PSDV » Topics » Research and Development

These excerpts taken from the PSDV 10-Q filed May 13, 2009.

Research and Development

Research and development decreased by approximately 1.7 million, or 48%, to approximately $1.9 million for the three months ended March 31, 2009 from approximately $3.6 million for the three months ended March 31, 2008. This decrease was primarily attributable to (i) the absence of $1.2 million of Iluvien co-development costs incurred in the prior year period as a result of the assumption by Alimera of all financial responsibility for the development of licensed products under the amended collaboration agreement and (ii) a decrease of approximately $651,000 of UK-based research and development costs, of which approximately $380,000 was attributable to the relative strengthening of the dollar to the Pound Sterling currency and approximately $270,000 was primarily attributable to reductions of clinical trial, legal and facilities costs. As a result of the amended Alimera agreement, the Company does not expect to incur future costs for the development of Iluvien. On a constant currency basis, we currently expect research and development expense for the fourth quarter of fiscal 2009 to change by less than 10% compared to the current quarterly period.

Research and Development

Research and development decreased by approximately $5.8 million, or 49%, to approximately $6.2 million for the nine months ended March 31, 2009 from approximately $12.0 million for the nine months ended March 31, 2008. This decrease was primarily attributable to (i) the absence of $4.7 million of Iluvien co-development costs incurred in the prior year period as a result of the assumption by Alimera of all financial responsibility for the development of licensed products under the amended collaboration agreement and (ii) a decrease of approximately $1.1 million of UK-based research and development costs, of which approximately $850,000 was attributable to the relative strengthening of the dollar to the Pound Sterling currency and approximately $280,000 was primarily attributable to reductions of personnel, legal and facilities costs.

 

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These excerpts taken from the PSDV 10-Q filed Feb 11, 2009.

Research and Development

Research and development decreased by approximately $2.9 million, or 58%, to approximately $2.1 million for the three months ended December 31, 2008 from approximately $4.9 million for the three months ended December 31, 2007. This decrease was primarily attributable to (i) the absence of $2.5 million of Iluvien co-development costs incurred in the prior year period as a result of the assumption by Alimera of all financial responsibility for the development of licensed products under the amended collaboration agreement and (ii) a decrease of approximately $300,000 of UK-based research and development costs attributable to the relative strengthening of the dollar to the Pound Sterling currency. As a result of the amended Alimera agreement, the Company does not expect to incur future costs for the development of Iluvien. Assuming that average exchange rates remain substantially equivalent to the current period rate, we currently expect research and development expense for the remaining quarters of fiscal 2009 to increase by less than 10% compared to the current quarterly period.

Research and Development

Research and development decreased by approximately $4.1 million, or 49%, to approximately $4.3 million for the six months ended December 31, 2008 from approximately $8.4 million for the six months ended December 31, 2007. This decrease was primarily attributable to (i) the absence of $3.6 million of Iluvien co-development costs incurred in the prior year period as a result of the assumption by Alimera of all financial responsibility for the development of licensed products under the amended collaboration agreement and (ii) a decrease of approximately $480,000 of UK-based research and development costs attributable entirely to the relative strengthening of the dollar to the Pound Sterling currency.

 

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This excerpt taken from the PSDV 10-Q filed Nov 12, 2008.

Research and Development

Research and development decreased by approximately $1.2 million, or 36%, to approximately $2.2 million for the three months ended September 30, 2008 from approximately $3.5 million for the three months ended September 30, 2007. This decrease was primarily attributable to the assumption by Alimera of all financial responsibility for the development of licensed products under the amended collaboration agreement. As a result of this amendment, the Company does not expect to incur future costs for the development of Iluvien.

These excerpts taken from the PSDV 10-K filed Sep 26, 2008.

Research and Development

Research and development costs are recognized as an expense in the period in which they are incurred. Research and development costs include wages, benefits and other operational costs related to the Company’s research and development departments, clinical trial activities and supplies and amortization of intangible assets. The fair value of acquired in-process research and development costs is expensed as of the acquisition date if the related projects have not reached technological feasibility and are determined to have no alternative future use.

Research and Development

FACE="Times New Roman" SIZE="2">Research and development costs are recognized as an expense in the period in which they are incurred. Research and development costs include wages, benefits and other operational costs related to the Company’s
research and development departments, clinical trial activities and supplies and amortization of intangible assets. The fair value of acquired in-process research and development costs is expensed as of the acquisition date if the related projects
have not reached technological feasibility and are determined to have no alternative future use.

This excerpt taken from the PSDV 8-K filed Jun 20, 2008.

Research and Development

Research and development costs are recognized as an expense in the period in which they are incurred. Research and development costs include wages, benefits and other operational costs related to the Company’s research and development departments, clinical trial activities and supplies and amortization of intangible assets.

This excerpt taken from the PSDV 10-Q filed Jun 18, 2008.

