Annual Report 2010 Annual Report 2010 15/03/2011 14:26 Page FC1
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8100 Annual Report 2010_Annual Report 2010 15/03/2011 14:26 Page FC1 Shire plc Annual ReportShire and Accounts 2010 Shire plc Annual Report and Accounts 2010 Delivering value Delivering value www.shire.com 8100 Annual Report 2010_Annual Report 2010 15/03/2011 14:26 Page IFC1 Shire plc Annual Repo Shire trademarks The following are trademarks either owned or licensed by Shire plc or companies within the Shire group (the ‘Group’) which are the subject of trademark registrations in certain territories, or which are owned by third-parties as indicated and referred to in this Annual Report: ADDERALL XR® (mixed salts of a single entity amphetamine) ADDERALL® (mixed salts of a single entity amphetamine) APRISO® (trademark of Salix Pharmaceuticals, Ltd. (‘Salix’)) ASACOL® (trademark of Medeva Pharma Suisse AG (used under license by Warner Chilcott Company, LLC (‘Warner Chilcott’))) ATRIPLA® (trademark of Bristol Myers Squibb Company (‘BMS’) and Gilead Sciences, Inc. (‘Gilead’)) BERINERT P® (trademark of Aventis Behring GmbH) CALCICHEW® range (calcium carbonate with or without vitamin D3) CARBATROL® (carbamazepine extended-release capsules) CEREZYME® (trademark of Genzyme Corporation (‘Genzyme’)) CINRYZE® (trademark of Viropharma Biologics, Inc.) CLAVERSAL® (trademark of Merckle Recordati) COLAZAL® (trademark of Salix Pharmaceuticals, Inc.) COMBIVIR® (trademark of GlaxoSmithKline (‘GSK’)) CONCERTA® (trademark of Alza Corporation (‘Alza’)) DAYTRANA® (trademark of Noven Pharmaceutical Inc. (‘Noven’)) DIPENTUM® (trademark of UCB Pharma Ltd (‘UCB’)) DYNEPO® (trademark of Sanofi-Aventis) ELAPRASE® (idursulfase) EPIVIR® (trademark of GSK) EPIVIR-HBV® (trademark of GSK) EPZICOM®/KIVEXA (EPZICOM) (trademark of GSK) EQUASYM® IR (methylphenidate hydrochloride) EQUASYM® XL (methylphenidate hydrochloride) FABRAZYME® (trademark of Genzyme) FIRAZYR® (icatibant) FOCALIN XR® (trademark of Novartis Pharmaceuticals Corporation (‘Novartis’)) FOSRENOL® (lanthanum carbonate) HEPTOVIR® (trademark of GSK) INTUNIV® (guanfacine extended release) JUVISTA® (trademark of Renovo Limited (‘Renovo’)) KALBITOR® (trademark of Dyax Corporation) KAPVAY® (trademark of Shionogi Pharma, Inc. (‘Shionogi’)) LIALDA® (mesalamine) MEDIKINET® (trademark of Medice Arzneimittel Pütter GmbH & Co. KG (‘Medice’)) METAZYM™ (arylsulfatase-A) METADATE CD® (trademark of UCB) MEZAVANT® (mesalazine) MOVICOL® (trademark of Edra AG, S.A.) PENTASA® (trademark of Ferring A/S Corp (‘Ferring’)) RAZADYNE® (trademark of Johnson & Johnson (‘J&J’)) RAZADYNE® ER (trademark of J&J) REMINYL® (galantamine hydrobromide) (United Kingdom (‘UK’) and Republic of Ireland) (trademark of J&J, excluding UK and Republic of Ireland) REMINYL XL™ (galantamine hydrobromide) (UK and Republic of Ireland) (trademark of J&J, excluding UK and Republic of Ireland) REPLAGAL® (agalsidase alfa) RESOLOR® (prucalopride) RITALIN LA® (trademark of Novartis) RUCONEST® (trademark of Pharming Intellectual Property B.V.) Content online ® SALOFALK (trademark of Dr Falk Pharma) Discover more about our business online at www.shire.com. ® SEASONIQUE (trademark of Barr Laboratories, Inc. (‘Barr’)) Scanning a QR code with your camera phone will directly ® SOLARAZE (trademark of Laboratorios Almirall S.A (‘Almirall’)) link you to mobile content. QR code reader applications STRATTERA® (trademark of Eli Lilly) are available from your App Store. TRIZIVIR® (trademark of GSK) TRUVADA® (trademark of Gilead) VENVANSE (lisdexamfetamine dimesylate) VPRIVTM (velaglucerase alfa) VYVANSE® (lisdexamfetamine dimesylate) XAGRID® (anagrelide hydrochloride) ZAVESCA® (trademark of Actelion Pharmaceuticals, Ltd.) ZEFFIX® (trademark of GSK) 3TC® (trademark of GSK) More online at www.shire.com ›› 8100 Annual Report 2010_Annual Report 2010 15/03/2011 14:26 Page 1 Shire plc Annual Report and Accounts 2010 1 Review of our business Contents Review of our business Already well on our way toward meeting 2 Chairman’s review 4 Chief Executive the ambitious goals we set for ourselves Officer’s review a few years back, we’re now looking even 8 Financial review further ahead at Shire and actively planning for a changing world. We’re intent on delivering innovative products and solutions to meet unmet medical needs and bring value to patients, physicians, payors, and policymakers, for the benefit of society Governance as a whole. We’re keeping patients at the Governance heart of all we do. 38 Board of Directors 40 Directors’ report 45 Corporate governance report 51 Nomination Committee Today, our portfolio is broader and more report 52 Audit, Compliance & balanced. Our international presence Risk Committee report 54 Directors’ remuneration continues to grow. We’re pioneering new report 68 Statement of