2011 Annual Report â€" DTR 6.3.5 Disclosure

22nd Mar 2012 16:41

2011 Annual Report - DTR 6.3.5 Disclosure

March 22, 2012 - Shire plc , the global specialty biopharmaceutical company, announces that the following documents have today been posted or otherwise made available to shareholders:

* 2011 Annual Report

* Notice of the 2012 Annual General Meeting

* Form of Proxy

In accordance with Listing Rule 9.6.1, a copy of each of these documents has been uploaded to the National Storage Mechanism and will be available for viewing shortly.

The 2011 Annual Report and Accounts and Notice of the 2012 Annual General Meeting are also available on Shire's website at www.shire.com.

Disclosure & Transparency Rule (DTR) 6.3.5 requires the Company to disclose tothe media certain information from its Annual Report, if that information is ofa type that would be required to be disseminated in a half-yearly report.Accordingly, the Appendix to this announcement contains a management report andthe directors' responsibility statement. It should be read in conjunction withthe Company's unaudited full year results for the year ended December 31, 2011,issued on February 9, 2012 which comprises the Company's consolidated financialstatements prepared under U.S. GAAP. The Appendix together with the unauditedfull year results constitute the material required by DTR 6.3.5 to becommunicated to the media in unedited full text through a Regulated InformationService. This material is not a substitute for reading the full 2011 AnnualReport.

The information included in the Appendix is extracted from the 2011 Annual Report which was approved by the Directors on February 23, 2012.

Tony GuthrieDeputy Company Secretary

For further information please contact:

Investor Relations Eric Rojas [email protected] +1 781 482 0999 Sarah Elton-Farr [email protected] +44 1256 894157 Notes to editorsSHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on attention deficit hyperactivity disorder, human genetictherapies, gastrointestinal diseases and regenerative medicine as well asopportunities in other therapeutic areas to the extent they arise throughacquisitions. Shire's in-licensing, merger and acquisition efforts are focusedon products in specialist markets with strong intellectual property protectionand global rights. Shire believes that a carefully selected and balancedportfolio of products with strategically aligned and relatively small-scalesales forces will deliver strong results.

For further information on Shire, please visit the Company's website: www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, the Company's results could be materially adverselyaffected. The risks and uncertainties include, but are not limited to, risksassociated with: the inherent uncertainty of research, development, approval,reimbursement, manufacturing and commercialization of the Company's SpecialtyPharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, aswell as the ability to secure new products for commercialization and/ordevelopment; government regulation of the Company's products; the Company'sability to manufacture its products in sufficient quantities to meet demand;the impact of competitive therapies on the Company's products; the Company'sability to register, maintain and enforce patents and other intellectualproperty rights relating to its products; the Company's ability to obtain andmaintain government and other third-party reimbursement for its products; andother risks and uncertainties detailed from time to time in the Company'sfilings with the Securities and Exchange Commission.APPENDIXContents Page 1. Business review - Chairman's review 4 - Chief Executive Officer's review 5 - Overview 7 - Currently marketed products 7 - Manufacturing and distribution 10 - Intellectual property 11 - Competition 11 - Business strategy overview 14 - Products under development 15 - Business development 20 - Results of operations for the year to December 31, 212011 - Financial condition at December 31, 2011 27 - Liquidity and capital resources 27 - Treasury policies and organization 32 2. Principal risks and uncertainties - Mitigation of principal risks 36 - Risk factors related to Shire's business 37 - Risk factors related to the pharmaceutical and 40biotechnology industries in general 3. Directors' responsibility statement - Directors' responsibility statement 44 1. Business review Chairman's review

Those of us monitoring the global economy throughout 2011 saw many forces at play.

On the one hand, recessionary headwinds, aging populations, the growing prevalence of chronic disease, and the resultant cost of funding new medicines and technologies pressured already strained healthcare budgets and payors.

On the other, the healthcare expectations of people grew, and the extraordinaryinnovation of scientists and researchers brought new treatments to the market,continuing to change the way disease is both diagnosed and treated.

Against this backdrop, those who develop and market medicines had important decisions to make. What pipeline projects should be advanced? What products will be reimbursed? How should resources be distributed within a rapidly changing world? What could pharmaceutical companies do for patients whose wellbeing-and, indeed, sometimes their lives-often depend on effective treatment?

As Shire's Chairman, I was reassured by the many ways this specialtybiopharmaceutical company both recognized and addressed the global pressures.It reinforced its commitment to specialist physicians and specialty medicines,expanded key manufacturing capabilities, gained approvals for provenmedications in new countries, and maintained its focus on responsibility. Itmaintained its track record as a strategic organization that doesn't just reactto the challenges of the day, but also anticipates them.During the year Shire took risks-moved into new therapeutic areas, launchedinnovative development projects, diversified its team, and required more ofitself in essential ways. Shire's ability to rise above the noise of the yearand to make steady progress on behalf of patients, physicians, payors, andpolicymakers profoundly accelerated its position as a company willing to askhard questions, make significant changes, and lead by example.My association with Shire began in 2003. I continue to be grateful for thedepth of the leadership team and the dedication, innovation, and energy thatall Shire people bring to work each day. I am grateful as well for theconsiderable wisdom that Jeffrey Leiden and Patrick Langlois brought to ourBoard in their final year with Shire. I now look forward to working with SusanKilsby, an investment banker with global expertise who recently joined ourBoard and the other members of the Shire Board in the year ahead.No one is expecting the dynamics playing out across the global economy to easesoon. Certainly there will be more questions than answers. But Shire'sstrategy and delivery of meaningful solutions will continue to differentiatethe company as the future unfolds.

Matthew Emmens

Chairman

Chief Executive Officer's review

Throughout 2011 at Shire, we were thinking about value. About how to do morein challenging times. About understanding the complex and interwoven needs ofpatients, physicians, payors, and policymakers. We recognize that patients'lives improve only when we understand not just them, but the entire web ofcare. We believe that when we respond thoughtfully to the concerns of others,we perpetuate what we've come to call the circle of value. We're not justinterested in advancing our own standing in the healthcare community. We'recommitted to the basic ideal that when we can help create value for others webecome more valuable ourselves.Our long-term strategy of delivering differentiated specialty products,focusing on symptomatic diseases, and making responsible, disciplinedinvestments in research and development produced yet another strong year. Ourworldwide product sales were up 26% for the year, revenue grew to $4,263million, operating income was $1,109 million, and diluted earnings per ADS were$4.53. With some 5,000 people operating in 29 countries, and a balancedportfolio of products, we continued to leverage a strategy that year after yeardelivers results, even in turbulent economic times.Still, we want to do more. We're focused on all our stakeholders-patients,physicians, policymakers, payors, investors, and employees. In 2011, we spenttime in the company of patients, their families, their communities. We talkedto physicians about the frustrations they face as they seek to treat symptomsand make diagnoses. We talked to policymakers around the world and we talkedto payors about how they measure and reward value. We talked, we listened, andwe responded to the benefit of all of our stakeholders-systematically advancingour pipeline. We grew both organically and through acquisitions. We continued to explore thepotential application of lisdexamfetamine dimesylate, currently approved asVYVANSE in the US for children and adults with attention deficit hyperactivitydisorder ("ADHD"), in conditions ranging from negative symptoms and cognitiveimpairment in schizophrenia and major depressive disorder to binge eating andexcessive daytime sleepiness. These are all conditions for which there arenot, at this time, adequate treatments.We also made significant headway in our research on the potential applicationof mesalamine, our ulcerative colitis medicine sold as LIALDA/MEZAVANT in 16countries around the world, for those diagnosed with diverticulitis. Two Phase3 studies will be completed this year for this painful and life-alteringcondition, which often results in repeated flare-ups and is not adequatelymanaged by current medicines.At the same time, within our Human Genetic Therapies ("HGT") business, wecontinued our exploration of the potential application of intrathecaldelivery-the use of ports to deliver medicine directly to the central nervoussystem-for the treatment of Hunter syndrome, Sanfilippo, and MetachromaticLeukodystrophy. As this research program advances, we hope to be able to domore for patients diagnosed with these often life-threatening and heartbreakingdiseases. We made great headway as well for patients depending on our HGT enzymereplacement therapy products. The accelerated construction and approval of anew manufacturing facility, in Lexington, Massachusetts, ensured greater accessand a sustainable supply of medication for patients diagnosed with Fabry andGaucher disease. Meanwhile, we beat our own deadlines as we worked to expandthe manufacturing capacity of VPRIV, now available in 30 countries acrossEurope and serving patients with type 1 Gaucher disease. We also launchedFIRAZYR, an orphan drug used for the treatment of acute attacks of hereditaryangioedema ("HAE") in adults 18 years of age or older in the US. Throughoutthe year, we continued to meet with patients and physicians- in conferences andat special meetings-all with an eye toward working together to ensure betterdiagnoses and more effective treatments.Our ambition to reach beyond our current expertise also resulted in theacquisition of Advanced BioHealing, Inc. ("ABH"), which brought us a newbusiness in Regenerative Medicine-adding to our portfolio DERMAGRAFT, abioengineered skin substitute that assists in restoring damaged tissue andsupports the body's natural healing process. Created from cultured skin cellsand applied via a biodegradable mesh, DERMAGRAFT is approved in the US for thetreatment of diabetic foot ulcers. The continued growth of ABH within Shirehas, we believe, demonstrated the potential that can be made from a focusedregenerative medicine business. We are excited about the opportunities in thisarea and are looking forward to bringing DERMAGRAFT to more patients and toexpanding Shire's offering in regenerative medicine.

We strengthened our global presence throughout the year-expanding our international hub in Nyon, Switzerland, with diverse and talented people; opening offices and finalizing marketing agreements in countries ranging from Brazil to Japan and keeping an eager eye on new opportunities where we can serve our multiple stakeholders effectively.

Throughout the year, we made continuing investments in our culture-reinforcing,through numerous channels, just what it is to be a Shire employee. Throughvarious programs we reinforced our commitment to differentiating ourselves asthe company that always strives to be as brave as the people we help. Weworked to ensure that our employees are inspired by our strategic vision, thatthey understand the importance of fostering our brave values, and that they areimproving their ability to both listen and respond-all of which contributes toour collaborative, responsible environment. We launched the first of what will become an annual external recognitionprogram-the BRAVE Awards, in which non-professional caregivers from around theworld were recognized and rewarded for their courage and dedication, and forthe difference they make in the lives of those they care for.Though by many measures 2011 will be remembered as another year of greatsuccess for Shire, we also think of it as a year in which we developed newgrowth opportunities. In 2012, we'll continue to invest in our people,pipeline, and values-in those things that differentiate us as a company. We'llprepare for the launch of VENVANSE in Europe, advance pipeline projects, andlook for new acquisitions-defining and assessing the value of such programs asearly as possible. But most of all, we will be listening-paying acute attention to the worldaround us and continuing to address the needs of the stakeholders who make upour circle of value. I look forward to sharing our news with you as the yearprogresses. Finally, I would like to acknowledge those who make Shire's story so distinct,so vibrant, and so full of promise: our people. Many have been helping todrive our growth for some years now. Others, such as the 400 or so individualsfrom ABH and the talent newly hired into positions all around the world, arejust starting to contribute their insights, creativity, and expertise toShire. Speaking for the entire leadership team, we are grateful for therelentless efforts and dedication, the ambitions, and the proven capabilitiesof all Shire employees.Angus RussellChief Executive OfficerOverview

Shire plc (the `Company') and its subsidiaries (collectively `Shire' or the`Group') has the strategic goal to be the world's leading specialtybiopharmaceutical company that focuses on meeting the needs of the specialistphysician. Shire focuses its business on ADHD, gastrointestinal (`GI')diseases, HGT and Regenerative Medicine ("RM"), as well as opportunities inother therapeutic areas to the extent they arise through acquisitions. Shire'sin-licensing and acquisition efforts are focused on products in specialistmarkets with strong intellectual property protection or other forms of marketexclusivity and global rights. Shire believes that a carefully selected andbalanced portfolio of products with strategically aligned and relativelysmall-scale sales forces will deliver strong results. Substantially all of the Company's revenues, expenditures and net assets areattributable to the R&D, manufacture, sale and distribution of pharmaceuticalproducts within three reportable segments: Speciality Pharmaceuticals ("SP"),HGT and RM. The Company also earns royalties (where Shire has out-licensedproducts to third parties) which are recorded as revenues.

Revenues are derived primarily from two sources - sales of the Company's own products and royalties:

* 93% (2010: 90%) of total revenues are derived from product sales, of which

66% (2010: 71%) are within SP, 31% (2010: 29%) are within HGT and 3% (2010:

nil) are within RM; and

* 6% of total revenues are derived from royalties (2010: 9%).

Currently marketed products

The table below lists the Group's material marketed products at December 31, 2011 indicating the owner/licensor, disease area and the key territories in which Shire markets the product.

SPECIALTY PHARMACEUTICALS ("SP")

Product Disease area Owner/licensor Key territories Treatments for ADHD VYVANSE/VENVANSE ADHD Shire US, Canada and (lisdexamfetamine Brazil (1) dimesylate) Adderall XR (mixed ADHD Shire US and Canada salts of a single entity amphetamine) INTUNIV (extended ADHD Shire US release guanfacine) EQUASYM ADHD Shire Europe and Latin(methylphenidate America(2) hydrochloride) modified release (XL)

Treatments for Gastrointestinal ("GI") diseases

LIALDA (mesalamine)/ Ulcerative colitis Giuliani SpA US and Europe(3)MEZAVANT(mesalazine) Pentasa (mesalamine) Ulcerative colitis Shire US

Resolor (prucalopride) Chronic constipation Shire Europe

in women

Treatments for diseases in other therapeutic areas

Fosrenol (lanthanum Hyperphosphatemia in Shire US, Europe and carbonate) end stage renal Japan(2, 4) disease XAGRID (anagrelide Elevated platelet Shire Europe(2) hydrochloride) counts in at risk essential thrombocythemia patients

HUMAN GENETIC THERAPIES ("HGT")

Product Disease area Owner/licensor Key territories REPLAGAL (agalsidase Fabry disease Shire Europe, Latin alfa) America and Asia Pacific(5)

ELAPRASE (idursulfase) Hunter syndrome Shire US, Europe,

(Mucopolysaccharidosis Latin America Type II, MPS II) and Asia Pacific (6) VPRIV (velaglucerase Gaucher disease, type Shire US, Europe and alfa) 1 Latin America FIRAZYR (icatibant) HAE Shire US, Europe and Latin America REGENERATIVE MEDICINE ("RM") Product Disease area Owner/licensor Key territories DERMAGRAFT(Human Diabetic Foot Ulcers Shire US Fibroblast-Derived ("DFU") Dermal Substitute)

(1) The product is marketed as VENVANSE in Brazil.

(2) Marketed by distributors in certain markets.

(3) Marketed in US as LIALDA and in Europe as MEZAVANT XL or MEZAVANT.

(4) Marketed in Japan under license from Shire by Bayer Yakuhin Limited ("Bayer").

(5) Marketed in Japan under license by Dainippon Sumitomo Pharma Co., Ltd. ("DSP").

(6) Marketed in Asia Pacific by Genzyme under license from Shire.

