Armata Pharmaceuticals, Inc. - Quarter Report: 2006 June (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 JUNE 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 x 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 August 8, 2006:
9,896,898
TARGETED
GENETICS CORPORATION
Quarterly
Report on Form 10-Q
For
the
quarter ended June 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 June 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 six months
ended
June 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 six months ended
June 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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16
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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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21
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Item
6.
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Exhibits
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21
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SIGNATURES
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22
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EXHIBIT
INDEX
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23
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i
PART
I FINANCIAL INFORMATION
Item
1. Financial
Statements
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
June
30, 2006 |
December
31, 2005 |
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
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12,171,000
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$
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14,122,000
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|||
Accounts
receivable
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290,000
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380,000
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|||||
Prepaid
expenses and other
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946,000
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683,000
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|||||
Total
current assets
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13,407,000
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15,185,000
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|||||
Property
and equipment, net
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1,440,000
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1,747,000
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|||||
Goodwill
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7,926,000
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31,649,000
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|||||
Other
assets
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212,000
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217,000
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|||||
Total
assets
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$
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22,985,000
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$
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48,798,000
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|||
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
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$
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2,173,000
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$
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1,770,000
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|||
Accrued
employee expenses
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569,000
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587,000
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|||||
Accrued
restructure charges
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1,051,000
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1,838,000
|
|||||
Deferred
revenue
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143,000
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278,000
|
|||||
Current
portion of long-term obligations
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65,000
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155,000
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|||||
Total
current liabilities
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4,001,000
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4,628,000
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|||||
Accrued
restructure charges and deferred rent
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6,446,000
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5,422,000
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|||||
Long-term
obligations
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8,156,000
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8,177,000
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|||||
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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—
|
|||||
Common
stock, $0.01 par value, 18,000,000 shares authorized, 9,871,898 shares
issued and outstanding at June 30, 2006 and 8,569,424 shares issued
and
outstanding at December 31, 2005
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99,000
|
857,000
|
|||||
Additional
paid-in capital
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285,888,000
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279,772,000
|
|||||
Accumulated
deficit
|
(281,645,000
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)
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(250,037,000
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)
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|||
Accumulated
other comprehensive income (loss)
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40,000
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(21,000
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)
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||||
Total
shareholders’ equity
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4,382,000
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30,571,000
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|||||
Total
liabilities and shareholders’ equity
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$
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22,985,000
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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
June
30,
|
Six
months ended
June
30,
|
||||||||||||
2006
|
2005
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2006
|
2005
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||||||||||
Revenue
under collaborative agreements
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$
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1,414,000
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$
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1,462,000
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$
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3,844,000
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$
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3,462,000
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|||||
Operating
expenses:
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|||||||||||||
Research
and development
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3,683,000
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4,808,000
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7,360,000
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9,347,000
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|||||||||
General
and administrative
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1,568,000
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1,660,000
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3,049,000
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3,545,000
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|||||||||
Restructure
charges
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363,000
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119,000
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1,405,000
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338,000
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|||||||||
