|
x
|
Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
|
For the Quarterly Period Ended September 30, 2019
|
|
Or
|
¨
|
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
|
For the transition period from ________ to ___________
|
Delaware
|
13-3864870
|
(State or other jurisdiction of
|
(IRS Employer Identification. No.)
|
incorporation or organization)
|
|
|
|
31 East 62nd Street
|
10065
|
New York, NY
|
(zip code)
|
(Address of principal executive offices)
|
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
common stock, $.0001 par value
|
SIGA
|
The Nasdaq Global Market
|
Large accelerated filer ¨
|
|
Accelerated filer x
|
Non-accelerated filer ¨
|
|
Smaller reporting company ¨
|
|
|
Emerging growth company ¨
|
|
|
|
Page No.
|
|
|
|
|
|
September 30, 2019
|
|
December 31, 2018
|
||||
ASSETS
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
78,095,231
|
|
|
$
|
100,652,809
|
|
Restricted cash, short-term
|
11,053,200
|
|
|
11,452,078
|
|
||
Accounts receivable
|
3,217,701
|
|
|
1,959,133
|
|
||
Inventory
|
3,931,161
|
|
|
2,908,210
|
|
||
Prepaid expenses and other current assets
|
2,324,439
|
|
|
4,317,615
|
|
||
Total current assets
|
98,621,732
|
|
|
121,289,845
|
|
||
|
|
|
|
||||
Property, plant and equipment, net
|
2,749,758
|
|
|
171,274
|
|
||
Restricted cash, long-term
|
87,079,574
|
|
|
68,292,023
|
|
||
Deferred tax assets, net
|
12,799,060
|
|
|
11,733,385
|
|
||
Goodwill
|
898,334
|
|
|
898,334
|
|
||
Other assets
|
862,979
|
|
|
1,058,880
|
|
||
Total assets
|
$
|
203,011,437
|
|
|
$
|
203,443,741
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
2,251,814
|
|
|
$
|
1,688,488
|
|
Accrued expenses and other current liabilities
|
9,544,060
|
|
|
9,648,917
|
|
||
Total current liabilities
|
11,795,874
|
|
|
11,337,405
|
|
||
Warrant liability
|
6,433,427
|
|
|
12,380,939
|
|
||
Other liabilities
|
3,004,313
|
|
|
1,263,113
|
|
||
Long-term debt
|
78,911,307
|
|
|
75,547,597
|
|
||
Total liabilities
|
100,144,921
|
|
|
100,529,054
|
|
||
Commitments and contingencies
|
|
|
|
||||
Stockholders’ equity
|
|
|
|
||||
Common stock ($.0001 par value, 600,000,000 shares authorized, 81,074,280 and 80,763,350 issued and outstanding at September 30, 2019, and December 31, 2018, respectively)
|
8,107
|
|
|
8,076
|
|
||
Additional paid-in capital
|
221,388,212
|
|
|
218,697,872
|
|
||
Accumulated deficit
|
(118,529,803
|
)
|
|
(115,791,261
|
)
|
||
Total stockholders’ equity
|
102,866,516
|
|
|
102,914,687
|
|
||
Total liabilities and stockholders’ equity
|
$
|
203,011,437
|
|
|
$
|
203,443,741
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenues
|
|
|
|
|
|
|
|
||||||||
Product sales and supportive services
|
$
|
3,915,335
|
|
|
$
|
468,865,229
|
|
|
$
|
11,057,735
|
|
|
$
|
468,865,229
|
|
Research and development
|
4,195,989
|
|
|
2,210,095
|
|
|
11,420,284
|
|
|
6,619,245
|
|
||||
Total revenues
|
8,111,324
|
|
|
471,075,324
|
|
|
22,478,019
|
|
|
475,484,474
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Operating expenses
