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 fiscal year ended December 31, 2010.
For the full fiscal year ended December 31, 2010, revenue was $936,369, compared to $868,561 for the same period a year ago. Net loss for the full fiscal year ended December 31, 2010 was $12,931,531, compared to net loss of $12,794,975 (excluding the reorganization gain of $73,466,507) for the same period last year.
“2010 was a very productive year for Fibrocell, culminating in the recent acceptance for review by the FDA of our complete response submission for azficel-T, proposed brand name laViv®,” commented David Pernock, Fibrocell Science Chairman and CEO. “If approved, it will be the first and only personalized cell-based aesthetic treatment of moderate to severe nasolabial folds and wrinkles. The Prescription Drug User Fee Act date is June 22, 2011, and we are working closely with the FDA during the final review stage.
“Based on our accomplishments year to date, we believe that 2011 is off to a very strong start. In a continuous effort to advance our cell therapy, we entered into a scientific collaboration with University of California, Los Angeles (UCLA) to research the conversion of dermal fibroblasts into pure functional human cell types that may have greater regenerative capacity. This research has the potential to result in future diagnostic or treatments based on each person’s own cells for illnesses such as Parkinson’s disease, diabetes and heart disease. To enable the process, we have accessed key patents from Stanford University.
“Additionally, as demonstrated by results of a five-patient pilot study which were published in The Laryngoscope journal, we have made good progress in evaluating the safety and effectiveness of autologous fibroblasts to treat vocal fold scarring. The study demonstrated that our autologous fibroblasts therapy helps improve voice by re-establishing normal mucosal pliability of the vocal folds.
“Looking towards the remainder of 2011, we will continue to forge our strategic scientific relationships, to capitalize on our intellectual property and to leverage our recently raised capital in order to proceed with our current studies as well as to apply our autologous fibroblast technology in additional aesthetic areas, such as the treatment of restrictive burn scars, acne scars, and periodontal disease,” 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 Science’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) | |||||||||
| Consolidated Balance Sheets | |||||||||
| December 31, 2010 | December 31, 2009 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 867,738 | $ | 1,362,488 | |||||
| Accounts receivable, net | 229,891 | 269,759 | |||||||
| Inventory, net | 258,939 | 226,032 | |||||||
| Prepaid expenses and other current assets | 559,082 | 525,024 | |||||||
| Total current assets | 1,915,650 | 2,383,303 | |||||||
| Property and equipment, net of accumulated depreciation of $8,085 and $0, respectively | 21,589 | — | |||||||
| Other assets | 250 | 250 | |||||||
| Intangible assets | 6,340,656 | 6,340,656 | |||||||
| Total assets | $ | 8,278,145 | $ | 8,724,209 | |||||
| Liabilities, Redeemable Preferred Stock, Shareholders' Deficit and Noncontrolling Interest | |||||||||
| Current liabilities: | |||||||||
| Current debt | $ | 56,911 | $ | 47,795 | |||||
| Accounts payable | 1,096,125 | 245,023 | |||||||
| Accrued expenses | 789,482 | 544,260 | |||||||
| Total current liabilities | 1,942,518 | 837,078 | |||||||
| Long-term debt | 7,290,881 | 6,000,060 | |||||||
| Deferred tax liability | 2,500,000 | 2,500,000 | |||||||
| Warrant liability | 8,171,518 | 635,276 | |||||||
| Derivative liability | 2,120,360 | — | |||||||
| Other long-term liabilities | 255,606 | 369,210 | |||||||
| Total liabilities | 22,280,883 | 10,341,624 | |||||||
| Commitments and contingencies | |||||||||
| Preferred stock series A, $0.001 par value; 9,000 shares authorized; 3,250 shares issued and 2,886 shares outstanding | 1,280,150 | 2,511,070 | |||||||
| Preferred stock series B, $0.001 par value; 9,000 shares authorized; 4,640 shares issued and outstanding | — | — | |||||||
| Preferred stock series B, $0.001 par value; subscription receivable |
(210,000 |
) |
— | ||||||
| Preferred stock series D, $0.001 par value; 8,000 shares authorized; 1,645 shares issued and outstanding | — | — | |||||||
| Fibrocell Science, Inc. shareholders' deficit: | |||||||||
| Successor common stock, $0.001 par value; 250,000,000 shares authorized; 20,375,500 issued and outstanding | 20,376 | 14,692 | |||||||
