UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
| | Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
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| For the Quarterly Period Ended |
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| Or |
| | Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
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| For the transition period from ________ to ___________ |
Commission File No.
SIGA Technologies, Inc.
(Exact name of registrant as specified in its charter)
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| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
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Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| | | The |
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.
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).
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 ☐ | |
| Non-accelerated filer ☐ | Smaller reporting company |
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| 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
As of October 21, 2022, the registrant had outstanding
SIGA TECHNOLOGIES, INC.
FORM 10-Q
Table of Contents
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Page No. |
| Management's Discussion and Analysis of Financial Condition and Results of Operations |
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PART I - FINANCIAL INFORMATION
Item 1 - Condensed Consolidated Financial Statements
SIGA TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
| September 30, 2022 | December 31, 2021 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable | ||||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Property, plant and equipment, net | ||||||||
| Deferred income taxes, net | ||||||||
| Goodwill | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses and other current liabilities | ||||||||
| Income tax payable | ||||||||
| Total current liabilities | ||||||||
| Warrant liability | ||||||||
| Other liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Common stock ($ par value, shares authorized, and , issued and outstanding at September 30, 2022 and December 31, 2021, respectively) | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
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, |
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| 2022 |
2021 |
2022 |
2021 |
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| Revenues |
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| Product sales and supportive services |
$ | $ | $ | $ | ||||||||||||
| Research and development |
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| Total revenues |
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| Operating expenses |
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| Cost of sales and supportive services |
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| Selling, general and administrative |
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| Research and development |
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| Total operating expenses |
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| Operating income/(loss) |
( |
) | ( |
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| Gain/(loss) from change in fair value of warrant liability |
( |
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| Other income, net |
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| Income/(loss) before income taxes |
( |
) | ( |
) | ||||||||||||
| (Provision)/benefit for income taxes |
( |
) | ( |
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| Net and comprehensive income/(loss) |
$ | $ | ( |
) | $ | $ | ( |
) | ||||||||
| Basic income/(loss) per share |
$ | $ | ( |
) | $ | $ | ( |
) | ||||||||
| Diluted income/(loss) per share |
$ | $ | ( |
) | $ | $ | ( |
) | ||||||||
| Weighted average shares outstanding: basic |
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| Weighted average shares outstanding: diluted |
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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, |
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| 2022 |
2021 |
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| Cash flows from operating activities: |
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| Net income (loss) |
$ | $ | ( |
) | ||||
| Adjustments to reconcile net income (loss) to net cash used in operating activities: |
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| Depreciation and other amortization |
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| Gain on change in fair value of warrant liability |
( |
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| Stock-based compensation |
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| Write down of inventory, net |
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| Deferred income taxes, net |
( |
) | ( |
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| Changes in assets and liabilities: |
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| Accounts receivable |
( |
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| Inventory |
( |
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| Prepaid expenses and other assets |
( |
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| Accounts payable, accrued expenses and other liabilities |
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| Income tax payable |
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| Deferred revenue |
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| Net cash provided by/(used in) operating activities |
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| Cash flows from investing activities: |
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| Capital expenditures |
( |
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| Cash used in investing activities |
( |
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| Cash flows from financing activities: |
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| Payment of employee tax obligations for common stock tendered |
( |
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| Repurchase of common stock |
( |
) | ( |
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| Payment of dividend |
( |
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| Cash used in financing activities |
( |
) | ( |
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| Net increase/(decrease) in cash and cash equivalents |
( |
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| Cash and cash equivalents at the beginning of period |
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| Cash and cash equivalents at end of period |
$ | $ | ||||||
| Supplemental disclosure of non-cash financing activities: |
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| Conversion of warrant to common stock |
$ | $ | ||||||
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 of SIGA Technologies, Inc. (“we,” “our,” “us,” “SIGA” or the “Company”) are presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the rules and regulations of the Securities and Exchange Commission (the “SEC”) for quarterly reports on Form 10-Q and should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2021, included in the Company's 2021 Annual Report on Form 10-K filed on March 3, 2022 (the "2021 Form 10-K"). All terms used but not defined elsewhere herein have the meaning ascribed to them in the 2021 Form 10-K. In the opinion of management, all adjustments (consisting of normal and recurring adjustments) considered necessary for a fair statement of the results of the interim periods have been included. The 2021 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, 2022 are not necessarily indicative of the results expected for the full year.
2. Summary of Significant Accounting Policies
Revenue Recognition
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. The Company accounts for shipping and handling activities as fulfillment costs rather than as an additional promised service. As of September 30, 2022, the Company's active contractual performance obligations are referenced in Note 3 and consist of the following: five performance obligations relate to research and development services; and five relate to manufacture and delivery of product. The aggregate amount of the transaction price allocated to remaining performance obligations was $
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, 2022, the accounts receivable balance in the condensed balance sheet includes approximately $
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).
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
The base period of performance specifies potential payments of approximately $
The options that have been exercised to date provide for payments up to approximately $
Unexercised options specify potential payments up to approximately $
The options related to IV TPOXX® are divided into 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: separate IV BDS Options, each providing for the bulk drug substance equivalent of
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 from 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, 2022 and 2021, the Company recognized revenues of $
U.S. Department of Defense Procurement Contracts
On May 12, 2022, the Company announced a contract with the U.S. Department of Defense ("DoD") for the procurement of oral TPOXX® ("DoD Contract #1"). The DoD Contract #1 included a firm commitment for the DoD to procure approximately $
On September 28, 2022, the Company and the DoD signed a new procurement contract ("DoD Contract #2"). The DoD Contract #2 includes a firm commitment for the DoD to procure approximately $
International Procurement Contracts
This year, through October 31, 2022, the Company has received firm commitment orders from 13 international customers (including Canada) for the delivery of approximately $
On January 13, 2021, PHAC awarded a contract to Meridian (the “PHAC Contract”) for the purchase of up to approximately $
On April 3, 2020, the Company announced that the CDND awarded a contract (the "Canadian Military Contract") to Meridian, pursuant to which the CDND would purchase up to approximately $
The above-listed contract awards were 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 International Promotion Agreement, Meridian is the counterparty in connection with international contracts for oral TPOXX® and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder.
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 retains ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retains sales and marketing rights with respect to oral TPOXX®. SIGA’s consent is required for the entry into any sales arrangement pursuant to the International Promotion Agreement.
The fee Meridian retains pursuant to the International Promotion Agreement is a specified percentage of the collected proceeds of sales of oral TPOXX® net of certain expenses, for calendar years in which customer collected 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 calendar years in which such net collected amounts exceed the specified threshold. It is probable that we will exceed the specified threshold in 2022 and, as a result, the Company has recorded and will continue to record the higher specified percentage for all International Promotion Agreement sales in 2022.
Revenue in connection with international procurement contracts for the delivery of product are recognized at a point in time on a gross basis, as the Company acts as the principal in the transaction. During the three and nine months ended September 30, 2022, the Company recognized $
Research Agreements and Grants
In July 2019, the Company was awarded a multi-year research contract valued at a total of $
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, the Company may not be eligible to receive all available funds.
Inventory includes costs related to the manufacture of TPOXX®. Inventory consisted of the following:
| As of |
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| September 30, 2022 |
December 31, 2021 |
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| Raw materials |
$ | $ | ||||||
| Work in-process |
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| Finished goods |
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| Inventory |
$ | $ | ||||||
5. Property, Plant and Equipment
Property, plant and equipment consisted of the following:
| As of | ||||||||
| September 30, 2022 | December 31, 2021 | |||||||
| Leasehold improvements | $ | $ | ||||||
| Computer equipment | ||||||||
| Furniture and fixtures | ||||||||
| Operating lease right-of-use assets | ||||||||
| Less - accumulated depreciation and amortization | ( | ) | ( | ) | ||||
| Property, plant and equipment, net | $ | $ | ||||||
Depreciation and amortization expense on property, plant, and equipment was $
6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
| As of |
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| September 30, 2022 |
December 31, 2021 |
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| Deferred revenue |
$ | $ | ||||||
| Compensation |
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| Research and development vendor costs |
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| Professional fees |
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| Other |
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| Lease liability, current portion |
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| Inventory |
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| Accrued expenses and other current liabilities |
$ | $ | ||||||
2016 Warrant
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”). The Company voluntarily prepaid this Loan Agreement in 2020. Upon such prepayment and release, the Loan Agreement was terminated. In connection with the entry into the Loan Agreement, the Company issued a warrant (the “Warrant”) to the Lender on September 2, 2016 to purchase a number of shares of the Company’s common stock equal to $
In the second quarter of 2022, the Warrant was fully exercised, and therefore there are
As of December 31, 2021, there were approximately
8. Fair Value of Financial Instruments
The carrying value of cash equivalents, accounts receivable, accounts payable, accrued expenses and other current liabilities, and income tax payable approximates fair value due to the relatively short maturity of these instruments. Prior to being fully exercised, common stock warrants, which were classified as a liability, were 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. |
There were no transfers between levels of the fair value hierarchy for the nine months ended September 30, 2022. As of each of September 30, 2022 and December 31, 2021, the Company had approximately $
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, 2021 | $ | |||
| Decrease in fair value of Warrant liability | ( | ) | ||
| Exercise of Warrant | ( | ) | ||
| Warrant liability at September 30, 2022 | $ | |||
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, |
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| 2022 |
2021 |
2022 |
2021 |
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| Net income/(loss) for basic earnings per share |
$ | $ | ( |
) | $ | $ | ( |
) | ||||||||
| Less: Change in fair value of warrants |
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| Net income/(loss), adjusted for change in fair value of warrants for diluted earnings per share |
$ | $ | ( |
) | $ | $ | ( |
) | ||||||||
| Weighted-average shares |
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| Effect of potential common shares |
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| Weighted-average shares: diluted |
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| Income/(loss) per share: basic |
$ | $ | ( |
) | $ | $ | ( |
) | ||||||||
| Income/(loss) per share: diluted |
$ | $ | ( |
) | $ | $ | ( |
) | ||||||||
For the nine months ended September 30, 2022, the diluted earnings per share calculation reflects the effect of the exercise of outstanding warrants and any corresponding elimination of the impact included in operating results from the change in fair value of the warrants. Weighted-average diluted shares include the dilutive effect of in-the-money options, stock-settled RSUs and warrants. The dilutive effect of warrants, stock-settled RSUs and options is calculated based on the average share price for each fiscal period using the treasury stock method. Under the treasury stock method, the amount the employee must pay for exercising stock options, the average amount of compensation cost for future service that the Company has not yet recognized, and the amount of tax benefits that would be recorded in additional paid-in capital when the award becomes deductible, are collectively assumed to be used to repurchase shares. Cash-settled RSUs 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, 2022 because the net effect of their inclusion, including the elimination of the impact in the operating results of the change in fair value of these RSUs, would have been anti-dilutive. For the three and nine months ended September 30, 2022, the weighted average number of shares under the cash-settled RSUs excluded from the calculation of diluted earnings per share were
For the three and nine months ended September 30, 2021, 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, | |||||||
| 2021 |
2021 |
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| Warrants |
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| Stock options |
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| Restricted stock units |
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10. Commitments and Contingencies
From time to time, we may be involved in a variety of claims, suits, investigations and proceedings arising from the ordinary course of our business, collections claims, breach of contract claims, labor and employment claims, tax and other matters. Although such claims, suits, investigations and proceedings are inherently uncertain and their results cannot be predicted with certainty, we believe that the resolution of such current pending matters, if any, will not have a material adverse effect on our business, consolidated financial position, results of operations or cash flow. Regardless of the outcome, litigation can have an adverse impact on us because of legal costs, diversion of management resources and other factors.
