Today, Osiris Therapeutics, developer of a powerful stem cell platform with penetration across multiple therapeutic markets extending from the anti-inflammatory, anti-fibrosis, and regenerative properties of the technology, reported financial results for Q4 and FY11.
President and CEO of OSIR, C. Randal Mills, Ph.D., proudly put the spot light on the commercial performance/pipeline expansion of the company’s two winning Biosurgery products, Grafix® and Ovation®, noting that Q4 Biosurgery revenue rose 130% from Q3.
Other highlights include:
• Cash, receivables, and short-term investments: $48.0M
• Net income up 13.6% for Q4 to $5M (from Q3 FY10); up 13.8% for FY11 (from FY10)
• Q4 revenue up 1.9% to $11M; strong amortization of license fees via collaboration agreements, Q4 Biosurgery Revenue alone was $0.8M
• FY11 revenue of $42.4M, down slightly from the previous year; $40M alone hailing from the Genzyme collaboration agreement, $1M linked to ongoing JDRF agreement, and $1.3M from Biosurgery portfolio
• R&D expenses down 16.0%
• G&A expenses down 16.7%
Grafix is a great offering in the wound healing space that has see significant growth in uptake by the market, as the capacity of the product’s engineered, unique process preserves tissue structure using allograft extracellular matrix, cells/MSCs (mesenchymal stem cells, fibroblasts, epithelial cells), and growth factors (drawing on OSIR’s deep Biosurgery competencies). Ovation is a similar concept, using the same basic components, which resolves the problem of allografts not working for periosteum (outer membrane of all bones). It was reported that Grafix also achieved a top scoring abstract describing the science and initial clinical results of this amazing living skin substitute at the 24th Annual Symposium on Advanced Wound Care.
Among the financial and process highlights seen in today’s press release, there was a strong pattern reinforcing OSIR’s lead in stem cell products for surgical applications, something Dr. Mills carefully noted, also explaining that products like Prochymal, the only stem cell therapeutic designated by the FDA with both Orphan Drug and Fast Track status, is being used worldwide to fight deadly acute graft versus host disease (GvHD, a process accelerated in the global market via OSIR’s Expanded Access program). Prochymal also has other applications, again showing the broad spectrum capability of the technology platform, with capacity in Crohn’s disease, heart tissue repair following a heart attack, protecting pancreatic islet cells in patients with type1 diabetes, and the repair of lung tissue for pulmonary disease sufferers. Other MSC and biologic drug candidates like Chondrogen (currently in clinical trials for treating knee osteoarthritis) continue to show progress.
In fact, it was reported that Prochymal has completed enrollment for the 220-patient Phase II trial in post first heart attack cases, in addition to an update being provided on first-of-a-kind Phase II trial evaluation in newly diagnosed type1 diabetes, in partnership with the JDRF (the leading global organization focused on type 1 diabetes).
Other milestones for the year include a deficient-free FDA inspection, ISO medical device certification, and fully filed response from the Biologics and Genetic Therapies Directorate of Health Canada to inquiries about the New Drug Submission for Prochymal and post marketing commitments.
A webcast/conference call discussing the financials is available by visiting Osiris Therapeutics’ website at http://investor.osiris.com/events.cfm
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