|
|
|
|
|
|
|
|
||||||||
Cost of sales and supportive services
|
737,274
|
|
|
95,166,271
|
|
|
1,652,641
|
|
|
95,166,271
|
|
||||
Selling, general and administrative
|
3,196,370
|
|
|
3,114,678
|
|
|
9,755,165
|
|
|
9,051,617
|
|
||||
Research and development
|
3,343,521
|
|
|
3,723,198
|
|
|
9,379,125
|
|
|
10,043,205
|
|
||||
Patent expenses
|
173,580
|
|
|
186,028
|
|
|
543,806
|
|
|
582,833
|
|
||||
Total operating expenses
|
7,450,745
|
|
|
102,190,175
|
|
|
21,330,737
|
|
|
114,843,926
|
|
||||
Operating income
|
660,579
|
|
|
368,885,149
|
|
|
1,147,282
|
|
|
360,640,548
|
|
||||
Gain (loss) from change in fair value of warrant liability
|
981,923
|
|
|
(2,328,674
|
)
|
|
4,774,711
|
|
|
(5,271,503
|
)
|
||||
Interest expense
|
(3,971,952
|
)
|
|
(3,924,124
|
)
|
|
(11,871,401
|
)
|
|
(11,516,103
|
)
|
||||
Other income, net
|
759,881
|
|
|
5,067
|
|
|
2,233,588
|
|
|
151,454
|
|
||||
(Loss)/income before income taxes
|
(1,569,569
|
)
|
|
362,637,418
|
|
|
(3,715,820
|
)
|
|
344,004,396
|
|
||||
Benefit for income taxes
|
363,742
|
|
|
25,412,995
|
|
|
977,278
|
|
|
25,412,498
|
|
||||
Net and comprehensive (loss)/income
|
$
|
(1,205,827
|
)
|
|
$
|
388,050,413
|
|
|
$
|
(2,738,542
|
)
|
|
$
|
369,416,894
|
|
Basic (loss)/income per share
|
$
|
(0.01
|
)
|
|
$
|
4.85
|
|
|
$
|
(0.03
|
)
|
|
$
|
4.64
|
|
Diluted (loss)/income per share
|
$
|
(0.03
|
)
|
|
$
|
4.71
|
|
|
$
|
(0.09
|
)
|
|
$
|
4.53
|
|
Weighted average shares outstanding: basic
|
81,064,927
|
|
|
80,023,044
|
|
|
80,988,813
|
|
|
79,650,373
|
|
||||
Weighted average shares outstanding: diluted
|
82,181,858
|
|
|
82,929,476
|
|
|
82,148,333
|
|
|
82,744,227
|
|
|
|
Nine months ended September 30,
|
||||||
|
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
|
||||
Net (loss)/income
|
|
$
|
(2,738,542
|
)
|
|
$
|
369,416,894
|
|
Adjustments to reconcile net (loss)/income to net cash used in operating activities:
|
|
|
|
|
||||
Depreciation and other amortization
|
|
395,540
|
|
|
48,639
|
|
||
(Decrease)/increase in fair value of warrant liability
|
|
(4,774,711
|
)
|
|
5,271,503
|
|
||
Stock-based compensation
|
|
1,717,380
|
|
|
1,866,279
|
|
||
Deferred income taxes benefit
|
|
(1,065,675
|
)
|
|
(25,520,615
|
)
|
||
Net realization of deferred revenue and costs due to FDA approval of oral TPOXX®
|
|
—
|
|
|
(281,950,853
|
)
|
||
Non-cash interest expense
|
|
3,363,712
|
|
|
3,363,712
|
|
||
Changes in assets and liabilities:
|
|
|
|
|
||||
Accounts receivable
|
|
(1,258,568
|
)
|
|
369,872
|
|
||
Inventory
|
|
(1,022,951
|
)
|
|
—
|
|
||
Prepaid expenses and other assets
|
|
2,189,076
|
|
|
567,042
|
|
||
Accounts payable, accrued expenses and other liabilities
|
|
(697,325
|
)
|
|
(969,951
|
)
|
||
Deferred revenue
|
|
(47,939
|
)
|
|
—
|
|
||
Net cash (used in)/provided by operating activities
|
|
(3,940,003
|
)
|
|
72,462,522
|
|
||
Cash flows from investing activities:
|
|
|
|
|
||||
Capital expenditures
|
|
(29,092
|
)
|
|
