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Osiris (OSIR) Q4/12 And FY12 Results

A Q4/12 net loss of $2.6 M or 40.08 per share

A Q4/12 net loss of $2.6 M or 40.08 per share compared to a Q4/11 net loss of $5 M or $0.15 per share and a net loss of $11.1 M or $0.34 for FY12 which compared to a net income of $14.9 M or $0.45.

Q/4 revenues were $3.1 M, including Biosurgery product revenues of $2.9 M compared to $0.8 M in Q4/11. Gross margin was 70% compared to 58% during Q4/11. Gross profit was $2.1 M during Q4/12 and $0.4 M during Q4/11. OSIR reported a loss of $2.6 M R&D expenses were $3.1 M, compared to $4.2 M in Q4/11. G&A expenses were $1.8 M for Q4/12 compared to $1.5 M in Q4/11. Shares used to compute the net loss were 32.87 M.

As of 12/31/12, OSIR had $37.2 M in cash, receivables and short-term investments.

Full Year 2012: Reported product revenue of $7.8 M in 2012- representing a 520% increase over the prior year and 4Q12 revenue increasing 36% over 3Q12. Revenues of $11.8 M were recognized in 2012, including $7.8 M in Biosurgery product revenues compared to $1.3 M over the same period in FY11. OSIR recognized $42.4 M of total revenues in 2011, including $40 M from the Genzyme collaboration agreement, $1 M from the research, development and commercialization agreement with the JDRF and $1.3 M of revenues from Biosurgery products. Gross margin during FY12 was 67% compared to 58% during FY11. Gross profit was $5.3 M during FY12 and $0.7 M during FY11. OSIR reported a loss of $11.1 M for the FY12. R&D expenses for the 2012 fiscal year were $14.1 M compared to $19.2 M in FY11. G&A expenses in fiscal 2012 were $6.3 M, compared to FY11 of $7.9 M, including $2.6 M of non-cash share-based payments. Shares used to compute the net loss were 32.85 M

Q4/12 and FY12 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 US;
  • Launched CartiformTM, viable cartilage mesh for the treatment of articular cartilage injury;
  • Attained transitional pass-through status from the Center for Medicare & Medicaid Services (NYSE:CMS) for Grafix, with Healthcare Common Procedure Coding System (HCPCS) C-Codes being designated and assignment of permanent HCPCS Q-codes.

The Bottom Line: Osiris leapt to $9.61 from $6.91 on Wednesday after had managed to keep its Q4 loss in better check than what analysts had forecast. For Osiris, it was also a year of commercial transformation, having 4 products on the market and expanding capabilities in development, manufacturing, sales and marketing. OSIR's Q4/12, was narrower than one consensus estimate of a loss of $0.15 cents. However, FY11 earnings were -$0.15 per share. Revenues were slightly below Estimate of $3.1 M but well above the year-ago revenues of $0.8 M.OSIR is still working with regulatory agencies across the world to provide them with the information needed to approve Prochymal. Osiris is studying Prochymal for several indications including Crohn's disease and acute myocardial infarction, which are blockbuster indications. As far as the Crohn's disease indication is concerned, OSIR said that enrolment for a P3 study continues. OSIR is actively looking for a partner for Prochymal. Last year, Osiris had regained commercial rights for Prochymal and Chrondogen from Sanofi (NYSE:SNY). OSIR is trading well above their 50 <$7.84) and 200 day <$9.12> moving averages

BUY - OSIR was UP in the pre-market but, has been trading DOWN -$0.28 or -2.99% to $9.07 - a SELL on strenght - let it settle down and come back.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.