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Table of Contents

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q
     
þ   Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended March 31, 2011
OR
     
o   Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Fibrocell Science, Inc.
(Exact name of registrant as specified in its Charter.)
         
Delaware
(State or other jurisdiction
  001-31564
(Commission File Number)
  87-0458888
(I.R.S. Employer
of incorporation)       Identification No.)
         
405 Eagleview Boulevard
Exton, Pennsylvania 19341

(Address of principal executive offices, including zip code)
(484) 713-6000
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant: (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for any shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
             
Large accelerated filer o   Accelerated filer o   Non-accelerated filer o   Smaller reporting company þ
        (Do not check if a smaller reporting company)    
Indicate by check mark whether the registrant is shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes þ No o
As of May 9, 2011, issuer had 30,911,561 shares issued and outstanding of common stock, par value $0.001.
 
 

 

 


 

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 Exhibit 31.1
 Exhibit 31.2
 Exhibit 32.1
 Exhibit 32.2

 

 


Table of Contents

PART I — FINANCIAL INFORMATION
ITEM 1.  
Financial statements.
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        
 
           
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
           
Preferred stock series B, $0.001 par value; subscription receivable
          (210,000 )
Preferred stock series D, $0.001 par value; 8,000 shares authorized; 7,779 and 1,645 shares issued and outstanding, respectively
           
 
               
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, shareholders’ deficit and noncontrolling interest
  $ 10,495,156     $ 8,278,145  
 
           
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

Fibrocell Science, Inc.
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(unaudited)
                                   
    Successor     Successor     Successor       Predecessor  
                    Cumulative period       Cumulative period  
                from September 1,       from December 28,  
    For the three     For the three     2009 (date of       1995 (date of  
    months ended     months ended     inception) to       inception) to  
    March 31, 2011     March 31, 2010     March 31, 2011       August 31, 2009  
Revenue
                                 
Product sales
  $ 208,636     $ 209,070     $ 1,474,946       $ 4,818,994  
License fees
                        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
                1         6,989,539  
Reorganization items, net
          3,303       (69,174 )       73,538,984  
Other income
                244,479         316,338  
Warrant expense
    (6,296,330 )     (1,417,244 )     (7,080,646 )        
Derivative revaluation expense
    (6,620,726 )           (6,620,726 )        
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
                        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
                        (11,423,824 )
Preferred stock dividends
                        (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
                        (2.32 )
Income (loss) attributable to noncontrolling interest
                (0.01 )       0.10  
Deemed dividend associated with beneficial conversion of preferred stock
                        (0.65 )
Preferred stock dividends
                        (0.09 )
 
                         
Net loss attributable to common shareholders per common share—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  
 
                         
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

Fibrocell Science, Inc.
(A Development Stage Company)
Condensed Consolidated Statements of Shareholders’ Equity (Deficit) and Comprehensive Income (Loss)
(unaudited)
                                                                                                 
                                                                                    Accumulated        
    Series A     Series B                                             Accumulated     Deficit     Total  
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During     Shareholders’  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income     Stage     (Deficit)  
Issuance of common stock for cash on 12/28/95
        $           $       2,285,291     $ 2,285     $ (1,465 )         $     $     $     $ 820  
Issuance of common stock for cash on 11/7/96
                            11,149       11       49,989                               50,000  
Issuance of common stock for cash on 11/29/96
                            2,230       2       9,998                               10,000  
Issuance of common stock for cash on 12/19/96
                            6,690       7       29,993                               30,000  
Issuance of common stock for cash on 12/26/96
                            11,148       11       49,989                               50,000  
Net loss
                                                                (270,468 )     (270,468 )
 
                                                                       
Balance, 12/31/96 (Predecessor)
        $           $       2,316,508     $ 2,316     $ 138,504           $     $     $ (270,468 )   $ (129,648 )
Issuance of common stock for cash on 12/27/97
                            21,182       21       94,979                               95,000  
Issuance of common stock for services on 9/1/97
                            11,148       11       36,249                               36,260  
Issuance of common stock for services on 12/28/97
                            287,193       287       9,968                               10,255  
Net loss
                                                                (52,550 )     (52,550 )
 
                                                                       
Balance, 12/31/97(Predecessor)
        $           $       2,636,031     $ 2,635     $ 279,700           $     $     $ (323,018 )   $ (40,683 )
The accompanying notes are an integral part of these consolidated financial statements.

 

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                                                                                    Accumulated        
    Series A     Series B                                             Accumulated     Deficit     Total  
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During     Shareholders’  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income     Stage     (Deficit)  
Issuance of common stock for cash on 8/23/98
        $           $       4,459     $ 4     $ 20,063           $     $     $     $ 20,067  
Repurchase of common stock on 9/29/98
                                              2,400       (50,280 )                 (50,280 )
Net loss
                                                                (195,675 )     (195,675 )
 
                                                                       
Balance, 12/31/98 (Predecessor)
        $           $       2,640,490     $ 2,639     $ 299,763       2,400     $ (50,280 )   $     $ (518,693 )   $ (266,571 )
Issuance of common stock for cash on 9/10/99
                            52,506       53       149,947                               150,000  
Net loss
                                                                (1,306,778 )     (1,306,778 )
 
                                                                       
Balance, 12/31/99 (Predecessor)
        $           $       2,692,996     $ 2,692     $ 449,710       2,400     $ (50,280 )   $     $ (1,825,471 )   $ (1,423,349 )
Issuance of common stock for cash on 1/18/00
                            53,583       54       1,869                               1,923  
Issuance of common stock for services on 3/1/00
                            68,698       69       (44 )                             25  
Issuance of common stock for services on 4/4/00
                            27,768       28       (18 )                             10  
Net loss
                                                                (807,076 )     (807,076 )
 
                                                                       
Balance, 12/31/00 (Predecessor)
        $           $       2,843,045     $ 2,843     $ 451,517       2,400     $ (50,280 )   $     $ (2,632,547 )   $ (2,228,467 )
The accompanying notes are an integral part of these consolidated financial statements.

 

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                                                                                    Accumulated        
    Series A     Series B                                             Accumulated     Deficit     Total  
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During     Shareholders’  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income     Stage     (Deficit)  
Issuance of common stock for services on 7/1/01
        $           $       156,960     $ 157     $ (101 )         $     $     $     $ 56  
Issuance of common stock for services on 7/1/01
                            125,000       125       (80 )                             45  
Issuance of common stock for capitalization of accrued salaries on 8/10/01
                            70,000       70       328,055                               328,125  
Issuance of common stock for conversion of convertible debt on 8/10/01
                            1,750,000       1,750       1,609,596                               1,611,346  
Issuance of common stock for conversion of convertible shareholder notes payable on 8/10/01
                            208,972       209       135,458                               135,667  
Issuance of common stock for bridge financing on 8/10/01
                            300,000       300       (192 )                             108  
Retirement of treasury stock on 8/10/01
                                        (50,280 )     (2,400 )     50,280                    
Issuance of common stock for net assets of Gemini on 8/10/01
                            3,942,400       3,942       (3,942 )                              
Issuance of common stock for net assets of AFH on 8/10/01
                            3,899,547       3,900       (3,900 )                              
Issuance of common stock for cash on 8/10/01
                            1,346,669       1,347       2,018,653                               2,020,000  
Transaction and fund raising expenses on 8/10/01
                                        (48,547 )                             (48,547 )
Issuance of common stock for services on 8/10/01
                            60,000       60                                     60  
Issuance of common stock for cash on 8/28/01
                            26,667       27       39,973                               40,000  
Issuance of common stock for services on 9/30/01
                            314,370       314       471,241                               471,555  
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

                                                                                                 
                                                                                    Accumulated        
    Series A     Series B                                             Accumulated     Deficit     Total  
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During     Shareholders’  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income     Stage     (Deficit)  
Uncompensated contribution of services—3rd quarter
        $           $           $     $ 55,556           $     $     $     $ 55,556  
Issuance of common stock for services on 11/1/01
                            145,933       146       218,754                               218,900  
Uncompensated contribution of services—4th quarter
                                        100,000                               100,000  
Net loss
                                                                (1,652,004 )     (1,652,004 )
 
                                                                       
Balance, 12/31/01 (Predecessor)
        $           $       15,189,563     $ 15,190     $ 5,321,761           $     $     $ (4,284,551 )   $ 1,052,400  
Uncompensated contribution of services—1st quarter
                                        100,000                               100,000  
Issuance of preferred stock for cash on 4/26/02
    905,000       905                               2,817,331                               2,818,236  
Issuance of preferred stock for cash on 5/16/02
    890,250       890                               2,772,239                               2,773,129  
Issuance of preferred stock for cash on 5/31/02
    795,000       795                               2,473,380                               2,474,175  
Issuance of preferred stock for cash on 6/28/02
    229,642       230                               712,991                               713,221  
Uncompensated contribution of services—2nd quarter
                                        100,000                               100,000  
Issuance of preferred stock for cash on 7/15/02
    75,108       75                               233,886                               233,961  
Issuance of common stock for cash on 8/1/02
                            38,400       38       57,562                               57,600  
Issuance of warrants for services on 9/06/02
                                        103,388                               103,388  
Uncompensated contribution of services—3rd quarter
                                        100,000                               100,000  
Uncompensated contribution of services—4th quarter
                                        100,000                               100,000  
Issuance of preferred stock for dividends
    143,507       144                               502,517                         (502,661 )      
Deemed dividend associated with beneficial conversion of preferred stock
                                        10,178,944                         (10,178,944 )      
Comprehensive income:
                                                                                               
