SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
August 26, 2015
Commission File Number: 000-29374
EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ x] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: August 26, 2015
EDAP TMS S.A.
/s/ MARC OCZACHOWSKI
MARC OCZACHOWSKI
CHIEF EXECUTIVE OFFICER
EXHIBIT 99.1
EDAP Reports Strong Year-over-Year Revenue Growth in Second Quarter 2015
- Second quarter 2015 revenue increased 39% year-over-year to EUR 7.8 million (USD 8.7 million)
- Second Quarter 2015 HIFU revenues increased 55% year-over-year
- Strong and increased cash position at €11.8 Million on June 30, 2015.
- Formal complete response to recent FDA Letter submitted on Friday, August 21, 2015
- First Focal One® Device sold in Italy
- Recorded sale of Focal One® at prominent MediPôle Partenaires Hospital Group in France
LYON, France, Aug. 26, 2015 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced financial results for the second quarter ended June 30, 2015 and provided an update on recent strategic developments.
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "In the second quarter, we achieved solid year-over-year revenue growth in both our HIFU and Lithotripsy divisions, which led the Company to near breakeven on an operational basis. This is rewarding to see how close we are to breakeven, without being yet in the US with HIFU."
Mr. Oczachowski added, "As we announced previously, we received FDA comments ('Deficiency List') to our Direct De Novo 510(k) petition in July, and we are proud to say that, as we anticipated, we have provided all formal responses in a timely manner. We are excited about this further progress in the process with FDA and continue to closely work on the file with the Agency."
Second Quarter 2015 Results
Total revenue for the second quarter 2015 was EUR 7.8 million (USD 8.7 million), a 39.1% year-over-year increase compared to EUR 5.6 million (USD 7.7 million) for the second quarter 2014.
Total revenue in the HIFU business for this quarter was EUR 2.3 million (USD 2.6 million) compared to EUR 1.5 million (USD 2.1 million) for the second quarter 2014. HIFU revenue included the sale of two Focal One systems.
For the three months ended June 30, 2015, total revenue for the Lithotripsy division was EUR 5.5 million (USD 6.1 million), compared to EUR 4.1 million (USD 5.7 million), during the year ago period.
Gross profit for the first quarter 2015 was EUR 3.3 million (USD 3.7 million), compared to EUR 1.8 million (USD 2.5 million) for the year ago period. Gross profit margin on net sales was 42.5% in the second quarter of 2015, compared to 32.0% in the year ago period.
Operating expenses were EUR 3.6 million (USD 3.9 million) for the second quarter 2015, compared to EUR 3.4 million (USD 4.7 million) for the same period in 2014.
Operating loss for the second quarter 2015 was EUR 0.2 million (USD 0.2 million), compared with EUR 1.6 million (USD 2.2 million) in the second quarter of 2014.
Net income for the second quarter 2015 was EUR 0.5 million (USD 0.5 million), or EUR 0.02 per diluted share, as compared to a net loss of EUR 5.3 million (USD 7.2 million), or EUR 0.23 per diluted share, in the year ago period. Net income in the second quarter of 2015 included non-cash interest income of EUR 1.0 million to adjust the accounting fair value of the outstanding warrants.
First Six Months 2015 Results
Total revenue for the first half of 2015 was EUR 14.1 million (USD 15.6 million), up 4.9% compared to EUR 13.4 million (USD 18.0 million) for the first half of 2014.
Gross profit for the first half of 2015 was EUR 5.9 million (USD 6.6 million) and gross profit margin was 42.1%, compared to 40.1 % in the year ago period.
Operating loss for the first half of 2015 was EUR 0.8 million (USD 0.9 million), an improvement of EUR 0.2 million from EUR 1.0 million (USD 1.4 million) in the first six months of 2014.
Net loss for the first half of 2015 was EUR 2.0 million (USD 2.2 million), or EUR 0.08 per diluted share, as compared to net loss of EUR 4.4 million (USD 5.9 million), or EUR 0.20 per diluted share, in the first half of 2014. Net loss in the first half of 2015 included a non-cash interest expense of EUR 1.3 million to adjust the accounting fair value of the outstanding warrants.