Purchase Commitments
In the course of our business, the Company regularly enters into agreements with third party organizations to provide contract manufacturing services and research and development services. Under these agreements, the Company issues purchase orders, which obligate the Company to pay a specified price when agreed-upon services are performed. In connection with many CMO purchase orders, reimbursement by CMOs for inventory losses is limited. Commitments under the purchase orders do not exceed our planned commercial and research and development needs. As of September 30, 2022, the Company had approximately $
11. Related Party Transactions
Board of Directors and Outside Counsel
A former member of the Company’s Board of Directors who did not stand for re-election at the Company's 2021 annual meeting of stockholders is a partner at a law firm used by the Company. The Company did incur any expenses related to services provided by the outside counsel during the three months ended September 30, 2022 and 2021 or the nine months ended September 30, 2022. During the nine months ended September 30, 2021, the Company incurred $
Real Estate Leases
On May 26, 2017, the Company and MacAndrews & Forbes Incorporated (“M&F”) entered into a -year Office Lease agreement (the “HQ Lease”), pursuant to which the Company agreed to lease
12. Revenues by Geographic Region
Revenues by geographic region were as follows:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
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| 2022 |
2021 |
2022 |
2021 |
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| United States |
$ | $ | $ | $ | ||||||||||||
| International |
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| Asia-Pacific |
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| Canada |
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| Europe, Middle East and Africa (EMEA) |
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| Other |
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| Total International |
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| Total revenues |
$ | $ | $ | $ | ||||||||||||
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.
For the three months ended September 30, 2022 and 2021, we recorded pre-tax income of $
For the nine months ended September 30, 2022 and 2021, we recorded pre-tax income of $
The effective tax rate for the three months ended September 30, 2022 was
The effective tax rate for the nine months ended September 30, 2022 was
The Inflation Reduction Act of 2022 (the “Act”) was signed into U.S. law on August 16, 2022. The Act includes various tax provisions, including an excise tax on stock repurchases, expanded tax credits for clean energy incentives, and a corporate alternative minimum tax that generally applies to U.S. corporations with average adjusted annual financial statement income over a three-year period in excess of $1 billion. The Company does not expect the Act to materially impact its consolidated financial statements.
The tables below present changes in stockholders' equity for the three and nine months ended September 30, 2022 and 2021.
| Common Stock |
Additional Paid-in |
Accumulated |
Other Comprehensive |
Total Stockholders' | ||||||||||||||||||||
| Shares |
Amount |
Capital |
Deficit |
Income |
Equity |
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| Balances at June 30, 2022 |
$ | $ | $ | ( |
) | $ | $ | |||||||||||||||||
| Net income |
— | |||||||||||||||||||||||
| Stock-based compensation |
— | |||||||||||||||||||||||
| Balances at September 30, 2022 |
$ | $ | $ | ( |
) | $ | $ | |||||||||||||||||
| Common Stock |
Additional Paid-in |
Accumulated |
Other Comprehensive |
Total Stockholders' |
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| Shares |
Amount |
Capital |
Deficit |
Income |
Equity |
|||||||||||||||||||
| Balances at December 31, 2021 |
$ | $ | $ | ( |
) | $ | $ | |||||||||||||||||
| Net income |
— | |||||||||||||||||||||||
| Repurchase of common stock |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
| Payment of common stock tendered for employee stock-based compensation tax obligations |
( |
) | ( |
) | ( |
) | ||||||||||||||||||
| Issuance of common stock upon vesting of RSUs |
( |
) | ||||||||||||||||||||||
| Issuance of common stock upon exercise of warrants |
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| Cash dividend ($0.45 per share) |
— | ( |
) | ( |
) | |||||||||||||||||||
| Stock-based compensation |
— | |||||||||||||||||||||||
| Balances at September 30, 2022 |
$ | $ | $ | ( |
) | $ | $ | |||||||||||||||||
| Common Stock |
Additional Paid-in |
Accumulated |
Other Comprehensive |
Total Stockholders' |
||||||||||||||||||||
| Shares |
Amount |
Capital |
Deficit |
Income |
Equity |
|||||||||||||||||||
| Balances at June 30, 2021 |
$ | $ | $ | ( |
) | $ | $ | |||||||||||||||||
| Net loss |
— | ( |
) | ( |
) | |||||||||||||||||||
| Repurchase of common stock |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
| Payment of common stock tendered for employee stock-based compensation tax obligations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
| Issuance of common stock upon vesting of RSUs |
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| Stock-based compensation |
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| Balances at September 30, 2021 |
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| Common Stock |
Additional Paid-in |
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Total Stockholders' |
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Deficit |
Income |
Equity |
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| Balances at December 31, 2020 |
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) | $ | $ | |||||||||||||||||
| Net loss |
— | ( |
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| Repurchase of common stock |
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) | ( |
) | ( |
) | ( |
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| Payment of common stock tendered for employee stock-based compensation tax obligations |
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) | ( |
) | ( |
) | ( |
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| Issuance of common stock upon vesting of RSUs |
( |
) | ||||||||||||||||||||||
| Stock-based compensation |
— | |||||||||||||||||||||||
| Balances at September 30, 2021 |
$ | $ | $ | ( |
) | $ | $ | |||||||||||||||||
On August 2, 2021, the Company's Board of Directors authorized a share repurchase program ("New Repurchase Authorization") under which the Company may repurchase up to $
Prior to the effective date of the New Repurchase Authorization, the Company repurchased shares under a program that was announced in March 2020. Under this program, $
On May 5, 2022, the Board of Directors declared a special dividend of $
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 years and the other for years. In the second quarter of 2019, the Company exercised the first renewal option, which extended the lease expiration date to December 31, 2021. In the second quarter of 2021, the Company exercised the second renewal option, which extended the lease expiration date to December 31, 2024. In connection with the exercise of the second renewal option, the Company recorded an increase to operating lease right-of-use assets and operating lease liabilities of approximately $
On May 26, 2017 the Company and M&F entered into the HQ Lease, a -year office lease agreement, pursuant to which the Company agreed to lease
Operating lease costs totaled $
Future cash flows under operating leases as of September 30, 2022 are expected to be as follows:
| 2022 |
$ | |||
| 2023 |
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| 2024 |
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| 2025 |
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| 2026 |
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| Thereafter |
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| Total undiscounted cash flows under leases |
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| Less: Imputed interest |
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| Present value of lease liabilities |
$ |
As of September 30, 2022, approximately $
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 and in the Company's Annual Report on Form 10-K filed on March 3, 2022 (the "2021 Form 10-K"). In addition to historical information, the following discussion and other parts of this Quarterly Report contain forward-looking information that involves risks and uncertainties. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors. See the factors set forth under the heading “Safe Harbor Statement” at the end of this Item 2.
Overview
We are a commercial-stage pharmaceutical company. Our lead product, TPOXX® (“oral TPOXX®”, also known as "tecovirimat" in certain international markets), is an oral formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. On July 13, 2018, the United States Food & Drug Administration (“FDA”) approved oral TPOXX® for the treatment of smallpox. The Company has been delivering oral TPOXX® to the U.S. Strategic National Stockpile ("Strategic Stockpile") since 2013.
