Armata Pharmaceuticals, Inc. - Quarter Report: 2007 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
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x
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QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2007
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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 o Accelerated
filer o Non-accelerated
filer x
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 October 29, 2007:
19,814,161
TARGETED
GENETICS CORPORATION
Quarterly
Report on Form 10-Q
For
the
quarter ended September 30, 2007
TABLE
OF
CONTENTS
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Page No.
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PART I
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FINANCIAL
INFORMATION
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Item 1.
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Financial
Statements
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a)
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Condensed
Consolidated Balance Sheets at September 30, 2007 and December
31, 2006
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1
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b)
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Condensed
Consolidated Statements of Operations for the three and nine months
ended
September 30, 2007 and 2006
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2
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c)
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Condensed
Consolidated Statements of Cash Flows for the nine months ended
September
30, 2007 and 2006
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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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10
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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
4T.
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Controls and
Procedures
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17
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PART
II
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OTHER
INFORMATION
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17
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Item
1.
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Legal
Proceedings
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17
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Item
1A.
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Risk
Factors
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17
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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20
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Item
3.
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Defaults
Upon Senior Securities
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20
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Item
4.
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Submission
of Matters to a Vote of Security Holders
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20
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Item
5.
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Other
Information
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20
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Item
6.
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Exhibits
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20
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SIGNATURES
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21
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INDEX
TO EXHIBITS
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22
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i
PART
I FINANCIAL INFORMATION
Item
1. Financial
Statements
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30,
|
December 31,
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||||||
2007
|
2006
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
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$
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20,531,000
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$
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6,206,000
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|||
Accounts
receivable
|
1,544,000
|
1,498,000
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|||||
Prepaid
expenses and other
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321,000
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531,000
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|||||
Total
current assets
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22,396,000
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8,235,000
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|||||
Property
and equipment, net
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986,000
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1,100,000
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|||||
Goodwill
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7,926,000
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7,926,000
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|||||
Other
assets
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200,000
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206,000
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|||||
Total
assets
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$
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31,508,000
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$
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17,467,000
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LIABILITIES
AND SHAREHOLDERS’ EQUITY
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|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
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$
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2,058,000
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$
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1,901,000
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|||
Accrued
employee expenses
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702,000
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861,000
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|||||
Accrued
restructure charges
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1,643,000
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1,046,000
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|||||
Deferred
revenue
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218,000
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251,000
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|||||
Current
portion of long-term obligations
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504,000
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1,129,000
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|||||
Total
current liabilities
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5,125,000
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5,188,000
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Accrued
restructure charges
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5,506,000
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6,331,000
|
|||||
Long-term
obligations
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—
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570,000
|
|||||
Deferred
rent
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9,000
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11,000
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|||||
Commitments
and Contingencies
|
|||||||
Shareholders’
equity:
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|||||||
Preferred
stock, $0.01 par value, 600,000 shares authorized:
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|||||||
Series
A preferred stock, 180,000 shares designated, none issued and
outstanding
|
—
|
—
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|||||
Common
stock, $0.01 par value, 30,000,000 shares authorized, 19,814,161
shares
issued and outstanding at September 30, 2007 and 10,921,736 shares
issued
and outstanding at December 31, 2006
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198,000
|
109,000
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|||||
Additional
paid-in capital
|
315,744,000
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289,324,000
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|||||
Accumulated
deficit
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(295,080,000
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)
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(284,027,000
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)
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|||
Accumulated
other comprehensive gain (loss)
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6,000
|
(39,000
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)
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||||
Total
shareholders’ equity
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20,868,000
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5,367,000
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|||||
Total
liabilities and shareholders’ equity
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$
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31,508,000
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$
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17,467,000
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See
accompanying notes to condensed consolidated financial statements
1
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended
September 30, |
Nine months ended
September 30, |
||||||||||||
2007
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2006
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2007
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2006
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||||||||||
Revenue:
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|||||||||||||
Collaborative
revenue
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$
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1,943,000
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$
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2,012,000
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$
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6,612,000
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$
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5,856,000
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|||||
Licensing
revenue
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500,000
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—
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500,000
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—
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|||||||||
Total
revenue
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2,443,000
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2,012,000
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7,112,000
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5,856,000
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|||||||||
Operating
expenses:
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|||||||||||||
Research
and development
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3,874,000
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3,123,000
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12,840,000
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10,483,000
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|||||||||
General
and administrative
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1,694,000
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1,687,000
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4,821,000
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4,736,000
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|||||||||
Restructure
charges
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183,000
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413,000
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809,000
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1,818,000
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|||||||||
Goodwill
impairment charge
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—
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—
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—
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23,723,000
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|||||||||
Total
operating expenses
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5,751,000
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5,223,000
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18,470,000
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40,760,000
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|||||||||
Loss
from operations
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(3,308,000
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)
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(3,211,000
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)
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(11,358,000
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)
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(34,904,000
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)
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|||||
Investment
income
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277,000
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147,000
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305,000
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468,000
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|||||||||
Interest
expense
|
—
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(126,000
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)
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(1,000
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)
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(362,000
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)
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||||||
Net
loss
|
$
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(3,031,000
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)
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$
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(3,190,000
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)
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$
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(11,054,000
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)
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$
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(34,798,000
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)
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Net
loss per common share (basic and diluted)
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$
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(0.15
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)
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$
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(0.32
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)
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$
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(0.72
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)
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$
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(3.64
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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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19,814,000
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9,894,000
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15,388,000
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9,548,000
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See
accompanying notes to condensed consolidated financial statements
2
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine months ended
|
|||||||
September
30,
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|||||||
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2007
|
2006
|
|||||
Operating
activities:
|
|||||||
Net
loss
|
$
|
(11,054,000
|
)
|
$
|
(34,798,000
|
)
|
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Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
|
447,000
|
537,000
|
|||||
Stock-based
compensation
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514,000
|
691,000
|
|||||
Stock
issued to outside service providers
|
—
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141,000
|
|||||
Goodwill
impairment charge
|
—
|
23,723,000
|
|||||
Gain
on the sale of property and equipment
|
(22,000
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)
|
—
|
||||
Loss
(gain) on investments
|
251,000
|
(8,000
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)
|
||||
Changes
in assets and liabilities:
|
|||||||
Increase
in accounts receivable
|
(46,000
|
)
|
(233,000
|
)
|
|||
Decrease
(increase) in prepaid expenses and other
|
(12,000
|
)
|
48,000
|
||||
Decrease
in other assets
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6,000
|
8,000
|
|||||
Increase
(decrease) in current liabilities
|
(1,000
|
)
|
38,000
|
||||
Increase
(decrease) in deferred revenue
|
(33,000
|
)
|
45,000
|
||||
Decrease
in deferred rent
|
(2,000
|
)
|
(99,000
|
)
|
|||
Increase
(decrease) in accrued restructure expenses
|
(228,000
|
)
|
385,000
|
||||
Net
cash used in operating activities
|
(10,180,000
|
)
|
(9,522,000
|
)
|
|||
Investing
activities:
|
|||||||
Purchases
of property and equipment
|
(333,000
|
)
|
(72,000
|
)
|
|||
Proceeds
from the sale of property and equipment
|
22,000
|
—
|
|||||
Proceeds
from sale of investments
|
16,000
|
49,000
|
|||||
Net
cash used in investing activities
|
(295,000
|
)
|
(23,000
|
)
|
|||
Financing
activities:
|
|||||||
Net
proceeds from sales of common stock
|
25,956,000
|
4,826,000
|
|||||
Proceeds
from the exercise of stock options
|
39,000
|
12,000
|
|||||
Payments
under debt and equipment financing arrangements
|
(1,195,000
|
)
|
(135,000
|
)
|
|||
Net
cash provided by financing activities
|
24,800,000
|
4,703,000
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
14,325,000
|
(4,842,000
|
)
|
||||
Cash
and cash equivalents, beginning of period
|
6,206,000
|
14,122,000
|
|||||
Cash
and cash equivalents, end of period
|
$
|
20,531,000
|
$
|
9,280,000
|
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, 2006 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 nine months ended
September 30, 2007 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, 2006.
