Armata Pharmaceuticals, Inc. - Quarter Report: 2007 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
|
||
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2007
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934 FOR THE TRANSITION PERIOD FROM _______________ TO
_______________
|
COMMISSION
FILE NUMBER: 0-23930
TARGETED
GENETICS CORPORATION
(EXACT
NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
Washington
|
91-1549568
|
(State
of Incorporation)
|
(I.R.S.
Employer Identification No.)
|
1100
Olive Way, Suite 100 Seattle, WA 98101
(Address
of principal executive offices)(Zip Code)
(206)
623-7612
(Registrant’s
telephone number, including area code)
______________________________________________________
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to the filing requirements
for
at least the past 90 days. Yes x
No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer” and “large accelerated filer” in Rule 12b-2 of the Exchange Act.
(check one):
Large
accelerated filer ¨ Accelerated
filer ¨ Non-accelerated
filer ý
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 May 1, 2007:
13,114,368
TARGETED
GENETICS CORPORATION
Quarterly
Report on Form 10-Q
For
the
quarter ended March 31, 2007
TABLE
OF
CONTENTS
|
|
|
|
Page No.
|
PART I
|
|
FINANCIAL
INFORMATION
|
|
|
|
|
|
|
|
Item 1.
|
|
Financial
Statements
|
|
|
|
|
|
|
|
a)
|
|
Condensed
Consolidated Balance Sheets at March 31, 2007 and December 31,
2006
|
|
1
|
b)
|
|
Condensed
Consolidated Statements of Operations for the three months ended
March 31,
2007 and 2006
|
|
2
|
c)
|
|
Condensed
Consolidated Statements of Cash Flows for the three months ended
March 31,
2007 and 2006
|
|
3
|
d)
|
|
Notes
to Condensed Consolidated Financial Statements
|
|
4
|
|
|
|||
Item
2.
|
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
9
|
|
|
|
|
|
Item
3.
|
|
Quantitative
and Qualitative Disclosures About Market Risk
|
|
14
|
Item
4T.
|
|
Controls
and Procedures
|
|
14
|
|
|
|
|
|
PART
II
|
|
OTHER
INFORMATION
|
|
|
|
|
|
|
|
Item
1.
|
|
Legal
Proceedings
|
|
15
|
Item
1A.
|
Risk
Factors
|
15
|
||
Item
2.
|
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
16
|
Item
3.
|
|
Defaults
Upon Senior Securities
|
|
17
|
Item
4.
|
|
Submission
of Matters to a Vote of Security Holders
|
|
17
|
Item
5.
|
|
Other
Information
|
|
17
|
Item
6.
|
|
Exhibits
|
|
17
|
|
|
|
|
|
SIGNATURES
|
|
18
|
||
INDEX
TO EXHIBITS
|
19
|
i
PART
I FINANCIAL INFORMATION
Item
1. Financial
Statements
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
March
31,
|
December
31,
|
||||||
2007
|
2006
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
11,254,000
|
$
|
6,206,000
|
|||
Accounts
receivable
|
944,000
|
1,498,000
|
|||||
Prepaid
expenses and other
|
340,000
|
531,000
|
|||||
Total
current assets
|
12,538,000
|
8,235,000
|
|||||
Property
and equipment, net
|
951,000
|
1,100,000
|
|||||
Goodwill
|
7,926,000
|
7,926,000
|
|||||
Other
assets
|
203,000
|
206,000
|
|||||
Total
assets
|
$
|
21,618,000
|
$
|
17,467,000
|
|||
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
2,213,000
|
$
|
1,901,000
|
|||
Accrued
employee expenses
|
561,000
|
861,000
|
|||||
Accrued
restructure charges
|
1,831,000
|
1,046,000
|
|||||
Deferred
revenue
|
93,000
|
251,000
|
|||||
Current
portion of long-term obligations
|
1,114,000
|
1,129,000
|
|||||
Total
current liabilities
|
5,812,000
|
5,188,000
|
|||||
Accrued
restructure charges and deferred rent
|
5,396,000
|
6,342,000
|
|||||
Long-term
obligations
|
569,000
|
570,000
|
|||||
Commitments
and Contingencies
|
|||||||
Shareholders’
equity:
Preferred
stock, $0.01 par value, 600,000 shares authorized:
|
|||||||
Series
A preferred stock, 180,000 shares designated, none issued and
outstanding
|
—
|
—
|
|||||
Common
stock, $0.01 par value, 18,000,000 shares authorized, 13,109,902
shares
issued and outstanding at March 31, 2007 and 10,921,736 shares issued
and
outstanding at December 31, 2006
|
131,000
|
109,000
|
|||||
Additional
paid-in capital
|
297,572,000
|
289,324,000
|
|||||
Accumulated
deficit
|
(287,862,000
|
)
|
(284,027,000
|
)
|
|||
Accumulated
other comprehensive loss
|
—
|
(39,000
|
)
|
||||
Total
shareholders’ equity
|
9,841,000
|
5,367,000
|
|||||
Total
liabilities and shareholders’ equity
|
$
|
21,618,000
|
$
|
17,467,000
|
See
