form10q.htm
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
Quarterly Report Pursuant to
Section 13 or 15(d) of the Securities Exchange Act of
1934
|
For
the Quarterly Period Ended September 30, 2009
OR
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 No. 0-23047
SIGA
Technologies, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
|
13-3864870
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification. No.)
|
|
|
420
Lexington Avenue, Suite 408
New
York, NY
|
10170
|
(Address
of principal executive offices)
|
(zip
code)
|
Registrant’s
telephone number, including area code: (212) 672-9100
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 such filing requirements for
the past 90 days. Yes x No ¨.
Indicate by check mark whether the registrant has
submitted electronically and posted on its corporate Web site, if any, every
Interactive Data File required to be submitted and posted pursuant to Rule 405
of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or
for such shorter period that the registrant was required to submit and post such
files). Yes ¨ No ¨.
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. (Check one):
|
Large
accelerated filer ¨
|
Accelerated
filer ý
|
|
Non-accelerated
filer ¨
|
Smaller
reporting company ¨.
|
(Do not
check if a smaller reporting company)
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨ Nox.
As
of October 30, 2009 the registrant had
38,319,541 shares of common stock outstanding.
Form
10-Q
Table of
Contents
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Page
No.
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PART I – FINANCIAL
INFORMATION
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2
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13
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18
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18
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PART II – OTHER INFORMATION
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|
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19
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19
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19
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19
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19
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19
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19
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PART
I – FINANCIAL INFORMATION
Item 1 – Financial Statements.
SIGA
TECHNOLOGIES, INC.
CONSOLIDATED
BALANCE SHEETS (UNAUDITED)
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
1,442,256 |
|
|
$ |
2,321,519 |
|
Accounts
receivable
|
|
|
2,727,451 |
|
|
|
1,959,608 |
|
Deferred
transaction costs
|
|
|
- |
|
|
|
581,358 |
|
Prepaid
expenses
|
|
|
1,503,812 |
|
|
|
1,392,607 |
|
Total
current assets
|
|
|
5,673,519 |
|
|
|
6,255,092 |
|
|
|
|
|
|
|
|
|
|
Property,
plant and equipment, net
|
|
|
1,309,486 |
|
|
|
1,360,018 |
|
Goodwill
|
|
|
898,334 |
|
|
|
898,334 |
|
Other
assets
|
|
|
283,975 |
|
|
|
283,856 |
|
Total
assets
|
|
$ |
8,165,314 |
|
|
$ |
8,797,300 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (Deficit)
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
2,979,389 |
|
|
$ |
1,806,073 |
|
Accrued
expenses and other
|
|
|
926,102 |
|
|
|
1,210,496 |
|
Deferred
revenue
|
|
|
1,319,069 |
|
|
|
1,302,600 |
|
Common
stock warrants
|
|
|
4,520,000 |
|
|
|
- |
|
Total
current liabilities
|
|
|
9,744,560 |
|
|
|
4,319,169 |
|
|
|
|
|
|
|
|
|
|
Common
stock warrants
|
|
|
9,914,823 |
|
|
|
2,923,532 |
|
Total
liabilities
|
|
|
19,659,383 |
|
|
|
7,242,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Stockholders'
equity (deficit)
|
|
|
|
|
|
|
|
|
Common
stock ($.0001 par value, 100,000,000 shares authorized, 38,174,374 and
35,383,720 issued and outstanding at September 30, 2009 and
December 31, 2008, respectively
|
|
|
3,818 |
|
|
|
3,538 |
|
Additional
paid-in capital
|
|
|
80,483,967 |
|
|
|
72,156,614 |
|
Accumulated
deficit (See Note 2
|
|
|
(91,981,854 |
) |
|
|
(70,605,553 |
) |
Total
stockholders' equity (deficit)
|
|
|
(11,494,069 |
) |
|
|
1,554,599 |
|
Total
liabilities and stockholders' equity (deficit)
|
|
$ |
8,165,314 |
|
|
$ |
8,797,300 |
|
The
accompanying notes are an integral part of these unaudited financial
statements.
SIGA
TECHNOLOGIES, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED)
|
|
Three
Months Ended
|
|
|
Nine
Months Ended
|
|
|
|
September
30,
|
|
|
September
30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$ |
3,921,938 |
|
|
$ |
1,862,557 |
|
|
$ |
9,856,674 |
|
|
$ |
5,577,055 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling,
general and administrative
|
|
|
1,522,186 |
|
|
|
945,347 |
|
|
|
5,383,626 |
|
|
|
3,115,222 |
|
Research
and development
|
|
|
4,828,010 |
|
|
|
2,853,473 |
|
|
|
12,238,255 |
|
|
|
8,189,625 |
|
Patent
preparation fees
|
|
|
191,144 |
|
|
|
198,115 |
|
|
|
384,700 |
|
|
|
461,687 |
|
Total
operating expenses
|
|
|
6,541,340 |
|
|
|
3,996,935 |
|
|
|
18,006,581 |
|
|
|
11,766,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(2,619,402 |
) |
|
|
(2,134,378 |
) |
|
|
(8,149,907 |
) |
|
|
(6,189,479 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease
(increase) in fair value of common stock rights and common stock
warrants
|
|
|
1,190,714 |
|
|
|
(912,728 |
) |
|
|
(10,517,056 |
) |
|
|
(923,217 |
) |
Other
income (expense), net
|
|
|
- |
|
|
|
18,225 |
|
|
|
662 |
|
|
|
84,775 |
|
Net
loss
|
|
$ |
(1,428,688 |
) |
|
$ |
(3,028,881 |
) |
|
$ |
(18,666,301 |
) |
|
$ |
(7,027,921 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
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|
Weighted
average shares outstanding: basic and diluted
|
|
|
37,675,381 |
|
|
|
35,109,434 |
|
|
|
36,760,793 |
|
|
|
34,525,260 |
|
Net
loss per share: basic and diluted
|
|
$ |
(0.04 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.51 |
) |
|
$ |
(0.20 |
) |
The
accompanying notes are an integral part of these unaudited financial
statements.
SIGA
TECHNOLOGIES, INC.
CONSOLIDATED
STATEMENT OF CASH FLOWS (UNAUDITED)
|
|
Nine
Months Ended
|
|
|
|
September
30, 2009
|
|
|
|
2009
|
|
|
2008
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(18,666,301 |
) |
|
$ |
(7,027,921 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
354,246 |
|
|
|
343,038 |
|
Decrease
in fair value of rights and warrants
|
|
|
10,517,056 |
|
|
|
923,217 |
|
Stock
based compensation
|
|
|
1,418,618 |
|
|
|
691,115 |
|
Changes
in assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(767,843 |
) |
|
|
(24,588 |
) |
Prepaid
expenses
|
|
|
(111,205 |
) |
|
|
(1,207,579 |
) |
Other
assets
|
|
|
(119 |
) |
|
|
(20,946 |
) |
Deferred
revenue
|
|
|
16,469 |
|
|
|
- |
|
Accounts
payable and accrued expenses
|
|
|
888,922 |
|
|
|
(72,441 |
) |
Net
cash used in operating activities
|
|
|
(6,350,157 |
) |
|
|
(6,396,105 |
) |
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Capital
expenditures
|
|
|
(303,714 |
) |
|
|
(289,339 |
) |
Net
cash used in investing activities
|
|
|
(303,714 |
) |
|
|
(289,339 |
) |
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Net
proceeds from exercise of warrants and options
|
|
|
3,274,608 |
|
|
|
2,969,936 |
|
Proceeds
from issuance of securites under Letter Agreement
|
|
|
2,500,000 |
|
|
|
- |
|
Deferred
transaction costs
|
|
|
- |
|
|
|
(159,027 |
) |
Net
cash provided by financing activities
|
|
|
5,774,608 |
|
|
|
2,810,909 |
|
Net
(decrease) increase in cash and cash equivalents
|
|
|
(879,263 |
) |
|
|
(3,874,535 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
2,321,519 |
|
|
|
6,832,290 |
|
Cash
and cash equivalents at end of period
|
|
$ |
1,442,256 |
|
|
$ |
2,957,755 |
|
The
accompanying notes are an integral part of these unaudited financial
statements.
