=Shire (SHPG) reported earnings on Thur 16 Feb 2017 (b/o)

Shire plc beats by $0.14, beats on revs; guides FY17; XIIDRA captures 19% market share  :

• Reports Q4 (Dec) earnings of $3.37 per share, excluding non-recurring items, $0.14 better than the Capital IQ Consensus of $3.23; revenues rose 121.8% year/year to $3.81 bln vs the $3.76 bln Capital IQ Consensus.
• "In August we launched XIIDRA in the U.S. with an exceptional new drug launch, demonstrating our strength in commercial excellence and capturing 19% of market share within four months."
• Co issues guidance for FY17, sees EPS of $14.60-15.20, excluding non-recurring items, vs. $15.26 Capital IQ Consensus Estimate; sees FY17 revs of $14.5-14.8 bln in product sales, $600-700 mln in royalties & other revenues vs. $15.32 bln Capital IQ Consensus Estimate; expects depreciation expense to be $400 - $450 million and capital expenditure to be approximately $1 billion in 2017 reflecting the co's larger footprint and important investments to support growth aspirations.
• Dividend: In respect of the six months ended December 31, 2016, the Board resolved to pay an interim dividend of 25.70 U.S. cents per Ordinary Share (2015: 22.16 U.S. cents per Ordinary Share).
• Recent Developments:
  • CUVITRU for the treatment of primary immunodeficiency disorders: Global expansion is ongoing. CUVITRU was launched in Switzerland in January 2017. Shire expects to initiate further launches and additional global regulatory submissions for CUVITRU in 2017.
  • ONIVYDE for the treatment of pancreatic cancer: ONIVYDE was launched in Germany and Austria during Q4 2016. This follows the October 18, 2016 announcement that the European Commission had approved ONIVYDE (pegylated liposomal irinotecan hydrochloride trihydrate) for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (:LV), in adult patients who have progressed following gemcitabine-based therapy. Additional launches are planned in 2017.
  • NATPAR for the treatment of hypoparathyroidism: The CE Mark for the NATPAR auto-injector device was granted and submitted to the Committee for Medicinal Products for Human Use in January 2017. This completes the European Union (EU) submission. A decision on EU approval is anticipated in Q2 2017.
  • On December 6, 2016, Shire received planning permission for its new state-of-the-art biologics manufacturing facility in Piercetown, County Meath, Ireland.