Amendment No. 1
Name of each exchange | |
Title of each class | on which registered |
None | None |
EXPLANATORY NOTE RELATING TO THIS FORM 20-F/A
We are filing this amended annual report on Form 20-F/A to modify our 2005 annual report on Form 20-F to reflect a "plain English" style and to correct certain typographical errors. These changes have been made to enable us to incorporate this report by reference into our registration statement on Form F-3 that we have filed with the Securities and Exchange Commission on the date hereof. For the convenience of the reader, this Amendment includes the complete text of all Items of the Form 20-F, as amended. However, other than the amendments described above, no changes have been made to our annual report on Form 20-F filed on June 6, 2006. This Amendment does not purport to amend or update the information contained in our annual report on Form 20-F filed on June 6, 2006 or reflect any events that have occurred after such report was filed.
Page | ||
Presentation of Financial and Other Information | 5 | |
Forward-looking Information | 5 | |
PART I | ||
Item 1. Identity of Directors, Senior Management and Advisors | 6 | |
Item 2. Offer Statistics and Expected Timetable | 6 | |
Item 3. Key Information | 2 | |
Item 4. Information on the Company | 13 | |
Item 4A. Unresolved Staff Comments | 24 | |
Item 5. Operating and Financial Review and Prospects | 24 | |
Item 6. Directors, Senior Management and Employees | 36 | |
Item 7. Major Shareholders and Related Party Transactions | 42 | |
Item 8. Financial Information | 43 | |
Item 9. The Offer and Listing | 44 | |
Item 10. Additional Information | 45 | |
Item 11. Quantitative and Qualitative Disclosures about Market Risk | 57 | |
Item 12. Description of Securities Other than Equity Securities | 58 | |
PART II | ||
Item 13. Defaults, Dividend Arrearages and Delinquencies | 59 | |
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds | 59 | |
Item 15. Controls and Procedures | 59 | |
Item 16A. Audit Committee Financial Expert | 59 | |
Item 16B. Code of Ethics | 59 | |
Item 16C. Principal Accounting Fees and Services | 59 | |
Item 16D. Exemptions from the Listing Standards for Audit Committees | 60 | |
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers | 60 | |
PART III | ||
Item 17. Financial Statements | 61 | |
Item 18. Financial Statements | 61 | |
Item 19. Exhibits | 61 |
- | the effects of intense competition in markets in which we operate; |
- | the uncertainty of market acceptance for the our HIFU devices; |
- | the uncertainty of reimbursement status of procedures performed with our products; |
- | the clinical status of the our HIFU devices; |
- | the impact of government regulation, particularly relating to public healthcare systems and the commercial distribution of medical devices; |
- | dependence on our strategic partners; |
- | reliance on patents, licenses and key proprietary technologies; |
- | product liability risk; |
- | risk of exchange rate fluctuations, particularly between the euro and the U.S. dollar and between the euro and the Japanese yen; and |
- | fluctuations in results of operations due to the cyclical nature of demand for medical devices. |
Year Ended and at December 31, | ||||||||||||||||
In thousands of euro, except per share data | 2001 | 2002 | 2003 | 2004 | 2005 | |||||||||||
INCOME STATEMENT DATA | ||||||||||||||||
Total revenues | 23,965 | 19,961 | 18,473 | 22,163 | 20,810 | |||||||||||
Total net sales | 23,804 | 19,725 | 18,030 | 21,955 | 20,717 | |||||||||||
Gross profit | 7,979 | 8,458 | 5,379 | 8,487 | 8,497 | |||||||||||
Operating expenses | (13,093 | ) | (13,234 | ) | (13,500 | ) | (9,317 | ) | (9,820 | ) | ||||||
Loss from operations | (5,114 | ) | (4,776 | ) | (8,121 | ) | (830 | ) | (1,323 | ) | ||||||
Income (loss) before income taxes | 8,019 | (3,873 | ) | (9,090 | ) | (871 | ) | (961 | ) | |||||||
Income tax (expense) benefit | (882 | ) | (167 | ) | 114 | (278 | ) | (104 | ) | |||||||
Net income (loss) | 7,137 | (4,040 | ) | (8,976 | ) | (1,149 | ) | (1,065 | ) | |||||||
Basic earnings (loss) per share | 0.92 | (0.52 | ) | (1.15 | ) | (0.15 | ) | (0.14 | ) | |||||||
Dividends per share(1) | — | — | — | — | — | |||||||||||
Weighted average shares | ||||||||||||||||
outstanding used in basic calculation | 7,760,044 | 7,771,467 | 7,781,731 | 7,781,731 | 7,782,731 | |||||||||||
Weighted average shares | ||||||||||||||||
outstanding used in diluted calculation | 7,941,869 | 7,833,514 | 7,817,303 | 8,074,210 | 8,373,574 | |||||||||||
Diluted earnings (loss) per Share | 0.90 | (0.52 | ) | (1.15 | ) | (0.15 | ) | (0.14 | ) | |||||||
BALANCE SHEET DATA | ||||||||||||||||
Total current assets | 45,927 | 34,091 | 25,870 | 22,041 | 22,777 | |||||||||||
Property and equipment, net | 2,233 | 1,985 | 2,903 | 2,807 | 3,130 | |||||||||||
Total current liabilities | 11,916 | 9,880 | 11,074 | 8,272 | 9,874 | |||||||||||
Total assets | 53,115 | 39,787 | 31,910 | 27,901 | 28,796 | |||||||||||
Long-term debt, less current portion | 304 | 95 | 7 | - | 55 | |||||||||||
Total shareholders’ equity | 38,909 | 28,375 | 18,961 | 17,964 | 17,372 |
(1) | No dividends were paid with respect to fiscal years 2001 through 2004 and subject to approval of the annual shareholders’ meeting to be held in June 2006, the Company does not anticipate paying any dividend with respect to fiscal year 2005. See Item 8, ‘‘Financial Information — Dividends and Dividend Policy.’’ |
Year ended December 31, | High | Low | Average(1) | End of Year | ||
€ | € | € | € | |||
2001 | 1.19 | 1.05 | 1.12 | 1.12 | ||
2002 | 1.16 | 0.95 | 1.05 | 0.95 | ||
2003 | 1.12 | 0.79 | 0.88 | 0.79 | ||
2004 | 0.85 | 0.73 | 0.80 | 0.74 | ||
2005 | 0.86 | 0.74 | 0.81 | 0.84 |
(1) | The average of the Noon Buying Rates on the last business day of each month during the year indicated. See ‘‘Presentation of Financial and Other Information’’ elsewhere in this annual report. |
High | Low | Average | ||||
€ | € | € | ||||
2005 | ||||||
November | 0.86 | 0.83 | 0.85 | |||
December | 0.85 | 0.83 | 0.84 | |||
2006 | ||||||
January | 0.83 | 0.81 | 0.82 | |||
February | 0.84 | 0.83 | 0.84 | |||
March | 0.84 | 0.82 | 0.83 | |||
April | 0.83 | 0.79 | 0.81 |
Our HIFU devices represent new therapies for the conditions that they are designed to treat. Notwithstanding any positive clinical results that our HIFU devices may have achieved or may achieve in the future in terms of safety and effectiveness, and any marketing approvals that we may have obtained or may obtain in the future, there can be no assurance that such products will gain acceptance in the medical community. Physician acceptance depends, among other things, on adequate reimbursement from
If the use of any of our products results in personal injury or death, we may fail significant product liability claims. To date, we are a party to two product liability actions in the United States by patients claiming to have been injured in the course of a Prostatron procedure, for which we have retained liability following the sale of our Prostatron business in October 2000. See Item 5, ‘‘Operating and Financial Review and Prospects—Critical Accounting Policies—Litigation’’ and Item 8, ‘‘Financial Information—Legal Proceedings’’ for more information about these actions. These product liability claims, if successful, could have a material adverse effect on our business, financial condition and results of operations.
In July 2002, we reorganized our management structure and created two separate operating divisions, the HIFU division and the UDS division. The implementation of the new corporate structure consolidated our management structure from a two-tiered management system with a Supervisory Board and a Management Board into a single Board of Directors with the consolidated management responsibilities of the two-tiered system.
