What changed in this filing

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Item 1A. Risk Factors

2022-03-03 compared with 2021-03-04 · 91 added, 85 removed, 317 unchanged (36% of the section changed)

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Government contracts require ongoing funding decisions by governments.

A substantial percentage of potential contract revenues would come from the 19C BARDA Contract, and the majority of the potential revenue under the 19C BARDA Contract is tied to options which may or may not be exercised at the sole discretion of BARDA.

A substantial percentage of our potential contract revenues would come from the 19C BARDA Contract, and the majority of the potential revenue under the 19C BARDA Contract is tied to options which may or may not be exercised at the sole discretion of BARDA.

Reduced or discontinued BARDA funding, or the non-exercise of contract options under the 19C BARDA Contract, could cause our business, financial condition, results of operations and prospects to suffer materially.

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Our government customers are subject to political considerations and budgetary constraints, which result in uncertainties as to continued funding of their ongoing programs, including SIGA’s contracts.

More than 90% of remaining contract value of the 19C BARDA Contract is tied to options exercisable in the sole discretion of BARDA. There is no guarantee that any of the remaining options will be exercised, or if they are exercised when such exercise of options will occur.

More than 90% of remaining contract value of the 19C BARDA Contract is tied to options exercisable in the sole discretion of BARDA. There is no guarantee that any of the remaining options will be exercised, or if they are exercised when such exercise of options will occur.

If some of these options are not exercised, because levels of government expenditures and authorizations for biodefense decrease or shift to other programs, or for any other reason, our business, financial condition, results of operations and prospects may suffer materially.

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We expect that our future contracts with the U.S.

Government and foreign governments for TPOXX®

as well as contracts for other biodefense product candidates would also be fixed-price arrangements.

Government and foreign governments for TPOXX®, as well as contracts for other biodefense product candidates, would also be fixed-price arrangements.

Under a fixed-price contract, we are required to deliver our products at a fixed price determined at the inception of the contract regardless of the actual costs we incur, and to absorb any costs incurred in satisfaction of our obligations.

Our failure to anticipate technical problems, estimate costs accurately or control costs during performance of a fixed-price contract could reduce the profitability of such contract or cause a loss, which could in turn negatively affect our operating results.

Our failure to anticipate significant technical problems, estimate costs accurately or control costs during performance of a fixed-price contract could reduce the profitability of such contract, or if severe, cause a loss, which could in turn negatively affect our operating results.

We expect future operating revenues to come significantly from contracts with BARDA for the provision and maintenance of the U.S.

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Laws and regulations affecting government contracts and grants might make it more costly and difficult for us to successfully conduct our business.

Our business with the U.S.

Federal Government, and any future business with state and local governmental agencies are subject to specific procurement regulations and a variety of other legal and compliance obligations.

Our business with the U.S. Government, and any future business with state and local governmental agencies are subject to specific procurement regulations and a variety of other legal and compliance obligations.

These laws and rules include those related to procurement integrity, rates and pricing of services and goods to be reimbursed by the U.S.

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the business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act and the Foreign Corrupt Practices Act;

export and import control laws and regulations;

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.

export 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.

Compliance with these obligations increases our performance and compliance costs.

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Any cost found to be improperly allocated to a specific contract will not be reimbursed, and such costs already reimbursed must be refunded.

If an audit uncovers improper or illegal activities, we may be subject to civil and criminal penalties and administrative sanctions, including termination of contracts, forfeiture of profits, suspension of payments, fines and suspension, debarment or prohibition from doing business with the U.S.

If an audit uncovers improper or illegal activities, a contractor may be subject to civil and criminal penalties and administrative sanctions, including termination of contracts, forfeiture of profits, suspension of payments, fines and suspension, debarment or prohibition from doing business with the U.S.

Government. 

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may prevent us from fully commercializing TPOXX®

in the United States other than through existing sales to BARDA and may impact other regulatory authorities' review of TPOXX®, which in turn, could adversely impact commercializing TPOXX®

in other countries, and such delays or required alterations to regulatory applications could also have a material adverse effect on the Company.

