2007 and Q4 2006 were $2.04:GBP1.00 and $1.92:GBP1.00 respectively.
(1) Non GAAP operating income, Non GAAP net income, Non GAAP diluted earnings per ordinary share and Non GAAP diluted earnings per ADS exclude intangible asset amortization charges, the accounting impact of share-based compensation and other items as described on page 8. For an explanation of why Shire's management believes that these non GAAP financial measures are useful to investors, see page 8. For a reconciliation of these non GAAP financial measures to the most directly comparable financial measures prepared in accordance with US GAAP, see pages 29-32.
R&D pipeline and new product launches in the next two years
Subject to obtaining relevant regulatory/governmental approvals, the following product launches are planned over the next two years:
- MEZAVANT in the EU and Canada during 2008;
- VYVANSE for use in adult patients in the US in Q2 2008 (PDUFA date
April 28, 2008);
- DAYTRANA in the EU during H1 2009;
- INTUNIV in the US during H2 2009; and
- FOSRENOL in the CKD market in the US during 2009.
Financial Outlook Shire's business continues to perform strongly. We expect 2008 total revenue growth to be in the mid to high teens range with VYVANSE sales between $350 to $400 million, assuming that the adult indication is launched by mid year 2008.
Costs are estimated as follows:
- Phase 3(b) and Phase 4 studies to support existing launches in the Specialty Pharmaceuticals ("Specialty") business and new product development in both the Specialty and Human Genetic Therapies ("HGT") businesses will result in Research and Development ("R&D") spend for 2008 in the range of $450 to $475 million (or $465 to $490 million including FAS123R charge);
- Existing and planned launches will require additional advertising and
promotional spend resulting in SG&A costs for 2008 in the range of $1,080
|SOURCE Shire plc|
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