Net loss
                                                                (5,433,055 )     (5,433,055 )
Other comprehensive income, foreign currency translation adjustment
                                                          13,875             13,875  
 
                                                                                             
Comprehensive loss
                                                                      (5,419,180 )
 
                                                                       
Balance, 12/31/02 (Predecessor)
    3,038,507     $ 3,039           $       15,227,963     $ 15,228     $ 25,573,999           $     $ 13,875     $ (20,399,211 )   $ 5,206,930  
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

                                                                                                 
                                                                                    Accumulated        
    Series A     Series B                                             Accumulated     Deficit     Total  
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During     Shareholders’  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income     Stage     (Deficit)  
Issuance of common stock for cash on 1/7/03
        $           $       61,600     $ 62     $ 92,338           $     $     $     $ 92,400  
Issuance of common stock for patent pending acquisition on 3/31/03
                            100,000       100       539,900                               540,000  
Cancellation of common stock on 3/31/03
                            (79,382 )     (79 )     (119,380 )                             (119,459 )
Uncompensated contribution of services—1st quarter
                                        100,000                               100,000  
Issuance of preferred stock for cash on 5/9/03
                110,250       110                   2,773,218                               2,773,328  
Issuance of preferred stock for cash on 5/16/03
                45,500       46                   1,145,704                               1,145,750  
Conversion of preferred stock into common stock—2nd qtr
    (70,954 )     (72 )                 147,062       147       40,626                               40,701  
Conversion of warrants into common stock—2nd qtr
                            114,598       114       (114 )                              
Uncompensated contribution of services—2nd quarter
                                        100,000                               100,000  
Issuance of preferred stock dividends
                                                                (1,087,200 )     (1,087,200 )
Deemed dividend associated with beneficial conversion of preferred stock
                                        1,244,880                         (1,244,880 )      
Issuance of common stock for cash—3rd qtr
                            202,500       202       309,798                               310,000  
Issuance of common stock for cash on 8/27/03
                            3,359,331       3,359       18,452,202                               18,455,561  
Conversion of preferred stock into common stock—3rd qtr
    (2,967,553 )     (2,967 )     (155,750 )     (156 )     7,188,793       7,189       (82,875 )                             (78,809 )
Conversion of warrants into common stock—3rd qtr
                            212,834       213       (213 )                              
Compensation expense on warrants issued to non-employees
                                        412,812                               412,812  
Issuance of common stock for cash—4th qtr
                            136,500       137       279,363                               279,500  
Conversion of warrants into common stock—4th qtr
                            393                                            
Comprehensive income:
                                                                                               
Net loss
                                                                (11,268,294 )     (11,268,294 )
Other comprehensive income, foreign currency translation adjustment
                                                          360,505             360,505  
 
                                                                                             
Comprehensive loss
                                                                      (10,907,789 )
 
                                                                       
Balance, 12/31/03 (Predecessor)
        $           $       26,672,192     $ 26,672     $ 50,862,258           $     $ 374,380     $ (33,999,585 )   $ 17,263,725  
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

                                                                                                 
                                                                                    Accumulated        
    Series A     Series B                                             Accumulated     Deficit     Total  
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During     Shareholders’  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income     Stage     (Deficit)  
Conversion of warrants into common stock—1st qtr
        $           $       78,526     $ 79     $ (79 )         $     $     $     $  
Issuance of common stock for cash in connection with exercise of stock options—1st qtr
                            15,000       15       94,985                               95,000  
Issuance of common stock for cash in connection with exercise of warrants—1st qtr
                            4,000       4       7,716                               7,720  
Compensation expense on options and warrants issued to non-employees and directors—1st qtr
                                        1,410,498                               1,410,498  
Issuance of common stock in connection with exercise of warrants—2nd qtr
                            51,828       52       (52 )                              
Issuance of common stock for cash—2nd qtr
                            7,200,000       7,200       56,810,234                               56,817,434  
Compensation expense on options and warrants issued to non-employees and directors—2nd qtr
                                        143,462                               143,462  
Issuance of common stock in connection with exercise of warrants—3rd qtr
                            7,431       7       (7 )                              
Issuance of common stock for cash in connection with exercise of stock options—3rd qtr
                            110,000       110       189,890                               190,000  
Issuance of common stock for cash in connection with exercise of warrants—3rd qtr
                            28,270       28       59,667                               59,695  
Compensation expense on options and warrants issued to non-employees and directors—3rd qtr
                                        229,133                               229,133  
Issuance of common stock in connection with exercise of warrants—4th qtr
                            27,652       28       (28 )                              
Compensation expense on options and warrants issued to non-employees, employees, and directors—4th qtr
                                        127,497                               127,497  
Purchase of treasury stock—4th qtr
                                              4,000,000       (25,974,000 )                 (25,974,000 )
Comprehensive income:
                                                                                               
Net loss
                                                                (21,474,469 )     (21,474,469 )
Other comprehensive income, foreign currency translation adjustment
                                                          79,725             79,725  
Other comprehensive income, net unrealized gain on available-for-sale investments
                                                          10,005             10,005  
 
                                                                                             
Comprehensive loss
                                                                      (21,384,739 )
 
                                                                       
Balance, 12/31/04 (Predecessor)
        $           $       34,194,899     $ 34,195     $ 109,935,174       4,000,000     $ (25,974,000 )   $ 464,110     $ (55,474,054 )   $ 28,985,425  
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

                                                                                                 
                                                                                    Accumulated        
    Series A     Series B                                             Accumulated     Deficit     Total  
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During     Shareholders’  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income (Loss)     Stage     (Deficit)  
Issuance of common stock for cash in connection with exercise of stock options—1st qtr
        $           $       25,000     $ 25     $ 74,975           $     $     $     $ 75,000  
Compensation expense on options and warrants issued to non-employees—1st qtr
                                        33,565                               33,565  
Conversion of warrants into common stock—2nd qtr
                            27,785       28       (28 )                              
Compensation expense on options and warrants issued to non-employees—2nd qtr
                                        (61,762 )                             (61,762 )
Compensation expense on options and warrants issued to non-employees—3rd qtr
                                        (137,187 )                             (137,187 )
Conversion of warrants into common stock—3rd qtr
                            12,605       12       (12 )                              
Compensation expense on options and warrants issued to non-employees—4th qtr
                                        18,844                               18,844  
Compensation expense on acceleration of options—4th qtr
                                        14,950                               14,950  
Compensation expense on restricted stock award issued to employee—4th qtr
                                        606                               606  
Conversion of predecessor company shares
                            94                                            
Comprehensive loss:
                                                                                               
Net loss
                                                                (35,777,584 )     (35,777,584 )
Other comprehensive loss, foreign currency translation adjustment
                                                          (1,372,600 )           (1,372,600 )
Foreign exchange gain on substantial liquidation of foreign entity
                                                                            133,851               133,851  
Other comprehensive loss, net unrealized gain on available-for-sale investments
                                                          (10,005 )           (10,005 )
 
                                                                                             
Comprehensive loss
                                                                      (37,026,338 )
 
                                                                       
Balance, 12/31/05 (Predecessor)
        $           $       34,260,383     $ 34,260     $ 109,879,125       4,000,000     $ (25,974,000 )   $ (784,644 )   $ (91,251,638 )   $ (8,096,897 )
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

                                                                                                         
                                                                                    Accumulated                
    Series A     Series B                                             Accumulated     Deficit             Total  
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During             Shareholders’  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Noncontrolling     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income     Stage     Interest     (Deficit)  
Compensation expense on options and warrants issued to non-employees—1st qtr
        $           $           $     $ 42,810           $     $     $     $     $ 42,810  
Compensation expense on option awards issued to employees and directors—1st qtr
                                        46,336                                     46,336  
Compensation expense on restricted stock issued to employees—1st qtr
                            128,750       129       23,368                                     23,497  
Compensation expense on options and warrants issued to non-employees—2nd qtr
                                        96,177                                     96,177  
Compensation expense on option awards issued to employees and directors—2nd qtr
                                        407,012                                     407,012  
Compensation expense on restricted stock to employees—2nd qtr
                                        4,210                                     4,210  
Cancellation of unvested restricted stock — 2nd qtr
                            (97,400 )     (97 )     97                                      
Issuance of common stock for cash in connection with exercise of stock options—2nd qtr
                            10,000       10       16,490                                     16,500  
Compensation expense on options and warrants issued to non-employees—3rd qtr
                                        25,627                                     25,627  
Compensation expense on option awards issued to employees and directors—3rd qtr
                                        389,458                                     389,458  
Compensation expense on restricted stock to employees—3rd qtr
                                        3,605                                     3,605  
Issuance of common stock for cash in connection with exercise of stock options—3rd qtr
                            76,000       76       156,824                                     156,900  
Acquisition of Agera
                                                                      2,182,505       2,182,505  
Compensation expense on options and warrants issued to non-employees—4th qtr
                                        34,772                                     34,772  
Compensation expense on option awards issued to employees and directors—4th qtr
                                        390,547                                     390,547  
Compensation expense on restricted stock to employees—4th qtr
                                        88                                     88  
Cancellation of unvested restricted stock award—4th qtr
                            (15,002 )     (15 )     15                                      
Comprehensive loss:
                                                                                                       