Failure to obtain regulatory approval in international jurisdictions could prevent us from marketing our products abroad.

To market our products in Canada, the European Union and certain other foreign jurisdictions, we may need to obtain separate regulatory approvals and comply with numerous and varying regulatory requirements.

in the United States other than through existing sales to BARDA and may impact other regulatory authorities' future review of expanded formulations or indications of TPOXX®, which in turn, could adversely impact commercializing TPOXX®

in other countries, and such delays or required alterations to regulatory applications could also have a material adverse effect on future revenue opportunities for the Company.

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

To market our products in certain additional foreign jurisdictions, we may need to obtain separate regulatory approvals and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries and can involve additional testing and differing manufacturing or labeling requirements.

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The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval for expanded indications or new formulations of TPOXX®.

We may not obtain foreign regulatory approvals on a timely basis, if at all.

Regulatory approval by the FDA, which we obtained for oral TPOXX®, or by a foreign regulatory authority such as Canada or the European Medicines Agency (EMA) does not ensure approval by regulatory authorities in other foreign countries or jurisdictions or by the FDA for expanded indications or new formulations.

We may not obtain additional foreign regulatory approvals on a timely basis, if at all.

Regulatory approval by the FDA, which we obtained for oral TPOXX®, or by a foreign regulatory authority such as Health Canada and the European Medicines Agency, which we obtained for oral TPOXX®, does not ensure approval by future additional regulatory authorities in other foreign countries or jurisdictions or by the FDA for expanded indications or new formulations.

In addition, failure to obtain approval in one jurisdiction may impact our ability to obtain approvals elsewhere.

We may not be able to file for or receive necessary regulatory approvals to commercialize our products in any non-U.S.

market, in which case, our target market may be reduced and our ability to realize the full market potential of our product candidates may be harmed and our business, financial condition, results of operations and prospects may be adversely affected.

We may not be able to file for or receive necessary regulatory approvals to commercialize our products in additional new markets, in which case, our target market may be reduced and our ability to realize the full market potential of our product candidates may be harmed and our business, financial condition, results of operations and prospects may be adversely affected.

Risks Related to Commercial Activities

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 other than the oral formulation for smallpox treatment.

We have only received FDA approval for the oral formulation of TPOXX®, not the intravenous or liquid suspension/pediatric formulation, or any other indication beyond treatment for smallpox, for TPOXX®. Because pharmaceutical manufacturers are only permitted to commercialize indications and formulations that have received FDA approval (or in other jurisdictions according to their applicable regulatory and legal frameworks), any regulatory or legal setbacks as described above could have an adverse impact on the Company’s ability to sell other formulations or for other uses of TPOXX®

We have received FDA approval only for the oral formulation of TPOXX®

in the U.S., not the intravenous or liquid suspension/pediatric formulation, or any other indication beyond treatment for smallpox, for TPOXX®. Because pharmaceutical manufacturers are only permitted to commercialize indications and formulations that have received FDA approval (or in other jurisdictions according to their applicable regulatory and legal frameworks), any regulatory or legal setbacks as described above could have an adverse impact on the Company’s ability to sell other formulations or for other uses of TPOXX®

pending such approvals.

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and any other biodefense product candidates and may require us to spend time and money to address these issues.

Products developed to treat diseases caused by or to combat the threat of bioterrorism or biowarfare will be subject to changing political and social environments.

Products developed to treat diseases caused by or to combat the threat of bioterrorism or biowarfare are subject to changing political and social environments.

The political and social responses to bioterrorism and biowarfare have been unpredictable and much debated.

Changes in the perception of the risk that military personnel or civilians could be exposed to biological agents as weapons of bioterrorism or biowarfare may delay or cause resistance to bringing investigational products to market or limit pricing or purchases of approved products, any of which could materially harm our business.

Lawsuits, publicity campaigns or other negative publicity may adversely affect the degree of market acceptance of, and thereby limit the demand for, TPOXX®

Lawsuits, protests or other negative publicity may adversely affect the degree of market acceptance of, and thereby limit the demand for, TPOXX®

and our biodefense product candidates.

