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What changed in SIGA TECHNOLOGIES INC's 10-K — 2022 vs 2023

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Paragraph-level year-over-year comparison of SIGA TECHNOLOGIES INC's 2022 and 2023 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 2023 report.

+194 added−200 removedSource: 10-K (2024-03-12) vs 10-K (2023-03-02)

Top changes in SIGA TECHNOLOGIES INC's 2023 10-K

194 paragraphs added · 200 removed · 153 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

48 edited+8 added−11 removed108 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 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 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 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 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 11 Table of Contents 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 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, 2024 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 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 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.
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.
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").
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").
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 and recognized the related revenue in September 2022. On September 28, 2022, the Company and the DoD signed a new procurement contract ("DoD Contract #2").
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").
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 approximately $3.8 million of oral TPOXX®.
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®.
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 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 $2.7 billion.
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, 2022, 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, 2023, the budget for annual spending by the U.S.
In addition to the patents listed in the above chart, the principal and material patent applications covering TPOXX® include patent filings in multiple jurisdictions, including the United States, Europe, Asia, Australia, and other commercially significant markets. We hold 25 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, 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 receiving payments for API deliveries, Grace is also paid for related services, such as stability testing. The Company’s agreement with Grace is currently scheduled to expire upon the earlier of: (i) September 30, 2023, or (ii) the fulfillment of delivery obligations under the 19C BARDA Contract.
In addition to receiving payments for API deliveries, Grace is also paid for related services, such as stability testing. The Company’s agreement with Grace was scheduled to expire upon the earlier of: (i) September 30, 2023, or (ii) the fulfillment of delivery obligations under the 19C BARDA Contract.
BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term, including during the base period of performance.
BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term.
As such, until June 28, 2024, 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 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®.
International Promotion Agreement Under the terms of the International Promotion Agreement, which has an effective date of May 31, 2019 and 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.
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.
For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 64,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP.
For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 32,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP.
Notice has not been provided by either party and, as such, the agreement has been automatically extended to March 1, 2024. The agreement can be terminated earlier than March 1, 2024 under certain conditions.
Notice has not been provided by either party and, as such, the agreement has been automatically extended to March 1, 2025. The agreement can be terminated earlier than March 1, 2025 under certain conditions.
In the second quarter of 2022, the Company delivered and recognized revenue of $3.6 million for the delivery of oral TPOXX® to the DoD, fulfilling the firm commitment in DoD Contract #1.
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.
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, 2023, we had 39 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 and Research Facilities As of February 15, 2024, we had 45 full-time employees.
In connection with the global response to an mpox outbreak, a series of observational and randomized, placebo-controlled clinical trials were initiated, starting in the third quarter of 2022, to assess the safety and efficacy of TPOXX® in participants with mpox.
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.
The Company estimates that sales of the IV formulation under this contract (under current terms), assuming the IV FDP Options were 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%. Under the terms of this contract, exercise of procurement options is at the sole discretion of BARDA.
The Company's agreement with Roquette has no minimum amount of manufacturing services that must be used. The Company’s agreement with Roquette has an initial term that ends on December 31, 2023.
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.
As of December 31, 2022, 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 $18.8 million for other base period activities.
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.
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 valued at a total of $ 19.5 million, with an initial award of $ 12.4 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").
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").
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 has recently completed enrollment of an immunogenicity trial and is planning to meet target enrollment for an expanded safety trial in March of 2023.
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.
As of December 31, 2022, 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 September 30, 2023.
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.
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 $268.9 million.
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.
The base period of performance specifies potential payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 20,000 courses of final drug product of IV TPOXX® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities.
The base period of performance specifies potential payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 10,000 courses (as currently defined within the contract as being 28 vials) of final drug product of IV TPOXX® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities.
As of December 31, 2022, 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 of five years, approximately $268.9 million of payments are related to exercised options and up to approximately $281.9 million of payments are currently specified as unexercised options.
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.
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. Manufacturing SIGA does not have a manufacturing infrastructure and does not intend to develop one for the manufacture of TPOXX®.
Government’s right to terminate or restructure a contract or grant for convenience at any time. As such, the Company may not be eligible to receive all available funds. Manufacturing SIGA does not have a manufacturing infrastructure and does not intend to develop one for the manufacture of TPOXX®.
At the end of the above-mentioned contract term, the agreement will renew for successive one-year renewal terms until either the Company or Grace provides notice of non-renewal at least 90 days prior to the expiration date of a term. 6 Table of Contents Microsize micronizes and tests API for use in oral TPOXX®.
Upon September 30, 2024, and each anniversary thereafter, the agreement will renew for successive one-year renewal terms until either the Company or Grace provides notice of non-renewal at least 90 days prior to the expiration date of a term. 6 Table of Contents Microsize micronizes and tests API for use in oral TPOXX®.
Additionally, 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®, and procurement activities.
There are options for the following activities: payments of up to $225.1 million for the delivery of oral TPOXX® to the Strategic Stockpile; payments of up to $51.2 million for the manufacture of courses of IV FDP, of which up to $20.5 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP; and payments of up to approximately $5.6 million for supportive procurement activities.
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.
As of January 10, 2023, the TPOXX® patent portfolio has seven patent families consisting of 29 U.S. utility patents, 101 issued foreign patents, two U.S. utility patent applications, and 23 foreign patent applications. The principal and material issued patents covering TPOXX® are described in the table below.
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.
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. 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 has automatically extended to December 31, 2024. Patheon manufactures, tests and packages IV TPOXX®.
If BARDA decides to only exercise the remaining IV BDS Options, then the Company would receive payments up to $20.5 million; alternatively, if BARDA decides to exercise all the remaining IV BDS Options and IV FDP Options, then the Company would receive payments up to $51.2 million.
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.
The first three randomized, placebo-controlled clinical trials to be launched were in the United States, United Kingdom and the Democratic Republic of Congo ("DRC"). These randomized clinical trials are now enrolling patients to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease.
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.
