-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, EEuwBwSWl1+W5/KBY65E9vVnAsbVOBgcqqag6hrV6YO5hGWf09MzbUHdQ58xKH7J aev9t/LpR0KPXc+p6LgNrg== 0000950162-03-000641.txt : 20030331 0000950162-03-000641.hdr.sgml : 20030331 20030331152941 ACCESSION NUMBER: 0000950162-03-000641 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 9 CONFORMED PERIOD OF REPORT: 20021231 FILED AS OF DATE: 20030331 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SHIRE PHARMACEUTICALS GROUP PLC CENTRAL INDEX KEY: 0000936402 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29630 FILM NUMBER: 03630175 BUSINESS ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 BUSINESS PHONE: 1264333455 MAIL ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 10-K 1 shire10k033103.txt UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2002 [ ] 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, Basingstoke, RG24 8EP - -------------------------------------------------------------- -------- Hampshire, England (Zip Code) ------------------- (Address of principal executive offices) 44 1256 894 000 --------------- (Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b)of the Act: Title of each class Name of exchange on which registered American Depository Shares, each representing 3 Common Shares NASDAQ National Market - -------------------------------------------------------------- ---------------------- 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 [ ] 1 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. [ ] Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Act). Yes [X], No [ ]. As of June 30, 2002, the aggregate market value of the common shares, (pound)0.05 par value per share of the Registrant held by non-affiliates was approximately $4,153 million. This was computed using the average bid and ask price at the above date. As of March 24, 2003, the number of outstanding common shares of the Registrant was 484,523,040. 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 that 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 approval date of lanthanum carbonate (FOSRENOL(R)) and METHYPATCH(R), and other risks and uncertainties detailed from time to time in our filings with the Securities and Exchange Commission including this annual report on Form 10-K for the year ended December 31, 2002. 2 PART I ITEM 1: Business (a) General development of the business Shire is an emerging global pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, gastro intestinal, oncology, and anti-infectives. Our strategy is further supported by three platform technologies: advanced drug delivery, lead optimization for small molecules, and biologics. We have sales and marketing subsidiaries with a portfolio of products targeting the U.S., Canada, the U.K., the Republic of Ireland, France, Germany, Italy and Spain. We also cover other significant pharmaceutical markets indirectly through distributors. We operate and manage our business within three individual operating segments: U.S., International, and Global Research and Development. Within these segments, revenues are derived primarily from three sources: sales of products by our own sales and marketing operations, royalties where we have out-licensed product rights to third parties, and licensing and development fees. We were incorporated under the laws of England and Wales on January 1, 1994 and are now a public limited company under the same laws. As part of a recapitalization, we acquired the entire share capital of Shire Holdings Limited on December 19, 1994, including the operations of Rybar Laboratories Limited, a U.K. based sales and marketing company acquired by our predecessor in July 1992. In September 1995, we acquired Imperial Pharmaceutical Services Limited (subsequently renamed Shire Pharmaceutical Contracts Limited). We acquired Pharmavene, Inc. (subsequently renamed Shire Laboratories, Inc.) in March 1997 and Richwood Pharmaceutical Company, Inc. (subsequently renamed Shire Richwood, Inc. and then Shire US Inc.) in August 1997. In October 1999, we acquired the German, French and Italian sales and marketing subsidiaries of Fuisz Technologies Limited (the subsidiaries were subsequently renamed Shire Deutschland GmbH, Shire France SA and Shire Italia SpA respectively). We merged with Roberts Pharmaceutical Corporation (Roberts) in December 1999. Following the merger, the U.S. sales and marketing operations of Roberts were merged with Shire Richwood, Inc. In May 2000, we established a representative office in Singapore to effectively manage our activities in the Pacific Rim markets. In June 2000, we established a sales and marketing subsidiary in Spain, Shire Pharma Iberica SL. In 2002, we established Shire Pharmaceuticals Ireland Limited. In May 2001, Shire merged with BioChem Pharma, Inc. (BioChem), an international specialty pharmaceutical company based in Laval, Canada, which provided two major development capabilities in lead optimization and biologics. This brought an anti-infective pipeline to Shire, as well as the royalty stream on sales of 3TC and ZEFFIX, by GlaxoSmithKline (GSK). In addition, it further strengthened our know-how and expertise in oncology. We have expanded our business both organically and through acquisitions. In February 2003, we agreed to acquire, from Noven Pharmaceuticals Inc., the worldwide sales and marketing rights to METHYPATCH, a methylphenidate transdermal delivery system for the once-daily treatment of ADHD. In addition, we acquired a pharmaceutical manufacturing facility, Atlantic Pharmaceutical Services Inc. (APS) (subsequently renamed Shire US Manufacturing Inc.), from Niro Inc. in September 2002. The APS facility will become one of the principal manufacturing sites for Shire US operations and will support the strategy of dual sourcing for key products. Our principal executive offices are located at Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, England and our telephone number is + 44 1256 894000. In this report, the term "Shire" refers to Shire Pharmaceuticals Group plc and the term "the Company" refers to Shire Pharmaceuticals Group plc and its subsidiaries, unless the context indicates otherwise. (b) Financial information about operating segments Substantially, all of our revenues, operating profits or losses and assets are attributable to the acquisition, research and development, manufacture, sale and distribution of pharmaceutical products within three individual operating segments: U.S., International, and Global Research and Development. 3 (c) Description of the business (i) Strategy and approach Whilst the balance of revenue and profit growth has been towards the U.S., during the last two years we have continued to develop our global strategy by launching two new specialty pharmaceutical products, SOLARAZE(R) (diclofenac sodium 3%) and ADEPT(R) (4% icodrextrin), in European countries, including the U.K., Spain, Italy, France, Germany and the Republic of Ireland. These two new products have already contributed to our International segment, which has delivered total sales growth of 29% in 2002. Shire has a risk-balanced research and development portfolio with a clear focus on future product needs. To enhance the potential for future growth, we follow two main approaches; firstly, to start projects in-house through research and advanced drug delivery and secondly to in-license projects and products on reasonable commercial terms, and then to develop and launch them. This broad approach strengthens our strategy. We remain an acquisitive company. In the past eight years we have completed six major mergers and acquisitions, each one providing or building on our internal platforms for growth. We will continue to evaluate companies, products and project opportunities that offer a good strategic fit and provide additional shareholder value. Our business model has five levels of focus: functional, customer, therapeutic, geographic and technology. o Functional focus We focus on specific functional areas of the business that are identified as being key drivers for success, such as research and development and sales and marketing. Our current R&D pipeline of projects includes 13 that are either in or post Phase II development. In order to reduce financial and business risk, we maintain a careful and objective discipline in our approach to R&D risk management by weighting our portfolio of projects towards those projects viewed as low to medium risk. Part of this strategy is the acquisition of projects at a given stage of development, as such in-licensing opportunities typically reduce our exposure to the high risks associated with the early stages of research and development. We believe that, as a consequence, the average risk profile of projects in our R&D portfolio is targeted to be lower than the industry average. Our sales and marketing function is another essential factor contributing to our success. We take pride in our well-trained and highly-motivated sales forces that have, through the success of our key marketed products and successful introduction of ADDERALL XR(R) (mixed amphetamine salts) and conversion of patients from ADDERALL(R) (mixed amphetamine salts), demonstrated outstanding professionalism and performance. We continue to outsource non-core activities in order to keep the Company dynamic and efficient. o Customer focus We have a particular interest in innovative therapies that are prescribed by specialist doctors, as opposed to those prescribed by primary care or general practitioners. We target specialist doctors because they usually lead innovations in prescribing. They are smaller in number and easier to target effectively for a company of our size. o Therapeutic focus Our main areas of therapeutic focus are: central nervous system disorders, gastro intestinal, oncology, and anti-infectives, supported by three platform technologies: advanced drug delivery, lead optimization for small molecules, and biologics. In December 2002, we completed the sale of our U.S. `Over-The-Counter' (OTC) products to Purdue Pharmaceuticals Inc. This divestment represents our complete exit from OTC operations in the US and will allow us to focus resources on our core strategy of providing prescription pharmaceuticals to specialist doctors. 4 o Geographic focus We currently market our products using our own sales forces in seven of the eight major pharmaceutical markets of the world. We also cover other significant pharmaceutical markets indirectly through distributors. In addition, one of our strategic goals is to establish a presence in Japan in the future. o Technology focus Our three platform technologies, advanced drug delivery, lead optimization for small molecules and biologics, are an important part of our risk-balanced approach. We seek to obtain patent protection through our advanced drug delivery expertise wherever possible. Importantly, these three platform technologies also widen our ability to in-license research programs, development projects and products. We can use these technologies either to develop them internally or to manage the life-cycle of existing products. Our strategy includes the identification of off patent products that could be enhanced using the technologies of our oral drug delivery company, Shire Laboratories Inc., based in Maryland, U.S. Examples of such projects are ADDERALL XR and CARBATROL(R) (carbamazepine). (ii) Sales and marketing Our sales and marketing operations in the U.S., the U.K., the Republic of Ireland, the key countries of continental Europe and Canada presently consist of 603 sales representatives. We believe that our sales and marketing infrastructure can be expanded rapidly to meet product opportunities. Currently marketed products The table below lists our key currently marketed products by therapeutic area, indicating the owner or licensor of the product, the marketer of the product and the territory in which the product is being marketed.
Products Principal indication(s) Owner/licensor Marketed by/relevant territory - --------- -------------------- -------------- ---------------------------- Treatments for central nervous system disorders Adderall XR(R) ADHD Shire Shire - U.S. Adderall(R) ADHD Shire Shire - U.S. Carbatrol(R) Epilepsy Shire Shire - U.S. REMINYL(R)(galantamine Alzheimer's disease Synaptech Inc. Shire and Janssen - U.K. & Republic of hydrobromide) Ireland Janssen - RoW Treatments for gastro intestinal diseases Pentasa(R) Ulcerative colitis Ferring Shire - U.S. (mesalamine) Oncology treatments Agrylin(R)(anagrelide) Essential thrombocythemia Shire Shire - U.S. and Canada
5
Products Principal indication(s) Owner/licensor Marketed by/relevant territory - --------- -------------------- -------------- ---------------------------- Treatments for infections 3TC*/EPIVIR* HIV/AIDS Shire** Shire & GSK - Canada, GSK - RoW COMBIVIR* HIV/AIDS Shire** Shire & GSK - Canada, GSK - RoW TRIZIVIR* HIV/AIDS Shire** Shire & GSK - Canada, GSK - RoW ZEFFIX*/EPIVIR HBV*/ HEPTOVIR*1 Hepatitis B infection Shire** Shire & GSK - Canada, GSK - RoW Treatments for other diseases ProAmatine(R)/ Orthostatic hypotension Nycomed Shire - U.S. and Canada (midodrine hydrochloride) Amatine(R) CALCICHEW(R)(calcium carbonate) range Adjunct in osteoporosis Nycomed Shire - U.K. and Republic of Ireland2
1 This is not a comprehensive list of trademarks for this product as various others are used in smaller markets. 2 Also distributed in various export markets on our behalf. (R) Our trademarks or those of our subsidiaries. * Trademarks of GSK. ** GSK is the owner / licensor of some rights in these products. Treatments for central nervous system disorders Adderall XR and AdderalL Attention Deficit Hyperactivity Disorder (ADHD) is a central nervous system disorder, characterized by varying degrees of inattention, impulsivity and hyperactivity. It was originally thought to be a childhood disorder only, but has now been fully recognized as a disorder in adults as well. According to IMS America, the U.S. market for ADHD treatments was approximately $1.5 billion for the year ended December 31, 2002. It is estimated that between 3% and 7% of children in the U.S. suffer from the condition. Our products, ADDERALL XR and ADDERALL, contain a combination of four amphetamine salts. ADDERALL was launched in 1996 and was the ADHD brand leader at the end of 2001. Adderall XR is a patented formulation of Adderall that uses Shire Laboratories' Microtrol(R) drug delivery technology and is designed to provide an all day treatment with one morning dose. It can be administered as a capsule or sprinkled on soft food. In the ADHD market, a once a day formulation is accepted to be an important benefit as it: o provides all day control of symptoms, o avoids the need for medication to be taken at school, o reduces the risk of diversion, o allows parental control of medication, o offers potential for improved compliance, o decreases social stigma, and o eases the burden on school nurses. ADDERALL XR was approved by the U.S. Food and Drug Administration (FDA) on October 12, 2001. In November 2001 a formulation and pharmaceutical composition patent relating to ADDERALL XR was issued by the U.S. Patent and Trademark Office, expiring in 2018. The product was launched by promotion to doctors on November 5, 2001, and according to IMS Health had already achieved a 23.7% share of the U.S. prescription ADHD market for the week ending December 27, 2002. Sales of ADDERALL XR and ADDERALL during 2002 were $427.7 million, representing approximately 41% of our total revenues. As a result, factors adversely affecting the sale or production of ADDERALL XR and ADDERALL would have a material adverse effect on our financial condition and results of operation. 6 On February 11, 2002 Barr Laboratories Inc. (Barr) announced FDA approval to market a generic version of the original ADDERALL formulation which is not patent protected. Since then, several other companies have also obtained approval and launched generic versions of ADDERALL. In November 2002 we received approval from the FDA for a new formulation of ADDERALL which is patent protected. In January 2003 we received a Paragraph IV notice from Barr alleging that this patent is invalid and not infringed by Barr's 7.5 mg, 12.5 mg and 15 mg mixed amphetamine salt products. Further details are included in the intellectual property section below. Our extended release product ADDERALL XR is covered by a US patent . In January 2003 we received a Paragraph IV notice from Barr alleging that this patent is invalid and not infringed by Barr's extended release mixed amphetamine salt product, the subject of a pending Barr Abbreviated New Drug Application (ANDA). In February 2003, Shire Laboratories Inc. filed suit against Barr for infringement of this U.S. patent. For more details see sections headed intellectual property and legal proceedings below . There can be no assurance that the Company will prevail in the suit and in the event it does not this may have a material adverse impact on the Company's results and financial position . A Supplemental New Drug Application (sNDA) filing was made in December 2002 for use of ADDERALL XR in adults. Two new life cycle management projects for the ADDERALL franchise are currently under development (SPD465 and SPD483). Carbatrol Approximately 2.3 million people in the U.S. suffer from epilepsy, a disorder that is characterized by an episodic disturbance of consciousness during which seizure activity occurs in the brain. Carbatrol is an extended release formulation of carbamazepine that uses Shire Laboratories' Microtrol technology. It can be administered as a capsule or sprinkled on food and delivers consistent blood levels of drug over 24 hours, when taken twice daily. When administered in an immediate release formulation, carbamazepine requires dosing three to four times a day. CARBATROL therefore provides advantages for patients, aiding compliance. Carbamazepine is one of the most widely prescribed antiepileptic drugs, accounting for approximately 10% of total U.S. anti-epileptic prescriptions written in 2002. Prescription numbers for Carbatrol increased from 853,000 in 2001 to 909,000 in 2002. In 1994, we obtained a patent in the U.S. covering the formulation of Carbatrol with an expiration date of 2011. The FDA approved CARBATROL on September 30, 1997 for marketing in the U.S. The product was originally out-licensed to Athena Inc., a subsidiary of Elan Corporation plc. In December 1997, we re-acquired the worldwide rights to Carbatrol, together with inventory, certain plants and equipment for $25.0 million. We launched Carbatrol in the U.S. in June 1998. On March 31, 1999, we terminated our promotion agreement with Athena. Patent applications covering this technology are pending in other countries. We announced on November 6, 2002, that with enhanced supply capability, including the recent acquisition of APS, we planned to re-launch CARBATROL in the U.S. market early in 2003. In the year ended December 31, 2002, sales of CARBATROL were $45.3 million, representing approximately 4% of our total revenues. REMINYL Alzheimer's disease is characterized by loss of memory, particularly of recent events, confusion and disorientation, followed by severe intellectual disturbances, personality changes and emotional disintegration. It is progressive, with death usually occurring within five to nine years following the onset of symptoms. It is estimated that approximately 4 million people in the U.S. suffer from Alzheimer's disease. It is estimated that one in four people over the age of 75 suffers with the disease. REMINYL, a treatment for mild to moderate Alzheimer's disease, was developed with Janssen Research Foundation under a co-development and licensing agreement. The first regulatory approval within the European Union (EU) for REMINYL was received from Sweden on March 3, 2000. In July 2000, REMINYL successfully completed the EU Mutual Recognition Procedure and was launched in the U.K. in September 2000. This was followed by launches in a number of other countries during late 2000 and 2001. 7 In the U.S., REMINYL was approved by the FDA on February 28, 2001 and launched in May 2001 by Janssen Pharmaceutical and Ortho-McNeil Pharmaceutical. The European Summary of Product Characteristics indicates that REMINYL has a novel dual mechanism of action. Decreased levels of acetylcholine, caused by the death of acetylcholine neurons, are known to be related to the symptoms of Alzheimer's disease. In addition to preserving levels of acetylcholine in the brain by blocking the action of the enzyme acetylcholinesterase, which inactivates acetylcholine, laboratory research suggests that REMINYL may also act on the brain's nicotinic receptors. The modulation of these receptors may lead to the release of more acetylcholine. Janssen Research Foundation is investigating the clinical significance of this characteristic. REMINYL was launched using natural galantamine extracted from daffodil bulbs. Regulatory approval for the synthetic manufacture of galantamine was gained in 2001 in Europe and the U.S. We will be relying on Janssen and Waldheim Pharmaceutica for the supply of synthetic galantamine of suitable quality and quantity, but there can be no assurance that adequate supplies will be available. Janssen are also developing REMINYL for additional indications including vascular and mixed dementias. Treatments for gastro intestinal diseases PENTASA Ulcerative colitis, a component of inflammatory bowel disease, is a chronic, relapsing disease in which part or all of the large intestine becomes inflamed and often ulcerated. The mainstay of treatment for inflammatory bowel disease is 5-aminosalicylate-based (mesalamine) products. PENTASA controlled-release capsules are indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis. PENTASA is an ethylcellulose-coated, controlled release capsule formulation of mesalamine designed to release therapeutic quantities of mesalamine throughout the gastrointestinal tract. In April 1998, exclusive U.S. marketing rights to PENTASA were acquired from Hoechst Marion Roussel for $136.0 million. Sales of PENTASA in the year ended December 31, 2002 were $87.2 million, representing approximately 8% of our total revenues. Oncology treatments Agrylin Essential thrombocythemia is a chronic disorder associated with increased or abnormal production of blood platelets. Since platelets are involved in blood clotting, their abnormal production can result in the inappropriate formation of blood clots or bleeding, with the consequence of an increased risk of gastrointestinal bleeding, heart attack and stroke. In 1991, the exclusive worldwide license was obtained from Bristol-Myers Squibb to develop, market and sell Agrylin (anagrelide) as an oral treatment for essential thrombocythemia. In March 1997, the NDA for Agrylin was approved in the U.S.. We also market AGRYLIN in Canada and in other countries on a named patient basis. There is no other U.S. or Canadian approved treatment available for essential thrombocythemia. Other current therapies used to reduce excessive platelet production may have disadvantages, such as possible links to leukemogenesis and leukopenia. In December 1998, we received approval for an expanded indication for AGRYLIN for thrombocytosis, secondary to all myeloproliferative diseases, including polycythemia vera and chronic myelogenous leukemia. In January 1999, we purchased the intellectual property rights to Agrylin from Bristol-Myers Squibb for $35.0 million. In the year ended December 31, 2002, our worldwide sales of Agrylin were $119.2 million, representing approximately 11% of our total revenues. In January 2001, the Committee for Proprietary Medicinal Products (CPMP) on behalf of the European Medicines Evaluation Agency (EMEA) granted orphan drug designation to anagrelide for the treatment of essential thrombocythemia. This designation covers the EU, Norway and Iceland, and confers up to ten years market exclusivity for the product following marketing authorization approval. Orphan drug status already applies to anagrelide in the U.S., 8 where market exclusivity is available until 2004, and in Japan where it will run for ten years following marketing approval. The European Marketing Authorization Application (MAA) filing was made in March 2002. Treatments for infections 3TC/EPIVIR, COMBIVIR, TRIZIVIR The Human Immunodeficiency Virus (HIV) is a retrovirus that has been isolated and recognized as the causative agent of Acquired Immunodeficiency Syndrome (AIDS). There are many strains of HIV throughout the world, although they all exhibit the same disease mechanism. The RNA of the virus is converted to DNA using the reverse transcriptase enzyme and the DNA is integrated into the host organisms' genome, where it is able to replicate. According to UNAIDS, in December 2002 there were 42 million adults and children living with the HIV infection worldwide. Estimates suggest that there are 14,000 new infections each day. Lamivudine, which was originally discovered by BioChem and licensed to Glaxo Wellcome in 1990, is the key to the success of this HIV/AIDS treatment franchise. We receive royalties on sales of lamivudine (now marketed in various single and combination formulations, including 3TC/EPIVIR, COMBIVIR and TRIZIVIR), except in Canada, where we have a commercialization partnership with GSK. These products are now sold worldwide. 3TC royalties for the year ended December 31, 2002, were $132.5 million, up 10% on 2001. ZEFFIX Hepatitis B (HBV) virus is the causative agent of both acute and chronic forms of hepatitis B, a liver disease which is a major cause of death and disease throughout the world. Over 2 billion people worldwide have, at some point, been infected with the HBV virus. Of these 2 billion, there are over 350 million people chronically infected, (World Health Organization 2000). Vaccines to prevent HBV are currently available, however, they have not been shown to be effective in those already infected with the virus. Lamivudine has also been shown to be effective against the HBV virus and is marketed as ZEFFIX and various other trademarks around the world. In an agreement similar to that for lamivudine in HIV/AIDS, we receive royalties on sales of lamivudine by GSK for HBV except in Canada, where we have a commercialization partnership with GSK. ZEFFIX royalties for the year ended December 31, 2002, were $21.2 million, up 25% on 2001. Treatments for other diseases CALCICHEW range Osteoporosis is characterized by a progressive loss of bone mass that renders bone fragile and liable to fracture. More than 3 million people in the U.K. are estimated to suffer from this condition. Osteoporosis affects both sexes but is more rapid and profound in women, largely as a result of the decline in oestrogen production following menopause. Our principal products for the adjunctive treatment of osteoporosis are the CALCICHEW range of calcium and calcium/vitamin D supplements which are sold mainly in the U.K. and the Republic of Ireland. Our CALCICHEW range includes, CALCICHEW(R) 500mg, CALCICHEW FORTE(R), CALCICHEW-D3(R) and CALCICHEW-D3 FORTE(R). We believe this range is more palatable than alternative products. We hold a leading position in the (pound)20 million (approximately $29 million) U.K. prescription calcium market. PROAMATINE In 1996, PROAMATINE was given accelerated approval by the FDA as a new drug for life-threatening illnesses and is currently the only FDA approved treatment for orthostatic hypotension. This is a condition involving low blood pressure upon assuming an upright posture, resulting in dizziness, weakness or unconsciousness. PROAMATINE has been 9 designated as an orphan drug by the FDA, giving it a seven year period of market exclusivity in the U.S., which will expire in September 2003. Sales of ProAmatine in 2002 were $50.9 million, representing approximately 5% of our total revenues. Products under development We seek to maintain a broad and balanced approach to our development of new products by, among other things, leveraging third-party research and development expertise, exploiting investment in research collaborations and licensing compounds from third parties and developing them through the pre-clinical and clinical phases, with a view to marketing them by our own sales and marketing organization. Recognizing the risks in drug development, our policy is to manage this by maintaining a broad range of products in different development phases and with varying inherent levels of risk, from low risk reformulations of off-patent approved compounds, through to higher risk new chemical entities, although we do not focus on non-validated targets. We aim to optimize the level of fixed overhead by using contract research organizations to manage multi-center and/or international clinical trials on a day-to-day basis. In the year ended December 31, 2002, we spent $189.2 million on research and development, representing approximately 18% of our total revenues. The table below lists our key products under development by therapeutic area, indicating their most advanced development status for any market and their territorial rights.
Most advanced development Product(s) Principal indication(s) status Shire's territorial rights - --------- ----------------------- -------------------------- -------------------------- Treatments for central nervous system disorders SPD417 Bipolar disorder Phase III Global SPD451 Parkinson's disease Preclinical Global SPD473 ADHD Phase I Global SPD503 ADHD Phase III Global SPD465 ADHD Phase I Global SPD483 ADHD Preclinical Global SPD485 ADHD In registration in U.S. Global Treatments for gastro intestinal diseases SPD476 Ulcerative colitis Phase II Global SPD480 Ulcerative colitis Phase II Global PENTASA (500mg) Ulcerative colitis Phase II U.S. Balsalazide Ulcerative colitis Phase II complete(2) Certain countries within Europe Oncology treatments AGRYLIN(R)/ XAGRID(R) Essential thrombocythemia In registration in Europe(1) Global TROXATYL(R)(troxacitabine) AML Phase II Global TROXATYL Pancreatic cancer Phase II Global 10 Most advanced development Product(s) Principal indication(s) status Shire's territorial rights - --------- ----------------------- -------------------------- -------------------------- Treatments for infections SPD701 Influenza vaccine(3) Phase I Global SPD703 Streptococcus pneumoniae Phase I Global vaccine SPD704 Neisseria meningitidis Phase I Global vaccine SPD705 Pseudomonas aeruginosa Phase I Global vaccine(4) SPD707 Influenza vaccine Phase II(5) Global SPD754 HIV Phase II Global SPD756 HIV Phase I Global
Most advanced development Product(s) Principal indication(s) status Shire's territorial rights - --------- ----------------------- ------------------------- -------------------------- Treatments for other diseases FOSRENOL(R)(Ianthanum carbonate)(6) Hyperphosphataemia In registration EU, U.S. and Global Canada In Phase 1 in Japan
1 This product is marketed in the U.S. and Canada under the trademark AGRYLIN and is currently in registration in Europe, under the name XAGRID. 2 This product is marketed in the U.K. by us and in various European countries by our distributors. Shire has rights for various European markets. 3 This influenza vaccine antigen is produced in cell culture, in contrast to SPD707, which is produced in chicken eggs. 4 The initial Phase I clinical trial is being conducted by Cytovax Biotechnologies. 5 This product is marketed in Canada under the trademark FLUVIRAL S/F(R) and is under development for markets outside of Canada. 6 This project is referred to as FOSRENOL throughout this document, but was previously known as Project Lambda or Foznol. Treatments for central nervous system disorders SPD417 for bipolar disorder SPD417 is a project that capitalizes on the success of CARBATROL, which we currently market in the U.S. for the treatment of epilepsy. There is anecdotal evidence that carbamazepine, the active ingredient in CARBATROL, may work as a treatment for bipolar disorder. The aim of this project is to investigate the efficacy of CARBATROL in clinical trials for bipolar disorder, with a view to gaining FDA approval for this indication. The project is currently in Phase III. ADHD products A successful sNDA filing for ADDERALL XR was made in 2001, culminating in the U.S. launch on November 5, 2001. An sNDA for ADDERALL XR was also filed in the U.S. for the Adult ADHD indication in December 2002. ADDERALL XR is currently in registration in Canada. We have five further projects in development for ADHD; SPD473, SPD503, SPD465, SPD483 and SPD485. 11 SPD473 SPD473 is a multiple monoamine reuptake inhibitor acting on dopamine, noradrenaline and 5-HT. Activity is focused on proof of concept in ADHD. Parkinson's disease and depression indications have been explored but are not being progressed. Shire also has two new life cycle projects for the ADDERALL franchise, SPD465 and SPD483, which are in Phase I and preclinical stage respectively. SPD503 SPD503 is a potentially non scheduled compound and is in Phase III. The compound is an established chemical entity that has been reformulated by Shire for use in ADHD. SPD485 On February 27, 2003, Shire announced the acquisition of the worldwide sales and marketing rights of METHYPATCH, from Noven Pharmaceuticals Inc. METHYPATCH/SPD 485, is a methylphenidate transdermal delivery system, for the once-daily treatment of ADHD, which was filed with the U.S. FDA on June 27, 2002. The acquisition of METHYPATCH will enable Shire to develop a new presence in the methylphenidate segment of the market which currently represents over half of the U.S. ADHD prescription volume. METHYPATCH has a technology patent until 2012 and composition patents in the U.S. and other key markets until December 2018. Epilepsy Epilepsy is a condition currently affecting a large market of approximately 2.3 million people in the U.S. Shire maintains interest in a number of possible treatments for this condition, with the aim of building a franchise based on our existing U.S. marketed product, CARBATROL. Shire has recently reviewed a series of results from studies on the epilepsy project SPD421 and has concluded that it does not meet Shire's criteria to warrant investment in Phase III studies. The licensor, D-Pharm Ltd., has indicated its intent to continue development and Shire is therefore currently discussing the return of the project to D-Pharm. Shire has also decided not to pursue two potential reformulation projects in epilepsy, designated SPD452 and SPD453. Instead, Shire is actively reviewing other potential in-licensing projects for epilepsy and related disorders. Parkinson's disease Parkinson's disease is a relatively common disease that causes a progressive loss of movement, rigidity, postural abnormalities and tremor. Shire obtained the rights to a dopamine D1 agonist project, SPD451, in December 2000, when it was in-licensed from CeNeS Pharmaceuticals plc. This project is currently in the preclinical stage of development. SPD474 is a dopamine reuptake inhibitor that was licensed from an undisclosed third party in December 2001. This compound showed insufficient evidence of efficacy and work has been terminated. Treatments for gastro intestinal diseases Ulcerative colitis is a serious chronic inflammatory bowel disease of the colon and rectum. Typically patients go through periods of relapse and remission over a number of years. 5-ASA (5-aminosalicylic acid) based products are the first line treatment for ulcerative colitis. Existing treatments have a large pill burden and are differentiated on the release mechanism and targeting. 12 PENTASA for ulcerative colitis PENTASA 250mg is a 5-ASA based product marketed by Shire in the U.S for ulcerative colitis. A 500mg dosage form is being developed to aid compliance in patients, who often need to take large doses of this medication. COLAZIDE for ulcerative colitis In May 2000, we in-licensed rights to COLAZIDE, a 5-ASA based product for ulcerative colitis, from Salix Pharmaceuticals Inc. The first launch was in the U.K. in September 2000. SPD476 SPD476 is being developed as a high strength (1200mg) 5-ASA based product for ulcerative colitis using a unique formulation and delivery platform. Rights to SPD476 in key global markets were licensed from Giuliani SpA. on May 6, 2002. The project is currently in Phase II. SPD480 SPD480 is a 5-ASA based product formulated as a foam for rectal delivery in the treatment of ulcerative colitis. Rights to key global markets were licensed from Giuliani SpA on October 10, 2002. This product will provide an alternative treatment for distal/rectal ulcerative colitis. Oncology treatments AGRYLIN for essential thrombocythemia We market anagrelide as AGRYLIN in the U.S. and Canada for the treatment of essential thrombocythemia, where it is the only medicine approved for this condition. We are continuing to develop anagrelide for other countries, where it may be marketed as AGRYLIN or XAGRID. In January 2001, the Committee for Proprietary Medicinal Products (CPMP) on behalf of the European Medicines Evaluation Agency (EMEA) granted orphan drug designation to anagrelide for the treatment of essential thrombocythemia. This designation covers the EU plus Norway and Iceland, and confers up to ten years market exclusivity for the product following marketing authorization approval. Orphan drug status already applies to anagrelide in the U.S., where market exclusivity is available until 2004, and in Japan where it will run for ten years following marketing approval. The European Marketing Authorization Application (MAA) filing was made in March 2002. TROXATYL for acute myeloid leukemia (AML) and pancreatic cancer TROXATYL is initially being clinically evaluated for two types of cancer; AML and pancreatic cancer. In children, cancer is second only to accident as a cause of death and leukemia is the most common form of cancer found in this age group. In 2002 there have been an estimated 30,000 new cases of pancreatic cancer across North America. Studies to date have shown that TROXATYL is a complete DNA chain terminator and DNA polymerase inhibitor. As such, it appears to incorporate itself into the growing DNA chain of cancer cells, interfering with their ability to replicate further. Unlike other cytidine analogues currently used in cancer therapy, TROXATYL is not degraded by cytidine deaminase. Both projects are currently studying combination use with other agents and are in Phase II. Treatments for infections (i) influenza vaccines SPD707 SPD707, a split-virion influenza vaccine, was introduced as a project during the third quarter of 2001. It is already manufactured and marketed by us in Canada as FLUVIRAL S/F. We are now capitalizing on our global rights to FLUVIRAL S/F by investigating its potential for other markets, primarily the U.S. and Europe. This project is considered 13 to be at the end of Phase II, since Phase III data will be needed to support marketing approval applications in the major markets. On October 29, 2001, we announced that Shire Biologics had signed a ten-year contract with the Government of Canada to assure a state of readiness in the case of an influenza pandemic (worldwide epidemic) and to provide influenza vaccine for all Canadian citizens in such an event. Under the contract, Shire Biologics will also supply the Government of Canada with a substantial proportion of its annual influenza vaccine requirements over the ten-year period. It has been estimated that the sales value of the agreement may exceed CAN$300 million (approximately $190 million). SPD701 SPD701 is a cell-based influenza vaccine. Prior to our merger, BioChem announced in its first quarter 2001 financial results that the agreement with GSK to develop SPD701 had been terminated. In our third quarter 2001 financial results we announced that we were negotiating a termination of the research agreement with BioVector and confirmed that development of both the nasal and injectable formulations of SPD701 will not continue until a new partner has been found. HIV Our expertise in HIV that led to the discovery of 3TC has also led to the discovery of two further antiretroviral compounds; SPD756 (formerly BCH 13520) and SPD754 (formerly BCH 10618). SPD754 SPD754 is a nucleoside (cytidine) analogue that also reduces the rate of replication of HIV. Preclinical data indicates that SPD754 is active against HIV strains which have developed resistance to other nucleoside analogues such as AZT and 3TC, as well as against clinical isolates of HIV-1 that are highly resistant to a range of nucleoside analogues. As with SPD756, preclinical studies indicate that viral resistance to SPD754 appears to develop very slowly. SPD754 is currently in Phase II of development. SPD756 SPD756 is a potent nucleoside (guanosine) analogue. It is a nucleoside reverse transcriptase inhibitor. It has been shown in vitro to retain efficacy against resistant clinical isolates including multiple and highly resistant strains of HIV. In preclinical studies viruses resistant to SPD756 emerged slowly. This project entered Phase I clinical studies during the third quarter of 2001. This project is currently subject to additional testing to determine if it should progress to studies in humans. (ii) antibacterial vaccines There is a great need for new antibacterial vaccines, especially given the increasing resistance of many bacteria to current antibiotics. As existing vaccines often do not provide effective immunisation against many deadly bacteria, we are developing a new generation of antibacterial vaccines based on innovative recombinant protein technology. In April 2000, we concluded a partnership agreement with the Canadian government though Technology Partnerships Canada (TPC). Under the agreement, the Canadian government has agreed to contribute up to CAN$80 million (approximately $51 million) in the development of recombinant protein vaccines over a period of approximately six years. For the year ended December 31, 2002, the contributions due from the Canadian government amounted to CAN$3.1 million (approximately $2.0 million) based on eligible research and development expenditure. This contribution is accounted for as a reduction against research and development costs charged to operations. We have three vaccines in development against the following bacteria: Neisseria meningitidis, Streptococcus pneumoniae and Pseudomonas aeruginosa. SPD704 - Neisseria meningitidis vaccine Our meningococcal vaccine candidate, SPD704, is designed to protect against infection by N. meningitidis. Two of the most common outcomes of infection by N. meningitidis are meningococcal meningitis and septicaemia. 14 Existing polysaccharide vaccines and current and future polysaccharide conjugate vaccines against N. meningitidis only protect against four of the 12 serogroups of N. meningitides. However, none protect against serogroup B, the most common strains of the bacteria in industrialised countries such as Canada, the U.S. and the U.K. SPD704 appears to have the potential to induce a potent and long-lasting immunity against all strains of N. meningitidis, including type B. If these properties are confirmed in clinical trials, our recombinant protein vaccine against N. meningitidis will be a significant medical advance. This vaccine is currently in Phase I clinical trials. SPD703 - Streptococcus pneumoniae vaccine We believe that our protein-based vaccine, SPD703, should more effectively stimulate the immune system and has the potential to provide improved protection for children and older people alike across all S. pneumoniae strains. This project is at Phase I of development. SPD705 - Pseudomonas aeruginosa vaccine P.aeruginosa is one of the leading causes of life-threatening nosocomial (hospital acquired) infections. It causes chronic degenerative pulmonary disease in cystic fibrosis patients and can cause death in 30% of immunocompromised patients. There is a high and increasing level of antibiotic resistance to this bacteria. We are collaborating with Cytovax Biotechnologies Inc. (Cytovax) in the development of a vaccine against P. aeruginosa, known as SPD 705. This project moved into Phase I of development in February 2002, for which Cytovax Biotechnologies is conducting the ongoing Phase I trial. Treatments for other diseases FOSRENOL for hyperphosphatemia FOSRENOL (lanthanum carbonate) is being developed for the prevention and treatment of high levels of phosphate in the blood of patients with chronic kidney failure. The body absorbs phosphate from food and any excess to requirements is excreted in urine. Hyperphosphatemia arises from damaged kidneys being unable to eliminate from the body the excess dietary phosphate that is widespread in food. Renal dialysis and a restricted diet are generally unable to reduce these phosphate levels sufficiently. If left untreated, hyperphosphataemia can lead to the bone disease, renal osteodystrophy, which causes bone pain, skeletal deformities, and can result in fractures. Recent research also suggests that hyperphosphataemia is associated with the development of cardiovascular disease, which accounts for nearly 50% of all deaths in dialysis patients. Taking lanthanum carbonate with food results in the formation of lanthanum phosphate, which cannot pass easily through the gut lining into the blood stream. As a consequence, phosphate absorption from the diet is decreased. As FOSRENOL does not contain calcium it enables the physician to separate the control of calcium from phosphate. In addition, since chronic kidney failure patients are severely fluid restricted, FOSRENOL is presented as a chewable tablet. It is estimated that there are one million patients worldwide with end-stage renal disease. We believe that current therapies are not ideal: aluminum salts can cause bone and/or neural toxicity and are no longer widely used, and calcium salts are inefficient binders requiring large doses and often causing hypercalcaemia, which among other things, can result in calcification of blood vessels. Other treatment options involve high pill burden and/or add to the patients fluid intake needs. On March 3, 2003 Shire received an approvable letter from the U.S. Food & Drug Administration (FDA) for FOSRENOL. The approvable letter asks for additional data and analysis to address a number of remaining questions. Shire is initiating a dialogue with the FDA to agree the balance between pre and post approval commitments which will resolve the questions. Shire will give further updates when it is in a position to be more specific about the timing of approval and subsequent launch. Submissions have also been made by Shire to gain marketing approval for FOSRENOL in Europe and Canada, whilst development continues for Japan. Drug delivery technologies We have several platforms of drug delivery technologies that can be applied to drugs in order to enhance their effectiveness or their convenience to patients. Generally, this involves reformulating the drug into a new delivery system designed either to enhance the absorption of the drug into the blood stream or, alternatively, to delay absorption of the drug into the bloodstream, thereby requiring the patient to take fewer daily doses. 15 Our portfolio of drug delivery technologies includes technologies to predict and enhance bioavailability of drugs as well as technologies to develop oral controlled release profiles. These technologies are available to third parties in return for development fees, licensing fees, milestone payments and royalties. We have employed these technologies selectively to develop our own unique products such as CARBATROL and ADDERALL XR and intend to continue doing so in the future. (iii) Manufacturing and distribution ADDERALL XR is manufactured by DSM Pharmaceuticals Inc. (DSM). We manufactured and packaged ADDERALL and DEXTROSTAT(R) at our facility in Valley Stream, New York throughout 2002. Shire received approval from the FDA to transfer production of ADDERALL to DSM in 2002. DEXTROSTAT production will be transferred to DSM in 2003. Our other products marketed in the U.S. and Canada are manufactured and packaged by third party contract manufacturers, except vaccines which are manufactured by Shire in Quebec, Canada. In February 2003, Shire discontinued production at the Valley Stream facility and in June 2001, we sold our pharmaceutical manufacturing facility located in Oakville, Ontario. These actions are part of a coordinated initiative to upgrade manufacturing capacity and rationalize non-strategic manufacturing and distribution facilities within North America. On September 27, 2002, Shire acquired APS which includes a state-of-the-art manufacturing facility located in Owings Mills, Maryland. It is expected that the APS facility will become a primary or secondary supplier for ADDERALL XR, CARBATROL, and PENTASA by 2005. The acquisition of APS mitigates our supply risk in the U.S. and compliments our policy of dual sourcing key products. As part of the acquisition agreement of METHYPATCH, Noven Pharmaceuticals Inc. will manufacture this product . Our U.S. distribution center, which includes a large vault to house DEA regulated Schedule II products, is located in Northern Kentucky. From there, we distribute our ADHD products to nearly all the wholesale distribution centers and the three major warehousing pharmacy chains that stock Schedule II drugs in the U.S., providing access to nearly all pharmacies in the U.S. We distribute other products from a facility located in a suburb of Chicago. All products marketed by the U.K. based sales and marketing operation are either manufactured and supplied by the originator of the product under supply arrangements or are manufactured for us by third parties under contract. Distribution in the U.K., Spain, Italy, France, Germany, the Republic of Ireland and to other export territories is also contracted out to third parties. We have access to all principal drug wholesale chains in the U.K. and the Republic of Ireland and their respective distribution centers. In the U.S., our significant customers include McKesson Corp., Cardinal Health Inc. and Bergen Brunswig Corp. In the U.K., our significant customers include The Boots Company plc, AAH Pharmaceuticals Limited and Unichem plc. For the fiscal year ended December 31, 2002, our three largest customers, McKesson Corp., Cardinal Health Inc. and Bergen Brunswig Corp, accounted for approximately 22%, 19% and 14% of total revenues, respectively. The loss of any one of these three U.S. customer accounts could have a material adverse effect on our financial condition and results of operations. (iv) Intellectual property An important part of our business strategy is to protect our products and technologies through the use of patents, proprietary technologies and trademarks, to the extent available. Our success will depend, in part, upon our ability to obtain and enforce strong patents, to maintain trade secret protection and to operate without infringing the proprietary rights of others. Our policy is to seek patent protection for our proprietary technology whenever possible in the U.S., Canada, major European countries and Japan. Where practicable, we seek patent protection in other countries on a selective basis. In all cases, we endeavor to either obtain patent protection ourselves or support applications by our licensors. On February 11, 2002 Barr Laboratories Inc. (Barr) announced FDA approval to market a generic version of the original ADDERALL formulation, which is not patent protected. Since then, several other companies have also obtained approval and launched generic versions of ADDERALL. 16 In November 2002 we received approval from the FDA for a new formulation of ADDERALL which is patent protected. In January 2003 we received a Paragraph IV notice from Barr alleging that this patent is invalid and not infringed by Barr's 7.5 mg, 12.5 mg and 15 mg mixed amphetamine salt products. The Company has taken no action with respect to this notice and Barr announced in March 2003 that it has now received FDA approval and 180 days exclusivity for these strengths . The Company received a second Paragraph IV notice in March 2003 from another generic alleging that this patent is invalid and is not infringed by its products, which are the subject of a pending ANDA. The Company is reviewing this notice . If the Company does not bring a suit or does not prevail in any such suit then this company would be able to market its product upon FDA approval of its ANDA application, subject to Barr's exclusivity period for the above doses. The sales of any generic versions of ADDERALL may have a material adverse impact on the Company's results and financial position . Our extended release once daily version of ADDERALL, ADDERALL XR, is covered by U.S. patent No. 6,322,819 (the '819 Patent). In January 2003 we received a Paragraph IV notice from Barr alleging that this patent is invalid and not infringed by Barr's extended release mixed amphetamine salt product which is the subject of a Barr pending ANDA application. On February 24, 2003 Shire Laboratories Inc. filed suit against Barr in the U.S. District Court for the Southern District of New York for infringement of the '819 Patent with respect to this ANDA. The Hatch-Waxman Act provides for an automatic stay of up to 30 months of FDA approval for Barr's ANDA to market its generic version of ADDERALL XR to allow the Court to resolve the patent infringement lawsuit. However, there can be no assurance that the Company will be successful in the suit. In the event that the Company does not prevail, then Barr could be in a position to market its extended release mixed amphetamine salt product upon FDA final approval of its ANDA application. This may have a material adverse impact on the Company's results and financial position. In the event that the Company does not prevail in the suit, a generic version of ADDERALL XR could not be launched before October 2004, the current expiry of the existing Hatch-Waxman exclusivity. We have issued patents and pending applications in the U.S., Canada, most European countries, Japan and selected countries worldwide in the areas of therapeutics and biologics, including patents and applications relating to our products, our process technologies and, where appropriate, in respect of the formulation of products made by those processes or incorporating those technologies. We cannot however assure you that our patents or patent applications or those of our third party manufacturers will provide valid patent protection sufficiently broad to protect our products and technology and will not be challenged, revoked, invalidated, infringed or circumvented by third parties. In the regular course of business, we are a party to litigation or other proceedings relating to intellectual property rights. We also rely on trade secrets, unpatented know-how and technological innovations, trademarks and contractual arrangements with third parties to maintain and enhance our competitive position where we are unable to obtain patent protection or our marketed products are not covered by specific patents. Our commercial success will depend in part on our not infringing patents or proprietary rights of others and not breaching licenses granted to us. The degree of patent protection afforded to pharmaceutical or biological inventions around the world is uncertain. We are aware of certain issued patents and patent applications of third parties, and there may be other patents and patent applications containing subject matter which we, or our licensees, may require in order to research, develop or commercialize certain of our products and technologies. If patents are granted to other parties that contain claims having a scope that is interpreted by the relevant authorities to cover any of our products or technologies, there can be no guarantee that we will be able to obtain licenses to such patents or make other arrangements at reasonable cost, if at all. Failure to obtain a license to any technology or patents that we may require to commercialize our products or technology may result in material adverse effects on the sale or development of the product or technology in question and lead to the abandonment or delay in development, manufacture or sale of that product or technology and additional expenses. Our licensors hold issued patents in the U.S., Europe and Japan relating to the use of galantamine for the treatment of Alzheimer's disease and related dementias. Our licensors hold an issued patent in the U.S., a granted patent in Europe and pending applications in selected other countries relating to the phosphate binder which we are developing for use in the treatment of hyperphosphatemia. 