Armata Pharmaceuticals, Inc. - Quarter Report: 2006 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, 2006
|
|
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 ý Non-accelerated
filer ¨
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). o
Yes
x
No
Shares
of
Common Stock, par value $0.01 per share, outstanding as of May 1, 2006:
98,519,355
TARGETED
GENETICS CORPORATION
Quarterly
Report on Form 10-Q
For
the
quarter ended March 31, 2006
TABLE
OF
CONTENTS
|
|
|
|
Page No.
|
PART I
|
|
FINANCIAL
INFORMATION
|
|
|
|
|
|
|
|
Item 1.
|
|
Financial
Statements
|
|
|
|
|
|
|
|
a)
|
Condensed Consolidated Balance Sheets at March 31, 2006 and December 31, 2005 |
1
|
||
b)
|
Condensed
Consolidated Statements of Operations for the three months ended
March 31,
2006 and 2005
|
2
|
||
c)
|
Condensed
Consolidated Statements of Cash Flows for the three months ended
March 31,
2006 and 2005
|
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
4.
|
|
Controls
and Procedures
|
|
15
|
|
|
|
|
|
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
|
|
17
|
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
|
|||
EXHIBIT
INDEX
|
19
|
i
PART
I FINANCIAL INFORMATION
Item
1. Financial
Statements
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
March
31,
|
December
31,
|
||||||
2006
|
2005
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
15,998,000
|
$
|
14,122,000
|
|||
Accounts
receivable
|
991,000
|
380,000
|
|||||
Prepaid
expenses and other
|
619,000
|
683,000
|
|||||
Total
current assets
|
17,608,000
|
15,185,000
|
|||||
Property
and equipment, net
|
1,611,000
|
1,747,000
|
|||||
Goodwill
|
31,649,000
|
31,649,000
|
|||||
Other
assets
|
215,000
|
217,000
|
|||||
Total
assets
|
$
|
51,083,000
|
$
|
48,798,000
|
|||
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
1,840,000
|
$
|
1,770,000
|
|||
Accrued
employee expenses
|
566,000
|
587,000
|
|||||
Accrued
restructure charges
|
645,000
|
1,838,000
|
|||||
Deferred
revenue
|
750,000
|
278,000
|
|||||
Current
portion of long-term obligations
|
116,000
|
155,000
|
|||||
Total
current liabilities
|
3,917,000
|
4,628,000
|
|||||
Accrued
restructure charges and deferred rent
|
7,097,000
|
5,422,000
|
|||||
Long-term
obligations
|
8,161,000
|
8,177,000
|
|||||
Commitments
and Contingencies
|
|||||||
Shareholders’ equity: | |||||||
Preferred
stock, $0.01 par value, 6,000,000 shares authorized:
|
|||||||
Series
A preferred stock, 800,000 shares designated, none issued and
outstanding
|
—
|
—
|
|||||
Common
stock, $0.01 par value, 180,000,000 shares authorized, 98,501,855
shares
issued and outstanding at March 31, 2006 and 85,694,244 shares issued
and
outstanding at December 31, 2005
|
985,000
|
857,000
|
|||||
Additional
paid-in capital
|
284,668,000
|
279,772,000
|
|||||
Accumulated
deficit
|
(253,769,000
|
)
|
(250,037,000
|
)
|
|||
Accumulated
other comprehensive income (loss)
|
24,000
|
(21,000
|
)
|
||||
Total
shareholders’ equity
|
31,908,000
|
30,571,000
|
|||||
Total
liabilities and shareholders’ equity
|
$
|
51,083,000
|
$
|
48,798,000
|
See
accompanying notes to condensed consolidated
financial statements
1
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three
months ended
March
31,
|
|||||||
2006
|
2005
|
||||||
Revenue
under collaborative agreements
|
$
|
2,430,000
|
$
|
2,000,000
|
|||
Operating
expenses:
|
|||||||
Research
and development
|
3,677,000
|
4,539,000
|
|||||
General
and administrative
|
1,481,000
|
1,885,000
|
|||||
Restructure
charges
|
1,042,000
|
219,000
|
|||||
Total
operating expenses
|
6,200,000
|
6,643,000
|
|||||
Loss
from operations
|
(3,770,000
|
)
|
(4,643,000
|
)
|
|||
Investment
income
|
151,000
|
100,000
|
|||||
Interest
expense
|
(113,000
|
)
|
(129,000
|
)
|
|||
Net
loss
|
$
|
(3,732,000
|
)
|
$
|
(4,672,000
|
)
|
|
Net
loss per common share (basic and diluted)
|
$
|
(0.04
|
)
|
$
|
(0.05
|
)
|
|
Shares
used in computation of basic and diluted net loss per common
share
|
88,692,000
|
85,628,000
|
See
accompanying notes to condensed consolidated financial
statements
2
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Three
months ended
|
|||||||
March
31,
|
|||||||
|
2006
|
2005
|
|||||
Operating
activities:
|
|||||||
Net
loss
|
$
|
(3,732,000
|
)
|
$
|
(4,672,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
168,000
|
324,000
|
|||||
Stock-based
compensation
|
221,000
|
—
|
|||||
Loss
(gain) on investments
|
(5,000
|
)
|
63,000
|
||||
Non-cash
interest expense
|
—
|
115,000
|
|||||
Changes
in assets and liabilities:
|
|||||||
Decrease
(increase) in accounts receivable
|
(611,000
|
)
|
300,000
|
||||
Decrease
in prepaid expenses and other
|
78,000
|
315,000
|
|||||
Decrease
in other assets
|
2,000
|
60,000
|
|||||
Increase
in current liabilities
|
49,000
|
146,000
|
|||||
Increase
in deferred revenue
|
472,000
|
—
|
|||||
Increase
in accrued restructure expenses and deferred rent
|
482,000
|
55,000
|
|||||
Net
cash used in operating activities
|
(2,876,000
|
)
|
(3,294,000
|
)
|
|||
Investing
activities:
|
|||||||
Purchases
of property and equipment
|
(32,000
|
)
|
(180,000
|
)
|
|||
Proceeds
from sale of investments
|
36,000
|
—
|
|||||
Net
cash provided by (used in) investing activities
|
4,000
|
(180,000
|
)
|
||||
Financing
activities:
|
|||||||
Net
proceeds from sales of common stock
|
4,803,000
|
6,000
|
|||||
Payments
under leasehold improvements and equipment financing
arrangements
|
(55,000
|
)
|
(205,000
|
)
|
|||
Net
cash provided by (used in) financing activities
|
4,748,000
|
(199,000
|
)
|
||||
Net
increase (decrease) in cash and cash equivalents
|
1,876,000
|
(3,673,000
|
)
|
||||
Cash
and cash equivalents, beginning of period
|
14,122,000
|
34,096,000
|
|||||
Cash
and cash equivalents, end of period
|
$
|
15,998,000
|
$
|
30,423,000
|
|||
See
accompanying notes to condensed consolidated financial
statements
3
TARGETED
GENETICS CORPORATION
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Summary
of Significant Accounting Policies
Basis
of Presentation
The
unaudited condensed consolidated financial statements included in this quarterly
report have been prepared by Targeted Genetics Corporation, or Targeted
Genetics, according to the rules and regulations of the Securities and Exchange
Commission, or SEC, and according to accounting principles generally accepted
in
the United States of America, or GAAP, for interim financial statements. The
accompanying balance sheet information as of December 31, 2005 is derived from
our audited financial statements. Certain information and footnote disclosures
normally included in financial statements prepared in accordance with GAAP
have
been omitted in accordance with the SEC’s rules and regulations. Our condensed
consolidated financial statements include the accounts of Targeted Genetics
and
our inactive, wholly-owned subsidiaries, Genovo, Inc. and TGCF Manufacturing
Corporation.
