siga20200331_10q.htm
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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 September 30, 2020

 

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 October 23, 2020, the registrant had outstanding 77,399,505 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

16

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

21

Item 4.

Controls and Procedures

21

 

 

 

PART II- OTHER INFORMATION

Item 1.

Legal Proceedings

22

Item 1A

Risk Factors

22

Item 2.

Unregistered Sale of Equity Securities and Use of Proceeds

22

Item 3.

Defaults upon Senior Securities

22

Item 4.

Mine Safety Disclosures

22

Item 5.

Other Information

22

Item 6.

Exhibits

23

SIGNATURES

 

24

 

 

 

 

PART I - FINANCIAL INFORMATION

Item 1 - Condensed Consolidated Financial Statements 

SIGA TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

 

  

September 30, 2020

  

December 31, 2019

 

ASSETS

        

Current assets

        

Cash and cash equivalents

 $78,663,526  $65,249,072 

Restricted cash and cash equivalents, short-term

  -   95,737,862 

Accounts receivable

  40,398,708   4,167,996 

Inventory

  10,747,532   9,652,855 

Prepaid expenses and other current assets

  1,290,388   5,234,000 

Total current assets

  131,100,154   180,041,785 
         

Property, plant and equipment, net

  2,236,668   2,618,303 

Deferred tax assets, net

  6,484,111   14,151,002 

Goodwill

  898,334   898,334 

Other assets

  702,885   856,766 

Total assets

 $141,422,152  $198,566,190 

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities

        

Accounts payable

 $1,118,307  $3,054,032 

Accrued expenses and other current liabilities

  15,182,437   8,636,911 
Total debt, current  -   80,044,866 

Total current liabilities

  16,300,744   91,735,809 

Warrant liability

  9,026,690   6,116,882 

Other liabilities

  3,134,304   2,929,743 

Total liabilities

  28,461,738   100,782,434 

Commitments and contingencies

          

Stockholders’ equity

        

Common stock ($.0001 par value, 600,000,000 shares authorized, 77,770,284 and 81,269,868, issued and outstanding at September 30, 2020 and December 31, 2019, respectively)

  7,777   8,127 

Additional paid-in capital

  221,587,384   220,808,037 

Accumulated deficit

  (108,634,747)  (123,032,408)

Total stockholders’ equity

  112,960,414   97,783,756 

Total liabilities and stockholders’ equity

 $141,422,152  $198,566,190 

 

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

 

 

 

SIGA TECHNOLOGIES, INC.

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

 

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2020

  

2019

  

2020

  

2019

 

Revenues

                

Product sales and supportive services

 $41,810,192  $3,915,335  $80,547,651  $11,057,735 

Research and development

  2,451,215   4,195,989   6,682,298   11,420,284 

Total revenues

  44,261,407   8,111,324   87,229,949   22,478,019 
                 

Operating expenses

                

Cost of sales and supportive services

  5,559,215   737,274   10,465,078   1,652,641 

Selling, general and administrative

  3,566,258   3,196,370   10,613,267   9,755,165 

Research and development

  2,073,613   3,343,521   7,933,404   9,379,125 

Patent expenses

  164,102   173,580   520,902   543,806 

Total operating expenses

  11,363,188   7,450,745   29,532,651   21,330,737 

Operating income

  32,898,219   660,579   57,697,298   1,147,282 

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

  (1,274,156)  981,923   (2,909,808)  4,774,711 
Loss on extinguishment of Term Loan  -   -   (4,981,461)  - 

Interest expense

  -   (3,971,952)  (3,016,817)  (11,871,401)

Other income, net

  24,932   759,881   469,226   2,233,588 

Income (loss) before income taxes

  31,648,995   (1,569,569)  47,258,438   (3,715,820)

(Provision) benefit for income taxes

  (7,461,038)  363,742   (11,077,854)  977,278 

Net and comprehensive income (loss)

 $24,187,957  $(1,205,827) $36,180,584  $(2,738,542)

Basic income (loss) per share

 $0.31  $(0.01) $0.45  $(0.03)

Diluted income (loss) per share

 $0.31  $(0.03) $0.45  $(0.09)

Weighted average shares outstanding: basic

  78,080,461   81,064,927   79,880,493   80,988,813 

Weighted average shares outstanding: diluted

  78,168,070   82,181,858   80,051,778   82,148,333 

 

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

 

 

 

SIGA TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

 

  

Nine Months Ended September 30,

 
  

2020

  

2019

 

Cash flows from operating activities:

        

Net income/(loss)

 $36,180,584  $(2,738,542)

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

        

Depreciation and other amortization

  397,136   395,540 

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

  2,909,808   (4,774,711)

Stock-based compensation

  963,372   1,717,380 

Deferred income taxes, net

  7,666,891   (1,065,675)
Loss on extinguishment of Term Loan  4,981,461   - 

Non-cash interest expense

  887,132   3,363,712 

Changes in assets and liabilities:

        

Accounts receivable

  (36,230,712)  (1,258,568)

Inventory

  1,507,995   (1,022,951)

Prepaid expenses and other assets

  1,494,821   2,189,076 

Accounts payable, accrued expenses and other liabilities

  474,736   (697,325)

Deferred revenue

  4,339,626   (47,939)

Net cash provided by/(used in) operating activities

  25,572,850   (3,940,003)

Cash flows from investing activities:

        

Capital expenditures

  (15,501)  (29,092)

Net cash used in investing activities

  (15,501)  (29,092)

Cash flows from financing activities:

        

Payment of employee tax obligations for common stock tendered

  (184,009)  (199,810)
Repurchase of common stock  (21,783,289)  - 
Repayment of Term Loan  (85,913,459)  - 

Net cash used in financing activities

  (107,880,757)  (199,810)

Net decrease in cash, cash equivalents and restricted cash

  (82,323,408)  (4,168,905)

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

  160,986,934   180,396,910 

Cash, cash equivalents and restricted cash at end of period

 $78,663,526  $176,228,005 
         

Supplemental disclosure of non-cash activities:

        

Conversion of warrants to common stock

 $-  $1,172,801 

Issuance of common stock upon cashless exercise

 $-  $118,500 

 

The accompanying notes are an integral part of these financial statements

 

 

SIGA TECHNOLOGIES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

 

1. Condensed Consolidated Financial Statements

 

The financial statements are presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the rules and regulations of the Securities and Exchange Commission (the “SEC”) for quarterly reports on Form 10-Q and should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2019, included in the 2019 Annual Report on Form 10-K. All terms used but not defined elsewhere herein have the meaning ascribed to them in the Company’s 2019 Annual Report on Form 10-K filed on March 5, 2020. 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 2019 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 nine months ended September 30, 2020 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 September 30, 2020, 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 transaction price allocated to remaining performance obligations was $100.9 million as of September 30, 2020. 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  September 30, 2020, the accounts receivable balance in the condensed balance sheet includes approximately $2.5 million of unbilled receivables. 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 nine months ended September 30, 2020, the Company recognized revenue of $0.1 million 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