17 We have numerous issued patents in the U.S. claiming nucleoside analogues, methods of treatment using nucleoside analogues and processes for producing these nucleoside analogues. These patents include claims covering the chemical composition of lamivudine and related nucleoside analogues and methods of treating viral infections, including HIV and hepatitis B with lamivudine and related nucleoside analogues. We also have issued patents and pending applications covering lamivudine, TROXATYL, SPD 756, SPD 754 and related nucleoside analogues, processes for their preparation and methods of using the same in over 100 countries, including the U.S., Europe and Japan. (v) Competition We believe that competition in our markets is based on, among other things, product safety, efficacy, convenience of dosing, reliability, availability and price. Companies with more resources and larger research and development expenditures have a greater ability to fund research and clinical trials necessary for regulatory applications, and may have an improved likelihood of obtaining approval of drugs that would compete with our drugs. Prior regulatory approvals for competing products would force our development products to compete with an established drug. Other products now in use or under development by others may be more effective or have fewer side effects than our current or future products. Competition in the U.S. ADHD market continues to increase. Eli Lilly launched Straterra in January 2003, a non-stimulant, non-scheduled treatment for ADHD. We are also aware of clinical development efforts by GSK, Gliatech, Cortex, Boehringer Ingelheim, Cephalon, Eisai, Bristol-Myers Squibb (in collaboration with Elan) and Abbott to develop additional indications and new non-stimulant treatment options for ADHD. With regard to the current stimulant class medications, we are also aware of efforts by Celgene and Celltech Chiroscience plc to develop a single isomer version of methylphenidate. In 2002, Novartis (in conjunction with Elan) launched Ritalin LA, an extended release formulation of methylphenidate and Focalin (in conjunction with Cellgene), a short-acting formulation of dexmethylphenidate, the active isomer of traditional methylphenidate preparations. In 2001, Celltech (in collaboration with Eurand) launched Metadate CD, an extended release formulation of methylphenidate. Generic competition to our ADHD franchise is separately discussed within Intellectual Property and Risk Factors. (vi) Principal licensing and collaborative agreements Various Galantamine agreements Pursuant to an agreement with Synaptech Inc., the owner of the patents on galantamine for use in the treatment of Alzheimer's disease, we have undertaken technical, pre-clinical and clinical work on the use of REMINYL in Alzheimer's disease and related dementias and have agreed to pay royalties on sales of REMINYL. We have also entered into a co-development agreement with Janssen under which we licensed to Janssen all of our clinical data and know-how relating to the use of galantamine in Alzheimer's disease and related dementias worldwide, except for the U.K. and the Republic of Ireland. Under these arrangements, Janssen undertook to finance substantially all the future research and development costs of REMINYL as a treatment for Alzheimer's disease and related dementias, conduct clinical trials, obtain regulatory approvals and manufacture and market REMINYL. Our rights to develop, manufacture and sell REMINYL for use in the treatment of Alzheimer's disease and related dementias under the patents of Synaptech extend throughout the world, but exclude North America, Japan, Korea, Taiwan, Thailand and Singapore. We have, in turn, entered into a sub-license with Janssen under which we granted Janssen exclusive rights to develop, manufacture and sell REMINYL for use in Alzheimer's disease in all territories licensed to us, except the U.K. and the Republic of Ireland. We also have the right to reacquire the rights to sell REMINYL in one of a specified group of major European countries five or 10 years after commercial launch. Janssen has entered into a separate license agreement with Synaptech covering North America, Japan, Korea, Taiwan, Thailand and Singapore. Synaptech authorized us to enter into the above co-development agreement and the above sub-license agreement with Janssen, under which, among other things, we will receive royalties on sales of REMINYL by Janssen in 18 the U.S. As a result, we are dependent on Janssen for revenues derived from REMINYL. Moreover, there can be no assurance that our interests will continue to coincide with those of Janssen. The co-development agreement and sub-license granted to Janssen may be terminated by Janssen on 90 days' notice. If Janssen exercises its right to terminate the license and co-development agreement under this provision, the licenses granted to Janssen (part of the Johnson & Johnson Group) terminate and Janssen is also obligated to transfer to us data and other information and responsibility for the management of continuing development and registrations of the product. The costs of ongoing studies will be shared by us and Janssen in the relevant proportions in the agreement for three months after the date of termination, except for the costs payable for clinical trials, which will be shared until they can be properly terminated. Under the agreement we have the right to complete the registration of the products and seek alternative partners. Lamivudine By agreement between Shire BioChem and GSK dated January 31, 1990 and amended as of November 20, 1995, Shire BioChem licensed to GSK the worldwide rights, with the exception of Canada, to develop, manufacture and sell the nucleoside analogue lamivudine marketed as 3TC, ZEFFIX, HEPTODIN, HEPTOVIR, EPIVIR, EPIVIR-HBV, COMBIVIR and TRIZIVIR (together referred to in this section as "lamivudine"). A partnership exists between GSK's Canadian subsidiary, GSK Inc., and Shire BioChem to supply, market and sell lamivudine in Canada. GSK has agreed to manufacture all the required lamivudine to be supplied in Canada by the partnership. In consideration for the grant of such rights, GSK agreed to undertake and fund the development of lamivudine and to pay Shire BioChem a royalty on sales of lamivudine. The amount of relevant patent prosecution costs certain contractual and litigation costs may be deducted from royalties payable to Shire BioChem by GSK. If GSK terminates the license agreements upon certain events of default by Shire BioChem, GSK will retain a non-exclusive, paid-up license from Shire BioChem to make, have made, use and sell lamivudine worldwide. PROAMATINE By agreement dated November 23, 2000, we re-negotiated the terms and duration of our distribution agreement with Nycomed Austria GmbH for the supply of PROAMATINE in the U.S., Canada, the U.K. and the Republic of Ireland. We now have exclusive rights to supply PROAMATINE in these countries until 2010. FLUVIRAL The Company signed a ten-year contract with the Government of Canada in 2001 to assure a state of readiness in the case of an influenza pandemic (worldwide epidemic) and to provide influenza vaccine for all Canadian citizens in such an event. Under the contract, Shire Biologics will also supply the Government of Canada with a substantial proportion of its annual influenza vaccine requirements over the ten-year period. The value of the agreement may exceed C$300 million (approximately $190 million) over the ten-year term, with an option for the Government of Canada to extend the contract. The concept of a state of readiness against an influenza pandemic requires the development of sufficient infrastructure and capacity in Canada to provide 100% of domestic vaccine needs in the event of an influenza pandemic. Canada would require 32 million doses of single-strain (monovalent) flu vaccine within a production period of 16 weeks. Shire Biologics has begun to expand its production capacity in order to meet this objective within a five-year period. Shire Biologics is committed to CAN$18 million (approximately $11.3 million) of capital expenditure on immoveables for the purpose of achieving the level of Pandemic Readiness required. In addition, a performance bond equal to 10% of the minimum estimated contract value in any year, which for 2002/2003 will be CAN$19.2 million (approximately $12 million), would become payable to the Government of Canada if contracted penalty clauses were triggered. Johnson Matthey--FOSRENOL Johnson Matthey plc has granted patents in the U.S. and Europe and pending applications elsewhere for pharmaceutical compositions containing lanthanum carbonate and to use of these compositions for the treatment or prevention of hyperphosphatemia. In February 1996, we entered into an agreement with Johnson Matthey under which Johnson Matthey granted to us an exclusive license agreement to develop, manufacture, use and sell FOSRENOL worldwide in consideration of an upfront payment and a royalty on sales of FOSRENOL. We have consented to the assignment by Johnson Matthey of its patents to AnorMed Inc., a Canadian company, which is partially owned by 19 Johnson Matthey. As part of these arrangements we amended the agreement and received an exclusive worldwide license to use Johnson Matthey's manufacturing know-how in return for up front payments and future royalties. (vii) Government regulation The clinical development, manufacturing and marketing of our products are subject to regulation by various authorities in the U.S., the EU and other international territories, including, in the U.S., the FDA, the DEA and the Occupational Safety and Health Administration, and in the U.K., principally the Medicines Control Agency (MCA). The Federal Food, Drug, and Cosmetic Act, the Public Health Service Act in the U.S. and numerous directives and guidelines in the EU govern the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of our products. Product development and approval within these regulatory frameworks takes a number of years and involves the expenditure of substantial resources. Regulatory approval will be required in all the major markets in which we, or our licensees, seek to test or market products. At a minimum, such approval requires the evaluation of data relating to the quality, safety and efficacy of a product for its proposed use. The specific types of data required and the regulations relating to this data will differ depending on the territory, the drug involved, the proposed indication and the stage of development. In general, for a new chemical entity, the product needs to undergo rigorous preclinical testing before it can be used in humans, both in the laboratory and, until suitable alternative tests are found, in animals. Clinical trials for new products are typically conducted in three sequential phases that may overlap. In Phase I, the initial introduction of the pharmaceutical into healthy human volunteers, the emphasis is on testing for safety (adverse effects), dosage tolerance, metabolism, distribution, excretion and clinical pharmacology. Phase II involves studies in a limited patient population to determine the initial efficacy of the pharmaceutical for specific targeted indications, to determine dosage tolerance and optimal dosage and to identify possible adverse side effects and safety risks. Once a compound is found to be effective and to have an acceptable safety profile in Phase II evaluations, Phase III trials are undertaken to more fully evaluate clinical outcomes. In the U.S., data, as described above, needs to be submitted to the FDA as part of an Investigational New Drug (IND) application which, unless the FDA objects, will become effective 30 days following receipt by the FDA. Phase I studies in human volunteers may commence only after the application becomes effective. Prior regulatory approval for human healthy volunteer studies is not currently required in the U.K., although the same level of testing will need to have been completed before we decide it is safe to proceed. In the U.K., following successful completion of Phase I studies, data is submitted in summarized format to the MCA as a Clinical Trial Certificate exemption (CTX) application in support of a specific Phase II clinical study or program. The MCA has 35 days in which to raise any objections to the proposed study, or to extend this review period by a further 28 days at its discretion. For any additional studies, Phase II and/or Phase III, further submissions to regulatory authorities are necessary to update the existing IND and/or CTX. Authorities may require additional data before allowing the studies to commence and could demand the studies be discontinued at any time if there are significant safety issues. In addition to the regulatory review, a study often has to be approved by an independent body. The exact composition and responsibilities of this body will differ from territory to territory. In the U.S., for example, each study will be conducted under the auspices of an independent Institutional Review Board at the institution at which the study is conducted. This board considers among other things, the design of the study, ethical factors, the safety of the human subjects and the possible liability risk for the institution. The U.K. equivalent of this body, the Ethics Committee, has a very similar approach. Other authorities around Europe and the rest of the world have slightly differing requirements involving both the execution of clinical trials and the import/ export of pharmaceutical products. It is our responsibility to ensure we conduct our business in accordance with the regulations of each relevant territory. Information generated in this process is susceptible to varying interpretations that could delay, limit or prevent regulatory approval at any stage of the approval process. The failure to demonstrate adequately the quality, safety and efficacy of a therapeutic drug under development would delay or prevent regulatory approval of the product. There can be no assurance that if clinical trials are completed, either we or our collaborative partners will submit applications for required authorizations to manufacture and/or market potential products (including a marketing authorization application, NDA or abbreviated NDA) or that any such application will be reviewed and approved by the appropriate regulatory authorities in a timely manner, if at all. In order to gain marketing approval we must submit a dossier to the relevant authority for review. The format is usually specific and laid out by each authority, although in general it will include information on the quality (chemistry, manufacturing and pharmaceutical) aspects of the product as well as the non-clinical and clinical data. The FDA undertakes the review for the U.S.; in Europe the review may be undertaken by members of the CPMP on behalf of the 20 EMEA as part of a centralized procedure or by an individual country's agency, followed by "mutual recognition" of this review by a number of other countries' agencies, depending on the process applicable to the drug in question. Approval can take several months to several years, or be denied. The approval process can be affected by a number of factors; additional studies or clinical trials may be requested during the review and may delay marketing approval and involve unbudgeted costs. The agency may conduct an inspection of relevant facilities, review manufacturing procedures, operating systems and personnel qualifications. In addition to obtaining approval for each product, in many cases each drug manufacturing facility must be approved. Further inspections may occur over the life of the product. An inspection of the clinical investigation sites by a competent authority may be required as part of the regulatory approval procedure. As a condition of approval, the regulatory agency may require post-marketing surveillance to monitor for adverse effects, or other additional studies as deemed appropriate. After approval for the initial indication, further clinical studies are usually necessary to gain approval for any additional indications. The terms of any approval, including labeling content, may be more restrictive than expected and could affect the marketability of a product. In the U.S., the Drug Price Competition and Patent Restoration Term Act of 1984, known as the Hatch-Waxman Act, established abbreviated application procedures for obtaining FDA approval for many brand name drugs that are off-patent and whose marketing exclusivity has expired. Approval to manufacture these drugs is obtained by filing an abbreviated new drug application. As a substitute for conducting full-scale pre-clinical and clinical studies of the brand name drug, the FDA requires data establishing that the drug formulation, which is the subject of an abbreviated application, is either bio-equivalent or has the same therapeutic effect as the previously approved drug, among other requirements. The European guidelines also allow for the submission of abridged applications using similar criteria to the U.S. system. For both currently marketed and future products, failure to comply with applicable regulatory requirements after obtaining regulatory approval can, among other things, result in the suspension of regulatory approval, as well as possible civil and criminal sanctions. Renewals in Europe may require additional data, which may result in a license being withdrawn. In the U.S., the FDA has the authority to revoke or suspend approvals of previously approved products, to prevent companies and individuals from participating in the drug-approval process, to request recalls, to seize violative products and to obtain injunctions to close manufacturing plants not operating in conformity with regulatory requirements and to stop shipments of violative products. The FDA also may impose pre-clearance requirements on products currently being marketed without FDA approval. In addition, changes in regulation could have a material adverse effect on our financial condition and results of operation. The DEA also controls the national production and distribution of Scheduled drugs in the U.S. by allocating production quotas based, in part, upon the DEA's view of national demand. As Schedule II drugs, the production and sale of our ADHD products are strictly controlled. (viii) Third party reimbursement Our ability to market products depends in part on the extent to which healthcare providers pay at appropriate reimbursement levels for the cost of the products and related treatment. Third-party payers are increasingly challenging the pricing of pharmaceutical products and/or seeking pharmaco-economic data to justify reimbursement practices. In the U.S., several factors outside of our control could significantly influence the purchase of pharmaceutical products including the ongoing trend toward managed health care, and the renewed focus to reduce costs in state Medicaid and other government insurance programs. However, the prices of our products are fixed and determinable at the outset of each transaction we undertake with our customers, and therefore these factors would not impact the recording of our revenues in accordance with generally accepted accounting principles. Similar developments may take place in the EU markets, where the emphasis will likely be on price controls and non-reimbursement for new and highly priced medicines for which the economic as well as the therapeutic rationales are not established. Significant uncertainty exists about the reimbursement status of newly approved pharmaceutical products. There can be no assurance that reimbursement will be available for any of our products. Limits on reimbursement available from third-party payers may reduce the demand for our products. Price applications in Europe have delayed product launches in some countries for up to two years and as a consequence dates for product launches cannot be predicted with accuracy. (ix) Employees On December 31, 2002, we employed 1,847 individuals, 773 of whom were in sales and marketing, 435 of whom were in research and development, 334 of whom were in manufacturing and distribution, and 305 of whom were in general and administrative. In addition to our employees, we engage professional personnel on a consultancy basis and, from 21 time to time, consultants and others on a per day or hourly basis. We believe that relations with our employees are satisfactory. Our success is dependent on our ability to attract and retain highly qualified management and scientific personnel. We face intense competition for personnel from other companies, academic institutions, government entities and other organizations. We may not be able to successfully attract and retain such personnel. In general, we have agreements with our key scientific and management personnel for periods of one year or less. The loss of such personnel, or the inability to attract and retain the additional highly skilled employees required for our activities, could have an adverse effect on our business. (d) Financial information about foreign and domestic operations Financial information about foreign and domestic operations is presented in note 22 to the consolidated financial statements. (e) Risk factors We have adopted a positive risk management strategy that enables us to identify and manage significant risks that we face. While we aim to identify and manage every significant risk that we face, it is important to recognize that no risk management strategy can provide absolute assurance against loss. Set out below are the key risk factors generally associated with our business that have been identified through our approach to risk management. These, together with other risks generally associated with companies that operate in the pharmaceutical industry, should be carefully considered before any investment is made in our company. (i) The introduction of new products by competitors may impact future revenue The manufacture and sale of specialty pharmaceuticals is highly competitive. Many of our competitors are large, well-known pharmaceutical, chemical and health care companies with considerable resources. Companies with more resources and larger research and development expenditures have a greater ability to fund research and clinical trials necessary for regulatory applications. They may also have an improved likelihood of obtaining approval of drugs that may compete with those marketed or under development by us. If any product, that competes with one of our principal drugs, is approved, sales of our drugs could fall. The pharmaceutical industry is also characterized by rapid product development and technological change. Our products could therefore be rendered obsolete or uneconomical through the development of new products or technological advances in the cost of production or marketing by our competitors. (ii) The failure to secure new products for development may reduce the strength of the future pipeline. Our future results will depend, to a significant extent, upon our ability to discover or in-license research and development projects for development or to acquire new products. The failure to discover, in-license, or acquire projects or products, on a commercially viable basis, could have a material adverse effect on our financial position. (iii) The actions of governments, regulators and customers can affect the ability to sell or market products profitably. Our ability to market our products profitably will depend on the impact on the environments in which we operate, from governments, regulators and customers. In particular, we depend in part on reimbursement levels for the cost of the products and related treatment established by health care providers, including government authorities, private health insurers and other organizations, such as health maintenance organizations and managed care organizations. Third party payers are increasingly challenging the pricing of pharmaceutical products and reviewing their reimbursement practices. In addition, the purchase of pharmaceutical products could be significantly influenced by the following, which would result in lower prices and a reduced demand for our products: o the ongoing trend toward managed health care in the U.S., o a change in the quotas for Scheduled drugs regulated by the DEA, o legislative proposals to reform health care and government insurance programs, or o price controls and non-reimbursement of new and highly priced medicines for which the economic and therapeutic rationales are not established. 22 In both the U.S. and the U.K., a small number of large wholesale distributors control a significant share of each market. In addition, the number of independent drug stores and small chains has decreased as retail pharmacy consolidation has occurred. Consolidation or financial difficulties could cause customers to reduce their inventory levels, or otherwise reduce purchases of our products. (iv) We enter into strategic partnerships for the development and commercialization of our products. The failure of a strategic partner to deliver the required results could result in delays in approval or loss of revenue. We enter into strategic partnerships with other companies in areas such as product development or sales and marketing. In these partnerships, we are dependent on our partner to deliver results. While these partnerships are supported by contracts, we do not exercise direct control. If a partner fails to perform, we may suffer a reduction in sales or royalties or may experience delays in approval of products. (v) The outsourcing of services can create a significant dependency on third parties, the failure of whom can affect the ability to operate our business and to develop and market products. We have entered into many agreements with third parties for the provision of services to enable us to operate our business. In particular, we have entered into agreements with third party contract manufacturers for the supply of our development and marketed products. Many of the components of these products are available only from one supplier. We may not be able to establish or maintain good relationships with the suppliers. Additionally, there is no assurance that the suppliers will continue to exist on commercially viable terms or be able to supply components that meet regulatory requirements. We are also subject to the risk that suppliers will not be able to meet the quantities needed to meet market requirements. The development and approval of our products depends on the ability to procure active ingredients and special packaging materials from sources approved by regulatory authorities. Because the marketing approval process requires manufacturers to specify their own proposed suppliers of active ingredients and special packaging materials in their applications, regulatory approval of a new supplier would be required if active ingredients or such packaging materials were no longer available from the specified supplier. The need to qualify a new supplier could delay our development and marketing efforts. We have entered into licensing and co-development agreements with a number of parties. There is a risk that, upon expiration or termination of a third party agreement, we may not be able to renew or extend the agreement with the third party, as interests may no longer coincide. In such circumstances, we may be unable to continue to develop or market our products as planned and could be required to abandon or divest a product line. (vi) We intend to explore acquisitions and our future growth will partly depend on the completion of such transactions. If we do complete acquisitions but fail to integrate these successfully, we may have products or operations that do not yield any benefit. We intend to pursue business and product acquisitions that could complement or expand our operations. However, we may not be able to identify appropriate product acquisition candidates. If an acquisition candidate is identified, we do not know if we will be able to negotiate successfully the terms of the acquisition, finance the acquisition or integrate an acquired business or product into our existing operations. The negotiation and completion of potential acquisitions could cause diversion of management's time and resources. If we complete one or more significant acquisitions through the issuance of common shares or ADS's, holders of common shares and ADS's could suffer significant dilution of their ownership interests. (vii) If we are unable to meet the requirements of regulators in relation to a particular product, we may be unable to develop and market the product. Drug companies are required to obtain regulatory approval before manufacturing and marketing most drug products. Regulatory approval is generally based on the results of: o quality testing (chemistry, manufacturing and controls) o non-clinical testing, and o clinical testing. 23 The clinical development, manufacture, marketing and sale of pharmaceutical products are subject to extensive regulation, including separate regulation by each country in the EU, the EU itself and federal, state and local regulation in the U.S. Unanticipated legislative and other regulatory actions and developments concerning various aspects of our operations and products may restrict our ability to sell one or more of our products or to sell those products at a profit. The primary regulatory authorities which regulate our ability to manufacture and sell pharmaceutical products include the MCA in the U.K., the FDA and the DEA in the U.S. and the Health Protection Branch of the Ministry of Health in Canada. The generation of data is regulated and any generated data is susceptible to varying interpretations that could delay, limit or prevent regulatory approval. Required regulatory approvals may not be obtained in a timely manner, if at all. In addition, other regulatory requirements for any such proposed products may not be met. Even if we obtain regulatory approvals, the terms of any product approval, including labeling, may be more restrictive than desired and could affect the marketability of our products. Regulatory authorities have the power to: o revoke or suspend approvals of previously approved products, o require the recall of products that fail to meet regulatory requirements, and o close manufacturing plants that do not operate in conformity with current Good Manufacturing Practices and/or other regulatory requirements or approvals. Such delays or actions could affect our ability to manufacture and sell our products. (viii) If we are unable to complete successfully projects or clinical trials for the development of products, our products will not receive authorization for manufacture and sale. Due to the complexity of the formulation and development of pharmaceuticals, we cannot be certain that we will successfully complete the development of new products, or, if successful, that such products will be commercially viable. Before obtaining regulatory approvals for the commercial sale of each product under development, we must demonstrate through clinical and other studies that the product is of appropriate quality and is safe and effective for the claimed use. Clinical trials of any product under development may not demonstrate the quality, safety and efficacy required to result in an approvable or a marketable product. Failure to demonstrate adequately the quality, safety and efficacy of a therapeutic drug under development would delay or prevent regulatory approval of the product. In addition, regulatory authorities in Europe or the U.S. (including the U.K. MCA, the EMEA in the EU and the U.S. FDA) may require additional studies, which could result in (a) increased costs and significant development delays, or (b) termination of a project as it would no longer be economically viable. The completion rate of clinical trials is dependent upon, among other factors, obtaining adequate clinical supplies and recruiting patients. Delays in patient enrollment in clinical trials may also result in increased costs and program delays. Additional delays can occur in instances in which we share control over the planning and execution of product development with collaborative partners. We intend to continue to out-license a number of products and the clinical development of such out-licensed products would then be the responsibility of the licensee. We cannot be certain that if clinical trials are completed, either we or our collaborative partners will file for or receive required authorizations to manufacture and/or market potential products in a timely manner. (ix) If a marketed product fails to work effectively or causes adverse side effects, this could result in damage to our reputation, the withdrawal of the product and legal action against us. Our ability to sell any pharmaceutical products after the receipt of regulatory approval will depend on the acceptance of those products by physicians and patients. Unanticipated side effects or unfavorable publicity concerning any of our products generally or those of our competitors could have an adverse effect on our ability to maintain or obtain regulatory approvals or successfully market our products. Our future results of operations will also depend on continued market acceptance of our current products and the lack of substitutes that are cheaper or more effective. The testing, manufacturing, marketing and selling of pharmaceutical products entails a risk of litigation and product liability. If, in the absence of insurance, we do not have sufficient financial resources to satisfy a liability resulting from such a claim or to fund the legal defense of such a claim, we could become insolvent. Product liability insurance coverage is expensive, difficult to obtain and may not be available in the future on acceptable terms. Although we carry product liability insurance, this coverage may not be adequate. In addition, we cannot be certain that insurance coverage for present or future products will continue to be available. 24 (x) If we cannot obtain the necessary financing, we may not be able to fund our expansion and repay our debts. We anticipate that our existing capital resources, together with cash expected from operations and available from bank borrowings, should be sufficient to finance current and anticipated operations and working capital requirements for the next twelve months. However, the acquisition and licensing of products, the expansion of our sales force and any expansion or relocation of our facilities would require substantial capital resources. If adequate funds are not available, we may be unable to pursue acquisitions, or be forced to curtail in-licensing or research and development programs. To satisfy our capital requirements, we may need to raise additional funds through public and private financings, including equity financings. We may also seek additional funding through corporate collaborations and other financing arrangements. We do not know whether adequate funds will be available when needed or on terms acceptable to us. Alternatively, we may need to obtain funds through arrangements with future collaborative partners or others that may require us to relinquish rights to some or all of our technologies or product candidates. If we are successful in obtaining additional financing, the terms of the financing may have the effect of diluting the value of common shares and ADS's. (xi) A change in the value of the U.S. dollar could adversely affect our results. Changes in exchange rates, particularly those between the U.S. dollar, British pound and Canadian dollar will affect our results of operations. For the year ended December 31, 2002, approximately 21% of our revenue was earned in currencies other than U.S. dollars and approximately 47% of our expenses were in currencies other than U.S. dollars. (xii) Any decrease in the sales of ADDERALL XR, or ADDERALL could significantly reduce our revenues. In 2002, sales of ADDERALL XR and ADDERALL were $427.7 million, representing approximately 41% of our revenues. Any factors that decrease sales or reduce production of ADDERALL XR or ADDERALL would significantly reduce our revenues and earnings. These include: o issues impacting the production of ADDERALL XR and ADDERALL or our supply of amphetamine salts, o factors adversely impacting the production process at the DSM manufacturing facility, o development and marketing of competitive pharmaceuticals (including generic versions -(see details above under "Treatments for central nervous system disorders" and "Intellectual property"), o technological advances (including the introduction of competing non-scheduled ADHD treatments), o loss of patent protection or ability of competitors to challenge, circumvent or infringe our patents (see details above under "Intellectual property" and below under "Legal proceedings"), o changes in reimbursement policies of third-party payers, o government action/intervention, o marketing or pricing actions by our competitors, o public opinion towards ADHD treatments, o product liability claims, or o changes in prescription writing practices. (xiii) Any decrease in the sales of 3TC could significantly reduce our revenues and earnings. We receive a royalty on the worldwide sales of 3TC except for Canada where we have established a partnership with GSK. In 2002 our royalty income for 3TC sales was $132.5 million representing approximately 13% of our revenues. This income stream generates a larger proportion of our net income as there are minimal costs associated with this income. Any factors that decrease sales or reduce the production of 3TC by GSK could significantly reduce our revenues and earnings. These include: o development and marketing of competitive pharmaceuticals, o technological advances, o loss of patent protection or ability of competitors to challenge or circumvent patents, o government action/intervention, o marketing or pricing actions by our competitors to GSK, o public opinion towards AIDS treatments, or o product liability claims, 25 (xiv) Contracts, intellectual property patents and other agreements are used in all areas of operation of the business. These may contain conditions that do not protect our position or that we cannot comply with. Contracts form the basis of agreement in many key activities such as mergers and acquisitions, arrangements with suppliers and outsourcing, or product licensing and marketing. These contracts may contain conditions that impose duties on the parties involved or may fail to contain adequate conditions to protect our position. We may be unable to meet these conditions or may be unable to enforce other parties to comply. We may, therefore, suffer financial loss or penalty. An important part of our business strategy is to protect our products and technologies through the use of patents, proprietary technology and trademarks, to the extent available. In addition, our success depends upon the ability of our collaborators and licensors to protect their own intellectual property rights. Patents and patent applications covering a number of the technologies and processes owned or licensed to us have been granted, or are pending in various countries, including the U.S. We intend to enforce vigorously our patent rights and believe that our collaborators intend to vigorously enforce patent rights they have licensed to us. However, patent rights may not prevent other entities from developing, using or commercializing products that are similar or functionally equivalent to our products or technologies or processes for formulating or manufacturing similar or functionally equivalent products. Our patent rights may be successfully challenged in the future or laws providing such rights may be changed or withdrawn. We cannot assure you that our patents and patent applications or those of our third party manufacturers will provide valid patent protection sufficiently broad to protect our products and technology and will not be challenged, revoked, invalidated, infringed or circumvented by third parties. In the regular course of business, we are party to litigation or other proceedings relating to intellectual property rights. See detail above under "Intellectual property" and below under "Legal proceedings". Additionally, our products or the technologies or processes used to formulate or manufacture those products may now, or in the future, infringe the patent rights of third parties. It is also possible that third parties will obtain patent or other proprietary rights that might be necessary or useful for the development, manufacture or sale of our products. If third parties are the first to invent a particular product or technology, it is possible that those parties will obtain patent rights that will be sufficiently broad to prevent us or our strategic collaborators from developing, manufacturing or selling our products. We may need to obtain licenses for intellectual property rights from others to develop, manufacture and market commercially viable products. We may not be able to obtain these licenses on commercially reasonable terms, if at all. In addition, any licensed patents or proprietary rights may not be valid and enforceable. We also rely on trade secrets and other un-patented proprietary information, which we generally seek to protect by confidentiality and nondisclosure agreements with our employees, consultants, advisors and collaborators. These agreements may not effectively prevent disclosure of confidential information and may not provide us with an adequate remedy in the event of unauthorized disclosure of such information. If our employees, scientific consultants or collaborators develop inventions or processes that may be applicable to our products under development, such inventions and processes will not necessarily become our property, but may remain the property of those persons or their employers. Protracted and costly litigation could be necessary to enforce and determine the scope of our proprietary rights. Our failure to obtain or maintain patent and trade secret protection, for any reason, could allow other companies to make competing products and reduce the sales of our products. We have filed applications to register various trademarks for use in connection with pharmaceuticals and related laboratory services in the U.S. and intend to trademark new product names as new pharmaceuticals and services are developed. In addition, with respect to certain products, we rely on the trademarks of third parties. These trademarks may not afford adequate protection, or we and the third parties may not have the financial resources to enforce any rights under any of these trademarks. Our inability or the inability of these third parties to protect their trademarks because of successful third party claims to those trademarks could allow others to use our trademarks and dilute their value. (xv) Throughout our business and particularly through the sale of our products, we may become involved in litigation as a defendant. This may result in distraction of senior management, significant defense costs and payment of compensation. There has been substantial litigation in the pharmaceutical industry with respect to the manufacture, use and sale of new products that are the subject of conflicting patent rights. These lawsuits relate to the validity and infringement of patents. The expense of defending lawsuits brought against us could cause us not to defend these suits and abandon 26 the products. Our own patents may be subject to infringement by others. While we may pursue litigation in order to protect these rights, we may not be successful in these lawsuits. The risk of product liability claims, product recalls, litigation and associated adverse publicity is inherent in the testing, manufacturing, marketing and selling of pharmaceutical products. The cost of defending against such claims is expensive even when the claims are not merited. A successful product liability claim against us could require us to pay a substantial monetary award. If, in the absence of insurance, we do not have sufficient financial resources to satisfy a liability resulting from such a claim or to fund the legal defense of such a claim, we could become insolvent. Product liability insurance coverage is expensive, difficult to obtain and may not be available in the future on acceptable terms. Although we carry product liability insurance, this coverage may not be adequate. In addition, we cannot be certain that insurance coverage for present or future products will continue to be available. Moreover, an adverse judgment in a products liability suit, even if insured or eventually overturned on appeal, could generate substantial negative publicity about our products and business and inhibit or prevent commercialization of other products. Item 3 provides a summary of significant legal proceedings in which we are currently involved. (xvi) Any loss of key personnel could cause us subsequent financial loss. Our success is dependent on our ability to attract and retain highly qualified management and scientific personnel. We face intense competition for personnel from other companies, academic institutions, government entities and other organizations. We may not be able to successfully attract and retain such personnel. In general, we have agreements with some of our key scientific and management personnel for periods of one year or less. The loss of such personnel, or the inability to attract and retain the additional, highly skilled employees required for our activities, could have an adverse effect on our business. (f) Available information Shire maintains a website on the World Wide Web at www.shire.com. Shire makes available, free of charge, on its website its annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after such reports are electronically filed with, or furnished to, the SEC. Shire's reports filed with, or furnished to, the SEC are also available at the SEC's website at www.sec.gov. The information on our website is not part of or incorporated by reference in this Annual Report. 27 ITEM 2: Properties We occupied the following principal premises as at December 31, 2002:
Approximate Owned or Leased Location Use Square Footage - --------------------- -------------------------- ---------------------- --------------- Chineham, Hampshire, U.K. Office accommodation (Global Headquarters) 35,000 Owned Rockville, Maryland, USA Office accommodation, laboratories and GCMP suite 59,000 Leased (Shire Laboratories Inc.) Rockville, Maryland, USA Office accommodation (Shire Pharmaceuticals 40,000 Leased Development Inc.) Northern Kentucky, USA Distribution facility(Shire US Inc.) 50,000 Leased Newport, Kentucky, USA Office accommodation (Shire US Inc.) 87,700 Leased Owings Mills, Maryland, USA Manufacturing facility 90,000 Leased Columbia, Maryland, USA Manufacturing facility 15,000 Leased Valley Stream, New York, USA Schedule II manufacturing facility and 9,500 Leased laboratories Buffalo Grove, Illinois, USA Distribution facility (Shire US Inc.) 70,000 Owned Northborough, Massachusetts, Office accommodation, laboratories and GCMP suite 61,600 Owned USA (Shire BioChem Inc.) Laval, Quebec, Canada Office accommodation and laboratories (Shire 193,500 Owned BioChem Inc.) Laval, Quebec, Canada Vaccines production (Shire BioChem Inc.) 15,200 Leased Sainte Foy, Quebec, Canada Office accommodation, manufacturing facility and 118,000 Owned laboratories (Shire BioChem Inc.) Paris, France Office accommodation 3,600 Leased Cologne, Germany Office accommodation 3,000 Leased Madrid, Spain Office accommodation 1,400 Leased Firenze, Italy Office accommodation 2,700 Leased
We also have a representative office in Singapore and have other smaller locations both in some of the countries listed above and in several other countries around the world. 28 ITEM 3: Legal proceedings (a) General The risk of product liability claims, product recalls, litigation and associated adverse publicity is inherent in the testing, manufacturing, marketing and selling of pharmaceutical products. The cost of defending against such claims is expensive even when the claims are not merited. A successful product liability claim against us could require us to pay a substantial monetary award. If, in the absence of insurance, we do not have sufficient financial resources to satisfy a liability resulting from such a claim or to fund the legal defense of such a claim, we could become insolvent. Product liability insurance coverage is expensive, difficult to obtain and may not be available in the future on acceptable terms. Although we carry product liability insurance, this coverage may not be adequate. In addition, we cannot be certain that insurance coverage for present or future products will continue to be available. Moreover, an adverse judgment in a products liability suit, even if insured or eventually overturned on appeal, could generate substantial negative publicity about our products and business and inhibit or prevent commercialization of other products. (b) Phentermine Shire US Inc. (SUS) is a defendant in eleven lawsuits still pending in both U.S. federal and state courts which seek damages for, among other things, personal injury arising from phentermine products supplied for the treatment of obesity by SUS and several other pharmaceutical companies. SUS, formerly known as Shire Richwood Inc., has been sued as a manufacturer and distributor of phentermine, an anorectic used in the short-term treatment of obesity and one of the products addressed by the lawsuits. The suits relate to phentermine either alone or together with fenfluramine or dexenfluramine. The lawsuits generally allege the following claims: the defendants marketed phentermine and other products for the treatment of obesity and misled users about the products and dangers associated with them; the defendants failed adequately to test phentermine individually and when taken in combination with the other drugs; and the defendants knew or should have known about the negative effects of the drugs and should have informed the public about such risks and/or failed to provide appropriate warning labels. SUS has been named as a defendant in a total of 3,804 such phentermine lawsuits, in respect of which SUS has been dismissed as a defendant in 3,756 cases. Shire is awaiting the furtherance of proceedings in the remaining 37 law suits. SUS became involved with phentermine through its acquisition of certain assets of Rexar Pharmacal Corporation (Rexar) in January 1994. In addition to SUS potentially incurring liability as a result of its own production of Oby-Cap, a phentermine product, the plaintiffs may additionally seek to impose liability on SUS as successor to Rexar. SUS intends vigorously to defend all the lawsuits and pursue all available reasonable defenses. SUS denies liability on a number of grounds including lack of scientific evidence that phentermine, properly prescribed, causes the alleged side effects and that SUS did not promote phentermine for long-term combined use as part of the "fen/phen" diet. Accordingly, SUS intends to defend vigorously any and all claims made against the Group in respect of phentermine. Legal expenses to date have been paid by Eon, the supplier to SUS, or Eon's insurance carriers but such insurance is now exhausted. Eon has agreed to defend and indemnify SUS in this litigation pursuant to an agreement dated November 30, 2000 between Eon and SUS. At the present stage of litigation, Shire is unable to estimate the level of future legal costs after taking into account any available product liability insurance and enforceable indemnities. To the extent that any legal costs are not covered by insurance or available indemnities, these will be expensed as incurred. (c) ADDERALL Shire's extended release "once daily" version of ADDERALL, ADDERALL XR is covered by U.S. patent No. 6,322,819 (the '819 Patent). In January 2003 we received a Paragraph IV notice from Barr alleging that this patent is invalid and not infringed by Barr's extended release mixed amphetamine salt product which is the subject of a Barr pending ANDA application. On February 24, 2003 Shire Laboratories Inc. filed suit against Barr in the U.S. District Court for the Southern District of New York for infringement of the '819 Patent with respect to this ANDA. The Hatch-Waxman Act provides for an automatic stay of up to 30 months of FDA approval for Barr's ANDA to market its generic version of ADDERALL XR to allow the Court to resolve the patent infringement lawsuit. However, there can be no assurance that the Company will be successful in the suit. In the event that the Company does not prevail, then Barr could be in a position to market its extended release mixed amphetamine salt product upon FDA final approval of its ANDA application. This may have a material adverse impact on the Company's results and financial position . In the event that the Company does not prevail in the suit, a generic version of ADDERALL XR could not be launched before October 2004, the current expiry of the existing Hatch-Waxman exclusivity. 29 For details relating to the Company's receipt of Paragraph IV notices relating to ADDERALL, see section headed "Intellectual property " . Shire filed a Complaint against Barr on April 30, 2002 in the District Court of New Jersey. In the Complaint, Shire requested a preliminary and permanent injunction to prevent Barr from marketing a mixed amphetamine salt product in a trade dress similar to that of ADDERALL. Shire requested that Barr recall all such products and also asked for damages. An order denying the preliminary injunction was issued on August 26, 2002. Shire filed a Notice of Appeal to the United States Court of Appeals for the Third Circuit on September 16, 2002 appealing the denial of Shire's motion for a preliminary injunction. (d) Emory Shire BioChem was involved in worldwide patent disputes with Emory University (Emory) relating to lamivudine, wherein Shire BioChem opposed certain patents and patent applications of Emory and wherein Emory opposed certain patents and patent applications of Shire BioChem. Pursuant to a global Settlement Agreement, finalized in May 2002, Emory has granted Shire and GSK an exclusive license under Emory's patent rights for lamivudine. The Settlement Agreement provides for the resolution of all worldwide patent disputes between the parties relating to lamivudine and FTC, including pending opposition and revocation proceedings in Europe, South Korea and Australia. The settlement involves a small royalty payment on worldwide sales of lamivudine and a license under Shire's FTC patent rights, in consideration for the settlement of all claims against Shire and GSK relating to lamivudine. Shire BioChem was also involved in worldwide patent disputes with Emory and the University of Georgia Research Foundation (Georgia) relating to certain dioxolane nucleoside analogs. Shire BioChem opposed certain patents and patent applications of Emory and Georgia and Emory opposed a European patent of Shire BioChem. Pursuant to a global Settlement and License Agreements finalized in August 2002 by Shire BioChem, Shire, Georgia and Triangle Pharmaceuticals Inc. (Triangle), Shire will grant an exclusive royalty bearing license to Emory, sub licensable to Triangle, for certain dioxolane nucleoside analogues, including diamino purine dioxolane (DAPD). Emory, Georgia and Triangle will grant an exclusive royalty bearing license to Shire for certain dioxolane nucleosides, including SPD 756. The compounds the subject of these licenses are in development. A royalty will be payable by Shire upon commercialization of SPD 756. The Settlement and License Agreements provide for the resolution of all worldwide patent disputes relating to the licensed patents. (e) Other matters In addition, the Company is involved in claims and lawsuits in the normal course of business. It is not possible at this time to determine the ultimate outcome of any of these claims. ITEM 4: Submission of matters to a vote of security holders No matters were submitted to a vote of security holders during the fourth quarter of fiscal 2002. 30 ITEM 4A: Executive officers of the registrant Our directors and executive officers as of March 28, 2003 were as follows: Name Age Position Dr James Cavanaugh 66 Non-executive Chairman Matthew Emmens 51 Chief Executive Rolf Stahel 58 Former Chief Executive* Angus Russell 46 Group Finance Director Dr Wilson Totten 47 Group Research and Development Director Dr Barry Price 59 Senior Non-executive Director Ronald Nordmann 61 Non-executive Director Dr Francesco Bellini 55 Non-executive Director The Hon. James Andrews Grant 65 Non-executive Director Gerard Veilleux 60 Non-executive Director The brief biographical details of the Directors are as follows: Dr James Cavanaugh joined the Board on March 24, 1997 and was appointed as Non-executive Chairman with effect from May 11, 1999. Dr Cavanaugh is a General Partner of HealthCare Ventures LLC. Formerly he was President of SmithKline & French Laboratories, the U.S. pharmaceutical division of SmithKline Beecham Corporation. Prior to that, he was President of SmithKline Beecham Corporation's clinical laboratory business and, before that, President of Allergan International. Prior to his industry experience, Dr Cavanaugh served as Deputy Assistant to the President of the U.S. for Health Affairs on the White House Staff in Washington, D.C. He is Non-executive Chairman of Diversa Corporation and Vicuron, Inc. and a Non-executive Director of MedImmune Inc. Dr Cavanaugh is a member of the Remuneration Committee, the Audit Committee and the Nomination Committee. Matthew Emmens joined Shire Pharmaceuticals Group plc as Chief Executive and member of the Board on March 12, 2003. Mr Emmens, 51, began his career in international pharmaceuticals in 1974 when he joined Merck & Co. He held a wide range of sales, marketing and training positions with Merck & Co before moving to help establish Astra Merck, the joint venture with Astra Pharmaceuticals. He later became its president and chief executive. Astra Merck Inc. became an independent, top 20 U.S. pharmaceutical company with annualized sales in excess of $4 billion and 4000 employees. In 1999 he joined Merck KGaA and established EMD Pharmaceuticals, the company's U.S. prescription pharmaceutical business. Until Mr Emmens joined Shire, he was based in Darmstadt, Germany as president of Merck's global prescription pharmaceuticals business, which in the year 2002 achieved sales of U.S. $2 billion. Mr Emmens graduated from Fairleigh Dickenson University in Rutherford, New Jersey, U.S., with a BS in Business Administration. Mr Emmens is a member of the Executive Committee. *Rolf Stahel joined Shire in March 1994 as Chief Executive from Wellcome plc where he worked for 27 years in Switzerland, Italy, Thailand, Singapore and the U.K. As Regional Director based in Singapore, Mr Stahel was responsible for 18 Pacific Rim countries. From April 1990 until February 1994, he served as Director of Group Marketing reporting to the Chief Executive. A business studies graduate of KSL Lucerne, Switzerland, he attended the 97th Advanced Managers Program at Harvard Business School. Mr Stahel received the Chief Executive Officer of the Year Award 2001 for the global pharmaceutical industry. In March 2003, Mr Stahel stepped down as Chief Executive and as a director of the Company. Angus Russell joined Shire on December 13, 1999 as Group Finance Director. Mr Russell worked for ICI, Zeneca and AstraZeneca for a total of 19 years. His last position was Vice President - Corporate Finance at AstraZeneca plc, where he was responsible for financial input into mergers and acquisitions activities, management of tax, legal and finance structure, investor relations activities and the management of various financial risks. Prior to this, he held a number of positions within Zeneca Group plc from 1993 until 1999, including Group Treasurer, and before that in ICI from 1980 until 1992. Mr Russell is a chartered accountant, having qualified with Coopers & Lybrand and is a fellow of the Association of Corporate Treasurers. Mr Russell is a member of the Executive Committee. 31 Dr Wilson Totten joined Shire in January 1998 as Group Research and Development Director. Dr Totten is a medical doctor and has wide experience in the pharmaceutical industry covering all phases of drug development. He has substantial experience in the field of central nervous system disorders. His last position was Vice President of Clinical Research and Development with Astra Charnwood where he served from 1995 to 1997, having previously worked for Fisons Pharmaceuticals from 1989 to 1995, and prior to that with 3M Health Care and Eli Lilly. Dr Totten is a member of the Executive Committee. Dr Barry Price joined the Board on January 24, 1996 having spent 28 years with Glaxo holding a succession of key executive positions with Glaxo Group Research. He is Chairman of Antisoma plc and also Biowisdom Ltd. He is also on the board of directors of Pharmgene plc. Dr Price is Chairman of the Remuneration Committee, and a member of both the Audit Committee and the Nomination Committee. Ronald Nordmann joined the Board of Shire on December 23, 1999 as a Non-executive Director. He was formerly a Director of Roberts Pharmaceutical Corporation since May 1999 and has been a financial analyst in healthcare securities since 1971. From September 1994 to January 2000 he was an analyst and partner at Deerfield Management. He has held senior positions with PaineWebber, Oppenheimer & Co., F. Eberstadt & Co., and Warner-Chilcott Laboratories, a division of Warner-Lambert. Mr Nordmann received his undergraduate degree from The Johns Hopkins University and an M.B.A. from Fairleigh Dickinson University. Mr Nordmann is also a Director of Guilford Pharmaceuticals Inc., Neurochem, Inc. and Pharmaceutical Resources, Inc. Mr Nordmann is acting Chairman of the Audit Committee and a member of the Nomination Committee. Dr Francesco Bellini joined the Board on May 14, 2001 as a Non-executive Director. Dr Bellini is Chairman of Picchio International Inc. and Neurochem, Inc. and is also on the board of several companies and organizations such as Molson Inc. and Industrial-Alliance Life Insurance Co. Formerly, he was Chairman and Chief Executive Officer of BioChem which he co-founded in 1986. The Hon. James Andrews Grant joined the Board on May 14, 2001 as a Non-executive Director. He was formerly a Director of BioChem since 1986, and is a partner with the law firm of Stikeman Elliot in Montreal. Mr Grant sits on the boards of two other Canadian corporations in addition to other foundations and councils that are not for profit organizations. He attended McGill University receiving a B.A. in arts in 1958 and a B.C.L in Law in 1961. Mr Grant is a member of the Nomination Committee. Gerard Veilleux joined the Board on May 14, 2001 as a Non-executive Director. He was formerly a Director of BioChem since 1999. He is president of Power Communications Inc. and Vice President of Power Corporation, a diversified management and holding company. Mr Veilleux is a director of several public and private companies as well as a member of the Board of Governors of McGill University. He has a Masters degree in public administration from Carleton University and a Batchelor of Commerce from Laval University. Mr Veilleux is a member of the Remuneration Committee. 32 PART II ITEM 5: Market for the registrant's common equity and related stockholder matters (a) Common shares Our common shares are traded on the London Stock Exchange (LSE). The following table presents the per share closing mid-market quotation for our common shares as quoted in the Daily Official List of the LSE for the periods indicated. High(pound)per Low(pound)per common share common share ------------- -------------- Year ended December 31, 2002 1st Quarter 8.86 4.84 2nd Quarter 6.61 4.83 3rd Quarter 6.61 4.52 4th Quarter 5.52 3.73 Year ended December 31, 2001 1st Quarter 13.39 8.65 2nd Quarter 12.94 10.01 3rd Quarter 13.19 8.50 4th Quarter 11.12 8.15 The total number of record holders of common shares as of March 24, 2003 was 10,637 of which 122 were registered as U.S. holders. (b) American Depository Shares American Depository Shares (ADSs) each represent three common shares. An ADS is evidenced by an American Depository Receipt (ADR) issued by Morgan Guaranty Trust Company of New York as depository, and are quoted on the NASDAQ National Market. As of March 24, 2003, the proportion of common shares represented by ADRs was 24% of the common shares outstanding. The following table presents the high and low market quotations for ADSs quoted on the NASDAQ National Market for the periods indicated. High $ Low $ Per ADS Per ADS ------------- -------------- Year ended December 31, 2002 1st Quarter 38.50 20.36 2nd Quarter 29.63 21.20 3rd Quarter 31.06 20.90 4th Quarter 26.11 17.01 Year ended December 31, 2001 1st Quarter 59.12 35.75 2nd Quarter 56.10 41.69 3rd Quarter 57.40 34.39 4th Quarter 48.78 34.37 The number of record holders of ADSs in the U.S. as of March 24, 2003 was 420. Since certain of the ADRs are held by broker nominees, the number of record holders may not be representative of the number of beneficial owners. 33 (c) Dividend policy Historically, we have not paid any dividends. We do however review the appropriateness of paying a dividend from time to time. As a matter of English law, we may pay dividends only out of our distributable profits, which are the accumulated realized profits under U.K. GAAP of the parent company, Shire Pharmaceuticals Group plc and not the consolidated group, so far as not previously utilized by distribution or capitalization, less accumulated realized losses, so far as not previously written off in a reduction or reorganization of capital duly made. As of December 31, 2002, we had an accumulated deficit of (pound)18.5 million (approximately $29.8 million). Future dividend policy will be dependant upon our distributable profits, our financial condition, the terms of any then existing debt facilities and other relevant factors existing at that time. (d) Approval of non-audit services The Chairman of the Audit Committee of Shire pre-approves all non-audit services, including tax advisory and compliance services, provided by the Company's independent auditors, Deloitte and Touche. A process for pre-approval has been in place since July 1, 2002 and has continued through to the end of the period covered by this Annual Report. 34 ITEM 6: Selected financial data The selected consolidated financial data presented below as of December 31, 2002 and 2001 and for each of the three years in the period ended December 31, 2002 were derived from the audited consolidated financial statements of Shire Pharmaceutical Group plc ("Shire), included herein. The selected consolidated financial data presented below as of December 31, 2000, 1999 and 1998 and for the two years ended December 31, 1999 were derived from the audited consolidated financial statements of Shire, which are not included herein. We have restated our results for all periods, other than 2002 and 2001, presented below to combine the results of BioChem, the merger with whom was accounted for as a pooling of interests. We have also restated the results for all periods, other than 2002, presented to reflect the disposal of our OTC business, which has been accounted for as a discontinued operation. In addition, we have restated the results of 1998 to combine the results of Roberts, the merger with whom was accounted for as a pooling of interests. Certain amounts reported in previous years have been reclassified to conform to the 2002 presentation. The selected consolidated financial data should be read in conjunction with "Item 7: Management's discussion and analysis of financial condition and results of operations" and with our consolidated financial statements and related notes appearing elsewhere in this report.