accompanying notes to condensed consolidated financial statements
1
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three
months ended
March
31,
|
|||||||
2007
|
2006
|
||||||
Revenue
under collaborative agreements
|
$
|
1,661,000
|
$
|
2,430,000
|
|||
Operating
expenses:
|
|||||||
Research
and development
|
3,696,000
|
3,677,000
|
|||||
General
and administrative
|
1,552,000
|
1,481,000
|
|||||
Restructure
charges
|
184,000
|
1,042,000
|
|||||
Total
operating expenses
|
5,432,000
|
6,200,000
|
|||||
Loss
from operations
|
(3,771,000
|
)
|
(3,770,000
|
)
|
|||
Investment
income (loss)
|
(65,000
|
)
|
151,000
|
||||
Interest
expense
|
—
|
(113,000
|
)
|
||||
Net
loss
|
$
|
(3,836,000
|
)
|
$
|
(3,732,000
|
)
|
|
Net
loss per common share (basic and diluted)
|
$
|
(0.30
|
)
|
$
|
(0.42
|
)
|
|
Shares
used in computation of basic and diluted net loss per common
share
|
12,865,000
|
8,869,000
|
See
accompanying notes to condensed consolidated financial statements
2
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Three
months ended
|
|||||||
March
31,
|
|||||||
|
2007
|
2006
|
|||||
Operating
activities:
|
|||||||
Net
loss
|
$
|
(3,836,000
|
)
|
$
|
(3,732,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
|
144,000
|
168,000
|
|||||
Stock-based
compensation
|
184,000
|
221,000
|
|||||
Loss
(gain) on investments
|
207,000
|
(5,000
|
)
|
||||
Changes
in assets and liabilities:
|
|||||||
Decrease
(increase) in accounts receivable
|
554,000
|
(611,000
|
)
|
||||
Decrease
in prepaid expenses and other
|
12,000
|
78,000
|
|||||
Decrease
in other assets
|
3,000
|
2,000
|
|||||
Increase
in current liabilities
|
13,000
|
49,000
|
|||||
Increase
(decrease) in deferred revenue
|
(158,000
|
)
|
472,000
|
||||
Increase
(decrease) in accrued restructure expenses and deferred
rent
|
(161,000
|
)
|
482,000
|
||||
Net
cash used in operating activities
|
(3,038,000
|
)
|
(2,876,000
|
)
|
|||
Investing
activities:
|
|||||||
Purchases
of property and equipment
|
—
|
(32,000
|
)
|
||||
Proceeds
from sale of investments
|
16,000
|
36,000
|
|||||
Net
cash provided by investing activities
|
16,000
|
4,000
|
|||||
Financing
activities:
|
|||||||
Net
proceeds from sales of capital stock (and warrants)
|
8,058,000
|
4,797,000
|
|||||
Proceeds
from the exercise of stock options
|
28,000
|
6,000
|
|||||
Payments
under leasehold improvements and equipment financing
arrangements
|
(16,000
|
)
|
(55,000
|
)
|
|||
Net
cash provided by financing activities
|
8,070,000
|
4,748,000
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
5,048,000
|
1,876,000
|
|||||
Cash
and cash equivalents, beginning of period
|
6,206,000
|
14,122,000
|
|||||
Cash
and cash equivalents, end of period
|
$
|
11,254,000
|
$
|
15,998,000
|
|||
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 months ended March 31,
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.
In
May
2006, our Board of Directors approved a 1-for-10 reverse stock split, which
became effective on May 11, 2006. All references to common stock, common shares
outstanding, average number of common shares outstanding, per share amounts
and
options in these financial statements and notes to financial statements have
been restated to reflect the 1-for-10 common stock reverse split on a
retroactive basis.
Our
combined cash and cash equivalents totaled $11.3 million at March 31, 2007.
We
believe that our current resources, including the capital raised in January
2007
and the cash anticipated to be received from our collaborative partners, are
sufficient to fund our planned operations, including our clinical trials, into
the fourth quarter of 2007. This
estimate is based on our ability to perform planned research and development
activities and the receipt of planned funding from our collaborators.
Our
near-term financing strategy includes leveraging our development capabilities
and intellectual property assets into additional 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 to reflect
the
possible future effects on the recoverability and classification of assets
or
the amounts and classifications of liabilities that may result from the outcome
of the uncertainty related to our ability to continue as a going
concern.
Accounting
for Uncertainties in Income Taxes
4
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.
