Q4/09 Results, Osiris Therapeutics (OSIR)
Osiris Therapeutics is a stem cell therapeutic company focused on developing products in the inflammatory, orthopedic and cardiovascular areas. OSIR’s Q4/09 results reported achievement and data showing Prochymal achieved a 63% response rate when used as a rescue agent in children with end-stage GvHD with significant improvement in response rates over standard of care for both liver and gastrointestinal steroid-refractory GvHD – the two most deadly and difficult-to-treat forms of the disease. Graft-versus-host disease (GvHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as “foreign” and mount an immunologic attack.
Further achievements included:
- OSIR also submitted additional sections of the Biological License Application (BLA) for Prochymal to the FDA,
- Receiving $1.5 M in milestone payments from the Juvenile Diabetes Research Foundation (JDRF) and completed enrollment of the 63 patient Phase II type 1 diabetes trial,
- Expanding the Phase II trial evaluating Prochymal in type 1 diabetes to include pediatric patients,
- Creating a new Biosurgery division focused on developing high-end biologic products for use in surgical procedures,
- Published positive data in the Journal of the American College of Cardiology demonstrating the safety and effectiveness of Prochymal in treating heart attack patients.
OSIR has focused on the advancement of Mesenchymal stem cells (MSC’s) that offer the opportunity to treat patients in acute settings potentially within hours of the onset of symptoms; for example, a patient with an acute heart attack could be treated upon arrival at the emergency room, rather than waiting as individually customized cells are prepared over weeks or months, as is the case with other cell technologies.
- In both animal and human clinical studies, OSIR’s has found that MSC’s are generally not rejected by the host immune system,
- This unique feature eliminates the need to tailor MSC’s based on donor matching and means that patients can forgo the harmful side effects of immune suppression.
- Net income for was $15.7 M with revenues of $10.8 M which consisted primarily from upfront license fees from the Genzyme agreement and in-house Research & Development & Commercialization (R&D&C) agreement with JDRF. Loss from continuing operations were $0.3 M and income from discontinued operations was $16 M (includes the $15 M final milestone payment received from NuVasive after their cumulative sales of Osteocel reached the $35 M threshold). The creation of the Biosurgery Division allowed OSIR to effectively utilize the manufacturing facilities previously used to produce Osteocel, resulting in the reduction of a lease impairment charge recorded in Q1/09. R&D expenses for Q4/09 were $9.9 M, with a 37% decline in R&D expenses reflecting the completion of substantially all clinical work associated with the Phase III clinical trials. G&A expenses were $2.1 M and net cash used in continuing operations was $14.8 M,
- As of 12/31/09, OSIR had $100.7 M of cash and short-term investments.
FY09 Financial Highlights
- Net income was $14.6 M with a loss from continuing operations of $23.6 M Income from discontinued operations in 2009 was $38.1 M. Revenues of $44.5 M were recognized, including $40 M from the Genzyme collaboration agreement, $3 M from the US Department of Defense (DoD) contract and $1.2 M from the R&D&C agreement with the JDRF. R&D expenses were $63.3 M which began to decrease in the 2nd half of 09 as work on Phase III clinical trials was being completed. G&A expenses were $8.8 M.
Reiterating, OSIR’s pipeline of internally developed biologic drug candidates under evaluation include Prochymal for inflammatory, autoimmune and cardiovascular indications as well as Chondrogen for arthritis in the knee.