All
significant intercompany transactions have been eliminated in consolidation.
The
financial statements reflect, in the opinion of management, all adjustments
which consist solely of normal recurring adjustments necessary to present fairly
our financial position and results of operations as of and for the periods
indicated. Certain reclassifications have been made to conform prior period
results to the current period presentation.
We
do not
believe that our results of operations for the three months ended March 31,
2006
are necessarily indicative of the results to be expected for the full
year.
The
unaudited condensed consolidated financial statements included in this quarterly
report should be read in conjunction with our audited consolidated financial
statements and related footnotes included in our annual report on Form 10-K
for
the year ended December 31, 2005.
Our
combined cash and cash equivalents total $16.0 million at March 31, 2006. We
expect that these funds plus the funding we expect from our partners will be
sufficient to fund our operations into the first quarter of 2007. This estimate
is based on our ability to perform planned research and development activities
and the receipt of planned funding from our collaborators. Our near-term
financing strategy includes leveraging our development capabilities and
intellectual property assets into additional capital raising opportunities,
advancing our clinical development programs and accessing the public and private
capital markets at appropriate times. Additional funding may not be available
to
us on reasonable terms, if at all. Depending on our ability to successfully
access additional funding, we may be forced to take cost reduction measures
that
may include scaling back, delaying or terminating one or more research and
development programs, curtailing capital expenditures or reducing other
operating activities. We have prepared the accompanying financial statements
assuming that we will continue as a going concern and our financial statements
do not reflect adjustments that may impact the amount and classifications of
assets or liabilities that may result from these liquidity
uncertainties.
Stock-Based
Compensation
Recently
Issued Accounting Standards
In
May
2005, the FASB issued SFAS No. 154 “Accounting
Changes and Error Corrections.” SFAS
No.
154 changes the requirements for accounting and reporting a change in accounting
principle. We are required to adopt SFAS No. 154 for accounting changes and
error corrections that occur after January 1, 2006. Under SFAS No. 154, our
results of operations and financial condition will be impacted only if we
implement changes in accounting principles that are addressed by the standards
or if we correct accounting errors in future periods.
4
2. Long-Term
Obligations
Long-term
obligations consisted of the following:
|
March
31,
|
December
31,
|
|||||
2006
|
2005
|
||||||
Loans
payable to Biogen Idec
|
$
|
8,150,000
|
$
|
8,150,000
|
|||
Equipment
financing obligations
|
127,000
|
182,000
|
|||||
Total
obligations
|
8,277,000
|
8,332,000
|
|||||
Less
current portion
|
(116,000
|
)
|
(155,000
|
)
|
|||
Total
long-term obligations
|
$
|
8,161,000
|
$
|
8,177,000
|
We
have
two loans payable to Biogen Idec, a beneficial owner of approximately 11.9%
of
our outstanding common shares. As of March 31, 2006 we have $7.5 million of
principle remaining on a $10.0 million note payable. Outstanding borrowings
under this unsecured loan agreement bear interest at the one-year London
Interbank Offered Rate, or LIBOR, plus 1%, which is reset quarterly. The loan
contains financial covenants establishing limits on our ability to declare
or
pay cash dividends and scheduled payments of $2.5 million of principal amount
plus accrued interest are due on each of August 1, 2007, 2008 and 2009. In
addition, we have agreed to apply one-third of certain up-front payments
received from potential future corporate collaborations to the outstanding
balance on this loan payable, first to repayment of any accrued and unpaid
interest on the principal being repaid, and second to the repayment of
outstanding principal in reverse order of maturity. The second loan is a
promissory note payable to Biogen Idec which we assumed in 2000 as part of
our
acquisition of Genovo. This promissory note has an outstanding principal amount
of $650,000, bears no interest and matures in August 2007.
Future
aggregate principal payments related to long-term obligations are $100,000
for
the remainder of 2006, $3,176,000 in 2007, $2,501,000 in 2008, $2,500,000 in
2009 and zero in 2010.
3. Accrued
Restructure Charges
We
apply
the provisions of SFAS No. 146, “Accounting
for Costs Associated with Exit or Disposal Activities,” as
it
relates to our facility in Bothell, Washington and record restructure charges
on
the operating lease for the facility as a result of our 2003 decision to
discontinue use of the facility. Accrued restructure charges represent our
best
estimate of the fair value of the liability as determined under SFAS No. 146
and
are computed as the fair value of the difference between the remaining lease
payments, net of assumed sublease income and expense. We also record accretion
expense based upon changes in the accrued liability that results from the
passage of time at an assumed discount rate of 10%. Accretion expense is
recorded on an ongoing basis through the end of the lease term in September
2015
and is reflected as a restructuring charge in the accompanying consolidated
statements of operations.
The
table
below presents a reconciliation of the accrued restructure liability for the
three month period ended March 31, 2006:
Contract
Termination Costs
|
Employee
Termination Benefits
|
Total
|
||||||||
December
31, 2005 accrued liability
|
$
|
7,149,000
|
$
|
—
|
$
|
7,149,000
|
||||
Charges
incurred
|
639,000
|
219,000
|
858,000
|
|||||||
Adjustments
to the liability (accretion)
|
184,000
|
—
|
184,000
|
|||||||
Amount
paid
|
(346,000
|
)
|
(219,000
|
)
|
(565,000
|
)
|
||||
March
31, 2006 accrued liability
|
$
|
7,626,000
|
$
|
—
|
$
|
7,626,000
|
.
For
the
three months ended March 31, 2006, we have recorded additional restructure
charges of $639,000 as a result of updating our estimates of costs and sublease
income associated with exiting the Bothell facility. Market conditions for
subleasing the facility continued to be poor, therefore, we extended our
estimate for additional time that may be required to find a sublease tenant.
In
addition, we reviewed and adjusted downward our assumptions surrounding
escalation in sublease rental income. Adjustments to the accrued restructure
liability for the three months ended March 31, 2006 reflect $184,000 of
accretion expense for the period. The total of these charges and adjustments
to
the liability are reflected as restructure charges in the accompanying Condensed
Consolidated Statement of Operations.
5
Restructuring
charges also includes $219,000 of restructuring expenses related to the
restructuring announced in January 2006 in order to reduce expenses and realign
resources to advance our inflammatory arthritis product through clinical trials.