2. Long-Term
Obligations
Long-term
obligations consist of the following:
|
March
31,
|
December
31,
|
|||||
2007
|
|
2006
|
|||||
Loans
payable to Biogen Idec
|
$
|
1,672,000
|
$
|
1,672,000
|
|||
Equipment
financing obligations
|
11,000
|
27,000
|
|||||
Total
obligations
|
1,683,000
|
1,699,000
|
|||||
Less
current portion
|
(1,114,000
|
)
|
(1,129,000
|
)
|
|||
Total
long-term obligations
|
$
|
569,000
|
$
|
570,000
|
As
of
March 31, 2007, we owed $1.7 million to Biogen Idec, a beneficial owner of
approximately 16.6% of our outstanding common shares, which is the remaining
debt owed to Biogen Idec. As part of a 2006 restructuring, we agreed to terms
that resulted in the remaining $1.7 million, which consists of $1.5 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 on August
1,
2007 and the remaining balance on August 1, 2008. In 2006, we also agreed to
accelerate repayment of the 2007 installment and repay that portion within
thirty days of a change in control of the company. We must apply one-third
of
certain up-front payments received from potential future corporate
collaborations to the outstanding balance on this loan payable, first to
repayment of any accrued and unpaid interest on the principal being repaid,
and
second to the repayment of outstanding principal in reverse order of maturity.
Outstanding borrowings under this unsecured loan agreement bear interest at
the
one-year London Interbank Offered Rate, or LIBOR, plus 1%, which is reset
quarterly. Since the estimated future interest payments are included in the
balance of the obligation, we will not incur further interest charges
attributable to this debt. The loan contains financial covenants that limit
our
ability to declare or pay cash dividends.
Future
aggregate principal payments related to the Biogen Idec debt are $1.0 million
in
2007, $525,000 in 2008 and zero in 2009, 2010 and 2011.
3. Accrued
Restructure Charges
We
apply
the provisions of SFAS No. 146, “Accounting
for Costs Associated with Exit or Disposal Activities,” as
it
relates to our facility in Bothell, Washington and record restructure charges
on
the operating lease for the facility as a result of our 2003 decision to
discontinue use of the facility. Accrued restructure charges represent our
best
estimate of the fair value of the liability as determined under SFAS No. 146
and
are computed as the fair value of the difference between the remaining lease
payments, net of assumed sublease income and expense. We also record accretion
expense based upon changes in the accrued liability that results from the
passage of time at an assumed discount rate of 10%. Accretion expense is
recorded on an ongoing basis through the end of the lease term in September
2015
and is reflected as a restructuring charge in the accompanying consolidated
statements of operations.
The
table
below presents a reconciliation of the accrued restructure liability for the
three month period ended March 31, 2007:
Contract
Termination Costs
|
||||
December
31, 2006 accrued liability
|
$
|
7,377,000
|
||
Adjustments
to the liability (accretion)
|
184,000
|
|||
Amount
paid
|
(345,000
|
)
|
||
March
31, 2007 accrued liability
|
$
|
7,216,000
|
5
Adjustments
to the accrued restructure liability for the three months ended March 31, 2007
reflect $184,000 of accretion expense for the period. This adjustment to the
liability is reflected as restructure charges in the accompanying condensed
consolidated statement of operations.
Through
March 31, 2007, we have recorded contract termination costs totaling $10.2
million for our Bothell facility. We expect to incur an additional $2.8 million
in accretion expense through the expiration of the Bothell lease in September
2015.
We
periodically evaluate our restructuring estimates and assumptions and record
additional restructure charges as necessary. Because restructure charges are
estimates based upon assumptions regarding the timing and amounts of future
events, significant adjustments to the accrual may be necessary in the future
based on the actual outcome of events and as we become aware of new facts and
circumstances.
4.
Equity
Financing
On
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. These
warrants expire in January 2012 and are exercisable at $5.41 per share beginning
July 19, 2007. We also issued a warrant to purchase approximately 16,000 shares
of our common stock as compensation to the placement agent in this transaction.
Stock
Compensation
We
have
various stock option plans, or Option Plans, that provide for the issuance
of
nonqualified and incentive stock options to acquire up to 1,297,944 shares
of
our common stock. These stock options may be granted by our Board of Directors
to our employees, directors and officers and to consultants, agents, advisors
and independent contractors who provide services to us. The exercise price
for
incentive stock options must not be less than the fair market value of the
shares on the date of grant. Options granted under our Option Plans expire
no
later than ten years from the date of grant and generally vest and become
exercisable over a four-year period following the date of grant. In 2003, as
part of an employee retention plan, we granted options to purchase 65,500 shares
of our common stock with accelerated vesting periods which ranged from twelve
to
eighteen months. In 2006, also 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. Every non-employee member of our Board of Directors
receives an annual nonqualified stock option grant and these options vest over
a
twelve-month period provided the grantee continues service to us. Upon the
exercise of stock options, we issue new shares from shares reserved for issuance
under our Option Plans.
