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SHIRE PHARMACEUTICALS GROUP PLC (Exact Name of Registrant As Specified in Its Charter)

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SHIRE PHARMACEUTICALS GROUP PLC (Exact Name of Registrant As Specified in Its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2003 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 0-29630 SHIRE PHARMACEUTICALS GROUP PLC (Exact name of registrant as specified in its charter) England and Wales 98-0359573 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Hampshire International Business Park, Chineham, +44 1256 894 000 Basingstoke, Hampshire, England, RG24 8EP (Registrant’s telephone number, including area code) (Address of principal executive offices and zip code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of exchange on which registered American Depositary Shares, each representing 3 NASDAQ National Market Ordinary Shares 5 pence par value per share Securities registered pursuant to Section 12(g) of the Act: None (Title of class) Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant’s knowledge, in definitive proxy or information statements incorporated by reference to Part III of this Form 10-K or any amendment to this Form 10-K. [X] Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Act). Yes [X] No [ ] 1 As of June 30, 2003, the last business day of the Registrant’s most recently completed second quarter, the aggregate market value of the ordinary shares, £0.05 par value per share of the Registrant held by non-affiliates was approximately $3,203 million. This was computed using the average bid and asked price at the above date. As of March 1, 2004, the number of outstanding ordinary shares of the Registrant was 478,922,099. THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included herein that are not historical facts, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact on Shire’s Attention Deficit Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire’s ADHD franchise, government regulation and approval, including but not limited to the expected product approval dates of lanthanum carbonate (FOSRENOL®), METHYPATCH®, XAGRID® and the adult indication for ADDERALL XR®, the implementation of the planned reorganization and other risks and uncertainties detailed from time to time in Shire’s filings, including this Annual Report filed on Form 10-K, for the year ended December 31, 2003 by Shire, with the Securities and Exchange Commission. The following are trademarks, either owned or licensed by Shire or companies within the Shire Group, which are the subject of trademark registrations in certain territories. ADDERALL XR® (mixed amphetamine salts) ADDERALL® (mixed amphetamine salts) AGRYLIN® (anagrelide hydrochloride) ALERTEC® (modafinil) AMATINE® (midodrine hydrochloride) CALCICHEW® (calcium carbonate) CARBATROL® (carbamazepine) COLAZIDE® (basalazide) ETHMOZINE® (moracizine hydrochloride) FOSRENOL® (lanthanum carbonate) FLUVIRAL® S/F (split virion influenza vaccine) INDURGAN® (omeprazole) METHYPATCH® (methylphenidate) PERMAX® (pergolide mesylate) PROAMATINE® (midodrine hydrochloride) SOLARAZE® (diclofenac sodium 3%) TROXATYL® (troxacitabine) XAGRID® (anagrelide hydrochloride) VANIQA® (eflornithine hydrochloride) The following are trademarks of third parties. 3TC (trademark of GlaxoSmithKline (GSK)) ADEPT (trademark of ML Laboratories) COMBIVIR (trademark of GSK) EPIVIR (trademark of GSK) EPIVIR-HBV (trademark of GSK) FARESTON (trademark of Orion) HEPTOVIR (trademark of GSK) PENTASA (trademark of Ferring AS) REMINYL (trademark of Johnson & Johnson) TRIZIVIR (trademark of GSK) ZEFFIX (trademark of GSK) 2 SHIRE PHARMACEUTICALS GROUP PLC 2003 Form 10-K Annual Report Table of contents PART I ITEM 1. BUSINESS General 4 Recent developments 4 Financial information about operating segments 5 Strategy 5 Sales and marketing 5 Principal licensing and collaborative agreements 16 Manufacturing and distribution 18 Intellectual property 18 Competition 19 Government regulation 20 Third party reimbursement 22 Corporate social responsibility 22 Employees 22 Risk factors 22 Available information 28 ITEM 2. PROPERTIES 29 ITEM 3. LEGAL PROCEEDINGS 30 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS 31 PART II ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS 32 ITEM 6. SELECTED FINANCIAL DATA 34 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 36 ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 57 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 57 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 57 ITEM 9A. CONTROLS AND PROCEDURES 58 PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT 59 ITEM 11. EXECUTIVE COMPENSATION 62 ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 66 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS 67 ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 68 PART IV ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K 69 3 PART I ITEM 1: Business General Shire Pharmaceuticals Group plc and its subsidiaries (collectively referred to as Shire, the Company or the Group) is a global pharmaceutical company with a strategic focus on meeting the needs of the specialist physician. The Company has a particular interest in innovative therapies that are prescribed by specialist doctors as opposed to primary care physicians. Shire was incorporated under the laws of England and Wales on January 1, 1994 and is a public limited company. In May 2001, Shire merged with BioChem Pharma, Inc. (BioChem), an international pharmaceutical company based in Laval, Canada. This brought anti-infective projects to Shire as well as a royalty stream on sales of 3TC and ZEFFIX, out-licensed to GlaxoSmithKline (GSK). In September 2002, Shire acquired Atlantic Pharmaceutical Services Inc. (APS), subsequently renamed Shire US Manufacturing Inc. (SUMI), which includes a state-of-the-art manufacturing facility located in Owings Mills, Maryland. It is expected that the SUMI facility will become a primary or secondary manufacturer for ADDERALL XR, CARBATROL, PENTASA and DEXTROSTAT in 2004. This will mitigate Shire’s supply risk in the US, in line with the Company’s policy of dual sourcing key products. In February 2003, the Company acquired the worldwide sales and marketing rights to METHYPATCH, a methylphenidate transdermal delivery system for the once-daily treatment of attention deficit hyperactivity disorder (ADHD) from Noven Pharmaceuticals Inc. Also during 2003, the Company acquired five products for the Canadian market from DRAXIS Health Inc. and certain international rights to VANIQA from Women First Healthcare, Inc. Recent developments As a result of Shire’s rapid growth, a complex operational structure was created. In order to better integrate, coordinate and rationalize our business activities, Shire has embarked on a wide reaching strategic change program. The aim is to move the Company from a silo structure to a globally integrated organization composed of cross-functional teams with clear accountability for delivering results. The business will also be serviced by support functions that will be global in their outlook. The management model has been changed to accomplish this. The introduction of Portfolio Teams and the housing of research and development (R&D) and US commercial functions under one roof will improve communication and focus, and speed up the process of making decisions. The US is the world’s largest pharmaceuticals market, where the Company already generates 68% of its revenues and where more than 50% of employees are based. In recognition of this the Company will establish a new corporate office on the East Coast; Pennsylvania is being considered in this regard. In addition to the vaccine sites in Canada and the US that will be exited, the Company will close its Newport, Kentucky and Rockville, Maryland sites. The Company foresees having just four major North American facilities by the end of 2005 compared with fourteen at the beginning of 2003. The International division will continue to be led from the UK and appropriate R&D presence will also be maintained in Basingstoke to serve the European markets. The cost of the change program in 2004 is estimated at approximately $55 million, split
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