What changed in this filing

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Item 1. Business

2024-03-12 compared with 2023-03-02 · 210 added, 241 removed, 596 unchanged (43% of the section changed)

SIGA Technologies, Inc.

is referred to throughout this report as “SIGA,”

“the Company,”

“we”

or “us.”

is referred to throughout this report as “SIGA,” “the Company,” “we” or “us.”

We are a commercial-stage pharmaceutical company.

The Company sells its lead product, TPOXX® (“oral TPOXX®,” also known as "tecovirimat" in certain international markets), to the U.S.

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.

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®

Additionally, the Company sells the intravenous formulation of TPOXX® ("IV TPOXX®") to the U.S.

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.

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 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.

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.

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®.

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. 

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.

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. 

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. 

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.

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.

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.

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 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.

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®.

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.

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.

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.

As of December 31, 2023, there were five randomized, placebo-controlled clinical trials enrolling patients, when available, in locations including the United States, United Kingdom, the Democratic Republic of Congo ("DRC"), South America and Europe.

These randomized clinical trials are enrolling patients to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease.

The 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.

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.

Procurement Contracts with the U.S.

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®.

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.

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. 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. 

On September 10, 2018, the Company entered into a contract with the U.S.

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®.

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).

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.

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.

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.

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 $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 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.

IV BDS has been used for the manufacture of courses of IV FDP. 

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.

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.

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®.

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®.

Unexercised options specify potential payments up to approximately $281.9 million in total (if all such options are exercised).

payments up to $337.7 million for the manufacture and delivery of up to 1.1 million courses of oral TPOXX®;

payments up to $51.2 million for the manufacture of courses of IV FDP, of which $20.4 million of payments relate to the manufacture of IV BDS to be used in the manufacture of IV FDP;

payments of up to approximately $3.6 million to fund post-marketing activities for IV TPOXX®;

and payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX®.

As of December 31, 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®.

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.

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.

The options related to IV TPOXX®

are divided into two primary manufacturing steps.

There are options related to the manufacture of bulk drug substance (“IV BDS Options”), and there are corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”).

payments of up to $112.5 million for the delivery of oral TPOXX® to the Strategic Stockpile;

and payments of up to $25.6 million for the manufacture of courses of IV FDP, of which up to $10.2 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP.

The options related to IV TPOXX® are divided into two primary manufacturing steps.

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®.

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®.

BARDA has the sole discretion as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option).

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. 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.

To date, BARDA has exercised two of the three IV BDS options and two of the three IV FDP options.

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.

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.

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 request for proposal that preceded the award of the 19C BARDA Contract indicated that the expected purpose of the contract was to maintain the level of smallpox antiviral preparedness in the Strategic Stockpile. 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.     

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 request for proposal that preceded the award of the 19C BARDA Contract indicated that the expected purpose of the contract was to maintain the level of smallpox antiviral preparedness in the Strategic Stockpile.

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.

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"). 

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®. 

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 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 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").

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®.

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 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 #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®.

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.

In February 2024, DoD Contract #2 was amended and approximately $1 million of oral TPOXX® was ordered by the DoD.

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. 

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®.

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.

(“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). 

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.

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. 

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.

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.

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.

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.

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.

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.

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.

("Meridian") is the counterparty to international contracts under which orders are placed for the purchase 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 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.

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.

SIGA retains ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retains sales and marketing rights with respect to oral TPOXX®.

SIGA’s consent is required for the entry into any sales arrangement pursuant to the International Promotion Agreement.

Under the 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.

SIGA retains ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retains sales and marketing rights with respect to oral TPOXX®.

SIGA’s consent is required for the entry into any sales arrangement pursuant to the International Promotion Agreement.

Sales to international customers pursuant to the International Promotion Agreement are invoiced and collected by Meridian, and such collections are remitted, less Meridian's fees, to the Company under a quarterly process specified in the International Promotion Agreement.

The fee Meridian retains pursuant to the International Promotion Agreement is a specified percentage of the collected proceeds of sales of oral TPOXX®, net of certain expenses, for calendar years in which customer collected amounts net of such expenses are less than or equal to a specified threshold, and a higher specified percentage of such collected net proceeds for calendar years in which such net collected amounts exceed the specified threshold.