There are exercised options for the following activities: payments up to $11.2 million for the procurement of raw materials used in the 2020 manufacture of certain courses of oral TPOXX®; payments up to $213.9 million for the delivery of up to 726,140 courses of oral TPOXX®; payments up to $25.6 million for the manufacture of courses of IV FDP, of which $10.2 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®.
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®.
Government 19C BARDA Contract On September 10, 2018, the Company entered into a contract with BARDA pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX® to the Strategic Stockpile, and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of IV TPOXX®.
Biomedical Advanced Research and Development Authority ("BARDA") pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX® to the Strategic Stockpile, and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of IV TPOXX®.
To date, BARDA has exercised one of the three IV BDS options and one of the three IV FDP options, both of which were exercised simultaneously in 2022.
To date, BARDA has exercised two of the three IV BDS options and two of the three IV FDP options.
The following corporate governance related documents are also available on our website: • Audit Committee Charter; • Compensation Committee Charter; • Nominating and Corporate Governance Committee Charter; • Code of Ethics and Business Conduct; To review these documents, access www.siga.com and click on “Investors” and “Corporate Governance.” Any of the above documents can also be obtained in print by any shareholder upon request to the Secretary, SIGA Technologies, Inc., 31 E 62nd Street, 5th floor, New York, New York 10065. 16 Table of Contents
The following corporate governance related documents are also available on our website: • Audit Committee Charter; • Compensation Committee Charter; • Nominating and Corporate Governance Committee Charter; and • Code of Ethics and Business Conduct. To review these documents, access www.siga.com and click on “Investors” and “Corporate Governance.” 16 Table of Contents
Based on prior product delivery activity, and current FDA-approved shelf life of oral TPOXX®, the Company estimates that approximately 920,000 courses of smallpox antiviral treatment would need to be delivered to the Strategic Stockpile in 2023 and 2024 in order to maintain historical stockpile levels of unexpired TPOXX® treatment in the Strategic Stockpile. U.S.
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.
BARDA may choose to exercise any, all, or none of these options in its sole discretion. The 19C BARDA Contract includes: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 64,000 courses of IV TPOXX®; and three separate IV FDP Options, each providing for 64,000 courses of final drug product of IV TPOXX®.
The 19C BARDA Contract includes: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 32,000 courses (as currently defined within the contract) of IV TPOXX®; and three separate IV FDP Options, each providing for 32,000 courses of final drug product of IV TPOXX®.
Provided unblinded results from these trials are supportive of a regulatory submission, the Company expects to commence in 2023 the preparation of a supplemental New Drug Application (“Supplemental NDA”) for a smallpox PEP indication for oral TPOXX®, targeting early 2024 for its submission to the FDA.
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.
Study investigators aim to enroll more than 450 participants, including children weighing ≥3 kg and women who are pregnant or breastfeeding, at clinical sites in the DRC. The Company may be able to use data from the trials noted above to potentially pursue an FDA label expansion of oral TPOXX® for an indication covering the treatment of mpox.
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.
As of December 31, 2022, the Company had received $225.1 million for the delivery (and related procurement of raw materials) of oral TPOXX® to the Strategic Stockpile; $10.2 million for the completed manufacture of IV BDS; and $7.3 million in connection with post-marketing activities for oral and IV TPOXX®.
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®.
(“Meridian”) is the counterparty to international contracts under which orders are placed for the purchase of oral TPOXX®. The Public Health Agency of Canada (“PHAC”) and the CDND are among the contracting parties for the purchase of oral TPOXX® (see below for a summary description of these contracts).
("Meridian") is the counterparty to international contracts under which orders are placed for the purchase of oral TPOXX®.
The DoD Contract #2 includes a firm commitment for the DoD to procure approximately $5.2 million of oral TPOXX®, and an option, exercisable at the sole discretion of the DoD for the procurement of approximately $5.5 million of oral TPOXX®. 4 Table of Contents International Procurement Contracts In 2022, the Company received firm commitment orders from 13 international customers (including Canada) for the delivery of approximately $77 million of oral TPOXX®, of which approximately $39 million is for Canada and approximately $38 million is for jurisdictions in Europe, Asia-Pacific, and the Middle East.
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®.
Additionally, the contract with the Canadian Department of National Defence ("CDND") has an option until March 31, 2024, exercisable at the sole discretion of CDND, for the purchase of up to an additional $6 million of oral TPOXX®.
In addition to the above-mentioned orders and deliveries, the Company has a contract with the CDND under which the CDND has an option until December 31, 2025, exercisable at its sole discretion, for the purchase of up to an additional $6.7 million of oral TPOXX®. As an international contract, this contract is also administered under the International Promotion Agreement.
In subsequent modifications, the DoD increased the scope and the available funding under the PEP Label Expansion R&D Contract to approximately $27 million. The period of performance for this contract, as modified, terminates on January 31, 2025. Contracts and grants include, among other things, options that may or may not be exercised at the U.S. Government’s discretion.
As of December 31, 2023, the Company invoiced the full amount of available funding. Contracts and grants include, among other things, options that may or may not be exercised at the U.S. Government’s discretion. Moreover, contracts and grants contain customary terms and conditions including the U.S.
On April 3, 2020, the Company announced that the CDND awarded a contract (the "Canadian Military Contract") to Meridian, pursuant to which the CDND would purchase up to approximately $14 million of oral TPOXX® over four years in an option-based contract. Prior to 2022, approximately $4 million of oral TPOXX® had been ordered and delivered to the CDND.
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.
With respect to the $77 million of firm commitment orders that were received this year, approximately $71 million of oral TPOXX® was delivered and recorded as revenue in 2022, and the remaining order is expected to be fulfilled by July 31, 2023. Through an International Promotion Agreement (defined and discussed below), Meridian Medical Technologies, Inc.
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.
Removed
Study of Tecovirimat for Human Monkeypox Virus (STOMP; A5418) is a U.S.-based clinical trial sponsored by the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the National Institutes of Health. The NIAID-funded AIDS Clinical Trials Group is leading the study, which may later expand to international sites.
