SIGA TECHNOLOGIES INC

Previous wording

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 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 the trials; the Company is currently targeting a Supplemental NDA filing within the next twelve months.

Current wording

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 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 the trials; the Company is currently targeting a Supplemental NDA filing to occur in the third quarter of 2025.

Previous wording

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 June 30, 2024, there were four currently active randomized, placebo-controlled clinical trials, three of which are still enrolling patients, subject to patient availability, and one of which has completed its enrollment, in locations including the United States, the Democratic Republic of Congo ("DRC") and South America. 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.

Current wording

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. These randomized clinical trials are seeking to collect data on the potential benefits of using TPOXX® as an antiviral treatment for active mpox disease. As of September 30, 2024, there were four active randomized, placebo-controlled clinical trials enrolling patients, subject to patient availability, at sites located in, among other places, the United States and South America. Additionally, 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), recently completed enrollment and reported preliminary topline results. Although the 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 monkeypox (mpox), who were administered TPOXX® compared to patients who were administered placebo, 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.

Previous wording

The Company may be able to use data from the trials noted above, as well as from other trials, to pursue a potential label expansion with the FDA for oral TPOXX® as a treatment for mpox. A Supplemental NDA submission for an mpox indication could occur, if at all, as early as 2025. 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.

Current wording

The Company may be able to use data from the trials noted above, as well as from other trials, to pursue a potential label expansion with the FDA for oral TPOXX® as a treatment for 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 final results of randomized, placebo-controlled and observational clinical trials.

Previous wording

On April 11, 2024, the Company’s partner in Japan, Japan Biotechno Pharma, announced that a new drug application for oral TPOXX® (tecovirimat) was filed in Japan for the treatment of smallpox, mpox, cowpox, and complications due to vaccinia virus.

Current wording

On April 11, 2024, the Company’s partner in Japan, Japan Biotechno Pharma, announced that a new drug application for oral TPOXX® (tecovirimat) was filed in Japan for the treatment of smallpox, mpox, cowpox, and complications due to vaccinia virus. Based on the standard review time for a new drug application in Japan, we anticipate a final regulatory decision by the end of the first quarter of 2025.

Previous wording

On September 10, 2018, the Company entered into a contract with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX® to the Strategic Stockpile, and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of IV TPOXX®. In October 2023, the contract was modified so that a course of IV TPOXX® was redefined within the contract from being 14 vials to being 28 vials; as such, the 19C BARDA Contract currently specifies 106,000 courses of IV TPOXX® (for the same payment amount as originally specified). In addition to the delivery of TPOXX® courses, the contract includes funding from BARDA for a range of activities, including: advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, and procurement activities. As of June 30, 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 $407.1 million of payments are related to exercised options and up to approximately $143.7 million of payments are currently specified as unexercised options. Subsequent to June 30, 2024, on July 18, 2024, an option for the procurement of $112.5 million of oral TPOXX® was exercised by BARDA, increasing cumulative exercised options to $519.6 million and reducing the amount of unexercised options to $31.2 million. BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term.

Current wording

On September 10, 2018, the Company entered into a contract with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX® to the Strategic Stockpile, and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of IV TPOXX®. In October 2023, the contract was modified so that a course of IV TPOXX® was redefined within the contract from being 14 vials to being 28 vials; as such, the 19C BARDA Contract currently specifies 106,000 courses of IV TPOXX® (for the same payment amount as originally specified). In addition to the delivery of TPOXX® courses, the contract includes funding from BARDA for a range of activities, including: advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, and procurement activities. As of September 30, 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. BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term.

Previous wording

The base period of performance specifies potential payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 10,000 courses (as currently defined within the contract as being 28 vials) of final drug product of IV TPOXX® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities. As of June 30, 2024, the Company had received $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS, $4.3 million for the delivery of IV FDP to the Strategic Stockpile and $23.7 million for other base period activities. IV BDS has been used for the manufacture of courses of IV FDP. The $3.2 million received for the completed manufacture of IV BDS had been recorded as deferred revenue as of December 31, 2021, but with the delivery of IV FDP to the Strategic Stockpile during 2022, $2.9 million was recognized as revenue. The remaining $0.3 million of deferred revenue was recognized in the second quarter of 2024 as the IV FDP containing such IV BDS was delivered to and accepted by the Strategic Stockpile.