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to customers other than the U.S.

and Canadian governments.

An element of our business strategy is to sell TPOXX®

internationally to foreign governments, as well as to customers other than the U.S.

and Canadian governments.

These potential non-U.S.

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to customers other than the U.S.

Government, our business and opportunities for growth could be limited.

and Canadian governments, our business and opportunities for growth could be limited.

We expect our future international revenues to depend heavily on the success of the efforts of Meridian pursuant to an International Promotion Agreement, which may not be successful. 

Pursuant to the International Promotion Agreement described under “Business," we granted a third party, Meridian Medical Technologies, a division of Pfizer, exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX®

Pursuant to the International Promotion Agreement described under “Business,”

we granted a third party, Meridian Medical Technologies ("Meridian") exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX®

in all geographic regions except for the United States (the “Territory”), and Meridian agreed not to commercialize any competing product, as defined in the International Promotion Agreement, in the specified field of use in the Territory. 

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If we are unable to expand our internal sales and marketing capabilities or enter into agreements with third parties with expertise in sales and marketing, we may be unable to expand our sales of TPOXX®

or other product candidates in the U.S., including to 

or other product candidates in the U.S., including to U.S.

customers other than the U.S.

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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.

If we obtain the necessary marketing approval to sell TPOXX ®

to non-government customers and are able to charge higher prices than we do to the U.S.

Government , healthcare reform and controls on healthcare spending may nonetheless limit the price we charge for our products and the amounts that we can sell.

There have been a number of legislative and regulatory proposals in the United States to change the health care system in ways that could affect pricing if we seek to sell TPOXX®

If we sell TPOXX ®

to non-government customers and are able to charge such customers higher prices than we charge to the U.S.

Government , healthcare reform and controls on healthcare spending in the U.S.

may nonetheless limit the prices we charge for our products and the amounts that we can sell.

There have been a number of legislative and regulatory proposals in the United States to change the health care system in ways that could affect our pricing of TPOXX®

to non-government customers.

One enacted proposal, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “Healthcare Reform Act”), substantially changed the way healthcare is financed by both governmental and private insurers and had a substantial effect on the pharmaceutical industry.

The Healthcare Reform Act contains a number of provisions, including those governing enrollment in federal healthcare programs like Medicare, reimbursement changes and rules protecting against fraud and abuse that will affect existing healthcare programs.

If we obtain marketing approval for sale of TPOXX®

beyond the U.S.

government customers and are able to charge higher prices than we do to the U.S.

Government, healthcare reform and controls on healthcare spending may nonetheless limit the price we charge for our products and the amounts that we can sell.

For example, it is possible that some of our revenue may be derived from governmental healthcare programs, including Medicare.

In addition, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “Healthcare Reform Act”), substantially changed the way healthcare is financed by both governmental and private insurers and had a substantial effect on the pharmaceutical industry.

If we are able to charge higher prices to non-government customers than we charge to the U.S.

Government, healthcare reform and controls on healthcare spending in the U.S.

may nonetheless limit the price we charge for our products and the amounts that we can sell.

For example, some of our revenue may be derived from governmental healthcare programs, including Medicare.

Furthermore, beginning in 2011, the Healthcare Reform Act imposed a non-deductible excise tax on pharmaceutical manufacturers or importers who sell “branded prescription drugs,”

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Government programs.

The Healthcare Reform Act and other healthcare reform measures that may be adopted in the future could have an adverse effect on our industry generally and potential future sales and profitability of our current or future products specifically.

The Healthcare Reform Act and other healthcare reform measures that may be adopted in the future could have an adverse effect on our industry generally, as well as potential future sales and profitability of our current or future products.

Laws and regulations governing international operations may hinder us from developing, manufacturing and selling certain product candidates outside of the United States and require us to revise and implement costly compliance programs.

As we expand our operations outside of the United States, we must comply with numerous laws and regulations relating to business operations in each jurisdiction in which we plan to operate.

