What changed in this filing

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Item 1. Business

2025-03-11 compared with 2024-03-12 · 99 added, 180 removed, 626 unchanged (31% of the section changed)

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We are a commercial-stage pharmaceutical company.

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

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

Government and international governments (including government affiliated entities).

In certain international markets, the Company may sell TPOXX® through a distributor.

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

TPOXX® is an oral formulation antiviral drug for the treatment of human smallpox disease caused by variola virus.

On July 13, 2018, the United States Food & Drug Administration (“FDA”) approved oral TPOXX® for the treatment of smallpox.

TPOXX® is an antiviral drug for the treatment of human smallpox disease caused by variola virus.

On July 13, 2018, the United States Food & Drug Administration (“FDA”) approved the oral formulation of TPOXX® for the treatment of smallpox.

The Company has been delivering oral TPOXX® to the U.S.

Strategic National Stockpile ("Strategic Stockpile") since 2013.

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 completed an immunogenicity trial and an expanded safety trial in early 2023.

The nature and timing of a submission of a supplemental New Drug Application to the FDA (“Supplemental NDA”) for a smallpox PEP indication for oral TPOXX® will be based on the results of the trials;

the Company is currently targeting a Supplemental NDA filing in 2024.

In connection with the 2022 global response to an mpox outbreak, a series of observational and randomized, placebo-controlled clinical trials were initiated to assess the safety and efficacy of TPOXX® in participants with mpox.

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

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

The Company may be able to use data from the trials noted above, as well as from other trials, to potentially pursue an FDA label expansion of oral TPOXX® for an indication covering the treatment of mpox.

The viability, and timing, of a potential FDA submission for an mpox indication will be impacted by a series of factors, including the magnitude and severity of future mpox cases, the location of future cases, enrollment in clinical trials, and results of randomized, placebo-controlled and observational clinical trials.

On May 18, 2022 the FDA approved IV TPOXX® for the treatment of smallpox.

In addition to being approved by the FDA, oral TPOXX® (tecovirimat) has received regulatory approval from the European Medicines Agency ("EMA"), Health Canada, the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom, and most recently, in December 2024, the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA").

The EMA, MHRA and PMDA approved oral TPOXX® for the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against smallpox.

Health Canada approved TPOXX® for the treatment of smallpox.

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

In connection with a potential FDA label expansion of oral TPOXX® for an indication covering smallpox post-exposure prophylaxis (“PEP”), the Company has completed an immunogenicity trial and an expanded safety trial.

The timing of a potential submission of a supplemental New Drug Application to the FDA (“Supplemental NDA”) for a smallpox PEP indication for oral TPOXX® will be based on the results of ongoing sample analyses from the immunogenicity trial;

the Company is currently targeting a Supplemental NDA submission in the next twelve months.

Procurement Contracts with the U.S.

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In addition to the delivery of TPOXX® courses, the contract includes funding from BARDA for a range of activities, including:

advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, and procurement activities.

advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, development for a pediatric formulation, and procurement activities.

As of December 31, 2024, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $602.5 million of payments, of which approximately $51.7 million of payments are included within the base period of performance, approximately $519.6 million of payments are related to exercised options and up to approximately $31.2 million of payments are currently specified as unexercised options.

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

The options that have been exercised to date provide for payments up to approximately $407.1 million.

There are exercised options for the following activities:

The options that have been exercised as of December 31, 2024, provide for payments up to approximately $519.6 million.

As of December 31, 2024, there are exercised options for the following activities:

payments up to $450.2 million for the manufacture and delivery of up to 1.5 million courses of oral TPOXX®;

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

As of December 31, 2023, the Company has cumulatively delivered $323.0 million of oral TPOXX® to the Strategic Stockpile, of which $97.9 million was delivered in the fourth quarter of 2023;

has cumulatively received $20.5 million for the completed manufacture of IV BDS;

and has been cumulatively reimbursed $7.9 million in connection with post-marketing activities for oral and IV TPOXX®.

