- Total revenue of EUR 8.7 million (USD 9.3 million) for Q1
2017
- +16.5% growth in HIFU treatment driven recurring revenues
- Strong cash position of EUR 20.3 million (USD 21.7 million) as
of March 31, 2017
- CMS Medicare C-code submission for HIFU reimbursement in the
U.S.
- Ablatherm Fusion World Premiere at AUA in Boston May 12-16
LYON, France, May 17, 2017 -- EDAP TMS SA (Nasdaq: EDAP), the
global leader in therapeutic ultrasound, announced today financial
results for the first quarter ended March 31, 2017, and provided an
update on strategic and operational accomplishments.
"Our first quarter revenues remain in line with our revenues
from first quarter 2016", said Marc Oczachowski, EDAP's Chief
Executive Officer. "We continue to expand our education efforts in
the U.S. as demonstrated by our successful addition of more than 50
new urologists to our HIFU training program during the first
quarter. As a result, momentum in the U.S. continues as evidenced
by the significant growth of our pipeline of HIFU projects. Global
HIFU treatment driven revenue continues to increase with 16.5%
growth year over year, while our global UDS/Lithotripsy business
grew 16.5% compared to the first quarter of 2016."
Marc Oczachowski added: "We are well positioned to continue with
our strategic initiatives to ensure a solid foundation for growth
in the U.S. market. In late February 2017, we submitted our dossier
for reimbursement to CMS Medicare for C-code allocation; we expect
feedback from CMS no later than July 2017. We have also expanded
our HIFU product offerings with the addition of our Ablatherm
Fusion device, announced during the American Urological
Association's annual conference in Boston last weekend."
First Quarter 2017 Results
Total revenue for the first quarter 2017 was EUR 8.7 million
(USD 9.3 million), a 0.6% decreased compared to EUR 8.7 million
(USD 9.6 million) for the first quarter of 2016.
For the three months ended March 31, 2017, total revenue for the
Lithotripsy division was EUR 6.4 million (USD 6.8 million), a 16.5%
increase compared to EUR 5.5 million (USD 6.0 million) during the
year-ago period.
Total revenue in the HIFU business for the first quarter was EUR
2.3 million (USD 2.5 million), a 29.1% decrease compared to EUR 3.3
million (USD 3.6 million) for the first quarter of 2016.
Gross profit for the first quarter 2017 was EUR 3.6 million (USD
3.8 million), compared to EUR 4.3 million (USD 4.7 million) for the
year-ago period. Gross profit margin on net sales was 41.1% in the
first quarter of 2017, compared to 49.2% in the prior year
period.
Operating loss for the first quarter 2017 was EUR 0.4 million
(USD 0.4 million), compared to an operating profit of EUR 0.7
million (USD 0.8 million) in the first quarter of 2016.
Net income for the first quarter 2017 was EUR 1.7 million (USD
1.8 million), or earnings of EUR 0.06 per diluted share, as
compared to net income of EUR 1.4 million (USD 1.5 million), or
earnings of EUR 0.05 per diluted share in the year-ago period. Net
income in the first quarter of 2017 included non-cash interest
income of EUR 2.0 million (USD 2.1 million) to adjust the
accounting fair value of the outstanding warrants.
Conference Call
An accompanying conference call will be conducted by Philippe
Chauveau, Chairman of the Board; 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 Thursday, May
18, 2017. Please refer to the information below for conference call
dial-in information and webcast registration.
Conference Date: Thursday, May 18, 2017, 8:30 AM ET
Conference dial-in: 877-269-7756 International
dial-in: 201-689-7817 Conference Call Name:
EDAP-TMS First Quarter 2017 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. Ablatherm Fusion is not FDA cleared yet. 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: |
|
Mar.
31, 2017Euros |
|
Mar.
31, 2016Euros |
|
Mar.
31, 2017$US |
|
Mar.