Taking into account Meridian’s fee and manufacturing costs of oral TPOXX®, it is currently estimated by the Company that international sales of oral TPOXX®

each year will have a contribution margin (as expressed as a percentage of product sales, and before any consideration of expenses not directly related to manufacturing or Meridian activities) of between approximately 65% and 80%, depending on the international sales levels each year. 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).

The fee Meridian retains pursuant to the International Promotion Agreement is a specified percentage of the collected proceeds of sales of oral TPOXX®, net of certain expenses, for calendar years in which customer collected amounts net of such expenses are less than or equal to a specified threshold, and a higher specified percentage of such collected net proceeds for calendar years in which such net collected amounts exceed the specified threshold.

Taking into account Meridian’s fee and manufacturing costs of oral TPOXX®, it is currently estimated by the Company that international sales of oral TPOXX® each year will have a contribution margin (as expressed as a percentage of product sales, and before any consideration of expenses not directly related to manufacturing or Meridian activities) of between approximately 65% and 80%, depending on the international sales levels each year.

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).

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").

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. 

In July 2019, the Company was awarded a multi-year research contract ultimately valued at approximately $27 million from the DoD to support work in pursuit of a potential label expansion for oral TPOXX® that would include post-exposure prophylaxis ("PEP") of smallpox (such work known as the "PEP Label Expansion Program" and the contract referred to as the "PEP Label Expansion R&D Contract").

As of 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.

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.

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®.

SIGA relies on and uses third parties known as Contract Manufacturing Organizations (“CMOs”) to procure commercial raw materials and supplies, and to manufacture TPOXX®.

SIGA's CMOs apply methods and controls in facilities that are used for manufacturing, processing, packaging, testing, analyzing and holding pharmaceuticals which conform to current good manufacturing practices (“cGMP”), the standard set by the FDA for manufacture and storage of pharmaceuticals intended for human use.

Oral TPOXX®:

For the manufacture of oral TPOXX®, the Company uses the following CMOs:

Grace and Company (“Grace”), who acquired the assets of Albemarle's Fine Chemistry Services Business in 2021;

Microsize, formerly known as Powdersize, LLC and renamed following a change of control transaction;

Catalent Pharma Solutions LLC (“Catalent”);

SIGA does not have a manufacturing infrastructure and does not intend to develop one for the manufacture of TPOXX®.

SIGA relies on and uses third parties known as Contract Manufacturing Organizations (“CMOs”) to procure commercial raw materials and supplies, and to manufacture TPOXX®.

For the manufacture of oral TPOXX®, the Company uses the following CMOs:

Grace and Company (“Grace”), who acquired the assets of Albemarle's Fine Chemistry Services Business in 2021;

Microsize, formerly known as Powdersize, LLC and renamed following a change of control transaction;

Catalent Pharma Solutions LLC (“Catalent”);

and Packaging Coordinators, LLC ("PCI").

SIGA has had manufacturing agreements with Grace and a predecessor owner (Albemarle) since 2011. 

Pursuant to the current agreement with Grace, which was put in place in 2018 when Albemarle was the owner of the operations that provide services to SIGA, Grace manufactures, tests and supplies active pharmaceutical ingredient (“API”) for use in TPOXX®.

The agreement provides that, during the term of the current agreement, SIGA was required to purchase 100% of its internal and external API requirements for TPOXX®

from Grace until the later of (i) September 30, 2021 and (ii) such time as SIGA has purchased 12 metric tons of API from Grace under the agreement.

SIGA has had manufacturing agreements with Grace and a predecessor owner (Albemarle) since 2011.

Pursuant to the current agreement with Grace, which was put in place in 2018 when Albemarle was the owner of the operations that provide services to SIGA, Grace manufactures, tests and supplies active pharmaceutical ingredient (“API”) for use in TPOXX®.

The agreement provides that, during the term of the current agreement, SIGA was required to purchase 100% of its internal and external API requirements for TPOXX® from Grace until the later of (i) September 30, 2021 and (ii) such time as SIGA has purchased 12 metric tons of API from Grace under the agreement.

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 September 30, 2023.

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.

There is no minimum amount of kilograms of API that must be used or acquired by SIGA.

The following events are excluded from the “100% API”

(i) if a contract entered into by SIGA for the sale of final drug product (“FDP”) requires that the product used as the API for such FDP be manufactured outside the U.S.

