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 June 30, 2008
OR
     
o   Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Isolagen, Inc.
(Exact name of registrant as specified in its charter)
         
Delaware   001-31564   87-0458888
(State or other jurisdiction   (Commission File Number)   (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) has 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. þ Yes o No
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 definition of “accelerated filer, “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
             
Large accelerated filer o   Accelerated filer þ   Non-accelerated filer o   Smaller reporting company o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes þ No
As of July 30, 2008, issuer had 41,639,492 shares of issued and 37,639,492 shares outstanding common stock, par value $0.001.
 
 

 

 


 

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Item 1. Financial Statements
       
 
       
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  Exhibit 31.1
  Exhibit 31.2
  Exhibit 32.1
  Exhibit 32.2

 

 


Table of Contents

PART I — FINANCIAL INFORMATION
Isolagen, Inc.
(A Development Stage Company)
Consolidated Balance Sheets
                 
    June 30     December 31,  
    2008     2007  
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 11,251,424     $ 16,590,720  
Restricted cash
          451,382  
Accounts receivable, net
    301,144       319,674  
Inventory, net
    594,644       669,119  
Other receivables
    143,334       29,250  
Prepaid expenses
    527,752       701,214  
Current assets of discontinued operations, net
    52,519       14,515  
 
           
Total current assets
    12,870,817       18,775,874  
 
           
Property and equipment, net of accumulated depreciation and amortization of $3,458,996 and $2,921,651, respectively
    2,858,108       3,395,723  
Intangibles, net of amortization of $886,119 and $718,762 , respectively
    4,432,181       4,599,538  
Other assets, net of amortization of $2,747,208 and $2,372,589, respectively
    1,049,849       1,424,456  
Assets of discontinued operations held for sale (see Note 3)
          11,202,725  
Other long-term assets of discontinued operations
    92,786       92,874  
 
           
Total assets
  $ 21,303,741     $ 39,491,190  
 
           
 
               
Liabilities, Minority Interests and Shareholders’ Deficit
               
Current liabilities:
               
Accounts payable
  $ 704,807     $ 403,815  
Accrued expenses
    3,113,073       4,348,256  
Current liabilities of discontinued operations
    430,790       217,822  
 
           
Total current liabilities
    4,248,670       4,969,893  
Long term debt
    90,000,000       90,000,000  
Other long term liabilities of continuing operations
    1,228,440       1,206,721  
Long term liabilities of discontinued operations
    71,491       107,511  
 
           
Total liabilities
    95,548,601       96,284,125  
 
           
Commitments and contingencies (see Note 7)
               
Minority interests
    1,797,531       1,858,026  
 
           
 
               
Shareholders’ deficit:
               
Preferred stock, $.001 par value; 5,000,000 shares authorized
           
Series C junior participating preferred stock, $.001 par value; 10,000 shares authorized
           
Common stock, $.001 par value; 100,000,000 shares authorized
    41,639       41,640  
Additional paid-in capital
    130,924,051       129,208,631  
Treasury stock, at cost, 4,000,000 shares
    (25,974,000 )     (25,974,000 )
Accumulated other comprehensive (loss) income
    (24,596 )     718,926  
Accumulated deficit during development stage
    (181,009,485 )     (162,646,158 )
 
           
Total shareholders’ deficit
    (76,042,391 )     (58,650,961 )
 
           
Total liabilities, minority interests and shareholders’ deficit
  $ 21,303,741     $ 39,491,190  
 
           
The accompanying notes are an integral part of these consolidated financial statements.

 

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Isolagen, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
(Unaudited)
                 
    Three Months Ended  
    June 30,  
    2008     2007  
Revenue
               
Product sales
  $ 271,721     $ 346,716  
License fees
           
 
           
Total revenue
    271,721       346,716  
Cost of sales
    147,787       157,373  
 
           
Gross profit
    123,934       189,343  
 
               
Selling, general and administrative expenses
    2,211,562       5,706,525  
Research and development
    3,251,355       3,372,032  
 
           
Operating loss
    (5,338,983 )     (8,889,214 )
Other income (expense)
               
Interest income
    46,886       234,932  
Other income
          65,137  
Interest expense
    (974,810 )     (974,810 )
Minority interest
    21,910       142,047  
 
           
 
               
Loss from continuing operations
    (6,244,997 )     (9,421,908 )
Loss from discontinued operations, net of tax (see Notes 3 and 5)
    (153,408 )     (318,952 )
 
           
Net loss
  $ (6,398,405 )   $ (9,740,860 )
 
           
 
               
Per share information:
               
Loss from continuing operations—basic and diluted
  $ (0.17 )   $ (0.31 )
Loss from discontinued operations—basic and diluted
    (0.00 )     (0.01 )
Deemed dividend associated with beneficial conversion of preferred stock
           
Preferred stock dividends
           
 
           
 
               
Net loss per common share—basic and diluted
  $ (0.17 )   $ (0.32 )
 
           
Weighted average number of basic and diluted common shares outstanding
    37,639,492       30,377,439  
 
           
The accompanying notes are an integral part of these consolidated financial statements.

 

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Isolagen, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
(Unaudited)
                         
                    Cumulative  
                    Period from  
                    December 28,  
                    1995 (date of  
    Six Months Ended     inception) to  
    June 30,     June 30,  
    2008     2007     2008  
Revenue
                       
Product sales
  $ 489,674     $ 660,338     $ 3,665,163  
License fees
                260,000  
 
                 
Total revenue
    489,674       660,338       3,925,163  
Cost of sales
    318,762       316,460       1,571,447  
 
                 
Gross profit
    170,912       343,878       2,353,716  
 
                       
Selling, general and administrative expenses
    6,156,400       12,043,830       72,302,485  
Research and development
    6,145,211       6,461,103       50,134,245  
 
                 
Operating loss
    (12,130,699 )     (18,161,055 )     (120,083,014 )
Other income (expense)
                       
Interest income
    133,518       533,682       6,941,295  
Other income
          65,137       322,581  
Interest expense
    (1,949,620 )     (1,949,620 )     (14,608,461 )
Minority interest
    60,495       241,481       384,974  
 
                 
Loss from continuing operations before income taxes
    (13,886,306 )     (19,270,375 )     (127,042,625 )
Income tax benefit
                190,754  
 
                 
 
                       
Loss from continuing operations
    (13,886,306 )     (19,270,375 )     (126,851,871 )
Loss from discontinued operations, net of tax (see Notes 3 and 5)
    (4,477,021 )     (1,411,878 )     (41,143,929 )
 
                 
Net loss
    (18,363,327 )     (20,682,253 )     (167,995,800 )
Deemed dividend associated with beneficial conversion
                (11,423,824 )
Preferred stock dividends
                (1,589,861 )
 
                 
Net loss attributable to common shareholders
  $ (18,363,327 )   $ (20,682,253 )   $ (181,009,485 )
 
                 
 
                       
Per share information:
                       
Loss from continuing operations—basic and diluted
  $ (0.37 )   $ (0.63 )   $ (8.04 )
Loss from discontinued operations—basic and diluted
    (0.12 )     (0.05 )     (2.61 )
Deemed dividend associated with beneficial conversion of preferred stock
                (0.72 )
Preferred stock dividends
                (0.10 )
 
                 
 
                       
Net loss per common share—basic and diluted
  $ (0.49 )   $ (0.68 )   $ (11.47 )
 
                 
Weighted average number of basic and diluted common shares outstanding
    37,639,492       30,376,134       15,780,981  
 
                 
The accompanying notes are an integral part of these consolidated financial statements.

 

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Isolagen, Inc.
(A Development Stage Company)
Consolidated Statements of Shareholders’ Equity (Deficit) and Comprehensive Loss
                                                                                                 
                                                                                    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
        $           $       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
        $           $       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
        $           $       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
        $           $       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
        $           $       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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                                                                                    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
        $           $       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
    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—3 rd 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—3 rd qtr
    (2,967,553 )     (2,967 )     (155,750 )     (156 )     7,188,793       7,189       (82,875 )                             (78,809 )
Conversion of warrants into common stock—3 rd qtr
                            212,834       213       (213 )                              
Compensation expense on warrants issued to non-employees
                                        412,812                               412,812  
Issuance of common stock for cash—4 th qtr
                            136,500       137       279,363                               279,500  
Conversion of warrants into common stock—4 th 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
        $           $       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—1 st qtr
        $           $       78,526     $ 79     $ (79 )         $     $     $     $  
Issuance of common stock for cash in connection with exercise of stock options—1 st qtr
                            15,000       15       94,985                               95,000  
Issuance of common stock for cash in connection with exercise of warrants—1 st qtr
                            4,000       4       7,716                               7,720  
Compensation expense on options and warrants issued to non-employees and directors—1 st qtr
                                        1,410,498                               1,410,498  
Issuance of common stock in connection with exercise of warrants—2 nd qtr
                            51,828       52       (52 )                              
Issuance of common stock for cash—2 nd qtr
                            7,200,000       7,200       56,810,234                               56,817,434  
Compensation expense on options and warrants issued to non-employees and directors—2 nd qtr
                                        143,462                               143,462  
Issuance of common stock in connection with exercise of warrants—3 rd qtr
                            7,431       7       (7 )                              
Issuance of common stock for cash in connection with exercise of stock options—3 rd qtr
                            110,000       110       189,890                               190,000  
Issuance of common stock for cash in connection with exercise of warrants—3 rd qtr
                            28,270       28       59,667                               59,695  
Compensation expense on options and warrants issued to non-employees and directors—3 rd qtr
                                        229,133                               229,133  
Issuance of common stock in connection with exercise of warrants—4 th qtr
                            27,652       28       (28 )                              
Compensation expense on options and warrants issued to non-employees, employees, and directors—4 th qtr
                                        127,497                               127,497  
Purchase of treasury stock—4 th 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
        $           $       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—1 st qtr
        $           $       25,000     $ 25     $ 74,975           $     $     $     $ 75,000  
Compensation expense on options and warrants issued to non-employees—1 st qtr
                                        33,565                               33,565  
Conversion of warrants into common stock—2 nd qtr
                            27,785       28       (28 )                              
Compensation expense on options and warrants issued to non-employees—2 nd qtr
                                        (61,762 )                             (61,762 )
Compensation expense on options and warrants issued to non-employees—3 rd qtr
                                        (137,187 )                             (137,187 )
Conversion of warrants into common stock—3 rd qtr
                            12,605       12       (12 )                              
Compensation expense on options and warrants issued to non-employees—4 th qtr
                                        18,844                               18,844  
Compensation expense on acceleration of options—4 th qtr
                                        14,950                               14,950  
Compensation expense on restricted stock award issued to employee—4 th 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
        $           $       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     Equity  
    Shares     Amount     Shares     Amount     Shares     Amount     Capital     Shares     Amount     Income     Stage     (Deficit)  
Compensation expense on options and warrants issued to non-employees—1 st qtr
        $           $           $     $ 42,810           $     $     $     $ 42,810  
Compensation expense on option awards issued to employee and directors—1 st qtr
                                        46,336                               46,336  
Compensation expense on restricted stock issued to employees—1 st qtr
                            128,750       129       23,368                               23,497  
Compensation expense on options and warrants issued to non-employees—2 nd qtr
                                        96,177                               96,177  
Compensation expense on option awards issued to employee and directors—2 nd qtr
                                        407,012                               407,012  
Compensation expense on restricted stock to employees—2 nd qtr
                                        4,210                               4,210  
Cancellation of unvested restricted stock – 2 nd qtr
                            (97,400 )     (97 )     97                                
Issuance of common stock for cash in connection with exercise of stock options—2 nd qtr
                            10,000       10       16,490                               16,500  
Compensation expense on options and warrants issued to non-employees—3 rd qtr
                                        25,627                               25,627  
Compensation expense on option awards issued to employee and directors—3 rd qtr
                                        389,458                               389,458  
Compensation expense on restricted stock to employees—3 rd qtr
                                        3,605                               3,605  
Issuance of common stock for cash in connection with exercise of stock options—3 rd qtr
                            76,000       76       156,824                               156,900  
Compensation expense on options and warrants issued to non-employees—4 th qtr
                                        34,772                               34,772  
Compensation expense on option awards issued to employee and directors—4 th qtr
                                        390,547                               390,547  
Compensation expense on restricted stock to employees—4 th qtr
                                        88                               88  
Cancellation of unvested restricted stock award—4 th qtr
                            (15,002 )     (15 )     15                                
Comprehensive loss:
                                                                                               
Net loss
                                                                (35,821,406 )     (35,821,406 )
Other comprehensive gain, foreign currency translation adjustment
                                                          657,182             657,182  
 
                                                                                             
Comprehensive loss
                                                                      (35,164,224 )
 
                                                                       
Balance 12/31/06
        $           $       34,362,731     $ 34,363     $ 111,516,561       4,000,000     $ (25,974,000 )   $ (127,462 )   $ (127,073,044 )   $ (41,623,582 )
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)  
Compensation expense on options and warrants issued to non-employees—1 st qtr
        $           $           $     $ 39,742           $     $     $     $ 39,742  
Compensation expense on option awards issued to employee and directors—1 st qtr
                                        448,067                               448,067  
Compensation expense on restricted stock issued to employees—1 st qtr
                                        88                               88  
Issuance of common stock for cash in connection with exercise of stock options—1 st qtr
                            15,000       15       23,085                               23,100  
Expense in connection with modification of employee stock
options —1 st qtr
                                        1,178,483                               1,178,483  
Compensation expense on options and warrants issued to non-employees—2 nd qtr
                                        39,981                               39,981  
Compensation expense on option awards issued to employee and directors—2 nd qtr
                                        462,363                               462,363  
Compensation expense on restricted stock issued to employees—2 nd qtr
                                        88                               88  
Compensation expense on option awards issued to employee and directors—3 rd qtr
                                        478,795                               478,795  
Compensation expense on restricted stock issued to employees—3 rd qtr
                                        88                               88  
Issuance of common stock upon exercise of warrants—3 rd qtr
                            492,613       493       893,811                               894,304  
Issuance of common stock for cash, net of offering costs—3 rd 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—3 rd qtr
                            1,666       2       3,164                               3,166  
Compensation expense on option awards issued to employee and directors—4 th qtr
                                        378,827                               378,827  
Compensation expense on restricted stock issued to employees—4 th qtr
                                        88                               88  
Comprehensive loss:
                                                                                               
Net loss
                                                                (35,573,114 )     (35,573,114 )
Other comprehensive gain, foreign currency translation adjustment
                                                          846,388             846,388  
 
                                                                                             
Comprehensive loss
                                                                      (34,726,726 )
 
                                                                       
Balance 12/31/07
        $           $       41,639,657     $ 41,640     $ 129,208,631       4,000,000     $ (25,974,000 )   $ 718,926     $ (162,646,158 )   $ (58,650,961 )
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 (Loss)     Stage     (Deficit)  
Compensation expense on options and warrants issued to non-employees—1 st qtr
        $           $           $     $ 44,849           $     $     $     $ 44,849  
Compensation expense on option awards issued to employee and directors—1 st qtr
                                        151,305                               151,305  
Expense in connection with modification of employee stock options —1 st qtr
                                        1,262,815                               1,262,815  
Retirement of restricted stock
                            (249 )     (1 )                                   (1 )
Compensation expense on options and warrants issued to non-employees—2 nd qtr
                                        62,697                               62,697  
Compensation expense on option awards issued to employee and directors—2 nd qtr
                                        193,754                               193,754  
Comprehensive loss:
                                                                                               
Net loss
                                                                (18,363,327 )     (18,363,327 )
Reclassification of foreign exchange gain on substantial liquidation of foreign entity...
                                                          (2,133,905 )           (2,133,905 )
Other comprehensive gain, foreign currency translation adjustment
                                                          1,390,383             1,390,383  
 
                                                                                             
Comprehensive loss
                                                                      (19,106,849 )
 
                                                                       
Balance 06/30/08
        $           $       41,639,408     $ 41,639     $ 130,924,051       4,000,000     $ (25,974,000 )   $ (24,596 )   $ (181,009,485 )   $ (76,042,391 )
 
                                                                       
The accompanying notes are an integral part of these consolidated financial statements.

 

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Isolagen, Inc.
(A Development Stage Company)
Consolidated Statements of Cash Flows (Unaudited)
                         
                    Cumulative  
                    Period from  
                    December 28,  
                    1995 (date of  
    Six months ended     inception) to  
    June 30,     June 30,  
    2008     2007     2008  
Cash flows from operating activities:
                       
Net loss
  $ (18,363,327 )   $ (20,682,253 )   $ (167,995,800 )
Adjustments to reconcile net loss to net cash used in operating activities:
                       
Expense related to equity awards
    1,715,420       2,168,812       9,608,369  
Uncompensated contribution of services
                755,556  
Depreciation and amortization
    719,762       759,925       8,434,889  
Provision for doubtful accounts
    (3,746 )     8,511       326,372  
Provision for excessive and/or obsolete inventory
    59,972             59,972  
Amortization of debt issue costs
    374,619       374,620       2,747,210  
Amortization of debt discounts on investments
                (508,983 )
Loss on disposal or impairment of property and equipment
    6,326,855       20,803       10,935,957  
Foreign exchange gain on substantial liquidation of foreign entity
    (2,133,905 )           (2,267,755 )
Minority interest
    (60,495 )     (241,481 )     (384,974 )
Change in operating assets and liabilities, excluding effects of acquisition:
                     
Decrease in restricted cash
    451,382       498,154        
Decrease (increase) in accounts receivable
    22,276       (121,258 )     (134,519 )
Decrease (increase) in other receivables
    (116,675 )     275,217       31,801  
Decrease (increase) in inventory
    14,503       (605,536 )     (581,851 )
Decrease (increase) in prepaid expenses
    187,639       621,838       (470,579 )
Decrease (increase) in other assets
    (12 )     71,547       140,492  
Increase (decrease) in accounts payable
    363,202       (759,396 )     657,463  
Increase (decrease) in accrued expenses and other liabilities
    (1,221,434 )     (54,034 )     3,096,471  
Decrease in deferred revenue
          (347,630 )     (50,096 )
 
                 
Net cash used in operating activities
    (11,663,964 )     (18,012,161 )     (135,600,005 )
 
                 
Cash flows from investing activities:
                       
Acquisition of Agera, net of cash acquired
    (6,679 )           (2,016,520 )
Purchase of property and equipment
    (29,892 )     (97,780 )     (25,511,725 )
Proceeds from the sale of property and equipment, net of selling costs
    6,444,153       925       6,542,201  
Purchase of investments
                (152,998,313 )
Proceeds from sales and maturities of investments
                153,507,000  
 
                 
Net cash provided by (used in) investing activities
    6,407,582       (96,855 )     (20,477,357 )
 
                 
Cash flows from financing activities:
                       
Proceeds from convertible debt
                91,450,000  
Offering costs associated with the issuance of convertible debt
          (19,655 )     (3,746,193 )
Proceeds from notes payable to shareholders, net
                135,667  
Proceeds from the issuance of preferred stock, net
                12,931,800  
Proceeds from the issuance of common stock, net
          23,100       93,753,857  
Cash dividends paid on preferred stock
                (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
          3,445       167,326,996  
 
                 
Effect of exchange rate changes on cash balances
    (82,914 )     (2,893 )     1,790  
 
                       
Net increase (decrease) in cash and cash equivalents
    (5,339,296 )     (18,108,464 )     11,251,424  
Cash and cash equivalents, beginning of period
    16,590,720       31,783,545        
 
                 
Cash and cash equivalents, end of period
  $ 11,251,424     $ 13,675,081     $ 11,251,424  
 
                 
 
                       
Supplemental disclosures of cash flow information:
                       
Cash paid for interest
  $ 1,575,000     $ 1,575,000     $ 11,140,283  
 
                 
Non-cash investing and financing activities:
                       
Deemed dividend associated with beneficial conversion of preferred stock
  $     $     $ 11,423,824  
 
                 
Preferred stock dividend
                1,589,861  
 
                 
Uncompensated contribution of services
                755,556  
 
                 
Common stock issued for intangible assets
                540,000  
 
                 
Equipment acquired through capital lease
                167,154  
 
                 
Increase in receivable in connection with sale of Swiss property
    49,115             49,115  
 
                 
Increase in accrued expenses related to sale of Swiss property
  $ 16,454     $     $ 16,454  
 
                 
The accompanying notes are an integral part of these consolidated financial statements.