Goodwill
impairment charge
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23,723,000
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—
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23,723,000
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—
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|||||||||
Total
operating expenses
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29,337,000
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6,587,000
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35,537,000
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13,230,000
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|||||||||
Loss
from operations
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(27,923,000
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)
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(5,125,000
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)
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(31,693,000
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)
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(9,768,000
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)
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|||||
Investment
income (loss)
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170,000
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(33,000
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)
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321,000
|
67,000
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||||||||
Interest
expense
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(123,000
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)
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(136,000
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)
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(236,000
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)
|
(265,000
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)
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|||||
Net
loss
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$
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(27,876,000
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)
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$
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(5,294,000
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)
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$
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(31,608,000
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)
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$
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(9,966,000
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)
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Net
loss per common share (basic and diluted)
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$
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(2.83
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)
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$
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(0.62
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)
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$
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(3.37
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)
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$
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(1.16
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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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9,854,000
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8,563,000
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9,371,000
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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)
Six
months ended
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|||||||
June
30,
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|||||||
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2006
|
2005
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|||||
Operating
activities:
|
|||||||
Net
loss
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$
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(31,608,000
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)
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$
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(9,966,000
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)
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Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
364,000
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647,000
|
|||||
Stock-based
compensation
|
464,000
|
—
|
|||||
Stock
issued to outside vendors
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86,000
|
—
|
|||||
Goodwill
impairment charge
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23,723,000
|
—
|
|||||
Loss
(gain) on investments
|
(8,000
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)
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278,000
|
||||
Changes
in assets and liabilities:
|
|||||||
Decrease
in accounts receivable
|
90,000
|
280,000
|
|||||
Increase
in prepaid expenses and other
|
(243,000
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)
|
(291,000
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)
|
|||
Decrease
in other assets
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5,000
|
467,000
|
|||||
Increase
in current liabilities
|
385,000
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595,000
|
|||||
Increase
(decrease) in deferred revenue
|
(135,000
|
)
|
143,000
|
||||
Increase
in accrued restructure expenses and deferred rent
|
237,000
|
5,000
|
|||||
Net
cash used in operating activities
|
(6,640,000
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)
|
(7,842,000
|
)
|
|||
Investing
activities:
|
|||||||
Purchases
of property and equipment
|
(57,000
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)
|
(302,000
|
)
|
|||
Proceeds
from sale of investments
|
49,000
|
29,000
|
|||||
Net
cash used in investing activities
|
(8,000
|
)
|
(273,000
|
)
|
|||
Financing
activities:
|
|||||||
Net
proceeds from sales of common stock
|
4,808,000
|
6,000
|
|||||
Payments
under leasehold improvements and equipment financing
arrangements
|
(111,000
|
)
|
(378,000
|
)
|
|||
Net
cash provided by (used in) financing activities
|
4,697,000
|
(372,000
|
)
|
||||
Net
decrease in cash and cash equivalents
|
(1,951,000
|
)
|
(8,487,000
|
)
|
|||
Cash
and cash equivalents, beginning of period
|
14,122,000
|
34,096,000
|
|||||
Cash
and cash equivalents, end of period
|
$
|
12,171,000
|
$
|
25,609,000
|
|||
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. 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 six months ended June
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 $12.2 million at June 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:
June
30, 2006 |
December
31, 2005 |
||||||
Loans
payable to Biogen Idec
|
$
|
8,150,000
|
$
|
8,150,000
|
|||
Equipment
financing obligations
|
71,000
|
182,000
|
|||||
Total
obligations
|
8,221,000
|
8,332,000
|
|||||
Less
current portion
|
(65,000
|
)
|
(155,000
|
)
|
|||
Total
long-term obligations
|
$
|
8,156,000
|
$
|
8,177,000
|
We
have
two loans payable to Biogen Idec, a beneficial owner of approximately 11.9%
of
our outstanding common shares. As of June 30, 2006 we have $7.5 million of
principle remaining on a $10.0 million note payable. 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 payments of $2.5 million of principal amount
plus accrued interest are due on each of August 1, 2007, 2008 and 2009. 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 on the principal being repaid, and second to the repayment of
outstanding principal in reverse order of maturity. The second loan is a
promissory note payable to Biogen Idec which we assumed in 2000 as part of
our
acquisition of Genovo. This promissory note has an outstanding principal amount
of $650,000, bears no interest and matures in August 2007.
Future
aggregate principal payments related to long-term obligations are $44,000 for
the remainder of 2006, $3,176,000 in 2007, $2,501,000 in 2008, $2,500,000 in
2009 and zero in 2010.
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 consolidated
statements of operations.
