Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

 

Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the Quarterly Period Ended June 30, 20202021

 

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 incorporation or organization)

(IRS Employer Identification. No.)

 

 

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

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

common stock, $.0001 par value

SIGA

The Nasdaq Global Market

 

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 ☒ No ☐.

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes ☒ 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

Non-accelerated filer 

Smaller reporting company ☒

 

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 ☒.

 

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 ☐ No ☐.

As of July 30, 2020,23, 2021, the registrant had outstanding 78,120,81175,076,665 shares of common stock, par value $.0001, per share.

 

 

 

 

SIGA TECHNOLOGIES, INC.
FORM 10-Q

 

Table of Contents

 

 

 

Page No.

PART I-FINANCIAL INFORMATION

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

2

Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

1517

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

1923

Item 4.

Controls and Procedures

1923

 

 

 

PART II- OTHERII-OTHER INFORMATION

Item 1.

Legal Proceedings

2024

Item 1A

Risk Factors

2024

Item 2.

Unregistered SaleSales of Equity Securities and Use of Proceeds

2024

Item 3.

Defaults upon Senior Securities

2024

Item 4.

Mine Safety Disclosures

2024

Item 5.

Other Information

2024

Item 6.

Exhibits

2125

SIGNATURES

 

2226

 

 


 

 

 

PART I - FINANCIAL INFORMATION

Item 1 - Condensed Consolidated Financial Statements 

SIGA TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

 

 

June 30, 2020

  

December 31, 2019

  

June 30, 2021

  

December 31, 2020

 

ASSETS

        

Current assets

        

Cash and cash equivalents

 $53,065,833  $65,249,072  $98,486,013  $117,890,240 

Restricted cash and cash equivalents, short-term

 -  95,737,862 

Accounts receivable

 36,611,661  4,167,996  7,206,135  3,340,263 

Inventory

 14,006,986  9,652,855  19,599,891  20,265,519 

Prepaid expenses and other current assets

  1,382,499   5,234,000   1,774,218   2,112,069 

Total current assets

 105,066,979  180,041,785  127,066,257  143,608,091 
  

Property, plant and equipment, net

 2,366,135  2,618,303  2,597,296  2,103,990 

Deferred tax assets, net

 11,183,600  14,151,002 

Deferred income taxes, net

 2,731,473  2,544,053 

Goodwill

 898,334  898,334  898,334  898,334 

Other assets

  901,906   856,766   392,665   676,923 

Total assets

 $120,416,954  $198,566,190  $133,686,025  $149,831,391 

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities

        

Accounts payable

 $630,165  $3,054,032  $675,403  $1,278,217 

Accrued expenses and other current liabilities

 14,931,370  8,636,911   7,295,055   9,205,293 
Total debt, current  -   80,044,866 

Total current liabilities

 15,561,535  91,735,809  7,970,458  10,483,510 

Warrant liability

 7,752,534  6,116,882  5,278,141  6,639,211 

Other liabilities

  2,969,867   2,929,743   3,716,464   2,915,401 

Total liabilities

 26,283,936  100,782,434  16,965,063  20,038,122 

Commitments and contingencies

                

Stockholders’ equity

        

Common stock ($.0001 par value, 600,000,000 shares authorized, 78,618,743 and 81,269,868 issued and outstanding at June 30, 2020, and December 31, 2019, respectively)

 7,862  8,127 

Common stock ($.0001 par value, 600,000,000 shares authorized, 75,389,417 and 77,195,704, issued and outstanding at June 30, 2021 and December 31, 2020, respectively)

 7,539  7,720 

Additional paid-in capital

 221,380,828  220,808,037  225,678,876  224,978,430 

Accumulated deficit

  (127,255,672)  (123,032,408)  (108,965,453)  (95,192,881)

Total stockholders’ equity

  94,133,018   97,783,756   116,720,962   129,793,269 

Total liabilities and stockholders’ equity

 $120,416,954  $198,566,190  $133,686,025  $149,831,391 

 

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

 

2


 

 

SIGA TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (UNAUDITED)

 

 

Three Months Ended June 30,

  

Six Months Ended June 30,

  

Three Months Ended June 30,

  

Six Months Ended June 30,

 
 

2020

  

2019

  

2020

  

2019

  

2021

  

2020

  

2021

  

2020

 

Revenues

          

Product sales and supportive services

 $38,624,450  $-  $38,737,459  $7,142,400  $6,924,162  $38,624,450  $10,447,505  $38,737,459 

Research and development

  1,724,327   3,907,611   4,231,083   7,224,295   1,729,127   1,724,327   3,019,528   4,231,083 

Total revenues

 40,348,777  3,907,611  42,968,542  14,366,695  8,653,289  40,348,777  13,467,033  42,968,542 
  

Operating expenses

          

Cost of sales and supportive services

 4,796,768  -  4,905,863  915,367  995,990  4,796,768  1,246,838  4,905,863 

Selling, general and administrative

 3,870,927  3,392,228  7,046,952  6,558,794  5,216,059  3,870,927  9,272,243  7,046,952 

Research and development

 2,709,743  2,038,323  5,859,847  6,035,604  2,263,971  2,709,743  4,566,756  5,859,847 

Patent expenses

  174,203   182,310   356,800   370,226   176,167   174,203   369,501   356,800 

Total operating expenses

  11,551,641   5,612,861   18,169,462   13,879,991   8,652,187   11,551,641   15,455,338   18,169,462 

Operating income (loss)

 28,797,136  (1,705,250) 24,799,080  486,704 

(Loss) gain from change in fair value of warrant liability

 (1,619,587) 656,523  (1,635,652) 3,792,788 

Operating income/(loss)

 1,102  28,797,136  (1,988,305) 24,799,080 

Gain/(loss) from change in fair value of warrant liability

 442,269  (1,619,587) 1,361,070  (1,635,652)
Loss on extinguishment of Term Loan - - (4,981,461) -  0  0  0  (4,981,461)

Interest expense

 -  (3,971,031) (3,016,817) (7,899,449) 0  0  0  (3,016,817)

Other income, net

  31,931   737,577   444,295   1,473,706   24,235   31,931   49,803   444,295 

Income (loss) before income taxes

 27,209,480  (4,282,181) 15,609,445  (2,146,251)

(Provision) benefit for income taxes

  (6,319,322)  1,119,689   (3,616,816)  613,536 

Net and comprehensive income (loss)

 $20,890,158  $(3,162,492) $11,992,629  $(1,532,715)

Basic income (loss) per share

 $0.26  $(0.04) $0.15  $(0.02)

Diluted income (loss) per share

 $0.26  $(0.05) $0.15  $(0.06)

Income/(loss) before income taxes

 467,606  27,209,480  (577,432) 15,609,445 

Provision for income taxes

  (298,406)  (6,319,322)  (65,473)  (3,616,816)

Net and comprehensive income/(loss)

 $169,200  $20,890,158  $(642,905) $11,992,629 

Basic income/(loss) per share

 $0.00  $0.26  $(0.01) $0.15 

Diluted (loss)/income per share

 $(0.00) $0.26  $(0.03) $0.15 

Weighted average shares outstanding: basic

  80,340,695   80,986,524   80,790,400   80,950,124   75,810,641   80,340,695   76,281,211   80,790,400 

Weighted average shares outstanding: diluted

  80,516,863   82,114,661   80,959,812   82,129,601   76,660,054   80,516,863   77,128,973   80,959,812 

 

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

 

3


 

 

SIGA TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

 

 

Six Months Ended June 30,

  

Six Months Ended June 30,

 
 

2020

  

2019

  

2021

  

2020

 

Cash flows from operating activities:

  

Net income/(loss)

 $11,992,629  $(1,532,715)

Adjustments to reconcile net income/(loss) to net cash used in operating activities:

 

Net (loss)/income

 $(642,905) $11,992,629 

Adjustments to reconcile net loss to net cash used in operating activities:

 

Depreciation and other amortization

 267,669  265,289  264,834  267,669 

Loss/(gain) on change in fair value of warrant liability

 1,635,652  (3,792,788)

(Gain)/loss on change in fair value of warrant liability

 (1,361,070) 1,635,652 

Stock-based compensation

 582,549  956,284  713,817  582,549 

Loss on inventory, net

 630,707  0 

Deferred income taxes, net

 2,967,402  (655,139) (187,420) 2,967,402 
Loss on extinguishment of Term Loan 4,981,461  -  0  4,981,461 

Non-cash interest expense

 887,132  2,230,153  0  887,132 

Changes in assets and liabilities:

  

Accounts receivable

 (32,443,665) (2,169,083) (3,865,872) (32,443,665)

Inventory

 (1,751,459) 517,724  34,921  (1,751,459)

Prepaid expenses and other assets

 1,203,690  942,599  622,109  1,203,690 

Accounts payable, accrued expenses and other liabilities

 (4,421,690) (2,304,892) (2,819,298) (4,421,690)

Deferred revenue

  8,332,405   1,204,135   373,593   8,332,405 

Net cash used in operating activities

  (5,766,225)  (4,338,433)  (6,236,584)  (5,766,225)

Cash flows from investing activities:

  

Capital expenditures

  (15,501)  (8,948)  (24,424)  (15,501)

Net cash used in investing activities

  (15,501)  (8,948)  (24,424)  (15,501)

Cash flows from financing activities:

  

Payment of employee tax obligations for common stock tendered

 (9,746) (56,590) (13,361) (9,746)
Repurchase of common stock (16,216,170) -  (13,129,858) (16,216,170)
Repayment of Term Loan  (85,913,459)  -   0   (85,913,459)

Net cash used in financing activities

  (102,139,375)  (56,590)  (13,143,219)  (102,139,375)

Net decrease in cash, cash equivalents and restricted cash

 (107,921,101) (4,403,971) (19,404,227) (107,921,101)

Cash, cash equivalents and restricted cash at the beginning of period

  160,986,934   180,396,910   117,890,240   160,986,934 

Cash, cash equivalents and restricted cash at end of period

 $53,065,833  $175,992,939 
 

Supplemental disclosure of non-cash activities:

 

Conversion of warrants to common stock

 $-  $1,172,801 

Issuance of common stock upon cashless exercise

 $-  $118,500 

Cash and cash equivalents at end of period

 $98,486,013  $53,065,833 

 

The accompanying notes are an integral part of these financial statements

 

4


 

SIGA TECHNOLOGIES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

 

1. Condensed Consolidated Financial Statements

 

The financial statements of SIGA Technologies, Inc. (“we,” “our,” “us,” “SIGA” or the “Company”) 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, 20192020, included in the Company's 20192020 Annual Report on Form 10-K.-K filed on March 4, 2021 (the "2020 Form 10-K"). All terms used but not defined elsewhere herein have the meaning ascribed to them in the Company’s 20192020 Annual Report on Form 10-K filed on March 5, 2020. -K. 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 have been included. The 20192020 year-end condensed consolidated balance sheet data were derived from the audited financial statements but do not include all disclosures required by U.S. GAAP. The results of operations for the three and six months ended June 30, 20202021 are not necessarily indicative of the results expected for the full year.

