EDAP Reports First Quarter 2015 Results
12 Mayo 2015 - 3:05PM
1Q 2015 and Recent Operational Highlights
- Direct De Novo petition for Ablatherm HIFU submitted to the FDA
in April 2015;
- Treatment-driven revenue from the HIFU division increased 17%
year-over-year;
- Revenue for first quarter 2015 totaled EUR 6.2 million (USD 6.9
million);
- Canadian regulatory approval of Focal One; first device sold
and initial patients successfully treated
- Cash position remains strong at EUR 11.3 million (USD 12.1
million) as of March 31, 2015;
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced financial results for the first quarter
ended March 31, 2015 and provided an update on recent strategic
developments.
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "This
quarter is in line with our normal business cycle, while Q1 2014
was an exceptional one for the Company with five HIFU systems sold.
More specifically, our results in the first quarter of 2015 reflect
the continued momentum in HIFU treatments, as we achieved a 17%
year-over-year increase in procedure-driven revenue from the HIFU
division. This positive trend confirms the increasing adoption of
HIFU among urologists and a growing appreciation of the technology
as a safe and effective therapeutic option for prostate cancer
patients."
Mr. Oczachowski added, "We are pleased to announce that, as
planned, we submitted our Direct De Novo 510(k) petition for
Ablatherm HIFU to the FDA after the close of the first quarter, and
look forward to moving ahead with the review process." Total
revenue in the HIFU business for the quarter was EUR 1.6 million
(USD 1.8 million). HIFU revenue included the sale of one Focal One
system in Canada.
For the three months ended March 31, 2015, total revenue for the
Lithotripsy division was EUR 4.6 million (USD 5.1 million),
compared to EUR 4.5 million (USD 6.1 million), during the year ago
period.
Gross profit for the first quarter 2015 was EUR 2.6 million (USD
2.9 million), compared to EUR 3.6 million (USD 4.9 million) for the
year ago period. Gross profit margin on net sales was 41.5% in the
first quarter of 2015, compared to 45.9% in the year ago
period.
Operating expenses were EUR 3.2 million (USD 3.5 million) for
the first quarter 2015, compared to EUR 3.0 million (USD 4.1
million) for the same period in 2014.
Operating loss for the first quarter was EUR 622,000 (USD
689,000), compared with operating income in the first quarter of
2014 of EUR 558,000 (USD 765,000).
Net loss for the first quarter 2015 was EUR 2.4 million (USD 2.7
million), or EUR 0.10 per diluted share, as compared to net income
of EUR 840,000 (USD 1.1 million), or EUR 0.04 per diluted share, in
the year ago period. Net loss in the first quarter 2015 included a
non-cash interest expense of EUR 2.4 million to adjust the
accounting fair value of the outstanding warrants.
Conference Call
EDAP will hold a conference call on Wednesday, May 13, 2015 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 10065516. 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 June 13, 2015. In
addition, a dial-in replay of the call will be available until May
20, 2015. 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 10065516.
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused
ultrasound (HIFU) treatment of localized prostate cancer outside
the U.S. 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 for commercial
distribution in Europe and some other countries including Mexico
and Canada. EDAP TMS is currently pursuing a Direct De Novo 510(K)
petition in parallel to a PMA for Ablatherm 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 uncertainties of the U.S. FDA clearance 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-cleared or marketed in the United States.