The
table
below presents a reconciliation of the accrued restructure liability for the
six
month period ended June 30, 2006:
Contract
Termination Costs
|
Employee
Termination Benefits
|
Total
|
||||||||
December
31, 2005 accrued liability
|
$
|
7,149,000
|
$
|
—
|
$
|
7,149,000
|
||||
Charges
incurred
|
811,000
|
219,000
|
1,030,000
|
|||||||
Adjustments
to the liability (accretion)
|
375,000
|
—
|
375,000
|
|||||||
Amount
paid
|
(849,000
|
)
|
(219,000
|
)
|
(1,068,000
|
)
|
||||
June
30, 2006 accrued liability
|
$
|
7,486,000
|
$
|
—
|
$
|
7,486,000
|
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. Adjustments to the accrued restructure liability for the six months
ended June 30, 2006 reflect $375,000 of accretion expense for the period. 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 $219,000 of restructuring expenses 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.
We do not anticipate any additional charges related to this
restructuring.
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. This modification
was entered into as a result of the reduction of our workforce. Expenses related
to the termination of the lease totaling $172,000 are included in restructuring
charges for the three and six months ending June 30, 2006.
Through
June 30, 2006, we have recorded contract termination costs totaling $9.4 million
for our Bothell facility. We expect to incur an additional $3.2 million in
accretion expense 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 (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, the Company granted options
to
purchase an aggregate of 306,500 shares of common stock with an accelerated
twelve month vesting period. A total of 198,000 of these options to purchase
shares of common stock were granted 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 $243,000 of stock-based compensation expense
in the second quarter of 2006 and $464,000 for the six months ending June 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 June 30, 2006, we classified $137,000 of the stock-based
compensation expense as research and development expense and $106,000 as general
and administrative expense. For the six months ended June 30, 2006 we classified
$262,000 as research and development expense and $202,000 as general and
administrative expense. As of June 30, 2006, total unrecognized compensation
cost related to unvested options was approximately $1.1 million, net of
estimated forfeitures, which we expect to recognize over a weighted average
period of approximately 11.5 months.
6
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 six months ended June 30, 2005:
Three
months ended
June
30, 2005
|
Six
months ended
June
30, 2005
|
||||||
Net
loss:
|
|||||||
As
reported
|
$
|
(5,294,000
|
)
|
$
|
(9,966,000
|
)
|
|
Pro
forma stock-based compensation expense
|
(404,000
|
)
|
(868,000
|
)
|
|||
Pro
forma
|
$
|
(5,698,000
|
)
|
$
|
(10,834,000
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||
As
reported
|
$
|
(0.62
|
)
|
$
|
(1.16
|
)
|
|
Pro
forma
|
(0.67
|
)
|
(1.27
|
)
|
The
following is a summary of our stock option activity and related prices for
the
first six months of 2006:
Shares
|
Weighted
Average
Exercise
Price
|
||||||
Balance,
December 31, 2005
|
704,071
|
$
|
20.85
|
||||
Granted
|
332,200
|
3.34
|
|||||
Exercised
|
(3,350
|
)
|
3.44
|
||||
Forfeited
|
(101,442
|
)
|
17.10
|
||||
Balance,
June 30, 2006
|
931,479
|
15.08
|
The
weighted average fair value of stock options granted during the six months
ending June 30, 2006 was $1.85 and was $6.89 for the six months ending June
30,
2005. The weighted average remaining contractual term of options currently
exercisable as of June 30, 2006 is 5.73 years and was 5.99 years for options
exercisable at June 30, 2005. We received $11,500 from the exercise of stock
options for the six months ending June 30, 2006.