Effective
January 2006, we adopted SFAS No. 123R, “Share-Based
Payment.”
SFAS No.
123R requires us to expense the fair value of stock options granted over the
vesting period. We have recognized compensation expense of $184,000 for the
three months ended March 31, 2007 and $221,000 for the three months ended March
31, 2006. This compensation expense includes: (a) compensation cost for all
share-based stock options granted prior to, but not yet vested as of January
1,
2006, based on the grant-date fair value used for prior pro forma disclosures
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. For the first quarter ended March 31, 2007, we
classified $95,000 as research and development expense and $89,000 as general
and administrative expense. As of March 31, 2007, total unrecognized
compensation cost related to unvested options was approximately $463,000, net
of
estimated forfeitures, which we expect to recognize over a weighted average
period of approximately 7 months.
6
Following
is a summary of stock option activity and related prices for the quarter ended
March 31, 2007:
|
Shares
|
Weighted
Average
Exercise
Price
|
Remaining
Average
Contractual
Term
(Years)
|
Intrinsic
Value
|
|||||||||
Outstanding,
December 31, 2006
|
835,085
|
$
|
15.39
|
||||||||||
Granted
|
8,400
|
3.88
|
|||||||||||
Exercised
|
(8,166
|
)
|
3.44
|
||||||||||
Expired
|
(9,726
|
)
|
47.50
|
||||||||||
Forfeited
|
(27,586
|
)
|
9.16
|
||||||||||
Outstanding,
March 31, 2007
|
798,007
|
$
|
15.21
|
7.00
|
$
|
403,000
|
|||||||
Exercisable,
March 31, 2007
|
597,286
|
$
|
17.98
|
6.49
|
$
|
264,000
|
The
aggregate intrinsic value is determined using the closing price of our common
stock of $3.71 on March 31, 2007. The intrinsic value of stock options exercised
was $13,000 during the three months ended March 31, 2007 and was $1,000 during
the three months ended March 31, 2006. We received $28,000 from the exercise
of
stock options for the three months ended March 31, 2007.
Stock
options outstanding and exercisable as of March 31, 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
|
108,699
|
$
|
2.46
|
8.90
|
71,330
|
$
|
2.55
|
|||||||||
3.80 - 3.80
|
187,000
|
3.80
|
9.19
|
129,750
|
3.80
|
|||||||||||
3.99 - 9.10
|
162,285
|
7.43
|
7.50
|
101,767
|
7.18
|
|||||||||||
10.80
- 14.90
|
160,084
|
13.10
|
6.79
|
116,904
|
13.10
|
|||||||||||
15.30 - 148.80
|
179,939
|
43.68
|
3.31
|
177,535
|
43.96
|
|||||||||||
Balance,
March 31, 2007
|
798,007
|
$
|
15.21
|
7.00
|
597,286
|
$
|
17.98
|
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 was $3.05 per share for the
first
quarter 2007 and $3.67 for the first quarter 2006. The
following are the weighted average assumptions for the periods
noted:
Three
Months ended March 31,
|
|||||||
2007
|
2006
|
||||||
Expected
dividend rate
|
Nil
|
Nil
|
|||||
Expected
stock price volatility
|
1.047
- 1.095
|
1.086
|
|||||
Risk-free
interest rate range
|
4.56
- 4.58
|
%
|
4.25
|
%
|
|||
Expected
life of options
|
4
- 5 years
|
5
years
|
Expected
Dividend: We
do not
anticipate any dividends based on our current dividend restrictions related
to
our Biogen Idec note.
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.
7
Forfeiture
Rate: We
apply
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 additional adjustments to compensation expense in
future periods.
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
March
31,
|
|||||||
|
2007
|
2006
|
|||||
Net
loss as reported
|
$
|
(3,836,000
|
)
|
$
|
(3,732,000
|
)
|
|
Other
comprehensive income:
|
|||||||
Unrealized
gain on available-for-sale securities
|
—
|
8,000
|
|||||
Foreign
currency translation adjustment
|
—
|
16,000
|
|||||
Other
comprehensive loss
|
$
|
(3,836,000
|
)
|
$
|
(3,708,000
|
)
|
6.
Investments
As
of
March 31, 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 three months ended March 31,
2007, we sold 100,000 shares resulting in a realized gain of
$1,000.
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.
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 quarter of 2007,
due
to the
declining market value of the Chromos securities and a decline in Chromos’
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 March 31, 2007 and recognized a realized loss of
$208,000.
Fair
Value
|
Unrealized
Loss
|
Proceeds
from the sale of securities
|
Realized
Loss
|
||||||||||
Marketable
equity securities
|
$
|
133,000
|
$
|
—
|
$
|
16,000
|
$
|
(207,000
|
)
|
7.