 
  

September 30, 2020

  

December 31, 2019

 

Cash and cash equivalents

 $78,663,526  $65,249,072 

Restricted cash-short term

     95,737,862 
Cash, cash equivalents and restricted cash $78,663,526  $160,986,934 

 

  

September 30, 2019

  

December 31, 2018

 

Cash and cash equivalents

 $78,095,231  $100,652,809 

Restricted cash-short term

  11,053,200   11,452,078 

Restricted cash-long term

  87,079,574   68,292,023 

Cash, cash equivalents and restricted cash

 $176,228,005  $180,396,910 

 

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 June 2016, the FASB issued ASU No. 2016- 13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments ("ASU 2016- 13"). ASU 2016- 13 requires an entity to measure and recognize expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity's current estimate of credit losses expected to be incurred. The standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted. The adoption of this standard had no impact on the 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 September 30, 2020, 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 September 30, 2020, the Company had received $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 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 September 30, 2020 and December 31, 2019; 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 September 30, 2020, the Company has received the following payments in connection with exercised options: $11.2 million was received for the procurement of raw materials and such amount was initially recorded as deferred revenue, with $7.7 million of this amount being recognized as revenue due to  June and September deliveries of approximately 251,000 courses, in the aggregate, of oral TPOXX® (the remaining $3.5 million of deferred revenue is expected to be recognized as revenue in the fourth quarter of 2020, in conjunction with the delivery to the Strategic Stockpile of approximately 112,000 courses of oral TPOXX®, which contain raw materials for which the Company has been paid); $32.6 million was received in connection with the June delivery of approximately 117,000 courses of oral TPOXX®; and $2.3 million has been received in connection with post-marketing activities for oral TPOXX®. In October 2020, the Company received payment of the $37.3 million account receivable for the September delivery of approximately 134,000 courses of oral TPOXX®. In the third quarter of 2020, $41.4 million of revenue was recognized in connection with this product delivery, of which $37.3 million relates to the amount invoiced for product delivery and acceptance, and $4.1 million relates to amounts that were previously received and recorded as deferred revenue, as such amounts were not previously delivered. During the nine months ended September 30, 2020, $77.7 million of revenue was recognized in connection with the June and September product deliveries, of which $69.9 million relates to the amounts invoiced for product delivery and acceptance, and $7.7 million relates to amounts that were previously received and recorded as deferred revenue, as deliveries containing such amounts of raw materials had not been made. In October, the Company delivered approximately 112,000 courses of oral TPOXX® to the Strategic Stockpile; revenue in conjunction with this product delivery will be included in the fourth quarter of 2020 financial results.

 

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 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 million to fund post-marketing activities for IV TPOXX®; and payments of up to approximately $5.6 million for supportive procurement activities.

 

The options related to IV TPOXX® are divided into two primary manufacturing steps. There are options related to the manufacture of bulk drug substance (“IV BDS Options”), and there are corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA may choose to exercise any, all, or none of these options in its sole discretion. The 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. 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.

 

6

 

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 for 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 September 30, 2020 and 2019, the Company recognized revenues of $1.8 million and $2.2 million, respectively, on an over time basis. For the nine months ended September 30, 2020 and 2019, the Company recognized revenues of $5.2 million and $4.0 million, respectively, on an over time basis. In contrast, revenue recognized for product delivery and therefore at a point in time for the three and nine months ended September 30, 2020 was $41.4 million and $77.7 million, respectively. For the three and nine months ended September 30, 2019, the Company recognized $3.9 million and $11.1 million of revenue, respectively, at a point in time.

 

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 September 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 $45.5 million has been received for certain reimbursements in connection with development and supportive activities. Approximately $3.1 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 December 2024.

 

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 September 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 nine months ended September 30, 2020 and 2019, the Company recognized revenue of $0.2 million and $0.3 million, respectively on an over time basis. For the three and nine months ended September 30, 2020, the Company recognized $0.3 million and $0.4 million, respectively, for product sales and supportive services. There was no revenue recognized for product delivery and therefore no revenue recognized at a point in time, for the three and nine months ended September 30, 2019.

 

International Procurement Contracts

On April 3, 2020, the Company announced that the Canadian Department of National Defence (the “CDND”) awarded a contract (the "Canadian Contract") to Meridian Medical Technologies, Inc., a Pfizer Company ("Meridian"), pursuant to which the CDND will purchase up to 15,325 courses of oral TPOXX® over four years for total potential payments of $14.3 million.  In the second quarter 2020, CDND purchased 2,500 courses for $2.3 million.  The remaining purchases are at the option of the CDND, and are expected to occur after regulatory approval of oral TPOXX® in Canada. Meridian is the CDND's counterparty under the Canadian Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder.  The contract award was coordinated between SIGA and Meridian under the international promotion agreement, 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 (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 market, will also retain sales and marketing rights with respect to oral TPOXX®. SIGA’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 nine months ended September 30, 2020, the Company recognized $2.3 million of revenue. There was no revenue recognized during the three months ended September 30, 2020

 

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 development contract with BARDA (“IV Formulation R&D Contract”). The IV Formulation R&D Contract has a period of performance that terminates in February 2024. As of September 30, 2020, the IV Formulation R&D Contract provides for future aggregate research and development funding of approximately $2.0 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. For the three months ended September 30, 2020 and 2019, the Company recognized revenue of $0.4 million and $1.7 million, respectively. For the nine months ended September 30, 2020 and 2019, the Company recognized revenue of $1.1 million and $7.1 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 initial available funding 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 of $26 million with current available funding of $23 million. As of September 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 $22.5 million. The period of performance for this contract, as modified, terminates on July 31, 2025. For the three and nine months ended September 30, 2020, the Company, under the PEP Label Expansion R&D Contract, recognized revenue of $0.2 million and $0.3 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, we 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

 
  

September 30, 2020

  

December 31, 2019

 
Raw materials $2,628,153  $- 

Work in-process

  1,657,374   8,693,457 

Finished goods

  6,462,005   959,398 

Inventory

 $10,747,532  $9,652,855 

 

 

5. Property, Plant and Equipment

 

Property, plant and equipment consisted of the following: 

 

  

As of

 
  

September 30, 2020

  

December 31, 2019

 

Leasehold improvements

 $2,420,028  $2,420,028 

Computer equipment

  617,298   601,797 

Furniture and fixtures

  377,859   377,859 

Operating lease right-of-use assets

  2,944,932   2,944,932 
   6,360,117   6,344,616 

Less - accumulated depreciation and amortization

  (4,123,449)  (3,726,313)

Property, plant and equipment, net

 $2,236,668  $2,618,303 

 

Depreciation and amortization expense on property, plant, and equipment was $397,136 and $395,540 for the nine months ended September 30, 2020 and 2019, respectively.

