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
For the month of November 2008.
Commission File Number: 333-136811
EDAP TMS S.A.
(Translation of registrant's name into English)
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France
(Address of principal executive office)
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): ____
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
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): ____
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes [ ] No [ ]
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-____.
On November 20, 2008 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
(c) Exhibit 99.1. Press release dated November 20, 2008
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.
| EDAP TMS S.A. (Registrant) |
||
| Date: November 20, 2008 | /s/ MARC OCZACHOWSKI MARC OCZACHOWSKI CHIEF EXECUTIVE OFFICER |
EXHIBIT 99.1
EDAP Reports Third Quarter 2008 Financial Results
Third Quarter 2008 Highlights: ------------------------------ * Cash position of EUR 14.1 million (USD 19.8 million) supporting growth initiatives * Total HIFU revenue of EUR 1.9 million (USD 2.8 million), up 16.7% sequentially * Gross profit of EUR 2.0 million (USD 2.9 million), up 8.8% over third quarter 2007 * Gross margin increased to 43.8% compared to 39.2% in third quarter 2007 * Robust backlog of three Ablatherm-HIFU and twelve lithotripsy devices
LYON, France, Nov. 20, 2008 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today financial results for the third quarter ended September 30, 2008.
For the third quarter 2008, total revenue was EUR 4.6 million (USD 6.8 million), compared to EUR 4.7 million (USD 6.5 million) for the same period in 2007. Total revenue for the third quarter 2008 reflected the anticipated seasonality for HIFU device sales and return of lithotripsy sales to expected normalized levels over the period.
Total revenue for the Company's HIFU division was EUR 1.9 million in the third quarter 2008 (USD 2.8 million), flat from the same period in 2007 and up 16.7% sequentially. For the nine months ended September 30, 2008, the Company sold a total of three Ablatherm-HIFU systems, equivalent to the number of HIFU devices sold during the same period of last year. At the beginning of the fourth quarter 2008, the Company had a backlog of three machines and is actively developing a strong pipeline of projects for the end of the year.
Total revenue for the Company's lithotripsy division was EUR 2.7 million (USD 3.9 million) in the third quarter 2008, compared to EUR 2.8 million (USD 3.9 million) for the same period last year. In the third quarter 2008, the Company sold a total of seven machines, including one Sonolith I-Sys device. Two additional lithotripsy machines were delivered in September but will be recognized in the Company's October 2008 sales period in compliance with accounting rules. The Company converted a portion of its second quarter 2008 backlog into revenue during the third quarter of 2008 while returning to normalized machine sales as anticipated following a strong second quarter 2008. At the beginning of the fourth quarter 2008, the Company had a backlog of twelve lithotripsy machines, including six Sonolith I-sys devices.
Gross profit for the third quarter 2008 was EUR 2.0 million (USD 2.9 million), compared to EUR 1.8 million (USD 2.5 million) for the third quarter 2007. Gross profit margin increased to 43.8% in the third quarter 2008, up from 39.5% in the third quarter 2007 due to improved margins in the lithotripsy business and a more favorable mix of machine sales.
Operating expenses of EUR 3.3 million (USD 4.9 million) in the third quarter 2008 were flat from the third quarter 2007. Third quarter 2008 operating expenses included EUR 0.6 million related to the U.S. FDA ENLIGHT clinical trial for Ablatherm. For the nine months ended September 30, 2008, total operating expenses decreased EUR 0.2 million, or 2.7%, excluding U.S. clinical trial expenses. Operating loss was EUR 4.3 million for the nine months ended September 30, 2008, compared to an operating loss of EUR 3.3 million for same period of 2007. The year-over-year increase in operating loss was primarily attributed to the EUR 0.8 million increase in U.S. clinical trials expenses.
The net loss for the third quarter 2008 was EUR 4.0 million, or EUR 0.43 per diluted share, compared to a net loss of EUR 1.4 million, or EUR 0.16 per diluted share, in 2007. The third quarter 2008 net loss included a non-cash financial charge of EUR 2.5 million reflecting the adjustment of the Company's convertible preferred debt and outstanding warrants to fair value.
Cash and cash equivalents, including short-term treasury investments, were EUR 14.1 million (USD 19.8 million) at September 30, 2008, up 5.2% sequentially. The positive cash flow for the third quarter of 2008 is primarily attributed to improved working capital requirements and the currency valuation of the U.S. dollar against the Euro. For the nine months ended September 30, 2008, the Company's cash burn was EUR 4.5 million, including EUR 1.6 million for the U.S. FDA clinical trials.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "Entering the fourth quarter, we are encouraged by the expected return of capital equipment sales from our robust pipeline of projects. We are pleased with the increased order flow and momentum achieved in our backlog of three Ablatherm and twelve lithotripsy devices thus far and are confident the substantial volume will represent a significant increase in fourth quarter 2008 sales. EDAP remains focused on increasing the awareness and adoption of our entire product portfolio through the continuation of aggressive sales and marketing initiatives."