The creation and implementation of international business practices and compliance programs may be time-consuming and costly, and such programs can be challenging to oversee and to enforce, particularly where reliance on third parties is required.

The Foreign Corrupt Practices Act, or FCPA, prohibits any U.S.

individual or business from paying, offering, or authorizing payment or offering anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business.

The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the Company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. 

As we expand our operations outside of the U.S., compliance with the FCPA, U.K.

Bribery Act and similar anti-corruption provisions in other jurisdictions may be expensive and can be difficult, particularly in countries in which corruption is a recognized problem. Certain payments to hospitals in connection with clinical studies and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

In addition, biodefense companies like SIGA often sell their products directly to foreign governments.

Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S.

nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products.

As we expand our presence outside of the United States, we may require additional resources to ensure compliance with these laws.

In connection with our International Promotion Agreement with Meridian, Meridian serves as the entity that markets and promotes oral TPOXX®

(except in the United States) and is the counterparty to any agreements within covered foreign jurisdictions.

As such, Meridian is responsible for anti-corruption compliance related to its activities.

The failure to comply with laws governing international business practices may result in substantial penalties, including suspension or debarment from government contracting.

Violation of the FCPA can result in significant civil and criminal penalties that can be levied on the Company and its executives.

Violation of the Foreign Corrupt Practices Act ("FCPA") can result in significant civil and criminal penalties that can be levied on the Company and its executives.

Indictment alone under the FCPA can lead to suspension of the right to do business with the U.S.

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Other countries, such as the UK, have anti-bribery laws similar to or more expansive in scope than the FCPA which may be applicable to our operations as we expand outside the U.S.

In connection with our International Promotion Agreement with Meridian, Meridian will serve as the entity that markets and promotes oral TPOXX®

(except in the United States) and will be the counterparty to any agreements with covered foreign jurisdictions.

As such, Meridian will be responsible for anti-corruption compliance related to its activities.

We could incur net losses in the future if options are not exercised under the 19C BARDA Contract.

While our current cash position is strong, our ability to continue to fund future operations will be substantially impacted by cash flows from the 19C BARDA Contract, which may not be sufficient if BARDA elects, in its sole discretion, not to exercise or to significantly delay exercise of some or all of the remaining options under the 19C BARDA Contract.

While we believe our current cash position is strong, our ability to continue to fund future operations will be substantially impacted by cash flows from the 19C BARDA Contract, which may not be sufficient if BARDA elects, in its sole discretion, not to exercise or to significantly delay exercise of some or all of the remaining options under the 19C BARDA Contract.

If cash flows from the 19C BARDA Contract are significantly different from expectations, or if operating expenses or other expenses meaningfully exceed our expectations or cannot be adjusted accordingly, then our business, financial condition, results of operations and prospects could be materially adversely affected.

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under the 19C BARDA Contract, entrusting such vendor or vendors with the care and handling of a substantial portion of IV TPOXX®

If a third-party provider fails to comply with applicable laws and regulations, fails to meet expected deadlines, fails to conduct trials in accordance with regulatory requirements or our stated protocols, experiences shortages or delays, or otherwise does not carry out its contractual duties to us, or encounters physical damage or natural disaster or disruptions at its facilities, for example as a result of the novel coronavirus COVID-19 pandemic, our ability to meet our obligations under the 19C BARDA Contract or to develop, obtain approval and commercialization of IV TPOXX®

If a third-party provider fails to comply with applicable laws and regulations, fails to meet expected deadlines, fails to conduct trials in accordance with regulatory requirements or our stated protocols, experiences shortages or delays, or otherwise does not carry out its contractual duties to us, or encounters physical damage or natural disaster or disruptions at its facilities, for example as a result of the COVID-19 pandemic, our ability to meet our obligations under the 19C BARDA Contract or to develop, obtain approval of and commercialization of IV TPOXX®

or other drug candidates, could be significantly impaired or delayed.

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If third parties do not manufacture our drug candidates or products in sufficient quantities and at an acceptable cost or in compliance with regulatory or contractual requirements and specifications, the fulfillment of contractual requirements under the 19C BARDA Contract, or any other procurement contract, or the development of our drug candidates could be delayed, prevented or impaired.

