EDAP-TMS Reports Record Second Quarter and First Half 2017
Results
- Revenue increased 13.7% to a record €9.3 million for the second
quarter of 2017 compared to €8.2 million in 2016
- HIFU revenue grew 25% when compared to first quarter of
2017
- Ablatherm Fusion 510(k) submission completed
- C-Code reimbursement for HIFU treatments active as of July 1st,
2017
LYON, France, August 23, 2017 -- EDAP TMS SA (Nasdaq: EDAP), the
global leader in therapeutic ultrasound, announced today financial
results for the second quarter ended June 30, 2017, and provided an
update on strategic and operational accomplishments.
"We are incredibly pleased to announce record second quarter
revenue of €9.3 million", said Marc Oczachowski, EDAP's Chief
Executive Officer. "Additionally, the 25% growth in HIFU revenues
compared to the first quarter of 2017 shows a significant return
from our increased sales and marketing efforts. We also submitted
our 510(k) filing to the FDA for our novel Ablatherm Fusion device
recently, and are working to file a new 510(k) application with the
FDA for the Focal One device in the U.S. The addition of these HIFU
devices to our U.S. marketing efforts, coupled with the active
C-Code, should serve to help our customers service the widest
possible range of patients."
Second Quarter 2017 Results
Total revenue for the second quarter 2017 was EUR 9.3 million
(USD 10.4 million), compared to EUR 8.2 million (USD 9.2 million)
for the second quarter of 2016, a 13.7% increase and the highest
second quarter revenue in EDAP's history.
For the three months ended June 30, 2017, total revenue for the
Lithotripsy division was EUR 6.4 million (USD 7.2 million), a 33.9%
increase compared to EUR 4.8 million (USD 5.4 million) during the
year-ago period. During the second quarter of 2017, EDAP sold 7
lithotripsy devices compared to 6 lithotripsy devices sold during
the second quarter of 2016.
Total revenue in the HIFU business for the second quarter was
EUR 2.9 million (USD 3.2 million) compared to EUR 3.4 million (USD
3.8 million) for the second quarter of 2016. During the second
quarter of 2017, EDAP sold 1 Focal One and 2 Ablatherm HIFU devices
compared to 1 Focal One and 3 Ablatherm devices during the second
quarter of 2016.
Gross profit for the second quarter 2017 was EUR 4.0 million
(USD 4.5 million), compared to EUR 3.5 million (USD 3.9 million)
for the year-ago period. Gross profit margin on net sales expanded
to 43.2% in the second quarter of 2017, compared to 42.2% in the
prior year period, primarily due to increase in revenues.
Operating expenses for the second quarter of 2017 totaled EUR
4.4 million (USD 5.0 million) for the second quarter of 2017,
compared to EUR 3.8 million (USD 4.3 million) for the same period
in 2016. The increase reflects increased sales and marketing
efforts associated with the expansion of the HIFU and UDS
businesses.
Operating loss for the second quarter of 2017 was EUR 0.4
million (USD 0.5 million), compared to an operating loss of EUR 0.3
million (USD 0.4 million) in the second quarter of 2016.
Net loss for the second quarter of 2017 was EUR 1.7 million (USD
2.0 million), or loss of EUR 0.06 per diluted share, as compared to
net income of EUR 2.5 million (USD 2.8 million), or earnings of EUR
0.09 per diluted share in the year-ago period. Net loss during the
second quarter of 2017 included a non-cash interest expense of EUR
0.6 million (USD $0.6 million) to adjust the accounting fair value
of the outstanding warrants.
First Six Months 2017 Results
Total revenue for the first half of 2017 was EUR 18.0 million
(USD 19.7 million) - a new record level for the period, up 6.3%
compared to EUR 16.9 million (USD 18.8 million) for the first half
of 2016.For the six months ended June 30, 2017, total revenue for
the Lithotripsy division was EUR 12.8 million (USD 14.0 million),
an increase of 24.6% when compared to EUR 10.2 million (USD 11.4
million), during the year ago period. This increase was driven by
growth in both the distribution business and lithotripsy device
sales. Total revenue in the HIFU division for the first six months
2017 was EUR 5.2 million (USD 5.7 million) compared to EUR 6.7
million (USD 7.4 million) for the six months ended June 30, 2016.