 

 

2. Summary of Significant Accounting Policies

 

Revenue Recognition

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”). In all transactions, the Company is the principal as it controls the specified good or service before it is transferred to the customer and therefore recognizes revenue on a gross basis. A contract’s transaction price is allocated to distinct performance obligations and recognized as revenue when, or as, a performance obligation is satisfied. As of June 30, 20202021, the Company's active performance obligations, for the contracts outlined in Note 3, consist of the following: six performance obligations relate to research and development services; two relate to manufacture and delivery of product; and one is associated with storage of product. The aggregate amount of the transaction price allocated to remaining performance obligations was $142.8$68.0 million as of June 30, 20202021. Remaining performance obligations represent the transaction price for which work has not been performed and excludes unexercised contract options.

 

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. 

 

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.  All of the Company’s revenue related to current research and development performance obligations is recognized over time, because the customer simultaneously receives and consumes the benefits provided by the services as the Company performs these services. The Company recognizes revenue related to these services based on the progress toward complete satisfaction of the performance obligation and measures this progress under an input method, which is based on the Company’s cost incurred relative to total estimated costs.  Under this method, progress is measured based on the cost of resources consumed (i.e., cost of third-party services performed, cost of direct labor hours incurred, and cost of materials consumed) compared to the total estimated costs to completely satisfy the performance obligation. Incurred costs represent work performed, which corresponds with, and thereby best depicts, the transfer of control to the customer. The incurred and estimated costs used in the measure of progress include third-party services performed, direct labor hours, and material consumed.

 

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 sheets. 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; as of June 30, 20202021, the accounts receivable balance in the condensed balance sheet includes approximately $2.5$6.1 million of unbilled receivables. This amount includes net proceeds (net of Meridian fee) from international sales, which are billed and collected by Meridian and paid to SIGA. 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 from billing. 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. During the six months ended June 30, 20202021, the Company recognized revenueless than $0.1 million of $0.1 million thatrevenue that was included in deferred revenue at the beginning of the period. 

Restricted Cash and Cash Equivalents

On March 13, 2020, the Company repaid its Term Loan and restrictions on certain cash accounts were removed.  Prior to the repayment of the Term Loan, there were restrictions on certain cash accounts. Under the terms of the Loan Agreement (as defined below), net cash proceeds from the Company's Priority Review Voucher ("PRV") sale on October 31, 2018 were restricted and were held in a reserve account (as required under the Loan Agreement related to the Term Loan). Cash and cash equivalents held in the reserve account were available to pay interest, fees and principal related to the Term Loan. See Note 8 for additional information. Prior to the second quarter of 2019, there was also a reserve account for certain proceeds of the Term Loan. This account was also restricted. Amounts in this reserve account were primarily used to pay interest on the Loan Agreement. This reserve account was closed in the second quarter 2019.

 

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

  

As of

 
  

June 30, 2020

  

December 31, 2019

 

Cash and cash equivalents

 $53,065,833  $65,249,072 

Restricted cash-short term

     95,737,862 
Cash, cash equivalents and restricted cash $53,065,833  $160,986,934 

  

June 30, 2019

  

December 31, 2018

 

Cash and cash equivalents

 $100,263,915  $100,652,809 

Restricted cash-short term

  11,248,400   11,452,078 

Restricted cash-long term

  64,480,624   68,292,023 

Cash, cash equivalents and restricted cash

 $175,992,939  $180,396,910 

5

Repurchase of shares

When shares recognized as equity are repurchased, the amount of the consideration paid, which includes directly attributable costs, is recognized as a deduction from equity. The excess of the purchase price above par value of repurchased shares that are retired is presented as an increase to accumulated deficit (or a reduction of retained earnings, if any).

Recent Accounting Pronouncements 

In December 2019, the FASB issued ASU No.2019-12,Simplifying the Accounting for Income Taxes, as part of its initiative to reduce complexity in accounting standards. The amendments in the ASU are effective for fiscal years beginning after December 15, 2020, including interim periods therein. The adoption of this standard in the first quarter of 2021 had no impact on the condensed consolidated financial statements.

 

 

3. Procurement Contracts and Research Agreements

 

19C 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 U.S. Strategic National Stockpile ("Strategic Stockpile"), and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of the intravenous (IV) formulation of TPOXX® ("(“IV TPOXX®"). Additionally, the contract includes funding from BARDA for advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, and procurement activities. As of June 30, 20202021, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $602.5 million of payments, of which approximately $51.7 million of payments are included within the base period of performance of five years, approximately $127.1 million of payments are related to exercised options and up to approximately $423.7 million of payments are currently specified as unexercised options. BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term, including during the base period of performance. On May 20, 2019, an option for the manufacture and delivery of 363,070 courses of oral TPOXX® was modified to divide it into four procurement-related options. One of the four modified procurement-related options provides for the payment of $11.2 million for the procurement of raw materials to be used in the manufacture of at least 363,070 courses of oral TPOXX®. This option was exercised simultaneously with the aforementioned modification. Each of the other three options individually specifies the delivery of approximately 121,000 courses of oral TPOXX® for consideration of approximately $33.8 million. These options were exercised on April 29, 2020. In total, the four options under the May 2019 modification provide for the purchase of raw material for and the manufacture and delivery of 363,070 courses of oral TPOXX® for consideration of approximately $112.5 million. The option modification did not change the overall total potential value of the 19C BARDA Contract, nor did it change the total amount to be paid in connection with the manufacture and delivery of oral TPOXX® courses.

 

The base period of performance specifies potential 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® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund advanced development of IV TPOXX®; and payments of approximately $0.6 million for supportive procurement activities. As of June 30, 20202021, the Company had received or billed for $11.1 million for the successful delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS and $4.7$11.0 million for other base period activities. IV BDS is expected to be used for the manufacture of 20,000 courses of IV FDP. The $3.2 million received for the manufacture of IV BDS has been recorded as deferred revenue as of June 30, 20202021 and December 31, 20192020; such amount is expected to be recognized as revenue when IV TPOXX® containing such IV BDS is delivered to the Strategic Stockpile or placed in vendor-managed inventory.

 

The options that have been exercised to date provide for payments up to approximately $127.1 million. There are exercised options for the following activities: payments up to $11.2 million for the procurement of raw materials to be used in the manufacture of at least 363,070 courses of oral TPOXX®,; payments up to $101.3 million for the delivery of up to 363,070 courses of oral TPOXX®; and payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX®. As of June 30, 2021, the Company has received the following payments in connection with exercised options: $11.2$112.5 million was received for the procurement of raw materials and such amount was initially recorded as deferred revenue,in connection with $3.6 million of this amount being recognized as revenue due to thedeliveries made in June 2020delivery of approximately 117,000363,000 courses of oral TPOXX® (the remaining $7.6 million of deferred revenue is expected to be recognized as revenue when additional courses of oral TPOXX®, containing raw materials for which the Company has been paid, are delivered to the Strategic Stockpile or placed in vendor-managed inventory); and $2.3$6.8 million has been received or billed for in connection with post-marketing activities for oral TPOXX®. In July, the Company received a $32.6 million payment for the June delivery of approximately 117,000 courses of oral TPOXX®; in the second quarter, 2020, $36.2 million of revenue was recognized in connection with this product delivery, of which $32.6 million relates to the amount invoiced for product delivery and acceptance, and $3.6 million relates to amounts that were previously received and recorded as deferred revenue. 

 

Unexercised options specify potential payments up to approximately $423.7 million in total (if all such options are exercised). There are options for the following activities: payments of up to $337.7 million for the delivery of up to approximately 1,089,000 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 IV FDP, of which up to $30.7$30.7 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP; payments of up to approximately $3.6 millionmillion to fund post-marketing activities for IV TPOXX®; and payments of up to approximately $5.6 million for supportive procurement activities.

6

 

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 19C 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 as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to make independent exercise decisions.options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option). 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. For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 64,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP.

 

Revenues in connection with the 19C BARDA Contract are recognized either over time or at a point in time. Performance obligations related to product delivery generate revenue at a point in time. Revenue forfrom other performance obligations under the 19C BARDA Contract are recognized over time using an input method using costs incurred to date relative to total estimated costs at completion. For the three months ended June 30, 20202021 and 20192020, the Company recognized revenues of $1.4$0.8 million and $0.4$1.4 million, respectively, on an over time basis. For the six months ended June 30, 20202021 and 20192020, the Company recognized revenuesrevenue of $3.5$1.7 million and $1.7$3.5 million, respectively, on an over time basis. In contrast, 0 revenue was recognized for product delivery, and therefore 0 revenue was recognized at a point in time, for the three and six months ended June 30, 2021. Revenue recognized for product delivery, and therefore recognized at a point in time, for the three and six months ended June 30, 2020, was $36.2 million. For the six months ended June 30, 2019, the Company recognized $7.1 million of revenue at a point in time.

6

2011 BARDA Contract

On May 13, 2011, the Company signed a contract with BARDA pursuant to which 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.

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 $508.4 million of payments (including exercised options), of which, as of June 30, 2020, $459.8 million has been received by the Company for the manufacture and delivery of 1.7 million courses of oral TPOXX® and $45.4 million has been received for certain reimbursements in connection with development and supportive activities. Approximately $3.2 million remains eligible to be received in the future for reimbursements of development and supportive activities.

For courses of oral TPOXX® that have been physically delivered to the Strategic Stockpile under the 2011 BARDA Contract, there are product replacement obligations, including: (i) a product replacement obligation in the event that the final version of oral TPOXX® approved by the FDA was different from any courses of oral TPOXX® that had been delivered to the Strategic Stockpile (the “FDA Approval Replacement Obligation”); (ii) 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; and (iii) a product replacement obligation in the event that oral TPOXX® does not meet any specified label claims. 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. As such, the possibility of the FDA Approval Replacement Obligation resulting in any future replacements of product within the Strategic Stockpile is remote.

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 the aforementioned 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 post-exposure prophylaxis ("PEP") 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.

The 2011 BARDA Contract expires in September 2020.

Revenues in connection with the 2011 BARDA Contract are recognized either over time or at a point in time. Performance obligations related to product delivery generate revenue at a point in time. Remaining performance obligations under the 2011 BARDA Contract generate revenue over time, using an input method of costs incurred to date relative to the total estimated costs at completion. For the three months ended June 30, 2020 and 2019, the Company recognized revenue of approximately $0.1 million and $0.1 million, respectively, on an over time basis. For the six months ended June 30, 2020 and 2019, the Company recognized revenue of $0.1 million and $0.2 million, respectively on an over time basis. In contrast, there was 0 revenue recognized for product delivery and therefore at a point in time for the three and six months ended June 30, 2020 or 2019.