Our
combined cash and cash equivalents totaled $20.5 million at September 30, 2007.
We
believe that our current resources, including the capital raised in January
and
June 2007 and the cash anticipated to be received from our collaborative
partners, are sufficient to fund our currently planned operations, including
our
clinical trials, for at least a year. This
estimate is based on our ability to perform planned research and development
activities and the receipt of planned, but not yet approved, funding from our
collaborators. Our
near-term financing strategy includes leveraging our development capabilities
and intellectual property assets into additional commercial opportunities,
advancing our clinical development programs, and accessing the public and
private capital markets at appropriate times.
Depending on our ability to successfully access additional funding, we
may
be
forced to preserve our cash position through a combination of cost reduction
measures, sales of assets likely at values significantly below their potential
worth, or the pursuit of alternative financing transactions that would likely
be
on terms disadvantageous to us and dilutive to our shareholders. We
have
prepared the accompanying financial statements on a going concern basis, which
assumes that we will realize our assets and satisfy our liabilities in the
normal course of business. The
accompanying financial statements do not include any adjustments that may impact
the amount and classifications of assets or liabilities that may result from
these liquidity uncertainties.
Accounting
for Uncertainties in Income Taxes
Recently
Issued Accounting Standards
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157, “Fair
Value Measurements,”
or SFAS
No. 157. SFAS No. 157 provides guidance for using fair value to
measure assets and liabilities and requires expanded information about the
extent to which companies measure assets and liabilities at fair value, the
information used to measure fair value, and the effect of fair value
measurements on earnings. The standard applies whenever other standards require
or permit assets or liabilities to be measured at fair value. The standard
does
not expand the use of fair value in any new circumstances. SFAS No. 157 is
effective for fiscal years beginning after November 15, 2007. We are in the
process of evaluating the adoption of SFAS No. 157 and have not yet
determined its impact, if any.
4
2. Long-Term
Obligations
Long-term
obligations consist of the following:
|
September 30,
|
December 31,
|
|||||
2007
|
2006
|
||||||
Loans
payable to Biogen Idec
|
$
|
501,000
|
$
|
1,672,000
|
|||
Equipment
financing obligations
|
3,000
|
27,000
|
|||||
Total
obligations
|
504,000
|
1,699,000
|
|||||
Less
current portion
|
(504,000
|
)
|
(1,129,000
|
)
|
|||
Total
long-term obligations
|
$
|
—
|
$
|
570,000
|
As
of
September 30, 2007, we owed $501,000 to Biogen Idec, a beneficial owner of
approximately 11% of our outstanding common shares. This
debt
is the remaining balance of a $10.0 million loan from Biogen Idec initiated
in
2001. In the fourth quarter of 2006, as
part
of a debt restructuring, we agreed to terms that resulted in a loan payable
balance of $2.2 million, which consisted of $2.0 million principal and $167,000
of estimated future interest payments to be paid to Biogen Idec in two
installments: $1.0 million plus accrued interest, which we paid on August 1,
2007, and the remaining balance which is due on August 1, 2008. We
must
apply one-third of certain up-front payments received from potential future
corporate collaborations and one-third of certain milestone payments 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. Since December 2006, as a result of the receipt of
upfront payments in the fourth quarter of 2006 and the first three quarters
of
2007, we have made principal and interest payments totaling $917,000. The note
balance of $501,000 as of September 30, 2007 includes principal of $410,000
and
interest of $91,000. As of September 30, 2007, future aggregate principal
payments related to the Biogen Idec debt are $410,000 in 2008 and zero there
after. Subsequent to quarter end, we made a $161,000 principal payment in
October 2007.
3. Accrued
Restructure Charges
We
apply
the provisions of SFAS No. 146, “Accounting
for Costs Associated with Exit or Disposal Activities,” as
it
relates to our facility in Bothell, Washington and record restructure charges
on
the operating lease for the facility as a result of our 2003 decision to
discontinue use of the facility. Accrued restructure charges represent our
best
estimate of the fair value of the liability as determined under SFAS No. 146
and
are computed as the fair value of the difference between the remaining lease
payments, net of assumed sublease income and expense. We also record accretion
expense based upon changes in the accrued liability that results from the
passage of time at an assumed discount rate of 10%. Accretion expense is
recorded on an ongoing basis through the end of the lease term in September
2015
and is reflected as a restructuring charge in the accompanying condensed
consolidated statements of operations.
The
table
below presents a reconciliation of the accrued restructure liability for the
nine month period ended September 30, 2007:
Contract
Termination Costs
|
||||
December
31, 2006 accrued liability
|
$
|
7,377,000
|
||
Charges
related to changes in lease assumptions
|
260,000
|
|||
Accretion
expense
|
549,000
|
|||
Amount
paid
|
(1,037,000
|
)
|
||
September
30, 2007 accrued liability
|
$
|
7,149,000
|
During
the second quarter of 2007, we recorded additional restructure charges of
$260,000 as a result of updating our estimates of costs and sublease income
associated with exiting the Bothell facility. As part of this assessment we
extended the anticipated lead time for subleasing the facility. In addition
to
this adjustment to the accrued restructure liability, we incurred $183,000
of
accretion expense for the three months ended September 30, 2007 and $549,000
of
accretion expense for the nine months ended September 30, 2007. The total of
these charges and adjustments to the liability are reflected as restructure
charges in the accompanying consolidated statements of operations.
Through
September 30, 2007, we have recorded contract termination costs totaling $10.8
million for our Bothell facility. As of September 30, 2007, we expect to incur
an additional $2.6 million in accretion expense through the expiration of the
Bothell lease in September 2015. If we were to determine that we were unable
to
sublease the facility, we would record additional restructure charges of $1.2
million.
5
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
June
27, 2007, we sold 6.7 million shares of our common stock in a private placement
at a price of $2.905 per share and received net proceeds of approximately $17.8
million. In addition, in connection with the financing, we issued warrants
to
purchase up to 6.7 million shares of our common stock. These warrants expire
in
June 2012 and are exercisable at a price of $3.25 per share. We also issued
a
warrant with the same terms as those issued pursuant to our private placement
to
purchase 334,989 shares of our common stock as compensation to the placement
agent in this transaction.
On
January 11, 2007, we sold 2.2 million shares of our common stock in a private
placement at a price of $4.00 per share and received net proceeds of
approximately $8.1 million. In addition, in connection with the financing,
we
issued warrants to purchase up to 763,000 shares of ou r common stock. These
warrants expire in January 2012 and are exercisable at $5.41 per share. We
also
issued a warrant with the same terms as those issued pursuant to the private
placement to purchase 16,119 shares of our common stock as compensation to
the
placement agent in this transaction.
