UNITED STATES
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 29, 2018
Commission File Number: 0-29374
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 29, 2018
EDAP TMS S.A.
/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER
Exhibit 99.1
EDAP Reports 2018 Second Quarter Results
| · | Receives FDA clearance for novel Focal One device for prostate tissue ablation |
LYON, France, August 29, 2018 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in therapeutic ultrasound, announced today financial results for the second quarter of 2018 and provided a strategic and operational update. Management will host a conference call on Thursday, August 30th at 8:30 ET.
Marc Oczachowski, EDAP's Chief Executive Officer, said: “During the second quarter, we achieved a significant milestone with the FDA clearance of our Focal One device for the targeted ablation of prostate tissue. With its exclusive Dynamic Focusing Technology, combined with unique imaging and diagnostic features, we believe Focal One is superior to currently available HIFU devices, and represents a leap forward in the minimally invasive management of prostate tissue ablation. We have already commenced marketing this novel HIFU technology to the urology community, and look forward to providing further updates on our sales momentum on future calls.”
First Six Months 2018 Results
Total revenue for the first half of 2018 was EUR 17.8 million (USD 21.4 million), a 1.3% decrease compared to EUR 18.0 million (USD 19.7 million) for the first half of 2017.
Total revenue in the HIFU division for the first six months 2018 was EUR 4.8 million (USD 5.7 million) compared to EUR 5.2 million (USD 5.7 million) for the six months ended June 30, 2017.
For the six months ended June 30, 2018, total revenue for the Lithotripsy division was EUR 13.0 million (USD 15.7 million), a 1.9% increase compared to EUR 12.8 million (USD 14.0 million), during the year ago period.
Gross profit for the first half of 2018 was EUR 7.6 million (USD 9.1 million) and gross profit margin was 42.6%, compared to 42.1%
in the year ago period.
Operating expenses were EUR 9.0 million (USD 10.9 million) for the first six months of 2018, compared to EUR 8.4 million (USD 9.2 million) for the same period in 2017.
The Company recorded an operating loss for the
first half of 2018 of EUR 1.5 million (USD 1.8 million), compared with an operating loss of EUR 0.8 million (USD 0.9 million) in
the first six months of 2017.
Net loss for the first half of 2018 was EUR
0.7 million (USD 0.8 million), or a loss of EUR 0.02 per diluted share, as compared to a net loss of EUR 0.1 million (USD 0.1 million),
or EUR 0.00 per diluted share, in the first half of 2017. Net loss for the first six months of 2018 included non-cash interest
income of EUR 0.5 million (USD 0.6 million) to adjust the accounting fair value of the outstanding warrants
Second Quarter 2018 Results
Total revenue for the second quarter 2018 was EUR 8.6 million (USD 10.2 million), a 7.7% decrease compared to EUR 9.3 million (USD 10.4 million) for the second quarter of 2017.
Total revenue in the HIFU business for the second quarter 2018 was EUR 2.3 million (USD 2.7 million), a 20.2% decline compared to EUR 2.9 million (USD 3.2 million) for the second quarter of 2017.
For the three months ended June 30, 2018, total revenue for the Lithotripsy division was EUR 6.3 (USD 7.4 million), a 2.0% decrease compared to EUR 6.4 million (USD 7.2 million) during the prior year period.
Gross profit for the second quarter 2018 was EUR 3.6 million (USD 4.2 million), compared to EUR 4.0 million (USD 4.5 million) for the year-ago period. Gross profit margin on net sales was 41.3% in the second quarter of 2018, compared to 43.2% in the second quarter of 2017.
Operating expenses were EUR 4.6 million (USD 5.5 million) for the second quarter of 2018, compared to EUR 4.4 million (USD 5.0 million) for the same period in 2017.
Operating loss for the second quarter 2018 was EUR 1.1 million (USD 1.3 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the second quarter of 2017.
Net loss for the second quarter 2018 was EUR 0.8 million (USD 0.9 million), or a loss of EUR 0.03 per diluted share, as compared to a net loss of EUR 1.7 million (USD 2.0 million), or a loss of EUR 0.06 per diluted share in the year-ago period.
At June 30, 2018, cash and cash equivalents, including short-term treasury investments, were EUR 17.2 million (USD 20.7 million).
Conference Call
An accompanying conference call will be conducted by Philippe Chauveau, Chairman of the Board; Marc Oczachowski, Chief Executive Officer; and François Dietsch, Chief Financial Officer, to review the results. The call will be held at 8:30 AM ET, on Thursday August 30, 2018. Please refer to the information below for conference call dial-in information and webcast registration.
