Osiris Therapeutics Announces Second Quarter 2013 Financial Results

Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today its results for the second quarter of 2013.

Highlights and Recent Developments
  • Product revenue for the quarter rose to $5.3 million - up 231% from the second quarter of 2012.
  • Gross profit increased to $3.8M for the quarter, on 245% from the second quarter of 2012.
  • Significantly advanced our multicenter, randomized, controlled trial evaluating the efficacy and safety of Grafix® in diabetic foot ulcers – now nearing completion of patient enrollment.
  • Expanded our overall commercial infrastructure, including the addition of direct sales representatives in sports medicine for Cartiform®.
  • Completed a 67 patient clinical evaluation of Grafix across multiple wound types, demonstrating an overall closure rate of 81% with a 71% closure rate in difficult to treat venous leg ulcers.
  • Ended the quarter with a strong cash, receivables and short-term investment position of $33.6 million.

“We are very pleased with the return our new sales team is delivering on our investments in commercial infrastructure as demonstrated by our continued revenue growth,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. “We are also excited about the progress of Protocol 302, our randomized, controlled clinical trial evaluating Grafix for chronic diabetic foot ulcers. By balancing our commercial and developmental activities, we continue to advance towards our goal of creating a profitable business in cell therapy by providing best-in-class products and service.”

Second Quarter Financial Results

Product revenues during the second quarter of 2013 were $5.3 million, compared to $1.6 million during the second quarter of 2012, an increase of 231%. Gross margin during the second quarter was 72% compared to 66% during the second quarter of 2012. Gross profit was $3.8 million during the second quarter of 2013 and $1.1 million during the same period of 2012. The net loss was $3.8 million in the second quarter of 2013 compared to $4.3 M during the second quarter of 2012. As of June 30, 2013, Osiris had $33.6 million in cash, receivables and short-term investments.

Research and development expenses for the second quarter of 2013 were $3.3 million, decreased from the $4.1 million incurred in the second quarter of 2012. As a result of our increased commercial activity, our selling, general and administrative expenses were $4.4 million for the second quarter of 2013, compared to $1.4 million for the same period of the prior year.

Webcast and Conference Call

A webcast and conference call to discuss the financial results is scheduled for today, August 5, 2013, 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). Note that a presentation will accompany the webcast.

An archive of the webcast will be available approximately two hours after the completion of the call. To access the archived 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, having developed the world’s first approved stem cell drug, Prochymal®. Osiris currently markets Grafix and Ovation® for wound and tissue repair, and Cartiform for cartilage repair. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of cell therapy products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 51 U.S. and 162 foreign patents.

Osiris, Prochymal, Chondrogen, Grafix, Ovation and Cartiform 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, Ovation and Cartiform); 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 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.
Condensed Balance Sheets
Amounts in thousands
June 30, 2013   December 31, 2012
Current assets:
Cash $ 1,579 $ 1,854
Investments available for sale 25,626 32,238
Accounts receivable, net 6,406 3,063
Inventory 1,696 1,278
Prepaid expenses and other current assets   356     603  
  Total current assets 35,663 39,036
Property and equipment, net 2,040 2,111
Restricted cash   317     317  
Total assets $ 38,020   $ 41,464  
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable, accrued expenses, and other current liabilities $ 6,826 $ 4,999
Capital lease obligations, current portion   45     44  
Total current liabilities 6,871 5,043
Long-term portion of capital lease obligations 140 162
Other long-term liabilities   329     369  
Total liabilities   7,340     5,574  
Stockholders' equity
Common stock, $.001 par value, 90,000 shares
authorized, 32,989 shares outstanding - 2013,
32,881 shares outstanding - 2012 33 33
Additional paid-in-capital 280,616 279,269
Accumulated other comprehensive loss (86 ) (20 )
Accumulated deficit   (249,883 )   (243,392 )
Total stockholders' equity   30,680     35,890  
Total liabilities and stockholders' equity $ 38,020   $ 41,464  
Condensed Statements of Operations
Amounts in thousands, except per share data
Three Months Ended Six Months Ended
June 30, June 30,
2013 2012 2013 2012
Product revenues $ 5,291 $ 1,626 $ 9,346 $ 2,763
Cost of product revenues   1,482     552     2,617     939  
Gross profit   3,809     1,074     6,729     1,824  
Revenue from collaborative research agreements and royalties 136 98 322 3,544
Operating expenses:
Research and development 3,328 4,072 6,309 8,035
Selling, general and administrative   4,398     1,418     7,287     2,941  
  7,726     5,490     13,596     10,976  
Loss from operations (3,781 ) (4,318 ) (6,545 ) (5,608 )
Other income, net   25     21     54     39  
Loss before income taxes (3,756 ) (4,297 ) (6,491 ) (5,569 )
Income tax benefit   -     32     -     32  
Net loss $ (3,756 ) $ (4,265 ) $ (6,491 ) $ (5,537 )
Basic and diluted net loss per share $ (0.11 ) $ (0.13 ) $ (0.20 ) $ (0.17 )
Weighted average common shares (basic and diluted)   32,958     32,860     32,935     32,845  
Condensed Statements of Cash Flows
Amounts in thousands
      Six months ended
June 30,
2013   2012
Cash flows from operating activities:
Net loss $ (6,491 ) $ (5,537 )
Adjustments to reconcile net loss
to net cash used in operations:
Depreciation and amortization 369 348
Non cash share-based payments 766 687
Provision for bad debts (25 ) 11
Changes in operating assets and liabilities:
Accounts receivable (3,318 ) (676 )
Inventory (418 ) 292
Prepaid expenses, and other current assets 247 (713 )
Accounts payable, accrued expenses, and other current liabilities 1,788 449
Deferred revenue   -     (3,333 )
Net cash used in operating activities   (7,082 )   (8,472 )
Cash flows from investing activities:
Purchases of property and equipment (298 ) (38 )
Proceeds from sale of investments available for sale 6,600 7,985
Purchases of investments available for sale   (54 )   (33 )
Net cash provided by investing activities   6,248     7,914  
Cash flows from financing activities:
Principal payments on capital lease obligations (22 ) -
Proceeds from the issuance of common stock, net   581     6  
Net cash provided by financing activities   559     6  
Net decrease in cash (275 ) (552 )
Cash at beginning of period   1,854     1,661  
Cash at end of period $ 1,579   $ 1,109  

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