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Q3/10 Results, Osiris Therapeutics (OSIR)

OSIR reported net Income of $4.5M or $0.14 per share.

Q3/10 revenue (amortized) from collaborations, government contracts and royalties were $10.8M. R&D expenses were $5.5M.  The $10.7M decrease in R&D expenses (from Q3/09) reflects the completion of clinical work associated with Phase 3 clinical trials. G&A expenses were $1.3M. Net cash used in continuing operations for was $8M. Income (loss) from continuing operations was $4.5M. Weighted average diluted shares were 33.M. Net income (loss) for Q3/10 was $4.5M compared to a loss from continuing operations of $6.8M in Q3/09.

  • As of 9/30/10, Osiris had $76.5M of cash, receivables and short-term investments.

Q3/10 Highlights

  • Prochymal New Drug Submission (NDS) under Priority Review for full marketing approval by the Biologics and Genetic Therapies Directorate of Health Canada for graft vs. host disease (GvHD);
  • Request for Pre-BLA (Biologics License Application) meeting submitted to the FDA to prepare for the upcoming Prochymal BLA submission for GvHD;
  • Received Orphan Drug designation from Swissmedic, the Swiss Agency for Therapeutic Products, for Prochymal as a treatment for GvHD, making the drug eligible for expedited review;
  • In conjunction with partners at Genzyme, OSIR is making progress towards the goal of winning approval of the world’s first stem cell therapy.