Royalties received from other products

Anti viral productsProduct Principal Relevant territory/marketed by indications 3TC/EPIVIR (lamivudine) HIV Canada / Shire & ViiV (1); RoW / ViiV COMBIVIR (lamivudine and HIV Canada / Shire & ViiV; RoW / zidovudine) ViiV TRIZIVIR (lamivudine, HIV Canada / Shire & ViiV; RoW / zidovudine and abacavir) ViiV

EPZICOM/KIVEXA (lamivudine HIV Canada / Shire & ViiV; RoW

/ and abacavir) ViiV

ZEFFIX/EPIVIR-HBV/ HEPTOVIR Hepatitis B Canada / Shire & GSK; RoW / GSK (2) (lamivudine)

infection (1) In 1996 Shire formed a commercialization partnership with GSK to market 3TCand ZEFFIX in Canada. In 2009 GSK assigned its interest in the partnership toViiV.

(2) This is not a comprehensive list of trademarks for this product. The product is also marketed under other trademarks in some markets.

Other products

ADDERALL XR

Shire receives royalties from Impax's sales of authorized generic ADDERALL XR.

FOSRENOL

The Company licensed the rights to FOSRENOL in Japan to Bayer in December 2003.Bayer launched FOSRENOL in Japan in March 2009. Shire receives royalties fromBayer's sales of FOSRENOL in Japan. The Company may also receive milestonepayments from Bayer based on the achievement of certain sales thresholds.

Other royalties

The Company has licensed the rights to other products to third parties and receives royalties on third party sales.

Manufacturing and distribution

Active pharmaceutical ingredient ("API") sourcing

The Company sources API from third party suppliers for its SP products and itsHGT product FIRAZYR. Shire has manufacturing capability for agalsidase alfa,idursulfase and velaglucerase alfa at its protein manufacturing plant inCambridge, Massachusetts, US for its HGT products, REPLAGAL, ELAPRASE and VPRIVand manufacturing capability for its RM product DERMAGRAFT at its manufacturingfacility in La Jolla, California, US.The Company currently has dual sources of API for VYVANSE, ADDERALL XR, LIALDAand PENTASA and is developing a second source for INTUNIV. The Company managesthe risks associated with reliance on single sources of API by carryingadditional inventories or developing second sources of supply.In order to support the rapid growth of VPRIV and REPLAGAL, as well as tosupport clinical development, additional manufacturing capacity has been addedin Lexington, Massachusetts, US. The facility has been approved for thepurification of REPLAGAL API, and in November 2011 the Company submittedregulatory filings with both the EMA and the FDA for the production of VPRIVAPI at the new facility. On February 21, 2012 the EMA's Committee for MedicinalProducts for Human Use approved the production of VPRIV in this facility.

DERMAGRAFT is grown from a cryopreserved master cell bank that was procured from a single neonatal foreskin sourced in 1990. The cell line has been qualified by the FDA and the Company performs extensive testing to help ensure the safety of the fibroblast cells in the master cell bank.

Finished product manufacturing

The Company sources all of its SP products from third party contract manufacturers. HGT finished products are manufactured by contract manufacturers specializing in aseptic fill-finish operations.

The Company currently has dual sources for ELAPRASE, REPLAGAL and VYVANSE andis developing a second source for the finished product manufacturing of LIALDA.The Company sources finished product for ADDERALL XR, FIRAZYR, FOSRENOL,INTUNIV, PENTASA, RESOLOR and VPRIV from a single contract manufacturer foreach product. The Company manages the risks associated with reliance on singlesources of production by carrying additional inventories.The Company currently utilizes numerous third party suppliers for the rawmaterials used in the manufacturing of DERMAGRAFT. The Company currentlyobtains certain serum reagents, the mesh framework and the manifold used in themanufacture of DERMAGRAFT from single suppliers. The Company manages the risksassociated with reliance on single sources by carrying additional inventoriesand, where appropriate, entering into contractual supply agreements with a bulkorder provision in the case of early termination by the supplier.During 2009, following a comprehensive evaluation of its operations andstrategic focus, Shire decided to phase out operations at its SP manufacturingfacility at Owings Mills, Maryland. This phase out was successfully completedduring 2011.DistributionThe Company's US distribution center for SP products, which includes a largevault to house US Drug Enforcement Administration ("DEA") regulated Schedule IIproducts, is located in Kentucky. From there, the Company primarily distributesits products through the three major wholesalers who have hub or distributioncenters that stock Schedule II drugs in the US, providing access to nearly allpharmacies in the US.

The distribution and warehousing of HGT products for the US market is contracted out to specialist third party contractors.

The Company ships DERMAGRAFT from its La Jolla, California facility using thirdparty carriers that are experienced in cold-chain logistics as well as from athird party carrier and distributor's site located in Louisville, Kentucky,from which the Company ships the majority of DERMAGRAFT intended for customerslocated in the Eastern part of the US.

Outside of the US, physical distribution of SP and HGT products is either contracted out to third parties (where the Company has local operations) or facilitated via distribution agreements (where the Company does not have local operations).

Material customersThe Company's three largest trade customers are Cardinal Health, Inc., McKessonCorp, and AmerisourceBergen which are based in the US. In 2011, these wholesalecustomers accounted for approximately 23%, 19% and 7% of product sales,respectively.

Intellectual Property

An important part of the Company's business strategy is to protect its productsand technologies through the use of patents and trademarks, to the extentavailable. The Company also relies on trade secrets, unpatented know-how,technological innovations and contractual arrangements with third parties tomaintain and enhance its competitive position where it is unable to obtainpatent protection or where marketed products are not covered by specificpatents. The Company's commercial success will depend, in part, upon itsability to obtain and enforce strong patents, to maintain trade secretprotection, to operate without infringing the proprietary rights of others andto comply with the terms of licenses granted to it. The Company's policy is toseek patent protection for proprietary technology whenever possible in the US,Canada, major European countries and Japan. Where practicable, the Companyseeks patent protection in other countries on a selective basis. In all casesthe Company endeavors to either obtain patent protection itself or supportpatent applications by its licensors. The markets for some of the potentialproducts for rare genetic diseases caused by protein deficiencies are small,and, where possible, the Company has sought orphan drug designation forproducts directed to these markets.

In the regular course of business, the Company's patents may be challenged by third parties. The Company is a party to litigation or other proceedings relating to intellectual property rights.

The degree of patent protection afforded to pharmaceutical inventions aroundthe world is uncertain. If patents are granted to other parties that containclaims having a scope that is interpreted by the relevant authorities to coverany of the Company's products or technologies, there can be no guarantee thatthe Company will be able to obtain licenses to such patents or make otherarrangements at reasonable cost, if at all.The existence, scope and duration of patent protection varies among theCompany's products and among the different countries where the Company'sproducts may be sold. They may also change over the course of time as patentsare granted or expire, or become extended, modified or revoked. The followingnon-exhaustive list sets forth details of granted US and EP patents pertainingto the Company's material products and certain products from which the Companyreceives a royalty, which are owned by, or licensed to, the Company and thatare important to an understanding of the Company's business taken as a whole.The listed EP patents do not necessarily have a corresponding national patentregistered in each EU member state and the rights granted pursuant to an EPpatent are enforceable only in the EU member state where the EP patent has beenregistered as a national patent. The expiration dates set forth below do notnecessarily reflect changes to the patent term afforded by Patent TermExtensions in the US, nor supplementary protection certificates ("SPCs") whichare available in many EU member states. The Company also holds patents in otherjurisdictions, such as Canada and Japan and has patent applications pending insuch jurisdictions, as well as in the US and the EU.

Competition

Shire believes that competition in its markets is based on, among other things,product safety, efficacy, convenience of dosing, reliability, availability andprice. Companies with more resources and larger R&D expenditures than Shirehave a greater ability to fund the research and clinical trials necessary forregulatory applications, and consequently may have a better chance of obtainingapproval of drugs that would then compete with Shire's products. Other productsnow in use or being developed by others may be more effective or have fewerside effects than the Company's current or future products. The market sharedata provided below is sourced from IMS Health.

ADHD market

Competition in the US ADHD market has increased with the launch of competingproducts in recent years, including the launch of an authorized generic versionof CONCERTA and RITALIN LA in 2011, and the launch of authorized genericADDERALL XR by Teva and Impax in 2009. In late 2010, KAPVAY (twice daily,clonidine extended release) was approved by the FDA for the treatment of ADHDand was launched in the US by Shionogi & Co., Ltd in 2011. Shire's share of theUS ADHD market in December 2011 was 27.9% (compared to 24.5% in December 2010).Overall the US ADHD market grew by 10.4% in the year to December 31, 2011(compared to 12.4% in the same period in 2010).Shire's key ADHD market is the US, with the Company having three products forthe treatment of ADHD (VYVANSE, ADDERALL XR and INTUNIV). Shire also has ADHDproducts in Canada, Brazil, Mexico, South Korea and selected EU markets andfurther geographic expansion plans are underway, including a collaboration withShionogi and Co. Ltd. to develop and sell ADHD products in Japan.Key branded competitors in the US are stimulants CONCERTA and FOCALIN XR, andnon-stimulants STRATTERA and KAPVAY. Generic immediate release stimulants whichconstitute 28.6% of the ADHD market (IMS NPA, December 2011) are alsoformidable in the US ADHD market, growing 2.4% in the year from December 31,2010 to December 31, 2011.

Key competitors in the European ADHD market are CONCERTA (Janssen-Cilag), RITALIN LA (Novartis), MEDIKINET (Medice and distributors) and STRATTERA (Eli Lilly), depending upon the country.

The Canadian market continues to show strong growth, driven particularly by the adult market. CONCERTA is the number one selling brand in volume and share, although for the moving annual total ("MAT") ending November 2011, generic methylphenidate volume and share grew by 15% and 2% respectively. Both the Brazilian and Mexican markets are growing strongly and in Brazil, which is predominantly an IR market, there is increasing penetration of the extended release brands.

The Company is also aware of several clinical development programs underway byother pharmaceutical companies. Eli Lilly and Company Limited, Targacept,Otsuka Pharmaceutical Co., Ltd., NextWave Pharmaceuticals, Inc., Purdue,Alcobra (in collaboration with Teva), Theravance, Euthymics, Neuroderm, DurectPharma and Supernus are seeking to develop additional treatment options forADHD.

GI

Ulcerative Colitis ("UC") market

UC is a type of inflammatory bowel disease. The first-line treatments for patients with mild to moderate UC are formulations containing mesalamine (also known as 5-ASA). Shire defines the 5-ASA competitive set as the non-sulfasalazine, oral mesalamine and mesalamine pro-drug products.

The US oral 5-ASA market is led by Warner Chilcott's ASACOL. In December 2011, ASACOL had a 37.4% share of the oral 5-ASA market, declining from 42.2% in December 2010.

In December 2011, Shire's share of the US UC market was 35.8% (compared to 34.5% in December 2010).

The EU oral 5-ASA market was somewhat more fragmented (all data in thisparagraph is stated as at November 2011). Ferring's PENTASA and WarnerChilcott's ASACOL were the major competitors across the EU. PENTASA (marketedin the EU by Ferring) captured 29.6% versus ASACOL's 19.0% share of the EU G5oral 5-ASA market (UK, Germany, Spain, Italy, and France). Warner Chilcott'sASACOL led the UK market with a 45.8% share, followed by Ferring's PENTASA,which had a 27.1% share. The German market was led by Dr Falk's SALOFALK, with53.2% market share, followed by Ferring's PENTASA with 18% share. Ferring'sPENTASA and CLAVERSAL were the leaders in the oral 5-ASA market in Spain with35.2% and 29.3% shares respectively. In 2010, Ferring launched a newcompetitor, PENTASA 1g tablet, in the EU and it has been launched in multiplecountries in 2010 and 2011.Mesalamine and balsalazide (mesalamine pro-drug) products are generallyprotected by formulation patents only. In December 2007, the FDA denied Salix'sCitizen Petition for COLAZAL and Salix subsequently announced the launch of anauthorized generic version by Watson Laboratories. Three other generic versionsof COLAZAL were then introduced. Generic versions of COLAZAL had a 7.5% shareof the US oral 5-ASA market in December 2011.

In May 2011, Cosmo / Ferring submitted an MAA in the EU for the oral corticosteroid, budesonide MMX, for the induction of remission in mild to moderate UC. In December 2011, Cosmo / Santarus submitted an NDA in the US for budesonide MMX for the same indication. If approved, this will be a new competitor in 2012 or 2013.

Janssen / MSD's biologic, REMICADE, is approved for treatment and maintenanceof moderate to severe UC in the US, Canada and the EU. Abbott submitted asupplemental NDA ("sNDA") in the US in late 2010 and the EMA in early 2011 foran indication in moderate to severe UC for HUMIRA.

The Company is aware of other 5-ASA and non-ASA biologic treatments in development for UC by Tillotts, Salix, Janssen, Cosmo, Pfizer, and Millenium.

Chronic constipation market

In Europe, over-the-counter and prescription laxatives are the current firstline therapy for chronic constipation. The highest value laxative (by revenue)is MOVICOL, a polyethylene glycol ("PEG") 3350, sold by Norgine. In Europe,RESOLOR is indicated for symptomatic treatment of chronic constipation in womenin whom laxatives fail to provide adequate relief and currently there are noother products available in the EU with the same indication.Almirall submitted an MAA in the EU in September 2011 for a guanylate cyclasetype-C agonist, linaclotide (under license from Ironwood), for the treatment ofirritable bowel symptoms with constipation ("IBS-C"), which if approved wouldbe a new competitor in the EU in 2012 or 2013. Ironwood submitted an NDA inOctober 2011 for linaclotide in the US for the treatment of IBS-C and chronicconstipation. If approved, we expect Ironwood and Forest (who are co-developingand co-promoting linaclotide in the US) to launch linaclotide in 2012 or 2013in the US.

In August 2011, Sucampo submitted an MAA in the UK for the chloride channel activator, lubiprostone, for chronic idiopathic constipation which, if approved, would be a new competitor in the UK in 2012.

The Company is aware of other therapies for the treatment of chronic constipation / IBS-C being developed by Synergy Pharmaceuticals, Inc., ARYx Therapeutics, Theravance, Inc., Sucampo Pharmaceuticals, Inc., and Albireo.

Markets for the treatment of rare genetic diseases

Competitors for LSDs include Actelion Ltd., Protalix BioTherapeutics Inc("Protalix"), and Genzyme. For example, REPLAGAL competes with Genzyme'sFABRAZYME, and VPRIV competes with Genzyme's CEREZYME, Actelion's ZAVESCA andwill compete with the Protalix compound taliglucerase alfa (worldwide rightsoutside of Israel licensed to Pfizer) if approved. Shire is aware of twocompanies (Korea Green Cross Corporation and JCR Pharmaceuticals Co. Ltd) thatare developing Enzyme Replacement Therapies("ERTs") for the treatment of Huntersyndrome. JCR and Isu-Abxis also have early stage biosimilar programs forGaucher and Fabry disease, and Harvest Moon and Dong A Pharmaceuticals haveearly stage biosimilar programs for Gaucher disease.FIRAZYR competes in Europe with CSL Behring's BERINERT P, a humanplasma-derived C1-esterase inhibitor (C1-INH) product, and with Pharming GroupN.V.'s RUCONEST (a recombinant version of C1-INH), which has been launched incertain European countries by Swedish Orphan Biovitrum. FIRAZYR also competesin Europe with ViroPharma's Cinryze, another human plasma-derived C1-esteraseinhibitor (C1-INH) product, which was approved in 2011 for both acute treatmentand prevention of acute HAE attacks. FIRAZYR competes in the US with BERINERTand with Dyax Corporation's KALBITOR, a plasma kallikrein inhibitor.ViroPharma's CINRYZE, is approved in the US only for prophylaxis of HAEattacks.