(27,863
|
)
|
||
Net cash used in investing activities
|
|
(29,092
|
)
|
|
(27,863
|
)
|
||
Cash flows from financing activities:
|
|
|
|
|
||||
Net proceeds from exercise of stock options
|
|
—
|
|
|
252,679
|
|
||
Payment of employee tax obligations for common stock tendered
|
|
(199,810
|
)
|
|
(1,708,290
|
)
|
||
Net cash used in financing activities
|
|
(199,810
|
)
|
|
(1,455,611
|
)
|
||
Net (decrease)/increase in cash, cash equivalents and restricted cash
|
|
(4,168,905
|
)
|
|
70,979,048
|
|
||
Cash, cash equivalents and restricted cash at the beginning of period
|
|
180,396,910
|
|
|
37,101,586
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
|
$
|
176,228,005
|
|
|
$
|
108,080,634
|
|
|
|
|
|
|
||||
Supplemental disclosure of non-cash activities:
|
|
|
|
|
||||
Conversion of warrants to common stock
|
|
$
|
1,172,801
|
|
|
$
|
6,007,847
|
|
Issuance of common stock upon cashless exercise
|
|
$
|
118,500
|
|
|
$
|
1,582,420
|
|
|
|
As of
|
||||||
|
|
September 30, 2019
|
|
December 31, 2018
|
||||
Cash and cash equivalents
|
|
$
|
78,095,231
|
|
|
$
|
100,652,809
|
|
Restricted cash-short term
|
|
11,053,200
|
|
|
11,452,078
|
|
||
Restricted cash-long term
|
|
87,079,574
|
|
|
68,292,023
|
|
||
Cash, cash equivalents and restricted cash
|
|
$
|
176,228,005
|
|
|
$
|
180,396,910
|
|
|
|
|
|
|
||||
|
|
September 30, 2018
|
|
December 31, 2017
|
||||
Cash and cash equivalents
|
|
$
|
103,985,265
|
|
|
$
|
19,857,833
|
|
Restricted cash-short term
|
|
4,095,369
|
|
|
10,701,305
|
|
||
Restricted cash-long term
|
|
—
|
|
|
6,542,448
|
|
||
Cash, cash equivalents and restricted cash
|
|
$
|
108,080,634
|
|
|
$
|
37,101,586
|
|
|
As of
|
||||||
|
September 30, 2019
|
|
December 31, 2018
|
||||
Work in-process
|
$
|
2,970,182
|
|
|
$
|
1,950,445
|
|
Finished goods
|
960,979
|
|
|
957,765
|
|
||
Inventory
|
$
|
3,931,161
|
|
|
$
|
2,908,210
|
|
|
As of
|
||||||
|
September 30, 2019
|
|
December 31, 2018
|
||||
Leasehold improvements
|
$
|
2,420,028
|
|
|
$
|
2,420,028
|
|
Computer equipment
|
601,797
|
|
|
618,248
|
|
||
Furniture and fixtures
|
377,859
|
|
|
377,859
|
|
||
Operating lease right-of-use assets
|
2,944,932
|
|
|
—
|
|
||
|
6,344,616
|
|
|
3,416,135
|
|
||
Less - accumulated depreciation and amortization
|
(3,594,858
|
)
|
|
(3,244,861
|
)
|
||
Property, plant and equipment, net
|
$
|
2,749,758
|
|
|
$
|
171,274
|
|
|
As of
|
||||||
|
September 30, 2019
|
|
December 31, 2018
|
||||
Bonus
|
$
|
2,016,001
|
|
|
$
|
2,600,839
|
|
Deferred revenue
|
4,112,007
|
|
|
4,159,946
|
|
||
Interest payable
|
968,018
|
|
|
35,567
|
|
||
Lease liability, current portion
|
412,436
|
|
|
—
|
|
||
Research and development vendor costs
|
517,618
|
|
|
1,446,410
|
|
||
Professional fees
|
368,218
|
|
|
242,043
|
|
||
Vacation
|
297,103
|
|
|
294,794
|
|
||
Other
|
852,659
|
|
|
869,318
|
|
||
Accrued expenses and other current liabilities
|
$
|
9,544,060
|
|
|
$
|
9,648,917
|
|
•
|
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.