In the first two months of 2024 ended February 29, 2024, approximately $15 million of oral TPOXX® was delivered to the Strategic Stockpile.

As of December 31, 2024, a cumulative total of $396.9 million of oral TPOXX® has been delivered to the Strategic Stockpile and accepted, of which approximately $15 million was delivered in the first quarter of 2024, approximately $8 million was delivered in the third quarter of 2024, and approximately $51 million was delivered in the fourth quarter of 2024;

a cumulative total of $25.4 million of IV FDP has been delivered to the Strategic Stockpile and accepted, of which approximately $17 million of revenue (including recognition of deferred revenue) was recorded in the second quarter of 2024 and approximately $8 million of revenue (including recognition of deferred revenue) was recorded in the fourth quarter of 2024;

$10.3 million has been received for the manufacture of IV BDS (such amount is recorded as deferred revenue);

and the Company has been cumulatively reimbursed $9.4 million in connection with post-marketing activities for oral and IV TPOXX®.

Unexercised options specify potential payments up to approximately $31.2 million in total (if all such options are exercised), of which approximately $5.6 million relates to supportive activities that we currently do not expect to be required.

There are options for the following activities:

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

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

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

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

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

If BARDA decides to only exercise the remaining IV BDS Option, then the Company would receive payments up to $10.2 million;

If BARDA decides only to exercise the remaining IV BDS Option, then the Company would receive payments up to $10.2 million;

alternatively, if BARDA decides to exercise the remaining IV BDS Option and IV FDP Option, then the Company would receive payments up to $25.6 million.

BARDA may also decide not to exercise either remaining option.

For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 32,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP.

The Company estimates that sales of the IV formulation under this contract (under current terms), assuming the remaining IV FDP Option was exercised, would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%.

Under the terms of this contract, exercise of procurement options is at the sole discretion of BARDA.

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

Based on prior product delivery activity, and current FDA-approved shelf life of oral TPOXX®, the Company estimates that the remaining options under the 19C BARDA Contract for 363,000 courses of oral TPOXX® (value of $112.5 million) and 32,000 courses of IV FDP (value of $25.6 million) would need to be exercised in 2024 in order to approximately maintain historical stockpile levels of unexpired TPOXX® treatment in the Strategic Stockpile.

Department of Defense Procurement Contracts

On May 12, 2022, the Company announced a contract with the U.S.

Department of Defense ("DoD") for the procurement of oral TPOXX® ("DoD Contract #1").

The DoD Contract #1 included a firm commitment for the DoD to procure approximately $3.6 million of oral TPOXX®, and an option, exercisable at the sole discretion of the DoD, for the procurement of an additional approximately $3.8 million of oral TPOXX®.

In the second quarter of 2022, the Company delivered oral TPOXX® to the DoD and recognized revenue of $3.6 million, fulfilling the firm commitment in DoD Contract #1.

In the third quarter of 2022, the DoD exercised the option for $3.8 million of oral TPOXX® and the Company satisfied its obligation by delivering product in September 2022 and recognized the related revenue.

On September 28, 2022, the Company and the DoD signed a new procurement contract ("DoD Contract #2").

The DoD Contract #2 included a firm commitment for the DoD to procure approximately $5.1 million of oral TPOXX®, and an option, exercisable at the sole discretion of the DoD for the procurement of an additional approximately $5.5 million of oral TPOXX®.

In March 2023, the Company fulfilled the firm commitment by delivering $5.1 million of oral TPOXX® to the DoD, and recognized the related revenue.

Additionally, in March 2023 the DoD exercised the $5.5 million option in DoD Contract #2 for the procurement of oral TPOXX® and the Company delivered these courses to the DoD in the fourth quarter of 2023.

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

International Procurement Contracts

In 2023, the Company has delivered, and received acceptance for, approximately $21.3 million of oral TPOXX® to five European countries, one Middle Eastern country, and one Asia Pacific country.