Mr. Oczachowski continued, "Given today's challenging economic environment, EDAP's cash position allows us to continue investing in the Company's overall growth by furthering our key strategic objectives to expand HIFU in Europe, successfully complete our U.S. ENLIGHT clinical trial, and develop our deep project pipeline. Our cash resources and differentiated technology provide EDAP with a competitive advantage that gives us confidence that we will continue to move forward despite the broader market's instability."
Separately, EDAP announced that Hugues de Bantel has resigned from the Company's Board of Directors to pursue other interests.
Philippe Chauveau, EDAP's Chairman of the Board, said, "We appreciate the dedication that Hugues has provided to EDAP over his twelve-year tenure at the Company. We thank him for his contributions and wish him the best in his future endeavors."
Conference Call
EDAP will hold a conference call on Thursday, November 20, 2008 at 8:00 a.m. ET to discuss the results. The dial-in numbers are 1-888-241-0558 for domestic callers and 1-647-427-3417 for international. The conference ID number for both is 71345056. A live webcast of the conference call will be available online from the investor relations page of the Company's new corporate Website at www.edap-tms.com.
After the live webcast, the call will remain available on EDAP's Website, www.edap-tms.com, through February 20, 2009. In addition, a telephonic replay of the call will be available until December 4, 2008. The replay dial-in numbers are 1-800-374-7921 for domestic callers and 1-402-220-0879 for international callers. Please use event ID number 71345056.
About EDAP TMS SA
EDAP TMS SA develops and markets Ablatherm, the most advanced and clinically proven choice for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. 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. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA. The Company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotrip sy (ESWL). For more information on the company, please visit http://www.edap-tms.com, http://www.hifu-planet.com and http://www.pcaresearch.com or http://www.urotoday.com/HIFU.
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:
------------------- -------------------
Sept. 30, Sept. 30, Sept. 30, Sept. 30,
2008 2007 2008 2007
Euros Euros $US $US
Sales of goods 2,218 2,268 3,279 3,142
Net Sales of RPP and Leases 1,003 1,005 1,482 1,393
Sales of spare parts and
Services 1,309 1,380 1,935 1,912
--------- --------- --------- ---------
TOTAL NET SALES 4,530 4,653 6,696 6,448
Other revenues 38 33 56 45
--------- --------- --------- ---------
TOTAL REVENUES 4,568 4,686 6,752 6,493
--------- --------- --------- ---------
Cost of goods (1,369) (1,354) (2,023) (1,877)
Cost of RPP and Leases (556) (486) (822) (673)
Cost of spare parts &
services (660) (1,023) (975) (1,417)
--------- --------- --------- ---------
Cost of sales (2,585) (2,863) (3,820) (3,967)
--------- --------- --------- ---------
GROSS PROFIT 1,984 1,823 2,932 2,526
Research & development
expenses (1,012) (761) (1,496) (1,055)
Marketing & Sales expenses (1,317) (1,273) (1,947) (1,763)
G & A expenses (988) (1,143) (1,460) (1,584)
Non-recurring profit /
(expenses) -- (136) -- (188)
--------- --------- --------- ---------
Total operating expenses (3,318) (3,313) (4,903) (4,589)
OPERATING PROFIT (LOSS) (1,334) (1,489) (1,971) (2,063)
Interest (expense) income,
net (2,871) 5 (4,243) 6
Currency exchange gains
(loss), net 305 11 451 15
Other income (loss), net (4) 3 (6) 4
--------- --------- --------- ---------
INCOME (LOSS) BEFORE TAXES
AND MINORITY INTEREST (3,904) (1,471) (5,770) (2,038)
Income tax (expense) credit (88) 25 (129) 34
--------- --------- --------- ---------
NET INCOME (3,992) (1,446) (5,900) (2,003)
(LOSS)
========= ========= ========= =========
Earning per share - Basic (0.43) (0.16) (0.63) (0.22)
Average number of shares
used in computation of
EPS 9,356,372 9,163,007 9,356,372 9,163,007
Earning per share - Diluted (0.43) (0.16) (0.63) (0.22)
Average number of shares
used in computation of
EPS for positive net
income 9,432,074 9,519,169 9,432,074 9,519,169