On February 25, 2004, we finalized a distribution agreement with HealthTronics based on the terms outlined in a letter of intent. On January 28, 2005, conforming the distribution agreement and as per the approval of the January 29, 2004 extraordinary shareholders’ meeting, 1,000,000 warrants were allocated to HealthTronics. These warrants can be exercised upon the completion of certain milestones linked to the grant of the Ablatherm PMA pre-market approval and certain minimum sales of lithotripters in the United States.
Name of the Company | Jurisdiction of Establishment | Percentage Owned(1) | |
Technomed Medical Systems S.A | France | 100% | |
EDAP S.A | France | 100% | |
EDAP Technomed Inc.(2) | United States | 100% | |
EDAP Technomed Co. Ltd | Japan | 100% | |
EDAP Technomed Sdn Bhd | Malaysia | 100% | |
EDAP Technomed Srl | Italy | 100% |
(1) | Percentage of equity capital owned by EDAP TMS S.A. directly or indirectly through subsidiaries. |
(2) | EDAP Technomed Inc is still registered in the Delaware and maintained as a dormant company. |
High Intensity Focused Ultrasound (‘‘HIFU’’) Division
The HIFU division currently develops and markets devices for the minimally invasive destruction of certain types of localized tumors using HIFU technology. HIFU technology uses a high-intensity convergent ultrasound beam generated by high power transducers to produce heat. HIFU technology is intended to allow the surgeon to destroy a well-defined area of diseased tissue without damaging surrounding tissue and organs, thereby eliminating the need for incisions, transfusions and general anesthesia and associated complications. The Ablatherm is a HIFU-based device developed and marketed by the HIFU division for the treatment of organ-confined prostate cancer, referred to as T1-T2 stage. Ablatherm can be used for patients who are not candidates for surgery or who have failed a radiotherapy treatment. Ablatherm is approved for commercial distribution in the European Union, Canada, South Korea and Russia, and clinical trials in t he United States have started, with the assistance of our U.S. partner, HealthTronics. The HIFU division had a fixed installed base of 49 Ablatherm machines worldwide and 106 clinical sites were using this technology as of March 31, 2006.
In addition to developing and marketing HIFU devices, the HIFU division also generates revenues from the leasing equipment, as well as from the sale of disposables, spare parts and maintenance services. We are developing a HIFU mobile treatment option which provides access to the HIFU devices without requiring hospitals and clinics to make an up-front investment in the equipment. Instead, hospitals and clinics perform treatments using these devices and remunerate us on a revenue-per-procedure (‘‘RPP’’) basis (i.e., on the basis of the number of individual treatments provided). With this model, once the treatment is established in the medical community, a permanent installation may become more attractive, leading to the sale of the device in some of the larger locations.
· | Provide Minimally Invasive Solutions to Treat Prostate Cancer using HIFU. Building upon our established position in the ESWL market of the UDS division, our HIFU division is striving to become the leading provider of our minimally invasive treatment option for prostate cancer. We believe that there is a large market opportunity with an increase in incidence linked to the aging male population, an increase in screening and recent campaigns to increase awareness. We also believe that HIFU could represent a credible alternative to surgery, external beam radiotherapy, brachytherapy and cryotherapy for the treatment of organ-confined prostate cancer without the cost, in-patient hospitalization and adverse side effects associated with those therapies. The HIFU division intends to achieve this through a direct sales network in key European countries and through selected distributors in other European countries, through the distribution platform of the UDS division in Asia, and in partnership with HealthTronics in the United States. The HIFU division has built a strong clinical credibility based on clinical articles published in peer-reviewed journals. We ensure effective patient and physician education through a focused communication program. |
· | Achieve Long-Term Growth by Expanding HIFU Applications Beyond Prostate Cancer. The HIFU division’s long-term growth strategy is to apply our HIFU technology toward the minimally invasive treatment of indications beyond prostate cancer. We believe that HIFU could represent an alternative to surgery and radiotherapy for the treatment of many tumors without the cost, in-patient hospitalization and adverse side effects associated with those therapies. The HIFU division is working on various other applications where HIFU could provide an alternative to current invasive therapies. See ‘‘—HIFU Products.’’ The HIFU division increased spending on research and development (‘‘R&D’’) projects in 2005 to develop HIFU applications beyond prostate cancer. The division i s considering increasing R&D spending in 2006 and future years to strengthen its technological leadership in HIFU and expand its application beyond urology. |
· | Capitalize on the Current ESWL Installed Base. The UDS division’s long-term growth strategy relies on its ability to capitalize on its extensive installed base of ESWL lithotripters to recognize ongoing revenue from sales of disposables, accessories, services and replacement machines. We believe that a combination of continued investment in lowering end-user costs and offering units that are easily adaptable to various treatment environments, and a commitment to quality and service will allow the UDS division to achieve this goal. See ‘‘—UDS Division Products.’’ |
· | Capitalize on an Established Distribution Platform in Urology by Expanding Distribution Possibilities. We believe that we can achieve additional long-term growth by offering our established distribution platform in urology to other developers of medical technologies and acting as a distributor for their devices. The UDS division’s distribution platform in urology consists of a series of well-established subsidiaries in Europe and Asia as well as a network of third-party distributors worldwide. |
· | Provide Manufacturing Solutions to Other Developers of Medical Technologies. Building upon its established position in the high-tech medical devices market, we believe that the UDS division can become a provider of manufacturing alternatives to other developers of medical technologies that do not have or do not wish to invest in their own manufacturing facilities. We believe that its FDA-inspected and ISO 9001 (V:2000) and ISO 13485 (V:2003) certified facilities allow it to offer manufacturing services to a wide range of potential medical equipment developers. |
Product | Procedure | Development Stage | Clinical and Regulatory Status |
Sonolith | Electroconductive | Commercial | Approved for distribution: |
Praktis | treatment of | Production | European Union |
compact lithotripter | urinary stones | Japan | |
United States | |||
Canada | |||
Russia | |||
South Korea | |||
Australia | |||
New Zealand | |||
Sonolith Vision | Electroconductive | Commercial | Approved for distribution: |
treatment of | Production | European Union | |
urinary stones | Japan | ||
Canada | |||
South Korea | |||
Australia | |||
New Zealand |
We derive a significant portion of both net sales of medical devices and net sales of spare parts, supplies and services from our operations in Asia, through our wholly owned subsidiaries or representative offices in Japan (Edap Technomed Co. Ltd), Malaysia (Edap Technomed Sdh Bhd) and Korea (Edap Technomed Korea). Revenue derived from our operations in Asia represented approximately 33% of our total revenue in 2005. Net sales of medical devices in Asia represented approximately 31% of such sales in 2005 and consisted primarily of sales of ESWL lithotripters. Net sales of spare parts, supplies and services in Asia represented approximately 34% of such sales in 2005 and related primarily to ESWL lithotripters, reflecting the fact that approximately 44% of the installed base of our ESWL lithotripters are located in Asia.
We sell our products in many parts of the world and, as a result, our business is affected by fluctuations in currency exchange rates. We are exposed to foreign currency exchange rate risk because the mix of currencies in which our costs are denominated is different from the mix of currencies in which we earn revenues. In 2005, approximately 76% of our selling, marketing and general and administrative expenses and approximately 93% of our research and development expenses were denominated in euro, while approximately 42% of our sales were denominated in currencies other than euro (primarily the U.S. dollar and the Japanese yen). Our operating profitability could be materially affected by large fluctuations in the rate of exchange between the euro and such other currencies. To minimize our exposure to exchange rate risks, we use certain financial instruments for hedging purposes.
In accordance with Statement of Financial Accounting Standards No. 142 (SFAS No. 142), ‘‘Goodwill and Other Intangible Assets’’, we no longer amortize our goodwill on a straight-line basis over its estimated useful life but, instead, tests it for impairment on an annual basis and/or whenever indicators of impairment arise. We did not record any charge in 2005, 2004 or 2003 for the impairment of goodwill. See Note 7 of the Notes to the Consolidated Financial Statements.