Current wording

The base period of performance specifies potential payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 10,000 courses (as currently defined within the contract as being 28 vials) of final drug product of IV TPOXX® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities. As of September 30, 2024, the Company had received $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS, $4.8 million for the delivery of IV FDP to the Strategic Stockpile and $24.7 million for other base period activities. IV BDS has been used for the manufacture of courses of IV FDP. The $3.2 million received for the completed manufacture of IV BDS had been recorded as deferred revenue as of December 31, 2021, but with the delivery of IV FDP to the Strategic Stockpile during 2022, $2.9 million was recognized as revenue. The remaining $0.3 million of deferred revenue was recognized in the second quarter of 2024 as the IV FDP containing such IV BDS was delivered to and accepted by the Strategic Stockpile.

Previous wording

The options that have been exercised as of June 30, 2024, provide for payments up to approximately $407.1 million. As of June 30, 2024, there are exercised options for the following activities: payments up to $337.7 million for the manufacture and delivery of up to 1.1 million courses of oral TPOXX®; payments up to $51.2 million for the manufacture of courses of IV FDP, of which $20.5 million of payments relate to the manufacture of IV BDS to be used in the manufacture of IV FDP; payments of up to approximately $3.6 million to fund post-marketing activities for IV TPOXX®; and payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX®. As of June 30, 2024, the Company has cumulatively delivered $337.7 million of oral TPOXX® to the Strategic Stockpile, of which approximately $15 million was delivered in the first quarter of 2024; has cumulatively received $20.5 million for the completed manufacture of IV BDS, of which $6.8 million was recognized as revenue in the second quarter of 2024 as the IV FDP containing such IV BDS was delivered to and accepted by the Strategic Stockpile, and the remaining $13.7 million was recorded as deferred revenue as of June 30, 2024; and has been cumulatively reimbursed $8.6 million in connection with post-marketing activities for oral and IV TPOXX®.

Current wording

The options that have been exercised as of September 30, 2024, provide for payments up to approximately $519.6 million. As of September 30, 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®; payments up to $51.2 million for the manufacture of courses of IV FDP, of which $20.5 million of payments relate to the manufacture of IV BDS to be used in the manufacture of IV FDP; payments of up to approximately $3.6 million to fund post-marketing activities for IV TPOXX®; and payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX®. As of September 30, 2024, a cumulative total of $345.8 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 and approximately $8 million was delivered in the third quarter of 2024; the Company has cumulatively received $20.5 million for the completed manufacture of IV BDS, of which $6.8 million was recognized as revenue in the second quarter of 2024 as the IV FDP containing such IV BDS was delivered to and accepted by the Strategic Stockpile, and the remaining $13.7 million was recorded as deferred revenue as of September 30, 2024; and the Company has been cumulatively reimbursed $9.0 million in connection with post-marketing activities for oral and IV TPOXX®. In October 2024, $51.2 million of oral TPOXX® was delivered and/or accepted by the Strategic National Stockpile and $8.5 million of IV TPOXX® was delivered and/or accepted by the Strategic National Stockpile.

Previous wording

Unexercised options specify potential payments up to approximately $143.7 million in total (if all such options are exercised), of which approximately $5.6 million relates to supportive activities that we currently do not expect to be required. The remaining unexercised options specify potential payments 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. Subsequent to June 30, 2024, on July 18, 2024, an option for the procurement of $112.5 million of oral TPOXX® was exercised by BARDA, increasing cumulative exercised options to $519.6 million and reducing the amount of unexercised options to $31.2 million.

Current wording

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. 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.

Previous wording

In the three and six months ended June 30, 2024, the Company had international sales of $3.0 million and $11.0 million, respectively. Sales consist of deliveries of oral TPOXX® to 11 countries. These sales were made under the International Promotion Agreement (defined and discussed below). Through the International Promotion Agreement, Meridian was the counterparty to international contracts under which the sales were made.