Year ended December 31, 2002 2001 2000 1999 1998 $'000 $'000 $'000 $'000 $'000 ---------- ---------- ---------- ---------- ---------- Statement of Operations: Revenues 1,037,298 852,956 647,654 515,447 410,969 Operating expenses (710,260) (709,848) (507,379) (559,911) (341,189) ---------- ---------- ---------- ---------- ---------- Operating income/(loss) 327,038 143,108 140,275 (44,464) 69,780 Interest and other, net 2,022 (41,581) 111,842 23,064 14,092 ---------- ---------- ---------- ---------- ---------- Income/(loss) before income taxes, extraordinary items and discontinued operations 329,060 101,527 252,117 (21,400) 83,872 Income taxes (88,350) (68,897) (43,564) (18,695) (4,682) Equity method investees 1,668 1,985 (3,809) - - ---------- ---------- ---------- ---------- ---------- Income/(loss) from continuing operations and before extraordinary items 242,378 34,615 204,744 (40,095) 79,190 Extraordinary items, net of tax - (2,604) - - - ---------- ---------- ---------- ---------- ---------- Income/(loss) from continuing operations 242,378 32,011 204,744 (40,095) 79,190 Income/(loss) from discontinued operations, net of tax 6,108 6,748 6,983 (7,337) 2,850 Gain on disposition of discontinued operations, net of tax 2,083 - - - ---------- ---------- ---------- ---------- ---------- Net income/(loss) 250,569 38,759 211,727 (47,432) 82,040 ---------- ---------- ---------- ---------- ----------
35 ITEM 6: Selected financial data (continued)
Year ended December 31, 2002 2001 2000 1999 1998 $'000 $'000 $'000 $'000 $'000 ---------- ---------- ---------- ---------- ---------- Earnings/(loss) per share - basic Income from continuing operations before extraordinary items 48.4c 7.0c 42.4c (8.3)c 15.0c Income from discontinued operations 1.6c 1.4c 1.4c (1.5)c 2.1c Extraordinary items, net of tax - (0.5)c - - - ---------- ---------- ---------- ---------- ---------- 50.0c 7.9c 43.8c (9.8)c 17.1c ---------- ---------- ---------- ---------- ---------- Earnings/(loss) per share - diluted Income from continuing operations before extraordinary items 47.4c 6.9c 41.4c (8.3)c 14.6c Income from discontinued operations 1.6c 1.3c 1.4c (1.5)c 2.0c Extraordinary items, net of tax - (0.5)c - - - ---------- ---------- ---------- ---------- ---------- 49.0c 7.7c 42.8c (9.8)c 16.6c ---------- ---------- ---------- ---------- ---------- Weighted average number of shares: Basic 500,687,594 492,594,226 482,890,070 484,358,876 480,827,784 Diluted 522,418,246 504,875,587 494,691,805 484,358,876 494,149,715 ---------- ---------- ---------- ---------- ----------
As a consequence of the adoption of SFAS No. 142 with effect from January 1, 2002, the amortization expense shown for 2002 in the selected consolidated financial data presented below is not on a consistent basis of accounting with earlier periods. The impact of this is shown in Note 12 of our consolidated financial statements included herein.
December 31, 2002 2001 2000 1999 1998 $'000 $'000 $'000 $'000 $'000 ---------- ---------- ---------- ---------- ---------- Balance Sheet: Total current assets 1,467,096 1,140,555 695,853 520,023 445,972 Total assets 2,208,623 1,910,731 1,548,495 1,351,791 1,210,153 Total current liabilities 213,271 231,616 227,850 233,818 99,770 Total liabilities 635,457 647,742 374,109 471,905 236,921 Total shareholders' equity 1,573,166 1,262,989 1,174,386 879,886 973,232 ---------- ---------- ---------- ---------- ----------
36 ITEM 7: Management's discussion and analysis of financial condition and results of operations We have restated our results for all periods, other than 2002 and 2001, discussed below to combine the results of BioChem, the merger with whom was accounted for as a pooling of interests. The results for all periods, other than 2002, disclosed below have also been restated to reflect the disposal of our OTC business which has been accounted for as a discontinued operation. The following discussion should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this report. (a) Results of operations for the years ended December 31, 2002 and 2001 (i) Overview For the year ended December 31, 2002, our total revenues increased by 22% to $1,037.3 million, compared to $853.0 million in fiscal 2001. Net income for the year ended December 31, 2002 was $250.6 million compared to $38.8 million in 2001, an increase of 546%. However, as net income in the year ended December 31, 2001 included $121.2 million of other charges comprising asset impairment and restructuring costs ($29.6 million), merger related transaction expenses ($83.5 million) and a loss from the sale of our manufacturing facility in Toronto, Canada ($8.1 million), this growth rate appears much higher than that attributed to our ongoing operating activities. (ii) Total revenues Our revenues are primarily derived from sales of our pharmaceutical products and royalties earned on products we have out-licensed to third parties to market on our behalf. The following table provides an analysis of our total revenues by source: Year ended December 31, 2002 2001 Change $m $m % -------- -------- -------- Product sales 859.4 699.4 + 23% Licensing and development 3.1 5.5 - 44% Royalties 174.8 145.2 + 20% Other - 2.9 - -------- -------- -------- Total 1,037.3 853.0 + 22% -------- -------- -------- (iii) Product sales For the year ended December 31, 2002, our product sales increased by 23% to $859.4 million, compared to $699.4 million in the prior year. The following table provides an analysis of our key product sales: Year ended December 31, 2002 2001 Change $m $m % -------- -------- -------- ADDERALL XR 317.9 32.6 +874% ADDERALL 109.8 317.7 -65% AGRYLIN 119.2 85.5 +39% PENTASA 87.2 75.5 +15% PROAMATINE 50.9 38.0 +34% CARBATROL 45.3 36.8 +23% CALCICHEW range 23.2 20.9 +11% Others 105.9 92.4 +15% -------- -------- -------- Total 859.4 699.4 +23% -------- -------- -------- 37 The following discussion includes references to prescription and market share data for our key products. The source of this data is IMS December 2002. ADDERALL franchise At the outset, 2002 was to be a challenging year for our ADDERALL franchise, as we expected to face strong competition from generic products. In mid February 2002, Barr Laboratories Inc. announced FDA approval to market a generic version of ADDERALL. We had launched a new patent protected, once daily, formulation of ADDERALL, called ADDERALL XR, in the U.S. on November 5, 2001. Thus, our challenge for 2002 was to continue converting patients from our twice/three times daily ADDERALL product to the new patent protected formulation. For the year ended December 31, 2002, sales of ADDERALL XR were $317.9 million compared to $32.6 million in the last two months of 2001 (the year of launch). Sales of ADDERALL for the year ended December 31, 2002 were $109.8 million compared to $317.7 million in the comparative period. This decline in ADDERALL sales is largely due to our success in converting patients to the new patent protected, once daily formulation of the drug. In addition, we have lost some ADDERALL sales to generic competitors who launched their competing products from the middle of February 2002. According to IMS data, total dollar sales from generic versions of ADDERALL were $127.2 million in 2002. On a combined basis, product sales from the ADDERALL franchise in 2002 were up $77.4 million, a 22% increase compared to the prior year. Over the same period, the number of prescriptions written for the two products was marginally higher than the prior year, up 0.6%. This demonstrates that although our share of the U.S. ADHD prescription market in December 2002 was 28.8%, versus 34.4% in December 2001, the total ADHD market is growing strongly in dollar terms, 32% during 2002. ADDERALL XR is sold at a higher price than ADDERALL, and this has had a favorable impact on our sales revenue in 2002. In addition, a lower Medicaid utilization and rebate payments on ADDERALL XR sales have also had a positive effect on our 2002 net sales, which we estimate to be between $25 million and $30 million. $17.4 million of ADDERALL XR shipments were not recognized as revenue in 2001 as, following the guidelines of Staff Accounting Bulletin No. 101, we did not consider these sales to be realized and earned in that fiscal accounting period due to the extended credit terms we offered as an incentive to wholesalers on the initial launch stock. These sales were recognized in the first quarter of 2002. There have been no such terms offered on any of our products within the year ended December 31, 2002. AGRYLIN Total AGRYLIN sales for 2002 were $119.2 million, an increase of 39% compared to the prior year (2001: $85.5 million). Underlying prescriptions for AGRYLIN in the US, where it is the only product licensed for the treatment of essential thrombocythaemia, increased by 22%, supported by a price increase in January 2002. Shire achieved 26.5% of the total US AGRYLIN, Hydrea and generic hydroxyurea prescription market in December 2002, compared to 24.4% in December 2001. PENTASA For the year ended December 31, 2002 sales of PENTASA, a treatment for ulcerative colitis, were up 15% at $87.2 million (2001: $75.5 million). Over the same period, PENTASA benefited from modest prescription growth of 4%, which reflects limited physician promotions during 2002. PENTASA sales benefited from two factory price increases during 2002, a 9% rise in January 2002 and a further 7% increase in May 2002. PENTASA had a prescription share of 17.6% of the U.S. oral mesalamine/olsalazine market in December 2002, compared with 18.6% in December 2001. PROAMATINE Sales of PROAMATINE, for the treatment of orthostatic hypotension, were $50.9 million, 34% higher than 2001 sales of $38.0 million. Underlying prescriptions grew by 15% during the year ended December 31, 2002. Approximately 11% of the reported sales growth is attributable to price increases. PROAMATINE sales also benefited from the launch of a new 10 mg strength during 2002. PROAMATINE had a 25.3% share of the U.S. prescription market for PROAMATINE and fludrocortisone acetate prescriptions in December 2002, an increase from 23.6% in December 2001. 38 CARBATROL Sales of CARBATROL, for the treatment of epilepsy, were $45.3 million in 2002, an increase of 23% over prior year sales of $36.8 million. Over the same period, underlying prescriptions grew by 7%. CARBATROL was launched in the U.S. in June 1998, and in the three years following launch the growth rate for this product has typically been much higher than the 23% achieved in 2002. We have experienced supply constraints throughout 2002 but these have now been addressed. The acquisition of the APS manufacturing facility will allow us to shift production of CARBATROL in-house. We intend to promote CARBATROL more actively during 2003. In fact, we re-launched CARBATROL in the U.S. during January 2003. CARBATROL achieved 36.3% of the U.S. extended release carbamazepine prescription market in December 2002, compared with 35.5% in December 2001. The following table presents our product sales by operating segment: Year ended December 31, 2002 2001 Change $m $m % -------- -------- -------- U.S. 714.7 587.5 + 22% International 144.7 111.9 + 29% -------- -------- -------- Total 859.4 699.4 + 23% -------- -------- -------- Product sales in the U.S. continue to represent a significant percentage of our worldwide sales, 83% in 2002 versus 84% in 2001. The growth in U.S. sales is 22% for 2002, which is lower than the 50% seen for the previous year. The main driver of this change was the slow down in growth within the U.S. ADDERALL franchise which, as explained above, was affected by product launches by generic competitors. Sales growth in our International business was 29% in 2002, compared to 6% in the prior year. There have been several new product launches in this sector during 2002, including SOLARAZE and the continued roll-out of ADEPT. The CALCICHEW range of products for the treatment of osteoporosis, continue to perform well and delivered sales growth of 11% in 2002. (iv) Licensing and development Our licensing and development income decreased by $2.4 million to $3.1 million for the year to December 31, 2002. This was mainly due to a decrease in Shire Laboratories' drug delivery contract revenue and the fact that 2001 revenues included license fee income of $1.0 million in respect of galantamine from Johnson & Johnson. Now that we have our own sales and marketing capabilities in seven of the major world pharmaceutical markets, it is less likely that we will seek third parties to market our own products on our behalf and thus, revenues from out-licensing activities is minimal. We continue to carry out some contract development work for third parties in the field of advanced drug delivery. 39 (v) Royalties Royalty revenue increased 20% to $174.8 million for the year ended December 31, 2002 compared to $145.2 million in 2001. The following table provides an analysis of our royalty income: Year ended December 31, 2002 2001 Change $m $m % -------- -------- -------- 3TC 132.5 120.1 +10% ZEFFIX 21.2 16.9 +25% Others 21.1 8.2 +160% -------- -------- -------- Total 174.8 145.2 +20% -------- -------- -------- For the products 3TC and ZEFFIX, we receive royalties from GSK on the worldwide sales, with the exception of Canada, where a partnership with GSK has been established. In 2002, worldwide sales of 3TC amounted to $982.3 million, an increase of 9% compared to sales of $902.0 million in 2001. These amounts include the 3TC sales portion in COMBIVIR, a product that combines in a single tablet two antiretroviral drugs, AZT and 3TC. 3TC sales also included the 3TC portion in TRIZIVIR, a product that combines in a single tablet three antiretroviral drugs, AZT, 3TC and Ziagen. Sales of ZEFFIX, our discovery for the treatment of chronic hepatitis B, contributed to the increase in royalty revenue in 2002. Sales of ZEFFIX totaled $185.6 million in 2002 compared to $149.0 million in 2001, an increase of 25%. Other royalties are received in respect of REMINYL from Johnson & Johnson, and in addition a number of hormone replacement therapy (HRT) products from various licensees. The 160% growth rate shown above is largely due to REMINYL royalties. (vi) Cost of product sales For the year ended December 31, 2002 our cost of product sales amounted to 16% of product sales, a ratio consistent with 2001. A slight favorable mix of the higher margin products was mainly used to offset costs associated with enhancing internal and external production facility capabilities. The production of ADDERALL was relocated from our Valley Stream facility to DSM Pharmaceuticals during 2002. We have a coordinated initiative to further upgrade manufacturing capacity and to rationalize our non-strategic manufacturing facilities within North America. (vii) Research and development expenses Research and development expenditure increased to $189.2 million in 2002 from $171.0 million in 2001, representing an increase of 11%. Included within research and development in 2001 is a warrant compensation charge of $4.5 million, relating to warrants issued to the Canadian government under the TPC contract. Excluding the effect of this warrant compensation charge, research and development expenditure increased by 14% and as a proportion of total revenues represented 18% (2001:20%). Generally, we aim to invest between 18% and 20% of our total revenues in research and development projects, but the level of expenditure required each year is largely dictated by the development phase of existing and newly in-licensed projects. For example, the proportion of research and development spend required on FOSRENOL was much higher in 2001 when clinical trials were underway. (viii) Selling, general and administrative expenses Selling, general and administrative expenses increased from $303.5 million in 2001 to $386.0 million in 2002, an increase of 27%. As a percentage of product sales, these expenses were 45% (2001: 43%). Higher selling, general, and administrative expenses were primarily due to increased selling and marketing expenses supporting higher field headcount and promotional efforts for recent product launches, including but not limited to, ADDERALL XR. 40 A component of selling, general and administrative expenses is depreciation and amortization, which decreased from $45.8 million in 2001 to $36.4 million in 2002. For 2002, amortization expense consists of a charge of $23.5 million for the year in respect of intellectual property rights. In addition, there was a write-down, totaling $18.8m, of certain intangible assets following a periodic impairment review. The charge for the year has decreased because goodwill is no longer amortized in accordance with SFAS No. 142. The depreciation charge for 2002 was $12.9 million, a decrease of $1.5 million compared to 2001. This reduction is primarily the result of the sale of our Canadian manufacturing facility part way through 2001. (ix) Other charges Other charges to operations for the year ended December 31, 2002 were $1.4 million, which were in respect of losses on the disposition of assets, primarily equipment disposed of during office relocations. For the year ended December 31, 2001, other charges amounted to $123.3 million, of which $121.2 million was in connection with the BioChem merger comprising asset impairments and restructuring charges ($29.6 million), merger transaction expenses ($83.5 million) and losses on disposal of assets ($8.1 million). In addition, $56.0 million of the asset impairment charges were in respect of investments, and are shown in other expenses within the statement of operations. The Company also incurred a loss of $2.1 million on the disposition of non-strategic products during 2001. (x) Interest income and expense In the year ended December 31, 2002, we received interest income of $19.5 million compared with $19.7 million in 2001. Interest expense increased from $8.3 million in 2001 to $9.3 million in 2002. This increase reflects a full twelve months of interest expense in relation to the $400 million convertible notes, which we issued in August 2001. The notes bear interest at a fixed rate of 2% per annum. (xi) Other (expense)/income, net For the year ended December 31, 2002, other (expense)/income, net totaled $8.3 million. The main components were a $2.3 million mark to market loss recorded on the SERP fund, $8.7 million in respect of write-downs of non-current investments due to other than temporary impairments and $3.3 million income from the management of GeneChem funds. (xii) Income taxes for continuing operations For the year ended December 31, 2002 income taxes increased by 28% to $88.4 million (2001: $68.9 million). Our effective tax rate was 27% for the year ended December 31, 2002 (2001: 25% before stock compensation and merger costs). As of December 31, 2002 we had net deferred tax assets of $41.1 million (December 31, 2001: $39.7 million). Realization is dependent upon generating sufficient taxable income to utilize such assets. Although realization of these assets is not assured, we believe it is more likely than not that the deferred tax assets will be realized. See note 26 to the consolidated financial statements for expiry dates of these tax losses. (xiii) Equity method investees Income from equity method investees for the year ended December 31, 2002 was $1.7 (2001: $2.0 million). We received $2.6 million representing our 50% share of earnings from our commercialization partnership with GSK and we incurred a loss of $0.9 million representing our 50% share of the losses of our commercialization partnership with Qualia Computing Inc. Income from equity method investees for the year ended December 31, 2001, related solely to our 50% share of earnings from our commercialization partnership with GSK. (xiv) Extraordinary items There were no extraordinary items in respect of the year ended December 31, 2002. In the previous year we incurred a $2.6 million charge relating to the write-off of deferred financial charges on a term loan repaid as a result of our merger with BioChem. (xv) Discontinued operations Discontinued operations are in respect of our U.S. "Over-The-Counter" (OTC) business which was sold in December 2002. 41 The OTC products were acquired as part of our merger with Roberts in 1999 and consisted of non-prescription laxatives and dietary supplements. Our main strategic focus is on innovative prescription pharmaceuticals prescribed by specialty doctors. Sales generated by the OTC products represented approximately 2.8% of our total product sales in 2002 and 3.5% of our total sales in 2001. Further details of this transaction are disclosed in note 5 to the consolidated financial statements. (b) Results of operations for the years ended December 31, 2001 and 2000 (i) Overview For the year ended December 31, 2001, total revenue increased by 32% to $853.0 million, compared to $647.7 million in fiscal 2000. This increase was primarily the result of an increase in product sales. Net income for the year ended December 31, 2001 was $38.8 million compared to $211.7 million in 2000. Following our merger with BioChem, the 2001 results include $121.2 million of other charges comprising asset impairment and restructuring costs ($29.6 million), merger related transaction expenses ($83.5 million) and a loss from the sale of our manufacturing facility in Toronto, Canada ($8.1 million). Net income in the year ended December 31, 2000 included income of $104.0 million related to a gain recognized on the disposal of our non-strategic long-term investment in North American Vaccine, Inc. (NAVA). (ii) Total revenues The following table provides an analysis of our total revenues by source: Year ended December 31, 2001 2000 Change $m $m % ------- ------- ------- Product sales 699.4 496.8 + 41% Licensing and development 5.5 14.1 - 61% Royalties 145.2 135.5 + 7% Other 2.9 1.3 + 123% ------- ------- ------- Total 853.0 647.7 + 32% ------- ------- ------- (iii) Product sales For the year ended December 31, 2001, our product sales increased by 41% to $699.4 million, compared to $496.8 million in the prior year. The following table provides an analysis of our key product sales: Year ended December 31, 2001 2000 Change $m $m % -------- -------- -------- ADDERALL XR 32.6 - N/a ADDERALL 317.7 213.9 +48% AGRYLIN 85.5 57.7 +48% PENTASA 75.5 54.2 +39% PROAMATINE 38.0 23.7 +60% CARBATROL 36.8 25.6 +44% CALCICHEW range 20.9 16.3 +28% Others 92.4 105.4 -12% -------- -------- -------- Total 699.4 496.8 +41% -------- -------- -------- 42 The following discussion includes references to prescription and market share data for our key products. The source of this data is IMS December 2001. ADDERALL franchise We launched a new improved, patent protected, once daily formulation of ADDERALL, called ADDERALL XR in the U.S. on November 5, 2001. ADDERALL XR on February 21, 2002, just 16 weeks from launch date, had achieved a 14% share of the U.S. ADHD prescription market. ADDERALL XR exceeded all previous records for launching a new product in this therapeutic area. By February 21, 2002, the total ADDERALL franchise had achieved a 37% market share, an increase of 5 percentage points since the launch of ADDERALL XR. For the year ended December 31, 2001, sales of ADDERALL were $317.7 million, representing 48% growth over the prior year. ADDERALL XR, in the period from launch date to December 31, 2001, achieved sales of $32.6 million including $11 million of launch stock. On a combined basis, these products delivered sales growth of 64% and achieved a 34.4% share of the prescription market for ADHD in the U.S. in December 2001 (December 2000: 33.0%). AGRYLIN Sales of AGRYLIN, the only U.S. product licensed for the treatment of thrombocythemia, grew by 48% to $85.5 million (2000: $57.7 million). We achieved 24.4% of the total U.S. AGRYLIN, Hydrea and generic hydroxyurea prescription market in December 2001, compared to 18.8% in December 2000. PENTASA Sales of PENTASA, for the treatment of ulcerative colitis, were up 39% at $75.5 million (2000: $54.2 million), due in part to price increases and also the renegotiation of our contracts with Managed Care during the past twelve months. Underlying prescriptions grew by 9% for the year 2001. PENTASA had a scrip share of 18.6% of the U.S. oral mesalamine/olsalazine market in December 2001, compared with 18.0% in December 2000. PROAMATINE Sales of PROAMATINE, for the treatment of orthostatic hypotension, were $38.0 million, 60% higher than 2000 sales of $23.7 million, due in part to price increases and also the renegotiation of our contracts with Managed Care during the year. Underlying prescriptions grew by 18% during the year ended December 31, 2001. The U.S. prescription market for PROAMATINE and Floudrocortisone presciptions showed that PROAMATINE had a 23.6% share for the month of December 2001, an increase from 21.7% in December 2000. CARBATROL CARBATROL, containing carbamazepine for the treatment of epilepsy, recorded sales of $36.8 million in 2001, an increase of 44% over prior year sales of $25.6 million. CARBATROL achieved 35.5% of the U.S. extended release carbamazepine prescription market in December 2001, compared with 30.9% in December 2000. The following table presents our net product sales by operating segment: Year ended December 31, 2001 2000 Change $m $m % ------- ------- ------- U.S. 587.5 391.2 + 50% International 111.9 105.6 + 6% ------- ------- ------- Total product sales 699.4 496.8 + 41% ------- ------- ------- Product sales in the U.S. represented a significant percentage of our worldwide sales, increasing to 84% in 2001 from 79% in 2000. The main driver of the 50% growth in revenue for this operating segment was the ADDERALL franchise. (iv) Licensing and development As expected, following the launch by Janssen of REMINYL, Shire's Alzheimer's drug, re-imbursement of associated research and development costs by Janssen came to an end. Consequently, our licensing and development income decreased by 61% to $5.5 million (2000: $14.1 million). 43 (v) Royalties Royalty revenue increased 7% to $145.2 million in 2001 compared to $135.5 million in 2000. We receive royalties from GSK on the worldwide sales of 3TC and ZEFFIX, with the exception of Canada, where a partnership has been established with GSK. In 2001, worldwide sales of 3TC amounted to $902.0 million, an increase of 4% compared to sales of $863.5 million in 2000. These amounts include the 3TC sales portion in COMBIVIR, a product that combines in a single tablet two antiretroviral drugs, AZT and 3TC. 3TC sales also included the 3TC portion in TRIZIVIR, a product that combines in a single tablet three antiretroviral drugs, AZT, 3TC and Ziagen. Sales of ZEFFIX, our discovery for the treatment of chronic hepatitis B, contributed to the increase in royalty revenue in 2001. Sales of ZEFFIX totaled $149.0 million in 2001 compared to $106.9 million in 2000, an increase of 39%. More than 80% of ZEFFIX sales were in the Asia Pacific region for both periods. (vi) Cost of product sales For the year ended December 31, 2001 cost of product sales amounted to 16% of product sales as compared to 19% in 2000. The higher margin products, ADDERALL XR, ADDERALL, PENTASA and AGRYLIN represented a higher proportion of total sales in 2001 (73%) compared to the prior year (66% of total sales). Improved pricing in respect of our ADHD franchise has also benefited the gross margin. (vii) Research and development expenses Research and development expenditure increased to $171.0 million in 2001 from $155.1 million in 2000, representing an increase of 10%. Included within research and development in 2001 is a warrant compensation charge of $4.5 million (2000: $nil). Excluding the effect of this warrant compensation charge, research and development expenditure increased by 7% and as a proportion of total revenues represented 20% (2000: 24%). (viii) Selling, general and administrative expenses Selling, general and administrative expenses increased from $230.2 million to $303.5 million, an increase of 32%. Excluding the effects of stock option compensation charges of $2.3 million (2000: $21.9 million), selling, general and administrative costs increased by 45% to $301.2 million (2000: $208.3 million). As a percentage of product sales, selling, general and administrative expenses (excluding stock option compensation charges) were 43% (2000: 42%). The increase is in part due to the increased level of promotional spend associated with the ADDERALL XR launch. A significant component of selling, general and administrative expenses are depreciation and amortization charges, which increased from $38.0 million in 2000 to $45.8 million in 2001 This increase is partly attributable to the purchase of several new products in Europe during 2001. (ix) Other charges For the year ended December 31, 2001, other charges amounted to $123.3 million, of which $121.2 million was in connection with the BioChem merger comprising asset impairments and restructuring charges ($29.6 million), merger transaction expenses ($83.5 million) and losses on disposal of assets ($8.1 million). In addition, $56.0 million of the asset impairment charges were in respect of investments, and are shown in other (expense)/income, net within the statement of operations. The Company also incurred a loss of $2.1 million on the disposition of non-strategic products during 2001. (x) Interest income and expense In the year ended December 31, 2001, we received interest income of $19.7 million compared with $19.2 million in 2000. Interest expense decreased from $16.4 million in 2000 to $8.3 million in 2001. This decrease reflects the changes in our debt profile. We repaid an $80.0 million promissory note and a $125 million term loan in full in January and May of 2001 respectively. The interest expense in respect of the $400 million convertible notes, which we issued in August 2001, accrued at a comparatively lower fixed rate of 2%. 44 (xi) Other (expense)/income, net Other income, net for the year ended December 31, 2001 was a charge of $52.9 million (2000: income of $109.0 million). Included in other income for the year ended December 31, 2001 is income of $4.0 million in respect of investments in two venture capital funds, the GeneChem Technologies Venture Fund L.P. and the GeneChem Therapeutics Venture Fund L.P and a charge of $56.0 million in respect of asset impairments. The main components of other income in the year ended December 31, 2000 was a $104.0 million gain resulting from the sale of long-term investments, primarily in respect of North American Vaccine, Inc., a publicly traded biotechnology company listed on the American Stock Exchange and $5.0 million in respect of GeneChem investment income. (xii) Income taxes For the year ended December 31, 2001 income taxes increased $25.3 million to $68.9 million from $43.6 million for the year ended December 31, 2000. Our effective tax rate before the stock compensation charge and merger costs was 25% for the year ended December 31, 2001 (2000: 17%). Net deferred tax assets at December 31, 2001 were $39.7 million. Although realization of these assets is not assured, we believe it is more likely than not that the deferred tax assets will be realized. (xiii) Equity method investees For the year ended December 31, 2001 we received $2.0 million in respect of our 50% share of the profits from our commercialization partnership with GSK. (xiv) Extraordinary items In respect of the year ended December 31, 2001, we incurred a $2.6 million charge relating to the write-off of deferred financial charges on a term loan repaid as a result of our merger with BioChem. There were no extraordinary items in respect of the year ended December 31, 2000. (xv) Discontinued operations There were no discontinued operations in respect of the years ended December 31, 2001 and 2000. Discontinued operations reflect the impact of the sale of our OTC business in December 2002. Sales generated by the OTC products represented 3.5% of our total sales in 2001 and 4.7% of our total sales 2000. Further details of this transaction are disclosed in note 5 to the consolidated financial statements. (c) Liquidity and capital resources We have financed our activities since inception through private and public offerings of equity securities, the issuance of loan notes and convertible loan notes, cash generated from our operational activities and the proceeds of disposals. Our funding requirements depend on a number of factors, including our product development programs, business and product acquisitions, the level of resources required for the expansion of our marketing capabilities as our product base expands, increased investment in accounts receivable and inventory which may arise as sales levels increase, competitive and technological developments, the timing and cost of obtaining required regulatory approvals for new products, and the continuing revenues generated from sales of our key products. (i) Cash funds As of December 31, 2002 we had cash, cash equivalents and marketable securities of $1,213.8 million, an increase of $371.8 million from $842.0 million at December 31, 2001. Our marketable securities consisted of money market fund balances and investment grade securities. (ii) Operating cash flow trends Our operations generated cash of $356.5 million during the 2002 fiscal year. This was as a result of net income of $250.6 million plus non-cash depreciation and amortization of $36.4 million, write-downs of assets of $27.5 million and other non-cash items totaling $0.7million, as well as an overall increase of $41.3 million in working capital items due to changes in receivables, inventories and payables. There has been a net inflow of $61.2 million in respect of accounts receivable during the year ended December 31, 2002. Accounts receivable were higher at the end of 2001 due to sales levels in the U.S. during the last two months of 2001 and receivables relating to ADDERALL XR shipments. 45 During the year ended December 31, 2002, cash generated from operations was used primarily to fund capital expenditures, including the purchase of the APS manufacturing facility for $17.0 million, the purchase of SOLARAZE for $20.1 million and various capital expenditures on property, plant and equipment. Excess cash funds of $779.7 million were invested in short-term money market investments. Our operations generated cash of $196.8 million during the 2001 fiscal year. This was as a result of net income of $38.8 million plus non-cash depreciation and amortization of $45.8 million, write-downs of assets of $87.0 million and other non-cash items totaling $20.8 million as well as an overall increase of $4.5 million in working capital items due to changes in receivables, inventories and payables. We invested $69.9 million in capital items, including long-term investments ($20.3 million), intangible assets ($36.0 million) and property, plant and equipment ($13.6 million). We also received proceeds of $11.6 million from the sale of capital items, including the sale of our manufacturing facility in Toronto, Canada. During the year ended December 31, 2001, we raised gross proceeds of $400.0 million through the issuance of convertible debt, which was reduced by $9.0 million of issuance costs, and also repaid existing loans totaling $207.8 million. We received $70.2 million of funding in respect of the exercise of employee stock options. Any excess funds were invested in short-term money market investments. (iii) Debt Our total borrowings as of December 31, 2002 were $408.2 million (December 31, 2001: $406.8 million). The main component of our borrowings is $400.0 million in guaranteed convertible notes due 2011. These were issued in August 2001 by Shire Finance Limited, a wholly owned subsidiary and bear interest at the rate of 2%. We incurred issuance costs of approximately $9.0 million in respect of these convertible notes. Further details of the terms of these convertible notes is provided below and in note 16 to the consolidated financial statements. (d) Contractual obligations As at December 31, 2002 our contractual obligations were as follows:
Payments due by period ---------------------------------------------------------------- Less than More than Contractual obligations Total 1 year 1 - 3 years 3 - 5 years 5 years $'000 $'000 $'000 $'000 $'000 - ------------------------- --------------- --------------- ------------- ------------- -------------- Long-term debt (note i) 401,880 626 401,254 - - Capital lease obligations 6,311 262 507 526 5,016 Operating leases 40,885 7,215 13,742 7,123 12,805 Purchase obligations (note ii) 43,772 28,048 14,298 1,426 - Other long-term liabilities reflected on the Balance Sheet (note iii) 14,884 - 647 4,873 9,364 --------------- --------------- ------------- ------------- -------------- 492,848 36,151 430,448 13,948 27,185 --------------- --------------- ------------- ------------- --------------
The above table does not include potential obligations that are only payable on occurrence of certain future events, the timing and quantity of which are uncertain. (i) Long term debt Our total long-term debt, excluding capital leases, as of December 31, 2002 was $401.9 million (December 31, 2001: $406.8 million). The main component was $400 million in guaranteed convertible notes due 2011. These were issued in August 2001 by Shire Finance Limited (the Issuer), a wholly owned subsidiary. The convertible notes are guaranteed by Shire and are convertible into redeemable preference shares of the Issuer which upon issuance will be immediately exchanged for either (i) Shire common shares or (ii) Shire ADSs, or (iii) at the Issuer's option, a cash amount based upon the London Stock Exchange volume-weighted average prices of common shares on the fourth through eighth business days following conversion. 46 At the choice of investors, each $1000 of nominal value notes can be converted into 49.62 Shire common shares (subject to adjustment) or 16.54 Shire ADSs (subject to adjustment) at any time up to August 21, 2011. Alternatively, investors can choose to receive repayment of the nominal principal in cash either at the maturity date of August 21, 2011 or by exercising a put option on any of the three put dates being August 21, 2004, August 21, 2006 and August 21, 2008. At the option of the Company, repayment can be made in the form of Shire common shares or ADSs. The number of common shares that a note holder would receive would be based on the notional principal of the notes divided by 95% of the London Stock Exchange volume-weighted average price of common shares on the five trading days after the Company gives notice of the exercise of its option. Such notice will be on or before the tenth business day preceding the repayment put date. On or after August 21, 2004, the Company may redeem, for cash, all or part of the notes providing the Common Share price has exceeded $26.20 (Sterling equivalent at the time) for 20 of the 30 consecutive dealing days in the period prior to redemption. The decision as to whether a note holder should exercise a put option will depend on a number of factors particularly the price of Shire stock at the put date and the likelihood of the Company's stock price exceeding the conversion threshold price. The conversion threshold price is equivalent to $20.15 or (pound)12.52 (at the closing exchange rate for 2002) for Shire common shares and $60.46 for Shire ADSs. If the price of Shire common shares at the first put date of August 21, 2004 remains at a level similar to the year end price of (pound)3.97 ($18.89 for Shire ADSs) it is quite possible that note holders will choose to exercise their put options. The Company currently has adequate resources from which it could satisfy repayment of the entire convertible debt principal of $400m. The only other long-term debt outstanding at December 31, 2002 was in respect of a Canadian federal and provincial government loan of $1.9 million (CAN$3.0 million). This facility is non-interest bearing and is repayable in annual installments of $0.6 million (CAN$1.0 million). (ii) Purchase obligations Vaccines We signed a ten-year contract with the Government of Canada in 2001 to assure a state of readiness in the case of an influenza pandemic (worldwide epidemic) and to provide influenza vaccine for all Canadian citizens in such an event. Under the contract, Shire Biologics will also supply the Government of Canada with a substantial proportion of its annual influenza vaccine requirements over the ten-year period. Subject to mutual agreement, the contract can be renewed for a further period of between one and ten years from 2011. The concept of a state of readiness against an influenza pandemic requires the development of sufficient infrastructure and capacity in Canada to provide 100% of domestic vaccine needs in the event of an influenza pandemic. Canada would require 32 million doses of single-strain (monovalent) flu vaccine within a production period of 16 weeks. We have started to expand our production capacity in order to meet this objective within a five-year period. A performance bond has been established in favor of Public Works and Government Services Canada in respect of this contract, which would become payable if contracted penalty clauses were triggered. This bond is for an amount equal to 10% of the minimum estimated contract value in any year, which is estimated to be CAN$19.2 million (approximately $12 million) for 2002/3003. We are also committed to investing $18.5 million in the construction of a new global vaccine research center in Laval, Canada. The completion of this project is planned for mid-year 2004. Under the Technology Partnerships Canada (TPC) agreement, we could be eligible for a government investment of approximately $3.5 million. GeneChem funds We have made investments in two venture capital funds. The fund managers distribute income to the partners of the funds in respect of dividends or realized gains made on sale of investments. In March 1997, we entered into an agreement to make an investment of CAN$30.0 million in the GeneChem Technologies Venture Fund L.P., a venture capital fund sponsored by our subsidiary, GeneChem Financial Corporation. This CAN$100.0 million Fund invests in advanced academic research projects and early stage private or public companies in the area of genomics and related technologies for human application. Our partners in this fund are a select group of financial investors. As of December 31, 2002, we have invested CAN$27.0 million in the GeneChem Technologies Venture Fund L.P. and we are, therefore, committed to investing a further $1.9 million (CAN$3.0 million) into this Fund. In September 2000, we entered into an agreement to invest CAN$15.0 million in the GeneChem Therapeutics Venture Fund L.P., which invests in genomics companies focusing on cancer and infectious diseases. As of December 31, 2002, we have committed to invest a further $4.3 million (CAN$6.8 million) in the GeneChem Therapeutics Venture Fund L.P. 47 EGS Healthcare fund In November 2000, we entered into an agreement to invest up to $10.0 million in various EGS healthcare funds. EGS is a private equity company that makes investments in healthcare companies that focus mainly on biotechnology and specialty pharmaceuticals. As of December 31, 2002, we have invested $5.1 million in EGS healthcare funds and we are, therefore, committed to invest a further $4.9 million into these funds. Berna Biotech In October 2002, the Company entered into a commercial agreement with Berna Biotech AG of Switzerland whereby Shire will manufacture and supply its FLUVIRAL(R) influenza vaccine to Berna Biotech for sale in international territories excluding Europe and North America. In return, Berna Biotech will manufacture and supply its hepatitis B vaccines, Hepavax Gene and Bio-Hep B and make them available for exclusive sale in Europe by Shire. The total commitment of $1.7 million relates to the sharing of certain clinical costs until 2005. Niro contingent consideration In September 2002, the Company completed its acquisition of Atlantic Pharmaceutical Services Inc. (APS) from Niro Inc. for cash consideration of $17.3 million, including $0.3 million costs of acquisition. A further $1.0 million of contingent consideration is due on the satisfactory conclusion of certain stocking issues. (iii) Other long-term liabilities reflected on the Balance Sheet This balance predominantly relates to: SERP Roberts, a company with whom the Company merged in December 1999, operated a defined SERP for certain U.S. employees, which was established in 1998. This plan was available to former employees of Roberts who met certain age and service requirements. As part of the restructuring of the Group following the Roberts merger, the SERP was closed to new members and contributions ceased being paid into the plan for existing members. As part of this arrangement, the Company paid a lump sum contribution into the plan of $18.0 million, the result of which is that the Company has no future contributions under the plan. In accordance with EITF 97-14, the asset and liability of $12.1 million and $8.4 million respectively are shown on the balance sheet within the categories "Other non-current assets" and "Other non-current liabilities". (e) Capital expenditure on property, plant and equipment Year ended December 31, 2002 Capital expenditure on property, plant and equipment in the year ended December 31, 2002 was $22.6 million. This expenditure included $5.7 million within APS post acquisition, $4.8 million on leasehold improvements at Shire U.S. and IT equipment spend of $4.0 million by Shire. Year ended December 31, 2001 In the year ended December 31, 2001 capital expenditure on property, plant and equipment was $13.6 million. This included $1.7 million of equipment related to our new head office facility occupied from March 2001. (f) Product acquisitions Year ended December 31, 2002 During the year ended December 31, 2002, we acquired exclusive rights to manufacture, distribute and sell SOLARAZE for the treatment of actinic keratosis from SkyePharma plc. In May 2002, we paid $18.9 million ((pound)12.9 million) in respect of certain European territories, followed in December 2002 by a further $1.2 million ((pound)0.7 million) in respect of the rights for Australia, New Zealand, South Africa and certain other countries in the Pacific Rim. Year ended December 31, 2001 Significant additions during the year ended December 31, 2001 included the products INDURGAN and MONOCID for which the purchase prices were $12.4 million and $11.4 million respectively. We also acquired the exclusive pan-European rights to market ADEPT for (pound)5.0 million (approximately $7.3 million), a new therapy containing Icodextrin, which reduces internal scarring following abdominal and pelvic surgery. ADEPT was developed by ML Laboratories plc, 48 which retains all rights to ADEPT for the rest of the world. During 2002, ADEPT was launched in the U.K., Italy, Germany, France, Spain, Greece, Austria, Sweden and the Republic of Ireland. (g) Business combinations and divestitures Year ended December 31, 2002 On September 27, 2002 we completed our acquisition of APS from Niro Inc. for cash consideration of $17.3 million, including the costs of acquisition. This transaction provided us with an in-house facility in which to manufacture several key U.S. products. The acquisition was accounted for using the purchase method and goodwill of $10.2 million was recorded. Further details of this acquisition are provided in note 3 to the consolidated financial statements. On December 27, 2002, we completed the divestment of a group of non-strategic U.S. products, known collectively as the `Over-The-Counter' (OTC) products. We received sale proceeds of $71.0 million and recorded a gain on disposal of $2.1 million. In addition, there are potential warranties of up to $7 million in respect of the divestment, of which the Company has provided what it deems necessary at this stage. Further details of this discontinued operation are provided in note 5 to the consolidated financial statements. Year ended December 31, 2001 Our merger with BioChem in May 2001 was achieved through a tax-free exchange of shares. This transaction was accounted for as a pooling of interests. We exchanged 0.7586 ADSs for each common share of BioChem. Merger related costs, which totaled $177.2 million, are discussed above. (h) Foreign currency fluctuations Our Group's parent company and a number of subsidiary operations are located outside the U.S. As such, the consolidated financial results are subject to fluctuations in exchange rates, particularly those between the U.S. dollar, British pound, Euro and Canadian dollar. The accumulated foreign currency translation differences are reported within accumulated other comprehensive income. (i) Concentration of credit risk Our revenues from product sales are mainly derived from agreements with major pharmaceutical companies and relationships with pharmaceutical wholesale distributors and retail pharmacy chains. Such clients typically have significant cash resources, and thus any credit risk associated with these transactions is considered minimal. We operate clearly defined credit evaluation procedures. For the year ended December 31, 2002 there were three customers in the U.S. who accounted for 55% of our total revenues. Financial instruments that potentially expose us to concentrations of credit risk consist primarily of short-term cash investments and trade accounts receivable. Excess cash is invested in short-term money market instruments, including bank and building society term deposits and commercial paper from a variety of companies with strong credit ratings. These investments typically bear minimal risk. (j) Inflation Although at reduced levels in recent years, inflation continues to apply upward pressure on the cost of goods and services which we use in our business. However, we believe that the net effect of inflation on our operations has been minimal during the past three years. (k) New accounting pronouncements In June 2001, the FASB issued SFAS No. 143, Accounting for Asset Retirement Obligations. SFAS No. 143 requires that the fair value of a liability for asset retirement obligations be recognized in the period in which it is incurred if a reasonable estimate of the fair value can be made. The associated asset retirement costs are capitalized as part of the carrying amount of the related long-lived asset. SFAS No. 143 is effective for financial statements issued for fiscal years beginning after June 15, 2002. The Company has assessed the potential impact of the adoption of SFAS No. 143 and concluded that there is no impact. In April 2002, the FASB issued SFAS No. 145, Rescission of FASB Statements No.4, 44 and 64, Amendment of FASB Statement No.13 and Technical Corrections. The principal change is that gains or losses from extinguishment of debt which are classified as extraordinary items by SFAS No. 4 will no longer be classified as such. The provisions of SFAS 49 No. 145 are effective for fiscal years beginning after May 15, 2002 although early application of the Statement related to the rescission of SFAS No. 4 is encouraged. The Company plans to adopt SFAS No. 145 for its fiscal year ending December 31, 2003. When adopted, prior extraordinary items related to the extinguishment of debt will need to be reclassified. In June 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities, which addresses accounting and processing for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force (EITF) Issue 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit and Activity (including Certain Costs Incurred in a Restructuring). SFAS No. 146 requires that a liability for a cost associated with an exit or disposal liability be recognized when the liability is incurred. Under Issue 94-3, a liability for an exit cost was recognized at the date of an entity's commitment to an exit plan. Under SFAS No. 146, fair value is the objective for initial measurement of the liability. SFAS No. 146 is effective for exit or disposal activities that are initiated after December 31, 2002, with early application encouraged. We do not expect the adoption of SFAS No. 146 to have a material impact on our financial position, results of operations or cash flows. In November 2002, the FASB issued Interpretation No. 45, Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others (FIN 45). This interpretation elaborates on the disclosures to be made by a guarantor in its interim and annual financial statements about its obligations under certain guarantees that it has issued. It also clarifies that a guarantor is required to recognize, at the inception of a guarantee, a liability for the fair value of the obligation undertaken in issuing the guarantee. The disclosure requirements of FIN 45 are effective for interim and annual periods after December 15, 2002. The initial recognition and initial measurement requirements of FIN 45 are effective prospectively for guarantees issued or modified after December 31, 2002. We are assessing, but at this point do not believe the adoption of the recognition and initial measurement requirements of FIN 45 will have a material impact on our financial position, cash flows or results of operations. In January 2003, the FASB issued Interpretation No. 46, Consolidation of Variable Interest Entities, an Interpretation of APB No. 51 (FIN 46). This interpretation requires certain variable interest entities to be consolidated by the primary beneficiary of the entity if the equity investors in the entity do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. FIN 46 is effective for all new variable interest entities created or acquired after January 31, 2003. For variable interest entities created or acquired prior to February 1, 2003, the provisions of FIN 46 must be applied for the first interim or annual period beginning after June 15, 2003. The Company does not currently believe that it will be required to consolidate or disclose any SPE on adoption of FIN 46. (l) Critical accounting policies The preparation of consolidated financial statements under generally accepted accounting principles requires us to make certain estimates and judgments that affect reported amounts of assets, liabilities, revenues, expenses and disclosures in our financial statements. Critical accounting policies are those that require the most significant, complex or subjective judgments, which are often as a result of the need to make estimates on matters that are inherently uncertain. Our critical accounting policies are those in relation to litigation, valuation of intangible assets, valuation of fixed asset investments, sales rebates and income taxes. (i) Litigation Shire accounts for litigation losses in accordance with Statement of Financial Accounting Standards (SFAS) No. 5, "Accounting for Contingencies." Under SFAS No. 5, loss contingency provisions are recorded for probable losses when management is able to reasonably estimate the loss. Where the estimated loss lies within a range and no particular amount within that range is a better estimate than any other amount the minimum amount is recorded. In other cases management's best estimate of the loss is recorded. These estimates are developed substantially earlier than the ultimate loss is known, and the estimates are refined each accounting period, in light of additional information being known. In instances where Shire is unable to develop a best estimate of loss, no litigation loss is recorded at that time. As information becomes known a loss provision is set up when a best estimate can be made. The best estimates are reviewed quarterly and the estimates are changed when expectations are revised. (ii) Valuation of Intangible Assets Shire has acquired and continues to acquire significant intangible assets that Shire records at acquisition cost. As at December 31, 2002 the carrying value of such intangibles was $301.1 million. Those assets which do not yet have a defined revenue stream and for which there are no alternative uses are expensed upon acquisition as acquired in-process research and development, and those that do have a defined revenue stream (namely commercial products or rights to products awaiting final regulatory approval) are capitalized and amortized over their estimated useful life. 50 Management's estimate of the useful life considers, interalia, the following factors: the expected use of the asset by the entity; any legal, regulatory, or contractual provisions that may limit the useful life and the effects of demand, competition, and other economic factors (such as the stability of the industry, known technological advances, legislative action that results in an uncertain or changing regulatory environment, and expected changes in distribution channels). There is a high occurrence of transactions involving the transfer of intangible assets between companies in the health care field, and valuations are usually based on a discounted cash flow analysis. Shire uses a discounted cash flow model to value intangible assets acquired and for the assessment of impairment. The discounted cash flow model requires assumptions about the timing and amount of future cash inflows and outflows, risk, the cost of capital, and terminal values. Each of these factors can significantly affect the value of the intangible asset. Shire engages independent valuation experts who review Shire's critical assumptions for significant acquisitions of intangibles. Shire reviews intangible assets for impairment periodically using an undiscounted net cash flows approach whenever events or circumstances suggest that the carrying value of the intangible asset is not recoverable. If the undiscounted cash flows of an intangible asset are less than its carrying value, the intangible asset is written down to its estimated discounted cash flow value. Where cash flows cannot be identified for an individual asset, the review is applied at the lowest group level for which cash flows are identifiable. Upon adoption of SFAS No. 142 on January 1, 2002, Shire assesses the recoverability of the carrying value of its goodwill and other intangible assets with indefinite useful lives at least annually or whenever events or changes in circumstances indicate that the carrying amount of the asset may not be fully recoverable. Recoverability of goodwill is measured at the reporting unit level based on a two-step approach. First, the carrying amount of the reporting unit is compared to the fair value as estimated by the future net discounted cash flows expected to be generated by the reporting unit. To the extent that the carrying value of the reporting unit exceeds the fair value of the reporting unit, a second step is performed, wherein the reporting unit's assets and liabilities are fair valued. The implied fair value of goodwill is calculated as the fair value of the reporting unit in excess of the fair value of all non-goodwill assets and liabilities allocated to the reporting unit. To the extent that the reporting unit's carrying value of goodwill exceeds its implied fair value, impairment exists and must be recognized. As of January 1, 2002, Shire had goodwill with a net carrying value of $175.3 million that was subject to the transition provision of SFAS No. 142. During the first half of 2002, Shire performed the required impairment tests of goodwill as of January 1, 2002 and determined that there was no impairment. A prolonged general economic downturn and, specifically, competitive pricing pressure, could create an imbalance of industry supply and demand, or otherwise diminish volumes or profits. Such events, combined with changes in interest rates, could adversely affect our estimates of future net cash flows to be generated by our long-lived assets. Consequently, it is possible that our future operating results could be materially and adversely affected by additional impairment charges related to the recoverability of our long-lived assets. (iii) Valuation of Fixed Asset Investments The Company has certain investments in equity securities. All equity investments, where Shire does not have the ability to exercise significant influence and where the equity securities are not marketable, are accounted for under the cost method. At December 31, 2002 the carrying value of investments accounted for under the cost method was $72.0 million. Under the cost method, investments in private companies are carried at cost, less provisions for other than temporary impairment in value. For public companies, the Company classifies its equity investments as available-for-sale and, accordingly, records these investments at their fair values with unrealized gains and losses included in "Accumulated other comprehensive loss", net of any related tax effect. Shire periodically reviews its fixed asset investments for other than temporary impairments whenever certain events or circumstances suggest that the carrying value of an investment exceeds the fair market value of the investment. Indicators of other than temporary impairments include: o the market value of a quoted investment being below the carrying value of the investment for an extended period; o adverse news flow for private company investments in relation to the progress of scientific technology/development of compounds; and o recent stock issuances at a price below the investment price. If the fair value appears to be below the carrying value we consider all available evidence in assessing whether there is an other than temporary impairment. This evidence would include: o positive progress in the issuer's scientific technology/ development of compounds; o ongoing activity in collaborations with the issuer; o a lack of other substantial company-specific adverse events causing a decline in value; 51 o analysis and valuation of comparable companies; and o the overall financial condition of the issuer. In instances where our review indicates that there is an other than temporary permanent impairment, Shire writes down the investment to the then fair value of the investment, recording an impairment charge in the consolidated statement of operations. The determination of the fair value of private company investments together with the determination of whether an unrealised loss is permanent requires significant judgment and can have a material impact on the reported results. (iv) Sales Rebates Sales deductions primarily consist of statutory rebates to state Medicaid agencies, contractual rebates with health-maintenance organizations (HMOs), product returns, and trade discounts. Provision for rebates are recorded as reductions to revenue in the same period as the related sales with estimates of future utilization derived from historical trends. Provisions for product returns and trade discounts to customers are recorded as reductions to revenue in the same period as the related sales with estimates based upon past activity levels and duration of time in the processing of deductions. The actual experience and the level of rebate may deviate from the estimate. Shire revises its estimates every period and may be required to adjust the estimate in a subsequent period. (v) Income Taxes Shire operates in numerous countries where its income tax returns are subject to audits and adjustments. Because Shire operates globally, the nature of the audit items are often very complex, and the objectives of the government auditors can result in a tax on the same income in more than one country. The Company employs internal and external tax professionals to minimize audit adjustment amounts where possible. The Company also has significant deferred assets due to net operating losses (NOL's) in the United States, Canada and other countries. The realization of these assets is not assured and is dependent on the generation of sufficient taxable income in the future. Management has exercised judgment in determining the extent of the realization of these losses based upon estimates of future taxable income in the various jurisdictions in which these NOL's exist. Where there is an expectation that on the balance of probabilities there will not be sufficient taxable profits to utilize these NOL's a valuation allowance has been made against these deferred tax assets. If actual events differ from management's estimates, or to the extent that these estimates are adjusted in the future, any changes to the valuation allowance could materially impact our financial position and results of operations. At December 31, 2002 the Company had gross deferred tax assets of $208.6 million and had recorded a valuation allowance of $139.5 million against this amount. 52 ITEM 7A: Quantitative and qualitative disclosures about market risk (a) Treasury policies and organization Our treasury activities are coordinated by our treasury function, based in the U.K. All treasury operations are conducted within a framework of policies and procedures approved by the Board. As a matter of policy, we do not undertake speculative transactions which would increase our currency or interest rate exposure. We are subject to market risk in the following areas: (b) Interest rate risk Due to the high proportion of fixed rate debt, the Company's interest charge has limited exposure to interest rate movements. The convertible notes bear interest of 2% per annum, payable semi-annually. This interest rate is fixed over the period of the debt, thus reducing any cash flow risk associated with movements in interest rates. The interest rate risk that has been mitigated by obtaining a fixed rate debt is equivalent to a $4.0 million saving per 1% rise in interest rates per annum. Conversely a fall in interest rates by 1% will effectively cost the Company $4.0 million. In the year ended December 31, 2002, the average interest rate received on cash and liquid investments was approximately 1.8% per annum. The largest proportion of investments was in U.S. dollar deposits. (c) Foreign exchange risk The Company is exposed to movements in foreign exchange rates against U.S. dollars for trading transactions and the translation of net assets and earnings of non U.S. subsidiaries. The main trading currencies of the Company are the U.S. dollar, the Canadian dollar, pounds sterling and the euro. The financial statements of foreign entities are translated using the accounting policies described in note 2 to the consolidated financial statements. We have a small proportion of debt denominated in foreign currencies. As at December 31, 2002, a total of $1.9 million was outstanding (December 31, 2001: $5.4 million) in respect of loans denominated in Canadian dollars. The exposure to foreign exchange risk is managed and monitored by our treasury function, using forecasts provided by the operating units. The Company has not undertaken any foreign currency hedges through the use of forward foreign exchange contracts during the year to December 31, 2002. Instead, exposures have been managed through natural hedging via the currency denomination of cash balances. (d) Market risk of investments As at December 31, 2002, the Company has $72.0 million of investments comprising equity investments funds, private companies and publicly quoted equities. These investments are exposed to market risk. No financial instruments or derivatives have been employed to hedge this risk. 53 ITEM 8: Financial statements and supplementary data The consolidated financial statements and supplementary data called for by this item are submitted as a separate section of this report. ITEM 9: Changes in and disagreements with accountants on accounting and financial disclosure On July 31, 2002, Arthur Andersen informed Shire Pharmaceuticals Group plc (the "Registrant") that it would no longer be able to serve as the Registrant's independent auditors, and submitted its letter of resignation to the Registrant which was accepted by the Registrant. The Board of Directors of the Registrant, upon the recommendation of its Audit Committee, subsequently engaged the services of Deloitte & Touche as the Registrant's new independent auditors. The change in auditors became effective July 31, 2002. The audit reports of Arthur Andersen on the consolidated financial statements of the Registrant as of and for the fiscal years ended December 31, 2001 and 2000 did not contain any adverse opinion or disclaimer of opinion, nor were they qualified or modified as to uncertainty, audit scope or accounting principles. During the Registrant's two fiscal years ended December 31, 2001, and through July 31, 2002, there were no disagreements between the Registrant and Arthur Andersen on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure which, if not resolved to Arthur Andersen's satisfaction, would have caused Arthur Andersen to make reference to the subject matter of the disagreement in connection with its reports on the Registrant's consolidated financial statements for such years. None of the reportable events described under Item 304(a)(1)(v) of Regulation S-K occurred during the Registrant's two most recent fiscal years ended December 31, 2001, or through July 31, 2002. During the Registrant's two fiscal years ended December 31, 2001, and through July 31, 2002, the Registrant did not consult Deloitte & Touche with respect to any of the matters or events set forth in Item 304(a)(2)(i) and (ii) of Regulation S-K. 54 PART III ITEM 10: Directors and executive officers of the registrant Certain information relating to our directors and executive officers is set forth in Item 4A of Part I of this Form 10-K under the caption "Executive officers of the registrant". ITEM 11: Executive compensation The following table sets forth, for 2002, 2001 and 2000, the compensation of the Executive Officers of the Company. (a) Summary compensation table
Long term Annual Compensation Compensation Awards ------------------------------ --------------------------- Value of Number of Securities All Other Name and Position Year Salary Bonus Securities Underlying options Compensation Underlying options ---- ------------ ---------- ------------- -------------- ------------ Rolf Stahel (1, 2) 2002 $840,000 $840,000 $1,486,000 123,964 $364,000 Former Chief Executive 2001 $693,000 $323,000 $1,157,000 89,096 $96,000 2000 $575,000 $316,000 $809,000 68,015 $80,000 Angus Russell (3) 2002 $436,000 $192,000 $544,000 44,838 $123,000 Group Finance Director 2001 $377,000 $162,000 $364,000 25,760 $63,000 2000 $272,000 $136,000 $174,000 14,225 $48,000 Dr Wilson Totten (4) 2002 $466,000 $212,000 $826,000 67,860 $114,000 Group Research and 2001 $414,000 $158,000 $633,000 47,466 $72,000 Development Director 2000 $303,000 $151,000 $430,000 35,136 $33,000
(1) In addition to the Chief Executive, the Company has only two other executive officers. (2) Mr Stahel's other compensation consists of Company pension contributions and other benefits provided. (3) Mr Russell's other compensation consists of Company pension contributions and other benefits provided. (4) Dr Totten's other compensation consists of Company pension contributions and other benefits provided. The following table sets forth information with respect to grants of stock options to each of the executive officers during the year ended December 31, 2002. 55 (b) Option grants in 2002
Percentage of Potential Realizable Value at Number of Total Options Assumed Rates of Stock Price Securities Granted to Exercise Appreciation for Underlying Options Employees in Price per Option Term (1) Granted Fiscal 2002 Share $ Expiration Date 5% 10% --------------- ----------- ---------- -------------- --------- ---------- Rolf Stahel(2) 209,211 3% $7.19 03.03.12 237,138 497,971 Angus Russell(2) 114,474 2% $7.19 03.03.12 129,755 272,475 (3) 1,882 * $7.80 31.05.06 8,091 19,929 Dr Wilson Totten(2) 122,368 2% $7.19 03.03.12 138,702 291,264 (3) 1,882 * $7.80 31.05.06 8,091 19,929 * Less than 1%
(1) The potential realizable value uses the hypothetical rates specified by the SEC and is not intended to forecast future appreciation, if any, of the Company's stock price. The Company did not use an alternative formula for this valuation as the Company is not aware of any formula which will determine with reasonable accuracy a present value based on future unknown or volatile factors. The Company disavows the ability of this or any other valuation model to predict or estimate the Company's future stock price or to place a reasonably accurate present value on the stock options because all models depend on assumptions about the stock's future price movements, which is unknown. The value indicated is a net amount, as the aggregate exercise price, translated at the rate of exchange at December 31, 2002, has been deducted from the final appreciated value. (2) Options were granted under the 2000 Executive Scheme. Options granted under this scheme are subject to performance criteria determined prior to the date of grant. These options have been granted based on performance criteria being satisfied before grant namely that the Company's share price has increased by an annualized compound rate of 20.5% over a minimum three-year period. The exercise price was (pound)5.065 per share and has been translated at the rate of exchange at the date of grant of $1.419 : (pound)1.00. The vesting date for these options is March 4, 2005. (3) Options were granted under the Sharesave Scheme. The vesting date for these options is December 1, 2005. The exercise price was (pound)5.02 per share and has been translated at the rate of exchange at the date of grant of $1.553 : (pound)1.00. 56 (c) Aggregated option/SAR exercises in last fiscal year and fiscal year end option/SAR values The following table sets forth information with respect to each of the executive officers concerning the value of all exercised and unexercised stock options of such individuals at December 31, 2002
Number of Securities Underlying Shares Unexercised Options Value of Unexercised In-the-Money Acquired on Value Options Exercise Realized Exercisable Unexercisable Exercisable Unexercisable ---------- ----------- ----------- ------------ ----------- ------------ Rolf Stahel 869,095 6,092,117 95,679 425,284 117,575 - Angus Russell - - - 241,991 - - Dr Wilson Totten - - 150,000 303,473 142,476 -
The value of unexercised in-the-money options is a net amount, as the aggregate exercise price, translated at the rate of exchange at December 31, 2002, has been deducted from the unexercised value. (d) Employment agreements Following a review of all executive employment contracts in 2002, various changes were approved by the remuneration committee in the summer and early autumn of 2002. The Company entered into a new employment contract with Mr Stahel on February 23, 2003 which is terminable by either party on the giving of 12 months' notice. In connection with this agreement Mr Stahel was paid a salary of $840,000 for the year ended December 31, 2002 and is entitled to a performance related "target" bonus of up to 55% of salary. The remuneration committee also has the discretion to make further awards under the bonus plan, for exceptional achievement beyond the targets set out at the beginning of the year, with a maximum annual bonus capped at 100% of salary. The Company entered into a new employment contract with Mr Russell on November 29, 2002 which is terminable by either party on the giving of 12 months' notice. In connection with such agreement Mr Russell was paid a salary of $436,000 for the year ended December 31, 2002 and is entitled to a performance related "target" bonus of up to 50% of salary. The remuneration committee also has the discretion to make further awards under the bonus plan, for exceptional achievement beyond the targets set out at the beginning of the year, with a maximum annual bonus capped at 75% of salary. The Company entered into a new employment contract with Dr Totten on December 17, 2002 which is terminable by either party on the giving of 12 months' notice. In connection with such agreement Dr Totten was paid a salary of $466,000 for the year ended December 31, 2002 and is entitled to a performance related "target" bonus of up to 50% of salary. The remuneration committee also has the discretion to make further awards under the bonus plan, for exceptional achievement beyond the targets set out at the beginning of the year, with a maximum annual bonus capped at 75% of salary. In addition to basic salary and bonus, the executive directors receive certain benefits-in-kind, principally a car or car allowance, participation in the Shire defined contribution pension plan and private medical insurance. (e) Non-executive directors' fees Our non-executive Directors receive fees on an annual basis for their services. We also reimburse non-executive Directors for out-of-pocket travel expenditures relating to their service on the Board. During the year ended December 31, 2002 our non-executive Directors received fees totaling $347,000. 57 ITEM 12: Security ownership of certain beneficial owners and management Set forth in the following table is the beneficial ownership of common shares as of March 24, 2003 for (i) each person (or group of affiliated persons) known to the Company to be the beneficial owner of more than 5% of common shares, (ii) all current Directors (iii) each of the Company's executive officers, including the Company's Chief Executive and (iv) all current Directors and executive officers as a group. Except as indicated by the notes to the following table, the holders listed below have sole voting power and investment power over the shares beneficially held by them. The address of each of the Company's Directors and executive officers is that of the Company.
