What changed in SIGA TECHNOLOGIES INC's 10-K — 2024 vs 2025
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Paragraph-level year-over-year comparison of SIGA TECHNOLOGIES INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.
+230 added−216 removedSource: 10-K (2026-03-10) vs 10-K (2025-03-11)
Top changes in SIGA TECHNOLOGIES INC's 2025 10-K
230 paragraphs added · 216 removed · 161 edited across 6 sections
- Item 1A. Risk Factors+83 / −84 · 56 edited
- Item 7. Management's Discussion & Analysis+66 / −61 · 45 edited
- Item 1. Business+70 / −61 · 50 edited
- Item 1C. Cybersecurity+5 / −4 · 4 edited
- Item 5. Market for Registrant's Common Equity+5 / −5 · 5 edited
Item 1. Business
Business — how the company describes what it does
50 edited+20 added−11 removed91 unchanged
Item 1. Business
Business — how the company describes what it does
50 edited+20 added−11 removed91 unchanged
2024 filing
2025 filing
Biggest changeAs of December 31, 2024, a cumulative total of $396.9 million of oral TPOXX® has been delivered to the Strategic Stockpile and accepted, of which approximately $15 million was delivered in the first quarter of 2024, approximately $8 million was delivered in the third quarter of 2024, and approximately $51 million was delivered in the fourth quarter of 2024; a cumulative total of $25.4 million of IV FDP has been delivered to the Strategic Stockpile and accepted, of which approximately $17 million of revenue (including recognition of deferred revenue) was recorded in the second quarter of 2024 and approximately $8 million of revenue (including recognition of deferred revenue) was recorded in the fourth quarter of 2024; $10.3 million has been received for the manufacture of IV BDS (such amount is recorded as deferred revenue); and the Company has been cumulatively reimbursed $9.4 million in connection with post-marketing activities for oral and IV TPOXX®.
Biggest changeAs of December 31, 2025, 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 $10.9 million in connection with post-marketing activities for oral and IV TPOXX®.
Patent Number Country Protection Conferred Issue Date Expiration Date US 7737168 United States Method of treating orthopoxvirus infection with ST-246 June 15, 2010 September 4, 2031 US 8039504 United States Pharmaceutical compositions and unit dosage forms containing ST-246 October 18, 2011 July 23, 2027 US 9233097 United States Liquid Pharmaceutical formulations containing ST-246 January 12, 2016 August 2, 2031 US 9339466 United States Certain polymorph of ST-246, method of preparation of the polymorph and pharmaceutical compositions containing the polymorph May 17, 2016 March 23, 2031 US 9546137 United States Methods of preparing ST-246 January 17, 2017 August 14, 2033 US 9744154 United States Polymorphic forms of ST-246 and methods of preparation August 29, 2017 March 23, 2031 8 Table of Contents US 9862683 United States Methods of preparing Tecovirimat January 9, 2018 August 14, 2033 US 9670158 United States Amorphous Tecovirimat preparation June 6, 2017 July 11, 2034 US 9889119 United States Amorphous Tecovirimat preparation February 13, 2018 July 11, 2034 US 9907859 United States ST-246 liquid formulations and methods March 6, 2018 August 2, 2031 US 10029985 United States Methods of preparing Tecovirimat July 24, 2018 August 14, 2033 US 10045963 United States Amorphous Tecovirimat preparation August 14, 2018 July 11, 2034 US 10045964 United States Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs August 14, 2018 March 23, 2031 US 10124071 United States ST-246 liquid formulations and methods November 13, 2018 August 2, 2031 US 10155723 United States Methods of preparing Tecovirimat December 18, 2018 August 14, 2033 US 10406137 United States Certain polymorphs of ST-246 and pharmaceutical compositions containing the polymorphs September 10, 2019 March 23, 2031 US 10406103 United States Rehydration of micronized Tecovirimat monohydrate September 10, 2019 November 14, 2034 US 10576165 United States Liquid Pharmaceutical formulations containing ST-246 March 3, 2020 August 2, 2031 US 10864282 United States Methods of preparing liquid formulations containing ST-246 December 15, 2020 August 2, 2031 US 10662155 United States Methods of preparing Tecovirimat May 26, 2020 August 14, 2033 US 10716759 United States Rehydration of micronized Tecovirimat monohydrate July 21, 2020 November 14, 2034 US 10933050 United States Certain polymorphs of ST-246 and pharmaceutical compositions containing the polymorphs March 2, 2021 March 23, 2031 US 11433051 United States ST-246 suspension formulations September 6, 2022 November 27, 2039 US 11779566 United States ST-246 suspension formulations October 10, 2023 February 15, 2037 US 11890270 United States Methods of treating orthopoxvirus using a certain polymorph February 6, 2024 March 23, 2031 SG 184201 Singapore Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs June 22, 2015 March 23, 2031 SG 10201506031U Singapore ST-246 liquid formulations and methods June 11, 2021 August 2, 2031 RU 2578606 Russian Federation Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus March 27, 2016 March 23, 2031 OA 16109 OAPI ^ /Africa Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus October 31, 2013 March 23, 2031 NZ 602578 New Zealand Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus December 2, 2014 March 23, 2031 MX 326231 Mexico Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 December 11, 2014 April 23, 2027 MX 348481 Mexico Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases June 15, 2017 April 23, 2027 MX 347795 Mexico ST-246 liquid formulations and methods May 15, 2017 August 2, 2031 MX 361428 Mexico Polymorphic forms of ST-246 and methods of preparation December 6, 2018 March 23, 2031 MX 363189 Mexico Use of pharmaceutical compositions containing ST-246 March 14, 2019 April 23, 2027 MX 368106 Mexico ST-246 liquid formulations and methods September 19, 2019 August 2, 2031 KR 101868117 Korea ST-246 liquid formulations and methods June 8, 2018 August 2, 2031 JP 5898196 Japan Liquid Pharmaceutical formulations containing ST-246 March 11, 2016 August 2, 2031 JP 6018041 Japan Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs October 7, 2016 March 23, 2031 JP 6188802 Japan Methods of preparing Tecovirimat August 10, 2017 August 14, 2033 JP 6444460 Japan Methods of preparing Tecovirimat December 7, 2018 August 14, 2033 JP 6564514 Japan Methods of preparing Tecovirimat August 2, 2019 August 14, 2033 9 Table of Contents JP 6594303 Japan Rehydration of micronized Tecovirimat monohydrate October 4, 2019 November 14, 2034 JP 6843616 Japan Amorphous Tecovirimat preparation February 29, 2021 July 11, 2034 JP 7074677 Japan ST-246 suspension formulations May 24, 2022 February 15, 2037 JP 7297858 Japan ST-246 suspension formulations June 16, 2023 February 15, 2037 BR 112012023743-8 Brazil Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs February 18, 2020 March 23, 2031 BR 112013002646-4 Brazil Liquid Pharmaceutical formulations containing ST-246 January 4, 2022 August 2, 2031 CN 2011800245893 China Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs August 26, 2015 March 23, 2031 CN 2013800429237 China Methods of preparing Tecovirimat June 20, 2017 August 14, 2033 CN 2017103075357 China Methods of preparing Tecovirimat March 6, 2020 August 14, 2033 CN 2014800653387 China Rehydration of micronized Tecovirimat monohydrate February 7, 2020 November 14, 2034 CN 202010101449 China Methods of preparing Tecovirimat June 20, 2023 August 14, 2033 CA 2685153 Canada Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 December 16, 2014 April 23, 2027 CA 2866037 Canada Chemicals, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases May 16, 2017 April 23, 2027 CA 2807528 Canada Liquid Pharmaceutical formulations containing ST-246 September 25, 2018 August 2, 2031 CA 2966466 Canada Use of ST-246 to treat orthopoxvirus infections August 25, 2020 April 23, 2027 CA 2882506 Canada Methods of preparing Tecovirimat October 20, 2020 August 14, 2033 CA 2793533 Canada Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs February 26, 2019 March 23, 2031 CA 2917199 Canada Amorphous Tecovirimat preparation August 31, 2021 July 11, 2034 CA 2930461 Canada Rehydration of micronized Tecovirimat monohydrate August 16, 2022 November 14, 2034 CA 3090294 Canada Methods of preparing Tecovirimat January 24, 2023 August 14, 2033 CA 3128535 Canada Amorphous Tecovirimat preparation October 15, 2024 July 11, 2034 AU 2011232551 Australia Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus February 26, 2015 March 23, 2031 AU 2011285871 Australia Liquid Pharmaceutical formulations containing ST-246 August 6, 2015 August 2, 2031 AU 2013302764 Australia Methods of preparing Tecovirimat April 5, 2018 August 14, 2033 AU 2014290333 Australia Amorphous Tecovirimat preparation February 21, 2019 July 11, 2034 AU 2014353235 Australia Rehydration of micronized Tecovirimat monohydrate August 22, 2019 November 14, 2034 AU 2018201499 Australia Methods of preparing Tecovirimat May 21, 2020 August 14, 2033 AU 2019208252 Australia Rehydration of micronized Tecovirimat monohydrate July 2, 2020 November 14, 2034 AU 20172211295 Australia ST-246 suspension formulations May 2, 2022 February 15, 2037 AU 2020202894 Australia Methods of preparing Tecovirimat July 7, 2022 August 14, 2033 AU 2022202841 Australia Methods of preparing Tecovirimat February 1, 2024 August 14, 2033 AU 2022218556 Australia ST-246 suspension formulations November 28, 2024 February 15, 2037 AP 3221 ARIPO*/Africa Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus April 3, 2015 March 23, 2031 ZA 2012/07141 South Africa Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs June 29, 2016 March 23, 2031 ZA 2013/00930 South Africa Liquid Pharmaceutical formulations containing ST-246 November 25, 2015 August 2, 2031 IL 201736 Israel Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 October 1, 2016 April 23, 2027 IL 236944 Israel Methods of preparing Tecovirimat February 1, 2017 August 14, 2033 IL 242665 Israel Methods of preparing intermediate in the preparation of Tecovirimat February 1, 2020 April 23, 2027 IL 224430 Israel Liquid Pharmaceutical formulations containing ST-246 December 27, 2019 August 2, 2031 IL 242666 Israel Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases December 1, 2018 April 23, 2027 IL 221991 Israel Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs October 1, 2019 March 23, 2031 IL 269370 Israel Compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases December 1, 2020 April 23, 2027 IL 242331 Israel Amorphous Tecovirimat preparation March 1, 2021 July 11, 2034 IL 244731 Israel Rehydration of micronized Tecovirimat monohydrate September 1, 2021 November 14, 2034 IL 282098 Israel Rehydration of micronized Tecovirimat monohydrate April 3, 2023 November 14, 2034 10 Table of Contents IL 260229 Israel ST-246 suspension formulations May 2, 2023 February 15, 2037 BE 1638938 Belgium Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2029 BE 2549871 Belgium Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 BE 2600715 Belgium Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 CH 2549871 Switzerland Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 CH 2600715 Switzerland Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 DE 2549871 Germany Polymorphic forms of ST-246 August 22, 2018 March 23, 2036 DE 2887938 Germany Methods of preparing Tecovirimat January 10, 2018 August 14, 2033 DE 2600715 Germany Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 DE 3321253 Germany Methods of preparing Tecovirimat February 12, 2020 August 14, 2033 DE 3021836 Germany Amorphous Tecovirimat preparation August 27, 2020 July 11, 2034 DE 3043793 Germany Rehydration of micronized Tecovirimat monohydrate January 6, 2021 November 14, 2034 DE 3763702 Germany Amorphous Tecovirimat preparation December 13, 2023 July 11, 2034 DK 2549871 Denmark Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 DK 2600715 Denmark Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 ES 1638938 Spain Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2029 FR 2887938 France Methods of preparing Tecovirimat January 10, 2018 August 14, 2033 FR 2549871 France Polymorphic forms of ST-246 August 22, 2018 March 22, 2036 FR 2600715 France Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 FR 3321253 France Methods of preparing Tecovirimat February 12, 2020 August 14, 2033 FR 3021836 France Amorphous Tecovirimat preparation August 27, 2020 July 11, 2034 FR 3043793 France Rehydration of micronized Tecovirimat monohydrate January 6, 2021 November 14, 2034 FR 3763702 France Amorphous Tecovirimat preparation December 13, 2023 July 11, 2034 GB 2887938 United Kingdom Methods of preparing Tecovirimat January 10, 2018 August 14, 2033 GB 2549871 United Kingdom Polymorphic forms of ST-246 August 22, 2018 March 22, 2036 GB 2600715 United Kingdom Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 11 Table of Contents GB 3321253 United Kingdom Methods of preparing Tecovirimat February 12, 2020 August 14, 2033 GB 3021836 United Kingdom Amorphous Tecovirimat preparation August 27, 2020 July 11, 2034 GB 3043793 United Kingdom Rehydration of micronized Tecovirimat monohydrate January 6, 2021 November 14, 2034 GB 3763702 United Kingdom Amorphous Tecovirimat preparation December 13, 2023 July 11, 2034 HK 1179824 Hong Kong Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs June 21, 2019 March 23, 2031 HK 1184639 Hong Kong Liquid Pharmaceutical formulations containing ST-246 November 12, 2021 October 28, 2033 IT 502017000078377 Italy Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2029 NL 1638938 Netherlands Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 17, 2029 SE 1638938 Sweden Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2029 *African Regional Intellectual Property Organization ("ARIPO") designated contracting states are as follows: Botswana, Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Sierra Leone, Sudan, Swaziland, Tanzania, Uganda, Zambia, and Zimbabwe. ^Organisation Africaine de la Propriété Intellectuelle ("OAPI") designated contracting states are as follows: Benin, Burkina Faso, Cameroon, the Central African Republic, Chad, DRC, Côte d’Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea-Bissau, Mali, Mauritania, the Niger, Senegal, and Togo.