 

 

6. Accrued Expenses and Other Current Liabilities

 

Accrued expenses and other current liabilities consisted of the following:

 

  

As of

 
  

September 30, 2020

  

December 31, 2019

 

Deferred revenue

 $6,637,967  $2,298,341 
Income tax payable  3,705,395   7,093 

Compensation

  2,497,175   2,966,139 
Inventory  517,643   71,541 

Lease liability, current portion

  441,992   419,709 

Vacation

  423,205   256,402 

Other

  373,376   643,570 

Professional fees

  352,594   288,707 

Research and development vendor costs

  233,090   707,685 

Interest payable

  -   977,724 

Accrued expenses and other current liabilities

 $15,182,437  $8,636,911 

 

 

7. Financial Instruments

 

2016 Warrant

On September 2, 2016, in connection with the entry into the Loan Agreement (see Note 8 for additional information), the Company issued a warrant (the “Warrant”) to the Lender to purchase a number of shares of the Company’s common stock equal to $4.0 million divided by the lower of (i) $2.29 per share and (ii) the subscription price paid in connection with the Rights Offering. The Warrant provides for weighted average anti-dilution protection and is exercisable in whole or in part for ten (10) years from the date of issuance. The per share subscription price paid was $1.50 in connection with the 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 1.5 million shares underlying the Warrant as of September 30, 2020.

 

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 September 30, 2020, the fair value of the Warrant was $9.0 million. The fair value of the liability-classified Warrant was calculated using the following assumptions: risk free interest rate of 0.37%; no dividend yield; an expected life of 5.92 years; and a volatility factor of 70%.

 

9

 
 

8. Debt

 

On March 13, 2020, the Company voluntarily prepaid the Loan Agreement 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 nine months ended September 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 $9.0 million at September 30, 2020.

 

There were no transfers between levels of the fair value hierarchy for the nine months ended September 30, 2020. As of September 30, 2020 and December 31, 2019, the Company had approximately $42.0 million and $56.7 million, respectively, of cash equivalents classified as Level 1 financial instruments. There were no Level 2 financial instruments as of September 30, 2020. 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

  2,909,808 

Exercise of warrants

   

Warrant liability at September 30, 2020

 $9,026,690 

 

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 September 30,

  

Nine Months Ended September 30,

 
  

2020

  

2019

  

2020

  

2019

 

Net income/(loss) for basic earnings per share

 $24,187,957  $(1,205,827) $36,180,584  $(2,738,542)

Less: Change in fair value of warrants

     981,923      4,774,711 

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

 $24,187,957  $(2,187,750) $36,180,584  $(7,513,253)

Weighted-average shares

  78,080,461   81,064,927   79,880,493   80,988,813 

Effect of potential common shares

  87,609   1,116,931   171,285   1,159,520 

Weighted-average shares: diluted

  78,168,070   82,181,858   80,051,778   82,148,333 

Income/(loss) per share: basic

 $0.31  $(0.01) $0.45  $(0.03)

Income/(loss) per share: diluted

 $0.31  $(0.03) $0.45  $(0.09)

 

For the three and nine months ended September 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 nine months ended September 30, 2020 because 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 nine months ended September 30, 2020, the weighted average number of shares under the warrant excluded from the calculation of diluted earnings per share were 1,205,829 and 1,146,898, respectively.

 

For the three and nine months ended September 30, 2019, 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 September 30,

  

Nine Months Ended September 30,

 
  

2019

  

2019

 

Stock options

  332,861   353,801 

Stock-settled stock appreciation rights

     2,227 

Restricted stock units

  598,793   545,422 

 

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.

 

 

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. Commitments under the purchase orders do not exceed our planned commercial and research and development needs. As of September 30, 2020, the Company had approximately $31.3 million of purchase commitments.

 

12

 
 

12. Related Party Transactions

 

Board of Directors and Outside Counsel

A member of the Company’s Board of Directors is a partner at the Company’s outside counsel. During the three months ended September 30, 2020 and 2019, the Company incurred expenses of $91,000 and $117,000, respectively, related to services provided by the outside counsel.  During the nine months ended September 30, 2020 and 2019, the Company incurred expenses of $393,000 and $353,000, respectively, related to services provided by the outside counsel. On September 30, 2020 the Company’s outstanding payables and accrued expenses included an approximate $73,000 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 included assisting the Company on expanded indications for TPOXX® and other business development opportunities as requested by the Company. The term of the agreement expired on October 13, 2020 and the agreement has not been renewed. Compensation under the agreement was at an annual rate of $200,000. During the three months ended September 30, 2020, the Company incurred $50,000 related to services under this agreement. During the nine months ended September 30, 2020, the Company incurred $150,000 related to services under this agreement. As of September 30, 2020, 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 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. During the three and nine months ended September 30, 2020, the Company paid expenses associated with this lease of $0.1 million and $0.3 million, respectively.

 

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 in September, 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 the first 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 first twelve (12) months, and is obligated to pay $37,831 per month for the next 12 months, and $38,665 per month until the scheduled expiration of the Replacement M&F Sublease in September, 2020. In 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.

 

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 September 30, 2020 and 2019, we incurred a pre-tax income/(loss) of $31.6 million and ($1.6) million, respectively, and a corresponding income tax (provision)/benefit of ($7.5) million and $0.4 million, respectively.

 

For the nine months ended September 30, 2020 and 2019, we incurred pre-tax income/(loss) of $47.3 million and ($3.7) million, respectively, and a corresponding income tax (provision)/benefit of ($11.1) million and $1.0 million, respectively. 

 

The effective tax rate for the three months ended September 30, 2020 was 23.6% compared to 23.2% for the three months ended September 30, 2019. The effective tax rates for the three months ended September 30, 2020 and 2019 differ from the U.S. statutory rate of 21% primarily as a result of state taxes, non-deductible executive compensation under IRC Section 162(m) and a non-taxable adjustment for the fair market value of the Warrant.

 

The effective tax rate for the nine months ended September 30, 2020 was 23.4% compared to 26.3% in the comparable prior period. The effective tax rates for the nine months ended September 30, 2020 and 2019 differ from the U.S. statutory rate of 21% primarily as a result of state taxes, non-deductible executive compensation under IRC Section 162(m) and a non-taxable adjustment for the fair market value of the Warrant.

 

 

14. Equity

 

The tables below present changes in stockholders' equity for the three and nine months ended September 30, 2020 and 2019.