In addition to being approved by the FDA, oral TPOXX® (tecovirimat) has regulatory approval with the European Medicines Agency ("EMA"), Health Canada and the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom. The EMA and MHRA approved label indication covers the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The Health Canada approved label indication covers the treatment of smallpox.
With respect to the regulatory approvals by the EMA, MHRA and Health Canada, oral tecovirimat represents the same formulation that was approved by the FDA in July 2018 under the brand name TPOXX®.
For the intravenous formulation of TPOXX® ("IV TPOXX®"), SIGA announced on May 19, 2022 that the FDA approved this formulation for the treatment of smallpox.
Monkeypox Outbreak
Starting in June 2022, procurement orders for oral TPOXX® from new international jurisdictions, as well as orders under existing contracts, have occurred as SIGA has received ongoing inquiries about accessing oral TPOXX® in connection with a global monkeypox outbreak. The Company believes that a portion of the courses of oral TPOXX® delivered under these orders are being used for the treatment of active monkeypox cases as part of a response to this outbreak by the global health community.
Monkeypox is a disease caused by infection with the monkeypox virus. The monkeypox virus is part of the same family of viruses as smallpox. Monkeypox symptoms are similar to smallpox but are not as severe, with historical fatality in Africa of less than 1% to 10% depending on region and clade. The first human case of monkeypox was recorded in 1970. Since then, monkeypox has been reported in several central and western African countries, with case numbers greatly increasing in recent years. Prior to the ongoing 2022 outbreak, nearly all monkeypox cases in people outside of Africa were linked to international travel to countries where the disease commonly occurs, or through imported animals, including two cases in the United States in 2021. These cases are currently occurring on multiple continents. On July 23, 2022, the World Health Organization declared the monkeypox outbreak as a public health emergency of international concern. On August 4, 2022, the U.S. Government declared the monkeypox outbreak as a public health emergency.
Starting in the third quarter of 2022, in connection with the monkeypox outbreak, randomized, placebo-controlled clinical trials have been initiated in the United States, United Kingdom and Democratic Republic of Congo ("DRC") to further assess the safety and efficacy of TPOXX® in participants with monkeypox. These randomized clinical trials are now enrolling patients to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active monkeypox disease.
Study of Tecovirimat for Human Monkeypox Virus (STOMP; A5418) is a U.S.-based clinical trial sponsored by the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the National Institutes of Health. The NIAID-funded AIDS Clinical Trials Group is leading the study, which may later expand to international sites. Study investigators aim to enroll more than 500 participants, including children and those who are pregnant or breastfeeding, from clinical research sites. The trial will also include an open label arm that will include children, pregnant/breastfeeding individuals and those who are immunocompromised or have severe monkeypox disease.
PLATINUM is a U.K.-based clinical trial commissioned and funded by the National Institute for Health Care and Research. The trial is led by researchers at Oxford University and aims to recruit at least 500 participants, including children weighing ≥13 kg, across the U.K.
PALM 007 is a DRC-based clinical trial sponsored by NIAID and Institute National de Recherche Biomédicale. Study investigators aim to enroll more than 450 participants, including children weighing ≥3 kg and women who are pregnant or breastfeeding, at clinical sites in the DRC.
COVID-19 Pandemic
The COVID-19 pandemic has caused significant societal and economic disruption. The continuing direct and indirect impacts of the pandemic are significant and broad-based, including supply chain disruptions and labor shortages that started during the pandemic and continue to represent business and financial risks. As such, the Company is continually coordinating with service providers and vendors, in particular Contract Manufacturing Organizations ("CMOs") that constitute our supply chain, with respect to risks and mitigating actions.
As of the filing date of this report, the Company has not identified or been notified by government customers of impediments to the continued full performance of their government contracts. With regard to day-to-day operations, the COVID-19 pandemic, and the secondary effects of the pandemic, have at times slowed the pace of execution of government contracts as well as new contract generation. Additionally, the COVID-19 pandemic, and the secondary effects of the pandemic have increased the risk of delays in connection with a broad range of operational activities, including: supply chain procurement of raw materials and manufacturing; and certain research and development activities, such as those that involve clinical trials. Furthermore, the pandemic and related secondary effects could result in a slower pace of future product deliveries if there are shortages or delays in the receipt by the supply chain of raw materials or supplies, or if labor shortages become more acute. While the Company does not currently expect such delays to have a material adverse impact on the financial condition of the Company or its long-term operating performance, and while the COVID-19 pandemic has not adversely affected the liquidity position of the Company, the Company cannot give assurances as to the full extent of the impact at this time.
Procurement Contracts with the U.S. Government
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 a range of activities, including: advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, and procurement activities. As of September 30, 2022, 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 $268.9 million of payments are related to exercised options and up to approximately $281.9 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.
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, 2022, the Company has received $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS, $4.3 million for the delivery of IV FDP to the Strategic Stockpile and $17.1 million for other base period activities. IV BDS has been used for the manufacture of courses of IV FDP. The $3.2 million received for the completed manufacture of IV BDS had been recorded as deferred revenue as of December 31, 2021, but with the delivery of IV FDP to the Strategic Stockpile during the nine months ended September 30, 2022, $2.9 million was recognized as revenue. The remaining $0.3 million of deferred revenue will be recognized as IV FDP containing such IV BDS is delivered to the Strategic Stockpile.
The options that have been exercised to date provide for payments up to approximately $268.9 million. There are exercised options for the following activities: payments up to $11.2 million for the procurement of raw materials used in the 2020 manufacture of certain courses of oral TPOXX®; payments up to $213.9 million for the delivery of up to 726,140 courses of oral TPOXX®; payments up to $25.6 million for the manufacture of courses of IV FDP, of which $10.2 million of payments relate to 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 $14.6 million for funding of post-marketing activities for oral TPOXX®. As of September 30, 2022, the Company has received $225.1 million for the delivery (and related procurement of raw materials) of oral TPOXX® to the Strategic Stockpile; received $10.2 million for the completed manufacture of IV BDS, which has been recorded as deferred revenue as of September 30, 2022; and received or billed $8.1 million in connection with post-marketing activities for oral TPOXX®.
Unexercised options specify potential payments up to approximately $281.9 million in total (if all such options are exercised). There are options for the following activities: payments of up to $225.1 million for the delivery of oral TPOXX® to the Strategic Stockpile; payments of up to $51.2 million for the manufacture of courses of IV FDP, of which up to $20.5 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP; 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 exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option). To date, BARDA has exercised one of the three IV BDS options and one of the three IV FDP options, both of which were exercised simultaneously in 2022. If BARDA decides to only exercise the remaining IV BDS Options, then the Company would receive payments up to $20.5 million; alternatively, if BARDA decides to exercise all the remaining IV BDS Options and IV FDP Options, then the Company would receive payments up to $51.2 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. The Company estimates that sales of the IV formulation under this contract (under current terms), assuming the IV FDP Options were exercised, would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%.
Under the terms of this contract, exercise of procurement options is at the sole discretion of BARDA. The request for proposal that preceded the award of the 19C BARDA Contract indicated that the expected purpose of the contract was to maintain the level of smallpox antiviral preparedness in the Strategic Stockpile. Based on prior product delivery activity, and current FDA-approved shelf life of oral TPOXX®, the Company estimates that approximately 940,000 courses of smallpox antiviral treatment would need to be delivered to the U.S. Government between 2022 and 2024 in order to maintain stockpile levels of unexpired smallpox antiviral treatment during this period.
U.S. Department of Defense Procurement Contracts
On May 12, 2022, the Company announced a contract with the U.S. Department of Defense ("DoD") for the procurement of oral TPOXX® ("DoD Contract #1"). The DoD Contract #1 included a firm commitment for the DoD to procure approximately $3.6 million of oral TPOXX®, and an option, exercisable at the sole discretion of the DoD, for the procurement of approximately $3.8 million of oral TPOXX®. In the second quarter of 2022, the Company delivered and recognized revenue of $3.6 million for the delivery of oral TPOXX® to the DoD, fulfilling the firm commitment in DoD Contract #1. In the third quarter of 2022, the DoD exercised the option for $3.8 million of oral TPOXX® and the Company satisfied its obligation by delivering product and recognized the related revenue in September 2022.
On September 28, 2022, the Company and the DoD signed a new procurement contract ("DoD Contract #2"). The DoD Contract #2 includes a firm commitment for the DoD to procure approximately $5.2 million of oral TPOXX®, and an option, exercisable at the sole discretion of the DoD for the procurement of approximately $5.5 million of oral TPOXX®.
International Procurement Contracts
This year, through October 31, 2022, the Company has received firm commitment orders from 13 international customers (including Canada) for the delivery of approximately $77 million of oral TPOXX®, of which approximately $39 million is for Canada and approximately $38 million is for jurisdictions in Europe, Asia-Pacific, and the Middle East. Additionally, the contract with CDND (defined below) has an option until March 31, 2024, exercisable at the sole discretion of CDND, for the purchase of up to an additional $6 million of oral TPOXX®. With respect to the $77 million of firm commitment orders that have been received this year, approximately $66 million of oral TPOXX® was delivered and recorded as revenue in the nine months ended September 30, 2022, and the remaining orders are expected to be fulfilled between November 1, 2022 and July 31, 2023. Through an International Promotion Agreement (defined below), Meridian Medical Technologies, Inc. (“Meridian”) is the counterparty to international contracts under which orders are placed for the purchase of oral TPOXX®. The Public Health Agency of Canada (“PHAC”) and the Canadian Department of National Defence (“CDND”) are among the contracting parties for the purchase of oral TPOXX® (see below for a summary description of these contracts).