Regenerative Medicine

The medical device and biotechnology industries are characterized by rapidlyadvancing technologies, intense competition and a strong emphasis onproprietary products. Competition in the regenerative medicine industry isparticularly intense, due largely to the fact that regenerative medicineproducts currently compete with both traditional and advanced products, as wellas bio-engineered products. DERMAGRAFT competes with other products based onefficacy, price, reimbursement, ease of use and healthcare provider education.DERMAGRAFT competes in the US against other living cell products, such asOrganogenesis's APLIGRAF and also against manufacturers of traditional woundcare products, including Healthpoint's REGRANEX, Healthpoint's OASIS Matrixproducts, and Soluble System's THERASKIN. In addition, DERMAGRAFT competesagainst advanced mechanical technologies, such as negative pressure woundtherapy. Negative pressure wound therapy uses a vacuum to remove excess fluidand cellular waste that create inflammation and hinder ulcer healing. Currentcompetitors include KCI's V.A.C. therapy and Smith & Nephew's RENASYS.

HIV market

The HIV competitive landscape is becoming more crowded and complicated astreatment trends evolve. The Company's 3TC/lamivudine/EPIVIR products (alllicensed to GSK) are part of the Nucleoside/Nucleotide Reverse TranscriptaseInhibitors ("NRTI") market. TRIZIVIR, COMBIVIR and EPZICOM/KIVEXA are part ofthe combined NRTI market. TRUVADA (tenofovir/emtricitabine), sold by Gilead, isthe market leader in combination NRTI. In addition to the two NRTI HIV marketsin which lamivudine is sold, there is competition from NRTIs, PIs and entryinhibitors.TRUVADA and ATRIPLA (efavirenz/emtricitabine/tenofovir), cross-class fixed dosecombination also sold by Gilead, both represent the most direct competition tolamivudine.

Several generic drug companies have filed abbreviated new drug applications ("ANDAs"), seeking approval for EPIVIR, COMBIVIR, and EPZICOM in the US and several tentative approvals of generic lamivudine have been issued by the FDA. In December 2011, the FDA approved generic versions of EPIVIR that are manufactured by Aurobindo and Apotex.

Business strategy overview

The market in which the Company conducts its business is highly competitive and highly regulated.

There is increasing legislation both in the US and the Rest of the World("RoW") which is placing downward pressure on the net pricing of pharmaceuticalproducts and medical devices. For example the US government passed healthcarereform legislation in 2010 which included an increase in Medicaid rebate ratesand extended Medicaid rebates to those products provided through Medicaidmanaged care organizations. The legislation also imposed annual fees to be paidby both pharmaceutical manufacturers (from 2011) and medical device companies(from 2013). The impact of these recent changes to US healthcare legislation,and other healthcare reforms in the RoW, has not to date had a material impacton the Company's results of operations.

The healthcare industry is also experiencing:

* pressure from governments and healthcare providers to keep prices low while

increasing access to drugs; * increasing challenges from third party payors for products to have demonstrable clinical benefit, with pricing and reimbursement approval becoming increasingly linked to a product's clinical effectiveness and impact on overall costs of patient care;

* increased R&D costs, because development programs are typically larger and

take longer to get approval from regulators; * challenges to existing patents from generic manufacturers; * governments and healthcare systems favoring earlier entry of low cost generic drugs; and * higher marketing costs, due to increased competition for market share.

Shire's strategy to become the world's leading specialty biopharmaceutical company has been developed to address these industry-wide competitive pressures. This strategy has resulted in a series of initiatives in the following areas:

Markets

Historically, Shire's portfolio of approved products has been heavily weightedtowards the North American market. The acquisition in 2005 of TranskaryoticTherapies, Inc. ("TKT") and the consequent establishment of our HGT business,together with the acquisitions of Jerini in 2008 (which brought the HAE productFIRAZYR), EQUASYM in 2009 (which facilitated Shire's immediate access to theEuropean ADHD market) and Movetis in 2010 (which brought EU rights to RESOLORand further developed our GI pipeline), provided Shire with platforms toincrease its presence in Europe and the RoW, thereby working towardsdiversifying the risk associated with reliance on one geographic market.In 2011 the SP and HGT businesses derived 15% and 80%, respectively, of theirproduct sales from outside of the US. Currently all RM product sales aregenerated in the US. Shire's long-term mission is to increase the value ofproduct sales from (i) outside of the US and (ii) outside of US, UK, Germany,France, Italy, Spain and Canada. Shire has made significant progress towardsgeographic diversification with additional development and commercializationactivities in 2011. In addition, Shire has ongoing commercialization andlate-stage development activities which are expected to further supplement thediversification of revenues in the future, including the following: * continued launch of VYVANSE in Brazil (marketed as VENVANSE) and the potential approval and launch of VYVANSE in Mexico; * filing in 2011 of an MAA for VYVANSE (to be marketed as VENVANSE) in

certain countries in the EU to support registration for treatment of ADHD

in children;

* INTUNIV Phase 3 clinical program to support submission of an MAA in the EU;

* continued roll-out of VPRIV in certain EU and Latin American countries; * continued roll-out of FIRAZYR in certain European and Latin American countries; * the LIALDA/MEZAVANT diverticulitis Phase 3 program; and * continued roll-out of RESOLOR in the EU and the RoW.

R&D

Over the last five years Shire has focused its R&D efforts on products in itscore therapeutic areas and concentrated its resources on obtaining regulatoryapproval for later-stage pipeline products within these core therapeutic areas.In addition to continued efforts in its late stage pipeline for the ADHD, GI,HGT and RM therapeutic areas, Shire has also progressed work on an earlierstage pipeline.Evidence of the successful progression of the late stage pipeline can be seenin the granting of approval and associated launches of the Company's productsover the last seven years. Since January 2005, several products have receivedregulatory approval including: in the US, ELAPRASE in 2006, LIALDA and VYVANSEin 2007, INTUNIV in 2009, VPRIV in 2010, and FIRAZYR in 2011; in the EU,FOSRENOL in 2005, ELAPRASE and MEZAVANT in 2007, and VPRIV in 2010; in Canada,VYVANSE in 2010.Shire's strategy is focused on the development of product candidates that havea lower risk profile. As Shire further expanded its earlier phase pipeline, R&Dcosts in 2011 included expenditure on several pre-clinical to Phase 3 studiesfor products in development as well as Phase 3(b) and Phase 4 studies tosupport recently launched products in the SP and HGT businesses, together withthe development of new projects in both the SP, HGT and RM businesses.

Patents and market exclusivity

The loss or expiration of patent protection or regulatory exclusivity withrespect to any of the Company's major products could have a material adverseeffect on the Company's revenues, financial condition and results ofoperations, as generic manufacturers may enter the market. Genericmanufacturers often do not need to complete extensive clinical studies whenthey seek registration of a copy product and accordingly, they are generallyable to sell the Company's drugs at a much lower price.As expected, in 2009 Teva and Impax commenced commercial shipments of theirauthorized generic versions of ADDERALL XR, which led to lower sales of brandedADDERALL XR compared to the period prior to the authorized generic launch. TheFDA has not yet reached a decision on the Citizen Petition for ADDERALL XRwhich was filed in October 2005. An FDA decision which does not require genericfollow-on products to complete successful bio-equivalence or additionalclinical testing could lead to increased generic competition for ADDERALL XR inaddition to the authorized generic versions which already exist. In 2011authorized generic and generic versions of the Company's CARBATROL and REMINYLproducts, respectively were launched, which led to lower sales of these brandedproducts compared to the period before loss of exclusivity.

Shire is engaged in various legal proceedings with generic manufacturers with respect to its VYVANSE, INTUNIV, FOSRENOL, LIALDA and ADDERALL XR patents.

Products under development

The Company focuses its development resources on projects within its core therapeutic areas of ADHD, GI, HGT and RM, as well as early development projects in additional therapeutic areas. Total R&D expenditures of $770.7 million, $661.5 million and $639.9 million were incurred in the years to December 31, 2011, 2010 and 2009 respectively.

The table below lists the Company's products in clinical development as of December 31, 2011 by disease areas indicating the most advanced development status reached in key markets and the Company's territorial rights in respect of each product candidate.

Product Disease Development The Company's area status at territorial December rights 31, 2011

SPECIALTY PHARMACEUTICALS

Treatments for ADHD INTUNIV (extended ADHD Registration Global release guanfacine) in Canada (entered Phase 3 in Q1 2003)

VYVANSE/VENVANSE ADHD Registration Global (lisdexamfetamine in EU dimesylate) (entered Phase 3 in Q4 2008) INTUNIV ADHD Phase 3 in Global EU (entered Phase 3 in Q2 2010)

Guanfacine Carrier ADHD and other Phase 1 Global Wave CNS Disorders Treatments for GI diseases

LIALDA (mesalamine)/ Diverticulitis Phase 3 Global

MEZAVANT (mesalazine) globally (excluding (entered Italy and Phase 3 in Latin Q4 2007) America) (1)

RESOLOR (prucalopride) Chronic Phase 3 in Europe

Constipation EU (entered (Males) Phase 3 in Q4 2010)

RESOLOR (prucalopride) Chronic Phase US (5)

Constipation 3-ready in US SPD-557(M0003) Refractory Phase 2 EU and gastroesophageal North reflux disease America ("rGERD")

Treatments for diseases in other

therapeutic areas XAGRID Essential Phase 3 in Global thrombocythaemia Japan (entered Phase 3 in Q4 2010) VYVANSE Adjunctive Phase 3 Global (lisdexamfetamine therapy in Major (entered dimesylate) Depressive Phase 3 in Disorder ("MDD") Q4 2011) VYVANSE Excessive Phase 2 Global (lisdexamfetamine Daytime dimesylate) Sleepiness ("EDS") VYVANSE Negative Phase 2 Global (lisdexamfetamine Symptoms of dimesylate) Schizophrenia ("NSS") VYVANSE Other non ADHD Phase 2 Global (lisdexamfetamine indications in dimesylate) adults SPD-535 Arteriovenous Phase 1 Global grafts in hemodialysis patients HUMAN GENETIC THERAPIES Treatment for Fabry

REPLAGAL (agalsidase Fabry disease Registration in the US Global

alfa) (additional study initiated to support US dossier Q1 2010)(4)

Treatment for Duchenne Muscular

Dystrophy ("DMD") HGT-4510 DMD Phase 2a (currently Global on clinical hold) (Excluding North America) (2) ERTs

HGT-2310 Hunter Syndrome with Phase 1/ 2 Global (3) central nervous system ("CNS") symptoms, idursulfase-IT HGT-1410 Sanfilippo Syndrome Phase 1/ 2 Global (Mucopolysaccharidosis IIIA) HGT-1110 Metachromatic Preclinical Global Leukodystrophy ("MLD") HGT-3010 Sanfilippo Syndrome Preclinical Global (Mucopolysaccharidosis IIIB) REGENERATIVE MEDICINE Treatment for Diabetic Foot Ulcers DERMAGRAFT DFU Registration Global in Canada Treatment for Venous (dossier Leg Ulcers ("VLU") submitted for approval in Q1 DERMAGRAFT

2011) VLU Phase 3 Global (entered Phase 3 in Q2 2009)

1. Mochida Pharmaceutical Co., Ltd has rights to develop and sell LIALDA in

Japan under license with Shire.

2. As a result of a license and collaboration agreement with Acceleron Pharma

Inc ("Acceleron").

3. Genzyme has rights to manage marketing and distribution in Japan and

certain other Asia Pacific countries under a license with Shire.

4. REPLAGAL entered Phase 3 in Q4 1998 for registration outside the US.

5. US rights were acquired from J&J in January 2012.

Specialty PharmaceuticalsTreatments for ADHDINTUNIV for ADHD in Canada

In October 2011 Shire submitted a New Drug Submission ("NDS") seeking the approval in Canada for INTUNIV for the treatment of ADHD in children and adolescents aged 6 to 17. In December 2011, Health Canada accepted the NDS for screening.

VYVANSE/VENVANSE for ADHD in the EU

In December 2011 Shire submitted an MAA seeking approval for VYVANSE (to be marketed as VENVANSE) for the treatment of ADHD in children aged 6 to 17. In January 2012 the EMA accepted this MAA for review.

INTUNIV for ADHD in the EU

INTUNIV for the treatment of ADHD in children aged 6 to 17 in the EU is in Phase 3 development.

Guanfacine Carrier Wave for the treatment of various CNS disorders

A lead candidate has been selected for development and a Phase 1 program hasbeen initiated to determine safety and tolerability of this compound. Theongoing Phase 1 program will be supportive of potentially three differentCNS-related indications: ADHD, hyperactivity in Autism Spectrum Disorder andPediatric Anxiety.Treatments for GI diseases

LIALDA/MEZAVANT for the treatment of diverticulitis

Phase 3 worldwide clinical trials investigating the use of LIALDA/MEZAVANT to prevent recurrent attacks of diverticulitis were initiated in 2007 and are ongoing.

RESOLOR for the treatment of chronic constipation in males

A Phase 3 European clinical trial to further assess the efficacy of RESOLOR for the treatment of chronic constipation in males was initiated in 2010 and is ongoing.

RESOLOR for the treatment of chronic constipation in the US

On January 10, 2012, Shire announced that it acquired the rights to develop andmarket RESOLOR in the US in an agreement with Janssen Pharmaceutica N.V. Thisproduct is Phase 3-ready and definitive plans will be implemented followingdiscussions with regulatory authorities.

SPD-557 for the treatment of refractory GERD

SPD-557 (M0003) is a selective 5-HT4 receptor agonist. An exploratory Phase 2program to investigate the effect of the product on reflux episodes in patientscurrently treated with proton pump inhibitors was initiated in the fourthquarter 2010 and is ongoing.

Treatments for diseases in other therapeutic areas

XAGRID for the treatment of essential thrombocythaemia in Japan

A Phase 3 clinical program has been initiated to assess the safety and efficacyof XAGRID in adult essential thrombocythaemia patients treated withcytoreductive therapy who have become intolerant to their current therapy orwhose platelet counts have not been reduced to an acceptable level.

Lisdexamfetamine dimesylate (("LDX"), currently marketed as VYVANSE in the US for the treatment of ADHD) for the treatment of inadequate response in MDD

A Phase 3 clinical program to assess the efficacy and safety of LDX as adjunctive therapy in patients with MDD was initiated in the fourth quarter of 2011 and is ongoing.

LDX (currently marketed as VYVANSE in the US for the treatment of ADHD) for the treatment of EDS

Based on discussions with regulatory agencies regarding potential development pathways for LDX as a possible EDS treatment option, Phase 3 studies could begin in 2012.

LDX (currently marketed as VYVANSE in the US for the treatment of ADHD) for the treatment of NSS

Based on discussions with regulatory agencies regarding potential development pathways for LDX as a possible NSS treatment option, Phase 3 studies could begin in 2012.

LDX (currently marketed as VYVANSE in the US for the treatment of ADHD) for the treatment of other non ADHD indications in adults

Shire is conducting a Phase 2 pilot clinical trial to assess the efficacy and safety of LDX for the treatment of Binge Eating Disorder.

SPD-535 for the treatment of improvement in potency of arteriovenous access in hemodialysis patients

SPD-535 is in development as a novel molecule with platelet lowering abilityand without phosphodiesterase type III inhibition apparent at clinicallyrelevant doses. Data from Phase 1 clinical trials demonstrated positiveproof-of-principle. Work is ongoing on additional Phase 1 studies to supportprogression to a Phase 2 proof-of-concept program that will target preventionof thrombotic complications associated with arteriovenous access inhemodialysis patients.

