Osiris Therapeutics Reports Fourth Quarter and Full Year 2011 Financial Results

COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and commercializing products to treat medical conditions in inflammatory, cardiovascular, orthopedic, and wound healing markets, announced today its results for the fourth quarter and full year ended December 31, 2011.

Recent and Full Year Highlights

• Expanded the company’s commercial infrastructure for our lead products Grafix® and Ovation®, increasing Biosurgery revenue in the fourth quarter more than 130% over the previous quarter.
• Achieved top scoring abstract at the 24^th Annual Symposium on Advanced Wound Care for one of three abstracts the company presented describing the science and initial clinical results of Grafix, a living skin substitute.
• Fully filed response to inquiries from the Biologics and Genetic Therapies Directorate of Health Canada regarding the Prochymal New Drug Submission (NDS) and post marketing commitments.
• Inspected by the U.S. Food and Drug Administration with no deficiencies noted.
• Received International Organization for Standardization (ISO) medical device certification, an internationally recognized quality standard.
• Completed enrollment in a 220-patient Phase 2 trial of Prochymal for patients experiencing their first heart attack.
• Reported update on first-of-a-kind Phase 2 trial evaluating Prochymal for newly diagnosed type 1 diabetes, conducted in partnership with JDRF.
• Reported cash, receivables, and short-term investments of $48.0 million at year-end.

“We are very pleased with the commercial performance of our two Biosurgery products, Grafix and Ovation,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. “As interest in stem cell products for surgical applications intensifies, Osiris remains uniquely positioned as the clear leader in this space. Additionally, with Prochymal being used around the world to treat patients with life-threatening GvHD through our Expanded Access program, our Therapeutic and Biosurgery units are carrying out our mission of bringing Smart Medicine, to patients, Right Now.”

Fourth Quarter Financial Results

Net income for the fourth quarter of 2011 increased to $5.0 million, compared to $4.4 million for the fourth quarter of 2010. Revenues were $11.0 million in the fourth quarter of 2011, consisting primarily of the amortization of license fees from our collaboration agreements. Our fourth quarter Biosurgery product revenues were $0.8 million. Revenues during the fourth quarter of 2010 were $10.8 million. As of December 31, 2011, Osiris had $48.0 million of cash, receivables, and short-term investments.

Research and development expenses for the fourth quarter of 2011 were $4.2 million, compared to $5.0 million incurred in the fourth quarter of 2010. General and administrative expenses were $1.5 million for the fourth quarter of 2011 compared to $1.8 million for the same period of the prior year. Net cash used in operations for the quarter was $4.6 million.

Full Year 2011 Financial Highlights

Net income was $14.9 million for the fiscal year ended December 31, 2011 compared to $13.1 million in fiscal 2010. Revenues of $42.4 million were recognized in 2011, including $40.0 million from the Genzyme collaboration agreement, $1.0 million from the research, development and commercialization agreement with the JDRF and $1.3 million of revenues from our Biosurgery products. Revenues in 2010 were $43.2 million, which included $40.0 million from the Genzyme collaboration agreement, $0.5 million from the U.S. Department of Defense contract, $1.2 million from the JDRF agreement and a $1.0 million milestone earned on our license agreement with JCR Pharmaceuticals.

R&D expenses for the 2011 fiscal year were $19.2 million compared to $23.5 million in the prior year. G&A expenses in fiscal 2011 were $7.9 million, which include $2.4 million of non-cash share based payments. G&A expenses in fiscal 2010 were $6.5 million, including $0.7 million of share-based payments.

Webcast and Conference Call

A webcast and conference call to discuss the financial results is scheduled for today, March 9, 2012 at 9:00 a.m. ET. To access the webcast, 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 [phone] (U.S. participants) or [phone] (international participants).

A replay of the conference call will be available approximately two hours after the completion of the call through March 15, 2012. Callers can access the replay by dialing [phone] (U.S. participants) [phone] (international participants). The audio replay passcode is 54951517. 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 the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, and orthopedic areas and wound healing. Osiris currently markets and distributes Grafix and Ovation for tissue repair. The company's pipeline of internally developed biologic drug candidates under evaluation includes Prochymal for inflammatory, autoimmune and cardiovascular indications, as well as Chondrogen for arthritis in the knee. Osiris is a fully integrated company, with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 46 U.S. and 144 foreign patents.

