ICON Public Company
Annual Report 2008

Plain-text annual report

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) (cid:2) Registration statement pursuant to Section 12(b) or (g) of the Securities Exchange Act of 1934 OR (cid:3) Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (cid:2) Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. OR For the fiscal year ended: December 31, 2008 Commission File No. 000-29714 ICON PUBLIC LIMITED COMPANY (Exact name of Registrant as Specified in its Charter) Ireland (Jurisdiction of Incorporation or Organization) SOUTH COUNTY BUSINESS PARK, LEOPARDSTOWN, DUBLIN 18, IRELAND. (Address of principal executive offices) CIARAN MURRAY, CFO SOUTH COUNTY BUSINESS PARK LEOPARDSTOWN, DUBLIN 18, IRELAND. CIARAN.MURRAY@ICONPLC.COM 0011-353-1-291-2000 (Name, telephone number, email and/or facsmile number and address of Company contact person) Securities registered or to be registered pursuant to Section 12(b) of the Act: Title of each class AMERICAN DEPOSITORY SHARES, REPRESENTING ORDINARY SHARES, PAR VALUE A€ 0.06 EACH ORDINARY SHARES, PAR VALUE A€ 0.06 EACH Name of exchange on which registered NASDAQ GLOBAL SELECT MARKET Securities registered or to be registered pursuant to Section 12(g) of the Act: Title of each class NONE Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: NONE (Title of Class) Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: 58,518,195 Ordinary Shares. Indicate by check mark if the registrant is a well-known seasoned issuer, as determined in Rule 405 of the Securities Act. Yes (cid:3) No (cid:2) If this report is an annual or transition report, indicate by check mark if registrant is not required to file reports pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934. Yes (cid:2) No (cid:3) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days: Yes (cid:3) No (cid:2) Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non- accelerated filer Accelerated filer (cid:2) Large Accelerated filer (cid:3) Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing: International Financial Reporting Standards as issued (cid:2) U.S. GAAP (cid:3) by the International Accounting Standards Board Non-accelerated filer (cid:2) Other (cid:2) If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow: Item 17 (cid:2) Item 18 (cid:2) If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes (cid:2) No (cid:3) TABLE OF CONTENTS General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cautionary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 1 1 PART I Item 1. Item 2. Item 3. Item 4. Item 5. Item 6. Item 7. Item 8. Item 9. Item 10. Item 11. Item 12. Item 13. Item 14. Item 15. Item 16. 2 Identity of Directors, Senior Management and Advisors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Offer Statistics and Expected Timetable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Key Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Information on the Company. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Operating and Financial Review and Prospects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Directors, Senior Management and Employees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Major Shareholders and Related Party Transactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Financial Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 The Offer and the Listing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Quantitative and Qualitative Disclosures about Market Risk . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Description of Securities Other than Equity Securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 PART II Defaults, Dividend Arrearages and Delinquencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Material Modifications to the Rights of Security Holders and Use of Proceeds . . . . . . . . . . . . . . 50 Controls and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Reserved . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Item 17. Item 18. Item 19. Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Financial Statements and Exhibits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 PART III General As used herein, “ICON plc”, “ICON”, the “Company” and “we” or “us” refer to ICON public limited company and its consolidated subsidiaries, unless the context requires otherwise. Unless otherwise indicated, ICON plc’s financial statements and other financial data contained in this Form 20-F are presented in United States dollars (“$”) and are prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). In this Form 20-F, references to “U.S. dollars”, “U.S.$” or “$” are to the lawful currency of the United States, references to “pounds sterling”, “sterling”, “£”, “pence” or “p” are to the lawful currency of the United Kingdom, references to “Euro” or “A€ ” are to the European single currency adopted by sixteen members of the European Union (including the Republic of Ireland, France, Germany, Spain, Italy, Finland and the Netherlands). ICON publishes its consolidated financial statements in U.S. dollars. On July 21, 2008, the Company’s shareholders approved a bonus issue of ordinary shares (the “Bonus Issue”) to shareholders of record as of the close of business on August 8, 2008 (the “Record Date”). The Bonus Issue provided for each shareholder to receive one bonus ordinary share for each ordinary share held as of the Record Date, effecting the equivalent of a 2-for-1 stock split. The Bonus shares were issued on August 11, 2008, to Ordinary Shareholders and on August 12, 2008, to holders of American Depositary Shares (“ADSs”). The trading price of ICON’s ADSs was adjusted on NASDAQ to effect the Bonus Issue prior to the opening of trading on August 13, 2008. All outstanding ordinary share amounts referenced in the consolidated financial statements and the notes thereto have been retrospectively restated to give effect to the Bonus Issue as if it had occurred as of the date referenced. On September 29, 2006, ICON’s shareholders approved a bonus issue of ordinary shares (the “Bonus Issue”) to shareholders of record as of the close of business on October 13, 2006 (the “Record Date”). The Bonus Issue provided for each shareholder to receive one bonus ordinary share for each ordinary share held as of the Record Date, effecting the equivalent of a 2-for-1 stock split. The Bonus shares were issued on October 16, 2006, to ordinary shareholders and on October 23, 2006 to holders of American Depositary Shares (“ADSs”). The trading price of ICON’s ADSs was adjusted on NASDAQ to effect the Bonus Issue prior to the opening of trading on October 24, 2006. All outstanding ordinary share amounts referenced in the consolidated financial statements and the notes thereto have been retrospectively restated to give effect to the Bonus Issue as if it had occurred as of the date referenced. Cautionary Statement Statements included herein which are not historical facts are forward looking statements. Such forward looking statements are made pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995 (the “PSLRA”). The forward looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, our results could be materially affected. The risks and uncertainties include, but are not limited to, dependence on the pharmaceutical industry and certain clients, the need to regularly win projects and then to execute them efficiently, the challenges presented by rapid growth, competition and the continuing consolidation of the industry, the dependence on certain key executives and other factors identified in the Company’s Securities and Exchange Commission filings. The Company has no obligation under the PSLRA to update any forward looking statements and does not intend to do so. 1 PART I Item 1. Identity of Directors, Senior Management and Advisors. Not applicable. Item 2. Offer Statistics and Expected Timetable. Not applicable. Item 3. Key Information. Selected Historical Consolidated Financial Data for ICON plc The following selected financial data set forth below are derived from ICON’s consolidated financial statements and should be read in conjunction with, and are qualified by reference to, Item 5 “Operating and Financial Review and Prospects” and ICON’s consolidated financial statements and related notes thereto included elsewhere in this Form 20-F. Year ended May 31 2004 2005 7 month Period ended December 31, Year ended December 31, Year ended December 31, Year ended December 31, 2005 2006 2007 2008 (in thousands, except share and per share data) Statement of Operations Data: Gross revenue . . . . . . . . . . . . . . . . Reimbursable expenses (1) . . . . . . . . . . . . . . . . Net revenue. . . . . . . . . . . . . . . . . . . Costs and expenses: Direct costs . . . . . . . . . . . . . . . . . Selling, general and administrative . . . . . . . . . . . . . Depreciation and $ 443,875 $ 469,583 $ 275,586 $ 649,826 $ 867,473 $ 1,209,451 (146,952) 296,923 (142,925) 326,658 (73,636) 201,950 (194,229) 455,597 (236,751) 630,722 (344,203) 865,248 162,562 179,661 114,004 88,807 103,784 62,276 amortization . . . . . . . . . . . . . . 11,171 Share based compensation (2) . . . . . . . . . . Other charges (4) . . . . . . . . . . . . — — 13,331 — 11,275 8,094 6,024 — Total costs and 256,263 136,569 14,949 — — 354,479 489,238 187,993 248,778 19,008 27,728 — — — — expenses . . . . . . . . . . . . . . . . . . . 262,540 308,051 190,398 407,781 561,480 765,744 Income from operations . . . . . . . . . . . . . . . . . . Net interest income / (expense) . . . Income before provision for income taxes . . . . . . . . . . . . . . . . Provision for income taxes . . . . . . . . . . . . . . . . . . . . . . Minority interest . . . . . . . . . . . . . . . Net income . . . . . . . . . . . . . . . . . . . Net income per ordinary share (3): Basic . . . . . . . . . . . . . . . . . . . . . . Diluted . . . . . . . . . . . . . . . . . . . . Weighted average number of ordinary shares outstanding: Basic . . . . . . . . . . . . . . . . . . . . . . Diluted . . . . . . . . . . . . . . . . . . . 34,383 288 18,607 979 11,552 1,272 47,816 3,640 69,242 2,738 99,504 (1,224) 34,671 19,586 12,824 51,456 71,980 98,280 (8,929) — 25,742 0.49 0.47 $ $ $ $ $ $ (5,852) (189) 13,545 0.24 0.24 (5,396) (10) 7,418 0.13 0.13 (12,924) (228) 38,304 0.68 0.66 $ $ $ (15,830) (187) 55,963 0.97 0.94 $ $ $ (19,967) (193) 78,120 1.34 1.30 $ $ $ $ $ $ 53,070,124 54,812,652 55,440,812 56,613,780 55,880,424 56,990,168 56,629,970 57,726,668 57,410,544 59,495,928 58,245,240 60,221,587 2 As of May 31, As of December 31, 2004 2005 2005 2006 2007 2008 (in thousands) Balance Sheet Data: Cash and cash equivalents . . . $ 55,678 23,085 Short term investments . . . . 113,813 Working capital . . . . . . . . . 335,323 Total assets . . . . . . . . . . . . — Total debt . . . . . . . . . . . . . Long term government grants . 1,411 Shareholders’ equity . . . . . . . $ 216,760 $ 56,341 22,034 125,288 347,553 — 1,257 $ 233,066 $ 59,509 22,809 132,312 349,067 4,856 1,160 $ 241,558 $ 63,039 39,822 160,321 476,341 5,000 1,170 $ 302,738 $ 76,881 41,752 193,271 693,138 94,829 1,179 $ 388,400 $ 58,378 42,726 185,957 867,285 105,379 1,386 $ 456,366 (1) Reimbursable expenses are comprised of investigator payments and certain other costs reimbursed by clients under terms specific to each of ICON's contracts. See Note 2 (d) to the Audited Consolidated Financial Statements. (2) $6.0 million share-based compensation expensed during the period ended December 31, 2005, was recorded in relation to the transfer of 576,000 shares from the founders of the Company to the Chief Executive Officer. (3) Net income per ordinary share is based on the weighted average number of outstanding ordinary shares. Diluted net income per share includes potential ordinary shares from the exercise of options. (4) Other operating charges of $11.3 million were recorded in the year ended May 31, 2005. These charges related to the recognition of an impairment in the carrying value of our investment in the central laboratory, a write-down of certain fixed assets and the lease termination and exit costs associated with the consolidation of some of our office facilities in the US. Risk Factors We are dependent on the continued outsourcing of research and development by the pharmaceutical, biotechnology and medical device industries. We are dependent upon the ability and willingness of the pharmaceutical, biotechnology and medical device companies to continue to spend on research and development and to outsource the services that we provide. We are therefore subject to risks, uncertainties and trends that affect companies in these industries. We have benefited to date from the tendency of pharmaceutical, biotechnology and medical device companies to outsource clinical research projects. Any downturn in these industries or reduction in spending or outsourcing could adversely affect our business. For example, if these companies expanded upon their in-house clinical or development capabilities, they would be less likely to utilize our services. In addition, if governmental regulations were changed, they could affect the ability of our clients to operate profitably, which may lead to a decrease in research spending and therefore this could have a material adverse effect on our business. The current economic and financial downturn may have a material adverse effect on our results. Many of the world’s largest economies and financial institutions currently face extreme financial difficulty, including a decline in asset prices, liquidity problems and limited availability of credit. It is uncertain how long this downturn will last, but many countries are concerned that their economies may enter a deep and prolonged recession. Such difficult economic times may have a material adverse effect on our revenues, results of operations, financial condition and ability to raise capital. We depend on a limited number of clients and a loss of or significant decrease in business from them could affect our business. We have in the past and may in the future derive a significant portion of our net revenue from a relatively limited number of clients. A loss of, or a significant decrease in business from any one or more of such clients could have a material adverse effect on our business. During the year ended December 31, 2008, 29% of our net revenue was derived from our top five clients. During 2008, no client contributed more than 10% of net revenues. During the year ended December 31, 2007, 30% of our net revenue was derived from our top five clients. During 2007, no client contributed 3 more than 10% of net revenues. During the year ended December 31, 2006, 35% of our net revenue was derived from our top five clients. During 2006, no client contributed more than 10% of net revenues. If our clients discontinue using our services, or cancel or discontinue projects, our revenue will be adversely affected and we may not receive their business in the future or may not be able to attract new clients. Our clients may discontinue using our services completely or cancel some projects either without notice or upon short notice. The termination or delay of a large contract or of multiple contracts could have a material adverse effect on our revenue and profitability. Historically, clients have cancelled or discontinued projects and may in the future cancel their contracts with us for reasons including: • • • • • the failure of products being tested to satisfy safety or efficacy requirements; unexpected or undesired clinical results of the product; a decision that a particular study is no longer necessary; poor project performance, insufficient patient enrollment or investigator recruitment; or production problems resulting in shortages of the drug. If we lose clients, we may not be able to attract new ones, and if we lose individual projects, we may not be able to replace them. We compete against many companies and research institutions that may be larger or more efficient than we are. This may preclude us from being given the opportunity to bid, or may prevent us from being able to competitively bid on and win new contracts. The market for Contract Research Organizations (“CROs”) is highly competitive. We primarily compete against in-house departments of pharmaceutical companies and other CROs including Covance Inc., i3 Research (United Health Group Incorporated), Kendle International Inc., MDS Inc., Omnicare Inc., PAREXEL International Corporation, Pharmaceutical Product Development Inc., PharmaNet Development Group Inc., PRA International Inc. and Quintiles Transnational Corporation. Some of these competitors have substantially greater capital, research and development capabilities and human resources than we do. As a result, they may be selected as preferred vendors of our clients or potential clients for all projects or for significant projects, or they may be able to price projects more competitively than us. Any of these factors may prevent us from getting the opportunity to bid on new projects or prevent us from being competitive in bidding on new contracts. Our quarterly results are dependent upon a number of factors and can fluctuate from quarter to quarter. Our results of operations in any quarter can fluctuate depending upon, among other things, the number and scope of ongoing client projects, the commencement, postponement, variation and cancellation or termination of projects in the quarter, the mix of revenue, cost overruns, employee hiring and other factors. Our net revenue in any period is directly related to the number of employees and the percentage of these employees who were working on projects and billed to the client during that period. We may be unable to compensate for periods of underutilization during one part of a fiscal period by augmenting revenues during another part of that period. We believe that operating results for any particular quarter are not necessarily a meaningful indication of future results. Approximately 71% of our net revenue is earned from long-term fixed-fee contracts. We would lose money in performing these contracts if the costs of performance exceed the fixed fees for these projects. Approximately 71% of our net revenue is earned from long-term fixed fee contracts. Revenues on these contracts are agreed on contract initiation between the Company and the customer and are based on estimated time inputs to the contract. Factors considered in estimating time requirements include the complexity of the study, the number of geographical sites where trials are to be conducted and the number of patients to be recruited at each site. The Company regularly reviews the estimated hours on each contract to determine if the budget accurately reflects the agreed tasks to be performed taking into account the state of progress at the time of review. The Company further 4 ensures that changes in scope are appropriately monitored and change orders for additional revenue are promptly negotiated for the additional work. If we were to fail to recognise and negotiate change orders for changes in the resources required or the scope of the work to be performed the Company could lose money if the costs of performance of these contracts exceeded their fixed fees. If we fail to attract or retain qualified staff, our performance may suffer. Our business, future success and ability to expand operations depends upon our ability to attract, hire, train and retain qualified professional, scientific and technical operating staff. We compete for qualified professionals with other CROs, temporary staffing agencies and the in-house departments of pharmaceutical, biotechnology and medical device companies. Although we have not had any difficulty attracting or retaining qualified staff in the past, there is no guarantee that we will be able to continue to attract a sufficient number of clinical research professionals at an acceptable cost. We are highly dependent on information technology. If our systems fail or are unreliable our operations may be adversely impacted. The efficient operation of our business depends on our information technology infrastructure and our management information systems. Our information technology infrastructure includes both third party solutions and applications designed and maintained internally. Since our Company operates on multiple platforms, the failure of our information technology infrastructure and/or our management information systems to perform could severely disrupt our business and adversely affect our results of operation. In addition, our information technology infrastructure and/or our management information systems are vulnerable to damage or interruption from natural or man-made disasters, terrorist attacks, computer viruses or hackers, power loss, or other computer systems, Internet telecommunications or data network failures. Any such interruption could adversely affect our business and results of operations. Failure to comply with the regulations of the U.S. Food and Drug Administration and other regulatory authorities could result in substantial penalties and/or loss of business. The U.S. Food and Drug Administration, or FDA, and other regulatory authorities inspect us from time to time to ensure that we comply with their regulations and guidelines, including environmental and health and safety matters. In addition, we must comply with the applicable regulatory requirements governing the conduct of clinical trials in all countries in which we operate. If we fail to comply with any of these requirements we could suffer: • • • • • the termination of any research; the disqualification of data; the denial of the right to conduct business; criminal penalties; and other enforcement actions. Our exposure to exchange rate fluctuations could adversely affect our results of operations. We derived approximately 56% of our consolidated net revenue in the year ended December 31, 2008, from our operations outside of the United States. Our financial statements are presented in U.S. dollars. Accordingly, changes in exchange rates between the U.S. dollar and other currencies in which we report local results, including the pound sterling and the euro, will affect the translation of a subsidiary’s financial results into U.S. dollars for purposes of reporting our consolidated financial results. In addition, our contracts with our clients are sometimes denominated in currencies other than the currency in which we incur expenses related to such contracts. Where expenses are incurred in currencies other than those in which contracts are priced, fluctuations in the relative value of those currencies could have a material adverse effect on our results of operations. This risk is partially mitigated by clauses in certain of our contracts which allow for price renegotiation with our clients if changes in the relative value of those currencies exceed predetermined tolerances. We regularly review our currency exchange exposure and on occasion hedge a portion of this exposure using forward exchange contracts. 5 Liability claims brought against us could result in payment of substantial damages to plaintiffs and decrease our profitability. We contract with physicians who serve as investigators in conducting clinical trials to test new drugs on their patients. This testing creates the risk of liability for personal injury to or death of the patients. Although investigators are generally required by law to maintain their own liability insurance, we could be named in lawsuits and incur expenses arising from any professional malpractice actions against the investigators with whom we contract. To date, we have not been subject to any liability claims that are expected to have a material effect on us. Indemnifications provided by our clients against the risk of liability for personal injury to or death of the patients vary from client to client and from trial to trial and may not be sufficient in scope or amount or the providers may not have the financial ability to fulfill their indemnification obligations. Furthermore, we would be liable for our own negligence and that of our employees. In addition, we maintain an appropriate level of worldwide Professional Liability/Error and Omissions Insurance. The amount of coverage we maintain depends upon the nature of the trial. We may in the future be unable to maintain or continue our current insurance coverage on the same or similar terms. If we are liable for a claim that is beyond the level of insurance coverage, we may be responsible for paying all or part of any award. We may lose business opportunities as a result of health care reform and the expansion of managed care organizations. Numerous governments, including the U.S. government and governments outside of the U.S., have undertaken efforts to control growing health care costs through legislation, regulation and voluntary agreements with medical care providers and drug companies. If these efforts are successful, pharmaceutical, biotechnology and medical device companies may react by spending less on research and development and therefore this could have a material adverse effect on our business. For instance, in the past the U.S. Congress has entertained several comprehensive healthcare reform proposals. The proposals were generally intended to expand healthcare coverage for the uninsured and reduce the growth of total healthcare expenditures. While the U.S. Congress has not yet adopted any comprehensive reform proposals, members of Congress may raise similar proposals in the future. We are unable to predict the likelihood that healthcare reform proposals will be enacted into law. In addition to healthcare reform proposals, the expansion of managed care organizations in the healthcare market may result in reduced spending on research and development. Managed care organizations’ efforts to cut costs by limiting expenditures on pharmaceuticals and medical devices could result in pharmaceutical, biotechnology and medical device companies spending less on research and development. If this were to occur, we would have fewer business opportunities and our revenues could decrease, possibly materially. We may lose business as a result of changes in the regulatory environment Various regulatory bodies throughout the world may enact legislation which could introduce changes to the regulatory environment for drug development and research. The adoption and implementation of such legislation is difficult to predict and therefore could have a material adverse effect on our business. We may not be able to successfully develop and market or acquire new services. We may seek to develop and market new services that complement or expand our existing business or expand our service offerings through acquisition. If we are unable to develop new services and/or create demand for those newly developed services, or expand our service offerings through acquisition, our future business, results of operations, financial condition, and cash flows could be adversely affected. We rely on third parties for important services. We depend on third parties to provide us with services critical to our business. The failure of any of these third parties to adequately provide the required services could have a material adverse effect on our business. 6 We may make acquisitions in the future, which may lead to disruptions to our ongoing business. We have made a number of acquisitions and will continue to review new acquisition opportunities. If we are unable to successfully integrate an acquired company, the acquisition could lead to disruptions to the business. The success of an acquisition will depend upon, among other things, our ability to: integrate acquired personnel; assimilate the operations and services or products of the acquired company; • • • • • minimize the diversion of management’s attention from other business concerns. retain and motivate key employees; retain customers; and Acquisitions of foreign companies may also involve additional risks, including assimilating differences in foreign business practices and overcoming language and cultural barriers. In the event that the operations of an acquired business do not meet our performance expectations, we may have to restructure the acquired business or write-off the value of some or all of the assets of the acquired business. Failure to raise sufficient finance may affect our ability to sustain future development of the business We have financed our operations and growth since inception primarily with cash flows from operations, net proceeds of $49.1 million raised in our initial public offering in May 1998, net proceeds of $44.3 million raised in our public offering in August 2003 and net borrowings of $105.4 million. Although we have not had difficulty in raising finance in the past, there is no guarantee that we will be able to raise sufficient capital, at an appropriate cost to the Company, to sustain future development of the business. We rely on our interactive voice response systems to provide accurate information regarding the randomization of patients and the dosage required for patients enrolled in the trials. We develop and maintain computer run interactive voice response systems to automatically manage the randomization of patients in trials, assign the study drug, and adjust the dosage when required for patients enrolled in trials we support. An error in the design, programming or validation of these systems could lead to inappropriate assignment or dosing of patients which could give rise to patient safety issues, invalidation of the trial, liability claims against the Company or all three. We rely on various control measures to mitigate the risk of a serious adverse event resulting from healthy volunteer Phase I trials. We conduct healthy volunteer Phase I trials including first-into-man trials for new clinical entities in the UK and the US. Due to the experimental nature of these studies, serious adverse events may arise. We mitigate such events by following Good Clinical Practice and ensuring appropriately trained and experienced clinical physicians are managing these trials and that internal Standard Operating Procedures and client protocols are rigorously adhered to. We also ensure that a signed contract is in place with the client in advance of clinical dosing with appropriate indemnifications and insurance coverage. We maintain our own no-faults clinical trial insurance. Following our internal review and submission, an Independent Ethics committee approves the study protocol and appropriate approval is obtained from the relevant regulatory body. 7 Item 4. Information on the Company. General We are a contract research organization (“CRO”), providing outsourced development services on a global basis to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies. In a highly fragmented industry, we are one of a small number of companies with the capability and expertise to conduct clinical trials in all major therapeutic areas on a global basis. At December 31, 2008, we had 6,975 employees, in 71 locations in 38 countries, providing Phase I - IV Clinical Trial Management, Drug Development Support Services, Data Management and Biostatistical, Central Laboratory and Imaging Services. We have the operational flexibility to provide development services on a stand-alone basis or as part of an integrated “full service” solution. Headquartered in Dublin, Ireland, we began operations in 1990 and have expanded our business through internal growth and strategic acquisitions. For the year ended December 31, 2008, we derived approximately 43.8%, 47.8 % and 8.4 % of our net revenue in the United States, Europe and Rest of World, respectively. During the year ended December 31, 2008, we commenced operations in Edinburgh, Scotland; Bogota, Colombia and New Dehli, India. On February 11, 2008, the Company acquired 100% of the common stock of Healthcare Discoveries Inc., for an initial cash consideration of $10.9 million, excluding costs of acquisition. Healthcare Discoveries, located in San Antonio, Texas, is engaged in the provision of Phase I clinical trial management services. Certain performance milestones were built into the acquisition agreement requiring payment of additional consideration of up to $10.0 million if these milestones were achieved during the year ended December 31, 2008. No amounts have been accrued at December 31, 2008, as the milestones have not been achieved. On November 14, 2008, the Company acquired 100% of the common stock of Prevalere Life Sciences Inc. (“Prevalere”), for an initial cash consideration of $36.8 million, excluding costs of acquisition. Prevalere, located in Whitesboro, New York, is a leading provider of bioanalytical and immunoassay services to pharmaceutical and biotechnology companies. Certain performance milestones were built into the acquisition agreement requiring potential additional consideration of up to $8.2 million if these milestones are achieved during the years ended December 31, 2008 and 2009. Additional consideration of $5.0 million has been accrued at December 31, 2008, in respect of the milestones for the year ended December 31, 2008. No amounts have been accrued for additional consideration potentially payable in respect of the milestones for the year ended December 31, 2009. On July 1, 2004, the Company acquired 70% of the common stock of Beacon Biosciences Inc. (“Beacon”), a leading specialist CRO, which provides a range of medical imaging services to the pharmaceutical, biotechnology and medical device industries, for an initial cash consideration of $9.9 million, excluding costs of acquisition. On December 31, 2008, the remaining 30% of the common stock was acquired by the Company for $17.4 million, excluding costs of acquisition. Certain performance milestones were built into the acquisition agreement for the remaining 30% of Beacon requiring potential additional consideration of up to $3.0 million if these milestones are achieved during the year ended December 31, 2009. At December 31, 2008, no amounts have been accrued in respect of the potential additional consideration. On July 9, 2007, ICON plc entered into a five year committed multi-currency facility agreement for A€ 35 million ($48.9 million) with The Governor and Company of the Bank of Ireland. Our obligations under the facility are secured by certain composite guarantees, indemnities and pledges in favor of the bank. The facility bears interest at an annual rate equal to EURIBOR plus a margin. On July 10, 2007, the Company drew down A€ 29.5 million ($41.2 million) of the facility to fund the acquisition of DOCS International. On October 15, 2007, the remaining A€ 5.5 million ($7.7 million) of the facility was drawn down to fund expenditure on the expansion of the Company’s facility in Dublin, Republic of Ireland. On January 2, 2009, an additional four year committed credit facility was negotiated with The Governor and Company of the Bank of Ireland for $25 million. The facility bears interest at LIBOR plus a margin and is secured by certain composite guarantees, indemnities and pledges in favor of the bank. 8 On October 17, 2007, an uncommitted credit facility was negotiated with Allied Irish Banks plc, for A€ 30 million ($41.9 million). Interest is calculated at the EUR interbank rate plus a margin. The facility is secured by the same composite guarantees and indemnities in place for the Bank of Ireland committed facility. The funds were used to refinance overdraft facilities in place to fund expenditure on the expansion of the Dublin facility. On January 8, 2008, the facility with Allied Irish Banks plc was increased to A€ 50 million ($69.9 million). On December 22, 2008, committed credit facilities were negotiated with Allied Irish Bank plc for $75 million. The facilities comprise a one year Euro facility of approximately A€ 20 million ($28.0 million), with the balance comprising a three year US dollar facility. The Euro facility bears interest at EURIBOR plus a margin and the US dollar facility bears interest at LIBOR plus a margin. Both facilities are secured by certain composite guarantees and pledges in favour of the bank. These facilities replace the uncommitted facilities negotiated on January 8, 2008. $28.4 million of these facilities were used to fund the acquisition of Prevalere with the remaining balance used to refinance the previous drawn uncommitted facilities. On February 4, 2008, an uncommitted credit facility was negotiated with Citibank N.A, for $30 million. Interest is calculated at the London Interbank Market rate plus a margin. $12.0 million of this facility was drawn down in February 2008 to fund the acquisition of Healthcare Discoveries. On September 30, 2008, the $12.0 million previously drawn was repaid in full. At December 31, 2008, this facility remained un-drawn and available to the Company. The average margin payable on the above mentioned facilities is 1.70 per cent. On July 21, 2008, the Company’s shareholders approved a bonus issue of ordinary shares (the “Bonus Issue”) to shareholders of record as of the close of business on August 8, 2008 (the “Record Date”). The Bonus Issue provided for each shareholder to receive one bonus ordinary share for each ordinary share held as of the Record Date, effecting the equivalent of a 2-for-1 stock split. The Bonus shares were issued on August 11, 2008, to Ordinary Shareholders and on August 12, 2008, to holders of American Depositary Shares (“ADSs”). The trading price of ICON’s ADSs was adjusted on NASDAQ to effect the Bonus Issue prior to the opening of trading on August 13, 2008. All outstanding ordinary share amounts referenced in the consolidated financial statements and the notes thereto have been retrospectively restated to give effect to the Bonus Issue as if it had occurred as of the date referenced. On September 29, 2006, ICON’s shareholders approved a bonus issue of ordinary shares (the “Bonus Issue”) to shareholders of record as of the close of business on October 13, 2006 (the “Record Date”). The Bonus Issue provided for each shareholder to receive one bonus ordinary share for each ordinary share held as of the Record Date, effecting the equivalent of a 2-for-1 stock split. The Bonus shares were issued on October 16, 2006, to Ordinary Shareholders and on October 23, 2006, to holders of American Depositary Shares (“ADSs”). The trading price of ICON’s ADSs was adjusted on NASDAQ to effect the Bonus Issue prior to the opening of trading on October 24, 2006. All outstanding ordinary share amounts referenced in the consolidated financial statements and the notes thereto have been retrospectively restated to give effect to the Bonus Issue as if it had occurred as of the date referenced. ICON plc’s principal executive office is located at: South County Business Park, Leopardstown, Dublin 18, Republic of Ireland. The contact telephone number of this office is 353 (1) 291 2000. Industry Overview The CRO industry provides independent product development services for the pharmaceutical, biotechnology and medical device industries. Companies in these industries outsource product development services to CROs in order to manage the drug development process more efficiently and to cost-effectively maximize the profit potential of both patent-protected and generic products. The CRO industry has evolved since the 1970s from a small number of companies that provided limited clinical services to a larger number of CROs that offer a range of services that encompass the entire research and development process, including pre-clinical development, clinical trials management, clinical data management, study design, biostatistical analysis, post marketing surveillance, central laboratory and regulatory affairs services. CROs are required to provide these services in accordance with good clinical and laboratory practices, as governed by the applicable regulatory authorities. The CRO industry is highly fragmented, consisting of several hundred small, limited-service providers and a limited number of medium-sized and large CROs with global operations. Although there are few barriers to entry for 9 small, limited-service providers, we believe there are significant barriers to becoming a CRO with global capabilities. Some of these barriers include the infrastructure and experience necessary to serve the global demands of clients, the ability to manage simultaneously complex clinical trials in numerous countries, broad therapeutic expertise and the development and maintenance of the complex information technology systems required to integrate these capabilities. In recent years, the CRO industry has experienced consolidation, resulting in the emergence of a select group of CROs that have the capital, technical resources, integrated global capabilities and expertise to conduct multiple phases of clinical trials on behalf of pharmaceutical, biotechnology and medical device companies. We believe that some large pharmaceutical companies, rather than utilizing many CRO service providers, are selecting a limited number of CROs who are invited to bid for projects. We believe that this trend will further concentrate the market share among CROs with a track record of quality, speed, flexibility, responsiveness, global capabilities and overall development experience and expertise. New Drug Development – Ethical Pharmaceuticals and Biologics - An Overview Before a new drug or biologic may be marketed, it must undergo extensive testing and regulatory review in order to determine that it is safe and effective. The following discussion primarily relates to the FDA approval process for such products. Similar procedures must be followed for product development with global regulatory agencies. The stages of this development process are as follows: Preclinical Research (approximately 1 to 3.5 years). “In vitro” (test tube) and animal studies must be conducted in accordance with applicable regulations to establish the relative toxicity of the drug over a wide range of doses and to detect any potential to cause birth defects or cancer. If results warrant continuing development of the drug or biologic, the manufacturer will file for an Investigational New Drug Application, or IND, which must become effective by the FDA before starting the proposed clinical studies. Clinical Trials (approximately 3.5 to 6 years). Phase I (6 months to 1 year). Consists of basic safety and pharmacology testing in 20 to 80 human subjects, usually healthy volunteers, and includes studies to determine how the drug works, if it is safe, how it is affected by other drugs, where it goes in the body, how long it remains active and how it is broken down and eliminated from the body. Phase II (1 to 2 years). Includes basic efficacy (effectiveness) and dose-range testing in a limited patient population (usually) 100 to 200 patients to help determine the best effective dose, confirm that the drug works as expected, and provide additional safety data. If the Phase II results are satisfactory and no clinical hold is enforced by the FDA, the Sponsor may proceed to Phase III studies. Phase III (2 to 3 years). Efficacy and safety studies in hundreds or thousands of patients at many investigational sites (hospitals and clinics). These studies can be placebo-controlled trials, in which the new drug is compared with a “sugar pill”, or studies comparing the new drug with one or more drugs with established safety and efficacy profiles in the same therapeutic category. TIND (may span late Phase II, Phase III, and FDA review). When results from Phase II or Phase III show special promise in the treatment of a serious condition for which existing therapeutic options are limited or of minimal value, the FDA may allow the Sponsor to make the new drug or biologic available to a larger number of patients through the regulated provision of a Treatment Investigational New Drug, or TIND. Although less scientifically rigorous than a controlled clinical trial, a TIND may enroll and collect a substantial amount of data from tens of thousands of patients. NDA or BLA Preparation and Submission. Upon completion of Phase III trials, the Sponsor assembles the statistically analyzed data from all phases of development into a single large submission along with the Chemistry and Manufacturing and preclinical data and the proposed labeling into the New Drug Application (NDA), or Biologics License Application (BLA) which today comprises, on average, approximately 100,000 pages. FDA Review & Approval of NDA or BLA (1 to 1.5 years). Data from all phases of development (including a TIND) is scrutinized to confirm that the manufacturer has complied with all applicable regulations and that the drug or biologic is safe and effective for the specific use (or “indication”) under study. The FDA may refuse to accept the NDA or BLA if the Sponsor’s application has certain administrative or content criteria which do meet FDA standards. The FDA may also deny approval of the drug or biologic product if applicable regulatory requirements are not satisfied. 