The following events are excluded from the “100% API” requirement:

(i) if a contract entered into by SIGA for the sale of final drug product (“FDP”) requires that the product used as the API for such FDP be manufactured outside the U.S.

and Grace is unwilling or unable to subcontract such manufacture to a party or parties that meet the terms of the agreement;

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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:

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.

As such, since the delivery obligations under the 19C BARDA Contract have not been fulfilled yet, the contract term continues.

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.

Microsize micronizes and tests API for use in oral TPOXX®.

The Company’s agreement with Microsize's predecessor was amended on January 11, 2019.

On September 30, 2023, the contract term automatically renewed for a one-year term.

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.

Microsize micronizes and tests API for use in oral TPOXX®.

The Company’s agreement with Microsize's predecessor was amended on January 11, 2019.

The amended term ends on the tenth anniversary of the amendment date.

Catalent granulates, encapsulates, and tests oral TPOXX®.

In addition, Catalent provides services related to commercial stability testing of drug product and preparation for tabulated stability and trend analysis for each time point.

The Company’s agreement with Catalent had an initial term that ended on June 28, 2021.

Thereafter, this agreement became subject to automatic renewal for three years unless either party provided six months' notice of its desire to terminate the agreement prior to the expiration of the term. 

The Company did not provide notice nor receive notice of termination. 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®.

The Company’s agreement with PCI had an initial term that ended on March 1, 2022.

The Company’s agreement with Catalent had an initial term that ended on June 28, 2021.

Thereafter, this agreement became subject to automatic renewal for three years unless either party provided six months' notice of its desire to terminate the agreement prior to the expiration of the term.

The Company did not provide notice nor receive notice of termination.

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®.

The Company’s agreement with PCI had an initial term that ended on March 1, 2022.

Thereafter, this agreement automatically renews for successive one-year periods unless either party provides 120 days' notice of its desire to terminate the agreement prior to the expiration of the term.

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.

Intravenous (IV) formulation of TPOXX®:

For the manufacture of IV TPOXX®

under the BARDA Contract, the Company has agreed to use the following CMOs:

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.

Intravenous (IV) formulation of TPOXX®:

For the manufacture of IV TPOXX® under the BARDA Contract, the Company has agreed to use the following CMOs:

Roquette America, Inc.

(“Roquette”);

Patheon Manufacturing Services LLC (“Patheon”);

Roquette provides an excipient used in the manufacturing of IV TPOXX®.

(“Roquette”);

Patheon Manufacturing Services LLC (“Patheon”);

Roquette provides an excipient used in the manufacturing of IV TPOXX®.

The Company's agreement with Roquette has no minimum amount of manufacturing services that must be used.

The Company’s agreement with Roquette has an initial term that ends on December 31, 2023.

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®.

SIGA agreed that Patheon will be entitled to manufacture at least 80% of IV TPOXX®

offered for sale by SIGA during the first three years of the agreement, provided Patheon adheres to reasonable manufacturing standards.

The Company’s agreement with Roquette had an initial term that ended on December 31, 2023.

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®.

SIGA agreed that Patheon will be entitled to manufacture at least 80% of IV TPOXX® offered for sale by SIGA during the first three years of the agreement, provided Patheon adheres to reasonable manufacturing standards.

Thereafter, the manufacturing percentage will be as mutually agreed upon by the parties.

The Company’s agreement with Patheon has an initial term that ends on the later of:

December 31, 2022 or, such date as all government contracts related to IV TPOXX®

are terminated. As such, since the Company continues to have active government contracts related to IV TPOXX®, the contract term continues.

At the end of the above mentioned contract term, this agreement automatically renews for two-year increments unless either party provides twelve months’

notice of its desire to terminate the agreement prior to the expiration of the term.

As noted above, PCI provides packaging services for IV TPOXX®.

The Company’s agreement with Patheon has an initial term that ends on the later of:

December 31, 2022 or, such date as all government contracts related to IV TPOXX® are terminated.

As such, since the Company continues to have active government contracts related to IV TPOXX®, the contract term continues.

At the end of the above mentioned contract term, this agreement automatically renews for two-year increments unless either party provides twelve months’ notice of its desire to terminate the agreement prior to the expiration of the term.

