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 DIVISION
TWELVE 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 Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investor Contact:
Rich Cockrell
CG Capital
877-889-1972
investorrelations@cg.capital