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What changed in SIGA TECHNOLOGIES INC's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of SIGA TECHNOLOGIES INC's 2023 and 2024 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 2024 report.

+250 added−273 removedSource: 10-K (2025-03-11) vs 10-K (2024-03-12)

Top changes in SIGA TECHNOLOGIES INC's 2024 10-K

250 paragraphs added · 273 removed · 193 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

53 edited+23 added−35 removed76 unchanged
Biggest changePatent 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 7687641 United States Method of manufacturing ST-246 March 30, 2010 September 27, 2024 US 8124643 United States Composition of matter for the ST-246 compound and Pharmaceutical compositions containing ST-246 February 28, 2012 June 18, 2024 US 7956197 United States Method of manufacturing ST-246 June 7, 2011 June 18, 2024 US 8530509 United States Pharmaceutical compositions containing a mixture of compounds including ST-246 September 10, 2013 June 18, 2024 9 Table of Contents US 8802714 United States Method of treating orthopoxvirus infection with a mixture of compounds including ST-246 August 12, 2014 June 18, 2024 US 9045418 United States Method of manufacturing ST-246 June 2, 2015 June 18, 2024 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 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 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 4884216 Japan Therapeutic agent for treating orthopoxvirus including ST-246, pharmaceutical composition of matter for the ST-246 compound and method of manufacturing ST-246 December 16, 2011 June 18, 2024 JP 5657489 Japan Method of manufacturing ST-246 December 5, 2014 June 18, 2024 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 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 2529761 Canada Use of ST-246 to treat orthopoxvirus infection, pharmaceutical compositions containing ST-246 and composition of matter for the ST-246 compound August 13, 2013 June 18, 2024 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 AU 2004249250 Australia Method of treating orthopoxvirus infection, pharmaceutical composition containing ST-246 and composition of matter for the ST-246 compound March 29, 2012 June 18, 2024 AU 2007351866 Australia Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 January 10, 2013 June 18, 2024 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 2012268859 Australia Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 August 18, 2016 June 18, 2024 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 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 AT 1638938 Austria Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 BE 1638938 Belgium Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 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 1638938 Switzerland Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 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 1638938 Germany Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 DE 2549871 Germany Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 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 1638938 Denmark Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 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 FI 1638938 Finland Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 FR 1638938 France Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 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 23, 2031 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 1638938 United Kingdom Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 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 23, 2031 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 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 IE 1638938 Ireland Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 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 PL 1638938 Poland Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 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.
Biggest changePatent 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.
As such, until June 28, 2027, SIGA will purchase all of its requirements for bulk product under the 19C BARDA Contract from Catalent. PCI provides packaging services in connection with oral TPOXX®. Additionally, PCI has contracted with the Company to provide packaging services in connection with the intravenous formulation of TPOXX®.
As such, until June 28, 2027, SIGA will purchase all of its requirements for bulk product for oral TPOXX® under the 19C BARDA Contract from Catalent. PCI provides packaging services in connection with oral TPOXX®. Additionally, PCI has contracted with the Company to provide packaging services in connection with the intravenous formulation of TPOXX®.
The FDA has indicated that approval for therapeutic use of TPOXX® for smallpox was determined under the “Animal Rule.” Once the product is approved for sale, FDA regulations govern the manufacturing and marketing activities, and a post-marketing testing and surveillance program may be required to monitor a product’s usage and effects.
The FDA has indicated that approval for therapeutic use of TPOXX® for smallpox was determined under the “Animal Rule.” Once a product is approved for sale, FDA regulations govern the manufacturing and marketing activities, and a post-marketing testing and surveillance program may be required to monitor a product’s usage and effects.
Item 1. Business Overview SIGA Technologies, Inc. is referred to throughout this report as “SIGA,” “the Company,” “we” or “us.” We are a commercial-stage pharmaceutical company. The Company sells its lead product, TPOXX® (“oral TPOXX®,” also known as "tecovirimat" in certain international markets), to the U.S. Government and international governments (including government affiliated entities).
Item 1. Business Overview SIGA Technologies, Inc. is referred to throughout this report as “SIGA,” “the Company,” “we” or “us.” We are a commercial-stage pharmaceutical company. The Company sells its lead product, TPOXX® (“oral TPOXX®,” also known as "tecovirimat," "Tecovirimat SIGA," or "TEPOXX (tecovirimat)" in certain international markets), to the U.S. Government and international governments (including government affiliated entities).
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. 14 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. 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.
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.
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.
As of December 31, 2023, 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, 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.
Grace and Company (“Grace”), who acquired the assets of Albemarle's Fine Chemistry Services Business in 2021; Microsize, formerly known as Powdersize, LLC and renamed following a change of control transaction; Catalent Pharma Solutions LLC (“Catalent”); and Packaging Coordinators, LLC ("PCI"). SIGA has had manufacturing agreements with Grace and a predecessor owner (Albemarle) since 2011.
Grace and Company (“Grace”), which acquired the assets of Albemarle's Fine Chemistry Services Business in 2021; Microsize, formerly known as Powdersize, LLC and renamed following a change of control transaction; Catalent Pharma Solutions LLC (“Catalent”); and Packaging Coordinators, LLC ("PCI"). SIGA has had manufacturing agreements with Grace and a predecessor owner (Albemarle) since 2011.
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, 2023, the budget for annual spending by the U.S.
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.
Since 2007, the Secretary of HHS has issued nine declarations under the PREP Act to protect from liability countermeasures that are necessary to prepare the nation for potential pandemics or epidemics, including a declaration on October 10, 2008 that provides immunity from tort liability as it relates to smallpox.
Since 2007, the Secretary of HHS has issued twelve declarations under the PREP Act to protect from liability countermeasures that are necessary to prepare the nation for potential pandemics or epidemics, including a declaration on October 10, 2008 that provides immunity from tort liability as it relates to smallpox.
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, Australia, and other commercially significant markets. We hold 18 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 15 patent applications currently pending with respect to various compositions of TPOXX®, methods of manufacturing, and methods of treatment.
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®, 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 for a pediatric formulation, and procurement activities.
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 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.
As of December 31, 2023, 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, $4.3 million for the delivery of IV FDP to the Strategic Stockpile, and $22.1 million for other base period activities.
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.
International Promotion Agreement Under the terms of the International Promotion Agreement, as amended, which has an initial term that expires on May 31, 2024, Meridian was granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States (the “Territory”), and Meridian has agreed not to commercialize any competing product, as defined in the International Promotion Agreement, in the specified field of use in the Territory.
Under the terms of the original International Promotion Agreement ("Pre-amendment International Promotion Agreement"), which had an initial term that expired on May 31, 2024, Meridian had been granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States (the “Territory”), and Meridian agreed not to commercialize any competing product, as defined in the Pre-amendment International Promotion Agreement, in the specified field of use in the Territory.
If BARDA decides to only 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.
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.
As of December 31, 2023, 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 $407.1 million of payments are related to exercised options and up to approximately $143.7 million of payments are currently specified as unexercised options.
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.
Our current and potential competitors include many major pharmaceutical companies, many of which have significant financial, technical and marketing resources. Biotechnology and other pharmaceutical competitors in the medical countermeasure sector include, but are not limited to, Emergent BioSolutions Inc. and Bavarian Nordic A/S.
Competition The biotechnology and pharmaceutical industries are characterized by rapidly evolving technology and intense competition. Our current and potential competitors include many major pharmaceutical companies, many of which have significant financial, technical and marketing resources. Biotechnology and other pharmaceutical competitors in the medical countermeasure sector include, but are not limited to, Emergent BioSolutions Inc. and Bavarian Nordic A/S.
There are exercised options for the following activities: payments up to $337.7 million for the manufacture and delivery of up to 1.1 million courses of oral TPOXX®; payments up to $51.2 million for the manufacture of courses of IV FDP, of which $20.4 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, 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®.
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 has automatically extended to December 31, 2024. Patheon manufactures, tests and packages IV TPOXX®.
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.
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 and Research Facilities As of February 15, 2024, we had 45 full-time employees.
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.
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%. Under the terms of this contract, exercise of procurement options is at the sole discretion of BARDA.
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.
SIGA seeks to advance global public 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.
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.
IV BDS has been used for the manufacture of courses of IV FDP. The options that have been exercised to date provide for payments up to approximately $407.1 million.
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.
The Company's agreement with Roquette has no minimum amount of manufacturing services that must be used. The Company’s agreement with Roquette had an initial term that ended on December 31, 2023.
(“Roquette”); Patheon Manufacturing Services LLC (“Patheon”); and PCI. Roquette provides an excipient used in the manufacturing of IV TPOXX®. The Company's agreement with Roquette has no minimum amount of manufacturing services that must be used. The Company’s agreement with Roquette had an initial term that ended on December 31, 2023.
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. 15 Table of Contents Availability of Reports and Other Information We file annual, quarterly, and current reports, proxy statements, and other documents with the U.S.