SIGA
TECHNOLOGIES, INC.
Notes
to the September 30, 2009 Consolidated Financial Statements
(Unaudited)
SIGA
Technologies, Inc. (“SIGA” or the “Company”) is a bio-defense company mainly
engaged in the discovery, development and commercialization of products for use
in defense against biological warfare agents such as smallpox and
Arenaviruses. The Company is also engaged in the discovery and
development of other novel anti-infectives and antibiotics for the prevention
and treatment of serious infectious diseases. The Company’s
anti-viral programs are designed to prevent or limit the replication of viral
pathogens. SIGA’s anti-infectives programs target the increasingly
serious problem of drug resistant bacteria and emerging
pathogens.
The
consolidated financial statements of the Company have been prepared in
accordance with accounting principles generally accepted in the United States of
America (“U.S. GAAP”) for interim financial information and the rules and
regulations of the Securities and Exchange Commission (the “SEC”) for quarterly
reports on Form 10-Q and should be read in conjunction with the Company's
consolidated audited financial statements and notes thereto for the year ended
December 31, 2008, included in the 2008 Annual Report on Form 10-K filed on
March 6, 2009. All terms used but not defined elsewhere herein have
the meaning ascribed to them in the Company’s 2008 Annual Report on Form 10-K
filed on March 6, 2009. In the opinion of management, all adjustments
(consisting of normal and recurring adjustments) considered necessary for a fair
statement of the results of the interim periods presented have been
included. The 2008 year-end balance sheet data was derived from the
audited financial statements but does not include all disclosures required by
U.S. GAAP. The results of operations for the three and nine months
ended September 30, 2009 are not necessarily indicative of the results expected
for the full year.
The
accompanying consolidated financial statements have been prepared on a basis
which assumes that the Company will continue as a going concern and which
contemplates the realization of assets and the satisfaction of liabilities and
commitments in the normal course of business. The Company has
incurred cumulative net losses and expects to incur additional losses to perform
further research and development activities. The Company does not
currently have any product approved for sale commercially and has limited
capital resources. Management’s plans with regard to these matters
include seeking to obtain commercial contracts for the manufacturing and
delivery of the Company’s lead drug product ST-246®, continued development of
its products as well as seeking additional research support funds and future
financial arrangements. Although management will continue to pursue
these plans, there is no assurance that the Company will be successful in
obtaining sufficient future financing on commercially reasonable terms, that it
will be awarded any supply contract, or that the Company will be able to secure
funding from anticipated government contracts and grants. Management
believes that its existing cash balances combined with cash flows primarily from
proceeds from its investment commitment (see Note 3), continuing government
grants and contracts, and anticipated new government grants and contracts, will
be sufficient to support SIGA’s operations beyond the next twelve months, and
that sufficient cash flows will be available to meet the Company’s business
objectives during that period. If the Company is unable to
raise adequate capital or achieve profitability, future operations beyond the
next twelve months will need to be scaled back or
discontinued. Continuance of the Company as a going concern beyond
the next twelve months is dependent upon, among other things, the success of the
Company’s research and development programs, management’s success in obtaining
commercial contracts, and the Company’s ability to obtain adequate
financing. The financial statements do not include any adjustments
relating to the recoverability of the carrying amount of recorded assets and
liabilities that might result from the outcome of these
uncertainties.
2.
|
Significant
Accounting Policies
|
Use
of Estimates
The
consolidated financial statements and related disclosures are prepared in
conformity with U.S. GAAP. Management is required to make estimates
and assumptions that affect the reported amounts of assets and liabilities, the
disclosure of contingent assets and liabilities at the date of the financial
statements and revenue and expenses during the period reported. These
estimates include the value of options and warrants granted or issued by the
Company, the realization of deferred tax assets, and impairment of goodwill.
Estimates and assumptions are reviewed periodically and the effects of revisions
are reflected in the financial statements in the period they are determined to
be necessary. Actual results could differ from these
estimates.
Cumulative
Effect of Changes in Accounting Principles
On
January 1, 2009, the Company adopted the provisions of Financial Accounting
Standards Board (“FASB”) ASC 815-40, Derivatives and Hedging – Contracts
in Entity’s Own Equity (“ASC 815-40”). In accordance with ASC
815-40, the cumulative effect of the change in accounting principle recorded by
SIGA in connection with certain warrants to acquire shares of the Company’s
common stock (see Note 3), was recognized by SIGA as an adjustment to the
opening balance of retained earnings as summarized in the following
table:
|
|
As
reported on
December 31, 2008
|
|
|
As
adjusted on
January 1, 2009
|
|
|
Effect
of change in
accounting principle
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock warrants
|
|
$ |
- |
|
|
$ |
2,710,000 |
|
|
$ |
2,710,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
deficit
|
|
$ |
(70,605,553 |
) |
|
$ |
(73,315,553 |
) |
|
$ |
(2,710,000 |
) |
Cash
and Cash Equivalents
Cash and
cash equivalents consist of short-term, highly liquid investments, with original
maturities of less than three months when purchased and are stated at
cost. Interest is accrued as earned.
Property,
Plant and Equipment
Property,
plant and equipment are stated at cost less accumulated
depreciation. Depreciation is provided on the straight-line method
over the estimated useful lives of the various asset
classes. Estimated lives are 5 years for laboratory equipment; 3
years for computer equipment; 7 years for furniture and fixtures; and the life
of the lease for leasehold improvements. Maintenance, repairs and
minor replacements are charged to expense as incurred. Upon
retirement or disposal of assets, the cost and related accumulated depreciation
are removed from the Consolidated Balance Sheet and any gain or loss is
reflected in the Consolidated Statement of Operations.
Revenue
Recognition
The
Company recognizes revenue from contract research and development and research
payments in accordance with FASB ASC 605, Revenue Recognition, (“ASC
605”). In accordance with ASC 605, revenue is recognized when
persuasive evidence of an arrangement exists, delivery has occurred, the fee is
fixed or determinable, collectability is reasonably assured, contractual
obligations have been satisfied and title and risk of loss have been transferred
to the customer. The Company recognizes revenue from non-refundable
up-front payments, not tied to achieving a specific performance milestone, over
the period which the Company is obligated to perform services or based on the
percentage of costs incurred to date, estimated costs to complete and total
expected contract revenue. Payments for development activities are
recognized as revenue as earned, over the period of
effort. Substantive at-risk milestone payments, which are based on
achieving a specific performance milestone, are recognized as revenue when the
milestone is achieved and the related payment is due, providing there is no
future service obligation associated with that milestone. In
situations where the Company receives payment in advance of the performance of
services, such amounts are deferred and recognized as revenue as the related
services are performed.