Osiris, Prochymal, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. 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 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 and the ability to successfully navigate these 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 Prochymal, Chondrogen and our other MSC and biologic drug candidates; our cash needs; patents and proprietary rights; the safety and ability of our potential products to treat disease and the results of our scientific research; 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 and other Periodic Reports filed on Form 10-Q, 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.

OSIRIS THERAPEUTICS, INC. Condensed Balance Sheets Amounts in thousands
	December 31, 2011			December 31, 2010
Assets
Current assets:
Cash	$	1,661		$	1,442
Investments available for sale		45,604			66,166
Accounts receivable		728			1,928
Inventory		767			510
Deferred tax asset		2,188			3,170
Prepaid expenses and other current assets		470			736
Total current assets		51,418			73,952
Property and equipment, net		2,463			3,127
Restricted cash		392			521
Other assets		-			184
Total assets	$	54,273		$	77,784
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued expenses	$	4,692		$	5,569
Deferred revenue, current portion		3,333			40,960
Total current liabilities		8,025			46,529
Deferred revenue, net of current portion		-			3,333
Other long-term liabilities		430			465
Total liabilities		8,455			50,327
Stockholders' equity
Common stock, $.001 par value, 90,000 shares authorized, 32,828 shares outstanding - 2011, 32,794 shares outstanding - 2010		33			33
Additional paid-in-capital		278,092			274,646
Accumulated other comprehensive income (loss)		20			(3	)
Accumulated deficit		(232,327	)		(247,219	)
Total stockholders' equity		45,818			27,457
Total liabilities and stockholders' equity	$	54,273		$	77,784

OSIRIS THERAPEUTICS, INC. Condensed Statements of Operations Amounts in thousands, except per share data
	Three Months Ended December 31,				Year Ended December 31,
	2011		2010		2011			2010
	(unaudited)
Product revenues	$	765	$	84	$	1,263		$	183
Cost of product revenues		322		28		531			62
Gross profit		443		56		732			121
Revenue from collaborative research agreements, government contract and royalties		10,279		10,681		41,140			43,021
Operating expenses:
Research and development		4,218		5,025		19,156			23,501
General and administrative		1,476		1,773		7,881			6,450
		5,694		6,798		27,037			29,951
Income from operations		5,028		3,939		14,835			13,191
Other income, net		20		24		100			175
Income before income taxes		5,048		3,963		14,935			13,366
Income tax benefit (expense)		-		451		(43	)		(241	)
Net income	$	5,048	$	4,414	$	14,892		$	13,125
Basic earnings per share	$	0.15	$	0.13	$	0.45		$	0.40
Diluted earnings per share	$	0.15	$	0.13	$	0.45		$	0.40
Weighted average common shares (basic)		32,827		32,792		32,820			32,784
Weighted average common shares (diluted)		33,111		33,113		33,118			33,097

OSIRIS THERAPEUTICS, INC. Condensed Statements of Cash Flows Amounts in thousands
	Year ended December 31,
	2011			2010
Cash flows from operating activities:
Continuing operations
Income (loss) from continuing operations	$	14,892		$	13,125
Adjustments to reconcile income (loss) from continuing operations to net cash used in operations:
Depreciation and amortization		745			755
Non cash share-based payments		1,684			1,684
Provision for bad debts		3			-
Deferred tax benefit		-			(3,170	)
Non cash expense- extension of expiration date of warrant to related party		1,740			-
Changes in operating assets and liabilities:
Accounts receivable		1,197			(790	)
Inventory, prepaid expenses, and other current assets		991			(298	)
Other assets		184			211
Accounts payable and accrued expenses		(912	)		(3,403	)
Deferred revenue		(40,960	)		(40,891	)
Net cash used in continuing operations		(20,436	)		(32,777	)
Discontinued operations
Changes in operating assets and liabilities:
Accounts payable and accrued expenses		-			(412	)
Net cash used in discontinued operations		-			(412	)
Net cash used in operating activities		(20,436	)		(33,189	)
Cash flows from investing activities:
Purchases of property and equipment		(81	)		(148	)
Proceeds from sale of investments available for sale		20,805			33,598
Purchases of investments available for sale		(220	)		(270	)
Net cash provided by investing activities		20,504			33,180
Cash flows from financing activities:
Principal payments on capital lease obligations and notes payable		-			(3	)
Restricted cash		129			145
Proceeds from the issuance of preferred and common stock, net		22			3
Net cash provided by financing activities		151			145
Net increase in cash		219			136
Cash at beginning of period		1,442			1,306
Cash at end of period	$	1,661		$	1,442