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2008 Outlook
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 during 2008;
- VYVANSE for use in adult patients in the US in Q2 2008;
- DAYTRANA in the EU during H1 2009;
- INTUNIV in the US during H2 2009; and - FOSRENOL in the pre-dialysis Chronic Kidney Disease ("CKD") market in the US during 2009.
2008 Financial Outlook
We reaffirm the previous guidance given as part of the 2007 year-end results as follows:
We expect 2008 total revenue growth to be in the mid to high teens range. Based on existing prescription trends and the recently received approval for the adult indication, we currently expect VYVANSE sales to be at the lower end of the previously stated range of $350 to $400 million.
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 HGT businesses will result in R&D spend for 2008 in the range of $465 to $490 million;
- Existing and planned launches will require additional advertising and promotional spend resulting in Selling, General & Administration ("SG&A") costs for 2008 in the range of $1,125 to $1,165 million;
- Business expansion including new and enlarged manufacturing and research facilities for HGT, the enlargement of other facilities and the global roll out of new and upgraded IT infrastructures, will see a significant cash investment in capital projects in 2008 in the range of $320 to $350 million (2007: $110 million);
- Due to the higher capital expenditure, the depreciation charge for
2008 is expected to increase by approximately 50% compared to
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