EDAP TMS Reports Third Quarter 2017 Results
- EDAP's HIFU patient treatment revenues grew 29% compared to
third quarter 2016.
- EDAP received FDA clearance for its Ablatherm Fusion® late
in the quarter.
- EDAP's cash position remains strong at US $21.3 million on
September 30, 2017
LYON, France, November 15, 2017 -- EDAP TMS SA (Nasdaq: EDAP),
the global leader in therapeutic ultrasound, today announced
financial results for the third quarter ended September 30, 2017
and an update on strategic and operational accomplishments.
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "Our
team has executed another successful quarter. Physicians
and patients are clearly responding to the advantages of HIFU for
prostate cancer as evidenced by our 29% growth in treatment driven
revenues compared to the third quarter of 2016."
"EDAP received clearance for the Ablatherm Fusion late in the
quarter. Our current Ablatherm users are initiating the upgrade
process, excited for the increased accuracy provided by Ablatherm
Fusion's proprietary imaging software. In the meantime, we continue
to work with the FDA for the clearance of Focal One®."
Third Quarter 2017 Results
Total revenue for the third quarter of 2017 was EUR 7.1 million
(USD 8.4 million), compared to EUR 8.0 million (USD 8.9 million)
for the third quarter of 2016.
For the three months ended September 30, 2017, total revenue for
the Lithotripsy division was EUR 5.3 million (USD 6.3 million),
compared to EUR 5.4 million (USD 6.1 million) during the year-ago
period. During the third quarter of 2017, EDAP sold 6 lithotripsy
devices compared to 11 lithotripsy devices sold during the third
quarter of 2016.
Total revenue in the HIFU business for the third quarter was EUR
1.8 million (USD 2.2 million) compared to EUR 2.5 million (USD 2.8
million) for the third quarter of 2016. During the third quarter of
2017, EDAP sold no HIFU devices compared to 2 Focal One devices
during the third quarter of 2016.
Gross profit for the third quarter of 2017 was EUR 2.8 million
(USD 3.3 million), compared to EUR 3.5 million (USD 3.9 million)
for the year-ago period. Gross profit margin on net sales
was 39.4% in the third quarter of 2017, compared to 43.2% in
the prior year period, primarily due to a lower revenue.
Operating expenses for the third quarter of 2017 totaled EUR 3.8
million (USD 4.5 million) for the third quarter of 2017, compared
to EUR 3.8 million (USD 4.2 million) for the same period in
2016.
Operating loss for the third quarter of 2017 was EUR 1.0 million
(USD 1.2 million), compared to an operating loss of EUR 0.3 million
(USD 0.4 million) in the third quarter of 2016. '
Net loss for the third quarter of 2017 was EUR 0.5 million (USD
0.6 million), or loss of EUR 0.02 per diluted share, as compared to
net income of EUR 1.3 million (USD 1.4 million), or earnings of EUR
0.04 per diluted share in the year-ago period. Net loss during the
third quarter of 2017 included a non-cash interest income of EUR
0.8 million to adjust the accounting fair value of the outstanding
warrants
First Nine Months 2017 Results
Total revenue for the first nine months of 2017 was EUR 25.1
million (USD 28.2 million) up 1% compared to 24.9 million (USD 27.8
million) during the first nine months of 2016.
For the nine months ended September 30, 2017, total revenue for
the Lithotripsy division was EUR 18.1 million (USD 20.3 million), a
growth of 15% compared to EUR 15.7 million (USD 17.5 million).
During the first nine months of 2017 EDAP sold 21 Lithotripsy
devices compared to 27 Lithotripsy devices during the year ago
period.
HIFU revenue for the nine months ended September 30, 2017 was
EUR 7.1 (USD 7.9 million) compared to EUR 9.2 million (USD 10.3
million) during the first nine months of 2016. During the first
nine months of 2017, EDAP sold 4 HIFU devices, compared to 10 HIFU
devices sold during the first nine months of 2016.
Gross profit for the first nine months of 2017 was EUR 10.4
million (USD 11.7 million) and gross profit margin on net sales was
41.4% compared to EUR 11.2 million (USD 12.5 million) and gross
profit margin of 45.0% during the first nine months of 2016.
Operating loss for the first nine months of 2017 was EUR 1.8
million (USD 2.1 million) compared to an operating profit of EUR
0.1 million (USD 0.1 million) during the same period of
2016.
