SIGA TECHNOLOGIES INC

Previous wording

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 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.

Current wording

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 the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA"). The EMA and MHRA have approved oral TPOXX® for the treatment of smallpox, cowpox, and vaccinia complications following vaccination against smallpox. PDMA has approved oral TPOXX® for the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against smallpox, and Health Canada has approved oral TPOXX® for the treatment of smallpox.

Previous wording

On July 24, 2025, the EMA’s Committee for Medicinal Products for Human Use ("CHMP") closed its third annual reassessment for Tecovirimat-SIGA and initiated a referral procedure for the product following questions over its effectiveness in the treatment of mpox. These questions were raised following receipt of results from certain non-SIGA sponsored clinical trials evaluating tecovirimat as a potential mpox treatment including the PALM007 and STOMP clinical trials. In the referral procedure, CHMP reviewed all available data on the safety and efficacy of Tecovirimat-SIGA for all its authorized indications in order to make a recommendation to the European Commission whether the marketing authorization should be maintained, modified, suspended or withdrawn. On March 27, 2026, the CHMP issued its opinion following the conclusion of its review. CHMP confirmed the positive benefit-risk balance of Tecovirimat-SIGA as a treatment for smallpox, cowpox and vaccinia complications, and recommended, based on the results of the mpox clinical trials, that the product no longer be used for the treatment of mpox. In April 2026, the MHRA requested SIGA align the Tecovirimat-SIGA label in the U.K. with the outcome of the referral procedure.

Current wording

On July 24, 2025, the EMA’s Committee for Medicinal Products for Human Use ("CHMP") closed its third annual reassessment for Tecovirimat-SIGA and initiated a referral procedure for the product following questions over its effectiveness in the treatment of mpox. These questions were raised following receipt of results from certain non-SIGA sponsored clinical trials evaluating tecovirimat as a potential mpox treatment including the PALM007 and STOMP clinical trials. In the referral procedure, CHMP reviewed all available data on the safety and efficacy of Tecovirimat-SIGA for all its authorized indications in order to make a recommendation to the European Commission whether the marketing authorization should be maintained, modified, suspended or withdrawn. On March 27, 2026, the CHMP issued its opinion following the conclusion of its review. CHMP confirmed the positive benefit-risk balance of Tecovirimat-SIGA as a treatment for smallpox, cowpox and vaccinia complications, and recommended, based on the results of the mpox clinical trials, that the product no longer be used for the treatment of mpox, and on May 29, 2026, the European Commission adopted the opinion of the CHMP. In April 2026, the MHRA requested SIGA align the Tecovirimat-SIGA label in the U.K. with the outcome of the referral procedure.

Previous wording

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 within the next twelve months.

Current wording

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 first half of 2027.

Previous wording

The base period of performance specifies potential payments of approximately $79.2 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 $59.5 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities. As of March 31, 2026, 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 $34.0 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.

Current wording

The base period of performance specifies potential payments of approximately $79.2 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 $59.5 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities. As of June 30, 2026, 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 $37.4 million for other base period activities. IV BDS has been used for the manufacture of courses of IV FDP.

Previous wording

The options that have been exercised as of March 31, 2026, provide for payments up to approximately $545.2 million. As of March 31, 2026, 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, 2026, a cumulative total of $450.2 million of oral TPOXX® has been delivered to the Strategic Stockpile and accepted; a cumulative total of $61.4 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 $11.9 million in connection with post-marketing activities for oral and IV TPOXX®.

Current wording

The options that have been exercised as of June 30, 2026, provide for payments up to approximately $545.2 million. As of June 30, 2026, 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 June 30, 2026, a cumulative total of $450.2 million of oral TPOXX® has been delivered to the Strategic Stockpile and accepted; a cumulative total of $76.8 million of IV FDP has been delivered to the Strategic Stockpile and accepted (IV BDS that had been set aside and recorded as deferred revenue was recognized as revenue when the IV FDP, containing IV BDS, was delivered); and the Company has been cumulatively reimbursed $13.0 million in connection with post-marketing activities for oral and IV TPOXX®.

Previous wording

In the three months ended March 31, 2026, the Company did not have international sales. In the three months ended March 31, 2025, the Company recognized $5.8 million of international sales consisting of a delivery of oral TPOXX® to one country.

Current wording

In the three and six months ended June 30, 2026, the Company recognized $13.0 million of international sales. In the six months ended June 30, 2025, the Company recognized $5.8 million of international sales consisting of a delivery of oral TPOXX® to one country. There was no revenue recognized in connection with international contracts during the three months ended June 30, 2025.

Previous wording

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.

