The two major rating agencies covering our debt rate it as sub-investment grade debt. None of our debt has a rating trigger that would accelerate the repayment date upon a change in rating.
We believe that we have sufficient current cash, liquid resources and realizable assets and investments to meet our liquidity requirements for at least the next twelve months. Longer-term liquidity requirements and debt repayments will need to be met out of future operating cash flows, financial and other asset realizations and future financing. However, events, including a material deterioration in our operating performance as a result of our inability to reintroduce Tysabri to the market, or, even if it were reintroduced to the market, a substantial delay in such reintroduction or, even if Tysabri is timely reintroduced, a material impairment in our ability to sell significant amounts of Tysabri, material adverse legal judgments, fines, penalties or settlements arising from litigation or governmental investigations, failure to receive marketing approval for products under development or the occurrence of other circumstances or events described under "Risk Factors", could materially adversely affect our ability to meet our longer-term liquidity requirements.
We commit substantial resources to our R&D activities, including collaborations with third parties such as Biogen Idec for the development of Tysabri. We expect to commit significant cash resources to the development and commercialization of products in our development pipeline.
We continually evaluate our liquidity requirements, capital needs and availability of resources in view of, among other things, alternative uses of capital, debt service requirements, the cost of debt and equity capital and estimated future operating cash flow. We may raise additional capital, restructure or refinance outstanding debt, repurchase material amounts of outstanding debt (including the Athena Notes, the 6.5% Convertible Notes, the 7.75% Notes and the Floating Rate Notes), consider the sale of interests in subsidiaries, marketable investment securities or other assets or the rationalization of products, or take a combination of such steps or other steps to increase or manage our liquidity and capital resources. Any such actions or steps, including any repurchase of outstanding debt, could be material. In the normal course of business, we may investigate, evaluate, discuss and engage in future company or product acquisitions, capital expenditures, investments and other business opportunities. In the event of any future acquisitions, capital expenditures, investments or other business opportunities, we may consider using available cash or raising additional capital, including the issuance of additional debt.
Item 6. Directors, Senior Management and Employees
A. Directors and Senior Management
Directors
Kyran McLaughlin (60) was appointed a director of Elan Corporation, plc in January 1998 and was appointed chairman of Elan Corporation, plc in January 2005. He is deputy chairman and head of capital markets at Davy Stockbrokers, Ireland's largest stockbroker firm. He is also a director of Ryanair Holdings, plc and is a director of a number of private companies.
Garo H. Armen, PhD (52) was appointed a director of Elan Corporation, plc in February 1994 and served as chairman from July 2002 until January 2005. He has been chairman and chief executive officer of Antigenics, Inc. ("Antigenics") since its initial public offering in February 2000 and held the same positions in its predecessor, Antigenics, LLC since its formation in 1994. Previously, Dr. Armen was with Dean Witter Reynolds as a senior vice president of research and with E.F. Hutton & Company as first vice president, research.
Brendan E. Boushel (74) was appointed a director of Elan Corporation, plc in January 1980. From 1966 until his retirement in 1994, Mr. Boushel was a partner in the Irish law firm of T.T.L. Overend McCarron & Gibbons. Mr. Boushel also holds a number of private company directorships.
Laurence G. Crowley (68) was appointed a director of Elan Corporation, plc in March 1996. He is governor (chairman) of the Bank of Ireland. He is presently chairman of PJ Carroll & Co. and is a director of a number of private companies.
William F. Daniel (53) was appointed a director of Elan Corporation, plc in February 2003. He has served as our secretary since December 2001, having joined us in March 1994 as group financial controller. In July 1996, he was appointed group vice president, finance, group controller and principal accounting officer. From 1990 to 1992, Mr. Daniel was financial director of Xtravision, plc.
Alan R. Gillespie, C.B.E. PhD (54) was appointed a director of Elan Corporation, plc in March 1996. He is chairman of Ulster Bank Limited. From November 1999 until November 2002, he was chief executive officer of CDC Group, plc and was previously a managing director of Goldman Sachs International.
Ann Maynard Gray (59) was appointed a director of Elan Corporation, plc in February 2001. She was formerly president of Diversified Publishing Group of Capital Cities/ABC, Inc. Ms. Gray is also a director of Duke Energy Corporation and The Phoenix Companies, Inc.
John Groom (66) was appointed a director of Elan Corporation, plc in July 1996 and served as president and chief operating officer from then until his retirement in January 2001. Mr. Groom was president, chief executive officer and director of Athena Neurosciences Inc., ("Athena Neurosciences") prior to its acquisition by us in 1996. Mr. Groom serves on the boards of Neuronyx Inc., Ligand, CV Therapeutics and Amarin Corporation plc ("Amarin").
G. Kelly Martin (46) was appointed a director of Elan Corporation, plc in February 2003 following his appointment as president and chief executive officer. He was formerly president of the International Private Client Group and a member of the executive management and operating committee of Merrill Lynch & Co., Inc. He spent over 20 years at Merrill Lynch & Co., Inc. in a broad array of operating and executive responsibilities on a global basis.
Kieran McGowan (61) was appointed a director of Elan Corporation, plc in December 1998. From 1990 until his retirement in December 1998, he was chief executive of IDA Ireland. He is chairman of the Governing Authority of University College Dublin and is a director of CRH, plc, Irish Life and Permanent, plc, United Drug, plc, Enterprise Ireland, An Post National Lottery Company Ltd., and a number of private companies.
Kevin M. McIntyre, MD (69) was appointed a director of Elan Corporation, plc in February 1984. He is an associate clinical professor of medicine at Harvard Medical School and has served as a consultant to the National Academy of Sciences.
Dennis J. Selkoe, MD (61) was appointed a director of Elan Corporation, plc in July 1996, following our acquisition of Athena Neurosciences, where he served as a director since July 1995. Dr. Selkoe was a founder of, and consultant to, Athena Neurosciences. Dr. Selkoe, a neurologist, is a professor of neurology and neuroscience at Harvard Medical School. He also serves as co-director of the Center for Neurologic Disease at The Brigham and Women's Hospital.
The Honorable Richard L. Thornburgh (72) was appointed a director of Elan Corporation, plc in March 1996. He served as governor of Pennsylvania for two terms and as attorney general of the United States from 1988 to 1991. He is presently of counsel to the law firm of Kirkpatrick & Lockhart LLP in Washington, D.C. He was appointed lead independent director of Elan in May 2002.
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Officers serve at the discretion of the board of directors. Directors of Elan Corporation, plc are compensated with fee payments and stock options (with additional payments where directors are members of board committees) and are reimbursed for travel expenses to and from board meetings.
Senior Management
Paul Breen (48) is executive vice president, global services and operations. He joined Elan in July 2001. Prior to joining Elan, he was vice president and joint managing director of Pfizer Pharmaceuticals Ireland. Prior thereto, he was vice president and managing director of Warner-Lambert Company's Irish operations. Mr. Breen holds a degree in science and is a graduate of University College Dublin.
Nigel Clerkin (31) was appointed senior vice president, finance and group controller in January 2004, having previously held a number of financial and strategic planning positions since joining Elan in January 1998. He is also our principal accounting officer. Mr. Clerkin is a chartered accountant and a graduate of Queen's University Belfast.
Richard Collier (51) joined Elan as executive vice president and general counsel in November 2004. Prior to joining Elan, Mr. Collier was senior counsel at Morgan, Lewis & Bockius LLP. Prior to joining Morgan Lewis, he was senior vice president and general counsel at Pharmacia Corporation ("Pharmacia"), after serving in that same position at Pharmacia & Upjohn. Prior to his experience at Pharmacia, Mr. Collier spent 11 years at Rhone-Poulenc Rorer, Inc. Previously, he was in private practice after having served with the U.S. Federal Trade Commission and U.S. Department of Justice.
Shane Cooke (42) joined Elan as executive vice president and chief financial officer in July 2001. Prior to joining Elan, Mr. Cooke was chief executive of Pembroke Capital Limited, an aviation leasing company, and prior to that held a number of senior positions in finance in the banking and aviation industries. Mr. Cooke is a chartered accountant and a graduate of University College Dublin.
Lars Ekman MD, PhD (55) was appointed executive vice president and president, global R&D since joining Elan in 2001. Prior to joining Elan, he was EVP, R&D, at Schwarz Pharma AG since 1997. From 1984 to 1997, Dr. Ekman was employed in a variety of senior scientific and clinical functions at Pharmacia (now Pfizer). Dr. Ekman is a board certified surgeon with a PhD in experimental biology and has held several clinical and academic positions in both the United States and Europe. He obtained his PhD and MD from the University of Gothenburg, Sweden.
Allison Hulme, PhD (41) was appointed executive vice president, therapeutic franchise group for Elan in January 2005. Previously, Dr. Hulme held the positions of executive vice president, Tysabri business enterprise and senior vice president, head of global development. Prior to joining Elan in October 1995, Dr. Hulme held several positions in Clinical Research at Glaxo Wellcome Pharmaceuticals (United Kingdom) and served as Lecturer at Luton University.
Karen S. Kim (42) was appointed executive vice president, strategy, business development, brand management & communications, in January 2005. She joined Elan in September 2003 as senior vice president, head of global corporate strategy and strategic alliances. Prior to joining Elan, Ms. Kim held senior management positions at Merrill Lynch, which she joined in 1998, and where she most recently was head of Client Development in the International Private Client Group. Previously, she held senior management positions with the Cambridge Group and The MAC Group/Gemini Consulting.
Ivan Lieberburg, MD, PhD (55) is executive vice president and chief medical officer of Elan, where he has held a number of senior positions, most recently senior vice president of research. Prior to joining Athena Neurosciences in 1987, Dr. Lieberburg held faculty positions at the Albert Einstein College of Medicine and Mt. Sinai School of Medicine in New York.
Kathleen Martorano (43) was appointed executive vice president, strategic human resources, and a member of the office of the chief executive officer, in January 2005. She joined Elan in May 2003 as senior vice president, corporate marketing & communications. Prior to joining Elan, Ms. Martorano held senior management positions at Merrill Lynch, which she joined in 1996, and where she most recently was first vice president of Marketing and Communications for the International Private Client Group. Previously, she held senior management positions with Salomon Brothers.
No director or officer has a family relationship with any other director or officer.
B. Compensation
Executive Officers and Directors' Remuneration
For the year ended December 31, 2004, all executive officers and directors as a group (19 persons) received total compensation of $6.4 million.
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We reimburse officers and directors for their actual business-related expenses. For the year ended December 31, 2004, an aggregate of $0.4 million was accrued to provide pension, retirement and other similar benefits for directors and officers. We also maintain certain health and medical benefit plans for our employees in which our officers participate.
Directors' Remuneration
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Year Ended December 31 |
Executive Directors: | | 2004 Salary/Fees | | 2004 Annual Bonus | | 2004 Pension | | 2004 Benefit In Kind | | 2004 Total | | 2003 Total |
G. Kelly Martin | | $ | 834,831 | | | $ | — | (1) | | $ | 6,150 | | | $ | 17,271 | | | $ | 858,252 | | | $ | 1,580,540 | |
William Daniel | | | 310,819 | | | | 238,578 | | | | 42,912 | | | | 20,571 | | | | 612,880 | | | | 464,191 | |
Total | | $ | 1,145,650 | | | $ | 238,578 | | | $ | 49,062 | | | $ | 37,842 | | | $ | 1,471,132 | | | $ | 2,044,731 | |
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(1) | Mr. Martin waived his 2004 performance cash bonus and on March 10, 2005 was granted 200,000 stock options with an estimated fair value of $900,000 at an exercise price of $7.47 per share in lieu of his cash bonus. Mr. Martin also received an annual grant of 80,000 stock options on the same date. For additional information on directors' options, please refer to page 64. |
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Year Ended December 31 |
Non-Executive Directors: | | 2004 Fees | | 2004 Annual Bonus | | 2004 Pension | | 2004 Benefit in Kind | | 2004 Total | | 2003 Total |
Kyran McLaughlin | | $ | 96,250 | | | $ | — | | | $ | — | | | $ | — | | | $ | 96,250 | | | $ | 85,000 | |
Garo H. Armen, PhD. | | | 300,000 | | | | — | | | | — | | | | — | | | | 300,000 | | | | 240,000 | |
Brendan E. Boushel | | | 51,250 | | | | — | | | | — | | | | — | | | | 51,250 | | | | 40,000 | |
Laurence G. Crowley | | | 76,250 | | | | — | | | | — | | | | — | | | | 76,250 | | | | 65,000 | |
Alan R. Gillespie, C.B.E. PhD. | | | 63,750 | | | | — | | | | — | | | | — | | | | 63,750 | | | | 53,859 | |
Ann Maynard Gray | | | 88,750 | | | | — | | | | — | | | | — | | | | 88,750 | | | | 77,500 | |
John Groom | | | 51,250 | | | | — | | | | 200,000 | | | | — | | | | 251,250 | | | | 240,000 | |
Kieran McGowan | | | 76,250 | | | | — | | | | — | | | | — | | | | 76,250 | | | | 65,000 | |
Kevin M. McIntyre, MD. | | | 71,250 | | | | — | | | | — | | | | — | | | | 71,250 | | | | 60,000 | |
Dennis J. Selkoe, MD. | | | 51,250 | | | | — | | | | — | | | | — | | | | 51,250 | | | | 65,000 | |
Richard L. Thornburgh | | | 71,250 | | | | — | | | | — | | | | — | | | | 71,250 | | | | 60,000 | |
Daniel P. Tully(1) | | | 88,750 | | | | — | | | | — | | | | — | | | | 88,750 | | | | 77,500 | |
Total | | $ | 1,086,250 | | | $ | — | | | $ | 200,000 | | | $ | — | | | $ | 1,286,250 | | | $ | 1,128,859 | |
Average number of non-executive directors | | | 12 | | | | 12 | |
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(1) | Daniel P. Tully resigned as director on November 1, 2004. |
On February 12, 2002, we entered into a consultancy agreement with Mr. Groom. Mr. Groom received $200,000 in 2002 under this consultancy agreement. Effective July 1, 2003, the consultancy agreement was cancelled and we entered into a pension agreement of $200,000 per annum payable to Mr. Groom until May 16, 2008.
On April 1, 2002, we entered into a consultancy agreement with Dr. Selkoe. Dr. Selkoe is also a party to a consultancy agreement with Athena Neurosciences. Under consultancy agreements, Dr. Selkoe received $76,200 in 2004 and $25,000 in 2003.
| | | | | | | | | | |
Payments to Former Directors: | | 2004 | | 2003 |
Donal Geaney | | $ | 660,304 | | | $ | 1,122,082 | |
Thomas Lynch | | | 459,615 | | | | 899,955 | |
Donald Panoz | | | 160,000 | | | | 160,000 | |
Nancy Panoz | | | 25,000 | | | | 25,000 | |
Total | | $ | 1,304,919 | | | $ | 2,207,037 | |
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On July 9, 2002, Mr. Geaney and Mr. Lynch resigned as chairman and vice-chairman of the board, respectively, as well as from their respective positions as officers of Elan. Under the terms of the agreements, Mr. Geaney and Mr. Lynch continued as employees of Elan as senior advisers to the chairman until July 31, 2004 at their then current base salaries and were entitled to continue to receive the pension and other benefits to which they were then entitled. They were not entitled to any bonuses during that time.
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C. Board Practices
The Board
The roles of chairman and chief executive officer are separated. Under our Corporate Governance Guidelines, two-thirds of the board is independent. The board currently includes 9 independent, non-executive directors who constitute in excess of two-thirds of the board. We adopted a definition of independence based on the rules of the New York Stock Exchange ("NYSE"), the exchange on which the majority of our shares are traded.
The board regularly reviews its responsibilities and those of its committees and management. The board meets regularly throughout the year, and all of the directors have full and timely access to the information necessary to enable them to discharge their duties. The board has reserved certain matters to its exclusive jurisdiction, thereby maintaining control of the Company and its future direction. All directors are appointed by the board, as nominated by its nominating committee, and subsequently elected by the shareholders. Procedures are in place where directors and committees, in furtherance of their duties, may take independent professional advice, if necessary, at our expense. The board has delegated authority over certain areas of our activities to four standing committees, as more fully described below, during 2004. The board held 12 meetings during 2004.
Executive Committee
The executive committee exercised the authority of the board during the interval between board meetings, except to the extent that the board had delegated authority to another committee or to other persons, or had reserved authority to itself or as limited by Irish law. The members of the committee were Dr. Armen, chairman, Mr. McLaughlin, Mr. Crowley, Ms. Gray and Mr. Martin. The executive committee held one formal meeting during 2004. Dr. Armen retired as chairman on January 7, 2005 and Mr. McLaughlin was appointed chairman. On February 3, 2005, the board terminated the executive committee.
Audit Committee
The audit committee, composed entirely of non-executive directors, helps the board in its general oversight of our accounting and financial reporting practices, internal controls and audit functions, and is directly responsible for the appointment, compensation and oversight of our independent auditors. The audit committee periodically reviews the effectiveness of the system of internal control. It monitors the adequacy of internal accounting practices, procedures and controls, and reviews all significant changes in accounting policies. The committee meets regularly with the internal and external auditors and addresses all issues raised and recommendations made by them. The members of the committee in 2004 were Mr. McLaughlin, chairman, Dr. Gillespie and Mr. McGowan. The audit committee held 9 formal meetings during 2004. In January 2005, Mr. McLaughlin retired from the committee and Dr. Gillespie was appointed as chairman. On February 3, 2005, Ms. Gray was appointed to the committee. For additional information on the audit committee, please refer to Item 16A. "Audit Committee Financial Expert" and Item 16C. "Audit Committee."
As part of our code of conduct, we have put in place a confidential email and telephone hot-line to allow employees to report potential violations of laws, rules, regulations or ethical standards. The audit committee reviews these arrangements, and the investigation and follow-up of such reported matters.
Leadership Development and Compensation Committee
The leadership development and compensation committee (the "LDCC"), composed entirely of non-executive directors, reviews our compensation philosophy and policies with respect to executive compensation, fringe benefits and other compensation matters. The committee determines the compensation of the chief executive officer and other executive directors and reviews the compensation of the other members of the executive management. The committee also administers our stock option plans. The members of the committee in 2004 were Mr. McIntyre, chairman, Mr. Crowley, Ms. Gray and Mr. Tully (until November 1, 2004). The LDCC held 12 formal meetings during 2004. On February 3, 2005, Dr. McIntyre stepped down as chairman and Dr. Selkoe was appointed as chairman of the committee and Ms. Gray retired as a member of the committee. Please also refer to the report of the LDCC on pages 62-63.
Nominating Committee
The nominating committee, composed entirely of non-executive directors, reviews on an ongoing basis the membership of the board of directors and of the board committees and the performance of the directors. It recommends new
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appointments to fill any vacancy that is anticipated or arises on the board of directors. During 2004, the Nominating Committee initiated the search for the new chairman of Elan Corporation, plc, which lead to the appointment of Mr. Kyran McLaughlin in January 2005. This involved a process of identifying the skills and experience required for this position. This Committee reviews and recommends changes in respect of the functions of the various committees of the board. Elan's Corporate Governance Guidelines and the charter of the Nominating Committee set out the manner in which the performance evaluation of the board, its committees and the directors is to be performed and by whom. Such evaluations have not been carried out in a formal manner to date. It is currently anticipated that such formal evaluation process will be implemented during 2005. During 2004, members of the committee were Mr. Thornburgh, chairman, Ms. Gray, Mr. McGowan, Mr. McLaughlin and Mr. Tully (until November 1, 2004). The nominating committee held 6 formal meetings during 2004. On March 9, 2005, Mr. Thornburgh stepped down as chairman, and as lead independent director. The directors expect to appoint a new lead independent director in the near future.
The number of board and board committee meetings held and attended by each director during the year was as follows:
| | | | | | | | | | | | | | | | | | | | | | |
| | Board | | Executive Committee | | Audit Committee | | LDCC | | Nominating Committee |
Garo H. Armen, PhD. | | | 12/12 | | | | 1/1 | | | | — | | | | — | | | | — | |
Brendan E. Boushel | | | 11/12 | | | | — | | | | — | | | | — | | | | — | |
Laurence G. Crowley | | | 8/12 | | | | 1/1 | | | | — | | | | 9/12 | | | | — | |
William F. Daniel | | | 12/12 | | | | 1/1 | (1) | | | 9/9 | (1) | | | 12/12 | (1) | | | 6/6 | (1) |
Alan R. Gillespie, C.B.E. PhD. | | | 8/12 | | | | — | | | | 9/9 | | | | — | | | | — | |
Ann Maynard Gray | | | 9/12 | | | | 0/1 | | | | — | | | | 12/12 | | | | 5/6 | |
John Groom | | | 11/12 | | | | — | | | | — | | | | — | | | | — | |
G. Kelly Martin | | | 12/12 | | | | 1/1 | | | | — | | | | — | | | | — | |
Kieran McGowan | | | 8/12 | | | | — | | | | 9/9 | | | | — | | | | 6/6 | |
Kevin M. McIntyre, MD. | | | 12/12 | | | | — | | | | — | | | | 12/12 | | | | — | |
Kyran McLaughlin | | | 10/12 | | | | 1/1 | | | | 9/9 | | | | — | | | | 6/6 | |
Dennis J. Selkoe, MD. | | | 11/12 | | | | — | | | | — | | | | — | | | | — | |
Richard L. Thornburgh | | | 8/12 | | | | — | | | | — | | | | — | | | | 5/6 | |
Daniel P. Tully(2) | | | 5/11 | | | | 0/1 | | | | — | | | | 9/11 | | | | 4/5 | |
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(1) | William Daniel was secretary on these committees. |
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(2) | Daniel Tully resigned as director on 1 November 2004. |
Relations with Shareholders
We communicate regularly with our shareholders throughout the year, specifically following the release of quarterly and annual results, and after major developments. Our general meetings and analyst briefings are webcast and are available on our website (www.elan.com). All shareholders are given adequate notice of the annual meeting. The board periodically receives a presentation by external advisers on investor perceptions and external brokers' reports are circulated to all directors. All directors normally attend the Annual General Meeting and shareholders are invited to ask questions during the meeting and to meet with Directors after the formal proceedings have ended.
Internal Control
The board of directors has overall responsibility for our system of internal control and for monitoring its effectiveness. Management is responsible for the planning and implementation of the system of internal control and ensuring that we apply these controls consistently. Such a system is designed to manage rather than eliminate the risk of failure to achieve business objectives and can only provide reasonable and not absolute assurance against material misstatement or loss.
To provide effective internal control, focus on business objectives and to consider risk, we have:
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• | A formalized risk reporting system. Significant business risks are addressed at each board meeting; |
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• | A clearly defined organizational structure under the day-to-day direction of our chief executive officer. Defined lines of responsibility and delegation of authority have been established within which our activities are planned, executed, controlled and monitored to achieve the strategic objectives that the board has adopted for us; |
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• | A comprehensive system for reporting financial results to the board. This includes a budgeting system with an annual budget approved by the board. The board compares actual results with budgeted results regularly. Management accounts are prepared on a timely basis. They include a profit and loss account, balance sheet, cash flow statement and capital expenditure report, together with an analysis of performance of key operating divisions and subsidiaries; |
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• | A system of management and financial reporting, treasury management and project appraisal. Management is responsible for reporting to the board on its progress in achieving objectives. The system of reporting covers trading activities, operational issues, financial performance, working capital, cash flow and asset management. We report in a timely and regular manner. In this context, progress is monitored against annual budgets and longer term objectives; and |
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• | Corporate compliance and internal controls departments that review key systems and controls. |
Following certain changes in our financial functions, the separate internal audit function ceased in September 2004. At the beginning of 2004, we established a separate internal control department primarily responsible for our Sarbanes-Oxley 404 project. In addition, we continue to have a separate corporate compliance function, which is responsible for all aspects of compliance within Elan. Both these functions report to the board audit committee. We are currently moving to re-instate our internal audit function in a manner that is fully co-ordinated with the other control functions outlined above.
The directors reviewed our system of internal control and also examined the full range of risks affecting us and the appropriateness of the internal control structures to manage and monitor these risks. This process involved a confirmation that appropriate systems of internal control were in place throughout the financial year and up to the date of signing of these Consolidated Financial Statements. It also involved an assessment of the ongoing process for the identification, management and control of the individual risks and of the role of the various risk management functions and the extent to which areas of significant challenges facing us are understood and are being addressed. No material unaddressed issues emerged from this assessment. The directors confirm that they have reviewed, in accordance with the Turnbull Guidance, the effectiveness of our systems of internal control for the year ended December 31, 2004.
Going Concern
The directors, having made inquiries, believe that we have adequate resources to continue in operational existence for at least the next twelve months and that it is appropriate to continue to adopt the going concern basis in preparing our Consolidated Financial Statements.
Report of the Leadership Development and Compensation Committee
The terms of reference for the committee are to determine the compensation, terms and conditions of employment of the chief executive officer and other executive directors and to review the recommendations of the chief executive officer with respect to the remuneration and terms and conditions of employment of our senior management. The committee also exercises all the powers of the board of directors to issue Ordinary Shares on the exercise of stock options and to generally administer our stock option plans.
The chief executive officer attends meetings of the committee except when his own remuneration is being considered.
Each member of the committee is nominated to serve for a three-year term subject to a maximum of two terms of continuous service.
Remuneration Policy
Our policy on executive directors' remuneration is to set remuneration levels that are appropriate for our senior executives having regard to their substantial responsibilities, their individual performance and our performance as a whole. The committee sets remuneration levels after reviewing remuneration packages of executives in the pharmaceutical industry. The committee takes external advice from independent benefit consultants and considers Section B of the Code of Best Practice of The Combined Code as issued by the London and Irish Stock Exchanges.
The typical elements of the remuneration package for executive directors include basic salary and benefits, annual cash incentive bonus, pensions and participation in stock option plans.
The committee grants options to encourage identification with shareholders' interests and to link performance to the long-term share price performance of Elan.
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Executive Directors' Basic Salary
The basic salaries of executive directors are reviewed annually having regard to personal performance, company performance and market practice.
Annual Cash Incentive Bonus
An annual cash incentive bonus, which is not pensionable, is paid on the recommendation of the committee to executive directors. Bonus determination is not based on specific financial or operational targets, but on individual and company performance.
Stock Option Plans
It is the committee's policy, in common with other companies operating in the pharmaceutical industry, to award stock options to management and employees. The options generally vest between one and five years. These plans do not contain any performance conditions.
Employee Equity Purchase Plans
In June 2004, our shareholders and board of directors approved a qualified Employee Equity Purchase Plan (the "U.S. Purchase Plan"), under Sections 421 and 423 of the Internal Revenue Code ("IRS"), which became effective on January 1, 2005 for eligible employees based in the U.S. The plan allows eligible employees to purchase common stock at 85% of the lower of the fair market value at the start of the offering period or the fair market value on the last trading day of the offering period. Purchases are limited to $25,000 per calendar year, 1,000 shares per offering period, and subject to certain IRS restrictions.
Also in June 2004, in connection with the U.S. Purchase Plan, our shareholders and board of directors approved the Irish Sharesave Option Scheme 2004 and U.K. Sharesave Option Plan 2004, effective January 1, 2005, for employees based in Ireland and the United Kingdom, respectively (the "Irish/U.K. Sharesave Plans"). As of December 31, 2004, 1,500,000 shares have been reserved for issuance under the Irish/U.K. Sharesave Plans and U.S. Purchase Plan combined. The Irish/U.K. Sharesave Plans allow eligible employees to purchase at no lower than 85% of the fair market value at the start of the thirty-six month offering period. The plan allows eligible employees to save up to 320 Euros per month under the Irish Scheme or 250 pounds Sterling under the U.K. Plan and they may purchase shares anytime within six months after the end of the savings period.
D. Employees
We employed 1,899 people at December 31, 2004.
E. Share Ownership
Directors' Ordinary Shares
The beneficial interests of those persons who were directors and the secretary of Elan Corporation, plc at December 31, 2004, including their spouses and children under eighteen years of age, were as follows:
| | | | | | | | | | |
| | Ordinary Shares; Par Value 5 Euro Cents Each |
| | 2004 | | 2003 |
Kyran McLaughlin | | | — | | | | — | |
Garo H. Armen, PhD. | | | 270,000 | | | | 270,000 | |
Brendan E. Boushel | | | 838,698 | | | | 838,698 | |
Laurence G. Crowley | | | 12,000 | | | | — | |
William F. Daniel | | | 50,000 | | | | 50,000 | |
Alan R. Gillespie, C.B.E. PhD. | | | 132,000 | | | | 120,000 | |
Ann Maynard Gray | | | 3,500 | | | | 3,500 | |
John Groom | | | 776,720 | | | | 510,000 | |
G. Kelly Martin | | | 257,500 | | | | 257,500 | |
Kieran McGowan | | | 1,200 | | | | 1,200 | |
Kevin M. McIntyre, MD. | | | 179,356 | | | | 179,356 | |
Dennis J. Selkoe, MD. | | | 163,175 | | | | 163,175 | |
Richard L. Thornburgh | | | 12,200 | | | | 200 | |
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Directors' Options
| | | | | | | | | | | | | | | | | | | | | | |
| | At December 31, 2003 | | Granted | | Exercised | | At December 31, 2004 | | Weighted Average Exercise Price |
Kyran McLaughlin | | | 15,000 | | | | 40,000 | | | | — | | | | 55,000 | | | | 21.51 | |
Garo H. Armen, PhD. | | | 1,025,000 | | | | 50,000 | | | | — | | | | 1,075,000 | | | | 4.27 | |
Brendan E. Boushel | | | 25,000 | | | | 40,000 | | | | — | | | | 65,000 | | | | 22.35 | |
Laurence G. Crowley | | | 37,000 | | | | 40,000 | | | | (12,000 | ) | | | 65,000 | | | | 22.35 | |
William F. Daniel | | | 326,000 | | | | 30,705 | | | | — | | | | 356,705 | | | | 17.40 | |
Alan R. Gillespie, C.B.E. PhD. | | | 37,000 | | | | 40,000 | | | | (12,000 | ) | | | 65,000 | | | | 22.35 | |
Ann Maynard Gray | | | 5,000 | | | | 40,000 | | | | — | | | | 45,000 | | | | 20.56 | |
John Groom | | | 316,720 | | | | 40,000 | | | | (266,720 | ) | | | 90,000 | | | | 27.89 | |
G. Kelly Martin | | | 2,000,000 | | | | 60,000 | | | | — | | | | 2,060,000 | | | | 4.91 | |
Kieran McGowan | | | 15,000 | | | | 40,000 | | | | — | | | | 55,000 | | | | 21.51 | |
Kevin M. McIntyre, MD. | | | 25,000 | | | | 40,000 | | | | — | | | | 65,000 | | | | 22.35 | |
Dennis J. Selkoe, MD. | | | 108,648 | | | | 40,000 | | | | (83,648 | ) | | | 65,000 | | | | 22.35 | |
Richard L. Thornburgh | | | 37,000 | | | | 40,000 | | | | (12,000 | ) | | | 65,000 | | | | 22.35 | |
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Options outstanding at December 31, 2004 are exercisable at various dates between January 2005 and March 2014. During the year ended December 31, 2004, the closing market price ranged from $7.06 to $30.09 per ADS. The closing market price at March 31, 2005, on the NYSE of our ADSs was $3.24.
The following changes in directors' interests occurred between December 31, 2004 and March 31, 2005. On February 9, 2005, Mr. McLaughlin purchased 10,000 American Depository Shares ("ADSs"), representing ordinary shares par value €0.05 each ("Ordinary Shares"). On March 10, 2005, options to purchase ordinary shares were granted to the following directors at the then market price of $7.47 per share: Mr. Martin 280,000 options; Dr. Armen, Mr. Boushel, Mr. Crowley, Dr. Gillespie, Ms. Gray, Mr. Groom, Mr. McGowan, Dr. McIntyre, Mr. McLaughlin, Dr. Selkoe and Mr. Thornburgh 7,500 options each and Mr. Daniel 50,000 options.
Item 7. Major Shareholders and Related Party Transactions.
A. Major Shareholders
The following table sets forth certain information regarding the beneficial ownership of Ordinary Shares at March 31, 2005 by major shareholders (based solely upon information obtained from SEC filings) and all of our directors and officers as a group (either directly or by virtue of ownership of our ADSs):
| | | | | | | | | | |
Name of Owner or Identity of Group | | No. of Shares | | Percent of Class (1) |
Capital Research and Management Company ("Capital Research") | | | 32,880,300 | | | | 8.3 | % |
Fidelity Management and Research Company ("Fidelity Management") | | | 19,369,730 | | | | 4.9 | % |
T. Rowe Price Associates, Inc. ("T. Rowe Price") | | | 14,510,829 | | | | 3.7 | % |
All directors and officers as a group (18 persons)(2) | | | 6,801,533 | | | | 1.7 | % |
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(1) | Based on 396.7 million Ordinary Shares outstanding on March 31, 2005 and 4.4 million Ordinary Shares issuable upon the exercise of currently exercisable options held by directors and officers as a group as of March 31, 2005. |
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(2) | Includes 4.4 million Ordinary Shares issuable upon exercise of currently exercisable options held by directors and officers as a group as of March 31, 2005. |
Except for these interests, we are not aware of any person who, directly or indirectly, holds 3% or more of our issued share capital. Neither Capital Research, Fidelity Management nor T. Rowe Price have voting rights different from other shareholders.
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We, to our knowledge, are not directly or indirectly owned or controlled by another entity or by any government. We do not know of any arrangements, the operation of which might result in a change of control of us.
B. Related Party Transactions
There were no significant transactions with related parties during the year ended December 31, 2004 other than as outlined in Note 27 to the Consolidated Financial Statements.
Service Contracts
Except as set out below, there are no service contracts in existence between any of the directors and Elan:
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• | On July 1, 2003, we entered into a pension agreement with Mr. John Groom, a director of Elan Corporation, plc, whereby we shall pay a pension of $200,000 per annum, monthly in arrears, until May 16, 2008 in respect of his former senior executive roles. |
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• | On January 7, 2003, we and EPI entered into an agreement with Mr. G. Kelly Martin such that Mr. Martin was appointed president and chief executive officer effective February 3, 2003. Mr. Martin's annual salary under this agreement is $798,000. He is eligible for an annual bonus in a target amount equal to his salary depending on the achievement of established performance goals. Mr. Martin was granted an initial option to purchase 1,000,000 Ordinary Shares with an exercise price of $3.85 and vesting in three equal installments on December 31, 2003, December 31, 2004 and December 31, 2005. In accordance with the terms of his contract, in October 2003, Mr. Martin was granted an additional option to purchase 1,000,000 Ordinary Shares with an exercise price of $5.28, equal to the fair market value of the shares on the date of grant, vesting on the same basis and dates as the initial option grant. |
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| Mr. Martin has received additional option grants consistent with our annual option grant practices. |
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| The agreement continues until December 31, 2005 and will be extended for a further year on each anniversary of that date thereafter unless Mr. Martin or we give 90 days notice prior to the applicable anniversary date. In general, if Mr. Martin's employment is involuntarily terminated (other than for cause or disability) or Mr. Martin leaves for good reason, we will continue to pay his salary and target bonus for the following two years and his outstanding options will immediately accelerate and remain outstanding for the following two years. |
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| Mr. Martin is eligible to participate in the pension, medical, disability and life insurance plans applicable to senior executives in accordance with the terms of those plans. He may also receive financial planning and tax support and advice from the provider of his choice at a reasonable and customary annual cost. |
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• | On July 1, 1986, Athena Neurosciences entered into a consultancy agreement with Dr. Dennis J. Selkoe, whereby Dr. Selkoe agreed to provide certain consultancy services in the field of Alzheimer's disease for a fee to be fixed annually, together with the reimbursement of all reasonable travel and other expenses incurred. The consultancy agreement renews automatically, unless notice of termination is provided 60 days prior to the anniversary date. No such notice has been provided. |
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• | On April 1, 2002, EPI entered into a consultancy agreement with Dr. Selkoe whereby Dr. Selkoe agreed to provide certain consultancy services, including services in the field of immunological approaches to the treatment of Alzheimer's disease for a period of one year for a fee not to exceed $12,000. |
C. Interest of Experts and Counsel
Not applicable.
Item 8. Financial Information.
A. Consolidated Statements and Other Financial Information
See item 18.
B. Significant Changes
None.
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Item 9. The Offer and Listing.
A. Offer and Listing Details
Not applicable.
B. Plan of Distribution
Not applicable.
C. Markets
The principal trading markets for our Ordinary Shares are the Irish Stock Exchange and the London Stock Exchange. Our ADSs, each representing one Ordinary Share and evidenced by one American Depositary Receipt ("ADR"), are traded on the NYSE under the symbol "ELN". The ADR depositary is The Bank of New York.
The following table sets forth the high and low sales prices of the Ordinary Shares during the periods indicated, based upon mid-market prices at close of business on the Irish Stock Exchange and the high and low sales prices of the ADSs, as reported in published financial sources:
| | | | | | | | | | | | | | | | | | |
| | €0.05 Ordinary Shares | | American Depository Shares (1) |
| | High | | Low | | High | | Low |
Year ended December 31 | | (€) | | ($) |
2000 | | | 66.75 | | | | 26.35 | | | | 60.13 | | | | 26.00 | |
2001 | | | 73.80 | | | | 44.60 | | | | 65.00 | | | | 39.35 | |
2002 | | | 50.27 | | | | 1.23 | | | | 45.18 | | | | 1.03 | |
2003 | | | 7.25 | | | | 2.33 | | | | 9.02 | | | | 2.25 | |
2004 | | | 23.80 | | | | 5.40 | | | | 30.09 | | | | 7.06 | |
Calendar Year | | | | | | | | | | | | | | | | |
2003 | | | | | | | | | | | | | | | | |
Quarter 1 | | | 4.40 | | | | 2.33 | | | | 4.98 | | | | 2.25 | |
Quarter 2 | | | 7.25 | | | | 2.60 | | | | 9.02 | | | | 2.70 | |
Quarter 3 | | | 5.60 | | | | 3.88 | | | | 6.46 | | | | 4.05 | |
Quarter 4 | | | 4.95 | | | | 4.25 | | | | 5.97 | | | | 4.72 | |
2004 | | | | | | | | | | | | | | | | |
Quarter 1 | | | 16.70 | | | | 5.40 | | | | 20.62 | | | | 7.06 | |
Quarter 2 | | | 20.89 | | | | 16.60 | | | | 24.74 | | | | 19.70 | |
Quarter 3 | | | 20.62 | | | | 13.40 | | | | 25.39 | | | | 17.14 | |
Quarter 4 | | | 23.80 | | | | 17.00 | | | | 30.09 | | | | 20.53 | |
Month Ended | | | | | | | | | | | | | | | | |
January 2005 | | | 22.25 | | | | 20.00 | | | | 29.00 | | | | 25.50 | |
February 2005 | | | 22.04 | | | | 6.49 | | | | 28.36 | | | | 8.00 | |
March 2005 | | | 6.33 | | | | 2.40 | | | | 7.97 | | | | 3.24 | |
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(1) | An American Depository Share represents one Ordinary Share, par value 5 Euro cents. |
A total of 396,726,822 Ordinary Shares of Elan were issued and outstanding at March 31, 2005, of which 4,847 Ordinary Shares were held by holders of record in the United States, excluding shares held in the form of ADRs. 342,621,984 Ordinary Shares were represented by our ADSs, evidenced by ADRs, issued by The Bank of New York, as depositary, pursuant to a deposit agreement. At March 31, 2005, the number of holders of record of Ordinary Shares was 7,874, which includes 11 holders of record in the United States, and the number of registered holders of ADRs in the United States was 4,817. Because certain of these Ordinary Shares and ADRs were 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.
