Table of Contents

 
UNITED STATES
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, 2018
 
Or
¨
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
(IRS Employer Identification. No.)
incorporation or organization)
 
 
 
31 East 62nd Street
10065
New York, NY
(zip code)
(Address of principal executive offices)
 

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 Website, 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  x No ¨ .
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ¨
 
Accelerated filer x
Non-accelerated filer ¨
 
Smaller reporting company x
 
 
Emerging growth company ¨
                            
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes  ¨ No x .
 
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes  x No ¨ .

As of October 31, 2018, the registrant had outstanding 80,330,779 shares of common stock, par value $.0001, per share
 


Table of Contents

SIGA TECHNOLOGIES, INC.
FORM 10-Q

Table of Contents
 
 
Page No.
 
 
 
 





Table of Contents

PART I - FINANCIAL INFORMATION
Item 1 - Condensed Consolidated Financial Statements  
SIGA TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

 
September 30, 2018
 
December 31, 2017
ASSETS
 
 
 
Current assets
 
 
 
Cash and cash equivalents
$
103,985,265

 
$
19,857,833

Restricted cash, short-term
4,095,369

 
10,701,305

Accounts receivable
1,539,538

 
1,802,107

Inventory
2,908,249

 
2,983,249

Prepaid expenses and other current assets
1,134,925

 
2,019,999

Total current assets
113,663,346

 
37,364,493

 
 
 
 
Property, plant and equipment, net
117,864

 
138,640

Restricted cash, long-term

 
6,542,448

Deferred costs

 
96,592,334

Deferred tax assets, net
27,952,578

 
2,431,963

Goodwill
898,334

 
898,334

Other assets
1,095,199

 
702,167

Total assets
$
143,727,321

 
$
144,670,379

LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIENCY)
 
 
 
Current liabilities
 
 
 
Accounts payable
$
894,792

 
$
1,328,867

Accrued expenses and other current liabilities
4,310,917

 
5,481,579

Total current liabilities
5,205,709

 
6,810,446

Deferred revenue

 
377,641,485

Warrant liability
10,729,818

 
11,466,162

Other liabilities
903,953

 
840,253

Long-term debt
74,414,036

 
71,050,324

Total liabilities
91,253,516

 
467,808,670

     Commitments and contingencies

 

Stockholders’ equity/(deficiency)
 
 
 
Common stock ($.0001 par value, 600,000,000 shares authorized, 80,320,535 and 79,039,000 issued and outstanding at September 30, 2018, and December 31, 2017, respectively)
8,032

 
7,904

Additional paid-in capital
220,647,968

 
214,229,581

Accumulated deficit
(168,182,195
)
 
(537,375,776
)
Total stockholders’ equity/(deficiency)
52,473,805

 
(323,138,291
)
Total liabilities and stockholders’ equity/(deficiency)
$
143,727,321

 
$
144,670,379


The accompanying notes are an integral part of these financial statements.

3

Table of Contents

SIGA TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (UNAUDITED)
 
 
Three months ended September 30,
 
Nine months ended September 30,
 
2018
 
2017
 
2018
 
2017
Revenues
 
 
 
 
 
 
 
Product sales and supportive services
$
468,865,229

 
$

 
$
468,865,229

 
$

Research and development
2,210,095

 
1,390,254

 
6,619,245

 
10,856,601

 Total revenues
471,075,324

 
1,390,254

 
475,484,474

 
10,856,601

 
 
 
 
 
 
 
 
Operating expenses
 
 
 
 
 
 
 
Cost of sales and supportive services
95,166,271

 

 
95,166,271

 

Selling, general and administrative
3,114,678

 
3,093,926

 
9,051,617

 
9,022,039

Research and development
3,723,198

 
2,470,835

 
10,043,205

 
13,899,162

Patent expenses
186,028

 
250,857

 
582,833

 
688,471

Lease termination

 
1,225,421

 

 
1,225,421

Total operating expenses
102,190,175

 
7,041,039

 
114,843,926

 
24,835,093

Operating income (loss)
368,885,149

 
(5,650,785
)
 
360,640,548

 
(13,978,492
)
Loss from change in fair value of warrant liability
(2,328,674
)
 
(295,771
)
 
(5,271,503
)
 
(627,624
)
Interest expense
(3,924,124
)
 
(3,737,175
)
 
(11,516,103
)
 
(10,995,900
)
Other income, net
5,067

 
2,021

 
151,454

 
11,818

Income (loss) before income taxes
362,637,418

 
(9,681,710
)
 
344,004,396

 
(25,590,198
)
Benefit (provision) for income taxes
25,412,995

 
(134,668
)
 
25,412,498

 
(342,563
)
Net and comprehensive income (loss)
$
388,050,413

 
$
(9,816,378
)
 
$
369,416,894

 
$
(25,932,761
)
Basic earnings (loss) per share
$
4.85

 
$
(0.12
)
 
$
4.64

 
$
(0.33
)
Diluted earnings (loss) per share
$
4.71

 
$
(0.12
)
 
$
4.53

 
$
(0.33
)
Weighted average shares outstanding: basic
80,023,044

 
78,908,929

 
79,650,373

 
78,842,611

Weighted average shares outstanding: diluted
82,929,476

 
78,908,929

 
82,744,227

 
78,842,611


The accompanying notes are an integral part of these financial statements.

4

Table of Contents

SIGA TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
 
 
Nine months ended September 30,
 
 
2018
 
2017
Cash flows from operating activities:
 
 
 
 
Net Income (loss)
 
$
369,416,894

 
$
(25,932,761
)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
 
 
 
 
Depreciation and other amortization
 
48,639

 
105,212

Increase in fair value of warrant liability
 
5,271,503

 
627,624

Lease termination
 

 
1,225,421

Stock-based compensation
 
1,866,279

 
773,671

Net realization of deferred revenue and costs due to FDA approval
 
(281,950,853
)
 

Deferred income taxes (benefit) provision
 
(25,520,615
)
 
20,383

Write down of inventory
 

 
536,000

Non-cash interest expense
 
3,363,712

 
3,363,712

Changes in assets and liabilities:
 
 
 
 
Accounts receivable
 
369,872

 
2,542,204

Inventory
 

 
22,690,715

Deferred costs
 

 
(24,091,967
)
Prepaid expenses and other current assets
 
960,074

 
(137,970
)
Other assets
 
(393,032
)
 

Accounts payable, accrued expenses and other current liabilities
 
(1,033,651
)
 
(1,719,229
)
Deferred revenue
 

 
9,963,188

Other liabilities
 
63,700

 
(199,501
)
Net cash provided by (used in) operating activities
 
72,462,522

 
(10,233,298
)
Cash flows from investing activities:
 
 
 
 
Capital expenditures
 
(27,863
)
 
(54,242
)
Net cash (used in) investing activities
 
(27,863
)
 
(54,242
)
Cash flows from financing activities:
 
 
 
 
Net proceeds from exercise of stock options
 
252,679

 
27,497

Buy back of stock options
 

 
(84,000
)
Payment of employee tax obligations for common stock tendered
 
(1,708,290
)
 
(193,052
)
Net cash (used in) financing activities
 
(1,455,611
)
 
(249,555
)
Net increase (decrease) in cash and cash equivalents
 
70,979,048

 
(10,537,095
)
Cash, cash equivalents and restricted cash at the beginning of period
 
37,101,586

 
56,174,046

Cash, cash equivalents and restricted cash at end of period
 
$
108,080,634

 
$
45,636,951

 
 
 
 
 
 
 
 
 
 
Supplemental disclosure of cash flows information:
 
 
 
 
      Conversion of warrants to common stock
 
$
6,007,847

 
$

 
 
 
 
 
The accompanying notes are an integral part of these financial statements

5


SIGA TECHNOLOGIES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Condensed Consolidated Financial Statements
 
The financial statements are presented 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 audited financial statements and notes thereto for the year ended December 31, 2017, included in the 2017 Annual Report on Form 10-K. All terms used but not defined elsewhere herein have the meaning ascribed to them in the Company’s 2017 Annual Report on Form 10-K filed on March 6, 2018. 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 2017 year-end condensed consolidated balance sheet data were 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, 2018 are not necessarily indicative of the results expected for the full year.

Liquidity

The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and contemplate the realization of assets and the satisfaction of liabilities in the normal course of business. On July 13, 2018, the United States Food & Drug Administration ( FDA ) approved the Company’s orally-administered drug TPOXX® ( “oral TPOXX® ) for the treatment of smallpox. There is no difference between the approved product and courses of oral TPOXX® that had been delivered to the U.S. Strategic National Stockpile ( Strategic Stockpile ). As such, in July 2018, the Company received $41 million that previously had been held back under the 2011 U.S. Biomedical Advanced Research and Development Authority ( BARDA ) Contract (see Note 3 ). Additionally, since July 2018, the Company has received: a $50 million payment from BARDA in August 2018 as a result of the exercise of an option (through modification of the 2011 BARDA Contract (defined in Note 3)) relating to FDA approval of 84-month expiry for oral TPOXX®; and $80 million of cash proceeds from the sale of its PRV (defined below). Furthermore, the 2018 BARDA Contract (defined in Note 3), awarded in September 2018, could provide payments of up to $629 million to the Company over the next series of years. Accordingly, management believes, based on currently forecasted operating costs that the Company will continue as a going concern.

Priority Review Voucher

Concurrent with the approval of oral TPOXX®, the FDA granted the Company's request for a Priority Review Voucher ( PRV ). A PRV is a voucher that may be used to obtain an accelerated FDA review of a product candidate. On October 31, the Company sold its PRV for cash consideration of $80.0 million (see Note 14 ).

2. Summary of Significant Accounting Policies

Revenue
All of the Company’s revenue is derived from long-term contracts that span multiple years. The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”).

Adoption of ASC 606 . On January 1, 2018, the Company adopted ASC 606 using the modified retrospective method applied to those contracts that were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historical accounting under ASC 605, Revenue Recognition .

The cumulative impact of adopting ASC 606 as of January 1, 2018 was a decrease to deferred revenue of approximately $1.8 million ; a decrease to deferred costs of approximately $2.1 million ; an increase to receivables of approximately $0.1 million and a net increase to opening accumulated deficit of $0.2 million , net of tax. For the  three and nine months ended September 30, 2018 , the impact to revenues as a result of applying ASC 606 was an increase of approximately $1.0 million and $1.3 million , respectively. 

Performance Obligations . A performance obligation is a promise in a contract to transfer a distinct good or service to the customer, and is the unit of account in ASC 606. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. The Company’s research and development contract for the intravenous (IV) formulation of TPOXX® (“IV TPOXX®”) (see “IV Formulation R&D Contract” in Note 3 ) has a single performance obligation (research and development); individual services within the contract are not separately identifiable

6


from other promises in the contract and, therefore, are not distinct from each other. The Company’s 2011 BARDA Contract has three performance obligations: one relates to the manufacture and delivery of product (and performance of services in connection with the manufacture and delivery of product), and the other two performance obligations relate to research and development in connection with oral TPOXX®.

Contract modifications may occur during the course of performance of our contracts. Contracts are often modified to account for changes in contract specifications or requirements. In most instances, contract modifications are for services that are not distinct, and, therefore, are accounted for as part of the existing contract.

The Company’s performance obligations are satisfied over time as work progresses or at a point in time. Substantially all of the Company’s revenue related to research and development performance obligations is recognized over time, because control transfers continuously to our customers. Typically, revenue is recognized over time using costs incurred to date relative to total estimated costs at completion to measure progress toward satisfying the Company’s performance obligations. Incurred cost represents work performed, which corresponds with, and thereby best depicts, the transfer of control to the customer. Contract costs include labor, material, overhead, and third-party services.

Revenue connected with courses of oral TPOXX® delivered to the Strategic Stockpile and related services, milestones and advance payments (activities in combination that constitute one performance obligation) under the 2011 BARDA Contract has been recognized at a point in time. Revenue associated with this performance obligation was recognized when BARDA obtained control of the asset, which was upon delivery to and acceptance by the customer and at the point in time when the constraint on the consideration was resolved. The consideration, which is variable consideration, was constrained until the FDA approved oral TPOXX® for the treatment of smallpox on July 13, 2018. Prior to FDA approval, consideration had been constrained because the Replacement Obligation (as defined in Note 3) had not been quantified or specified. Following FDA approval, the Replacement Obligation was quantified and deemed to be immaterial since there was no difference between the approved product and the courses of oral TPOXX® that had already been delivered to the Strategic Stockpile.

Contract Estimates . Accounting for long-term contracts and grants involves the use of various techniques to estimate total contract revenue and costs. 

Contract estimates are based on various assumptions to project the outcome of future events that often span multiple years. These assumptions include labor productivity; the complexity of the work to be performed; external factors such as customer behavior and potential regulatory outcomes; and the performance of subcontractors, among other variables.

The nature of the work required to be performed on many of the Company’s performance obligations and the estimation of total revenue and cost at completion is complex, subject to many variables and requires significant judgment. The consideration associated with research and development services is variable as the total amount of services to be performed has not been finalized. The Company estimates variable consideration as the most likely amount to which it expects to be entitled. The Company includes estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur and when any uncertainty associated with variable consideration is resolved. The Company’s estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of our historical and anticipated performance, external factors, trends and all other information (historical, current and forecasted) that is reasonably available to us.

A significant change in one or more of these estimates could affect the profitability of the Company’s contracts. As such, the Company reviews and updates its contract-related estimates regularly. The Company recognizes adjustments in estimated revenues, research and development expenses and cost of sales and supportive services under the cumulative catch-up method. Under this method, the impact of the adjustment on revenues, research and development expenses and cost of sales and supportive services recorded to date on a contract is recognized in the period the adjustment is identified. 

Contract Balances . The timing of revenue recognition, billings and cash collections may result in billed accounts receivable, unbilled receivables (contract assets) and customer advances and deposits (contract liabilities) in the condensed consolidated balance sheet. Generally, amounts are billed as work progresses in accordance with agreed-upon contractual terms either at periodic intervals (monthly) or upon achievement of contractual milestones. Under typical payment terms of fixed price arrangements, the customer pays the Company either performance-based payments or progress payments. For the Company’s cost-type arrangements, the customer generally pays the Company for its actual costs incurred, as well as its allocated overhead and G&A costs. Such payments occur within a short period of time.

Remaining Performance Obligations . Remaining performance obligations represent the transaction price for which work has not been performed and excludes unexercised contract options. As of September 30, 2018 the aggregate amount of

7


transaction price allocated to remaining performance obligations for the 2011 BARDA Contract, 2018 BARDA Contract and the IV Formulation R&D Contract is $60.2 million . The Company expects to recognize revenue over the next five years as the specific timing for satisfying the performance obligations is subjective and outside the Company’s control.

Deferred Revenue  
When the Company receives consideration, or such consideration is unconditionally due, prior to transferring goods or services to the customer under the terms of a sales contract, the Company records deferred revenue, which represents a contract liability. The Company recognizes deferred revenue as net revenues once control of goods and/or services has been transferred to the customer and all revenue recognition criteria have been met and any constraints have been resolved.

Historically, the Company deferred revenue in connection with the manufacture and delivery of oral TPOXX® under the 2011 BARDA Contract. Revenue recognition as of June 30, 2018 was constrained by the possibility of product replacement pursuant to the Replacement Obligation. On July 13, 2018, the FDA approved oral TPOXX® for the treatment of smallpox. As a result of FDA approval, the replacement obligation was quantified and deemed to be immaterial since there was no difference between the approved product and the courses of oral TPOXX® that had already been delivered to the Strategic Stockpile. As such, deferred revenue as of June 30, 2018 associated with the 2011 BARDA Contract was recorded as product sales and supportive services during the three months ended September 30, 2018 .

