SIGA Technologies (SIGA) risk factors, FY2024 10-K

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 negatively impact our business and liquidity
6. 06Our business could be adversely affected by a negative audit by the U.S. Government

Risks Related to Regulatory Approvals

1. 07Failure 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
2. 08Failure to obtain future regulatory approval in additional international jurisdictions could prevent us from marketing our products in certain jurisdictions abroad

Risks Related to Commercial and International Activities

1. 09Changing 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. 10Our 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 expose us to risks associated with conducting business in international markets
3. 11If 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
4. 12increased management and infrastructure costs
5. 13We 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.
6. 14For 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
7. 15Although 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
8. 16Any 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
9. 17The 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
10. 18We 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

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

1. 19If 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. 20Problems 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. 21acceptance 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. 22We may not be able to fully commercialize the liquid suspension/pediatric formulation of TPOXX®, or other additional indications for TPOXX®, if our clinical trials do not demonstrate adequate safety or our animal studies do not demonstrate adequate efficacy
3. 23Liquid Suspension/Pediatric TPOXX® formulations are currently in product development and there can be no assurance of successful development or ultimate commercialization
4. 24achieve customer acceptance

Risks Related to Our Intellectual Property

1. 25Our ability to compete may decrease if we do not adequately protect our intellectual property rights
2. 26If 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. 27Concentration of ownership of our capital stock could delay or prevent a change of control
2. 28A future issuance of preferred stock may adversely affect the rights of the holders of our common stock
3. 29Global 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. 30Future 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. 31The health security markets in which we compete and will compete are highly competitive
6. 32Product 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. 33Our activities may involve hazardous materials, use of which may subject us to environmental regulatory liabilities
8. 34The loss of key personnel or our ability to recruit or retain qualified personnel could adversely affect our results of operations
9. 35Our business and operations would suffer in the event of a significant computer system failure, cyber-attack or deficiency in our cyber-security
10. 36We 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