We reduced our workforce by 26 employees, primarily in early-stage research
and
development groups and in operational and general and administrative functions.
We do not anticipate any additional charges related to this
restructuring.
Through
March 31, 2006, we have recorded contract termination costs totaling $9.2
million for our Bothell facility. We expect to incur an additional $3.4 million
in accretion expense through the expiration of the Bothell lease in September
2015.
We
periodically evaluate our restructuring estimates and assumptions and record
additional restructure charges as necessary. Because restructure charges are
estimates based upon assumptions regarding the timing and amounts of future
events, significant adjustments to the accrual may be necessary in the future
based on the actual outcome of events and as we become aware of new facts and
circumstances.
4.
Equity
Financing
On
March
10, 2006, we sold 12,791,611 shares of our common stock in a public offering
at
a price of $0.39 per share and received net proceeds of approximately $4.8
million.
Stock
Compensation
We
have
various stock option plans (Option Plans) that provide for the issuance of
nonqualified and incentive stock options to acquire up to 12,979,444 shares
of
our common stock. These stock options may be granted by our Board of Directors
to our employees, directors and officers and to consultants, agents, advisors
and independent contractors who provide services to us. The exercise price
for
incentive stock options shall not be less than the fair market value of the
shares on the date of grant. Options granted under our Option Plans expire
no
later than ten years from the date of grant and generally vest and become
exercisable over a four-year period following the date of grant. In addition,
every non-employee member of our Board of Directors receives an annual
nonqualified stock option grant and these options vest over a 12 month period
provided they continue service to us. Stock option exercises are fulfilled
through the issuance of new shares of common stock.
Effective
January 1, 2006, we adopted SFAS No. 123R “Share-Based
Payment.”
SFAS No.
123R requires us to expense the fair value of stock options granted over the
vesting period. We have adopted SFAS No. 123R using the modified prospective
application method and recognized $221,000 of stock-based compensation expense
in the first quarter of 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, 2006, we classified $125,000 as research and development expense
and $96,000 as general and administrative expense. As
of
March 31, 2006, total unrecognized compensation cost related to unvested options
was approximately $800,000, net of estimated forfeitures, which we expect to
recognize over a weighted average period of approximately 11 months.
6
Prior
to
January 1, 2006, we had adopted the pro forma disclosure feature of SFAS No.
123, “Accounting
for Stock-Based Compensation,”
accounted for stock options under Accounting Principles Board No. 25,
“Accounting
for Stock Issued to Employees,”
which
uses the intrinsic value method and generally recognizes no compensation cost
for employee stock option grants. The following table illustrates the effect
on
net loss and loss per share amounts if we had applied the fair value recognition
provisions of SFAS No. 123 to stock-based employee compensation for the three
months ended March 31, 2005:
Three
months
ended
|
||||
March
31, 2005
|
||||
Net
loss:
|
||||
As
reported
|
$
|
(4,672,000
|
)
|
|
Pro
forma stock-based compensation expense
|
(464,000
|
)
|
||
Pro
forma
|
$
|
(5,136,000
|
)
|
|
Basic
and diluted net loss per share:
|
||||
As
reported
|
$
|
(0.05
|
)
|
|
Pro
forma
|
(0.06
|
)
|
Following
is a summary of stock option activity and related prices for the first quarter
of 2006:
|
Shares
|
Weighted
Average
Exercise
Price
|
|||||
Balance,
December 31, 2005
|
7,040,870
|
2.09
|
|||||
Granted
|
12,000
|
0.46
|
|||||
Exercised
|
(16,000
|
)
|
0.40
|
||||
Expired
|
—
|
—
|
|||||
Forfeited
|
(705,174
|
)
|
1.74
|
||||
Balance,
March 31, 2006
|
6,331,696
|
2.13
|
Stock
options outstanding and exercisable as of March 31, 2006 are summarized
below:
Outstanding
|
|
Exercisable
|
|||||||||||||||
Range of Exercise Prices |
Number
of
Option
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Life
(Years)
|
Number
of
Option
Shares
|
Weighted
Average
Exercise
Price
|
||||||||||||
$
|
0.29
-$0.49
|
568,117
|
$
|
0.38
|
7.05
|
522,992
|
$
|
0.37
|
|||||||||
0.60
- 0.84
|
609,804
|
0.75
|
7.64
|
335,569
|
0.78
|
||||||||||||
0.91
- 1.28
|
1,119,554
|
0.95
|
8.46
|
313,122
|
1.05
|
||||||||||||
1.31
- 1.31
|
1,797,262
|
1.31
|
8.14
|
887,407
|
1.31
|
||||||||||||
1.32
- 2.53
|
845,890
|
1.89
|
3.62
|
789,668
|
1.91
|
||||||||||||
2.57
- 14.88
|
1,391,069
|
5.58
|
4.73
|
1,362,694
|
5.64
|
||||||||||||
Balance,
March 31, 2006
|
6,331,696
|
2.13
|
6.69
|
4,211,452
|
2.65
|
The
total
intrinsic value of stock options is summarized as follows:
|
Number
of
Option
Shares
|
Aggregate
Intrinsic
Value
|
|||||
Options
outstanding at March 31, 2006
|
6,331,696
|
$
|
32,000
|
||||
Options
exercisable at March 31, 2006
|
4,211,452
|
$
|
32,000
|
||||
Options
exercised during the three months ended March 31, 2006
|
16,000
|
$
|
1,000
|
7
The
aggregate intrinsic value is determined using the closing price of our common
stock on March 31, 2006 of $0.43 per share. The fair value of each stock option
award is estimated on the date of the grant using the Black-Scholes-Merton
option pricing model. The following are the weighted average assumptions for
the
periods noted:
Three
Months ended March 31,
|
|||||||
2006
|
2005
|
||||||
Expected
dividend rate
|
Nil
|
Nil
|
|||||
Expected
stock price volatility
|
1.086
|
1.122
|
|||||
Risk-free
interest rate range
|
4.25%
|
3.25-3.79%
|
|||||
Expected
life of options
|
5 years | 4 years |
The
risk-free interest rate is based on the U.S. treasury security rate. The
expected life of options and the expected volatility ranges are estimated based
on our historical data.
The
weighted average fair value of stock options granted during the first quarter
2006 was $0.37 and was $0.95 for the first quarter of 2005.
Comprehensive
loss is the total of net loss and all other non-owner changes in equity.
Comprehensive loss includes unrealized gains and losses from investments and
foreign currency translations, as presented in the following table:
Three
months ended
March
31,
|
|||||||
|
2006
|
2005
|
|||||
Net
loss as reported
|
$
|
(3,732,000
|
)
|
$
|
(4,672,000
|
)
|
|
Other
comprehensive loss:
|
|||||||
Unrealized
gain on available-for-sale securities
|
8,000
|
—
|
|||||
Foreign
currency translation adjustment
|
16,000
|
—
|
|||||
Other
comprehensive loss
|
$
|
(3,708,000
|
)
|
$
|
(4,672,000
|
)
|
6.
