Q - SIGA TECHNOLOGIES
For the period ended Jun 30, 2025. Filed Aug 5, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 5, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0001437749-25-015542
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-05.
0001437749-25-024889
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 61 previous paragraphs and 71 current paragraphs.
38 unchanged; 21 reworded; 6 added; 2 removed; 0 previous and 6 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
TPOXX® was authorized under “exceptional circumstances” by the EMA and the MHRA, under the brand name Tecovirimat-SIGA. These regulators granted marketing authorizations under “exceptional circumstances” because it was not possible to obtain complete efficacy and safety information about the product due to the rarity of smallpox and other orthopoxviruses and because ethical considerations prevented conducting the necessary clinical studies. The Tecovirimat-SIGA marketing authorizations under “exceptional circumstances” are subject to certain specific obligations to gather additional data post-approval to help confirm the product’s safety and efficacy. All “exceptional circumstances” marketing authorizations are subject to annual reassessments that consider whether data generated pursuant to the specific obligations continue to confirm its positive benefit-risk profile. These annual reassessments determine whether the product’s marketing authorization should be maintained, changed, suspended, or withdrawn based on its benefit-risk profile.
Current report
On July 24, 2025, the EMA’s Committee for Medicinal Products for Human Use closed its third annual reassessment for Tecovirimat-SIGA and initiated a referral procedure for the product following questions over its effectiveness in the treatment of mpox. These questions were raised following receipt of results from certain clinical trials evaluating tecovirimat as a potential mpox treatment including the PALM007 and STOMP clinical trials. EMA will now review all available data on the safety and efficacy of Tecovirimat-SIGA for its authorized indications and make a recommendation on whether the marketing authorization should be maintained, modified, suspended or withdrawn. The reassessment process by the MHRA, which is substantially similar to the EMA process, is several months behind the EMA process and is ongoing.
Current report
With respect to IV TPOXX®, tariff activity involving the U.S. and Europe may materially increase raw material costs for IV TPOXX® and, in turn, may materially increase IV TPOXX® overall manufacturing costs.
Current report
Selling, general and administrative (“SG&A”) expenses for the three months ended June 30, 2025 and 2024 were $5.5 million in each period. While the total expense remained relatively flat, we incurred a net decrease of expenses in connection with international sales and marketing activity, which was primarily offset by higher compensation expense.
Current report
Six Months Ended June 30, 2025 and 2024
Current report
Cash used in financing activities for the six months ended June 30, 2025 was $43.1 million, which was mostly attributable to the payment of a special cash dividend of approximately $42.9 million. 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.
Removed paragraphs (2)
Previous report
Cash used in financing activities for each of the three months ended March 31, 2025 and 2024 was $0.2 million, which was attributable to the payment of tax obligations in connection with stock issued to employees.
Previous report
On April 8, 2025, the Board of Directors declared a special cash dividend of $0.60 per share on the common stock of the Company. The special cash dividend is payable on May 15, 2025, to shareholders of record at the close of business on April 29, 2025.
Reworded paragraphs (21)
Previous wording
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.
Current wording
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 2026.
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®, development of a pediatric formulation, and procurement activities. On March 26, 2025, an option for the procurement of $25.6 million of IV TPOXX® was exercised by BARDA, increasing cumulative exercised options to $545.2 million and reducing the amount of unexercised options to $5.6 million. As of March 31, 2025, 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 $545.2 million of payments are related to exercised options and up to approximately $5.6 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. On April 8, 2025, total payments contemplated under the contract with BARDA were increased by $14.3 million to $616.8 million when the contract was modified to add funding for activities supporting manufacturing.
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®, development of a pediatric formulation, and procurement activities. On April 8, 2025, total payments contemplated under the contract with BARDA were increased by $14.3 million to add funding for activities supporting manufacturing. On June 3, 2025, total payments contemplated under the contract with BARDA were increased by $13.2 million in connection with the development of the pediatric formulation of TPOXX®. As of June 30, 2025, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $630 million of payments, of which approximately $79.2 million of payments are included within the base period of performance, approximately $545.2 million of payments are related to exercised options and up to approximately $5.6 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 March 31, 2025, 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 $26.3 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 $79.2 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 $59.5 million to fund reimbursed activities; and payments of approximately $0.6 million for supportive procurement activities. As of June 30, 2025, 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 $27.6 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 March 31, 2025, provide for payments up to approximately $545.2 million. As of March 31, 2025, 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 $76.8 million for the manufacture of courses 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 March 31, 2025, a cumulative total of $396.9 million of oral TPOXX® has been delivered to the Strategic Stockpile and accepted; a cumulative total of $35.7 million of IV BDS or IV FDP has been either set aside in inventory or delivered to the Strategic Stockpile and accepted (IV BDS that has been set aside has been recorded as deferred revenue and will be recognized as revenue when the IV BDS is manufactured as IV FDP and delivered); and the Company has been cumulatively reimbursed $9.7 million in connection with post-marketing activities for oral and IV TPOXX®. In April 2025, approximately $53 million of oral TPOXX® and approximately $9 million of IV TPOXX® (including recognition of deferred revenue) was delivered to the Strategic Stockpile.
