Nov. 5, 2009 (PR Newswire) --

WALTHAM, Mass., Nov. 5 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) today reported results for the second quarter of fiscal year 2010, ended September 30, 2009. Total revenue for the quarter was $5,421,000 compared to total revenue of $5,090,000 for the second quarter of fiscal year 2009 ended September 30, 2008. Total revenue for the second quarter of fiscal year 2010 was comprised of Protein A product revenue of $2,742,000 and royalty and research revenue of $2,679,000, consisting primarily of royalty payments from Bristol-Myers Squibb on the U.S. sales of Orencia(®).

Operating expenses for the second quarter of fiscal year 2010 were $6,627,000 compared to $5,414,000 for the same time period in fiscal year 2009. This increase in operating expenses of $1,213,000 was primarily the result of increased spending associated with our Phase 3 clinical trial of RG1068 for pancreatic imaging, our Phase 2b clinical trial of RG2417 for bipolar depression, and increased research and development costs associated with our efforts to identify a clinical candidate for Friedreich's ataxia. Selling, general and administrative expenses have also increased $359,000 due to expanded business development activities compared to the prior year.

Net loss for the second quarter of fiscal year 2010 was $980,000 or $0.03 per diluted share, compared to a net gain for the second quarter of fiscal year 2009 of $142,000 or $0.00 per diluted share. Cash, cash equivalents and marketable securities as of September 30, 2009 were $60,224,000 compared to $63,961,000 as of March 31, 2009.

"This quarter we have made significant progress on achieving both the clinical development and business development objectives we established for this year," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "We are on track to announce the results of our Phase 3 clinical trial of RG1068 in MRI imaging of the pancreas before the end of the year."

For the six-month period ended September 30, 2009, total revenue was $10,481,000 compared to $18,750,000 for the same period in fiscal year 2009. The prior year results were favorably impacted by a one-time payment of $6,330,000 by Bristol Myers Squibb Company for royalties on the U.S. sales of Orencia(®) prior to the April 2008 patent licensing agreement. Operating expenses for the six-month period ended September 30, 2009 were $13,116,000 compared to $11,117,000 for the same period in fiscal year 2009. Net loss for the six-month period ended September 30, 2009 was $2,086,000 or $0.07 per diluted share compared to a net gain of $8,421,000 or $0.27 per diluted share for the same period in fiscal year 2009.

Corporate Update

RG1068 for Imaging of the Pancreas

In October, we completed patient treatment in our Phase 3 clinical trial of RG1068, synthetic human secretin, in magnetic resonance imaging (MRI) of the pancreas. The study is designed to assess the sensitivity and specificity of RG1068 in conjunction with MRI for the detection of pancreatic duct abnormalities compared to MRI alone. Additional assessments include safety, physician confidence in the identification of structural abnormalities, the number of pancreatic duct segments visualized and the improvement in the quality of the MRI images. The study enrolled 258 patients at 23 clinical sites within the United States and Canada, and we expect to release top-line results for the study later this year. Detailed visual assessment of the pancreatic ducts is important in the diagnosis and treatment of diseases such as acute and chronic pancreatitis. The FDA has granted this program Fast Track Designation, a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need. There are currently more than 300,000 MRI procedures conducted in the U.S. and Europe each year that could benefit from the use of RG1068.

RG2417 for Bipolar Disorder

We are currently enrolling a Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial in which approximately 150 patients with bipolar depression will receive either RG2417 or a placebo twice a day for eight weeks.