Added
Government 19C BARDA Contract On September 10, 2018, the Company entered into a contract with the U.S.
Removed
Study investigators aim to enroll more than 500 participants, including children and those who are pregnant or breastfeeding, at clinical research sites. The trial will also include an open label arm that will include children, pregnant/breastfeeding individuals and those who are immunocompromised or have severe mpox disease.
Added
In October 2023, the contract was modified so that a course of IV TPOXX® was redefined within the contract from being 14 vials to being 28 vials; as such, the 19C BARDA Contract currently specifies 106,000 courses of IV TPOXX® (for the same payment amount as originally specified).
Removed
PLATINUM is a U.K.-based clinical trial commissioned and funded by the National Institute for Health Care and Research. The trial is led by researchers at Oxford University and aims to recruit at least 500 participants, including children weighing ≥13 kg, across the U.K. PALM 007 is a DRC-based clinical trial sponsored by NIAID and Institute National de Recherche Biomédicale.
Added
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.
Removed
Unexercised options specify potential payments up to approximately $281.9 million in total (if all such options are exercised).
Added
BARDA may choose to exercise any, all, or none of these options in its sole discretion.
Removed
On January 13, 2021, PHAC awarded a contract to Meridian (the “PHAC Contract”) for the purchase of up to approximately $33 million of oral TPOXX® (tecovirimat) within five years. In March 2022 and July 2022, PHAC executed amendments in which total procurement of oral TPOXX® under the PHAC Contract was increased to an amount of approximately $45 million.
Added
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.
Removed
Prior to 2022, approximately $10 million of oral TPOXX® had been ordered and delivered to PHAC. During 2022, all remaining amounts under the PHAC Contract of approximately $35 million of oral TPOXX® were delivered to PHAC and recognized as revenue.
Added
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.
Removed
In 2022, approximately $4 million of oral TPOXX® was delivered and recognized as revenue under this contract, leaving approximately $6 million of unexercised options, exercisable at the sole discretion of CDND, remaining under this contract.
Added
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.
Removed
The above-listed contract awards were coordinated between SIGA and Meridian under the international promotion agreement (as amended, the "International Promotion Agreement") that has an effective date of May 31, 2019.
Added
On September 30, 2023, the contract term automatically renewed for a one-year term.
Removed
Under the International Promotion Agreement, Meridian is the counterparty in connection with international contracts for oral TPOXX® and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder.
Removed
As such, since the delivery obligations under the 19C BARDA Contract have not been fulfilled yet, the contract term continues.
Removed
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.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

38 edited+14 added−12 removed151 unchanged
Biggest changeWhile the Company does not currently expect such delays to have a material adverse impact on the financial condition of the Company or its long-term operating performance, and while the COVID-19 pandemic has not adversely affected the liquidity position of the Company, the Company cannot give assurances as to the full extent of the impact at this time.
Biggest changeWhile 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.
Our certificate of incorporation allows our Board of Directors to issue up to 20,000,000 shares of preferred stock and to fix the voting powers, designations, preferences, rights and qualifications, limitations or restrictions of these shares without any further vote or action by the stockholders.
Our certificate of incorporation allows our Board of Directors (the "Board") to issue up to 20,000,000 shares of preferred stock and to fix the voting powers, designations, preferences, rights and qualifications, limitations or restrictions of these shares without any further vote or action by the stockholders.
General Risk Factors Global infectious disease outbreaks, such as the COVID-19 pandemic, or climate-related matters could negatively impact the global economy on a broad scale and our business in particular. The COVID-19 pandemic has caused significant societal and economic disruption.
General Risk Factors Global infectious disease outbreaks, such as the COVID-19 pandemic, or climate-related matters could negatively impact the global economy on a broad scale and our business in particular. The COVID-19 pandemic caused significant societal and economic disruption.
We cannot predict the 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. Our current international revenues depend heavily on the success of the efforts of Meridian pursuant to an International Promotion Agreement.
Risks Related to Commercial 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.
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.
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 ongoing COVID-19 pandemic has 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. The COVID-19 pandemic increased employment changes in many industries, including ours.
If cash flows from the 19C BARDA Contract are significantly different from expectations, or if operating expenses or other expenses meaningfully exceed our expectations or cannot be adjusted accordingly, then our business, financial condition, results of operations and prospects could be materially adversely affected. 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 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.
Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization or persons with access to systems inside our organization.
Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, we are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, phishing attacks, persons inside our organization or persons with access to systems inside our organization.
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 may depend in part 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. 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.
Government’s commitment to maintaining or expanding its stockpile of TPOXX®. Failure to secure and perform additional contracts after the 19C BARDA Contract to substantially maintain or expand the stockpile of TPOXX® could have a material adverse effect on our long-term business, financial condition, results of operations and prospects.
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.
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 a base period of performance and options for the performance of certain future activities.
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.
If a third-party provider fails to comply with applicable laws and regulations, fails to meet expected deadlines, fails to conduct trials in accordance with regulatory requirements or our stated protocols, experiences shortages or delays, or otherwise does not carry out its contractual duties to us, or encounters physical damage or natural disaster or disruptions at its facilities, for example as a result of the COVID-19 pandemic, our ability to meet our obligations under 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 to develop, obtain approval of and commercialization of other indications of TPOXX® or other drug candidates, could be significantly impaired or delayed.
The continuing direct and indirect impacts of the pandemic are significant and broad-based, including supply chain disruptions and labor shortages that started during the pandemic and continue to represent business and financial risks.
The direct and indirect impacts of the pandemic were significant and broad-based, including supply chain disruptions and labor shortages that started during the pandemic and continue to represent business and financial risks.
Remaining unexercised options under current government procurement contracts, including the 19C BARDA Contract, are predominately fixed-price. We expect that our future contracts with the U.S. Government and foreign governments for TPOXX®, as well as contracts for other biodefense product candidates, would also be fixed-price arrangements.