| Additional paid-in capital | 2,437,893 | 508,347 | |||||||
| Accumulated deficit during development stage |
(17,981,530 |
) |
(5,049,999 |
) |
|||||
| Total Fibrocell Science, Inc. shareholders' deficit |
(15,523,261 |
) |
(4,526,960 |
) |
|||||
| Noncontrolling interest | 450,373 | 398,475 | |||||||
| Total deficit and noncontrolling interest |
(15,072,888 |
) |
(4,128,485 |
) |
|||||
| Total liabilities, preferred stock, shareholders’ deficit and noncontrolling interest | $ | 8,278,145 | $ | 8,724,209 | |||||
| Fibrocell Science, Inc. | |||||||||||||||||||||
| (A Development Stage Company) | |||||||||||||||||||||
| Consolidated Statements of Operations | |||||||||||||||||||||
| Successor | Successor | Successor | Predecessor | Predecessor | |||||||||||||||||
|
For the year ended December 31, 2010 |
For the four months ended December 31, 2009 |
Cumulative period from September 1, 2009 (date of inception) to December 31, 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 | $ | 936,369 | $ | 329,941 | $ | 1,266,310 | $ | 538,620 | $ | 4,818,994 | |||||||||||
| License fees | — | — | — | — | 260,000 | ||||||||||||||||
| Total revenue | 936,369 | 329,941 | 1,266,310 | 538,620 | 5,078,994 | ||||||||||||||||
| Cost of sales | 502,648 | 182,048 | 684,696 | 424,139 | 2,279,335 | ||||||||||||||||
| Gross profit | 433,721 | 147,893 | 581,614 | 114,481 | 2,799,659 | ||||||||||||||||
| Selling, general and administrative expenses | 6,515,581 | 2,708,356 | 9,223,937 | 3,427,374 | 84,805,520 | ||||||||||||||||
| Research and development expenses | 5,486,319 | 1,823,196 | 7,309,515 | 2,107,718 | 56,269,869 | ||||||||||||||||
| Operating loss |
(11,568,179 |
) |
(4,383,659 |
) |
(15,951,838 |
) |
(5,420,611 |
) |
(138,275,730 |
) |
|||||||||||
| Other income (expense) | |||||||||||||||||||||
| Interest income | — | 1 | 1 | 248 | 6,989,539 | ||||||||||||||||
| Reorganization items, net | 3,303 |
(72,477 |
) |
(69,174 |
) |
73,538,984 | 73,538,984 | ||||||||||||||
| Other income (expense) | 244,479 | — | 244,479 |
(6,243 |
) |
316,338 | |||||||||||||||
| Warrant expense |
(465,232 |
) |
(319,084 |
) |
(784,316 |
) |
— | — | |||||||||||||
| Interest expense |
(1,045,199 |
) |
(247,174 |
) |
(1,292,373 |
) |
(2,232,138 |
) |
(18,790,218 |
) |
|||||||||||
|
|
|||||||||||||||||||||
|
Income (loss) from continuing operations before income taxes |
(12,830,828 |
) |
(5,022,393 |
) |
(17,853,221 |
) |
65,880,240 |
(76,221,087 |
) |
||||||||||||
| Income tax benefit | — | — | — | — | 190,754 | ||||||||||||||||
|
|
|||||||||||||||||||||
|
Income (loss) from continuing operations |
(12,830,828 |
) |
(5,022,393 |
) |
(17,853,221 |
) |
65,880,240 |
(76,030,333 |
) |
||||||||||||
| Income (loss) from discontinued operations |
(48,805 |
) |
(12,113 |
) |
(60,918 |
) |
46,923 |
(41,091,311 |
) |
||||||||||||
| Net income (loss) |
(12,879,633 |
) |
(5,034,506 |
) |
(17,914,139 |
) |
65,927,163 |
(117,121,644 |
) |
||||||||||||
|
|
|||||||||||||||||||||
|
Deemed dividend associated with beneficial conversion |
— | — | — | — |
(11,423,824 |
) |
|||||||||||||||
| Preferred stock dividends | — | — | — | — |
(1,589,861 |
) |
|||||||||||||||
|
|
|||||||||||||||||||||
|
Net (income)/loss attributable to noncontrolling interest |
(51,898 |
) |
(15,493 |
) |
(67,391 |
) |
(205,632 |
) |
1,799,523 | ||||||||||||
|
|
|||||||||||||||||||||
|
Net income (loss) attributable to Fibrocell Science, Inc. common shareholders |
($12,931,531 | ) | ($5,049,999 | ) | ($17,981,530 | ) | $ | 65,721,531 | ($128,335,806 | ) | |||||||||||
| Per share information: | |||||||||||||||||||||
|
Income (loss) from continuing operations-basic and diluted |
($0.68 | ) | ($0.35 | ) | ($1.01 | ) | $ | 1.72 | ($4.30 | ) | |||||||||||
|
Loss from discontinued operations-basic and diluted |
— | — | — | — |
(2.32 |
) |
|||||||||||||||
|
Income attributable to noncontrolling interest |
— |
— |
— |
— |
0.10 |
||||||||||||||||
|
Deemed dividend associated with beneficial conversion of preferred stock |
— | — | — | — |
(0.65 |
) |
|||||||||||||||
| Preferred stock dividends | — | — | — | — |
(0.09 |
) |
|||||||||||||||
|
Net income (loss) attributable to common shareholders per common share—basic and diluted |
($0.68 | ) | ($0.35 | ) | ($1.01 | ) | $ | 1.72 | ($7.26 | ) | |||||||||||
|
|
|||||||||||||||||||||
|
Weighted average number of basic and diluted common shares outstanding |
18,757,756 | 14,380,381 | 17,681,500 | 38,230,886 | 17,678,219 | ||||||||||||||||