Current wording

In the three and nine months ended September 30, 2024, the Company had international sales of $0.8 million and $11.8 million, respectively. Sales for the nine months ended September 30, 2024 consist of deliveries of oral TPOXX® to 12 countries. Sales in the first and second quarters were made under the International Promotion Agreement (defined and discussed below). Through the International Promotion Agreement, Meridian was the counterparty to international contracts under which the sales were made.

Previous wording

Under the terms of the current International Promotion Agreement, which was amended on March 27, 2024 (effective June 1, 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 and the United Kingdom (collectively, the “Current Territory”). Meridian also performs non-promotional activities under specified existing contracts with third parties providing for the sale of oral TPOXX®. The International Promotion Agreement provides that Meridian is entitled 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.

Current wording

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 existing contracts with third parties providing for the sale of oral TPOXX®. The International Promotion Agreement provides that Meridian is entitled 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.

Previous wording

For the three months ended June 30, 2024, revenues from product sales and supportive services were $20.7 million. Such revenues include $17.6 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA Contract, and approximately $3.1 million of oral TPOXX® international sales. For the three months ended June 30, 2023, revenues from product sales and supportive services were $1.3 million. Such revenues primarily relate to a sale of oral TPOXX® to a European country.

Current wording

For the three months ended September 30, 2024, revenues from product sales and supportive services were $8.9 million. Such revenues include $8.1 million of Oral TPOXX® sales to the U.S. Government under the 19C BARDA Contract, and $0.8 million of oral TPOXX® international sales. For the three months ended September 30, 2023, revenues from product sales and supportive services were $8.0 million. Such revenues primarily relate to a sale of oral TPOXX® to a European country and a Middle Eastern country.

Previous wording

Revenues from research and development activities for the three months ended June 30, 2024 and 2023, were $1.1 million and $4.6 million, respectively. The revenues for the three months ended June 30, 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The revenue for the three months ended June 30, 2023, were mostly earned in connection with performance of research and development activities under the PEP Label Expansion R&D Contract and the 19C BARDA Contract. The decrease of $3.5 million of revenue is primarily related to the completion of billable activities under the PEP Label Expansion R&D Contract.

Current wording

Revenues from research and development activities for the three months ended September 30, 2024 and 2023, were $1.1 million and $1.3 million, respectively. The revenues for the three months ended September 30, 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The revenue for the three months ended September 30, 2023, were mostly earned in connection with performance of research and development activities under the PEP Label Expansion R&D Contract and the 19C BARDA Contract. The decrease of $0.2 million of revenue is primarily related to the completion of billable activities under the PEP Label Expansion R&D Contract.

Previous wording

Cost of sales and supportive services for the three months ended June 30, 2024 and 2023 were $12.3 million and $1.0 million, respectively. Such costs in 2024 were associated with the manufacture and delivery of courses of IV TPOXX® to the U.S. Government under the 19C BARDA Contract and the manufacture and delivery of oral TPOXX® to multiple international countries. Such costs in 2023 were primarily associated with the manufacture and delivery of courses of oral TPOXX® to a European country, as well as an inventory-related loss of $0.5 million in connection with the impairment of a manufacturing batch.

Current wording

Cost of sales and supportive services for the three months ended September 30, 2024 and 2023 were $1.6 million and $0.9 million, respectively. Such costs in 2024 were associated with the manufacture and delivery of courses of Oral TPOXX® to the U.S. Government under the 19C BARDA Contract. Such costs in 2023 were associated with the manufacture and delivery of courses of oral TPOXX® to a European country and a Middle Eastern country, and the costs of supportive activities such as customary, periodic stability testing.

Previous wording

Selling, general and administrative (“SG&A”) expenses for the three months ended June 30, 2024 and 2023 were $5.5 million and $4.4 million, respectively. The increase of approximately $1.1 million primarily reflects the promotion fees incurred in connection with second quarter 2024 international sales and higher compensation expense associated with the hiring of multiple executive officers since September 2023, partially offset by lower professional service fees.

Current wording

Selling, general and administrative (“SG&A”) expenses for the three months ended September 30, 2024 and 2023 were $4.8 million and $6.0 million, respectively. The decrease of approximately $1.2 million primarily reflects the decrease in international promotion fees due to the decrease in international sales in 2024 in comparison to the same period in 2023, partially offset by higher compensation expense associated with the hiring of multiple executive officers this year.

