Armata Pharmaceuticals, Inc. - Quarter Report: 2006 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
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x
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QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2006
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934 FOR THE TRANSITION PERIOD FROM TO
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COMMISSION FILE NUMBER: 0-23930
TARGETED
GENETICS CORPORATION
(EXACT
NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
Washington
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91-1549568
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(State
of Incorporation)
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(I.R.S.
Employer Identification No.)
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1100
Olive Way, Suite 100 Seattle, WA 98101
(Address
of principal executive offices)(Zip Code)
(206)
623-7612
(Registrant’s
telephone number, including area code)
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to the filing requirements
for
at least the past 90 days. Yes x
No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer” and “large accelerated filer” in Rule 12b-2 of the Exchange Act.
(check one):
Large accelerated filer ¨ |
Accelerated
filer ý
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Non-accelerated
filer ¨
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). o
Yes
x
No
Shares
of
Common Stock, par value $0.01 per share, outstanding as of November 8, 2006:
10,896,898
TARGETED
GENETICS CORPORATION
Quarterly
Report on Form 10-Q
For
the
quarter ended September 30, 2006
TABLE
OF
CONTENTS
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Page No.
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PART I
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FINANCIAL
INFORMATION
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Item 1.
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Financial
Statements
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a)
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Condensed
Consolidated Balance Sheets at September 30, 2006 and December 31,
2005
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1
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b)
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Condensed
Consolidated Statements of Operations for the three and nine months
ended
September 30, 2006 and 2005
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2
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c)
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Condensed
Consolidated Statements of Cash Flows for the nine months ended September
30, 2006 and 2005
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3
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d)
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Notes
to Condensed Consolidated Financial Statements
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4
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Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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9
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Item
3.
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Quantitative
and Qualitative Disclosures About Market Risk
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16
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Item
4.
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Controls
and Procedures
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17
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PART
II
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OTHER
INFORMATION
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Item
1.
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Legal
Proceedings
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17
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Item
1A.
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Risk
Factors
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17
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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20
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Item
3.
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Defaults
Upon Senior Securities
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20
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Item
4.
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Submission
of Matters to a Vote of Security Holders
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20
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Item
5.
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Other
Information
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20
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Item
6.
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Exhibits
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20
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SIGNATURES
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21
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EXHIBIT
INDEX
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22
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i
PART
I FINANCIAL INFORMATION
Item
1. Financial
Statements
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
September
30,
|
December
31,
|
||||||
2006
|
2005
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
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9,280,000
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$
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14,122,000
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|||
Accounts
receivable
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613,000
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380,000
|
|||||
Prepaid
expenses and other
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635,000
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683,000
|
|||||
Total
current assets
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10,528,000
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15,185,000
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|||||
Property
and equipment, net
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1,282,000
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1,747,000
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|||||
Goodwill
|
7,926,000
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31,649,000
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|||||
Other
assets
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209,000
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217,000
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|||||
Total
assets
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$
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19,945,000
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$
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48,798,000
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LIABILITIES
AND SHAREHOLDERS’ EQUITY
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|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
1,895,000
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$
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1,770,000
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|||
Accrued
employee expenses
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500,000
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587,000
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|||||
Accrued
restructure charges
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655,000
|
1,838,000
|
|||||
Deferred
revenue
|
323,000
|
278,000
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|||||
Current
portion of long-term obligations
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3,195,000
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155,000
|
|||||
Total
current liabilities
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6,568,000
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4,628,000
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|||||
Accrued
restructure charges and deferred rent
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6,891,000
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5,422,000
|
|||||
Long-term
obligations
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5,002,000
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8,177,000
|
|||||
Commitments
and Contingencies
|
|||||||
Shareholders’ equity: | |||||||
Preferred
stock, $0.01
par value, 600,000 shares authorized:
|
|||||||
Series
A preferred stock, 180,000 shares designated, none issued and
outstanding
|
—
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—
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|||||
Common stock, $0.01 par value, 18,000,000 shares authorized, 9,896,898
shares issued and outstanding at September 30, 2006 and 8,569,424
shares
issued and outstanding at December 31, 2005
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99,000
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86,000
|
|||||
Additional paid-in capital
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286,200,000
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280,543,000
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|||||
Accumulated
deficit
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(284,835,000
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)
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(250,037,000
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)
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|||
Accumulated other comprehensive income (loss)
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20,000
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(21,000
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)
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||||
Total
shareholders’ equity
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1,484,000
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30,571,000
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|||||
Total
liabilities and shareholders’ equity
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$
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19,945,000
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$
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48,798,000
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1
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three
months ended
September
30,
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Nine
months ended
September
30,
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||||||||||||
2006
|
2005
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2006
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2005
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||||||||||
Revenue
under collaborative agreements
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$
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2,012,000
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$
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1,468,000
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$
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5,856,000
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$
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4,930,000
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|||||
Operating
expenses:
|
|||||||||||||
Research
and development
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3,123,000
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4,653,000
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10,483,000
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14,000,000
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|||||||||
General
and administrative
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1,687,000
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1,490,000
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4,736,000
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5,035,000
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|||||||||
Restructure
charges
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413,000
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1,188,000
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1,818,000
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1,526,000
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|||||||||
Goodwill
impairment charge
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—
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—
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23,723,000
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—
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|||||||||
Total
operating expenses
|
5,223,000
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7,331,000
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40,760,000
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20,561,000
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|||||||||
Loss
from operations
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(3,211,000
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)
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(5,863,000
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)
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(34,904,000
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)
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(15,631,000
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)
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|||||
Investment
income
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147,000
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315,000
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468,000
|
382,000
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|||||||||
Interest
expense
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(126,000
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)
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(135,000
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)
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(362,000
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)
|
(400,000
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)
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|||||
Net
loss
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$
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(3,190,000
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)
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$
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(5,683,000
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)
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$
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(34,798,000
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)
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$
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(15,649,000
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)
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Net
loss per common share (basic and diluted)
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$
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(0.32
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)
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$
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(0.66
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)
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$
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(3.64
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)
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$
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(1.83
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)
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Shares
used in computation of basic and diluted net loss per common
share
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9,894,000
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8,563,000
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9,548,000
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8,563,000
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See
accompanying notes to condensed consolidated financial statements
2
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine
months ended
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|||||||
September
30,
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|||||||
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2006
|
2005
|
|||||
Operating
activities:
|
|||||||
Net
loss
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$
|
(34,798,000
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)
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$
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(15,649,000
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)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
537,000
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1,009,000
|
|||||
Stock-based
compensation
|
691,000
|
—
|
|||||
Stock
issued to outside vendors
|
141,000
|
—
|
|||||
Goodwill
impairment charge
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23,723,000
|
—
|
|||||
Loss
(gain) on investments
|
(8,000
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)
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136,000
|
||||
Changes
in assets and liabilities:
|
|||||||
Increase in accounts receivable
|
(233,000
|
)
|
(207,000
|
)
|
|||
Decrease (increase) in prepaid expenses and other
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48,000
|
(173,000
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)
|
||||
Decrease in other assets
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8,000
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459,000
|
|||||
Increase in current liabilities
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38,000
|
4,000
|
|||||
Increase in deferred revenue
|
45,000
|
—
|
|||||
Increase in accrued restructure expenses and deferred rent
|
286,000
|
986,000
|
|||||
Net
cash used in operating activities
|
(9,522,000
|
)
|
(13,435,000
|
)
|
|||
Investing
activities:
|
|||||||
Purchases
of property and equipment
|
(72,000
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)
|
(618,000
|
)
|
|||
Proceeds
from sale of investments
|
49,000
|
46,000
|
|||||
Net
cash used in investing activities
|
(23,000
|
)
|
(572,000
|
)
|
|||
Financing
activities:
|
|||||||
Net
proceeds from sales of common stock
|
4,826,000
|
5,000
|
|||||
Proceeds
from the exercise of stock options
|
12,000
|
2,000
|
|||||
Repayment
of debt
|
—
|
(2,500,000
|
)
|
||||
Payments
under leasehold improvements and equipment financing
arrangements
|
(135,000
|
)
|
(445,000
|
)
|
|||
Net
cash provided by (used in) financing activities
|
4,703,000
|
(2,938,000
|
)
|
||||
Net
decrease in cash and cash equivalents
|
(4,842,000
|
)
|
(16,945,000
|
)
|
|||
Cash
and cash equivalents, beginning of period
|
14,122,000
|
34,096,000
|
|||||
Cash
and cash equivalents, end of period
|
$
|
9,280,000
|
$
|
17,151,000
|
|||
See
accompanying notes to condensed consolidated financial statements
3
TARGETED
GENETICS CORPORATION
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Summary
of Significant Accounting Policies
Basis
of Presentation
The
unaudited condensed consolidated financial statements included in this quarterly
report have been prepared by Targeted Genetics Corporation, or Targeted
Genetics, according to the rules and regulations of the Securities and Exchange
Commission, or SEC, and according to accounting principles generally accepted
in
the United States of America, or GAAP, for interim financial statements. The
accompanying balance sheet information as of December 31, 2005 is derived from
our audited financial statements. Certain information and footnote disclosures
normally included in financial statements prepared in accordance with GAAP
have
been omitted in accordance with the SEC’s rules and regulations for interim
financial statements. Our condensed consolidated financial statements include
the accounts of Targeted Genetics and our inactive, wholly-owned subsidiaries,
Genovo, Inc. and TGCF Manufacturing Corporation.
All
significant intercompany transactions have been eliminated in consolidation.