 

International Procurement Contracts

On January 13, 2021, the Public Health Agency of Canada ("PHAC") awarded a contract to Meridian Medical Technologies, Inc. (“Meridian,” a Pfizer Company) (the “Contract”) for the purchase of up to approximately $33 million of oral TPOXX® (tecovirimat) within five years. The Contract specifies firm commitments for the cumulative purchase of approximately $17 million of oral TPOXX® by March 31, 2023; the remaining courses under the Contract are targeted for delivery after March 31, 2023 and are subject to option exercise by PHAC. 

On April 3, 2020, the Company announced that the Canadian Department of National Defence (the “CDND”(“CDND”) awarded a contract (the "Canadian Military Contract") to Meridian, Medical Technologies, Inc., a Pfizer Company ("Meridian"), pursuant to which the CDND will purchase up to 15,325 coursesapproximately $14 million of oral TPOXX® over four years for total potential payments of $14.3 million.years. In the second quarter 2020, CDND purchased 2,500 courses for $2.3 million.million of oral TPOXX®. The remaining purchases are at the option of the CDND, and are expected to primarily occur after regulatory approval of oral TPOXX® in Canada. Meridian is the CDND's counterparty under the Canadian Military Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder. For the six months ended June 30, 2021, there were no deliveries under this contract.

The PHAC and CDND contract award wasawards were both coordinated between SIGA and Meridian under the international promotion agreement (the(as amended, the "International Promotion Agreement") that was entered into by the parties on June 3, 2019.

 

Under the terms of the International Promotion Agreement, Meridian was granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States and South Korea (the “Territory”), and Meridian has agreed not to commercialize any competing product, as defined in the International Promotion Agreement, in the specified field of use in the Territory. SIGA will retain ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States and South Korean markets,market, will also retain sales and marketing rights with respect to oral TPOXX®. SIGA’sSIGA���s consent shall be required for the entry into any sales arrangement pursuant to the International Promotion Agreement.

 

The fee Meridian retains pursuant to the International Promotion Agreement will be a specified percentage of the collected proceeds of sales of oral TPOXX® net of certain expenses, for years in which customer invoiced amounts net of such expenses are less than or equal to a specified threshold, and a higher specified percentage of such collected net proceeds for years in which such net invoiced amounts exceed the specified threshold.

 

Revenue in connection with international procurement contracts for the delivery of product are recognized at a point in time. During the three and six months ended June 30, 20202021, the Company recognized $2.3$6.9 million and $10.3 million of revenue.revenue, respectively, for delivery to PHAC. 

 

7

Research Agreements and Grants

The Company has an R&D program for IV TPOXX®. This program is funded by the 19C BARDA Contract and a separate development contract with BARDA (“("IV Formulation R&D Contract”Contract"). The IV Formulation R&D Contract has a period of performance that terminates in February 2024. As of June 30, 20202021, the IV Formulation R&D Contract provides for future aggregate research and development funding of up to approximately $2.2$1.0 million.

Revenues in connection with the IV Formulation R&D Contract are recognized over time, under an input method using costs incurred to date relative to the total estimated costs of completion.time. For the three months ended June 30, 20202021 and 20192020, the Company recognized revenue of $0.3 million and $3.4$0.3 million, respectively.respectively, under this contract. For the six months ended June 30, 20202021 and 20192020, the Company recognized revenue of $0.7$0.5 million and $5.3$0.7 million, respectively, under this contract. During the three months ended June 30, 2019, the Company completed its negotiation with representatives of the U.S. government for a change in the application of certain reimbursement rates in the contract.  The change in the application of those reimbursement rates increased the overall transaction price of the IV Formulation R&D Contract but did not change the estimate of costs to complete under the input method calculation.  As a result, the Company accounted for this as a change in the transaction price and recognized a cumulative catch-up adjustment to revenue of approximately $3.3 million representing the impact of the change in the application of those reimbursement rates from January 2016 through March 2019.

 

In July 2019, the Company was awarded a multi-year research contract valued at a total of $19.5 million, with an initial available fundingaward of $12.4 million, from the United States Department of Defense ("DoD") to support work in pursuit of a potential label expansion for oral TPOXX® that would include post-exposure prophylaxis ("PEP") of smallpox (such work known as the "PEP Label Expansion Program" and the contract referred to as the "PEP Label Expansion R&D Contract"). In May 2020, the DoD increased the scope and the contract value to a total ofof $26 million with current available funding of $23 million. As In April 2021, the DoD increased the available funding to the full contractual value of June 30, 2020, the PEP Label Expansion R&D Contract provides for future aggregate research and development funding under the initial award of up to approximately $22.6$26 million. The period of performance for this contract, as modified, terminates on July 31, 2025.April 30, 2024. For the three and six months ended June 30, 2021 and 2020, the Company, under the PEP Label Expansion R&D Contract, recognized revenue of $0.5 million and less than $0.1 million, respectively, on an over time basis. For the six months ended June 30, 2021 and 2020, the Company, under the PEP Label Expansion R&D Contract, recognized revenue of $0.6 million and of less than $0.1 million, respectively, on an over time basis.

On May 13, 2011, the Company signed a contract with BARDA ("2011 BARDA Contract") pursuant to which 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.

The 2011 BARDA Contract specifies approximately $508.4 million of payments, of which, as of June 30, 2021, $459.8 million has been received by the Company for the manufacture and delivery of 1.7 million courses of oral TPOXX® and $45.8 million has been received for certain reimbursements in connection with development and supportive activities. Approximately $2.8 million remains eligible to be received in the future for reimbursements of development and supportive activities.

The 2011 BARDA Contract expires in December 2024.

Remaining performance obligations under the 2011 BARDA Contract generate revenue over time. For the three months ended June 30, 2021 and 2020, the Company recognized revenue of less than $0.1 million and approximately $0.1 million, respectively, on an over time basis. For the six months ended June 30, 2021 and 2020, the Company recognized revenue of $0.1 million and $0.1 million, respectively, on an over time basis.

 

Contracts and grants include, among other things, options that may or may not be exercised at the U.S. Government’s discretion. Moreover, contracts and grants contain customary terms and conditions including the U.S. Government’s right to terminate or restructure a contract or grant for convenience at any time. As such, wethe Company may not be eligible to receive all available funds.

8

 

4. Inventory

 

Inventory includes costs related to the manufacture of TPOXX®. Inventory consisted of the following:

 

 

As of

  

As of

 
 

June 30, 2020

  

December 31, 2019

  

June 30, 2021

 

December 31, 2020

 
Raw materials $2,602,672 $-  $14,908 $2,628,153 

Work in-process

  11,315,916   8,693,457   17,844,691   15,415,425 

Finished goods

  88,398   959,398   1,740,292   2,221,941 

Inventory

 $14,006,986  $9,652,855  $19,599,891  $20,265,519 

For the three and six months ended June 30, 2021, cost of goods sold included a net inventory-related loss of $0.6 million. This loss related to a $0.9 million inventory write-down, partially offset by credits received from contract manufacturing organizations ("CMOs") in connection with the inventory write-down.

 

 

5. Property, Plant and Equipment

 

Property, plant and equipment consisted of the following: 

 

 

As of

  

As of

 
 

June 30, 2020

  

December 31, 2019

  

June 30, 2021

 

December 31, 2020

 

Leasehold improvements

 $2,420,028  $2,420,028  $2,420,028  $2,420,028 

Computer equipment

 617,298  601,797  484,866  532,125 

Furniture and fixtures

 377,859  377,859  377,859  377,859 

Operating lease right-of-use assets

  2,944,932   2,944,932   3,678,647   2,944,932 
 6,360,117  6,344,616  6,961,400  6,274,944 

Less - accumulated depreciation and amortization

  (3,993,982)  (3,726,313)  (4,364,104)  (4,170,954)

Property, plant and equipment, net

 $2,366,135  $2,618,303  $2,597,296  $2,103,990 

 

Depreciation and amortization expense on property, plant, and equipment was $267,669$0.3 million and $265,289$0.3 million for the six months ended June 30, 20202021 and 20192020, respectively.

 

 

6. Accrued Expenses and Other Current Liabilities

 

Accrued expenses and other current liabilities consisted of the following:

 

 

As of

  

As of

 
 

June 30, 2020

  

December 31, 2019

  

June 30, 2021

 

December 31, 2020

 

Deferred revenue

 $3,654,540  $3,280,947 

Compensation

 $1,747,880  $2,966,139   1,672,113   2,933,738 

Deferred revenue

 10,630,746  2,298,341 

Interest payable

   977,724 

Professional fees

 630,506  251,824 

Lease liability, current portion

 434,132  419,709  433,437  449,940 

Research and development vendor costs

 298,626  707,685 

Professional fees

 447,451  288,707 

Vacation

 438,599  256,402  432,621  405,176 

Other

  933,936   722,204  278,788  486,158 

Research and development vendor costs

 144,973  327,606 

Income tax payable

 27,407 919,555 

Inventory

  20,670  150,349 

Accrued expenses and other current liabilities

 $14,931,370  $8,636,911  $7,295,055  $9,205,293 

 

 

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 (as defined in Note 8) 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 Rights Offering. The Warrant provides for weighted average anti-dilution protection and is exercisable in whole or in part for ten (10)(10) years from the date of issuance. The per share subscription price paid was $1.50 in connection with the Rights Offering; accordingly, the exercise price of the Warrant was set at $1.50 per share, and there were 2.7 million shares underlying the Warrant. Taking into account partial exercises of the Warrant, there were approximately 1.51.0 million shares underlying the Warrant as of June 30, 20202021.

 

The Company accounts 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. The Company classified the Warrant as a liability and reports the change in fair value in the statement of operations.

 

As of June 30, 20202021, the fair value of the Warrant was $7.8$5.3 million. The fair value of the liability-classified Warrant was calculated using the following assumptions: risk free interest rate of 0.41%0.90%; no0 dividend yield; an expected life of 6.175.17 years; and a volatility factor of 75%55%.

9

 

 

8. Debt

 

On March 13, 2020, the Company voluntarily prepaid the Loan Agreement (as defined below) in an approximate aggregate amount of $87.2 million.  The prepayment was made from restricted cash, including $80.0 million in respect of outstanding principal of the Term Loan, $4.0 million that was payable upon the repayment of the Loan Agreement, approximately $1.2 million of accrued interest, and a prepayment premium amount of approximately $1.9 million.  The prepayment was made upon the Company and the Lender agreeing to and entering into customary mutual releases reflecting that, subject to such prepayment in accordance with the terms of the Loan Agreement, all of the obligations under the Loan Agreement were released, discharged and satisfied in full.  Upon such prepayment and release, the Loan Agreement was terminated. For the six months ended June 30, 2020, the Company recognized approximately $5.0 million of a loss on the extinguishment of the Term Loan related to the remaining unamortized discount and the prepayment premium.

 

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 (the "Term Loan") (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. Amounts were held in the escrow account until the satisfaction of certain conditions including the closing of the Rights Offering 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”). Interest on the Term Loan was at a per annum rate equal to the Adjusted LIBOR rate plus 11.5%, subject to adjustments as set forth in the Loan Agreement. 

 

The Term Loan had a maturity date 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.