Projects in pre-clinical development

A number of additional projects are underway in various stages of pre-clinicaldevelopment for the SP area, including programs using Carrier Wave technology.More data on these programs is expected throughout 2012.

Development projects discontinued in 2011

The Company has discontinued the following SP development projects during the year ended December 31, 2011:

* FOSRENOL for the treatment of pre-dialysis chronic kidney disease * JUVISTA for the improvement of scar appearance * SPD-556 for the treatment of ascites * Carrier Wave molecules for the treatment of pain * RESOLOR for the treatment of opioid-induced constipation

Human Genetic Therapies

Treatments for Fabry disease

REPLAGAL - for the treatment of Fabry disease in the US

On October 24, 2011 Shire initiated a rolling Biologics License Application("BLA") for REPLAGAL in the US, designated Fast Track by the FDA. The Companysubmitted the final BLA sections in November 2011. In 2010 Shire withdrew anearlier BLA in order to gather additional clinical data for REPLAGAL. Thesedata, including data from Shire's ongoing US treatment Protocol, have now beenevaluated and included in the new filing. The BLA has been accepted forPriority Review and assigned an action date of May 17, 2012.

Treatment for DMD

HGT-4510 for DMD

HGT-4510 (also referred to as ACE-031) was added to the Shire HGT portfolio in2010 through an exclusive license in markets outside of North America for theActRIIB class of molecules being developed by Acceleron. The lead ActRIIB drugcandidate, HGT-4510 is in development for the treatment of patients with DMD.The Phase 2a trial is on hold. Additional preclinical toxicology work will beconducted in 2012. This product has been granted orphan designation in the

USand the EU.ERT

HGT-2310 for the treatment of Hunter syndrome with CNS symptoms, idursulfase-IT (intrathecal delivery)

HGT-2310 is in development as an ERT delivered intrathecally for Hunter syndrome patients with CNS symptoms. The Company initiated a Phase 1/2 clinical trial in the first quarter of 2010. This trial is ongoing. This product has been granted orphan designation in the US.

HGT-1410 for Sanfilippo A Syndrome (Mucopolysaccharidosis IIIA)

HGT-1410 is in development as an ERT delivered intrathecally for the treatmentof Sanfilippo A Syndrome (Mucopolysaccharidosis IIIA), an LSD. The product hasbeen granted orphan drug designation in the US and in the EU. The Companyinitiated a Phase 1/2 clinical trial in August 2010. This trial is ongoing.

Early Research Products

HGT-3010 for Sanfilippo B Syndrome (Mucopolysaccharidosis IIIB)

HGT-3010 is in preclinical development as an ERT delivered intrathecally for the treatment of Sanfilippo B Syndrome (Mucopolysaccharidosis IIIB).

HGT-1110 - for the treatment of MLD

HGT-1110 is in preclinical development as an ERT delivered intrathecally forthe treatment of Metachromatic Leukodystrophy. This product has been grantedorphan drug designation in the US and the EU.

A number of additional early stage research projects are also underway for the HGT business area.

Regenerative MedicineTreatments for DFU

DERMAGRAFT - for the treatment of DFU

On March 21, 2011, prior to acquisition by the Company, ABH filed a Class IVMedical Device Application to Health Canada to seek approval for DERMAGRAFT

forthe treatment of DFU.Treatments for VLU

DERMAGRAFT - for the treatment of VLU

On August 24, 2011 Shire announced its preliminary analysis of the top-lineresults from ABH's Phase 3 pivotal trial of DERMAGRAFT in subjects with VLU.The international pivotal trial was designed as a prospective, multicenter,randomized, controlled clinical study to assess the product's safety andefficacy in the promotion of healing VLU. The preliminary analysis of the datawas that the trial did not meet the primary endpoint mutually agreed with theFDA and EMA and a subsequent detailed analysis of the data set is ongoing.

Business Development

Shire seeks to focus its business development activity on the acquisition andin-licensing of products and projects which have the benefit of long-termpatent protection and/or data exclusivity, other forms of market exclusivityand/or barriers to entry.Through the acquisition of ABH in 2011 Shire obtained DERMAGRAFT, which iscurrently marketed in the US for the treatment of DFU. Through the acquisitionof Movetis in 2010, Shire obtained the recently launched RESOLOR, a promisingGI pipeline and world-class R&D talent. In addition, in early 2012 Shireacquired the rights to market RESOLOR in the US. In 2010 Shire also acquired anexclusive license in markets outside of North America for the ActRIIB class ofmolecules being developed by Acceleron. The collaboration with Acceleron willinitially focus on further developing HGT-4510 (also called ACE-031) for thetreatment of patients with DMD.

In 2009, Shire acquired the worldwide rights (excluding the US, Canada and Barbados) to EQUASYM and EQUASYM XL from UCB and entered into a research collaboration with Santaris Pharma A/S ("Santaris") for the development of its Locked Nucleic Acid ("LNA") drug platform technology.

Organization and Structure

In the third quarter of 2011, following the acquisition of ABH, anorganizational realignment was carried out. Following this re-organization theCompany now has three business units and three reporting segments: SP, HGT andRM (which currently comprises only the ABH business).

During 2010, to support the Company's mission to increase the proportion of product sales generated outside of the US, Shire established an international commercial hub in Switzerland.

Results of operations for the year to December 31, 2011

The Company's management analyzes product sales and revenue growth for certainproducts sold in markets outside of the US on a constant exchange rate ("CER")basis, so that product sales and revenue growth can be considered excludingmovements in foreign exchange rates. Product sales and revenue growth on a CERbasis is a Non-GAAP financial measure ("Non-GAAP CER"), computed by comparing2011 product sales and revenues restated using 2010 average foreign exchangerates to 2010 actual product sales and revenues. This Non-GAAP financialmeasure is used by Shire's management, and is considered to provide usefulinformation to investors about the Company's results of operations, because itfacilitates an evaluation of the Company's year on year performance on acomparable basis. Average exchange rates for the year to December 31, 2011 were$1.60:£1.00 and $1.39:€1.00 (2010: $1.55:£1.00 and $1.33:€1.00).

Financial highlights for the year to December 31, 2011 are as follows:

* Product sales in 2011 were up 26% to $3,950 million (2010: $3,128 million).

On a CER basis, which is a Non GAAP measure, product sales were up 24%.

Product sales growth was generated from across the portfolio, particularlyVYVANSE (up 27% to $805 million), ADDERALL XR (up 48% to $533 million),REPLAGAL (up 35% to $475 million), ELAPRASE (up 15% to $465 million), LIALDA/MEZAVANT (up 27% to $372 million) and VPRIV (up 79% to $256 million). Productsales in 2011 also benefited from $105 million of DERMAGRAFT sales madesubsequent to the acquisition of ABH.

* Total revenues in 2011 exceeded $4 billion for the first time, increasing

by 23% (Non GAAP CER: up 21%) to $4,263 million (2010: $3,471 million). The

strong product sales growth more than offset decreased royalties and other

revenues, down 9% due to lower 3TC and ZEFFIX royalties. * Operating income was up 40% to $1,109 million (2010: $794 million), as total revenues grew at a faster rate than R&D and selling, general and administrative ("SG&A") expenditure. Operating income in 2010 included

impairment charges recorded on the divestment of DAYTRANA and an up-front

payment of $45 million to Acceleron.

* Diluted earnings per ordinary share were up 43% to 150.9c (2010: 105.3c)

due to higher operating income and a lower effective tax rate in 2011 of

21% (2010: 24%). Total revenuesThe following table provides an analysis of the Company's total revenues bysource:Year to December 31, 2011 2010 Change $'M $'M % __________________ __________________ __________________ Product sales 3,950.2 3,128.2 +26% Royalties 283.5 328.1 -14% Other revenues 29.7 14.8 +101% __________________ __________________ __________________ Total 4,263.4 3,471.1 +23% __________________ __________________ __________________Product sales Year to Year to December 31, December 31, Product sales Non-GAAP US Exit CER prescription market 2011 2010 growth growth growth1 share1 $'M $'M % % % % SP ADHD VYVANSE 805.0 634.2 +27 +27 +21 17 ADDERALL 532.8 360.8 +48 +47 +11 7XR INTUNIV 223.0 165.9 +34 +34 +78 4 EQUASYM 19.9 22.0 -10 -14 n/a2 n/a2 DAYTRANA - 49.4 n/a4 n/a4 n/a4 n/a GI LIALDA / 372.1 293.4 +27 +26 +9 21MEZAVANT PENTASA 251.4 235.9 +7 +7 -2 14 RESOLOR 6.1 0.3 n/a n/a n/a3 n/a3 General products FOSRENOL 166.9 182.1 -8 -11 -16 5 XAGRID 90.6 87.3 +4 -1 n/a n/a2 CARBATROL 52.3 82.3 -36 -36 -30 10 Other 95.5 105.6 -10 -13 n/a n/aproduct sales __________________ __________________ ______________ 2,615.6 2,219.2 +18 __________________ __________________ ______________ HGT REPLAGAL 475.2 351.3 +35 +30 n/a3 n/a3 ELAPRASE 464.9 403.6 +15 +12 n/a2 n/a2 VPRIV 256.2 143.0 +79 +76 n/a2 n/a2 FIRAZYR 33.0 11.1 +197 +188 n/a2 n/a2 __________________ __________________ ______________ 1,229.3 909.0 +35 __________________ __________________ ______________ RM DERMAGRAFT 105.3 - n/a n/a5 n/a2 n/a2 __________________ __________________ ______________ Total RM 105.3 - n/a product sales __________________ __________________ ______________ Total 3,950.2 3,128.2 +26 product sales __________________ __________________ ______________ (1) Data provided by IMS Health National Prescription Audit ("IMS NPA"). Exitmarket share represents the average US market share in the month ended December31, 2011.

(2) IMS NPA Data not available.

(3) Not sold in the US in the year to December 31, 2011.

(4) The Company divested DAYTRANA to Noven effective October 1, 2010.

(5) DERMAGRAFT was acquired by Shire on June 28, 2011.

Specialty Pharmaceuticals

VYVANSE - ADHD

VYVANSE product sales grew strongly in 2011 as a result of higher prescriptiondemand, due to an increase in VYVANSE's market share and growth in US ADHDmarket (10%), and the effect of a price increase taken in 2011. These factorsmore than offset the effect of de-stocking and higher sales deductions in 2011compared to 2010.

Litigation proceedings regarding VYVANSE are ongoing.

ADDERALL XR - ADHD

ADDERALL XR product sales grew by 48%, or $172 million, principally as a resultof lower sales deductions as a percentage of branded gross product sales,increases in US prescription demand (in line with growth in the US ADHD market)and a price increase taken during 2011.Sales deductions in 2011 represented 57% of branded gross product sales (2010:65% of branded gross product sales). The decrease in sales deductions wasprimarily due to the lowering of our estimate of inventory in the US retailpipeline and the related sales deduction reserve in the third quarter of 2011(representing 2% of gross product sales in 2011) and the mix of customer salesaffecting the rebate calculation. The eight percentage point decrease in salesdeductions (as a percentage of branded gross product sales) contributed $85million to ADDERALL XR's net product sales in 2011. ADDERALL XR salesdeductions in 2012 are expected to be in the range of 60-65%.There are potentially different interpretations as to how shipments ofauthorized generic ADDERALL XR to Teva and Impax should be included in theMedicaid rebate calculation. Since authorized generic launch in 2009 theCompany has recorded its accrual for Medicaid rebates based on its bestestimate of the rebate payable, consistent with the Company's interpretation ofthe Medicaid rebate legislation. Shire believes that its interpretation of theMedicaid rebate legislation is reasonable and correct. Additionally, fromOctober 1, 2010 forward, provisions of the 2010 Affordable Care Act providefurther clarity, in a manner consistent with the Company's interpretation, asto how shipments of authorized generics from that date should be included inthe Medicaid rebate calculation.The CMS could disagree with Shire's interpretation of the Medicaid rebatelegislation for shipments of authorized generic products prior to October 1,2010. CMS could require Shire to apply an alternative interpretation of theMedicaid rebate legislation and request that Shire pays up to $212 millionabove the recorded liability. However, Shire believes it has a strong legalbasis supporting its interpretation of the Medicaid rebate legislation, andthat there would be a strong basis to limit any additional payment to a levelapproximating the full, un-rebated cost to the States of ADDERALL XR(equivalent to approximately $134 million above the recorded liability), and toinitiate litigation to recover any amount paid in excess of the recordedliability. The result of any such litigation cannot be predicted.

Litigation proceedings regarding ADDERALL XR are ongoing.

INTUNIV - ADHD

INTUNIV product sales were up 34% compared to 2010, primarily driven by significant growth in US prescription demand together with a price increase taken during 2011. These positive factors were offset by lower stocking and higher sales deductions in 2011 compared to 2010, and the effect of the inclusion of launch stocking shipments within reported 2010 product sales.

Litigation proceedings relating to the Company's INTUNIV patents are in progress.

LIALDA/MEZAVANT - Ulcerative colitis

The growth in product sales for LIALDA/MEZAVANT in 2011 was primarily driven byhigher US prescription demand following increases in US market share, a priceincrease taken since the fourth quarter of 2010 and the effect of stocking in2011 compared to de-stocking in 2010.

Litigation proceedings regarding LIALDA/MEZAVANT are ongoing.

PENTASA - Ulcerative colitis

Product sales of PENTASA continued to grow despite lower US prescription demand, due to the impact of a price increase taken during 2011.

FOSRENOL - Hyperphosphatemia

Product sales of FOSRENOL outside the US decreased marginally primarily becauseof mandatory price reductions that were imposed in several key markets. Productsales of FOSRENOL in the US decreased due to lower US prescription demand andhigher sales deductions compared to 2010, which more than offset a 2011 priceincrease.

Litigation proceedings regarding Shire's FOSRENOL patents are ongoing.

Human Genetic Therapies

REPLAGAL - Fabry disease

The 35% growth (30% on a Non GAAP CER basis) in REPLAGAL product sales wasdriven by the treatment of new patients, being both na¯ve patients and switchesfrom patients being treated with FABRAZYME. Reported REPLAGAL sales alsobenefited from favorable foreign exchange, due to the weaker US dollar over thecourse of 2011 compared to 2010.

Litigation proceedings regarding REPLAGAL are ongoing.

ELAPRASE - Hunter syndrome

Product sales for ELAPRASE increased as a result of increased patients on therapy across all regions in which ELAPRASE is sold. Reported ELAPRASE sales also benefited from favorable foreign exchange.

VPRIV - Gaucher disease

VPRIV product sales growth was driven by the treatment of new patients, beingboth na¯ve patients and patients switching from CEREZYME. Reported sales alsobenefited from favorable foreign exchange.

FIRAZYR - HAE

The significant growth rate in global product sales in 2011 follows the successful launch of FIRAZYR in the US in August 2011 and the approval for self-administration in the EU in March 2011.

Regenerative Medicine

DERMAGRAFT - DFU

DERMAGRAFT continues to see strong revenue growth in the US, up 33% for thefull year 2011 compared to the full year 2010(1). The growth resulted from acombination of an expanding US diabetic population, continued adoption ofDERMAGRAFT as a treatment for DFU, and the continued investment in marketingprograms and additional sales representatives to market the product.(1) Shire acquired DERMAGRAFT through its acquisition of ABH in June 2011.