On January 13, 2021, PHAC awarded a contract to Meridian (the “PHAC Contract”) for the purchase of up to approximately $33 million of oral TPOXX® (tecovirimat) within five years. In March 2022 and July 2022, PHAC executed amendments in which total procurement of oral TPOXX® under the PHAC Contract was increased to an amount of approximately $45 million. Prior to 2022, approximately $10 million of oral TPOXX® had been ordered and delivered to PHAC. No courses of oral TPOXX® were delivered under this contract for the first six months of 2022. During the three months ended September 30, 2022, approximately $35 million of oral TPOXX® was delivered to PHAC and recognized as revenue. Including the deliveries in the third quarter of 2022, there are no current remaining amounts specified in the PHAC Contract.
On April 3, 2020, the Company announced that the CDND awarded a contract (the "Canadian Military Contract") to Meridian, pursuant to which the CDND would purchase up to approximately $14 million of oral TPOXX® over four years. Prior to 2022, approximately $4 million of oral TPOXX® had been ordered and delivered to CDND. No courses of oral TPOXX® were delivered under this contract for the first nine months of 2022. As of September 30, 2022, an approximate firm commitment order of $4 million remains to be delivered under this contract. Additionally, there are approximately $6 million of unexercised options, exercisable at the sole discretion of CDND, remaining under this contract.
The above-listed contract awards were 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 International Promotion Agreement, Meridian is the counterparty in connection with international contracts for oral TPOXX® and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder.
International Promotion Agreement
Under the terms of the International Promotion Agreement, Meridian was granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States (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 retains ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retains sales and marketing rights with respect to oral TPOXX®. SIGA’s consent is required for the entry into any sales arrangement pursuant to the International Promotion Agreement.
The fee Meridian retains pursuant to the International Promotion Agreement is a specified percentage of the collected proceeds of sales of oral TPOXX® net of certain expenses, for calendar years in which customer collected 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 calendar years in which such net collected amounts exceed the specified threshold. It is probable that we will exceed the specified threshold in 2022 and, as a result, the Company has recorded and will continue to record the higher specified percentage for all International Promotion Agreement sales in 2022. Taking into account Meridian’s fee and manufacturing costs of oral TPOXX®, it is currently estimated by the Company that international sales of oral TPOXX® will have a contribution margin (as expressed as a percentage of product sales, and before any consideration of expenses not directly related to manufacturing or Meridian activities) of between approximately 65% and 80%, depending on the international sales levels each year. For purposes of this disclosure, contribution margin (in amount) represents international product sales less applicable cost of sales and the Meridian fee (which is included within selling, general and administrative expenses within the income statement).
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 Part II, Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations of our 2021 Form 10-K. Our most critical accounting estimates include revenue recognition over time, the valuation of stock-based awards issued by the Company and income taxes.
Results of Operations
Three Months Ended September 30, 2022 and 2021
For the three months ended September 30, 2022, revenues from product sales and supportive services were $65.6 million. Such revenues primarily relate to international sales of oral TPOXX® of approximately $61.3 million and sales of oral TPOXX® to the DoD of approximately $3.8 million. For the three months ended September 30, 2021, revenues from product sales and supportive services were $2.3 million, which primarily relate to the acceptance of courses of oral TPOXX® delivered to CDND.
Revenues from research and development activities for the three months ended September 30, 2022 and 2021, were $6.6 million and $2.5 million, respectively. The increase of $4.1 million of revenue is primarily related to an increase in clinical trial activity under the PEP Label Expansion R&D Contract in connection with the PEP development program, as well as an increase in R&D activity under the BARDA Contract.
Cost of sales and supportive services for the three months ended September 30, 2022 and 2021 were $3.9 million and $0.1 million, respectively. Such costs in 2022 were associated with the manufacture and delivery of courses of oral TPOXX® for international sales and sales to the DoD. Such costs in 2021 were primarily associated with the manufacture and delivery of courses of oral TPOXX® to CDND.
Selling, general and administrative (“SG&A”) expenses for the three months ended September 30, 2022 and 2021 were $19.7 million and $4.5 million, respectively. The increase of approximately $15.2 million mostly reflects promotion fees incurred in connection with international sales that substantially increased from the comparable period in 2021.
Research and development (“R&D”) expenses for the three months ended September 30, 2022 and 2021 were $5.7 million and $3.2 million, respectively, reflecting an increase of approximately $2.5 million. The increase is primarily attributable to an increase in direct vendor-related expenses incurred in connection with activities under the PEP Label Expansion R&D Contract and the BARDA Contract.
Changes in the fair value of the liability-classified warrant to acquire common stock were recorded within the statement of operations. The warrant was fully exercised during the three months ended June 30, 2022. For the three months ended September 30, 2022, we recorded no activity. For the three months ended September 30, 2021, we recorded a loss of approximately $1.1 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, 2022 and 2021, we recorded pre-tax income/(loss) of $43.1 million and ($4.0) million, respectively, and a corresponding income tax (provision)/benefit of ($10.1) million and $0.9 million, respectively. The effective tax rates during the three months ended September 30, 2022 and 2021 were 23.4% and 21.9%, respectively. Our effective tax rate for the periods ended September 30, 2022 and 2021 differ from the statutory rate primarily as a result of state taxes, and non-deductible executive compensation under Internal Revenue Code Section 162(m).
Nine Months Ended September 30, 2022 and 2021
For the nine months ended September 30, 2022, revenues from product sales and supportive services were $81.6 million. Such revenues primarily relate to approximately $66.2 million of international sales of oral TPOXX®; approximately $7.5 million of oral TPOXX® sales to the DoD; and approximately $7.2 million of sales of IV TPOXX® to the U.S. Government under the 19C BARDA Contract. For the nine months ended September 30, 2021, revenues from product sales and supportive services were $12.8 million. Such revenues in 2021 primarily relate to the delivery and acceptance of courses of oral TPOXX® delivered to PHAC and CDND.
Revenues from research and development activities for the nine months ended September 30, 2022 and 2021, were $17.9 million and $5.5 million, respectively. Most of the increase of $12.4 million relates to clinical trial activity under the PEP Label Expansion R&D Contract in connection with the PEP development program, with R&D activity under the BARDA Contract also contributing to the increase.
Cost of sales and supportive services for the nine months ended September 30, 2022 and 2021 were $9.6 million and $1.3 million, respectively. The increase mostly relates to an increase in international sales of oral TPOXX® and approximately $4.4 million of cost for the manufacture and sale of IV TPOXX® in 2022; manufacturing costs per unit are higher for IV TPOXX® than oral TPOXX®.
SG&A expenses for the nine months ended September 30, 2022 and 2021 were $29.2 million and $14.1 million, respectively. The increase of approximately $15.1 million mostly reflects promotion fees incurred in connection with international sales that substantially increased from the comparable period in 2021.
R&D expenses for the nine months ended September 30, 2022 and 2021 were $16.1 million and $7.8 million, respectively. The increase of $8.3 million is mostly attributable to an increase in direct vendor-related expenses incurred in connection with activities under the PEP Label Expansion R&D Contract and the BARDA Contract.
Changes in the fair value of the liability-classified warrant to acquire common stock were recorded within the statement of operations. The warrant was fully exercised during the nine months ended September 30, 2022. For the nine months ended September 30, 2022 and 2021, we recorded a gain of approximately $0.4 million and $0.3 million, respectively, reflecting a decrease in the fair value of the liability-classified warrant primarily due to the decrease in our stock price.
For the nine months ended September 30, 2022, we recorded pre-tax income of $45.3 million and a corresponding income tax provision of ($10.5) million. For the nine months ended September 30, 2021, we recorded a pre-tax loss of ($4.6) million and a corresponding income tax benefit of $0.8 million. The effective tax rates during the nine months ended September 30, 2022 and 2021 were 23.3% and 17.7%, respectively. Our effective tax rate for the period ended September 30, 2022 differs from the statutory rate primarily as a result of state taxes and non-deductible executive compensation under Internal Revenue Code Section 162(m). Our effective tax rate for the nine months ended September 30, 2021 differs from the statutory rate primarily as a result of state taxes, non-deductible executive compensation under Internal Revenue Code Section 162(m) and a non-taxable adjustment for the fair market value of the Warrant.
Liquidity and Capital Resources
As of September 30, 2022, we had $109.7 million in cash and cash equivalents compared with $103.1 million at December 31, 2021.
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, deferred income taxes, changes in the fair value of our warrant liability, inventory write offs, gains and losses from various transactions and changes in the condensed consolidated balance sheet for working capital from the beginning to the end of the period.
Net cash provided by/(used in) operating activities for the nine months ended September 30, 2022 and 2021 was $49.7 million and ($4.6) million, respectively. For the nine months ended September 30, 2022, the receipt of approximately $80 million for product delivery and acceptance of oral TPOXX® courses delivered to the Strategic Stockpile in December 2021, as well as the receipt of approximately $23 million in connection with 2022 product deliveries and advance payments were partially offset by the payment of approximately $19 million of federal income taxes in connection with the 2021 tax year; an increase in inventory investment in connection with a broadening of the customer base for TPOXX® and mitigation of increasing general supply chain risks; and costs in relation to customary operating activities. For the nine months ended September 30, 2021, net cash usage related to support of ordinary working capital (accounts receivable, accounts payable, inventory, and prepaids, among other items) and customary operating activity was partially offset by the receipt of cash from international sales.
