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

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SHIRE PLC (Exact Name of Registrant As Specified in Its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2009 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 0-29630 SHIRE PLC (Exact name of registrant as specified in its charter) Jersey (Channel Islands) 98-0601486 (State or other jurisdiction of incorporation or (I.R.S. Employer Identification No.) organization) 5 Riverwalk, Citywest Business Campus, Dublin +353 1 429 7700 24, Republic of Ireland (Address of principal executive offices and zip code) (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of exchange on which registered American Depositary Shares, each representing three NASDAQ Global Select Market Ordinary Shares 5 pence par value per share Securities registered pursuant to Section 12(g) of the Act: None (Title of class) 1 Indicate by check mark whether the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act Yes [X] No [ ] Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act Yes [ ] No [X] Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant’s knowledge, in definitive proxy or information statements incorporated by reference to Part III of this Form 10-K or any amendment to this Form 10-K. [X] Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. Large accelerated filer [X] Accelerated filer Non-accelerated filer Smaller reporting company Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X] Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (232,405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [ ] As at June 30, 2009, the last business day of the Registrant’s most recently completed second quarter, the aggregate market value of the ordinary shares, £0.05 par value per share of the Registrant held by non-affiliates was approximately $7,709 million. This was computed using the average bid and asked price at the above date. As at February 18, 2010, the number of outstanding ordinary shares of the Registrant was 561,527,864. 2 THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission. The following are trademarks either owned or licensed by Shire plc or its subsidiaries, which are the subject of trademark registrations in certain territories, or which are owned by third parties as indicated and referred to in this Form 10-K: ADDERALL XR® (mixed salts of a single entity amphetamine) ADDERALL® (mixed salts of a single entity amphetamine) AGRYLIN® (anagrelide hydrochloride) AMIGAL® (trademark of Amicus Therapeutics, Inc. (“Amicus”)) ASACOL® (trademark of Medeva Phama Suisse AG (used under license by Proctor and Gamble)) ATRIPLA® (trademark of Bristol Myers Squibb Company (“BMS”) and Gilead Sciences (“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”)) CLAVERSAL® (trademark of Merckle Recordati) COLAZAL® (trademark of Salix Pharmaceuticals, Inc) COMBIVIR® (trademark of GlaxoSmithKline (“GSK”)) CONCERTA® (trademark of Alza Corporation (“Alza”)) DAYTRANA® (methylphenidate transdermal system) DIPENTUM® (trademark of UCB Pharma Ltd (“UCB”)) DYNEPO® (trademark of Sanofi-Aventis) ELAPRASE® (idursulfase) EPIVIR® (trademark of GSK) EPIVIR-HBV® (trademark of GSK) EPZICOM®/KIVEXA (EPZICOM) (trademark of GSK) EQUASYM® IR (methylphenidate hydrochloride) EQUASYM® XL (methylphenidate hydrochloride) FIRAZYR® (icatibant) FOSRENOL® (lanthanum carbonate) FABRAZYME® (trademark of Genzyme) FOCALIN XR® (trademark of Novartis Pharmaceuticals Corporation) FUZEON® (trademark of Roche) HEPTOVIR® (trademark of GSK) INTUNIV™ (guanfacine extended release) JUVISTA® KALETRA® (trademark of Abbott Laboratories (“Abbott”)) LIALDA® (mesalamine) METAZYM™ (arylsulfatase-A) METADATE CD® (trademark of UCB) MEZAVANT® (mesalazine) MICROTROL® (trademark of Supernus Pharmaceuticals, Inc.) PENTASA® (trademark of Ferring A/S Corp(“Ferring”)) PLICERA™ ® (trademark of Amicus) RAZADYNE® (trademark of Johnson & Johnson (“J&J”)) RAZADYNE® ER (trademark of J & J) 3 REMINYL® (galantamine hydrobromide) (United Kingdom ("UK”) and Republic of Ireland) (trademark of J & J, excluding UK and Republic of Ireland) REMINYL XL™ (galantamine hydrobromide) (UK and Republic of Ireland) (trademark of J & J, excluding UK and Republic of Ireland) REPLAGAL® (agalsidase alfa) RETROVIR® (trademark of GSK) REYATAZ® (trademark of BMS) RITALIN LA® (trademark of Novartis) SALOFALK® (trademark of Dr Falk Pharma) SEASONIQUE® (trademark of Barr Laboratories, Inc. (“Barr”)) SOLARAZE® (trademark of Laboratorios Almirall S.A (“Almirall”)) STRATTERA® (trademark of Eli Lilly) SUSTIVA® (trademark co-owned DuPont Pharmaceuticals and BMS) TRIZIVIR® (trademark of GSK) TRUVADA® (trademark of Gilead) VANIQA® (trademark of Almirall) VIDEX® (trademark of BMS) VIRAMUNE® (trademark of Boehringer-Ingelheim) VIREAD® (trademark of Gilead) VYVANSE® (lisdexamfetamine dimesylate) VPRIVTM (velaglucerase alfa) XAGRID® (anagrelide hydrochloride) ZEFFIX® (trademark of GSK) 3TC® (trademark of GSK) 4 SHIRE PLC 2009 Form 10-K Annual Report Table of contents PART I ITEM 1. BUSINESS General 6 Strategy 6 2009 highlights 6 Financial information about operating segments 6 Sales and marketing 6 Manufacturing and distribution 19 Intellectual property 20 Competition 23 Government regulation 25 Third party reimbursement 26 Corporate responsibility 27 Employees 27 Available information 27 ITEM 1A. RISK FACTORS 28 ITEM 1B. UNRESOLVED STAFF COMMENTS 34 ITEM 2. PROPERTIES 35 ITEM 3. LEGAL PROCEEDINGS 36 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS 36 PART II MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER ITEM 5. 37 MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES ITEM 6. SELECTED FINANCIAL DATA 40 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND ITEM 7. 42 RESULTS OF OPERATIONS ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 70 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 72 CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND ITEM 9. 72 FINANCIAL DISCLOSURE ITEM 9A. CONTROLS AND PROCEDURES 72 ITEM 9B. OTHER INFORMATION 72 PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 73 ITEM 11. EXECUTIVE COMPENSATION 78 SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND ITEM 12. 101 RELATED STOCKHOLDER MATTERS CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR ITEM 13. 102 INDEPENDENCE ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 102 PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 104 5 PART I ITEM 1: Business General Shire plc and its subsidiaries (collectively referred to as either “Shire” or the “Company”) is a leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire plc (formerly known as Shire Limited) was incorporated under the laws of Jersey (Channel Islands) on January 28, 2008
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