Patent Number Country Protection Conferred Issue Date Expiration Date US 7737168 United States Method of treating orthopoxvirus infection with ST-246 June 15, 2010 September 4, 2031 US 8039504 United States Pharmaceutical compositions and unit dosage forms containing ST-246 October 18, 2011 July 23, 2027 US 9233097 United States Liquid Pharmaceutical formulations containing ST-246 January 12, 2016 August 2, 2031 US 9339466 United States Certain polymorph of ST-246, method of preparation of the polymorph and pharmaceutical compositions containing the polymorph May 17, 2016 March 23, 2031 US 9546137 United States Methods of preparing ST-246 January 17, 2017 August 14, 2033 US 9744154 United States Polymorphic forms of ST-246 and methods of preparation August 29, 2017 March 23, 2031 9 Table of Contents US 9862683 United States Methods of preparing Tecovirimat January 9, 2018 August 14, 2033 US 9670158 United States Amorphous Tecovirimat preparation June 6, 2017 July 11, 2034 US 9889119 United States Amorphous Tecovirimat preparation February 13, 2018 July 11, 2034 US 9907859 United States ST-246 liquid formulations and methods March 6, 2018 August 2, 2031 US 10029985 United States Methods of preparing Tecovirimat July 24, 2018 August 14, 2033 US 10045963 United States Amorphous Tecovirimat preparation August 14, 2018 July 11, 2034 US 10045964 United States Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs August 14, 2018 March 23, 2031 US 10124071 United States ST-246 liquid formulations and methods November 13, 2018 August 2, 2031 US 10155723 United States Methods of preparing Tecovirimat December 18, 2018 August 14, 2033 US 10406137 United States Certain polymorphs of ST-246 and pharmaceutical compositions containing the polymorphs September 10, 2019 March 23, 2031 US 10406103 United States Rehydration of micronized Tecovirimat monohydrate September 10, 2019 November 14, 2034 US 10576165 United States Liquid Pharmaceutical formulations containing ST-246 March 3, 2020 August 2, 2031 US 10864282 United States Methods of preparing liquid formulations containing ST-246 December 15, 2020 August 2, 2031 US 10662155 United States Methods of preparing Tecovirimat May 26, 2020 August 14, 2033 US 10716759 United States Rehydration of micronized Tecovirimat monohydrate July 21, 2020 November 14, 2034 US 10933050 United States Certain polymorphs of ST-246 and pharmaceutical compositions containing the polymorphs March 2, 2021 March 23, 2031 US 11433051 United States ST-246 suspension formulations September 6, 2022 November 27, 2039 US 11779566 United States ST-246 suspension formulations October 10, 2023 February 15, 2037 US 11890270 United States Methods of treating orthopoxvirus using a certain polymorph February 6, 2024 March 23, 2031 US 12433868 United States Unit dosages containing a certain polymorph October 7, 2025 March 23, 2031 SG 184201 Singapore Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs June 22, 2015 March 23, 2031 SG 10201506031U Singapore ST-246 liquid formulations and methods June 11, 2021 August 2, 2031 RU 2578606 Russian Federation Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus March 27, 2016 March 23, 2031 OA 16109 OAPI ^ /Africa Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus October 31, 2013 March 23, 2031 NZ 602578 New Zealand Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus December 2, 2014 March 23, 2031 MX 326231 Mexico Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 December 11, 2014 April 23, 2027 MX 348481 Mexico Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases June 15, 2017 April 23, 2027 MX 347795 Mexico ST-246 liquid formulations and methods May 15, 2017 August 2, 2031 MX 361428 Mexico Polymorphic forms of ST-246 and methods of preparation December 6, 2018 March 23, 2031 MX 363189 Mexico Use of pharmaceutical compositions containing ST-246 March 14, 2019 April 23, 2027 MX 368106 Mexico ST-246 liquid formulations and methods September 19, 2019 August 2, 2031 KR 101868117 Korea ST-246 liquid formulations and methods June 8, 2018 August 2, 2031 JP 5898196 Japan Liquid Pharmaceutical formulations containing ST-246 March 11, 2016 August 2, 2031 JP 6018041 Japan Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs October 7, 2016 March 23, 2031 JP 6188802 Japan Methods of preparing Tecovirimat August 10, 2017 August 14, 2033 JP 6444460 Japan Methods of preparing Tecovirimat December 7, 2018 August 14, 2033 JP 6564514 Japan Methods of preparing Tecovirimat August 2, 2019 August 14, 2033 10 Table of Contents JP 6594303 Japan Rehydration of micronized Tecovirimat monohydrate October 4, 2019 November 14, 2034 JP 6843616 Japan Amorphous Tecovirimat preparation February 29, 2021 July 11, 2034 JP 7074677 Japan ST-246 suspension formulations May 24, 2022 February 15, 2037 JP 7297858 Japan ST-246 suspension formulations June 16, 2023 February 15, 2037 JP 7681393 Japan Amorphous Tecovirimat preparation May 14, 2025 July 11, 2034 BR 112012023743-8 Brazil Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs February 18, 2020 March 23, 2031 BR 112013002646-4 Brazil Liquid Pharmaceutical formulations containing ST-246 January 4, 2022 August 2, 2031 CN 2011800245893 China Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs August 26, 2015 March 23, 2031 CN 2013800429237 China Methods of preparing Tecovirimat June 20, 2017 August 14, 2033 CN 2017103075357 China Methods of preparing Tecovirimat March 6, 2020 August 14, 2033 CN 2014800653387 China Rehydration of micronized Tecovirimat monohydrate February 7, 2020 November 14, 2034 CN 202010101449 China Methods of preparing Tecovirimat June 20, 2023 August 14, 2033 CA 2685153 Canada Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 December 16, 2014 April 23, 2027 CA 2866037 Canada Chemicals, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases May 16, 2017 April 23, 2027 CA 2807528 Canada Liquid Pharmaceutical formulations containing ST-246 September 25, 2018 August 2, 2031 CA 2966466 Canada Use of ST-246 to treat orthopoxvirus infections August 25, 2020 April 23, 2027 CA 2882506 Canada Methods of preparing Tecovirimat October 20, 2020 August 14, 2033 CA 2793533 Canada Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs February 26, 2019 March 23, 2031 CA 2917199 Canada Amorphous Tecovirimat preparation August 31, 2021 July 11, 2034 CA 2930461 Canada Rehydration of micronized Tecovirimat monohydrate August 16, 2022 November 14, 2034 CA 3090294 Canada Methods of preparing Tecovirimat January 24, 2023 August 14, 2033 CA 3128535 Canada Amorphous Tecovirimat preparation October 15, 2024 July 11, 2034 AU 2011232551 Australia Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus February 26, 2015 March 23, 2031 AU 2011285871 Australia Liquid Pharmaceutical formulations containing ST-246 August 6, 2015 August 2, 2031 AU 2013302764 Australia Methods of preparing Tecovirimat April 5, 2018 August 14, 2033 AU 2014290333 Australia Amorphous Tecovirimat preparation February 21, 2019 July 11, 2034 AU 2014353235 Australia Rehydration of micronized Tecovirimat monohydrate August 22, 2019 November 14, 2034 AU 2018201499 Australia Methods of preparing Tecovirimat May 21, 2020 August 14, 2033 AU 2019208252 Australia Rehydration of micronized Tecovirimat monohydrate July 2, 2020 November 14, 2034 AU 20172211295 Australia ST-246 suspension formulations May 2, 2022 February 15, 2037 AU 2020202894 Australia Methods of preparing Tecovirimat July 7, 2022 August 14, 2033 AU 2022202841 Australia Methods of preparing Tecovirimat February 1, 2024 August 14, 2033 AU 2022218556 Australia ST-246 suspension formulations November 28, 2024 February 15, 2037 AP 3221 ARIPO*/Africa Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus April 3, 2015 March 23, 2031 ZA 2012/07141 South Africa Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs June 29, 2016 March 23, 2031 ZA 2013/00930 South Africa Liquid Pharmaceutical formulations containing ST-246 November 25, 2015 August 2, 2031 IL 201736 Israel Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 October 1, 2016 April 23, 2027 IL 236944 Israel Methods of preparing Tecovirimat February 1, 2017 August 14, 2033 IL 242665 Israel Methods of preparing intermediate in the preparation of Tecovirimat February 1, 2020 April 23, 2027 IL 224430 Israel Liquid Pharmaceutical formulations containing ST-246 December 27, 2019 August 2, 2031 IL 242666 Israel Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases December 1, 2018 April 23, 2027 IL 221991 Israel Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs October 1, 2019 March 23, 2031 IL 269370 Israel Compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases December 1, 2020 April 23, 2027 IL 242331 Israel Amorphous Tecovirimat preparation March 1, 2021 July 11, 2034 IL 244731 Israel Rehydration of micronized Tecovirimat monohydrate September 1, 2021 November 14, 2034 IL 282098 Israel Rehydration of micronized Tecovirimat monohydrate April 3, 2023 November 14, 2034 11 Table of Contents IL 260229 Israel ST-246 suspension formulations May 2, 2023 February 15, 2037 BE 1638938 Belgium Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2029 BE 2549871 Belgium Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 BE 2600715 Belgium Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 CH 2549871 Switzerland Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 CH 2600715 Switzerland Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 DE 2549871 Germany Polymorphic forms of ST-246 August 22, 2018 March 23, 2036 DE 2887938 Germany Methods of preparing Tecovirimat January 10, 2018 August 14, 2033 DE 2600715 Germany Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 DE 3321253 Germany Methods of preparing Tecovirimat February 12, 2020 August 14, 2033 DE 3021836 Germany Amorphous Tecovirimat preparation August 27, 2020 July 11, 2034 DE 3043793 Germany Rehydration of micronized Tecovirimat monohydrate January 6, 2021 November 14, 2034 DE 3763702 Germany Amorphous Tecovirimat preparation December 13, 2023 July 11, 2034 DE 3656763 Germany Methods of preparing Tecovirimat December 17, 2025 August 14, 2033 DK 2549871 Denmark Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 DK 2600715 Denmark Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 ES 1638938 Spain Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2029 FR 2887938 France Methods of preparing Tecovirimat January 10, 2018 August 14, 2033 FR 2549871 France Polymorphic forms of ST-246 August 22, 2018 March 22, 2036 FR 2600715 France Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 FR 3321253 France Methods of preparing Tecovirimat February 12, 2020 August 14, 2033 FR 3021836 France Amorphous Tecovirimat preparation August 27, 2020 July 11, 2034 FR 3043793 France Rehydration of micronized Tecovirimat monohydrate January 6, 2021 November 14, 2034 FR 3763702 France Amorphous Tecovirimat preparation December 13, 2023 July 11, 2034 FR 3656763 France Methods of preparing Tecovirimat December 17, 2025 August 14, 2033 GB 2887938 United Kingdom Methods of preparing Tecovirimat January 10, 2018 August 14, 2033 GB 2549871 United Kingdom Polymorphic forms of ST-246 August 22, 2018 March 22, 2036 GB 2600715 United Kingdom Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 12 Table of Contents GB 3321253 United Kingdom Methods of preparing Tecovirimat February 12, 2020 August 14, 2033 GB 3021836 United Kingdom Amorphous Tecovirimat preparation August 27, 2020 July 11, 2034 GB 3043793 United Kingdom Rehydration of micronized Tecovirimat monohydrate January 6, 2021 November 14, 2034 GB 3763702 United Kingdom Amorphous Tecovirimat preparation December 13, 2023 July 11, 2034 GB 3656763 United Kingdom Methods of preparing Tecovirimat December 17, 2025 August 14, 2033 HK 1179824 Hong Kong Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs June 21, 2019 March 23, 2031 HK 1184639 Hong Kong Liquid Pharmaceutical formulations containing ST-246 November 12, 2021 October 28, 2033 IT 502017000078377 Italy Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2029 NL 1638938 Netherlands Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 17, 2029 SE 1638938 Sweden Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2029 *African Regional Intellectual Property Organization ("ARIPO") designated contracting states are as follows: Botswana, Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Sierra Leone, Sudan, Swaziland, Tanzania, Uganda, Zambia, and Zimbabwe. ^Organisation Africaine de la Propriété Intellectuelle ("OAPI") designated contracting states are as follows: Benin, Burkina Faso, Cameroon, the Central African Republic, Chad, DRC, Côte d’Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea-Bissau, Mali, Mauritania, the Niger, Senegal, and Togo.
Certain foreign jurisdictions, including the European Union and Canada, have adopted certain biodefense-specific regulations akin to those available in the United States such as a procedure similar to the “Animal Rule” promulgated by the FDA for review and potential approval of biodefense products.
Certain foreign jurisdictions, including the European Union, United Kingdom and Canada, have adopted certain biodefense-specific regulations akin to those available in the United States such as a procedure similar to the “Animal Rule” promulgated by the FDA for review and potential approval of biodefense products.
An IND application is a summary of the pre-clinical studies that were conducted to characterize the drug, including toxicity and safety studies, information on the drug’s composition and the manufacturing and quality control procedures used to produce the drug, as well as a discussion of the human clinical studies that are being proposed to evaluate the safety and efficacy of the product. 12 Table of Contents The pre-marketing clinical program required for approval by the FDA for a new drug typically involves a time-consuming and costly three-phase process.
An IND application is a summary of the pre-clinical studies that were conducted to characterize the drug, including toxicity and safety studies, information on the drug’s composition and the manufacturing and quality control procedures used to produce the drug, as well as a discussion of the human clinical studies that are being proposed to evaluate the safety and efficacy of the product. 13 Table of Contents The pre-marketing clinical program required for approval by the FDA for a new drug typically involves a time-consuming and costly three-phase process.
As of December 31, 2024, SIGA has purchased more than 12 metric tons of API; as such, SIGA will purchase at least 70% of its internal and external API requirements for TPOXX® from Grace until the end of the term of the agreement (as described below), unless the Company receives an offer to purchase API at a price that Grace is unable to match, in which event SIGA will purchase at least 30% of its internal and external API requirements for TPOXX® from Grace until the Company has fulfilled its delivery obligations under the 19C BARDA Contract.
As of December 31, 2025, SIGA has purchased more than 12 metric tons of API; as such, SIGA will purchase at least 70% of its internal and external API requirements for TPOXX® from Grace until the end of the term of the agreement (as described below), unless the Company receives an offer to purchase API at a price that Grace is unable to match, in which event SIGA will purchase at least 30% of its internal and external API requirements for TPOXX® from Grace until the Company has fulfilled its delivery obligations under the 19C BARDA Contract.
Subsequent to June 1, 2024, only specified procurement contracts for the Current Territory entered into prior to June 1, 2024, continue to involve Meridian invoicing and collecting proceeds, and retaining a fee pursuant to the International Promotion Agreement. 4 Table of Contents Mpox In connection with the 2022 response to a global mpox outbreak, a series of observational and randomized, placebo-controlled clinical trials were initiated to assess the safety and efficacy of TPOXX® in participants with mpox.
Subsequent to June 1, 2024, only specified procurement contracts for the Current Territory entered into prior to June 1, 2024, continue to involve Meridian invoicing and collecting proceeds, and retaining a fee pursuant to the International Promotion Agreement. 5 Table of Contents Mpox In connection with the 2022 response to a global mpox outbreak, a series of observational and randomized, placebo-controlled clinical trials were initiated to assess the safety and efficacy of TPOXX® in participants with mpox.
In addition, pursuant to various statutes and regulations, government contracts can be subject to unilateral termination or modification by the government for convenience in the United States and elsewhere, detailed auditing requirements, statutorily controlled pricing, sourcing and subcontracting restrictions and statutorily mandated processes for adjudicating contract disputes. 14 Table of Contents Availability of Reports and Other Information Our internet address is www.siga.com.
In addition, pursuant to various statutes and regulations, government contracts can be subject to unilateral termination or modification by the government for convenience in the United States and elsewhere, detailed auditing requirements, statutorily controlled pricing, sourcing and subcontracting restrictions and statutorily mandated processes for adjudicating contract disputes. 16 Table of Contents Availability of Reports and Other Information Our internet address is www.siga.com.