Investing Activities
There was no cash-related investing activity for the nine months ended September 30, 2022. For the nine months ended September 30, 2021, we used cash of $24,424 for capital expenditures.
Financing Activities
Cash used in financing activities for the nine months ended September 30, 2022 was $43.1 million, which was primarily attributable to our special cash dividend of approximately $32.9 million. In addition, we repurchased approximately 1.5 million shares of common stock for approximately $10.1 million. Cash used in financing activities for the nine months ended September 30, 2021 was $20.4 million, which was substantially all attributable to our repurchase of approximately 3.0 million shares of common stock.
On May 5, 2022, the Board of Directors declared a special dividend of $0.45 per share on the common stock of the Company, which resulted in an overall dividend payment of $32.9 million. The special dividend was paid on June 2, 2022 to shareholders of record at the close of business on May 17, 2022.
Future Cash Requirements
As of September 30, 2022, we had outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $21.8 million.
Off-Balance Sheet Arrangements
The Company does not have any off-balance sheet arrangements.
Recently Issued Accounting Standards
The Company did not adopt any accounting standards this quarter.
Safe Harbor Statement
Certain statements in this Quarterly Report on Form 10-Q, including certain statements contained in the foregoing “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Exchange Act, including statements relating to the progress of SIGA’s development programs and timelines for bringing products to market, delivering products to the Strategic Stockpile, the enforceability of our procurement contracts, such as the 19C BARDA Contract (the "BARDA Contract"), with BARDA, and responding to the global outbreak of monkeypox. 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 Contract, 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 Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract, DOD Contract #2 or PEP Label Expansion R&D Contract 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 continue 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 SIGA from 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 of disruptions to 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, (xiv) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, such as COVID-19, are ineffective and may adversely affect SIGA’s business, and (xv) risks associated with responding to the current monkeypox outbreak, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2021 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. The information contained on any website referenced in this Form 10-Q is not incorporated by reference into this filing.
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.
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, 2022. The term “disclosure controls and procedures” is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of September 30, 2022.
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, 2022 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
From time to time, we may be involved in a variety of claims, suits, investigations and proceedings arising from the ordinary course of our business, including collections claims, breach of contract claims, labor and employment claims, tax related matters and other matters. Although such claims, suits, investigations and proceedings are inherently uncertain and their results cannot be predicted with certainty, we believe that the resolution of such current pending matters, if any, will not have a material adverse effect on our business, condensed consolidated financial position, 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.
Our results of operations and financial condition are subject to numerous risks and uncertainties described in our 2021 Annual Report on Form 10-K for the fiscal year ended December 31, 2021. There have been no material changes to the risk factors described in Part I, Item 1A "Risk Factors" of our 2021 Form 10-K.
Item 2. Unregistered Sales 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 Programs |
Dollar Value of Shares That May Yet Be Purchased Under the Programs |
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| July 1, 2022 to July 31, 2022 |
- | $ | - | - | $ | 35,325,830 | ||||||||||
| August 1, 2022 to August 31, 2022 |
- | - | - | 35,325,830 | ||||||||||||
| September 1, 2022 to September 30, 2022 |
- | - | - | 35,325,830 | ||||||||||||
| - | $ | - | - | |||||||||||||
On August 5, 2021, the Company announced that the Board of Directors authorized a share repurchase program under which the Company may repurchase up to $50 million of the Company's common stock through December 31, 2023. The Company started repurchasing shares under this program in the fourth quarter of 2021. The timing and actual number of shares repurchased will depend on a variety of factors, including: the timing of procurement orders under government contracts; alternative opportunities for strategic uses of cash; the stock price of the Company’s common stock; market conditions; alternative capital management uses of cash; and other corporate liquidity requirements and priorities. No shares were repurchased in the three months ended September 30, 2022.
Item 3. Defaults upon Senior Securities
None.
Item 4. Mine Safety Disclosures
No disclosure is required pursuant to this item.
No disclosure is required pursuant to this item.
| Exhibit No. |
Description |
| 3.1 | Amended and Restated Certificate of Incorporation of SIGA Technologies, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company filed on June 16, 2022). |
| 3.2 | Amended and Restated By-laws of SIGA Technologies, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company filed on December 15, 2021). |
| 10.1† | Amendment of Solicitation/Modification of Contract 00009, dated January 27, 2022, to Agreement, dated September 10, 2018, by and between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services. |
| 10.2 | Amendment of Solicitation/Modification of Contract 00010, dated March 29, 2022, to Agreement, dated September 10, 2018, by and between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services. |
| 10.3 | Amendment of Solicitation/Modification of Contract 000011, dated July 26, 2022, to Agreement, dated September 10, 2018, by and between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services. |
| 10.4† | Amendment of Solicitation/Modification of Contract 000012, dated August 5, 2022, to Agreement, dated September 10, 2018, by and between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services. |
| 10.5† | Amendment of Solicitation/Modification of Contract 000021, dated September 28, 2022, 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. |
| 10.6 | Amendment of Solicitation/Modification of Contract 000022, dated September 29, 2022, 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. |
| Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
| Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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| Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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| Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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| 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). |
† Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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SIGA TECHNOLOGIES, INC. |
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(Registrant) |
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November 3, 2022 |
By: |
/s/ Daniel J. Luckshire |
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Daniel J. Luckshire |
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Executive Vice President and Chief Financial Officer |
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(Duly Authorized Officer, Principal Financial Officer and Principal Accounting Officer) |
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Exhibit 10.1
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY "[***]," HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT |
1. CONTRACT ID CODE |
PAGE OF PAGES |
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1 |
2 |
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2. AMENDMENT/MODIFICATION NO. P00009 |
3. EFFECTIVE DATE See Block 16C |
4. REQUISITION/PURCHASE REQ. NO. |
5. PROJECT NO. (If applicable) ASPR-21-02282
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6. ISSUED BY |
CODE |
ASPR-BARDA |
7. ADMINISTERED BY (If other than Item 6)
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CODE
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ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 |
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8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
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(x) |
9A. AMENDMENT OF SOLICITATION NO. |
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SIGA TECHNOLOGIES, INC. 1385150 Attn: Daniel Luckshire SIGA TECHNOLOGIES, INC. 31 East 62nd street NEW YORK NY 100658446 |
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9B. DATED (SEE ITEM 11)
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10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201800019C |
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CODE 1385150 |
FACILITY CODE |
10B. DATED (SEE ITEM 13) 09/10/2018 |
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11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS |
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☐ 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. |
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12. ACCOUNTING AND APPROPRIATION DATA (If required) |
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13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
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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. |
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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). |
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C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: FAR 52.243-1 Changes Fixed-Price Alt V |
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D. OTHER (Specify type of modification and authority) |
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E. IMPORTANT: Contractor ☐ is not. ☒ is required to sign this document and return 1 copies to the issuing office. |
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14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) |
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Tax ID Number: 13-3864870 |
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DUNS Number: 932651516 |
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The purpose of this No-Cost Extension (NCE) modification is to extend the delivery date of In addition, this modification revises Part 1 - The Schedule, Article G.1 - The Contracting No other changes apply.
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Continued … |
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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. |
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15A. NAME AND TITLE OF SIGNER (Type or print)
DENNIS HRUBY, CSO & EVP |
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
MONICA WATSON |
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15B. CONTRACTOR/OFFEROR |
15C. DATE SIGNED |
16B. UNITED STATES OF AMERICA |
16C. DATE SIGNED |
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| /s/ Dennis Hruby |
/s/ Monica Watson |
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(Signature of person authorized to sign) |
01/27/2022 |
(Signature of Contracting Officer) |
01/27/2022 |
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Previous edition unusable |
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STANDARD FORM 30 (REV. 11/2016) | |||||||||
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Prescribed by GSA FAR (48 CFR) 53.243 | ||||||||||
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CONTINUATION SHEET |
REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201800019C/P00009 |
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NAME OF OFFEROR OR CONTRACTOR SIGA TECHNOLOGIES, INC. 1385150 |
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SUPPLIES/SERVICES |
QUANTITY |
UNIT |
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AMOUNT |
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Discount Terms: 1/30, NET 30P
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Change Item 7 to read as follows (amount shown is the obligated amount):
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7 |
First delivery of [***] courses [***] =
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0.00 |
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Accounting Info:
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Change Item 8 to read as follows (amount shown is the obligated amount):
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Second delivery of [***] courses [***] =
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Accounting Info:
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- SNS project code: ASPR-21-02282; BARDA project codes: ASPR-20-01588 and ASPR-20-02051; PSC: AN13 NAICS: 541714 HHS/BARDA COR is Dr. Annie Xi Lu, xi.lu@hhs.gov, (202) 604-5814. |
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NSN 7540-01-152-8067 |
OPTIONAL FORM 336 (4-86) Sponsored by GSA FAR (48 CFR) 53.110 |
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Exhibit 10.2
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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT |
1. CONTRACT ID CODE |
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PAGE OF PAGES | ||||||||
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1 | 2 |
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2. AMENDMENT/MODIFICATION NO. P00010 |
3. EFFECTIVE DATE See Block 16C |
4.REQUISITION/PURCHASE REQ. NO.