Previous wording

Research and development (“R&D”) expenses for the three months ended June 30, 2024 and 2023 were $2.9 million and $5.1 million, respectively, reflecting a decrease of approximately $2.2 million. The decrease is primarily attributable to lower direct vendor-related expenses incurred in connection with a decrease in activities under the PEP Label Expansion R&D Contract.

Current wording

Research and development (“R&D”) expenses for the three months ended September 30, 2024 and 2023 were $3.0 million and $3.6 million, respectively, reflecting a decrease of approximately $0.6 million. The decrease is primarily attributable to lower direct vendor-related expenses incurred in connection with a decrease in activities under the PEP Label Expansion R&D Contract, partially offset by an increase in compensation expense in connection with an increase in headcount.

Previous wording

Other income, net for the three months ended June 30, 2024 and 2023 were $1.3 million and $1.2 million, respectively. These amounts reflect interest income earned on cash and cash equivalents.

Current wording

Other income, net for the three months ended September 30, 2024 and 2023 were $1.3 million and $0.9 million, respectively. These amounts reflect interest income earned on cash and cash equivalents.

Previous wording

For the six months ended June 30, 2024, revenues from product sales and supportive services were $44.6 million. Such revenues include $17.6 million of IV TPOXX® and $14.7 million of oral TPOXX® sales to the U.S. Government under the 19C BARDA Contract, $11.0 million of oral TPOXX® international sales and approximately $1.1 million of oral TPOXX® sales to the DoD. For the six months ended June 30, 2023, revenues from product sales and supportive services were $7.0 million. Such revenues primarily relate to sales of oral TPOXX® to the DoD and to a European country.

Current wording

For the nine months ended September 30, 2024, revenues from product sales and supportive services were $53.5 million. Such revenues include $17.6 million of IV TPOXX® and $22.8 million of oral TPOXX® sales to the U.S. Government under the 19C BARDA Contract, $11.8 million of oral TPOXX® international sales and approximately $1.1 million of oral TPOXX® sales to the DoD. For the nine months ended September 30, 2023, revenues from product sales and supportive services were $14.9 million. Such revenues primarily relate to sales of approximately $5.1 million of oral TPOXX® to the DoD and approximately $9.1 million of international sales of oral TPOXX®.

Previous wording

Revenues from research and development activities for the six months ended June 30, 2024 and 2023, were $2.7 million and $7.2 million, respectively. The revenues for the six months ended June 30, 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The revenue for the six months ended June 30, 2023, were mostly earned in connection with performance of research and development activities under the PEP Label Expansion R&D Contract and the 19C BARDA Contract. The decrease of $4.5 million of revenue is primarily related to the completion of billable activities under the PEP Label Expansion R&D Contract.

Current wording

Revenues from research and development activities for the nine months ended September 30, 2024 and 2023, were $3.8 million and $8.5 million, respectively. The revenues for the nine months ended September 30, 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The revenue for the nine months ended September 30, 2023, were mostly earned in connection with performance of research and development activities under the PEP Label Expansion R&D Contract and the 19C BARDA Contract. The decrease of $4.7 million of revenue is primarily related to the completion of billable activities under the PEP Label Expansion R&D Contract.

Previous wording

Cost of sales and supportive services for the six months ended June 30, 2024 and 2023 were $15.5 million and $2.1 million, respectively. Such costs in 2024 were associated with the manufacture and delivery of courses of IV and oral TPOXX® to the U.S. Government under the 19C BARDA Contract, as well as the manufacture and delivery of oral TPOXX® to multiple international countries and the DoD. Such costs in 2023 are associated with: the manufacture and delivery of courses of oral TPOXX® to the DoD and a European country; an inventory-related loss in connection with impairment of a manufacturing batch; and manufacturing costs related to a potential backup facility within a segment of the supply chain.

Current wording

Cost of sales and supportive services for the nine months ended September 30, 2024 and 2023 were $17.2 million and $3.0 million, respectively. Such costs in 2024 were primarily associated with the manufacture and delivery of courses of IV and oral TPOXX® to the U.S. Government under the 19C BARDA Contract, as well as the manufacture and delivery of oral TPOXX® to multiple international countries and the DoD. Such costs in 2023 are associated with: lower sales volume and a different product mix than 2024; the manufacture and delivery of courses of oral TPOXX® to the DoD and three international customers; an inventory-related loss in connection with impairment of a manufacturing batch; manufacturing costs related to a potential backup facility within a segment of the supply chain, and the costs of supportive activities such as customary, periodic stability testing.