On February 25, 2004, we entered into a distribution agreement with HealthTronics granting it, among other things, (i) the right to begin clinical trials in the U.S. with the Ablatherm, (ii) the right to seek PMA for the Ablatherm from the FDA and (iii) exclusive Ablatherm distribution rights in the United States, when and if a PMA is granted. Under the terms of the distribution agreement, we also granted HealthTronics 1 million warrants on January 28, 2005, each entitling HealthTronics to purchase a share of our Company at a price of U.S.$1.50 upon their vesting. The distribution agreement allows HealthTronics to exercise specified numbers of warrants as it meets various specified milestones set out in the distribution agreement, some of which relate to HealthTronics’s commitment to purchase a specified number of lithotripter units and others which relate to the completion of various stages of the clinical trials and the regulatory process leading to the PMA for the Ablatherm. On December 29, 2005, the Parties agreed to amend the distribution agreement. HealthTronics wishes to focus its efforts on obtaining the PMA for Ablatherm and on developing the HIFU market potential on the US territory, and does not want to pursue the distribution of our lithotripters in the US. Therefore, the Parties decided to amend the terms and conditions of some warrants and 200,000 warrants directly linked to the purchase of lithotripters for the years to come were then cancelled. In accordance with EITF 96-18, we account for the warrants issued to HealthTronics under the distribution agreement based on their fair value, measured at the date that the warrants vest (which corresponds to the date that a milestone in the distribution agreement is achieved). The related amou nt, which is a non-cash charge, is then recorded either as an operating expense for warrants that vest when HealthTronics achieves a milestone in the FDA approval process for the Ablatherm, or as a reduction of revenue if the warrants vest as a result of HealthTronics’s purchase of a specified number of devices. The non-cash charge recorded for 2004 as a reduction of revenue related to a series of warrants linked to HealthTronics's purchase of four lithotripters in 2004, in accordance with the terms of the agreement. The non-cash charge recorded for 2005 as a reduction of revenue related to the vesting of a series of warrants linked to HealthTronics's purchase of two lithotripters and one Ablatherm in 2005, in accordance with the terms of the Amendment to the distribution agreement dated December 29, 2005.
- | a net loss of €1.1 million, |
- | elimination of €1.8 million of net expenses without effects on cash, |
- | an increase in trade accounts receivable of €1.5 million, principally reflecting an increase in revenue in the fourth quarter of 2005, |
- | an increase in inventories of €0.7 million related to an increase in both the inventory of finished goods and spare parts, primarily due to an increase in spare parts inventory, itself reflecting anticipated revenue growth greater than actual growth, |
- | an increase in trade accounts payable of €0.7 million, also primarily due to the increase in activity in the fourth quarter of 2005 and, |
- | an increase in accrued expenses and other current liabilities of €0.4 million. |
Payments Due by Period | ||||||
Total | Less than 1 year | 1-3 years | 4-5 years | More than 5 years | ||
Short-Term Debt | 899 | 899 | — | — | — | |
Long-Term Debt | 202 | 147 | 55 | — | — | |
Capital Lease Obligations | 859 | 385 | 474 | — | — | |
Operating Leases | 481 | 428 | 53 | — | — |
1. | A “modified prospective” method, in which compensation cost is recognized beginning with the effective date (a) based on the requirements of Statement 123(R) for all share-based payments granted after the effective date and (b) based on the requirements of Statement 123 for all awards granted to employees before the effective date of Statement 123(R) that remain unvested on the effective date. |
2. | A “modified retrospective” method, which includes the requirements of the modified prospective method described above, but also permits entities to restate based on the amounts previously recognized under Statement 123 for purposes of pro forma disclosures either (a) all prior periods presented or (b) prior interim periods of the year of adoption. |
Name | Age | Position |
Philippe Chauveau | 70 | Chairman of the Board of Directors |
Hugues de Bantel | 36 | Chief Executive Officer of EDAP TMS S.A. and President of the HIFU Division and the UDS Division |
Thierry Turbant | 45 | Chief Financial Officer |
Philippe Chauveau | In 1997, Philippe Chauveau was named chairman of EDAP-TMS S.A.'s Supervisory Board, involving a two-tier board structure overseeing a Management Board. In 2002, both these boards were replaced by a single Board of Directors, which Philippe Chauveau headed as Chairman and CEO. While remaining Chairman of the Board, he was succeeded by Hugues de Bantel as CEO in 2004. Since 2002, Philippe Chauveau has also served as founding Chairman of the Board of Scynexis Inc., funded by private equity, which is an innovative drug discovery company based in the United States, partnering with major pharmaceutical companies worldwide. As of today, he remains on the Board as a Director. He is also personal executive coach to senior research leaders at Hoffmann LaRoche. Additionally, he is involved in management development programs at IMD, in Lausanne, Switzerland. He was R&D Vice-President at AT&T Bell Labs and has also served as Chairman of Apple Computer Europe, preceded by increasing marketing roles in ITT and in Procter & Gamble. He has an Honours Degree from Trinity College Dublin with a BA. and a Bsc. | |
Hugues de Bantel | Hugues de Bantel joined the Company in 1996, and since then has served as Asia Pacific Area Manager and Manager of EDAP Technomed Malaysia from its founding in 1997 and, since April 2000, President of EDAP Technomed Japan. He was appointed President of TMS S.A. on November 6, 2002, and President of EDAP S.A. on November 13, 2003. Before joining EDAP Technomed, Mr. de Bantel was Sales Manager for Europe and Asia at AFE’s Lifts Division. He previously worked at Procter & Gamble as Area Sales Manager. Mr. de Bantel graduated from Ecole Superieure de Commerce, Rouen (France). | |
Thierry Turbant | Thierry Turbant was appointed Chief Financial Officer of the Company on July 1, 2004. He joined the Company in 1997, and since then has served as Group Financial Controller. Before joining the Company, Mr. Turbant was Accounting Manager and Controller at Gatefossé, specialized in Pharmaceutical and Cosmetic Products. He previously worked at EGL and at Clemessy (Civil Engineering) as a Controller. Mr. Turbant graduated from the Business and Management Institute (IAE) at Lyon University (France). |
Philippe Chauveau | See biography under “—Senior Executive Officers.” |
Pierre Beysson Age: 64 | Pierre Beysson was appointed as a member of the Board of Directors in September 2002. Pierre Beysson was then the Chief Financial Officer of Compagnie des Wagons-Lits ("CWL"), the on-board train service division of Accor, a French multinational Hotel and Business Services Group. In this capacity, he sat on a number of boards of companies related to the Accor Group. He is now an M&A consultant. Before his assignment at CWL, Pierre Beysson held a number of senior financial positions with Nixdorf Computers, Trane (Air Conditioning), AM International (Office Equipment) and FMC (Petroleum Equipment). Pierre Beysson was trained as a CPA, has auditing experience and holds an MBA from Harvard Business School. |
Karim Fizazi Age: 40 | Dr. Karim Fizazi was appointed as a member of the Company's Board of Directors in November 2002. He is currently Chairman of the Genito-Urinary Oncology group at Institut Gustave Roussy (“IGR”) in Villejuif, France, which is the biggest cancer center in Europe. He was appointed Head of Department of Medicine of Institut Gustave Roussy in 2005. He is also Assistant Professor in Medical Oncology at IGR. He was visiting Assistant Professor, Genitourinary Medical Oncology Department, MD Anderson Cancer Center in Houston, Texas, for 18 months. His residency included a position at the Institut Curie in Paris. |
Olivier Missoffe Age: 49 | Olivier Missoffe was appointed as a member of the Company's Board of Directors in November 2002. He is Chairman and CEO of Société Services de Santé (SSS), a services and support provider to hospitals and clinics. He is an advisor to the Management Board of the French healthcare group "Générale de Santé." He was Chief Executive Officer of the Company until 1998. |