In the first two months of 2024 ending February 29, 2024, the Company delivered an additional approximately $7 million of oral TPOXX® to six countries in Europe, completing greater than 95% of deliveries under the $18 million of firm commitment orders from 13 countries under the European Commission’s DG HERA (Health Emergency Preparedness and Response Authority) joint procurement mechanism, which was announced by the Company in October 2022.

Additionally, $0.7 million of oral TPOXX® was delivered to the Canada Department of National Defence ("CDND") in February 2024.

These deliveries were made in connection with orders and contracts under the International Promotion Agreement (defined and discussed below).

Through the International Promotion Agreement, Meridian Medical Technologies, Inc.

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

In addition to the above-mentioned orders and deliveries, the Company has a contract with the CDND under which the CDND has an option until December 31, 2025, exercisable at its sole discretion, for the purchase of up to an additional $6.7 million of oral TPOXX®.

As an international contract, this contract is also administered under the International Promotion Agreement.

The contract with the CDND (the "Canadian Military Contract"), issued in April of 2020 and subsequently amended, is option-based and initially specified that the CDND would purchase up to $14 million of oral TPOXX® if all options were exercised.

In 2024, the Company had sales of approximately $10 million with the U.S.

Department of Defense ("DoD").

Sales consist mostly of delivery of oral TPOXX®, with a minor amount of IV TPOXX® delivered.

In 2023, the Company had sales of approximately $11 million with the DoD.

Sales consist of delivery of oral TPOXX®.

Over the past three years, the Company has received three procurement contracts from the DoD, including a $9 million contract in August 2024, which has been fulfilled.

International Sales Activity

In the year ended December 31, 2024, the Company had international sales of $23.0 million consisting of deliveries of oral TPOXX® to 13 countries.

For international sales in the first and second quarters, Meridian Medical Technologies ("Meridian") was the counterparty to contracts under which the sales were made (see discussion and definition below regarding International Promotion Agreement).

For international sales in the third and fourth quarters, the Company was the counterparty to the contracts under which the sales were made.

In the year ended December 31, 2023, the Company had international sales of $21.3 million consisting of deliveries of oral TPOXX® to seven countries.

International Promotion Agreement

Under the terms of the International Promotion Agreement, as amended, which has an initial term that expires on May 31, 2024, Meridian was granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States (the “Territory”), and Meridian has agreed not to commercialize any competing product, as defined in the International Promotion Agreement, in the specified field of use in the Territory.

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

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

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

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

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

For purposes of this disclosure, contribution margin (in amount) represents international product sales less applicable cost of sales and the Meridian fee (which is included within selling, general and administrative expenses within the income statement).

Under the terms of the current International Promotion Agreement, which was amended on March 27, 2024, and effective June 1, 2024, and further amended on August 30, 2024, the Company has primary responsibility for the advertising, promotion and sale of oral TPOXX® in all geographic regions.

Meridian has limited, non-exclusive rights to advertise, promote, offer for sale and sell oral TPOXX® in the European Economic Area, Australia, Japan, Switzerland, the United Kingdom and the Association of Southeast Asian Nations and its member states (collectively, the “Current Territory”).

Meridian also performs non-promotional activities under specified contracts with third parties entered into prior to June 1, 2024, that provide for the sale of oral TPOXX® in the Current Territory.

The International Promotion Agreement entitles Meridian to receive a fee equal to a high single digit percentage of collected proceeds (whether collected by Meridian or the Company), net of certain expenses, of sales of oral TPOXX® in the Current Territory in the field of use specified in the International Promotion Agreement.

The International Promotion Agreement has a fixed term that expires on May 31, 2026, with no automatic renewal.

Under the terms of the original International Promotion Agreement ("Pre-amendment International Promotion Agreement"), which had an initial term that expired on May 31, 2024, Meridian had been granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States (the “Territory”), and Meridian agreed not to commercialize any competing product, as defined in the Pre-amendment International Promotion Agreement, in the specified field of use in the Territory.

