WALTHAM, Mass., Feb. 4 /PRNewswire-FirstCall/ -- Repligen Corporation today reported results for the third quarter of fiscal year 2010, ended December 31, 2009. Total revenue for the quarter was $5,617,000 compared to total revenue of $6,018,000 for the third quarter of fiscal year 2009 ended December 31, 2008. Total revenue for the third quarter of fiscal year 2010 was comprised of Protein A product revenue of $2,865,000 and royalty and research revenue of $2,752,000, consisting primarily of royalty payments from Bristol-Myers Squibb on the U.S. sales of Orencia(R).
Net loss for the third quarter of fiscal year 2010 was $349,000 or $0.01 per diluted share, compared to a net gain for the third quarter of fiscal year 2009 of $18,000 or $0.00 per diluted share. Cash, cash equivalents and marketable securities as of December 31, 2009 were $61,446,000 compared to $63,961,000 as of March 31, 2009.
For the nine-month period ended December 31, 2009, total revenue was $16,099,000 compared to $24,768,000 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(R) prior to the April 2008 patent licensing agreement. Operating expenses for the nine-month period ended December 31, 2009 were $20,103,000 compared to $17,672,000 for the same period in fiscal year 2009. Net loss for the nine-month period ended December 31, 2009 was $2,435,000 or $0.08 per diluted share compared to a net gain of $8,439,000 or $0.27 per diluted share for the same period in fiscal year 2009.
Therapeutics Business
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. The study is designed to assess the safety and efficacy of RG2417 on the symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression of Change in Bipolar Disorder scale (CGI-BP-C). There are more than five million adults worldwide with bipolar disorder.
DCPS Inhibitors for Spinal Muscular Atrophy
In October, we entered into an exclusive license agreement with Families of Spinal Muscular Atrophy (FSMA) for intellectual property covering compounds which may have utility in treating Spinal Muscular Atrophy (SMA). SMA is an inherited neurodegenerative disease in which a defect in the SMN1 ("survival motor neuron") gene results in low levels of the protein SMN and leads to progressive damage to motor neurons, loss of muscle function and, in many patients, early death. The licensed compounds increase the production of SMN in cells derived from patients. Further testing of these compounds in two transgenic mouse models of SMA demonstrated significantly increased survival suggesting potential clinical utility. SMA is diagnosed in approximately one in every 6,000 births in the United States and Europe where the estimated prevalence is approximately 20,000 patients. There is currently no treatment or cure for SMA.
GE Healthcare Supply Agreement
In January we announced that we have extended our longstanding relationship with GE Healthcare Bio-Sciences AB by entering into a five-year supply agreement for recombinant Protein A, a consumable used in the manufacture of monoclonal antibodies, a highly successful class of biopharmaceutical. Repligen is the world's leading supplier of recombinant Protein A and has manufactured recombinant Protein A for GE Healthcare for more than 10 years. This agreement provides for Repligen to continue to be a strategic supplier to GE Healthcare through 2014. GE Healthcare sells chromatography products which incorporate Repligen's recombinant Protein A to the biopharmaceutical industry for the manufacture of monoclonal antibodies.
Quarterly Conference Call
Repligen will host a conference call and webcast on Thursday, February 4th at 10:00 a.m. EST, to review financial results. This call can be accessed via Repligen's website at www.repligen.com or by calling (800) 510-9836 for domestic calls and (617) 614-3670 for international calls. Participants must provide the following passcode: 51466310.
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance and position, management's strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance such as the anticipated growth in the monoclonal antibody market and our other target markets and projected growth in product sales, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative relationships, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of product revenues and profits, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of litigation regarding our intellectual property rights, our limited sales and manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in Repligen's filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.
CONTACT: Laura Whitehouse, VP, Market Development of Repligen Corporation,
+1-781-419-1812
Web site: http://www.repligen.com/