10 Post-Marketing Surveillance and Phase IV Studies. Federal regulation requires the Sponsor to collect and periodically report to the FDA additional safety and efficacy data on the drug or biologic for as long as the Sponsor markets it (post-marketing surveillance). If the product is marketed outside the U.S., these reports must include data from all countries in which the drug is sold. Additional studies (Phase IV) may be undertaken after initial approval to find new uses for the drug, to test new dosage formulations, or to confirm selected non-clinical benefits, e.g., increased cost-effectiveness or improved quality of life. Additionally, FDA and other regulatory agencies are requiring Sponsors of marketed drugs or biologics to prepare Risk Management plans which are aimed at assessing areas of product risk and plans for managing such risk should they occur. The FDA Amendment Act of 2007 has imposed additional regulatory requirements on Sponsors which address product safety, to conduct post-marketing surveillance studies and to submit the clinical trial information, including clinical study results, of investigational and marketed products to a databank managed and maintained by the National Institutes of Health. The information is accessible to the public via the worldwide web. This action was taken as a result to increase “public transparency” of Sponsor’s clinical studies and respective clinical results. Key Trends Affecting the CRO Industry CROs derive substantially all of their revenue from the research and development expenditures of pharmaceutical, biotechnology and medical device companies. Based on industry surveys and investment analyst research, we estimate that clinical development expenditures outsourced by pharmaceutical and biotechnology companies worldwide in 2007 was approximately $18 billion. We believe that the following trends create further growth opportunities for global CROs, although there is no assurance that growth will materialize. Innovation driving new Drug Development activity. Technologies such as combinational chemistry and high throughput screening, together with improved understanding of disease pathology (driven by scientific advances such as the mapping of the human genome) have greatly increased the number of new drug candidates being investigated in early development and greatly broadened the number of biological mechanisms being targeted by such candidates. Arising from this innovation, funding for research and development, particularly by biotechnology companies, grew strongly in recent years. This lead to significant increased activity in both Preclinical and Phase I development which we believe will lead to more treatments in Phase II-III clinical trials. As the number of trials that need to be performed increases, we believe that drug developers will increasingly rely on CROs to manage these trials in order to continue to focus on drug discovery. However, this growth in Preclinical and Phase I development activity in the near term may be impacted by the current global economic downturn and the reduction in the availability of funding for research and development activities, in particular for smaller biotech companies. Declining productivity within Research and Development programs. Whilst the total number of compounds that have entered clinical development has risen over the last few years, the number of novel drugs that have successfully been approved for marketing has remained relatively stable. Pharmaceutical and biotechnology companies have responded in a number of ways including looking to extend the product life cycle of existing drugs and initiating programs to drive efficiency in the development process. One example of this has been the efforts to achieve a more seamless transition across development phases, particularly Phase I-III. In parallel regulatory initiatives such as the FDA’s “Critical Path” and the emergence of techniques such as adaptive trial design are focused on ensuring unsafe or ineffective drugs are eliminated from the development process earlier, allowing effective treatments to get to patients quicker at potentially reduced development costs. Pressure to Accelerate Time to Markets; Globalization of the Marketplace. Reducing product development time maximizes the client’s potential period of patent exclusivity, which in turn maximizes potential economic returns. We believe that clients are increasingly using CROs that have the appropriate expertise to improve the speed of product development to assist them in improving economic returns. In addition, applying for regulatory approval in multiple markets and for multiple indications simultaneously, rather than sequentially, reduces product development time and thereby maximizes economic returns. We believe 11 that CROs with global operations and experience in a broad range of therapeutic areas are a key resource to support a global regulatory approval strategy. Alongside this, the increasing need to access pools of “treatment naive” patients is leading to the conduct of clinical trials in new “emerging regions” such as Eastern Europe, Latin America, South America and India. We believe that having access to both traditional and emerging clinical research markets gives global CROs a competitive advantage. Emergence of the Biotechnology Sector The nature of the drugs being developed is changing. Biotechnology is enabling the development of targeted drugs with diagnostic tests to determine a priori whether a drug will be effective given a patient’s genomic profile. An increasing proportion of research and development (“R&D”) expenditure is being spent on the development of highly technical drugs to treat very specific therapeutic areas. Much of this discovery expertise is found in smaller biotechnology firms. We believe that it is to these organizations that the large pharmaceutical companies will look for an increasing proportion of their new drug pipelines. Whether it is through licensing agreements, joint ventures or equity investment, we believe we will see the emergence of more strategic relationships between small discovery firms and the larger pharmaceutical groups. As the majority of these biotechnology companies do not have a clinical development infrastructure, we believe that the services offered by CROs will continue to be in demand from such companies. Funding of Research and Development Activities of the Biotechnology Sector The emergence of the Biotechnology sector and the increasing number of highly technical drugs being developed by these companies has resulted in increased funding for research and development in recent years. Much of this funding was aimed at small biotechniology companies who do not derive revenues from the sale of other product lines and are dependent on external funding and investment to support their research activities. The current global downturn has reduced the availability of funding to support research and development activities which may reduce the number of treatments in Phase II-III clinical trials in future years. As many of these companies are dependent on the CRO industry to manage their trials the reduction in funding may impact demand for such activities. Cost Containment Pressures. Over the past several years, drug companies have sought more efficient ways of conducting business due to margin pressures stemming from patent expirations, greater acceptance of generic drugs, pricing pressures caused by the impact of managed care, purchasing alliances and regulatory consideration of the economic benefit of new drugs. Consequently, drug companies are centralizing research and development, streamlining their internal structures and outsourcing certain functions to CROs, thereby converting previously fixed costs to variable costs. The CRO industry, by specializing in clinical trials management, is often able to perform the needed services with greater focus and at a lower cost than the client could perform internally. Increasing Number of Large Long-Term Studies We believe that to establish competitive claims, to obtain reimbursement authorization from bodies such as the National Institute for Health and Clinical Excellence in the UK, and to encourage drug prescription by physicians in some large and competitive categories, more clients need to conduct outcome studies to demonstrate, for example, that mortality rates are reduced by certain drugs. To verify such outcomes, very large patient numbers are required and they must be monitored over long time periods. We believe that as these types of studies increase there will be a commensurate increase in demand for the services of CROs who have the ability to quickly assemble large patient populations, globally if necessary, and manage this complex process throughout its duration. A focus on long–term product safety In the wake of a number of high profile recalls of previously approved drugs, regulatory authorities, such as the FDA and EMEA, are increasingly demanding that sponsors make arrangements to track the long-term safety of their products. The clinical trial approval process can only detect major and common adverse side effects of drugs; less common but no less serious effects may only become apparent after many years of use. As a result, there is an increase in the number of 12 drugs given “conditional approvals” where further ‘post-approval’ studies are being mandated. In addition, prudent sponsors undertake similar studies to detect early warning signs of any potential problems with their products. Such studies may take the form of prospective long-term safety studies, simpler observational studies or registries where patients meeting specific criteria for disease or drug use are followed for long periods to detect any safety issues. CROs are well positioned to perform these studies on behalf of sponsors. Furthermore, a variety of healthcare databases containing medical and prescribing records can be “data mined” to collect patient data from very large populations in support of on-going safety and efficacy assessments. Again, this sort of data management and biostatistical activity is well performed by CROs. Increasing Regulatory Demands. We believe that regulatory agencies are becoming more demanding with regard to the data required to support new drug approvals and are seeking more evidence that new drugs are safer and more effective than existing products. As a result, the complexity of clinical trials and the size of regulatory submissions are driving the demand for services provided by CROs. The ICON Strategy ICON’s mission is to provide flexible, superior quality, global pharmaceutical development services, that enable clients to expedite development, reduce costs and establish the benefits of treatments that enhance people’s lives. We provide these development services to clients on a stand-alone basis or as part of an integrated “full service” solution. Our primary approach is to use dedicated teams to achieve optimum results. While we believe that this operating model differentiates us from our competition in the CRO industry and enables us to deliver high quality services to our clients, we do retain the operational flexibility to implement a range of resourcing models to suit client requirements. Our strategy is to continue to grow by penetrating further our existing client base and adding new clients within the Phase I-IV outsourced development services market; the aim being to ensure we will be considered by every company for every major Phase I – IV project. We intend to implement our strategy by continuing to deliver high quality services, by increasing our geographic presence, expanding the scale and range of our services and, where appropriate, cross selling these services into clients. As needed, we intend to supplement our internal growth with strategic acquisitions. • • • Continue to Deliver High Quality Services and Customer Satisfaction. ICON’s core competency is project management, built up over the last eighteen years managing complex projects and underpinned by comprehensive and consistent processes which conform to the ISO9001:2000 quality standard. We have extensive therapeutic and scientific knowledge residing in the organization and the capability to consistently solve the challenges that arise during clinical trials, each of which is the equivalent of a unique scientific study. We believe our quality processes, extensive experience, customer focus and flexibility allow us to provide consistent high quality, timely and cost effective services. We believe that the resulting customer satisfaction and enhanced reputation in the industry will continue to enable us to penetrate our existing client base and add new clients. Expand Geographic Presence. In a highly fragmented industry, we are one of a small group of organizations with the capability and expertise to conduct clinical trials on a global basis. We believe that this capability to provide our services globally in most major and developing pharmaceutical markets enhances our ability to compete for new business from large multinational pharmaceutical, biotechnology and medical device companies. We have expanded geographically through the establishment of 71 offices in 38 countries and intend to continue expanding in regions that have the potential to increase our client base or increase our investigator and patient populations. We have most recently been expanding our presence in Eastern Europe and Latin America as well as parts of Asia including India and Japan. Increase Scale and Range of Services. We seek to enhance our competitive position by increasing the scale and range of our services. We intend to expand our clinical trials, central laboratory, digital imaging, IVRS (interactive voice recognition system), data management, statistical and consulting operations in order to 13 capitalize further on the outsourcing opportunities currently available from our clients. The recent high profile withdrawal of several drugs from the market is also placing the spotlight on drug safety which will lead to greater emphasis, by all involved in drug development, on post-marketing safety monitoring. ICON’s acquisition of Healthcare Discoveries and Prevalere have increased our capability in the early phase of clinical development and will enable ICON to offer integrated Phase I/Bioanalytical services to clients. Cross Sell Services. By building up a full range of development services, ICON can support clients through all stages of their product lifecycle. There are signs that certain client segments are looking to rationalize their supply base down to a small number of CROs who can provide this breadth of service. A core part of our business development strategy is to “cross sell” ICON’s service portfolio. By developing and maintaining close relationships with clients, we gain repeat business and achieve lateral penetration of services with the client organization. Strategic acquisitions. Alongside organic growth, we will continue to seek strategic acquisitions that fall within and are complimentary to our existing service lines. • • Services ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies. Our core Clinical Research business specializes in the planning, management, execution and analysis of Phase I – IV clinical trials, ranging from small studies to complex, multinational projects. Specific clinical research services offered include: Investigator Recruitment Study Monitoring and Data Collection Case Report Form (“CRF”) Preparation Patient Safety Monitoring Clinical Data Management IVR (Interactive Voice Response) • • • • • • • Medical Reporting • Patient Registries • Outcomes Research • Health Economics • • • • • • • • • • Medical Imaging Contract Staffing • Bioanalysis Strategic Consulting Strategic Analysis and Data Operations Clinical Pharmacology Immunoassay development Pharmacokinetic and Pharmacodynamic analysis Study Protocol Preparation Regulatory Consulting Product Development Planning 14 An important element in monitoring patient safety during a clinical trial is the conduct of various laboratory tests on the patient’s blood, urine and other bodily fluids at appropriate intervals during the trial. The analysis of these samples must be standardized and the results must be promptly transmitted to the investigator. ICON Central Laboratories provides global central laboratory services dedicated exclusively to clinical trials. Specific services offered by ICON Central Laboratories include: Sample analyses • • Safety testing • Microbiology • • Custom flow cytometry Electronic transmission of test results Organizational Structure Name Country of incorporation Group ownership* Israel . . . . . . . . . . . . . . . . Spain ICON Clinical Research Limited . . . . . . . . . . . . . . . . . . . Republic of Ireland ICON Clinical Research Inc. . . . . . . . . . . . . . . . . . . . . . . USA Ovation Healthcare Research 2, Inc. . . . . . . . . . . . . . . . . . USA ICON Clinical Research (UK) Limited . . . . . . . . . . . . . . . . United Kingdom ICON Clinical Research GmbH . . . . . . . . . . . . . . . . . . . . Germany ICON Clinical Research SARL . . . . . . . . . . . . . . . . . . . . France ICON Clinical Research Israel Limited . . . . . . . . . . . . . . . ICON Clinical Research Espana S.L. ICON Clinical Research Kft . . . . . . . . . . . . . . . . . . . . . . Hungary ICON Clinical Research S.R.L. . . . . . . . . . . . . . . . . . . . . Romania ICON Clinical Research LLC . . . . . . . . . . . . . . . . . . . . . Ukraine ICON Holdings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Republic of Ireland ICON Holdings Clinical Research International Limited . . . . Republic of Ireland ICON Clinical Research S.R.O. . . . . . . . . . . . . . . . . . . . . Czech Republic ICON Clinical Research (Canada) Inc. . . . . . . . . . . . . . . . . Canada ICON Clinical Research Pty Limited . . . . . . . . . . . . . . . . . Australia ICON Clinical Research (New Zealand) Limited . . . . . . . . . New Zealand ICON Japan K.K. ICON Clinical Research Pte. Limited . . . . . . . . . . . . . . . . Singapore ICON Clinical Research Korea Yuhan Hoesa . . . . . . . . . . . . Korea ICON Clinical Research India Private Limited . . . . . . . . . . . India ICON Clinical Research S.A. ICON Pesquisas Clinicas LTDA . . . . . . . . . . . . . . . . . . . . Brazil ICON Clinical Research México, S.A. de C.V. . . . . . . . . . . Mexico ICON Chile Limitada . . . . . . . . . . . . . . . . . . . . . . . . . . . Chile ICON Clinical Research Peru SA . . . . . . . . . . . . . . . . . . . Peru ICON Clinical Research Sucursal Colombia . . . . . . . . . . . . Colombia ICON Development Solutions Limited . . . . . . . . . . . . . . . UK ICON Contracting Solutions, Inc. DOCS International BV . . . . . . . . . . . . . . . . . . . . . . . . . Netherlands ICON Development Solutions Inc. . . . . . . . . . . . . . . . . . . USA ICON Central Laboratories Inc. . . . . . . . . . . . . . . . . . . . . USA Beacon Bioscience, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . USA Healthcare Discoveries Inc . . . . . . . . . . . . . . . . . . . . . . . . USA Prevalere Life Sciences Inc . . . . . . . . . . . . . . . . . . . . . . . USA . . . . . . . . . . . . . . . . . . . . . Argentina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . USA Japan * All shareholdings comprise ordinary shares. 15 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% Information Systems Our information technology strategy is built around deploying IT systems to enable the delivery of our business services in a global environment. The focus is to provide ease of access to information for our staff and clients globally. Our current information systems are built on open standards and leading commercial business applications from vendors including Microsoft, Oracle, EMC, BEA, Phase Forward and Medidata. IT expenditure is authorized by strict IT Governance policies requiring senior level approval of all strategic IT expenditure. All critical business systems are formally delivered following a structured project management and systems delivery life cycle approach. Critical clinical information systems, which manage clinical data, are validated in accordance with FDA regulations and those of other equivalent regulatory bodies throughout the world. In Clinical Operations, we have deployed a suite of software applications that assist in the management and tracking of our clinical trials activities. These software applications are both internally developed and commercially available applications from leading vendors in the industry. These include a clinical trials management application that tracks all relevant data in a trial and automates all management and reporting processes. In our Data Management function, we have deployed leading clinical data management solutions including Electronic Data Capture (EDC) solutions from leading industry vendors. Our state of the art workflow technology allows us to process clinical trials data seamlessly throughout the Company. We have also developed an interactive voice response system to increase the efficiency of clinical trials. This system provides features such as centralized patient randomization, drug inventory management, patient diary collection and provides our clients with a fully flexible data retrieval solution which can be utilized via telephone, internet browser or a WAP enabled device. Recognizing that each client has its own requirements and systems, we seek to ensure an entirely flexible approach to client needs. An example of this flexibility is in the provision of portal solutions that allows clients access to study related information via a secure web based environment. We also provide secure remote access to client systems for clients who require us to utilize their internal platforms. ICON’s strategy of using technology to enhance our global processes can be seen in our deployment of a global SOP Document Management system and a WEB based training delivery solution. In our central laboratory, we utilize a comprehensive suite of software, including a laboratory information management system (LIMS), a kit/sample management system and a web interface system to allow clients to review results online. Our IT systems are operated from two centralized hubs in Philadelphia and Dublin. Other offices are linked to these hubs through a resilient network that is managed by a tier one global telecommunications provider. Traveling staff can also access all systems via secure remote dial up facilities. A global corporate intranet portal provides access to all authorized data and applications for our internal staff as well as providing an internal platform for company wide communication. Sales and Marketing Our global sales and marketing strategy is to focus our business development efforts on pharmaceutical, biotechnology and medical device companies whose development projects are advancing. By developing and maintaining close relationships with our clients, we gain repeat business, can leverage a full service portfolio and achieve lateral penetration into other therapeutic divisions where applicable. Simultaneously, we are actively establishing new client relationships. While our sales and marketing activities are carried out locally by executives in each of the major locations, the sales and marketing process is coordinated centrally to ensure a consistent and differentiated market positioning for ICON and ongoing development of the ICON brand. In addition, all our business development professionals, senior executives and project team leaders share responsibility for the maintenance of key client relationships and business development activities. Clients In the year ended December 31, 2008, revenue was earned from over 400 clients, including all of the top 20 pharmaceutical companies as ranked by 2007 revenues. 16 We have in the past and may in the future derive a significant portion of our net revenue from a relatively limited number of major projects or clients. During the year ended December 31, 2008, 29% of our net revenue was derived from our top five clients and no one client contributed more than 10% of net revenues. During the year ended December 31, 2007, 30% of our net revenue was derived from our top five clients and no one client contributed more than 10% of net revenues. During the year ended December 31, 2006, 35% of our net revenue was derived from our top five clients and no one client contributed more than 10% of net revenues. We believe that the importance of certain clients reflects our success in penetrating our client base. The loss of, or a significant decrease in business from one or more of these key clients could result in a material adverse effect. Contractual Arrangements We are generally awarded contracts based upon our response to requests for proposals received from pharmaceutical, biotechnology and medical device industries. Most of our revenues are earned from contracts which are fixed price, based on certain activities and performance specifications. Payment terms usually provide either for payments based on the achievement of certain identified milestones or activity levels or monthly payments according to a fixed payment schedule over the life of the contract. Where clients request changes in the scope of a trial or in the services to be provided by us, a change order or amendment is issued often resulting in additional revenues for us. We also contract on a “fee-for-service,” or “time and materials” basis, but this accounts for a small portion of overall project activities. Contract terms may range from several weeks to several years depending on the nature of the work to be performed. In most cases, a portion of the contract fee, typically 10% to 20%, is paid at the time the study or trial is started. The balance of the contract fee payable is generally payable in installments over the study or trial duration and may be based on the achievement of certain performance targets or “milestones” or, to a lesser extent, on a fixed monthly payment schedule. For instance, installment payments may be based on patient enrollment or delivery of the database. Reimbursable expenses are typically estimated and budgeted within the contract and invoiced on a monthly basis. Reimbursable expenses include payments to investigators, travel and accommodation costs and various other direct costs incurred in the course of the clinical trial which are fully reimbursable by the client. Most of our contracts are terminable immediately by the client with justifiable cause or with 30 to 90 days notice without cause. In the event of termination, we are entitled to all sums owed for work performed through the notice of termination and certain costs associated with termination of the study. Termination or delay in the performance of a contract occurs for various reasons, including, but not limited to, unexpected or undesired results, production problems resulting in shortages of the drug, adverse patient reactions to the drug, the client’s decision to de-emphasize a particular trial or inadequate patient enrollment or investigator recruitment. Backlog Our backlog consists of potential net revenue yet to be earned from projects awarded by clients. At December 31, 2008, we had a backlog of approximately $1.7 billion, compared with approximately $1.3 billion at December 31, 2007. We believe that our backlog as of any date is not necessarily a meaningful predictor of future results, due to the potential for cancellation or delay of the projects underlying the backlog, and no assurances can be given that we will be able to realize this backlog as net revenue. Competition The CRO industry is highly fragmented, consisting of several hundred small, limited-service providers and a limited number of medium-sized and large CROs with global operations. We primarily compete against in-house departments of pharmaceutical companies and other CROs with global operations. Some of these competitors have substantially greater capital, technical and other resources than us. CROs generally compete on the basis of previous experience, the quality of contract research, the ability to organize and manage large-scale trials on a global basis, the ability to manage large and complex medical databases, the ability to provide statistical and regulatory services, the ability to recruit suitable investigators, the ability to integrate information technology with systems to improve the efficiency of contract research, an international presence with strategically located facilities, financial viability, medical 17 and scientific expertise in specific therapeutic areas and price. We believe that we compete favorably in these areas. Our principal CRO competitors are Covance Inc., i3 Research (United Health Group Incorporated), Kendle International Inc., MDS Inc., Omnicare Inc., PAREXEL International Corporation, Pharmaceutical Product Development Inc., PharmaNet Development Group Inc., PRA International Inc. and Quintiles Transnational Corporation. The trend toward CRO industry consolidation has resulted in heightened competition among the larger CROs for clients and acquisition candidates. Government Regulation Regulation of Clinical Trials The clinical investigation of new drugs is highly regulated by government agencies. The standard for the conduct of clinical research and development studies is Good Clinical Practice, which stipulates procedures designed to ensure the quality and integrity of data obtained from clinical testing and to protect the rights and safety of clinical subjects. Regulatory authorities, including the FDA, have promulgated regulations and guidelines that pertain to applications to initiate trials of products, the approval and conduct of studies, report and record retention, informed consent, applications for the approval of drugs and post-marketing requirements. Pursuant to these regulations and guidelines, service providers that assume the obligations of a drug sponsor are required to comply with applicable regulations and are subject to regulatory action for failure to comply with such regulations and guidelines. In the United States and Europe, the trend has been in the direction of increased regulation by the applicable regulatory authority. In providing our services in the United States, we are obligated to comply with FDA requirements governing such activities. These include ensuring that the study is approved by an appropriate independent review board (IRB)/Ethics Committee, obtaining patient informed consents, verifying qualifications of investigators, reporting patients’ adverse reactions to drugs and maintaining thorough and accurate records. We must maintain critical documents for each study for specified periods, and such documents may be reviewed by the study sponsor and the FDA during audits. The services we provide outside the United States are ultimately subject to similar regulation by the relevant regulatory authority, including the Medicines Control Agency in the United Kingdom and the Bundesinstitut für Arzneimittel und Medizinprodukte in Germany. In addition, our activities in Europe are affected by the European Medicines Evaluation Agency, which is based in London, England. We must retain records for each study for specified periods for inspection by the client and by the applicable regulatory authority during audits. If such audits document that we have failed to comply adequately with applicable regulations and guidelines, it could result in a material adverse effect. In addition, our failure to comply with applicable regulation and guidelines, depending on the extent of the failure, could result in fines, debarment, termination or suspension of ongoing research or the disqualification of data, any of which could also result in a material adverse effect. Potential Liability and Insurance We contract with physicians who serve as investigators in conducting clinical trials to test new drugs on their patients. Such testing creates a risk of liability for personal injury to or death of the patients resulting from adverse reactions to the drugs administered. In addition, although we do not believe that we are legally accountable for the medical care rendered by third party investigators, it is possible that we could be subject to claims and expenses arising from any professional malpractice of the investigators with whom we contract. We also could be held liable for errors or omissions in connection with the services we perform. From time to time, we are asked to act as the legal representative of a client in certain jurisdictions where the client does not itself have a legal entity but where legislation requires it to do so. As we believe that acting as legal representative of clients might expose us to a higher risk of liability, there is an entity within the ICON Group designated to provide this service in relevant jurisdictions subject to certain preconditions being met. The preconditions relate to obtaining protections such as specific insurance and indemnities from the client to cover the nature of the exposure. We believe that the risk of liability to patients in clinical trials is mitigated by various regulatory requirements, including the role of institutional review boards and the need to obtain each patient’s informed consent. The FDA requires each human clinical trial to be reviewed and approved by the institutional review board at each study site. An 18 institutional review board is an independent committee that includes both medical and non-medical personnel and is obligated to protect the interests of patients enrolled in the trial. After the trial begins, the institutional review board monitors the protocol and measures designed to protect patients, such as the requirement to obtain informed consent. We further attempt to reduce our risks through contractual indemnification provisions with clients and through insurance maintained by clients, investigators and us. However, the contractual indemnifications generally do not protect us against certain of our own actions such as negligence, the terms and scope of such indemnification vary from client to client and from trial to trial, and the financial performance of these indemnities is not secured. Therefore, we bear the risk that the indemnity may not be sufficient or that the indemnifying party may not have the financial ability to fulfill its indemnification obligations. We maintain worldwide professional liability insurance. We believe that our insurance coverage is adequate. There can be no assurance, however, that we will be able to maintain such insurance coverage on terms acceptable to us, if at all. We could be materially adversely affected if we were required to pay damages or bear the costs of defending any claim outside the scope of or in excess of a contractual indemnification provision or beyond the level of insurance coverage or in the event that an indemnifying party does not fulfill its indemnification obligations. Description of Property We lease all but one of our facilities under operating leases. Our principal executive offices are located in South County Business Park, Leopardstown, Dublin, Republic of Ireland, where we own an office facility on approximately four and a half acres. In July 2008 we completed an expansion of this facility, extending the facility by approximately 12,900 square meters to approximately 15,800 square meters. We maintain three offices in New York, two offices in each of the following US cities: Philadelphia, Chicago, San Antonio and San Francisco, and one office in each of the following US cities: Irvine, Nashville, Wilmington, Raleigh, Baltimore, Tampa, San Diego, Salt Lake City and Houston. Our European operations maintain two offices in Manchester, Paris, Amsterdam, Stockholm and Warsaw, and one office in each of the following cities: Southampton, Cambridge, Marlow, Frankfurt, Munich, Berlin, Helsinki, Copenhagen, Milan, Barcelona, Riga, Budapest, Vilinius, Prague, Kiev, Bucharest, Moscow, Novosibirsk and Tel Aviv. Our Rest of World offices are located in Auckland, Sydney, Tokyo, Osaka, Seoul, Beijing, Taipei, Hong Kong, Bangkok, Singapore, Chennai, Bangalore, New Dehli, Johannesburg, Montreal, Mexico City, Sao Paolo, Lima, Buenos Aires, Bogota and Santiago. Unresolved Staff Comments Not applicable. Item 5. Operating and Financial Review and Prospects The following discussion and analysis should be read in conjunction with our Consolidated Financial Statements, accompanying notes and other financial information, appearing in Item 18. The Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States. Overview We are a contract research organization (“CRO”), providing outsourced development services on a global basis to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies. We have the operational flexibility to provide development services on a stand-alone basis or as part of an integrated “full service” solution. Our preferred approach is to use dedicated teams to achieve optimum results, but we can implement a range of resourcing models to suit client requirements, and increasingly our teams are flexibly applied to minimize costs for our clients. 