Subsequent Event
During
April 2006, we signed a lease amendment with our landlord for a portion of
our
facilities in Seattle, Washington. This lease amendment reduces our leased
space
and extends the lease term on the remaining premises. This lease amendment
is
the continuation of our restructuring efforts that began in January 2006 in
order to focus our cash resources on funding our inflammatory arthritis clinical
trial. Upon the signing of the lease amendment, we paid a total of $117,000
in
lease termination fees, and we will pay an additional four consecutive monthly
installments of $15,000 starting in May 2006. These expenses will be recorded
as
a restructuring charge in the second quarter of 2006.
8
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
Forward-Looking
Statements
This
quarterly report on Form 10-Q contains forward-looking statements that involve
risks and uncertainties. Forward-looking statements include statements about
our
product development and commercialization goals and expectations, potential
market opportunities, our plans for and anticipated results of our clinical
development activities and the potential advantage of our product candidates,
our future cash requirements and the sufficiency of our cash and cash
equivalents to meet these requirements, our ability to raise capital when needed
and other statements that are not historical facts. Words such as “may,” “will,”
“believes,” “estimates,” “expects,” “anticipates,” “plans” and “intends,” or
statements concerning “potential” or “opportunity” and other words of similar
meaning or the negative thereof, may identify forward-looking statements, but
the absence of these words does not mean that the statement is not
forward-looking. In making these statements, we rely on a number of assumptions
and make predictions about the future. Our actual results could differ
materially from those stated in, or implied by, forward-looking statements
for a
number of reasons, including the risks described in the section entitled “Risk
Factors” in Part II, Item 1A of this quarterly report.
You
should not unduly rely on these forward-looking statements, which speak only
as
of the date of this quarterly report. We undertake no obligation to publicly
revise any forward-looking statement after the date of this quarterly report
to
reflect circumstances or events occurring after the date of this quarterly
report or to conform the statement to actual results or changes in our
expectations. You should, however, review the factors, risks and other
information we provide in the reports we file from time to time with the
Securities and Exchange Commission, or SEC.
BUSINESS
OVERVIEW
Targeted
Genetics Corporation is a clinical-stage biotechnology company, we are at the
forefront of developing a new class of gene-based products. We believe that
a
wide range of diseases may be treated or prevented with gene-based products.
In
addition to treating diseases which have not had treatments in the past, we
believe that there is also a significant opportunity to use gene-based products
to more effectively treat diseases that are currently treated using other
therapeutic classes of drugs including proteins, monoclonal antibodies, or
small
molecule drugs. We have multiple product candidates, two of which are currently
in clinical trials. Our clinical-stage candidates are aimed at inflammatory
arthritis and HIV/AIDS. Our preclinical product candidates are in development
with a variety of collaboration partners and are aimed at congestive heart
failure, HIV/AIDS and Huntington’s disease.
Our
product candidates consist of a delivery vehicle, called a vector, and genetic
material. The role of the vector is to carry the genetic material into a target
cell. Once delivered into the cell, the gene can express or direct production
of
the specific proteins encoded by the gene. Gene delivery may be used to treat
disease by replacing the missing or defective gene to facilitate the normal
protein production or gene regulation capabilities of cells. In addition, gene
delivery may be used to enable cells to perform additional roles in the body.
Gene delivery may also be used to shut down cellular functions.
We
are a
leader in the preclinical and clinical development of adeno-associated viral
vector, or AAV-based gene products and in the manufacture of AAV-vectors.
Through our research and development activities, we have developed expertise
and
intellectual property related to gene delivery technologies. We have developed
and applied processes to manufacture our potential products at a scale amenable
to late-stage clinical development and expandable to large-scale commercial
production. We have established broad capabilities in applying our AAV-based
gene delivery technologies to several indications, and we have developed an
infrastructure that allows us to expand these capabilities into multiple product
opportunities. We have treated over 250 subjects using AAV-based products with
no major safety concerns.
We
are
focused on the following product development programs:
Description
|
Indication
|
Partner
|
Development
Status
|
AAV
delivery of TNF-alpha antagonist (tgAAC94)
|
Inflammatory
Arthritis
|
Phase
I/II
|
|
AAV
delivery of HIV antigens (tgAAC09)
|
HIV/AIDS
|
IAVI
|
Phase
II
|
AAV
delivery of HIV antigens
|
HIV/AIDS
|
NIH
|
Preclinical
|
AAV
delivery of SERCA2a
|
Congestive
Heart Failure
|
Celladon
|
Preclinical
|
AAV
expression of htt siRNA
|
Huntington’s
disease
|
Sirna
|
Preclinical
|
9
We
have
financed our operations primarily through proceeds from public and private
sales
of our equity securities, through cash payments received from our collaborative
partners for product development and manufacturing activities, through proceeds
from the issuance of debt and loan funding under equipment financing
arrangements. On March 10, 2006, we sold 12,791,611 shares of our common stock
in a registered direct offering to institutional investors at a price of $0.39
per share, from which we received net proceeds of approximately $4.8
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 and accordingly, to an extent,
we
are able to reduce expenses and conserve our resources by reducing these
activities. For example, in January 2006 we restructured our operations to
concentrate our resources on generating data from the clinical trials of our
inflammatory arthritis product candidate, maintaining our manufacturing
capabilities and advancing our funded product development efforts. As part
of
this restructuring we eliminated 26 positions, which reduced our workforce
by
approximately 27%, including scientific, operations and administrative functions
that were not required to support our programs. This restructuring primarily
affected earlier-stage product discovery and preclinical product development
efforts, small-scale vector manufacturing employees, management positions and
operations and general and administrative support.
As
of
March 31, 2006, our accumulated deficit totaled $253.8 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.
Notwithstanding
our January 2006 cost-cutting measures, 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.
Over
the
longer term, our business strategy is to leverage our technology assets,
manufacturing capabilities and gene therapy product development expertise into
multiple development programs and collaborations to maximize our opportunities
to commercialize a product candidate. We believe that, if successful, our
product candidates will have significant market potential. We intend to pursue
product development programs that enable us to demonstrate the potential of
our
technology and eventually to commercialize gene-based therapeutics that address
currently unmet medical needs.
The
development of pharmaceutical products, including our potential inflammatory
arthritis, prophylactic HIV/AIDS vaccine, congestive heart failure, and
Huntington’s disease product candidates discussed above, involves extensive
preclinical development followed by human clinical trials that take several
years or more to complete. The length of time required to completely develop
any
product candidate varies substantially according to the type, complexity and
novelty of the product candidate, the degree of involvement by a development
partner and the intended use of the product candidate. Our commencement and
rate
of completion of clinical trials may vary or be delayed for many reasons,
including those discussed in the section entitled “Risk Factors” presented
below.
CRITICAL
ACCOUNTING POLICIES, ESTIMATES AND ASSUMPTIONS
Stock-Based
Compensation
Prior
to
January 1, 2006, we had applied the intrinsic value method of accounting for
stock options granted to our employees and directors under the provisions of
Accounting Principles Board Opinion No. 25, “Accounting
for Stock Issued to Employees”,
and
related interpretations, as permitted by SFAS No. 123 “Accounting
for Stock-Based Compensation.”