The following table presents changes in the Company's deferred revenue:
 
 
As of September 30, 2018
Balance at December 31, 2017
 
$
378,896,803

Cumulative effect of accounting change
 
(1,780,050
)
Billings in advance of revenue recognized
 

Revenue recognized
 
(376,432,521
)
Balance at September 30, 2018, included in Accrued expenses and other current liabilities
 
$
684,232


As of December 31, 2017, approximately $1.3 million of deferred revenue was included in Accrued expenses and other current liabilities on the condensed consolidated balance sheet.

Restricted Cash and Cash Equivalents
On January 1, 2018, the Company adopted ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash, a consensus of the FASB’s Emerging Issues Task Force . The new standard requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Entities are required to reconcile such total to amounts on the balance sheet and disclose the nature of the restrictions. Adoption of this guidance impacts the cash flow disclosure for the nine months ended September 30, 2017; cash flows from operating activities, as disclosed herein, is $7.6 million less than the amount disclosed in the 2017 third quarter 10-Q.

A portion of the Company’s cash received under the Loan Agreement is restricted. In accordance with the Loan Agreement, cash placed in a specified reserve account is restricted. Except for $5 million , cash in the reserve account could only be utilized to pay interest on the Term Loan. The aforementioned $5 million was withdrawn from the reserve account on July 12, 2018 upon confirmation that there had been no events of default, and was placed in the Company's cash operating account. See Note 7 for additional information.

The following table reconciles cash, cash equivalents and restricted cash per the condensed consolidated statements of cash flows to the condensed consolidated balance sheet for each respective period:


8


 
 
As of
 
 
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

 
 
 
 
 
 
 
September 30, 2017
 
December 31, 2016
Cash and cash equivalents
 
$
25,798,125

 
$
28,701,824

Restricted cash - short-term
 
10,408,810

 
10,138,890

Restricted cash - long-term
 
9,430,016

 
17,333,332

Cash, cash equivalents and restricted cash
 
$
45,636,951

 
$
56,174,046


Recent Accounting Pronouncements
On January 26, 2017, the FASB issued ASU No. 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment . The guidance removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. All other goodwill impairment guidance will remain largely unchanged. Entities will continue to have the option to perform a qualitative assessment to determine if a quantitative impairment test is necessary. The same one-step impairment test will be applied to goodwill at all reporting units, even those with zero or negative carrying amounts. The revised guidance will be applied prospectively, and is effective for fiscal years beginning after December 15, 2019. The Company believes the adoption of ASU No. 2017-04 will not have a significant impact on its consolidated financial statements.

On February 25, 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) , which relates to the accounting for leasing transactions. This standard requires a lessee to record on the balance sheet the assets and liabilities for the rights and obligations created by leases with lease terms of more than 12 months. In addition, this standard requires both lessees and lessors to disclose certain key information about lease transactions. The Company has elected to adopt the standard using the modified retrospective transition approach with a January 1, 2019 effective date of initial application. Under the modified retrospective transition method, the Company will recognize a cumulative effect adjustment to retained earnings as of the effective date in the period of adoption. Consequently, comparative financial information and disclosures provided for dates and periods before January 1, 2019 will not be updated in the Company’s future filings. While the Company is continuing to evaluate the impact that ASU No. 2016-02 will have on its consolidated financial statements, the Company expects its real estate leases to be capitalized and have a material impact on its consolidated balance sheet.
 
3. Procurement Contracts and Research Agreements

2018 BARDA Contract

On September 10, 2018, the Company entered into a contract with BARDA pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX® to the Strategic Stockpile, and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of IV TPOXX®. Additionally, the contract also includes funding from BARDA for advanced development of the IV formulation of TPOXX®; post-marketing activities for oral TPOXX®; and supportive procurement activities. The contract with BARDA (as amended, modified, or supplemented from time to time, the “2018 BARDA Contract”) contemplates up to approximately $628.7 million of payments, of which approximately $51.7 million of payments are included within the base period of performance of five years and up to approximately $577.0 million of payments are specified as options. BARDA may choose in its sole discretion when, or whether, to exercise any of the options. The period of performance for options is up to ten years and such options could be exercised at any time during the contract term, including during the base period of performance. For the three and nine months ended September 30, 2018, the revenue and expense recognized under the 2018 BARDA Contract was immaterial.

The base period of performance includes payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 20,000 courses of final drug product of IV TPOXX®, of which $3.2 million of payments are to be paid upon the manufacture of bulk drug substance to be used in the manufacture of the final drug product courses of IV TPOXX®; payments of approximately $32.0 million to fund advanced development of IV TPOXX®; and payments of approximately $0.6 million for supportive procurement activities.

9



Options, in total, provide for payments up to approximately $577.0 million (if all options are exercised). There are options for the following activities: payments of up to $450.2 million for the delivery of up to approximately 1,452,300 courses of oral TPOXX® to the Strategic Stockpile; payments of up to $76.8 million for the manufacture of up to 192,000 courses of final drug product of IV TPOXX®, of which up to $30.7 million of payments would be paid upon the manufacture of bulk drug substance to be used in the manufacture of the final drug product courses of IV TPOXX®; payments of up to approximately $44.4 million to fund post-marketing activities for oral and IV TPOXX®; and payments of up to approximately $5.6 million for supportive procurement activities.

The options related to IV TPOXX® are divided into two primary manufacturing steps. There are options related to the manufacture of bulk drug substance (“IV BDS Options”), and there are corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA may choose to exercise any, all, or none of these options in its sole discretion. The 2018 BARDA Contract includes: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 64,000 courses of IV TPOXX®; and three separate IV FDP Options, each providing for 64,000 courses of final drug product of IV TPOXX®. BARDA has the sole discretion on whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to make independent exercise decisions. If BARDA decides to only exercise IV BDS Options, then the Company would receive payments up to $30.7 million ; alternatively, if BARDA decides to exercise both IV BDS Options and IV FDP Options, then the Company would receive payments up to $76.8 million .

2011 BARDA Contract

On May 13, 2011, the Company signed a contract with BARDA pursuant to which SIGA agreed to deliver two million courses of oral TPOXX® to the Strategic Stockpile. The contract with BARDA (as amended, modified, or supplemented from time to time, the “2011 BARDA Contract”) includes a base contract, as modified, (“2011 Base Contract”) as well as options (described below). The 2011 Base Contract specifies approximately $508.7 million of payments, of which $459.8 million has been received by the Company for the manufacture and delivery of 1.7 million courses of oral TPOXX® and up to $48.9 million in total is available for certain development and supportive activities, of which $43.8 million has been received as of September 30, 2018 .

Prior to FDA approval of oral TPOXX®, the Company had a product replacement obligation (the “Replacement Obligation”) in the event that the final version of TPOXX® approved by the FDA was different from any courses of TPOXX® that had been delivered to the Strategic Stockpile. On July 13, 2018, the FDA approved oral TPOXX® for the treatment of smallpox and there is no difference between the approved product and courses in the Strategic Stockpile. For courses of oral TPOXX® that have been physically delivered to the Strategic Stockpile, the Company has a product replacement obligation, at no cost to BARDA, in the event that oral TPOXX® is recalled or deemed to be recalled for any reason.

As of September 30, 2018 , the Company had cumulatively delivered 2.0 million courses of oral TPOXX® to the Strategic Stockpile and received $459.8 million under the 2011 Base Contract in connection with the manufacture and delivery of courses of oral TPOXX®. Such receipts were received in the following manner; a $41.0 million advance payment in 2011 for the completion of certain planning and preparatory activities related to the 2011 Base Contract; a $12.3 million milestone payment in 2012 for the completion of the product labeling strategy for oral TPOXX®; an $8.2 million milestone payment in 2013 for the completion of the commercial validation campaign for oral TPOXX®; a $20.5 million payment in 2016 for submission of documentation to BARDA indicating that data covering the first 100 subjects enrolled in the phase III pivotal safety study had been submitted to and reviewed by a Data Safety and Monitoring Board (“DSMB”) and that such DSMB had recommended continuation of the safety study, as well as submission of the final pivotal rabbit efficacy study report to the FDA; $286.9 million of payments for physical deliveries of oral TPOXX® to the Strategic Stockpile beginning in 2013; a $40.9 million holdback payment in 2018 for the FDA-approved version of oral TPOXX® not being any different from courses of oral TPOXX® that had been delivered to the Strategic Stockpile; and a $50.0 million payment (following an option exercise) for FDA approval of 84-month expiry for oral TPOXX®.

The 2011 BARDA Contract includes options. On July 30, 2018, the 2011 BARDA Contract was modified and BARDA exercised its option relating to FDA approval of aforementioned 84-month expiry for oral TOPXX® for which the Company was paid $50.0 million in August 2018. With the option exercise, the 2011 BARDA Contract was modified so that the 2011 Base Contract increased by $50.0 million . Remaining options, if all were exercised by BARDA, would result in aggregate payments to the Company of $72.7 million , including up to $58.3 million of funding for development and supportive activities such as work on a smallpox prophylaxis indication for TPOXX® and/or $14.4 million of funding for production-related activities related to warm-base manufacturing. BARDA may choose, in its sole discretion not to exercise any or all of the unexercised options. In 2015, BARDA exercised two options related to extending the indication of the drug to the geriatric and pediatric populations. The stated value of those exercises was immaterial.


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The 2011 BARDA Contract expires in September 2020.

As described in Note 2, cash inflows related to delivery of courses under the 2011 BARDA Contract had been recorded as deferred revenue prior to FDA approval of oral TPOXX®, which occurred in the third quarter 2018. The deferral was due to a constraint on the consideration received. During the third quarter 2018, the constraint was satisfied with FDA approval of oral TPOXX®. As such, $375.6 million associated with cash consideration received in prior periods under the 2011 BARDA Contract has been recognized as revenue for the three and nine months ended September 30, 2018 . Separately, as discussed above, $91 million of revenues have been recognized in the third quarter in connection with a $41 million holdback payment (under the 2011 BARDA Contract) and a $50 million payment for achieving 84-month expiry for oral TPOXX ® (under the 2011 BARDA Contract). Direct costs incurred by the Company to fulfill the delivery of courses had also been deferred. As of December 31, 2017, deferred direct costs under the 2011 BARDA Contract were approximately $96.5 million . In connection with the FDA approval of oral TPOXX®, all related deferred costs have been recognized in the condensed consolidated statement of operations during the third quarter of 2018.

Research Agreements and Grants
The Company has an R&D program for IV TPOXX®. This program is funded by a development contract with BARDA (“IV Formulation R&D Contract”). This contract has a period of performance that terminates on December 30, 2020.

Contracts and grants include, among other things, options that may or may not be exercised at BARDA’s discretion. Moreover, contracts and grants contain customary terms and conditions including BARDA’s right to terminate or restructure a contract or grant for convenience at any time. As such, we may not be able to utilize all available funds.

4. Inventory

Due to the deferral of revenue under the 2011 BARDA Contract (see Note 2 for additional information), amounts that would be otherwise recorded as cost of sales for delivered courses had been recorded as deferred costs on the condensed consolidated balance sheet. In the third quarter of 2018, such deferred costs were expensed. Inventory includes costs related to the manufacture of TPOXX®.

Inventory consisted of the following:
 
As of
 
September 30, 2018
 
December 31, 2017
Work in-process
$
1,950,445

 
2,025,445

Finished goods
957,804

 
957,804

Inventory
$
2,908,249

 
2,983,249


For the nine months ended September 30, 2017 , research and development expenses included net inventory-related losses of approximately $536,000 related to a $686,000 inventory write-down, partially offset by credits received from contract manufacturing organizations ( CMOs ”) in connection with the inventory write-down. No such losses were incurred in 2018.

5. Property, Plant and Equipment

Property, plant and equipment consisted of the following: 
 
As of
 
September 30, 2018
 
December 31, 2017
Leasehold improvements
$
2,420,028

 
$
2,420,028

Computer equipment
558,118

 
701,762

Furniture and fixtures
363,588

 
363,588

 
3,341,734

 
3,485,378

Less - accumulated depreciation
(3,223,870
)
 
(3,346,738
)
Property, plant and equipment, net
$
117,864

 
$
138,640


Depreciation and amortization expense on property, plant, and equipment was $14,710 and $29,375 for the three months ended September 30, 2018 and 2017 , respectively, and $48,639 a nd $105,212 for the nine months ended September 30, 2018 and 2017 , respectively.

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6. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:
 
As of
 
September 30, 2018
 
December 31, 2017
Bonus
$
1,284,707

 
$
2,538,340

Deferred revenue-R&D for TPOXX® intravenous formulation
684,232

 
1,255,318

Professional fees
411,290

 
381,980

Vacation
323,651

 
328,588

Other (primarily R&D vendors and CMOs)
1,607,037

 
977,353

Accrued expenses and other current liabilities
$
4,310,917

 
$
5,481,579


7. Financial Instruments

2016 Warrant
On September 2, 2016, in connection with the entry into the Loan Agreement (see Note 8 for additional information), the Company issued a warrant (the Warrant ) to the Lender to purchase a number of shares of the Company’s common stock equal to $4.0 million divided by the lower of (i) $2.29 per share and (ii) the subscription price paid in connection with the 2016 rights offering. The Warrant provides for weighted average anti-dilution protection and is exercisable in whole or in part for ten ( 10 ) years from the date of issuance. The per share subscription price paid was $1.50 in connection with the 2016 rights offering; accordingly, the exercise price of the Warrant was set at $1.50 per share.

The Company accounted for the Warrant in accordance with the authoritative guidance which requires that free-standing derivative financial instruments with certain anti-dilution and cash settlement features be classified as assets or liabilities at the time of the transaction, and recorded at their fair value. Any changes in the fair value of the derivative instruments are reported in earnings or loss as long as the derivative contracts are classified as assets or liabilities. Accordingly, the Company classified the Warrant as a liability and reports the change in fair value in the statement of operations.

On September 2, 2016, the issuance date of the Warrant, the fair value of the liability-classified Warrant was $5.8 million . The Company applied a Monte Carlo Simulation-model to calculate the fair value of the liability-classified Warrant using the following assumptions: risk free interest rate of 1.60% ; no dividend yield; an expected life of 10 years; and a volatility factor of 80% . The Company compared the Monte Carlo simulation model calculation to a Black-Scholes model calculation as of December 31, 2016. These models generated substantially equal fair values for the Warrant. As such, the Company continued to utilize a Black-Scholes model for September 30, 2018 to determine the fair value of the Warrant.

As of September 30, 2018 , the fair value of the Warrant was $10.7 million . The fair value of the liability-classified Warrant was calculated using the following assumptions: risk free interest rate of 3.03% ; no dividend yield; an expected life of 7.9 years; and a volatility factor of 70% .

For the three months ended September 30, 2018 and 2017 , the Company recorded a loss of $2.3 million , and $0.3 million , respectively, as a result of the change in fair value of the liability-classified Warrant. For the nine months ended September 30, 2018 and 2017 , the Company recorded a loss of $5.3 million and $0.6 million , respectively, as a result of the change in fair value of the liability-classified Warrant. In addition, during the three months ended September 30, 2018 approximately $6.0 million of warrants were exercised resulting in the net issuance of approximately 760,000 shares of common stock. As of September 30, 2018 there are approximately 1.7 million shares underlying the Warrants.

8. Debt

On September 2, 2016, the Company entered into a loan and security agreement (as amended from time to time, the “Loan Agreement”) with OCM Strategic Credit SIGTEC Holdings, LLC (“Lender”), pursuant to which the Company received $80.0 million (less fees and other items) on November 16, 2016 having satisfied certain pre-conditions. Such $80.0 million had been placed in an escrow account on September 30, 2016 (the “Escrow Funding Date”). Prior to the Escrow Release Date (November 16, 2016), the Company did not have access to, or any ownership interest in, the escrow account. Until the Escrow Release Date occurred, the Company did not have an obligation to make any payments under the Loan Agreement, no security was granted under the Loan Agreement and no affirmative or negative covenants or events of default were effective under the Loan Agreement.

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Amounts were held in the escrow account until the satisfaction of certain conditions including the closing of the Rights Offering (see Note 7 ) on November 16, 2016. As part of the satisfaction of a litigation claim, funds were released from the escrow account (the date on which such transfer occurred, the “Escrow Release Date”).