Siemens France S.A., represented by Holger Schmidt Age: 40 | Siemens France S.A. was appointed as a member of the Company's Supervisory Board in January 1997 following Siemens purchase of 1,003,250 shares of the Company, representing 12.0% of the Company's total share capital. Siemens became a member of the Company's Board of Directors in July 2002. |
Guy Vallancien Age: 59 | Dr. Guy Vallancien was appointed as a member of the Company's Board of Directors in November 2002. He is Professor of Urology and Chief of the Urology Department at the Institut Mutualiste Montsouris (Paris, France). He is a member of the Executive Committee of the French Urological Association (AFU) and a member of the European and International Urological Association. |
- | Provide assistance to the Board of Directors in fulfilling their oversight responsibility to the shareholders, potential shareholders, the investment community and others relating to: the integrity of the Company’s financial statements, the Company’s compliance with legal and regulatory requirements, the accounting practices and financial reporting processes of the Company, the effectiveness of the Company’s disclosure controls and procedures and internal control over financial reporting, the independent auditor’s qualifications and independence, and the performance of the Company’s internal audit function and independent auditors. |
- | Prepare the Audit Committee report that SEC proxy rules require to be included in our annual proxy statement. The Audit Committee may request any officer or employee of the Company or the Company’s outside counsel or independent auditor to attend a meeting of the Committee or to meet with any members of, or consultants to, the Committee. |
Sales & Marketing | Manufac- turing | Service | Research & Dvpt | Regula- tory | Clinical Affairs | Adminis- trative | Total | |
France | 14 | 26 | 25 | 14 | 5 | 4 | 14 | 102 |
Italy | 3 | 0 | 0 | 0 | 0 | 0 | 3 | 6 |
Japan | 11 | 0 | 13 | 0 | 1 | 0 | 5 | 30 |
Malaysia | 2 | 0 | 3 | 0 | 0 | 0 | 2 | 7 |
USA | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
South Korea | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
Total = | 31 | 26 | 41 | 14 | 6 | 4 | 26 | 148 |
Sales & Marketing | Manufac- turing | Service | Research & Dvpt | Regula- tory | Clinical Affairs | Adminis- trative | Total | |
France | 11 | 21 | 22 | 8 | 3 | 1 | 14 | 80 |
Italy | 3 | 0 | 0 | 0 | 0 | 0 | 2 | 5 |
Japan | 9 | 0 | 13 | 0 | 2 | 0 | 4 | 28 |
Malaysia | 2 | 0 | 3 | 0 | 0 | 0 | 2 | 7 |
South Korea | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
Total = | 26 | 21 | 38 | 8 | 5 | 1 | 23 | 122 |
Sales & Marketing | Manufac- turing | Service | Research & Dvpt | Regula- tory | Clinical Affairs | Adminis- trative | Total | |
France | 13 | 22 | 24 | 8 | 3 | 2 | 15 | 87 |
Italy | 3 | 0 | 0 | 0 | 0 | 0 | 3 | 6 |
Germany | 2 | 0 | 2 | 0 | 0 | 0 | 2 | 4 |
Japan | 9 | 0 | 13 | 0 | 2 | 0 | 4 | 28 |
Malaysia | 2 | 0 | 3 | 0 | 0 | 0 | 2 | 7 |
South Korea | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
Total = | 30 | 22 | 40 | 8 | 5 | 2 | 27 | 134 |
months until expiration | Number of Shares |
24 | 33,625 |
36 | 92,000 |
48 | 1,212 |
72 | 112,000 |
78 | 14,425 |
98 | 325,000 |
109 | 15,000 |
2005 | 2004 | 2003 | ||||
Options | Weighted average exercise price (€) | Options | Weighted average exercise price (€) | Options | Weighted average exercise price (€) | |
Outstanding on January 1, | 580,262 | 2.49 | 391,262 | 2.68 | 654,341 | 2.58 |
Granted | 15,000 | 2.78 | 325,000 | 2.19 | 0 | |
Exercised | (1,000) | 1.62 | 0 | 0 | ||
Forfeited | (1,000) | 3.81 | (136,000) | 2.34 | (263,079) | 2.43 |
Expired | - | - | - | - | - | - |
Outstanding on December 31, | 593,262 | 2.50 | 580,262 | 2.49 | 391,262 | 2.68 |
Exercisable on December 31, | 409,652 | 2.45 | 219,547 | 2.99 | 272,442 | 2.94 |
Shares purchase options available for grant on December 31 | 0 | - | 0 | - | 0 | - |
Outstanding options | Exercisable options | |||||
Exercise price (€) | Options | Weighted average remaining contractual life | Weighted average exercise price (€) | Options | Weighted average exercise price (€) | |
3.81 | 116,625 | 2.5 | 3.81 | 116,625 | 3.81 | |
2.78 | 15,000 | 9.1 | 2.78 | 3,750 | 2.78 | |
2.60 | 240,000 | 8.7 | 2.60 | 60,000 | 2.60 | |
2.08(1) | 112,000 | 6.0 | 2.08 | 112,000 | 2.08 | |
2.02(2) | 14,425 | 6.5 | 2.02 | 10,815 | 2.02 | |
1.83 | 10,212 | 3.5 | 1.83 | 10,212 | 1.83 | |
1.28 | 100,000 | 8.2 | 1.28 | 100,000 | 1.28 | |
1.28 to 3.81 | 593,262 | 6.3 | 2.50 | 409,652 | 2.11 |
(1) | All the 112,000 options were granted on September 25, 2001 with an exercise price expressed in U.S. dollars ($1.92) and converted here to euros based on the noon buying rate on September 25, 2001 ($1 = € 1.085). |
(2) | All the 14,425 options were granted on June 18, 2002 with an exercise price expressed in U.S. dollars ($1.92) and converted here to euros based on the noon buying rate on June 18, 2002 ($1 = € 1.0545). |
Nasdaq | ||||||
High | Low | |||||
$ | ||||||
2006 (through March 31) | 21.64 | 5.30 | ||||
2005 | 5.68 | 3.10 | ||||
2004 | 3.92 | 1.55 | ||||
2003 | 1.99 | 1.00 | ||||
2002 | 2.49 | 1.15 | ||||
2001 | 3.43 | 0.59 |
Nasdaq | ||||||
High | Low | |||||
$ | ||||||
2006: | ||||||
First Quarter | 21.64 | 5.30 | ||||
2005: | ||||||
First Quarter | 5.50 | 3.41 | ||||
Second Quarter | 5.00 | 3.65 | ||||
Third Quarter | 4.27 | 3.18 | ||||
Fourth Quarter | 5.68 | 3.10 | ||||
2004: | ||||||
First Quarter | 2.12 | 1.55 | ||||
Second Quarter | 3.61 | 1.95 | ||||
Third Quarter | 2.51 | 1.64 | ||||
Fourth Quarter | 3.92 | 1.96 |
Nasdaq | ||||||
High | Low | |||||
$ | ||||||
2005: | ||||||
November | 4.50 | 3.25 | ||||
December | 5.68 | 3.81 | ||||
2006: | ||||||
January | 8.65 | 5.30 | ||||
February | 8.88 | 7.25 | ||||
March | 21.64 | 8.43 | ||||
April | 19.46 | 12.68 |
- | the taking of financial interests, under whatever form, in all French or foreign groups, companies or businesses which currently exist or which may be created in the future, mainly through contribution, subscription or purchasing of stocks or shares, obligations or other securities, mergers, holding companies, groups, alliances or partnerships; |
- | the management of such financial interests; |
- | the direction, management, control and coordination of its subsidiaries and interests; |
- | the provision of all administrative, financial, technical or other services; and |
- | generally, all operations of whatever nature, financial, commercial, industrial, civil, relating to property and real estate which may be connected directly or indirectly, in whole or in part, to the Company’s purposes or to any other similar or related purposes which may favor the extension or development of said purposes. |
All shareholders who have properly registered their shares have the right to participate in general meetings, either in person, by proxy, or by mail, and to vote according to the number of shares they hold. Each share confers on the shareholder the right to one vote. Under French law, an entity controlled directly or indirectly by the Company is prohibited from holding shares in the Company and, in the event it becomes a shareholder, such entity would not be entitled to any voting rights. A proxy may be granted by a shareholder whose name is registered on the Company’s share registry to his or her spouse, to another shareholder or to a legal representative, in the case of a legal entity, or by sending a proxy in blank to the Company without nominating any representatives. In the latter case, the Chairman of the shareholders’ meeting will vote such blank proxy in favor of all resolutions proposed by the Board of Di rectors and against all others.
· | the beneficial owner of the shares or ADSs (and the dividends paid with respect thereto); |
· | an individual resident of the United States, a U.S. corporation, or a partnership, estate or trust to the extent its income is subject to taxation in the United States in its hands or in the hands of its partners or beneficiaries; |
· | not also a resident of France for French tax purposes; and |
· | not subject to an anti-treaty shopping article that applies in limited circumstances. |
To benefit from the lower rate of withholding tax applicable under the Treaty before the payment of the dividend, you must use the simplified procedure and are no longer allowed to file a Form RF 1 A EU-No. 5052 or a Form RF 1 B EU-No. 5053.