For the
nine months ended September 30, 2009 and 2008, revenues from National Institutes
of Health (“NIH”) contracts and grants were 100% and 99%, respectively, of total
revenues recognized by the Company.
Accounts
Receivable
Accounts
receivable are recorded net of provisions for doubtful accounts. An
allowance for doubtful accounts is based on specific analysis of the
receivables. At September 30, 2009 and December 31, 2008, the Company
had no allowance for doubtful accounts.
Research
and Development
Research
and development expenses include costs directly attributable to the conduct of
research and development programs, including employee related costs, materials,
supplies, depreciation on and maintenance of research equipment, the cost of
services provided by outside contractors, and a portion of our facility costs,
such as rent, utilities, and general support services directly related to our
research and development efforts. All costs associated with research and
development are expensed as incurred. Costs related to the
acquisition of technology rights, for which development work is still in
process, and that have no alternative future uses, are expensed as incurred.
Nonrefundable advance payments for goods or services that will be used or
rendered for future research and development activities are deferred and
capitalized in accordance with FASB ASC 730-20 Research and Development – Research
and Development Arrangements.
Goodwill
Goodwill
is recorded when the purchase price paid for an acquisition exceeds the
estimated fair value of the net identified tangible and intangible assets
acquired.
The
Company evaluates goodwill for impairment annually, in the fourth quarter of
each year. In addition, the Company would test goodwill for
recoverability between annual evaluations whenever events or changes in
circumstances indicate that the carrying amounts may not be
recoverable. Examples of such events could include a significant
adverse change in legal matters, liquidity or in the business climate, an
adverse action or assessment by a regulator or government organization, loss of
key personnel, or new circumstances that would cause an expectation that it is
more likely than not that we would sell or otherwise dispose of a reporting
unit. Goodwill impairment is determined using a two-step approach in
accordance with FASB ASC 350-20 Intangibles - Goodwill and Other –
Goodwill. The impairment review process compares the fair value of the
reporting unit in which goodwill resides to its carrying value.
Income
Taxes
Income
taxes are accounted for under the asset and liability method prescribed by FASB
ASC 740 Income Taxes (“ASC
740”). Deferred income taxes are recorded for temporary
differences between financial statement carrying amounts and the tax basis of
assets and liabilities. Deferred tax assets and liabilities reflect
the tax rates expected to be in effect for the years in which the differences
are expected to reverse. A valuation allowance is provided if it is
more likely than not that some or the entire deferred tax asset will not be
realized.
The
Company applies the provisions of ASC 740 which prescribes a comprehensive model
for the manner in which a company should recognize, measure, present and
disclose in its financial statements all material uncertain tax positions that
the Company has taken or expects to take on a tax return.
The
Company has no uncertain tax positions as of December 31, 2008, and September
30, 2009. As of September 30, 2009, the only tax jurisdiction to which the
Company is subject is the United States of America. Open tax years, subject to a
taxing authority audit, relate to years in which unused net operating losses
were generated, that extend back to 1995. In the event that the Company
concludes that it is subject to interest and/or penalties arising from uncertain
tax positions, the Company will present interest and penalties as a component of
income taxes. No amounts of interest or penalties were recognized in the
Company’s Consolidated Statements of Operations or Consolidated Balance Sheets
on December 31, 2008, or as of and for the nine months ended September 30,
2009.
Net
Income per Common Share
The
Company computes, presents and discloses earnings per share in accordance with
FASB ASC 260 Earnings Per
Share (“EPS”) which specifies the computation, presentation and
disclosure requirements for earnings per share of entities with publicly held
common stock or potential common stock. The statement defines two
earnings per share calculations, basic and diluted. The objective of
basic EPS is to measure the performance of an entity over the reporting period
by dividing income (loss) by the weighted average shares
outstanding. The objective of diluted EPS is consistent with that of
basic EPS, which is to measure the performance of an entity over the reporting
period, while giving effect to all dilutive potential common shares that were
outstanding during the period. The calculation of diluted EPS is
similar to basic EPS except the denominator is increased for the conversion of
potential common shares, unless the impact of such common shares is
anti-dilutive.
The
Company incurred losses for the three and nine months ended September 30, 2009
and 2008. As a result, certain equity instruments are excluded from
the calculation of diluted loss per share. At September 30, 2009 and
2008, outstanding options to purchase 6,723,251 and 7,260,084 shares,
respectively, of the Company’s common stock with exercise prices ranging from
$0.94 to $7.85 have been excluded from the computation of diluted loss per share
as the effect of such shares is anti-dilutive. At September 30, 2009
and 2008, outstanding warrants to purchase 6,306,673 and 7,588,052 shares,
respectively, of the Company’s common stock, with exercise prices ranging from
$1.18 to $4.99 have been excluded from the computation of diluted loss per share
as they are anti-dilutive.
Fair
Value of Financial Instruments
The
carrying value of cash and cash equivalents, accounts payable and accrued
expenses approximates fair value due to the relatively short maturity of these
instruments. Common stock warrants which are classified as
liabilities under the provisions of FASB ASC 815 Derivatives and Hedging (“ASC
815”), are recorded at their fair market value as of each reporting
period.
The
Company applies FASB ASC 820 Fair value Measurements and
Disclosures (“ASC 820”) for financial assets and liabilities that are
required to be measured at fair value, and non-financial assets and liabilities
that are not required to be measured at fair value on a recurring
basis.
ASC 820
provides that the measurement of fair value requires the use of techniques based
on observable and unobservable inputs. Observable inputs reflect
market data obtained from independent sources, while unobservable inputs reflect
our market assumptions. The inputs create the following fair value
hierarchy:
|
●
|
Level
1 – Quoted prices for identical instruments in active
markets.
|
|
|
Level
2 – Quoted prices for similar instruments in active markets; quoted prices
for identical or similar instruments in markets that are not active; and
model-derived valuations where inputs are observable or where significant
value drivers are observable.
|
|
|
Level
3 – Instruments where significant value drivers are unobservable to third
parties.
|
SIGA uses
model-derived valuations where inputs are observable in active markets to
determine the fair value of certain common stock warrants on a recurring basis
and classify such warrants in Level 2. At September 30, 2009 and
December 31, 2008, the fair value of such warrants was as follows:
|
|
September 30,
2009
|
|
|
December 31,
2008
|
|
|
|
|
|
|
|
|
Common
stock warrants classified as current liabilities
|
|
$ |
4,520,000 |
|
|
$ |
- |
|
Common
stock warrants classified as long term liabilities
|
|
|
9,914,823 |
|
|
|
2,923,532 |
|
Total
|
|
$ |
14,434,823 |
|
|
$ |
2,923,532 |
|
ASC
820-10 applies to non-financial assets and non-financial liabilities measured on
a nonrecurring basis and was effective January 1, 2009. The adoption
of this standard had no impact on the Company in first quarter
2009.
Concentration
of Credit Risk
The
Company may from time to time have cash in bank accounts that exceed the Federal
Deposit Insurance Corporation insured limits. The Company has not
experienced any losses on its cash accounts. No allowance has been
provided for potential credit losses because management believes that any such
losses would be minimal. The Company’s accounts payable balance consists of
trade payables due to creditors.