As noted above, PCI provides packaging services for IV TPOXX®.

Grace provides the API used in manufacturing of the intravenous formulation.

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SIGA seeks to promote a sustainable environment by tracking the involvement of its manufacturing supply chain in initiatives and organizations that prioritize a sustainable environment.

Almost all manufacturers within SIGA’s supply chain, including Grace, Catalent, PCI, Patheon and Roquette, maintain corporate social responsibility and/or sustainability programs and publicly report on those programs.

Almost all manufacturers within SIGA’s supply chain, including Grace, Catalent, PCI, Patheon and Roquette, maintain corporate social responsibility and/or sustainability programs and publicly report on those programs.

SIGA also pursues such policies within its own corporate environment, although SIGA's corporate scale is relatively too small to report separately their impact.

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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.

Government's fiscal year ended September 30, 2022, the budget for annual spending by the U.S.

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.

We believe that potential markets for the sale of medical countermeasures include:

Government's fiscal year ended September 30, 2023, the budget for annual spending by the U.S.

We believe that potential markets for the sale of medical countermeasures include:

government, including both public health and defense agencies;

foreign governments, including both public health and defense agencies;

foreign governments, including both public health and defense agencies;

NGOs and multinational companies;

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With respect to U.S.

government contracts, we receive cash payments on a monthly basis, as services are performed or goods are purchased.

government contracts, we receive cash payments on a monthly basis, as services are performed or goods are purchased.

Amounts under contract and grant agreements are not guaranteed and can be canceled at any time for reasons such as non-performance or convenience of the U.S.

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The biotechnology and pharmaceutical industries are characterized by rapidly evolving technology and intense competition.

Our current and potential competitors include many major pharmaceutical companies, many of which have significant financial, technical and marketing resources.

Biotechnology and other pharmaceutical competitors in the medical countermeasure sector include, but are not limited to, Emergent BioSolutions Inc.

and Bavarian Nordic A/S.

Our current and potential competitors include many major pharmaceutical companies, many of which have significant financial, technical and marketing resources.

Biotechnology and other pharmaceutical competitors in the medical countermeasure sector include, but are not limited to, Emergent BioSolutions Inc.

and Bavarian Nordic A/S.

Academic institutions, governmental agencies and other public and private research organizations are also conducting research activities and seeking patent protection and may commercialize products on their own or through joint ventures.

faces significant competition for government funding for both development and procurement of medical countermeasures for biological, chemical, radiological and nuclear threats, diagnostic testing systems, and other emergency preparedness countermeasures.

TPOXX® faces significant competition for government funding for both development and procurement of medical countermeasures for biological, chemical, radiological and nuclear threats, diagnostic testing systems, and other emergency preparedness countermeasures.

Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects, are more convenient or are less expensive than products that we may develop.

In addition, 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.

Government with respect to medical countermeasure products.

Human Capital Resources and Research Facilities

As of February 15, 2024, we had 45 full-time employees.

None of our employees are covered by a collective bargaining agreement, and we consider our employee relations to be satisfactory. 

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants with the overall goal of having an employee base that embraces teamwork and shares a focus for using each person’s individual skills, experience and expertise in order to develop and maximize the value of corporate assets, and achieve long-term revenue and earnings growth.

None of our employees are covered by a collective bargaining agreement, and we consider our employee relations to be satisfactory.

Our research and development facilities are located in Corvallis, Oregon, where we lease approximately 10,276 square feet under a lease agreement that commenced on January 1, 2018 and which expires in December 2024.

Intellectual Property and Proprietary Rights

An important element of SIGA’s business development activities involves the Company's ability to obtain and maintain patent and other intellectual property protection in the U.S.

An important element of SIGA’s business development activities involves the Company's ability to obtain and maintain patent and other intellectual property protection in the U.S.

and the rest of the world for its proprietary technologies, drug targets, and potential products and to preserve its trade secrets.

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SIGA also relies upon trade secret protection for its confidential and proprietary information.

No assurance can be given that other companies will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to SIGA’s trade secrets or that SIGA can meaningfully protect its trade secrets.

SIGA exclusively owns its key patent portfolios, which relate to its leading drug product, TPOXX®

(also known as ST-246, tecovirimat).

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.

