Shire plc Continued Strong Product Sales Performance in Q3: On Track to Deliver Significant 2011 Earnings Growth

DUBLIN, October 28, 2011 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces results for the three months to September 30, 2011.

 Financial Highlights Q3 2011(1) Product sales $1,018 million +28% Total revenues $1,086 million +24% Non GAAP operating income $341 million +15% US GAAP operating income $255 million +64% Non GAAP diluted earnings per ADS $1.28 +10% US GAAP diluted earnings per ADS $1.02 +96% Non GAAP cash generation $296 million +9% Non GAAP free cash flow $138 million +56% US GAAP net cash provided by operating activities $179 million +26% 

(1) Percentages compare to equivalent period in 2010.

The Non GAAP financial measures included within this release are explained on page 24, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 19 - 23.

Angus Russell, Chief Executive Officer, commented:

“Shire has delivered another strong set of quarterly results. Total product sales were up 28% to $1,018 million, with our newly acquired regenerative medicine product, DERMAGRAFT for Diabetic Foot Ulcers, contributing sales of $50 million in the quarter. We’re on track to deliver significant 2011 earnings growth.

Sales of our rare disease treatments were very strong: with VPRIV up 31% and REPLAGAL up 40% versus the same quarter in 2010. FIRAZYR, our self-administered treatment for acute attacks of Hereditary Angioedema, was approved by the FDA in August and launched just a few weeks ago; initial demand from patients has been positive. This week we have also initiated a rolling Biologics License Application for REPLAGAL in the US, designated Fast Track by the FDA.

The US ADHD market continues to grow and with a strong ‘back to school’ season, our portfolio of treatments has gained share. VYVANSE sales were up 32% and INTUNIV sales grew 50%.

The investment in our product portfolio is already delivering benefits and we believe our R&D pipeline will provide important therapies to patients around the world. In addition to initiating Phase 3 clinical trials for VYVANSE as adjunctive therapy in Major Depressive Disorder (MDD), we’re releasing highlights of exploratory data showing that cognition and executive function were improved in patients with MDD taking VYVANSE as adjunctive therapy. We’ve also released positive new clinical data related to our Phase 3 European ADHD clinical program. Overall, we’ve increased investment in our R&D programs by 21% compared to Q3 2010, and still generated good earnings growth and strong cashflows.

Over the course of the year we’ve seen market expectations for Shire’s 2011 earnings rise, with further increases in the last quarter. After these good third quarter results, and after taking account of the lower royalty income that we will be recording in future periods, we remain on track to meet these increased expectations. We anticipate that this will be another very good year for Shire as we deliver strong sales and continue our investment program for sustained future growth.”

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