The
financial statements reflect, in the opinion of management, all adjustments
which consist solely of normal recurring adjustments necessary to present fairly
our financial position and results of operations as of and for the periods
indicated. Certain reclassifications have been made to conform prior period
results to the current period presentation.
We
do not
believe that our results of operations for the three and nine months ended
September 30, 2006 are necessarily indicative of the results to be expected
for
the full year.
The
unaudited condensed consolidated financial statements included in this quarterly
report should be read in conjunction with our audited consolidated financial
statements and related footnotes included in our annual report on Form 10-K
for
the year ended December 31, 2005.
On
May 8,
2006, the Company’s Board of Directors approved a 1-for-10 reverse stock split,
which became effective on May 11, 2006. All references to common stock, common
shares outstanding, average number of common shares outstanding, per share
amounts and options in these financial statements and notes to financial
statements have been restated to reflect the 1-for-10 common stock reverse
split
on a retroactive basis.
Our
combined cash and cash equivalents total $9.3 million at September 30, 2006.
We
expect that these funds plus the funding we expect from our partners will be
sufficient to fund our operations into the first quarter of 2007. This estimate
is based on our ability to perform planned research and development activities
and the receipt of planned funding from our collaborators. Our near-term
financing strategy includes leveraging our development capabilities and
intellectual property assets into additional capital raising opportunities,
advancing our clinical development programs and accessing the public and private
capital markets at appropriate times. Additional funding may not be available
to
us on reasonable terms, if at all. Depending on our ability to successfully
access additional funding, we may be forced to take cost reduction measures
that
may include scaling back, delaying or terminating one or more research and
development programs, curtailing capital expenditures or reducing other
operating activities. We have prepared the accompanying financial statements
assuming that we will continue as a going concern and our financial statements
do not reflect adjustments that may impact the amount and classifications of
assets or liabilities that may result from these liquidity
uncertainties.
Stock-Based
Compensation
4
2. Long-Term
Obligations
Long-term
obligations consisted of the following:
|
September
30,
|
December
31,
|
|||||
2006
|
2005
|
||||||
Loans
payable to Biogen Idec
|
$
|
8,150,000
|
$
|
8,150,000
|
|||
Equipment
financing obligations
|
47,000
|
182,000
|
|||||
Total
obligations
|
8,197,000
|
8,332,000
|
|||||
Less
current portion
|
(3,195,000
|
)
|
(155,000
|
)
|
|||
Total
long-term obligations
|
$
|
5,002,000
|
$
|
8,177,000
|
As
of
September 30, 2006 we had $7.5 million of principle remaining on a $10.0
million
note payable to Biogen Idec, a beneficial owner of approximately 11.8% of
our
outstanding common shares. Outstanding borrowings under this unsecured loan
agreement bear interest at the one-year London Interbank Offered Rate, or
LIBOR,
plus 1%, which is reset quarterly. The loan contains financial covenants
establishing limits on our ability to declare or pay cash dividends and
scheduled principal payments of $2.5 million are due August 1 2007, 2008
and
2009 with interest due each year on August 31. In addition, we have agreed
to
apply one-third of certain up-front payments received from potential future
corporate collaborations to the outstanding balance on this loan payable,
first
to repayment of any accrued and unpaid interest and second to the repayment
of
outstanding principal in reverse order of maturity. As of September 30, 2006
we
also had a second loan, a promissory note payable to Biogen Idec, which we
assumed in 2000 as part of our acquisition of Genovo. At September 30, 2006,
this promissory note had an outstanding principal balance of $650,000, bore
no
interest and was scheduled to mature in August 2007.
On
November 7, 2006, we signed an agreement to restructure $8.15 million of
debt
payable to Biogen Idec. Under the agreement, we converted $5.65 million of
debt
into one million shares of common stock issued to Biogen Idec. At the time
of
signing we made a payment of $500,000 towards the remaining loan balance.
The
remaining $2.0 million principal balance continues to bear interest at the
rate
of LIBOR plus 1% and is to be paid in two equal installments of $1.0 million
each on August 1, 2007 and 2008. See Note 7 to the condensed consolidated
financial statements for the terms of the restructuring.
3. Accrued Restructure Charges
We
apply
the provisions of SFAS No. 146, “Accounting
for Costs Associated with Exit or Disposal Activities,” as
it
relates to our facility in Bothell, Washington and record restructure charges
on
the operating lease for the facility as a result of our 2003 decision to
discontinue use of the facility. Accrued restructure charges represent our
best
estimate of the fair value of the liability as determined under SFAS No. 146
and
are computed as the fair value of the difference between the remaining lease
payments, net of assumed sublease income and expense. We also record accretion
expense based upon changes in the accrued liability that results from the
passage of time at an assumed discount rate of 10%. Accretion expense is
recorded on an ongoing basis through the end of the lease term in September
2015
and is reflected as a restructuring charge in the accompanying condensed
consolidated statements of operations.
The
table
below presents a reconciliation of the accrued restructure liability for the
nine month period ended September 30, 2006:
Contract
Termination Costs
|
Employee
Termination
Benefits |
Total
|
||||||||
December
31, 2005 accrued liability
|
$
|
7,149,000
|
$
|
—
|
$
|
7,149,000
|
||||
Charges incurred
|
1,033,000
|
221,000
|
1,254,000
|
|||||||
Adjustments to the liability (accretion)
|
564,000
|
—
|
564,000
|
|||||||
Amount paid
|
(1,211,000
|
)
|
(221,000
|
)
|
(1,432,000
|
)
|
||||
September
30, 2006 accrued liability
|
$
|
7,535,000
|
$
|
—
|
$
|
7,535,000
|
During
the first quarter of 2006 we recorded additional restructure charges of $639,000
as a result of updating our estimates of costs and sublease income associated
with exiting the Bothell facility. Market conditions for subleasing the facility
continued to be poor, therefore, we extended our estimate for additional time
that may be required to find a sublease tenant. In addition, we reviewed and
adjusted downward our assumptions surrounding escalation in sublease rental
income. In the third quarter of 2006 we recorded additional restructure charges
of $221,000 as a result of further extending the anticipated lead time for
subleasing the facility. In addition to these adjustments to the accrued
restructure liability we have incurred $188,000 of accretion expense for the
three month period ending September 30, 2006 and $564,000 of accretion expense
for the nine month period ending September 30, 2006. The total of these charges
and adjustments to the liability are reflected as restructure charges in the
accompanying condensed consolidated statement of operations.
5
Restructuring
charges also includes $221,000 of employee termination benefits recognized
during the first quarter of 2006 related to the restructuring announced in
January 2006 in order to reduce expenses and realign resources to advance our
inflammatory arthritis product through clinical trials. We reduced our workforce
by 26 employees, primarily in early-stage research and development groups and
in
operational and general and administrative functions.
In
May
2006, we amended the lease for our Seattle location which reduced our square
footage three years before the end of the original lease term. We entered into
this modification to reduce operating costs. Expenses related to the termination
of the lease totaling $173,000 are included in restructuring charges for the
three and nine months ending September 30, 2006.
Through
September 30, 2006, we have recorded contract termination costs totaling $9.8
million for our Bothell facility. We expect to incur an additional $3.2 million
in accretion expense and pay $13.6 million in rent through the expiration of
the
Bothell lease in September 2015.
We
periodically evaluate our restructuring estimates and assumptions and record
additional restructure charges as necessary. Because restructure charges are
estimates based upon assumptions regarding the timing and amounts of future
events, significant adjustments to the accrual may be necessary in the future
based on the actual outcome of events and as we become aware of new facts and
circumstances.
4.
Equity
Financing
On
March
10, 2006, we sold 1,279,161 shares of our common stock in a registered offering
at a price of $3.90 per share and received net proceeds of approximately $4.8
million.
Stock
Compensation
We
have
various stock option plans, or Option Plans, that provide for the issuance
of
nonqualified and incentive stock options to acquire up to 1,297,944 shares
of
our common stock. These stock options may be granted by our Board of Directors
to our employees, directors and officers and to consultants, agents, advisors
and independent contractors who provide services to us. The exercise price
for
incentive stock options shall not be less than the fair market value of the
shares on the date of grant. Options granted under our Option Plans expire
no
later than ten years from the date of grant and generally vest and become
exercisable over a four-year period following the date of grant. In May and
June
of 2006, as part of an employee retention plan, we granted options to purchase
an aggregate of 306,500 shares of common stock with an accelerated twelve month
vesting period. We granted a total of 198,000 of these options to purchase
shares of common stock with exercise prices of $3.80, exceeding the $2.46 fair
value of the common stock on the grant date. Every non-employee member of our
Board of Directors receives an annual nonqualified stock option grant and these
options vest over a twelve month period provided they continue service to us.
Stock option exercises are fulfilled through the issuance of new shares of
common stock.
Effective
January 1, 2006, we adopted SFAS No. 123R, “Share-Based
Payment.”
SFAS No.
123R requires us to expense the fair value of stock options granted over the
vesting period. We have adopted SFAS No. 123R using the modified prospective
application method and recognized $227,000 of stock-based compensation expense
in the third quarter of 2006 and $691,000 for the nine months ending September
30, 2006. This compensation expense includes: (a) compensation cost for all
share-based stock options granted prior to, but not yet vested as of January
1,
2006, based on the grant-date fair value used for prior pro forma disclosures
adjusted for forfeitures and (b) compensation cost for all share-based payments
granted subsequent to January 1, 2006, based on the grant-date fair value
estimate in accordance with the provisions of SFAS No. 123R. For the three
months ended September 30, 2006, we classified $117,000 of the stock-based
compensation expense as research and development expense and $110,000 as general
and administrative expense. For the nine months ended September 30, 2006 we
classified $379,000 as research and development expense and $312,000 as general
and administrative expense. As of September 30, 2006, total unrecognized
compensation cost related to unvested options was approximately $835,000, net
of
estimated forfeitures, which we expect to recognize over a weighted average
period of approximately 9.5 months.