The Loan Agreement provides for a first-priority senior secured term loan facility in the aggregate principal amount of $80.0 million (the “Term Loan”), of which (i) $25.0 million was placed in a reserve account (the “Reserve Account”) only to be utilized to pay interest on the Term Loan as it becomes due; (ii) an additional $5.0 million was also placed in the Reserve Account and up to the full amount of such $5.0 million was eligible to be withdrawn after June 30, 2018 upon the satisfaction of certain conditions, provided that any of such amount is required to fund any interest to the extent any interest in excess of the aforementioned $25.0 million is due and owing and any of such $5.0 million remains in the Reserve Account; and (iii) $50.0 million (net of fees and expenses then due and owing to the Lender) was paid as part of the final payment to satisfy a litigation claim. Interest on the Term Loan is at a per annum rate equal to the Adjusted LIBOR rate plus , subject to adjustments as set forth in the Loan Agreement. At September 30, 2018 , the effective interest rate on the Term Loan, which includes interest payments and accretion of unamortized costs and fees, was 19.21% . The Company incurred approximately $3.9 million of interest expense during the three months ended September 30, 2018 , of which $2.8 million was paid from restricted cash and the remaining $1.1 million accreted to the Term Loan balance. For the nine months ended September 30, 2018 , the Company incurred approximately $11.5 million of interest expense, of which $8.1 million was paid from restricted cash and the remaining $3.4 million accreted to the Term Loan balance. On July 12, 2018, upon confirmation that there had been no events of default, $5 million was withdrawn by the Company from the Reserve Account and was placed in the Company's cash operating account. On October 31, 2018, the Loan Agreement was amended to expand the definition of permitted dispositions to include a sale of the PRV. In connection with the amendment, proceeds from the sale of the PRV ( $80 million ) have been placed in a restricted cash account; such restricted account is to be used only for interest and principal payments (other than those in connection with an event of default) on the Term Loan, and the payment of certain fees and expenses related to the PRV sale.

The Term Loan shall mature on the earliest to occur of (i) the four-year anniversary of the Escrow Release Date, and (ii) the acceleration of certain obligations pursuant to the Loan Agreement. At maturity, $80.0 million of principal will be repaid, and an additional $4.0 million will be paid (see below). Prior to maturity, there are no scheduled principal payments.

Through the three and one-half year anniversary of the Escrow Release Date, any prepayment of the Term Loan is subject to a make-whole provision in which interest payments related to the prepaid amount are due (subject to a discount of treasury rate plus 0.50% ).

In connection with the Term Loan, the Company has granted the Lender a lien on and security interest in all of the Company’s right, title and interest in substantially all of the Company’s tangible and intangible assets, including all intellectual property.

The Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants. These covenants, among other things, require a minimum cash balance throughout the term of the Term Loan and the achievement of regulatory milestones by certain dates, and contain certain limitations on the ability of the Company to incur unreimbursed research and development expenditures over a certain threshold, make capital expenditures over a certain threshold, incur indebtedness, dispose of assets outside of the ordinary course of business, make cash distributions and enter into certain merger or consolidation transactions. The minimum cash requirement was $5.0 million until August 27, 2018 ( 45 days after FDA approval of oral TPOXX®), at which point the minimum cash requirement became $20.0 million .

The Loan Agreement includes customary events of default, including, among others: (i) non-payment of amounts due thereunder, (ii) the material inaccuracy of representations or warranties made thereunder, (iii) non-compliance with covenants thereunder, (iv) non-payment of amounts due under, or the acceleration of, other material indebtedness of the Company and (v) bankruptcy or insolvency events. Upon the occurrence and during the continuance of an event of default under the Loan Agreement, the interest rate may increase by 2.00% per annum above the rate of interest otherwise in effect, and the Lenders would be entitled to accelerate the maturity of the Company’s outstanding obligations thereunder.

As of September 30, 2018 , the Company is in compliance with the Loan Agreement covenants.

In connection with the Loan Agreement, the Company incurred $8.2 million of costs (including interest on amounts held in the escrow account between September 30, 2016 and November 15, 2016). Furthermore, an additional $4.0 million will become payable when principal of the Term Loan is repaid. As part of the Company's entry into the Loan Agreement, the Company issued the Warrant (see Note 7 ) with a fair market value of $5.8 million . The fair value of the Warrant, as well as costs related to the Term Loan issuance, were recorded as deductions to the Term Loan balance on the Balance Sheet. These amounts are being amortized on a straight-line basis over the life of the related Term Loan. The Company compared the amortization under the effective interest method with the straight-line basis and determined the results were not materially different. The $4.0 million that will be paid

13


when principal is repaid is being accreted to the Term Loan balance each quarter on a per diem basis. As of September 30, 2018 , the Term Loan balance is $74.4 million .

9. Fair Value of Financial Instruments

The carrying value of cash equivalents, restricted cash, accounts payable and accrued expenses and other current liabilities approximates fair value due to the relatively short maturity of these instruments. Common stock warrants which are classified as a liability are recorded at their fair market value as of each reporting period.

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.

The Company uses model-derived valuations where certain inputs are unobservable to third parties to determine the fair value of certain common stock warrants on a recurring basis and classifies such liability-classified warrants in Level 3. As described in Note 7 , the fair value of the liability-classified warrant was $10.7 million at September 30, 2018 .

At September 30, 2018 , the fair value of the debt was $88.6 million and the carrying value of the debt was $74.4 million . The Company used a discounted cash flow model to estimate the fair value of the debt by applying a discount rate to future payments expected to be made as set forth in the Loan Agreement.  The fair value of the loan was measured using Level 3 inputs.  The discount rate was determined using market participant assumptions.

There were no transfers between levels of the fair value hierarchy for the nine months ended September 30, 2018 . In addition, there were no Level 1 or Level 2 financial instruments as of September 30, 2018 and December 31, 2017.

The following table presents changes in the liability-classified warrant measured at fair value using Level 3 inputs:

 
Fair Value Measurements of Level 3 liability-classified warrant
Warrant liability at December 31, 2017
$
11,466,162

Increase in fair value of warrant liability
5,271,503

Exercise of warrants
(6,007,847
)
Warrant liability at September 30, 2018
$
10,729,818


10. Per Share Data

The Company computes, presents and discloses earnings per share in accordance with the authoritative guidance which specifies the computation, presentation and disclosure requirements for earnings per share of entities with publicly held common stock or potential common stock. 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, except that it also gives effect to all potentially dilutive common shares outstanding during the period.

The following is a reconciliation of the basic and diluted earning (loss) per share computation: 


14


 
Three months ended September 30,
 
Nine months ended September 30,
 
2018
 
2017
 
2018
 
2017
Net income (loss) for basic earnings per share
$
388,050,413

 
$
(9,816,378
)
 
$
369,416,894

 
$
(25,932,761
)
Less: Change in fair value of warrants
(2,328,674
)
 

 
(5,271,503
)
 

Net income (loss), adjusted for change in fair value of warrants for diluted earnings per share
$
390,379,087

 
$
(9,816,378
)
 
$
374,688,397

 
$
(25,932,761
)
Weighted-average shares
80,023,044

 
78,908,929

 
79,650,373

 
78,842,611

Effect of potential common shares
2,906,432

 

 
3,093,854

 

Weighted-average shares: diluted
82,929,476

 
78,908,929

 
82,744,227

 
78,842,611

Earnings (loss) per share: basic
$
4.85

 
$
(0.12
)
 
$
4.64

 
$
(0.33
)
Earnings (loss) per share: diluted
$
4.71

 
$
(0.12
)
 
$
4.53

 
$
(0.33
)

For the three and nine months ended September 30, 2018, the diluted earnings per share calculation reflects the effect of the assumed exercise of outstanding warrants and any corresponding elimination of the impact included in operating results from the change in fair value of the warrants. Diluted shares outstanding include the dilutive effect of in-the-money options and warrants, unvested restricted stock and unreleased restricted stock units. The dilutive effect of warrants and options is calculated based on the average share price for each fiscal period using the treasury stock method. Under the treasury stock method, the amount the employee must pay for exercising stock options, the average amount of compensation cost for future service that the Company has not yet recognized, and the amount of tax benefits that would be recorded in additional paid-in capital when the award becomes deductible, are collectively assumed to be used to repurchase shares.


The Company incurred losses for the three and nine months ended September 30, 2017 and as a result, the equity instruments listed below are excluded from the calculation of diluted earnings (loss) per share as the effect of the exercise, conversion or vesting of such instruments would be anti-dilutive. The weighted average number of equity instruments excluded consists of:
 
Three months ended September 30,
 
Nine months ended September 30,
 
2017
 
2017
Stock Options
1,200,123

 
1,485,466

Stock-Settled Stock Appreciation Rights
360,031

 
360,031

Restricted Stock Units
1,472,001

 
1,371,364

Warrants
2,690,950

 
2,690,950


The appreciation of each stock-settled stock appreciation right was capped at a determined maximum value. As a result, the weighted average number shown in the table above for stock-settled stock appreciation rights reflects the weighted average maximum number of shares that could be issued.
 
11. Commitments and Contingencies

From time to time, we may be involved in a variety of claims, suits, investigations and proceedings arising from the ordinary course of our business, collections claims, breach of contract claims, labor and employment claims, tax and other matters. Although such claims, suits, investigations and proceedings are inherently uncertain and their results cannot be predicted with certainty, we believe that the resolution of such current pending matters, if any, will not have a material adverse effect on our business, consolidated financial position, results of operations or cash flow. Regardless of the outcome, litigation can have an adverse impact on us because of legal costs, diversion of management resources and other factors.

12. Related Party Transactions

Board of Directors and Outside Counsel
A member of the Company’s Board of Directors is a member of the Company’s outside counsel. During the three months ended September 30, 2018 and 2017 , the Company incurred expenses of $115,600 and $82,000 , respectively, related to services provided

15


by the outside counsel. During the nine months ended September 30, 2018 and 2017 , the Company incurred expenses of $335,349 and $298,000 , respectively, related to services provided by the outside counsel. On September 30, 2018 the Company’s outstanding payables and accrued expenses included an approximate $77,800 liability to the outside counsel.

Real Estate Leases
On May 26, 2017 the Company and MacAndrews & Forbes Incorporated (“M&F”) entered into a ten-year Office Lease agreement (the “New HQ Lease”), pursuant to which the Company agreed to lease 3,200 square feet at 27 East 62 nd  Street, New York, New York. The Company is utilizing premises leased under the New HQ Lease as its corporate headquarters. The Company's rental obligations consist of a fixed rent of $25,333 per month in the first sixty-three months of the term, subject to a rent abatement for the first six months of the term. From the first day of the sixty-fourth month of the term through the expiration or earlier termination of the lease, the Company's rental obligations consist of a fixed rent of $29,333 per month. In addition to the fixed rent, the Company will pay a facility fee in consideration of the landlord making available certain ancillary services, commencing on the first anniversary of entry into the lease. The facility fee will be $3,333 per month for the second year of the term and increasing by five percent each year thereafter, to $4,925 per month in the final year of the term.

On July 31, 2017, the Company and M&F entered into a Termination of Sublease Agreement (the “Old HQ Sublease Termination Agreement”), pursuant to which the Company and M&F agreed to terminate the sublease dated January 9, 2013 for 6,676 square feet of rental square footage located at 660 Madison Avenue, Suite 1700, New York, New York (such sublease being the “Old HQ Sublease” and the location being the “Old HQ”). Effectiveness of the Old HQ Sublease Termination Agreement was conditioned upon the commencement of a sublease for the Old HQ between M&F and a new subtenant (the “Replacement M&F Sublease”), which occurred on August 2, 2017. The Old HQ Sublease Termination Agreement obligates the Company to pay, on a monthly basis, an amount equal to the discrepancy (the “Rent Discrepancy”) between the sum of certain operating expenses and taxes (“Additional Rent”) and fixed rent under the overlease between M&F and the landlord at 660 Madison Avenue and the sum of Additional Rent and fixed rent under the Replacement M&F Sublease. Under the Old HQ Sublease Termination Agreement, the Company and M&F release each other from any liability under the Old HQ Sublease. For the time period between August 2, 2017 and August 31, 2020 (the expiration date of the Old HQ Sublease), the Company estimates that it will pay a total of approximately $1.1 million in Rent Discrepancy under the Old HQ Sublease Termination Agreement.

As a result of the above-mentioned transactions, the Company discontinued usage of Old HQ in the third quarter of 2017. As such, during the year ended December 31, 2017 the Company recorded a loss of approximately $1.1 million in accordance with Accounting Standards Codification ( ASC ) 420, Exit or Disposal Obligations . This loss primarily represented the discounted value of estimated Rent Discrepancy payments to occur in the future, and included costs related to the termination of the old HQ Sublease. The Company also wrote-off approximately $0.1 million of leasehold improvements and furniture and fixtures related to the Old HQ.

The following table summarizes activity relating to the liability that was recorded as a result of the lease termination:

 
Lease Termination liability
Balance at December 31, 2017
$
814,622

Charges (included in selling, general and administrative expenses)
14,149

Cash payments, net of sublease income
(239,309
)
Balance at September 30, 2018
$
589,462


As of September 30, 2018 , approximately $0.3 million of the lease termination liability is included in Other liabilities on the Condensed Consolidated Balance sheet with the remainder included in Accrued expenses and other current liabilities.

Pre-Clinical Development Program
On May 17, 2018, the Company and vTv Therapeutics LLC (“vTv”) entered into an asset purchase agreement, pursuant to which the Company acquired data related to certain pre-clinical development activities. Such data contain information that could be used to potentially develop clinical drug candidates. A de minimis amount ($10) was paid by the Company to vTv in order to execute the asset purchase agreement. vTv, which is majority owned by M&F, will receive a royalty of 1-4% of sales in the event that SIGA is able to (i) successfully develop a drug from the acquired data and (ii) there are drug sales. Additionally, vTv will receive up to 10% of development revenues in the event that SIGA receives revenues in connection with any development activities.

13. Income Taxes


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ASC 740, Income Taxes requires that a valuation allowance be established when it is “more likely than not” that all or a portion of deferred tax assets will not be realized. At each reporting date, the Company considers new evidence, both positive and negative, that could impact management’s view with regard to future realization of deferred tax assets. During the quarter ended September 30, 2018, the Company received FDA approval and recorded revenue related to the delivery of its TPOXX® product. The Company also recorded revenue related to the FDA holdback payment and the payment for 84-month expiry. In addition, the Company entered into a new contract with BARDA for the purchase of up to 1.7 million courses of TPOXX®. Based on these factors, the Company determined during the quarter ended September 30, 2018 that sufficient positive evidence exists to conclude that substantially all of its deferred tax assets are realizable on a more-likely-than-not basis.

On December 22, 2017, the SEC staff issued Staff Accounting Bulletin (“SAB”) No. 118, which provides guidance on accounting for the tax effects of the 2017 Tax Cuts and Jobs Act (“TCJA”). The purpose of SAB No. 118 was to address any uncertainty or diversity of view in applying ASC Topic 740, Income Taxes  in the reporting period in which the TCJA was enacted. SAB No. 118 addresses situations where the accounting is incomplete for certain income tax effects of the TCJA upon issuance of a company’s financial statements for the reporting period that includes the enactment date. SAB No. 118 allows for a provisional amount to be recorded if it is a reasonable estimate of the impact of the TCJA. Additionally, SAB No. 118 allows for a measurement period to finalize the effects of the TCJA, not to extend beyond one year from the date of enactment. The Company's accounting for the TCJA is complete as of September 30, 2018 with no significant differences from our provisional estimates.
 
For the three and nine months ended September 30, 2018, we incurred pre-tax income of $362.6 million and $344.0 million and a corresponding income tax benefit of $25.4 million and $25.4 million , respectively, which includes a discrete benefit of $25.8 million for both periods. For the three and nine month period, the $25.8 million benefit primarily relates to the Company’s assessment that its deferred tax assets are realizable on a more-likely-than-not basis as a result of the award of the 2018 BARDA Contract and current forecasts of future pre-tax earnings.