|
|
Fair Value Measurements of Level 3 liability-classified warrant
|
||
Warrant liability at December 31, 2018
|
$
|
12,380,939
|
|
Decrease in fair value of warrant liability
|
(4,774,711
|
)
|
|
Exercise of warrants
|
(1,172,801
|
)
|
|
Warrant liability at September 30, 2019
|
$
|
6,433,427
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net (loss)/income for basic earnings per share
|
$
|
(1,205,827
|
)
|
|
$
|
388,050,413
|
|
|
$
|
(2,738,542
|
)
|
|
$
|
369,416,894
|
|
Less: Change in fair value of warrants
|
981,923
|
|
|
(2,328,674
|
)
|
|
4,774,711
|
|
|
(5,271,503
|
)
|
||||
Net (loss)/income, adjusted for change in fair value of warrants for diluted earnings per share
|
$
|
(2,187,750
|
)
|
|
$
|
390,379,087
|
|
|
$
|
(7,513,253
|
)
|
|
$
|
374,688,397
|
|
Weighted-average shares
|
81,064,927
|
|
|
80,023,044
|
|
|
80,988,813
|
|
|
79,650,373
|
|
||||
Effect of potential common shares
|
1,116,931
|
|
|
2,906,432
|
|
|
1,159,520
|
|
|
3,093,854
|
|
||||
Weighted-average shares: diluted
|
82,181,858
|
|
|
82,929,476
|
|
|
82,148,333
|
|
|
82,744,227
|
|
||||
(Loss)/income per share: basic
|
$
|
(0.01
|
)
|
|
$
|
4.85
|
|
|
$
|
(0.03
|
)
|
|
$
|
4.64
|
|
(Loss)/income per share: diluted
|
$
|
(0.03
|
)
|
|
$
|
4.71
|
|
|
$
|
(0.09
|
)
|
|
$
|
4.53
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||
|
2019
|
|
2019
|
||
Stock Options
|
332,861
|
|
|
353,801
|
|
Stock-Settled Stock Appreciation Rights
|
—
|
|
|
2,227
|
|
Restricted Stock Units
|
598,793
|
|
|
545,422
|
|
|
Lease Termination liability
|
||
Balance at December 31, 2018
|
$
|
509,937
|
|
Charges (included in selling, general and administrative expenses)
|
30,764
|
|
|
Cash payments, net of sublease income
|
(294,351
|
)
|
|
Balance at September 30, 2019
|
$
|
246,350
|
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
|
Other Comprehensive Income
|
|
Total Stockholders' Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balances at June 30, 2019
|
81,046,524
|
|
|
$
|
8,105
|
|
|
$
|
220,770,338
|
|
|
$
|
(117,323,976
|
)
|
|
$
|
—
|
|
|
$
|
103,454,467
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,205,827
|
)
|
|
—
|
|
|
(1,205,827
|
)
|
|||||
Issuance of common stock
|
53,332
|
|
|
5
|
|
|
(5
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Payment of common stock tendered for employee stock-based compensation tax obligations
|
(25,576
|
)
|
|
(3
|
)
|
|
(143,217
|
)
|
|
—
|
|
|
—
|
|
|
(143,220
|
)
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
761,096
|
|
|
—
|
|
|
—
|
|
|
761,096
|
|
|||||
Balances at September 30, 2019