Under the Pre-amendment International Promotion Agreement, as well as the current International Promotion Agreement, SIGA has always retained ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, also retained sales and marketing rights with respect to oral TPOXX®.

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

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

and Meridian was entitled to a specified percentage of the collected proceeds of sales of oral TPOXX®, net of certain expenses, for calendar years in which customer collected amounts net of such expenses were less than or equal to a specified threshold, and to a higher specified percentage of such collected net proceeds for calendar years in which such net collected amounts exceeded the specified threshold.

Subsequent to June 1, 2024, only specified procurement contracts for the Current Territory entered into prior to June 1, 2024, continue to involve Meridian invoicing and collecting proceeds, and retaining a fee pursuant to the International Promotion Agreement.

In connection with the 2022 response to a global mpox outbreak, a series of observational and randomized, placebo-controlled clinical trials were initiated to assess the safety and efficacy of TPOXX® in participants with mpox.

The purpose of these randomized clinical trials is to seek to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease.

As of December 31, 2024, two of the randomized, placebo-controlled clinical trials reported preliminary topline results:

a randomized, placebo-controlled clinical trial in the Democratic Republic of the Congo ("DRC") known as PALM 007 (Tecovirimat for Treatment of Monkeypox Virus - NCT05559099), which is funded and sponsored by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID);

and the Study of Tecovirimat for Human Mpox Virus (STOMP) clinical trial (NCT05534984), which is a randomized, placebo-controlled, double-blind study sponsored and funded by NIAID to evaluate the safety and efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive mpox disease that included enrollees from Argentina, Brazil, Japan, Mexico, Peru, Thailand, and the United States.

The PALM 007 study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the DRC with mpox who received TPOXX® compared to patients who received placebo.

Some improvement versus placebo was observed in patients receiving TPOXX® whose symptoms began seven days or fewer before randomization and patients with severe or grave disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions, however the significance of these data have not been established.

An interim analysis of data from the STOMP study showed that TPOXX® did not demonstrate efficacy in time to skin and mucosal lesion resolution compared to placebo in patients with mild to moderate clade II mpox.

Based on this result and additional analyses, the study Data Safety and Monitoring Board (DSMB) recommended to stop enrolling patients in the randomized arms of the study.

NIAID accepted this recommendation and subsequently decided to take a similar action in the open label arm of this study, which included severe and at-risk of developing severe disease patients.

Data analysis is not yet complete for primary endpoint subgroups and detailed secondary and exploratory endpoints.

In both studies, TPOXX® exhibited a safety profile comparable to placebo.

These safety results are consistent with prior studies and further support the strong safety profile that has been observed with tecovirimat over the past 15 years.

Three randomized clinical trials, UNITY (Switzerland, Brazil, Argentina), Platinum-CAN (Canada), and EPOXI (EU), are enrolling mpox patients.

Given the STOMP and PALM007 results and the design similarities across these mpox trials, the Company believes the ongoing trials are likely to yield similar results.

Research Agreements and Grants

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

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

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

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

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

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

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

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

(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 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.

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, Grace is also paid for related services, such as stability testing.

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

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

On September 30, 2024, the contract term automatically renewed for a one-year term.

Upon September 30, 2024, and each anniversary thereafter, the agreement will renew for successive one-year renewal terms until either the Company or Grace provides notice of non-renewal at least 90 days prior to the expiration date of a term.

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

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

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

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

As such, until June 28, 2027, SIGA will purchase all of its requirements for bulk product under the 19C BARDA Contract from Catalent.

Thereafter, this agreement became subject to automatic three year renewals.

As such, until June 28, 2027, SIGA will purchase all of its requirements for bulk product for oral TPOXX® under the 19C BARDA Contract from Catalent.

