Repligen Reports Fourth Quarter and Fiscal Year 2008 Financial Results
Operating expenses for fiscal year 2008, excluding the $40,170,000 netgain from litigation previously reported in our second quarter as a result ofour settlement with ImClone Systems, Inc., were $23,574,000 compared to$15,900,000 in fiscal year 2007. The increase in operating expenses of$7,674,000 was primarily the result of legal expenses incurred in conjunctionwith both the ImClone Systems, Inc. and Bristol-Myers Squibb litigations,direct material expenses associated with the increase in revenue, andincreased research and development spending.
Net income for the year was $37,107,000 or $1.18 per diluted share,compared to a net loss for fiscal 2007 of $889,000 or $0.03 per diluted share.Net income includes a net gain of $40,170,000 from the litigation settlementwith ImClone during the second quarter of fiscal year 2008. Cash andmarketable securities as of March 31, 2008 were $60,589,000 compared to$22,627,000 as of March 31, 2007.
"During the past year, we have successfully advanced our product pipeline,achieved strong revenue growth and settled our outstanding litigations withImClone Systems, Inc. and Bristol-Myers Squibb, resulting in substantial newresources for the company," stated Walter C. Herlihy, President and ChiefExecutive Officer of Repligen Corporation. "Our financial resources willallow us to continue to execute on our strategy to acquire rights to patented,development stage drug candidates, advance the candidates throughproof-of-principle clinical trials and generate value through partnering orour own commercial efforts."
Total revenue for the fourth quarter of fiscal year 2008 was $3,301,000compared to $3,699,000 for the same period in fiscal year 2007, a decrease of11%. Operating expenses for the fourth quarter of fiscal year 2008 were$7,165,000 compared to $4,050,000. Net loss for the fourth quarter of fiscalyear 2008 was $3,198,000 or $0.10 per diluted share, compared to a net lossfor the fourth quarter of fiscal year 2007 of $107,000 or $0.00 per dilutedshare.
Secretin (RG1068) for Imaging of the Pancreas
In March, we initiated a Phase 3 clinical trial to evaluate the use ofRG1068, synthetic human secretin, to improve the assessment of pancreatic ductstructures by magnetic resonance imaging (MRI). The Phase 3 study is amulti-center, baseline-controlled, single dose study in which approximately250 patients will receive an unenhanced MRI followed by a secretin-enhancedMRI of the pancreas. The study is designed to assess the sensitivity andspecificity of secretin-enhanced MRI to improve the ability to detectpancreatic duct abnormalities relative to MRI alone. Detailed visualassessment of the pancreatic ducts is important in the assessment, diagnosisand treatment of diseases such as acute and chronic pancreatitis. The studyis being conducted at approximately 30 clinical sites within the United Statesand Canada. In April, the U.S. Food and Drug Administration granted FastTrack Designation to our development program. Fast Track is a processdesigned to facilitate the development and expedite the review of drugs thattreat serious diseases and fill an unmet medical need.
Uridine (RG2417) for Bipolar Disorder
Today, we announced that based on feedback from the Food and DrugAdministration (FDA) we plan to initiate a Phase 2b clinical trial of RG2417,an oral formulation of uridine in patients with bipolar disorder in the fall.This will be a multi-center,
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