In connection with the acquisition of Dura Pharmaceuticals, Inc., we acquired warrants to purchase the Company ADSs, trading on Nasdaq under the symbols "ELANZ" ("Z-Series Warrants"), formerly traded under the symbol "DURAZ",
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and "ELANW" ("W-Series Warrants"), formerly traded under the symbol "DURAW". Each Z-Series Warrant is exercisable for 0.1276 of an ADS at an exercise price of $26.72 per ADS. The Z-Series warrants expire on August 31, 2005. Each W-Series Warrant was exercisable for 0.1679 of an ADS at an exercise price of $81.67 per ADS. The W-Series Warrants expired on December 31, 2002.
In connection with the acquisition of Liposome, we issued Contingent Value Rights (CVRs"). The CVRs began trading on May 15, 2000. CVRs traded on the Nasdaq under the symbol "LCVRZ". The CVRs were delisted from the Nasdaq on September 25, 2002 for failure to comply with the minimum market value of publicly traded units requirement of the Nasdaq Marketplace Rules. The CVRs expired on the termination of the Contingent Value Rights Agreement on March 31, 2003.
The table on the following page sets forth the high and low sales prices for Z-Series Warrants and CVRs for the periods indicated as reported in published financial sources.
| | | | | | | | | | | | | | | | | | |
| | Z-SERIES | | CVRs |
| | HIGH $ | | LOW $ | | HIGH $ | | LOW $ |
2003 – Quarter 1 | | | 0.70 | | | | 0.10 | | | | 0.005 | | | | 0.0001 | |
– Quarter 2 | | | 0.42 | | | | 0.10 | | | | — | | | | — | |
– Quarter 3 | | | 0.23 | | | | 0.10 | | | | — | | | | — | |
– Quarter 4 | | | 0.32 | | | | 0.08 | | | | — | | | | — | |
2004 – Quarter 1 | | | 2.15 | | | | 0.19 | | | | — | | | | — | |
– Quarter 2 | | | 1.15 | | | | 0.58 | | | | — | | | | — | |
– Quarter 3 | | | 0.94 | | | | 0.43 | | | | — | | | | — | |
– Quarter 4 | | | 0.99 | | | | 0.50 | | | | — | | | | — | |
2005 – January | | | 0.75 | | | | 0.60 | | | | — | | | | — | |
– February | | | 0.69 | | | | 0.25 | | | | — | | | | — | |
– March | | | 0.41 | | | | 0.17 | | | | — | | | | — | |
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D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
Item 10. Additional Information.
A. Share Capital
Not applicable.
B. Memorandum and Articles of Association
Objects
Our objects, which are detailed in its Memorandum of Association include, but are not limited to, manufacturing, buying, selling and distributing pharmaceutical products.
Directors
Subject to certain limited exceptions, directors may not vote on matters in which they have a material interest. In the absence of an independent quorum, the directors may not vote compensation to themselves or any member of the board of directors. Directors are entitled to remuneration as shall, from time to time, be voted to them by ordinary resolution of the shareholders and to be paid such expenses as may be incurred by them in the course of the performance of their
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duties as directors. Directors who take on additional committee assignments or otherwise perform additional services for us, outside the scope of their ordinary duties as directors, shall be entitled to receive such additional remuneration as the board may determine. The directors may exercise all of the powers of Elan to borrow money. These powers may be amended by special resolution of the shareholders. There is no requirement for a director to hold shares.
Under the terms of our Articles of Association, one-third of the directors or, if their number is not a multiple of three, then the number nearest to one-third shall retire from office at each Annual General Meeting. The effect of this provision is that each of our directors retires no less than every third year and, occasionally, after two years. Directors are not required to retire at any set age and may offer themselves for re-election at any Annual General Meeting where they are deemed to have retired by rotation.
In accordance with our Articles of Association, Dr. Gillespie, Ms. Gray, Mr. McGowan and Mr. Thornburgh will retire at the 2005 Annual General Meeting. Dr. Gillespie, Ms. Gray and Mr. McGowan being eligible, offer themselves for re-election. Mr. Thornburgh will not be seeking re-election and so will be retiring from the board effective from the conclusion of the 2005 Annual General Meeting. In addition to Mr. Thornburgh, Mr. Boushel and Mr. Groom have notified the Company that they will be retiring from the board effective from the conclusion of the 2005 Annual General Meeting.
Meetings
The Annual General Meeting shall be held in such place and at such time as shall be determined by the board, but no more than 15 months shall pass between the dates of consecutive Annual General Meetings. Directors may call Extraordinary General Meetings at any time. The members, in accordance with our Articles of Association and Irish company law, may also requisition extraordinary General Meetings. Notice of an Annual General Meeting (or any special resolution) must be given at least 21 clear days prior to the scheduled date and, in the case of any other general meeting, with not less than 14 clear days notice.
Rights, Preferences and Dividends Attaching to Shares
All unclaimed dividends may be invested or otherwise made use of by the directors for the benefit of us until claimed. All of the shareholders entitled to attend and vote at the Annual General Meeting are likewise entitled to vote on the re-election of directors. We are permitted under our Memorandum and Articles of Association to issue redeemable shares on such terms and in such manner as the shareholders may determine by special resolution. The liability of the shareholders to further capital calls is limited to the amounts remaining unpaid on shares.
Actions Necessary to Change the Rights of Shareholders
The rights attaching to the different classes of shares may be varied by special resolution passed at a class meeting of that class of shareholders. The additional issuance of further shares ranking pari passu with, or subordinate to, an existing class shall not, unless specified by the Articles or the conditions of issue of that class of shares, be deemed to be a variation of the special rights attaching to that class of shares.
Limitations on the Right to Own Shares
There are no limitations on the right to own shares in the Memorandum and Articles of Association. However, there are some restrictions on financial transfers between Ireland and other specified countries, more particularly described in the section on "Exchange Controls and Other Limitations Affecting Security Holders".
Other Provisions of the Memorandum and Articles of Association
There are no provisions in the Memorandum and Articles of Association:
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• | Delaying or prohibiting a change in control of Elan that operate only with respect to a merger, acquisition or corporate restructuring; |
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• | Discriminating against any existing or prospective holder of shares as a result of such shareholder owning a substantial number of shares; or |
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• | Governing changes in capital, where such provisions are more stringent than those required by law. |
We incorporate by reference all other information concerning our Memorandum and Articles of Association from the section entitled "Description of Ordinary Shares" in the Registration Statement on Form 8-A/A3 (SEC File No. 001-13896) we filed with the SEC on December 6, 2004.
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C. Material Contracts
Indenture
Under an Indenture dated November 16, 2004 with The Bank of New York, as Trustee, two of our subsidiaries co-issued senior notes consisting of $850.0 million aggregate principal amount of 7.75% Notes due 2011 and $300.0 million aggregate principal amount of Floating Rate Notes due 2011. The Floating Rate Notes bear interest at a rate, adjusted quarterly, equal to three-month LIBOR plus 4.0%, except the first interest payment, which bears interest at a rate equal to six-month LIBOR plus 4.0%. Most of our subsidiaries and we guarantee the 7.75% Notes, the Floating Rate Notes, and the Athena Notes.
See Note 15 to the Consolidated Financial Statements for additional information concerning our outstanding debt.
Development and Marketing Collaboration Agreement with Biogen Idec
In August 2000, we entered into a development and marketing collaboration agreement with Biogen Idec, successor to Biogen, Inc., to collaborate in the development, manufaturing and commercialization of Tysabri. Along with Biogen Idec, we are developing Tysabri for MS, Crohn's disease and RA, with Biogen Idec acting as the lead party for MS and Elan acting as the lead party for Crohn's disease and RA.
In November 2004, Tysabri received regulatory approval in the U.S. for the treatment of relapsing forms of MS. Biogen Idec paid us a $7.0 million approval-based milestone. The approval milestone payment, together with other milestone payments related to the collaboration agreement of $45.0 million, are recognized as revenue based on the percentage-of-completion method, which is based on the percentage of costs incurred to date compared to the total costs expected under the contract.
Biogen Idec manufactures Tysabri. We purchase Tysabri from Biogen Idec for distribution to third parties in the U.S. We recorded $6.4 million in product revenue from Tysabri in 2004. In general, we share with Biogen Idec most development and commercialization costs. At December 31, 2004, we owed Biogen Idec $34.4 million for the reimbursement of costs related to development and commercialization.
On February 28, 2005, we and Biogen Idec announced the voluntary suspension of the marketing and dosing in clinical trials of Tysabri. This decision was based on reports of two serious adverse events in patients treated with Tysabri in combination with Avonex in clinical trials. These events involved two cases of PML, a rare and frequently fatal demyelinating disease of the central nervous system. Both patients received more than two years of Tysabri therapy in combination with Avonex. On March 30, 2005, we and Biogen Idec announced that our ongoing safety evaluation of Tysabri led to a previously diagnosed case of malignant astrocytoma being reassessed as PML, in a patient in an open label Crohn's disease clinical trial. The patient had received eight doses of Tysabri over an 18 month period. The patient died in December 2003.
We are working with leading experts, regulatory authorities and the clinical investigators to investigate these serious adverse events and to determine the appropriate path forward.
Wyeth Collaboration Agreement
Under our collaboration agreement with Wyeth, we are developing amyloid immunotherapies to attempt to treat Alzheimer's disease. See Item 4. B "Business Overview" for additional information regarding our Wyeth collaboration.
D. Exchange Controls
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 depositary receipts of Irish companies such as us. 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 that would be movements of capital or payments within the meaning of the treaties governing the member states of the EU. The acquisition or disposal of ADSs or ADRs representing shares issued by an Irish incorporated company and associated payments falls within this definition.
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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 Iraq, the Federal Republic of Yugoslavia, the Republic of Serbia, Zimbabwe, the Taliban of Afghanistan, Osama bin Laden and Al-Qaeda, Burma/Myanmar, Slobodan Milosevic, Associated Persons, Liberia 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 that 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: Federal Republic of Yugoslavia, Republic of Serbia, Iraq, Liberia, Burma/Myanmar, Zimbabwe, the Taliban of Afghanistan, Osama bin Laden and Al-Qaeda and Slobodan Milosevic. We do not anticipate that orders under the Financial Transfers Act, 1992, or United Nations sanctions implemented into Irish law will have a material effect on our business.
E. Taxation
The following is a general description of Irish taxation inclusive of certain Irish tax consequences to U.S. Holders (as defined below) of the purchase, ownership and disposition of ADSs or Ordinary Shares. As used herein, references to the Ordinary Shares include ADSs representing such Ordinary Shares, unless the tax treatment of the ADSs and Ordinary Shares has been specifically differentiated. This description is for general information purposes only and does not purport to be a comprehensive description of all the Irish tax considerations that may be relevant in a U.S. Holder's decision to purchase, hold or dispose of Ordinary Shares of us. It is based on the various Irish Taxation Acts, all as in effect on March 31, 2005 and all of which are subject to change (possibly on a retroactive basis). The Irish tax treatment of a U.S. Holder of Ordinary Shares may vary depending upon such holder's particular situation, and holders or prospective purchasers of Ordinary Shares are advised to consult their own tax advisors as to the Irish or other tax consequences of the purchase, ownership and disposition of Ordinary Shares.
For the purposes of this tax description, a "U.S. Holder" is a holder of Ordinary Shares that is: (i) a citizen or resident of the United States; (ii) a corporation or partnership created or organized in or under the laws of the United States or of any political subdivision thereof; (iii) an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or (iv) a trust, if a U.S. court is able to exercise primary supervision over the administration of such trust and one or more U.S. persons have the authority to control all substantial decisions of such trust.
Taxation of Corporate Income
We are a public limited company incorporated, and resident for tax purposes, in Ireland. Under current Irish legislation, a company is regarded as resident for tax purposes in Ireland if it is centrally managed and controlled in Ireland, or, in certain circumstances, if it is incorporated in Ireland. The Taxes Consolidation Act, 1997, provides that a company that is resident in Ireland and is not resident elsewhere shall be entitled to have any income from a qualifying patent disregarded for taxation purposes. The legislation does not provide a termination date for this relief. A qualifying patent means a patent in relation to which the research, planning, processing, experimenting, testing, devising, designing, developing or similar activities leading to the invention that is the subject of the patent were carried out in Ireland. Income from a qualifying patent means any royalty or other sum paid in respect of the use of the invention to which the qualifying patent relates, including any sum paid for the grant of a license to exercise rights under such patent, where that royalty or other sum is paid, for the purpose of activities that would be regarded under Irish law as the manufacture of goods (to the extent that the payment does not exceed an arms-length rate), or by a person who is not connected with us. Accordingly, our income from such qualifying patents is disregarded for taxation purposes in Ireland. Any Irish manufacturing income of Elan and its subsidiaries is taxable at the rate of 10% in Ireland until December 31, 2010. Income arising from qualifying activities in our Shannon-certified subsidiary is taxable at the rate of 10% in Ireland until December 31, 2005. From January 1, 2006, it is anticipated, based on Irish legislation currently enacted, that such income will be taxable at a rate of 12.5%. Any trading income that does not qualify for the patent exemption or the 10% rate of tax is taxable at the Irish corporation tax rate of 12.5% in respect of trading income for the years 2003 and thereafter. Non-trading income is taxable at 25%.
Taxation of Capital Gains and Dividends
A person who is neither resident nor ordinarily resident in Ireland 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. Unless exempted, all
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dividends paid by us other than dividends paid out of exempt patent income, 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 resident in a country with which Ireland has a double tax treaty, which includes the United States, or in a member state of the EU, other than Ireland (together, a "Relevant Territory"), will be exempt from withholding tax provided he or she makes the requisite declaration.
Corporate shareholders who: (i) are ultimately controlled by residents of a Relevant Territory; (ii) are resident in a Relevant Territory and are not controlled by Irish residents; (iii) have the principal class of their shares, or of a 75% parent, traded on a stock exchange in a Relevant Territory; or (iv) 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.
Holders of our ADSs will be exempt from withholding tax if they are beneficially entitled to the dividend and their address on the register of depositary shares maintained by the depositary is in the United States, provided that the depositary has been authorized by the Irish Revenue Commissioners as a qualifying intermediary and provided the appropriate declaration is made by the holders of the ADSs. Where such withholding is made, it will satisfy the liability to Irish tax of the shareholder except in certain circumstances where an individual shareholder may have an additional liability. A charge to Irish social security taxes and other levies can arise for individuals. However, under the Social Welfare Agreement between Ireland and the United States, an individual who is liable for U.S. social security contributions can normally claim exemption from these taxes and levies.
Irish Capital Acquisitions Tax
A gift or inheritance of Ordinary Shares will be and, in the case of our warrants or ADWSs representing such warrants, may be, within the charge to Irish capital acquisitions tax, notwithstanding that the person from whom the gift or inheritance is received is domiciled or resident outside Ireland. Capital acquisitions tax is charged at the rate of 20% above a tax-free threshold. This tax-free threshold is determined by the relationship between the donor and the successor or donee. It is also affected by the amount of the current benefit and previous benefits taken since 5 December 1991 from persons within the same capital acquisitions tax relationship category. Gifts and inheritances between spouses are not subject to capital acquisitions tax.
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 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, in a case where warrants, ADWSs, ADSs or Ordinary Shares are subject to both Irish capital acquisitions tax with respect to inheritance and U.S. Federal estate tax. The Estate Tax Convention does not apply to Irish capital acquisitions tax paid on gifts.
Irish Stamp Duty
Under current Irish law, no stamp duty, currently at the rate and on the amount referred to below, will be payable by U.S. Holders on the issue of ADSs, Ordinary Shares or ADWSs of Elan. Under current Irish law, no stamp duty will be payable on the acquisition of ADWSs or ADSs by persons purchasing such ADWSs or ADSs, or on any subsequent transfer of an ADWS or ADS of us. A transfer of Ordinary Shares, whether on sale, in contemplation of a sale or by way of gift will attract duty at the rate of 1% on the consideration given or, where the purchase price is inadequate or unascertainable, on the market value of the shares. Similarly, any such transfer of a warrant may attract duty at the rate of 1%. Transfers of Ordinary Shares that are not liable to duty at the rate of 1% are exempt unless the transfer is by way of security, in which event there is a potential maximum charge of Euro 630. 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. Stamp duty is normally payable within 30 days after the date of execution of the transfer. Late or inadequate payment of stamp duty will result in a liability to pay interest penalties and fines.
F. Dividends and Paying Agents
We have not paid cash dividends on our Ordinary Shares in the past and our debt obligations restrict us from paying cash dividends on our capital stock. Although we do not anticipate that we will be able to pay any cash dividends on our Ordinary Shares in the foreseeable future, we expect that the board of directors will review our dividend policy on a
71
regular basis. Dividends may be paid on our Executive Shares and B" Executive Shares at a time when no dividends are being paid on the Ordinary Shares. For additional information regarding the Executive Shares and B" Executive Shares, please refer to Note 22 to the Consolidated Financial Statements.
G. Statement by Experts
Not applicable.
H. Documents on Display
We are subject to the reporting requirements of the Exchange Act. In accordance with these requirements, we file Annual Reports on Form 20-F with, and furnish Reports of Foreign Issuer on Form 6-K to, the SEC. These materials, including our Annual Report on Form 20-F for the fiscal year ended December 31, 2004 and the exhibits thereto, may be inspected and copied at the SEC's Public Reference Room at 450 Fifth Street, N.W., Washington D.C. 20549 and at the SEC's regional offices at 500 West Madison Street, Suite 1400, Chicago, Illinois 60661-2511, and 233 Broadway, New York, New York 10274. Copies of the materials may be obtained from the Public Reference Room of the SEC at 450 Fifth Street, N.W., Washington, D.C. at prescribed rates. The public may obtain information on the operation of the SEC's Public Reference Room by calling the SEC in the United States at 1-800-SEC-0330. As a foreign private issuer, all documents which were filed or submitted after November 4, 2002 on the SEC's EDGAR system are available for retrieval on the website maintained by the SEC at http://www.sec.gov. These filings and submissions are also available from commercial document retrieval services.
Copies of our Memorandum and Articles of Association may be obtained at no cost by writing or telephoning us at our principal executive offices. Our Memorandum and Articles of Association are filed with the SEC as Exhibit 3 of our Registration Statement on Form 8-A/A3 (SEC File No. 001-13896) filed with the SEC on December 6, 2004. You may also inspect or obtain a copy of our Memorandum and Articles of Association using the procedures prescribed above.
I. Subsidiary Information
Not applicable.
Item 11. Quantitative and Qualitative Disclosures about Market Risk.
Market risk is the risk of loss from adverse changes in market prices, interest rates and foreign exchange rates. Our future earnings and cash flows are dependent upon prevailing market rates. Accordingly, we manage our market risk by matching projected cash inflows from operating, investing and financing activities with projected cash outflows for debt service, capital expenditures and other cash requirements. The majority of our outstanding debt has fixed interest rates, which minimizes the risk of fluctuating interest rates. Our exposure to market risk includes interest rate fluctuations in connection with our variable rate borrowings and our ability to incur more debt, thereby increasing our debt service obligations, which could adversely affect our cash flows.
Inflation Risk
Inflation had no material impact on our operations during the year.
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Exchange Risk
We are a multinational business operating in many countries. The U.S. dollar is the primary currency in which we conduct business. The U.S. dollar is used for planning and budgetary purposes and as the currency for financial reporting. We have revenues, costs, assets and liabilities denominated in currencies other than U.S. dollars. We manage our non-U.S. dollar foreign exchange risk through derivative financial instruments. We use derivative financial instruments primarily to reduce exposures to market fluctuations in foreign exchange rates. We do not enter into derivative financial instruments for trading or speculative purposes. All derivative contracts entered into are in liquid markets with credit-approved parties. The treasury function operates within strict terms of reference that have been approved by our board of directors.
The U.S. dollar is the base currency against which all identified transactional foreign exchange exposures are managed and hedged. The principal risks to which we are exposed are movements in the exchange rates of the U.S. dollar against the Euro and Japanese Yen. The main exposures are net costs in Euro arising from a manufacturing and research presence in Ireland and the sourcing of raw materials in European markets.
At December 31, 2004, we had entered into a number of forward foreign exchange contracts at various rates of exchange in the normal course of business. The nominal value of forward foreign exchange contracts to sell Japanese Yen for U.S. dollars at that date was $9.4 million and these contracts had a fair value loss of $0.4 million. These contracts all expire on various dates through December 2005. The nominal value of forward foreign exchange contracts to sell U.S. dollars for Euro at December 31, 2004 was $9.0 million and these contracts had a fair value gain of $1.2 million. These contracts all expire on various dates through June 2005.
During 2004, average exchange rates were $1.24 = EUR1. We sell U.S. dollars to buy Euro for costs incurred in Euro. The recent strengthening of the Euro against the U.S. dollar will result in a higher reported cost related to our Euro cost base in 2005 compared to 2004.
Interest Rate Risk on Debt
Our long-term debt is primarily at fixed rates, except for the $300.0 million of Floating Rate Notes issued in November 2004 and interest rate swaps entered into to convert $300.0 million of our fixed rate interest obligations related to the Athena Notes to variable rate interest obligations. Interest rate changes affect the amount of interest on our variable rate debt.
The table below summarizes the market risks associated with our fixed and variable rate long-term and convertible debt outstanding at December 31, 2004 (in millions):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 2005 | | 2006 | | 2007 | | 2008 | | 2009 | | Thereafter | | Total |
Fixed rate debt (1) | | $ | — | | | $ | — | | | $ | — | | | $ | 1,110.0 | | | $ | — | | | $ | 850.0 | | | $ | 1,960.0 | |
Average interest rate | | | | | | | | | | | | | | | 6.94 | % | | | | | | | 7.75 | % | | | 7.29 | % |
Variable rate debt (2)(3) | | $ | — | | | $ | — | | | $ | — | | | $ | — | | | $ | — | | | $ | 300.0 | | | $ | 300.0 | |
Average interest rate | | | | | | | | | | | | | | | | | | | | | | | 6.50 | % | | | 6.50 | % |
Total long-term and convertible debt | | $ | — | | | $ | — | | | $ | — | | | $ | 1,110.0 | | | $ | — | | | $ | 1,150.0 | | | $ | 2,260.0 | |
Average interest rate | | | — | | | | — | | | | — | | | | 6.94 | % | | | — | | | | 7.42 | % | | | 7.19 | % |
|
| |
(1) | Represents 86.7% of all outstanding long-term and convertible debt. |
| |
(2) | Represents 13.3% of all outstanding long-term and convertible debt. |
| |
(3) | Variable interest rates are based on LIBOR. |
| |
| If market rates of interest on our variable rate debt, including the effect of the $300.0 million interest rate swap, increased by 10%, then the increase in interest expense on the variable rate debt would be $0.6 million annually. As of December 31, 2004, the fair value of our total convertible debt and guaranteed notes was $3,700.0 million. The fair values of the debt instruments has decreased significantly with our voluntary suspension of the marketing and clinical dosing ofTysabri in February 2005 to $1,769.0 million at March 31, 2005 primarily due to the decrease in the option value of the 6.5% Convertible Notes. See Note 16 to the Consolidated Financial Statements for additional information on the fair values of debt instruments. |
73
We held three interest rate derivatives associated with our fixed-rate, long-term debt outstanding at December 31, 2004 (in millions):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 2005 | | 2006 | | 2007 | | 2008 | | 2009 | | Thereafter | | Total | | Fair Value |
Interest Rate Swaps | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Fixed to Variable | | $ | — | | | $ | — | | | $ | — | | | $ | 300.0 | | | $ | — | | | $ | — | | | $ | 300.0 | | | $ | 2.7 | |
Average pay rate | | | — | | | | — | | | | — | | | | 5.55 | % | | | — | | | | — | | | | 5.55 | % | | | — | |
Average receive rate | | | — | | | | — | | | | — | | | | 7.25 | % | | | — | | | | — | | | | 7.25 | % | | | — | |
|
Interest Rate Risk on Investments
Our liquid funds are invested primarily in U.S. dollars except for the working capital balances of subsidiaries operating outside of the United States. Interest rate changes affect the returns on our investment funds. Our exposure to interest rate risk on liquid funds is actively monitored and managed with an average duration of less than three months. By calculating an overall exposure to interest rate risk rather than a series of individual instrument cash flow exposures, we can more readily monitor and hedge these risks. Duration analysis recognizes the time value of money and in particular, prevailing interest rates by discounting future cash flows.
The interest rate risk profile of our investments at December 31, 2004 was as follows (in million):
| | | | | | | | | | | | | | | | | | |
| | Fixed | | Floating | | No Interest | | Total |
Cash and cash equivalents | | $ | — | | | $ | 1,372.6 | | | $ | — | | | $ | 1,372.6 | |
Restricted cash | | $ | — | | | $ | 192.7 | | | $ | — | | | $ | 192.7 | |
Marketable Investment Securities (current) | | $ | 12.5 | | | $ | — | | | $ | 53.0 | | | $ | 65.5 | |
Marketable investment securities (non-current) | | $ | 3.1 | | | $ | — | | | $ | 35.9 | | | $ | 39.0 | |
|
Fixed interest rates on investments have a weighted average interest rate of 7.5% (2003: 8.4%), maturing in 2005. The weighted average life of the fixed interest rate investments is 0.1 years (2003: 0.1 years).
Variable interest rates on cash and liquid resources are generally based on the appropriate Euro Interbank Offered Rate, LIBOR or bank rates dependent on principal amounts on deposit.
Credit Risk
Our treasury function transacts business with counterparties that are considered to be low investment risk. Credit limits are established commensurate with the credit rating of the financial institution that business is being transacted with. We do not believe that we have a significant exposure to any one financial counterparty.
We do not currently transact significant business in countries that are subject to major political and economic uncertainty. As a result, we are not materially exposed to any sovereign risk or payment difficulties.
Equity Price Risk
We are exposed to equity price risks primarily on our available for sale securities, which consist of equity investments in quoted companies. At December 31, 2004, current available-for-sale securities had a fair value of $65.5 million and had a cost of $44.6 million. These investments are primarily in emerging pharmaceutical and biotechnology companies. An adverse change in equity prices could result in a material impact in the fair value of our available for sale equity securities.
Item 12. Description of Securities Other than Equity Securities.
Not applicable.
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Part II
Item 13. Defaults, Dividend Arrearages and Delinquencies.
None.
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds.
None.
Item 15. Controls and Procedures
Disclosure Controls and Procedures
We have disclosure controls and procedures (Disclosure Controls") that are designed to ensure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934, as amended (the 1934 Act"), such as our Annual Report on Form 20-F, is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms. Disclosure Controls are also designed to ensure that the information is accumulated and communicated to our management to allow timely decisions regarding required disclosure. Please refer to our officers' certifications included as Exhibits 12.1 and 12.2.
Item 16. Reserved.
Item 16A. Audit Committee Financial Expert
Our board of directors does not have an audit committee financial expert, within the meaning of such phrase under applicable regulations of the SEC, serving on its audit committee. The board of directors believes that all members of its audit committee are financially literate, experienced in business matters, capable of analyzing and evaluating our Consolidated Financial Statements, understanding internal controls and procedures for financial reporting purposes and understanding audit committee functions. The board of directors is seeking an appropriate individual to serve on the board of directors and the audit committee who will meet the requirements necessary to be an audit committee financial expert.
Item 16B. Code of Ethics
Our board of directors adopted a code of conduct that applies to our directors, officers and employees. There have been no material modifications to, or waivers from, the provisions of such code. This code is available on our website at the following address: http://elan.com/governance/code_of_conduct.
Item 16C. Principal Accountant Fees and Services
Our principal accountants are KPMG. The table below summarizes the fees for professional services rendered by KPMG for the audit of our Consolidated Financial Statements and fees billed for other services rendered by KPMG (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Auditors' remuneration: | | | | | | | | |
Audit fees (1) | | $ | 3.6 | | | $ | 5.3 | |
Audit related fees (2) | | | — | | | | 1.2 | |
Total audit and audit-related fees | | | 3.6 | | | | 6.5 | |
Tax fees | | | 0.8 | | | | 0.1 | |
All other fees | | | — | | | | — | |
Total auditors' remuneration | | $ | 4.4 | | | $ | 6.6 | |
|
| |
(1) | Audit services include audit of our Consolidated Financial Statements, as well as work that generally only the independent auditor can reasonably be expected to provide, including comfort letters, statutory audits, and discussions surrounding the proper application of financial accounting or reporting standards. |
| |
(2) | Audit related services are for assurance and related services that are traditionally performed by the independent auditor, including due diligence related to mergers and acquisitions, employee benefit plan audits, and special procedures required to meet certain regulatory requirements. |
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Audit Committee
The audit committee, composed entirely of non-executive directors, helps the board in its general oversight of our accounting and financial reporting practices, internal controls and audit functions, and is directly responsible for the appointment, compensation and oversight of our independent auditors. The audit committee periodically reviews the effectiveness of the system of internal control. It monitors the adequacy of internal accounting practices, procedures and controls, and reviews all significant changes in accounting policies. The committee meets regularly with the internal and external auditors and addresses all issues raised and recommendations made by them. The members of the committee in 2004 were Mr. McLaughlin, chairman, Dr. Gillespie and Mr. McGowan. The audit committee held 9 formal meetings during 2004. In January 2005, Mr. McLaughlin retired from the committee and Dr. Gillespie was appointed as chairman. On February 3, 2005, Ms. Gray was appointed to the committee.
Consistent with SEC policies regarding auditor independence, the audit committee has responsibility for appointing, setting compensation and overseeing the work of the independent auditor. In recognition of this responsibility, the audit committee has established a policy to pre-approve all audit and permissible non-audit services provided by the independent auditor. Prior to engagement of the independent auditor for the next year's audit, management will submit a list of services and related fees expected to be rendered during that year within each of four categories of services to the audit committee for approval: audit services; audit-related services; tax services; and other fees.
Prior to engagement, the audit committee pre-approves all independent auditor services within each category. The fees are budgeted and the audit committee requires the independent auditor and management to report actual fees versus the budget periodically throughout the year by category of service. During the year, circumstances may arise when it may become necessary to engage the independent auditor for additional services not contemplated in the original pre-approval categories. In those instances, the audit committee requires specific pre-approval before engaging the independent auditor.
The audit committee may delegate pre-approval authority to one or more of its members. The member to whom such authority is delegated must report, for informational purposes only, any pre-approval decisions to the audit committee at its next scheduled meeting.
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.
Part III
Item 17. Consolidated Financial Statements.
Not applicable.
Item 18. Consolidated Financial Statements.
Report of Independent Registered Public Accounting Firm
Consolidated Financial Statements of Elan Corporation, plc and subsidiaries
Notes to the Consolidated Financial Statements
76
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Directors and Shareholders of Elan Corporation, plc
We have audited the accompanying consolidated balance sheets of Elan Corporation, plc and subsidiaries as of December 31, 2004 and 2003 and the related consolidated statements of operations, shareholders' equity and other comprehensive income/(loss) and cash flows for each of the years in the three-year period ended December 31, 2004. 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 Consolidated Financial Statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the Consolidated 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 consolidated financial position of Elan Corporation, plc and subsidiaries as of December 31, 2004 and 2003, and the consolidated results of their operations and their cash flows for each of the years in the three-year period ended December 31, 2004 in conformity with accounting principles generally accepted in the United States ("U.S. GAAP"). Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material respects the information set forth therein.
In the fiscal years prior to 2004, the Company prepared its financial statements in conformity with accounting principles generally accepted in Ireland ("Irish GAAP"), and presented in a footnote to such financial statements a reconciliation of shareholders' equity and net income under Irish GAAP to shareholders' equity and net income under U.S. GAAP. As disclosed in Note 2, "Restatements", to the Consolidated Financial Statements, shareholders' equity and net loss under U.S. GAAP for the years ended December 31, 2003 and 2002, as previously disclosed, have been restated to reflect the correction of an error in accounting for an insurance program that did not involve risk transfer and an error in accounting for the income tax effect of net operating loss carryforwards.
KPMG
Dublin, Ireland
April 8, 2005
77
Elan Corporation, plc
Consolidated Statements of Operations
For the Years Ended December 31, 2004, 2003 and 2002
(in millions, except per share data)
| | | | | | | | | | | | | | | | | | |
| | Notes | | 2004 | | 2003 (restated) | | 2002 (restated) |
Product revenue | | | | | | $ | 404.4 | | | $ | 586.7 | | | $ | 742.4 | |
Contract revenue | | | | | | | 77.3 | | | | 98.9 | | | | 350.7 | |
Total revenue | | | 3 | | | | 481.7 | | | | 685.6 | | | | 1,093.1 | |
Operating expenses: | | | | | | | | | | | | | | | | |
Cost of sales | | | | | | | 170.4 | | | | 248.9 | | | | 305.6 | |
Selling, general and administrative expenses | | | | | | | 340.5 | | | | 384.2 | | | | 541.6 | |
Research and development expenses | | | | | | | 257.3 | | | | 277.6 | | | | 353.9 | |
Gain on sale of businesses | | | 21 | | | | (44.2 | ) | | | (267.8 | ) | | | — | |
Restructuring and other charges, net | | | 20 | | | | 59.8 | | | | 403.2 | | | | 500.7 | |
Total operating expenses | | | | | | | 783.8 | | | | 1,046.1 | | | | 1,701.8 | |
Operating loss | | | | | | | (302.1 | ) | | | (360.5 | ) | | | (608.7 | ) |
Net interest and investment (gains)/losses: | | | | | | | | | | | | | | | | |
Net interest expense | | | 15 | | | | 107.8 | | | | 103.8 | | | | 70.7 | |
Net investment (gains)/losses | | | 7 | | | | (114.6 | ) | | | (103.4 | ) | | | 39.2 | |
Impairment of investments | | | 7 | | | | 71.8 | | | | 87.5 | | | | 1,006.0 | |
Loss on sale of investments by EPIL III/Shelly Bay transaction | | | 15 | | | | — | | | | — | | | | 141.6 | |
Charge arising from guarantee to EPIL II noteholders | | | 14 | | | | 47.1 | | | | 49.0 | | | | 295.4 | |
Net interest and investment losses | | | | | | | 112.1 | | | | 136.9 | | | | 1,552.9 | |
Loss from continuing operations before provision for/(benefit from) income taxes | | | | | | | (414.2 | ) | | | (497.4 | ) | | | (2,161.6 | ) |
Provision for/(benefit from) income taxes | | | 18 | | | | (0.5 | ) | | | (22.8 | ) | | | 8.0 | |
Net loss from continuing operations | | | | | | | (413.7 | ) | | | (474.6 | ) | | | (2,169.6 | ) |
Net income/(loss) from discontinued operations (net of tax) | | | 21 | | | | 19.0 | | | | (31.5 | ) | | | (188.6 | ) |
Net loss | | | | | | $ | (394.7 | ) | | $ | (506.1 | ) | | $ | (2,358.2 | ) |
Basic and diluted loss per Ordinary Share: | | | | | | | | | | | | | | | | |
Net loss from continuing operations | | | | | | $ | (1.06 | ) | | $ | (1.33 | ) | | $ | (6.20 | ) |
Net income/(loss) from discontinued operations (net of tax) | | | | | | | 0.05 | | | | (0.09 | ) | | | (0.54 | ) |
Net loss | | | 4 | | | $ | (1.01 | ) | | $ | (1.42 | ) | | $ | (6.74 | ) |
Weighted average number of Ordinary Shares outstanding | | | 4 | | | | 390.1 | | | | 356.0 | | | | 349.7 | |
|
The accompanying notes are an integral part of these Consolidated Financial Statements.
78
Elan Corporation, plc
Consolidated Balance Sheets
As of December 31, 2004 and 2003
(in millions, except shares and par values)
| | | | | | | | | | | | | | |
| | Notes | | 2004 | | 2003 (restated) |
Assets | | | | | | | | | | | | |
Current Assets: | | | | | | | | | | | | |
Cash and cash equivalents | | | | | | $ | 1,347.6 | | | $ | 778.2 | |
Restricted cash | | | 5 | | | | 164.3 | | | | — | |
Accounts receivable, net | | | 6 | | | | 41.5 | | | | 37.9 | |
Marketable investment securities | | | 7 | | | | 65.5 | | | | 349.4 | |
Inventory | | | 8 | | | | 29.0 | | | | 69.5 | |
Held for sale assets | | | 21 | | | | — | | | | 135.2 | |
Prepaid and other current assets | | | 9 | | | | 78.6 | | | | 124.2 | |
Total current assets | | | | | | | 1,726.5 | | | | 1,494.4 | |
Property, plant and equipment | | | 10 | | | | 346.2 | | | | 369.1 | |
Goodwill and other intangible assets | | | 11 | | | | 780.8 | | | | 907.8 | |
Marketable investment securities | | | 7 | | | | 39.0 | | | | 192.9 | |
Restricted cash | | | 5 | | | | 28.4 | | | | 33.1 | |
Other assets | | | 12 | | | | 55.0 | | | | 32.5 | |
Total assets | | | | | | $ | 2,975.9 | | | $ | 3,029.8 | |
Liabilities and Shareholders' Equity | | | | | | | | | | | | |
Current Liabilities: | | | | | | | | | | | | |
Accounts payable | | | | | | $ | 55.0 | | | $ | 26.2 | |
Accrued and other current liabilities | | | 13 | | | | 290.5 | | | | 337.2 | |
EPIL III Notes | | | 15 | | | | 39.0 | | | | — | |
EPIL II guarantee provision | | | 14 | | | | — | | | | 344.5 | |
Deferred revenue | | | 17 | | | | 55.8 | | | | 61.5 | |
Held for sale liabilities | | | 21 | | | | — | | | | 27.9 | |
Total current liabilities | | | | | | | 440.3 | | | | 797.3 | |
Long term and convertible debt | | | 15 | | | | 2,260.0 | | | | 1,500.0 | |
Deferred revenue | | | 17 | | | | 54.6 | | | | 93.3 | |
Other liabilities | | | | | | | 16.0 | | | | 21.3 | |
Total liabilities | | | | | | | 2,770.9 | | | | 2,411.9 | |
Shareholders' Equity: | | | | | | | | | | | | |
Ordinary shares, €0.05 par value, 600,000,000 shares authorized, 395,072,974 and 386,182,274 shares issued and Outstanding at December 31, 2004 and 2003, respectively | | | 22 | | | | 22.6 | | | | 22.0 | |
Executive shares, €1.25 par value, 1,000 shares authorized, 1,000 shares issued and outstanding at December 31, 2004 and 2003 | | | 22 | | | | — | | | | — | |
"B" Executive shares, €0.05 par value, 25,000 shares authorized, 21,375 shares issued and outstanding at December 31, 2004 and 2003 | | | 22 | | | | — | | | | — | |
Additional paid-in capital | | | | | | | 4,796.4 | | | | 4,724.8 | |
Treasury Stock | | | 22 | | | | (17.4 | ) | | | (17.4 | ) |
Accumulated deficit | | | | | | | (4,604.7 | ) | | | (4,210.0 | ) |
Accumulated other comprehensive income | | | 23 | | | | 8.1 | | | | 98.5 | |
Shareholders' equity | | | | | | | 205.0 | | | | 617.9 | |
Total liabilities and shareholders' equity | | | | | | $ | 2,975.9 | | | $ | 3,029.8 | |
|
The accompanying notes are an integral part of these Consolidated Financial Statements.