Current wording
The options that have been exercised as of June 30, 2025, provide for payments up to approximately $545.2 million. As of June 30, 2025, 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 $76.8 million for the manufacture of courses 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, 2025, a cumulative total of $450.2 million of oral TPOXX® has been delivered to the Strategic Stockpile and accepted; a cumulative total of $61.4 million of IV BDS or IV FDP has been either set aside in inventory or delivered to the Strategic Stockpile and accepted (IV BDS that has been set aside has been recorded as deferred revenue and will be recognized as revenue when the IV BDS is manufactured as IV FDP and delivered); and the Company has been cumulatively reimbursed $10.4 million in connection with post-marketing activities for oral and IV TPOXX®.
Previous wording
The options related to IV TPOXX® are divided into two primary manufacturing steps. There are options related to the manufacture of bulk drug substance (“IV BDS Options”), and there are corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA had the sole discretion to choose to exercise any, all, or none of these options. The 19C BARDA Contract included: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 32,000 courses (as currently defined within the contract) of IV TPOXX®; and three separate IV FDP Options, each providing for 32,000 courses of final drug product of IV TPOXX®. BARDA had the sole discretion as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option). To date, BARDA has exercised all three IV BDS options and all three IV FDP options. The Company estimates that sales of the IV formulation under this contract (under current terms), would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%.
Current wording
The options related to IV TPOXX® were divided into two primary manufacturing steps. There were options related to the manufacture of bulk drug substance (“IV BDS Options”), and there were corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA had the sole discretion to choose to exercise any, all, or none of these options. The 19C BARDA Contract included: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 32,000 courses (as currently defined within the contract) of IV TPOXX®; and three separate IV FDP Options, each providing for 32,000 courses of final drug product of IV TPOXX®. BARDA had the sole discretion as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option). To date, BARDA has exercised all three IV BDS options and all three IV FDP options. The Company estimates that sales of the IV formulation under this contract (under current terms), would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%.
Previous wording
In 2024, the Company had sales of approximately $10 million to the U.S. Department of Defense ("DoD") of which approximately $1.1 million was delivered in the first quarter of 2024. Sales consisted mostly of delivery of oral TPOXX®, with a minor amount of IV TPOXX® delivered.
Current wording
In 2024, the Company had sales of approximately $10 million to the U.S. Department of Defense ("DoD") of which approximately $1.1 million was delivered in the first six months of 2024. Sales consisted mostly of delivery of oral TPOXX®, with a minor amount of IV TPOXX® delivered.
Previous wording
In the three months ended March 31, 2025, the Company had international sales of $5.8 million, consisting of a delivery of oral TPOXX® to one country. In the three months ended March 31, 2024, the Company had international sales, including shipping revenue, of $8.0 million consisting of a delivery of oral TPOXX® to eight countries. International sales in the three months ended March 31, 2024, were made under the International Promotion Agreement (defined and discussed below) with Meridian Medical Technologies, LLC ("Meridian"). Through the International Promotion Agreement, Meridian was the counterparty to the international contracts under which sales were made during the three months ended March 31, 2024.
Current wording
In the six months ended June 30, 2025, the Company had international sales of $5.8 million, consisting of a delivery of oral TPOXX® to one country. There was no revenue recognized in connection with international contracts during the three months ended June 30, 2025. In the three and six months ended June 30, 2024, the Company had international sales of $3.0 million and $11.0 million, respectively. International sales in the six months ended June 30, 2024, were made under the International Promotion Agreement (defined and discussed below) with Meridian Medical Technologies, LLC ("Meridian"). Through the International Promotion Agreement, Meridian was the counterparty to the international contracts under which sales were made during the six months ended June 30, 2024.
Previous wording
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 March 31, 2025, 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.
Current wording
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 June 30, 2025, 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 has 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.
Previous wording
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 these ongoing trials are likely to yield similar results.
Current wording
Three other randomized clinical trials, UNITY (Switzerland, Brazil, Argentina), Platinum-CAN (Canada), and EPOXI (EU), which were started in response to the global mpox outbreak, have either recently closed to enrollment or expect to close to enrollment this year. Given the STOMP and PALM007 results and the design similarities across these mpox trials, the Company believes these ongoing trials are likely to yield similar results.
Previous wording
The recently implemented U.S. tariffs, and subsequently implemented retaliatory tariffs, did not materially impact our first quarter results. While the long-term effects remain uncertain, we continue to closely monitor the evolving tariff policy environment which presents a mix of impacts, with the potential for higher product and operating costs.