Conference Call & Webcast
Thursday, August 30, 2018 @ 8:30am Eastern Time
| Domestic: | 800-239-9838 | |
| International | 323-794-2551 | |
| Passcode: | 9816635 | |
| Webcast: | http://public.viavid.com/index.php?id=130698 | |
Replays, Available through September 13, 2018:
| Domestic: | 844-512-2921 | |
| International: | 412-317-6671 | |
| Replay PIN: | 9816635 |
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
A recognized leader in the global therapeutic ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for urology using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in 2013 in Europe and in 2018 in the U.S. as the answer to all requirements for ideal prostate tissue ablation as a complement to the existing FDA-cleared Ablatherm® Robotic HIFU and Ablatherm® Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively utilizes the latest generation of shock wave source in its Sonolith® range of ESWL systems. For more information on the Company, please visit http://www.edap-tms.com, and us.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 50
bconfort@edap-tms.com
Investor Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of Euros and U.S. Dollars, except per share data)
| Three Months Ended: | Three Months Ended: | |||||||||||||||
| June 30, 2018 Euros | June 30, 2017 Euros | June 30, 2018 $US | June 30, 2017 $US | |||||||||||||
| Sales of goods | 5,178 | 5,966 | 6,114 | 6,670 | ||||||||||||
| Net Sales of RPP and Leases | 1,270 | 1,304 | 1,500 | 1,458 | ||||||||||||
| Sales of spare parts, supplies and Services | 2,141 | 2,037 | 2,528 | 2,277 | ||||||||||||
| TOTAL NET SALES | 8,590 | 9,307 | 10,141 | 10,405 | ||||||||||||
| Other revenues | 14 | 13 | 17 | 15 | ||||||||||||
| TOTAL REVENUES | 8,604 | 9,320 | 10,158 | 10,420 | ||||||||||||
| Cost of sales | (5,053 | ) | (5,304 | ) | (5,966 | ) | (5,931 | ) | ||||||||
| GROSS PROFIT | 3,550 | 4,016 | 4,191 | 4,489 | ||||||||||||
| Research & development expenses | (1,199 | ) | (969 | ) | (1,416 | ) | (1,083 | ) | ||||||||
| S, G & A expenses | (3,431 | ) | (3,477 | ) | (4,050 | ) | (3,887 | ) | ||||||||
| Total operating expenses | (4.630 | ) | (4,446 | ) | (5,466 | ) | (4,970 | ) | ||||||||
| OPERATING PROFIT (LOSS) | (1,080 | ) | (430 | ) | (1,275 | ) | (481 | ) | ||||||||
| Interest (expense) income, net | (111 | ) | (575 | ) | (131 | ) | (643 | ) | ||||||||
| Currency exchange gains (loss), net | 470 | (625 | ) | 555 | (699 | ) | ||||||||||
| INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST | (721 | ) | (1,630 | ) | (851 | ) | (1,823 | ) | ||||||||
| Income tax (expense) credit | (46 | ) | (117 | ) | (55 | ) | (130 | ) | ||||||||
| NET INCOME (LOSS) | (767 | ) | (1,747 | ) | (906 | ) | (1,953 | ) | ||||||||
| Earning per share – Basic | (0.03 | ) | (0.06 | ) | (0.03 | ) | (0.07 | ) | ||||||||
| Average number of shares used in computation of EPS | 28,997,866 | 28,997,866 | 28,997,866 | 28,997,866 | ||||||||||||
| Earning per share – Diluted | (0.03 | ) | (0.06 | ) | (0.03 | ) | (0.07 | ) | ||||||||
| Average number of shares used in computation of EPS for positive net income | 28,997,866 | 28,997,866 | 28,997,866 | 28,997,866 | ||||||||||||
NOTE: Translated for convenience of the reader to U.S. dollars at the 2018 average three months’ noon buying rate of 1 Euro = 1.1806 USD, and 2017 average three months noon buying rate of 1 Euro = 1.1181USD.
