Siga Technologies Inc 10-Q for FY2025 Q1
Siga Technologies Inc (SIGA)
About this 10-Q
Siga Technologies Inc filed this 10-Q on May 8, 2025, covering the quarter ended March 31, 2025 (FY2025 Q1).
Headline figures
Quarter ended March 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $7.04M
- down 72.3% from $25.43M a year earlier
- Net loss
- $408.22K
- compared with net income of $10.28M a year earlier
- Diluted EPS
- -$0.01
- compared with $0.14 a year earlier
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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| | 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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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 |
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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 April 17, 2025, the registrant had outstanding
SIGA TECHNOLOGIES, INC.
FORM 10-Q
Table of Contents
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| 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)
| March 31, 2025 | December 31, 2024 | |||||||
| 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 tax asset, net | ||||||||
| Goodwill | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses and other current liabilities | ||||||||
| Deferred IV TPOXX® revenue | ||||||||
| Income tax payable | ||||||||
| Total current liabilities | ||||||||
| Other liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Common stock ($ par value, shares authorized, and , issued and outstanding at March 31, 2025 and December 31, 2024, 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 March 31, |
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| 2025 |
2024 |
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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 (loss)/income |
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| Other income, net |
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| (Loss)/Income before income taxes |
( |
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| Benefit/(Provision) for income taxes |
( |
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| Net and comprehensive (loss)/income |
$ | ( |
) | $ | ||||
| Basic (loss)/income per share |
$ | ( |
) | $ | ||||
| Diluted (loss)/income 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)
| Three Months Ended March 31, |
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| 2025 |
2024 |
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| Cash flows from operating activities: |
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| Net (loss)/income |
$ | ( |
) | $ | ||||
| Adjustments to reconcile net (loss)/income to net cash used in operating activities: |
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| Depreciation and other amortization |
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| Stock-based compensation |
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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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| 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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| 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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| Issuance of 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 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, 2024, included in the Company's 2024 Annual Report on Form 10-K filed on March 11, 2025 (the "2024 Form 10-K"). All terms used but not defined elsewhere herein have the meaning ascribed to them in the 2024 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 2024 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 months ended March 31, 2025, 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. As of March 31, 2025, the Company's active contractual performance obligations consist of the following: performance obligations relate to research and development services; and
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. A portion of the Company's revenue is derived from long-term contracts that span multiple years. 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. The Company accounts for shipping and handling activities as fulfillment costs rather than as an additional promised service.
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 March 31, 2025, the accounts receivable balance in the condensed balance sheet includes approximately $
Recent Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, may be applied prospectively or retrospectively, and allows for early adoption. These requirements are not expected to have an impact on our consolidated financial statements, but will impact our income tax disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, requiring public entities to disclose additional information about specific expense categories in the notes to the consolidated financial statements on an interim and annual basis. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and for interim periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2024-03.
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 as of March 31, 2025, provide for payments up to approximately $
Unexercised options, as of March 31, 2025, 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 had the sole discretion to choose to exercise any, all, or none of these options. The 19C BARDA Contract included: 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 March 31, 2025 and 2024, the Company recognized revenues of $
U.S. Department of Defense Procurement Contracts
In 2024, the Company had sales of approximately $
International Sales Activity
In the three months ended March 31, 2025, the Company had international sales of $
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 months ended March 31, 2025 and 2024, the Company recognized $
International Promotion Agreement
Under the terms of the current International Promotion Agreement, which was amended on March 27, 2024, and effective June 1, 2024, and further amended on August 30, 2024, the Company has primary responsibility for the advertising, promotion and sale of oral TPOXX® in all geographic regions. Meridian has limited, non-exclusive rights to advertise, promote, offer for sale and sell oral TPOXX® in the European Economic Area, Australia, Japan, Switzerland, the United Kingdom and the Association of Southeast Asian Nations and its member states (collectively, the “Current Territory”). Meridian also performs non-promotional activities under specified contracts with third parties entered into prior to June 1, 2024, that provide for the sale of oral TPOXX® in the Current Territory. The International Promotion Agreement entitles Meridian to receive a fee equal to a high single digit percentage of collected proceeds (whether collected by Meridian or the Company), net of certain expenses, of sales of oral TPOXX® in the Current Territory in the field of use specified in the International Promotion Agreement. The International Promotion Agreement has a fixed term that expires on May 31, 2026, with no automatic renewal.
Under the terms of the original International Promotion Agreement (“Pre-amendment International Promotion Agreement”), which had an initial term that expired on May 31, 2024, Meridian had been 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 agreed not to commercialize any competing product, as defined in the Pre-amendment International Promotion Agreement, in the specified field of use in the Territory. Under the Pre-amendment International Promotion Agreement, as well as the current International Promotion Agreement, SIGA has always retained ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retained sales and marketing rights with respect to oral TPOXX®. SIGA’s consent is required prior to the entry by Meridian into any sales arrangement pursuant to the International Promotion Agreement.
Sales to international customers pursuant to the Pre-amendment International Promotion Agreement were invoiced and collected by Meridian, and such collections were remitted, less Meridian’s fees, to the Company under a quarterly process specified in the Pre-amendment International Promotion Agreement; and Meridian was entitled to 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 were less than or equal to a specified threshold, and to a higher specified percentage of such collected net proceeds for calendar years in which such net collected amounts exceeded the specified threshold. Subsequent to June 1, 2024, only specified procurement contracts for the Current Territory entered into prior to June 1, 2024, continue to involve Meridian invoicing and collecting proceeds, and retaining a fee pursuant to the International Promotion Agreement.
Inventory includes costs related to the manufacture of TPOXX®. Inventory consisted of the following:
| As of | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| Raw materials | $ | $ | ||||||
| Work in-process | ||||||||
| Finished goods | ||||||||
| Inventory | $ | $ | ||||||
During the three months ended March 31, 2025, the Company recovered approximately $
5. Property, Plant and Equipment
Property, plant and equipment consisted of the following:
| As of | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| 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 | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| Inventory | $ | $ | ||||||
| Other | ||||||||
| Professional fees | ||||||||
| Compensation | ||||||||
| Lease liability, current portion | ||||||||
| Research and development vendor costs | ||||||||
| Accrued expenses and other current liabilities | $ | $ | ||||||
7. Fair Value of Financial Instruments
The carrying value of cash and 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.