Current wording
The recently implemented U.S. tariffs, and subsequently implemented retaliatory tariffs, did not materially impact our second quarter results. While the long-term effects remain uncertain, we continue to closely monitor the evolving tariff policy environment which presents a mix of impacts, with the potential for higher product and operating costs.
Previous wording
For the three months ended March 31, 2025, revenues from product sales and supportive services were $5.8 million. Such revenues include $5.8 million of Oral TPOXX® sales to one international country. For the three months ended March 31, 2024, revenues from product sales and supportive services were $23.9 million. Such revenues include $14.7 million of oral TPOXX® sales to the U.S. Government under the 19C BARDA Contract, $7.6 million of oral TPOXX® international sales and approximately $1.1 million of oral TPOXX® sales to the DoD.
Current wording
For the three months ended June 30, 2025, revenues from product sales and supportive services were $79.1 million. Such revenues include $53.3 million of oral TPOXX® and $25.8 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA contract. 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.
Previous wording
Revenues from research and development activities for the three months ended March 31, 2025 and 2024, were $1.2 million and $1.6 million, respectively. The revenues for the three months ended March 31, 2025, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The revenues for the three months ended March 31, 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The decrease of $0.4 million of revenue is primarily related to a decrease in billable activities under the 19C BARDA Contract.
Current wording
Revenues from research and development activities for the three months ended June 30, 2025 and 2024, were $2.0 million and $1.1 million, respectively. The revenues for the three months ended June 30, 2025 and 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The increase of $0.9 million of revenue is primarily related to an increase in billable activities under the 19C BARDA Contract.
Previous wording
Research and development (“R&D”) expenses for the three months ended March 31, 2025 and 2024 were $3.5 million and $3.1 million, respectively, reflecting an increase of approximately $0.4 million. The increase is primarily attributable to the implementation of information technology enhancements, higher compensation expense in connection with an increase in headcount, and an increase in the usage of regulatory consultants.
Current wording
Research and development (“R&D”) expenses for the three months ended June 30, 2025 and 2024 were $4.4 million and $2.9 million, respectively, reflecting an increase of approximately $1.5 million. The expense increase is primarily attributable to an increase in vendor-related research and development activity (a portion of which is funded under the 19C BARDA Contract), as well as higher expenses for the implementation of information technology enhancements, higher compensation expense in connection with an increase in headcount, and an increase in the usage of regulatory consultants.
Previous wording
Other income, net for the three months ended March 31, 2025 and 2024 were $1.7 million and $1.9 million, respectively. These amounts reflect interest income earned on cash and cash equivalents.
Current wording
Other income, net for the three months ended June 30, 2025 and 2024 were $1.6 million and $1.3 million, respectively. These amounts reflect interest income earned on cash and cash equivalents.
Previous wording
For the three months ended March 31, 2025 and 2024, we recorded a pre-tax loss of ($0.6) million and a pre-tax income of $13.2 million, respectively, and a corresponding income tax benefit/(provision) of $0.2 million and ($2.9) million, respectively. The effective tax rates during the three months ended March 31, 2025 and 2024 were 28.4% and 22.2%, respectively. Our effective tax rates for the periods ended March 31, 2025 and 2024 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 three months ended June 30, 2025 and 2024, we recorded pre-tax income of $47.3 million and $2.4 million, respectively, and a corresponding income tax provision of $11.8 million and $0.6 million, respectively. The effective tax rates during the three months ended June 30, 2025 and 2024 were 24.9% and 23.6%, respectively. Our effective tax rates for the periods ended June 30, 2025 and 2024 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
Cost of sales and supportive services for the three months ended March 31, 2025 and 2024 were $0.2 million and $3.2 million, respectively. Such costs in 2025 were associated with the manufacture and delivery of courses of oral TPOXX® partially offset by a recovery for inventory previously written off. 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, to multiple international countries and the DoD.
Current wording
Cost of sales and supportive services for the six months ended June 30, 2025 and 2024 were $25.7 million and $15.5 million, respectively. Such costs in 2025 were associated with the manufacture and delivery of courses of oral and IV TPOXX® to the U.S. Government under the 19C BARDA Contract. 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.
Previous wording
Selling, general and administrative (“SG&A”) expenses for the three months ended March 31, 2025 and 2024 were $5.7 million and $7.9 million, respectively. The decrease of approximately $2.2 million primarily reflects the decrease in international promotion fees due to the decrease in international sales in 2025 in comparison to the same period in 2024, as well as lower compensation expense associated with the nonrecurrence in 2025 of certain one-time payments and equity grants that occurred in 2024 in connection with new hires.