 

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Isolagen, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
Note 1—Basis of Presentation, Business and Organization
Isolagen, Inc. (“Isolagen”), a Delaware corporation, is the parent company of Isolagen Technologies, Inc., a Delaware corporation (“Isolagen Technologies”) and Agera Laboratories, Inc., a Delaware corporation (“Agera”). Isolagen 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 common stock of the Company, par value $0.001 per share, (“Common Stock”) is traded on the American Stock Exchange (“AMEX”) under the symbol “ILE.”
The accompanying consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements and footnotes contained within the Company’s Report of Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 07, 2008.
The Company is an aesthetic and therapeutic development stage 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 Isolagen Process. The Company also develops and markets an advanced skin care line with broad application in core target markets through its Agera subsidiary.
The Company acquired 57% of the outstanding common shares of Agera on August 10, 2006. Agera offers a complete line of skincare systems based on a wide array of proprietary formulations, trademarks and nano-peptide technology. These technologically advanced skincare products can be packaged to offer anti-aging, anti-pigmentary and acne treatment systems. Agera markets its product in both the United States and Europe (primarily the United Kingdom). 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 sheet since the date of the acquisition.
In October 2006, the Company reached an agreement with the FDA on the design of a Phase III pivotal study protocol for the treatment of nasolabial folds. The randomized, double-blind protocol was submitted to the FDA under the agency’s Special Protocol Assessment (“SPA”) regulations. Pursuant to this assessment process, the FDA has agreed that the Company’s study design for two identical trials, including patient numbers, clinical endpoints, and statistical analyses, is acceptable to the FDA to form the basis of an efficacy claim for a marketing application. The randomized, double-blind, pivotal Phase III trials will evaluate the efficacy and safety of Isolagen Therapy against placebo in approximately 400 patients with approximately 200 patients enrolled in each trial. The Company completed enrollment of the study and commenced injection of subjects in early 2007. All injections were completed in January 2008 and the data results from this trial are expected during August 2008.
In March 2004, the Company announced positive results of a first Phase III exploratory clinical trial for the Company’s lead facial aesthetics product candidate, and in July 2004 the Company commenced a 200 patient Phase III study of Isolagen Therapy for facial wrinkles consisting of two identical, simultaneous trials. The study was concluded during the second half of 2005. In August 2005 the Company announced that results of this study failed to meet co-primary endpoints. Based on the results of this study, the Company commenced preparations for our second Phase III pivotal study discussed in the preceding paragraph.
During 2006, 2005 and 2004, the Company sold its aesthetic product primarily in the United Kingdom. However, during the fourth quarter of fiscal 2006, the Company decided to close the United Kingdom operation. The Company completed the closure of the United Kingdom operation on March 31, 2007, and as of March 31, 2007, the United Kingdom, Swiss and Australian operations were presented as discontinued operations for all periods presented, as more fully discussed in Note 5.

 

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Through June 30, 2008, the 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 2008. The Company expects to finance its operations primarily through its existing cash and any future financing. However, as described in Note 2, there exists substantial doubt about the Company’s ability to continue as a going concern. The Company’s ability to operate profitably is largely contingent upon its success in obtaining financing, obtaining regulatory approval to sell one or a variety of applications of the Isolagen Therapy, upon its successful development of markets for its products and upon the development of profitable scaleable manufacturing processes. The Company will be required to obtain additional capital prior to or during the fourth quarter of 2008 to continue and expand its operations. No assurance can be given that the Company will be able to obtain such regulatory approvals, successfully develop the markets for its products or develop profitable manufacturing methods. There is no assurance that the Company will be able to obtain any such additional capital as it needs to finance these efforts, through asset sales, equity or debt financing, or any combination thereof, on satisfactory terms or at all. Additionally, no assurance can be given that any such financing, if obtained, will be adequate to meet the Company’s ultimate capital needs and to support the Company’s growth. If adequate capital cannot be obtained on a timely basis and on satisfactory terms, the Company’s operations would be materially negatively impacted.
If the Company achieves growth in its operations in the next few years, such growth could place a strain on its management, administrative, operational and financial infrastructure. The Company may find it necessary to hire additional management, financial and sales and marketing personnel to manage the Company’s expanding operations. In addition, the Company’s ability to manage its current operations and future growth requires the continued improvement of operational, financial and management controls, reporting systems and procedures. If the Company is unable to manage this growth effectively and successfully, the Company’s business, operating results and financial condition may be materially adversely affected.
Acquisition and merger and basis of presentation
On August 10, 2001, Isolagen Technologies consummated a merger with American Financial Holdings, Inc. (“AFH”) and Gemini IX, Inc., a Delaware corporation, (“Gemini”). Pursuant to an Agreement and Plan of Merger, dated August 1, 2001, by and among AFH, ISO Acquisition Corp, a Delaware corporation and wholly-owned subsidiary of AFH (“Merger Sub”), Isolagen Technologies, Gemini, and William J. Boss, Jr., Olga Marko and Dennis McGill, stockholders of Isolagen Technologies (the “Merger Agreement”), AFH (i) issued 5,453,977 shares of its common stock, par value $0.001, to acquire, in a privately negotiated transaction, 100% of the issued and outstanding common stock (195,707 shares, par value $0.01, including the shares issued immediately prior to the Merger for the conversion of certain liabilities, as discussed below) of Isolagen Technologies, and (ii) issued 3,942,400 shares of its common stock to acquire 100% of the issued and outstanding common stock of Gemini. Pursuant to the terms of the Merger Agreement, Merger Sub, together with Gemini, merged with and into Isolagen Technologies (the “Merger”), and AFH was the surviving corporation. AFH subsequently changed its name to Isolagen, Inc. on November 13, 2001. Prior to the Merger, Isolagen Technologies had no active business and was seeking funding to begin FDA trials of the Isolagen Therapy. AFH was a non-operating, public shell company with limited assets. Gemini was a non-operating private company with limited assets and was unaffiliated with AFH.
The consolidated financial statements presented include Isolagen, Inc., its wholly-owned subsidiaries and its majority-owned subsidiary. All significant intercompany transactions and balances have been eliminated. Isolagen Technologies was, for accounting purposes, the surviving entity of the Merger, and accordingly for the periods prior to the Merger, the financial statements reflect the financial position, results of operations and cash flows of Isolagen Technologies. The assets, liabilities, operations and cash flows of AFH and Gemini are included in the consolidated financial statements from August 10, 2001 onward.
The consolidated financial statements included herein as of June 30, 2008, and for each of the three and six months ended June 30, 2008 and 2007, have been prepared by the Company without an audit, pursuant to accounting principles generally accepted in the United States, and the rules and regulations of the SEC. The consolidated financial statements do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. The information presented reflects all adjustments consisting solely of normal recurring adjustments which are, in the opinion of management, considered necessary to present fairly the financial position, results of operations, and cash flows for the periods discussed above. Operating results for the three and six months ended June 30, 2008, are not necessarily indicative of the results which will be realized for the year ending December 31, 2008.

 

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Unless the context requires otherwise, the “Company” refers to Isolagen, Inc. and all of its consolidated subsidiaries, “Isolagen” refers to Isolagen, Isolagen Technologies, Isolagen Europe, Isolagen Australia and Isolagen Switzerland, and “Agera” refers to Agera Laboratories, Inc.
Note 2—Going Concern
At June 30, 2008, the Company had cash and cash equivalents of $11.3 million and working capital of $8.6 million (including cash and cash equivalents). The Company believes that its existing capital resources are adequate to finance its operations through approximately December 1, 2008, under the Company’s normal operating conditions. As such, the Company estimates that it will require additional cash resources prior to or during the fourth quarter of 2008 based upon its current operating plan and condition.
Through June 30, 2008, the 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 2008. The Company expects to finance its operations primarily through its existing cash and any future financing, including the sale of assets. However, there exists substantial doubt about the Company’s ability to continue as a going concern.
As discussed in Note 1, the Company expects to receive in August 2008 the results of pivotal Phase III trials to evaluate the efficacy and safety of Isolagen Therapy for the treatment of nasolabial folds. If those results support the efficacy and safety of the Isolagen Treatment for that purpose, further efforts will be required to obtain final regulatory approval, develop a scalable manufacturing process, and develop the market for the use of the Isolagen Therapy for the treatment of nasolabial folds. The Company would be required to obtain additional capital in the future to continue its operations. There is no assurance that the Company will be able to obtain any such additional capital as it needs to finance these efforts, through asset sales, equity or debt financing, or any combination thereof, on satisfactory terms or at all. Additionally, no assurance can be given that any such financing, if obtained, will be adequate to meet the Company’s ultimate capital needs and to support the Company’s growth. If adequate capital cannot be obtained on a timely basis and on satisfactory terms, the Company’s operations would be materially negatively impacted. Further, if the Company does not obtain additional funding prior to or during the fourth quarter of 2008, it may enter into bankruptcy soon thereafter, and possibly cease operations.
Conversely, if the results of these pivotal Phase III trials do not support the efficacy and safety of Isolagen Therapy for the treatment of nasolabial folds, it may indicate that the Isolagen Therapy as currently manufactured and administered will not obtain regulatory approval and could not be successfully marketed. In that case, the Company would be required to research and develop significant changes to the Isolagen Therapy. Such an effort would require substantial additional capital, and there is substantial doubt that the Company could obtain such capital. In such event, the Company might be forced to cease operations and enter into bankruptcy.
The Company filed a shelf registration statement on Form S-3 during June 2007, which was subsequently declared effective by the SEC. The shelf registration allows the Company the flexibility to offer and sell, from time to time, up to an original amount of $50 million of common stock, preferred stock, debt securities, warrants or any combination of the foregoing in one or more future public offerings. In August 2007, the Company sold under this shelf registration statement 6,746,647 shares of common stock to institutional investors, raising proceeds of $13.8 million, net of offering costs. The Company may offer and sell up to an additional $36.2 million of securities pursuant to this shelf registration.
The Company’s ability to complete additional offerings, including any additional offerings under its shelf registration statement, 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 Company and the offering terms. In addition, the Company’s ability to complete an offering may be dependent on the status of its clinical trials, and in particular, the status of its Phase III clinical trial for the treatment of nasolabial folds as discussed above, 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.

 

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As a result of the conditions discussed above, and in accordance with generally accepted accounting principles in the United States, there exists substantial doubt about the Company’s ability to continue as a going concern, and the Company’s ability to continue as a going concern is contingent, among other things, upon its ability to secure additional adequate financing or capital prior to or during the fourth quarter of 2008. If the Company is unable to obtain additional sufficient funds during this time, the Company will be required to terminate or delay its efforts to obtain regulatory approval of one, more than one, or all of its product candidates, curtail or delay the implementation of manufacturing process improvements and/or delay the expansion of its sales and marketing capabilities. Any of these actions would have an adverse effect on the Company’s operations, the realization of its assets and the timely satisfaction of its liabilities. Further, if the Company does not obtain additional funding prior to or during the fourth quarter of 2008, it may enter into bankruptcy soon thereafter, and possibly cease operations. The Company’s financial statements are presented on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability of the recorded assets or the classification of liabilities that may be necessary should it be determined that the Company is unable to continue as a going concern.
Note 3—Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Examples include provisions for bad debts and inventory obsolescence, useful lives of property and equipment and intangible assets, impairment of property and equipment and intangible assets, deferred taxes, the provision for and disclosure of litigation and loss contingencies (see Note 7) and estimates and assumptions related to equity-based compensation expense (see Note 8). Actual results may differ materially from those estimates.
Foreign Currency Translation
The financial position and results of operations of the Company’s foreign subsidiaries are determined using the local currency as the functional currency. Assets and liabilities of these subsidiaries are translated at the exchange rate in effect at each period end. Income statement accounts are translated at the average rate of exchange prevailing during the period. Adjustments arising from the use of differing exchange rates from period to period are included in accumulated other comprehensive (loss) income in shareholders’ deficit. Gains and losses resulting from foreign currency transactions are included in earnings and, other than discussed below, have not been material in any one period. Balances of related after-tax components comprising accumulated other comprehensive income (loss) included in shareholders’ deficit at June 30, 2008 and December 31, 2007 related solely to foreign currency translation adjustments.
Upon sale or upon complete or substantially complete liquidation of an investment in a foreign entity, the amount attributable to that entity and accumulated in the translation adjustment component of equity is removed from the separate component of equity and is reported as gain or loss for the period during which the sale or liquidation occurs. During March 2008, the Company substantially liquidated the assets of the Company’s Swiss entity (in connection with the sale of the Company’s Swiss campus; see Assets of Discontinued Operations Held for Sale below). As such, the amount of the accumulated foreign currency translation adjustment account in stockholders’ deficit which related to the Company’s Swiss franc assets and liabilities was removed from equity by recording income of $2.1 million, which is included in loss from discontinued operations in the accompanying consolidated statement of operations for the three and six months ended June 30, 2008.
Statement of Cash Flows
For purposes of the statements of cash flows, the Company considers all highly liquid investments (i.e., investments which, when purchased, have maturities of three months or less) to be cash equivalents. The Company had restricted cash of $0.0 million and $0.5 million at June 30, 2008 and December 31, 2007, respectively, reserved for the payment of the original non-cancelable portion of the Exton, Pennsylvania facility lease.

 

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Concentration of Credit Risk
The Company maintains its cash primarily with major U.S. domestic banks. The amounts held in these banks generally exceed the insured limit of $100,000. The terms of these deposits are on demand to minimize risk. The Company has historically not incurred bank default losses related to these deposits. Cash equivalents are maintained with one domestic financial institution. The Company invests its cash equivalents primarily in government securities.
Allowance for Doubtful Accounts
The Company maintains an allowance for doubtful accounts related to its accounts receivable that have been deemed to have a high risk of collectibility. Management reviews its accounts receivable on a monthly basis to determine if any receivables will potentially be uncollectible. Management analyzes historical collection trends and changes in its customer payment patterns, customer concentration, and creditworthiness when evaluating the adequacy of its allowance for doubtful accounts. In its overall allowance for doubtful accounts, the Company includes any receivable balances that are determined to be uncollectible. Based on the information available, management believes the allowance for doubtful accounts is adequate; however, actual write-offs might exceed the recorded allowance.
Inventory
Agera purchases the large majority of its inventory from one contract manufacturer. Agera accounts for its inventory on the first-in-first-out method. During the three months ended March 31, 2008 and six months ended June 30, 2008, the Company recorded a charge for excessive and/or obsolete inventory of $60,000, and as such, the inventory balance within the accompanying consolidated balance sheet at June 30, 2008 is presented net of this $60,000 inventory reserve. At June 30, 2008, Agera’s inventory, net of reserves, consisted of $0.2 million of raw materials and $0.4 million of finished goods. At December 31, 2007, Agera’s inventory consisted of $0.1 million of raw materials and $0.6 million of finished goods.
Assets of Discontinued Operations Held for Sale
In April 2005, the Company acquired land and a two-building, 100,000 square foot campus (the “Swiss campus”) in Bevaix, Canton of Neuchâtel, Switzerland. In March 2008, the Company sold its Swiss campus to a third party for approximately $6.4 million, net of transaction costs. The net book value of the Swiss campus on the date of sale was approximately $12.7 million (or $10.6 million, net of the related cumulative foreign currency translation gain of approximately $2.1 million, as discussed in Foreign Currency Translation above). In connection with this sale of the Swiss campus, the Company recorded a net loss of $4.2 million which is reflected in loss from discontinued operations in the accompanying consolidated statement of operations for the six months ended June 30, 2008 (refer to Note 5 for further detail related to the net loss on the sale of the Swiss campus). As of June 30, 2008, $6.4 million of the net sale proceeds had been paid to the Company, and less than $0.1 million was recorded as a receivable within currents assets of discontinued operations in the accompanying consolidated balance sheet.
Property and equipment
Property and equipment is carried at cost less accumulated depreciation and amortization. Generally, depreciation and amortization for financial reporting purposes is provided by the straight-line method over the estimated useful life of three years, except for leasehold improvements which are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter. The cost of repairs and maintenance is charged as an expense as incurred.
Intangible assets
Intangible assets primarily include proprietary formulations and trademarks, which were acquired in connection with the acquisition of Agera (see Note 4), as well as certain in-process patents. Proprietary formulations and trademarks are amortized on a straight-line basis over their estimated useful lives, generally for periods ranging from 13 to 18 years. The Company periodically evaluates the reasonableness of the useful lives of these assets. Intangibles are tested for recoverability whenever events or changes in circumstances indicate the carrying amount may not be recoverable. An impairment loss, if any, would be measured as the excess of the carrying value over the fair value determined by discounted cash flows.

 

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Intangible assets are comprised as follows:
                 
    June 30,     December 31,  
    2008     2007  
Proprietary formulations
  $ 3,101,100     $ 3,101,100  
Trademarks
    1,511,400       1,511,400  
Other intangibles
    705,800       705,800  
 
           
 
    5,318,300       5,318,300  
Less: Accumulated amortization
    (886,119 )     (718,762 )
 
           
Intangible assets, net
  $ 4,432,181     $ 4,599,538  
 
           
Debt Issue Costs
The costs incurred in issuing the Company’s 3.5% Convertible Subordinated Notes, including placement agent fees, legal and accounting costs and other direct costs are included in other assets and are being amortized to expense using the effective interest method over five years, through November 2009 (the first call date of the $90 million of convertible subordinated debt). Debt issuance costs, net of amortization, were approximately $1.0 million at June 30, 2008 and approximately $1.4 million at December 31, 2007 and were included in other assets, net, in the accompanying consolidated balance sheets.
Treasury Stock
The Company utilizes the cost method for accounting for its treasury stock acquisitions and dispositions.
Revenue recognition
The Company recognizes revenue over the period the service is performed in accordance with SEC Staff Accounting Bulletin No. 104, “Revenue Recognition in Financial Statements” (“SAB 104”). In general, SAB 104 requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services rendered, (3) the fee is fixed and determinable and (4) collectibility is reasonably assured.
Continuing operations : Revenue from the sale of Agera’s products is recognized upon transfer of title, which is upon shipment of the product to the customer. The Company believes that the requirements of SAB 104 are met when the ordered product is shipped, as the risk of loss transfers to its customer at that time, the fee is fixed and determinable and collection is reasonably assured. Any advanced payments are deferred until shipment.
Discontinued operations: The Isolagen Therapy was administered, in the United Kingdom, to each patient using a recommended regimen of injections. Due to the shelf life, each injection was cultured on an as needed basis and shipped prior to the individual injection being administered by the physician. The Company believes each injection had stand alone value to the patient. The Company invoiced the attending physician when the physician sent his or her patient’s tissue sample to the Company which created a contractual arrangement between the Company and the medical professional. The amount invoiced varied directly with the dose and number of injections requested. Generally, orders were paid in advance by the physician prior to the first injection. There was no performance provision under any arrangement with any physician, and there was no right to refund or returns for unused injections.
As a result, the Company believes that the requirements of SAB 104 were met as each injection was shipped, as the risk of loss transferred to its physician customer at that time, the fee was fixed and determinable and collection was reasonably assured. Advance payments were deferred until shipment of the injection(s). The amount of the revenue deferred represented the fair value of the remaining undelivered injections measured in accordance with Emerging Issues Task Force Issue (“EITF”) 00-21, “Accounting for Revenue Arrangements with Multiple Deliverables,” which addresses the issue of accounting for arrangements that involve the delivery of multiple products or services. Should the physician have discontinued the regimen prematurely all remaining deferred revenue was recognized.

 

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Shipping and handling costs
Agera charges its customers for shipping and handling costs. Such charges to customers are presented net of the costs of shipping and handling, as selling, general and administrative expense, and are not significant to the consolidated statements of operations.
Advertising cost
Agera advertising costs are expensed as incurred and include the costs of public relations and certain marketing related activities. These costs are included in selling, general and administrative expenses in the accompanying consolidated statements of operations.
Research and development expenses
Research and development costs are expensed as incurred and include salaries and benefits, costs paid to third-party contractors to perform research, conduct clinical trials, develop and manufacture drug materials and delivery devices, and a portion of facilities cost. Research and development costs also include costs to develop manufacturing, cell collection and logistical process improvements.
Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. Invoicing from third-party contractors for services performed can lag several months. The Company accrues the costs of services rendered in connection with third-party contractor activities based on its estimate of management fees, site management and monitoring costs and data management costs. Actual clinical trial costs may differ from estimated clinical trial costs and are adjusted for in the period in which they become known.
Stock-based compensation
Effective January 1, 2006, the Company adopted the provisions of Statement of Financial Accounting Standards (“SFAS”) No. 123 (revised 2004), “Share-Based Payment” (“SFAS No. 123(R)”). SFAS No. 123(R) replaces SFAS No. 123, “Accounting for Stock-Based Compensation”, supersedes APB Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB No. 25”), and amends SFAS No. 95, “Statement of Cash Flows.” SFAS No. 123(R) requires entities to recognize compensation expense for all share-based payments to employees and directors, including grants of employee stock options, based on the grant-date fair value of those share-based payments, adjusted for expected forfeitures. The Company adopted SFAS No. 123(R) using the modified prospective application method. Under the modified prospective application method, the fair value measurement requirements of SFAS No. 123(R) is applied to new awards and to awards modified, repurchased, or cancelled after January 1, 2006. Additionally, compensation cost for the portion of awards for which the requisite service has not been rendered that were outstanding as of January 1, 2006 is recognized as the requisite service is rendered on or after January 1, 2006. The compensation cost for that portion of awards is based on the grant-date fair value of those awards as calculated for pro forma disclosures under SFAS No. 123. Changes to the grant-date fair value of equity awards granted before January 1, 2006 are precluded.
Prior to the adoption of SFAS No. 123(R), the Company followed the intrinsic value method in accordance with APB No. 25 to account for its employee stock options. Historically, substantially all stock options have been granted with an exercise price equal to the fair market value of the common stock on the date of grant. Accordingly, no compensation expense was recognized from substantially all option grants to employees and directors. Compensation expense was recognized in connection with the issuance of stock options to non-employee consultants in accordance with EITF 96-18, “Accounting for Equity Instruments That are Issued to Other than Employees for Acquiring, or in Conjunction with Selling Goods and Services.” SFAS No. 123(R) did not change the accounting for stock-based compensation related to non-employees in connection with equity based incentive arrangements.

 

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Income taxe s
An asset and liability approach is used for financial accounting and reporting for income taxes. Deferred income taxes arise from temporary differences between income tax and financial reporting and principally relate to recognition of revenue and expenses in different periods for financial and tax accounting purposes and are measured using currently enacted tax rates and laws. In addition, a deferred tax asset can be generated by net operating loss carryforwards (“NOLs”). If it is more likely than not that some portion or all of a deferred tax asset will not be realized, a valuation allowance is recognized.
In the event the Company is charged interest or penalties related to income tax matters, the Company would record such interest as interest expense and would record such penalties as other expense in the consolidated statement of operations. No such charges have been incurred by the Company. As of June 30, 2008 and December 31, 2007, the Company had no accrued interest related to uncertain tax positions.
The Company adopted the provisions of Financial Standards Accounting Board Interpretation No. 48 Accounting for Uncertainty in Income Taxes (“FIN 48”), an interpretation of FASB Statement No. 109 (“SFAS 109”) on January 1, 2007. No material adjustment in the liability for unrecognized income tax benefits was recognized as a result of the adoption of FIN 48. At June 30, 2008 and December 31, 2007, the Company had $60.4 million and $54.8 million, respectively, of unrecognized tax benefits; the large majority of which relates to loss carryforwards for which the Company has provided a full valuation allowance. The tax years 2004 through 2007 remain open to examination by the major taxing jurisdictions to which we are subject.
Loss per share data
Basic loss per share is calculated based on the weighted average common shares outstanding during the period, after giving effect to the manner in which the merger was accounted for as described in Note 1. Diluted earnings per share also gives effect to the dilutive effect of stock options, warrants (calculated based on the treasury stock method) and convertible notes and convertible preferred stock. The Company does not present diluted earnings per share for years in which it incurred net losses as the effect is antidilutive.
At June 30, 2008, options and warrants to purchase 8,798,412 shares of common stock at exercise prices ranging from $0.41 to $9.81 per share were outstanding, but were not included in the computation of diluted earnings per share as their effect would be antidilutive. Also, 9,828,009 shares issuable upon the conversion of the Company’s convertible notes, at a conversion price of approximately $9.16, were not included as their effect would be antidilutive.
At June 30, 2007, options and warrants to purchase 9,178,089 shares of common stock at exercise prices ranging from $1.50 to $9.81 per share were outstanding, but were not included in the computation of diluted earnings per share as their effect would be antidilutive. Also, 9,828,009 shares issuable upon the conversion of the Company’s convertible notes, at a conversion price of approximately $9.16, were not included as their effect would be antidilutive.
Fair Value of Financial Instruments
The Company’s financial instruments consist of accounts receivable, marketable debt securities, accounts payable and convertible subordinated debentures. The fair values of the Company’s accounts receivable and accounts payable approximate, in the Company’s opinion, their respective carrying amounts. The Company’s convertible subordinated debentures were quoted at approximately 10% and 74% of par value at June 30, 2008 and December 31, 2007, respectively. Accordingly, the fair value of the Company’s convertible subordinated debentures was approximately $8.7 million and $66.6 million at June 30, 2008 and December 31, 2007, respectively. The Company’s convertible subordinated debentures are publicly traded. The fair value of the convertible subordinated debentures are estimated based on primary factors such as (1) the most recent trade prices of the convertible subordinated debentures on or near the respective reporting period end and/or (2) the bid and ask prices of the convertible subordinated debentures at the end of the reporting period. Historically, these factors have fluctuated significantly, and these factors are expected to fluctuate in future periods. Accordingly, the fair value of the convertible subordinated debentures has historically fluctuated significantly, and is expected to fluctuate in future periods.

 

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Recently Issued Accounting Standards Not Yet Effective
In December 2007, the Financial Accounting Standards Board released SFAS No. 141-R, “Business Combinations.” This Statement applies prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008, which is any business combination in the year ending December 31, 2009 for the Company. SFAS No. 141-R makes changes to the manner in which purchase business combinations, and in particular partial and step acquisitions, and minority interests, are measured and recorded. The objective of this Statement is to improve the relevance, representational faithfulness, and comparability of the information that a reporting entity provides in its financial reports about a business combination and its effects. The Company is currently assessing the impact the adoption of this pronouncement will have on the financial statements.
In December 2007, the Financial Accounting Standards Board released SFAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements — an amendment of ARB No. 51.” This Statement is effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2008, which for the Company is the year ending December 31, 2009 and the interim periods within that fiscal year. SFAS No. 160 changes the manner in which minority interests are classified in consolidated financial statements, and the accounting for changes in minority interests. The objective of this pronouncement is to improve the relevance, comparability and transparency of the financial information that a reporting entity provides in its consolidated financial statements. The Company is currently assessing the impact the adoption of this pronouncement will have on the financial statements.
Note 4—Acquisition of Agera Laboratories, Inc.
On August 10, 2006, the Company acquired 57% of the outstanding common shares of Agera Laboratories, Inc. (“Agera”). Agera is a skincare company that has proprietary rights to a scientifically-based advanced line of skincare products. Agera markets its product in both the United States and Europe. The Company believes that the acquisition of Agera will complement the Company’s Isolagen Therapy and will broaden the Company’s position in the skincare market as Agera has a comprehensive range of technologically advanced skincare products that can be packaged to offer anti-aging, anti-pigmentary and acne treatment systems.
The acquisition has been accounted for as a purchase. Accordingly, the bases in Agera’s assets and liabilities have been adjusted to reflect the allocation of the purchase price to the 57% interest the Company acquired (with the remaining 43% interest, and the minority interest in Agera’ net assets, recorded at Agera’s historical book values), and the results of Agera’s operations and cash flows have been included in the consolidated financial statements from the date of the acquisition.
The Company paid $2.7 million in cash to acquire the 57% interest in Agera and in connection with the acquisition contributed $0.3 million to the working capital of Agera. Included in the purchase price was an option to acquire an additional 8% of Agera’s outstanding common shares for an exercise price of $0.5 million in cash. This option expired unexercised in February 2007. In addition, the acquisition agreement includes future contingent payments up to a maximum of $8.0 million. Such additional purchase price is based upon certain percentages of Agera’s cost of sales incurred after June 30, 2007. Accordingly, based upon the financial performance of Agera, up to an additional $8.0 million of purchase price may be due the selling shareholder in future periods. As of June 30, 2008, less than $0.1 million has been paid with respect to the additional purchase price and less than $0.1 million was due.

 

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The following table summarizes the allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed at the date of acquisition. These assets and liabilities were included in the consolidated balance sheet as of the acquisition date.
         
Current assets
  $ 1,531,926  
Intangible assets
    4,522,120  
 
     
Total assets acquired
    6,054,046  
 
     
 
       
Current liabilities
    30,284  
Deferred tax liability, net
    190,754  
Other long—term liabilities
    695,503  
Minority interest
    2,182,505  
 
     
Total liabilities assumed and minority interest
    3,099,046  
 
     
Net assets acquired
  $ 2,955,000  
 
     
Of the $4.5 million, net, of acquired intangible assets, $4.4 million, net, was assigned to product formulations and trademarks, which have a weighted average useful life of approximately 16 years. No amount of the purchase price was assigned to goodwill.
Note 5— Discontinued Operations and Exit Costs
As part of the Company’s continuing efforts to evaluate the best uses of its resources, in the fourth quarter of 2006 the Company’s Board of Directors approved the closing of the Company’s United Kingdom operation. On March 31, 2007, the Company completed the closure of its United Kingdom manufacturing facility. The United Kingdom operation was located in London, England with two locations; a manufacturing site and an administrative site. Both sites were under operating leases. The manufacturing site lease expires February 2010 and, as of June 30, 2008, the remaining lease obligation approximated $0.4 million. The administrative site lease expired in April 2007. The Company believes that substantially all costs related to the closure of the United Kingdom operation have been incurred by June 30, 2008, excluding the remaining lease obligation discussed above and any potential claims or contingencies unknown or which cannot be estimated at this time (see Note 7).
As a result of the closure of the Company’s United Kingdom operation, the operations that the Company previously conducted in Switzerland and Australia, which when closed had been absorbed into the United Kingdom operation, were also classified as discontinued operations as of March 31, 2007. The Company recorded a fixed asset impairment charge related to its United Kingdom operation of $1.4 million during 2006, which is included in loss from discontinued operations in the consolidated statement of operations for the cumulative period from December 28, 1995 (date of inception) to June 30, 2008. During March 2008, the Company sold its buildings located in Switzerland (see Note 3). All assets, liabilities and results of operations of the United Kingdom, Switzerland and Australian operations are reflected as discontinued operations in the accompanying consolidated financial statements. All prior period information has been restated to reflect the presentation of discontinued operations.

 

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The following sets forth the components of assets and liabilities of discontinued operations as of June 30, 2008 and December 31, 2007:
                 
    June 30,     December 31,  
(in millions)   2008     2007  
Receivable due on sale of Swiss campus and other, net
  $ 0.1     $  
 
           
Total current assets
    0.1        
Assets held for sale
          11.2  
Long term assets
    0.1       0.1  
 
           
Total assets
  $ 0.2     $ 11.3  
 
           
 
               
Accounts payable
  $ 0.1     $  
Accrued expenses and other current liabilities
    0.3       0.2  
 
           
Total current liabilities
    0.4       0.2  
Long term liabilities
    0.1       0.1  
 
           
Total liabilities
  $ 0.5     $ 0.3  
 
           
The following sets forth the results of operations of discontinued operations for the three months ended June 30, 2008, and June 30, 2007:
                 
    June 30,     June 30,  
(in millions)   2008     2007  
Net revenue
  $     $  
 
               
Gross loss
           
Loss on sale of Swiss campus, gross of foreign currency gain
           
Operating loss
    (0.2 )     (0.3 )
Foreign exchange gain on substantial liquidation of foreign entity
           
Other income
           
 
           
Loss from discontinued operations
  $ (0.2 )   $ (0.3 )
 
           
The following sets forth the results of operations of discontinued operations for the six months ended June 30, 2008, and June 30, 2007:
                 
    June 30,     June 30,  
(in millions)   2008     2007  
Net revenue
  $     $ 0.2  
 
               
Gross loss
          (0.3 )
Loss on sale of Swiss campus, gross of foreign currency gain
    (6.3 )      
Operating loss
    (6.7 )     (1.5 )
Foreign exchange gain on substantial liquidation of foreign entity
    2.1        
Other income
    0.1       0.1  
 
           
Loss from discontinued operations
  $ (4.5 )   $ (1.4 )
 
           
The foreign exchange gain recorded during the six months ended June 30, 2008 results from removing from the accumulated foreign currency translation adjustment account in stockholders’ deficit a credit balance which related to the translation into U.S. dollars of the Company’s Swiss franc assets and liabilities. The credit balance which had accumulated, and the resulting gain recorded upon the substantial liquidation of the Company’s Swiss franc assets, reflected the increase in the value of the Swiss franc relative to the U.S. dollar over the period that the Company operated in Switzerland.

 

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The following sets forth information about the major components of the United Kingdom operation exit costs incurred through March 31, 2007. No such costs for employee severance or fixed asset impairments were incurred subsequent to March 31, 2007:
                 
    Costs Incurred for the        
    Three Months Ended     Cumulative Costs  
    March 31, 2007     Incurred to Date  
Employee severance
  $ 183,222     $ 467,318  
Fixed asset impairment
          1,445,647  
 
           
 
               
Total
  $ 183,222     $ 1,912,965  
 
           
The following sets forth information about the changes in the UK accrued exit costs for the three months ended March 31, 2007:
                                 
    Accrued Liability     Costs Charged     Costs Paid     Accrued Liability  
    January 1, 2007     to Expense     or Settled     March 31, 2007  
Employee severance
  $ 284,096     $ 183,222     $ 467,318     $  
 
                       
Total
  $ 284,096     $ 183,222     $ 467,318     $  
 
                       
Note 6—Accrued Expenses
Accrued expenses are comprised of the following:
                 
    June 30,     December 31,  
    2008     2007  
Accrued professional fees
  $ 1,786,306     $ 2,243,319  
Accrued compensation
    370,978       840,641  
Accrued severance
    59,999       379,402  
Accrued interest
    525,000       525,000  
Accrued other
    370,790       359,894  
 
           
Accrued expenses
  $ 3,113,073     $ 4,348,256  
 
           
Note 7—Commitments and Contingencies
Federal Securities Litigation
The Company and certain of its current and former officers and directors are defendants in class action cases pending in the United States District Court for the Eastern District of Pennsylvania.
In August 2005 and September 2005, various lawsuits were filed alleging securities fraud and asserting claims on behalf of a putative class of purchasers of publicly traded Isolagen securities between March 3, 2004 and August 1, 2005. These lawsuits were Elliot Liff v. Isolagen, Inc. et al. , C.A. No. H-05-2887, filed in the United States District Court for the Southern District of Texas; Michael Cummiskey v. Isolagen, Inc. et al. , C.A. No. 05-cv-03105, filed in the United States District Court for the Southern District of Texas; Ronald A. Gargiulo v. Isolagen, Inc. et al. , C.A. No. 05-cv-4983, filed in the United States District Court for the Eastern District of Pennsylvania, and Gregory J. Newman v. Frank M. DeLape, et al. , C.A. No. 05-cv-5090, filed in the United States District Court for the Eastern District of Pennsylvania.
The Liff and Cummiskey actions were consolidated on October 7, 2005. The Gargiolo and Newman actions were consolidated on November 29, 2005. On November 18, 2005, the Company filed a motion with the Judicial Panel on Multidistrict Litigation (the “MDL Motion”) to transfer the Federal Securities Actions and the Keene derivative case (described below) to the United States District Court for the Eastern District of Pennsylvania. The Liff and Cummiskey actions were stayed on November 23, 2005 pending resolution of the MDL Motion. The Gargiulo and Newman actions were stayed on December 7, 2005 pending resolution of the MDL Motion. On February 23, 2006, the MDL Motion was granted and the actions pending in the Southern District of Texas were transferred to the Eastern District of Pennsylvania, where they have been captioned In re Isolagen, Inc. Securities & Derivative Litigation , MDL No. 1741 (the “Federal Securities Litigation”).
On April 4, 2006, the United States District Court for the Eastern District of Pennsylvania appointed Silverback Asset Management, LLC, Silverback Master, Ltd., Silverback Life Sciences Master Fund, Ltd., Context Capital Management, LLC and Michael F. McNulty as Lead Plaintiffs, and the law firms of Bernstein Litowitz Berger & Grossman LLP and Kirby McInerney & Squire LLP as Lead Counsel in the Federal Securities Litigation.

 

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On July 14, 2006, Lead Plaintiffs filed a Consolidated Class Action Complaint in the Federal Securities Litigation on behalf of a putative class of persons or entities who purchased or otherwise acquired Isolagen common stock or convertible debt securities between March 3, 2004 and August 9, 2005. The complaint purports to assert claims for securities fraud in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 against Isolagen and certain of its former officers and directors. The complaint also purports to assert claims for violations of Section 11 and 12 of the Securities Act of 1933 against the Company and certain of its current and former directors and officers in connection with the registration and sale of certain shares of Isolagen common stock and certain convertible debt securities. The complaint also purports to assert claims against CIBC World Markets Corp., Legg Mason Wood Walker, Inc., Canaccord Adams, Inc. and UBS Securities LLC as underwriters in connection with an April 2004 public offering of Isolagen common stock and a 2005 sale of convertible notes. On November 1, 2006, the defendants moved to dismiss the complaint. On September 26, 2007, the court denied the Company’s motions to dismiss the complaint. On November 6, 2007, the court entered a scheduling order that provides for discovery to be complete by June 8, 2009.
On April 1, 2008, the court entered an order staying the schedule set forth in its November 6, 2007 order for a period of 90 days and directing the parties (together with the parties in the Beattie action, described under “Derivative Actions,” below) to participate in mediation before a private mediator. The mediation occurred on June 2, 2008 and June 5, 2008, and the parties continue attempts toward reaching a resolution of the actions. However, there can be no assurance that a resolution of the actions will be accomplished in the future.
If the parties’ efforts do not lead to a resolution of the lawsuits, the Company intends to continue to defend them vigorously. The Company cannot currently estimate the amount of loss, if any, that may result from the resolution of these actions, and no provision has been recorded in the consolidated financial statements. The Company will expense its legal costs as they are incurred and will record any insurance recoveries on such legal costs in the period the recoveries are received.
Derivative Actions
The Company is the nominal defendant in derivative actions (the “Derivative Actions”) pending in State District Court in Harris County, Texas, the United States District Court for the Eastern District of Pennsylvania, and the Court of Common Pleas of Chester County, Pennsylvania.
On September 28, 2005, Carmine Vitale filed an action styled, Case No. 2005-61840, Carmine Vitale v. Frank DeLape, et al. in the 55 th Judicial District Court of Harris County, Texas and in February 2006 Mr. Vitale filed an amended petition. In this action, the plaintiff purports to bring a shareholder derivative action on behalf of the Company against certain of the Company’s current and former officers and directors. The Plaintiff alleges that the individual defendants breached their fiduciary duties to the Company and engaged in other wrongful conduct. Jeffrey Tomz, who formerly served as Isolagen’s Chief Financial Officer, was accused of engaging in insider trading of Isolagen stock through a proxy. The plaintiff did not make a demand on the Board of Isolagen prior to bringing the action and plaintiff alleges that a demand was excused under the law as futile.
On December 2, 2005, the Company filed its answer and special exceptions pursuant to Rule 91 of the Texas Rules of Civil Procedure based on pleading defects inherent in the Vitale petition. The plaintiff filed an amended petition on February 15, 2006, to which the defendants renewed their special exceptions. On September 6, 2006, the Court granted the special exceptions and permitted the plaintiff thirty days to attempt to replead. Thereafter the plaintiff moved the Court for an order compelling discovery, which the Court denied on October 2, 2006. On October 18, 2006, the Court entered an order explaining its grounds for granting the special exceptions. On November 3, 2006, the plaintiff filed a second amended petition. On February 8, 2007, the Company filed its answer and special exceptions to the second amended petition. On August 9, 2007, the Court granted the special exceptions and dismissed the second amended petition with prejudice. On September 4, 2007, the plaintiff moved for reconsideration of the dismissal with prejudice of the second amended petition, for a new trial, and for leave to further amend the petition, and the defendants opposed that motion on September 20, 2007. On October 23, 2007, that motion was deemed denied by operation of law because the court had not acted on it by that date.

 

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On October 8, 2005, Richard Keene filed an action styled, C.A. No. H-05-3441, Richard Keene v. Frank M. DeLape et al., in the United States District Court for the Southern District of Texas. This action makes substantially similar allegations as the original complaint in the Vitale action. The plaintiff also alleges that his failure to make a demand on the Board prior to filing the action is excused as futile.
The Company sought to transfer the Keene action to the United States District Court for the Eastern District of Pennsylvania as part of the MDL Motion. On January 21, 2006, the court stayed the Keene action pending resolution of the MDL Motion. On February 23, 2006, the Keene action was transferred with the Federal Securities Actions from the Southern District of Texas to the Eastern District of Pennsylvania. Thereafter, on May 15, 2006, the plaintiff filed an amended complaint, and on June 5, 2006, the defendants moved to dismiss the amended complaint. On August 21, 2006, the plaintiff moved for leave to file a second amended complaint, and on September 15, 2006, defendants filed an opposition to that motion. On January 24, 2007, the court denied the plaintiff’s motion to file a second amended complaint, and on April 10, 2007 the court granted the defendants’ motion to dismiss and dismissed the amended complaint without prejudice. On May 9, 2007, plaintiff filed a notice of appeal from the January 24, 2007 order denying plaintiff’s motion to file a second amended complaint, and from the April 10, 2007 order dismissing plaintiff’s amended complaint without prejudice. The appeal is fully briefed. On or about April 5, 2008, Keene moved the appeals court to stay the appeal for a period of 90 days to permit Keene to participate in the mediation of the federal securities litigation (described above) and the Beattie derivative litigation (described below). The mediation is described under “Federal Securities Litigation” above.
On October 31, 2005, William Thomas Fordyce filed an action styled, C.A. No. GD-05-08432, William Thomas Fordyce v. Frank M. DeLape, et al., in the Court of Common Pleas of Chester County, Pennsylvania. This action makes substantially similar allegations as the original complaint in the Vitale action. The plaintiff also alleges that his failure to make a demand on the Board prior to filing the action is excused as futile.
On January 20, 2006, the Company filed its preliminary objections to the complaint. On August 31, 2006, the Court of Common Pleas entered an opinion and order sustaining the preliminary objections and dismissing the complaint with prejudice. On September 19, 2006, Fordyce filed a motion for reconsideration, which the Court of Common Pleas denied. On September 28, 2006, Fordyce filed a notice of appeal to the Superior Court of Pennsylvania. On July 27, 2007, the Superior Court affirmed the decision of the Court of Common Pleas.
On February 14, 2008, Ronald Beattie filed an action styled C.A. No. 08-724, Ronald Beattie v. Michael Macaluso, et al., in the United States District Court for the Eastern District of Pennsylvania. This action makes substantially similar allegations as the original complaint in the Vitale action.
On April 1, 2008, the court entered an order extending the defendants’ time to respond to the complaint for a period ending 150 days from April 1, 2008 and directing the parties, together with the parties to the federal securities litigation described above, to mediation before a private mediator. The mediation is described under “Federal Securities Litigation” above.
The Derivative Actions are purportedly being prosecuted on behalf of the Company and any recovery obtained, less any attorneys’ fees awarded, will inure to the benefit of the Company. The Company is advancing legal expenses to certain current and former directors and officers of the Company who are named as defendants in the Derivative Actions and expects to receive reimbursement for those advances from its insurance carriers. The Company will expense its legal costs as they are incurred and will record any insurance recoveries on such legal costs in the period the recoveries are received. The Company cannot currently estimate the amount of loss, if any, that may result from the resolution of these actions, and no provision has been recorded in the consolidated financial statements.

 

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Indemnity Demands
Mr. Jeffrey Tomz
After the above referenced litigations were commenced, Mr. Jeffrey Tomz, who formerly served as Isolagen’s Chief Financial Officer, demanded reimbursement of his costs of defense, and reimbursement for the costs of responding to a Securities and Exchange Commission investigation of his alleged insider trading in Isolagen stock. It is understood that Mr. Tomz’s defense costs to date amount to approximately $0.3 million.
As the Vitale matter has now been resolved in favor of all defendants, including Mr. Tomz, the Company is presently obligated to reimburse him for the reasonable and necessary costs of defending all claims asserted therein other than the insider trading allegations. Although decided on jurisdictional grounds, it is likely the Company is also obligated to reimburse Mr. Tomz for the reasonable and necessary costs incurred in defending the Fordyce matter given that it has also been resolved in favor of all defendants. The Company would be liable to reimburse Mr. Tomz for the reasonable and necessary costs of defense in the Keene case if it is affirmed on appeal and in the putative securities cases should he prevail in that action. The Company has refused to pay the amount of fees and expenses for which Mr. Tomz has sought reimbursement because it believes they are excessive, duplicative and have not been properly segregated between reimbursable and non-reimbursable claims. The Company has negotiated an acceptable compromise for the amounts billed by Mr. Tomz’s local Pennsylvania counsel for an amount less than $0.1 million.
Prior to the resolution of the various derivative actions, Mr. Tomz filed a demand for arbitration seeking advancement of his defense costs. He subsequently agreed to stay those proceedings. At present, Mr. Tomz has not sought to lift this stay and it is uncertain whether he will attempt to do so in the future.
The Company has accrued less than $0.1 million in the accompanying Consolidated Financial Statements as of June 30, 2008 with respect to Mr. Tomz’s existing defense costs in dispute. The Company intends to seek reimbursement under its directors and officers liability policy for any amounts paid to reimburse Mr. Tomz for his defense costs, which includes less than $0.1 million paid to date.
Underwriters
The Underwriters have each demanded that the Company indemnify, hold harmless and defend them with respect to the claims asserted in the putative securities actions. The total amount demanded to date is approximately $0.8 million, and the total future amount cannot be estimated at this time. The Underwriters demands for indemnification are a subject of the ongoing mediation efforts described under “Federal Securities Litigation” above.
Isolagen has denied this demand on numerous grounds, including that: (i) as to the November 2004 convertible notes offering, it only agreed to indemnify the Underwriters for any losses resulting from any untrue statement, or alleged untrue statement, of material fact in the offering documents provided by the Company to a holder or prospective purchaser of securities, and plaintiffs’ claims in the securities action are not based upon alleged untrue statements in any such documents; (ii) as to the June 2004 secondary offering, it only agreed to indemnify the Underwriters for untrue statements, or alleged untrue statements, of material fact, in the preliminary prospectus, registration statement, prospectus or any amendment thereof, and the Company believes there were no such untrue statements in any such document; (iii) Isolagen assumed no duty to defend or advance defense costs; and (iv) Isolagen satisfied whatever duty to defend it may have to the Underwriters by offering to assume the Underwriters’ defense. Accordingly, the Company has not accrued any amounts related to the Underwriters’ defense costs in its Consolidated Financial Statements.
Dispute with Former President and Member of the Board of Directors
On March 16, 2007, the Company disclosed in its Form 10-K for the year ended December 31, 2006 (the “Form 10-K”), that the Company and Susan Ciallella had reached an understanding pursuant to which Ms. Ciallella would resign from the Company in all capacities. The understanding, which was described in the Form 10-K, was subject to the negotiation and execution of a definitive agreement. On May 10, 2007, the Company disclosed in its Form 10-Q for the quarter ended March 31, 2007, that no such definitive agreement had been concluded with Ms. Ciallella, and that Ms. Ciallella was asserting claims against the Company in connection with her separation from the Company. On June 8, 2007, the Company and Ms. Ciallella participated in a voluntary mediation before a former federal judge. Upon conclusion of the mediation, the Company and Ms. Ciallella entered into a Settlement Agreement and Release (the “Settlement Agreement”) pursuant to which the parties agreed to settle and resolve all claims that Ms. Ciallella may have against the Company as well as all aspects of Ms. Ciallella’s separation from the Company. The Settlement Agreement provided Ms. Ciallella the following:
(i) severance payments as follows: (a) $450,000, which was paid by June 2007; (b) $240,000 paid on September 17, 2007; and (c) $40,000 per month to be paid each month beginning October 17, 2007 through July 15, 2008 with a $20,000 payment to be made on July 30, 2008;
(ii) $1,745,000, which was paid during June 2007 in satisfaction and settlement of Ms. Ciallella’s legal claims relating to her termination;

 

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(iii) $5,000 paid during June 2007 in connection with Ms. Ciallella’s release of claims under the Age Discrimination in Employment Act;
(iv) $159,245 paid during June 2007 for the reimbursement of Ms. Ciallella’s legal fees in connection with the negotiation and execution of the Settlement Agreement;
(v) $198,950 related to Ms. Ciallella’s legal support services to be provided to the Company, of which approximately $158,000 had been paid as of December 31, 2007;
(vi) Ms. Ciallella retained 300,000 of the 400,000 performance options issued to her in June 2006, which expire in June 2016; Ms. Ciallella retained 160,000 of the options issued to her in April 2006, which expire in April 2016 and which were fully vested; and Ms. Ciallella retained her vested 300,000 options, which were issued to her in April 2005 and expire in April 2015 (see Note 8).
Each of the Company and Ms. Ciallella released the other party from any and all claims that it/she may have; and Ms. Ciallella agreed to resign from all officer and director positions she held with the Company or any of its subsidiaries.
During the three months ended March 31, 2007, the Company recorded termination costs aggregating $2.6 million to reflect the March 16, 2007 understanding between the parties, which were included in selling, general, and administrative expenses. As a result of the June 2007 Settlement Agreement, during the three months ended June 30, 2007 the Company recorded an additional $2.0 million of termination costs, which are also included in selling, general, and administrative expenses. No such expenses were incurred subsequent to June 30, 2007. Accordingly, for the three months ended March 31, 2007, three months ended June 30, 2007 and for the six months ended June 30, 2007, the Company recorded total termination costs of approximately $4.6 million, as follows:
                         
    Three months ended     Three months ended     Six months ended  
(in millions)   March 31, 2007     June 30, 2007     June 30, 2007  
Salary and severance
  $ 1.2     $ 1.6     $ 2.8  
Consulting fee
    0.3       (0.1 )     0.2  
Legal fee reimbursement to Ms. Ciallella
          0.2       0.2  
Company legal fees
          0.3       0.3  
Stock option modifications (see Note 8)
    1.1             1.1  
 
                 
 
  $ 2.6     $ 2.0     $ 4.6  
 
                 
Of the $0.3 million of Company legal fees above, approximately $133,000 related to the Board of Directors’ Special Committee legal counsel retained in connection with the Ciallella matter and was paid directly by the Company. Less than $10,000 related to the legal fees of one the Company’s Board members in connection with the Ciallella matter was paid directly by the Company. Also, less than $10,000 related to the legal fees of the Company’s Chief Executive Officer in connection with the Ciallella matter was paid directly by the Company. The Company is pursuing reimbursement of the amounts paid in excess of Ms. Ciallella’s contractual severance, plus defense costs, from its insurance carriers. There can be, however, no assurance that there will be a recovery or if there is, of the amount thereof. As of June 30, 2008, $0.1 million remains due to Ms. Ciallella and is recorded in accrued expenses on the consolidated balance sheet.

 

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United Kingdom Customer Settlement
During 2005, the Company began an informal study and surveyed a number of patients who had previously received the Isolagen treatment to assess patient satisfaction. Some patients surveyed reported sub-optimal results from treatment. One hundred forty-nine patients who claimed to have received sub-optimal results were retreated for the purpose of determining the reasons for sub-optimal results. Only those patients who completed the survey, provided adequate medical records including before and after photographs and who were deemed both to have received a sub-optimal result from a first treatment administered according to the Isolagen protocol and who were considered to be appropriate patients for treatment with the Isolagen Therapy received re-treatment. No one completing the survey was offered re-treatment unless they agreed to these conditions. Following re-treatment, a number of patients reported better results than first obtained through the initial treatment by their initial treating physician.
During the first quarter of 2006, the Company received a number of complaints from certain patients who had learned of the limited re-treatment program and also learned that a number of physicians with dissatisfied patients were generating public ill-will as a result of the Company’s decision to limit the number of patients offered re-treatment and were encouraging dissatisfied patients to seek recourse against the Company. In response, in March 2006 the Company decided that it was in its best interest to address these complaints to foster goodwill in the marketplace and avoid the cost of any potential patient claims. Accordingly, the Company agreed to resolve any properly documented and substantiated patient complaints by offering to retreat the patient pursuant to the same criteria stated above or pay £1,000 (approximately US$1,750) to the patients identified to the Company as having received a sub-optimal result. In order to qualify for re-treatment and in addition to the criteria set forth above, the patient will be treated by a physician identified by the Company who will treat these patients pursuant to a protocol. In addition, these patients must have agreed to follow-up visits and assessments of their response to treatment. No patient unlikely to benefit from Isolagen Therapy has been or will be retreated.
The Company made this offer to approximately 290 patients during late March 2006. Accordingly, the Company believed its range of liability was between £290,000 (or approximately $0.5 million), assuming all 290 patients were to choose the £1,000 payment, and approximately £580,000 (or approximately $1.0 million), assuming all 290 patients elected to be retreated. The estimated costs for retreatment include the cost of treatment, physician fees and other ancillary costs. The Company estimated that 60% of the patients would elect the £1,000 offer and 40% would elect to be retreated. Accordingly, the Company recorded a charge reflected under loss from discontinued operations for the three months ended March 31, 2006 of $0.7 million. During the three months ended June 30, 2006, an additional 31 patients were entered into the settlement program, resulting in an additional charge reflected under loss from discontinued operations of $0.1 million.
During the year ended December 31, 2006, payments to patients and retreatments reduced the accrual by $0.6 million. During the three months ended March 31, 2007 and June 30, 2007, payments and retreatments to patients reduced the accrual by approximately $0.1 million and $0.0 million, respectively. As of June 30, 2008, the accrual, which is included in current liabilities of discontinued operations in the consolidated balance sheet, was $0.1 million. The estimates related to this liability may change in future periods and the effects of any changes will be accounted for in the period in which the estimate changes.
U nited Kingdom Claims
Subsequent to the Company’s public announcement regarding the closure of the United Kingdom operation, the Company received negative publicity and negative correspondence from former patients in the United Kingdom that previously received the Company’s treatment. More recently, the Company received a written demand by an attorney representing approximately 114 former patients, as of June 30, 2008, each claiming negligent misstatements were made and each claiming, on average, £3,500 (or approximately $7,000), plus unquantified interest and incidental expenses. The Company has responded to the written demand and is in the process of evaluating the merits of the claims. To date, no formal legal action has been brought by the attorney against the Company, and no provision has been recorded in the consolidated financial statements related to this matter.
Other Litigation
The Company is involved in various other legal matters that are being defended and handled in the ordinary course of business. Although it is not possible to predict the outcome of these other matters, management currently believes that the results will not have a material impact on the Company’s financial statements.

 

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American Stock Exchange Noncompliance
On March 12, 2008, the Company received a notice from the American Stock Exchange (AMEX) advising the Company that it does not meet certain of the continued listing standards as set forth in Part 10 of the AMEX Company Guide. AMEX notified the Company that it was not in compliance with Sections 1003 (a)(i)-(iii) of the AMEX Company Guide. Specifically, the AMEX staff noted that the Company’s stockholder’s equity was less than $2,000,000 and losses from continuing operations and net losses were incurred in two out of its three most recent fiscal years; that the Company’s stockholder’s equity was less than $4,000,000 and losses from continuing operations and/or net losses were incurred in three out of its four most recent fiscal years; and that the Company’s stockholder’s equity was less than $6,000,000 and losses from continuing operations and/or net losses were incurred in its five most recent fiscal years.
The Company submitted a plan to AMEX on April 14, 2008 that outlined the Company’s strategy to bring itself back into compliance by September 14, 2009. The plan was not accepted by AMEX, and as such, the Company is subject to delisting procedures as set forth in Section 1010 and Part 12 of the Amex Company Guide. Under AMEX rules, the Company has the right to appeal any determination by AMEX to initiate delisting proceedings. The Company has appealed the determination and the Company will present its appeal to AMEX at a hearing scheduled for August 19, 2008. There can be no assurance that the Company’s request for continued listing will be granted after such hearing.
Note 8—Equity-based Compensation
In December 2004, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 123 (revised 2004), “Share-Based Payment” (“SFAS No. 123(R)”). SFAS No. 123(R) replaced SFAS No. 123, “Accounting for Stock-Based Compensation”, superseded APB Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB No. 25”), and amended SFAS No. 95, “Statement of Cash Flows.” SFAS No. 123(R) requires entities to recognize compensation expense for all share-based payments to employees and directors, including grants of employee stock options, based on the grant-date fair value of those share-based payments, adjusted for expected forfeitures. Further, compensation expense is recognized in connection with the issuance of stock options to non-employee consultants in accordance with EITF 96-18, “Accounting for Equity Instruments That are Issued to Other than Employees for Acquiring, or in Conjunction with Selling Goods and Services.”
The Company utilizes the straight-line attribution method for recognizing stock-based compensation expense under SFAS No. 123(R). The Company recorded $0.2 million and $0.5 million of compensation expense, net of tax, during the three months ended June 30, 2008 and June 30, 2007, respectively, for stock option awards to employees and directors based on the estimated fair values, at the grant dates, of the awards. The Company recorded $0.4 million and $0.9 million of compensation expense, net of tax, during the six months ended June 30, 2008 and June 30, 2007, respectively, for stock option awards to employees and directors based on the estimated fair values, at the grant dates, of the awards. Further, in connection with the departure of the Company’s former Chief Executive Officer and former President, and the related modification of the former Chief Executive Officer and President’s stock options, the Company recorded $1.3 million and $1.1 million in stock option modification expense during the three months ended March 31, 2008 and March 31, 2007, respectively, as discussed further below under Modification of Stock Options. No such stock option modifications occurred during the three months ended June 30, 2008 or three months ended June 30, 2007.

 

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The weighted average fair market value using the Black-Scholes option-pricing model of the options granted was $0.92 and $1.92 for the six months ended June 30, 2008 and 2007, respectively. The fair market value of the stock options at the date of grant was estimated using the Black-Scholes option-pricing model with the following weighted average assumptions:
                 
    Six Months Ended June 30,  
    2008     2007  
Expected life (years)
  5.8 years     4.2 years  
Interest rate
    2.9 %     4.9 %
Dividend yield
           
Volatility
    92 %     77 %
The risk-free interest rate is based on U.S. Treasury interest rates at the time of the grant whose term is consistent with the expected life of the stock options. Expected volatility is based on the Company’s historical experience. Expected life represents the period of time that options are expected to be outstanding and is based on the Company’s historical experience or the simplified method, as permitted by SEC Staff Accounting Bulletin No. 107 where appropriate. Expected dividend yield was not considered in the option pricing formula since the Company does not pay dividends and has no current plans to do so in the future. The forfeiture rate used was based upon historical experience. As required by SFAS No. 123(R), the Company will adjust the estimated forfeiture rate based upon actual experience.
During December 2005, the Company’s Board of Directors approved the full vesting of all unvested, outstanding stock options issued to current employees and directors. The Board decided to take this action (“the acceleration event”) in anticipation of the adoption of SFAS No. 123(R). As a result of this acceleration event, approximately 1.4 million stock options were vested that would have otherwise vested during 2006 and later periods. At the time of the acceleration event, the unamortized grant date fair value of the affected options was approximately $3.6 million (for SFAS No. 123 and SFAS No. 148 pro forma disclosure purposes), which was charged to pro forma expense in the fourth quarter of 2005. As the Company accelerated the vesting of outstanding employee and director stock options during December 2005, there was no remaining expense related to such options to be recognized in the Company’s statements of operations in future periods.
There were no stock options exercised during the six months ended June 30, 2008. There were 0 and 15,000 stock options exercised during the three and six months ended June 30, 2007, respectively, resulting in cash proceeds to the Company of $0 and $23,100, respectively. The options exercised had an intrinsic value of $15,900. The following table summarizes option activity for the six months ended June 30, 2008:
                                 
                    Weighted        
            Weighted     Average        
            Average     Remaining     Aggregate  
            Exercise     Contractual     Intrinsic  
Options   Shares     Price     Term     Value  
 
                               
Outstanding at January 1, 2008
    7,723,999     $ 3.45                  
Six months ended June 30, 2008:
                               
Granted
    1,132,000       1.27                  
Exercised
                           
Forfeited
    (225,833 )     3.80                  
 
                             
Outstanding at June 30, 2008
    8,630,166     $ 3.16     $ 5.68     $  
 
                       
Options exercisable at June 30, 2008
    5,865,162     $ 3.79     $ 4.96     $  
 
                       
The following table summarizes non-vested stock option activity for the six months ended June 30, 2008:
                 
    Non-vested Options  
            Weighted-  
    Number of     Average Fair  
    Shares     Value  
Non-vested at January 1, 2008
    2,546,838     $ 1.43  
Granted
    1,132,000       0.92  
Vested
    (731,334 )     1.22  
Forfeited
    (182,500 )     2.07  
 
             
Non-vested at June 30, 2008
    2,765,004     $ 1.24  
 
             

 

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The total fair value of shares vested during the six months ended June 30, 2008 and June 30, 2007 was $0.9 million and $1.3 million, respectively. As of June 30, 2008 and December 31, 2007, there was $1.1 million and $1.8 million of total unrecognized compensation cost, respectively, related to non-vested director and employee stock options which vest over time (excluding stock options measured pursuant to EITF 96-18, see Modification of Stock Options further below). That cost is expected to be recognized over a weighted-average period of 2.0 years. As of June 30, 2008 and December 31, 2007, there was $0.3 million and $0.8 million, respectively, of total unrecognized compensation cost related to performance-based, non-vested employee stock options. That cost will begin to be recognized when the performance criteria within the respective performance-base option grants become probable of achievement.
2001 Stock Option and Stock Appreciation Rights Plan
Effective August 10, 2001, the Company adopted the Isolagen, Inc. 2001 Stock Option and Stock Appreciation Rights Plan (the “2001 Stock Plan”). The 2001 Stock Plan is discretionary and allows for an aggregate of up to 5,000,000 shares of the Company’s common stock to be awarded through incentive and non-qualified stock options and stock appreciation rights. The 2001 Stock Plan is administered by the Company’s Board of Directors, who has exclusive discretion to select participants who will receive the awards and to determine the type, size and terms of each award granted. As of June 30, 2008, there were 2,933,500 options outstanding under the Stock Plan and 1,440,834 options were available to be issued under the Stock Plan.
During the three months ended March 31, 2008, the Company issued under the 2001 Stock Plan the following ten-year life option grants to Mr. Declan Daly, Chief Executive Officer: (a) an option to purchase 350,000 shares of common stock at an exercise price of $2.36, which vests in twelve equal quarterly installments commencing March 31, 2008; and (b) a performance stock option to purchase 100,000 shares of common stock at an exercise price of $2.36 that shall vest as follows: (i) 50% of performance stock option shall vest upon the Company’s accepted filing of a Biologics License Application by the FDA and (ii) the remaining 50% of the performance stock option shall vest upon the FDA’s approval of the Company’s Biologics License Application filing; provided in each case that Mr. Daly is the Company’s Chief Executive Officer at the time of said event.
Further, during the three months ended March 31, 2008, the following options grants were issued: (1) options issued to nine employees to purchase a total of 102,000 shares of common stock at an exercise price of $0.61, which vest in equal annual installments over three years and have a five year life, (2) an option issued to the Company’s Chief Financial Officer to purchase 200,000 shares of common stock at an exercise price of $0.48, which vests in equal annual installments over three years and have a ten year life and (3) performance options issued to two consultants to purchase 200,000 shares of common stock at an average exercise price of $0.51 (or exercise price range of $0.41 to $0.61), which vest upon the attainment of certain performance criteria. No compensation cost has been recorded for the performance stock option grants as the Company does not currently believe that the vesting events are probable of occurrence. A total of 952,000 stock options were granted during the three months ended March 31, 2008 under the 2001 Stock Plan.
The grant date fair value of the employee performance option awards issued during the three months ended March 31, 2008 was approximately $0.2 million. This fair value of $0.2 million, or any portion thereof, will not be recognized as compensation expense until the vesting of the award becomes probable. The fair value of the total non-employee performance awards issued during the three months ended March 31, 2008 was less than $0.1 million as of March 31, 2008. Compensation expense related to the non-employee performance option awards will not be recognized until vesting of the awards occur, and the actual amount of expense will be based upon the valuation factors in effect at that time.
During the three months ended March 31, 2007, the Company issued, under the 2001 Stock Plan, 395,000 options to employees and Board of Director members, with exercise prices ranging from $2.37 to $3.10 and with contractual lives of 5 years for employees and 10 years for Board members. During the three months ended June 30, 2007, the Company issued, under the 2001 Stock Plan, 140,000 options to three employees, with exercise prices ranging from $4.20 to $4.55 and with contractual lives of 5 years.

 

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During the three months ended June 30, 2008, the company issued to its six independent Board of Director members, under the 2001 Stock Plan, a total of 180,000 options to purchase its common stock with an exercise price of $0.62 per share and a ten year maximum contractual life. The options vest one-fourth upon grant and one-fourth over the three remaining fiscal quarters of 2008.
2003 Stock Option and Stock Appreciation Rights Plan
On January 29, 2003, the Company’s Board of Directors approved the 2003 Stock Option and Appreciation Rights Plan (the “2003 Stock Plan”). The 2003 Stock Plan is discretionary and allows for an aggregate of up to 2,250,000 shares of the Company’s common stock to be awarded through incentive and non-qualified stock options and stock appreciation rights. The 2003 Stock Plan is administered by the Company’s Board of Directors, who has exclusive discretion to select participants who will receive the awards and to determine the type, size and terms of each award granted. As of June 30, 2008, there were 1,823,333 options outstanding under the 2003 Stock Plan and 426,667 shares were available for issuance under the 2003 Stock Plan. No options have been granted under the 2003 Stock Plan since November 2006.
2005 Equity Incentive Plan
On April 26, 2005, the Company’s Board of Directors approved the 2005 Equity Incentive Plan (the “2005 Stock Plan”). The 2005 Stock Plan is discretionary and allows for an aggregate of up to 2,100,000 shares of the Company’s common stock to be awarded through incentive and non-qualified stock options, stock units, stock awards, stock appreciation rights and other stock-based awards. The 2005 Stock Plan is administered by the Compensation Committee of the Company’s Board of Directors, who has exclusive discretion to select participants who will receive the awards and to determine the type, size and terms of each award granted. As of June 30, 2008, there were 305,000 options outstanding and 1,712,818 shares were available for issuance under the 2005 Stock Plan. No options have been granted under the 2005 Stock Plan since June 2006.
During the three months ended March 31, 2007, the Company modified a 400,000 share performance option grant, as discussed below under Modification of Stock Options. This 400,000 share performance option grant was issued during the three months ended June 30, 2006 to purchase common stock with an exercise price of $1.88 per share to the Company’s former President. These options had a ten year maximum contractual life and the options were to vest, and no longer be subject to forfeiture, upon the occurrence of any of the following events: (i) upon the closing of the sale of substantially all of the assets of the Company or the reorganization, consolidation or the merger of the Company; provided that the event results in the payment or distribution of consideration valued in good faith by the Board of Directors at $25 per share or more; or (ii) upon the closing of a tender offer or exchange offer to purchase 50% or more of the issued and outstanding shares of common stock of the Company at a price per share valued in good faith by the Board of Directors at $25 or more; or (iii) immediately following a “Stock Acquisition Date,” as that term is defined in the Rights Plan adopted by the Company on May 12, 2006 (provided that said rights are not subsequently redeemed by the Company or that the Rights Plan is not subsequently amended to preclude exercise of the rights issued thereunder, prior to the Distribution Date, as that term is defined in the Rights Pan), or (iv) at such other time as the Board of Directors, in its sole discretion, deems appropriate; provided in each case that the President is employed by the Company at the time of said event. The 400,000 share option grant was considered a grant of a performance stock option. No compensation cost was recorded during 2006 for this grant as the Company did not believe that the vesting events were probable of occurrence. The 2006 grant date fair value of the award was approximately $0.6 million. Subsequently, this 400,000 share option grant was modified during the three months ended March 31, 2007, as discussed below under Modification of Stock Options.
Other Stock Options
The Company has not issued any options outside the 2001 Stock Plan, the 2003 Stock Plan or the 2005 Stock Plan since June 2006. As of June 30, 2008, there were 3,568,333 nonqualified stock options outstanding outside of the shareholder approved plans discussed above.

 

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Modification of Stock Options
On January 7, 2008, the Company and Mr. Nicholas L. Teti, Jr. entered into a consulting and non-competition agreement (the “Consulting Agreement”), pursuant to which Mr. Teti agreed to continue as the Company’s non-executive Chairman of the Board and to become a consultant to the Company, and Mr. Teti resigned his position as Chief Executive Officer and President of the Company. Pursuant to the Consulting Agreement, Mr. Teti’s original employment agreement, dated June 5, 2006, was terminated and the parties agreed that he was owed no severance payments under the original employment agreement. Mr. Teti retained his previously issued stock options which were modified such that Mr. Teti will continue to vest in accordance with the original terms, except as a non-employee. As a result of the modifications to Mr. Teti’s stock options set forth in the Consulting Agreement, the Company recorded a non-cash compensation charge during the three months ended March 31, 2008 of approximately $1.3 million related to Mr. Teti’s 1,166,665 vested stock options on the date of modification.
Further, stock compensation expense relating to the 833,335 unvested stock options Mr. Teti held at the time of modification will be recorded as stock option expense over the remaining periods those stock options are earned in accordance with EITF 96-18, “Accounting for Equity Instruments That are Issued to Other than Employees for Acquiring, or in Conjunction with Selling Goods and Services.” These stock options vest ratably through June 30, 2009.
In connection with the separation of the Company’s former President (see Note 7), the Company agreed on March 16, 2007 to modify certain of her stock options such that (1) 120,000 unvested, time-based stock options would vest immediately and (2) of 400,000 performance based stock options, 100,000 would be cancelled and the remaining 300,000 would be extended such that the 300,000 options would expire 10 years from the original grant date, as opposed to expiring upon termination of employment. The 300,000 performance based stock options would continue to be subject to the same performance based vesting requirements. The 120,000 modified stock options were valued using the Black-Scholes valuation model, and resulted in $0.3 million charge to selling, general and administrative expense during the months ended March 31, 2007. The 300,000 modified performance stock options were valued using the Black-Scholes valuation model, and resulted in $0.8 million charge to selling, general and administrative expense in the year ended December 31, 2007.
Equity Instruments Issued for Services
As of June 30, 2008, the Company had outstanding 1,436,935 warrants and options issued to non-employees under consulting agreements, including the 833,335 options related to Mr. Teti, the Company’s former CEO, which were unvested at the time of modification, as discussed above. The following sets forth certain information concerning these warrants and options:
     
    Vested
Warrants and options outstanding
  936,934
Range of exercise prices
  $1.50—6.00
Weighted average exercise price
  $3.36
Expiration dates
  2009—2016
     
    Unvested
Warrants and options outstanding
  500,001
Range of exercise prices
  $1.88
Weighted average exercise price
  $1.88
Expiration dates
  2016

 

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All of the above unvested equity instruments relate to the Company’s former Chief Executive Officer, as of June 30, 2008. Expense related to these contracts was less than $0.1 million in each three month period ended June 30, 2008 and 2007. Expense related to these contracts was $0.1 million and less than $0.1 million in the six month period ended June 30, 2008 and 2007. This expense, which is in addition to the stock option expense related to employees and directors based on the grant date fair value discussed above, was calculated using the Black Scholes option-pricing model based on the following assumptions:
     
Expected life (years)
  4—4.3 Years
Interest rate
  3.0—3.13%
Dividend yield
 
Volatility
  100—106%
Further, there were 168,246 warrants outstanding as of June 30, 2008 and December 31, 2007, which were primarily issued in connection with past equity offerings.
Note 9—Segment Information and Geographical information
With the acquisition of Agera on August 10, 2006 (see Note 4), the Company now has two reportable segments: Isolagen Therapy and Agera. Prior to the acquisition of Agera, the Company reported one reportable segment. The Isolagen 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. The following table provides operating financial information for the continuing operations of the Company’s two reportable segments:
                         
    Segment        
    Isolagen              
    Therapy     Agera     Consolidated  
Three Months Ended June 30, 2008
                       
External revenue
  $     $ 271,721     $ 271,721  
Intersegment revenue
                 
 
                 
Total operating revenue
          271,721       271,721  
Cost of revenue
          147,787       147,787  
Selling, general and administrative expense
    2,036,668       174,894       2,211,562  
Research and development expense
    3,251,355             3,251,355  
Management fee
    (69,000 )     69,000        
 
                 
Total operating expenses
    5,219,023       243,894       5,462,917  
 
                 
Operating loss
    (5,219,023 )     (119,960 )     (5,338,983 )
Interest income
    46,879       7       46,886  
Other income
                 
Interest expense
    (974,810 )           (974,810 )
Minority interest
          21,910       21,910  
 
                 
Segment loss from continuing operations
  $ (6,146,954 )   $ (98,043 )   $ (6,244,997 )
 
                 
 
                       
Six Months Ended June 30, 2008
                       
External revenue
  $     $ 489,674     $ 489,674  
Intersegment revenue
                 
 
                 
Total operating revenue
          489,674       489,674  
Cost of revenue
          318,762       318,762  
Selling, general and administrative expense
    5,844,777       311,623       6,156,400  
Research and development expense
    6,145,211             6,145,211  
Management fee
    (219,000 )     219,000        
 
                 
Total operating expenses
    11,770,988       530,623       12,301,611  
 
                 
Operating loss
    (11,770,988 )     (359,711 )     (12,130,699 )
Interest income
    133,493       25       133,518  
Other income
                 
Interest expense
    (1,949,620 )           (1,949,620 )
Minority interest
          60,495       60,495  
 
                 
Segment loss from continuing operations
  $ (13,587,115 )   $ (299,191 )   $ (13,886,306 )
 
                 

 

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Supplemental information:
                         
    Segment        
    Isolagen              
For the three months ended June 30, 2008 and as of June 30, 2008:   Therapy     Agera     Consolidated  
Depreciation and amortization expense
  $ 270,510     $ 81,711     $ 352,221  
Capital expenditures
    13,013             13,013  
Equity awards issued for services
    256,452             256,452  
Amortization of debt issuance costs
    187,310             187,310  
Total assets, including assets from discontinued operations, June 30, 2008
    16,371,793       4,931,948       21,303,741  
Property and equipment, June 30, 2008
    2,858,108             2,858,108  
Intangible assets, net, June 30, 2008
    525,937       3,906,244       4,432,181  
Supplemental information:
                         
    Segment        
    Isolagen              
For the six months ended June 30, 2008:   Therapy     Agera     Consolidated  
Depreciation and amortization expense
  $ 556,343     $ 163,419     $ 719,762  
Capital expenditures
    29,892             29,892  
Equity awards issued for services
    1,715,420             1,715,420  
Amortization of debt issuance costs
    374,619             374,619  
An intercompany receivable of $1.0 million, due from the Agera segment to the Isolagen Therapy segment as of June 30, 2008, is eliminated in consolidation. This intercompany receivable is primarily due to the intercompany management fee charge to Agera by Isolagen, as well as Agera working capital needs provided by Isolagen, and has been excluded from total assets of the Isolagen Therapy segment in the above table. Total assets on the consolidated balance sheet at June 30, 2008 are approximately $21.3 million, which includes assets of continuing operations of $21.1 million and assets of discontinued operations of $0.2 million.
                         
    Segment        
    Isolagen              
    Therapy     Agera     Consolidated  
Three months ended June 30, 2007
                       
External revenue
  $     $ 346,716     $ 346,716  
Intersegment revenue
                 
 
                 
Total operating revenue
          346,716       346,716  
Cost of revenue
          157,373       157,373  
Selling, general and administrative expense
    5,193,263       513,262       5,706,525  
Research and development expense
    3,365,412       6,620       3,372,032  
Management fee
    (150,000 )     150,000        
 
                 
Total operating expenses
    8,408,675       669,882       9,078,557  
 
                 
Operating loss
    (8,408,675 )     (480,539 )     (8,889,214 )
Interest income and other
    299,872       197       300,069  
Interest expense
    (974,810 )           (974,810 )
Minority interest
          142,047       142,047  
 
                 
Segment loss from continuing operations
  $ (9,083,613 )   $ (338,295 )   $ (9,421,908 )
 
                 

 

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    Segment        
    Isolagen              
    Therapy     Agera     Consolidated  
Six months ended June 30, 2007
                       
External revenue
  $     $ 660,338     $ 660,338  
Intersegment revenue
                 
 
                 
Total operating revenue
          660,338       660,338  
Cost of revenue
          316,460       316,460  
Selling, general and administrative expense
    11,151,279       892,551       12,043,830  
Research and development expense
    6,444,721       16,382       6,461,103  
Management fee
    (300,000 )     300,000        
 
                 
Total operating expenses
    17,296,000       1,208,933       18,504,933  
 
                 
Operating loss
    (17,296,000 )     (865,055 )     (18,161,055 )
Interest income and other
    595,347       3,472       598,819  
Interest expense
    (1,949,620 )           (1,949,620 )
Minority interest
          241,481       241,481  
 
                 
Segment loss from continuing operations
  $ (18,650,273 )   $ (620,102 )   $ (19,270,375 )
 
                 
Supplemental information:
                         
    Segment        
    Isolagen              
For the three months ended June 30, 2007 and as of December 31, 2007:   Therapy     Agera     Consolidated  
Depreciation and amortization expense
  $ 298,218     $ 81,709     $ 379,927  
Capital expenditures
    82,968             82,968  
Equity awards issued for services
    502,431             502,431  
Amortization of debt issuance costs
    187,310             187,310  
Total assets, including assets from discontinued operations, as of December 31, 2007
    34,162,693       5,328,497       39,491,190  
Property and equipment, net, as of December 31, 2007
    3,395,723             3,395,723  
Intangible assets, net, as of December 31, 2007
    529,875       4,069,663       4,599,538  
Supplemental information:
                         
    Segment        
    Isolagen              
For the six months ended June 30, 2007:   Therapy     Agera     Consolidated  
Depreciation and amortization expense
  $ 596,505     $ 163,420     $ 759,925  
Capital expenditures
    97,780             97,780  
Equity awards issued for services and equity award modifications
    2,168,812             2,168,812  
Amortization of debt issuance costs
    374,620             374,620  
An intercompany receivable of $1.1 million, due from the Agera segment to the Isolagen Therapy segment as of December 31, 2007, is eliminated in consolidation. This intercompany receivable is primarily due to the intercompany management fee charge to Agera by Isolagen and has been excluded from total assets of the Isolagen Therapy segment in the above table. Total assets on the consolidated balance sheet at December 31, 2007 are approximately $39.5 million, which includes assets of continuing operations of $28.2 million and assets of discontinued operations of $11.3 million.

 

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Geographical information concerning the Company’s operations and assets is as follows:
                 
    Revenue  
    Three months ended June 30,  
    2008     2007  
United States
  $ 82,325     $ 79,184  
United Kingdom
    163,810       262,854  
Other
    25,586       4,678  
 
           
 
  $ 271,721     $ 346,716  
 
           
                 
    Revenue  
    Six months ended June 30,  
    2008     2007  
United States
  $ 179,605     $ 203,275  
United Kingdom
    271,320       435,596  
Other
    38,749       21,467  
 
           
 
  $ 489,674     $ 660,338  
 
           
                 
    Property and Equipment, net  
    June 30,     December 31,  
    2008     2007  
United States
  $ 2,858,108     $ 3,395,723  
 
           
 
  $ 2,858,108     $ 3,395,723  
 
           
                 
    Intangible Assets, net  
    June 30,     December 31,  
    2008     2007  
United States
  $ 4,432,181     $ 4,599,538  
 
           
 
  $ 4,432,181     $ 4,599,538  
 
           
During the three months ended June 30, 2008 revenue from one foreign customer and one domestic customer represented 60% and 22% of consolidated revenue, respectively. During the three months ended June 30, 2007 revenue from one foreign customer and one domestic customer represented 76% and 14% of consolidated revenue, respectively.
During the six months ended June 30, 2008, revenue from one foreign customer and one domestic customer represented 55% and 26% of consolidated revenue, respectively. During the six months ended June 30, 2007 revenue from one foreign customer and one domestic customer represented 66% and 19% of consolidated revenue, respectively.
As of June 30, 2008 and December 31, 2007, one foreign customer represented 91% and 94%, respectively, of accounts receivable, net.

 

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion and analysis should be read in conjunction with our consolidated financial statements, including the notes thereto.
Forward-Looking Information
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 Isolagen 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 and other documents, releases and reports released by us, 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;
    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;
    whether our clinical human trials relating to autologous cellular therapy applications for the treatment of dermal defects, gingival recession, 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;
    higher than anticipated dropout rates of subjects in our clinical trials which could adversely affect trial results and make it more difficult to obtain regulatory approval;
    whether the results of our full Phase III pivotal study will support a successful BLA filing;
    adverse results from, or changes in, any pending or threatened legal proceedings;
    our ability to maintain AMEX continued listing of our common stock (see Part II, Item 1a.);
    our ability to provide and deliver any autologous cellular therapies that we may develop on a basis that is competitive with other therapies, drugs and treatments that may be provided by our competitors;
    our ability to decrease our manufacturing costs for our Isolagen 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;
    our ability to improve our historical pricing model;
    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;
    a stable currency rate environment in the world, and specifically the countries we are doing business in or plan to do business in;
    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;

 

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    any adverse claims relating to our intellectual property;
    the adoption of new, or changes in, accounting principles;
    our ability to efficiently integrate our past acquisition and future acquisitions, if any, or any other new lines of business that we may enter in the future;
    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 Isolagen Therapy;
    our ability to effectively and efficiently manage the closure of our UK operation;
    whether past or future amendments to our Informed Consent Forms, based on new knowledge obtained during the execution of our clinical trials or based on changes to the basic design or administration of our clinical trials, give rise to delays in our clinical study timelines; and
    other risks referenced from time to time elsewhere in this report and in our filings with the SEC, including, without limitation, the risks and uncertainties described in Item 1A of our Form 10-K for the year ended December 31, 2007, as well as Part II, Item 1A of this Form 10-Q.
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 undertake no obligation and do not intend to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of any unanticipated events. We cannot assure you that projected results will be achieved.
General
We are an aesthetic and therapeutic development stage 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 Isolagen Process. Our clinical development programs encompass both aesthetic and therapeutic indications. Our most advanced indication utilizing the Isolagen Therapy is for the treatment of nasolabial folds/wrinkles and is currently in Phase III clinical development. We also have an ongoing Phase II/III study for the treatment of acne scars and ongoing Phase II studies related to full face rejuvenation, restrictive burns scars and periodontal disease.
We also develop and market an advanced skin care product line through our Agera Laboratories, Inc. subsidiary, in which we acquired a 57% interest in August 2006.
Going Concern
At June 30, 2008, we had cash and cash equivalents of $11.3 million and working capital of $8.6 million (including cash and cash equivalents). We believe that our existing capital resources are adequate to finance our operations through approximately December 1, 2008, under our normal operating conditions. As such, we estimate that we will require additional cash resources prior to or during the fourth quarter of 2008 based upon our current operating plan and condition.
Through June 30, 2008, we have been primarily engaged in developing our initial product technology. In the course of our development activities, we have sustained losses and expect such losses to continue through at least 2008. We expect to finance our operations primarily through our existing cash and any future financing, including the sale of assets. However, there exists substantial doubt about our ability to continue as a going concern.
As discussed in below under “Clinical Development Programs”, we expect to receive in August, 2008 the results of our pivotal Phase III trials to evaluate the efficacy and safety of Isolagen Therapy for the treatment of nasolabial folds. If those results support the efficacy and safety of the Isolagen Treatment for that purpose, further efforts will be required to obtain final regulatory approval, develop a scalable manufacturing process, and develop the market for the use of the Isolagen Therapy for the treatment of nasolabial folds. In such case, we would be required to obtain additional capital in the future to continue our operations. There is no assurance that we will be able to obtain any such additional capital to finance these efforts, through asset sales, equity or debt financing, or any combination thereof, on satisfactory terms or at all. Additionally, no assurance can be given that any such financing, if obtained, will be adequate to meet our ultimate capital needs and to support our growth. If adequate capital cannot be obtained on a timely basis and on satisfactory terms, our operations would be materially negatively impacted. Further, if we do not obtain additional funding prior to or during the fourth quarter of 2008, we may enter into bankruptcy soon thereafter, and possibly cease operations.

 

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Conversely, if the results of these pivotal Phase III trials do not support the efficacy and safety of Isolagen Therapy for the treatment of nasolabial folds, it may indicate that the Isolagen Process as currently manufactured and administered will not obtain regulatory approval and could not be successfully marketed. In that case, we would be required to research and develop significant changes to the Isolagen Therapy. Such an effort would require substantial additional capital, and there is substantial doubt that we could obtain such capital. In such event, we might be forced to cease operations and enter into bankruptcy.
We filed a shelf registration statement on Form S-3 during June 2007, which was subsequently declared effective by the SEC. The shelf registration allowed us the flexibility to offer and sell, from time to time, up to an original amount of $50 million of common stock, preferred stock, debt securities, warrants or any combination of the foregoing in one or more future public offerings. In August 2007, we sold under this shelf registration statement 6,746,647 shares of common stock to institutional investors, raising proceeds of $13.8 million, net of offering costs. We may offer and sell up to an additional $36.2 million of securities pursuant to this shelf registration.
Our ability to complete additional offerings, including any additional offerings under our shelf registration statement, 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 our company and the offering terms. In addition, our ability to complete an offering may be dependent on the status of our clinical trials, and in particular, the status of our Phase III clinical trial for the treatment of wrinkles as discussed above, which cannot be predicted. There is no assurance that capital in any form would be available to us, and if available, on terms and conditions that are acceptable.
As a result of the conditions discussed above, and in accordance with generally accepted accounting principles in the United States, there exists substantial doubt about our ability to continue as a going concern, and our ability to continue as a going concern is contingent, among other things, upon our ability to secure additional adequate financing or capital prior to or during the fourth quarter of 2008. If we are unable to obtain additional sufficient funds during this time, we will be required to terminate or delay our efforts to obtain regulatory approval of one, more than one, or all of our product candidates, curtail or delay the implementation of manufacturing process improvements and/or delay the expansion of our sales and marketing capabilities. Any of these actions would have an adverse effect on our operations, the realization of our assets and the timely satisfaction of our liabilities. Further, if we do not obtain additional funding prior to or during the fourth quarter of 2008, we may enter into bankruptcy soon thereafter, and possibly cease operations. Our financial statements are presented on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability of the recorded assets or the classification of liabilities that may be necessary should it be determined that we are unable to continue as a going concern.
Recent Management Changes
In January 2008, Mr. Declan Daly assumed the role of our Chief Executive Officer. Our former Chief Executive Officer, Mr. Nicholas L. Teti, Jr., continues to serve as Chairman of the Board of Directors and as a consultant to the company. In March 2008, Mr. Todd J. Greenspan assumed the role of Chief Financial Officer.
Clinical Development Programs
Our product development programs are focused on the aesthetic and therapeutic markets. These programs are supported by a number of clinical trial programs at various stages of development.
Our aesthetics development programs include product candidates to treat targeted areas or wrinkles and to provide full-face rejuvenation that includes the improvement of fine lines, wrinkles, skin texture and appearance. Our therapeutic development programs are designed to treat acne scars, restrictive burn scars and dental papillary recession. All of our product candidates are non-surgical and minimally invasive. Although the discussions below include estimates of when we expect trials to be completed, the prediction of when a clinical trial will be completed is subject to a number of factors and uncertainties.

 

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Aesthetic Development Programs
Wrinkles/Nasolabial Folds — Phase III Trials : In October 2006, we reached an agreement with the U.S. Food and Drug Administration, or FDA, on the design of a Phase III pivotal study protocol for the treatment of nasolabial folds (lines which run from the sides of the nose to the corners of the mouth). The randomized, double-blind protocol was submitted to the FDA under the agency’s Special Protocol Assessment, or SPA. Pursuant to this assessment process, the FDA has agreed that our study design for two identical trials, including subject numbers, clinical endpoints, and statistical analyses, is adequate to provide the necessary data that, depending on the outcome, could form the basis of an efficacy claim for a marketing application. The pivotal Phase III trials will evaluate the efficacy and safety of Isolagen Therapy against placebo in approximately 400 subjects total with approximately 200 subjects enrolled in each trial. We completed enrollment of the study and commenced injection of subjects in early 2007. These injections were completed in January 2008 and we expect the Phase III trial data results in August 2008.
Refer to Part II, Item 1A of this Form 10-Q for a discussion of certain of our risk factors.
Full Face Rejuvenation — Phase II Trial: In March 2007 we commenced an open label (unblinded) trial of approximately 50 subjects. Injections of Isolagen Therapy began to be administered in July 2007. This trial is designed to further evaluate the safety and use of Isolagen Therapy to treat fine lines and wrinkles for the full face. Five investigators across the United States are participating in this trial. The subjects received two series of injections approximately one month apart. In late December 2007, all 45 remaining subjects completed injections. The subjects will be followed for twelve months following each subject’s last injection. Efficacy and primary safety data analyses from the trial are expected to be completed during August 2008.
Therapeutic Development Programs
Acne Scars — Phase II/III Trial: In November 2007, we commenced an acne scar Phase II/III study. This study currently includes approximately 100 subjects. This placebo controlled trial is designed to evaluate the use of our Isolagen Therapy to correct or improve the appearance of acne scars. Each subject will serve as their own control, receiving Isolagen Therapy on one side of their face and placebo on the other. The subjects will receive three injections two weeks apart. The follow-up and evaluation period will be complete four months after each subject’s last injection.
We filed a pre-Investigational New Drug application, or pre-IND, for a Phase III clinical trial program in July 2007 together with our protocol. In September 2007, the IND was accepted by the FDA. We held an investigator meeting in early November 2007 and commenced biopsies shortly thereafter. Injections of subjects began in February 2008 and are currently ongoing.
In connection with this acne scar program, we have developed a validated photo guide for use in the evaluators’ assessment of acne study subjects. We had originally designed the acne scar clinical program as two randomized, double-blind, Phase III, placebo-controlled trials of approximately 120 subjects each. However, our evaluator assessment scale and photo guide have never been utilized in a clinical trial. In November 2007, the FDA recommended that we consider conducting a Phase II study in order to address certain study issues, including additional validation related to our evaluator assessment scale. As such, we modified our clinical plans to initiate a single Phase II/III trial. This Phase II/III study, which is powered to demonstrate efficacy, will allow for a closer assessment of the evaluator assessment scale and photo guide. Upon successful completion of the Phase II/III study, we expect to initiate a subsequent, additional Phase III trial. We believe that the two trials may have the potential to form the basis of a licensure submission to the FDA.
Restrictive Burn Scars - Phase II Trial: In January 2007, we met with the FDA to discuss our clinical program for the use of Isolagen Therapy for restrictive burn scar patients. This Phase II trial will evaluate the use of Isolagen Therapy to improve range of motion, function and flexibility, among other parameters, in existing restrictive burn scars in approximately 20 patients. We are currently in the process of screening and enrolling subjects at three academic burn centers across the United States.

 

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Dental Study - Phase II Trial: In late 2003, we completed a Phase I clinical trial for the treatment of condition relating to periodontal disease, specifically to treat Interdental Papillary Insufficiency. In the second quarter of 2005, we concluded the Phase II dental clinical trial with the use of Isolagen Therapy and subsequently announced that investigator and subject visual analog scale assessments demonstrated that the Isolagen Therapy was statistically superior to placebo at four months after treatment. Although results of the investigator and subject assessment demonstrated that the Isolagen Therapy was statistically superior to placebo, an analysis of objective linear measurements did not yield statistically significant results.
In 2006, we commenced a Phase II open-label dental trial for the treatment of Interdental Papillary Insufficiency. This single site study includes 11 subjects. We are identifying a development strategy for this application as we do not expect to fund an additional trial related to this application.
Agera Skincare Systems
We market and sell a skin care product line through our majority-owned subsidiary, Agera Laboratories, Inc., which we acquired in August 2006. Agera offers a complete line of skincare systems based on a wide array of proprietary formulations, trademarks and nano-peptide technology. These skincare products can be packaged to offer anti-aging, anti-pigmentary and acne treatment systems. Agera markets its products in both the United States and Europe (primarily the United Kingdom).
Closure of the United Kingdom Operation
In the fourth quarter of 2006 our Board of Directors approved the closing of the United Kingdom operation. On March 31, 2007, we completed the closure of the United Kingdom manufacturing facility. With the closure of the United Kingdom operation on March 31, 2007, our European operations (both the United Kingdom and Switzerland) and Australian operations have been presented in the financial statements as discontinued operations for all periods presented. See Note 5 of Notes to Consolidated Financial Statements.
Critical Accounting Policies
The following discussion and analysis of financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in conformity with accounting principles generally accepted in the United States of America. Our significant accounting policies are more fully described in Note 3 of the Notes to the Consolidated Financial Statements. However, certain accounting policies and estimates are particularly important to the understanding of our financial position and results of operations and require the application of significant judgment by our management or can be materially affected by changes from period to period in economic factors or conditions that are outside of the control of management. As a result they are subject to an inherent degree of uncertainty. In applying these policies, our management uses their judgment to determine the appropriate assumptions to be used in the determination of certain estimates. Those estimates are based on our historical operations, our future business plans and projected financial results, the terms of existing contracts, our observance of trends in the industry, information provided by our customers and information available from other outside sources, as appropriate. The following discusses our significant accounting policies and estimates.
Stock-Based Compensation : In December 2004, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 123 (revised 2004), “Share-Based Payment” (“SFAS No. 123 (R)”). SFAS No. 123 (R) replaces SFAS No. 123, “Accounting for Stock-Based Compensation,” supersedes APB Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB No. 25”), and amends SFAS No. 95, “Statement of Cash Flows.” SFAS No. 123 (R) requires entities to recognize compensation expense for all share-based payments to employees and directors, including grants of employee stock options, based on the grant-date fair value of those share-based payments, adjusted for expected forfeitures.
We adopted SFAS No. 123(R) as of January 1, 2006 using the modified prospective application method. Under the modified prospective application method, the fair value measurement requirements of SFAS No. 123(R) is applied to new awards and to awards modified, repurchased, or cancelled after January 1, 2006. Additionally, compensation cost for the portion of awards for which the requisite service has not been rendered that were outstanding as of January 1, 2006 is recognized as the requisite service is rendered on or after January 1, 2006. The compensation cost for that portion of awards is based on the grant-date fair value of those awards as calculated for pro forma disclosures under SFAS No. 123. Changes to the grant-date fair value of equity awards granted before January 1, 2006 are precluded.

 

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The fair value of stock options is determined using the Black-Scholes valuation model, which is consistent with our valuation techniques previously utilized for awards in footnote disclosures required under SFAS No. 123. Prior to the adoption of SFAS No. 123(R), we followed the intrinsic value method in accordance with APB No. 25 to account for our employee and director stock options. Historically, substantially all stock options have been granted with an exercise price equal to the fair market value of the common stock on the date of grant. Accordingly, no compensation expense was recognized from substantially all option grants to employees and directors prior to the adoption of SFAS No. 123(R). However, compensation expense was recognized in connection with the issuance of stock options to non-employee consultants in accordance with EITF 96-18, “Accounting for Equity Instruments That are Issued to Other than Employees for Acquiring, or in Conjunction with Selling Goods and Services.” SFAS No. 123(R) did not change the accounting for stock-based compensation related to non-employees in connection with equity based incentive arrangements.
The adoption of SFAS No. 123(R) requires additional accounting related to the income tax effects and additional disclosure regarding the cash flow effects resulting from share-based payment arrangement. SFAS No. 123(R) resulted in the recognition of compensation expense of $0.2 million and $0.5 million for three months ended June 30, 2008 and 2007, respectively, and $0.4 million and $0.9 million for the six months ended June 30, 2008 and 2007, respectively, related to our employee and director stock options. During the three months ended June 30, 2008, we granted stock options to purchase 0.2 million shares of our common stock. As of June 30, 2008, there was $1.1 million of total unrecognized compensation cost related to non-vested director and employee stock options which vest over time. That cost is expected to be recognized over a weighted-average period of 2.0 years. As of June 30, 2008, there was $0.3 million of total unrecognized compensation cost related to performance-based, non-vested employee stock options. That cost will begin to be recognized when the performance criteria within the respective performance-base option grants become probable of achievement.
During December 2005, the board of directors approved the full vesting of all unvested, outstanding stock options issued to current employees and directors. The board decided to take this action (the “acceleration event”) in anticipation of the adoption of SFAS No. 123 (R). As a result of this acceleration event, stock options to purchase approximately 1.4 million shares of our common stock were vested that would have otherwise vested during 2006 and later periods. At the time of the acceleration event, the unamortized grant date fair value of the affected options was approximately $3.6 million (for SFAS No. 123 and SFAS No. 148 pro forma disclosure purposes), which was charged to pro forma expense in the fourth quarter of 2005. Substantially all of the unvested employee stock options that were subject to the acceleration event had exercise prices above market price of our common stock at the time the board approved the acceleration event. However, in accordance with SFAS 123 (R) if we had not completed this acceleration event in December 2005, the majority of the $3.6 million amount discussed above would have been charged against the future results of operations, beginning in the first quarter of fiscal 2006 and continuing through later periods as the options vested. As discussed above, substantially all of the unvested employee stock options which were accelerated had exercise prices above market price at the time of acceleration. For the purposes of applying APB No. 25 to such stock options in the statement of operations for the year ended December 31, 2005, the acceleration event was treated as the acceleration of the vesting of employee and director options that otherwise would have vested as originally scheduled, and accordingly was not a modification requiring the remeasurement of the intrinsic value of the options, or the application of variable option accounting, under APB No. 25. For stock options that had exercise prices below market price at the time of acceleration and that would not have vested originally, a charge of approximately $15,000 was recorded in the statement of operations for the year ended December 31, 2005.
On January 7, 2008, we and Mr. Nicholas L. Teti, Jr. entered into a consulting and non-competition agreement (the “Consulting Agreement”), pursuant to which Mr. Teti agreed to continue as our non-executive Chairman of the Board and to become a consultant to the company, and Mr. Teti resigned his position as Chief Executive Officer and President. Mr. Teti retained his previously issued stock options which were modified such that Mr. Teti will continue to vest in accordance with the original terms, except as a non-employee. As a result of the modifications to Mr. Teti’s stock options set forth in the Consulting Agreement, we recorded a non-cash compensation charge during the three months ended March 31, 2008 of approximately $1.3 million related to Mr. Teti’s 1,166,665 vested stock options. Further, related to Mr. Teti’s 833,335 unvested stock options at the date of modification, we will record stock option expense over the remaining periods those stock options are earned in accordance with EITF 96-18, “Accounting for Equity Instruments That are Issued to Other than Employees for Acquiring, or in Conjunction with Selling Goods and Services.”

 

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Federal Securities and Derivative Actions and Other Legal Matters: As discussed in Note 7 of Notes to Consolidated Financial Statements, set forth elsewhere in this Report, we are currently defending ourselves against various class and derivative actions. We intend to defend ourselves vigorously against these actions. We cannot currently estimate the amount of loss, if any, that may result from the resolution of these actions, and no provision has been recorded in our consolidated financial statements. Generally, a loss must be both reasonably estimable and probable in order to record a provision for loss. We will expense our legal costs as they are incurred and will record any insurance recoveries on such legal costs in the period the recoveries are received. Although we have not recorded a provision for loss regarding these matters, a loss could occur in a future period.
As discussed in Note 7 of Notes to Consolidated Financial Statements, we have received a written demand by an attorney representing approximately 114 former patients in the United Kingdom that previously received the our treatment each claiming negligent misstatements were made and each claiming, on average, £3,500 (or approximately $7,000), plus unquantified interest and incidental expenses. To date, no formal legal action has been brought by the attorney against us, and no provision has been recorded in the consolidated financial statements related to this matter.
We are involved in various other legal matters that are being defended and handled in the ordinary course of business. Although it is not possible to predict the outcome of these other legal matters, management currently believes that the results will not have a material impact on our financial statements.
Research and Development Expenses: Research and development costs are expensed as incurred and include salaries and benefits, costs paid to third-party contractors to perform research, conduct clinical trials, develop and manufacture drug materials and delivery devices, and a portion of facilities cost. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. Invoicing from third-party contractors for services performed can lag several months. We accrue the costs of services rendered in connection with third-party contractor activities based on our estimate of management fees, site management and monitoring costs and data management costs. Actual clinical trial costs may differ from estimated clinical trial costs and are adjusted for in the period in which they become known.
Impairment of Long-lived Assets: SFAS No.144 (“SFAS 144”), “Accounting for the Impairment of Long-lived Assets and for Long-lived Assets to be Disposed Of” addresses financial accounting and reporting for the impairment or disposal of long-lived assets. SFAS 144 requires that long-lived assets be reviewed for impairment whenever events or changes in circumstances indicate that their carrying amounts may not be recoverable. If the cost basis of a long-lived asset is greater than the projected future undiscounted net cash flows from such asset (excluding interest), an impairment loss is recognized. Impairment losses are calculated as the difference between the cost basis of an asset and its estimated fair value.
At June 30, 2008, we had $2.9 million of property and equipment, net, related to our Isolagen Therapy business segment and $4.4 million of intangible assets related primarily to our Agera business segment. Intangible assets primarily include proprietary formulations and trademarks acquired in connection with the acquisition of Agera, and to a lesser extent certain in-process patents related to our Isolagen Therapy business segment. Proprietary formulations and trademarks are amortized on a straight-line basis over their estimated useful lives, generally for periods ranging from 13 to 18 years. Our process of evaluation of impairment with respect to our property and equipment and intangible assets primarily includes the utilization of internal projections and forecasts, which inherently include significant judgments and assumptions. Such significant judgments and assumptions include those related to the future business performance of Agera, as well as those related to obtaining statistically significant results from our Phase III Wrinkle/Nasolabial Folds trials, obtaining timely FDA approval within certain timeframes and reaching certain levels of commercial revenue. Our judgments and assumptions are subject to change in the future, based on anticipated events or actual events, which may result in a partial impairment or full impairment of our property and equipment and/or intangible assets in future periods. In particular, if the results of the pivotal Phase III trials we expect to receive in August 2008 do not support the efficacy and safety of Isolagen Therapy for the treatment of nasolabial folds, our assumptions concerning the future use and recovery of assets related to the efforts to research and develop the Isolagen Therapy may require revision, and we may be required to recognize partial of full impairment of some of these assets.

 

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Results of Operations
Comparison of the three months ended June 30, 2008 and 2007
REVENUE. Revenue decreased less than $0.1 million to $0.3 million for the three months ended June 30, 2008, as compared to $0.3 million for the three months ended June 30, 2007. 60% and 76% of Agera’s revenue were to one foreign customer during the three months ended June 30, 2008 and June 30, 2007, respectively. As such, total revenue is subject to fluctuation depending primarily on the orders received and orders fulfilled with respect to this large customer. Further, we believe that the decline in general economic conditions during 2008 have also contributed to the decline in revenue associated with our Agera line of skincare products.
COST OF SALES. Costs of sales were $0.1 million for the three months ended June 30, 2008, as compared to $0.2 million for the three months ended June 30, 2007. Our cost of sales relates to the operation of Agera. As a percentage of revenue, Agera cost of sales were approximately 54% for the three months ended June 30, 2008 and 45% for the three months ended June 30, 2007. Cost of sales as a percentage of revenue have increased primarily due to changes in our product mix, as well as decreased overall volumes (which can result in higher per unit costs for components associated with our Agera product line).
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses decreased approximately $3.5 million, or 61%, to $2.2 million for the three months ended June 30, 2008, as compared to $5.7 million for the three months ended June 30, 2007. The decrease in selling, general and administrative expense is primarily due to the following:
a) Employee compensation, bonuses and payroll taxes decreased by approximately $2.1 million to $0.7 million for the three months ended June 30, 2008, as compared to $2.8 million for the three months ended June 30, 2007, due primarily to (1) the departure of senior-level employees, including our former CEO and former President (and savings related to salaries, severance and bonus earned during the three months ended June 30, 2007) and (2) lower stock option compensation expense as a result of the departure of these employees. Also, the fair value of the stock options granted during the current period has been lower as compared to the similar prior year comparable period primarily as a result of the lower average price of our common stock.
b) Marketing expense decreased by approximately $0.4 million to less than $0.1 million for the three months ended June 30, 2008, as compared to $0.4 million for the three months ended June 30, 2007. Agera marketing expenses have decreased during the three months ended June 30, 2008 due primarily to a decrease in marketing and promotional efforts related to selling our Agera line of advanced skin care systems undertaken to offset decreased revenue.
c) Travel expense decreased by approximately $0.2 million to less than $0.1 million for the three months ended June 30, 2008, as compared to $0.3 million for the three months ended June 30, 2007 due to the decrease in the number of our employees, primarily at the executive management level.
d) Other general and administrative operating costs decreased by approximately $0.6 million to $0.9 million for the three months ended June 30, 2008, as compared to $1.5 million for the three months ended June 30, 2007 due primarily to reduced business development expenses and cost savings initiatives within the company.

 

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e) Legal expenses decreased by $0.2 million to $0.4 million for the three months ended June 30, 2008, as compared to the three months ended June 30, 2007. For the three months ended June 30, 2008, we received a $0.4 million reimbursement from our insurance carrier as reimbursement for defense costs related to our class action and derivative matters. If we had not received this $0.4 million reimbursement, our legal expenses would have been $0.8 million for the three months ended June 30, 2008. For the three months ended June 30, 2007, we received a $0.6 million reimbursement from our insurance carrier as reimbursement for defense costs related to our class action and derivative matters. If we had not received this $0.6 million reimbursement, our legal expenses would have been approximately $1.0 million for the three months ended June 30, 2007. Our legal expenses fluctuate primarily as a result of the amount and timing of defense costs related to our class action and derivative action matters, as well as a result of the amount and timing of defense cost reimbursements from our insurance carrier. We also incurred $0.1 million in legal costs, during the three months ended June 30, 2008, related to investigating and responding to claims related to the United Kingdom (refer Note 7 — Commitments and Contingencies for a discussion of our various legal matters).
RESEARCH AND DEVELOPMENT. Research and development expenses decreased by approximately $0.1 million for the three months ended June 30, 2008 to $3.3 million, as compared to $3.4 million for the three months ended June 30, 2007. The decrease of $0.1 million is primarily due to reduced salaries with the departure of two senior-level personnel.
Research and development costs are composed primarily of costs related to our efforts to gain FDA approval for our Isolagen Therapy for specific dermal applications in the United States, as well as costs related to other potential indications for our Isolagen Therapy. 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 our FDA clinical trials (see Clinical Development Programs discussion above) and certain consulting costs. The total inception to date cost of research and development as of June 30, 2008 was $50.1 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 dermal 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, as occurred during 2005 with respect to our first pivotal Phase III dermal trial, 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 at this time. We have other research projects currently underway. However, research and development costs related to these projects were not material during the three months ended June 30, 2008 and 2007.
LOSS FROM DISCONTINUED OPERATIONS. As discussed above under “—Closure of the United Kingdom Operation,” during the three months ended December 31, 2006, the Board of Directors approved the closure of our United Kingdom operation. The United Kingdom operation was closed in March 2007.
The loss from discontinued operations decreased by approximately $0.1 million for the three months ended June 30, 2008 to $0.2 million, as compared to $0.3 million for the three months ended June 30, 2007. The $0.3 million loss from discontinued operations during the three months ended June 30, 2007 primarily consisted of facility expense, legal expense and public relations costs. The $0.2 million loss from discontinued operations for the three months ended June 30, 2008 is primarily due to administrative expenses related to our dormant Swiss legal entity and facility expenses related to our United Kingdom legal entity.
INTEREST INCOME. Interest income decreased approximately $0.2 million to less than $0.1 million for the three months ended June 30, 2008, as compared to $0.2 million for the three months ended June 30, 2007. The decrease in interest income of $0.2 million resulted principally from a decrease in the amount of cash, cash equivalents and restricted cash balances, as compared to the prior year comparable period, as a result of the use of those cash resources to finance our normal operating activities primarily related to our efforts to gain FDA approval for our Isolagen Therapy, and due to declining interest rates.
INTEREST EXPENSE. Interest expense remained constant at $1.0 million for the three months ended June 30, 2008, as compared to the three months ended June 30, 2007. Our interest expense is related to our $90.0 million, 3.5% convertible subordinated notes, as well as the related amortization of deferred debt issuance costs of $0.2 million for the three months ended June 30, 2008 and 2007, respectively.

 

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NET LOSS. Net loss decreased approximately $3.3 million to $6.4 million for the three months ended June 30, 2008, as compared to a net loss of $9.7 million for the three months ended June 30, 2007. This decrease in net loss primarily represents the effects of the decreases in our selling, general and administrative expenses and research and development expenses, as well as our decrease in loss from discontinued operation, as discussed above.
Comparison of the six months ended June 30, 2008 and 2007
REVENUES. Revenue decreased $0.2 million to $0.5 million for the six months ended June 30, 2008, as compared to $0.7 million for the six months ended June 30, 2007. Of Agera’s revenue, 55% and 66% were to one foreign customer during the six months ended June 30, 2008 and June 30, 2007, respectively. As such, total revenue is subject to fluctuation depending primarily on the orders received and orders fulfilled with respect to this large customer. Further, we believe the decline in general economic conditions during 2008 have also contributed to the decline in revenue associated with our Agera line of skincare products.
COST OF SALES. Costs of sales remained constant at $0.3 million for the six months ended June 30, 2008 and June 30, 2007. Our cost of sales relates to the operation of Agera. As a percentage of revenue, Agera cost of sales were approximately 65% for the six months ended June 30, 2008 and 48% for the six months ended June 30, 2007. The increase in costs of sales as a percentage of revenue is due to a reserve of less than $0.1 million for excessive and/or obsolete inventory recorded during the three months ended March 31, 2008. Had no reserve been recorded during the three months ended March 31, 2008, Agera cost of sales would have been approximately 53% for the six months ended June 30, 2008. Also cost of sales as a percentage of revenue have increased due to changes in the product mix, as well as decreased overall volumes (which can result in higher per unit costs for components associated with our Agera product line).
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses decreased approximately $5.9 million, or 49%, to $6.2 million for the six months ended June 30, 2008, as compared to $12.0 million for the six months ended June 30, 2007. The decrease in selling, general and administrative expense is primarily due to the following:
a) Employee compensation, bonuses and payroll taxes decreased by approximately $4.4 million to $2.8 million for the six months ended June 30, 2008, as compared to $7.2 million for the six months ended June 30, 2007, due primarily to (1) the departure of senior-level employees, including our former CEO and former President (and savings related to salaries, severance and bonus) and (2) lower stock option compensation expense as a result of the departure of these employees. Also, the fair value of the stock options granted during the current period has been lower as compared to the similar prior year comparable period primarily as a result of the lower average price of our common stock.
b) Marketing expense decreased by approximately $0.6 million to less than $0.1 million for the six months ended June 30, 2008, as compared to $0.6 million during the six months ended June 30, 2007 due primarily to a decrease in marketing and promotional efforts related to selling our Agera line of advanced skin care systems undertaken to offset decreased revenue.
c) Travel expense decreased by approximately $0.3 million to $0.2 million for the six months ended June 30, 2008, as compared to $0.5 million for the six months ended June 30, 2007 due to the decrease in the number of our employees, primarily at the executive management level, and decrease in business development activities.
d) Other general and administrative operating costs decreased by approximately $0.7 million to $2.4 million for the six months ended June 30, 2008, as compared to $3.1 million for the six months ended June 30, 2007 due primarily to a decreased in costs related to corporate development and due diligence activities.

 

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e) Legal expenses increased by $0.1 million, to $0.8 million for the six months ended June 30, 2008, as compared to $0.7 million for the six months ended June 30, 2007. For the six months ended June 30, 2008, we received a $0.5 million reimbursement from our insurance carrier as reimbursement for defense costs related to our class action and derivative matters. If we had not received this $0.5 million reimbursement, our legal expenses would have been $1.3 million for the six months ended June 30, 2008. For the six months ended June 30, 2007, we received a $1.4 million reimbursement from our insurance carrier as reimbursement for defense costs related to our class action and derivative matters. If we had not received this $1.4 million reimbursement, our legal expenses would have been approximately $2.1 million for the six months ended June 30, 2007. Our legal expenses fluctuate primarily as a result of the amount and timing of defense costs related to our class action and derivative action matters, as well as a result of the amount and timing of defense cost reimbursements from our insurance carrier. We also incurred $0.2 million in legal costs, during the six months ended June 30, 2008, related to investigating and responding to claims related to the United Kingdom (refer Note 7 — Commitments and Contingencies for a discussion of our various legal matters).
RESEARCH AND DEVELOPMENT. Research and development expenses decreased by approximately $0.4 million for the six months ended June 30, 2008 to $6.1 million, as compared to $6.5 million for the six months ended June 30, 2007. The decrease of $0.4 million is primarily due to reduced salaries with the departure of two senior-level personnel.
Research and development costs are composed primarily of costs related to our efforts to gain FDA approval for our Isolagen Therapy for specific dermal applications in the United States, as well as costs related to other potential indications for our Isolagen Therapy. 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 our FDA clinical trials (see Clinical Development Programs discussion above) and certain consulting costs. The total inception to date cost of research and development as of June 30, 2008 was $50.1 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 dermal 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, as occurred during 2005 with respect to our first pivotal Phase III dermal trial, 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 at this time. We have other research projects currently underway. However, research and development costs related to these projects were not material during the six months ended June 30, 2008 and 2007.
LOSS FROM DISCONTINUED OPERATIONS. As discussed above under “—Closure of the United Kingdom Operation,” during the three months ended December 31, 2006, the Board of Directors approved the closure of our United Kingdom operation. The United Kingdom operation was closed in March 2007.
The loss from discontinued operations increased by approximately $3.1 million for the six months ended June 30, 2008 to $4.5 million, as compared to $1.4 million for the six months ended June 30, 2007. The $4.5 million loss from discontinued operations for the six months ended June 30, 2008 primarily related to the sale of our Swiss campus in March 2008. In connection with this sale, we recorded a loss on sale of $6.3 million, offset by a foreign currency exchange gain of $2.1 million upon the substantial liquidation of the Swiss subsidiary. The foreign exchange gain recorded during the three months ended March 31, 2008 results from removing from the accumulated foreign currency translation adjustment account in stockholders’ equity a credit balance which related to the translation into U.S. dollars of our Swiss franc assets and liabilities. The credit balance which had accumulated, and the resulting gain recorded upon the substantial liquidation of our Swiss franc assets, reflected the increase in the value of the Swiss franc relative to the U.S. dollar over the period that we had operated in Switzerland. Refer to Notes 3 and 5 of Notes to the Consolidated Financial Statements for further discussion regarding the sale of the Swiss campus and results from discontinued operations. Administrative and facility costs related to the United Kingdom and Switzerland comprised the remaining costs of approximately $0.3 million, net.

 

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The $1.4 million loss from discontinued operations during the six months ended June 30, 2007 consisted of $1.1 million of losses incurred during the first quarter 2007, which was the United Kingdom’s last quarter of full operations, and $0.3 million of second quarter 2007 losses, as discussed under “Comparison of the three months ended June 30, 2008 and 2007” above. The $1.1 million loss from discontinued operations during the three months ended March 31, 2007 primarily consisted of the following:
a) Salaries, severance expense and payroll taxes were approximately $0.3 million for the three months ended March 31, 2007.
b) Other general and administrative operating costs were approximately $0.5 million primarily related to lease expense and operating costs incurred during the three months ended March 31, 2007.
c) Gross loss was $0.3 million during the three months ended March 31, 2007, primarily due to low production volumes during the shutdown period and due to the write-off of unrealizable inventory used in the manufacturing process.
INTEREST INCOME. Interest income decreased approximately $0.4 million to $0.1 million for the six months ended June 30, 2008, as compared to $0.5 million for the six months ended June 30, 2007. The decrease in interest income of $0.4 million resulted principally from a decrease in the amount of cash, cash equivalents and restricted cash, as a result of the use of those cash resources to finance our normal operating activities primarily related to our efforts to gain FDA approval for our Isolagen Therapy, and due to declining interest rates.
INTEREST EXPENSE. Interest expense remained constant at $2.0 million for the six months ended June 30, 2008, as compared to the six months ended June 30, 2007. Our interest expense is related to our $90.0 million, 3.5% convertible subordinated notes, as well as the related amortization of deferred debt issuance costs of $0.4 million for the six months ended June 30, 2008 and 2007, respectively.
NET LOSS. Net loss decreased $2.3 million to $18.4 million for the six months ended June 30, 2008, as compared to a net loss of $20.7 million for the six months ended June 30, 2007. This decrease in net loss primarily represents the effects of the decreases in our selling, general and administrative expenses and research and development expenses, offset by our increase in loss from discontinued operation, as discussed above.
LIQUIDITY AND CAPITAL RESOURCES
Net cash provided by (used in) operating, investing and financing activities for the six months ended June 30, 2008 and 2007, respectively, were as follows:
                 
    Six Months Ended June 30,  
    2008     2007  
    (in millions)  
Cash flows from operating activities
  $ (11.7 )   $ (18.0 )
Cash flows from investing activities
    6.4       (0.1 )
Cash flows from financing activities
           
Operating Activities
Cash used in operating activities during the six months ended June 30, 2008 amounted to $11.7 million, as compared to $18.0 million of cash used in operating activities during the six months ended June 30, 2007. The decrease in the cash used in operations of $6.3 million is primarily due to our decrease in net loss, adjusted for noncash items, of $6.2 million. Our net loss, adjusted for noncash items, decreased from $17.6 million during the six months ended June 30, 2007 to $11.4 million during the six months ended June 30, 2008 (refer to Results of Operations-Comparison of the six months ended June 30, 2008 and 2007 discussion above and Cash Flows Related to Discontinued Operations below). This decrease in net loss, adjusted for noncash items, was offset by changes in net operating assets and liabilities, which positively impacted cash flows by $0.1 million. During the six months ended June 30, 2008, our changes in net operating assets and liabilities resulted in a cash outflow of $0.3 million, as compared to a cash outflow of $0.4 million during the six months ended June 30, 2007. For the six months ended June 30, 2008, we financed our operating cash flow needs from our cash on hand at the beginning of the period, which were primarily the result of previously completed debt and equity offerings, as well as from the proceeds of the sale of our Swiss campus in March 2008, discussed further below.

 

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Investing Activities
Cash provided by investing activities during the six months ended June 30, 2008 amounted to approximately $6.4 million as compared to cash used in investing activities of less than $0.1 million during the six months ended June 30, 2007. Investing activities during the six months ended June 30, 2008 related primarily to the sale of our Swiss campus in March 2008 for approximately $6.4 million, net of selling costs.
Cash Flows Related to Discontinued Operations
Cash flows related to discontinued operations, which are included in the table of cash flows above, were as follows:
                 
    Six Months Ended June 30,  
    2008     2007  
    (in millions)  
Cash flows from operating activities
  $ (0.2 )   $ (2.2 )
Cash flows from investing activities
    6.4        
Cash flows from financing activities
           
The cash provided by investing activities during the six months ended June 30, 2008 of $6.4 million is discussed above under “Investing Activities.”
Cash flows used in discontinued operations during the six months ended June 30, 2007 was $2.2 million. Our United Kingdom operation was active during the three months ended March 31, 2007, and was shutdown on March 31, 2007. The net loss from our United Kingdom operation during the three months ended March 31, 2007 was $1.1 million. In addition, accrued expenses and deferred revenue decreased by $1.2 million during this shutdown period (cash outflows), primarily related to the payment of severance and refunds to customers. The United Kingdom net loss and the large decrease in United Kingdom accrued expenses and United Kingdom deferred revenue is what primarily generated $2.2 million of cash outflow from discontinued operations for the six months ended June 30, 2007.
Working Capital
General
As of June 30, 2008, we had cash, cash equivalents of $11.3 million and working capital of $8.6 million (including our cash and cash equivalents). We believe our existing capital resources are adequate to finance our operations through approximately December 1, 2008, under our normal operating plan; however, our long-term viability is dependent upon the approval of our products, the successful operation of our business, our ability to improve our manufacturing process, and the ability to raise additional debt and/or equity to meet our business objectives. We estimate that we will require additional cash resources prior to or during the fourth quarter of 2008 based upon our current operating plan and condition. See “—Going Concern” above.
We filed a shelf registration statement on Form S-3 during June 2007, which was declared effective by the Securities and Exchange Commission (“SEC”). In August 2007, we raised $13.8 million, net of offering costs, under this shelf registration via the sale of 6.8 million shares of our common stock to institutional investors. The shelf registration allowed us the flexibility to offer and sell, from time to time, up to an original amount of $50 million of common stock, preferred stock, debt securities, warrants or any combination of the foregoing in one or more future public offerings. As of June 30, 2008, we can offer and sell up to an additional $36.2 million of securities pursuant to this shelf registration.
Our ability to complete an offering, including any additional offerings under our shelf registration statement, 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 Isolagen and the offering terms. Our ability to commence an offering may be dependent on our ability to complete the registration process, which is subject to the SEC’s regulatory calendar, as well as our ability to timely respond to any SEC comments. There is no assurance that capital in any form would be available to us, and if available, on terms and conditions that are acceptable.

 

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As a result of the conditions discussed above, and in accordance with generally accepted accounting principles in the United States, there exists substantial doubt about our ability to continue as a going concern, and our ability to continue as a going concern is contingent upon our ability to secure additional adequate financing or capital prior to or during the fourth quarter of 2008. If we are unable to obtain additional sufficient funds prior to this time, we will be required to terminate or delay regulatory approval of one, more than one, or all of our product candidates, curtail or delay the implementation of manufacturing process improvements or delay the expansion of our sales and marketing capabilities. Any of these actions would have an adverse affect on our operations, the realization of our assets and the timely satisfaction of our liabilities. Our financial statements are presented on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability of the recorded assets or the classification of liabilities that may be necessary should it be determined that we are unable to continue as a going concern.
$90.0 million, 3.5% Convertible Subordinated Notes
In November 2004, we issued $90.0 million in principal amount of 3.5% convertible subordinated notes due November 1, 2024.
The notes are our general, unsecured obligations. The notes are subordinated in right of payment, which means that they will rank in right of payment behind other indebtedness of ours. In addition, the notes are effectively subordinated to all existing and future liabilities of our subsidiaries. We will be required to repay the full principal amount of the notes on November 1, 2024 unless they are previously converted, redeemed or repurchased.
The notes bear interest at an annual rate of 3.5% from the date of issuance of the notes. We pay interest twice a year, on each May 1 and November 1, until the principal is paid or made available for payment or the notes have been converted. Interest is calculated on the basis of a 360-day year consisting of twelve 30-day months.
The note holders may convert the notes into shares of our common stock at any time before the close of business on November 1, 2024, unless the notes have been previously redeemed or repurchased as discussed below. The initial conversion rate (which is subject to adjustment) for the notes is 109.2001 shares of common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of approximately $9.16 per share. Holders of notes called for redemption or submitted for repurchase will be entitled to convert the notes up to and including the business day immediately preceding the date fixed for redemption or repurchase.
At any time on or after November 1, 2009, we may redeem some or all of the notes at a redemption price equal to 100% of the principal amount of such notes plus accrued and unpaid interest (including additional interest, if any) to, but excluding, the redemption date.
The note holders will have the right to require us to repurchase their notes on November 1 of 2009, 2014 and 2019. In addition, if we experience a fundamental change (which generally will be deemed to occur upon the occurrence of a change in control or a termination of trading of our common stock), note holders will have the right to require us to repurchase their notes. In the event of certain fundamental changes that occur on or prior to November 1, 2009, we will also pay a make-whole premium to holders that require us to purchase their notes in connection with such fundamental change.
Factors Affecting Our Capital Resources
An adverse result related to our class action matters and/or derivative action matters, or related to our United Kingdom claims (see Note 7 in Notes to Consolidated Financial Statements), could materially, adversely affect our existing working capital, thereby materially impacting the financial position of the Company.
Inflation did not have a significant impact on the Company’s results during the three months ended June 30, 2008.

 

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Off-Balance Sheet Transactions
We do not engage in material off-balance sheet transactions, except for our long-term Exton, Pennsylvania facility operating lease (refer to our previously filed Form 10-K for the year ending December 31, 2007).
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. We are exposed to market risk in the form of foreign exchange rate risk and interest rate risk.
Foreign Exchange Rate Risk
As the result of the sale of our Swiss campus in March 2008, we now have less than $0.2 million of foreign assets and $0.5 million of foreign liabilities on our consolidated balance sheet as of June 30, 2008. As such, we do not believe that we have significant foreign exchange rate risk at June 30, 2008.
Interest Rate Risk
Our 3.5%, $90.0 million convertible subordinated notes, pay interest at a fixed rate and, accordingly, we are not exposed to interest rate risk as a result of this debt. However, the fair value of our $90.0 million convertible subordinated notes does vary based upon, among other factors, the price of our common stock and current interest rates on similar instruments.
We do not enter into derivatives or other financial instruments for trading or speculative purposes.
ITEM 4. CONTROLS AND PROCEDURES
  (a)   Disclosure Controls and Procedures. Our management, with the participation of our Chief Executive Officer, and our Chief Financial Officer (the “Certifying Officers”), has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under 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, the Certifying Officers have concluded that our disclosure controls and procedures were effective for the purpose of ensuring that material information required to be in this quarterly report is made known to them by others on a timely basis and that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
  (b)   Changes in Internal Controls. There has been no change in our internal control over financial reporting that occurred during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Refer to Note 7 of Notes to the Consolidated Financial Statements, within Part I of this Form 10-Q, for a discussion of legal proceedings.
ITEM 1A. RISK FACTORS
In addition to the Risk Factors disclosed in our December 31, 2007 Form 10-K, investors should consider the following risks and uncertainties, or updates to such risks and uncertainties, prior to making an investment decision with respect to our securities.

 

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Higher than anticipated dropout rates of subjects in our clinical trials could adversely affect trial results and make it more difficult to obtain regulatory approval.
Enrollment of 421 patients in our Phase III nasolabial/wrinkle trials was completed in February 2007. Our Phase III clinical trials include three separate treatment sessions for each subject followed by a 26 week efficacy observation period. Patient dropouts are expected and can occur for a variety of reasons. A subject who drops out of the trial prior to the 26 week post-treatment observation would, under the current protocol, be considered a “failure to respond” in the results of the clinical trial. As fewer patients complete a trial, a higher positive response rate to the therapy must be obtained for the group of remaining treated subjects in order to demonstrate statistically significant benefit compared to placebo. Our Phase III nasolabial/wrinkle trial consists of two studies, 006 and 005. Our 006 study enrolled 218 subjects and 191 completed the study. Our 005 study enrolled 203 subjects and 168 completed the study.
Higher than anticipated dropout rates may result in additional time, expense and uncertainty which may also affect our ability to obtain FDA clearance of our product and which could ultimately adversely affect our profitability and financial position.
Protocol deviations may release the FDA from its binding acceptance of our Special Protocol Assessment (“SPA”) study design, which may result in the delay, or non-approval, by the FDA of the Isolagen Therapy.
In connection with preparations for FDA Investigator Inspections related to our nasolabial fold/wrinkle Phase III studies, we identified protocol deviations related to the timing of visits and other types of deviations. The possibility exists that our special protocol assessment could no longer be binding on the FDA if the FDA considers these deviations, individually or in aggregate, to be significant. Further, future investigator audits may identify deviations unknown at this time. Accordingly, the possibility exists that our Phase III studies may yield statistically significant results, yet may not be acceptable to the FDA under the SPA.
We are not in compliance with the American Stock Exchange’s continued listing standards and, as a result, our common stock may be delisted from the American Stock Exchange.
On March 12, 2008, we received a notice from the American Stock Exchange (AMEX) advising us that we did not meet certain of the continued listing standards as set forth in Part 10 of the AMEX Company Guide. AMEX notified us that we were not in compliance with Sections 1003 (a)(i)-(iii) of the AMEX Company Guide. Specifically, the AMEX staff noted that our stockholder’s equity was less than $2,000,000 and losses from continuing operations and net losses were incurred in two out of our three most recent fiscal years; that our stockholder’s equity was less than $4,000,000 and losses from continuing operations and/or net losses were incurred in three out of our four most recent fiscal years; and that our stockholder’s equity was less than $6,000,000 and losses from continuing operations and/or net losses were incurred in our five most recent fiscal years. However, AMEX will not normally consider suspending dealings in the securities of a company which is below any of the above standards if the company (a) has a market capitalization of at least $50,000,000, and (b) has at least 1,100,000 shares publicly held, with a market value of publicly held shares of at least $15,000,000 and 400 round lot shareholders. We do not currently meet these market capitalization amounts.
We submitted a plan to AMEX on April 14, 2008 that outlined our strategy to bring ourself back into compliance by September 14, 2009. The plan was not accepted by AMEX, and as such, we are subject to delisting procedures as set forth in Section 1010 and Part 12 of the Amex Company Guide. Under AMEX rules, we have the right to appeal any determination by AMEX to initiate delisting proceedings. We have appealed the determination and we will present our appeal to AMEX at a hearing scheduled for August 19, 2008. There can be no assurance that our request for continued listing will be granted after such hearing.

 

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ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On June 12, 2008, we held our 2008 Annual Meeting of Stockholders at our offices in Exton, Pennsylvania. Mr. Declan Daly and Mr. Henry Toh were elected as directors by our stockholders at the meeting to serve until the 2011 annual meeting of stockholders or until their respective successors have been duly elected and qualified. Our stockholders ratified the appointment of BDO Seidman, LLP as our auditors for the year ending December 31, 2008.
The results of the vote were as follows:
1. To elect two directors to hold office until our 2011 annual meeting of stockholders, or until his successor is duly elected and qualified.
     
Shares voted FOR/WITHHELD Mr. Declan Daly:
  28,606,776 / 3,049,394
 
Shares voted FOR/WITHHELD: Mr. Henry Toh
  23,276,077 / 8,380,093
2. To ratify the appointment of BDO Seidman, LLP as our auditors for the year ending December 31, 2008.
     
Shares voted FOR/AGAINST/ABSTAINING:
  31,405,826 / 201,369 / 48,974
In addition, to Messrs. Daly and Toh, the following persons continued as directors after the meeting: Nicholas L. Teti, Jr., Steven Morrell, Marshall Webb, Terry Vandewarker and Kenneth Selzer.
ITEM 6. EXHIBITS
         
EXHIBIT NO.   IDENTIFICATION OF EXHIBIT
       
 
  31.1    
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
       
 
  31.2    
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
       
 
  32.1    
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
       
 
  32.2    
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
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.
         
  ISOLAGEN, INC.
 
 
Date: July 29, 2008  By:   /s/ Todd J. Greenspan  
    Todd J. Greenspan, Chief Financial Officer   
    (Principal Financial Officer)   
 

 

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