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5. PROJECT NO. (If applicable) ASPR-21-02282 |
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6. ISSUED BY |
CODE |
ASPR-BARDA |
7. ADMINISTERED BY (If other than Item 6) |
CODE | |||||||
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ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201
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8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) |
(x) |
9A. AMENDMENT OF SOLICITATION NO. |
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SIGA TECHNOLOGIES, INC. 1385150 Attn: Daniel Luckshire SIGA TECHNOLOGIES, INC. 31 East 62nd street NEW YORK NY 100658446 |
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9B. DATED (SEE ITEM 11)
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10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201800019C |
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CODE 1385150 |
FACILITY CODE |
10B. DATED (SEE ITEM 13) 09/10/2018 |
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11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS |
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☐ 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. |
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12. ACCOUNTING AND APPROPRIATION DATA (If required) |
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13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
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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. |
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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). |
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C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: FAR Part 43.103(a) - Bilateral Modifications |
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D. OTHER (Specify type of modification and authority) |
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E. IMPORTANT: Contractor ☐ is not. ☒ is required to sign this document and return 1 copies to the issuing office. |
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14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) |
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Tax ID Number: 13-3864870 |
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DUNS Number: 932651516 |
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The purpose of this no cost bilateral modification is to incorporate HHSAR Clause 1. The following is hereby incorporated by full text, at no additional cost to the
HHSAR Clause 352.232-71 - Electronic Submission of Payment Requests
(a) Definitions. As used in this clause? Payment request means a bill, voucher, invoice, or request for contract financing payment |
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Continued … |
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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. |
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15A. NAME AND TITLE OF SIGNER (Type or print)
DENNIS HRUBY, CSO & EVP |
16A. NAME AND TITLE OF CONTRACTING OFFICER(Type or print)
JONATHAN F. GONZALEZ |
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15B. CONTRACTOR/OFFEROR |
15C. DATE SIGNED |
16B. UNITED STATES OF AMERICA |
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16C. DATE SIGNED | |||||||
| /s/ Dennis Hruby |
03/24/2022 |
/s/ Jonathan F. Gonzalez |
03/29/2022 | ||||||||
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(Signature of person authorized to sign) |
(Signature of Contracting Officer) |
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Previous edition unusable |
STANDARD FORM 30 (REV. 11/2016) |
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Prescribed by GSA FAR (48 CFR) 53.243
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CONTINUATION SHEET |
REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201800019C/P00010 |
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NAME OF OFFEROR OR CONTRACTOR SIGA TECHNOLOGIES, INC. 1385150 |
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SUPPLIES/SERVICES |
QUANTITY |
UNIT |
UNIT PRICE (E) |
AMOUNT (F) |
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with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ?Content of Invoices? and the applicable Payment clause included in this contract.
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(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.
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(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.
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(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.
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(End of clause)
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2. The contracting Officer is hereby changed to Jonathan Gonzalez.
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3. The total amount, scope, period of performance and all other terms and conditions of the contract remain unchanged.
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4. By signing this modification, SIGA Technologies Inc., hereby releases the Government from any and all liability under this contract for further equitable adjustments attributable to such fact or circumstance giving rise to this modification.
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END OF MODIFICATION |
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NSN 7540-01-152-8067 |
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OPTIONAL FORM 336 (4-86) Sponsored by GSA FAR (48 CFR) 53.110 |
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Exhibit 10.3
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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT |
1. CONTRACT ID CODE |
PAGE OF PAGES |
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1 |
2 |
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2. AMENDMENT/MODIFICATION NO. P00011 |
3. EFFECTIVE DATE See Block 16C |
4. REQUISITION/PURCHASE REQ. NO. |
5. PROJECT NO. (If applicable) |
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6. ISSUED BY |
CODE |
ASPR-BARDA |
7. ADMINISTERED BY (If other than Item 6) |
CODE | |||||||
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ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 |
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8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) |
(x) |
9A. AMENDMENT OF SOLICITATION NO. |
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SIGA TECHNOLOGIES, INC. 1385150 Attn: Daniel Luckshire SIGA TECHNOLOGIES, INC. 31 East 62nd street NEW YORK NY 100658446 |
9B. DATED (SEE ITEM 11) |
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x |
10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201800019C |
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CODE 1385150 |
FACILITY CODE |
10B. DATED (SEE ITEM 13) 09/10/2018 |
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11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS |
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☐ 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. |
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12. ACCOUNTING AND APPROPRIATION DATA (If required) |
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13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
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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. |
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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). |
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|
X |
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: FAR Part 43.103(a) - Bilateral Modifications |
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D. OTHER (Specify type of modification and authority) |
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|
E. IMPORTANT: Contractor ☐ is not. ☒ is required to sign this document and return 1 copies to the issuing office. |
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|
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) |
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|
Tax ID Number: 13-3864870 |
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|
DUNS Number: 932651516 |
|||||||||||
|
UEI: VJRNRTSL22K4 |
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|
The purpose of this no cost bilateral modification is to correct the payment terms that were changed via P00008. Verified invoices will be paid in full. The total amount, scope, period of performance and all other terms and conditions of the contract remain unchanged. By signing this modification, SIGA Technologies Inc., hereby releases the Government from Continued ... |
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|
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 HRUBY, CSO & EVP |
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
JONATHAN F. GONZALEZ |
||||||||||
|
15B. CONTRACTOR/OFFEROR |
15C. DATE SIGNED |
16B. UNITED STATES OF AMERICA |
16C. DATE SIGNED |
||||||||
| /s/ Dennis Hruby | 7/26/2022 |
/s/ Jonathan F. Gonzalez |
7/26/2022 |
||||||||
|
(Signature of person authorized to sign) |
|
(Signature of Contracting Officer) |
|
||||||||
|
Previous edition unusable |
STANDARD FORM 30 (REV. 11/2016) |
||||||||||
|
Prescribed by GSA FAR (48 CFR) 53.243 |
|||||||||||
|
CONTINUATION SHEET |
REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201800019C/P00011 |
|
PAGE OF | ||
|
|
|
2 | 2 | ||
|
NAME OF OFFEROR OR CONTRACTOR SIGA TECHNOLOGIES, INC. 1385150 |
|||||
|
ITEM NO |
SUPPLIES/SERVICES |
QUANTITY |
UNIT |
UNIT PRICE (E) |
AMOUNT (F) |
|
any and all liability under this contract for further equitable adjustments attributable to such fact or circumstance giving rise to this modification. |
|||||
|
Discount Terms: HHS NET 30P |
|||||
|
NSN 7540-01-152-8067 |
|
OPTIONAL FORM 336 (4-86) Sponsored by GSA FAR (48 CFR) 53.110 |
|||
Exhibit 10.4
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY "[***]," HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
|
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT |
1. CONTRACT ID CODE | PAGE OF PAGES | ||||||||||||
|
|
1 |
5 |
||||||||||||
|
2. AMENDMENT/MODIFICATION NO. P00012 |
3. EFFECTIVE DATE See Block 16C
|
4. REQUISITION/PURCHASE REQ. NO. See Schedule
|
5. PROJECT NO. (If applicable)
|
|||||||||||
|
6. ISSUED BY
|
CODE | 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. 31 East 62nd street NEW YORK NY 100658446 |
(x) |
9A. AMENDMENT OF SOLICITATION NO. |
|
|||||||||||
| 9B. DATED (SEE ITEM 11) | ||||||||||||||
| x |
10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201800019C
|
|||||||||||||
| CODE 1385150 | FACILITY CODE |
10B. DATED (SEE ITEM 13) 09/10/2018 |
|
|||||||||||
|
|
|
|||||||||||||
|
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. |
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|
12. ACCOUNTING AND APPROPRIATION DATA (If required) See Schedule |
Net Increase: $29,212,406.00 |
|||||||||||||
|
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
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|
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. | |||||||||||||
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|
||||||||||||||
| 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 Part 43.103(a) - Bilateral Modifications |
|||||||||||||
| 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 |
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|
UEI: VJRNRTSL22K4 |
||||||||||||||
|
The purpose of this bilateral modification is to exercise and fully fund Option CLINs 0008, 0013, 0015, and 0017. |
||||||||||||||
|
The total amount, scope, period of performance and all other terms and conditions of the contract remain unchanged. |
||||||||||||||
|
By signing this modification, SIGA Technologies Inc., hereby releases the Government from |
||||||||||||||
| Continued... | ||||||||||||||
|
Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect. |
||||||||||||||
|
15A. NAME AND TITLE OF SIGNER (Type or print) DENNIS HRUBY, CSO & EVP |
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) JONATHAN F. GONZALEZ |
|||||||||||||
|
15B. CONTRACTOR/OFFEROR |
15C. DATE SIGNED |
16B. UNITED STATES OF AMERICA |
|
16C. DATE SIGNED
|
|
|||||||||
|
/s/ Dennis Hruby |
Aug. 5, 2022 |
/s/ Jonathan F. Gonzalez |
|
Aug. 5, 2022 | ||||||||||
|
(Signature of person authorized to sign) |
(Signature of Contracting Officer) |
|
||||||||||||
| Previous edition unusable |
STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243 |
|||||||||||||
|
CONTINUATION SHEET |
REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201800019C/P00012 |
|
|
PAGE |
OF |
|||||||||
| 2 | 5 | |||||||||||||
|
NAME OF OFFEROR OR CONTRACTOR SIGA TECHNOLOGIES, INC. 1385150 |
||||||||||||||
|
ITEM NO. (A) |
SUPPLIES/SERVICES (B)
|
QUANTITY (C) |
UNIT (D) |
UNIT PRICE (E) |
AMOUNT (F)
|
|||||||||
|
|
any and all liability under this contract for further equitable adjustments attributable to such fact or circumstance giving rise to this modification.