Royalties Year to Year to December 31, December 31, 2011 2010 Change $'M $'M % ____________ ____________ ___________ ADDERALL XR 107.1 100.3 +7% 3TC and ZEFFIX 82.7 154.0 -46% FOSRENOL 46.5 26.8 +74% Other 47.2 47.0

Royalty income decreased in 2011 compared to 2010 as lower royalties from 3TC and ZEFFIX more than offset higher royalty income from ADDERALL XR and FOSRENOL.

Royalty income from 3TC and ZEFFIX continues to be adversely impacted byincreased competition from other products. Additionally, with effect from thesecond quarter of 2011, Shire has not recognized royalty income for 3TC andZEFFIX in certain territories due to a disagreement between GSK and Shire abouthow the relevant royalty rates should be applied given the expiry dates ofcertain patents. GSK and Shire are holding discussions in order to seek toresolve the disagreement. In 2012 royalty terms for 3TC and ZEFFIX will beginto expire in most territories outside of the US, and in the US royalty termsfor 3TC and ZEFFIX expire between 2014 and 2018. After expiry the Company willcease to receive royalties from GSK on sales of 3TC and ZEFFIX in thoseterritories.

Cost of product sales

Cost of product sales increased to $588.1 million for the year to December 31,2011 (15% of product sales), up from $463.4 million in the corresponding periodin 2010 (15% of product sales).Cost of product sales as a percentage of product sales stayed constant as theeffect of slightly higher margins from existing products and lower costsincurred on the transfer of manufacturing from Owings Mills in 2011 were offsetby the inclusion of DERMAGRAFT (including the unwind of the fair valueadjustment for inventory acquired with ABH) and a write down of expiredELAPRASE unpurified bulk material which was not prioritised for purification ascapacity was directed towards meeting demand for REPLAGAL and VPRIV in 2011.

For the year to December 31, 2011 cost of product sales included depreciation of $39.8 million (2010: $38.1 million).

R&D

R&D expenditure for the year to December 31, 2011 increased to $770.7 million(20% of product sales), compared to $661.5 million in the corresponding periodin 2010 (21% of product sales).R&D in 2010 included an up-front payment of $45.0 million (representing 1% ofproduct sales) on entering the collaboration with Acceleron for development ofthe ActRIIB class of molecules. Excluding this up-front payment, R&D increasedby $154.2 million in 2011, reflecting the Company's continued investment in anumber of targeted R&D programs, including new uses for VYVANSE, Sanfilippo andother development programs. In addition, R&D in 2011 also included a full yearof Movetis's development programs and ABH's expenditure in the second half of2011, an impairment charge of $16.0 million (2010: $nil) in respect of certainIPR&D assets and the adverse impact of foreign exchange in 2011 compared to2010.

For the year to December 31, 2011 R&D included depreciation of $25.2 million (2010: $19.0 million) and an impairment charge of $16.0 million (2010: $nil).

SG&A

SG&A expenses increased to $1,751.4 million (44% of product sales) for the year to December 31, 2011 from $1,526.3 million (49% of product sales) in the corresponding period in 2010.

In 2010 SG&A included an impairment charge of $42.7 million to write down theDAYTRANA intangible asset to its fair value less costs to sell, prior to thedivestment of DAYTRANA to Noven. Excluding this impairment charge SG&Aincreased by $267.8 million as the Company supported the growth of its existingand recently launched products along with developing its internationalinfrastructure. SG&A in 2011 also included a full year of Movetis's operatingcosts, ABH's expenditure in the second half of 2011 and the adverse impact offoreign exchange in 2011 compared to 2010.

For the year to December 31, 2011 SG&A also included depreciation of $63.1 million (2010: $62.1 million) and intangible asset amortization of $165.0 million (2010: $133.5 million).

Reorganization costs

For the year to December 31, 2011 Shire recorded reorganization costs of $24.3million (2010: $34.3 million) relating to the transfer of manufacturing fromits Owings Mills facility to a third party and the establishment of aninternational commercial hub in Switzerland.

Integration and acquisition costs

For the year to December 31, 2011 Shire recorded integration and acquisitioncosts of $13.7 million (2010: $8.0 million), which related to the acquisitionand integration of ABH ($13.6 million) and the integration of Movetis ($8.3million), offset by an adjustment to contingent consideration payable forEQUASYM ($8.2 million). In 2010 integration and acquisition costs primarilyrelated to the acquisition of Movetis.

Interest expense

For the year to December 31, 2011 Shire incurred interest expense of $39.1 million (2010: $35.1 million). Interest expense principally relates to the coupon and amortization of issue costs on Shire's $1,100 million 2.75% convertible bonds due 2014.

Other income/(expense), net

For the year to December 31, 2011 the Company recognized other income, net of$18.1 million (2010: $7.9 million). Other income in the year to December 31,2011 included a gain of $23.5 million arising on the disposal of substantiallyall of Shire's holding in Vertex (Shire received these shares as partialconsideration for its investment in ViroChem following ViroChem being acquiredby Vertex). Other income in the year to December 31, 2010 included a gain of$11.1 million arising on the disposal of Shire's investment in Virochem.

Taxation

The effective rate of tax in 2011 was 21% (2010: 24%).

The effective tax rate in 2011 is lower than 2010 due to favorable changes inprofit mix in 2011, including the full year effect in 2011 of the Company'sestablishment of an international commercial hub in Switzerland in the fourthquarter of 2010, together with the effect of certain expenses in 2010(including the up-front payment to Acceleron) being incurred in territorieswith a tax rate lower than Shire's effective tax rate.

Financial condition at December 31, 2011

Cash & Cash equivalents

Cash and cash equivalents increased by $69.4 million to $620.0 million(December 31, 2010: $550.6 million). Cash generated by operating activities of$1,073.6 million and proceeds of $106.0 million on disposal of non-currentinvestments and PP&E were offset by the cost of acquiring ABH, other capitalexpenditure, the purchase of shares by the Employee Share Ownership Trust("ESOT") and dividend payments.

Accounts receivable, net

Accounts receivable, net increased by $152.5 million to $845.0 million (December 31, 2010: $692.5 million) due to increased total revenues in the year to December 31, 2011. Days sales outstanding remained constant at 50 days (December 31, 2010: 50 days).

Investments

Investments decreased by $71.7 million to $29.9 million (December 31, 2010: $101.6 million) due to the disposal of substantially all of the Company's holding in Vertex for a cash consideration of $94.7 million.

Goodwill

Goodwill has increased by $190.1 million to $592.6 million (December 31, 2010: $402.5 million), principally due to goodwill arising on the acquisition of ABH.

Other Intangible assets, net

Other intangible assets have increased by $514.1 million to $2,493.0 million(December 31, 2010: $1,978.9 million), principally due to intangible assets forDERMAGRAFT product technology of $710.0 million acquired with ABH, offset byintangible asset amortization and impairment charges of $182.7 million.

Convertible bonds - current

Convertible bonds - current have increased by $1,100 million due to thereclassification of the Company's $1,100 million 2.75% convertible bonds due2014 and convertible into fully paid ordinary shares of Shire plc (the "Bonds")from non-current to current liabilities in 2011, as the exercise of the PutOption (see "Liquidity and Capital Resources", below) could require the Companyto redeem the Bonds in 2012. The Company does not consider it likely that thePut Option will be exercised in 2012. However, if the Bonds were redeemed infull in 2012, the Company's operating cash flow together with available cash,cash equivalents and the new RCF (see "Liquidity and capital resources", below)would be sufficient to fund repayment of the Bonds. In lieu of settling anysuch redemption wholly in cash, the terms of the Bonds also permit the Companyto deliver the underlying ordinary shares and, if necessary, a cash top-upamount.

Liquidity and capital resources

General

The Company's funding requirements depend on a number of factors, including thetiming and extent of its development programs; corporate, business and productacquisitions; the level of resources required for the expansion of certainmanufacturing and marketing capabilities as the product base expands; increasesin accounts receivable and inventory which may arise with any increase inproduct sales; competitive and technological developments; the timing and costof obtaining required regulatory approvals for new products; the timing andquantum of milestone payments on collaborative projects; the timing and quantumof tax and dividend payments; the timing and quantum of purchases by the ESOTof Shire ordinary shares or ADSs in the market to satisfy option exercises; thetiming and quantum of any amount that could be paid by the Company if CMS wereto employ an alternative interpretation of the Medicaid rebate legislation inrespect of ADDERALL XR Medicaid rebates for periods prior to October 1, 2010;and the amount of cash generated from sales of Shire's products and royaltyreceipts.

An important part of Shire's business strategy is to protect its products and technologies through the use of patents, proprietary technologies and trademarks, to the extent available. The Company intends to defend its intellectual property and as a result may need cash for funding the cost of litigation.

The Company finances its activities through cash generated from operating activities, credit facilities, private and public offerings of equity and debt securities, and the proceeds of asset or investment disposals.

Shire's balance sheet includes $620.0 million of cash and cash equivalents atDecember 31, 2011. Substantially all of Shire's debt relates to its $1,100million 2.75% Convertible Bond which matures in 2014, although these Bondsinclude a Put Option (as defined below) which could require repayment of theBonds in May 2012. In addition, Shire has committed multicurrency revolving andswing line facilities of $1,200 million, which mature in 2015, and arecurrently undrawn.

Shire 2.75% Convertible Bonds due 2014

On May 9, 2007 Shire issued the Bonds and the net proceeds of the issuance,after deducting the commissions and other direct costs of issue, totaled$1,081.7 million. In connection with the Scheme the Trust Deed was amended andrestated in 2008 in order to provide that, following the substitution of Shireplc in place of Shire Biopharmaceuticals Holdings as the principal obligor andissuer of the Bonds, the Bonds would be convertible into ordinary shares ofShire plc.The Bonds were issued at 100% of their principal amount, and unless previouslypurchased and cancelled, redeemed or converted, will be redeemed on May 9, 2014(the "Final Maturity Date") at their principal amount.The Bonds bear interest at 2.75% per annum, payable semi-annually in arrears onNovember 9 and May 9. The Bonds constitute direct, unconditional,unsubordinated and unsecured obligations of the Company, and rank pari passuand ratably, without any preference amongst themselves, and equally with allother existing and future unsecured and unsubordinated obligations of theCompany.The Bonds may be redeemed at the option of the Company, at their principalamount together with accrued and unpaid interest if: (i) at any time after May23, 2012 if on no less than 20 dealing days in any period of 30 consecutivedealing days the value of Shire's ordinary shares underlying each Bond in theprincipal amount of $100,000 would exceed $130,000; or (ii) at any timeconversion rights have been exercised, and/or purchases and correspondingcancellations, and/or redemptions effected in respect of 85% or more inprincipal amount of Bonds originally issued. The Bonds may also be redeemed atthe option of the Bond holder at their principal amount including accrued butunpaid interest on May 9, 2012 (the "Put Option"), or following the occurrenceof a change of control of Shire. The Bonds are repayable in US dollars, butalso contain provisions entitling the Company to settle redemption amounts inPounds sterling, or in the case of the Final Maturity Date and followingexercise of the Put Option, by delivery of the underlying ordinary shares and acash top-up amount. At February 21, 2012 the Bonds were trading at above par,and the Company does not currently consider it likely that the Put Option willbe exercised in 2012. However, in accordance with US GAAP, as the exercise ofthe Put Option could require the Company to redeem the Bonds within 12 monthsof the balance sheet date, the Bonds have been presented as a current liabilityat December 31, 2011.The Bonds are convertible into ordinary shares during the conversion period,being the period from June 18, 2007 until the earlier of: (i) the close ofbusiness on the date falling 14 days prior to the Final Maturity Date; (ii) ifthe Bonds have been called for redemption by the Company, the close of business14 days before the date fixed for redemption; (iii) the close of business onthe day prior to a Bond holder giving notice of redemption in accordance withthe conditions; and (iv) the giving of notice by the trustee that the Bonds areaccelerated by reason of the occurrence of an event of default.

Upon conversion, the Bond holder is entitled to receive ordinary shares at the conversion price of $32.83 per ordinary share, (subject to adjustment as outlined below).

The conversion price is subject to adjustment in respect of (i) any dividend ordistribution by the Company, (ii) a change of control and (iii) customaryanti-dilution adjustments for, inter alia, share consolidations, share splits,spin-off events, rights issues, bonus issues and reorganizations. The initialconversion price of $33.5879 was adjusted to $33.17 with effect from March 11,2009 as a result of cumulative dividend payments during the period from October2007 to April 2009 inclusive, and was further adjusted to $32.83 with effectfrom March 11, 2011 as a result of cumulative dividend payments during theperiod April 2009 to April 2011 inclusive. The ordinary shares issued onconversion will be delivered credited as fully paid, and will rank pari passuin all respects with all fully paid ordinary shares in issue on the relevantconversion date.

Revolving Credit Facilities Agreement

On November 23, 2010 the Company entered into a committed multicurrencyrevolving and swingline facilities agreement with a number of financialinstitutions, for which Abbey National Treasury Services plc (trading asSantander Global Banking and Markets), Bank of America Securities Limited,Barclays Capital, Citigroup Global Markets Limited, Lloyds TSB Bank plc and TheRoyal Bank of Scotland plc acted as mandated lead arrangers and bookrunners(the "new RCF"). The new RCF is for an aggregate amount of $1,200 million andcancelled the Company's then existing committed revolving credit facility. Thenew RCF, which includes a $250 million swingline facility, may be used forgeneral corporate purposes and matures on November 23, 2015.The interest rate on each loan drawn under the new RCF for each interest periodis the percentage rate per annum which is the aggregate of the applicablemargin (ranging from 0.90 to 2.25 per cent per annum) and LIBOR for theapplicable currency and interest period. Shire also pays a commitment fee onundrawn amounts at 35 per cent per annum of the applicable margin.Under the new RCF it is required that (i) Shire's ratio of Net Debt to EBITDA(as defined within the new RCF agreement) does not exceed 3.5 to 1 for eitherthe 12 month period ending December 31 or June 30 unless Shire has exercisedits option (which is subject to certain conditions) to increase it to 4.0 to 1for two consecutive testing dates; (ii) the ratio of EBITDA to Net Interest (asdefined in the new RCF agreement) must not be less than 4.0 to 1, for eitherthe 12 month period ending December 31 or June 30, and (iii) additionallimitations on the creation of liens, disposal of assets, incurrence ofindebtedness, making of loans, giving of guarantees and granting security overassets. These financial and operating covenants have not had, and are notexpected to have, an effect on the Company's financial position and liquidity.

On entering into the new RCF in November 2010 the Company paid arrangement costs of $8.0 million, which have been recorded as deferred charges, with amortization of these costs to the Company's income statement over the contractual term of the new RCF. The availability of the loans under the RCF is subject to customary conditions.

Financing

Shire anticipates that its operating cash flow together with available cash,cash equivalents and the new RCF will be sufficient to meet its anticipatedfuture operating expenses, capital expenditures, tax and interest payments andlease obligations as they become due over the next twelve months.The Company anticipates that its operating cash flow together with availablecash, cash equivalents and the new RCF would be sufficient to enable repaymentof the Bonds if the Put Option was exercised in 2012. In lieu of settling anysuch redemption wholly in cash, the terms of the Bonds also permit the Companyto deliver the underlying ordinary shares and, if necessary, a cash top-upamount.If the Company decides to acquire other businesses, it expects to fund theseacquisitions from existing cash resources, the new RCF and possibly through newborrowings and the issue of new equity if necessary.