 

Through the three and one-half year anniversary ( May 17, 2020) of the Escrow Release Date, any prepayment of the Term Loan was subject to a make-whole provision in which interest payments related to the prepaid amount were due (subject to a discount of treasury rate plus 0.50%).  Upon repayment of the Term Loan, an additional $4.0 million payment was required.  Such payment had been accreting to the Term Loan balance since the Escrow Release Date.

In connection with the issuance of 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 was payable upon repayment of Term Loan principal. 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 were 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. 

10

 

9. Fair Value of Financial Instruments

 

The carrying value of cash equivalents, restricted cash, accounts receivable, 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 $7.8$5.3 million at June 30, 20202021.

 

There were no transfers between levels of the fair value hierarchy for the six months ended June 30, 20202021. As of June 30, 20202021 and December 31, 2019, 2020, the Company had approximately $41.9$0.1 million and $56.7$0.1 million, respectively, of cash equivalents classified as Level 1 financial instruments. There were no0 Level 2 financial instruments as of June 30, 20202021. As of December 31, 2019, the Company had approximately $5.6 million and $90.0 million of restricted cash equivalents classified as Level 1 and Level 2 financial instruments, respectively. 

 

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, 2019

 $6,116,882 

Increase in fair value of warrant liability

  1,635,652 

Exercise of warrants

   

Warrant liability at June 30, 2020

 $7,752,534 
  

Fair Value Measurements of Level 3 liability-classified warrant

 

Warrant liability at December 31, 2020

 $6,639,211 

Decrease in fair value of warrant liability

  (1,361,070)

Exercise of warrants

  0 

Warrant liability at June 30, 2021

 $5,278,141 

11

 

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 loss per share computation: 

 

 

Three Months Ended June 30,

  

Six Months Ended June 30,

  

Three Months Ended June 30,

  

Six Months Ended June 30,

 
 

2020

  

2019

  

2020

  

2019

  

2021

  

2020

  

2021

  

2020

 

Net income/(loss) for basic earnings per share

 $20,890,158  $(3,162,492) $11,992,629  $(1,532,715) $169,200  $20,890,158  $(642,905) $11,992,629 

Less: Change in fair value of warrants

     656,523      3,792,788 

Net income/(loss), adjusted for change in fair value of warrants for diluted earnings per share

 $20,890,158  $(3,819,015) $11,992,629  $(5,325,503)

Less: Change in fair value of warrants and cash-based RSUs

  428,128  0  1,346,929  0 

Net (loss)/income, adjusted for change in fair value of warrants for diluted earnings per share

 $(258,928) $20,890,158  $(1,989,834) $11,992,629 

Weighted-average shares

 80,340,695  80,986,524  80,790,400  80,950,124  75,810,641  80,340,695  76,281,211  80,790,400 

Effect of potential common shares

  176,168   1,128,137   169,412   1,179,477   849,413   176,168   847,762   169,412 

Weighted-average shares: diluted

  80,516,863   82,114,661   80,959,812   82,129,601   76,660,054   80,516,863   77,128,973   80,959,812 

Income/(loss) per share: basic

 $0.26  $(0.04) $0.15  $(0.02) $0.00  $0.26  $(0.01) $0.15 

Income/(loss) per share: diluted

 $0.26  $(0.05) $0.15  $(0.06)

(Loss)/income per share: diluted

 $(0.00) $0.26  $(0.03) $0.15 

 

For the three and six months ended June 30, 2020,, diluted shares outstanding include the dilutive effect of in-the-money options, unvested restricted stock and unreleased restricted stock units. The dilutive effect of 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. Warrants were presumed to be cash-settled and therefore excluded from the diluted earnings per share calculations for the three and six months ended June 30, 2020because the net effect of their inclusion, including the elimination of the impact in the operating results of the change in fair value of the warrants, would have been anti-dilutive. For the three and six months ended June 30, 2020,, the weighted average number of shares under the warrant excluded from the calculation of diluted earnings per share were 1,140,713 and 1,108,753, respectively.

 

For the three and six months ended June 30, 20192021, the Company incurred losses and as a result, the equity instruments listed below were excluded from the calculation of diluted earnings (loss) per share as the effect of the exercise, conversion or vesting of such instruments would have been anti-dilutive. The weighted average number of equity instruments excluded consists of:

 

  

Three Months Ended June 30,

  

Six Months Ended June 30,

 
  

2019

  

2019

 

Stock options

  352,015   364,444 

Stock-settled stock appreciation rights

     3,359 

Restricted stock units

  527,082   518,295 

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 reflected the weighted average maximum number of shares that could be issued.

  

Three Months Ended June 30,

  

Six Months Ended June 30,

 
  

2021

  

2021

 

Stock options

  123,667   154,617 

Restricted stock units (stock settled)

  166,683   165,309 

 

 

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.

 

Purchase Commitments

 

In the course of our business, the Company regularly enters into agreements with third party organizations to provide contract manufacturing services and research and development services. Under these agreements, the Company issues purchase orders, which obligate the Company to pay a specified price when agreed-upon services are performed. In connection with many CMO purchase orders, reimbursement by CMOs for inventory losses is limited. Commitments under the purchase orders do not exceed our planned commercial and research and development needs. As of June 30, 20202021, the Company had approximatelapproximaty $21.3 ely $15.4 million of purchase commitments.

commitments associated with manufacturing obligations.

 

12

 

 

12. Related Party Transactions

 

Board of Directors and Outside Counsel

A former member of the Company’s Board of Directors who did not stand for re-election at the Company's 2021 annual meeting of stockholders is a partner at a law firm used by the Company’sCompany. The Company did not incur any expenses related to services provided by the outside counsel. counsel during the three months ended June 30, 2021. During the three months ended June 30, 2020and 2019, the Company incurred expenses$0.2 million of $184,000 and $122,000, respectively,expenses related to services provided by the outside counsel. During the six months ended June 30, 20202021 and 20192020,, the Company incurred expenses of $303,000 and $235,000, respectively,$0.1 million and $0.3 million, respectively, related to services provided by the outside counsel. On June 30, 2020 the Company’sThe Company had 0 outstanding payables andor accrued expenses included an approximate $106,000 liability to the outside counsel.

Board of Directors-Consulting Agreement

On October 13, 2018, the Company, entered into a consulting agreement with Dr. Eric A. Rose, a member, and former Executive Chairman, of the Company’s Board of Directors. Under the agreement, the consulting services will include assisting the Company on expanded indications for TPOXX® and other business development opportunities as requested by the Company. The term of the agreement is for two years, with compensation for such services at an annual rate of $200,000. During the three months ended June 30, 2020, the Company incurred $50,000 related to services under this agreement. Duringperformed by the six months ended June 30, 2020, the Company incurred $100,000 related to services under this agreement. Asoutside counsel as of June 30, 20202021., the Company’s outstanding payables and accrued expenses included a $50,000 liability associated with this agreement.

 

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“HQ Lease”), pursuant to which the Company agreed to lease 3,200 square feet at 31 East 62nd Street, New York, New York. The Company is utilizing premises leased under the New HQ Lease as its new 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.

Under the Old HQ Sublease, the Company was obligated to pay fixed rent of approximately $60,000 per month until August 2018 and approximately $63,400 per month thereafter until the Old HQ Sublease expiration date of August 31, 2020. Additionally, the Company was obligated to pay certain operating expenses and taxes ("Additional Rent"), such Additional Rent being specified in the overlease between M&F and the landlord at 660 Madison Avenue (the "Old HQ Overlease").

Under the Replacement M&F Sublease, the subtenant’s rental obligations were excused for During the firstthree two (2) months of the lease term (“Rent Concession Period”). Thereafter, the subtenant was obligated to pay fixed rent of $36,996 per month for the firsttwelve (12) months, and is obligated to pay $37,831 per month for the next 12six months and $38,665 per month until the scheduled expiration of the Replacement M&F Sublease onended August 24, 2020. June 30, 2021In addition to fixed rent, the subtenant is also obligated to pay, pursuant to the Replacement M&F Sublease, a portion of the Additional Rent specified in the Old HQ Overlease.

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 totalpaid expenses associated with this lease of approximately $0.9$0.1 million combined in fixed rent and additional amounts payable under the New HQ Lease and a total of approximately $1.1$0.2 million, in Rent Discrepancy under the Old HQ Sublease Termination Agreement, for a cumulative total of $2.0 million. In contrast, fixed rent and estimated Additional Rent under the Old HQ Sublease, for the aforementioned time period, would have been a total of approximately $2.4 million if each of the New HQ Lease, Replacement M&F Sublease and Old HQ Sublease Termination Agreement had not been entered into by each of the parties thereto. Because amounts such as operating expenses and taxes may vary, the foregoing totals can only be estimated at this time and are subject to change.respectively.

 

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.

13

 

 

13. Income Taxes 

 

The Company’s provision for income taxes consists of federal and state taxes, as applicable, in amounts necessary to align the Company’s year-to-date tax provision with the effective rate that it expects to achieve for the full year. Each quarter the Company updates its estimate of the annual effective tax rate and records cumulative adjustments as necessary.

 

On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) was enacted in response to the COVID-19 pandemic.  Under ASC 740, the effects of changes in tax rates and laws are recognized in the period which the new legislation is enacted.  The CARES Act made various tax law changes including among other things (i) increased the limitation under IRC Section 163(j) for 2019 and 2020 to permit additional expensing of interest (ii) enacted a technical correction so that qualified improvement property can be immediately expensed under IRC Section 168(k) and (iii) made modifications to the federal net operating loss rules including permitting federal net operating losses incurred in 2018,2019, and 2020 to be carried back to the five preceding taxable years in order to generate a refund of previously paid income taxes (iv) enhanced recoverability of AMT tax credit carryforwards. As a result of the CARES Act, the Company recorded a discrete income tax benefit of approximately $19,000 related to a reduction in 2019 state and local taxes as a result of increased deductions and recorded a balance sheet reclassification to reflect an income tax receivable of $0.7 million related to the accelerated recoverability of AMT credit carryforwards with a corresponding reduction to the Company’s deferred tax assets.

For the three months ended June 30, 20202021 and 20192020, we incurred a pre-tax income/(loss)income of $27.2$0.5 million and ($4.3)$27.2 million, respectively, and a corresponding income tax (provision)/benefitprovision of ($6.3)$0.3 million and $1.1$6.3 million, respectively.

 

For the six months ended June 30, 20202021 and 20192020, we incurred a pre-tax income/(loss)/income of $15.6($0.6) million and ($2.1)$15.6 million, respectively, and a corresponding income tax (provision)/benefitprovision of ($3.6)$0.1 million and $0.6$3.6 million, respectively.

 

The effective tax rate for the three months ended June 30, 20202021 was 23.2%63.8% compared to 26.2% in23.2% for the three months ended June 30, 20192020. The effective tax rate for the three months ended June 30, 2020 and 20192021 differs from the U.S. statutory rate of 21% primarily as a result of state taxes, non-deductible executive compensation under IRCInternal Revenue Code Section 162(m) and a non-taxable adjustment for the fair market value of the Warrant. The effective tax rate also includes a discrete income tax provision of $0.2 million primarily related to the expiration of stock options.