Prior
to
January 1, 2006, we presented pro forma disclosure of stock-based compensation
expense under SFAS No. 123, “Accounting
for Stock-Based Compensation,”
and
accounted for stock options under Accounting Principles Board No. 25,
“Accounting
for Stock Issued to Employees,”
which
uses the intrinsic value method and generally recognizes no compensation cost
for employee stock option grants. The following table illustrates the effect
on
net loss and loss per share amounts if we had applied the fair value recognition
provisions of SFAS No. 123 to stock-based employee compensation for the three
months and nine months ended September 30, 2005:
6
Three
months
ended
|
Nine
months
ended
|
||||||
September
30, 2005
|
September
30, 2005
|
||||||
Net
loss:
|
|||||||
As
reported
|
$
|
(5,683,000
|
)
|
$
|
(15,649,000
|
)
|
|
Pro
forma stock-based compensation expense
|
(374,000
|
)
|
(1,242,000
|
)
|
|||
Pro
forma
|
$
|
(6,057,000
|
)
|
$
|
(16,891,000
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||
As
reported
|
$
|
(0.66
|
)
|
$
|
(1.83
|
)
|
|
Pro
forma
|
(0.71
|
)
|
(1.97
|
)
|
The
following is a summary of our stock option activity and related prices for
the
first nine months of 2006:
Shares
|
Weighted
Average
Exercise
Price
|
||||||
Balance,
December 31, 2005
|
704,071
|
$
|
20.84
|
||||
Granted
|
336,100
|
3.33
|
|||||
Exercised
|
(3,350
|
)
|
3.44
|
||||
Forfeited
|
(129,265
|
)
|
15.17
|
||||
Balance,
September 30, 2006
|
907,556
|
15.23
|
The
weighted average fair value of stock options granted during the nine months
ending September 30, 2006 was $1.84 per share and was $6.80 per share for the
nine months ending September 30, 2005. The weighted average remaining
contractual term of options currently exercisable as of September 30, 2006
is
6.15 years and was 5.93 years for options exercisable at September 30,
2005. We
received $12,000 from the exercise of stock options for the nine months ending
September 30, 2006.
Stock
options outstanding and exercisable as of September 30, 2006 are summarized
below:
Outstanding
|
Exercisable
|
|||||||||||||||
Range
of Exercise Prices
|
Number
of
Option
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Life
(Years)
|
Number
of
Option
Shares
|
Weighted
Average
Exercise
Price
|
|||||||||||
$
1.80 - $2.90
|
128,420
|
$
|
2.53
|
9.16
|
54,064
|
$
|
2.65
|
|||||||||
3.80
|
212,000
|
3.80
|
9.70
|
49,499
|
3.80
|
|||||||||||
4.30
- 12.20
|
188,834
|
7.91
|
7.47
|
116,876
|
7.63
|
|||||||||||
12.60
- 15.60
|
187,613
|
13.33
|
7.28
|
120,395
|
13.45
|
|||||||||||
15.90 - 148.80
|
190,689
|
45.60
|
3.65
|
187,409
|
45.98
|
|||||||||||
Balance,
September 30, 2006
|
907,556
|
15.23
|
7.39
|
528,243
|
21.69
|
The
total
intrinsic value of stock options is summarized as follows:
Number
of
Option Shares |
Aggregate
Intrinsic Value |
||||||
Options
outstanding at September 30, 2006
|
907,556
|
$
|
—
|
||||
Options
exercisable at September 30, 2006
|
528,243
|
—
|
|||||
Options
exercised during the nine months ended September 30, 2006
|
3,350
|
3,199
|
7
The
aggregate intrinsic value is determined using the closing price of our common
stock on September 30, 2006 of $1.81 per share. The fair value of each stock
option award is estimated on the date of the grant using the
Black-Scholes-Merton option pricing model. The following are the weighted
average assumptions for the periods noted:
Nine
Months ended September 30,
|
|||||||
2006
|
2005
|
||||||
Expected
dividend rate
|
Nil
|
Nil
|
|||||
Expected
stock price volatility range
|
1.067-1.107
|
1.116-1.122
|
|||||
Risk-free
interest rate range
|
4.25-4.85
|
%
|
3.25-4.13
|
%
|
|||
Expected
life of options range
|
4-5
years
|
4
years
|
The
risk-free interest rate is based on the U.S. treasury security rate. We estimate
the expected life of options and the expected volatility ranges based on our
historical data.
5.
Goodwill
The
table
below reflects changes in the balance related to goodwill for the nine months
ended September 30, 2006:
December
31, 2005 goodwill balance
|
$
|
31,649,000
|
||
Impairment charge
|
(23,723,000
|
)
|
||
September
30, 2006 goodwill balance
|
$
|
7,926,000
|
We
perform goodwill impairment tests in accordance with SFAS No. 142, “Goodwill
and Other Intangible Assets”
on an
annual basis or more frequently if events and changes in business conditions
indicate that the carrying amount of our goodwill may not be recoverable.
Normally, we perform our annual impairment test as of October 1.
However,
as a
result of a decline in our traded share price of our common stock during June
2006, to a level which reduced our market capitalization to an amount less
than
the fair value of the Company’s net assets, we concluded that this was an
indicator of impairment of our goodwill and therefore, we were required to
perform an interim goodwill impairment test. In the first step of this testing,
since the Company is comprised of only one reporting unit, we compared the
fair
value of the Company, as measured by market capitalization and discounted cash
flow analysis, to the net carrying value of our assets. Since the indicated
fair
value of the Company was less than the net carrying value of our assets, we
were
then required to perform the second step of the evaluation and measure the
amount of the impairment loss. This analysis requires us to determine the
implied value of goodwill by allocating the estimated fair value of the Company
to its assets and liabilities including intangible assets such as in-process
research and development, completed technology, and trademarks and trade names
using a hypothetical purchase price allocation as if the Company had been
acquired in a business combination as of the date of the impairment test. This
evaluation resulted in an implied goodwill balance of $7.9 million and a second
quarter 2006 non-cash goodwill impairment charge of $23.7 million.
6.
Other Comprehensive Loss
Comprehensive
loss is the total of net loss and all other non-owner changes in equity.
Comprehensive loss includes unrealized gains and losses from investments and
foreign currency translations, as presented in the following table:
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
||||||||||||
|
2006
|
|
2005
|
|
2006
|
|
2005
|
||||||
Net
loss as reported
|
$
|
(3,190,000
|
)
|
$
|
(5,683,000
|
)
|
$
|
(34,798,000
|
)
|
$
|
(15,649,000
|
)
|
|
Other
comprehensive loss:
|
|||||||||||||
Unrealized
gain (loss) on available-for-sale securities
|
(22,000
|
)
|
48,000
|
26,000
|
48,000
|
||||||||
Foreign
currency translation adjustment
|
2,000
|
7,000
|
15,000
|
7,000
|
|||||||||
Other
comprehensive loss
|
$
|
(3,210,000
|
)
|
$
|
(5,628,000
|
)
|
$
|
(34,757,000
|
)
|
$
|
(15,594,000
|
)
|
|
8
7.
Subsequent Events
On
November 7, 2006, we signed an agreement to restructure $8.15 million of debt
payable to Biogen Idec. Under the agreement, we converted $5.65 million of
debt
into one million shares of common stock issued to Biogen Idec. At the time
of
signing we made a payment of $500,000 towards the remaining loan balance. The
remaining $2.0 million principal balance continues to bear interest at the
rate
of LIBOR plus 1% and is to be paid in two equal installments of $1.0 million
each on August 1, 2007 and 2008. In addition, the agreement provides for early
repayment of the 2007 installment within thirty days of a change in control
of
the Company. Several of the provisions of the modified loan agreement entered
into in September 2005 continue including the requirement to apply one-third
of
certain up-front payments received from potential future corporate
collaborations to the outstanding balance on this loan payable.
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
Forward-Looking
Statements
This
quarterly report on Form 10-Q contains forward-looking statements that involve
risks and uncertainties. Forward-looking statements include statements about
our
product development and commercialization goals and expectations, potential
market opportunities, our plans for and anticipated results of our clinical
development activities and the potential advantage of our product candidates,
our future cash requirements and the sufficiency of our cash and cash
equivalents to meet these requirements, our ability to raise capital when needed
and other statements that are not historical facts. Words such as “may,” “will,”
“believes,” “estimates,” “expects,” “anticipates,” “plans” and “intends,” or
statements concerning “potential” or “opportunity” and other words of similar
meaning or the negative thereof, may identify forward-looking statements, but
the absence of these words does not mean that the statement is not
forward-looking. In making these statements, we rely on a number of assumptions
and make predictions about the future. Our actual results could differ
materially from those stated in, or implied by; forward-looking statements
for a
number of reasons, including the risks described in the section entitled “Risk
Factors” in Part II, Item 1A of this quarterly report.
