PART I - FINANCIAL INFORMATION
Isolagen, Inc.
(A Development Stage Company)
Consolidated Balance Sheets
(Unaudited)
|
|
September 30,
|
|
December 31,
|
|
|
|
2007
|
|
2006
|
|
Assets
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
23,351,762
|
|
$
|
31,783,545
|
|
Restricted cash
|
|
720,045
|
|
1,483,197
|
|
Accounts
receivable, net of allowance for doubtful accounts of $18,041 and $0,
respectively
|
|
226,252
|
|
81,502
|
|
Inventory
|
|
700,798
|
|
181,865
|
|
Other
receivables
|
|
1,709
|
|
357
|
|
Prepaid expenses
|
|
347,840
|
|
860,244
|
|
Current assets
of discontinued operations
|
|
30,699
|
|
739,009
|
|
Total current
assets
|
|
25,379,105
|
|
35,129,719
|
|
Property and
equipment, net of accumulated depreciation and amortization of $2,636,217 and
$1,816,125, respectively
|
|
3,555,444
|
|
4,331,605
|
|
Intangible
assets, net of amortization of $626,926 and $381,795, respectively
|
|
4,691,374
|
|
4,936,505
|
|
Other assets,
net of amortization of $2,185,279 and $1,623,352, respectively
|
|
1,634,364
|
|
2,204,685
|
|
Assets of
discontinued operations held for sale
|
|
11,003,373
|
|
10,503,234
|
|
Other long-term
assets of discontinued operations
|
|
95,218
|
|
181,127
|
|
Total assets
|
|
$
|
46,358,878
|
|
$
|
57,286,875
|
|
|
|
|
|
|
|
Liabilities,
Minority Interests and Shareholders Deficit
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
|
758,569
|
|
$
|
886,598
|
|
Accrued expenses
|
|
4,529,045
|
|
2,891,462
|
|
Current
liabilities of discontinued operations
|
|
210,300
|
|
1,863,857
|
|
Total current
liabilities
|
|
5,497,914
|
|
5,641,917
|
|
Long term debt
|
|
90,000,000
|
|
90,000,000
|
|
Other long term
liabilities of continuing operations
|
|
1,170,345
|
|
999,940
|
|
Long term
liabilities of discontinued operations
|
|
171,655
|
|
164,227
|
|
Total
liabilities
|
|
96,839,914
|
|
96,806,084
|
|
Commitments and
contingencies (see Note 7)
|
|
|
|
|
|
Minority
interests
|
|
1,821,527
|
|
2,104,373
|
|
|
|
|
|
|
|
Shareholders
deficit:
|
|
|
|
|
|
Preferred stock,
$.001 par value; 5,000,000 shares authorized, which includes series C junior
participating preferred stock, 10,000 shares authorized
|
|
|
|
|
|
Common stock,
$.001 par value; 100,000,000 shares authorized
|
|
41,640
|
|
34,363
|
|
Additional
paid-in capital
|
|
128,829,716
|
|
111,516,561
|
|
Treasury stock,
at cost, 4,000,000 shares
|
|
(25,974,000
|
)
|
(25,974,000
|
)
|
Accumulated other
comprehensive income (loss)
|
|
353,850
|
|
(127,462
|
)
|
Accumulated
deficit during development stage
|
|
(155,553,769
|
)
|
(127,073,044
|
)
|
Total
shareholders deficit
|
|
(52,302,563
|
)
|
(41,623,582
|
)
|
Total
liabilities, minority interests and shareholders deficit
|
|
$
|
46,358,878
|
|
$
|
57,286,875
|
|
The accompanying notes are an integral part of these consolidated
financial statements.
1
Isolagen, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
(Unaudited)
|
|
Three Months Ended
September 30,
|
|
|
|
2007
|
|
2006
|
|
Revenue
|
|
|
|
|
|
Product sales
|
|
$
|
331,115
|
|
$
|
141,428
|
|
License fees
|
|
|
|
|
|
Total revenue
|
|
331,115
|
|
141,428
|
|
Cost of sales
|
|
158,096
|
|
72,444
|
|
Gross profit
|
|
173,019
|
|
68,984
|
|
|
|
|
|
|
|
Selling, general
and administrative expenses
|
|
4,010,119
|
|
2,703,843
|
|
Research and
development
|
|
3,093,187
|
|
1,843,974
|
|
Operating loss
|
|
(6,930,287
|
)
|
(4,478,833
|
)
|
Other income
(expense)
|
|
|
|
|
|
Interest income
|
|
193,370
|
|
551,340
|
|
Interest expense
|
|
(974,810
|
)
|
(974,810
|
)
|
Minority
interest
|
|
41,365
|
|
27,839
|
|
Loss from
continuing operations
|
|
(7,670,362
|
)
|
(4,874,464
|
)
|
Loss from
discontinued operations, net of tax
|
|
(128,111
|
)
|
(1,797,416
|
)
|
Net loss
|
|
$
|
(7,798,473
|
)
|
$
|
(6,671,880
|
)
|
|
|
|
|
|
|
Per share
information:
|
|
|
|
|
|
Loss from
continuing operationsbasic and diluted
|
|
$
|
(0.23
|
)
|
$
|
(0.16
|
)
|
Loss from
discontinued operationsbasic and diluted
|
|
|
|
(0.06
|
)
|
Net loss per
common sharebasic and diluted
|
|
$
|
(0.23
|
)
|
$
|
(0.22
|
)
|
Weighted average
number of basic and diluted common shares outstanding
|
|
33,893,072
|
|
30,342,866
|
|
The accompanying notes are an integral part of these consolidated
financial statements.
2
Isolagen, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
(Unaudited)
|
|
Nine Months Ended
September 30,
|
|
Cumulative
Period from
December 28,
1995 (date of
inception) to
September 30,
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
Revenue
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
991,452
|
|
$
|
141,428
|
|
$
|
2,765,955
|
|
License fees
|
|
|
|
|
|
260,000
|
|
Total revenue
|
|
991,452
|
|
141,428
|
|
3,025,955
|
|
Cost of sales
|
|
474,556
|
|
72,444
|
|
1,071,212
|
|
Gross profit
|
|
516,896
|
|
68,984
|
|
1,954,743
|
|
|
|
|
|
|
|
|
|
Selling, general
and administrative expenses
|
|
16,053,949
|
|
8,760,278
|
|
63,469,171
|
|
Research and
development
|
|
9,554,290
|
|
6,442,360
|
|
40,244,986
|
|
Operating loss
|
|
(25,091,343
|
)
|
(15,133,654
|
)
|
(101,759,414
|
)
|
Other income
(expense)
|
|
|
|
|
|
|
|
Interest income
|
|
727,052
|
|
1,812,573
|
|
6,633,567
|
|
Other income
|
|
65,138
|
|
|
|
237,581
|
|
Interest expense
|
|
(2,924,429
|
)
|
(2,924,430
|
)
|
(11,684,031
|
)
|
Minority
interest
|
|
282,846
|
|
27,839
|
|
360,978
|
|
Loss from
continuing operations before income taxes
|
|
(26,940,736
|
)
|
(16,217,672
|
)
|
(106,211,319
|
)
|
Income tax
benefit
|
|
|
|
|
|
190,754
|
|
Loss from continuing
operations
|
|
(26,940,736
|
)
|
(16,217,672
|
)
|
(106,020,565
|
)
|
Loss from
discontinued operations, net of tax
|
|
(1,539,989
|
)
|
(8,503,373
|
)
|
(36,519,519
|
)
|
Net loss
|
|
(28,480,725
|
)
|
(24,721,045
|
)
|
(142,540,084
|
)
|
Deemed dividend
associated with beneficial conversion of preferred stock
|
|
|
|
|
|
(11,423,824
|
)
|
Preferred stock
dividends
|
|
|
|
|
|
(1,589,861
|
)
|
Net loss
attributable to common shareholders
|
|
$
|
(28,480,725
|
)
|
$
|
(24,721,045
|
)
|
$
|
(155,553,769
|
)
|
Per share
information:
|
|
|
|
|
|
|
|
Loss from
continuing operationsbasic and diluted
|
|
$
|
(0.85
|
)
|
$
|
(0.54
|
)
|
$
|
(7.41
|
)
|
Loss from
discontinued operationsbasic and diluted
|
|
(0.05
|
)
|
(0.28
|
)
|
(2.55
|
)
|
Deemed dividend
associated with beneficial conversion of preferred stock
|
|
|
|
|
|
(0.80
|
)
|
Preferred stock
dividends
|
|
|
|
|
|
(0.11
|
)
|
Net loss per
common sharebasic and diluted
|
|
$
|
(0.90
|
)
|
$
|
(0.82
|
)
|
$
|
(10.87
|
)
|
Weighted average
number of basic and diluted common shares outstanding
|
|
31,561,344
|
|
30,291,607
|
|
14,310,868
|
|
The accompanying notes are an integral part of these consolidated
financial statements.
3
Isolagen, Inc.
(A Development Stage Company)
Consolidated Statements of
Shareholders Equity (Deficit) and Comprehensive Loss
(Unaudited)
|
|
Series A
Preferred Stock
|
|
Series B
Preferred Stock
|
|
Common
Stock
|
|
Additional
|
|
Treasury
Stock
|
|
Accumulated
Other
|
|
Accumulated
Deficit
During
|
|
Total
Shareholders
|
|
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Paid-In
Capital
|
|
Number
of
Shares
|
|
Amount
|
|
Comprehensive
Income
|
|
Development
Stage
|
|
Equity
(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.
4
|
|
Series A
Preferred Stock
|
|
Series B
Preferred Stock
|
|
Common
Stock
|
|
Additional
|
|
Treasury
Stock
|
|
Accumulated
Other
|
|
Accumulated
Deficit
During
|
|
Total
Shareholders
|
|
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Paid-In
Capital
|
|
Number
of
Shares
|
|
Amount
|
|
Comprehensive
Income
|
|
Development
Stage
|
|
Equity
(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.
5
|
|
Series A
Preferred Stock
|
|
Series B
Preferred Stock
|
|
Common
Stock
|
|
Additional
|
|
Treasury
Stock
|
|
Accumulated
Other
|
|
Accumulated
Deficit
During
|
|
Total
Shareholders
|
|
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Paid-In
Capital
|
|
Number
of
Shares
|
|
Amount
|
|
Comprehensive
Income
|
|
Development
Stage
|
|
Equity
(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.
6
|
|
Series A
Preferred Stock
|
|
Series B
Preferred Stock
|
|
Common
Stock
|
|
Additional
|
|
Treasury
Stock
|
|
Accumulated
Other
|
|
Accumulated
Deficit
During
|
|
Total
Shareholders
|
|
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Paid-In
Capital
|
|
Number
of
Shares
|
|
Amount
|
|
Comprehensive
Income
|
|
Development
Stage
|
|
Equity
(Deficit)
|
|
Uncompensated
contribution of services3rd 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 services4th 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 services1st 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 services2nd 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 services3rd quarter
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000
|
|
|
|
|
|
|
|
|
|
100,000
|
|
Uncompensated
contribution of services4th 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.
7
|
|
Series A
Preferred Stock
|
|
Series B
Preferred Stock
|
|
Common
Stock
|
|
Additional
|
|
Treasury
Stock
|
|
Accumulated
Other
|
|
Accumulated
Deficit
During
|
|
Total
Shareholders
|
|
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Paid-In
Capital
|
|
Number
of
Shares
|
|
Amount
|
|
Comprehensive
Income
|
|
Development
Stage
|
|
Equity
(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 services1st 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 stock2nd qtr
|
|
(70,954
|
)
|
(72
|
)
|
|
|
|
|
147,062
|
|
147
|
|
40,626
|
|
|
|
|
|
|
|
|
|
40,701
|
|
Conversion of
warrants into common stock2nd qtr
|
|
|
|
|
|
|
|
|
|
114,598
|
|
114
|
|
(114
|
)
|
|
|
|
|
|
|
|
|
|
|
Uncompensated
contribution of services2nd 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 cash3
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 stock3
rd
qtr
|
|
(2,967,553
|
)
|
(2,967
|
)
|
(155,750
|
)
|
(156
|
)
|
7,188,793
|
|
7,189
|
|
(82,875
|
)
|
|
|
|
|
|
|
|
|
(78,809
|
)
|
Conversion of
warrants into Common stock3
rd
qtr
|
|
|
|
|
|
|
|
|
|
212,834
|
|
213
|
|
(213
|
)
|
|
|
|
|
|
|
|
|
|
|
Compensation
expense on warrants issued to non-employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
412,812
|
|
|
|
|
|
|
|
|
|
412,812
|
|
Issuance of
common stock for cash4
th
qtr
|
|
|
|
|
|
|
|
|
|
136,500
|
|
137
|
|
279,363
|
|
|
|
|
|
|
|
|
|
279,500
|
|
Conversion of
warrants into Common stock4
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.
