Osiris Therapeutics, Inc. (NASDAQ: OSIR) the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today its results for the fourth quarter and full year ended December 31, 2012.
Recent and Full Year Highlights
- Achieved world’s first approval for a stem cell drug from Health Canada to market Prochymal® ( remestemcel-L) for the treatment of acute graft versus host disease (GvHD) in children.
- Established and deployed a direct sales force for Grafix®, a premium cellular repair matrix for serious wounds including diabetic foot ulcers, in 10 major metropolitan areas throughout the United States.
- Launched Cartiform TM, viable cartilage mesh for the treatment of articular cartilage injury.
- Attained transitional pass-through status from the Center for Medicare & Medicaid Services (CMS) for Grafix, with Healthcare Common Procedure Coding System (HCPCS) C-Codes being designated and assignment of permanent HCPCS Q-codes.
- Gross margin improved 12 percentage points to 70% with gross profit increasing to $2.1M for the quarter.
- Reported product revenue of $7.8 million in 2012– representing a 520% increase over the prior year and 4Q12 revenue increasing 36% over 3Q12.
- Reported year-end cash, receivables, and short-term investments of $37.2 million.
“With the approval of Prochymal, 2012 was an historic year for the entire field of stem cell medicine,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. “For Osiris, it was also a year of commercial transformation, having four products on the market and expanding capabilities in development, manufacturing, sales and marketing. Osiris is now a fully integrated commercial cell therapy company, well-positioned for future growth.”
Fourth Quarter Financial ResultsRevenues during the fourth quarter of 2012 were $3.1 million, including Biosurgery product revenues of $2.9 million compared to $0.8 million over the same period of 2011. Gross margin during the fourth quarter was 70% compared to 58% during the fourth quarter of 2011. Gross profit was $2.1 million during the fourth quarter of 2012 and $0.4 million during the same period of 2011. We reported a loss of $2.6 million in the fourth quarter of 2012. As of December 31, 2012, Osiris had $37.2 million in cash, receivables and short-term investments.