What changed in this filing

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Item 1. Business

2023-03-02 compared with 2022-03-03 · 159 added, 131 removed, 678 unchanged (30% of the section changed)

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We are a commercial-stage pharmaceutical company.

Our lead product, TPOXX®

(“oral TPOXX®”), is a U.S.

Food & Drug Administration ("FDA")-approved oral formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. 

Lead Product-TPOXX®

Oral TPOXX®

is a novel, patented drug that is easy to store, transport and administer.

On July 13, 2018, the FDA approved oral TPOXX®

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.

Oral TPOXX®

labeling, approved by the FDA, limits sales of oral TPOXX®

to those for the U.S.

Strategic National Stockpile ("Strategic Stockpile").

The Company has been delivering oral TPOXX®

to the Strategic Stockpile since 2013.

On December 1, 2021, the Company announced that Health Canada approved oral tecovirimat as an extraordinary use drug.

On January 10, 2022, a Marketing Authorisation Application ("MAA") with the European Medicines Agency ("EMA") for oral tecovirimat was approved. The MAA was filed under the centralized application process, which authorized the sale of oral tecovirimat in European Union member states, as well as Norway (which granted separate follow-on approval), Iceland, and Liechtenstein.

The EMA approved label indication covers the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox.

With respect to the regulatory approvals by Health Canada and the EMA, oral tecovirimat represents the same formulation that was approved by the FDA in July 2018 under the brand name TPOXX®.

For the intravenous formulation of TPOXX®

("IV TPOXX®"), SIGA filed a New Drug Application ("NDA") with the FDA on April 30, 2021.

Based on its review of the NDA, the FDA will decide whether to approve IV TPOXX®

and whether to impose any marketing restrictions or require additional post-approval clinical studies.

The Company is targeting the first half of 2022 for completion of this review process.

There can be no assurance that any approval will be granted on a timely basis, if at all.

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.

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.

Procurement Contracts with the U.S.

19C BARDA Contract

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®

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, 2021, 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 $239.7 million of payments are related to exercised options and up to approximately $311.1 million of payments are currently specified as unexercised options.

The $239.7 million of payments related to exercised options includes an option exercised on September 7, 2021 for the manufacture and delivery of approximately $112.6 million of oral TPOXX®.

BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options.

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. 

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("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 advanced development of IV TPOXX®;

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, 2021, the Company has received $11.1 million for the successful delivery of approximately 35,700 courses of oral TPOXX®

to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS and $13.8 million for other base period activities.

IV BDS is expected to be used for the manufacture of 20,000 courses of IV FDP.

The $3.2 million received for the completed manufacture of IV BDS has been recorded as deferred revenue as of December 31, 2021 and December 31, 2020;

such amount is expected to be recognized as revenue when IV TPOXX®

containing such IV BDS is delivered to the Strategic Stockpile or placed in vendor-managed inventory.

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. 

The options that have been exercised to date provide for payments up to approximately $268.9 million.

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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, 2021, the Company has delivered approximately $225.1 million (including the value of raw materials) of oral TPOXX®

to the Strategic Stockpile, of which approximately $112.5 million was delivered in 2021 (including approximately $79.7 million of oral TPOXX®

that was delivered and invoiced in December 2021, for which full payment was received in January 2022);

and $7.3 million has been received or billed for in connection with 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).

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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;

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

and payments of up to approximately $5.6 million for supportive procurement activities.

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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).

If BARDA decides to only exercise IV BDS Options, then the Company would receive payments up to $30.7 million;

alternatively, if BARDA decides to exercise both IV BDS Options and IV FDP Options, then the Company would receive payments up to $76.8 million.

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.

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.

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 940,000 courses of smallpox antiviral treatment would need to be delivered to the U.S.

Government between 2022 and 2024 in order to maintain stockpile levels of unexpired smallpox antiviral treatment during this period.     

1C BARDA Contract  

(2011 BARDA Contract)

On May 13, 2011, the Company signed a contract with BARDA ("1C BARDA Contract" or "2011 BARDA Contract") pursuant to which BARDA agreed to buy from the Company 

1.7 million courses of oral TPOXX®, as well as provide development funding for certain activities.

The 1C BARDA Contract specifies approximately $

508.4 million of payments, of which, as of

December 31, 2021, $

459.8 million had been received by the Company for the manufacture and delivery of oral TPOXX®

45.9 million had been received for certain reimbursements in connection with development and supportive activities.

Approximately $

2.7 million remains eligible to be received in the future for reimbursements of development and supportive activities.

The 1C BARDA Contract expires in December 2024.