Accordingly, we did not recognize any compensation expense for options granted
to employees or directors because we grant all options at fair market value
on
the date of grant.
On
January 1, 2006, we adopted SFAS No. 123R “Share-Based
Payment.”
We have
adopted the SFAS No. 123R fair value recognition provisions using the modified
prospective transition method. Under the modified prospective method,
compensation expense includes:
(a)
compensation cost for all share-based stock options granted prior to, but not
yet vested as of January 1, 2006, based on the grant-date fair value used for
prior pro forma disclosures and (b) compensation cost for all share-based
payments granted subsequent to January 1, 2006, based on the grant-date fair
value estimate in accordance with the provisions of SFAS No. 123R. Results
for periods prior to January 1, 2006 have not been restated. As a result of
adopting SFAS No. 123R, we recorded $221,000 of expense for stock-based
compensation, of which $125,000 was classified as research and development
and
$96,000 was classified as general and administrative expense. The proforma
cost
of stock options compensation for the three months ended March 31, 2005 was
$464,000, for which no expense was recorded as allowed under the provisions
of
APB Opinion No. 25. As of March 31, 2006, total unrecognized compensation cost
related to unvested options was approximately $800,000, net of estimated
forfeitures, which we expect to recognize over a weighted average period of
approximately 11 months.
10
Determining
the appropriate fair value model and calculating the fair value of share-based
payment awards require the input of highly subjective assumptions, including
the
expected life of the share-based payment awards and stock price volatility.
We
based our volatility and expected life estimates based on our historical data.
The assumptions used in calculating the fair value of share-based payment awards
represent our best estimates, but these estimates involve inherent uncertainties
and the application of judgment. As a result, if factors change and we use
different assumptions, our stock-based compensation expense could be materially
different in the future. In addition, we are required to estimate the expected
forfeiture rate and only recognize expense for those shares expected to vest.
If
our actual forfeiture rate is materially different from our estimate, the
stock-based compensation expense could be significantly different from what
we
have recorded in the current period. See Note 4 to the condensed consolidated
financial statements for a further discussion on stock-based
compensation.
RESULTS
OF OPERATIONS
Revenue
Revenue
increased to $2.4 million for the three months ended March 31, 2006 compared
to
$2.0 million for the same period in 2005. The increase in revenue reflects
higher research and development activities under our collaboration with Celladon
and our recently initiated research and development activities under the NIH
grant, partially offset by decreased research and development activities from
our collaboration with IAVI. We expect that our revenue for the remainder of
2006 will consist primarily of research and development revenue earned under
our
collaborations with IAVI and Celladon and the contract from the NIH. For the
next several years, our revenue will depend on the continuation of the current
collaborations and our success with entering into and then performing under
new
collaborations.
Operating
Expenses
Research
and Development Expenses. Research
and development expenses decreased to $3.7 million for the three months ended
March 31, 2006 compared to $4.5 million for the same period in 2005. This
decrease reflects cost reductions from our restructuring efforts implemented
in
January 2006 and lower costs related to our HIV/AIDS vaccine collaboration
with
IAVI as a result of lower development costs. This decrease was partially offset
by higher research and preclinical development program expenses in support
of
our congestive heart failure collaboration with Celladon and to a lesser extent,
costs connected with the initiation of work with CRI and Children’s Hospital of
Philadelphia as part of the NIAID HIV/AIDS vaccine project. We expect that
our
research and development expenses for the remainder of 2006 will vary depending
on the timing of outside services necessary to support our clinical programs,
our collaboration with Celladon and collaboration with CRI and Children’s
Hospital of Philadelphia in support of the NIAID HIV/AIDS vaccine project.
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,
|
|||||||
|
2006
|
2005
|
|||||
Programs
in clinical development:
|
|||||||
Inflammatory
arthritis
|
$
|
558,000
|
$
|
586,000
|
|||
HIV/AIDS
vaccine
|
317,000
|
1,124,000
|
|||||
Cystic
fibrosis
|
18,000
|
189,000
|
|||||
Indirect
costs
|
329,000
|
1,511,000
|
|||||
Total
clinical development program expense
|
1,222,000
|
3,410,000
|
|||||
Research
and preclinical development program expense
|
2,455,000
|
1,129,000
|
|||||
Total
research and development expense
|
$
|
3,677,000
|
$
|
4,539,000
|
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 AIDS vaccine program. As a result, we do not include
those costs in our research and development expenses.
11
Costs
attributed to research and preclinical programs represent our earlier-stage
development activities and include costs incurred for the HIV/AIDS vaccine
development activities under the NIH grant and the congestive heart failure
programs as well as other programs prior to their transition into clinical
trials. Research and preclinical program expense also includes costs that are
not allocable to a clinical development program, such as unallocated
manufacturing infrastructure costs. Because we conduct multiple research
projects and utilize resources across several programs, our research and
preclinical development costs are not directly assigned to individual programs.
For
purposes of reimbursement from our collaboration partners, we capture the level
of effort expended on a program through our project management system, which
is
based primarily on human resource time allocated to each program, supplemented
by an allocation of indirect costs and other specifically identifiable costs,
if
any. As a result, the costs allocated to programs identified in the table above
do not necessarily reflect the actual costs of the program.
General
and Administrative Expenses. General
and administrative expenses decreased to $1.5 million for the three months
ended
March 31, 2006 from $1.9 million for the same period in 2005. The decrease
reflects the lower patent and payroll expenses as a result of the January 2006
restructuring, offset partially by stock-based compensation expense for general
and administrative employees.
Restructure
Charges. Restructure
charges increased to $1,042,000 for the three months ended March 31, 2006,
compared to $219,000 for the same period in 2005. Restructuring charges in
both
periods include charges of $639,000 in 2006 and $100,000 in 2005 related to
changes in our expectations regarding market conditions for the Bothell facility
subleasing market. Restructuring charges also include accretion expense of
$184,000 in the period ended March 31, 2006 and $119,000 in the period ended
March 31, 2005. In January 2006, we recorded a $219,000 charge related to the
employee termination benefits of our restructuring efforts to realign our
resources to advance our lead inflammatory arthritis product through clinical
trials.
Other
Income and Expense
Investment
Income. Investment
income increased to $151,000 for the three month period ended March 31, 2006
compared to $100,000 for the same period in 2005. Interest income reflects
interest income earned on our short term investments and for the three month
period ended March 31, 2005 also reflects a $63,000 charge related to the
write-off of a debenture that we received from Chromos Molecular Systems as
part
of merger consideration for the July 2004 sale of CellEySys, our majority-owned
subsidiary.
Interest
Expense. Interest
expense relates to interest on outstanding loans from our collaborative
partners, notes and obligations under equipment financing arrangements that
we
use to finance purchases of laboratory and computer equipment, furniture and
leasehold improvements. Interest expense decreased to $113,000 for the three
months ended March 31, 2006, compared to $129,000 for the same period in 2005.