Net loss
                                                                (35,821,406 )     (78,132 )     (35,899,538 )
Other comprehensive gain, foreign currency translation adjustment
                                                          657,182                   657,182  
 
                                                                                                     
Comprehensive loss
                                                                            (35,242,356 )
 
                                                                             
Balance 12/31/06 (Predecessor)
        $           $       34,362,731     $ 34,363     $ 111,516,561       4,000,000     $ (25,974,000 )   $ (127,462 )   $ (127,073,044 )   $ 2,104,373     $ (39,519,209 )
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

                                                                                                         
                                                                                    Accumulated                
    Series A     Series B                                             Accumulated     Deficit             Total  
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During             Shareholders’  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Noncontrolling     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income (Loss)     Stage     Interest     (Deficit)  
Compensation expense on options and warrants issued to non-employees—1st qtr
        $           $           $     $ 39,742           $     $     $     $     $ 39,742  
Compensation expense on option awards issued to employees and directors—1st qtr
                                        448,067                                     448,067  
Compensation expense on restricted stock issued to employees—1st qtr
                                        88                                     88  
Issuance of common stock for cash in connection with exercise of stock options—1st qtr
                            15,000       15       23,085                                     23,100  
 
Expense in connection with modification of employee stock options —1st qtr
                                        1,178,483                                     1,178,483  
Compensation expense on options and warrants issued to non-employees—2nd qtr
                                        39,981                                     39,981  
Compensation expense on option awards issued to employees and directors—2nd qtr
                                        462,363                                     462,363  
Compensation expense on restricted stock issued to employees—2nd qtr
                                        88                                     88  
Compensation expense on option awards issued to employees and directors—3rd qtr
                                        478,795                                     478,795  
Compensation expense on restricted stock issued to employees—3rd qtr
                                        88                                     88  
Issuance of common stock upon exercise of warrants—3rd qtr
                            492,613       493       893,811                                     894,304  
Issuance of common stock for cash, net of offering costs—3rd qtr
                            6,767,647       6,767       13,745,400                                     13,752,167  
Issuance of common stock for cash in connection with exercise of stock options—3rd qtr
                            1,666       2       3,164                                     3,166  
Compensation expense on option awards issued to employees and directors—4thqtr
                                        378,827                                     378,827  
Compensation expense on restricted stock issued to employees—4thqtr
                                        88                                     88  
 
Comprehensive loss:
                                                                                                       
 
Net loss
                                                                (35,573,114 )     (246,347 )     (35,819,461 )
Other comprehensive gain, foreign currency translation adjustment
                                                          846,388                   846,388  
 
                                                                                                     
 
Comprehensive loss
                                                                            (34,973,073 )
 
                                                                             
 
Balance 12/31/07 (Predecessor)
        $           $       41,639,657     $ 41,640     $ 129,208,631       4,000,000     $ (25,974,000 )   $ 718,926     $ (162,646,158 )   $ 1,858,026     $ (56,792,935 )
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

                                                                                                         
                                                                                    Accumulated                
    Series A     Series B                                             Accumulated     Deficit             Total  
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During             Shareholders’  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Noncontrolling     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income (Loss)     Stage     Interest     (Deficit)  
Compensation expense on vested options related to non-employees—1st qtr
        $           $           $     $ 44,849           $     $     $     $     $ 44,849  
Compensation expense on option awards issued to employees and directors—1st qtr
                                        151,305                                     151,305  
Expense in connection with modification of employee stock options —1st qtr
                                        1,262,815                                     1,262,815  
 
Retirement of restricted stock
                            (165 )     (1 )                                         (1 )
Compensation expense on vested options related to non-employees—2nd qtr
                                        62,697                                     62,697  
Compensation expense on option awards issued to employees and directors—2nd qtr
                                        193,754                                     193,754  
Compensation expense on vested options related to non-employees—3rd qtr
                                        166,687                                     166,687  
Compensation expense on option awards issued to employees and directors—3rd qtr
                                        171,012                                     171,012  
Compensation expense on vested options related to non-employees—4th qtr
                                        (86,719 )                                   (86,719 )
Compensation expense on option awards issued to employees and directors—4th qtr
                                        166,196                                     166,196  
 
Comprehensive loss:
                                                                                                       
 
Net loss
                                                                (31,411,179 )     (1,680,676 )     (33,091,855 )
Reclassification of foreign exchange gain on substantial liquidation of foreign entities
                                                          (2,152,569 )                 (2,152,569 )
Other comprehensive gain, foreign currency translation adjustment
                                                          1,433,643                   1,433,643  
 
                                                                                                     
 
Comprehensive loss
                                                                            (33,810,781 )
 
                                                                             
 
Balance 12/31/08 (Predecessor)
        $           $       41,639,492     $ 41,639     $ 131,341,227       4,000,000     $ (25,974,000 )   $     $ (194,057,337 )   $ 177,350     $ (88,471,121 )
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

                                                                                                         
                                                                                    Accumulated                
    Series A     Series B                                             Accumulated     Deficit                
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During             Total  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Noncontrolling     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income (Loss)     Stage     Interest     (Deficit)  
Compensation expense on vested options related to non-employees—1st qtr
        $           $           $     $ 1,746           $     $     $     $     $ 1,746  
Compensation expense on option awards issued to employees and directors—1st qtr
                                        138,798                                     138,798  
Conversion of debt into common stock — 1st qtr 2009
                            37,564       38       343,962                                     344,000  
Compensation expense on option awards issued to employees and directors—2nd qtr
                                        112,616                                     112,616  
Conversion of debt into common stock — 2nd qtr 2009
                            1,143,324       1,143       10,468,857                                     10,470,000  
Compensation expense on option awards issued to employees and directors—2 months ended 8/31/09
                                        35,382                                     35,382  
Balance of expense due to cancellation of options issued to employees and directors in bankruptcy—2 months ended 8/31/09
                                        294,912                                     294,912  
 
Comprehensive income:
                                                                                                       
 
Net income
                                                                65,721,531       205,632       65,927,163  
 
                                                                                                     
 
Comprehensive income
                                                                            65,927,163  
 
                                                                             
 
Balance 8/31/09 (Predecessor)
                            42,820,380     $ 42,820     $ 142,737,500       4,000,000     $ (25,974,000 )   $     $ (128,335,806 )   $ 382,982     $ (11,146,504 )
Cancellation of Predecessor common stock and fresh start adjustments
                            (42,820,380 )     (42,820 )     (150,426,331 )     (4,000,000 )     25,974,000                         (124,495,151 )
Elimination of Predecessor accumulated deficit and accumulated other comprehensive loss
                                                                128,335,806             128,335,806  
 
                                                                             
 
Balance 9/1/09 (Predecessor)
                                        (7,688,831 )                             382,982       (7,305,849 )
Issuance of 11.4 million shares of common stock in connection with emergence from Chapter 11
                            11,400,000       11,400       5,460,600                                     5,472,000  
 
                                                                             
 
Balance 9/1/09 (Successor)
                            11,400,000       11,400       (2,228,231 )                             382,982       (1,833,849 )
Issuance of 2.7 million shares of common stock in connection with the exit financing
                            2,666,666       2,667       1,797,333                                     1,800,000  
Issuance of common stock on Oct. 28, 2009
                            25,501       25       58,627                                     58,652  
Compensation expense on shares issued to management
                            600,000       600       167,400                                     168,000  
Compensation expense on option awards issued to directors
                                        326,838                                     326,838  
Compensation expense on option awards issued to non-employees
                                        386,380                                     386,380  
 
Comprehensive loss:
                                                                                                       
 
Net loss
                                                                (5,049,999 )     15,493       (5,034,506 )
 
                                                                                                     
 
Comprehensive loss
                                                                            (5,034,506 )
 
                                                                             
 
Balance 12/31/09 (Successor)
        $           $       14,692,167     $ 14,692     $ 508,347           $     $     $ (5,049,999 )   $ 398,475     $ (4,128,485 )
The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

