EDAP Reports 69% Growth in HIFU Revenues and Operating Profit for First Half 2016
EDAP Reports 69% Growth in HIFU Revenues and Operating Profit for First Half 2016
- Total EDAP revenue up 20.4% year-over-year in the first six months of 2016
- Continued growth in HIFU system sales and treatment-driven revenue with strong margins
- Focal One® 510k under
FDA review - Solid cash position at €21.9 million as of
June 30, 2016
"The solid performance of the HIFU division, in which revenues increased 69% over the first half of 2015, is clear evidence that our market penetration strategy is working and supports the expansion and growth of our global HIFU business. We continue penetrating the U.S. market with our strategy of targeting large and recognized institutions directly, while also providing access to the entire urology community by partnering with mobilizers and service providers.
In April, we submitted a 510(k) application for our next generation Focal One® HIFU system with the
Second Quarter 2016 Results
Total revenue for the second quarter 2016
was EUR 8.2 million (
Total revenue in the HIFU business for this quarter was
For the three months ended
Gross profit for the second quarter 2016 was
Operating expenses were
Operating loss for the second quarter 2016 was
Net income for the second quarter 2016 was
First Six Months 2016 Results
Total revenue for the first half of 2016 was EUR 16.9 million (
Total revenue in the HIFU division for the first six months 2016 was
For the six months ended
Gross profit for the first half of 2016 was EUR 7.8 million (
Operating expenses were
The Company recorded an operating profit the first half of 2016 of EUR 0.4 million (
Net income for the first half of 2016 was EUR 3.9 million (
At June 30, 2016, cash and cash equivalents, including short-term treasury investments, were EUR 21.9 million (
Conference Call
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After the live event, the webcast will remain available on EDAP's website, www.edap-tms.com, through
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||||||
(Amounts in thousands of Euros and | ||||||||||||
Three Months Ended: | Three Months Ended: | |||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||
Euros | Euros | $US | $US | |||||||||
Sales of goods | 5,262 | 5,357 | 5,896 | 5,948 | ||||||||
1,316 | 1,090 | 1,474 | 1,210 | |||||||||
Sales of spare parts and | ||||||||||||
Services | 1,611 | 1,388 | 1,805 | 1,541 | ||||||||
TOTAL | 8,189 | 7,834 | 9,174 | 8,699 | ||||||||
Other revenues | 8 | 2 | 9 | 2 | ||||||||
TOTAL REVENUES | 8,197 | 7,836 | 9,183 | 8,701 | ||||||||
Cost of goods | (2,768 | ) | (2,996 | ) | (3,101 | ) | (3,327 | ) | ||||
Cost of RPP and Leases | (805 | ) | (648 | ) | (902 | ) | (720 | ) | ||||
Cost of spare parts & services | (1,162 | ) | (861 | ) | (1,302 | ) | (956 | ) | ||||
Cost of sales | (4,736 | ) | (4,505 | ) | (5,305 | ) | (5,002 | ) | ||||
GROSS PROFIT | 3,461 | 3,331 | 3,878 | 3,699 | ||||||||
Research & development expenses | (887 | ) | (739 | ) | (993 | ) | (820 | ) | ||||
Marketing & Sales expenses | (2,147 | ) | (1,859 | ) | (2,406 | ) | (2,064 | ) | ||||
G & A expenses | (772 | ) | (950 | ) | (865 | ) | (1,055 | ) | ||||
Total operating expenses | (3,806 | ) | (3,548 | ) | (4,264 | ) | (3,940 | ) | ||||
OPERATING PROFIT (LOSS) | (345 | ) | (217 | ) | (386 | ) | (241 | ) | ||||
Interest (expense) income, net | 2,412 | 1,005 | 2,702 | 1,116 | ||||||||
Currency exchange gains (loss), net | 483 | (262 | ) | 541 | (291 | ) | ||||||
Other income (loss), net | - | - | - | - | ||||||||
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST | 2,550 | 526 | 2,857 | 584 | ||||||||
Income tax (expense) credit | (52 | ) | (39 | ) | (58 | ) | (43 | ) | ||||
NET INCOME (LOSS) | 2,498 | 487 | 2,799 | 541 | ||||||||
Earning per share - Basic | 0.09 | 0.02 | 0.109 | 0.02 | ||||||||
Average number of shares used in computation of Basic EPS | 28,288,307 | 24,958,174 | 28,288,307 | 24,958,174 | ||||||||
Earning per share - Diluted | 0.08 | 0.02 | 0.09 | 0.02 | ||||||||
Average number of shares used in computation of Diluted EPS | 29,826,117 | 27,016,460 | 29,826,117 | 27,016,460 | ||||||||