8
|
|
Series A
Preferred Stock
|
|
Series B
Preferred Stock
|
|
Common
Stock
|
|
Additional
|
|
Treasury
Stock
|
|
Accumulated
Other
|
|
Accumulated
Deficit
During
|
|
Total
Shareholders
|
|
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Paid-In
Capital
|
|
Number
of
Shares
|
|
Amount
|
|
Comprehensive
Income
|
|
Development
Stage
|
|
Equity
(Deficit)
|
|
Conversion of
warrants into common stock1
st
qtr
|
|
|
|
$
|
|
|
|
|
$
|
|
|
78,526
|
|
$
|
79
|
|
$
|
(79
|
)
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Issuance of
common stock for cash in connection with exercise of stock options1
st
qtr
|
|
|
|
|
|
|
|
|
|
15,000
|
|
15
|
|
94,985
|
|
|
|
|
|
|
|
|
|
95,000
|
|
Issuance of
common stock for cash in connection with exercise of warrants1
st
qtr
|
|
|
|
|
|
|
|
|
|
4,000
|
|
4
|
|
7,716
|
|
|
|
|
|
|
|
|
|
7,720
|
|
Compensation
expense on options and warrants issued to non-employees and directors1
st
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,410,498
|
|
|
|
|
|
|
|
|
|
1,410,498
|
|
Issuance of
common stock in connection with exercise of warrants2
nd
qtr
|
|
|
|
|
|
|
|
|
|
51,828
|
|
52
|
|
(52
|
)
|
|
|
|
|
|
|
|
|
|
|
Issuance of
common stock for cash2
nd
qtr
|
|
|
|
|
|
|
|
|
|
7,200,000
|
|
7,200
|
|
56,810,234
|
|
|
|
|
|
|
|
|
|
56,817,434
|
|
Compensation
expense on options and warrants issued to non-employees and directors2
nd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143,462
|
|
|
|
|
|
|
|
|
|
143,462
|
|
Issuance of
common stock in connection with exercise of warrants3
rd
qtr
|
|
|
|
|
|
|
|
|
|
7,431
|
|
7
|
|
(7
|
)
|
|
|
|
|
|
|
|
|
|
|
Issuance of
common stock for cash in connection with exercise of stock options3
rd
qtr
|
|
|
|
|
|
|
|
|
|
110,000
|
|
110
|
|
189,890
|
|
|
|
|
|
|
|
|
|
190,000
|
|
Issuance of
common stock for cash in connection with exercise of warrants3
rd
qtr
|
|
|
|
|
|
|
|
|
|
28,270
|
|
28
|
|
59,667
|
|
|
|
|
|
|
|
|
|
59,695
|
|
Compensation
expense on options and warrants issued to non-employees and directors3
rd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
229,133
|
|
|
|
|
|
|
|
|
|
229,133
|
|
Issuance of
common stock in connection with exercise of warrants4
th
qtr
|
|
|
|
|
|
|
|
|
|
27,652
|
|
28
|
|
(28
|
)
|
|
|
|
|
|
|
|
|
|
|
Compensation
expense on options and warrants issued to non-employees, employees, and
directors4
th
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
127,497
|
|
|
|
|
|
|
|
|
|
127,497
|
|
Purchase of
treasury stock4
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.
9
|
|
Series A
Preferred Stock
|
|
Series B
Preferred Stock
|
|
Common
Stock
|
|
Additional
|
|
Treasury
Stock
|
|
Accumulated
Other
|
|
Accumulated
Deficit
During
|
|
Total
Shareholders
|
|
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Paid-In
Capital
|
|
Number
of
Shares
|
|
Amount
|
|
Comprehensive
Income (Loss)
|
|
Development
Stage
|
|
Equity
(Deficit)
|
|
Issuance of
common stock for cash in connection with exercise of stock options1
st
qtr
|
|
|
|
$
|
|
|
|
|
$
|
|
|
25,000
|
|
$
|
25
|
|
$
|
74,975
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
75,000
|
|
Compensation
expense on options and warrants issued to non-employees1
st
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,565
|
|
|
|
|
|
|
|
|
|
33,565
|
|
Conversion of
warrants into common stock2
nd
qtr
|
|
|
|
|
|
|
|
|
|
27,785
|
|
28
|
|
(28
|
)
|
|
|
|
|
|
|
|
|
|
|
Compensation
expense on options and warrants issued to non-employees2
nd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(61,762
|
)
|
|
|
|
|
|
|
|
|
(61,762
|
)
|
Compensation
expense on options and warrants issued to non-employees3
rd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(137,187
|
)
|
|
|
|
|
|
|
|
|
(137,187
|
)
|
Conversion of
warrants into common stock3
rd
qtr
|
|
|
|
|
|
|
|
|
|
12,605
|
|
12
|
|
(12
|
)
|
|
|
|
|
|
|
|
|
|
|
Compensation
expense on options and warrants issued to non-employees4
th
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,844
|
|
|
|
|
|
|
|
|
|
18,844
|
|
Compensation
expense on acceleration of options4
th
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,950
|
|
|
|
|
|
|
|
|
|
14,950
|
|
Compensation
expense on restricted stock award issued to employee4
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.
10
|
|
Series A
Preferred Stock
|
|
Series B
Preferred Stock
|
|
Common
Stock
|
|
Additional
|
|
Treasury
Stock
|
|
Accumulated
Other
|
|
Accumulated
Deficit
During
|
|
Total
Shareholders
|
|
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Paid-In
Capital
|
|
Number
of
Shares
|
|
Amount
|
|
Comprehensive
Income (Loss)
|
|
Development
Stage
|
|
Equity
(Deficit)
|
|
Compensation
expense on options and warrants issued to non-employees1
st
qtr
|
|
|
|
$
|
|
|
|
|
$
|
|
|
|
|
$
|
|
|
$
|
42,810
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
42,810
|
|
Compensation
expense on option awards issued to employee and directors1
st
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46,336
|
|
|
|
|
|
|
|
|
|
46,336
|
|
Compensation
expense on restricted stock issued to employees1
st
qtr
|
|
|
|
|
|
|
|
|
|
128,750
|
|
129
|
|
23,368
|
|
|
|
|
|
|
|
|
|
23,497
|
|
Compensation
expense on options and warrants issued to non-employees2
nd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,177
|
|
|
|
|
|
|
|
|
|
96,177
|
|
Compensation
expense on option awards issued to employee and directors2
nd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
407,012
|
|
|
|
|
|
|
|
|
|
407,012
|
|
Compensation
expense on restricted stock to employees2
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 options2
nd
qtr
|
|
|
|
|
|
|
|
|
|
10,000
|
|
10
|
|
16,490
|
|
|
|
|
|
|
|
|
|
16,500
|
|
Compensation
expense on options and warrants issued to non-employees3
rd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,627
|
|
|
|
|
|
|
|
|
|
25,627
|
|
Compensation
expense on option awards issued to employee and directors3
rd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
389,458
|
|
|
|
|
|
|
|
|
|
389,458
|
|
Compensation
expense on restricted stock to employees3
rd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,605
|
|
|
|
|
|
|
|
|
|
3,605
|
|
Issuance of
common stock for cash in connection with exercise of stock options3
rd
qtr
|
|
|
|
|
|
|
|
|
|
76,000
|
|
76
|
|
156,824
|
|
|
|
|
|
|
|
|
|
156,900
|
|
Compensation
expense on options and warrants issued to non-employees4
th
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,772
|
|
|
|
|
|
|
|
|
|
34,772
|
|
Compensation
expense on option awards issued to employee and directors4
th
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
390,547
|
|
|
|
|
|
|
|
|
|
390,547
|
|
Compensation
expense on restricted stock to employees4
th
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88
|
|
|
|
|
|
|
|
|
|
88
|
|
Cancellation of
unvested restricted stock award4
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.
11
|
|
Series A
Preferred Stock
|
|
Series B
Preferred Stock
|
|
Common
Stock
|
|
Additional
|
|
Treasury
Stock
|
|
Accumulated
Other
|
|
Accumulated
Deficit
During
|
|
Total
Shareholders
|
|
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Number
of
Shares
|
|
Amount
|
|
Paid-In
Capital
|
|
Number
of
Shares
|
|
Amount
|
|
Comprehensive
Income (Loss)
|
|
Development
Stage
|
|
Equity
(Deficit)
|
|
Compensation
expense on options and warrants issued to non-employees1
st
qtr
|
|
|
|
$
|
|
|
|
|
$
|
|
|
|
|
$
|
|
|
$
|
39,742
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
39,742
|
|
Compensation
expense on option awards issued to employee and directors1
st
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
448,067
|
|
|
|
|
|
|
|
|
|
448,067
|
|
Compensation
expense on restricted stock issued to employees1
st
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88
|
|
|
|
|
|
|
|
|
|
88
|
|
Issuance of
common stock for cash in connection with exercise of stock options1
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-employees2
nd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39,981
|
|
|
|
|
|
|
|
|
|
39,981
|
|
Compensation
expense on option awards issued to employee and directors2
nd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
462,363
|
|
|
|
|
|
|
|
|
|
462,363
|
|
Compensation expense on restricted stock issued to
employees2
nd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88
|
|
|
|
|
|
|
|
|
|
88
|
|
Compensation
expense on option awards issued to employee and directors3
rd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
478,795
|
|
|
|
|
|
|
|
|
|
478,795
|
|
Compensation
expense on restricted stock issued to employees3
rd
qtr
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88
|
|
|
|
|
|
|
|
|
|
88
|
|
Issuance of
common stock upon exercise of warrants3
rd
qtr
|
|
|
|
|
|
|
|
|
|
492,613
|
|
493
|
|
893,811
|
|
|
|
|
|
|
|
|
|
894,304
|
|
Issuance of
common stock for cash, net of offering costs3
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 options3
rd
qtr
|
|
|
|
|
|
|
|
|
|
1,666
|
|
2
|
|
3,164
|
|
|
|
|
|
|
|
|
|
3,166
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(28,480,725
|
)
|
(28,480,725
|
)
|
Other
comprehensive gain, foreign currency translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
481,312
|
|
|
|
481,312
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(27,999,413
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 9/30/07
|
|
|
|
$
|
|
|
|
|
$
|
|
|
41,639,657
|
|
$
|
41,640
|
|
$
|
128,829,716
|
|
4,000,000
|
|
$
|
(25,974,000
|
)
|
$
|
353,850
|
|
$
|
(155,553,769
|
)
|
$
|
(52,302,563
|
)
|
The accompanying notes are an integral part of these consolidated
financial statements.
12
Isolagen, Inc.
(A Development Stage Company)
Consolidated Statements of Cash Flows
(Unaudited)
|
|
Nine Months Ended
September 30,
|
|
Cumulative
Period from
December 28,
1995 (date of
inception) to
September 30,
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(28,480,725
|
)
|
$
|
(24,721,045
|
)
|
$
|
(142,540,084
|
)
|
Adjustments to
reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
Expense related
to equity awards
|
|
2,647,694
|
|
1,038,732
|
|
7,514,034
|
|
Uncompensated
contribution of services
|
|
|
|
|
|
755,556
|
|
Depreciation and
amortization
|
|
1,127,949
|
|
1,612,180
|
|
7,337,858
|
|
Provision for
doubtful accounts
|
|
11,732
|
|
61,054
|
|
330,047
|
|
Amortization of
debt issue costs
|
|
561,929
|
|
561,930
|
|
2,185,281
|
|
Amortization of
debt discounts on investments
|
|
|
|
|
|
(508,983
|
)
|
Loss on disposal
or impairment of property and equipment
|
|
20,803
|
|
718,405
|
|
4,570,034
|
|
Foreign exchange
gain on substantial liquidation of foreign entity
|
|
|
|
|
|
(133,851
|
)
|
Minority
interest
|
|
(282,846
|
)
|
(27,838
|
)
|
(360,978
|
)
|
Change in
operating assets and liabilities, excluding effects of acquisition:
|
|
|
|
|
|
|
|
Decrease (Increase)
in restricted cash
|
|
763,152
|
|
719,630
|
|
(720,045
|
)
|
Decrease
(increase) in accounts receivable
|
|
(94,111
|
)
|
875,239
|
|
(63,303
|
)
|
Decrease in
other receivables
|
|
291,914
|
|
32,168
|
|
171,478
|
|
Decrease
(increase) in inventory
|
|
(425,457
|
)
|
129,162
|
|
(628,034
|
)
|
Decrease
(increase) in prepaid expenses
|
|
773,182
|
|
588,189
|
|
(316,426
|
)
|
Decrease
(increase) in other assets
|
|
99,551
|
|
(13,248
|
)
|
117,906
|
|
Increase
(decrease) in accounts payable
|
|
(563,465
|
)
|
(942,579
|
)
|
629,627
|
|
Increase
(decrease) in accrued expenses and other liabilities
|
|
887,472
|
|
(65,128
|
)
|
4,500,942
|
|
Decrease in
deferred revenue
|
|
(317,008
|
)
|
(1,251,013
|
)
|
(18,462
|
)
|
Net cash used in
operating activities
|
|
(22,978,234
|
)
|
(20,684,162
|
)
|
(117,177,403
|
)
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
Acquisition of
Agera, net of cash acquired
|
|
|
|
(2,009,841
|
)
|
(2,009,841
|
)
|
Purchase of
property and equipment
|
|
(126,460
|
)
|
(1,031,991
|
)
|
(25,423,755
|
)
|
Proceeds from
the sale of property and equipment
|
|
925
|
|
6,595
|
|
41,820
|
|
Purchase of
investments
|
|
|
|
(2,700,000
|
)
|
(152,998,313
|
)
|
Proceeds from
sales and maturities of investments
|
|
|
|
25,700,000
|
|
153,507,000
|
|
Net cash
provided by (used in) investing activities
|
|
(125,535
|
)
|
19,964,763
|
|
(26,883,089
|
)
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
Proceeds from
convertible debt
|
|
|
|
|
|
91,450,000
|
|
Offering costs
associated with the issuance of convertible debt
|
|
|
|
|
|
(3,746,193
|
)
|
Proceeds from
notes payable to shareholders, net
|
|
|
|
|
|
135,667
|
|
Proceeds from
the issuance of preferred stock, net
|
|
|
|
|
|
12,931,800
|
|
Proceeds from
the issuance of common stock, net
|
|
14,672,737
|
|
173,400
|
|
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
|
|
14,672,737
|
|
173,400
|
|
167,326,996
|
|
Effect of
exchange rate changes on cash balances
|
|
(751
|
)
|
(65,326
|
)
|
85,258
|
|
Net increase
(decrease) in cash and cash equivalents
|
|
(8,431,783
|
)
|
(611,325
|
)
|
23,351,762
|
|
Cash and cash
equivalents, beginning of period
|
|
31,783,545
|
|
41,554,203
|
|
|
|
Cash and cash
equivalents, end of period
|
|
$
|
23,351,762
|
|
$
|
40,942,878
|
|
$
|
23,351,762
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosures of cash flow information:
|
|
|
|
|
|
|
|
Cash paid for
interest
|
|
$
|
1,575,000
|
|
$
|
1,575,000
|
|
$
|
7,990,283
|
|
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
|
|
The accompanying notes are an integral part of these consolidated
financial statements.
