Osiris Therapeutics reports second-quarter net income of $1.7M against loss last year

Osiris Therapeutics, Inc.Aug 7 2010

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

“Today, Osiris is in a very strong position”

Highlights and Recent Developments

• Prochymal New Drug Submission (NDS) accepted for review for full marketing approval by the Biologics and Genetic Therapies Directorate of Health Canada for graft vs. host disease (GvHD).
• Granted Priority Review for Prochymal by Health Canada reducing the NDS evaluation period for approval from 300 to 180 days.
• Notified by Health Canada that upon approval, Prochymal will be added to its Register of Innovative Drugs, which confers eight years of market exclusivity.
• 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.
• Recorded net income of $1.7 million for the quarter; $0.05 per diluted common share.
• Reported cash, short-term investments and receivables of $84.4 million at June 30, 2010.

"Today, Osiris is in a very strong position," said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris Therapeutics. "With our excellent partners, solid balance sheet and first-in-class technology, Osiris is confidently executing its mission to gain approval for the world's first stem cell therapy."

First Quarter Financial Results

Net income for the second quarter of 2010 was $1.7 million compared to a loss from continuing operations of $8.6 million in the second quarter of 2009. Revenues were $10.3 million in the second quarter of 2010, consisting primarily of the amortization of license fees from our collaboration agreements. Revenues in the second quarter of 2009 were $10.5 million. As of June 30, 2010, Osiris had $84.4 million of cash, receivables and short-term investments.

Research and development expenses for the second quarter of 2010 were $6.5 million, compared to $18.5 million incurred in the second quarter of 2009. The $12.0 million decrease in R&D expenses reflects the completion of clinical work associated with our Phase 3 clinical trials. General and administrative expenses were $1.6 million for the second quarter of 2010 compared to $2.3 million for the same period of the prior year. Net cash used in continuing operations for the three months ended June 30, 2010 was $5.6 million.