                                                                                                         
                                                                                    Accumulated                
    Series A     Series B                                             Accumulated     Deficit                
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During             Total  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Noncontrolling     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income (Loss)     Stage     Interest     (Deficit)  
Issuance of 5.1 million shares of common stock in March 2010, net of issuance costs of $338,100
        $           $       5,076,664     $ 5,077     $ 3,464,323           $     $     $     $     $ 3,469,400  
Warrant fair value associated with common shares issued in March 2010
                                        (2,890,711 )                                   (2,890,711 )
Compensation expense on shares issued to management — 1Q10
                                        18,000                                     18,000  
Compensation expense on option awards issued to directors/employees — 1Q10
                                        324,377                                     324,377  
Compensation expense on option awards issued to non-employees — 1Q10
                                        18,391                                     18,391  
Compensation expense on shares issued to management — 2Q10
                                        18,000                                     18,000  
Compensation expense on option awards issued to directors/employees — 2Q10
                                        222,011                                     222,011  
Compensation expense on option awards issued to non-employees — 2Q10
                                        33,206                                     33,206  
Compensation expense on shares issued to management — 3Q10
                                        18,000                                     18,000  
Compensation expense on option awards issued to directors/employees — 3Q10
                                        183,231                                     183,231  
Compensation expense on option awards issued to non-employees — 3Q10
                                        7,724                                     7,724  
Compensation expense on shares issued to management — 4Q10
                                        18,000                                     18,000  
Compensation expense on option awards issued to directors/employees — 4Q10
                                        104,094                                     104,094  
Compensation expense on option awards issued to non-employees — 4Q10
                                        27,507                                     27,507  
 
Preferred Stock Series A conversion
                            606,667       607       363,393                                     364,000  
 
Comprehensive loss:
                                                                                                       
 
Net loss
                                                                (12,931,531 )     51,898       (12,879,633 )
 
                                                                                                     
 
Comprehensive loss
                                                                            (12,879,633 )
 
                                                                             
 
Balance 12/31/10 (Successor)
        $           $       20,375,498     $ 20,376     $ 2,437,893           $     $     $ (17,981,530 )   $ 450,373     $ (15,072,888 )
 
                                                                             
The accompanying notes are an integral part of these consolidated financial statements.

 

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                                                                                    Accumulated                
    Series A     Series B                                             Accumulated     Deficit                
    Preferred Stock     Preferred Stock     Common Stock     Additional     Treasury Stock     Other     During             Total  
    Number of             Number of             Number of             Paid-In     Number of             Comprehensive     Development     Noncontrolling     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income (Loss)     Stage     Interest     (Deficit)  
Compensation expense on shares issued to management — 1Q11
                                        18,000                                     18,000  
Compensation expense on option awards issued to directors/employees — 1Q11
                                        995,551                                     995,551  
Compensation expense on option awards issued to non-employees — 1Q11
                                        38,203                                     38,203  
Preferred Stock and warrants exercised — 1Q11
                            289,599       289       241,542                                     241,831  
Preferred Stock Series A and B converted — 1Q11
                            3,894,000       3,894       323,919                                     327,813  
 
Comprehensive loss:
                                                                                                       
 
Net loss
                                                                (17,082,370 )     19,656       (17,062,714 )
 
                                                                                                     
 
Comprehensive loss
                                                                            (17,062,714 )
 
                                                                             
 
Balance 3/31/11 (Successor)
        $           $       24,559,097     $ 24,559     $ 4,055,108           $     $     $ (35,063,900 )   $ 470,029     $ (30,514,204 )
 
                                                                             
The accompanying notes are an integral part of these consolidated financial statements.

 

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Fibrocell Science, Inc.
(A Development Stage Company)
Condensed Consolidated Statements of Cash Flows
(unaudited)
                                   
    Successor     Successor     Successor       Predecessor  
                    Cumulative       Cumulative  
                    period from       period from  
                September 1,       December 31,  
    For the three     For the three     2009 (date of       1995 (date of  
    months ended     months ended     inception) to       inception) to  
    March 31, 2011     March 31, 2010     March 31, 2011       August 31, 2009  
Cash flows from operating activities:
                                 
Net loss
  $ (17,082,370 )   $ (4,747,825 )   $ (35,063,900 )     $ (115,322,121 )
Adjustments to reconcile net loss to net cash used in operating activities:
                                 
Reorganization items, net
                72,477         (74,648,976 )
Expense related to equity awards and issuance of stock
    1,051,754       360,768       2,925,513         10,608,999  
Warrant expense
    6,296,330       1,417,244       7,080,646          
Derivative revaluation expense
    6,620,726             6,620,726          
Uncompensated contribution of services
                        755,556  
Depreciation and amortization
    2,473       852       10,558         9,091,990  
Provision for doubtful accounts
    (8,372 )     (4,948 )     (62,809 )       337,810  
Provision for excessive and/or obsolete inventory
    5,387       (34,532 )     (43,315 )       259,427  
Amortization of debt issue costs
                        4,107,067  
Amortization of debt discounts on investments
                        (508,983 )
Loss on disposal or impairment of property and equipment
                        17,668,477  
Foreign exchange loss (gain) on substantial liquidation of foreign entity
    (859 )     2,448       (8,545 )       (2,256,408 )
Net (loss) income attributable to non-controlling interest
    19,656       15,138       87,047         (1,799,523 )
Change in operating assets and liabilities, excluding effects of acquisition:
                                 
Decrease (increase) in accounts receivable
    65,924       994       137,154         (91,496 )
Decrease (increase) in other receivables
    1,674       (88 )     2,381         218,978  
Decrease (increase) in inventory
    (45,649 )     818       12,733         (455,282 )
Decrease in prepaid expenses
    221,449       110,650       19,343         34,341  
Decrease in other assets
                4,120         71,000  
Increase (decrease) in accounts payable
    (555,196 )     (23,887 )     403,528         57,648  
Increase in accrued expenses, liabilities subject to compromise and other liabilities
    238,320       583,164       1,068,666         3,311,552  
Increase (decrease) in deferred revenue
    14,000             14,000         (50,096 )
 
                         
Net cash used in operating activities
    (3,154,753 )     (2,319,204 )     (16,719,677 )       (148,610,040 )
 
                         
Cash flows from investing activities:
                                 
Acquisition of Agera, net of cash acquired
                        (2,016,520 )
Purchase of property and equipment
    (17,491 )     (26,335 )     (47,165 )       (25,515,170 )
Proceeds from the sale of property and equipment, net of selling costs
                        6,542,434  
Purchase of investments
                        (152,998,313 )
Proceeds from sales and maturities of investments
                        153,507,000  
 
                         
Net cash used in investing activities
    (17,491 )     (26,335 )     (47,165 )       (20,480,569 )
 
                         
Cash flows from financing activities:
                                 
Proceeds from convertible debt
                        91,450,000  
Offering costs associated with the issuance of convertible debt
                        (3,746,193 )
Proceeds from notes payable to shareholders, net
                        135,667  
Proceeds from the issuance of redeemable preferred stock series A, net
                2,870,000         12,931,800  
Proceeds from the issuance of redeemable preferred stock series B, net
    193,200             4,212,770          
Proceeds from the issuance of redeemable preferred stock series D, net
    5,642,780             7,152,180          
Proceeds from the issuance of common stock, net
          3,469,400       5,269,400         93,753,857  
Costs associated with secured loan and debtor-in-possession loan
                        (360,872 )
Proceeds from secured loan
                        500,471  
Proceeds from debtor-in-possession loan
                        2,750,000  
Payments on insurance loan
    (24,139 )     (20,273 )     (109,713 )       (79,319 )
Cash dividends paid on preferred stock
    (198,227 )           (337,977 )       (1,087,200 )
Cash paid for fractional shares of preferred stock
                        (38,108 )
Merger and acquisition expenses
                        (48,547 )
Repurchase of common stock
                        (26,024,280 )
 
                         
Net cash provided by financing activities
    5,613,614       3,449,127       19,056,660         170,137,276  
 
                         
Effect of exchange rate changes on cash balances
    1,030       (2,631 )     10,044         (36,391 )
Net increase (decrease) in cash and cash equivalents
    2,442,400       1,100,957       2,299,862         1,010,276  
Cash and cash equivalents, beginning of period
    867,738       1,362,488       1,010,276          
 
                         
Cash and cash equivalents, end of period
  $ 3,310,138     $ 2,463,445     $ 3,310,138       $ 1,010,276  
 
                         
 
                                 
Supplemental disclosures of cash flow information:
                                 
Predecessor cash paid for interest
  $     $     $       $ 12,715,283  
 
                         
Successor cash paid for dividends
    198,227             337,977          
 
                         
                                   
Non-cash investing and financing activities:
                                 
Predecessor deemed dividend associated with beneficial conversion of preferred stock
  $     $     $       $ 11,423,824  
 
                         
Predecessor preferred stock dividend
                        1,589,861  
 
                         
Successor accrued preferred stock dividend
    197,582       48,260       197,582          
 
                         
Predecessor uncompensated contribution of services
                        755,556  
 
                         
Predecessor common stock issued for intangible assets
                        540,000  
 
                         
Predecessor common stock issued in connection with conversion of debt
                        10,814,000  
 
                         
Predecessor equipment acquired through capital lease
                        167,154  
 
                         
Successor/Predecessor financing of insurance premiums
                178,582         87,623  
 
                         
Successor issuance of notes payable
                        6,000,060  
 
                         
Successor common stock issued in connection with reorganization
                        5,472,000  
 
                         
Successor intangible assets
                        6,340,656  
 
                         
Successor deferred tax liability in connection with fresh-start
                        2,500,000  
 
                         
Elimination of Predecessor common stock and fresh start adjustment
                        14,780,320  
 
                         
Successor accrued warrant liability
    4,994,307       2,890,711       12,381,509          
 
                         
Successor conversion of preferred stock into common stock
    327,813             691,813          
 
                         
Exercise of warrants-cashless
    241,831             241,831          
 
                         
Successor accrued derivative liability
    510,810             2,631,170          
 
                         
The accompanying notes are an integral part of these consolidated financial statements.

