TAXES AND MINORITY INTEREST |
-807 |
|
5,775 |
|
-863 |
|
6,249 |
|
Income tax (expense)
credit |
-471 |
|
-659 |
|
-504 |
|
-713 |
|
NET
INCOME (LOSS) |
-1,278 |
|
5,116 |
|
-1,367 |
|
5,536 |
|
|
|
Earning per share -
Basic |
-0.04 |
|
0.2 |
|
-0.05 |
|
0.22 |
|
Average number of
shares used in computation of EPS |
28,727,616 |
|
25,254,618 |
|
28,727,616 |
|
25,254,618 |
|
Earning per share -
Diluted |
-0.04 |
|
0.18 |
|
-0.05 |
|
0.19 |
|
Average number of
shares used in computation of EPS for positive net income |
28,727,616 |
|
28,846,270 |
|
28,727,616 |
|
28,846,270 |
|
NOTE: Translated for convenience of the reader to
U.S. dollars at the 2016 average three months' noon buying rate of
1 Euro = 1.0697 USD, and 2015 average three months noon buying rate
of 1 Euro = 1.0821 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, |
|
December 31, |
|
December 31, |
|
December 31, |
2016 |
2015 |
2016 |
2015 |
Euros |
Euros |
$US |
$US |
Sales of medical
equipment |
24,045 |
|
21,906 |
|
26,520 |
|
24,168 |
Net Sales of RPP and
Leases |
4,906 |
|
4,408 |
|
5,411 |
|
4,864 |
Sales of spare parts,
supplies and |
6,628 |
|
5,904 |
|
7,310 |
|
6,513 |
Services |
TOTAL NET
SALES |
35,579 |
|
32,218 |
|
39,240 |
|
35,545 |
Other revenues |
32 |
|
35 |
|
35 |
|
39 |
TOTAL
REVENUES |
35,611 |
|
32,253 |
|
39,276 |
|
35,584 |
Cost of sales |
-19,200 |
|
-18,468 |
|
-21,176 |
|
-20,375 |
GROSS
PROFIT |
16,411 |
|
13,785 |
|
18,100 |
|
15,209 |
Research &
development expenses |
-3,868 |
|
-2,690 |
|
-4,266 |
|
-2,968 |
S, G & A
expenses |
-12,152 |
|
-10,608 |
|
-13,402 |
|
-11,703 |
Total operating
expenses |
-16,019 |
|
-13,298 |
|
-17,668 |
|
-14,671 |
OPERATING PROFIT
(LOSS) |
392 |
|
488 |
|
432 |
|
538 |
Interest (expense)
income, net |
3,949 |
|
-2,094 |
|
4,355 |
|
-2,310 |
Currency exchange gains
(loss), net |
103 |
|
699 |
|
114 |
|
771 |
Other income (loss),
net |
- |
|
- |
|
- |
|
- |
INCOME (LOSS) BEFORE
TAXES AND MINORITY INTEREST |
4,444 |
|
-907 |
|
4,901 |
|
-1,001 |
Income tax (expense)
credit |
-602 |
|
-759 |
|
-663 |
|
-838 |
NET INCOME
(LOSS) |
3,842 |
|
-1,667 |
|
4,238 |
|
-1,839 |
Earning per share -
Basic |
0.14 |
|
-0.07 |
|
0.15 |
|
-0.07 |
Average number of
shares used in |
27,823,313 |
|
25,021,966 |
|
27,823,313 |
|
25,021,966 |
computation of EPS |
Earning per share -
Diluted |
0.13 |
|
-0.07 |
|
0.14 |
|
-0.07 |
Average number of
shares used in computation of EPS for positive net income |
29,365,583 |
|
25,021,966 |
|
29,365,583 |
|
25,021,966 |
NOTE: Translated for convenience of the reader to
U.S. dollars at the 2016 average twelve months noon buying rate of
1 Euro = 1.1029 USD, and 2015 average twelve months noon buying
rate of 1 Euro = 1.1033 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, |
|
2016 |
2016 |
2016 |
2016 |
Euros |
Euros |
$US |
$US |
Cash, cash equivalents
and short term investments |
21,989 |
|
18,837 |
23,202 |
|
21,170 |
|
Total current
assets |
40,514 |
|
40,694 |
42,750 |
|
45,734 |
|
Total current
liabilities |
15,010 |
|
14,547 |
15,838 |
|
16,349 |
|
Shareholders'
Equity |
24,451 |
|
25,739 |
25,800 |
|
28,926 |
|
NOTE: Translated for convenience of the reader to
U.S. dollars at the noon buying rate of 1 Euro = 1.0552 USD, on
December 31, 2016 and at the noon buying rate of 1 Euro = 1.1238
USD, on September 30, 2016.
EDAP TMS S.A.CONDENSED STATEMENTS OF
OPERATIONS BY DIVISIONTWELVE MONTHS ENDED DECEMBER 31,
2016(Amounts in thousands of Euros)
|
|
|
|
|
|
|
|
Total After Consolidation |
|
HIFU Division |
UDS
Division |
Corporate |
|
|
|
|
|
|
|
|
|
|
|
Sales of goods |
9,382 |
14,664 |
24,045 |
|
Sales of RPPs &
Leases |
3,547 |
|
1,359 |
|
|
|
|
4,906 |
|
Sales of spare parts
& services |
862 |
|
5,766 |
|
|
|
|
6,628 |
|
TOTAL NET
SALES |
13,791 |
|
21,789 |
|
|
|
|
35,579 |
|
|
|
Other
revenues |
28 |
|
4 |
|
|
|
|
32 |
|
|
TOTAL
REVENUES |
13,819 |
|
21,792 |
|
|
|
|
35,611 |
|
GROSS
PROFIT |
8,109 |
58.70% |
8,302 |
38.10% |
|
|
|
16,411 |
46.10% |
(% of Total
Revenues) |
|
|
|
|
|
|
|
|
|
|
|
|
|
-1,416 |
|
|
|
|
-3,868 |
|
Research &
Development |
-2,452 |
|
Total SG&A plus
depreciation |
-4,692 |
|
-6,145 |
|
|
-1,315 |
|
-12,152 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING PROFIT
(LOSS) |
964 |
742 |
-1,315 |
392 |
|
Company Contact:
Blandine ConfortInvestor Relations / Legal AffairsEDAP TMS SA+33
4 72 15 31 72bconfort@edap-tms.com
Investor Contact:
Rich CockrellCG
Capital877-889-1972investorrelations@cg.capital
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