Osiris Therapeutics reports net income of $2.4M for first-quarter 2010

Osiris TherapeuticsMay 7 2010

Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell therapeutic company focused on developing and marketing products to treat medical conditions in the inflammatory, cardiovascular and orthopedic areas, announced today its results for the first quarter of fiscal 2010.

“We're pleased with the progress we've made across many of our programs including Crohn's disease, type 1 diabetes and GvHD”

Highlights and Recent Developments

• Announced the positive interim analysis of the first 207 patients in a clinical trial evaluating Prochymal for treatment-resistant Crohn's disease.
• Granted Orphan Drug designation from the Food and Drug Administration (FDA) for Prochymal as a treatment for type 1 diabetes.
• Achieved $1.0 million milestone from JCR Pharmaceuticals for development progress with Prochymal in Japan.
• Reported data showing Prochymal achieved a 63% response rate when used as a rescue agent in children with end-stage graft versus host disease (GvHD).
• Presented data showing Prochymal significantly improves response rates over standard of care for both liver and gastrointestinal steroid-refractory GvHD.
• Recorded net income of $2.4 million for the quarter; $0.07 per diluted common share.
• Reported cash, short-term investments and receivables of $91.2 million at March 31, 2010.

"We're pleased with the progress we've made across many of our programs including Crohn's disease, type 1 diabetes and GvHD," said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris Therapeutics. "Given our strong balance sheet, financial discipline and practical approach to drug development, we are well-positioned to bring this first-in-class technology to the patients who need it most."

First Quarter Financial Results

Net income for the first quarter of 2010 was $2.4 million compared to a loss from continuing operations of $7.9 million in the first quarter of 2009. Net income for the first quarter of 2009 of $14.8 million included $22.7 million of income from discontinued operations. Revenues were $11.4 million in the first quarter of 2010, consisting primarily of upfront license fees from the Genzyme agreement and a $1.0 million milestone payment achieved from our collaboration with JCR Pharmaceuticals for development progress of Prochymal in Japan. Revenues in the first quarter of 2009 were $12.7 million. As of March 31, 2010, Osiris had $91.2 million of cash, receivables and short-term investments.

Research and development expenses for the first quarter of 2010 were $6.6 million, compared to $18.6 million incurred in the first quarter of 2009. The $12.0 million decrease in R&D expenses reflects the completion of clinical work associated with our Phase III clinical trials. General and administrative expenses were $1.8 million for the first quarter of 2010 compared to $2.9 million for the same period of the prior year. Net cash used in continuing operations for the quarter was $10.6 million.