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
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 earnings per share computation:
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Net (loss)/income for basic earnings per share | $ | ( | ) | $ | ||||
| Weighted-average shares | ||||||||
| Effect of potential common shares | ||||||||
| Weighted-average shares: diluted | ||||||||
| (Loss)/Income per share: basic | $ | ( | ) | $ | ||||
| (Loss)/Income per share: diluted | $ | ( | ) | $ | ||||
For the three months ended March 31, 2024, weighted-average diluted shares include the dilutive effect of in-the-money options and stock-settled RSUs. The dilutive effect of 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 months ended March 31, 2024 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 months ended March 31, 2024, the weighted average number of shares under the cash-settled RSUs excluded from the calculation of diluted earnings per share was
For the three months ended March 31, 2025, the Company incurred a loss and as a result, the equity instruments listed below were excluded from the calculation of diluted 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 March 31, | ||||
| 2025 | ||||
| Stock options | | |||
| Restricted stock units (1) | |
(1) For the three months ended March 31, 2025, the total excludes a weighted average of
9. 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 March 31, 2025, the Company had approximately $
10. Related Party Transactions
Real Estate Leases
On May 26, 2017, the Company and MacAndrews & Forbes Incorporated ("M&F") entered into a ten-year Office Lease agreement (the "New HQ Lease"), pursuant to which the Company agreed to lease
Board of Directors and Outside Consultant
Effective June 13, 2023, an individual was elected to the Company's Board of Directors who was already providing and continued to provide consulting services to the Company. Under a consulting agreement, the director received a monthly fee of $
11. Segment and Geographic Information
The Company operates in single operating and reportable segment, which includes all activities related to the sale of the Company’s oral and IV TPOXX® as well as research and development services. The Company derives revenue primarily from sales to the U.S. Government as well as international governments (including government affiliated entities) and manages the business activities on a consolidated basis. The segment derives revenues from customers through the delivery of product and fulfillment of research and development services.
The Chief Operating Decision Maker ("CODM") assesses performance for the segment and decides how to allocate resources based on net income that also is reported on the income statement as consolidated net income. Consolidated net income is also a measure that is considered in monitoring budget versus actual results.
The CODM does not review assets in evaluating the results of the segment, and therefore, such information is not presented.
The following table provides the operating result of the Company's segment:
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenue | ||||||||
| Product sales and supportive services | $ | $ | ||||||
| Research and development | ||||||||
| Total revenues | $ | |||||||
| Less: | ||||||||
| Cost of sales and supportive services | ||||||||
| Employee expenses | ||||||||
| R&D vendor expenses | ||||||||
| Professional fee expenses | ||||||||
| International promotion fees | ||||||||
| Other segment items (1) | ||||||||
| Interest income | ( | ) | ( | ) | ||||
| (Benefit)/Provision for income taxes | ( | ) | ||||||
| Net (loss)/income | $ | ( | ) | $ | ||||
(1) Other segment items include insurance, regulatory and consultant expenses, as well as various general corporate costs.
Revenues by geographic region were as follows:
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| United States | $ | $ | ||||||
| International | ||||||||
| Canada | ||||||||
| Europe, Middle East and Africa (EMEA) | ||||||||
| Total International | ||||||||
| 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 March 31, 2025 and 2024, we recorded pre-tax (loss)/income of ($
The effective tax rate for the three months ended March 31, 2025 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.
Effective beginning in fiscal 2022, the U.S. Tax Cuts and Job Act of 2017 ("TCJA") requires the Company to deduct U.S. and international research and development expenditures ("R&D") for tax purposes over 5 to 15 years, instead of in the current fiscal year. The Company concurrently records a deferred tax benefit for the future amortization of the research and development for tax purposes. The requirement to expense R&D as incurred is unchanged for U.S. GAAP purposes and the impact to pre-tax R&D expense is not affected by this provision.
The tables below present changes in stockholders' equity for the three months ended March 31, 2025 and 2024.
| Common Stock | Additional Paid-in | Accumulated | Other Comprehensive | Total Stockholders' | ||||||||||||||||||||
| Shares | Amount | Capital | Deficit | Income | Equity | |||||||||||||||||||
| Balances at December 31, 2024 | $ | $ | $ | ( | ) | $ | $ | |||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||||||
| Payment of common stock tendered for employee stock-based compensation tax obligations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||
| Issuance of common stock upon vesting of RSUs | ( | ) | ||||||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||||||
| Balances at March 31, 2025 | $ | $ | $ | ( | ) | $ | $ | |||||||||||||||||
| Common Stock | Additional Paid-in | Accumulated | Other Comprehensive | Total Stockholders' | ||||||||||||||||||||
| Shares | Amount | Capital | Deficit | Income | Equity | |||||||||||||||||||
| Balances at December 31, 2023 | $ | $ | $ | ( | ) | $ | $ | |||||||||||||||||
| Net income | — | |||||||||||||||||||||||
| Issuance of common stock | ( | ) | ( | ) | ||||||||||||||||||||
| Cash dividend ($0.60 per share) | — | ( | ) | ( | ) | |||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||||||
| Balances at March 31, 2024 | $ | $ | $ | ( | ) | $ | $ | |||||||||||||||||
The Company leases its Corvallis, Oregon, 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 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 the second quarter of 2024, the Company entered into an additional addendum, which extended the lease expiration date to December 31, 2026. In connection with this additional addendum, 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 New 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 March 31, 2025 are expected to be as follows:
| 2025 | $ | |||
| 2026 | ||||
| 2027 | ||||
| Total undiscounted cash flows under leases | ||||
| Less: Imputed interest | ( | ) | ||
| Present value of lease liabilities | $ |
As of March 31, 2025, approximately $
On
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 11, 2025 (the "2024 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 “Forward-Looking Statements” at the end of this Item 2 and in Item 1A. Risk Factors of the 2024 Form 10-K.