Stock
options outstanding and exercisable as of June 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
|
|||||||||||
$2.30
- $2.90
|
135,054
|
$
|
2.55
|
9.43
|
29,404
|
$
|
2.78
|
|||||||||
3.80
|
214,500
|
3.80
|
9.95
|
—
|
—
|
|||||||||||
4.30
- 12.20
|
194,348
|
7.94
|
7.75
|
107,569
|
7.61
|
|||||||||||
12.60
- 15.60
|
195,200
|
13.33
|
7.55
|
112,372
|
13.47
|
|||||||||||
15.90
- 148.80
|
192,377
|
45.45
|
3.93
|
188,296
|
45.91
|
|||||||||||
Balance,
June 30, 2006
|
931,479
|
15.08
|
7.67
|
437,641
|
25.27
|
The
total
intrinsic value of stock options is summarized as follows:
Number
of
Option
Shares
|
Aggregate
Intrinsic
Value
|
||||||
Options
outstanding at June 30, 2006
|
931,479
|
$
|
—
|
||||
Options
exercisable at June 30, 2006
|
437,641
|
—
|
|||||
Options
exercised during the six months ended June 30, 2006
|
3,350
|
3,199
|
7
The
aggregate intrinsic value is determined using the closing price of our common
stock on June 30, 2006 of $2.30 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:
Six
Months ended June 30,
|
|||||||
2006
|
2005
|
||||||
Expected
dividend rate
|
Nil
|
Nil
|
|||||
Expected
stock price volatility range
|
1.086-1.107
|
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 six months
ended June 30, 2006:
December
31, 2005 goodwill balance
|
$
|
31,649,000
|
||
Impairment
charge
|
(23,723,000
|
)
|
||
June
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
June
30,
|
Six
months ended
June
30,
|
||||||||||||
|
2006
|
2005
|
2006
|
2005
|
|||||||||
Net
loss as reported
|
$
|
(27,876,000
|
)
|
$
|
(5,294,000
|
)
|
$
|
(31,608,000
|
)
|
$
|
(9,966,000
|
)
|
|
Other
comprehensive loss:
|
|||||||||||||
Unrealized
gain on available-for-sale securities
|
—
|
—
|
48,000
|
—
|
|||||||||
Foreign
currency translation adjustment
|
15,000
|
—
|
13,000
|
—
|
|||||||||
Other
comprehensive loss
|
$
|
(27,861,000
|
)
|
$
|
(5,294,000
|
)
|
$
|
(31,547,000
|
)
|
$
|
(9,966,000
|
)
|
8
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
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.
We
are
primarily focused on the following product development programs:
Description
|
Indication
|
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
|
9
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 (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
June
2006, we entered into a collaboration and license agreement with IAVI, the
Columbus Children’s Research Institute (CCRI) and The Children’s Hospital of
Philadelphia (CHOP) in support of the development and commercialization of
HIV/AIDS vaccines. The new agreement supersedes our previous collaboration
agreement with IAVI and CCRI and addresses development and commercialization
issues consistent with the significant progress made in the HIV/AIDS vaccine
development program. Under this new agreement, we expect to continue to receive
funding from IAVI for the continued development of HIV/AIDS vaccines for the
developing world. We also received the rights to utilize the findings from
the
IAVI funded program to develop and commercialize HIV/AIDS vaccines for both
the
developed world and for any additional vaccine candidates. Among other rights
granted under this agreement, IAVI retains the exclusive rights for
commercialization in the developing world of any HIV/AIDS vaccine that is
developed under the collaboration, and will receive a royalty on income received
by us from the development and commercialization of vaccines. Also, on July
10,
2006, in connection with entering into this agreement we issued IAVI 25,000
shares of our common stock.
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 recognition of a loss
on
impairment of goodwill in the amount of $23.7 million. This non-cash charge
results 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
primary expenses are related 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
June 30, 2006, our accumulated deficit totaled $281.6 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.
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.
10
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 June 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 the interim goodwill impairment test, we recognized a non-cash loss
on
impairment of goodwill during the three month period ended June 30, 2006 of
$23.7 million based on an assessment that the implied value of goodwill was
$7.9
million at June 30, 2006.
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.
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.