PCI provides packaging services in connection with oral TPOXX®.

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

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

Notice has not been provided by either party and, as such, the agreement has been automatically extended to March 1, 2025.

The agreement can be terminated earlier than March 1, 2025 under certain conditions.

Since March 2022, this agreement has automatically renewed for successive one-year periods.

Intravenous (IV) formulation of TPOXX®:

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

As such, the agreement has automatically extended to December 31, 2024.

As such, the agreement automatically extended on December 31, 2024 to December 31, 2025.

Patheon manufactures, tests and packages IV TPOXX®.

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Corporate Responsibility and Sustainability

SIGA focuses on the health security market and seeks to advance global health while promoting a sustainable environment.

SIGA seeks to advance global public health through its development and commercial activities, which include (i) delivering medical countermeasures to governments and/or non-governmental organizations ("NGOs") so that governments and/or NGOs can cost-effectively stockpile treatments for potential public health emergencies and (ii) donating therapies to NGOs to treat patients with serious infectious diseases in developing countries or those who are being treated on a compassionate basis and/or within clinical trials.

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

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

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

SIGA focuses on the health security market and seeks to advance global health through its development and commercial activities, which include (i) delivering medical countermeasures to governments and/or non-governmental organizations ("NGOs") so that governments and/or NGOs can cost-effectively stockpile treatments for potential public health emergencies and (ii) donating therapies to NGOs to treat patients with serious infectious diseases in developing countries or those who are being treated on a compassionate basis and/or within clinical trials.

Market for Medical Countermeasures for Biological Threats

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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.

Amounts under contracts, including grant agreements, are not guaranteed because those contracts can be canceled at any time for reasons such as non-performance or convenience of the U.S.

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

With respect to international government contracts, we receive cash payments based on the terms of the contract or, for certain contracts entered into by Meridian prior to June 1, 2024, the terms contained within the International Promotion Agreement with Meridian, under which Meridian collects payments from foreign governments.

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

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Government with respect to medical countermeasure products.

Human Capital Resources and Research Facilities

Human Capital Resources

As of February 14, 2025, we had 46 full-time employees.

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

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

Intellectual Property and Proprietary Rights

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

As of January 17, 2024, the TPOXX® patent portfolio has seven patent families consisting of 30 U.S.

utility patents, 109 issued foreign patents, two U.S.

utility patent applications, and 16 foreign patent applications.

As of February 1, 2025, the TPOXX® patent portfolio has seven patent families consisting of 25 U.S.

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

utility patent application, and 14 foreign patent applications.

The principal and material issued patents covering TPOXX® are described in the table below.

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United States

Method of manufacturing ST-246

March 30, 2010

September 27, 2024

United States

Composition of matter for the ST-246 compound and Pharmaceutical compositions containing ST-246

February 28, 2012

June 18, 2024

United States

Method of manufacturing ST-246

June 18, 2024

United States

Pharmaceutical compositions containing a mixture of compounds including ST-246

September 10, 2013

June 18, 2024

United States

Method of treating orthopoxvirus infection with a mixture of compounds including ST-246

August 12, 2014

June 18, 2024

United States

Method of manufacturing ST-246

June 18, 2024

United States

Liquid Pharmaceutical formulations containing ST-246

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February 15, 2037

United States

Methods of treating orthopoxvirus using a certain polymorph

February 6, 2024

March 23, 2031

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

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August 2, 2031

Therapeutic agent for treating orthopoxvirus including ST-246, pharmaceutical composition of matter for the ST-246 compound and method of manufacturing ST-246

December 16, 2011

June 18, 2024

Method of manufacturing ST-246

December 5, 2014

June 18, 2024

Liquid Pharmaceutical formulations containing ST-246

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August 14, 2033

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

August 13, 2013

June 18, 2024

Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246

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August 14, 2033

AU 2004249250

Method of treating orthopoxvirus infection, pharmaceutical composition containing ST-246 and composition of matter for the ST-246 compound