13
Isolagen, Inc.
(A Development Stage Company)
Notes to Consolidated Financial
Statements
Note 1Basis
of Presentation, Business and Organization
Isolagen, Inc.
f/k/a American Financial Holding, Inc., a Delaware corporation (Isolagen)
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.
T
he accompanying consolidated financial statements should be read in
conjunction with the Companys consolidated financial statements and footnotes
contained within the Companys Report of Form 8-K/A filed with the Securities
and Exchange Commission (SEC) on August 14, 2007. That Form 8-K/A contained
financial information which had been retrospectively adjusted from the
information appearing in the Companys Annual Report on Form 10-K for the year
ended December 31, 2006 to reflect the treatment of the United Kingdom,
Switzerland and Australian operations as discontinued operations (see Note 4).
Specifically retrospectively adjusted in the Form 8-K/A filed on August 14,
2007 were the Selected Financial Data, Managements Discussion and Analysis of
Financial Condition and Results of Operations, Quantitative and Qualitative
Disclosures about Market Risk and the Companys consolidated financial
statements.
The Company is an aesthetic
and therapeutic company focused on developing novel skin and tissue
rejuvenation products. The Companys 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 patients own, or autologous, fibroblast
cells produced in the Companys 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 Ageras 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 agencys Special
Protocol Assessment (SPA) regulations. Pursuant to this assessment process,
the FDA has agreed that the Companys 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.
In March 2004, the
Company announced positive results of a first Phase III exploratory clinical
trial for the Companys lead facial aesthetics product candidate, and in July
2004 we 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 we 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.
14
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 4.
Through
September 30, 2007, the Company has been primarily engaged in developing its
initial product technology and recruiting personnel. 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
Companys ability to continue as a going concern. The Companys ability to
operate profitably is largely contingent upon its success in 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 in the future 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, or on satisfactory terms or at all. Additionally, no
assurance can be given that any such financing, if obtained, will be adequate
to meet the Companys ultimate capital needs and to support the Companys
growth. If adequate capital cannot be obtained on satisfactory terms, the
Companys operations would be 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 Companys
expanding operations. In addition, the Companys 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 Companys
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. (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, a Delaware
corporation, 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 operations and cash flows of AFH and Gemini are
included in the unaudited, cumulative consolidated statements of operations and
cash flows from August 10, 2001 onward.
15
The consolidated financial statements included
herein as of September 30, 2007, and for each of the three and nine months
ended September 30, 2007 and 2006, 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 Securities and Exchange
Commission. 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 nine months ended
September 30, 2007, are not necessarily indicative of the results which will be
realized for the year ending December 31, 2007.
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 2Going
Concern
At September 30, 2007 and December 31,
2006, the Company had cash, cash equivalents and restricted cash of $24.1
million and $33.3 million, respectively. The Company believes that its existing
capital resources are adequate to finance its operations through at least June
30, 2008. The Company estimates that it will require additional cash resources
during the third quarter of 2008 based upon its current operating plan and condition.
This estimate excludes any proceeds that would be realized upon the sale of the
Swiss corporate campus (see further discussion below and at Note 3).
Through
September 30, 2007, the Company
has been primarily engaged in developing its initial product technology and
recruiting personnel. 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, there exists substantial doubt about the
Companys ability to continue as a going concern. The Companys ability to
operate profitably is largely contingent upon its success in 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 in the future 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, or on satisfactory terms or at all. Additionally, no
assurance can be given that any such financing, if obtained, will be adequate
to meet the Companys ultimate capital needs and to support the Companys
growth. If adequate capital cannot be obtained on satisfactory terms, the
Companys operations would be negatively impacted.
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 allowed 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 6,746,646 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
of common stock pursuant to this shelf registration.
The
Companys 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
markets reception of the Company and the offering terms. The Companys ability
to commence an offering may be dependent on its ability to complete the
registration process, which is subject to the SECs regulatory calendar, as
well as the Companys ability to timely respond to any SEC comments that have
been or may be issued. The Company is also continuing its efforts to sell its
Swiss corporate campus (see Note 3). The Company will add any proceeds from the
sale of the Swiss corporate campus to its working capital, which would
partially alleviate the Companys need to obtain financing from other sources
.
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.
16
As a
result of the above discussed conditions, and in accordance with generally
accepted accounting principles in the United States, there exists substantial
doubt about the Companys ability to continue as a going concern, and the
Companys ability to continue as a going concern is contingent upon its ability
to secure additional adequate financing or capital prior to or during the third
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 affect on the Companys
operations, the realization of its assets and the timely satisfaction of its
liabilities. The Companys 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 3Summary
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 Companys 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 income in shareholders
equity. Gains and losses resulting from foreign currency transactions are
included in earnings and have not been material in any one period.
Balances
of related after-tax components comprising accumulated other comprehensive
income included in shareholders equity at September 30, 2007 and
December 31, 2006 are related 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.
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 original
maturities of three months or less) to be cash equivalents. At September 30,
2007 and December 31, 2006, the Company had $0.7 million and $1.5 million of
cash restricted for the payment of its Exton, Pennsylvania facility lease.
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 invests its
cash equivalent funds primarily in U.S. government securities.
17
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
Inventory
of Agera consists of packaging components and finished goods. Agera purchases
its packaging components from a third-party, and its final finished goods
inventory is purchased from a contract manufacturer. As such, Agera does not
maintain work in progress inventory. Agera accounts for its inventory on the
first-in-first-out method.
Assets of
discontinued operations held for sale
In
April 2005, the Company acquired land and a two-building, 100,000 square foot
corporate campus in Bevaix, Canton of Neuchâtel, Switzerland for $10 million.
The Company subsequently spent approximately $1.8 million on the first phase of
a renovation. In April 2006, management decided to place the corporate campus
on the market for sale in order to conserve capital. The Company commenced its
selling efforts during June of 2006. As of September 30, 2007, the net book
value of the corporate campus was $10.8 million, reflecting managements
estimate of the realizable value of the corporate campus. The corporate campus
is included in assets of discontinued operations held for sale on the
consolidated balance sheets for all periods presented.
Although
the corporate campus was not being actively marketed for sale as of March 31, 2006
and therefore had not been reclassified as held for sale as of March 31, 2006,
at that date management assessed whether the book value of the corporate campus
was impaired based on its estimate of the realizable value of the corporate
campus, and made a determination to write down the corporate campus by $0.7
million. The Company subsequently recorded a further impairment charge of $0.4
million during the fourth quarter of 2006 to reflect managements estimate of
the realizable value of the corporate campus at December 31, 2006. Accordingly,
total impairment charges of $1.1 million have been recorded related to the
Switzerland corporate campus, which charges are reflected in loss from
discontinuing operations in the consolidated statement of operations.
In
March 2007, the Company completed the closing of its United Kingdom
manufacturing facility. As described in Note 4, the Company recorded a fixed
asset impairment charge related to its United Kingdom operation of $1.4 million
during the fourth quarter of 2006, which is included in loss from discontinued
operations in the cumulative consolidated statement of operations. The carrying
value of the impaired United Kingdom fixed assets is less than $0.2 million at
September 30, 2007, reflecting managements estimate of realizable value. The
United Kingdom fixed assets are included in assets of discontinued operations
held for sale on the accompanying consolidated balance sheets for all periods
presented (see Note 4 for further discussion of the Companys discontinued
operations).
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
I
ntangible assets primarily include
proprietary formulations and trademarks, which were acquired in connection with
the acquisition of Agera (see Note 5), as well as certain in-process patents.
Proprietary formulations
18
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 continually 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.
Intangible
assets are comprised as follows:
|
|
September 30,
|
|
December 31,
|
|
|
|
2007
|
|
2006
|
|
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
|
|
(626,926
|
)
|
(381,795
|
)
|
Intangible
assets, net
|
|
$
|
4,691,374
|
|
$
|
4,936,505
|
|
Debt
Issue Costs
The
costs incurred in issuing the Companys 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. Debt
issuance costs, net of amortization, were approximately $1.6 million at
September 30, 2007 and approximately $2.1 million at December 31, 2006 and were
included in other assets, net, in the accompanying consolidated balance sheets.
The Company filed
registration statements on Form S-3 and Form S-4 (the Combined Registration
Statements) during July 2007. The Combined Registration Statements related to
(1) a proposed exchange offer of new 3.5% convertible senior notes due 2024 to
the holders of the currently outstanding $90 million, in principal amount, 3.5%
convertible subordinated notes due 2024 and (2) a proposed offer to the public
of an additional $30 million, in principal amount, of new 3.5% convertible
senior notes due 2024. In August, 2007 the Company decided not to proceed with
the offerings covered by the Combined Registration Statements, and the Combined
Registration Statements were subsequently withdrawn by the Company in August
2007 prior to being declared effective by the SEC. During the nine months ended
September 30, 2007, the Company incurred $0.8 million of costs related to the
Combined Registration Statements. As a result of the Companys withdrawal of
the Combined Registration Statements in August 2007, such $0.8 million of costs
were expensed and are included in selling, general and administrative expenses
in the consolidated statement of operations for the three and nine months ended
September 30, 2007.
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 Ageras 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 our customer at that time, the fee is fixed and
determinable and collection is reasonably assured. Any advanced payments are
deferred until shipment.
19
Discontinued operations:
The Isolagen
Therapy was administered, in the United Kingdom, to each patient using a
recommended regimen of injections. Due to the short shelf life, each injection
is 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 patients 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 is 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 our 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. If the physician discontinued the regimen
prematurely, all remaining deferred revenue was recognized. Since the closure
of the United Kingdom operation on March 31, 2007, Isolagen Therapy has only
been administered in connection with clinical trials, and as such, has had no
associated revenue earned or recognized after that date.
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
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.
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 costs. 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
20
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 (refer to Note 8 for
further stock-based compensation discussion).
Income
taxes
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 September
30, 2007, the Company has 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 the adoption date of
January 1, 2007, we had $40.4 million of unrecognized tax benefits, all of
which would affect our effective tax rate if recognized. At September 30, 2007,
the Company has $50.7 million of unrecognized tax benefits, the large majority
of which relates to loss carryforwards for which we have provided a full
valuation allowance. The tax years 2003 through 2006 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 periods in which it incurred net losses as the effect is
antidilutive.
At
September 30, 2007, options and warrants to purchase 8.8 million 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, 9.8 million shares issuable
upon the conversion of the Companys convertible notes, at a conversion price
of approximately $9.16, were not included as their effect would be
antidilutive.
At
September 30, 2006, options and warrants to purchase 11.1 million shares of
common stock at exercise prices ranging from $1.50 to $11.38 per share were outstanding,
but were not included in the computation of diluted earnings per share as their
effect would be antidilutive. Also, 9.8 million shares issuable upon the
conversion of the Companys convertible notes, at a conversion price of
approximately $9.16, were not included as their effect would be antidilutive.
21
Comprehensive
loss
Comprehensive
loss encompasses all changes in equity other than those with shareholders and
consists of net loss and foreign currency translation adjustments and
unrealized gains and losses on available-for-sale marketable debt securities.
The Company does not provide for U.S. income taxes on foreign currency
translation adjustments since it does not provide for such taxes on undistributed
earnings of foreign subsidiaries.
|
|
Three Months Ended September 30,
|
|
|
|
2007
|
|
2006
|
|
Net loss
|
|
$
|
(7,798,473
|
)
|
$
|
(6,671,880
|
)
|
Other
comprehensive income (loss), foreign currency translation adjustment
|
|
574,167
|
|
(51,286
|
)
|
Comprehensive
loss
|
|
$
|
(7,224,306
|
)
|
$
|
(6,723,166
|
)
|
|
|
Nine Months Ended September 30,
|
|
|
|
2007
|
|
2006
|
|
Net loss
|
|
$
|
(28,480,725
|
)
|
$
|
(24,721,045
|
)
|
Other
comprehensive income (loss), foreign currency translation adjustment
|
|
481,312
|
|
434,117
|
|
Comprehensive
loss
|
|
$
|
(27,999,413
|
)
|
$
|
(24,286,928
|
)
|
Fair
Value of Financial Instruments
The
Companys primary financial instruments consist of accounts receivable,
accounts payable and convertible subordinated debentures. The fair values of
the Companys accounts receivable and accounts payable approximate, in the
Companys opinion, their respective carrying amounts. The Companys convertible
subordinated debentures were quoted at approximately 80% and 73% of par value
at September 30, 2007 and December 31, 2006, respectively. Accordingly, the
fair value of our convertible subordinated debentures was approximately $72.0
million and $65.7 million at September 30, 2007 and December 31, 2006,
respectively.