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 quarter ended March
31, 2007.
Historically,
we have not incurred any interest or penalties associated with tax matters
and
no interest or penalties were recognized during the three months ended March
31,
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 1992 to 2002 may be subject to examination in the
event
that we utilize the NOLs from those years in our current or future year tax
returns.
8
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
Forward-Looking
Statements
This
quarterly report on Form 10-Q contains forward-looking statements that involve
risks and uncertainties. Forward-looking statements include statements about
our
product development and commercialization goals and expectations, potential
market opportunities, our plans for and anticipated results of our clinical
development activities and the potential advantage of our product candidates,
our future cash requirements and the sufficiency of our cash and cash
equivalents to meet these requirements, our ability to raise capital when needed
and other statements that are not historical facts. Words such as “may,” “will,”
“believes,” “estimates,” “expects,” “anticipates,” “plans” and “intends,” or
statements concerning “potential” or “opportunity” and other words of similar
meaning or the negative thereof, may identify forward-looking statements, but
the absence of these words does not mean that 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 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. In addition, 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. A new class of gene
therapeutics currently receiving attention is RNA interference or RNAi. RNAi
comprises small RNA molecules that once delivered into the cell may shut down
or
interfere with cellular functions. The vectors developed by us for delivery
of
genes may be particularly useful for the delivery of this new class of genetic
therapeutics.
We
are
primarily focused on the following product development programs:
Description
|
Indication
|
Funding
Partner
|
Development
Status
|
|||
AAV
delivery of TNF-alpha antagonist (tgAAC94)
|
Inflammatory
Arthritis
|
Self
funded
|
Phase
I/II
|
|||
AAV
delivery of HIV antigens (tgAAC09)
|
HIV/AIDS
|
IAVI
|
Phase
II
|
|||
AAV
delivery of HIV antigens (HVDDT)
|
HIV/AIDS
|
NIAID
|
Preclinical
|
|||
AAV
delivery of SERCA2a
|
Congestive
Heart Failure
|
Celladon
|
Preclinical
|
|||
AAV
expression of htt shRNA (RNAi)
|
Huntington’s
disease
|
Sirna
Therapeutics
|
Preclinical
|
Most
of
our 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. We have financed the company
primarily through proceeds from public and private sales of our equity
securities, through cash payments received from our collaborative partners
for
product development and manufacturing activities, and through proceeds from
the
issuance of debt and loan funding under equipment financing arrangements. 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 approximately 16,000 shares of our common stock
as
compensation to the placement agent in this transaction.
9
As
of
March 31, 2007, our accumulated deficit totaled $287.9 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.
We
will
require access to significantly higher amounts of capital than we currently
have
in order to successfully develop our lead inflammatory arthritis product
candidate or our partnered product candidates. We may be unable to obtain
required funding when needed or on acceptable terms, obtain or maintain
corporate partnerships, or complete acquisition transactions necessary or
desirable to complete the development of our product candidates.
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 below have been updated to provide more recent financial and factual
information as of March 31, 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 quarter ended March 31, 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
decreased to $1.7 million for the three months ended March 31, 2007 as compared
to $2.4 million for the same period in 2006. The decrease in revenue reflects
lower research and development activities under our collaboration with
the
International AIDS Vaccine Initiative, or IAVI, and
Celladon Corporation, or Celladon, partially offset by an increase in research
and development activities under the National Institute of Allergy and
Infectious Diseases, or NIAID, funded HIV/AIDS vaccine project in collaboration
with the Children’s Hospital of Philadelphia, or CHOP, and the Columbus
Children’s Research Institute, or CCRI. We expect that our revenue for the
remainder of 2007 will consist primarily of research and development revenue
earned from the NIAID-funded HIV/AIDS project and 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 remained consistent at $3.7 million for the three
months ended March 31, 2007 and 2006. Costs related to our inflammatory
arthritis program increased due to higher clinical trial activity and a higher
number of enrolled subjects. 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 as the project has progressed into clinical testing.
Research and preclinical development program expenses decreased due to modestly
less research and development activity related to our congestive heart failure
collaboration with Celladon. We expect that our research and development
expenses for the remainder of 2007 will vary depending on the timing of outside
services necessary to support our clinical programs, our collaboration with
Celladon and our subcontract with CCRI and CHOP in support of the NIAID HIV/AIDS
vaccine project.