 

The effective tax rate for the six months ended June 30, 20202021 was 23.2%(11.3)% compared to 28.6% in23.2% for the comparable prior period.six months ended June 30, 2020. The effective tax rate for the six months ended June 30, 2020 and 20192021 differs from the U.S. statutory rate of 21% primarily as a result of state taxes, non-deductible executive compensation under IRCInternal Revenue Code Section 162(m) and a non-taxable adjustment for the fair market value of the Warrant. The effective tax rate also includes a discrete income tax provision of $0.2 million primarily related to the expiration of stock options.

 

 

14. Equity

 

The tables below present changes in stockholders' equity for the three and six months ended June 30, 20202021 and 20192020.

 

 

Common Stock

  

Additional Paid-in

  

Accumulated

  

Other Comprehensive

  Total Stockholders'  

Common Stock

  

Additional Paid-in

  

Accumulated

  

Other Comprehensive

  Total Stockholders' 
 

Shares

  

Amount

  

Capital

  

Deficit

  

Income

  

Equity

  

Shares

 

Amount

 

Capital

 

Deficit

 

Income

 

Equity

 

Balances at March 31, 2020

  81,047,424  $8,105  $221,057,307  $(132,923,290) $  $88,142,122 

Balances at March 31, 2021

  76,240,439  $7,625  $225,211,481  $(102,534,239) $0  $122,684,867 
Net income        20,890,158    20,890,158     0  0  169,200  0  169,200 

Repurchase of common stock

 (2,548,681) (255)   (15,222,540)   (15,222,795) (956,022) (96) 0  (6,600,414) 0  (6,600,510)

Payment of common stock tendered for employee stock-based compensation tax obligations

            
Issuance of common stock upon vesting of RSUs 120,000  12 (12)     105,000  10 (10) 0 0 0 

Stock-based compensation

        323,533         323,533      0   467,405   0   0   467,405 

Balances at June 30, 2020

  78,618,743  $7,862  $221,380,828  $(127,255,672) $  $94,133,018 

Balances at June 30, 2021

  75,389,417  $7,539  $225,678,876  $(108,965,453) $0  $116,720,962 

 

  

Common Stock

  

Additional Paid-in

  

Accumulated

  

Other Comprehensive

  

Total Stockholders'

 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Income

  

Equity

 

Balances at December 31, 2019

  81,269,868  $8,127  $220,808,037  $(123,032,408) $  $97,783,756 

Net income

           11,992,629      11,992,629 

Repurchase of common stock

  (2,773,775)  (277)     (16,215,893)     (16,216,170)

Payment of common stock tendered for employee stock-based compensation tax obligations

  (1,892)     (9,746)        (9,746)

Issuance of common stock upon vesting of RSUs

  124,542   12   (12)        - 

Stock-based compensation

        582,549         582,549 

Balances at June 30, 2020

  78,618,743  $7,862  $221,380,828  $(127,255,672) $  $94,133,018 

 

  

Common Stock

  

Additional Paid-in

  

Accumulated

  

Other Comprehensive

  

Total Stockholders'

 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Income

  

Equity

 

Balances at December 31, 2020

  77,195,704  $7,720  $224,978,430  $(95,192,881) $0  $129,793,269 

Net loss

        0   (642,905)  0   (642,905)

Repurchase of common stock

  (1,913,927)  (191)  0   (13,129,667)  0   (13,129,858)

Payment of common stock tendered for employee stock-based compensation tax obligations

  (1,902)  0   (13,361)  0   0   (13,361)

Issuance of common stock upon vesting of RSUs

  109,542   10   (10)  0   0   0 

Stock-based compensation

     0   713,817   0   0   713,817 

Balances at June 30, 2021

  75,389,417  $7,539  $225,678,876  $(108,965,453) $0  $116,720,962 

14

 
  

Common Stock

  

Additional Paid-in

  

Accumulated

  

Other Comprehensive

  

Total Stockholders'

 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Income

  

Equity

 

Balances at March 31, 2019

  80,941,524  $8,094  $220,222,959  $(114,161,484) $  $106,069,569 

Net loss

           (3,162,492)     (3,162,492)

Issuance of common stock upon vesting of RSUs

  105,000   11   (11)         

Stock-based compensation

        547,390         547,390 

Balances at June 30, 2019

 $81,046,524  $8,105  $220,770,338  $(117,323,976) $  $103,454,467 
 
  

Common Stock

  

Additional Paid-in

  

Accumulated

  

Other Comprehensive

  

Total Stockholders'

 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Income

  

Equity

 

Balances at March 31, 2020

  81,047,424  $8,105  $221,057,307  $(132,923,290) $0  $88,142,122 

Net income

     0   0   20,890,158   0   20,890,158 

Repurchase of common stock

  (2,548,681)  (255)  0   (15,222,540)  0   (15,222,795)

Payment of common stock tendered for employee stock-based compensation tax obligations

  0   0   0   0   0   0 

Issuance of common stock upon vesting of RSUs

  120,000   12   (12)  0   0   0 

Stock-based compensation

     0   323,533   0   0   323,533 

Balances at June 30, 2020

  78,618,743  $7,862  $221,380,828  $(127,255,672) $0  $94,133,018 

 

  

Common Stock

  

Additional Paid-in

  

Accumulated

  

Other Comprehensive

  

Total Stockholders'

 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Income

  

Deficiency

 

Balances at December 31, 2018

  80,763,350  $8,076  $218,697,872  $(115,791,261) $  $102,914,687 

Net loss

           (1,532,715)     (1,532,715)

Issuance of common stock upon exercise of stock options

  9,769   1   (1)         

Issuance of common stock upon vesting of RSUs and exercise of stock-settled appreciation rights

  121,771   13   (13)         

Issuance of common stock upon exercise of warrants

  159,782   16   1,172,785         1,172,801 

Payment of common stock tendered for employee stock-based compensation tax obligations

  (8,148)  (1)  (56,589)        (56,590)

Stock-based compensation

        956,284         956,284 

Balances at June 30, 2019

  81,046,524  $8,105  $220,770,338  $(117,323,976) $  $103,454,467 
  

Common Stock

  

Additional Paid-in

  

Accumulated

  

Other Comprehensive

  

Total Stockholders'

 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Income

  

Equity

 

Balances at December 31, 2019

  81,269,868  $8,127  $220,808,037  $(123,032,408) $0  $97,783,756 

Net income

     0   0   11,992,629   0   11,992,629 

Repurchase of common stock

  (2,773,775)  (277)  0   (16,215,893)  0   (16,216,170)

Payment of common stock tendered for employee stock-based compensation tax obligations

  (1,892)  0   (9,746)  0   0   (9,746)

Issuance of common stock upon vesting of RSUs

  124,542   12   (12)  0   0   0 

Stock-based compensation

     0   582,549   0   0   582,549 

Balances at June 30, 2020

  78,618,743  $7,862  $221,380,828  $(127,255,672) $0  $94,133,018 

 

On March 5, 2020, the Company announced that the boardCompany's Board of directorsDirectors had authorized a share repurchase program under which the Company may repurchase, from time to time, up to an aggregate of $50 million of the Company's common stock through December 31, 2021.  The timing and actual number of shares repurchased will depend on a variety of factors, including: exercise of procurement options under government contracts; alternative opportunities for strategic uses of cash; the stock price of the Company’s common stock; market conditions; and other corporate liquidity requirements and priorities.  Repurchases under the program may be made from time to time at the Company’s discretion in open market transactions, through block trades, in privately negotiated transactions, and pursuant to any trading plan that may be adopted by the Company’s management in accordance with Rule 10b5-1 ofunder the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise. During the three and six months ended June 30, 20202021, the Company repurchased 2.5approximately 1.0 million and 2.81.9 million shares of common stock, respectively, for approximately $15.2$6.6 million, and $16.2$13.1 million, respectively.

See Note 16 regarding a New Repurchase Authorization.

15

 

 

15. Leases

 

The Company leases its Corvallis, Oregon, facilities and office space under an operating lease, which was signed on November 3, 2017 and commenced on January 1, 2018. The initial term of this lease was to expire on December 31, 2019 after which the Company hashad two successive renewal options; one for two years and the other for three years. In the second quarter of 2019, the Company exercised the first renewal option, which extended the lease expiration date to December 31, 2021.In the second quarter of 2021, the Company exercised the second renewal option, which extended the lease expiration date to December 31, 2024. In connection with exercise of the second renewal option, the Company recorded an increase to operating lease right-of-use assets and operating lease liabilities of approximately $0.7 million in the second quarter 2021.

 

On May 26, 2017 the Company and M&F entered into the HQ Lease, a ten-year office lease agreement, (the “New HQ Lease”), pursuant to which the Company agreed to lease 3,200 square feet in New York, New York. The Company is utilizing premises leased under the New HQ Lease as its corporate headquarters. The Company has no leases that qualify as finance leases.

 

Operating lease costs totaled $0.1 million and $0.1 million for the three months ended June 30, 20202021 and 20192020, respectively. Operating lease costs totaled $0.3 million and $0.3 million for the six months ended June 30, 20202021 and 20192020, respectively. Cash paid for amounts included in the measurement of lease liabilities from operating cash flows was $0.1$0.2 million and $0.1 million for the three months ended June 30, 20202021 and 20192020, respectively. Cash paid for amounts included in the measurement of lease liabilities from operating cash flows was $0.3 million and $0.3 million for the six months ended June 30, 20202021 and 20192020, respectively. As of June 30, 20202021, the weighted-average remaining lease term of the Company’s operating leases was 5.955.02 years while the weighted-average discount rate was 4.53%.

 

Future undiscounted cash flows under operating leases as of June 30, 20202021 are expected to be as follows:

 

 

2020

 $247,288 

2021

 600,362  $251,289 

2022

 368,467  627,731 

2023

 402,078  669,048 

2024

  404,258   678,627 

2025

 406,994 

Thereafter

  982,880   575,887 

Total undiscounted cash flows under leases

 3,005,333  3,209,576 

Less: Imputed interest

  (418,153)  (373,593)

Present value of lease liabilities

 $2,587,180  $2,835,983 

 

As of June 30, 20202021, approximately $2.2$2.4 million of the lease liability is included in Other liabilities on the condensed consolidated balance sheet with the current portion included in accrued expenses.

16. Subsequent Event

 

On August 2, 2021, the Company's Board of Directors authorized an additional share repurchase program ("New Repurchase Authorization") under which the Company may repurchase up to $50 million of the Company's common stock through December 31, 2023. Shares can be repurchased under the New Repurchase Authorization once the maximum amount allowed to be repurchased under the program authorized in March 2020 has been repurchased, or once such program has expired. Repurchases under the New Repurchase Authorization may be made from time to time at the Company's discretion in open market transactions, through block trades, in privately negotiated transactions and pursuant to any trading plan that may be adopted by the Company's management in accordance with Rule 10b5-1 under the Exchange Act or otherwise. The timing and actual number of shares repurchased will depend on a variety of factors, including: exercise of procurement options under government contracts; alternative opportunities for strategic uses of cash; the stock price of the Company’s common stock; market conditions; and other corporate liquidity requirements and priorities.