NOTE: Translated for convenience of the reader to |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||||||
(Amounts in thousands of Euros and | ||||||||||||
Six Months Ended: | Six Months Ended: | |||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||
Euros | Euros | $US | $US | |||||||||
Sales of goods | 11,261 | 9,103 | 12,518 | 10,095 | ||||||||
2,578 | 2,119 | 2,865 | 2,350 | |||||||||
Sales of spare parts and | ||||||||||||
Services | 3,078 | 2,830 | 3,421 | 3,138 | ||||||||
TOTAL | 16,917 | 14,052 | 18,805 | 15,584 | ||||||||
Other revenues | 8 | 2 | 9 | 2 | ||||||||
TOTAL REVENUES | 16,925 | 14,054 | 18,814 | 15,586 | ||||||||
Cost of goods | (5,561 | ) | (5,042 | ) | (6,182 | ) | (5,591 | ) | ||||
Cost of RPP and Leases | (1,513 | ) | (1,292 | ) | (1,681 | ) | (1,433 | ) | ||||
Cost of spare parts & services | (2,097 | ) | (1,809 | ) | (2,332 | ) | (2,006 | ) | ||||
Cost of sales | (9,171 | ) | (8,143 | ) | (10,195 | ) | (9,030 | ) | ||||
GROSS PROFIT | 7,753 | 5,911 | 8,619 | 6,556 | ||||||||
Research & development expenses | (1,701 | ) | (1,512 | ) | (1,890 | ) | (1,677 | ) | ||||
Marketing & Sales expenses | (4,013 | ) | (3,408 | ) | (4,460 | ) | (3,780 | ) | ||||
G & A expenses | (1,652 | ) | (1,830 | ) | (1,836 | ) | (2,030 | ) | ||||
Total operating expenses | (7,365 | ) | (6,750 | ) | (8,187 | ) | (7,486 | ) | ||||
OPERATING PROFIT (LOSS) | 388 | (839 | ) | 432 | (931 | ) | ||||||
Interest (expense) income, net | 2,891 | (1,344 | ) | 3,213 | (1,491 | ) | ||||||
Currency exchange gains (loss), net | 671 | 303 | 746 | 336 | ||||||||
Other income (loss), net | - | (3 | ) | - | (3 | ) | ||||||
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST | 3,950 | (1,884 | ) | 4,391 | (2,089 | ) | ||||||
Income tax (expense) credit | (91 | ) | (69 | ) | (101 | ) | (77 | ) | ||||
NET INCOME (LOSS) | 3,859 | (1,953 | ) | 4,289 | (2,166 | ) | ||||||
Earning per share - Basic | 0.14 | (0.08 | ) | 0.16 | (0.09 | ) | ||||||
Average number of shares used in computation of Basic EPS | 26,844,696 | 24,926,627 | 26,844,696 | 24,926,627 | ||||||||
Earning per share - Diluted | 0.13 | (0.08 | ) | 0.15 | (0.09 | ) | ||||||
Average number of shares used in computation of Diluted EPS | 28,615,172 | 24,926,627 | 28,615,172 | 24,926,627 | ||||||||
NOTE: Translated for convenience of the reader to |
CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (Amounts in thousands of Euros and | |||||||||
Mar. 31, | Mar. 31, | ||||||||
2016 | 2016 | 2016 | 2016 | ||||||
Euros | Euros | $US | $US | ||||||
Cash, cash equivalents and short term investments | 21,940 | 14,533 | 24,203 | 16,552 | |||||
Total current assets | 40,963 | 33,019 | 45,188 | 37,607 | |||||
Total current liabilities | 14,817 | 16,529 | 16,345 | 18,826 | |||||
Shareholders' Equity | 24,358 | 15,901 | 26,870 | 18,111 | |||||
NOTE: Translated for convenience of the reader to and at the noon buying rate of |
CONDENSED STATEMENTS OF OPERATIONS BY DIVISION | |||||||||||||||||||||
SIX MONTHS ENDED | |||||||||||||||||||||
(Amounts in thousands of Euros) | |||||||||||||||||||||
HIFU Division | UDS Division | FDA Trials | Corporate | Total After Consolidation | |||||||||||||||||
Sales of goods | 4,536 | 6,725 | 11,261 | ||||||||||||||||||
Sales of RPPs & Leases | 1,811 | 766 | 2,578 | ||||||||||||||||||
Sales of spare parts & services | 328 | 2,750 | 3,078 | ||||||||||||||||||
TOTAL | 6,676 | 10,241 | 16,917 | ||||||||||||||||||
Other revenues | 6 | 2 | 8 | ||||||||||||||||||
TOTAL REVENUES | 6,682 | 10,243 | 16,925 | ||||||||||||||||||
GROSS PROFIT | 4,081 | 61 | % | 3,672 | 36 | % | 7,753 | 46 | % | ||||||||||||
(% of Total Revenues) | |||||||||||||||||||||
Research & Development | (1,048 | ) | (653 | ) | - | (1,701 | ) | ||||||||||||||
Total SG&A plus depreciation | (1,979 | ) | (2,996 | ) | (689 | ) | (5,664 | ) | |||||||||||||
- | |||||||||||||||||||||
OPERATING PROFIT (LOSS) | 1,054 | 23 | (689 | ) | 388 | ||||||||||||||||
Contact:Source:Blandine Confort Investor Relations / Legal AffairsEDAP 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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