March 29, 2012

June 18, 2024

AU 2007351866

Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246

January 10, 2013

June 18, 2024

Amorphous Tecovirimat preparation

October 15, 2024

July 11, 2034

AU 2011232551

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AU 2014290333

Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246

August 18, 2016

June 18, 2024

AU 2014290333

Amorphous Tecovirimat preparation

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August 14, 2033

AU 2022202841

Methods of preparing Tecovirimat

February 1, 2024

August 14, 2033

AU 2022218556

ST-246 suspension formulations

November 28, 2024

February 15, 2037

ARIPO*/Africa

45 unchanged sentences

June 18, 2029

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

April 12, 2017

June 18, 2024

Polymorphic forms of ST-246

4 unchanged sentences

August 2, 2031

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

April 12, 2017

June 18, 2024

Polymorphic forms of ST-246

4 unchanged sentences

August 2, 2031

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

April 12, 2017

June 18, 2024

Polymorphic forms of ST-246

19 unchanged sentences

July 11, 2034

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

April 12, 2017

June 18, 2024

Polymorphic forms of ST-246

7 unchanged sentences

June 18, 2029

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

April 12, 2017

June 18, 2024

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

April 12, 2017

June 18, 2024

Methods of preparing Tecovirimat

20 unchanged sentences

United Kingdom

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

April 12, 2017

June 18, 2024

United Kingdom

Methods of preparing Tecovirimat

31 unchanged sentences

October 28, 2033

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

April 12, 2017

June 18, 2024

IT 502017000078377

8 unchanged sentences

June 18, 2029

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

April 12, 2017

June 18, 2029

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

2 unchanged sentences

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

In addition to the patents listed in the above chart, the principal and material patent applications covering TPOXX® include patent filings in multiple jurisdictions, including the United States, Europe, Asia, Australia, and other commercially significant markets.

We hold 15 patent applications currently pending with respect to various compositions of TPOXX®, methods of manufacturing, and methods of treatment.

31 unchanged sentences

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

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

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

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

18 unchanged sentences

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 MAA was filed under the centralized application process, which, upon approval, enables sales, including procurement for stockpiling, of oral tecovirimat in all EU Member States, as well as Norway, Iceland, and Liechtenstein.

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

26 unchanged sentences

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

Since 2007, the Secretary of HHS has issued nine declarations under the PREP Act to protect from liability countermeasures that are necessary to prepare the nation for potential pandemics or epidemics, including a declaration on October 10, 2008 that provides immunity from tort liability as it relates to smallpox.

Since 2007, the Secretary of HHS has issued twelve declarations under the PREP Act to protect from liability countermeasures that are necessary to prepare the nation for potential pandemics or epidemics, including a declaration on October 10, 2008 that provides immunity from tort liability as it relates to smallpox.

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.

10 unchanged sentences

Availability of Reports and Other Information

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 .

In addition, our website can be found on the internet at www.siga.com.

The website contains information about us and our operations.

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

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

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

Audit Committee Charter;

Compensation Committee Charter;

Nominating and Corporate Governance Committee Charter;

Code of Ethics and Business Conduct.

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

Our internet address is www.siga.com.

Our investor relations website is located at https://investor.siga.com.

We make available free of charge on our investor relations website under “Financials” our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy and information statements, our directors’ and officers’ Section 16 reports and any amendments to those reports as soon as reasonably practicable after filing or furnishing such materials to the SEC.

They are also available for free on the SEC’s website at www.sec.gov.

We use our investor relations website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD.

Investors should monitor such website, in addition to following our press releases, SEC filings and public conference calls and webcasts.

Information relating to our corporate governance is also included on our investor relations website, including copies of our Code of Ethics and Business Conduct, Corporate Governance Guidelines, and the charters of the committees of our Board of Directors.

The information in or accessible through the SEC and our website are not incorporated into, and are not considered part of, this filing.

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