What changed in this filing

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Item 1. Business

2022-03-03 compared with 2021-03-04 · 170 added, 158 removed, 639 unchanged (34% of the section changed)

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

BARDA Contracts-TPOXX®

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®

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.

Procurement Contracts with the U.S.

19C BARDA Contract

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Biomedical Advanced Research and Development Authority ("BARDA") pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX®

Strategic National Stockpile ("Strategic Stockpile"), and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of the intravenous (IV) formulation of TPOXX®

(“IV TPOXX®”).

Additionally, the contract includes funding from BARDA for advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, and procurement activities.

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.

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and payments of approximately $0.6 million for supportive procurement activities.

As of December 31, 2020, the Company had received or billed for $11.1 million for the successful delivery of approximately 35,700 courses of oral TPOXX®

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 manufacture of IV BDS has been recorded as deferred revenue as of December 31, 2020 and December 31, 2019;

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®

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There are exercised options for the following activities:

payments up to $11.2 million for the procurement of raw materials to be used in the manufacture of at least 363,070 courses of oral TPOXX®, payments up to $101.3 million for the delivery of up to 363,070 courses of oral TPOXX®;

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®;

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

As of December 31, 2020, the Company has received the following payments in connection with exercised options:

$11.2 million was received for the procurement of raw materials and such amount was initially recorded as deferred revenue and was recognized as revenue during the year ended December 31, 2020, with deliveries of approximately 363,000 courses, in the aggregate, of oral TPOXX®;

$101.3 million was received in connection with the June, September and October deliveries, in total, of approximately 363,000 courses of 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®.

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There are options for the following activities:

payments of up to $337.7 million for the delivery of up to approximately 1,089,000 courses of oral TPOXX®

payments of up to $225.1 million for the delivery of oral TPOXX®

to the Strategic Stockpile;

payments of up to $76.8 million for the manufacture of up to 192,000 courses of IV FDP, of which up to $30.7 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 $76.8 million for the manufacture of courses of IV FDP, of which up to $30.7 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®;

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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 are 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 one million courses of smallpox antiviral treatment would need to be delivered to the U.S.

Government between 2021 and 2023 in order to maintain stockpile levels of unexpired smallpox antiviral treatment during this period.     

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 pursuant to which BARDA agreed to buy from the Company 1.7 million courses of oral TPOXX®.

Additionally, the Company agreed to contribute to BARDA 300,000 courses at no additional cost to BARDA.

The contract with BARDA (as amended, modified, or supplemented from time to time the "2011 BARDA Contract”) includes a base contract, as modified, (“2011 Base Contract”) as well as options.

The 2011 Base Contract specifies approximately $508.4 million of payments (including exercised options), of which, as of December 31, 2020, $459.8 million has been received by the Company for the manufacture and delivery of 1.7 million courses of oral TPOXX®

and $45.6 million has been received for certain reimbursements in connection with development and supportive activities.

Approximately $3.0 million remains eligible to be received in the future for reimbursements of development and supportive activities.

For courses of oral TPOXX®

that have been physically delivered to the Strategic Stockpile under the 2011 BARDA Contract, there are product replacement obligations, including:

(i) a product replacement obligation in the event that the final version of oral TPOXX®

approved by the FDA was different from any courses of oral TPOXX®

that had been delivered to the Strategic Stockpile (the "FDA Approval Replacement Obligation");

(ii) a product replacement obligation, at no cost to BARDA, in the event that oral TPOXX®

is recalled or deemed to be recalled for any reason;

and (iii) a product replacement obligation in the event that oral TPOXX®

does not meet any specified label claims.

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

for the treatment of smallpox and there is no difference between the approved product and courses in the Strategic Stockpile.

As such, the possibility of the FDA Approval Replacement Obligation resulting in any future replacements of product within the Strategic Stockpile is remote.

The 2011 BARDA Contract includes options.

On July 30, 2018, the 2011 BARDA Contract was modified and BARDA exercised its option relating to FDA approval of the aforementioned 84-month expiry for oral TPOXX®

for which the Company was paid $50.0 million in August 2018.

