SIGA Technologies (SIGA) risk factors, FY2025 10-K

SIGA Technologies's FY2025 10-K, filed Mar 10, 2026, lists 38 risk factors in 7 groups. Against the prior year's 36: 4 new, 2 dropped, 11 substantially reworded.

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Risk factors listed
387 groups
New this year
4vs 36 last year
Dropped
2since the prior 10-K
Substantially reworded
11of those kept
Section length
10k wordsItem 1A

What the changes say

  • Government shutdowns and procurement dependence dominate risks to revenue from U.S. federal contracts and TPOXX.

What changed since the prior 10-K

New

  • NewRisks Related to Our Dependence on Government Contracts

    In the event of a prolonged shutdown, we may experience delays in securing new procurement contracts, which could result in reduced revenue. Even after government operations resume, it may take additional time for normal contracting activities to resume

    Prolonged government shutdowns could delay new procurement contracts and reduce future federal business opportunities for our products.

  • NewRisks Related to Regulatory Approvals

    If the CHMP recommends withdrawal of the mpox indication, and European Commission adopts the recommendation of the CHMP, it could negatively impact our anticipated revenue from Tecovirimat-SIGA and could have a material adverse effect on our business, financial condition, results of operations and growth prospects

    Withdrawal of the mpox indication recommendation by the CHMP and European Commission could negatively impact Tecovirimat-SIGA revenue.

  • NewRisks Related to Commercial and International Activities

    lawsuits, including class action suits, may be brought against us

    Lawsuits, including class action suits, may be brought against us and increase commercialization and marketing costs.

  • NewRisks Related to Our Common Stock

    Affiliates of MacAndrews & Forbes Incorporated (together with its affiliates “MacAndrews”) have substantial ownership of SIGA stock and their interests may differ from the interests of other stockholders

    MacAndrews & Forbes owns approximately 34% of our stock, limiting other stockholders' influence and potential change of control transactions.

Dropped

  • DroppedRisks Related to Commercial and International Activities

    Any of the above occurrences could harm or prevent future sales of the affected product or could increase the costs and expenses of commercializing and marketing these products, which could adversely affect our business, financial condition and results of operations

  • DroppedRisks Related to Our Common Stock

    Concentration of ownership of our capital stock could delay or prevent a change of control

Reworded

  • 86% rewrittenRisks Related to Regulatory Approvals

    Failure to maintain existing regulatory approvals or obtain future regulatory approvals in additional international jurisdictions could prevent us from marketing our products in certain jurisdictions abroad

    Added risks regarding the failure to maintain existing international regulatory approvals alongside obtaining new ones.

    Was: Failure to obtain future regulatory approval in additional international jurisdictions could prevent us from marketing our products in certain jurisdictions abroad

  • 69% rewrittenRisks Related to Our Dependence on Government Contracts

    A U.S. Government shutdown could materially adversely affect our business, results of operations, and financial condition

    Expanded on geopolitical environment, fiscal challenges, and reduced operating capacity of government agencies during shutdowns.

    Was: A U.S. Government shutdown could negatively impact our business and liquidity

  • 68% rewrittenRisks Related to Commercial and International Activities

    For contracts with international customers that were originated by Meridian in prior years and remain active, we are reliant on Meridian to collect payments from such customers, and to remit to us our share of such payments

    Removed commentary regarding expanding internal sales capabilities and reliance on Meridian for legacy international contract collections.

    Was: For contracts with international customers that were originated by Meridian in prior years and remain active, the Company is reliant on Meridian to collect payments from such customers, and to remit the Company’s share of such payment to the Company

  • 46% rewrittenRisks Related to Regulatory Approvals

    Failure to obtain regulatory approval for new formulations of TPOXX® in the U.S. would prevent us from commercializing TPOXX® in other than the oral and intravenous formulations for smallpox treatment

    Clarified that we have not received FDA approval for liquid suspension or pediatric formulations of TPOXX.

  • 42% rewrittenRisks Related to Commercial and International Activities

    If we fail to obtain recurring sales of TPOXX® to customers other than the U.S. Government, our business and opportunities for growth could be limited

    Added uncertainties regarding new tariffs, retaliatory actions, and obtaining tariff refunds on international shipping.

  • 34% rewrittenRisks Related to Commercial and International Activities

    We have incurred in the past, and could incur net losses in the future, including if we fail to enter into a new procurement contract with the U.S. Government

    Removed specific references to the 19C BARDA Contract, relying instead on potential cash flows from any new contract.

    Was: We have incurred in the past, and could incur net losses in the future, including if the remaining option is not exercised under the 19C BARDA Contract or we fail to enter into a new procurement contract with the U.S. Government

  • 34% rewrittenRisks Related to Commercial and International Activities

    We reacquired international promotional rights and we may be unable successfully to expand our internal international sales and marketing capabilities or enter into agreements with third parties outside of the U.S

    Updated to state we continue to adjust staffing and focal points for building out our international marketing organization.

    Was: We recently reacquired international promotional rights and we may be unable successfully to expand our internal international sales and marketing capabilities or enter into agreements with third parties outside of the U.S.

  • 33% rewrittenRisks Related to Commercial and International Activities

    We are subject to complex and changing laws and regulations worldwide, which exposes us to potential liability, increased cost, and other adverse effects on our business

    Added a warning that FCPA indictment alone can lead to the suspension of the right to do business with the U.S.

    Was: The Company is subject to complex and changing laws and regulations worldwide, which exposes the Company to potential liability, increased cost, and other adverse effects on the Company’s business

  • 28% rewrittenRisks Related to Commercial and International Activities

    Although TPOXX® is currently stockpiled by certain governments and not sold commercially, in the future we may be required to perform additional clinical trials or change the labeling of TPOXX® if we or others identify side effects after a product is on the market, which could harm future sales of such product

  • 26% rewrittenRisks Related to Our Common Stock

    Our business and operations would suffer in the event of a significant computer system failure, cyber-attack or deficiency in our cyber-security

  • 20% rewrittenRisks Related to Our Intellectual Property

    Our ability to compete may decrease if we do not adequately protect our intellectual property rights

All 38 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Dependence on Government Contracts

  1. 01Laws and regulations affecting government contracts and grants might make it more costly and difficult for us to successfully conduct our business
  2. 02export and import control laws and regulations, including laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data
  3. 03Unfavorable provisions in government contracts and grants, some of which may be customary, may harm our future business, financial condition and potential operating results
  4. 04control or prohibit the export of products
  5. 05A U.S. Government shutdown could materially adversely affect our business, results of operations, and financial condition69% rewritten
  6. 06In the event of a prolonged shutdown, we may experience delays in securing new procurement contracts, which could result in reduced revenue. Even after government operations resume, it may take additional time for normal contracting activities to resumeNew
  7. 07Our business could be adversely affected by a negative audit by the U.S. Government

Risks Related to Regulatory Approvals

  1. 08Failure to obtain regulatory approval for new formulations of TPOXX® in the U.S. would prevent us from commercializing TPOXX® in other than the oral and intravenous formulations for smallpox treatment46% rewritten
  2. 09Failure to maintain existing regulatory approvals or obtain future regulatory approvals in additional international jurisdictions could prevent us from marketing our products in certain jurisdictions abroad86% rewritten
  3. 10If the CHMP recommends withdrawal of the mpox indication, and European Commission adopts the recommendation of the CHMP, it could negatively impact our anticipated revenue from Tecovirimat-SIGA and could have a material adverse effect on our business, financial condition, results of operations and growth prospectsNew