|
|||||||||||||
|
Discount Terms: HHS NET 30P Period of Performance: 01/01/2020 to 09/09/2028 |
||||||||||||||
| Add Item 9 as follows: |
|
|||||||||||||
| 9 |
ASPR-22-01725 Siga Technologies -- to exercise CLIN0008 post-marketing field study for [***] |
|
3,586,806.00 |
|||||||||||
|
Accounting Info: 2022.1992126.25106 Appr. Yr.: 2022 CAN: 1992126 Object Class: 25106 Funded: $3,586,806.00 |
||||||||||||||
| Add Item 10 as follows: |
|
|||||||||||||
|
10 |
ASPR-22-01723 Siga Technologies -- to procure 64 000 TC of the Intravenous (IV) Tecovirimat as defined by CLIN0013 0015 0017 to be delivered to [***] SNS locations Per contract definition 1 TC 14 vials under contract HHSO100201800019C Obligated Amount: $25,625,600.00 Requisition No: OS299284
|
25,625,600.00 |
||||||||||||
|
Accounting Info: 2022.1992126.25103 Appr. Yr.: 2022 CAN: 1992126 Object Class: 25103 Funded: $25,625,600.00 |
|
|||||||||||||
| NSN 7540-01-152-8067 |
OPTIONAL FORM 336 (4-86) Sponsored by GSA FAR (48 CFR) 53.110 |
|||||||||||||
|
Base Period Cost Reimbursement CLIN |
||||||||
|
Item |
Period of Performance | Supplies/Services |
Estimated Cost |
Fixed Fee | Cost + Fixed Fee (CPFF) |
|||
|
0001 Base |
[***] | Late Stage development activities towards FDA approval for parenteral (IV) antiviral | [***] | [***] |
$32,009,375 |
|||
|
Total |
$30,197,522 | $1,811,853 | $32,009,375 | |||||
|
Base Period Fixed Price CLINS
|
|||||
|
Item |
Period of Performance |
Supplies/Services |
Units (# of |
Unit Price ($) |
Total ($) |
|
0002 Base |
[***] |
Initial purchase and delivery of nonparenteral (oral) formulated antiviral as final drug product (FDP) to SNS |
35,718 |
[***] |
$11,072,580 |
|
0003 Base |
[***] |
Initial procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *course = 14 vials |
20,000 |
[***] |
$3,200,000 |
|
0004 Base |
[***] |
Fill/finish of final drug product (from bulk drug substance procured under CLIN0003) |
20,000 |
[***] |
$4,800,000 |
|
0005 Base |
[***] |
Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0003) *Monthly rate/TC = [***] |
20,000 |
[***] |
[***] |
|
0006 Base |
[***] |
Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0003) |
20,000 |
[***] |
[***] |
|
Total |
|
|
|
[***] |
|
|
Optional Cost Reimbursement CLINs |
|||||
|
Item |
Period of Performance |
Supplies/Services |
Estimated Cost |
Fixed Fee |
Cost + Fixed |
|
0007 (Option) |
[***] |
Phase IV post marketing commitments (no parenteral (oral) formulation )) including [***] |
[***] |
[***] |
$40,812,609 |
|
0008 |
[***] |
Phase IV post commitments (parenteral (IV) formulation)) including [***] |
[***] |
[***] |
$3,586,806 |
|
Total |
|
|
$41,886,242 |
$2,513,173 |
[***] |
|
Optional Fixed CLINs |
|||||
|
Item |
Period of Performance |
Supplies/Services |
Treatment Courses (# of Product) |
Unit Price ($) | Total ($) |
|
0009A (Option Funded) |
1/1/19-12/31/20 |
Procurement of raw materials used in manufacturing of unmicronized API in sufficient quantity to support the production of 363,070 courses of nonparenteral (oral) formulated antiviral for SNS replenishment. Such raw materials may be forward processed. |
363,070 (raw material) |
[***] |
$11,255,170 Funded |
|
0009B (Option Funded) |
1/1/19-12/31/20 |
Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
121,023 (raw material) |
[***] |
$33,765,417 Funded |
|
0009C (Option Funded)
|
1/1/19-12/31/20 |
Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
121,023 (raw material) |
[***] |
$33,765,417 Funded |
|
0009D (Option Funded)
|
1/1/19-12/31/20 |
Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
121,024 (raw material) |
[***] |
$33,765,696 Funded |
|
0010 (Option Funded)
|
1/1/20-12/31/21 |
Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
363,070 | [***] |
$112,551,700 Funded |
|
0011 (Option)
|
[***] |
Additional procurement of a nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
363,070 | [***] | $112,551,700 |
|
0012 (Option)
|
[***] |
Additional procurement of a nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
363,072 | [***] | $112,552,320 |
|
0013 (Option)
|
[***] |
Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *course = 14 vials |
64,000 | [***] |
$10,240,000 (Funded) |
|
0014 (Option)
|
[***] |
Surge Capacity – Storage of parenteral (IV) formulated antiviral as bulk drug substance (BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0013). *Monthly rate per TC = [***] |
64,000 | [***] | [***] |
|
0015 (Option)
|
[***] |
Surge Capacity – Fill/finish of final drug product (from bulk drug substance procured under CLIN0013) |
64,000 | [***] |
$15,360,000 (Funded) |
|
0016 (Option)
|
[***] |
Surge Capacity – Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0013). *Monthly rate per TC = [***] |
64,000 | [***] | [***] |
|
0017 (Option)
|
[***] |
Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0013) *[***] SNS Shipments @ [***] |
64,000 | [***] | [***] (Funded) |
|
0018 (Option)
|
[***] |
Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *course = 14 vials |
64,000 | [***] | $10,240,000 |
|
0019 (Option)
|
[***] |
Surge Capacity – Storage of parenteral (IV) formulated antiviral as bulk drug substance (BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0018). *Monthly rate per TC = [***] |
64,000 | [***] | [***] |
|
0020 (Option)
|
[***] |
Surge Capacity – Fill/finish of final drug product from bulk drug substance procured under CLIN0018). |
64,000 | [***] | $15,360,000 |
|
0021 (Option)
|
[***] |
Surge Capacity – Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0018). *Monthly rate per TC: [***] |
64,000 | [***] | [***] |
|
0022 (Option) |
[***] |
Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0018). *[***] SNS Shipments @ [***] |
64,000 | [***] | [***] |
|
0023 (Option) |
[***] |
Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *course = 14 vials |
64,000 | [***] | $10,240,000 |
|
0024 (Option) |
[***] |
Surge Capacity – Storage of parenteral (IV) formulated antiviral as bulk drug substance (BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0023). *Monthly rate per TC = [***] |
64,000 | [***] | [***] |
|
0025 (Option) |
[***] | Surge Capacity – Fill/finish of final drug product (from bulk drug substance procured under CLIN0023). | 64,000 | [***] | $15,360,000 |
|
0026 (Option) |
[***] |
Surge Capacity – Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0023). *Monthly rate per TC: [***] |
64,000 | [***] | [***] |
|
0027 (Option) |
[***] |
Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0023). *[***] SNS Shipments @ [***] |
64,000 | [***] | [***] |
|
Total |
[***] | ||||
|
Total Funded |
|
$320,585,711 |
End of Modification P00012
Exhibit 10.5
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY "[***]," HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
|
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT |
1. CONTRACT ID CODE |
PAGE OF PAGES | ||||||||||||||||
| 1 | 3 | |||||||||||||||||
|
2. AMENDMENT/MODIFICATION NO. P00021 |
3. EFFECTIVE DATE See Block 16C |
4. REQUISITION/PURCHASE REQ. NO. OS302885 |
5. PROJECT NO. (If applicable) | |||||||||||||||
|
6. ISSUED BY |
CODE | 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 NEW YORK NY 100658014
|
(x) | 9A. AMENDMENT OF SOLICITATION NO. | ||||||||||||||||
| 9B. DATED (SEE ITEM 11) | ||||||||||||||||||
| x | 10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201100001C |
|||||||||||||||||
| CODE 1385150 | FACILITY CODE |
10B. DATED (SEE ITEM 13) 05/13/2011 |
||||||||||||||||
|
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) |
||||||||||||||||||
|
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: FAR Part 43.103(a) - Bilateral Modifications.
|
|||||||||||||||||
|
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 |
||||||||||||||||||
|
UEI: VJRNRTSL22K4 |
||||||||||||||||||
|
The purpose of this modification is to de-obligate excess funds that will cancel at the end of the fiscal year. In addition, replacement funds for those cancelling funds have been added to continue the tasks as outlined in the SOW. The period of performance is also extended until 12/31/2023. All other terms and conditions remain unchanged.