Previous wording

Selling, general and administrative (“SG&A”) expenses for the six months ended June 30, 2024 and 2023 were $13.4 million and $8.7 million, respectively. The increase of approximately $4.7 million primarily reflects; the increase in international promotion fees due to the increase of approximately $10 million in international sales in 2024 in comparison to the same period in 2023; higher compensation expense associated with the hiring of multiple executive officers since September 2023; and an increase in consulting fees.

Current wording

Selling, general and administrative (“SG&A”) expenses for the nine months ended September 30, 2024 and 2023 were $18.2 million and $14.7 million, respectively. The increase of approximately $3.5 million primarily reflects; an increase in international promotion fees due to an increase in international sales in 2024 in comparison to the same period in 2023; and higher compensation expense associated with the hiring of multiple executive officers this year.

Previous wording

Research and development (“R&D”) expenses for the six months ended June 30, 2024 and 2023 were $5.9 million and $10.2 million, respectively, reflecting a decrease of approximately $4.3 million. The decrease is primarily attributable to lower direct vendor-related expenses incurred in connection with a decrease in activities under the PEP Label Expansion R&D Contract.

Current wording

Research and development (“R&D”) expenses for the nine months ended September 30, 2024 and 2023 were $9.0 million and $13.8 million, respectively, reflecting a decrease of approximately $4.8 million. The decrease is primarily attributable to lower direct vendor-related expenses incurred in connection with a decrease in activities under the PEP Label Expansion R&D Contract, partially offset by an increase in compensation expense in connection with an increase in headcount.

Previous wording

Other income, net for the six months ended June 30, 2024 and 2023 were $3.3 million and $2.1 million, respectively. The increase relates to interest income earned on cash and cash equivalents as the average cash balance during the six months ended June 30, 2024 were higher than the same period in 2023. Additionally, the average investment rates in the six months ended June 30, 2024 were higher than those in the six months ended June 30, 2023.

Current wording

Other income, net for the nine months ended September 30, 2024 and 2023 were $4.6 million and $3.0 million, respectively. The increase relates to interest income earned on cash and cash equivalents as the average cash balance during the nine months ended September 30, 2024 were higher than the same period in 2023. Additionally, the average investment rates in the nine months ended September 30, 2024 were higher than those in the nine months ended September 30, 2023.

Previous wording

For the six months ended June 30, 2024 and 2023, we recorded pre-tax income/(losses) of $15.6 million and ($4.7) million, respectively, and a corresponding income tax (provision)/benefit of ($3.5) million and $0.9 million, respectively. The effective tax rates during the six months ended June 30, 2024 and 2023 were 22.4% and 18.7%, respectively. Our effective tax rates for the periods ended June 30, 2024 and 2023 differ from the statutory rate primarily as a result of state taxes and non-deductible executive compensation under Internal Revenue Code Section 162(m).

Current wording

For the nine months ended September 30, 2024 and 2023, we recorded pre-tax income/(losses) of $17.5 million and ($5.1) million, respectively, and a corresponding income tax (provision)/benefit of ($4.0) million and $0.9 million, respectively. The effective tax rates during the nine months ended September 30, 2024 and 2023 were 23.1% and 17.8%, respectively. Our effective tax rates for the periods ended September 30, 2024 and 2023 differ from the statutory rate primarily as a result of state taxes and non-deductible executive compensation under Internal Revenue Code Section 162(m).

Previous wording

As of June 30, 2024, we had $106.9 million in cash and cash equivalents, compared with $150.1 million at December 31, 2023. We believe that our liquidity and capital resources will be sufficient to meet our anticipated requirements for at least the next twelve months from the issuance of these financial statements.

Current wording

As of September 30, 2024, we had $99.3 million in cash and cash equivalents, compared with $150.1 million at December 31, 2023. We believe that our liquidity and capital resources will be sufficient to meet our anticipated requirements for at least the next twelve months from the issuance of these financial statements.

