Repligen Corporation (Nasdaq: RGEN) today reported results for the second quarter of fiscal year 2011, ended September 30, 2010. Total revenue for the second quarter was $7,307,000 compared to total revenue of $5,421,000 for the second quarter of fiscal year 2010, an increase of $1,886,000 or 35%. Bioprocessing product revenue for the second quarter was $4,416,000 compared to $2,742,000 for the second quarter of fiscal 2010, an increase of $1,674,000 or 61%. Royalty and research revenue for the second quarter, which consisted primarily of royalty payments from Bristol-Myers Squibb on the U.S. sales of Orencia®, was $2,891,000 compared to $2,679,000 for the same quarter in the prior year.
Operating expenses for the second quarter were $6,780,000 compared to $6,627,000 for the second quarter of fiscal year 2010. Net income for the second quarter was $623,000 or $0.02 per diluted share, compared to a net loss for the second quarter of fiscal year 2010 of $980,000 or $0.03 per diluted share. Cash, cash equivalents and marketable securities as of September 30, 2010 were $59,691,000 compared to $59,146,000 as of March 31, 2010.
"We are pleased to have achieved strong growth in our bioprocessing business for the quarter," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "We are focused on completing our Phase 3 study for pancreatic imaging and our Phase 2b study for bipolar depression, and we look forward to reporting the top-line results for both of these studies in the first quarter of 2011."
For the six-month period ended September 30, 2010, total revenue was $14,317,000 compared to $10,481,000 for the same period in fiscal year 2010. Operating expenses for the six-month period ended September 30, 2010 were $12,901,000 compared to $13,116,000 for the same period in fiscal year 2010. Net income for the six-month period ended September 30, 2010 was $1,611,000 or $0.05 per diluted share compared to a net loss of $2,086,000 or $0.07 per diluted share for the same period in fiscal year 2010.
Corporate Update
RG1068 for Imaging of the Pancreas
We are currently analyzing the radiographic images from our Phase 3 study of RG1068, synthetic human secretin. The goal of the study is to evaluate the sensitivity and specificity of RG1068 in combination with MRI to improve the detection of structural abnormalities of the pancreatic ducts relative to MRI alone. Detailed visual assessment of the pancreatic ducts is important in the evaluation of pancreatic duct abnormalities which may result in the diagnosis of diseases such as acute and chronic pancreatitis. Because RG1068-MRI elucidates both normal and abnormal anatomy, it may improve patient triage and pre-surgical planning and could aid in avoiding unnecessary procedures such as endoscopy which is associated with serious adverse events. Data from the Phase 3 study indicates that the use of RG1068-MRI to avoid unnecessary endoscopy would result in saving an average of one day of hospitalization per patient.
The analysis of the Phase 3 image data is a "re-read" which was agreed to by the Food and Drug Administration and European Medicines Agency based on the determination that the original analysis was flawed and therefore inconclusive due to deficiencies in performance by the contract research organization overseeing the analysis. We have selected a new contract research organization, and they are currently building the database for the new readers to conduct their analysis. We expect to report top-line results in the first quarter of 2011 which, if positive, may support product registration. There are more than 300,000 MRIs conducted in the U.S. and Europe each year that could benefit from RG1068, a potential market opportunity of over $100 million.
RG2417 for Bipolar Disorder
We have completed enrollment in our Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. The study enrolled 175 patients at 29 clinical sites within the United States. The primary objective of the Phase 2b study is to assess the efficacy of RG2417 on the symptoms of bipolar depression by demonstrating a greater improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) score of the patients receiving RG2417 when compared to placebo over an 8-week treatment period. MADRS is a standardized, rater-administered scale, which has been used for numerous drug trials in bipolar disorder. In addition, the study will assess the safety of RG2417 in patients with bipolar depression including, lack of induction of mania as measured by the Young's Mania Rating Scale. Additional secondary and exploratory objectives include improvements in the Clinical Global Impression scale, difference in MADRS scores after 8 weeks of therapy, and responder rate as defined as percent of patients with an improvement in MADRS score of greater than 50% from baseline to week 8. We expect to report top-line results of the Phase 2b study in the first quarter of 2011.
This study is designed to confirm and extend the results of a Phase 2a study in which 6 weeks of treatment with RG2417 improved the symptoms of bipolar depression when compared to placebo as measured by the MADRS. In the Phase 2a study, a lower placebo effect was observed in those patients with more numerous episodes of mania and depression experienced during their lifetime resulting in a higher apparent therapeutic effect of RG2417, which will also be assessed in the Phase 2b study.
Bipolar disorder is a chronic illness associated with substantial morbidity and mortality, ranking worldwide behind unipolar depression and alcohol abuse among psychiatric illnesses for related disabilities and overall economic burden of illness. The lifetime financial burden of bipolar disorder in the United States is about $600,000 per patient, depending on resistance to treatment and persistence of symptoms. Although several therapies are approved for the treatment of bipolar disorder, many individuals are unable to tolerate the treatment-related side effects, and incomplete clinical response, relapse and recurrence remain common clinical problems. There are more than five million adults worldwide with bipolar disorder, which is an area of high unmet medical need due to the ineffectiveness and significant side effects of current therapies.
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