 

  

Common Stock

  

Additional Paid-in

  

Accumulated

  

Other Comprehensive

  Total Stockholders' 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Income

  

Equity

 

Balances at June 30, 2020

  78,618,743  $7,862  $221,380,828  $(127,255,672) $  $94,133,018 
Net income            24,187,957      24,187,957 

Repurchase of common stock

  (886,472)  (89)     (5,567,032)     (5,567,121)

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

  (27,143)  (3)  (174,260)        (174,263)
Issuance of common stock upon exercise of stock options  11,822   1   (1)           
Issuance of common stock upon vesting of RSUs  53,334   6   (6)         

Stock-based compensation

        380,823         380,823 

Balances at September 30, 2020

  77,770,284  $7,777  $221,587,384  $(108,634,747) $  $112,960,414 

 

  

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

           36,180,584      36,180,584 

Repurchase of common stock

  (3,660,247)  (366)     (21,782,923)     (21,783,289)

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

  (29,035)  (3)  (184,006)        (184,009)
Issuance of common stock upon exercise of stock options  11,822   1   (1)         

Issuance of common stock upon vesting of RSUs

  177,876   18   (18)         

Stock-based compensation

        963,372         963,372 

Balances at September 30, 2020

  77,770,284  $7,777  $221,587,384  $(108,634,747) $  $112,960,414 

 

14

 
  

Common Stock

  

Additional Paid-in

  

Accumulated

  

Other Comprehensive

  

Total Stockholders'

 
  

Shares

  

Amount

  

Capital

  

Deficit

  

Income

  

Equity

 

Balances at June 30, 2019

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

Net loss

           (1,205,827)     (1,205,827)

Issuance of common stock

  53,332   5   (5)         
Payment of common stock tendered for employee stock-based compensation tax obligations  (25,576)  (3)  (143,217)          (143,220)

Stock-based compensation

        761,096         761,096 

Balances at September 30, 2019

  81,074,280  $8,107  $221,388,212  $(118,529,803) $  $102,866,516 

 

  

Common Stock

  

Additional Paid-in

  

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

           (2,738,542)     (2,738,542)

Issuance of common stock upon exercise of stock options

  9,769   1   (1)         

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

  121,771   12   (12)         

Issuance of common stock upon exercise of warrants

  159,782   16   1,172,785         1,172,801 
Issuance of common stock  53,332   5   (5)           

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

  (33,724)  (3)  (199,807)        (199,810)

Stock-based compensation

        1,717,380         1,717,380 

Balances at September 30, 2019

  81,074,280  $8,107  $221,388,212  $(118,529,803) $  $102,866,516 

 

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.  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 of the Securities Exchange Act of 1934, as amended, or otherwise. During the three and nine months ended September 30, 2020, the Company repurchased 0.9 million, and 3.7 million shares of common stock, respectively, for approximately $5.6 million, and $21.8 million, respectively.

 

 

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 had 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.

 

On May 26, 2017 the Company and M&F entered into a ten-year office lease agreement (the “New HQ Lease”), pursuant to which the Company agreed to lease 3,200 square feet 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 $0.2 million and $0.2 million for the three months ended September 30, 2020 and 2019, respectively. Operating lease costs totaled $0.5 million and $0.4 million for the nine months ended September 30, 2020 and 2019, respectively. Cash paid for amounts included in the measurement of lease liabilities from operating cash flows was $0.1 million and $0.1 million for the three months ended September 30, 2020 and 2019, respectively. Cash paid for amounts included in the measurement of lease liabilities from operating cash flows was $0.4 million and $0.4 million for the nine months ended September 30, 2020 and 2019, respectively. As of September 30, 2020, the weighted-average remaining lease term of the Company’s operating leases was 5.81 years while the weighted-average discount rate was 4.53%.

 

Future cash flows under operating leases as of September 30, 2020 are expected to be as follows:

 

 

2020

 $98,915 

2021

  600,362 

2022

  368,467 

2023

  402,078 

2024

  404,258 

Thereafter

  982,880 

Total undiscounted cash flows under leases

  2,856,960 

Less: Imputed interest

  (388,143)

Present value of lease liabilities

 $2,468,817 

 

As of September 30, 2020, approximately $2.0 million of the lease liability is included in Other liabilities on the condensed consolidated balance sheet with the current portion included in accrued expenses.

 

 

15

 
 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion should be read in conjunction with our condensed consolidated financial statements and notes to those statements and other financial information appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, the following discussion and other parts of this Quarterly Report contain forward-looking information that involves risks and uncertainties.

 

Overview

 

We are a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is an oral formulation of TPOXX® (“oral TPOXX®”), an antiviral drug for the treatment of human smallpox disease caused by variola virus.

 

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 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 Contract Manufacturing Organizations ("CMOs") that constitute our supply chain, 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 without material disruption to TPOXX®-related manufacture, and in the ordinary course of operations, the supply chain has secured sufficient raw materials to support manufacture and product delivery activities. With regard to day-to-day operations, the COVID-19 pandemic has at times slowed the daily pace of execution of government contracts, as government staff overseeing SIGA contracts has been involved directly or indirectly in the federal government’s response to the pandemic, which has diverted government staff time normally directed toward contract matters involving SIGA. With respect to research and development activities, the Company does expect delays 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 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 or 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, there could be potential risks to our business and cash flows.

 

BARDA Contracts-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 September 30, 2020, 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 bas e 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 September 30, 2020 , the Company had received $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 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 September 30, 2020 and December 31, 2019; 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 September 30, 2020, the Company has received the following payments in connection with exercised options: $11.2 million was received for the procurement of raw materials and such amount was initially recorded as deferred revenue, with $7.7 million of this amount being recognized as revenue due to June and September deliveries of approximately 251,000 courses, in the aggregate, of oral TPOXX® (the remaining $3.5 million of deferred revenue is expected to be recognized as revenue in the fourth quarter of 2020, in conjunction with the delivery to the Strategic Stockpile of approximately 112,000 courses of oral TPOXX®, which contain raw materials for which the Company has been paid); $32.6 million was received in connection with the June delivery of approximately 117,000 courses of oral TPOXX®; and $2.3 million has been received in connection with post-marketing activities for oral TPOXX®. In October 2020, the Company received payment of the $37.3 million account receivable for the September delivery of approximately 134,000 courses of oral TPOXX®. In the third quarter of 2020, $41.4 million of revenue was recognized in connection with this product delivery, of which $37.3 million relates to the amount invoiced for product delivery and acceptance, and $4.1 million relates to amounts that were previously received and recorded as deferred revenue, as such amounts were not previously delivered. During the nine months ended September 30, 2020, $77.7 million of revenue was recognized in connection with the June and September product deliveries, of which $69.9 million relates to the amounts invoiced for product delivery and acceptance, and $7.7 million relates to amounts that were previously received and recorded as deferred revenue, as deliveries containing such amounts of raw materials had not been made. In October, the Company delivered approximately 112,000 courses of oral TPOXX® to the Strategic Stockpile; revenue in conjunction with this product delivery will be included in the fourth quarter of 2020 financial results.

 

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  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 million to fund post-marketing activities for IV TPOXX®; and payments of up to approximately $ 5.6 million for supportive procurement activities.