1516

 

 

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.10-Q and in the 2020 Form 10-K. In addition to historical information, the following discussion and other parts of this Quarterly Report contain forward-looking information that involves risks and uncertainties.SIGAs actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors. See the factors set forth under the heading Safe Harbor Statement at the end of this Item 2.

 

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.company. Our lead product, is an oral formulation of TPOXX® (“oral TPOXX®”), is an oral formulation 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. 

 

COVID-19 Pandemic

 

The COVID-19 pandemic has caused significant societal and economic disruption. Such disruption, and the associated risks and costs, are expected to continue for an indeterminate period of time. Given the uncertain future course of the COVID-19 pandemic, and the uncertain scale and scope of its future direct and indirect impact, the Company is continually reviewing business and financial risks related to the pandemic and seeking coordination with its government partners with respect to the performance of current and future government contracts. Additionally, the Company is continually coordinating with service providers and vendors, in particular CMOsContract Manufacturing Organizations that constitute our supply chain, with respect to review actions and risks caused by the COVID-19 pandemic.

 

As of the filing date of this document, the Company has not identified or been notified by government customers of impediments to the continued full performance of their government contracts. Additionally, the Company’s supply chain for the manufacture of TPOXX® has remained operational on current projects without material COVID-19 related disruption, to TPOXX®-related manufacture, and in the ordinary course of operations, the supply chain has secured, or is in the process of securing, sufficient raw materials and supplies to support the ultimate manufacture and product delivery of at least 363,000 courses of oral TPOXX® (number of courses specified in April 2020 option exercise under the 19C BARDA Contract).activities on current projects. With regard to day-to-day operations, the COVID-19 pandemic, and the secondary effects of the pandemic, has at times slowed the daily pace of execution of government contracts as well as new contract generation. For example, U.S. and foreign government staff overseeing SIGA contractshealth security preparedness has been involved directly or indirectly in the federal government’s responsegovernmental responses to the pandemic, which has diverted government staff time that would normally be directed toward contract matters involving SIGA. With respectThe Company expects to research and development activities, the Company does expectexperience delays, or slower-than-usual pace, in connection with certain research and development activities, such as those that involve clinical trials. The Company does not currently expect any pandemic-related delays in research and development activities to have a material adverse impact on the financial condition or annual financial results of the Company, or its long-term performance, but cannot give assurances as to the full extent of the impact at this time.

 

Overall, the COVID-19 pandemic has not adversely affected the liquidity position of the Company, nor is it currently expected to have a material adverse effect on the financial condition of the Company. Given that the pandemic has diverted foreign government staff time normally directed toward contract matters involving SIGA, the COVID-19 pandemic has and could continue to affect the timing of international contract awards for oral TPOXX®. Additionally, the pandemic could result in a slower pace of product deliveries if the pandemic results in shortages or delays in the receipt by the supply chain of raw materials or supplies. Otherwise, the pandemic is not currently expected to have a material adverse effect on the 2021 financial results of the Company. The pandemic has resulted in almost all of our employees working from home; however, the shift in location for employees has not had a material adverse impact on the day-to-day operations of the Company. If the general negative effect of the COVID-19 pandemic becomes more acute or is prolonged, including due to resurgences in infections or lack of vaccination, there could be potential risks to our business and cash flows.

 

BARDA Contracts-TPOXX®Lead Product-TPOXX®

 

19C 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 U.S. Strategic National Stockpile ("Strategic Stockpile"), and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of the intravenous (IV) formulation of TPOXX® ("(“IV TPOXX®"). Additionally, the contract includes funding from BARDA for advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, and procurement activities. As of June 30, 2020,2021, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $ 602.5$602.5 million of payments, of which approximately $ 51.7  million$51.7 million of payments are included within the base period of performance (five years as of five years,the award date of September 10, 2018), approximately $ 127.1$127.1 million of payments are related to exercised options and up to approximately $ 423.7$423.7 million of payments are currently specified as unexercised options. BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term, including during the base period of performance. On May 20, 2019, an option for the manufacture and delivery

The option modification did not change the overall total potential value of the 19C BARDA Contract, nor did it change the total amount to be paid in connection with the manufacture and delivery of oral TPOXX® courses.

The bas ebase period of performance specifies potential payments of approximately $ 51.7 $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® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund advanced development of IV TPOXX®; and payments of approximately $0.6 million for supportive procurement activities. As of June 30, 2020 ,2021, the Company had received or billed for $11.1 million for the successful delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS and $4.7$11.0 million for other base period activities. IV BDS is expected to be used for the manufacture of 20,000 courses of IV FDP. The $3.2 million received for the manufacture of IV BDS has been recorded as deferred revenue as of June 30, 20202021 and December 31, 2019;2020; such amount is expected to be recognized as revenue when IV TPOXX® TPOXX® containing such IV BDS is delivered to the Strategic Stockpile or placed in vendor-managed inventory.

The options that have been exercised to date provide for payments up to approximately $ 127.1$127.1 million. There are exercised options for the following activities: payments up to $ 11.2$11.2 million for the procurement of raw materials to be used in the manufacture of at least 363,070 courses of oral TPOXX®,; payments up to $ 101.3$101.3 million for the delivery of up to 363,070 courses of oral TPOXX®; and payments of up to $ 14.6$14.6 million for funding of post-marketing activities for oral TPOXX®. As of June 30, 2021, the Company has received the following payments in connection with exercised options: $ 11.2$112.5 million was received forin connection with the procurement of raw materials and such amount was initially recorded as deferred revenue, with $ 3.6 million of this amount being recognized as revenue due to the June deliverydeliveries made in 2020 of approximately 117,000363,000 courses of oral TPOXX® (the remaining $ 7.6 million of deferred revenue is expected to be recognized as revenue when additional courses of oral TPOXX®, containing raw materials for which the Company has been paid, are delivered to the Strategic Stockpile or placed in vendor-managed inventory); and $2.3$6.8 million has been received or billed for in connection with post-marketing activities for oral TPOXX®. In July, the Company received a $32.6 million payment for the June delivery of approximately 117,000 courses of oral TPOXX®; in the second quarter, 2020, $36.2 million of revenue was recognized in connection with this product delivery, of which $32.6 million relates to the amount invoiced for product delivery and acceptance, and $3.6 million relates to amounts that were previously received and recorded as deferred revenue.
16

 

Unexercised options specify potential payments up to approximately $ 423.7$423.7 million in total (if all such options are exercised). There are options for the following activities: payments of up to $ 337.7$337.7 million for the delivery of up to approximately 1,089,000 courses of oral TPOXX® to the Strategic Stockpile; payments of up to $ 76.8$76.8 million for the manufacture of up to 192,000 courses of IV FDP, of which up to $ 30.7 $30.7 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP; payments of up to approximately $3.6 millionmillion to fund post-marketing activities for IV TPOXX®; and payments of up to approximately $ 5.6$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 19C 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 as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to make independent exercise decisions.options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option). 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. For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 64,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP.

Research Agreements and Grants The Company estimates that sales of the IV formulation under this contract (under current terms), assuming the IV FDP Options were exercised, would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%.

 

Under the terms of this contract, exercise of procurement options is at the sole discretion of BARDA. The Company has an R&D programrequest for IV TPOXX®. This program is funded byproposal that preceded the award of the 19C BARDA Contract indicated that the expected purpose of the contract was to maintain the level of smallpox antiviral preparedness in the Strategic Stockpile. Based on prior product delivery activity, and current FDA-approved shelf life of oral TPOXX®, the Company estimates that approximately one million courses of smallpox antiviral treatment would need to be delivered to the U.S. Government between 2021 and 2023 in order to maintain stockpile levels of unexpired smallpox antiviral treatment during this period.     

2011 BARDA Contract

On May 13, 2011, the Company signed a separate development contract with BARDA ("IV Formulation R&D Contract")pursuant to which 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.

The IV Formulation R&D2011 BARDA Contract has a periodspecifies approximately $508.4 million of performance that terminates in February 2024. Aspayments, of which, as of June 30, 2020,2021, $459.8 million has been received by the IV Formulation R&D Contract providesCompany for the manufacture and delivery of 1.7 million courses of oral TPOXX® and $45.8 million has been received for certain reimbursements in connection with development and supportive activities. Approximately $2.8 million remains eligible to be received in the future aggregate researchfor reimbursements of development and development funding of approximately $2.2 million. See Note 3 to the condensed consolidated financial statements regarding the 19C BARDA Contract.supportive activities.

 

In July 2019,The 2011 BARDA Contract expires in December 2024.

International Procurement Contracts

Contract with Public Health Agency of Canada

On January 13, 2021, the Company wasPublic Health Agency of Canada ("PHAC") awarded a multi-year research contract valued atto Meridian Medical Technologies, Inc. (“Meridian,"total of $19.5 million, with initial available funding of $12.4 million, fromPfizer Company) (the “Contract”) for the United States Department of Defense ("DoD") to support work in pursuit of a potential label expansion for oral TPOXX® that would include post-exposure prophylaxis ("PEP") of smallpox (such work known as the "PEP Label Expansion Program" and the contract referred to as the "PEP Label Expansion R&D Contract"). In May 2020, the DoD increased the scope and the contract value to a total of $26 million with current available funding of $23 million. As of June 30, 2020, the PEP Label Expansion R&D Contract provides for future aggregate research and development funding under the award, as modified,purchase of up to approximately $22.6 million.$33 million of oral TPOXX® (tecovirimat) within five years. The periodContract specifies firm commitments for the cumulative purchase of performanceapproximately $17 million of oral TPOXX® by March 31, 2023; the remaining courses under the Contract are targeted for thisdelivery after March 31, 2023 and are subject to option exercise by PHAC. For the three and six months ended June 30, 2021, SIGA recognized $6.9 million and $10.3 million of revenue, respectively, for the delivery of oral TPOXX® to PHAC. The contract as modified, terminatesaward was coordinated between SIGA and Meridian under an international promotion agreement (as amended, the "International Promotion Agreement") that was entered into by the parties on July 31, 2025.June 3, 2019. As such, Meridian is the PHAC's counterparty under the Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder. 

 

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

International Promotion of Oral TPOXX®Canadian Military Contract

 

On April 3, 2020, the Company announced that the Canadian Department of National Defence (the “CDND”(“CDND”) awarded a contract (the "Canadian Military Contract") to Meridian, Medical Technologies, Inc., a Pfizer Company ("Meridian"), pursuant to which the CDND will purchase up to 15,325 coursesapproximately $14 million of oral TPOXX® over four years for total potential payments of $14.3 million.years. In the second quarter 2020, CDND purchased 2,500 courses for $2.3 million.million of oral TPOXX®.  The remaining purchases are at the option of the CDND, and are expected to primarily occur after regulatory approval of oral TPOXX® in Canada. Meridian is the CDND's counterparty under the Canadian Military Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder. The contract award was coordinated between SIGA and MeridianFor the six months ended June 30, 2021, there were no deliveries under the international promotion agreement (the "Internationalthis contract.