|
81,074,280
|
|
|
$
|
8,107
|
|
|
$
|
221,388,212
|
|
|
$
|
(118,529,803
|
)
|
|
$
|
—
|
|
|
$
|
102,866,516
|
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
|
Other Comprehensive Income
|
|
Total Stockholders' Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balances at December 31, 2018
|
80,763,350
|
|
|
$
|
8,076
|
|
|
$
|
218,697,872
|
|
|
$
|
(115,791,261
|
)
|
|
$
|
—
|
|
|
$
|
102,914,687
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,738,542
|
)
|
|
—
|
|
|
(2,738,542
|
)
|
|||||
Issuance of common stock upon exercise of stock options
|
9,769
|
|
|
1
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock upon vesting of RSUs and exercise of stock-settled appreciation rights
|
121,771
|
|
|
12
|
|
|
(12
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock upon exercise of warrants
|
159,782
|
|
|
16
|
|
|
1,172,785
|
|
|
—
|
|
|
—
|
|
|
1,172,801
|
|
|||||
Issuance of common stock
|
53,332
|
|
|
5
|
|
|
(5
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Payment of common stock tendered for employee stock-based compensation tax obligations
|
(33,724
|
)
|
|
(3
|
)
|
|
(199,807
|
)
|
|
—
|
|
|
—
|
|
|
(199,810
|
)
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
1,717,380
|
|
|
—
|
|
|
—
|
|
|
1,717,380
|
|
|||||
Balances at September 30, 2019
|
81,074,280
|
|
|
$
|
8,107
|
|
|
$
|
221,388,212
|
|
|
$
|
(118,529,803
|
)
|
|
$
|
—
|
|
|
$
|
102,866,516
|
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
|
Other Comprehensive Income
|
|
Total Stockholders' Deficiency
|
|||||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balances at June 30, 2018
|
79,160,058
|
|
|
$
|
7,916
|
|
|
$
|
214,906,962
|
|
|
$
|
(556,232,608
|
)
|
|
$
|
—
|
|
|
$
|
(341,317,730
|
)
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
388,050,413
|
|
|
—
|
|
|
388,050,413
|
|
|||||
Issuance of common stock upon exercise of stock options
|
395,663
|
|
|
39
|
|
|
252,640
|
|
|
—
|
|
|
—
|
|
|
252,679
|
|
|||||
Issuance of common stock upon vesting of RSUs and exercise of stock-settled appreciation rights
|
227,287
|
|
|
23
|
|
|
(23
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock upon exercise of warrants
|
760,625
|
|
|
76
|
|
|
6,007,771
|
|
|
—
|
|
|
—
|
|
|
6,007,847
|
|
|||||
Payment of common stock tendered for employee stock-based compensation tax obligations
|
(223,098
|
)
|
|
(22
|
)
|
|
(1,695,940
|
)
|
|
—
|
|
|
—
|
|
|
(1,695,962
|
)
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
1,176,558
|
|
|
—
|
|
|
—
|
|
|
1,176,558
|
|
|||||
Balances at September 30, 2018