Current wording
Selling, general and administrative (“SG&A”) expenses for the six months ended June 30, 2025 and 2024 were $11.2 million and $13.4 million, respectively. The decrease of approximately $2.2 million primarily reflects a net decrease of expenses in connection with international sales and marketing activity (mostly caused by a decrease in international promotion fees related to a combination of the amendment to the International Promotion Agreement with Meridian as well as lower international activity in 2025), as well as lower compensation expense associated with the nonrecurrence in 2025 of certain one-time payments and equity grants that occurred in 2024 in connection with new hires.
Previous wording
As of March 31, 2025, we had $162.3 million in cash and cash equivalents, compared with $155.4 million at December 31, 2024. 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 June 30, 2025, we had $182.5 million in cash and cash equivalents, compared with $155.4 million at December 31, 2024. 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 provided by/(used in) operating activities for the three months ended March 31, 2025 and 2024 was $7.1 million and ($6.1) million, respectively. For the three months ended March 31, 2025, the receipt of approximately $20 million from sales of TPOXX® to the U.S. Government and an international customer, all of which was from accounts receivable at December 31, 2024, as well as the receipt of investment income on cash and cash equivalents, was partially offset by the payment of approximately $8 million of income taxes as well as for the use of cash (net of research development revenues) for inventory and customary operating activities. For the three months ended March 31, 2024, the receipt of approximately $25 million from sales of oral TPOXX® to the U.S. Government, of which approximately $15 million relates to first quarter 2024 sales and the remainder to accounts receivable at December 31, 2023, was offset by payment of $21.8 million of income taxes as well as for the use of cash for customary operating activities.
Current wording
Net cash provided by/(used in) operating activities for the six months ended June 30, 2025 and 2024 was $70.1 million and ($0.2) million, respectively. For the six months ended June 30, 2025, the receipt of approximately $80 million from sales of TPOXX® to the U.S. Government and an international customer, $20 million from sales of TPOXX® from accounts receivable at December 31, 2024, as well as the receipt of investment income on cash and cash equivalents, was partially offset by the payment of approximately $8 million of income taxes as well as for the use of cash (net of research development revenues) for inventory and customary operating activities. 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.
Previous wording
There was minimal (less than $25,000) cash-related investing activities for the three months ended March 31, 2025 and no cash-related investing activities for the three months ended March 31, 2024.
Current wording
There was minimal (less than $25,000) cash-related investing activities for the six months ended June 30, 2025 and 2024.
Previous wording
As of March 31, 2025, we had outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $11.8 million.
Current wording
As of June 30, 2025, we had outstanding purchase orders associated with manufacturing obligations in the aggregate amount of approximately $19.3 million.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
Cost of sales and supportive services for the three months ended June 30, 2025 and 2024 were $25.6 million and $12.3 million, respectively. Such costs in 2025 are associated with the manufacture and delivery of courses of oral and IV TPOXX® to the U.S. Government under the 19C BARDA Contract, as well as the write off of $0.9 million of inventory. 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.
Current report — wording carried from elsewhere
For the six months ended June 30, 2025, revenues from product sales and supportive services were $84.9 million. Such revenues include $53.3 million of oral TPOXX® and $25.8 million of IV TPOXX® sales to the U.S. Government under the 19C BARDA Contract and $5.8 million of oral TPOXX® sales to one international country. 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.
Current report — wording carried from elsewhere
Revenues from research and development activities for the six months ended June 30, 2025 and 2024, were $3.2 million and $2.7 million, respectively. The revenues for the six months ended June 30, 2025 and 2024, were mostly earned in connection with performance of research and development activities under the 19C BARDA Contract. The increase of $0.5 million of revenue is primarily related to an increase in billable activities under the 19C BARDA Contract.
Current report — wording carried from elsewhere
Research and development (“R&D”) expenses for the six months ended June 30, 2025 and 2024 were $7.9 million and $5.9 million, respectively, reflecting an increase of approximately $2.0 million. The expense increase is primarily attributable to an increase in vendor-related research and development activity (a portion of which is funded under the 19C BARDA Contract), as well as higher expenses for the implementation of information technology enhancements, higher compensation expense in connection with an increase in headcount, and an increase in the usage of regulatory consultants.
Current report — wording carried from elsewhere
Other income, net for the six months ended June 30, 2025 and 2024 were $3.3 million and $3.3 million, respectively. These amounts reflect interest income earned on cash and cash equivalents.
Current report — wording carried from elsewhere
For the six months ended June 30, 2025 and 2024, we recorded pre-tax income of $46.7 million and $15.6 million, respectively, and a corresponding income tax provision of $11.6 million and $3.5 million, respectively. The effective tax rates during the six months ended June 30, 2025 and 2024 were 24.9% and 22.4%, respectively. Our effective tax rates for the periods ended June 30, 2025 and 2024 differ from the statutory rate primarily as a result of state taxes and non-deductible executive compensation under Internal Revenue Code Section 162(m).