14. Subsequent Events

On October 31, 2018, the Company sold its PRV for cash consideration of $80 million . In connection with the PRV sale, the Loan Agreement was amended to expand the definition of permitted dispositions to include a sale of the PRV. Proceeds from the sale of the PRV ( $80 million ) were placed in a restricted cash account. The restricted account is to be used only for interest and principal payments (other than those in connection with an event of default) on the Term Loan, and the payment of certain fees and expenses related to the PRV sale.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with our condensed consolidated financial statements and notes to those statements and other financial information appearing elsewhere in this Quarterly Report on Form 10-Q. 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
 
We are a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is an oral formulation of TPOXX® (“oral TPOXX®”), an antiviral drug for the treatment of human smallpox disease caused by variola virus.

On July 13, 2018 the United States Food & Drug Administration (“FDA”) approved oral TPOXX® for the treatment of smallpox. Oral TPOXX® is a novel small-molecule drug that has been delivered to the U.S. Strategic National Stockpile (“Strategic Stockpile”) under the Project BioShield Act of 2004 (“Project BioShield”). Concurrent with the approval, FDA granted the Company's request for a Priority Review Voucher (“PRV”). A PRV is a voucher that may be used to obtain an accelerated FDA review of a product candidate. On October 31, 2018, the Company sold its PRV for cash consideration of $80.0 million.

Lead Product-TPOXX®

2018 BARDA Contract

On September 10, 2018, the Company entered into a contract with the U.S. Biomedical Advanced Research and Development Authority (“BARDA”) pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX® to the Strategic Stockpile, and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000

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courses of the intravenous (IV) formulation of TPOXX® (“IV TPOXX®”). Additionally, the contract also includes funding from BARDA for advanced development of the IV TPOXX®; post-marketing activities for oral TPOXX®; and supportive procurement activities. The contract with BARDA (as amended, modified, or supplemented from time to time, the “2018 BARDA Contract”) contemplates up to approximately $628.7 million of payments, of which approximately $51.7 million of payments are included within the base period of performance of five years and up to approximately $577.0 million of payments are specified as options. BARDA may choose in its sole discretion when, or whether, to exercise any of the options. The period of performance for options is up to ten years and such options could be exercised at any time during the contract term, including during the base period of performance.

The base period of performance includes payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 20,000 courses of final drug product of IV TPOXX®, of which $3.2 million of payments are to be paid upon the manufacture of bulk drug substance to be used in the manufacture of the final drug product courses of IV TPOXX®; payments of approximately $32.0 million to fund advanced development of IV TPOXX®; and payments of approximately $0.6 million for supportive procurement activities.

Options, in total, provide for payments up to approximately $577.0 million (if all options are exercised). There are options for the following activities: payments of up to $450.2 million for the delivery of up to approximately 1,452,300 courses of oral TPOXX® to the Strategic Stockpile; payments of up to $76.8 million for the manufacture of up to 192,000 courses of final drug product of IV TPOXX®, of which up to $30.7 million of payments would be paid upon the manufacture of bulk drug substance to be used in the manufacture of the final drug product courses of IV TPOXX®; payments of up to approximately $44.4 million to fund post-marketing activities for oral and IV TPOXX®; and payments of up to approximately $5.6 million for supportive procurement activities.

2 011 BARDA Contract

On May 13, 2011, the Company signed a contract with BARDA pursuant to which SIGA agreed to deliver two million courses of oral TPOXX® to the Strategic Stockpile. The contract with BARDA (as amended, modified, or supplemented from time to time the 2011 “BARDA Contract”) includes a base contract, as modified, (“2011 Base Contract”) as well as options. The 2011 Base Contract specifies approximately $508.7 million of payments, of which $459.8 million has been received by the Company for the manufacture and delivery of 1.7 million courses of oral TPOXX® and up to $48.9 million in total is available for certain reimbursements in connection with development and supportive activities, of which $43.8 million has been received as of September 30, 2018 .

Under the 2011 Base Contract, BARDA agreed to buy from the Company 1.7 million courses of oral TPOXX®. Additionally, the Company agreed to contribute to BARDA 300,000 courses at no additional cost to BARDA. For courses of oral TPOXX® that have been physically delivered to the Strategic Stockpile, the Company has a product replacement obligation, at no cost to BARDA, in the event that oral TPOXX® is recalled or deemed to be recalled for any reason.

Prior to FDA approval of oral TPOXX®, the Company had a product replacement obligation (the “Replacement Obligation”) in the event that the final version of TPOXX® approved by the FDA was different from any courses of TPOXX® that had been delivered to the Strategic Stockpile. On July 13, 2018, the FDA approved oral TPOXX® for the treatment of smallpox and there is no difference between the approved product and courses in the Strategic Stockpile.

In addition, the 2011 BARDA Contract includes options. On July 30, 2018, the 2011 BARDA Contract was modified and BARDA exercised its option relating to FDA approval of 84-month expiry for oral TPOXX® for which the Company was paid $50.0 million in August 2018. With the option exercise, the 2011 BARDA Contract was modified so that the 2011 Base Contract increased by $50.0 million . Remaining options, if all were exercised by BARDA, would result in aggregate payments to the Company of $72.7 million , including up to $58.3 million of funding for development and supportive activities such as work on a smallpox prophylaxis indication for TPOXX® and/or $14.4 million of funding for production-related activities related to warm-base manufacturing. BARDA may choose in its sole discretion not to exercise any or all of the unexercised options. In 2015, BARDA exercised two options related to extending the indication of the drug to the geriatric and pediatric populations. The stated value of those exercises was minimal.

The 2011 BARDA Contract expires in September 2020.

Liquidity


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The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and contemplate the realization of assets and the satisfaction of liabilities in the normal course of business. On July 13, 2018, the FDA approved the Company’s orally-administered drug TPOXX® ( “oral TPOXX® ) for the treatment of smallpox. There is no difference between the approved product and courses of oral TPOXX® that have been delivered to the Strategic Stockpile. Additionally, since July 2018, the Company has received: a $50 million payment from BARDA in August 2018 as a result of the exercise of an option (through modification of the 2011 BARDA Contract (defined in Note 3)) relating to FDA approval of 84-month expiry for oral TPOXX®; and $80 million of cash proceeds from the sale of its PRV (defined in Note 1 ). Furthermore, the 2018 BARDA Contract (defined in Note 3), awarded in September 2018, could provide payments of up to $629 million to the Company over the next series of years. Accordingly, management believes, based on currently forecasted operating costs that the Company will continue as a going concern.

Critical Accounting Estimates
 
The methods, estimates and judgments we use in applying our accounting policies have a significant impact on the results we report in our condensed consolidated financial statements, which we discuss under the heading “Results of Operations” following this section of our Management’s Discussion and Analysis of Financial Condition and Results of Operations. Some of our accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. Information regarding our critical accounting policies and estimates appear in Item 7, Management; Discussion of Analysis and of Financial Condition and Results of Operations of our Annual Report on Form 10-K for the year ended December 31, 2017 as filed on March 6, 2018. During the three months ended September 30, 2018 the only change to our Critical Accounting Policies was with respect to revenue recognition, which is discussed below.

Revenue Recognition
All of our revenue is derived from long-term contracts that can span multiple years. We account for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). The unit of account in ASC 606 is a performance obligation. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. Our performance obligations are satisfied over time as work progresses or at a point in time.

Substantially all of our revenue associated with research and development performance obligations is recognized over time. Because control transfers over time with these performance obligations, revenue is recognized based on the extent of progress towards completion of the performance obligation. The selection of the method to measure progress towards completion requires judgment and is based on the nature of the products or services to be provided. We generally use the cost-to-cost measure of progress for performance obligations connected with research and development activities because it best depicts the transfer of control to the customer, which occurs as we incur costs under our contracts. Under the cost-to-cost measure of progress, the extent of progress towards completion is measured based on the ratio of costs incurred to date to the total estimated costs to fully satisfy the performance obligation. Contract costs include labor, material, overhead and third-party services.

Revenue under the 2011 BARDA Contract (see Note 3 to the condensed consolidated financial statements) connected with courses of oral TPOXX® that are manufactured and delivered to the Strategic Stockpile and related services, milestones and advance payments (activities in combination that constitute one performance obligation) has been recognized at a point in time. Revenue associated with this performance obligation was recognized when BARDA obtained control of the asset, which was upon delivery to and acceptance by the customer and at the point in time when the constraint on the consideration was reasonably resolved. The consideration, which is variable, was constrained until the FDA approved oral TPOXX® for the treatment of smallpox on July 13, 2018. Prior to FDA approval, consideration had been constrained because the Replacement Obligation (as defined herein) had not been quantified or specified. Following FDA approval, the Replacement Obligation has been quantified and deemed to be immaterial since there is no difference between the approved product and the courses of oral TPOXX® that have already been delivered to the Strategic Stockpile. As a result, the deferred revenue associated with the performance obligation was recorded as product sales and supportive services for the three months ended September 30, 2018 .

Due to the nature of the work required to be performed on many of our performance obligations, the estimation of total revenue and costs to satisfy the obligations is complex, subject to many variables and requires significant judgment. The consideration associated with these types of performance obligations is considered variable. We estimate variable consideration as the most likely amount to which we expect to be entitled. We include estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur and when any uncertainty associated with variable consideration is resolved. Our estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of our historical and anticipated performance, external factors, trends and all other information (historical, current and forecasted) that is reasonably available to us.


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Contracts are often modified to account for additional services to be performed. We consider contract modifications to exist when the modification either creates new enforceable rights and obligations, or changes existing enforceable rights and obligations. The effect of a contract modification on the transaction price and our measure of progress for the performance obligation to which it relates, is recognized as an adjustment to revenue (either as an increase in or a reduction of revenue) on a cumulative catch-up basis.

We have a process in which management reviews the progress and execution of our performance obligations. As part of this process, management reviews information including, but not limited to, any outstanding key contract matters, progress towards completion and the related program schedule, identified risks and opportunities and the related changes in estimates of revenues and costs. The risks and opportunities include management’s judgment about the ability and cost to achieve the schedule, technical requirements and other contract requirements. Management must make assumptions and estimates regarding labor productivity, the complexity of the work to be performed, customer behavior and execution by our subcontractors, among other variables.

Based on this analysis, any quarterly adjustments to revenues, research and development expenses and cost of sales and supportive services are recognized as necessary in the period they become known. Changes in estimates of revenues, research and development expenses and cost of sales and supportive services are recognized quarterly on a cumulative catch-up basis, which recognizes in the current period the cumulative effect of the changes on current and prior periods based on a performance obligation’s percentage of completion. A significant change in one or more of these estimates could affect the profitability of one or more of our performance obligations.

Results of Operations
 
Three and nine months ended September 30, 2018 and 2017

Revenues from product sales and supportive services for the three and nine months ended September 30, 2018 were $468.9 million . In 2017, there were no recorded revenues from product sales and supportive services. Such revenues in 2018 are primarily associated with revenue recognition of all cash consideration received in prior periods under the 2011 BARDA Contract that is related to the delivery to the Strategic Stockpile of courses of oral TPOXX® and related services, milestones and advance payments ($375.6 million in total). In prior periods, these receipts had been deferred on the balance sheet since revenue recognition had been constrained by the possibility of a product replacement obligation being applicable. Following FDA approval of oral TPOXX® in the third quarter 2018, the possibility of replacement has been quantified and deemed to be immaterial, thus resulting in the recognition of revenues that previously had been deferred. In addition to the above-mentioned amounts, 2018 product sale revenues also include $91 million received in the third quarter under the 2011 BARDA Contract in connection with a $41 million holdback payment and a $50 million payment for achieving 84-month expiry for oral TPOXX ® (see Note 3 in the financial statements for further detail on these payments).

Revenues from research and development contracts for the three months ended September 30, 2018 and 2017, were $2.2 million and $1.4 million , respectively. The increase in revenue of approximately $0.8 million , or 59% , primarily reflects an increase in revenues from our federal contracts supporting the development of IV TPOXX®, partially offset by the decrease in support of development of oral TPOXX®. Revenues from the federal contract supporting the development of oral TPOXX® have decreased because the number and scale of studies that were active during the three months ended September 30, 2018 have decreased in comparison to the prior year activity. The decrease in activity is attributable to the filing of a new drug application (“NDA”) for oral TPOXX® in December 2017.

Revenues from research and development contracts for the nine months ended September 30, 2018 and 2017 , were $6.6 million and $10.9 million , respectively. The decrease in revenues of approximately $4.2 million , or 39.0% , primarily reflects a decrease in revenues from our federal contract supporting the development of oral TPOXX®, partially offset by an increase in support for the development of IV TPOXX®. Revenues from the federal contract supporting the development of oral TPOXX® have decreased because the number and scale of studies that were active during the nine months ended September 30, 2018 have decreased in comparison to the prior year activity. The decrease in activity is attributable to the filing of the NDA for oral TPOXX® in December 2017.

Cost of sales and supportive services for the three and nine months ended September 30, 2018 , were $95.2 million ; in 2017, there were no recorded cost of sales and supportive services. Following FDA approval on July 13, 2018, all costs incurred in previous periods which had been deferred in connection with the deferral of related revenues have now been recognized in the third quarter 2018.

Selling, General and Administrative (“SG&A”) expenses for the three months ended September 30, 2018 and 2017 , were $3.1 million in both periods. Expense levels have remained consistent over these comparable periods.

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SG&A expenses for the nine months ended September 30, 2018 and 2017 were $9.1 million and $9.0 million , respectively. Non-recurring costs related to the application for listing our stock on The Nasdaq Global Market were largely offset by a reduction in rent expense stemming from the change in corporate headquarters in May 2017.

Research and Development (“R&D”) expenses for the three months ended September 30, 2018 and 2017 were $3.7 million and $2.5 million , respectively, reflecting an increase of approximately $1.3 million , or 50.7% . The increase is attributable to a $1.0 million increase in direct vendor-related expenses supporting the development of IV TPOXX® and higher employee compensation of approximately $0.8 million which is primarily associated with the vesting of restricted stock awards that had been contingent upon the FDA approval of oral TPOXX®. These increases were partially offset by a decrease of approximately $0.4 million in direct vendor-related expenses supporting the development of oral TPOXX® (number and scale of active studies for oral TPOXX® decreased).

R&D expenses for the nine months ended September 30, 2018 and 2017 were $10.0 million and $13.9 million , respectively, reflecting a decrease of approximately $3.9 million , or 27.7% The decrease is attributable to a $4.1 million net decrease in direct vendor-related expenses supporting the development of oral TPOXX® and IV TPOXX®; direct vendor-related expenses related to oral TPOXX® decreased $6.2 million due to a decrease in the number and scale of active studies, whereas such expenses for IV TPOXX® increased $2.1 million. The decrease in R&D expenses is also partially attributable to there being no inventory write-down expenses in 2018; for the nine months ended September 30, 2017 , the Company incurred a net expense of $536,000 in connection with an inventory write-down. These decreases were partially offset by higher employee compensation of approximately $1.2 million which is primarily associated with the vesting of restricted stock awards that had been contingent upon the FDA approval of oral TPOXX®.

Patent expenses for the three and nine months ended September 30, 2018 were $186,028 and $582,833 , respectively. Patent expenses for the three and nine months ended September 30, 2017 were $250,857 and $688,471 , respectively. These expenses reflect our ongoing efforts to protect our lead drug candidates in various geographic territories.

Lease termination expense for the three and nine months ended September 30, 2017 was approximately $1.2 million. This expense relates to the Old HQ Sublease Termination Agreement. See Note 12 to the financial statements for additional information.

Interest expense for the three and nine months ended September 30, 2018 was $3.9 million and $11.5 million , respectively. Interest expense in 2018 represents interest accrued on the Term Loan. The $11.5 million interest expense for the nine months ended September 30, 2018 includes $8.1 million of cash payments from restricted cash and $3.4 million of accretion of unamortized costs and fees related to the Term Loan balance.