 

The options related to IV TPOXX® are divided into two primary manufacturing steps. There are options related to the manufacture of bulk drug substance (“IV BDS Options”), and there are corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA may choose to exercise any, all, or none of these options in its sole discretion. The 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. 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 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"). The IV Formulation R&D Contract has a period of performance that terminates in February 2024. As of September 30, 2020, the IV Formulation R&D Contract provides for future aggregate research and development funding of approximately $2.0 million. See Note 3 to the condensed consolidated financial statements regarding the 19C BARDA Contract.

 

In July 2019, the Company was awarded a multi-year research contract valued at a total of $19.5 million, with initial available funding 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 of $26 million with current available funding of $23 million. As of September 30, 2020, the PEP Label Expansion R&D Contract provides for future aggregate research and development funding under the award, as modified, of up to approximately $22.5 million. The period of performance for this contract, as modified, terminates on July 31, 2025.

 

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®

 

On April 3, 2020, the Company announced that the Canadian Department of National Defence (the “CDND”) awarded a contract (the "Canadian Contract") to Meridian Medical Technologies, Inc., a Pfizer Company ("Meridian"), pursuant to which the CDND will purchase up to 15,325 courses of oral TPOXX® over four years for total potential payments of $14.3 million. In the second quarter 2020, CDND purchased 2,500 courses for $2.3 million. The remaining purchases are at the option of the CDND and are expected to occur after regulatory approval of oral TPOXX® in Canada. Meridian is the CDND's counterparty under the Canadian Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder.  The contract award was coordinated between SIGA and Meridian under the international promotion agreement, 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 (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 market, will also retain sales and marketing rights with respect to oral TPOXX®. SIGA’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.

 

 

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 on Form 10-K for the year ended December 31, 2019 as filed on March 5, 2020. 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 September 30, 2020 and 2019

 

For the three months ended September 30, 2020, revenues from product sales and supportive services were $41.8 million, which primarily relate to the delivery and acceptance of approximately 134,000 courses of oral TPOXX® to the Strategic Stockpile under the 19C BARDA Contract. Revenues from product sales and supportive services for the three months ended September 30, 2019 were $3.9 million related to the delivery and acceptance of approximately 12,700 courses of oral TPOXX® to the Strategic Stockpile under the 19C BARDA Contract. 

 

Revenues from research and development activities for the three months ended September 30, 2020 and 2019, were $2.5 million and $4.2 million, respectively. The decrease in revenue of approximately $1.7 million, or 42%, primarily reflects a decrease in revenue from our federal contracts supporting the development of IV TPOXX® and the performance of post-marketing regulatory activities for oral TPOXX®. Revenue in connection with the development of IV TPOXX® has decreased because the scope and cost of development activities related to IV TPOXX® have decreased. 

 

Cost of sales and supportive services for the three months ended September 30, 2020 and 2019 were $5.6 million and $0.7 million, respectively. Such costs in 2020 were associated with the manufacture and delivery of approximately 134,000 courses of oral TPOXX®. Such costs in 2019 were associated with the manufacture and delivery of approximately 12,700 courses of oral TPOXX®. 

 

Selling, general and administrative (“SG&A”) expenses for the three months ended September 30, 2020 and 2019 were $3.6 million and $3.2 million, respectively. The increase of approximately $0.4 million or 12% primarily reflects an increase in regulatory costs associated with our submission of a marketing authorization application ("MAA") with the European Medicines Agency for oral TPOXX®, as well as an increase in professional fees for the quarter.

 

Research and development (“R&D”) expenses for the three months ended September 30, 2020 and 2019 were $2.1 million and $3.3 million, respectively, reflecting a decrease of approximately $1.2 million, or 38%. The decrease is primarily attributable to a decrease in direct vendor-related expenses supporting the development of oral TPOXX® and IV TPOXX® and the performance of post-marketing regulatory activities for oral TPOXX®.

 

 

 

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

 

Interest expense for the three months ended September 30, 2019 was $4.0 million. The $4.0 million of interest for the three months ended September 30, 2019 included $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 September 30, 2020 as our Term Loan 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 three months ended September 30, 2020, we recorded a loss of approximately $1.3 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 September 30, 2019, we recorded a gain of approximately $1.0 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 September 30, 2020. Other income of $0.8 million for the three months ended September 30, 2019 reflected interest income on the Company's cash and cash equivalent balances held in restricted and unrestricted accounts.

 

For the three months ended September 30, 2020 and 2019, we incurred pre-tax income/(loss) of $31.6 million and ($1.6) million, respectively, and a corresponding income tax (provision) benefit of ($7.5) million and $0.4 million, respectively. The effective tax rates during the three months ended September 30, 2020 and 2019 were 23.6% and 23.2%, respectively. Our effective tax rates for the periods ended September 30, 2020 and 2019 differ from the statutory rate primarily as a result of state taxes, non-deductible executive compensation under IRC Section 162(m) and a non-taxable adjustment for the fair market value of the Warrant. 

 

Nine Months Ended September 30, 2020 and 2019

 

For the nine months ended September 30, 2020 and 2019, revenues from product sales and supportive services were $80.5 million and $11.1 million, respectively. Such revenues in 2020 include $77.7 million of revenue related to the delivery and acceptance of approximately 251,000 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 and acceptance of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile under the 19C BARDA Contract. 

 

Revenues from research and development activities for the nine months ended September 30, 2020 and 2019, were $6.7 million and $11.4 million, respectively. The net decrease in revenue of approximately $4.7 million, or 41% primarily reflects the impact of a cumulative catch-up adjustment recognized during the nine months ended September 30, 2019. During the nine months ended September 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 $2.5 million revenue decrease in connection with a decrease in IV TPOXX® activity. These decreases were partially offset by a revenue increase of approximately $1.0 million associated with post-marketing regulatory activities for oral TPOXX®. 

 

Cost of sales and supportive services for the nine months ended September 30, 2020 and 2019, were $10.5 million and $1.7 million, respectively. Such costs in 2020 and 2019 were associated with the manufacture and delivery of approximately 253,000 and 35,700 courses of oral TPOXX®, respectively.

 

Selling, general and administrative (“SG&A”) expenses for the nine months ended September 30, 2020 and 2019, were $10.6 million and $9.8 million, respectively. The increase of approximately $0.8 million or 9% primarily reflects the commission expense associated with the sale of oral TPOXX® to the CDND in May 2020 as well as higher regulatory costs associated with our submission of an MAA with the European Medicines Agency for oral TPOXX®.

 

Research and development (“R&D”) expenses for the nine months ended September 30, 2020 and 2019 were $7.9 million and $9.4 million, respectively, reflecting a decrease of approximately $1.5 million, or 15%. The net decrease is attributable to a decrease in direct vendor-related expenses supporting the development of IV TPOXX® partially offset by an increase in direct vendor-related expenses supporting the performance of post-marketing regulatory activities for oral TPOXX®.

