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Shire On Track For Double Digit Full Year Earnings Growth

DUBLIN, October 25, 2012 /PRNewswire/ --

Advancing Late Stage Pipeline of new Growth Opportunities

Shire (LSE: SHP, NASDAQ: SHPG) announces results for the three months to September 30, 2012.
                                                        Reported       CER
    Financial Highlights                      Q3 2012   Growth (1)    Growth(2)
    Product sales                       $1,055 million         +4%         +6%
    Product sales excluding ADDERALL XR   $952 million        +10%        +13%
    Total revenues                      $1,100 million         +1%         +4%
    Non GAAP operating income             $325 million         -5%
    US GAAP operating income              $273 million         +7%
    Non GAAP diluted earnings per ADS            $1.36         +6%
    US GAAP diluted earnings per ADS             $1.19        +17%
    Non GAAP cash generation              $355 million        +20%
    Non GAAP free cash flow               $261 million        +90%
    US GAAP net cash provided by operating    
    activities                            $288 million        +61%

(1)    Percentages compare to equivalent 2011 period.

(2)    Percentages compare to equivalent 2011 period on a constant exchange rate ("CER") basis, which is a Non GAAP measure.

The Non GAAP financial measures included within this release are explained on page 25, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 20 - 24.

Angus Russell, Chief Executive Officer, commented:

"Shire's business is progressing well. This quarter we grew Non GAAP earnings per ADS by 6% after increasing our investment in R&D by over 20% to fund our increasingly late stage pipeline. We continue to generate strong cash flows (up 20% to over $350 million in the quarter), which will support our future growth.

"The ADHD market is one of the fastest-growing major therapeutic categories in the US and our lead product VYVANSE continues to gain share and generated strong prescription growth in the US despite the entry of additional generics in the ADHD market. We are advancing our preparations for the potential approval and launch of VYVANSE in Europe, where it will be called ELVANSE. Our rare disease business also continues to grow, with FIRAZYR performing strongly following its US launch. DERMAGRAFT product sales were impacted by the re-engineering of key areas of the Regenerative Medicine business, including an ongoing restructuring of the sales and marketing organization and the implementation of a new commercial model, all of which is expected to position the product for future sales growth. We anticipate that the run rate for DERMAGRAFT revenues will recover during 2013.

"In our advancing pipeline we have late stage studies for Lisdexamfetamine dimesylate ("LDX" - the active ingredient in VYVANSE) in major depressive disorder ongoing, we are planning to initiate our Phase 3 program for binge eating disorder around the turn of the year and following discussions with the FDA, we plan to initiate Phase 3 studies in negative symptoms of schizophrenia in the near future. We've also identified potential new indications for FIRAZYR and DERMAGRAFT. Our intrathecal trials for Hunter CNS, SanFilippo A and Metachromatic Leukodystrophy are also progressing well.

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