Stock
Based Compensation
In
May
2007, our shareholders approved our proposal to amend, restate and rename the
Targeted Genetics Corporation 1999 Stock Option Plan into the Targeted Genetics
Corporation Stock Incentive Plan (Stock Incentive Plan). The Stock Incentive
Plan provides for the issuance of long-term incentive awards (Awards) in the
form of nonqualified and incentive stock options (Options), stock appreciation
rights, stock grants and restricted stock units. The Awards 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 Options must not be less than the fair market
value of the shares on the date of grant. Options 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 2006, as part of an employee
retention plan, we granted options to purchase an aggregate of 306,500 shares
of
our common stock with a twelve-month vesting period. Restricted stock units
expire no later than 10 years from the date of grant and generally vest over
a
three-year period following the date of grant. Every non-employee member of
our
Board of Directors receives an annual nonqualified stock option or restricted
stock unit grant and these awards vest over a twelve-month period provided
the
grantee continues service to us. Upon the exercise of stock options and the
vesting of restricted stock units, we issue new shares from shares reserved
for
issuance under our Stock Incentive Plan.
Effective
January 2006, we adopted SFAS No. 123R, “Share-Based
Payment”
which
requires us to expense the fair value of share-based payments granted over
the
vesting period. 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
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. We value awards granted subsequent to January
1, 2006 at fair value in accordance with provisions of SFAS No. 123R and
recognize stock-based compensation expense on a straight line basis over the
service period of each award. Stock-based
compensation expense is reduced by an estimated forfeiture rate that we derived
from historical employee termination behavior. If the actual number of
forfeitures differs from our estimates, we may record adjustments to increase
or
decrease compensation expense in future periods.
6
Following
is a summary of our compensation expense for the three and nine months ended
September 30, 2007:
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
||||||||||||
|
|
2007
|
2006
|
2007
|
2006
|
||||||||
Stock
options:
|
|||||||||||||
Research
and development expense
|
$
|
1,000
|
$
|
117,000
|
$
|
195,000
|
$
|
379,000
|
|||||
General
and administrative expense
|
7,000
|
110,000
|
157,000
|
312,000
|
|||||||||
Restricted
stock units:
|
|||||||||||||
Research
and development expense
|
38,000
|
—
|
55,000
|
—
|
|||||||||
General
and administrative expense
|
73,000
|
—
|
107,000
|
—
|
|||||||||
Total
compensation expense
|
$
|
119,000
|
$
|
227,000
|
$
|
514,000
|
$
|
691,000
|
Stock
Options
Following
is a summary of stock option activity and related prices for the first nine
months of 2007:
|
Shares
|
Weighted
Average
Exercise
Price
|
Remaining
Average
Contractual
Term(Years)
|
Intrinsic
Value
|
|||||||||
Outstanding,
December 31, 2006
|
835,085
|
$
|
15.39
|
||||||||||
Granted
|
15,800
|
3.88
|
|||||||||||
Exercised
|
(12,632
|
)
|
3.10
|
||||||||||
Expired
|
(13,892
|
)
|
40.66
|
||||||||||
Forfeited
|
(43,353
|
)
|
8.95
|
||||||||||
Outstanding,
September 30, 2007
|
781,008
|
$
|
15.26
|
6.51
|
$
|
3,000
|
|||||||
Exercisable
at September 30, 2007
|
688,694
|
$
|
16.17
|
6.34
|
$
|
1,000
|
The
aggregate intrinsic value is determined using the closing price of our common
stock of $1.87 on September 28, 2007. The intrinsic value of stock options
exercised was $22,000 during the nine months ended September 30, 2007 and $3,000
during the nine months ended September 30, 2006. We received $39,000 from the
exercise of stock options for the nine months ended September 30, 2007 and
$2,000 for the nine months ended September 30, 2006.
As
of
September 30, 2007, total unrecognized compensation cost related to unvested
options was approximately $171,000, net of estimated forfeitures, which we
expect to recognize over a weighted average period of approximately one year.
Stock
options outstanding and exercisable as of September 30, 2007 are summarized
below:
Outstanding
|
Exercisable
|
|||||||||||||||
Range
of Exercise Prices
|
Number of
Option
Shares
|
Weighted
Average
Exercise
Price
|
Weighted Average
Remaining
Contractual
Life
(Years)
|
Number
of
Option
Shares
|
Weighted
Average
Exercise
Price
|
|||||||||||
$1.80
- $3.24
|
94,233
|
$
|
2.50
|
8.31
|
82,725
|
$
|
2.54
|
|||||||||
3.80 - 3.80
|
187,000
|
3.80
|
8.69
|
187,000
|
3.80
|
|||||||||||
3.87 - 9.10
|
167,245
|
7.28
|
7.11
|
113,561
|
7.27
|
|||||||||||
10.80 - 14.90
|
157,370
|
13.10
|
6.28
|
131,435
|
13.10
|
|||||||||||
15.30 - 148.80
|
175,160
|
43.92
|
2.85
|
173,973
|
44.07
|
|||||||||||
Balance,
September 30, 2007
|
781,008
|
$
|
15.26
|
6.51
|
688,694
|
$
|
16.17
|
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
weighted average fair value of options granted during the nine months ended
September 30, 2007 was $3.88 and was $1.84 for the nine months ended September
30, 2006.
7
The
following are the weighted average assumptions for the periods
noted:
Nine Months ended September 30,
|
|||||||
2007
|
2006
|
||||||
Expected
dividend rate
|
Nil
|
Nil
|
|||||
Expected
stock price volatility
|
1.047
- 1.114
|
1.067-1.107
|
|||||
Risk-free
interest rate range
|
4.54
- 4.58%
|
|
4.25-4.85%
|
|
|||
Expected
life of options
|
4
- 5 years
|
4-5
years
|
Expected
Dividend: We
do not
anticipate any dividends. The terms of our Biogen Idec loan restricts our
ability to declare or pay dividends.
Expected
Life: Our
expected life represents the period that our stock-based awards are expected
to
be outstanding. We determine expected life based on historical experience and
vesting schedules of similar awards.
Expected
Volatility: Our
expected volatility represents the weighted average historical volatility of
the
shares of our common stock for the most recent four-year and five-year periods.
Risk-Free
Interest Rate: We
base the risk-free interest rate used on the implied yield currently available
on U.S. Treasury zero-coupon issues with an equivalent remaining term.
Where the expected term of our stock-based awards do not correspond with the
terms for which interest rates are quoted, we perform a straight-line
interpolation to determine the rate from the available term
maturities.
Restricted
Stock Units
|
Shares
|
Weighted
Average
Grant
Date Fair
Value
|
|||||
Nonvested,
December 31, 2006
|
—
|
$
|
—
|
||||
Granted
|
528,000
|
3.10
|
|||||
Vested
|
—
|
—
|
|||||
Forfeited
|
(2,500
|
)
|
3.14
|
||||
Nonvested,
September 30, 2007
|
525,500
|
$
|
3.10
|
As
of
September 30, 2007, total unrecognized compensation cost related to unvested
restricted stock units was approximately $802,000, net of estimated forfeitures,
which we expect to recognize over a weighted average period of approximately
2.4
years.
Comprehensive
loss is the total of net loss and all other non-owner changes in equity.
