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Biosurgery sales rise 43% over prior quarter, Prochymal® becomes
first approved stem cell drug and company ends the first half with
Highlights and Recent Developments
"This past quarter was not only memorable, but monumental, for Osiris,"
stated
Second Quarter Financial Results
Biosurgery product revenue rose 43% from the previous quarter to
Research and development expenses for the second quarter of 2012 were
Webcast and Conference Call
A webcast and conference call to discuss the financial results is
scheduled for today,
A replay of the conference call will be available approximately two
hours after the completion of the call through
About
Osiris, Prochymal, Grafix and Ovation are registered trademarks of
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
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| Condensed Balance Sheets | |||||||||||
| Amounts in thousands, except per share data | |||||||||||
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| (Unaudited) | |||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash | $ | 1,109 | $ | 1,661 | |||||||
| Investments available for sale | 37,637 | 45,604 | |||||||||
| Accounts receivable | 1,393 | 728 | |||||||||
| Inventory | 475 | 767 | |||||||||
| 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 | |||||||||
| Restricted cash | 392 | 392 | |||||||||
| Total assets | $ | 46,530 | $ | 54,273 | |||||||
| Liabilities and Stockholders' Equity | |||||||||||
| Current liabilities: | |||||||||||
| 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 | |||||||||
| Total liabilities | 5,571 | 8,455 | |||||||||
| Stockholders' equity | |||||||||||
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Common stock, |
|||||||||||
| authorized, 32,868 shares outstanding - 2012, | |||||||||||
| 32,828 shares outstanding - 2011 | 33 | 33 | |||||||||
| Additional paid-in-capital | 278,785 | 278,092 | |||||||||
| Accumulated other comprehensive income | 5 | 20 | |||||||||
| Accumulated deficit | (237,864 | ) | (232,327 | ) | |||||||
| Total stockholders' equity | 40,959 | 45,818 | |||||||||
| Total liabilities and stockholders' equity | $ | 46,530 | $ | 54,273 | |||||||
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| Condensed Statements of Operations | ||||||||||||||||||||
| (Unaudited) | ||||||||||||||||||||
| Amounts in thousands, except per share data | ||||||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||||||
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June 30, | |||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||||||
| Product revenues | $ | 1,626 | $ | 130 | $ | 2,763 | $ | 167 | ||||||||||||
| Cost of product revenues | 552 | 55 | 939 | 70 | ||||||||||||||||
| Gross profit | 1,074 | 75 | 1,824 | 97 | ||||||||||||||||
| Revenue from collaborative research agreements and royalties | 98 | 10,224 | 3,544 | 20,619 | ||||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | 4,072 | 5,209 | 8,035 | 9,920 | ||||||||||||||||
| General and administrative | 1,418 | 3,280 | 2,941 | 4,976 | ||||||||||||||||
| 5,490 | 8,489 | 10,976 | 14,896 | |||||||||||||||||
| (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 | ||||||||||||||||
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||||||||||
| Statements of Cash Flows | ||||||||||
| (Unaudited) | ||||||||||
| Amounts in thousands | ||||||||||
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Six months ended, |
||||||||||
| June 30, | ||||||||||
| 2012 | 2011 | |||||||||
| 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: | ||||||||||
| Accounts receivable | (676 | ) | 1,263 | |||||||
| Inventory, prepaid expenses, and other current assets | (421 | ) | (120 | ) | ||||||
| Other assets | - | 149 | ||||||||
| Accounts payable and accrued expenses | 449 | (1,195 | ) | |||||||
| Deferred revenue | (3,333 | ) | (20,480 | ) | ||||||
| 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 | ||||||
OsirisPR@Osiris.com
Source:
News Provided by Acquire Media