Share-based
Compensation
The
Company accounts for its stock-based compensation programs under the provisions
of FASB ASC 718 Compensation –
Stock Compensation (“ASC 718”), which requires the measurement and
recognition of compensation expense for all share-based payment awards made to
employees and directors including employee stock options and employee stock
purchases related to the Employee Stock Purchase Plan (“employee stock
purchases”) based on estimated fair values. ASC 718 requires
companies to estimate the fair value of share-based awards on the grant date
using an option pricing model. The value of the portion of the award
that is ultimately expected to vest is recorded as expense over the requisite
periods in the Company’s consolidated statement of operations.
Segment
Information
The
Company is managed and operated as one business. The entire business is managed
by a single management team that reports to the chief executive officer. The
Company does not operate separate lines of business or separate business
entities with respect to any of its product candidates. Accordingly, the Company
does not prepare discrete financial information with respect to separate product
areas or by location and only has one reportable segment as defined by FASB ASC
280 Segment Reporting,
Disclosures about Segments of an Enterprise and Related
Information.
Recent
Accounting Pronouncements
In July
2009, the FASB Accounting Standards Codification (the "Codification") officially
became the single source of authoritative nongovernmental U.S. GAAP,
superseding existing FASB, American Institute of Certified Public Accountants,
the Emerging Issues Task Force, and related accounting literature. Going
forward, only one level of authoritative GAAP will exist. All other accounting
literature will be considered non-authoritative. The Codification reorganizes
the thousands of GAAP pronouncements into roughly 90 accounting topics and
displays them using a consistent structure. Also included in the Codification is
relevant SEC guidance organized using the same topical structure in separate
sections within the Codification. The Codification is effective for interim and
annual periods ending after September 15, 2009. This has had an impact to
our financial statement disclosures since all references to authoritative
accounting literature are referenced in accordance with the
Codification.
In June
2009, the FASB issued Statement No. 167, “Amendments to FASB Interpretation No.
46(R)” (“SFAS 167”). SFAS 167 eliminates FASB Interpretation No. 46(R)’s
exceptions to consolidating qualifying special-purpose entities, contains new
criteria for determining the primary beneficiary, and increases the frequency of
required reassessments to determine whether a company is the primary beneficiary
of a variable interest entity. SFAS 167 also contains a new requirement that any
term, transaction, or arrangement that does not have a substantive effect on an
entity’s status as a variable interest entity, a company’s power over a variable
interest entity, or a company’s obligation to absorb losses or its right to
receive benefits of an entity must be disregarded in applying FASB
Interpretation No. 46(R)’s provisions. SFAS 167 is effective for fiscal years
beginning after November 15, 2009. We are currently evaluating the impact of
SFAS 167 on our Condensed Consolidated Financial Statements.
In
November 2008, the FASB issued EITF 08-1, "Revenue Arrangements with Multiple
Deliverables" ("EITF 08-1"). EITF 08-1 is effective for revenue arrangements
entered into or materially modified in fiscal years beginning on or after
December 31, 2009 and shall be applied on a prospective basis. EITF 08-1
addresses some aspects of the accounting by a vendor for arrangements under
which it will perform multiple revenue-generating activities. We plan to adopt
EITF 08-1 on January 1, 2010, and we do not expect it to have a material impact
on our consolidated financial statements.
On
September 30, 2009, the Company's authorized share capital consisted of
110,000,000 shares, of which 100,000,000 are designated common shares and
10,000,000 are designated preferred shares. The Company's Board of Directors is
authorized to issue preferred shares in series with rights, privileges and
qualifications of each series determined by the Board.
2008
Financing
On June
19, 2008, SIGA entered into a letter agreement (the “Letter Agreement”), with
MacAndrews & Forbes, LLC (“M&F”), a related party, for M&F’s
commitment to invest (the “Investment Commitment”), at SIGA’s discretion, up to
$8 million over a one-year period (the “Investment Period”) in exchange for (i)
SIGA common stock at per share price equal to the lesser of (A) $3.06 and (B)
the average of the volume-weighted average price per share for the 5 trading
days immediately preceding each funding date, and (ii) warrants to purchase 40%
of the number of SIGA shares acquired by M&F, exercisable at 115% of the
common stock purchase price on such funding date (the “Consideration
Warrants”). The Consideration Warrants will be exercisable for up to
4 years following the issuance of such warrants. M&F has the
option, during the Investment Period, to invest in the Company under the same
investment terms (the “Investment Option”).
On April
29, 2009, SIGA and M&F entered into a letter agreement (the "Extension
Agreement") extending the Investment Period of the Company’s Letter Agreement
with M&F through June 19, 2010 and increasing the number of draws
pursuant to the Investment Commitment and the Investment Option to no more than
six. On April 29, 2009, SIGA notified M&F that it intends to
exercise its right to cause M&F to invest $1.5 million in SIGA pursuant to
the terms of the Letter Agreement. On April 30, 2009 the Company
issued M&F 490,196 shares of common stock and 196,078 warrants to acquire
common stock in exchange for total proceeds of $1.5
million. The warrants are exercisable until April 30,
2013, for an exercise price of $3.519 per share. On August 25, 2009, SIGA
notified M&F of its intention to exercise its right to cause M&F to
invest $1,000,000 in SIGA pursuant to the terms of the Letter Agreement. On
September 17, 2009 the Company issued M&F 326,797 shares of common stock and
130,719 warrants to acquire common stock in exchange for total proceeds of $1.0
million. The warrants are exercisable until September 17,
2013, for an exercise price of $3.519 per share. As of September 30, 2009, $5.5
million of the commitment remains outstanding.
In
addition and in consideration for the commitment of M&F, M&F received
warrants to purchase 238,000 shares of SIGA common stock, exercisable at $3.06
(the “Commitment Warrants”). The Commitment Warrants are exercisable
until June 19, 2012. The Company initially recorded all costs related
to the Letter Agreement, including the fair value of the Commitment Warrants, as
deferred transaction costs. Upon the issuance of common stock and warrants to
purchase shares of common stock on April 30, 2009, the Company recorded a
reduction in its additional paid-in capital for the effect of the related
transaction costs.
On
January 1, 2009, the Company adopted ASC 815. In accordance with the
provisions ASC 815, the warrants issuable to M&F under the Letter Agreement,
which if issued, could be exercised either by payment of cash or cashless
exercise, would no longer be considered "indexed to the Company's own stock” and
therefore would be subject to the scope of ASC 815. As a result, such
warrants meet the definition of a derivative and must be recorded on the
Company's balance sheet. The Company applied the Black-Scholes model
to calculate the fair value of the respective derivative instruments using the
Monte Carlo simulation to estimate the price of the Company’s common stock on
the derivative’s expiration date. The expected volatility was
estimated using the Company’s historical volatility. On January 1,
2009, the Company recorded the fair value of the warrants, or $2.7 million, as
an adjustment to the opening balance of retained earnings. The
Company recorded a loss of $3.5 million, or $.09 per share, for the nine months
ended September 30, 2009 representing the increase in the fair value of the
warrants from January 1, 2009 through September 30, 2009.
2006
and 2005 Placements
On
October 19, 2006, the Company sold 2,000,000 shares of the Company’s common
stock at $4.54 per share and warrants to purchase 1,000,000 shares of the
Company’s common stock. The warrants have an initial exercise price
of $4.99 per share and may be exercised at any time and from time to time
through and including the seventh anniversary of the closing date. As
of September 30, 2009, warrants to acquire 1,000,000 shares of common stock were
outstanding.
In
November 2005, the Company sold 2,000,000 shares of the Company’s common stock
at $1.00 per share and warrants to purchase 1,000,000 shares of the Company’s
common stock at an initial exercise price of $1.18 per share, and may be
exercised at any time and from time to time through and including the seventh
anniversary of the closing date. As of September 30, 2009, warrants
to acquire 579,192 shares of common stock were outstanding.