11
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 $243,000 of expense for stock-based compensation for the three
months ending June 30, 2006 and $464,000 for the six months ending June 30,
2006. This expense is classified as follows:
Three
months ended June 30,
2006
|
Six
months ended June 30,
2006
|
||||||
Research
and development
|
$
|
(137,000
|
)
|
$
|
(262,000
|
)
|
|
General
and administrative
|
(106,000
|
)
|
(202,000
|
)
|
|||
Total
stock-based compensation
|
$
|
(243,000
|
)
|
$
|
(464,000
|
)
|
The
proforma cost of stock options compensation for the three months ended June
30,
2005 was $404,000 and the proforma cost of stock option compensation for the
six
months ending June 30, 2005 was $868,000 for which no expense was recorded
as
allowed under the provisions of APB Opinion No. 25. As of June 30, 2006, total
unrecognized compensation cost related to unvested options was approximately
$1.1 million, net of estimated forfeitures, which we expect to recognize over
a
weighted average period of approximately 11.5 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 June 30, 2006 was $1.4 million, which was reasonably
consistent compared to the same period in 2005. Revenue increased to $3.8
million for the six months ended June 30, 2006 compared to $3.5 million for
the
same period in 2005. The increase in revenue reflects higher research and
development activities under our collaboration with Celladon and our recently
initiated research and development activities under the National Institute
of
Allergy and Infectious Disease (NIAID) contract, 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 and IAVI
and the contract with the NIAID. For
the
next several years, our revenue will depend on the continuation of the current
collaborations and our success with entering into and then performing under
new
collaborations.
Operating
Expenses
Research
and Development Expenses. Research
and development expenses decreased to $3.7 million for the three months ended
June 30, 2006 compared to $4.8 million for the same period in 2005. This
decrease reflects lower preclinical costs incurred as a result of the January
2006 restructuring partially offset by higher expenses in support of our
inflammatory arthritis program and the recognition of stock option expense.
Research and development expense decreased to $7.4 million for the six months
ended June 30, 2006 compared to $9.3 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.
12
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
June
30,
|
Six
months ended
June
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Programs
in clinical development:
|
|||||||||||||
HIV/AIDS
vaccine
|
$
|
794,000
|
$
|
864,000
|
$
|
1,111,000
|
$
|
1,988,000
|
|||||
Inflammatory
arthritis
|
875,000
|
581,000
|
1,433,000
|
1,167,000
|
|||||||||
Cystic
fibrosis (1)
|
17,000
|
85,000
|
35,000
|
274,000
|
|||||||||
Indirect
costs
|
1,263,000
|
1,099,000
|
1,592,000
|
2,610,000
|
|||||||||
Total
clinical development program expense
|
2,949,000
|
2,629,000
|
4,171,000
|
6,039,000
|
|||||||||
Research
and preclinical development program expense
|
734,000
|
2,179,000
|
3,189,000
|
3,308,000
|
|||||||||
Total
research and development expense
|
$
|
3,683,000
|
$
|
4,808,000
|
$
|
7,360,000
|
$
|
9,347,000
|
(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 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 decreased to $1.6 million for the three months
ended
June 30, 2006 from $1.7 million for the same period in 2005. General and
administrative expenses decreased to $3.0 million for the six months ended
June
30, 2006 from $3.5 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 increased to $363,000 for the three months ended June 30, 2006, compared
to $119,000 for the same period in 2005. Restructure charges increased to $1.4
million for the six months ended June 30, 2006, compared to $338,000 for the
same period in 2005. Restructuring charges in the six month periods include
charges of $639,000 in 2006 and $100,000 in 2005 related to changes in our
expectations regarding market conditions for the Bothell facility subleasing
market. Restructuring charges also include accretion expense of $375,000 in
the
six month period ended June 30, 2006 and $237,000 in the six month period ended
June 30, 2005. In January 2006, we recorded a $219,000 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 we recorded $172,000 in relation to the
early termination of a portion of our Seattle facility lease resulting from
our
earlier head count reductions.
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 three month
period ended June 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.
13
Other
Income and Expense
Investment
Income. Investment
income increased to $170,000 for the three month period ended June 30, 2006
compared to a loss of $33,000 for the same period in 2005. Investment income
increased to $321,000 for the six month period ended June 30, 2006 compared
to
$67,000 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. 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 $123,000 for the three
months ended June 30, 2006, compared to $136,000 for the same period in 2005.