Interest expense for the three and nine months ended September 30, 2017 was $3.7 million and $11.0 million , respectively. Interest expense in 2017 represents interest accrued on the Term Loan. The $11.0 million interest expense for the nine months ended September 30, 2017 includes $7.6 million of cash payments from restricted cash, and $3.4 million of accretion of unamortized costs and fees related to the Term Loan balance.
    
Changes in the fair value of liability-classified warrants to acquire common stock were recorded within the income statement. For the three months ended September 30, 2018 and 2017, we recorded a loss of approximately $2.3 million and $0.3 million , respectively, reflecting an increase in the fair value of liability-classified warrants primarily due to the increase in our stock price during these periods. For the nine months ended September 30, 2018 and 2017, we recorded a loss of approximately $5.3 million and $0.6 million , respectively, reflecting an increase in the fair value of liability-classified warrants primarily due to the increase in our stock price during these periods. In addition, during the three months ended September 30, 2018 approximately $6.0 million of warrants were exercised resulting in the issuance of approximately 760,000 shares of common stock.

For the three and nine months ended September 30, 2018, we had pre-tax income of $362.6 million and $344.0 million and a corresponding income tax benefit of $25.4 million and $25.4 million , respectively, which includes a discrete benefit of $25.8 million for both periods. For the three and nine month period, the $25.8 million benefit primarily relates to the Company’s assessment that its deferred tax assets are realizable on a more-likely-than-not basis. The effective tax rate during the three and nine months ended September 30, 2018 was 7.01% and 7.39% , respectively. Our effective tax rate for the period ended September 30, 2018 differs from the statutory rate primarily as a result of the reduction in our valuation allowance.

ASC 740, Income Taxes requires that a valuation allowance be established when it is “more likely than not” that all or a portion of deferred tax assets will not be realized. At each reporting date, we consider new evidence, both positive and negative, that could impact our view with regard to future realization of deferred tax assets. During the quarter ended September 30, 2018,

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we received FDA approval and recorded revenue related to the delivery of our TPOXX® product. We also recorded revenue related to the FDA holdback payment and the payment for 84-month expiry. In addition, we entered into a new contract with BARDA for the purchase of up to 1.7 million courses of TPOXX®. Based on these factors, we determined during the quarter ended September 30, 2018 that sufficient positive evidence exists to conclude that substantially all of our deferred tax assets are realizable on a more-likely-than-not basis. With regard to the deferred asset of $28.0 million as of September 30, 2018, it is anticipated that a substantial portion of the asset will be realized in connection with income generated from the October 31, 2018 PRV sale.

Liquidity and Capital Resources

As of September 30, 2018 , we had $104.0 million in unrestricted cash and cash equivalents compared with $19.9 million at December 31, 2017. As of September 30, 2018 , we had $4.1 million of restricted cash. The restricted cash is utilized to pay interest on the Term Loan as it becomes due.

Operating Activities
Net cash provided by (used in) operations for the nine months ended September 30, 2018 and 2017 was $72.5 million and $(10.2) million , respectively.  For the nine months ended September 30, 2018 , the primary sources of cash inflows were a $41 million holdback payment under the 2011 BARDA Contract (see Note 3 ), and a $50 million payment from BARDA for a modification made to the 2011 BARDA Contract, in which BARDA exercised an option relating to FDA approval of 84-month expiry for oral TPOXX®. These receipts were partially offset by net operating costs and $8.2 million of cash interest expense on the Term Loan. For the  nine months ended September 30, 2017 , we received $8.5 million from BARDA for product delivery, which was more than offset by net operating costs and $4.8 million of payments to contract manufacturing organizations for the manufacture and related support of oral TPOXX®. 

Investing Activities
For the nine months ended September 30, 2018 and 2017 cash usage of approximately $28,000 and $54,000 , respectively, related to capital expenditures.

Financing Activities
Net cash used by financing activities for the nine months ended September 30, 2018 was approximately $1.5 million , which is primarily attributable to the repurchase of $1.7 million of common stock in order to meet minimum statutory tax withholding requirements of stock issued to employees, partially offset by $0.2 million of proceeds received from option exercises. Net cash used by financing activities for the nine months ended September 30, 2017 was approximately $250,000 , which primarily consisted of cash used to repurchase $193,000 of common stock in order to meet minimum statutory tax withholding requirements in respect of restricted shares issued to employees and to buy back $84,000 of options at intrinsic value. Such cash usage was partially offset by $27,000 of proceeds received from option exercises.

Off-Balance Sheet Arrangements
 
The Company does not have any off-balance sheet arrangements, other than its leases.

Recently Issued Accounting Standards

For discussion regarding the impact of accounting standards that were recently issued but not yet effective, on the Company's condensed consolidated financial statements, see Note 2 , Recently Issues Accounting Standards, of Notes to Condensed Consolidated Financial Statements.

Safe Harbor Statement

Certain statements in this Quarterly Report on Form 10-Q, including certain statements contained in “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements relating to the progress of SIGA’s development programs and timelines for bringing products to market and the enforceability of the 2011 BARDA Contract and the 2018 BARDA Contract (collectively, the "BARDA Contracts"). The words or phrases “can be,” “expects,” “may affect,” “may depend,” “believes,” “estimate,” “project” and similar words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the BARDA Contracts, not to exercise a portion, or any, of the options under the those contracts, (ii) the risk that SIGA may not complete performance under the BARDA Contracts on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contracts are modified or canceled at the request or requirement of the U.S. government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to successfully market TPOXX internationally, (v) the risk that potential products, including the IV formulation of TPOXX, or potential alternative uses of TPOXX that appear promising to SIGA or its collaborators,

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cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent seeking or obtaining needed approvals to market these products, (x) the risk that one or more protests could be filed and upheld in whole or in part or other governmental action taken, in either case leading to a delay of performance under the 2018 BARDA Contract or other governmental contracts, (xi) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xii) the risk that changes in domestic and foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xiii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiv) the risk that the U.S. government’s responses (including inaction) to the national and global economic situation may affect SIGA’s business adversely and (xv) the risk that SIGA’s internal controls will not be effective in detecting or preventing a misstatement in SIGA’s financial statements. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.

More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in the presentation, is set forth in SIGA's filings with the Securities and Exchange Commission, including this Quarterly Report on Form 10-Q and SIGA's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, and in other documents that SIGA has filed with the SEC. SIGA urges investors and security holders to read those documents free of charge at the SEC's Web site at http://www.sec.gov . Forward-looking statements are current only as of the date on which such statements were made, and except for our ongoing obligations under the United States of America federal securities laws, we undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events, or otherwise.

Item 3. Quantitative and Qualitative Disclosures About Market Risk
 
Our investment portfolio includes cash and cash equivalents. Our main investment objectives are the preservation of investment capital. We believe that our investment policy is conservative, both in the duration of our investments and the credit quality of the investments we hold. We do not utilize derivative financial instruments, derivative commodity instruments or other market risk sensitive instruments, positions or transactions to manage exposure to interest rate changes. As such, we believe that, the securities we hold are subject to market risk, changes in the financial standing of the issuer of such securities and our interest income is sensitive to changes in the general level of U.S. interest rates. Additionally, we are also subject to the risk of rising LIBOR rates; whenever the minimum rates for one-month, two-month, three-month and six-month LIBOR rates (“minimum LIBOR rate”) are above 1%, then the interest rate charged on the Term Loan could increase materially depending on the magnitude of any increase in LIBOR rates. For every increase of 0.5% in the minimum LIBOR rate (e.g., an increase from a LIBOR rate of 2.50% to 3.00% ), annual interest payments on the Term Loan would increase by approximately $0.4 million . Furthermore, we are subject to the impact of stock price fluctuations of our common stock in that we have a liability-classified warrant in which 1.7 million shares of SIGA common stock can be purchased at a strike price of $1.50 per share. For every $1 increase in the stock price of SIGA, the intrinsic value of the liability-classified warrant will increase by approximately $1.7 million .

Item 4. Controls and Procedures
 
Evaluation of Disclosure Controls and Procedures
 
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2018 . The term “disclosure controls and procedures” is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934. Management recognizes that any disclosure controls and procedures no matter how well designed and operated, can only provide reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
 
Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of September 30, 2018 at a reasonable level of assurance.


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Changes in Internal Control over Financial Reporting
 
There have been no changes in our internal control over financial reporting during the quarter ended September 30, 2018 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 

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PART II-OTHER INFORMATION

Item 1. Legal Proceedings
 
From time to time, we may be involved in a variety of claims, suits, investigations and proceedings arising from the ordinary course of our business, collections claims, breach of contract claims, labor and employment claims, tax and other matters. Although such claims, suits, investigations and proceedings are inherently uncertain and their results cannot be predicted with certainty, we believe that the resolution of such current pending matters, if any, will not have a material adverse effect on our business, condensed consolidated financial position, results of operations or cash flow. Regardless of the outcome, litigation can have an adverse impact on us because of legal costs, diversion of management resources and other factors.

Item 1A. Risk Factors
 
Our results of operations and financial condition are subject to numerous risks and uncertainties described in our 2017 Annual Report on Form 10-K for the fiscal year ended December 31, 2017 . The risk factors contained in that report could materially affect our business, financial position and results of operations. Set forth below are new risk factors or updated risk factors. Otherwise there are no material changes from the risk factors set forth in Part I, Item 1A., “Risk Factors,” of the Company's Annual Report on Form 10-K for the year ended December 31, 2017.

U.S. government contracts require ongoing funding decisions by the government, and the majority of the potential revenue under the 2018 BARDA Contract is tied to options which may or may not be exercised, at the sole discretion of BARDA. Reduced or discontinued BARDA funding could cause our business, financial condition and operating results, our business development efforts or our product development efforts, to suffer materially.

The funding of government programs, which funds BARDA’s purchases under the 2018 BARDA Contract, is subject to Congressional appropriations, generally made on a fiscal year basis even though a program may continue for several years. Our government customers are subject to political considerations and budgetary constraints. Our government customers are also subject to uncertainties as to continued funding of their budgets.

Additionally, government-funded contracts typically consist of a base period of performance and options for the performance of certain future activities. The value of goods and services subject to options may constitute the majority of the total value of the underlying contract, as in the case of the 2018 BARDA Contract.

The 2018 BARDA Contract is primarily option based, with only 8% of contract value committed immediately upon execution of the Contract and 92% of contract value tied to options which are exercisable in the sole discretion of BARDA. There is no guarantee that any options will be exercised, or how many options will be exercised. If some or all of the options under the 2018 BARDA Contract are not exercised, whether because levels of government expenditures and authorizations for biodefense decrease or shift to other programs for any other reason, our business, financial condition and operating results, our business development efforts or our product development efforts may suffer materially.

We expect future operating revenues to come primarily from contracts with BARDA for the provision and maintenance of the U.S. Government’s stockpile of TPOXX®. If BARDA does not enter into additional contracts after the 2018 BARDA Contract to maintain or expand the stockpile of TPOXX®, our business, financial condition and operating results could be materially harmed.

The success of our business and our operating results for the foreseeable future will be substantially dependent on the U.S. government’s commitment to maintaining or expanding its stockpile of TPOXX®, and our entry into contracts to supply or maintain the stockpile. Failure to secure and perform on such contracts could have a material adverse effect on our business, financial condition and operating results. Additionally, the 2018 BARDA Contract does not necessarily increase the likelihood that we will secure future comparable contracts with the U.S. government.

Failure to obtain regulatory approval in international jurisdictions could prevent us from marketing our products abroad.

We may seek to market our products outside the United States. To market our products in the European Union and many other foreign jurisdictions, we may need to obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ from that required to obtain FDA approval.


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The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. We may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or jurisdictions or by the FDA. In addition, failure to obtain approval in one jurisdiction may impact our ability to obtain approval elsewhere. We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products in any non-U.S. market. If we fail to obtain the non-U.S. approvals required to market our product candidates outside the United States or if we fail to comply with applicable non-U.S. regulatory requirements, our target market may be reduced and our ability to realize the full market potential of our product candidates may be harmed and our business, financial condition, results of operations and prospects may be adversely affected.

Because we must obtain regulatory clearance or otherwise operate under strict legal requirements in order to manufacture and market our products in the U.S., we cannot predict whether or when we will be permitted to commercialize our products other than the oral formulation of TPOXX for smallpox antiviral treatment.

While we have received FDA approval for oral TPOXX® for use in smallpox treatment, we have not received FDA approval for the IV formulation of TPOXX® or any additional indications for TPOXX. FDA approval is limited only to those conditions for which a product is demonstrated through clinical trials to be safe and efficacious as set forth in its approved product label. We cannot ensure that the IV formulation of TPOXX® or any other compound developed by us, alone or with others, will prove to be safe and efficacious in pre-clinical or clinical trials or animal efficacy studies, or that oral TPOXX will prove to be safe and efficacious in pre-clinical or clinical trials or animal efficacy studies for additional indications, nor whether all of the applicable regulatory requirements needed to receive full marketing clearance will be met.

Growth of our business may be impacted significantly by our success in completing development and commercialization of drug candidates, or additional indications for TPOXX. If we are unable to commercialize new drug candidates or additional indications, or experience significant delays in doing so, our business may be materially harmed.

We have invested a substantial majority of our efforts and financial resources in the development of our drug candidates. Our ability to generate near-term cash flows is primarily dependent on the success of our smallpox antiviral drug TPOXX®, which has only been approved by the FDA in oral form. The commercial success of our current and future drug candidates, or additional indications for already-approved drugs, will depend on many factors, including:

successful development, formulation and cGMP scale-up of drug manufacturing that meets FDA requirements;

successful development of animal models;

successful completion of non-clinical development, including studies in approved animal models;

our ability to pay the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;

successful completion of clinical trials;

receipt of marketing approvals from FDA for IV TPOXX® and similar foreign regulatory authorities;

establishing arrangements on reasonable terms with suppliers and contract manufacturers;

manufacturing stable commercial supplies of drug candidates, including availability of raw materials;

launching commercial sales of the product, whether alone or in collaboration with others; and

acceptance of the product by potential government customers, public health experts, physicians, patients, healthcare payors and others in the medical community.

We expect to rely on FDA regulations known as the “Animal Rule” to obtain approval for certain of our biodefense drug candidates. The Animal Rule permits the use of animal efficacy studies together with human clinical safety trials to support an application for marketing approval. These regulations are relied upon only occasionally, and both we and the government have limited experience in the application of these rules to the drug candidates that we are developing. It is possible that results from these animal efficacy studies may not be predictive of the actual efficacy of our drug candidates in humans. If we are not successful

26

Table of Contents

in completing the development and commercialization of our drug candidates, whether due to our efforts or due to concerns raised by our governmental regulators or customers, our business would be materially adversely harmed.

We may not be able to fully commercialize the IV formulation of TPOXX®, or receive all potential payments under the 2018 BARDA Contract, if our clinical trials do not demonstrate adequate safety or our animal studies do not demonstrate adequate efficacy.

Before obtaining regulatory approval for the sale of our drug candidates, extensive development is required. The goal of development is to use clinical studies to demonstrate the safety of our drug candidates and animal trials to demonstrate the efficacy of our drug candidates. Clinical trials and animal studies, and related work, are expensive, difficult to design and implement, can take many years to complete and are uncertain as to outcome. Success in pre-clinical testing and early clinical trials does not ensure that later clinical trials or animal efficacy studies will be successful, and interim results of a clinical trial or animal efficacy study do not necessarily predict final results.