Sources and uses of cash

The following table provides an analysis of the Company's gross and net debt (excluding restricted cash), as at December 31, 2011 and 2010:

2011 2010 December 31, $'M $'M _________________ _________________ Cash and cash equivalents1 620.0 550.6 _________________ _________________ Shire 2.75% Convertible Bonds 1,100.0 1,100.0 Building financing obligation 8.2 8.4 _________________ _________________ Total debt 1,108.2 1,108.4 _________________ _________________ Net debt (488.2) (557.8) _________________ _________________(1) Substantially all of the Company's cash and cash equivalents are held byforeign subsidiaries (i.e, those subsidiaries incorporated outside of Jersey,Channel Islands, the jurisdiction of incorporation of Shire plc, Shire'sholding company). The amount of cash and cash equivalents held by foreignsubsidiaries has not had, and is not expected to have, a material impact on theCompany's liquidity and capital resources.

Cash flow activity

Net cash provided by operating activities for the year to December 31, 2011increased by $118.7 million or 12% to $1,073.6 million (2010: $954.9 million).Higher cash receipts from gross product sales and lower cash tax payments wereoffset by the timing and quantum of both sales deduction and operatingexpenditure payments, and lower royalty receipts in 2011 compared to 2010.Net cash provided by operating activities for the year to December 31, 2010increased by $328.0 million to $954.9 million (2009: $626.9 million), primarilydue to higher cash receipts from product sales and royalties, cash inflows fromforward foreign exchange contracts in 2010 compared to outflows in 2009,partially offset by higher payments on sales deductions, operating costs andtaxes in the year to December 31, 2010 compared to the same period in 2009.Net cash used in investing activities was $809.2 million in the year toDecember 31, 2011, principally relating to the cash paid (net of cash acquired)of $725.0 million for the acquisition of ABH and expenditure on property, plantand equipment of $194.3 million, offset by proceeds of $94.7 million receivedon the disposal of substantially all of Shire's holding in Vertex. Capitalexpenditure on property, plant and equipment includes $110.0 million onconstruction work at HGT's facility at Lexington Technology Park ("LTP").Net cash used in investing activities was $797.4 million in the year toDecember 31, 2010. This included the cash paid (net of cash acquired) of $449.6million for, and payments of $33.4 million on foreign exchange contractsrelated to, the acquisition of Movetis in October 2010, and expenditure onproperty, plant and equipment of $326.6 million. Capital expenditure onproperty, plant and equipment includes $121.9 million for the acquisition ofnew properties and properties previously occupied under operating leases and$134.5 million on construction work, at LTP.

Net cash used in financing activities was $195.4 million for the year to December 31, 2011, principally due to dividend payments, the purchase of shares by the ESOT and the repayment of debt acquired with ABH, offset by the tax benefit associated with the exercise of stock options.

Net cash used in financing activities was $99.5 million for the year to December 31, 2010, including dividend payments of $62.0 million and $43.1 million to extinguish building finance obligations at LTP.

Outstanding Letters of credit

At December 31, 2011, the Company had irrevocable standby letters of credit andguarantees with various banks totaling $34.7 million, providing security forthe Company's performance of various obligations. These obligations areprimarily in respect of the recoverability of insurance claims, leaseobligations and supply commitments. The Company has restricted cash of $9.2million, as required by these letters of credit.

Cash requirements

At December 31, 2011 the Group's cash requirement for long-term liabilities reflected on the balance sheet and other contractual obligations were as follows:

Payments due by period Less than More than Total 1 year 1 - 3 years 3 - 5 years 5 years $'M $'M $'M $'M $'M _______________ _______________ _______________

_______________ ______________

Convertible Bonds1 1,175.7 30.3 1,145.4 - Operating leases 182.9 43.5 61.6 36.4 41.4 obligation2 Purchase obligations3 669.9 534.2 119.7 14.1 1.9

Other long-term liabilities 131.8 1.2 127.9

1.3 1.4 reflected on the Balance sheet4 _______________ _______________ _____________ _____________ ______________ Total 2,160.3 609.2 1,454.6 51.8 44.7 _______________ _______________ _____________ _____________ ______________(1) Shire's $1,100 million principal amount of 2.75% convertible bonds due 2014and the interest on the Bonds has been included based on their contractualpayment dates. The principal amount of $1,100 million has been included withinpayments due in one to three years based on the Final Maturity Date of theBonds. The bondholders have a Put Option which would require the Company toredeem the Bonds at their principal amount in May 2012, and the Company has theoption to call the Bonds subject to certain conditions after May 2012. As aresult of the Put Option the Bonds have been classified as a current liabilityat December 31, 2011: nevertheless, the Company does not currently consider itlikely that the Put Option will be exercised in 2012. Further details areincluded within Liquidity and capital resources: Shire 2.75% Convertible Bondsdue 2014 above.

(2) The Company leases certain land, facilities, motor vehicles and certain equipment under operating leases expiring through 2021.

(3) Purchase obligations include agreements to purchase goods, investments orservices (including clinical trials, contract manufacturing and capitalequipment), including open purchase orders, that are enforceable and legallybinding and that specify all significant terms. Shire expects to fund thesecommitments with cash flows from operating activities.

(4) Unrecognized tax benefits and associated interest and penalties of $79.7 million are included within payments due in one to three years.

The contractual obligations table above does not include certain milestones andother contractual commitments where payment is contingent upon the occurrenceof events which are yet to occur (and therefore payment is not yet due). Themost significant of the Company's milestone and contractual commitments whichare contingent on the occurrence of future events are as follows:

Collaboration with Acceleron Pharma Inc. ("Acceleron") for activin receptor type IIB ("ActRIIB") class of molecules

On September 9, 2010 Shire announced that it had expanded its HGT pipeline byacquiring an exclusive license in markets outside of North America for theActRIIB class of molecules being developed by Acceleron. The collaboration willinitially focus on further developing HGT-4510 (also called ACE-031), the leadActRIIB drug candidate, which is in development for the treatment of patientswith Duchenne muscular dystrophy ("DMD"). The Phase 2a trial is on hold andclinical safety is under review. HGT-4510 and the other ActRIIB class ofmolecules have the potential to be used in other muscular and neuromusculardisorders with high unmet medical need.

In the year to December 31, 2010 Shire made an up-front payment of $45 million to Acceleron which has been expensed to R&D.

In the year to December 31, 2011 Shire's share of R&D costs under thiscollaboration agreement was $10.1 million (2010: $2.7 million; 2009: $nil)which were expensed to R&D. Shire will pay Acceleron up to a further $165.0million, subject to certain development, regulatory and sales milestones beingmet for HGT-4510 in DMD, up to an additional $288 million for successfulcommercialization of other indications and molecules, and royalties on productsales.

Shire and Acceleron will conduct the collaboration through a joint steering committee, with subcommittees including a joint manufacture committee, and a joint patent committee to monitor the development of HGT-4510 and other compounds.

Research collaboration with Santaris Pharma A/S ("Santaris") on Locked Nucleic Acid ("LNA") Drug Platform

On August 24, 2009 Shire announced that it had entered into a researchcollaboration with Santaris, to develop its proprietary LNA technology in arange of rare diseases. LNA technology has the benefit of shortened targetvalidation and proof of concept, potentially increasing the speed and loweringthe cost of development. As part of the joint research project Santaris willdesign, develop and deliver pre-clinical LNA oligonucleotides forShire-selected orphan disease targets, and Shire will have the exclusive rightto further develop and commercialize these candidate compounds on a worldwidebasis.

In the year to December 31, 2009 Shire made an up-front payment to Santaris of $6.5 million, for technology access and R&D funding, which was expensed to R&D.

In the year to December 31, 2011 Shire paid success milestones and othersupport costs of $2.5 million (2010: $4.0 million; 2009: $nil) and $5.3 million(2010: $2.3 million; 2009: $0.1 million) to Santaris respectively, which wereexpensed to R&D. Shire has remaining obligations to pay Santaris $13.5 millionsubject to certain success criteria, and development and sales milestones up toa maximum of $70.5 million for each indication. Shire will also pay single ordouble digit tiered royalties on net sales of the product.

Shire and Santaris have formed a joint research committee to monitor R&D activities through preclinical lead candidate selection at which point all development and commercialization costs will be the responsibility of Shire.

Collaboration and license agreement with Sangamo BioSciences, Inc ("Sangamo") to develop therapeutics for hemophilia

On February 1, 2012 Shire and Sangamo announced that they have entered into acollaboration and license agreement to develop therapeutics for hemophilia andother monogenic diseases based on Sangamo's zinc finger DNA-binding protein("ZFP") technology. Shire will receive exclusive world-wide rights to ZFPTherapeutics® designed to target four genes in hemophilia and will also receivethe right to designate three additional gene targets. Sangamo is responsiblefor all activities through submission of Investigational New Drug Applicationsand European Clinical Trial Applications for each product and Shire willreimburse Sangamo for its internal and external research program-related costs.Shire is responsible for clinical development and commercialization of productsarising from the alliance. Shire will pay Sangamo an up-front fee followed byresearch, regulatory, development and commercial milestone payments, androyalties on product sales.

Treasury policies and organization

The Company's principal treasury operations are coordinated by its corporatetreasury function. All treasury operations are conducted within a framework ofpolicies and procedures approved annually by the Board of Directors. As amatter of policy, the Company does not undertake speculative transactions thatwould increase its credit, currency or interest rate exposure.

Interest rate risk

The Company is exposed to interest rate risk on restricted cash, cash and cashequivalents and on foreign exchange contracts on which interest is at floatingrates. This exposure is primarily to US dollar, Pounds sterling and Eurointerest rates. As the Company maintains all of its cash, liquid investmentsand foreign exchange contracts on a short term basis for liquidity purposes,this risk is not actively managed. In the year to December 31, 2011 the averageinterest rate received on cash and liquid investments was less than 1% perannum. The largest proportion of these cash and liquid investments was in USdollar money market and liquidity funds.

The Company incurs interest at a fixed rate of 2.75% on $1,100 million in principal amount convertible bonds due 2014.

No derivative instruments were entered into during the year to December 31, 2011 to manage interest rate exposure. The Company continues to review its interest rate risk and the policies in place to manage the risk.

Foreign exchange risk

The Company trades in numerous countries and as a consequence has transactional and translational foreign exchange exposures.

Transactional exposure arises where transactions occur in currencies differentto the functional currency of the relevant subsidiary. The main tradingcurrencies of the Company are the US dollar, Pounds Sterling, Swiss Franc andthe Euro. It is the Company's policy that these exposures are minimized to theextent practicable by denominating transactions in the subsidiary's functionalcurrency.Where significant exposures remain, the Company uses foreign exchange contracts(being spot, forward and swap contracts) to manage the exposure for balancesheet assets and liabilities that are denominated in currencies different tothe functional currency of the relevant subsidiary. These assets andliabilities relate predominantly to intercompany financing, accruals forroyalty receipts and specific external receivables. The foreign exchangecontracts have not been designated as hedging instruments. Cash flows fromderivative instruments are presented within net cash provided by operatingactivities in the consolidated cash flow statement, unless the derivativeinstruments are economically hedging specific investing or financingactivities.

Translational foreign exchange exposure arises on the translation into US dollars of the financial statements of non-US dollar functional subsidiaries.

At December 31, 2011 the Company had 20 swap and forward foreign exchangecontracts outstanding to manage currency risk. The swaps and forward contractsmature within 90 days. The Company did not have credit risk related contingentfeatures or collateral linked to the derivatives. At December 31, 2011 the fairvalue of these contracts was a net asset of $3.0 million. Further details areincluded below.

Foreign exchange risk sensitivity

The following exchange rate sensitivity analysis summarises the sensitivity ofour reported revenues and net income to hypothetical changes in the averageannual exchange rates of the Euro, Pound Sterling and Swiss Franc against theUS Dollar, (assuming a hypothetical 10% strengthening of the US Dollar againsteach of the aforementioned currencies in the year to December 31, 2011): Increase/(reduction) Increase/(reduction) in net in revenues income $M $M Euro (64) (32) Pound Sterling (21) 10 Swiss Franc - 15

A 10% weakening of the US Dollar against the aforementioned currencies would have an equal and opposite effect.

The table below provides information about the Company's swap and forward foreign exchange contracts by currency pair. The table presents the net principal amounts and weighted average exchange rates of all outstanding contracts. All contracts have a maturity date of less than three months.

December 31, 2011 Principal Value of Weighted Amount Average Fair Receivable Exchange Rate Value $'M $'M _______________ _______________ _______________

Swap foreign exchange contracts

Receive USD/Pay EUR 203.5 1.32 3.4 Receive GBP/Pay USD 80.7 1.56 (0.4) Receive CAD/Pay USD 51.7 0.98 - Receive USD/Pay SEK 4.9 6.91 - Receive USD/Pay AUD 1.5 1.00 - Receive USD/Pay CHF 4.7 1.07 - Concentration of credit riskFinancial instruments that potentially expose Shire to concentrations of creditrisk consist primarily of short-term cash investments, trade accountsreceivable and derivative contracts. Cash is invested in short-term moneymarket instruments, including money market and liquidity funds and bank termdeposits. The money market and liquidity funds in which Shire invests are alltriple A rated by both Standard and Poor's and by Moody's credit ratingagencies.The Company is exposed to the credit risk of the counterparties with which itenters into derivative instruments. The Company limits this exposure through asystem of internal credit limits which require counterparties to have a longterm credit rating of A- / A3 or better from the major rating agencies. Theinternal credit limits are approved by the Board and exposure against theselimits is monitored by the corporate treasury function. The counterparties tothese derivatives contracts are major international financial institutions.The Company's revenues from product sales in the US are mainly governed byagreements with major pharmaceutical wholesalers and relationships with otherpharmaceutical distributors and retail pharmacy chains. For the year toDecember 31, 2011 there were three customers in the US that accounted for 49%of the Company's product sales. However, such customers typically havesignificant cash resources and as such the risk from concentration of credit isconsidered acceptable. The Company has taken positive steps to manage anycredit risk associated with these transactions and operates clearly definedcredit evaluation procedures. However, an inability of one or more of thesewholesalers to honor their debts to the Company could have an adverse effect onour financial condition and results of operations.A substantial portion of the Company's accounts receivable in countries outsideof the US is derived from product sales to government-owned orgovernment-supported healthcare providers. The Company's recovery of theseaccounts receivable is therefore dependent upon the financial stability andcreditworthiness of the relevant governments. In 2011 the creditworthiness andgeneral economic condition of a number of Eurozone countries (including Greece,Ireland, Italy, Portugal and Spain) has continued to deteriorate. As a result,in some of these countries the Company is experiencing delays in the remittanceof receivables due from government-owned or government-supported healthcareproviders.The Company's aggregate accounts receivable, net of the allowance for doubtfulaccounts, in total from government-owned or government-supported healthcareproviders in Greece, Ireland, Italy, Portugal and Spain (the "RelevantCountries") are as follows: December December 31, 2011 31, 2010 $'M $'M Total accounts receivable, net in 184 144the Relevant Countries Total accounts receivable, net in 22% 21%the Relevant Countries as a percentage of total outstanding accounts receivable, net Accounts receivable, net due from 170 126government-owned or government-supported healthcare providers for the Relevant Countries Accounts receivable due from government-owned or government-supportedhealthcare providers in the Relevant Countries of $170 million (2010: $126million) are split by country as follows: Greece $4 million (2010: $8 million);Ireland $1 million (2010: $1 million); Italy $81 million (2010: $60 million);Portugal $14 million (2010: $5 million) and Spain $70 million (2010: $52million).In 2011 the Company received $193 million in settlement of accounts receivablein the Relevant Countries - $11 million was from Greece (including $2.1 millionin the form of Greek Government Bonds ("GGBs")); $18 million from Ireland; $94million from Italy; $5 million from Portugal and $65 million from Spain.