 

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Fibrocell Science, Inc.
(A Development Stage Company)
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 1—Business and Organization
Fibrocell Science, Inc. (“Fibrocell” or the “Company” or the “Successor”) is the parent company of Fibrocell Technologies (“Fibrocell Tech”) and Agera Laboratories, Inc., a Delaware corporation (“Agera”). Fibrocell Technologies is the parent company of Isolagen Europe Limited, a company organized under the laws of the United Kingdom (“Isolagen Europe”), Isolagen Australia Pty Limited, a company organized under the laws of Australia (“Isolagen Australia”), and Isolagen International, S.A., a company organized under the laws of Switzerland (“Isolagen Switzerland”).
The Company is an aesthetic and therapeutic company focused on developing novel skin and tissue rejuvenation products. The Company’s clinical development product candidates are designed to improve the appearance of skin injured by the effects of aging, sun exposure, acne and burns with a patient’s own, or autologous, fibroblast cells produced in the Company’s proprietary Fibrocell Process. The Company also markets an advanced skin care line with broad application in core target markets through its Agera subsidiary.
Note 2—Development-Stage Risks and Liquidity
The Successor Company emerged from Bankruptcy in September 2009 and continues to operate as a going concern. At March 31, 2011, the Successor Company had cash and cash equivalents of approximately $3.3 million and working capital of $2.8 million.
As of May 9, 2011, the Company had cash and cash equivalents of approximately $2.0 million and current liabilities of approximately $1.1 million. The Company’s current monthly cash run-rate is approximately $1.0 million. The Company is in the process of purchasing manufacturing equipment and incurring marketing expenditures over the next couple of months to prepare the Company for launch post a possible FDA approval. Thus, the Successor Company will need to access the capital markets in the near future in order to fund future operations. There is no guarantee that any such required financing will be available on terms satisfactory to the Successor Company or available at all. These matters create uncertainty relating to its ability to continue as a going concern. The accompanying consolidated financial statements do not reflect any adjustments relating to the recoverability and classification of assets or liabilities that might result from the outcome of these uncertainties.
Further, if the Successor Company raises additional cash resources in the near future, it may be raised in contemplation of or in connection with bankruptcy. In the event of a bankruptcy, it is likely that its common stock and common stock equivalents will become worthless and our creditors will receive significantly less than what is owed to them.
Through March 31, 2011, the Successor Company has been primarily engaged in developing its initial product technology. In the course of its development activities, the Company has sustained losses and expects such losses to continue through at least 2011. During the quarter ended March 31, 2011, the Successor Company financed its operations primarily through its existing cash received from external financings, but as discussed above it now requires additional financing. There is substantial doubt about the Successor Company’s ability to continue as a going concern.
The Successor Company’s ability to complete additional offerings is dependent on the state of the debt and/or equity markets at the time of any proposed offering, and such market’s reception of the Successor Company and the offering terms. The Successor Company’s ability to complete an offering is also dependent on the status of its FDA regulatory milestones and its clinical trials, and in particular, the status of its indication for the treatment of nasolabial folds/wrinkles and the potential approval of the related BLA, which cannot be predicted. There is no assurance that capital in any form would be available to the Company, and if available, on terms and conditions that are acceptable.
As a result of the conditions discussed above, and in accordance with U.S. generally accepted accounting principles (GAAP), there exists substantial doubt about the Successor Company’s ability to continue as a going concern, and its ability to continue as a going concern is contingent, among other things, upon its ability to secure additional adequate financing or capital in the near future. If the Successor Company does not obtain additional funding, or does not anticipate additional funding, in the near future, it will likely enter into bankruptcy and/or cease operations. Further, if it does raise additional cash resources in the near future, it may be raised in contemplation of or in connection with bankruptcy. If the Successor Company enters into bankruptcy, it is likely that its common stock and common stock equivalents will become worthless and its creditors, including preferred stock holders, will receive significantly less than what is owed to them.

 

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Note 3—Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnote disclosures required by GAAP for complete consolidated financial statements. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation have been included. These financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010, filed with the Securities and Exchange Commission (SEC). The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or full year.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the consolidated financial statements and notes. In addition, management’s assessment of the Successor Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. Actual results may differ materially from those estimates.
Earnings (loss) per share data
Basic earnings (loss) per share is calculated based on the weighted average common shares outstanding during the period. Diluted earnings per share (“Diluted EPS’) also gives effect to the dilutive effect of stock options, warrants, restricted stock and convertible preferred stock calculated based on the treasury stock method.
The Predecessor and Successor Company’s potentially dilutive securities consist of potential common shares related to stock options, warrants, restricted stock and convertible preferred stock. Diluted EPS includes the impact of potentially dilutive securities except in periods in which there is a loss because the inclusion of the potential common shares would be anti-dilutive. The Company does not present diluted earnings per share for periods in which it incurred net losses as the effect is anti-dilutive.
Note 4—Agera Laboratories, Inc.
On August 10, 2006, the Predecessor Company acquired 57% of the outstanding common shares of Agera. Agera is a skincare company that has proprietary rights to a scientifically-based advanced line of skincare products. Agera markets its product primarily in the United States and Europe. The results of Agera’s operations and cash flows have been included in the consolidated financial statements from the date of the acquisition. The assets and liabilities of Agera have been included in the consolidated balance sheets since the date of the acquisition.

 

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Note 5—Fair Value Measurements
The Company adopted the accounting guidance on fair value measurements for financial assets and liabilities measured on a recurring basis. The guidance requires fair value measurements be classified and disclosed in one of the following three categories:
   
Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
   
Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability.
   
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liability measured at fair value on a recurring basis as of March 31, 2011 and December 31, 2010:
                                 
    Fair value measurement using  
            Significant     Significant        
    Quoted prices in     other     unobservable        
    active markets     observable     inputs        
    (Level 1)     inputs (Level 2)     (Level 3)     Total  
Balance at March 31, 2011
                               
Cash and cash equivalents
  $ 3,310,138     $     $     $ 3,310,138  
 
                       
 
                               
Liabilities
                               
Warrant liability
  $     $     $ 19,220,324     $ 19,220,324  
Derivative liability
                8,820,108       8,820,108  
 
                       
Total
  $     $     $ 28,040,432     $ 28,040,432  
 
                       
                                 
    Fair value measurement using  
            Significant     Significant        
    Quoted prices in     other     unobservable        
    active markets     observable     inputs        
    (Level 1)     inputs (Level 2)     (Level 3)     Total  
Balance at December 31, 2010
                               
Cash and cash equivalents
  $ 867,738     $     $     $ 867,738  
 
                       
 
                               
Liabilities
                               
Warrant liability
  $     $     $ 8,171,518     $ 8,171,518  
Derivative liability
                2,120,360       2,120,360  
 
                       
Total
  $     $     $ 10,291,878     $ 10,291,878  
 
                       
The reconciliation of warrant liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows:
         
    Warrant  
    Liability  
 
Balance at December 31, 2010
  $ 8,171,518  
 
Issuance of additional warrants
    4,994,307  
 
Exercise of warrants
    (241,831 )
 
Change in fair value of warrant liability
    6,296,330  
 
     
 
Balance at March 31, 2011
  $ 19,220,324  
 
     

 

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The fair value of the warrant liability is based on Level 3 inputs. For this liability, the Company developed its own assumptions that do not have observable inputs or available market data to support the fair value. See note 9 for further discussion of the warrant liability.
The reconciliation of derivative liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows:
         
    Derivative  
    Liability  
 
Balance at December 31, 2010
  $ 2,120,360  
 
Issuance of additional preferred stock
    510,810  
 
Conversion of preferred stock
    (431,788 )
 
Change in fair value of derivative liability
    6,620,726  
 
     
 
Balance at March 31, 2011
  $ 8,820,108  
 
     
The fair value of the derivative liability is based on Level 3 inputs. For this liability, the Company developed its own assumptions that do not have observable inputs or available market data to support the fair value. See note 8 for further discussion of the derivative liability.
Note 6—Accrued Expenses
Accrued expenses consist of the following:
                 
    March 31,     December 31,  
    2011     2010  
Accrued professional fees
  $ 393,392     $ 413,384  
Accrued compensation
    40,676       7,076  
Dividend on preferred stock payable
    190,772       191,417  
Accrued other
    126,582       177,605  
 
