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
EDAP TMS S.A. Files on
March 31, 2009
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 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 [ x ]
This report on Form 6-K is hereby incorporated by reference in the registration statement of EDAP TMS S.A. on Forms F-3, file number 333-136811 and 333-147762.
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: March 31, 2009
EDAP TMS S.A.
/s/ MARC OCZACHOWSKI
MARC OCZACHOWSKI
CHIEF EXECUTIVE OFFICER
EXHIBIT 99.1
EDAP Reports Fourth Quarter and Full Year 2008 Financial Results
Fourth Quarter 2008 Highlights: * Record revenue of EUR 9.0 million, up 28.4% year-over-year and up 95.7% sequentially * Ablatherm-HIFU RPP treatments increased 31.9% year-over-year * Total HIFU revenue of EUR 3.4 million, up 13.9% year-over-year and up 79.5% sequentially * Total Lithotripsy revenue of EUR 5.6 million, up 39.2% year-over- year and up 110.2% sequentially * Robust cash position of EUR 15.0 million (USD 20.8 million)
LYON, France, March 31, 2009 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today financial results for the fourth quarter and full year ended December 31, 2008.
2008 Fourth Quarter Financial Results
For the fourth quarter 2008, the Company reported total revenue of EUR 9.0 million (USD 11.8 million), a 28.4% increase from EUR 7.0 million (USD 10.3 million) for the same period in 2007. Total revenue for the fourth quarter 2008 confirmed the anticipated conversion of the Company's third quarter backlog into equipment sales.
Total revenue for the Company's high intensity focused ultrasound (HIFU) division increased 13.9% to EUR 3.4 million (USD 4.5 million) in the fourth quarter 2008, compared to EUR 3.0 million (USD 4.4 million) in the same period of 2007. The fourth quarter 2008 was the strongest quarter of the year, with a total of four Ablatherm-HIFU systems sold.
Total revenue for the Company's lithotripsy division was EUR 5.6 million (USD 7.3 million) in the fourth quarter 2008, a 39.2% increase from EUR 4.0 million (USD 5.9 million) for the same period last year. The increase resulted from higher machine sales, as twenty-seven devices, including six Sonolith I-Sys systems were sold during the fourth quarter 2008, compared to thirteen machines, including three Sonolith I-Sys devices sold during the year ago period.
Gross profit for the fourth quarter 2008 was EUR 3.3 million (USD 4.3 million), compared to EUR 3.0 million (USD 4.4 million) for the fourth quarter 2007. Gross profit margin was 36.7% in the fourth quarter of 2008 compared to 42.9% in the fourth quarter of 2007 primarily based on a year-over-year increase in sales of lower margin lithotripsy equipment.
Operating expenses decreased to EUR 3.7 million (USD 4.9 million) in the fourth quarter 2008, compared to EUR 3.8 million (USD $5.5 million) for the same period of 2007. Fourth quarter 2008 operating expenses included EUR 0.6 million related to the U.S. FDA ENLIGHT clinical trial for Ablatherm-HIFU. Operating loss was EUR 0.4 million (USD 0.6 million) for the fourth quarter 2008, compared to EUR 0.7 million (USD 1.1 million) for the year ago period. The year-over-year decrease in operating loss reflected higher machine sales in the fourth quarter of 2008.
Net income for the fourth quarter 2008 was EUR 3.6 million (USD 4.7 million), or EUR 0.37 per diluted share, compared to a net loss of EUR 2.0 million (USD 3.0 million), or EUR 0.22 per diluted share in 2007. Fourth quarter 2008 net income included a non-cash gain of EUR 3.5 million, reflecting the adjustment of the Company's convertible preferred debt and outstanding warrants to fair value.
Full Year 2008 Financial Results
For the full year ended December 31, 2008, total revenue was EUR 23.1 million (USD 33.9 million), compared to EUR 22.3 million (USD 30.8 million) for the full year 2007. Full year 2008 revenue from the HIFU and lithotripsy divisions totaled EUR 9.2 million (USD 13.5 million) and EUR 13.9 million (USD 20.4 million), respectively, compared to EUR 9.3 million (USD 12.9 million) and EUR 13.0 million (USD 17.9 million), respectively, during the full year 2007.
For the twelve months ended December 31, 2008, total operating expenses decreased EUR 0.3 million, or 2.2%, excluding U.S. clinical trial expenses. Operating loss was EUR 4.7 million (USD 6.9 million) for the twelve months ended December 31, 2008, compared to an operating loss of EUR 4.1 million (USD 5.6 million) for same period of 2007. The year-over-year increase in operating loss reflected a EUR 0.8 million increase in U.S. clinical trials expenses and EUR 0.2 million decrease in operating loss excluding the U.S. clinical trials.