This decrease was primarily due to slow U.S. sales of HIFU devices
during the first half of the year, tempered by an increase in HIFU
treatment driven revenues. Gross profit for the first half of 2017
was EUR 7.6 million (USD 8.3 million) and gross profit margin was
42.1%, compared to 45.8% in the year ago period. The contraction in
gross profit margin was primarily due to an unfavorable mix of HIFU
and UDS segment revenues. The Company recorded an operating loss
for the first half of 2017 of EUR 0.8 million (USD 0.9 million),
compared with an operating profit of EUR 0.4 million (USD 0.4
million) in the first six months of 2016. Net loss for the first
half of 2017 was EUR 0.1 million (USD 0.1 million), or EUR 0.00 per
diluted share, as compared to a net income of EUR 3.9 million (USD
4.3 million), or EUR 0.14 per diluted share, in the first half of
2016. Net income for the first six months of 2017 included non-cash
interest income of EUR 1.4 million (USD 1.5 million) to adjust the
accounting fair value of the outstanding warrants At June 30, 2017,
cash and cash equivalents, including short-term treasury
investments, were EUR 18.6 million (USD 21.2 million).
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 9:00 AM ET, on Thursday,
August 24, 2017. Please refer to the information below for
conference call dial-in information and webcast registration.
Conference Date: Thursday, August 24, 2017, 9:00 AM
ETConference dial-in: 877-269-7756International
dial-in: 201-689-7817Conference Call
Name: EDAP-TMS Second Quarter 2017 Results Conference
CallWebcast 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 (UNAUDITED)(Amounts in thousands of
Euros and U.S. Dollars, except per share data)
Three
Months Ended:
Three
Months Ended:
|
June 30,2017Euros |
|
June 30,2016Euros |
|
June 30,2017$US |
|
June 30,2016$US |
Net sales of goods Net sales of RPP and Leases |
5,966 1,304 |
|
5,262 1,316 |
|
6,670 1,458 |
|
5,896 1,474 |
|
Net sales of spare parts andServices |
2,037 |
|
1,611 |
|
2,277 |
|
1,805 |
|
TOTAL NET SALES |
9,307 |
|
8,189 |
|
10,405 |
|
9,174 |
|
Other revenues |
13 |
|
8 |
|
15 |
|
9 |
|
TOTAL REVENUES |
9,320 |
|
8,197 |
|
10,420 |
|
9,183 |
|
Cost of sales |
(5,304) |
|
(4,736) |
|
(5,931) |
|
(5,305) |
|
GROSS PROFIT |
4,016 |
|
3,461 |
|
4,489 |
|
3,878 |
|
Research & development expenses |
(969) |
|
(887) |
|
(1,083) |
|
(993) |
|
S, G & A expenses |
(3,477) |
|
(2,919) |
|
(3,887) |
|
(3,271) |
|
Total operating expenses |
(4,446) |
|
(3,806) |
|
(4,970) |
|
(4,264) |
|
OPERATING PROFIT (LOSS) |
(430) |
|
(345) |
|
(481) |
|
(386) |
|
Interest (expense) income, net |
(575) |
|
2,412 |
|
(643) |
|
2,702 |
|
Currency exchange gains (loss), net |
(625) |
|
483 |
|
(699) |
|
541 |
|
Other income (loss), net |
- |
|
- |
|
- |
|
- |
|
INCOME (LOSS) BEFORE TAXES AND MINORITY
INTEREST |
(1,630) |
|
2,550 |
|
(1,823) |
|
2,857 |
|
Income tax (expense) credit |
(117) |
|
(52) |
|
(130) |
|
(58) |
|
NET INCOME (LOSS)
|
(1,747) |
|
2,498 |
|
(1,953) |
|
2,799 |
|
Basic income (loss) per share |
(0.06) |
|
0.09 |
|
(0.07) |
|
0.109 |
|
Basic weighted average shares outstanding |
28,997,866 |
|
28,288,307 |
|
28,997,866 |
|
28,288,307 |
|
Diluted income (loss) per share |
(0.06) |
|
0.08 |
|
(0.07) |
|
0.09 |
|
Diluted weighted average shares outstanding |
28,997,866 |
|
29,826,117 |
|
28,997,866 |
|
29,826,117 |
|
NOTE: Translated for convenience of the reader to
U.S. dollars at the 2017 average three months' noon buying rate of
1 Euro = 1.1181USD, and 2016 average three months' noon buying rate
of 1 Euro = 1.1203 USD.