Remaining unexercised options under current government procurement contracts, including the 19C BARDA Contract, are predominately fixed-price. We expect that our future contracts with the U.S. Government and foreign governments for TPOXX®, as well as contracts for other biodefense product candidates, would also be predominantly fixed-price arrangements with potential moderate annual increases.
As of February 15, 2023, directors, executive officers and principal stockholders (excluding institutional investors) beneficially owned approximately 35% of our outstanding common stock.
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.
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, 2022, more than 85% of 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, 2023, most of the remaining contract value of the 19C BARDA Contract is tied to options exercisable in the sole discretion of BARDA.
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, 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; and • increased management and infrastructure costs.
Debt financing arrangements, if available, may require us to pledge certain assets or enter into covenants that could restrict our business activities or our ability to incur further indebtedness and may be at interest rates and contain other terms that are not favorable to our stockholders. 28 Table of Contents Item 1B. Unresolved Staff Comments None.
Debt financing arrangements, if available, may require us to pledge certain assets or enter into covenants that could restrict our business activities or our ability to incur further indebtedness and may be at interest rates and contain other terms that are not favorable to our stockholders.
Our cash flows may fall short of our projections or be delayed, or our expenses may increase, which could result in our capital being consumed significantly faster than anticipated.
Our cash flows may fall short of our projections or be delayed, or our expenses may increase, including as a result of inflation or interest rate increases, which could result in our capital being consumed significantly faster than anticipated.
We cannot predict with certainty how, if at all, this may impact SIGA. On January 17, 2023, we announced that Phillip Gomez had provided notice of his intention to retire as our Chief Executive Officer and a member of our Board in 2023. The Board has initiated a search for Dr. Gomez’s successor, and Dr.
We cannot predict with certainty how, if at all, this may impact SIGA. On January 17, 2023, we announced that Phillip Gomez had provided notice of his intention to retire as our Chief Executive Officer and a member of our Board in 2023. On January 26, 2024, Dr. Gomez retired from the Company and on January 27, 2024, Dr.
As of January 10, 2023, the TPOXX® patent portfolio has seven patent families consisting of 29 U.S. utility patents, 101 issued foreign patents, two U.S. utility patent applications, and 23 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 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.
Risks Related to Regulatory Approvals If we are not able to obtain regulatory approvals for certain additional indications of TPOXX® from the FDA, we may not be able to realize the full benefits of any BARDA contracts or may not be able to commercialize such indications other than through existing sales to BARDA, and our ability to generate future revenue could be materially impaired.
Risks Related to Regulatory Approvals If we are not able to obtain regulatory approvals for certain additional indications of TPOXX® from the FDA, we may not be able to realize the full benefits of any U.S. Government contracts or may not be able to commercialize such indications other than through existing sales to the U.S.
Government , healthcare reform and controls on healthcare spending in the U.S. may nonetheless limit the prices we charge for our products and the amounts that we can sell.
If we sell TPOXX ® to non-government customers and are able to charge such customers higher prices than we charge to the U.S. Government , healthcare reform and controls on healthcare spending in the U.S. may nonetheless limit the prices we charge for our products and the amounts that we can sell.
If our contract manufacturers are unable to generate enough materials to meet commercial obligations or satisfy clinical needs, for example as a result of disruption resulting from the COVID-19 pandemic, the success of drug products may be jeopardized.
If our contract manufacturers are unable to generate enough materials to meet commercial obligations or satisfy clinical needs, the success of drug products may be jeopardized.
Indictment alone under the FCPA can lead to suspension of the right to do business with the U.S. Government until the pending claims are resolved and conviction under the FCPA can result in long-term disqualification as a government contractor.
Indictment alone under the FCPA can lead to suspension of the right to do business with the U.S. Government until the pending claims are resolved and conviction under the FCPA can result in long-term disqualification as a government contractor. The SEC may also suspend or bar issuers from trading securities on U.S. stock exchanges for violations of the FCPA.
If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs.
Also, increasing use of artificial intelligence may increase the risk of cyber attacks. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs.
Additionally, we may rely on a third-party provider, or multiple providers, to store or transport a portion of the stockpile of IV TPOXX® under the 19C BARDA Contract, 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® under the 19C BARDA Contract, thereby entrusting such vendor or vendors with the care and handling of a substantial portion of IV TPOXX® inventory.
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. As a result, we are subject to Meridian’s ability to collect and remit payment to us in a timely manner.
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.
The search for and transition to a new Chief Executive Officer may result in disruptions to our business and uncertainty among our customers, employees and investors, 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.
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.
Meridian could fail to perform such obligations adequately, cease operations abruptly or become insolvent, or our relationships with Meridian may otherwise change adversely. If the foregoing were to occur, there could be an adverse impact on our business, financial condition and operating results as a result.
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.
While the IRA is still subject to rulemaking (with more information to come via guidance documents from the responsible federal agencies), the IRA, as written, will, among other changes, give HHS the ability and authority to directly negotiate with manufacturers the price that Medicare will pay for certain high-priced drugs.
The IRA, as written, among other changes, gives HHS the ability and authority to directly negotiate with manufacturers the price that Medicare will pay for certain high-priced drugs.
While we believe our current cash position is strong, our ability to continue to fund future operations will be substantially impacted by cash flows from the 19C BARDA Contract, which may not be sufficient if BARDA elects, in its sole discretion, not to exercise or to significantly delay exercise of some or all of the remaining options under the 19C BARDA Contract.
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.
Our future international revenues will likely depend heavily on the success of the efforts of Meridian pursuant to the International Promotion Agreement, which may not be successful. 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.
As long as the International Promotion Agreement is in force, our future international revenues will likely depend heavily on the success of the efforts of Meridian pursuant to the International Promotion Agreement, which may not be successful.
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 Our stock repurchase program could affect the price of our common stock and increase volatility and may be suspended or terminated at any time, which may result in a decrease in the trading price of our common stock.
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.
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 of the filing date of this report, the Company has not identified or been notified by government customers of impediments to the continued full performance of their government contracts.