With the option exercise, the 2011 BARDA Contract was modified so that the 2011 Base Contract increased by $50.0 million.

Remaining options, if all were exercised by BARDA, would result in aggregate payments to the Company of $72.7 million, including up to $58.3 million of funding for development and supportive activities such as work on a post-exposure prophylaxis ("PEP") indication for TPOXX®

and/or $14.4 million of funding for production-related activities related to warm base manufacturing.

BARDA may choose, in its sole discretion not to exercise any or all of the unexercised options.

In 2015, BARDA exercised two options related to extending the indication of the drug to the geriatric and pediatric populations.

The stated value of those exercises was immaterial.

The 2011 BARDA Contract expires in December 2024.

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.

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,” a Pfizer Company) (the “Contract”) for the purchase of up to approximately $33 million of oral TPOXX® (tecovirimat) within five years. The Contract specifies firm commitments for the purchase of approximately $3.4 million of oral TPOXX®

to occur by March 31, 2021 and a cumulative purchase of approximately $17 million of oral TPOXX®

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.

To date, SIGA has not finalized any deliveries yet in connection with this contract.

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.

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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 $2.3 million of oral TPOXX®. 

The remaining purchases are at the option of the CDND, and are expected to occur after regulatory approval of oral TPOXX®

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®

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

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

The fee Meridian retains pursuant to the International Promotion Agreement will be a specified percentage of the collected proceeds of sales of oral TPOXX®

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®

Lead Product-TPOXX®

SIGA believes that TPOXX®

is among the first new small-molecule drugs delivered to the Strategic Stockpile under Project BioShield.

Oral TPOXX®

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

On July 13, 2018, the 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 Strategic Stockpile.

Under the 2011 BARDA Contract, 1.7 million courses of oral TPOXX®

were sold to BARDA and delivered to the Strategic Stockpile between 2013 and 2017.

Courses delivered under the 2011 BARDA Contract have an FDA-approved shelf life of seven years.

Under the 19C BARDA Contract, SIGA can deliver up to 1.7 million courses of TPOXX®

(of which 1,488,000 courses would be oral TPOXX®

and 212,000 courses would be IV TPOXX®) to the Strategic Stockpile, at the option of BARDA.

For IV TPOXX®, SIGA expects to file a new drug application ("NDA") for IV TPOXX®

as early as during the second quarter of 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.

This review process will typically take ten months.

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

As noted above, the FDA approved oral TPOXX®

for the treatment of smallpox.

The Company is currently seeking regulatory approval of oral TPOXX®

in Europe and Canada as well.

In July 2020, the Company filed a Marketing Authorisation Application ("MAA") with the European Medicines Agency ("EMA") for oral tecovirimat, the same formulation that was approved by the FDA in July 2018 under the name TPOXX®. 

The MAA was filed under the centralized application process, which, upon approval, will enable sales and marketing of oral tecovirimat in all EU member states, as well as Norway, Iceland, and Liechtenstein. 

SIGA has filed its application for oral tecovirimat seeking a broader label indication covering the treatment of smallpox, monkeypox, cowpox, and complications from Vaccinia infection.

In December, 2020, the Company filed an application for marketing authorization in Canada for oral tecovirimat, using the same formulation approved by the FDA.

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.

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).

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®

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. 

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.

Manufacturing

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

Albemarle Corporation (“Albemarle”);

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

Powdersize, LLC (“Powdersize”);

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and Packaging Coordinators, LLC ("PCI").

In August 2011, SIGA entered into an agreement with Albemarle.

Such agreement was amended in April 2015 and expired in April 2018.

On October 1, 2018, SIGA entered into a new agreement with Albemarle pursuant to which Albemarle manufactures, tests and supplies active pharmaceutical ingredient (“API”) for use in TPOXX®.

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

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

From and after the later of:

(i) September 30, 2021, or (ii) such time as SIGA has purchased twelve metric tons of API from Albemarle, SIGA will purchase at least 70% of its internal and external API requirements for TPOXX®

from Albemarle until the end of the term of the new agreement (as described below), unless the Company receives an offer to purchase API at a price that Albemarle is unable to match, in which event SIGA will purchase at least 30% of its internal and external API requirements for TPOXX®

from Albemarle until September 30, 2023.