Recently
Issued Accounting Standards Not Yet Effective
In September 2006, the FASB issued SFAS No. 157, Fair
Value Measurement, which is effective for the Companys fiscal year beginning
January 1, 2008. This Statement defines fair value, establishes a framework for
measuring fair value and expands disclosures about fair value measurements.
This Statement does not require any new fair value measurements, but simplifies
and codifies related guidance within GAAP. This Statement applies under other
accounting pronouncements that require or permit fair value measurements. The
adoption of this statement is not currently expected to have a material impact
on the Companys financial position or results of operations.
In
February 2007, the FASB issued Statement No. 159, The Fair Value
Option for Financial Assets and Financial Liabilities (SFAS 159). SFAS 159
allows entities the option to measure eligible financial instruments at fair
value as of specified dates. Such election, which may be applied on an
instrument by instrument basis, is typically irrevocable once elected. SFAS 159
is effective for fiscal years beginning after November 15, 2007, and early
application is allowed under certain circumstances. The Company is currently
evaluating the impact SFAS 159 will have on its consolidated financial
position.
Note 4Discontinued
Operations
As
part of the Companys continuing efforts to evaluate the best uses of its
resources, in the fourth quarter of 2006 the Companys Board of Directors
approved the proposed closing of the Companys United Kingdom operation. After
a full business analysis, management and the Board determined that the best use
of resources was to focus on the Companys strategic opportunities. As such,
the Companys first priority is to advance the United States pivotal Phase III
clinical trial for the use of Isolagen Therapy for the treatment of certain
facial wrinkles, and then, with regulatory agencies agreement, initiate
clinical studies in other therapeutic and aesthetic areas.
22
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 are under operating leases. The
manufacturing site lease expires February 2010 and, as of September 30, 2007,
the remaining lease obligation approximated $0.5 million. The administrative
site lease expired April 2007. As of September 30, 2007, fixed assets of less than $0.2 million related
to the United Kingdom operations are reflected as assets held for sale of
discontinued operations on the consolidated balance sheet.
The 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.
The following sets forth the components of assets
and liabilities of discontinued operations as of
September 30, 2007 and December 31, 2006:
|
|
September 30,
|
|
December 31,
|
|
(in millions)
|
|
2007
|
|
2006
|
|
Inventory
|
|
$
|
|
|
$
|
0.1
|
|
Value-added tax
refund due
|
|
|
|
0.3
|
|
Other current
assets
|
|
|
|
0.3
|
|
Total current
assets
|
|
|
|
0.7
|
|
Assets held for
sale
|
|
11.0
|
|
10.5
|
|
Long term assets
|
|
0.1
|
|
0.2
|
|
Total assets
|
|
$
|
11.1
|
|
$
|
11.4
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
0.0
|
|
$
|
0.5
|
|
Accrued expenses
and other current liabilities
|
|
0.2
|
|
1.4
|
|
Total current
liabilities
|
|
0.2
|
|
1.9
|
|
Long term
liabilities
|
|
0.2
|
|
0.1
|
|
Total
liabilities
|
|
$
|
0.4
|
|
$
|
2.0
|
|
The following sets forth the results of operations
of discontinued operations for the three months ended
September 30, 2007 and September 30, 2006:
|
|
Three Months Ended September 30,
|
|
(in millions)
|
|
2007
|
|
2006
|
|
Net revenue
|
|
$
|
|
|
$
|
1.4
|
|
Gross loss
|
|
|
|
(0.3
|
)
|
Operating loss
|
|
(0.2
|
)
|
(1.9
|
)
|
Other income
|
|
0.1
|
|
0.1
|
|
Loss from
discontinued operations
|
|
$
|
(0.1
|
)
|
$
|
(1.8
|
)
|
The following sets forth the results of operations
of discontinued operations for the nine months ended
September 30, 2007 and September 30, 2006:
|
|
Nine Months Ended September 30,
|
|
(in millions)
|
|
2007
|
|
2006
|
|
Net revenue
|
|
$
|
0.2
|
|
$
|
4.8
|
|
Gross loss
|
|
(0.3
|
)
|
(0.8
|
)
|
Operating loss
|
|
(1.7
|
)
|
(8.8
|
)
|
Other income
|
|
0.2
|
|
0.3
|
|
|
|
|
|
|
|
Loss from
discontinued operations
|
|
$
|
(1.5
|
)
|
$
|
(8.5
|
)
|
23
In addition to the
results of operations of discontinued operations set forth above, the following
sets forth information about the major components of the United Kingdom
operation exit costs incurred through September 30, 2007:
|
|
Costs Incurred,
|
|
|
|
|
|
Nine Months Ended
|
|
Cumulative
Costs
|
|
|
|
September 30, 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 United Kingdom accrued exit costs for the
nine months ended September 30, 2007:
|
|
Accrued Liability
|
|
Costs Charged
|
|
Costs Paid
|
|
Accrued Liability
|
|
|
|
January 1, 2007
|
|
to Expense
|
|
or Settled
|
|
September 30, 2007
|
|
Employee
severance
|
|
$
|
284,096
|
|
$
|
183,222
|
|
$
|
467,318
|
|
$
|
|
|
Total
|
|
$
|
284,096
|
|
$
|
183,222
|
|
$
|
467,318
|
|
$
|
|
|
Excluding the manufacturing lease, which expires in
February 2010 unless terminated sooner, i
t is expected that the majority
of all remaining costs to be incurred will be recognized during 2007. However,
no assurances can be given with respect to the total cost of closing the United
Kingdom operation or the timing of such costs. The Company believes that the
amount of all future charges associated with the United Kingdom operation
shutdown, such as potential lease exit costs and professional fees, among other
items, cannot be precisely estimated at this time. However, as of September 30,
2007, remaining future charges are expected to be approximately
$0.6 million (both before and after tax), including $0.5 million of
remaining lease obligations, but excluding potential claims or contingencies
unknown or which cannot be estimated at this time.
Note 5Acquisition
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 Companys
Isolagen Therapy and will broaden the Companys 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
Ageras 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 Ageras
historical book values), and the results of Ageras 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 Ageras
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 Ageras
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. No amounts have yet
been paid with respect to the additional purchase price.
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.
24
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 longterm
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.
The unaudited pro forma financial information below
assumes that the Agera acquisition occurred on January 1 of the periods
presented and includes the effect of amortization of intangibles from that
date.
The unaudited pro forma results of operations are being furnished
solely for informational purposes and are not intended to represent or be
indicative of the consolidated results of operations that would have been
reported had these transactions been completed as of the dates and for the
periods presented, nor are they necessarily indicative of future results.
|
|
Three months ended,
|
|
Nine months ended,
|
|
(in millions, except per share data)
|
|
September 30, 2006
|
|
September 30, 2006
|
|
Pro forma
revenue
|
|
$
|
0.3
|
|
$
|
0.9
|
|
Pro forma net
loss
|
|
(6.7
|
)
|
(24.6
|
)
|
Pro forma basic
and diluted loss per share
|
|
$
|
(0.22
|
)
|
$
|
(0.81
|
)
|
Note 6Available-for-Sale
Investments
The
Company had no available-for-sale investments at September 30, 2007 or December
31, 2006, and as such, there were no sales of available-for-sale marketable
debt securities during the three and nine months ended September 30, 2007.
Proceeds from the sale of available-for-sale marketable debt securities were
$9.0 million and $25.7 million for the three and nine months ended September
30, 2006, respectively. No realized gains and losses (based on specific
identification) were included in the results of operations upon those sales.
Note 7Commitments
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
25
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.
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 Companys motions to
dismiss the complaint, and the Company expects the parties will commence
discovery shortly.
The Company intends to
defend these lawsuits vigorously. However, 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.
The Company has received
requests for reimbursement of costs of defense of approximately $0.3 million
from Mr. Jeffrey Tomz, the Companys former Chief Financial Officer, who is
named as a defendant in the litigation described above. The Company and Mr.
Tomz have a dispute with respect to the Companys indemnification obligations
to Mr. Tomz. The Companys view is that under its separation
agreement with Mr. Tomz it owes Mr. Tomz only those benefits required to
be provided to a former officer under Delaware law. Mr. Tomz view apparently
is that the Company owes him more than the minimum required by Delaware law and
is obliged to advance his costs of defense. In the event of a final
adjudication of a matter in which Mr. Tomz is a defendant, the Company will be
obliged to reimburse Mr. Tomz for the cost of defense, provided that he was
successful, he acted in good faith in the circumstances underlying the case,
and that his legal expenses are reasonable and are documented in a manner
proscribed by the Delaware courts. As previously disclosed, a final
determination in favor of all of the defendants, including Mr. Tomz, has been
made in one of the derivative actions filed against certain current and former
officers and directors, the
Fordyce
case. In the event that Mr. Tomz is able to satisfy the standards
described above for reimbursement of his legal defense costs incurred in
connection with the
Fordyce
case,
the Company will be obligated to pay them. To date the Company has not
reimbursed any of Mr. Tomz defense costs, and it has recorded no charge in its
consolidated statements of operation other than a reserve of approximately
$20,000 in connection with the
Fordyce
case.
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
26
the Company against
certain of the Companys 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. Certain individual
defendants are accused of improper trading in Isolagen stock. 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.
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 plaintiffs 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 plaintiffs motion to file a second amended complaint,
and from the April 10, 2007 order dismissing plaintiffs amended complaint
without prejudice. The parties are currently briefing the plaintiffs appeal.
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.
The Derivative Actions
are purportedly being prosecuted on behalf of the Company and any recovery
obtained, less any attorneys fees awarded, will go to 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.
27
On October 17, 2007, a
purported shareholder named Mr. Ronald Beattie sent a letter to the Companys
chairman and Chief Executive Officer demanding that the Company take action
against the former officers and directors named as defendants in the derivative
actions described above for purportedly wrongful acts materially identical to
those alleged in the derivative actions described above, and declaring he will
file a shareholder derivative action if the Company does not commence an action
on its own behalf within a reasonable time. The Company has not yet responded
to this letter.
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. Ciallellas 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. Ciallellas
legal claims relating to her termination;
(iii) $5,000 paid during
June 2007 in connection with Ms. Ciallellas release of claims under the Age
Discrimination in Employment Act;
(iv) $159,245 paid during
June 2007 for the reimbursement of Ms. Ciallellas legal fees in connection
with the negotiation and execution of the Settlement Agreement;
(v) $198,950 related to
Ms. Ciallellas legal support services to be provided to the Company, of which
approximately $55,000 had been paid as of September 30;
(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 during the three months ended
September 30, 2007. Accordingly, during the nine months ended September 30,
2007, the Company recorded total termination costs of approximately $4.6
million, as follows:
28
|
|
Three months ended,
|
|
Three months ended,
|
|
|
|
(in millions)
|
|
March 31, 2007
|
|
June 30, 2007
|
|
Total
|
|
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 discussed 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 Companys 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 our 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. Ciallellas
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 September 30, 2007, $0.6 million remains due to Ms. Ciallella
and is recorded in accrued expenses on the consolidated balance sheet.
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 Companys 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.
29
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 September 30,
2007, 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.
Subsequent
to the Companys 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 our treatment. To date, no legal court actions have been brought
against the Company since the closure of the United Kingdom operation, and no
provision has been recorded in the consolidated financial statements other than
that discussed in the preceding paragraph.
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 Companys financial
statements.
Note 8Equity-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. The Company
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.
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 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.
The Company utilizes the straight-line attribution
method for recognizing stock-based compensation expense under SFAS No. 123(R).
The Company recorded $0.5 million and $0.4 million of compensation expense, net
of tax, during the three months ended September 30, 2007 and September 30,
2006, respectively, for stock option awards made to employees and directors,
based on the estimated fair values at the grant dates of the awards. The
Company recorded $1.4 million and $0.8 million of compensation expense, net of
tax, during the nine months ended September 30, 2007 and September 30,
2006, respectively, for stock option awards made to employees and directors,
based on the estimated fair values at the grant dates of the awards. Further,
in connection with the separation agreement with the Companys former President
and related modification of the former Presidents stock options (see Note 7),
the Company recorded $1.1 million in stock option modification expense during
the three months ended March 31, 2007, as discussed further below.
30
The weighted average fair market value using the
Black-Scholes option-pricing model of the options granted was $1.91 and $1.35
for the nine months ended September 30, 2007 and September 30, 2006,
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:
|
|
Nine Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
2007
|
|
2006
|
|
Expected life (years)
|
|
4.0 years
|
|
5.5 years
|
|
Interest rate
|
|
4.9
|
%
|
4.9
|
%
|
Dividend yield
|
|
|
|
|
|
Volatility
|
|
76
|
%
|
80
|
%
|
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 Companys
historical experience. Expected life represents the period of time that options
are expected to be outstanding and is based on the Companys 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 Companys 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 (Revised 2004). 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 Companys
statements of operations in future periods.