The
Company accounted for the transactions under the provisions of ASC 815 which
requires that free-standing derivative financial instruments that require net
cash settlement be classified as assets or liabilities at the time of the
transaction, and recorded at their fair value. ASC 815 also requires
that any changes in the fair value of the derivative instruments be reported in
earnings or loss as long as the derivative contracts are classified as assets or
liabilities. At September 30, 2009, the fair market value of the
warrants sold in 2006 and 2005 was $5.8 million and $4.1 million,
respectively. The Company applied the Black-Scholes model to
calculate the fair values of the respective derivative instruments using the
contracted term of the warrants. Management estimates the expected
volatility using a combination of the Company’s historical volatility and the
volatility of a group of comparable companies. SIGA recorded a loss
of $7.0 million representing the increase in the instruments’ fair value from
December 31, 2008 to September 30, 2009.
On
September 23, 2009, the Company was awarded a two-year, $1.7 million grant from
the National Institute of Allergy and Infectious Diseases (“NIAID”) of the NIH,
to support the development of broad spectrum, small-molecule inhibitors of
bunyaviruses. The grant was awarded under the American Recovery and Reinvestment
Act of 2009.
In
September 2009, SIGA received a three-year, $3.0 million Phase II grant from the
NIH to fund the continued development of ST-246® treatment of smallpox
vaccine-related adverse events.
On June
19, 2008, SIGA entered into a Letter Agreement with M&F, a related party,
for M&F’s commitment to invest, at SIGA’s discretion, up to $8 million over
a one-year period in exchange for (i) SIGA common stock, and (ii) warrants to
purchase 40% of the number of SIGA shares acquired by M&F. M&F has the
option, during the Investment Period, to invest in the Company under the same
investment terms (see Note 3).
A member
of the Company’s Board of Directors is a member of the Company’s outside
counsel. During the nine months ended September 30, 2009 and 2008,
the Company incurred costs of $1.5 million, and $491,000, respectively, related
to services provided by the outside counsel. On September 30, 2009,
the Company’s outstanding payables included $506,000 payable to the outside
counsel.
During
the nine months ended September 30, 2009, the Company incurred costs of $30,000
related to work performed by TransTech Pharma, Inc., a related party, and its
affiliates. The Company had no outstanding payables to TransTech Pharma, Inc. as
of September 30, 2009.
6.
|
Stock Compensation
Plans
|
In
January 1996, the Company implemented its 1996 Incentive and Non-Qualified Stock
Option Plan (the “Plan”). The Plan as amended provides for the
granting of up to 11,000,000 shares of the Company’s common stock to employees,
consultants and outside directors of the Company. The exercise period
for options granted under the Plan, except those granted to outside directors,
is determined by a committee of the Board of Directors. Stock options
granted to outside directors pursuant to the Plan must have an exercise price
equal to or in excess of the fair market value of the Company’s common stock at
the date of grant.
For the
nine months ended September 30, 2009 and 2008, the Company recorded compensation
expense of approximately $1.4 million and $691,000, respectively, related to
employees and directors stock options. The total fair value of
options vested during the nine months ended September 30, 2009 and 2008, was
$978,000 and
$586,000, respectively. The total compensation cost not yet
recognized related to non-vested awards at September 30, 2009, is $2.0
million. The weighted average period over which total compensation
cost is expected to be recognized is 1.6 years.
7.
|
Commitments and
Contingencies
|
In June
2009 the Company became aware that it did not comply with certain Department of
Health and Human Services (“HHS”) regulations requiring the submission of yearly
audited statements to the Office of Inspector General Office of Audit
Services. SIGA has engaged an outside audit firm to perform the
required audits and submitted all past due reports on September 30, 2009. SIGA
has asked that the Office of the Inspector General not take any enforcement
action in this matter. While there can be no assurance, the Company
currently estimates that the costs associated with potential enforcement will
not be material.
In
December 2006, PharmAthene, Inc. (“PharmAthene”) filed an action against the
Company in the Court of Chancery in the State of Delaware, captioned PharmAthene, Inc. v. SIGA
Technologies, Inc., C.A. No. 2627-N. In its Complaint, PharmAthene
asks the Court to order the Company to enter into a license agreement with
PharmAthene with respect to ST-246®, as well as issue a declaration that the
Company is obliged to execute such a license agreement, and award damages
resulting from the Company’s supposed breach of that obligation.
PharmAthene also alleges that SIGA breached an obligation to negotiate such a
license agreement in good faith, as well as seeks damages for promissory
estoppel and unjust enrichment based on supposed information, capital and
assistance that PharmAthene allegedly provided to SIGA during the negotiation
process. In January 2007, SIGA filed a motion to dismiss the Complaint in
its entirety for failure to state a claim upon which relief can be granted. In
January 2008, the Court of Chancery denied the Company’s motion to dismiss the
original complaint and lifted a related stay of discovery. On May 5, 2009,
PharmAthene amended its Complaint with respect to its claim for breach of an
obligation to negotiate in good faith and SIGA filed its Answer to
the Amended Complaint and Counterclaim on May 18,
2009. Discovery is proceeding.
As of
September 30, 2009, the Company believes that a possible loss or range of loss
cannot be reasonably estimated because PharmAthene, in its complaint, seeks
injunctive and declaratory relief as well as unspecified monetary damages and
the Company asserted what it believes to be meritorious
defenses. Therefore, the Company has concluded that it is not
possible to reasonably estimate a range of loss, if any, at this
time.
From time
to time, the Company is involved in disputes or legal proceedings arising in the
ordinary course of business. The Company believes that there is no
other dispute or litigation pending that could have, individually or in the
aggregate, a material adverse effect on its financial position, results of
operations or cash flows.
Effective
this quarter, the Company implemented FASB ASC 855 - Subsequent Events ("ASC
855"). This standard establishes general standards of accounting for and
disclosure of events that occur after the balance sheet date but before
financial statements are issued. The adoption of ASC 855 did not impact the
Company's financial position or results of operations. The Company evaluated all
events and transactions that occurred after September 30, 2009 up through
November 9, 2009, the date the Company issued these financial statements. During
this period, the Company did not have any material recognizable subsequent
events.
SIGA
TECHNOLOGIES, INC.
Item 2 – Management’s Discussion and Analysis of Financial
Condition and Results of Operations.
The
following discussion should be read in conjunction with our consolidated
financial statements and notes to those statements and other financial
information appearing elsewhere in this Quarterly Report. In addition to
historical information, the following discussion and other parts of this
Quarterly Report contain forward-looking information that involves risks and
uncertainties.
Overview
Since our
inception in December 1995, SIGA has pursued the research, development and
commercialization of novel products for the prevention and treatment of serious
infectious diseases, including products for use in the defense against
biological warfare agents such as smallpox and Arenaviruses. Our lead
product, ST-246®, is an orally administered antiviral drug that targets orthopox
viruses. In December 2005, the U.S. Food and Drug Administration (the “FDA”)
accepted our Investigational New Drug (“IND”) application for ST-246® and
granted the program “Fast-Track” status. In December 2006, the FDA granted
Orphan Drug designation to ST-246® for the prevention and treatment of
smallpox. In May 2009, we submitted a response to a Request for Proposal
(“RFP”) issued by the U.S. Biomedical Research and Development Agency (“BARDA”)
with respect to the purchase of 1.7 million courses of a smallpox antiviral (the
“BARDA Smallpox RFP”), and, in June 2009, BARDA informed us that our response to
the BARDA Smallpox RFP was deemed technically acceptable and in the competitive
range. There can be no assurance that SIGA or any other company will
receive an award pursuant to this RFP. Further, any award on this RFP would be
subject to negotiation of final contract terms and specifications; thus, the
final terms under any contract with BARDA may be materially different than those
indicated in the RFP.
