Shire plc Delivers Strong 2012 Results and Reiterates Confidence in 2013  
2/14/2013 10:31:36 AM

February 14, 2013 – Shire (LSE: SHP, NASDAQ: SHPG) announces results for the year to December 31, 2012.

Angus Russell, Chief Executive Officer, commented:

“It’s been another strong year for Shire with 12% growth in product sales and 14% growth in Non GAAP earnings which have driven particularly strong cash generation. While delivering strong financial results, we continue to invest in our emerging late stage R&D pipeline.

Our ADHD portfolio is performing very well in a growing global market and we see further growth going forward. The positive opinion received from the European regulators for ELVANSE is a significant milestone and we’re now preparing for country launches in some of the largest markets in Europe. All our rare disease treatments continue to grow and we saw particularly strong performance from FIRAZYR in its first full year in the US market. We advanced our plans for developing our Regenerative Medicine business with the acquisition of VASCUGEL and the approval of DERMAGRAFT in Canada.

Our late stage R&D pipeline now holds the prospect of future growth from LDX (the active ingredient in VYVANSE) in major depressive disorder, binge eating disorder and negative symptoms of schizophrenia. Our intrathecal programs are also progressing well as we plan the next clinical trials for Hunter CNS and Sanfilippo A and continue to enrol MLD patients into the ongoing Phase 1/2 trial. A phase 2b study of SPD602, our iron chelating product, is underway and headline results are expected later this year.

We’ve completed a number of in-licensing deals and acquisitions in 2012, bringing us new technology platforms in rare diseases, hematology and a range of early stage and exciting differentiated treatments.

We’ve put in place our leadership succession plan. Dr. Flemming Ørnskov joined us at the beginning of January and is familiarising himself with the business before he assumes the role of CEO at the end of April. His considerable pharmaceutical and international experience will benefit Shire going forward. Today we announce that Sylvie Gregoire, President of our HGT business, has decided to leave Shire at the end of March, after five years. We’re grateful for her significant contributions to the growth of Shire through establishing HGT as a leader in rare diseases.

Shire is in great shape, with the current business performing well, a promising pipeline of new growth opportunities, and the strategy in place to deliver an exciting future. As we look forward to the year ahead, we expect our financial results to show further growth in line with current consensus earnings expectations for 2013(1).”