Number of common shares beneficially Percent of owned as of March outstanding 24, 2003 shares Name - ------------------------------------------------------------------------ ----------------- ---------------- Franklin Resources, Inc. (including its affiliates) (2) One Franklin Parkway, San Mateo, CA 94403-1906, U.S. 67,819,145 14.01 FMR Corp. (including its affiliates) (3) 82 Devonshire Street, Boston, MA 02109-3614, U.S. 50,436,464 10.41 Dr James Cavanaugh (4) 8,806,368 1.81 Rolf Stahel (5) 751,647 * Angus Russell (6) 56,422 * Dr Wilson Totten (7) 198,056 * Dr Barry Price 31,350 * Ronald Nordmann 46,968 * Dr Francesco Bellini (8) 10,000,258 2.06 Hon James Grant (9) 158,154 * Gerard Veilleux (10) 10,003 * All Directors and Officers as a Group (9 persons) 20,059,226 4.14
* Less than 1% (1) For the purposes of this table, a person or a group of persons is deemed to have "beneficial ownership" as of a given date of any shares which that person has the right to acquire within 60 days after that date. For purposes of computing the percentage of outstanding shares held by each person or a group of persons named above on a given date, any shares which that person or persons has the right to acquire within 60 days after that date are deemed to be outstanding, but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person. (2) Based solely on information provided to the Company by Franklin Resources, Inc. (including its affiliates) on December 12, 2002. (3) Based solely on information provided to the Company by FMR Corp. and Fidelity International Limited on January 31, 2003. (4) Dr Cavanaugh is a General Partner of HealthCare Ventures LLC, which is the management company for a number of limited partnerships which have interests in 8,690,090 common shares. Dr Cavanaugh is also a general partner in these partnerships. 8,690,090 of the shares in which Dr Cavanaugh is expressed to be interested represent shares held by those partnerships and not Dr Cavanaugh personally. The remaining 116,278 shares are held by Dr Cavanaugh as beneficial owner. (5) Includes 136,107 common shares issuable upon exercise of options. (6) All of Mr Russell's shares are issuable on exercise of options. (7) Includes 191,995 common shares issuable upon exercise of options. 58 (8) Includes 3,413,550 common shares issuable upon exercise of options. (9) Includes 153,603 cmmon shares issuable upon exercise of options. (10) All of Mr Veilleux's shares are issuable on exercise of options. Set forth in the following table are the details, for the year ended December 31, 2002, in respect of compensation plans (including individual compensation arrangements) under which equity securities of the registrant are authorized for issuance.
Number of securities Number of remaining securities to be Weighted- available for issued upon average future issuance exercise of price of under equity outstanding outstanding compensation Plan category options options plans ___________ ___________ ___________ Equity compensation plans approved by security holders 20,051,297 11.55 17,342,342 ___________ ___________ ___________ Equity compensation plans not approved by security holders - - - ___________ ___________ ___________
ITEM 13: Certain relationships and related transactions Mr Spitznagel, a former Director of the Company, who resigned during the year ended December 31, 2001, entered into a consultancy agreement with the Company in December 1999, which provided that: o If he had good reason, as defined in his service agreement with Roberts, to terminate his employment with Roberts under his service agreement, the Company would cause Roberts to provide him with the payments and benefits he would be entitled to upon a `good reason' termination; o Mr Spitznagel would provide consulting services to the Company for at least 42 months following the acquisition of Roberts, unless Mr Spitznagel terminated the consultancy agreement prior to the end of the 42nd month upon 30 days notice; and o The Company would pay Mr Spitznagel at a rate of $400,000 per annum for his consulting services, $150,000 per annum as an office allowance, $250,000 per annum to comply with certain restrictive covenants contained therein and $150,000 per annum for tax, financial and estate planning advice, life insurance and health insurance. The amount owed to Mr Spitznagel at December 31, 2002 was $0.5 million (at December 31, 2001 it was $1.4 million). The Company incurred professional fees with law firms, in which the Hon James Grant is a partner, totaling $1,239 for the year ended December 31, 2002 ($1.9 million for the year ended December 31, 2001 and $0.4 million for the year ended December 31, 2000). BioChem Immunosystems Inc (Immunosystems), formerly a wholly owned subsidiary of BioChem, was sold in February 2000 to a third party. Dr Bellini, the former chief executive officer of BioChem, continued as a director of Immunosystems. In December 2001, the Company acquired a 19.9% equity interest in Immunosystems in consideration for the release of a debt owing to the Company from Immunosystems. This debt existed prior to the Company's merger with BioChem. As part of the same transaction, the Company was released from a pre-existing BioChem guarantee over other Immunosystems' liabilities. 59 ITEM 14: Controls and procedures Within the 90-day period prior to the date of this report, an evaluation was carried out, under the supervision and with the participation of our management, including our Chief Executive and our Group Finance Director, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 of the Securities Exchange Act of 1934. Based upon that evaluation, the Chief Executive and the Group Finance Director concluded that our disclosure controls and procedures are effective to ensure that information required to be disclosed by the Company in reports that it files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms. There have been no significant changes to the Company's internal controls or in other factors that could significantly affect internal controls, including any corrective actions with regard to significant deficiencies and material weaknesses. 60 PART IV ITEM 15: Exhibits, financial statement schedules and reports on Form 8-K (a) (i) Financial statements Reference is made to the Index to the consolidated financial statements and consolidated financial statement schedules hereinafter contained (see F-1). (ii) Exhibits Reference is made to the Index of exhibits herein contained (see E-1). (b) Reports on Form 8-K During the fourth quarter ended December 31, 2002, the following reports on Form 8-K were filed with the Securities and Exchange Commission: Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported October 3, 2002, with respect to the issue of a press release announcing holdings by The Capital Group Companies Inc. and its affiliates in the ordinary share capital of Shire. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported October 7, 2002, with respect to the issue of a press release announcing holdings by FMR Corp, Fidelity International Limited and their subsidiaries in the ordinary share capital of Shire. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported October 15, 2002, with respect to the issue of a press release announcing the acquisition by the Company of a new project for Ulcerative Colitis. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported October 28, 2002, with respect to the issue of a press release announcing a vaccines alliance with Berna Biotech AG of Switzerland. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported October 29, 2002, with respect to the issue of a press release announcing the results of head to head study of REMINYL(R) and Donepezil. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported October 29, 2002, with respect to the issue of a press release announcing that Chief Executive Rolf Stahel will leave Shire and its board when a successor is found. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported November 4, 2002, with respect to the issue of a press release announcing the details of research into the effect of FOSRENOL(R) in end stage renal disease. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported November 6, 2002, with respect to the issue of a press release announcing holdings by FMR Corp, Fidelity International Limited and their subsidiaries in the ordinary share capital of the Company. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported November 6, 2002, with respect to the issue of a press release announcing invitation to third quarter results presentation. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported November 6, 2002, with respect to the issue of a press release announcing the Company's results for the third quarter of 2002. 61 Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported November 14, 2002, with respect to the issue of a press release announcing holdings by Franklin Resources and its affiliates in the ordinary share capital of the Company. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported November 19, 2002, with respect to the issue of a press release announcing an application for listing of shares issued upon exchange of Shire Acquisition Inc. exchangeable shares. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported November 22, 2002, with respect to the issue of a press release announcing holdings by The Capital Group Companies Inc. and its affiliates in the ordinary share capital of the Company. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported November 26, 2002, with respect to the issue of a press release announcing an application for listing of shares upon the exercise of warrants pursuant to an agreement between Shire BioChem Inc. and the Government of Canada. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported November 27, 2002, with respect to the issue of a press release announcing holdings by FMR Corp, Fidelity International Limited and their subsidiaries in the ordinary share capital of the Company. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported December 2, 2002, with respect to the issue of a press release announcing that the Company would invest in a vaccine research center in Canada. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported December 4, 2002, with respect to the issue of a press release announcing an application for listing of shares issued upon exchange of Shire Acquisition Inc. exchangeable shares. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported December 6, 2002, with respect to the issue of a press release announcing holdings by Franklin Resources and its affiliates in the ordinary share capital of the Company. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported December 12, 2002, with respect to the issue of a press release announcing holdings by Franklin Resources and its affiliates in the ordinary share capital of the Company. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported December 19, 2002, with respect to the issue of a press release announcing the filing of a supplemental New Drug Application for adult Attention Deficit Hyperactivity Disorder. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported December 23, 2002, with respect to the issue of a press release announcing the exercise of share options and the sale of shares by Chief Executive Rolf Stahel. Form 8-K (Item 5 - Other Events, and Item 7 - Financial Statements and exhibits), date of earliest event reported December 30, 2002, with respect to the issue of a press release announcing the sale of the Company's over-the-counter products portfolio to Purdue Pharma L.P. 62 INDEX TO THE CONSOLIDATED FINANCIAL STATEMENTS Reports of Independent Auditors F-2 Consolidated Balance Sheets as of December 31, 2002 and 2001 F-4 Consolidated Statements of Operations for the years ended December 31, 2002, 2001 and 2000 F-6 Consolidated Statements of Changes in Shareholders' Equity for the years ended December 31, 2002, 2001 and 2000 F-8 Consolidated Statements of Comprehensive Income/(Losses) for the years ended December 31, 2002, 2001 and 2000 F-10 Consolidated Statements of Cash Flows for the years ended December 31, 2002, 2001 and 2000 F-11 Notes to the Consolidated Financial Statements F-14 F-1 Report of Independent Auditors To the Shareholders of Shire Pharmaceuticals Group plc: We have audited the accompanying consolidated balance sheets of Shire Pharmaceuticals Group plc and its subsidiaries as of December 31, 2002 and 2001, and the related consolidated statements of operations, comprehensive income, changes in shareholders equity, and cash flows for each of the three years in the period ended December 31, 2002. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. The consolidated financial statements give retroactive effect to the merger of Shire Pharmaceuticals Group plc and BioChem Pharma, Inc., which has been accounted for as a pooling of interests, as described in Note 3 to the consolidated financial statements. We did not audit the balance sheet of BioChem Pharma, Inc., a company acquired in 2001 in a transaction accounted for as a pooling of interests, as of December 31, 2000, or the related statements of income, shareholders' equity and cash flows of BioChem Pharma, Inc. for the year then ended, which statements reflect total assets of $578.1 million and total revenues of $517.6 million. Those statements were audited by other auditors whose report has been furnished to us, and our opinion, insofar as it relates to amounts included for BioChem Pharma Inc., for the year ended December 31, 2000 is based solely upon the report of such other auditors. We also audited the accounting policy alignments described in Note 4 that were applied to the 2000 audited financial statements of BioChem Pharma, Inc. In our opinion, such adjustments are appropriate and have been properly applied. We conducted our audits in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits and the report of the other auditors provide a reasonable basis for our opinion. In our opinion, based on our audit and the report of the other auditors, the financial statements referred to above present fairly, in all material respects, the financial position of Shire Pharmaceuticals Group plc and subsidiaries as of December 31, 2002 and 2001, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2002, in conformity with accounting principles generally accepted in the United States of America. As explained in note 12, effective January 1, 2002, the Company adopted SFAS No. 142, "Goodwill and Other Intangible Assets". Deloitte & Touche Reading, England February 26, 2003 F-2 Report of Independent Auditors To the shareholders of BioChem Pharma Inc. We have audited the consolidated balance sheets of BioChem Pharma Inc. as at December 31, 2000 and 1999 and the consolidated statements of earnings, changes in shareholders' equity and comprehensive income and cash flows for the years ended December 31, 2000, 1999 and 1998. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards in Canada for the years ended December 31, 2000, 1999 and 1998 and in accordance with auditing standards generally accepted in the United States of America for the year ended December 31, 2000. Those standards require that we plan and perform an audit to obtain reasonable assurance whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. In our opinion, these consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as at December 31, 2000 and 1999 and the consolidated results of its operations and its cash flows for the years ended December 31, 2000, 1999 and 1998 in accordance with generally accepted accounting principles in the United States of America. On January 25, 2001, we also reported separately to the shareholders of BioChem Pharma Inc. on consolidated financial statements for the same period, expressed in Canadian dollars, prepared in accordance with generally accepted accounting principles in Canada. Raymond Chabot Grant Thornton General partnership Chartered Accountants Montreal, Quebec January 25, 2001 F-3
CONSOLIDATED BALANCE SHEETS (In thousands of U.S. dollars, except share data) Notes December 31, December 31, 2002 2001 $'000 $'000 ---------- ---------- ASSETS Current assets: Cash and cash equivalents 897,718 118,040 Marketable securities (6) 316,126 723,911 Accounts receivable, net (7) 138,397 193,913 Inventories (8) 49,216 44,911 Deferred tax asset 34,849 19,430 Prepaid expenses and other current assets (9) 30,790 38,571 ---------- ---------- Total current assets from continuing operations 1,467,096 1,138,776 Current assets from discontinued operations (5) - 1,779 ---------- ---------- Total current assets 1,467,096 1,140,555 Investments (10) 71,962 68,743 Property, plant and equipment, net (11) 135,234 113,347 Goodwill, net (12) 203,767 175,341 Other intangible assets, net (12) 301,084 308,355 Deferred tax asset 6,216 20,274 Other non-current assets (13) 23,264 26,168 ---------- ---------- Total long-term assets from continuing operations 741,527 712,228 Long-term assets from discontinued operations (5) - 57,948 ---------- ---------- Total assets 2,208,623 1,910,731 ---------- ---------- LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Current installments of long-term debt (16) 888 4,325 Accounts payable and accrued expenses (14) 184,107 167,152 Unearned income - 17,409 Other current liabilities (15) 15,492 42,730 ---------- ---------- Total current liabilities from continuing operations 200,487 231,616 Current liabilities from discontinued operations (5) 12,784 - ---------- ---------- Total current liabilities 213,271 231,616 Long-term debt, excluding current installments (16) 407,302 402,481 Other non-current liabilities (17) 14,884 13,645 ---------- ---------- Total liabilities 635,457 647,742 ---------- ----------
F-4 CONSOLIDATED BALANCE SHEETS (continued) (In thousands of U.S. dollars)
Notes December 31, December 31, 2002 2001 $'000 $'000 ---------- ---------- Shareholders' equity: Common stock, 5p par value; 800,000,000 shares authorized; and 484,344,412 (2001: 481,817,487) shares issued and outstanding 40,051 39,861 Exchangeable shares: 5,874,112 (2001: 5,978,902) shares issued and outstanding 272,523 277,386 Additional paid-in capital 1,027,499 1,014,796 Accumulated other comprehensive losses (41,431) (93,009) Retained earnings 274,524 23,955 ---------- ---------- Total shareholders' equity 1,573,166 1,262,989 ---------- ---------- Total liabilities and shareholders' equity 2,208,623 1,910,731 ---------- ----------
The accompanying notes are an integral part of these consolidated financial statements. F-5
CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands of U.S. dollars, except share and per share data) Year ended December 31, Notes 2002 2001 2000 $'000 $'000 $'000 ---------- ---------- ---------- Revenues: Product sales 859,388 699,351 496,775 Licensing and development 3,064 5,498 14,147 Royalties 174,812 145,155 135,470 Other revenues 34 2,952 1,262 ---------- ---------- ---------- Total revenues (22) 1,037,298 852,956 647,654 Costs and expenses: Cost of product sales 133,682 112,006 95,071 Research and development (inclusive of stock option compensation charge on warrants of $4,502 for 2001) 189,179 171,029 155,145 Selling, general and administrative (inclusive of stock option compensation (credit)/charge of ($166), $2,278 and $21,914 for 2002, 2001 and 2000 respectively) 386,023 303,480 230,216 Other charges: (23) In process research and development - - 26,947 Asset impairments and restructuring charges - 29,699 - Merger transaction expenses - 83,470 - Loss on disposition of assets 1,376 10,164 - ---------- ---------- ---------- Total operating expenses 710,260 709,848 507,379 ---------- ---------- ---------- Operating income (22) 327,038 143,108 140,275 Interest income 19,536 19,667 19,232 Interest expense (9,252) (8,315) (16,413) Other (expense)/income, net (24) (8,262) (52,933) 109,023 ---------- ---------- ---------- Total other income/(expense), net 2,022 (41,581) 111,842 ---------- ---------- ---------- Income from continuing operations before income taxes, equity in earnings of equity method investees and extraordinary items 329,060 101,527 252,117 Income taxes (26) (88,350) (68,897) (43,564) Equity in earnings of equity method investees (27) 1,668 1,985 (3,809) ---------- ---------- ---------- Income from continuing operations before extraordinary item 242,378 34,615 204,744 Income from discontinued operations (net of income tax expense (5) of $3,588, $3,963 and $4,100 respectively) 6,108 6,748 6,983 Gain on disposition of discontinued operations (net of income (5) tax expense of $1,224) 2,083 - - Extraordinary item, net of income tax - (2,604) - ---------- ---------- ---------- Net income 250,569 38,759 211,727 ---------- ---------- ----------
F-6
CONSOLIDATED STATEMENTS OF OPERATIONS (continued) (In thousands of U.S. dollars, except share and per share data) Year ended December 31, Notes 2002 2001 2000 $'000 $'000 $'000 ---------- ---------- ---------- Earnings per share - basic (21) Income from continuing operations before extraordinary item 48.4c 7.0c 42.4c Income from discontinued operations 1.6c 1.4c 1.4c Extraordinary item, net of tax - (0.5)c - ---------- ---------- ---------- 50.0c 7.9c 43.8c ---------- ---------- ---------- Earnings per share - diluted (21) Income from continuing operations before extraordinary item 47.4c 6.9c 41.4c Income from discontinued operations 1.6c 1.3c 1.4c Extraordinary item, net of tax - (0.5)c - ---------- ---------- ---------- 49.0c 7.7c 42.8c ---------- ---------- ---------- Weighted average number of shares: Basic 500,687,594 492,594,226 482,890,070 Diluted 522,418,246 504,875,587 494,691,805 ---------- ---------- ----------
The results for the year ended December 31, 2000 have been restated to include the results of BioChem Pharma Inc., the merger with whom was accounted for as a pooling of interests in accordance with Accounting Principles Board Opinion No. 16 "Accounting for Business Combinations" (APB 16). The results for the years ended December 31, 2001 and 2000 have been restated to reflect the disposal of the "Over-The-Counter" (OTC) business which has been accounted for as a discontinued operation. The accompanying notes are an integral part of these consolidated financial statements. F-7
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (In thousands of U.S. dollars except share data) Exchange- Accumulated Accumulated Common Exchange- able (deficit)/ other Total Common stock able shares Additional retained comprehensive share- stock no. shares shares number paid-in earnings losses holders' amount amount shares capital equity $'000 000's $'000 000's $'000 $'000 $'000 $'000 --------- -------- --------- --------- --------- -------- ---------- --------- At December 31, 1999 39,241 474,400 - - 1,097,567 (226,531) (30,391) 879,886 Net income - - - - - 211,727 - 211,727 Foreign currency translation - - - - - - (31,467) (31,467) Issue of common stock 137 1,843 - - 11,720 - - 11,857 Issue costs - - - - (3,385) - - (3,385) Options exercised 914 11,772 - - 50,850 - - 51,764 Stock option compensation - - - - 21,914 - - 21,914 Tax benefit associated with exercise of stock options - - - - 30,782 - - 30,782 Reclassification of realized loss included in net income - - - - - - 1,356 1,356 Unrealized holding loss on available for sale investments - - - - - - (48) (48) -------- -------- --------- --------- --------- -------- ---------- --------- At December 31, 2000 40,292 488,015 - - 1,209,448 (14,804) (60,550) 1,174,386 Net income - - - - - 38,759 - 38,759 Foreign currency translation - - - - - - (32,507) (32,507) Issue of shares for acquisitions (3,662) (51,876) 802,256 17,292 (798,594) - - - Issue of common stock for conversion of loan 22 295 - - 1,522 - - 1,544 Issue costs - - - - (18) - - (18) Exchange of exchangeable shares 2,414 33,940 (524,870) (11,313) 522,456 - - - Options exercised 795 11,443 - - 69,397 - - 70,192 Stock option compensation and warrants - - - - 6,780 - - 6,780 Tax benefit associated with exercise of stock options - - - - 3,805 - - 3,805 Unrealized holding loss on available for sale investments - - - - - - 48 48 -------- -------- --------- --------- --------- -------- ---------- ---------- At December 31, 2001 39,861 481,817 277,386 5,979 1,014,796 23,955 (93,009) 1,262,989
F-8
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (continued) (In thousands of U.S. dollars except share data) At December 31, 2001 39,861 481,817 277,386 5,979 1,014,796 23,955 (93,009) 1,262,989 Net income - - - - - 250,569 - 250,569 Foreign currency translation - - - - - - 50,314 50,314 Issue of common stock for conversion of loan note 21 268 - - 1,479 - - 1,500 Exchange of exchangeable shares 22 315 (4,863) (105) 4,841 - - - Options exercised 147 1,944 - - 5,861 - - 6,008 Stock option compensation - - - - (166) - - (166) Tax benefit associated with exercise of stock options - - - - 688 - - 688 Unrealized holding gain on available for sale investments - - - - - - 1,264 1,264 -------- -------- --------- --------- --------- -------- --------- ---------- - At December 31, 2002 40,051 484,344 272,523 5,874 1,027,499 274,524 (41,431) 1,573,166 -------- -------- --------- --------- --------- -------- ---------- ----------
The results for the year ended December 31, 2000 have been restated to include the results of BioChem Pharma, Inc. the merger with whom was accounted for as a pooling of interests in accordance with APB 16. The accompanying notes are an integral part of these consolidated financial statements. F-9
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME/(LOSSES) (In thousands of U.S. dollars) Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Net income 250,569 38,759 211,727 Other comprehensive income/(loss): Foreign currency translation adjustments 50,314 (32,507) (31,467) Reclassification of realized loss included in net income - - 1,356 Unrealized holding gains/(losses) on available for sale securities 1,264 48 (48) ----------- ----------- ----------- Comprehensive income 302,147 6,300 181,568 ----------- ----------- -----------
The components of accumulated other comprehensive losses as at December 31, 2002 and 2001 are as follows:
December31, December 31, 2002 2001 $'000 $'000 ----------- ----------- Foreign currency translation adjustments (42,695) (93,009) Unrealized holding gains on non-current investments 1,264 - ----------- ----------- Accumulated other comprehensive losses (41,431) (93,009) ----------- -----------
There are no material tax effects related to the items included above. The results for the year ended December 31, 2000 have been restated to include the results of BioChem Pharma, Inc. the merger with whom was accounted for as a pooling of interests in accordance with APB 16. The accompanying notes are an integral part of these consolidated financial statements. F-10
CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands of U.S. dollars) Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net income 250,569 38,759 211,727 Adjustments to reconcile net income to net cash provided by operating activities: Acquired in-process research and development - - 26,947 Depreciation and amortization 36,434 45,809 37,987 Stock option compensation - options (166) 2,278 21,914 Stock option compensation - warrants - 4,502 - Tax benefit of stock option compensation, credited directly to equity 688 3,805 30,782 (Increase)/decrease in deferred tax asset (8,761) 1,229 3,782 Non-cash exchange gains and losses 12,495 (1,017) (1,676) Gain on sale of long-term investments - - (98,627) Loss on sale of property, plant and equipment 1,376 8,112 - Loss on sale of intangible assets - 2,052 1,514 Gain on sale of a business (3,307) - - Write-down of long-term investments 8,732 61,596 - Write-down of intangible assets 18,777 25,393 - Equity in (earnings)/losses of equity method investees (1,668) (1,985) 3,809 Other elements - 1,788 1,102 Changes in operating assets and liabilities, net of acquisitions: Decrease/(increase) in accounts receivable 61,159 (52,033) (52,570) (Increase)/decrease in inventory (5,327) 2,922 (7,916) Decrease/(increase) in prepayments and other current assets 8,662 (26,109) 1,215 Decrease in other assets 2,905 823 - (Decrease)/increase in accounts payable and other liabilities (8,642) 61,504 37,727 (Decrease)/increase in unearned income (17,409) 17,409 - Reserve for restructuring charges - - (83,608) ----------- ----------- ----------- Net cash provided by operating activities 356,517 196,837 134,109 ----------- ----------- -----------
F-11
CONSOLIDATED STATEMENTS OF CASH FLOWS (continued) (In thousands of U.S. dollars) Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ---------- ----------- ----------- CASH FLOWS FROM INVESTING ACTIVITIES: Redemption of/(investment in) marketable securities 407,653 (367,206) (186,019) Purchase of subsidiary undertakings (17,000) - - Expenses of acquisition (350) - (1,461) Net cash acquired with subsidiary undertakings 50 - - Additional investment in existing subsidiary - - (32,302) Purchase of long-term investments (5,933) (20,351) (16,995) Purchase of intangible assets (24,032) (35,986) (38,379) Purchase of property, plant and equipment (22,647) (13,604) (44,243) Purchase of other assets - - (6,658) Proceeds from sale of long-term investments 4,108 - 123,327 Proceeds from sale of property, plant and equipment 721 7,081 12,007 Proceeds from sale of intangible assets - 4,556 - Proceeds from sale of a business 71,000 - - Collection on notes receivable - - 766 Other investing activities - - (1,427) ----------- ----------- ----------- Net cash provided by/(used in) investing activities 413,570 (425,510) (191,384) ----------- ----------- ----------- CASH FLOWS FROM FINANCING ACTVITIES: Proceeds from issue of long-term debt - 400,000 - Payment of debt issuance costs - (9,000) - Changes in long-term debt, capital leases and notes (3,381) (207,762) (8,514) Proceeds from issue of common stock, net - 1,526 14,589 Proceeds from exercise of options 6,008 70,192 45,647 ----------- ----------- ----------- Net cash provided by financing activities 2,627 254,956 51,722 ----------- ----------- ----------- Effect of foreign exchange rate changes on cash and cash equivalents 6,964 (1,509) (1,975) ----------- ----------- ----------- Net increase/(decrease) in cash and cash equivalents 779,678 24,774 (7,528) Cash flows used in discontinued operations - - (1,708) ----------- ----------- ----------- Net increase/(decrease) in cash and cash equivalents 779,678 24,774 (9,236) Cash and cash equivalents at beginning of period 118,040 93,266 102,502 ----------- ----------- ----------- Cash and cash equivalents at end of period 897,718 118,040 93,266 ----------- ----------- -----------
F-12
CONSOLIDATED STATEMENTS OF CASH FLOWS (continued) (In thousands of U.S. dollars) Supplemental information associated with continuing operations: Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Interest paid 8,101 11,122 12,264 Income taxes paid 101,779 65,773 14,095 Non cash activities: Common stock issued for product acquisitions - - 3,085 Common stock issued on conversion of zero-coupon note 1,500 1,544 8,772 Capital leases assumed on acquisition of subsidiaries 6,266 - -
The results for the year ended December 31, 2000 have been restated to include the results of BioChem Pharma, Inc. the merger with whom was accounted for as a pooling of interests in accordance with APB 16. Supplemental disclosures for non-cash transactions: see note 29. The accompanying notes are an integral part of these consolidated financial statements. F-13 NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (In thousands of U.S. dollars, except where indicated) (1) Description of operations Shire Pharmaceuticals Group plc (Shire), and subsidiaries (collectively, the Company) is an emerging global international pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, gastro intestinal, oncology and anti-infectives. The Company's strategy is further supported by three technology platforms: advanced drug delivery, lead optimization for small molecules, and biologics. Shire has sales and marketing subsidiaries with a portfolio of products targeting the U.S., Canada, the U.K., the Republic of Ireland, France, Germany, Italy and Spain. Shire also covers other significant pharmaceutical markets indirectly through distributors. The business is operated and managed within three individual operating segments: U.S., International and Global Research and Development. Within these segments, revenues are derived primarily from three sources: sales of products by Shire's own sales and marketing operations, royalties (where Shire has out-licenced to third parties) and licensing and development fees. The Company has a particular interest in innovative therapies that are prescribed by specialist doctors as opposed to primary care physicians. The Company follows two main approaches: firstly to start projects in-house through research and advanced drug delivery, and secondly to in-license projects and products on reasonable commercial terms, and then to develop them and launch them. To complete its geographic coverage of the key world pharmaceutical markets, Shire intends to build a presence in Japan in the future. The Company's principal products include: o in the U.S., ADDERALL XR(R) and ADDERALL(R) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD); AGRYLIN(R) for the treatment of elevated blood platelets; PENTASA(R) for the treatment of ulcerative colitis; CARBATROL(R) for the treatment of epilepsy; and PROAMATINE(R) for the treatment of orthostatic hypotension. In addition, the Company receives royalties on sales of REMINYL* for the treatment of Alzheimer's disease, marketed by Johnson & Johnson, and on EPIVIR**, COMBIVIR** and TRIZIVIR** for the treatment of HIV/AIDS and EPIVIR-HBV** for the treatment of hepatitis B, each marketed by GlaxoSmithKline (GSK): o in the U.K. and the Republic of Ireland, the CALCICHEW(R)range, used primarily as adjuncts in the treatment of osteoporosis, and REMINYL, which was launched in September 2000 and is co-promoted by Janssen-Cilag: o in Canada, 3TC** for the treatment of HIV/AIDS, COMBIVIR and HEPTOVIR** (all marketed in partnership with GSK); AMATINE(R) and FLUVIRAL S/F(R), a vaccine for the prevention of influenza, and o in the Rest of the World, royalties on the sales of ZEFFIX** for the treatment of hepatitis B, marketed by GSK, and royalties on sales of REMINYL marketed by Johnson & Johnson. In addition, the Company has a number of products in late stage development including FOSRENOL(R) for the treatment of high blood phosphate levels associated with kidney failure and TROXATYL(R) for the treatment of leukemia and pancreatic cancer. The Company submitted the first regulatory submission for FOSRENOL under the European Mutual Recognition procedure on March 13, 2001 and a New Drug Application with the U.S. FDA on April 30, 2002. * Registered trademark of Johnson & Johnson ** Registered trademark of GlaxoSmithKline (R) Unless otherwise indicated, all product names set out in this document are trademarks of Shire or companies within the Shire Group, many of which are the subject of trademark registrations in certain territories. F-14 (2) Summary of significant accounting policies (a) Basis of preparation The accompanying consolidated financial statements include the accounts of Shire and all of its subsidiary undertakings after elimination of intercompany accounts and transactions. (b) Use of estimates in financial statements The preparation of financial statements, in conformity with U.S. generally accepted accounting principles, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Estimates and assumptions are primarily made in relation to provisions for product returns, litigation and sales deductions. (c) Revenue recognition The Company recognizes revenue when: o there is persuasive evidence of an arrangement; o delivery of products has occurred or services have been rendered; o the seller's price to the buyer is fixed or determinable; and o collectibility is reasonably assured. The Company's principal revenue streams and their respective accounting treatments are discussed below: (i) Product sales Revenue for the sales of products is recognized upon shipment to customers. Provisions for certain rebates, product returns and discounts to customers are provided for as reductions to revenue in the same period as the related sales are recorded. Approximately $17.0 million of ADDERALL XR product launch shipments made in the last quarter of 2001 were not recognized as product revenue until the first quarter of 2002, in accordance with Staff Accounting Bulletin 101, as these sales had not been realized and earned at December 31, 2001. (ii) Licensing and development fees Licensing and development fees represent revenues derived from license agreements and from collaborative research and development arrangements. Initial license fees are not considered to be separable from the associated research and development activities, even where such fees are non-refundable and not creditable against research and development services to be rendered. Initial license fees are thus deferred and recognized over the period of the license term, or the period of the associated research and development agreement. In circumstances where initial license fees are not for a defined period, revenues are deferred and recognized over the period to the expiration of the relevant patent to which the license relates. During the term of certain research and development agreements, the Company receives non-refundable milestones as certain technical targets are achieved. Revenues are recognized on achievement of milestones. The Company also receives non-refundable clinical milestones when certain targets are achieved during the clinical phases of development, such as the submission of clinical data to a regulatory authority. These clinical milestones are recognized when received. If milestone payments are creditable against future royalty payments, the milestones are deferred and released over the period in which the royalties are anticipated to be paid. (iii) Royalty income Royalty income relating to licensed technology is recognized when earned. Where applicable, all revenues are stated net of value added tax and similar taxes, trade discounts and intercompany transactions. No revenue is recognized for consideration, the value or receipt of which is dependent on future events, future performance, or refund obligations. F-15 (d) Research and development Research and development expenditures include funded and unfunded expenditures and are charged to operations in the period in which the expense is incurred. (e) Leased assets The costs of operating leases are charged to operations on a straight-line basis over the lease term, even if rental payments are not made on such a basis. Assets acquired under capital leases are included in the balance sheet as tangible fixed assets and are depreciated over the shorter of the period of the lease or their useful lives. The capital elements of future lease payments are recorded as liabilities, while the interest elements are charged to operations over the period of the leases to produce a level yield on the balance of the capital lease obligation. (f) Pensions The Group contributes to personal defined contribution pension plans of employees. Contributions are charged to the statement of operations as they become payable. Details relating to these contributions and the Supplemental Executive Retirement Plan (SERP) operated by the Group are given in note 25. (g) Finance costs of debt Finance costs of debt are recorded as a deferred asset and then amortized to the statement of operations over the term of the debt, using the effective interest method. Deferred financing costs relating to debt extinguishments are written off to the statement of operations in that period. (h) Income taxes The Company provides for income taxes in accordance with Statement of Accounting Standards (SFAS) No.109, "Accounting for Income Taxes" (SFAS No. 109). Deferred tax assets and liabilities are provided for differences between the carrying amounts in the financial statements and tax bases of assets and liabilities that will result in future taxable or deductible amounts. The deferred tax assets and liabilities are measured using the enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Income tax expense is computed as the tax payable or refundable for the period, plus or minus the change during the period in deferred tax assets and liabilities. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. (i) Earnings per share Earnings per share (EPS) is computed in accordance with SFAS No. 128, "Earnings per Share" (SFAS No. 128). Basic EPS is computed by dividing consolidated net income available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted EPS is computed by dividing consolidated net income available to common shareholders by the sum of the weighted average number of shares outstanding and the weighted average number of all potentially dilutive common shares. Such potentially dilutive common shares are excluded when the effect would be to increase earnings per share or reduce a loss per share. (j) Advertising expense The Company expenses the cost of advertising as incurred. Advertising costs amounted to $45.6 million, $21.8 million and $6.6 million for the years ended December 31, 2002, 2001 and 2000 respectively. F-16 (k) Foreign currency The functional currency of each of Shire's subsidiaries is the local currency. Monetary assets and liabilities in foreign currencies are translated into the relevant functional currency at the rate of exchange ruling at the balance sheet date. Transactions in foreign currencies are translated into the relevant functional currency at the rate of exchange ruling at the date of the transaction. Transaction gains and losses are recognized in arriving at operating income. The results of overseas operations, whose functional currencies are not U.S. dollars, are translated at the average rates of exchange during the period and their balance sheets at the rates ruling at the balance sheet date. The cumulative effect of exchange rate movements is included in a separate component of other comprehensive income. Foreign currency exchange transaction gains and losses on an after-tax basis included in consolidated net income in the years ended December 31, 2002, 2001, and 2000, pursuant to SFAS No. 52, "Foreign Currency Translation" (SFAS No. 52), amounted to a $0.3 million loss, $0.5 million loss and $2.1 million gain, respectively. (l) Employee stock plans SFAS No. 123, "Accounting for Stock Based Compensation" (SFAS No. 123) prescribes accounting and reporting standards for all stock-based compensation plans, including employee stock options. As allowed by SFAS No. 123, Shire has chosen to continue to account for stock based compensation using the intrinsic value method prescribed in Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees" (APB No. 25), and related interpretations. Accordingly, compensation cost of stock options is measured as the excess, if any, of the quoted market price of Shire's stock at the measurement date over the option exercise price and is charged to operations over the vesting period. For fixed plans, the measurement date is the grant date. For plans where the measurement date occurs after the grant date, referred to as variable plans, the compensation cost is re-measured on the basis of the current market value of the company's stock at the end of each reporting period. Shire recognizes compensation expense for variable plans with performance conditions if achievement of those conditions becomes probable. The Company's basis for electing accounting treatment under APB No. 25 is principally due to the satisfactory incorporation of the dilutive effect of these shares in the reported earnings per share calculation and the presence of pro forma supplemental disclosure of the estimated fair value methodology prescribed by SFAS No. 123 and SFAS No. 148, "Accounting for Stock-Based Compensation - Transition and Disclosure". At December 31, 2002, the Company has nine stock-based employee compensation plan, which are described more fully in Note 28 to the consolidated financial statements. The following table illustrates the effect on net income and earnings per share if the Company had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation. Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Net income As reported 250,569 38,759 211,727 Pro forma 226,319 8,791 227,018 ----------- ----------- ----------- Income per share As reported - basic 50.0c 7.9c 43.8c As reported - diluted 49.0c 7.7c 42.8c Pro forma - basic 45.2c 1.8c 47.0c Pro forma - diluted 44.4c 1.7c 45.9c ----------- ----------- ----------- (m) Cash and cash equivalents Cash and cash equivalents are defined as short-term highly liquid investments with original maturities of ninety days or less. (n) Marketable securities F-17 Marketable securities consist of commercial paper and institutional and managed cash funds. In accordance with SFAS No. 115 "Accounting for Certain Investments in Debt and Equity Securities (SFAS No. 115), and based on the Company's intentions regarding these instruments, the Company has classified all marketable securities as held-to-maturity and has accounted for these investments at amortized cost. Institutional and managed cash funds are short-term money market instruments, including bank and building society term deposits from a variety of companies with strong credit ratings. (o) Inventories Inventories, consisting primarily of finished goods, are stated at the lower of cost or net realizable value. Cost incurred in bringing each product to its present location and condition is based on purchase costs calculated on a first-in, first-out basis, including transport. Net realizable value is based on estimated normal selling price less further costs expected to be incurred to completion and disposal. Provision is made for obsolete, slow moving or defective items where appropriate. (p) Investments The Company has certain investments in equity securities. Investments are accounted for using the equity method of accounting if the investment gives the Company the ability to exercise significant influence, but not control over, the investee. Significant influence is generally deemed to exist if the Company has an ownership interest in the voting stock of the investee between 20% and 50%, although other factors, such as representation on the investee's Board of Directors and the impact of commercial arrangements, are considered in determining whether the equity method of accounting is appropriate. Under the equity method of accounting, the Company records its investments in equity-method investees on the consolidated balance sheet as "Investments" and its share of the investees' earnings or losses together with other-than temporary impairments in value as "Equity in earnings of equity method investees" on the consolidated statement of operations. All other equity investments, which consist of investments for which the Company does not have the ability to exercise significant influence, are accounted for under the cost method or at fair value. Investments in private companies are carried at cost, less provisions for other than temporary impairment in value. For public companies that have readily determinable fair values, the Company classifies its equity investments as available-for-sale and, accordingly, records these investments at their fair values with unrealized gains and losses included in "Accumulated other comprehensive loss", net of any related tax effect. Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities are included in other (expense)/income, net (see note 24). The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included as interest income. (q) Goodwill and other intangible assets (i) Goodwill Goodwill arising on the acquisition of subsidiary undertakings and businesses, representing any excess of the fair value of the consideration given over the fair value of the identifiable assets and liabilities acquired, is capitalized. Periods ending on or before December 31, 2001 For periods ending on or before December 31, 2001 goodwill recognized in respect of each significant business combination was amortized over a period of 5 to 30 years (weighted average 19 years) on a straight line basis depending on the nature of the goodwill, and was evaluated for impairment when events or changes in circumstance indicate, in management's judgment, that the carrying value of such assets may not be recoverable. Impairments of goodwill were recognized if expected undiscounted cash flows were not sufficient to recover the goodwill. If a material impairment was identified, goodwill was written down to its estimated fair value. Fair value was determined based on the present value of expected net cash flows to be generated by the business, discounted using a rate commensurate with the risks involved. F-18 Periods commencing January 1, 2002 Effective January 1, 2002, the Company adopted SFAS No. 142, "Goodwill and Other Intangible Assets" (SFAS No. 142). The statement directs that goodwill and intangible assets that have indefinite lives will not be amortized but rather will be tested at least annually for impairment. Intangible assets that have finite lives will continue to be amortized over their useful lives, but without the constraint of an arbitrary ceiling. Going forward, the Company will carry out an annual impairment review of goodwill as of September 30th date unless any events occur which trigger the need for an earlier impairment review. (ii) Other intangible assets Other intangible assets, which comprise intellectual property including trademarks for products with an immediate defined revenue stream and acquired for valued consideration, are recorded at cost and amortized in equal annual installments over the estimated useful life of the related product which range from 5 to 40 years (weighted average 23 years). Intellectual property with no defined revenue stream, where the related product has not yet completed the necessary approval process, is written off to operations on acquisition. The following factors are considered in estimating the useful lives. Where an intangible asset is a composite of a number of factors, the period of amortization is determined from considering these factors together: o regulatory and legal provisions, including the regulatory approval and review process, patent issues and actions by government agencies: o the effects of obsolescence, changes in demand, competing products and other economic factors, including the development of competing drugs that are more effective clinically or economically, and o actions of competitors, suppliers, regulatory agencies or others that may eliminate current competitive advantages (r) Property, plant and equipment Property, plant and equipment is shown at cost, less accumulated depreciation and any provision for impairment. Cost of significant assets includes capitalized interest incurred during the construction period. Depreciation is provided on a straight-line basis at rates calculated to write-off the cost less estimated residual value of each asset over its estimated useful life as follows: Buildings 20 to 50 years Office furniture, fittings and equipment 4 to 10 years Warehouse, laboratory and manufacturing equipment 4 to 10 years The cost of land is not depreciated. Expenditures for maintenance and repairs are charged to operations as incurred. The costs of major renewals and improvements are capitalized. At the time property, plant and equipment is retired or otherwise disposed of, the cost and accumulated depreciation are eliminated from the asset and accumulated depreciation accounts. The profit or loss on such disposition is reflected in operating income. (s) Impairment of long-lived assets other than goodwill and investments The Company periodically evaluates the recoverability of long-lived assets other than goodwill and investments in accordance with SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets" (SFAS No. 144). Whenever events or changes in circumstances indicate that the carrying amounts of those assets may not be recoverable, the Company compares undiscounted net cash estimated to be generated by those assets to the carrying amounts of those assets. When these undiscounted cash flows are less than the carrying amount of the assets, the Company records impairment losses to write the asset down to its estimated fair market value. This is usually calculated by reference to discounted estimated cash flows. F-19 (t) Concentration of risk Revenues are mainly derived from agreements with major pharmaceutical companies and relationships with pharmaceutical wholesale distributors and retail pharmacy chains. Significant customers are disclosed in note 22. Such clients have significant cash resources and therefore any credit risk associated with these transactions is considered minimal. Excess cash is invested in bank and building society term deposits and commercial paper from a variety of companies with strong credit ratings. These investments typically bear minimal credit risk. A significant proportion of revenue is derived from the sale of ADDERALL XR and ADDERALL. During 2002 and 2001, sales of these products were $427.7 million and $350.3 million respectively, representing 41% of total revenues in both years. As a result, factors affecting the sale or production of ADDERALL XR and ADDERALL would have a material adverse effect on our financial condition and results of operation. (u) Reclassifications Certain amounts reported in previous years have been reclassified to conform to the 2002 presentation. (v) New accounting pronouncements In June 2001, the Financial Accounting Standards Board (FASB) issued SFAS No. 143, "Accounting for Asset Retirement Obligations" (SFAS No. 143). SFAS No. 143 requires that the fair value of a liability for asset retirement obligations be recognized in the period in which it is incurred if a reasonable estimate of the fair value can be made. The associated asset retirement costs are capitalized as part of the carrying amount of the related long-lived asset. SFAS No. 143 is effective for financial statements issued for fiscal years beginning after June 15, 2002. The Company has assessed the potential impact of the adoption of SFAS No. 143 and concluded that there is no impact. In April 2002, the FASB issued SFAS No. 145, "Rescission of FASB Statements No.4, 44 and 64, Amendment of FASB Statement No.13 and Technical Corrections" (SFAS No. 145). The principal change is that gains or losses from extinguishment of debt which are classified as extraordinary items by SFAS No. 4 will no longer be classified as such. The provisions of SFAS No. 145 are effective for fiscal years beginning after May 15, 2002 although early application of the Statement related to the rescission of SFAS No. 4 is encouraged. The Company plans to adopt SFAS No. 145 for its fiscal year ending December 31, 2003. When adopted, prior extraordinary items related to the extinguishment of debt will need to be reclassified. The potential impact of the adoption of SFAS No. 145 will be to reclassify $2.6 million from extraordinary items to income expense. In June 2002, the FASB issued SFAS No. 146, "Accounting for Costs Associated with Exit or Disposal Activities" (SFAS No. 146), which addresses accounting and processing for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force (EITF) Issue 94-3, "Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit and Activity (including Certain Costs Incurred in a Restructuring)" (Issue 94-3). SFAS No. 146 requires that a liability for a cost associated with an exit or disposal liability be recognized when the liability is incurred. Under Issue 94-3, a liability for an exit cost was recognized at the date of an entity's commitment to an exit plan. Under SFAS No. 146, fair value is the objective for initial measurement of the liability. SFAS No. 146 is effective for exit or disposal activities that are initiated after December 31, 2002, with early application encouraged. We do no expect the adoption of SFAS No. 146 to have a material impact on our financial position, results of operations or cash flows. In November 2002, the FASB issued Interpretation (FIN) No. 45, "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others" (FIN 45). This interpretation elaborates on the disclosures to be made by a guarantor in its interim and annual financial statements about its obligations under certain guarantees that it has issued. It also clarifies that a guarantor is required to recognize, at the inception of a guarantee, a liability for the fair value of the obligation undertaken in issuing the guarantee. The disclosure requirements of FIN 45 are effective for interim and annual periods after December 15, 2002. The initial recognition and initial measurement requirements of FIN 45 are effective prospectively for guarantees issued or modified after December 31, 2002. We are assessing, but at this point do not believe the adoption of the recognition and initial measurement requirements of FIN 45 will have a material impact on our financial position, cash flows or results of operations. F-20 (v) New accounting pronouncements (continued) In January 2003, the FASB issued FIN No. 46, "Consolidation of Variable Interest Entities, an Interpretation of APB No. 51" (FIN 46). This interpretation requires certain variable interest entities to be consolidated by the primary beneficiary of the entity if the equity investors in the entity do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. FIN 46 is effective for all new variable interest entities created or acquired after January 31, 2003. For variable interest entities created or acquired prior to February 1, 2003, the provisions of FIN 46 must be applied for the first interim or annual period beginning after June 15, 2003. The Company is currently evaluating the effect that the adoption of FIN 46 will have on its results of operations and financial condition. (w) Statutory accounts The consolidated financial statements as of December 31, 2002 and 2001 and for each of the three years in the period ended December 31, 2002 do not comprise statutory accounts within the meaning of Section 240 of the UK Companies Act 1985. Statutory accounts prepared in accordance with generally accepted accounting principles in the United Kingdom for the years ended December 31, 2001 and 2000 have been delivered to the Registrar of Companies for England and Wales. The auditors' report on those accounts was unqualified. (3) Business combinations and reorganizations Year ended December 31, 2002 (a) Atlantic Pharmaceutical Services Inc acquisition On September 27, 2002, the Company completed its acquisition of Atlantic Pharmaceutical Services Inc. (APS) from Niro Inc. for cash consideration of $17.3 million, including $0.3 million costs of acquisition. This transaction provided the Company with an in-house facility in which to manufacture several key U.S. products. The acquisition was accounted for using the purchase method and goodwill of $10.2 million was recorded. The results of operations of APS have been included in the consolidated results of the Company since the date of acquisition. The purchase price of $17.3 million was allocated as follows: Fair value $'000 --------- Total current assets 3,188 Property, plant and equipment, net 11,620 Current installments of long-term debt (216) Accounts payable (1,367) Long-term debt, excluding current installments (6,050) --------- Net assets acquired 7,175 Goodwill 10,175 --------- 17,350 --------- Represented by: Purchase consideration 17,000 Acquisition fees 350 --------- 17,350 --------- F-21 (3) Business combinations and reorganizations (continued) Year ended December 31, 2002 (continued) The pro forma effect in 2002 and 2001 of the APS acquisition if acquired on January 1, 2002 and January 1, 2001 respectively would have resulted in revenues, income before extraordinary items, net income and earnings per share data as follows: Year ended December 31, 2002 2001 $'000 $'000 ---------- ---------- Revenues 1,042,748 861,660 Income before extraordinary items 248,983 41,428 Net income 248,983 38,824 ---------- ---------- Earnings per share - basic 49.7 7.9 Earnings per share - diluted 48.7 7.7 ---------- ---------- (b) Divestment of OTC products division On December 27, 2002, the Company completed its divestment of a group of non-strategic U.S. products, known collectively as the `Over-The-Counter' (OTC) products. The Company received sale proceeds of $71.0 million and recorded a gain on disposal of $2.1 million. In addition, there are potential warranties of up to $7 million in respect of the divestment, of which the Company has provided what it deems necessary at this stage. Further details of this discontinued operation are provided in note 5 below. Year ended December 31, 2001 (a) BioChem merger On May 11, 2001, the Company acquired 100% of the outstanding stock of BioChem Pharma, Inc. (BioChem), an international specialty pharmaceutical company based in Laval, Canada. The merger was achieved through an exchange of shares. Shire issued 179,447,629 common shares and 17,292,149 exchangeable shares in order to effect the business combination. Each exchangeable share is equivalent to 3 common shares and is exchangeable into common shares or ADSs at a rate of one exchangeable share for three common shares or one exchangeable share for one ADS, at any time at the request of the holder. Holders of exchangeable shares are entitled to the dividend and other rights that are economically equivalent to those of common shares. Through a voting trust and by means of special voting shares in Shire held by the trustee, holders of exchangeable shares are entitled to vote at shareholder meetings of the Company. Exchangeable shares are included in deriving the Company's weighted average number of shares for both basic and diluted earnings per share (see note 20) because they will become and are equivalent to common shares. This transaction was accounted for by the pooling of interests method in accordance with APB No. 16. Consequently, the consolidated financial statements give retroactive effect to the merger. Details of the results of operations of BioChem for the period before the merger was consummated, which is the period from January 1, 2001 to May 11, 2001, that are included in the combined net income of the Company are as follows: $'000 --------- Revenue 51,592 Net income 23,003 --------- Other changes in shareholders' equity: Issue of common shares on exercise of stock options 2,170 --------- F-22 Year ended December 31, 2001 (continued) (a) BioChem merger (continued) The revenues and earnings previously reported by the Company for the year ended December 31, 2000 can be reconciled to the combined amounts presented herein as follows: Revenue Net Income $'000 $'000 ---------- ---------- As previously reported 517,608 76,171 BioChem pooled results 198,478 174,346 Accounting policy alignment (see note 4) (44,976) (38,790) ---------- ---------- As restated for BioChem 671,110 211,727 Discontinued operations (see note 5) (23,456) - ---------- ---------- As reported 647,654 211,727 ---------- ---------- (b) Dispositions During 2001, the Company recorded a $8.1 million loss on the sale of its manufacturing facility in Toronto, Canada. As a result of the merger with BioChem, the decision was made to close the Toronto facility and to eliminate duplicate positions across the combined organization. The Company's existing Canadian based sales and marketing operations in Toronto were combined with those of BioChem in Laval. During the third quarter of 2001, the Company disposed of certain non strategic products for net proceeds of approximately $4.5 million. A loss on disposition of $2.1 million was recorded in operations. (4) Accounting policy alignment In 1998, BioChem spun-off its investments in CliniChem to its shareholders. In connection with this spin-off, BioChem retained rights in CliniChem, including the option to reacquire all shares in CliniChem at any time. Under EITF 99-16, this transaction would result in CliniChem continuing to be consolidated by BioChem, as BioChem would have significant continuing involvement in the operation of CliniChem. However, at the time that CliniChem was spun-off, EITF 99-16 had not been issued and BioChem elected to de-consolidate CliniChem, an acceptable accounting principle at that time. The management of Shire believe that their accounting policies would have required Shire to continue to consolidate CliniChem, also an acceptable accounting alternative at the date of the spin-off and a policy that conforms with the later guidance issued under EITF 99-16. The effect of this accounting policy alignment is to reduce the net income from continuing operations previously reported by BioChem now included in the pooled financial statements for 2000 by $38.8 million. On December 15, 2000 BioChem reacquired CliniChem. This acquisition has been reflected in the accompanying financial statements using purchase accounting. (5) Discontinued operations In December 1999 the Company acquired a group of products, collectively referred to as the OTC portfolio, through its merger with Roberts Pharmaceutical Corporation (Roberts). The OTC portfolio consisted of non-prescription laxatives and dietary supplements sold by the Company's U.S. operating segment. As a specialty pharmaceuticals company that focuses on prescription only products, this part of the business was not considered to be a core part of Shire's long-term strategy and hence the decision was made to divest the OTC portfolio in December 2002. On December 27, 2002, the Company completed its divestment of the OTC business. The Company received sale proceeds of $71.0 million and recorded a gain on disposal of $2.1 million. In addition, there are potential warranties of up to $7 million in respect of the divestment, of which the Company has provided what it deems necessary at this stage. The historical consolidated financial statements have been restated to reflect the OTC business as a discontinued operation for all periods presented. Operating results of the discontinued operations are summarized below. F-23 (5) Discontinued operations (continued) The amounts include income tax provisions based on the stand alone results of the OTC business. There have been no allocations of general and administrative corporate costs or interest expense related to corporate credit facilities to the discontinued operation. As the OTC business functioned within Shire US, which itself essentially functions as an independent entity, no corporate costs were eliminated upon discontinuance of the operation. Within Shire US, the OTC business had few dedicated resources. All of the products were manufactured and packaged by third party contract manufacturers. The products were distributed through a shared warehouse facility and sold through a small sales team. Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Product sales 24,010 24,613 23,456 Cost of product sales (5,764) (6,279) (6,300) ----------- ----------- ----------- Gross profit 18,246 18,334 17,156 ----------- ----------- ----------- Operating expenses: Selling, general and administrative (8,550) (7,623) (6,073) ----------- ----------- ----------- Operating income 9,696 10,711 11,083 Income taxes (3,588) (3,963) (4,100) ----------- ----------- ----------- Income from discontinued operations 6,108 6,748 6,983 Gain on sale (net of tax) 2,083 - - ----------- ----------- ----------- 8,191 6,748 6,983 ----------- ----------- ----------- The assets and liabilities of the discontinued operation are summarized below.