Government, including both public health and defense agencies; • foreign governments, including both public health and defense agencies; • NGOs and multinational companies; • healthcare providers, including hospitals and clinics; and • state and local governments, which may be interested in procuring these products to protect, among others, emergency responders, such as police, fire and emergency medical personnel. 7 Table of Contents General With respect to U.S.
Government, including both public health and defense agencies; • foreign governments, including both public health and defense agencies; • NGOs and multinational companies; • healthcare providers, including hospitals and clinics; and • state and local governments, which may be interested in procuring these products to protect, among others, emergency responders, such as police, fire and emergency medical personnel. 8 Table of Contents General With respect to U.S.
On January 10, 2022, the EMA approved SIGA’s Marketing Authorisation Application (MAA) for oral tecovirimat, the same formulation that was approved by the FDA in July 2018 under the brand name TPOXX®. The EMA approval includes labeling for oral tecovirimat indicating its use for the treatment of smallpox, mpox, cowpox, and vaccinia complications following vaccination against smallpox.
On January 10, 2022, the EMA approved SIGA’s Marketing Authorisation Application (MAA) for oral tecovirimat, the same formulation that was approved by the FDA in July 2018 under the brand name TPOXX®, under "exceptional circumstances." The EMA approval includes labeling for oral tecovirimat indicating its use for the treatment of smallpox, mpox, cowpox, and vaccinia complications following vaccination against smallpox.
The U.S. Government is the largest source of development and procurement funding for academic institutions and biopharmaceutical companies conducting medical countermeasure research or developing vaccines, anti-infectives and immunotherapies directed at potential agents of bioterror or biowarfare. For the U.S. Government's fiscal year ended September 30, 2024, the budget for annual spending by the U.S.
Government is the largest source of development and procurement funding for academic institutions and biopharmaceutical companies conducting medical countermeasure research or developing vaccines, anti-infectives and immunotherapies directed at potential agents of bioterror or biowarfare. For the U.S. Government's fiscal year ended September 30, 2025, the budget for annual spending by the U.S.
In addition to the patents listed in the above chart, the principal and material patent applications covering TPOXX® include patent filings in multiple jurisdictions, including the United States, Europe, Asia, and other commercially significant markets. We hold 15 patent applications currently pending with respect to various compositions of TPOXX®, methods of manufacturing, and methods of treatment.
In addition to the patents listed in the above chart, the principal and material patent applications covering TPOXX® include patent filings in multiple jurisdictions, including the United States, Europe, Asia, and other commercially significant markets. We hold 13 patent applications currently pending with respect to various compositions of TPOXX®, methods of manufacturing, and methods of treatment.
Thereafter, this agreement automatically renews on a year-by-year basis unless either party provides four months’ notice of its desire to terminate the agreement prior to the expiration of the term. The Company did not provide notice nor receive notice of termination. As such, the agreement automatically extended on December 31, 2024 to December 31, 2025.
Thereafter, this agreement automatically renews on a year-by-year basis unless either party provides four months’ notice of its desire to terminate the agreement prior to the expiration of the term. The Company did not provide notice nor receive notice of termination. As such, the agreement automatically extended on December 31, 2025 to December 31, 2026.
The 19C BARDA Contract includes: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 32,000 courses (as currently defined within the contract) of IV TPOXX®; and three separate IV FDP Options, each providing for 32,000 courses of final drug product of IV TPOXX®.
The 19C BARDA Contract included: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 32,000 courses (as currently defined within the contract) of IV TPOXX®; and three separate IV FDP Options, each providing for 32,000 courses of final drug product of IV TPOXX®.
The approval process and requirements governing the conduct of clinical trials, product authorization, pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval. Under EU regulatory systems, a company may submit marketing authorization applications either under a centralized or decentralized procedure.
The approval process and requirements governing the conduct of clinical trials, product authorization, pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval. 14 Table of Contents Under EU regulatory systems, a company may submit marketing authorization applications either under a centralized or decentralized procedure.
In addition to the delivery of TPOXX® courses, the contract includes funding from BARDA for a range of activities, including: advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, development for a pediatric formulation, and procurement activities.
In addition to the delivery of TPOXX® courses, the contract includes funding from BARDA for a range of activities, including advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, development of a pediatric formulation, support for manufacturing activities, and procurement activities.
On July 8, 2022, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) approved oral tecovirimat for the treatment of smallpox, mpox, cowpox, and vaccinia complications following vaccination against smallpox in adults and children with a body weight of at least 13kg.
On July 8, 2022, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) approved oral tecovirimat under "exceptional circumstances" for the treatment of smallpox, mpox, cowpox, and vaccinia complications following vaccination against smallpox in adults and children with a body weight of at least 13kg.
The purpose of these randomized clinical trials is to seek to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease.
The purpose of these randomized clinical trials was to seek to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease.
As of December 31, 2024, 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 $25.3 million for other base period activities.
As of December 31, 2025, the Company had received $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS, $4.8 million for the delivery of IV FDP to the Strategic Stockpile, and $31.2 million for other base period activities.
Some improvement versus placebo was observed in patients receiving TPOXX® whose symptoms began seven days or fewer before randomization and patients with severe or grave disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions, however the significance of these data have not been established.
Some improvement versus placebo was observed in patients receiving TPOXX® whose symptoms began five days or fewer before randomization and patients with severe or grave disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions, however the significance of these data has not been established.
Estimates of the total time typically required for carrying out such clinical testing vary between two and 10 years. Upon completion of such clinical testing, a company typically submits an NDA to the FDA that summarizes the results and observations of the drug during the clinical testing.
Estimates of the total time typically required for carrying out such clinical testing vary between two and 10 years. Upon completion of such clinical testing, a company typically submits a New Drug Application ("NDA") to the FDA that summarizes the results and observations of the drug during the clinical testing.
On September 30, 2024, the contract term automatically renewed for a one-year term. 5 Table of Contents Microsize micronizes and tests API for use in oral TPOXX®. The Company’s agreement with Microsize's predecessor was amended on January 11, 2019. The amended term ends on the tenth anniversary of the amendment date. Catalent granulates, encapsulates, and tests oral TPOXX®.
On September 30, 2025, the contract term automatically renewed for a one-year term. 6 Table of Contents Microsize micronizes and tests API for use in oral TPOXX®. The Company’s agreement with Microsize's predecessor was amended on January 11, 2019. The amended term ends on the tenth anniversary of the amendment date. Catalent granulates, encapsulates, and tests oral TPOXX®.
The information in or accessible through the SEC and our website are not incorporated into, and are not considered part of, this filing. 15 Table of Contents
The information in or accessible through the SEC and our website are not incorporated into, and are not considered part of, this filing. 17 Table of Contents
The base period of performance specifies potential payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 10,000 courses (as currently defined within the contract as being 28 vials) of final drug product of IV TPOXX® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities.
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.
In addition to being approved by the FDA, oral TPOXX® (tecovirimat) has received regulatory approval from the European Medicines Agency ("EMA"), Health Canada, the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom, and most recently, in December 2024, the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA").
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").
There are options related to the manufacture of bulk drug substance (“IV BDS Options”), and there are corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA may choose to exercise any, all, or none of these options in its sole discretion.
There were options related to the manufacture of bulk drug substance (“IV BDS Options”), and there were corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA had the sole discretion to choose to exercise any, all, or none of these options.
BARDA has the sole discretion as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option).
BARDA had the sole discretion as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option). To date, BARDA has exercised all three IV BDS options and all three IV FDP options.
Patheon manufactures, tests and packages IV TPOXX®. SIGA agreed that Patheon will be entitled to manufacture at least 80% of IV TPOXX® offered for sale by SIGA during the first three years of the agreement, provided Patheon adheres to reasonable manufacturing standards. Thereafter, the manufacturing percentage will be as mutually agreed upon by the parties.
Patheon manufactures, tests and packages IV TPOXX®. SIGA agreed that Patheon was entitled to manufacture at least 80% of IV TPOXX® offered for sale by SIGA during the first three years of the agreement, provided Patheon adhered to reasonable manufacturing standards. Thereafter, the manufacturing percentage is mutually agreed upon by the parties.
As of December 31, 2024, two of the randomized, placebo-controlled clinical trials reported preliminary topline results: a randomized, placebo-controlled clinical trial in the Democratic Republic of the Congo ("DRC") known as PALM 007 (Tecovirimat for Treatment of Monkeypox Virus - NCT05559099), which is funded and sponsored by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID); and the Study of Tecovirimat for Human Mpox Virus (STOMP) clinical trial (NCT05534984), which is a randomized, placebo-controlled, double-blind study sponsored and funded by NIAID to evaluate the safety and efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive mpox disease that included enrollees from Argentina, Brazil, Japan, Mexico, Peru, Thailand, and the United States.
As of December 31, 2025, three of the randomized, placebo-controlled clinical trials reported topline results: a randomized, placebo-controlled clinical trial in the Democratic Republic of the Congo ("DRC") known as PALM 007 (Tecovirimat for Treatment of Monkeypox Virus - NCT05559099), which was funded and sponsored by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID); the Study of Tecovirimat for Human Mpox Virus (STOMP) clinical trial (NCT05534984), which was a randomized, placebo-controlled, double-blind study also sponsored and funded by NIAID to evaluate the safety and efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive mpox disease that included enrollees from Argentina, Brazil, Japan, Mexico, Peru, Thailand, and the United States; and the UNITY clinical trial (Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease - NCT NCT05597735), which was funded and sponsored by ANRS-Emerging Infectious Diseases, which included enrollees from Switzerland, Brazil, and Argentina.
As of December 31, 2024, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $602.5 million of payments, of which approximately $51.7 million of payments are included within the base period of performance, approximately $519.6 million of payments are related to exercised options and up to approximately $31.2 million of payments are currently specified as unexercised options.
As of December 31, 2025, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $630 million of payments, of which approximately $79.2 million of payments are included within the base period of performance, approximately $545.2 million of payments are related to exercised options and up to approximately $5.6 million of payments are currently specified as unexercised options.
In addition, we may not be able to compete effectively if our product candidates do not satisfy governmental procurement requirements, particularly requirements of the U.S. Government with respect to medical countermeasure products. Human Capital Resources As of February 14, 2025, we had 46 full-time employees.
Furthermore, we may not be able to compete effectively if our product candidates do not satisfy governmental procurement requirements, particularly requirements of the U.S. Government with respect to medical countermeasure products. Human Capital Resources As of February 13, 2026, we had 49 full-time employees.
IV BDS has been used for the manufacture of courses of IV FDP. The options that have been exercised as of December 31, 2024, provide for payments up to approximately $519.6 million.
IV BDS has been used for the manufacture of courses of IV FDP. The options that have been exercised as of December 31, 2025, provide for payments up to approximately $545.2 million.
The timing of a potential submission of a supplemental New Drug Application to the FDA (“Supplemental NDA”) for a smallpox PEP indication for oral TPOXX® will be based on the results of ongoing sample analyses from the immunogenicity trial; the Company is currently targeting a Supplemental NDA submission in the next twelve months. 2 Table of Contents Procurement Contracts with the U.S.
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.
As of December 31, 2024, 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 $51.2 million for the manufacture of courses of IV FDP, of which $20.5 million of payments relate to the manufacture of IV BDS to be used in the manufacture 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 December 31, 2025, there are exercised options for the following activities: payments up to $450.2 million for the manufacture and delivery of up to 1.5 million courses of oral TPOXX®; payments up to $76.8 million for the manufacture of courses of IV FDP; payments of up to approximately $3.6 million to fund post-marketing activities for IV TPOXX®; and payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX®.
As of February 1, 2025, the TPOXX® patent portfolio has seven patent families consisting of 25 U.S. utility patents, 97 issued foreign patents, one U.S. utility patent application, and 14 foreign patent applications. The principal and material issued patents covering TPOXX® are described in the table below.
As of February 20, 2026, the TPOXX® patent portfolio has seven patent families consisting of 26 U.S. utility patents, 101 issued foreign patents, one U.S. utility patent application, and 12 foreign patent applications. The principal and material issued patents covering TPOXX® are described in the table below.
Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects, are more convenient or are less expensive than products that we may develop.
Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects, are more convenient or are less expensive than products that we may develop. In addition, our commercial opportunities could be reduced or eliminated if the funding or procurement behavior of government customers substantially change.
Unexercised options specify potential payments up to approximately $31.2 million in total (if all such options are exercised), of which approximately $5.6 million relates to supportive activities that we currently do not expect to be required.
Unexercised options specify potential payments up to approximately $5.6 million in total (if all such options are exercised), all of which relates to supportive activities that we currently do not expect to be required. The options related to IV TPOXX® were divided into two primary manufacturing steps.
At the end of the above mentioned contract term, this agreement automatically renews for two-year increments unless either party provides twelve months’ notice of its desire to terminate the agreement prior to the expiration of the term. As noted above, PCI provides packaging services for IV TPOXX®. Grace provides the API used in manufacturing of the intravenous formulation.
At the end of the above mentioned contract term, this agreement automatically renews for two-year increments unless either party provides twelve months’ notice of its desire to terminate the agreement prior to the expiration of the term.
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.
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. 2 Table of Contents TPOXX® was authorized under “exceptional circumstances” by the EMA and the MHRA, under the brand name Tecovirimat-SIGA.
The Company estimates that sales of the IV formulation under this contract (under current terms), assuming the remaining IV FDP Option was exercised, would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%. U.S.
The Company estimates that sales of the IV formulation under this contract (under current terms), would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%. U.S. Department of Defense Procurement Contracts In 2024, the Company had sales of approximately $10 million with the U.S.
For international sales in the first and second quarters, Meridian Medical Technologies ("Meridian") was the counterparty to contracts under which the sales were made (see discussion and definition below regarding International Promotion Agreement). For international sales in the third and fourth quarters, the Company was the counterparty to the contracts under which the sales were made.
In the year ended December 31, 2024, the Company had international sales of $23.0 million consisting of deliveries of oral TPOXX® to 13 countries. For international sales in the first and second quarters, Meridian Medical Technologies ("Meridian") was the counterparty to contracts under which the sales were made (see discussion and definition below regarding International Promotion Agreement).
Under the decentralized approval procedure, an applicant submits an application, or dossier, and related materials to the reference member state and concerned member states. The reference member state prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application.
The reference member state prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. Within 90 days of receiving the reference member state’s assessment report, each concerned member state must decide whether to approve the assessment report and related materials.