 

 

 

Patent expenses were $0.5 million and $0.5 million, respectively, for the nine months ended September 30, 2020 and 2019. 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 nine months ended September 30, 2020.

 

Interest expense for the nine months ended September 30, 2020 and 2019 was $3.0 million and $11.9 million, respectively. The $3.0 million of interest for the nine months ended September 30, 2020 includes $0.9 million of accretion of unamortized costs and fees (prior to repayment of the Term Loan). The $11.9 million of interest for the nine months ended September 30, 2019 includes $3.4 million of accretion of unamortized costs and fees related to the Term Loan balance.

 

Changes in the fair value of the liability-classified warrant to acquire common stock were recorded within the income statement. For the nine months ended September 30, 2020, we recorded a loss of approximately $2.9 million, reflecting an increase in fair value of the liability-classified warrant primarily due to the increase in our stock price. For the nine months ended September 30, 2019, we recorded a gain of approximately $4.8 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  $0.5 million and $2.2 million for the nine months ended September 30, 2020 and 2019, respectively reflects interest income on the Company's cash and cash equivalent balances held in restricted and unrestricted accounts.

 

For the nine months ended September 30, 2020 and 2019, we incurred pre-tax income/(loss) of $47.3 million and ($3.7) million, respectively, and a corresponding income tax (provision) benefit of ($11.1) million and $1.0 million, respectively. The effective tax rates during the nine months ended September 30, 2020 and 2019 were 23.4% and 26.3%, respectively. Our effective tax rates for the periods ended September 30, 2020 and 2019 differ from the statutory rate primarily as a result of state taxes, non-deductible executive compensation under IRC Section 162(m) and a non-taxable adjustment for the fair market value of the Warrant. 

 

Liquidity and Capital Resources

 

As of September 30, 2020, we had $78.7 million in cash and cash equivalents compared with $65.2 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 September 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 approximate 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/(loss) to cash flows from operating activities by adjusting net income/(loss) for those items that impact net 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, 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 provided by/(used in) operating activities for the nine months ended September 30, 2020 and 2019 was $25.6 million and ($3.9) million, respectively. For the nine months ended September 30, 2020, the receipt of approximately $32.6 million from BARDA for product delivery and acceptance was partially offset by net cash usage primarily related to customary operating activities. For the nine months ended September 30, 2019, we incurred $8.5 million of cash interest expense on the Term Loan and used approximately $0.8 million in support of ordinary course working capital (accounts receivable, accounts payable, and prepaids, among other items). Additionally, cash was used for customary operating activities. These cash uses were partially offset by the receipt of approximately $11.1 million from BARDA for product delivery; $11.4 million from R&D contracts; and $2.2 million of interest income.

 

Investing Activities

For the nine months ended September 30, 2020 and 2019, we used cash in the amounts of $15,501 and $29,092, respectively, for capital expenditures.

 

Financing Activities

Net cash used in financing activities for the nine months ended September 30, 2020 was $107.9 million, which was principally attributable to our voluntary prepayment of the Term Loan, of which approximately $85.9 million is recorded as a financing activity, and our repurchase of 3.7 million shares of common stock for approximately $21.8 million. Net cash used by financing activities for the nine months ended September 30, 2019 was $0.2 million, which was attributable to the payment of tax obligations for employee common stock tendered. 

 

Off-Balance Sheet Arrangements

 

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

 

 

Recently Issued Accounting Standards

 

For discussion regarding the impact of accounting standards that were recently adopted on the Company's condensed consolidated financial statements, 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 “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 SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the BARDA Contracts, not to exercise 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’s responses (including inaction) to the national or global economic situation or infectious disease such as COVID-19 may affect SIGA’s business adversely, as well as the risks and uncertainties included in Item 1A “Risk Factors” on Form 10-K for the fiscal year ended December 31, 2019. 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 issuers 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 1.5 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 million.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2020. The term “disclosure controls and procedures” is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934. Management recognizes that any disclosure controls and procedures no matter how well designed and operated, can only provide reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of September 30, 2020 at a reasonable level of assurance.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting during the quarter ended September 30, 2020 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 

 

 

PART II-OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time, we may be involved in a variety of claims, suits, investigations and proceedings arising from the ordinary course of our business, collections claims, breach of contract claims, labor and employment claims, tax and other matters. Although such claims, suits, investigations and proceedings are inherently uncertain and their results cannot be predicted with certainty, we believe that the resolution of such current pending matters, if any, will not have a material adverse effect on our business, condensed consolidated financial position, 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 2019 Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

 

Item 2. Unregistered Sale 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

 

July 1, 2020 to July 31, 2020

    527,932     $ 5.94       527,932     $ 30,645,387  

August 1, 2020 to August 31, 2020

    38,502       6.70       38,502       30,387,430  

September 1, 2020 to September 30, 2020

    320,038       6.78       320,038       28,216,709  
      886,472     $ 6.28       886,472          

 

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 to executing any repurchases under this program, the Company’s Term Loan needed to be fully repaid or its terms needed to be amended to allow for share repurchases. 

 

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.

 

 

Item 6. Exhibits

 

Exhibit No.

Description

3.1 Amended and Restated Certificate of Incorporation of SIGA Technologies, Inc. (incorporated by reference to the Current Report on Form 8-K of the Company filed on April 14, 2016).
3.2 Amended and Restated Bylaws of SIGA Technologies, Inc. (incorporated by reference to the Current Report on Form 8-K of the Company filed on April 14, 2016). 
3.3 Amendment to Amended and Restated Bylaws of SIGA Technologies, Inc. (incorporated by reference to the Current Report on Form 8-K of the Company filed on December 13, 2016). 
10.1 Amendment of Solicitation/Modification of Contract 00021, dated July 2, 2020, to Agreement, dated June 1, 2011 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).
10.2

Amendment of Solicitation/Modification of Contract 00019, dated July 20, 2020, to Agreement, dated May 13, 2011 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

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

 

 

SIGNATURES

 

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

 

 

 

 

SIGA TECHNOLOGIES, INC.

 

 

(Registrant)

 

 

 

Date:

 November 5, 2020

By:

/s/ Daniel J. Luckshire

 

 

 

 

Daniel J. Luckshire

 

 

 

 

Executive Vice President and Chief Financial Officer

 

 

 

(Principal Financial Officer and Principal Accounting Officer)

 

 

 

24
ex_207022.htm
      Exhibit 10.1
       

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF

1

PAGES

4

2. AMENDMENT/MODIFICATION NO.

P00021

3. EFFECTIVE DATE

See Block 16C

4. REQUISITION/PURCHASE REQ. NO.

OS260888

5. PROJECT NO. (if applicable)

ASPR-20-02608

6. ISSUED BYCODE

HHS/OS/ASPR/BARDA

7. ADMINISTERED BY (if other than item 6) 

CODE 

ASPR-BARDA02

HHS/OS/ASPR/BARDA

330 Independence Ave., S.W.

Room 640-G

Washington DC 20201

 

ASPR-BARDA

330 Independence Ave, SW, Rm G640

Washington DC 20201

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

 

SIGA TECHNOLOGIES, INC. 1385150

SIGA TECHNOLOGIES, INC. 35 E 6

35 E 62ND ST

NEW YORK NY 100658014

 

 

 

(x)

9A. AMENDMENT OF SOLICITATION NO.