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of Euros and U.S. Dollars, except per share data)
| Six Months Ended: | Six Months Ended: | |||||||||||||||
| June 30, 2018 Euros | June 30, 2017 Euros | June 30, 2018 $US | June 30, 2017 $US | |||||||||||||
| Sales of goods | 10,929 | 11,478 | 13,184 | 12,559 | ||||||||||||
| Net Sales of RPP and Leases | 2,480 | 2,599 | 2,992 | 2,844 | ||||||||||||
| Sales of spare parts, supplies and Services | 4,338 | 3,879 | 5,233 | 4,244 | ||||||||||||
| TOTAL NET SALES | 17,748 | 17,956 | 21,409 | 19,647 | ||||||||||||
| Other revenues | 14 | 40 | 17 | 43 | ||||||||||||
| TOTAL REVENUES | 17,762 | 17,996 | 21,426 | 19,690 | ||||||||||||
| Cost of sales | (10,201 | ) | (10,427 | ) | (12,305 | ) | (11,410 | ) | ||||||||
| GROSS PROFIT | 7,561 | 7,569 | 9,121 | 8,280 | ||||||||||||
| Research & development expenses | (2,200 | ) | (1,865 | ) | (2,653 | ) | (2,040 | ) | ||||||||
| S, G & A expenses | (6,843 | ) | (6,551 | ) | (8,255 | ) | (7,169 | ) | ||||||||
| Total operating expenses | (9,043 | ) | (8,416 | ) | (10,908 | ) | (9,209 | ) | ||||||||
| OPERATING PROFIT (LOSS) | (1,482 | ) | (847 | ) | (1,787 | ) | (929 | ) | ||||||||
| Interest (expense) income, net | 528 | 1,408 | 637 | 1,541 | ||||||||||||
| Currency exchange gains (loss), net | 456 | (450 | ) | 550 | (492 | ) | ||||||||||
| INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST | (498 | ) | 111 | (601 | ) | 120 | ||||||||||
| Income tax (expense) credit | (180 | ) | (175 | ) | (218 | ) | (191 | ) | ||||||||
| NET INCOME (LOSS) | (679 | ) | (64 | ) | (819 | ) | (71 | ) | ||||||||
| Earning per share – Basic | (0.02 | ) | (0.00 | ) | (0.03 | ) | (0.00 | ) | ||||||||
| Average number of shares used in computation of EPS | 28,997,866 | 28,919,984 | 28,997,866 | 28,919,984 | ||||||||||||
| Earning per share – Diluted | (0.02 | ) | (0.00 | ) | (0.03 | ) | (0.00 | ) | ||||||||
| Average number of shares used in computation of EPS for positive net income | 28,997,866 | 28,919,984 | 28,997,866 | 28,919,984 | ||||||||||||
NOTE: Translated for convenience of the reader to U.S. dollars at the 2018 average six months’ noon buying rate of 1 Euro = 1.2063 USD, and 2017 average six months noon buying rate of 1 Euro = 1.0942 USD.
EDAP TMS S.A.
UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS
(Amounts in thousands of Euros and U.S. Dollars)
| June 30, 2018 Euros | Mar. 31, 2018 Euros | June 31, 2018 $US | Mar. 31, 2018 $US | |||||||||||||
| Cash, cash equivalents and short term investments | 17,203 | 18,142 | 20,087 | 22,351 | ||||||||||||
| Total current assets | 38,535 | 37,734 | 44,997 | 46,687 | ||||||||||||
| Total current liabilities | 16,016 | 13,843 | 18,702 | 17,054 | ||||||||||||
| Shareholders’ Equity | 24,535 | 25,439 | 28,648 | 31,340 | ||||||||||||
NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1677 USD, on June 30, 2018 and at the noon buying rate of 1 Euro = 1.2320 USD, on March 31, 2018.
EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
SIX MONTHS ENDED JUNE 30, 2018
(Amounts in thousands of Euros)
| HIFU Division | UDS Division | Corporate | Total After Consolidation | |||||||||||||||||||||||
| Sales of goods | 2,082 | 8,848 | 10,929 | |||||||||||||||||||||||
| Sales of RPPs & Leases | 1,791 | 689 | 2,480 | |||||||||||||||||||||||
| Sales of spare parts & services | 870 | 3,469 | 4,338 | |||||||||||||||||||||||
| TOTAL NET SALES | 4,742 | 13,006 | 17,748 | |||||||||||||||||||||||
| Other revenues | 14 | - | 14 | |||||||||||||||||||||||
| TOTAL REVENUES | 4,756 | 13,006 | 17,762 | |||||||||||||||||||||||
| GROSS PROFIT (% of Total Revenues) | 2,326 | 48.9 | % | 5,236 | 40.3 | % | 7,561 | 42.6% | ||||||||||||||||||
| Research & Development | (1,437 | ) | (763 | ) | (2,200 | ) | ||||||||||||||||||||
| Total SG&A plus depreciation | (2,798 | ) | (3,405 | ) | (640 | ) | (6,843 | ) | ||||||||||||||||||
| OPERATING PROFIT (LOSS) | (1,909 | ) | 1,068 | (640 | ) | (1,482 | ) | |||||||||||||||||||