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.
The IRA will also require 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). At this time, we cannot predict the implications the IRA provisions will have on our business.
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.
Any of the above occurrences could harm or prevent future sales of the affected product or could increase the costs and expenses of commercializing and marketing these products. If we sell TPOXX ® to non-government customers and are able to charge such customers higher prices than we charge to the U.S.
Any of the above occurrences could harm or prevent future sales of the affected product or could increase the costs and expenses of commercializing and marketing these products, which could adversely affect our business, financial condition and results of operations.
The SEC may also suspend or bar issues from trading securities on United States exchanges for violations of the FCPA’s accounting provisions. We could incur net losses in the future 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 options are not exercised under the 19C BARDA Contract.
Removed
On August 2, 2021, our Board of Directors authorized a new share repurchase program for up to $50 million of our common stock through December 31, 2023.
Added
Government, and our ability to generate future revenue could be materially impaired.
Removed
This stock repurchase program does not obligate the Company to repurchase any dollar amount or number of shares of our common stock and may be suspended or discontinued at any time, which could cause the market price of our common stock to decline.
Added
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.
Removed
Repurchases pursuant to our stock repurchase program could affect the price of our common stock and increase its volatility.
Added
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.
Removed
Important factors that could cause us to limit, suspend or delay the Company’s stock repurchases, without prior notice, and that could in any event impact management’s exercise of its discretion as to the amount and timing of such repurchases, include the timing of exercise of procurement options under government contracts, alternative opportunities for strategic uses of cash, the stock price of the Company’s common stock, market conditions, and other corporate liquidity requirements and priorities.
Added
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.
Removed
The existence of our stock repurchase program could cause the price of our common stock to be higher than it would be in the absence of such a program and could potentially reduce the market liquidity for our common stock.
Added
If third parties on whom we rely for packaging and delivery of our products, are unable to meet the target timing for deliveries to our customers, product revenue recognition may be delayed and our business could suffer.
Removed
Additionally, repurchases under our stock repurchase program would diminish our cash reserves, which could impact our ability to pursue other opportunities, further develop our technology or adversely affect our operating results.
Added
Relying on third parties for storage, packaging and delivery of our products exposes us to risks, including reduced control over timing for delivery and quality assurance.
Removed
There can be no assurance that any stock repurchases would enhance stockholder value because the market price of our common stock may decline below the levels at which we repurchased such shares. Any failure to repurchase shares could negatively impact our reputation, investor confidence in us and our stock price.
Added
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.
Removed
A future issuance of preferred stock may adversely affect the rights of the holders of our common stock.
Added
Failure to meet our scheduled product deliveries to our customers could cause the loss of sales, delayed revenue recognition or an increase in our costs, which could adversely affect our business, financial condition and results of operations.
Removed
With regard to day-to-day operations, the COVID-19 pandemic, and the secondary effects of the pandemic, have at times slowed the pace of execution of government contracts as well as new contract generation.
Added
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.
Removed
Additionally, the COVID-19 pandemic, and the secondary effects of the pandemic have increased the risk of delays in connection with a broad range of operational activities, including: supply chain procurement of raw materials and manufacturing; and certain research and development activities, such as those that involve clinical trials.
Added
If one or multiple financial institutions fail, our deposit or investment accounts could be adversely affected due to the loss of or delay in obtaining access to all or a portion of our uninsured funds.
Removed
Furthermore, the pandemic and related secondary effects could result in a slower pace of future product deliveries if there are shortages or delays in the receipt by the supply chain of raw materials or supplies, or if labor shortages become more acute.
Added
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.
Removed
Gomez is expected to remain in his current role as Chief Executive Officer until his successor commences service as Chief Executive Officer of the Company.
Added
The balance held in these accounts regularly exceeds the Federal Deposit Insurance Corporation (“FDIC”), standard deposit insurance limit or similar government guarantee schemes, or in the case of investment accounts, is not insured.
Added
If one or multiple financial institutions in which we hold such funds fails or is subject to significant adverse conditions in the financial or credit markets, we could be subject to a risk of loss of all or a portion of such uninsured funds or be subject to a delay in accessing all or a portion of such uninsured funds.
Added
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.

Item 2. Properties

Properties — owned and leased real estate

3 edited+1 added−0 removed0 unchanged
Biggest changeUntil 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.
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.
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. In Corvallis, we lease approximately 10,276 square feet.
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.
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.
In the second quarter of 2021, we exercised the second renewal option, which extended the lease expiration date to December 31, 2024.
Added
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.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

3 edited+5 added−1 removed1 unchanged
Biggest changeThe timing and actual number of shares repurchased will depend 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. 30 Table of Contents Performance Graph The following line graph compares the cumulative total stockholder return through December 31, 2022, assuming reinvestment of dividends, by an investor who invested $100 on December 31, 2017 in each of (i) our common stock; (ii) the Nasdaq Composite; and (iii) the Nasdaq Biotech Composite. 2017 2018 2019 2020 2021 2022 SIGA Technologies, Inc. $ 100 $ 163 $ 98 $ 150 $ 155 $ 152 NASDAQ Composite Index $ 100 $ 96 $ 130 $ 187 $ 227 $ 152 NASDAQ Biotech Composite Index $ 100 $ 91 $ 113 $ 142 $ 141 $ 126 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 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
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 28 holders of record as of February 15, 2023.
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.
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.” 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, 2022 to October 31, 2022 - $ - - $ 35,325,830 November 1, 2022 to November 30, 2022 88,705 9.22 88,705 34,507,731 December 1, 2022 to December 31, 2022 260,252 7.83 260,252 32,469,204 Total 348,957 $ 8.19 348,957 On March 5, 2020, the Company announced that the Board of Directors authorized a share repurchase program under which the Company may repurchase, from time to time, up to an aggregate of $50 million of the Company’s common stock through December 31, 2021.
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
This program has been fulfilled with the maximum amount being used to repurchase shares. On August 5, 2021, the Company announced that the Board of Directors authorized an additional share repurchase program under which the Company may repurchase up to $50 million of the Company's common stock through December 31, 2023.