The simplified procedure entails completing and delivering to the French tax authorities a certificate stating that:
· | you are a U.S. resident within the meaning of the Treaty; |
· | the dividend is not derived from a permanent establishment or a fixed base that you own in France; |
· | the dividend received is subject to tax in the United States. |
· | 75% or more of the Company’s gross income is treated as passive income for purposes of the PFIC rules; or |
· | the average percentage of the value of the Company’s assets that produce or are held for the production of passive income is at least 50%. |
Nature of the Fees | 2004 (in €) | 2005 (in €) | ||
Audit fees | 143,265 | 136,020 | ||
Audit-related fees | 8,010 | 97,305 | ||
Tax fees | - | - | ||
All other fees | - | - | ||
Total | 151,275 | 233,325 |
1.1 | By-laws (statuts) of EDAP TMS S.A. as amended as of June 21, 2005 (together with an English translation thereof).(1) |
4.1 | (a) | Distribution Agreement, dated as of February 25, 2004, among the Company, HT Prostate Therapy Management Company, LLC, EDAP S.A. and Technomed Medical Systems, S.A.(2) |
(b) | Amendment No. 1 to the Distribution Agreement dated December 23, 2004.(1) |
(c) | Amendment No. 2 to the Distribution Agreement dated December 29, 2005.(1) |
4.2 | (a) | Commercial Leases dated October 1, 2002 and Amendment No. 1 dated October 15, 2002, between Maison Antoine Baud and EDAP TMS S.A., EDAP S.A. and Technomed Medical Systems S.A. (together with an English translation thereof). (1) |
(b) | Appendix No. 2 to commercial leases between TMS S.A. and Maison Antoine Baud, signed on June 28, 2004. (1) |
8.1 | List of subsidiaries of EDAP TMS S.A. as of March 31, 2006.(1) |
11.1 | Code of Ethics of the Company, approved by the Board of Directors on July 22, 2005.(1) |
12.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
12.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
13.1 | Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002. |
(1) | Previously filed. |
(2) | Previously filed with certain confidential portions omitted under Rule 24b-2 under the Securities Exchange Act of 1934. |
Audited Consolidated Financial Statements for EDAP TMS S.A. and Subsidiaries for the Years Ended December 31, 2005, 2004 and 2003 | |
Report of Independent Auditors | F-1 |
Consolidated Balance Sheets as of December 31, 2005 and 2004 | F-3 |
Consolidated Statements of Income for the years ended December 31, 2005, 2004 and 2003 | F-4 |
Consolidated Statements of Comprehensive Income for the years ended December 31, 2005, 2004 and 2003 | F-5 |
Consolidated Statements of Shareholders’ Equity for the years ended December 31, 2005, 2004 and 2003 | F-6 |
Consolidated Statements of Cash Flows for the years ended December 31, 2005, 2004 and 2003 | F-7 |
Notes to Consolidated Financial Statements | F-8 |
ASSETS | Notes | 2005 | 2004 |
Current assets | |||
Cash and cash equivalents | 2 | 8,317 | 9,398 |
Trade accounts and notes receivable, net of allowance of €663 in 2005 and €705 in 2004 | 3 | 8,769 | 7,722 |
Other receivables | 4 | 850 | 473 |
Inventories | 5 | 4,450 | 3,939 |
Deferred tax assets | 21-3 | 0 | 77 |
Prepaid expenses | 391 | 432 | |
Total current assets | 22,777 | 22,041 | |
Property and equipment, net | 6 | 3,130 | 2,807 |
Intangible assets, net | 7 | 86 | 119 |
Goodwill | 7 | 2,412 | 2,412 |
Deposits and other non-current assets | 391 | 522 | |
Total assets | 28,796 | 27,901 | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||
Current liabilities | |||
Trade accounts and notes payable | 8 | 4,305 | 3,675 |
Deferred revenues, current portion | 9 | 771 | 843 |
Social security and other payroll withholdings taxes | 605 | 513 | |
Employee absences compensation | 438 | 424 | |
Income taxes payable | 19 | ||
Accruals for restructuring | 18 | 136 | |
Other accrued liabilities | 10 | 2,305 | 1,816 |
Short-term borrowings | 12 | 899 | 525 |
Current portion of capital lease obligations | 11 | 385 | 334 |
Current portion of long-term debt | 13 | 147 | 6 |
Total current liabilities | 9,874 | 8, 272 | |
Deferred revenues, long term portion | 9 | 439 | 442 |
Capital lease obligations, less current portion | 11 | 474 | 663 |
Long-term debt, less current portion | 13 | 55 | — |
Deferred income taxes | 21-3 | 7 | 0 |
Other long-term liabilities | 14 | 575 | 560 |
Total liabilities | 11,424 | 9,937 | |
Shareholders’ equity | |||
Common stock, €0.13 par value, 9,318,875 shares authorized; | |||
8,362,821 shares issued; 7,782,731 and 7,781,731 shares outstanding at December 31, | |||
2005 and 2004, respectively | 1,087 | 1,087 | |
Additional paid-in capital | 20,359 | 19,999 | |
Retained earnings | 597 | 1,662 | |
Cumulative other comprehensive loss | (2,877) | (2,987) | |
Treasury stock, at cost; 580,090 and 581,090 shares at December 31, 2005 and 2004, respectively | (1,794) | (1,797) | |
Total shareholders’ equity | 15 | 17,372 | 17,964 |
Total liabilities and shareholders’ equity | 28,796 | 27,901 |
Notes | 2005 | 2004 | 2003 | |
Sales of medical devices | 10,242 | 11,922 | 8,512 | |
Sales of disposables, RPPs, leases, spare parts and services | 10,710 | 10,207 | 9,518 | |
Total sales | 16 | 20,952 | 22,129 | 18,030 |
Warrants granted | (235) | (174) | - | |
Total net sales | 16 | 20,717 | 21,955 | 18,030 |
Other revenues | 17 | 93 | 208 | 443 |
Total revenues | 20,810 | 22,163 | 18,473 | |
Cost of sales | (12,313) | (13,676) | (13,094) | |
Gross profit | 8,497 | 8,487 | 5,379 | |
Research and development expenses | (1,784) | (1,523) | (3,069) | |
Selling and marketing expenses | (3,758) | (3,402) | (4,228) | |
General and administrative expenses | (4,278) | (4,074) | (4,106) | |
Non recurring operating expenses | 18 | - | (318) | (2,097) |
Loss from operations | (1,323) | (830) | (8,121) | |
Interest income, net | 19 | 135 | 71 | 177 |
Foreign currency exchange gain (loss), net | 218 | (38) | (928) | |
Other income (expense), net | 20 | 9 | (74) | (218) |
Loss before taxes | (961) | (871) | (9,090) | |
Income tax (expense) benefit | 21 | (104) | (278) | 114 |
Net loss | (1,065) | (1,149) | (8,976) | |
Basic loss per share | 1-18 | (0.14) | (0.15) | (1.15) |
Weighted average shares outstanding used in basic | ||||
calculation | 1-18 | 7,782,731 | 7,781,731 | 7,781,731 |
Diluted loss per share | 1-18 | (0.14) | (0.15) | (1.15) |
Weighted average shares outstanding used in | ||||
diluted calculation | 1-18 | 8,373,574 | 8,074,210 | 7,817,303 |
2005 | 2004 | 2003 | |
Net loss | (1,065) | (1,149) | (8,976) |
Other comprehensive loss: | |||
Foreign currency translation adjustments | 110 | (36) | (547) |
Comprehensive loss, net of tax | (955) | (1,185) | (9,523) |
Number of Shares | Common Stock | Additional paid-in Capital | Retained Earnings | Cumulative Other Comprehensive Income (loss) | Treasury Stock | Total | |
Balance as of January 1, 2003 | 7,781,731 | 1,087 | 19,811 | 11,787 | (2,513) | (1,797) | 28,375 |