Comprehensive loss includes net unrealized gains from investments and foreign
currency translations on our common stock investment in Chromos Molecular
Systems Inc., or Chromos, as presented in the following table:
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
||||||||||||
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
|||||
Net
loss as reported
|
$
|
(3,031,000
|
)
|
$
|
(3,190,000
|
)
|
$
|
(11,054,000
|
)
|
$
|
(34,798,000
|
)
|
|
Other
comprehensive income or loss:
|
|||||||||||||
Unrealized
gain (loss) on available-for-sale securities
|
—
|
(22,000
|
)
|
—
|
26,000
|
||||||||
Foreign
currency translation adjustment
|
6,000
|
2,000
|
6,000
|
15,000
|
|||||||||
Comprehensive
loss
|
$
|
(3,025,000
|
)
|
$
|
(3,210,000
|
)
|
$
|
(11,048,000
|
)
|
$
|
(34,757,000
|
)
|
6.
Investments
As
of
September 30, 2007, we
held
approximately 2.4 million shares of
Chromos,
a
publicly traded company whose common stock is listed on the Toronto Stock
Exchange. Periodically, we sell these shares on a specific identification method
based on when we received the shares. During the nine months ended September
30,
2007, we sold 100,000 shares resulting in a realized gain of
$1,000.
8
We
record
our common stock investment in Chromos at fair market value and record changes
in the fair market value of this stock in accumulated other comprehensive loss
in the accompanying condensed
consolidated balance sheets.
We
periodically evaluate our Chromos stock for signs of impairment that may be
other-than-temporary, which would necessitate a reduction in the carrying value
of the investment and charge to expense. During the first and second quarters
of
2007, due to the
declining market value of the Chromos securities and a decline in Chromos’
current financial position, we determined that our investment is
other-than-temporarily impaired. Accordingly, we wrote the asset down to the
fair market value of the Chromos stock on both March 31, 2007 and June 30,
2007
and recognized a realized loss of $208,000 in the first quarter and an
additional realized loss of $44,000 in the second quarter. We evaluated the
investment again on September 30, 2007 and based on additional facts about
Chromos, we determined that our investment was not further impaired at that
date. We recognized an unrealized gain due to a change in the exchange rate
for
the Canadian dollar during the third quarter of 2007. We continue to monitor
the
status of Chromos.
Following
is a summary of our Investment activity for the nine months ended September
30,
2007:
Fair
Value
|
Unrealized
Gain
|
Proceeds
from
the
sale
of
securities
|
Net
Realized
Loss
|
||||||||||
Marketable
equity securities
|
$
|
95,000
|
$
|
6,000
|
$
|
16,000
|
$
|
(251,000
|
)
|
7.
Goodwill
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, in
the
second quarter of 2006, as a result of a decline in market price of our common
stock in June 2006, to a level that reduced our market capitalization to an
amount less than the fair value of our 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 we are comprised of only one reporting unit, we compared our fair value,
as measured by market capitalization and discounted cash flow analysis, to
the
net carrying value of our assets. Since our indicated fair value in this June
2006 test 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 required us to determine the implied value
of
goodwill by allocating our estimated fair value 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 we 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. Since the second quarter of 2006, we have
had no further indications of impairment on our goodwill balance.
8.
Income Taxes
We
adopted the provisions of FASB Interpretation No. 48, “Accounting
for Uncertainty in Income Taxes”,
or FIN
48, on January 1, 2007. We have been in a net operating loss position since
inception and have not recognized any tax benefits for any of our income tax
positions as a result of a full valuation allowance. There were no changes
to
the amount of recognized tax benefits as a result of adopting FIN 48, and there
were no changes to the recognized tax benefits during the three and nine months
ended September 30, 2007.
Historically,
we have not incurred any interest or penalties associated with tax matters
and
no interest or penalties were recognized during the three and nine months ended
September 30, 2007. We have adopted a policy whereby amounts related to interest
and penalties associated with tax matters are classified as additional income
tax expense when incurred.
Tax
years
that remain open for examination include 2003, 2004, 2005, and 2006. In
addition, tax years from our inception in 1992 to 2002 may be subject to
examination in the event we utilize the net operating losses from those years
in
our current or future year tax returns.
9
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 within the
meaning of the private Securities Litigation Reform Act of 1995. All statements
other than statements of historical fact are forward-looking and 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 a 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 greater detail in the
section entitled “Risk Factors” in Part I, Item IA of our annual report on Form
10-K for the year ended December 31, 2006, as supplemented by 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 risk factors and other information
we provide in the reports we file from time to time with the SEC.
BUSINESS
OVERVIEW
We
are a
clinical-stage therapeutic biotechnology company. We are at the forefront of
developing, with the goal of commercializing, a new class of therapeutic
products called gene therapeutics. We believe that a wide range of diseases
may
potentially be treated or prevented with gene therapeutics. In addition to
treating diseases that have not had treatments in the past, we believe that
there is also a significant opportunity to use gene therapeutics to more
effectively treat diseases that are currently treated using other therapeutic
classes of drugs such as protein-based drugs, monoclonal antibodies or small
molecule drugs.
Gene
therapeutics 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 therapeutics may be used to
treat disease facilitating the normal protein production or gene regulation
capabilities of cells. Gene therapeutics may be used to enable cells to produce
more of a certain protein or different proteins than they normally produce
thereby treating a disease state. Gene therapeutics may also be used for RNAi
interference, or RNAi, to deliver small RNA molecules that once delivered into
the cell may shut down or interfere with cellular functions.
We
and
our partners, Celladon Corporation, or Celladon, the National Institute of
Allergy and Infectious Diseases, or NIAID, the International
AIDS Vaccine Initiative, or IAVI,
the
Children’s Hospital of Philadelphia, or CHOP, and The Research Institute at
Nationwide Children’s Hospital (formerly known as the Columbus Children’s
Research Institute), or NCH, are primarily focused on the following adeno-associated
viral vectors, or AAV, based product
development programs:
Description
|
Indication
|
Partners
|
Development
Status
|
|||
AAV
delivery of TNF-alpha antagonist
|
Inflammatory
Arthritis
|
None
|
Phase
I/II
|
|||
AAV
delivery of HIV antigens
|
HIV/AIDS
|
IAVI,
CHOP and NCH
|
Phase
II
|
|||
AAV
delivery of SERCA2a
|
Congestive
Heart Failure
|
Celladon
|
Phase
I
|
|||
AAV
delivery of HIV antigens
|
HIV/AIDS
|
CHOP,
NCH and NIAID
|
Preclinical
|
|||
AAV
expression of htt shRNA (RNAi)
|
Huntington’s
disease
|
Sirna
Therapeutics as a subsidiary of Merck
|
Preclinical
|
10
In
the
first nine months of 2007, we made progress in our development collaborations
and our product development programs and expanded and leveraged our patent
portfolio. More specifically:
·
|
In
June 2007, we reported additional data from our ongoing Phase I/II
clinical trial of our inflammatory arthritis candidate that demonstrated
safety and a trend in two-point reduction in swelling in treated
joints
compared to placebo. We completed enrollment and initial dosing in
this
trial in May 2007. However, the trial was placed on clinical hold
in July
2007
after a patient participating in the clinical trial experienced a
serious
adverse event, or SAE, and subsequently died. In September 2007,
the
National Institutes of Health Recombinant DNA Advisory Committee
held a
public hearing which reviewed the SAE. Evidence presented at the
hearing
suggested that the subject died of an invasive fungal infection.