Added
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.
Added
The special dividend was paid on June 1, 2023 to shareholders of record at the close of business on May 16, 2023.
Added
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.
Added
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.
Added
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

61 edited+13 added−23 removed36 unchanged
Biggest changeAs of December 31, 2022, remaining revenue to be recognized in the future under the PEP Label Expansion R&D Contract is up to $6.4 million. Revenue from the performance obligation under the PEP Label Expansion R&D Contract is recognized over time using an input method using costs incurred to date relative to total estimated costs at completion.
Biggest changeRevenue from the performance obligation under the PEP Label Expansion R&D Contract was recognized over time using an input method using costs incurred to date relative to total estimated costs at completion. Contracts and grants include, among other things, options that may or may not be exercised at the U.S. Government’s discretion.
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").
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").
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 and recognized the related revenue in September 2022. On September 28, 2022, the Company and the DoD signed a new procurement contract ("DoD Contract #2").
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").
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 is complex, subject to many variables and requires significant judgment.
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.
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 approximately $3.8 million of oral TPOXX®.
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®.
BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term, including during the base period of performance.
BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term.
For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 64,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP.
For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 32,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP.
Our accounts receivable balance as of December 31, 2022 primarily reflects sales of oral TPOXX® to various international countries, of which approximately $35 million was received by the Company in February 2023. The remaining amounts of the receivable balance are expected to be collected during the first or second quarter of 2023.
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.
In the second quarter of 2022, the Company delivered and recognized revenue of $3.6 million for the delivery of oral TPOXX® to the DoD, fulfilling the firm commitment in DoD Contract #1.
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.
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, 2022 and 2021 Revenues from product sales and supportive services for the years ended December 31, 2022 and 2021 were $86.7 million and $126.8 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. 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.
For the years ended December 31, 2022 and December 31, 2021, we recorded a gain of approximately $0.4 million and $0.1 million, respectively, reflecting a decrease in the fair value of the liability-classified warrant primarily due to the decrease in our stock price. 39 Table of Contents Other income, net for the years ended December 31, 2022 and 2021 was $1.0 million and $0.1 million, respectively.
For the year ended December 31, 2022, we recorded a gain of approximately $0.4 million, reflecting a decrease in the fair value of the liability-classified warrant primarily due to the decrease in our stock price. 39 Table of Contents Other income, net for the years ended December 31, 2023 and 2022 was $4.2 million and $1.0 million, respectively.
Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (filed with the SEC on March 3, 2022) for additional discussion of our financial condition and results of operations for the year ended December 31, 2021, as well as our financial condition and results of operations for the year ended December 31, 2021 compared to the year ended December 31, 2020.
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.
In connection with the global response to an mpox outbreak, a series of observational and randomized, placebo-controlled clinical trials were initiated, starting in the third quarter of 2022, to assess the safety and efficacy of TPOXX® in participants with mpox.
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.
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 $268.9 million.
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 Company estimates that sales of the IV formulation under this contract (under current terms), assuming the IV FDP Options were 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%. Under the terms of this contract, exercise of procurement options is at the sole discretion of BARDA.
Procurement Contracts with the U.S. Government 19C BARDA Contract On September 10, 2018, the Company entered into a contract with the U.S.
Government 19C BARDA Contract On September 10, 2018, the Company entered into a contract with the U.S.
As of December 31, 2022, 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 $18.8 million for other base period activities.
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.
The DoD Contract #2 includes a firm commitment for the DoD to procure approximately $5.2 million of oral TPOXX®, and an option, exercisable at the sole discretion of the DoD for the procurement of approximately $5.5 million of oral TPOXX®.
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®.
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, 2021, we recognized a tax provision of $19.9 million on pre-tax income of $89.3 million.
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.
The base period of performance specifies potential payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 20,000 courses of final drug product of IV TPOXX® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities.
The base period of performance specifies potential payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 10,000 courses (as currently defined within the contract as being 28 vials) of final drug product of IV TPOXX® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities.
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®.
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®.
Contracts and grants include, among other things, options that may or may not be exercised at the U.S. Government’s discretion. Moreover, contracts and grants contain customary terms and conditions including the U.S. 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. As such, the Company may not be eligible to receive all available funds.
Under this method, we reconcile net income to cash flows from operating activities by adjusting net income for those items that impact net income but may not result in actual cash receipts or payments during the period.
Operating Activities We prepare our consolidated statement of cash flows using the indirect method. Under this method, we reconcile net income to cash flows from operating activities by adjusting net income for those items that impact net income but may not result in actual cash receipts or payments during the period.
There are options for the following activities: payments of up to $225.1 million for the delivery of oral TPOXX® to the Strategic Stockpile; payments of up to $51.2 million for the manufacture of courses of IV FDP, of which up to $20.5 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP; and payments of up to approximately $5.6 million for supportive procurement activities. 34 Table of Contents The options related to IV TPOXX® are divided into two primary manufacturing steps.
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.
Our effective tax rate for the year ended December 31, 2021 was 22.2% and differs from the statutory rate of 21% primarily as a result of non-deductible executive compensation under IRC Section 162(m), and state and local taxes.
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.
The 19C BARDA Contract includes: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 64,000 courses of IV TPOXX®; and three separate IV FDP Options, each providing for 64,000 courses of final drug product of IV TPOXX®.
The 19C BARDA Contract includes: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 32,000 courses (as currently defined within the contract) of IV TPOXX®; and three separate IV FDP Options, each providing for 32,000 courses of final drug product of IV TPOXX®.
As of December 31, 2022, 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 of five years, approximately $268.9 million of payments are related to exercised options and up to approximately $281.9 million of payments are currently specified as unexercised options.
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.
Research Agreements and Grants In July 2019, the Company was awarded a multi-year research contract valued at a total of $19.5 million, with an initial award of $12.4 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").
Additionally, 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®, and procurement activities.
