Fibrocell Science, Inc. Reports Full Year 2010 Financial Results and Provides Business Update

EXTON, Pa.--()--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  

Contacts

Fibrocell Science, Inc.
David M. Pernock
President & CEO
(484) 713-6000
davidpernock@fibrocellscience.com
or
ICR, LLC
Sherry Bertner
Managing Director
(646) 277-1247
Sherry.Bertner@icrinc.com

Contacts

Fibrocell Science, Inc.
David M. Pernock
President & CEO
(484) 713-6000
davidpernock@fibrocellscience.com
or
ICR, LLC
Sherry Bertner
Managing Director
(646) 277-1247
Sherry.Bertner@icrinc.com