The
medications the subject was on are known to be a risk factor for
histoplasma infection, which is a fungal infection. Biochemical evidence
that the subject already had fungal infection prior to the second
dose was
also reported at the meeting. Additionally, initial molecular tests
showed
there was no amplification of vector and only trace amounts of vector
DNA
in tissues outside the joint. Consequently, we believe these data
suggest
it is unlikely that our experimental inflammatory arthritis candidate
contributed to the conditions that caused the death.
|
·
|
In
February 2007, we reported results from a Phase I clinical trial
of our
investigational HIV/AIDS vaccine candidate which we have partnered
with
IAVI. The results of this study, which was funded and run by
IAVI,
indicated favorable safety and tolerability profiles consistent with
the
results observed in clinical trials to date, and provided the rationale
for evaluating the vaccine at higher doses and at different dosing
intervals. The
Phase I clinical trial was a dose escalation safety trial and was
conducted in Germany, Belgium and India.
In addition, in August 2007, we presented interim results from a
separate
Phase II clinical trial of our partnered investigational HIV/AIDS
vaccine
candidate that demonstrated that the vaccine was safe and well tolerated
and that modest immune responses were shown in some recipients who
received higher doses. The Phase II clinical trial is also being
funded
and run by IAVI and is being conducted in South Africa, Uganda and
Zambia
to evaluate a higher dose and to systematically evaluate the utility
and
optimal timing of boost vaccination.
|
·
|
In
May 2007, the first patient was dosed in the Phase I clinical trial
of
MYDICAR, which is our partnered congestive heart failure product
candidate
under development through our collaboration with Celladon.
|
·
|
In
May 2007, in collaboration with the University
College London's Institute of Ophthalmology and Moorfields Eye Hospital,
a
Phase I/II clinical trial was initiated to test the use of an
AAV
vector to deliver RPE65 to treat
a
form of childhood blindness. We produced
the vector used in this trial. The trial is funded by the UK Department
of
Health.
|
·
|
In
September 2007, we received a milestone payment from Amsterdam Molecular
Therapeutics upon initiation of a clinical trial for AMT-011, an
AAV1-based therapy for LPL
deficiency.
|
·
|
We
have received issuances of additional patents, strengthening our
AAV
vector patent portfolio and expanding the potential applications
of
AAV-based gene delivery.
|
Most
of
our expenses are related to advancing our research and development programs,
conducting preclinical studies and clinical trials and for general and
administrative support of these activities. We have financed the company
primarily through proceeds from public and private sales of our equity
securities, cash payments received from our collaborative partners for product
development and manufacturing activities, proceeds from the issuance of debt
and, to a lesser extent, through loan funding under equipment financing
arrangements. During 2007, we completed two private placements of our common
stock generating approximately $26.0 million to fund our programs and
operations. On June 27, 2007, we sold 6.7 million shares of our common stock
in
a private placement at a price of $2.905 per share and received net proceeds
of
approximately $17.8 million. In connection with the financing we issued
five-year warrants to purchase up to 6.7 million shares of our common stock.
We
also issued a warrant to purchase 334,989 shares of our common stock as
compensation to the placement agent in this transaction. On January 11, 2007,
we
sold 2.2 million shares of our common stock in a private placement at a price
of
$4.00 per share and received net proceeds of approximately $8.1 million. In
connection with this financing we issued warrants to purchase up to 763,000
shares of our common stock. We also issued a warrant to purchase 16,119 shares
of our common stock as compensation to the placement agent in this
transaction.
As
of
September 30, 2007, our accumulated deficit totaled $295.1 million. We expect
to
generate substantial additional losses for the foreseeable future, primarily
due
to the costs associated with funding our inflammatory arthritis clinical
development program, developing and maintaining our manufacturing capabilities
and developing our intellectual property assets.
To
enable
us to successfully develop our lead inflammatory arthritis product candidate
and
other product candidates we will require access to significantly higher amounts
of capital than we currently have. 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.
11
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, 2006. The critical accounting policies, estimates and
assumptions described below have been updated to provide more recent financial
and factual information as of September 30, 2007.
Accounting
for Uncertainties in Income Taxes
Effective
the beginning of 2007, we adopted FASB Interpretation No. 48, “Accounting
for Uncertainty in Income Taxes,” or
FIN
48. FIN 48 provides guidance to address uncertainty in tax positions and
clarifies the accounting for income taxes by specifying a minimum recognition
threshold which income tax positions must achieve before being recognized in
the
financial statements. The adoption of FIN 48 had no impact on our net loss,
earnings per share or financial position for the three and nine months ended
September 30, 2007.
The
application of income tax law is inherently complex. Laws and regulations in
this area are voluminous and are often ambiguous. As such, we are required
to
make many subjective assumptions and judgments regarding our income tax
exposures. Interpretations of and guidance surrounding income tax laws and
regulations change over time. Changes in our subjective assumptions and
judgments can materially affect amounts recognized in the consolidated balance
sheets and statements of income.
RESULTS
OF OPERATIONS
Revenue
Revenue
increased to $2.4 million for the three months ended September 30, 2007 as
compared to $2.0 million for the same period in 2006. Revenue increased to
$7.1
million for the nine months ended September 30, 2007 compared to $5.9 million
for the same period in 2006. The increase in revenue for both the three and
nine
month periods primarily reflects an increase in research and development
activities under the NIAID-funded HIV/AIDS vaccine project in collaboration
with
CHOP and NCH and licensing revenue from a milestone payment received in the
third quarter. These increases were partially offset by lower research and
development activities under our collaboration with IAVI
as a
result of less development activity as the project is largely focused on
clinical testing. We
expect
that our revenue for the remainder of 2007 will continue to consist primarily
of
research and development revenue earned from the NIAID-funded HIV/AIDS vaccine
project in collaboration with CHOP and NCH and to a lesser extent, work under
our collaboration with Celladon. For the next several years, our revenue will
depend on the continuation of the current collaborations and our success in
entering into and performing under new collaborations.
Operating
Expenses
Research
and Development Expenses. Research
and development expenses increased to $3.9 million for the three months ended
September 30, 2007 compared to $3.1 million for the same period in 2006 and
increased to $12.8 million for the nine months ended September 30, 2007 compared
to $10.5 million for the same period in 2006. Costs for both the three and
nine
month periods are higher due to increased research and development costs for
our
preclinical programs, specifically the NIAID-funded HIV/AIDS vaccine program
in
collaboration with CHOP and NCH and costs incurred to support the initiation
of
clinical trials for the congestive heart failure product, which began in May
2007. Costs related to our inflammatory arthritis program increased due to
a
higher number of enrolled subjects in our Phase I/II clinical trial. This cost
increase was partially offset by lower costs related to our HIV/AIDS vaccine
collaboration with IAVI as a result of less development activity. We expect
that
our research and development expenses for the remainder of 2007 will vary
depending on the amount and timing of development efforts and outside services
necessary to advance both our self-funded and partnered clinical programs,
the
NIAID-funded HIV/AIDS vaccine project in collaboration with CHOP and NCH and
other programs in preclinical development.
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
September 30,
|
Nine months ended
September 30,
|
||||||||||||
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Programs
in clinical development:
|
|||||||||||||
Inflammatory
arthritis
|
$
|
1,091,000
|
$
|
771,000
|
$
|
2,948,000
|
$
|
2,204,000
|
|||||
Congestive
heart failure (1)
|
170,000
|
—
|
373,000
|
—
|
|||||||||
IAVI
HIV/AIDS vaccine
|
33,000
|
383,000
|
202,000
|
1,494,000
|
|||||||||
Indirect
costs and other
|
631,000
|
556,000
|
2,161,000
|
2,187,000
|
|||||||||
Total
clinical development program expense
|
1,925,000
|
1,710,000
|
5,684,000
|
5,885,000
|
|||||||||
Research
and preclinical development program expense
|
1,949,000
|
1,413,000
|
7,156,000
|
4,598,000
|
|||||||||
Total
research and development expense
|
$
|
3,874,000
|
$
|
3,123,000
|
$
|
12,840,000
|
$
|
10,483,000
|
(1)
Includes costs incurred after the clinical trial was initiated in May 2007.