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, 2021, 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.

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

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

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

(ii) if a contract entered into by SIGA for the sale of FDP in an intravenous formulation requires different specifications than those provided for under the agreement and the parties are not able to reach agreement on the necessary changes to the specifications or on pricing;

or (iii) if Albemarle fails to perform any of its obligations under the agreement and does not cure such failure within 30 days of written notice from SIGA.

SIGA is required to pay Albemarle within 45 days of its invoice date.

or (iii) if Grace fails to perform any of its obligations under the agreement and does not cure such failure within 30 days of written notice from SIGA.

SIGA is required to pay Grace within 45 days of its invoice date.

Pricing for API is at a fixed price per kilogram, subject to adjustment for increases in raw material costs and/or general manufacturing costs.

Albemarle is required to deliver API that conforms to specifications outlined in the agreement;

Grace is required to deliver API that conforms to specifications outlined in the agreement;

the Company is not required to pay for API that does not meet specifications.

The Company has 120 days to reject any shipments that do not meet such specifications or are damaged.

In addition to receiving payments for API deliveries, Albemarle is also paid for related services, such as stability testing.

The Company’s agreement with Albemarle is currently scheduled to expire upon the earlier of:

In addition to receiving payments for API deliveries, Grace is also paid for related services, such as stability testing.

The Company’s agreement with Grace is currently scheduled to expire upon the earlier of:

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

Thereafter, the agreement shall renew for successive one-year renewal terms until either the Company or Albemarle provides notice of non-renewal at least 90 days prior to the expiration date of a term.

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®.

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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 has an initial term that ends on June 28, 2021.

Thereafter, this agreement automatically renews for three years unless either party provides six months' notice of its desire to terminate the agreement prior to the expiration of the term;

as of the filing date, the Company has not provided nor received notice of termination. During the term of the agreement, SIGA will purchase all of its requirements for bulk product under the 19C BARDA contract from Catalent.

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®.

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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.

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Patheon Manufacturing Services LLC (“Patheon”);

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

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.

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

As noted above, PCI is expected to provide packaging services for IV TPOXX®.

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

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 Albemarle, Powdersize, 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 the scale is too small to report separately their impact.

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.

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

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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.

Government spending on biodefense programs includes development funding awarded by the National Institute of Allergy and Infectious Diseases, BARDA and the Department of Defense (“DoD”), and procurement of countermeasures by BARDA, the Strategic Stockpile and the DoD.

For the fiscal year ending September 30, 2021, the budget for the U.S.

Department of Health and Human Services provides an annual appropriation of approximately $2.0 billion for activities related to advanced development and procurement of medical countermeasures for biological and other threats to civilian populations.

In response to the COVID-19 pandemic, Congress has appropriated over $45 billion over the past year 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.

Government's fiscal year ended September 30, 2021, 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.

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healthcare providers, including hospitals and clinics;

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

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®

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

beyond the U.S Government.

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.

As of December 31, 2020, the IV Formulation R&D Contract provides for future aggregate research and development funding of up to approximately $2.1 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 initial available funding 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 May 2020, the DoD increased the scope and the contract value to a total of $26 million with current available funding of $23 million.

As of December 31, 2020, the PEP Label Expansion R&D Contract provides for future aggregate research and development funding under the award, as modified, of up to approximately $22.4 million.

The period of performance for this contract, as modified, terminates on July 31, 2025.

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, we may not be eligible to receive all available funds.

beyond the U.S.

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

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

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

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.

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Human Capital Resources and Research Facilities

As of February 16, 2021, we had 42  

full-time employees.

As of February 16, 2022, we had 39 full-time employees.

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

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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.

This lease has one remaining renewal option for an additional three years.

Intellectual Property and Proprietary Rights

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patent portfolio has seven patent families consisting of 28 U.S.

utility patents, 86 issued foreign patents, three U.S.

utility patents, 97 issued foreign patents, two U.S.

utility patent applications, and 24 foreign patent applications.