At June 30, 2015, cash and cash equivalents, including short-term treasury investments, were EUR 11.8 million (USD 13.2 million).
Conference Call
EDAP will hold a conference call on August 27, 2015 at 8:30 am. 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 10071254. 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 September 23, 2015. In addition, a dial-in replay of the call will be available until September 3, 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 10071254.
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: | |||
|
June 30, 2015 Euros |
June 30, 2014 Euros |
June 30, 2015 $US |
June 30, 2014 $US |
|
| Sales of goods | 5,357 | 3,342 | 5,948 | 4,589 |
| Net Sales of RPP and Leases | 1,090 | 1,024 | 1,210 | 1,407 |
|
Sales of spare parts and Services |
1,388 |
1,269 |
1,541 |
1,743 |
| TOTAL NET SALES | 7,834 | 5,635 | 8,699 | 7,738 |
| Other revenues | 2 | (3) | 2 | (4) |
| TOTAL REVENUES | 7,836 | 5,632 | 8,701 | 7,734 |
| Cost of goods | (2,996) | (2,344) | (3,327) | (3,219) |
| Cost of RPP and Leases | (648) | (636) | (720) | (874) |
| Cost of spare parts & services | (861) | (849) | (956) | (1,166) |
| Cost of sales | (4,505) | (3,829) | (5,002) | (5,258) |
| GROSS PROFIT | 3,331 | 1,803 | 3,699 | 2,476 |
| Research & development expenses | (739) | (932) | (820) | (1,279) |
| Marketing & Sales expenses | (1,859) | (1,623) | (2,064) | (2,228) |
| G & A expenses | (950) | (853) | (1,055) | (1,171) |
| Total operating expenses | (3,548) | (3,407) | (3,940) | (4,679) |
| OPERATING PROFIT (LOSS) | (217) | (1,604) | (241) | (2,203) |
| Interest (expense) income, net | 1,005 | (3,814) | 1,116 | (5,237) |
| Currency exchange gains (loss), net | (262) | 161 | (291) | 221 |
| Other income (loss), net | -- | (1) | -- | (2) |
| INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST | 526 | (5,259) | 584 | (7,222) |
| Income tax (expense) credit | (39) | (7) | (43) | (9) |
| NET INCOME (LOSS) | 487 | (5,265) | 541 | (7,231) |
| Earning per share – Basic | 0.02 | (0.23) | 0.02 | (0.32) |
| Average number of shares used in computation of Basic EPS | 24,958,174 | 22,756,337 | 24,958,174 | 22,756,337 |
| Earning per share – Diluted | 0.02 | (0.23) | 0.02 | (0.32) |
|
Average number of shares used in computation of Diluted EPS |
27,016,460 | 22,756,337 | 27,016,460 | 22,756,337 |
|
NOTE: Translated for convenience of the reader to U.S. dollars at the 2015 average three months noon buying rate of 1 Euro = 1.1104 USD, and 2014 average three months noon buying rate of 1 Euro = 1.3732 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, 2015 Euros |
June 30, 2014 Euros |
June 30, 2015 $US |
June 30, 2014 $US |
|
| Sales of goods | 9,103 | 8,756 | 10,095 | 11,769 |
| Net Sales of RPP and Leases | 2,119 | 2,023 | 2,350 | 2,719 |
|
Sales of spare parts and Services |
2,830 |
2,618 |
3,138 |
3,519 |
| TOTAL NET SALES | 14,052 | 13,397 | 15,584 | 18,006 |
| Other revenues | 2 | -- | 2 | -- |
| TOTAL REVENUES | 14,054 | 13,397 | 15,586 | 18,006 |
| Cost of goods | (5,042) | (5,159) | (5,591) | (6,934) |
| Cost of RPP and Leases | (1,292) | (1,141) | (1,433) | (1,534) |