The decrease primarily reflects lower interest charges on decreased principal
amounts outstanding under our equipment financing arrangements.
Liquidity
and Capital Resources
We
had
cash and cash equivalents balances of $16.0 million as of March 31, 2006
compared to $14.1 million as of December 31, 2005. Our cash and cash equivalents
increased in the first quarter of 2006 reflecting net proceeds of $4.8 million
from our March 10, 2006 sale of 12.8 million shares of our common stock offset
by our net loss of $3.7 million for the quarter and the resulting cash used
in
operations of $2.9 million. Our shareholders’ equity increased to
$31.9 million
at March 31, 2006, compared to $30.6 million at December 31, 2005 also
reflecting our March sale of common stock offset by our year-to-date cash used
in operations.
On
March
10, 2006, we sold 12,791,611 shares of our common stock in a public offering
at
a price of $0.39 per share and received net proceeds of approximately $4.8
million. We intend to continue to seek appropriate opportunities to access
the
public and private capital markets, however, our ability to issue equity
securities at the current market price will likely be adversely affected by
the
fact that we are presently ineligible under SEC rules to utilize Form S-3 for
primary offerings of our securities because the aggregate market value of our
outstanding common stock held by non-affiliates is less than $75
million.
Our
primary expenses are related to the development of our research and development
programs, the conduct of preclinical studies and clinical trials and general
and
administrative support for these activities. Our HIV/AIDS vaccine candidate
and
our inflammatory arthritis product candidate are both in clinical trials. We
expect to continue incurring significant expense in advancing our 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.
12
Since
implementing a reduction in force in January 2006, we have focused our
development funding on our inflammatory arthritis product candidate which is
in
clinical trials. During 2005, we spent approximately $2.4 million on this
program in outside costs and allocated staff costs to support research and
development activities and clinical trial costs, and we expect to spend
approximately $3 million to $4 million in 2006 on this program, largely for
clinical trial expenses. We currently fund all costs of this program from our
working capital and expect to do so for the foreseeable future, although our
strategy is to ultimately seek a partner to fund later-stage development of
this
program.
In
addition to the funding necessary to advance our product development and fund
our ongoing operating costs, we also have significant outstanding debt, lease
commitments and long-term obligations which draw on our cash resources. Our
most
significant obligations are approximately $14.3 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 long-term debt to Biogen Idec of $8.2
million. Under our modified loan agreements with Biogen Idec, we are obligated
to make scheduled payments of $3.2 million of principal plus accrued interest
on
August 1, 2007 and $2.5 million of principal plus accrued interest on August
1,
2008 and August 1, 2009. In addition, we have agreed to apply one-third of
certain up-front payments received from potential future corporate
collaborations to the outstanding balance on this loan payable, first to
repayment of any accrued and unpaid interest on the principal being repaid,
and
second to the repayment of outstanding principal in reverse order of maturity.
We will need to raise additional capital to make the scheduled payments and
to
repay these notes.
We
expect
the level of our future operating expenses to be driven by the needs of our
product development programs, our debt obligations and our lease obligations
offset by the availability of funds through equity offerings, partner-funded
collaborations or other financing or business development activities. The size,
scope and pace of our product development activities depend on the availability
of these resources. Our future cash requirements will depend on many factors,
including:
• |
the
rate and extent of scientific progress in our research and development
programs;
|
• |
the
timing, costs and scope of, and our success in, conducting clinical
trials, obtaining regulatory approvals and pursuing patent
prosecutions;
|
• |
competing
technological and market developments;
|
• |
the
timing and costs of, and our success in, any product commercialization
activities and facility expansions, if and as required;
and
|
• |
the
existence and outcome of any litigation or administrative proceedings
involving intellectual property.
|
We
have
financed our product development activities and general corporate functions
primarily through proceeds from public and private sales of our equity
securities, through cash payments received from our collaborative partners
and
proceeds from the issuance of debt. To a lesser degree, we have also financed
our operations through interest earned on cash and cash equivalents, loan
funding under equipment financing agreements and research grants. These
financing sources have historically allowed us to maintain adequate levels
of
cash and cash equivalents.
Our
development collaborations have typically provided us with funding in several
forms, including purchases of our equity securities, loans, payments for
reimbursement of research and development costs and milestone fees and payments.
We and our partners typically agree on a target disease and create a development
plan for the product candidate, which often extends for multiple years and
is
subject to termination or extension. For example, when the IAVI collaboration
was initiated in 2000, it originally had a three-year term and our most recent
extension to the IAVI collaboration extended the agreement through December
2006. In 2005 we extended the scope of our HIV/AIDS vaccine program via a
collaboration between Children’s Hospital of Philadelphia, Children’s Research
Institute and us under a contract awarded by the NIAID. Our portion of the
funding for this new collaboration could be up to $18 million over the next
five
years.
The
funding from each of our collaborative partners fully offsets our incremental
program costs from each collaboration and also partially funds development
of
our inflammatory arthritis product candidate, overhead and fixed costs. Our
revenue from collaborative agreements totaled $6.9 million in 2005 and $9.7
million in 2004 and assuming that we complete all of the planned development
activities for each of these funded projects, we expect to earn revenue of
up to
approximately $9 million in 2006.
13
Our
partners have the right to terminate our collaborations and their obligation
to
provide research funding at any time for any reason. For example IAVI can
terminate our HIV/AIDS vaccine collaboration with 90 days notice. If we were
to
lose the collaborative funding expected from our IAVI collaboration, our NIAID
collaboration with Children’s Hospital of Philadelphia and Children’s Research
Institute or our Celladon collaboration and were unable to obtain alternative
sources of funding for the product candidate under development in that
collaboration, we may be unable to continue our research and development program
for that product candidate.
Our
near-term financing strategy includes leveraging our development capabilities
and intellectual property assets into additional capital raising opportunities,
advancing our clinical development programs and accessing the public and private
capital markets at appropriate times. In addition, we intend to manage our
cash by focusing on advancing our inflammatory product candidate through
clinical testing. Our financing strategy is focused around the advancement
of
our two programs in clinical development, advancement of our newer development
collaborations and leveraging value out of our other intellectual assets and
capabilities. Our ability to raise capital depends in part on clinical trial
success. For example, in March 2005 we announced the initial results of a Phase
II clinical trial of tgAAVCF for the treatment of cystic fibrosis, and our
decision to discontinue the development of that product candidate based on
those
results. The termination of our cystic fibrosis program reduced the resources
available to fund our operations and affected our ability to raise additional
capital in 2005.
We
are
currently evaluating additional sources of financing which could involve one
or
more of the following:
• |
issuing
equity in the public or private markets;
|
• |
extending
or expanding our current
collaborations;
|
• |
entering
into additional product development
collaborations;
|
• |
selling
or licensing our technology or product candidates;
|
• |
borrowing
under loan or equipment financing arrangements; or
|
• |
issuing
debt.
|
We
expect
that our total cash requirements for 2006 will range from $13
million to $16 million and that our cash and cash equivalents at March 31,
2006,
plus the funding from our product development collaborations and contracts
will
be sufficient to fund our operations into the first quarter of 2007. This
estimate is based on our ability to perform planned research and development
activities and the receipt of planned funding from our
collaborators.
Additional
funding may not be available to us on reasonable terms, if at all. Our ability
to issue equity, and our ability to issue it at the current market price, may
be
adversely affected by the fact that we are presently ineligible under SEC rules
to utilize Form S-3 for primary offerings of our securities because the
aggregate market value of our outstanding common stock held by non-affiliates
is
less than $75 million. Depending on our ability to successfully access
additional funding, we may be forced to implement significant cost reduction
measures. These adjustments may include scaling back, delaying or terminating
one or more research and development programs, curtailing capital expenditures
or reducing other operating activities. We may also be required to relinquish
some rights to our technology or product candidates or grant licenses on
unfavorable terms, either of which would reduce the ultimate value to us of
the
technology or product candidates.
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
Items
with interest rate risk:
· |
Short
term investments:
Because of the short-term nature of our investments, we believe
that our
exposure to market rate fluctuations on our investments is minimal.
Currently, we do not use any derivative or other financial instruments
or
derivative commodity instruments to hedge any market risks and
do not plan
to employ these instruments in the future. At March 31, 2006, we
held
$16.0 million in cash and cash equivalents, which are primarily
invested
in money market funds and denominated in U.S. dollars. An analysis
of the
impact on these securities of a hypothetical 10% change in short-term
interest rates from those in effect at March 31, 2006, indicates
that such
a change in interest rates would not have a significant impact
on our
financial position or on our expected results of operations in
2006.
|
· |
Notes
payable:
Our results of operations are affected by changes in short-term
interest
rates as a result of a loan from Biogen which contains a variable
interest
rate. Interest payments on this loan are established quarterly
based upon
the one-year London Interbank Offered Rate, or LIBOR, plus 1%.
As of March
31, 2006, we were accruing interest on the note at a rate of 4.94%.
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,
2006,
about our obligations that are sensitive to changes in interest
rate
fluctuations:
|
Expected
Maturity Date
|
|||||||||||||||||||
|
2006
|
2007
|
2008
|
2009
|
2010
|
Total
|
|||||||||||||
Variable
rate note
|
$
|
—
|
$
|
2,500,000
|
$
|
2,500,000
|
$
|
2,500,000
|
$
|
—
|
$
|
7,500,000
|
Items
with market and foreign currency exchange risk:
· |
Investment
in Chromos Molecular Systems, Inc.:
At
March 31, 2006, we held 2.5 million shares of Chromos Molecular
Systems,
Chromos, common shares with a market value of $0.18 per common
share
denominated in Canadian dollars. As of March 31, 2006 the Canadian
to US
exchange rate was US $0. 8568 per CA $1.00. As of March 31, 2006,
the
investment is recorded at $391,000 with a $24,000 unrealized gain
and is
classified within prepaid expenses and other. We hold these shares
of
common stock as available-for-sale securities as we periodically
sell them
on the Toronto Stock Exchange. As a result of selling 205,000 shares
of
Chromos stock in 2006, we recorded $5,000 of net realized gains
and
received $36,000 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.
|
14
Evaluation
of disclosure controls and procedures. Based
on
our management’s evaluation, with the participation of our Chief Executive
Officer and Chief Financial Officer, of the effectiveness of our disclosure
controls and procedures as of the end of the period covered by this quarterly
report, our Chief Executive Officer and Chief Financial Officer have concluded
that our disclosure controls and procedures are effective in ensuring that
information we are required to disclose in reports that we file or submit
under
the Securities Exchange Act of 1934, as amended, is recorded, processed,
summarized and reported within the time periods specified in the Securities
and
Exchange Commission rules and forms.
Changes
in internal control over financial reporting. There
was
no change in our internal control over financial reporting, that occurred during
the period covered by this quarterly report that materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
None.
Item
1A. Risk Factors
Other
than with respect to the risk factors below, there have been no material changes
from the risk factors disclosed in “Section 1A. Risk Factors” of the Company’s
Annual Report on Form 10-K for the year ended December 31, 2005. The three
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,
2006.
If
we are unable to raise additional capital when needed, we will be unable to
conduct our operations and develop our potential
products.
Because
internally generated cash flow will not fund development and commercialization
of our product candidates, we will require substantial additional financial
resources. Our future capital requirements will depend on many factors,
including:
· |
the
rate and extent of scientific progress in our research and development
programs;
|
· |
the
timing, costs and scope of, and our success in, conducting clinical
trials, obtaining regulatory approvals and pursuing patent
prosecutions;
|
· |
competing
technological and market developments;
|
· |
the
timing and costs of, and our success in, any product commercialization
activities and facility expansions, if and as required;
and
|
· |
the
existence and outcome of any litigation or administrative proceedings
involving intellectual property.
|
We
expect
that our cash and cash equivalents at March 31, 2006, plus the funding from
our
partners will be sufficient to fund our operations into the first quarter
of
2007. This estimate is based on our ability to perform planned research and
development activities and the receipt of planned funding from our
collaborators. In addition, we owe approximately $8.2 million in aggregate
principal amount under two notes payable to Biogen Idec. The terms of the
notes
require us to make scheduled principal payments of $3.2 million in August
2007
and $2.5 million in each of August 2008 and 2009. We will need to raise
additional capital to make the scheduled payments and to repay these notes.
Additional sources of financing could involve one or more of the following:
· |
issuing
equity in the public or private markets;
|
· |
extending
or expanding our current
collaborations;
|
· |
entering
into additional product development
collaborations;
|
· |
selling
or licensing our technology or product candidates;
|
· |
borrowing
under loan or equipment financing arrangements; or
|
· |
issuing
debt.
|
15
Additional
funding may not be available to us on reasonable terms, if at all. Our ability
to issue equity, and our ability to issue it at the current market price, may
be
adversely affected by the fact that we are presently ineligible under SEC rules
to utilize Form S-3 for primary offerings of our securities because the
aggregate market value our outstanding common stock held by non-affiliates
is
less than $75 million.
The
perceived risk associated with the possible sale of a large number of shares
could cause some of our stockholders to sell their stock, thus causing the
price
of our stock to decline. In addition, actual or anticipated downward pressure
on
our stock price due to actual or anticipated sales of stock could cause some
institutions or individuals to engage in short sales of our common stock, which
may itself cause the price of our stock to decline.
If
our
stock price declines, we may be unable to raise additional capital. A sustained
inability to raise capital could force us to go out of business. Significant
declines in the price of our common stock could also impair our ability to
attract and retain qualified employees, reduce the liquidity of our common
stock
and result in the delisting of our common stock from the NASDAQ Capital
Market.
The funding that we expect to receive from our collaborations depends on
continued scientific progress under the collaboration and our collaborators’
ability and willingness to continue or extend the collaboration. If we are
unable to successfully access additional capital, we may need to scale back,
delay or terminate one or more of our development programs, curtail capital
expenditures or reduce other operating activities. We may also be required
to
relinquish some rights to our technology or product candidates or grant or
take
licenses on unfavorable terms, either of which would reduce the ultimate value
to us of our technology or product candidates.