International Promotion Agreement") that was entered into by the parties on June 3, 2019.Agreement

 

Under the terms of the International Promotion Agreement, Meridian was granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States and South Korea (the “Territory”), and Meridian has agreed not to commercialize any competing product, as defined in the International Promotion Agreement, in the specified field of use in the Territory. SIGA will retainretains ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States and South Korean markets, willmarket, also retainretains sales and marketing rights with respect to oral TPOXX®. SIGA’s consent shall beis required for the entry into any sales arrangement pursuant to the International Promotion Agreement.

 

The fee Meridian retains pursuant to the International Promotion Agreement will beis a specified percentage of the collected proceeds of sales of oral TPOXX® net of certain expenses, for years in which customer invoiced amounts net of such expenses are less than or equal to a specified threshold, and a higher specified percentage of such collected net proceeds for years in which such net invoiced amounts exceed the specified threshold.  Taking into account Meridian’s fee and manufacturing costs of oral TPOXX®, it is currently estimated by the Company that international sales of oral TPOXX® will have a contribution margin (as expressed as a percentage of product sales, and before any consideration of expenses not directly related to manufacturing or Meridian activities) of between approximately 65% and 80%.

 

1719


TPOXX Regulatory Summary

On July 13, 2018, the FDA approved oral TPOXX® for the treatment of smallpox.

For IV TPOXX®, SIGA filed a new drug application ("NDA") with the FDA for IV TPOXX® on April 30, 2021. Based on its review of the NDA, the FDA will decide whether to approve IV TPOXX® and whether to impose any marketing restrictions or require additional post-approval clinical studies. This review process will typically take ten months. There can be no assurance that any approval will be granted on a timely basis, if at all.

The Company is also seeking regulatory approval of oral TPOXX® in Europe and Canada. In July 2020, the Company filed a Marketing Authorisation Application ("MAA") with the European Medicines Agency ("EMA") for oral tecovirimat, the same formulation that was approved by the FDA in July 2018 under the name TPOXX®.  The MAA was filed under the centralized application process, which, upon approval, will enable sales and marketing of oral tecovirimat in all EU member states, as well as Norway, Iceland, and Liechtenstein.  SIGA has filed its application for oral tecovirimat seeking a broader label indication covering the treatment of smallpox, monkeypox, cowpox, and complications from Vaccinia infection.  In December 2020, the Company filed an application for marketing authorization in Canada for oral tecovirimat. Based on a typical regulatory review timeline, SIGA currently estimates that the review processes for oral TPOXX® in both Europe and Canada will be completed by the first quarter of 2022. There can be no assurance that any approval will be granted on a timely basis, if at all.

 

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 appears in Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations of our Annual Report on2020 Form 10-K for the year ended December 31, 2019 as filed on March 5, 2020.10-K. Our most critical accounting estimates include revenue recognition over time, the valuation of stock-based awards including options and warrants granted or issued by the Company and income taxes.

 

Results of Operations

 

Three Months Ended June 30, 20202021 and 20192020

 

For the three months ended June 30, 2021, revenues from product sales and supportive services were $6.9 million, which relate to the acceptance of courses of oral TPOXX® delivered to PHAC. For the three months ended June 30, 2020, revenues from product sales and supportive services were $38.6 million, of which $36.2 million relatesrelated to the delivery and acceptance of approximately 117,000 courses of oral TPOXX® to the Strategic Stockpile under the 19C BARDA Contract and $2.3 million relatesrelated to the delivery and acceptance of 2,500 courses of oral TPOXX® to the CDND. There were no product deliveries for the three months ended June 30, 2019.

 

Revenues from research and development activities for the three months ended June 30, 20202021 and 2019,2020, were $1.7 million and $3.9$1.7 million, respectively. TheAn increase of $0.5 million of revenue in connection with the PEP Label Expansion R&D Contract was offset by a decrease of $0.5 million in revenue of approximately $2.2 million, or 56%, primarily reflects the impact of a cumulative catch-up adjustment recognized during the three months ended June 30, 2019. During the three months ended June 30, 2019, the Company completed its negotiation with representatives of the U.S. government for a change in the application of certain reimbursement rates in the contract. The change in the application of those reimbursement rates increased the overall transaction price of the IV Formulation R&D Contract but did not change the estimate of costs to complete under the input method calculation.  As a result, the Company accounted for this as a change in the transaction price and recognized a cumulative catch-up adjustment to revenue of approximately $3.3 million representing the impact of the change in the application of those reimbursement rates from January 2016 through March 2019. This decrease was partially offset by an increase of $1.0 million in revenues from our federal contracts supporting the development of oral TPOXX® and IV TPOXX® because the scope of development activities related to both products has increased. 19C BARDA Contract.

 

Cost of sales and supportive services for the three months ended June 30, 2021 and 2020 were $1.0 million and $4.8 million, respectively. Such costs in 2021 were associated with the manufacture and there were no such expenses for the three months ended June 30, 2019.delivery of courses of oral TPOXX® to PHAC as well as an inventory-related loss of $0.6 million. Such costs in 2020 were mostly associated with the delivery and acceptance of approximately 119,000 courses of oral TPOXX®. There were no product deliveries for to the three months ended June 30, 2019.Strategic Stockpile.

 

Selling, general and administrative (“SG&A”) expenses for the three months ended June 30, 2021 and 2020 and 2019 were $3.9$5.2 million and $3.4$3.9 million, respectively. The increase of approximately $0.5$1.3 million or 14%35% primarily reflects the commission expense associatedpromotion fees paid in connection with the sale of oral TPOXX®courses delivered to the CDNDPHAC in May 2020.April 2021, as well as an increase in certain insurance, consulting, and professional service costs.

 

Research and development (“R&D”) expenses for the three months ended June 30, 2021 and 2020 and 2019 were $2.7$2.3 million and $2.0$2.7 million, respectively, reflecting an increasea decrease of approximately $0.7$0.4 million, or 33%16%. The increasedecrease is primarily attributable to an increasea decrease in direct vendor-related expenses incurred under the BARDA 19C Contract in connection with supporting the development of oralIV TPOXX® and IVthe performance of post-marketing regulatory activities for oral TPOXX®.

 

1820


 

Patent expenses were $0.2 million and $0.2 million for the three months ended June 30, 20202021 and 2019,2020, respectively. These expenses reflect our ongoing efforts to protect our lead drug candidates in various geographic territories.

Interest expense for the three months ended June 30, 2019 was $4.0 million. The $4.0 million of interest for the three months ended June 30, 2019 includes $1.1 million of accretion of unamortized costs and fees related to the Term Loan balance. There was no interest expense recognized for the three months ended June 30, 2020.

 

Changes in the fair value of the liability-classified warrant to acquire common stock were recorded within the income statement. For the three months ended June 30, 2021, we recorded a gain of approximately $0.4 million, reflecting a decrease in the fair value of the liability-classified warrant primarily due to the decrease in our stock price. For the three months ended June 30, 2020, we recorded a loss of approximately $1.6 million, reflecting an increase in the fair value of the liability-classified warrant primarily due to the increase in our stock price. For the three months ended June 30, 2019, we recorded a gain of approximately $0.7 million reflecting a decrease in the fair value of the liability-classified warrant primarily due to the decrease in our stock price. 

 

There was minimal other income for the three months ended June 30, 2020. Other income of $0.7 million for the three months ended June 30, 2019 reflects interest income on the Company's cash2021 and cash equivalent balances held in restricted and unrestricted accounts.2020.

 

For the three months ended June 30, 20202021 and 2019,2020, we incurred pre-tax income/(loss)income of $27.2$0.5 million and ($4.3)$27.2 million, respectively, and a corresponding income tax (provision) benefitprovision of ($6.3)$0.3 million and $1.1$6.3 million, respectively. The effective tax raterates during the three months ended June 30, 2021 and 2020 were 63.8% and 2019 was 23.2% and 26.2%, respectively. Our effective tax rate for the periodsthree months ended June 30, 2020 and 20192021 differs from the statutory rate primarily as a result of state taxes, non-deductible executive compensation under IRCInternal Revenue Code Section 162(m) and a non-taxable adjustment for the fair market value of the Warrant. The effective tax rate also includes a discrete income tax provision of $0.2 million primarily related to the expiration of stock options.

 

Six Months Ended June 30, 20202021 and 20192020

 

For the six months ended June 30, 20202021 and 2019,2020, revenues from product sales and supportive services were $10.4 million and $38.7 million, respectively. Such revenues in 2021 primarily relate to the delivery and $7.1 million, respectively.acceptance of courses of oral TPOXX® delivered to PHAC. Such revenues in 2020 include $36.2 million of revenue related to the delivery and acceptance of approximately 117,000 courses of oral TPOXX® to the Strategic Stockpile under the 19C BARDA Contract and $2.3 million of revenue related to the delivery and acceptance of 2,500 courses of oral TPOXX® to the CDND. Such revenues in 2019 were associated with the delivery of approximately 23,000 courses of oral TPOXX® to the Strategic Stockpile under the 19C BARDA Contract. 

 

Revenues from research and development activities for the six months ended June 30, 2021 and 2020, were $3.0 million and 2019, were $4.2 million, and $7.2 million, respectively. The net decrease in revenue of approximately $3.0$1.2 million, or 41%29%, primarily reflects the impact of a cumulative catch-up adjustment recognized during the six months ended June 30, 2019. During the six months ended June 30, 2019, the Company completed its negotiation with representatives of the U.S. government for a change in the application of certain reimbursement rates in the contract.  The change in the application of those reimbursement rates increased the overall transaction price of the IV Formulation R&D Contract but did not change the estimate of costs to complete under the input method calculation.  As a result, the Company accounted for this as a change in the transaction price and recognized a cumulative catch-up adjustment to revenue of approximately $3.3 million representing the impact of the change in the application of those reimbursement rates from January 2016 through March 2019. Additionally, the net decrease in revenues from research and development activities reflects a $1.0 million revenue decrease in connection with a decrease in direct vendor-related costs for IV TPOXX® activity. These decreases were partially offset by a revenue increase of approximately $1.3 million associated with oral TPOXX®. Revenue in connection with the development of oral TPOXX® has increased because the scope of development activities related to oral TPOXX® has increased.

 

Cost of sales and supportive services for the six months ended June 30, 2021 and 2020 and 2019, were $4.9$1.2 million and $0.9$4.9 million, respectively. Such costs in 2021 were associated with the manufacture and delivery of courses of oral TPOXX® to PHAC as well as an inventory-related loss of $0.6 million. Such costs in 2020 and 2019 were mostly associated with the delivery and acceptance of approximately 119,000 and 23,000 courses of oral TPOXX®, respectively. to the Strategic Stockpile.