 

     
   

9B. DATED (SEE ITEM 11)

 

 

x

10A. MODIFICATION OF CONTRACT/ORDER NO.

HHSO100201100023C

   

10B. DATED (SEE ITEM 13)

06/01/2011

CODE1385150

FACILITY CODE

   

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

☐The above numbered solicitation is amended as set forth in Item 14.  The hour and date specified for receipt of Offers☐ is extended. ☐ is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (if required)

See Schedule

Net Increase:

$1,783.62

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE

A.THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

   
 

B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

X

C.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

52.243-2 Changes — Cost Reimbursement, Alternate V

 

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor☐ is not☒ is required to sign this document and return __________1____ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Tax ID Number: 13-3864870

DUNS Number: 932651516

Modification 21 accomplishes the following:

 

1) No-cost time extension of the following CLINS required for on-going activities include product stability, manufacturing and process development, clinical and regulatory studies:

 

CLIN 0003 = PH IV Opt 2 02/08/2017 to 12/30/2020 extended to 2/8/2024

CLIN 0004 = PH IV Opt 3 02/08/2017 to 12/30/2020 extended to 2/8/2024

CLIN 0005 = PH IV Opt 4 02/08/2017 to 12/30/2020 extended to 2/8/2024

CLIN 0007 = PH IV Opt 6 02/08/2017 to 12/30/2020 extended to 2/8/2024

Continued ...

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

 

Dennis E. Hruby, CSO

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

 

JOHN K. WARNER

15B. CONTRACTOR/OFFEROR

 

/s/ Dennis E. Hruby
(Signature of person authorized to sign)

15C. DATE SIGNED

 

02 Jul 2020

16B. UNITED STATES OF AMERICA

 

/s/ John K. Warner -S
(Signature of Contracting Officer)

16C. DATE SIGNED

 

07/02/2020

 

Previous edition unusable

    STANDARD FORM 30 (REV. 11/2016)
      Prescribed by GSA FAR (48 CFR) 53.243
       

 

 

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHSO100201100023C/P00021

PAGE

2

OF

4

NAME OF OFFEROR OR CONTRACTOR

SIGA TECHNOLOGIES, INC. 1385150

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

 

2) Provides $1,783.62 in supplemental funding for balance of funds needed for conclusion of product manufacturing process method development under CLIN 0006. Permits remittance of invoice 111-23C.

       
           
 

3) Revises Article G.1-A changing the Contracting Officer from George J. Keane, Jr. to John K. Warner

       
           
 

4) Revises Subsection G.1 changing the Project Officer / Contracting Officer’s Representative from David Simon, Ph.D. to Annie Xi Lu, Ph.D.

       
           
 

See supplemental pages for additional information. All other terms and conditions of contract HHSO100201100023C remain unchanged.

       
           
 

Discount Terms: PSC NET 30P
Period of Performance: 05/15/2011 to 02/08/2024

       
           
 

Change Item 7 to read as follows (amount shown is the obligated amount):

       
           

7

ASPR-17-00856 Exercise of CLINS 3 4 5 7 8

     

0.00

           
 

Accounting Info:
2017.1992017.25103 Appr. Yr.: 2017 CAN: 1992017 Object Class: 25103
Funded: $0.00

       
           
 

Accounting Info:
2019.1992019.25106 Appr. Yr.: 2019 CAN: 1992019 Object Class: 25106
Funded: $0.00

       
           
 

Accounting Info:
2019.1992018.25106 Appr. Yr.: 2019 CAN: 1992018 Object Class: 25106
Funded: $0.00

       
           
 

No-Cost Time Extensions of PoPs for CLIN 3, 4, 5, and 7 required for on-going activities include product stability, manufacturing and process development, clinical and regulatory studies.

       
           
 

CLIN 0003 = PH IV Opt 2 02/08/2017 thru 12/30/2020 extended to 2/8/2024
CLIN 0004 = PH IV Opt 3 02/08/2017 thru 12/30/2020 extended to 2/8/2024
CLIN 0005 = PH IV Opt 4 02/08/2017 thru 12/30/2020 extended to 2/8/2024
CLIN 0007 = PH IV Opt 6 02/08/2017 thru 12/30/2020 extended to 2/8/2024

       
           
 

Add Item 8 as follows:

       
           

8

ASPR-20-02608 -- add funds to CLIN 0006 for final costs related to product manufacturing process method development under contract HHSO100201100023C
Continued …

 

 

 

 

 

 

 

     

1,783.62

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

 

 

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHSO100201100023C/P00021

PAGE

3

OF

4

NAME OF OFFEROR OR CONTRACTOR

SIGA TECHNOLOGIES, INC. 1385150

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

 

Obligated Amount: $1,783.62

       
           
 

Accounting Info:
2020.1992020.25106 Appr. Yr.: 2020 CAN: 1992020 Object Class: 25106
Funded: $1,783.62

       
           
 

balance of funds needed to conclude Scale-up, Process Validation and DP Stability performed under CLIN 0006 and to remit associated G&A / fee applicable to final billing for CLIN 0006 work per invoice No.111-2
-
PSC: AN13 NAICS: 541711 COR is Annie Lu, Ph.D. (202) 604-5814, Xi.Lu@hhs.gov

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

Contract No. HHSO100201100023C

SIGA Technologies, Inc.

Modification No21: P00021

SPECIAL PROVISIONS

Page 4 of 4

 

Beginning with the effective date of this modification, the Government and the Contractor mutually agree as follows:

 

ARTICLE G.1PROJECT OFFICER — is revised as follows:

 

The following Contracting Officer Representative (COR) will represent the USG for the purpose of this contract:

 

Annie Xi Lu
Project Officer, Antivirals & Antitoxins
DHHS/OS/ASPR/BARDA
200 C Street, SW
Washington, DC 20515
C: (202) 604-5814
xi.lu@hhs.gov

 

ARTICLE G.1-A CONTRACTING OFFICER — is revised as follows:

 

The following Contracting Officer (CO) will represent the USG for the purpose of this contract:

 

John K. Warner
Contracting Officer
DHHS/OS/ASPR/BARDA
200 C Street, SW
Washington, DC 20515
(202) 805-4185
john.warner@hhs.gov

 

(End of Section)

 

 

 

End of Modification P00021

 

All other terms and conditions of the contract remain in full force and effect.