Net income for the full year 2008 was EUR 1.6 million (USD 2.3 million), or EUR 0.17 per diluted share, compared to a net loss of EUR 5.4 million (USD 7.5 million) or EUR 0.59 per diluted share for the same period last year. Full year 2008 net income included a non-cash gain of EUR 6.7 million reflecting the adjustment of the Company's convertible preferred debt and outstanding warrants to fair value. As the Company has previously mentioned, uncertain financial market conditions may regularly affect the fair value of our convertible debentures, which may result in significant adjustments in our financial accounts, with no impact on the Company's cash position.
At December 31, 2008, cash and cash equivalents, including short-term treasury investments, were EUR 15.0 million (USD 20.8 million), compared to EUR 14.1 million (USD 19.8 million) at September 30, 2008. For the fourth quarter of 2008, the Company achieved positive cash flow of EUR 0.9 million, including a EUR 0.6 million expense for the U.S. FDA clinical trials. Positive cash flow in the fourth quarter 2008 is primarily due to higher sales in the fourth quarter of this year over the same period in 2007 and the currency valuation of the U.S. dollar against the Euro.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "We are encouraged by the acceleration in machine sales from both our HIFU and lithotripsy divisions, which drove record revenue during the fourth quarter 2008. We are also pleased by the continued order flow into 2009 but we are cautiously optimistic given the current uncertain economic environment. We expect further growth and increased adoption of Ablatherm-HIFU through global expansion into key geographic markets driven by our recent entries into India, Mexico and Brazil. We are also aggressively pursuing our U.S. strategy, which is expected to benefit from the FDA's recent permission to amend our ongoing Ablatherm-HIFU U.S. clinical study to include a broader patient population and additional participating sites."
Mr. Oczachowski continued, "We are confident that our strong cash position and innovative technology places us in a solid position within today's challenging economic climate. As we move forward with our growth initiatives, we plan to continue our prudent cash management to ensure that we remain well-funded to execute our long-term growth strategy."
Conference Call
EDAP will hold a conference call on Tuesday, March 31, 2009 at 8:30 a.m. ET to discuss fourth quarter and full year 2008 financial 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 89881889. 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 Webcast, the call will remain available on EDAP's Website, www.edap-tms.com, through June 30, 2009. In addition, a telephonic replay of the call will be available until April 7, 2009. The replay dial-in numbers are 1-888-214-7699 for domestic callers and 1-402-220-1554 for international callers. Please use event ID number 89881889.
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.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements that involve risks and uncertainties. These include statements regarding the company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved 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:
-------------------- --------------------
Dec. 31, Dec. 31, Dec. 31, Dec. 31,
2008 2007 2008 2007
Euros Euros $US $US
Sales of medical equipment 6,085 4,321 7,971 6,303
Net Sales of RPP and Leases 1,347 1,238 1,764 1,806
Sales of spare parts,
supplies and Services 1,520 1,437 1,991 2,096
--------- --------- --------- ---------
TOTAL NET SALES 8,952 6,997 11,726 10,206
Other revenues 68 31 89 45
--------- --------- --------- ---------
TOTAL REVENUES 9,020 7,028 11,815 10,251
Cost of sales (5,735) (4,012) (7,512) (5,852)
--------- --------- --------- ---------
GROSS PROFIT 3,285 3,016 4,303 4,399
Research & development
expenses (1,156) (874) (1,514) (1,275)
S, G & A expenses (2,559) (2,354) (3,351) (3,432)
Non-recurring operating
expenses (529) (772)
--------- --------- --------- ---------
Total operating expenses (3,715) (3,757) (4,865) (5,479)
OPERATING PROFIT (LOSS) (429) (741) (562) (1,081)
Interest (expense) income,
net 3,292 (1,254) 4,311 (1,830)
Currency exchange gains
(loss), net 338 (37) 443 (54)
Other income (loss), net (5) 1 (7) 2
--------- --------- --------- ---------
INCOME (LOSS) BEFORE TAXES
AND MINORITY INTEREST 3,195 (2,031) 4,185 (2,963)
Income tax (expense) credit 396 (8) 519 (12)
--------- --------- --------- ---------
NET INCOME (LOSS) 3,591 (2,040) 4,703 (2,975)
========= ========= ========= =========
Earning per share - Basic 0.37 (0.22) 0.49 (0.32)
Average number of shares
used in computation
of EPS 9,582,593 9,200,757 9,582,593 9,200,757
Earning per share - Diluted 0.37 (0.22) 0.49 (0.32)
Average number of shares
used in computation of
EPS for positive net
income 9,589,658 9,455,092 9,589,658 9,455,092
NOTE: Translated for convenience of the reader to U.S. dollars at the
2008 average three months noon buying rate of 1 Euro = 1.3098USD, and
2007 average three months noon buying rate of 1 Euro = 1.4586 USD.