You
should not unduly rely on these forward-looking statements, which speak only
to
our expectations as of the date of this quarterly report. We undertake no
obligation to publicly revise any forward-looking statement after the date
of
this quarterly report to reflect circumstances or events occurring after the
date of this quarterly report or to conform the statement to actual results
or
changes in our expectations. You should, however, review the factors, risks
and
other information we provide in the reports we file from time to time with
the
Securities and Exchange Commission, or SEC.
BUSINESS
OVERVIEW
Targeted
Genetics Corporation is a clinical-stage biotechnology company. We are at the
forefront of developing a new class of gene-based products. We believe that
a
wide range of diseases may be treated or prevented with gene-based products.
In
addition to treating diseases which have not had treatments in the past, we
believe that there is also a significant opportunity to use gene-based products
to more effectively treat diseases that are currently treated using other
therapeutic classes of drugs including proteins, monoclonal antibodies, or
small
molecule drugs. We have multiple product candidates, two of which are currently
in clinical trials. Our clinical-stage candidates are aimed at inflammatory
arthritis and HIV/AIDS. Our preclinical product candidates are in development
with a variety of collaboration partners and are aimed at congestive heart
failure, HIV/AIDS and Huntington’s disease.
Our
product candidates consist of a delivery vehicle, called a vector, and genetic
material. The role of the vector is to carry the genetic material into a target
cell. Once delivered into the cell, the gene can express or direct production
of
the specific proteins encoded by the gene. Gene delivery may be used to treat
disease by replacing the missing or defective gene to facilitate the normal
protein production or gene regulation capabilities of cells. In addition, gene
delivery may be used to enable cells to perform additional roles in the body.
Gene delivery may also be used to shut down cellular functions.
We
are a
leader in the preclinical and clinical development of adeno-associated viral
vector, or AAV-based gene products and in the manufacture of AAV-vectors.
Through our research and development activities, we have developed expertise
and
intellectual property related to gene delivery technologies. We have developed
and applied processes to manufacture our potential products at a scale amenable
to late-stage clinical development and expandable to large-scale commercial
production. We have established broad capabilities in applying our AAV-based
gene delivery technologies to several indications, and we have developed an
infrastructure that allows us to expand these capabilities into multiple product
opportunities. We have treated over 250 subjects using AAV-based products with
no major safety concerns.
9
We
are
primarily focused on the following product development programs:
Description
|
Indication
|
Funding
Partner
|
Development
Status
|
AAV
delivery of TNF-alpha antagonist (tgAAC94)
|
Inflammatory
Arthritis
|
Phase
I/II
|
|
AAV
delivery of HIV antigens (tgAAC09)
|
HIV/AIDS
|
IAVI
|
Phase
II
|
AAV
delivery of HIV antigens
|
HIV/AIDS
|
NIAID
|
Preclinical
|
AAV
delivery of SERCA2a
|
Congestive
Heart Failure
|
Celladon
|
Preclinical
|
AAV
expression of htt siRNA
|
Huntington’s
disease
|
Sirna
|
Preclinical
|
In
June
2006, we reported preliminary data from our ongoing Phase I/II trial of tgAAC94
in patients with inflammatory arthritis. In the study, approximately 120 adults
are being randomized into three dose groups to receive a single intra-articular
injection of either tgAAC94 or a placebo, followed by an open-label injection
of
tgAAC94 after 12 to 30 weeks, depending on when the target joint meets criteria
for re-injection. To date, approximately 40 subjects have received an injection
of blinded study drug or placebo. Preliminary data indicate tgAAC94 is safe
and
well-tolerated at doses of up to 5x10(12) particles, or DRP, /mL in subjects
with and without systemic TNF-alpha antagonists. Data from the first cohort
of
subjects treated with doses of 1x10(11) DRP/mL of joint volume demonstrate
a
trend toward sustained improvement in tenderness and swelling in treated joints,
compared to placebo. Additionally, fewer patients receiving tgAAC94 had symptoms
requiring re-injection at the 12-week time point, compared with patients in
the
placebo arm. Although the numbers are small, the data also suggest a trend
toward greater responses to tgAAC94 in patients taking systemic TNF-alpha
antagonist therapy compared with patients not on these therapies. We are
continuing to follow the subjects and plan on reporting additional results
in
the fourth quarter of 2006.
In
August
2006, we reported interim data from a Phase I clinical trial of tgAAC09, an
investigational HIV/AIDS vaccine candidate based upon recombinant
adeno-associated virus vector serotype 2, or AAV2. Our collaborative partner,
the International AIDS Vaccine Initiative (IAVI), is conducting this trial.
IAVI
enrolled healthy volunteers from Belgium, Germany and India who were not
infected with HIV. The Phase I trial is primarily designed to evaluate safety
and tolerability of the vaccine at escalating dose levels and is also designed
to evaluate immune responses following vaccination. No safety concerns were
identified and the vaccine was well tolerated. In a subset of the volunteers
receiving a single administration of the highest dose of the vaccine, modest
immune responses to the HIV antigens were observed. A second clinical trial
of
tgAAC09 is ongoing in South Africa, Uganda and Zambia to evaluate a higher
dose
and to systematically evaluate the utility and optimal timing of boost
vaccination.
Our
recorded goodwill originated with our acquisition of Genovo, Inc. in September,
2000. As a result of a decline in our share price during June 2006, to a level
which reduced our market capitalization to an amount less than the fair value
of
the Company’s net assets, we were required to perform an interim goodwill
impairment test. This impairment test resulted in the second quarter 2006
recognition of a loss on impairment of goodwill in the amount of $23.7 million.
This non-cash charge resulted both from the decline in the Company’s fair value
(as indicated by the decline in our share price) as well as the calculation
of
implied goodwill resulting from a hypothetical allocation of the Company’s fair
value to the fair value of its assets and liabilities including intangible
assets as if the Company had been acquired in a hypothetical business
combination on the date of the impairment test.
We
have
financed our operations primarily through proceeds from public and private
sales
of our equity securities, through cash payments received from our collaborative
partners for product development and manufacturing activities, through proceeds
from the issuance of debt and loan funding under equipment financing
arrangements.
Our
expenses are primarily incurred in conducting our research and development
programs, the conduct of preclinical studies and clinical trials and general
and
administrative support for these activities and accordingly, to an extent,
we
are able to reduce expenses and conserve our resources by reducing these
activities. For example, in January 2006 we restructured our operations to
concentrate our resources on generating data from the clinical trials of our
inflammatory arthritis product candidate, maintaining our manufacturing
capabilities and advancing our partner funded product development efforts.
As
part of this restructuring we eliminated 26 positions, which reduced our
workforce by approximately 27%, including scientific, operations and
administrative functions that were not required to support our programs.
As
of
September 30, 2006, our accumulated deficit totaled $284.8 million and our
shareholders’ equity totaled $1.5 million. We expect to generate substantial
additional losses for the foreseeable future, primarily due to the costs
associated with the development of our research and development programs, the
conduct of preclinical studies and clinical trials and general and
administrative support for these activities.
10
Notwithstanding
our January 2006 cost-cutting measures, we will require access to significant
amounts of capital in order to successfully develop our lead inflammatory
arthritis product candidate and our partnered product candidates. We may be
unable to obtain required funding when needed or on acceptable terms, obtain
or
maintain corporate partnerships or complete acquisition transactions necessary
or desirable to complete the development of our product candidates.
Over
the
longer term, our business strategy is to leverage our technology assets,
manufacturing capabilities and gene therapy product development expertise into
multiple development programs and collaborations to maximize our opportunities
to commercialize a product candidate. We believe that, if successful, our
product candidates will have significant market potential. We intend to pursue
product development programs that enable us to demonstrate the potential of
our
technology and eventually to commercialize gene-based therapeutics that address
currently unmet medical needs.
The
development of pharmaceutical products, including our potential inflammatory
arthritis, prophylactic HIV/AIDS vaccine, congestive heart failure, and
Huntington’s disease product candidates discussed above, involves extensive
preclinical development followed by human clinical trials that take several
years or more to complete. The length of time required to completely develop
any
product candidate varies substantially according to the type, complexity and
novelty of the product candidate, the degree of involvement by a development
partner and the intended use of the product candidate. Our commencement and
rate
of completion of clinical trials may vary or be delayed for many reasons,
including those discussed in the section entitled “Risk Factors” presented
below.
CRITICAL
ACCOUNTING POLICIES, ESTIMATES AND ASSUMPTIONS
Other
than with respect to those items described below, there have been no material
changes from the critical accounting policies, estimates and assumptions as
disclosed in Item 7 Management’s Discussion and Analysis of Financial Condition
and Results of Operations of the Company’s Annual Report on Form 10-K for the
year ended December 31, 2005. The critical accounting policies, estimates and
assumptions below have been updated to provide more recent financial and factual
information as of September 30, 2006.
Goodwill
When
we
purchased Genovo, Inc. in 2000 we recorded intangible assets of $39.5 million
on
our financial statements, which represented know-how, an assembled workforce
and
goodwill. Between 2000 and 2002 we recognized $8.1 million of amortization
of
the goodwill and intangible assets and in 2002 we implemented SFAS No. 142,
“Goodwill
and Other Intangible Assets”.
SFAS
No. 142 discontinued amortization of goodwill and requires us to perform
goodwill impairment tests annually or more frequently if events and changes
in
business conditions indicate that the carrying amount of our goodwill may not
be
recoverable. We assess any potential impairment using a two-step process. Since
we have only one reporting unit for purposes of applying SFAS No. 142, the
first
step requires us to compare the fair value of the total Company, as measured
by
market capitalization to the company’s net book value. If the fair value of the
company is greater, then no impairment is indicated. If the fair value of the
Company is less then the net carrying value of its assets, then we are required
to perform the second step to determine the amount, if any, of goodwill
impairment. In step two, the implied fair value of goodwill is calculated and
compared to its carrying amount. If the goodwill carrying amount exceeds the
implied fair value, an impairment loss must be recognized equal to that excess.