19 In a highly fragmented industry, we are one of a small number of companies with the capability and expertise to conduct clinical trials in all major therapeutic areas on a global basis. Currently, we have 6,975 employees, in 71 locations in 38 countries, providing Phase I - IV Clinical Trial Management, Drug Development Support Services, Data Management and Biostatistics and Central Laboratory and Imaging Services. For the year ended December 31, 2008, we derived approximately 43.8%, 47.8% and 8.4% of our net revenue in the United States, Europe and Rest of World, respectively. Revenue consists primarily of fees earned under contracts with third-party clients. In most cases, a portion of the contract fee is paid at the time the study or trial is started, with the balance of the contract fee generally payable in installments over the study or trial duration, based on the achievement of certain performance targets or “milestones”. Revenue for contracts is recognized on a proportional performance method based on the relationship between time incurred and the total estimated duration of the trial or on a fee-for-service basis according to the particular circumstances of the contract. As is customary in the CRO industry, we contract with third party investigators in connection with clinical trials. All investigator fees and certain other costs, where reimbursed by clients, are, in accordance with industry practice, deducted from gross revenue to arrive at net revenue. As these costs vary from contract to contract, we view net revenue as our primary measure of revenue growth. Direct costs consist primarily of compensation, associated fringe benefits and share based compensation expense for project-related employees and other direct project driven costs. Selling, general and administrative expenses consist of compensation, related fringe benefits and share based compensation expense for selling and administrative employees, professional services, advertising costs and all costs related to facilities and information systems. Our backlog consists of potential net revenue yet to be earned from projects awarded by clients. At December 31, 2008, we had a backlog of approximately $1.7 billion, compared with approximately $1.3 billion at December 31, 2007. We believe that our backlog as of any date is not necessarily a meaningful predictor of future results, due to the potential for cancellation or delay of the projects underlying the backlog, and no assurances can be given that we will be able to realize this backlog as net revenue. As the nature of ICON’s business involves the management of projects having a typical duration of one to three years, the commencement or completion of projects in a fiscal year can have a material impact on revenues earned with the relevant clients in such years. In addition, as we typically work with some, but not all, divisions of a client, fluctuations in the number and status of available projects within such divisions can also have a material impact on revenues earned from such clients from year to year. Although we are domiciled in Ireland, we report our results in U.S. dollars. As a consequence the results of our non-U.S. based operations, when translated into U.S. dollars, could be materially affected by fluctuations in exchange rates between the U.S. dollar and the currencies of those operations. In addition to translation exposures, we are also subject to transaction exposures because the currency in which contracts are priced can be different from the currencies in which costs relating to those contracts are incurred. We have 20 operations operating in U.S. dollars, 11 trading in Euros, 5 in pounds Sterling, 3 in Indian Rupee, 2 each in Russian Rouble, Japanese Yen, Swedish Krona and Polish Zloty, and 1 each in Australian dollars, Singapore dollars, Israeli New Shekels, Latvian Lats, Argentine Peso, South African Rand, Canadian dollar, Hungarian Forint, Danish Krone, Czech Koruna, Ukraine Hryvnia, Romanian New Leu, Hong Kong dollar, Taiwan dollar, Mexican Peso, Brazilian Real, Chilean Peso, South Korean Won, Thai Baht, Chinese Yuan Renminbi, Lithuanian Litas, Colombian Peso, Peruvian Neuvo Sol & New Zealand dollars. Our operations in the United States are not materially exposed to such currency differences as the majority of our revenues and costs are in U.S. dollars. However, outside the United States the multinational nature of our activities means that contracts are usually priced in a single currency, most often U.S. dollars, Euros or pounds Sterling, while costs arise in a number of currencies, depending, among other things, on which of our offices provide staff for the contract, and the location of investigator sites. Although many such contracts benefit from some degree of natural hedging due to the matching of contract revenues and costs in the same currency, where costs are incurred in currencies other than those in which contracts are priced, fluctuations in the relative value of those currencies could have a material effect on ICON’s results of operations. We regularly review our currency exposures and, when appropriate, hedge a portion of these, using forward exchange contracts, where they are not covered by natural hedges. In addition, we usually negotiate currency fluctuation clauses in our contracts which allow for price negotiation if changes in the relative value of those currencies exceed predetermined tolerances. 20 As we conduct operations on a global basis, our effective tax rate has depended and will depend on the geographic distribution of our revenue and earnings among locations with varying tax rates. ICON’s results of operations therefore may be affected by changes in the tax rates of the various jurisdictions. In particular, as the geographic mix of our results of operations among various tax jurisdictions changes, our effective tax rate may vary significantly from period to period. Operating Results The following table sets forth for the periods indicated certain financial data as a percentage of net revenue and the percentage change in these items compared to the prior comparable period. The trends illustrated in the following table may not be indicative of future results. Jan 1, 2007 to Dec 31, 2007 Jan 1, 2008 to Dec 31, 2008 Jan 1, 2007 to Dec 31, 2007 Jan 1, 2008 to Dec 31, 2008 Percentage of Net Revenue Percentage Increase Net revenue . . . . . . . . . . . . . . . . . . . . . . . . Costs and expenses: Direct costs . . . . . . . . . . . . . . . . . . . . . . . . Selling, general and administrative . . . . . . . . . Depreciation and amortization . . . . . . . . . . . . Income from operations . . . . . . . . . . . . . . . . 100% 56.2% 29.8% 3.0% 11.0% 100% 56.5% 28.8% 3.2% 11.5% 38.4% 37.2% 38.3% 37.6% 27.2% 44.8% 38.0% 32.3% 45.9% 43.7% Year ended December 31, 2008 compared to year ended December 31, 2007 Net revenue for the year increased by $234.5 million, or 37.2%, from $630.7 million for the year ended December 31, 2007 to $865.2 million for the year ended December 31, 2008. Revenues in the United States, Europe and the Rest of World increased by 20.0%, 48.3%, and 102.2% respectively. In the year ended December 31, 2008, net revenue from our central laboratory business increased by 32.9%, from $53.5 million, to $71.1 million, while our clinical research segment improved by 37.6%, from $577.2 million to $794.1 million. This increase has resulted from a combination of increased business from existing clients, business won from new clients and increased use of outsourcing by the pharmaceutical, biotechnology and medical device industries. Direct costs for the year increased by $134.8 million, or 38.0%, from $354.5 million for the year ended December 31, 2007 to $489.2 million for the year ended December 31, 2008. Direct costs as a percentage of net revenue increased to 56.5% in the year ended December 31, 2008, compared to 56.2% in the year ended December 31, 2007. The primary reason for this increase was an increase in personnel related costs of $120.7 million resulting from an increase in the number of project related employees of over 990. The remainder of the increase resulted primarily from increased laboratory and consulting expenses. Selling, general and administrative expenses for the year increased by $60.8 million, or 32.3%, from $188.0 million for the year ended December 31, 2007, to $248.8 million for the year ended December 31, 2008. As a percentage of net revenue, selling, general and administrative expenses, decreased from 29.8% for the year ended December 31, 2007, to 28.8% for the year ended December 31, 2008. The increase in absolute terms is primarily driven by increased personnel costs of $34.5 million, principally driven by increased levels of both administrative and operations infrastructure staff to support expanding operations and revenue growth. In addition to these personnel costs there were additional rental charges of $7.5 million, from further office openings in 2008, increased professional, legal and accounting costs of $5.4 million, increased utility costs of $5.5 million and an increase of $4.3 million in relation to support and maintenance costs. These increases were partially offset by a gain in relation to realized and unrealized foreign exchange of $2.3 million which compared with a loss of $6.3 million for the year ended December 31, 2007. These gains arise on the revaluation of monetary assets and liabilities throughout the year. Total share based compensation expense recognized during the year ended December 31, 2008, amounted to $6.1 milllion compared to $5.7 million during the year ended December 31, 2007. Depreciation and amortization expense for the year increased by $8.7 million, or 45.9%, from $19.0 million for the year ended December 31, 2007, to $27.7 million for the year ended December 31, 2008. As a percentage of net revenue, depreciation and amortization increased from 3.0% of net revenues for the year ended December 31, 2007, to 21 3.2% for the year ended December 31, 2008. This increase relates primarily to our investment in facilities and equipment to enable our continued growth. Capital expenditures were $71.4 million in 2008. $24.6 million of this spend is attributable to expenditure on the expansion of our facility in Dublin, Republic of Ireland, while the balance relates to the Company’s continued investment in facilities and information technology to support our continued growth globally. We expect depreciation in 2009 to increase as a result of this investment. Income from operations for the year increased by $30.3 million, or 43.7%, from $69.2 million for the year ended December 31, 2007 to $99.5 million for the year ended December 31, 2008. As a percentage of net revenue, income from operations increased from 11.0% of net revenues for the year ended December 31, 2007, to 11.5% for the year ended December 31, 2008. Operating margins for our central laboratory business were 7.8% for the year ended December 31, 2008, compared to 6.9% for the year ended December 31, 2007. The central laboratory constitutes approximately 8.2% of our business revenues for the year ended December 31, 2008. Operating margins for our clinical research segment increased to 11.8% for the year ended December 31, 2008, from 11.4% for the year ended December 31, 2007. Net interest expense for the year ended December 31, 2008, was $1.2 million, compared with net interest income of $2.7 million for the year ended December 31, 2007. The Company has entered into a number of significant banking facilities since July 2007. These facilities have been used to fund the acquisitions of DOCS International in July 2007, Healthcare Discoveries in February 2008 and Prevalere in November 2008, and also to fund the expansion of the Company’s Dublin facility. Our provision for income taxes increased from $15.8 million for the year ended December 31, 2007, to $20.0 million for the year ended December 31, 2008. ICON plc’s effective tax rate for the year ended December 31, 2008, was 20.3% compared with 22.0% for the year ended December 31, 2007. The effective tax rate is principally a function of the distribution of pre-tax profits in the territories in which the Group operates. Year ended December 31, 2007 compared to year ended December 31, 2006 Net revenue increased by $175.1 million, or 38.4%, from $455.6 million to $630.7 million. Revenues in the United States, Europe and the Rest of World increased by 18.7%, 71.2% and 35.0% respectively. In the year ended December 31, 2007, net revenue from our central laboratory business increased by 13.3%, from $47.2 million, to $53.5 million, while our clinical research segment improved by 41.3%, from $408.4 million to $577.2 million, over the prior period. This increase in net revenue has resulted from a combination of increased business from existing clients, business won from new clients, increased use of outsourcing by the pharmaceutical, biotechnology and medical device industries and an underlying increase in research and development spending. Direct costs increased by $98.2 million, or 38.3%, from $256.3 million to $354.5 million. Direct costs as a percentage of net revenue remained static at 56.2% in the year ended December 31, 2007, compared to the year ended December 31, 2006. The primary reason for the increase in direct costs was the increase in personnel related costs of $86.3 million resulting from the increase in direct headcount of over 1,100 employees. The remainder of the increase resulted primarily from increased laboratory and consulting expenses. Selling, general and administrative expenses increased by $51.4 million, or 37.6%, from $136.6 million to $188.0 million. As a percentage of net revenue, selling, general and administrative expenses, decreased from 30.0% for the year ended December 31, 2006, to 29.8% for the year ended December 31, 2007. The increase in SG&A costs is primarily driven by increased personnel costs of $22.0 million principally driven by the increased levels of both administrative and operations infrastructure staff to support expanding operations and revenue growth. In addition to these personnel costs there were additional rental charges of $4.9 million from further office openings in 2007, increased professional, legal and accounting costs of $4.5 million, increased information technology costs of $3.8 million, an increase of $4.7 million in relation to realized and unrealized foreign exchange loss and increased temporary staff and recruitment costs of $6.6 million. The total share based compensation expense recognized during the year ended December 31, 2007 amounted to $5.7m compared to $4.1 million during the year ended December 31, 2006. Depreciation and amortization expense increased by $4.1 million, or 27.2%, from $14.9 million to $19.0 million. As a percentage of net revenue, depreciation and amortization decreased from 3.3% of net revenues for the year ended December 31, 2006, to 3.0% for the year ended December 31, 2007. This increase in absolute terms relates primarily to 22 our investment in facilities and equipment to enable our continued growth. Capital expenditures were $75.7 million in 2007. $37.9 million of this spend is attributable to the construction of the Company’s new headquarter building in Dublin, Republic of Ireland, while the balance relates to the Company’s continued investment in facilities and information technology to support its continued growth globally. We expect depreciation in 2008 to increase as a result of this investment. Income from operations increased by $21.4 million, or 44.8%, from $47.8 million to $69.2 million. As a percentage of net revenue, income from operations increased from 10.5% of net revenues for the year ended December 31, 2006, to 11% for the year ended December 31, 2007. The year ended December 31, 2007, saw a continued improvement in the performance of the central laboratory business, with results improving from an operating profit of 4.9% for the year ended December 31, 2006, to an operating profit of 6.9% for the year ended December 31, 2007. The central laboratory constitutes approximately 8.5% of our business revenues for the year ended December 31, 2007. Operating margins for our clinical research segment increased to 11.4% in the year ended December 31, 2007, from 11.1% for the year ended December 31, 2006. Net interest income for the year ended December 31, 2007, was $2.7 million, a decrease of $0.9 million from the year ended December 31, 2006. The Company entered into two significant banking facilities during 2007 to fund the acquisition of DOCS International in July 2007 $40.6 million (A€ 29.5 million) and expenditure on the expansion of the Company’s facility. Our provision for income taxes increased from $12.9 million for the year ended December 31, 2006, to $15.8 million for the year ended December 31, 2007. ICON plc’s effective tax rate for the year ended December 31, 2007, was 22% compared with 25% for the year ended December 31, 2006. The effective tax rate is principally a function of the distribution of pre-tax profits in the territories in which the Group operates. Liquidity and Capital Resources The CRO industry generally is not capital intensive. Since our inception, we have financed our operations and growth primarily with cash flows from operations, net proceeds of $49.1 million raised in our initial public offering in May 1998, net proceeds of $44.3 million raised in our public offering in August 2003 and net borrowings of $105.4 million. Our principal operating cash needs are payment of salaries, office rents, travel expenditures and payments to investigators. The aggregate amount of employee compensation, excluding stock compensation expense, paid by us and our subsidiaries for the years ended December 31, 2006, December 31, 2007 and December 31, 2008, amounted to $274.6 million, $382.7 million and $528.5 million respectively. Investing activities primarily reflect capital expenditures for facilities, information systems enhancements, the purchase of short-term investments and acquisitions. Our clinical research and development contracts are generally fixed price with some variable components and range in duration from a few weeks to several years. Revenue from contracts is generally recognized as income on the basis of the relationship between time incurred and the total estimated contract duration or on a fee-for-service basis. The cash flow from contracts typically consists of a down payment of between 10% and 20% paid at the time the contract is entered into, with the balance paid in installments over the contract’s duration, in some cases on the achievement of certain milestones. Accordingly, cash receipts do not correspond to costs incurred and revenue recognized on contracts. As of December 31, 2008, our working capital was $186.0 million, compared to $193.3 million at December 31, 2007. The most significant influence on our operating cash flow is revenue outstanding, which comprises accounts receivable and unbilled revenue, less payments on account. The dollar values of these amounts and the related days revenue outstanding can vary due to the achievement of contractual milestones and the timing of cash receipts. The number of days revenue outstanding was 70 days at December 31, 2008 and 66 days at December 31, 2007. Net cash provided by operating activities was $81.3 million for the year ended December 31, 2008, compared with $43.0 million for the year ended December 31, 2007 and $50.5 million for the year ended December 31, 2006. The increase in cash provided from operating activities arises primarily from an increase in the profits of the Company during the current year. Net cash used in investing activities was $117.4 million for the year ended December 31, 2008, compared with $118.5 million for the year ended December 31, 2007 and $55.3 million in the year ended December 31, 2006. Net cash 23 used in the year ended December 31, 2008 arises principally from capital expenditure and the purchase of subsidiary undertakings. Capital expenditure for the year ended December 31, 2008, amounted to $67.9 million, and included expenditure on the expansion of the Company’s facility in Dublin, Republic of Ireland, together with continued investment in global infrastructure and information technology systems to support ongoing expansion. Cash paid for the purchase of subsidiary undertakings during the year ended December 31, 2008, amounted to $49.5 million, and included the acquisitions of Healthcare Discoveries in February 2008 and Prevalere Life Sciences in November 2008. Net cash provided by financing activities was $22.3 million for the year ended December 31, 2008, compared with $94.0 million for the year ended December 31, 2007 and $7.7 million in the year ended December 31, 2006. We received an additional $10.0 million in net borrowings during the year ended December 31, 2008, $8.5 million on the exercise of share options and $4.1 million in income tax benefits from the exercise of share options. During the year ended December 31, 2007, we received $89.8 million in net borrowings, $5.3 million from the exercise of share options and $1.5 million in income tax benefits from the exercise of share options. As a result of these cash flows, cash and cash equivalents at December 31, 2008, was $58.4 million, a decrease of $18.5 million for the year ended December 31, 2008, compared to an increase of $13.8 million for the year ended December 31, 2007, and an increase of $3.5 million for the year ended December 31, 2006. Net debt at December 31, 2008, amounted to $4.3 million, comprising cash and cash equivalents of $58.4 million, short term investments of $42.7 million, less bank credit lines and loan facilities of $105.4 million. Net cash at December 31, 2007, amounted to $23.8 million, comprising cash and cash equivalents of $76.9 million, short term investments of $41.6 million, less bank credit lines and facilities of $94.8 million. On July 9, 2007, ICON plc entered into a five year committed multi-currency facility agreement for A€ 35 million ($48.9 million) with The Governor and Company of the Bank of Ireland. Our obligations under the facility are secured by certain composite guarantees, indemnities and pledges in favor of the bank. The facility bears interest at an annual rate equal to the EURIBOR plus a margin. On July 10, 2007, the Company drew down A€ 29.5 million ($41.2 million) of the facility to fund the acquisition of DOCS International. On October 15, 2007, the remaining A€ 5.5 million ($7.7 million) of the facility was drawn down to fund expenditure on the expansion of the Company’s facility in Dublin, Republic of Ireland. On January 2, 2009, an additional four year committed credit facility was negotiated with The Governor and Company of the Bank of Ireland for $25 million. The facility bears interest at LIBOR plus a margin and is secured by certain composite guarantees, indemnities and pledges in favour of the bank. On October 17, 2007, an uncommitted credit facility was negotiated with Allied Irish Bank plc, for A€ 30 million ($41.9 million). Interest is calculated at the EUR interbank rate plus a margin. The facility is secured by the same composite guarantees and indemnities in place for the Bank of Ireland committed facility. The funds were used to refinance overdraft facilities in place to fund expenditure on the expansion of the Dublin facility. On January 8, 2008, the facility with Allied Irish Banks plc was increased to A€ 50 million ($69.9 million). On December 22, 2008, committed credit facilities were negotiated with Allied Irish Bank plc for $75 million. The facilities comprise a one year Euro facility of approximately A€ 20 million ($28.0 million), with the balance comprising a three year US dollar facility. The Euro facility bears interest at EURIBOR plus a margin and the US dollar facility bears interest at LIBOR plus a margin. Both facilities are secured by certain composite guarantees and pledges in favour of the bank. These facilities replace the uncommitted facilities negotiated on January 8, 2008. $28.4 million of these facilities were used to fund the acquisition of Prevalere with the remaining balance used to refinance the previous drawn uncommitted facilities. On February 4, 2008, an uncommitted credit facility was negotiated with Citibank N.A, for $30 million. Interest is calculated at the London Interbank Market rate plus a margin. $12.0 million of this facility was drawn down in February 2008 to fund the acquisition of Healthcare Discoveries. On September 30, 2008, the $12.0 million previously drawn was repaid in full. At December 31, 2008, this facility remained un-drawn and available to the Company. The average margin payable on the above mentioned facilities is 1.70 percent. On February 11, 2008, the Company acquired 100% of the common stock of Healthcare Discoveries Inc., for an initial cash consideration of $10.9 million, excluding costs of acquisition. Healthcare Discoveries, located in San Antonio, Texas, is engaged in the provision of Phase I clinical trial management services. Certain performance 24 milestones were built into the acquisition agreement requiring payment of additional consideration of up to $10.0 million if these milestones were achieved during the year ended December 31, 2008. No amounts have been accrued at December 31, 2008, as the milestones have not been achieved. On November 14, 2008, the Company acquired 100% of the common stock of Prevalere Life Sciences Inc. (“Prevalere”), for an initial cash consideration of $36.8 million, excluding costs of acquisition. Prevalere, located in Whitesboro, New York, is a leading provider of bioanalytical and immunoassay services to pharmaceutical and biotechnology companies. Certain performance milestones were built into the acquisition agreement requiring potential additional consideration of up to $8.2 million if these milestones are achieved during the years ended December 31, 2008 and 2009. Additional consideration of $5.0 million has been accrued at December 31, 2008, in respect of the milestones for the year ended December 31, 2008. No amounts have been accrued for additional consideration potentially payable in respect of the milestones for the year ended December 31, 2009. On July 1, 2004, the Company acquired 70% of the common stock of Beacon Biosciences Inc. (“Beacon”), a leading specialist CRO, which provides a range of medical imaging services to the pharmaceutical, biotechnology and medical device industries, for an initial cash consideration of $9.9 million, excluding costs of acquisition. On December 31, 2008, the remaining 30% of the common stock was acquired by the Company for $17.4 million, excluding costs of acquisition. Certain performance milestones were built into the acquisition agreement for the remaining 30% of Beacon requiring potential additional consideration of up $3.0 million if these milestones are achieved during the year ended December 31, 2009. At December 31, 2008, no amounts have been accrued in respect of the potential additional consideration. On July 12, 2007, the Company acquired 100% of the common stock of DOCS International, a European based clinical research staffing organization, for a cash consideration of $40.6 million (A€ 29.5 million). DOCS International operates in eight European countries and focuses on the training and supply of contract and permanent clinical research personnel to the pharmaceutical and biotech industry. As at December 31, 2008, the Company had $285.8 million in contractual obligations and commercial commitments. As at December 31, 2008, the Company had known obligations of $168.6 million in respect of operating leases, primarily relating to leased office facilities. Additionally, the Company had bank debt of $105.4 million used to finance the acquisition of DOCS International in July 2007, Healthcare Discoveries in February 2008, Prevalere in November 2008, and expenditure on the expansion of our Dublin facility. Contractual obligations table The following table represents our contractual obligations and commercial commitments as of December 31, 2008: Operating lease obligations . . . . . . . . . Capital lease obligations . . . . . . . . . . Bank credit lines and loans facilities . . . Non-current tax liabilities . . . . . . . . . Less than 1 year Payments due by period 1 to 3 years (U.S.$ in millions) 38.2 0.3 40.2 — 60.5 0.4 53.0 8.0 Total 168.6 0.7 105.4 11.1 3 to 5 years More than 5 years 40.2 — 12.2 3.1 29.7 — — — Total (U.S.$ in millions) . . . . . . . . . $ 285.8 $ 78.7 $ 121.9 $ 55.5 $ 29.7 We expect to spend approximately $50 million in the next twelve months on further investments in information technology, the expansion of existing facilities and the addition of new offices. We expect to increase this level of spending in subsequent years. We believe that we will be able to fund our additional foreseeable cash needs for the next twelve months from cash flow from operations and existing cash balances. In the future, we may consider acquiring businesses to enhance our service offerings and global presence. Any such acquisitions could require additional external financing and we may from time to time seek to obtain funds from public or private issues of equity or debt securities. There can be no assurance that such financing will be available on terms acceptable to us. 25 Critical Accounting Policies The preparation of consolidated financial statements in accordance with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reported period. We base our estimates and judgments on historical experience and on the other factors that we believe are reasonable under current circumstances. Actual results may differ from these estimates if these assumptions prove to be incorrect or if conditions develop other than as assumed for the purposes of such estimates. The following is a discussion of the accounting policies used by us, which we believe are critical in that they require estimates and judgments by management. Revenue Recognition Significant management judgments and estimates must be made and used in connection with the recognition of revenue in any accounting period. Material differences in the amount of revenue in any given period may result if these judgments or estimates prove to be incorrect or if management’s estimates change on the basis of development of the business or market conditions. To date there have been no material differences arising from these judgments and estimates. We earn revenues by providing a number of different services to our clients. These services include clinical trials management, biometric activities, consulting, and imaging and laboratory services. Revenue for services, as rendered, are recognized only after persuasive evidence of an arrangement exists, the sales price is fixed or determinable and collectibility is reasonably assured. We recognize biometric revenues on a fee-for-service basis as each unit of data is prepared. Imaging revenue is recognized on a fee-for-service basis recognizing revenue for each image completed. Consulting revenue is recognized on a fee-for-service- basis recognizing revenue as each hour of the related service is performed. We recognize laboratory service revenue on a fee-for-service basis. We account for laboratory service contracts as multiple element arrangements, with contractual elements comprising laboratory kits and laboratory testing, each of which can be sold separately. Fair values for contractual elements are determined by reference to objective and reliable evidence of the fair values. Revenues for contractual elements are recognized on the basis of the number of deliverable units completed in the period. We recognize Clinical trials management revenue on a proportional performance method based on the relationship between hours incurred and the total estimated hours of the trial. We use the input (effort expended) method to measure progress towards completion as there is a direct relationship between input and productivity. Contract costs equate to the product of labor hours incurred and compensation rates. Contract revenue is the product of the aggregated labor hours required to complete the specified contract tasks at the agreed contract rates. We invoice our customers upon achievement of specified contractual milestones. This mechanism, which allows us to receive payment from our customers throughout the duration of the contract, is not reflective of revenue earned. We recognize revenues over the period from the awarding of the customer’s contract to study completion and acceptance. This requires us to estimate total expected revenue, time inputs, contract costs, profitability and expected duration of the clinical trial. The Company regularly reviews the estimate of total contract time to ensure such estimates remain appropriate taking into account actual contract stage of completion, remaining time to complete and any identified changes to the contract scope. Remaining time to complete depends on the specific contract tasks and the complexity of the contract and can include geographical site selection and initiation, patient enrolment, patient testing and level of results analysis required. While we may routinely adjust time estimates, estimates and assumptions historically have been accurate in all material respects in the aggregate. If we do not accurately estimate the resources required or the scope of the work to be performed, or do not manage our projects properly within the planned cost or satisfy our obligations under the contracts, then future results may be significantly and negatively affected. Goodwill We review our goodwill for impairment annually, or more frequently if facts or circumstances warrant such a review. We evaluate goodwill for impairment by comparing the fair value of each reporting segment to its carrying 26 value. Fair value is determined using the market approach, by assessing the market value of each reporting unit, and the income approach, based on estimated discounted future cash flows. Estimates and judgments used include those relating to commercial risk, revenue and cost projections, our intention with respect to the acquired goodwill, the impact of competition, the impact of any reorganization or change of our business focus, the level of third party interest in our operations and market conditions. If the implied fair value of reporting unit goodwill is lower than its carrying amount, goodwill is impaired and written down to its implied fair value. If we were to use different estimates or judgments, particularly with respect to expected revenue and cost projections or the impact of any reorganization or change of business focus, a material impairment charge to the statement of operations could arise. We believe that we have used reasonable estimates and judgments in assessing the carrying value of our goodwill. Taxation Given the global nature of our business and the multiple taxing jurisdictions in which we operate, the determination of the Company’s provision for income taxes requires significant judgments and estimates, the ultimate tax outcome of which may not be certain. Although we believe our estimates are reasonable, the final outcome of these matters may be different than those reflected in our historical income tax provisions and accruals. Such differences could have a material effect on our income tax provision and results in the period during which such determination is made. Deferred tax assets and liabilities are determined using enacted or substantially enacted tax rates for the effects of net operating losses and temporary differences between the book and tax bases of assets and liabilities. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. While management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment, there can be no assurance that these deferred tax assets may be realizable. We operate within multiple taxing jurisdictions and are subject to audits in these jurisdictions. These audits can involve complex issues which may require an extended period of time for resolution. Management believe that adequate provisions for income taxes have been made in the financial statements. Inflation We believe that the effects of inflation generally do not have a material adverse impact on our operations or financial conditions. New Accounting Pronouncements In October 2008, the FASB issued FSP 157-3, Determining the Fair Value of a Financial Asset When the Market for That Asset Is Not Active” (FSP 157-3). FSP 157-3 clarifies the application of SFAS No. 157 in a market that is not active and addresses application issues such as the use of internal assumptions when relevant observable data does not exist, the use of observable information when the market is not active and the use of market quotes when assessing the relevance of observable and unobservable data. FSP 157-3 is effective for all periods presented in accordance with SFAS No. 157. The Company does not expect the adoption of FSP 157-3 to have a material impact on the financial statements. In April 2008, the FASB issued FSP 142-3 Determination of the Useful Life of Intangible Assets (FSP 142-3). FSP 142-3 amends the factors an entity should consider in developing renewal or extension assumptions used in determining the useful life of recognized intangible assets under FASB Statement No. 142 Goodwill and Other Intangible Assets (SFAS No. 142). FSP 142-3 applies prospectively to intangible assets that are acquired individually or with a group of other assets in a business combination or asset acquisition. The Company does not expect the adoption of FSP 142-3 to have a material impact on the financial statements. In December 2007, the FASB issued FASB Statement No. 141R, Business Combinations (SFAS No. 141R) and FASB Statement No. 160, Noncontrolling Interests in Consolidated Financial Statements– an amendment to ARB No. 51 27 (SFAS No. 160). SFAS No. 141R and SFAS No. 160 require most identifiable assets, liabilities, noncontrolling interests, and goodwill acquired in a business combination to be recorded at “full fair value” and require noncontrolling interests (previously referred to as minority interests) to be reported as a component of equity, which changes the accounting for transactions with noncontrolling interest holders. Both Statements are effective for periods beginning on or after December 15, 2008, and earlier adoption is prohibited. SFAS No. 141R will be applied to business combinations occurring after the effective date. SFAS No. 160 will be applied prospectively to all noncontrolling interests, including any that arose before the effective date. The Company does not expect the adoption of SFAS No. 141R and SFAS No. 160 to have a material impact on the financial statements. In September 2006, the FASB issued FASB Statement No. 157, Fair Value Measurement (SFAS No. 157). Statement 157 defines fair value, establishes a framework for the measurement of fair value, and enhances disclosures about fair value measurements. The Statement does not require any new fair value measures. The Statement is effective for fair value measures already required or permitted by other standards for fiscal years beginning after November 15, 2007. The Company was required to adopt SFAS No. 157 beginning on January 1, 2008. SFAS No. 157 is required to be applied prospectively, except for certain financial instruments. Any transition adjustment will be recognized as an adjustment to opening retained earnings in the year of adoption. In November 2007, the FASB proposed a one-year deferral of SFAS No. 157’s fair-value measurement requirements for nonfinancial assets and liabilities that are not required or permitted to be measured at fair value on a recurring basis. The adoption of SFAS No. 157 has not had a material impact on the financial statements. 28 Item 6. Directors, Senior Management and Employees. Directors and Senior Management The following table and accompanying biographies set forth certain information concerning each of ICON plc’s directors, officers and other key employees as of December 31, 2008. Name Age Position Dr. John Climax (1)(5) . . . . . . . . . . 56 Peter Gray (1)(5) . . . . . . . . . . . . . . 54 Ciaran Murray (1)(5) . . . . . . . . . . . 46 Dr. Ronan Lambe . . . . . . . . . . . . . 69 Thomas Lynch (2)(3)(4) . . . . . . . . . 52 Edward Roberts (2)(3)(4) . . . . . . . . . 74 Shuji Higuchi . . . . . . . . . . . . . . . . 68 Dr. Bruce Given (2)(3)(4) . . . . . . . . 54 Professor Dermot Kelleher . . . . . . . 53 William Taaffe . . . . . . . . . . . . . . . 60 Dr. John Hubbard . . . . . . . . . . . . . 52 Robert Scott-Edwards . . . . . . . . . . . 55 Sean Leech . . . . . . . . . . . . . . . . . . 38 Dr. Thomas Frey . . . . . . . . . . . . . . 56 Josephine Coyle . . . . . . . . . . . . . . 51 Eimear Kenny . . . . . . . . . . . . . . . . 39 Simon Holmes . . . . . . . . . . . . . . . 42 Michael McGrath . . . . . . . . . . . . . . 46 (1) Executive Officer of the Company. (2) Member of Compensation Committee. (3) Member of Audit Committee. (4) Member of Nomination Committee. (5) Member of Executive Committee. Chairman of the Board, Director Chief Executive Officer, Director Chief Financial Officer Director Director Director Director Director Director President Corporate Development President ICON Clinical Research President ICON Laboratories President ICON Contracting Solutions President ICON Development Solutions Vice President for Corporate Quality Assurance Vice President for Strategic Human Resources Vice President Group Marketing and Market Development Senior Vice President of Group Information Technology Dr. John Climax, one of the Company’s co-founders, has served as a director of the Company and its subsidiaries since June 1990. Dr. Climax served as Chief Executive Officer from June 1990 to October 2002 and was appointed Chairman of the Board in November 2002. Dr. Climax has over 22 years of experience in the contract research industry in both Europe and the United States. Dr. Climax received his primary degree in pharmacy in 1977 from the University of Singapore, his masters in applied pharmacology in 1979 from the University of Wales and his PhD. in pharmacology from the National University of Ireland in 1982. Peter Gray has served as the Chief Executive Officer of ICON and its subsidiaries since November 2002. He served as the Group Chief Operating Officer of ICON and its subsidiaries from June 2001, and was Chief Financial Officer from June 1997 to June 2001. He has been a director of the Company since June 1997. Mr. Gray has over 17 years experience in the pharmaceutical services industry and has also worked in the engineering and food sectors. Mr. Gray received a degree in Law from Trinity College Dublin in 1977 and became a chartered accountant in 1980. Ciaran Murray was appointed as Chief Financial Officer of ICON and its subsidiaries in October 2005. Mr. Murray developed his experience in senior financial positions in the technology and food sectors, in such companies as Kraft Foods, Inc. and Novell, Inc. Prior to joining ICON, Mr. Murray served as the CFO of Codec Systems from 1999 to 2005, a technology company headquartered in Ireland. Mr. Murray is a business graduate of University College Dublin. He trained as a chartered accountant with PricewaterhouseCoopers and is a Fellow of the Institute of Chartered Accountants in Ireland. 29 Dr. Ronan Lambe, one of the Company’s co-founders, served as Chairman of the Board of the Company from June 1990 to November 2002. He currently holds a position as an outside director since January 2008. Dr. Lambe has over 25 years of experience in the contract research industry in Europe. Dr. Lambe attended the National University of Ireland where he received his Bachelor of Science degree in chemistry in 1959, his masters in biochemistry in 1962 and his PhD. in pharmacology in 1976. Thomas Lynch has served as an outside director of the Company since January 1996. Mr. Lynch served as a director of Nanogen Inc., from 1996 to 2000. Mr. Lynch is currently Chairman and Chief Executive Officer of Amarin Corporation plc, a director of Royal Opera House (Covent Garden) and a non-executive director of IDA Ireland. In the period from May 1993 to July 2004, Mr. Lynch held several senior positions in Elan Corporation, plc, a specialty pharmaceutical company, including Executive Vice President, Chief Financial Officer, Vice Chairman and Senior Advisor to the Chairman of the Board of Elan Corporation, plc. Mr. Lynch was a partner at KPMG from May 1990 to May 1993. Edward Roberts has served as an outside director of the Company since February 1998. Mr. Roberts was Managing Director of the Pharmaceutical Division of Merck KGaA from 1990 to 1998. Prior to that, he held a number of senior management positions with Eli Lilly International in Europe and the United States. Mr. Roberts has over 40 years of experience in the pharmaceutical industry. Mr Roberts serves as Chairman of Merz & Co. GmbH and is also on the Board of Lupin. Mr. Shuji Higuchi has served as an outside director of the Company since September 2004. Dr. Higuchi has over 40 years of experience in the pharmaceutical industry. Dr. Higuchi is currently Director of R&D and Corporate Integration, Kyoto University Hospital, Japan. Prior to this Dr. Higuchi has served as President of Takeda Pharma GmbH from 1983 to 1992, President of Takeda Europe R&D Centre, Frankfurt / London from 1992 to 2002, and served as a Corporate Officer of Takeda Chemical Industries Limited, Japan from 1999 to 2002. Dr. Bruce Given has served as an outside director of the Company since September 2004. From March 2002 until June 2007 he served as President and Chief Executive Officer of Encysive Pharmaceuticals Inc. Previously, Dr. Given has held various positions in Johnson & Johnson group companies. Dr. Given obtained his doctorate from the University of Chicago in 1980. Professor Dermot Kelleher has served as an outside director of the Company since May 2008. Professor Kelleher is currently Head of the School of Medicine at Trinity College, Dublin, Ireland and Director of the Institute of Molecular Medicine in Dublin. William Taaffe has served as President Corporate Development since April 2005. Prior to this Mr. Taaffe served as President and Chief Executive Officer of ICON Clinical Research - U.S. since 1993. Mr. Taaffe has over 30 years of experience in the contract research and pharmaceutical industries in Ireland, Canada and the United States. Mr. Taaffe received his bachelor of science degree in 1970 from University College Dublin. Dr. John W. Hubbard has served as President of ICON Clinical Research since March 2007. Previously he served as President of ICON Clinical Research - U.S. since April 2005 and as Chief Operating Officer, U.S Operations since October 1999. Dr. Hubbard has more than 20 years of experience in pharmaceutical research and development. He has held positions of increasing responsibility at Revlon Health Care Group, Hoechst Marion Roussel Pharmaceuticals, Parexel International Corporation, and from July 1997 until joining ICON, he held the position of Senior Vice President of Clinical Research Operations at Clinical Studies, an industry leading site management organization and division of Innovative Clinical Solutions, Ltd. Dr. Hubbard received a B.S. in Psychology/Biology from the University of Santa Clara, a Ph.D. in Cardiovascular Physiology from the University of Tennessee, and was a NIH Postdoctoral Fellow in Cardiovascular Pharmacology at the University of Texas Health Sciences Center. Robert Scott-Edwards, has served the Company as President of ICON Laboratories since August 2004, having previously held the position of Vice President, Sales & Marketing for ICON Laboratories since June 2000. Prior to joining ICON, Mr. Scott-Edwards held various senior positions at Bristol-Myers Squibb from 1979 through 1997. Mr. Scott-Edwards began his career in the pharmaceutical industry in 1971 at Wyeth. Sean Leech has served as President of ICON Contracting Solutions since March 2007. Prior to this Mr. Leech served as Executive Vice President Commercial and Organization Development since October 2005, as the Chief Financial Officer of ICON and its subsidiaries since June 2001 and Group Vice President of Finance from June 1999. 30 Mr. Leech was Group Financial Controller of Jones Group plc, a shipping, manufacturing and fuel distribution company based in Ireland, from 1997 to 1999. Mr. Leech is an associate member of the Chartered Institute of Management Accountants. Dr. Thomas Frey has served as President of ICON Developments Solutions since June 2005. He previously held positions as Chief Operating Officer for ICON Clinical Research Europe from June 2001 and Vice President of ICON Clinical Operations Europe from January 2000 to May 2005. Dr. Frey has 20 years experience in pharmaceutical research and development. He started his career in 1987 with Hoechst Pharmaceuticals. From 1995 to the end of 1999 he was Senior Director of Clinical Development Europe at Hoechst Pharmaceuticals. Dr. Frey received his medical degree in 1980 from the University of Heidelberg. Josephine Coyle has served as Vice President for Corporate Quality Assurance since April 2000. Ms. Coyle has held positions of increasing responsibility in ICON since August 1992 and previously held the position of Director of Quality Assurance. Eimear Kenny, has served as Vice President for Strategic Human Resources since April 2007, having previously held the position of Vice President of Human Resources for ICON Clinical Research Europe and Rest of World since joining the Company in November 1999. Prior to joining ICON, Ms. Kenny was HR Manager for GE Global Consumer Finance Ireland. Ms. Kenny holds a degree in both business studies from Portobello College, Dublin and human resource management from the National College of Ireland. She is also a Member of the Chartered Institute of Personnel and Development. Simon Holmes has served as Vice President Group Marketing and Market Development since November 2007. In this role Mr Holmes is responsible for ICON’s global marketing function and for managing ICON’s internal process for the proactive identification and evaluation of potential acquisition candidates. Prior to this role, Mr. Holmes was Group Director of Marketing, a position he assumed on joining ICON in July 2005. Mr. Holmes has held senior positions within Microsoft, LogicaCMG and Cable and Wireless. A graduate of the University of East Anglia and Cambridge University he holds an MBA from the UCD Smurfit Business School. Michael McGrath has served as Senior Vice President of Group Information Technology since June 2007. He joined ICON in December 2002 as Director for Information Technology of Europe before moving to a role as Global Vice President of Information Technology for the Clinical Research Division. He previously held a number of senior Information Technology positions in the Financial Services Industry with GE Capital and Woodchester Bank Ltd. Prior to this he worked as an IT Consultant and also as a Software Engineer. He has over 15 years experience in the IT industry across many areas including Pharmaceuticals, Financial Services and Utilities. He holds an MSc in Information Technology Management from Dublin City University and a Higher Diploma in Electronic Engineering. Board of Directors ICON’s Articles of Association provide that, unless otherwise determined by ICON at a general meeting, the number of directors shall not be more than 15 nor less than 3. At each annual general meeting, one third of the directors who are subject to retirement by rotation, rounded down to the next whole number if it is a fractional number, shall retire from office. The directors to retire shall be those who have been longest in office, but as between persons who became or were last re-appointed on the same day, those to retire shall be determined, unless otherwise agreed, by lot. Accordingly, at the annual general meeting of ICON to be held in 2009, it is anticipated that two directors will retire by rotation and offer themselves for re-election, such directors to be determined, unless otherwise agreed, by lot. Any additional director appointed by us shall hold office until the next annual general meeting and will be subject to re-election at that meeting. Board committees ICON established a compensation committee and an audit committee in 1998, a nomination committee in 2004, and an executive committee in 2005, all of which are committees of the Board of Directors and are, with the exception of the Executive Committee, composed of non-executive directors of ICON plc. Compensation Committee The Compensation Committee comprises Thomas Lynch (Chairman), Edward Roberts, and Dr. Bruce Given. It deals with all aspects of senior executive remuneration. The committee aims to ensure that remuneration 31 packages are competitive so that individuals are appropriately rewarded relative to their responsibility, experience and value to ICON. Annual bonuses for executive directors are determined by the committee based on the achievement of ICON’s objectives. Audit Committee The Audit Committee comprises Edward Roberts (Chairman), Thomas Lynch and Dr. Bruce Given. It reviews the annual report, the quarterly earnings releases, the effectiveness of the system of internal controls, compliance with our ethical code and legal requirements, and approves the appointment and removal of the external auditors. It also addresses all issues raised and recommendations made by the external auditors and pre-approves all auditor services. Nomination Committee The Nomination Committee comprises Thomas Lynch (Chairman), Edward Roberts and Dr. Bruce Given. On an ongoing basis it reviews the membership of the board of directors and board committees. It identifies and recommends individuals to fill any vacancy that is anticipated or arises on the board of directors. It reviews and recommends the corporate governance principles of the Company. Executive Committee The Executive Committee comprises Dr. John Climax, Peter Gray (Chairman) and Ciaran Murray. Established in March 2005, this Committee is responsible for the management of the Company in intervals between meetings of the Board and exercises business judgment to act in what the Committee members reasonably believe to be in the best interest of the Company and its shareholders. All powers exercised by the Executive Committee are ratified at board meetings. This Committee convenes as often as it determines to be necessary or appropriate. The aggregate compensation (including share-based compensation of $0.4m) paid by ICON to all persons who served in the capacity of director or executive officer in 2008 (9 persons) was approximately $4.5 million, but does not include expenses reimbursed to directors and executive officers (including business travel, professional and business association dues and expenses). As of December 31, 2008, options granted to directors and executive officers of ICON to purchase an aggregate of 407,200 of our ordinary shares were outstanding. The options are exercisable at prices between $7.00 and $36.04 and expire between January 11, 2010 and May 27, 2016. In addition, our officers are eligible to participate in the Company’s equity incentive plans, including the Company’s share options plans and restricted share unit plan. See Note 10 to the Consolidated Financial Statements. Employees We employed 6,975, 5,610 and 4,290 people for the years ended December 31, 2008, December 31, 2007, and December 31, 2006, respectively. Our employees are not unionized and we believe that our relations with our employees are good. 32 Share Ownership The following table sets forth certain information regarding beneficial ownership of our ordinary shares (including Amercian Depository Securities, ADS’s) as of February 19, 2009, by all of our current directors and executive officers. Unless otherwise indicated below, to our knowledge, all persons listed below have sole voting and investment power with respect to their ordinary shares, except to the extent authority is shared by spouses under applicable law. Name of Owner or Identity of Group Dr. John Climax No. of Shares (1) 3,107,568 % of total Shares 5.3% Dr. Ronan Lambe 725,380 1.3% Mr. Peter Gray 444,288 0.8% Mr. Ciaran Murray Mr. Thomas Lynch — 4 Mr. Edward Roberts 16,004 Mr. Shugi Higuchi Dr. Bruce Given — — Professor Dermot Kelleher — — — — — — — No. of Options (2) 20,000 20,000 20,000 12,000 12,000 10,000 12,000 6,000 6,000 4,000 4,000 2,000 2,000 20,000 20,000 20,000 12,000 12,000 14,000 60,000 18,000 16,000 14,000 1,200 2,400 2,400 3,200 4,000 2,000 2,000 4,000 4,000 4,000 2,000 6,000 4,000 4,000 4,000 2,000 4,000 4,000 4,000 2,000 6,000 Exercise price $ 7.25 $ 7.00 $ 8.88 $ 11.00 $ 21.25 $ 35.33 $ 7.25 $ 7.00 $ 8.88 $ 8.60 $ 11.00 $ 21.25 $ 35.33 $ 7.25 $ 7.00 $ 8.88 $ 11.00 $ 21.25 $ 35.33 $ 10.42 $ 11.00 $ 21.25 $ 35.33 $ 7.00 $ 8.88 $ 8.60 $ 11.00 $ 21.25 $ 35.33 $ 8.88 $ 8.60 $ 11.00 $ 21.25 $ 35.33 $ 8.88 $ 8.60 $ 11.00 $ 21.25 $ 35.33 $ 8.60 $ 11.00 $ 21.25 $ 35.33 $ 36.04 Expiration Date January 11, 2010 January 21, 2011 February 4, 2012 February 3, 2014 February 16, 2015 February 26, 2016 January 11, 2010 January 21, 2011 February 4, 2012 February 24, 2013 February 3, 2014 February 16, 2015 February 26, 2016 January 11, 2010 January 21, 2011 February 4, 2012 February 3, 2014 February 16, 2015 February 26, 2016 January 17, 2014 February 3, 2014 February 16, 2015 February 26, 2016 January 21, 2011 February 4, 2012 February 24, 2013 February 3, 2014 February 16, 2015 February 26, 2016 February 4, 2012 February 24, 2013 February 3, 2014 February 16, 2015 February 26, 2016 February 4, 2012 February 24, 2013 February 3, 2014 February 16, 2015 February 26, 2016 February 24, 2013 February 3, 2014 February 16, 2015 February 26, 2016 May 27, 2016 (1) As used in this table, each person has the sole or shared power to vote or direct the voting of a security, or the sole or shared investment power with respect to a security (i.e. the power to dispose, or direct the disposition, of a security). A person is deemed as of any date to have “benefi- cial ownership” of any security if that such person has the right to acquire such security within 60 days after such date. (2) The title of securities covered by all of the above options are non-revenue qualified. 33 Employee Share Option Schemes On July 21, 2008, the Company adopted the Employee Share Option Plan 2008 (the “2008 Employee Plan”) pursuant to which the Compensation Committee of the Company’s Board of Directors may grant options to any employee, or any director holding a salaried office or employment with the Company or a Subsidiary for the purchase of ordinary shares. On the same date, the Company also adopted the Consultants Share Option Plan 2008 (the “2008 Consultants Plan”), pursuant to which the Compensation Committee of the Company’s Board of Directors may grant options to any consultant, adviser or non-executive director retained by the Company or any Subsidiary for the purchase of ordinary shares. Each option granted under the 2008 Employee Plan or the 2008 Consultants Plan (together the “2008 Option plans”) will be an employee stock option, or NSO. Each grant of an option under the 2008 Options Plans will be evidenced by a Stock Option Agreement between the optionee and the Company. The exercise price will be specified in each Stock Option Agreement. An aggregate of 6.0 million ordinary shares have been reserved under the 2008 Employee Plan as reduced by any shares issued or to be issued pursuant to options granted under the 2008 Consultants Plan under which a limit of 400,000 shares applies. Further, the maximum number of ordinary shares with respect to which options may be granted under the 2008 Employee Plan during any calendar year to any employee shall be 400,000 ordinary shares. There is no individual limit under the 2008 Consultants Plan. No options may be granted under the plans after July 21, 2018. On July 21, 2008, the Company adopted the the 2008 Employees Restricted Share Unit Plan (the “2008 RSU Plan”) pursuant to which the Compensation Committee of the Company’s Board of Directors may select any employee, or any director holding a salaried office or employment with the Company or a Subsidiary to receive an award under the plan. An aggregate of 1.0 million ordinary shares have been reserved for issuance under the 2008 RSU Plan. Awards under the 2008 RSU may be settled in cash or shares. On January 17, 2003, the Company adopted the Share Option Plan 2003, (“the 2003 Plan”), pursuant to which the Compensation Committee of the Board may grant options to employees of the Company or its subsidiaries for the purchase of ordinary shares. Each option will be an employee stock option, or NSO. Each grant of an option under the 2003 Plan will be evidenced by a Stock Option Agreement between the optionee and the Company. The exercise price will be specified in each Stock Option Agreement. An aggregate of 6.0 million ordinary shares have been reserved under the 2003 Plan; and, in no event will the number of ordinary shares that may be issued pursuant to options awarded under the 2003 Plan exceed 10% of the outstanding shares, as defined in the 2003 Plan, at the time of the grant. Further, the maximum number of ordinary shares with respect to which options may be granted under the 2003 Plan during any calendar year to any employee shall be 400,000 ordinary shares. No options can be granted after January 17, 2013. Executive Officers and Directors Remuneration Compensation Discussion & Analysis Overview The Compensation Committee (the “Committee”) seeks to achieve the following goals with the Company’s executive compensation programs: to attract, motivate and retain key executives and to reward executives for value creation. The Committee seeks to foster a performance-oriented environment by tying a significant portion of each executive’s cash and equity compensation to the achievement of performance targets that are important to the Company and its shareholders. The Company’s executive compensation program has three elements: base salary, a bonus plan and equity incentives in the form of stock related awards granted under the Company’s equity incentive plans. All elements of executive compensation are determined by the Committee based on the achievement of ICON’s objectives. In the year ended December 31, 2008, the officers earned a bonus and the Company awarded executive officers equity incentives in the form of stock options. 34 Base Salary and Bonus Incentive Total cash compensation is divided into a base salary portion and a bonus incentive portion. Base salary is established based on peer group and is adjusted based on individual performance and experience. The Committee targets total cash compensation at the peer group median of comparable Irish companies and peer CRO companies, adjusted upward or downward based on individual performance and experience. The Committee believes that the higher the executive’s level of responsibility within the Company, the greater the percentage of the executive’s compensation that should be tied to the Company’s performance. Target bonus incentive for executive officers is 80% of base salary. For fiscal 2008, based upon the Company’s income performance relative to the targets set by the Committee and individual objectives approved by the Committee, the Company’s named executive officers, excluding the Chief Executive Officer, earned an aggregate bonus of $780,002. Equity Incentive The Company’s executive officers are eligible to receive equity incentives, including stock options and restricted share units, granted under the Company’s equity incentive plans. If executive officers receive equity incentive grants, they are awarded annually at the first regularly scheduled meeting of the Committee in the fiscal year. Newly hired executive officers may receive sign-on grants, if approved by the Committee. In addition, the Committee may, in its discretion, issue additional equity incentive awards to executive officers if the Committee determines the awards are necessary for retention. The number of equity awards granted to each participant is determined primarily based on an award range determined by the Committee at the start of each year. The extent of existing options is not generally considered in granting equity awards, except that the Company occasionally grants an initial round of equity awards to newly recruited executives to provide them a stake in the Company’s success from the commencement of their employment. The Company granted equity incentive awards, in the form of share options, to executive officers in its fiscal years ended December 31, 2007 and 2008. On February 3, 2006, the Company granted performance-based stock options to certain executive officers. The purpose of these grants is to align management and shareholder interests as measured by both revenue growth and the stock markets’ assessment of the Company’s performance. Chief Executive Officer Compensation The Committee uses the same factors in determining the compensation of the Chief Executive Officer as it does for the other participants. The Chief Executive Officer’s base salary for the year ended December 31, 2008, was A€ 496,500 ($734,402). 35 Executive Compensation Summary compensation table - Year ended December 31, 2008 Name & principal position Year Salary All other Pension Bonus contribution compensation Subtotal Subtotal Share- based Total compensation compensation Euro (A€ ) Euro (A€ ) Euro (A€ ) Euro (A€ ) Euro (A€ ) USD ($) USD ($) USD ($) 387,500 496,500 Peter Gray, . . . . . . . . . . . . . 2008 Chief Executive Officer Ciaran Murray, . . . . . . . . . 2008 Chief Financial Officer John Climax, . . . . . . . . . . . 2008 Chairman Total . . . . . . . . . . . . . . . . . 2008 A€ 1,396,500 A€ 1,007,500 A€ 125,700 405,000 600,000 300,000 215,000 50,000 26,400 49,300 43,380 976,680 1,358,865 80,330 1,439195 18,466 559,866 780,935 175,135 956,070 62,280 1,117,280 1,558,240 71,717 1,629,957 A€ 124,126 A€ 2,653,826 $3,698,040 $327,182 $4,025,222 Summary compensation table - Year ended December 31, 2007 Name & principal position Year Salary Bonus Pension All other contribution compensation Subtotal Subtotal Share- based Total compensation compensation Euro (A€ ) Euro (A€ ) Euro (A€ ) Euro (A€ ) Euro (A€ ) USD ($) USD ($) USD ($) 320,000 400,000 Peter Gray, . . . . . . . . . . . . . 2007 Chief Executive Officer Ciaran Murray, . . . . . . . . . 2007 Chief Financial Officer John Climax, . . . . . . . . . . . 2007 Chairman Total . . . . . . . . . . . . . . . . . 2007 A€ 1,180,280 A€ 878,000 A€ 110,655 378,000 180,000 540,280 240,000 23,999 46,056 40,600 37,919 798,519 1,120,308 61,381 1,181,689 15,998 459,997 645,001 142,560 787,561 55,097 1,019,433 1,430,381 61,381 1,491,762 A€ 109,014 A€ 2,277,949 $3,195,690 $265,322 $3,461,012 Grant of Plan-Based Awards - Fiscal 2008 With the exception of the bonus element of compensation mentioned above, there were no plan based awards for any of the named executive officers in fiscal 2008. 36 Director Compensation Summary compensation table - Year ended December 31, 2008 Name Year Salary Company Pension contribution All other compensation Subtotal Subtotal compensation Share- based Director’s Total fees compensation Euro (A€ ) Euro (A€ ) Euro (A€ ) Euro (A€ ) USD ($) John Climax . . . . . . . . . Peter Gray . . . . . . . . . . . Ronan Lambe . . . . . . . . Thomas Lynch . . . . . . . . Edward Roberts . . . . . . . Shuji Higuchi . . . . . . . . Bruce Given . . . . . . . . . Dermot Kelleher . . . . . . Total . . . . . . . . . . . . . . . 2008 2008 2008 2008 2008 2008 2008 2008 600,000 496,500 — — — — — — A€ 1,096,500 50,000 49,300 — — — — — — 1,558,240 1,358,865 118,150 — — — — — A€ 99,300 A€ 978,160 A€ 2,173,960 $3,035,255 1,117,280 976,680 80,000 — — — — — 467,280 430,880 80,000 — — — — — USD ($) 71,717 80,330 19,861 23,482 23,503 23,503 18,538 10,779 USD ($) — — 40,000 55,000 65,000 40,000 45,000 21,000 USD ($) 1,629,957 1,439,195 178,011 78,482 88,503 63,503 63,538 31,779 $271,713 $266,000 $3,572,968 Summary compensation table - Year ended December 31, 2007 Name Year Salary Company Pension contribution All other compensation John Climax . . . . . . . . . Peter Gray . . . . . . . . . . . Ronan Lambe . . . . . . . . Thomas Lynch . . . . . . . . Edward Roberts . . . . . . . Shuji Higuchi . . . . . . . . Bruce Given . . . . . . . . . 2007 2007 2007 2007 2007 2007 2007 Euro (A€ ) 540,280 400,000 104,394 — — — — Total . . . . . . . . . . . . . . . A€ 1,044,674 A€ Euro (A€ ) 46,056 40,600 4,163 — — — — 90,819 A€ Euro (A€ ) 433,097 357,919 3,903 — — — — 794,919 A€ Subtotal Subtotal Euro (A€ ) USD ($) 1,019,433 798,519 112,460 — — — — 1,430,381 1,120,308 148,402 — — — — 1,930,412 $2,699,091 Share- based compensation Director’s Total fees compensation USD ($) 61,381 61,381 19,156 24,475 22,495 18,589 13,624 USD ($) — — — 55,000 65,000 40,000 45,000 USD ($) 1,491,762 1,181,689 167,558 79,475 87,495 58,589 58,624 $221,101 $205,000 $3,125,192 37 Outstanding Equity Interests Received as Compensation Outstanding Equity Awards Table The following table sets forth information concerning stock options held by the named Executive Officers at December 31, 2008: Name Peter Gray Ciaran Murray John Climax No. of securities underlying unexercised options – exercisable No. of securities underlying unexercised options – unexercisable Option awards Equity incentive plan awards: No. of securities underlying unexercised unearned options 20,000 20,000 16,000 4,800 2,400 — — 7,200 3,200 — 20,000 20,000 16,000 4,800 2,400 — — — 4,000 7,200 9,600 14,000 60,000 10,800 12,800 14,000 — — 4,000 7,200 9,600 10,000 — — — — — — — — — — — — — — — — Option exercise price ($) $ 7.25 $ 7.00 $ 8.88 $ 11.00 $ 21.25 $ 35.33 $ 10.42 $ 11.00 $ 21.25 $ 35.33 $ 7.25 $ 7.00 $ 8.88 $ 11.00 $ 21.25 $ 35.33 Option expiration date Jan 11, 2010 Jan 21, 2011 Feb 4, 2012 Feb 3, 2014 Feb 16, 2015 Feb 26, 2016 Jan 17, 2014 Feb 3, 2014 Feb 16, 2015 Feb 26, 2016 Jan 11, 2010 Jan 21, 2011 Feb 4, 2012 Feb 3, 2014 Feb 16, 2015 Feb 26, 2016 All information in this table relates to nonqualified stock options. The Company has not granted any stock appreciation rights (“SARs”) in fiscal year 2008. Substantially all options become exercisable in five equal installments each year beginning on the first anniversary of the grant date. Options Exercised Table There were no options exercised during fiscal 2008 by any of the named executive officers. Retirement Plans & Other Post-Employment Payments & Benefits Pension Plan All named executive officers are eligible to participate in a defined contribution pension plan (the “Plan”). The Company matches each participant’s contributions up to a percentage of their annual compensation. Contributions to this plan are recorded as an expense in the Consolidated Statement of Operations. Total company contributions for the named executive officers for the year ended December 31, 2008, was A€ 125,700 ($185,782). Information regarding the Company’s retirement plans can be found in Note 9 to the Consolidated Financial Statements “Employee Benefits”. Non-qualified Defined Contribution and Deferred Compensation Plans None of the named executive officers are involved in any non-qualified defined contribution plan or receives any nonqualified deferred compensation. 38 Disclosure of Compensation Agreements Employment Contracts, Termination of Employment and Change in Control Arrangements The Company does not have any Termination or Change of Control Agreements with its named executive officers. Directors’ and Executive Officers’ service agreements and letters of engagement Mr. Peter Gray Mr. Peter Gray has served as the Chief Executive Officer since November 2002. He served as the Chief Operating Officer of the Company from June 2001 to November 2002 and as an Executive Director of the Company since June 1997. The service agreement with Mr. Gray is terminable on 12 months notice by either party. He is entitled to receive a bonus to be agreed by the Committee. He is also entitled to receive a pension contribution, company car and medical insurance cover for himself and his dependants. He currently holds 98,000 ordinary share options at exercise prices ranging from $7.00 to $35.33 per share. His service agreement requires him to devote his full time and attention to his duties for the Company excepting certain non-executive positions authorized by the Board. The agreement includes certain post termination clauses including non-disclosure, non-competition and non-solicitation provisions. Mr. Ciaran Murray Mr. Ciaran Murray has served as the Chief Financial Officer since October 2005. The service agreement with Mr. Murray is terminable on 12 months notice by either party. He is entitled to receive a bonus to be agreed by the Committee. He is also entitled to receive a pension contribution, a company car and medical insurance cover for himself and his dependants. He currently holds 108,000 ordinary share options at exercise prices ranging from $10.42 to $35.33 per share. His service agreement requires him to devote his full time and attention to his duties for the Company excepting certain non-executive positions authorized by the Board. The agreement includes certain post-termination clauses including non-disclosure, non-competition and non-solicitation provisions. Dr. John Climax Dr. John Climax, one of the Company’s co-founders, has served as a Director since June 1990, and Chief Executive Officer from June 1990 to October 2002. He was appointed Chairman of the Board in November 2002. The service agreement with Dr. Climax is terminable on 12 months notice by either party. He is entitled to receive a bonus to be agreed by the Committee. He is entitled to receive a pension contribution, company car and medical insurance cover for himself and his dependants. He currently holds 94,000 ordinary share options at exercise prices ranging from $7.00 to $35.33 per share. His service agreement requires him to devote his full time and attention to his duties for the Company excepting certain non-executive positions authorized by the Board. The agreement includes certain post-termination clauses including non-disclosure, non-competition and non-solicitation provisions. 39 Item 7. Major Shareholders and Related Party Transactions. The following table sets forth certain information regarding beneficial ownership of ICON’s ordinary shares (including ADSs) as of February 19, 2009 (i) by each person that beneficially owns more than 5% of the outstanding ordinary shares, based upon publicly available information; and (ii) by all of our current directors and executive officers as a group. Unless otherwise indicated below, to our knowledge, all persons listed below have sole voting and investment power with respect to their ordinary shares, except to the extent authority is shared by spouses under applicable law. Name of Owner or Identity of Group No. of Shares (1) Percent of Class Fidelity Group Companies (3) . . . . . . . . . . . . . . . . . . . . . . . . . Dr. John Climax (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Select Equity Group, Inc. (3) . . . . . . . . . . . . . . . . . . . . . . . . . . All directors and officers as a group (4) . . . . . . . . . . . . . . . . . . . 