Interest expense decreased to $236,000 for the six months ending June 30, 2006
compared to $265,000 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 $12.2 million as of June 30, 2006 compared
to $14.1 million as of December 31, 2005. Our cash and cash equivalents
decreased in the six months ending June 30, 2006 reflecting our cash used in
operations of $6.6 million is partially offset by the proceeds of $4.8 million
from our March 2006 sale of 1.3 million shares of our common stock. Our
shareholders’ equity decreased to $4.4 million at June 30, 2006, compared to
$30.6 million at December 31, 2005 primarily due to our net loss of $31.6
million for the six months ended June 30, 2006 including a goodwill impairment
charge of $23.7 million.
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.
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 obligations are approximately $14.0 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 and $8.2 million of long-term debt to
Biogen Idec. Under our modified loan agreements with Biogen Idec, we are
obligated to make annual interest payments and scheduled payments of $3.2
million of principal plus accrued interest on August 1, 2007 and $2.5 million
of
principal plus accrued interest on August 1, 2008 and August 1, 2009. 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 on the principal being repaid, and second to the repayment of
outstanding principal in reverse order of maturity. We will need to raise
additional capital to make the scheduled 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:
14
· |
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.
Our portion of the funding for this new collaboration could be up to $18 million
over the next five 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
up to
approximately $9 million in 2006.
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, our NIAID
collaboration with CHOP and CCRI or our Celladon collaboration 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:
· |
issuing
equity in the public or private markets;
|
· |
extending
or expanding our current
collaborations;
|
· |
entering
into additional product development
collaborations;
|
· |
selling
or licensing our technology or product
candidates;
|
· |
mergers
and acquisitions;
|
· |
borrowing
under loan or equipment financing arrangements; or
|
15
· |
issuing
debt.
|
We
expect
that our total cash requirements for 2006 will range from $13
million to $16 million and that our cash and cash equivalents at June 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.
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. 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 June 30, 2006, we held $12.2 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
June 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.
· 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 June 30, 2006, we were accruing
interest on the note at a rate of 6.42%. The carrying amount of the note payable
approximates fair value because the interest rate on this instrument changes
with, or approximates, market rates. The following table provides information
as
of June 30, 2006, about our obligations that are sensitive to changes in
interest rate fluctuations:
Expected
Maturity Date
|
|||||||||||||||||||
2006
|
2007
|
2008
|
2009
|
2010
|
Total
|
||||||||||||||
Variable
rate note
|
$
|
—
|
$
|
2,500,000
|
$
|
2,500,000
|
$
|
2,500,000
|
$
|
—
|
$
|
7,500,000
|
Items
with market and foreign currency exchange risk:
· Investment
in Chromos Molecular Systems, Inc.:
At June
30, 2006, we held 2.5 million shares of Chromos Molecular Systems, or Chromos,
common shares with a market value of $0.18 per common share denominated in
Canadian dollars. As of June 30, 2006 the Canadian to US exchange rate was
US
$0.8931 per CA $1.00. As of June 30, 2006, our investment is recorded at
$395,000 with a $40,000 unrealized gain and is classified 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. As a
result of selling 280,000 shares of Chromos stock in 2006, we have 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.
16
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 Report on Form 10-Q for the quarter ended March
31, 2006. The risk factors below were disclosed on the Form 10-K and have been
updated to provide more recent financial and factual information as of June
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:
·
|
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 June 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. In addition, we owe approximately $8.2 million in aggregate
principal amount under two notes payable to Biogen Idec. The terms of the notes
require us to make annual interest payments and scheduled principal payments
of
$3.2 million in August 2007 and $2.5 million in each of August 2008 and 2009.
We
will need to raise additional capital to make the scheduled payments and to
repay these notes. Additional sources of financing could involve one or more
of
the following:
·
|
issuing
equity in the public or private markets;
|
·
|
extending
or expanding our current
collaborations;
|
·
|
entering
into additional product development
collaborations;
|
·
|
selling
or licensing our technology or product candidates;
|
·
|
mergers
and acquisitions;
|
·
|
borrowing
under loan or equipment financing arrangements; or
|
·
|
issuing
debt.
|
17
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.