Overview
SIGA Technologies, Inc. (“SIGA” or the “Company”) is a commercial-stage pharmaceutical company. The Company sells its lead product, TPOXX® (“oral TPOXX®,” also known as "tecovirimat," "Tecovirimat-SIGA," or "TEPOXX (tecovirimat)" in certain international markets), to the U.S. Government and international governments (including government affiliated entities). In certain international markets, the Company may sell TPOXX® through a distributor. Additionally, the Company sells the intravenous formulation of TPOXX® ("IV TPOXX®") to the U.S. Government.
TPOXX® is an antiviral drug for the treatment of human smallpox disease caused by variola virus. On July 13, 2018, the United States Food & Drug Administration (“FDA”) approved oral TPOXX® for the treatment of smallpox. The Company has been delivering oral TPOXX® to the U.S. Strategic National Stockpile ("Strategic Stockpile") since 2013.
On May 18, 2022, the FDA approved IV TPOXX® for the treatment of smallpox.
In addition to being approved by the FDA, oral TPOXX® (tecovirimat) has received regulatory approval from the European Medicines Agency ("EMA"), Health Canada, the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom, and most recently, in December 2024, the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA"). The EMA, MHRA and PMDA approved oral TPOXX® for the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against smallpox. Health Canada approved TPOXX® for the treatment of smallpox.
With respect to the regulatory approvals by the EMA, PMDA, MHRA and Health Canada, oral tecovirimat represents the same formulation approved by the FDA in July 2018 under the brand name TPOXX®.
In connection with a potential FDA label expansion of oral TPOXX® for an indication covering smallpox post-exposure prophylaxis (“PEP”), the Company has completed an immunogenicity trial and an expanded safety trial. The timing of a potential submission of a supplemental New Drug Application to the FDA (“Supplemental NDA”) for a smallpox PEP indication for oral TPOXX® will be based on the results of ongoing sample analyses from the immunogenicity trial; the Company is currently targeting a Supplemental NDA submission in the next twelve months.
Macroeconomic Environment
Future macroeconomic volatility, including changes to tariffs and trade policies, could cause cost increases resulting in an adverse effect on the Company’s operating results. The Company’s supply chain was designed to lessen the impact of macroeconomic volatility such as through development of a U.S. domestic supply chain including U.S. production of API and finished product, and minimal reliance on ex-U.S. components for API and oral TPOXX®.
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 Strategic Stockpile, and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of IV TPOXX®. In October 2023, the contract was modified so that a course of IV TPOXX® was redefined within the contract from being 14 vials to being 28 vials; as such, the 19C BARDA Contract currently specifies 106,000 courses of IV TPOXX® (for the same payment amount as originally specified). In addition to the delivery of TPOXX® courses, 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®, development of a pediatric formulation, and procurement activities. On March 26, 2025, an option for the procurement of $25.6 million of IV TPOXX® was exercised by BARDA, increasing cumulative exercised options to $545.2 million and reducing the amount of unexercised options to $5.6 million. As of March 31, 2025, 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, approximately $545.2 million of payments are related to exercised options and up to approximately $5.6 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. On April 8, 2025, total payments contemplated under the contract with BARDA were increased by $14.3 million to $616.8 million when the contract was modified to add funding for activities supporting manufacturing.
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 10,000 courses (as currently defined within the contract as being 28 vials) 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 reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities. As of March 31, 2025, the Company had 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, $4.8 million for the delivery of IV FDP to the Strategic Stockpile and $26.3 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 2022, $2.9 million was recognized as revenue. The remaining $0.3 million of deferred revenue was recognized in the second quarter of 2024 as the IV FDP containing such IV BDS was delivered to and accepted by the Strategic Stockpile.
The options that have been exercised as of March 31, 2025, provide for payments up to approximately $545.2 million. As of March 31, 2025, there are exercised options for the following activities: payments up to $450.2 million for the manufacture and delivery of up to 1.5 million courses of oral TPOXX®; payments up to $76.8 million for the manufacture of courses 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 March 31, 2025, a cumulative total of $396.9 million of oral TPOXX® has been delivered to the Strategic Stockpile and accepted; a cumulative total of $35.7 million of IV BDS or IV FDP has been either set aside in inventory or delivered to the Strategic Stockpile and accepted (IV BDS that has been set aside has been recorded as deferred revenue and will be recognized as revenue when the IV BDS is manufactured as IV FDP and delivered); and the Company has been cumulatively reimbursed $9.7 million in connection with post-marketing activities for oral and IV TPOXX®. In April 2025, approximately $53 million of oral TPOXX® and approximately $9 million of IV TPOXX® (including recognition of deferred revenue) was delivered to the Strategic Stockpile.
Unexercised options, as of March 31, 2025, specify potential payments up to approximately $5.6 million in total (if all such options are exercised), of which approximately $5.6 million relates to supportive activities that we currently do not expect to be required.
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 had the sole discretion to choose to exercise any, all, or none of these options. The 19C BARDA Contract included: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 32,000 courses (as currently defined within the contract) of IV TPOXX®; and three separate IV FDP Options, each providing for 32,000 courses of final drug product of IV TPOXX®. BARDA had 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 all three IV BDS options and all three IV FDP options. The Company estimates that sales of the IV formulation under this contract (under current terms), would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%.
U.S. Department of Defense Procurement Contracts
In 2024, the Company had sales of approximately $10 million to the U.S. Department of Defense ("DoD") of which approximately $1.1 million was delivered in the first quarter of 2024. Sales consisted mostly of delivery of oral TPOXX®, with a minor amount of IV TPOXX® delivered.
International Sales Activity
In the three months ended March 31, 2025, the Company had international sales of $5.8 million, consisting of a delivery of oral TPOXX® to one country. In the three months ended March 31, 2024, the Company had international sales, including shipping revenue, of $8.0 million consisting of a delivery of oral TPOXX® to eight countries. International sales in the three months ended March 31, 2024, were made under the International Promotion Agreement (defined and discussed below) with Meridian Medical Technologies, LLC ("Meridian"). Through the International Promotion Agreement, Meridian was the counterparty to the international contracts under which sales were made during the three months ended March 31, 2024.