|
80,320,535
|
|
|
$
|
8,032
|
|
|
$
|
220,647,968
|
|
|
$
|
(168,182,195
|
)
|
|
$
|
—
|
|
|
$
|
52,473,805
|
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
|
Other Comprehensive Income
|
|
Total Stockholders' Deficiency
|
|||||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balances at December 31, 2017
|
79,039,000
|
|
|
$
|
7,904
|
|
|
$
|
214,229,581
|
|
|
$
|
(537,375,776
|
)
|
|
$
|
—
|
|
|
$
|
(323,138,291
|
)
|
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
369,416,894
|
|
|
—
|
|
|
369,416,894
|
|
|||||
Issuance of common stock upon exercise of stock options
|
408,698
|
|
|
41
|
|
|
252,638
|
|
|
—
|
|
|
—
|
|
|
252,679
|
|
|||||
Issuance of common stock upon vesting of RSUs and exercise of stock-settled appreciation rights
|
337,084
|
|
|
33
|
|
|
(33
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock upon exercise of warrants
|
760,625
|
|
|
76
|
|
|
6,007,771
|
|
|
—
|
|
|
—
|
|
|
6,007,847
|
|
|||||
Payment of common stock tendered for employee stock-based compensation tax obligations
|
(224,872
|
)
|
|
(22
|
)
|
|
(1,708,268
|
)
|
|
—
|
|
|
—
|
|
|
(1,708,290
|
)
|
|||||
Cumulative effect of accounting change
|
—
|
|
|
—
|
|
|
—
|
|
|
(223,313
|
)
|
|
—
|
|
|
(223,313
|
)
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
1,866,279
|
|
|
—
|
|
|
—
|
|
|
1,866,279
|
|
|||||
Balances at September 30, 2018
|
80,320,535
|
|
|
$
|
8,032
|
|
|
$
|
220,647,968
|
|
|
$
|
(168,182,195
|
)
|
|
$
|
—
|
|
|
$
|
52,473,805
|
|
2019
|
|
$
|
97,538
|
|
2020
|
|
591,108
|
|
|
2021
|
|
600,362
|
|
|
2022
|
|
368,467
|
|
|
2023
|
|
402,078
|
|
|
Thereafter
|
|
1,387,139
|
|
|
Total undiscounted cash flows under leases
|
|
3,446,692
|
|
|
Less: Imputed interest
|
|
(515,980
|
)
|
|
Present value of lease liabilities
|
|
$
|
2,930,712
|
|
2019
|
|
$
|
541,376
|
|
2020
|
|
304,000
|
|
|
2021
|
|
304,000
|
|
|
2022
|
|
320,774
|
|
|
2023
|
|
352,000
|
|
|
Thereafter
|
|
1,197,778
|
|
|
Total
|
|
$
|
3,019,928
|
|
|
|
SIGA TECHNOLOGIES, INC.
|
||
|
|
(Registrant)
|
||
|
|
|
||
Date:
|
November 5, 2019
|
By:
|
/s/ Daniel J. Luckshire
|
|
|
|
|
Daniel J. Luckshire
|
|
|
|
|
Executive Vice President and
|
|
|
|
|
Chief Financial Officer
|
|
|
|
|
(Principal Financial Officer and
|
|
|
|
|
Principal Accounting Officer)
|
Previous edition unusable
|
STANDARD FORM 30 (REV 11/2016)
Prescribed by GSA FAR (48 CFR) 53 243 |
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201800019C/P00003
|
PAGE OF
|
||||||
2
|
5
|
|||||||
NAME OF OFFEROR OR CONTRACTOR
SIGA TECHNOLOGIES, INC. 1385150
|
||||||||
ITEM NO.