Our
anti-viral programs are designed to prevent or limit the replication of the
viral pathogen. Our anti-infectives programs are aimed at the
increasingly serious problem of drug resistance. These programs are designed to
block the ability of bacteria to attach to human tissue, the first step in the
infection process. As a result of the success of our efforts to
develop products for use against agents of biological warfare, we have not spent
significant resources to further the development of our anti-infective
technologies.
We do not
currently have any product approved for sale commercially, and we cannot predict
with certainty when our products will be able to be sold in substantial
quantities. We will need additional funds to complete the development
of our products. Our plans with regard to these matters include
responding to current and future RFPs and seeking to obtain commercial contracts
for the manufacturing and delivery of ST-246®, continued development of our
products as well as seeking additional capital through a combination of
collaborative agreements, strategic alliances, research grants, and future
equity and debt financing. Although we continue to pursue these
plans, there is no assurance that we will be successful in obtaining future
financing on commercially reasonable terms, that we will be awarded any supply
contract, or that we will be able to secure funding from anticipated government
contracts and grants.
Management
believes that its existing cash balances combined with cash flows primarily from
proceeds from our investment commitment, continuing government grants and
contracts, and anticipated new government grants and contracts, will be
sufficient to support SIGA’s operations beyond the next twelve months, and that
sufficient cash flows will be available to meet the Company’s business
objectives during that period. We believe that we have
sufficient liquidity to support our operations beyond the next twelve months
despite the disruption of the capital markets. We are not dependent
on the availability of short-term debt facilities and the limited availability
of credit in the market has not affected our liquidity or materially affected
our funding.
Our
technical operations are based in our research facility in Corvallis,
Oregon. We continue to seek to fund a major portion of our ongoing
antiviral, antibiotic and vaccine programs through a combination of government
grants, contracts and strategic alliances. While we have had success
in obtaining strategic alliances, contracts and grants, there is no assurance
that we will continue to be successful in obtaining funds from these
sources. Until additional relationships are established, we expect to
continue to incur significant research and development (“R&D”) costs and
costs associated with the manufacturing of product for use in clinical trials
and pre-clinical testing. It is expected that general and
administrative costs, including patent and regulatory costs, necessary to
support clinical trials and R&D will continue to be significant in the
future. We may incur operating losses for the foreseeable future, and
there can be no assurance that we will ever achieve profitable
operations.
Critical
Accounting Policies and Estimates
Following
is a brief discussion of the more significant accounting policies and methods
used by us in the preparation of our consolidated financial
statements. Note 2 of the Notes to the Consolidated Financial
Statements includes a summary of all of the significant accounting policies.
There were no significant changes to the critical accounting policies described
in the 2008 Annual Report on Form 10-K other than the cumulative effect of
changes in accounting principles as noted below.
Cumulative
Effect of Changes in Accounting Principles
On
January 1, 2009, the Company adopted the provisions of ASC 815. In
accordance with ASC 815, the cumulative effect of the change in accounting
principle recorded by SIGA in connection with certain warrants to acquire shares
of the company’s common stock (see Note 3) was recognized by SIGA as an
adjustment to the opening balance of retained earnings as summarized in the
following table:
|
|
As
reported on
December
31,2008
|
|
|
As
adjusted on
January
1, 2009
|
|
|
Effect
of change in
accounting
principle
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock warrants
|
|
$ |
- |
|
|
$ |
2,710,000 |
|
|
$ |
2,710,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
deficit
|
|
$ |
(70,605,553 |
) |
|
$ |
(73,315,553 |
) |
|
$ |
(2,710,000 |
) |
Results
of Operations
Three
months ended September 30, 2009 and 2008
Revenue
from R&D contracts and grants for the three months ended September 30, 2009
was $3.9 million, an increase of $2.0 million or 111% from the $1.9 million
recognized during the same period in the prior year. Revenue recognized from our
program for the large-scale manufacturing and packaging of ST-246® increased by
$1.6 million, and revenue recognized from our $55 million contract with the NIH
to support the development of additional formulations and orthopox-related
indications of ST-246® increased by $526,000.
Selling,
general and administrative expenses (“SG&A”) for the three months ended
September 30, 2009 and 2008 were $1.5 million and $945,000, respectively,
reflecting an increase of approximately $576,000 or 61%. Higher
SG&A expenses for the three month period in 2009 are mainly due
to an increase of $205,000 in accounting services resulting from additional
governmental audits, an increase of $80,000 in stock based compensation charges,
a $34,000 increase in insurance premiums related to the Company’s expanded
research operations and higher market capitalization, and an increase of
$223,000 in legal and litigation support incurred during the three months ended
September 30, 2009, from the same period in 2008.
R&D
expenses for the three months ended September 30, 2009 and 2008 were $4.8
million and $2.9 million, respectively. The increase of approximately
$2.0 million or 69% is due to a $1.8 million increase in expenses related to our
leading drug development programs, as well as an increase of $105,000 in
employee compensation expenses mainly related to the hiring of additional
R&D support personnel. As of September 30, 2009 and 2008, the Company had 45
and 36 full time R&D employees, respectively.
During
the three months ended September 30, 2009 and 2008, we spent $3.1 and $1.2
million, respectively, on the development of our lead drug candidate,
ST-246®. For the three months ended September 30, 2009, we spent
$381,000 on internal human resources and $2.7 million mainly on manufacturing
and clinical testing. For the three months ended September 30, 2008,
we spent $330,000 on internal human resources and $870,000 mainly on clinical
testing. From inception of the ST-246® development program to-date,
we expended a total of $22.5 million related to the program, of which $4.8
million and $17.7 million were spent on internal human resources, and
manufacturing, clinical and pre-clinical work, respectively. These
resources reflect SIGA’s R&D expenses directly related to the
program. They exclude additional expenditures such as the cost to
acquire the program, patent costs, allocation of indirect expenses, and the
value of other services received from the NIH and the Department of Defense
(“DoD”).
During
the three months ended September 30, 2009 and 2008, we spent $96,000 and
$243,000, respectively, to support the development of ST-193, a drug candidate
for Lassa fever virus, ST-294, a drug candidate for certain arenavirus
pathogens, and other drug candidates for hemorrhagic fevers. For the three
months ended September 30, 2009, we spent $37,000 on internal human resources
and $59,000 mainly on pre-clinical testing of our drug
candidates. For the three months ended September 30, 2008, we spent
$62,000 on internal human resources and $181,000 on pre-clinical
testing. From inception of our program to develop ST-193, ST-294 and
other drug candidates for hemorrhagic fevers, to-date, we spent a total of $5.8
million related to the program, of which $2.2 million and $3.6 million were
expended on internal human resources and pre-clinical work,
respectively. These resources reflect SIGA’s research and development
expenses directly related to the program. They exclude additional
expenditures such as the cost to acquire the program, patent costs, allocation
of indirect expenses, and the value of other services received from the NIH and
the DoD.