10
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
March
31,
|
|||||||
|
2007
|
2006
|
|||||
Programs
in clinical development:
|
|||||||
Inflammatory
arthritis
|
$
|
762,000
|
$
|
558,000
|
|||
IAVI
HIV/AIDS vaccine
|
109,000
|
317,000
|
|||||
Indirect
costs and other
|
522,000
|
347,000
|
|||||
Total
clinical development program expense
|
1,393,000
|
1,222,000
|
|||||
Research
and preclinical development program expense
|
2,303,000
|
2,455,000
|
|||||
Total
research and development expense
|
$
|
3,696,000
|
$
|
3,677,000
|
Research
and development costs attributable to programs in clinical development include
the costs of salaries and benefits, clinical trial costs, outside services,
materials and supplies incurred to support the clinical programs. Indirect
costs
allocated to clinical programs include facility and occupancy costs, research
and development administrative costs, and license and royalty payments. These
costs are further allocated between clinical and preclinical programs based
on
relative levels of program activity. IAVI separately manages and funds the
clinical trial costs of our 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 under a subcontract with CHOP and CCRI and
the
congestive heart failure programs as well as other programs prior to their
transition into clinical trials. Research and preclinical program expense also
includes costs that are not allocable to a clinical development program, such
as
unallocated manufacturing infrastructure costs. Because we conduct multiple
research projects and utilize resources across several programs, our research
and preclinical development costs are not directly assigned to individual
programs.
For
purposes of reimbursement from our collaboration partners, we capture the level
of effort expended on a program through our project management system, which
is
based primarily on human resource time allocated to each program, supplemented
by an allocation of indirect costs and other specifically identifiable costs,
if
any. As a result, the costs allocated to programs identified in the table above
do not necessarily reflect the actual costs of the program.
General
and Administrative Expenses. General
and administrative expenses increased to $1.6 million for the three months
ended
March 31, 2007 from $1.5 million for the same period in 2006. This increase
reflects higher patent charges and compensation expense partially offset by
lower audit fees.
Restructure
Charges. Restructure
charges decreased to $184,000 for the three months ended March 31, 2007 compared
to $1.0 million for the same period in 2006. Restructuring charges in 2006
include charges of $639,000 related to changes in our expectations regarding
market conditions for the Bothell facility subleasing market and $219,000
related to employee termination benefits of our restructuring efforts to realign
our cost structure. Restructuring charges also include accretion expense of
$184,000 in both the three months ended March 31, 2007 and 2006.
Other
Income and Expense
Investment
Income (Loss).
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 decreased to a loss of $65,000 for the three
months ended March 31, 2007 compared to income of $151,000 for the same period
in 2006. For the three month period ended March 31, 2007, also investment income
reflects a $208,000 realized loss related to an other-than-temporary impairment
loss on our investment in Chromos due to the declining market value of the
Chromos securities combined with decline in Chromos’ financial
position.
Interest
Expense.
Interest expense decreased to zero for the three months ended March 31, 2007,
compared to $113,000 for the same period in 2006. 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 $1.7 million carrying value
of the remaining debt includes the related estimated future interest payments
and accordingly, we did not record interest expense on the Biogen Idec expense
in the three months ended March 31, 2007. We do not expect to record future
interest expense on this restructured debt.
11
Liquidity
and Capital Resources
We
had
cash and cash equivalents balances of $11.3 million at March 31, 2007 compared
to $6.2 million at December 31, 2006. Our cash and cash equivalents
increased in the three months ended March 31, 2007 primarily reflecting the
net
proceeds of $8.1 million from our January 2007 sale of our common stock and
warrants partially offset by our net loss and the resulting cash used in
operations of $3.0 million.
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 approximately 16,000 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 HIV/AIDS vaccine candidate
for
the developing world and our inflammatory arthritis product candidate are both
in clinical trials. We expect to continue incurring significant expense in
advancing our 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 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 and fund
our ongoing operating costs, we also have significant lease commitments,
long-term obligations and outstanding debt that draw on our cash resources.
Our
most significant obligations are approximately $12.9 million of remaining
Bothell facility lease payments, which we are obligated to pay at $1.4 million
to $1.6 million per year until the year 2015 and $1.5 million of aggregate
principal payments to Biogen Idec under an outstanding loan payable. Under
our
2006 modified loan agreement with Biogen Idec, the
$1.5
million principal balance bears interest at the rate of LIBOR plus 1% and we
agreed to repay $1.0 million on August 1, 2007 and the remaining balance on
August 1, 2008. In addition, the agreement provides for early repayment of
the
2007 installment within thirty days of a change in control of the company.
The
Biogen Idec loan agreement includes a provision that requires us to apply
one-third of certain up-front payments received from potential future corporate
collaborations to the outstanding balance on this loan payable.
We
will
need to raise additional capital to make the scheduled payments and to repay
these notes.