To date the Company has not incurred significant losses on the accounts receivable in the Relevant Countries, and continues to consider that such accounts receivable are recoverable.

Other than the GGBs (principal amount $2.1 million, carrying value $0.7 millionas at December 31, 2011) and accounts receivable from government-owned orsupported healthcare providers outlined above, the Company does not hold anyother government debt from the Relevant Countries. Additionally the Companydoes not consider it is currently exposed to significant sovereign credit riskoutside of the Relevant Countries.The Company continues to evaluate all its accounts receivable for potentialcollection risks and has made provision for amounts where collection isconsidered to be doubtful. If the financial condition of the Relevant Countriesor other Eurozone countries suffer significant deterioration, such that theirability to make payments becomes uncertain, or if one or more Eurozone membercountries withdraws from the Euro, additional allowances for doubtful accountsmay be required, and losses may be incurred, in future periods. Any such losscould have an adverse effect on the Company's financial condition and resultsof operations.InflationAlthough at reduced levels in recent years, inflation continues to apply upwardpressure on the cost of goods and services which are used in the business.However, the Company believes that the net effect of inflation on its revenuesand operations has been minimal during the past three years.

Off-balance sheet arrangements

There are no off-balance sheet arrangements, aside from the collaborationscontaining contractual commitments and milestones which are contingent onfuture events as outlined above, that have, or are reasonably likely to have, acurrent or future material effect on the Company's financial condition,revenues or expenses, results of operations, liquidity, capital expenditures orcapital resources.

Dividends paid and dividend policy

A first interim dividend for the first half of 2011 of 2.48 US cents (1.52pence) per Ordinary Share, equivalent to 7.44 US cents per ADS, was paid inOctober 2011. The Board has resolved to pay a second interim dividend of 12.59US cents (7.96 pence) per Ordinary Share equivalent to 37.77 US cents per ADSfor the six months to December 31, 2011.This is consistent with Shire's stated policy of paying a dividendsemi-annually, set in US cents per ordinary share. Typically, the firstinterim payment each year will be higher than the previous year's first interimUSD dividend. Dividend growth for the full year will be reviewed by the Boardwhen the second interim dividend is determined.

2. Principal risks and uncertainties

The Group has adopted a risk management strategy designed to identify, assess and manage the significant risks that it faces. While the Group aims to identify and manage such risks, no risk management strategy can provide absolute assurance against loss.

Mitigation of principal risks

The management and mitigation of risks are a key focus for the Group. The Grouphas established The Risk Council which is supported by the Global Complianceand Risk Management ("GCRM") Department to oversee the management andmitigation of the principal risks faced by the Group, as set out below.

Risk Council

The Risk Council comprises a number of senior executives, from functions acrossthe Group, and is charged with overseeing the risk management process andactivities of the Group. Chaired by the Chief Compliance and Risk Officer, theRisk Council's membership includes senior members of each of the Groupbusinesses, in addition to the Head of Internal Audit. Each business unit andcorporate function is required to periodically review the significant risksfacing their businesses, and are provided with a framework for use in theirreview. This review includes identifying operational risks, compliance risksand risks to the achievement of goals and objectives. That review occurs twiceannually and material risks are recorded on a corporate risk schedule forreview and assessment of the risks and associated mitigation plans. The RiskCouncil identifies a manager who is given responsibility for the management ofany given risk.

The risk schedule is reviewed and validated by the Leadership Team. In addition, the risk schedule is reviewed twice yearly by the Audit Compliance & Risk ("ACR") Committee, and on an annual basis by the Board.

GCRM

The Risk Council is assisted by the GCRM Department, which is responsible for supporting the development and implementation of practices that facilitate employees' compliance with laws and Group policy. The department provides assistance to help employees meet high ethical standards and comply with applicable laws and regulations.

The principal focus of Shire's compliance effort is to prevent and detectmisconduct or non-compliance with laws or regulations through the promotion ofethical behavior, policy development, appropriate training, monitoring andaudit. Shire employees are encouraged to seek help and to report suspectedcases of misconduct without fear of retaliation. Employees can report suspectedcases of misconduct to management or through the confidential reporting linesmanaged by GCRM. Concerns and allegations are fairly and independentlyinvestigated and appropriate disciplinary action is taken if warranted.The GCRM department is managed by the Chief Compliance and Risk Officer, whoreports directly to the CEO. The Chief Compliance and Risk Officer chairs theRisk Council and regularly provides summary reports on the Risk Council andCompliance activities to the Audit Compliance and Risk Committee. The ChiefCompliance and Risk Officer has access at all times to the ACR Committee chairwhich provides a mechanism for bypassing the executive management should theneed ever arise.Set out below are the key risk factors associated with the business, that havebeen identified through the Group's approach to risk management. Some of theserisk factors are specific to the Group, and others are more generallyapplicable to the pharmaceutical industry in which the Group operates. TheGroup considers that these risk factors apply equally and therefore all shouldbe carefully considered before any investment is made in Shire.

RISK FACTORS RELATED TO THE COMPANY'S BUSINESS

The Company's products may not be a commercial success

The commercial success of the Company's marketed products and other newproducts that the Company may launch in the future, will depend on theirapproval and acceptance by physicians, patients and other key decision-makers,as well as the timing of the receipt of additional marketing approvals, thescope of marketing approvals as reflected in the product's label, the countriesin which such approvals are obtained, the authorization of price andreimbursement in those countries where price and reimbursement is negotiated,and safety, efficacy, convenience and cost-effectiveness of the product ascompared to competitive products.

The Company may not be able to grow its product revenues as quickly as anticipated if any or all of the following occur:

* if Shire's products or competitive products are genericized or if the

prices of competitor products are otherwise reduced significantly;

* if there are unanticipated adverse events experienced with the Company's

products or those of a competitor's product in the same therapeutic area

not seen in clinical trials that impact the physician's willingness to prescribe the Company's products; * if issues arise from clinical trials being conducted for post marketing

purposes or for registration in another country or if regulatory agencies

in one country act in a way that raises concerns for regulatory agencies or

for prescribers or patients in another country;

* if patients, payors or physicians favor other treatments over the Company's

products;

* if government regulation is stricter for the Company's products than for

other treatments; * loss of patent protection or ability of competitors to challenge or circumvent patents;

* if planned geographical expansion into emerging markets is not successful;

* if the sizes of the patient populations for the Company's products are less

than expected or the Company fails to identify new patients for its

products; or

* if there are lawsuits filed against Shire, including but not limited to,

product liability claims, consumer law claims, and payor or reimbursement

litigation.

If the Company is unable to commercialize any of its products successfully, there may be a material adverse effect on the Company's revenues, financial condition and results of operations.

Unanticipated decreases in revenues from ADDERALL XR could significantly reduce the Company's revenues and earnings

Following the launch of authorized generic versions of ADDERALL XR in 2009,Shire's sales of ADDERALL XR decreased by 42% in 2010 compared to 2009. In theyear to December 31, 2011 product sales of ADDERALL XR increased 48% to $532.8million, representing approximately 12% of the Company's total revenues, (salesof ADDERALL XR in the years to December 31, 2010 and 2009 were $360.8 millionand $626.5 million respectively).

The Company sells authorized generic versions of ADDERALL XR to Teva and Impax and currently receives royalties from Impax in respect of sales of its authorized generic. Shire continues to sell the branded version of ADDERALL XR.

Factors that could negatively impact total revenue from ADDERALL XR include, but are not limited to:

* erosion of ADDERALL XR product sales if the authorized generic versions

capture Shire's branded market share;

* any approval by the FDA of any ANDAs for ADDERALL XR which could further

reduce branded market share. Any such approval may eliminate or reduce

royalties currently received from Impax;

* issues impacting the production of ADDERALL XR or the supply of amphetamine

salts including, but not limited to, the ability to get sufficient quota

from the US DEA; * changes in reimbursement policies of third party payors; and * changes to the level of sales deductions for ADDERALL XR for private or public payors. In addition, in respect of the period prior to October 1, 2010, when certainprovisions of the 2010 Affordable Care Act became effective and providedfurther clarity, there were potentially different interpretations as to howshipments of authorized generic ADDERALL XR to Teva and Impax should beincluded in the Medicaid rebate calculation. The CMS may disagree with theCompany's interpretation as to how shipments of authorized generic ADDERALL XRshould be included in the Medicaid rebate calculation, and require the Companyto apply an alternative interpretation of the Medicaid rebate legislation,resulting in additional liability to be recorded by the Company.

The failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third party payors in a timely manner for the Company's products may impact future revenues and earnings

The Company's revenues are partly dependent on the level of reimbursementprovided to the Company by governmental reimbursement schemes for its products.Changes to governmental policy or practices could adversely affect theCompany's revenues, financial condition and results of operations. In addition,the reimbursement of treatments by healthcare providers, private healthinsurers and other organizations, such as health maintenance organizations andmanaged care organizations is under downward pressure and this, in turn, couldimpact on the prices at which the Company can sell its products.The market for the Company's products could be significantly influenced by thefollowing, which could result in lower prices for the Company's products and/ora reduced demand for the Company's products:

* higher levels of controls on the use of the Company's products and/or

requirements for additional price concessions by managed healthcare

organizations;

* legislative proposals to reform healthcare and government insurance

programs in many of the Company's markets; and

* price controls and non-reimbursement of new and highly priced medicines for

which the economic and therapeutic rationales are not established.

The prices for certain of the Company's products, in particular products forthe treatment of rare genetic diseases such as REPLAGAL, ELAPRASE and VPRIV,may be high, compared to other pharmaceutical products. The Company mayencounter difficulty in obtaining satisfactory pricing and reimbursement forsuch products. The failure to obtain and maintain pricing and reimbursement atsatisfactory levels for such products may adversely affect the Company'srevenues, financial condition and results of operations.

A disruption to a product's supply chain may result in the Company being unable to continue marketing or developing a product, or may result in the Company being unable to do so on a commercially viable basis

The Company sources some products from third party contract manufacturers, andfor certain products has its own manufacturing capability. Although the Companydual-sources certain key products and/or active ingredients. The Companycurrently relies on a single source for production of the final drug productfor each of ADDERALL XR, FIRAZYR, FOSRENOL, INTUNIV, PENTASA, RESOLOR andVPRIV, relies on a single active ingredient source for each of ELAPRASE,FIRAZYR, FOSRENOL, INTUNIV, REPLAGAL, RESOLOR and VPRIV and relies on a singlesource for certain serum reagents, the mesh framework and the manifold used inthe manufacture of DERMAGRAFT.

In the event of:

* financial failure of a third party contract manufacturer; or

* the failure of a third party manufacturer to comply with its contractual

obligations; or

* the failure of the Company or a third party contract manufacturer to comply

with mandatory manufacturing standards ("Current Good Manufacturing Standards" or "cGMP"); or * the failure of the Company or a third party contract manufacturer to manufacture sufficient quantities of product to meet demand; or * any other form of disruption to the supply chain

the Company may experience a delay in supply or be unable to supply, market ordevelop its products. Any disruption in the supply chain could have a materialadverse effect on the Company's revenues, financial condition and results ofoperations.There is no assurance that suppliers will continue to supply on commerciallyviable terms, or be able to supply components that meet regulatoryrequirements. The Company is also subject to the risk that suppliers will notbe able to meet the quantities needed to meet market requirements, which mayresult in the shortage of product supplies in the marketThe development and approval of the Company's products depends on the abilityto procure active ingredients and special packaging materials from sourcesapproved by regulatory authorities. As the marketing approval process requiresmanufacturers to specify their own proposed suppliers of active ingredients andspecial packaging materials in their applications, regulatory approval of a newsupplier would be required if active ingredients or such packaging materialswere no longer available from the supplier specified in the marketing approval.The need to qualify a new supplier could delay the Company's development andcommercialization efforts.The Company uses bovine-derived serum sourced from New Zealand and NorthAmerica in the manufacturing process for ELAPRASE and DERMAGRAFT. The discoveryof additional cattle in North America or the discovery of cattle in New Zealandwith bovine spongiform encephalopathy, or mad cow disease, could cause theregulatory agencies in some countries to impose restrictions on these products,or prohibit the Company from using them. This could disrupt the Company'sability to supply these products and would have a material adverse effect onthe Company's revenues, financial conditions or results of operations.

The actions of certain customers can affect the Company's ability to sell or market products profitably, as well as impact net sales and growth comparisons

A small number of large wholesale distributors control a significant share ofthe US and certain European markets. In 2011, for example, 49% of the Company'sproduct sales were attributable to three customers in the US: McKesson Corp.,Cardinal Health, Inc and AmerisourceBergen Corp. In the event of financialfailure of either of these customers, the Company may suffer financial loss anda decline in revenues and earnings. In addition, the number of independent drugstores and small chains has decreased as retail pharmacy consolidation hasoccurred. Consolidation or financial difficulties could cause customers toreduce their inventory levels, or otherwise reduce purchases of the Company'sproducts. Such actions could have an adverse effect on the Company's revenues,financial condition and results of operations. A significant portion of theCompany's SP product sales are made to major pharmaceutical wholesaledistributors as well as to large pharmacies in both the US and Europe.Consequently, product sales and growth comparisons may be affected byfluctuations in the buying patterns of major distributors and other tradebuyers. These fluctuations may result from seasonality, pricing, wholesalerbuying decisions, or other factors. In addition, a significant portion of theCompany's revenues for certain products for treatment of rare genetic diseasesare concentrated with a small number of customers. Changes in the buyingpatterns of those customers may have an adverse effect on the Company'srevenues, financial condition and results of operations.Investigations or enforcement action by regulatory authorities or lawenforcement agencies relating to the Company's activities in the highlyregulated markets in which it operates may result in the distraction of seniormanagement, significant legal costs and the payment of substantial compensationor finesThe Company engages in various marketing, promotional and educationalactivities pertaining to, as well as the sale of, pharmaceutical products in anumber of jurisdictions around the world. The promotion, marketing and sale ofpharmaceutical products is highly regulated and the operations of marketparticipants, such as the Company, are closely supervised by regulatoryauthorities and law enforcement agencies, including the US Department of Healthand Human Services ("HHS"), the FDA, the US Department of Justice, the SEC andthe DEA. These authorities and agencies have broad authority to investigatemarket participants for violations of federal laws relating to the marketingand promotion of pharmaceutical products, including the False Claims Act, theAnti-Kickback Statute and the Foreign Corrupt Practices Act, among others, foralleged improper conduct, including corrupt payments to government officials,improper payments to medical professionals, off-label marketing ofpharmaceutical products, and the submission of false claims for reimbursementby the federal government. Pharmaceutical companies may be subject toenforcement actions or prosecution for such conduct, as well. Any inquiries orinvestigations into the operations of, or enforcement or other regulatoryaction against, the Company by such authorities could result in the distractionof senior management for prolonged periods of time, significant defence costs,substantial monetary penalties and require extensive government monitoring ofCompany activities in the future. As an example, on September 23, 2009 theCompany received a subpoena from the HHS Office of Inspector General incoordination with the US Attorney for the Eastern District of Pennsylvania,seeking production of documents related to the sales and marketing of ADDERALLXR, VYVANSE and DAYTRANA. Shire is co-operating and responding to thissubpoena.

Adverse outcomes in legal matters could have a material adverse effect on our revenue, financial condition and results of operations.