 

Selling, general and administrative (“SG&A”) expenses for the six months ended June 30, 2021 and 2020 and 2019, were $7.0$9.3 million and $6.6$7.0 million, respectively. The increase of approximately $0.4$2.3 million or 7%32% primarily reflects the commission expense associatedpromotion fees paid in connection with the sale of oral TPOXX®courses delivered to the CDNDPHAC in May 2020.April 2021, as well as an increase in certain insurance and consulting costs.

 

Research and development (“R&D”) expenses for the six months ended June 30, 2021 and 2020 and 2019 were $5.9$4.6 million and $6.0$5.9 million, respectively, reflecting a decrease of approximately $0.1$1.3 million, or 3%22%. The net decrease is primarily attributable to a decrease in direct vendor-related expenses incurred under the BARDA 19C Contract in connection with supporting the development of IV TPOXX® partially offset by an increase in direct vendor-related expenses supportingand the developmentperformance of post-marketing regulatory activities for oral TPOXX®.

 

1921


 

Patent expenses were $0.4 million and $0.4 million, respectively, for the six months ended June 30, 20202021 and 2019.2020. These expenses reflect our ongoing efforts to protect our lead drug candidates in various geographic territories.

 

In connection with the voluntary repayment of the Term Loan on March 13, 2020, we recognized a loss on the extinguishment of the Term Loan of approximately $5.0 million for the six months ended June 30, 2020.

Interest expense for the six months ended June 30, 2020 and 2019 was $3.0 million and $7.9 million, respectively.million. The $3.0 million of interest for the six months ended June 30, 2020 includesincluded $0.9 million of accretion of unamortized costs and fees (prior to repayment of the Term Loan). The $7.9 million ofThere was no interest expense recognized for the six months ended June 30, 2019 includes $2.2 million of accretion of unamortized costs and fees related to the2021 as our Term Loan balance.was paid off in March 2020.

 

Changes in the fair value of the liability-classified warrant to acquire common stock were recorded within the income statement. For the six months ended June 30, 2021, we recorded a gain of approximately $1.4 million, reflecting a decrease in the fair value of the liability-classified warrant primarily due to the decrease in our stock price. For the six months ended June 30, 2020, we recorded a loss of approximately $1.6 million, reflecting an increase in fair value of the liability-classified warrant primarily due to the increase in our stock price. For the six months ended June 30, 2019, we recorded a gain of approximately $3.8 million reflecting a decrease in the fair value of the liability-classified warrant primarily due to the decrease in our stock price. 

 

Other income of $0.4less than $0.1 million and $1.5approximately $0.4 million for the six months ended June 30, 20202021 and 2019,2020, respectively, reflects interest income on the Company's cash and cash equivalent balances held in restricted and unrestricted accounts.

 

For the six months ended June 30, 20202021 and 2019,2020, we incurred pre-tax income/(loss)/income of $15.6($0.6) million and ($2.1)$15.6 million, respectively, and a corresponding income tax (provision) benefitprovision of ($3.6)$0.1 million and $0.6$3.6 million, respectively. The effective tax raterates during the six months ended June 30, 2021 and 2020 were (11.3)% and 2019 was 23.2% and 28.6%, respectively. Our effective tax rate for the periodssix months ended June 30, 2020 and 20192021 differs from the statutory rate primarily as a result of state taxes, non-deductible executive compensation under IRCInternal Revenue Code Section 162(m) and a non-taxable adjustment for the fair market value of the Warrant. The effective tax rate also includes a discrete income tax provision of $0.2 million primarily related to the expiration of stock options.

 

Liquidity and Capital Resources

 

As of June 30, 2020,2021, we had $53.1$98.5 million in cash and cash equivalents compared with $65.2$117.9 million at December 31, 2019. Additionally, in comparison to $95.7 million of restricted cash at December 31, 2019, there was no restricted cash as of June 30, 2020 given that the Term Loan was repaid in March 2020. The restricted cash was available to pay interest, fees and principal related to the Term Loan. The Company voluntarily prepaid the Term Loan on March 13, 2020 in an approximately aggregate amount of $87.2 million, including accrued interest. Upon repayment of the Term Loan, there are no restrictions on the use of our cash and cash equivalents.

 

Operating Activities

We prepare our condensed consolidated statement of cash flows using the indirect method. Under this method, we reconcile net income income/(loss) to cash flows from operating activities by adjusting net income/(loss) income for those items that impact net income income/(loss) but may not result in actual cash receipts or payments during the period. These reconciling items include but are not limited to stock-based compensation, loss on the extinguishment of the Term Loan, deferred income taxes, non-cash interest expense and changes in the fair value of our warrant liability, inventory write offs, gains and losses from various transactions and changes in the condensed consolidated balance sheet for working capital from the beginning to the end of the period.

 

Net cash used in operating activities for the six months ended June 30, 2021 and 2020 and 2019 was $5.8$6.2 million and $4.3$5.8 million, respectively. For the six months ended June 30, 2021 and 2020 net cash usage was primarily relatedrelates to customary operating activities. For the six months ended June 30, 2019, we incurred $5.7 million of cash interest expense on the Term Loan and used approximately $1.8 million in support of ordinary course working capital (accounts receivable, accounts payable, and prepaids, among other items). Additionally, cash was used for and customary operating activities. These cash uses were partially offset by the receipt of approximately $7.1 million from BARDA for product delivery.activity. 

 

Investing Activities

For the six months ended June 30, 20202021 and 2019,2020, we used cash in the amounts of $15,501$24,424 and $8,948,$15,501, respectively, for capital expenditures.

 

Financing Activities

Net cash used in financing activities for the six months ended June 30, 2021 was $13.1 million, which was substantially all attributable to our repurchase of approximately 1.9 million shares of common stock. Net cash used by financing activities for the six months ended June 30, 2020 was $102.1 million, which was attributable to our voluntary prepayment of the Term Loan, of which approximately $85.9 million iswas recorded as a financing activity, and our repurchase of approximately 2.8 million shares of common stock for approximately $16.2 million. Net cash used by financing activities for the six months ended

Future Cash Requirements

As of June 30, 2019 was $56,590, which is attributable to2021, we had outstanding purchase orders associated with manufacturing obligations in the paymentaggregate amount of tax obligations for employee common stock tendered. approximately $15.4 million.

 

Off-Balance Sheet Arrangements

 

The Company does not have any off-balance sheet arrangements.

 

2022


 

Recently Issued Accounting Standards

 

For discussion regarding the impact of accounting standards that were recently issued but not yet effective,adopted on the Company's condensed consolidated financial statements, as well as those standards that were adopted, see Note 2, Summary of Significant Accounting Policies, 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 the foregoing “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, delivering products to the U.S. Strategic National Stockpile and the enforceability of the 2011 BARDA Contract and the 19C BARDA Contract (each as defined previously, and collectively, the "BARDA Contracts") with BARDA. 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 SIGAherein 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 all, or any, of the remaining unexercised options under 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 potential alternative uses or formulations of TPOXX® that appear promising to SIGA or its collaborators, 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 the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xi) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiii) the risk that the COVID-19 pandemic could impact SIGA’s operations by disrupting SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts and (xiv) the risk that the U.S. government’sor foreign governments' responses (including inaction) to the national or global economic situationconditions or infectious disease such as COVID-19 are ineffective and may affect SIGA’s business adversely, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019.2020 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov. 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, 2019, 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 and changes in the financial standing of the issuerissuers of such securities and our interest income is sensitive to changes in the general level of U.S. interest rates. Additionally, we are subject to the impact of stock price fluctuations of our common stock in that we have a liability-classified warrant in which 1.51.0 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 $1.5$1.0 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 June 30, 2020.2021. The term “disclosure controls and procedures” is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934.Act. 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 June 30, 2020 at a reasonable level of assurance.2021.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting during the quarter ended June 30, 20202021 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, including collections claims, breach of contract claims, labor and employment claims, tax related matters 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, or 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 20192020 Annual Report on Form 10-K for the fiscal year ended December 31, 2019.2020. There have been no material changes to the risk factors described in Part I, Item 1A "Risk Factors" of our 2020 Form 10-K.

 

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

 

ISSUER PURCHASES OF EQUITY SECURITIES

 

Period

 

Total Number of Shares Purchased

  

Average Price Paid per Share

  

Total Number of Shares Purchased as Part of Publicly Announced Program

  

Dollar Value of Shares That May Yet Be Purchased Under the Program

 

April 1, 2020 to April 30, 2020

  -  $-   -  $- 

May 1, 2020 to May 31, 2020

  892,100   5.88   892,100   43,759,603 

June 1, 2020 to June 30, 2020

  1,656,581   6.02   1,656,581   33,783,829 
   2,548,681  $5.97   2,548,681     

Period

 

Total Number of Shares Purchased

  

Average Price Paid per Share

  

Total Number of Shares Purchased as Part of Publicly Announced Program

  

Dollar Value of Shares That May Yet Be Purchased Under the Program

 

April 1, 2021 to April 30, 2021

  297,461  $7.15   297,461  $12,840,289 

May 1, 2021 to May 31, 2021

  289,588   7.10   289,588   10,785,234 

June 1, 2021 to June 30, 2021

  368,973   6.55   368,973   8,367,196 
   956,022  $6.90   956,022     

 

On March 5, 2020, the Company announced that the Board of Directors had authorized a share repurchase program under which the Company may repurchase, from time to time, up to an aggregate of $50 million of the Company’s common stock through December 31, 2021. The timing and actual number of shares repurchased will depend on a variety of factors, including: exercise of procurement options under government contracts; alternative opportunities for strategic uses of cash; the stock price of the Company’s common stock; market conditions; and other corporate liquidity requirements and priorities. Prior

See Note 16, Subsequent Event, of Notes to executing any repurchases under this program, the Company’s current term loan needed to be fully repaid or its terms needed to be amended to allowCondensed Consolidated Financial Statements, for share repurchases. information regarding a New Repurchase Authorization.

 

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.

 

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Item 6. Exhibits

 

Exhibit No.

Description

3.1Amended and Restated Certificate of Incorporation of SIGA Technologies, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company filed on April 14, 2016).
3.2Amended and Restated Bylaws of SIGA Technologies, Inc. (incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K of the Company filed on April 14, 2016). 
3.3Amendment to Amended and Restated Bylaws of SIGA Technologies, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company filed on December 13, 2016). 
10.1Amendment of Solicitation/Modification of Contract 0005, dated April 29, 2020, to Agreement, dated September 10, 2018 by and between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (certain portions of this exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted information is (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed).

31.1

Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1

Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2

Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS

Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)

101.SCH

Inline XBRL Taxonomy Extension Schema

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase

104Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101).

 

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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:

August 6, 20205, 2021

By:

/s/ Daniel J. Luckshire

 

 

 

 

Daniel J. Luckshire

 

 

 

 

Executive Vice President and Chief Financial Officer

 

 

 

(Duly Authorized Officer, Principal Financial Officer and Principal Accounting Officer)

 

 

 

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