We
expect
the level of our future operating expenses to be driven by the needs of our
product development programs, our debt obligations and our lease obligations
offset by the availability of funds through equity offerings, partner-funded
collaborations or other financing or business development activities. The size,
scope and pace of our product development activities depend on the availability
of these resources. Our future cash requirements will depend on many factors,
including:
· |
the
rate and extent of scientific progress in our research and development
programs;
|
· |
the
timing, costs and scope of, and our success in, conducting clinical
trials, obtaining regulatory approvals and pursuing patent
prosecutions;
|
· |
competing
technological and market developments;
|
· |
the
timing and costs of, and our success in, any product commercialization
activities and facility expansions, if and as required;
and
|
· |
the
existence and outcome of any litigation or administrative proceedings
involving intellectual property.
|
We
have
financed our product development activities and general corporate functions
primarily through proceeds from public and private sales of our equity
securities, through cash payments received from our collaborative partners
and
proceeds from the issuance of debt. To a lesser degree, we have also financed
our operations through interest earned on cash and cash equivalents, loan
funding under equipment financing agreements and research grants. These
financing sources have historically allowed us to maintain adequate levels
of
cash and cash equivalents.
12
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 our collaboration with CHOP and CCRI
through a subcontract with the NIAID. To date we have received $1.6 million
under this subcontract and our portion of the remaining project funding could
be
up to an additional $16.6 million over the remaining four years of the contract.
The funding is awarded to us in annual installments based on an approved work
plan and achievement of milestones.
The
funding from each of our collaborative partners fully offsets our incremental
program costs caused by each collaboration and generally also partially funds
development of our company-funded inflammatory arthritis product candidate
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
revenue from our collaborative partners 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
collaborative funding expected from the NIAID, Celladon or IAVI collaborations
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. In the biotechnology industry, there
is a
low level of success in clinical trials and our ability to raise capital depends
in part on clinical trial success.
We
are
currently evaluating additional sources of financing that could involve one
or
more of the following:
· |
entering
into additional product development
collaborations;
|
· |
mergers
and acquisitions;
|
· |
issuing
equity in the public or private markets;
|
· |
extending
or expanding our current
collaborations;
|
· |
selling
or licensing our technology or product candidates;
|
· |
borrowing
under loan or equipment financing arrangements;
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 $13
million to $16 million and that our cash and cash equivalents at March 31,
2007,
plus the anticipated funding from our product development collaborations and
contracts will be sufficient to fund our operations into the fourth quarter
of
2007. This estimate is based on our ability to perform planned research and
development activities and the receipt of planned funding from our
collaborators.
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.
13
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
Items
with interest rate risk:
· Short
term investments:
Because
of the short-term nature of our investments, we believe that our exposure to
market rate fluctuations on our investments is minimal. Currently, we do not
use
any derivative or other financial instruments or derivative commodity
instruments to hedge any market risks and do not plan to employ these
instruments in the future. At March 31, 2007, we held $11.3 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%
change in short-term interest rates from those in effect at March 31, 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%. In 2006, in connection with the restructuring of this debt we accrued
estimated remaining future interest payments of $167,000 on the promissory
note
at a rate of 6.33%. 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 March 31, 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
|
$
|
1,000,000
|
$
|
525,000
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
1,525,000
|
Items
with market and foreign currency exchange risk:
· Investment
in Chromos Molecular Systems, Inc.:
At March
31, 2007, we held 2.4 million shares of Chromos common shares with a market
value of $0.065 per common share as quoted by the Toronto Stock Exchange and
denominated in Canadian dollars. As of March 31, 2007 the Canadian dollar to
US
dollar exchange rate was US $0.8655 per CA $1.00. As of March 31, 2007, this
investment is recorded at $133,000 and is classified within prepaid expenses
and
other. We recorded a realized loss of $208,000 in the quarter ended March 31,
2007 due to an other-than-temporary impairment resulting from a decline in
market value of the Chromos securities combined with decline in Chromos’
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 three months ended
March 31, 2007, we recorded $1,000 of net 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.
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.
14
None.
Item
1A. Risk Factors
Other
than with respect to the risk factors below, there have been no material changes
from the risk factors disclosed in “Section 1A. Risk Factors” of our annual
report on Form 10-K for the year ended December 31, 2006. The risk factors
below were disclosed on the Form 10-K and have been updated to provide more
recent financial and factual information as of March 31, 2007.
Risks
Related to Our Business
The
audit report prepared by our independent registered public accounting firm
relating to our financial statements for the year ended December 31, 2006
includes an explanatory paragraph expressing substantial doubt about our ability
to continue as a going concern.
We
estimate that our cash and cash equivalents on hand, plus expected funding
from
our partners, will be sufficient to fund our operations into the fourth quarter
of 2007. This estimate is based on our ability to perform planned research
and
development activities and the receipt of expected funding from our partners.
Prior to that time, we will need to raise additional capital to continue to
fund
operations at their current level. In addition, as of March 31, 2007, we owed
to
Biogen Idec approximately $1.5 million in aggregate principal amount pursuant
to
an outstanding promissory note.