Since the regulatory framework in the United Kingdom covering the quality, safety and efficacy of pharmaceutical products, clinical trials, marketing authorization, commercial sales and distribution of medicinal products is derived from EU Directives and Regulations, Brexit could materially impact the future regulatory regime which applies to products and the approval of other product candidates in the United Kingdom. 13 Table of Contents Legislation and Regulation Related to Bioterrorism Counteragents and Pandemic Preparedness Because our drug candidates are intended for the treatment of diseases that may result from acts of bioterrorism or biowarfare or for pandemic preparedness, they may be subject to the specific legislation and regulation described below and elsewhere in this Annual Report on Form 10-K.
Since the regulatory framework in the United Kingdom covering the quality, safety and efficacy of pharmaceutical products, clinical trials, marketing authorization, commercial sales and distribution of medicinal products is derived from EU Directives and Regulations, Brexit could materially impact the future regulatory regime which applies to products and the approval of other product candidates in the United Kingdom.
Data analysis is not yet complete for primary endpoint subgroups and detailed secondary and exploratory endpoints. In both studies, TPOXX® exhibited a safety profile comparable to placebo. These safety results are consistent with prior studies and further support the strong safety profile that has been observed with tecovirimat over the past 15 years.
These safety results are consistent with prior studies and further support the strong safety profile that has been observed with tecovirimat over the past 15 years.
The initial marketing authorization is valid for five years, but once renewed is usually valid for an unlimited period. The decentralized procedure provides for approval by one or more “concerned” member states based on an assessment of an application performed by one member state, known as the “reference” member state.
The decentralized procedure provides for approval by one or more “concerned” member states based on an assessment of an application performed by one member state, known as the “reference” member state. Under the decentralized approval procedure, an applicant submits an application, or dossier, and related materials to the reference member state and concerned member states.
Within 90 days of receiving the reference member state’s assessment report, each concerned member state must decide whether to approve the assessment report and related materials. If a member state does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding on all member states.
If a member state does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding on all member states. The initial marketing authorization granted in the EU is valid for five years.
Government, for procuring property or services used in performing, administering or supporting biomedical countermeasure research and development.
Project BioShield provides alternative procedures under the Federal Acquisition Regulation, the general rubric for acquisition of goods and services by the U.S. Government, for procuring property or services used in performing, administering or supporting biomedical countermeasure research and development.
Over the past three years, the Company has received three procurement contracts from the DoD, including a $9 million contract in August 2024, which has been fulfilled. 3 Table of Contents International Sales Activity In the year ended December 31, 2024, the Company had international sales of $23.0 million consisting of deliveries of oral TPOXX® to 13 countries.
All deliveries specified under these contracts have been fulfilled. 4 Table of Contents International Sales Activity In the year ended December 31, 2025, the Company had international sales of $5.8 million consisting of a delivery of oral TPOXX® to one country. The Company was the counterparty to the contract under which these international sales were made.
Department of Defense Procurement Contracts In 2024, the Company had sales of approximately $10 million with the U.S. Department of Defense ("DoD"). Sales consist mostly of delivery of oral TPOXX®, with a minor amount of IV TPOXX® delivered. In 2023, the Company had sales of approximately $11 million with the DoD. Sales consist of delivery of oral TPOXX®.
Department of Defense ("DoD") (also known as the Department of War). Sales consisted mostly of delivery of oral TPOXX®, with a minor amount of IV TPOXX® delivered. Over the past four years, the Company has received three procurement contracts from the DoD, totaling $28 million in value, mostly in connection with the manufacture and delivery of oral TPOXX®.
Project BioShield Project BioShield and related 2006 federal legislation provide procedures for biodefense-related procurement and awarding of research grants, making it easier for HHS to commit funds to countermeasure projects. Project BioShield provides alternative procedures under the Federal Acquisition Regulation, the general rubric for acquisition of goods and services by the U.S.
Legislation and Regulation Related to Bioterrorism Counteragents and Pandemic Preparedness Because our drug candidates are intended for the treatment of diseases that may result from acts of bioterrorism or biowarfare or for pandemic preparedness, they may be subject to the specific legislation and regulation described below and elsewhere in this Annual Report on Form 10-K. 15 Table of Contents Project BioShield Project BioShield and related 2006 federal legislation provide procedures for biodefense-related procurement and awarding of research grants, making it easier for HHS to commit funds to countermeasure projects.
Three randomized clinical trials, UNITY (Switzerland, Brazil, Argentina), Platinum-CAN (Canada), and EPOXI (EU), are enrolling mpox patients. Given the STOMP and PALM007 results and the design similarities across these mpox trials, the Company believes the ongoing trials are likely to yield similar results.
Two other randomized clinical trials, Platinum-CAN (Canada) and EPOXI (EU), which were started in response to the global mpox outbreak, are closed to enrollment and expected to yield similar results, given the design similarities across these trials. Manufacturing SIGA does not have a manufacturing infrastructure and does not intend to develop one for the manufacture of TPOXX®.
Removed
The remaining unexercised options specify payments of up to $25.6 million for the manufacture of courses of IV FDP, of which up to $10.2 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP. The options related to IV TPOXX® are divided into two primary manufacturing steps.
Added
These regulators granted marketing authorizations under “exceptional circumstances” because it was not possible to obtain complete efficacy and safety information about the product due to the rarity of smallpox and other orthopoxviruses and because ethical considerations prevented conducting the necessary clinical studies.
Removed
To date, BARDA has exercised two of the three IV BDS options and two of the three IV FDP options.
Added
The Tecovirimat-SIGA marketing authorizations under “exceptional circumstances” are subject to certain specific obligations to gather additional data post-approval to help confirm the product’s safety and efficacy. All “exceptional circumstances” marketing authorizations are subject to annual reassessments that consider whether data generated pursuant to the specific obligations continue to confirm its positive benefit-risk profile.
Removed
If BARDA decides only to exercise the remaining IV BDS Option, then the Company would receive payments up to $10.2 million; alternatively, if BARDA decides to exercise the remaining IV BDS Option and IV FDP Option, then the Company would receive payments up to $25.6 million. BARDA may also decide not to exercise either remaining option.
Added
These annual reassessments determine whether the product’s marketing authorization should be maintained, changed, suspended, or withdrawn based on its benefit-risk profile. 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.
Removed
For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 32,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP.
Added
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.
Removed
In the year ended December 31, 2023, the Company had international sales of $21.3 million consisting of deliveries of oral TPOXX® to seven countries.
Added
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. The CHMP is expected to meet in March to issue its recommendation.
Removed
An interim analysis of data from the STOMP study showed that TPOXX® did not demonstrate efficacy in time to skin and mucosal lesion resolution compared to placebo in patients with mild to moderate clade II mpox.
Added
We expect the CHMP will confirm the positive benefit-risk balance of Tecovirimat-SIGA as a treatment for smallpox, cowpox, and vaccinia complications, and maintain those indications in the product label. Regarding mpox, based on the results of the mpox clinical trials, we expect the CHMP will recommend withdrawal of the mpox indication.
Removed
Based on this result and additional analyses, the study Data Safety and Monitoring Board (DSMB) recommended to stop enrolling patients in the randomized arms of the study. NIAID accepted this recommendation and subsequently decided to take a similar action in the open label arm of this study, which included severe and at-risk of developing severe disease patients.
Added
In the UK, Tecovirimat-SIGA is undergoing an annual reassessment by the MHRA. This reassessment, which is ongoing, is substantially similar to the EMA’s annual reassessment process and could result in a similar outcome.
Removed
Research Agreements and Grants In July 2019, the Company was awarded a multi-year research contract ultimately valued at approximately $27 million from the DoD to support work in pursuit of a potential label expansion for oral TPOXX® that would include post-exposure prophylaxis ("PEP") of smallpox (such work known as the "PEP Label Expansion Program" and the contract referred to as the "PEP Label Expansion R&D Contract").
Added
Macroeconomic Environment Future macroeconomic volatility, including changes to and uncertainty regarding tariffs and trade policies, could cause cost increases resulting in an adverse effect on the Company’s operating results.
Removed
As of December 31, 2023, the Company invoiced the full amount of available funding. Contracts and grants include, among other things, options that may or may not be exercised at the U.S. Government’s discretion. Moreover, contracts and grants contain customary terms and conditions including the U.S.
Added
The Company’s supply chain was designed to lessen the impact of macroeconomic volatility such as through development of a U.S. domestic supply chain including U.S. production of API and finished product, and minimal reliance on ex-U.S. components for API and oral TPOXX®.
Removed
Government’s right to terminate or restructure a contract or grant for convenience at any time. As such, the Company may not be eligible to receive all available funds. Manufacturing SIGA does not have a manufacturing infrastructure and does not intend to develop one for the manufacture of TPOXX®.
Added
With respect to IV TPOXX®, tariff activity or other trading restrictions involving the U.S. and Europe may materially increase raw material costs for IV TPOXX® and, in turn, may materially increase IV TPOXX® overall manufacturing costs. 3 Table of Contents Procurement Contracts with the U.S.
Removed
Corporate Responsibility and Sustainability SIGA focuses on the health security market and seeks to advance global health through its development and commercial activities, which include (i) delivering medical countermeasures to governments and/or non-governmental organizations ("NGOs") so that governments and/or NGOs can cost-effectively stockpile treatments for potential public health emergencies and (ii) donating therapies to NGOs to treat patients with serious infectious diseases in developing countries or those who are being treated on a compassionate basis and/or within clinical trials. 6 Table of Contents Market for Medical Countermeasures for Biological Threats The market for medical countermeasures reflects continued awareness of the risks and threats of biological outbreaks, including such outbreaks related to global terror and biowarfare activity.
Added
On April 8, 2025, total payments contemplated under the contract with BARDA were increased by $14.3 million to add funding for activities supporting manufacturing. On June 3, 2025, total payments contemplated under the contract with BARDA were increased by $13.2 million in connection with the development of the pediatric formulation of TPOXX®.
Added
For international sales in the third and fourth quarters, the Company was the counterparty to the contracts under which the sales were made. Since the initiation of international sales in 2020, the Company has cumulatively recorded $137 million of oral TPOXX® international revenues.
Added
Similarly, in the STOMP study, tecovirimat did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution for adults with mild to moderate mpox and a low risk of developing severe disease. Additional analyses of subgroups, secondary and exploratory endpoints is ongoing in each of these studies.
Added
Topline data from the UNITY study, which was presented at a medical conference, also showed that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution for patients with mpox who received TPOXX® compared to patients who received placebo. In all three studies, TPOXX® exhibited a safety profile comparable to placebo.
Added
In December 2025, the Company notified Patheon that the term would not be renewed, and the Company would not manufacture additional IV TPOXX® under this agreement once outstanding procurement orders under the BARDA Contract have been completed. The Company is currently working to transition the manufacture of IV TPOXX® to a new third party manufacturing site.
Added
As noted above, PCI provides packaging services for IV TPOXX®. Grace provides the API used in manufacturing of the intravenous formulation. 7 Table of Contents Market for Medical Countermeasures for Biological Threats The market for medical countermeasures reflects continued awareness of the risks and threats of biological outbreaks, including such outbreaks related to global terror and biowarfare activity. The U.S.
Added
Once renewed, the authorization is usually valid for an unlimited period unless the national competent authority or the EMA decides on justified grounds relating to pharmacovigilance, which could include exposure of an insufficient number of patients to the product concerned, to proceed with one additional five-year renewal.
Added
The renewal of a marketing authorization is subject to a re-evaluation of the risk-benefit balance of the product by the national competent authorities or the EMA.
Added
In addition, products in the EU and the UK may be eligible for grant of marketing authorization under “exceptional circumstances” if an applicant for marketing authorization can demonstrate that comprehensive data on the efficacy and safety of the product under normal conditions of use cannot be provided due to certain specified objective and verifiable reasons such as the rarity of the target disease and because ethical considerations prevent the conduct of the necessary clinical studies.
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Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
56 edited+27 added−28 removed125 unchanged
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
56 edited+27 added−28 removed125 unchanged
2024 filing
2025 filing
Biggest changeRegulatory approval by the FDA, which we obtained for oral and IV TPOXX®, or by a foreign regulatory authority such as Health Canada, the European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency, and the Medicines and Healthcare Products Regulatory Agency, which we obtained for oral TPOXX®, does not ensure approval by additional regulatory authorities in other foreign countries or jurisdictions or by the FDA for additional indications or new formulations.
Biggest changeRegulatory approval by the FDA, which we obtained for oral and IV TPOXX®, and by Health Canada, for oral TPOXX®, in each case for the treatment of smallpox, or by additional foreign regulatory authorities such as European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency, and the U.K.
The cash and cash equivalents that we use to meet our cash needs, including working capital and operating expenses, are held in deposit or investment accounts at four financial institutions.
The cash and cash equivalents that we use to meet our cash needs, including working capital and operating expenses, are held in deposit or investment accounts at four financial institutions.
All of our potential drug candidates are prone to the risks of failure inherent in pharmaceutical product development, including the possibility that our drug candidates will not or cannot: • be shown to be safe, non-toxic and effective; • otherwise meet applicable regulatory standards; • receive the necessary regulatory approvals; • develop into commercially viable drugs; • be manufactured or produced economically and on a large scale; • be successfully marketed; • be paid for by governmental procurers or be reimbursed by governmental or private insurers; or • achieve customer acceptance. 23 Table of Contents In addition, third parties may seek to preclude us from marketing our drugs through enforcement of their proprietary or intellectual property rights that we are not aware of, or third parties may succeed in marketing equivalent or superior drug products that do not infringe our intellectual property.
All of our potential drug candidates are prone to the risks of failure inherent in pharmaceutical product development, including the possibility that our drug candidates will not or cannot: • be shown to be safe, non-toxic and effective; • otherwise meet applicable regulatory standards; • receive the necessary regulatory approvals; • develop into commercially viable drugs; • be manufactured or produced economically and on a large scale; • be successfully marketed; • be paid for by governmental procurers or be reimbursed by governmental or private insurers; or • achieve customer acceptance. 26 Table of Contents In addition, third parties may seek to preclude us from marketing our drugs through enforcement of their proprietary or intellectual property rights that we are not aware of, or third parties may succeed in marketing equivalent or superior drug products that do not infringe our intellectual property.
We cannot predict the ultimate impact such events might have on the Company’s business, financial condition and results of operations. 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..
We cannot predict the ultimate impact such events might have on the Company’s business, financial condition and results of operations. 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.
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. 25 Table of Contents The health security markets in which we compete and will compete are highly competitive.
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. 28 Table of Contents The health security markets in which we compete and will compete are highly competitive.
Government contracts; 16 Table of Contents • the business ethics and public integrity obligations that 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 ("FCPA"); and • 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.
Government contracts; 18 Table of Contents • the business ethics and public integrity obligations that 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 ("FCPA"); and • 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.
Slight deviations anywhere in the manufacturing process, including obtaining materials, filling, labeling, packaging, storage, shipping, quality control and testing, some of which all pharmaceutical companies, including SIGA, experience from time to time, may result in lot failures, delay in the release of lots, product recalls or spoilage.