December 31 December 31 December 31 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Current assets: Inventories - 1,779 4,135 ----------- ----------- ----------- Long term assets: Goodwill and other intangible assets, net - 65,348 67,340 Deferred tax liability - (7,400) (6,354) ----------- ----------- ----------- Total long term assets - 57,948 60,986 ----------- ----------- ----------- Current liabilities: Other current liabilities (12,784) - - ----------- ----------- ----------- Total current liabilities (12,784) - - ----------- ----------- ----------- Net (liabilities)/assets (12,784) 59,727 65,121 ----------- ----------- -----------
Included in the 2002 other current liabilities are amounts for ongoing liabilities that were not transferred to the purchaser. F-24 (6) Marketable securities December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Commercial paper 87,843 246,174 Institutional and managed cash funds 228,283 477,737 ------------ ----------- 316,126 723,911 ------------ ----------- December 31, December 31, 2002 2001 Maturity profile of commercial paper $'000 $'000 ------------ ----------- Less than one month 7,297 168,678 1-3 months 12,981 - 3-6 months 67,565 77,496 ------------ ----------- 87,843 246,174 Maturity profile of institutional and managed cash funds $'000 $'000 ------------ ----------- Less than one month 63,600 477,737 1-3 months 20,373 - 3-6 months 45,090 - 6-12 months 25,192 - More than one year 74,028 - ------------ ----------- 228,283 477,737 ------------ ----------- (7) Accounts receivable, net December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Trade receivables 130,210 187,694 Research and development contracts 5,184 3,998 Other receivables 3,003 2,221 ------------ ----------- 138,397 193,913 ------------ ----------- Trade receivables included above are stated net of a provision for doubtful debts of $0.8 million (December 31, 2001: $1.1 million). Included within trade receivables as at December 31, 2002 is $nil in respect of unearned income relating to ADDERALL XR product sales (December 31, 2001: $17.0 million). Included within research and development contracts receivable are amounts due in respect of an agreement with the Canadian government, Technology Partnerships Canada (TPC), under which a contribution is made towards certain eligible research and development costs incurred by Shire's Canadian subsidiary, Shire BioChem Inc. This was $1.0 million at December 31, 2002. F-25 (8) Inventories December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Finished goods 27,672 18,101 Work-in-process 13,716 18,262 Raw materials 7,828 8,548 ------------ ----------- 49,216 44,911 ------------ ----------- (9) Prepaid expenses and other current assets December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Prepaid expenses 14,558 18,780 Deferred financing costs 1,208 1,077 Income tax receivable 12 7,712 Valued added taxes receivable 2,730 5,407 Other current assets 12,282 5,595 ------------ ----------- 30,790 38,571 ------------ ----------- The deferred financing costs relate to the $400 million convertible loan note (see note 16). These costs are being amortized over 10 years using the effective interest rate method. (10) Investments December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Investments in private companies 47,255 51,549 Investments in public companies 14,129 13,855 Equity method investments 10,578 3,339 ------------ ----------- 71,962 68,743 ------------ ----------- (a) Investments in private companies (i) GeneChem funds We have made investments in two venture capital funds. The fund managers distribute income to the partners of the funds in respect of dividends or realized gains made on sale of investments. In March 1997, we entered into an agreement to make an investment of CAN$30.0 million in the GeneChem Technologies Venture Fund L.P., a venture capital fund sponsored by our subsidiary, GeneChem Financial Corporation. This CAN$100.0 million Fund invests in advanced academic research projects and early stage private or public companies in the area of genomics and related technologies for human application. Our partners in this fund are a select group of financial investors. As of December 31, 2002, we have invested CAN$27.0 million in the GeneChem Technologies Venture Fund L.P. and we are, therefore, committed to investing a further $1.9 million (CAN$3.0 million) into this Fund. F-26 (10) Investments (continued) (a) Investments in private companies (continued) (i) GeneChem funds (continued) In September 2000, we entered into an agreement to invest CAN$15.0 million in the GeneChem Therapeutics Venture Fund L.P., which invests in genomics companies focusing on cancer and infectious diseases. As of December 31, 2002, we have committed to invest a further $4.3 million (CAN$6.8 million) in the GeneChem Therapeutics Venture Fund L.P. The manager and general partners of these funds are fully owned subsidiaries of the Company. These funds have not been consolidated because the operational substance of the funds are such that the other partners have the ability to veto investment decisions. (ii) EGS Healthcare fund In November 2000, we entered into an agreement to invest up to $10.0 million in various EGS healthcare funds. EGS is a private equity company that makes investments in healthcare companies that focus mainly on biotechnology and specialty pharmaceuticals. As of December 31, 2002, we have invested $5.1 million in EGS healthcare funds and we are, therefore, committed to invest a further $4.9 million into these funds. (b) Investments in public companies During the year ended December 31, 2002, there were no new investments made in public companies. In July 2002, the Company's $11.1 million preference share investment in Immunogen Inc. was converted in to a common stock holding. During the year, the Company wrote down the cost of investments in public companies by $1.4 million due to other than temporary impairments. This expense is included within non-operating other (expense)/income, net (see note 24). (c) Equity method investments The Company has accounted for its commercialization partnership with GSK (through which the products 3TC and ZEFFIX are marketed in Canada) using the equity method of accounting. The Company's share of the partnership is included within "Equity in earnings of equity method investees" and the related equity investment of $2.9 million is included above. In September 2002, the Company sold the net assets of its CADx group of companies, to Qualia Computing Inc, in exchange for shares in a newly formed joint venture. The common stock of the joint venture, Qualia Computing Inc., is 50% owned by Shire. The initial value of the investment was equal to the book value of assets sold, therefore, no gain or loss was recognized. The Company has applied the equity method of accounting as the Company owns, but does not exercise control over its 50% share of the joint venture. As a result, the Company's investment is valued at cost, adjusted for its share of the earnings or losses of the joint venture. The Company's share of the partnership is included within "Equity in earnings of equity method investees" and the related equity investment of $7.7 million is included above. There is no significant difference between the amount at which the investment is carried and the amount of the underlying equity in net assets of the joint venture. F-27 (11) Property, plant and equipment, net December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Land and buildings 111,164 95,921 Office furniture, fittings and equipment 31,210 12,659 Warehouse, laboratory and manufacturing equipment 46,706 46,613 ------------ ----------- 189,080 155,193 Less: Accumulated depreciation (53,846) (41,846) ------------ ----------- 135,234 113,347 ------------ ----------- Depreciation expense for the years ended December 31, 2002, 2001 and 2000 was $12.9 million, $14.4 million and $10.7 million respectively. (12) Goodwill and other intangible assets, net December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Goodwill arising on businesses acquired 254,207 220,890 Less: accumulated amortization (50,440) (45,549) ------------ ----------- 203,767 175,341 ------------ ----------- Other intangible assets acquired 397,807 379,986 Less: accumulated amortization (96,723) (71,631) ------------ ----------- 301,084 308,355 ------------ ----------- Total 504,851 483,696 ------------ ----------- The increase/(decrease) in the net book value of goodwill and other intangible assets for the year ended December 31, 2002 is shown in the table below: Other intangible Year ended December 31, 2002 Goodwill assets $'000 $'000 ------------ ----------- As at January 1, 2002 175,341 308,355 Acquisitions 10,175 23,467 Amortization charged - (23,493) Asset impairments - (18,777) Foreign currency translation 18,251 11,532 ------------ ----------- As at December 31, 2002 203,767 301,084 ------------ ----------- The acquisition of goodwill is in respect of APS (see note 3). Acquisitions of other intangible assets primarily related to SOLARAZE. The Company acquired the exclusive rights to manufacture, distribute and sell SOLARAZE for the treatment of actinic keratosis from SkyePharma plc. In May 2002, the Company paid $18.9 million ((pound)12.9 million) in respect of certain European territories, followed in December 2002 by a further $1.2 million ((pound)0.7 million) in respect of the rights for Australia, New Zealand, South Africa and certain other countries in the Pacific Rim. F-28 (12) Goodwill and other intangible assets, net (continued) Amortization charged for the years ended December 31, 2002, 2001 and 2000 was $23.5 million, $31.4 million and $27.3 million respectively. Goodwill was no longer amortized with effect from January 1, 2002 following the implementation of SFAS No. 142 (see below). Adoption of SFAS No. 142 As described in note 2, the Company adopted SFAS No. 142 as of January 1, 2002. A transitional assessment of goodwill impairment as of January 1, 2002 was completed by June 30, 2002. Management concluded that the fair value of the Company's individual reporting units exceeded the carrying value of the net assets including goodwill, and hence this process did not result in any impairment to be recorded on adoption of SFAS No. 142. The Company completed a second goodwill impairment review as of September 30, 2002 and found that no adjusting entries were necessary. A reconciliation table is provided below to exclude the effect of goodwill amortization in accordance with the transitional disclosures relating to SFAS No. 142. Results for the year ended December 31, 2002 have been prepared in accordance with SFAS No. 142.
Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Income from continuing operations before extraordinary items as reported 242,378 34,615 204,744 Add back of goodwill amortization charge - 10,763 11,324 ----------- ----------- ----------- Adjusted income from continuing operations before extraordinary items 242,378 45,378 216,068 ----------- ----------- ----------- Net income as reported 250,569 38,759 211,727 Add back of goodwill amortization charge - 10,763 11,324 ----------- ----------- ----------- Adjusted net income for basic earnings per share 250,569 49,522 223,051 Interest charged on convertible debt, net of tax 5,585 - - ----------- ----------- ----------- Adjusted net income for diluted earnings per share 256,154 49,522 223,051 ----------- ----------- ----------- Basic earnings per share (in $): Net income as reported 50.0 7.9 43.8 Add back goodwill amortization charge - 2.2 2.3 ----------- ----------- ----------- Adjusted net income 50.0 10.1 46.1 ----------- ----------- ----------- Diluted earnings per share (in $): Net income as reported 49.0 7.7 42.8 Add back goodwill amortization charge - 2.1 2.3 Interest charged on convertible debt, net of tax 0.1 - - ----------- ----------- ----------- Adjusted net income 49.1 9.8 45.1 ----------- ----------- ----------- Weighted average number of shares: No. of shares No. of shares No. of shares ----------- ----------- ----------- Basic 500,687,594 492,594,226 482,890,070 Diluted 522,418,246 504,875,587 494,691,805
F-29 Adoption of SFAS No. 142 There is no tax effect related to the goodwill amortization disclosed above. The useful economic lives of all intangible assets that continue to be amortized under SFAS No. 142 have been assessed. Management estimates that the annual amortization charges in respect of intangible fixed assets held at December 31, 2002 will be approximately $13.2 million for each of the five years to December 31, 2007. Estimated amortization expense can be affected by various factors including future acquisitions and disposals of product rights. The net book value of goodwill by operating segment is as follows: December 31, U.S. International R&D Total $'000 $'000 $'000 $'000 ------------ ------------- ------------- -------- 2002 174,617 29,150 - 203,767 2001 148,660 26,681 - 175,341 ------------ ------------- ------------- -------- During the year ended December 31, 2002, the Company acquired exclusive rights to manufacture, distribute and sell SOLARAZE in certain countries. The purchase cost was $20.1 million. The amortization period in respect of this product is 10 years. (13) Other non-current assets December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Deferred financing costs 7,915 8,617 SERP investment 12,070 14,367 Other assets 3,279 3,184 ------------ ----------- 23,264 26,168 ------------ ----------- The deferred financing costs at December 31, 2002 and 2001 were in respect of the $400 million convertible loan note. These costs are being amortized over 10 years. The current element of these costs is included within prepaid expenses and other current assets (note 9). Further details of the Supplemental Executive Retirement Plan (SERP) investment are provided in note 25. The amount shown above is the cash surrender value of life insurance policies which is backed by marketable securities. A liability of $8.4 million is included within note 17 (2001: $11.3 million). (14) Accounts payable and accrued expenses December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Trade accounts payable 46,912 51,952 Accrued rebates and charge-backs 45,919 41,086 Accrued expenses 91,276 74,114 ------------ ----------- 184,107 167,152 ------------ ----------- F-30 (15) Other current liabilities December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Income taxes payable 5,440 25,604 Payable for termination of license agreement - 738 Interest on long-term debt 2,893 2,928 Social security liabilities 1,934 7,237 Value added taxes 1,957 1,148 Other accrued liabilities 3,268 5,075 ------------ ----------- 15,492 42,730 ------------ ----------- (16) Long-term debt December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Total obligations 408,190 406,806 Current maturities of long-term obligations (888) (4,325) ------------ ----------- Total long-term debt 407,302 402,481 ------------ ----------- An analysis of total obligations by loan type is presented below: December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Convertible notes due 2011 400,000 400,000 Unsecured convertible zero coupon loan notes - 1,450 Canadian provincial and federal government loan 1,880 3,100 Bank term loans - 2,256 Capital leases 6,310 - ------------ ----------- 408,190 406,806 ------------ ----------- Principal payments in each of the next five years and thereafter on total obligations outstanding at December 31, 2002 amount to: December 31, 2002 $'000 ----------- 2003 888 2004 400,897 2005 863 2006 254 2007 272 Thereafter 5,016 ----------- 408,190 ----------- F-31 (16) Long-term debt (continued) The principal payments presented above have been calculated on the basis that the $400 million convertible notes due 2011 convert to common shares or will be paid as cash at the earliest opportunity, which is August 21, 2004. Further details in respect of the convertible notes are presented below. (i) Convertible notes due 2011 The $400 million of guaranteed convertible notes due 2011, were issued in August 2001 by Shire Finance Limited (the Issuer), a wholly owned subsidiary. The convertible notes are guaranteed by Shire and are convertible into redeemable preference shares of the Issuer which upon issuance will be immediately exchanged for either (i) Shire common shares or (ii) Shire ADSs, or (iii) at the Issuer's option, a cash amount based upon the London Stock Exchange volume-weighted average prices of common shares on the fourth through eighth business days following conversion. At the choice of investors, each $1000 of nominal value notes can be converted into 49.62 Shire common shares (subject to adjustment) or 16.54 Shire ADSs (subject to adjustment) at any time up to August 21, 2011. Alternatively, investors can choose to receive repayment of the nominal principal in cash either at the maturity date of August 21, 2011 or by exercising a put option on any of the three put dates being August 21, 2004, August 21, 2006 and August 21, 2008. At the option of the Company, repayment can be made in the form of Shire common shares or ADSs. The number of common shares that a note holder would receive would be based on the notional principal of the notes divided by 95% of the London Stock Exchange volume-weighted average price of common shares on the five trading days after the Company gives notice of the exercise of its option. Such notice will be on or before the tenth business day preceding the repayment put date. On or after August 21, 2004, the Company may redeem, for cash, all or part of the notes providing the Ordinary Share price has exceeded $26.20 (Sterling equivalent at the time) for 20 of the 30 consecutive dealing days in the period prior to redemption. The decision as to whether a note holder should exercise a put option will depend on a number of factors particularly the price of Shire stock at the put date and the likelihood of the Company's stock price exceeding the conversion threshold price. The conversion threshold price is equivalent to $20.15 or (pound)12.52 (at the closing exchange rate for 2002) for Shire common shares and $60.46 for Shire ADSs. If the price of Shire common shares at the first put date of August 21, 2004 remains at a level similar to the year end price of (pound)3.97 ($18.89 for Shire ADSs) it is quite possible that note holders will choose to exercise their put options. The Company currently has adequate resources from which it could satisfy repayment of the entire convertible debt principal of $400m. The interest expense recorded in the year ended December 31, 2002 was $8.0 million (2001: $2.9 million). (ii) Unsecured convertible zero coupon loan notes The Company financed the purchase of intellectual property relating to the manufacture of ADDERALL from Arenol Corporation by a total of $11.8 million in loan notes. On March 5, 1999 the Company issued a $5.8 million principal amount Unsecured Convertible Zero Coupon Loan note due July 30, 2001 (the First Loan Note) and a $6.0 million principal amount Unsecured Convertible Zero Coupon Loan Note due July 30, 2004 (the Second Loan Note). Both loan notes were in the name of the parent company, Shire. The agreement provided for the cancellation of certain specified amounts of the aggregate principal amount of the First Loan Note and of such amounts of the Second Loan Note on certain dates to the extent of certain indemnified losses or, to the extent that such amounts of the First Loan Note or the Second Loan Note (together the Loan Notes) were not so cancelled, for their conversion into common shares. The number of common shares was calculated by dividing the amount not cancelled by the lower of (pound)3.565 (approximately $5.75) and the midweek closing price of the common shares on the London Stock Exchange on the relevant date. Translation from pounds sterling to U.S. dollars was made using the exchange rate on the relevant date. The Company has issued common shares to Arenol Corporation (or its nominee broker), as set out in the table below, in consideration of the conversion of each of the Loan Notes. As at December 31, 2002 there is no liability remaining. F-32 (ii) Unsecured convertible zero coupon loan notes (continued) No. of common Date of conversion shares issued $'000 ------------ ----------- March 13, 2000 533,279 3,000 August 3, 2000 560,076 2,800 November 6, 2000 541,478 3,000 July 30, 2001 295,061 1,500 August 6, 2002 267,572 1,500 ----------- ----------- 2,197,466 11,800 ----------- ----------- (iii) Canadian federal and provincial government loan The Company has a Canadian federal and provincial government loan outstanding of $1.9 million (CAN$3.0 million). This facility is non-interest bearing and is repayable in annual installments of $0.6 million (CAN$1.0 million). (iv) Bank term loans The Company had a bank term loan at December 31, 2001 bearing interest at the lender's prime rate, which was secured by a charge on land and buildings. The final payment in respect of this loan was made in May 2002. (v) Capital leases December 31, December 31, Obligations under capital leases 2002 2001 $'000 $'000 ------------ ----------- Current 261 - Non-current 6,049 - ------------ ----------- 6,310 - ------------ ----------- The following is an analysis of the leased property under capital leases by major asset classes: December 31, December 31, Classes of property 2002 2001 $'000 $'000 ------------ ----------- Land and buildings 6,259 - Office furniture, fittings and equipment 160 - ------------ ----------- 6,419 - Less: accumulated depreciation (126) - ------------ ----------- 6,293 ------------ ----------- F-33 (16) Long-term debt (continued) (v) Capital leases(continued) The following is a schedule by years of future minimum lease payments under capital leases together with the present value of the net minimum lease payments as of December 31, 2002. December 31, 2002 $'000 ----------- 2003 261 2004 270 2005 237 2006 254 2007 272 Thereafter 5,016 ----------- 6,310 ----------- (17) Other non-current liabilities December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- SERP (note 25) 8,364 11,348 Other accrued liabilities 6,520 2,297 ------------ ----------- 14,884 13,645 ------------ ----------- (18) Financial instruments The estimated fair value of the Company's financial instruments at December 31, is summarized below. Certain estimates and judgments were required to develop the fair value amounts. The fair value amounts shown below are not necessarily indicative of the amounts that the Company would realize upon disposition nor do they indicate the Company's intent or ability to dispose of the financial instrument. The following methods and assumptions were used to estimate the fair value of each material class of financial instrument: o Marketable securities - the carrying value of marketable securities approximates fair value because of the short-term nature of these investments. o Investments - non-current investments with readily determinable market values are marked to market. o Long-term debt - the fair value of long-term debt is estimated based on the discounted future cash flows using currently available interest rates or, where the debt instrument is traded, by reference to the market price. F-34 (18) Financial instruments (continued) The carrying amounts and corresponding fair values of financial instruments at December 31, 2002 and 2001 were as follows: December 31, 2002 Carrying Amount Fair Value $'000 $'000 ------------ ----------- Financial assets: Commercial paper 87,843 87,843 Institutional and managed cash funds 228,283 228,283 Investments 14,129 14,129 Financial liabilities: Long-term debt 408,190 376,883 ------------ ----------- December 31, 2001 Carrying Amount Fair Value $'000 $'000 ------------ ----------- Financial assets: Commercial paper 246,174 246,174 Institutional and managed cash funds 477,737 477,737 Investments 13,855 13,855 Financial liabilities: Long-term debt 406,806 394,206 ------------ ----------- (19) Leases and other commitments (a) Leases The Company leases facilities, motor vehicles and certain office equipment under operating leases. The Company's commitments under the non-cancelable portion of all operating leases for the next five years and thereafter as of December 31, 2002 are as follows: December 31, 2002 $'000 ----------- 2003 7,215 2004 7,887 2005 5,855 2006 4,085 2007 3,038 Thereafter 12,805 ----------- 40,885 ----------- Lease and rental expense included in selling, general and administrative expenses in the accompanying statements of operations amounted to $6.7 million, $6.1 million and $4.3 million for the fiscal years ended December 31, 2002, 2001 and 2000 respectively. F-35 19) Leases and other commitments (b) Contingent liabilities (i) Commitments The Company has undertaken to subscribe to interests in companies and partnerships for amounts totaling $38.1 million (December 31, 2001: $37.7 million). As at December 31, 2002 an amount of $20.3 million (December 31, 2001: $20.1 million) has been subscribed. (ii) FLUVIRAL The Company signed a ten-year contract with the Government of Canada in 2001 to assure a state of readiness in the case of an influenza pandemic (worldwide epidemic) and to provide influenza vaccine for all Canadian citizens in such an event. Under the contract, Shire Biologics will also supply the Government of Canada with a substantial proportion of its annual influenza vaccine requirements over the ten-year period. Subject to mutual agreement, the contract can be renewed for a further period of between one and ten years from 2011. The concept of a state of readiness against an influenza pandemic requires the development of sufficient infrastructure and capacity in Canada to provide 100% of domestic vaccine needs in the event of an influenza pandemic. Canada would require 32 million doses of single-strain (monovalent) flu vaccine within a production period of 16 weeks. Shire Biologics has therefore begun to expand its production capacity in order to meet this objective within a five-year period. Shire Biologics is committed to CAN$18 million (approximately $11.3 million) of capital expenditure on immoveables for the purpose of achieving the level of pandemic readiness required. In addition, a performance bond equal to 10% of the minimum estimated contract value in any year, which for 2002/2003 will be CAN$19.2 million (approximately $12 million), would become payable to the Government of Canada if contracted penalty clauses were triggered. (c) Legal proceedings (i) General Shire accounts for litigation losses in accordance with Statement of Financial Accounting Standards (SFAS) No. 5, "Accounting for Contingencies." Under SFAS No. 5, loss contingency provisions are recorded for probable losses when management is able to reasonably estimate the loss. Where the estimated loss lies within in a range and no particular amount within that range is a better estimate than any other amount the minimum amount is recorded. In other cases management's best estimate of the loss is recorded. These estimates are developed substantially earlier than the ultimate loss is known, and the estimates are refined each accounting period, in light of additional information being known. In instances where Shire is unable to develop a best estimate of loss, no litigation loss is recorded at that time. As information becomes known a loss provision is set up when a best estimate can be made. The best estimates are reviewed quarterly and the estimates are changed when expectations are revised. (ii) Phentermine Shire US Inc. (SUS) is a defendant in eleven lawsuits still pending in both U.S. federal and state courts which seek damages for, among other things, personal injury arising from phentermine products supplied for the treatment of obesity by SUS and several other pharmaceutical companies. SUS, formerly known as Shire Richwood Inc., has been sued as a manufacturer and distributor of phentermine, an anorectic used in the short-term treatment of obesity and one of the products addressed by the lawsuits. The suits relate to phentermine either alone or together with fenfluramine or dexenfluramine. The lawsuits generally allege the following claims: the defendants marketed phentermine and other products for the treatment of obesity and misled users about the products and dangers associated with them; the defendants failed adequately to test phentermine individually and when taken in combination with the other drugs; and the defendants knew or should have known about the negative effects of the drugs and should have informed the public about such risks and/or failed to provide appropriate warning labels. SUS has been named as a defendant in a total of 3,804 such phentermine lawsuits, in respect of which SUS has been dismissed as a defendant in 3,756 cases. Shire is awaiting the furtherance of proceedings in the remaining 37 law suits. SUS became involved with phentermine through its acquisition of certain assets of Rexar Pharmacal Corporation (Rexar) in January 1994. In addition to SUS potentially incurring liability as a result of its own production of Oby-Cap, a phentermine product, the plaintiffs may additionally seek to impose liability on SUS as successor to Rexar. SUS intends vigorously to defend all the lawsuits and pursue all available reasonable defenses. SUS denies liability on a number of grounds including lack of scientific evidence that phentermine, properly prescribed, causes the alleged side effects and that SUS did not promote phentermine for long-term combined use as part of the "fen/phen" diet. Accordingly, SUS intends to defend vigorously any and all claims made against the Group in respect of phentermine and believes that F-36 19) Leases and other commitments (continued) (c) Legal proceedings (continued) (ii) Phentermine (continued) liability is neither probable nor quantifiable at this stage of litigation. Legal expenses have been paid by Eon Labs Manufacturing Inc. (Eon), the supplier to SUS, or Eon's insurance carriers but such insurance is now exhausted. Eon has agreed to defend and indemnify SUS in this litigation pursuant to an agreement dated November 30, 2000 between Eon and SUS. At the present stage of litigation, Shire is unable to estimate the level of future legal costs after taking into account any available product liability insurance and enforceable indemnities. To the extent that any legal costs are not covered by insurance or available indemnities, these will be expensed as incurred. (iii) ADDERALL Shire's extended release "once daily" version of ADDERALL, ADDERALL XR is covered by US patent No. 6,322,819 ("the '819 Patent"). In January 2003 we received a Paragraph IV notice from Barr alleging that this patent is invalid and not infringed by Barr's extended release mixed amphetamine salt product which is the subject of a Barr pending ANDA application. On February 24, 2003 Shire Laboratories Inc. filed suit against Barr in the US District Court for the Southern District of New York for infringement of the '819 Patent with respect to this ANDA. The Hatch-Waxman Act provides for an automatic stay of up to 30 months of FDA approval for Barr's ANDA to market its generic version of Adderall XR to allow the Court to resolve the patent infringement lawsuit. However, there can be no assurance that the Company will be successful in the suit. In the event that the Company does not prevail, then Barr could be in a position to market its extended release mixed amphetamine salt product upon FDA final approval of its ANDA application. This may have a material adverse impact on the Company's results and financial position . In the event that the Company does not prevail in the suit, a generic version of Adderall XR could not be launched before October 2004, the current expiry of the existing Hatch-Waxman exclusivity. Shire filed a Complaint against Barr on April 30, 2002 in the District Court of New Jersey. In the Complaint, Shire requested a preliminary and permanent injunction to prevent Barr from marketing a mixed amphetamine salt product in a trade dress similar to that of ADDERALL. Shire requested that Barr recall all such products and also asked for damages. An order denying the preliminary injunction was issued on August 26, 2002. Shire filed a Notice of Appeal to the United States Court of Appeals for the Third Circuit on September 16, 2002 appealing the denial of Shire's motion for a preliminary injunction. (iv) Emory Shire BioChem was involved in worldwide patent disputes with Emory University (Emory) relating to lamivudine wherein Shire BioChem opposed certain patents and patent applications of Emory and wherein Emory opposed certain patents and patent applications of Shire BioChem. Pursuant to a global Settlement Agreement, finalized in May 2002, Emory has granted Shire and GSK an exclusive license under Emory's patent rights for lamivudine. The Settlement Agreement provides for the resolution of all worldwide patent disputes between the parties relating to lamivudine and FTC, including pending opposition and revocation proceedings in Europe, South Korea and Australia. The settlement involves a small royalty payment on worldwide sales of lamivudine and a license under Shire's FTC patent rights, in consideration for the settlement of all claims against Shire and GSK relating to lamivudine. Shire BioChem was also involved in worldwide patent disputes with Emory and the University of Georgia Research Foundation (Georgia) relating to certain dioxolane nucleoside analogs wherein Shire BioChem opposed certain patents and patent applications of Emory and Georgia and wherein Emory opposed a European patent of Shire BioChem. Pursuant to global Settlement and License Agreements finalized in August 2002 by Shire BioChem, Shire, Georgia and Triangle Pharmaceuticals Inc. (Triangle), Shire will grant an exclusive royalty bearing license to Emory, sub licensable to Triangle, for certain dioxolane nucleoside analogs, including diamino purine dioxolane (DAPD). Emory, Georgia and Triangle will grant an exclusive royalty bearing license to Shire for certain dioxolane nucleosides, including SPD 756. The compounds the subject of these licenses are in development. A low royalty will be payable by Shire upon commercialization of SPD 756. The Settlement and License Agreements provide for the resolution of all worldwide patent disputes relating to the licensed patents. (v) Other matters In addition, the Company is involved in claims and lawsuits in the normal course of business. It is not possible at this time to determine the ultimate outcome of any of these claims. F-37 (20) Related parties (a) Mr Spitznagel Mr Spitznagel, a former Director of the Company, who resigned during the year ended December 31, 2001, entered into a consultancy agreement with the Company in December 1999, which provided that: o If he had good reason, as defined in his service agreement with Roberts, to terminate his employment with Roberts under his service agreement, the Company would cause Roberts to provide him with the payments and benefits he would be entitled to upon a `good reason' termination; o Mr Spitznagel would provide consulting services to the Company for at least 42 months following the acquisition of Roberts, unless Mr Spitznagel terminated the consultancy agreement prior to the end of the 42nd month upon 30 days notice; and o The Company would pay Mr Spitznagel at a rate of $400,000 per annum for his consulting services, $150,000 per annum as an office allowance, $250,000 per annum to comply with certain restrictive covenants contained therein and $150,000 per annum for tax, financial and estate planning advice, life insurance and health insurance. The amount owed to Mr Spitznagel at December 31, 2002 was $0.5 million (at December 31, 2001 it was $1.4 million). (b) Professional fees The Company incurred professional fees with law firms, in which the Hon James Grant, a director of the Company, is a partner, totaling $1,239 for the year ended December 31, 2002 ($1.9 million for the year ended December 31, 2001 and $0.4 million for the year ended December 31, 2000). No amounts were due to/from the law firms in which the Hon James Grant is a partner at December 31, 2002, or at December 31, 2001. (c) Immunosystems BioChem Immunosystems Inc (Immunosystems), formally a wholly owned subsidiary of BioChem, was sold in February 2000 to a third party. Dr Bellini, the former chief executive officer of BioChem, continued as a director of Immunosystems. In December 2001, the Company acquired a 19.9% equity interest in Immunosystems in consideration for the release of a debt owing to the Company from Immunosystems. This debt existed prior to the Company's merger with BioChem. As part of the same transaction, the Company was released from a pre-existing BioChem guarantee over other Immunosystems' liabilities. (21) Earnings per share The following table reconciles income from continuing operations before extraordinary items and the weighted average common shares outstanding for basic and diluted EPS for the periods presented:
Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Income from continuing operations before extraordinary items 242,378 34,615 204,744 ----------- ----------- ----------- Income from discontinued operations, net of tax 8,191 6,748 6,983 Extraordinary item, net of tax - (2,604) - ----------- ----------- ----------- Net income 250,569 38,759 211,727 ----------- ----------- ----------- Effect of dilutive securities: Interest charged on convertible debt, net of tax 5,585 - - ----------- ----------- -----------
F-38 (21) Earnings per share (continued)
Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Weighted average number of shares outstanding No. of shares No. of shares No. of shares ----------- ----------- ----------- Earnings per share - basic 500,687,594 492,594,226 482,890,070 Effect of dilutive securities: Share options 1,883,475 11,362,332 11,801,735 Convertible debt 19,847,177 - - Warrants - 919,029 - ----------- ----------- ----------- 21,730,652 12,281,361 11,801,735 ----------- ----------- ----------- Earnings per share - diluted 522,418,246 504,875,587 494,691,805 ----------- ----------- ----------- Earnings per share - basic Income from continuing operations before extraordinary items 48.4c 7.0c 42.4c Income from discontinued operations, net of tax 1.6c 1.4c 1.4c Extraordinary item, net of tax - (0.5c) - ----------- ----------- ----------- 50.0c 7.9c 43.8c ----------- ----------- ----------- Earnings per share - diluted Income from continuing operations before extraordinary items 47.4c 6.9c 41.4c Income from discontinued operations, net of tax 1.6c 1.3c 1.4c Extraordinary item, net of tax - (0.5c) - ----------- ----------- ----------- Earnings per share - diluted 49.0c 7.7c 42.8c ----------- ----------- -----------
The computation of weighted average number of shares for diluted EPS for the years ended December 31, 2001 and 2000 does not include convertible debt because, after eliminating interest charged to operations from the numerator, the inclusion would be anti-dilutive. The warrants are issuable in respect of a research and development agreement. A charge of $4.5 million has been made in the results for the year ended December 31, 2001. The warrants and share options not included within the calculation of the diluted weighted average number of shares, because the exercise prices exceeded the Company's average share price during the calculation period, are shown below. Year ended December 31, 2002 2001 2000 No. of shares No. of shares No. of shares ----------- ----------- ----------- Share options 17,492,575 10,384,600 - Warrants 1,346,407 - - ----------- ----------- ----------- 18,838,982 10,384,600 - ----------- ----------- ----------- F-39 (22) Analysis of revenues, operating income/(loss) and assets by reportable segments The Company has disclosed segment information for the individual operating areas of the business, based on the way in which the business is managed and controlled. Shire's principal reporting segments are geographic, each being managed and monitored separately and serving different markets. The Company evaluates performance based on operating income or loss before interest and income taxes. The accounting policies of each reportable segment are consistent with those of the Company. Operating income/(loss)
Year ended December 31, 2002 U.S. International R&D Total $'000 $'000 $'000 $'000 ------------ ------------- ------------- ------------- External revenues: Product sales 714,655 144,733 - 859,388 Licensing and development 2,661 403 - 3,064 Royalties 215 174,597 - 174,812 Other revenues - 34 - 34 Intersegment revenues 21,169 - 127,823 148,992 ------------ ------------------------ ------------- ------------- 738,700 319,767 127,823 1,186,290 Elimination of intersegment sales (21,169) - (127,823) (148,992) ------------ ------------------------ ------------- ------------- Total revenues 717,531 319,767 - 1,037,298 Cost of revenues 63,356 70,326 - 133,682 Research and development - - 189,179 189,179 Selling, general and administrative 238,810 147,213 - 386,023 Loss on disposition of assets 1,221 155 - 1,376 ------------ ------------------------ ------------- ------------- Total operating expenses 303,387 217,694 189,179 710,260 ------------ ------------------------ ------------- ------------- Operating income/(loss) 414,144 102,073 (189,179) 327,038 ------------ ------------------------ ------------- ------------- December 31, 2002 U.S. International R&D Total $'000 $'000 $'000 $'000 ------------ ------------- ------------- ------------- Total assets 818,383 1,340,116 50,124 2,208,623 Long lived assets 260,751 451,435 29,341 741,527 Capital expenditure on long lived assets 8,188 38,940 7,152 54,280 ------------ ------------- ------------- -------------
F-40 (22) Analysis of revenues, operating income/(loss) and assets by reportable segments (continued) Operating income/(loss) (continued)
Year ended December 31, 2001 U.S. International R&D Total $'000 $'000 $'000 $'000 ------------ ------------- ------------- ------------- Product sales 587,449 111,902 - 699,351 Licensing and development 4,507 991 - 5,498 Royalties 264 144,891 - 145,155 Other revenues - 2,952 - 2,952 Intersegment revenues 19,319 - 36,705 56,024 ------------ ------------------------ ------------- ------------- 611,539 260,736 36,705 908,980 Elimination of intersegment sales (19,319) - (36,705) (56,024) ------------ ------------------------ ------------- ------------- Total revenues 592,220 260,736 - 852,956 Cost of revenues 58,655 53,351 - 112,006 Research and development - - 171,029 171,029 Selling, general and administrative 195,438 108,042 - 303,480 Asset impairments and restructuring charges - 29,699 - 29,699 Merger transaction expenses - 83,470 - 83,470 Loss on disposition of assets 2,052 8,112 - 10,164 ------------ ------------------------ ------------- ------------- Total operating expenses 256,145 282,674 171,029 709,848 ------------ ------------------------ ------------- ------------- Operating income/(loss) 336,075 (21,938) (171,029) 143,108 ------------ ------------------------ ------------- ------------- December 31, 2001 U.S. International R&D Total $'000 $'000 $'000 $'000 ------------ ------------- ------------- ------------- Total assets 658,031 1,223,604 29,096 1,910,731 Long lived assets 327,289 419,601 23,286 770,176 Capital expenditure on long lived assets 3,880 65,558 2,488 71,926 ------------ ------------- ------------- -------------
F-41 (22) Analysis of revenues, operating income/(loss) and assets by reportable segments (continued) Operating income/(loss) (continued)
Year ended December 31, 2000 U.S. International R&D Total $'000 $'000 $'000 $'000 ------------ ------------- ------------- ------------- Product sales 391,168 105,607 - 496,775 Licensing and development 1,326 12,821 - 14,147 Royalties 266 135,204 - 135,470 Other revenues 20 1,242 - 1,262 Intersegment revenues 18,408 - 51,666 70,074 ------------ ------------------------ ------------- ------------- 411,188 254,874 51,666 717,728 Elimination of intersegment sales (18,408) - (51,666) (70,074) ------------ ------------------------ ------------- ------------- Total revenues 392,780 254,874 - 647,654 Cost of revenues 47,093 47,978 - 95,071 Research and development - - 155,145 155,145 Selling, general and administrative 116,761 113,455 - 230,216 Asset impairments and restructuring charges - 26,947 - 26,947 ------------ ------------------------ ------------- ------------- Total operating expenses 163,854 188,380 155,145 507,379 ------------ ------------------------ ------------- ------------- Operating income/(loss) 228,926 66,494 (155,145) 140,275 ------------ ------------------------ ------------- -------------
December 31, 2000 U.S. International R&D Total $'000 $'000 $'000 $'000 ------------ ------------- ------------- ------------- Total assets 560,864 943,687 43,944 1,548,495 Long lived assets 353,656 475,361 23,625 852,642 Capital expenditure on long lived assets 27,945 50,435 21,237 99,617 ------------ ------------- ------------- -------------
Material customers In the periods set out below, certain customers accounted for greater than 10% of Shire's total revenues:
Year ended December 31, 2002 2002 2001 2001 2000 2000 $'000 % revenue $'000 % revenue $'000 % revenue ----------- --------- ----------- --------- ----------- --------- Customer A 231,270 22% 176,941 21% 132,913 21% Customer B 197,184 19% 123,350 14% 80,293 12% Customer C 149,613 14% - - - - --------- --------- --------- ----------- ----------- -----------
Amounts outstanding at December 31, in respect of these material customers were as follows: December 31, 2002 2001 $'000 $'000 ----------- --------- Customer A 4,354 34,882 Customer B 9,189 39,094 Customer C 9,738 20,937 ----------- ----------- F-42 (23) Other charges Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 -------- -------- -------- In process research and development - - 26,947 Asset impairments and restructuring charges - 29,699 - Merger transaction expenses - 83,470 - Losses on disposition of assets 1,376 10,164 - -------- -------- -------- Year ended December 31, 2001 (a) BioChem merger The asset impairments and restructuring charges, merger transaction expenses and most of the losses on disposal of assets in 2001 related to the BioChem merger on May 11, 2001. The asset impairments and restructuring charges included an impairment charge of $20.9 million to adjust intangible asset values, primarily trademark and patent costs but also an element of product rights, to their estimated fair value. These charges are consistent with the Company's accounting policy to review periodically the carrying value of the intangibles and evaluate whether there has been any impairment in the value of those intangibles as compared with estimated undiscounted future cash flows relating to those intangibles. There was also a total of $8.8 million recorded in respect of employee related costs, as a result of employee terminations related to the closure of the Toronto facility and the elimination of duplicate positions across the combined organization. Shire's existing Canadian based sales and marketing operations in Toronto have been combined with those of BioChem in Laval. A total of 57 employees were identified to be terminated. As of December 31, 2001 all of the planned terminations were completed. The Company incurred a loss on the sale of a duplicated facility in Toronto, Canada of $8.1 million. (b) Product disposals During the third quarter of 2001, Shire disposed of certain non strategic products for net proceeds of approximately $4.5 million, recording a loss on disposition of $2.1 million. Year ended December 31, 2000 As a result of the merger with BioChem, the Company incurred a charge of $26.9 million relating to the acquisition of in process research and development in accordance with SFAS No. 2. (24) Other (expense)/income, net
Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- SERP valuation adjustment (2,301) (2,018) (607) Gain on sale of long-term investments - - 104,000 Write-down of long-term investments due to impairment (8,680) (55,748) - GeneChem funds income 3,333 3,995 6,773 Other (614) 838 (1,143) ----------- ----------- ----------- (8,262) (52,933) 109,023 ----------- ----------- -----------
F-43 (24) Other (expense)/income, net (continued) In 2001, the $55.7 million write down of investments related to the BioChem merger and comprised the write down of long-term unquoted investments ($24.9 million) and a write down of $30.8 million to a debenture held by BioChem, which was received on divestiture of its diagnostics subsidiary. These charges are consistent with the Company's policy to provide for other than temporary impairments in investment by reference to the fair value of the investment using established financial methodologies. The main components of other income in the year ended December 31, 2000 was a $104.0 million gain resulting from the sale of long-term investments, primarily in respect of North American Vaccine, Inc., a publicly traded biotechnology company listed on the American Stock Exchange. (25) Retirement benefits (a) Personal defined contribution pension plans The Company makes contributions to defined contribution retirement plans that together cover substantially all employees within the Group. For the defined contribution retirement plans, the level of company contribution is fixed at a set percentage of employee's pay. Company contributions to personal defined contribution pension plans totaled $6.8 million, $4.9 million and $2.6 million for the years ended December 31, 2002, 2001 and 2000 respectively, and were charged to operations as they became payable. (b) Defined benefit pension plan Roberts, a company with whom the Company merged in December 1999, operated a defined SERP for certain U.S. employees, which was established in 1998. This plan was available to former employees of Roberts who met certain age and service requirements. As part of the restructuring of the Group following the Roberts merger, the SERP was closed to new members and contributions ceased being paid into the plan for existing members. As part of this arrangement, the Company paid a lump sum contribution into the plan of $18.0 million, the result of which is that the Company has no future contributions under the plan. In accordance with EITF 97-14, the asset and liability of $12.1 million and $8.4 million respectively are shown on the balance sheet within the categories "Other non-current assets" and "Other non-current liabilities". See notes 13 and 17 above. (26) Income taxes The components of income before income taxes and equity in net income of associates for the years ended December 31 are as follows:
Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- U.K. (50,520) (101,756) (37,577) U.S. 218,139 190,068 70,700 Other jurisdictions 161,441 13,215 218,994 ----------- ----------- ----------- Income before income taxes, equity in net income of associates and extraordinary items attributable to continuing operations 329,060 101,527 252,117 ----------- ----------- ----------- Income before income taxes attributable to discontinued operations 9,696 10,711 11,083 ----------- ----------- ----------- Total income before income taxes and equity in net income of associates and extraordinary items 338,756 112,238 263,200 ----------- ----------- -----------
F-44 (26) Income taxes (continued) The provision for income taxes by location of the taxing jurisdiction for the years ended December 31, consisted of the following:
Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Current income taxes: U.K. corporation tax - - - U.S. federal tax (67,686) (40,818) (22,434) U.S. state and local taxes (9,561) (8,988) (2,744) Other jurisdictions (19,864) (17,862) (14,604) ----------- ----------- ----------- Total current taxes (97,111) (67,668) (39,782) ----------- ----------- ----------- Deferred taxes U.K. corporation tax - - - U.S. federal tax (1,136) (20,586) (4,268) U.S. state and local taxes (34) (618) (128) Other jurisdictions 9,931 19,975 614 ----------- ----------- ----------- Total deferred taxes 8,761 (1,229) (3,782) ----------- ----------- ----------- Total income taxes attributable to continuing operations (88,350) (68,897) (43,564) ----------- ----------- ----------- Total incomes taxes attributable to discontinued operations (4,812) (3,963) (4,100) ----------- ----------- ----------- Total income taxes (93,162) (72,860) (47,664) ----------- ----------- -----------
The reconciliation of income before income taxes, equity in net income of associates and extraordinary items attributing to continuing operations to provision for income taxes is shown in the table below.
Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 Income before income taxes, equity in net income of associates and extraordinary items attributing to continuing operations 329,060 101,527 252,117 ----------- ----------- ----------- Corporation tax rate 30% 30% 30% ----------- ----------- ----------- Income tax expense at corporation tax rate (98,718) (30,458) (75,635) Adjustments to derive effective rate: Non deductible items: Goodwill amortization - (3,309) (3,783) Permanent differences (4,280) (32,268) (963) Other items: Change in valuation allowance (13,948) (27,395) 8,238 Difference in taxation rates 36,450 27,662 33,181 Prior year adjustment (2,317) 2,958 (1,950) Other (5,537) (6,087) (2,652) ----------- ----------- ----------- Provision for income taxes on continuing operations (88,350) (68,897) (43,564) Provision for income taxes on discontinued operations (4,812) (3,963) (4,100) ----------- ----------- ----------- Provision for income taxes (93,162) (72,860) (47,664) ----------- ----------- -----------
The corporation tax rate of 30% is the tax rate of the parent company. F-45 (26) Income taxes (continued) The significant components of deferred income tax assets and liabilities and their balance sheet classifications, as of December 31, are as follows: December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Deferred tax assets: Accrued expenses not currently deductible 7,847 6,238 Losses carried forward 188,937 170,512 Provisions 5,347 7,874 Other 6,517 6,267 ------------ ----------- Gross deferred tax assets 208,648 190,891 Less: valuation allowance (139,513) (125,565) ------------ ----------- 69,135 65,326 Excess of tax value over book value of assets (28,070) (33,022) ------------ ----------- Net deferred tax assets 41,065 32,304 ------------ ----------- Balance sheet classifications: Continuing operations Deferred tax assets - current 34,849 19,430 Deferred tax assets - non-current 6,216 20,274 ------------ ----------- 41,065 39,704 Discontinued operations Deferred tax liability - non-current - (7,400) ------------ ----------- Net deferred tax assets 41,065 32,304 ------------ ----------- The approximate net operating loss carry-forwards as at December 31, are as follows:
December 31, December 31, 2002 2001 $'000 $'000 ------------ ----------- Approximate net operating loss carry-forwards against future U.S. federal tax liabilities 33,386 55,803 ------------ ----------- Approximate net operating loss carry-forwards against future U.S. state and foreign tax liabilities 639,756 470,177 ------------ ----------- Total 673,142 525,980 ------------ -----------
F-46 (26) Income taxes (continued) The tax losses shown above have the following expiration dates: December 31, 2002 $'000 ----------- 2003 - 2004 2,527 2005 30,362 2006 38,001 2007 20,731 2008 34,411 2009 27,245 Available indefinitely 519,865 ----------- 673,142 ----------- As of December 31, 2002, the Company had a valuation allowance of $139.5 million to reduce its deferred tax assets to estimated realizable value. The valuation allowance relates to the deferred tax assets arising from overseas tax operating loss carryforwards and capital loss carryforwards, which have no expiration date. The utilization of operating loss carryforwards is, however, restricted to the taxable income of the subsidiary generating the losses. In addition, capital loss carryforwards can only be offset against capital gains. As of December 31, 2002, based upon the level of historical taxable income and projections for future taxable income over the periods in which the temporary differences are anticipated to reverse, and prudent and feasible tax-planning strategies, management believes it is more likely than not that the Company will realize the benefits of these deductible differences, net of the valuation allowances. However, the amount of the deferred tax asset considered realizable could be adjusted in the future if estimates of taxable income are revised. The Company recognizes a deferred tax liability related to the undistributed earnings of subsidiaries when the Company expects that it will recover those undistributed earnings in a taxable manner, such as through receipt of dividends or sale of the investments. The Company does not, however, provide for income taxes on the unremitted earnings of certain other subsidiaries located outside the UK, where, in management's opinion, such earnings have been indefinitely reinvested in these operations, will be remitted in a tax free liquidation, or will be remitted as dividends with taxes substantially offset by foreign tax credits. (27) Equity method investees Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- GSK 2,592 1,985 - CADx/Qualia (924) - - North American Vaccine, Inc - - (3,809) ----------- ----------- ----------- 1,668 1,985 (3,809) ----------- ----------- ----------- The Company has accounted for its commercialization partnership with GSK (through which the products 3TC and ZEFFIX are marketed in Canada) using the equity method of accounting. The Company owns, but does not exercise control over, a 50% share of the partnership. In September 2002, the Company sold the net assets of its CADx group of companies, to Qualia Computing Inc, in exchange for shares in a newly formed joint venture. The Company has applied the equity method of accounting as the Company owns, but does not exercise control over, a 50% share of the new joint venture. F-47 (28) Stock incentive plans The Company has adopted the disclosure only provisions of SFAS No. 123., but applies APB No. 25 and related interpretations in accounting for its plans. In the years ended December 31, 2002, 2001 and 2000 the Company recognized a (credit)/charge under APB No. 25 of $(0.2) million, $2.3 million and $21.9 million respectively. Had compensation for stock options awarded under the plans been determined in accordance with SFAS No. 123, the Company's net income and per share data would have been changed to the pro forma amounts indicated below: Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Net income As reported 250,569 38,759 211,727 Pro forma 226,319 8,791 227,018 ----------- ----------- ----------- Income per share As reported - basic 50.0c 7.9c 43.8c As reported - diluted 49.0c 7.7c 42.8c Pro forma - basic 45.2c 1.8c 47.0c Pro forma - diluted 44.4c 1.7c 45.9c ----------- ----------- ----------- The fair value of stock options used to compute pro forma net income and per share disclosures is the estimated present value at grant date using the Black-Scholes option-pricing model with the following weighted average assumptions: Year ended December 31, 2002 2001 2000 $'000 $'000 $'000 ----------- ----------- ----------- Risk free interest rate 1.90 - 5.33% 3.43 - 5.22% 5.68 - 6.58% Expected dividend yield 0% 0% 0% Expected life 5 years 5 years 5 years Expected volatility 55.2% 59.5% 64.2% Directors and employees have been granted options over common shares under the following nine stock option plans: (i) Shire Holdings Limited Share Options Scheme (SHL Scheme) Options issued under the SHL Scheme were originally granted over shares in Shire Holdings Limited, a previous holding company of the Group. Exercise of these options results in the option holder receiving common shares in Shire. It is intended that no further options will be granted under the SHL Plan. (ii) Shire Pharmaceuticals Executive Share Option Scheme - Parts A and B (Executive Scheme) Options granted under the Executive Scheme are subject to performance criteria and cannot be exercised in full, unless the Company's share price increases at a compound rate of at least 20.5% per annum over a minimum three-year measurement period. If the Company's share price increases at a compound rate of 14.5% per annum over a minimum three-year measurement period, 60% of the options may be exercised. If these conditions are not met after the initial three years, they are thereafter tested quarterly by reference to share price growth over the extended period. If the share price does not meet these conditions at any time, none of the options will become exercisable. On February 28, 2000, the Remuneration Committee of the Board exercised its powers to amend the terms of the Executive Share Option Scheme so as to include a cliff vesting provision. It is intended that no further options will be granted under the Executive Scheme. F-48 (28) Stock incentive plans (continued) (iii) Shire Pharmaceuticals Group plc 2000 Executive Share Option Scheme (2000 Executive Scheme) Options granted under the 2000 Executive Scheme are subject to performance criteria and cannot be exercised in full unless the Company's share price increases at a compound rate of at least 20.5% per annum over a minimum three-year period. If the Company's share price increases at a compound rate of at least 14.5% per annum over a minimum three-year measurement period, 60% of the options will be exercisable. If these conditions are not met after the initial three-year measurement period, they will thereafter be tested quarterly by reference to compound annual share price growth over an extended period. If the share price does not meet these conditions at any time, none of these options will become exercisable. During 2002, the performance criteria was again reviewed to ensure the criteria reflected the market in which the Company operates. Given the Company's development it was felt appropriate that an earnings per share based measure should be adopted in place of share price growth targets. Therefore, the performance criteria was amended so that options will only become exercisable in full if the Company's EPS growth exceeds the U.K. Retail Prices Index (RPI) over at least a three-year period for the following tranches of grants: Options with a grant value of up to 100% of salary RPI plus 3% per annum Between 101% and 200% of salary RPI plus 5% per annum Between 201% and 300% of salary RPI plus 7% per annum The adoption of the new criteria applies to all options granted from August 2002 onwards. (iv) Shire Pharmaceuticals Sharesave Scheme (Sharesave Scheme) Options granted under the Sharesave Scheme are granted with an exercise price equal to 80% of the mid-market price on the day before invitations are issued to employees. Employees may enter into three or five-year savings contracts. (v) Shire Pharmaceuticals Group plc Employee Stock Purchase Plan (Stock Purchase Plan) Under the Stock Purchase Plan, options are granted with an exercise price equal to 85% of the fair market value of a share on the enrolment date (the first day of the offering period) or the exercise date (the last day of the offering period), whichever is the lower. The offering period is for 27 months. (vi) Pharmavene 1991 Stock Option Plan (SLI Plan) Options issued under the SLI Plan were originally granted over shares in SLI, formerly Pharmavene Inc., a company acquired by the Company on March 23, 1997. Exercise of these options results in the option holder receiving common shares in Shire. As a result of the acquisition of SLI, and in accordance with the terms of the original share option plan, all options granted under that plan became immediately capable of exercise. It is intended that no further options will be granted under the SLI Plan. (vii) Roberts Stock Option Plans (Roberts Plan) Options issued under the Roberts Plan were originally granted over shares in Roberts, a company acquired by the Company on December 23, 1999. Exercise of these options results in the option holder receiving common shares in Shire. As a result of the acquisition of Roberts, and in accordance with the terms of the original Roberts share option plan, all options granted under that plan became immediately capable of exercise. It is intended that no further options will be granted under the Roberts Plan. (viii) BioChem Stock Option Plan (BioChem Plan) Following the acquisition of BioChem Pharma, Inc. on May 11, 2001, the BioChem Stock Option Plan was amended such that options over BioChem's common stock became options over ordinary shares of Shire. All BioChem options, which were not already exercisable, vested and became exercisable as a result of the acquisition. It is intended that no further options will be granted under the BioChem Stock Option Plan. (ix) Richwood (SRI) Plan All options granted over shares in SRI, formerly Richwood Pharmaceutical Company Inc., a company acquired by the Group on 22 August 1997, have been exercised. Exercise of these options resulted in the optionholder receiving ordinary shares in the Company. As a result of the acquisition of SRI, and in accordance with the terms of the original share option plan, all options granted under the plan became immediately capable of exercise. It is intended that no further options will be granted under the SRI Plan. F-49 (28) Stock incentive plans (continued) In a period of ten years, not more than 10% of the issued share capital of Shire may be placed under option under any employee share scheme. In addition, the following terms apply to options that may be granted under the various plans: o 2000 Executive Scheme: the maximum number of shares over which incentive options may be granted under Part 3 of the scheme is 25,000,000. o Stock Purchase Plan: up to 2,000,000 common shares. Options outstanding at December 31, 2002 under the various plans are as follows:
Expiry period from Scheme Number of options date of issue Vesting period - ------------------------- ------------------ ---------------------- ---------------------- Executive Scheme 4,432,303 10 years 3 years, subject to performance criteria 2000 Executive Scheme 8,104,356 10 years 3 years, subject to performance criteria Sharesave Scheme 253,862 6 months after vesting 3 or 5 years Stock Purchase Plan 1,553,302 * 27 months SLI Plan 40,084 10 years Immediate on acquisition by Shire Roberts Plan 567,399 6 years Immediate on acquisition by Shire BioChem Plan 5,099,991 10 years Immediate on acquisition by Shire ------------------ Total 20,051,297 ------------------
* Options expire on the last day of the offering period. A summary of the status of the Company's stock option plans as of December 31, 2002, 2001 and 2000 and the related transactions during the periods then ended is presented below: Year ended December 31, 2002 Weighted average exercise price Number of $ shares --------------- ----------- Outstanding at beginning of period 10.80 16,249,844 Granted 8.49 6,179,894 Exercised 3.52 (1,940,546) Forfeited 11.07 (437,895) --------------- ----------- Outstanding at end of period 11.55 20,051,297 --------------- ----------- Exercisable at end of period 9.24 8,491,051 --------------- ----------- 4,539,529 options were granted under the 2000 Executive Scheme. These options were issued with exercise prices equivalent to the fair market value of the Company's common stock on the date of grant as these options were granted at market prices. F-50 (28) Stock incentive plans (continued) 186,052 options were granted under the Sharesave Scheme at a price of (pound)5.02 (approximately $8.08). These options were granted with an exercise price equal to 80% of the mid-market price on the day before invitations were issued to employees. 18,342 and 1,435,971 options were granted under the Stock Purchase Plan at a price of (pound)3.19 and (pound)5.44 (approximately $5.14 and $8.76) respectively. These options were granted with an exercise price equal to 85% of the mid-market price on the day before invitations were issued to employees. The average fair value of options granted in the year ended December 31, 2002 is $8.91. Year ended December 31, 2001 Weighted average exercise price Number of $ shares --------------- ----------- Outstanding at beginning of period 7.83 24,790,322 Granted 17.24 4,405,089 Exercised 6.29 (11,443,831) Forfeited 13.86 (1,501,736) --------------- ----------- Outstanding at end of period 10.80 16,249,844 --------------- ----------- Exercisable at end of period 7.50 9,054,150 --------------- ----------- All options granted under the Executive Scheme, 2000 Executive Scheme and BioChem Plan were issued with exercise prices equivalent to the fair market value of the Company's common stock on the date of grant as these options were granted at market prices. 81,888 options were granted under the Sharesave Scheme at a price of (pound)8.41 (approximately $12.24). These options were granted with an exercise price equal to 80% of the mid-market price on the day before invitations were issued to employees. 301,656, 120,819 and 6,551 options were granted under the Stock Purchase Plan at a price of (pound)8.06, (pound)9.10 and (pound)9.74 (approximately $11.73, $13.24 and $14.18) respectively. These options were granted with an exercise price equal to 85% of the mid-market price on the day before invitations were issued to employees. The average fair value of options granted in the year ended December 31, 2001 is $17.51. Year ended December 31, 2000 Weighted average exercise price Number of $ shares --------------- ----------- Outstanding at beginning of period 5.99 32,540,132 Granted 14.53 4,386,258 Exercised 4.30 (11,491,088) Forfeited 10.95 (644,980) --------------- ----------- Outstanding at end of period 7.83 24,790,322 --------------- ----------- Exercisable at end of period 6.84 13,385,095 --------------- ----------- All options granted under the Executive Scheme, 2000 Executive Scheme and BioChem Plan were issued with exercise prices equivalent to the fair market value of Shire's common stock on the date of grant as these options were granted at market prices. F-51 (28) Stock incentive plans (continued) 79,424 options were granted under the Sharesave Scheme at a price of (pound)8.56 (approximately $12.79). These options were granted with an exercise price equal to 80% of the mid-market price on the day before invitations were issued to employees. The average fair value of options granted in the year ended December 31, 2000 is $8.80. Options outstanding at December 31, 2002 have the following characteristics:
Weighted Weighted Weighted average Number of options average average exercise Number of options exercise price of outstanding Exercise prices remaining price of options exercisable options exercisable $ life outstanding ------------ -------------- ---------- --------------- ------------- ------------- 40,084 1.01 - 2.00 3.4 1.5 40,084 1.5 88,754 2.01 - 3.00 1.5 2.6 88,754 2.6 298,304 3.01 - 4.00 1.1 3.4 298,304 3.4 339,954 4.01 - 5.00 1.8 4.3 339,954 4.3 1,402,197 5.01 - 6.00 2.4 5.6 1,383,855 5.6 280,081 6.01 - 7.00 2.7 6.3 280,081 6.3 1,012,500 7.01 - 8.00 3.3 7.6 1,012,500 7.6 6,117,210 8.01 - 9.00 7.3 8.5 41,390 8.5 263,644 9.01 - 10.00 6.0 9.6 185,644 9.6 184,686 10.01 - 11.00 4.0 10.1 184,686 10.1 4,068,918 11.01 - 12.00 4.2 11.4 4,068,918 11.4 123,521 12.01 - 13.00 1.7 12.9 24,532 12.9 239,384 13.01 - 14.00 5.3 13.2 183,177 13.2 359,172 14.01 - 15.00 7.1 14.6 359,172 14.6 388,949 15.01 - 16.00 8.9 16.0 - - 1,513,829 16.01 - 17.00 4.5 16.5 - - 160,000 19.01 - 20.00 7.7 20.0 - - 3,166,110 20.01 - 21.00 8.2 20.3 - - 4,000 21.01 - 22.00 7.9 21.3 - - ---------- --------- 20,051,297 8,491,051 ---------- ---------
(29) Supplemental disclosure for non-cash transactions Immunogen share exchange In July 2002, the Company's $11.1 million preference share investment in Immunogen Inc. was converted in to a common stock holding. This continues to be included within investments (Note 10). Arenol loan note conversion In 1999 the Company financed the purchase of intellectual property relating to the manufacture of ADDERALL from Arenol Corporation by a total of $11.8 million in unsecured convertible zero coupon loan notes. On 6 August 2002, the Company issued the final instalment of 267,572 ordinary shares to Arenol Corporation in consideration of the conversion of the Loan Notes in the Company. Qualia Computing Inc. joint venture In September 2002, the Company sold the net assets of its CADx group of companies, to Qualia Computing Inc, in exchange for 50% of the common stock in the joint venture. The value of the assets in the CADx group of companies at the time of transfer was $9.3 million. F-52 Quarterly results of operations (unaudited) The following table presents summarized unaudited quarterly results for the years ended December 31, 2002 and 2001. The unaudited quarterly results for 2001 have been restated to reflect the merger with BioChem. The results for all quarterly periods presented have been restated to reflect the OTC divestment which has been accounted for as a discontinued operation.
2002 First Quarter Second Quarter Third Quarter Fourth Quarter $'000 $'000 $'000 $'000 ---------- ---------- ---------- ---------- Total revenues 236,982 248,084 249,720 302,512 Operating income 70,293 75,109 80,990 100,646 Net income 56,802 59,307 63,585 70,875 Earnings per share - basic 11.3c 11.8c 12.6c 14.1c ---------- ---------- ---------- ---------- Earnings per share - diluted 10.9c 11.4c 12.1c 13.8c ---------- ---------- ---------- ----------
2001 First Quarter Second Quarter Third Quarter Fourth Quarter $'000 $'000 $'000 $'000 ---------- ---------- ---------- ---------- Total revenues 180,397 202,486 209,752 260,321 Operating income 48,940 (56,398) 71,108 79,458 Net income/(loss) 41,465 (124,191) 58,111 63,374 Earnings per share - basic 8.4c (25.2)c 11.6c 12.7c ---------- ---------- ---------- ---------- Earnings per share - diluted 8.2c (24.6)c 11.3c 12.4c ---------- ---------- ---------- ----------
F-53 EXHIBIT INDEX Exhibit Description number 2 Merger Agreement, dated as of December 11, 2000, among BioChem Pharma Inc., 3829341 Canada Inc. and Shire Pharmaceuticals Group plc. (1) 3.1 Amended and Restated Memorandum and Articles of Association of Shire Finance Limited.(2) 3.2 Memorandum and Articles of Association of Shire.(3) 4.1 Deposit Agreement among Shire Pharmaceuticals Group plc, JP Morgan Chase Bank (f/k/a Morgan Guaranty Trust Company of New York) and Holders from time to time of Shire ADSs.(3) 4.2 Form of Ordinary Share Certificate.(3) 4.3 Form of ADR certificate (included within Exhibit 4.1).(3) 4.4 Indenture dated August 21, 2001 by and among Shire Finance Limited, Shire Pharmaceuticals Group plc and The Bank of New York, as Trustee.(2) 4.5 Form of 2% Senior Guaranteed Note due 2011 (included in Exhibit 4.4).(2) 4.6 Registration Rights Agreement dated August 21, 2001, between Shire Finance Limited, Shire Pharmaceuticals Group plc and Bear, Stearns International Limited and Goldman Sachs International, as representatives of the Initial Purchasers.(2) 4.7 Preference Share Guarantee Agreement dated August 21, 2001 among Shire Finance Limited, Shire Pharmaceuticals Group plc and The Bank of New York (f/k/a Morgan Guaranty Trust Company of New York), as Guarantee Trustee.(2) 4.8 Form of Shire Pharmaceuticals Group plc Guarantee.(2) 4.9 Form of Plan of Arrangement including Exchangeable provisions.(4) 4.10 Form of Voting and Exchange Trust Agreement.(4) 4.11 Form of Exchangeable Share Support Agreement.(4) 10.1 BioChem Pharma Inc. Directors, Officers, Employees and Consultant's Stock Option Plan, as amended.(5) 10.2 BioChem Pharma Inc. Deferred Share Unit Plan for Key Executives. (5) 10.3 BioChem Pharma Inc. Deferred Share Unit Plan for Non-Employee Directors. (5) 10.4 SHL Scheme.(3) 10.5 Executive Scheme 1996.(3) 10.6 Executive Scheme 2000. 10.7 Sharesave Scheme.(3) 10.8 Employee Stock Purchase Plan.(3) E-1 EXHIBIT INDEX (continued) Exhibit Description number 10.9 Revised and Restated Master License Agreement dated November 20, 1995 among Shire BioChem Inc (f/k/a BioChem Pharma Inc.), Glaxo Group Limited, Glaxo Wellcome Inc. (formerly Glaxo Canada Inc.), Glaxo Wellcome Inc. (formerly Glaxo Inc.), Tanaud Holdings (Barbados) Limited, Tanaud International B.V. and Tanaud LLC.(6) 10.10 Technology Partnership Canada, Development of Recombined Protein Vaccine Technologies Agreement, dated March 31, 2000 by and between the Canadian Government and Shire BioChem Inc (f/k/a BioChem Pharma Inc.). (6) 10.11 Service Agreement between Shire Pharmaceuticals Group plc and Mr Angus Russell, dated November 29, 2002. 10.12 Service Agreement between Shire Pharmaceuticals Group plc and Dr Wilson Totten, dated December 17, 2002. 16 Letter from Arthur Andersen regarding change in certifying accountant.(7) 21 List of Subsidiaries. 23.1 Consent of Deloitte & Touche 23.2 Consent of Raymond Chabot Grant Thornton. - -------------------------------------------------------------------------------- (1) Incorporated by reference to the exhibits to Shire's Form 8-K filed on December 11, 2000. (2) Incorporated by reference to the exhibits to Shire's Registration Statement on Form S-3 (No. 333-72862). (3) Incorporated by reference to the exhibits to Shire's Registration Statement on Form F-1 (No. 333-8394). (4) Incorporated by reference to the exhibits to Shire's Registration Statement on Form S-4 (No. 333-55696). (5) Incorporated by reference to the exhibits to Shire's Registration Statement on Form S-8 (No. 333-60952). (6) Incorporated by reference to the exhibits to BioChem's Form 20-F filed on June 9, 2000. (7) Incorporated by reference to the exhibit to Shire's Form 8-K filed on July 31, 2002. E-2 SIGNATURES Pursuant to the requirements of Section 13 of 15(d) of the Securities and Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. SHIRE PHARMACEUTICALS GROUP PLC (Registrant) Date: March 28, 2003 By: /s/ Matthew Emmens Matthew Emmens, Chief Executive Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the date indicated.