Continued ... |
||||||||||||||||||
|
Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect. |
||||||||||||||||||
|
15A. NAME AND TITLE OF SIGNER (Type or print)
Dennis Hruby, CSO & EVP |
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
JONATHAN F. GONZALEZ |
|||||||||||||||||
|
15B. CONTRACTOR/OFFEROR
|
15C. DATE SIGNED |
16B. UNITED STATES OF AMERICA |
16C. DATE SIGNED |
|||||||||||||||
| /s/ Dennis Hruby | Sept. 26, 2022 | /s/ Jonathan F. Gonzalez | Sept. 28, 2022 | |||||||||||||||
|
(Signature of person authorized to sign) |
(Signature of Contracting Officer) | |||||||||||||||||
|
Previous edition unusable |
|
STANDARD FORM 30 (REV. 11/2016) | ||||||||||||||||
|
|
Prescribed by GSA FAR (48 CFR) 53.243 |
|||||||||||||||||
|
|
||||||||||||||||||
|
CONTINUATION SHEET |
REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100001C/P00021 |
PAGE OF | ||||||||||||||||
|
|
|
2 | 3 | |||||||||||||||
|
NAME OF OFFEROR OR CONTRACTOR SIGA TECHNOLOGIES, INC. 1385150 |
||||||||||||||||||
|
ITEM NO |
SUPPLIES/SERVICES (B) |
QUANTITY |
UNIT |
UNIT PRICE |
AMOUNT |
|||||||||||||
|
Discount Terms: HHS NET 14P Period of Performance: 06/28/2016 to 12/31/2023
|
||||||||||||||||||
|
Change Item 1 to read as follows (amount shown is the obligated amount):
|
||||||||||||||||||
|
1 |
Smallpox Antiviral Drug for the Strategic National Stockpile
|
-269,641.07 |
||||||||||||||||
|
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: -$269,641.07
|
||||||||||||||||||
|
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. [***]
|
||||||||||||||||||
|
Change Item 3 to read as follows (amount shown is the obligated amount):
|
||||||||||||||||||
|
3 |
CLIN 0007 Smallpox Antiviral Drug for the - Strategic National Stockpile [***]
|
-2,336,383.03 |
||||||||||||||||
|
Accounting Info: 2013.1992002.25106 Appr. Yr.: 2013 CAN: 1992002 Object Class: 25106 Funded: $0.00
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Accounting Info: 2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103 Funded: -$1,120,983.54
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Accounting Info: 2016.1992016.25103 Appr. Yr.:2016 CAN 1992016 Object Class: 25103 Funded: $0.00
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Accounting Info: 2016.1992016.25103 Appr. Yr.:2016 CAN 1992016 Object Class: 25103 Funded: -$1,215,399.49 |
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NSN 7540-01-152-8067 |
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OPTIONAL FORM 336 (4-86) Sponsored by GSA FAR (48 CFR) 53.110 |
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CONTINUATION SHEET |
REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100001C/P00021 |
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PAGE OF | ||||
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3 | 3 | ||||
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NAME OF OFFEROR OR CONTRACTOR SIGA TECHNOLOGIES, INC. 1385150 |
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ITEM NO |
SUPPLIES/SERVICES |
QUANTITY |
UNIT |
UNIT PRICE |
AMOUNT |
||
|
No-cost time extension to comply with [***] CLIN 0007.12 Specific PoP extended to 04/22/2023 CLIN 0007.14 Specific PoP extended to 09/21/2023
|
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Change Item 5 to read as follows (amount shown is the obligated amount):
|
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|
5 |
No-cost extension of [***] PoP changed to 06/28/2016 through 12/09/2022
|
-6,189.84 |
|||||
|
Accounting Info: 2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103 Funded: -$6,189.84
|
|||||||
|
No-cost time extension for [***]
|
|||||||
|
Change Item 6 to read as follows (amount shown is the obligated amount):
|
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|
6 |
No-cost extension of CLIN 00021, [***]
|
-6,079.60 |
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|
Accounting Info: 2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103 Funded: -$6,079.60
|
|||||||
|
No-cost time extension for [***]
|
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|
Add Item 8 as follows:
|
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|
8 |
ASPR-22-02268- Additional funding to SIGA Technologies to cover the cost for completing
|
2,618,293.54 |
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|
Accounting Info: 2022.1992022.25106 Appr. Yr.: 2022 CAN: 1992022 Object Class: 25106 Funded: $2,618,293.54 |
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|
- PSC: 6505 NAICS: 541714 COR is Dr. Annie Xi Lu, (202) 604-5814, Xi.Lu@hhs.gov |
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NSN 7540-01-152-8067 |
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OPTIONAL FORM 336 (4-86) Sponsored by GSA FAR (48 CFR) 53.110 |
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Exhibit 10.6
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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT |
1. CONTRACT ID CODE |
PAGE OF PAGES | |||||||
|
|
1 | 2 |
|
||||||
|
2. AMENDMENT/MODIFICATION NO. P00022 |
3. EFFECTIVE DATE See Block 16C |
4. REQUISITION/PURCHASE REQ. NO. OS302885 |
5. PROJECT NO. (If applicable) |
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|
6. ISSUED BY |
CODE |
ASPR-BARDA |
7. ADMINISTERED BY (If other than Item 6) |
CODE | |||||
|
ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201
|
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|
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
|
(x) |
9A. AMENDMENT OF SOLICITATION NO. |
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SIGA TECHNOLOGIES, INC. 1385150 Attn: Daniel Luckshire SIGA TECHNOLOGIES, INC. 31 E 6 31 E 62ND ST NEW YORK NY 100658014 |
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|
9B. DATED (SEE ITEM 11)
|
|||||||||
|
x |
10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201100001C |
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|
CODE 1385150 |
FACILITY CODE |
10B. DATED (SEE ITEM 13) 05/13/2011 |
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11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS |
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|
☐ 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. |
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|
12. ACCOUNTING AND APPROPRIATION DATA (If required) |
Net Increase: $2,618,293.54 |
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|
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
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|
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. |
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|
X |
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). |
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|
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: |
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|
D. OTHER (Specify type of modification and authority) |
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|
E. IMPORTANT: Contractor ☒ is not. ☐ is required to sign this document and return copies to the issuing office. |
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|
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) |
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|
Tax ID Number: 13-3864870 |
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|
DUNS Number: 932651516 |
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|
UEI: VJRNRTSL22K4 |
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|
The purpose of this modification is to correct Mod 21 in the PRISM system and add funds. Mod 21 did not add funds it only de-obligated cancelling funds. All other terms and conditions remain unchanged. Discount Terms: HHS NET 14P Continued … |
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|
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. |
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|
15A. NAME AND TITLE OF SIGNER (Type or print)
Dennis E. Hruby, CSO & EVP |
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
JONATHAN F. GONZALEZ |
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|
15B. CONTRACTOR/OFFEROR
|
15C. DATE SIGNED |
16B. UNITED STATES OF AMERICA |
|
16C. DATE SIGNED | |||||
| /s/ Dennis E. Hruby | 29 Sep 2022 | /s/ Jonathan F. Gonzalez | 29 Sep 2022 | ||||||
|
(Signature of person authorized to sign) |
(Signature of Contracting Officer) |
|
|||||||
|
Previous edition unusable |
|
STANDARD FORM 30 (REV. 11/2016) | |||||||
|
|
Prescribed by GSA FAR (48 CFR) 53.243 | ||||||||
|
CONTINUATION SHEET |
REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100001C/P00022 |
|
PAGE OF | ||
|
|
2 |
2 |
|||
|
NAME OF OFFEROR OR CONTRACTOR SIGA TECHNOLOGIES, INC. 1385150 |
|||||
|
ITEM NO |
SUPPLIES/SERVICES |
QUANTITY |
UNIT (D) |
UNIT PRICE (E) |
AMOUNT (F) |
|
Appr. Yr.: 2022 CAN: 1992022 Object Class: 25106 |
|||||
|
8 |
ASPR-22-02268 – Additional funding to SIGA Technologies to cover the cost for completing tasks remaining under Contract HHSO10020110001C |
2,618,293.54 | |||
|
PSC: 6505 NAICS: 541714 COR is Dr. Annie Xi Lu, (202) 604-5814, Xi.Lu@hhs.gov |
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|
NSN 7540-01-152-8067 |
OPTIONAL FORM 336 (4-86) Sponsored by GSA FAR (48 CFR) 53.110 |
||||
Exhibit 31.1
Certification by Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
I, Phillip L. Gomez, Ph.D., certify that:
|
1. |
I have reviewed this quarterly report on Form 10-Q of SIGA Technologies, Inc.; |
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
(c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
(d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
|
Date: November 3, 2022 |
|
|
|
/s/ Phillip L. Gomez, Ph.D. |
|
Phillip L. Gomez, Ph.D. |
|
Chief Executive Officer |
Exhibit 31.2
Certification by Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
I, Daniel J. Luckshire, certify that:
|
1. |
I have reviewed this quarterly report on Form 10-Q of SIGA Technologies, Inc.; |
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
(c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
(d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
|
Date: November 3, 2022 |
|
|
|
/s/ Daniel J. Luckshire |
|
Daniel J. Luckshire |
|
Executive Vice President and Chief Financial Officer |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of SIGA Technologies, Inc. (the “Company”) on Form 10-Q for the quarterly period ended September 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Phillip L. Gomez, Ph. D., Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
|
(1) |
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
(2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
|
/s/ Phillip L. Gomez, Ph.D. |
|
Phillip L. Gomez, Ph.D. |
|
Chief Executive Officer |
|
November 3, 2022 |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of SIGA Technologies, Inc. (the “Company”) on Form 10-Q for the quarterly period ended September 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Daniel J. Luckshire, Executive Vice President and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
|
(1) |
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
(2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
|
/s/ Daniel J. Luckshire |
|
Daniel J. Luckshire |
|
Executive Vice President and Chief Financial Officer |
|
November 3, 2022 |