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.
Department of Health and Human Services ("HHS") for activities related to advanced development and procurement of medical countermeasures for biodefense-related biological threats to civilian populations was more than $2.7 billion.
Department of Health and Human Services ("HHS") for activities related to advanced development and procurement of medical countermeasures for biodefense-related biological threats to civilian populations was more than $2.5 billion. We believe that potential markets for the sale of medical countermeasures include: • The U.S.
The MAA was filed under the centralized application process, which, upon approval, enables sales, including procurement for stockpiling, of oral tecovirimat in all European Union (EU) member states, as well as Norway, Iceland, and Liechtenstein.
The MAA was filed under the centralized application process, which, upon approval, enables sales, including procurement for stockpiling, of oral tecovirimat in all EU Member States, as well as Norway, Iceland, and Liechtenstein. The United Kingdom left the European Union on January 31, 2020 (commonly referred to as “Brexit”), with a transitional period that expired on December 31, 2020.
We believe that potential markets for the sale of medical countermeasures include: • The 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. government contracts, we receive cash payments on a monthly basis, as services are performed or goods are purchased.
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.
For purposes of this disclosure, contribution margin (in amount) represents international product sales less applicable cost of sales and the Meridian fee (which is included within selling, general and administrative expenses within the income statement). 5 Table of Contents 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").
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").
As of January 17, 2024, the TPOXX® patent portfolio has seven patent families consisting of 30 U.S. utility patents, 109 issued foreign patents, two U.S. utility patent applications, and 16 foreign patent applications. The principal and material issued patents covering TPOXX® are described in the table below.
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.
In the first two months of 2024 ended February 29, 2024, approximately $15 million of oral TPOXX® was delivered to the Strategic Stockpile. Unexercised options specify potential payments up to approximately $143.7 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 $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.
The United Kingdom left the European Union on January 31, 2020 (commonly referred to as “Brexit”), with a transitional period that expired on December 31, 2020. The United Kingdom and the European Union entered into a trade agreement known as the Trade and Cooperation Agreement, which went into effect on January 1, 2021.
The United Kingdom and the European Union entered into a trade agreement known as the Trade and Cooperation Agreement, which went into effect on January 1, 2021.
The fee Meridian retains pursuant to the International Promotion Agreement is a specified percentage of the collected proceeds of sales of oral TPOXX®, net of certain expenses, for calendar years in which customer collected amounts net of such expenses are less than or equal to a specified threshold, and a higher specified percentage of such collected net proceeds for calendar years in which such net collected amounts exceed the specified threshold.
Sales to international customers pursuant to the Pre-amendment International Promotion Agreement were invoiced and collected by Meridian, and such collections were remitted, less Meridian's fees, to the Company under a quarterly process specified in the Pre-amendment International Promotion Agreement; and Meridian was entitled to a specified percentage of the collected proceeds of sales of oral TPOXX®, net of certain expenses, for calendar years in which customer collected amounts net of such expenses were less than or equal to a specified threshold, and to a higher specified percentage of such collected net proceeds for calendar years in which such net collected amounts exceeded the specified threshold.
The Company has been delivering oral TPOXX® to the U.S. Strategic National Stockpile ("Strategic Stockpile") since 2013. In connection with IV TPOXX®, SIGA announced on May 19, 2022 that the FDA approved this formulation for the treatment of smallpox.
On July 13, 2018, the United States Food & Drug Administration (“FDA”) approved the oral formulation of TPOXX® for the treatment of smallpox. The Company has been delivering oral TPOXX® to the U.S. Strategic National Stockpile ("Strategic Stockpile") since 2013. On May 18, 2022 the FDA approved IV TPOXX® for the treatment of smallpox.
SIGA retains ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retains sales and marketing rights with respect to oral TPOXX®. SIGA’s consent is required for the entry into any sales arrangement pursuant to the International Promotion Agreement.
Under the Pre-amendment International Promotion Agreement, as well as the current International Promotion Agreement, SIGA has always retained ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retained sales and marketing rights with respect to oral TPOXX®.
Amounts under contract and grant agreements are not guaranteed and can be canceled at any time for reasons such as non-performance or convenience of the U.S. Government and, if canceled, we will not receive funds for additional work under the agreements.
Government contracts, we receive cash payments on a monthly basis, as services are performed or goods are purchased. Amounts under contracts, including grant agreements, are not guaranteed because those contracts can be canceled at any time for reasons such as non-performance or convenience of the U.S.
The nature and timing of a 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 the trials; the Company is currently targeting a Supplemental NDA filing in 2024.
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.
Additionally, the Company sells the intravenous formulation of TPOXX® ("IV TPOXX®") to the U.S. Government. TPOXX® is an oral formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. On July 13, 2018, the United States Food & Drug Administration (“FDA”) approved oral TPOXX® for the treatment of smallpox.
In certain international markets, the Company may sell TPOXX® through a distributor. Additionally, the Company sells the intravenous formulation of TPOXX® ("IV TPOXX®") to the U.S. Government. TPOXX® is an antiviral drug for the treatment of human smallpox disease caused by variola virus.
There are options for the following activities: payments of up to $112.5 million for the delivery of oral TPOXX® to the Strategic Stockpile; and 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 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.
The options related to IV TPOXX® are divided into two primary manufacturing steps. 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”).
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.
SIGA is required to pay Grace within 45 days of its invoice date. Pricing for API is at a fixed price per kilogram, subject to adjustment for increases in raw material costs and/or general manufacturing costs.
There is no minimum amount of kilograms of API that must be used or acquired by SIGA. Pricing for API is at a fixed price per kilogram, subject to adjustment for increases in raw material costs and/or general manufacturing costs.
With respect to international government contracts, we receive cash payments based on the terms contained within the International Promotion Agreement with Meridian, under which Meridian collects payments from foreign governments. Competition The biotechnology and pharmaceutical industries are characterized by rapidly evolving technology and intense competition.
With respect to international government contracts, we receive cash payments based on the terms of the contract or, for certain contracts entered into by Meridian prior to June 1, 2024, the terms contained within the International Promotion Agreement with Meridian, under which Meridian collects payments from foreign governments.
In addition to being approved by the FDA, oral TPOXX® (tecovirimat) has regulatory approval with the European Medicines Agency ("EMA"), Health Canada and the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom. The EMA and MHRA approved label indication covers the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against 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 most recently, in December 2024, the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA").
With respect to the regulatory approvals by the EMA, MHRA and Health Canada, oral tecovirimat represents the same formulation that was approved by the FDA in July 2018 under the brand name TPOXX®. 2 Table of Contents In connection with a potential FDA label expansion of oral TPOXX® for an indication covering smallpox post-exposure prophylaxis (“PEP”), the Company completed an immunogenicity trial and an expanded safety trial in early 2023.
In connection with a potential FDA label expansion of oral TPOXX® for an indication covering smallpox post-exposure prophylaxis (“PEP”), the Company has completed an immunogenicity trial and an expanded safety trial.
As of December 31, 2023, the Company has cumulatively delivered $323.0 million of oral TPOXX® to the Strategic Stockpile, of which $97.9 million was delivered in the fourth quarter of 2023; has cumulatively received $20.5 million for the completed manufacture of IV BDS; and has been cumulatively reimbursed $7.9 million in connection with post-marketing activities for oral and IV TPOXX®.
As 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®.
In connection with the 2022 global response to an 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. 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.
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®. In addition, Catalent provides services related to commercial stability testing of drug product and preparation for tabulated stability and trend analysis for each time point.
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®.
Intravenous (IV) formulation of TPOXX®: For the manufacture of IV TPOXX® under the BARDA Contract, the Company has agreed to use the following CMOs: Roquette America, Inc. (“Roquette”); Patheon Manufacturing Services LLC (“Patheon”); and PCI. Roquette provides an excipient used in the manufacturing of IV TPOXX®.
The Company’s agreement with PCI had an initial term that ended on March 1, 2022. Since March 2022, this agreement has automatically renewed for successive one-year periods. Intravenous (IV) formulation of TPOXX®: For the manufacture of IV TPOXX® under the BARDA Contract, the Company has agreed to use the following CMOs: Roquette America, Inc.
As of December 31, 2023, there were five randomized, placebo-controlled clinical trials enrolling patients, when available, in locations including the United States, United Kingdom, the Democratic Republic of Congo ("DRC"), South America and Europe. These randomized clinical trials are enrolling patients 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 is to seek to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease.
Copies of each of our filings with the SEC on Form 10-K, Form 10-Q, and Form 8-K, and all amendments to those reports, can be viewed and downloaded free of charge as soon as reasonably practicable after the reports and amendments are electronically filed with or furnished to the SEC.
We make available free of charge on our investor relations website under “Financials” our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy and information statements, our directors’ and officers’ Section 16 reports and any amendments to those reports as soon as reasonably practicable after filing or furnishing such materials to the SEC.