SIGA exclusively owns its key patent portfolios, which relate to its leading drug product, TPOXX® (also known as ST-246, tecovirimat).

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.

Patent Number

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November 14, 2034

US 10576165

United States

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August 2, 2031

US 10864282

United States

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August 2, 2031

US 10662155

United States

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August 14, 2033

US 10716759

United States

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November 27, 2039

United States

ST-246 suspension formulations

October 10, 2023

February 15, 2037

Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs

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February 15, 2037

ST-246 suspension formulations

June 16, 2023

February 15, 2037

BR 112012023743-8

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November 14, 2034

CN 202010101449

Methods of preparing Tecovirimat

June 20, 2023

August 14, 2033

Use of ST-246 to treat orthopoxvirus infection, pharmaceutical compositions containing ST-246 and composition of matter for the ST-246 compound

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November 14, 2034

Methods of preparing Tecovirimat

January 24, 2023

August 14, 2033

AU 2004249250

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November 14, 2034

Rehydration of micronized Tecovirimat monohydrate

April 3, 2023

November 14, 2034

ST-246 suspension formulations

February 15, 2037

Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases

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November 14, 2034

Amorphous Tecovirimat preparation

December 13, 2023

July 11, 2034

Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases

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November 14, 2034

Amorphous Tecovirimat preparation

December 13, 2023

July 11, 2034

United Kingdom

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November 14, 2034

United Kingdom

Amorphous Tecovirimat preparation

December 13, 2023

July 11, 2034

Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs

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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.

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.

Expiration dates for pending patent applications, if granted, will fall between 2031 and 2037.

^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.

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.

Expiration dates for pending patent applications, if granted, will fall between 2031 and 2037.

FDA regulations require that patented drugs be sold under brand names that comply with various regulations.

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SIGA may expend substantial funds in developing and securing rights to adequate brand names for our products.

SIGA currently has proprietary trademark rights in SIGA®, TPOXX®

and other brands used by us in the United States and certain foreign countries, but we may have to develop additional trademark rights in order to comply with regulatory requirements.

SIGA currently has proprietary trademark rights in SIGA®, TPOXX® and other brands used by us in the United States and certain foreign countries, but we may have to develop additional trademark rights in order to comply with regulatory requirements.

SIGA may need to pursue different names and trademarks outside of the U.S.

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Regulation by governmental authorities in the United States and other countries is a significant factor in the manufacture and marketing of any biopharmaceutical product that we may develop.

The nature and the extent to which such regulations apply to us vary depending on the nature of each product. In particular, human therapeutic products are subject to rigorous pre-clinical and clinical testing and other approval procedures by the FDA and similar health authorities in foreign countries.

The nature and the extent to which such regulations apply to us vary depending on the nature of each product.

In particular, human therapeutic products are subject to rigorous pre-clinical and clinical testing and other approval procedures by the FDA and similar health authorities in foreign countries.

Various federal statutes and regulations also govern or regulate the manufacturing, safety, labeling, storage, recordkeeping and marketing of such products.

The process of obtaining these approvals and the subsequent compliance with appropriate federal and foreign statutes and regulations are complex and require expertise and the expenditure of substantial resources.

The process of obtaining these approvals and the subsequent compliance with appropriate federal and foreign statutes and regulations are complex and require expertise and the expenditure of substantial resources.

In order to test clinically, and to manufacture and market products for diagnostic or therapeutic use, a company must comply with mandatory procedures and safety standards established by the FDA and comparable agencies in foreign countries.

Before beginning human clinical testing of a potential new drug in the United States, a company must file an Investigational New Drug ("IND") application and receive clearance from the FDA.

An IND application is a summary of the pre-clinical studies that were conducted to characterize the drug, including toxicity and safety studies, information on the drug’s composition and the manufacturing and quality control procedures used to produce the drug, as well as a discussion of the human clinical studies that are being proposed to evaluate the safety and efficacy of the product.

Before beginning human clinical testing of a potential new drug in the United States, a company must file an Investigational New Drug ("IND") application and receive clearance from the FDA.

The pre-marketing clinical program required for approval by the FDA for a new drug typically involves a time-consuming and costly three-phase process.

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In some circumstances, a new formulation of an approved product may be reviewed through a supplemental NDA process which relies in part on the prior approval of the initial formulation.