EDAP TMS S.A.CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED)(Amounts in thousands of
Euros and U.S. Dollars, except per share data)
Six
Months Ended:
Six
Months Ended:
|
June 30,2017Euros |
|
June 30, 2016Euros |
|
June 30, 2017$US |
|
June 30,2016$US |
Net sales of goods Net sales of RPP and leases |
11,478 2,599 |
|
11,261 2,578 |
|
12,559 2,844 |
|
12,518 2,865 |
|
Net sales of spare parts andServices |
3,879 |
|
3,078 |
|
4,244 |
|
3,421 |
|
TOTAL NET SALES |
17,956 |
|
16,917 |
|
19,647 |
|
18,805 |
|
Other revenues |
40 |
|
8 |
|
43 |
|
9 |
|
TOTAL REVENUES |
17,996 |
|
16,925 |
|
19,690 |
|
18,813 |
|
Cost of sales |
(10,427) |
|
(9,171) |
|
(11,410) |
|
(10,195) |
|
GROSS PROFIT |
7,569 |
|
7,754 |
|
8,280 |
|
8,618 |
|
Research & development expenses |
(1,865) |
|
(1,701) |
|
(2,040) |
|
(1,890) |
|
S, G & A expenses |
(6,551) |
|
(5,665) |
|
(7,169) |
|
(6,296) |
|
Total operating expenses |
(8,416) |
|
(7,366) |
|
(9,209) |
|
(8,186) |
|
OPERATING PROFIT (LOSS) |
(847) |
|
388 |
|
(929) |
|
432 |
|
Interest (expense) income, net |
1,408 |
|
2,891 |
|
1,541 |
|
3,213 |
|
Currency exchange gains (loss), net |
(450) |
|
671 |
|
(492) |
|
746 |
|
Other income (loss), net |
- |
|
- |
|
- |
|
- |
|
INCOME (LOSS) BEFORE TAXES AND MINORITY
INTEREST |
111 |
|
3,950 |
|
120 |
|
4,391 |
|
Income tax (expense) credit |
(175) |
|
(91) |
|
(191) |
|
(101) |
|
NET INCOME (LOSS)
|
(64) |
|
3,859 |
|
(71) |
|
4,290 |
|
Basic income (loss) per share |
(0.00) |
|
0.14 |
|
(0.00) |
|
0.16 |
|
Basic weighted average shares outstanding |
28,919,984 |
|
26,844,696 |
|
28,919,984 |
|
26,844,696 |
|
Diluted income (loss) per share |
(0.00) |
|
0.13 |
|
(0.00) |
|
0.15 |
|
Diluted weighted average shares outstanding |
28,919,984 |
|
28,615,172 |
|
28,919,984 |
|
28,615,172 |
|
NOTE: Translated for convenience of the reader to
U.S. dollars at the 2017 average six months' noon buying rate of 1
Euro = 1.0942USD, and 2016 average six months' noon buying rate of
1 Euro = 1. 1116 USD.
EDAP TMS S.A.CONSOLIDATED BALANCE
SHEETS HIGHLIGHTS(Amounts in thousands of Euros and U.S.
Dollars)
|
June 30, 2017 Euros |
|
Mar. 31, 2017
Euros |
|
June 30, 2017 $US |
|
Mar. 31, 2017 $US |
|
Cash,
cash equivalents and short term investments |
18,554 |
|
|
20,321 |
21,173 |
21,739 |
|
|
|
Total
current assets |
39,583 |
|
|
40,542 |
45,171 |
43,370 |
|
|
|
Total
current liabilities |
13,372 |
|
|
14,052 |
15,260 |
15,032 |
|
|
|
Shareholders' Equity |
25,383 |
|
|
26,904 |
28,966 |
28,780 |
|
|
|
NOTE: Translated for convenience of the reader to
U.S. dollars at the noon buying rate of 1 Euro = 1.1412 USD, on
June 30, 2017 and at the noon buying rate of 1 Euro = 1.0697 USD,
on March 31, 2017.
EDAP TMS S.A.CONDENSED STATEMENTS OF
OPERATIONS BY DIVISIONSIX MONTHS ENDED JUNE 30,
2017(Amounts in thousands of Euros)
|
|
HIFU Division |
|
UDS Division |
|
|
Corporate |
|
Total After Consolidation |
|
Sales of goods |
2,626 |
|
8,852 |
|
|
|
|
11,478 |
|
Sales of RPPs & leases |
1,898 |
|
700 |
|
|
|
|
2,599 |
|
Sales of spare parts & services |
696 |
|
3,183 |
|
|
|
|
3,879 |
|
TOTAL NET SALES |
5,220 |
|
12,735 |
|
|
|
|
17,956 |
|
Other revenues |
8 |
|
32 |
|
|
|
|
40 |
|
TOTAL REVENUES |
5,228 |
|
12,767 |
|
|
|
|
17,996 |
|
GROSS PROFIT(% of Total Revenues) |
2,794 |
53% |
4,774 |
37% |
|
|
|
7,569 |
42% |
|
|
|
|
|
|
|
|
|
|
Research & Development |
(1,211) |
|
(653) |
|
|
|
|
(1,865) |
|
Total SG&A plus depreciation |
(2,467) |
|
(3,315) |
|
|
(768) |
|
(6,551) |
|
OPERATING PROFIT (LOSS) |
(884) |
|
804 |
|
|
(768) |
|
(847) |
|
ContactBlandine ConfortInvestor Relations
/ Legal AffairsEDAP TMS SA+33 4 72 15 31
72bconfort@edap-tms.com
InvestorsRich CockrellCG
CAPITAL877.889.1972investorrelations@cg.capital
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