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
: |
|
|
|
March 31, |
March 31, |
March 31, |
March 31, |
|
2015 |
2014 |
2015 |
2014 |
|
Euros |
Euros |
$US |
$US |
Sales of goods |
3,746 |
5,414 |
4,149 |
7,415 |
Net Sales of RPP and Leases |
1,029 |
998 |
1,140 |
1,367 |
Sales of spare parts and |
|
|
|
|
Services |
1,442 |
1,349 |
1,597 |
1,848 |
TOTAL NET SALES |
6,217 |
7,762 |
6,886 |
10,630 |
Other revenues |
-- |
3 |
-- |
4 |
TOTAL REVENUES |
6,217 |
7,765 |
6,886 |
10,634 |
Cost of goods |
(2,045) |
(2,815) |
(2,265) |
(3,855) |
Cost of RPP and Leases |
(644) |
(505) |
(713) |
(692) |
Cost of spare parts & services |
(948) |
(881) |
(1,050) |
(1,206) |
Cost of sales |
(3,637) |
(4,201) |
(4,028) |
(5,753) |
|
|
|
|
|
GROSS PROFIT |
2,580 |
3,564 |
2,858 |
4,881 |
Research & development expenses |
(773) |
(686) |
(857) |
(939) |
Marketing & Sales expenses |
(1,549) |
(1,441) |
(1,716) |
(1,973) |
G & A expenses |
(880) |
(879) |
(974) |
(1,204) |
Total operating expenses |
(3,202) |
(3,006) |
(3,547) |
(4,116) |
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(622) |
558 |
(689) |
765 |
Interest (expense) income, net |
(2,350) |
259 |
(2,602) |
355 |
Currency exchange gains (loss), net |
565 |
55 |
626 |
76 |
Other income (loss), net |
(3) |
(3) |
(3) |
(4) |
|
|
|
|
|
INCOME (LOSS) BEFORE TAXES AND
MINORITY INTEREST |
(2,410) |
870 |
(2,669) |
1,192 |
Income tax (expense) credit |
(30) |
(30) |
(34) |
(41) |
|
|
|
|
|
NET INCOME (LOSS) |
(2,440) |
840 |
(2,703) |
1,151 |
Earnings per share – Basic |
(0.10) |
0.04 |
(0.11) |
0.05 |
Average number of shares used
in computation of EPS |
24,894,049 |
21,789,670 |
24,894,049 |
21,789,670 |
Earnings per share – Diluted |
(0.10) |
0.04 |
(0.11) |
0.05 |
Average number of shares used
in computation of EPS for positive net income |
24,894,049 |
23,951,832 |
24,894,049 |
23,951,832 |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the 2015 average three months noon buying
rate of 1 Euro = 1.1075 USD, and 2014 average three months
noon buying rate of 1 Euro = 1.3695 USD. |
|
EDAP TMS
S.A. |
CONSOLIDATED BALANCE
SHEETS HIGHLIGHTS (Amounts in thousands of Euros and U.S.
Dollars) |
|
|
Mar. 31, |
Dec. 31, |
Mar. 31, |
Dec. 31, |
|
2015 |
2014 |
2015 |
2014 |
|
Euros |
Euros |
$US |
$US |
|
|
|
|
|
Cash, cash equivalents and short term
investments |
11,285 |
12,142 |
12,121 |
14,693 |
Total current assets |
26,792 |
26,552 |
28,778 |
32,130 |
Total current liabilities |
12,021 |
12,158 |
12,912 |
14,711 |
Shareholders' Equity |
12,829 |
15,141 |
13,780 |
18,322 |
|
|
|
|
|
NOTE: Translated for convenience of the
reader to U.S. dollars at the noon buying rate of 1 Euro = 1.0741
USD, on March 31, 2015 and at the noon buying rate of 1 Euro =
1.2101 USD, on December 31, 2014. |
|
EDAP TMS
S.A. |
CONDENSED STATEMENTS OF
OPERATIONS BY DIVISION |
THREE MONTHS ENDED
MARCH 31, 2015 |
(Amounts in thousands
of Euros) |
|
|
|
|
|
|
|
|
Total After |
|
|
HIFU Division |
|
UDS Division |
|
FDA Trials |
Corporate |
Consolidation |
|
|
|
|
|
|
|
|
|
|
Sales of goods |
861 |
|
2,885 |
|
|
|
3,746 |
|
Sales of RPPs & Leases |
608 |
|
422 |
|
|
|
1,029 |
|
Sales of spare parts & services |
146 |
|
1,296 |
|
|
|
1,442 |
|
TOTAL NET SALES |
1,615 |
|
4,603 |
|
|
|
6,217 |
|
|
|
|
|
|
|
|
|
|
Other revenues |
-- |
|
-- |
|
|
|
-- |
|
|
|
|
|
|
|
|
|
|
TOTAL REVENUES |
1,615 |
|
4,603 |
|
|
|
6,217 |
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT |
866 |
54% |
1,714 |
37% |
|
|
2,580 |
42% |
(% of Total Revenues) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research & Development |
(395) |
|
(225) |
|
(153) |
|
(773) |
|
Total SG&A plus depreciation |
(675) |
|
(1,387) |
|
|
(367) |
(2,429) |
|
|
|
|
|
|
|
|
|
|
OPERATING PROFIT (LOSS) |
(204) |
|
102 |
|
(153) |
(367) |
(622) |
|
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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