The FDA amended its regulations, effective June 30, 2002, to include the “Animal Rule”

in circumstances that would permit the typical clinical testing regime to approve certain new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear agents not otherwise naturally present for use in humans based on evidence of safety in healthy subjects and evidence of effectiveness derived only from appropriate animal studies and any additional supporting data.

The FDA has indicated that approval for therapeutic use of TPOXX®

for smallpox was determined under the “Animal Rule.”

Once the product is approved for sale, FDA regulations govern the manufacturing and marketing activities, and a post-marketing testing and surveillance program may be required to monitor a product’s usage and effects.

The FDA amended its regulations, effective June 30, 2002, to include the “Animal Rule” in circumstances that would permit the typical clinical testing regime to approve certain new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear agents not otherwise naturally present for use in humans based on evidence of safety in healthy subjects and evidence of effectiveness derived only from appropriate animal studies and any additional supporting data.

The FDA has indicated that approval for therapeutic use of TPOXX® for smallpox was determined under the “Animal Rule.”

Product approvals may be withdrawn if compliance with regulatory standards is not maintained.

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FDA regulations also make available an alternative regulatory mechanism that may lead to use of the product under limited circumstances.

The Emergency Use Authorization (“EUA”) authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological and nuclear agents that may be used to attack the American people or the U.S.

armed forces.

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In addition to regulations in the United States, we are subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our products.

Whether or not we obtain FDA approval for a product, we must obtain approval by the comparable regulatory authorities of foreign countries or economic areas, such as the European Union (“EU”) and the United Kingdom (UK), before we may commence clinical trials or market products in those countries or areas.

The approval process and requirements governing the conduct of clinical trials, product authorization, pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval. 

Under EU regulatory systems, a company may submit marketing authorization applications either under a centralized or decentralized procedure.

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The initial marketing authorization is valid for five years, but once renewed is usually valid for an unlimited period.

The decentralized procedure provides for approval by one or more “concerned”

member states based on an assessment of an application performed by one member state, known as the “reference”

member state.

The decentralized procedure provides for approval by one or more “concerned” member states based on an assessment of an application performed by one member state, known as the “reference” member state.

Under the decentralized approval procedure, an applicant submits an application, or dossier, and related materials to the reference member state and concerned member states.

The reference member state prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application.

Within 90 days of receiving the reference member state’s assessment report, each concerned member state must decide whether to approve the assessment report and related materials.

If a member state does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding on all member states. On January 10, 2022, the EMA approved SIGA’s Marketing Authorisation Application (MAA) for oral tecovirimat, the same formulation that was approved by the FDA in July 2018 under the brand name TPOXX®.

Within 90 days of receiving the reference member state’s assessment report, each concerned member state must decide whether to approve the assessment report and related materials.

If a member state does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding on all member states.

On January 10, 2022, the EMA approved SIGA’s Marketing Authorisation Application (MAA) for oral tecovirimat, the same formulation that was approved by the FDA in July 2018 under the brand name TPOXX®.

The EMA approval includes labeling for oral tecovirimat indicating its use for the treatment of smallpox, mpox, cowpox, and vaccinia complications following vaccination against smallpox.

The MAA was filed under the centralized application process, which, upon approval, enables sales, including procurement for stockpiling, of oral tecovirimat in all European Union (EU) member states, as well as Norway, Iceland, and Liechtenstein.

The United Kingdom left the European Union on January 31, 2020 (commonly referred to as “Brexit”), with a transitional period that expired on December 31, 2020.

The United Kingdom and the European Union entered into a trade agreement known as the Trade and Cooperation Agreement, which went into effect on January 1, 2021.

On July 8, 2022, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) approved oral tecovirimat for the treatment of smallpox, mpox, cowpox, and vaccinia complications following vaccination against smallpox in adults and children with a body weight of at least 13kg.

Since the regulatory framework in the United Kingdom covering the quality, safety and efficacy of pharmaceutical products, clinical trials, marketing authorization, commercial sales and distribution of medicinal products is derived from EU Directives and Regulations, Brexit could materially impact the future regulatory regime which applies to products and the approval of other product candidates in the United Kingdom.

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Project BioShield

Project BioShield and related 2006 federal legislation provide procedures for biodefense-related procurement and awarding of research grants, making it easier for HHS to commit funds to countermeasure projects.