The implied goodwill amount is determined by allocating the fair value of the
Company to all of its assets and liabilities including intangible assets such
as
in process research and development and developed technology as if the company
had been acquired in a hypothetical business combination as of the date of
the
impairment test. The Company engaged an independent valuation firm to assist
with the evaluation, including the assessment of the estimated fair value of
the
Company and the hypothetical purchase price allocations.
As
a
result of an interim goodwill impairment test performed in the second quarter
of
2006, we recognized a non-cash loss on impairment of goodwill of $23.7 million
based on an assessment that the implied value of goodwill was $7.9
million.
The
process of evaluating the potential impairment of goodwill is subjective and
requires significant judgment. In estimating the fair value of the Company,
we
make estimates and judgments about its future revenues and cash flows,
application of a discount rate, and the potential control premium relative
to
the market price of the Company’s stock at the valuation date. In estimating the
fair value of the Company’s net assets, including intangible assets we make
estimates and judgments relating to the fair value of specific assets and
liabilities. These estimates generally involve projections of the cash flows
which may be provided by specific assets such as in process research and
development, completed technology and trademarks and trade names, including
assumptions as to the probability of bringing drug candidates to market, the
timing of product development, the market size addressed by our potential
products, and the application of discount rates. Changes in these estimates
could impact the Company’s conclusion as to whether an impairment has occurred
and could also significantly impact the amount of impairment recorded.
11
Stock-Based
Compensation
Prior
to
January 1, 2006, we had applied the intrinsic value method of accounting for
stock options granted to our employees and directors under the provisions of
Accounting Principles Board Opinion No. 25, “Accounting
for Stock Issued to Employees”,
and
related interpretations, as permitted by SFAS No. 123 “Accounting
for Stock-Based Compensation.”
Accordingly, we did not recognize any compensation expense for options granted
to employees or directors because we grant all options at fair market value
on
the date of grant.
On
January 1, 2006, we adopted SFAS No. 123R, “Share-Based
Payment.”
We have
adopted the SFAS No. 123R fair value recognition provisions using the modified
prospective transition method. Under the modified prospective method,
compensation expense includes: (a) compensation cost for all share-based stock
options granted prior to, but not yet vested as of January 1, 2006, based on
the
grant-date fair value used for prior pro forma disclosures adjusted for
forfeitures and (b) compensation cost for all share-based payments granted
subsequent to January 1, 2006, based on the grant-date fair value estimate
in
accordance with the provisions of SFAS No. 123R. Results for periods prior
to
January 1, 2006 have not been restated. As a result of adopting SFAS No. 123R,
we recorded $227,000 of expense for stock-based compensation for the three
months ending September 30, 2006 and $691,000 for the nine months ending
September 30, 2006. This expense is classified as follows:
|
Three
months ended
September 30, 2006 |
Nine
months ended
September 30, 2006 |
|||||
Research
and development
|
$
|
117,000
|
$
|
379,000
|
|||
General
and administrative
|
110,000
|
312,000
|
|||||
Total
stock-based compensation
|
$
|
227,000
|
$
|
691,000
|
The
proforma cost of stock option compensation for the three months ended September
30, 2005 was $374,000 and the proforma cost of stock option compensation for
the
nine months ending September 30, 2005 was $1,242,000 for which no expense was
recorded as allowed under the provisions of APB Opinion No. 25. As of September
30, 2006, total unrecognized compensation cost related to unvested options
was
approximately $835,000, net of estimated forfeitures, which we expect to
recognize over a weighted average period of approximately 9.5 months.
Determining
the appropriate fair value model and calculating the fair value of share-based
payment awards require the input of highly subjective assumptions, including
the
expected life of the share-based payment awards and stock price volatility.
We
based our volatility and expected life estimates based on our historical data.
The assumptions used in calculating the fair value of share-based payment awards
represent our best estimates, but these estimates involve inherent uncertainties
and the application of judgment. As a result, if factors change and we use
different assumptions, our stock-based compensation expense could be materially
different in the future. In addition, we are required to estimate the expected
forfeiture rate and only recognize expense for those shares expected to vest.
If
our actual forfeiture rate is materially different from our estimate, the
stock-based compensation expense could be significantly different from what
we
have recorded in the current period. See Note 4 to the condensed consolidated
financial statements for a further discussion on stock-based
compensation.
RESULTS
OF OPERATIONS
Revenue
Revenue
for the three months ending September 30, 2006 increased to $2.0 million
compared to $1.5 million for the same period in 2005. Revenue increased to
$5.9
million for the nine months ended September 30, 2006 compared to $4.9 million
for the same period in 2005. The increase in revenue reflects higher research
and development activities under our collaboration with Celladon and research
and development activities under the National Institute of Allergy and
Infectious Disease, or NIAID, contract initiated in Q4-2005. These increases
were partially offset by decreased research and development activities from
our
collaboration with IAVI. We expect that our revenue for the remainder of 2006
will consist primarily of research and development revenue earned under our
collaborations with Celladon, the NAID and IAVI. For the next several years,
our
revenue will depend on the continuation of the current collaborations and our
success with entering into and performing under new collaborations.
12
Operating
Expenses
Research
and Development Expenses. Research
and development expenses decreased to $3.1 million for the three months ended
September 30, 2006 compared to $4.7 million for the same period in 2005. This
decrease reflects lower preclinical costs incurred as a result of the January
2006 restructuring and lower costs related to our cystic fibrosis project
partially offset by higher expenses in support of our inflammatory arthritis
program. Research and development expense decreased to $10.5 million for the
nine months ended September 30, 2006 compared to $14.0 million for the same
period in 2005. This decrease reflects lower costs related to our HIV/AIDS
vaccine collaboration with IAVI and reduced costs related to our cystic fibrosis
project offset by increases in development efforts related to our inflammatory
arthritis project and lower costs as a result of the restructuring efforts
implemented in January 2006.
The
following is an allocation of our total research and development costs between
our programs in clinical development and those that are in research or
preclinical stages of development:
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
||||||||||||
|
2006
|
2005
|
2006
|
2005
|
|||||||||
Programs
in clinical development:
|
|||||||||||||
HIV/AIDS
vaccine
|
$
|
383,000
|
$
|
337,000
|
$
|
1,494,000
|
$
|
2,325,000
|
|||||
Inflammatory
arthritis
|
771,000
|
615,000
|
2,204,000
|
1,782,000
|
|||||||||
Cystic
fibrosis (1)
|
2,000
|
191,000
|
37,000
|
465,000
|
|||||||||
Indirect
costs
|
554,000
|
889,000
|
2,150,000
|
3,499,000
|
|||||||||
Total
clinical development program expense
|
1,710,000
|
2,032,000
|
5,885,000
|
8,071,000
|
|||||||||
Research
and preclinical development program expense
|
1,413,000
|
2,621,000
|
4,598,000
|
5,929,000
|
|||||||||
Total
research and development expense
|
$
|
3,123,000
|
$
|
4,653,000
|
$
|
10,483,000
|
$
|
14,000,000
|
(1) No
longer in development.
Research
and development costs attributable to programs in clinical development include
the costs of salaries and benefits, clinical trial costs, outside services,
materials and supplies incurred to support the clinical programs. Indirect
costs
allocated to clinical programs include facility and building occupancy costs,
research and development administrative costs, and license and royalty payments.
These costs are further allocated between clinical and preclinical programs
based on relative levels of program activity. IAVI separately manages and funds
the clinical trial costs of our AIDS vaccine program. As a result, we do not
include those costs in our research and development expenses.
Costs
attributed to research and preclinical programs represent our earlier-stage
development activities and include costs incurred for the HIV/AIDS vaccine
development activities under the NIAID contract and the congestive heart failure
programs as well as other programs prior to their transition into clinical
trials. Research and preclinical program expense also includes costs that are
not allocable to a clinical development program, such as unallocated
manufacturing infrastructure costs. Because we conduct multiple research
projects and utilize resources across several programs, our research and
preclinical development costs are not directly assigned to individual programs.
For
purposes of reimbursement from our collaboration partners, we capture the level
of effort expended on a program through our project management system, which
is
based primarily on human resource time allocated to each program, supplemented
by an allocation of indirect costs and other specifically identifiable costs,
if
any. As a result, the costs allocated to programs identified in the table above
do not necessarily reflect the actual costs of the program.
General
and Administrative Expenses. General
and administrative expenses increased to $1.7 million for the three months
ended
September 30, 2006 compared to $1.5 million for the same period in 2005. This
increase reflects increased consulting costs and stock based compensation
expense partially offset by lower payroll costs as a result of the January
2006
restructuring. General and administrative expenses decreased to $4.7 million
for
the nine months ended September 30, 2006 from $5.0 million for the same period
in 2005. The decrease reflects lower payroll expenses as a result of the January
2006 restructuring and lower patent costs, offset partially by stock-based
compensation expense for general and administrative employees.
Restructure
Charges. Restructure
charges decreased to $413,000 for the three months ended September 30, 2006,
compared to $1.2 million for the same period in 2005. We recorded $221,000
in
additional charges during the three months ending September 30, 2006 due to
a
change in estimates regarding the lead time to find a sublessor at the Bothell
facility. In addition, there was $188,000 in accretion expense for the period.
