- Achieved an historic, first approval from Health Canada to market its stem cell drug, Prochymal ( remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children.
- Obtained a second approval for Prochymal in New Zealand, through its medical regulatory agency, Medsafe.
- Attained a transitional pass-through status from the Center for Medicare & Medicaid Services (CMS), with C-Codes being designated for Grafix®. Also, CMS also issued a preliminary positive decision for the assignment of permanent Healthcare Common Procedure Coding System (HCPCS) Q-codes.
- In the largest study of allogeneic or "off-the-shelf" stem cells ever conducted in heart attack patients, reported interim one-year results showing that treatment with Prochymal resulted in a statistically significant reduction in heart failure in patients experiencing first-time acute myocardial infarction.
- Selected by the Biomedical Advanced Research and Development Authority (BARDA) to submit a full proposal for a Broad Agency Announcement (BAA) to fund advanced research and development of countermeasures, specifically for the use of Grafix in mass casualty thermal burn injuries.
- Reported $1.6 million of revenue from the distribution of our Biosurgery products during the second quarter – a 43% increase over the previous quarter.
- Reported cash, receivables and short-term investments of $40.1 million as of June 30, 2012.
Second Quarter Financial ResultsBiosurgery product revenue rose 43% from the previous quarter to $1.63 million. As of June 30, 2012, Osiris had $40.1 million of cash, receivables and short-term investments. Research and development expenses for the second quarter of 2012 were $4.1 million, compared to $5.2 million incurred in the second quarter of 2011. General and administrative (G&A) expenses were $1.4 million for the second quarter of 2012 compared to $3.3 million for the same period of the prior year. The 2011 G&A expense included a non-cash charge of $1.7 million related to the extension of the expiration date of a warrant. Net cash used in operations for the three months ended June 30, 2012 was $4.4 million. Webcast and Conference Call A webcast and conference call to discuss the financial results is scheduled for today, July 30, 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 (877) 303-6133 (U.S. participants) or (970) 315-0493 (international participants). A replay of the conference call will be available approximately two hours after the completion of the call through August 05, 2012. Callers can access the replay by dialing (855) 859-2056 (U.S. participants) or (404) 537-3406 (international participants). The audio replay confirmation code is 99408506. 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., having developed the world’s first approved stem cell drug, Prochymal®, is the leading stem cell company. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. In Biosurgery, Osiris currently markets Grafix® for burns and chronic wounds, and Ovation® for orthopedic applications. 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 48 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 may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our 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 mesenchymal stem cells and biologic drug candidates and marketed Biosurgery products (including Prochymal®, Chondrogen®, Grafix® and Ovation®); our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to treat disease; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available, products to meet demand; our costs to comply with governmental regulations; our relationship with collaborating partners; our ability to maintain and benefit from our collaborative arrangements; our ability to benefit from government contracts; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and 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, except per share data|
|June 30, 2012||December 31, 2011|
|Investments available for sale||37,637||45,604|
|Deferred tax asset||-||2,188|
|Prepaid expenses and other current assets||3,371||470|
|Total current assets||43,985||51,418|
|Property and equipment, net||2,153||2,463|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$||5,166||$||4,692|
|Deferred revenue, current portion||-||3,333|
|Total current liabilities||5,166||8,025|
|Other long-term liabilities||405||430|
|Common stock, $.001 par value, 90,000 shares|
|authorized, 32,868 shares outstanding - 2012,|
|32,828 shares outstanding - 2011||33||33|
|Accumulated other comprehensive income||5||20|
|Total stockholders' equity||40,959||45,818|
|Total liabilities and stockholders' equity||$||46,530||$||54,273|
|OSIRIS THERAPEUTICS, INC.|
|Condensed Statements of Operations|
|Amounts in thousands, except per share data|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Cost of product revenues||552||55||939||70|
|Revenue from collaborative research agreements and royalties||98||10,224||3,544||20,619|
|Research and development||4,072||5,209||8,035||9,920|
|General and administrative||1,418||3,280||2,941||4,976|
|(Loss) income from operations||(4,318||)||1,810||(5,608||)||5,820|
|Other income, net||21||25||39||54|
|(Loss) income before income taxes||(4,297||)||1,835||(5,569||)||5,874|
|Income tax benefit (expense)||32||(43||)||32||(43||)|
|Net (loss) income||$||(4,265||)||$||1,792||$||(5,537||)||$||5,831|
|Basic (loss) earnings per share||$||(0.13||)||$||0.05||$||(0.17||)||$||0.18|
|Diluted (loss) earnings per share||$||(0.13||)||$||0.05||$||(0.17||)||$||0.18|
|Weighted average common shares (basic)||32,860||32,821||32,845||32,814|
|Weighted average common shares (diluted)||32,860||33,134||32,845||33,124|
|OSIRIS THERAPEUTICS, INC.|
|Statements of Cash Flows|
|Amounts in thousands|
|Six months ended,|
|Cash flows from operating activities:|
|Net (loss) income||$||(5,537||)||$||5,831|
|Adjustments to reconcile net (loss) income|
|to net cash used in operating activities:|
|Depreciation and amortization||348||375|
|Non cash share-based payments||687||994|
|Provision for bad debts||11||-|
|Non cash expense- extension of expiration date of warrant to related party||-||1,740|
|Changes in operating assets and liabilities:|
|Inventory, prepaid expenses, and other current assets||(421||)||(120||)|
|Accounts payable and accrued expenses||449||(1,195||)|
|Net cash used in operating activities||(8,472||)||(11,443||)|
|Cash flows from investing activities:|
|Purchases of property and equipment||(38||)||(40||)|
|Proceeds from sale of investments available for sale||7,985||11,555|
|Purchases of investments available for sale||(33||)||(5||)|
|Net cash provided by investing activities||7,914||11,510|
|Cash flows from financing activities:|
|Proceeds from the issuance of common stock, net||6||1|
|Net cash provided by financing activities||6||1|
|Net (decrease) increase in cash||(552||)||68|
|Cash at beginning of period||1,661||1,442|
|Cash at end of period||$||1,109||$||1,510|