Costs incurred prior to that are included as research and preclinical
development program expense.
Research
and development costs attributable to programs in clinical development include
salaries and benefits, clinical trial costs, outside services, and 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. Celladon separately manages and funds the clinical trial
costs
of our congestive heart failure program and IAVI separately manages and funds
the clinical trial costs of our HIV/AIDS vaccine program for the developing
world. 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 development activities
for
the NIAID-funded HIV/AIDS vaccine project in collaboration with CHOP and NCH
as
well as other programs prior to their transition into clinical trials. Research
and preclinical development 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 remained consistent at $1.7 million for the three
months ended September 30, 2007 and September 30, 2006. General and
administrative expense increased to $4.8 million for the nine months ended
September 30, 2007 from $4.7 million for the nine months ended September 30,
2006. General
and administrative expenses consist primarily of salaries, patent costs, legal
and audit fees and shareholder costs.
Restructure
Charges. Restructure
charges decreased to $183,000 for the three months ended September 30, 2007
compared to $413,000 for the same period in 2006. Restructure charges decreased
to $809,000 for the nine months ended September 30, 2007 compared to $1.8
million for the same period in the prior year. Restructuring charges for the
nine months ended September 30, 2007 include $260,000 related to changes in
our
estimates of the anticipated lead time to sublease the Bothell facility.
Restructuring charges for the first nine months of 2006 include charges of
$860,000 related to changes in our expectations regarding market conditions
for
the Bothell facility subleasing market, charges of $219,000 related to employee
termination benefits of our restructuring efforts to realign our cost structure
and charges of $174,000 in relation to the early termination of a portion of
our
Seattle facility lease resulting from the head count reductions. Restructuring
charges also include accretion expense of $549,000 for the nine months ended
September 30, 2007 and $564,000 for the nine months ended September 30, 2006.
Goodwill
Impairment Charge. We
periodically and annually on October 1st
evaluate
the carrying value of our goodwill in accordance with SFAS No. 142, “Goodwill
and Other Intangible Assets”
and if
there
is evidence of an impairment in value, we reduce the carrying value of the
asset. As discussed in Note 7 of the notes to our condensed consolidated
financial statements, we recognized a non-cash loss on impairment of goodwill
during second quarter of 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 our net assets, we were required to perform an
interim goodwill impairment test. As a result of this evaluation, during the
second quarter of 2006, we recognized a non-cash impairment charge of $23.7
million, which was equal to the recorded value of goodwill in excess of its
implied value.
13
Other
Income and Expense
Investment
Income.
Investment income reflects interest income earned on our short term investments
and realized gains or losses on our investment in Chromos Molecular Systems
Inc,
or Chromos. Investment income increased to $277,000 for the three months ended
September 30, 2007 compared to income of $147,000 for the same period in 2006.
The increase is due to income earned on higher average cash balances during
the
third quarter of 2007. Investment income decreased to $305,000 for the nine
months ended September 30, 2007 compared to $468,000 for the same period in
2006. Investment income for the nine month period reflects a net realized loss
of $251,000 recognized in the first and second quarters of 2007 related to
an
other-than-temporary impairment loss on our investment in Chromos due to the
declining market value of Chromos’ securities combined with a decline in
Chromos’ current financial position.
Interest
Expense.
Interest expense decreased to zero for the three months ended September 30,
2007, compared to $126,000 for the same period in 2006. Interest expense
decreased to $1,000 for the nine months ended September 30, 2007, compared
to
$362,000 for the same period in the prior year. In November 2006, we
restructured a $8.15 million outstanding loan from Biogen Idec by exchanging
$5.65 million of the balance for common shares of our stock, making a $500,000
payment and establishing a new repayment schedule for the remaining balance.
As
a result of restructuring the Biogen Idec debt, the $501,000 carrying value
of
the remaining debt as of September 30, 2007 includes the related estimated
future interest payments and accordingly, we did not record interest expense
on
the Biogen Idec debt in the three month and nine month periods ended September
30, 2007. We do not expect to record future interest expense on this
restructured debt.
LIQUIDITY
AND CAPITAL RESOURCES
We
had
cash and cash equivalents of $20.5 million at September 30, 2007 compared to
$6.2 million at December 31, 2006. Our cash and cash equivalents increased
in the nine months ended September 30, 2007 primarily reflecting the net
proceeds of $25.9 million from our January and June 2007 sales of our common
stock, partially offset by our net loss and the resulting cash used in
operations of $10.2 million and debt payments of $1.2 million made to Biogen
related to our outstanding loan.
On
June
27, 2007, we sold 6.7 million shares of our common stock in a private placement
at a price of $2.905 per share and received net proceeds of approximately $17.8
million. In addition, in connection with the financing, we issued warrants
to
purchase up to 6.7 million shares of our common stock. We also issued a warrant
to purchase 334,989 shares of our common stock as compensation to the placement
agent in this transaction. On January 11, 2007, we sold 2.2 million shares
of
our common stock in a private placement at a price of $4.00 per share and
received net proceeds of approximately $8.1 million. In addition, in connection
with the financing we issued warrants to purchase up to 763,000 shares of our
common stock. We
also
issued a warrant to purchase 16,119 shares of our common stock as compensation
to the placement agent in this transaction. 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.
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 partnered HIV/AIDS vaccine
candidate for the developing world, our inflammatory arthritis product candidate
and our partnered congestive heart failure product candidate are all in the
clinical phase of development. We expect to continue incurring significant
expense in developing and advancing our technology and product candidates 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
currently have 84,453 of unreserved authorized shares at September 30, 2007
and
will require substantial additional financial resources to fund the development
and commercialization of our lead product candidate in inflammatory
arthritis.
We
are
currently focusing our development funding on our inflammatory arthritis product
candidate, which is in Phase I/II clinical trials. 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 candidates
and fund our ongoing operations, we also have significant long-term lease
commitments that draw on our cash resources. Our most significant obligation
is
approximately $12.3 million of lease payments remaining on our Bothell facility,
which we are obligated to pay at $1.4 million to $1.6 million per year until
the
year 2015.
14
We
expect
the level of our future operating expenses to be driven by the needs of our
product development programs, our debt obligations and our lease obligations,
offset by the availability of funds through equity offerings, partner-funded
collaborations or other financing or business development activities. The size,
scope and pace of our product development activities depend on the availability
of these resources. Our future cash requirements will depend on many factors,
including:
• |
the
rate and extent of scientific progress in our research and development
programs;
|
• |
the
timing, costs and scope of, and our success in, conducting clinical
trials, obtaining regulatory approvals and pursuing patent
prosecutions;
|
• |
competing
technological and market developments;
|
• |
the
timing and costs of, and our success in, any product commercialization
activities and facility expansions, if and as required;
and
|
• |
the
existence and outcome of any litigation or administrative proceedings
involving intellectual property.
|
We
have
financed our product development activities and general corporate functions
primarily through proceeds from public and private sales of our equity
securities, through cash payments received from our collaborative partners
and
proceeds from the issuance of debt. To a lesser degree, we have also financed
our operations through interest earned on cash and cash equivalents and loan
funding under equipment financing agreements. 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 generally extends for multiple one-year
terms and is subject to termination or extension. For example, when the IAVI
collaboration was initiated in 2000, it originally had a three-year term yet
the
work plan was established and funded on an annual basis. In 2004, we and IAVI
agreed to extend the underlying program through the end of 2006 and in 2006
we
agreed to further extend the program until the expiration of the term of the
last patent within the patent rights controlled by us and utilized in the IAVI
vaccine. In 2005, we extended the scope of our HIV/AIDS vaccine program
activities to the developed world, via a NIAID-funded HIV/AIDS vaccine project
in collaboration with CHOP and NCH. To date we have received $4.2 million under
this subcontract and our portion of the remaining project funding could be
up to
an additional $14.0 million over the remaining three years of the contract.