Directors’ treatments and new delivery platforms responsibilities and seeking to offer patients new hope. Our results speak for themselves. Financial statements Financial statements 69 Independent auditors’ report 70 Consolidated balance sheets 71 Consolidated statements of income 72 Consolidated statements of changes in equity 74 Consolidated statements of comprehensive income 75 Consolidated statements of cash flows 77 Notes to the consolidated financial statements Other information Other information 122 Other information 126 Shire head offices and main operating locations 127 Shareholders information 129 Cautionary statements 130 Parent company financial statements of Shire plc 8100 Annual Report 2010_Annual Report 2010 15/03/2011 14:26 Page 2 2 Shire plc Annual Report and Accounts 2010 Shire plc Annual Repo Chairman’s review Continuing to provide best-in-class products that provide high value. Matthew Emmens, Chairman 2010 will not go down as the easiest year for the Shire has embarked on an aggressive pharmaceutical industry. The world is ageing, healthcare internationalization campaign—opening new offices costs are soaring, a recessionary global economy around the world, acquiring European companies such put enormous strains on public and personal budgets, as Movetis, and laying the foundation for the launch and payors turned increasingly to low-cost generics of products for diseases not well known or not well and to those branded products with proven societal treated. What is behind these developments? and medical value. What emerging trends has Shire The pharmaceutical industry is a global industry, and it is the been closely monitoring, and why? responsibility of companies like Shire to respond effectively Shire is paying careful attention to the rising pressure to physicians, patients, and payors all around the world. on global healthcare budgets, the higher standards set Shire is taking an approach to growth that is appropriate to by regulatory authorities, and the fact that pharmaceutical its size and mission—leveraging the international presence discovery itself grows increasingly more challenging—trends it has already gained through its work with patients with that are not new, but that certainly are accelerating. Shire rare orphan diseases such as Gaucher disease, Hunter is looking at how smaller companies like itself can continue syndrome and Fabry disease and scaling up as appropriate to take the right risks and to operate with the efficiencies that to serve patients with conditions ranging from attention the environment demands. Shire continues to recognize that deficit hyperactivity disorder (‘ADHD’) to ulcerative colitis. blockbuster products are growing harder and harder to come by and that ever increasing promotional spending cannot Shire has proven its ability to internationalize effectively— be the future. For Shire, the key to success continues to take advantage of internal capabilities and recently hired to be smaller niche markets and targeted therapeutics. new talent to make the most of its pipeline, know-how, and existing portfolio. Online at http://ar2010.shire.com ›› 8100 Annual Report 2010_Annual Report 2010 15/03/2011 14:26 Page 3 ort and Accounts 2010 Shire plc Annual Report and Accounts 2010 3 Review of our business 2010 highlights • Total revenues up 15% to $3.5 billion • Core product sales* up $700m (34%) • Total product sales exceeded $3 billion for the first time • Young and balanced portfolio and a strong pipeline *Product sales excluding ADDERALL XR. For the past several years, pharmaceutical companies What talents/resources/strategies does Shire have worked hard to define the word ‘value’—putting bring to this new era? Why are we confident in the increasing emphasis on health economics and health company’s future? technology assessments and broadening the range of Shire continues to be both intuitive in its ability to visualize products/solutions offered to patients and physicians. and adapt to a changing world and scientific in its ability In 2010, the emphasis on value grew even stronger. to discover and support the right opportunities. It is rare to Why? find a pharmaceutical company that is flexible, innovative, Value is ultimately defined by the markets—by ‘customers’. and opportunistic all at the same time—a company that It’s not about a price but rather about the relative value that can achieve 28% growth, in operating income, in an era a patient, a government, or an insurance company sees like this, a company whose people think like entrepreneurs, in a product or service. The tough environment that we find a company that continually evolves its business model. ourselves in demands value. This either means ‘low price’ Shire is fortunate to have the leadership of a strong, or ‘high value’ (meaning the product is worth the price).