EDAP TMS S.A.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands of Euros and U.S. Dollars,
except per share data)
Twelve Months Ended: Twelve Months Ended:
-------------------- --------------------
Dec. 31, Dec. 31, Dec. 31, Dec. 31,
2008 2007 2008 2007
Euros Euros $US $US
Sales of medical equipment 12,547 11,752 18,438 16,214
Net Sales of RPP and Leases 4,664 4,814 6,854 6,642
Sales of spare parts,
supplies and Services 5,645 5,647 8,296 7,792
--------- --------- --------- ---------
TOTAL NET SALES 22,856 22,213 33,587 30,648
Other revenues 197 113 290 156
--------- --------- --------- ---------
TOTAL REVENUES 23,053 22,327 33,878 30,804
Cost of sales (13,955) (13,148) (20,507) (18,140)
--------- --------- --------- ---------
GROSS PROFIT 9,099 9,179 13,371 12,664
Research & development
expenses (4,255) (3,194) (6,254) (4,407)
S, G & A expenses (9,546) (9,850) (14,029) (13,590)
Non recurring operating
expenses (224) (309)
--------- --------- --------- ---------
Total operating expenses (13,802) (13,268) (20,282) (18,306)
OPERATING PROFIT (LOSS) (4,703) (4,089) (6,911) (5,642)
Interest (expense) income,
net 5,232 (1,243) 7,689 (1,716)
Currency exchange gains
(loss), net 577 (254) 848 (350)
Other income (loss), net (1) 16 (2) 21
--------- --------- --------- ---------
INCOME (LOSS) BEFORE TAXES
AND MINORITY INTEREST 1,105 (5,571) 1,624 (7,686)
Income tax (expense) credit 492 140 724 193
--------- --------- --------- ---------
NET INCOME (LOSS) 1,597 (5,430) 2,347 (7,492)
========= ========= ========= =========
Earning per share - Basic 0.17 (0.59) 0.24 (0.81)
Average number of shares
used in computation
of EPS 9,582,593 9,200,757 9,582,593 9,200,757
Earning per share -
Diluted 0.17 (0.59) 0.24 (0.81)
Average number of shares
used in computation of EPS
for positive net income 9,658,295 9,717,487 9,658,295 9,717,487
NOTE: Translated for convenience of the reader to U.S. dollars at the
2008 average twelve months noon buying rate of 1 Euro = 1.4695USD, and
2007 average twelve months noon buying rate of 1 Euro = 1.3797 USD.
EDAP TMS S.A.
CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (UNAUDITED)
(Amounts in thousands of Euros and U.S. Dollars)
Dec. 31, Sept. 30, Dec. 31, Sept. 30,
2008 2008 2008 2008
Euros Euros $US $US
Cash, cash equivalents and
short term investments 14,970 14,072 20,837 19,815
Total current assets 35,786 32,094 49,158 44,534
Total current liabilities 14,457 12,321 20,123 17,349
Shareholders' Equity 17,191 13,106 23,929 18,454
NOTE: Translated for convenience of the reader to U.S. dollars at the
noon buying rate of 1 Euro = 1.3919 USD, on December 31, 2008 and at
the noon buying rate of 1 Euro = 1.4081 USD, on September 30, 2008.
EDAP TMS S.A.
CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
TWELVE MONTHS ENDED DECEMBER 31, 2008
(Amounts in thousands of Euros)
Total
After
HIFU UDS FDA Consoli-
Division Division Trials Corporate dation
Sales of goods 3,658 8,888 12,547
Sales of RPPs &
Leases 3,698 966 4,664
Sales of spare
parts &
services 1,705 3,941 5,645
-------- -------- -------- -------- --------
TOTAL NET SALES 9,060 13,796 22,856
-------- -------- -------- -------- --------
Other revenues 138 59 197
-------- -------- -------- -------- --------
TOTAL REVENUES 9,199 13,855 23,053
-------- -------- -------- -------- --------
GROSS PROFIT 5,405 60% 3,694 27% 9,099 40%
Research &
Development (1,083) (1,115) (2,058) (4,255)
Total SG&A
plus
depreciation (3,848) (3,565) (97) (2,036) (9,546)
-------- -------- -------- -------- --------
OPERATING
PROFIT (LOSS) 475 (986) (2,156) (2,036) (4,703)
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