If our contract manufacturers are unable to generate enough materials to meet commercial obligations or satisfy clinical needs, for example as a result of disruption resulting from the novel coronavirus COVID-19 pandemic, the success of drug products may be jeopardized.

If our contract manufacturers are unable to generate enough materials to meet commercial obligations or satisfy clinical needs, for example as a result of disruption resulting from the COVID-19 pandemic, the success of drug products may be jeopardized.

Our current and anticipated future dependence upon others for the manufacture of our drug candidates may adversely affect our ability to develop drug candidates and perform on commercial contracts on a timely and competitive basis.

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We cannot be certain that our present or future manufacturers will be able to comply with these regulations and other FDA regulatory requirements or similar regulatory requirements outside the U.S.

In addition, due to the novel coronavirus COVID-19 pandemic, regulatory authorities may not conduct required inspections at our CMO facilities, and without such inspections, drug approvals could be delayed.

In addition, due to the COVID-19 pandemic, regulatory authorities may not conduct required inspections at our CMO facilities, and without such inspections, drug approvals could be delayed.

Our government contracts and grants call for compliance with all applicable legal and regulatory requirements, however, we do not control third-party manufacturers and their methods for ensuring adherence to regulatory and legal standards.

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successful completion of clinical trials;

receipt of marketing approvals from FDA for IV and liquid suspension/pediatric formulations of TPOXX®

receipt of marketing approvals, including the impact of marketing restrictions or required post-approval clinical studies, from the FDA for IV and liquid suspension/pediatric formulations of TPOXX®

and similar foreign regulatory authorities;

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any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable;

we may not be successful in recruiting a sufficient number of qualifying subjects for our clinical trials;

the effects of our drug candidates may not be the desired effects or may include undesirable side effects or the drug candidates may have other unexpected characteristics;

the required resources, regulations, or challenges associated with animal studies may increase and make our studies more difficult.

IV and Liquid Suspension/Pediatric TPOXX®

Intravenous and Liquid Suspension/Pediatric TPOXX®

formulations are currently in product development and there can be no assurance of successful development or ultimate commercialization beyond the 19C BARDA Contract.

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patent portfolio has seven patent families consisting of 28 U.S.

utility patents, 86 issued foreign patents, three U.S.

utility patents, 97 issued foreign patents, two U.S.

utility patent applications, and 24 foreign patent applications.

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These agreements may not provide meaningful protection for our trade secrets, confidential information or inventions in the event of unauthorized use or disclosure of such information, and adequate remedies may not exist in the event of such unauthorized use or disclosure.

If our technologies are alleged or found to infringe the patents or proprietary rights of others, we may be sued, we may have to pay damages or be barred from pursuing a technology, or we may have to license those rights and pay royalties to or from others on unfavorable terms.

If our technologies are alleged or found to infringe the patents or proprietary rights of others, we may be sued, we may have to pay damages or be barred from pursuing a technology, or we may have to license those rights from and pay royalties to others on unfavorable terms.

If we are sued, even if we prevail, such litigation may be costly.

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

Our directors, executive officers and principal stockholders beneficially own a significant percentage of our common stock.

Our directors, executive officers and beneficial owners of more than 5% of our common stock ("principal stockholders") beneficially own a significant percentage of our common stock.

As a result, these stockholders, if acting together, have the ability to influence the outcome of corporate actions requiring stockholder approval.

Additionally, this concentration of ownership may have the effect of delaying or preventing a change of control of SIGA.

As of February 24, 2020, directors, executive officers and principal stockholders (excluding index funds) beneficially owned approximately 42% of our outstanding common stock.

As of February 16, 2022, directors, executive officers and principal stockholders (excluding institutional investors) beneficially owned approximately 35% of our outstanding common stock.

In addition to owning common stock of the Company, directors and certain executive officers have the right to acquire additional stock through the exercise or conversion of certain securities.

Our stock repurchase program could affect the price of our common stock and increase volatility and may be suspended or terminated at any time, which may result in a decrease in the trading price of our common stock.