The Company’s agreement with Catalent had an initial term that ended on June 28, 2021. Thereafter, this agreement became subject to automatic renewal for three years unless either party provided six 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.
In addition, Catalent provides services related to commercial stability testing of drug product and preparation for tabulated stability and trend analysis for each time point. The Company’s agreement with Catalent had an initial term that ended on June 28, 2021. Thereafter, this agreement became subject to automatic three year renewals.
U.S. Department of Defense Procurement Contracts On May 12, 2022, the Company announced a contract with the U.S. Department of Defense ("DoD") for the procurement of oral TPOXX® ("DoD Contract #1").
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®.
Removed
The Health Canada approved label indication covers the treatment of smallpox.
Added
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.
Removed
The Company may be able to use data from the trials noted above, as well as from other trials, to potentially pursue an FDA label expansion of oral TPOXX® for an indication covering the treatment of mpox.
Added
With respect to the regulatory approvals by the EMA, PMDA, MHRA and Health Canada, oral tecovirimat represents the same formulation approved by the FDA in July 2018 under the brand name TPOXX®.
Removed
The viability, and timing, of a potential FDA submission for an mpox indication will be impacted by a series of factors, including the magnitude and severity of future mpox cases, the location of future cases, enrollment in clinical trials, and results of randomized, placebo-controlled and observational clinical trials. 3 Table of Contents Procurement Contracts with the U.S.
Added
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.
Removed
BARDA may choose to exercise any, all, or none of these options in its sole discretion.
Added
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.
Removed
The request for proposal that preceded the award of the 19C BARDA Contract indicated that the expected purpose of the contract was to maintain the level of smallpox antiviral preparedness in the Strategic Stockpile.
Added
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.
Removed
Based on prior product delivery activity, and current FDA-approved shelf life of oral TPOXX®, the Company estimates that the remaining options under the 19C BARDA Contract for 363,000 courses of oral TPOXX® (value of $112.5 million) and 32,000 courses of IV FDP (value of $25.6 million) would need to be exercised in 2024 in order to approximately maintain historical stockpile levels of unexpired TPOXX® treatment in the Strategic Stockpile.
Added
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.
Removed
The DoD Contract #1 included a firm commitment for the DoD to procure approximately $3.6 million of oral TPOXX®, and an option, exercisable at the sole discretion of the DoD, for the procurement of an additional approximately $3.8 million of oral TPOXX®.
Added
Meridian has limited, non-exclusive rights to advertise, promote, offer for sale and sell oral TPOXX® in the European Economic Area, Australia, Japan, Switzerland, the United Kingdom and the Association of Southeast Asian Nations and its member states (collectively, the “Current Territory”).
Removed
In the second quarter of 2022, the Company delivered oral TPOXX® to the DoD and recognized revenue of $3.6 million, fulfilling the firm commitment in DoD Contract #1.
Added
Meridian also performs non-promotional activities under specified contracts with third parties entered into prior to June 1, 2024, that provide for the sale of oral TPOXX® in the Current Territory.
Removed
In the third quarter of 2022, the DoD exercised the option for $3.8 million of oral TPOXX® and the Company satisfied its obligation by delivering product in September 2022 and recognized the related revenue. On September 28, 2022, the Company and the DoD signed a new procurement contract ("DoD Contract #2").
Added
The International Promotion Agreement entitles Meridian to receive a fee equal to a high single digit percentage of collected proceeds (whether collected by Meridian or the Company), net of certain expenses, of sales of oral TPOXX® in the Current Territory in the field of use specified in the International Promotion Agreement.
Removed
The DoD Contract #2 included a firm commitment for the DoD to procure approximately $5.1 million of oral TPOXX®, and an option, exercisable at the sole discretion of the DoD for the procurement of an additional approximately $5.5 million of oral TPOXX®.
Added
The International Promotion Agreement has a fixed term that expires on May 31, 2026, with no automatic renewal.
Removed
In March 2023, the Company fulfilled the firm commitment by delivering $5.1 million of oral TPOXX® to the DoD, and recognized the related revenue. Additionally, in March 2023 the DoD exercised the $5.5 million option in DoD Contract #2 for the procurement of oral TPOXX® and the Company delivered these courses to the DoD in the fourth quarter of 2023.
Added
SIGA’s consent is required prior to the entry by Meridian into any sales arrangement pursuant to the International Promotion Agreement.
Removed
In February 2024, DoD Contract #2 was amended and approximately $1 million of oral TPOXX® was ordered by the DoD. 4 Table of Contents International Procurement Contracts In 2023, the Company has delivered, and received acceptance for, approximately $21.3 million of oral TPOXX® to five European countries, one Middle Eastern country, and one Asia Pacific country.
Added
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.
Removed
In the first two months of 2024 ending February 29, 2024, the Company delivered an additional approximately $7 million of oral TPOXX® to six countries in Europe, completing greater than 95% of deliveries under the $18 million of firm commitment orders from 13 countries under the European Commission’s DG HERA (Health Emergency Preparedness and Response Authority) joint procurement mechanism, which was announced by the Company in October 2022.
Added
The PALM 007 study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the DRC with mpox who received TPOXX® compared to patients who received placebo.
Removed
Additionally, $0.7 million of oral TPOXX® was delivered to the Canada Department of National Defence ("CDND") in February 2024. These deliveries were made in connection with orders and contracts under the International Promotion Agreement (defined and discussed below). Through the International Promotion Agreement, Meridian Medical Technologies, Inc.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

80 edited+9 added−3 removed120 unchanged
Biggest changeIf BARDA does not enter into additional contracts after the 19C BARDA Contract to maintain or expand the stockpile of TPOXX®, our long-term business, financial condition and operating results could be materially harmed. The success of our business and our operating results for the foreseeable future will be substantially dependent on the U.S.
Biggest changeWe 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.
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.
If these third parties experience delays, capacity constraints, quality control problems or other disruptions to their operations, including due to supply chain shortages, natural disasters, health emergencies, pandemics, epidemics, civil unrest, labor disputes, cyber events, trade disputes, international conflicts or global hostilities, our ability to ship products to our customers could be impaired and we may fail to meet our requirements for timely delivery.
If these third parties experience delays, capacity constraints, quality control problems or other disruptions to their operations, including due to supply chain shortages, natural disasters, health emergencies, pandemics, epidemics, civil unrest, labor disputes, cyber events, trade disputes or other trade barriers, international conflicts or global hostilities, our ability to ship products to our customers could be impaired and we may fail to meet our requirements for timely delivery.
The approval procedure varies among countries and can involve additional testing and differing manufacturing or labeling requirements. Complying with such requirements may take additional 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 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®.
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. 24 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. 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.
Many potential competitors have manufacturing facilities and established marketing capabilities that may enable such companies to market competing products through existing channels of distribution which could provide a substantial advantage. Product liability lawsuits could cause us to incur liabilities, which could be substantial, and require us to limit commercialization of any products that we may develop.
Many potential competitors have manufacturing facilities and substantial marketing capabilities that may enable such companies to market competing products through existing channels of distribution which could provide a substantial advantage. Product liability lawsuits could cause us to incur liabilities, which could be substantial, and require us to limit commercialization of any products that we may develop.
The commercial success of our current and future drug candidates, new formulations or additional indications for TPOXX®, will depend on many factors, including: • successful development, formulation and cGMP scale-up of drug manufacturing that meets FDA requirements; • successful development of animal models; • successful completion of non-clinical development, including studies in approved animal models; • our ability to pay the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; • successful completion of clinical trials; • receipt of marketing approvals, including the impact of marketing restrictions or required post-approval clinical studies, from the FDA for liquid suspension/pediatric formulations of TPOXX® and similar foreign regulatory authorities; • establishing arrangements on reasonable terms with suppliers and contract manufacturers; • manufacturing stable commercial supplies of drug candidates, including availability of raw materials; • launching commercial sales of the product, whether alone or in collaboration with others; and • acceptance of the product by potential government customers, public health experts, physicians, patients, healthcare payors and others in the medical community.
The commercial success of our current and future drug candidates, new formulations or additional indications for TPOXX®, will depend on many factors, including: • successful development, formulation and cGMP scale-up of drug manufacturing that meets FDA requirements; • successful development of animal models; • successful completion of non-clinical development, including studies in approved animal models; • our ability to pay the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; • successful completion of clinical trials; • receipt of marketing approvals, including the impact of marketing restrictions or required post-approval clinical studies, from the FDA for liquid suspension/pediatric formulations of TPOXX® and similar foreign regulatory authorities; • establishing arrangements on reasonable terms with suppliers and contract manufacturers; • manufacturing stable commercial supplies of drug candidates, including availability of raw materials; • launching commercial sales of the product or new indication/formulation, whether alone or in collaboration with others; and • acceptance of the product or new indication/formulation by potential government customers, public health experts, physicians, patients, healthcare payers and others in the medical community.