5,422,202 3,201,568 2,927,223 4,700,644 9.3% 5.5% 5.0% 8.0% (1) As used in this table, each person has the sole or shared power to vote or direct the voting of a security, or the sole or shared investment power with respect to a security (i.e., the power to dispose, or direct the disposition, of a security). A person is deemed as of any date to have “benefi- cial ownership” of any security if that such person has the right to acquire such security within 60 days after such date. Note that all figures have been amended to reflect the Bonus Issues which took place with an effective date of October 13, 2006 and August 8, 2008. (2) Includes 3,107,568 ADSs held by Poplar Limited, a Jersey company controlled by Dr. Climax, and options to purchase 94,000 ADSs. (3) Neither the Company nor any of its officers, directors or affiliates holds any voting power in this entity. (4) Includes 407,200 ordinary shares issuable upon the exercise of stock options granted by the Company. ICON plc, is not directly or indirectly, owned or controlled by another corporation or by any government. Given that certain of the ordinary shares and American Depositary Shares (“ADRs”) are held by brokers or other nominees, the number of holders of record or registered holders in the United States is not representative of the number of beneficial holders or of the residence of beneficial holders. Based on management’s review of relevant filings with the Securities and Exchange Commission and other publicly available information, the Company believes that the number of ordinary shares (including ADSs) held by holders of record that are residents of the United States is below 50% and may include Fidelity Group Companies and Select Equity Group, Inc. The Company notes that of a total of 58,528,955 ordinary shares (including ADSs) of the Company which were issued and outstanding at February 19, 2008, 8,349,425 ordinary shares (including ADSs) were held by holders of record in the United States. Related Party Transactions As at December 31, 2008, Amarin Investment Holding Limited (a company controlled by Mr. Thomas Lynch), and Sunninghill Limited (a company controlled by Dr. John Climax) held 1.1 million and 1.5 million shares respectively in Amarin. These respective holdings equate to approximately 3.97% and 5.42% respectively, of Amarin’s issued share capital. Thomas Lynch also serves as Chairman and Chief Executive Officer of Amarin. Amarin is a neuroscience company focused on the research, development and commercialization of drugs for the treatment of central nervous system disorders. During the fiscal year ending May 31, 2005, Amarin contracted ICON Clinical Research Limited (a wholly owned subsidiary of ICON), to conduct a clinical trial on its behalf. The total potential value of this study is $7 million. During the year ended December 31, 2008, the Company recognized $0.2 million of revenue relating to the Amarin contract. At December 31, 2008, $0.3 million was outstanding to be received from Amarin on this trial. As at December 31, 2008, Dr. John Climax and Dr. Ronan Lambe held 3.05% and 2.94% respectively of the issued share capital of NuPathe Inc. (“NuPathe”). NuPathe is a specialty pharmaceutical company specializing in the acquisition and development of therapeutic products in the area of neuroscience. Prior to July 2008 Dr. Climax also served as a non-executive director and chairman of the compensation committee on the Board of NuPathe. During the year ending December 31, 2006, NuPathe engaged ICON Clinical Research Limited, a wholly owned subsidiary of ICON plc, in consulting and clinical trial related activities. During the year ended December 31, 2008, the Company recognized $0.1 million relating to the NuPathe contract. There were no amounts outstanding as at December 31, 2008. 40 Mr Edward Roberts has served as Chairman of Merz GmbH since 2003. Merz is an independent German pharmaceutical company focused on the development of drugs for the treatment of illnesses in the fields of neurology and psychiatry. ICON Clinical Research Limited, a wholly owned subsidiary of ICON plc, has entered into a number of contracts with Merz for the provision of consulting and clinical trial related activities. The total potential value of these contracts is $44.1 million. During the prior year ended December 31, 2008, ICON recognized a total of $7.6 million of revenue in relation to these activities. There were no amounts outstanding as at December 31, 2008. Prior to June 25, 2007, Dr. Bruce Given served as the President and Chief Executive Officer of Encysive Pharmaceuticals Inc. (“Encysive”). Encysive is a biopharmaceutical company specializing in the development and commercialization of synthetic, small molecule compounds. As of December 31, 2007, Dr. Bruce Given’s holdings in Encysive was less than 0.1% of the issued share capital. During the year ending December 31, 2003, Encysive engaged ICON Clinical Research Limited (a wholly owned subsidiary of ICON), in consulting and clinical trial related activities. During the year ended December 31, 2007, ICON recognized a total of $0.1 million of revenue in relation to these activities. No revenue was earned from these activities during the year ended December 31, 2008. As of December 31, 2007, Dr. Ronan Lambe held 1.4 million shares in AGI Therapeutics Limited (“AGI”), a specialty pharmaceutical company focused on developing drug therapies for gastrointestinal diseases and disorders. In January 2006, Dr. Ronan Lambe was appointed a non-executive director of AGI and took up the position of non- executive Chairman from February 2006. During September 2004, AGI engaged ICON Clinical Research Limited (a wholly owned subsidiary of ICON), in consulting and clinical trial related activities. The total value of this study was $2.8 million. No revenue was recognized during the years ended December 31, 2007 and December 31, 2008. There were no amounts outstanding as at December 31, 2007 and December 31, 2008. Item 8. Financial Information. Financial Statements See Item 18. Legal Proceedings ICON is not party to any litigation or other legal proceedings that we believe could reasonably be expected to have a material adverse effect on our business, results of operations and financial condition. Dividends We have not paid cash dividends on our ordinary shares and do not intend to pay cash dividends on our ordinary shares in the foreseeable future. Item 9. The Offer and the Listing ICON’s ADSs are traded on the NASDAQ National Market under the symbol “ICLR”. Our Depository for the ADSs is The Bank of New York. ICON also has a secondary listing on the Official List of the Irish Stock Exchange. No securities of ICON are traded in any other market. The following table sets forth the trading price for the dates indicated for ICON plc’s ADSs as reported by NASDAQ. Year Ending High Sales Price During Period Low Sales Price During Period May 31, 2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . May 31, 2005 . . . . . . . . . . . . . . . . . . . . December 31, 2005 (7 month transition period) December 31, 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . December 31, 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . December 31, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 11.52 $ 11.23 $ 12.63 $ 20.18 $ 32.40 $ 44.78 $ 6.47 $ 7.57 $ 7.53 $ 10.25 $ 18.34 $ 15.64 41 Quarter Ending High Sales Price During Period Low Sales Price During Period Mar 31, 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . June 30, 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sept 30, 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dec 31, 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mar 31, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . June 30, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sept 30, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dec 31, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 22.30 $ 24.83 $ 26.63 $ 32.40 $ 35.56 $ 39.12 $ 44.78 $ 39.66 $ 18.34 $ 20.83 $ 21.26 $ 25.36 $ 28.63 $ 29.52 $ 35.00 $ 15.64 Month Ending High Sales Price During Period Low Sales Price During Period July 31, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aug 31, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sept 30, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Oct 31, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Nov 30, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dec 31, 2008 $ 42.09 $ 44.78 $ 43.75 $ 39.66 $ 27.90 $ 24.37 $ 36.07 $ 40.00 $ 35.00 $ 18.67 $ 15.64 $ 17.27 All comparative figures above have been amended to reflect the Bonus Issues which took place with an effective date of August 8, 2008 and October 13, 2006. Item 10. Additional Information Exchange Controls and Other Limitations Affecting Security Holders Irish exchange control regulations ceased to apply from and after December 31, 1992. Except as indicated below, there are no restrictions on non-residents of Ireland dealing in domestic securities, which includes shares or depository receipts of Irish companies. Except as indicated below, dividends and redemption proceeds also continue to be freely transferable to non-resident holders of such securities. The Financial Transfers Act, 1992 gives power to the Minister for Finance of Ireland to make provision for the restriction of financial transfers between Ireland and other countries and persons. Financial transfers are broadly defined, and include all transfers which would be movements of capital or payments within the meaning of the treaties governing the European Communities. The acquisition or disposal of ADSs or ADRs representing shares issued by an Irish incorporated company and associated payments may fall within this definition. In addition, dividends or payments on redemption or purchase of shares and payments on a liquidation of an Irish incorporated company would fall within this definition. At present, the Financial Transfers Act, 1992 prohibits financial transfers involving certain persons connected with the former regime in Iraq, certain persons indicted by the International Criminal Tribunal for the former Yugoslavia and certain associated persons, Zimbabwe, the Islamic Republic of Iran, the Democratic Peoples Republic of Korea, the Republic of Lebanon, the Taliban of Afghanistan, Osama bin Laden and Al-Qaeda, Liberia, Libya, Burma/Myanmar, Uzbekistan, Sudan, Somalia, Cote D’Ivoire, the Democratic Republic of Congo, President Lukashenko and certain other officials of Belarus, and countries that harbor certain terrorist groups, without the prior permission of the Central Bank of Ireland. Any transfer of, or payment in respect of an ADS involving the government of any country or any person which is currently the subject of United Nations sanctions, any person or body controlled by any of the foregoing, or by any person acting on behalf of the foregoing, may be subject to restrictions pursuant to such sanctions as implemented into Irish law. The following countries and persons are currently the subject of such sanctions: Somalia, Sierra Leone, Sudan, Cote D’Ivoire, Democratic Republic of Congo, Liberia, individuals designated by the international independent investigation Commission or the Government of Lebanon, Democratic Peoples Republic of Korea, the Islamic Republic of Iran, Iraq, the Taliban of Afghanistan, Osama bin Laden and Al-Qaeda. There are no restrictions under the Company’s Articles of Association, or under Irish Law that limit the right of non-residents or foreign owners to hold or vote the Company’s ordinary shares or ADSs. 42 Memorandum and Articles of Association We hereby incorporate by reference the description of our Memorandum and Articles of Association located under the heading “Description of the Memorandum and Articles of Association of the Company” in our Form 6-K filed with the Securities Exchange Commission on December 5, 2008. On July 21, 2008, at ICON’s Annual General Meeting, the Articles of Association of ICON plc were amended to increase the authorized share capital. The following amendments were made: “That the authorized share capital of the Company be increased from A€ 2,400,000 divided into 40,000,000 Ordinary Shares of A€ 0.06 each, to A€ 6,000,000 divided into 100,000,000 Ordinary Shares of A€ 0.06 each.” On July 21, 2008, at ICON’s Annual General Meeting, the Articles of Association of ICON plc were amended to authorise the chairman to have a casting vote. The following amendments were made: “That Article 101(a) of the Company’s existing Articles of Association be deleted and replaced in its entirety with the following new Article 101(a): (a) Questions arising at any meeting of Directors shall be decided by a majority of votes. Where there is an equality of votes, the chairman of the meeting shall have a second or casting vote.” Material Contracts The Company leases all but one of its facilities under operating leases. Certain of these leases are considered to be material. Taxation General The following discussion is based on existing Irish tax law, Irish court decisions and the practice of the Revenue Commissioners of Ireland, and the convention between the United States and Ireland for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with respect to income and capital gains (the “Treaty”). This discussion does not purport to deal with the tax consequences of owning the ordinary shares for all categories of investors, some of which may be subject to special rules. Prospective purchasers of ordinary shares are advised to consult their own tax advisors concerning the overall tax consequences arising in their own particular situations under Irish law. Each prospective investor should understand that future legislative, administrative and judicial changes could modify the tax consequences described below, possibly with retroactive effect. As used herein, the term “U.S. Holder” means a beneficial owner of ordinary shares that (i) owns the ordinary shares as capital assets; (ii) is a U.S. citizen or resident, a U.S. corporation, an estate the income of which is subject to U.S. federal income taxation regardless of its source or a trust that meets the following two tests: (A) a U.S. court is able to exercise primary supervision over the administration of the trust, and (B) one or more U.S. persons have the authority to control all substantial decisions of the trust; and for purposes of the discussion under Irish Taxation of U.S. Holders (A) is not a resident of, or ordinarily resident in, Ireland for the purposes of Irish tax; and (B) is not engaged in trade or business in Ireland through a permanent establishment. AS USED HEREIN, REFERENCES TO THE ORDINARY SHARES SHALL INCLUDE ADSs REPRESENTING SUCH ORDINARY SHARES AND ADRs EVIDENCING OWNERSHIP OF SUCH ADSs. Irish Taxation Irish corporation tax on income ICON is a public limited company incorporated and resident for tax purposes in Ireland. For Irish tax purposes, the residence of a company is in the jurisdiction where the central management and control of the company is located. Subject to certain exceptions, all Irish incorporated companies are deemed to be Irish tax resident. Companies which are resident in the Republic of Ireland are subject to Irish corporation tax on their total profits (wherever arising and, generally, whether or not remitted to the Republic of Ireland). The question of residence, by virtue of management and control, is essentially one of fact. It is the present intention of the Company’s 43 management to continue to manage and control the Company from the Republic of Ireland, so that the Company will continue to be resident in the Republic of Ireland. The standard rate of Irish corporation tax on trading income (with certain exceptions) is currently 12.5%. Patent exemption is available to Irish resident companies whose income derives from qualifying royalties or license fees paid in respect of qualifying patents. The main requirement to qualify for the exemption is that the research, planning, processing, experimentation, testing, devising, designing, developing or similar activity leading to the invention which is the subject of the patent is carried out in Ireland. Under Irish law, income from such qualifying patents is disregarded for taxation purposes. From January 1, 2008, there is an annual limit of 5 million Euro placed on qualifying patent income. To the extent that income arises above this threshold, it will be subject to Irish corporation tax at 25%. To the extent that the company is involved in the “manufacture” of goods in Ireland, income from this activity, in respect of its data processing operations carried out in Ireland (which is deemed to be manufacturing for Irish tax purposes) , can qualify for a 10% rate of tax. This relief is available until December 31, 2010, and thereafter the income will be taxed at the standard rate applicable to trading income which is currently 12.5%. Corporation tax is charged at the rate of 25% on a company’s non-trading income and certain types of trading income not eligible for the lower rates discussed above. Capital gains arising to an Irish resident company are liable to tax at 20% (22% for disposals made on or after 14 October 2008). However, a capital gains tax exemption has been introduced in Ireland in respect of disposals of certain qualifying shareholdings. The exemption from capital gains tax on the disposal of shares by an Irish resident company will apply where certain conditions are met. These conditions principally are: • • • • The company claiming the exemption must hold (directly or indirectly) at least 5% of the ordinary share capital of the company in which the interest is being disposed of, for a period of at least one year, within the two year period prior to disposal. The shares being disposed of must be in a company, which at the date of disposal, is resident in an EU Member State or in a state with which Ireland has signed a double tax agreement. The shares must be in a company which is primarily a trading company or else the company making the disposal together with its “5% plus subsidiaries” should be primarily a trading group. The shares must not derive the greater part of their value from land or mineral rights in the State. Taxation of Dividends Unless exempted, all dividends paid by ICON, other than dividends paid entirely out of exempt patent income (subject to conditions), will be subject to Irish withholding tax at the standard rate of income tax in force at the time the dividend is paid, currently 20%. An individual shareholder who is neither resident nor ordinarily resident for tax purposes in Ireland, but is resident in a country with which Ireland has signed a double tax treaty, which includes the United States, or in a member state of the European Union, other than Ireland (together a “Relevant Territory”), will be exempt from withholding tax provided he or she makes the requisite declaration. No dividend withholding tax will apply on the payment of a dividend from an Irish resident company to its Irish resident 51% parent company. Where the Irish company receiving the dividend does not hold at least 51% of the shares of the paying company, the dividend will be exempt if the Irish corporate shareholder makes the requisite declaration. are ultimately controlled by residents of a Relevant Territory; Non-Irish resident corporate shareholders that: • • • are resident in a Relevant Territory and are not controlled by Irish residents; have the principal class of their shares, or shares of a 75% parent, substantially and regularly traded on one or more recognized stock exchanges in a Relevant Territory or Territories; or • are wholly owned by two or more companies, each of whose principal class of shares is substantially and regularly traded on one or more recognized stock exchanges in a Relevant Territory or Territories; will be exempt from withholding tax on the production of the appropriate certificates and declarations. 44 U.S. Holders of ordinary shares (as opposed to ADSs: see below) should note, however, that these documentation requirements may be burdensome. As described below, these documentation requirements do not apply in the case of ADSs. Special arrangements are available in the case of an interest in shares held in Irish companies through American depositary banks using ADSs. The depositary bank will be allowed to receive and pass on a dividend from the Irish company without any deduction for withholding tax in the following circumstances: • • • the depositary has been authorized by the Irish Revenue Commissioners as a qualifying intermediary and such authorization has not expired or been revoked; and either the depositary bank’s ADS register shows that the beneficial owner has a U.S. address on the register; or if there is a further intermediary between the depositary bank and the beneficial owner, where the depositary bank receives confirmation from the intermediary that the beneficial owner’s address in the intermediary’s records is in the U.S. Income Tax Under certain circumstances, non-Irish resident shareholders will be subject to Irish income tax on dividend income. This liability is limited to tax at the standard rate and therefore, where withholding tax has been deducted, this will satisfy the tax liability. However, a non-Irish resident shareholder will not have an Irish income tax liability on dividends from the Company if the holder is neither resident nor ordinarily resident in the Republic of Ireland and the holder is: • • • • • an individual resident in the U.S. (or any other country with which Ireland has signed a double taxation treaty); a corporation that is ultimately controlled by persons resident in the U.S. (or any other country with which Ireland has signed a double taxation treaty); a corporation whose principal class of shares (or its 75% or greater parent’s principal class of shares) is substantially and regularly traded on a recognized stock exchange in an EU country or a country with which Ireland has signed a double taxation treaty; a corporation resident in another EU member state or in a country with which Ireland has signed a double taxation treaty, which is not controlled directly or indirectly by Irish residents; or a corporation that is wholly owned by two or more corporations each of whose principal class of shares is substantially and regularly traded on a recognized stock exchange in an EU country or a country with which Ireland has signed a double taxation treaty. U.S. Holders that do not fulfill the documentation requirements or otherwise do not qualify for the withholding tax exemption may be able to claim treaty benefits under the treaty. U.S. Holders that are entitled to benefits under the treaty will be able to claim a partial refund of the 20% withholding tax from the Irish Revenue Commissioners. Taxation of Capital Gains A person who is not resident or ordinarily resident in Ireland, has not been an Irish resident within the past five years and who does not carry on a trade in Ireland through a branch or agency will not be subject to Irish capital gains tax on the disposal of ordinary shares or ADSs, so long as the ordinary shares or ADSs, as the case may be, are either quoted on a stock exchange or do not derive the greater part of their value from Irish land or mineral rights. There are provisions to subject a person who disposes of an interest in a company while temporarily being non-Irish resident, to Irish capital gains tax. This treatment will apply to Irish domiciled individuals -: • who cease to be Irish resident; • who own the shares when they cease to be resident; • if there are not more than 5 years of assessment between the last year of Irish tax residence prior to becoming 45 temporarily non-resident and the tax year that he/she resumes Irish tax residency; • who dispose of an interest in a company during this temporary non-residence; and • the interest disposed of represents 5% or greater of the share capital of the company or is worth at least A€ 500,000. In these circumstances the person will be deemed, for Irish capital gains tax purposes, to have sold and immediately reacquired the interest in the company on the date of his or her departure and will be subject to tax at 20% of the taxable gain. Irish Capital Acquisitions Tax Irish capital acquisitions tax (referred to as CAT) applies to gifts and inheritances. Where a gift or inheritance is taken under a disposition made after December 1, 1999, it will be within the charge to CAT: • to the extent that the property of which the gift or inheritance consists is situated in the Republic of Ireland at the date of the gift or inheritance; • where the person making the gift or inheritance is or was resident or ordinarily resident in the Republic of Ireland at the date of the disposition under which the gift or inheritance is taken; • in the case of a gift taken under a discretionary trust where the person from whom the gift is taken was resident or ordinarily resident in the Republic of Ireland at the date he made the settlement, or at the date of the gift or, if he is dead at the date of the gift, at his death; or • where the person receiving the gift or inheritance is resident or ordinarily resident in the Republic of Ireland at the date of the gift or inheritance. The person who receives the gift or inheritance is primarily liable for CAT. A person is secondarily liable if he is the donor, his personal representative or an agent, trustee or other person in whose care the property constituting the gift or inheritance or the income therefrom is placed. Taxable gifts or inheritances received by an individual since December 5, 1991, from donors in the same threshold class are aggregated and only the excess over a specified tax-free threshold is taxed. The tax-free threshold is dependent on the relationship between the donor and the donees and the aggregation since December 5, 1991, of all previous gifts and inheritances, within the same tax threshold. The tax-free threshold amounts that apply during 2009 are: • A€ 27,127 (2008: A€ 26,060) in the case of persons who are not related to one another; • A€ 54,254 (2008: A€ 52,151) in the case of gifts or inheritances received from inter alia a brother or sister or from a brother or sister of a parent or from a grandparent; and • A€ 542,544 (2008: A€ 521,208) in the case of gifts and inheritances received from a parent (or from a grandparent by a minor child of a deceased child) and specified inheritances received by a parent from a child. Gifts and inheritances passing between spouses are exempt from CAT. A gift or inheritance of ordinary shares or ADSs will be within the charge to Irish capital acquisitions tax, notwithstanding that the person from whom or by whom the gift or inheritance is received is domiciled or resident outside Ireland. The Estate Tax Convention between Ireland and the United States generally provides for Irish capital acquisitions tax paid on inheritances in Ireland to be credited against U.S. federal estate tax payable in the United States and for tax paid in the United States to be credited against tax payable in Ireland, based on priority rules set forth in the Estate Tax Convention. The Estate Tax Convention does not apply to Irish capital acquisitions tax paid on gifts. Irish Probate Tax Irish probate tax was abolished under the Finance Act, 2001. No probate tax will arise on any assets passing in respect of a death occurring on or after December 6, 2000. 46 Irish Stamp Duty - Ordinary Shares Irish stamp duty, which is a tax on certain documents, is payable on all transfers of the ordinary shares (other than between spouses) whenever a document of transfer is executed. Where the transfer is attributable to a sale, stamp duty will be charged at a rate of 1%, rounded to the nearest Euro. The stamp duty is calculated on the amount or value of the consideration (i.e. purchase price) or, if the transfer is by way of a gift (subject to certain exceptions) or for consideration less than the market value, on the market value of the shares. Where the consideration for the sale is expressed in a currency other than Euro, the duty will be charged on the Euro equivalent calculated at the rate of exchange prevailing on the date of the transfer. Transfers of ordinary shares between associated companies (broadly, companies within a 90% group relationship, and subject to the satisfaction of certain conditions) are exempt from stamp duty in the Republic of Ireland. In the case of transfers of ordinary shares where no beneficial interest passes (e.g. a transfer of shares from a beneficial owner to his nominee), no stamp duty arises where the transfer contains the appropriate certificate and, in the absence of such certificate, a flat rate of A€ 12.70 (the nominal rate) will apply. Irish Stamp Duty - ADSs Representing Ordinary Shares A transfer by a shareholder to the depositary or custodian of ordinary shares for deposit under the deposit agreement in return for ADSs and a transfer of ordinary shares from the depositary or the custodian upon surrender of ADSs for the purposes of the withdrawal of the underlying ordinary shares in accordance with the terms of the deposit agreement will be stampable at the ad valorem rate if the transfer relates to a sale or contemplated sale or any other change in the beneficial ownership of such ordinary shares. However, it is not certain whether the mere withdrawal of ordinary shares in exchange for ADSs or ADSs for ordinary shares would be deemed to be a transfer of or change in the beneficial ownership which would be subject to stamp duty at the ad valorem rate. Where the transfer merely relates to a transfer where no change in the beneficial ownership in the underlying ordinary shares is effected or contemplated, no stamp duty arises where the transfer contains the appropriate certificate and, in the absence of such certificate, the nominal rate stamp duty of A€ 12.70 applies. Transfers of ADSs are exempt from Irish stamp duty as long as the ADSs are dealt in on the NASDAQ National Market or any recognized stock exchange in the United States or Canada. The person accountable for payment of stamp duty is the transferee or, in the case of a transfer by way of gift, or for a consideration less than the market value, all parties to the transfer. A late or inadequate payment of stamp duty will result in a liability to pay interest, penalties and fines. Documents on Display We are subject to the informational requirements of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and file reports and other information with the SEC. You may read and copy any of our reports and other information at, and obtain copies upon payment of prescribed fees from, the Public Reference Room maintained by the SEC at 100F Street N.E., Washington, D.C. 20549. In addition, the SEC maintains a Web site that contains reports, proxy and information statements and other information regarding registrants that file electronically with the SEC at http://www.sec.gov. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. We “incorporate by reference” information that we file with the SEC, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is an important part of this report and more recent information automatically updates and supersedes more dated information contained or incorporated by reference in this report. Our SEC file number for Exchange Act reports is 333-8704. As a foreign private issuer, we are exempt from the rules under the Exchange Act, prescribing the furnishing and content of proxy statements to shareholders. We will provide without charge to each person, including any beneficial owner, on the written or oral request of such person, a copy of any or all documents referred to above which have been or may be incorporated by reference in this report (not including exhibits to such incorporated information that are not specifically incorporated by reference into such information). Requests for such copies should be directed to us at the following address: ICON plc, South 47 County Business Park, Leopardstown, Dublin 18, Ireland, Attention: Ciaran Murray, telephone number: (353) 1 291 2000. Exemptions From Corporate Governance Listing Requirements Under the NASDAQ Marketplace Rules NASDAQ may provide exemptions from the NASDAQ corporate governance standards to a foreign private issuer when those standards are contrary to a law, rule or regulation of any public authority exercising jurisdiction over such issuer or contrary to generally accepted business practices in the issuer’s country of domicile, except to the extent that such exemptions would be contrary to United States federal securities laws. ICON, as a foreign private issuer, was granted an exemption in 1998 from provisions set forth in NASDAQ Rule 4350(f), which requires each issuer to provide for a quorum in its by-laws for any meeting of the holders of common stock, which shall in no case be less than 33.33% of the outstanding shares of the issuer’s outstanding voting stock. ICON’s Articles of Association require that only 3 members be present at a shareholder meeting to constitute a quorum. This quorum requirement is in accordance with Irish law and generally accepted business practices in Ireland. Item 11. Quantitative and Qualitative Disclosures about Market Risk Qualitative Disclosure of Market Risk. The principal market risks (i.e. risk of loss arising from adverse changes in market rates and prices) to which we are exposed are: • • • Interest rate changes on short term investments (available for sale) in the form of floating rate notes and medium term minimum “AA” rated corporate securities, and Interest rate risk on variable rate debt. Foreign currency risk on non-U.S. dollar denominated cash and non-U.S. dollar denominated debt. We use derivative financial instruments solely to hedge exposure to these market risks and we do not enter into these instruments for trading or speculative purposes. The Company had no interest rate instruments or derivatives as at December 31, 2008. Our primary foreign currency exchange risk relates to movements in rates between the U.S. dollar, Sterling and the Euro. At December 31, 2008, we had cash denominated in non-U.S. dollar denominated currencies. In order to reduce the foreign currency exchange risk, we may enter into certain derivative instruments to reduce our exposure to adverse changes in exchange rates. At December 31, 2008, we held no foreign exchange forward contracts. Quantitative disclosure of Market Risk. The analysis below presents the sensitivity of the market value, or fair value of our financial instruments to selected changes in market rates and prices. The changes chosen represent our view of changes that are reasonable over a one year period. The hypothetical changes in fair value are estimated based on the same methodology used by the third party financial institutions to calculate the fair value of the original instruments, keeping all variables constant except the relevant exchange rate, as the case may be, which has been adjusted to reflect the hypothetical change. Fair value estimates by their nature are subjective and involve uncertainties and matters of significant judgment and therefore cannot be determined precisely. 48 Foreign Currency Exchange Risk The sensitivity analysis below represents the hypothetical change in fair value based on an immediate 10% movement in the exchange rates. Non-U.S. Dollar denominated cash . . . . Non-U.S. Dollar denominated Fair value at December 31, 2008 (in thousands) $ 13,917 short term debt . . . . . . . . . . . . . . . . $ 40,193 Interest Rate Risk Fair value Change +10% movement in foreign exchange rate (in thousands) Fair value Change -10% movement in foreign exchange rate (in thousands) $ 1,392 $ 4,019 $ (1,392) $ (4,019) The sensitivity analysis below represents the hypothetical change in our interest income/(expense) based on an immediate 1% movement in market interest rates. Interest Income/(Expense) for the year ended December 31, 2008 (in thousands) Interest Income/(Expense) Change 1% increase in market interest rate (in thousands) Interest Income/(Expense) Change 1% decrease in market interest rate (in thousands) Interest Income . . . . . . . . . . . . . . . Interest Expense . . . . . . . . . . . . . . $ 2,880 $ (4,102) $ 3,882 $ (5,156) $ 1,860 $ (3,048) Item 12. Description of Securities Other than Equity Securities Not applicable. 49 Item 13. Defaults, Dividend Arrearages and Delinquencies None. PART II Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds We hereby incorporate by reference the description of the amendment to our Memorandum and Articles of Association described under the heading “Memorandum and Articles of Association” from Item 10 of this Form 20-F. Item 15. Controls and Procedures (a) Evaluation of disclosure controls and procedures An evaluation was carried out under the supervision and with the participation of the Company’s management, including the Chief Executive Officer (CEO) and the Chief Financial Officer (CFO), of the effectiveness of our disclosure controls and procedures as at December 31, 2008. Based on that evaluation, the CEO and CFO have concluded that the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed by the Company in reports that it files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms. (b) Management’s Annual Report Reference is made to page 53 of this Form 20-F. (c) Report of Independent Registered Public Accounting Firm Reference is made to page 55 of this Form 20-F. (d) Changes in internal controls There were no changes in our internal controls over financial reporting that occurred during the period covered by this Form 20-F that have materially affected or are reasonably likely to materially affect our internal controls over financial reporting. Item 16. Reserved. Item 16A. Audit Committee Financial Expert Mr. Thomas Lynch acts as the Audit Committee financial expert serving on our Audit Committee and Board of Directors. Mr. Lynch is an independent Board member and serves as one of our non-executive directors. Item 16B. Code of Ethics Our Board of Directors adopted its code of ethics in 2003, which applies to the Chief Executive Officer, the Chief Financial Officer and any persons performing similar functions, if any, of the Company. There are no material modifications to, or waivers from, the provisions of such code, which are required to be disclosed. This code is available on our website at the following address: http://www.iconplc.com 50 Item 16C. Principal Accountant Fees and Services Our principal accountants for the years ended December 31, 2008 and December 31, 2007, were KPMG. The table below summarizes the fees for professional services rendered by KPMG for the audit of our annual financial statements for the years ended December 31, 2008, and December 31, 2007, and fees billed for other services rendered by KPMG. Audit fees (1) . . . . . . . . . . . . . . . . . . . . . . . . Audit related fees (2) . . . . . . . . . . . . . . . . . . . . Tax fees (3) . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 month period ending December 31, 2007 (in thousands) $2,075 418 429 $2,922 71% 14% 15% 100% 12 month period ending December 31, 2008 (in thousands) $1,835 403 1,171 $3,409 54% 12% 34% 100% (1) Audit fees include annual audit fees for ICON plc and its subsidiaries. (2) Audit related fees principally consisted of fees for financial due diligence services and fees for audit of financial statements of employee bene- fit plans. (3) Tax fees are fees for tax compliance and tax consultation services. The Audit Committee pre-approves on an annual basis the audit and non-audit services provided to ICON plc by its auditors. Such annual pre-approval is given with respect to particular services. The Audit Committee, on a case-by-case basis, may approve additional services not covered by the annual pre-approval, as the need for such services arises. Item 16D. Exemptions from the Listing Standards for Audit Committees Not applicable. Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers Not applicable. Item 17. Financial Statements See item 18. Item 18. Financial Statements PART III Reference is made to pages 54 to 93 of this Form 20-F. 51 Item 19. Financial Statements and Exhibits Financial statements of ICON plc and subsidiaries Management’s Report on Internal Control over Financial Reporting Report of Independent Registered Public Accounting Firm. Consolidated Balance Sheets as at December 31, 2007 and 2008 Consolidated Statements of Operations for the years ended December 31, 2006, December 31, 2007 and December 31, 2008. Consolidated Statements of Shareholders’ Equity and Comprehensive Income for the years ended December 31, 2006, December 31, 2007 and December 31, 2008 Consolidated Statements of Cash Flows for the years ended December 31, 2006, December 31, 2007 and December 31, 2008. Notes to the Consolidated Financial Statements. Exhibits of ICON plc and subsidiaries Amended Memorandum and Articles of Association (incorporated by reference to Exhibits 3.1 and 3.2 to the Form 6-k (File No. 333-08704) filed on December 5, 2008). ICON plc Share Option Plan 2003, as updated on October 26, 2006, for the 2006 bonus issue, further updated on February 5, 2007 and updated on July 21, 2008, for the 2008 bonus issue (incorporated by reference to Exhibit 4.1 to the Form S-8 (File No. 333-152802) filed on August 6, 2008). ICON plc Consultants Share Option Plan 2008 (incorporated by reference to Exhibit 4.2 to the Form S-8 (File No. 333-152802) filed on August 6, 2008). ICON plc Employee Share Option Plan 2008 (incorporated by reference to Exhibit 4.3 to the Form S-8 (File No. 333-152802) filed on August 6, 2008). ICON plc Employees Restricted Share Unit Plan (incorporated by reference to Exhibit 4.4 to the Form S-8 (File No. 333-152802) filed on August 6, 2008). Significant subsidiaries (Incorporated by reference in Item 4). Office Space Lease, dated September 25, 1998, between ICON Clinical Research, Inc. and O’Neill Lansdale Properties, L.P. Amended and Restated Office Space Lease, dated January 1, 2001, between ICON Clinical Research and 212 Church Associates, L.P. Amendment Number 1 to the Amended and Restated Office Space Lease, between ICON Clinical Research , Inc. and 212 C Associates, L.P. Amendment Number 2 to the Amended and Restated Office Space Lease, dated January 11, 2005, between ICON Clinical Research , Inc. and 212 C Associates, L.P. Agreement of Lease, dated August 13, 2001, between ICON Clinical Research (UK) Limited, ICON plc and Capital Business Parks Globeside Limited. Agreement of Lease, dated November 29, 2002, between ICON Laboratories, Inc. and MSM Reality Co. LLC, Davrick, LLC and Sholom Blau Co. LLC (together, the “Landlord”). Highwoods Properties Office Lease, dated February 17, 2003, between ICON Clinical Research, Inc. and Highwoods Realty Limited Partnership. Section 302 certifications. Section 906 certifications. Consent of KPMG, Independent Registered Public Accounting Firm 52 MANAGEMENT’S REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934. The Company’s internal control over financial reporting is a process designed by, or under the supervision of, the Company’s executive and financial officers and effected by the Company’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external reporting purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorization of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. Because of the inherent limitation due to, for example, the potential for human error or circumvention of control, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2008. In making this assessment, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control – Integrated Framework. Based upon the assessment performed, we determined that, as of December 31, 2008, the Company’s internal control over financial reporting was effective. In addition, there have been no changes in the Company’s internal control over financial reporting during 2008 that have materially affected, or are reasonably likely to affect materially, the Group’s internal control over financial reporting KPMG, which has audited the consolidated financial statements of the Company for the year ended December 31, 2008, has also audited the effectiveness of the Company’s internal control over financial reporting under Auditing Standard No. 5 of the Public Company Accounting Oversight Board (United States). 53 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Directors and Shareholders of ICON plc We have audited the accompanying consolidated balance sheets of ICON plc and subsidiaries (“the Company”) as of December 31, 2008 and 2007 and the related consolidated statements of operations, shareholders’ equity and comprehensive income, and cash flows for each of the years in the three-year period ended December 31, 2008. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of ICON plc and subsidiaries as of December 31, 2008 and December 31, 2007 and the results of their operations and their cash flows for each of the years in the three-year period ended December 31, 2008, in conformity with U.S. generally accepted accounting principles. As described in Note 2 to the consolidated financial statements, the Company adopted the provisions of FASB Interpretation No. 48 Accounting for Uncertain Income Taxes, as of January 1, 2007. As described in Note 2 to the consolidated financial statements, effective January 1, 2006, the Company changed its method of accounting for share- based compensation upon adoption of Statement of Accounting Standard No. 123R Share Based Payments. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), ICON plc’s internal control over financial reporting as of December 31, 2008, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) and our report dated February 19, 2009, expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting. KPMG Dublin, Ireland February 19, 2009 54 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Directors and Shareholders of ICON plc We have audited ICON plc’s internal control over financial reporting as of December 31, 2008, based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). ICON plc’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying report. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion. A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. In our opinion, ICON plc maintained, in all material respects, effective internal control over financial reporting as of December 31, 2008, based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of ICON plc as of December 31, 2008 and 2007 and the related consolidated statements of operations, shareholders’ equity and comprehensive income, and cash flows for each of the years in the three-year period ended December 31, 2008 and our report dated February 19, 2009 expressed an unqualified opinion on those consolidated financial statements. KPMG Dublin, Ireland February 19, 2009 55 ICON plc CONSOLIDATED BALANCE SHEETS December 31, 2007 December 31, 2008 (in thousands) ASSETS Current Assets: Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Short term investments - available for sale (Note 3) Accounts receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unbilled revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other receivables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Deferred tax asset (Note 13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Prepayments and other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Income taxes receivable (Note 13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other Assets: Property, plant and equipment, net (Note 6) . . . . . . . . . . . . . . . . . . . . . . . . Goodwill (Note 4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Non-current other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Non-current income taxes receivable (Note 13) . . . . . . . . . . . . . . . . . . . . . . Non-current deferred tax asset (Note 13) . . . . . . . . . . . . . . . . . . . . . . . . . . . Intangible assets (Note 5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total Assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 76,881 41,752 129,865 144,661 6,171 4,919 16,449 2,448 423,146 133,426 123,879 2,140 3,049 5,703 1,795 $ 693,138 LIABILITIES AND SHAREHOLDERS’ EQUITY Current Liabilities: Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Payments on account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other liabilities (Note 7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Deferred tax liability (Note 13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bank credit lines and loan facilities (Note 8) . . . . . . . . . . . . . . . . . . . . . . . . Income taxes payable (Note 13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 13,459 96,553 70,743 398 43,767 4,955 229,875 Other Liabilities: Long term government grants (Note 11) . . . . . . . . . . . . . . . . . . . . . . . . . . Long term finance leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Non-current income taxes payable (Note 13) . . . . . . . . . . . . . . . . . . . . . . . . Non-current deferred tax liability (Note 13) . . . . . . . . . . . . . . . . . . . . . . . . . Non-current other liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Non-current bank credit lines and facilities (Note 8) . . . . . . . . . . . . . . . . . . . Minority interest (Note 4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,179 49 13,906 5,966 1,394 51,062 1,307 Shareholders’ Equity: Ordinary shares, par value 6 euro cents per share; 100,000,000 shares authorized, (Note 12) 57,670,488 shares issued and outstanding at $ 58,378 42,726 210,535 141,727 11,196 5,609 24,332 5,776 500,279 171,748 169,344 2,179 4,840 8,271 10,624 $ 867,285 $ 17,505 121,935 130,223 1,356 40,193 3,110 314,322 1,386 470 15,949 12,196 1,410 65,186 — December 31, 2007 and 58,518,195 shares issued and outstanding at December 31, 2008*. . . . . . . . . . . . . . . . . . . . . . . . Additional paid-in capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accumulated other comprehensive income . . . . . . . . . . . . . . . . . . . . . . . . . Retained earnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total Shareholders’ Equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total Liabilities and Shareholders’ Equity . . . . . . . . . . . . . . . . . . . . . . . . . . . 4,843 143,639 31,828 208,090 388,400 $ 693,138 4,921 162,057 3,178 286,210 456,366 $ 867,285 * Comparative figures have been amended to reflect the Bonus Issues (Stock Splits) which took place with an effective date of October 13, 2006 and August 8, 2008 56 ICON plc CONSOLIDATED STATEMENTS OF OPERATIONS Year Ended December 31, 2006 2007 (in thousands, except share and per share data) 2008 Revenue: Gross revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reimbursable expenses . . . . . . . . . . . . . . . . . . . . . . . . . . Net revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 649,826 (194,229) 455,597 $ 867,473 (236,751) 630,722 $ 1,209,451 (344,203) 865,248 Costs and expenses: Direct costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selling, general and administrative . . . . . . . . . . . . . . . . . . . Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . Total costs and expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . Income from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . Interest income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Income before provision for income taxes . . . . . . . . . . . . . . . Provision for income taxes (Note 13) . . . . . . . . . . . . . . . . . . Minority interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256,263 136,569 14,949 407,781 47,816 3,765 (125) 51,456 (12,924) (228) 354,479 187,993 19,008 561,480 69,242 4,141 (1,403) 71,980 (15,830) (187) 489,238 248,778 27,728 765,744 99,504 2,881 (4,105) 98,280 (19,967) (193) Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 38,304 $ 55,963 $ 78,120 Net income per ordinary share: Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 0.68 Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 0.66 $ $ 0.97 $ 0.94 $ 1.34 1.30 Weighted average number of ordinary shares outstanding*: Basic (Note 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56,629,970 57,410,544 58,245,240 Diluted (Note 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57,726,668 59,495,928 60,221,587 * Comparative figures have been amended to reflect the Bonus Issues (Stock Splits) which took place with an effective date of October 13, 2006 and August 8, 2008 The accompanying notes are an integral part of these consolidated financial statements. 57 CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY AND COMPREHENSIVE INCOME (in thousands, except share and per share data) ICON plc Shares — — — Balance at December 31, 2005* . . . . . 56,072,368 Comprehensive Income: Net income . . . . . . . . . . . . . . . . . . . Currency translation adjustment . . . . . . Actuarial loss on defined benefit pension plan (net of nil tax) . . . . . . . . . . . . Total comprehensive income . . . . . . . . 963,336 Exercise of share options . . . . . . . . . . — Share based compensation expense . . . . — Share issue costs . . . . . . . . . . . . . . . . Tax benefit on exercise of options . . . . — Balance at December 31, 2006* . . . . . 57,035,704 Comprehensive Income: Net income . . . . . . . . . . . . . . . . . . . Currency translation adjustment (net of tax) . . . . . . . . . . . . . . . . . . . . Actuarial gain on defined benefit pension plan (net of nil taxation) . . . . . . . . . Total comprehensive income . . . . . . . . Exercise of share options . . . . . . . . . . Share based compensation expense . . . . — Share issue costs . . . . . . . . . . . . . . . . — Tax benefit on exercise of options . . . . Balance at December 31, 2007* . . . . . 57,670,488 634,784 — — — Accumulated Other Comprehensive Income Retained Earnings $ 3,409 $ 113,823 $ 241,558 Total — 11,482 38,304 38,304 11,482 — (376) (376) 49,410 6,679 4,066 (84) 1,109 $ 14,515 $ 152,127 $ 302,738 — — — — — — — — — 55,963 55,963 11,893 — 11,893 — 5,420 5,420 73,276 5,298 5,748 (126) 1,466 $ 31,828 $ 208,090 $ 388,400 — — — — — — — — Additional Paid-in Capital $ 119,611 Amount $ 4,715 — — — — — — 74 — — — $ 4,789 6,605 4,066 (84) 1,109 $ 131,307 — — — 54 — — $ 4,843 — — — 5,244 5,748 (126) 1,466 $ 143,639 58 CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY AND COMPREHENSIVE INCOME (in thousands, except share and per share data) ICON plc Shares Balance at December 31, 2007* . . . . . 57,670,488 Comprehensive Income: . . . . . . . . . . . Net income . . . . . . . . . . . . . . . . . . . Currency translation adjustment — (net of tax) . . . . . . . . . . . . . . . . . . — Actuarial gain on defined benefit — pension plan (net of nil taxation) . . . Total comprehensive income . . . . . . . . 847,707 Exercise of share options . . . . . . . . . . — Share based compensation expense . . . . — Share issue costs . . . . . . . . . . . . . . . . Tax benefit on exercise of options . . . . — Balance at December 31, 2008* . . . . . 58,518,195 Additional Paid-in Capital $ 143,639 Amount $ 4,843 — — — — — — 78 — — — $ 4,921 8,438 6,058 (138) 4,060 $ 162,057 Accumulated Other Comprehensive Income Retained Earnings $ 31,828 $ 208,090 $ 388,400 Total — 78,120 78,120 (27,606) — (27,606) — (1,044) (1,044) 49,470 8,516 6,058 (138) 4,060 $ 3,178 $ 286,210 $ 456,366 — — — — — — — — * Comparative figures have been amended to reflect the Bonus Issues (Stock Splits) which took place with an effective date of October 13, 2006 and August 8, 2008 The accompanying notes are an integral part of these consolidated financial statements. 59 CONSOLIDATED STATEMENTS OF CASH FLOWS ICON plc Cash flows from operating activities: Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adjustments to reconcile net income to net cash provided by operating activities: Loss on disposal of property, plant and equipment . . . . . . . . Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . Amortization of government grants . . . . . . . . . . . . . . . . . . Stock compensation expense . . . . . . . . . . . . . . . . . . . . . . Deferred taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Minority interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changes in assets and liabilities: Increase in accounts receivable . . . . . . . . . . . . . . . . . . . . . (Increase)/decrease in unbilled revenue . . . . . . . . . . . . . . . . . Decrease/(increase) in other receivables . . . . . . . . . . . . . . . . (Increase)/decrease in prepayments and other current assets . . . Increase in other non current assets . . . . . . . . . . . . . . . . . . Increase in payments on account . . . . . . . . . . . . . . . . . . . . Increase in other current liabilities . . . . . . . . . . . . . . . . . . . Increase in other non current liabilities . . . . . . . . . . . . . . . . Increase/(decrease) in income taxes payable . . . . . . . . . . . . . Increase in accounts payable . . . . . . . . . . . . . . . . . . . . . . . Net cash provided by operating activities . . . . . . . . . . . . . . Cash flows from investing activities: Purchase of property, plant and equipment . . . . . . . . . . . . . . Purchase of subsidiary undertakings and acquisition costs . . . . Deferred payments in respect of historical acquisitions . . . . . . Cash acquired with subsidiary undertaking . . . . . . . . . . . . . . Grant received . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sale of short term investments . . . . . . . . . . . . . . . . . . . . . Purchase of short term investments . . . . . . . . . . . . . . . . . . Net cash used in investing activities . . . . . . . . . . . . . . . . . Cash flows from financing activities: Drawdown of credit lines and facilities . . . . . . . . . . . . . . . . Repayment of credit lines and facilities . . . . . . . . . . . . . . . . Proceeds from the exercise of share options . . . . . . . . . . . . . Share issuance costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tax benefit from the exercise of share options . . . . . . . . . . . Bank overdraft acquired with subsidiary undertakings . . . . . . . Repayment of other liabilities and finance lease obligations . . Net cash provided by financing activities . . . . . . . . . . . . . . Effect of exchange rate movements on cash . . . . . . . . . . . . . . Net increase/(decrease) in cash and cash equivalents . . . . . Cash and cash equivalents at beginning of year . . . . . . . . . . . . Cash and cash equivalents at end of year . . . . . . . . . . . . . . 60 Year Ended December 31, 2006 Year Ended December 31, 2007 Year Ended December 31, 2008 $ 38,304 $ 55,963 $ 78,120 186 14,949 (114) 4,066 (1,887) 228 (32,893) (24,178) 5,089 (2,477) — 35,605 10,699 — 1,532 1,343 50,452 (31,516) (7,017) (96) 341 — 3,008 (20,021) (55,301) 112 — 6,679 (84) 1,109 — (114) 7,702 677 3,530 59,509 396 19,008 (117) 5,748 (1,177) 187 (11,390) (52,231) 2,275 502 (2,140) 4,220 14,403 1,394 3,582 2,343 42,966 (75,391) (41,150) — — — 14,824 (16,753) (118,470) 94,829 (5,000) 5,298 (126) 1,466 (2,400) (109) 93,958 (4,612) 13,842 63,039 254 27,728 (126) 6,058 2,909 193 (83,816) 2,168 (10,175) (9,444) (39) 26,404 41,849 17 (3,968) 3,150 81,282 (67,882) (49,540) — 549 400 14,026 (15,000) (117,447) 58,925 (48,927) 8,516 (138) 4,060 — (99) 22,337 (4,675) (18,503) 76,881 $ 63,039 $ 76,881 $ 58,378 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS 1. Description of business ICON plc and its subsidiaries (“the Company” or “ICON”) is a contract research organization (“CRO”), providing outsourced development services on a global basis to the pharmaceutical, biotechnology and medical device industries. The Company specializes in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies. The Company’s primary approach is to use dedicated teams to achieve optimum results, but the Company can implement a range of resourcing models to suit client requirements. In a highly fragmented industry, we are one of a select group of companies with the capability and expertise to conduct clinical trials in all major therapeutic areas on a global basis. At December 31, 2008, the Company had 6,975 employees, in 71 locations, in 38 countries, providing Phase I - IV Clinical Trial Management, Drug Development Support Services, Data Management and Biostatistics and Central Laboratory and Imaging Services. The Company has the operational flexibility to provide development services on a stand-alone basis or as part of an integrated “full service” solution. Headquartered in Dublin, Ireland, we began operations in 1990 and have expanded our business through internal growth and strategic acquisitions. For the year ended December 31, 2008, we derived approximately 43.8%, 47.8% and 8.4% of our net revenue in the United States, Europe and Rest of World, respectively. On July 21, 2008, the Company’s shareholders approved a bonus issue of ordinary shares (the “Bonus Issue”) to shareholders of record as of the close of business on August 8, 2008 (the “Record Date”). The Bonus Issue provided for each shareholder to receive one bonus ordinary share for each ordinary share held as of the Record Date, effecting the equivalent of a 2-for-1 stock split. The Bonus shares were issued on August 11, 2008, to Ordinary Shareholders and on August 12, 2008, to holders of American Depositary Shares (“ADSs”). The trading price of ICON’s ADSs was adjusted on NASDAQ to effect the Bonus Issue prior to the opening of trading on August 13, 2008. All outstanding ordinary share amounts referenced in the consolidated financial statements and the notes thereto have been retrospectively restated to give effect to the Bonus Issue as if it had occurred as of the date referenced. On September 29, 2006, ICON’s shareholders approved a bonus issue of ordinary shares (the “Bonus Issue”) to shareholders of record as of the close of business on October 13, 2006 (the “Record Date”). The Bonus Issue provided for each shareholder to receive one bonus ordinary share for each ordinary share held as of the Record Date, effecting the equivalent of a 2-for-1 stock split. The Bonus shares were issued on October 16, 2006, to Ordinary Shareholders and on October 23, 2006, to holders of American Depositary Shares (“ADSs”). The trading price of ICON’s ADSs was adjusted on NASDAQ to effect the Bonus Issue prior to the opening of trading on October 24, 2006. All outstanding ordinary share amounts referenced in the consolidated financial statements and the notes thereto have been retrospectively restated to give effect to the Bonus Issue as if it had occurred as of the date referenced. 2. Significant Accounting Policies The accounting policies noted below were applied in the preparation of the accompanying financial statements of the Company and are in conformity with accounting principles generally accepted in the United States. (a) Basis of consolidation The consolidated financial statements include the financial statements of the Company and all of its subsidiaries. All significant intercompany profits, transactions and account balances have been eliminated. The results of subsidiary undertakings acquired in the period are included in the consolidated statement of operations from the date of acquisition. (b) Use of estimates The preparation of financial statements in conformity with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and 61 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reported period. Actual results could differ from those estimates. (c) Revenue recognition The Company primarily earns revenues by providing a number of different services to its customers. These services include clinical trials management, biometric activities, consulting, imaging and laboratory services. Contracts range in duration from a number of months to several years. Revenue for services, as rendered, is recognized only after persuasive evidence of an arrangement exists, the sales price is fixed or determinable and collectibility is reasonably assured. Clinical trials management revenue is recognized on a proportional performance method based on the relationship between hours incurred and the total estimated hours of the trial. The input (effort expended) method has been used to measure progress towards completion as there is a direct relationship between input and productivity. Contract costs equate to the product of labor hours incurred and compensation rates. Contract revenue is the product of the aggregated labor hours required to complete the specified contract tasks at the agreed contract rates. The Company regularly reviews the estimate of total contract time to ensure such estimates remain appropriate taking into account actual contract stage of completion, remaining time to complete and any identified changes to the contract scope. Remaining time to complete depends on the specific contract tasks and the complexity of the contract and can include geographical site selection and initiation, patient enrolment, patient testing and level of results analysis required. While the Company may routinely adjust time estimates, the Company’s estimates and assumptions historically have been accurate in all material respects in the aggregate. Biometrics revenue is recognised on a fee-for-service method as each unit of data is prepared on the basis of the number of units completed in a period as a percentage of the total number of contracted units. Imaging revenue is recognised on a fee-for-service basis recognizing revenue for each image completed. Consulting revenue is recognised on a fee-for-service basis as each hour of the related service is performed. Laboratory service revenue is recognised on a fee- for-service basis. The Company accounts for laboratory service contracts as multiple element arrangements, with contractual elements comprising laboratory kits and laboratory testing, each of which can be sold separately. Fair values for contractual elements are determined by reference to objective and reliable evidence of their fair values. Revenues for contractual elements are recognised on the basis of the number of deliverable units completed in the period. Contracts generally contain provisions for renegotiation in the event of changes in the scope, nature, duration, or volume of services of the contract. Renegotiated amounts are recognised as revenue by revision to the total contract value arising as a result of an authorised customer change order. The difference between the amount of revenue recognised and the amount billed on a particular contract is included in the balance sheet as unbilled revenue. Normally, amounts become billable upon the achievement of certain milestones, for example, target patient enrolment rates, clinical testing sites initiated or case report forms completed. Once the milestone target is reached, amounts become billable in accordance with pre-agreed payment schedules included in the contract or on submission of appropriate billing detail. Such cash payments are not representative of revenue earned on the contract as revenues are recognised over the period in which the specified contractual obligations are fulfilled. Amounts included in unbilled revenue are expected to be collected within one year and are included within current assets. Advance billings to customers, for which revenue has not been recognised, are recognised as payments on account within current liabilities. In the event of contract termination, if the value of work performed and recognised as revenue is greater than aggregate milestone billings at the date of termination, cancellation clauses ensure that the Company is paid for all work performed to the termination date. (d) Reimbursable expenses Reimbursable expenses comprise investigator payments and certain other costs which are reimbursed by clients under terms specific to each contract and are deducted from gross revenue in arriving at net revenue. Investigator 62 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) payments are accrued based on patient enrollment over the life of the contract. Investigator payments are made based on predetermined contractual arrangements, which may differ from the accrual of the expense. Payments to investigators in excess of the accrued expense are classified as prepaid expenses and accrued expense in excess of amounts paid are classified as accounts payable. (e) Direct costs Direct costs consist of compensation and associated employee benefits for project-related employees, other direct project-related costs and share based compensation. (f) Advertising costs All costs associated with advertising and promotion are expensed as incurred. The advertising and promotion expense was U.S.$2,687,000 and US$3,612,000 for the years ended December 31, 2006 and 2007 respectively. For the year ended December 31, 2008, these costs amounted to U.S.$3,467,000. (g) Foreign currencies and translation of subsidiaries The Company’s financial statements are prepared in United States dollars. Transactions in currencies other than United States dollars are recorded at the rate ruling at the date of the transactions. Monetary assets and liabilities denominated in currencies other than United States dollars are translated into United States dollars at exchange rates prevailing at the balance sheet date. Adjustments resulting from these translations are charged or credited to income. For the years ended December 31, 2006 and 2007 the amounts charged to income amounted to, U.S.$ 1,538,000 and U.S. $6,266,000 respectively. For the year ended December 31, 2008, amounts credited to income amounted to U.S. $2,255,000. The financial statements of subsidiaries with other functional currencies are translated at period end rates for the balance sheet and average rates for the income statement. Translation gains and losses arising are reported as a movement on accumulated other comprehensive income. (h) Disclosure about fair value of financial instruments The following methods and assumptions were used to estimate the fair value of each material class of financial instrument: Cash, cash equivalents, unbilled revenue, other receivables, short term investments, prepayments and other current assets, accounts receivable, accounts payable, investigator payments, payments received on account, accrued liabilities, accrued bonuses, bank overdraft and taxes payable have carrying amounts that approximate fair value due to the short term maturities of these instruments. Long-term debt and other liabilities carrying amounts approximate fair value based on net present value of estimated future cash flows. (i) Leased Assets Costs in respect of operating leases are charged to the statement of operations on a straight line basis over the lease term. Assets acquired under capital finance leases are included in the balance sheet at the present value of the future minimum lease payments and are depreciated over the shorter of the lease term and their remaining useful lives. The corresponding liabilities are recorded in the balance sheet and the interest element of the capital lease rental is charged to interest expense. (j) Goodwill and Impairment Goodwill represents the excess of the cost of acquired entities over the net amounts assigned to assets acquired and liabilities assumed. Goodwill primarily comprises acquired workforce in place which does not qualify for recognition as an asset apart from goodwill. Goodwill is stated net of any provision for impairment. The Company tests good 63 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) will annually for any impairments or whenever events occur which may indicate impairment. The first step is to compare the carrying amount of the reporting unit’s assets to the fair value of the reporting unit. If the carrying amount exceeds the fair value then a second step is completed which involves the fair value of the reporting unit being allocated to each asset and liability with the excess being implied goodwill. The impairment loss is the amount by which the recorded goodwill exceeds the implied goodwill. No impairment was recognized as a result of the impairment testing carried out as at December 31, 2006, December 31, 2007 and December 31, 2008. (k) Intangible assets Intangible assets are amortized on a straight line basis over their estimated useful life. (l) Cash and cash equivalents Cash and cash equivalents include cash and highly liquid investments with initial maturities of three months or less and are stated at cost, which approximates market value. (m) Short term investments - available for sale The Company has classified short-term investments as available for sale in accordance with the terms of FASB Statement No. 115 Accounting for Certain Investments in Debt and Equity Securities (“SFAS No. 115”). Realized gains and losses are determined using specific identification. The investments are reported at fair value, with unrealized gains or losses reported in a separate component of shareholders’ equity. Any differences between the cost and fair value of the investments are represented by accrued interest. (n) Inventory Inventory is valued at the lower of cost and net market value and after provisions for obsolescence. Cost of raw materials comprises the purchase price and attributable costs, less trade discounts. As at the year ended December 31, 2008, the carrying value of inventory, included within prepayments and other current assets on the balance sheet, was U.S.$3.4 million (2007: U.S.$2.6 million). (o) Property, plant and equipment Property, plant and equipment are stated at cost less accumulated depreciation. Depreciation of property, plant and equipment is computed using the straight line method based on the estimated useful lives of the assets as listed below: Building . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Office furniture and fixtures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Laboratory equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Motor vehicles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Computer equipment and software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Years 40 8 5 5 4-8 Leasehold improvements are amortized using the straight-line method over the estimated useful life of the asset or the lease term, whichever is shorter. (p) Income taxes The Company applies FASB Statement No. 109, Accounting for Income Taxes (“SFAS No.109”), which requires the asset and liability method of accounting for income taxes. Under the asset and liability method of SFAS No. 109, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which these temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the 64 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) enactment date. The Company adopted Financial Interpretation Note No. 48 Accounting for uncertainty in Income taxes (FIN 48”) with effect from January 1, 2007. FIN 48 requires that the Company recognizes the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement when considering uncertain tax positions. (q) Government grants Government grants received relating to capital expenditure are shown as deferred income and credited to income on a basis consistent with the depreciation policy of the relevant assets. Grants relating to categories of operating expenditures are credited to income in the period in which the expenditure to which they relate is charged. Under the grant agreements amounts received may become repayable in full should certain circumstances specified within the grant agreements occur, including downsizing by the Company, disposing of the related assets, ceasing to carry on its business or the appointment of a receiver over any of its assets. The Company has not recognized any loss contingency having assessed as remote the likelihood of these events arising. (r) Pension costs The Company contributes to defined contribution plans covering all eligible employees. The Company contributes to these plans based upon various fixed percentages of employee compensation and such contributions are expensed as incurred. The Company operates, through a subsidiary, a defined benefit plan for certain of its United Kingdom employees. The Company accounts for the costs of this plan using actuarial models required by FASB Statement No. 87, Employers Accounting for Pensions (“SFAS No. 87) and the plan is presented in accordance with the requirements of FASB Statement No. 158 Employers’ Accounting for Defined Benefit Pensions and Other Post-retirement Plans (“SFAS No. 158”). (s) Net income per ordinary share Basic net income per ordinary share has been computed by dividing net income available to ordinary shareholders by the weighted average number of ordinary shares outstanding during the period. Diluted net income per ordinary share is computed by adjusting the weighted average number of ordinary shares outstanding during the period for all potentially dilutive ordinary shares outstanding during the period and adjusting net income for any changes in income or loss that would result from the conversion of such potential ordinary shares. There is no difference in net income used for basic and diluted net income per ordinary share. The reconciliation of the number of shares used in the computation of basic and diluted net income per ordinary share is as follows: 2006 Year Ended December 31, 2007 2008 Weighted average number of ordinary shares outstanding for basic net income per ordinary share . . . . . . . . . . . . . . . . . . . . Effect of dilutive share options outstanding . . . . . . . . . . . . . . . . 56,629,970 1,096,698 57,410,544 2,085,384 58,245,240 1,976,347 Weighted average number of ordinary shares outstanding for diluted net income per ordinary share . . . . . . . . . . . . . . . . 57,726,668 59,495,928 60,221,587 (t) Share-based compensation The Company accounts for its share options in accordance with the provisions of FASB Statement No. 123R Share Based Payment (“SFAS 123R”). SFAS 123R requires that all share based payments to employees, including stock options granted, be recognized in the financial statements based on their grant date fair values over the requisite service period. The Company adopted SFAS 123R with effect from January 1, 2006, with the Black-Scholes method 65 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) of valuation being used to calculate the fair value of options granted. The Company adopted SFAS 123R using the modified-prospective transition method. Under that transition method compensation cost includes; (a) compensation cost for all share-based payments granted prior to, but not yet vested as of, January 1, 2006, based on grant date fair value estimated in accordance with the original provisions of SFAS 123 and (b) compensation cost for all share based payments granted subsequent to January 1, 2006, based on grant date fair values estimated in accordance with the provisions of SFAS 123R and the estimated number of awards that are expected to vest. Results for periods prior to the adoption of SFAS 123R have not been restated. (u) Impairment of long-lived assets Long lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less selling costs. (v) Reclassifications Certain amounts in the consolidated financial statements have been reclassified where necessary to conform to the current year presentation. 