This is lower than the prior year due to a $1.0 million charge resulting from
a
change in assumptions related to the terms of the Bothell lease in the third
quarter of 2005. Restructure charges increased to $1.8 million for the nine
months ended September 30, 2006, compared to $1.5 million for the same period
in
2005. Restructuring charges in the nine month periods include charges of
$860,000 in 2006 related to changes in our expectations regarding market
conditions for the Bothell facility subleasing market and $1.1 million in 2005
primarily related to a change in the assumptions related to the terms of the
Bothell sublease. Restructuring charges also include accretion expense of
$564,000 in the nine month period ended September 30, 2006 and $394,000 in
the
nine month period ended September 30, 2005. In January 2006, we recorded a
$221,000 charge related to the employee termination benefits of our
restructuring efforts to realign our resources to advance our lead inflammatory
arthritis product through clinical trials. In the second quarter of 2006, as
a
result of first quarter 2006 staff count reductions, we recorded additional
restructure charges of $173,000 to reflect a lease buyout for a portion of
our
Seattle facility lease.
13
Goodwill
impairment charge. As
discussed in Note 5 to the condensed consolidated financial statements, we
recognized a non-cash loss on impairment of goodwill during the nine month
period ended September 30, 2006. As a result of a decline in our share price
during June 2006, to a level which reduced market capitalization to an amount
less than the fair value of the Company’s net assets, we were required to
perform an interim goodwill impairment test. As a result of this evaluation
we
recognized a non-cash impairment charge of $23.7 million, which is equal to
the
recorded value of goodwill in excess of its implied value.
Other
Income and Expense
Investment
Income. Investment
income decreased to $147,000 for the three month period ended September 30,
2006
compared to $315,000 for the same period in 2005 due primarily to a realized
gain on investments of $142,000 from the receipt of shares of Chromos stock
in
the third quarter of 2005. These shares were consideration received for a
debenture that had been previously written down to zero. Investment income
increased to $468,000 for the nine month period ended September 30, 2006
compared to $382,000 for the same period in 2005 due to a non-cash charge of
$244,000 to record an other than temporary impairment in the carrying value
of
the Chromos securities in the second quarter of 2005. This loss is partially
offset by the $142,000 gain on investments discussed previously. Investment
income primarily reflects interest income earned on our short term
investments.
Interest
Expense. Interest
expense relates to interest on outstanding loans from our collaborative
partners, notes and obligations under equipment financing arrangements that
we
use to finance purchases of laboratory and computer equipment, furniture and
leasehold improvements. Interest expense decreased to $126,000 for the three
months ended September 30, 2006, compared to $135,000 for the same period in
2005. Interest expense decreased to $362,000 for the nine months ending
September 30, 2006 compared to $400,000 for the same period in 2005. The
decrease primarily reflects lower interest charges on decreased principal
amounts outstanding under our equipment financing arrangements and the Biogen
note.
Liquidity
and Capital Resources
We
had
cash and cash equivalents balances of $9.3 million as of September 30, 2006
compared to $14.1 million as of December 31, 2005. Our cash and cash equivalents
decreased in the nine months ending September 30, 2006 reflecting our cash
used
in operations of $9.5 million partially offset by the net proceeds of $4.8
million from our March 2006 sale of our common stock. Our shareholders’ equity
decreased to $1.5 million at September 30, 2006, compared to $30.6 million
at
December 31, 2005 primarily due to losses of $34.8 million for the nine months
ended September 30, 2006 including a goodwill impairment charge of $23.7 million
described above. As discussed in Note 7 to the condensed consolidated financial
statements, we expect to record a fourth quarter 2006 decrease in our
liabilities and increase to our shareholders’ equity balance as a result of
Biogen’s November 7, 2006 conversion of $5.65 million of debt to
equity.
In
March
2006, we sold 1,279,161 shares of our common stock in a registered offering
at a
price of $3.90 per share and received net proceeds of approximately $4.8
million. We intend to continue to seek appropriate opportunities to access
the
public and private capital markets, however, our ability to issue equity
securities at the current market price will likely be adversely affected by
the
fact that we are presently ineligible under SEC rules to utilize Form S-3 for
primary offerings of our securities because the aggregate market value of our
outstanding common stock held by non-affiliates is less than $75 million. This
ineligibility results in a longer length of time necessary to raise
capital.
Our
primary expenses are related to the development of our research and development
programs, the conduct of preclinical studies and clinical trials and general
and
administrative support for these activities. Our HIV/AIDS vaccine candidate
and
our inflammatory arthritis product candidate are both in clinical trials. We
expect to continue incurring significant expense in advancing our inflammatory
arthritis product candidate toward commercialization. As a result, we do not
expect to generate sustained positive cash flow from our operations for at
least
the next several years and only then if we can successfully develop and
commercialize our product candidates. We will require substantial additional
financial resources to fund the development and commercialization of our lead
product candidate in inflammatory arthritis.
14
Since
implementing a reduction in force in January 2006, we have focused our
development funding on our inflammatory arthritis product candidate, which
is in
clinical trials. During 2005, we spent approximately $2.4 million on this
program in outside costs and allocated staff costs to support research and
development activities and clinical trial costs, and we expect to spend
approximately $3 million in 2006 on this program, largely for clinical trial
expenses. We currently fund all costs of this program from our working capital
and expect to do so for the foreseeable future, although our strategy is to
ultimately seek a partner to fund later-stage development of this
program.
In
addition to the funding necessary to advance our product development and fund
our ongoing operating costs, we also have significant outstanding debt, lease
commitments and long-term obligations which draw on our cash resources. Our
most
significant obligation is approximately $13.6 million of remaining Bothell
facility lease payments which we are obligated to pay at $1.4 million to $1.6
million per year until the year 2015. On November 7, 2006, we signed an
agreement to restructure our $8.15 million loan payable to Biogen Idec. Under
the agreement, we converted $5.65 million of debt into one million shares of
common stock issued to Biogen Idec. At the time of signing we made a payment
of
$500,000 towards the remaining loan balance. The remaining $2.0 million
principal balance continues to bear interest at the rate of LIBOR plus 1% and
is
to be paid in two equal installments of $1.0 million each on August 1, 2007
and
2008. In addition, the agreement provides for early repayment of the 2007
installment within thirty days of a change in control of the Company. Several
of
the provisions of the modified loan agreement entered into in September 2005
continue including the requirement to apply one-third of certain up-front
payments received from potential future corporate collaborations to the
outstanding balance on this loan payable. We will need to raise additional
capital to perform planned research and development activities and make the
scheduled lease payments and to repay these notes.
We
expect
the level of our future operating expenses to be driven by the needs of our
product development programs, our debt obligations and our lease obligations
offset by the availability of funds through equity offerings, partner-funded
collaborations or other financing or business development activities. The size,
scope and pace of our product development activities depend on the availability
of these resources. Our future cash requirements will depend on many factors,
including:
• the
rate
and extent of scientific progress in our research and development programs;
• the
timing, costs and scope of, and our success in, conducting clinical trials,
obtaining regulatory approvals and pursuing patent prosecutions;
• competing
technological and market developments;
• the
timing and costs of, and our success in, any product commercialization
activities and facility expansions, if and as required; and
• the
existence and outcome of any litigation or administrative proceedings involving
intellectual property.
We
have
financed our product development activities and general corporate functions
primarily through proceeds from public and private sales of our equity
securities, through cash payments received from our collaborative partners
and
proceeds from the issuance of debt. To a lesser degree, we have also financed
our operations through interest earned on cash and cash equivalents, loan
funding under equipment financing agreements and research grants. These
financing sources have historically allowed us to maintain adequate levels
of
cash and cash equivalents.
Our
development collaborations have typically provided us with funding in several
forms, including purchases of our equity securities, loans, payments for
reimbursement of research and development costs and milestone fees and payments.
We and our partners typically agree on a target disease and create a development
plan for the product candidate, which subject to termination by the
collaborative partner, often extends for multiple years. For example, in the
second half of 2005 we extended the scope of our HIV/AIDS vaccine program via
a
collaboration between CHOP, CCRI and us under a contract awarded by the NIAID.
During the first nine months of 2006 we received $589,000 under this
collaboration and our portion of the funding could be up to an additional $17.6
million over the next four years.
The
funding from each of our collaborative partners fully offsets our incremental
program costs from each collaboration and also partially funds development
of
our inflammatory arthritis product candidate, overhead and fixed costs. Our
revenue from collaborative agreements totaled $6.9 million in 2005 and $9.7
million in 2004 and assuming that we complete all of the planned development
activities for each of these funded projects, we expect to earn revenue of
approximately $8 million in 2006.
15
Our
partners have the right to terminate our collaborations and their obligation
to
provide research funding at any time for any reason. For example, IAVI can
terminate our HIV/AIDS vaccine collaboration with 180 days notice. If we were
to
lose the collaborative funding expected from our IAVI collaboration or our
NIAID
collaboration with CHOP and CCRI and were unable to obtain alternative sources
of funding for the product candidate under development in that collaboration,
we
may be unable to continue our research and development program for that product
candidate.
Our
near-term financing strategy includes leveraging our development capabilities
and intellectual property assets into additional capital raising opportunities,
advancing our clinical development programs and accessing the public and private
capital markets at appropriate times. In addition, we intend to manage our
cash by focusing on advancing our inflammatory product candidate through
clinical testing. Our financing strategy is focused around the advancement
of
our two programs in clinical development, advancement of our newer development
collaborations and generating value out of our other intellectual assets and
capabilities. In the biotechnology industry there is a low level of success
in
clinical trials and our ability to raise capital depends in part on clinical
trial success.
