Health & Fitness
Health and Fitness
Health and Fitness
Fri, November 19, 2010
Thu, November 18, 2010
Fibrocell Science, Inc. Reports Third Quarter 2010 Financial Results and Provides Business Update
EXTON, Pa.--([ BUSINESS WIRE ])--Fibrocell Science, Inc. (OTCBB: FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced a financial and business update for the third quarter ended September 30, 2010.
"Going forward, we will leverage our intellectual property and the expertise of our advisory board to drive innovation, capitalize on market opportunities for our proprietary technology, and to build value for our shareholders"
Revenue for the third quarter of 2010 was $243,677, compared to $205,769 for the third quarter of 2009. Net loss for the third quarter of 2010 was $1.8 million, compared to net loss of $4.1 million, (excluding the reorganization gain of $74.1 million).
For the nine months ended September 30, 2010, revenue was $716,809, compared to $613,649 for the same period a year ago. Net loss for the nine months ended September 30, 2009 was $8.3 million, compared to net loss of $9.8 million, (excluding the reorganization gain of $73.5 million), for the same period last year.
aWe are pleased with the progress we have made during the quarter towards developing our proprietary cellular technology platform,a commented David Pernock, Fibrocell Science Chairman and CEO. aWe are continuing to work with the FDA regarding our lead therapy azficel-T (proposed trade name laViva") in the treatment of nasolabial fold wrinkles. We are on track to file our response to the FDAa™s Complete Response letter by the end of the fourth quarter of 2010. According to the Prescription Drug User Fee Act (PDUFA), the FDA will have six months to review the data submission once they deem that our response is complete.
aIn conjunction with laViv, we are developing a personalized skin cream (proposed trade name Ua") that can be used as a complement to laViv or as a stand-alone product. We expect to launch it in the second half of 2011.
aAdditionally, we have submitted to the FDA a clinical study report for our Phase II/III study of laViv for the treatment of moderate to severe acne scars. As evidenced by the efficacy results achieved during the study, it is a promising potential indication for our therapy, and we look forward to initiating a discussion with the FDA concerning the validation of an evaluator assessment scale.
aOf great significance during the third quarter, we established a joint venture with Hefei Meifu Bio-Tech Limited Co. for developing and marketing autologous fibroblast therapies in Asia, excluding Japan. This is an important milestone in our international growth strategy, which is focused on creating a unique value proposition that currently does not exist in the market. The joint venture will allow us to capitalize on low manufacturing cost, integrated business cost, and a favorable location, as well as to establish distribution channels in central China.
aGoing forward, we will leverage our intellectual property and the expertise of our advisory board to drive innovation, capitalize on market opportunities for our proprietary technology, and to build value for our shareholders,a concluded Mr. Pernock.
About Fibrocell Science Technology
Fibroblasts are cells that contribute to the formation of connective tissue fibers, and regenerative fibroblast cells may have potential in use for broad aesthetic, medical and scientific applications.
Fibrocell Sciencea™s lead therapy, azficel-T, is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy to regenerate skin. Azficel-T is currently under review by the U.S. Food & Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles. Also, the Company recently submitted a clinical study report to the FDA for a Phase II/III trial of azficel-T in acne scarring.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (OTCBB: FCSC) is a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well its innovative cellular processing technology and manufacturing excellence. For additional information, please visit [ www.fibrocellscience.com ].
Forward-Looking Statements
All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company's control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2009, as updated in "Item 1A. Risk Factors" in the Company's Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company's public filings with the SEC.