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.     

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 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®. 

International Procurement Contracts

Contract with Public Health Agency of Canada

On January 13, 2021, the Public Health Agency of Canada ("PHAC") awarded a contract to Meridian Medical Technologies, Inc. (“Meridian”) (the “Contract”) for the purchase of up to approximately $33 million of oral TPOXX® (tecovirimat) within five years.

In January 2022, PHAC published a proposed amendment in which total procurement of oral TPOXX®

under the Contract would be increased to an amount of up to $38 million, with firm commitments for the cumulative purchase of approximately $23 million of oral TPOXX®

by March 31, 2023;

the remaining courses under the Contract are targeted for delivery after March 31, 2023 and are subject to option exercise by PHAC.

As of December 31, 2021, approximately $10 million of oral TPOXX®

courses had been delivered to and accepted by PHAC.

Such courses were delivered in the first six months of 2021.

The contract award was coordinated between SIGA and Meridian under an international promotion agreement, as amended (the "International Promotion Agreement") that was entered into by the parties on June 3, 2019.

As such, Meridian is the PHAC's counterparty under the Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX®

purchased thereunder. 

Canadian Military Contract

On April 3, 2020, the Company announced that the Canadian Department of National Defence (“CDND”) awarded a contract (the "Canadian Military Contract") to Meridian, pursuant to which the CDND will purchase up to approximately $14 million of oral TPOXX® over four years. 

In the second quarter 2020, CDND purchased approximately $2 million of oral TPOXX®.

In the third quarter of 2021, CDND purchased another approximately $2 million of oral TPOXX®

The remaining purchases are at the option of the CDND.

Meridian is the CDND's counterparty under the Canadian Military Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX®

purchased thereunder. 

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.

International Promotion Agreement

Under the terms of the International Promotion Agreement, Meridian was granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX®

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.

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SIGA’s consent is required for the entry into any sales arrangement pursuant to 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 years in which customer invoiced 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 years in which such net invoiced 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®

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%. 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).

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).

Research Agreements and Grants

The Company has an R&D program for IV TPOXX®.

This program is funded by the 19C BARDA Contract and a separate development contract with BARDA ("IV Formulation R&D Contract").

The IV Formulation R&D Contract has a period of performance that terminates in February 2024.

December 31, 2021, the IV Formulation R&D Contract provided for future aggregate research and development funding of up to approximately 

$0.5 million.

See Note 3 to the consolidated financial statements regarding the 19C BARDA Contract.

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 U.S.

Department of Defense (the "DoD") to support work in pursuit of a potential label expansion for oral TPOXX®

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 $26 million.

The period of performance for this contract, as modified, terminates on April 30, 2024.

December 31, 2021, the PEP Label Expansion R&D Contract provided for future aggregate research and development funding under the award, as modified, of up to 

$23.3 million. 

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.

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

Powdersize, LLC (“Powdersize”);

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

Catalent Pharma Solutions LLC (“Catalent”);

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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 new agreement, SIGA will purchase 100% of its internal and external API requirements for 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.

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(i) September 30, 2023, or (ii) the fulfillment of delivery obligations under the 19C BARDA Contract.

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.

Powdersize, a Lonza Group company, micronizes and tests API for use in oral TPOXX®.

The Company’s agreement with Powdersize was amended on January 11, 2019.

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.

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

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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 has an initial term that ends on March 1, 2022.

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 the agreement has been extended to March 1, 2023. 

The agreement can be terminated earlier than March 1, 2023 under certain conditions.

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 Contracts, the Company has agreed to use the following CMOs:

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

Roquette America, Inc.

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

are terminated.

Thereafter, this agreement automatically renews for two-year increments unless either party provides twelve months’

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.

Corporate Responsibility and Sustainability

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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.

All manufacturers within SIGA’s supply chain, including Grace, Powdersize, 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.

Market for Biological Defense Programs

The market for biodefense countermeasures reflects continued awareness of the threat of global terror and biowarfare activity.

Government is the largest source of development and procurement funding for academic institutions and biopharmaceutical companies conducting biodefense research or developing vaccines, anti-infectives and immunotherapies directed at potential agents of bioterror or biowarfare.

Market for Medical Countermeasures for Biological Threats

The market for medical countermeasures reflects continued awareness of the risks and threats of biological outbreaks, including such outbreaks related to global terror and biowarfare activity.

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 biological and other threats to civilian populations was approximately $2 billion.