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. 26 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. 25 Table of Contents The health security markets in which we compete and will compete are highly competitive.
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; 20 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 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 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. 23 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. 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.
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. 19 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 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.
Failure to obtain regulatory approval of certain indications for TPOXX® may prevent us from fully commercializing TPOXX® in the United States for the mpox indication or may prevent us from getting procurement orders from the U.S.
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.
Competitors may develop products or other technologies that are more effective than any that are being developed by us or may obtain FDA approval for products more rapidly than us.
Competitors may develop products or other technologies that are more effective than TPOXX® or than any products being developed by us, or may obtain FDA approval for products more rapidly than us.
Such actions would hinder our ability to meet contractual obligations and could cause material adverse consequences for our business. 22 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. 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®.
Although TPOXX® is currently stockpiled by certain governments and not sold commercially, in the future we may be required to perform additional clinical trials or change the labeling of TPOXX® if we or others identify side effects after we are on the market, which could harm future sales of such product.
Although TPOXX® is currently stockpiled by certain governments and not sold commercially, in the future we may be required to perform additional clinical trials or change the labeling of TPOXX® if we or others identify side effects after a product is on the market, which could harm future sales of such product.
In addition to owning common stock of the Company, directors and certain executive officers have the right to acquire additional stock through the exercise or conversion of certain securities. 25 Table of Contents A future issuance of preferred stock may adversely affect the rights of the holders of our common stock.
In addition to owning common stock of the Company, directors and certain executive officers have the right to acquire additional stock through the exercise or conversion of certain securities. 24 Table of Contents A future issuance of preferred stock may adversely affect the rights of the holders of our common stock.
TPOXX® is currently identified as a covered countermeasure under the PREP Act declaration issued in October 2008, as amended, which provides us with substantial immunity with respect to the manufacture, administration or use of TPOXX®. Under our BARDA Contract, the U.S.
TPOXX® is currently identified as a covered countermeasure under the PREP Act declaration issued in October 2008, as amended, which provides us with substantial immunity with respect to the manufacture, administration or use of TPOXX®. Under the 19C BARDA Contract, the U.S.
We rely upon the ability, expertise, judgment, discretion, integrity and good faith of our senior management team, including our Chief Executive Officer, Chief Scientific Officer and other key executives. Our success is dependent upon our personnel and our ability to recruit, retain and train high quality employees.
We rely upon the ability, expertise, judgment, discretion, integrity and good faith of our senior management team, including our Chief Executive Officer, Chief Scientific Officer, Chief Financial Officer, and other key employees. Our success is dependent upon our personnel and our ability to recruit, retain and train high quality employees.
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. 18 Table of Contents Our business could be adversely affected by a negative audit by the U.S. Government. U.S.
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.
The development and full commercialization of additional indications of TPOXX® in the U.S., such as the indication of use for post-exposure prophylaxis 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 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.
Our general liability policy provides coverage up to annual aggregate limits of $2 million and coverage of $1 million per occurrence. 27 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. 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.
The health security industry is characterized by rapid and significant technological change. Our success will depend on our ability to develop and apply our technologies in the design and development of our product candidates and to establish and maintain a market for our product candidates.
The health security industry is characterized by rapid and significant technological change. Our success will depend on our ability to develop and apply our technologies in the design and development of our product candidates, to establish and maintain a market for our product candidates, and maintain and grow our market for TPOXX®.
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. 28 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. 27 Table of Contents Item 1B. Unresolved Staff Comments None.
We may not be able to file for or receive necessary regulatory approvals to commercialize our products in additional new markets, in which case, our target market may be reduced and our ability to realize the full market potential of our product candidates may be harmed and our business, financial condition, results of operations and prospects may be adversely affected.
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.
As such, the Company is continually coordinating with service providers and vendors, in particular Contract Manufacturing Organizations that constitute our supply chain, with respect to risks and mitigating actions.
As such, the Company is continually coordinating with service providers and vendors, in particular third party contract manufacturing organizations that constitute our supply chain, with respect to risks and mitigating actions.
We have received FDA approval for the oral and intravenous formulations of TPOXX® in the U.S., not the liquid suspension/pediatric formulation, or any other indication beyond treatment for smallpox, for TPOXX®.
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.
Changes in the perception of the risk that military personnel or civilians could be exposed to biological agents as weapons of bioterrorism or biowarfare may delay or cause resistance to bringing investigational products to market or limit pricing or purchases of approved products, any of which could materially harm our business.
Presidential administration, as well as changes in the perception of the risk that military personnel or civilians could be exposed to biological agents as weapons of bioterrorism or biowarfare may delay or cause resistance to bringing investigational products to market or limit pricing or purchases of approved products, any of which could materially harm our business.
Lawsuits, protests or other negative publicity may adversely affect the degree of market acceptance of, and thereby limit the demand for, TPOXX® and our biodefense product candidates.
Lawsuits, protests or other negative publicity may adversely affect the degree of market acceptance of, and thereby limit the demand for, TPOXX® and any biodefense product candidates.
Changing political or social factors and opposition, such as protests and potential related litigation, may delay or impair our ability to market TPOXX® and any other biodefense product candidates and may require us to spend time and money to address these issues.
Risks Related to Commercial and International Activities Changing political or social factors and opposition, such as protests and potential related litigation, may delay or impair our ability to market TPOXX® and any other biodefense product candidates and may require us to spend time and money to address these issues.
The IRA also requires manufacturers of certain Part B and Part D drugs to issue to HHS rebates based on certain calculations and triggers (i.e., when drug prices increase and outpace the rate of inflation). Implementation of the IRA's drug price negotiation provisions began in 2023, and will continue to be implemented over the next several years.
The IRA also requires manufacturers of certain Part B and Part D drugs to issue to HHS rebates based on certain calculations and triggers (i.e., when drug prices increase and outpace the rate of inflation). Implementation of the IRA's drug price negotiation provisions began in 2023, and is expected to continue over the next several years.
Government for the post-exposure prophylaxis indication and may impact other regulatory authorities' future review of other indications of TPOXX®, which in turn, could adversely impact commercializing TPOXX® in other countries, and such delays or required alterations to regulatory applications could also have a material adverse effect on future revenue opportunities for the Company.
Government for the post-exposure prophylaxis indication and may impact other regulatory authorities' future review of other indications of TPOXX®, which in turn, could adversely impact potential sales of TPOXX® in other countries, and such delays or required alterations to regulatory applications could also have a material adverse effect on our future revenue opportunities.
Additionally, we rely on third-party providers for storing, packaging and delivering certain of our products, including a portion of the stockpile of IV TPOXX® under the 19C BARDA Contract, thereby entrusting such vendor or vendors with the care and handling of a substantial portion of IV TPOXX® inventory.
Additionally, we rely on third-party providers for storing, packaging and delivering certain of our products, including a portion of the stockpile of IV TPOXX® purchased by government under the 19C BARDA Contract that we manage, thereby entrusting such vendor or vendors with the care and handling of a substantial portion of IV TPOXX® inventory.
Manufacturing API and finished drug products, especially in large quantities, is complex. Our products require several manufacturing steps at multiple facilities, and may involve complex techniques to assure quality and sufficient quantity, especially as the manufacturing scale increases. Our products must be made consistently and in compliance with a clearly defined manufacturing process.
Manufacturing API and finished drug products, especially in large quantities, is complex. Our products require several manufacturing steps at multiple facilities and involve complex techniques to assure quality and sufficient quantity. Our products must be made consistently and in compliance with a clearly defined manufacturing process.
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; 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 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.
While the Company has not identified or been notified by government customers of impediments to the continued full performance of their government contracts in connection with the COVID-19 pandemic, future global infectious disease outbreaks or climate-related matters could have material adverse impact on the financial condition of the Company and its long-term operating performance.
While the Company has not identified or been notified by government customers of impediments to the continued full performance of their government contracts, future global infectious disease outbreaks or climate-related matters could have material adverse impact on the financial condition of the Company and its long-term operating performance.
Government procurement contract are significantly different from expectations, or if operating expenses or other expenses meaningfully exceed our expectations or cannot be adjusted accordingly, then our business, financial condition, results of operations and prospects could be materially adversely affected. 21 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 our business would suffer.
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.
Because pharmaceutical manufacturers are only permitted to commercialize indications and formulations that have received FDA approval (or in other jurisdictions according to their applicable regulatory and legal frameworks), any regulatory or legal setbacks as described above could have an adverse impact on the Company’s ability to sell other formulations or for other uses of TPOXX® pending such approvals.
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.
While we believe our current cash position is strong, our ability to continue to fund future operations will be substantially impacted by cash flows from the 19C BARDA Contract or any new procurement contract with the U.S. Government, which may not be sufficient if the U.S.
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.
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. A substantial percentage of our potential revenues come from government contracts.
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.
