Repligen expects total revenue of $21.0M for fiscal year 2010

Repligen CorporationApr 16 2010

Repligen Corporation (Nasdaq: RGEN) today announced preliminary financial results for fiscal year 2010 which ended March 31, 2010.  Total revenue for the year is expected to be $21.0 million, including $10.3 million of bioprocessing product revenue and $10.7 million of royalty and other revenue.  Research and development expenses are expected to be between $13.8-$14.2 million and selling, general and administrative expenses between $6.8-$7.2 million.  The net loss for the year is expected to be between $3.6-$4.0 million and cash and investments as of March 31, 2010 are expected to be $59.1 million.

For fiscal year 2011, which started on April 1, 2010 and will end on March 31, 2011, we currently expect total revenue to increase to $22-$24 million, which includes an anticipated increase in bioprocessing product revenue of 10-20% to $11.3-$12.4 million.  Research and development expenses are currently expected to decrease to $12-$13 million including expenses associated with a potential re-read of our RG1068 Phase 3 clinical trial images as discussed below.  Selling, general and administrative expenses are currently expected to be $8-$9 million and include investments in our bioprocessing commercial infrastructure and initial market development activities for RG1068.  The net loss for fiscal year 2011 is expected to be $3-$4 million and cash and investments on March 31, 2011 are expected to be $57.5-$58.5 million resulting in a cash burn of approximately $1 million for the year.  This current outlook for fiscal year 2011 is based on current operating plans and excludes potential product acquisitions or licensing events currently under discussion.

"While, as always, there are a number of external factors that could influence our actual results for this next year, I am optimistic that we are beginning to see a return to growth for our bioprocessing business," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation.  "Our revenues support development of our existing pipeline with minimal cash burn and also allow us to actively seek acquisition opportunities to build our therapeutic and bioprocessing businesses."

Fiscal Year 2011 Program Goals

RG1068 for MRI Imaging of the Pancreas

In February we filed a submission to the Food and Drug Administration (FDA) in which we described multiple issues with the analysis of the radiographic images by the contract research organization (CRO) hired to oversee analysis of the Phase 3 trial data.  We also submitted a protocol to the FDA to hire a new CRO and re-analyze the images from our Phase 3 study to establish the utility of RG1068 in improving MRI imaging of the pancreas (Phase 3 re-read).  Based on discussions with the FDA, we plan to submit a revised plan for a potential Phase 3 re-read as well as additional data related to the issues at the CRO in preparation for a meeting with the FDA in May.  We have also submitted a Phase 3 re-read proposal to the European Medicines Agency.  They have indicated that they are open to a re-read of the Phase 3 data, and they have requested submission of a revised protocol which includes new endpoints related to the impact of the identification of structural abnormalities on clinical decision making.  We intend to discuss a revised protocol with the EMA this month.

RG2417 for Bipolar Depression

We are currently enrolling a Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression at 19 clinical sites in the United States.  We have recruited 135 patients and to date approximately 70 patients have completed the protocol.  We plan to recruit a total of 150-170 patients and expect to report top line results of the study by the end of the year.

HDAC-3 Inhibitors for Friedreich's Ataxia

We are currently developing inhibitors of histone deacetylase 3 (HDAC-3) for the treatment of inherited neurodegenerative diseases such as Friedreich's ataxia.  Preclinical studies have shown that specific HDAC-3 inhibitors increase production of the protein frataxin which may have the potential to arrest disease progression in patients with Friedreich's ataxia.  We plan to file an Investigational New Drug Application (IND) for a Phase 1 human clinical study of RG2833 in healthy volunteers this quarter.