| Cost of spare parts & services | (1,809) | (1,730) | (2,006) | (2,325) |
| Cost of sales | (8,143) | (8,030) | (9,030) | (10,793) |
| GROSS PROFIT | 5,911 | 5,367 | 6,556 | 7,214 |
| Research & development expenses | (1,512) | (1,618) | (1,677) | (2,174) |
| Marketing & Sales expenses | (3,408) | (3,064) | (3,780) | (4,118) |
| G & A expenses | (1,830) | (1,732) | (2,030) | (2,328) |
| Total operating expenses | (6,750) | (6,413) | (7,486) | (8,620) |
| OPERATING PROFIT (LOSS) | (839) | (1,046) | (931) | (1,406) |
| Interest (expense) income, net | (1,344) | (3,554) | (1,491) | (4,778) |
| Currency exchange gains (loss), net | 303 | 216 | 336 | 290 |
| Other income (loss), net | (3) | (4) | (3) | (6) |
| INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST | (1,884) | (4,389) | (2,089) | (5,899) |
| Income tax (expense) credit | (69) | (36) | (77) | (49) |
| NET INCOME (LOSS) | (1,953) | (4,425) | (2,166) | (5,948) |
| Earning per share – Basic | (0.08) | (0.20) | (0.09) | (0.27) |
| Average number of shares used in computation of Basic EPS | 24,926,627 | 22,273,003 | 24,926,627 | 22,273,003 |
| Earning per share – Diluted | (0.08) | (0.20) | (0.09) | (0.27) |
| Average number of shares used in computation of Diluted EPS | 24,926,627 | 22,273,003 | 24,926,627 | 22,273,003 |
|
NOTE: Translated for convenience of the reader to U.S. dollars at the 2015 average six months noon buying rate of 1 Euro = 1.1090 USD, and 2014 average six months noon buying rate of 1 Euro = 1. 3441USD. |
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| EDAP TMS S.A. | ||||
| CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (Amounts in thousands of Euros and U.S. Dollars) | ||||
|
June 30, 2015 Euros |
Mar. 31, 2015 Euros |
June 30, 2015 $US |
Mar. 31, 2015 $US |
|
| Cash, cash equivalents and short term investments | 11,851 | 11,285 | 13,219 | 12,121 |
| Total current assets | 28,442 | 26,792 | 31,725 | 28,778 |
| Total current liabilities | 13,942 | 12,021 | 15,552 | 12,912 |
| Shareholders' Equity | 13,383 | 12,829 | 14,928 | 13,780 |
| NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1154 USD, on June 30, 2015 and at the noon buying rate of 1 Euro = 1.0741 USD, on March 31, 2015. | ||||
| EDAP TMS S.A. | ||||||||||
| CONDENSED STATEMENTS OF OPERATIONS BY DIVISION | ||||||||||
| SIX MONTHS ENDED JUNE 30, 2015 | ||||||||||
| (Amounts in thousands of Euros) | ||||||||||
|
HIFU Division |
UDS Division |
FDA Trials |
Corporate |
Total After Consolidation |
||||||
|
Sales of goods |
2,318 |
6,785 |
9,103 |
|||||||
| Sales of RPPs & Leases | 1,297 | 822 | 2,119 | |||||||
| Sales of spare parts & services | 333 | 2,497 | 2,830 | |||||||
| TOTAL NET SALES | 3,948 | 10,104 | 14,052 | |||||||
| Other revenues | 2 | -- | 2 | |||||||
| TOTAL REVENUES | 3,950 | 10,104 | 14,054 | |||||||
| GROSS PROFIT | 2,158 | 55% | 3,753 | 37% | 5,911 | 42% | ||||
| (% of Total Revenues) | ||||||||||
| Research & Development | (745) | (455) | (312) | (1,512) | ||||||
| Total SG&A plus depreciation | (1,504) | (3,014) | (721) | (5,238) | ||||||
| OPERATING PROFIT (LOSS) | (91) | 284 | (312) | (721) | (839) | |||||
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