Government should indemnify us against claims by third parties for death, personal injury and other damages related to TPOXX®, including reasonable litigation and settlement costs, to the extent that the claim or loss results from specified risks not covered by insurance or caused by our grossly negligent or criminal behavior.
Government should indemnify us against claims by third parties for death, personal injury and other damages related to TPOXX®, including reasonable litigation and settlement costs, to the extent that the claim or loss results from specified risks not covered by insurance or caused by our grossly negligent or criminal behavior. There is no assurance that any future U.S.
As of February 15, 2024, directors, executive officers and principal stockholders (excluding institutional and retail investors) beneficially owned approximately 35% of our outstanding common stock.
As of February 14, 2025, directors, executive officers and principal stockholders (excluding institutional and retail investors) beneficially owned approximately 35% of our outstanding common stock.
Government of any other biodefense product candidates that we may successfully develop. 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.
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.
Our failure to anticipate significant technical problems, estimate costs accurately or control costs during performance of a fixed-price contract could reduce the profitability of such contract, or if severe, cause a loss, which could in turn negatively affect our operating results.
Our failure to secure financial terms, including price, generally consistent with our prior agreements, anticipate significant technical problems, estimate costs accurately or control costs during performance of a fixed-price contract could reduce the profitability of such contract, or if severe, cause a loss, which could in turn negatively affect our operating results.
Regulatory approval by the FDA, which we obtained for oral TPOXX®, or by a foreign regulatory authority such as Health Canada and the European Medicines Agency, which we obtained for oral TPOXX®, does not ensure approval by future additional regulatory authorities in other foreign countries or jurisdictions or by the FDA for expanded indications or new formulations.
Regulatory 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.
Foreign Corrupt Practices Act (FCPA) and many other global anti-corruption laws, may hold the Company liable for the actions of our third-party partners.
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.
The funding of government programs, which fund BARDA’s purchases under the 19C BARDA Contract, is subject to Congressional appropriations, generally made on a fiscal year basis even though a program may continue for several years.
The funding of government programs, which fund BARDA’s purchases under the 19C BARDA Contract and are expected to fund any new contract to supply TPOXX® to the U.S. Government, is subject to Congressional appropriations, generally made on a fiscal year basis even though a program may continue for several years.
Before obtaining regulatory approval for the sale of our drug candidates, extensive development is required. The goal of development is to use clinical studies to demonstrate the safety of our drug candidates and animal trials to demonstrate the efficacy of our drug candidates.
Before obtaining regulatory approval for the sale of our drug candidates, extensive development is required. The development of a smallpox treatment candidate requires clinical trials to demonstrate safety and animal studies to demonstrate efficacy.
We must continue to recruit, retain and motivate management and other employees sufficient to maintain our current business and support our projected growth. The loss of services of any members of our key management team could have a material adverse effect on our business. The COVID-19 pandemic increased employment changes in many industries, including ours.
We must continue to recruit, retain and motivate management and other employees sufficient to maintain our current business and support our projected growth. The loss of services of any members of our key management team could have a material adverse effect on our business.
If a third-party provider fails to comply with applicable laws and regulations, fails to meet expected deadlines, fails to conduct trials in accordance with regulatory requirements or our stated protocols, experiences shortages or delays, or otherwise does not carry out its contractual duties to us, or encounters physical damage or natural disaster or disruptions at its facilities, our ability to meet our obligations under any contract including the 19C BARDA Contract or to develop, obtain approval of and commercialization of other indications of TPOXX® or other drug candidates, could be significantly impaired or delayed.
If a third-party provider fails to comply with applicable laws and regulations, fails to meet expected deadlines, fails to conduct trials in accordance with regulatory requirements or our stated protocols, experiences shortages or delays, or otherwise does not carry out its contractual duties to us, or encounters physical damage or natural disaster or disruptions at its facilities, our ability to meet our obligations under any contract including the 19C BARDA Contract or any future U.S.
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, 2023, most of the remaining contract value of the 19C BARDA Contract is tied to options exercisable in the sole discretion of BARDA.
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.
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.
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.
Generally, government contracts contain provisions permitting unilateral termination or modification, in whole or in part, at the government’s convenience. Under general principles of government contracting law, if the government terminates a contract or grant for convenience, the terminated company may recover only its incurred or committed costs, settlement expenses and profit on work completed prior to the termination.
Under general principles of government contracting law, if the government terminates a contract or grant for convenience, the terminated company may recover only its incurred or committed costs, settlement expenses and profit on work completed prior to the termination.
As a result, we rely on Meridian’s ability to collect and remit payment to us in a timely manner. Meridian could fail to perform such obligations adequately, cease operations abruptly or become insolvent, or our relationships with Meridian may otherwise change adversely. Any of the foregoing could adversely impact our business, financial condition and operating results as a result.
Meridian could fail to perform such obligations adequately, cease operations abruptly or become insolvent, or our relationships with Meridian may otherwise change adversely. Any of the foregoing could adversely impact our business, financial condition and operating results as a result.
The collection process under the PREP Act can be lengthy and complicated, and there is no guarantee that we would be able to recover these amounts from the U.S. Government.
Government contracts will include a comparable indemnification provision. In addition, the collection process under the PREP Act can be lengthy and complicated, and there is no guarantee that we would be able to recover these indemnifiable amounts from the U.S. Government.
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.
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.
Among the most significant government contracting regulations that affect our business are: • the Federal Acquisition Regulation and other agency-specific regulations supplemental to the Federal Acquisition Regulation, which comprehensively regulate the procurement, formation, administration and performance of U.S. government contracts; 17 Table of Contents • the business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act and the Foreign Corrupt Practices Act ("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; 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.
The value of goods and services subject to options may constitute the majority of the total value of the underlying contract, as in the case of the 19C BARDA Contract.
The value of goods and services subject to options may constitute the majority of the total value of the underlying contract, as in the case of the 19C BARDA Contract as well as any new contract to continue supplying TPOXX® to the U.S. Government.
The Healthcare Reform Act and other healthcare reform measures that may be adopted in the future could have an adverse effect on our industry generally, as well as potential future sales and profitability of our current or future products.
The Healthcare Reform Act and other healthcare reform measures that may be adopted in the future could have an adverse effect on our industry generally, as well as potential future sales and profitability of our current or future products. Additionally, the new U.S. administration may propose or mandate policy changes that create additional uncertainty for our business.
As of January 17, 2024, the TPOXX® patent portfolio has seven patent families consisting of 30 U.S. utility patents, 109 issued foreign patents, two U.S. utility patent applications, and 16 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 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.
If we commence commercial sales of products, we still must compete in the manufacturing and marketing of such products, areas in which it is very difficult to succeed and in which we have limited experience and in which we are partially dependent on third parties.
Following product approval and commercial launch, such as for TPOXX®, we still must compete in the manufacturing and marketing of such products, areas in which it is very difficult to succeed and in which we are partially dependent on third parties.
Reduced or discontinued BARDA funding, or the non-exercise of contract options under the 19C BARDA Contract, could cause our business, financial condition, results of operations and prospects to suffer materially. Government-funded contracts often consist of standalone procurement orders or a base period of performance and options for the performance of certain future activities.
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.
Pursuant to the International Promotion Agreement described under “Business,” we granted a third party, Meridian Medical Technologies ("Meridian") exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in all geographic regions except for the United States (the “Territory”), and Meridian agreed not to commercialize any competing product, as defined in the International Promotion Agreement, in the specified field of use in the Territory.
Pursuant to the International Promotion Agreement described under “Business,” we previously granted a third party, Meridian Medical Technologies ("Meridian") exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in all geographic regions except for the United States (the “Territory”). In June 2024, we reacquired international promotional rights from Meridian.
If some of these options are not exercised, because levels of government expenditures and authorizations for biodefense decrease or shift to other programs, or for any other reason, our business, financial condition, results of operations and prospects may suffer materially.
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.
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. Government stockpile of TPOXX® could have a material adverse effect on our long-term business, financial condition, results of operations and prospects.
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.
If we do not renew the International Promotion Agreement, 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.
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.
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. 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.
In the United States market, we have retained all sales and marketing rights with respect to oral TPOXX®. In this market, 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.
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.
The Company is reliant on Meridian to collect payments from international customers, and to remit the Company ’ s share of such payment to the Company. Under the terms of the International Promotion Agreement, Meridian is responsible for collecting payments from customers and remitting such payments to us on a quarterly basis.
Under the terms of the Amended International Promotion Agreement, Meridian remains responsible for collecting payments from customers under certain legacy contracts and remitting such payments to us on a quarterly basis. As a result, we rely on Meridian’s ability to collect and remit payment to us in a timely manner.
The majority of potential revenue under the 19C BARDA Contract, the Company's largest procurement contract, is tied to options which 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 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.
We have incurred in the past, and could incur net losses in the future, including if options are not exercised under the 19C BARDA Contract.
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.