3. Short term investments - available for sale The Company has classified its entire investment portfolio comprising floating rate and medium term minimum “AA” rated corporate securities, as available for sale. The investments are reported at fair value, with unrealized gains or losses reported in a separate component of shareholders’ equity. In the years ended December 31, 2006, December 31, 2007 and December 31, 2008, no unrealized gains or losses arose. Any differences between the cost and fair value of the investments are represented by accrued interest. 4. Goodwill December 31, 2007 December 31, 2008 (in thousands) Opening Goodwill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Arising during the year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foreign exchange movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 78,717 42,081 3,081 $ 123,879 55,674 (10,209) Closing Goodwill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 123,879 $ 169,344 The distribution of goodwill by business segment was as follows: December 31, 2007 December 31, 2008 Central laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 (in thousands) — $ $ 123,879 $ 123,879 — 169,344 $ 169,344 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) (a) Acquisition of Healthcare Discoveries Inc. On February 11, 2008, the Company acquired 100% of the common stock of Healthcare Discoveries Inc., for an initial cash consideration of $10.9 million, excluding costs of acquisition. Healthcare Discoveries, located in San Antonio, Texas, is engaged in the provision of Phase I clinical trial management services. Certain performance milestones were built into the acquisition agreement requiring payment of additional consideration of up to $10.0 million if these milestones were achieved during the year ended December 31, 2008. No amounts have been accrued at December 31, 2008, as the milestones have not been achieved. The acquisition of Healthcare Discoveries has been accounted for as a business combination in accordance with FASB Statement No. 141 Business Combinations (“SFAS 141”). The following table summarises the fair values of the assets acquired and the liabilities assumed at the date of acquisition. Property, plant and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Goodwill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . February, 11 2008 (in thousands) $ 327 2,890 9,995 5 575 (1,951) Purchase price . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 11,841 Goodwill represents the acquisition of an established workforce with experience in the provision of Phase I clinical trial management services to pharmaceutical and biotechnology companies. The proforma effect of the Healthcare Discoveries acquisition if completed on January 1, 2007, would have resulted in net revenue, net income and earnings per share for the fiscal years ended December 31, 2007 and 2008 as follows: Year Ended December 31, 2007 2008 (in thousands) Net revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Basic earnings per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diluted earnings per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 638,706 $ 55,375 0.96 $ 0.93 $ $ 865,723 $ 77,508 1.33 $ 1.29 $ (b) Acquisition of Prevalere Life Sciences Inc. On November 14, 2008, the Company acquired 100% of the common stock of Prevalere Life Sciences Inc. (“Prevalere”), for an initial cash consideration of $36.8 million, excluding costs of acquisition. Prevalere, located in Whitesboro, New York, is a leading provider of bioanalytical and immunoassay services to pharmaceutical and biotechnology companies. Certain performance milestones were built into the acquisition agreement requiring potential additional consideration of up to $8.2 million if these milestones are achieved during the years ended December 31, 2008 and 2009. Additional consideration of $5.0 million has been accrued at December 31, 2008, in respect of the milestones for the year ended December 31, 2008. No amounts have been accrued for additional consideration potentially payable in respect of the milestones for the year ended December 31, 2009. 67 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The acquisition of Prevalere has been accounted for as a business combination in accordance with FASB Statement No. 141 Business Combinations (“SFAS 141”). The following table summarises the fair values of the assets acquired and the liabilities assumed at the date of acquisition. Property, plant and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Goodwill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . November 14, 2008 (in thousands) $ 2,614 7,375 29,086 544 5,833 (2,827) Purchase price . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 42,625 Goodwill represents the acquisition of an established workforce with experience in the provision of bioanalytical and immunoassay services to pharmaceutical and biotechnology companies and allows ICON to participate in a growing market for these services. The proforma effect of the Prevalere acquisition if completed on January 1, 2007, would have resulted in net revenue, net income and earnings per share for the fiscal years ended December 31, 2007 and 2008 as follows: Year Ended December 31, 2008 2007 (in thousands) Net revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Basic earnings per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diluted earnings per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 641,116 $ 57,894 1.01 $ 0.97 $ $ 879,940 $ 83,919 1.44 $ 1.39 $ (c) Acquisition of remaining 30% interest in Beacon Biosciences Inc. On July 1, 2004, the Company acquired 70% of the common stock of Beacon Biosciences Inc. (“Beacon”), a leading specialist CRO, which provides a range of medical imaging services to the pharmaceutical, biotechnology and medical device industries, for an initial cash consideration of $9.9 million, excluding costs of acquisition. On December 31, 2008, the remaining 30% of the common stock was acquired by the Company for $17.4 million, excluding costs of acquisition. Certain performance milestones were built into the acquisition agreement for the remaining 30% of Beacon requiring potential additional consideration of up to $3.0 million if these milestones are achieved during the year ended December 31, 2009. At December 31, 2008, no amounts have been accrued in respect of the additional consideration payable. The acquisition of Beacon has been accounted for as a business combination in accordance with FASB Statement No. 141 Business Combinations (“SFAS 141”). The excess of consideration paid of $17.8 million, including costs of acquisition, over the carrying value of minority interest of $1.5 million, has been recorded as goodwill of $16.3 million., pending the Company’s finalization of the allocation of total consideration paid to acquired net tangible and intangible assets. This allocation will be completed in 2009. Goodwill represents the acquisition of the minority interest in the net assets of Beacon. 68 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The proforma effect of the Beacon acquisition, if completed on January 1, 2007, would have had no impact on net revenue. The profoma effect on net income and earnings per share for the fiscal years ended December 31, 2007 and 2008 would have been as follows: Year Ended December 31, 2008 2007 (in thousands) Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Basic earnings per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diluted earnings per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 56,150 0.98 $ 0.94 $ $ 78,313 1.34 $ 1.30 $ (d) Acquisition of DOCS International On July 12, 2007, the Company acquired 100% of the common stock of DOCS International (“DOCS”), a European based clinical research staffing organization, for a cash consideration of $40.6 million (A€ 29.5 million), excluding costs of acquisition. The acquisition of DOCS has been accounted for as a business combination in accordance with FASB Statement No. 141 Business Combinations (“SFAS 141”). The following table summarizes the fair values of the assets acquired and the liabilities assumed at the date of acquisition. Property, plant and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intangible asset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Goodwill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bank overdraft . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (in thousands) $ 984 2,035 42,395 (2,400) 7,646 (9,510) Purchase price . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 41,150 Goodwill represents the geographical presence afforded to the Company in the European staffing market and the acquisition of an established workforce in the eight countries in which DOCS International operates. 69 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The proforma effect of the DOCS acquisition if completed on January 1, 2006, would have resulted in net revenue, net income and earnings per share for the fiscal years ended December 31, 2006 and 2007 as follows: Net revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Basic earnings per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diluted earnings per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 478,622 $ 37,747 0.66 $ 0.65 $ $ 645,527 $ 56,245 0.98 $ 0.94 $ Year Ended December 31, 2007 2006 (in thousands) 5. Intangible Assets Cost December 31, 2007 December 31, 2008 (in thousands) Customer relationships acquired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Volunteer List acquired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foreign exchange movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accumulated amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foreign exchange movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $2,035 — 120 2,155 (345) (15) Net book value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $1,795 $11,095 1,325 (90) 12,330 (1,770) 64 $10,624 On February 11, 2008, the Company acquired 100% of the common stock of Healthcare Discoveries, a US based organization engaged in the provision of Phase I clinical trial management activities. The value of certain client relationships identified of U.S.$1.6 million are being amortised over periods ranging from approximately 2 to 9 years, the estimated periods of benefit. The value of certain volunteer lists identified of U.S.$1.3 million are being amortised over approximately 6 years, the estimated period of benefit. U.S. $498,000 has been amortised in the period since the date of acquisition. On November 14, 2008, the Company acquired 100% of the common stock of Prevalere Life Sciences, a US based organization engaged in the provision of bioanalytical and immunoassay services to pharmaceutical and biotechnology companies. The value of certain customer relationships identified of U.S.$7.4 million are being amortised over periods ranging from approximately 7 to 11 years, the estimated period of the benefit. U.S. $87,000 has been amortised in the period since the date of acquisition On July 12, 2007, the Company acquired 100% of the common stock of DOCS International (“DOCS”), a European based clinical research staffing organization. The value of certain customer relationships identified is being amortised over approximately 3 years, the estimated period of the benefit. U.S.$1,121,000 has been amortised in the period since the date of acquisition. 70 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) Future intangible asset amortization expense for the years ended December 31, 2009 to December 31, 2013 is as follows: 2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Year ended December 31 (in thousands) $2,074 1,484 1,140 1,140 1,140 $6,978 6. Property, Plant and Equipment, net Cost December 31, 2007 December 31, 2008 Land . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Building . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Computer equipment and software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Office furniture and fixtures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Laboratory equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Leasehold improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Motor vehicles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (in thousands) $ 4,102 70,260 95,689 41,140 11,180 5,753 78 3,963 85,099 117,278 53,775 24,822 5,983 75 Less accumulated depreciation and asset write off . . . . . . . . . . . . . . . . . . . . . . . 228,202 (94,776) Property, plant and equipment (net) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $133,426 290,995 (119,247) $171,748 Total cost at December 31, 2008, includes U.S.$1,054,000 (2007: U.S.$1,043,000), which relates to assets held under capital finance leases. Related accumulated depreciation amounted to U.S. $303,000 (2007: U.S.$869,000). The cost of assets under construction as at December 31, 2008, amounted to $nil million (2007: US$23.0 million). 71 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) 7. Other Liabilities Accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accrued salary and bonuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accrued social welfare costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lease accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Short term government grants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Short term finance leases (Note 15) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acquisition consideration payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8. Bank Credit Lines and Loan Facilities Current maturities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Non-current maturities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . December 31, 2007 December 31, 2008 (in thousands) $27,938 36,341 3,961 2,257 125 121 — $70,743 $ 44,440 51,647 8,757 2,508 144 327 22,400 $130,223 December 31, 2007 December 31, 2008 (in thousands) $43,767 51,062 $94,829 $ 40,193 65,186 $105,379 On July 9, 2007, ICON plc entered into a five year committed multi-currency facility agreement for A€ 35 million ($48.9 million) with The Governor and Company of the Bank of Ireland. Our obligations under the facility are secured by certain composite guarantees and indemnities and pledges in favor of the bank. The facility bears interest at an annual rate equal to the EURIBOR plus a margin. On July 10, 2007, the Company drew down A€ 29.5 million ($41.2 million) of the facility to fund the acquisition of DOCS International. On October 15, 2007, the remaining A€ 5.5 million ($7.7 million) of the facility was drawn down to fund expenditure on the expansion of the Company’s facility in Dublin, Republic of Ireland. On January 2, 2009, an additional four year committed credit facility was negotiated with The Governor and Company of the Bank of Ireland for $25 million. The facility bears interest at LIBOR plus a margin and is secured by certain composite guarantees, indemnities and pledges in favour of the bank. On October 17, 2007, an uncommitted credit facility was negotiated with Allied Irish Bank plc, for A€ 30 million ($41.9 million). Interest is calculated at the EUR interbank rate plus a margin. The facility is secured by the same composite guarantees and indemnities in place for the Bank of Ireland committed facility. The funds were used to refinance overdraft facilities in place to fund expenditure on the expansion of the Dublin facility. On January 8, 2008, the facility with Allied Irish Banks plc was increased to A€ 50 million ($69.9 million). On December 22, 2008, committed credit facilities were negotiated with Allied Irish Bank plc for $75 million. The facilities comprise a one year Euro facility of approximately A€ 20 million ($28.0 million), with the balance comprising a three year US dollar facility. The Euro facility bears interest at EURIBOR plus a margin and the US dollar facility bears interest at LIBOR plus a margin. Both facilities are secured by certain composite guarantees and pledges in favour of the bank. These facilities replace the uncommitted facilities negotiated on January 8, 2008. $28.4 million of these facilities were used to fund the acquisition of Prevalere with the remaining balance used to refinance the previous drawn uncommitted facilities. On February 4, 2008, an uncommitted credit facility was negotiated with Citibank N.A, for $30 million. Interest is calculated at the London Interbank Market rate plus a margin. $12.0 million of this facility was drawn down in February 2008 to fund the acquisition of Healthcare Discoveries. On September 30, 2008, the $12.0 million previously drawn was repaid in full. At December 31, 2008, this facility remained un-drawn and available to the Company. 72 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The average margin payable on the above mentioned facilities is 1.70 percent. The drawn facilities above are repayable as follows: 2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Year ended December 31 (in thousands) $ 40,193 — 52,954 — 12,232 $105,379 9. Employee Benefits Certain Company employees are eligible to participate in a defined contribution plan (the “Plan”). Participants in the Plan may elect to defer a portion of their pre-tax earnings into a pension plan, which is run by an independent party. The Company matches participant’s contributions typically at 6% of the participant’s annual compensation. Contributions to this plan are recorded, as an expense in the Consolidated Statement of Operations. Contributions for the years ended December 31, 2006, December 31, 2007 and December 31, 2008, were U.S.$4,837,000, U.S.$7,306,000 and U.S.$10,372,000 respectively. The Company’s United States operations maintain a retirement plan (the “U.S. Plan”) that qualifies as a deferred salary arrangement under Section 401(k) of the Internal Revenue Code. Participants in the U.S. Plan may elect to defer a portion of their pre-tax earnings, up to the Internal Revenue Service annual contribution limit. The Company matches 50% of each participant’s contributions, each participant can contribute up to 6% of their annual compensation. Contributions to this U.S. Plan are recorded, in the year contributed, as an expense in the Consolidated Statement of Operations. Contributions for the years ended December 31, 2006, December 31, 2007 and December 31, 2008, were U.S.$3,428,000, U.S.$4,488,000 and U.S.$4,499,000 respectively. One of the Company’s subsidiaries which was acquired during the 2003 fiscal year, Medeval Group Limited, operates a defined benefit pension plan in the United Kingdom for its employees. The plan is managed externally and the related pension costs and liabilities are assessed in accordance with the advice of a professionally qualified actuary. Plan assets at December 31, 2006, December 31, 2007 and December 31, 2008, consist of units held in independently administered funds. The pension costs of this plan are presented in the following tables in accordance with the requirements of SFAS No.158, Employers’ Accounting for Defined Pension and Other Postretirement Plans. The plan is no longer open to new entrants. Change in benefit obligation December 31, 2007 December 31, 2008 (in thousands) Benefit obligation at beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Service cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Interest cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plan participants’ contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benefits paid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Actuarial gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plan curtailments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foreign currency exchange rate changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 17,816 766 930 227 (50) (4,722) — 249 Benefit obligation at end of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 15,216 $ 15,216 437 854 207 (75) (1,968) (871) (3,686) $ 10,114 73 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) Change in plan assets December 31, 2007 December 31, 2008 (in thousands) Fair value of plan assets at beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . Actual return on plan assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Employer contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plan participants’ contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benefits paid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foreign currency exchange rate changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 13,092 1,582 457 227 (50) 162 Fair value of plan assets at end of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 15,470 $ 15,470 (1,858) 428 207 (75) (3,780) $ 10,392 None of the fair values of the assets above include any of the Company’s own financial instruments, or any property occupied by, or other assets used by, the Company. Funded status December 31, 2007 December 31, 2008 (in thousands) Projected benefit obligation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fair value of plan assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $(15,216) 15,470 $(10,114) 10,392 Funded status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unrecognized net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Current asset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Non-current asset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 254 — 254 — $ 278 — 278 — Components of net periodic benefit cost/(credit) December 31, 2006 December 31, 2007 December 31, 2008 Service cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Interest cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Expected return on plan assets . . . . . . . . . . . . . . . . . . . . . . . Plan curtailments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amortization of net loss/(gain) . . . . . . . . . . . . . . . . . . . . . . Net periodic benefit cost/(credit) . . . . . . . . . . . . . . . . . . . . . . $ 685 730 (593) — 15 $ 837 (in thousands) $ 766 930 (928) — 44 $ 812 $ 437 854 (1,063) (871) (89) $ (732) The estimated net gain and prior service cost for the defined benefit pension plan that will be amortized from accumulated other comprehensive income into net periodic benefit cost over the next year are U.S.$0.02 million and U.S.$nil respectively. Amounts included in other comprehensive income consist of: December 31, 2006 Actuarial loss/(gain) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Less actuarial loss/(gain) recognized in net periodic $ 391 December 31, 2007 (in thousands) $ (5,376) benefit cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (15) (44) Amounts recognized in other comprehensive income . . . . . . . . $ 376 $ (5,420) December 31, 2008 $ 955 89 $1,044 74 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) Amounts recognized in accumulated other comprehensive income that have not yet been recognized as components of net periodic benefit/cost December 31, 2006 December 31, 2007 December 31, 2008 Net actuarial loss/(gain) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total amount in accumulated other comprehensive income . . $2,220 $2,220 (in thousands) $(3,200) $(3,200) Accumulated other comprehensive income expected to be recognized as periodic benefit cost over the next financial year Net gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $(2,156) $(2,156) December 31, 2009 (in thousands) $ 22 $ 22 Weighted average assumptions to determine benefit obligation December 31, 2007 December 31, 2008 Discount rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rate of compensation increase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Expected rate of return on plan assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.8% 4.5% 7.1% 6.4% 4.2% 6.8% The assets of the scheme are invested in a global equity fixed index fund. The expected long-term rate of return on assets of 6.8% was calculated as the value of the fund after application of a market value reduction factor. The underlying asset split of the fund is shown below. Asset Category Equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bonds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Property . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cash/other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . December 31, 2007 December 31, 2008 63% 20% 12% 5% 100% 90% 10% —% —% 100% The assets of the scheme are invested in the Legal and General Global Equity Fixed Index Fund. The aim of this fund is to capture the returns on UK and overseas equity markets with a more even investment in UK and overseas equities than would be provided by reference to market capitalization or consensus weights. Although market fluctuations of investment return are smoothed through the declaration of annual bonuses, the investment objective is to provide payments which reflect the actual investment returns achieved by the scheme over the long run. The accumulated benefit obligation for the defined pension plans was $10.1 million at December 31, 2008 (December 31, 2007: $15.2 million; December 31, 2006: $17.8 million). With effect from July 1, 2003, the scheme was closed to new entrants. The Company expects to contribute $0.4 million to its pension fund in the year ending December 31, 2009. 75 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The following annual benefit payments, which reflect expected future service, as appropriate, are expected to be paid. Estimated future benefit payments (in thousands) 2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Years 2014 - 2018 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 15 44 44 73 73 $ 386 The expected cash flows are estimated figures based on the members expected to retire over the next 10 years assuming no early retirements plus an additional amount in respect of recent average withdrawal experience. At the present time it is not clear whether annuities will be purchased when members reach retirement or whether pensions will be paid each month out of scheme assets. The cash flows above have been estimated on the assumption that pensions will be paid monthly out of scheme assets. If annuities are purchased, then the expected benefit payments will be significantly different from those shown above. Overall Rate of Return At December 31, 2008, UK gilts were yielding around 3.9% per annum. This is often referred to as the risk free rate of return as UK gilts have a negligible risk of default and the income payments and capital on redemption are guaranteed by the UK Government. The long-term expected return on equities and property has been determined by setting appropriate risk premiums above the yield on UK gilts. A long term equity “risk-premium” of 3.1% per annum has been assumed, this being the expected long-term out-performance of equities over UK gilts. A long term property “risk-premium” of 2.6% per annum has been assumed, this being the expected long-term out-performance of property over UK gilts. The long-term expected return on bonds is determined by reference to UK long dated government and corporate bond yields at the balance sheet date. This represents the iboxx AA 15 year plus return. The long term expected return on cash is determined by reference to bank base rates at the balance sheet date. Applying the above expected long term rates of return to the asset distribution at December 31, 2008, gives rise to an expected overall rate of return of scheme assets of approximately 6.8% per annum. The expected long term rates of return on different asset classes over the long term are as follows: Asset Category Expected long-term return per annum Equities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bonds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Property . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.0% 4.8% 6.5% 2.0% 10. Share Options and Stock Compensation Charges The Company accounts for its share options in accordance with the provisions of SFAS No. 123R, Share Based Payment. SFAS 123R requires that all share based payments to employees, including stock options granted, be recognized in the financial statements based on their grant date fair values. The Company adopted SFAS 123R with effect from January 1, 2006, with the Black-Scholes method of valuation being used to calculate the fair value of options granted. The Company adopted SFAS 123R using the modified-prospective transition method. Under that transition method compensation cost includes; (a) compensation cost for all share-based payments granted prior to, but not yet 76 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) vested as of, January 1, 2006, based on grant date fair value estimated in accordance with the original provisions of SFAS 123 and (b) compensation cost for all share based payments granted subsequent to January 1, 2006, based on grant date fair values estimated in accordance with the provisions of SFAS 123R. Results for periods prior to the adoption of SFAS 123R were not restated. On July 21, 2008, the Company adopted the Employee Share Option Plan 2008 (the “2008 Employee Plan”) pursuant to which the Compensation Committee of the Company’s Board of Directors may grant options to any employee, or any director holding a salaried office or employment with the Company or a Subsidiary for the purchase of ordinary shares. On the same date, the Company also adopted the Consultants Share Option Plan 2008 (the “2008 Consultants Plan”), pursuant to which the Compensation Committee of the Company’s Board of Directors may grant options to any consultant, adviser or non-executive director retained by the Company or any Subsidiary for the purchase of ordinary shares. Each option granted under the 2008 Employees Plan or the 2008 Consultants Plan (together the “2008 Option plans”) will be an employee stock option, or NSO, as described in Section 422 or 423 of the Code. Each grant of an option under the 2008 Options Plans will be evidenced by a Stock Option Agreement between the optionee and the Company. The exercise price will be specified in each Stock Option Agreement, however option prices will not be less than 100% of the fair market value of an ordinary share on the date the option is granted. An aggregate of 6.0 million ordinary shares have been reserved under the 2008 Employee Plan as reduced by any shares issued or to be issued pursuant to options granted under the 2008 Consultants Plan under which a limit of 400,000 shares applies. Further, the maximum number of ordinary shares with respect to which options may be granted under the 2008 Employee Option Plan during any calendar year to any employee shall be 400,000 ordinary shares. There is no individual limit under the 2008 Consultants Option Plan. No options may be granted under the plans after July 21, 2018. On July 21, 2008, the Company adopted the the 2008 Employees Restricted Share Unit Plan (the “2008 RSU Plan”) pursuant to which the Compensation Committee of the Company’s Board of Directors may select any employee, or any director holding a salaried office or employment with the Company or a Subsidiary to receive an award under the plan. An aggregate of 1.0 million ordinary shares have been reserved for issuance under the 2008 RSU Plan. Awards under the 2008 RSU may be settled in cash or shares. On January 17, 2003, the Company adopted the Share Option Plan 2003 (the “2003 Plan”) pursuant to which the Compensation Committee of the Board may grant options to officers and other employees of the Company or its subsidiaries for the purchase of ordinary shares. Each grant of an option under the 2003 Plan will be evidenced by a Stock Option Agreement between the employee and the Company. The exercise price will be specified in each Stock Option Agreement. An aggregate of 6.0 million ordinary shares have been reserved under the 2003 Plan; and, in no event will the number of ordinary shares that may be issued pursuant to options awarded under the 2003 Plan exceed 10% of the outstanding shares, as defined in the 2003 Plan, at the time of the grant, unless the Board expressly determines otherwise. Further, the maximum number of ordinary shares with respect to which options may be granted under the 2003 Plan during any calendar year to any employee shall be 400,000 ordinary shares. Share option awards are granted with an exercise price equal to the market price of the Company’s shares at date of grant. Share options typically vest over a period of five years from date of grant and expire eight years from date of grant. The maximum contractual term of options outstanding at December 31, 2008, is eight years. No options can be granted after January 17, 2013. 77 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The following table summarizes the transactions for the Company’s share option plans for the years ended December 31, 2006, December 31, 2007 and December 31, 2008: Options Granted Prior to Jan 15, 1998 * Options Granted Under Plans * Number of Shares * Weighted Average Exercise Price * Weighted Average Grant Date Fair Value * Outstanding at December 31, 2005 . . . . . . . . . 28,280 4,500,304 4,528,584 Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exercised . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cancelled . . . . . . . . . . . . . . . . . . . . . . . . . . . . — (28,280) — 1,637,004 (935,056) (558,548) 1,637,004 (963,336) (558,548) Outstanding at December 31, 2006 . . . . . . . . . — 4,643,704 4,643,704 Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exercised . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cancelled . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,251,430 (634,784) (284,224) 1,251,430 (634,784) (284,224) Outstanding at December 31, 2007 . . . . . . . . . — 4,976,126 4,976,126 Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exercised . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cancelled . . . . . . . . . . . . . . . . . . . . . . . . . . . . Outstanding at December 31, 2008 . . . . . . . . . Vested and exercisable at December 31, 2008 . . 1,282,190 (847,707) (188,346) 1,282,190 (847,707) (188,346) 5,222,263 5,222,263 1,461,513 1,461,513 — — $ 7.88 $ 11.58 $ 6.94 $ 8.32 $ 9.31 $21.26 $ 8.35 $12.27 $12.27 $35.25 $10.05 $20.45 $17.98 $ 11.00 $ 3.65 $ 5.20 $ 3.56 $ 3.88 $ 4.23 $ 8.89 $ 3.82 $ 5.32 $ 5.35 $12.85 $ 4.45 $ 8.13 $ 7.24 $ 4.73 * Comparative figures have been amended to reflect the Bonus Issues, (Stock Splits) which took place with an effective date of October 13, 2006 and August 8, 2008. Non vested shares outstanding as at December 31, 2008, are as follows: Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Average Fair Value Non vested outstanding at December 31, 2007 . . . . 3,617,898 Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Vested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Forfeited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,282,190 (963,598) (175,740) Non vested outstanding at December 31, 2008 . . . . 3,760,750 $13.24 35.25 12.07 20.86 $20.69 $ 5.81 12.85 5.35 8.32 $ 8.21 The weighted average fair value of options granted during the year was U.S.$12.85. The weighted average remaining contractual life of options outstanding and options exercisable at December 31, 2008, was 5.23 years and 3.95 years respectively. 1,059,356 options are expected to vest during the year ended December 31, 2009. There were 963,598 options vested during the year and the weighted average fair value of these options was U.S.$5.35. There were 188,346 options cancelled during the year and the weighted average fair value of these options was U.S.$8.13. The intrinsic value of options exercised during the year was U.S.$8,177,598. The Company calculated the intrinsic value at the market value of options as at December 31, 2008, as per SFAS 123R. The aggregate intrinsic value of options outstanding and options exercisable as at December 31, 2008, was U.S.$8,955,965 and U.S.$12,700,713 respectively. 78 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The total tax benefit recognized in additional paid in capital related to the compensation charge during the year was U.S.$4.1 million (2007: U.S.$1.5 million). The total compensation cost not yet recognized at December 31, 2008, was U.S.$17.5 million and the weighted average period over which this is expected to be recognized is 2.26 years. Outstanding and exercisable share options: The following table summarizes information concerning outstanding and exercisable share options as of December 31, 2008: Options Outstanding Options Exercisable Range Exercise Price Number of Shares Weighted Average Remaining Contractual Life Weighted Average Exercise Price $ 5.32 $ 7.00 $ 7.25 $ 8.60 $ 8.88 $10.42 $11.00 $17.30 $18.00 $18.98 $21.25 $21.76 $22.60 $26.27 $35.33 $36.05 $36.20 $40.81 $41.25 3,840 238,470 101,780 1,030,910 483,873 60,000 907,155 24,000 106,000 9,000 1,033,615 2,450 2,000 8,000 1,182,170 6,000 2,000 20,000 1,000 $5.32 – $41.25 5,222,263 0.08 2.08 1.08 4.17 3.17 5.08 5.17 5.67 5.08 7.92 6.17 6.33 6.67 7.83 7.17 7.42 7.33 7.58 7.67 5.23 $ 5.32 $ 7.00 $ 7.25 $ 8.60 $ 8.88 $10.42 $11.00 $17.30 $18.00 $18.98 $21.25 $21.76 $22.60 $26.27 $35.33 $36.05 $36.20 $40.81 $41.25 $17.98 Number of Shares 3,840 238,470 101,780 245,262 297,121 — 309,183 9,600 34,000 — 221,367 490 400 — — — — — — 1,461,513 Weighted Average Exercise Price $ 5.32 $ 7.00 $ 7.25 $ 8.60 $ 8.88 $10.42 $11.00 $17.30 $18.00 $18.98 $21.25 $21.76 $22.60 $26.27 $35.33 $36.05 $36.20 $40.81 $41.25 $11.00 Options granted at exercise prices from $5.32 to $7.25 have fully vested at December 31, 2008. Substantially all of the options vest over a five year period from the date of grant. Fair value of Stock Options Assumptions Expected volatility is based on the historical volatility of our common stock over a period equal to the expected term of the options; the expected life represents the weighted average period of time that options granted are expected to be outstanding given consideration to vesting schedules, and our historical experience of past vesting and termination patterns. The risk-free rate is based on the U.S. government zero-coupon bonds yield curve in effect at time of the grant for periods corresponding with the expected life of the option. The weighted average fair value of stock options granted during the year ended December 31, 2006, calculated using the Black-Scholes option pricing model, was $5.20 using the following assumptions; expected dividend yield - 0%, risk free interest rate – 4.68%, expected volatility - 45% and expected life – 4.8 years. 79 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The weighted average fair value of stock options granted during the year ended December 31, 2007, calculated using the Black-Scholes option pricing model, was $8.89 using the following assumptions; expected dividend yield - 0%, risk free interest rate – 4.7%, expected volatility - 40% and expected life – 5.11 years. The weighted average fair value of stock options granted during the year ended December 31, 2008, calculated using the Black-Scholes option pricing model, was $12.85 using the following assumptions; expected dividend yield - 0%, risk free interest rate – 3.2%, expected volatility - 35% and expected life – 5.11 years. On August 7, 2008, the Company issued 6,280 restricted share units to certain employees of the Group. These shares are exercisable over periods ranging from February 26, 2009, to February 26, 2011. The market value of the Company’s shares on date of issue was $41.95. Total compensation cost recognized in income: Income from operations for the year ended December 31, 2008, is stated after charging $6.1 million in respect of non-cash stock compensation expense. Non-cash stock compensation expense for the year ended December 31, 2008, has been allocated to direct costs and selling, general and administrative expenses as follows: Year ended December 31, 2006 2007 2008 Direct costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selling, general and administrative . . . . . . . . . . . . . . . . . . . . $ 2,240 $1,826 Total compensation costs . . . . . . . . . . . . . . . . . . . . . . . . . . . $4,066 11. Government Grants Received . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Less accumulated amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Foreign exchange translation adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . Less current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (in thousands) $3,167 $2,581 $5,748 $3,338 $2,720 $6,058 December 31, 2007 December 31, 2008 (in thousands) $ 2,225 (1,384) 463 1,304 (125) $ 2,625 (1,510) 415 1,530 (144) $ 1,179 $ 1,386 Capital grants received may be refundable in full if certain events occur. Such events, as set out in the related grant agreements, include sale of the related asset, liquidation of the Company or failure to comply with other conditions of the grant agreements. No loss contingency has been recognized as the likelihood of such events arising has been assessed as remote. Government grants amortized to the profit and loss account amounted to U.S.$117,000 and U.S.$126,000 for the years ended December 31, 2007 and December 31, 2008 respectively. As of December 31, 2008, the Company had U.S.$1,351,000 in restricted retained earnings, pursuant to the terms of the grant agreements. 12. Share Capital Holders of ordinary shares will be entitled to receive such dividends as may be recommended by the board of directors of the Company and approved by the shareholders and/or such interim dividends as the board of directors of the Company may decide. On liquidation or a winding up of the Company, the par value of the ordinary shares will be repaid out of the assets available for distribution among the holders of the Company’s ADSs and ordinary shares not 80 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) otherwise represented by ADRs. Holders of ordinary shares have no conversion or redemption rights. On a show of hands, every holder of an ordinary share present in person at a general meeting of shareholders, and every proxy, shall have one vote, for each ordinary share held with no individual having more than one vote. During the year ended December 31, 2006, 963,336 options were exercised by employees at an average exercise price of U.S.$6.94 per share for total proceeds of U.S.$6.7 million. During the year ended December 31, 2007, 634,784 options were exercised by employees at an average exercise price of U.S.$8.35 per share for total proceeds of U.S.$5.3 million. During the year ended December 31, 2008, 847,707 options were exercised by employees at an average exercise price of U.S.$10.05 per share for total proceeds of U.S.$8.5 million. On July 21, 2008, the Company’s shareholders approved a bonus issue of ordinary shares (the “Bonus Issue”) to shareholders of record as of the close of business on August 8, 2008 (the “Record Date”). The Bonus Issue provided for each shareholder to receive one bonus ordinary share for each ordinary share held as of the Record Date, effecting the equivalent of a 2-for-1 stock split. The Bonus shares were issued on August 11, 2008, to Ordinary Shareholders and on August 12, 2008, to holders of American Depositary Shares (“ADSs”). The trading price of ICON’s ADSs were adjusted on NASDAQ to effect the Bonus Issue prior to the opening of trading on August 13, 2008. All outstanding ordinary share amounts referenced in the consolidated financial statements and the notes thereto have been retrospectively restated to give effect to the Bonus Issue as if it had occurred as of the date referenced. On September 29, 2006, ICON’s shareholders approved a bonus issue of ordinary shares (the “Bonus Issue”) to shareholders of record as of the close of business on October 13, 2006 (the “Record Date”). The Bonus Issue provided for each shareholder to receive one bonus ordinary share for each ordinary share held as of the Record Date, effecting the equivalent of a 2-for-1 stock split. The Bonus shares were issued on October 16, 2006, to Ordinary Shareholders and on October 23, 2006, to holders of American Depositary Shares (“ADSs”). The trading price of ICON’s ADSs were adjusted on NASDAQ to effect the Bonus Issue prior to the opening of trading on October 24, 2006. All outstanding ordinary share amounts referenced in the consolidated financial statements and the notes thereto have been retrospectively restated to give effect to the Bonus Issue as if it had occurred as of the date referenced. 13. Income Taxes The U.S. based and Irish based subsidiaries file tax returns in the United States and Ireland, respectively. The other foreign subsidiaries are taxed separately under the laws of their respective countries. The components of income before provision for income tax expense are as follows: Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2006 $ 31,212 12,169 8,075 Year ended December 31, 2007 (in thousands) $ 39,063 16,818 16,099 Income before provision for income taxes . . . . . . . . . . . . . . . $ 51,456 $ 71,980 2008 $ 59,720 23,305 15,255 $ 98,280 81 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The components of total income tax expense are as follows: 2006 Year ended December 31, 2007 2008 (in thousands) Provision for income taxes Current: Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total current tax . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Deferred expenses/(benefit): Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total deferred (benefit) /tax . . . . . . . . . . . . . . . . . . . . . . . . . Provision for income taxes . . . . . . . . . . . . . . . . . . . . . . . . . Impact on shareholders equity of the tax consequence of: Stock compensation expense . . . . . . . . . . . . . . . . . . . . . . . . Currency impact of long term funding . . . . . . . . . . . . . . . . . . $ 4,291 8,855 4,389 17,535 (330) (4,445) 164 (4,611) 12,924 (1,109) — $ 4,073 6,909 6,171 17,153 (908) (154) (261) (1,323) 15,830 (1,466) (1,954) $ 6,508 6,674 4,021 17,203 569 2,549 (354) 2,764 19,967 (4,062) (632) Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 11,815 $ 12,410 $ 15,273 Ireland’s statutory income tax rate is 12.5%. The Company’s consolidated effective tax rate differed from the statutory rate as set forth below; 2006 Year ended December 31, 2007 2008 Taxes at Irish statutory rate of 12.5% . . . . . . . . . . . . . . . . . $ 6,430 (2007:12.5%; 2005: 12.5%) Foreign and other income taxed at (reduced)/higher rates . . . . . . Movement in valuation allowance . . . . . . . . . . . . . . . . . . . . Prior year under/(over) provision in respect of foreign taxes . . . Effects of non deductible expenses . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10,575 (6,113) 1,438 538 56 (in thousands) $ 8,998 $ 12,285 6,496 82 (166) 344 76 5,249 1,494 (88) 520 507 $ 12,924 $ 15,830 $ 19,967 82 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The tax effects of temporary differences that give rise to significant portions of deferred tax assets and deferred tax liabilities are presented below: 2006 Year ended December 31, 2007 2008 Deferred tax liabilities: Property, plant and equipment . . . . . . . . . . . . . . . . . . . . . . Goodwill and related assets . . . . . . . . . . . . . . . . . . . . . . . . Other intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . Accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total deferred tax liabilities recognized . . . . . . . . . . . . . . . . . Deferred tax assets: Net operating loss carry forwards . . . . . . . . . . . . . . . . . . . . Property, plant and equipment . . . . . . . . . . . . . . . . . . . . . . Accrued expenses and payments on account . . . . . . . . . . . . . . Stock options exercised . . . . . . . . . . . . . . . . . . . . . . . . . . . Deferred compensation expense . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total deferred tax assets . . . . . . . . . . . . . . . . . . . . . . . . . . . Valuation allowance for deferred tax assets . . . . . . . . . . . . . . Deferred tax assets recognized . . . . . . . . . . . . . . . . . . . . . . . Net deferred tax (liability) /asset . . . . . . . . . . . . . . . . . . . . . $ 1,188 2,742 0 684 41 4,655 5,971 486 4,520 467 370 115 11,929 (3,839) $ 8,090 $ 3,435 (in thousands) $ 1,253 4,274 439 352 46 6,364 6,931 614 6,007 1,556 471 0 15,579 (4,957) $ 10,622 $ 4,258 $ 5,764 5,112 1,219 546 1,008 13,649 9,690 260 6,746 2,426 737 21 19,880 (5,903) $ 13,977 $ 328 $8.3 million of the deferred tax asset of $14.0 million above is non-current. $12.1 million of the deferred tax liability of U.S.$13.7 million is non-current. At December 31, 2008, non-US subsidiaries had operating loss carry forwards for income tax purposes that may be carried forward indefinitely, available to offset against future taxable income, if any, of approximately U.S$ 21.5 million. At December 31, 2008, ICON Central Laboratories Inc., a U.S. subsidiary, had U.S. Federal and State net operating loss carry forwards of approximately U.S. $8.6 million and U.S. $6.9 million, respectively. These net operating losses are available for offset against future taxable income and expire between 2009 and 2028. Of the U.S. $8.6 million U.S. Federal and U.S $6.9 million State net operating losses, approximately U.S $7.2 million and U.S.$5.4 million is currently available for offset against future U.S. Federal and State taxable income, respectively. The subsidiary’s ability to use the remaining U.S. Federal and State net operating loss (“NOL”) carry forwards of U.S. $1.4 million and $1.5 million, respectively, is limited to U.S.$113,000 per year due to the subsidiary experiencing a change of ownership in 2000, as defined by Section 382 of the Internal Revenue Code of 1986, as amended. 83 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The expected expiry dates of these losses are as follows: 2009-2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2012-2016 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2017-2028 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Federal NOL’s $ 452 226 7,877 $ 8,555 (in thousands) $ State NOL’s 339 226 6,360 $ 6,925 In addition, ICON Central Laboratories Inc has alternative minimum tax credit carry forwards of approximately US$0.2 million that are available to reduce future U.S federal regular income taxes, over an indefinite period. At December 31, 2008, ICON Clinical Research Inc. and its U.S. subsidiaries had combined U.S. State net operating loss carry forwards of approximately U.S.$4.9M. These net operating losses are available for offset against future, or in some cases prior, taxable income in the relevant state and generally expire between 2009 and 2028. The expected expiry dates of these losses are as follows: 2009-2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2012-2016 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2017-2028 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Federal NOL’s $ — — — $ — State NOL’s (in thousands) $ — — 4,935 $ 4,935 In addition, ICON Clinical Research Inc has tax credit carry forwards of approximately US$ 0.4 million that are available to reduce future state income taxes, if any. These begin to expire in 2012. The valuation allowance for deferred tax assets as of December 31, 2007, and December 31, 2006 was US$5.0 million and US$3.8 million, respectively. The valuation allowance at December 31, 2008, was approximately US$ 5.9 million. The net change in the total valuation allowance was an increase of US$0.9 million in 2008 and an increase of US$1.2 million during 2007. The valuation allowance at December 31, 2007, and December 31, 2006, was primarily related to tax losses carried forward that, in the judgment of management, are not more likely than not to be realized. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. The Company has not recognized a deferred tax liability for the undistributed earnings of foreign subsidiaries that arose in 2008 and prior years as the Company considers these earnings to be indefinitely reinvested. 84 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The Company adopted the provisions of FIN 48 on January 1, 2007. This did not result in any change to the opening liability for unrecognized tax benefits. A reconciliation of the beginning and ending amount of total unrecognized tax benefits is as follows: Gross amount of unrecognized tax benefits at January 1, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . Increase related to prior year tax positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Decrease related to prior year tax positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Increase related to current year tax positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Settlements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lapse of statute of limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (in thousands) $ 12,878 — (1,343) 2,760 (529) (123) Gross amount of unrecognized tax benefits at December 31, 2008 . . . . . . . . . . . . . . . . . . . . . . $ 13,643 The Company does not anticipate that the amount of unrecognized tax benefits at December 31, 2008, will significantly change in the coming year. Included in the balance of total unrecognized tax benefits at December 31, 2008, are net potential benefits of US$8.8 million, which if recognized, would affect the effective rate on income tax from continuing operations. Interest and penalties recognized as an expense during the year ended December 31, 2008, amounted to US$1.3 million (2007: US$1.3 million) and are included within the provision for income taxes. Total accrued interest and penalties as of December 31, 2008 and January 1, 2008, were US$2.3 million and US$2.1 million respectively and are included in the closing income tax liabilities at those dates. Our major tax jurisdictions are the United States and Ireland. We may potentially be subjected to tax audits in our major jurisdictions. In the United States tax periods open to audit include the years ended May 31, 2005, the seven month transition period ended December 31, 2005, and the years ended December 31, 2006, December 31, 2007 and December 31, 2008. In Ireland tax periods open to audit include the years ended May 31, 2004 and May 31, 2005, the seven month transition period ended December 31, 2005, and the years ended December 31, 2006, December 31, 2007 and December 31 2008. During such audits, local tax authorities may challenge the position taken by us. 14. Significant Concentrations The Company does business with most major international pharmaceutical companies. As at December 31, 2008, the balance for doubtful debts was $7.5 million (2007: $0.32 million). During the year ended December 31, 2008, an additional reserve for doubtful debts of $7.4 million was created and $0.2 million was used. During the year ended December 31, 2007, an additional reserve for doubtful debts of $0.75 million was created and $0.67 million was used. 15. Commitments and Contingencies The Company is not party to any litigation or other legal proceedings that the Company believes could reasonably be expected to have a material adverse effect on the Company’s business, results of operations and financial condition. 85 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) The Company has several non-cancelable operating leases, primarily for facilities, that expire over the next 10 years. These leases generally contain renewal options and require the Company to pay all executory costs such as maintenance and insurance. The Company recognized U.S.$28,450,000, U.S.$35,760,000 and U.S.$45,638,000 in rental expense for the fiscal years ended December 31, 2006, December 31, 2007, and December 31, 2008. Future minimum rental commitments for operating leases with non-cancelable terms in excess of one year are as follows: 2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Thereafter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Minimum rental payments (in thousands) $ 38,227 33,928 26,617 21,995 18,216 29,657 Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 168,640 The Company has a number of capital leases, primarily over furniture and equipment, which expire over the next five years. Future commitments are as follows: 2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Thereafter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Less future finance charges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lease payments (in thousands) $ 292 327 160 — — — (46) Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 733 On November 14, 2008, the Company acquired 100% of the common stock of Prevalere Life Sciences Inc. (“Prevalere”), for an initial cash consideration of $36.8 million, excluding costs of acquisition. Prevalere, located in Whitesboro, New York, is a leading provider of bioanalytical and immunoassay services to pharmaceutical and biotechnology companies. Certain performance milestones were built into the acquisition agreement requiring potential additional consideration of up to $8.2 million if these milestones are achieved during the years ended December 31, 2008 and 2009. Additional consideration of $5.0 million has been accrued at December 31, 2008, in respect of the milestones for the year ended December 31, 2008. No amounts have been accrued for additional consideration potentially payable in respect of the milestones for the year ended December 31, 2009. On July 1, 2004, the Company acquired 70% of the common stock of Beacon Biosciences Inc. (“Beacon”), a leading specialist CRO, which provides a range of medical imaging services to the pharmaceutical, biotechnology and medical device industries, for an initial cash consideration of $9.9 million, excluding costs of acquisition. On December 31, 2008, the remaining 30% of the common stock was acquired by the Company for $17.4 million, excluding costs of acquisition. Certain performance milestones were built into the acquisition agreement for the remaining 30% of Beacon requiring potential additional consideration of up $3.0 million if these milestones are achieved during the year ended December 31, 2009. At December 31, 2008, no amounts have been accrued in respect of the potential additional consideration. 86 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) 16. Business Segment Information The Company operates predominantly in the contract clinical research industry providing a broad range of clinical research and integrated product development services on a global basis for the pharmaceutical and biotechnology industries. The Company also has a central laboratory segment primarily based in New York, USA. This, together with laboratory services based in Dublin, India and Singapore form the central laboratory segment information disclosed below. The Company’s areas of operation outside of Ireland principally include the United Kingdom, United States, Germany, Australia, Argentina, France, Italy, Japan, Israel, Singapore, Canada, Sweden, The Netherlands, Latvia, Russia, Lithuania, Poland, South Africa, India, Hong Kong, Taiwan, Mexico, Brazil, Hungary, Spain, Thailand, South Korea, China, Chile, New Zealand, Denmark, Finland, Peru, Czech Republic, Ukraine, Romania and Colombia. Segment information as at December 31, 2008 and December 31, 2007 and for the years ended December 31, 2006, December 31, 2007 and December 31, 2008, is as follows: a) The distribution of net revenue by geographical area was as follows: Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rest of Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Year ended December 31, (in thousands) 2007 $ 134,268 144,586 316,049 35,819 2008 $ 158,958 254,706 379,140 72,444 2006 $ 66,028 96,868 266,175 26,526 Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 455,597 $ 630,722 $ 865,248 b) The distribution of net revenue by business segment was as follows: Year ended December 31, (in thousands) 2007 2006 2008 Central laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 47,230 408,367 $ 53,512 577,210 $ 71,115 794,133 Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 455,597 $ 630,722 $ 865,248 c) The distribution of income from operations by geographical area was as follows: Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rest of Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Year ended December 31, (in thousands) 2007 $ 40,592 7,234 19,166 2,250 2008 $ 67,264 7,960 20,547 3,733 2006 $ 28,375 2,681 15,216 1,544 Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 47,816 $ 69,242 $ 99,504 87 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) d) The distribution of income from operations by business segment was as follows: Central laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 2,297 45,519 Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 47,816 2006 Year ended December 31, (in thousands) 2007 $ 3,717 65,525 $ 69,242 2008 $ 5,564 93,940 $ 99,504 e) The distribution of property, plant and equipment, net, by geographical area was as follows: December 31, 2007 December 31, 2008 (in thousands) Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rest of Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.S.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 82,127 15,547 29,072 6,680 $133,426 $101,715 18,071 43,976 7,986 $171,748 f) The distribution of property, plant and equipment, net, by business segment was as follows: Central laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . December 31, 2007 December 31, 2008 (in thousands) $ 7,048 126,378 $133,426 $ 12,681 159,067 $171,748 g) The distribution of depreciation and amortization by geographical area was as follows: Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rest of Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Year ended December 31, (in thousands) 2007 $ 5,972 3,738 7,761 1,537 $19,008 2008 $ 8,684 6,162 10,393 2,489 $27,728 2006 $ 5,099 2,489 6,521 840 $14,949 88 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) h) The distribution of depreciation and amortization by business segment was as follows: Central laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i) The distribution of total assets by geographical area was as follows: Year ended December 31, (in thousands) 2007 $ 1,814 17,194 $19,008 2006 $ 1,340 13,609 $14,949 2008 $ 2,247 25,481 $27,728 December 31, 2007 December 31, 2008 (in thousands) Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rest of Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.S.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $202,293 161,746 301,183 27,916 $693,138 $234,159 165,624 442,351 25,151 $867,285 j) The distribution of total assets by business segment was as follows: Central laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . k) The distribution of capital expenditures by geographical area was as follows: December 31, 2007 December 31, 2008 (in thousands) $ 40,562 652,576 $693,138 $ 62,031 805,254 $867,285 Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rest of Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Year ended December 31, (in thousands) 2007 $46,765 8,346 15,727 4,812 $75,650 2006 $13,854 4,073 10,905 2,881 $31,713 2008 $34,429 10,736 21,774 5,185 $72,124 89 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) l) The distribution of capital expenditures by business segment was as follows: Year ended December 31, (in thousands) 2006 2007 2008 Central laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 2,538 29,175 $ 3,874 71,776 $ 8,607 63,517 Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 31,713 $ 75,650 $ 72,124 m) The following table sets forth the clients which represented 10% or more of the Company’s net revenue in each of the periods set out below. Client A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * Net revenue did not exceed 10%. n) The distribution of interest income by geographical area was as follows: Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rest of Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . o) The distribution of interest income by business segment was as follows: Central laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p) The distribution of the tax charge by geographical area was as follows: Year ended December 31, (in thousands) 2007 * 2006 * 2008 * Year ended December 31, (in thousands) 2006 2007 2008 $ 162 2,737 822 44 $ 3,765 $ — $ 221 1,637 988 35 $ 2,881 2,819 1,232 90 $ 4,141 Year ended December 31, (in thousands) 2006 2007 2008 $ 97 3,668 $ 3,765 $ 182 3,959 $ 4,141 $ 108 2,773 $ 2,881 Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rest of Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Year ended December 31, (in thousands) 2007 $ 3,165 4,512 6,755 1,398 $15,830 2006 $ 3,961 2,034 4,411 2,518 $12,924 2008 $ 7,078 1,722 9,224 1,943 $19,967 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) q) The distribution of the tax charge by business segment was as follows: Central laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2006 $ (2,877) 15,801 Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 12,924 17. Supplemental Disclosure of Cash Flow Information Cash paid for interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 54 Cash paid for income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . $11,632 2006 18. New Accounting Pronouncements Year ended December 31, (in thousands) 2007 $ 679 15,151 $15,830 Year ended December 31, (in thousands) 2007 $ 1,491 $13,632 2008 (397) $ 20,363 $19,967 2008 $ 4,963 $19,543 In October 2008, the FASB issued FSP 157-3, Determining the Fair Value of a Financial Asset When the Market for That Asset Is Not Active” (FSP 157-3). FSP 157-3 clarifies the application of SFAS No. 157 in a market that is not active and addresses application issues such as the use of internal assumptions when relevant observable data does not exist, the use of observable information when the market is not active and the use of market quotes when assessing the relevance of observable and unobservable data. FSP 157-3 is effective for all periods presented in accordance with SFAS No. 157. The Company does not expect the adoption of FSP 157-3 to have a material impact on the financial statements. In April 2008, the FASB issued FSP 142-3 Determination of the Useful Life of Intangible Assets (FSP 142-3). FSP 142-3 amends the factors an entity should consider in developing renewal or extension assumptions used in determining the useful life of recognized intangible assets under FASB Statement No. 142 Goodwill and Other Intangible Assets (SFAS No. 142). FSP 142-3 applies prospectively to intangible assets that are acquired individually or with a group of other assets in a business combination or asset acquisition. The Company does not expect the adoption of FSP 142-3 to have a material impact on the financial statements. In December 2007, the FASB issued FASB Statement No. 141R, Business Combinations (SFAS No. 141R) and FASB Statement No. 160, Noncontrolling Interests in Consolidated Financial Statements– an amendment to ARB No. 51 (SFAS No. 160). SFAS No. 141R and SFAS No. 160 require most identifiable assets, liabilities, noncontrolling interests, and goodwill acquired in a business combination to be recorded at “full fair value” and require noncontrolling interests (previously referred to as minority interests) to be reported as a component of equity, which changes the accounting for transactions with noncontrolling interest holders. Both Statements are effective for periods beginning on or after December 15, 2008, and earlier adoption is prohibited. SFAS No. 141R will be applied to business combinations occurring after the effective date. SFAS No. 160 will be applied prospectively to all noncontrolling interests, including any that arose before the effective date. The Company does not expect the adoption of SFAS No. 141R and SFAS No. 160 to have a material impact on the financial statements. In September 2006, the FASB issued FASB Statement No. 157, Fair Value Measurement (SFAS No. 157). Statement 157 defines fair value, establishes a framework for the measurement of fair value, and enhances disclosures about fair value measurements. The Statement does not require any new fair value measures. The Statement is 91 ICON plc NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued) effective for fair value measures already required or permitted by other standards for fiscal years beginning after November 15, 2007. The Company was required to adopt SFAS No. 157 beginning on January 1, 2008. SFAS No. 157 is required to be applied prospectively, except for certain financial instruments. Any transition adjustment will be recognized as an adjustment to opening retained earnings in the year of adoption. In November 2007, the FASB proposed a one-year deferral of SFAS No. 157’s fair-value measurement requirements for nonfinancial assets and liabilities that are not required or permitted to be measured at fair value on a recurring basis. The adoption of SFAS No. 157 has not had a material impact on the financial statements. 19. Related Parties As at December 31, 2008, Amarin Investment Holding Limited (a company controlled by Mr. Thomas Lynch), and Sunninghill Limited (a company controlled by Dr. John Climax) held 1.1 million and 1.5 million shares respectively in Amarin. These respective holdings equate to approximately 3.97% and 5.42% respectively, of Amarin’s issued share capital. Thomas Lynch also serves as Chairman and Chief Executive Officer of Amarin. Amarin is a neuroscience company focused on the research, development and commercialization of drugs for the treatment of central nervous system disorders. During the fiscal year ending May 31, 2005, Amarin contracted ICON Clinical Research Limited (a wholly owned subsidiary of ICON), to conduct a clinical trial on its behalf. The total potential value of this study is $7 million. During the year ended December 31, 2008, the Company recognized $0.2 million of revenue relating to the Amarin contract. At December 31, 2008, $0.3 million was outstanding to be received from Amarin on this trial. As at December 31, 2008, Dr. John Climax and Dr. Ronan Lambe held 3.05% and 2.94% respectively of the issued share capital of NuPathe Inc. (“NuPathe”). NuPathe is a specialty pharmaceutical company specializing in the acquisition and development of therapeutic products in the area of neuroscience. Prior to July 2008 Dr. Climax also served as a non-executive director and chairman of the compensation committee on the Board of NuPathe. During the year ending December 31, 2006, NuPathe engaged ICON Clinical Research Limited, a wholly owned subsidiary of ICON plc, in consulting and clinical trial related activities. During the year ended December 31, 2008, the Company recognized $0.1 million relating to the NuPathe contract. There were no amounts outstanding as at December 31, 2008. Mr Edward Roberts has served as Chairman of Merz GmbH since 2003. Merz is an independent German pharmaceutical company focused on the development of drugs for the treatment of illnesses in the fields of neurology and psychiatry. ICON Clinical Research Limited, a wholly owned subsidiary of ICON plc, has entered into a number of contracts with Merz, for the provision of consulting and clinical trial related activities. The total potential value of these contracts is $44.1 million. During the prior year ended December 31, 2008, ICON recognized a total of $7.6 million of revenue in relation to these activities. There were no amounts outstanding as at December 31, 2008. Prior to June 25, 2007, Dr. Bruce Given served as the President and Chief Executive Officer of Encysive Pharmaceuticals Inc. (“Encysive”). Encysive is a biopharmaceutical company specializing in the development and commercialization of synthetic, small molecule compounds. As of December 31, 2007, Dr. Bruce Given’s holdings in Encysive was less than 0.1% of the issued share capital. During the year ending December 31, 2003, Encysive engaged ICON Clinical Research Limited (a wholly owned subsidiary of ICON), in consulting and clinical trial related activities. During the prior year ending December 31, 2007, ICON recognized a total of $0.1 million of revenue in relation to these activities. No revenue was earned from these activities during the year ended December 31, 2008. As of December 31, 2007, Dr. Ronan Lambe held 1.4 million shares in AGI Therapeutics Limited (“AGI”), a specialty pharmaceutical company focused on developing drug therapies for gastrointestinal diseases and disorders. In January 2006, Dr. Ronan Lambe was appointed a non-executive director of AGI and took up the position of non-executive Chairman from February 2006. During September 2004, AGI engaged ICON Clinical Research Limited (a wholly owned subsidiary of ICON), in consulting and clinical trial related activities. The total value of this study was $2.8 million. No revenue was recognized during the years ended December 31, 2007 and December 31, 2008. There were no amounts outstanding as at December 31, 2007 and December 31, 2008. 92 The Registrant certifies that it meets all of the US requirements for filing on Form 20-F and has duly caused and authorized this annual report to be signed on its behalf. SIGNATURES Date February 19, 2009 ICON plc /s/ Ciaran Murray Ciaran Murray Chief Financial Officer 93 INDEX TO EXHIBITS Exhibit Number Title 3.1 4.1 4.2 4.3 4.4 8.1 10.1(a) 10.1(b) 10.1(c) 10.1(d) 10.2 10.3 10.4 12.1* 12.2* 23.1 * Filed herewith Amended Memorandum and Articles of Association (incorporated by reference to Exhibits 3.1 and 3.2 to the Form 6-k (File No. 333-08704) filed on December 5, 2008). ICON plc Share Option Plan 2003, as updated on October 26, 2006, for the 2006 bonus issue, further updated on February 5, 2007 and updated on July 21, 2008, for the 2008 bonus issue (incorporated by reference to Exhibit 4.1 to the Form S-8 (File No. 333-152802) filed on August 6, 2008). ICON plc Consultants Share Option Plan 2008 (incorporated by reference to Exhibit 4.2 to the Form S-8 (File No. 333-152802) filed on August 6, 2008). ICON plc Employee Share Option Plan 2008 (incorporated by reference to Exhibit 4.3 to the Form S-8 (File No. 333-152802) filed on August 6, 2008). ICON plc Employees Restricted Share Unit Plan (incorporated by reference to Exhibit 4.4 to the Form S-8 (File No. 333-152802) filed on August 6, 2008). List of Subsidiaries (incorporated by reference to Item 4 of Form 20-F filed herewith). Office Space Lease, dated September 25, 1998, between ICON Clinical Research, Inc. and O’Neill Lansdale Properties, L.P. Amended and Restated Office Space Lease, dated January 1, 2001, between ICON Clinical Research and 212 Church Associates, L.P. Amendment Number 1 to the Amended and Restated Office Space Lease, between ICON Clinical Research , Inc. and 212 C Associates, L.P. Amendment Number 2 to the Amended and Restated Office Space Lease, dated January 11, 2005, between ICON Clinical Research , Inc. and 212 C Associates, L.P. Agreement of Lease, dated August 13, 2001, between ICON Clinical Research (UK) Limited, ICON plc and Capital Business Parks Globeside Limited. Agreement of Lease, dated November 29, 2002, between ICON Laboratories, Inc. and MSM Reality Co. LLC, Davrick, LLC and Sholom Blau Co. LLC (together, the “Landlord”). Highwoods Properties Office Lease, dated February 17, 2003, between ICON Clinical Research, Inc. and Highwoods Realty Limited Partnership. Section 302 certifications. Section 906 certifications. Consent of KPMG, Independent Registered Public Accounting Firm 94 Exhibit 12.1 Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, Peter Gray, certify that: 1. I have reviewed this annual report on Form 20-F of ICON plc (“the registrant”). 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting. 5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. Dated: February 19, 2009 /s/ Peter Gray Peter Gray Chief Executive Officer Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 I, Ciaran Murray, certify that: 1. I have reviewed this annual report on Form 20-F of ICON plc (“the registrant”). 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting. 5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. Dated: February 19, 2009 /s/ Ciaran Murray Ciaran Murray Chief Financial Officer Exhibit 12.2 Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 In connection with the Annual Report of ICON plc (the “Company”) on Form 20-F for the year ending December 31, 2008, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Peter Gray, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge: (1) (2) the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and the information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. Date: February 19, 2009 /s/ Peter Gray Peter Gray Chief Executive Officer The foregoing certification is being furnished solely pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code) and is not being filed as part of the report or as a separate disclosure document. A signed original of this written statement required by section 906 has been provided to ICON plc and will be retained by ICON plc and furnished to the Securities and Exchange Commission or its staff upon request. Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 In connection with the Annual Report of ICON plc (the “Company”) on Form 20-F for the year ending December 31, 2008, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Ciaran Murray, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge: (1) (2) the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and the information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. Date: February 19, 2009 /s/ Ciaran Murray Ciaran Murray Chief Financial Officer The foregoing certification is being furnished solely pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code) and is not being filed as part of the report or as a separate disclosure document. A signed original of this written statement required by section 906 has been provided to ICON plc and will be retained by ICON plc and furnished to the Securities and Exchange Commission or its staff upon request. 

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