Current wording

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 had primary responsibility for the advertising, promotion and sale of oral TPOXX® in all geographic regions. Meridian had 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 performed non-promotional activities under specified contracts with third parties entered into prior to June 1, 2024, that provided for the sale of oral TPOXX® in the Current Territory. The International Promotion Agreement entitled 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 had a fixed term that expired on May 31, 2026.

Previous wording

The U.S. tariffs implemented in 2025 and continuing in 2026, 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.

Current wording

The U.S. tariffs implemented in 2025 and continuing in 2026, and subsequently implemented retaliatory tariffs, did not materially impact our second quarter or six months ended June 30, 2026 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.

Previous wording

For the three months ended March 31, 2026, revenues from product sales and supportive services were $3.5 million. Such revenues include $1.2 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA Contract as well as $2.3 million of reimbursed supportive services in connection with a manufacturing technology transfer. 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.

Current wording

For the three months ended June 30, 2026, revenues from product sales and supportive services were $37.9 million. Such revenues include $24.4 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA Contract, $13.0 million of sales to two international countries, as well as $0.5 million of reimbursed supportive services in connection with a manufacturing technology transfer. For the three months ended June 30, 2025, revenues from product sales and supportive services were $79.1 million. Such revenues include $53.3 million of oral TPOXX® and $25.8 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA contract.

Previous wording

Revenues from research and development activities for the three months ended March 31, 2026 and 2025, were $2.7 million and $1.2 million, respectively. The revenues for the three months ended March 31, 2026, were earned in connection with performance of research and development activities under the 19C BARDA Contract. 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 increase of $1.5 million of revenue is primarily related to an increase in billable activities under the 19C BARDA Contract.

Current wording

Revenues from research and development activities for the three months ended June 30, 2026 and 2025, were $3.1 million and $2.0 million, respectively. The revenues for the three months ended June 30, 2026, were earned in connection with performance of research and development activities under the 19C BARDA Contract. The revenues for the three months ended June 30, 2025, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The increase of $1.1 million of revenue is primarily related to an increase in billable activities under the 19C BARDA Contract.

Previous wording

Selling, general and administrative (“SG&A”) expenses for the three months ended March 31, 2026 and 2025 were $4.7 million and $5.7 million, respectively. The decrease of $1.0 million primarily reflects lower professional service fees and lower international business development expenses, partially offset by higher compensation costs.

Current wording

Selling, general and administrative (“SG&A”) expenses for the three months ended June 30, 2026 and 2025 were $5.1 million and $5.5 million, respectively. The decrease of $0.4 million primarily reflects lower corporate expenses across a range of functions and activities, including consulting activities, professional services, and international business development activities, partially offset by higher compensation costs.

Previous wording

Other income, net for the three months ended March 31, 2026 and 2025 were $1.3 million and $1.7 million, respectively. These amounts reflect interest income earned on cash and cash equivalents.

Current wording

Other income, net for the three months ended June 30, 2026 and 2025 were $0.9 million and $1.6 million, respectively. These amounts reflect interest income earned on cash and cash equivalents.

Previous wording

For the three months ended March 31, 2026 and 2025, we recorded a pre-tax loss of ($4.0) million and a pre-tax loss of ($0.6) million, respectively, and a corresponding income tax benefit of $0.6 million and $0.2 million, respectively. The effective tax rates during the three months ended March 31, 2026 and 2025 were 14.6% and 28.4%, respectively. Our effective tax rates for the periods ended March 31, 2026 and 2025 differ from the statutory rate primarily as a result of state taxes and non-deductible executive compensation under Internal Revenue Code Section 162(m).

Current wording

For the three months ended June 30, 2026 and 2025, we recorded a pre-tax income of $14.9 million and $47.3 million, respectively, and a corresponding income tax provision of $2.4 million and $11.8 million, respectively. The effective tax rates during the three months ended June 30, 2026 and 2025 were 16.1% and 24.9%, respectively. Our effective tax rates for the periods ended June 30, 2026 and 2025 differ from the statutory rate primarily as a result of currently forecasted losses for the full year, state taxes and non-deductible executive compensation under Internal Revenue Code Section 162(m). With respect to currently forecasted losses for the full year, such forecast is based on orders received to date and is subject to update upon the receipt of new procurement orders.

Previous wording

Cost of sales and supportive services for the three months ended March 31, 2026 and 2025 were $2.9 million and $0.2 million, respectively. Such costs in 2026 were primarily associated with the costs of supportive services in connection with a manufacturing technology transfer, as well as costs for the manufacture and delivery of courses of IV TPOXX® to the U.S. Government under the 19C BARDA Contract. 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.