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Elan Corporation, plc
Consolidated Statements of Shareholders' Equity and Other Comprehensive Income/(Loss)
For the Years Ended December 31, 2004, 2003 and 2002
(in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Number of Shares | | Share Capital | | Additional Paid-in Capital | | Treasury Stock | | Accumulated Deficit (restated) | | Accumulated Other Comprehensive Income/(Loss) | | Total Shareholders' Equity (restated) |
December 31, 2001 | | | 349.8 | | | $ | 19.9 | | | $ | 4,551.9 | | | $ | (17.4 | ) | | $ | (1,345.7 | ) | | $ | 2.3 | | | $ | 3,211.0 | |
Comprehensive loss: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss | | | — | | | | — | | | | — | | | | — | | | | (2,358.2 | ) | | | — | | | | (2,358.2 | ) |
Unrealized gain on securities | | | — | | | | — | | | | — | | | | — | | | | — | | | | 9.4 | | | | 9.4 | |
Reclassification adjustment for gains included in net loss | | | — | | | | — | | | | — | | | | — | | | | — | | | | (30.1 | ) | | | (30.1 | ) |
Currency translation adjustments | | | — | | | | — | | | | — | | | | — | | | | — | | | | 14.9 | | | | 14.9 | |
Minimum pension liability | | | — | | | | — | | | | — | | | | — | | | | — | | | | (9.8 | ) | | | (9.8 | ) |
Total comprehensive loss | | | | | | | | | | | | | | | | | | | | | | | | | | | (2,373.8 | ) |
Stock issued, net of issuance costs | | | 0.6 | | | | — | | | | 5.9 | | | | — | | | | — | | | | — | | | | 5.9 | |
December 31, 2002 | | | 350.4 | | | | 19.9 | | | | 4,557.8 | | | | (17.4 | ) | | | (3,703.9 | ) | | | (13.3 | ) | | | 843.1 | |
Comprehensive loss: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss | | | — | | | | — | | | | — | | | | — | | | | (506.1 | ) | | | — | | | | (506.1 | ) |
Unrealized gain on securities | | | — | | | | — | | | | — | | | | — | | | | — | | | | 90.9 | | | | 90.9 | |
Reclassification adjustment for gains included in net loss | | | — | | | | — | | | | — | | | | — | | | | — | | | | (1.3 | ) | | | (1.3 | ) |
Currency translation adjustments | | | — | | | | — | | | | — | | | | — | | | | — | | | | 12.4 | | | | 12.4 | |
Minimum pension liability | | | — | | | | — | | | | — | | | | — | | | | — | | | | 9.8 | | | | 9.8 | |
Total comprehensive loss | | | | | | | | | | | | | | | | | | | | | | | | | | | (394.3 | ) |
Stock issued, net of issuance costs | | | 35.8 | | | | 2.1 | | | | 167.0 | | | | — | | | | — | | | | — | | | | 169.1 | |
December 31, 2003 | | | 386.2 | | | | 22.0 | | | | 4,724.8 | | | | (17.4 | ) | | | (4,210.0 | ) | | | 98.5 | | | | 617.9 | |
Comprehensive loss: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss | | | — | | | | — | | | | — | | | | — | | | | (394.7 | ) | | | — | | | | (394.7 | ) |
Unrealized loss on securities | | | — | | | | — | | | | — | | | | — | | | | — | | | | (12.1 | ) | | | (12.1 | ) |
Reclassification adjustment for gains included in net loss | | | — | | | | — | | | | — | | | | — | | | | — | | | | (77.5 | ) | | | (77.5 | ) |
Currency translation adjustments | | | — | | | | — | | | | — | | | | — | | | | — | | | | (0.8 | ) | | | (0.8 | ) |
Total comprehensive loss | | | | | | | | | | | | | | | | | | | | | | | | | | | (485.1 | ) |
Tax benefit of stock option deductions | | | — | | | | — | | | | 2.7 | | | | — | | | | — | | | | — | | | | 2.7 | |
Stock issued, net of issuance costs | | | 8.9 | | | | 0.6 | | | | 68.9 | | | | — | | | | — | | | | — | | | | 69.5 | |
Balance at December 31, 2004 | | | 395.1 | | | $ | 22.6 | | | $ | 4,796.4 | | | $ | (17.4 | ) | | $ | (4,604.7 | ) | | $ | 8.1 | | | $ | 205.0 | |
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The accompanying notes are an integral part of these Consolidated Financial Statements.
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Elan Corporation, plc
Consolidated Statements of Cash Flows
For the Years Ended December 31, 2004, 2003 and 2002
(in millions)
| | | | | | | | | | | | | | |
| | 2004 | | 2003 (restated) | | 2002 (restated) |
Cash flows from operating activities: | | | | | | | | | | | | |
Net loss | | $ | (394.7 | ) | | $ | (506.1 | ) | | $ | (2,358.2 | ) |
Adjustments to reconcile net loss to net cash provided by/(used in) operating activities: | | | | | | | | | | | | |
Amortization of deferred revenue | | | (55.6 | ) | | | (87.5 | ) | | | (62.8 | ) |
Amortization of financing costs | | | 5.5 | | | | 13.6 | | | | 9.7 | |
Depreciation and amortization | | | 123.6 | | | | 174.1 | | | | 196.6 | |
(Gain)/loss on sale of investments | | | (114.6 | ) | | | (103.4 | ) | | | 39.2 | |
Impairment of investments | | | 71.8 | | | | 87.5 | | | | 1,006.0 | |
Provision for EPIL II guarantee | | | 47.1 | | | | 49.0 | | | | 295.4 | |
Disposals/write-down of other assets | | | 10.2 | | | | 72.2 | | | | 660.2 | |
Purchase of product royalty rights | | | — | | | | 297.6 | | | | 121.0 | |
Gain on sale of businesses | | | (55.7 | ) | | | (290.7 | ) | | | (177.9 | ) |
Gain on repurchase of LYONs | | | — | | | | (1.6 | ) | | | (37.7 | ) |
Loss on sale of investments by EPIL III/Shelly Bay | | | — | | | | — | | | | 141.6 | |
Waiver fee to EPIL II/III noteholders | | | — | | | | 16.8 | | | | — | |
Receipts from sale of product rights | | | 16.5 | | | | 79.0 | | | | 2.5 | |
Other | | | 23.0 | | | | (25.2 | ) | | | 56.1 | |
Net changes in assets and liabilities: | | | | | | | | | | | | |
Decrease in accounts receivables | | | 5.9 | | | | 13.3 | | | | 242.2 | |
Decrease/(increase) in prepaid and other current assets | | | (21.3 | ) | | | 16.8 | | | | (49.8 | ) |
Decrease/(increase) in inventory | | | 17.1 | | | | 9.9 | | | | (13.0 | ) |
Decrease in accounts payable and accruals and other liabilities | | | (26.7 | ) | | | (243.8 | ) | | | 66.1 | |
Net cash provided by/(used in) operating activities | | | (347.9 | ) | | | (428.5 | ) | | | 137.2 | |
Cash flows from investing activities: | | | | | | | | | | | | |
Proceeds from disposal of property, plant and equipment | | | 44.2 | | | | 27.9 | | | | 8.6 | |
Purchase of property, plant and equipment | | | (57.9 | ) | | | (33.7 | ) | | | (170.2 | ) |
Purchase of investments | | | (1.4 | ) | | | (11.8 | ) | | | (117.1 | ) |
Proceeds from disposal of investments | | | 76.6 | | | | 53.1 | | | | 10.4 | |
Purchase of marketable investment securities | | | — | | | | (2.1 | ) | | | (83.7 | ) |
Sale and maturity of marketable investment securities | | | 178.9 | | | | 185.1 | | | | 222.6 | |
Purchase of intangible assets | | | (41.1 | ) | | | (144.8 | ) | | | (315.5 | ) |
Proceeds from disposal of intangible assets | | | 0.3 | | | | 0.5 | | | | 9.4 | |
Proceeds of business disposals | | | 274.6 | | | | 593.0 | | | | 443.1 | |
Purchase of product royalty rights | | | — | | | | (297.6 | ) | | | (121.0 | ) |
Redemption of investment in Autoimmune | | | — | | | | — | | | | 38.5 | |
Sale of EPIL III assets | | | — | | | | — | | | | 9.3 | |
Net cash provided by/(used in) investing activities | | | 474.2 | | | | 369.6 | | | | (65.6 | ) |
Cash flows from financing activities: | | | | | | | | | | | | |
Proceeds from issue of share capital | | | 70.6 | | | | 167.9 | | | | 5.7 | |
Payment under EPIL II guarantee | | | (391.8 | ) | | | — | | | | — | |
Repayment of EPIL III Notes | | | (351.0 | ) | | | — | | | | (160.0 | ) |
Repayment of loans | | | (11.4 | ) | | | (770.7 | ) | | | (527.6 | ) |
Net proceeds from debt issuance | | | 1,125.1 | | | | 443.9 | | | | — | |
Waiver fee to EPIL II/III noteholders | | | — | | | | (16.8 | ) | | | — | |
Shelly Bay bank loan | | | — | | | | — | | | | 148.0 | |
Repayment of Shelly Bay bank loan | | | — | | | | — | | | | (148.0 | ) |
Net cash provided by/(used in) financing activities | | | 441.5 | | | | (175.7 | ) | | | (681.9 | ) |
Effect of exchange rate changes on cash | | | 1.6 | | | | 12.5 | | | | 11.2 | |
Net increase/(decrease) in cash and cash equivalents | | | 569.4 | | | | (222.1 | ) | | | (599.1 | ) |
Cash and cash equivalents at beginning of year | | | 778.2 | | | | 1,000.3 | | | | 1,599.4 | |
Cash and cash equivalents at end of year | | $ | 1,347.6 | | | $ | 778.2 | | | $ | 1,000.3 | |
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| | | | | | | | | | | | | | |
Supplemental cash flow information: | | | | | | |
Cash paid for interest | | | (110.2 | ) | | | (100.6 | ) | | | (116.5 | ) |
Cash paid for income taxes | | | (0.6 | ) | | | (8.9 | ) | | | (18.6 | ) |
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The accompanying notes are an integral part of these Consolidated Financial Statements.
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Elan Corporation, plc
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. Description of Business
Elan Corporation, plc, an Irish public limited company ("we", "our", "us", "Elan" or the "Company"), is a neuroscience-based biotechnology company headquartered in Dublin, Ireland that is focused on discovering, developing, manufacturing and marketing advanced therapies in neurodegenerative diseases, autoimmune diseases and severe pain.
In February 2004, we announced the formal completion of our recovery plan. The recovery plan had been announced in July 2002 to restructure our businesses, assets and balance sheet in order to enable us to meet our financial commitments. As a cornerstone of the recovery plan, we turned our focus to three core therapeutic areas: neurodegenerative diseases, autoimmune diseases and severe pain. During the course of the recovery plan, we were organized into two business units, Core Elan and Elan Enterprises. With the completion of the recovery plan, we announced the end of operations for our Elan Enterprises business unit. The implementation of the recovery plan resulted in the discontinuation and disposal of many of our products, operations and assets. See Note 21 for additional information.
In February 2004, our operations were reorganized into two business units: Biopharmaceuticals and Global Services and Operations ("GS&O"). Biopharmaceuticals engages in biopharmaceutical research and development ("R&D") activities, and pharmaceutical commercial activities. Biopharmaceutical R&D activities include the discovery and development of products in the therapeutic areas of neurodegenerative diseases, autoimmune diseases and severe pain. Our pharmaceutical commercial activities include the marketing of neurodegenerative and pain management products and hospital products. GS&O focuses on product development and manufacturing to provide technology platforms that address the drug delivery challenges of the pharmaceutical industry. All prior period financial information reflects this change in segmentation. See Note 31 for additional information.
Between 1996 and mid-2001, we pursued collaborations with biotechnology, drug delivery and pharmaceutical companies through a program referred to as "the business venture program". We have not entered into any new business ventures under the business venture program since mid-2001. All business ventures have been terminated, restructured or are now inactive. As a consequence, we do not expect to provide any additional financing to the business ventures and business venture parents. See Note 29 for additional information on business ventures.
We have in the past entered into risk-sharing arrangements. Please refer to Note 30 for information on risk-sharing arrangements. These arrangements have been terminated and we will not earn any revenues from these risk-sharing arrangements or upfront license fees from business ventures in the future.
The composition of our revenue for 2004, 2003 and 2002 is described below in Note 3.
2. Significant Accounting Policies
The following accounting policies have been applied in the preparation of our Consolidated Financial Statements.
(a) Basis of consolidation and presentation of financial information
Prior to the 2004 fiscal year, we prepared our Consolidated Financial Statements, incorporated by reference on our historical Form 20-F, in conformity with Irish generally accepted accounting principles ("Irish GAAP"). Beginning with our 2004 fiscal year, we have adopted accounting principles generally accepted in the United States ("U.S. GAAP") as the basis for the preparation of our Consolidated Financial Statements on this Form 20-F. Accordingly, our Consolidated Financial Statements on this Form 20-F are prepared on the basis of U.S. GAAP for all periods presented.
We also prepare separate Consolidated Financial Statements, included in our Annual Report, in accordance with Irish GAAP, which differs in certain significant respects from U.S. GAAP. The Annual Report under Irish GAAP is a separate document from this Form 20-F.
Unless otherwise indicated, our financial statements and other financial data contained in this Form 20-F are presented in United States dollars ("$"). The accompanying Consolidated Financial Statements include our financial position, results of operations and cash flows and those of our wholly owned subsidiaries. All significant intercompany amounts have been eliminated.
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We have incurred significant losses during the last three fiscal years and anticipate continuing losses for the forseeable future. However, our directors believe that we have adequate resources to continue in operational existence for at least the next twelve months and that it is appropriate to continue to prepare our Consolidated Financial Statements on a going concern basis.
(b) Use of estimates
The preparation of the Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and disclosures in these Consolidated Financial Statements. Actual results could differ from those estimates.
(c) Reclassifications
Certain items in the Consolidated Financial Statements for prior periods have been reclassified to conform to current classifications.
(d) Restatements
Insurance Deposit
In this 2004 Form 20-F, we have adjusted our previously announced unaudited financial information under U.S. GAAP for the fiscal year ended December 31, 2004, and have restated our financial results previously reflected in the U.S. GAAP reconciliation footnote to our previously issued financial statements under Irish GAAP as of and for the years ended December 31, 2003 and 2002, to account for the termination of a historical product liability insurance program, which was established in 2000. As a result of termination of the program in December 2004, we received $21.0 million from the insurance provider, representing a refund of all of our previously paid premiums which had been expensed as paid, plus a return on the amount deposited less administrative costs. Due to the receipt of the refund upon termination of the program, we determined that the program had not resulted in a transfer of risk; therefore, the premiums paid should have been accounted for under the deposit method. Under the deposit method, insurance premiums paid that do not involve risk transfer should be capitalized as a deposit rather than expensed. We currently have no other similar insurance programs in place.
This adjustment increased our previously announced unaudited net loss under U.S. GAAP for 2004 by $18.8 million, from $375.9 million to $394.7 million, and reduced our reported net loss previously reflected in the U.S. GAAP reconciliation footnote to our previously issued financial statements under Irish GAAP for 2003 and 2002 by $2.6 million and $4.1 million, respectively, from $508.7 million to $506.1 million for 2003 and from $2,362.3 million to $2,358.2 million for 2002. In addition, the adjustment increased our previously reported shareholders' equity at December 31, 2003 by $18.8 million, from $599.1 million to $617.9 million, but had no impact on the previously announced unaudited shareholders' equity at December 31, 2004. This restatement had no effect on our previously reported results and shareholders' equity under Irish GAAP as the historical accounting for the insurance program is in conformity with Irish GAAP.
Income Taxes
In our 2003 Annual Report and Form 20-F/A, we restated our reconciliation to U.S. GAAP financial results previously reflected in the U.S. GAAP reconciliation footnote to our previously issued financial statements under Irish GAAP as of and for the year ended December 31, 2003 following a reassessment of net operating loss carryforwards expected to be recognized on a probable basis. This correction reduced our previously reported tax expense by $26.7 million, resulting in a tax benefit of $22.8 million and a net loss of $508.7 million (prior to the restatement described above).
(e) Cash and cash equivalents
Highly liquid debt instruments purchased with an original maturity of three months or less are classified as cash equivalents.
(f) Investments and marketable investment securities and impairment
Our investment portfolio consists primarily of marketable equity securities, convertible preferred stock and interest-bearing debt of other biotechnology companies.
Marketable equity and debt securities are classified into one of three categories in accordance with SFAS No. 115, "Accounting for Certain Investments in Debt and Equity Securities," ("SFAS No. 115"): including trading, available-for-sale, or held-to-maturity.
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| | |
| • | Marketable securities are considered trading when purchased principally for the purpose of selling in the near term. These securities are recorded as short-term investments and are carried at market value. Unrealized holding gains and losses on trading securities are included in other income. We have no trading securities at December 31, 2004. |
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| • | Marketable securities not classified as trading or held-to-maturity are considered available-for-sale. These securities are recorded as either short-term or long-term investments and are carried at fair value, with unrealized gains and losses included in accumulated other comprehensive income/(loss) in stockholders' equity. The assessment for impairment of marketable securities classified as available-for-sale is based on established financial methodologies, including quoted market prices for quoted equity securities. |
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| • | Marketable debt securities are considered held-to-maturity when we have the positive intent and ability to hold the securities to maturity. These securities are carried at cost, less any write-downs for impairments. We have no held-to-maturity securities at December 31, 2004. |
Non-marketable equity and debt securities are carried at cost, less write-down-for-impairments, and are adjusted for impairment based on methodologies, including the Black-Scholes option-pricing model, the valuation achieved in the most recent private placement by an investee, an assessment of the impact of general private equity market conditions, and discounted projected future cash flows. The factors affecting the assessment of impairments include both general financial market conditions for pharmaceutical and biotechnology companies and factors specific to a particular company.
Equity accounting applies where we hold equity in the investee and have the ability to exercise significant influence over the operating and financial policies of the investee. Significant influence is presumed to exist if we own 20% of the investee's common stock and common stock equivalents, but may also exist in situations when we own less than 20% depending on the existence of factors such as representation on the board of directors, participation in policy making processes, material intercompany transactions, interchange of managerial personnel or technological dependency. Certain circumstances, such as majority ownership by another company, can offset the impact of such factors. The determination to use cost or equity accounting requires a significant degree of judgment of the facts and circumstances of a particular investment. Financial asset investments which are accounted for under the equity method are stated at cost, adjusted for our share of the earnings or losses and distributions of the investee after the date of investment, less any provision for impairment in value.
(g) Inventory
Inventory is valued at the lower of cost or market value. In the case of raw materials and supplies, cost is calculated on a first-in, first-out basis and includes the purchase price, including import duties, transport and handling costs and any other directly attributable costs, less trade discounts. In the case of work-in-progress and finished goods, costs include direct labor, material costs and related overhead.
(h) Property, plant and equipment
Property, plant and equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method based on estimated useful lives as follows:
| | | | | | |
Buildings | | 15-40 years |
Leasehold improvements | | Shorter of expected useful life or lease term |
Plant and equipment | | 3-10 years |
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Where events or circumstances indicate that the carrying amount of a tangible asset may not be recoverable, we compare the carrying amount of the asset to its fair value. The carrying amount of the asset is not deemed recoverable if it exceeds the sum of the undiscounted cash flows expected to result from the use and eventual disposition of that asset. In such event, an impairment loss is measured as the excess of the carrying amount over the asset's fair value.
(i) Leasing
Property, plant and equipment acquired under a lease that transfers substantially all of the risks and rewards of ownership to us, are capitalized. Amounts payable under such leases (capital leases), net of finance charges, are shown as current or long-term liabilities as appropriate. Finance charges on capital leases are charged to expense over the term of the lease to give a constant rate of charge in proportion to the capital balances outstanding. Rentals on operating leases are charged to expense on a straight-line basis.
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(j) Goodwill, other intangible assets and impairment
We account for goodwill and identifiable intangible assets in accordance with SFAS No. 142, "Goodwill and Other Intangible Assets," ("SFAS No. 142"). Effective January 1, 2002, goodwill and identifiable intangible assets with indefinite useful lives are no longer amortized, but are instead tested for impairment at least annually. Intangible assets with estimable useful lives are amortized on a straight-line basis over their respective estimated useful lives to their estimated residual values, or based on their projected cash flows for certain intangible assets, and reviewed for impairment in accordance with SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets" ("SFAS No. 144"). Other intangible assets with useful lives ranging from 2 to 20 years are amortized on a straight-line basis.
We review our goodwill for impairment at least annually or whenever events or changes in circumstances indicate that the carrying amount of these assets may not be recoverable. At December 31, 2004, we had no other intangible assets with indefinite lives.
The goodwill impairment test is performed at the reporting unit level. A reporting unit is the same as, or one level below, an operating segment as defined by SFAS No. 131, "Disclosures About Segments of an Enterprise and Related Information." We have two reporting units: Biopharmaceuticals and GS&O. We compare the fair value of each reporting unit with its carrying value, including goodwill. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is not considered impaired. If the carrying amount of a reporting unit exceeds its fair value, the second step of the goodwill impairment test would be performed to measure the amount of impairment charge, if any. The second step compares the implied fair value of the reporting unit goodwill with the carrying amount of that goodwill, and any excess of the carrying amount over the implied fair value is recognized as an impairment charge. The implied fair value of goodwill is determined in the same manner as the amount of goodwill recognized in a business combination is determined, by allocating the fair value of a reporting unit to individual assets and liabilities. The excess of the fair value of a reporting unit over the amounts assigned to its assets and liabilities is the implied fair value of goodwill. The result of our impairment tests did not indicate any impairment in 2004.
At December 31, 2004, we have $19.9 million of other intangible assets and $1.9 million of inventory relating to Tysabri. Tysabri is included in our Biopharmaceuticals segment, which has goodwill with a carrying value of $218.3 million at December 31, 2004. Biopharmaceuticals engages in research, development and commercial activities and includes our autoimmune diseases franchise, our pain franchise (including Prialt), our neurodegenerative diseases franchise (including our Alzheimer's disease programs), and our commercial group for hospital products (including Maxipime and Azactam). As a result of the voluntary suspension of the marketing and clinical dosing of Tysabri in February 2005, we have reassessed our periodic review of goodwill and other intangible assets for impairment. Our reassessment does not indicate impairment at this stage in relation to these assets. For goodwill, the fair value of our Biopharmaceutical reporting unit exceeds its carrying value and, therefore, we believe goodwill is properly valued as of the date of the filing of our 2004 Form 20-F. However, should new information arise, we may need to reassess goodwill and other intangible assets in light of the new information and we may then be required to take impairment charges related to goodwill and/or other intangible assets.
(k) Financing costs
Debt financing costs are included in other assets and are amortized to interest expense over the term of the related debt at a constant rate on the carrying amount.
(l) Derivative financial instruments
We enter into transactions in the normal course of business using a variety of financial instruments in order to hedge against exposures to fluctuating exchange and interest rates. We use derivative financial instruments to reduce exposure to fluctuations in foreign exchange rates and interest rates. Derivative instruments are contractual agreements whose value reflects price movements in an underlying asset or liability. We do not enter into derivative financial instruments for trading or speculative purposes. Our forward currency contracts do not qualify for hedge accounting under SFAS No. 133, "Accounting for Derivative Instruments in Hedging Activities" ("SFAS No. 133"), and are marked to market at each balance sheet date, with the resulting gains and losses recognized in income. Gains and losses on derivative financial instruments that qualify as fair value hedges under SFAS No. 133 are recognized as an offset to the related income or expense of the underlying hedged transaction. The carrying value of derivative financial instruments is reported within current assets or other current liabilities.
We fair value certain embedded derivative and freestanding warrants. Changes in their fair value are recorded in the income statement and their carrying value is recorded within current assets or current liabilities.
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(m) Revenue
Our revenues are derived from product revenue and contract revenue. Revenue is shown net of taxes, trade discounts, chargebacks and rebates.
Product Revenue — Product revenue includes: (i) the sale of products; (ii) royalties; (iii) the sales of product rights and related inventory (referred to as product disposals and product rationalizations); and (iv) product co-promotion, marketing and similar activities.
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i. | The sale of products consists of the sale of pharmaceutical drugs and diagnostic products, primarily to wholesalers and physicians. |
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ii. | We receive a percentage of revenue on certain products marketed by third parties as royalties. |
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iii. | Revenue from the sale of product rights and related inventory consists of the proceeds from the disposal of products, inventory and intellectual property less the unamortized cost of the related intangible assets. |
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iv. | Revenue from product co-promotion, marketing and similar activities consisted of the reimbursement of commercialization expenses from our risk-sharing arrangements with Pharma Marketing Ltd. (together with its subsidiary, "Pharma Marketing") and Autoimmune Diseases Research and Development Corp., Ltd. ("Autoimmune"). |
Revenue on the sale of products is recognized when title passes, net of applicable estimated discounts, sales returns, rebates and charge-backs. Other product revenues are recognized based on the terms of the applicable contract. Estimated sales returns, pursuant to rights of return granted to our customers, are reflected as a reduction of revenue in the same period that the related sales are recorded. The sales returns provisions are based on actual experience, although in certain situations, for example, a new product launch or at patent expiry, further judgment may be required. These amounts are included in other current liabilities (rebates) or deducted from trade receivables (other discounts).
Revenue is also recorded net of provision, made at the time of sale, for estimated cash discounts, rebates and charge-backs. We enter into contracts with certain managed care organizations to provide access to our products. Based on a managed care organization's market share performance and utilization of our products, the organization receives rebates from us. In addition, we are bound by certain laws and regulations to provide products at a discounted rate to Medicaid recipients. Medicaid rebates are paid to each state in the United States based on claims filed by pharmacies that provide our products to Medicaid recipients at the reduced rate.
Charge-backs are amounts paid to reimburse wholesalers for sales to third parties at reduced prices based on contracts that we negotiate. Cash discounts are provided to customers that pay their invoice within a certain time period.
Contract Revenue — Contract revenue arises from contracts to perform R&D services on behalf of clients or technology licensing and business ventures. Contract revenue is recognized when earned and non-refundable, and when we have no future obligation with respect to the revenue, in accordance with the terms prescribed in the applicable contract. Contract research revenue consists of payments or milestones arising from R&D activities performed by us on behalf of third parties.
U.S. Securities and Exchange Commission's ("SEC") Staff Accounting Bulletin No. 104, Revenue Recognition ("SAB 104"), provides guidance on revenue recognition. SAB 104 requires the deferral and amortization of up-front fees when there is a significant continuing involvement (such as an ongoing product manufacturing contract or joint development activities) by the seller after an asset disposal. We defer and amortize up-front license fees to income over the "performance period". The performance period is the period over which we expect to provide services to the licensee as determined by the contract provisions.
Accounting for milestone payments depends on the facts and circumstances of each contract. We apply the substantive milestone method in accounting for milestone payments. This method requires that substantive effort must have been applied to achieve the milestone prior to revenue recognition. If substantive effort has been applied, the milestone is recognized as revenue, subject to it being earned, non-refundable and not subject to future legal obligation. This requires an examination of the facts and circumstances of each contract. Substantive effort may be demonstrated by various factors, including the risks associated with achieving the milestone, the period of time over which effort was expended to achieve the milestone, the economic basis for the milestone payment and licensing arrangement and the costs and staffing necessary to achieve the milestone. It is expected that the substantive milestone method will be appropriate for most contracts. If we determine the substantive milestone method is not appropriate, then we apply the percentage-of-completion method to the relevant contract. This method recognizes as revenue the percentage of cumulative
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non-refundable cash payments earned under the contract, based on the percentage of costs incurred to date compared to the total costs expected under the contract. This is subject to the milestone being earned, non-refundable and not subject to future legal obligation.
(n) Advertising expenses
We expense the costs of advertising as incurred. Advertising expenses were $6.3 million in 2004 (2003: $7.3 million; 2002: $37.5 million).
(o) Research and development
R&D costs are charged to expense as incurred. Acquired in process research and development arising on business combinations is expensed on acquisition. Costs to acquire intellectual property, product rights and other similar intangible assets are capitalized and amortized on a straight-line basis over the estimated useful life of the asset or on the projected cash flow basis where it better reflects the product life cycle.
(p) Taxation
The provision for income taxes has been determined using the asset and liability approach of accounting for income taxes. Under this approach, deferred taxes represent the future tax consequences of events that have been recognized for financial reporting or income tax reporting purposes. Provision for income tax represents income taxes paid or payable for the current year plus the change in deferred taxes during the year. Deferred taxes result from differences between the financial and tax basis of our assets and liabilities, and are adjusted for changes in tax rates and tax laws when changes are enacted.
Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. We do not record a provision for income tax on undistributed earnings of foreign subsidiaries that we do not expect to repatriate in the foreseeable future.
We establish liabilities for possible assessments by taxing authorities resulting from known tax exposures. Such amounts represent a reasonable provision for taxes ultimately expected to be paid, and may need to be adjusted over time as more information becomes known.
(q) Discontinued operations, sales of businesses, and assets and liabilities held for sale
In accordance with SFAS No. 144, the results and gains or losses arising from discontinued operations are aggregated and included within one line in the income statement, "Net loss from discontinued operations." A discontinued operation is a component of an entity whose operations and cash flows can be clearly distinguished and have been or will be eliminated from the ongoing operations of the entity and the entity will not have any significant continuing involvement in the operations of the component after its disposal, such as continuing involvement, including ongoing supply arrangements or formulation activities.
Sales of businesses that do not constitute discontinued operations as defined above, are recorded on the face of the income statement. The reported gain is equal to proceeds received net of the carrying values of the business assets and liabilities being disposed of, transaction costs and the allocation of goodwill based on the relative fair value of the business to its reporting unit.
We categorize assets and liabilities as held for sale when all of the following are met:
| | |
| • | Management, having the authority to approve the action, commits to a plan to sell the asset; |
| | |
| • | The asset is available for immediate sale in its present condition, subject only to customary terms; |
| | |
| • | An active program to locate a buyer and other necessary actions required to complete the plan to sell the asset have been initiated; |
| | |
| • | The sale of the asset is probable, and transfer of the asset is expected to qualify for recognition as a completed sale, within one year; |
| | |
| • | The asset is being actively marketed for sale at a price that is reasonable in relation to its current fair value; and |
| | |
| • | Actions required to complete the plan indicate that it is unlikely that significant changes to the plan will be made or that the plan will be withdrawn. |
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(r) Accumulated other comprehensive income
Comprehensive income is comprised of our net income or loss and other comprehensive income/(loss) ("OCI"). OCI includes certain changes in stockholders' equity that are excluded from net income. Specifically, we include in OCI changes in the fair value of unrealized gains and losses on our available-for-sale securities and foreign currency translation adjustments. Comprehensive loss for the years ended December 31, 2004, 2003 and 2002 has been reflected in the Consolidated Statements of Stockholders' Equity and Other Comprehensive Income/(Loss).
(s) Foreign operations
Transactions in foreign currencies are recorded at the exchange rate prevailing at the date of the transaction. The resulting monetary assets and liabilities are translated into U.S. dollars at exchange rates prevailing at subsequent balance sheet dates, and the resulting gains and losses are recognized in the profit and loss account and, where material, separately disclosed.
The functional currency of most of our subsidiaries is U.S. dollars. For those subsidiaries with non-U.S. dollars functional currency, their assets and liabilities are translated using year-end rates and income is translated at average rates. The cumulative effect of exchange differences arising on consolidation of the net investment in overseas subsidiaries and associates are recognized as other comprehensive income in the Consolidated Statement of Shareholders' Equity and Other Comprehensive Income/(Loss).
(t) Stock-based compensation
We account for stock-based employee compensation using the intrinsic value method under Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees," and have adopted the disclosure-only provisions of Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation," ("SFAS No. 123"), as amended by SFAS No. 148, "Accounting for Stock-Based Compensation — Transition and Disclosures." Accordingly, no expense has been recognized for options granted to employees where the option exercise price is equal to the fair value of the underlying shares at the date of grant. When the exercise price of the option is less than the fair value of the underlying shares at the date of grant, the intrinsic value is recorded as compensation expense based on the graded vesting method over the vesting periods of the applicable stock purchase rights and stock options, generally four years. The graded vesting method provides for vesting of portions of the overall awards at interim dates and results in greater expense recorded in earlier years than under the straight-line method.
SFAS No. 123 requires the use of option pricing models. The Black-Scholes option-pricing model requires the input of highly subjective assumptions, including the option's expected life and the price volatility of the underlying stock. Since our employee stock options have characteristics significantly different from those of traded options and changes in the subjective input assumptions can materially affect the fair value estimate, we do not believe that the existing models necessarily provide a reliable single measure of the fair value of employee stock options.
Had compensation expense been determined based on the fair value at the grant date for all awards, consistent with the provisions of SFAS No. 123, reported pro forma net loss and net loss per share would have been as follows (in millions, except per share data):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Net loss as reported | | $ | (394.7 | ) | | $ | (506.1 | ) | | $ | (2,358.2 | ) |
Add: Intrinsic value method expense | | | 1.6 | | | | 1.1 | | | | 0.1 | |
Deduct: Fair value method expense | | | (49.4 | ) | | | (75.2 | ) | | | (127.5 | ) |
Pro-forma net loss | | $ | (442.5 | ) | | $ | (580.2 | ) | | $ | (2,485.6 | ) |
Basic and diluted loss per Ordinary Share: (1) | | | | | | | | | | | | |
As reported | | $ | (1.01 | ) | | $ | (1.42 | ) | | $ | (6.74 | ) |
Pro-forma | | $ | (1.13 | ) | | $ | (1.63 | ) | | $ | (7.11 | ) |
|
| |
(1) | There is no difference, for the periods presented, in weighted average number of ordinary shares used for basic and diluted net loss per ordinary share as the effect of all dilutive ordinary shares outstanding for each period was anti-dilutive. |
The estimated weighted-average fair value of the individual options granted during the years ended December 31, 2004, 2003 and 2002 was $9.93, $3.50 and $4.11, respectively, on the date of grant. The fair value of options granted was estimated using the Black-Scholes option-pricing model with the following weighted average assumptions:
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| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Risk-free interest rate | | | 3.36 | % | | | 1.02 | % | | | 1.62 | % |
Volatility | | | 61.0 | % | | | 99.3 | % | | | 91.0 | % |
Dividend yield | | | Nil | | | | Nil | | | | Nil | |
Expected life (years) | | | 4.3 | | | | 6.7 | | | | 5.9 | |
|
(u) Pensions and other employee benefit plans
We have two defined pension plans covering our employees based in Ireland. We account for pension benefit obligations and related costs in accordance with SFAS No. 87, "Employer's Accounting for Pensions." These plans are managed externally and the related pension costs and liabilities are assessed annually in accordance with the advice of a professionally qualified actuary. Two significant assumptions, the discount rate and the expected rate of return on plan assets, are important elements of expense and/or liability measurement. We evaluate these assumptions annually, with the assistance of an actuary. Other assumptions involve employee demographic factors such as retirement patterns, mortality, turnover and the rate of compensation increase. We use a December 31, 2004 measurement date. All plan assets and liabilities are reported as of that date. The cost or benefit of plan changes, which increase or decrease benefits for prior employee service is included in expense on a straight-line basis over the period the employee is expected to receive the benefits.
In addition, we have a number of other defined contribution benefit plans, primarily for employees outside of Ireland. The cost of providing these plans is expensed as incurred.
In December 2003, the FASB issued SFAS No. 132 (Revised 2003), "Employers' Disclosures about Pensions and Other Postretirement Benefits," which revises employers' disclosures about pension plans and other postretirement benefit plans. All provisions of this statement are effective for the year ended December 31, 2004. See Note 24 for further information on our pension and other employee benefit plans.
(v) Contingencies
In accordance with SFAS No. 5, "Accounting for Contingencies" ("SFAS No. 5"), we assess the likelihood of any adverse outcomes to contingencies, including legal matters, as well as the potential range of probable losses. We record accruals for such contingencies when it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. If an unfavorable outcome is probable, but the amount of the loss cannot be reasonably estimated, we estimate the range of probable loss and accrue the most probable loss within the range. If no amount within the range is deemed more probable, we accrue the minimum amount within the range. If neither a range of loss or a minimum amount of loss is estimable, then appropriate disclosure is provided, but no amounts are accrued. See Note 26 for further information.