During the ordinary course of its business the Company may be involved inclaims, disputes and litigation with third parties, employees, regulatoryagencies, governmental authorities and other parties. The range of matters ofa legal nature that might arise is extremely broad but could include, withoutlimitation, employment claims and disputes, intellectual property claims anddisputes, contract claims and disputes, product liability claims and disputes,regulatory litigation and tax audits.Any unfavourable outcome in such matters could adversely impact the Company'sability to develop and commercialize its products, distract senior managementto the detriment of the business, adversely affect the profitability ofexisting products, possibly subject the Company to substantial fines, penaltiesand injunctive or administrative remedies, and possibly result in theimposition of regulatory controls or exclusion of certain products or theCompany from government reimbursement programs. Any such outcomes could have amaterial adverse effect on our revenue, financial condition and results ofoperations.Contractual relationships can create a significant dependency on third parties,the failure of whom can affect the ability to operate the Company's businessand to develop and market productsThe Company has entered into many agreements with third parties for theprovision of goods and services to enable it to operate its business. If thethird party does not provide the goods or services on the agreed basis, theCompany may not be able to continue the development or commercialization of itsproducts as planned or on a commercial basis. Additionally, it may not be ableto establish or maintain good relationships with the suppliers.The Company has entered into licensing, co-development and other agreementswith third parties. These contractual agreements may be altered, terminated orexpire and the Company may not be able to renew, extend or contract on similarcommercial terms, with the party or another third party. In such circumstances,the Company may be unable to continue to develop or market its products asplanned and could be required to abandon or divest a product line.

RISK FACTORS RELATED TO THE PHARMACEUTICAL AND BIOTECHNOLOGY INDUSTRIES IN GENERAL

The actions of governments, industry regulators and the economic environmentsin which the Company operates may adversely affect its ability to develop andprofitably market its productsChanges to laws or regulations impacting the pharmaceutical industry, in anycountry in which the Company conducts its business, may adversely impact theCompany's revenues, financial condition and results of operations. For example,changes to the regulations relating to orphan drug status may affect theexclusivity granted to products with such designation.

A slowdown of global economic growth, or continued instability of the Eurozone, could have negative consequences for our business and increase the risk of non-payment by the Company's customers

Growth of the global pharmaceutical market has become increasingly tied toglobal economic growth. Accordingly a substantial and lasting slowdown of theglobal economy or major national economies could negatively affect growth inthe markets in which the Company operates. Such a slowdown, or any resultantausterity measures adopted by governments in response to a slowdown, could alsoreduce the level of reimbursement that governments are willing and able toprovide to the Company for its products and, as a result, adversely affect theCompany's revenues, financial condition and results of operations.Any slowing economic environment may also lead to financial difficulties forsome of the Company's significant customers. In such situations, the Companycould experience delays in payment or non-payment of amounts owed which mayresult in a rising level of contractual defaults by its contractualcounterparties. The Company does business, both directly (with governmenthospitals, clinics, pharmacies and other agencies) and indirectly (throughwholesalers and distributors), with a number of Eurozone governments (includingthe governments of Greece, Ireland, Italy, Portugal and Spain) that haveexperienced or may continue to experience declines in their creditworthinesswhich may result in the continuation of significant cuts to public spending inan attempt to manage their budget deficits.In addition, there are concerns for the overall stability and suitability ofthe Euro as a single currency, given the economic and political challengesfacing individual Eurozone countries. Continuing deterioration in thecreditworthiness of Eurozone countries, the withdrawal of one or more membercountries from the EU, or the failure of the Euro as a common European currencycould adversely effect the Company's revenues, financial condition or resultsof operations.The introduction of new products by competitors may impact future revenuesThe markets in which the Company operates are highly competitive. Many of theCompany's competitors are large, well-known pharmaceutical, biotechnology,chemical and healthcare companies with considerable resources. Companies withmore resources and larger R&D expenditures have a greater ability to fundclinical trials and other development work necessary for regulatoryapplications. They may also be more successful than the Company in acquiring orlicensing new products for development and commercialization. If any productthat competes with one of the Company's principal drugs is approved, theCompany's sales of that drug could be negatively impacted.The pharmaceutical, biotechnology and regenerative medicine industries are alsocharacterized by continuous product development and technological change. TheCompany's products could, therefore, be rendered obsolete or uneconomic,through the development of new products, technological advances inmanufacturing or production by its competitors.

The successful development of products is highly uncertain and requires significant expenditures and time

Products that appear promising in research or development may be delayed or fail to reach later stages of development or the market for several reasons, including:

* preclinical or clinical tests may show the product to lack safety or efficacy; * delays may be caused by slow enrollment in clinical studies; regulatory

requirements for clinical trial drug supplies; extended length of time to

achieve study endpoints; additional time requirements for data analysis or

dossier preparation; time required for discussions with regulatory

agencies, including regulatory agency requests for additional preclinical

or clinical data; delays at regulatory agencies due to staffing or resource

limitations; analysis of or changes to study design; unexpected safety,

efficacy, or manufacturing issues; delays may arise from shared control

with collaborative partners in the planning and execution of the product

development, scaling of the manufacturing process, or getting approval for

manufacturing;

* manufacturing issues, pricing or reimbursement issues, or other factors may

render the product economically unviable; * the proprietary rights of others and their competing products and technologies may prevent the product from being developed or commercialized; and * failure to receive necessary regulatory approvals. Success in preclinical and early clinical trials does not ensure thatlarge-scale clinical trials will be successful. Clinical results are frequentlysusceptible to varying interpretations that may delay, limit, or preventregulatory approvals. The length of time necessary to complete clinical trialsand to submit an application for marketing approval for a final decision by aregulatory authority varies significantly and may be difficult to predict. Ifthe Company's large-scale or late-stage clinical trials for a product are notsuccessful, the Company will not recover its substantial investments in thatproduct.In addition, even if the products receive regulatory approval, they remainsubject to ongoing regulatory requirements, including, for example, obligationsto conduct additional clinical trials or other non-clinical testing, changes tothe product label (which could impact its marketability and prospects forcommercial success), new or revised requirements for manufacturing, writtennotifications to physicians, or product recalls or withdrawals. Further, anumber of the Company's ADHD products contain controlled substances and aresubject to regulation by the US DEA and equivalent agencies in other countries.

The failure of a strategic partner to develop and commercialize products could result in delays in approval or loss of revenue

The Company enters into strategic partnerships with other companies in areassuch as product development and sales and marketing. In these partnerships, theCompany is sometimes dependent on its partner to deliver results. While thesepartnerships are governed by contracts, the Company may not exercise directcontrol. If a partner fails to perform or experiences financial difficulties,the Company may suffer a delay in the development, a delay in the approval or areduction in sales or royalties of a product.

The failure to secure new products or compounds for development, either through in-licensing, acquisition or internal research and development efforts, may have an adverse impact on the Company's future results

The Company's future results will depend, to a significant extent, upon itsability to in-license, acquire or develop new products or compounds. TheCompany also expends significant resources on research and development. Thefailure to in-license or acquire new products or compounds, on a commerciallyviable basis, could have a material adverse effect on the Company's revenues,financial condition and results of operations. The failure of these efforts todevelop products appropriate for testing in human clinical trials could have amaterial adverse effect on the Company's revenues, financial condition andresults of operations.

The Company may fail to obtain, maintain, enforce or defend the intellectual property rights required to conduct its business

The Company's success depends upon its ability and the ability of its partnersand licensors to protect their intellectual property rights. Where possible,the Company's strategy is to register intellectual property rights, such aspatents and trademarks. The Company also relies variously on trade secrets,unpatented know-how and technological innovations and contractual arrangementswith third parties to maintain its competitive position.Patents and patent applications covering a number of the technologies andprocesses owned or licensed to the Company have been granted, or are pending invarious countries, including the US, Canada, major European countries andJapan. The Company intends to enforce vigorously its patent rights and believesthat its partners intend to enforce vigorously patent rights they have licensedto the Company. However, patent rights may not prevent other entities fromdeveloping, using or commercializing products that are similar or functionallyequivalent to the Company's products or technologies. The Company's patentrights may be successfully challenged in the future or laws providing suchrights may be changed or withdrawn. The Company cannot assure investors thatits patents and patent applications or those of its commercial partners,licensors and third party manufacturers will provide valid patent protectionsufficiently broad to protect the Company's products and technology or thatsuch patents will not be challenged, revoked, invalidated, infringed orcircumvented by third parties. In the regular course of business, the Companyis party to litigation or other proceedings relating to intellectual propertyrights.Additionally, the Company's products, or the technologies or processes used toformulate or manufacture those products may now, or in the future, infringe thepatent rights of third parties. It is also possible that third parties willobtain patent or other proprietary rights that might be necessary or useful forthe development, manufacture or sale of the Company's products. If thirdparties are the first to invent a particular product or technology, it ispossible that those parties will obtain patent rights that will be sufficientlybroad to prevent the Company or its strategic partners from developing,manufacturing or selling its products. The Company may need to obtain licensesfor intellectual property rights from others to develop, manufacture and marketcommercially viable products and may not be able to obtain these licenses oncommercially reasonable terms, if at all. In addition, any licensed patents orproprietary rights may not be valid and enforceable.The Company also relies on trade secrets and other unpatented proprietaryinformation, which it generally seeks to protect by confidentiality andnon-disclosure agreements with its employees, consultants, advisors andpartners. These agreements may not effectively prevent disclosure ofconfidential information and may not provide the Company with an adequateremedy in the event of unauthorized disclosure of such information. If theCompany's employees, scientific consultants or partners develop inventions orprocesses that may be applicable to the Company's products under development,such inventions and processes will not necessarily become the Company'sproperty, but may remain the property of those persons or their employers.Protracted and costly litigation could be necessary to enforce and determinethe scope of the Company's proprietary rights. The failure to obtain ormaintain patent and trade secret protection, for any reason, could allow othercompanies to make competing products which could have a material adverse effecton the Company's revenues, financial condition or results of operations.The Company has filed applications to register various trademarks for use inconnection with its products in various countries including the US andcountries in Europe and Latin America and intends to trademark new productnames as new products are developed. In addition, with respect to certainproducts, the Company relies on the trademarks of third parties. Thesetrademarks may not afford adequate protection or the Company or the thirdparties may not have the financial resources to enforce any rights under any ofthese trademarks. The Company's inability or the inability of these thirdparties to protect their trademarks because of successful third party claims tothose trademarks could allow others to use the Company's trademarks and dilutetheir value.If a marketed product fails to work effectively or causes adverse side effects,this could result in damage to the Company's reputation, the withdrawal of theproduct and legal action against the CompanyUnanticipated side effects or unfavorable publicity from complaints concerningany of the Company's products, or those of its competitors, could have anadverse effect on the Company's ability to obtain or maintain regulatoryapprovals or successfully market its products. The testing, manufacturing,marketing and sales of pharmaceutical products entails a risk of productliability claims, product recalls, litigation and associated adverse publicity.The cost of defending against such claims is expensive even when the claims arenot merited. A successful product liability claim against the Company couldrequire the Company to pay a substantial monetary award. If, in the absence ofadequate insurance coverage, the Company does not have sufficient financialresources to satisfy a liability resulting from such a claim or to fund thelegal defense of such a claim, it could become insolvent. Product liabilityinsurance coverage is expensive, difficult to obtain and may not be availablein the future on acceptable terms. Although the Company carries productliability insurance when available, this coverage may not be adequate. Inaddition, it cannot be certain that insurance coverage for present or futureproducts will be available. Moreover, an adverse judgment in a productliability suit, even if insured or eventually overturned on appeal, couldgenerate substantial negative publicity about the Company's products andbusiness and inhibit or prevent commercialization of other products.

Loss of highly qualified management and scientific personnel could cause the Company subsequent financial loss

The Company faces competition for highly qualified management and scientificpersonnel from other companies, academic institutions, government entities andother organizations. It may not be able to successfully attract and retain suchpersonnel. The Company has agreements with a number of its key scientific andmanagement personnel for periods of one year or less. The loss of suchpersonnel, or the inability to attract and retain the additional, highlyskilled employees required for its activities could have an adverse effect onthe Company's business.

3. Directors' responsibility statement

Each of the current Directors, whose names and functions are listed below, confirms that, to the best of his or her knowledge:

i. the Group financial statements, which have been prepared under accounting

principles generally accepted in the United States (`US GAAP'), present

fairly, in all material respects, the financial condition, results of

operations and cash flows of the Group; and

ii. the Business review includes a fair review of the development and

performance of the business and the position of the Group and the

undertakings included in the consolidation taken as a whole, together with

a description of the principal risks and uncertainties they face.

Matthew Emmens - Chairman

Angus Russell - Chief Executive Officer

Graham Hetherington - Chief Financial Officer

David Kappler - Non-Executive Director

William Burns - Non-Executive Director

Dr David Ginsburg - Non-Executive Director

Anne Minto OBE - Non-Executive Director

Susan Kilby - Non-Executive Director

David Stout - Non-Executive Director

The following are trademarks either owned or licensed by Shire plc or companieswithin the Shire which are the subject of trademark registrations in certainterritories, or which are owned by third parties as indicated and referred toin this document:ADDERALL XR® (mixed salts of a single entity amphetamine)AGRYLIN® (anagrelide hydrochloride)APLIGRAF® (trademark of Organogenesis, Inc. ("Organogenesis"))APRISO® (trademark of Salix Pharmaceuticals, Ltd. ("Salix"))ASACOL® (trademark of Medeva Pharma Suisse AG (used under license by WarnerChilcott Company, LLC ("Warner Chilcott")))ATRIPLA® (trademark of Bristol Myers Squibb Company ("BMS") and GileadSciences, 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"))DERMAGRAFT® (Human Fibroblast-Derived Dermal Substitute)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® (methylphenidate hydrochloride)EQUASYM XL® (methylphenidate hydrochloride)FIRAZYR® (icatibant)FOSRENOL® (lanthanum carbonate)FABRAZYME® (trademark of Genzyme)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® (trademark of Giuliani International Limited ("Guiliani"))MEDIKINET® (trademark of Medice Arzneimittel P¼tter GmbH & Co. KG ("Medice"))METAZYMâ„¢ (arylsulfatase-A)METADATE CD® (trademark of UCB Pharma, S.A.)MEZAVANT® (trademark of Guiliani)MICROTROL® (trademark of Supernus Pharmaceuticals, Inc. ("Supernus"))MOVICOL® (trademark of Edra AG, S.A.)PENTASA® (trademark of Ferring B.V. Corp ("Ferring"))REMINYL® (galantamine hydrobromide) (United Kingdom ("UK") and Republic ofIreland) (trademark of J&J, excluding UK and Republic of Ireland)REMINYL XLâ„¢ (galantamine hydrobromide) (UK and Republic of Ireland) (trademarkof 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.)SALOFALK® (trademark of Dr Falk Pharma)SEASONIQUE® (trademark of Barr Laboratories, Inc. ("Barr"))STRATTERA® (trademark of Eli Lilly)TRIZIVIR® (trademark of GSK)TRUVADA® (trademark of Gilead)VENVANSE (lisdexamfetamine dimesylate)VPRIV® (velaglucerase alfa)VYVANSE® (lisdexamfetamine dimesylate)XAGRID® (anagrelide hydrochloride)ZAVESCA® (trademark of Actelion Pharmaceuticals, Ltd.)ZEFFIX® (trademark of GSK)3TC® (trademark of GSK) Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PXPress Release www.shire.com

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