Government, export control, government security regulations, employment practices, protection of the environment, accuracy of records and the recording and reporting of costs, and foreign corrupt practices.
These laws and rules include those related to procurement integrity, rates and pricing of services and goods to be reimbursed by the U.S. Government, export control, government security regulations, employment practices, protection of the environment, accuracy of records and the recording and reporting of costs, and foreign corrupt practices.
Multiple pharmaceutical manufacturers have challenged the law in court, largely on constitutional grounds. These suits will continue through 2024 and the ultimate effects of such legal challenges are unclear. At this time, we continue to evaluate the effect of the IRA on our business operations and financial condition and results as the full impact of the IRA remains uncertain.
At this time, we continue to evaluate the effect of the IRA on our business operations and financial condition and results as the full impact of the IRA remains uncertain.
We currently have product liability insurance with coverage up to a $10 million annual aggregate limit and a $10 million per occurrence limit. Product liability insurance is difficult to obtain and increasingly expensive.
We currently have product liability insurance with coverage we believe is adequate to protect against potential product liability claims. Product liability insurance is difficult to obtain and increasingly expensive.
Government, international governments, and any future business with state and local governmental agencies are subject to specific procurement regulations and a variety of other legal and compliance obligations. These laws and rules include those related to procurement integrity, rates and pricing of services and goods to be reimbursed by the U.S.
Laws and regulations affecting government contracts and grants might make it more costly and difficult for us to successfully conduct our business. Our business with the U.S. Government, international governments, and any future business with state and local governmental agencies is subject to specific procurement regulations and a variety of other legal and compliance obligations.
Diem Nguyen commenced her term as Chief Executive Officer. As a general matter, the transition could result in uncertainty or disruption to our business, which could adversely impact our business and results of operations. Our business and operations would suffer in the event of a significant computer system failure, cyber-attack or deficiency in our cyber-security.
Our business and operations would suffer in the event of a significant computer system failure, cyber-attack or deficiency in our cyber-security.
Additionally, the 19C BARDA Contract does not necessarily increase the likelihood that we will secure future comparable contracts with the U.S. Government. Laws and regulations affecting government contracts and grants might make it more costly and difficult for us to successfully conduct our business. Our business with the U.S.
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.
There is no guarantee that any of the remaining options will be exercised, or if they are exercised when such exercise of options will occur.
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.
We cannot predict the ultimate impact such events might have on the Company’s business, financial condition and results of operations. Our current international revenues depend heavily on the success of the efforts of Meridian pursuant to an International Promotion Agreement.
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..
Risks Related to Commercial and International Activities We cannot predict whether or when we will be permitted to commercialize TPOXX® in the U.S. 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.
Government elects, in its sole discretion, not to exercise or to significantly delay exercise of some or all of the remaining options under the 19C BARDA Contract or any new procurement contracts. If cash flows from a U.S.
If BARDA fails to exercise the remaining option under the 19C BARDA Contract or we fail to enter into a new U.S.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeCybersecurity threats, including those resulting from any previous cybersecurity incidents, have not materially affected our Company, including our business strategy, results of operations, or financial condition. We do not believe that cybersecurity threats resulting from any previous cybersecurity incidents of which we are aware are reasonably likely to materially affect our Company.
Biggest changeTo date, risks from cybersecurity threats, including those resulting from any previous cybersecurity incidents, have not materially affected our Company, including our business strategy, results of operations, or financial condition. We do not believe that cybersecurity threats resulting from any previous cybersecurity incidents of which we are aware are reasonably likely to materially affect our Company.
Our Chief Information Officer has over a decade of experience leading cybersecurity oversight, and others on our IT security team have cybersecurity experience or certifications. We view cybersecurity as a shared responsibility, and we periodically perform simulations and tabletop exercises at a management level and engage external resources and advisors as needed.
Our Chief Information Officer has over a decade of experience leading cybersecurity oversight, and others on our IT security team have cybersecurity experience and certifications. We view cybersecurity as a shared responsibility, and we periodically perform simulations and tabletop exercises at a management level and engage external resources and advisors as needed.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeRelated Party Transactions, to the consolidated financial statements. In Corvallis, we lease approximately 10,276 square feet. Until its expiration on December 31, 2017, this facility was leased under an amended lease agreement signed in January 2007, and most recently changed through an addendum in April 2015.
Biggest changeIn Corvallis, we lease approximately 10,276 square feet. Until its expiration on December 31, 2017, this facility was leased under an amended lease agreement signed in January 2007, and most recently changed through an addendum in April 2015. On November 3, 2017 we entered into a new lease for the same space which was scheduled to expire in December 2019.
Item 2. Properties Our headquarters are located in New York, NY, and our research and development facilities are located in Corvallis, Oregon. In May 2017, we entered into a new 10-year lease with a related party to let 3,200 square feet in New York, NY to serve as our corporate headquarters. For more information about the lease, see Note 13.
Item 2. Properties Our offices are located in New York, NY, and Corvallis, Oregon. In May 2017, we entered into a new 10-year lease with a related party to let 3,200 square feet in New York, NY to serve as our corporate headquarters. For more information about the lease, see Note 13. Related Party Transactions, to the consolidated financial statements.
In the second quarter of 2021, we exercised the second renewal option, which extended the lease expiration date to December 31, 2024.
In the second quarter of 2019, we exercised the first renewal option which was scheduled to expire in December 2021. In the second quarter of 2021, we exercised the second renewal option, which extended the lease expiration date to December 31, 2024.
Removed
On November 3, 2017 we entered into a new lease for the same space which was scheduled to expire in December 2019. In the second quarter of 2019, we exercised the first renewal option which was scheduled to expire in December 2021.
Added
In the second quarter of 2024, we entered into an additional addendum, which extended the lease expiration date to December 31, 2026.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeOn December 31, 2023, the remaining repurchase authorization for approximately $21 million expired. 30 Table of Contents Performance Graph The following line graph compares the cumulative total stockholder return through December 31, 2023, assuming reinvestment of dividends, by an investor who invested $100 on December 31, 2018 in each of (i) our common stock; (ii) the Nasdaq Composite; and (iii) the Nasdaq Biotech Composite. 2018 2019 2020 2021 2022 2023 SIGA Technologies, Inc. $ 100 $ 60 $ 92 $ 95 $ 99 $ 81 NASDAQ Composite Index $ 100 $ 135 $ 194 $ 236 $ 158 $ 226 NASDAQ Biotech Composite Index $ 100 $ 124 $ 156 $ 155 $ 138 $ 144 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.” 31 Table of Contents
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
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 40 holders of record as of February 15, 2024.
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.
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 May 4, 2023, the Board declared a special dividend of $0.45 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 March 12, 2024, the Board declared a special dividend of $0.60 per share on the common stock of the Company.
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 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.
Removed
The special dividend was paid on June 1, 2023 to shareholders of record at the close of business on May 16, 2023.
Added
The Company did not repurchase any equity securities during the fourth quarter ended December 31, 2024.
Removed
On March 12, 2024, the Board declared a special dividend of $0.60 per share on the common stock of the Company, payable on April 11, 2024 to shareholders of record at the close of business on March 26, 2024.
Removed
Issuer Purchases of Equity Securities Period Total Number of Shares Purchased Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Programs Dollar Value of Shares That May Yet Be Purchased Under the Programs October 1, 2023 to October 31, 2023 - $ - - $ 21,498,370 November 1, 2023 to November 30, 2023 - - - 21,498,370 December 1, 2023 to December 31, 2023 - - - 21,498,370 Total - $ - - On August 5, 2021, the Company announced that the Board of Directors authorized a share repurchase program under which the Company may repurchase up to $50 million of the Company's common stock through December 31, 2023.
Removed
The Company started repurchasing shares under this program in the fourth quarter of 2021.
Removed
The timing and actual number of shares repurchased under any authorization of this type depends on a variety of factors, including: the timing of exercise of procurement options under government contracts; alternative opportunities for strategic uses of cash; the stock price of the Company’s common stock; market conditions; and other corporate liquidity requirements and priorities.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

50 edited+23 added−36 removed24 unchanged
Biggest changeAs of December 31, 2023, the Company has cumulatively delivered $323.0 million of oral TPOXX® to the Strategic Stockpile, of which $97.9 million was delivered in the fourth quarter of 2023; has cumulatively received $20.5 million for the completed manufacture of IV BDS, of which $20.5 million has been recorded as deferred revenue as of December 31, 2023; and has been cumulatively reimbursed $7.9 million in connection with post-marketing activities for oral and IV TPOXX®.
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®.
In connection with the 2022 global response to an 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.
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.
Our accounts receivable balance as of December 31, 2023 primarily reflects 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, 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.
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®, 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 for a pediatric formulation, and procurement activities.
As of December 31, 2023, the Company invoiced the full amount of available funding. As of December 31, 2023, there is no remaining revenue to be recognized in the future under the PEP Label Expansion R&D Contract.
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.
Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (filed with the SEC on March 2, 2023) for additional discussion of our financial condition and results of operations for the year ended December 31, 2022, as well as our financial condition and results of operations for the year ended December 31, 2022 compared to the year ended December 31, 2021.
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.
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), 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), shortfalls on stock-based compensation, and state and local taxes.
In connection with a potential FDA label expansion of oral TPOXX® for an indication covering smallpox post-exposure prophylaxis (“PEP”), the Company completed an immunogenicity trial and an expanded safety trial in early 2023.
In connection with a potential FDA label expansion of oral TPOXX® for an indication covering smallpox post-exposure prophylaxis (“PEP”), the Company has completed an immunogenicity trial and an expanded safety trial.
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. 38 Table of Contents Results of Operations for the Years ended December 31, 2023 and 2022 Revenues from product sales and supportive services for the years ended December 31, 2023 and 2022 were $130.7 million and $86.7 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. 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.
Liquidity and Capital Resources As of December 31, 2023, we had $150.1 million in cash and cash equivalents, compared with $98.8 million at December 31, 2022. 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, 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.
As of December 31, 2023, 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, $4.3 million for the delivery of IV FDP to the Strategic Stockpile and $22.1 million for other base period activities.
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.
If BARDA decides to only 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.
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.
As of December 31, 2023, 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 $407.1 million of payments are related to exercised options and up to approximately $143.7 million of payments are currently specified as unexercised options.
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.
There are exercised options for the following activities: payments up to $337.7 million for the manufacture and delivery of up to 1.1 million courses of oral TPOXX®; payments up to $51.2 million for the manufacture of courses of IV FDP, of which $20.4 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, 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®.
We include estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur and when any uncertainty associated with variable consideration is resolved.
We estimate variable consideration as the most likely amount to which we expect to be entitled. We include estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur and when any uncertainty associated with variable consideration is resolved.
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%. Under the terms of this contract, exercise of procurement options is at the sole discretion of BARDA.
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.
For the year ended December 31, 2022, we recognized a tax provision of $10.2 million on pre-tax income of $44.1 million. Our effective tax rate for the year ended December 31, 2022 was 23.2% 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.
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.
The Health Canada approved label indication covers the treatment of smallpox. With respect to the regulatory approvals by the EMA, MHRA and Health Canada, oral tecovirimat represents the same formulation that was approved by the FDA in July 2018 under the brand name TPOXX®.
With respect to the regulatory approvals by the EMA, PMDA, MHRA and Health Canada, oral tecovirimat represents the same formulation approved by the FDA in July 2018 under the brand name TPOXX®.
The remaining amounts of the receivable balance are expected to be collected during the first or second quarter of 2024. Our accounts receivable balance as of December 31, 2022 primarily reflected sales of oral TPOXX® to various international countries, of which approximately $35 million was received by the Company in February 2023.
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.
Such revenues for the year ended December 31, 2022 include $71.0 million related to international sales of oral TPOXX®; $7.5 million of oral TPOXX® sales to the DoD; and approximately $7.2 million of sales of IV TPOXX® to the U.S. Government under the 19C BARDA Contract.
Such revenues for the year ended December 31, 2024 include $73.9 million of oral TPOXX® sales and $26.2 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA Contract; $23.0 million related to international sales of oral TPOXX®; and approximately $10.1 million of oral TPOXX® sales to the DoD.
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.
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.
Our performance obligations are satisfied over time as work progresses or at a point in 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 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 research and development are recognized over time. 36 Table of Contents Due to the nature of the work required to be performed on many of our performance obligations for which revenue is recognized over time, the estimation of total revenue and costs to satisfy the obligations may be complex, subject to many variables and requires significant judgment.
Due to the nature of the work required to be performed on many of our performance obligations for which revenue is recognized over time, the estimation of total revenue and costs to satisfy the obligations may be complex, subject to many variables and requires significant judgment. The consideration associated with these types of performance obligations is considered variable.
Critical Accounting Estimates 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.
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.
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. As such, the Company may not be eligible to receive all available funds.
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.
There are options for the following activities: payments of up to $112.5 million for the delivery of oral TPOXX® to the Strategic Stockpile; and 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. 34 Table of Contents The options related to IV TPOXX® are divided into two primary manufacturing steps.
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.
In addition to historical information, the following discussion and other parts of this Annual Report contain forward-looking information that involves risks and uncertainties. Overview SIGA Technologies, Inc. (“SIGA” or the “Company”) is a commercial-stage pharmaceutical company. The Company sells its lead product, TPOXX® (“oral TPOXX®,” also known as "tecovirimat" in certain international markets), to the U.S.
In addition to historical information, the following discussion and other parts of this Annual Report contain forward-looking information that involves risks and uncertainties. Overview SIGA Technologies, Inc. (“SIGA” or the “Company”) is a commercial-stage pharmaceutical company.
The remaining $0.3 million of deferred revenue will be recognized as IV FDP containing such IV BDS is delivered to and accepted by the Strategic Stockpile. The options that have been exercised to date provide for payments up to approximately $407.1 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, 2024, provide for payments up to approximately $519.6 million.
Revenues from research and development activities for the years ended December 31, 2023 and 2022, were $9.2 million and $24.1 million, respectively. These revenues are mostly earned in connection with performance of research and development activities under the PEP Label Expansion R&D Contract and 19C BARDA Contract.
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.
The decrease of $14.9 million of revenue is primarily related to a decrease in clinical trial activity. Cost of sales and supportive services for the years ended December 31, 2023 and 2022 were $17.8 million and $10.4 million, respectively. Such costs in 2023 were primarily associated with increases in the manufacture and delivery of oral TPOXX® courses to the U.S.
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.
In the first two months of 2024 ended February 29, 2024, approximately $15 million of oral TPOXX® was delivered to the Strategic Stockpile. Unexercised options specify potential payments up to approximately $143.7 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 $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.
The fee Meridian retains pursuant to the International Promotion Agreement is a specified percentage of the collected proceeds of sales of oral TPOXX®, net of certain expenses, for calendar years in which customer collected amounts net of such expenses are less than or equal to a specified threshold, and a higher specified percentage of such collected net proceeds for calendar years in which such net collected amounts exceed the specified threshold.
Sales to international customers pursuant to the Pre-amendment International Promotion Agreement were invoiced and collected by Meridian, and such collections were remitted, less Meridian's fees, to the Company under a quarterly process specified in the Pre-amendment International Promotion Agreement; and Meridian was entitled to a specified percentage of the collected proceeds of sales of oral TPOXX®, net of certain expenses, for calendar years in which customer collected amounts net of such expenses were less than or equal to a specified threshold, and to a higher specified percentage of such collected net proceeds for calendar years in which such net collected amounts exceeded the specified threshold.
The contract with the CDND (the "Canadian Military Contract"), issued in April of 2020 and subsequently amended, is option-based and initially specified that the CDND would purchase up to $14 million of oral TPOXX® if all options were exercised. 35 Table of Contents International Promotion Agreement Under the terms of the International Promotion Agreement, as amended, which has an initial term that expires on May 31, 2024, Meridian was granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States (the “Territory”), and Meridian has agreed not to commercialize any competing product, as defined in the International Promotion Agreement, in the specified field of use in the Territory.
Under the terms of the original International Promotion Agreement ("Pre-amendment International Promotion Agreement"), which had an initial term that expired on May 31, 2024, Meridian had been granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States (the “Territory”), and Meridian agreed not to commercialize any competing product, as defined in the Pre-amendment International Promotion Agreement, in the specified field of use in the Territory.
For the year ended December 31, 2022, we paid a special dividend of approximately $32.9 million. In addition, we purchased approximately 1.8 million shares of common stock for approximately $13.0 million. Future Cash Requirements As of December 31, 2023, we have outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $14.8 million.
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
The remaining amounts of the receivable balance were collected during the second quarter of 2023. Investing Activities We used $21,686 for capital expenditures for the year ended December 31, 2023. For the year ended December 31, 2022, there were no cash-related activities.
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.
On July 13, 2018, the United States Food & Drug Administration (“FDA”) approved oral TPOXX® for the treatment of smallpox. The Company has been delivering oral TPOXX® to the U.S. Strategic National Stockpile ("Strategic Stockpile") since 2013. In connection with IV TPOXX®, SIGA announced on May 19, 2022 that the FDA approved this formulation for the treatment of smallpox.
TPOXX® is an antiviral drug for the treatment of human smallpox disease caused by variola virus. On July 13, 2018, the United States Food & Drug Administration (“FDA”) approved oral TPOXX® for the treatment of smallpox. The Company has been delivering oral TPOXX® to the U.S. Strategic National Stockpile ("Strategic Stockpile") since 2013.
SIGA retains ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retains sales and marketing rights with respect to oral TPOXX®. SIGA’s consent is required for the entry into any sales arrangement pursuant to the International Promotion Agreement.