3. Revenue
The composition of revenue for the years ended December 31, was as follows (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Product revenue | | $ | 404.4 | | | $ | 586.7 | | | $ | 742.4 | |
Contract revenue | | | 77.3 | | | | 98.9 | | | | 350.7 | |
Total revenue | | $ | 481.7 | | | $ | 685.6 | | | $ | 1,093.1 | |
|
Product revenue can be further analyzed as follows (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Retained products | | $ | 305.4 | | | $ | 274.2 | | | $ | 230.7 | |
Divested products (1) | | | 65.0 | | | | 278.5 | | | | 441.1 | |
Amortized revenue— Adalat/Avinza | | | 34.0 | | | | 34.0 | | | | 7.8 | |
Risk-sharing arrangements | | | — | | | | — | | | | 62.8 | |
Total product revenue | | $ | 404.4 | | | $ | 586.7 | | | $ | 742.4 | |
|
| |
(1) | Products described as "Divested Products" include products or businesses divested since the beginning of 2002. |
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Contract revenue can be further analyzed as follows (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
License fees | | $ | 17.6 | | | $ | 49.6 | | | $ | 234.7 | |
Risk-sharing arrangements | | | — | | | | — | | | | 37.2 | |
Research revenues/milestones | | | 59.7 | | | | 49.3 | | | | 78.8 | |
Total contract revenue | | $ | 77.3 | | | $ | 98.9 | | | $ | 350.7 | |
|
Included in license fee revenue is $Nil, $35.2 million and $203.8 million for 2004, 2003 and 2002, respectively, related to license fees earned from business ventures. There were no remaining unamortized license fees from the business ventures at December 31, 2004.
4. Earnings Per Share
Basic income/(loss) per share is computed by dividing the net income/(loss) for the period available to ordinary shareholders by the sum of the weighted average number of ordinary shares outstanding during the period. Diluted net income/(loss) per share is computed by dividing the net income/(loss) for the period by the weighted average number of ordinary shares oustanding and, when dilutive, adjusted for the effect of all dilutive potential ordinary shares, including stock options, warrants, and convertible debt securities on an as-if-converted basis.
The following table sets forth the computation for basic and diluted net income/(loss) per share:
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Basic and diluted net loss per ordinary share: | | | | | | | | | | | | |
Basic and diluted net loss per share from continuing operations | | $ | (1.06 | ) | | $ | (1.33 | ) | | $ | (6.20 | ) |
Basic and diluted net income/(loss) per share from discontinued operations | | | 0.05 | | | | (0.09 | ) | | | (0.54 | ) |
Basic and diluted net loss per ordinary share | | $ | (1.01 | ) | | $ | (1.42 | ) | | $ | (6.74 | ) |
|
The weighted average number of ordinary shares oustanding at December 31, 2004 was 390.1 million (2003: 356.0 million; 2002: 349.7 million). The potential effect of anti-dilutive stock options, warrants and convertible debt securities, for the year ended December 31, 2004 was 75.5 million shares (2003: 70.2 million shares; 2002: 26.2 million shares).
5. Restricted Cash
We had total restricted cash of $192.7 million at December 31, 2004 (2003: $33.1 million), of which $124.3 million is held by EPIL III and was reserved for the repayment of EPIL III Notes of $39.0 million due and repaid in full in March 2005. Following this debt repayment, the remaining cash in EPIL III can be used for general corporate purposes. Restricted cash at December 31, 2004 also includes $40.0 million reserved in escrow for our estimate of the ultimate cost to settle the shareholder class action lawsuit and $28.4 million of pledged cash to secure certain letters of credit. The restricted cash at December 31, 2003 of $33.1 million consisted of the cash held by EPIL III and pledged cash to secure certain letters of credit.
6. Accounts Receivable, Net
Our accounts receivable at December 31 of each year end consisted of the following (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Trade receivables | | $ | 47.0 | | | $ | 49.5 | |
Less amounts provided for doubtful accounts | | | (5.5 | ) | | | (11.6 | ) |
Trade receivables, net | | $ | 41.5 | | | $ | 37.9 | |
|
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7. Marketable Investment Securities
The following information on current marketable investment securities is presented in accordance with the requirements of SFAS No. 115 at December 31, 2004 and 2003 as follows (in millions):
| | | | | | | | | | | | | | |
| | Cost | | Gross Unrealized Gains | | Fair Value |
At December 31, 2004 | | | | | | | | | | | | |
Total trading securities | | $ | — | | | $ | — | | | $ | — | |
Available for sale securities | | | | | | | | | | | | |
Equity securities | | | 19.6 | | | | 11.7 | | | | 31.3 | |
Debt securities | | | 25.0 | | | | 9.2 | | | | 34.2 | |
Total available for sale securities | | | 44.6 | | | | 20.9 | | | | 65.5 | |
Total marketable investment securities | | $ | 44.6 | | | $ | 20.9 | | | $ | 65.5 | |
| | | | | | | | | | | | |
At December 31, 2003 | | | | | | | | | | | | |
Total trading securities | | $ | 74.8 | | | $ | 11.8 | | | $ | 86.6 | |
Available for sale securities | | | | | | | | | | | | |
Equity securities | | | 76.9 | | | | 96.3 | | | | 173.2 | |
Debt securities | | | 75.4 | | | | 14.2 | | | | 89.6 | |
Total available for sale securities | | | 152.3 | | | | 110.5 | | | | 262.8 | |
Total marketable investment securities | | $ | 227.1 | | | $ | 122.3 | | | $ | 349.4 | |
|
Unrealized gains on trading securities included in earnings for 2004, 2003 and 2002 totaled $Nil, $11.8 million and $0.8 million, respectively. The unrealized losses on trading securities included in earnings for 2004, 2003 and 2002 were $Nil, $Nil and $12.5 million, respectively.
The cash inflows arising from the sale and maturity of marketable investment securities were $178.9 million, $185.1 million and $222.6 million in 2004, 2003 and 2002, respectively. The net realized gains arising from the sale and maturity of marketable investment securities were $99.3 million, $68.7 million and $1.8 million in 2004, 2003 and 2002, respectively. The cash outflows arising from the purchase of marketable investment securities were $Nil, $2.1 million and $83.7 million in 2004, 2003 and 2002, respectively.
We have accounted for certain freestanding warrants and embedded derivatives in accordance with SFAS No. 133. The income effect of derivative fair value movements was a loss of $33.0 million, a gain of $26.1 million and a loss of $4.4 million in 2004, 2003, and 2002, respectively. Included in the 2004 impairment charge relating to investments held of $71.8 million (2003: $87.5 million; 2002: $1,006.0 million) was $Nil (2003: $Nil; 2002: $31.6 million) in relation to the impairment of SFAS No. 133 derivative instruments. These derivatives had a fair value of $1.4 million and $34.1 million at December 31, 2004 and 2003, respectively.
The impairment charge of $71.8 million for 2004 includes all other-than-temporary impairments at December 31, 2004. There are no investments with unrealized losses at December 31, 2004.
Non-current available-for-sale marketable securities, recorded at cost, were as follows at December 31 (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Equity securities | | $ | 20.8 | | | $ | 45.6 | |
Debt securities | | | 18.2 | | | | 132.9 | |
Other | | | — | | | | 14.4 | |
Total | | $ | 39.0 | | | $ | 192.9 | |
|
The cash inflows arising from the sale of non-current available-for-sale securities were $76.6 million, $53.1 million and $10.4 million in 2004, 2003 and 2002, respectively. The cash outflows arising from the purchase of non-current available-for-sale securities were $1.4 million, $11.8 million and $117.1 million for 2004, 2003 and 2002, respectively.
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8. Inventory
Product inventories at December 31, 2004 and 2003 consisted of the following (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Raw materials | | $ | 6.8 | | | $ | 17.1 | |
Work-in-process | | | 8.2 | | | | 21.3 | |
Finished goods | | | 14.0 | | | | 31.1 | |
Total inventory | | $ | 29.0 | | | $ | 69.5 | |
|
The decrease in inventories during 2004 primarily reflects the disposal of businesses and products.
9. Prepaid and Other Current Assets
Prepaid and other current assets at December 31 consisted of the following (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 (restated) |
Other receivables | | $ | 27.6 | | | $ | 34.6 | |
Insurance deposit (1) | | | 21.0 | | | | 18.8 | |
Prepayments | | | 25.0 | | | | 28.0 | |
Fair value of derivatives (2) | | | 5.0 | | | | 42.8 | |
Total prepaid and other current assets | | $ | 78.6 | | | $ | 124.2 | |
|
| |
(1) | Amount represents insurance program deposit balance received in January 2005. |
| |
(2) | The decrease in the fair value of derivatives during 2004 reflects the disposal of investments during the current year. |
10. Property, Plant and Equipment
| | | | | | | | | | | | | | |
| | Land & Buildings | | Plant & Equipment | | Total |
| | | | (in millions) | | |
Cost: | |
At January 1, 2004 | | $ | 254.6 | | | $ | 297.7 | | | $ | 552.3 | |
Additions | | | 30.0 | | | | 35.1 | | | | 65.1 | |
Disposals | | | (60.0 | ) | | | (25.2 | ) | | | (85.2 | ) |
At December 31, 2004 | | $ | 224.6 | | | $ | 307.6 | | | $ | 532.2 | |
Accumulated depreciation: | | | | | | | | | | | | |
At January 1, 2004 | | $ | (39.2 | ) | | $ | (144.0 | ) | | $ | (183.2 | ) |
Charged in year | | | (5.9 | ) | | | (33.2 | ) | | | (39.1 | ) |
Disposals | | | 14.3 | | | | 22.0 | | | | 36.3 | |
At December 31, 2004 | | $ | (30.8 | ) | | $ | (155.2 | ) | | $ | (186.0 | ) |
Net book value: December 31, 2004 | | $ | 193.8 | �� | | $ | 152.4 | | | $ | 346.2 | |
Net book value: December 31, 2003 | | $ | 215.4 | | | $ | 153.7 | | | $ | 369.1 | |
|
Property, plant and equipment disposals during 2004 primarily include the sale and leaseback of a building in San Diego, which is now accounted for as an operating lease.
The net book value of assets held under capital leases at December 31, 2004 amounted to $60.1 million (2003: $53.2 million) and related depreciation for the period amounted to $12.8 million (2003: $11.4 million; 2002: $13.9 million).
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11. Goodwill and Other Intangible Assets
| | | | | | | | | | | | | | |
| | Goodwill | | Other Intangible Assets | | Total |
| | (in millions) |
Cost: | |
At January 1, 2003 | | $ | 316.5 | | | $ | 1,266.5 | | | $ | 1,583.0 | |
Additions | | | — | | | | 12.2 | | | | 12.2 | |
Disposals | | | (41.9 | ) | | | (391.9 | ) | | | (433.8 | ) |
At December 31, 2003 | | $ | 274.6 | | | $ | 886.8 | | | $ | 1,161.4 | |
Additions | | | — | | | | 26.7 | | | | 26.7 | |
Disposals | | | (6.6 | ) | | | (104.1 | ) | | | (110.7 | ) |
At December 31, 2004 | | $ | 268.0 | | | $ | 809.4 | | | $ | 1,077.4 | |
Accumulated amortization: | | | | | | | | | | | | |
At January 1, 2003 | | $ | — | | | $ | (258.9 | ) | | $ | (258.9 | ) |
Charged in year | | | — | | | | (121.9 | ) | | | (121.9 | ) |
Disposals | | | — | | | | 127.2 | | | | 127.2 | |
At December 31, 2003 | | $ | — | | | $ | (253.6 | ) | | $ | (253.6 | ) |
Charged in year | | | — | | | | (84.5 | ) | | | (84.5 | ) |
Disposals | | | — | | | | 41.5 | | | | 41.5 | |
At December 31, 2004 | | $ | — | | | $ | (296.6 | ) | | $ | (296.6 | ) |
Net book value: December 31, 2004 | | $ | 268.0 | | | $ | 512.8 | | | $ | 780.8 | |
Net book value: December 31, 2003 | | $ | 274.6 | | | $ | 633.2 | | | $ | 907.8 | |
|
Other intangible assets consist primarily of patents, licenses and intellectual property. At December 31, 2004, the main components of the carrying value of patents and licenses were $220.0 million for Maxipime and Azactam, $97.5 million for the Alzheimer's disease intellectual property, $84.2 million for Prialt, $61.7 million for Verelan and $19.9 million for Tysabri.
Disposals of other intangible assets during 2004 primarily relate to the net intangible assets related to Zonegran (zonisamide) of $42.0 million and net intangible assets related to Frova of $22.2 million, both of which were sold during 2004.
At December 31, 2003, the main components of the carrying value of patents and licenses were $248.6 million for Maxipime and Azactam, $105.5 million for the Alzheimer's disease intellectual property, $89.2 million for Prialt, $68.8 million for Verelan, $22.9 for Frova, and $16.1 million for Tysabri.
Disposals of other intangible assets during 2003 primarily relate to the net intangible assets related to Sonata of $156.2 million and net intangible assets related to Roxane of $54.7 million, both of which were sold during 2003.
Amortization expense for the year ended December 31, 2004 amounted to $84.5 million (2003: $121.9 million; 2002: $129.3 million) and is recorded as cost of sales, selling, general and administrative expenses and R&D expenses in the Consolidated Statements of Operations, as it relates to the respective function.
As of December 31, 2004, our expected future annual amortization expense of other intangible assets was as follows (in millions):
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| | | | | | |
Year ending December 31, | | |
2005 | | $ | 101.8 | |
2006 | | | 93.5 | |
2007 | | | 93.5 | |
2008 | | | 38.5 | |
2009 | | | 23.4 | |
Total | | $ | 350.7 | |
|
12. Other Assets
Non-current other assets at December 31 consisted of the following (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Deferred financing costs | | $ | 42.6 | | | $ | 21.1 | |
Other | | | 12.4 | | | | 11.4 | |
Total other assets | | $ | 55.0 | | | $ | 32.5 | |
|
Deferred financing costs increased during 2004 due to the completion of our debt refinancing in November 2004. Please refer to Note 15 for additional information on our long-term and convertible debt.
13. Accrued and Other Current Liabilities
Accrued and other current liabilities at December 31 consisted of the following (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Payroll and related taxes | | $ | 58.6 | | | $ | 67.7 | |
Litigation accruals | | | 63.4 | | | | 12.0 | |
Accrued interest | | | 31.8 | | | | 21.1 | |
Clinical trial accruals | | | 27.7 | | | | 36.2 | |
Restructuring and other accruals | | | 18.0 | | | | 38.7 | |
Deferred rent | | | 17.3 | | | | 13.7 | |
Other accruals | | | 73.7 | | | | 147.8 | |
Total accrued and other current liabilities | | $ | 290.5 | | | $ | 337.2 | |
|
Restructuring and other accruals
In the early months of 2002, we suffered a number of setbacks in rapid succession, including the cessation of dosing in a Phase IIA clinical trial of AN-1792, an experimental immunotherapeutic that was under development for the treatment of Alzheimer's disease, the announcement of a profit warning and an investigation by the SEC. These disappointments ultimately led to a loss of confidence in Elan. To address these issues, we announced a recovery plan in July 2002 to restructure our business, assets and balance sheet in order to enable us to meet our financial commitments.
In February 2004, we announced the completion of our recovery plan. The principal elements and outcome of the recovery plan were:
| | |
| • | A focus on three core therapeutic areas: neurodegenerative diseases, autoimmune diseases and severe pain; |
| | |
| • | The divestment of financial assets, non-core businesses, products and assets targeting proceeds of $1.0 billion in the first nine months of the recovery plan and a further $500.0 million by the end of 2003. The total target of $1.5 billion was exceeded six months ahead of schedule, and by the end of the recovery plan gross consideration of $2.1 billion was achieved; |
| | |
| • | To meet our financial obligations. Contractual and potential future payments were reduced by $2.5 billion during the course of the recovery plan; |
| | |
| • | The implementation of a cost reduction program through headcount and infrastructure reductions and business rationalizations. At the completion of the recovery plan, headcount had been reduced to less than 2,000 from approximately 4,700 in July 2002; and |
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| | |
| • | A review of our business venture portfolio to conserve cash and reflect the reduced scope of our activities. As a result, we decided to restructure or terminate substantially all of our business ventures with the aim of substantially reducing or eliminating future cash outlays. All business ventures have been terminated, restructured or are now inactive. As a consequence, we do not expect to provide any additional financing to the business ventures and business venture parents. For additional information on the business ventures, please refer to Note 29. |
For additional information related to the recovery plan and the associated restructuring and other charges, please refer to Note 20 to the Consolidated Financial Statements.
The following table summarizes activities related to the restructuring and other charges (in millions):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Facilities | | Severance | | Pharma Marketing royalty rights | | Other exit costs | | Assets impairments | | Total |
Balance at December 31, 2002 | | $ | 19.7 | | | $ | 17.3 | | | $ | — | | | $ | — | | | $ | — | | | $ | 37.0 | |
Restructuring and other charges (1) | | | 12.7 | | | | 34.5 | | | | 297.6 | | | | 34.8 | | | | 71.6 | | | | 451.2 | |
Cash payments | | | (6.6 | ) | | | (34.2 | ) | | | (297.6 | ) | | | (34.8 | ) | | | — | | | | (373.2 | ) |
Non-cash charges | | | (4.7 | ) | | | — | | | | — | | | | — | | | | (71.6 | ) | | | (76.3 | ) |
Balance at December 31, 2003 | | $ | 21.1 | | | $ | 17.6 | | | $ | — | | | $ | — | | | $ | — | | | $ | 38.7 | |
Restructuring and other charges | | | 0.8 | | | | 3.0 | | | | — | | | | — | | | | — | | | | 3.8 | |
Cash payments | | | (4.7 | ) | | | (19.3 | ) | | | — | | | | — | | | | — | | | | (24.0 | ) |
Non-cash charges | | | (0.5 | ) | | | — | | | | — | | | | — | | | | — | | | | (0.5 | ) |
Balance at December 31, 2004 | | $ | 16.7 | | | $ | 1.3 | | | $ | — | | | $ | — | | | $ | — | | | $ | 18.0 | |
|
| |
(1) | The total restructuring and other charges of $451.2 million in 2003 includes $58.7 related to the costs associated with exit or disposal activity that involved discontinued operations, and such charges were included in the results of discontinued operations. The remaining charges of $392.5 million are included in restructuring and other charges, net (see Note 20). Costs incurred related to the shareholder litigation and SEC investigation did not relate to the restructuring and other activities under the recovery plan and so have been excluded from the table above. |
14. EPIL II Guarantee Provision
We had guaranteed the debt of EPIL II, to the extent that the investments held by it were insufficient to repay the debt when it fell due in June 2004. At December 31, 2003, we had recorded a provision of $344.5 million in respect of this guarantee. On June 28, 2004, the guaranteed notes of $450.0 million, together with accrued interest for the period from December 31, 2003 to June 28, 2004 of $21.5 million, were repaid. Of the aggregate payment of $471.5 million, $79.7 million was funded from the cash resources in EPIL II and through the sale of EPIL II's entire investment portfolio. We funded the balance of $391.8 million under our guarantee agreement. We recorded an expense of $47.1 million in 2004 (2003: $49.0 million; 2002: $295.4 million) arising from the guarantee to EPIL II noteholders and the insufficiency of EPIL II's assets to repay its debt.
In June 2000, we sold a portfolio of equity and debt securities to EPIL II, a wholly-owned, unconsolidated subsidiary. EPIL II was not consolidated as a subsidiary prior to June 2004. It qualified as a special purpose entity within the meaning of SFAS No. 125, as grandfathered under SFAS No. 140, as we had effected a true legal sale of the investments and had not retained control over such assets. Accordingly, the transfer of investments to EPIL II was treated as a sale of the assets at fair value and the related loan notes were not included as a liability. We did not expense the related interest charge in the income statement. We recorded a gain of $39.2 million arising from the disposal of investments to EPIL II in June 2000.
We held a retained interest in EPIL II through our ownership of the retained beneficial interest (100% of the common stock). The retained beneficial interest entitled us to any residual proceeds in EPIL II after repayment of the EPIL II Notes. Pursuant to the Stock Pledge Agreement, we had pledged the common stock in EPIL II to the noteholders of EPIL II. On December 31, 2003, the estimated fair value of our retained interest in EPIL II was $Nil. The holders of the loan notes had control of key voting rights, such as the right to approve the appointment of directors of EPIL II and the right to approve amendments to the Memorandum of Association and By-Laws of EPIL II. The board of directors of EPIL II was independent and was comprised of a majority of independent directors and one director appointed by us. In accordance with the organizational documents, EPIL II could dispose of investments upon maturity of its loan notes.
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Upon the maturity of the loan notes due 2004, if there were more than sufficient investments to repay the loan notes, the organizational documents of EPIL II did not contain provisions concerning the selection of investments, or the amount of investments, to be disposed of. In this situation, any decision as to which assets to dispose of was made by the board of directors of EPIL II. When the loan notes of EPIL II were repaid, the Stock Pledge Agreement terminated and we were entitled to the residual proceeds, if any, through ownership of the common stock in EPIL II. We did not have a call option or similar unilateral legal right over the transferred investments. We had provided a direct guarantee to the holders of the loan notes of EPIL II for the repayment of the loan notes and the payment of any unpaid interest. In the event that EPIL II did not meet its obligations to pay amounts due to the noteholders, the noteholders could call upon our guarantee.
Our accounting policy was to allocate the previous carrying amount of the investments transferred, between the investments transferred and the retained interest based on their relative fair values on the date of transfer. The fair value of a retained interest, both for initial and subsequent measurement, was calculated as the fair value of the qualifying special purpose entity's assets less the fair value of its liabilities. For disclosure purposes, the fair value of the assets of EPIL II was estimated using established financial methodologies, including quoted market prices, where available, and takes into account the time value of money. The fair value of investments in private entities and non-traded securities of public entities is typically measured by valuation methodologies such as option-pricing models and valuations achieved in recent private placements by the investee. The key assumptions used in measuring the fair value of our retained interest in EPIL II was common stock prices for equity-based assets and the discount rate used for debt-based assets. The fair value of the liabilities of EPIL II was measured as the total amount outstanding under its loan notes, including accrued but unpaid interest (if any), and takes into account the time value of money. The fair value of the guarantee was measured as de minimis on the transfer date. The guarantee was subsequently accounted for, under U.S. GAAP, as a loss contingency in accordance with the requirements of SFAS No. 5. This required that we record a charge under the guarantee if it was probable that a payment would be made under the guarantee to the EPIL II noteholders.
Our retained interest in EPIL II had a fair value of $Nil on the transfer date. We were carrying the common stock of EPIL II at cost, as it did not qualify as a debt security or a debt-like security as defined in SFAS No. 115.
We provided services such as bookkeeping and administration, monitoring, administering compliance with applicable laws and regulation and custodian service to EPIL II. Such services were for the benefit of EPIL II. All compensation paid represents an arms-length price for those services. In 2004, we received a fee of $0.4 million (2003: $0.8 million; 2002: $0.8 million) for providing these services to EPIL II.
15. Long-Term and Convertible Debt
Long-term and convertible debt at December 31, 2004 and 2003 consisted of the following (in millions):
| | | | | | | | | | | | | | |
| | Due | | 2004 | | 2003 |
EPIL III Notes | | | 2005 | | | $ | — | | | $ | 390.0 | |
7.25% senior notes ("Athena Notes") | | | 2008 | | | | 650.0 | | | | 650.0 | |
6.5% convertible notes | | | 2008 | | | | 460.0 | | | | 460.0 | |
7.75% senior notes ("7.75% Notes") | | | 2011 | | | | 850.0 | | | | — | |
Senior floating rate notes ("Floating Rate Notes") | | | 2011 | | | | 300.0 | | | | — | |
Total long term and convertible debt | | | | | | $ | 2,260.0 | | | $ | 1,500.0 | |
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Athena Notes
In February 2001, Athena Neurosciences Finance, LLC ("Athena Finance"), an indirect wholly-owned subsidiary, issued $650.0 million in aggregate principal amount of Athena Notes due February 2008 at a discount of $2.5 million. The Athena Notes are senior, unsecured obligations of Athena Finance and are fully and unconditionally guaranteed on a senior unsecured basis by Elan Corporation, plc and certain of our subsidiaries. Issuance costs associated with the financing amounted to $8.3 million. Interest is paid in cash semi-annually.
On January 14, 2002, we entered into an interest rate swap to convert our fixed rate interest obligations for $100.0 million of the Athena Notes to variable rate interest obligations. The swap had a fair value gain of $3.6 million at December 31, 2004 (2003: $8.5 million). On November 22, 2004, we entered into an interest rate swap to convert an additional $200.0 million of this debt to variable rate interest obligations. The swap had a fair value loss of $0.9 million at December 31, 2004.
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6.5% Convertible Notes
In November 2003, we completed the offering and sale of $460.0 million in aggregate principal amount of 6.5% Convertible Notes issued by Elan Capital Corporation, an indirect wholly-owned subsidiary, and guaranteed by Elan Corporation, plc. The 6.5% Convertible Notes mature on November 10, 2008.
Holders of the 6.5% Convertible Notes have the right to convert the notes into fully-paid American Depository Shares ("ADSs") at a conversion price of $7.42 at any time up to November 10, 2008 or seven trading days preceding the date of redemption if the notes are called for redemption.
We may, at any time after December 1, 2006, redeem all or part of the 6.5% Convertible Notes then outstanding at par, with interest accrued to the redemption date provided that, within a period of 30 consecutive trading days ending five trading days prior to the date on which the relevant notice of redemption is published, the official closing price per share of the ADSs on the NYSE for 20 trading days shall have been at least 150% of the conversion price deemed to be in effect on each of such trading days. Interest is paid in cash semi-annually.
7.75% Notes
In November 2004, we completed the offering and sale of $850.0 million in aggregate principal amount of 7.75% Notes due November 15, 2011 issued by Elan Finance plc. Elan Corporation, plc and certain of our subsidiaries have guaranteed the 7.75% Notes. At any time prior to November 15, 2008, we may redeem the 7.75% Notes, in whole, but not in part, at a price equal to 100% of their principal amount plus a make-whole premium plus accrued and unpaid interest. We may redeem the 7.75% Notes, in whole or in part, beginning on November 15, 2008 at an initial redemption price of 103.875% of their principal amount plus accrued and unpaid interest. In addition, at any time after February 17, 2006 and on or prior to November 15, 2007, we may redeem up to 35% of the 7.75% Notes using the proceeds of certain equity offerings at a redemption price of 107.75% of the principal.
Floating Rate Notes
In November 2004, we also completed the offering and sale of $300.0 million in aggregate principal amount of Floating Rate Notes due November 15, 2011, also issued by Elan Finance plc. The Floating Rate Notes bear interest at a rate, adjusted quarterly, equal to the three-month London Interbank Offer Rate ("LIBOR") plus 4.0%, except the first interest payment, which bears interest at a rate equal to six-month LIBOR plus 4.0%. Elan Corporation, plc, and certain of our subsidiaries have guaranteed the Floating Rate Notes. At any time prior to November 15, 2006, we may redeem the Floating Rate Notes, in whole, but not in part, at a price equal to 100% of their principal amount plus a make-whole premium plus accrued and unpaid interest. We may redeem the Floating Rate Notes, in whole or in part, beginning on November 15, 2006 at an initial redemption price of 102% of their principal amount plus accrued and unpaid interest. In addition, at any time after February 17, 2006 and on or prior to November 15, 2007, we may redeem up to 35% of the Floating Rate Notes using the proceeds of certain equity offerings at a redemption price of 100% of the principal amount plus a premium equal to the interest rate per annum on the Floating Rate Notes, plus accrued and unpaid interest thereon.
EPIL III Notes
In March 2001, we transferred a portfolio of equity and debt securities to a special purpose entity, EPIL III, a wholly owned and consolidated subsidiary. EPIL III issued $200.0 million in aggregate principal amount of Series C Guaranteed Notes in a private placement to a group of financial institutions. In addition, EPIL III issued $160.0 million in aggregate principal amount of Series A Guaranteed Notes and $190.0 million of Series B Guaranteed Notes, in exchange for all outstanding guaranteed notes issued in June 1999 by Elan Pharmaceutical Investments, Ltd ("EPIL"). We fully and unconditionally guaranteed the Series B Guaranteed Notes and Series C Guaranteed Notes on a subordinated basis. The Series A Guaranteed Notes bore interest at the rate of 8.43% per annum. The Series B Guaranteed Notes bore interest at the rate of 8.43% per annum through June 2002 and 7.72% per annum thereafter. The Series C Guaranteed Notes bear interest at the rate of 7.62% per annum.
In 2001, EPIL III paid cash of $106.0 million to us and also exchanged the EPIL III Series A and Series B Guaranteed Notes for all outstanding EPIL guaranteed notes as consideration for the portfolio of investments transferred to it. Other than these payments and a payment of $0.8 million (2003: $0.8 million, 2002: $0.8 million) for administration services, there were no other cash flows between EPIL III and us in 2004, 2003 or 2002. The remaining investments and cash in
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EPIL III are held as security against the EPIL III Series B Guaranteed Notes and the Series C Guaranteed Notes. These assets were not available for distribution outside EPIL III prior to repayment of the EPIL III Notes. The investments and cash had a fair value of $125.3 million (principally cash of $124.3 million), and a carrying value of $125.3 million, at December 31, 2004. EPIL III used the funds to repay the remaining EPIL III Notes of $39.0 million in March 2005. Issuance costs associated with the EPIL III Notes amounted to $6.1 million.
In June 2002, EPIL III disposed of securitized investments to Shelly Bay, an entity established by Elan, in order to repay the $160.0 million in the aggregate principal amount of its Series A Guaranteed Notes which matured on June 29, 2002. Shelly Bay financed the entire purchase price of the investments through borrowings under a non-recourse bank loan facility which we guaranteed. Elan made a cash payment of $141.6 million to satisfy its obligation under the guarantee.
In November 2004, through our wholly owned subsidiary, Elan International Services, Ltd. , we completed a cash tender offer to purchase $351.0 million of the EPIL III Series B and C Guaranteed Notes.
The net interest expense related to all of the convertible notes and long-term debt for the years ended December 31, 2004, 2003 and 2002 is as follows (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 (restated) | | 2002 (restated) |
Interest expense: | | | | | | | | | | | | |
Interest on Athena Notes | | $ | 47.2 | | | $ | 47.2 | | | $ | 47.2 | |
Interest on 6.5% Convertible Notes | | | 29.9 | | | | 4.2 | | | | — | |
Interest on 7.75% Notes | | | 8.4 | | | | — | | | | — | |
Interest on Floating Rate Notes | | | 2.5 | | | | — | | | | — | |
Interest on EPIL III Notes (1) | | | 33.1 | | | | 30.0 | | | | 37.6 | |
Financing charges | | | 5.5 | | | | 19.4 | | | | 12.9 | |
Foreign exchange loss | | | 3.0 | | | | 8.9 | | | | 2.6 | |
Interest on Liquid Yield Option Notes ("LYONs") | | | — | | | | 19.2 | | | | 31.7 | |
Other | | | 1.2 | | | | (0.2 | ) | | | 5.4 | |
Interest expense | | $ | 130.8 | | | $ | 128.7 | | | $ | 137.4 | |
Interest income: | | | | | | | | | | | | |
Bank interest | | $ | (12.5 | ) | | $ | (11.0 | ) | | $ | (32.4 | ) |
Investment interest | | | (6.8 | ) | | | (10.2 | ) | | | (33.2 | ) |
Swap interest | | | (3.7 | ) | | | (3.7 | ) | | | (1.1 | ) |
Interest income | | $ | (23.0 | ) | | $ | (24.9 | ) | | $ | (66.7 | ) |
Net interest expense | | $ | 107.8 | | | $ | 103.8 | | | $ | 70.7 | |
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| |
(1) | Includes a consent and early tender fee of $6.4 million in 2004 (2003: $Nil; 2002: $Nil) |
Covenants
The agreements governing some of our outstanding convertible and long-term indebtedness contain various restrictive covenants that limit our financial and operating flexibility. The covenants do not require us to maintain or adhere to any specific financial ratios, however, they do restrict our ability to, among other things:
| | |
| • | Enter into certain transactions with related parties; |
| | |
| • | Enter into certain types of investment transactions; |
| | |
| • | Engage in certain asset sales or sale and leaseback transactions; |
| | |
| • | Consolidate, merge with, or sell substantially all our assets to, another entity. |
The breach of any of these covenants may result in a default under the applicable agreement, which could result in the indebtedness under the agreement becoming immediately due and payable and may result in a default under our other indebtness subject to cross acceleration provisions.
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16. Fair Value of Financial Instruments
Fair value is the amount at which a financial instrument could be exchanged in an arm's-length transaction between informed and willing parties, other than in a forced or liquidation sale. Cash and cash equivalents and marketable securities are held at fair value on the Consolidated Balance Sheets.
Debt Instruments
The fair value of debt instruments was as follows (in millions):
| | | | | | | | | | | | | | | | | | |
| | At December 31, 2004 | | At December 31, 2003 |
| | Carrying Value | | Fair Value | | Carrying Value | | Fair Value |
EPIL III Notes (1) | | $ | 39.0 | | | $ | 39.0 | | | $ | 390.0 | | | $ | 390.0 | |
Athena Notes | | | 650.0 | | | | 679.3 | | | | 650.0 | | | | 600.4 | |
6.5% Convertible Notes | | | 460.0 | | | | 1,754.9 | | | | 460.0 | | | | 594.1 | |
7.75% Notes | | | 850.0 | | | | 909.5 | | | | — | | | | — | |
Floating Rate Notes | | | 300.0 | | | | 317.3 | | | | — | | | | — | |
Total convertible debt and guaranteed notes | | $ | 2,299.0 | | | $ | 3,700.0 | | | $ | 1,500.0 | | | $ | 1,584.5 | |
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| |
(1) | The fair value of the EPIL III Notes approximates the carrying value as EPIL III repaid the remaining guaranteed notes of $39.0 million in March 2005. The EPIL III Notes are included within current liabilities in the Consolidated Balance Sheet. See Note 15 for additional information. |
The fair values of the debt instruments has decreased significantly with our voluntary suspension of Tysabri in February 2005 from $3,700.0 million at December 31, 2004 to $1,769.0 million at March 31, 2005 primarily due to the decrease in the option value of the 6.5% Convertible Notes.
Derivative Instruments
The fair value of derivative instruments were as follows (in millions):
| | | | | | | | | | | | | | | | | | |
| | At December 31, 2004 | | At December 31, 2003 |
| | Contract Amount | | Fair Value | | Contract Amount | | Fair Value |
Forward contracts: | | | | | | | | | | | | | | | | |
United States Dollar forward contracts | | $ | 9.4 | | | $ | (0.4 | ) | | $ | — | | | $ | — | |
Euro forward contracts | | | 9.0 | | | | 1.2 | | | | — | | | | — | |
Swap contracts: | | | | | | | | | | | | | | | | |
Interest rate swap—January 2002 | | $ | 100.0 | | | $ | 3.6 | | | $ | 100.0 | | | $ | 8.5 | |
Interest rate swap—November 2004 | | | 200.0 | | | | (0.9 | ) | | | — | | | | — | |
| | | | | | | | | | | | | | | | |
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Forward contracts
At December 31, 2004, we had entered into a number of forward foreign exchange contracts at various rates of exchange in the normal course of business. The United States Dollar forward contracts require us to sell Japanese Yen for United States Dollars on various dates through December 2005. The Euro forward contracts require us to sell United States Dollars for Euro on various dates through December 2005.
Swaps
On January 14, 2002, we entered into an interest rate swap to convert our 7.25% fixed rate interest obligations on $100.0 million of the Athena Notes to variable rate interest obligations. On November 22, 2004, we entered into an interest rate swap to convert an additional $200.0 million of this debt to variable rate interest obligations. These swaps qualify as fair value hedges.
17. Deferred Revenue
Deferred revenue consists of a current portion of $55.8 million and a non-current portion of $54.6 million (2003: $61.5 million, $93.3 million, respectively). The principal component of total deferred revenue is the remaining unamortized
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revenue related to the licensing of rights to our generic form of Adalat CC with Watson Pharmaceutical, Inc. ("Watson") and the restructuring of our Avinza (morphine sulfate extended-release) license agreement with Ligand Pharmaceuticals, Inc. ("Ligand"). The generic Adalat CC transaction was completed in 2002. We received $45.0 million in cash from Watson. The Avinza transaction was also completed in 2002. We received a cash payment of $100.0 million from Ligand, in return for a reduction in the on-going royalty rate from the previous level of 30% of net sales of Avinza in the United States and Canada to approximately 10%. The remaining unamortized revenue on these products of $69.2 million will be recognized as revenue through June 2007 (generic Adalat CC, $22.5 million) and November 2006 (Avinza, $46.7 million), reflecting our on-going involvement in the manufacture of these products.
18. Provision for Income Taxes
The following table sets forth the details of income taxes for the years ended December 31 (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Irish corporation tax—current | | $ | 1.8 | | | $ | 9.7 | | | $ | 2.3 | |
Foreign taxes—current | | | (2.3 | ) | | | (32.5 | ) | | | 5.7 | |
Income tax expense/(benefit) on continuing operations | | $ | (0.5 | ) | | $ | (22.8 | ) | | $ | 8.0 | |
Tax expense/(benefit) on discontinued operations | | $ | — | | | $ | 0.8 | | | $ | 11.8 | |
Tax expense/(benefit) reported in shareholders' equity related to: | | | | | | | | | | | | |
Exercise of stock options | | $ | (2.7 | ) | | $ | — | | | $ | — | |
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Current tax, including Irish corporation tax and foreign taxes, is provided on our taxable profits, using the tax rates and laws that have been enacted or substantially enacted by the balance sheet date. In each of the three years ended December 31, 2004, 2003 and 2002, substantially all of our income in Ireland was exempt from taxation by virtue of relief granted on income derived from patents or due to tax losses incurred. The total tax benefit of $0.5 million and $22.0 million for 2004 and 2003, respectively, reflect tax at standard rates in the jurisdictions in which we operate, income derived from Irish patents, foreign withholding tax and the availability of tax losses.
Reflecting the exempt nature of certain Irish income and the availability of tax losses in Ireland and foreign operations, there was no deferred tax expense for the above years.
Irish and overseas taxation have been provided at current rates on the profits earned for the periods covered by the Consolidated Financial Statements.