Net cash provided by operations for the years ended December 31, 2022 and 2021 was $41.6 million and $11.5 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.
In connection with a potential FDA label expansion of oral TPOXX® for an indication covering smallpox post-exposure prophylaxis (“PEP”), the Company has recently completed enrollment of an immunogenicity trial and is planning to meet target enrollment for an expanded safety trial in March of 2023.
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.
For the year ended December 31, 2022, the receipt of approximately $80 million for the product delivery and acceptance of oral TPOXX® courses delivered to the Strategic Stockpile in December 2021, as well as the receipt of approximately $27 million in connection with 2022 product deliveries and advance payments were partially offset by the payment of $31 million of federal and state income taxes; an increase in inventory investment in connection with broadening of the customer base for TPOXX® and mitigation of increasing general supply chain risks; and costs in relation to customary operating activities.
For the year ended December 31, 2022, the receipt of approximately $80 million for the product delivery and acceptance of oral TPOXX® courses delivered to the Strategic Stockpile in December 2021, as well as the receipt of approximately $27 million in connection with 2022 product deliveries and advance payments were partially offset by the payment of $31 million of federal and state income taxes; an increase in inventory investment in connection with broadening of the customer base for TPOXX® and mitigation of increasing general supply chain risks; and costs in relation to customary operating activities. 40 Table of Contents On December 31, 2023 and 2022, our accounts receivable balance was approximately $21.1 million (which includes approximately $10.3 million of unbilled receivables) and $45.4 million, respectively.
If BARDA decides to only exercise the remaining IV BDS Options, then the Company would receive payments up to $20.5 million; alternatively, if BARDA decides to exercise all the remaining IV BDS Options and IV FDP Options, then the Company would receive payments up to $51.2 million.
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.
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.
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.
The first three randomized, placebo-controlled clinical trials to be launched were in the United States, United Kingdom and the Democratic Republic of Congo ("DRC"). These randomized clinical trials are now enrolling patients to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease.
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.
There are exercised options for the following activities: payments up to $11.2 million for the procurement of raw materials used in the 2020 manufacture of certain courses of oral TPOXX®; payments up to $213.9 million for the delivery of up to 726,140 courses of oral TPOXX®; payments up to $25.6 million for the manufacture of courses of IV FDP, of which $10.2 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®.
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®.
Such costs in 2021 were primarily associated with the manufacture and delivery of oral TPOXX® courses to the U.S. Government under the 19C BARDA Contract. Selling, general and administrative expenses for the years ended December 31, 2022 and 2021 were $35.1 million and $18.0 million, respectively.
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.
Under the International Promotion Agreement, Meridian is the counterparty in connection with international contracts for oral TPOXX® and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder. 35 Table of Contents International Promotion Agreement Under the terms of the International Promotion Agreement, which has an effective date of May 31, 2019 and 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.
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.
The warrant was fully exercised during the year ended December 31, 2022.
The warrant was fully exercised during the year ended December 31, 2022. For the year ended December 31, 2023, we recorded no activity.
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. 33 Table of Contents Impact of COVID-19 Pandemic The COVID-19 pandemic has caused significant societal and economic disruption.
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.
To date, BARDA has exercised one of the three IV BDS options and one of the three IV FDP options, both of which were exercised simultaneously in 2022.
To date, BARDA has exercised two of the three IV BDS options and two of the three IV FDP options.
The increase is mostly attributable to an increase in direct vendor-related expenses incurred in connection with an increase in activities under the PEP Label Expansion R&D Contract and the BARDA Contract. Changes in the fair value of the liability classified warrant to acquire common stock were recorded within the income statement.
The decrease is mostly attributable to lower direct vendor-related expenses incurred in connection with clinical activity, partially offset by an increase in regulatory costs associated with EMA regulatory submissions and related activities. Changes in the fair value of the liability classified warrant to acquire common stock were recorded within the income statement.
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. The Company has been delivering oral TPOXX® to the U.S. Strategic National Stockpile ("Strategic Stockpile") since 2013.
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.
Based on prior product delivery activity, and current FDA-approved shelf life of oral TPOXX®, the Company estimates that approximately 920,000 courses of smallpox antiviral treatment would need to be delivered to the Strategic Stockpile in 2023 and 2024 in order to maintain historical stockpile levels of unexpired TPOXX® treatment in the Strategic Stockpile. U.S.
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.
Uncertain tax positions are evaluated and adjusted as appropriate, while taking into account the progress of audits of various taxing jurisdictions. In August 2022, the Inflation Reduction Act (“IRA”) and CHIPS and Science Act (“CHIPS Act”) were both enacted.
Uncertain tax positions are evaluated and adjusted as appropriate, while taking into account the progress of audits of various taxing jurisdictions.
For the year ended December 31, 2021, we used $50,620 for capital expenditures. Financing Activities Cash used in financing activities for the years ended December 31, 2022 and 2021 was $46.0 million and $26.2 million, respectively. For the year ended December 31, 2022, we paid a special dividend of approximately $32.9 million.
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.
In connection with IV TPOXX®, SIGA announced on May 19, 2022 that the FDA approved this formulation for the treatment of smallpox. 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.
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.
As of December 31, 2022, the Company had received $225.1 million for the delivery (and related procurement of raw materials) of oral TPOXX® to the Strategic Stockpile; $10.2 million for the completed manufacture of IV BDS, which has been recorded as deferred revenue as of December 31, 2022; and $7.3 million in connection with post-marketing activities for oral and IV TPOXX®.
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, 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®.
Cost of sales and supportive services for the years ended December 31, 2022 and 2021 were $10.4 million and $16.6 million, respectively. 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®.
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.
Such revenues for the year ended December 31, 2021 include $112.5 million of sales of oral TPOXX® to the U.S. Government under the 19C BARDA Contract and $12.7 million of international sales of oral TPOXX®. Revenues from research and development contracts and grants for the years ended December 31, 2022 and 2021, were $24.1 million and $6.9 million, respectively.