There
were 16,666 stock options exercised during the nine months ended September 30,
2007, resulting in cash proceeds to the Company of approximately $26,265. The
options exercised had an intrinsic value of $17,133. There were 86,000 stock
options exercised during the nine months ended September 30, 2006,
resulting in cash proceeds to the Company of $0.2 million. The options
exercised had an intrinsic value of $0.2 million. A summary of option activity
for the nine months ended September 30, 2007 is as follows:
Options
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at January 1, 2007
|
|
10,474,833
|
|
$
|
4.17
|
|
|
|
|
|
Nine months ended September 30, 2007:
|
|
|
|
|
|
|
|
|
|
Granted
|
|
687,500
|
|
3.26
|
|
|
|
|
|
Exercised
|
|
(16,666
|
)
|
1.58
|
|
|
|
|
|
Forfeited
|
|
(2,508,334
|
)
|
5.75
|
|
|
|
|
|
Outstanding at September 30, 2007
|
|
8,637,333
|
|
3.65
|
|
5.43
|
|
$
|
2,988,670
|
|
Options exercisable at September 30, 2007
|
|
5,526,328
|
|
$
|
4.38
|
|
4.58
|
|
$
|
1,251,236
|
|
The following table
summarizes the status of the Companys non-vested stock options since January 1,
2007:
31
|
|
Non-vested Options
|
|
|
|
Number of
Shares
|
|
Weighted-
Average Fair
Value
|
|
Non-vested at January 1, 2007
|
|
3,571,089
|
|
$
|
1.41
|
|
Granted
|
|
687,500
|
|
1.91
|
|
Vested
|
|
(1,044,250
|
)
|
1.53
|
|
Forfeited
|
|
(103,334
|
)
|
1.36
|
|
Non-vested at September 30, 2007
|
|
3,111,005
|
|
1.49
|
|
|
|
|
|
|
|
|
The
total fair value of shares vested during the nine months ended September 30,
2007 and September 30, 2006 was $1.6 million and $0.8 million,
respectively. As of September 30, 2007 and December 31, 2006, there
were $2.6 million and $2.9 million of total unrecognized compensation cost,
respectively, related to non-vested director and employee stock options which
vest over time. That remaining cost at September 30, 2007 is expected to
be recognized over a weighted-average period of 1.9 years. As of September 30,
2007 and December 31, 2006, there was $1.1 million and $1.5 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 Companys common stock to be awarded through incentive and
non-qualified stock options and stock appreciation rights. The 2001 Stock Plan
is administered by the Compensation Committee of the Companys 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 September 30, 2007, there were 2,639,000 options outstanding under the
Stock Plan and 1,735,334 options available to be issued under the Stock Plan.
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 March 31,
2006, the Company issued to four independent Board of Director members, under
the 2001 Stock Plan, a total of 120,000 options to purchase its common stock
with an exercise price of $2.14 per share and a ten year maximum contractual
life. The options vested over the four fiscal quarters of 2006. Also during the
three months ended March 31, 2006, the Company issued, under the 2001
Stock Plan, a total of 10,000 options to purchase its common stock with an
exercise price of $1.84 per share to one employee with a five year maximum
contractual life. These options vest over a three year period from the date of
grant.
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. During the three months
ended June 30, 2006, the Company issued, under the 2001 Stock Plan, (1) a
total of 91,500 options to eight employees to purchase its common stock at
exercise prices ranging from $1.89 to $2.06 per share, which have a five year
maximum contractual life and which vest annually over a three year period from
the date of grant, (2) 160,000 options to purchase its common stock with
an exercise price of $1.89 per share to the Companys President, which have a
ten year maximum contractual life and which originally vested each fiscal
quarter end over a three year period from the date of grant (and which were
subsequently modified and fully vested in March 2007, as discussed below)
and (3) 50,000 options to purchase its common stock with an exercise price
of $1.89 per share to a non-employee service provider, which have a five year
maximum contractual life and which fully vested after one year from the date of
grant.
Also during the three months ended June 30,
2006, the Company modified 100,000 stock options previously granted to the
former CFO of the Company during 2005, such that the options will expire five
years from the date of grant, as opposed to 90 days after termination. In
connection with this modification, the Company recorded a charge of $0.1 million
to selling, general and administrative expenses in the consolidated statement
of operations for the three and six months ended June 30, 2006.
32
During the three months ended September 30,
2007, the Company issued, under the 2001 Stock Plan, (1) a total of
102,500 options to four employees with an exercise price of $3.38 per share,
which have a five year maximum contractual life and which vest annually over a
three year period from the date of grant and (2) a total of 50,000
performance-based options to one employee with an exercise price of $3.38 per
share and which have a maximum contractual life of five years. With respect to
these 50,000 performance-based stock options, no compensation expense will be recorded
until the performance-based vesting event is probable of occurrence. The grant
date fair value of this award was less than $0.1 million. During the three
months ended September 30, 2006, the Company issued, under the 2001 Stock
Plan, (1) a total of 105,000 options to three employees to purchase its
common stock at exercise prices ranging from $3.70 to $3.79 per share, which
have a five year maximum contractual life and which vest annually over a three
year period from the date of grant, and (2) a total of 75,000 options to
four independent Board of Director members to purchase its common stock at an
exercise price of $3.76 per share and which have a ten year maximum contractual
life. The Director options vest quarterly over one year beginning November 30,
2006.
2003
Stock Option and Stock Appreciation Rights Plan
On January 29,
2003, the Companys 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
Companys common stock to be awarded through incentive and non-qualified stock
options and stock appreciation rights. The 2003 Stock Plan is administered by
the Compensation Committee of the Companys 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 September 30,
2007, there were 2,125,000 options outstanding under the 2003 Stock Plan and 125,000
shares were available for issuance under the 2003 Stock Plan. No options were
granted under the 2003 Stock Plan during the three months and nine months ended
September 30, 2007 or September 30, 2006.
2005
Equity Incentive Plan
On April 26,
2005, the Companys 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 Companys 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 Companys 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 September 30,
2007, there were 305,000 options outstanding and 1,712,652 shares were
available for issuance under the 2005 Stock Plan. No stock options were issued
under the 2005 Stock Plan during both the three and nine months ended September 30,
2007.
During the three months ended June 30, 2006, the
Company issued 400,000 options to purchase its common stock with an exercise
price of $1.88 per share to the Companys 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.
33
Restricted
Stock
During
the three months ended March 31, 2006, the Company issued 126,750 shares
of restricted stock awards to various employees under the 2005 Equity Incentive
Plan. The restricted common stock vested quarterly over three years, beginning
on March 31, 2006 and ending on December 31, 2008. On March 31,
2006, 10,557 shares of the 126,750 shares of restricted stock vested. During
the three months ended June 30, 2006, 2,752 shares of the restricted stock
were cancelled due to terminations, 94,648 shares of restricted stock were
cancelled in a Board approved exchange for 206,500 stock options (which were
issued under the 2001 Plan) and 3,707 shares of restricted stock vested.
During the three and nine months ended September 30,
2007, respectively, 42 shares and 126 shares of restricted stock vested. As of September 30,
2007, 208 shares of unvested restricted stock were outstanding, which vest
quarterly through March 31, 2009.
Other
Stock Options
During both the three and nine months ended
September 30, 2007, the Company did not issue
any options outside the 2001 Stock Plan, the 2003 Stock Plan or the 2005 Stock
Plan. During the three months ended March 31,
2006, the Company did not issue any options outside the 2001 Stock Plan,
the 2003 Stock Plan or the 2005 Stock Plan.
During the three months ended June 30, 2006
,
the Company issued (1) 2,000,000
options to purchase its common stock with an exercise price of $1.88 per share
to the Companys CEO, which have a ten year maximum contractual life and which
vest each fiscal quarter end over a three year period from the date of grant, (2) 325,000 options to purchase its common stock with
an exercise price of $1.87 per share to the Companys CFO, which have a five
year maximum contractual life and vest annually over a three year period from
the date of grant and (3) 200,000 options to purchase its common stock with an exercise price of $1.87
per share to a separate employee, which have a five year maximum contractual
life and vest annually over a three year period from the date of grant.
In addition, during the three months ended June 30,
2006 the
Company issued 500,000 options to purchase its common stock
with an exercise price of $1.88 per share to the Companys CEO. These options
have a ten year maximum contractual life and the options have identical vesting
terms to the Performance Stock Option Grant issued under the 2005 Stock Plan
discussed above. No compensation cost has been recorded for this grant as the
Company does not currently believe that the vesting events are probable of
occurrence. The grant date fair value of the award was approximately $0.7
million. This fair value of $0.7 million, or any portion thereof, will not be
recognized as compensation expense until the vesting of the award becomes
probable.
As of September 30,
2007, there were 3,568,333 nonqualified stock options outstanding outside of
the shareholder approved plans discussed above.
Modification
of Stock Options
In connection
with the separation of the Companys President (see Note 7), the Company agreed
on March 16, 2007 to modify certain of the Presidents 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 during the months ended March 31, 2007.
One other employee stock option modification resulted in less than $0.1 million
charge to selling, general and administrative expense during the three months
ended March 31, 2007. No stock option modifications occurred during the
either the three months ended June 30, 2007 or three months ended September 30,
2007.
34
As discussed previously under 2001 Stock Option and
Stock Appreciation Rights Plan, during the three months ended June 30,
2006, the Company modified 100,000 stock options previously granted to the
former CFO of the Company during 2005, such that the options will expire five
years from the date of grant, as opposed to 90 days after termination. In
connection with this modification, the Company recorded a charge of $0.1
million to selling, general and administrative expenses in the consolidated
statement of operations for the three and six months ended June 30, 2006.
Equity
Instruments Issued for Services
As of September 30,
2007, the Company had outstanding 603,600 warrants and options issued to
non-employees under consulting agreements. The following sets forth certain
information concerning these warrants and options:
|
|
Vested
|
|
Warrants and options outstanding
|
|
603,600
|
|
Range of exercise prices
|
|
$1.50-6.00
|
|
Weighted average exercise price
|
|
$4.17
|
|
Expiration dates
|
|
2009-2013
|
|
Expense
related to these contracts was zero for the three months ended September 30,
2007 and less than $0.1 million for the three months ended September 30,
2006. Expense related to these contracts was less than $0.1 million for the
nine months ended September 30, 2007 and was $0.2 million for the nine
months ended September 30, 2006. The expense was calculated using the
Black Scholes option-pricing model based on the following weighted average
assumptions for the nine months ended September 30, 2007:
Expected life (years)
|
|
4-5 Years
|
|
Interest rate
|
|
4.0-4.97%
|
|
Dividend yield
|
|
|
|
Volatility
|
|
71-83%
|
|
Further,
there were 168,246 and 688,256 warrants outstanding as of September 30,
2007 and as of December 31, 2006, which were primarily issued in
connection with past equity offerings. There were no warrants converted or
forfeited during the three and nine months ended September 30, 2006.
During
the three and nine months ended September 30, 2007, there were 520,010
warrants exercised. 463,370 of these warrants were exercised via cash payment
of the $1.93 exercise price, and the remaining 56,640 warrants were exercised
via net share exercise. In total, 492,613 shares of common stock were issued as
a result of these warrants exercised and $0.9 million of cash proceeds were
received by the Company in connection with the payment of the related warrant
exercise price. The intrinsic value of the warrants exercised during the three
and nine months ended September 30, 2007 was $1.1 million.
Note 9Segment
Information and Geographical information
Since
the acquisition of Agera on August 10, 2006 (see Note 5), the Company has
operated 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 of autologous cellular therapies
for soft tissue regeneration. The Agera segment maintains proprietary rights to
a scientifically-based advanced line of skincare products. The operations of
the Agera segment were not material to the three months ended September 30,
2006. The following table provides operating financial information for the
Companys two reportable segments:
35
|
|
Segment
|
|
|
|
(in millions)
|
|
Isolagen
Therapy
|
|
Agera
|
|
Consolidated
|
|
Three months ended September 30, 2007
|
|
|
|
|
|
|
|
External revenue
|
|
$
|
|
|
$
|
0.3
|
|
$
|
0.3
|
|
Intersegment revenue
|
|
|
|
|
|
|
|
Total operating revenue
|
|
|
|
0.3
|
|
0.3
|
|
Cost of revenue
|
|
|
|
0.1
|
|
0.1
|
|
Selling, general and administrative expense
|
|
3.7
|
|
0.3
|
|
4.0
|
|
Research and development expense
|
|
3.1
|
|
|
|
3.1
|
|
Management fee
|
|
(0.2
|
)
|
0.2
|
|
|
|
Total operating expenses
|
|
6.6
|
|
0.5
|
|
7.1
|
|
Operating loss
|
|
(6.6
|
)
|
(0.3
|
)
|
(6.9
|
)
|
Interest income and other
|
|
0.2
|
|
|
|
0.2
|
|
Interest expense
|
|
(1.0
|
)
|
|
|
(1.0
|
)
|
Minority interest
|
|
|
|
|
|
|
|
Segment loss from continuing operations
|
|
$
|
(7.4
|
)
|
$
|
(0.3
|
)
|
$
|
(7.7
|
)
|
|
|
|
|
|
|
|
|
Nine months ended September 30, 2007
|
|
|
|
|
|
|
|
External revenue
|
|
$
|
|
|
$
|
1.0
|
|
1.0
|
|
Intersegment revenue
|
|
|
|
|
|
|
|
Total operating revenue
|
|
|
|
1.0
|
|
1.0
|
|
Cost of revenue
|
|
|
|
0.5
|
|
0.5
|
|
Selling, general and administrative expense
|
|
14.9
|
|
1.1
|
|
16.0
|
|
Research and development expense
|
|
9.6
|
|
|
|
9.6
|
|
Management fee
|
|
(0.5
|
)
|
0.5
|
|
|
|
Total operating expenses
|
|
24.0
|
|
1.6
|
|
25.6
|
|
Operating loss
|
|
(24.0
|
)
|
(1.1
|
)
|
(25.1
|
)
|
Interest income and other
|
|
0.8
|
|
|
|
0.8
|
|
Interest expense
|
|
(2.9
|
)
|
|
|
(2.9
|
)
|
Minority interest
|
|
|
|
0.3
|
|
0.3
|
|
Segment loss from continuing operations
|
|
$
|
(26.1
|
)
|
$
|
(0.8
|
)
|
$
|
(26.9
|
)
|
36
Supplemental
information:
for the three months ended September 30, 2007:
|
|
Segment
|
|
|
|
|
|
Isolagen
Therapy
|
|
Agera
|
|
Consolidated
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense
|
|
0.3
|
|
0.1
|
|
0.4
|
|
Capital expenditures
|
|
|
|
|
|
|
|
Equity awards issued for services
|
|
0.5
|
|
|
|
0.5
|
|
Amortization of debt issuance costs
|
|
0.2
|
|
|
|
0.2
|
|
Total assets (1)
|
|
29.9
|
|
5.4
|
|
35.3
|
|
Property and equipment, net
|
|
3.6
|
|
|
|
3.6
|
|
Intangible assets, net
|
|
0.5
|
|
4.2
|
|
4.7
|
|
Supplemental information:
for the nine months ended September 30, 2007:
|
|
Segment
|
|
|
|
(in millions)
|
|
Isolagen
Therapy
|
|
Agera
|
|
Consolidated
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense
|
|
0.9
|
|
0.2
|
|
1.1
|
|
Capital expenditures
|
|
0.1
|
|
|
|
0.1
|
|
Equity awards issued for services and equity award
modifications
|
|
2.6
|
|
|
|
2.6
|
|
Amortization of debt issuance costs
|
|
0.6
|
|
|
|
0.6
|
|
(1)
Total
assets on the consolidated balance sheet at September 30, 2007 are
approximately $46.4 million, which includes assets of continuing operations of
$35.3 million and assets of discontinued operations of $11.1 million. An
intercompany receivable of $1.0 million, due from the Agera segment to the
Isolagen Therapy segment, 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.