On March 5, 2020 our Board of Directors authorized a share repurchase program for up to $50 million of our common stock through December 31, 2021. This stock repurchase program does not obligate the Company to repurchase any dollar amount or number of shares of our common stock and may be suspended or discontinued at any time, which could cause the market price of our common stock to decline. Repurchases pursuant to our stock repurchase program could affect the price of our common stock and increase its volatility. Important factors that could cause us to limit, suspend or delay the Company’s stock repurchases, without prior notice, and that could in any event impact management’s exercise of its discretion as to the amount and timing of such repurchases include exercise of procurement options under government contracts, alternative opportunities for strategic uses of cash, the stock price of the Company’s common stock, market conditions, and other corporate liquidity requirements and priorities.

The existence of our stock repurchase program could cause the price of our common stock to be higher than it would be in the absence of such a program and could potentially reduce the market liquidity for our common stock. Additionally, repurchases under our stock repurchase program would diminish our cash reserves, which could impact our ability to pursue other opportunities, further develop our technology or adversely affect our operating results. There can be no assurance that any stock repurchases would enhance stockholder value because the market price of our common stock may decline below the levels at which we repurchased such shares. Any failure to repurchase shares could negatively impact our reputation and investor confidence in us and our stock price.

On August 2, 2021, our Board of Directors authorized a new share repurchase program for up to $50 million of our common stock through December 31, 2023. This stock repurchase program does not obligate the Company to repurchase any dollar amount or number of shares of our common stock and may be suspended or discontinued at any time, which could cause the market price of our common stock to decline. Repurchases pursuant to our stock repurchase program could affect the price of our common stock and increase its volatility. Important factors that could cause us to limit, suspend or delay the Company’s stock repurchases, without prior notice, and that could in any event impact management’s exercise of its discretion as to the amount and timing of such repurchases, include the timing of exercise of procurement options under government contracts, alternative opportunities for strategic uses of cash, the stock price of the Company’s common stock, market conditions, and other corporate liquidity requirements and priorities.

A future issuance of preferred stock may adversely affect the rights of the holders of our common stock.

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The issuance of preferred stock could have the effect of making it more difficult for a third party to acquire a majority of our outstanding voting stock, thereby delaying, deferring or preventing a change of control.

General Risk Factors

Global 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.

Occurrence of a global infectious disease outbreak, such as the novel coronavirus (COVID-19) that escalated into a worldwide pandemic, or climate-related disasters, could have a broad impact on global economic conditions, sourcing of raw materials and may continue to impact our ability to promote our products successfully to international governments who may need to divert resources to address the ongoing pandemic and other such matters.

Such delays may reduce our expected revenue from international sales to foreign governments and thereby adversely impact our projected business growth.

The COVID-19 pandemic, for example, has caused significant societal and economic disruption.

The COVID-19 pandemic has caused significant societal and economic disruption.

Such disruption, and the associated risks and costs, are expected to continue for an indeterminate period of time.

Given the uncertain future course of the COVID-19 pandemic, and the uncertain scale and scope of its future impact, the Company is continually reviewing business and financial risks related to the pandemic and seeking coordination with its government partners with respect to the performance of current and future government contracts.

Additionally, the Company is continually coordinating with service providers and vendors, in particular Contract Manufacturing Organizations ("CMOs") that constitute our supply chain, to review actions and risks caused by the COVID-19 pandemic.

As of the filing date of this document, the Company has not identified or been notified by government customers of impediments to the continued full performance of their government contracts.

Given the uncertain future course of the COVID-19 pandemic, and the uncertain scale and scope of its future direct and indirect impact, the Company is continually reviewing business and financial risks related to the pandemic and seeking coordination with its government partners with respect to the performance of current and future government contracts.

Additionally, the Company is continually coordinating with service providers and vendors, in particular Contract Manufacturing Organizations that constitute our supply chain, with respect to actions and risks caused by the COVID-19 pandemic.