We
are
currently evaluating additional sources of financing which could involve one
or
more of the following:
· |
entering
into additional product development
collaborations;
|
· |
mergers
and acquisitions;
|
· |
issuing
equity in the public or private markets;
|
· |
extending
or expanding our current
collaborations;
|
· |
selling
or licensing our technology or product candidates;
|
· |
borrowing
under loan or equipment financing arrangements;
or
|
· |
issuing
debt.
|
We
expect
that our total cash requirements, which consists of cash used in operations
plus
capital expenditures and payments of obligations, for 2006 will range from
$13
million to $15 million and that our cash and cash equivalents at September
30,
2006, plus the funding from our product development collaborations and contracts
will be sufficient to fund our operations into the first quarter of 2007.
This
estimate is based on our ability to perform planned research and development
activities and the receipt of planned funding from our collaborators.
Accordingly, we will need to raise additional funds in the near
term.
Additional
funding may not be available to us on reasonable terms, if at all. Our ability
to issue equity, and our ability to issue it at the current market price,
may be
adversely affected by the fact that we are presently ineligible under SEC
rules
to utilize Form S-3 for primary offerings of our securities because the
aggregate market value of our outstanding common stock held by non-affiliates
is
less than $75 million. In addition, our shareholders’ equity of $1.5 million as
of September 30, 2006 is lower than the minimum listing requirements of the
Nasdaq Capital Market. As a result of our November 7, 2006 debt restructuring
agreement with Biogen Idec, discussed in Note 7 to the condensed consolidated
financial statements, we expect to record a fourth quarter 2006 decrease
in our
liabilities and increase to our shareholders’ equity balance as a result of
Biogen’s conversion of $5.65 million of debt to equity. Notwithstanding this
restructuring of our debt to Biogen Idec, we may receive a letter from Nasdaq
notifying us that we were not in compliance with Nasdaq Marketplace Rule
4320(e)(2) at September 30, 2006 and Nasdaq may institute delisting proceedings.
A delisting would negatively impact our ability to raise additional funding.
Depending on our ability to successfully access additional funding, we may
be
forced to implement significant cost reduction measures. These adjustments
may
include scaling back, delaying or terminating one or more research and
development programs, curtailing capital expenditures or reducing other
operating activities. We may also be required to relinquish some rights to
our
technology or product candidates or grant licenses on unfavorable terms,
either
of which would reduce the ultimate value to us of the technology or product
candidates.
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
Items
with interest rate risk:
· Short
term investments:
Because
of the short-term nature of our investments, we believe that our exposure to
market rate fluctuations on our investments is minimal. Currently, we do not
use
any derivative or other financial instruments or derivative commodity
instruments to hedge any market risks and do not plan to employ these
instruments in the future. At September 30, 2006, we held $9.3 million in cash
and cash equivalents, which are primarily invested in money market funds and
denominated in U.S. dollars. An analysis of the impact on these securities
of a
hypothetical 10% change in short-term interest rates from those in effect at
September 30, 2006, indicates that such a change in interest rates would not
have a significant impact on our financial position or on our expected results
of operations in 2006.
16
· Notes
payable:
Our
results of operations are affected by changes in short-term interest rates
as a
result of a loan from Biogen which contains a variable interest rate. Interest
payments on this loan are established quarterly based upon the one-year London
Interbank Offered Rate, or LIBOR, plus 1%. As of September 30, 2006, we were
accruing interest on the note at a rate of 6.59%. The carrying amount of
the
note payable approximates fair value because the interest rate on this
instrument changes with, or approximates, market rates.
On
November 7, 2006, we signed an agreement to restructure $8.15 million of
debt
payable to Biogen Idec. Under the agreement, we settled $5.65 million of
debt
through the issuance of one million shares of common stock to Biogen Idec.
At
the time of signing we also made a payment of $500,000 towards the remaining
loan balance. The remaining $2.0 million principal balance continues to bear
interest at the rate of LIBOR plus 1% and is to be paid in two equal
installments of $1.0 million each on August 1, 2007 and 2008. The following
table provides information about our remaining debt obligations that are
sensitive to changes in interest rate fluctuations as adjusted to reflect
this
agreement which is described in Note 7 to the condensed consolidated financial
statements:
Expected
Maturity Date
|
|||||||||||||||||||
2006
|
2007
|
2008
|
2009
|
2010
|
Total
|
||||||||||||||
Variable
rate note
|
$
|
—
|
$
|
1,000,000
|
$
|
1,000,000
|
$
|
—
|
$
|
—
|
$
|
2,000,000
|
Items
with market and foreign currency exchange risk:
· Investment
in Chromos Molecular Systems, Inc.:
At
September 30, 2006, we held 2.5 million shares of Chromos Molecular Systems,
or
Chromos, common shares with a market value of $0.17 per common share denominated
in Canadian dollars. As of September 30, 2006 the Canadian to US exchange rate
was US $0.8979 per CA $1.00. As of September 30, 2006, our investment is
recorded at $375,000 with a $20,000 unrealized gain and is classified on our
Condensed Consolidated Balance Sheet within prepaid expenses and other. We
hold
these shares of common stock as available-for-sale securities as we periodically
sell them on the Toronto Stock Exchange. During the first 2 quarters of 2006
we
sold 280,000 shares of Chromos stock in 2006 and recorded $8,000 of net realized
gains and received $49,000 in cash. The amount of potential realizable value
in
this investment will be determined by the market, the exchange rate between
the
Canadian and US dollar and our ability to sell the shares.
Evaluation
of disclosure controls and procedures. Based
on
our management’s evaluation, with the participation of our Chief Executive
Officer and Chief Financial Officer, of the effectiveness of our disclosure
controls and procedures as of the end of the period covered by this quarterly
report, our Chief Executive Officer and Chief Financial Officer have concluded
that our disclosure controls and procedures are effective in ensuring that
information we are required to disclose in reports that we file or submit under
the Securities Exchange Act of 1934, as amended, is recorded, processed,
summarized and reported within the time periods specified in the Securities
and
Exchange Commission rules and forms.
Changes
in internal control over financial reporting. There
was
no change in our internal control over financial reporting, that occurred during
the period covered by this quarterly report that materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
None.
Item
1A. Risk Factors
Other
than with respect to the risk factors below, there have been no material changes
from the risk factors disclosed in “Section 1A. Risk Factors” of the Company’s
Annual Report on Form 10-K for the year ended December 31, 2005 as updated
in Section 1A of our Quarterly Reports on Form 10-Q for the quarters ended
March
31, 2006 and June 30, 2006. The risk factors below were disclosed those prior
filings and have been updated to provide more recent financial and factual
information as of September 30, 2006.
If
we are unable to raise additional capital when needed, we will be unable to
conduct our operations and develop our potential
products.
Because
internally generated cash flow will not fund development and commercialization
of our product candidates, we will require substantial additional financial
resources. Our future capital requirements will depend on many factors,
including:
17
· |
the
rate and extent of scientific progress in our research and development
programs;
|
· |
the
timing, costs and scope of, and our success in, conducting clinical
trials, obtaining regulatory approvals and pursuing patent
prosecutions;
|
· |
competing
technological and market developments;
|
· |
the
timing and costs of, and our success in, any product commercialization
activities and facility expansions, if and as required;
and
|
· |
the
existence and outcome of any litigation or administrative proceedings
involving intellectual property.
|
We
expect that our cash and cash equivalents at September 30, 2006, plus the
funding from our partners will be sufficient to fund our operations into the
first quarter of 2007. This estimate is based on our ability to perform planned
research and development activities and the receipt of planned funding from
our
collaborators. Accordingly, we will need to raise additional funding in the
near
term. In addition, as of November 7, 2006 we owe to Biogen Idec approximately
$2.0 million in aggregate principal amount. The terms of the note requires
us to
make annual interest payments and scheduled principal payments of $1.0 million
in each of August 2007 and 2008. We will need to raise additional capital to
perform planned research and development activities and make these scheduled
payments. Additional sources of financing could involve one or more of the
following:
· |
entering
into additional product development
collaborations;
|
· |
mergers
and acquisitions;
|
· |
issuing
equity in the public or private markets;
|
· |
extending
or expanding our current
collaborations;
|
· |
selling
or licensing our technology or product candidates;
|
· |
borrowing
under loan or equipment financing arrangements; or
|
· |
issuing
debt.
|
Additional
funding may not be available to us on reasonable terms, if at all. Our ability
to issue equity, and our ability to issue it at the current market price, may
be
adversely affected by the fact that we are presently ineligible under SEC rules
to utilize Form S-3 for primary offerings of our securities because the
aggregate market value our outstanding common stock held by non-affiliates
is
less than $75 million.
The
perceived risk associated with the possible sale of a large number of shares
could cause some of our stockholders to sell their stock, thus causing the
price
of our stock to decline. In addition, actual or anticipated downward pressure
on
our stock price due to actual or anticipated sales of stock could cause some
institutions or individuals to engage in short sales of our common stock, which
may itself cause the price of our stock to decline.
If
our
stock price declines, we may be unable to raise additional capital. A sustained
inability to raise capital could force us to go out of business. Significant
declines in the price of our common stock could also impair our ability to
attract and retain qualified employees, reduce the liquidity of our common
stock
and result in the delisting of our common stock from the NASDAQ Capital
Market.
