Osiris Therapeutics Inc.
) reported a third quarter loss of 9 cents per share, narrower
than the Zacks Consensus Estimate of a loss of 14 cents. However,
year-ago earnings were 12 cents per share. Revenues for the
quarter came in at $2.4 million, above the Zacks Consensus
Estimate of $2 million but well below the year-ago revenues of
Biosurgery product sales came in at $2.2 million, up 32% from
the second quarter of 2012.
Research and development (R&D) expenses declined 40.6%
from the year-ago period to $3.0 million, mainly due to the
completion of enrollment in the myocardial infarction study with
Prochymal. General and administrative expenses increased 12% from
the year-ago period to $1.6 million due to higher commercial
activities in the Biosurgery segment.
Osiris has made significant progress with stem cell therapies.
The upside potential to lead candidate Prochymal could be
enormous. Prochymal gained approval in Canada and New Zealand in
the second quarter of 2012 for the treatment of acute
graft-vs-host disease (GvHD) in children. Prochymal is the first
manufactured stem cell product to gain approval and the first
treatment to gain approval for GvHD.
Besides being approved in Canada and New Zealand, we note that
the product is available under an Expanded Access Program (EAP)
in seven countries including the US. The company is currently
finalizing reimbursement plans in Canada. Osiris is 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, most of which
are blockbuster indications.
As far as the Crohn's disease indication is concerned, Osiris
said that enrolment for a phase III study continues.
Meanwhile, the company completed enrolling patients in a phase
II trial that is studying Prochymal for the treatment of severe
myocardial infarction. Osiris presented encouraging interim data
from this trial in the second quarter of 2012.
Regains Osiris Rights
During the third quarter of 2012, Osiris regained global
rights to Prochymal and Chondrogen from Genzyme, a
) company. The amicable ending of the dispute between the
companies has removed a significant overhang for Osiris. We are
positive on this development which will now allow the company to
pursue collaboration agreements for Prochymal and Chondrogen with
We currently have a Neutral recommendation on Osiris, which
carries a Zacks #3 Rank (short-term Hold rating). We expect
investor focus to remain on the commercialization of Prochymal in
Canada and pipeline progress.
OSIRIS THERAPTC (OSIR): Free Stock Analysis
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