Slight deviations anywhere in the manufacturing process, including obtaining materials, filling, labeling, packaging, storage, shipping, quality control and testing, some of which all pharmaceutical companies, including us, experience from time to time, may result in lot failures, delay in the release of lots, product recalls or spoilage.
If we are not successful in completing the development and commercialization of our drug candidates, whether due to our efforts or due to concerns raised by our governmental regulators or customers, our business could be materially adversely affected. 22 Table of Contents We 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.
If we are not successful in completing the development and commercialization of our drug candidates, whether due to our efforts or due to concerns raised by our governmental regulators or customers, our business could be materially adversely affected. 25 Table of Contents We 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.
In such event, our ability to market and sell such products may be hindered, the commercial success of TPOXX® and other products we develop may be harmed and we may need to expend time, attention and resources addressing such legal or publicity issues, thereby reducing our revenues and having a material adverse impact on us. 18 Table of Contents Our ability to grow our business partly depends on our ability to achieve recurring sales of TPOXX® to customers other than the U.S.
In such event, our ability to market and sell such products may be hindered, the commercial success of TPOXX® and other products we develop may be harmed and we may need to expend time, attention and resources addressing such legal or publicity issues, thereby reducing our revenues and having a material adverse impact on our business. 21 Table of Contents Our ability to grow our business partly depends on our ability to achieve recurring sales of TPOXX® to customers other than the U.S.
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 political leadership, such as the recent change in the U.S.
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 political leadership, such as the latest change in the U.S.
Our general liability policy provides coverage up to annual aggregate limits of $2 million and coverage of $1 million per occurrence. 26 Table of Contents The loss of key personnel or our ability to recruit or retain qualified personnel could adversely affect our results of operations.
Our general liability policy provides coverage up to annual aggregate limits of $2 million and coverage of $1 million per occurrence. 29 Table of Contents The loss of key personnel or our ability to recruit or retain qualified personnel could adversely affect our results of operations.
Any such loss or lack of access to these funds could adversely impact our short-term liquidity and ability to meet our operating expense obligations. 27 Table of Contents Item 1B. Unresolved Staff Comments None.
Any such loss or lack of access to these funds could adversely impact our short-term liquidity and ability to meet our operating expense obligations. 30 Table of Contents Item 1B. Unresolved Staff Comments None.
If we or these third parties fail to comply with applicable regulations, sanctions could be imposed on us which could significantly delay and adversely affect supplies of our drug candidates. Problems related to large-scale commercial manufacturing could cause an increase in costs or shortages of products or a delay in product launches.
If we or these third parties fail to comply with applicable regulations, sanctions could be imposed on us which could significantly delay and adversely affect supplies of our drug candidates. 24 Table of Contents Problems related to large-scale commercial manufacturing could cause an increase in costs or shortages of products or a delay in product launches.
We may not be able to file for or receive necessary regulatory approvals to commercialize our products in new markets, in which case, our addressable market may be reduced and our ability to realize the full potential of our products and 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 maintain existing approvals or may be unable to file for or receive necessary regulatory approvals to commercialize our products in new markets, in which case, our addressable market may be reduced and our ability to realize the full potential of our products and product candidates may be harmed and our business, financial condition, results of operations and prospects may be adversely affected.
Such actions would hinder our ability to meet contractual obligations and could cause material adverse consequences for our business. 21 Table of Contents Risks Related to Product Development Growth of our business may be impacted significantly by our success in completing development and commercialization of drug candidates, new formulations or additional indications for TPOXX®.
Such actions would hinder our ability to meet contractual obligations and could cause material adverse consequences for our business. Risks Related to Product Development Growth of our business may be impacted significantly by our success in completing development and commercialization of drug candidates, new formulations or additional indications for TPOXX®.
The fact that the FDA has approved the oral and IV formulations of TPOXX® does not guarantee that our approach to drug development will be effective or will result in the successful commercialization of the liquid suspension/pediatric formulation of TPOXX®, any new indication such as post-exposure prophylaxis, of TPOXX® or any other drug.
The fact that the FDA has approved the oral and IV formulations of TPOXX® does not guarantee that our approach to drug development will be effective or will result in the successful commercialization of the liquid suspension/pediatric formulation of TPOXX®, any new indication such as post-exposure prophylaxis, of TPOXX® or any other drug we seek to develop.
The development and full commercialization of additional indications for TPOXX® in the U.S., such as use for smallpox post-exposure prophylaxis ("PEP") or treatment of mpox, including the testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries and jurisdictions.
The development and commercialization of additional indications for TPOXX® in the U.S., such as use for smallpox post-exposure prophylaxis ("PEP"), including the testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries and jurisdictions.
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. Such actions would also negatively affect our reputation.
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. Such actions could materially damage our business and could also negatively affect our reputation.
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. As of December 31, 2024, all but one of the options to which most of the contract value of the 19C BARDA Contract is tied have been exercised.
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. As of December 31, 2025, all of the options to which most of the contract value of the 19C BARDA Contract is tied have been exercised.
The success of our business and our operating results for the foreseeable future will be substantially dependent on the U.S. Government’s commitment to maintaining or expanding its stockpile of TPOXX®. Failure to secure and perform additional U.S. Government contracts after the 19C BARDA Contract to substantially maintain or expand the U.S.
The success of our business and our operating results for the foreseeable future will be substantially dependent on the U.S. Government’s commitment to maintaining or expanding its stockpile of TPOXX®. Failure to secure in a timely manner and perform additional U.S. Government contracts after the 19C BARDA Contract to substantially maintain or expand the U.S.
Because pharmaceutical manufacturers are only permitted to commercialize 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 TPOXX® in other formulations.
Because pharmaceutical manufacturers are only permitted to commercialize in the U.S. 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 our ability to sell TPOXX® in other formulations.
Failure to comply with such laws and regulations could adversely affect the Company’s business, reputation, financial condition, or ability to procure government contracts. Indeed, violations of the FCPA can result in significant civil and criminal penalties that can be levied on the Company and its executives.
Failure to comply with such laws and regulations could adversely affect our business, reputation, financial condition, or ability to procure government contracts. Indeed, violations of the FCPA can result in significant civil and criminal penalties that can be levied on us and its executives.
If we or others identify side effects of any approved product, or if manufacturing problems occur: • regulatory approval may be withdrawn; • reformulation of our products, additional clinical trials or other testing or changes in labeling of our products may be required; • changes to or re-approvals of manufacturing facilities used by SIGA may be required; 19 Table of Contents • sales of the affected products may drop significantly; • our reputation in the marketplace may suffer; and • lawsuits, including class action suits, may be brought against us.
If we or others identify side effects of any approved product, or if manufacturing problems occur: • regulatory approval may be withdrawn; • reformulation of our products, additional clinical trials or other testing or changes in labeling of our products may be required; • changes to or re-approvals of manufacturing facilities we use may be required; 22 Table of Contents • sales of the affected products may drop significantly; • our reputation in the marketplace may suffer; and • lawsuits, including class action suits, may be brought against us.
Government, which may expose us to risks associated with conducting business in international markets. An element of our business strategy is to sell TPOXX® internationally to foreign governments on a recurring basis. These non-U.S.
Government, which may increase our exposure to risks associated with conducting business in international markets. An element of our business strategy is to sell TPOXX® internationally to foreign governments on a recurring basis. These non-U.S.
In addition, failure to obtain approval in one jurisdiction may impact our ability to obtain approvals elsewhere.
In addition, failure to obtain or maintain approval in one jurisdiction may impact our ability to obtain approvals elsewhere.
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.
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. We have received FDA approval for the oral and intravenous formulations of TPOXX® in the U.S. for the treatment of smallpox.
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.
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. To market our products in certain foreign jurisdictions, we need to maintain existing regulatory approvals or may need to obtain additional regulatory approvals and comply with numerous and varying regulatory requirements.
Our inability to obtain a new procurement contract to supply TPOXX® to the U.S. Government could cause our business, financial condition, results of operations and prospects to suffer materially. Government-funded contracts often consist of standalone procurement orders or a base period of performance followed by options for the performance of certain future activities.
Government to exercise its options under a new procurement contract to supply TPOXX® to the U.S. Government could cause our business, financial condition, results of operations and prospects to be materially harmed. Government-funded contracts often consist of standalone procurement orders or a base period of performance followed by options for the performance of certain future activities.
For example, in connection with a potential FDA label expansion of oral TPOXX® for an indication covering PEP, we completed an immunogenicity trial in 2023 and originally targeted a supplemental NDA submission in 2024. Because samples from that trial are being reanalyzed by the U.S.
For example, in connection with a potential FDA label expansion of oral TPOXX® for an indication covering PEP, we completed an immunogenicity trial in 2023 and originally targeted a supplemental NDA submission in 2024. Because samples from that trial are being reanalyzed by the U.S. Centers for Disease Control and Prevention which has been impacted by recent U.S.
Although the Company has implemented policies and procedures designed to ensure compliance with applicable laws and regulations, there can be no assurance the Company’s employees, contractors, third parties or agents will not violate such laws and regulations or the Company’s policies and procedures.
Although we have implemented policies and procedures designed to ensure compliance with applicable laws and regulations, there can be no assurance our employees, contractors, third parties or agents will not violate such laws and regulations or our policies and procedures.
In addition, the expansion of our international presence may increase certain risks, which include: • foreign governments imposing withholding or other taxes on remittances and other payments to us or the amount of any such taxes may increase; • potential difficulties enforcing agreements, making product deliveries, satisfying product and process requirements of non-U.S. jurisdictions, collecting receivables and protecting our intellectual property and other assets; • regional safety and security considerations; • increased costs and risks relating to exportation, shipping and transportation of the Company’s products, including the impact of any trade disputes or other trade barriers, such as the imposition of new or increased tariffs; and • increased management and infrastructure costs.
In addition, the expansion of our international presence may increase certain risks, which include: • foreign governments imposing withholding or other taxes on remittances and other payments to us or the amount of any such taxes may increase; • potential difficulties enforcing agreements, making product deliveries, satisfying product and process requirements of non-U.S. jurisdictions, collecting receivables and protecting our intellectual property and other assets; • regional safety and security considerations; • increased costs and risks and uncertainties relating to exportation, shipping and transportation of our products, including the impact of any trade disputes or other trade barriers, such as the imposition and enforceability of new or increased tariffs, any retaliatory actions taken by counties impacted by such tariffs and uncertainties regarding the ability to obtain refunds for previously paid tariffs that have subsequently been invalidated; and • increased management and infrastructure costs.
While we believe our current cash position is strong, our ability to continue to fund future operations will be substantially impacted by remaining cash flows from the 19C BARDA Contract or any new procurement contract with the U.S. Government.
While we believe our current cash position is strong, our ability to continue to fund future operations will be substantially impacted by potential cash flows from any new procurement contract with the U.S. Government. If we fail to enter into a new U.S.
If any such spending bill is not timely passed, a government shutdown may close many federally run operations, and halt work for federal employees unless they are considered essential or such work is separately funded by a continuing resolution or by industry.
If any such spending bill is not timely passed, a government shutdown may close many federally run operations, and halt work for federal employees unless they are considered essential or such work is separately funded by a continuing resolution or by industry. A significant portion of our revenue is derived from contracts with U.S. federal agencies.
Government stockpile of TPOXX® could have a material adverse effect on our long-term business, financial condition, results of operations and prospects. Additionally, the 19C BARDA Contract does not necessarily increase the likelihood that we will secure future comparable contracts with the U.S. Government.
Government stockpile of TPOXX® could have a material adverse effect on our long-term business, financial condition, results of operations, including losses due to potential inventory write-offs, and prospects. Additionally, the 19C BARDA Contract does not necessarily increase the likelihood that we will secure future comparable contracts with the U.S. Government. Government contracts require ongoing funding decisions by governments.
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.
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.
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.
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.
Under the 19C BARDA Contract, we are responsible for the performance of these third-party contractors, and our contracts with these third parties give us certain supervisory and quality control rights, but we do not exercise day-to-day control over their activities.
We currently rely on third-party manufacturers and service providers to provide raw materials and manufacture, package, test and ship TPOXX®. Under the 19C BARDA Contract, we are responsible for the performance of these third-party contractors, and our contracts with these third parties give us certain supervisory and quality control rights, but we do not exercise day-to-day control over their activities.
We expect a substantial percentage of our future operating revenues to come from contracts with the U.S. Government for the provision and maintenance of the stockpile of TPOXX® built under the 19C BARDA Contract. If the U.S. Government does not enter into such a contract, our long-term business, financial condition and operating results could be materially harmed.
Government for the provision and maintenance of the stockpile of TPOXX® built under the 19C BARDA Contract. If the U.S. Government does not enter into such a contract, or if such contract is materially delayed or smaller than the 19C BARDA Contract, our long-term business, financial condition and operating results could be materially harmed.
Government procurement contract or cash flows from such procurement contract are significantly delayed or 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. 20 Table of Contents Risks Related to Manufacturing, Storage and Our Dependence on Third Parties If third parties on whom we rely for manufacturing and raw materials of TPOXX®, and managing our inventory, do not perform as contractually required or as we expect, we may not be able to successfully satisfy our obligations under any contracts, including the 19C BARDA Contract and any future U.S.
Government procurement contract or cash flows from such procurement contract are significantly delayed or 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. 23 Table of Contents Risks Related to Manufacturing, Storage and Our Dependence on Third Parties We currently rely on third parties for manufacturing and raw materials of TPOXX® and for managing our inventory.
We have received FDA approval for the oral and intravenous formulations of TPOXX® in the U.S. for the treatment of smallpox, not the liquid suspension/pediatric formulation or any other formulation.
We have not received FDA approval for the liquid suspension/pediatric formulation or any other formulation of TPOXX®.
Government shutdown could negatively impact our business and liquidity. Each year, the U.S. Congress must pass all spending bills in the federal budget.
Government shutdown could materially adversely affect our business, results of operations, and financial condition. Each year, the U.S. Congress must pass all spending bills in the federal budget.
These forward-looking statements and other information are subject to risks and uncertainties that could cause our actual results to differ materially from our historical results or currently anticipated results, including the following: Risks Related to Our Dependence on Government Contracts Government contracts require ongoing funding decisions by governments.
These forward-looking statements and other information are subject to risks and uncertainties that could cause our actual results to differ materially from our historical results or currently anticipated results, including the following: Risks Related to Our Dependence on Government Contracts We expect a substantial percentage of our future operating revenues to come from contracts with the U.S.
Our ability to maintain existing international customer relationships and contracts as well as generate future international relationships and contracts will depend on our ability to identify, hire and train qualified personnel. At present, we are at the early stages of building out an international marketing organization.
Our ability to maintain existing international customer relationships and contracts as well as generate future international relationships and contracts will depend on our ability to identify, hire and train qualified personnel.