Geographical information
concerning the Companys operations and assets is as follows:
|
|
Revenue
Three months ended September 30,
|
|
(in millions)
|
|
2007
|
|
2006
|
|
United States
|
|
$
|
0.1
|
|
$
|
|
|
United Kingdom
|
|
0.2
|
|
0.1
|
|
Other
|
|
|
|
|
|
|
|
$
|
0.3
|
|
$
|
0.1
|
|
|
|
Revenue
Nine months ended September 30,
|
|
|
|
2007
|
|
2006
|
|
United States
|
|
$
|
0.3
|
|
$
|
|
|
United Kingdom
|
|
0.7
|
|
0.1
|
|
Other
|
|
|
|
|
|
|
|
1.0
|
|
$
|
0.1
|
|
|
|
|
|
|
|
|
|
37
|
|
Property and Equipment, net
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
2007
|
|
2006
|
|
United States
|
|
$
|
3.6
|
|
$
|
4.3
|
|
|
|
$
|
3.6
|
|
$
|
4.3
|
|
|
|
Intangible Assets, net
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
2007
|
|
2006
|
|
United States
|
|
$
|
4.7
|
|
$
|
4.9
|
|
|
|
$
|
4.7
|
|
$
|
4.9
|
|
38
ITEM 2.
MANAGEMENTS 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
managements 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 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;
our ability to finance our business;
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;
a stable currency rate environment in
the world, and specifically the countries we are doing business in or plan to
do business in;
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;
continued availability of supplies at
satisfactory prices;
new entrance of competitive products
or further penetration of existing products in our markets;
the effect on us from adverse
publicity related to our products or the Company itself;
any adverse claims relating to our
intellectual property;
the adoption of new, or changes in,
accounting principles;
adverse results from, or changes in,
any pending legal proceedings;
39
our ability to maintain compliance
with the AMEX requirements for continued listing of our common stock;
the costs inherent with complying
with statutes and regulations applicable to public reporting companies, such as
the Sarbanes-Oxley Act of 2002;
our ability to efficiently integrate
our recent 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 closing of our UK operation;
whether current 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, 2006, as well as Part II, Item 1A of
our Form 10-Q for the three and six months ended June 30, 2007.
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 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
burns with a patients own, or autologous, fibroblast cells produced in our
proprietary Isolagen Process. Our clinical development programs encompass both
aesthetic and therapeutic indications. Our most advanced indication utilizing
the Isolagen Process is for the treatment of wrinkles and is currently in Phase
III clinical development. We are in the process of initiating a Phase III study
in acne scars. We also have ongoing Phase II trials in full face rejuvenation
and periodontal disease and plan to initiate an additional Phase II trial for
burn scars. 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.
We have adopted an
eight-point business strategy created by the new management team put in place
in June 2006. The objectives of this business strategy are to achieve
regulatory milestones, position the company and its products properly, create a
commercial operations infrastructure, and exploit complementary business
opportunities by:
Targeting
areas of skin and tissue rejuvenation with compelling market potential.
Advancing
existing clinical development programs and identifying other strategic
indications.
Developing
manufacturing efficiencies and effective process improvements.
Pursuing
opportunities to in-license or purchase complementary products and/or
technologies.
Acquiring
small businesses or creating co-marketing arrangements aligned with our overall
business strategy.
Optimizing
the value of our intellectual property and business relationships through
partnerships to exploit synergies.
Focusing
our management resources on building our business from the United States
outward, intending ultimately to move into or operate in foreign markets where
business opportunities then exist.
Adding
proven and experienced biotechnology and health care professionals to our
management team.
40
We
sometimes refer to our product candidates in the aggregate as Isolagen Therapy.
From 2002 through 2006, we made Isolagen Therapy available to physicians
primarily in the United Kingdom. In the fourth quarter of 2006, our Board of
Directors approved closing our United Kingdom operation. Our United Kingdom
operation was shutdown on March 31, 2007 (as more fully discussed in Note
4 in Notes to the Consolidated Financial Statements and below). We have
refocused our management and capital resources on building our business in the
United States. As our operations mature in the United States we expect to enter
foreign markets when business opportunities that are consistent with our
business strategy present themselves.
We market and sell an advanced skin care line
through our majority-owned subsidiary, Agera, 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
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).
We are
considered to be a development stage enterprise.
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 (1) to treat targeted
areas or wrinkles, and (2) 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 restrictive burn scars,
acne 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 complete is subject to a number of factors and
uncertainties.
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 agencys Special Protocol Assessment, or SPA. Pursuant to this
assessment process, the FDA has agreed that our study design for two identical
trials, including patient 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. As we have
previously disclosed, we encountered certain delays related to manufacturing
and scheduling in connection with the study. We conferred with the FDA
regarding these issues, and based on our findings and our dialogue with the
FDA, we submitted an amendment to our study protocol and chemistry,
manufacturing and control (CMC) submission. On June 1, 2007, we received
approval of the amendment and the related Informed Consent Forms from the
Investigational Review Board. On July 11, 2007, the FDA notified us that
our proposed changes to the protocol were acceptable and within the scope of
the original SPA review. We expect that injections related to this study will
be completed during January 2008.
Refer
to Part II, Item 1A of this Form 10-Q for an update of our risk
factor 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.
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. All 45 remaining subjects have
been enrolled and biopsied. Five investigators across the United States are
participating in this trial. The subjects will receive two series of
injections approximately one month apart. The
41
subjects will be followed for six months following
each subjects last injection. We expect to complete all injections by the end
of 2007.
Therapeutic
Development Programs
Acne Scars -
Phase III Trials:
We are preparing for an acne scar Phase III trial program. This program will
encompass two identical Phase III trials with approximately 120 patients in
each trial. These placebo controlled trials are 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 subjects last injection.
In connection with this acne scar
program, we have recently developed a validated photo guide for use in the
evaluators' assessment of acne study subjects. Our evaluator assessment scale
and photo guide have never been utilized in a phase III trial.
A pre- Investigational
New Drug application, or pre-IND, meeting with the FDA was held on March 2,
2007 to discuss our trial design to study the Isolagen Therapy for the
treatment of acne scarring. Based on our discussion with the FDA, we filed an
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 have
scheduled the investigator meeting for early November 2007 and expect to
commence the clinical program shortly thereafter.
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. We filed an IND for Isolagen Therapy to treat restrictive
burn scars in February 2007. Based on our discussions with the FDA, we are
preparing to initiate a Phase II trial to evaluate the use of Isolagen Therapy
to improve range of motion, function and flexibility, among other parameters,
in existing restrictive burn scars. We plan to commence this demonstration
trial, of approximately 20 patients, during the fourth quarter of 2007.
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 and the trial is expected to be completed and the data evaluated
during the first half of 2008. We are identifying a development strategy for
this application.
Closure
of the United Kingdom Operation
As part of
our continuing efforts to evaluate the best uses of our resources, in the
fourth quarter of 2006 our Board of Directors approved the proposed closing of
the United Kingdom operation. After a full business analysis, management and
the Board determined that the best use of resources was to focus on our
strategic opportunities. As such, our first priority is to advance the United
States pivotal Phase III clinical trial for the use of Isolagen Therapy for the
treatment of certain facial wrinkles, and then, with regulatory agencies
agreement, initiate clinical studies in other therapeutic and aesthetic areas.
On March 31, 2007, we completed the closure of
the 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 are under operating leases. The manufacturing
site lease expires February 2010 and, as of September 30, 2007, the
remaining lease obligation approximated $0.5 million. The administrative site
lease expired in April 2007.
Excluding the manufacturing lease, which ends February 2010
unless terminated sooner, i
t is expected that the majority of all
remaining costs to be incurred will be recorded during 2007. However, no
assurances can be given with respect to the total cost of closing the United
Kingdom operation or the timing of such costs. The Company believes that the
amount of all future charges associated with the United Kingdom operation
shutdown,
42
such as potential lease
exit costs and professional fees, among other items, cannot be precisely
estimated at this time. However, as of September 30, 2007, remaining
future charges are expected to be approximately $0.6 million (both before
and after tax), including $0.5 million of remaining lease obligations, but
excluding potential claims or contingencies unknown at this time.
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 4 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.
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. This change in
43
accounting
resulted in the recognition of compensation expense of $0.5 million and $0.4
million for three months ended September 30, 2007 and 2006, respectively,
and $1.4 million and $0.8 million for the nine months ended September 30,
2007 and 2006, respectively, related to our employee and director stock
options. During the three months ended September 30, 2007, we granted
stock options to purchase 0.2 million shares of our common stock. As of September 30,
2007, there was $2.6 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 1.9 years. As of
September 30, 2007, there was $1.1 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.
In March 2007,
and in connection with the separation of the Companys President, the Company
agreed to modify certain of the Presidents 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 will 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 during
the months ended March 31, 2007. One other employee stock option
modification resulted in less than $0.1 million charge to selling, general and
administrative expense during the three months ended March 31, 2007.
Federal Securities and Derivative Actions:
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.
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 matters, management believes that the results will not have a
material impact on our financial statements.
44
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.
Going
Concern
As of September 30,
2007, we had cash, cash equivalents and restricted cash of $24.1 million and
working capital of $19.9 million (including our cash, cash equivalents and
restricted cash). We believe our existing capital resources are adequate to
finance our operations through June 30, 2008; however, our long-term
viability is dependent upon successful operation of our business, our ability
to improve our manufacturing process, the approval of our products and the
ability to raise additional debt and/or equity to meet our business objectives.
We estimate that we will require additional cash resources during the third
quarter of 2008 based upon our current operating plan and condition. This
estimate excludes any proceeds that would be realized from the sale of our
Swiss corporate campus (discussed further below).
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 September 30,
2007 we can offer and sell up to an additional $36.2 million of common stock
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 markets
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 SECs regulatory calendar, as well as our ability to
timely respond to any SEC comments that have been or will be issued. We are
also continuing our efforts to sell our Swiss corporate campus. We will add any
proceeds from the sale of the Swiss corporate campus to our working capital,
which would partially alleviate our need to obtain financing from other
sources. 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 above discussed conditions, 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 third 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.
Results
of Operations
Comparison of the
three months ended September 30, 2007 and 2006
REVENUES.
Revenue increased $0.2 million to $0.3 million for the three months ended September 30,
2007, as compared to $0.1 million for the three months ended September 30,
2006. Our revenue from continuing operations is from the operations of Agera
which we acquired on August 10, 2006. Agera markets and sells a
45
complete line of advanced
skin care systems based on a wide array of proprietary formulations, trademarks
and non-peptide technology. On a pro forma basis, assuming that Agera had been
acquired on January 1, 2006, our revenue would have been $0.3 million for
the quarter ended September 30, 2006. Due to our financial statement
presentation of our United Kingdom operation as a discontinued operation, our
revenue for the three months ended September 30, 2006 is representative of
only Agera, as all historical United Kingdom revenue is reflected in loss from
discontinued operations.
COST
OF SALES. Costs of sales increased to $0.2 million for the three months ended September 30,
2007, as compared to $0.1 million for the three months ended September 30,
2006. Our cost of sales relates to the operation of Agera.
As a
percentage of revenue, Agera cost of sales were approximately 48% for the three
months ended September 30, 2007. On a pro forma basis, assuming Agera had
been acquired on January 1, 2006, our cost of sales as a percentage of
revenue would have been 50%.