Net loss | (8,976) | (8,976) | |||||
Translation adjustment | (547) | (547) | |||||
Change in unrealized gain/loss on | |||||||
investments available for sale | 109 | 109 | |||||
Balance as of December 31, 2003 | 7,781,731 | 1,087 | 19,811 | 2,811 | (2,951) | (1,797) | 18,961 |
Net loss | (1,149) | (1,149) | |||||
Translation adjustment | (36) | (36) | |||||
Warrants and stock options granted | 188 | 188 | |||||
Balance as of December 31, 2004 | 7,781,731 | 1,087 | 19,999 | 1,662 | (2,987) | (1,797) | 17,964 |
Net loss | (1,065) | (1,065) | |||||
Translation adjustment | 110 | 110 | |||||
Warrants and stock options granted | 1,000 | 360 | 3 | 363 | |||
Balance as of December 31, 2005 | 7,782,731 | 1,087 | 20,359 | 597 | (2,877) | (1,794) | 17,372 |
2005 | 2004 | 2003 | |
Cash flows from operating activities | |||
Net loss | (1,065) | (1,149) | (8,976) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation and amortization | 1,202 | 1,049 | 983 |
Non-cash compensation (1) | 360 | 188 | — |
Change in allowances for doubtful accounts & slow-moving inventories | 128 | (834) | (147) |
Change in long-term provisions | 67 | (94) | 46 |
Deferred tax expense/(benefit) | 84 | 255 | (226) |
Net loss (gain) on sale of assets | (21) | (389) | (9) |
Net loss (gain) on sale of investments available for sale | — | — | 123 |
Increase/Decrease in operating assets and liabilities: | |||
Decrease/(Increase) in trade accounts and notes and other receivables | (1,473) | 20 | 3,076 |
Decrease/(Increase) in inventories | (681) | 2,341 | 1,110 |
Decrease/(Increase) in prepaid expenses | 41 | (9) | (36) |
(Decrease)/Increase in trade accounts and notes payable | 632 | (439) | (1,025) |
(Decrease)/Increase in accrued expenses, other current liabilities | 441 | (1,884) | 1,432 |
Net cash (used in) provided by operating activities | (285) | (945) | (3,649) |
Cash flows from investing activities | |||
Acquisitions of property and equipment | (372) | (247) | (400) |
Acquisitions of intangible assets | (24) | (18) | (27) |
Capitalized assets produced by the Company | (1,042) | (750) | (780) |
Net proceeds from sale of assets | 113 | 722 | 10 |
Net proceeds from sale of leased back assets | 239 | 342 | 250 |
Proceeds from sale of investments available for sale | — | — | 55 |
Increase in deposits and guarantees | (21) | (108) | — |
Reimbursement of deposits and guarantees | 48 | 75 | 350 |
Net cash (used in) provided by investing activities | (1,059) | 16 | (542) |
Cash flow from financing activities | |||
Proceeds from long term borrowings | 288 | — | — |
Repayment of long term borrowings | (93) | (77) | (370) |
Repayment of obligations under capital leases | (378) | (316) | (77) |
Increase/(decrease) in bank overdrafts and short-term borrowings | 371 | 310 | (222) |
Net cash used in financing activities | 188 | (83) | (669) |
Net effect of exchange rate changes on cash and cash equivalents | 75 | (19) | (466) |
Net increase/(decrease) in cash and cash equivalents | (1,081) | (1,031) | (5,326) |
Cash and cash equivalents at beginning of year | 9,398 | 10,429 | 15,755 |
Cash and cash equivalents at end of year | 8,317 | 9,398 | 10,429 |
Leasehold improvements | 10 years or lease term if shorter |
Equipment | 3-10 years |
Furniture, fixtures, fittings and other | 2-10 years |
Patents | 5 years |
Licenses | 5 years |
Tradename and trademark | 7 years |
· | assets and liabilities are translated at year-end exchange rates; |
· | shareholders’ equity is translated at historical exchange rates (as of the date of contribution); |
· | statement of income items are translated at average exchange rates for the year; and |
· | translation gains and losses are recorded in a separate component of shareholders’ equity. |
Year Ended December 31, | |||
2005 | 2004 | 2003 | |
Net loss, as reported | (1,065) | (1,149) | (8,976) |
Add: Stock-based employee compensation expense included in | |||
Reported net loss, net of related tax effects | 125 | 14 | — |
Deduct: Total stock-based employee compensation expense | |||
Determined under fair value-based method for all awards, net | |||
of related tax effects | (231) | (44) | (56) |
Pro forma net loss | (1,171) | (1,179) | (9,032) |
Loss per share: | |||
Basic, as reported | (0.14) | (0.15) | (1.15) |
Basic, pro forma | (0.15) | (0.15) | (1.16) |
Diluted, as reported | (0.14) | (0.15) | (1.15) |
Diluted, pro forma | (0.15) | (0.15) | (1.16) |
Year Ended December 31, | ||||||
2005 | 2004 | |||||
Weighted-average expected life (years) | 2 | 3.08 | ||||
Expected volatility rates | 75% | 85% | ||||
Expected dividend yield | — | — | ||||
Risk-free interest rate | 4.3% | 3.3% | ||||
Weighted-average exercise price (€) | 2.78 | 2.19 | ||||
Weighted-average fair value of options granted during the year (€) | 1.82 | 0.51 |
1. | A “modified prospective” method, in which compensation cost is recognized beginning with the effective date (a) based on the requirements of Statement 123(R) for all share-based payments granted after the effective date and (b) based on the requirements of Statement 123 for all awards granted to employees prior to the effective date of Statement 123(R) that remain unvested on the effective date. |
2. | A “modified retrospective” method, which includes the requirements of the modified prospective method described above, but also permits entities to restate based on the amounts previously recognized under Statement 123 for purposes of pro forma disclosures either (a) all prior periods presented or (b) prior interim periods of the year of adoption. |
December 31, | |||||
2005 | 2004 | ||||
Cash held at bank | 8,317 | 5,659 | |||
Money market funds | - | 3,739 | |||
Total | 8,317 | 9,398 |
December 31, | |||||
2005 | 2004 | ||||
Trade accounts receivable | 9,281 | 8,335 | |||
Notes receivable | 151 | 92 | |||
Less: allowance for doubtful accounts | (663) | (705) | |||
Total | 8,769 | 7,722 |
December 31, | |||||
2005 | 2004 | ||||
Tax loss carryback receivable from the French State | - | 109 | |||
Value-added taxes receivable from the French State | 521 | 210 | |||
Research and development tax credit receivable from the French State | 64 | - | |||
Other receivables from the French State | 31 | 16 | |||
Others | 234 | 138 | |||
Total | 850 | 473 |
December 31, | |||||
2005 | 2004 | ||||
Components, spare parts | 3,759 | 3,491 | |||
Work-in-progress | 369 | 326 | |||
Finished goods | 1,196 | 826 | |||
Total gross inventories | 5,324 | 4,643 | |||
Less: provision for slow-moving inventory | (874) | (704) | |||
Total | 4,450 | 3,939 |
December 31, | |||||
2005 | 2004 | ||||
Equipment | 5,852 | 4,647 | |||
Furniture, fixture, and fittings and other | 2,280 | 2,180 | |||
Total gross value | 8,132 | 6,827 | |||
Less: accumulated depreciation and amortization | (5,002) | (4,020) | |||
Total | 3,130 | 2,807 |
December 31, | |||||
2005 | 2004 | ||||
Licenses | 443 | 419 | |||