 

 

 
ex_207023.htm
    Exhibit 10.2
     

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF PAGES

   

1

4

2. AMENDMENT/MODIFICATION NO.

P00019

3. EFFECTIVE DATE

See Block 16C

4. REQUISITION/PURCHASE REQ. NO.

5. PROJECT NO. (If applicable)

6. ISSUED BYCODE

ASPR-BARDA

7. ADMINISTERED BY (If other than Item 6)

CODE  
       

ASPR-BARDA

200 Independence Ave., S.W.

Room 640-G

Washington DC 20201

 

 

 

 

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

 

SIGA TECHNOLOGIES, INC. 1385150

Attn: Daniel Luckshire

SIGA TECHNOLOGIES, INC. 35 E 6

35 E 62ND ST

NEW YORK NY 100658014

 

 

(X)

9A. AMENDMENT OF SOLICITATION NO.

 

     
   

9B. DATED (SEE ITEM 11)

 

 

X

10A. MODIFICATION OF CONTRACT/ORDER NO.

HHSO100201100001C

   

10B. DATED (SEE ITEM 13)

05/13/2011

CODE 1385150

FACILITY CODE

   

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

☐ The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers☐is extended.☐is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing

Items 8 and 15, and returning     ______ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

See Schedule

13. THIS ITEM APPLIES ONLY TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE

A.THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

   
 

B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

X

C.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

FAR 52.243-2 Changes - Cost Reimbursement, Alternate I

 

D.OTHER (Specify type of modification and authority)

E. IMPORTANT:Contractor☐ is not☒ is required to sign this document and return ________1___________ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Tax ID Number: 13-3864870

DUNS Number: 932651516

Modification 19 accomplishes the following no-cost administrative actions:

1.IAW with Section C.1, Section F.1 Period of Performance for Base CLINS 0007 and 0008 PoP are extended as indicated in Attachment 1.

2.IAW with Section C.7, Section F.1 Period of Performance for Option CLINS 0007 and 0008 PoP is extended from 06/28/2016 through 09/20/2020 to 06/28/2016 through 12/09/2022 as indicated in Attachment 1.

3.Revises Article G.1 changing the Contracting Officer from George J. Keane, Jr. to John K. Warner.

4.Revises Article G.2 changing the Contracting Officer's Representative from David Simon,

Continued ...

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

Dennis E. Hruby, CSO

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

JOHN K. WARNER

15B. CONTRACTOR/OFFEROR

 

 

/s/ Dennis E. Hruby

(Signature of person authorized to sign)

15C. DATE SIGNED

20 Jul 2020

16B. UNITED STATES OF AMERICA

 

 

/s/ John K. Warner

(Signature of Contracting Officer)

16C. DATE SIGNED

07/20/2020

Previous edition unusable     STANDARD FORM 30 (REV. 11/2016)
      Prescribed by GSA FAR (48 CFR) 53.243

 

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHSO100201100001C/P00019

PAGE OF

   

  2

 4

NAME OF OFFEROR OR CONTRACTOR

SIGA TECHNOLOGIES, INC. 1385150

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

 

Ph.D. to Annie Xi Lu Ph.D..

 

All other terms and conditions of contract HHSO100201100001C remain unchanged.

Discount Terms: PSC NET 30P

Period of Performance: 06/28/2016 to 09/21/2023

 

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

       
           

1

Smallpox Antiviral Drug for the Strategic National Stockpile

 

Accounting Info:

2011.1990001.26402 Appr. Yr.: 2011 CAN: 1990001 Object Class: 26402

Funded: $0.00

 

Accounting Info:

2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103

Funded: $0.00

 

Accounting Info:

2018.199TWNP.26201 Appr. Yr.: 2018 CAN: 199TWNP Object Class: 26201

Funded: $0.00

FOB: Destination

 

No-cost time extension for CLIN 0008.11 Physical and IT security funding in support of completion FDA requested additional regulatory studies that involve the Geriatric and Pediatric formulation of the oral TPOXX PoP changed to 06/28/2016 through 12/09/2022

 

Change Item 3 to read as follows(amount shown is the obligated amount):

     

0.00

           

3

CLIN 0007 Smallpox Antiviral Drug for the Strategic National Stockpile – Supportive Clinical and Non-clinical Studies

 

Accounting Info:

2013.1992002.25106 Appr. Yr.: 2013 CAN: 1992002 Object Class: 25106

Funded: $0.00

 

Accounting Info:

2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103

Funded: $0.00

 

Accounting Info:

2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103

Funded: $0.00

 

Accounting Info:

Continued ...

     

0.00

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

 

 

 

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHSO100201100001C/P00019

PAGE OF

   

 3

 4

NAME OF OFFEROR OR CONTRACTOR

SIGA TECHNOLOGIES, INC. 1385150

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

 

2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103

Funded: $0.00

FOB: Destination

 

No-cost time extension to comply with FDA requested additional supportive studies.

CLIN 0007.12 Specific PoP extended to 04/22/2023

CLIN 0007.14 Specific PoP extended to 09/21/2023

 

Change Item 5 to read as follows (amount shown is the obligated amount):

       
           

5

No-cost extension of CLIN 00018, Geriatric Formulation ASPR-16-00275

PoP changed to 06/28/2016 through 12/09/2022

 

Accounting Info:

2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103

Funded: $0.00

 

No-cost time extension for FDA requested additional regulatory studies that involve the Geriatric formulation of the oral TPOXX

 

Change Item 6 to read as follows(amount shown is the obligated amount):

     

0.00

           

6

No-cost extension of CLIN 00021, Pediatric Formulation ASPR-16-00275

PoP changed to 06/28/2016 through 12/09/2022

 

Accounting Info:

2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103

Funded: $0.00

 

No-cost time extension for completion of FDA requested regulatory studies that involve the Pediatric formulation of the oral TPOXX

-

PSC: 6505 NAICS: SAM has 541714 recorded; FPDS_NG reflects 541711 for Mod 17

 

 

 

 

 

 

 

 

 

 

 

 

     

0.00

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

 

Contract No.

HHSO100201100001C

Modification No.19

Attachment 1

Page 4 of 4

 

Beginning with the effective date of this modification, the U.S. Government and Contractor mutually agree as follows:

 

1.

IAW with Section C.1, Section F.1 Period of Performance, the periods of performance for the following CLINS are revised as indicated:

 

CLIN

Scope

Contract Mod

Date Exercised

Previous POP

End Date

Revised POP End

Date

0007.12

Additional supportive studies

0012

22 Apr 2016

24 Sep 2020

22 Apr 2023

0007.14

Additional supportive studies

0014

21 Sep 2016

24 Sep 2020

21 Sep 2023

0008.11

Physical and IT security

0011

09 Dec 2015

24 Sep 2020

09 Dec 2022

 

2.

IAW with Section C.7, Section F.1 Period of Performance, the periods of performance for Option CLINS 0007 and 0008 are revised as indicated:

 

CLIN

Scope