ViroPharma Provides 2008 Outlook
"We are in the midst of a period of great momentum and promise," saidMichel de Rosen, ViroPharma's Chief Executive Officer. "For example, weexpect to build on the great clinical progress we are currently experiencingin our ongoing Phase 3 program with CAMVIA(TM)(maribavir) as we move towardour goal of a 2009 NDA filing. We also continue to work diligently in ourpre-launch activities for CAMVIA to refine our plans for medical education,marketing and communications, and ensure a successful launch. We also areextremely excited about moving our unique non-toxigenic C. difficile (NTCD)program into humans during the year; we believe that this novel approach couldone day be the therapy of choice for recurrent C. difficile infection (CDI),which remains a significant medical need in CDI patients. As a reminder, wealong with Wyeth continue to work diligently to elucidate the path forward forour HCV program which we hope will reinvigorate it this year. And, of course,our strong balance sheet puts us in a position to evaluate and potentiallyexecute upon acquisitions and in-licensing opportunities. Finally, we remainconfident in our efforts to preserve safety for CDI patients and accordinglywill be investing in both medical education for CDI and promoting Vancocin todrive growth for the product; Obviously, the decision on whether to approvegeneric versions of the drug on the basis of anything less than clinicalendpoint bioequivalence studies for this serious disease ultimately rests withFDA."
"Looking back on 2007, ViroPharma saw a tremendous amount of momentumthroughout our organization, in terms of financial performance and staffingfor continued growth," commented Mr. de Rosen. "Organizationally, we launchedViroPharma Europe in the first half of 2007, and throughout the year nearlydoubled overall the size of the global team supporting the development ofCAMVIA and preparing for its commercial launch. Financially, I can confirmthat we expect Vancocin(R) sales in 2007 to be within our guidance range of$202 to $208 million, representing growth of at least 21 percent over that of2006."
Looking ahead in 2008
ViroPharma is commenting upon future guidance for the year 2008 as aconvenience to investors. The following elements of guidance provided byViroPharma are projections, based upon numerous assumptions, all of which aresubject to certain risks and uncertainties. For a discussion of the risks anduncertainties associated with these forward-looking statements, please see theDisclosure Notice below.
This press release includes non-GAAP financial information as the ourprojected combined R&D and SG&A expenses has been presented including andexcluding the effect of stock option expense resulting from the application ofSFAS 123R. We believe that presenting our R&D expense and SG&A expense in thisrelease both with and without the impact of share-based compensation willallow investors to better understand our financial results and how suchresults compare with our prior results and current guidance.
Further discussion of 2008 guidance will be provided along with the full-year 2007 financial results later in the first quarter of 2008.
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