A failure of one or more of our clinical trials or animal efficacy studies can occur at any stage of development. We may experience numerous unforeseen events during, or as a result of, pre-clinical testing and the clinical trial or animal efficacy study process that could delay or prevent our ability to receive regulatory approval or commercialize our drug candidates, including:

regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;

we may decide, or regulators may require us, to conduct additional pre-clinical testing or clinical trials, or we may abandon projects that we expect to be promising, if our pre-clinical tests, clinical trials or animal efficacy studies produce negative or inconclusive results;

we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;

regulators or institutional review boards may require that we hold, suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements;

the cost of our clinical trials could escalate and become cost prohibitive;

our governmental regulators may impose requirements on clinical trials, pre-clinical trials or animal efficacy studies that we cannot meet or that may prohibit or limit our ability to perform or complete the necessary testing in order to obtain regulatory approval;

any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable;

we may not be successful in recruiting a sufficient number of qualifying subjects for our clinical trials; or

the effects of our drug candidates may not be the desired effects or may include undesirable side effects or the drug candidates may have other unexpected characteristics.


IV TPOXX® is currently in product development and there can be no assurance of successful commercialization beyond the 2018 BARDA contract.

The fact that the FDA has approved the oral formulation of TPOXX® does not guarantee that our approach to drug development will be effective or will result in the successful commercialization of any other drug, or the IV formulation of TPOXX®. We cannot predict with certainty whether any other drug candidate or expanded indication resulting from our research and development efforts will be approved by the FDA.

All of our potential drug candidates are prone to the risks of failure inherent in pharmaceutical product development, including the possibility that our drug candidates will not or cannot:

be shown to be safe, non-toxic and effective;

otherwise meet applicable regulatory standards;

27

Table of Contents


receive the necessary regulatory approvals;

develop into commercially viable drugs;

be manufactured or produced economically and on a large scale;

be successfully marketed;

be paid for by governmental procurers or be reimbursed by governmental or private insurers; or

achieve customer acceptance.


In addition, third parties may seek to preclude us from marketing our drugs through enforcement of their proprietary or intellectual property rights that we are not aware of, or third parties may succeed in marketing equivalent or superior drug products that do not infringe our IP. Our failure to develop safe, commercially viable future drug candidates would have a material adverse effect on ability to grow our business, impair our financial condition and operations.

If third parties on whom we rely for manufacturing of TPOXX®, and vendor-managed inventory, do not perform as contractually required or as we expect, we may not be able to successfully perform the 2018 BARDA Contract and our business would suffer.

We currently rely on third-party manufacturers and service providers to produce TPOXX®. Under the 2018 BARDA Contract, we are responsible for the performance of these third-party contracts, and our contracts with these third parties give us certain supervisory and quality control rights, but we do not exercise day-to-day control over their activities.

Additionally, we may rely on a third party provider, or multiple providers, to store a portion of the stockpile of IV TPOXX® under the 2018 BARDA Contract, entrusting this vendor with the care and handling of a substantial portion of our inventory of IV TPOXX®. If a third party provider fails to comply with applicable laws and regulations, fails to meet expected deadlines, or otherwise does not carry out its contractual duties to us, or encounters physical damage or natural disaster at its facilities, our ability to meet our IV-related obligations under the 2018 BARDA Contract could be significantly impaired. We do not currently have the internal capacity to perform this important function, and we may not be able to maintain commercial arrangements for these services on reasonable terms.

Our reliance on third parties that we do not control does not relieve us of the responsibilities and requirements imposed by the 2018 BARDA Contract. Third parties may not complete activities on schedule, or may not conduct our trials in accordance with regulatory requirements or our stated protocols. The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of IV TPOXX® or other drug candidates.

We could incur net losses in the future if options are not exercised under the 2018 BARDA Contract.

    While our current cash position is strong, our ability to continue to fund operations will be substantially impacted by cash flows from the 2018 BARDA Contract, which may not be sufficient if BARDA elects, in its sole discretion, not to exercise some or all of the options under the 2018 BARDA Contract. Given the nature of option-based government contracts, we cannot guarantee that we can sustain or enhance our current level of operations. Cash flows could fluctuate significantly and could be delayed from one quarter to another based on several factors. As such, if cash flows from the 2018 BARDA Contract are different from expectations, or if operating expenses or other expenses exceed our expectations or cannot be adjusted accordingly, then our business, results of operations, and financial condition could be materially and adversely affected.

28



Item 2. Unregistered Sale of Equity Securities and Use of Proceeds

On August 9 and September 5, 2018, the Company issued 213,592 and 547,034 shares of its common stock, respectively, to an investor on a net basis upon the partial exercise of a warrant to purchase common stock of the Company. To exercise the warrant, the investor surrendered to the Company 55,503 and 125,704 shares, on August 9th and September 5th respectively, of common stock otherwise issuable under the warrant in order to effect the partial warrant exercise. The exercise price of the warrant was $1.50 per share. Such shares were issued pursuant to the exemption from the registration requirements of the Securities Act provided by Section 4(2) of the Securities Act and/or Regulation D promulgated thereunder, and the issuance did not involve any underwriters, underwriting discounts or commissions, or any public offering. The purchaser is an accredited investor, and the Company issued the shares without any general solicitation or advertisement.


Item 3. Defaults upon Senior Securities

None.

Item 4. Mine Safety Disclosures

No disclosure is required pursuant to this item.

Item 5. Other Information
 
No disclosure is required pursuant to this item.

29



Item 6. Exhibits
Exhibit
No.
 
Description
 
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 
Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 
Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 
Amendment of Solicitation/Modification of Contract 0015, dated July 30, 2018, to Agreement, dated May 13, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA (incorporated by reference to the Current Report on Form 8-K of the Company filed on August 1, 2018).
 
Second Amended and Restated Employment Agreement, dated August 1, 2018, between SIGA Technologies, Inc. and Robin E. Abrams (incorporated by reference to the Current Report on Form 8-K of the Company filed on August 3, 2018).
 
Addendum, dated August 10, 2018 to Seconded Amended and Restated Employment Agreement, dated April 12, 2016, between SIGA Technologies, Inc. and Dennis E. Hruby (incorporated by reference to the Current Report on Form 8-K of the Company filed on August 10, 2018).
 
Contract, dated as of September 10, 2018, between SIGA Technologies, Inc. and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Current Report on Form 8-K of the Company filed on September 11, 2018).
 
Amendment of Solicitation/Modification of Contract 0016, dated September 21, 2018, to Agreement, dated May 13, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA.
 
Amendment of Solicitation/Modification of Contract 0017, dated September 28, 2018, to Agreement, dated May 13, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment).
 
Amendment of Solicitation/Modification of Contract 0018, dated September 28, 2018, to Agreement, dated June 1, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA.

101.INS
 
XBRL Instance Document
101.SCH
 
XBRL Taxonomy Extension Schema
101.CAL
 
XBRL Taxonomy Extension Calculation Linkbase
101.DEF
 
XBRL Taxonomy Extension Definition Linkbase
101.LAB
 
XBRL Taxonomy Extension Label Linkbase
101.PRE
 
XBRL Taxonomy Extension Presentation Linkbase

30


SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 
 
SIGA TECHNOLOGIES, INC.
 
 
(Registrant)
 
 
 
Date:
November 6, 2018
By:
/s/ Daniel J. Luckshire
 
 
 
 
Daniel J. Luckshire
 
 
 
 
Executive Vice President and
 
 
 
Chief Financial Officer
 
 
 
 
(Principal Financial Officer and
 
 
 
Principal Accounting Officer) 

31
Exhibit 10.5

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
1. CONTRACT ID CODE

PAGE OF PAGES
   1 | 2
2 AMENDMENT/MODIFICATION NO .
0016
3. EFFECTIVE DATE
See Block 16C
4. REQUISITION/PURCHASE REQ. NO.
OS227396
5. PROJECT NO. ( If applicable )
6. ISSUED BY CODE
ASPR-BARDA
7. ADMINISTERED BY ( If other than Item 6 ) CODE
ASPR-BARDA02
ASPR-BARDA
200 Independence Ave., S.W.
Room 640-G
Washington DC 20201

ASPR-BARDA
330 Independence Ave, SW, Rm G640
Washington DC 20201
6. NAME AND ADDRESS OF CONTRACTOR ( No., street, county, State and ZIP Code )
(x)
9A. AMENDMENT OF SOLICITATION NO.
SIGA TECHNOLOGIES, INC. 1385150
 
 
SIGA TECHNOLOGIES, INC. 35 E 6
35 E 62ND ST
 
9B. DATED ( SEE ITEM 11 )
NEW YORK NY 100658014
x
10A. MODIFICATION OF CONTRACT/ORDER NO.
HHS0100201100001C
 
 
10B. DATED ( SEE ITEM 13 )
Code     1385150
FACILITY CODE
 
05/13/2011
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIATIONS
   The above numbered solicitation is amended as set forth in item 14. The hour and date specified for receipt of Offers is extended. is not extended.
   Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By
separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT
THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by
virtue of this amendment you desire to change an offer already submitted , such change may be made by telegram or letter, provided each telegram or letter makes
reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
12. ACCOUNTING AND APPROPRIATION DATA ( If required }
See Schedule
13. THIS ITEM ONLY APLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
CHECK ONE
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO ( Specify authority ) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT
 
   ORDER NO. IN ITEM 10A.
 
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES ( such as changes In paying office,
appropriation date, etc
.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
X

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
FAR 52.243-2 Changes - Cost Reimbursement and FAR 1.605-1 - Mutual Agreement of the Parties
 
D. OTHER ( Specify type of modification and authority )
E. IMPORTANT: Contractor is not is required to sign this document and return              1     copies to the issuing office.
14. DESCRIPTION OF AMENDMENT/MODIFICATION ( Organized by UCF section headings, including solicitation/contract subject matter where feasible .)
Tax ID Number: 13-3864870
DUNS Number: 932651516
PURPOSE: This modification is to adjust funding under CLIN 0006 and update designated
COR and Alternate COR.

FUNDS ALLOTED PRIOR TO MOD #16 $522,320,688.00
FUNDS REMOVED WITH MOD #16 - $230,902.00
FUNDS ALLOTTED WITH MOD #16 + $230,902.00
TOTAL FUNDS ALLOTED TO DATE $522,320,688.00 (Unchanged)
EXPIRATION DATE: September 24, 2020 (Unchanged)
CONTRACT FUNDED THROUGH September 24, 2020 (Unchanged)
Continued ...
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
15A. NAME AND TITLE OF SIGNER ( Type or print )

Dennis E. Hruby, CSO

 
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
ELIZABETH STEINER
15B. CONTRACTOR/OFFEROR

BY /s/ Dennis E. Hruby
(Signature of person authorized to sign.)
15C. DATE SIGNED

20 Sep 2018
16B. UNITED STATES OF AMERICA

BY /s/ Elizabeth Steiner
(Signature of the Contracting Officer.)
16C. DATE SIGNED

9/21/18
NSN 7540-01-152-8070     STANDARD FORM 30 (REV. 10-83)
Previous edition unusable     Prescribed by GSA
    FAR (48 CFR) 53.243




CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100001C/0016
PAGE OF
2 | 2
NAME OF OFFEROR OR CONTRACTOR
SIGA TECHNOLOGIES, INC. 1385150

ITEM NO.  
(A)
SUPPLIES/SERVICES  
(B)
QUANTITY  
(C)
UNIT  
(D)
UNIT PRICE  
(E)
AMOUNT  
(F)
 
1) The following revision is made to CLIN 0006 under this modification:

CLIN 0006 is being deobligated in full and then re obligated in full. The amount of
decrease ($230,902) and then increase ($230,902). The total value of this FFP CLIN
is $230,902.00.

2) Update SECTION G, Article G.2. as follows and replace the designated primary COR:

ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following Contracting Officer's Representative (COR) will represent the
Government for the purpose of this contract:

Claiborne Hughes Primary COR
Chia-Wei Tsai, PhD Alternate COR

As delegated by the Contracting Officer, the COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) assisting the contracting Officer in interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

All other terms and conditions of contract HHSO100201100001C remain unchanged.
FOB: Destination
Period of Performance: 06/28/2016 to 09/24/2020

Change Item 1 to read as follows(amount shown is the obligated amount):


Smallpox Antiviral Drug for the Strategic 0.00
National Stockpile CAN 1990001

Accounting Info:
2011.1990001.26402 Appr. Yr.: 2011 CAN: 1990001 Object Class: 26402
Funded: -$230,902.00

Accounting Info:
2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103
Funded: $0.00

Accounting Info:
2018.199TWNP.26201 Appr. Yr.: 2018 CAN: 199TWNP Object Class: 26201
Funded: $230,902.00
 
 
 
 
NSN 7540-01-152-8067    OPTIONAL FORM 336 (4-86)    Sponsored by GSA
    FAR (48 CFR) 53.110


Exhibit 10.6

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
1. CONTRACT ID CODE

PAGE OF PAGES
   1          15
2. AMENDMENT/MODIFICATION NO
0017
3. EFFECTIVE DATE
See Block 16C
4. REQUISITION/PURCHASE REQ NO
5. PROJECT NO. (if applicable.) ,  
6. ISSUED BY CODE
ASPR - BARDA
200 Independence Ave., S.W.
Room 640-G
Washington DC 20201
ASPR - BARDA
7 ADMINISTERED BY (if other than Item 6) CODE
ASPR-BARDA
330 Independence Ave, SW, Rm G640
Washington DC 20201
ASPR-BARDA02
 
 
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
SIGA TECHNOLOGIES, INC. 1385150
SIGA TECHNOLOGIES, INC. 35 E 6
35 E 62ND ST
NEW YORK NY 100658014
(x)
9A. AMENDMENT OF SOLICITATION NO
9B. DATED (SEE ITEM 11)
x
10A. MODIFICATION OF CONTRACT/ORDER NO.
HHSO100201100001C
10B. DATED (SEE ITEM 13)

05/13/2011
CODE     1385150
FACILITY CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
The above numbered solicitation is amended as set forth In Item 14. The hour and data specified for receipt of Offers is extended. is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing Items 8 and 15, and returning ___ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF•YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.


12. ACCOUNTING AND APPROPRIATION DATA (If required.)    Net Decrease:          -$3,837,909.85
See Schedule
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
CHECK ONE
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO : (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
 
B. THE ABOVE NUM8ERBD CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.)  SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
X
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
FAR 52.243-2; Changes – Cost Reimbursement and FAR 1.605-1 - Mutual Agreement of the Parties
 
D. OTHER (Specify type of modification and authority.)
E. IMPORTANT: Contractor  is not. X  is required to sign this document and return ___1___ copies to the issuing office.
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
Tax ID Number: 13-3864870
DONS Number: 932651516
PURPOSE: This modification is to remove expiring funds and to update the Statement of Work Objectives and Section J Attachment 13.

FUNDS ALLOTED PRIOR TO MOD #17 $522,320,688.00
FUNDS REMOVED WITH MOD #17 - $3,837,909.85
TOTAL FUNDS ALLOTED TO DATE $518,482,778.15 (Changed)

EXPIRATION DATE: September 24, 2020 (Unchanged)
CONTRACT FUNDED THROUGH September 24, 2020 (Unchanged)
Continued . . .

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
15A. NAME AND TITLE OF SIGNER (Type or print.)
Phillip L. Gomez, III CEO
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print.)
ELIZABETH STEINER
15B. CONTRACTOR/OFFEROR
/s/ Phillip L. Gomez, III
(Signature of person authorized to sign.)
15C. DATE SIGNED

28 Sep 2018
16B. UNITED STATES OF AMERICA
/s/ Elizabeth Steiner
(Signature of contracting officer.
16. DATE SIGNED

9/28/18



NSN 754041. 152-8070        STANDARD FORM 30 (REV. 1043.3)
Previous edition unusable        Prescribed by GSA
FAR (48 CFR) 53 243

Exhibit 10.6


CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100001C/0017
PAGE OF PAGES
   2 15
NAME OF OFFEROR OR CONTRACTOR
  SIGA TECHNOLOGIES, INC. 1385150
ITEM NO.
(A)
SUPPLIES/SERVICES
(B)
QUANTITY
(C)
UNIT
(D)
UNIT PRICE
(E)
AMOUNT
(F)
 
1) The following revision is made to CLINs 1-5, 7-9 & 0017 and also CLIN 0007 Mod 2 under this modification:
 
All remaining funds in CLINs 1-5, 7-9 & 0017 and also CLIN 0007 Mod 2 are being deobligated in full due to the funds expiring. The amount of decrease for CLINs 1-9 & 0017 is $3,048,548.21 and the amount of decrease for CLIN 0007 Mod 2 is $789,361.64.
 