International Promotion Agreement
Under the terms of the current International Promotion Agreement, which was amended on March 27, 2024 and effective June 1, 2024, and further amended on August 30, 2024, the Company has primary responsibility for the advertising, promotion and sale of oral TPOXX® in all geographic regions. Meridian has limited, non-exclusive rights to advertise, promote, offer for sale and sell oral TPOXX® in the European Economic Area, Australia, Japan, Switzerland, the United Kingdom and the Association of Southeast Asian Nations and its member states (collectively, the “Current Territory”). Meridian also performs non-promotional activities under specified contracts with third parties entered into prior to June 1, 2024, that provide for the sale of oral TPOXX® in the Current Territory. The International Promotion Agreement entitles Meridian to receive a fee equal to a high single digit percentage of collected proceeds (whether collected by Meridian or the Company), net of certain expenses, of sales of oral TPOXX® in the Current Territory in the field of use specified in the International Promotion Agreement. The International Promotion Agreement has a fixed term that expires on May 31, 2026, with no automatic renewal.
Under the terms of the original International Promotion Agreement (“Pre-amendment International Promotion Agreement”), which had an initial term that expired on May 31, 2024, Meridian had been 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 agreed not to commercialize any competing product, as defined in the Pre-amendment International Promotion Agreement, in the specified field of use in the Territory. Under the Pre-amendment International Promotion Agreement, as well as the current International Promotion Agreement, SIGA has always retained ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retained sales and marketing rights with respect to oral TPOXX®. SIGA’s consent is required prior to the entry by Meridian into any sales arrangement pursuant to the International Promotion Agreement.
Sales to international customers pursuant to the Pre-amendment International Promotion Agreement were invoiced and collected by Meridian, and such collections were remitted, less Meridian’s fees, to the Company under a quarterly process specified in the Pre-amendment International Promotion Agreement; and Meridian was entitled to 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 were less than or equal to a specified threshold, and to a higher specified percentage of such collected net proceeds for calendar years in which such net collected amounts exceeded the specified threshold. Subsequent to June 1, 2024, only specified procurement contracts for the Current Territory entered into prior to June 1, 2024, continue to involve Meridian invoicing and collecting proceeds, and retaining a fee pursuant to the International Promotion Agreement.
Mpox
In connection with the 2022 response to a global mpox outbreak, a series of observational and randomized, placebo-controlled clinical trials were initiated to assess the safety and efficacy of TPOXX® in participants with mpox. The purpose of these randomized clinical trials is to seek to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease. As of March 31, 2025, two of the randomized, placebo-controlled clinical trials reported preliminary topline results: a randomized, placebo-controlled clinical trial in the Democratic Republic of the Congo ("DRC") known as PALM 007 (Tecovirimat for Treatment of Monkeypox Virus - NCT05559099), which is funded and sponsored by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID); and the Study of Tecovirimat for Human Mpox Virus (STOMP) clinical trial (NCT05534984), which is a randomized, placebo-controlled, double-blind study sponsored and funded by NIAID to evaluate the safety and efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive mpox disease that included enrollees from Argentina, Brazil, Japan, Mexico, Peru, Thailand, and the United States. The PALM 007 study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the DRC with mpox who received TPOXX® compared to patients who received placebo. Some improvement versus placebo was observed in patients receiving TPOXX® whose symptoms began seven days or fewer before randomization and patients with severe or grave disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions, however the significance of these data have not been established. An interim analysis of data from the STOMP study showed that TPOXX® did not demonstrate efficacy in time to skin and mucosal lesion resolution compared to placebo in patients with mild to moderate clade II mpox. Based on this result and additional analyses, the study Data Safety and Monitoring Board (DSMB) recommended to stop enrolling patients in the randomized arms of the study. NIAID accepted this recommendation and subsequently decided to take a similar action in the open label arm of this study, which included severe and at-risk of developing severe disease patients. Data analysis is not yet complete for primary endpoint subgroups and detailed secondary and exploratory endpoints. In both studies, TPOXX® exhibited a safety profile comparable to placebo. These safety results are consistent with prior studies and further support the strong safety profile that has been observed with tecovirimat over the past 15 years.
Three randomized clinical trials, UNITY (Switzerland, Brazil, Argentina), Platinum-CAN (Canada), and EPOXI (EU), are enrolling mpox patients. Given the STOMP and PALM007 results and the design similarities across these mpox trials, the Company believes these ongoing trials are likely to yield similar results.
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 2024 Form 10-K. Our most critical accounting estimate is revenue recognition over time.
Results of Operations
The recently implemented U.S. tariffs, and subsequently implemented retaliatory tariffs, did not materially impact our first quarter results. While the long-term effects remain uncertain, we continue to closely monitor the evolving tariff policy environment which presents a mix of impacts, with the potential for higher product and operating costs.
Three Months Ended March 31, 2025 and 2024
For the three months ended March 31, 2025, revenues from product sales and supportive services were $5.8 million. Such revenues include $5.8 million of Oral TPOXX® sales to one international country. For the three months ended March 31, 2024, revenues from product sales and supportive services were $23.9 million. Such revenues include $14.7 million of oral TPOXX® sales to the U.S. Government under the 19C BARDA Contract, $7.6 million of oral TPOXX® international sales and approximately $1.1 million of oral TPOXX® sales to the DoD.
Revenues from research and development activities for the three months ended March 31, 2025 and 2024, were $1.2 million and $1.6 million, respectively. The revenues for the three months ended March 31, 2025, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The revenues for the three months ended March 31, 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The decrease of $0.4 million of revenue is primarily related to a decrease in billable activities under the 19C BARDA Contract.
Cost of sales and supportive services for the three months ended March 31, 2025 and 2024 were $0.2 million and $3.2 million, respectively. Such costs in 2025 were associated with the manufacture and delivery of courses of oral TPOXX® partially offset by a recovery for inventory previously written off. Such costs in 2024 were associated with the manufacture and delivery of courses of oral TPOXX® to the U.S. Government under the 19C BARDA Contract, to multiple international countries and the DoD.
Selling, general and administrative (“SG&A”) expenses for the three months ended March 31, 2025 and 2024 were $5.7 million and $7.9 million, respectively. The decrease of approximately $2.2 million primarily reflects the decrease in international promotion fees due to the decrease in international sales in 2025 in comparison to the same period in 2024, as well as lower compensation expense associated with the nonrecurrence in 2025 of certain one-time payments and equity grants that occurred in 2024 in connection with new hires.