Such revenues for the year ended December 31, 2023 include $97.9 million of oral TPOXX® sales to the U.S. Government under the 19C BARDA Contract; $21.3 million related to international sales of oral TPOXX®; and approximately $10.7 million of oral TPOXX® sales to the DoD.
Future Cash Requirements As of December 31, 2022, we have outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $33.8 million. 41 Table of Contents
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.
Provided unblinded results from these trials are supportive of a regulatory submission, the Company expects to commence in 2023 the preparation of a supplemental New Drug Application (“Supplemental NDA”) for a smallpox PEP indication for oral TPOXX®, targeting early 2024 for its submission to the FDA.
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.
Study investigators aim to enroll more than 450 participants, including children weighing ≥3 kg and women who are pregnant or breastfeeding, at clinical sites in the DRC. The Company may be able to use data from the trials noted above to potentially pursue an FDA label expansion of oral TPOXX® for an indication covering the treatment of mpox.
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.
(“Meridian”) is the counterparty to international contracts under which orders are placed for the purchase of oral TPOXX®. The Public Health Agency of Canada (“PHAC”) and the CDND are among the contracting parties for the purchase of oral TPOXX® (see below for a summary description of these contracts).
("Meridian") is the counterparty to international contracts under which orders are placed for the purchase of oral TPOXX®.
Additionally, the contract with the Canadian Department of National Defence ("CDND") has an option until March 31, 2024, exercisable at its sole discretion, for the purchase of up to an additional $6 million of oral TPOXX®.
In addition to the above-mentioned orders and deliveries, the Company has a contract with the CDND under which the CDND has an option until December 31, 2025, exercisable at its sole discretion, for the purchase of up to an additional $6.7 million of oral TPOXX®. As an international contract, this contract is also administered under the International Promotion Agreement.
The increase of $17.1 million mostly reflects promotion fees to Meridian incurred in connection with international sales that substantially increased from the comparable period in 2021. Research and development expenses were $22.5 million for the year ended December 31, 2022, an increase of approximately $12.6 million from the $9.9 million incurred during the year ended December 31, 2021.
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 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). Additionally, the Company sells the intravenous formulation of TPOXX® ("IV TPOXX®") to the U.S. Government.
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.
Other income primarily reflects interest income on the Company's cash and cash equivalent balance. The increase of approximately $0.9 million is driven by higher interest rates for 2022 when compared to 2021. For the year ended December 31, 2022, we recognized a tax provision of $10.2 million on pre-tax income of $44.1 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.
Liquidity and Capital Resources As of December 31, 2022, we had $98.8 million in cash and cash equivalents, compared with $103.1 million at December 31, 2021. Operating Activities We prepare our consolidated statement of cash flows using the indirect method.
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.
With respect to the $77 million of firm commitment orders that were received this year, approximately $71 million of oral TPOXX® was delivered and recorded as revenue in 2022, and the remaining order is expected to be fulfilled by July 31, 2023. Through an International Promotion Agreement (defined and discussed below), Meridian Medical Technologies, Inc.
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.
Our accounts receivable balance as of December 31, 2021 primarily reflects deliveries of approximately $79.7 million of oral TPOXX® to the U.S. Government in December 2021, for which we received full payment in January 2022. Investing Activities There were no cash-related investing activities for the year ended December 31, 2022.
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.
Removed
The EMA and MHRA approved label indication covers the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against smallpox. The Health Canada approved label indication covers the treatment of smallpox.
Added
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.
Removed
Study of Tecovirimat for Human Monkeypox Virus (STOMP; A5418) is a U.S.-based clinical trial sponsored by the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the National Institutes of Health. The NIAID-funded AIDS Clinical Trials Group is leading the study, which may later expand to international sites.
Added
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.
Removed
Study investigators aim to enroll more than 500 participants, including children and those who are pregnant or breastfeeding, at clinical research sites. The trial will also include an open label arm that will include children, pregnant/breastfeeding individuals and those who are immunocompromised or have severe mpox disease.
Added
In October 2023, the contract was modified so that a course of IV TPOXX® was redefined within the contract from being 14 vials to being 28 vials; as such, the 19C BARDA Contract currently specifies 106,000 courses of IV TPOXX® (for the same payment amount as originally specified).
Removed
PLATINUM is a U.K.-based clinical trial commissioned and funded by the National Institute for Health Care and Research. The trial is led by researchers at Oxford University and aims to recruit at least 500 participants, including children weighing ≥13 kg, across the U.K. PALM 007 is a DRC-based clinical trial sponsored by NIAID and Institute National de Recherche Biomédicale.
Added
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.
Removed
The continuing direct and indirect impacts of the pandemic are significant and broad-based, including supply chain disruptions and labor shortages that started during the pandemic and continue to represent business and financial risks.
Added
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.
Removed
As such, the Company is continually coordinating with service providers and vendors, in particular Contract Manufacturing Organizations ("CMOs") that constitute our supply chain, with respect to risks and mitigating actions. As of the filing date of this report, the Company has not identified or been notified by government customers of impediments to the continued full performance of their government contracts.
Added
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.
Removed
With regard to day-to-day operations, the COVID-19 pandemic, and the secondary effects of the pandemic, have at times slowed the pace of execution of government contracts as well as new contract generation.
Added
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.
Removed
Additionally, the COVID-19 pandemic, and the secondary effects of the pandemic have increased the risk of delays in connection with a broad range of operational activities, including: supply chain procurement of raw materials and manufacturing; and certain research and development activities, such as those that involve clinical trials.
Added
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.
Removed
Furthermore, the pandemic and related secondary effects could result in a slower pace of future product deliveries if there are shortages or delays in the receipt by the supply chain of raw materials or supplies, or if labor shortages become more acute.
Added
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.
Removed
While the Company does not currently expect such delays to have a material adverse impact on the financial condition of the Company or its long-term operating performance, and while the COVID-19 pandemic has not adversely affected the liquidity position of the Company, the Company cannot give assurances as to the full extent of the impact at this time.

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