This change reduces the overall contract value from Not to Exceed $522,320,688.00 to Not to Exceed $518,482,778.15, a decrease of $3,837,909.85 (overall contract value).
 
 
 
 
 
 
 
2) Section C – Statement of Objectives (SOO) and Section J attachment 13 are replaced in full.
 
 
 
 
 
All other terms and conditions of contract HHSO100201100001C remain unchanged.
FOB: Destination
Period of Performance: 06/28/2016 to 09/24/2020
 
Change Item 1 to read as follows (amount shown is the obligated amount):
 
 
 
 
 
1
Smallpox Antiviral Drug for the Strategic National Stockpile CAN 1990001
 
 
-3,048,548.21
 
Delivery: 05/13/2011
Delivery Location Code: OS-BARDA-SWITZER
OS-BARDA-SWITZER
330 Independence Ave, SW, Rm G644
Washington DC 20201 US
Amount: $429,606,374.79
Accounting Info:
2011.199001.26402 Appr. Yr.: 2011 CAN: 1990001 Object Class: 26402
Funded: -$3,048,548.21
 
 
 
 
 
 
Delivery Location Code: HHS/OS/ASPR
HHS/OS/ASPR
200 C St SW
Washington DC 20201 US
Amount: $2,082,082.00
Accounting Info:
2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103
Funded: $0.00
 
Delivery Location Code: HHS/OS/ASPR
HHS/OS/ASPR
200 C St SW
Washington DC 20201 US
Amount: $230,902.00
Accounting Info:
2018.199TWNP.26201 Appr. Yr.: 2018 CAN: 199 TWNP Object Class: 26201
Funded: $0.00
 
Change Item 2 to read as follows (amount shown is the obligated amount):
Continued . . .
 
 



 
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100023C/0018
PAGE OF PAGES
   3 15
 
NAME OF OFFEROR OR CONTRACTOR
SIGA TECHNOLOGIES, INC. 1385150

 
ITEM NO.
(A)
SUPPLIES/SERVICES
(B)
QUANTITY
(C)
UNIT
(D)
UNIT PRICE
(E)
AMOUNT
(F)
2
ST-246 Smallpox Antiviral Expanded Utility and Additional Indications

 
 
 
-789,361.64
 
Delivery: 08/15/2011
Delivery Location Code: OS-BARDA-SWITZER
OS-BARDA-SWITZER
330 Independence Ave, SW, Rm G644
Washington DC 20201 US
Amount: $1,792,033.36
Accounting Info:
2011.1992002.25106 Appr. Yr.: 2011 CAN: 1992002 Object Class: 25106
Funded: -$789,361.64



Section C. Statement Of Objectives (SOO)
C.1.      General Objectives
Independently, and not as an agent of the USG, the Contractor shall furnish all the necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation and travel not otherwise provided by the USG as required to fulfill the programmatic objectives.
C.1.1.
The Contractor shall provide 1,700,000 courses of a smallpox antiviral drug for the treatment of individuals who are symptomatic and/or diagnosed with smallpox disease. The antiviral shall be delivered to the CDC/SNS within the anticipated period of performance of the base contract (5 years). At the government’s sole discretion the base year period may be extended, during performance, pursuant to the additional time parameters set forth in the Project Bio Shield Act of 2004.
C.1.1.1
The Contractor has agreed to provide BARDA with 300,000 additional courses above the 1,700,000 course of smallpox antiviral drug as more fully described in C.1.1. at no additional cost. (CLIN 0022)
C.1.2.
The Contractor shall provide a highly cost-effective, orally available smallpox antiviral drug. The FDP shall be packaged in unit-of-use bottles or other approved packaging to provide for the most cost-effective product life-cycle value and performance, and to allow for ease of distribution and use during a declared emergency.
C.1.3.
The smallpox antiviral drug shall require a maximum treatment course of 3 doses per day administered for up to 21 days and shall have an expiry period of no less than 60 months (from date of manufacture), with a minimum of 56 months remaining when delivered to the CDC/SNS. (CLIN 0012)
C.1.4.
C.1.4. The smallpox antiviral drug shall be developed for potential pre-approval use during a declared emergency under an EUA and ultimate approval by the U.S. Food and Drug Administration (FDA). Please consult http://www.fda.gov/oc/guidance/emergencyuse.html for information concerning EUA. The information and data needed to support this potential use will be determined by the FDA. The Contractor should note that the submission to support potential use under an EUA will be submitted by the CDC/SNS, and the Contractor shall be obligated to supply the CDC/SNS with the data needed to support such a submission, including a right of reference to the Contractor’s Investigational New Drug (IND) application that contains the supporting data.
C.1.5.
The initial approved label indication shall be for treatment of smallpox disease for symptomatic adults (18-64 years general population).

NSN 7540-01-152-8067        OPTIONAL FORM 336 (4-86)
Sponsored by GSA
FAR (48 CFR) 53.110

Exhibit 10.6

C.2.      Chemistry, Manufacturing, Control (CMC) Objectives
C.2.1.
The Contractor shall deliver 1,700,000 treatment courses of FDP, manufactured using a validated process in accordance with cGMP, to the CDC/SNS. The Contractor shall validate critical assays required for Bulk Drug Substance (BDS) and Final Drug Product (FDP) release and stability testing. The FDP shall fulfill the requirements as determined by the FDA for the potential use of the antiviral drug during a declared emergency under an EUA. The antiviral drug shall also be approved in accordance with FDA regulations for the treatment of symptomatic adults.
C.2.2.
The Contractor shall facilitate cGMP site visits or inspections, as recommended by FDA, at the time of production of FDP lots destined for the CDC/SNS, should the FDA determine that this is warranted. In addition, the Contractor shall facilitate site visits or audits deemed necessary by BARDA.
C.2.3.
The Contractor shall develop a stability testing plan in consultation with FDA, CDC/SNS, and BARDA, for IND and FDA-approved product delivered to the CDC/SNS. The plan shall maximize the useable life of the smallpox antiviral product through periodic stability testing. The Contractor shall validate critical assays required for Bulk Drug Substance (BDS) and FDP release and stability testing. The Contractor shall also conduct stability studies on the BDS (stored by Contractor) and FDP lots placed in the CDC/SNS in conformance with FDA requirements throughout the contract lifetime. Testing shall be performed in accordance with current regulatory guidelines to support expiry dating of no less than 60 months (from date of manufacture), with options available to extend expiry dating to 84 months.
C.2.4.
The Contractor shall develop a labeling strategy in consultation with FDA, CDC/SNS, and BARDA to allow for ease of transition from IND to approved product. The labeling strategy shall be submitted to FDA, CDC/SNS, and the BARDA COTR far enough in advance of labeled product being delivered to the CDC/SNS to allow for a complete review and concurrence by CDC/SNS and FDA. For additional information, the Contractor may consult the FDA labeling regulations as outlined in 21 CFR 610.68.
C.2.5.
The Contractor shall develop and implement a plan to extend the age range for which the antiviral drug is indicated, which shall include the treatment of pediatric populations. The Contractor shall develop a concept plan and commence initial development in support of a therapeutic indication in the pediatric population. Statement of Work acceptance is due within six (6) months of award. Work is subject to Contract Officer Authorization (COA). (CLIN 0017 and 0007)
C.3.      Reserved

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.




C.4.      Regulatory, Non-Clinical, and Clinical Objectives
C.4.1.
The Contractor shall submit evidence of an effective Quality Management System (QMS). The Contractor shall ensure that the QMS incorporate all aspects of the proposal to fulfill the project objectives of the contract.
C.4.2.
The Contractor shall develop, submit, and execute non-clinical and clinical study protocols, as determined by FDA, to support the potential use of the product in adults during a declared emergency under an EUA. FDA’s current thinking is presented in the Draft Guidance for Industry, Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention, Docket No. 2007D-0439.
C.4.3.
The Contractor shall inform BARDA of all communications with the FDA. The Contractor shall include the BARDA COTR and subject matter experts as observers, in all scheduled phone calls or face-to-face meetings with the FDA.
C.4.4.
Sufficient non-clinical and clinical study data shall be presented to support the use of the product per its intended label indication and in accordance with FDA guidance. The Contractor shall carry out an assessment of bioavailability in animals and humans.
C.4.4.1
The Contractor shall look to the FDA for assistance in the identification of parameters for validation of critical assays to support an EUA and subsequent approval of the product. In addition to studies performed in accordance with FDA guidance, the Contractor should include plans for or results from completed Phase II studies under an IND to evaluate the safety and pharmacokinetics of the smallpox antiviral drug, Plans for or results from completed therapeutic intervention studies in a post-challenge NHP model following lethal dose (5 x 10 7 pfu via intravenous challenge) of monkeypox virus, and data to support efficacy against variola virus challenge in NHPs as required for therapeutic indication.
C.4.4.2
Contractor should identify contingency studies that may be required to fulfill FDA requirements. The Contractor will evaluate product efficacy in any additional orthopox/NHP model that will provide further information in support of approval from the FDA.
C.4.4.3
The Contractor shall develop, submit, and execute non-clinical plans to demonstrate efficacy under the Animal Efficacy Rule and human safety and pharmacokinetic studies adequate to support FDA approval. The FDA has published “Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible” [21 CFR 601 Subpart H, as well as 21 CFR 314 Subpart I for New Drugs]. This rule, known simply as the “Animal Rule,” was designed to permit approval or licensing of drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions caused by exposure to biological, chemical,

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.




radiological, or nuclear substances. This rule amends the new drug and biological product regulations to identify the information needed to provide substantial evidence of the efficacy of new drug and biological products when human efficacy studies are not ethical and field trials are not feasible. The new rule does not address the need for human safety and pharmacokinetic data, which still must be established. When the Contractor develops plans for studies under the Animal Rule, the plans and studies shall be designed in consultation with appropriate USG agencies, and the data from these studies should support FDA approval of the antiviral product, as well as the potential use of the product in adults during a declared emergency under EUA. Approval will initially be sought for therapeutic treatment of symptomatic adults, followed by contract options for potential label extensions and new formulations for expanded clinical usage. Further, these plans shall include studies to demonstrate safety and efficacy of an optimized dosing regimen, based on supporting data to justify such usage.
C.4.5.
In addition, as mandated under the Animal Rule, the Contractor shall develop a Phase 4 post-marketing plan to continue monitoring usage of the antiviral drug to collect information about its effects in various populations and any side effects associated with its actual use. This “post-marketing plan” shall describe, in general terms, the method of collection of human safety and efficacy data when the product is used in the event of a declared emergency. The Phase 4 post-marketing plan may be revised in consultation with BARDA, FDA, and CDC/SNS post-contract award. (CLIN 0005)
C.4.6.
The Contractor shall create a Target Product Profile (TPP) that will be further defined through discussion and negotiation with the COTR and updated periodically as development proceeds. See “Guidance for Industry and Review Staff: Target Product Profile-A Strategic Development Process Tool”, CDER, March 2007 at www.fda.gov/cder/guidance/6910dft.htm.
C.5.      Shipment, Storage, and Disposition Objectives
C.5.1.
The Contractor shall develop a plan that ensures product will be stored and shipped in compliance with cGMP. Plans should include appropriate shipping validation plans and studies and should include appropriate temperature monitoring during shipment. Particular attention should be placed on determining which, if any, USG and/or foreign country permits/documents will be required for shipment of product to the CDC/SNS. The USG will assume responsibility for long-term storage and emergency distribution of finished product once product is delivered to the CDC/SNS.
C.5.2.
The Contractor shall develop a quality control/quality assurance monitoring plan that shall ensure appropriate storage conditions of the product until it is approved. The Contractor shall be required to enter into a Quality Agreement with the CDC/

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.




SNS after contract award. In addition, this Quality Agreement shall outline the responsibilities of both the Contractor and the USG (i.e., CDC/SNS-Quality Control and BARDA) for product shipping, receiving, and storage. These documents shall be drafted and signed by all parties prior to the transport and storage of the product.
C.5.3.
The Contractor shall develop a delivery schedule that meets the objectives of this Contract. The Contractor shall propose an optimum product delivery schedule that maximizes the level of product in the CDC/SNS over the duration of the contract. The Contractor may be required to store FDP at an appropriate cGMP compliant facility until release testing is complete. The Contractor shall propose a delivery schedule that may not exceed 1 delivery per month. Thirty (30) days of advance notice and Contracting Officers Authorization is required prior to shipment to the CDC/SNS. In the event of a public health emergency, the Contracting Officer may waive (in writing) the requirement of only 1 delivery per month and (30) days of advance notice.
C.5.4.
At the discretion of the USG and independent of quality testing conducted by the Contractor, the USG reserves the right to conduct inspections and collect samples of product held by the Contractor and in the CDC/SNS.
C.5.5.
The USG may exercise an optional CLIN to continue activities to extend the age range for which the antiviral drug is indicated and to include the treatment of pediatric populations. (CLIN 0021)
C.5.6.
The Contractor shall develop a concept plan to conduct studies to extend the range of ages for which the approved antiviral drug is indicated. If the options are exercised, the Contractor shall implement the proposed plan to seek extension of the indicated age range.
C.5.7.
The Contractor shall develop a concept plan to conduct studies to include a therapeutic indication in the geriatric population. If the option is exercised, the Contractor shall implement the proposed plan to include a therapeutic indication in the geriatric population. (CLIN 0018)
C.5.8.
Upon expiration or termination (including partial termination) of this contract, the USG may effect final distribution of any smallpox antiviral remaining in storage at the Contractor’s facility or at the SNS. The Contractor shall implement disposition of the product ONLY after receiving a COA letter from the contracting officer.
C.6.      Project Management & Risk Mitigation Objectives
C.6.1.
Integrated Master Plan

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.




C.6.1.1
The Contractor shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicate the critical path to support an EUA and product approval. Attention should be placed on the amount of time that will be needed by the USG (BARDA, FDA, and CDC) for review of critical documentation. The Contractor shall integrate to demonstrate interdependencies among all CLINS. The Integrated Master Project Plan shall be incorporated into the contract, and will be used to monitor performance of the contract.
C.6.1.2
Critical Path Milestones
C.6.1.2.1
The Integrated Master Project Plan shall outline key, critical path milestones, with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project). The project plan should include, but not be limited to, milestones in manufacturing, non-clinical and clinical studies, regulatory submissions, and delivery of product to the SNS.
C.6.1.3
Work Breakdown Structure
C.6.1.3.1
BARDA has provided a Contract Work Breakdown Structure (CWBS) template in Section J and Contractor shall further delineate the CWBS to Level 5 as part of their Integrated Master Project Plan. The WBS shall be discernable and consistent. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task.
C.6.2.
Risk Mitigation Plan/Matrix
C.6.2.1
The Contractor shall develop and maintain a risk management plan as outlined in section F.3 that highlights potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan should reference relevant WBS/SOW elements where appropriate. The USG has provided a Risk Mitigation Matrix template in Section J to be completed by any prospective Contractor.
C.6.3.
Earned Value Management System Plan
C.6.3.1
Earned Value Management System Plan: Subject to the requirements under HHSAR Clause 352.234-3, the Contractor shall use principles of

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.




Earned Value Management System (EVMS) in the management of this contract. The Seven Principles are:
I.
Plan all work scope for the program to completion.
II.
Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.
III.
Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control Changes to the baseline.
IV.
Use actual cost incurred and recorded in accomplishing the work performed.
V.
Objectively assess accomplishments at the work performance level.
VI.
Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.
VII.
Use earned value information in the company’s management processes.