Research and development (“R&D”) expenses for the three months ended March 31, 2025 and 2024 were $3.5 million and $3.1 million, respectively, reflecting an increase of approximately $0.4 million. The increase is primarily attributable to the implementation of information technology enhancements, higher compensation expense in connection with an increase in headcount, and an increase in the usage of regulatory consultants.
Other income, net for the three months ended March 31, 2025 and 2024 were $1.7 million and $1.9 million, respectively. These amounts reflect interest income earned on cash and cash equivalents.
For the three months ended March 31, 2025 and 2024, we recorded a pre-tax loss of ($0.6) million and a pre-tax income of $13.2 million, respectively, and a corresponding income tax benefit/(provision) of $0.2 million and ($2.9) million, respectively. The effective tax rates during the three months ended March 31, 2025 and 2024 were 28.4% and 22.2%, respectively. Our effective tax rates for the periods ended March 31, 2025 and 2024 differ from the statutory rate primarily as a result of state taxes and non-deductible executive compensation under Internal Revenue Code Section 162(m).
Liquidity and Capital Resources
As of March 31, 2025, we had $162.3 million in cash and cash equivalents, compared with $155.4 million at December 31, 2024. We believe that our liquidity and capital resources will be sufficient to meet our anticipated requirements for at least the next twelve months from the issuance of these financial statements.
Operating Activities
We prepare our condensed consolidated statement of cash flows using the indirect method. Under this method, we reconcile net income to cash flows from operating activities by adjusting net income for those items that impact net income 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, 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 three months ended March 31, 2025 and 2024 was $7.1 million and ($6.1) million, respectively. For the three months ended March 31, 2025, the receipt of approximately $20 million from sales of TPOXX® to the U.S. Government and an international customer, all of which was from accounts receivable at December 31, 2024, as well as the receipt of investment income on cash and cash equivalents, was partially offset by the payment of approximately $8 million of income taxes as well as for the use of cash (net of research development revenues) for inventory and customary operating activities. For the three months ended March 31, 2024, the receipt of approximately $25 million from sales of oral TPOXX® to the U.S. Government, of which approximately $15 million relates to first quarter 2024 sales and the remainder to accounts receivable at December 31, 2023, was offset by payment of $21.8 million of income taxes as well as for the use of cash for customary operating activities.
Investing Activities
There was minimal (less than $25,000) cash-related investing activities for the three months ended March 31, 2025 and no cash-related investing activities for the three months ended March 31, 2024.
Financing Activities
Cash used in financing activities for each of the three months ended March 31, 2025 and 2024 was $0.2 million, which was attributable to the payment of tax obligations in connection with stock issued to employees.
Future Cash Requirements
As of March 31, 2025, we had outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $11.8 million.
On April 8, 2025, the Board of Directors declared a special cash dividend of $0.60 per share on the common stock of the Company. The special cash dividend is payable on May 15, 2025, to shareholders of record at the close of business on April 29, 2025.
Recently Issued Accounting Standards
For discussion regarding the impact of accounting standards that were recently issued but are not yet effective, on our condensed consolidated financial statements, see Note 2, Summary of Significant Accounting Policies, to the condensed consolidated financial statements.
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks, uncertainties, and assumptions. All statements contained in this Quarterly Report on Form 10-Q other than statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “seek,” “anticipate,” “could,” “should,” “target,” “goal,” “potential” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. 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 SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (ii) the risk that the BARDA Contract or U.S. Department of Defense contracts are modified or canceled at the request or requirement of, or SIGA is not able to enter into new contracts to supply TPOXX® to, the U.S. Government, (iii) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX® internationally, (iv) 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, (v) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (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, on SIGA’s businesses, (xiii) the impacts of significant recent shifts in trade policies, including the imposition of tariffs, retaliatory tariff measures, and subsequent modifications or suspensions thereof, and market reactions to such policies and resulting trade disputes, (xiv) 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, (xv) risks associated with actions or uncertainties surrounding the debt ceiling or the changes in the U.S. administration, and (xvi) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, are ineffective and may adversely affect SIGA’s business, 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, 2024 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 objective is 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 March 31, 2025. 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 March 31, 2025.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting during the quarter ended March 31, 2025, 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 2024 Annual Report on Form 10-K for the fiscal year ended December 31, 2024. There have been no material changes to the risk factors described in Part I, Item 1A "Risk Factors" of our 2024 Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults upon Senior Securities
None.
Item 4. Mine Safety Disclosures
No disclosure is required pursuant to this item.
of the Company's directors or officers adopted, modified or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the Company's quarter ended March 31, 2025, as such terms are defined under Item 408(a) of Regulation S-K.
| 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 13, 2024). |
| 10.1† | Amendment of Solicitation/Modification of Contract 00017, dated March 26, 2025, 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 00018, dated April 8, 2025, 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. |
| Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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| 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). |
* Indicates management contract or compensatory plan.
† Portions of this exhibit have been omitted pursuant to Item 601(b)(2)(ii) or 601(b)(10)(iv) of Regulation S-K, as applicable.
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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| Date: |
May 8, 2025 |
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
CERTAIN INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY "[***]," HAS BEEN OMITTED BECAUSE IT IS BOTH (1) 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 | 8 | ||||||
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2. AMENDMENT/MODIFICATION NO. P00017 |
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3. EFFECTIVE DATE See Block 16C |
4. REQUISITION/PURCHASE REQ. NO. ASP339751 |
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)
SIGA TECHNOLOGIES, INC. 1385150 Attn: DANIEL J. LUCKSHIRE SIGA TECHNOLOGIES, INC. 31, EA 31, EAST 62ND STREET NEW YORK NY 10065 |
(x) |
9A. AMENDMENT OF SOLICITATION NO. |
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9B. DATED (SEE ITEM 11) |
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10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201800019C
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10B. DATED (SEE ITEM 13) 09/10/2018 |
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CODE 1385150 |
FACILITY CODE |
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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) See Schedule |
Net Increase: | $25,625,600.00 | ||||||
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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: |
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X |
D. OTHER (Specify type of modification and authority) FAR 43.103(a) Modification by mutual agreement of the parties. |
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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.) Tax ID Number: 13-3864870 UEI: VJRNRTSL22K4 The purpose of this modification is to exercise and fully fund Option CLIN 0023, 0025, 0027, update Article G.4 Key Personnel, and update Article I.1 Federal Acquisition Regulations (FAR) (48 CFR Chapter 1) Clauses in accordance with Class Deviation (CD) No. 2025-01 from the Federal Acquisition Regulation (FAR) regarding Executive Order (EO) 14172 and EO. 14168 (CAAC Letter 2025.01 Supplement 1). The total contract funded amount is increased by $25,625,600 from [***] to [***].