A substantial percentage of our potential future revenues are expected to come from government contracts. The majority of potential revenue under the 19C BARDA Contract, the Company's largest procurement contract, is tied to options all but one of which have been exercised and the remaining option may or may not be exercised at the sole discretion of BARDA.
A substantial percentage of our potential future revenues are expected to come from government contracts. The majority of potential revenue under any future U.S. Government contract will likely be tied to options that may or may not be exercised at the sole discretion of the U.S. Government. Failure of the U.S.
Remaining unexercised options under current government procurement contracts, including the 19C BARDA Contract, are predominately fixed-price. 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 predominantly fixed-price arrangements with potential moderate annual increases.
Government and foreign governments for TPOXX®, as well as contracts for other biodefense product candidates, would also be predominantly fixed-price arrangements with potential moderate annual increases.
Also, increasing use of artificial intelligence may increase the risk of cyber attacks. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs.
If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs, manufacturing or quality systems, or other GxP-regulated activities.
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.
For example, the loss, corruption, or unavailability of clinical trial data, manufacturing data, or quality records - whether maintained by us or by third parties such as CROs or CDMOs - could result in delays in regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
The approval procedure varies among countries and can involve additional testing and differing manufacturing or labeling requirements. Complying with such requirements may take substantial time prior to approval and delay commercial activities in those jurisdictions. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval for expanded indications or new formulations of TPOXX®.
The approval procedures vary among countries and can involve additional testing and differing manufacturing or labeling requirements. Coming into compliance with and maintaining compliance with such requirements may take substantial time, including prior to approval, and delay commercial activities in those jurisdictions.
Government, or if we do, whether the potential revenues under such contract will be favorable. If the remaining option under the 19C BARDA Contract is not exercised, or we are unable to enter into a new contract to supply TPOXX® to the U.S.
There is no guarantee that we will be able to enter into a new contract to supply TPOXX® to the U.S. Government, or if we do, whether the U.S. Government will exercise its options under such new procurement agreement. If the U.S.
Government procurement contracts are mostly set at fixed prices determined at inception of the contract based on estimates of the time, resources and expenses required to perform these contracts. If our estimates are not accurate, we may not be able to earn an adequate return or may incur a loss under these arrangements.
Government fails to exercise its options under such new procurement agreement, if any, our business, financial condition, results of operations and prospects may suffer materially. Government procurement contracts are mostly set at fixed prices determined at inception of the contract based on estimates of the time, resources and expenses required to perform these contracts.
Foreign Corrupt Practices Act (FCPA) and many other global anti-corruption laws, may hold us liable for the actions of our employees as well as those of our third-party partners.
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. Some laws and regulations governing our business, including the FCPA and many other global anti-corruption laws, may hold us liable for the actions of our employees as well as those of our third-party partners.
Government procurement contract, or to develop, obtain approval of and commercialization of other indications of TPOXX® or other drug candidates, could be significantly impaired or delayed. We do not currently have the internal capacity to perform these important functions, and we may not be able to maintain commercial arrangements for these services on reasonable terms.
Government procurement contract, or to develop, obtain approval of and commercialization of other indications of TPOXX® or other drug candidates, could be significantly impaired or delayed.
Failure to obtain regulatory approval of certain indications for TPOXX® may prevent us from commercializing TPOXX® in the United States for the mpox indication or may prevent us from getting procurement orders from the U.S.
Government shutdowns, the Company is now targeting a supplemental NDA submission within the next twelve months. Failure to obtain regulatory approval of the PEP indication may prevent us from getting procurement orders from the U.S.
As of February 1, 2025, the TPOXX® patent portfolio has seven patent families consisting of 25 U.S. utility patents, 97 issued foreign patents, one U.S. utility patent application, and 14 foreign patent applications. With FDA regulatory approval of oral TPOXX® in July 2018, we were awarded seven years of regulatory exclusivity by the U.S.
As of February 20, 2026, the TPOXX® patent portfolio has seven patent families consisting of 26 U.S. utility patents, 101 issued foreign patents, one U.S. utility patent application, and 12 foreign patent applications. We also rely on trade secrets, know-how, continuing technological innovation and licensing opportunities.
If a government shutdown were to occur, we could experience a delay in contract funding decisions by the government. Additionally, we could be materially harmed by any prolonged government shutdown. 17 Table of Contents Our business could be adversely affected by a negative audit by the U.S. Government. U.S.
Any prolonged or repeated shutdowns could have a material adverse effect on our financial condition, results of operations, and ability to execute our strategic objectives. 19 Table of Contents Our business could be adversely affected by a negative audit by the U.S. Government. U.S.
We may not obtain additional foreign regulatory approvals on a timely basis, if at all.
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 be unable to maintain existing regulatory approvals or may not be successful in obtaining additional foreign regulatory approvals on a timely basis, if at all.
Removed
The one remaining option may or may not be exercised in the sole discretion of BARDA. There is no guarantee that the remaining option will be exercised, or if it is exercised, when such exercise will occur. In addition, there is no guarantee that we will be able to enter into a new contract to supply TPOXX® to the U.S.
Added
If our estimates are not accurate, we may not be able to earn an adequate return or may incur a loss under these arrangements. Previously exercised options under our government procurement contracts, including the 19C BARDA Contract, were predominately fixed price. We expect that any future contracts with the U.S.
Removed
Government on favorable terms, if at all, including because levels of government expenditures and authorizations for biodefense decrease or shift to other programs, changes in the U.S. administration, or for any other reason, our business, financial condition, results of operations and prospects may suffer materially.
Added
The U.S. continues to face a changing geopolitical environment, along with certain fiscal and economic challenges, and uncertainty exists regarding how future budget and program decisions will unfold. During periods of federal government shutdowns, many government agencies and contracting offices cease operations or operate at reduced capacity.
Removed
Centers for Disease Control and Prevention, the Company is now targeting a supplemental NDA submission in the next twelve months.
Added
These shutdowns may delay funding decisions, new contract awards, contract modifications, and may result in the suspension of ongoing work under existing contracts. In the event of a prolonged shutdown, we may experience delays in securing new procurement contracts, which could result in reduced revenue.
Removed
In addition, in 2024, data reported from two randomized, placebo-controlled clinical trials studying TPOXX® as a potential treatment for mpox, showed that TPOXX® did not demonstrate improved time to full lesion resolution compared to placebo, the primary endpoint in each trial.
Added
Even after government operations resume, it may take additional time for normal contracting activities to resume. Government shutdowns can also create uncertainty in federal budgeting and procurement priorities, which could reduce future opportunities for our products. The timing and duration of any shutdown are unpredictable, and we cannot estimate the ultimate effect on our business.
Removed
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 U.S. customers other than the U.S. Government.
Added
Medicines and Healthcare Products Regulatory Agency (MHRA), which we obtained for oral TPOXX® for the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against smallpox, does not ensure continued approval in those jurisdictions or approval by additional regulatory authorities in other foreign countries or jurisdictions or by the FDA for additional indications or new formulations.
Removed
In the United States, we currently employ a small, targeted group to support development and business activities related to TPOXX®. We plan to continue our current approach for sales to the U.S. Government of any other biodefense product candidates that we may successfully develop.
Added
The EMA and MHRA approved TPOXX® under “exceptional circumstances” under the brand name Tecovirimat-SIGA. These regulators granted marketing authorizations under “exceptional circumstances” because it was not possible to obtain complete efficacy and safety information about the product due to the rarity of smallpox and other orthopoxviruses and because ethical considerations prevented conducting the necessary clinical studies.
Removed
This approach may prove insufficient to adequately support our development and business activities in the United States. In order to expand our sales of TPOXX® or other product candidates in the U.S., including to U.S. customers other than the U.S.
Added
The Tecovirimat-SIGA marketing authorizations under “exceptional circumstances” are subject to certain specific obligations to gather additional data post-approval to help confirm the product’s safety and efficacy. All “exceptional circumstances” marketing authorizations are subject to annual reassessments that consider whether data generated pursuant to the specific obligations continue to confirm its positive benefit-risk profile.
Removed
Government, we may need to enhance our own sales and marketing capabilities, and/or enter into collaborations with third parties able to perform these services or outsource these functions to third parties.
Added
These annual reassessments determine whether the product’s marketing authorization should be maintained, changed, suspended, or withdrawn based on its benefit-risk profile. 20 Table of Contents 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.
Removed
There is no assurance that we will be able to do so successfully, and even if we are able to do so that it will have a significant impact on our growth or profitability.
Added
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.
Removed
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.
Added
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. The CHMP is expected to meet in March to issue its recommendation.
Removed
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 significant example of recent legislative action is the Inflation Reduction Act of 2022 (the “IRA”), which was signed into law on August 16, 2022.
Added
We expect the CHMP will confirm the positive benefit-risk balance of Tecovirimat-SIGA as a treatment for smallpox, cowpox, and vaccinia complications, and maintain those indications in the product label. Regarding mpox, based on the results of the mpox clinical trials, we expect the CHMP will recommend withdrawal of the mpox indication.
Removed
The IRA, as written, among other changes, gives HHS the ability and authority to directly negotiate with manufacturers the price that Medicare will pay for certain high-priced drugs.
Added
In the UK, Tecovirimat-SIGA is undergoing an annual reassessment by the MHRA. This reassessment, which is ongoing, is substantially similar to the EMA’s annual reassessment process and could result in a similar outcome.
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Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
4 edited+1 added−0 removed6 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
4 edited+1 added−0 removed6 unchanged
2024 filing
2025 filing
Biggest changeItem 1C. Cybersecurity Risk Management and Strategy We regularly assess risks from cybersecurity threats; monitor our information systems for potential vulnerabilities; and test those systems pursuant to our information technology policies, processes, and practices, which are integrated into our overall risk management program.
Biggest changeItem 1C. Cybersecurity Risk Management and Strategy We regularly assess risks from cybersecurity threats, including through periodic risk assessments aligned with recognized cybersecurity risk management frameworks, and monitor our information systems for potential vulnerabilities.
All employees are required to complete cybersecurity trainings each month through online trainings and simulations. We collaborate with third parties to assess the effectiveness of our cybersecurity prevention and response systems and processes.
All employees are required to complete regular cybersecurity training through online courses and simulated exercises. We collaborate with third parties to assess the effectiveness of our cybersecurity prevention and response systems and processes.
To protect our information systems from cybersecurity threats, we use various security tools that are designed to help identify, escalate, investigate, resolve, and recover from security incidents in a timely manner. The Company’s Chief Information Officer is responsible for developing and implementing our information security program and reporting on cybersecurity matters to the Board.
These activities are integrated into our enterprise risk management program and are designed to identify, escalate, investigate, resolve, and recover from cybersecurity incidents in a timely manner. The Company’s Chief Information Officer is responsible for developing and implementing our information security program and reporting on cybersecurity matters to the Board.
These include cybersecurity assessors, consultants, and other external cybersecurity experts to assist in the identification, verification, and validation of cybersecurity risks, as well as to support associated mitigation plans when necessary. We have also developed a third -party cybersecurity risk management process to conduct due diligence on external entities, including those that perform cybersecurity services.
These include cybersecurity assessors, consultants, and other external cybersecurity experts to assist in the identification, verification, and validation of cybersecurity risks, as well as to support associated mitigation plans when necessary.
Added
We have developed a third -party cybersecurity risk management process that applies a risk-based approach to due diligence and oversight of external entities, including vendors and service providers with access to Company systems or sensitive data.
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
5 edited+0 added−0 removed0 unchanged
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
5 edited+0 added−0 removed0 unchanged
2024 filing
2025 filing
Biggest changeThere were no unregistered sales of equity securities during the fiscal year ended December 31, 2024 that have not been previously disclosed in a quarterly report on Form 10-Q or a current report on Form 8-K. 29 Table of Contents Performance Graph The following line graph compares the cumulative total stockholder return through December 31, 2024, assuming reinvestment of dividends, by an investor who invested $100 on December 31, 2019 in each of (i) our common stock; (ii) the Nasdaq Composite; and (iii) the Nasdaq Biotech Composite. 2019 2020 2021 2022 2023 2024 SIGA Technologies, Inc. $ 100 $ 152 $ 158 $ 164 $ 135 $ 159 NASDAQ Composite Index $ 100 $ 144 $ 174 $ 117 $ 167 $ 215 NASDAQ Biotech Composite Index $ 100 $ 126 $ 125 $ 111 $ 115 $ 114 Securities Authorized for Issuance Under Equity Compensation Plans The information required by this item concerning securities authorized for issuance under equity compensation plans is set forth in Item 12, “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.” 30 Table of Contents
Biggest changeThere were no unregistered sales of equity securities during the fiscal year ended December 31, 2025 that have not been previously disclosed in a quarterly report on Form 10-Q or a current report on Form 8-K. 32 Table of Contents Performance Graph The following line graph compares the cumulative total stockholder return through December 31, 2025, assuming reinvestment of dividends, by an investor who invested $100 on December 31, 2020 in each of (i) our common stock; (ii) the Nasdaq Composite; and (iii) the Nasdaq Biotech Composite. 2020 2021 2022 2023 2024 2025 SIGA Technologies, Inc. $ 100 $ 103 $ 107 $ 88 $ 104 $ 116 Nasdaq Composite Index $ 100 $ 121 $ 81 $ 116 $ 150 $ 180 Nasdaq Biotech Composite Index $ 100 $ 99 $ 89 $ 92 $ 91 $ 120 Securities Authorized for Issuance Under Equity Compensation Plans The information required by this item concerning securities authorized for issuance under equity compensation plans is set forth in Item 12, “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.” 33 Table of Contents
The Company did not repurchase any equity securities during the fourth quarter ended December 31, 2024.
The Company did not repurchase any equity securities during the fourth quarter ended December 31, 2025.
We believe that the number of beneficial owners of our common stock is substantially greater than the number of record holders, because a large portion of common stock is held in broker “street names.” On March 12, 2024, the Board declared a special dividend of $0.60 per share on the common stock of the Company.
We believe that the number of beneficial owners of our common stock is substantially greater than the number of record holders, because a large portion of common stock is held in broker “street names.” On April 8, 2025, the Board declared a special dividend of $0.60 per share on the common stock of the Company.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The Company's common stock trades on The Nasdaq Global Market under the symbol "SIGA." There were 34 holders of record as of February 14, 2025.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The Company's common stock trades on The Nasdaq Global Market under the symbol "SIGA." There were 29 holders of record as of February 13, 2026.
The special dividend was paid on April 11, 2024 to shareholders of record at the close of business on March 26, 2024. Any future payments of dividends on our common stock will be determined by our Board and will depend on our business conditions, financial results and other factors our Board deems relevant.
The special dividend was paid on May 15, 2025 to shareholders of record at the close of business on April 29, 2025. Any future payments of dividends on our common stock will be determined by our Board and will depend on our business conditions, financial results and other factors our Board deems relevant.