Elements of EVMS shall be applied to all CLINs as part of the Integrated Master Project Plan, the Contractor shall submit a written summary of the management procedures that it will establish, maintain and use to comply with EVMS requirements.
C.6.4.
Performance Measurement Baseline Review (PMBR):
C.6.4.1
Performance Measurement Baseline Review (PMBR): The Contractor shall submit a plan for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as FOLLOWS:
1.
Jointly assess areas such as the Contractor’s planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks
2.
Confirm the integrity of the Performance Measurement Baseline (PMB)
3.
Foster the use of EVM as a means of communication
4.
Provide confidence in the validity of Contractor reporting
5.
Identify risks associated with the PMB
6.
Present any revised PMBs for approval

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.




7.
Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI-MGM T-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/ ).
8.
Present the Risk Management Plan
C.6.5.
Integrated Master Schedule
C.6.5.1
The Contractor shall submit as outlined in Section F.3.3 (Deliverable #5) an updated Integrated Master Schedule in a format agreed upon by BARDA to the Project Officer and the Contracting Officer for approval prior to the initiation of any activities related to the implementation of these plans. The Integrated Master Schedule shall be incorporated into the contract, and will be used to monitor performance of the contract. The Contractor shall include the key milestones and Go/No Go decision gates. The Contractor will include BARDA Portfolio Management Milestones in their IMS and provide monthly updates within their IMS. This IMS shall include the following fields at a minimum; baseline start and finish, forecast start and finish; actual start and finish, predecessor and/or successor. The Contractor shall deliver the Integrated master Schedule, viewed at the work package level in MS Project file format
C.6.6.
Earned Value Contract Performance Report (EV-CPR)
C.6.6.1
The Contractor shall deliver an Earned Value Contract Performance Report (CPR) on a monthly basis per the instruction in DI-MGMT-81466A (see http://www.acq.osd.mil/pm/ ). Contractor shall provide Format I, Format 3, and Format 5 only. Format 1 will be reported at the Work Breakdown Structure level agreed to by BARDA and the Contractor.
C.6.6.2
EV Variance thresholds will be negotiated with the Contractor post-award but for planning purposes will likely be (+/-10%). In conjunction with the CPR, the Contractor shall provide a monthly update to the IMS with up to date performance data and should include actual start/finish and projected start/finish dates.
C.6.6.3
The supplemental monthly CAP report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled (BCWS)), earned value (budgeted cost of work performed (BCWP)) and actual costs of work performed (ACWP) as captured in Contractor’s EVM systems.

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.




C.6.7.
The Contractor shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the COTR. Such meetings may include, but are not limited to, meetings of all Contractors to discuss study designs, site visits to the Contractor’s and/or subcontractor’s facilities, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. Quarterly meetings between the Program team and Contractor will occur at the Contractor’s site. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and Government-contracted subject matter experts as required by the BARDA COTR in order to facilitate review of contract activities.
C.6.8.
The Contractor shall provide a list of individuals to serve as primary and secondary points of contact who will be available 24 hours a day, seven days a week, to be notified in case of a public health emergency.
C.6.9.
The Contractor shall provide a security plan as outlined in Section J.
C.7.      Optional CLIN Objectives
C.7.1.
The USG may exercise an optional CLIN to increase the expiry period of the product to 84 months (from date of manufacture).
C.7.1.1
The Contractor shall develop a plan to conduct stability testing on BDS and FDP in conformance with FDA requirements to extend expiry dating to 84 months (from date of manufacture), and seek approval to extend the expiry dating period as appropriate. If the option is exercised, the Contractor shall implement the proposed plan to seek extended expiration dating. (CLIN 0011)
C.7.1.2
The Contractor shall develop and implement a plan to address any FDA labeling requirements, such as re-labeling product, associated with obtaining 84 -month expiration dating. (CLIN 0013)
C.7.2.
[redacted]*
C.7.3.
BARDA may exercise an optional CLIN to extend the label indication to include an intravenous (I.V.) formulation. (CLIN 0016)
C.7.3.1
The Contractor shall develop a concept plan to conduct post-approval studies to extend the label indication to include an I.V. formulation for the treatment of severely ill individuals. If the option is exercised, the Contractor shall implement the proposed plan to seek label extension to include an I.V. formulation.
C.7.4.
BARDA may exercise an optional CLIN to extend the label indication to include post event prophylactic use. (CLIN 0019)

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.




C.7.4.1
The Contractor shall develop a concept plan to conduct human and animal studies to extend the label indication to include prophylactic use of the antiviral in individuals contraindicated for vaccination, either in place of vaccination or in combination with vaccination to reduce the side effects of the live vaccine. If the option is exercised, the Contractor shall implement the proposed plan to seek label extension to include prophylactic use in vaccine-contraindicated populations.
C.7.6.
The USG may exercise an option for the Contractor to maintain a cGMP warm‑base manufacturing capability. (CLIN 0020)
C.7.6.1
The Contractor shall submit a plan to produce, release, maintain, and monitor the minimum number of lots per year of BD S, and to fill/finish the corresponding lot(s) of FDP, at a commercial scale to maintain antiviral drug cGMP capability (warm-base) for the life of the contract extension. Should the government decide to exercise the warm-base option then later exercise options for additional doses. The warm-base price shall be decremented from the Warm Base price per dose.
C.7.7.
BARDA may exercise an option to implement the Phase 4 post-marketing commitment plan, as described in Section C.4.5., to collect human safety and efficacy data when the product is used in the event of a declared emergency. (CLIN 00010)
C.7.8.
Additional Clinical and Non-Clinical Studies (CLIN 00015): Additional clinical or non-clinical studies shall be included as an optional Cost plus CLIN with a Not-To-Exceed value. The scope of work is as follows: Upon award, the Contractor shall conduct additional clinical or non-clinical studies necessary to achieve an approved CDER label indication for treatment of symptomatic adults with a smallpox infection. Modifications to this CLIN are likely due to the regulatory uncertainty of drug approval under the animal rule. Exercise of this optional CLIN will be subject to the time parameters set forth in the Project BioShield Act and determination by BARDA of a change within the scope of the Contract. (CLIN 0015)

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.




C.8.      Delivery Schedule
C.8.1.
Contractor shall propose a delivery schedule that may be subject to negotiation. The schedule for delivery of the smallpox antiviral drug shall be set forth in Section F.6 of this contract.
C.9.      Reporting Requirements
See section F.3 for specific reporting requirements.
C.9.1.
Performance of the contract will be monitored by the COTR and CO on a regular basis via teleconference every two weeks, monthly reports, and quarterly basis via site visits. The Contracting Officer will be responsible for inspection and acceptance of product; the COTR and CO will be responsible for conducting an annual performance evaluation, and facilitating the Project Coordination Team (PCT).
C.9.2.
Monitoring of the development contract will be based on periodic reporting by the Contractor. Reporting requirements and deliverables will be supplemented by quarterly visits to relevant development, manufacturing or administrative sites. The first “kick-off” site visit will be convened within 30 days of contract award to review HHS procedures, processes and expectations, as well as Contractor’s development data and plans. Program assessment will be performed by qualified subject matter experts in clinical development, engineering, manufacturing, quality control, regulatory affairs, etc.

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.




Section J.      Attachment 13
ST-246 ® Smallpox Antiviral:
Development of an ST-246 ® Oral Formulation Suitable for Dosing Population Unable to
Swallow Capsules Contract: HHSO100201100001C
CLIN 0017 and 0007
Statement of Work

The Government reserves the right to modify the milestones, progress, schedule, budget, or product to add or delete products, process, or schedule as need may arise. Because of the nature of Contract Line Item Number (CLIN 0017 and 0007) and complexities inherent in this and prior programs, at designated milestones the Government will evaluate whether work should be redirected, removed, or whether schedule or budget adjustments should be made. In any event, the Government reserves the right to change product, process, schedule, or event to add or delete part or all of these elements as the need arises subject to FAR 52.243-2 Changes - Cost - Reimbursement.
Statement of Work (SOW)
[redacted]*


* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

Exhibit 10.7

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
1. CONTRACT ID CODE

PAGE OF PAGES
   1          3
2. AMENDMENT/MODIFICATION NO
0018
3. EFFECTIVE DATE
See Block 16C
4. REQUISITION/PURCHASE REQ NO
5. PROJECT NO. (if applicable.) ,  
6. ISSUED BY CODE
HHS/OS/ASPR/BARDA
330 Independence Ave., S.W.
Room 640-G
Washington DC 20201
HHS/OS/ASPR/BARDA
7 ADMINISTERED BY (if other than Item 6) CODE
ASPR-BARDA
330 Independence Ave, SW, Rm G640
Washington DC 20201
ASPR-BARDA02
 
 
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
SIGA TECHNOLOGIES, INC. 1385150
SIGA TECHNOLOGIES, INC. 35 E 6
35 E 62ND ST
NEW YORK NY 100658014
(x)
9A. AMENDMENT OF SOLICITATION NO
9B. DATED (SEE ITEM 11)
x
10A. MODIFICATION OF CONTRACT/ORDER NO.
HHSO100201100023C
10B. DATED (SEE ITEM 13)

06/01/2011
CODE     1385150
FACILITY CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
The above numbered solicitation is amended as set forth In Item 14. The hour and data specified for receipt of Offers is extended. is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing Items 8 and 15, and returning ___ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF•YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required.)    Net Decrease:          -$570,919.10
See Schedule
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
CHECK ONE
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO : (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
 
B. THE ABOVE NUM8ERBD CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.)  SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
X
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
FAR 1.602-1; FAR 52.243-2 Changes – Cost Reimbursement – Alt V (Apr 1984); and Mutual Agreement
 
D. OTHER (Specify type of modification and authority.)
E. IMPORTANT: Contractor  is not.  is required to sign this document and return ___1___ copies to the issuing office.
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
Tax ID Number: 13-3864870
DONS Number: 932651516
PURPOSE: This modification is to remove expiring funds from the contract.

FUNDS ALLOTED PRIOR TO MOD #18 $37,375,485.00
FUNDS REMOVED WITH MOD #18 - $570,919.10
TOTAL FUNDS ALLOTED TO DATE $36,804,565.90 (Changed)

CONTRACT EXPIRATION DATE: December 30, 2020 (Unchanged)

Continued . . .

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
15A. NAME AND TITLE OF SIGNER (Type or print.)
Phillip L. Gomez, III CEO
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print.)
ELIZABETH STEINER
15B. CONTRACTOR/OFFEROR
/s/ Phillip L. Gomez, III
(Signature of person authorized to sign.)
15C. DATE SIGNED

28 Sep 2018
16B. UNITED STATES OF AMERICA
/s/ Elizabeth Steiner
(Signature of contracting officer.
16. DATE SIGNED

9/28/18



CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100023C/0018
PAGE OF PAGES
   2 3
NAME OF OFFEROR OR CONTRACTOR
  SIGA TECHNOLOGIES, INC. 1385150
ITEM NO.
(A)
SUPPLIES/SERVICES
(B)
QUANTITY
(C)
UNIT
(D)
UNIT PRICE
(E)
AMOUNT
(F)
 
 
CLIN 0002 POP 30Sept2018 (Unchanged)
 
 
 
 
 
 
CLIN 0003 POP 30Dec2019 (Unchanged)
 
 
 
 
 
 
CLIN 0004 POP 30Dec2020 (Unchanged)
 
 
 
 
 
 
CLIN 0005 POP 30Dec2020 (Unchanged)
 
 
 
 
 
 
CLIN 0006 POP 30June2020 (Unchanged)
 
 
 
 
 
 
CLIN 0007 POP 30Dec2020 (Unchanged)
 
 
 
 
 
 
CLIN 0008 POP 30Dec2020 (Unchanged)
 
 
 
 
 
 
CLIN 0011 POP 28Feb2014 (Unchanged)
 
 
 
 
 
 
CLIN 0012 POP 31Dec2016 (Unchanged)
 
 
 
 
 
 
CLIN 0013 POP 31Dec2013 (Unchanged)
 
 
 
 
 
 
1) The following revision is made to CLINs 0002,0011, 0012, and 0013 under this modification:
 
 
All remaining funds in CLINs 0002,0011, 0012, and 0013 are being deobligated in full due to the funds expiring.
 
 
The amount of decrease for CLIN 0002 is $408,689.27.
 
 
 
 
 
 
The amount of decrease for CLIN 0011 is $1,069.53.
 
 
 
 
 
 
The amount of decrease for CLIN 0012 and 0013 is $161,160.30.
 
 
 
 
 
 
This change reduces the overall contract value from Not to Exceed $37,375,485.00 to Not to Exceed $36,804,565.90, a decrease of $570,919.10 (overall contract value).
Delivery Location Code: OS-BARDA-SWITZER
OS-BARDA-SWITZER
330 Independence Ave, SW, Rm G644
Washington DC 20201 US
 
 
 
 
 
 
 
 
 
 
 
 
FOB: Destination
 
 
 
 
 
 
Period of Performance: 05/15/2011 to 12/30/2020
 
 
 
 
 
 
Change Item 3 to read as follows (amount shown is the obligated amount):
 
3
CLIN 0002 funding to SIGA Technologies, Inc. CAN
 
 
 
-408,689.27
 
 
1992002 HHSO1002011000023C
 
 
 
 
 
 
Delivery: 02/18/2018
Accounting Info:
2011.1992002.25329 Appr. Yr.: 2011 CAN: 1992002 Object Class: 25329
Funded: -$408,689.27
 
 
 
 
 
 
 
 
 
Change Item 4 to read as follows (amount shown is the obligated amount):
 
4
CLIN 0011 funding to SIGA Technologies, Inc. CAN

 
 
 
-1,069.53
 
 
Continued . . .

 
 
 
 
 



CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100023C/0018
PAGE OF PAGES
   3 3
 
 
 
 
 
NAME OF OFFEROR OR CONTRACTOR
SIGA TECHNOLOGIES, INC. 1385150
ITEM NO.
(A)
SUPPLIES/SERVICES
(B)
QUANTITY
(C)
UNIT
(D)
UNIT PRICE
(E)
AMOUNT
(F)
 
5
1992002 HHSO1002011000023C
Delivery: 03/21/2013
Accounting Info:
2011.1992002.25329 Appr. Yr.: 2011 CAN: 1992002 Object Class: 25329
Funded: -$1,069.53
Change Item 5 to read as follows (amount shown is the obligated amount):
ST-246 Smallpox Antiviral Funding of goods or services to exercise CLIN0012 and CLIN 0013
Accounting Info:
2012.1992002.25329 Appr. Yr.: 2012 CAN: 1992002 Object Class: 25329
Funded: -$161,160.30
 
 
 
-161,160.30


NSN 754041. 152-8070        STANDARD FORM 30 (REV. 1043.3)
Previous edition unusable        Prescribed by GSA
FAR (48 CFR) 53 243



Exhibit 31.1
 
Certification by Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
 
I, Phillip L. Gomez, Ph.D., certify that:
 
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 6, 2018
 
/s/ Phillip L. Gomez, Ph.D.
Phillip L. Gomez, Ph.D.
Chief Executive Officer





Exhibit 31.2
 
Certification by Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
 
I, Daniel J. Luckshire, certify that:
 
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 6, 2018
 
/s/ Daniel J. Luckshire
Daniel J. Luckshire
Executive Vice President and
Chief Financial Officer





Exhibit 32.1
 
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
In connection with the Quarterly Report of SIGA Technologies, Inc. (the “Company”) on Form 10-Q for the quarterly period ended September 30, 2018 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Phillip L. Gomez, Ph. D., Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
 
(1)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
 
/s/ Phillip L. Gomez, Ph.D.
Phillip L. Gomez, Ph.D.
Chief Executive Officer
November 6, 2018





Exhibit 32.2  

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
In connection with the Quarterly Report of SIGA Technologies, Inc. (the “Company”) on Form 10-Q for the quarterly period ended September 30, 2018 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Daniel J. Luckshire, Executive Vice President and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
 
(1)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
 
/s/ Daniel J. Luckshire
Daniel J. Luckshire
Executive Vice President and Chief Financial Officer
November 6, 2018