Funding for this subcontract is awarded to us in annual installments based
on an
approved work plan and achievement of milestones.
The
funding we receive from each of our collaborative partners fully offsets our
incremental program costs related to each collaboration and our overhead and
fixed costs. Our revenue from collaborative agreements and licenses totaled
$9.9
million in 2006 and, assuming that we complete all of the planned development
activities for each of these funded projects, we expect collaborative agreement
and license revenue of up to $10 million in 2007.
Each
of
our collaborations has provisions that allow our partners the right to terminate
both the underlying collaboration and the obligation to provide research funding
at any time with as little as 90 days notice. If we were to lose the expected
funding from any of our collaborators and were unable to obtain alternative
sources of funding, we would be unable to continue our research and development
program for that product candidate and our cash horizon would be
shortened.
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. Our financing strategy is focused
around the advancement of our two programs in clinical development, advancement
of our newer development collaborations and generating value from our
intellectual assets and capabilities. There is a low level of success in
clinical trials and our ability to raise capital depends in part on clinical
trial success.
Additional
sources of financing could involve one or more of the following:
·
|
entering
into additional product development
collaborations;
|
·
|
mergers
and acquisitions;
|
15
· |
issuing
equity in the public or private markets;
|
·
|
extending
or expanding our current
collaborations;
|
·
|
selling
or licensing our technology or product candidates;
|
·
|
borrowing
under loan or equipment financing arrangements;
and/or
|
·
|
issuing
debt.
|
Additional
funding may not be available to us on reasonable terms, if at all.
We
expect
that our total cash requirements for 2007 will range from $14
million to $16 million and that our cash and cash equivalents at September
30,
2007, plus the anticipated funding from our product development collaborations
and contracts, will be sufficient to fund our currently forecast operations
for
at least a year. This estimate is based on our ability to perform planned
research and development activities and the receipt of planned funding from
our
collaborators.
Depending
on our ability to successfully access additional funding, we may be forced
to
implement additional cost reduction measures. Further adjustments may include
scaling back or delaying our inflammatory arthritis development program, staff
reductions, scaling back our intellectual property prosecution, subleasing
portions of our lab facilities, 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
We
are
exposed to market risk for the effect of interest rate changes, foreign currency
fluctuations and changes in the market values of our investments.
Items
with interest rate risk:
· Short
term investments:
Because
of the short-term nature of our investments, we believe that our exposure to
market rate fluctuations on our investments is minimal. Currently, we do not
use
any derivative or other financial instruments or derivative commodity
instruments to hedge any market risks and do not plan to employ these
instruments in the future. At September 30, 2007, we held $20.5 million in
cash,
which is primarily invested in money market funds and denominated in U.S.
dollars. An analysis of the impact on these securities of a hypothetical 10.0%
change in short-term interest rates from those in effect at September 30, 2007,
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
2007.
· Notes
payable: Our
results of operations are affected by changes in short-term interest rates
as a
result of a loan from Biogen Idec that contains a variable interest rate.
Interest payments on this loan are established quarterly based upon LIBOR plus
1%. Changes in market interest rates and the timing of these remaining interest
payments may ultimately result in adjustments to the gain on debt restructuring
we recognized in 2006. 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
September 30, 2007, about our obligations that are sensitive to changes in
interest rate fluctuations:
Expected
Maturity Date
|
|||||||||||||||||||
|
2007
|
2008
|
2009
|
2010
|
2011
|
Total
|
|||||||||||||
Variable
rate note
|
$
|
—
|
$
|
410,000
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
410,000
|
Items
with market and foreign currency exchange risk:
· Investment
in Chromos Molecular Systems, Inc.:
At
September 30, 2007, we held 2.4 million shares of Chromos common shares with
a
market value of $0.04 per common share as quoted by the Toronto Stock Exchange
and denominated in Canadian dollars. As of September 30, 2007 the Canadian
dollar to US dollar exchange rate was US $1.00712 per CA $1.00. As of September
30, 2007, this investment is recorded at $95,000 and is classified within
prepaid expenses and other in
the
accompanying condensed
consolidated balance sheet.
We
recorded a net realized loss of $251,000 in the nine months ended September
30,
2007 due to an other-than-temporary impairment resulting from a decline in
market value of the Chromos securities combined with decline in Chromos’ current
financial position. 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 100,000 shares of Chromos stock in the nine months ended
September 30, 2007, we recorded $1,000 of realized gains and received $16,000
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 in the open market.
16
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 SEC rules
and
forms.
Changes
in internal control over financial reporting. There
was
no change in our internal control over financial reporting, that occurred during
the period covered by this quarterly report that materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II OTHER INFORMATION
Item
1. Legal Proceedings
We
are
currently not a party to any legal proceedings.
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 our annual
report on Form 10-K for the year ended December 31, 2006 but please
carefully consider both the risk factors of our annual report on Form 10-K
and
the risk factors below. The risk factors described below were previously
disclosed on the Form 10-K but have been updated to provide more recent
financial and factual information as of September 30, 2007.
Risks
Related to Our Business
We
expect to continue to operate at a loss and may never become
profitable.
Substantially all of our revenue since 2005 has been derived from collaborative
research and development agreements in connection with the development of our
potential product candidates including our collaborations with IAVI and Celladon
and our NIAID-funded subcontract with CHOP and NCH. We have incurred, and will
continue to incur for the foreseeable future, significant expense to develop
our
research and development programs, conduct preclinical studies and clinical
trials, seek regulatory approval for our product candidates and provide general
and administrative support for these activities. As a result, we have incurred
significant net losses since inception, and we expect to continue to incur
substantial additional losses in the future.
As
of
September 30, 2007, we had an accumulated deficit of $295.1 million. We may
never be able to commercialize our products or generate profits and, if we
do
become profitable, we may be unable to sustain or increase profitability.
Our
lead product candidate was placed on clinical hold and we do not currently
know
when or if the clinical trial of the product candidate will
resume.
On
July
20, 2007, we and the FDA placed a clinical hold on our Phase I/II clinical
trial
of tgAAC94, our inflammatory arthritis product candidate, after a patient
participating in the clinical trial experienced a serious adverse event, or
SAE.
This patient subsequently died and the cause of death is currently under
investigation.
In
September 2007, the National Institutes of Health Recombinant DNA Advisory
Committee held a public hearing which presented the preliminary evidence of
the
investigation. Preliminary experimental evidence and autopsy findings
presented at the hearing suggested that the subject died of an invasive fungal
infection. While we believe these data suggest it is unlikely that our
experimental inflammatory arthritis candidate contributed to the conditions
that
caused the death, we, the FDA or others may identify concerns that could cause
further delay or termination of the Phase I/II tgAAC94 clinical trial.