           
Accrued expenses
  $ 751,422     $ 789,482  
 
           
Note 7—Commitments and Contingencies
Legal Proceedings
As of March 31, 2011, there were no legal proceedings.
Note 8—Equity
Redeemable Preferred stock
As of March 31, 2011, the number of Redeemable Preferred stock (“Preferred”) outstanding, with a par value of $0.001 per share and a stated value of $1,000 per share is as follows:
         
Preferred Stock Series A
    2,886  
Preferred Stock Series B
    2,693  
Preferred Stock Series D
    7,779  
 
     
Total
    13,358  
 
     

 

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The Successor Company records accrued dividends at a rate of 6% per annum on the Series A, Series B and Series D Preferred. As of March 31, 2011, $190,772 was accrued for dividends payable. The Successor Company paid cash of $198,227 during the three months ended March 31, 2011.
Preferred Stock Series D
On January 21 and 28, February 9 and March 1, 2011, the Successor Company completed a private placement of securities of Series D Preferred and warrants. Each of the foregoing securities were subject to the “down-round” protection and if at any time while the Series D Preferred is outstanding, we sell or grant any option to purchase or sell or grant any right to reprice, or otherwise dispose of or issue (or announce any sale, grant or any option to purchase or other disposition), any common stock or common stock equivalents at an effective price per share that is lower than the then Conversion Price, then the Conversion Price will be reduced to equal the lower price. The preferred stock has been classified within the mezzanine section between liabilities and equity in its consolidated balance sheets in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) because any holder of Series D Preferred may require the Successor Company to redeem all of its Series D Preferred in the event of a triggering event which is outside of the control of the Successor Company.
The details of the Series D Preferred financing for the three months ended March 31, 2011 are as follows:
                 
    Number of shares of     Number of warrants  
Date of Financing   Series D Preferred (1)     issued (2)  
January 21, 2011
    1,234       2,665,440  
January 28, 2011
    1,414       3,054,240  
February 9, 2011
    3,436       7,421,760  
March 1, 2011
    50       108,000  
 
           
 
    6,134       13,249,440  
 
           
 
     
(1)  
Series D Preferred at a stated par value of $1,000.
 
(2)  
Warrants issued shares of Common Stock at an exercise price of $0.50 per share to certain accredited investors and placement agents.
Conversion option of Redeemable Preferred stock
The embedded conversion option for the Series A Preferred, Series B Preferred and Series D Preferred has been recorded as a derivative liability under ASC 815 in the consolidated balance sheet as of March 31, 2011 and December 31, 2010. As of March 31, 2011 the derivative liability was re-measured resulting in an expense of $6,620,726 in our statement of operations. The fair value of the derivative liability is determined using the Black-Scholes option pricing model and is affected by changes in inputs to that model including our stock price, expected stock price volatility, the contractual term, and the risk-free interest rate. The Company will continue to classify the fair value of the embedded conversion option as a liability and re-measure on the Company’s reporting dates until the preferred stock is converted into common stock.
The embedded conversion option for the Series A Preferred, Series B Preferred and Series D Preferred was valued at $8,820,108 at March 31, 2011 at fair value using the Black-Scholes option pricing model. The fair market value of the derivative liability was computed using the Black-Scholes option-pricing model with the following weighted average assumptions as of the dates indicated:
                 
    March 31, 2011     December 31, 2010  
Expected life (years)
  1.4 years     1.6 years  
Interest rate
    0.6 %     1.3 %
Dividend yield
           
Volatility
    62 %     63 %

 

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Note 9—Warrants
Preferred Stock Series D Warrants and Co-placement Agent Warrants
In connection with the Series D Convertible Preferred Stock transaction, the Successor Company issued 12,268,000 warrants at an exercise price of $0.50 per share and 981,440 placement agent warrants at an exercise price of $0.50 per share during the first quarter of 2011. The warrants are liability classified since they have “down-round” price protection and they are re-measured on the Company’s reporting dates. The weighted average fair market value of the warrants, at the date of issuance, granted to the accredited investors and co-placement agents, based on the Black-Scholes valuation model, is estimated to be $0.45 per warrant.
The fair market value of the warrants was computed using the Black-Scholes option-pricing model with the following key weighted average assumptions as of the dates indicated:
                 
    March 31, 2011     December 31, 2010  
Expected life (years)
  4.6 years     4.7 years  
Interest rate
    2.2 %     1.8 %
Dividend yield
           
Volatility
    62 %     63 %
   
The following table summarizes outstanding warrants to purchase Common Stock as of March 31, 2011:
                         
                    Warrant liability  
    Number of             Balance as of  
    Warrants     Expiration Dates   March 31, 2011  
Warrants and co-placement warrants issued in Series A Preferred Stock offering
    3,555,493     Oct. 2014   $ 1,484,193  
Warrants and co-placement warrants issued in March 2010 offering
    10,183,469     Mar. 2015     4,380,593  
Warrants and co-placement warrants issued in Series B Preferred Stock offering
    12,932,565     Jul.-Nov. 2015     5,774,963  
Warrants and co-placement warrants issued in Series D Preferred Stock offering
    16,802,640     Dec. 2015-Mar. 2016     7,580,575  
 
                   
Total
    43,474,167             $ 19,220,324  
 
                   
All warrants have an exercise price of $0.50 per share as a result of the December 2010 Preferred Stock Series D financing transaction. There were 953,568 warrants exercised on a cashless basis in the first quarter of 2011.
Note 10—Stock-based Compensation
Total stock-based compensation expense recognized using the straight-line attribution method in the consolidated statement of operations is as follows:
                 
    March 31,     March 31,  
    2011     2010  
Stock option compensation expense for employees and directors
  $ 995,551     $ 324,377  
Restricted stock expense
    18,000       18,000  
Equity awards for nonemployees issued for services
    38,203       18,391  
 
           
Total stock-based compensation expense
  $ 1,051,754     $ 360,768  
 
           

 

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                    Weighted-        
                    average        
            Weighted-     remaining        
            average     contractual     Aggregate  
    Number of     exercise     term (in     intrinsic  
    shares     price     years)     value  
 
Outstanding at December 31, 2010
    5,677,000     $ 0.86       7.46     $  
Granted
    5,008,000     $ 0.62                  
Exercised
        $                  
Forfeited
        $                  
 
                             
Outstanding at March 31, 2011
    10,685,000     $ 0.75       8.28     $ 694,960  
 
                       
 
                               
Exercisable at March 31, 2011
    6,379,720     $ 0.75       7.97     $ 330,380  
 
                       
The total fair value of shares vested during the three months ended March 31, 2011 was $1.0 million. As of March 31, 2011, there was $1.4 million of total unrecognized compensation cost, related to non-vested stock options which vest over time. That cost is expected to be recognized over a weighted-average period of 1.8 years. As of March 31, 2011, there was $0.3 million of total unrecognized compensation expense related to performance-based, non-vested employee and consultant stock options. That cost will be recognized when the performance criteria within the respective performance-based option grants become probable of achievement. As of March 31, 2011, there was no intrinsic value to the outstanding and exercisable options.
During the three months ended March 31, 2011 and 2010, the weighted average fair market value using the Black-Scholes option-pricing model of the options granted was $0.35 and $0.63, respectively, for this period. The fair market value of the warrants was computed using the Black-Scholes option-pricing model with the following key weighted average assumptions for the three months ended as of the dates indicated:
                 
    March 31, 2011     March 31, 2010  
Expected life (years)
  5.4 years     5.5 years  
Interest rate
    2.1 %     2.4 %
Dividend yield
           
Volatility
    62 %     65 %
There were no stock options exercised during the first quarter of March 31, 2011.
Restricted stock
As of March 31, 2011, there was less than $0.1 million of total unrecognized compensation cost related to non-vested restricted stock that is expected to be recognized over a weighted-average period less than 1 year.

 

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Note 11—Segment Information and Geographical information
The Successor Company has two reportable segments: Fibrocell Therapy and Agera. The Fibrocell Therapy segment specializes in the development and commercialization of autologous cellular therapies for soft tissue regeneration. The Agera segment maintains proprietary rights to a scientifically-based advanced line of skincare products. There is no intersegment revenue. The following table provides operating financial information for the continuing operations of the Successor Company’s two reportable segments:
                         
    Segment  
Three Months Ended March 31, 2011   Fibrocell Therapy     Agera     Consolidated  
Total operating revenue
  $     $ 208,636     $ 208,636  
 
                       
Segment income (loss) from continuing operations
  $ (17,072,010 )   $ 21,412     $ (17,050,598 )
 
                 
 
                       
Supplemental information related to continuing operations
                       
 
                       
Depreciation and amortization expense
  $ 2,473     $     $ 2,473  
Total assets, including assets from discontinued operations as of March 31, 2011
    9,859,336       635,820       10,495,156  
Property and equipment, net
    36,607             36,607  
Intangible assets, net
    6,340,656             6,340,656  
An intercompany receivable as of March 31, 2011, of $0.9 million, due from the Agera segment to the Fibrocell Therapy segment, is eliminated in consolidation. This intercompany receivable is primarily due to the intercompany management fee charge to Agera by Fibrocell Technologies, Inc., as well as Agera’s working capital needs provided by Fibrocell Technologies, Inc., and has been excluded from total assets of the Fibrocell Therapy segment in the above table. There is no intersegment revenue. Total assets on the consolidated balance sheet at March 31, 2011 are approximately $10.5 million, which includes assets of discontinued operations of less than $0.1 million.
                         