Net loss for the first nine months of 2017 was EUR 0.6 million
(USD 0.7 million), or loss of EUR 0.02 per share (USD 0.02),
compared to net income of EUR 5.1 million (USD 5.7 million), or
earnings of EUR 0.18 (USD 0.20) per share during the first nine
months of 2016. Net loss for the first nine months of 2017 included
non-cash interest income of EUR 2.2 million to adjust the
accounting fair value of the outstanding warrants.
As of September 30, 2017, cash and cash equivalents, including
short-term treasury investments, were EUR 18.0 million (USD 21.3
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 review
the results. The call will be held at 8:30 AM ET, on Thursday,
November 16, 2017. Please refer to the information below for
conference call dial-in information and webcast registration.
Conference Date: Thursday, November 16, 2017, 8:30 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: EDAP-TMS Third Quarter 2017 Results
Conference 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, next generation of Ablatherm device
is now FDA cleared. 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. In addition, the Company 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-prostate.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.
Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors
Rich Cockrell
CG Capital
877.889.1972
rich@cg.capital
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, 2017 Euros |
|
September 30, 2016 Euros |
|
September 30, 2017 $US |
|
September 30, 2016 $US |
| Net
sales of goods Net sales of RPP and Leases |
3,889 1,277 |
|
5,218 1,098 |
|
4,606 1,512 |
|
5,836 1,228 |
| Net
sales of spare parts andServices |
1,955 |
|
1,674 |
|
2,316 |
|
1,873 |
|
TOTAL NET SALES |
7,121 |
|
7,990 |
|
8,434 |
|
8,936 |
| Other
revenues |
4 |
|
2 |
|
4 |
|
2 |
|
TOTAL REVENUES |
7,124 |
|
7,992 |
|
8,438 |
|
8,938 |
| Cost
of sales |
(4,317) |
|
(4,537) |
|
(5,114) |
|
(5,075) |
|
GROSS PROFIT |
2,807 |
|
3,454 |
|
3,324 |
|
3,864 |
|
Research & development expenses |
(918) |
|
(1,032) |
|
(1,087) |
|
(1,154) |
| S, G
& A expenses |
(2,889) |
|
(2,754) |
|
(3,422) |
|
(3,080) |
| Total
operating expenses |
(3,807) |
|
(3,786) |
|
(4,510) |
|
(4,234) |
|
OPERATING PROFIT (LOSS) |
(1,001) |
|
(332) |
|
(1,185) |
|
(371) |
|
Interest (expense) income, net |
821 |
|
1,502 |
|
972 |
|
1,680 |
|
Currency exchange gains (loss), net |
(325) |
|
130 |
|
(385) |
|
145 |
| Other
income (loss), net |
- |
|
- |
|
- |
|
- |
|
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST |
(504) |
|
1,301 |
|
(597) |
|
1,455 |
| Income
tax (expense) credit |
(21) |
|
(40) |
|
(25) |
|
(44) |
| NET
INCOME (LOSS)
|
(525) |
|
1,261 |
|
(622) |
|
1,411 |
| Basic
income (loss) per share |
(0.02) |
|
0.04 |
|
(0.02) |
|
0.05 |
| Basic
weighted average shares outstanding |
28,997,866 |
|
28,727,616 |
|
28,997,866 |
|
28,727,616 |
|
Diluted income (loss) per share |
(0.02) |
|
0.04 |
|
(0.02) |
|
0.05 |
|
Diluted weighted average shares outstanding |
28,997,866 |
|
30,251,966 |
|
28,997,866 |
|
30,251,966 |
NOTE: Translated for convenience of the reader to
U.S. dollars at the 2017 average three months' noon buying rate of
1 Euro = 1.1844USD, and 2016 average three months' noon buying rate
of 1 Euro = 1.1184 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, 2017 Euros |
|
September 30, 2016 Euros |
|
September 30, 2017 $US |
|
September 30, 2016 $US |