Signature Title Date - --------- ----- ---- /s/ James Henry Cavanaugh Non-executive Chairman March 28, 2003 ------------------------- JAMES HENRY CAVANAUGH /s/ Matthew Emmens Chief Executive March 28, 2003 ------------------ MATTHEW EMMENS /s/ Angus Charles Russell Group Finance Director March 28, 2003 ------------------------- ANGUS CHARLES RUSSELL /s/ Joseph Wilson Totten Group Research and Development Director March 28, 2003 ------------------------ JOSEPH WILSON TOTTEN /s/ Barry John Price Senior Non-executive Director March 28, 2003 -------------------- BARRY JOHN PRICE /s/ Ronald Maurice Nordmann Non-executive Director March 28, 2003 --------------------------- RONALD MAURICE NORDMANN Non-executive Director --------------------- FRANCESCO BELLINI /s/ James Andrew Grant Non-executive Director March 28, 2003 ---------------------- JAMES ANDREW GRANT /s/ Gerard Veilleux Non-executive Director March 28, 2003 ------------------- GERARD VEILLEUX /s/ David Mackney Group Financial Controller March 28, 2003 ----------------- DAVID MACKNEY
S-1 CERTIFICATION OF MATTHEW EMMENS PURSUANT TO RULE 13a-14 UNDER THE SECURITIES EXCHANGE ACT OF 1934 FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2002 OF Shire Pharmaceuticals Group PLC I, Matthew Emmens, certify that: 1. I have reviewed this annual report on Form 10-K of Shire Pharmaceuticals Group plc; 2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report; 3. Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report; 4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have: a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared; b) evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this annual report (the "Evaluation Date"); and c) presented in this annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; 5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent function): a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and 6. The registrant's other certifying officers and I have indicated in this annual report whether there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: March 28, 2003 /s/ Matthew Emmens ---------------------------- Matthew Emmens Chief Executive CERTIFICATION OF ANGUS RUSSELL PURSUANT TO RULE 13a-14 UNDER THE SECURITIES EXCHANGE ACT OF 1934 FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2002 OF Shire Pharmaceuticals Group PLC I, Angus Russell certify that: 1. I have reviewed this annual report on Form 10-K of Shire Pharmaceuticals Group plc; 2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report; 3. Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report; 4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have: a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared; b) evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this annual report (the "Evaluation Date"); and c) presented in this annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; 5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent function): a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and 6. The registrant's other certifying officers and I have indicated in this annual report whether there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: March 28, 2003 /s/ Angus Russell ------------------------------- Angus Russell Group Finance Director EX-10.6 3 shire10k033103ex106.txt RULES OF THE SHIRE PHARMACEUTICALS GROUP PLC 2000 EXECUTIVE SHARE OPTION SCHEME Adopted by the Company on 7 July 2000 Approved by the Inland Revenue on 12 September 2000 under reference X20983/DJT Arthur Andersen Abbots House Abbey Street Reading RG1 6SW Tel: 0118 950 8141 CONTENTS Page PART A Approved Options 1 1. Definitions 1 2. Grant of Options 6 3. Number of Shares in respect of which Options may be granted 8 4. Rights of exercise and lapse of Options 9 5. Take-over, reconstruction and winding-up 12 6. Manner of exercise 14 7. Issue or transfer of Shares 14 8. Adjustments 15 9. Administration 16 10. Alterations 17 11. Legal entitlement 18 12. General 19 PART B Unapproved Options 20 RULES OF THE SHIRE PHARMACEUTICALS GROUP PLC 2000 EXECUTIVE SHARE OPTION SCHEME PART A - Approved Options 1. DEFINITIONS 1.1 In this Scheme, the following words and expressions shall have, where the context so admits, the meanings set forth below: "Administrator" As determined by the Committee, either: (A) any third party administrator of the Scheme as duly appointed and authorised by the Committee; or (B) the Company; "Appropriate Period" The meaning given by Paragraph 15(2) of Schedule 9 to the Taxes Act. "Associated Company" In relation to the Company: (A) any company which has Control of the Company; and (B) any company which is under the Control of the Company or any company referred to in (A) above. "Auditors" The auditors of the Company for the time being or in the event of there being joint auditors such one of them as the Board shall select. "Board" The board of directors for the time being of the Company or a duly authorised committee thereof. "Close Company" A close company as defined in Section 414(1) of the Taxes Act as varied by Paragraph 8 of Schedule 9 to the Taxes Act. 1 The "Committee" Either: (A) In relation to the grant of Options to executivedirectors of the Company, the Remuneration Committee; or (B) in relation to the grant of Options to other employees, such other uly authorised committee of the Board as may be appointed from time to time. The "Company" Shire Pharmaceuticals Group plc (registered no. 02993758). "Control" The meaning given by Section 840 of the Taxes Act. "Daily Official List" The register of listed securities and the prices of transactions published by the London Stock Exchange. "Date of Grant" The date on which an Option is granted. "Dealing Day" Any day on which the London Stock Exchange is open for the transaction of business. "Eligible Employee" Any person who at the Date of Grant is: (A) an executive director of a Participating Company on terms which require him to devote not less than 25 hours per week (excluding meal breaks) to his duties; or (B) an employee of a Participating Company; and is not precluded by Paragraph 8 of Schedule 9 to the Taxes Act from participating in the Scheme; and is not within two years of his Retirement in accordancewith the terms of his contract of employment. "Employees' Share Scheme" The meaning given by Section 743 of the Companies Act 1985. 2 "Excess Shares" The aggregate number of Shares which were they to be acquired by an Eligible Employee on the exercise of any option would cause the limit specified in Rule 2.3 to be exceeded. "Executive Share Scheme" A share scheme in which participation is discretionary (for the avoidance of doubt, excluding any sharesave scheme or any employee stock purchase plan). "Exercise Price" The total amount payable in relation to the exercise of an Option, whether in whole or in part, being an amount equal to the relevant Option Price multiplied by the number of Shares in respect of which the Option is exercised. "Grantor" The Committee or the Trustees acting on the recommendation of the Committee. "Grant Period" The period of 42 days commencing on any of the following: (A) the day on which the Scheme is adopted by the Company. (B) the day on which the Scheme is approved by the Inland Revenue; (C) the day immediately following the day on which the Company makes an announcement of its results for the last preceding financial year, half-year or other period; (D) any day on which the Committee resolves that exceptional circumstances exist which justify the grant of Options; or (E) any day on which any change to the legislation affecting company share option schemes approved by the Inland Revenue under the Taxes Act is 3 proposed or made. "Group Member" A Participating Company or a body corporate which is (within the meaning of Section 736 of the Companies Act 1985) the Company's holding company or a Subsidiary of the Company's holding company or any other body corporate nominated by the Board for this purpose which is not under the control of any single person, but is under the control of two or more persons, one of whom being the Company or the Company's holding company and in relation to which the Company or, as the case may be, the Company's holding company is able (whether directly or indirectly) to exercise 20% or more of its equity voting rights. "London Stock Exchange" The London Stock Exchange Limited. "Market Value" In relation to a Share on any day: (A) if and so long as the Shares are listed on the London Stock Exchange, its middle market quotation (as derived from the Daily Official List on that day or if that day is not a Dealing Day then the Daily Official List for the most recent Dealing Day); (B) subject to (A) above, its market value, determined in accordance with Part VIII of the Taxation of Chargeable Gains Act 1992 and agreed in advance with the Inland Revenue. "Material Interest" The meaning given by Section 187(3) of the Taxes Act as extended at Paragraph 8 of Schedule 9 of the Taxes Act. "Member of a Consortium" The meaning given by Section 187(7) of the Taxes Act. "Option" A right to acquire Shares under the Scheme which is either subsisting or is proposed to be granted. 4 "Option Price" The price per Share, as determined by the Grantor, at which an Eligible Employee may acquire Shares upon the exercise of an Option granted to him being not less than the higher of: (A) the Market Value of a Share on the Date of Grant (or, if the Grantor determines, the average of the Market Values on the three Dealing Days immediately preceding the Date of Grant or the Market Value at such earlier time or times as may be determined by the Grantor and previously agreed in writing with the Inland Revenue); and (B) if the Shares are to be subscribed, their nominal value; but subject to any adjustment pursuant to Rule 8. "Part A" Means Part A of the Scheme; "Part B" Means Part B of the Scheme, being that part of the Scheme, which has not been approved by the Board of the Inland Revenue in accordance with Schedule 9 to the Taxes Act, in its present form or as from time to time amended in accordance with the provisions hereof. "Participant" Any Eligible Employee to whom an Option has been granted, or (where the context so admits) the personal representative of any such person. "Participating Company" (A) The Company; and (B) Any other company which is under the Control of the Company, is a Subsidiary of the Company and which has been expressly designated by the Board as being a Participating Company. "Retirement" Retirement on or after the Participant's normal retirement date (or such other date as the Committee may determine). 5 "Scheme" The Shire Pharmaceuticals Group plc 2000 Executive Share Option Scheme in its present form or as from time to time amended in accordance with the provisions hereof. "Share" A fully paid ordinary share in the capital of the Company which satisfies the requirements of Paragraphs 10 to 14 of Schedule 9 to the Taxes Act. "Subsidiary" The meaning given by Section 736 of the Companies Act 1985. "Taxes Act" The Income and Corporation Taxes Act 1988. "Trustees" The trustee or trustees for the time being of any employee benefit trust established for the benefit of beneficiaries including all or substantially all of the Eligible Employees. 1.2 Words and expressions not otherwise defined herein have the same meaning they have in the Taxes Act. 1.3 Where the context so admits or requires words importing the singular shall include the plural and vice versa and words importing the masculine shall include the feminine. 1.4 Reference in the rules of the Scheme to any statutory provisions are to those provisions as amended, extended or re-enacted from time to time, and shall include any regulations made thereunder. The Interpretation Act 1978 shall apply to these Rules on the same basis as if they were an Act of Parliament. 1.5 The headings in the rules of the Scheme are for the sake of convenience only and should be ignored when construing the rules. 2. GRANT OF OPTIONS 2.1 The Grantor may during a Grant Period grant Options at the Option Price to Eligible Employees at its absolute discretion. 6 2.2 The Grantor shall at the Date of Grant impose such condition or conditions on the exercise of an Option as determined by the Grantor. Such conditions: 2.2.1 must be objective and stated in writing at the Date of Grant; and 2.2.2 must not be waived, varied or amended by the Grantor unless in accordance with the terms of such conditions or, where any waiver, variation or amendment is at the discretion of the Grantor, it shall only be exercised in a manner which the Grantor has determined fair and reasonable and, if events happen which cause the Grantor, acting fairly and reasonably, to consider that the waived, varied or amended condition would be appropriate and would result in the waived, varied or amended condition being not substantially more or less difficult to satisfy than the condition as it existed immediately prior to such waiver, variation or amendment. 2.3 No Option shall be granted to an Eligible Employee at any time if it would result in: 2.3.1 the aggregate Market Value of the Shares which he may acquire in pursuance of rights obtained under the Scheme; and 2.3.2 the aggregate market value of shares which the Eligible Employee could acquire by the exercise of an Option under any other Executive Share Scheme approved under Schedule 9 to the Taxes Act and established by the Company or any Associated Company and not exercised exceeding (pound)30,000 or such other limit contained from time to time in Paragraph 28(1) of Schedule 9 to the Taxes Act. If an Option is granted over Excess Shares, the Grantor shall forthwith notify the Eligible Employee of this fact. The Grantor may call in the Option Certificate for endorsement, replacement or cancellation (as appropriate). If an Option is granted over Excess Shares, such Option shall only take effect to the extent that the aggregate market value of the shares (as calculated above) does not cause the above limit to be exceeded. 2.4 The grant of an Option shall be subject to obtaining any approval or consent required under any applicable laws, regulations of governmental authority and the requirements of the London Stock Exchange and any other securities exchange on which the Shares are traded. 2.5 As soon as practicable after grant, the Grantor shall issue to each Participant a duly executed certificate in respect of the Option in such form as the Grantor may from time to time prescribe. Such certificate must be sealed by the Grantor or executed as a deed on behalf of the Grantor and must state: 7 2.5.1 the number of Shares over which the Option has been granted to the Participant; 2.5.2 the Option Price; 2.5.3 the condition or conditions imposed pursuant to Rule 2.2 on the exercise of the Option; 2.5.4 the Date of Grant; and 2.5.5 the date on which the Option will lapse pursuant to Rule 4.4.1. 2.6 No payment to the Grantor shall be required on the grant of an Option. 2.7 Subject to the rights of exercise by the Participant's personal representatives pursuant to Rule 4.2, every Option shall be personal to the Participant to whom it is granted and shall not be transferable or in any way alienable. 2.8 A Participant may surrender his Option in whole or part within the period of 30 days immediately following the Date of Grant and if an Option, or any part of an Option is so surrendered, it shall be deemed for all purposes not to have been granted. 2.9 If an Eligible Employee's remuneration comprises either wholly or in part payments in a currency other than pounds sterling ("foreign currency"), for the purpose of calculating the maximum number of Shares which may be acquired pursuant to the exercise of Options under the Scheme, that foreign currency shall be converted into pounds sterling at the mid-market spot rate for that currency at the close of business published by the Financial Times on the Date of Grant, or if this is not a Dealing Day, the mid-market spot rate for that currency at the close of business published in the Financial Times on the next preceding Dealing Day. 3. NUMBER OF SHARES IN RESPECT OF WHICH OPTIONS MAY BE GRANTED 3.1 The number of Shares which may be allocated under the Scheme on any day shall not, when added to the aggregate of the number of Shares which have been allocated in the previous ten years under the Scheme and under any other Employees' Share Scheme (including a sharesave scheme or an employee stock purchase plan) adopted by the Company or any Subsidiary, exceed such number as represents ten per cent of the ordinary share capital of the Company in issue immediately prior to that day. 8 3.2 In determining the above limits: 3.2.1 any Shares issued or which may be issued to the Trustees to satisfy any Options which they have agreed to satisfy in accordance with Rule 2.1 shall be included; and 3.2.2 no account shall be taken of any Shares where the right to acquire such Shares was released or lapsed without being exercised, including pursuant to Rule 2.8 above. 3.3 References in this Rule to the "allocation" of Shares shall mean, in the case of any share option Scheme, the placing of unissued shares under option and, in relation to other types of Employees' Share Schemes, shall mean the issue and allotment of shares. 4. RIGHTS OF EXERCISE AND LAPSE OF OPTIONS 4.1 An Option: 4.1.1 save as provided in Rules 4.2, 4.3, 4.5 and 5 below shall not be exercised earlier than the third anniversary of the Date of Grant or such other later or earlier date as is determined by the Grantor at the Date of Grant; 4.1.2 save as provided in Rules 4.2, 4.3, 4.5 and 5 below, may only be exercised by a Participant whilst he is a director or employee of a Group Member; 4.1.3 other than when Options are exercised pursuant to Rules 4.2, 4.3 (with the exception of 4.3.2.3) and 5.5, may only be exercised if any conditions (as waived, varied or amended) imposed pursuant to Rule 2.2 have been fulfilled to the satisfaction of the Grantor. 4.1.4 may not be exercised at any time when a Participant has or has had within the preceding 12 months a Material Interest in a Close Company which is: 4.1.4.1 the Company; or 4.1.4.2 any company which has Control of the Company or is a Member of a Consortium which owns the Company; and 4.2 An Option may be exercised in the period of one year following the death of a Participant. 4.3 An Option may be exercised within the period which shall expire on the latest of : 9 4.3.1.1 twelve months following the date on which the Participant ceases to hold an office or employment with a Group Member; 4.3.1.2 42 months after the date of Grant; and 4.3.1.3 42 months after the date he last exercised an Option to which Section 185(3) of the Taxes Act applied, if such cessation is as a result of: 4.3.2.1 injury or disability; 4.3.2.2 redundancy within the meaning of the Employment Rights Act 1996; 4.3.2.3 Retirement; 4.3.2.4 early retirement by agreement with his employer; 4.3.2.5 the company which employs him ceasing to be a Group Member; 4.3.2.6 the transfer or sale of the undertaking or part-undertaking in which he is employed to a person who is not a Group Member; or 4.3.2.7 any other reason determined at the discretion of the Grantor within a period of time from ceasing to hold an office or employment with a Group Member as determined by the Grantor. For the purpose of this Rule 4.3.2.7, an Option will not be capable of being exercised prior to the Grantor exercising its discretion. For the purposes of Rule 4.3.1, a Participant shall not be treated as ceasing to be an employee or a director of a Group Member until such time as he is no longer a director or employee of any Group Member. 4.4 Options shall lapse upon the occurrence of the earliest of the following events: 4.4.1 the tenth anniversary of the Date of Grant; 4.4.2 the expiry of any of the periods specified in Rule 4.2 and 4.3 (save that if at the time any of the applicable periods under Rule 4.3 expire, time is running under the period in Rule 10 4.2, the Option shall not lapse by reason of this Rule 4.4.2 until the expiry of the period under Rule 4.2); 4.4.3 the expiry of any of the periods specified in Rules 5.1, 5.3, 5.4 and 5.5 save where an Option is released in consideration of the grant of a New Option (during one of the periods specified in Rules 5.1, 5.3 or 5.4) pursuant to Rule 5.6; 4.4.4 the Participant ceasing to hold an office or employment with a Group Member in any circumstances other than: 4.4.4.1 where the cessation of office or employment arises on any of the grounds specified in Rules 4.2 or 4.3 provided that an Option shall not be regarded as having lapsed pursuant to this Rule 4.4.4.1. if the Grantor determines within one month of the Participant ceasing to hold his office or employment that the Participant ceased to hold the office or employment in accordance with Rule 4.3.2.6; or 4.4.4.2 where the cessation of office or employment arises on any ground whatsoever during any of the periods specified in Rule 5 save where an Option is released in consideration of the grant of a New Option (during one of the periods specified in Rules 5.1, 5.3 or 5.4) pursuant to Rule 5.6; 4.4.5 subject to Rule 5.5, the passing of an effective resolution, or the making of an order by the Court, for the winding-up of the Company; 4.4.6 the Participant being deprived of the legal or beneficial ownership of the Option by operation of law, or doing or omitting to do anything which causes him to be so deprived or being declared bankrupt. 4.5 If a Participant, while continuing to hold an office or employment with a Group Member, is transferred to work in another country and as a result of that transfer the Participant will either: 4.5.1 become subject to income tax on his remuneration in the country to which he is transferred such that he will suffer a tax disadvantage upon exercising his Option; or 4.5.2 becomes subject to restrictions on his ability to exercise his Option or to deal in the Shares that may be acquired upon the exercise of that Option by reason of or in consequence of, the securities laws or exchange control laws of the country to which he is transferred; 11 the Participant may, at the discretion of the Grantor, exercise his Option in the period commencing three months before and ending three months after the transfer has taken place. 4.6 No Option may be granted, exercised, released or surrendered at a time when such grant, exercise, release or surrender would not be in accordance with the "Model Code on Directors' Dealings in Securities" issued by the London Stock Exchange as amended from time to time. 5. TAKEOVER, RECONSTRUCTION AND WINDING-UP 5.1 Subject to Rule 5.3 below, if any person obtains Control of the Company as a result of making, either: 5.1.1 a general offer to acquire the whole of the issued ordinary share capital of the Company (which is made on a condition such that if it is satisfied the person making the offer will have Control of the Company); or 5.1.2 a general offer to acquire all the shares in the Company which are of the same class as the Shares; the Committee shall within seven days of becoming aware thereof notify every Participant thereof and an Option may, provided that any exercise conditions imposed on the relevant Option pursuant to Rule 2.2 (as waived, varied or amended) have been fulfilled (or waived) to the satisfaction of the Grantor, be exercised within one month of the time when the person making the offer has obtained Control of the Company and any condition subject to which the offer is made has been satisfied. 5.2 For the purpose of Rule 5.1 a person shall be deemed to have obtained Control of the Company if he and others acting in concert (as defined by the City Code on Take-overs and Mergers) with him have together obtained Control of it. 5.3 If any person becomes bound or entitled to acquire Shares under Sections 428 to 430F of the Companies Act 1985 an Option may, provided that any exercise conditions imposed on the relevant Option pursuant to Rule 2.2 (as waived, varied or amended) have been fulfilled (or waived) to the satisfaction of the Grantor be exercised at any time when that person remains so bound or entitled. 5.4 If under Section 425 of the Companies Act 1985 it is proposed that the Court sanctions a compromise or arrangement proposed for the purposes of or in connection with a Scheme for 12 the reconstruction of the Company or its amalgamation with any other company or companies the Company shall give notice thereof to all Participants at the same time as it sends notices to members of the Company calling the meeting to consider such a compromise or arrangement. The Participant may then exercise the Option subject to the terms of this Rule before the earlier of the expiry of six months from the date of such notice and the date on which the Court sanctions the compromise or arrangement, provided that any exercise conditions imposed on the relevant Option pursuant to Rule 2.2 (as waived, varied or amended) have been fulfilled (or waived) to the satisfaction of the Grantor. The Option shall then lapse conditionally on such compromise or arrangement being sanctioned by the Court and becoming effective. The exercise of an Option under this Rule shall be conditional on such compromise or arrangement being sanctioned by the Court and becoming effective. After exercising the Option the Participant shall transfer or otherwise deal with the Shares issued to him so as to place him to the extent permitted by the Board in the same position (so far as possible) as would have been the case if such shares had been subject to such compromise or arrangement. 5.5 If notice is duly given of a resolution for the voluntary winding-up of the Company, the Company shall give notice thereof to all Participants. An Option may then be exercised until the resolution is duly passed or defeated or the meeting concluded or adjourned sine die provided that any such exercise of an Option pursuant to this Rule shall be conditional upon the said resolution being duly passed. If such resolution is duly passed all Options shall, to the extent that they have not been exercised, lapse immediately. 5.6 If Options become exercisable pursuant to any of Rules 5.1, 5.3 or 5.4 above and in the case of an Option becoming exercisable pursuant to Rule 5.4 provided that any company obtains Control in pursuance of the compromise or arrangement, any Participant may at any time within the Appropriate Period, by agreement with the relevant company, release any Option which has not lapsed ("the Old Option") in consideration of the grant to him of an Option ("the New Option") which (for the purposes of Paragraph 15 of Schedule 9 to the Taxes Act) is equivalent to the Old Option but relates to shares in a different company (whether the company which has obtained Control of the Company itself or some other company falling within Paragraph 10(b) or (c) of Schedule 9 to the Taxes Act). 5.7 The New Option shall not be regarded for the purposes of Rule 5.6 as equivalent to the Old Option unless the conditions set out in Paragraph 15(3) of Schedule 9 to the Taxes Act are satisfied but so that the provisions of the Scheme shall for this purpose be construed as if: 5.7.1 the New Option were an option granted under the Scheme at the same time as the Old Option; 13 5.7.2 except for the purpose of the definition of "Participating Company" in Rule 1 and the reference to "the Company" in Rule 10.2, the reference to Shire Pharmaceuticals Group plc in the definition of "the Company" in Rule 1 were a reference to the different company mentioned in Rule 5.6; and 5.7.3 all conditions imposed by Rule 2.2 have been satisfied. 6. MANNER OF EXERCISE 6.1 An Option may be exercised, in whole or in part provided always that until such time as the Board determines otherwise an Option may not be exercised in respect of less than 1,000 Shares unless, on the date of exercise, the Option is over less than 1,000 Shares. 6.2 An Option may be exercised by the delivery to the Administrator of an option certificate covering at least all the Shares over which the Option is then to be exercised, with the notice of exercise in the prescribed form duly completed and signed by the Participant (or by his duly authorised agent) together with a remittance for the Exercise Price payable to the Company (as agent for Trustees where the Trustees have agreed to satisfy the Option pursuant to Rule 2.1) in respect of the Shares over which the Option is to be exercised. If any conditions must be fulfilled before an Option may be exercised, the delivery of the certificate shall not be treated as effecting the exercise of an Option unless and until the Grantor is satisfied that the conditions have been fulfilled. The Grantor shall state whether the conditions have been fulfilled to its satisfaction as soon as practicable following the expiry of any performance period over which the fulfilment of conditions was to be measured or where a performance period is not relevant within 14 days of receipt of the documentation referred to above. 6.3 The effective date of exercise shall be the later of the date of delivery of the notice of exercise and the date that the Grantor states that the conditions imposed by Rule 2.2 have been fulfilled. For the purposes of this Scheme a notice of exercise shall be deemed to be delivered when it is received by the Administrator. 7. ISSUE OR TRANSFER OF SHARES 7.1 Subject to Rule 7.3, Shares to be issued pursuant to the exercise of an Option shall be allotted to the Participant (or his nominee) within 30 days following the date of effective exercise of the Option. 14 7.2 Subject to Rule 7.4, the Grantor shall procure the transfer of any Shares to be transferred to a Participant (or his nominee) pursuant to the exercise of an Option within 30 days following the date of effective exercise of the Option. 7.3 The allotment or transfer of any Shares under the Scheme shall be subject to obtaining any such approval or consent as is mentioned in Rule 2.5 above. 7.4 Shares issued pursuant to the Scheme will rank pari passu in all respects with the Shares then in issue, except that they shall not rank for any right attaching to Shares by reference to a record date preceding the date of exercise. 7.5 If Shares are transferred pursuant to the Scheme the Participant shall not be entitled to any rights attaching to Shares by reference to a record date preceding the date of exercise. 7.6 If and so long as the Shares are listed on the London Stock Exchange, the Company shall apply for listing of any Shares issued pursuant to the Scheme as soon as practicable after the allotment thereof. 8. ADJUSTMENTS 8.1 The number of Shares over which an Option is granted, the conditions of exercise and the Option Price thereof (and where an Option has been exercised but no Shares have been allotted or transferred pursuant to such exercise, the number of Shares which may be so allotted or transferred and the price at which they may be acquired) shall be adjusted in such manner as the Board shall determine following any capitalisation issue, any offer or invitation made by way of rights, subdivision, consolidation, reduction or other variation in the share capital of the Company which in the opinion of the Auditors justifies such an adjustment, to the intent that (as nearly as may be without involving fractions of a Share) the aggregate Exercise Price payable in respect of an Option shall remain unchanged provided that no adjustment shall be made pursuant to this Rule 8.1 without the prior approval of the Inland Revenue (so long as the Scheme is approved by the Inland Revenue). 8.2 Apart from pursuant to this Rule 8.2, no adjustment under Rule 8.1 above may have the effect of reducing the Option Price to less than the nominal value of a Share. Where an Option subsists over both issued and unissued Shares any such adjustment may only be made if the reduction of the Option Price of Options over both issued and unissued Shares can be made to the same extent. Any adjustment made to the Option Price of Options over unissued Shares shall only be made if and to the extent that the Board shall be authorised to capitalise from the reserves of the Company a sum equal to the amount by which the nominal value of the Shares 15 in respect of which the Option is exercisable exceeds the adjusted Exercise Price and to apply such sum in paying up such amount on such Shares so that on exercise of any Option in respect of which such a reduction shall have been made the Board shall capitalise such sum (if any) and apply the same in paying up such amount as aforesaid. 8.3 The Grantor may take such steps as it may consider necessary to notify Participants of any adjustment made under this Rule 8 and to call in, cancel, endorse, issue or reissue any certificate consequent upon such adjustment. 9. ADMINISTRATION 9.1 Any notice or other communication under or in connection with the Scheme may be given by personal delivery or by sending the same by post, in the case of a company to its registered office, and in the case of an individual to his last known address, or, where he is a director or employee of a Group Member, either to his last known address or to the address of the place of business at which he performs the whole or substantially the whole of the duties of his office or employment, and where a notice or other communication is given by post, it shall be deemed to have been received 72 hours after it was put into the post properly addressed and stamped. 9.2 The Company may distribute to Participants copies of any notice or document normally sent by the Company to the holders of Shares. 9.3 In the case of partial exercise of an Option, the Grantor may in consequence call in, endorse, cancel and reissue, as it considers appropriate, any certificate for the balance of the Shares over which the Option was granted. 9.4 If any certificate shall be worn out, defaced or lost, it may be replaced on such evidence being provided as the Grantor may require. 9.5 The Company shall at all times keep available for allotment unissued Shares at least sufficient to satisfy all Options under which Shares may be subscribed or the Grantor shall procure that sufficient Shares are available for transfer to satisfy all Options under which Shares may be acquired. 9.6 The Scheme shall be operated by the Board. The Board shall have full authority, consistent with the Scheme, to operate the Scheme, including authority to interpret and construe any provision of the Scheme and to adopt such regulations for administering the Scheme and such forms of exercise as it may deem necessary or appropriate. Decisions of the Board shall be final and binding on all parties. 16 9.7 The costs of introducing and administering the Scheme shall be borne by the Participating Companies. 10. ALTERATIONS 10.1 Subject to Rules 10.2 and 10.4, the Board may at any time (but only with the prior consent of the Trustees if there are subsisting Options which they have agreed to satisfy) alter or add to all or any of the provisions of the Scheme in any respect, provided that if an alteration or addition is made at a time when the Scheme is approved by the Inland Revenue under Schedule 9 to the Taxes Act it shall not have effect until it has been approved by the Inland Revenue. 10.2 Subject to Rule 10.3, no alteration or addition to the advantage of Participants or employees shall be made under Rule 10.1 without the prior approval by ordinary resolution of the members of the Company in general meeting. 10.3 Rule 10.2 shall not apply to any minor alteration or addition which is to benefit the administration of the Scheme, is necessary or desirable in order to obtain or maintain Inland Revenue approval of the Scheme under Schedule 9 to the Taxes Act or any other enactment or to take account of any change in legislation or to obtain or maintain favourable taxation, exchange control or regulatory treatment for the Company, or any Subsidiary of the Company or any Participant. 10.4 No alteration or addition shall be made under Rule 10.1 which would abrogate or adversely affect the subsisting rights of a Participant unless: 10.4.1 the Committee shall have invited every relevant participant to give an indication as to whether or not he approves the alteration or addition; and 10.4.2 the alteration or addition is approved by a majority of those Participants who have given such an indication, and for the purpose of this Rule 10.4 the provisions of the Articles of Association of the Company relating to shareholder meetings shall apply mutatis mutandis. 10.5 Notwithstanding any other provision of the Scheme other than Rule 10.1 the Board may, in respect of Options granted to Eligible Employees who are or who may become subject to taxation outside the United Kingdom on their remuneration amend or add to the provisions of the Scheme and the terms of Options as it considers necessary or desirable to take account of or 17 to mitigate or to comply with relevant overseas taxation, securities or exchange control laws provided that the rights attaching to Options granted to such Eligible Employees are clearly stated at the Date of Grant and will not be varied after the Date of Grant (otherwise than pursuant to Rules 10.1 to 10.4) and the terms are not overall more favourable than the terms of Options granted to other Eligible Employees. 10.6 As soon as reasonably practicable after making any alteration or addition under Rule 10.1, the Board shall give written notice thereof to any Participant materially affected thereby. 10.7 No alteration shall be made to the Scheme if following the alteration the Scheme would cease to be an Employees' Share Scheme. 11. LEGAL ENTITLEMENT 11.1 Nothing in the Scheme or in any instrument executed pursuant to it will confer on any person any right to continue in employment, nor will it affect the right of the provider of any service relationship to terminate the employment of any person without liability at any time with or without cause, nor will it impose upon the Board (or if so delegated, the Committee) or any other person any duty or liability whatsoever (whether in contract, tort or otherwise) in connection with: 11.1.1 the lapsing of any Option pursuant to the Scheme; 11.1.2 the failure or refusal to exercise any discretion under the Scheme; and/or 11.1.3 a Participant ceasing to be a person who has a service relationship for any reason whatever. 11.2 Options shall not (except as may be required by taxation law) form part of the emoluments of individuals or count as wages or remuneration for pension or other purposes. 11.3 Any person who ceases to have the status or relationship of an employee with any Group Member as a result of the termination of his employment for any reason and however that termination occurs, whether lawfully or otherwise, shall not be entitled and shall be deemed irrevocably to have waived any entitlement by way of damages for dismissal or by way of compensation for loss of office or employment or otherwise to any sum, damages or other benefits to compensate that person for the loss of alteration of any rights, benefits or expectations in relation to any Option, the Scheme or any instrument executed pursuant to it. 18 11.4 The benefit of this Rule 11 is given to the Company for itself and as trustee and agent of each Group Member. To the extent that this Rule benefits any company which is not a party to the Scheme, the benefit shall be held on trust and as agent by the Company for such company and the Company may, at its discretion, assign the benefit of this Rule 11 to any such company. 12. GENERAL 12.1 The Scheme shall terminate upon the tenth anniversary of its approval by the Company or at any earlier time by the passing of a resolution by the Board or an ordinary resolution of the Company in general meeting. Termination of the Scheme shall be without prejudice to the subsisting rights of Participants. 12.2 The Company and any Subsidiary of the Company may provide money to the trustees of any trust or any other person to enable them or him to acquire Shares to be held for the purposes of the Scheme, or enter into any guarantee or indemnity for those purposes, to the extent permitted by Section 153 of the Companies Act 1985. In addition, the Company may require any Subsidiary to enter into such other agreement or agreements as it shall deem necessary to oblige such Subsidiary to reimburse the Company for any other amounts paid by the Company hereunder, directly or indirectly in respect of such Subsidiary's employees. Nothing in the Scheme shall be deemed to give any employee of any Participating Company any right to participate in the Scheme. 12.3 These Rules shall be governed by and construed in accordance with the laws of England. 19 SHIRE PHARMACEUTICALS GROUP PLC 2000 SHARE OPTION SCHEME SCHEDULE I PART B - UNAPPROVED SCHEME 1.1. For the purpose of Options granted under this Schedule, all of the rules of the Scheme shall apply except that: 1.1.1 the definition of Share for these purposes shall be a fully paid ordinary share in the capital of the Company; 1.1.2 the definition of PAYE Liability shall be "the amount of all taxes and/or social security contributions payable by a Participant which a Participating Company, other Group Member or any other person (other than the Participant) (hereafter referred to as the "Relevant Payer") would be required to account for to the Inland Revenue or other taxation authority if a Participant exercised an Option"; 1.1.3 Rule 2.3 shall be deleted; 1.1.4 Rule 2.8 shall be amended so that Options may be transferred with the prior written agreement of the Board and such transfer shall be subject to such conditions as the Board may prescribe at that time; 1.1.5 References in the Rules of the Scheme to approval by the Inland Revenue shall be disregarded; 1.1.6 Rule 5.6 shall be amended so that the references to Paragraphs 15 and 10(b) or (c) of Schedule 9 to the Taxes Act are deleted; 1.1.7 Rule 5.7 shall be amended so that the reference to Paragraph 15(3) of Schedule 9 to the Taxes Act is deleted; 1.1.8 In the event that any PAYE Liability becomes due on the exercise of an Option, the Option may not be exercised unless: 1.1.8.1 the Relevant Payer is able to deduct an amount equal to the whole of the PAYE Liability from the Participant's net pay for the relevant pay period; or 1.1.8.2 the Participant has paid to the Relevant Payer an amount equal to the PAYE Liability; or 20 1.1.8.3 the Participant has given irrevocable instructions to the Company's brokers (or any other person acceptable to the Company) for the sale of sufficient Shares acquired on the exercise of the Option to realise an amount equal to the PAYE Liability and the payment of the PAYE Liability to the Relevant Payer; or 1.1.8.4 the Grantor determines otherwise. 1.1.9 The Grantor may make an adjustment in accordance with Rule 8 in the event of any demerger of the Company. 2.1 If the Committee so decides, this Rule 2 shall apply to any director or employee of a Participating Company who is, or may become, subject to taxation in the US. 2.2 In this Rule 2: 2.2.1 "Code" means the United States of America Internal Revenue Code of 1986 (as amended), 2.2.2 "ISO" means an incentive stock option within the meaning of section 422 of the Code except that an Option shall not be an incentive stock option if the option states that it is intended not to be incentive stock option, 2.2.3 "NQSO" means an option which is not an ISO; and 2.2.4 "US" means the United States of America. 2.3 The Committee may grant options which qualify as ISOs or as NQSOs; the Committee must state whether the option is to be an ISO or NQSO. 2.4 Where the Committee grants a person an Option which is to be an ISO, then: 2.4.1 it must be granted within 10 years after the date on which the Scheme is approved by shareholders or established by the Board, whichever is the earlier; 2.4.2 the price per share at which the Option may be exercised must not be less than an amount equal to the fair market value of a share on the Grant Date; 2.4.3 the option may not in any circumstances be exercised more than 10 years after its Grant Date; 2.4.4 to the extent required for "incentive stock option" treatment under the Code, the aggregate fair market value (determined as of the Grant Date) of the shares with respect 21 to which ISOs granted under this Scheme and any other Scheme or scheme of the Company or its "subsidiaries" or "parents" (a such terms are defined in Section 424 of the Code) become exercisable for the first time by a Participant during any calendar year shall not exceed $100,000; and 2.4.5 the option by its terms may not be transferable other than by will or the laws of descent and distribution, and it may be exercised, during the lifetime of the Participant, only by the Participant. 2.5 Subject to appropriate adjustment by the Board under the circumstances set forth in Rule 8.1, the maximum number of Shares with respect to which Options may be granted during any calendar year to any Participant under the Scheme shall be such number of Shares as represents ten per cent of the ordinary share capital of the Company in issue at the start of that calendar year. 2.6 Subject to appropriate adjustment by the Board under the circumstances set forth in Rule 8.1, the maximum number of shares over which ISOs may be granted under this rule 2 is 25,000,000. 22 EX-10.11 4 shire10k033103ex1011.txt THIS AGREEMENT is made the day of November 2002 B E T W E E N: (1) SHIRE PHARMACEUTICALS GROUP PLC (registered number 2883758) a company incorporated in and under the laws of England and Wales and having its registered office at Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP (the "Company"); and (2) MR ANGUS RUSSELL of High View, Monk's Well, Farnham, Surrey GU10 1RH (the "Executive"). WHEREBY it is agreed that the Company shall employ the Executive and the Executive shall serve the Company as Group Finance Director on the following terms and subject to the following conditions. 1. Commencement and Term 1.1 The Executive's continuous employment with the Company commenced on 13 December 1999. 1.2 The employment of the Executive shall (subject to the provisions of Clause 14) be terminable by either the Company or the Executive giving to the other 12 (twelve) months' notice in writing commencing at any time. 1.3.1 The Company may at its absolute discretion elect at any time to terminate the employment of the Executive with immediate effect by paying to the Executive (less deductions as appropriate) salary in lieu of notice and a sum (which shall be calculated by multiplying the Relevant Amount by the number of months' notice which the Executive was entitled to receive at the date of such termination) in compensation for the immediate loss by the Executive of his other benefits hereunder. 1.3.2 In the event that the Company terminates the employment of the Executive pursuant to Clause 1.3.1 at any time, the Relevant Amount shall be the aggregate of: (a) an amount equal to the maximum annual bonus to which, had he served his notice, the Executive would have been entitled pursuant to Clause 4 based on 100% achievement of group and personal objectives for the bonus year in which his employment terminates (based on the Executive's salary at the date on which his employment terminates), divided by 12 (twelve); and (b) (i) 25% of the Executive's basic salary (taken at the date of termination of this Agreement) in lieu of Company contributions to the Executive's pension scheme pursuant to Clause 6 of this Agreement, and 2 (ii) an amount equal to the actual cost to the Executive of providing the benefits due for the period of notice to the Executive pursuant to Clauses 7 and 8 of this Agreement, in each case divided by 12 (twelve). 2. Obligations during Employment 2.1 The Executive shall during the continuance of his employment: (a) serve the Company to the best of his ability in the capacity of Group Finance Director; (b) faithfully and diligently perform such duties and exercise such powers consistent with them as the Board may from time to time properly assign to or confer upon him in such capacity or otherwise in connection with the business of the Company or any Associated Company; (c) if and so long as the Board so directs perform and exercise the said duties and powers on behalf of any Associated Company and act as a director or other officer of any Associated Company; (d) do all in his power to protect, promote, develop and extend the business interests and reputation of the Group; (e) at all times and in all respects conform to and comply with the lawful and reasonable directions of the Board; (f) upon receiving reasonable notice promptly give to the Board (in writing if so requested) all such information, explanations and assistance as it may require in connection with the business and affairs of the Company and any Associated Company for which he is required to perform duties; (g) unless prevented by sickness, injury or other incapacity or as otherwise agreed by the Board devote the whole of his time, attention and abilities during his hours of work (which shall be normal business hours and such additional hours as may be necessary for the proper performance of his duties) to the business and affairs of the Company and any Associated Company for which he is required to perform duties; (h) work at the principal place of business of the Company at Chineham, Basingstoke, Hampshire or such other place of business of the Company or any Associated Company within 20 miles of Chineham as the Company may reasonably require for the proper performance and exercise of his duties and powers and the Executive may be required to travel on the business of the Company and any Associated Company for which he is required to perform duties; and 3 (i) comply with the Company's Code of Ethics Policy. 2.2 If the Company subsequently requires the Executive to work permanently at a place which is not within 20 miles of Chineham and which necessitates a move from his then address the Company will reimburse the Executive for all removal and associated expenses incurred as a result of the Company's requirement. 3. Further Obligations of the Executive 3.1 During the continuance of his employment the Executive shall devote his whole time and attention to his duties under this Agreement and shall not directly or indirectly carry on or be engaged, concerned or interested in any other business, trade or occupation otherwise than as a holder directly or through nominees (including for the purposes hereof through any trust whether established by the Executive or otherwise and whether discretionary or otherwise of which the Executive is a beneficiary) of not more than 3% in aggregate of any class of shares, debentures or other securities in issue from time to time of any company (or, if different, amounting to no more than 3% in terms of the economic value of all such shares and securities (whether by way of dividend or upon any return in capital) and/or voting or other rights attaching thereto in respect of any matters) which are for the time being quoted or dealt with on any recognised investment exchange (as defined by section 285(1)(a) of the Financial Services and Markets Act 2000) provided that nothing in this Clause 3.1 shall prevent the Executive from continuing to hold his current portfolio of investments in securities. 3.2 During the continuance of his employment the Executive shall in relation to any dealings in securities of overseas companies comply with all laws of any foreign state affecting dealings in the securities of such companies and all regulations of any relevant stock exchanges on which such dealings take place. 3.3 During the continuance of his employment the Executive: (a) shall not directly or indirectly procure, accept or obtain for his own benefit (or for the benefit of any other person) any payment, rebate, discount, commission, vouchers, gift, entertainment or other benefit from any third party in respect of any business transacted or proposed to be transacted (excluding air miles or similar vouchers from other such schemes) (whether or not by him) by or on behalf of the Company or any Associated Company ("Gratuities"); (b) shall observe the terms of any policy issued by the Company in relation to Gratuities; and (c) shall immediately disclose and account to the Company for any Gratuities received by him (or by any other person on his behalf or at his instruction). 4 4. Remuneration 4.1 The Company shall pay to the Executive during the continuance of his employment a basic salary (which shall accrue from day to day) at the rate of (pound)290,000 per year inclusive of any directors' fees payable to the Executive under the articles of association of the Company or any Associated Company (and any such fees as the Executive shall receive he shall pay to the Company). Basic salary with effect from 1 January 2003 will be (pound)320,000. The salary shall be payable by equal monthly instalments in arrears on the last day of each calendar month and shall be subject to review by the Remuneration Committee not less than annually with effect from 1 January in each year. 4.2 Subject as stated below the Executive shall be entitled to receive a bonus in accordance with the rules and terms of the Company's bonus scheme in force from time to time. Such bonus, if any, shall be subject to a maximum on target bonus of fifty per cent (50%) of the Executive's basic annual salary from time to time paid under Clause 4.1. Any additional bonus payable on an annual basis or for such other period as may be deemed appropriate shall be determined by the Remuneration Committee at its sole discretion and subject to a maximum bonus of seventy-five per cent (75%) of the Executive's basic annual salary under Clause 4.1. Any bonus payment shall be subject to deductions as appropriate. The Company reserves the right to change any bonus terms from year to year. 4.3 In the event that the Executive's employment hereunder terminates during any bonus year he shall be entitled to receive a proportion of the bonus he would have received had his employment not been terminated and the Remuneration Committee shall use its best endeavours but at its sole discretion to determine the estimation of such bonus. Such proportion shall be calculated as the fraction derived from dividing the period during which the Executive was employed hereunder during the relevant bonus year by the period of the bonus year. 5. Incentive Schemes If the Executive is at any time granted options pursuant to a share option scheme of the Company, those options shall be subject to the rules of that scheme as in force from time to time which rules shall not form part of the Executive's service agreement. In particular, if the Executive's employment should terminate for any reason (including as a result of a repudiatory breach of contract by the Company) he will not be entitled to any compensation for any loss of any right or benefit or prospective right or benefit under any such scheme which he may have enjoyed whether such compensation is claimed by way of damages for wrongful dismissal or other breach of contract or by way of compensation for loss of office or otherwise. 6. Pension Scheme 6.1 The Company shall contribute an amount equal to twenty-five per cent (25%) of the Executive's salary hereunder from time to time to such pension scheme as the Executive shall specify. Such contributions shall be made monthly at the date when 5 salary is paid hereunder. Such contributions shall be in addition to the Executive's basic salary. 6.2 No contracting-out certificate is in force in respect of the employment of the Executive. 7. Insurances Subject to his complying with and satisfying any applicable requirements of the relevant insurers the Company shall during the continuance of his employment: (a) provide for the Executive and his spouse and children under the age of 18 years membership of an appropriate private patient medical plan (to include cover for dental treatment) with such reputable medical expenses insurance scheme as the Company shall decide from time to time. The Executive shall be entitled to remain a member of such plan in accordance with and subject to its rules from time to time; (b) provide the Executive with life assurance cover which in the event of his death during the continuance of his employment may pay to his chosen dependants (subject only to the discretion of the trustees of the appropriate scheme) a lump sum equal to a minimum of 4 (four) times his then annual rate of salary. If such lump sum is more than the permitted maximum, such surplus to be made available (subject to the discretion of the trustees aforesaid) for the purchase of an annuity for the Executive's dependants subject as necessary to a medical examination. The Executive will co-operate with the Company in any way reasonably necessary in order for the Company to comply with its obligations thereunder including, without prejudice to the generality hereof, by submitting himself for such medical examination as may be required of him in connection therewith from time to time; (c) provide for the Executive membership at the cost of the Company of any permanent health care scheme and prolonged disability scheme operated by the Group for the benefit of executives. The Executive shall be entitled to remain a member of such scheme in accordance with and subject to its rules from time to time; and (d) provide Directors' and Officers' insurance cover for the benefit of the Executive under the same policy as will be provided for the other directors such cover to continue to cover the Executive in respect of acts or omissions committed during his employment hereunder whether claims are made during or within the period of 7 (seven) years after the termination of the employment hereunder. 8. Other Benefits 8.1 Subject to Clause 8.2 below the Company shall at the Executive's option provide the Executive with either: 6 8.1.1 a car of such make and model as the Remuneration Committee shall decide is suitable for him/compatible with his status in the Company (provided always that the leasing costs for such car shall not be more than (pound)800 per month (which shall increase in line with the retail price index during the Executive's employment hereunder) for his use and that of his spouse (if any) during the continuance of his employment in respect of which the Company shall pay or reimburse the Executive all business and reasonable private petrol and the standing and running costs together with all insurance and maintenance costs; or 8.1.2 the sum of (pound)10,560 per annum (payable in 12 (twelve) monthly instalments on the date the Executive's salary is paid less any deductions the Company is required to make by law) (which shall increase in line with the retail price index) to enable the Executive to purchase, maintain, comprehensively insure and tax a car for his use during the continuance of his employment, together with reimbursement of all business and reasonable private petrol and the standing and running costs together with all insurance and maintenance costs. No election may be made under this Clause 8.1.2 where a car has been provided under Clause 8.1.1 until the expiration of the lease term of the car in question. 8.2 The Executive shall at all times and in all respects conform to and comply with any policy which may from time to time be made by the Company and notified in writing to the Executive in relation to cars provided by it for the use of its employees and in particular the Executive: (a) shall ensure that at all times when the car is driven on a public highway it is in the state and condition required by law and that a current MOT test certificate is in force in respect of it (if appropriate); and (b) shall at all times be the holder of a current driving licence entitling him to drive motor cars in the United Kingdom and shall produce it to the Company upon request. 8.3 Where Clause 8.1.1 applies the Company shall replace the car with another of similar make and model at such intervals as the Remuneration Committee may in its discretion decide. 8.4 For the avoidance of doubt the Company shall be entitled at its absolute discretion to withdraw the use of the car provided pursuant to this Clause in circumstances reasonably provided for in the Company's car policy in force from time to time. 8.5 For all purposes connected with or relating to the employment of the Executive the benefit of the private use of the car(s) provided pursuant to this Agreement shall be calculated in accordance with the Inland Revenue rules in force from time to time. 7 8.6 The Executive shall take good care of the car and ensure that the provisions and conditions of any insurance policy relating to it are observed and shall return the car and its keys to the Company at its registered office (or any other place the Company may reasonably nominate) immediately upon the termination of his employment hereunder. 9. Expenses The Company shall during the continuance of his employment reimburse the Executive in respect of all reasonable travelling, accommodation and other similar out-of-pocket expenses properly incurred by him in or about the performance of his duties under this Agreement as approved by the Board provided that the Executive if so required by the Company provides reasonable evidence of any expenditure in respect of which reimbursement is claimed. 10. Holidays 10.1 The Executive shall (in addition to the usual public and bank holidays) be entitled during the continuance of his employment to 25 (twenty-five) working days' paid holiday in each holiday year, or such greater number in accordance with the Company's policy from time to time to be taken at a time or times as shall be convenient to the Company. 10.2 The Executive shall not be entitled to carry forward any annual holiday entitlement not taken by him for any reason from one holiday year to the next without the prior written consent of the Board (such consent not to be unreasonably withheld). 10.3 Upon the termination of his employment the Executive's entitlement to accrued holiday pay (which accrues at the rate of 2.08 days per month) shall be calculated on a pro rata basis in respect of each completed month of service in the holiday year in which his employment terminates and the appropriate amount shall be paid to the Executive in addition to payment in lieu for any holidays not taken in previous holiday years provided that if the Executive shall have taken more days holiday than his accrued entitlement the Company is hereby authorised to make an appropriate deduction from the Executive's final salary payment. 11. Incapacity 11.1 Subject to his complying with the Company's procedures relating to the notification and certification of periods of absence from work as from time to time in force the Executive shall continue to be paid his salary (inclusive of any statutory sick pay or social security benefits to which he may be entitled) during any periods of absence from work due to sickness, injury or other incapacity incapacitating the Executive from attending to his duties up to a maximum of 26 (twenty-six) weeks in aggregate in any period of 52 (fifty-two) consecutive weeks. 11.2 If the Executive shall have been absent from work due to sickness, injury or other incapacity for a continuous period of 26 (twenty-six) weeks or more then he shall 8 receive such benefits (if any) as are available to him under the terms of the Company's permanent health insurance scheme or such greater sum (if any) as the Board may in its absolute discretion decide. 11.3 If any incapacity of the Executive shall be or appear to be caused by any alleged action or wrong of a third party and the Executive shall decide to claim damages in respect thereof, then the Executive shall use all reasonable endeavours to recover damages for loss of earnings over the period for which salary has been or will be paid to him by the Company under Clause 11.1, and shall account to the Company for any such damages recovered (in an amount not exceeding the actual salary paid or payable to him by the Company under Clause 11.1 in respect of the said period) less any costs borne by him in achieving such recovery. The Executive shall keep the Company informed of the commencement, progress and outcome of any such claim. 12. Intellectual Property 12.1 For the purposes of this Clause 12 the term "IPRs" means any and all patents, trade and service marks, unregistered design rights, registered design rights, trade and business names, copyrights (including copyright in software), database rights, topography rights and all other intellectual property rights (whether or not any of these is registered and including applications for registration of any such thing) and all rights or forms of protection of a similar nature or having equivalent or similar effect to any of these which may subsist anywhere in the world. 12.2 If the Executive creates, makes, authors, originates, conceives or writes (either alone or with others) any works, designs, innovations, inventions, improvements, processes, get-ups or trade marks in the course of his employment with the Company ("Works"): (a) the Executive will promptly disclose to the Company full details of any such inventions, processes, improvements or other Works; (b) all rights (including, without limitation, all IPRs) in and to such Works shall solely legally and beneficially vest in the Company immediately upon their creation without any payment to the Executive; (c) the Executive hereby irrevocably and unconditionally waives, in favour of the Company, its licensees and successors-in-title any and all moral rights conferred on the Executive in relation to the Works (existing or future); and (d) the Executive shall not knowingly do anything, or omit to do anything, to imperil the validity of any patent or protection, or any application therefor, relating to any of the Works. 12.3 To the extent such rights and IPRs do not so vest in the Company, the Executive hereby (i) assigns to the Company all future copyright, database rights and unregistered design rights in the Works and (ii) in respect of all other rights and IPRs 9 agrees to assign to the Company all of the Executive's right, title and interest (including without limitation all IPRs) in the Works. 12.4 The Executive hereby irrevocably authorises the Company to be his attorney, and to make use of his name and to sign and execute any documents and/or perform any act on his behalf, for the purpose of giving to the Company the full benefit of the provisions of this Clause 12 and, where permissible, to obtain patent or other protection in respect of any of the Works in the name of the Company or the Company's nominee. 12.5 The Executive shall from time to time, both during his employment under this Agreement and thereafter, at the request and expense of the Company, promptly do all things and execute all documents necessary or desirable to give effect to the provisions of this Clause 12 including, without limitation, all things necessary to obtain and/or maintain patent or other protection in respect of any Works in any part of the world and to vest such rights (including, without limitation, all IPRs) in and to the Works in the Company or the Company's nominee. 12.6 For the avoidance of doubt, the provisions of this Clause 12 shall apply to any rights (including, without limitation, any IPRs) in the Works arising in any jurisdiction, and the provisions of this Clause 12 shall apply in respect of any jurisdiction to the extent permitted by the directives, statutes, regulations and other laws of any such jurisdiction. 13. Confidentiality 13.1 The Executive shall not (other than in the proper performance of his duties or without the prior written consent of the Board or unless ordered by a court of competent jurisdiction) at any time either during the continuance of his employment hereunder or after its termination disclose or communicate to any person or use for his own benefit or the benefit of any person other than the Company or any Associated Company any confidential information which may come to his knowledge in the course of his employment hereunder concerning the business or finances of any member of the Group or of any of its suppliers, agents, distributors or customers and the Executive shall during the continuance of his employment hereunder use his best endeavours (and following any termination thereof his reasonable endeavours) to prevent the unauthorised publication or misuse of any confidential information provided that such restrictions shall cease to apply to any confidential information which may enter the public domain other than through the default of the Executive but in any event the restrictions in this Clause 13.1 shall remain in full force and effect for so long as the Executive is in a position to utilise such information more readily than persons who have not been employed by the Company or its Associated Companies. 13.2 All notes and memoranda of any trade secret or confidential information concerning the business of the Company or the Associated Companies or any of its or their suppliers, agents, distributors, customers or others which shall have been acquired, received or made by the Executive during the course of his employment shall be the property of the Company and shall be surrendered by the Executive to someone duly 10 authorised in that behalf at the termination of his employment or at the request of the Board at any time during the course of his employment. 13.3 Without prejudice to the generality of Clause 13.1 the following is, for the avoidance of doubt, a non-exhaustive list of matters which in relation to the Company and the Associated Companies are considered confidential and must be treated as such by the Executive (for the purposes of this Agreement): (a) any trade secrets of the Company or any Associated Company; (b) any information in respect of which the Company or any Associated Company is bound by an obligation of confidence to any third party; (c) customer lists and details of contacts with or requirements of customers; and (d) any invention, technical data, know-how, instruction or operations manual or other manufacturing or trade secrets of the Group and/or their clients/customers. 13.4 The Executive shall comply with any reasonable policy produced by the Company concerning the Executive's ability to either directly or indirectly publish any opinion, fact or material or deliver any lecture or address or participate in the making of any film, radio broadcast or television transmission or communicate with any representative of the media or any third party relating to the business or affairs of the Company or any Associated Company or to any of its or their officers, employees, customers/clients, suppliers, distributors, agents or shareholders or to the development or exploitation of Works or IPRs (as defined in Clauses 12.1 and 12.2). For the purpose of this Clause "media" shall include television (terrestrial, satellite and cable) radio, newspapers and other journalistic publications. 