Risks Related to Commercial and International Activities

  1. 11Changing political or social factors and opposition, such as protests and potential related litigation, may delay or impair our ability to market TPOXX® and any other biodefense product candidates and may require us to spend time and money to address these issues
  2. 12Our ability to grow our business partly depends on our ability to achieve recurring sales of TPOXX® to customers other than the U.S. Government, which may increase our exposure to risks associated with conducting business in international markets
  3. 13If we fail to obtain recurring sales of TPOXX® to customers other than the U.S. Government, our business and opportunities for growth could be limited42% rewritten
  4. 14increased management and infrastructure costs
  5. 15We reacquired international promotional rights and we may be unable successfully to expand our internal international sales and marketing capabilities or enter into agreements with third parties outside of the U.S34% rewritten
  6. 16For contracts with international customers that were originated by Meridian in prior years and remain active, we are reliant on Meridian to collect payments from such customers, and to remit to us our share of such payments68% rewritten
  7. 17Although TPOXX® is currently stockpiled by certain governments and not sold commercially, in the future we may be required to perform additional clinical trials or change the labeling of TPOXX® if we or others identify side effects after a product is on the market, which could harm future sales of such product28% rewritten
  8. 18lawsuits, including class action suits, may be brought against usNew
  9. 19We are subject to complex and changing laws and regulations worldwide, which exposes us to potential liability, increased cost, and other adverse effects on our business33% rewritten
  10. 20We have incurred in the past, and could incur net losses in the future, including if we fail to enter into a new procurement contract with the U.S. Government34% rewritten

Risks Related to Manufacturing, Storage and Our Dependence on Third Parties

  1. 21If third parties on whom we rely for packaging and delivery of our products, are unable to meet the target timing for deliveries to our customers, product revenue recognition may be delayed and our business could suffer
  2. 22Problems related to large-scale commercial manufacturing could cause an increase in costs or shortages of products or a delay in product launches

Risks Related to Product Development

  1. 23acceptance of the product or new indication/formulation by potential government customers, public health experts, physicians, patients, healthcare payers and others in the medical community
  2. 24We may not be able to fully commercialize the liquid suspension/pediatric formulation of TPOXX®, or additional indications for TPOXX®, if our clinical trials do not demonstrate adequate safety or our animal studies do not demonstrate adequate efficacy
  3. 25Liquid Suspension/Pediatric TPOXX® formulations are currently in product development and there can be no assurance of successful development or ultimate commercialization
  4. 26achieve customer acceptance

Risks Related to Our Intellectual Property

  1. 27Our ability to compete may decrease if we do not adequately protect our intellectual property rights20% rewritten
  2. 28If our patents are challenged and found to be invalid or unenforceable, the value of our products could be harmed, and we could be subject to competition earlier than we anticipated

Risks Related to Our Common Stock

  1. 29Affiliates of MacAndrews & Forbes Incorporated (together with its affiliates “MacAndrews”) have substantial ownership of SIGA stock and their interests may differ from the interests of other stockholdersNew
  2. 30A future issuance of preferred stock may adversely affect the rights of the holders of our common stock
  3. 31Global infectious disease outbreaks, such as the COVID-19 pandemic, or climate-related matters could negatively impact the global economy on a broad scale and our business in particular
  4. 32Future acquisitions, strategic investments, partnerships or alliances could be difficult to identify and integrate, divert the attention of management, disrupt our business, dilute stockholder value, materially change the risk profile of the Company and/or adversely affect our operating results and financial condition
  5. 33The health security markets in which we compete and will compete are highly competitive
  6. 34Product liability lawsuits could cause us to incur liabilities, which could be substantial, and require us to limit commercialization of any products that we may develop
  7. 35Our activities may involve hazardous materials, use of which may subject us to environmental regulatory liabilities
  8. 36The loss of key personnel or our ability to recruit or retain qualified personnel could adversely affect our results of operations
  9. 37Our business and operations would suffer in the event of a significant computer system failure, cyber-attack or deficiency in our cyber-security26% rewritten
  10. 38We may need additional funding, which may not be available to us, and which may force us to delay, reduce or limit proposed acquisitions or strategic investments or any of our non-government funded product development programs or commercial efforts

Other SIGA Technologies 10-Ks

  • FY2024 10-K risk factors
    36 risks

    Heavy reliance on U.S. Government contracts like BARDA for TPOXX revenues creates significant concentration risk. International expansion faces hurdles in regulatory approvals and managing third-party partners like Meridian. Intellectual property protection and complex global compliance are vital for future growth.

    Filed Mar 11, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.