| Fibrocell Science, Inc. | ||||||||||
| (A Development Stage Company) | ||||||||||
| Consolidated Successor Balance Sheets | ||||||||||
| (unaudited) | ||||||||||
| September 30, | December 31, | |||||||||
| 2010 | 2009 | |||||||||
Assets | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 205,083 | $ | 1,362,488 | ||||||
| Accounts receivable, net | 278,815 | 269,759 | ||||||||
| Inventory, net | 208,111 | 226,032 | ||||||||
| Prepaid expenses and other current assets | 562,957 | 525,024 | ||||||||
| Total current assets | 1,254,966 | 2,383,303 | ||||||||
| Property and equipment, net of accumulated depreciation of $5,612 and $0, respectively | 24,062 | a" | ||||||||
| Other assets | 250 | 250 | ||||||||
| Intangible assets | 6,340,656 | 6,340,656 | ||||||||
| Total assets | $ | 7,619,934 | $ | 8,724,209 | ||||||
| Liabilities, Redeemable Preferred Stock, Shareholders' Deficit and Noncontrolling Interest | ||||||||||
| Current liabilities: | ||||||||||
| Current debt | $ | a" | $ | 47,795 | ||||||
| Accounts payable | 1,073,376 | 245,023 | ||||||||
| Accrued expenses | 2,094,432 | 544,260 | ||||||||
| Total current liabilities | 3,167,808 | 837,078 | ||||||||
| Long-term debt | 6,000,060 | 6,000,060 | ||||||||
| Deferred tax liability | 2,500,000 | 2,500,000 | ||||||||
| Warrant liability | 4,653,838 | 635,276 | ||||||||
| Other long-term liabilities | 284,007 | 369,210 | ||||||||
| Total liabilities | 16,605,713 | 10,341,624 | ||||||||
| Commitments and contingencies | ||||||||||
| Preferred stock series A, $0.001 par value; 9,000 shares authorized; 3,250 shares issued and outstanding | 2,365,309 | 2,511,070 | ||||||||
| Preferred stock series B, $0.001 par value; 9,000 shares authorized; 2,977 shares issued and outstanding | 391,766 | a" | ||||||||
| Preferred stock series B, $0.001 par value; subscription receivable | -792,000 | a" | ||||||||
| Fibrocell Science, Inc. shareholders' deficit: | ||||||||||
| Successor common stock, $0.001 par value; 250,000,000 shares authorized | 19,769 | 14,692 | ||||||||
| Additional paid-in capital | 1,924,899 | 508,347 | ||||||||
| Accumulated deficit during development stage | -13,331,244 | -5,049,999 | ||||||||
| Total Fibrocell Science, Inc. shareholders' deficit | -11,386,576 | -4,526,960 | ||||||||
| Noncontrolling interest | 435,722 | 398,475 | ||||||||
| Total deficit and noncontrolling interest | -10,950,854 | -4,128,485 | ||||||||
| Total liabilities, preferred stock, shareholdersa™ deficit and noncontrolling interest | $ | 7,619,934 | $ | 8,724,209 | ||||||
| ||||||||||
| Fibrocell Science, Inc. | |||||||||||||||
| (A Development Stage Company) | |||||||||||||||
| Consolidated Statements of Operations | |||||||||||||||
| (unaudited) | |||||||||||||||
| Successor | Successor | Predecessor | |||||||||||||
| For the three months ended September 30, 2010 | For the one month ended September 30, 2009 | For the two months ended August 31, 2009 | |||||||||||||
| Revenue | |||||||||||||||
| Product sales | $ | 243,677 | $ | 75,029 | $ | 130,740 | |||||||||
| Total revenue | 243,677 | 75,029 | 130,740 | ||||||||||||
| Cost of sales | 118,916 | 53,323 | 252,420 | ||||||||||||
| Gross profit | 124,761 | 21,706 | -121,680 | ||||||||||||
| Selling, general and administrative expenses | 1,583,418 | 1,372,122 | 1,158,959 | ||||||||||||
| Research and development expenses | 1,387,466 | 556,242 | 614,511 | ||||||||||||
| Operating loss | -2,846,123 | -1,906,658 | -1,895,150 | ||||||||||||
| Other income (expense) | |||||||||||||||
| Interest income | a" | 1 | 1 | ||||||||||||
| Reorganization items, net | a" | a" | 74,132,188 | ||||||||||||
| Other expense | a" | a" | -6,243 | ||||||||||||
| Warrant income | 1,265,571 | a" | a" | ||||||||||||
| Interest expense | -211,919 | -58,333 | -290,063 | ||||||||||||
| |||||||||||||||
Income (loss) from continuing operations | -1,792,471 | -1,964,990 | 71,940,733 | ||||||||||||
| |||||||||||||||
Income (loss) from discontinued operations, net of tax | -8,575 | 5,799 | 216,203 | ||||||||||||
| Net income (loss) | -1,801,046 | -1,959,191 | 72,156,936 | ||||||||||||
| Net income (loss) attributable to noncontrolling interest | -20,859 | 1,644 | -214,292 | ||||||||||||
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Net income (loss) attributable to Fibrocell Science, Inc. common shareholders. | -1,821,905 | -$1,957,547 | $ | 71,942,644 | |||||||||||
| Per share information: | |||||||||||||||
| |||||||||||||||
Income (loss) from continuing operations-basic and diluted | -$0.09 | -$0.13 | $ | 1.85 | |||||||||||
| |||||||||||||||
Net income (loss) attributable to common shareholders per common sharea"basic and diluted | -$0.09 | -$0.13 | $ | 1.85 | |||||||||||
| |||||||||||||||
Weighted average number of basic and diluted common shares outstanding | 19,557,842 | 14,666,666 | 38,820,380 | ||||||||||||
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| Fibrocell Science, Inc. | ||||||||||||||||||||
| (A Development Stage Company) | ||||||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||||||
| (unaudited) | ||||||||||||||||||||
| Successor | Successor | Successor | Predecessor | Predecessor | ||||||||||||||||
| For the nine months ended September 30, 2010 | For the one month ended September 30, 2009 | Cumulative period from September 1, 2009 (date of inception) to September 30, 2010 | For the eight months ended August 31, 2009 | Cumulative period from December 28, 1995 (date of inception) to August 31, 2009 | ||||||||||||||||
| Revenue | ||||||||||||||||||||
| Product sales | $ | 716,809 | $ | 75,029 | $ | 1,046,750 | $ | 538,620 | $ | 4,818,994 | ||||||||||
| License fees | a" | a" | a" | a" | 260,000 | |||||||||||||||
| Total revenue | 716,809 | 75,029 | 1,046,750 | 538,620 | 5,078,994 | |||||||||||||||
| Cost of sales | 395,351 | 53,323 | 577,399 | 424,139 | 2,279,335 | |||||||||||||||
| Gross profit | 321,458 | 21,706 | 469,351 | 114,481 | 2,799,659 | |||||||||||||||
| Selling, general and administrative expenses | 5,424,661 | 1,372,122 | 8,133,017 | 3,427,374 | 84,805,520 | |||||||||||||||
| Research and development expenses | 4,053,817 | 556,242 | 5,877,013 | 2,107,718 | 56,269,869 | |||||||||||||||
| Operating loss | -9,157,020 | -1,906,658 | -13,540,679 | -5,420,611 | -138,275,730 | |||||||||||||||
| Other income (expense) | ||||||||||||||||||||
| Interest income | a" | 1 | 1 | 248 | 6,989,539 | |||||||||||||||
| Reorganization items, net | 3,303 | a" | -69,174 | 73,538,984 | 73,538,984 | |||||||||||||||
| Other income (expense) | a" | a" | a" | -6,243 | 316,338 | |||||||||||||||
| Warrant income | 1,560,757 | a" | 1,241,673 | a" | a" | |||||||||||||||
| Interest expense | -612,917 | -58,333 | -860,091 | -2,232,138 | -18,790,218 | |||||||||||||||
| ||||||||||||||||||||
Income (loss) from continuing operations before income taxes | -8,205,877 | -1,964,990 | -13,228,270 | 65,880,240 | -76,221,087 | |||||||||||||||
| Income tax benefit | a" | a" | a" | a" | 190,754 | |||||||||||||||
| ||||||||||||||||||||
Income (loss) from continuing operations | -8,205,877 | -1,964,990 | -13,228,270 | 65,880,240 | -76,030,333 | |||||||||||||||
| Income (loss) from discontinued operations | -38,121 | 5,799 | -50,234 | 46,923 | -41,091,311 | |||||||||||||||
| Net income (loss) | -8,243,998 | -1,959,191 | -13,278,504 | 65,927,163 | -117,121,644 | |||||||||||||||
| ||||||||||||||||||||
Deemed dividend associated with beneficial conversion | a" | a" | a" | a" | -11,423,824 | |||||||||||||||
| Preferred stock dividends | a" | a" | a" | a" | -1,589,861 | |||||||||||||||
| ||||||||||||||||||||
Net income/(loss) attributable to noncontrolling interest | -37,247 | 1,644 | -52,740 | -205,632 | 1,799,523 | |||||||||||||||
| ||||||||||||||||||||
Net income (loss) attributable to Fibrocell Science, Inc. common shareholders. | -$8,281,245 | -$1,957,547 | -$13,331,244 | $ | 65,721,531 | -$128,335,806 | ||||||||||||||
| Per share information: | ||||||||||||||||||||
| ||||||||||||||||||||
Income (loss) from continuing operations-basic and diluted | -$0.45 | -$0.13 | -$0.77 | $ | 1.72 | -$4.30 | ||||||||||||||
| Loss from discontinued operations-basic and diluted | a" | a" | a" | a" | -2.32 | |||||||||||||||
| Income attributable to noncontrolling interest | a" | a" | -0.01 | a" | 0.1 | |||||||||||||||
| Deemed dividend associated with beneficial conversion of preferred stock | a" | a" | a" | a" | -0.65 | |||||||||||||||
| Preferred stock dividends | a" | a" | a" | a" | -0.09 | |||||||||||||||
| ||||||||||||||||||||
Net income (loss) attributable to common shareholders per common sharea"basic and diluted | -$0.45 | -$0.13 | -$0.78 | $ | 1.72 | -$7.26 | ||||||||||||||
| ||||||||||||||||||||
Weighted average number of basic and diluted common shares outstanding | 18,291,301 | 14,666,666 | 17,104,057 | 38,230,886 | 17,678,219 | |||||||||||||||
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