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 June 30, 2006, we had an accumulated deficit of
$281.6 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 IAVI
which may be terminated at will by IAVI subject to a notice provision in the
agreement. We expect IAVI to provide us with funding to reimburse research
and
development and manufacturing expenses that we incur in connection with the
collaboration. As a result, a significant portion of our operating expenses
are
funded through our collaborative agreements with IAVI. Additionally, IAVI
directly funds the Phase II clinical trial for our HIV/AIDS vaccine product
candidate.
18
A
continued decline in our stock price or decline in our shareholders’ equity a
could cause our common stock to be delisted from the NASDAQ Capital Market,
the
liquidity and market price of our common stock would
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.
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 June 30, 2006, our shareholders’ equity was $4.4 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. If our shareholders’ equity
decreases below $2.5 million, we will be notified by the Nasdaq Listing
Qualifications Department that we are not in compliance with the minimum
$2.5 million shareholders’ equity requirement of Nasdaq Marketplace
Rule 4320(e)(2).
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.
Concentration
of ownership of our common stock may give certain shareholders significant
influence over our business.
A small number of investors own a significant number of shares of our common
stock. As of June 30, 2006, Elan held approximately 1.2 million and Biogen
Idec
held approximately 1.2 million shares of our common stock. Together these
holdings represent approximately 23.6% of our common shares outstanding as
of
June 30, 2006. This concentration of stock ownership may allow these
shareholders to exercise significant control over our strategic decisions and
block, delay or substantially influence all matters requiring shareholder
approval, such as:
·
|
election
of directors;
|
·
|
amendment
of our charter documents; or
|
19
·
|
approval
of significant corporate transactions, such as a change of control
of
Targeted Genetics.
|
The interests of these shareholders may conflict with the interests of other
holders of our common stock with regard to such matters. Furthermore, this
concentration of ownership of our common stock could allow these shareholders
to
delay, deter or prevent a third party from acquiring control of Targeted
Genetics at a premium over the then-current market price of our common stock,
which could result in a decrease in our stock price.
Both Biogen Idec and Elan have sold shares of our common stock and may continue
to do so. Sales of significant value of stock by these investors may introduce
increased volatility to the market price of our common stock. In accordance
with
the termination agreement that we entered into with Elan with in March 2004,
Elan is only permitted to sell quantities of stock our equal to 175% of the
volume limitation set forth in Rule 144(e)(1) promulgated under the
Securities Act of 1933, as amended.
On
June
21, 2006, the Company issued 20,000 shares of common stock to Needham &
Company, LLC in lieu of cash payments for expenses and fees, and the issuance
of
warrants. The compensation due to Needham was in connection with an engagement
the Company had with Needham and the referral of one of the investors in the
Company’s registered offering in March 2006 from Needham. The Company received a
release of any claims Needham may have had against the Company as consideration
for the shares. The securities were issued under Section 4(2) of the Securities
Act of 1933, as amended, to an institutional investor.
On
July
10, 2006, the Company issued 25,000 shares of common stock to the International
AIDS Vaccine Initiative as part of the consideration for the Collaboration
and
License Agreement, dated January 1, 2005, by and among the International AIDS
Vaccine Initiative, Children’s Research Institute, The Children’s Hospital of
Philadelphia, and the Company. The securities were issued under Section 4(2)
of
the Securities Act of 1933, as amended, to an accredited investor.
Certain
of our loan agreements contain financial covenants establishing limits on our
ability to declare or pay cash dividends.
None.
We
held
an annual meeting of our shareholders on May 8, 2006. Of the 85,707,244 shares
outstanding as of the record date for the annual meeting, 79,149,470 shares,
or
92.35% of the total shares eligible to vote at the annual meeting, were
represented in person or by proxy.