All other terms and conditions remain unchanged. OTA: N 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. |
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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) AUDREY A. GLOVER |
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15B. CONTRACTOR/OFFEROR |
15C. DATE SIGNED
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16B. UNITED STATES OF AMERICA |
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16C. DATE SIGNED
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| /s/ Dennis E. Hruby, CSO & EVP | March 25, 2025 | /s/ Audrey A. Glover | March 26, 2025 | |||||
| (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 | ||||||||
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CONTINUATION SHEET |
REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201800019C/P00017 |
PAGE OF | ||||
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2 | 8 | |||
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NAME OF OFFEROR OR CONTRACTOR SIGA TECHNOLOGIES, INC. 1385150 |
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ITEM NO. (A) |
SUPPLIES/SERVICES (B) |
QUANTITY (C) |
UNIT (D) |
UNIT PRICE (E) |
AMOUNT (F) |
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Discount Terms: HHS NET 30P Period of Performance: 01/01/2020 to 09/09/2028
Add Item 18 as follows:
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18 |
CLIN0023 - Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) * TC = [***] vials Period of Performance: [***] Obligated Amount: $10,240,000.00
Accounting Info: 2025.Q99BS25.26039 Appr. Yr.: 2025 CAN: Q99BS25 Object Class: 26039 Funded: $10,240,000.00
Add Item 19 as follows:
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10,240,000.00 |
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19 |
CLIN0025 - Surge Capacity Fill/finish final drug product (from bulk drug substance procured under CLIN0023) Period of Performance: [***] Obligated Amount: $15,360,000.00
Accounting Info: 2025.Q99BS25.26088 Appr. Yr.: 2025 CAN: Q99BS25 Object Class: 26088 Funded: $15,360,000.00
Add Item 20 as follows:
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15,360,000.00 |
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20 |
CLIN0027 - Surge Capacity - Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0023) Period of Performance: [***] Obligated Amount: [***]
Accounting Info: 2025.Q99BS25.22006 Appr. Yr.: 2025 CAN: Q99BS25 Object Class: 22006 Funded: [***]
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[***] | ||||
| NSN 7540-01-152-8067 |
OPTIONAL FORM 336 (4-86) Sponsored by GSA FAR (48 CFR) 53.110 |
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Base Period Cost Reimbursement CLIN |
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Item |
Period of |
Supplies/Services |
Estimated Cost |
Fixed Fee |
Cost + Fixed |
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0001 Base |
[***] |
Late-Stage development activities toward FDA approval for parenteral (IV) antiviral |
[***] | [***] | [***] |
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Total (CLIN0001) |
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[***] | [***] | [***] |
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Base Period Fixed CLINs |
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Item |
Period of Performance |
Supplies/Services |
Unit (# of Doses or Dose Equivalents) |
Unit Price ($) |
Total ($) |
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0002 Base |
[***] |
Initial purchase and delivery of nonparenteral (oral) formulated antiviral as final drug product (FDP) to SNS |
[***] | [***] | [***] |
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0003 Base |
[***] |
Initial procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC = 28 vials |
[***] | [***] | [***] |
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0004 Base |
[***] |
Fill/finish of final drug product (from bulk drug substance procured under CLIN0003) |
[***] | [***] | [***] |
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0005 Base |
[***] |
Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0003) *Monthly rate TC = [***] |
[***] | [***] | [***] |
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0006 Base |
[***] |
Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0003 and Process Validation lot manufactured under CLIN0001) |
[***] | [***] | [***] |
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Total (CLINs 0002-0006) |
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[***] | ||
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Optional Cost Reimbursement CLINs |
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Item |
Period of Performance |
Supplies/Services |
Estimated Cost |
Fixed Fee |
Cost + Fixed Fee (CPFF) |
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0007 (Option Funded) |
[***] |
Phase IV post-marketing commitments (nonparenteral (oral) formulation)) including [***] |
[***] | [***] |
$14,612,790 (Funded) |
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0008 (Option Funded) |
[***] |
Phase IV Post Marketing commitments (parenteral (IV) formulation)) including [***] |
[***] | [***] |
$3,586,806 (Funded) |
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Total (CLINs 0007-0008) |
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[***] | [***] | [***] |
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Optional Fixed CLINs |
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Item |
Period of Performance |
Supplies/Services |
Treatment Courses (# of Product) |
Unit Price ($) |
Total ($) |
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0009A (Option Funded) |
[***] |
Procurement of raw materials used in manufacturing of unmicronized API in sufficient quantity to support the production of [***] courses of nonparenteral (oral) formulated antiviral for SNS replenishment. Such raw materials may be forward processed. |
363,070 (raw material) |
[***] |
$11,255,170 (Funded) |
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0009B (Option Funded) |
[***] |
Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
121,023 (raw material) |
[***] |
$33,765,417 (Funded) |
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0009C (Option Funded) |
[***] |
Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
121,023 (raw material) |
[***] |
$33,765,417 (Funded) |
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0009D (Option Funded) |
[***] |
Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
121,024 (raw material) |
[***] |
$33,765,696 (Funded) |
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0010 (Option Funded) |
[***] |
Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
363,070 |
[***] |
$112,551,700 (Funded) |
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0011 (Option) |
[***] |
Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
363,070 |
[***] |
$112,551,700 (Funded) |
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0012 (Option Funded) |
[***] |
Additional procurement of a nonparenteral (oral) formulated antiviral as FDP and delivery to SNS |
363,072 |
[***] |
$112,552,320 (Funded) |
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0013 (Option Funded) |
[***] |
Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC = [***] vials |
32,000 |
[***] |
$10,240,000 (Funded) |
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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 = [***] |
32,000 |
[***] | [***] |
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0015 (Option Funded) |
[***] |
Surge Capacity Fill/finish of final drug product (from bulk drug substance procured under CLIN0013) |
32,000 |
[***] |
$15,360,000 (Funded) |
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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 = [***] |
32,000 |
[***] | [***] |
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0017 (Option Funded) |
[***] |
Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0013) |
32,000 |
[***] | [***] |
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0018 (Option Funded) |
[***] |
Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC = [***] vials |
32,000 |
[***] |
$10,240,000 (Funded) |
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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 = [***] |
32,000 |
[***] | [***] |
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0020 (Option Funded) |
[***] |
Surge Capacity Fill/finish of final drug product from bulk drug substance procured under CLIN0018) |
32,000 |
[***] |
$15,360,000 (Funded) |
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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 = [***] |
32,000 |
[***] | [***] |
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0022 (Option Funded) |
[***] |
Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0018). |
32,000 |
[***] |
[***] (Funded) |
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0023 (Option Funded) |
[***] |
Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC= [***] vials |
32,000 |
[***] |
$10,240,000 (Funded) |
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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 = [***] |
32,000 |
[***] | [***] |
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0025 (Option Funded) |
[***] |
Surge Capacity Fill/finish of final drug product (from bulk drug substance procured under CLIN0023) |
32,000 |
[***] |
$15,360,000 |
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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: [***] |
32,000 |
[***] | [***] |
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0027 (Option) |
[***] |
Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0023) |
32,000 |
[***] |
[***] (Funded) |
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Total (CLINs 0009A – 0027) |
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[***] |
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Total Contract Value |
[***] | ||||
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Total Funded |
[***] | ||||
ARTICLE G.4 KEY PERSONNEL is deleted and replaced as follows:
The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty (30) days' notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.
