Exhibit 99.1
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Osiris Therapeutics Reports First Quarter 2007 Financial Results
BALTIMORE, Maryland - May 14, 2007 - Osiris Therapeutics, Inc. (NASDAQ:OSIR), a leading stem cell therapeutic company focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas, announced today its results for the first quarter ended March 31, 2007.
First Quarter Highlights
– Received FDA clearance to initiate Phase III trial for Crohn’s Disease
– Received FDA Fast Track Status for Prochymal to treat Crohn’s Disease
– Prochymal received European Orphan Drug Designation for Graft vs. Host Disease
– Chondrogen demonstrated safety and preliminary signs of arthritis improvement in Phase I/II study
– Provacel demonstrated safety and efficacy in clinical trial treating heart attack patients
– Completed facility expansion for Osteocel®
“Osiris continues to execute its mission to develop and commercialize stem cell therapeutics,” said C. Randal Mills, Ph.D., President and CEO of Osiris. “During 2007, we have the opportunity to advance multiple products through the development process and better position the Company for drug approval and distribution in markets around the world.”
Financial Highlights for First Quarter 2007
Sales of Osteocel were $2.0 million in the first quarter of 2007 compared to $1.1 million in the prior year’s first quarter. Other revenues were $0.3 million for both the first quarter of 2007 and 2006. Osiris reported a net loss of $11.5 million for the first quarter of 2007 compared to a net loss of $5.1 million for the first quarter of 2006. Research and development expenses were $11 million for the first quarter of 2007 compared to $4.4 million for the first quarter of 2006. The 2007 first quarter loss was largely the result of the advancement of the company’s clinical trials and the impact of the testing and qualification of its newly expanded Osteocel manufacturing facility. At the end of the first quarter Osiris had cash and short-term investments of $29.5 million.
General and administrative (G&A) expenses were $1.5 million for the first quarter of 2007 compared to $1.1 million for the first quarter of 2006. The increase in G&A expenses for the first quarter of 2007 was in part driven by costs to support business growth, and costs associated with becoming a public company. Share-based employee compensation expense recorded for the first quarter of 2007 was $0.2 million compared to $0.1 million for the comparable period in 2006. Net interest expense was $0.3 million for the first quarter of 2007 compared to $0.5 million in the first quarter of 2006.
Web Cast and Conference Call
The Company has scheduled a web cast and conference call to discuss its financial results today, May 14th, at 8:30 AM EDT. To access the web cast, visit the Investor Relations section of the company’s website at http://investor.osiris.com/events.cfm. Alternatively, callers may participate in the conference call by dialing (877) 704-5379 (U.S. participants) or (913) 312-1293 (international participants).
A replay of the conference call will be available approximately two hours after the completion of the call through May 28, 2007. Callers can access the replay by dialing (888) 203-1112 (U.S. participants) or (719) 457-0820 (international participants). The audio replay passcode is 5538451. To access a replay of the webcast, visit the Investor Relations section of the company’s website at http://investor.osiris.com/events.cfm.
About Osiris Therapeutics
Osiris Therapeutics, Inc. is a leading stem cell therapeutic company focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas. Osiris currently markets and sells OSTEOCEL® for regenerating bone in orthopedic indications. PROCHYMAL™ is in Phase III clinical trials and is the only stem cell therapeutic currently designated by FDA as both an Orphan Drug and Fast Track product. The company’s pipeline of internally developed biologic drug candidates under evaluation also includes CHONDROGEN™ for regenerating cartilage in the knee, and PROVACEL™, for repairing heart tissue following a heart attack. Osiris is a fully integrated company, having developed stem cell capabilities in research and development, manufacturing, marketing and distribution. Osiris has developed an extensive intellectual property portfolio to protect the company’s technology in the United States and a number of foreign countries including 47 U.S. and 167 foreign patents owned or licensed. More information can be found on the company’s website, www.Osiris.com. (OSIR-G)
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements provide our current expectations or forecasts of future events. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements include, but are not limited to, statements regarding the following: our product development efforts; our clinical trials and anticipated regulatory requirements; the success of our product candidates in development; status of the regulatory process for our biologic drug candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for MSCs and biologic drug candidates; our cash needs; patents and proprietary rights; ability of our potential products to treat disease; our plans for sales and marketing; our plans regarding our facilities; types of regulatory frameworks we expect will be applicable to our potential products; and results of our scientific research. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.
For additional information, please contact Erica Elchin at 443.545.1834.