14. Termination of Employment 14.1 The employment of the Executive may be terminated by the Board forthwith without notice or payment in lieu of notice if the Executive: (a) commits any serious or persistent breach or non-observance of any of the terms, conditions or stipulations contained in this Agreement having been, in the case of persistent breaches, warned in advance by the Board in writing of the same; (b) is guilty of any gross default or gross misconduct in connection with or affecting the business or affairs of the Company or any Associated Company for which he is required to perform duties; (c) is guilty of conduct which brings or is likely to bring himself or the Company or any Associated Company into disrepute; 11 (d) is convicted of an arrestable criminal offence (other than an offence under the road traffic legislation in the United Kingdom or elsewhere for which a non-custodial penalty is imposed); (e) is adjudged bankrupt or makes any arrangement or composition with his creditors or has an interim order made against him pursuant to section 252 of the Insolvency Act 1986; (f) becomes of unsound mind or becomes a patient under the Mental Health Act 1983; (g) is or becomes prohibited by law from being a director; or (h) voluntarily resigns as a director of the Company otherwise than at the request of the Board. 14.2 The employment of the Executive shall terminate automatically and without prior notice upon his attaining the age of 65. 14.3 Upon the termination of his employment (for whatever reason and howsoever arising) the Executive: (a) shall not take away, conceal or destroy but shall immediately deliver up to the Company all documents (which expression shall include but without limitation notes, memoranda, correspondence, drawings, sketches, plans, designs and any other material upon which data or information is recorded or stored) relating to the business or affairs of the Company or any Associated Company or any of their clients/customers, shareholders, employees, officers, suppliers, distributors and agents (and the Executive shall not be entitled to retain any copies or reproductions of any such documents) together with any other property belonging to the Company or any Associated Company (including his car and its keys) which may then be in his possession or under his control; (b) shall, at the request of the Board and without prejudice to any rights of the Executive arising as a result of the loss of his employment hereunder, immediately resign without claim for compensation from office as a director of the Company and any Associated Company and from any other office held by him in the Company or any Associated Company (but without prejudice to any claim he may have for damages for breach of this Agreement) and in the event of his failure to do so the Company is hereby irrevocably authorised to appoint some person in his name and on his behalf to sign and deliver such resignations to the Board and/or to each such Associated Company; (c) shall not at any time thereafter make any untrue or misleading oral or written statement concerning the business and affairs of the Company or any Associated Company nor represent himself or permit himself to be held out as being in any way connected with or interested in the business of the Company or any Associated Company (except as a former employee for the purpose of 12 communicating with prospective employers or complying with any applicable statutory requirements); (d) shall not at any time thereafter use the name "Shire" or any name capable of confusion therewith (whether by using such names as part of a corporate name or otherwise); and (e) shall immediately repay all outstanding debts or loans due to the Company or any Associated Company and the Company is hereby authorised to deduct from any wages (as defined by section 27 of the Employment Rights Act 1996) of the Executive a sum equal to any such debts or loans. 14.4 If the employment of the Executive under this Agreement is terminated by reason of the liquidation of the Company for the purpose of reconstruction or amalgamation or as part of any arrangement for the amalgamation or reconstruction of the Company not involving insolvency and the Executive is offered employment with any concern or undertaking resulting from the reconstruction or amalgamation on terms and conditions which taken as a whole are not less favourable than the terms of this Agreement then the Executive shall have no claim against the Company in respect of such termination. 15. Executive's Covenants 15.1 The Executive acknowledges that during the course of his employment with the Company he will receive and have access to confidential information of the Company and its Associated Companies (including without limitation those matters specified in Clause 13.3 of this Agreement) and he will also receive and have access to detailed client/customer lists and information relating to the operations and business requirements of those clients/customers and accordingly he is willing to enter into the covenants described in this Clause 15 in order to provide the Company and its Associated Companies with what he considers to be reasonable protection for those interests. 15.2 In this Clause 15: (a) "Restricted Business" means the Business of the Company and its Associated Companies at the time of the termination of the Executive's employment with which the Executive was involved to a material extent at any time during the period of 12 (twelve) months ending on the Restriction Date and for the purposes of this Clause the term "Business" shall mean the research, development, marketing, sale or supply of pharmaceuticals for administration to humans; (b) "Restricted Customer" means any firm, company or other person who, at any time during the period of 12 (twelve) months ending on the Restriction Date, was a customer of or in the habit of dealing with the Company or any Associated Company and with whom the Executive dealt to a material extent or for whom or which the Executive was responsible on behalf of the 13 Company or any Associated Company during that period and in respect of such customer material damage to the interests of the Company or any Associated Company could occur if such customer ceased or reduced its business with the Company or any Associated Company; (c) "Restricted Employee" means any person who, at the Restriction Date was employed by the Company or any Associated Company at a senior level and who could materially damage the interests of the Company or any Associated Company if he became employed in any business concern in competition with the Restricted Business and with whom the Executive worked closely or about whom the Executive obtained material detailed information, in either case at any time during the period of 12 (twelve) months ending on the Restriction Date; and (d) "Restriction Date" means the date of termination of this Agreement. 15.3 The Executive will not, for a period of 12 (twelve) months after the Restriction Date, solicit or endeavour to entice away from the Company or any Associated Company the business or custom of a Restricted Customer with a view to providing or receiving goods or services to or from that Restricted Customer in competition with any Restricted Business. 15.4 The Executive will not, for a period of 12 (twelve) months after the Restriction Date, provide goods or services to or otherwise have any business dealings with any Restricted Customer in the course of any business concern which is in competition with any Restricted Business. 15.5 The Executive will not, for a period of 12 (twelve) months after the Restriction Date, in the course of any business concern which is in competition with any Restricted Business offer employment to or otherwise endeavour to entice away from the Company or any Associated Company any Restricted Employee. 15.6 The Executive will not, without the prior written consent of the Board, for a period of 6 (six) months after the Restriction Date, be engaged in or concerned in any capacity in any business concern which is or might reasonably be expected to be in competition with any Restricted Business. This Clause shall not restrain the Executive from being engaged or concerned in any business concern in so far as the Executive's duties or work shall relate solely: (a) to geographical areas where the business concern is not in competition with the Restricted Business; or (b) to services or activities of a kind with which the Executive was not concerned to a material extent during the period of 12 (twelve) months ending on the Restriction Date. 14 15.7 The obligations imposed on the Executive by this Clause 15 extend to him acting not only on his own account but also on behalf of any other firm, company or other person and shall apply whether he acts directly or indirectly. 15.8 The Executive hereby agrees that he will at the request and expense of the Company enter into a direct agreement or undertaking with any Associated Company whereby he will accept restrictions and provisions corresponding to the restrictions and provisions in this Clause 15 (or such of them as may be appropriate in the circumstances) in relation to such activities and such area and for such a period not exceeding 12 (twelve) months as such Associated Company may reasonably require for the protection of its legitimate business interests. 15.9 It is agreed between the parties that whilst the restrictions set out in this Clause 15 are considered fair and reasonable for the protection of the Company's business and trade secrets, if it should be found that any of the restrictions be void as going beyond what is fair and reasonable in all the circumstances and if by deleting part of the wording or substituting a shorter period of time or different geographical limit or a more restricted range of activities for any of the period of time, geographical limits or ranges or activities set out in this Clause 15 it would not be void then there shall be substituted such next less extensive period and/or limit and/or activity or such deletions shall be made as shall render this Clause 15 valid and enforceable. 16. Change of Control 16.1 For the purposes of this Clause 16: (a) "Relevant Event" means either: (i) the termination by the Company of the Executive's employment (other than for cause in accordance with Clause 14 of this Agreement); or (ii) the Executive's resignation where such resignation is as a consequence of a repudiatory breach of contract by the Company and amounts to a constructive dismissal, within the period of 12 (twelve) months following the date of a Change of Control. (b) Subject to Clause 16.6 below "Change of Control" means where any person either alone or together with any person acting in concert with him obtains control of the Company as defined in section 840 of the Income and Corporation Taxes Act 1988. 16.2 If a Relevant Event occurs the Company shall pay to the Executive within 14 (fourteen) days of that Relevant Event a sum equal to the aggregate of: (a) the value of his then current rate of basic salary for the period of 2 (two) years; and 15 (b) an additional amount equal to 2 (two) times the annual bonus to which the Executive would have been entitled pursuant to Clause 4 based on an assumed 100% on target achievement of group and personal objectives in the year of the termination of his employment. 16.3 Subject to any rights accrued at the date of termination of the Executive's employment under the provisions of any pension scheme of the Company, any payment by the Company pursuant to this Clause 16 shall be made in full and final settlement of all and any claims arising from or in connection with the Executive's employment or its termination or his office as Group Finance Director and its loss in each case in respect of the Company or any Associated Companies. 16.4 All payments to be made pursuant to this Clause 16 shall be paid less any necessary withholdings. 16.5 The Executive hereby agrees that he shall not, following a payment under this Clause 16, bring any claim before any court or employment tribunal relating to unfair dismissal. 16.6 This Clause shall not apply where in connection with a scheme of reconstruction or amalgamation or reorganisation of the Company and one or more of its Associated Companies the Executive refuses an offer of employment on terms identical in all material respects to those hereunder by the company which following such reconstruction or reorganisation replaces the Company or the relevant Associated Companies. 17. Disciplinary and Grievance Procedures 17.1 The Executive shall be expected to maintain the highest standard of integrity and behaviour. For the purpose of disciplinary and grievance procedures the Executive's supervisor is the Company's Chief Executive. 17.2 If the Executive is not satisfied with any disciplinary decision taken in relation to him he may apply in writing within 14 (fourteen) days of that decision to the Board whose decision shall be final. 17.3 If the Executive has any grievance in relation to his employment he may raise it in writing with the Board whose decision shall be final. 17.4 If the Executive is not satisfied with any decision taken by the Chief Executive in relation to any grievance raised by him, he may apply in writing within 14 (fourteen) days of that decision, to the Board whose decision shall be final. 16 18. Directorship The Executive shall not save at the request or with the consent of the Board: (a) voluntarily resign as a director of the Company: (b) do or fail to do anything which causes him to be prohibited by law from continuing to act as a director; or (c) voluntarily do or refrain from doing any act whereby his office as a director of the Company is or becomes liable to be vacated. The removal of the Executive from office as a director of the Company or the failure of the Company in general meeting to re-elect the Executive as a director of the Company (if he shall be obliged to retire by rotation or otherwise pursuant to the Articles of Association) shall terminate the Executive's employment under this Agreement and such termination shall be without prejudice to any claim which the Executive may have for damages for breach of this Agreement provided that the Company was not entitled at the time of such removal or failure to re-elect to terminate his employment pursuant to Clause 14.1. 19. Data Protection The Executive consents to the Company or any Associated Company holding and processing both electronically and manually the data it collects which relates to the Executive for the purposes of the administration and management of its employees and its business and for compliance with applicable procedures, laws and regulations. The Executive also consents to the transfer of such personal information to other offices the Company may have or to an Associated Company or to other third parties whether or not outside the European Economic Area for administration purposes and other purposes in connection with the Executive's employment where it is necessary or desirable for the Company to do so. 20. Notices 20.1 Any notice to be given under this Agreement shall be given in writing and shall be deemed to be sufficiently served by one party on the other if it is delivered personally or is sent by first class registered or recorded delivery pre-paid post (air mail if overseas) addressed to either the Company's registered office for the time being or the Executive's address as set out in this Agreement (or such other address as shall be notified to the Company in accordance with this Clause) as the case may be. 20.2 Any notice sent by post shall be deemed (in the absence of evidence of earlier receipt) to be received 2 (two) days after posting (6 (six) if sent by air mail) and in proving the time such notice was sent and shall be sufficient to show that the envelope containing it was properly addressed, stamped and posted. Any notice delivered personally shall be deemed to be received when delivered to the address provided for in Clause 20.1. 17 21. Miscellaneous 21.1 The Executive hereby warrants that by virtue of entering into this Agreement he will not be in breach of any express or implied terms of any contract or of any other obligations legally binding upon him. 21.2 This Agreement supersedes the service agreement between the parties dated 29 October 1999 and the letter from the Company to the Executive dated 12 August 2002 which shall cease to have effect. 21.3 Any benefits provided by the Company to the Executive or his family which are not expressly referred to in this Agreement or the Letter of Offer shall be regarded as ex gratia benefits provided at the entire discretion of the Company and shall not form part of the Executive's contract of employment. 21.4 The Company shall be entitled at any time during the Executive's employment to make deductions from the Executive's salary or from any other sums due to the Executive from the Company or any Associated Company in respect of any overpayment of any kind made to the Executive or in respect of any debt or other sum due from him provided always that reasonable evidence of the validity of such deductions is provided to the Executive. 22. Definitions and Interpretation 22.1 In this Agreement: "Articles of Association" means the Company's articles of association in force at the date hereof and from time to time thereafter; "Associated Company" means a company which is from time to time a subsidiary or a holding company of the Company or a subsidiary (other than the Company) of a holding company of the Company. In this definition "subsidiary" and "holding company" have the same meaning as in section 736 of the Companies Act 1985; "Board" means the board of directors for the time being of the Company including any duly appointed committee thereof or the directors present at a meeting of the directors of the Company at which a quorum is present but excluding the Executive (as appropriate); "Group" means the Company and the Associated Companies; and 18 "Remuneration Committee" means the remuneration committee of the Board from time to time. 22.2 The headings in this Agreement are for convenience only and shall not affect its construction or interpretation. 22.3 References in this Agreement to Clauses are references to clauses in this Agreement. 22.4 Any reference in this Agreement to the employment of the Executive is a reference to his employment by the Company whether or not during the currency of this Agreement. 22.5 Any reference in this Agreement to a person shall where the context permits include a reference to a body corporate and to any unincorporated body of persons. 22.6 Any word in this Agreement which denotes the singular shall where the context permits include the plural and vice versa and any word in this Agreement which denotes the masculine gender shall where the context permits include the feminine and/or the neuter genders and vice versa. 22.7 Any reference in this Agreement to a statutory provision shall be deemed to include a reference to any statutory amendment, modification or re-enactment of it. 22.8 This Agreement is governed by and shall be construed in accordance with the laws of England and the parties to this Agreement hereby submit to the exclusive jurisdiction of the English courts. This Agreement supersedes all previous agreements of a similar nature between the parties or any Associated Company. IN WITNESS whereof this Agreement has been executed as a deed by the parties hereto and is intended and hereby delivered as a deed on the date first above written. Executed as a deed by ) SHIRE PHARMACEUTICALS ) GROUP PLC acting by a ) director and its secretary/ ) two directors: 19 Executed as a deed by ) ANGUS RUSSELL ) in the presence of: ) Signature of witness: ................................ Name: ................................ Address: ................................ ................................ ................................ Occupation: ................................ Dated [ ] November 2002 (1) SHIRE PHARMACEUTICALS GROUP PLC - and - (2) MR ANGUS RUSSELL - - - - - - - - - - - - - - - - - - - - - - - - SERVICE AGREEMENT - - - - - - - - - - - - - - - - - - - - - - - - EX-10.12 5 shire10k033103ex1012.txt THIS AGREEMENT is made the day of 2002 B E T W E E N: (1) SHIRE PHARMACEUTICALS GROUP PLC (registered number 2883758) a company incorporated in and under the laws of England and Wales and having its registered office at Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP (the "Company"); and (2) DR J W TOTTEN of Sycamore House, Tile Barn, Woolton Hill, Newbury, Berks RG20 9TF (the "Executive"). WHEREBY it is agreed that the Company shall employ the Executive and the Executive shall serve the Company as Group Research and Development Director on the following terms and subject to the following conditions. 1. Commencement and Term 1.1 The Executive's continuous employment with the Company commenced on 19 January 1998. 1.2 The employment of the Executive shall (subject to the provisions of Clause 14) be terminable by either the Company or the Executive giving to the other 12 (twelve) months' notice in writing commencing at any time. 1.3.1 The Company may at its absolute discretion elect at any time to terminate the employment of the Executive with immediate effect by paying to the Executive (less deductions as appropriate) salary in lieu of notice and a sum (which shall be calculated by multiplying the Relevant Amount by the number of months' notice which the Executive was entitled to receive at the date of such termination) in compensation for the immediate loss by the Executive of his other benefits hereunder. 1.3.2 In the event that the Company terminates the employment of the Executive pursuant to Clause 1.3.1 at any time, the Relevant Amount shall be the aggregate of: (a) an amount equal to the maximum annual bonus to which, had he served his notice, the Executive would have been entitled pursuant to Clause 4 based on 100% achievement of group and personal objectives for the bonus year in which his employment terminates (based on the Executive's salary at the date on which his employment terminates), divided by 12 (twelve); and (b) (i) 25% of the Executive's basic salary (taken at the date of termination of this Agreement) in lieu of Company contributions to the Executive's pension scheme pursuant to Clause 6 of this Agreement; and 2 (ii) an amount equal to the actual cost to the Executive of providing the benefits due for the period of notice to the Executive pursuant to Clauses 7 and 8 of this Agreement, in each case divided by 12 (twelve). 2. Obligations during Employment 2.1 The Executive shall during the continuance of his employment: (a) serve the Company to the best of his ability in the capacity of Group Research and Development Director; (b) faithfully and diligently perform such duties and exercise such powers consistent with them as the Board may from time to time properly assign to or confer upon him in such capacity or otherwise in connection with the business of the Company or any Associated Company; (c) if and so long as the Board so directs perform and exercise the said duties and powers on behalf of any Associated Company and act as a director or other officer of any Associated Company; (d) do all in his power to protect, promote, develop and extend the business interests and reputation of the Group; (e) at all times and in all respects conform to and comply with the lawful and reasonable directions of the Board; (f) promptly give to the Board (in writing if so requested) all such information explanations and assistance as it may require in connection with the business and affairs of the Company and any Associated Company for which he is required to perform duties; (g) unless prevented by sickness, injury or other incapacity or as otherwise agreed by the Board devote the whole of his time, attention and abilities during his hours of work (which shall be normal business hours and such additional hours as may be necessary for the proper performance of his duties) to the business and affairs of the Company and any Associated Company for which he is required to perform duties; (h) work at the principal place of business of the Company at Chineham, Basingstoke, Hampshire or such other place of business of the Company or any Associated Company within 20 miles of Chineham as the Company may reasonably require for the proper performance and exercise of his duties and powers and the Executive may be required to travel on the business of the Company and any Associated Company for which he is required to perform duties; and 3 (i) comply with the Company's Code of Ethics Policy. 2.2 If the Company subsequently requires the Executive to work permanently at a place which is not within 20 miles of Chineham and which necessitates a move from his then address the Company will reimburse the Executive for all removal and associated expenses incurred as a result of the Company's requirement. 3. Further Obligations of the Executive 3.1 During the continuance of his employment the Executive shall devote his whole time and attention to his duties under this Agreement and shall not directly or indirectly carry on or be engaged, concerned or interested in any other business, trade or occupation otherwise than as a holder directly or through nominees (including for the purposes hereof through any trust whether established by the Executive or otherwise and whether discretionary or otherwise of which the Executive is a beneficiary) of not more than 3% per cent in aggregate of any class of shares, debentures or other securities in issue from time to time of any company (or, if different, amounting to no more than 3% in terms of the economic value of all such shares and securities (whether by way of dividend or upon any return in capital) and/or voting or other rights attaching thereto in respect of any matters) which are for the time being quoted or dealt with on any recognised investment exchange (as defined by section 285(1)(a) of the Financial Services and Markets Act 2000) provided that nothing in this Clause 3.1 shall prevent the Executive from continuing to hold his current portfolio of investments in securities. 3.2 During the continuance of his employment the Executive shall in relation to any dealings in securities of overseas companies comply with all laws of any foreign state affecting dealings in the securities of such companies and all regulations of any relevant stock exchanges on which such dealings take place. 3.3 During the continuance of his employment the Executive: (a) shall not directly or indirectly procure, accept or obtain for his own benefit (or for the benefit of any other person) any payment, rebate, discount, commission, vouchers, gift, entertainment or other benefit from any third party in respect of any business transacted or proposed to be transacted (excluding air miles or similar vouchers from other such schemes) (whether or not by him) by or on behalf of the Company or any Associated Company ("Gratuities"); (b) shall observe the terms of any policy issued by the Company in relation to Gratuities; and (c) shall immediately disclose and account to the Company for any Gratuities received by him (or by any other person on his behalf or at his instruction). 4 4. Remuneration 4.1 The Company shall pay to the Executive during the continuance of his employment a basic salary (which shall accrue from day to day) at the rate of (pound)310,000 per year inclusive of any directors' fees payable to the Executive under the articles of association of the Company or any Associated Company (and any such fees as the Executive shall receive he shall pay to the Company). Basic salary with effect from 1 January 2003 will be (pound)340,000. The salary shall be payable by equal monthly instalments in arrears on the last day of each calendar month and shall be subject to review by the Remuneration Committee not less than annually with effect from 1 January in each year. 4.2 Subject as stated below the Executive shall be entitled to receive a bonus in accordance with the rules and terms of the Company's bonus scheme in force from time to time. Such bonus, if any, shall be subject to a maximum on target bonus of fifty per cent (50%) of the Executive's basic annual salary from time to time paid under Clause 4.1 above. Any additional bonus payable on an annual basis or for such other period as may be deemed appropriate shall be determined by the Remuneration Committee at its sole discretion and subject to a maximum bonus of seventy-five per cent (75%) of the Executive's basic annual salary under Clause 4.1. Any bonus payment shall be subject to deductions as appropriate. The Company reserves the right to change any bonus terms from year to year. 4.3 In the event that the Executive's employment hereunder terminates during any bonus year he shall be entitled to receive a proportion of the bonus he would have received had his employment not been terminated and the Remuneration Committee shall use its best endeavours but at its sole discretion to determine the estimation of such bonus. Such proportion shall be calculated as the fraction derived from dividing the period during which the Executive was employed hereunder during the relevant bonus year by the period of the bonus year. 5. Incentive Schemes If the Executive is at any time granted options pursuant to a share option scheme of the Company, those options shall be subject to the rules of that scheme as in force from time to time which rules shall not form part of the Executive's service agreement. In particular, if the Executive's employment should terminate for any reason (including as a result of a repudiatory breach of contract by the Company) he will not be entitled to any compensation for any loss of any right or benefit or prospective right or benefit under any such scheme which he may have enjoyed whether such compensation is claimed by way of damages for wrongful dismissal or other breach of contract or by way of compensation for loss of office or otherwise. 6. Pension Scheme 6.1 The Company shall contribute an amount equal to 25% of the Executive's salary hereunder from time to time to such pension scheme as the Executive shall specify. 5 Such contributions shall be made monthly at the date when salary is paid hereunder. Such contributions shall be in addition to the Executive's basic salary. 6.2 No contracting-out certificate is in force in respect of the employment of the Executive. 7. Insurances Subject to his complying with and satisfying any applicable requirements of the relevant insurers the Company shall during the continuance of his employment: (a) provide for the Executive and his spouse and children under the age of 18 years membership of an appropriate private patient medical plan (to include cover for dental treatment) with such reputable medical expenses insurance scheme as the Company shall decide from time to time. The Executive shall be entitled to remain a member of such plan in accordance with and subject to its rules from time to time; (b) provide the Executive with life assurance cover which in the event of his death during the continuance of his employment may pay to his chosen dependants (subject only to the discretion of the trustees of the appropriate scheme) a lump sum equal to a minimum of 4 (four) times his then annual rate of salary. If such lump sum is more than the permitted maximum, such surplus to be made available (subject to the discretion of the trustees aforesaid) for the purchase of an annuity for the Executive's dependants subject as necessary to a medical examination. The Executive will co-operate with the Company in any way reasonably necessary in order for the Company to comply with its obligations thereunder including, without prejudice to the generality hereof, by submitting himself for such medical examination as may be required of him in connection therewith from time to time; (c) provide for the Executive membership at the cost of the Company of any permanent health care scheme and prolonged disability scheme operated by the Group for the benefit of executives. The Executive shall be entitled to remain a member of such scheme in accordance with and subject to its rules from time to time; and (d) provide Directors' and Officers' insurance cover for the benefit of the Executive under the same policy as will be provided for the other directors such cover to continue to cover the Executive in respect of acts or omissions committed during his employment hereunder whether claims are made during or within the period of 7 (seven) years after the termination of the employment hereunder. 8. Other Benefits 8.1 Subject to clause 8.2 below the Company shall at the Executive's option provide the Executive with either: 6 8.1.1 a car of such make and model as the Remuneration Committee shall decide is suitable for him/compatible with his status in the Company (provided always that the leasing costs for such car shall not be more than (pound)800 per month (which shall increase in line with the retail price index during the Executive's employment hereunder) for his use and that of his spouse (if any) during the continuance of his employment in respect of which the Company shall pay or reimburse the Executive all business and reasonable private petrol and the standing and running costs together with all insurance and maintenance costs; or 8.1.2 the sum of(pound)10,560 per annum (payable in 12 (twelve) monthly instalments on the date the Executive's salary is paid less any deductions the Company is required to make by law) (which shall increase in line with the retail price index) to enable the Executive to purchase, maintain, comprehensively insure and tax a car for his use during the continuance of his employment, together with reimbursement of all business and reasonable private petrol and the standing and running costs together with all insurance and maintenance costs. No election may be made under this Clause 8.1.2 where a car has been provided under Clause 8.1.1 until the expiration of the lease term of the car in question. 8.2 The Executive shall at all times and in all respects conform to and comply with any policy which may from time to time be made by the Company and notified in writing to the Executive in relation to cars provided by it for the use of its employees and in particular the Executive: (a) shall ensure that at all times when the car is driven on a public highway it is in the state and condition required by law and that a current MOT test certificate is in force in respect of it (if appropriate); and (b) shall at all times be the holder of a current driving licence entitling him to drive motor cars in the United Kingdom and shall produce it to the Company upon request. 8.3 Where Clause 8.1.1 applies the Company shall replace the car with another of similar make and model at such intervals as the Remuneration Committee may in its discretion decide. 8.4 For the avoidance of doubt the Company shall be entitled at its absolute discretion to withdraw the use of the car provided pursuant to this Clause in circumstances reasonably provided for in the Company's car policy in force from time to time. 7 8.5 For all purposes connected with or relating to the employment of the Executive the benefit of the private use of the car(s) provided pursuant to this Agreement shall be calculated in accordance with the Inland Revenue rules in force from time to time. 8.6 The Executive shall take good care of the car and ensure that the provisions and conditions of any insurance policy relating to it are observed and shall return the car and its keys to the Company at its registered office (or any other place the Company may reasonably nominate) immediately upon the termination of his employment hereunder. 9. Expenses The Company shall during the continuance of his employment reimburse the Executive in respect of all reasonable travelling, accommodation and other similar out-of-pocket expenses properly incurred by him in or about the performance of his duties under this Agreement as approved by the Board provided that the Executive if so required by the Company provides reasonable evidence of any expenditure in respect of which reimbursement is claimed. 10. Holidays 10.1 The Executive shall (in addition to the usual public and bank holidays) be entitled during the continuance of his employment to 25 (twenty-five) working days' paid holiday in each holiday year, or such greater number in accordance with the Company's policy from time to time to be taken at a time or times as shall be convenient to the Company. 10.2 The Executive shall not be entitled to carry forward any annual holiday entitlement not taken by him for any reason from one holiday year to the next without the prior written consent of the Board (such consent not to be unreasonably withheld). 10.3 Upon the termination of his employment the Executive's entitlement to accrued holiday pay (which accrues at the rate of 2.08 days per month) shall be calculated on a pro rata basis in respect of each completed month of service in the holiday year in which his employment terminates and the appropriate amount shall be paid to the Executive in addition to payment in lieu for any holidays not taken in previous holiday years provided that if the Executive shall have taken more days holiday than his accrued entitlement the Company is hereby authorised to make an appropriate deduction from the Executive's final salary payment. 11. Incapacity 11.1 Subject to his complying with the Company's procedures relating to the notification and certification of periods of absence from work as from time to time in force the Executive shall continue to be paid his salary (inclusive of any statutory sick pay or social security benefits to which he may be entitled) during any periods of absence from work due to sickness, injury or other incapacity incapacitating the Executive from attending to his duties up to a maximum of 26 (twenty-six) weeks in aggregate in any period of 52 (fifty-two) consecutive weeks. 11.2 If the Executive shall have been absent from work due to sickness, injury or other incapacity for a continuous period of 26 (twenty-six) weeks or more then he shall 8 receive such benefits (if any) as are available to him under the terms of the Company's permanent health insurance scheme or such greater sum (if any) as the Board may in its absolute discretion decide. 11.3 If any incapacity of the Executive shall be or appear to be caused by any alleged action or wrong of a third party and the Executive shall decide to claim damages in respect thereof, then the Executive shall use all reasonable endeavours to recover damages for loss of earnings over the period for which salary has been or will be paid to him by the Company under Clause 11.1, and shall account to the Company for any such damages recovered (in an amount not exceeding the actual salary paid or payable to him by the Company under Clause 11.1 in respect of the said period) less any costs borne by him in achieving such recovery. The Executive shall keep the Company informed of the commencement, progress and outcome of any such claim. 12. Intellectual Property 12.1 For the purposes of this Clause 12 the term "IPRs" means any and all patents, trade and service marks, unregistered design rights, registered design rights, trade and business names, copyrights (including copyright in software), database rights, topography rights and all other intellectual property rights (whether or not any of these is registered and including applications for registration of any such thing) and all rights or forms of protection of a similar nature or having equivalent or similar effect to any of these which may subsist anywhere in the world. 12.2 If the Executive creates, makes, authors, originates, conceives or writes (either alone or with others) any works, designs, innovations, inventions, improvements, processes, get-ups or trade marks in the course of his employment with the Company ("Works"): (a) the Executive will promptly disclose to the Company full details of any such inventions, processes, improvements or other Works; (b) all rights (including, without limitation, all IPRs) in and to such Works shall solely legally and beneficially vest in the Company immediately upon their creation without any payment to the Executive; (c) the Executive hereby irrevocably and unconditionally waives, in favour of the Company, its licensees and successors-in-title any and all moral rights conferred on the Executive in relation to the Works (existing or future); and (d) the Executive shall not knowingly do anything, or omit to do anything, to imperil the validity of any patent or protection, or any application therefor, relating to any of the Works. 12.3 To the extent such rights and IPRs do not so vest in the Company, the Executive hereby (i) assigns to the Company all future copyright, database rights and unregistered design rights in the Works and (ii) in respect of all other rights and IPRs 9 agrees to assign to the Company all of the Executive's right, title and interest (including without limitation all IPRs) in the Works. 12.4 The Executive hereby irrevocably authorises the Company to be his attorney, and to make use of his name and to sign and execute any documents and/or perform any act on his behalf, for the purpose of giving to the Company the full benefit of the provisions of this Clause 12 and, where permissible, to obtain patent or other protection in respect of any of the Works in the name of the Company or the Company's nominee. 12.5 The Executive shall from time to time, both during his employment under this Agreement and thereafter, at the request and expense of the Company, promptly do all things and execute all documents necessary or desirable to give effect to the provisions of this Clause 12 including, without limitation, all things necessary to obtain and/or maintain patent or other protection in respect of any Works in any part of the world and to vest such rights (including, without limitation, all IPRs) in and to the Works in the Company or the Company's nominee. 12.6 For the avoidance of doubt, the provisions of this Clause 12 shall apply to any rights (including, without limitation, any IPRs) in the Works arising in any jurisdiction, and the provisions of this Clause 12 shall apply in respect of any jurisdiction to the extent permitted by the directives, statutes, regulations and other laws of any such jurisdiction. 13. Confidentiality 13.1 The Executive shall not (other than in the proper performance of his duties or without the prior written consent of the Board or unless ordered by a court of competent jurisdiction) at any time either during the continuance of his employment hereunder or after its termination disclose or communicate to any person or use for his own benefit or the benefit of any person other than the Company or any Associated Company any confidential information which may come to his knowledge in the course of his employment hereunder concerning the business or finances of any member of the Group or of any of its suppliers, agents, distributors or customers and the Executive shall during the continuance of his employment hereunder use his best endeavours (and following any termination thereof his reasonable endeavours) to prevent the unauthorised publication or misuse of any confidential information provided that such restrictions shall cease to apply to any confidential information which may enter the public domain other than through the default of the Executive but in any event the restrictions in this Clause 13.1 shall remain in full force and effect for so long as the Executive is in a position to utilise such information more readily than persons who have not been employed by the Company or its Associated Companies. 13.2 All notes and memoranda of any trade secret or confidential information concerning the business of the Company or the Associated Companies or any of its or their suppliers, agents, distributors, customers or others which shall have been acquired, received or made by the Executive during the course of his employment shall be the property of the Company and shall be surrendered by the Executive to someone duly 10 authorised in that behalf at the termination of his employment or at the request of the Board at any time during the course of his employment. 13.3 Without prejudice to the generality of Clause 13.1 the following is, for the avoidance of doubt, a non-exhaustive list of matters which in relation to the Company and the Associated Companies are considered confidential and must be treated as such by the Executive (for the purposes of this Agreement): (a) any trade secrets of the Company or any Associated Company; (b) any information in respect of which the Company or any Associated Company is bound by an obligation of confidence to any third party; (c) customer lists and details of contacts with or requirements of customers; and (d) any invention, technical data, know-how, instruction or operations manual or other manufacturing or trade secrets of the Group and their clients/customers. 13.4 The Executive shall comply with any reasonable policy produced by the Company concerning the Executive's ability to either directly or indirectly publish any opinion, fact or material or deliver any lecture or address or participate in the making of any film, radio broadcast or television transmission or communicate with any representative of the media or any third party relating to the business or affairs of the Company or any Associated Company or to any of its or their officers, employees, customers/clients, suppliers, distributors, agents or shareholders or to the development or exploitation of Works or IPRs (as defined in Clauses 12.1 and 12.2). For the purpose of this Clause "media" shall include television (terrestrial, satellite and cable) radio, newspapers and other journalistic publications. 14. Termination of Employment 14.1 The employment of the Executive may be terminated by the Board forthwith without notice or payment in lieu of notice if the Executive: (a) commits any serious or persistent breach or non-observance of any of the terms, conditions or stipulations contained in this Agreement having been, in the case of persistent breaches, warned in advance by the Board in writing of the same; (b) is guilty of any gross default or gross misconduct in connection with or affecting the business or affairs of the Company or any Associated Company for which he is required to perform duties; (c) is guilty of conduct which brings or is likely to bring himself or the Company or any Associated Company into disrepute; 11 (d) is convicted of an arrestable criminal offence (other than an offence under the road traffic legislation in the United Kingdom or elsewhere for which a non-custodial penalty is imposed); (e) is adjudged bankrupt or makes any arrangement or composition with his creditors or has an interim order made against him pursuant to section 252 of the Insolvency Act 1986; (f) becomes of unsound mind or becomes a patient under the Mental Health Act 1983; (g) is or becomes prohibited by law from being a director; or (h) voluntarily resigns as a director of the Company otherwise than at the request of the Board. 14.2 The employment of the Executive shall terminate automatically and without prior notice upon his attaining the age of 65. 14.3 Upon the termination of his employment (for whatever reason and howsoever arising) the Executive: (a) shall not take away, conceal or destroy but shall immediately deliver up to the Company all documents (which expression shall include but without limitation notes, memoranda, correspondence, drawings, sketches, plans, designs and any other material upon which data or information is recorded or stored) relating to the business or affairs of the Company or any Associated Company or any of their clients/customers, shareholders, employees, officers, suppliers, distributors and agents (and the Executive shall not be entitled to retain any copies or reproductions of any such documents) together with any other property belonging to the Company or any Associated Company (including his car and its keys) which may then be in his possession or under his control; (b) shall, at the request of the Board and without prejudice to any rights of the Executive arising as a result of the loss of his employment hereunder, immediately resign without claim for compensation from office as a director of the Company and any Associated Company and from any other office held by him in the Company or any Associated Company (but without prejudice to any claim he may have for damages for breach of this Agreement) and in the event of his failure to do so the Company is hereby irrevocably authorised to appoint some person in his name and on his behalf to sign and deliver such resignations to the Board and/or to each such Associated Company; (c) shall not at any time thereafter make any untrue or misleading oral or written statement concerning the business and affairs of the Company or any Associated Company nor represent himself or permit himself to be held out as being in any way connected with or interested in the business of the Company or any Associated Company (except as a former employee for the purpose of 12 communicating with prospective employers or complying with any applicable statutory requirements); (d) shall not at any time thereafter use the name "Shire" or any name capable of confusion therewith (whether by using such names as part of a corporate name or otherwise); and (e) shall immediately repay all outstanding debts or loans due to the Company or any Associated Company and the Company is hereby authorised to deduct from any wages (as defined by section 27 of the Employment Rights Act 1996) of the Executive a sum equal to any such debts or loans. 14.4 If the employment of the Executive under this Agreement is terminated by reason of the liquidation of the Company for the purpose of reconstruction or amalgamation or as part of any arrangement for the amalgamation or reconstruction of the Company not involving insolvency and the Executive is offered employment with any concern or undertaking resulting from the reconstruction or amalgamation on terms and conditions which taken as a whole are not less favourable than the terms of this Agreement then the Executive shall have no claim against the Company in respect of such termination. 15. Executive's Covenants 15.1 The Executive acknowledges that during the course of his employment with the Company he will receive and have access to confidential information of the Company and its Associated Companies (including without limitation those matters specified in Clause 13.3 of this Agreement) and he will also receive and have access to detailed client/customer lists and information relating to the operations and business requirements of those clients/customers and accordingly he is willing to enter into the covenants described in this Clause 15 in order to provide the Company and its Associated Companies with what he considers to be reasonable protection for those interests. 15.2 In this Clause 15: (a) "Restricted Business" means the Business of the Company and its Associated Companies at the time of the termination of the Executive's employment with which the Executive was involved to a material extent at any time during the period of 12 (twelve) months ending on the Restriction Date and for the purposes of this Clause 15 the term "Business" shall mean the research, development, marketing, sale or supply of pharmaceuticals for administration to humans; (b) "Restricted Customer" means any firm, company or other person who, at any time during the period of 12 (twelve) months ending on the Restriction Date, was a customer of or in the habit of dealing with the Company or any Associated Company and with whom the Executive dealt to a material extent or for whom or which the Executive was responsible on behalf of the 13 Company or any Associated Company during that period and in respect of such customer material damage to the interests of the Company or any Associated Company could occur if such customer ceased or reduced its business with the Company or any Associated Company; (c) "Restricted Employee" means any person who, at the Restriction Date was employed by the Company or any Associated Company at a senior level and who could materially damage the interests of the Company or any Associated Company if he became employed in any business concern in competition with any Restricted Business and with whom the Executive worked closely or about whom the Executive obtained material detailed information, in either case at any time during the period of 12 (twelve) months ending on the Restriction Date; and (d) "Restriction Date" means the date of termination of this Agreement. 15.3 The Executive will not, for a period of 12 (twelve) months after the Restriction Date, solicit or endeavour to entice away from the Company or any Associated Company the business or custom of a Restricted Customer with a view to providing or receiving goods or services to or from that Restricted Customer in competition with any Restricted Business. 15.4 The Executive will not, for a period of 12 (twelve) months after the Restriction Date, provide goods or services to or otherwise have any business dealings with any Restricted Customer in the course of any business concern which is in competition with any Restricted Business. 15.5 The Executive will not, for a period of 12 (twelve) months after the Restriction Date, in the course of any business concern which is in competition with any Restricted Business offer employment to or otherwise endeavour to entice away from the Company or any Associated Company any Restricted Employee. 15.6 The Executive will not, without the prior written consent of the Board, for a period of 6 (six) months after the Restriction Date, be engaged in or concerned in any capacity in any business concern which is or might reasonably be expected to be in competition with any Restricted Business. This Clause shall not restrain the Executive from being engaged or concerned in any business concern in so far as the Executive's duties or work shall relate solely: (a) to geographical areas where the business concern is not in competition with the Restricted Business; or (b) to services or activities of a kind with which the Executive was not concerned to a material extent during the period of 12 (twelve) months ending on the Restriction Date. 14 15.7 The obligations imposed on the Executive by this Clause 15 extend to him acting not only on his own account but also on behalf of any other firm, company or other person and shall apply whether he acts directly or indirectly. 15.8 The Executive hereby agrees that he will at the request and expense of the Company enter into a direct agreement or undertaking with any Associated Company whereby he will accept restrictions and provisions corresponding to the restrictions and provisions in this Clause 15 (or such of them as may be appropriate in the circumstances) in relation to such activities and such area and for such a period not exceeding 12 (twelve) months as such Associated Company may reasonably require for the protection of its legitimate business interests. 15.9 It is agreed between the parties that whilst the restrictions set out in this Clause 15 are considered fair and reasonable for the protection of the Company's business and trade secrets, if it should be found that any of the restrictions be void as going beyond what is fair and reasonable in all the circumstances and if by deleting part of the wording or substituting a shorter period of time or different geographical limit or a more restricted range of activities for any of the period of time, geographical limits or ranges or activities set out in this Clause 15 it would not be void then there shall be substituted such next less extensive period and/or limit and/or activity or such deletions shall be made as shall render this Clause 15 valid and enforceable. 16. Change of Control 16.1 For the purposes of this Clause 16: (a) "Relevant Event" means either: (i) the termination by the Company of the Executive's employment (other than for cause in accordance with Clause 14 of this Agreement); or (ii) the Executive's resignation where such resignation is as a consequence of a repudiatory breach of contract by the Company and amounts to a constructive dismissal, within the period of 12 (twelve) months following the date of a Change of Control. (b) Subject to Clause 16.6 below "Change of Control" means where any person either alone or together with any person acting in concert with him obtains control of the Company as defined in section 840 of the Income and Corporation Taxes Act 1988. 16.2 If a Relevant Event occurs the Company shall pay to the Executive within 14 (fourteen) days of that Relevant Event a sum equal to the aggregate of: (a) the value of his then current rate of basic salary for the period of 2 (two) years; and 15 (b) an additional amount equal to 2 (two) times the annual bonus to which the Executive would have been entitled pursuant to Clause 4 based on an assumed 100% on target achievement of group and personal objectives in the year of termination of his employment. 16.3 Subject to any rights accrued at the date of termination of the Executive's employment under the provisions of any pension scheme of the Company, any payment by the Company pursuant to this Clause 16 shall be made in full and final settlement of all and any claims arising from or in connection with the Executive's employment or its termination or his office as Group Research and Development Director or its loss in each case in respect of the Company or any Associated Companies. 16.4 All payments to be made pursuant to this Clause 16 shall be paid less any necessary withholdings. 16.5 The Executive hereby agrees that he shall not, following a payment under this Clause 16, bring any claim before any court or employment tribunal relating to unfair dismissal. 16.6 This Clause shall not apply where in connection with a scheme of reconstruction or amalgamation or reorganisation of the Company and one or more of its Associated Companies the Executive refuses an offer of employment on terms identical in all material respects to those hereunder by the company which following such reconstruction or reorganisation replaces the Company or the relevant Associated Companies. 17. Disciplinary and Grievance Procedures 17.1 The Executive shall be expected to maintain the highest standard of integrity and behaviour. For the purpose of disciplinary and grievance procedures the Executive's supervisor is the Company's Chief Executive. 17.2 If the Executive is not satisfied with any disciplinary decision taken in relation to him he may apply in writing within 14 (fourteen) days of that decision to the Board whose decision shall be final. 17.3 If the Executive has any grievance in relation to his employment he may raise it in writing with the Board whose decision shall be final. 17.4 If the Executive is not satisfied with any decision taken by the Chief Executive in relation to any grievance raised by him, he may apply in writing within 14 (fourteen) days of that decision, to the Board whose decision shall be final. 16 18. Directorship The Executive shall not save at the request or with the consent of the Board: (a) voluntarily resign as a director of the Company; (b) do or fail to do anything which causes him to be prohibited by law from continuing to act as a director; or (c) voluntarily do or refrain from doing any act whereby his office as a director of the Company is or becomes liable to be vacated. The removal of the Executive from office as a director of the Company or the failure of the Company in general meeting to re-elect the Executive as a director of the Company (if he shall be obliged to retire by rotation or otherwise pursuant to the Articles of Association) shall terminate the Executive's employment under this Agreement and such termination shall be without prejudice to any claim which the Executive may have for damages for breach of this Agreement provided that the Company was not entitled at the time of such removal or failure to re-elect to terminate his employment pursuant to Clause 14.1. 19. Data Protection The Executive consents to the Company or any Associated Company holding and processing both electronically and manually the data it collects which relates to the Executive for the purposes of the administration and management of its employees and its business and for compliance with applicable procedures, laws and regulations. The Executive also consents to the transfer of such personal information to other offices the Company may have or to an Associated Company or to other third parties whether or not outside the European Economic Area for administration purposes and other purposes in connection with the Executive's employment where it is necessary or desirable for the Company to do so. 20. Notices 20.1 Any notice to be given under this Agreement shall be given in writing and shall be deemed to be sufficiently served by one party on the other if it is delivered personally or is sent by first class registered or recorded delivery pre-paid post (air mail if overseas) addressed to either the Company's registered office for the time being or the Executive's address as set out in this Agreement (or such other address as shall be notified to the Company in accordance with this Clause) as the case may be. 20.2 Any notice sent by post shall be deemed (in the absence of evidence of earlier receipt) to be received 2 (two) days after posting (6 (six) if sent by air mail) and in proving the time such notice was sent and shall be sufficient to show that the envelope containing it was properly addressed, stamped and posted. Any notice delivered personally shall be deemed to be received when delivered to the address provided for in Clause 20.1. 17 21. Miscellaneous 21.1 The Executive hereby warrants that by virtue of entering into this Agreement he will not be in breach of any express or implied terms of any contract or of any other obligations legally binding upon him. 21.2 This Agreement supersedes the service agreement between the parties dated 30 December 1998 and the letter from the Company to the Executive dated 12 August 2002 which shall cease to have effect. 21.3 Any benefits provided by the Company to the Executive or his family which are not expressly referred to in this Agreement or the Letter of Offer shall be regarded as ex gratia benefits provided at the entire discretion of the Company and shall not form part of the Executive's contract of employment. 21.4 The Company shall be entitled at any time during the Executive's employment to make deductions from the Executive's salary or from any other sums due to the Executive from the Company or any Associated Company in respect of any overpayment of any kind made to the Executive or in respect of any debt or other sum due from him provided always that reasonable evidence of the validity of such deductions is provided to the Executive. 22. Definitions and Interpretation 22.1 In this Agreement: "Articles of Association" means the Company's articles of association in force at the date hereof and from time to time thereafter; "Associated Company" means a company which is from time to time a subsidiary or a holding company of the Company or a subsidiary (other than the Company) of a holding company of the Company. In this definition "subsidiary" and "holding company" have the same meaning as in section 736 of the Companies Act 1985; "Board" means the board of directors for the time being of the Company including any duly appointed committee thereof or the directors present at a meeting of the directors of the Company at which a quorum is present but excluding the Executive (as appropriate); "Group" means the Company and the Associated Companies; and 18 "Remuneration Committee" means the remuneration committee of the Board from time to time. 22.2 The headings in this Agreement are for convenience only and shall not affect its construction or interpretation. 22.3 References in this Agreement to Clauses are references to clauses in this Agreement. 22.4 Any reference in this Agreement to the employment of the Executive is a reference to his employment by the Company whether or not during the currency of this Agreement. 22.5 Any reference in this Agreement to a person shall where the context permits include a reference to a body corporate and to any unincorporated body of persons. 22.6 Any word in this Agreement which denotes the singular shall where the context permits include the plural and vice versa and any word in this Agreement which denotes the masculine gender shall where the context permits include the feminine and/or the neuter genders and vice versa. 22.7 Any reference in this Agreement to a statutory provision shall be deemed to include a reference to any statutory amendment, modification or re-enactment of it. 22.8 This Agreement is governed by and shall be construed in accordance with the laws of England and the parties to this Agreement hereby submit to the exclusive jurisdiction of the English courts. This Agreement supersedes all previous agreements of a similar nature between the parties or any Associated Company. IN WITNESS whereof this Agreement has been executed as a deed by the parties hereto and is intended and hereby delivered as a deed on the date first above written. Executed as a deed by ) SHIRE PHARMACEUTICALS ) GROUP PLC acting by a ) director and its secretary/ ) two directors ) 19 Executed as a deed by ) DR J W TOTTEN ) in the presence of: ) Signature of witness: ................................ Name: ................................ Address: ................................ ................................ ................................ Occupation: ................................ Dated [ ] November 2002 (1) SHIRE PHARMACEUTICALS GROUP PLC - and - (2) DR J W TOTTEN - - - - - - - - - - - - - - - - - - - - - - SERVICE AGREEMENT - - - - - - - - - - - - - - - - - - - - - - EX-21 6 shire10kex21.txt LIST OF SUBSIDIARIES EXHIBIT 21 LIST OF SUBSIDIARIES Principal subsidiary/undertaking Country of incorporation Roberts Pharmaceutical Corporation USA, State of New Jersey Shire Pharmaceutical Limited England and Wales Shire Pharmaceutical Development Limited England and Wales Shire International Licensing BV Netherlands Shire Laboratories Inc. USA, State of Delaware Shire Supplies U.S., LLC USA, State of Delaware Shire France S.A. France Shire Deutschland GmbH & Co. KG Germany Shire US Inc. USA, State of New Jersey Shire Pharmaceuticals Ireland Limited Ireland Shire Italia SpA Italy Shire Pharmaceutical Iberica S.L. Spain Shire Canada Inc. Canada Shire Pharmaceutical Development US Inc. USA, State of Maryland Shire BioChem Inc. Canada Shire Finance Limited Cayman Islands Shire Biologics Inc. USA, State of Massachusetts Shire Pharmaceutical Contracts Limited England and Wales Shire US Manufacturing Inc. USA, State of Maryland All of the Group's subsidiary undertakings are beneficially owned (directly or indirectly) as to 100% and are all consolidated in the results of the Group. EX-23.1 7 shire10kex231.txt DELOITTE & TOUCHE CONSENT EXHIBIT 23.1 INDEPENDENT AUDITORS' CONSENT We consent to the incorporation by reference in the Shire Pharmaceuticals Group plc Registration Statements on Form S-8 (Nos. 333-09168, 333-93543, 333-60952 and 333-91552), Form S-4 (333-55696) and Form S-3 (333-72862-01) of our report dated 26 February 2003 (which report expresses an unqualified opinion and includes an explanatory paragraph referring to the adoption of Statement of Financial Accounting Standard No. 142, Goodwill and Other Intangible Assets, on 1 January 2002), appearing in this Annual Report on Form 10-K of Shire Pharmaceutical Group plc for the year ended 31 December 2002. /s/ Deloitte & Touche - --------------------------- DELOITTE & TOUCHE Chartered Accountants Reading 28 March 2003 EX-23.2 8 shire10kex232.txt RAYMOND CHABOT GRANT THORNTON CONSENT EXHIBIT 23.2 INDEPENDENT AUDITORS' CONSENT We consent to the incorporation by reference in the Shire Pharmaceuticals Group plc ("Shire") Registration Statements on Form S-8 (Nos. 333-09168, 333-93543, 333-60952 and 333-91552), Form S-4 (333-55696) and Form S-3 (333-72862-01) of our report dated January 25, 2001, included in the annual report on Form 10-K of Shire filed March 31, 2003, on our audits of the consolidated financial statements of BioChem Pharma Inc., prepared in the United States of America dollars and in accordance with generally accepted accounting principles in United States of America, as at December 31, 2000 and 1999 and for the years ended December 31, 2000, 1999 and 1998 and to the use of our report with respect to the financial statements in the Shire annual report on Form 10-K filed March 31, 2003. /s/ Raymond Chabot Grant Thornton - ------------------------------------ Chartered Accountants General Partnership Montreal, Canada March 31, 2003 EX-99.1 9 shire10kex991.txt CERTIFICATION OF MATTHEW EMMENS EXHIBIT 99.1 Certification Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chapter 63, Title 18 U.S.C. ss.1350(a) and (b)) Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chapter 63, Title 18 U.S.C. ss.1350(a) and (b)), each of the undersigned hereby individually certifies in his capacity as an officer of Shire Pharmaceuticals Group plc (the "Company") that the Annual Report of the Company on Form 10-K for the year ended December 31, 2002 fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934 and that the information contained in such report fairly presents, in all material respects, the financial condition and results of operations of the Company. Dated: March 28, 2003 /s/ Matthew Emmens -------------------------------- Matthew Emmens Chief Executive The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chapter 63, Title 18 U.S.C. ss.1350(a) and (b)), is not a part of the Form 10-K to which it refers and is, to the extent permitted by law, provided by each of the above signatories to the extent of his respective knowledge. A signed original of this written statement required by Section 906 has been provided to Shire Pharmaceuticals Group plc and will be retained by Shire Pharmaceuticals Group plc and furnished to the Securities and Exchange Commission or its staff upon request. EX-99.2 10 shire10ex992.txt CERTIFICATION OF ANGUS RUSSELL EXHIBIT 99.2 Certification Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chapter 63, Title 18 U.S.C. ss.1350(a) and (b)) Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chapter 63, Title 18 U.S.C. ss.1350(a) and (b)), each of the undersigned hereby individually certifies in his capacity as an officer of Shire Pharmaceuticals Group plc (the "Company") that the Annual Report of the Company on Form 10-K for the year ended December 31, 2002 fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934 and that the information contained in such report fairly presents, in all material respects, the financial condition and results of operations of the Company. Dated: March 28, 2003 /s/ Angus Russell ------------------------- Angus Russell Group Finance Director The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chapter 63, Title 18 U.S.C. ss.1350(a) and (b)), is not a part of the Form 10-K to which it refers and is, to the extent permitted by law, provided by each of the above signatories to the extent of his respective knowledge. A signed original of this written statement required by Section 906 has been provided to Shire Pharmaceuticals Group plc and will be retained by Shire Pharmaceuticals Group plc and furnished to the Securities and Exchange Commission or its staff upon request. -----END PRIVACY-ENHANCED MESSAGE-----