1) |
At
the annual meeting, Nelson L. Levy, H. Stewart Parker and Michael
S. Perry
were each elected to serve as Class 3 members of our board of directors,
each to hold office for a three-year term or until his successor
is
elected and qualified and Roger Hawley was elected to serve as Class
2
members of our board of directors, each to hold office for a two-year
term
or until his successor is elected and qualified. The Board members
whose
terms in office continued after the annual meeting were Jeremy L.
Curnock
Cook (chairman), Jack L. Bowman, Joseph Davie, and Louis Lacasse.
Each of
the directors who stood for reelection was elected with the following
voting results:
|
Nominee
|
Votes
For
|
Votes
Withheld
|
|||||
Nelson
L. Levy
|
78,067,294
|
1,082,176
|
|||||
H.
Stewart Parker
|
77,890,292
|
1,259,178
|
|||||
Michael
S. Perry
|
78,070,935
|
1,078,535
|
|||||
Roger
L. Hawley
|
78,069,104
|
1,080,366
|
20
2)
|
A
proposal to approve an amendment and restatement of our Amended and
Restated Articles of Incorporation to (i) effect a stock combination
(reverse stock split) of the Common Stock in a ratio of either
one-for-five, one-for-seven, or one-for-ten, as may be determined
by the
Board of Directors, (ii) establish, depending on the ratio of the
reverse
stock split, the authorized shares of Common Stock at 36,000,000,
25,714,286, or 18,000,000 shares, respectively, and the authorized
shares
of our Preferred Stock to 1,200,000, 857,143, or 600,000 shares,
respectively (of which 360,000, 257,143, or 180,000 shares, respectively,
shall be designated Series A Participating Cumulative Preferred Stock),
after giving effect to the reverse stock split and (iii) make other
ministerial changes, and to authorize the Board of Directors, if
determined appropriate by the Board of Directors at any time before
the
2007 annual meeting of shareholders, to file such an amendment and
restatement of our Amended and Restated Articles of Incorporation
reflecting the ratio it has selected, passed with the following
results:
|
Votes
For
|
Votes
Against
|
Abstain
|
Broker
Non-Votes
|
|||||||
74,808,107
|
4,129,343
|
212,017
|
0
|
3)
|
A
proposal to approve the ratification of Ernst &Young LLP as the
Company’s independent registered public accounting firm passed with the
following results:
|
Votes
For
|
Votes
Against
|
Abstain
|
|||||
78,737,7555
|
317,337
|
94,375
|
None.
See
the
Index to Exhibits included in this quarterly report.
21
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: August 9, 2006 | By: | /s/ H. STEWART PARKER |
H.
Stewart Parker,
President,
Chief Executive Officer and Director
(Principal
Executive Officer)
|
|
|
|
Date: August 9, 2006 | By: | /s/ DAVID J. POSTON |
David
J. Poston,
Vice
President and Chief Financial Officer
(Principal
Financial and Accounting
Officer)
|
22
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
|
05/10/2006
|
3.1
|
|||||
3.2
|
|
Amended
and Restated Bylaws
|
|
10-K
|
12/31/1996
|
3.2
|
|||||
10.1
|
Sixth
Lease Amendment, dated April 25, 2006, between Targeted Genetics
and
Walton Corporation
|
10-Q
|
3/31/2006
|
10.4
|
|||||||
10.2
|
Seventh
Lease Amendment dated as of June 7, 2006 by and between Targeted
Genetics
Corporation and Met Park West IV, L.L.C.
|
8-K
|
6/21/2006
|
10.1
|
|||||||
10.3
|
Collaboration
and License Agreement, dated as of January 1, 2005, by and among
Targeted
Genetics, the International AIDS Vaccine Initiative, Columbus Children’s
Research Institute, and The Children’s Hospital of
Philadelphia*
|
X
|
|||||||||
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
|
||||||
* |
Portions
of these exhibits have been omitted based on a grant of or application
for
confidential treatment from the SEC. The omitted portions of
these
exhibits have been filed separately with the
SEC.
|
23