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Shire Delivers Strong 2012 Results and Reiterates Confidence in 2013
Date:2/14/2013

sa ("EB")

  • In February 2013, Shire enrolled the first patient in its Phase 3 clinical program for EB.

OTHER DEVELOPMENTS

Legal Proceedings

Shire reaches agreement in principle with the US Government

  • On February 1, 2013 Shire announced that it had reached an agreement in principle to resolve the previously disclosed civil investigation into Shire's U.S. sales and marketing practices relating to ADDERALL XR, VYVANSE and DAYTRANA®. The agreement also addresses sales and marketing practices relating to LIALDA® and PENTASA® pursuant to a subsequent voluntary disclosure made by Shire. Shire has recorded a $57.5 million charge in Q4 2012, comprised of the agreement in principle amount, interest and costs. The agreement in principle is subject to change until this matter is finally resolved. Discussions between Shire and the US Government are ongoing to establish a final resolution to the investigation.

Settlement of litigation with Impax

  • On February 7, 2013 Shire and Impax settled all litigation relating to Shire's contract to supply Impax with authorized generic ADDERALL XR.

    Under the terms of the settlement Shire will make a one-time cash payment to Impax of $48.0 million and Shire and Impax entered into an amended supply agreement which will govern the supply of authorized generic ADDERALL XR from Shire to Impax until the end of the supply term on September 30, 2014. The cash payment has been recorded as a liability at December 31, 2012. As it represents a payment to a customer, the cash payment has been recorded in the Income Statement as a reduction in reported ADDERALL XR product sales ($42.0 million) and royalties ($6.0 million) in 2012, in accordance with US GAAP. The reduction to revenues for Q4 2012 was $8.0 million, with the balanc
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SOURCE Shire plc
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