Tradename and trademark | 585 | 583 | |||
Patents | 412 | 412 | |||
Organization costs | 363 | 363 | |||
Total gross value | 1,803 | 1,777 | |||
Less: accumulated amortization | (1,717) | (1,658) | |||
Total | 86 | 119 |
December 31, | |||||
2005 | 2004 | ||||
Trade accounts payable | 3,532 | 2,913 | |||
Notes payable | 773 | 762 | |||
Total | 4,305 | 3,675 |
December 31, | |||||
2005 | 2004 | ||||
Deferred revenues on maintenance contracts | 375 | 370 | |||
Deferred revenue on sale of devices | 645 | 676 | |||
Deferral of the gain on sale-lease-back Transactions | 189 | 239 | |||
Total | 1,210 | 1,285 | |||
Less long term portion | 439 | 442 | |||
Current portion | 771 | 843 |
December 31, | ||||||
2005 | 2004 | |||||
Provision for warranty costs | 700 | 660 | ||||
Value added tax payable | 543 | 273 | ||||
Accruals for social expenses | 348 | 301 | ||||
Conditional government subsidies | 398 | 318 | ||||
Advance to debtors | 29 | 28 | ||||
Others | 287 | 236 | ||||
Total | 2,305 | 1,816 |
December 31, | |||||
2005 | 2004 | ||||
Beginning of year | 660 | 694 | |||
Amount used during the year (payments) | (477) | (592) | |||
New warranty expenses | 517 | 558 | |||
End of year | 700 | 660 |
December 31, 2005 | ||||
2006 | 417 | |||
2007 | 302 | |||
2008 | 151 | |||
2009 | 61 | |||
Total minimum lease payments | 931 | |||
Less: amount representing interest | (72) | |||
Present value of minimum lease payments | 859 | |||
Less: current portion | (385) | |||
Long-term portion | 474 |
TMS | Japan | ||||
2006 | 241 | 187 | |||
2007 | - | 47 | |||
2008 | - | 6 | |||
Total | 241 | 241 |
December 31, | |||||
2005 | 2004 | ||||
Japanese yen term loan | 202 | - | |||
Other financial debts | - | 6 | |||
Total | 202 | 6 | |||
Less current portion | (147) | (6) | |||
Total long-term portion | 55 | 0 |
2006 | 147 | ||||
2007 | 55 | ||||
Total | 202 |
December 31, | |||||
2005 | 2004 | ||||
Provision for retirement indemnities | 469 | 379 | |||
Other | 106 | 181 | |||
Total | 575 | 560 |
Pension Benefits - France | |||||
2005 | 2004 | 2003 | |||
Weighted average assumptions: | |||||
Discount rate | 4.00% | 4.50% | 4.50% | ||
Salary increase | 2.00% | 2.00% | 2.50% | ||
Retirement age | 65 | 65 | 63 | ||
Average retirement remaining service period | 27 | 26 | 25 |
Pension Benefits - Japan | |||||
2005 | 2004 | 2003 | |||
Weighted average assumptions: | |||||
Discount rate | 1.50% | 1.50% | 1.50% | ||
Salary increase | 1.80% | 1.80% | 1.80% |
France | Japan | ||
Projected benefit obligation | 229 | 262 | |
Normal cost | 23 | 36 | |
Accumulated benefit obligation | 163 | 225 | |
Accrued pension cost | 202 | 132 |
France | 2005 | 2004 |
Change in benefit obligations | ||
Benefit obligations at beginning of year | 132 | 155 |
Service cost | 17 | 19 |
Interest cost | 6 | 7 |
Plan amendments | - | - |
(gain) / loss | 74 | (49) |
Benefits paids | - | - |
Benefit obligations at end of year | 229 | 132 |
Change in plan assets | ||
Fair value of plan assets at beginning of year | - | - |
Employer contribution | - | - |
Return on plan assets | - | - |
Benefits paid | - | - |
Fair value of plan assets at end of year | ||
Unrecognized actuarial (gain) loss | 27 | (49) |
Unrecognized prior service cost | - | - |
Accrued pension cost | 202 | 181 |
JAPAN | 2005 | 2004 |
Change in benefit obligations | ||
Benefit obligations at beginning of year | 217 | 140 |
Service cost | 35 | - |
Interest cost | 3 | - |
Plan amendments | - | - |
Termination benefits | - | 25 |
(gain) / loss | 7 | 136 |
Benefits paids | - | (84) |
Benefit obligations at end of year | 262 | 217 |
Change in plan assets | ||
Fair value of plan assets at beginning of year | - | - |
Employer contribution | - | - |
Return on plan assets | - | - |
Benefits paid | - | - |
Fair value of plan assets at end of year | ||
Unrecognized actuarial (gain) loss | 130 | 136 |
Unrecognized prior service cost | 0 | 0 |
Accrued pension cost | 132 | 81 |
2005 | 2004 | 2003 | ||||
Options | Weighted average exercise price (€) | Options | Weighted average exercise price (€) | Options | Weighted average exercise price (€) | |
Outstanding on January 1, | 580,262 | 2.49 | 391,262 | 2.68 | 654,341 | 2.58 |
Granted | 15,000 | 2.78 | 325,000 | 2.19 | 0 | |
Exercised | (1,000) | 1.62 | 0 | 0 | ||
Forfeited | (1,000) | 3.81 | (136,000) | 2.34 | (263,079) | 2.43 |
Expired | - | - | - | - | - | - |
Outstanding on December 31, | 593,262 | 2.50 | 580,262 | 2.49 | 391,262 | 2.68 |
Exercisable on December 31, | 409,652 | 2.45 | 219,547 | 2.99 | 272,442 | 2.94 |
Shares purchase options available for grant on December 31 | 0 | - | 0 | - | 0 | - |
Outstanding options | Exercisable options | |||||
Exercise price (€) | Options | Weighted average remaining contractual life | Weighted average exercise price (€) | Options | Weighted average exercise price (€) | |
3.81 | 116,625 | 2.5 | 3.81 | 116,625 | 3.81 | |
2.78 | 15,000 | 9.1 | 2.78 | 3,750 | 2.78 | |
2.60 | 225,000 | 8.2 | 2.60 | 56,250 | 2.60 | |
2.08(1) | 112,000 | 6.0 | 2.08 | 112,000 | 2.08 | |
2.02(2) | 14,425 | 6.5 | 2.02 | 10,815 | 2.02 | |
1.83 | 10,212 | 3.5 | 1.83 | 10,212 | 1.83 | |
1.28 | 100,000 | 8.2 | 1.28 | 100,000 | 1.28 | |
1.28 to 3.81 | 593,262 | 6.3 | 2.50 | 409,652 | 2.11 |
(1) | All the 112,000 options were granted on September 25, 2001 with an exercise price expressed in U.S. dollars ($1.92) and converted here to euros based on the noon buying rate on September 25, 2001 ($1 = € 1.085). |
(2) | All the 14,425 options were granted on June 18, 2002 with an exercise price expressed in U.S. dollars ($1.92) and converted here to euros based on the noon buying rate on June 18, 2002 ($1 = € 1.0545). |
2005 | 2004 | 2003 | |
Medical devices | 10,242 | 11,922 | 8,557 |
Disposables | 1,956 | 1,901 | 1,850 |
RPPs | 1,747 | 1,422 | 562 |
Leases | 1,399 | 1,564 | 1,462 |
Spare parts & services | 5,608 | 5,320 | 5,599 |
Total sales | 20,952 | 22,129 | 18,030 |
Warrants granted | (235) | (174) | |
Total net sales | 20,717 | 21,955 | 18,030 |
2005 | 2004 | 2003 | |
Royalties | 47 | 163 | 124 |
Grants and others | 46 | 45 | 319 |
Total | 93 | 208 | 443 |
2005 | 2004 | 2003 | |
Interest income | 187 | 146 | 284 |
Interest expense | (52) | (75) | (107) |
Total | 135 | 71 | 177 |
2005 | 2004 | 2003 | |
Net loss on sale of Urologix common stock | -- | -- | (123) |
Other income (expense), net | 9 | (74) | (95) |
Total | 9 | (74) | (218) |
2005 | 2004 | 2003 | |
France | (755) | (361) | (8,509) |
Other countries | (206) | (510) | (581) |
Total | (961) | (871) | (9,090) |
2005 | 2004 | 2003 | |
Current income tax expense: | |||
France | 38 | 6 | (22) |
Other countries | (57) | (29) | (78) |
Sub-total current income tax expense | (19) | (23) | (100) |
Deferred income tax (expense) benefit: | |||
France | (90) | (255) | 149 |
Other countries | 5 | - | 65 |
Sub-total deferred income tax (expense) benefit | (85) | (255) | (214) |