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November 14, 2034

United States

Certain polymorphs of ST-246 and pharmaceutical compositions containing the polymorphs

March 2, 2021

March 23, 2031

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

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March 23, 2031

SG 10201506031U

ST-246 liquid formulations and methods

June 11, 2021

August 2, 2031

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

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November 14, 2034

Amorphous Tecovirimat preparation

February 29, 2021

July 11, 2034

BR 112012023743-8

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March 23, 2031

BR 112013002646-4

Liquid Pharmaceutical formulations containing ST-246

January 4, 2022

August 2, 2031

CN 2011800245893

34 unchanged sentences

March 23, 2031

Amorphous Tecovirimat preparation

August 31, 2021

July 11, 2034

AU 2004249250

66 unchanged sentences

March 23, 2031

Compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases

December 1, 2020

April 23, 2027

Amorphous Tecovirimat preparation

March 1, 2021

July 11, 2034

Rehydration of micronized Tecovirimat monohydrate

September 1, 2021

November 14, 2034

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

37 unchanged sentences

July 11, 2034

Rehydration of micronized Tecovirimat monohydrate

January 6, 2021

November 14, 2034

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

31 unchanged sentences

July 11, 2034

Rehydration of micronized Tecovirimat monohydrate

January 6, 2021

November 14, 2034

United Kingdom

22 unchanged sentences

July 11, 2034

United Kingdom

Rehydration of micronized Tecovirimat monohydrate

January 6, 2021

November 14, 2034

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

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March 23, 2031

Liquid Pharmaceutical formulations containing ST-246

November 12, 2021

October 28, 2033

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

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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.

* ARIPO has 19 member African States as follows:

Botswana, The Gambia, Ghana, Kenya, Lesotho, Malawi, Mozambique, Namibia, Sierra Leone, Liberia, Rwanda, Sao Tome and Principe, Somalia, Sudan, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe.

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

Botswana, Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Sierra Leone, Sudan, Swaziland, Tanzania, Uganda, Zambia, and Zimbabwe.

Organisation Africaine de la Propriété

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

Benin, Burkina Faso, Cameroon, the Central African Republic, Chad, the Congo, 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 33 patent applications currently pending with respect to various compositions of TPOXX®, methods of manufacturing, methods of treatment, and dosage forms.

We hold 26 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.

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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 ex-U.S.

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

in light of native language and other jurisdictional considerations.

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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 may apply to us will vary depending on the nature of any particular product.

Virtually all of our potential pharmaceutical products will require regulatory approval by governmental agencies prior to non-governmental commercialization.

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 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.

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 is complex and requires 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.

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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 the U.S.

Department of Health and Human Services (“HHS”) to commit funds to countermeasure projects.

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.

Prior to the award of the BARDA Contract in May 2011, the Secretary of HHS concluded that TPOXX®

would qualify within eight years for approval by the FDA for therapeutic use against smallpox.

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

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of a future public health emergency.

Since 2007, the Secretary of HHS has issued eight 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 was amended in 2015 to extend protection for smallpox and other countermeasures from December 31, 2015 to December 31, 2022.

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 2015 to extend protection from December 31, 2015 to December 31, 2022.

Foreign Regulation

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Availability of Reports and Other Information

We file annual, quarterly, and current reports, proxy statements, and other documents with the SEC under the Securities Exchange Act of 1934.

The public may read and copy any material that we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C.

The public may obtain information on the operation of the Public Reference Room by calling the SEC at (800) SEC-0330.

Also, 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.

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.

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.

The public can obtain any document that we file with or furnish to the SEC at www.sec.gov .

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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 “Investor Relations”

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:

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Code of Ethics and Business Conduct;

Procedure for Sending Communications to the Board of Directors;

Procedures for Security Holder Submission of Nominating Recommendations;

Policy on Confidentiality of Information and Securities Trading;

Conflict of Interest Policy.

To review these documents, access www.siga.com and click on “Investor Relations”

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

and “Corporate Governance.”

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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