For the years ended December 31, a reconciliation of the expected tax expense/(benefit) on continuing operations (computed by applying the standard Irish tax rate to (losses)/profits before tax) to the actual tax expense/(benefit) is as follows (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Irish standard tax rate | | | 12.5 | % | | | 12.5 | % | | | 16.0 | % |
Taxes at the Irish standard rate | | $ | (51.8 | ) | | $ | (62.2 | ) | | $ | (346.0 | ) |
Irish income at reduced rates | | | (10.4 | ) | | | (6.9 | ) | | | (18.4 | ) |
Foreign income at rates other than the Irish standard rate | | | (44.3 | ) | | | (82.5 | ) | | | (9.4 | ) |
Losses creating no tax benefit | | | 105.8 | | | | 127.3 | | | | 378.2 | |
Share of investments accounted for under the equity method (including elimination of revenue) | | | 0.2 | | | | 1.5 | | | | 3.4 | |
Other | | | — | | | | — | | | | 0.2 | |
Income tax expense/(benefit) | | $ | (0.5 | ) | | $ | (22.8 | ) | | $ | 8.0 | |
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For the years ended December 31, the distribution of income/(loss) from continuing operations before provision for income taxes by geographical area was as follows (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Loss from continuing operations before provision for income taxes: | | | | | | | | | | | | |
Ireland | | $ | (126.9 | ) | | $ | (307.5 | ) | | $ | (925.0 | ) |
Foreign | | | (287.3 | ) | | | (189.9 | ) | | | (1,236.6 | ) |
Loss from continuing operations before provision for income taxes | | $ | (414.2 | ) | | $ | (497.4 | ) | | $ | (2,161.6 | ) |
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Deferred Taxation
The deferred taxation provision under U.S. GAAP is calculated in accordance with the requirements of SFAS No. 109, "Accounting for Income Taxes," ("SFAS No. 109").
The full potential amounts of deferred taxation and amounts accounted for in our balance sheet comprised the following deferred tax assets and liabilities at December 31 (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Deferred taxation liabilities: | | | | | | | | |
Property, plant and equipment | | $ | (88.0 | ) | | $ | (45.8 | ) |
Intangible asset on acquisition | | | (4.1 | ) | | | (52.6 | ) |
Deferred interest | | | — | | | | (2.9 | ) |
Total deferred taxation liabilities | | $ | (92.1 | ) | | $ | (101.3 | ) |
Deferred taxation assets | | | | | | | | |
Net operating losses | | $ | 354.8 | | | $ | 232.3 | |
Deferred interest | | | 139.8 | | | | 92.2 | |
Capitalized items | | | 87.8 | | | | 128.6 | |
Tax credits | | | 77.1 | | | | 83.9 | |
Reserves/provisions | | | 21.0 | | | | 70.3 | |
Fixed assets | | | 0.7 | | | | — | |
Other | | | 1.8 | | | | 2.6 | |
Total deferred taxation assets | | $ | 683.0 | | | $ | 609.9 | |
Valuation allowance | | $ | 590.9 | | | $ | 508.6 | |
Deferred tax asset/(liability) | | $ | — | | | $ | — | |
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We apply SFAS No. 109, which requires the asset and liability method of accounting for income taxes. Under this method, 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 carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled and when net operating losses are expected to be utilized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance has been established in respect of those deferred tax assets to the extent it is deemed more likely than not that the asset will not be realized in the future.
The valuation allowance recorded against the deferred tax assets as of December 31, 2004 was $590.9 million. The net change in the valuation allowance for 2004 was an increase of $82.3 million (2003: increase of $77.0 million; 2002: increase of $29.6 million).
We expect approximately $137.1 million of the valuation allowance at December 31, 2004 to be applied directly to contributed capital under U.S. GAAP when deferred tax assets associated with certain stock option exercises are recognized. We have adjusted our net operating losses to reflect the amounts expected to be recognized on a probable basis. In 2004, we have credited $2.7 million to shareholders' equity to reflect recognition of United States state tax and U.K. corporation tax benefits from the utilization of stock option deductions.
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At December 31, 2004 certain U.S. subsidiaries had net operating loss carryovers for federal income tax purposes of approximately $503.9 million and for state income tax purposes of approximately $219.8 million. The federal net operating losses will expire from 2009 to 2024. The state net operating losses expire from 2005 to 2023, with $142.0 million of the state net operating losses expiring in 2013 to 2014 to the extent they are not utilized. In addition, at December 31, 2004, certain U.S. subsidiaries had federal research and orphan drug credit carryovers of $58.0 million, which will expire from 2007 through 2022 and state credit carryovers of $29.5 million, mostly research credits, of which $29.3 million can be carried to subsequent tax years indefinitely, and $0.2 million will expire from 2010 to 2011 to the extent they are not utilized. We may have had "changes in ownership" as described in the U.S. Internal Revenue Code Section 382. Consequently, utilization of federal and state net operating losses and credits may be subject to certain annual limitations.
At December 31, 2004 certain of our non-U.S. subsidiaries had net operating loss carryovers for income tax purposes of $1,303.1 million. Approximately $1,269.4 million of these losses arose in Ireland and can be carried forward indefinitely but are limited to the same trade/trades. The remaining loss carryovers have arisen in the U.K. and The Netherlands. These remaining loss carryovers can be carried forward indefinitely, subject to local rules.
No taxes have been provided for the unremitted and untaxed earnings of our overseas subsidiaries as these are considered permanently employed in the business of these companies. Cumulative unremitted earnings of overseas subsidiaries and related undertakings totaled approximately $1,237.4 million at December 31, 2004. Unremitted earnings may be liable to overseas taxes or Irish taxation if they were to be distributed as dividends. It is impracticable to determine at this time the potential amount of additional tax due upon remittance of earnings.
19. Leases
We lease certain of our facilities under noncancelable operating lease agreements that expire at various dates through 2016. The major components of our operating leases are as described below.
In August 1998, we entered into an agreement for the lease of four buildings located in South San Francisco, California. These buildings are utilized for R&D, administration and other corporate functions. The initial lease period expires in December 2012 with an option to renew for two additional five-year periods.
In May 2001, we entered into a lease agreement for our R&D facility located in King of Prussia, Pennsylvania. This lease agreement expires in April 2006 with an option to renew for an additional five-year period.
In January 2004, we entered into a lease agreement for our R&D, sales and administrative facility at Lusk Campus, San Diego, California. This lease expires in January 2007 with an option to renew for an additional five-year period.
In September 2004, we entered into a lease agreement for our new corporate headquarters located in the Treasury Building, Dublin, Ireland. This lease expires in July 2014, with an option to renew for two additional ten-year periods.
We recorded rental expense under operating leases of $19.0 million in 2004 (2003: $18.7 million; 2002: $23.5 million), net of sublease income of $0.8 million in 2004 (2003: $0.5 million; 2002: $0.1 million). As of December 31, 2004, our future minimum rental commitments for operating leases with non-cancelable terms in excess of one year are as follows (in millions):
| | | | | | |
Due in: | | | | |
2005 | | $ | 18.4 | |
2006 | | | 18.1 | |
2007 | | | 12.7 | |
2008 | | | 14.6 | |
2009 | | | 19.5 | |
Later years | | | 66.8 | |
Total | | $ | 150.1 | |
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As of December 31, 2004, we had obligations under capital leases as follows (in millions):
| | | | | | |
2005 | | $ | 6.9 | |
2006 | | | 6.6 | |
2007 | | | 3.1 | |
2008 and thereafter | | | — | |
Total gross payments | | $ | 16.6 | |
Less: finance charges included above | | $ | (1.0 | ) |
Total net capital lease obligations | | $ | 15.6 | |
|
In prior years, we disposed of plant and equipment and subsequently leased them back and also entered into an arrangement with a third party bank, the substance of which allows us to require a net settlement of our obligations under the leases. The assets and liabilities of these previous sale and leaseback transactions have been offset in the Consolidated Financial Statements in the amount of $64.3 million at December 31, 2004 (2003: $63.8 million).
20. Restructuring and Other Charges, Net
The principal items classified as restructuring and other charges include asset impairments, purchase of royalty rights, severance and relocation costs, and losses incurred from litigation or regulatory actions including shareholder class action litigation and the SEC investigation (see also Note 13).
Restructuring and other charges for the years ended December 31 consisted of (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
(A) Shareholder litigation and SEC investigation | | $ | 56.0 | | | $ | 10.7 | | | $ | 22.6 | |
(B) Severance, relocation and exit costs | | | 3.0 | | | | 29.7 | | | | 77.8 | |
(C) Purchase of royalty rights | | | — | | | | 297.6 | | | | 121.0 | |
(D) EPIL II/III waiver fee | | | — | | | | 16.8 | | | | — | |
(E) Asset impairments | | | — | | | | 32.6 | | | | 266.1 | |
(F) Gain on repurchase of LYONs | | | — | | | | (1.6 | ) | | | (37.7 | ) |
(G) Other litigation provisions | | | — | | | | — | | | | 18.0 | |
(H) 401(K) rescission offer | | | — | | | | — | | | | 13.5 | |
Other | | | 0.8 | | | | 17.4 | | | | 19.4 | |
Total restructuring and other charges, net | | $ | 59.8 | | | $ | 403.2 | | | $ | 500.7 | |
|
(A) Shareholder litigation and SEC investigation
During 2004, we recorded $56.0 million (2003: $10.7 million; 2002: $22.6 million) related to litigation provisions and costs related to the SEC investigation and shareholder class action lawsuit. The expense recorded in 2004 arose primarily as a result of a $55.0 million provision made in relation to settlement of the SEC investigation ($15.0 million) and the related shareholder class action lawsuit ($40.0 million).
We and certain of our former and current officers and directors were named as defendants in a putative class action filed in early 2002 alleging that our Consolidated Financial Statements were not prepared in accordance with generally accepted accounting principles, and that the defendants disseminated materially false and misleading information concerning our business and financial results, with respect to our investments in certain business ventures and business venture parents and the license fees and research revenues received from the business ventures; the accounting for proceeds from our sale of certain product lines and disclosure concerning those sales; the accounting for certain risk-sharing arrangements that we entered into and disclosure concerning those arrangements; the accounting for certain qualified special purpose entities and disclosure concerning those entities; the disclosure of compensation of certain officers; and certain alleged related-party transactions. We agreed to settle the action in October 2004. Under the proposed class action settlement, all claims against us and the other named defendants would be dismissed with no admission or finding of wrongdoing on the part of any defendant. The principal terms of the proposed settlement provide for an aggregate cash payment to class members of $75.0 million, out of which the court would award attorneys' fees to plaintiffs' counsel, and $35.0 million would be paid by our insurance carrier. The settlement is subject to final court approval.
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We were also the subject of an investigation by the SEC's Division of Enforcement. We provisionally settled the investigation in October 2004. The SEC formally approved the settlement in February 2005. Under the agreement reached with the SEC, we neither admitted nor denied the allegations contained in the SEC's civil complaint, which included allegations of violations of certain provisions of the federal securities laws. The settlement contains a final judgment restraining and enjoining us from future violations of these provisions. In addition, under the final settlement, we paid a civil penalty of $15.0 million. In connection with the settlement, we were not required to restate or adjust any of our historical financial results or information.
The expense incurred in 2003 and 2002 relates to legal expenses incurred on the SEC investigation and shareholder class action lawsuit.
For additional information on pending litigation, please refer to Note 26 to the Consolidated Financial Statements.
(B) Severance, relocation and exit costs
During 2004, we incurred severance, relocation and exit costs arising from the implementation of our recovery plan of $3.0 million (2003: $29.7 million; 2002: $77.8 million). The recovery plan, which commenced in July 2002 and was completed in February 2004, involved the restructuring of our businesses, assets and balance sheet. These expenses arose from a reduction in the scope of our activities and a reduction in employee numbers.
(C) Purchase of royalty rights
During 2003 and 2002, we repurchased royalty rights related to certain of our current and former products from Pharma Marketing and Autoimmune, respectively. For additional information on the purchase of royalty rights from Pharma Marketing and Autoimmune, please refer to Note 30 to the Consolidated Financial Statements.
(D) EPIL II/III waiver fee
In November 2003, we successfully completed a private offering of $460.0 million in aggregate principal amount of 6.5% Guaranteed Convertible Notes due 2008. In connection with this offering, we paid a waiver fee of $16.8 million to the holders of the EPIL II and EPIL III notes.
(E) Asset impairments and write-off
During 2004, we recorded $Nil (2003: $32.6 million; 2002: $266.1 million) related to the impairment of tangible and intangible assets. As part of our recovery plan, we identified a range of businesses and products that we intended to sell in the near term. In many cases, we had received indicative offers for these assets and wrote-down the assets to their fair value. In other cases, the impairment arose because of changes to the forecasted profitability of these assets.
| | | | | | | | | | | | | | |
| | 2003 | | 2002 | |
| | (in millions) | |
Quadrant | | $ | — | | | $ | 59.5 | | |
Delsys | | | — | | | | 45.7 | | |
Naprelan | | | — | | | | 34.2 | | |
Marketing technology | | | — | | | | 20.8 | | |
Other | | | 32.6 | | | | 105.9 | | |
Total asset impairments | | $ | 32.6 | | | $ | 266.1 | | |
|
2003
The impairments of $32.6 million in 2003 related principally to our European sales and marketing business (sold to Zeneus in February 2004), a manufacturing and R&D business based in Switzerland (sold in February 2004), and to certain R&D technology platforms that we ceased using.
2002
We acquired Quadrant in December 2000 for $86.0 million. Quadrant was a drug delivery company with proprietary formulation technology applicable to pulmonary, oral and parenteral routes of administration. In 2002, we wrote-off the intangible assets arising from the acquisition of Quadrant of $59.5 million, as under the recovery plan we decided to dispose of or close the Quadrant business. We sold this business to a company managed by former employees of the business in July 2003 for one pound Sterling.
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In September 2001, we acquired Delsys, for $50.0 million. Delsys was formed in 1995 and was engaged in developing novel manufacturing technology. During 2002, we recorded an impairment charge for the intangible assets relating to Delsys of $45.7 million, as under our recovery plan, we decided to close Delsys.
The intangible asset associated with Naprelan was written-down by $34.2 million due to the impact of generic competition in 2002 and reduced projected revenue and profitability.
During 2002, we also recorded an impairment charge of $20.8 million related to the write-off of a marketing technology platform that we no longer used.
Other asset impairments in 2002 related to the write-off or impairment of a large number of less significant products, technologies and other assets.
(F) Gain on repurchase of LYONs
During 2003, we repurchased $1,323.4 million in principal amount at maturity of the LYONs. These LYONs, having an accreted value of $810.5 million at the date of purchase, were purchased at an aggregate cost of $803.4 million, resulting in a net gain of $1.6 million after related costs.
During 2002, we repurchased $318.6 million in principal amount at maturity of the LYONs. These LYONs, having an accreted value of $190.1 million at the date of purchase, were purchased at an aggregate cost of $149.8 million, resulting in a net gain of $37.7 million after related costs.
(G) Other litigation provisions
We recorded a provision during 2002 of $18.0 million relating to litigation with Schwarz Pharma, Inc., Allergan, Inc. and Allergan Sales, LLC and shareholder derivative actions.
(H) 401(K) rescission offer
In November 2002, we commenced a rescission offer with respect to 462,900 of our ADSs purchased by employees who participated in the Elan Pharmaceuticals 401(k) plan between 1998 and 2001. The sale of these ADSs to the participants in the 401(k) plan should have been registered under the Securities Act of 1933. The failure to register such sales necessitated the rescission offer. We recorded a charge of $13.5 million in 2002 as the result of the rescission offer.
21. Discontinued Operations, Sales of Businesses, and Held for Sale Assets and Liabilities
Discontinued Operations
A discontinued operation is a component of an entity whose operations and cash flows have been or will be eliminated from the ongoing operations of the entity, and with respect to which, the entity will not have any significant continuing involvement in the operations of the component after its disposal.
We have recorded the results and gains or losses on the divestment of our discontinued operations including Frova (frovatriptan succinate), Myobloc (botulinum toxin type B), the Pain Portfolio, Actiq (oral transmucosal fetanyl citrate), Abelcet (amphotericin B lipid complex) U.S./Canada, the dermatology portfolio of products, Athena Diagnostics, Elan Diagnostics, drug delivery businesses, Myambutol (ethambutol hydrochloride) and various other smaller operations within discontinued operations in the income statement, because we do not have a significant continuing involvement in the operations of these components.
For the years ended December 31, 2004, 2003 and 2002, the effect on the results of discontinued operations is set out below (in millions):
2004
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Revenue | | Cost of sales | | Selling, general and administrative expenses | | Research and development expenses | | (Gain)/loss on disposal of businesses | | Other charges | | Net interest and investment (gains)/ losses | | Provision for income taxes | | Income/ (loss) from discontinued operations |
(A) Frova | | $ | 15.0 | | | $ | 11.4 | | | $ | 2.7 | | | $ | — | | | $ | (7.9 | ) | | $ | — | | | $ | — | | | $ | — | | | $ | 8.8 | |
(B) Myobloc | | | 7.6 | | | | 1.4 | | | | 1.4 | | | | 3.4 | | | | (3.9 | ) | | | — | | | | — | | | | — | | | | 5.3 | |
Others | | | 6.1 | | | | 0.5 | | | | 0.4 | | | | (0.1 | ) | | | 0.3 | | | | — | | | | 0.1 | | | | — | | | | 4.9 | |
Total | | $ | 28.7 | | | $ | 13.3 | | | $ | 4.5 | | | $ | 3.3 | | | $ | (11.5 | ) | | $ | — | | | $ | 0.1 | | | $ | — | | | $ | 19.0 | |
|
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2003
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Revenue | | Cost of sales | | Selling, general and administrative expenses | | Research and development expenses | | (Gain)/loss on disposal of businesses | | Other charges | | Net interest and investment (gains)/ losses | | Provision for income taxes | | Income/ (loss) from discontinued operations |
(A) Frova | | $ | 38.5 | | | $ | 36.5 | | | $ | 9.7 | | | $ | — | | | $ | — | | | $ | — | | | $ | — | | | $ | — | | | $ | (7.7 | ) |
(B) Myobloc | | | 15.0 | | | | 6.3 | | | | 5.3 | | | | 11.6 | | | | — | | | | 43.6 | | | | — | | | | — | | | | (51.8 | ) |
(C) Pain Portfolio | | | 68.0 | | | | 17.0 | | | | 25.9 | | | | 0.3 | | | | (36.7 | ) | | | — | | | | 4.2 | | | | — | | | | 57.3 | |
(D) Actiq | | | 10.5 | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | 10.5 | |
Others | | | 43.2 | | | | 33.9 | | | | 9.6 | | | | 11.6 | | | | 13.8 | | | | 14.8 | | | | (1.5 | ) | | | 0.8 | | | | (39.8 | ) |
Total | | $ | 175.2 | | | $ | 93.7 | | | $ | 50.5 | | | $ | 23.5 | | | $ | (22.9 | ) | | $ | 58.4 | | | $ | 2.7 | | | $ | 0.8 | | | $ | (31.5 | ) |
|
2002
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Revenue | | Cost of sales | | Selling, general and administrative expenses | | Research and development expenses | | (Gain)/loss on disposal of businesses | | Other charges | | Net interest and investment (gains)/ losses | | Provision for income taxes | | Income/ (loss) from discontinued operations |
(A) Frova | | $ | 12.4 | | | $ | 18.2 | | | $ | 8.9 | | | $ | — | | | $ | — | | | $ | 24.4 | | | $ | — | | | $ | — | | | $ | (39.1 | ) |
(B) Myobloc | | | 19.7 | | | | 6.5 | | | | 18.6 | | | | 14.4 | | | | — | | | | 77.8 | | | | — | | | | — | | | | (97.6 | ) |
(C) Pain Portfolio | | | 59.8 | | | | 19.4 | | | | 18.0 | | | | 0.2 | | | | — | | | | 86.3 | | | | 4.6 | | | | — | | | | (68.7 | ) |
(D) Actiq | | | 31.8 | | | | 1.8 | | | | 5.0 | | | | — | | | | — | | | | — | | | | — | | | | — | | | | 25.0 | |
(E) Abelcet | | | 77.4 | | | | 27.1 | | | | 32.7 | | | | — | | | | (112.6 | ) | | | 1.8 | | | | — | | | | — | | | | 128.4 | |
(F) Dermatology | | | 47.5 | | | | 14.6 | | | | 48.7 | | | | 0.5 | | | | — | | | | 41.1 | | | | — | | | | — | | | | (57.4 | ) |
(G) Diagnostics | | | 70.6 | | | | 29.4 | | | | 22.6 | | | | 3.4 | | | | (65.3 | ) | | | 12.9 | | | | 0.4 | | | | 11.3 | | | | 55.9 | |
(H) Drug delivery | | | 14.5 | | | | 18.0 | | | | 4.0 | | | | 14.3 | | | | — | | | | (4.1 | ) | | | 0.9 | | | | — | | | | (18.6 | ) |
(I) Myambutol | | | 1.3 | | | | 0.7 | | | | 2.5 | | | | — | | | | — | | | | 78.0 | | | | — | | | | — | | | | (79.9 | ) |
Others | | | 27.0 | | | | 19.1 | | | | 7.6 | | | | 10.5 | | | | — | | | | 26.0 | | | | — | | | | 0.4 | | | | (36.6 | ) |
Total | | $ | 362.0 | | | $ | 154.8 | | | $ | 168.6 | | | $ | 43.3 | | | $ | (177.9 | ) | | $ | 344.2 | | | $ | 5.9 | | | $ | 11.7 | | | $ | (188.6 | ) |
|
(A) Frova
We licensed exclusive North American sales and distribution rights for Frova in October 1998 from Vernalis plc ("Vernalis"). Frova is a 5HT1B/1D agonist used as an anti-migraine therapy. In November 2001, the Food and Drug Administration ("FDA") approved Frova for the acute treatment of migraine. In 2002, the intangible assets related to Frova were written-down by $24.4 million to reflect reduced projected revenue and profitability from this product. In 2004, we terminated the development and license agreements with Vernalis regarding Frova and Vernalis purchased our commercialization rights in North America for Frova resulting in a net gain of $7.9 million.
(B) Myobloc
We developed Myobloc (Neurobloc in Europe). It is a sterile liquid formulation of a purified neurotoxin that acts at the neuromuscular junction to produce flaccid paralysis. Myobloc was approved by the FDA for the treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain. Myobloc was launched in the United States in December 2000 and Neurobloc was launched in the European Union in March 2001. The carrying value of Myobloc was written down by $77.8 million in 2002 due to lower than expected revenue from this product for 2002 and changed expectations for this product. A further impairment charge of $43.6 million was recorded in 2003. The product was sold to Solstice NeuroSciences LLC in July 2004 resulting in a gain of $3.9 million.
(C) Pain Portfolio
We acquired the Pain Portfolio from Roxane Laboratories ("Roxane") in September 2001. These products included the rights to Roxicodone (oxycodone hydrochloride) tablets and oral solution, Oramorph SR (morphine sulfate sustained-release) tablets, Roxanol (morphine sulfate) and Duraclon (clonidine hydrochloride). The intangible assets related to the Pain Portfolio were written down by $86.3 million during 2002 due to supply difficulties since its acquisition, leading to diminished selling support, as well as changed commercial expectations related to generic competition. The Pain Portfolio was sold to aaiPharma Inc. ("aaiPharma") in December 2003. The total consideration was $101.8 million, comprising a cash payment of $50.4 million and the assumption, by aaiPharma, of $51.4 million of our product payment obligations to Roxane resulting in a gain of $36.7 million.
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(D) Actiq
In October 2002, we sold our rights to Actiq in twelve territories, principally in Europe, to Anesta Corp. ("Anesta"), a subsidiary of Cephalon Inc. At the date of disposal, Actiq was marketed by Elan in the United Kingdom, Ireland and Germany. We received $47.8 million in cash from Anesta. Included within 2003 discontinued operations' product revenue for Actiq is $10.5 million (2002: $31.8 million) related to the sale of this product.
(E) Abelcet
We acquired Abelcet with The Liposome Company, Inc. ("Liposome") in May 2000. Abelcet, which is an amphotericin B lipid complex, is used for the treatment of systemic fungal infections. These infections mainly occur in immuno-compromised patients such as those undergoing cancer chemotherapy. In November 2002, we sold our U.S., Canadian and Japanese rights to Abelcet, and certain related assets, to Enzon Pharmaceuticals ("Enzon"). We received a net cash payment of $360.0 million from Enzon, representing the total consideration, after agreed price adjustments. The gain amounted to $112.6 million. In February 2004, we sold our remaining marketing rights to Abelcet to Zeneus Pharma Ltd. ("Zeneus") (formerly Medeus Pharma Ltd.) as part of the sale of our European sales and marketing business.
(F) Dermatology
In June 2002, we elected not to exercise our purchase option to acquire certain dermatology products from GlaxoSmithKline, plc ("GSK"). This resulted in rights to all products reverting to GSK at the end of 2002. As a result of this decision, we wrote-down the related assets by $41.1 million.
(G) Diagnostics
We recorded an impairment charge of $12.9 million in 2002 related to Elan Diagnostics, Inc. ("Elan Diagnostics") due to changed expectations for this business. In December 2002, we together with the other stockholders of our subsidiary, Athena Diagnostics, Inc. ("Athena Diagnostics"), completed the sale of all of the outstanding stock of Athena Diagnostics to Behrman Capital and certain of its affiliated investment funds for $81.8 million and a net gain of $65.3 million. In April 2003, we completed the sale of the assets of Elan Diagnostics to Novitron International, Inc. and recorded a gain of $0.3 million on disposal (included in "others" for 2003).
(H) Drug delivery
During the course of the recovery plan, we sold or closed a number of drug delivery businesses, including the sale of a transdermal technology business, and the closure of our medipad business and our research facility in Princeton. We recorded impairment charges $4.1 million and $11.3 million in 2002 and 2003, respectively, related to these businesses and gains on sales in 2003 of $5.3 million.
(I) Myambutol
The intangible assets related to Myambutol were written down by $78.0 million during 2002 due to the impact of generic competition on this product and reduced project revenue and profitability. Myambutol was sold to Stat-Trade, Inc. in April 2004, resulting in a loss of $0.6 million on the sale (included in "others" for 2004 and 2003).
Sale of Businesses — Continuing Operations
During the course of the recovery plan and subsequent realignment of our operation as a biotech company, we sold a number of businesses (principally Zonegran, the primary care franchise and the European sales and marketing business), which are not included in discontinued operations because we have a significant continuing involvement in the operations of these businesses, for example, through ongoing supply arrangements or formulation activities.
For the years ended December 31, 2004 and 2003, details of the disposal of businesses are given below (in millions):
| | | | | | | | | | |
| | Net Gain/(Loss) 2004 | | Net Gain/(Loss) 2003 |
Zonegran | | $ | 42.9 | | | $ | — | |
European business | | | (2.9 | ) | | | — | |
Primary care franchise (SkelaxinTM metaxalone and SonataTM zaleplon) | | | — | | | | 264.4 | |
Other | | | 4.2 | | | | 3.4 | |
Total gain on sale of businesses | | $ | 44.2 | | | $ | 267.8 | |
|
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2004
In March 2004, we announced an agreement with Eisai for the sale of our interests in Zonegran in North America and Europe. The sale of Zonegran to Eisai closed in April 2004 for a total consideration of $130.5 million before making a $17.0 million payment to Dainippon Pharmaceutical Co., Ltd. related to the assignment of the Zonegran license agreements. The gain amounted to $42.9 million. With respect to Zonegran, we may receive additional consideration of up to $110.0 million from Eisai through January 1, 2006. The deferred consideration will be recorded as a gain if and when it is earned and entitled to be received. These payments are contingent on Zonegran receiving marketing approval in Europe ($25.0 million) and no generic zonisamide being introduced in the U.S. market before January 1, 2006 ($85.0 million). The $85.0 million will be paid in installments on various dates up to January 1, 2006, assuming no generic zonisamide has been introduced in the U.S. market as of such dates. On March 16, 2005, Eisai announced the European Union granted marketing authorization approval for Zonegran and, as a result, we received $25.0 million from Eisai in March 2005. In addition, as no generic zonisamide had been launched in the U.S. market by March 31, 2005, we received $17.0 million of the $85.0 million from Eisai in April 2005.
In February 2004, we sold our European sales and marketing business to Zeneus for net cash proceeds of $93.2 million, resulting in a loss of $2.9 million. We received an additional $6.0 million in February 2005. Approximately 180 employees of our European sales and marketing business transferred to Zeneus.
2003
In 2003, a net gain of $264.4 million was recognized on the divestment of the primary care franchise to King Pharmaceuticals, Inc. ("King') (principally our rights to Sonata and Skelaxin). In June 2003, King paid gross consideration on closing of $749.8 million, which included the transfer to King of Sonata and Skelaxin inventory with a value of approximately $40.0 million and obligations related to Sonata of $218.8 million that were assumed by King at closing. In addition, in January 2004, we received an additional $25.0 million payment, which was contingent on the ongoing patent exclusivity of Skelaxin through December 31, 2003. The amount was included in the gain recorded in 2003 as the contingency was resolved by December 31, 2003. We will also continue to receive royalties on net sales of Skelaxin until 2021.
We did not dispose of any businesses in 2002.
Asset and Liabilities Held for Sale
In accordance with SFAS No. 144 and as a part of our recovery plan, at December 31, 2003, we recorded as held for sale the assets and liabilities related to our former European sales and marketing business, a San Diego office property and Elan Pharma S.A., a manufacturing and R&D business based in Switzerland. Each of these divestments were completed during the first quarter of 2004.
22. Share Capital
Share capital at December 31, 2004 and 2003 was:
| | | | | | |
Authorized Share Capital | | No. of Ordinary Shares |
Ordinary Shares (par value 5 Euro cent) | | | 600,000,000 | |
Executive Shares (par value 1.25 Euro)(the "Executive Shares") | | | 1,000 | |
"B" Executive Shares (par value 5 Euro cent)(the "B" Executive Shares") | | | 25,000 | |
|
| | | | | | | | | | | | | | | | | | |
| | At December 31, 2004 | | At December 31, 2003 |
Issued and Fully Paid Share Capital | | Number | | $000s | | Number | | $000s |
Ordinary Shares | | | 395,072,974 | | | | 22,574 | | | | 386,182,274 | | | | 22,015 | |
Executive Shares | | | 1,000 | | | | 2 | | | | 1,000 | | | | 2 | |
"B" Executive Shares | | | 21,375 | | | | 2 | | | | 21,375 | | | | 2 | |
|
In November 2003, we successfully completed a private offering of 35.0 million Ordinary Shares at a price of $4.95 per share.
The Executive Shares do not confer on the holders thereof the right to receive notice of, attend or vote at any of our meetings, or the right to be paid a dividend out of our profits, except for such dividends as the directors may from time to time determine.
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The "B" Executive Shares confer on the holders thereof the same voting rights as the holders of Ordinary Shares. The "B" Executive Shares do not confer on the holders thereof the right to be paid a dividend out of our profits except for such dividends as the directors may from time to time determine.
Shares issuable at December 31, 2004 of $0.7 million relate to shares of Athena Neurosciences, Inc., ("Athena Neurosciences"), Sano Corporation ("Sano"), Neurex Corporation ("Neurex"), Liposome and Dura Pharmaceuticals, Inc. ("Dura") common stock remaining to be converted into Ordinary Shares pursuant to the acquisition of these companies.
In October 1998, we completed the acquisition of all of the assets and liabilities of NanoSystems LLC ("Nanosystems"). As part of the acquisition, we issued warrants with an estimated value of $16.4 million, to acquire 1.5 million Ordinary Shares at an exercise price of $45 per share. The warrants are included in shares issuable at December 31, 2004 and are exercisable until October 2006.
At the Annual General Meeting in May 1999, we were authorized to make market purchases of up to 15% of the issued share capital on that date. During the remainder of the year ended December 31, 1999, we purchased 621,500 Ordinary Shares of Elan at a cost of $17.4 million and these are currently held in treasury stock. In 2000, we terminated our share purchase program.
23. Accumulated Other Comprehensive Income
The components of accumulated other comprehensive income, net of $Nil taxes, were as follows (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Net unrealized gains on available-for-sale securities | | $ | 20.9 | | | $ | 110.5 | |
Currency translation adjustments | | | (12.8 | ) | | | (12.0 | ) |
Accumulated other comprehensive income | | $ | 8.1 | | | $ | 98.5 | |
|
24. Pension and Other Employee Benefit Plans
Pension
The pension costs of the major Irish retirement plans have been presented in the following tables in accordance with the requirements of SFAS No. 132 Employees' Disclosures about Pensions and Other Postretirement Benefits." We fund the pensions of certain employees through defined benefit plans. Two plans are operated for employees based in Ireland. In general, on retirement, eligible employees are entitled to a pension calculated at 1/60th of their final salary for each year of service, subject to a maximum of 40 years. These plans are managed externally and the related pension costs and liabilities are assessed in accordance with the advice of a professionally qualified actuary. The investments of the plans at December 31, 2004 consisted of units held in independently administered funds. The change in benefit obligation was (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Benefit obligation at January 1 | | $ | 37.6 | | | $ | 27.4 | |
Service cost | | | 2.4 | | | | 2.1 | |
Interest cost | | | 1.9 | | | | 1.6 | |
Plan participants' contributions | | | 1.3 | | | | 1.4 | |
Actuarial gain/(loss) | | | 2.6 | | | | (0.6 | ) |
Benefits paid | | | (0.2 | ) | | | (0.3 | ) |
Foreign currency exchange rate changes | | | 3.7 | | | | 6.0 | |
Benefit obligation at December 31 | | $ | 49.3 | | | $ | 37.6 | |
|
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The changes in plan assets at December 31 were (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Fair value of plan assets at beginning of year | | $ | 34.5 | | | $ | 21.0 | |
Actual return on plan assets | | | 3.2 | | | | 3.3 | |
Employer contribution | | | 2.6 | | | | 3.9 | |
Plan participants' contributions | | | 1.3 | | | | 1.4 | |
Benefits paid | | | (0.2 | ) | | | (0.3 | ) |
Foreign currency exchange rate changes | | | 3.3 | | | | 5.2 | |
Fair value of plan assets at end of year | | $ | 44.7 | | | $ | 34.5 | |
| | | | | | | | |
Funded status | | $ | (4.7 | ) | | $ | (3.1 | ) |
Unrecognized net actuarial gain | | | 15.6 | | | | 13.1 | |
Unamortized prior service cost | | | 1.1 | | | | 1.1 | |
Prepaid benefit cost | | $ | 12.0 | | | $ | 11.1 | |
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The net periodic pension cost was comprised of the following (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Service cost | | $ | 2.4 | | | $ | 2.1 | | | $ | 1.8 | |
Interest cost | | | 1.9 | | | | 1.6 | | | | 1.2 | |
Expected return on plan assets | | | (2.4 | ) | | | (2.1 | ) | | | (1.9 | ) |
Amortization of net loss | | | 0.5 | | | | 0.6 | | | | 0.3 | |
Amortization of prior service cost | | | 0.1 | | | | 0.1 | | | | 0.1 | |
Net periodic pension cost | | $ | 2.5 | | | $ | 2.3 | | | $ | 1.5 | |
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Weighted average assumptions used to determine net periodic pension cost and benefit obligation at December 31 were:
| | | | | | | | | | |
| | 2004 | | 2003 |
Discount rate | | | 4.5 | % | | | 5.2 | % |
Expected return on plan assets | | | 6.4 | % | | | 6.9 | % |
Rate of compensation increase | | | 3.8 | % | | | 4.0 | % |
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The expected long-term rate of return on assets of 6.4% was calculated based on the assumptions of the following returns for each asset class: Equities 7.25%; Property 6.25%; Government Bonds 4.25%; and Cash 2.0%.
The fixed interest yield at December 31, 2004 was 4.25%; hence the assumed return on bonds is 4.25%. Returns for the other asset classes are set by reference to the fixed interest yield plus a risk premium. For equities the risk premium is 3% and for property the premium is 2%.
The weighted average asset allocations at December 31 by asset category were:
| | | | | | | | | | |
| | 2004 | | 2003 |
Equity | | | 73.5 | % | | | 74.5 | % |
Bonds | | | 14.6 | % | | | 16.8 | % |
Property | | | 5.5 | % | | | 6.9 | % |
Cash / other | | | 6.4 | % | | | 1.8 | % |
Total | | | 100.0 | % | | | 100.0 | % |
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Our pension plan assets are invested in two managed unit trusts. Our key objective is to achieve long-term capital growth by investing primarily in a range of Eurozone and international equities, bonds, property and cash.
The investment mix is biased towards equities, with a diversified domestic and international portfolio of shares listed and traded on recognized Exchanges.
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The long-term asset allocation ranges of the trusts are as follows:
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| | | | | | |
Equities | | 60% – 80% |
Bonds | | 10% – 40% |
Property | | 0% – 10% |
Cash | | 0% – 10% |
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The accumulated benefit obligation for all defined benefit pension plans was $42.0 million at December 31, 2004 (2003: $31.3 million).
At December 31, 2004, the expected future cash benefits per year to be paid in respect of the plans for the period of 2005-2009 are collectively less than $1.0 million. The expected cash benefits to be paid in the period of 2010-2014 is approximately $1.1 million.
The expected benefits to be paid are based on the same assumptions used to measure our benefit obligation at December 31, 2004 and include the estimated future employee service.
We contributed $2.6 million to our pension plan in 2004. We recognized a $9.8 million charge to Other Comprehensive Income in 2002 in respect of the shortfall between the unfunded accumulated benefit obligation less the unrecognized prior service cost and the prepaid benefit cost. This was reversed in 2003 as the shortfall no longer existed at December 31, 2003. There was no shortfall in the plans at December 31, 2004. We expect to contribute $2.1 million to our pension plan in 2005.
In addition, we operate a number of defined contribution pension plans, primarily for employees outside of Ireland. The costs of these plans are charged to the income statement in the period they are incurred. The pension cost for these plans was $10.3 million, $9.2 million and $8.8 million for 2004, 2003 and 2002, respectively.
Stock Options and Warrants
Stock options have been granted to directors, employees, consultants and certain other parties. Options are granted at the price equal to the market value at the date of grant and will expire on a date not later than ten years after their grant. Options generally vest between one and five years from the date of grant.