| Net
sales of goods Net sales of RPP and leases |
15,367 3,876 |
|
16,480 3,675 |
|
17,276 4,357 |
|
18,356 4,094 |
| Net
sales of spare parts andServices |
5,834 |
|
4,752 |
|
6,559 |
|
5,293 |
|
TOTAL NET SALES |
25,076 |
|
24,907 |
|
28,192 |
|
27,742 |
| Other
revenues |
43 |
|
10 |
|
48 |
|
11 |
|
TOTAL REVENUES |
25,119 |
|
24,917 |
|
28,240 |
|
27,753 |
| Cost
of sales |
(14,745) |
|
(13,709) |
|
(16,576) |
|
(15,269) |
|
GROSS PROFIT |
10,375 |
|
11,208 |
|
11,663 |
|
12,484 |
|
Research & development expenses |
(2,783) |
|
(2,733) |
|
(3,129) |
|
(3,044) |
| S, G
& A expenses |
(9,441) |
|
(8,418) |
|
(10,614) |
|
(9,376) |
| Total
operating expenses |
(12,224) |
|
(11,151) |
|
(13,742) |
|
(12,420) |
|
OPERATING PROFIT (LOSS) |
(1,849) |
|
57 |
|
(2,079) |
|
63 |
|
Interest (expense) income, net |
2,229 |
|
4,393 |
|
2,506 |
|
4,893 |
|
Currency exchange gains (loss), net |
(775) |
|
801 |
|
(871) |
|
892 |
| Other
income (loss), net |
- |
|
- |
|
- |
|
(1) |
|
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST |
(394) |
|
5,250 |
|
(443) |
|
5,848 |
| Income
tax (expense) credit |
(196) |
|
(130) |
|
(220) |
|
(145) |
| NET
INCOME (LOSS)
|
(590) |
|
5,120 |
|
(663) |
|
5,703 |
| Basic
income (loss) per share |
(0.02) |
|
0.19 |
|
(0.02) |
|
0.21 |
| Basic
weighted average shares outstanding |
28,947,947 |
|
27,497,107 |
|
28,947,947 |
|
27,497,107 |
|
Diluted income (loss) per share |
(0.02) |
|
0.18 |
|
(0.02) |
|
0.20 |
|
Diluted weighted average shares outstanding |
28,947,947 |
|
29,045,939 |
|
28,947,947 |
|
29,045,939 |
NOTE: Translated for convenience of the reader to
U.S. dollars at the 2017 average six months' noon buying rate of 1
Euro = 1.1242USD, and 2016 average six months' noon buying rate of
1 Euro = 1. 1138 USD.
EDAP TMS S.A.CONSOLIDATED BALANCE
SHEETS HIGHLIGHTS(Amounts in thousands of Euros and U.S.
Dollars)
|
|
Sept. 30, 2017 Euros |
|
June 30, 2017 Euros |
|
Sept. 30, 2017 $US |
|
June 30, 2017 $US |
|
|
|
|
|
|
|
|
|
| Cash,
cash equivalents and short term investments |
18,036 |
|
18,554 |
|
21,306 |
|
21,173 |
| Total
current assets |
37,172 |
|
39,583 |
|
43,912 |
|
45,171 |
| Total
current liabilities |
12,676 |
|
13,372 |
|
14,975 |
|
15,260 |
|
Shareholders' Equity |
24,947 |
|
25,383 |
|
29,471 |
|
28,966 |
NOTE: Translated for convenience of the reader to
U.S. dollars at the noon buying rate of 1 Euro = 1.1813 USD, on
September 30, 2017 and at the noon buying rate of 1 Euro = 1.1412
USD, on June 30, 2017.
EDAP TMS S.A.CONDENSED STATEMENTS OF
OPERATIONS BY DIVISIONNINE MONTHS ENDED SEPTEMBER 30,
2017(Amounts in thousands of Euros)
| |
HIFU Division |
|
UDS Division |
|
Corporate |
|
Total After Consolidation |
|
|
Sales of goods |
3,109 |
|
12,258 |
|
|
|
15,367 |
|
| Sales
of RPPs & leases |
2,891 |
|
984 |
|
|
|
3,876 |
|
| Sales
of spare parts & services |
1,050 |
|
4,784 |
|
|
|
5,834 |
|
|
TOTAL NET SALES |
7,050 |
|
18,026 |
|
|
|
25,076 |
|
| Other
revenues |
8 |
|
35 |
|
|
|
43 |
|
|
TOTAL REVENUES |
7,058 |
|
18,062 |
|
|
|
25,119 |
|
|
GROSS PROFIT(% of Total Revenues) |
3,621 |
51% |
6,754 |
37% |
|
|
10,375 |
41% |
|
|
|
|
|
|
|
|
|
|
|
Research & Development |
(1,814) |
|
(969) |
|
|
|
(2,783) |
|
| Total
SG&A plus depreciation |
(3,627) |
|
(4,711) |
|
(1,103) |
|
(9,441) |
|
|
OPERATING PROFIT (LOSS) |
(1,820) |
|
1,074 |
|
(1,103) |
|
(1,849) |
|
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