SELLING,
GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses
increased approximately $1.3 million, or 48%, to $4.0 million for the
three months ended September 30, 2007, as compared to $2.7 million
for the three months ended September 30, 2006. The increase in selling,
general and administrative expense is primarily due to the following:
a) Corporate expense increased
$1.0 million to $1.2 million for the three months ended September 30,
2007, as compared to $0.2 million for the three months September 30, 2006
due to the following non-recurring costs incurred during the current quarter:
$0.8 million of expense related to our debt exchange offer (such as legal,
accounting and printer costs), which we withdrew and terminated during the
three months ended September 30, 2007 (see further discussion in Unaudited
Notes to the Consolidated Financial Statements, Footnote 3, Debt Issue Costs);
and less than $0.2 million related to business development activities.
b) Legal expenses
increased by approximately $0.4 million to $0.4 million for the three months
ended September 30, 2007. During the three months ended September 30,
2006, we received a reimbursement of $0.7 million from our insurance carrier
for reimbursement of defense cost related to the class action and
derivative action matters. If we had not received this $0.7 million
reimbursement, our legal expenses would have been approximately $0.6 million
for the three months ended September 30, 2006. During the three months
ended September 30, 2007, we received a reimbursement of less than $0.1
million from our insurance carrier for reimbursement of defense cost related to
the class action and derivative action matters. If we had not received
this reimbursement, our legal expenses would have been approximately $0.5
million for the three months ended September 30, 2007. In general, our
legal expense, net, fluctuates primarily as a result of the level of class action
and derivative action defense costs incurred during a particular period and as
a result of the timing of related insurance carrier reimbursements for defense
costs. Such reimbursements are recorded when received.
c)
Compensation expense decreased $0.2
million to $1.1 million for the three months ended September 30,
2007, as compared to $1.3 million for the three months ended September 30,
2006 primarily due to lower bonus expense earned, as well as to compensation
expense savings related to the departure of our former President, who was not
replaced.
RESEARCH
AND DEVELOPMENT.
Research and
development expenses increased by approximately $1.2 million for the three
months ended September 30, 2007 to $3.1 million, as compared to
$1.8 million for the three months ended September 30, 2006. 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.
Our
initial pivotal Phase III wrinkle/nasolabial fold trial and our
Phase II dental trial concluded during the first half of 2005. We
subsequently commenced preparations for a Phase III wrinkle/nasolabial
fold trial during the fourth quarter of 2005. In October 2006, we reached
an agreement with the FDA on the design of our Phase III wrinkle/nasolabial
fold study protocol. The protocol was submitted to the FDA under the agencys
Special Protocol
46
Assessment (SPA)
regulations. We completed enrollment of our Phase III wrinkle/nasolabial fold
study and commenced injections in early 2007. Research and development costs
primarily include personnel and laboratory costs related to these FDA trials
and certain consulting costs. The total inception to date cost of research and
development as of September 30, 2007 was $40.2 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 previously
conducted Phase III wrinkle/nasolabial fold 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, or any other product candidate.
We have other research projects currently underway. However, research and
development costs related to these other projects were not material during the
three months ended September 30, 2007 and 2006.
The
major changes in research and development expense are due primarily to the
following:
a)
Consulting
expense increased by approximately $0.7 million to $1.4 million for
the three months ended September 30, 2007, as compared to
$0.7 million for the three months ended September 30, 2006, as a
result of increased expenditures related to our current wrinkle/nasolabial fold
study and preparations related to other clinical trials;
b)
Salaries,
bonuses and payroll taxes increased by approximately $0.2 million to $0.8
million for the three months ended September 30, 2007, as compared to $0.6
million for the three months ended September 30, 2006, as a result of
increased employees engaged in research and development activities;
c)
Laboratory
costs increased by approximately $0.1 million to $0.3 million for the three
months ended September 30, 2007, as compared to $0.2 million for the three
months ended September 30, 2006, as a result of increased clinical
activities in our Exton, Pennsylvania location; and
d)
Contract
labor support related to our clinical manufacturing operation increased to $0.2
million for the three months ended September 30, 2007, as compared to zero
for the three months ended September 30, 2006, as a result of increased
clinical activities in our Exton, Pennsylvania location.
e)
Facilities,
depreciation and travel costs remained unchanged for the three months ended September 30,
2007, as compared to the three months ended September 30, 2006, at $0.4
million.
LOSS
FROM DISCONTINUED OPERATIONS. Loss from discontinued operations decreased by
approximately $1.7 million for the three months ended September 30, 2007
to $0.1 million, as compared to $1.8 million for the three months ended September 30,
2006. As previously discussed 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. On March 31, 2007,
the United Kingdom operation was closed. As such, during the three months ended
September 30, 2007, costs related to the United Kingdom operation
decreased to $0.1million, which primarily consisted of facility expense, legal
expense and public relations costs, as compared to normal, pre-close operations
during the three months ended September 30, 2006.
INTEREST
INCOME. Interest income decreased approximately $0.4 million to $0.2 million
for the three months ended September 30, 2007, as compared to
$0.6 million for the three months ended September 30, 2006. The
decrease in interest income of $0.4 million resulted principally from a
decrease in the amount of cash, restricted cash and short-term investment
balances, as a result of our use of these balances to fund our normal operating
activities primarily related to our efforts to gain FDA approval for our
Isolagen Therapy.
INTEREST
EXPENSE. Interest expense remained
constant at $1.0 million for the three months ended September 30, 2007, as
compared to the three months ended September 30, 2006. 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 September 30, 2007 and 2006,
respectively.
47
NET
LOSS. Net loss increased $1.1 million to
$7.8 million for the three months ended September 30, 2007, as compared to
a net loss of $6.7 million for the three months ended September 30,
2006. This increase in net loss primarily represents the effects of the
increases in our selling, general and administrative expenses and research and
development expenses, offset by our decrease in loss from discontinued
operation, as discussed above.
Comparison of the
nine months ended September 30, 2007 and 2006
REVENUES.
Revenue increased $0.9 million to $1.0 million for the nine months ended September 30,
2007, as compared to $0.1 million for the nine months ended September 30,
2006. Our revenue from continuing operations is from the operations of Agera
which we acquired on August 10, 2006. On a pro forma basis, assuming that
Agera had been acquired on January 1, 2006, our revenue would have been
$0.9 million for the nine months ended September 30, 2006. Due to our
financial statement presentation of our United Kingdom operation as a
discontinued operation, our revenue for the nine months ended September 30,
2007 and 2006 is representative of only Agera, as all historical United Kingdom
revenue is reflected in loss from discontinued operations.
COST
OF SALES. Costs of sales increased to $0.4 million to $0.5 million for the nine
months ended September 30, 2007, as compared to $0.1 million for the nine
months ended September 30, 2006. Our cost of sales relates to the
operation of Agera.
As a
percentage of revenue, Agera cost of sales were approximately 48% for the nine
months ended September 30, 2007. On a pro forma basis, assuming Agera had
been acquired on January 1, 2006, our cost of sales would have been $0.5
million, or 49% as a percentage of revenue, for the nine months ended September 30,
2006.
SELLING,
GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative
expenses increased approximately $7.3 million, or 83%, to $16.1 million
for the nine months ended September 30, 2007, as compared to
$8.8 million for the nine months ended September 30, 2006. This
increase included $1.1 million of selling, general and administrative expenses
related to Agera (which was acquired in August 2006) for the nine months
ended September 30, 2007, as compared to $0.6 million of selling, general
and administrative expenses related to Agera for the nine months ended September 30,
2006. Including Agera, the increase in selling, general and administrative
expense is primarily due to the following:
a) Additional severance
expense associated with the termination of our President, and the related
settlement agreement executed in June 2007, resulted in an additional $3.2
million of selling, general and administrative expense for the nine months
ended September 30, 2007 (
see Notes 7 and 8 of Notes to Consolidated Financial Statements).
b) Salaries, bonuses and payroll
taxes increased by approximately $1.9 million to $5.3 million for the nine
months ended September 30, 2007, as compared to $3.4 million for the nine
months ended September 30, 2006, due to an increase in the number of our
employees, primarily at the executive management level, which resulted in
higher salary and bonus expenses.
c) Marketing expense increased
by approximately $0.5 million to $0.8 million for the nine months ended September 30,
2007, as compared to $0.3 million during the nine months ended September 30,
2006 due primarily to marketing and promotional efforts related to marketing
and selling our Agera line of advanced skin care systems.
d) Travel expense increased by
approximately $0.2 million to $0.6 million for the nine months ended September 30,
as compared to $0.4 million for the nine months ended September 30, 2006
due to the increase in the number of our employees, primarily at the executive
management level, and increase in business development activities.
e) Other general and
administrative operating costs increased by approximately $1.9 million to $5.5
million for the nine months ended September 30, 2007, as compared to $3.6
million for the nine months ended September 30, 2006 due primarily to
costs of approximately $0.8 million related to our withdrawn and terminated
debt offering, increased business development activities and increased investor
relations costs for the nine months ended September 30, 2007, as well as
the addition of general expenses related to our August
48
2006
acquisition of Agera. We incurred non-cash amortization expense related to our
Agera intangible assets of approximately $0.2 million for the nine months ended
September 30, 2007.
f) Legal expenses
decreased by approximately $0.4 million to $0.6 million for the nine months
ended September 30, 2007, as compared to $1.0 million for the nine months
ended September 30, 2006. For the nine months ended September 30,
2007 and September 30, 2006, we received $1.6 million and $0.7 million,
respectively, of reimbursements from our insurance carrier as reimbursement for
defense costs related to our class action and derivative matters. If we
had not received these reimbursements, our legal expenses would have been $2.2
million for the nine months ended September 30, 2007 and $1.8 million for
the nine months ended September 30, 2006. Excluding the insurance carrier
reimbursement, legal expenses increased $0.4 million for the nine months ended September 30,
2007, as compared to nine months ended September 30, 2006, primarily due
to $0.3 million of increased legal costs related to the termination of our
President. In general, our legal expense, net, fluctuates primarily as a result
of the level of class action and derivative action defense costs incurred
during a particular period and as a result of the timing of related insurance
carrier reimbursements for defense costs. Such reimbursements are recorded when
received.
RESEARCH
AND DEVELOPMENT. Research and
development expenses increased by approximately $3.1 million for the nine
months ended September 30, 2007 to $9.6 million, as compared to
$6.4 million for the nine months ended September 30, 2006. 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.
Our
initial pivotal Phase III wrinkle/nasolabial fold trial and our
Phase II dental trial concluded during the first half of 2005. We
subsequently commenced preparations for a Phase III wrinkle/nasolabial
fold trial during the fourth quarter of 2005. In October 2006, we reached
an agreement with the FDA on the design of our Phase III wrinkle/nasolabial
fold study protocol. The protocol was submitted to the FDA under the agencys
Special Protocol Assessment (SPA) regulations. We completed enrollment of our
Phase III wrinkle/nasolabial fold study and commenced injections in early 2007.
Research and development costs primarily include personnel and laboratory costs
related to these FDA trials and certain consulting costs. The total inception
to date cost of research and development as of September 30, 2007 was
$40.2 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 previously conducted Phase III wrinkle/nasolabial fold
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 other projects were not material during the
nine months ended September 30, 2007 and 2006.
The
major changes in research and development expenses are due primarily to the
following:
a)
Consulting
expense increased by approximately $2.0 million to $4.5 million for
the nine months ended September 30, 2007, as compared to $2.5 million
for the nine months ended September 30, 2006, as a result of increased
expenditures related to our current wrinkle/nasolabial fold study and
preparations related to other clinical trials;
b)
Salaries,
bonuses and payroll taxes increased by approximately $0.5 million to $2.4
million for the nine months ended September 30, 2007, as compared to $1.9
million for the nine months ended September 30, 2006, as a result of
increased employees engaged in research and development activities; and
c)
Laboratory
costs increased by approximately $0.5 million to $1.1 million for the nine
months ended September 30, 2007, as compared to $0.6 million for the nine
months ended September 30, 2006, as a result of increased clinical
activities in our Exton, Pennsylvania location.
49
d)
Contract
labor support related to our clinical manufacturing operation increased $0.2
million to $0.3 million for the nine months ended September 30, 2007, as
compared to less than $0.1 million for the nine months ended September 30,
2006, as a result of increased clinical activities in our Exton, Pennsylvania
location.
e)
Facilities,
depreciation and travel costs decreased $0.2 million to $1.3 million for the
nine months ended September 30, 2007, as compared to $1.5 million for the
nine months ended September 30, 2006.
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, as compared to normal
operations during the nine months ended September 30, 2006.
The
loss from discontinued operations decreased by approximately $7.0 million for
the nine months ended September 30, 2007 to $1.5 million, as compared to
$8.5 million for the nine months ended September 30, 2006. The $1.5
million loss from discontinued operations during the nine months ended September 30,
2007 consisted of $1.1 million of losses incurred during the first quarter
2007, which was the United Kingdoms last quarter of full operations, and $0.4
million of second and third quarter 2007 losses (which, after closure of the
operation, primarily consisted of facility expense, legal expense and public
relations costs). 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 $1.1 million to
$0.7 million for the nine months ended September 30, 2007, as
compared to $1.8 million for the nine months ended September 30,
2006. The decrease in interest income of $1.1 million resulted principally
from a decrease in the amount of cash, restricted cash and short-term
investment balances, as a result of our use of these balances to fund our
normal operating activities primarily related to our efforts to gain FDA
approval for our Isolagen Therapy.