The following table summarizes the number of options outstanding and available to grant as of December 31:
| | | | | | | | | | | | | | | | | | |
| | Outstanding | | Available to Grant |
| | 2004 | | 2003 | | 2004 | | 2003 |
1986/1989 Plans | | | — | | | | 44,400 | | | | — | | | | — | |
1996 Plan | | | 8,784,892 | | | | 9,290,558 | | | | 3,256,142 | | | | 4,342,004 | |
1998 Plan | | | 4,246,395 | | | | 4,841,957 | | | | — | | | | — | |
1999 Plan | | | 27,012,432 | | | | 33,758,641 | | | | 2,671,459 | | | | 2,802,142 | |
Segix Plan | | | 319,670 | | | | 376,501 | | | | — | | | | — | |
Consultant Plan | | | 425,000 | | | | 425,000 | | | | — | | | | — | |
Total | | | 40,788,389 | | | | 48,737,057 | | | | 5,927,601 | | | | 7,144,146 | |
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We also have granted options and warrants for acquisitions, a developing and license agreement and a service agreement. As a result of the acquisition of Athena Neurosciences on July 1, 1996, options and warrants granted by Athena Neurosciences prior to the acquisition date vested and were converted into options and warrants to acquire 6,346,424 Ordinary Shares. As a result of the acquisition of Neurex on August 14, 1998, options and warrants granted by Neurex were converted into a total of 3,011,702 options to acquire Ordinary Shares. As a result of the acquisition of Liposome on May 12, 2000, options and warrants granted by Liposome were converted into a total of 1,875,260 options to acquire Ordinary Shares. As a result of the acquisition of Dura on November 9, 2000, options and warrants granted by Dura vested and were converted into options and warrants to acquire 5,513,457 Ordinary Shares. The following table summarizes the number of acquisition related options outstanding as of December 31:
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| | | | | | | | | | |
| | 2004 | | 2003 |
Athena Neurosciences | | | 120,996 | | | | 206,276 | |
Neurex | | | 66,370 | | | | 99,872 | |
Liposome | | | 125,147 | | | | 149,971 | |
Dura | | | 63,171 | | | | 107,213 | |
Total | | | 375,684 | | | | 563,332 | |
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Arising from the acquisition by us of all the assets and liabilities of NanoSystems, we granted 750,000 warrants to purchase 1,500,000 Ordinary Shares. These warrants are exercisable at $45.00 per share from February 1, 1999 to October 1, 2006 and were unexercised as of December 31, 2004 and 2003.
The stock options and warrants outstanding and exercisable are summarized as follows:
| | | | | | | | | | | | | | | | | | |
| | Options | | Warrants |
| | Shares | | WAEP* | | Shares | | WAEP* |
Outstanding at December 31, 2001 | | | 40,913,911 | | | $ | 34.06 | | | | 6,121,622 | | | $ | 39.89 | |
Exercised | | | (544,124 | ) | | | 17.59 | | | | (7,432 | ) | | | 28.01 | |
Granted | | | 21,905,272 | | | | 5.46 | | | | — | | | | — | |
Expired | | | (9,253,816 | ) | | | 34.89 | | | | (1,045,246 | ) | | | 46.05 | |
Outstanding at December 31, 2002 | | | 53,021,243 | | | | 22.28 | | | | 5,068,944 | | | | 38.64 | |
Exercised | | | (764,944 | ) | | | 2.39 | | | | — | | | | — | |
Granted | | | 5,956,098 | | | | 4.47 | | | | — | | | | — | |
Expired | | | (8,912,008 | ) | | | 24.54 | | | | (2,494,498 | ) | | | 32.51 | |
Outstanding at December 31, 2003 | | | 49,300,389 | | | | 20.03 | | | | 2,574,446 | | | | 39.20 | |
Exercised | | | (8,879,018 | ) | | | 7.83 | | | | (12 | ) | | | 26.72 | |
Granted | | | 5,767,595 | | | | 19.70 | | | | — | | | | — | |
Expired | | | (5,024,893 | ) | | | 31.34 | | | | — | | | | — | |
Outstanding at December 31, 2004 | | | 41,164,073 | | | | 21.24 | | | | 2,574,434 | | | | 39.20 | |
Exercisable at December 31, 2004 | | | 31,335,573 | | | $ | 23.44 | | | | 2,574,434 | | | $ | 39.20 | |
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| |
* | Weighted average exercise price |
At December 31, 2004, the range of exercise prices and weighted average remaining contractual life of outstanding and exercisable options were as follows:
| | | | | | | | | | | | | | | | | | | | | | |
Number Outstanding | | WAEP | | Range | | Weighted Average Remaining Contractual Life (years) | | Number Exercisable | | WAEP |
13,588,154 | | $ | 2.96 | | | $ | 1.93–$10.00 | | | | 7.9 | | | | 9,519,637 | | | $ | 2.69 | |
10,747,844 | | $ | 17.06 | | | $ | 10.01–$25.00 | | | | 6.6 | | | | 6,596,362 | | | $ | 16.59 | |
11,016,661 | | $ | 31.53 | | | $ | 25.01–$40.00 | | | | 4.8 | | | | 9,764,661 | | | $ | 32.25 | |
5,811,414 | | $ | 52.20 | | | $ | 40.01–$58.60 | | | | 6.2 | | | | 5,454,913 | | | $ | 52.18 | |
41,164,073 | | $ | 21.24 | | | $ | 1.93–$58.60 | | | | 6.5 | | | | 31,335,573 | | | $ | 23.44 | |
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Employee Equity Purchase Plans
In June 2004, our shareholders approved a qualified Employee Equity Purchase Plan ("U.S. Purchase Plan"), under Sections 421 and 423 of the Internal Revenue Code ("IRC"), which became effective on January 1, 2005 for eligible employees based in the U.S. The plan allows eligible employees to purchase common stock at 85% of the lower of the fair market value at the start of the offering period or the fair market value on the last trading day of the offering period. Purchases are limited to $25,000 per calendar year, 1,000 shares per offering period, and subject to certain IRC restrictions.
The board of directors approved the Irish Sharesave Option Scheme 2004 and U.K. Sharesave Option Plan 2004, effective January 1, 2005, for employees based in Ireland and the United Kingdom, respectively ("the Irish/U.K.
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Sharesave Plans"). In total, 1,500,000 shares have been reserved for issuance under the Irish/U.K. Sharesave Plans and U.S. Purchase Plan combined. The Irish/U.K. Sharesave Plans allow eligible employees to purchase at no lower than 85% of the fair market value at the start of the thirty-six month offering period. The plan allows eligible employees to save up to 320 Euro per month under the Irish Scheme or 250 pounds Sterling under the U.K. Plan and they may purchase shares anytime within six months after the end of the offering period.
As of December 31, 2004, 1,500,000 shares were reserved for future issuance under the U.S. Purchase Plan and Irish/U.K. Sharesave Plans.
Employee Savings and Retirement Plan 401(K)
We maintain a 401(k) retirement savings plan for our employees based in the United States. Participants in the 401(k) plan may contribute up to 20% of their annual compensation, limited by the maximum amount allowed by the Internal Revenue Code. We match 3% of each participating employee's annual compensation on a quarterly basis and may contribute discretionary matching up to another 3% of the employee's annual compensation on an annual basis. Our matching contributions are vested immediately. For the year ended December 31, 2004, we recorded $5.1 million (2003: $7.5 million; 2002: $6.2 million), of expense in connection with the matching contributions under the 401(k) plan.
25. Commitments and Contingencies
As of December 31, 2004, the directors had authorized the following capital commitments for the purchase of property, plant and equipment (in millions):
| | | | | | |
Contracted for | | $ | 15.9 | |
Not-contracted for | | | 24.1 | |
Total | | $ | 40.0 | |
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In prior years, we disposed of plant and equipment and subsequently leased them back and also entered into an arrangement with a third party bank, the substance of which allows us to require a net settlement of our obligations under the leases. The related assets and liabilities of these previous sale and leaseback transactions have been offset in the Consolidated Financial Statements in the amount of $64.4 million at December 31, 2004 (2003: $63.8 million).
At December 31, 2004, we had commitments to invest $3.2 million (2003: $3.8 million) in healthcare managed funds.
In disposing of assets or businesses, we often provide customary representations, warranties and indemnities (if any) to cover various risks. We do not have the ability to estimate the potential liability from such indemnities because they relate to unknown conditions. However, we have no reason to believe that these uncertainties would have a material adverse effect on our financial condition or results of operations.
26. Litigation
We are involved in various legal and administrative proceedings, relating to securities matters, patent matters, antitrust matters and other matters. The most significant of these matters are described below.
As of December 31, 2004, we had accrued $63.4 million for the resolution of legal matters, including $55.0 million relating to the securities matters and SEC investigation described below. We developed these estimates in consultation with outside counsel handling our defense in these matters using the current facts and circumstances known to us. The factors that we consider in developing our legal contingency accrual include the merits and jurisdiction of the litigation, the nature and number of other similar current and past litigation cases, the nature of the product and current assessment of the science subject to the litigation, and the likelihood of settlement and current state of settlement discussions, if any. With the exception of such securities matters/SEC investigation and the BioPort Corporation ("BioPort") litigation, we do not believe that it is feasible to predict or determine the outcomes of the pending actions, investigations and proceedings and any possible effect on our business or to reasonably estimate the amounts of minimum losses or potential range of losses, if any, with respect to the pending actions, investigations and proceedings.
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The costs and other effects of pending or future litigation, governmental investigations, legal and administrative cases and proceedings, settlements, judgments and claims, and changes in those matters (including the matters described below) and developments or assertions by or against us relating to intellectual property, could have a material adverse effect on our business, financial condition, results of operations and liquidity.
Securities matters
Commencing in January 1999, several class actions were filed in the U.S. District Court for the Southern District of California against Dura, one of our subsidiaries, and various then current or former officers of Dura. The actions, which allege violations of the U.S. federal securities laws, were consolidated and sought damages on behalf of a class of shareholders who purchased Dura common stock during a defined period. In July 2000, the court issued an order granting the defendants' motion to dismiss the complaint without prejudice on the basis that it failed to state an actionable claim. In November 2001, the court granted Dura's motion to dismiss with prejudice and judgment was entered in Dura's favor. In December 2001, plaintiffs filed an appeal of the judgment with the Ninth Circuit Court of Appeals. Oral argument was held on February 4, 2003. On August 5, 2003, the Ninth Circuit issued its opinion, reversing the lower court's prior dismissal. A timely petition for rehearing en banc was filed, but was denied by the Ninth Circuit on September 29, 2003. Thereafter, we petitioned the U.S. Supreme Court for a writ of certiorari. On June 28, 2004, the U.S. Supreme Court granted certiorari. The matter was argued before the U.S. Supreme Court on January 12, 2005 and the parties are currently awaiting a final decision.
We and certain of our former and current officers and directors were named as defendants in a class action filed in early 2002 in the U.S. District Court for the Southern District of New York alleging claims under the U.S. federal securities laws. The complaint alleged, among other things, that our Consolidated Financial Statements were not prepared in accordance with generally accepted accounting principles, and that the defendants disseminated materially false and misleading information concerning our business and financial results, with respect to our investments in certain business ventures and business venture parents and the license fees and research revenues received from the business ventures; the accounting for proceeds from our sale of certain product lines and disclosure concerning those sales; the accounting for certain risk-sharing arrangements that we entered into and disclosure concerning those arrangements; the accounting for certain qualified special purpose entities and disclosure concerning those entities; the disclosure of compensation of certain officers; and certain alleged related-party transactions. We settled this action in October 2004. Under the proposed class action settlement, all claims against us and the other named defendants would be dismissed with no admission or finding of wrongdoing on the part of any defendant. The principal terms of the proposed settlement provide for an aggregate cash payment to class members of $75.0 million, out of which the court would award attorneys' fees to plaintiffs' counsel, and $35.0 million which will be paid by our insurance carrier. On February 18, 2005, the court conducted a hearing on approval of the proposed settlement and took the matter under advisement. The parties are currently awaiting a final decision from the court.
We were also the subject of an investigation by the SEC's Division of Enforcement. We provisionally settled the investigation in October 2004. Under the settlement agreement, which received final approval in February 2005, we neither admitted nor denied the allegations contained in the SEC's civil complaint, which included allegations of violations of certain provisions of the federal securities laws. The settlement contains a final judgment restraining and enjoining us from future violations of these provisions. In addition, under the final judgment, we paid a civil penalty of $15.0 million. In connection with the settlement, we were not required to restate or adjust any of our historical financial results or information.
During 2004, we reserved $55.0 million, net of insurance coverage, with respect to our estimate of the ultimate cost to settle the shareholder class action and the SEC investigation.
We and some of our officers and directors have been named as defendants in putative class actions filed in the U.S. District Courts for the District of Massachusetts (on March 4 and 14, 2005), the Southern District of New York (on March 14, 2005) and the Superior Court of the State of California, County of San Diego (on March 23, 2005). The class action complaints allege claims under the U.S. federal securities laws and state laws and, in the actions filed in Massachusetts and New York, seek damages on behalf of a class of shareholders who purchased our stock prior to the announcement of the voluntary suspension of Tysabri. The action filed in California as a derivative action, purports to seek damages on our behalf. The complaints allege that we caused the release of materially false or misleading information regarding Tysabri. The complaints allege that class members were damaged when our stock price fell after we and Biogen Idec announced the voluntary suspension of the marketing and dosing of Tysabri in response to reports
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of serious adverse events involving clinical trial patients treated with Tysabri. The complaints seek damages and other relief that the courts may deem just and proper. We believe that the claims in the lawsuits are without merit and intend to defend against them vigorously.
In March 2005, we received a letter from the SEC stating that the SEC's Division of Enforcement is conducting an informal inquiry into actions and securities trading relating to us. The SEC's inquiry primarily relates to events surrounding the February 28, 2005 announcement of the decision to voluntarily suspend the marketing and clinical dosing of Tysabri.
Patent matters
In October 1998, we filed a patent infringement action in the U.S. District Court for the Southern District of Florida against Andrx Corporation ("Andrx") alleging that, by its submission of an Abbreviated New Drug Application ("ANDA") for a generic version of NaprelanTM (naproxen sodium controlled-release), which submission included a paragraph IV certification, Andrx infringed our U.S. Patent No. 5,637,320 (the "320 patent"). In March 2002, the court issued a decision finding the 320 patent invalid and dismissed the action. The court did not consider the issue of infringement. We subsequently appealed the decision to the U.S. Court of Appeals for the Federal Circuit ("CAFC"). On May 5, 2004, the CAFC reversed the district court's invalidation of our patent for its Naprelan product. The case has now been remanded to the district court for consideration of the remaining issues. On July 12, 2004, the U.S. District Court in Florida held a status conference in the case, during which the court indicated that it was prepared to issue a final decision in the case. The court asked the parties to file briefs updating the law on all outstanding issues. The additional briefing materials requested by the court have been filed and the parties are awaiting the court's final ruling; no additional hearings are expected at this time. It is currently unclear when the district court's ruling will be issued and we cannot predict with any certainty the likelihood of the ultimate outcome.
Eon Labs, Inc. ("EON") submitted to the FDA an ANDA for a generic equivalent of our 400 mg Skelaxin product. The application included a paragraph IV certification pertaining to U.S. patent No. 6,407,128 (the "128 patent"). Eon provided notice to Elan Pharmaceuticals, Inc. ("EPI") of its paragraph IV certification in November 2002, and we filed a patent infringement suit against Eon in the U.S. District Court for the Eastern District of New York on January 2, 2003. Eon filed its answer and counterclaim on January 23, 2003 and then filed an amended answer and counterclaim on February 19, 2003. We filed our reply to the counterclaim on March 7, 2003. Corepharma LLC ("Corepharma") also has submitted to the FDA an ANDA for a generic equivalent of our 400 mg Skelaxin product, including a paragraph IV certification pertaining to the 128 patent. Corepharma provided notice of its paragraph IV certification in January 2003, and we filed a patent infringement suit against Corepharma in the U.S. District Court for the District of New Jersey on March 7, 2003. In May 2003, we agreed to transfer the Corepharma litigation to the U.S. District Court for the Eastern District of New York for consolidation with the Eon litigation. The rights under the patents at issue in the Eon and Corepharma litigations were subsequently sold and transferred to King. Accordingly, we are cooperating in the prosecution of these matters and are working together to substitute King as a plaintiff to the two actions. Discovery in this matter is still ongoing and no trial date has been set. However, the parties will participate in an April 2005 court-ordered mediation aimed at resolving issues relating to both matters.
On December 17, 2004, King commenced a lawsuit in the U.S. District Court for the Eastern District of New York against Eon alleging patent infringement of the above-referenced 128 patent in connection with Eon's November 2004 amended ANDA submission to the FDA seeking the approval to engage in the manufacture, use or sale of an 800 mg generic equivalent of the Skelaxin product. On January 10, 2005, Eon answered King's complaint and counterclaimed against Elan Pharmaceuticals, Inc. Eon's counterclaims are similar to those asserted in the litigation described in the immediately preceding paragraph. Discovery relating to this matter has not yet commenced. Given the status of the proceedings and the fact that no discovery has taken place, we are unable to predict the likelihood of a successful outcome or any associated damages at this time. However, we believe that Eon's claims are without merit and intend to vigorously defend against the claims.
On November 3, 2004, Classen Immunotherapies, Inc. ("Classen") commenced a lawsuit against King, Elan Corporation, plc and EPI in the U.S. District Court for the District of Maryland alleging patent infringement of U.S. Patent No. 6,219, 674 (the "674 patent") and U.S. Patent No. 6,584,472 (the "472 patent"). Classen asserts, inter alia, that King and the Elan defendants purportedly infringed claims of the 674 and 472 patents in connection with their manufacture, development and distribution of our former Skelaxin product. We have answered Classen's complaint. King has filed a motion to dismiss Classen's claims as well as a motion to transfer the matter to the district court in Tennessee. To date,
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no hearing has been set for King's motions and no discovery has taken place. Given the status of the proceedings and the fact that no discovery has taken place, we are unable to predict the likelihood of a successful outcome or any associated damages at this time. However, we believe that the Classen claims are without merit and intend to vigorously defend against the claims.
On June 17, 2004, Duke University ("Duke") and Orexigen Therapeutics, Inc. ("Orexigen") filed a lawsuit against Elan Corporation, plc, Elan Pharmaceuticals, Inc., Eisai Co., Ltd., Eisai, Inc. and Elan employee, Julianne E. Jennings (collectively, "the Elan and Eisai Defendants") involving a provisional patent application (the "Patent Application") filed with the U.S. Patent and Trademark Office that relates to the use of our former zonisamide product and the treatment of obesity. On April 27, 2004, we transferred all of our rights in the zonisamide product and the Patent Application to Eisai, Inc. pursuant to an asset purchase agreement. Duke and Orexigen assert, inter alia, that the Patent Application fails to identify certain Duke employees as inventors or acknowledge Duke's purported rights in the application. We filed a motion to dismiss the claims on August 13, 2004. To date, no hearing has been scheduled on the motion. Given the status of the proceedings and the fact that no discovery has taken place, we are unable to predict the likelihood of a successful outcome or any associated damages at this time. We believe that the Duke and Orexigen claims are without merit and intend to vigorously defend against the claims.
Antitrust matters
In March 2001, Andrx filed a complaint in the U.S. District Court for the Southern District of Florida alleging that we engaged in anti-competitive activities in an effort to prevent or delay the entry of a generic alternative to Naprelan. We filed a motion to dismiss the complaint and for judgment on the pleadings. In April 2003, the court granted our motion and dismissed Andrx's complaint with prejudice and without leave to amend. In June 2003, the court reaffirmed its April decision, denying Andrx's motion for reconsideration and for leave to amend its complaint. On July 14, 2003, Andrx filed a notice of appeal. A hearing on the appeal took place on June 29, 2004. The parties are currently awaiting a final decision from the appellate court.
Indirect purchasers of Naprelan have filed three putative class actions in the U.S. District Court for the Eastern District of Pennsylvania against us and Skye Pharma, Inc. In September 2002, the cases were consolidated and in October 2002, a consolidated amended class action complaint was filed. The consolidated complaint alleges that we violated the antitrust laws by engaging in sham patent litigation and entering into an unlawful settlement agreement in an effort to prevent or delay the entry of a generic alternative to Naprelan. The damages claimed are unspecified. We have not yet answered or otherwise responded to the amended complaint. Other than preliminary document production, the litigation has been stayed and the case placed on the court's suspense docket pending the outcome of further proceedings in the pending Andrx patent infringement litigation described above. On August 4, 2003 plaintiffs filed a motion to remove the litigation from the court's suspension docket. However, the court subsequently denied plaintiffs' motion and this matter remains on the court's suspension docket.
In June 2002, we entered into a settlement with the U.S. Federal Trade Commission ("FTC") resolving the FTC's investigation of a licensing arrangement between us and Biovail Corporation ("Biovail") relating to nifedipine, the generic version of the hypertension drug Adalat CC. The settlement is reflected in a consent order, which, by its terms, does not constitute an admission that any law has been violated, and does not provide for monetary fines or penalties. We continue to satisfy all of the terms of the consent order.
In 2002 and 2003, ten actions were filed in the U.S. District Courts (seven in the District of Columbia and three in the Southern District of New York) claiming that we (and others) have violated federal and state antitrust laws based on the licensing arrangement with Biovail relating to nifedipine. The complaints seek various forms of remedy, including damages and injunctive relief. The actions have been brought by putative classes of direct purchasers, individual direct purchasers, and putative classes of indirect purchasers. On May 29, 2003, the Judicial Panel for Multidistrict Litigation coordinated and consolidated for pre-trial proceedings all pending cases in the U.S. District Court for the District of Columbia. Since consolidation of the matters, the Court has held several case management conferences to coordinate the early stages of the case. In accordance with one of the Court's preliminary orders, Plaintiffs filed amended complaints. We and co-defendant Biovail responded by filing an omnibus motion to dismiss in response to the amended complaints. Co-defendant Teva filed a joinder in certain parts of our motion. The Court completed a hearing on the motions May 7, 2004 and took the matter under submission. On September 1, 2004, the Court issued a Memorandum Opinion and Order granting in part and denying in part the motions to dismiss. The Court held that none of the claims for injunctive relief had any basis and, accordingly, the Court lacked jurisdiction over the indirect purchaser federal and state claims.
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Consequently, the Court granted the motion as it related to the putative class of indirect purchasers and dismissed that consolidated class complaint without prejudice. The Court also dismissed the claims for injunctive relief of the purported direct purchaser plaintiffs. The Court declined to dismiss the damage claims of the purported direct purchaser plaintiffs, ruling that it would be premature to do so without allowing discovery given the Court's obligation to accept as true all allegations when tested on a motion to dismiss. The parties in the litigation have begun preliminary discovery. It should be noted that counsel for the putative indirect purchaser class have also commenced an action asserting the same or similar claims under California state law in California state court. Per the California state court's request, the parties have developed a plan to coordinate discovery with the remaining federal cases. We believe that our conduct is lawful, but as these matters are in their early stages, we cannot predict the likelihood of any outcome.
In June 2001, we received a letter from the FTC stating that the FTC was conducting a non-public investigation to determine "whether Brightstone Pharma, Inc., Elan Corporation or others may have engaged in an effort to restrain trade by entering into an agreement that may restrict the ability of Brightstone or others to market a bioequivalent or generic version of Naprelan". In October 2001, our counsel met informally with FTC Staff to discuss the matter. No further communication from the FTC was received until December 2002, when we were served with a subpoena duces tecum from the FTC for the production of documents related to Naprelan. We have voluntarily provided documents and witness testimony in response to the subpoena and continue to cooperate with the FTC relating to this investigation.
Other matters
On June 27, 2002, BioPort filed suit against us in the Superior Court of the State of California alleging breach of certain collaboration and supply agreements relating to the development, manufacture and supply of botulinum toxin. In addition to claims for breach of contract, BioPort asserted claims for intentional interference with contractual relations (as to the Company), unfair business practices and unjust enrichment. The complaint seeks a five percent royalty on net sales of Myobloc, payments allegedly owned under the collaboration agreement, a declaration that BioPort has an ownership interest in Myobloc, and other relief, including punitive damages. A trial date for this matter has been scheduled for July 15, 2005. In addition, the parties intend to conduct an April 2005 mediation conference aimed at resolving some or all of the issues before trial. Discovery in this matter is continuing.
On December 11, 2003, two of our subsidiaries, EPI and Neuralab, commenced AAA arbitration proceedings against Pfizer and Pharmacia and Upjohn Company ("Pharmacia") in connection with certain alleged breaches relating to an Exclusive Mutual Beta Secretase Inhibitors Research, Development and Marketing Collaboration Agreement, dated July 28, 2000, originally between Pharmacia and Neuralab. As a result of these breaches and our subsequent termination of the collaboration agreement, we believe that we hold an exclusive worldwide license of, among other things, all of Pfizer and Pharmacia's interest in regulatory approvals, patents and know-how relating to the subject matter of the parties' collaboration. On December 23. 2003, Pfizer and Pharmacia asked the New York State Supreme Court to stay our arbitration proceedings and the court subsequently issued a stay order on January 14, 2004. We appealed the stay order to the New York Supreme Court Appellate Division. On August 26, 2004, the New York Court Appellate Division reversed the lower court's decision and remanded the matter back to the lower court for further proceedings relating to whether our arbitration proceedings should be stayed.
On September 13, 2004, we commenced an action against Pfizer and Pharmacia in the California Superior Court. The complaint in this action asserts essentially the same breach of contract claim asserted in the AAA arbitration demand and also alleges claims for common-law monopolization, unfair competition and improper disclosure of trade secrets. In conjunction with the filing of their California lawsuit, we withdrew our arbitration demand. On September 23, 2004, Pfizer and Pharmacia commenced a New York state action against us for injunctive relief, declaratory relief and breach of contract. Immediately upon filing this action, Pfizer and Pharmacia asked the New York Supreme Court to stay our prosecution of the above-referenced California lawsuit. The New York state court subsequently issued an order temporarily staying us from taking any action in the above-referenced California lawsuit. In addition, the Court scheduled a February 14, 2005 evidentiary hearing on the applicability of certain dispute resolution provisions contained in the parties' collaboration agreement. The court has advised the parties that, after it conducts this evidentiary hearing, the court intends to lift its temporary stay order and permit us to proceed with our California litigation. The parties are currently engaged in discovery relating to the above-referenced evidentiary hearing. However, the hearing was temporarily taken off calendar to allow the parties to conduct settlement discussions.
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27. Related Parties
Antigenics
At December 31, 2003, we had invested a total of $14.9 million in Antigenics, a biotechnology company whose chairman, Dr. Garo Armen, is also a director of Elan. At December 31, 2003, our shareholding represented approximately 3% of Antigenics' outstanding share capital. At December 31, 2003, this investment had a carrying value of $11.0 million and a fair value of $12.5 million. In February and March 2004, we disposed of all of our 1,098,937 common shares in Antigenics for $11.4 million.
Following the appointment of Dr. Armen as chairman on July 9, 2002, we signed a memorandum of understanding with Antigenics in respect of costs incurred by either company in respect of work done for the other. The agreement provided that no profit margin should be charged on such costs. In 2004, the amount of such charges from Antigenics was approximately $0.1 million (2003: $0.2 million) and the amount of such charges to Antigenics was $Nil (2003: $0.2 million).
In addition, on February 28, 2003, a settlement was signed between Antigenics, Neuralab and EPI regarding a dispute relating to a supply agreement entered into on November 23, 1999 between Antigenics, then known as Aquila Biopharmaceuticals, Inc., Neuralab and EPI. Under the terms of the settlement, Elan paid Antigenics $0.3 million and received an agreed amount of an adjuvant.
Amarin/Mr. Thomas Lynch
Amarin Corporation plc ("Amarin") is a specialty pharmaceutical company focused on neurodegenerative and pain management. Thomas Lynch, a former employee and executive vice chairman, and John Groom, a director of Elan, serve on Amarin's board of directors. Mr. Lynch is non-executive chairman of Amarin.
2001 to 2003
In 2001, we entered into a distribution and option agreement with Amarin, whereby Amarin agreed to market and distribute PermaxTM (pergolide mesylate) in the United States, and Amarin was granted an option to acquire rights to the product from us. We subsequently provided a loan of $45.0 million to Amarin in 2001, the proceeds of which were used by Amarin to exercise its option to acquire Permax from us. Permax is used for the treatment of Parkinson's disease. The terms of the distribution and option agreement and the loan agreement were subsequently amended in 2001 and 2003.
During 2001, we also granted Amarin a purchase option to acquire ZelaparTM (selegiline). Zelapar is a fast melt formulation of selegiline for the treatment of Parkinson's disease.
2004
In February 2004, we further amended our contractual arrangements subject to the sale by Amarin of certain of its assets, including its rights to Zelapar and Permax, to Valeant Pharmaceuticals International ("Valeant"). On February 25, 2004, Amarin's sale of assets to Valeant closed and the amendments became effective. The amendments required, in full settlement of all previous liabilities owed by Amarin to us and as a deemed exercise of Amarin's option to acquire Zelapar, the payment by Amarin of $17.2 million to us, which was paid in February 2004, and the issuance of a $5.0 million five-year 8% loan note and issued warrants to purchase 500,000 ordinary shares in Amarin to Elan. Under the agreements, we were also entitled to receive a $1.0 million milestone payment upon the successful completion of certain Zelapar safety studies. The milestone was received in December 2004. We are also entitled to receive from Valeant a revenue contingent milestone on Zelapar of $10.0 million if annual sales of Zelapar exceed $20.0 million, and royalties on future net sales by Valeant of 13% for Zelapar and 10% for Permax.
In February 2004, our share ownership in Amarin increased to approximately 28% on a fully diluted basis. Prior to September 30, 2004, we accounted for Amarin using the equity method based on our equity investment in Amarin. Amarin was a related party to us until this date.
On September 30, 2004, we sold all of our remaining investments in Amarin for $6.5 million to Amarin Investment Holding Ltd., a company controlled by Mr. Thomas Lynch.
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The following table summarizes our investment in Amarin at December 31 (in millions):
| | | | | | | | | | |
| | 2004 | | 2003 |
Loans and related interest | | $ | — | | | $ | 18.1 | |
Net equity investment | | | — | | | | 3.0 | |
Total investment | | $ | — | | | $ | 21.1 | |
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Net revenue earned from Amarin was $3.0 million for 2004 (2003: $0.3 million; 2002: $4.8 million).
28. Development and Marketing Collaboration Agreement with Biogen Idec
In August 2000, we entered into a development and marketing collaboration agreement with Biogen Idec, successor to Biogen, Inc., to collaborate in the development and commercialization of Tysabri. Along with Biogen Idec, we are developing Tysabri for multiple sclerosis ("MS"), Crohn's disease and RA, with Biogen Idec acting as the lead party for MS and Elan acting as the lead party for Crohn's disease and RA.
In November 2004, Tysabri received regulatory approval in the U.S. for the treatment of relapsing forms of MS. Biogen Idec paid us a $7.0 million approval-based milestone. The approval milestone payment, together with other milestone payments related to the collaboration agreement of $45.0 million, are recognized as revenue based on the percentage-of-completion method, which is based on the percentage of costs incurred to date compared to the total costs expected under the contract.
Biogen Idec manufactures Tysabri. We purchase Tysabri from Biogen Idec for distribution to third parties in the U.S. We recorded $6.4 million in product revenue from Tysabri in 2004. In general, we share with Biogen Idec most development and commercialization costs. At December 31, 2004, we owed Biogen Idec $34.4 million for the reimbursement of costs related to development and commercialization.
On February 28, 2005, we and Biogen Idec announced the voluntary suspension of the marketing and dosing in clinical trials of Tysabri. This decision was based on reports of two serious adverse events in patients treated with Tysabri in combination with Avonex in clinical trials. These events involved two cases of progressive multifocal leukoencephalopathy ("PML"), a rare and frequently fatal demyelinating disease of the central nervous system. Both patients received more than two years of Tysabri therapy in combination with Avonex. On March 30, 2005, we and Biogen Idec announced that our ongoing safety evaluation of Tysabri led to a previously diagnosed case of malignant astrocytoma being reassessed as PML, in a patient in an open label Crohn's disease clinical trial. The patient had received eight doses of Tysabri over an 18 month period. The patient died in December 2003.
We are working with leading experts, regulatory authorities and the clinical investigators to investigate these serious adverse events and to determine the appropriate path forward.
29. Business Ventures
From 1996 to mid 2001, we pursued collaborations with biotechnology, drug delivery and pharmaceutical companies in order to leverage our drug delivery technologies and our proprietary neurological and oncology research, and to access complementary or synergistic R&D programs in our areas of expertise. We have historically referred to this program in a number of ways, including as a joint venture program, a business venture program, and a strategic licensing program. For the purposes of these Consolidated Financial Statements, this program will be referred to as the "business venture program". We have not entered into any new business ventures under the business venture program since mid-2001.
In 2002, as part of the recovery plan, we completed a review of our business venture portfolio to conserve cash and reflect the reduced scope of our activities. As a result, we decided to restructure or terminate substantially all of our business ventures with the aim of substantially reducing or eliminating future cash outlays. The restructuring process and any terms agreed have been the result of negotiations with respective business venture parents. As such, the agreed terms arising from the restructuring process vary between different business venture relationships. Typically, as part of the termination of a business venture, the technologies contributed by the business venture parent and Elan are returned, the technology developed in the business venture is transferred to the business venture parent or Elan, and we transfer our interest in the business venture to the business venture parent in exchange for a continuing interest in the product or technology previously in the business venture, such as a royalty. There were approximately 55 business ventures in place prior to July 2002. All business ventures have been terminated, restructured or are now inactive. As a consequence, we do not expect to provide any additional financing to the business ventures and business venture parents.
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As all business ventures have been terminated, restructured or are now inactive, the description of the business venture program below is described in the past tense.
The business venture program generally involved licensing drug delivery technologies and pharmaceutical R&D assets, to a newly formed subsidiary of an emerging biotechnology; drug delivery or pharmaceutical company and the establishment of a joint development collaboration.
The business venture program generally involved licensing drug delivery technologies and know-how, or pharmaceutical R&D assets, to a newly formed subsidiary ("the business venture") of an emerging biotechnology, drug delivery or pharmaceutical company ("the business venture parent") and the establishment of a joint development collaboration.
Contemporaneously with the licensing and collaborative transaction, we typically made an investment in the business venture. Investments in business ventures were in various forms. Prior to mid-1999, those investments were generally in the form of voting common stock. Subsequently, these investments were in the form of non-voting preferred stock convertible into common stock after a period of two years. We typically held an initial fully diluted equity interest of 19.9% in the business venture. We also typically made a contemporaneous investment in the business venture parent in the form of common equity and convertible/exchangeable preferred stock or convertible/exchangeable debt. The convertible/exchangeable securities in the business venture parent were generally convertible, at our option, into common equity of the business venture parent or exchangeable for up to 30.1% of the common equity in the business venture, potentially bringing our fully diluted equity interest in the business venture up to 50%. In many transactions, if we chose to exchange the convertible/exchangeable securities in the business venture parent into common equity of the business venture, then we would be required to pay the business venture parent an amount equal to 30.1% of the cumulative operating funding of the business venture to the date of exchange such that we and the business venture parent would have shared equally (on a cumulative basis) in such funding. We sold certain of our investments in the business ventures and the business venture parents to EPIL II in June 2000 and to EPIL III in March 2001. EPIL II and EPIL III were securitization entities and the investments were held by EPIL II and EPIL III as security for outstanding indebtedness issued by the entities.
The business venture generally conducted R&D activities using its technologies and proprietary know-how in an agreed research field. Our partner, the business venture parent, principally managed the business venture. The technologies and proprietary know-how of the business venture were in-licensed by the business venture from us and the business venture parent. On formation, a number of contracts were entered into to govern the in-licensing of intellectual property assets to the business venture from us and the business venture parent.
Development of products and technologies for pharmaceutical applications involves risk. The nature of pharmaceutical development, with stringent regulatory constraints and guidelines designed to protect the health and safety of patients and those working with the products, means that development activities are costly and time consuming. Our portfolio of business ventures allowed us to diversify the risks associated with product development. Individual development programs within the business ventures had varying degrees of success and failure. We and the business venture parent would typically work together using commercially reasonable efforts and our combined technical, regulatory and clinical expertise to increase the likelihood of success of the business ventures. This could lead to changes in the direction of a development program, adding or substituting technologies or products and redirection of clinical programs as deemed necessary.
We and the business venture parent continually reviewed the progress of the R&D activities in the business venture. As part of this review, the parties could decide that it was not commercially or technically practical to continue to support the business venture.
The business ventures typically had the following operational structure. The board of directors of a business venture was generally comprised of a majority of directors from the business venture parent and one director nominated by us. For a quorum, the presence of our nominated director was required. The business plan required the approval of the board of directors of the business venture, including our nominated director. This approval was subject to the directors' fiduciary duty to the business venture. The contracts of establishment provided for subsequent reviews, either annually or more frequently, of the business plan and required the continuing approval by our nominated director. The business ventures also typically had a management committee or a R&D committee. These committees generally provided for equal representation by us and the business venture parent. The committees had responsibility for day-to-day activities of the business venture and for the implementation of the business plan. At their inception, the business ventures typically had no funds after payment of the initial fee to us. The operating funding of the business venture was provided by the
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business venture parent and Elan, subject to the approval of both parties. Funding was generally utilized to pay for R&D activities. Funding was typically provided in proportion to the respective fully-diluted ownership of the business venture by the business venture parent and us (typically 80.1% and 19.9%, respectively). We expensed the subsequent funding that we provided directly to the business venture. We expensed $Nil, $3.0 million, and $23.9 million of subsequent business venture funding in 2004, 2003 and 2002, respectively. We also made additional investments in the business venture parent in the form of convertible debt recorded as an investment. We provided additional financing of $Nil, $7.1 million, and $83.4 million to business venture parents in 2004, 2003 and 2002, respectively. All business ventures have been terminated, restructured or are now inactive and we do not expect to provide any additional financing to the business ventures and business venture parents.
The business ventures incurred R&D expenditures of approximately $Nil, $17.0 million and $125.0 million in 2004, 2003 and 2002, respectively. While the business ventures and the business venture parents were generally responsible for ongoing R&D activities, they could request that we conduct R&D on their behalf. We received research revenue from the business ventures of $Nil, $3.7 million and $13.4 million in 2004, 2003 and 2002, respectively. In addition, we recognized license fee revenue from the business ventures of $Nil, $35.2 million and $203.8 million in 2004, 2003 and 2002, respectively. There were no remaining unamortized license fees at December 31, 2004 and 2003. We do not expect to receive any future research revenues from the business ventures.
Investments in the business ventures and the business venture parents were made at fair value. The fair value of investments was typically initially determined using established financial methodologies, including quoted market prices for quoted equity securities. Unquoted equity investments and non-traded securities of public entities were assessed using methodologies including the Black-Scholes option-pricing model, the valuation achieved in the most recent private placement by an investee, an assessment of the impact of general private equity market conditions, and discounted projected future cash flow models.
Subsequent to our investment in a business venture and business venture parent, the fair values of the investments have been typically determined periodically, by an independent financial institution using methodologies similar to those described above.
We recognized impairments to our investment portfolio, including investments held by EPIL III. This includes impairment charges relating to investments in business ventures and business venture parent companies of $0.2 million, $4.0 million and $114.4 million in 2004, 2003 and 2002, respectively, and $58.6 million, $106.0 million and $880.0 million in 2004, 2003 and 2002, respectively.