The following individual(s) is/are considered to be essential to the work being performed hereunder:
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Name |
Functional Area |
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Dennis Hruby, Executive Vice President – Chief Scientific Officer |
Principal Investigator |
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Emily Blum, Director, Clinical Development |
Clinical Development Lead |
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Kristin Murray, Senior Vice President, Regulatory and Quality |
Quality Assurance Lead |
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Tove' Bolken, Senior Vice President, Chief Supply Chain Officer |
Supply Chain Lead |
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Paul Long, Senior Director, Regulatory Affairs |
Regulatory Lead |
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Kady Honeychurch, Director, Project Management |
Program Management |
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George Wong, Vice President, Drug Development and Technical Operations |
Manufacturing Lead |
| [***] |
Pharmacovigilance Lead |
ARTICLE I.1 FEDERAL ACQUISITION REGULATIONS (FAR) (48 CFR CHAPTER 1) CLAUSES
In accordance with Class Deviation (CD) No. 2025-01 from the Federal Acquisition Regulation (FAR) Regarding Executive Order (EO) 14173 and EO. 14168. (CAAC Letter 2025.01 Supplement 1), the following clauses shall be removed and added to this Contract and enforced if applicable:
Removed:
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52.222-21 Prohibition of Segregated Facilities |
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52.222-26 Equal Opportunity |
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52.222-29 Notification of Visa Denial |
Added (Enforced if applicable):
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52.204-8, Annual Representations and Certifications (JAN 2025) (DEVIATION FEB 2025) |
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52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services (MAY 2024) (DEVIATION FEB 2025) |
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52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services (JAN 2025) (DEVIATION FEB 2025) |
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52.213-4, Terms and Conditions—Simplified Acquisitions (Other Than Commercial Products and Commercial Services) (JAN 2025) (DEVIATION FEB 2025) |
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52.222-6 Construction Wage Rate Requirements (AUG 2018) (DEVIATION FEB 2025) |
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52.222-9 Apprentices and Trainees (JULY 2005) |
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52.222-11 Subcontracts (Labor Standards) (MAY 2014) (DEVIATION FEB 2025) |
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52.222-12 Contract Termination—Debarment (MAY 2014) (DEVIATION FEB 2025) |
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52.244-6, Subcontracts for Commercial Products and Commercial Services (JAN 2025) (DEVIATION FEB 2025) |
All other terms and conditions of this contract remain unchanged and in full force and effect.
END OF MODIFICATION P00017 to HHSO100201800019C
Exhibit 10.2
CERTAIN INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY "[***]," HAS BEEN OMITTED BECAUSE IT IS BOTH (1) NOT MATERIAL AND (II) THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
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1. CONTRACT ID CODE | PAGE OF PAGES | ||||||||
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1 | 11 | |||||||
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2. AMENDMENT/MODIFICATION NO. P00018 |
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3. EFFECTIVE DATE See Block 16C |
4. REQUISITION/PURCHASE REQ. NO. ASP340063 |
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)
SIGA TECHNOLOGIES, INC. 1385150 Attn: DANIEL J. LUCKSHIRE SIGA TECHNOLOGIES, INC. 31, EA 31, EAST 62ND STREET NEW YORK NY 10065
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(x) |
9A. AMENDMENT OF SOLICITATION NO.
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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) 2025.Q99BS25.25106 |
Net Increase: | $14,324,736.00 | ||||||||
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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: |
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X |
D. OTHER (Specify type of modification and authority) FAR 43.103(a) Modification by mutual agreement of the parties. |
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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.) Tax ID Number: 13-3864870 UEI: VJRNRTSL22K4 The purpose of this modification is to provide supplemental funding to CLIN0001 for the technical transfer of Intravenous Tecovirimat to a new Contract Development and Manufacturing Organization (CDMO), update Section B - Supplies or Services and Prices/Costs, Article B.2 Base Period, and update Section J - List of Attachments, Attachment 2, Statement of Work dated October 29, 2024. The total obligated amount is increased by $14,324,736 to [***] from [***].