In response to the COVID-19 pandemic, Congress has appropriated over $45 billion since the start of the pandemic across four supplemental appropriations for the purposes of developing necessary countermeasures and vaccines, prioritizing platform-based technologies with U.S.-based manufacturing capabilities, the purchase of vaccines, therapeutics, diagnostics, necessary medical supplies, as well as medical surge capacity, and other preparedness and response activities.

While the focus of such appropriations is to support a broad-based response to the COVID-19 pandemic, funds from these appropriations could, depending on the COVID-19 response, be available to support biodefense activities related to the development of new medical countermeasures, building and upgrading of facilities, improvement in surge capacity, and procurement of ancillary medical supplies.

We believe that potential markets for the sale of biodefense countermeasures in addition to the U.S.

Government include:

foreign governments, including both defense and public health agencies;

NGOs and multinational companies, including transportation and security companies;

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, including both public health and defense agencies;

foreign governments, including both public health and defense agencies;

NGOs and multinational companies;

healthcare providers, including hospitals and clinics;

state and local governments, which may be interested in procuring these products to protect, among others, emergency responders, such as police, fire and emergency medical personnel.

At present, oral TPOXX®

is not approved for sale in the U.S.

beyond sales to the U.S.

Government for the purpose of stockpiling and/or usage by the Strategic Stockpile.

The Company would need to meet additional regulatory requirements before sales could be made in the U.S.

beyond the U.S.

We receive cash payments from BARDA on a monthly basis, as services are performed or goods are purchased.

With respect to U.S.

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.

Government and, if canceled, we will not receive funds for additional work under the agreements.

With respect to international government contracts, we receive cash payments based on the terms contained within the International Promotion Agreement with Meridian, under which Meridian collects payments from foreign governments.

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

Our competitors include many major pharmaceutical companies, most of which have financial, technical and marketing resources significantly greater than ours.

Biotechnology and other pharmaceutical competitors in the biodefense space include, but are not limited to, Emergent BioSolutions Inc., Bavarian Nordic AS, and Chimerix, Inc.

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.

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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 biodefense products.

Government with respect to medical countermeasure products.

Human Capital Resources and Research Facilities

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Intellectual Property and Proprietary Rights

SIGA’s commercial success will depend in part on its 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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June 15, 2010

September 4, 2031

United States

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March 23, 2031

United States

ST-246 suspension formulations

September 6, 2022

November 27, 2039

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

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August 2, 2031

Russian Federation

Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus

53 unchanged sentences

July 11, 2034

ST-246 suspension formulations

February 15, 2037

BR 112012023743-8

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July 11, 2034

Rehydration of micronized Tecovirimat monohydrate

August 16, 2022

November 14, 2034

AU 2004249250

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November 14, 2034

AU 20172211295

ST-246 suspension formulations

February 15, 2037

AU 2020202894

Methods of preparing Tecovirimat

August 14, 2033

ARIPO*/Africa

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June 18, 2029

A Patent Term Extension Application is pending for US 7737168, which would change the expiration date from May 3, 2027 to September 4, 2031.

A Patent Term Extension Application is also pending for US 8124643, which would change the expiration date from June 18, 2024 to December 13, 2027.

In the event that both US 7737168 and US 8124643 are found to be eligible for a patent term extension, SIGA would only be able to elect one of the two patents for which the extension is sought and would elect to extend US 7737168.

*African Regional Intellectual Property Organization ("ARIPO") designated contracting states are as follows:

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Intellectuelle ("OAPI") designated contracting states are as follows:

Benin, Burkina Faso, Cameroon, the Central African Republic, Chad, the Congo, Côte d’Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea-Bissau, Mali, Mauritania, the Niger, Senegal, and Togo.

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®

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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 particular 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.

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

was determined under the “Animal Rule.”

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.

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Under this authority, the FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by such agents when appropriate findings are made concerning the nature of the emergency, the availability of adequate and approved alternatives, and the quality of available data concerning the drug candidate under consideration for emergency use.

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.

The centralized procedure is compulsory for medicinal products produced by biotechnology or those medicinal products containing new active substances for specific indications such as the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, viral diseases and designated orphan medicines, and optional for other medicines which are highly innovative.

Under the centralized procedure, a marketing application is submitted to the European Medicines Agency (EMA) where it will be evaluated by the Committee for Medicinal Products for Human Use and a favorable opinion typically results in the grant by the European Commission of a single marketing authorization that is valid for all EU Member States within 67 days of receipt of the opinion.

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.

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®.

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.

Legislation and Regulation Related to Bioterrorism Counteragents and Pandemic Preparedness

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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.

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 that available in the United States such as a procedure similar to the “Animal Rule”

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.

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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