Under the Pre-amendment International Promotion Agreement, as well as the current International Promotion Agreement, SIGA has always retained ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retained sales and marketing rights with respect to oral TPOXX®.
The nature and timing of a 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 the trials; the Company is currently targeting a Supplemental NDA filing in 2024.
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.
Some of our accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. Our most critical accounting estimates include revenue recognition over time, and income taxes (including realization of deferred tax assets).
Some of our accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. Our most critical accounting estimate is revenue recognition over time. Revenue Recognition We account for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”).
Revenue Recognition We account for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). The unit of account in ASC 606 is a performance obligation. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied.
The unit of account in ASC 606 is a performance obligation. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. Our performance obligations are satisfied over time as work progresses or at a point in time.
In addition to being approved by the FDA, oral TPOXX® (tecovirimat) has regulatory approval with the European Medicines Agency ("EMA"), Health Canada and the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom. The EMA and MHRA approved label indication covers the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against 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 most recently, in December 2024, the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA").
Research and development expenses were $16.4 million for the year ended December 31, 2023, a decrease of approximately $6.1 million from the $22.5 million incurred during the year ended December 31, 2022.
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.
A significant change in one or more of these estimates could affect the profitability of one or more of our performance obligations. Income Taxes Our income tax expense and deferred tax assets and liabilities reflect management’s best estimate of current and future taxes to be paid.
A significant change in one or more of these estimates could affect the profitability of one or more of our performance obligations.
Government and various international countries. Such costs in 2022 were primarily associated with the manufacture and delivery of oral TPOXX® courses to various international countries and approximately $4.4 million of costs for the manufacture and delivery of IV TPOXX®. Selling, general and administrative expenses for the years ended December 31, 2023 and 2022 were $22.0 million and $35.1 million, respectively.
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.
Net cash provided by operations for the years ended December 31, 2023 and 2022 was $94.8 million and $41.6 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.
As of December 31, 2023, there were five randomized, placebo-controlled clinical trials enrolling patients, when available, in locations including the United States, United Kingdom, the Democratic Republic of Congo ("DRC"), South America and Europe. These randomized clinical trials are enrolling patients 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 is to seek to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease.
Financing Activities Cash used in financing activities for the years ended December 31, 2023 and 2022 was $43.4 million and $46.0 million, respectively. For the year ended December 31, 2023, we paid a special dividend of approximately $32.1 million. In addition, we purchased approximately 1.7 million shares of common stock for approximately $11.0 million.
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.
The increase relates to interest income earned on cash and cash equivalents at rates that are substantially higher in 2023 in comparison to 2022. For the year ended December 31, 2023, we recognized a tax provision of $19.7 million on pre-tax income of $87.8 million.
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.
U.S. Department of Defense Procurement Contracts On May 12, 2022, the Company announced a contract with the U.S. Department of Defense ("DoD") for the procurement of oral TPOXX® ("DoD Contract #1").
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®.
Government and international governments (including government affiliated entities). Additionally, the Company sells the intravenous formulation of TPOXX® ("IV TPOXX®") to the U.S. Government. TPOXX® is an oral formulation antiviral drug for the treatment of human smallpox disease caused by variola virus.
The Company sells its lead product, TPOXX® (“oral TPOXX®,” also known as "tecovirimat," "Tecovirimat SIGA," or "TEPOXX (tecovirimat)" in certain international markets), to the U.S. Government and international governments (including government affiliated entities). In certain international markets, the Company may sell TPOXX® through a distributor. Additionally, the Company sells the intravenous formulation of TPOXX® ("IV TPOXX®") to the U.S. Government.
Removed
The Company may be able to use data from the trials noted above, as well as from other trials, to potentially pursue an FDA label expansion of oral TPOXX® for an indication covering the treatment of mpox.
Added
On May 18, 2022 the FDA approved IV TPOXX® for the treatment of smallpox.
Removed
The viability, and timing, of a potential FDA submission for an mpox indication will be impacted by a series of factors, including the magnitude and severity of future mpox cases, the location of future cases, enrollment in clinical trials, and results of randomized, placebo-controlled and observational clinical trials. Recent Developments ● On January 27, 2024, Dr.
Added
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.
Removed
Diem Nguyen commenced her employment as our new Chief Executive Officer and was appointed to the Board. ● During January and February of 2024, the Company delivered a total of approximately $7 million of oral TPOXX® to six countries in Europe pursuant to the $18 million firm commitment order announced in October 2023, as well as a total of approximately $15 million of oral TPOXX® to the U.S.
Added
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.
Removed
Strategic National Stockpile. ● On March 12, 2024, the Board declared a special dividend of $0.60 per share on the common stock of the Company. The special dividend is payable on April 11, 2024 to shareholders of record at the close of business on March 26, 2024. 33 Table of Contents Procurement Contracts with the U.S.
Added
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.
Removed
The request for proposal that preceded the award of the 19C BARDA Contract indicated that the expected purpose of the contract was to maintain the level of smallpox antiviral preparedness in the Strategic Stockpile.
Added
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.
Removed
Based on prior product delivery activity, and current FDA-approved shelf life of oral TPOXX®, the Company estimates that the remaining options under the 19C BARDA Contract for 363,000 courses of oral TPOXX® (value of $112.5 million) and 32,000 courses of IV FDP (value of $25.6 million) would need to be exercised in 2024 in order to approximately maintain historical stockpile levels of unexpired TPOXX® treatment in the Strategic Stockpile.
Added
Meridian has limited, non-exclusive rights to advertise, promote, offer for sale and sell oral TPOXX® in the European Economic Area, Australia, Japan, Switzerland, the United Kingdom and the Association of Southeast Asian Nations and its member states (collectively, the “Current Territory”).
Removed
The DoD Contract #1 included a firm commitment for the DoD to procure approximately $3.6 million of oral TPOXX®, and an option, exercisable at the sole discretion of the DoD, for the procurement of an additional approximately $3.8 million of oral TPOXX®.
Added
Meridian also performs non-promotional activities under specified contracts with third parties entered into prior to June 1, 2024, that provide for the sale of oral TPOXX® in the Current Territory.
Removed
In the second quarter of 2022, the Company delivered oral TPOXX® to the DoD and recognized revenue of $3.6 million, fulfilling the firm commitment in DoD Contract #1.
Added
The International Promotion Agreement entitles Meridian to receive a fee equal to a high single digit percentage of collected proceeds (whether collected by Meridian or the Company), net of certain expenses, of sales of oral TPOXX® in the Current Territory in the field of use specified in the International Promotion Agreement.
Removed
In the third quarter of 2022, the DoD exercised the option for $3.8 million of oral TPOXX® and the Company satisfied its obligation by delivering product in September 2022 and recognized the related revenue. On September 28, 2022, the Company and the DoD signed a new procurement contract ("DoD Contract #2").
Added
The International Promotion Agreement has a fixed term that expires on May 31, 2026, with no automatic renewal.
Removed
The DoD Contract #2 included a firm commitment for the DoD to procure approximately $5.1 million of oral TPOXX®, and an option, exercisable at the sole discretion of the DoD for the procurement of an additional approximately $5.5 million of oral TPOXX®.
Added
SIGA’s consent is required prior to the entry by Meridian into any sales arrangement pursuant to the International Promotion Agreement.
Removed
In March 2023, the Company fulfilled the firm commitment by delivering $5.1 million of oral TPOXX® to the DoD, and recognized the related revenue. Additionally, in March 2023 the DoD exercised the $5.5 million option in DoD Contract #2 for the procurement of oral TPOXX® and the Company delivered these courses to the DoD in the fourth quarter of 2023.
Added
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.
Removed
In February 2024, DoD Contract #2 was amended and approximately $1 million of oral TPOXX® was ordered by the DoD. International Procurement Contracts In 2023, the Company has delivered, and received acceptance for, approximately $21.3 million of oral TPOXX® to five European countries, one Middle Eastern country, and one Asia Pacific country.
Added
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.
Removed
In the first two months of 2024 ending February 29, 2024, the Company delivered an additional approximately $7 million of oral TPOXX® to six countries in Europe, completing greater than 95% of deliveries under the $18 million of firm commitment orders from 13 countries under the European Commission’s DG HERA (Health Emergency Preparedness and Response Authority) joint procurement mechanism, which was announced by the Company in October 2022.
Added
The PALM 007 study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the DRC with mpox who received TPOXX® compared to patients who received placebo.
Removed
Additionally, $0.7 million of oral TPOXX® was delivered to the Canada Department of National Defence ("CDND") in February 2024. These deliveries were made in connection with orders and contracts under the International Promotion Agreement (defined and discussed below). Through the International Promotion Agreement, Meridian Medical Technologies, Inc.
Added
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.
Removed
("Meridian") is the counterparty to international contracts under which orders are placed for the purchase of oral TPOXX®.
Added
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.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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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. 42 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. 40 Table of Contents

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