Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces results for the three months to March 31, 2011.
The Non GAAP financial measures included within this release are explained on page 20 of the full release, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 17 - 19 of the full release.
Angus Russell, Chief Executive Officer, commented: "Shire delivered a strong first quarter with product sales from our diverse portfolio up 24%. Non GAAP diluted earnings per ADS increased 22% in the quarter. Sales of our ADHD treatments INTUNIV, VYVANSE and ADDERALL XR were all up and the overall ADHD market in the US showed good growth (13%). GI sales performed well in the first quarter, driven by LIALDA.
Our rare disease treatments, particularly VPRIV and REPLAGAL, continued their success around the world with strong growth and represent 30% of our total product sales.
This quarter we were granted FDA approval of INTUNIV as adjunctive therapy to stimulants for ADHD, we filed our US complete response for FIRAZYR and were granted European approval for FIRAZYR self-administration. Our new HGT manufacturing site in Massachusetts is progressing as planned and we've now filed for European approval of REPLAGAL in this facility.
The successful advancement of our pipeline is driving increased investment in research and development. Early data from exploratory clinical trials for VYVANSE in potential new uses is very encouraging, including the most recent findings in negative symptoms of schizophrenia, announced today. We have further plans for a study in binge eating disorder as well as the progression of our phase 3 program in major depressive disorder. Our Carrier Wave Guanfacine program continues to make progress. We anticipate further pipeline news this year.
We have made a strong start to 2011, which underpins our previously stated financial guidance."
About Shire plc
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.