Current wording

Cost of sales and supportive services for the six months ended June 30, 2026 and 2025 were $20.5 million and $25.7 million, respectively. Such costs in 2026 were primarily associated with the costs for the manufacture and delivery of courses of IV TPOXX® to the U.S. Government under the 19C BARDA Contract, costs for the manufacture and delivery of oral TPOXX® to international countries as well as the costs of supportive services in connection with a manufacturing technology transfer. Such costs in 2025 were associated with the manufacture and delivery of courses of oral and IV TPOXX® to the U.S. Government under the 19C BARDA contract.

Previous wording

Research and development (“R&D”) expenses for the three months ended March 31, 2026 and 2025 were $3.9 million and $3.5 million, respectively, reflecting an increase of approximately $0.4 million. The expense increase is primarily attributable to costs incurred in connection with the EMA referral procedure that was focused on mpox.

Current wording

Research and development (“R&D”) expenses for the six months ended June 30, 2026 and 2025 were $8.3 million and $7.9 million, respectively, reflecting an increase of approximately $0.4 million. The expense increase is primarily attributable to an increase in direct vendor related costs under the 19C BARDA Contract and costs incurred in connection with the EMA referral procedure that was focused on mpox, partially offset by lower self-funded research and development activities, compensation costs and regulatory activities.

Previous wording

As of March 31, 2026, we had $145.6 million in cash and cash equivalents, compared with $155.0 million at December 31, 2025. 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.

Current wording

As of June 30, 2026, we had $117.6 million in cash and cash equivalents, compared with $155.0 million at December 31, 2025. 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.

Previous wording

Net cash (used in)/provided by operating activities for the three months ended March 31, 2026 and 2025 was ($8.7) million and $7.1 million, respectively. For the three months ended March 31, 2026, the net cash used in operating activities primarily relates to the use of cash (net of research development revenues) for customary operating activities and inventory. 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.

Current wording

Net cash provided by operating activities for the six months ended June 30, 2026 and 2025 was $6.5 million and $70.1 million, respectively. For the six months ended June 30, 2026, the net cash provided by operating activities primarily relates to the receipt of approximately $11 million from sales of IV TPOXX® from the U.S. Government, $13 million from the sales of oral TPOXX® to international countries, and $2 million from investment income, partially offset by the use of cash (net of research development revenues) for customary operating activities and inventory. For the six months ended June 30, 2025, the receipt of approximately $80 million from sales of TPOXX® to the U.S. Government and an international customer, $20 million from sales of TPOXX® 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.

Previous wording

For the three months ended March 31, 2026, there were no cash-related investing activities; acquisitions of equipment this quarter were not billed as of March 31, 2026. For the three months ended March 31, 2025, there was minimal (less than $25,000) cash-related investing activities.

Current wording

For the six months ended June 30, 2026, there were no cash-related investing activities; acquisitions of equipment during the six months ended June 30, 2026 were not billed as of June 30, 2026. For the six months ended June 30, 2025, there was minimal (less than $25,000) cash-related investing activities.

Previous wording

Cash used in financing activities for the three months ended March 31, 2026 was $0.7 million, which was attributable to the payments of tax obligations in connection with stock issued to employees as well as payments of accrued dividends on vested equity awards. Cash used in financing activities for the three months ended March 31, 2025 was $0.2 million, which was attributable to the payment of tax obligations in connection with stock issued to employees.

Current wording

Cash used in financing activities for the six months ended June 30, 2026 was $43.9 million, which was mostly attributable to the payment of a special cash dividend of approximately $43.3 million as well as the payments of tax obligations in connection with stock issued to employees. Cash used in financing activities for the six months ended June 30, 2025 was $43.1 million, which was mostly attributable to the payment of a special cash dividend of approximately $42.9 million.

Previous wording

As of March 31, 2026, we had outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $3.5 million.

Current wording

As of June 30, 2026, we had outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $1.3 million.

Previous wording

Forward-looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations and statements relating to the progress of SIGA’s development programs and timelines for bringing products to market, delivering products to domestic and international customers, and the enforceability of our procurement contracts, such as the 19C BARDA Contract (the "BARDA Contract"), with the U.S. Biomedical Advanced Research and Development Authority ("BARDA"). 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 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 or maintain 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 fr…

Excerpt shortened here; the source contains the full paragraph.

Current wording

Forward-looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations and statements relating to the progress of SIGA’s development programs and timelines for bringing products to market, delivering products to domestic and international customers, and the enforceability of our procurement contracts. 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 is not able to secure in a timely manner new contracts with the U.S. Government to substantially maintain or expand the U.S. Government stockpile of TPOXX®, (ii) the risk that SIGA may not complete performance under the 19C BARDA Contract (the "BARDA Contract"), with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") on schedule or in accordance with contractual terms, (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 or maintain 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 …

Excerpt shortened here; the source contains the full paragraph.