Additionally, the Company’s supply chain for the manufacture of TPOXX®

has remained operational on current projects without material COVID-19 related disruption, and in the ordinary course of operations, the supply chain has secured sufficient raw materials to support manufacture and product delivery activities on current projects.

With regard to day-to-day operations, the COVID-19 pandemic has at times slowed the daily pace of execution of government contracts as well as new contract generation, as U.S.

and foreign government staff overseeing health security preparedness has been involved directly or indirectly in governmental responses to the pandemic, which has diverted government staff time that would normally be directed toward contract matters involving SIGA.

The Company expects to experience delays, or slower-than-usual pace, in connection with certain research and development activities, such as those that involve clinical trials.

The Company does not currently expect any pandemic-related delays in research and development activities to have a material adverse impact on the financial condition or annual financial results of the Company, or its long-term performance, but there can be no assurance that such delays will not have such a material adverse impact in the future.

While to date the COVID-19 pandemic has not adversely affected the liquidity position of the Company, and is not currently expected to have a material adverse effect on the financial condition of the Company, there can be no assurance that it will not have such adverse effects, which may be material, in the future. 

Given that the pandemic has diverted foreign government staff time normally directed toward contract matters involving SIGA, the COVID-19 pandemic could affect the timing of international contract awards for oral TPOXX, which could potentially have a material adverse effect on the short-term financial results of the Company.

The pandemic has resulted in almost all of our employees working from home;

however, the shift in location for employees has not had a material adverse impact on the day-to-day operations of the Company.

If the general negative effect of the COVID-19 pandemic becomes more acute or is prolonged, there could be potentially be a material adverse impact on our business and cash flows.

and for the raw materials and supplies necessary to support manufacture and product delivery activities on future projects, could be materially disrupted by COVID-19. With regard to day-to-day operations, the COVID-19 pandemic, and the secondary effects of the pandemic, have at times slowed the daily pace of execution of government contracts as well as new contract generation.

For example, U.S.

and foreign government staffs overseeing health security preparedness have been involved directly or indirectly in governmental responses to the pandemic, which has diverted government staff time that would normally be directed toward contract matters involving SIGA.

The Company expects to experience delays, or a slower than usual pace, in connection with certain research and development activities, such as those that involve clinical trials. While the Company does not currently expect any pandemic-related delays in research and development activities to have a material adverse impact on the financial condition or annual financial results of the Company, or its long-term performance, the Company cannot give assurances as to the full extent of the impact at this time.

Overall, while the COVID-19 pandemic has not adversely affected the liquidity position of the Company, the pandemic has diverted foreign government staff time normally directed toward contract matters involving SIGA and has affected and could continue to affect the timing of international contract awards for oral TPOXX®.

Additionally, although SIGA has completed delivery of TPOXX®

courses covered by the option exercised by the U.S.

Government in 2021, the pandemic could result in a slower pace of future product deliveries if the pandemic results in shortages or delays in the receipt by the supply chain of raw materials or supplies.

Furthermore, Executive Order 14042 by the President of the United States, which subjects federal prime contractors and subcontractors to certain vaccination requirements and other COVID-19 related safety measures, could have a material impact on the availability and/or timing of services provided to SIGA by certain vendors for supply chain activities and research and development activities.

The mandate has been challenged in several cases that are currently pending, and in at least one case a nationwide injunction has barred enforcement of the mandate while the cases are being pursued.

The future outcome of such litigation is uncertain, and consequently the scope and enforceability of the underlying vaccine mandate as it applies to federal contractors and subcontracts, is not known at this time.

If the general negative effect of the COVID-19 pandemic becomes more acute, including due to resurgences in infections or lack of vaccination, there could be material adverse effects to our business and cash flows.

Our business has been and will continue to be affected by the COVID-19 pandemic.

The full extent and nature to which the COVID-19 pandemic, and any related consequences, will impact our business, financial condition and results of operations is uncertain and cannot be predicted.

On September 9, 2021, President Biden directed the U.S.

Department of Labor’s Occupational Safety and Health Administration (“OSHA”) to issue an Emergency Temporary Standard (“ETS”) requiring that all employers with at least 100 employees ensure that their employees are fully vaccinated for COVID-19 or obtain a negative COVID-19 test at least once a week.