Patent
preparation expenses decreased to $191,000 for the three months ended September
30, 2009, from $198,000 for the same period in the prior year. Higher
costs in 2008 reflect timing of patent filings related to our efforts to protect
our lead drug candidates in expanded geographic territories.
Changes
in the fair value of certain warrants to acquire common stock are recorded as
gains or losses. For the three months ended September 30, 2009 and
2008, we recorded a gain of $1.2 million and a loss of $913,000, respectively,
reflecting changes in the fair market value of warrants to purchase common stock
during the respective three month periods.
Other
income of $18,000 recorded for the three months ended September 30, 2008,
reflected interest income on our cash and cash equivalent
balance. During the three months ended September 30, 2009, the
majority of our cash and cash equivalent balance was invested in non-interest
bearing accounts.
Nine
months ended September 30, 2009 and 2008
Revenues
from R&D contracts and grants for the nine months ended September 30, 2009
and 2008 were $9.9 million and $5.6 million, respectively, reflecting an
increase of $4.3 million or 77% which is mainly due to expanded activities
supporting the development of ST-246®. For the nine months ended
September 30, 2009, we recorded $8.9 million from grants and contracts
supporting the development of our lead drug candidate, ST-246® and its
alternative formulations. Revenue from grants and contracts
supporting these programs during the same period in 2008 was $4.2
million.
SG&A
expenses increased $2.3 million or 73% to $5.4 million for the nine months ended
September 30, 2009, from $3.1 million for the same period in
2008. The increase relates mainly to $655,000 of higher stock based
compensation charges, $177,000 increase in accounting services, and an increase
of $1.2 million in legal and litigation support.
R&D
expenses were $12.2 million for the nine months ended September 30, 2009, an
increase of $4.0 million or 49% from the $8.2 million spent during the nine
months ended September 30, 2008. Expenditures related to the
development of our lead drug candidates increased $3.3 million from the same
period in the prior year. Employee compensation expenses increased $654,000
mainly due to the hiring of additional R&D support personnel. As of
September 30, 2009 and 2008, the Company had 45 and 36 full time R&D
employees, respectively.
During
the nine months ended September 30, 2009 and 2008, we spent $7.6 million and
$3.7 million, respectively, on the development of ST-246. For the
nine months ended September 30, 2009, we spent $1.2 million on internal human
resources and $6.4 million mainly on manufacturing and clinical
testing. For the nine months ended September 30, 2008, we spent
$850,000 on internal human resources and $2.9 million mainly on clinical
testing. From inception of the ST-246® development program to-date,
we expended a total of $22.5 million related to the program, of which $4.8
million and $17.7 million were spent on internal human resources, and clinical
and pre-clinical work, respectively. These resources reflect SIGA’s
R&D expenses directly related to the program. They exclude
additional expenditures such as the cost to acquire the program, patent costs,
allocation of indirect expenses, and the value of other services received from
the NIH and the DoD.
R&D
expenses of $347,000 and $760,000 during the nine months ended September 30,
2009 and 2008, respectively, were used to support the development of ST-193, a
drug candidate for Lassa fever virus, ST-294, a drug candidate for certain arena
virus pathogens, and other drug candidates for hemorrhagic fevers. For the nine
months ended September 30, 2009, we spent $143,000 on internal human resources
and $204,000 mainly on pre-clinical testing. For the nine months
ended September 30, 2008, we spent $190,000 on internal human resources and
$570,000 mainly on pre-clinical testing. From inception of our
program to develop ST-294 and other drug candidates for hemorrhagic fevers,
to-date, we spent a total of $5.8 million related to the program, of which $2.2
million and $3.6 million were expended on internal human resources and
pre-clinical work, respectively. These resources reflect SIGA’s
R&D expenses directly related to the program. They exclude
additional expenditures such as the cost to acquire the program, patent costs,
allocation of indirect expenses, and the value of other services received from
the NIH and the DoD.
Patent
preparation expenses for the nine months ended September 30, 2009 and 2008 were
$385,000 and $462,000, respectively. Higher costs in 2008 reflect timing of
patents filings related to our efforts to protect our lead drug candidates in
expanded geographic territories.
Changes
in the fair value of certain warrants to acquire common stock are recorded as
gains or losses. For the nine months ended September 30, 2009 and
2008, we recorded losses of $10.5 million and $923,000, respectively, reflecting
changes in the fair market value of warrants to purchase common stock during the
respective nine month periods.
For the
nine months ended September 30, 2009 and 2008, we recorded other income of
$1,000 and $85,000, respectively, mainly related to interest income on our cash
and cash equivalent balance. The decline in other income is due to
lower average cash and cash equivalent balance during the nine months ended
September 30, 2009 as compared to the same period in the prior
year.
Liquidity
and Capital Resources
On
September 30, 2009, we had approximately $1.4 million in cash and cash
equivalents.
Operating
activities
Net cash
used in operations during the nine months ended September 30, 2009 and 2008 was
approximately $6.4 million. For the nine months ended September 30, 2008, we
used $1.25 million for a deposit paid to a third party under an agreement to
manufacture ST-246® for testing.
On
September 23, 2009, the Company was awarded a two-year, $1.7 million grant from
the National Institute of Allergy and Infectious Diseases (“NIAID”) of the NIH,
to support the development of broad spectrum, small-molecule inhibitors of
bunyaviruses. The grant was awarded under the American Recovery and Reinvestment
Act of 2009.
In
September 2009, SIGA received a three-year, $3.0 million Phase II grant from the
NIH to fund the continued development of ST-246® treatment of smallpox
vaccine-related adverse events.
Investing
activities
Capital
expenditures of $304,000 and $289,000 during the nine months ended September 30,
2009 and 2008 mainly supported acquisitions of laboratory and computer
equipment.
Financing
activities
Cash
provided by financing activities during the nine months ended September 30, 2009
and 2008 was $5.8 million and $2.8 million, respectively, generated from
exercises of options and warrants to purchase common stock as well as
investments made under SIGA’s Letter Agreement with MacAndrews & Forbes, LLC
(“M&F”).
On June
19, 2008, we entered into a letter agreement (the “Letter Agreement”), with
MacAndrews & Forbes, LLC (“M&F”), a related party, for M&F’s
commitment to invest (the “Investment Commitment”), at SIGA’s discretion, up to
$8 million over a one-year period (the “Investment Period”) in exchange for (i)
SIGA common stock at per share price equal to the lesser of (A) $3.06 and (B)
the average of the volume-weighted average price per share for the 5 trading
days immediately preceding each funding date, and (ii) warrants to purchase 40%
of the number of SIGA shares acquired by M&F, exercisable at 115% of the
common stock purchase price on such funding date (the “Consideration
Warrants”). The Consideration Warrants will be exercisable for up to
four years following the issuance of such warrants. M&F has the
option, during the Investment Period, to invest in the Company under the same
investment terms (the “Investment Option”).