We
expect to continue to operate at a loss and may never become
profitable.
Substantially all of our revenue has been derived under collaborative research
and development agreements relating to the development of our potential product
candidates. We have incurred, and will continue to incur for the foreseeable
future, significant expense to develop our research and development programs,
conduct preclinical studies and clinical trials, seek regulatory approval for
our product candidates and provide general and administrative support for these
activities. As a result, we have incurred significant net losses since
inception, and we expect to continue to incur substantial additional losses
in
the future. As of March 31, 2006, we had an accumulated deficit of
$253.8 million. We may never generate profits and, if we do become
profitable, we may be unable to sustain or increase profitability.
If
we are unable to comply with the minimum requirements for quotation on the
NASDAQ Capital Market and we may be delisted from the NASDAQ Capital Market,
the
liquidity and market price of our common stock would
decline.
Our
stock is listed on the NASDAQ Capital Market. In order to continue to be listed
on the NASDAQ Capital Market, we must meet specific quantitative standards,
including maintaining a minimum bid price of $1.00 for our common stock. On
May
31, 2005, we received a notice from the NASDAQ Stock Market informing us that
for 30 consecutive business days the bid price of our common stock had closed
below the minimum $1.00 per share requirement for continued inclusion under
Marketplace Rule 4310(c)(4). The letter stated that under Marketplace Rule
4310(c)(8)(d), we were provided with 180 calendar days, or until November 28,
2005, to regain compliance with Marketplace Rule 4310(c)(4). To regain
compliance, the bid price of our common stock must close at $1.00 per share
or
more for a minimum of 10 consecutive business days. As of November 28, 2005,
we
had not regained compliance with Market place Rule 4310(c). However, since
we
met all of the NASDAQ Stock Market’s criteria set forth in Marketplace Rule
4310(c), except for the bid price requirement, the NASDAQ provided us with
an
additional 180 calendar day compliance period, or until May 26, 2006, to
demonstrate full compliance and maintain our listing on the NASDAQ Capital
Market. To date, we have not achieved the required minimum bid price. At our
annual meeting of shareholders, our shareholders will consider a proposal to
approve the amendment and restatement the Restated Articles to (i) effect a
reverse stock split of our stock in a ratio of one-for-five, one-for-seven,
or
one-for-ten, the final ratio to be determined by the Board of Directors, if
and
at such specific ratio as determined by the Board of Directors at any time
before the 2007 annual meeting of shareholders, and (ii) establish,
depending on the ratio of the reverse stock split, the authorized shares of
Common Stock at 36,000,000, 25,714,286 or 18,000,000 shares, respectively,
and the authorized shares of Preferred Stock at 1,200,000, 857,143 or
600,000 shares, respectively, (of which 360,000, 257,143 or
180,000 shares, respectively, shall be designated Series A
Participating Cumulative Preferred Stock) after giving effect to the reverse
stock split. We are seeking to effect a reverse stock split to decrease the
number of outstanding shares of Common Stock and increase the per share market
price of our Common Stock, which we believe will assist in our efforts to
maintain compliance with the continued listing requirements of the Nasdaq
Capital Market. However, there is no assurance that the per share market price
of our Common Stock will increase following any reverse stock split. If we
have
not regained compliance by May 26, 2006, the NASDAQ Staff will provide written
notification that our securities will be delisted.
16
Upon
delisting from the NASDAQ Capital Market, trading, if any, in our shares may
continue to be conducted on the OTC Bulletin Board or in a non-NASDAQ
over-the-counter market, such as the “pink sheets.” Delisting of our shares
would result in limited release of the market price of those shares and limited
analyst coverage and could restrict investors’ interest in our securities. Also,
a delisting could have a material adverse effect on the trading market and
prices for our shares and our ability to issue additional securities or to
secure additional financing. In addition, if our shares were not listed and
the
trading price of our shares was less than $5 per share, our shares could be
subject to Rule 15g-9 under the Securities Exchange Act of 1934 which, among
other things, requires that broker/dealers satisfy special sales practice
requirements, including making individualized written suitability determinations
and receiving a purchaser’s written consent prior to any transaction. In such
case, our securities could also be deemed to be a “penny stock” under the
Securities Enforcement and Penny Stock Reform Act of 1990, which would require
additional disclosure in connection with trades in those shares, including
the
delivery of a disclosure schedule explaining the nature and risks of the penny
stock market. Such requirements could severely limit the liquidity of our
securities.
Certain
of our loan agreements contain financial covenants establishing limits on our
ability to declare or pay cash dividends.
None.
None.
None.
See
the
Index to Exhibits included in this quarterly report.
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 3, 2006 | By: | /s/ H. STEWART PARKER |
H. Stewart Parker, |
||
President,
Chief Executive Officer and Director
(Principal
Executive Officer)
|
Date: May 3, 2006 | By: | /s/ DAVID J. POSTON |
David J. Poston, |
||
Chief
Financial Officer
(Principal
Financial and Accounting
Officer)
|
18
INDEX
TO EXHIBITS
Incorporated
by Reference
|
|||||||||||
Exhibit No.
|
Exhibit
Description
|
Form
|
Date
|
Number
|
Filed
Herewith
|
||||||
3.1
|
|
Amended
and Restated Articles of Incorporation
|
|
8-K
|
05/26/2005
|
3.1
|
|||||
3.2
|
|
Amended
and Restated Bylaws
|
|
10-K
|
12/31/1996
|
3.2
|
|||||
10.1
|
Form
of Indemnification Agreement between Targeted Genetics and its officers
and directors
|
10-K
|
12/31/1999
|
10.1
|
|||||||
10.2
|
Form
of Senior Management Employment Agreement between the registrant
and its
executive officers
|
10-K
|
12/31/1996
|
10.2
|
|||||||
10.3
|
Agreement
Under an NIH Prime Award, dated February 8, 2006, between The Children’s
Hospital of Philadelphia and Targeted Genetics*
|
10-K
|
12/31/2005
|
10.36
|
|||||||
X
|
|||||||||||
10.4
|
Sixth
Lease Amendment, dated April 25, 2006, between Targeted Genetics
and
Walton Corporation
|
||||||||||
31.1
|
Certification
of Chief Executive Officer pursuant to Rules 13a-15(e) and 15d-15(e)
under
the Securities Exchange Act of 1934, as amended
|
X
|
|||||||||
31.2
|
Certification
of Chief Financial Officer pursuant to Rules 13a-15(e) and 15d-15(e)
under
the Securities Exchange Act of 1934, as amended
|
X
|
|||||||||
32.1
|
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
X
|
||||||
32.2
|
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
X
|
||||||
____________
*
|
Portions
of these exhibits have been omitted based on a grant of or application
for
confidential treatment from the SEC. The omitted portions of these
exhibits have been filed separately with the
SEC.
|
19