Research and Development

Research and development decreased by approximately $3.3 million, or 28%, to approximately $8.4 million for the six months ended December 31, 2007 from approximately $11.7 million for the six months ended December 31, 2006. This decrease was primarily attributable to the following factors:

 

   

A decrease of approximately $3.2 million in amortization of intangible assets due to the effects of (i) the $45.3 million asset impairment write-down at June 30, 2007 related to our Retisert patent and (ii) the revision of the expected useful life for our BrachySil intangible assets from 7 years to 11 years effective as of December 31, 2006; and

 

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A decrease of approximately $1.3 million in our U.K. and Singapore-based operating expenses as a result of (i) personnel cost reductions in the United Kingdom which were implemented as cost reduction measures and (ii) reduced depreciation expense related to a clean room facility that was fully depreciated at June 30, 2007; partially offset by

 

   

an increase of approximately $1.8 million for shared development costs related to the Phase III clinical trial of the Medidur FA for DME product candidate.

This excerpt taken from the PSDV 10-Q filed Jun 18, 2008.

Research and Development

Research and development decreased by approximately $4.9 million, or 29%, to approximately $12.0 million for the nine months ended March 31, 2008 from approximately $16.9 million for the nine months ended March 31, 2007. This decrease was primarily attributable to the following factors:

 

   

a decrease of approximately $4.3 million in amortization of intangible assets due to the effects of (i) the $45.3 million asset impairment write-down at June 30, 2007 related to our Retisert patents and (ii) the revision of the expected useful life for our BrachySil intangible assets from 7 years to 11 years effective as of December 31, 2006; and

 

   

a decrease of approximately $1.9 million in our U.K. and Singapore-based operating expenses as a result of (i) personnel reductions in the U.K. which were implemented as cost reduction measures and (ii) reduced depreciation expense related to a clean room facility that was fully depreciated at June 30, 2007; which were partially offset by

 

   

an increase of approximately $2.0 million in development costs related to the Phase III clinical trial of the Medidur FA for DME product candidate.

This excerpt taken from the PSDV 10-Q filed May 12, 2008.

Research and Development

Research and development decreased by approximately $4.9 million, or 29%, to approximately $12.0 million for the nine months ended March 31, 2008 from approximately $16.9 million for the nine months ended March 31, 2007. This decrease was primarily attributable to the following factors:

 

   

a decrease of approximately $4.3 million in amortization of intangible assets due to the effects of (i) the $45.3 million asset impairment write-down at June 30, 2007 related to our Retisert patents and (ii) the revision of the expected useful life for our BrachySil intangible assets from 7 years to 11 years effective as of December 31, 2006; and

 

   

a decrease of approximately $1.9 million in our U.K. and Singapore-based operating expenses as a result of (i) personnel reductions in the U.K. which were implemented as cost reduction measures and (ii) reduced depreciation expense related to a clean room facility that was fully depreciated at June 30, 2007; which were partially offset by

 

   

an increase of approximately $2.0 million in development costs related to the Phase III clinical trial of the Medidur FA for DME product candidate.

This excerpt taken from the PSDV 10-Q filed Feb 11, 2008.

Research and Development

Research and development decreased by approximately $3.3 million, or 28%, to approximately $8.4 million for the six months ended December 31, 2007 from approximately $11.7 million for the six months ended December 31, 2006. This decrease was primarily attributable to the following factors:

 

   

A decrease of approximately $3.2 million in amortization of intangible assets due to the effects of (i) the $45.3 million asset impairment write-down at June 30, 2007 related to our Retisert patent and (ii) the revision of the expected useful life for our BrachySil intangible assets from 7 years to 11 years effective as of December 31, 2006; and

 

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A decrease of approximately $1.3 million in our U.K. and Singapore-based operating expenses as a result of (i) personnel cost reductions in the United Kingdom which were implemented as cost reduction measures and (ii) reduced depreciation expense related to a clean room facility that was fully depreciated at June 30, 2007; partially offset by

 

   

an increase of approximately $1.8 million for shared development costs related to the Phase III clinical trial of the Medidur FA for DME product candidate.

This excerpt taken from the PSDV 20-F filed Oct 1, 2007.

Research and Development

Research and development expense increased to A$26.6 million for the year ended June 30, 2006 from A$14.4 million for the year ended June 30, 2005, an increase of A$12.3 million, or 85.4%. Approximately A$4.4 million of the increase was attributable to the operations of pSivida Inc., primarily related to the Medidur for DME Phase III clinical trial in conjunction with Alimera Sciences and patent and legal costs. An additional A$3.2 million was related to amortization of the Retisert intangible asset recorded in connection with the acquisition of CDS. The remaining increase of A$4.7 million was primarily attributable to the ongoing development of our BioSilicon technology, including commencement of our Phase IIb clinical trial for lead product candidate BrachySil for the treatment of primary liver cancer, a related increase in headcount, principally at our Malvern, UK and Singapore offices to support the commencement of the trial and depreciation expense related to the completion, in September 2005, of the construction of a cleanroom facility dedicated to the final process in the manufacture of BrachySil for future clinical and commercial use.

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