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
|||
(A)
|
(B)
|
(C)
|
(D)
|
(E)
|
(F)
|
|||
|
Base Award Amt: $51,641,805.00
Mod 0001 Amt: $12,186,975.00 Mod P00002 Amt: $11,255,170.00 Mod P00003 Amt: $ 2,425,815.00 Revised CX Amt: $77,509,765.00 Period of Performance: 09/10/2018 to 09/09/2028 Change Item 1 to read as follows (amount shown is the obligated amount): |
|
|
|
|
|||
1
|
Base period funds for Procurement and Late-Stage
Development of Smallpox Antiviral Drug(s) |
|
|
|
0.00
|
|||
|
|
|
|
|
|
|||
|
Accounting Info:
2018.199TWNP.26402 Appr. Yr.: 2018 CAN: 199TWNP Object Class: 26402 Funded: $0.00 |
|
|
|
|
|||
|
|
|
|
|
|
|||
|
CLIN 0003 under the Base period is changed with no funding changes as follows:
|
|
|
|
|
|||
|
|
|
|
|
|
|||
|
{Removed from Contract: Post-marketing field study, bioanalytical support for emergency use of TPOXX and post‑marketing field study, TPOXX susceptibility evaluation, pharmacokinetic support for post-marketing field study, PK evaluation in subjects with bodyweight >120 kg, TPOXX-phosphate binders DDI evaluation, environmental impact of TPOXX use, technical transfer to increase manufacturing capacity for surge capacity, stability of existing BDS and FDP batches, and maintenance and support of NDA and electronic IND and NDA submissions for oral formulation.}
|
|
|
|
|
|||
|
|
|
|
|
|
|||
|
{Added to Contract: Procurement of BDS for manufacturing of IV TPOXX}
|
|
|
|
|
|||
|
|
|
|
|
|
|||
|
Change Item 2 to read as follows (amount shown is the obligated amount):
|
|
|
|
|
|||
|
|
|
|
|
|
|||
2
|
ASPR-19-00662 -- Exercise of Option CLIN 0007 to SIGA Technologies Inc. for Phase IV post-marketing commitment studies under contract HHSO100201899919C
|
|
|
|
2,425,815.00
|
|||
|
|
|
|
|
|
|||
|
Accounting Info:
2019.1990051.25505 Appr. Yr.: 2019 CAN: 1990051 Object Class: 25505 Funded: $0.00 |
|
|
|
|
|||
|
|
|
|
|
|
|||
|
Accounting Info:
2019.1990051.25505 Appr. Yr.: 2019 CAN: 1990051 Object Class: 25505 Funded: $2,425,815.00 |
|
|
|
|
|||
|
|
|
|
|
|
|||
|
CLIN 0007 is changed as follows in accordance with attached revised Statement of Work, Appendix D, dated 08/27/2019:
|
|
|
|
|
|||
|
|
|
|
|
|
|||
|
CLIN0007 (Option): {removed from contract: Storage of BDS for manufacturing of IV TPOXX}
Continued ... |
|
|
|
|
NSN 7540-01-152-8067
|
OPTIONAL FORM 336 (4-86)
Sponsored by GSA FAR (48 CFR) 53.110 |
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201800019C/P00003
|
PAGE OF
|
||||||
3
|
5
|
|||||||
NAME OF OFFEROR OR CONTRACTOR
SIGA TECHNOLOGIES, INC. 1385150
|
||||||||
ITEM NO.
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
|||
(A)
|
(B)
|
(C)
|
(D)
|
(E)
|
(F)
|
|||
|
{Added to Contract: Post-marketing field study, bioanalytical support for emergency use of TPOXX and post-marketing field study, TPOXX susceptibility evaluation, pharmacokinetic support for post-marketing field study, PK evaluation in subjects with bodyweight >120 kg, TPOXX-phosphate binders DDI evaluation, stability of existing BDS and FDP batches, pediatric formulation development for subjects <13 kg of weight, and maintenance and support of NDA and electronic IND and NDA submissions for oral formulation.}
|
|
|
|
|
|||
|
-
|
|
|
|
|
|||
|
PSC: AN13 NAICS: 541714 HHS/BARDA COR is David Simon, David.Simon@hhs.gov, (202) 260-1101
|
|
|
|
|
NSN 7540-01-152-8067
|
OPTIONAL FORM 336 (4-86)
Sponsored by GSA FAR (48 CFR) 53.110 |
1.
|
CLIN0001 (Base): Method transfer and validation for incoming analytical testing of BDS, process validation support studies and manufacturing, stability studies, electronic regulatory submissions for IV formulation, and if needed, Phase 3 multiple dose study for IV formulation
|
2.
|
CLIN0002 (Base): Immediate delivery of approximately 23,000 treatment courses of oral formulation
|
3.