Previous wording

Net cash (used in)/provided by operating activities for the six months ended June 30, 2024 and 2023 was ($0.2) million and $20.9 million, respectively. For the six months ended June 30, 2024, the receipt of approximately $49 million from sales of oral and IV TPOXX® to the U.S. Government and international customers, of which approximately $29 million relates to 2024 sales and the remainder to accounts receivable at December 31, 2023, was offset by the payment of approximately $29 million of income taxes as well as for the use of cash for inventory and customary operating activities. For the six months ended June 30, 2023, the receipt of approximately $35 million for 2022 product deliveries was partially offset by an increase in inventory investment in connection with a broadening of the customer base for TPOXX® and mitigation of increasing general supply chain risks; and costs in relation to customary operating activities.

Current wording

Net cash (used in)/provided by operating activities for the nine months ended September 30, 2024 and 2023 was ($7.5) million and $15.8 million, respectively. For the nine months ended September 30, 2024, the receipt of approximately $55 million from sales of oral and IV TPOXX® to the U.S. Government and international customers, of which approximately $35 million relates to 2024 sales and the remainder to accounts receivable at December 31, 2023, was offset by the payment of approximately $29 million of income taxes as well as for the use of cash for inventory and customary operating activities. For the nine months ended September 30, 2023, the receipt of substantially all of the $45 million of accounts receivable as of December 31, 2022, as well as approximately $10 million received in connection with IV BDS deferred revenue was partially offset by the use of cash to proactively build inventory, and for customary operating activities.

Previous wording

There was minimal (less than $25,000) cash-related investing activities for the six months ended June 30, 2024 and 2023.

Current wording

There was minimal (less than $25,000) cash-related investing activities for the nine months ended September 30, 2024 and 2023.

Previous wording

Cash used in financing activities for the six months ended June 30, 2024 was $43.0 million, which was mostly attributable to the payment of a special cash dividend of approximately $42.7 million. Cash used in financing activities for the six months ended June 30, 2023 was $43.4 million, which was mostly attributable to the payment of a special cash dividend of approximately $32.1 million and the repurchase of approximately 1.7 million shares of common stock for approximately $11.0 million.

Current wording

Cash used in financing activities for the nine months ended September 30, 2024 was $43.3 million, which was mostly attributable to the payment of a special cash dividend of approximately $42.7 million. Cash used in financing activities for the nine months ended September 30, 2023 was $43.4 million, which was mostly attributable to the payment of a special cash dividend of approximately $32.1 million and the repurchase of approximately 1.7 million shares of common stock for approximately $11.0 million.

Previous wording

As of June 30, 2024, we had outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $11.3 million.

Current wording

As of September 30, 2024, we had outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $3.3 million.

Previous wording

Certain statements in this Quarterly Report on Form 10-Q, including certain statements contained in the foregoing “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), including statements relating to the progress of SIGA’s development programs and timelines for bringing new indications or products to market, delivering products to domestic and international customers, the enforceability of our procurement contracts, such as the 19C BARDA Contract (the "BARDA Contract"), with BARDA, and responding to the global outbreak of monkeypox ("mpox"). The words or phrases “can be,” “expects,” “may affect,” “may depend,” “believes,” “estimate,” “targeting,” “project” and similar words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the BARDA Contract, not to exercise the remaining unexercised option under the BARDA Contract, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract or PEP Label Expansion R&D Contract are modified or canceled at the request or requirement of, or SIGA is not able to enter into new contracts to supply TPOXX® to, the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX® internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX® that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (viii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, inc…

Excerpt shortened here; the source contains the full paragraph.

Current wording

Forward-looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “seek,” “anticipate,” “could,” “should,” “target,” “goal,” “potential” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the 19C BARDA Contract, not to exercise the remaining unexercised option under the 19C BARDA Contract, (ii) the risk that SIGA may not complete performance under the 19C BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the 19C BARDA Contract or PEP Label Expansion R&D Contract are modified or canceled at the request or requirement of, or SIGA is not able to enter into new contracts to supply TPOXX® to, the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX® internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX® that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (viii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (ix) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (x) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (xi) the…

Excerpt shortened here; the source contains the full paragraph.