If
we do
not raise additional funds, we would be forced to preserve our cash position
through a combination of additional 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 significantly dilutive to our shareholders. We may need to augment
our
cash through additional and possibly repetitive dilutive financings. If we
are
unable to raise additional funds, we could be forced to discontinue our
operations.
If
we are unable to raise additional capital when needed, we will be unable to
conduct our operations and develop our potential
products.
Because
internally generated cash flow will not fund development and commercialization
of our product candidates, we will require substantial additional financial
resources. Our future capital requirements will depend on many factors,
including:
· | the rate and extent of scientific progress in our research and development programs; |
· |
the
timing, costs and scope of, and our success in, conducting clinical
trials, obtaining regulatory approvals and pursuing patent
prosecutions;
|
· | competing technological and market developments; |
· |
the
timing and costs of, and our success in, any product commercialization
activities and facility expansions, if and as required;
and
|
· | the existence and outcome of any litigation or administrative proceedings involving intellectual property. |
Additional
sources of financing could involve one or more of the following:
· |
entering
into additional product development
collaborations;
|
· | mergers and acquisitions; |
· | issuing equity in the public or private markets; |
· | extending or expanding our current collaborations; |
15
· | 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. 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.
We
expect to continue to operate at a loss and may never become
profitable.
Substantially all of our revenue to date has been derived under collaborative
research and development agreements relating to the development of our potential
product candidates. We have incurred, and will continue to incur for the
foreseeable future, significant expense to develop our research and development
programs, conduct preclinical studies and clinical trials, seek regulatory
approval for our product candidates and provide general and administrative
support for these activities. As a result, we have incurred significant net
losses since inception, and we expect to continue to incur substantial
additional losses in the future. As of March 31, 2007, we had an accumulated
deficit of $287.9 million. We may never generate profits and, if we do
become profitable, we may be unable to sustain or increase profitability.
All
of our product candidates are in early-stage clinical trials or preclinical
development, and if we are unable to successfully develop and commercialize
our
product candidates, we will be unable to generate sufficient capital to maintain
our business.
In
March 2006, we initiated a Phase I/II trial for our inflammatory arthritis
product candidate in the United States and Canada. We will not generate any
product revenue for at least several years and then only if we can successfully
develop and commercialize our product candidates. Commercializing our potential
products depends on successful completion of additional research and development
and testing, in both preclinical development and clinical trials. Clinical
trials may take several years or more to complete. The commencement, cost and
rate of completion of our clinical trials may vary or be delayed for many
reasons. If we are unable to successfully complete preclinical and clinical
development of some or all of our product candidates in a timely manner, we
may
be unable to generate sufficient product revenue to maintain our
business.
Even if our potential products succeed in clinical trials and are approved
for
marketing, these products may never achieve market acceptance. If we are
unsuccessful in commercializing our product candidates for any reason, including
greater effectiveness or economic feasibility of competing products or
treatments, the failure of the medical community or the public to accept or
use
any products based on gene delivery, inadequate marketing and distribution
capabilities or other reasons discussed elsewhere in this section, we will
be
unable to generate sufficient product revenue to maintain our
business.
Our
loan
agreement with Biogen Idec contains financial covenants establishing limits
on
our ability to declare or pay cash dividends.
16
None.
None.
None.
See
the
Index to Exhibits included in this quarterly report.
17
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
TARGETED
GENETICS
CORPORATION
|
||
|
|
|
Date:
May 9, 2007
|
By: |
/s/ H.
STEWART
PARKER
|
H.
Stewart Parker,
President,
Chief Executive Officer and Director
(Principal
Executive Officer)
|
Date:
May 9, 2007
|
By: |
/s/ DAVID
J.
POSTON
|
David
J. Poston,
Chief
Financial Officer
(Principal
Financial and Accounting
Officer)
|
18
INDEX
TO EXHIBITS
Incorporated
by Reference
|
||||||||||
Exhibit
Number
|
Exhibit
Description
|
Form
|
Date
of First Filing
|
Exhibit
Number
|
Filed
Herewith
|
|||||
3.1
|
Amended
and Restated Articles of Incorporation
|
8-K
|
5/12/06
|
3.1
|
||||||
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
|
||||||
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
|
||||||
31.1
|
Certification
of Chief Executive Officer pursuant to Rules 13a-15(e) and 15d-15(e)
under
the Securities Exchange Act of 1934, as amended
|
X
|
||||||||
31.2
|
Certification
of Chief Financial Officer pursuant to Rules 13a-15(e) and 15d-15(e)
under
the Securities Exchange Act of 1934, as amended
|
X
|
||||||||
32.1
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||
32.2
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
X
|
*
|
Portions
of this exhibit have been omitted based on a grant of confidential
treatment from the SEC. The omitted portions of this exhibit have
been
filed separately with the SEC.
|
19