|
CLIN0003 (Base): {Removed from Contract: Post-marketing field study, bioanalytical support for emergency use of TPOXX and post-marketing field study, TPOXX susceptibility evaluation, pharmacokinetic support for post-marketing field study, PK evaluation in subjects with bodyweight >120 kg, TPOXX-phosphate binders DDI evaluation, environmental impact of TPOXX use, technical transfer to increase manufacturing capacity for surge capacity, stability of existing BDS and FDP batches, and maintenance and support of NDA and electronic IND and NDA submissions for oral formulation.}
|
4.
|
CLIN0004 (Base): Manufacture/fill/package/stability IV TPOXX
|
5.
|
CLIN0005 (Base): Storage of packaged IV TPOXX in VMI for up to 5 years
|
6.
|
CLIN0006 (Base): Delivery of up to 20,000 treatment courses of IV TPOXX to SNS
|
7.
|
CLIN0007 (Option): {Removed from Contract: Storage of BDS for manufacturing of IV TPOXX}
|
8.
|
CLIN0008 (Option): Post-marketing field study, maintenance and support of NDA and electronic IND and NDA submissions for IV formulation, and relabeling (if needed)
|
9.
|
CLIN0009 (Option): Delivery of up to 363,070 treatment courses of oral TPOXX to SNS
|
10.
|
CLIN0010 (Option): Delivery of up to 363,070 treatment courses of oral TPOXX to SNS
|
11.
|
CLIN0011 (Option): Delivery of up to 363,070 treatment courses of oral TPOXX to SNS
|
12.
|
CLIN0012 (Option): Delivery of up to 363,072 treatment courses of oral TPOXX to SNS
|
13.
|
CLIN0013 (Option): Procurement of BDS for manufacturing of IV TPOXX
|
14.
|
CLIN0014 (Option): Storage of BDS for manufacturing of IV TPOXX
|
15.
|
CLIN0015 (Option): Manufacture/fill/package/stability IV TPOXX
|
16.
|
CLIN0016 (Option): Storage of packaged IV TPOXX in VMI for up to 5 years
|
17.
|
CLIN0017 (Option): Delivery of up to 64,000 treatment courses of IV TPOXX to SNS
|
18.
|
CLIN0018 (Option): Procurement of BDS for manufacturing of IV TPOXX
|
19.
|
CLIN0019 (Option): Storage of BDS for manufacturing of IV TPOXX
|
20.
|
CLIN0020 (Option): Manufacture/fill/package/stability IV TPOXX
|
21.
|
CLIN0021 (Option): Storage of packaged IV TPOXX in VMI for up to 5 years
|
22.
|
CLIN0022 (Option): Delivery of up to 64,000 treatment courses of IV TPOXX to SNS
|
23.
|
CLIN0023 (Option): Procurement of BDS for manufacturing of IV TPOXX
|
24.
|
CLIN0024 (Option): Storage of BDS for manufacturing of IV TPOXX
|
25.
|
CLIN0025 (Option): Manufacture/fill/package/stability IV TPOXX
|
26.
|
CLIN0026 (Option): Storage of packaged IV TPOXX in VMI for up to 5 years
|
27.
|
CLIN0027 (Option): Delivery of up to 64,000 treatment courses of IV TPOXX to SNS
|
28.
|
CLIN0028 (Option): Delivery of up to 50,000 treatment courses of IV TPOXX to SNS
|
1.
|
I have reviewed this quarterly report on Form 10-Q of SIGA Technologies, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: November 5, 2019
|
|
/s/ Phillip L. Gomez, Ph.D.
|
Phillip L. Gomez, Ph.D.
|
Chief Executive Officer
|
1.
|
I have reviewed this quarterly report on Form 10-Q of SIGA Technologies, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: November 5, 2019
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/s/ Daniel J. Luckshire
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Daniel J. Luckshire
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Executive Vice President and
Chief Financial Officer
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(1)
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Phillip L. Gomez, Ph.D.
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Phillip L. Gomez, Ph.D.
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Chief Executive Officer
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November 5, 2019
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(1)
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Daniel J. Luckshire
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Daniel J. Luckshire
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Executive Vice President and Chief Financial Officer
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November 5, 2019
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