The funding that we expect to receive from our collaborations depends on
continued scientific progress under the collaboration and our collaborators’
ability and willingness to continue or extend the collaboration. If we are
unable to successfully access additional capital, we may need to scale back,
delay or terminate one or more of our development programs, curtail capital
expenditures or reduce other operating activities. We may also be required
to
relinquish some rights to our technology or product candidates or grant or
take
licenses on unfavorable terms, either of which would reduce the ultimate value
to us of our technology or product candidates.
18
We
expect to continue to operate at a loss and may never become
profitable.
Substantially all of our revenue has been derived under collaborative research
and development agreements relating to the development of our potential product
candidates. We have incurred, and will continue to incur for the foreseeable
future, significant expense to develop our research and development programs,
conduct preclinical studies and clinical trials, seek regulatory approval for
our product candidates and provide general and administrative support for these
activities. As a result, we have incurred significant net losses since
inception, and we expect to continue to incur substantial additional losses
in
the future. As
of
September 30, 2006, we had an accumulated deficit of $284.8 million. We may
never generate profits and, if we do become profitable, we may be unable to
sustain or increase profitability.
All
of our product candidates are in early-stage clinical trials or preclinical
development, and if we are unable to successfully develop and commercialize
our
product candidates we will be unable to generate sufficient capital to maintain
our business.
In
November 2005, IAVI initiated a Phase II trial for our HIV/AIDS vaccine
product candidate in South Africa. In March 2006, we initiated a Phase I/II
trial for our inflammatory arthritis product candidate in the United States
and
Canada. We will not generate any product revenue for at least several years
and
then only if we can successfully develop and commercialize our product
candidates. Commercializing our potential products depends on successful
completion of additional research and development and testing, in both
preclinical development and clinical trials. Clinical trials may take several
years or more to complete. The commencement, cost and rate of completion of
our
clinical trials may vary or be delayed for many reasons, including the risks
discussed elsewhere in this section. If we are unable to successfully complete
preclinical and clinical development of some or all of our product candidates
in
a timely manner, we may be unable to generate sufficient product revenue to
maintain our business.
Even if our potential products succeed in clinical trials and are approved
for
marketing, these products may never achieve market acceptance. If we are
unsuccessful in commercializing our product candidates for any reason, including
greater effectiveness or economic feasibility of competing products or
treatments, the failure of the medical community or the public to accept or
use
any products based on gene delivery, inadequate marketing and distribution
capabilities or other reasons discussed elsewhere in this section, we will
be
unable to generate sufficient product revenue to maintain our business.
If
we lose our collaborative partners, we may be unable to develop our potential
products.
A portion of our operating expenses are funded through our collaborative
agreements with third parties. We currently have strategic partnerships with
two
biotechnology companies, Sirna Therapeutics and Celladon, one public health
organization, IAVI, and through a contract with a U.S. government agency, NIAID,
that provide for funding, collaborative development, intellectual property
rights or expertise to develop certain of our product candidates. With limited
exceptions, each collaborator has the right to terminate its obligation to
provide research funding at any time for scientific or business reasons. In
addition, to the extent that funding is provided by a collaborator for
non-program-specific uses, the loss of significant amounts of collaborative
funding could
result in the delay, reduction or termination of additional research and
development programs, a reduction in capital expenditures or business
development and other operating activities, or any combination of these
measures. For example, we have a collaboration and license agreement with
Celladon which may be terminated at will by Celladon subject to a notice
provision in the agreement. We expect Celladon to provide us with funding to
reimburse research and development and manufacturing expenses that we incur
in
connection with the collaboration.
A
decline in our stock price or decline in our shareholders’ equity could cause
our common stock to be delisted from the NASDAQ Capital Market and the liquidity
and the market price of our common stock to
decline.
Our
stock is listed on the NASDAQ Capital Market. In order to continue to be listed
on the NASDAQ Capital Market, we must meet specific quantitative standards,
including maintaining a minimum bid price of $1.00 for our common stock. On
May
31, 2005, we received a notice from the NASDAQ Stock Market informing us that
for 30 consecutive business days the bid price of our common stock had closed
below the minimum $1.00 per share requirement for continued inclusion under
Marketplace Rule 4310(c)(4). The letter stated that under Marketplace Rule
4310(c)(8)(d), we were provided with 180 calendar days, or until November 28,
2005, to regain compliance with Marketplace Rule 4310(c)(4). As of November
28,
2005, we had not regained compliance with Market place Rule 4310(c). However,
since we met all of the NASDAQ Stock Market’s criteria set forth in Marketplace
Rule 4310(c), except for the bid price requirement, the NASDAQ provided us
with
an additional 180 calendar day compliance period, or until May 26, 2006, to
demonstrate full compliance and maintain our listing on the NASDAQ Capital
Market.
19
On May 8, 2006, our board of directors approved an amendment to our
articles of incorporation to reduce our number of authorized shares of common
stock from 180,000,000 to 18,000,000 and also approved a one-for-ten reverse
stock split of our common stock. The reverse stock split was effective with
respect to shareholders of record at the close of trading on May 10, 2006,
and
our common stock began trading on a split-adjusted basis on May 11, 2006.
On May 25, 2006, we received notification from the Nasdaq Listing Qualifications
Staff that we had regained compliance with Marketplace Rule 4310(c)(4) and
that the Staff would give this matter no further consideration. There can be
no
assurance that we will continue to meet the $1.00 minimum bid requirement.
As
of
September 30, 2006, our shareholders’ equity was $1.5 million. The
minimum continued listing requirement for the Nasdaq Capital Market is
$2.5 million. We have incurred significant net losses since our inception
and may incur additional losses in the future. When a company’s shareholders’
equity decreases below $2.5 million, they will be notified by the Nasdaq
Listing Qualifications Department that they are not in compliance with the
minimum $2.5 million shareholders’ equity requirement of Nasdaq Marketplace
Rule 4320(e)(2). On November 7, 2006, we and Biogen Idec entered into an
agreement to settle a portion of our remaining outstanding debt to Biogen
Idec.
As a result of this transaction we expect our shareholders’ equity will increase
by approximately $5.5 million. Notwithstanding
the restructuring of our debt to Biogen Idec, we may receive a letter from
Nasdaq notifying us that we were not in compliance with Nasdaq Marketplace
Rule
4320(e)(2) at September 30, 2006 and Nasdaq may institute delisting
proceedings.
If
we
were delisted from the NASDAQ Capital Market, trading, if any, in our shares
may
continue to be conducted on the OTC Bulletin Board or in a non-NASDAQ
over-the-counter market, such as the “pink sheets.” Delisting of our shares
would result in limited release of the market price of those shares and limited
analyst coverage and could restrict investors’ interest in our securities. Also,
a delisting could have a material adverse effect on the trading market and
prices for our shares and our ability to issue additional securities or to
secure additional financing. In addition, if our shares were not listed and
the
trading price of our shares was less than $5 per share, our shares could be
subject to Rule 15g-9 under the Securities Exchange Act of 1934 which, among
other things, requires that broker/dealers satisfy special sales practice
requirements, including making individualized written suitability determinations
and receiving a purchaser’s written consent prior to any transaction. In such
case, our securities could also be deemed to be a “penny stock” under the
Securities Enforcement and Penny Stock Reform Act of 1990, which would require
additional disclosure in connection with trades in those shares, including
the
delivery of a disclosure schedule explaining the nature and risks of the penny
stock market. Such requirements could severely limit the liquidity of our
securities.
Item
2. Unregistered Sales of Securities and Use of
Proceeds
Certain
of our loan agreements contain financial covenants establishing limits on our
ability to declare or pay cash dividends.
None.
None.
None.
See the Index to Exhibits included in this quarterly report.
20
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
TARGETED GENETICS CORPORATION | ||
|
|
|
Date: November 9, 2006 | By: | /s/ H. STEWART PARKER |
H. Stewart Parker,
President, Chief Executive Officer and Director
(Principal
Executive Officer)
|
||
|
|
|
Date: November 9, 2006 | By: | /s/ DAVID J. POSTON |
David J. Poston,
Vice President and Chief Financial
Officer
(Principal
Financial and Accounting
Officer)
|
||
21
INDEX
TO EXHIBITS
Incorporated
by Reference
|
||||||||||||||||
Exhibit No.
|
Exhibit
Description
|
Form
|
Date
|
Number
|
Filed
Herewith
|
|||||||||||
3.1
|
Amended and Restated Articles of Incorporation |
8-K
|
05/26/2005
|
3.1
|
||||||||||||
3.2
|
Amended and Restated Bylaws |
10-K
|
12/31/1996
|
3.2
|
||||||||||||
10.1
|
Change of Control Agreement dated September 14, 2006 between Targeted Genetics Corporation and David J. Poston |
8-K
|
9/14/2006
|
10.1
|
||||||||||||
10.2
|
Amendment No. 3 to Funding Agreement dated November 7, 2006 between Targeted Genetics Corporation and Biogen Idec MA Inc. |
8-K
|
11/7/2006
|
10.1
|
||||||||||||
10.3
|
Amended and Restated Promissory Note issued by Targeted Genetics Corporation to Biogen Idec MA Inc. dated November 7, 2006 |
8-K
|
11/7/2006
|
10.2
|
||||||||||||
31.1
|
Certification of Chief Executive Officer pursuant to Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended |
X
|
||||||||||||||
31.2
|
Certification of Chief Financial Officer pursuant to Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended |
X
|
||||||||||||||
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 |
X
|
||||||||||||||
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 |
X
|
||||||||||||||
22