The investigation is ongoing and no assurance can be made that the FDA will
remove the hold or will allow us to continue the administration of tgAAC94
in
this study or in other future clinical studies. Any significant delay in
removing the clinical hold from this study, or an ultimate termination of this
study related to the clinical hold, would negatively impact our future operating
results and would likely result in a decrease in the trading price of our common
shares.
17
All
of our product candidates are in early-stage clinical trials or preclinical
development, and if we and our partners are unable to successfully develop
and
commercialize our product candidates we will be unable to generate sufficient
capital to maintain our business.
As
of July 2007, our congestive heart failure product candidate in collaboration
with Celladon is in a Phase I clinical trial, our inflammatory arthritis
candidate is in a Phase I/II trial, our HIV/AIDS product candidate in
collaboration with IAVI is in a Phase II trial and we have no product candidates
in Phase III trials. Of the trials that are currently being conducted, we will
not generate any product revenue, manufacturing revenue, revenue sharing or
royalties for at least several years, and then only if we can and/or our
partners 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. 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 marketing or 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.
Any
success of our clinical trials and preclinical studies may not be indicative
of
results in a large number of subjects of either safety or
efficacy.
The
successful results of our technology in preclinical studies using animal models
may not be predictive of the results that we will see in our clinical trials
with human subjects. In addition, results in early-stage clinical trials
generally test for drug safety rather than efficacy and are based on limited
numbers of subjects. Drug development involves a high degree of risk and our
reported progress and results from our early phases of clinical testing of
our
product candidates may not be indicative of progress or results that will be
achieved from larger populations, which could be less favorable. Moreover,
we do
not know if any favorable results we achieve in clinical trials will have a
lasting or repeatable effect. If a larger group of subjects does not experience
positive results or if any favorable results do not demonstrate a beneficial
effect, our product candidates that we advance to clinical trials may not
receive approval from the FDA for further clinical trials or commercialization.
For example, in March 2005, we discontinued the development of tgAAVCF, our
product candidate for the treatment of cystic fibrosis, following the analysis
of Phase II clinical trial data in which tgAAVCF failed to achieve the
efficacy endpoints of the trial.
If
we are unable to raise additional capital when needed, we will be unable to
conduct our operations and develop our potential
products.
Because
our 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.
|
Additional
sources of financing could involve one or more of the following:
• |
entering
into additional product development
collaborations;
|
18
• |
mergers
and acquisitions;
|
• |
issuing
equity in the public or private markets;
|
• |
extending
or expanding our current
collaborations;
|
• |
selling
or licensing our technology or product candidates;
|
• |
borrowing
under loan or equipment financing arrangements; and
|
• |
issuing
debt.
|
Additional
funding may not be available to us on reasonable terms, if at all. Our ability
to issue equity, and our ability to issue it at the current market price, may
be
adversely affected by the fact that we are presently ineligible under SEC rules
to utilize Form S-3 for primary offerings of our securities because the
aggregate market value of our outstanding common stock held by non-affiliates
is
less than $75.0 million.
The
perceived risk associated with the possible sale of a large number of shares
of
our common stock could cause some of our shareholders 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 collaborations 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.
Risks
Related to Our Common Stock
Concentration
of ownership of our common stock may give certain shareholders significant
influence over our business and may result in certain decisions that are
contrary to your interests.
A
small
number of investors own a significant number of shares of our common stock.
As
of September 30, 2007, Special Situations held approximately 2.6 million shares,
Biogen Idec held approximately 2.2 million shares, Orbimed Advisors LLC held
approximately 1.3 million shares and Elan held approximately 1.2 million shares,
of our common stock. Together these holdings represent approximately 37% of
our
common shares outstanding as of September 30, 2007. 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
|
• |
approval
of significant corporate transactions, such as a change of control
of
us.
|
The
interests of these shareholders may conflict with your interests or 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 us at a premium over the then-current market price of our common
stock, which could result in a decrease in our stock price and a reduction
in
the value of your investment.
Special
Situations, Biogen Idec and Elan have all 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 in
March 2004, Elan is only permitted to sell quantities of our stock equal to
175%
of the volume limitation set forth in Rule 144(e)(1) promulgated under the
Securities Act of 1933, as amended, subject to certain exceptions.
19
Item
2. Unregistered Sales of Securities and Use of Proceeds
Not
applicable.
Item
3. Defaults Upon Senior Securities
Not
applicable.
Item
4. Submission of Matters to a Vote of Security Holders
Not
applicable.
Item
5. Other Information
Not
applicable.
Item
6. Exhibits
See
accompanying
Exhibit
Index
included after
the
signature page of
this
quarterly
report
for a list of the exhibits filed or furnished with the
report.
20
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
Targeted
Genetics
Corporation
|
|
Date: October 31, 2007 |
By:
|
/s/ H.
Stewart Parker
|
|
|
H.
Stewart Parker,
President,
Chief Executive Officer and Director
(Principal
Executive Officer)
|
Date: October
31, 2007
|
By:
|
/s/ David
J. Poston
|
|
|
David
J. Poston,
Chief
Financial Officer
(Principal
Financial and Accounting
Officer)
|
21
INDEX
TO EXHIBITS
Exhibit
Number
|
|
Exhibit
Description
|
Form
|
Date
of
First
Filing
|
Exhibit
Number
|
Filed
Herewith
|
||||
3.1.1
|
Amended
and Restated Articles of Incorporation, dated May 9, 2006.
|
10-Q
|
8/7/07
|
3.1
|
||||||
3.1.2
|
Articles
of Amendment to the Restated Articles of Incorporation, dated May
17,
2007.
|
10-Q
|
8/7/07
|
3.1.2
|
||||||
3.2
|
Amended
and Restated Bylaws.
|
10-K
|
3/17/97
|
3.2
|
||||||
4.1
|
Registration
Rights Agreement among Targeted Genetics Corporation and certain
investors
dated as of January 8, 2007.
|
8-K
|
1/8/07
|
10.2
|
||||||
4.2
|
Registration
Rights Agreement among Targeted Genetics Corporation and certain
purchasers dated as of June 22, 2007.
|
8-K
|
6/22/07
|
10.2
|
||||||
10.1
|
Amendment
No. 3 to Exclusive Sublicense Agreement, dated as of March 9, 2007,
between Targeted Genetics and Alkermes, Inc. *
|
10-K
|
3/29/07
|
10.5(c)
|
||||||
10.2
|
Securities
Purchase Agreement among Targeted Genetics Corporation and certain
investors dated January 8, 2007.
|
8-K
|
1/8/07
|
10.1
|
||||||
10.3
|
Form
of Warrant to Purchase Shares of Common Stock of Targeted Genetics
Corporation dated January 11, 2007.
|
8-K
|
1/8/07
|
10.3
|
||||||
10.4
|
Securities
Purchase Agreement among Targeted Genetics Corporation and certain
purchasers dated as of June 22, 2007.
|
8-K
|
6/22/07
|
10.1
|
||||||
10.5
|
Form
of Common Stock Purchase Warrant of Targeted Genetics Corporation
dated as
of June 27, 2007.
|
8-K
|
6/22/07
|
10.3
|
||||||
10.6
|
Targeted
Genetics Corporation Stock Plan.
|
8-K
|
5/22/07
|
10.1
|
||||||
31.1
|
Certification
of Chief Executive Officer pursuant to Rules 13a-15(e) and 15d-15(e)
under
the Securities Exchange Act of 1934.
|
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.
|
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 this exhibit 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.
|
22