30. Risk-Sharing Arrangements
Pharma Marketing
In June 2000, we disposed of royalty rights on certain products and development projects to Pharma Marketing. Pharma Marketing completed a private placement of its common shares to a group of institutional investors, resulting in gross proceeds of $275.0 million. We held no investment in Pharma Marketing and had no representative on its board of directors. Concurrent with the private placement, we entered into a Program Agreement with Pharma Marketing. The Program Agreement, which substantially regulated the relationship, was a risk-sharing arrangement. Under the terms of the Program Agreement, Pharma Marketing acquired certain royalty rights to each of the following products for the designated indications (including any other product that contained the active ingredient included in such product for any other designation): (i) Frova, for the treatment of migraines; (ii) Myobloc, for the treatment of cervical dystonia; (iii) Prialt, for the treatment of acute pain and severe chronic pain; (iv) Zanaflex, for the treatment of spasticity and painful spasms; and (v) Zonegran, for the treatment of epilepsy. Pharma Marketing agreed to make payments to us in amounts equal to expenditures incurred by us in connection with the commercialization and development of these products, subject to certain limitations. These payments were made on a quarterly basis based on the actual costs incurred by us. We did not receive a margin on these payments.
We received no revenue from Pharma Marketing in 2004 or 2003. Revenue from Pharma Marketing was $31.3 million in 2002, consisting of $24.0 million for commercialization expenditures, which was recorded as product revenue, and $7.3 million for development expenditures, which was recorded as contract revenue. Pursuant to the Program Agreement, Pharma Marketing utilized all of its available funding by mid-2002. We will not receive any future revenue from Pharma
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Marketing. In 2003, the royalty rate on net sales of all designated products was 28% on the first $122.9 million of net sales and 53% for net sales above $122.9 million. In 2002, the royalty rate on net sales of all designated products was 16% on the first $122.9 million of net sales and 4% for net sales above $122.9 million. We paid aggregate royalties of $43.3 million in 2003 (2002: $24.1 million) recorded as a cost of sales.
In December 2001, the Program Agreement was amended such that we re-acquired the royalty rights to Myobloc and disposed of the royalty rights of Sonata to Pharma Marketing. The amendment was transacted at estimated fair value. The board of directors and shareholders of Pharma Marketing approved this amendment. The estimated difference in relative fair value between the royalty rights of Sonata and the royalty rights of Myobloc was $60.0 million. We paid this amount to Pharma Marketing in cash and capitalized it as an intangible asset.
Under the original agreements, we could have, at our option at any time prior to June 30, 2003, acquired the royalty rights by initiating an auction process. This date was extended to January 3, 2005 under the settlement with Pharma Marketing and its subsidiary, Pharma Operating Ltd. ("Pharma Operating"), described below. In addition, the holders of Pharma Marketing common shares were entitled to initiate the auction process earlier upon the occurrence of certain events. Pursuant to the auction process, the parties were to negotiate in good faith to agree on a purchase price, subject to our right to re-acquire the royalty rights at a maximum purchase price. The maximum purchase price was approximately $413.0 million at December 31, 2002 and increased by approximately 25% annually (less royalty payments). The purchase price was reduced under the settlement with Pharma Marketing and Pharma Operating described below.
In January 2003, Pharma Operating filed a lawsuit in the Supreme Court of the State of New York against us and certain of our subsidiaries in connection with the risk-sharing arrangement between the parties. The lawsuit sought, among other things, a court determination that Pharma Operating's approval would be required in the event we sell our interest in Sonata to a third party. On January 30, 2003, we settled the lawsuit and, under the terms of the settlement agreement, Pharma Operating dismissed the litigation between the parties without prejudice. Pursuant to the settlement agreement, effective upon the sale of Sonata to King in June 2003: (1) we paid Pharma Operating $196.4 million in cash (representing $225.0 million less royalty payments on all related products paid or due to Pharma Operating from January 1, 2003 through June 12, 2003) to acquire Pharma Operating's royalty rights with respect to Sonata and Prialt; and (2) our maximum purchase price for the remaining products in the arrangement, Zonegran, Frova and Zanaflex, was reduced to $110.0 million, which increased at a rate of 15% per annum from June 12, 2003 (less royalty payments made for periods after June 12, 2003). The parties also agreed to extend our purchase option termination date to January 3, 2005 from the original termination date of June 30, 2003.
In connection with the settlement agreement, we agreed that we would cause certain subsidiaries in the United States, Ireland, the United Kingdom, Germany, France, Spain and Italy to pledge their accounts receivable from commercial sales of pharmaceutical products and services to Pharma Operating as collateral to secure our obligations in relation to royalty payments under the Pharma Marketing arrangement and the settlement agreement. We also agreed that, following the closing of a sale of Sonata, we would grant Pharma Operating additional collateral to the extent that the aggregate value of the collateral package, which was to be tested on a quarterly basis, was less than the maximum purchase price for the royalty rights on Zonegran, Frova and Zanaflex. On March 6, 2003, EPI and Pharma Operating entered into a security agreement pursuant to which EPI granted Pharma Operating a first priority security interest in its accounts receivable from commercial sales of pharmaceutical products in the United States. On that same date, we agreed to the terms of the additional collateral mechanism. On May 20, 2003, EPL and Pharma Operating entered into a security agreement pursuant to which EPL granted Pharma Operating a security interest in its accounts receivable from commercial sales of pharmaceutical products and services in the United Kingdom. A similar agreement was entered into in relation to Ireland by Elan Pharma Limited (Ireland) on June 10, 2003.
In November 2003, we exercised our option to purchase the remaining royalty rights of Zonegran, Frova and Zanaflex from Pharma Operating for $101.2 million and all of its agreements with Pharma Marketing were terminated. During 2003, we expensed $297.6 million for the acquisition of royalty rights from Pharma Operating.
Autoimmune
In December 2001, Autoimmune completed a private placement of its common shares to a group of institutional investors, resulting in gross proceeds to Autoimmune of $95.0 million. In the same initial tranche, we purchased non-voting preferred shares of Autoimmune's subsidiary for an aggregate purchase price of $37.5 million. We had no representative on the board of directors of Autoimmune. We also committed to a second investment in the same
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amounts to be completed in April 2003, subject to certain conditions. The related Program Agreement was a risk-sharing arrangement among the companies. Under the terms of the Program Agreement, Autoimmune acquired royalty rights to each of the following products and development projects for the designated indications: (i) Tysabri, for the treatment of relapsing forms of MS, moderate-to-severe inflammatory bowel disease, including Crohn's disease and ulcerative colitis, and moderate-to-severe rheumatoid arthritis; (ii) Maxipime, for the treatment of infection; (iii) Azactam, for the treatment of infection; and (iv) Abelcet, for the treatment of severe fungal infection. Autoimmune also acquired royalty rights on certain development projects, as well as any other product subsequently developed or acquired by us that had an indication substantially the same as Maxipime, Azactam or Abelcet and that would be in direct competition with Maxipime, Azactam or Abelcet. Autoimmune agreed to make payments to us in amounts equal to expenditures we incurred in connection with the commercialization and development of these products, subject to certain limitations. These payments were to be made on a quarterly basis based on actual costs incurred by us. We did not receive a margin on these payments. Our revenue from Autoimmune was $68.7 million for 2002, consisting of $38.8 million for commercialization expenditures, which has been recorded as product revenue, and $29.9 million for development expenditures, which has been recorded as contract revenue. We have received no revenue from Autoimmune since June 2002. We will not receive any future revenue from Autoimmune. No royalties were payable to Autoimmune by us in 2004, 2003, or 2002.
Under the original agreement, we could, at our option at any time prior to April 2005, acquire the royalty rights by initiating an auction process. In addition, the holders of the Autoimmune common shares could initiate the auction process earlier upon the occurrence of certain events. If the auction process had not been initiated prior to October 2004, it would have automatically commenced. Pursuant to the auction process, we and Autoimmune would have negotiated in good faith to agree on a purchase price, subject to our right to re-acquire the royalty rights at a maximum purchase price. This maximum purchase price increased at various rates, approximately 25% annually, subject to certain conditions.
In July 2002, we terminated all risk-sharing arrangement with Autoimmune and the royalty obligations to Autoimmune were terminated. The total consideration for the royalty rights was $121.0 million, less our investment of $38.5 million, resulted in a net cash cost of $82.5 million. We expensed $121.0 million for the acquisition of royalty rights from Autoimmune.
31. Segment Information
During 2003, our business was conducted through two business units, Core Elan and Elan Enterprises. With the completion of the recovery plan on February 12, 2004, we announced the end of operations for our Elan Enterprises business unit. In February 2004, we reorganized into two business units: Biopharmaceuticals and GS&O. In this reorganization, our Core Elan business, with the exception of its drug delivery business, now forms the Biopharmaceuticals business unit. The remaining businesses in Elan Enterprises, comprising principally drug delivery businesses, were amalgamated with the drug delivery business from Core Elan to form GS&O.
Biopharmaceuticals engages in biopharmaceutical R&D activities and pharmaceutical commercial activities. Biopharmaceutical R&D activities include the discovery and development of products in the therapeutic areas of neurodegenerative diseases, autoimmune diseases and severe pain. Our pharmaceutical commercial activities include the marketing of neurodegenerative and pain management products and hospital products. GS&O focuses on product development and manufacturing to provide technology platforms that address the drug delivery challenges of the pharmaceutical industry. All prior period financial information has been reclassified to reflect the new basis of segmentation.
Revenue by region (by destination of customers)
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
| | (in millions) |
Region: | | | | | | | | | | | | |
Ireland | | $ | 17.2 | | | $ | 24.3 | | | $ | 33.0 | |
United States | | | 401.3 | | | | 527.7 | | | | 775.7 | |
Rest of World | | | 63.2 | | | | 133.6 | | | | 284.4 | |
Total revenue | | $ | 481.7 | | | $ | 685.6 | | | $ | 1,093.1 | |
|
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Distribution of operating loss by region
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
| | (in millions) |
Ireland | | $ | (56.5 | ) | | $ | (264.8 | ) | | $ | (492.4 | ) |
United States | | | (172.7 | ) | | | (35.5 | ) | | | (101.8 | ) |
Rest of World | | | (72.9 | ) | | | (60.2 | ) | | | (14.5 | ) |
Total operating loss | | $ | (302.1 | ) | | $ | (360.5 | ) | | $ | (608.7 | ) |
|
Total assets by region
| | | | | | | | | | | | | | |
| | | | 2004 | | 2003 |
| | | | (in millions) |
Ireland | | | | | | $ | 827.7 | | | $ | 906.1 | |
United States | | | | | | | 780.6 | | | | 872.1 | |
Bermuda | | | | | | | 1,326.9 | | | | 1,084.9 | |
Rest of World | | | | | | | 40.7 | | | | 166.7 | |
Total assets | | | | | | $ | 2,975.9 | | | $ | 3,029.8 | |
|
Property, plant and equipment by region
| | | | | | | | | | | | | | |
| | | | 2004 | | 2003 |
| | | | (in millions) |
Ireland | | | | | | $ | 238.0 | | | $ | 223.5 | |
United States | | | | | | | 105.6 | | | | 143.5 | |
Bermuda | | | | | | | 0.1 | | | | 0.1 | |
Rest of World | | | | | | | 2.5 | | | | 2.0 | |
Total property, plant and equipment | | | | | | $ | 346.2 | | | $ | 369.1 | |
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Major customers
The following three customers each contributed 10% or more of our operating revenue for 2004, 2003 and 2002:
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
McKesson Corporation | | | 19 | % | | | 18 | % | | | 15 | % |
AmerisourceBergen | | | 19 | % | | | 17 | % | | | 16 | % |
Cardinal Health | | | 18 | % | | | 22 | % | | | 17 | % |
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No other customer accounted for more than 10% of our revenue in 2004, 2003 or 2002.
Analysis by segment
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Biopharmaceuticals | | GS&O | | Total |
| | 2004 | | 2003 | | 2002 | | 2004 | | 2003 | | 2002 | | 2004 | | 2003 | | 2002 |
| | (in millions) | | (in millions) | | (in millions) |
Revenue | | $ | 275.1 | | | $ | 479.7 | | | $ | 688.5 | | | $ | 206.6 | | | $ | 205.9 | | | $ | 404.6 | | | $ | 481.7 | | | $ | 685.6 | | | $ | 1,093.1 | |
Gain (loss) on sale of businesses | | $ | 41.2 | | | $ | 271.2 | | | $ | — | | | $ | 3.0 | | | $ | (3.4 | ) | | $ | — | | | $ | 44.2 | | | $ | 267.8 | | | $ | — | |
Depreciation and amortization (i) | | $ | 78.8 | | | $ | 90.3 | | | $ | 89.8 | | | $ | 42.4 | | | $ | 43.2 | | | $ | 45.8 | | | $ | 121.2 | | | $ | 133.5 | | | $ | 135.6 | |
Restructuring and other charges, net (ii) | | $ | 0.2 | | | $ | 343.7 | | | $ | 319.1 | | | $ | 1.3 | | | $ | 13.9 | | | $ | 127.0 | | | $ | 1.5 | | | $ | 357.6 | | | $ | 446.1 | |
Operating income/ (loss) (iii) | | $ | (253.2 | ) | | $ | (318.1 | ) | | $ | (582.8 | ) | | $ | 14.2 | | | $ | 5.7 | | | $ | 32.9 | | | $ | (239.0 | ) | | $ | (312.4 | ) | | $ | (549.9 | ) |
Capital expenditures (iv) | | $ | 17.1 | | | $ | 12.3 | | | $ | 51.0 | | | $ | 41.8 | | | $ | 22.2 | | | $ | 129.1 | | | $ | 58.9 | | | $ | 34.5 | | | $ | 180.1 | |
|
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(i) Reconciliation of depreciation & amortization (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Segmental depreciation and amortization | | $ | 121.2 | | | $ | 133.5 | | | $ | 135.6 | |
Corporate depreciation and amortization | | | 1.2 | | | | 2.4 | | | | 2.7 | |
| | $ | 122.4 | | | $ | 135.9 | | | $ | 138.3 | |
|
(ii) Reconciliation of restructuring and other charges (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Segmental other charges | | $ | 1.5 | | | $ | 357.6 | | | $ | 446.1 | |
Corporate other charges | | | 58.3 | | | | 45.6 | | | | 54.6 | |
Restructuring and other charges, net | | $ | 59.8 | | | $ | 403.2 | | | $ | 500.7 | |
|
Corporate other charges relate primarily to litigation provisions and costs for the SEC investigation and shareholder class action lawsuits in 2004, severance, relocation and exit costs and EPIL II/III waiver fee in 2003, and primarily severance, relocation and exit costs in 2002.
(iii) Reconciliation of operating loss (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Segmental operating loss | | $ | (239.0 | ) | | $ | (312.4 | ) | | $ | (549.9 | ) |
Corporate expense/(credit) | | | 63.1 | | | | 48.1 | | | | 58.8 | |
Operating loss (v) | | $ | (302.1 | ) | | $ | (360.5 | ) | | $ | (608.7 | ) |
|
Segmental operating income/(loss) is shown after allocation of central administrative and other costs. Corporate expense/(credit) relates primarily to litigation provisions and costs for the SEC investigation and shareholder class action lawsuits in 2004, severance, relocation and exit costs and EPIL II/III waiver fee in 2003, and primarily severance, relocation and exit costs in 2002.
(iv) Reconciliation of capital expenditures (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Segmental capital expenditures | | $ | 58.9 | | | $ | 34.5 | | | $ | 180.1 | |
Corporate capital expenditures | | | 6.2 | | | | 0.3 | | | | 2.2 | |
| | $ | 65.1 | | | $ | 34.8 | | | $ | 182.3 | |
|
(v) Reconciliation of operating loss to net loss (in millions):
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | 2002 |
Operating loss | | $ | (302.1 | ) | | $ | (360.5 | ) | | $ | (608.7 | ) |
Net interest and investment losses | | | (112.1 | ) | | | (136.9 | ) | | | (1,552.9 | ) |
Provision for income taxes | | | 0.5 | | | | 22.8 | | | | (8.0 | ) |
Net income/(loss) from discontinued operations | | | 19.0 | | | | (31.5 | ) | | | (188.6 | ) |
Net loss | | $ | (394.7 | ) | | $ | (506.1 | ) | | $ | (2,358.2 | ) |
|
Goodwill
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | |
Biopharmaceuticals | | $ | 218.3 | | | $ | 224.9 | | |
GS&O | | | 49.7 | | | | 49.7 | | |
Total goodwill | | $ | 268.0 | | | $ | 274.6 | | |
|
125
Total assets
| | | | | | | | | | | | | | |
| | 2004 | | 2003 | | |
Biopharmaceutical assets | | $ | 1,024.9 | | | $ | 1,352.2 | | |
GS&O assets | | | 612.4 | | | | 581.8 | | |
Corporate assets | | | 1,338.6 | | | | 1,095.8 | | |
Total assets | | $ | 2,975.9 | | | $ | 3,029.8 | | |
|
32. Supplemental Guarantor Information
As part of the offering and sale of the $850.0 million in aggregate principal amount of 7.75% Notes due November 15, 2011 and the $300.0 million Floating Rate Notes due November 15, 2011. Elan Corporation, plc and certain of our subsidiaries have guaranteed the 7.75% Notes and the Floating Rate Notes. Equivalent guarantees have also been given to the holders of the Athena Notes.
Presented below is consolidated information for Elan Finance plc, the issuer of the debt, Elan Corporation, plc, the parent guarantor of the debt, the guarantor subsidiaries of Elan Corporation, plc, listed below, and the non-guarantor subsidiaries of Elan Corporation, plc. All of the subsidiary guarantors are wholly owned subsidiaries of Elan Corporation, plc.
Elan Corporation, plc
Consolidating Statements of Operations
For the Year Ended December 31, 2004
(in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Elan Finance, plc | | Athena Finance | | Parent Company | | Guarantor Subsidiaries | | Non- Guarantor Subsidiaries | | Elimination Adjustment | | Consolidated |
Revenue | | $ | — | | | $ | — | | | $ | 67.3 | | | $ | 630.3 | | | $ | 3.8 | | | $ | (219.7 | ) | | $ | 481.7 | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Cost of sales | | | — | | | | — | | | | 8.3 | | | | 188.9 | | | | 1.7 | | | | (28.5 | ) | | | 170.4 | |
Selling, general and administrative expenses | | | — | | | | — | | | | 28.5 | | | | 306.8 | | | | 3.6 | | | | 1.6 | | | | 340.5 | |
Research and development expenses | | | — | | | | — | | | | 14.7 | | | | 425.1 | | | | 0.2 | | | | (182.7 | ) | | | 257.3 | |
Gain on sale of businesses | | | — | | | | — | | | | — | | | | 14.1 | | | | — | | | | (58.3 | ) | | | (44.2 | ) |
Restructuring and other charges, net | | | — | | | | — | | | | 72.1 | | | | (3.0 | ) | | | 0.1 | | | | (9.4 | ) | | | 59.8 | |
Total operating expenses | | | — | | | | — | | | | 123.6 | | | | 931.9 | | | | 5.6 | | | | (277.3 | ) | | | 783.8 | |
Operating income/(loss) | | | — | | | | — | | | | (56.3 | ) | | | (301.6 | ) | | | (1.8 | ) | | | 57.6 | | | | (302.1 | ) |
Net interest (income)/expense and investment (gains)/losses | | | 3.9 | | | | — | | | | 77.4 | | | | 73.4 | | | | (33.0 | ) | | | (9.6 | ) | | | 112.1 | |
Net income/(loss) from continuing operations before provision for/(benefit from) income taxes | | | (3.9 | ) | | | — | | | | (133.7 | ) | | | (375.0 | ) | | | 31.2 | | | | 67.2 | | | | (414.2 | ) |
Provision for/(benefit from) income taxes | | | — | | | | — | | | | — | | | | (2.2 | ) | | | 0.1 | | | | 1.6 | | | | (0.5 | ) |
Net income/(loss) from continuing operations | | | (3.9 | ) | | | — | | | | (133.7 | ) | | | (372.8 | ) | | | 31.1 | | | | 65.6 | | | | (413.7 | ) |
Net income/(loss) from discontinued operations (net of tax) | | | — | | | | — | | | | — | | | | 19.1 | | | | (0.1 | ) | | | — | | | | 19.0 | |
Net income/(loss) | | $ | (3.9 | ) | | $ | — | | | $ | (133.7 | ) | | $ | (353.7 | ) | | $ | 31.0 | | | $ | 65.6 | | | $ | (394.7 | ) |
|
126
Elan Corporation, plc
Consolidating Statements of Operations
For the Year Ended December 31, 2003
(in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Elan Finance, plc | | Athena Finance | | Parent Company | | Guarantor Subsidiaries | | Non- Guarantor Subsidiaries | | Elimination Adjustment | | Consolidated |
Revenue | | $ | — | | | $ | — | | | $ | 49.1 | | | $ | 837.9 | | | $ | 59.3 | | | $ | (260.7 | ) | | $ | 685.6 | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Cost of sales | | | — | | | | — | | | | 8.7 | | | | 331.7 | | | | 31.8 | | | | (123.3 | ) | | | 248.9 | |
Selling, general and administrative expenses | | | — | | | | — | | | | 4.4 | | | | 350.8 | | | | 28.9 | | | | 0.1 | | | | 384.2 | |
Research and development expenses | | | — | | | | — | | | | 13.6 | | | | 421.8 | | | | 8.3 | | | | (166.1 | ) | | | 277.6 | |
(Gain)/loss on sale of businesses | | | — | | | | — | | | | 0.4 | | | | (261.9 | ) | | | (2.2 | ) | | | (4.1 | ) | | | (267.8 | ) |
Restructuring and other charges, net | | | — | | | | — | | | | 92.6 | | | | 753.8 | | | | 47.8 | | | | (491.0 | ) | | | 403.2 | |
Total operating expenses | | | — | | | | — | | | | 119.7 | | | | 1,596.2 | | | | 114.6 | | | | (784.4 | ) | | | 1,046.1 | |
Operating income/(loss) | | | — | | | | — | | | | (70.6 | ) | | | (758.3 | ) | | | (55.3 | ) | | | 523.7 | | | | (360.5 | ) |
Net interest (income)/expense and investment (gains)/losses | | | — | | | | — | | | | 99.0 | | | | (8.1 | ) | | | (49.9 | ) | | | 95.9 | | | | 136.9 | |
Net income/(loss) from continuing operations before provision for/(benefit from) income taxes | | | — | | | | — | | | | (169.6 | ) | | | (750.2 | ) | | | (5.4 | ) | | | 427.8 | | | | (497.4 | ) |
Provision for/(benefit from) income taxes | | | — | | | | — | | | | — | | | | (0.5 | ) | | | — | | | | (22.3 | ) | | | (22.8 | ) |
Net income/(loss) from continuing operations | | | — | | | | — | | | | (169.6 | ) | | | (749.7 | ) | | | (5.4 | ) | | | 450.1 | | | | (474.6 | ) |
Net income/(loss) from discontinued operations (net of tax) | | | — | | | | — | | | | — | | | | (66.7 | ) | | | 35.2 | | | | — | | | | (31.5 | ) |
Net income/(loss) | | $ | — | | | $ | — | | | $ | (169.6 | ) | | $ | (816.4 | ) | | $ | 29.8 | | | $ | 450.1 | | | $ | (506.1 | ) |
|
Elan Corporation, plc
Consolidating Statements of Operations
For the Year Ended December 31, 2002
(in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Elan Finance, plc | | Athena Finance | | Parent Company | | Guarantor Subsidiaries | | Non- Guarantor Subsidiaries | | Elimination Adjustment | | Consolidated |
Revenue | | $ | — | | | $ | — | | | $ | 114.2 | | | $ | 1,668.3 | | | $ | 24.9 | | | $ | (714.3 | ) | | $ | 1,093.1 | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Cost of sales | | | — | | | | — | | | | 10.8 | | | | 550.2 | | | | 17.2 | | | | (272.6 | ) | | | 305.6 | |
Selling, general and administrative expenses | | | — | | | | — | | | | 28.0 | | | | 497.4 | | | | 19.6 | | | | (3.4 | ) | | | 541.6 | |
Research and development expenses | | | — | | | | — | | | | 38.5 | | | | 517.3 | | | | 4.9 | | | | (206.8 | ) | | | 353.9 | |
Restructuring and other charges, net | | | — | | | | — | | | | 5,794.2 | | | | 301.6 | | | | (29.0 | ) | | | (5,566.1 | ) | | | 500.7 | |
Total operating expenses | | | — | | | | — | | | | 5,871.5 | | | | 1,866.5 | | | | 12.7 | | | | (6,048.9 | ) | | | 1,701.8 | |
Operating income/(loss) | | | — | | | | — | | | | (5,757.3 | ) | | | (198.2 | ) | | | 12.2 | | | | 5,334.6 | | | | (608.7 | ) |
Net interest (income)/expense and investment (gains)/losses | | | — | | | | — | | | | 62.2 | | | | 766.3 | | | | 161.8 | | | | 562.6 | | | | 1,552.9 | |
Net income/(loss) from continuing operations before provision for /(benefit from) income taxes | | | — | | | | — | | | | (5,819.5 | ) | | | (964.5 | ) | | | (149.6 | ) | | | 4,772.0 | | | | (2,161.6 | ) |
Provision for/(benefit from) income taxes | | | — | | | | — | | | | 0.4 | | | | (0.1 | ) | | | 0.4 | | | | 7.3 | | | | 8.0 | |
Net income/(loss) from continuing operations | | | — | | | | — | | | | (5,819.9 | ) | | | (964.4 | ) | | | (150.0 | ) | | | 4,764.7 | | | | (2,169.6 | ) |
Net income/(loss) from discontinued operations (net of tax) | | | — | | | | — | | | | — | | | | (161.5 | ) | | | (27.1 | ) | | | — | | | | (188.6 | ) |
Net income/(loss) | | $ | — | | | $ | — | | | $ | (5,819.9 | ) | | $ | (1,125.9 | ) | | $ | (177.1 | ) | | $ | 4,764.7 | | | $ | (2,358.2 | ) |
|
127
In July 2002, we announced a recovery plan aimed at focusing our business and R&D activities and meeting our financial obligations. Elan Corporation, plc recorded a write-down to investments of $5,593.4 million in its single entity financial statements as a consequence of restructuring its business, reflected in an impairment charge to investments in, and loans to, subsidiary undertakings.
Elan Corporation, plc
Consolidating Balance Sheets
As of December 31, 2004
(in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Elan Finance, plc | | Athena Finance | | Parent Company | | Guarantor Subsidiaries | | Non- Guarantor Subsidiaries | | Elimination Adjustment | | Consolidated |
Assets | | | | | | | | | | | | | | | | | | | | | | | | | |
Current Assets | | | | | | | | | | | | | | | | | | | | | | | | | |
Cash and cash equivalents | | $ | 10.2 | | | $ | — | | | $ | 38.6 | | | $ | 1,293.5 | | | $ | 5.9 | | | $ | (0.6 | ) | | $ | 1,347.6 | |
Restricted cash | | | — | | | | — | | | | 40.0 | | | | — | | | | 124.3 | | | | — | | | | 164.3 | |
Accounts receivable, net | | | — | | | | — | | | | 8.9 | | | | 32.6 | | | | — | | | | — | | | | 41.5 | |
Marketable investment securities | | | — | | | | — | | | | — | | | | 20.5 | | | | — | | | | 45.0 | | | | 65.5 | |
Inventory | | | — | | | | — | | | | — | | | | 29.0 | | | | — | | | | — | | | | 29.0 | |
Intercompany receivables | | | 1,122.5 | | | | 666.7 | | | | 2,097.6 | | | | 5,105.3 | | | | 0.9 | | | | (8,993.0 | ) | | | — | |
Prepaid and other current assets | | | — | | | | — | | | | 1.3 | | | | 101.0 | | | | 12.8 | | | | (36.5 | ) | | | 78.6 | |
Total current assets | | | 1,132.7 | | | | 666.7 | | | | 2,186.4 | | | | 6,581.9 | | | | 143.9 | | | | (8,985.1 | ) | | | 1,726.5 | |
Property, plant and equipment | | | — | | | | — | | | | — | | | | 344.9 | | | | 1.3 | | | | — | | | | 346.2 | |
Goodwill and other intangible assets | | | — | | | | — | | | | 67.0 | | | | 314.4 | | | | 2.8 | | | | 396.6 | | | | 780.8 | |
Marketable investment securities | | | — | | | | — | | | | — | | | | 108.5 | | | | 6.9 | | | | (76.4 | ) | | | 39.0 | |
Investments in subsidiaries | | | — | | | | — | | | | 579.2 | | | | 10,236.1 | | | | — | | | | (10,815.3 | ) | | | — | |
Restricted Cash | | | — | | | | — | | | | — | | | | 28.4 | | | | — | | | | — | | | | 28.4 | |
Other assets | | | 26.3 | | | | 2.9 | | | | 1.4 | | | | 27.3 | | | | — | | | | (2.9 | ) | | | 55.0 | |
Total assets | | $ | 1,159.0 | | | $ | 669.6 | | | $ | 2,834.0 | | | $ | 17,641.5 | | | $ | 154.9 | | | $ | (19,483.1 | ) | | $ | 2,975.9 | |
Liabilities and Shareholders' Equity | | | | | | | | | | | | | | | | | | | | | | | | | |
Current Liabilities | | | | | | | | | | | | | | | | | | | | | | | | | |
Accounts payable | | $ | — | | | $ | — | | | $ | 1.8 | | | $ | 53.2 | | | $ | — | | | $ | — | | | $ | 55.0 | |
Accrued and other current liabilities | | | 11.4 | | | | 16.7 | | | | 59.9 | | | | (233.3 | ) | | | 347.9 | | | | 87.9 | | | | 290.5 | |
EPIL III notes | | | — | | | | — | | | | — | | | | — | | | | 39.0 | | | | — | | | | 39.0 | |
Deferred revenue | | | — | | | | — | | | | 25.0 | | | | 72.9 | | | | — | | | | (42.1 | ) | | | 55.8 | |
Intercompany payables | | | 1.5 | | | | — | | | | 2,264.8 | | | | 11,859.6 | | | | 110.7 | | | | (14,236.6 | ) | | | — | |
Total current liabilities | | | 12.9 | | | | 16.7 | | | | 2,351.5 | | | | 11,752.4 | | | | 497.6 | | | | (14,190.8 | ) | | | 440.3 | |
Long term and convertible debt | | | 1,150.0 | | | | 650.0 | | | | — | | | | 460.0 | | | | — | | | | — | | | | 2,260.0 | |
Deferred revenue | | | — | | | | — | | | | 21.7 | | | | — | | | | — | | | | 32.9 | | | | 54.6 | |
Other liabilities | | | — | | | | 2.9 | | | | 13.3 | | | | 62.2 | | | | — | | | | (62.4 | ) | | | 16.0 | |
Total liabilities | | | 1,162.9 | | | | 669.6 | | | | 2,386.5 | | | | 12,274.6 | | | | 497.6 | | | | (14,220.3 | ) | | | 2,770.9 | |
Shareholders' Equity | | | | | | | | | | | | | | | | | | | | | | | | | |
Ordinary shares | | | — | | | | — | | | | 22.6 | | | | 290.1 | | | | 1.9 | | | | (292.0 | ) | | | 22.6 | |
Additional paid-in capital | | | — | | | | — | | | | 4,796.4 | | | | 7,013.7 | | | | 110.4 | | | | (7,124.1 | ) | | | 4,796.4 | |
Treasury stock | | | — | | | | | | | | (17.4 | ) | | | — | | | | — | | | | — | | | | (17.4 | ) |
Accumulated deficit | | | (3.9 | ) | | | — | | | | (4,354.1 | ) | | | (1,954.1 | ) | | | (455.3 | ) | | | 2,162.7 | | | | (4,604.7 | ) |
Accumulated other comprehensive income/(loss) | | | — | | | | — | | | | — | | | | 17.2 | | | | 0.3 | | | | (9.4 | ) | | | 8.1 | |
Shareholders' equity | | | (3.9 | ) | | | — | | | | 447.5 | | | | 5,366.9 | | | | (342.7 | ) | | | (5,262.8 | ) | | | 205.0 | |
Total liabilities and shareholders' equity | | $ | 1,159.0 | | | $ | 669.6 | | | $ | 2,834.0 | | | $ | 17,641.5 | | | $ | 154.9 | | | $ | (19,483.1 | ) | | $ | 2,975.9 | |
|
128
Elan Corporation, plc
Consolidating Balance Sheets
As of December 31, 2003
(in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Elan Finance plc | | Athena Finance | | Parent Company | | Guarantor Subsidiaries | | Non- Guarantor Subsidiaries | | Elimination Adjustment | | Consolidated |
Assets | | | | | | | | | | | | | | | | | | | | | | | | | |
Current Assets | | | | | | | | | | | | | | | | | | | | | | | | | |
Cash and cash equivalents | | $ | — | | | $ | — | | | $ | 21.7 | | | $ | 736.9 | | | $ | 19.6 | | | $ | — | | | $ | 778.2 | |
Accounts receivable, net | | | — | | | | — | | | | 4.3 | | | | 47.4 | | | | 25.3 | | | | (39.1 | ) | | | 37.9 | |
Marketable investment securities | | | — | | | | — | | | | — | | | | 111.9 | | | | 63.7 | | | | 173.8 | | | | 349.4 | |
Inventory | | | — | | | | — | | | | — | | | | 84.8 | | | | 8.9 | | | | (24.2 | ) | | | 69.5 | |
Held for sale assets | | | — | | | | — | | | | — | | | | — | | | | — | | | | 135.2 | | | | 135.2 | |
Intercompany receivables | | | — | | | | 666.7 | | | | 2,038.0 | | | | 3,605.0 | | | | 2.5 | | | | (6,312.2 | ) | | | — | |
Prepaid and other current assets | | | — | | | | | | | | 1.7 | | | | 79.0 | | | | 1.9 | | | | 41.6 | | | | 124.2 | |
Total current assets | | | — | | | | 666.7 | | | | 2,065.7 | | | | 4,665.0 | | | | 121.9 | | | | (6,024.9 | ) | | | 1,494.4 | |
Property, plant and equipment | | | — | | | | — | | | | 14.4 | | | | 354.5 | | | | 15.3 | | | | (15.1 | ) | | | 369.1 | |
Goodwill and other intangible assets | | | — | | | | — | | | | 86.5 | | | | 412.0 | | | | 20.9 | | | | 388.4 | | | | 907.8 | |
Marketable investment securities | | | — | | | | — | | | | — | | | | 328.4 | | | | 36.4 | | | | (171.9 | ) | | | 192.9 | |
Investments in subsidiaries | | | — | | | | — | | | | 541.5 | | | | 10,373.2 | | | | — | | | | (10,914.7 | ) | | | — | |
Restricted cash | | | — | | | | — | | | | — | | | | 33.1 | | | | — | | | | — | | | | 33.1 | |
Other assets | | | — | | | | 3.9 | | | | 3.5 | | | | 28.4 | | | | 0.4 | | | | (3.7 | ) | | | 32.5 | |
Total assets | | $ | — | | | $ | 670.6 | | | $ | 2,711.6 | | | $ | 16,194.6 | | | $ | 194.9 | | | $ | (16,741.9 | ) | | $ | 3,029.8 | |
Liabilities and Shareholders' Equity | | | | | | | | | | | | | | | | | | | | | | | | | |
Current Liabilities | | | | | | | | | | | | | | | | | | | | | | | | | |
Accounts payable | | $ | — | | | $ | — | | | $ | 1.3 | | | $ | 27.0 | | | $ | 4.4 | | | $ | (6.5 | ) | | $ | 26.2 | |
Accrued and other current liabilities | | | — | | | | 16.7 | | | | 6.5 | | | | 205.5 | | | | 11.5 | | | | 97.0 | | | | 337.2 | |
EPIL II guarantee provision | | | — | | | | — | | | | 344.5 | | | | — | | | | — | | | | — | | | | 344.5 | |
Deferred revenue | | | — | | | | — | | | | 25.0 | | | | 18.1 | | | | — | | | | 18.4 | | | | 61.5 | |
Intercompany payables | | | — | | | | — | | | | 1,764.8 | | | | 9,690.4 | | | | 22.4 | | | | (11,477.6 | ) | | | — | |
Held for sale liabilities | | | — | | | | — | | | | — | | | | — | | | | — | | | | 27.9 | | | | 27.9 | |
Total current liabilities | | | — | | | | 16.7 | | | | 2,142.1 | | | | 9,941.0 | | | | 38.3 | | | | (11,340.8 | ) | | | 797.3 | |
Long term and convertible debt | | | — | | | | 650.0 | | | | — | | | | 460.0 | | | | 390.0 | | | | — | | | | 1,500.0 | |
Deferred revenue | | | — | | | | — | | | | 46.7 | | | | — | | | | — | | | | 46.6 | | | | 93.3 | |
Other liabilities | | | — | | | | 3.9 | | | | 13.8 | | | | 66.4 | | | | 0.1 | | | | (62.9 | ) | | | 21.3 | |
Total liabilities | | | — | | | | 670.6 | | | | 2,202.6 | | | | 10,467.4 | | | | 428.4 | | | | (11,357.1 | ) | | | 2,411.9 | |
Shareholders' Equity | | | | | | | | | | | | | | | | | | | | | | | | | |
Ordinary shares | | | — | | | | — | | | | 22.0 | | | | 267.6 | | | | 17.0 | | | | (284.6 | ) | | | 22.0 | |
Additional paid-in capital | | | — | | | | — | | | | 4,724.8 | | | | 7,031.2 | | | | 261.5 | | | | (7,292.7 | ) | | | 4,724.8 | |
Treasury stock | | | — | | | | — | | | | (17.4 | ) | | | — | | | | — | | | | — | | | | (17.4 | ) |
Accumulated deficit | | | — | | | | — | | | | (4,220.4 | ) | | | (1,600.4 | ) | | | (486.3 | ) | | | 2,097.1 | | | | (4,210.0 | ) |
Accumulated other comprehensive income/(loss) | | | — | | | | — | | | | — | | | | 28.8 | | | | (25.7 | ) | | | 95.4 | | | | 98.5 | |
Shareholders' equity | | | — | | | | — | | | | 509.0 | | | | 5,727.2 | | | | (233.5 | ) | | | (5,384.8 | ) | | | 617.9 | |
Total liabilities and shareholders' equity | | $ | — | | | $ | 670.6 | | | $ | 2,711.6 | | | $ | 16,194.6 | | | $ | 194.9 | | | $ | (16,741.9 | ) | | $ | 3,029.8 | |
|
129
Elan Corporation, plc
Consolidating Statement of Cash Flows
For the Year Ended December 31, 2004
(in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Elan Finance, plc | | Athena Finance | | Parent Company | | Guarantor Subsidiaries | | Non- Guarantor Subsidiaries | | Elimination | | Consolidated |
Cash flows from operating activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Net income/(loss) | | $ | (3.9 | ) | | $ | — | | | $ | (133.7 | ) | | $ | (353.7 | ) | | $ | 31.0 | | | $ | 65.6 | | | $ | (394.7 | ) |
Adjustments to reconcile net income/(loss) to net cash provided by operating activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Amortization of deferred revenue | | | — | | | | — | | | | (25.0 | ) | | | (18.9 | ) | | | — | | | | (11.7 | ) | | | (55.6 | ) |
Amortization of financing costs | | | 0.5 | | | | — | | | | — | | | | 5.0 | | | | — | | | | — | | | | 5.5 | |
Depreciation and amortization | | | — | | | | — | | | | 13.0 | | | | 97.3 | | | | 1.5 | | | | 11.8 | | | | 123.6 | |