    Segment  
Three Months Ended March 31, 2010   Fibrocell Therapy     Agera     Consolidated  
Total operating revenue
  $     $ 209,070     $ 209,070  
 
                       
Segment income (loss) from continuing operations
  $ (4,726,548 )   $ 10,905     $ (4,715,643 )
 
                 
 
                       
Supplemental information related to continuing operations
                       
 
                       
Depreciation and amortization expense
  $ 852     $     $ 852  
Total assets, including assets from discontinued operations as of March 31, 2010
    9,094,140       683,610       9,777,750  
Property and equipment, net
    25,483             25,483  
Intangible assets, net
    6,340,656             6,340,656  
An intercompany receivable as of March 31, 2010, of $1.0 million, due from the Agera segment to the Fibrocell Therapy segment, is eliminated in consolidation. This intercompany receivable is primarily due to the intercompany management fee charge to Agera by Fibrocell Technologies, as well as Agera’s working capital needs provided by Fibrocell Technologies, and has been excluded from total assets of the Fibrocell Therapy segment in the above table. There is no intersegment revenue. Total assets on the consolidated balance sheet at March 31, 2010 are approximately $9.8 million.

 

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Geographical information concerning the Company’s revenue is as follows:
                 
    Three months ended     Three months ended  
    March 31, 2011     March 31, 2010  
United States
  $ 48,123     $ 60,194  
United Kingdom
    148,164       141,667  
Other
    12,349       7,209  
 
           
 
               
Total
  $ 208,636     $ 209,070  
 
           
During the three months ended March 31, 2011, revenue from one foreign customer and one domestic customer represented 71% and 16% of consolidated revenue, respectively. During the three months ended March 31, 2010, revenue from one foreign customer and one domestic customer represented 68% and 19% of consolidated revenue, respectively.
As of March 31, 2011 and December 31, 2010, one foreign customer represented 86% and 88%, respectively, of accounts receivable, net.
Note 12—Subsequent Events
Subsequent to March 31, 2011, 2,037 preferred shares were converted into 4,074,000 common shares and 2,536,967 warrants were exercised. Cash received for the warrants subsequent to March 31, 2011 was $739,984.

 

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Item 2.  
Management’s Discussion and Analysis of Financial Condition and Results of Operations
This report contains certain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, as well as information relating to Fibrocell that is based on management’s exercise of business judgment and assumptions made by and information currently available to management. When used in this document, the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “the facts suggest” and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect our current view of future events and are subject to certain risks and uncertainties as noted below. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, our actual results could differ materially from those anticipated in these forward-looking statements. Actual events, transactions and results may materially differ from the anticipated events, transactions or results described in such statements. Although we believe that our expectations are based on reasonable assumptions, we can give no assurance that our expectations will materialize. Many factors could cause actual results to differ materially from our forward looking statements. Several of these factors include, without limitation:
our ability to finance our business and continue in operations;
whether the results of our full Phase III pivotal study and our BLA filing will result in approval of our product candidate, and whether any approval will occur on a timely basis;
our ability to meet requisite regulations or receive regulatory approvals in the United States, Europe, Asia and the Americas, and our ability to retain any regulatory approvals that we may obtain; and the absence of adverse regulatory developments in the United States, Europe, Asia and the Americas or any other country where we plan to conduct commercial operations;
whether our clinical human trials relating to the use of autologous cellular therapy applications, and such other indications as we may identify and pursue can be conducted within the timeframe that we expect, whether such trials will yield positive results, or whether additional applications for the commercialization of autologous cellular therapy can be identified by us and advanced into human clinical trials;
our ability to develop autologous cellular therapies that have specific applications in cosmetic dermatology, and our ability to explore (and possibly develop) applications for periodontal disease, reconstructive dentistry, treatment of restrictive scars and burns and other health-related markets;
our ability to decrease our manufacturing costs for our Fibrocell Therapy product candidates through the improvement of our manufacturing process, and our ability to validate any such improvements with the relevant regulatory agencies;
our ability to reduce our need for fetal bovine calf serum by improved use of less expensive media combinations and different media alternatives;
continued availability of supplies at satisfactory prices;
new entrance of competitive products or further penetration of existing products in our markets;
the effect on us from adverse publicity related to our products or the company itself;
any adverse claims relating to our intellectual property;
the adoption of new, or changes in, accounting principles;
our issuance of certain rights to our shareholders that may have anti-takeover effects;
our dependence on physicians to correctly follow our established protocols for the safe administration of our Fibrocell Therapy; and
other risks referenced from time to time elsewhere in our filings with the SEC.

 

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These factors are not necessarily all of the important factors that could cause actual results of operations to differ materially from those expressed in these forward-looking statements. Other unknown or unpredictable factors also could have material adverse effects on our future results. We cannot assure you that projected results will be achieved.
General
We are an aesthetic and therapeutic development stage biotechnology company focused on developing novel skin and tissue rejuvenation products. Our clinical development product candidates are designed to improve the appearance of skin injured by the effects of aging, sun exposure, acne and burn scars with a patient’s own, or autologous, fibroblast cells produced by our proprietary Fibrocell Process. Our clinical development programs encompass both aesthetic and therapeutic indications. Our most advanced indication utilizing the Fibrocell Therapy is for the treatment of nasolabial folds/wrinkles, which completed Phase III clinical studies and the related Biologics License Application (“BLA”) was accepted for filing by the Food and Drug Administration (“FDA”) during May 2009. On October 9, 2009 the FDA Cellular, Tissue and Gene Therapies Advisory Committee reviewed our nasolabial folds/wrinkles product candidate. The Committee voted 11 “yes” to 3 “no” that the data presented on our product demonstrated efficacy, and 6 “yes” to 8 “no” that the data demonstrated safety; both for the proposed indication of treatment of nasolabial folds/wrinkles. The committee’s recommendations are not binding on the FDA, but the FDA will consider their recommendations during their review of our application. The United States Adopted Names (“USAN”) Council adopted the USAN name, azficel-T, for our product on October 28, 2009, and the FDA is currently evaluating a proposed brand name, laViv®. On December 21, 2009, Fibrocell Science received a Complete Response letter from the FDA related to the BLA for azficel-T. A Complete Response letter is issued by the FDA’s Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and additional data are needed prior to approval. The Complete Response letter requested that Fibrocell Science provide data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T. The letter also requested finalized Chemistry, Manufacturing and Controls (CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred during the BLA review period, as well as revised policies and procedures regarding shipping practices, and proposed labeling. The Company announced on December 20, 2010, that it had submitted its complete response to the Complete Response (CR) letter issued by the FDA regarding the Company’s BLA for azficel-T. On January 22, 2011, the FDA accepted for review the Company’s complete response submission for azficel-T. Even though the FDA has accepted the Company’s response for complete evaluation, there is no assurance that it will approve our product. The FDA, under the Prescription Drug User Fee Act (PDUFA), has a target six months review window to completely evaluate the Company’s response upon acceptance of the response. The PDUFA date is June 22, 2011. The Company announced on March 16, 2011, that it had submitted a final study report to the FDA for the completed, six-month histological study examining skin after injections of azficel-T.
During 2009 we completed a Phase II/III study for the treatment of acne scars. During 2008 we completed our open-label Phase II study related to full face rejuvenation.
We also develop and market an advanced skin care product line through our Agera subsidiary, in which we acquired a 57% interest in August 2006.
Critical Accounting Policies and Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make significant judgments and estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Management bases these significant judgments and estimates on historical experience and other assumptions it believes to be reasonable based upon information presently available. Actual results could differ from those estimates under different assumptions, judgments or conditions. There were no material changes to our critical accounting policies and use of estimates previously disclosed in our 2010 Annual Report on Form 10-K.

 

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Results of Operations
Three Months Ended March 31, 2011 compared to the Three Months Ended March 31, 2010
Revenues and Cost of Sales. Revenue and cost of sales for the three months ended March 31, 2011 and 2010 were comprised of the following:
                                 
    Three months ended     Increase  
    March 31,     (Decrease)  
    2011     2010     $     %  
    (in thousands)                  
Total revenue
  $ 209     $ 209     $       %
 
                               
Cost of sales
    98       100       (2 )     (2 %)
 
                       
 
                               
Gross profit
  $ 111     $ 109     $ (2 )     (2 %)
 
                       
The revenue and cost of sales for Agera remained flat comparing the three months ended March 31, 2011 and 2010. Our revenue from continuing operations is from the operations of Agera which we acquired on August 10, 2006. Agera markets and sells a complete line of advanced skin care systems based on a wide array of proprietary formulations, trademarks and peptide technology. As a percentage of revenue, Agera cost of sales were approximately 47% for the three months ended March 31, 2011 and 48% for the three months ended March 31, 2010.
Selling General and Administrative Expense. Selling, general and administrative expense for the three months ended March 31, 2011 and 2010 were comprised of the following:
                                 
    Three months ended     Increase  
    March 31,     (Decrease)  
    2011     2010     $     %  
    (in thousands)                  
Compensation and related expense
  $ 1,264     $ 951     $ 313       33 %
External services — consulting
    236       237       (1 )     (— %)
Facilities and related expense and other
    854       832       22       3 %
 
                       
 
                               
Total selling, general and administrative expense
  $ 2,354     $ 2,020     $ 334       17 %
 
                       
Selling, general and administrative expense increased primarily due to an increase in compensation and related expense related to an increase of $0.6 million for stock compensation expense offset by a decrease of $0.3 million in payroll expenses, due primarily to no bonuses accrued in 2011 and decreased payroll taxes.

 

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Research and Development Expense. Research and development expense for the three months ended March 31, 2011 and 2010 were comprised of the following:
                                 
    Three months ended     Increase  
    March 31,     (Decrease)  
    2011     2010     $     %  
    (in thousands)                  
Compensation and related expense
  $ 524     $ 364     $ 160       44 %
External services — consulting
    622       397       225       57 %
Lab costs and related expense
    277       223       54       24 %
Facilities and related expense
    194       209       (15 )     (7 %)
 
                       
 
                               
Total research and development expense
  $ 1,617     $ 1,193     $ 424       36 %
 
                       
Research and development expense increased primarily due to an increase in compensation and related expense related to an increase of $0.1 million for stock compensation expense, $0.1 million for increase headcount and $0.2 million for increased consulting fees. The increase of $0.2 million for external services related primarily to the histology study. Research and development costs are composed primarily of costs related to our efforts to gain FDA approval for our Fibrocell Therapy for specific dermal applications in the United States, as well as costs related to other potential indications for our Fibrocell Therapy, such as acne scars and burn scars. Also, research and development expense includes costs to develop manufacturing, cell collection and logistical process improvements. Research and development costs primarily include personnel and laboratory costs related to these FDA trials and certain consulting costs. The total inception (December 28, 1995) to date cost of research and development as of August 31, 2009 for the Predecessor Company was $56.3 million and total inception (September 1, 2009) to date cost of research and development as of March 31, 2011, for the Successor Company was $8.9 million.
The FDA approval process is extremely complicated and is dependent upon our study protocols and the results of our studies. In the event that the FDA requires additional studies for our product candidate or requires changes in our study protocols or in the event that the results of the studies are not consistent with our expectations, the process will be more expensive and time consuming. Due to the complexities of the FDA approval process, we are unable to predict what the cost of obtaining approval for our dermal product candidate will be.
Interest Income (Expense). Interest expense for the three months ended March 31, 2011 increased by $0.1 million, or 38%, from the three months ended March 31, 2010 due to higher debt balances. Our interest expense is related to the notes we issued in connection with our bankruptcy plan. We have been accreting the interest to principal at the rate of 15% per annum due to contractual terms.
Change in Revaluation of Warrant and Derivative Liability. During the three months ended March 31, 2011, we recorded a non-cash expense of $6.3 million and $6.6 million for warrant expense and derivative revaluation expense, respectively, in our statements of operations due to an increase in the fair value of the warrant liability and derivative liability related to the preferred stock series A, B and D financing. This increase in fair value was primarily due to an increase in the price per share of our common stock on March 31, 2011 as compared to December 31, 2010. During the three months ended March 31, 2010, we recorded a non-cash expense of $1.4 million for warrant expense in our statements of operations due to an increase in the fair value of the warrant liability for warrants to purchase preferred stock that were liability-classified.
Net loss attributable to common shareholders. Net loss attributable to common shareholders decreased approximately $12.3 million to a net loss of $17.1 million for the three months ended March 31, 2011, as compared to a net loss of $4.7 million for the three months ended March 31, 2010 primarily due to an increase in the fair value of the warrant liability and derivative liability related to the preferred stock series A, B and D financing.

 

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Liquidity and Capital Resources
The following table summarizes our cash flows from operating, investing and financing activities for the three months ended March 31, 2011 and 2010:
                 
    Three Months Ended March 31,  
    2011     2010  
    (in thousands)  
Statement of Cash Flows Data:
               
Total cash provided by (used in):
               
Operating activities
  $ (3,155 )   $ (2,319 )
Investing activities
    (17 )     (26 )
Financing activities
    5,613       3,449  
Operating Activities. Cash used in operating activities during the three months ended March 31, 2011 amounted to $3.1 million, an increase of $0.8 million over the three months ended March 31, 2010. The increase in our cash used in operating activities over the prior year is primarily due to an increase in net losses (adjusted for non-cash items) of $0.1 million, in addition to operating cash outflows from changes in operating assets and liabilities.
Investing Activities. Minimal or no cash was used in investing activities during the three months ended March 31, 2011 and during the three months ended March 31, 2010.
Financing Activities. There were $5.6 million cash proceeds from financing activities during the three months ended March 31, 2011, as compared to $3.4 million received from financing activities during the three months ended March 31, 2010. During the three months ended March 31, 2011, we raised cash from the issuance of preferred stock and warrants. During the three months ended March 31, 2010, we raised cash from the issuance of common stock and warrants.
Working Capital
As of March 31, 2011, we had cash and cash equivalents of $3.3 million and working capital of $2.8 million. The Company has raised approximately $6.1 million less fees as the result of the issuance of Series D Preferred Stock and warrants in the period from January 1, 2011 through March 1, 2011. As of May 9, 2011, the Company had cash and cash equivalents of approximately $2.0 million and current liabilities of approximately $1.1 million. The Company’s current monthly cash run-rate is approximately $1.0 million. The Company is in the process of purchasing manufacturing equipment and incurring marketing expenditures over the next couple of months to prepare the Company for launch post a possible FDA approval. Thus, the Company will need to access the capital markets in the near future in order to fund future operations. There is no guarantee that any such required financing will be available on terms satisfactory to the Company or available at all. These matters create uncertainty relating to its ability to continue as a going concern. The accompanying consolidated financial statements do not reflect any adjustments relating to the recoverability and classification of assets or liabilities that might result from the outcome of these uncertainties.
Debt
The Company’s outstanding long-term debt at March 31, 2011 and December 31, 2010 consists of $7.6 million and $7.3 million, respectively, of Unsecured Promissory Notes (“New Notes”). Unpaid interest has been accreted to the principal at a rate of 15%. The New Notes have the following features: (1) 12.5% interest payable quarterly in cash or, at the Company’s option, 15% payable in kind by capitalizing such unpaid amount and adding it to the principal as of the date it was due; (2) maturing June 1, 2012; (3) at any time prior to the maturity date, the Company may redeem any portion of the outstanding principal of the New Notes in Cash at 125% of the stated face value of the New Notes. There is a mandatory redemption feature that requires the Company to redeem all outstanding new notes if: (1) the Company successfully completes a capital campaign raising in excess of $10 million during a six month period; or (2) the Successor Company is acquired by, or sell a majority stake to, an outside party.

 

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Item 3.  
Quantitative and Qualitative Disclosures About Market Risk.
Market risk is the potential loss arising from adverse changes in market rates and prices, such as foreign currency exchange rates or interest rates.
Foreign Exchange Rate Risk
We do not believe that we have significant foreign exchange rate risk at March 31, 2011.
We do not enter into derivatives or other financial instruments for trading or speculative purposes.
Item 4.  
Controls and Procedures.
Evaluation of Disclosure Controls and Procedures and Changes in Internal Control over Financial Reporting
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of 1934, as amended (the Exchange Act)) as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms. We believe that a control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION
Item 1.  
Legal Proceedings.
None
Item 1A.  
Risk Factors.
There were no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K filed on March 30, 2011.
Item 2.  
Unregistered Sales of Equity Securities and Use of Proceeds
All information regarding the financings we completed during the three months ended March 31, 2011, have been previously disclosed in current reports we have filed on Form 8-K.
Item 3.  
Defaults Upon Senior Securities.
None
Item 4.  
(Removed and Reserved)
Item 5.  
Other Information.
None
Item 6.  
Exhibits
(a) Exhibits
     
EXHIBIT NO.   IDENTIFICATION OF EXHIBIT
   
 
*31.1  
Certification pursuant to Rule 13a-14(a) and 15d-14(a), required under Section 302 of the Sarbanes-Oxley Act of 2002
*31.2  
Certification pursuant to Rule 13a-14(a) and 15d-14(a), required under Section 302 of the Sarbanes-Oxley Act of 2002
*32.1  
Certification pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
*32.2  
Certification pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
     
*  
-Filed herewith

 

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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
         
  Fibrocell Science, Inc.
 
 
  By:   /s/ Declan Daly    
    Declan Daly   
    Chief Financial Officer   
Date: May 13, 2011

 

33