Project BioShield provides alternative procedures under the Federal Acquisition Regulation, the general rubric for acquisition of goods and services by the U.S.

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there is no adequate alternative to a product that is approved and available.

Although this provision permits the Secretary of HHS to circumvent FDA approval (entirely, or in part) for procurement and use, its use in this manner would likely be limited to rare circumstances. 

Public Readiness and Emergency Preparedness Act

The Public Readiness and Emergency Preparedness Act (the "PREP Act") provides immunity for manufacturers from claims under state or federal law for “loss”

arising out of the administration or use of a “covered countermeasure”

in the United States.

However, injured persons may still bring a suit for “willful misconduct”

against the manufacturer under some circumstances.

“Covered countermeasures”

include security countermeasures and “qualified pandemic or epidemic products,”

including products intended to diagnose or treat pandemic or epidemic disease, as well as treatments intended to address conditions caused by such products.

For these immunities to apply, the Secretary of HHS must issue a declaration in cases of public health emergency or “credible risk”

of a future public health emergency.

Since 2007, the Secretary of HHS has issued nine declarations under the PREP Act to protect from liability countermeasures that are necessary to prepare the nation for potential pandemics or epidemics, including a declaration on October 10, 2008 that provides immunity from tort liability as it relates to smallpox. The PREP Act Declaration for smallpox countermeasures was amended by the Secretary of HHS in 2022 to emphasize that it covers mpox virus, add qualified persons to administer vaccines and therapeutics to address the current public health emergency caused by the 2022 outbreak of mpox cases and the risk of future public health threats arising from orthopoxviruses, and to extend protection from December 31, 2022 to December 31, 2032.

The Public Readiness and Emergency Preparedness Act (the "PREP Act") provides immunity for manufacturers from claims under state or federal law for “loss” arising out of the administration or use of a “covered countermeasure” in the United States.

However, injured persons may still bring a suit for “willful misconduct” against the manufacturer under some circumstances.

“Covered countermeasures” include security countermeasures and “qualified pandemic or epidemic products,” including products intended to diagnose or treat pandemic or epidemic disease, as well as treatments intended to address conditions caused by such products.

For these immunities to apply, the Secretary of HHS must issue a declaration in cases of public health emergency or “credible risk” of a future public health emergency.

The PREP Act Declaration for smallpox countermeasures was amended by the Secretary of HHS in 2022 to emphasize that it covers mpox virus, add qualified persons to administer vaccines and therapeutics to address the current public health emergency caused by the 2022 outbreak of mpox cases and the risk of future public health threats arising from orthopoxviruses, and to extend protection from December 31, 2022 to December 31, 2032.

Foreign Regulation

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The requirements governing the conduct of clinical trials, marketing authorization, pricing and reimbursement vary from country to country.

Certain foreign jurisdictions, including the European Union and Canada, have adopted certain biodefense-specific regulations akin to those available in the United States such as a procedure similar to the “Animal Rule”

promulgated by the FDA for review and potential approval of biodefense products.

Regulations Regarding Government Contracting

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We file annual, quarterly, and current reports, proxy statements, and other documents with the U.S.

Securities and Exchange Commission ("SEC") under the Exchange Act.

Securities and Exchange Commission ("SEC") under the Exchange Act.

The SEC maintains an Internet website that contains reports, proxy and information statements, and other information regarding issuers, including us, that file electronically with the SEC.

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Copies of each of our filings with the SEC on Form 10-K, Form 10-Q, and Form 8-K, and all amendments to those reports, can be viewed and downloaded free of charge as soon as reasonably practicable after the reports and amendments are electronically filed with or furnished to the SEC.

To view the reports, access www.siga.com, click on “Investors”

and “Financial Information.”

The information contained on the websites referenced in this Form 10-K is not incorporated by reference into this filing.

 The following corporate governance related documents are also available on our website:

To view the reports, access www.siga.com, click on “Investors” and “Financial Information.” The information contained on the websites referenced in this Form 10-K is not incorporated by reference into this filing.

The following corporate governance related documents are also available on our website:

Audit Committee Charter;

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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.

To review these documents, access www.siga.com and click on “Investors” and “Corporate Governance.”

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business