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
45 edited+21 added−16 removed36 unchanged
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
45 edited+21 added−16 removed36 unchanged
2024 filing
2025 filing
Biggest changeAs of December 31, 2024, a cumulative total of $396.9 million of oral TPOXX® has been delivered to the Strategic Stockpile and accepted, of which approximately $15 million was delivered in the first quarter of 2024, approximately $8 million was delivered in the third quarter of 2024, and approximately $51 million was delivered in the fourth quarter of 2024; a cumulative total of $25.4 million of IV FDP has been delivered to the Strategic Stockpile and accepted, of which approximately $17 million of revenue (including recognition of deferred revenue) was recorded in the second quarter of 2024 and approximately $8 million of revenue (including recognition of deferred revenue) was recorded in the fourth quarter of 2024; $10.3 million has been received for the manufacture of IV BDS (such amount is recorded as deferred revenue); and the Company has been cumulatively reimbursed $9.4 million in connection with post-marketing activities for oral and IV TPOXX®.
Biggest changeAs of December 31, 2025, 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 $10.9 million in connection with post-marketing activities for oral and IV TPOXX®.
Revenue connected with performance obligations related to product delivery and supportive services are recognized at a point in time. Revenue connected with performance obligations related to research and development are recognized over time.
Revenue connected with performance obligations related to product delivery and supportive services are recognized at a point in time. Revenue connected with performance obligations related to research and development and certain product supportive services are recognized over time.
The 19C BARDA Contract includes: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 32,000 courses (as currently defined within the contract) of IV TPOXX®; and three separate IV FDP Options, each providing for 32,000 courses of final drug product of IV TPOXX®.
The 19C BARDA Contract included: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 32,000 courses (as currently defined within the contract) of IV TPOXX®; and three separate IV FDP Options, each providing for 32,000 courses of final drug product of IV TPOXX®.
In addition to the delivery of TPOXX® courses, the contract includes funding from BARDA for a range of activities, including: advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, development for a pediatric formulation, and procurement activities.
In addition to the delivery of TPOXX® courses, the contract includes funding from BARDA for a range of activities, including: advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, development of a pediatric formulation, support for manufacturing activities, and procurement activities.
The purpose of these randomized clinical trials is to seek to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease.
The purpose of these randomized clinical trials was to seek to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease.
As of December 31, 2024, 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 $25.3 million for other base period activities.
As of December 31, 2025, the Company had received $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS, $4.8 million for the delivery of IV FDP to the Strategic Stockpile and $31.2 million for other base period activities.
Some improvement versus placebo was observed in patients receiving TPOXX® whose symptoms began seven days or fewer before randomization and patients with severe or grave disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions, however the significance of these data have not been established.
Some improvement versus placebo was observed in patients receiving TPOXX® whose symptoms began five days or fewer before randomization and patients with severe or grave disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions, however the significance of these data has not been established.
The base period of performance specifies potential payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 10,000 courses (as currently defined within the contract as being 28 vials) of final drug product of IV TPOXX® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities.
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.
Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (filed with the SEC on March 12, 2024) for additional discussion of our financial condition and results of operations for the year ended December 31, 2023, as well as our financial condition and results of operations for the year ended December 31, 2023 compared to the year ended December 31, 2022.
Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (filed with the SEC on March 11, 2025) for additional discussion of our financial condition and results of operations for the year ended December 31, 2024, as well as our financial condition and results of operations for the year ended December 31, 2024 compared to the year ended December 31, 2023.
Our effective tax rate for the year ended December 31, 2024 was 22.2% and differs from the statutory rate of 21% primarily as a result of non-deductible executive compensation under IRC Section 162(m), shortfalls on stock-based compensation, and state and local taxes.
Our effective tax rate for the year ended December 31, 2024 was 22.2% and differs from the statutory rate of 21% primarily as a result of non-deductible executive compensation under IRC Section 162(m), and state and local taxes.
Liquidity and Capital Resources As of December 31, 2024, we had $155.4 million in cash and cash equivalents, compared with $150.1 million at December 31, 2023. 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.
Liquidity and Capital Resources As of December 31, 2025, we had $155.0 million in cash and cash equivalents, compared with $155.4 million at December 31, 2024. We believe that our liquidity and capital resources will be sufficient to meet our anticipated requirements for at least the next twelve months from the issuance of these financial statements.
The remaining $0.3 million of deferred revenue was recognized in the second quarter of 2024 as the IV FDP containing such IV BDS was delivered to and accepted by the Strategic Stockpile. The options that have been exercised as of December 31, 2024, provide for payments up to approximately $519.6 million.
The remaining $0.3 million of deferred revenue was recognized in the second quarter of 2024 as the IV FDP containing such IV BDS was delivered to and accepted by the Strategic Stockpile. The options that have been exercised as of December 31, 2025, provide for payments up to approximately $545.2 million.
These reconciling items include but are not limited to stock-based compensation, deferred income taxes and changes in the fair value of our warrant liability; gains and losses from various transactions and changes in the consolidated balance sheet for working capital from the beginning to the end of the period.
These reconciling items include but are not limited to stock-based compensation, deferred income taxes and gains and losses from various transactions and changes in the consolidated balance sheet for working capital from the beginning to the end of the period.
Recently Issued Accounting Pronouncements For discussion regarding the impact of accounting standards that were recently issued but are not yet effective, on our consolidated financial statements, see Note 2 , Summary of Significant Accounting Policies , to the consolidated financial statements. 36 Table of Contents Results of Operations for the Years ended December 31, 2024 and 2023 Revenues from product sales and supportive services for the years ended December 31, 2024 and 2023 were $133.3 million and $130.7 million, respectively.
Recently Issued Accounting Pronouncements For discussion regarding the impact of accounting standards that were recently issued but are not yet effective, on our consolidated financial statements, see Note 2 , Summary of Significant Accounting Policies , to the consolidated financial statements. 39 Table of Contents Results of Operations for the Years ended December 31, 2025 and 2024 Revenues from product sales and supportive services for the years ended December 31, 2025 and 2024 were $88.0 million and $133.3 million, respectively.
Net cash provided by operations for the years ended December 31, 2024 and 2023 was $48.8 million and $94.8 million, respectively. For the year ended December 31, 2024, net cash increase from operations is due to the receipt of approximately $122.5 million from sales of oral and IV TPOXX® to the U.S.
Net cash provided by operations for the years ended December 31, 2025 and 2024 was $43.5 million and $48.8 million, respectively. For the year ended December 31, 2025, net cash increase from operations is due to the receipt of approximately $105 million from sales of oral and IV TPOXX® to the U.S.
There are options related to the manufacture of bulk drug substance (“IV BDS Options”), and there are corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA may choose to exercise any, all, or none of these options in its sole discretion.
There were options related to the manufacture of bulk drug substance (“IV BDS Options”), and there were corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA had the sole discretion to choose to exercise any, all, or none of these options.
BARDA has the sole discretion as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option).
BARDA had the sole discretion as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option). To date, BARDA has exercised all three IV BDS options and all three IV FDP options.
Revenues from research and development activities for the years ended December 31, 2024 and 2023, were $5.4 million and $9.2 million, respectively. The revenues for the year ended December 31, 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract.
Revenues from research and development activities for the years ended December 31, 2025 and 2024, were $6.5 million and $5.4 million, respectively. The revenues for the years ended December 31, 2025 and 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract.
As of December 31, 2024, two of the randomized, placebo-controlled clinical trials reported preliminary topline results: a randomized, placebo-controlled clinical trial in the Democratic Republic of the Congo ("DRC") known as PALM 007 (Tecovirimat for Treatment of Monkeypox Virus - NCT05559099), which is funded and sponsored by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID); and the Study of Tecovirimat for Human Mpox Virus (STOMP) clinical trial (NCT05534984), which is a randomized, placebo-controlled, double-blind study sponsored and funded by NIAID to evaluate the safety and efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive mpox disease that included enrollees from Argentina, Brazil, Japan, Mexico, Peru, Thailand, and the United States.
As of December 31, 2025, three of the randomized, placebo-controlled clinical trials reported topline results: a randomized, placebo-controlled clinical trial in the Democratic Republic of the Congo ("DRC") known as PALM 007 (Tecovirimat for Treatment of Monkeypox Virus - NCT05559099), which was funded and sponsored by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID); the Study of Tecovirimat for Human Mpox Virus (STOMP) clinical trial (NCT05534984), which was a randomized, placebo-controlled, double-blind study also sponsored and funded by NIAID to evaluate the safety and efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive mpox disease that included enrollees from Argentina, Brazil, Japan, Mexico, Peru, Thailand, and the United States; and the UNITY clinical trial (Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease - NCT NCT05597735), which was funded and sponsored by ANRS-Emerging Infectious Diseases, which included enrollees from Switzerland, Brazil, and Argentina.
As of December 31, 2024, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $602.5 million of payments, of which approximately $51.7 million of payments are included within the base period of performance, approximately $519.6 million of payments are related to exercised options and up to approximately $31.2 million of payments are currently specified as unexercised options.
As of December 31, 2025, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $630 million of payments, of which approximately $79.2 million of payments are included within the base period of performance, approximately $545.2 million of payments are related to exercised options and up to approximately $5.6 million of payments are currently specified as unexercised options.
For the year ended December 31, 2024, we paid a special dividend of approximately $42.7 million as well as approximately $0.8 million associated with the payment of tax obligations for employee common stock tendered. For the year ended December 31, 2023, we paid a special dividend of approximately $32.1 million.
For the year ended December 31, 2024, we paid a special dividend of approximately $42.7 million and spent approximately $0.8 million associated with the payment of tax obligations for employee common stock tendered.
The timing of a potential submission of a supplemental New Drug Application to the FDA (“Supplemental NDA”) for a smallpox PEP indication for oral TPOXX® will be based on the results of ongoing sample analyses from the immunogenicity trial; the Company is currently targeting a Supplemental NDA submission in the next twelve months. 32 Table of Contents Procurement Contracts with the U.S.
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.
Government and international customers, of which approximately $102 million relates to 2024 sales and the remainder to collection of accounts receivable on the December 31, 2023 balance sheet, partially offset by the payment of approximately $30 million of income taxes as well as the use of cash for customary operating activities.
Government and international customers, of which approximately $102 million related to 2024 sales and the remainder to collection of accounts receivable on the December 31, 2023 balance sheet, partially offset by the payment of approximately $30 million of income taxes as well as the use of cash for customary operating activities. 41 Table of Contents On December 31, 2025 and 2024, our accounts receivable balance was approximately $3.3 million and $21.2 million, respectively.
As of December 31, 2024, 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 $51.2 million for the manufacture of courses of IV FDP, of which $20.5 million of payments relate to the manufacture of IV BDS to be used in the manufacture 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 December 31, 2025, there are exercised options for the following activities: payments up to $450.2 million for the manufacture and delivery of up to 1.5 million courses of oral TPOXX®; payments up to $76.8 million for the manufacture of courses of IV FDP; payments of up to approximately $3.6 million to fund post-marketing activities for IV TPOXX®; and payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX®.
In addition to being approved by the FDA, oral TPOXX® (tecovirimat) has received regulatory approval from the European Medicines Agency ("EMA"), Health Canada, the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom, and most recently, in December 2024, the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA").
On May 18, 2022 the FDA approved IV TPOXX® for the treatment of smallpox. In addition to being approved by the FDA, oral TPOXX® (tecovirimat) has received regulatory approval from the European Medicines Agency ("EMA"), Health Canada, the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom, and 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.
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. TPOXX® was authorized under “exceptional circumstances” by the EMA and the MHRA, under the brand name Tecovirimat-SIGA.
Unexercised options specify potential payments up to approximately $31.2 million in total (if all such options are exercised), of which approximately $5.6 million relates to supportive activities that we currently do not expect to be required.
Unexercised options specify potential payments up to approximately $5.6 million in total (if all such options are exercised), all of which relates to supportive activities that we currently do not expect to be required. 36 Table of Contents The options related to IV TPOXX® were divided into two primary manufacturing steps.
In the year ended December 31, 2023, the Company had international sales of $21.3 million consisting of deliveries of oral TPOXX® to seven countries. 34 Table of Contents International Promotion Agreement Under the terms of the current International Promotion Agreement, which was amended on March 27, 2024, and effective June 1, 2024, and further amended on August 30, 2024, the Company has primary responsibility for the advertising, promotion and sale of oral TPOXX® in all geographic regions.
Since the initiation of international sales in 2020, the Company has cumulatively recorded $137 million of oral TPOXX® international revenues. 37 Table of Contents International Promotion Agreement Under the terms of the current International Promotion Agreement, which was amended on March 27, 2024, and effective June 1, 2024, and further amended on August 30, 2024, the Company has primary responsibility for the advertising, promotion and sale of oral TPOXX® in all geographic regions.
The Company estimates that sales of the IV formulation under this contract (under current terms), assuming the remaining IV FDP Option was exercised, would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%. U.S.
The Company estimates that sales of the IV formulation under this contract (under current terms), would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%. U.S. Department of Defense Procurement Contracts In 2024, the Company had sales of approximately $10 million with the U.S.
In addition, we purchased approximately 1.7 million shares of common stock for approximately $11.0 million. Future Cash Requirements As of December 31, 2024, we have outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $2.4 million. 39 Table of Contents
Future Cash Requirements As of December 31, 2025, we have outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $10.1 million. 42 Table of Contents
For international sales in the first and second quarters, Meridian Medical Technologies ("Meridian") was the counterparty to contracts under which the sales were made (see discussion and definition below regarding International Promotion Agreement). For international sales in the third and fourth quarters, the Company was the counterparty to the contracts under which the sales were made.
In the year ended December 31, 2024, the Company had international sales of $23.0 million consisting of deliveries of oral TPOXX® to 13 countries. For international sales in the first and second quarters, Meridian Medical Technologies ("Meridian") was the counterparty to contracts under which the sales were made (see discussion and definition below regarding International Promotion Agreement).
Our accounts receivable balance as of December 31, 2023 primarily reflected sales of oral TPOXX® to the U.S. Government under the 19C BARDA Contract as well as various international countries, of which approximately $11.2 million was received by the Company through the end of February 2024.
Our accounts receivable balance as of December 31, 2025, which was fully received by the Company through the end of February 2026, is primarily related to revenues in connection with the 19C BARDA Contract. Our accounts receivable balance as of December 31, 2024 primarily reflected sales of oral TPOXX® to various international countries and the DoD.
Such revenues for the year ended December 31, 2023 include $97.9 million of oral TPOXX® sales to the U.S. Government under the 19C BARDA Contract; $21.3 million related to international sales of oral TPOXX®; and approximately $10.7 million of oral TPOXX® sales to the DoD.