Gain on sale of investments | | | — | | | | — | | | | — | | | | (34.3 | ) | | | — | | | | (80.3 | ) | | | (114.6 | ) |
Impairment of investments | | | — | | | | — | | | | — | | | | 20.2 | | | | — | | | | 51.6 | | | | 71.8 | |
Provision for EPIL II guarantee | | | — | | | | — | | | | 47.1 | | | | — | | | | — | | | | — | | | | 47.1 | |
Disposals/write-down of other assets | | | — | | | | — | | | | 6.5 | | | | (28.0 | ) | | | 31.7 | | | | — | | | | 10.2 | |
Gain on sale of business | | | — | | | | — | | | | — | | | | (55.7 | ) | | | — | | | | — | | | | (55.7 | ) |
Receipts from sale of product rights | | | — | | | | — | | | | — | | | | 16.5 | | | | — | | | | — | | | | 16.5 | |
Other | | | — | | | | — | | | | — | | | | 23.0 | | | | — | | | | — | | | | 23.0 | |
Net changes in assets and liabilities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Decrease/(increase) in accounts receivables | | | — | | | | — | | | | (4.6 | ) | | | 24.3 | | | | 25.3 | | | | (39.1 | ) | | | 5.9 | |
Decrease/(increase) in intercompany receivables | | | (1,122.5 | ) | | | — | | | | (59.6 | ) | | | (1,500.3 | ) | | | 1.6 | | | | 2,680.8 | | | | — | |
Decrease/(increase) in prepaid and other assets | | | — | | | | | | | | (23.1 | ) | | | (146.8 | ) | | | (10.5 | ) | | | 159.1 | | | | (21.3 | ) |
Decrease/(increase) in inventory | | | — | | | | — | | | | — | | | | 32.4 | | | | 8.9 | | | | (24.2 | ) | | | 17.1 | |
(Decrease)/increase in accounts payable and accruals | | | 11.0 | | | | — | | | | 53.9 | | | | (83.2 | ) | | | (19.2 | ) | | | 10.8 | | | | (26.7 | ) |
(Decrease)/increase in intercompany payables | | | — | | | | — | | | | 110.0 | | | | 2,578.6 | | | | 88.3 | | | | (2,776.9 | ) | | | — | |
(Decrease)/increase in other liabilities | | | | | | | — | | | | (0.5 | ) | | | 386.1 | | | | — | | | | (385.6 | ) | | | — | |
Net cash provided by/(used in) operating activities | | | (1,114.9 | ) | | | — | | | | (16.0 | ) | | | 962.5 | | | | 158.6 | | | | (338.1 | ) | | | (347.9 | ) |
Cash flows from investing activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Proceeds from disposal of property, plant and equipment | | | — | | | | — | | | | — | | | | 44.2 | | | | — | | | | — | | | | 44.2 | |
Purchase of property, plant and equipment | | | — | | | | — | | | | — | | | | (56.9 | ) | | | (1.0 | ) | | | — | | | | (57.9 | ) |
Purchase of investments | | | — | | | | — | | | | — | | | | (1.4 | ) | | | — | | | | — | | | | (1.4 | ) |
Proceeds from disposal of investments | | | — | | | | — | | | | — | | | | 76.6 | | | | — | | | | — | | | | 76.6 | |
Sale and maturity of marketable investment securities | | | — | | | | — | | | | — | | | | 210.0 | | | | (31.1 | ) | | | — | | | | 178.9 | |
Purchase of intangible assets | | | — | | | | — | | | | — | | | | (41.1 | ) | | | — | | | | — | | | | (41.1 | ) |
Proceeds from disposal of intangible assets | | | — | | | | — | | | | — | | | | 0.3 | | | | — | | | | — | | | | 0.3 | |
Proceeds from business disposals | | | — | | | | — | | | | — | | | | 274.6 | | | | — | | | | — | | | | 274.6 | |
Net cash provided by/(used in) investing activities | | | — | | | | — | | | | — | | | | 506.3 | | | | (32.1 | ) | | | — | | | | 474.2 | |
Cash flows from financing activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Proceeds from sale of share capital | | | — | | | | — | | | | 70.6 | | | | — | | | | — | | | | — | | | | 70.6 | |
Payment under EPIL II guarantee | | | — | | | | — | | | | — | | | | (391.8 | ) | | | — | | | | — | | | | (391.8 | ) |
Repayment of EPIL III Notes | | | — | | | | — | | | | — | | | | (351.0 | ) | | | — | | | | — | | | | (351.0 | ) |
Repayment of loans | | | — | | | | — | | | | — | | | | (11.4 | ) | | | — | | | | — | | | | (11.4 | ) |
Net proceeds from debt issuance | | | 1,125.1 | | | | — | | | | — | | | | — | | | | — | | | | — | | | | 1,125.1 | |
Intercompany investments | | | — | | | | — | | | | (37.7 | ) | | | (159.6 | ) | | | (140.2 | ) | | | 337.5 | | | | — | |
Net cash provided by/(used in) financing activities | | | 1,125.1 | | | | — | | | | 32.9 | | | | (913.8 | ) | | | (140.2 | ) | | | 337.5 | | | | 441.5 | |
Effect of exchange rate changes on cash | | | — | | | | — | | | | — | | | | 1.6 | | | | — | | | | — | | | | 1.6 | |
Net increase/(decrease) in cash and cash equivalents | | | 10.2 | | | | — | | | | 16.9 | | | | 556.6 | | | | (13.7 | ) | | | (0.6 | ) | | | 569.4 | |
Cash and cash equivalents at beginning of year | | | — | | | | — | | | | 21.7 | | | | 736.9 | | | | 19.6 | | | | — | | | | 778.2 | |
Cash and cash equivalents at end of year | | $ | 10.2 | | | $ | — | | | $ | 38.6 | | | $ | 1,293.5 | | | $ | 5.9 | | | $ | (0.6 | ) | | $ | 1,347.6 | |
|
130
Elan Corporation, plc
Consolidating Statement of Cash Flows
For the Year Ended December 31, 2003
(in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Elan Finance, plc | | Athena Finance | | Parent Company | | Guarantor Subsidiaries | | Non- Guarantor Subsidiaries | | Elimination | | Consolidated |
Cash flows from operating activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Net income/(loss) | | $ | — | | | $ | — | | | $ | (169.6 | ) | | $ | (816.4 | ) | | $ | 29.8 | | | $ | 450.1 | | | $ | (506.1 | ) |
Adjustments to reconcile net loss to | | | | | | | | | | | | | | | | | | | | | | | | | |
net cash provided by operating activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Amortization of deferred revenue | | | — | | | | — | | | | (25.0 | ) | | | (4.9 | ) | | | — | | | | (57.6 | ) | | | (87.5 | ) |
Amortization of financing costs | | | — | | | | — | | | | — | | | | 12.5 | | | | — | | | | 1.1 | | | | 13.6 | |
Depreciation and amortization | | | — | | | | — | | | | 18.7 | | | | 128.0 | | | | 6.6 | | | | 20.8 | | | | 174.1 | |
(Gain)/loss on sale of investments | | | — | | | | — | | | | — | | | | 78.9 | | | | — | | | | (182.3 | ) | | | (103.4 | ) |
Impairment of investments | | | — | | | | — | | | | — | | | | 65.1 | | | | 22.4 | | | | — | | | | 87.5 | |
Provision for EPIL II guarantee | | | — | | | | — | | | | 49.0 | | | | — | | | | — | | | | — | | | | 49.0 | |
Disposals/write-down of other assets | | | — | | | | — | | | | 4.3 | | | | (8.0 | ) | | | 17.6 | | | | 58.3 | | | | 72.2 | |
Purchase of product royalty rights | | | — | | | | — | | | | — | | | | 297.6 | | | | — | | | | — | | | | 297.6 | |
Gain on sale of business | | | — | | | | — | | | | — | | | | (290.7 | ) | | | — | | | | — | | | | (290.7 | ) |
Gain on repurchase of LYONs | | | — | | | | — | | | | — | | | | (1.6 | ) | | | — | | | | — | | | | (1.6 | ) |
Fee to EPIL II/III noteholders | | | — | | | | — | | | | — | | | | 16.8 | | | | — | | | | — | | | | 16.8 | |
Receipts from sale of product rights | | | — | | | | — | | | | — | | | | 79.0 | | | | — | | | | — | | | | 79.0 | |
Other | | | — | | | | — | | | | — | | | | (34.0 | ) | | | — | | | | 8.8 | | | | (25.2 | ) |
Net changes in assets and liabilities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Decrease/(increase) in accounts receivables | | | — | | | | — | | | | 7.4 | | | | 24.5 | | | | (3.6 | ) | | | (15.0 | ) | | | 13.3 | |
Decrease/(increase) in intercompany receivables | | | — | | | | — | | | | 694.8 | | | | 17.0 | | | | 676.0 | | | | (1,387.8 | ) | | | — | |
Decrease/(increase) in prepaid and other assets | | | — | | | | — | | | | 2.8 | | | | 48.2 | | | | 1.0 | | | | (35.2 | ) | | | 16.8 | |
Decrease/(increase) in inventory | | | — | | | | — | | | | — | | | | (32.4 | ) | | | 48.8 | | | | (6.5 | ) | | | 9.9 | |
Decrease in accounts payable and accruals | | | — | | | | — | | | | (10.1 | ) | | | (181.6 | ) | | | (20.5 | ) | | | (31.6 | ) | | | (243.8 | ) |
(Decrease)/increase in intercompany payables | | | — | | | | — | | | | (637.5 | ) | | | (224.6 | ) | | | (748.8 | ) | | | 1,610.9 | | | | — | |
Net cash provided by/(used in) operating activities | | | — | | | | — | | | | (65.2 | ) | | | (826.6 | ) | | | 29.3 | | | | 434.0 | | | | (428.5 | ) |
Cash flows from investing activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Proceeds from disposal of property, plant and equipment | | | — | | | | — | | | | — | | | | 27.9 | | | | — | | | | — | | | | 27.9 | |
Purchase of property, plant and equipment | | | — | | | | — | | | | — | | | | (33.0 | ) | | | (0.7 | ) | | | — | | | | (33.7 | ) |
Purchase of investments | | | — | | | | — | | | | — | | | | (11.8 | ) | | | — | | | | — | | | | (11.8 | ) |
Proceeds from disposal of investments | | | — | | | | — | | | | — | | | | 53.1 | | | | — | | | | — | | | | 53.1 | |
Purchase of marketable investment securities | | | — | | | | — | | | | — | | | | (2.1 | ) | | | — | | | | — | | | | (2.1 | ) |
Sale and maturity of marketable investment securities | | | — | | | | — | | | | — | | | | 179.3 | | | | 5.8 | | | | — | | | | 185.1 | |
Purchase of intangible assets | | | — | | | | — | | | | (0.9 | ) | | | (141.3 | ) | | | (2.6 | ) | | | — | | | | (144.8 | ) |
Proceeds from disposal of intangible assets | | | — | | | | — | | | | — | | | | 0.5 | | | | — | | | | — | | | | 0.5 | |
Proceeds from business disposals | | | — | | | | — | | | | — | | | | 593.0 | | | | — | | | | — | | | | 593.0 | |
Purchase of product royalty rights | | | — | | | | — | | | | — | | | | (297.6 | ) | | | — | | | | — | | | | (297.6 | ) |
Net cash provided by/(used in) investing activities | | | — | | | | — | | | | (0.9 | ) | | | 368.0 | | | | 2.5 | | | | — | | | | 369.6 | |
Cash flows from financing activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Proceeds from sale of share capital | | | — | | | | — | | | | 167.9 | | | | — | | | | — | | | | — | | | | 167.9 | |
Payment under EPIL II guarantee | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | |
Repayment of loans | | | — | | | | — | | | | — | | | | (764.4 | ) | | | (6.3 | ) | | | — | | | | (770.7 | ) |
Net proceeds from debt issuance | | | — | | | | — | | | | — | | | | 443.9 | | | | — | | | | — | | | | 443.9 | |
Fee to EPIL II/III noteholders | | | — | | | | — | | | | (16.8 | ) | | | — | | | | — | | | | — | | | | (16.8 | ) |
Intercompany investments | | | — | | | | — | | | | (246.1 | ) | | | 721.1 | | | | (40.7 | ) | | | (434.3 | ) | | | — | |
Net cash provided by/(used in) financing activities | | | — | | | | — | | | | (95.0 | ) | | | 400.6 | | | | (47.0 | ) | | | (434.3 | ) | | | (175.7 | ) |
Effect of exchange rate changes on cash | | | — | | | | — | | | | — | | | | 12.5 | | | | — | | | | — | | | | 12.5 | |
Net increase/(decrease) in cash and cash equivalents | | | — | | | | — | | | | (161.1 | ) | | | (45.5 | ) | | | (15.2 | ) | | | (0.3 | ) | | | (222.1 | ) |
Cash and cash equivalents at beginning of year | | | — | | | | — | | | | 182.8 | | | | 782.4 | | | | 34.8 | | | | 0.3 | | | | 1,000.3 | |
Cash and cash equivalents at end of year | | $ | — | | | $ | — | | | $ | 21.7 | | | $ | 736.9 | | | $ | 19.6 | | | $ | — | | | $ | 778.2 | |
|
131
Elan Corporation, plc
Consolidating Statement of Cash Flows
For the Year Ended December 31, 2002
(in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Elan Finance, plc | | Athena Finance | | Parent Company | | Guarantor Subsidiaries | | Non- Guarantor Subsidiaries | | Elimination | | Consolidated |
Cash flows from operating activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss | | $ | — | | | $ | — | | | $ | (5,819.9 | ) | | $ | (1,125.9 | ) | | $ | (177.1 | ) | | $ | 4,764.7 | | | $ | (2,358.2 | ) |
Adjustments to reconcile net loss to | | | | | | | | | | | | | | | | | | | | | | | | | |
net cash provided by operating activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Amortization of deferred revenue | | | — | | | | — | | | | 96.7 | | | | 34.0 | | | | — | | | | (193.5 | ) | | | (62.8 | ) |
Amortization of financing costs | | | — | | | | — | | | | — | | | | 8.6 | | | | — | | | | 1.1 | | | | 9.7 | |
Depreciation and amortization | | | — | | | | — | | | | 19.6 | | | | 131.3 | | | | 8.5 | | | | 37.2 | | | | 196.6 | |
Loss on sale of investments | | | — | | | | — | | | | — | | | | 39.2 | | | | — | | | | — | | | | 39.2 | |
Impairment of investments | | | — | | | | — | | | | - | | | | 346.5 | | | | 322.1 | | | | 337.4 | | | | 1,006.0 | |
Provision for EPIL II guarantee | | | — | | | | — | | | | 295.4 | | | | — | | | | — | | | | — | | | | 295.4 | |
Disposals/write-down of other assets | | | — | | | | — | | | | 49.9 | | | | 31.9 | | | | 112.1 | | | | 466.3 | | | | 660.2 | |
Purchase of product royalty rights | | | — | | | | — | | | | — | | | | 121.0 | | | | — | | | | — | | | | 121.0 | |
(Gain)/loss on sale of business | | | — | | | | — | | | | — | | | | (177.9 | ) | | | — | | | | — | | | | (177.9 | ) |
Gain on repurchase of LYONs | | | — | | | | — | | | | — | | | | (37.7 | ) | | | — | | | | — | | | | (37.7 | ) |
Loss on sale of investments by EPIL III/Shelly Bay | | | — | | | | — | | | | — | | | | 141.6 | | | | — | | | | — | | | | 141.6 | |
Receipts from sale of product rights | | | — | | | | — | | | | — | | | | 2.5 | | | | — | | | | — | | | | 2.5 | |
Other | | | — | | | | — | | | | — | | | | 48.8 | | | | 6.5 | | | | 0.8 | | | | 56.1 | |
Net changes in assets and liabilities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Decrease in accounts receivables | | | — | | | | — | | | | 13.7 | | | | 116.7 | | | | 96.8 | | | | 15.0 | | | | 242.2 | |
Decrease/(increase) in intercompany receivables | | | — | | | | — | | | | 2,695.4 | | | | 921.9 | | | | 445.8 | | | | (4,063.1 | ) | | | — | |
Decrease/(increase) in prepaid and other assets | | | — | | | | — | | | | (1.2 | ) | | | (80.6 | ) | | | 18.0 | | | | 14.0 | | | | (49.8 | ) |
Decrease/(increase) in inventory | | | — | | | | — | | | | — | | | | (86.4 | ) | | | 60.9 | | | | 12.5 | | | | (13.0 | ) |
(Decrease)/increase in accounts payable and accruals | | | — | | | | — | | | | 5.7 | | | | 152.4 | | | | (119.1 | ) | | | 27.1 | | | | 66.1 | |
(Decrease)/increase in intercompany payables | | | — | | | | — | | | | 674.2 | | | | 299.1 | | | | (1,110.6 | ) | | | 137.3 | | | | — | |
(Decrease)/increase in other liabilities | | | | | | | — | | | | (1.9 | ) | | | 42.1 | | | | (7.7 | ) | | | (32.5 | ) | | | — | |
Net cash provided by/(used in) operating activities | | | — | | | | — | | | | (1,972.4 | ) | | | 929.1 | | | | (343.8 | ) | | | 1,524.3 | | | | 137.2 | |
Cash flows from investing activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Proceeds from disposal of property, plant and equipment | | | — | | | | — | | | | — | | | | 8.6 | | | | — | | | | — | | | | 8.6 | |
Purchase of property, plant and equipment | | | — | | | | — | | | | — | | | | (164.7 | ) | | | (5.5 | ) | | | — | | | | (170.2 | ) |
Purchase of investments | | | — | | | | — | | | | — | | | | (117.1 | ) | | | — | | | | — | | | | (117.1 | ) |
Proceeds from disposal of investments | | | — | | | | — | | | | — | | | | 10.4 | | | | — | | | | — | | | | 10.4 | |
Purchase of marketable investment securities | | | — | | | | — | | | | — | | | | (83.7 | ) | | | — | | | | — | | | | (83.7 | ) |
Sale and maturity of marketable investment securities | | | — | | | | — | | | | — | | | | 222.6 | | | | — | | | | — | | | | 222.6 | |
Purchase of intangible assets | | | — | | | | — | | | | — | | | | (315.5 | ) | | | — | | | | — | | | | (315.5 | ) |
Proceeds from disposal of intangible assets | | | — | | | | — | | | | — | | | | 9.4 | | | | — | | | | — | | | | 9.4 | |
Proceeds from business disposals | | | — | | | | — | | | | — | | | | 443.1 | | | | — | | | | — | | | | 443.1 | |
Purchase of product royalty rights | | | — | | | | — | | | | — | | | | (121.0 | ) | | | — | | | | — | | | | (121.0 | ) |
Redemption of investment in Autoimmune | | | — | | | | — | | | | — | | | | 38.5 | | | | — | | | | — | | | | 38.5 | |
Sale of EPIL III assets | | | — | | | | — | | | | — | | | | 9.3 | | | | — | | | | — | | | | 9.3 | |
Net cash provided by/(used in) investing activities | | | — | | | | — | | | | — | | | | (60.1 | ) | | | (5.5 | ) | | | — | | | | (65.6 | ) |
Cash flows from financing activities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Proceeds from sale of share capital | | | — | | | | — | | | | 5.7 | | | | — | | | | — | | | | — | | | | 5.7 | |
Repayment of EPIL III Notes | | | — | | | | — | | | | — | | | | — | | | | (160.0 | ) | | | — | | | | (160.0 | ) |
Repayment of loans | | | — | | | | — | | | | — | | | | (517.1 | ) | | | (10.5 | ) | | | — | | | | (527.6 | ) |
Shelly Bay bank loan | | | — | | | | — | | | | — | | | | 148.0 | | | | — | | | | — | | | | 148.0 | |
Repayment of Shelly Bay bank loan | | | — | | | | �� | | | | — | | | | (148.0 | ) | | | — | | | | — | | | | (148.0 | ) |
Intercompany investments | | | — | | | | — | | | | 2,026.9 | | | | (968.9 | ) | | | 375.8 | | | | (1,433.8 | ) | | | — | |
Net cash provided by/(used in) financing activities | | | — | | | | — | | | | 2,032.6 | | | | (1,486.0 | ) | | | 205.3 | | | | (1,433.8 | ) | | | (681.9 | ) |
Effect of exchange rate changes on cash | | | — | | | | — | | | | — | | | | 11.2 | | | | — | | | | — | | | | 11.2 | |
Net increase/(decrease) in cash and cash equivalents | | | — | | | | — | | | | 60.2 | | | | (605.8 | ) | | | (144.0 | ) | | | 90.5 | | | | (599.1 | ) |
Cash and cash equivalents at beginning of year | | | — | | | | — | | | | 122.6 | | | | 1,388.2 | | | | 178.8 | | | | (90.2 | ) | | | 1,599.4 | |
Cash and cash equivalents at end of year | | $ | — | | | $ | — | | | $ | 182.8 | | | $ | 782.4 | | | $ | 34.8 | | | $ | 0.3 | | | $ | 1,000.3 | |
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33. New Accounting Pronouncements Not Yet Adopted
In December 2004, the FASB issued Statement No. 123R, "Share-Based Payment – An Amendment of FASB Statements No. 123 and 95," ("SFAS No.123R"), which is effective for public companies in periods beginning after June 15, 2005. We will implement the proposed standard in the quarter beginning July 1, 2005. The cumulative effect of adoption, if any, applied on a modified prospective basis, will be measured and recognized on July 1, 2005. SFAS No. 123R addresses the accounting for transactions in which an enterprise receives goods and services in exchange for: (a) equity instruments of the enterprise; or (b) liabilities that are based on the fair value of the enterprise's equity instruments or that may be settled by the issuance of such equity instruments. SFAS No. 123R eliminates the ability to account for share-based compensation transactions using the intrinsic value method of APB 25, and generally would require instead that such transactions be accounted for using a fair-value based method. Equity classified awards are measured at grant date at fair value and are not subsequently re-measured. Liability classified awards are re-measured at fair value at each balance sheet date until the awards are settled. We are currently evaluating option valuation methodologies and assumptions in light of SFAS No. 123R related to employee stock options. Current estimates of option values using the Black-Scholes method (as reported) may not be indicative of results from valuation methodologies ultimately adopted.
In November 2004, the FASB issued Statement No. 151, "Inventory Costs: an amendment of ARB No. 43, Chapter 4" ("SFAS No. 151"), which is effective for public companies prospectively for inventory costs incurred in periods beginning after June 15, 2005. This Statement amends the guidance in ARB No. 43, Chapter 4, "Inventory Pricing," to clarify that accounting for abnormal amounts of idle facility expense, freight, handling costs and wasted material (spoilage) should be recognized as a current period charge and to require the allocation of fixed production overhead to the costs of conversion based on normal capacity of the production facilities. We do not expect that the adoption of SFAS No.151 will have a material impact on our financial position or results of operations.
In December 2004, the FASB issued Statement No. 153, "Exchanges of Nonmonetary assets – an amendment of APB Opinion No. 29," ("SFAS No. 153"), which is effective for public companies in periods beginning after June 15, 2005. The guidance in APB Opinion No. 29, Accounting for Nonmonetary Transactions, is based on the principle that exchanges of nonmonetary assets should be measured based on the fair value of the assets exchanged. The guidance in that Opinion, however, included certain exceptions to that principle. This Statement amends Opinion 29 to eliminate the exception for nonmonetary exchanges of similar productive assets and replaces it with a general exception for exchanges of nonmonetary assets that do not have commercial substance. A nonmonetary exchange has commercial substance if the future cash flows of the entity are expected to change significantly as a result of the exchange. We do not expect that the adoption of SFAS No. 153 will have a material impact on our financial position or results of operations.
In November 2003 and March 2004, the Emerging Issues Task Force ("EITF") reached partial consensus on EITF 03-1, "The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments," ("EITF 03-1"). EITF 03-1 addresses the meaning of other-than-temporary impairment and its application to investments classified as either available-for-sale or held-to-maturity under SFAS No. 115, and investments accounted for under the cost method. The EITF agreed on certain quantitative and qualitative disclosures about unrealized losses pertaining to securities classified as available-for-sale or held-to-maturity. In addition, EITF 03-1 requires certain disclosures about cost method investments. The recognition and measurement provisions of EITF 03-1 have been deferred until additional guidance is issued.
34. Post Balance Sheet Events
On February 28, 2005, we and Biogen Idec announced the voluntary suspension of the marketing and dosing in clinical trials of Tysabri. This decision was based on reports of two serious adverse events in patients treated with Tysabri in combination with Avonex in clinical trials. These events involved two cases of PML, a rare and frequently fatal demyelinating disease of the central nervous system. Both patients received more than two years of Tysabri therapy in combination with Avonex.
On March 30, 2005, we and Biogen Idec announced that our ongoing safety evaluation of Tysabri led to a previously diagnosed case of malignant astrocytoma being reassessed as PML, in a patient in an open label Crohn's disease clinical trial. The patient had received eight doses of Tysabri over an 18 month period. The patient died in December 2003.
We are working with leading experts, regulatory agencies and the clinical investigators to investigate these serious adverse events and to determine the appropriate path forward.
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Item 19. Exhibits.
| | | | | | |
EXHIBIT NUMBER | | DESCRIPTION |
1.1 | | Memorandum and Articles of Association of Elan Corporation, plc (incorporated by reference to Exhibit 3 of the Registration Statement on Form 8-A/A3 of Elan Corporation, plc (SEC File No. 001-13896) filed with the Commission on December 6, 2004). |
2(b)(1) | | Indenture, dated as of February 21, 2001, among Athena Neurosciences Finance, LLC, as Issuer, Elan Corporation, plc, as Guarantor, and The Bank of New York, as Trustee (incorporated by reference to Exhibit 4.11 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on February 21, 2001). |
2(b)(2) | | First Supplemental Indenture, dated as of February 21, 2001, among Athena Neurosciences Finance, LLC, as Issuer, Elan Corporation, plc, as Guarantor, and The Bank of New York, as Trustee (incorporated by reference to Exhibit 4.12 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on February 21, 2001). |
2(b)(3) | | Second Supplemental Indenture dated as of November 16, 2004 among Athena Neurosciences Finance, LLC, as Issuer, Elan Corporation, plc, as Guarantor, the Subsidiary Guarantors identified therein, as Subsidiary Guarantors, and The Bank of New York, as Trustee, to Indenture as supplemented by First Supplemental Indenture, each dated as of February 21, 2001, and each among Athena Neurosciences Finance, LLC, as Issuer, Elan Corporation, plc, as Guarantor, and The Bank of New York, as Trustee (incorporated by reference to Exhibit 99.1 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on November 19, 2004). |
2(b)(4) | | Form of Senior Note (incorporated by reference to Exhibit 4.13 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on February 21, 2001). |
2(b)(5) | | Indenture, dated as of November 10, 2003, by and among Elan Capital Corp., Ltd., Elan Corporation, plc and The Bank of New York, as Trustee (incorporated by reference to Exhibit 99.1 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on November 12, 2003). |
2(b)(6) | | Indenture dated as of November 16, 2004, among Elan Finance public limited company, Elan Finance Corp., Elan Corporation, plc, the Subsidiary Note Guarantors party thereto and The Bank of New York, as Trustee (incorporated by reference to Exhibit 99.2 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc filed with the Commission on November 19, 2004). |
4(a)(1) | | Antegren Development and Marketing Collaboration Agreement, dated as of August 15, 2000, by and between Biogen, Inc. and Elan Pharma International Limited (incorporated by reference to Exhibit 4(a)(1) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2002). |
4(a)(2) | | Amended and Restated Asset Purchase Agreement, dated as of May 19, 2003, by and among Elan Corporation, plc, Elan Pharma International Limited, Elan Pharmaceuticals, Inc., King Pharmaceuticals, Inc., Jones Pharma Incorporated and Monarch Pharmaceuticals, Inc. (incorporated by reference to Exhibit 4(a)(3) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2002). |
4(c)(1) | | Elan Corporation, plc 1999 Stock Option Plan (2001 Amendment) (incorporated by reference to Exhibit 4(c)(1) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2001). |
4(c)(2) | | Elan Corporation, plc 1998 Long-Term Incentive Plan (2001 Restatement) (incorporated by reference to Exhibit 4(c)(2) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2001). |
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| | | | | | |
EXHIBIT NUMBER | | DESCRIPTION |
4(c)(3) | | Elan Corporation, plc 1996 Long-Term Incentive Plan (2001 Restatement) (incorporated by reference o Exhibit 4(c)(3) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2001). |
4(c)(4) | | Elan Corporation, plc 1996 Consultant Option Plan (2001 Restatement) (incorporated by reference to Exhibit 4(c)(4) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2001). |
4(c)(5) | | Elan Corporation, plc Employee Equity Purchase Plan (U.S.). |
4(c)(6) | | Elan Corporation, plc Employee Equity Purchase Plan Irish Sharesave Option Scheme. |
4(c)(7) | | Elan Corporation, plc Employee Equity Purchase Plan U.K. Sharesave Plan. |
4(c)(8) | | Elan U.S. Severance Plan |
4(c)(9) | | Consulting Agreement, dated as of July 1, 1986, between Dr. Dennis J. Selkoe and Athena Neurosciences, Inc. (incorporated by reference to Exhibit 4(c)(5) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2002). |
4(c)(10) | | Letter Agreement, dated as of February 12, 2002, between John Groom and Elan Corporation, plc (incorporated by reference to Exhibit 10.1 of the Registration Statement on Form F-3 of Elan Corporation, plc, Registration Statement No. 333-100252, filed with the Commission on October 1, 2002). |
4(c)(11) | | Consulting Agreement, dated as of April 1, 2002, between Dr. Dennis J. Selkoe and Elan Pharmaceuticals, Inc. (incorporated by reference to Exhibit 4(c)(7) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2002). |
4(c)(12) | | Employment Agreement, dated as of January 7, 2003, among Elan Pharmaceuticals, Inc., Elan Corporation, plc and G. Kelly Martin, (incorporated by reference to the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on February 4, 2003). |
8.1 | | Subsidiaries of Elan Corporation, plc. |
10.1 | | Report of Independent Registered Public Accounting Firm, KPMG |
10.2 | | Consent of Independent Registered Public Accounting Firm, KPMG |
12.1 | | Certification of G. Kelly Martin pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
12.2 | | Certification of Shane Cooke pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
13.1 | | Certification of G. Kelly Martin pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
13.2 | | Certification of Shane Cooke pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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SIGNATURES
Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and has duly caused the undersigned to sign this annual report on our behalf by the undersigned thereunto duly authorized.
| Elan Corporation, plc |
| | | | | | |
Date: April 8, 2005 | | /s/ SHANE COOKE |
| | Executive Vice President and Chief Financial Officer |
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136
Elan Corporation, plc
Schedule II
Valuation and Qualifying Accounts and Reserves
Years ended December 31, 2004, 2003 and 2002
(in millions)
| | | | | | | | | | | | | | | | | | |
Description | | Balance at Beginning of Year | | Additions | | Deductions(1) | | Balance at End of Year |
Allowance for doubtful accounts (2): | | | | | | | | | | | | | | | | |
Years ended December 31, 2004 | | $ | 11.6 | | | $ | 1.7 | | | $ | (7.8 | ) | | $ | 5.5 | |
Years ended December 31, 2003 | | $ | 23.1 | | | $ | 7.5 | | | $ | (19.0 | ) | | $ | 11.6 | |
Years ended December 31, 2002 | | $ | 15.0 | | | $ | 20.8 | | | $ | (12.7 | ) | | $ | 23.1 | |
| | | | | | | | | | | | | | | | |
Sales returns and allowances, discounts, chargebacks and rebates (3): | | | | | | | | |
Years ended December 31, 2004 | | $ | 81.4 | | | $ | 48.7 | | | $ | (107.5 | ) | | $ | 22.6 | |
Years ended December 31, 2003 | | $ | 129.2 | | | $ | 146.8 | | | $ | (194.6 | ) | | $ | 81.4 | |
Years ended December 31, 2002 | | $ | 66.4 | | | $ | 269.4 | | | $ | (206.6 | ) | | $ | 129.2 | |
|
| |
(1) | Represents amounts written off or returned against the allowance or reserves, or returned against earnings. |
| |
(2) | Additions to allowance for doubtful accounts are recorded as an expense. |
| |
(3) | Additions to sales returns and allowances, discounts, chargebacks and rebates are recorded as a reduction of revenue. |
EXHIBIT INDEX
| | | | | | |
EXHIBIT NUMBER | | DESCRIPTION |
1.1 | | Memorandum and Articles of Association of Elan Corporation, plc (incorporated by reference to Exhibit 3 of the Registration Statement on Form 8-A/A3 of Elan Corporation, plc (SEC File No. 001-13896) filed with the Commission on December 6, 2004). |
2(b)(1) | | Indenture, dated as of February 21, 2001, among Athena Neurosciences Finance, LLC, as Issuer, Elan Corporation, plc, as Guarantor, and The Bank of New York, as Trustee (incorporated by reference to Exhibit 4.11 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on February 21, 2001). |
2(b)(2) | | First Supplemental Indenture, dated as of February 21, 2001, among Athena Neurosciences Finance, LLC, as Issuer, Elan Corporation, plc, as Guarantor, and The Bank of New York, as Trustee (incorporated by reference to Exhibit 4.12 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on February 21, 2001). |
2(b)(3) | | Second Supplemental Indenture dated as of November 16, 2004 among Athena Neurosciences Finance, LLC, as Issuer, Elan Corporation, plc, as Guarantor, the Subsidiary Guarantors identified therein, as Subsidiary Guarantors, and The Bank of New York, as Trustee, to Indenture as supplemented by First Supplemental Indenture, each dated as of February 21, 2001, and each among Athena Neurosciences Finance, LLC, as Issuer, Elan Corporation, plc, as Guarantor, and The Bank of New York, as Trustee (incorporated by reference to Exhibit 99.1 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on November 19, 2004). |
2(b)(4) | | Form of Senior Note (incorporated by reference to Exhibit 4.13 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on February 21, 2001). |
2(b)(5) | | Indenture, dated as of November 10, 2003, by and among Elan Capital Corp., Ltd., Elan Corporation, plc and The Bank of New York, as Trustee (incorporated by reference to Exhibit 99.1 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on November 12, 2003). |
2(b)(6) | | Indenture dated as of November 16, 2004, among Elan Finance public limited company, Elan Finance Corp., Elan Corporation, plc, the Subsidiary Note Guarantors party thereto and The Bank of New York, as Trustee (incorporated by reference to Exhibit 99.2 of the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc filed with the Commission on November 19, 2004). |
4(a)(1) | | Antegren Development and Marketing Collaboration Agreement, dated as of August 15, 2000, by and between Biogen, Inc. and Elan Pharma International Limited (incorporated by reference to Exhibit 4(a)(1) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2002). |
4(a)(2) | | Amended and Restated Asset Purchase Agreement, dated as of May 19, 2003, by and among Elan Corporation, plc, Elan Pharma International Limited, Elan Pharmaceuticals, Inc., King Pharmaceuticals, Inc., Jones Pharma Incorporated and Monarch Pharmaceuticals, Inc. (incorporated by reference to Exhibit 4(a)(3) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2002). |
4(c)(1) | | Elan Corporation, plc 1999 Stock Option Plan (2001 Amendment) (incorporated by reference to Exhibit 4(c)(1) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2001). |
4(c)(2) | | Elan Corporation, plc 1998 Long-Term Incentive Plan (2001 Restatement) (incorporated by reference to Exhibit 4(c)(2) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2001). |
|
| | | | | | |
EXHIBIT NUMBER | | DESCRIPTION |
4(c)(3) | | Elan Corporation, plc 1996 Long-Term Incentive Plan (2001 Restatement) (incorporated by reference o Exhibit 4(c)(3) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2001). |
4(c)(4) | | Elan Corporation, plc 1996 Consultant Option Plan (2001 Restatement) (incorporated by reference to Exhibit 4(c)(4) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2001). |
4(c)(5) | | Elan Corporation, plc Employee Equity Purchase Plan (U.S.). |
4(c)(6) | | Elan Corporation, plc Employee Equity Purchase Plan Irish Sharesave Option Scheme. |
4(c)(7) | | Elan Corporation, plc Employee Equity Purchase Plan U.K. Sharesave Plan. |
4(c)(8) | | Elan U.S. Severance Plan |
4(c)(9) | | Consulting Agreement, dated as of July 1, 1986, between Dr. Dennis J. Selkoe and Athena Neurosciences, Inc. (incorporated by reference to Exhibit 4(c)(5) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2002). |
4(c)(10) | | Letter Agreement, dated as of February 12, 2002, between John Groom and Elan Corporation, plc (incorporated by reference to Exhibit 10.1 of the Registration Statement on Form F-3 of Elan Corporation, plc, Registration Statement No. 333-100252, filed with the Commission on October 1, 2002). |
4(c)(11) | | Consulting Agreement, dated as of April 1, 2002, between Dr. Dennis J. Selkoe and Elan Pharmaceuticals, Inc. (incorporated by reference to Exhibit 4(c)(7) of Elan Corporation, plc's Annual Report on Form 20-F for the fiscal year ended December 31, 2002). |
4(c)(12) | | Employment Agreement, dated as of January 7, 2003, among Elan Pharmaceuticals, Inc., Elan Corporation, plc and G. Kelly Martin, (incorporated by reference to the Report of Foreign Issuer on Form 6-K of Elan Corporation, plc, filed with the Commission on February 4, 2003). |
8.1 | | Subsidiaries of Elan Corporation, plc. |
10.1 | | Report of Independent Registered Public Accounting Firm, KPMG |
10.2 | | Consent of Independent Registered Public Accounting Firm, KPMG |
12.1 | | Certification of G. Kelly Martin pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
12.2 | | Certification of Shane Cooke pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
13.1 | | Certification of G. Kelly Martin pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
13.2 | | Certification of Shane Cooke pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|