NOTE: Translated for convenience of the reader to U.S. dollars at the
2008 average three months noon buying rate of 1 Euro = 1.4780 USD, and
2007 average three months noon buying rate of 1 Euro = 1.3857 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:
------------------ ------------------
Sept. 30, Sept. 30, Sept. 30, Sept. 30,
2008 2007 2008 2007
Euros Euros $US $US
Sales of goods 6,461 7,430 9,839 10,056
Net Sales of
RPP and Leases 3,317 3,576 5,051 4,840
Sales of spare
parts and
Services 4,126 4,210 6,282 5,698
---------- ---------- ---------- ----------
TOTAL NET SALES 13,904 15,217 21,172 20,594
Other revenues 130 82 197 111
---------- ---------- ---------- ----------
TOTAL REVENUES 14,033 15,299 21,369 20,706
---------- ---------- ---------- ----------
Cost of goods (4,216) (4,713) (6,419) (6,378)
Cost of RPP and
Leases (1,759) (1,603) (2,679) (2,170)
Cost of spare
parts &
services (2,245) (2,820) (3,418) (3,817)
---------- ---------- ---------- ----------
Cost of sales (8,220) (9,136) (12,516) (12,364)
---------- ---------- ---------- ----------
GROSS PROFIT 5,814 6,163 8,853 8,341
Research &
development
expenses (3,099) (2,320) (4,720) (3,140)
Marketing &
Sales expenses (3,997) (3,935) (6,086) (5,326)
G & A expenses (2,991) (3,561) (4,554) (4,819)
Non-recurring
profit /
(expenses) -- 306 -- 414
---------- ---------- ---------- ----------
Total operating
expenses (10,087) (9,511) (15,361) (12,872)
OPERATING PROFIT
(LOSS) (4,274) (3,348) (6,508) (4,531)
Interest
(expense)
income, net 1,941 11 2,955 15
Currency
exchange gains
(loss), net 239 (217) 364 (294)
Other income
(loss), net 4 14 6 20
---------- ---------- ---------- ----------
INCOME (LOSS)
BEFORE TAXES
AND MINORITY
INTEREST (2,090) (3,539) (3,183) (4,790)
Income tax
(expense)
credit 97 148 147 201
---------- ---------- ---------- ----------
NET INCOME
(LOSS) (1,994) (3,391) (3,036) (4,589)
========== ========== ========== ==========
Earning per
share - Basic (0.21) (0.37) (0.32) (0.50)
Average number
of shares used
in computation
of EPS 9,356,372 9,163,007 9,356,372 9,163,007
Earning per
share -
Diluted (0.21) (0.37) (0.32) (0.50)
Average number
of shares used
in computation
of EPS for
positive net
income 9,432,074 9,528,936 9,432,074 9,528,936
NOTE: Translated for convenience of the reader to U.S. dollars at the
2008 average nine months noon buying rate of 1 Euro = 1.5228 USD, and
2007 average nine months noon buying rate of 1 Euro = 1.3534 USD.
EDAP TMS S.A.
CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (UNAUDITED)
(Amounts in thousands of Euros and U.S. Dollars)
September 30, June 30, September 30, June 30,
2008 2008 2008 2008
Euros Euros $US $US
Cash, cash
equivalents and
short term
investments 14,072 13,406 19,815 21,112
Total current
assets 32,094 31,061 44,534 48,176
Total current
liabilities 12,321 11,580 17,349 18,236
Shareholders'
Equity 13,106 16,758 18,454 26,391
NOTE: Translated for convenience of the reader to U.S. dollars at the
noon buying rate of 1 Euro = 1.4081 USD, on September 30, 2008 and at
the noon buying rate of 1 Euro = 1.5748 USD, on June 30, 2008.
EDAP TMS S.A.
CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
NINE MONTHS ENDED SEPTEMBER 30, 2008
(Amounts in thousands of Euros)
HIFU UDS FDA Corporate Total After
Division Division Trials Consoli-
dation
Sales of goods 1,916 4,545 6,461
Sales of RPPs &
Leases 2,582 735 3,317
Sales of spare
parts &
services 1,183 2,943 4,126
------- ------- ------- ------- -------
TOTAL NET SALES 5,681 8,223 13,904
------- ------- ------- ------- -------
Other revenues 97 32 130
------- ------- ------- ------- -------
TOTAL REVENUES 5,778 8,255 14,033
------- ------- ------- ------- -------
GROSS PROFIT 3,411 60% 2,403 29% 5,814 42%
Research &
Development (817) (771) (1,512) (3,099)
Total SG&A plus
depreciation (2,689) (2,709) (81) (1,509) (6,988)
------- ------- ------- ------- -------
OPERATING PROFIT
(LOSS) (95) (1,077) (1,592) (1,509) (4,274)
CONTACT: EDAP TMS SA
Investor Relations / Legal Affairs
Blandine Confort
+33 4 72 15 31 72
bconfort@edap-tms.com
The Ruth Group
Investors:
R.J. Pellegrino
646-536-7009
rpellegrino@theruthgroup.com