President Biden also issued an Executive Order requiring certain COVID-19 precautions for government contractors and their subcontractors, including mandatory employee vaccination (subject to medical and religious exemptions) that directly impacts SIGA given its government contracts. Both mandates were challenged in court.

On January 13, 2022, the U.S.

Supreme Court stayed the vaccine-or-test emergency temporary standard (ETS) that OSHA issued in November 2021.

The stay will be in effect until the claims contesting the ETS’

legality that are pending in the U.S.

Court of Appeals for the Sixth Circuit are fully resolved.

As a result, employers do not need to comply with the ETS and OSHA cannot enforce it.

Although the OSHA ETS is not in effect at this time, employers may be required under other laws to mandate vaccines (subject to accommodation obligations), such as under the federal vaccine mandate for healthcare workers and the New York City Order requiring vaccines.

The vaccine mandate for federal contractors and subcontractors is currently not in effect, as it was stayed by a court in December 2021.

It is not currently possible to predict with any certainty the exact impact on us given the requirements for government contractors and their subcontractors.

SIGA does not expect a material impact on the current workforce from any requirement to mandate COVID-19 vaccination of our workforce, however such requirements could result in employee attrition and difficulty securing future labor needs at our subcontractors, and therefore have an adverse effect on the amount and timing of future profits.

In addition, any requirement to impose obligations on our suppliers under the Executive Order covering government contractors and their subcontractors could impact the price and continuity of services provided in connection with the supply chain, commercial activities and research and development activities, which in turn could impact the Company’s performance under government contracts and the amount and timing of future profits.

Future 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.

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Even if we do consummate an acquisition, in connection therewith we may be required to issue equity (thereby diluting our current stockholders) or debt, we may not be able to integrate successfully the acquired personnel, operations and technologies, or effectively manage the combined business following the acquisition, or the acquired business could otherwise fail to meet our expectations, which, in each case, could have a material adverse effect on our business projections, financial condition, results of operations and prospects.

The health security market in which we compete and will compete is highly competitive.

The health security markets in which we compete and will compete are highly competitive.

The health security industry is characterized by rapid and significant technological change.

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We use through third parties, for example, small amounts of radioactive isotopes commonly used in pharmaceutical research, which are stored, used and disposed of in accordance with Nuclear Regulatory Commission regulations.

Our general liability policy provides coverage up to annual aggregate limits of $2 million and coverage of $2 million per occurrence.

Our general liability policy provides coverage up to annual aggregate limits of $2 million and coverage of $1 million per occurrence.

The loss of key personnel or our ability to recruit or retain qualified personnel could adversely affect our results of operations.

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We must continue to recruit, retain and motivate management and other employees sufficient to maintain our current business and support our projected growth.

The loss of services of any members of our key management team could have a material adverse effect on our business.

The loss of services of any members of our key management team could have a material adverse effect on our business. The ongoing COVID-19 pandemic has increased employment changes in many industries, including ours.

We cannot predict with certainty how, if at all, this may impact SIGA.

Our business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in our cyber-security.

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For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

Also, confidential patient and other information may be compromised in a cyber-attack or cyber-intrusion.

Also, confidential patient and other personal or sensitive information may be compromised in a cyber-attack or cyber-intrusion.

To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, damage to our reputation, and the further development of our drug candidates could be delayed.

We 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.

Although our current cash position is strong, we may require additional financing and, while we have raised funds through credit facilities and the issuance of new equity or the exercise of options or warrants in the past, there is no guarantee that we will continue to be successful in raising such funds should we need to seek to do so.

Although we believe our current cash position is strong, we may require additional financing and, while we have raised funds through credit facilities and the issuance of new equity or the exercise of options or warrants in the past, there is no guarantee that we will continue to be successful in raising such funds should we need to seek to do so.

If we are unable to raise additional funds, we could be forced to discontinue, cease or limit certain strategic transactions or operations and equity investors could experience significant or total losses of their investments.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors