Fibrocell Science, Inc. Reports First Quarter 2011 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 today a financial and business update for the first quarter ended March 31, 2011.
"In the first quarter, we continued to work closely with the FDA during the final review stage of azficel-T, proposed brand name laViv®, our personalized cell-based aesthetic treatment for severe nasolabial folds and wrinkles. We look forward to the upcoming Prescription Drug User Fee Act date on June 22, 2011."
Revenue was constant for the first quarter of 2011 and 2010 at $0.2 million. Net loss for the first quarter of 2011 was $17.1 million, compared to net loss of $4.7 million for the first quarter of 2010. The increase in the net loss for the first quarter 2011 is due primarily to the revaluation of the warrant liability and derivative liability associated with the outstanding warrants and preferred stock, respectively, that the Company has issued in its financing transactions.
David Pernock, Fibrocell Science Chairman and CEO, commented, aIn the first quarter, we continued to work closely with the FDA during the final review stage of azficel-T, proposed brand name laViv®, our personalized cell-based aesthetic treatment for severe nasolabial folds and wrinkles. We look forward to the upcoming Prescription Drug User Fee Act date on June 22, 2011.
aLooking forward, we plan to apply our autologous fibroblast technology to address unmet medical needs, such as the treatment of acne scars, restrictive burn scars and vocal cord scars. In the longer term, we believe that our scientific collaboration with University of California, Los Angeles positions us well for advancing our research efforts,a concluded Mr. Pernock.
James Byrne, Assistant Professor at the University of California, Los Angeles, added, "Our scientific collaboration with Fibrocell is based on two unique approaches. One approach involves using cells directly derived and purified from a patient's skin without requiring reprogramming. The other approach involves reprogramming purified adult human cells into a large library of induced pluripotent stem cell (iPSC) lines, screening them to identify fully reprogrammed iPSCs and then differentiating them into cells that we hope would be accepted by the immune system post autologous transplantation into patients."
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, 2010. 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) | ||||
Condensed Consolidated Balance Sheets | ||||
(unaudited) | ||||
March 31, | December 31, | |||
2011 | 2010 | |||
Assets | ||||
Current assets: | ||||
Cash and cash equivalents | $3,310,138 | $867,738 | ||
Accounts receivable, net | 172,339 | 229,891 | ||
Inventory, net | 299,201 | 258,939 | ||
Prepaid expenses and other current assets | 335,965 | 559,082 | ||
Total current assets | 4,117,643 | 1,915,650 | ||
Property and equipment, net of accumulated depreciation of $10,558 and $8,085, respectively | 36,607 | 21,589 | ||
Other assets | 250 | 250 | ||
Intangible assets | 6,340,656 | 6,340,656 | ||
Total assets | $10,495,156 | $8,278,145 | ||
Liabilities, Redeemable Preferred Stock, Shareholders' Deficit and Noncontrolling Interest | ||||
Current liabilities: | ||||
Current debt | $32,771 | $56,911 | ||
Accounts payable | 540,929 | 1,096,125 | ||
Accrued expenses | 751,422 | 789,482 | ||
Deferred revenue | 14,000 | a" | ||
Total current liabilities | 1,339,122 | 1,942,518 | ||
Long-term debt | 7,564,289 | 7,290,881 | ||
Deferred tax liability | 2,500,000 | 2,500,000 | ||
Warrant liability | 19,220,324 | 8,171,518 | ||
Derivative liability | 8,820,108 | 2,120,360 | ||
Other long-term liabilities | 227,205 | 255,606 | ||
Total liabilities | 39,671,048 | 22,280,883 | ||
Commitments and contingencies | ||||
Preferred stock series A, $0.001 par value; 9,000 shares authorized; 3,250 shares issued and 2,886 and 2,886 shares outstanding, respectively | 1,338,312 | 1,280,150 | ||
Preferred stock series B, $0.001 par value; 9,000 shares authorized; 4,640 shares issued and 2,693 and 4,640 shares outstanding, respectively | a" | a" | ||
Preferred stock series B, $0.001 par value; subscription receivable | a" | -210,000 | ||
Preferred stock series D, $0.001 par value; 8,000 shares authorized; 7,779 and 1,645 shares issued and outstanding, respectively | a" | a" | ||
Fibrocell Science, Inc. shareholders' deficit: | ||||
Successor common stock, $0.001 par value; 250,000,000 shares authorized; 24,559,097 and 20,375,500 shares issued and outstanding, respectively | 24,559 | 20,376 | ||
Additional paid-in capital | 4,055,108 | 2,437,893 | ||
Accumulated deficit during development stage | -35,063,900 | -17,981,530 | ||
Total Fibrocell Science, Inc. shareholders' deficit | -30,984,233 | -15,523,261 | ||
Noncontrolling interest | 470,029 | 450,373 | ||
Total deficit and noncontrolling interest | -30,514,204 | -15,072,888 | ||
Total liabilities, preferred stock, shareholdersa™ deficit and noncontrolling interest | $10,495,156 | $8,278,145 | ||
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Fibrocell Science, Inc. | ||||||||
(A Development Stage Company) | ||||||||
Condensed Consolidated Statements of Operations | ||||||||
(unaudited) | ||||||||
Successor | Successor | Successor | Predecessor | |||||
For the three | For the three | Cumulative period | Cumulative period | |||||
Revenue | ||||||||
Product sales | $208,636 | $209,070 | $1,474,946 | $4,818,994 | ||||
License fees | a" | a" | a" | 260,000 | ||||
Total revenue | 208,636 | 209,070 | 1,474,946 | 5,078,994 | ||||
Cost of sales | 97,858 | 100,519 | 782,554 | 2,279,335 | ||||
Gross profit | 110,778 | 108,551 | 692,392 | 2,799,659 | ||||
Selling, general and administrative expenses | 2,354,383 | 2,019,913 | 11,578,320 | 84,805,520 | ||||
Research and development expenses | 1,616,529 | 1,192,610 | 8,926,044 | 56,269,869 | ||||
Operating loss | -3,860,134 | -3,103,972 | -19,811,972 | -138,275,730 | ||||
Other income (expense) | ||||||||
Interest income | a" | a" | 1 | 6,989,539 | ||||
Reorganization items, net | a" | 3,303 | -69,174 | 73,538,984 | ||||
Other income | a" | a" | 244,479 | 316,338 | ||||
Warrant expense | -6,296,330 | -1,417,244 | -7,080,646 | a" | ||||
Derivative revaluation expense | -6,620,726 | a" | -6,620,726 | a" | ||||
Interest expense | -273,408 | -197,730 | -1,565,781 | -18,790,218 | ||||
Loss from continuing operations before income taxes | -17,050,598 | -4,715,643 | -34,903,819 | -76,221,087 | ||||
Income tax benefit | a" | a" | a" | 190,754 | ||||
Loss from continuing operations | -17,050,598 | -4,715,643 | -34,903,819 | -76,030,333 | ||||
Loss from discontinued operations | -12,116 | -17,044 | -73,034 | -41,091,311 | ||||
Net loss | -17,062,714 | -4,732,687 | -34,976,853 | -117,121,644 | ||||
Deemed dividend associated with beneficial conversion | a" | a" | a" | -11,423,824 | ||||
Preferred stock dividends | a" | a" | a" | -1,589,861 | ||||
Net (income)/loss attributable to noncontrolling interest | -19,656 | -15,138 | -87,047 | 1,799,523 | ||||
Net loss attributable to Fibrocell Science, Inc. common shareholders | -$17,082,370 | -$4,747,825 | -$35,063,900 | -$128,335,806 | ||||
Per share information: | ||||||||
Loss from continuing operations-basic and diluted | -$0.80 | -$0.30 | -$1.91 | -$4.30 | ||||
Loss from discontinued operations-basic and diluted | a" | a" | a" | -2.32 | ||||
Income (loss) attributable to noncontrolling interest | a" | a" | -0.01 | 0.10 | ||||
Deemed dividend associated with beneficial conversion of preferred stock | a" | a" | a" | -0.65 | ||||
Preferred stock dividends | a" | a" | a" | -0.09 | ||||
Net loss attributable to common shareholders per common sharea"basic and diluted | -$0.80 | -$0.30 | -$1.92 | -$7.26 | ||||
Weighted average number of basic and diluted common shares outstanding | 21,230,249 | 15,806,989 | 18,237,924 | 17,678,219 |