All other terms and conditions remain unchanged. OTA: N 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. |
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15A. NAME AND TITLE OF SIGNER (Type or print)
Dennis Hruby |
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16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
AUDREY A. GLOVER |
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15B. CONTRACTOR/OFFEROR |
15C. DATE SIGNED |
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16B. UNITED STATES OF AMERICA
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16C. DATE SIGNED | ||||||
| /s/ Dennis Hruby | /s/ Audrey A. Glover | |||||||||
| (Signature of person authorized to sign) | April 8, 2025 | (Signature of Contracting Officer) | April 8, 2025 | |||||||
| 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/P00018 |
PAGE OF |
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2 |
11 |
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NAME OF OFFEROR OR CONTRACTOR SIGA TECHNOLOGIES, INC. 1385150 |
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ITEM NO. (A) |
SUPPLIES/SERVICES (B) |
QUANTITY (C) |
UNIT (D) |
UNIT PRICE (E) |
AMOUNT (F) |
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Discount Terms: HHS NET 30P Appr. Yr.: 2025 CAN: Q99BS25 Object Class: 25106 Period of Performance: 01/01/2020 to 09/08/2028
Add Item 21 as follows:
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21 |
ASPR-25-00789 Base CLIN0001 Additional funding to base periods to support tech transfer of their IV manufacturing to a new CDMO Period of Performance: 9/9/2024-9/8/2028 Obligated Amount: $14,324,736.00 |
14,324,736.00 |
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| NSN 7540-01-152-8067 |
OPTIONAL FORM 336 (4-86) Sponsored by GSA FAR (48 CFR) 53.110 |
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Section B – Supplies or Services and Prices/Costs
Article B.2 Base Period is deleted and replaced as follows:
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Base Period Cost Reimbursement CLIN |
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|
Item |
Period of |
Supplies/Services |
Estimated Cost |
Fixed Fee |
Cost + Fixed |
|
0001 Base |
[***] |
Late-Stage development activities toward FDA approval for parenteral (IV) antiviral |
[***] |
[***] |
[***]
|
|
Total (CLIN0001) |
[***] |
[***] |
[***] |
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Base Period Fixed CLINs |
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|
Item |
Period of Performance |
Supplies/Services |
Unit (# of Doses or Dose Equivalents) |
Unit Price ($) |
Total ($) |
|
0002 Base |
[***] |
Initial purchase and delivery of nonparenteral (oral) formulated antiviral as final drug product (FDP) to SNS |
[***] | [***] | [***] |
|
0003 Base |
[***] |
Initial procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC = 28 vials |
[***] | [***] | [***] |
|
0004 Base |
[***] |
Fill/finish of final drug product (from bulk drug substance procured under CLIN0003) |
[***] | [***] | [***] |
|
0005 Base |
[***] |
Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0003) *Monthly rate TC= [***] |
[***] | [***] | [***] |
|
0006 Base |
[***] |
Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0003 and Process Validation lot manufactured under CLIN0001) |
[***] | [***] | [***] |
|
Total (CLINs 0002-0006) |
|
|
|
|
[***] |
|
Optional Cost Reimbursement CLINs |
|||||
|
Item |
Period of Performance |
Supplies/Services |
Estimated Cost |
Fixed Fee |
Cost + Fixed Fee (CPFF) |
|
0007 (Option Funded) |
[***] |
Phase IV post-marketing commitments (nonparenteral (oral) formulation)) including [***] |
[***] | [***] |
$14,612,790 (Funded) |
|
0008 (Option Funded) |
[***] |
Phase IV Post Marketing commitments (parenteral (IV) formulation)) including [***] |
[***] | [***] |
$3,586,806 (Funded) |
|
Total (CLINs 0007-0008) |
|
|
[***] |
[***] |
[***] |
|
Optional Fixed CLINs |
|||||
|
Item |
Period of Performance |
Supplies/Services |
Treatment Courses (# of Product) |
Unit Price ($) |
Total ($) |
|
0009A (Option Funded) |
[***] |
Procurement of raw materials used in manufacturing of unmicronized API in sufficient quantity to support the production of [***] 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) |
[***] |
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) |
[***] |
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) |
[***] |
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) |
[***] |
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 nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS |
363,070 |
[***] |
$112,551,700 (Funded) |
|
0012 (Option Funded) |
[***] |
Additional procurement of a nonparenteral (oral) formulated antiviral as FDP and delivery to SNS |
363,072 |
[***] |
$112,552,320 (Funded) |
|
0013 (Option Funded) |
[***] |
Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC = [***] vials |
32,000 |
[***] |
$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 = [***] |
32,000 |
[***] | [***] |
|
0015 (Option Funded) |
[***] |
Surge Capacity Fill/finish of final drug product (from bulk drug substance procured under CLIN0013) |
32,000 |
[***] |
$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 = [***] |
32,000 |
[***] | [***] |
|
0017 (Option Funded) |
[***] |
Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0013) |
32,000 |
[***] | [***] |
|
0018 (Option Funded) |
[***] |
Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC = [***] vials |
32,000 |
[***] |
$10,240,000 (Funded) |
|
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 = [***] |
32,000 |
[***] | [***] |
|
0020 (Option Funded) |
[***] |
Surge Capacity Fill/finish of final drug product from bulk drug substance procured under CLIN0018) |
32,000 |
[***] |
$15,360,000 (Funded) |
|
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 = [***] |
32,000 |
[***] | [***] |
|
0022 (Option Funded) |
[***] |
Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0018). |
32,000 |
[***] |
[***] (Funded) |
|
0023 |
[***] |
Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC = [***] vials |
32,000 |
[***] |
$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 = [***] |
32,000 |
[***] | [***] |
|
0025 |
[***] |
Surge Capacity Fill/finish of final drug product (from bulk drug substance procured under CLIN0023) |
32,000 |
[***] |
$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: [***] |
32,000 |
[***] | [***] |
|
0027 |
[***] |
Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0023). |
32,000 |
[***] | [***] |
|
Total (CLINs 0009A – 0027) |
|
|
|
|
[***] |
|
Total Contract Value |
[***] |
||||
|
Total Funded |
[***] |
||||
Section J – List of Attachments, Attachment 2, Statement of Work is deleted and replaced as follows:
[***]
All other terms and conditions of this contract remain unchanged and in full force and effect.
END OF MODIFICATION P00018 to HHSO100201800019C
Exhibit 31.1
Certification by Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
I, Diem Nguyen, 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: May 8, 2025 |
|
|
|
/s/ Diem Nguyen, Ph.D. |
|
Diem Nguyen, 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: May 8, 2025 |
|
|
|
/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 March 31, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Diem Nguyen, 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/ Diem Nguyen, Ph.D. |
| Diem Nguyen, Ph.D. |
|
Chief Executive Officer |
|
May 8, 2025 |
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 March 31, 2025 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 |
|
May 8, 2025 |