On April
29, 2009, SIGA and M&F entered into a letter agreement (the "Extension
Agreement") extending the Investment Period of the Company’s Letter Agreement
with M&F through June 19, 2010 and increasing the number of draws pursuant
to the Investment Commitment and the Investment Option to no more than
nine. On April 29, 2009, we notified M&F of our intention to
exercise our right to cause M&F to invest $1.5 million in SIGA pursuant to
the terms of the Letter Agreement. On April 30, 2009, we issued
M&F 490,196 shares of common stock and 196,078 warrants to acquire common
stock in exchange for total proceeds of $1.5 million. The warrants
are exercisable until April 30, 2013, for an exercise price of $3.519 per
share. The proceeds of the investment will be used for general
corporate purposes. On August 25, 2009, SIGA notified M&F of its
intention to exercise its right to cause M&F to invest $1,000,000 in SIGA
pursuant to the terms of the Letter Agreement. On September 17, 2009 the Company
issued M&F 326,797 shares of common stock and 130,719 warrants to acquire
common stock in exchange for total proceeds of $1.0
million. The warrants are exercisable until September 17,
2013, for an exercise price of $3.519 per share. As of September 30, 2009, $5.5
million of the commitment remains outstanding.
Other
We have
incurred cumulative net losses and may incur additional losses as we perform
further research and development activities. We do not currently have any
product approved for sale commercially and currently have limited capital
resources. Our plans with regard to these matters include responding to current
and future RFPs and seeking to obtain commercial contracts for the manufacture
and delivery of ST-246, continued development of our products as well as seeking
additional working capital through a combination of collaborative agreements,
strategic alliances, research grants, and future equity and debt financing.
Although we continue to pursue these plans, there is no assurance that we will
be successful in any of these activities, including no assurance that we will be
awarded any supply contract, obtain future financing on commercially reasonable
terms, that we will be awarded any supply contract, or be able to secure funding
from anticipated government contracts and grants.
We
believe that our existing cash balances combined with cash flows primarily from
proceeds from our investment commitment, continuing government grants and
contracts, and anticipated new government grants and contracts will be
sufficient to support our operations beyond the next twelve months, and that
sufficient cash flows will be available to meet our business objectives during
that period. We believe that we have sufficient liquidity to support our
operations beyond the next twelve months despite the disruption of the capital
markets. We are not dependent on the availability of short-term debt facilities
and the limited availability of credit in the market has not affected our
liquidity or materially impacted our funding.
Our
working capital and capital requirements will depend upon numerous factors,
including whether we are successful in obtaining government-funded contracts for
the manufacture and delivery of ST-246; whether the terms of any such contract
are commercially favorable; the progress, if any, and the future needs of our
pharmaceutical R&D programs; pre-clinical and clinical testing activity; the
timing and cost of obtaining regulatory approvals; the levels of resources that
we devote to the development of manufacturing and marketing capabilities;
technological advances; the status of competitors; and our ability to establish
collaborative arrangements with other organizations.
Off-Balance
Sheet Arrangements
SIGA does
not have any off-balance sheet arrangements.
Safe
Harbor Statement
This
report contains certain "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended, including
statements regarding the efficacy of potential products, the timelines for
bringing such products to market and the availability of funding sources for
continued development of such products. Forward-looking statements are based on
management's estimates, assumptions and projections, and are subject to
uncertainties, many of which are beyond the control of SIGA. Actual results may
differ materially from those anticipated in any forward-looking statement.
Factors that may cause such differences include (i) the risks that potential
products that appear promising to SIGA or its collaborators cannot be shown to
be efficacious or safe in subsequent pre-clinical or clinical trials, (ii) the
risk that SIGA or its collaborators will not obtain appropriate or necessary
governmental approvals to market these or other potential products, (iii) the
risk that SIGA may not be able to obtain anticipated funding for its development
projects or other needed funding, (iv) the risk that SIGA may not be able to
secure funding from anticipated government contracts and grants, (v) the risk
that SIGA may not be able to secure or enforce adequate legal protection,
including patent protection, for its products, (vi) the risk that regulatory
approval for SIGA’s products may require further or additional testing that will
delay or prevent approval, (vii) the Biomedical Advanced Research &
Development Authority may not complete the procurement set forth in a
solicitation for the acquisition of a smallpox antiviral for the strategic
national stockpile, or may complete it on different terms, (viii) the volatile
and competitive nature of the biotechnology industry, (ix) changes in domestic
and foreign economic and market conditions, and (x) the effect of
federal, state and foreign regulation on SIGA’s businesses. More detailed
information about SIGA and risk factors that may affect the realization of
forward-looking statements, including the forward-looking statements in this
presentation, is set forth in SIGA's filings with the Securities and Exchange
Commission, including SIGA's Annual Report on Form 10-K, for the fiscal year
ended December 31, 2008, and in other documents that SIGA has filed with the
Commission. SIGA urges investors and security holders to read those documents
free of charge at the Commission's Web site at http://www.sec.gov. Interested
parties may also obtain those documents free of charge from SIGA.
Forward-looking statements speak only as of the date they are made, and except
for our ongoing obligations under the United States of America federal
securities laws, we undertake no obligation to publicly update any
forward-looking statements whether as a result of new information, future events
or otherwise.
Item 3 – Quantitative and Qualitative Disclosures About Market
Risk.
None.
Item 4 – Controls and Procedures.
(a) Disclosure
Controls and Procedures. The Company's management, with the
participation of the Company's Chief Executive Officer and Chief Financial
Officer, has evaluated the effectiveness of the Company's disclosure controls
and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange
Act) as of the end of the fiscal period covered by this Quarterly Report on Form
10-Q. Based upon such evaluation, the Chief Executive Officer and
Chief Financial Officer have concluded that, as of the end of such period, the
Company's disclosure controls and procedures are effective.
(b) Changes
in Internal Control Over Financial Reporting. There have not been any
changes in the Company's internal control over financial reporting (as such term
is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the
fiscal period covered by this Quarterly Report on Form 10-Q that have materially
affected, or are reasonably likely to materially affect, the Company's internal
control over financial reporting.
PART
II – OTHER INFORMATION
In
December 2006, PharmAthene, Inc. (“PharmAthene”) filed an action against the
Company in the Court of Chancery in the State of Delaware, captioned PharmAthene, Inc. v. SIGA
Technologies, Inc., C.A. No. 2627-N. In its Complaint, PharmAthene
asks the Court to order the Company to enter into a license agreement with
PharmAthene with respect to ST-246®, as well as issue a declaration that the
Company is obliged to execute such a license agreement, and award damages
resulting from the Company’s supposed breach of that obligation.
PharmAthene also alleges that SIGA breached an obligation to negotiate such a
license agreement in good faith, as well as seeks damages for promissory
estoppel and unjust enrichment based on supposed information, capital and
assistance that PharmAthene allegedly provided to SIGA during the negotiation
process. In January 2007, SIGA filed a motion to dismiss the Complaint in
its entirety for failure to state a claim upon which relief can be granted. In
January 2008, the Court of Chancery denied the Company’s motion to dismiss the
original complaint and lifted a related stay of discovery. On May 5, 2009, PharmAthene amended its Complaint with
respect to its claim for breach of an obligation to negotiate in good faith and
SIGA filed its Answer to the Amended Complaint and Counterclaim on May 18,
2009. Discovery is proceeding.
There are
no material changes to the Risk Factors disclosed in our Annual report on Form
10-K for the fiscal year ended December 31, 2008.
|
Unregistered
Sale of Equity Securities and Use of
Proceeds.
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None.
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Defaults
upon Senior Securities.
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None.
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Submission
of Matters to a Vote of Security
Holders.
|
None.
None.
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Certification
of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
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|
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Certification
of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
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|
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Certification
of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
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|
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Certification
of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
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* Filed
herein
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
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SIGA
Technologies, Inc.
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(Registrant)
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Date:
November 9, 2009
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By: /s/
Ayelet
Dugary
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Ayelet
Dugary
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Chief
Financial Officer
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20