Total | (104) | (278) | 114 |
December 31, | |||
2005 | 2004 | ||
Elimination of intercompany profit in inventory | 212 | 199 | |
Other items | 431 | 413 | |
Net operating loss carryforwards | 5,941 | 5,707 | |
Total deferred tax assets | 6,584 | 6,319 | |
Capital leases treated as operating leases for tax | (9) | (4) | |
Exit tax | (161) | (161) | |
Other items | (198) | (88) | |
Total deferred tax liabilities | (368) | (253) | |
Net deferred tax assets | 6,216 | 6,066 | |
Valuation allowance for deferred tax assets | (6,223) | (5,989) | |
Deferred tax assets (liabilities), net of allowance | (7) | 77 |
2005 | 2004 | 2003 | |
French statutory rate | 33.8% | 34.3% | 34.3% |
Research and development tax credit | 7.6% | ||
Income of foreign subsidiaries taxed at different tax rates | 1.5% | 1.9% | 0.1% |
Effect of net operating loss carryforwards and valuation | |||
Allowances | (22.5%) | (31.4%) | (23.5%) |
Non deductible entertainment expenses | (4.9%) | (2.6%) | (0.3%) |
Other | (27.7%) | (34.1%) | (9.3%) |
Effective tax rate | (12.2%) | (31.9%) | (1.3%) |
For the year ended Dec. 31, 2005 | For the year ended Dec. 31, 2004 | For the year ended Dec. 31, 2003 | |||||||
Loss in euro (Numerator) | Shares (Denominator) | Per-Share Amount) | Loss in euro (Numerator) | Shares (Denominator) | Per-Share Amount | Loss in euro (Numerator) | Shares (Denominator) | Per-Share Amount | |
Basic EPS | |||||||||
Loss available to | |||||||||
common Shareholders | (1,065,375) | 7,782,731 | (0.14) | (1,148,792) | 7,781,731 | (0.15) | (8,975,846) | 7,781,731 | (1.15) |
Effect of dilutive securities: | |||||||||
Stock options | 590,843 | 292,479 | 35,572 | ||||||
Diluted EPS | |||||||||
Loss available to | |||||||||
common shareholders, | |||||||||
Including assumed | |||||||||
Conversions | (1,065,375) | 8,373,574 | (0.14) | (1,148,792) | 8,074,210 | (0.15) | (8,975,846) | 7,817,303 | (1.15) |
December 31, | December 31, | |||
2005 Recorded Value | 2005 Estimated Fair Value | 2004 Recorded Value | 2004 Estimated Fair Value | |
Assets: | ||||
Cash and cash equivalents | 8,317 | 8,317 | 9,398 | 9,398 |
Trade accounts and notes receivable, net | 8,025 | 8,025 | 7,722 | 7,722 |
Liabilities: | ||||
Short-term borrowings | 155 | 155 | 525 | 525 |
Trade accounts payable | 3.532 | 3,532 | 2,913 | 2,913 |
Notes payable | 773 | 773 | 762 | 762 |
Long-term debt | 55 | 53 | 6 | 6 |
2005 | 2004 | 2003 | |
Segment operating loss | (1,323) | (830) | (8,121) |
Interest income, net | 135 | 71 | 177 |
Foreign Currency exchange (losses) gains, net | 218 | (38) | (928) |
Other income, net | 9 | (74) | (218) |
Income tax (expense) credit | (104) | (278) | 114 |
Consolidated net loss | (1,065) | (1,149) | (8,976) |
HIFU Division | UDS Division | EDAP TMS (Corporate) | Consolidation | Total consolidated | |
2005 | |||||
External sales of medical devices | 4,260 | 5,982 | 10,242 | ||
External sales of spares parts, | |||||
Supplies & services | 3,685 | 7,025 | 10,710 | ||
Internal segment revenues | 3 | 3,185 | (3,188) | ||
Total sales | 7,948 | 16,192 | (3,188) | 20,952 | |
Warrants granted | (118) | (117) | (235) | ||
Total net sales | 7,830 | 16,075 | (3,188) | 20,717 | |
External other revenues | 14 | 79 | 93 | ||
Internal other revenues | 105 | - | (105) | - | |
Total revenues | 7,949 | 16,154 | (3,293) | 20,810 | |
Total COS | (3,998) | (11,457) | 3,142 | (12,313) | |
Gross margin | 3,951 | 4,697 | (151) | 8,497 | |
R&D | (1,042) | (742) | (1,784) | ||
Selling expenses | (1,983) | (1,775) | (3,758) | ||
G&A | (791) | (1,937) | (1,550) | (4,278) | |
Total expenses | (3,816) | (4,454) | (1,550) | (9,820) | |
Operating income (loss) | 135 | 243 | (1,550) | (151) | (1,323) |
Total Assets | 9,177 | 22,163 | 5,620 | (8,164) | 28,796 |
Capital expenditures | 696 | 645 | 1,341 | ||
Long-lived assets | 2,172 | 3,787 | 59 | 6,018 | |
Goodwill | 645 | 1,767 | 2,412 |
HIFU Division | UDS Division | EDAP TMS (Corporate) | Consolidation | Total consolidated | |
2004 | |||||
External sales of medical devices | 3,733 | 8,189 | 11,922 | ||
External sales of spares parts, | |||||
Supplies & services | 2,915 | 7,291 | 10,206 | ||
Internal segment revenues | 287 | 1,905 | (2,192) | ||
Total sales | 6,935 | 17,385 | (2,192) | 22,128 | |
Warrants granted | (174) | (174) | |||
Total net sales | 6,935 | 17,211 | (2,192) | 21,954 | |
Other revenues | 34 | 174 | 208 | ||
Total revenues | 6,969 | 17,385 | (2,192) | 22,162 | |
Total COS | (3,749) | (12,119) | 2,192 | (13,676) | |
Gross margin | 3,220 | 5,266 | 8,486 | ||
R&D | (817) | (706) | (1,523) | ||
Selling expenses | (1,275) | (2,128) | (3,403) | ||
G&A | (659) | (2,221) | (1,193) | (4,073) | |
Non recurring | (82) | (27) | (208) | (317) | |
Total expenses | (2,833) | (5,082) | (1,401) | (9,316) | |
Operating income (loss) | 387 | 184 | (1,401) | (830) | |
Total Assets | 7,162 | 20,334 | 6,645 | (6,256) | 27,885 |
Capital expenditures | 287 | 844 | 2 | 1,133 | |
Long-lived assets | 1,781 | 4,048 | 31 | 5,860 | |
Goodwill | 645 | 1,767 | 2,412 |
HIFU Division | UDS Division | EDAP TMS (Corporate) | Consolidation | Total consolidated | |
2003 | |||||
External sales of medical devices | 1,148 | 7,364 | 8,512 | ||
External sales of spares parts, | |||||
supplies & services | 1,709 | 7,809 | 9,518 | ||
Internal segment revenues | 3 | 1,967 | (1,970) | — | |
Other revenues | 99 | 342 | 2 | 443 | |
Total revenues | 2,959 | 17,482 | 2 | (1,970) | 18,473 |
Total COS | (2,056) | (12,771) | — | 1,733 | (13,094) |
Gross margin | 903 | 4,711 | — | (237) | 5,379 |
R&D | (2,345) | (725) | (3,070) | ||
Selling expenses | (2,023) | (2,205) | (4,228) | ||
G&A | (747) | (2,005) | (1,353) | (4,105) | |
Non recurring | (1,590) | (463) | (44) | (2,097) | |
Total expenses | (6,705) | (5,398) | (1,397) | — | 13,500 |
Operating income (loss) | (5,802) | (687) | (1,395) | (237) | (8,121) |
Total Assets | 9,432 | 21,050 | 5,238 | (3,810) | 31,910 |
Capital expenditures | 635 | 1,138 | 25 | 1,798 | |
Long-lived assets | 1,951 | 4,054 | 35 | 6,040 | |
Goodwill | 645 | 1,767 | 2,412 |
Allowance for doubtful accounts | Slow-moving inventory | |
Restated balance as of January 1, 2003 | 862 | 1,528 |
Charges to costs and expenses | 41 | 569 |
Deductions: write-off provided in prior periods | (377) | (380) |
Restated balance as of December 31, 2003 | 526 | 1,717 |
Charges to costs and expenses | 204 | 252 |
Deductions: write-off provided in prior periods | (25) | (1,265) |
Restated balance as of December 31, 2004 | 705 | 704 |
Charges to costs and expenses | 274 | 386 |
Deductions: write-off provided in prior periods | (316) | (216) |
Restated balance as of December 31, 2005 | 663 | 874 |
2005 | 2004 | 2003 | |
Income taxes paid (refunds received) | (66) | (82) | (560) |
Interest paid | 7 | 19 | 21 |
Interest received | 119 | 120 | 223 |
Non-cash transactions: | 2005 | 2004 | 2003 |
Capital lease obligations incurred | 859 | 998 | 792 |