31, 2016$US |
Sales of medical equipment
Net Sales of RPP and Leases |
5,5121,295 |
|
5,9991,262 |
|
5,8991,386 |
|
6,6171,392 |
Sales of spare parts,
supplies and Services |
1,842 |
|
1,467 |
|
1,972 |
|
1,618 |
TOTAL NET
SALES |
8,648 |
|
8,728 |
|
9,257 |
|
9,627 |
Other revenues |
26 |
|
- |
|
28 |
|
- |
TOTAL REVENUES |
8,675 |
|
8,728 |
|
9,285 |
|
9,627 |
Cost of sales |
(5,123) |
|
(4,436) |
|
(5,483) |
|
(4,893) |
GROSS PROFIT |
3,551 |
|
4,292 |
|
3,801 |
|
4,734 |
Research & development
expenses |
(896) |
|
(814) |
|
(959) |
|
(898) |
S, G & A expenses |
(3,075) |
|
(2,745) |
|
(3,291) |
|
(3,028) |
Total operating
expenses |
(3,971) |
|
(3,559) |
|
(4,250) |
|
(3,926) |
OPERATING PROFIT
(LOSS) |
(419) |
|
733 |
|
(449) |
|
808 |
Interest (expense) income,
net |
1,983 |
|
479 |
|
2,123 |
|
528 |
Currency exchange gains
(loss), net |
175 |
|
188 |
|
188 |
|
207 |
Other income (loss),
net |
- |
|
- |
|
- |
|
- |
INCOME (LOSS) BEFORE
TAXES AND MINORITY INTEREST |
1,739 |
|
1,400 |
|
1,861 |
|
1,544 |
Income tax (expense)
credit |
(58) |
|
(39) |
|
(62) |
|
(43) |
NET INCOME (LOSS)
|
1,681 |
|
1,360 |
|
1,799 |
|
1,501 |
Earning per share -
Basic |
0.06 |
|
0.05 |
|
0.06 |
|
0.06 |
Average number of shares
used in computation of EPS |
28,839,099 |
|
25,400,445 |
|
28,839,099 |
|
25,400,445 |
Earning per share -
Diluted |
0.06 |
|
0.05 |
|
0.06 |
|
0.06 |
Average number of shares
used in computation of EPS for positive net income |
30,213,544 |
|
26,987,182 |
|
30,213,544 |
|
26,987,182 |
NOTE: Translated for convenience of the reader to
U.S. dollars at the 2017 average three months' noon buying rate of
1 Euro = 1.0703 USD, and 2016 average three months' noon buying
rate of 1 Euro = 1.1030 USD.
EDAP TMS S.A.CONSOLIDATED BALANCE
SHEETS HIGHLIGHTS (Amounts in thousands of Euros and U.S.
Dollars)
|
Mar. 31, 2017 Euros |
|
|
Dec. 31, 2016 Euros |
Mar. 31, 2017 $US |
|
Dec. 31, 2016 $US |
|
|
Cash, cash equivalents and
short term investments |
20,321 |
|
|
21,989 |
21,739 |
|
23,202 |
|
|
Total current assets |
40,542 |
|
|
40,514 |
43,370 |
|
42,750 |
|
|
Total current
liabilities |
14,052 |
|
|
15,010 |
15,032 |
|
15,838 |
|
|
Shareholders' Equity |
26,904 |
|
|
24,451 |
28,780 |
|
25,800 |
|
|
NOTE: Translated for convenience of the reader to
U.S. dollars at the noon buying rate of 1 Euro = 1.0697 USD, on
March 31, 2017 and at the noon buying rate of 1 Euro = 1.0552 USD,
on December 31, 2016.
EDAP TMS S.A.CONDENSED STATEMENTS OF
OPERATIONS BY DIVISIONTHREE MONTHS ENDED MARCH 31,
2017(Amounts in thousands of Euros)
|
HIFU
Division |
|
UDS
Division |
|
Corporate |
|
Total
After Consolidation |
|
Sales of goods |
1,048 |
|
4,464 |
|
|
|
5,512 |
|
Sales of RPPs &
Leases |
958 |
|
336 |
|
|
|
1,295 |
|
Sales of spare parts &
services |
317 |
|
1,525 |
|
|
|
1,842 |
|
TOTAL NET SALES
|
2,323 |
|
6,325 |
|
|
|
8,648 |
|
Other revenues |
- |
|
26 |
|
|
|
26 |
|
TOTAL REVENUES |
2,323 |
|
6,352 |
|
|
|
8,675 |
|
GROSS PROFIT(%
of Total Revenues) |
1,227 |
53% |
2,325 |
37% |
|
|
3,551 |
41% |
Research &
Development |
(579) |
|
(317) |
|
|
|
(896) |
|
Total SG&A plus
depreciation |
(1,112) |
|
(1,596) |
|
(366) |
|
(3,075) |
|
OPERATING PROFIT
(LOSS) |
(465) |
|
411 |
|
(366) |
|
(419) |
|
Investor Contact
CG CAPITALRich
Cockrell877.889.1972investorrelations@cg.capital
Company Contact
Blandine ConfortInvestor Relations / Legal Affairs EDAP TMS
SA+33 4 72 15 31 50bconfort@edap-tms.com
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