Such revenues for the year ended December 31, 2025 include $53.3 million of oral TPOXX® sales and $25.8 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA Contract; $5.8 million of oral TPOXX® sales to one international country and $3.1 million of supportive services.
For the year ended December 31, 2024, we recognized a tax provision of $16.9 million on pre-tax income of $76.1 million.
We continue to evaluate the OBBBA and its requirements, but we do not expect a material impact on our financial consolidate statements. For the year ended December 31, 2024, we recognized a tax provision of $16.9 million on pre-tax income of $76.1 million.
Government, DoD and various international customers as well as the manufacture and delivery of IV TPOXX® courses to the U.S. Government. Such costs in 2023 were associated with the manufacturing and delivery of oral TPOXX® to the U.S. Government as well as various international countries.
Such costs in 2025 were primarily associated with the manufacture and delivery of courses of oral and IV TPOXX® to the U.S. Government under the 19C BARDA Contract. Such costs in 2024 were primarily associated with the manufacture and delivery of oral TPOXX® courses to the U.S.
For the year ended December 31, 2023, we recognized a tax provision of $19.7 million on pre-tax income of $87.8 million. Our effective tax rate for the year ended December 31, 2023 was 22.5% and differs from the statutory rate of 21% primarily as a result of non-deductible executive compensation under IRC Section 162(m), and state and local taxes.
Our effective tax rate for the year ended December 31, 2025 was 23.4% and differs from the statutory rate of 21% primarily as a result of non-deductible executive compensation under IRC Section 162(m), and state and local taxes. On July 4, 2025, President Trump signed H.R. 1, the “One Big Beautiful Bill Act” (“OBBBA”) into law.
As such, the Company may not be eligible to receive all available funds. 35 Table of Contents Critical Accounting Estimate The methods, estimates and judgments we use in applying our accounting policies have a significant impact on the results we report in our consolidated financial statements, which we discuss under the heading “Results of Operations” following this section of our Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Two other randomized clinical trials, Platinum-CAN (Canada) and EPOXI (EU), which were started in response to the global mpox outbreak, are closed to enrollment and expected to yield similar results, given the design similarities across these trials. 38 Table of Contents Critical Accounting Estimate The methods, estimates and judgments we use in applying our accounting policies have a significant impact on the results we report in our consolidated financial statements, which we discuss under the heading “Results of Operations” following this section of our Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Data analysis is not yet complete for primary endpoint subgroups and detailed secondary and exploratory endpoints. In both studies, TPOXX® exhibited a safety profile comparable to placebo. These safety results are consistent with prior studies and further support the strong safety profile that has been observed with tecovirimat over the past 15 years.
These safety results are consistent with prior studies and further support the strong safety profile that has been observed with tecovirimat over the past 15 years.
The decrease is primarily attributable to lower direct vendor-related expenses incurred in connection with a decrease in activities under the PEP Label Expansion R&D Contract, partially offset by an increase in compensation expense in connection with new hires. 37 Table of Contents Other income, net for the years ended December 31, 2024 and 2023 was $6.1 million and $4.2 million, respectively.
The expense increase is primarily attributable to an increase in self-funded research and development activity, as well as higher expenses for the implementation of information technology enhancements, higher compensation expense in connection with an increase in headcount, and an increase in the usage of regulatory and related consultants. 40 Table of Contents Other income, net for the years ended December 31, 2025 and 2024 was $6.7 million and $6.1 million, respectively.
Department of Defense Procurement Contracts In 2024, the Company had sales of approximately $10 million with the U.S. Department of Defense ("DoD"). Sales consist mostly of delivery of oral TPOXX®, with a minor amount of IV TPOXX® delivered. In 2023, the Company had sales of approximately $11 million with the DoD. Sales consist of delivery of oral TPOXX®.
Department of Defense ("DoD") (also known as the Department of War). Sales consisted mostly of delivery of oral TPOXX®, with a minor amount of IV TPOXX® delivered. Over the past four years, the Company has received three procurement contracts from the DoD, totaling $28 million in value, mostly in connection with the manufacture and delivery of oral TPOXX®.
Over the past three years, the Company has received three procurement contracts from the DoD, including a $9 million contract in August 2024, which has been fulfilled. International Sales Activity In the year ended December 31, 2024, the Company had international sales of $23.0 million consisting of deliveries of oral TPOXX® to 13 countries.
All deliveries specified under these contracts have been fulfilled. International Sales Activity In the year ended December 31, 2025, the Company had international sales of $5.8 million consisting of a delivery of oral TPOXX® to one country. The Company was the counterparty to the contract under which these international sales were made.
Cost of sales and supportive services for the years ended December 31, 2024 and 2023 were $31.3 million and $17.8 million, respectively. Such costs in 2024 were primarily associated with the manufacture and delivery of oral TPOXX® courses to the U.S.
The increase of $1.1 million of revenue is primarily related to an increase in reimbursable activities under the 19C BARDA Contract. Cost of sales and supportive services for the years ended December 31, 2025 and 2024 were $29.7 million and $31.3 million, respectively.
The increase of $3.1 million reflects higher compensation expense, including stock-based compensation, associated with the hiring of multiple executive officers in 2024. Research and development expenses were $12.3 million for the year ended December 31, 2024, a decrease of approximately $4.1 million from the $16.4 million incurred during the year ended December 31, 2023.
Such decreases are partially offset by an increase in business development costs. Research and development expenses were $20.0 million for the year ended December 31, 2025, an increase of approximately $7.7 million from the $12.3 million incurred during the year ended December 31, 2024.
The difference in costs between years is primarily due to the inclusion of IV TPOXX® in 2024 sales; manufacturing costs for IV TPOXX® are significantly higher than manufacturing costs for oral TPOXX®. Selling, general and administrative expenses for the years ended December 31, 2024 and 2023 were $25.1 million and $22.0 million, respectively.
Government, DoD and various international customers as well as the manufacture and delivery of IV TPOXX® courses to the U.S. Government. Selling, general and administrative expenses for the years ended December 31, 2025 and 2024 were $21.2 million and $25.1 million, respectively.
The remaining amounts of the receivable balance were collected during the second quarter of 2024. Investing Activities We used $42,450 and $21,686 for capital expenditures for the years ended December 31, 2024 and 2023, respectively. Financing Activities Cash used in financing activities for the years ended December 31, 2024 and 2023 was $43.5 million and $43.4 million, respectively.
Investing Activities We used $355,009 and $42,450 for capital expenditures for the years ended December 31, 2025 and 2024, respectively. Capital expenditures in 2025 were made in connection with the purchase of equipment related to future IV TPOXX® manufacturing.
Removed
On May 18, 2022 the FDA approved IV TPOXX® for the treatment of smallpox.
Added
These regulators granted marketing authorizations under “exceptional circumstances” because it was not possible to obtain complete efficacy and safety information about the product due to the rarity of smallpox and other orthopoxviruses and because ethical considerations prevented conducting the necessary clinical studies.
Removed
The remaining unexercised options specify payments of up to $25.6 million for the manufacture of courses of IV FDP, of which up to $10.2 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP. 33 Table of Contents The options related to IV TPOXX® are divided into two primary manufacturing steps.
Added
The Tecovirimat-SIGA marketing authorizations under “exceptional circumstances” are subject to certain specific obligations to gather additional data post-approval to help confirm the product’s safety and efficacy. All “exceptional circumstances” marketing authorizations are subject to annual reassessments that consider whether data generated pursuant to the specific obligations continue to confirm its positive benefit-risk profile.
Removed
To date, BARDA has exercised two of the three IV BDS options and two of the three IV FDP options.
Added
These annual reassessments determine whether the product’s marketing authorization should be maintained, changed, suspended, or withdrawn based on its benefit-risk profile. 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.
Removed
If BARDA decides only to exercise the remaining IV BDS Option, then the Company would receive payments up to $10.2 million; alternatively, if BARDA decides to exercise the remaining IV BDS Option and IV FDP Option, then the Company would receive payments up to $25.6 million. BARDA may also decide not to exercise either remaining option.
Added
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.
Removed
For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 32,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP.
Added
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. The CHMP is expected to meet in March to issue its recommendation.
Removed
An interim analysis of data from the STOMP study showed that TPOXX® did not demonstrate efficacy in time to skin and mucosal lesion resolution compared to placebo in patients with mild to moderate clade II mpox.
Added
We expect the CHMP will confirm the positive benefit-risk balance of Tecovirimat-SIGA as a treatment for smallpox, cowpox, and vaccinia complications, and maintain those indications in the product label. Regarding mpox, based on the results of the mpox clinical trials, we expect the CHMP will recommend withdrawal of the mpox indication.
Removed
Based on this result and additional analyses, the study Data Safety and Monitoring Board (DSMB) recommended to stop enrolling patients in the randomized arms of the study. NIAID accepted this recommendation and subsequently decided to take a similar action in the open label arm of this study, which included severe and at-risk of developing severe disease patients.
Added
In the UK, Tecovirimat-SIGA is undergoing an annual reassessment by the MHRA. This reassessment, which is ongoing, is substantially similar to the EMA’s annual reassessment process and could result in a similar outcome.
Removed
Three randomized clinical trials, UNITY (Switzerland, Brazil, Argentina), Platinum-CAN (Canada), and EPOXI (EU), are enrolling mpox patients. Given the STOMP and PALM007 results and the design similarities across these mpox trials, the Company believes these ongoing trials are likely to yield similar results.
Added
Macroeconomic Environment Future macroeconomic volatility, including changes to and uncertainty regarding tariffs and trade policies, could cause cost increases resulting in an adverse effect on the Company’s operating results.
Removed
Research Agreements and Grants In July 2019, the Company was awarded a multi-year research contract ultimately valued at approximately $27 million from the DoD to support work in pursuit of a potential label expansion for oral TPOXX® that would include post-exposure prophylaxis ("PEP") of smallpox (such work known as the "PEP Label Expansion Program" and the contract referred to as the "PEP Label Expansion R&D Contract").
Added
The Company’s supply chain was designed to lessen the impact of macroeconomic volatility such as through development of a U.S. domestic supply chain including U.S. production of API and finished product, and minimal reliance on ex-U.S. components for API and oral TPOXX®.
Removed
As of December 31, 2023, the Company invoiced the full amount of available funding, and as a result, there is no remaining revenue to be recognized in the future under the PEP Label Expansion R&D Contract.
Added
With respect to IV TPOXX®, tariff activity or other trading restrictions involving the U.S. and Europe may materially increase raw material costs for IV TPOXX® and, in turn, may materially increase IV TPOXX® overall manufacturing costs. 35 Table of Contents Procurement Contracts with the U.S.
Removed
Revenue from the performance obligation under the PEP Label Expansion R&D Contract was recognized over time using an input method using costs incurred to date relative to total estimated costs at completion. Contracts and grants include, among other things, options that may or may not be exercised at the U.S. Government’s discretion.
Added
On April 8, 2025, total payments contemplated under the contract with BARDA were increased by $14.3 million to add funding for activities supporting manufacturing. On June 3, 2025, total payments contemplated under the contract with BARDA were increased by $13.2 million in connection with the development of the pediatric formulation of TPOXX®.
Removed
Moreover, contracts and grants contain customary terms and conditions including the U.S. Government’s right to terminate or restructure a contract or grant for convenience at any time.
Added
For international sales in the third and fourth quarters, the Company was the counterparty to the contracts under which the sales were made.
Removed
The revenue for the year ended December 31, 2023, were mostly earned in connection with performance of research and development activities under the PEP Label Expansion R&D Contract and the 19C BARDA Contract. The decrease of $3.8 million of revenue is related to the completion of billable activities under the PEP Label Expansion R&D Contract in 2023.
Added
Similarly, in the STOMP study, tecovirimat did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution for adults with mild to moderate mpox and a low risk of developing severe disease. Additional analyses of subgroups, secondary and exploratory endpoints is ongoing in each of these studies.
Removed
The increase relates to interest income earned on cash and cash equivalents as the average cash balance during the year ended December 31, 2024 was higher than in 2023. Additionally, the average investment return rates in the year ended December 31, 2024 were higher than those in 2023.
Added
Topline data from the UNITY study, which was presented at a medical conference, also showed that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution for patients with mpox who received TPOXX® compared to patients who received placebo. In all three studies, TPOXX® exhibited a safety profile comparable to placebo.
Removed
For the year ended December 31, 2023, the receipt of substantially all of the $45 million of accounts receivable as of December 31, 2022, the receipt of approximately $111 million of 2023 product sales of oral TPOXX®, as well as approximately $10 million received in connection with IV BDS deferred revenue was partially offset by the use of cash to proactively build inventory, and for operating activities. 38 Table of Contents On December 31, 2024 and 2023, our accounts receivable balance was approximately $21.2 million (which includes approximately $0.5 million of unbilled receivables) and $21.1 million, respectively.
Added
The net decrease of approximately $3.9 million primarily reflects a decrease in international promotion fees related to a combination of the amendment to the International Promotion Agreement with Meridian and lower international activity in 2025, as well as lower professional service and consulting costs, in addition to lower compensation expense associated with the nonrecurrence in 2025 of certain one-time payments and equity grants that occurred in 2024 in connection with new hires.
Removed
Our accounts receivable balance as of December 31, 2024 primarily reflects sales of oral TPOXX® to various international countries and the DoD, of which approximately $20.1 million was received by the Company through the end of February 2025. The remaining amounts of the receivable balance are expected to be collected during the first or second quarter of 2025.
Added
These amounts reflect interest income earned on cash and cash equivalents. For the year ended December 31, 2025, we recognized a tax provision of $7.1 million on pre-tax income of $30.4 million.
Added
The OBBBA makes permanent many of the provisions previously enacted as part of the 2017 Tax Cut and Jobs Act that were set to expire at the end of 2025 and includes other changes to certain U.S. corporate tax provisions including (i) the restoration of immediate expensing for domestic research and development expenditures, (ii) the reinstatement of 100% bonus depreciation for qualified property and (iii) favorably modifying the section 163(j) interest limitation (similar to EBITDA).
Added
FASB Topic 740, “Income Taxes”, requires the tax effects of changes in tax laws or rates be recognized in the period in which the law is enacted. The enactment of the OBBBA did not have a material impact on the Company’s effective tax rate.
Added
Government and international customers, of which approximately $85 million relates to 2025 sales and the remainder to collection of accounts receivable on the December 31, 2024 balance sheet, 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.
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Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Market Risk — interest-rate, FX, commodity exposure
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Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Market Risk — interest-rate, FX, commodity exposure
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2024 filing
2025 filing
Biggest changeAs such, we believe that the securities we hold are subject to market risk, changes in the financial standing of the issuer of such securities and our interest income is sensitive to changes in the general level of U.S. interest rates. 40 Table of Contents
Biggest changeAs such, we believe that the securities we hold are subject to market risk, changes in the financial standing of the issuer of such securities and our interest income is sensitive to changes in the general level of U.S. interest rates. 43 Table of Contents