INTEREST
EXPENSE. Interest expense remained
constant at $2.9 million for the nine months ended September 30, 2007, as
compared to the nine months ended September 30, 2006. 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
$0.6 million for each of the nine months ended September 30, 2007 and
2006, respectively.
NET
LOSS. Net loss increased $3.8 million to
$28.5 million for the nine months ended September 30, 2007, as compared to
a net loss of $24.7 million for the nine months ended September 30,
2006. This increase in net loss primarily represents the effects of the
increases in our selling, general and administrative expenses and research and
development expenses, reductions in interest income, offset by our decrease in
loss from discontinued operation and additional gross profit of $0.4 million,
as discussed above.
LIQUIDITY
AND CAPITAL RESOURCES
Net
cash provided by (used in) operating, investing and financing activities for
the nine months ended September 30, 2007 and 2006, respectively, were as
follows:
|
|
Nine Months Ended September 30,
|
|
|
|
2007
|
|
2006
|
|
|
|
(in millions)
|
|
Cash flows from operating activities
|
|
$
|
(23.0
|
)
|
$
|
(20.7
|
)
|
Cash flows from investing activities
|
|
(0.1
|
)
|
20.0
|
|
Cash flows from financing activities
|
|
14.7
|
|
0.2
|
|
|
|
|
|
|
|
|
|
50
Operating
Activities
Cash
used in operating activities during the nine months ended September 30,
2007 amounted to $23.0 million, as compared to the $20.7 million of cash used
in operating activities during the nine months ended September 30, 2006.
The increase in the cash used in operations of $2.3 million is primarily due to
our increase in net loss, adjusted for noncash items, of $3.6 million. Our net
loss, adjusted for noncash items, increased from $20.8 million during the nine
months ended September 30, 2006 to $24.4 million during the nine months
ended September 30, 2007. This increase in net loss, adjusted for noncash
items, was offset by changes in net operating assets and liabilities, which
positively impacted cash flows by $1.3 million. During the nine months ended September 30,
2007, our changes in net operating assets and liabilities resulted in a cash
inflow of $1.4 million, as compared to a cash inflow of $0.1 million during the
nine months ended September 30, 2006. For the nine months ended September 30,
2007, 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 our August 2007
common stock sale (discussed below), which resulted in $13.8 million of
proceeds, net of offering costs.
Investing
Activities
Cash
used in investing activities during the nine months ended September 30,
2007 amounted to approximately $0.1 million as compared to cash provided in
investing activities of $20.0 million during the nine months ended September 30,
2006. Investing activities for the nine months ended September 30, 2007
related primarily to $0.1 million of capital expenditures. The cash inflows of
$20.0 million during the nine months ended September 30, 2006 were
provided by the sale of available-for-sale investments, net, of $23.0 million,
offset by the acquisition of Agera for $2.0 million, net, and capital
expenditures of $1.0 million.
Financing
Activities
Cash
proceeds from financing activities during the nine months ended September 30,
2007 amounted to $14.7 million, as compared to $0.2 million during the nine
months ended September 30, 2006. In August 2007, we raised $13.8
million, net of offering costs, via the sale of 6.8 million shares of our
common stock to institutional investors. In addition, during the nine months
ended September 30, 2007, we received cash proceeds of approximately $0.9
million as a result of stock option and warrant exercises. Cash proceeds from
financing activities were less than $0.2 million during the nine months ended September 30,
2006, which related to cash proceeds from stock option exercises.
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:
|
|
Nine Months Ended September 30,
|
|
|
|
2007
|
|
2006
|
|
|
|
(in millions)
|
|
Cash flows from operating activities
|
|
$
|
(2.4
|
)
|
$
|
(7.9
|
)
|
Cash flows from investing activities
|
|
|
|
(0.3
|
)
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows used in discontinued operations during the nine months ended September 30,
2007 was $2.4 million, of which substantially the entire cash outflow was
incurred during the three months ended March 31, 2007. Our United Kingdom
operation was in operation 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
51
revenue are what
primarily generated $2.1 million of cash outflow from discontinued operations
for the three months ended March 31, 2007. Cash outflows related to the
nine months ended September 30, 2006 related primarily to the normal,
historical operation of the United Kingdom and Swiss operations, prior to the
decision to shutdown the United Kingdom operation.
Working
Capital
As of September 30,
2007, we had cash, cash equivalents and restricted cash of $24.1 million and
working capital of $19.9 million (including our cash, cash equivalents and
restricted cash). We believe our existing capital resources are adequate to
finance our operations through June 30, 2008; however, our long-term
viability is dependent upon successful operation of our business, our ability
to improve our manufacturing process, the approval of our products and the
ability to raise additional debt and/or equity to meet our business objectives.
We estimate that we will require additional cash resources during the third
quarter of 2008 based upon our current operating plan and condition. This
estimate excludes any proceeds that would be realized from the sale of our
Swiss corporate campus (discussed further below). 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 September 30, 2007 we can
offer and sell up to an additional $36.2 million of common stock 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 markets
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 SECs regulatory calendar, as well as our
ability to timely respond to any SEC comments that have been or will be issued.
We are also continuing our efforts to sell our Swiss corporate campus. We will
add any proceeds from the sale of the Swiss corporate campus to our working
capital, which would partially alleviate our need to obtain financing from
other sources. 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 above discussed conditions, 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 third 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.
52
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
In April 2005,
we acquired land and a two-building, 100,000 square foot corporate campus in
Bevaix, Canton of Neuchâtel, Switzerland for $10 million. We spent
approximately $1.8 million to date on the first phase of the renovation. During
April 2006, management decided to place the corporate campus on the market
for sale in order to consolidate European operations into one location and to
conserve capital. We commenced selling efforts during the second quarter of
2006.
During
2006, management assessed whether the book value of the corporate campus was
impaired and made a determination to write down the corporate campus by $1.1
million, which is reflected in loss from discontinued operations in the
consolidated statement of operations. The net book value of the corporate
campus at September 30, 2007 was $11.0 million, reflecting managements
estimate of the realizable value of the corporate campus.
An adverse result related to our class action
matter, derivative action matter (see Note 7 in Notes to Consolidated Financial
Statements) could materially, adversely affect our working capital, thereby
materially impacting the financial position of the Company.
Inflation
did not have a significant impact on the Companys results during the three
months ended September 30, 2007.
Off-Balance
Sheet Transactions
We do
not engage in material off-balance sheet transactions.
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.
53
Foreign Exchange
Rate Risk
We
have $11.1 million in foreign assets. Our Swiss corporate campus held for sale,
with a currently estimated value of $11.0 million at September 30, 2007,
accounts for the large majority of these foreign assets. Our consolidated
shareholders deficit will fluctuate depending on the weakening or
strengthening of the U.S. dollar against the respective foreign currency,
especially the Swiss franc.
Our
accumulated other comprehensive income of $0.4 million at September 30,
2007 has varied $0.5 million from accumulated other comprehensive loss of $0.1
million at December 31, 2006. However, this $0.4 million gain is
considered unrealized and is reflected on the Consolidated Balance Sheet.
Accordingly, this unrealized loss may increase or decrease in the future,
based on the movement of foreign currency exchange rates, but will not have an
impact on net income (loss) until the related foreign capital investments are
sold or otherwise realized.
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. The Companys management, with the participation of
the Companys Chief Executive Officer, and the Companys Chief Financial
Officer (the Certifying Officers), has evaluated the effectiveness of the
Companys 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 the Companys
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 the Company in the reports that it files or submits under the
Exchange Act is accumulated and communicated to the Companys management,
including its 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 the Companys internal
control over financial reporting that occurred during the Companys most recent
fiscal quarter that has materially affected, or is reasonably likely to
materially affect, the Companys internal control over financial reporting.
PART II - OTHER INFORMATION
ITEM 1. LEGAL
PROCEEDINGS
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,
54
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.
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 our motions to dismiss the complaint, and the Company
expects the parties will commence discovery shortly.
The
Company intends to defend these lawsuits vigorously. However, 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.
The
Company has received requests for reimbursement of costs of defense of
approximately $0.3 million from Mr. Jeffrey Tomz, the Companys former
Chief Financial Officer, who is named as a defendant in the litigation
described above. The Company and Mr. Tomz have a dispute with respect to
the Companys indemnification obligations to Mr. Tomz. The Companys
view is that under its separation agreement with Mr. Tomz it owes Mr. Tomz
only those benefits required to be provided to a former officer under
Delaware law. Mr. Tomz view apparently is that the Company owes him
more than the minimum required by Delaware law and is obliged to advance his
costs of defense. In the event of a final adjudication of a matter in which Mr. Tomz
is a defendant, the Company will be obliged to reimburse Mr. Tomz for the
cost of defense, provided that he was successful, he acted in good faith in the
circumstances underlying the case, and that his legal expenses are reasonable
and are documented in a manner proscribed by the Delaware courts. As
previously disclosed, a final determination in favor of all of the defendants,
including Mr. Tomz, has been made in one of the derivative actions filed
against certain current and former officers and directors, the
Fordyce
case. In the event that Mr. Tomz
is able to satisfy the standards described above for reimbursement of his legal
defense costs incurred in connection with the
Fordyce
case, the Company will be obligated to pay them. To date the Company has
not reimbursed any of Mr. Tomz defense costs, and it has recorded no
charge in its consolidated statements of operation other than a reserve of
approximately $20,000 in connection with the
Fordyce
case.
55
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
Companys 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. Certain individual defendants are accused of
improper trading in Isolagen stock. 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.
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 plaintiffs 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 plaintiffs
motion to file a second amended complaint, and from the April 10, 2007
order dismissing plaintiffs amended complaint without prejudice. The parties
are currently briefing the plaintiffs appeal.
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.
56
The
Derivative Actions are purportedly being prosecuted on behalf of the Company
and any recovery obtained, less any attorneys fees awarded, will go to 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.
On October 17,
2007, a purported shareholder named Mr. Ronald Beattie sent a letter to
the Companys chairman and Chief Executive Officer demanding that the Company
take action against the former officers and directors named as defendants in the
derivative actions described above for purportedly wrongful acts materially
identical to those alleged in the derivative actions described above, and
declaring he will file a shareholder derivative action if the Company does not
commence an action on its own behalf within a reasonable time. The Company
has not yet responded to this letter.
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 matters, management currently believes that the
results will not have a material impact on the Companys financial statements.
ITEM 1A.
RISK FACTORS
In
addition to the Risk Factors disclosed in our June 30, 2007 Form 10-Q,
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.
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 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, as of November 1, 2007, has 191
remaining. Our 005 study enrolled 203 subjects and, as of November 1,
2007, has 168 remaining. The Company continues to focus its efforts to prevent
additional dropouts in both trials.
Recently, we made a
decision to remove certain subjects from the trial for whom adequate cell
yields could not be obtained within a certain timeframe. These dropouts
included subjects who were assigned to active and placebo treatment on
approximately a one-to-one ratio. In October 2007, we submitted a protocol
amendment to the FDA which, among other things, redefines the intent-to-treat
population to exclude subjects for whom adequate cell yields could not be
obtained for treatment. The FDA has 45 days to respond to our request for
protocol amendment.
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.
Clinical trials may fail to demonstrate the safety or
efficacy of our product candidates, which could prevent or significantly delay
regulatory approval and/or prevent us from raising additional financing.
Prior to receiving
approval to commercialize any of our product candidates, we must demonstrate
with substantial evidence from well-controlled clinical trials, and to the
satisfaction of the FDA and other regulatory authorities in the United States
and abroad, that our product candidates are both safe and
effective. We will need to demonstrate our product
candidates efficacy and monitor their safety throughout
the process. We
are conducting a pivotal Phase III clinical trial related to our lead facial
aesthetic product candidate. The success of prior
pre-clinical or clinical trials does not ensure the success of these trials,
which are being conducted in populations with different racial and ethnic
demographics than
our previous trials. If our current trials or any
future clinical trials are unsuccessful, our business and reputation would be
harmed and the price at which our stock trades could be adversely affected.
All of our product
candidates are subject to the risks of failure inherent in the development of
biotherapeutic products. The results of early-stage clinical trials of
our product candidates do not necessarily predict the results of later-stage
clinical trials. Product candidates in later-stage clinical trials may
fail to demonstrate desired safety and efficacy traits despite having
successfully progressed through initial clinical testing. Even if we believe
the data collected from clinical trials of our product candidates is promising,
this data may not be sufficient to support approval by the FDA or any other
U.S. or foreign regulatory approval. Pre-clinical and clinical data can be
interpreted in different ways. Accordingly, FDA officials could reach different
conclusions in assessing such data than we do, which could delay, limit or
prevent regulatory approval. In addition, the FDA, other regulatory
authorities, our Institutional Review Boards or we, may suspend or terminate
clinical trials at any time.
Unlike our Phase
III Nasolabial/Wrinkle trial, our Phase III Acne Scar trial is not subject to a
Special Protocol Assessment ("SPA") with the FDA. Isolagen has
validated a photo guide for use in the evaluators' assessment of acne study
subjects. Our evaluator assessment scale and photo guide have not yet been used
in a phase III clinical trial.
Any failure or
delay in completing clinical trials for our product candidates, or in receiving
regulatory approval for the sale of any product candidates, has the potential
to harm our business, and may prevent us from raising necessary, additional
financing that we may need in the future.
57
ITEM 6.
EXHIBITS
(a)
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: November 2, 2007
|
By:
|
/s/ Declan Daly
|
|
|
|
Declan Daly, Executive Vice President and Chief
Financial Officer
|
|
(Principal Financial Officer)
|
|
|
|
|
|
|
58
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