Q2 2024 SIGA Technologies Inc Earnings Call
Speaker Change: Welcome to SIGA Business Update Call. Before we turn the call over to SIGA Management, please note that any forward-looking statements made during this call are based on management's current expectations and observations.
Operator: Call over to SIGA Management. Please note that any forward-looking statements made during this call are based on management's current expectations and observations, and are subject to risks and uncertainties that could cause actual results to differ from the forward-looking statements. SIGA does not undertake any obligations to update publicly any forward-looking statement to reflect events or change circumstances after this call.
Operator: and SIGA Management, please note that any forward-looking statements made during this call are based on management's current expectations and observations. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or change circumstances after this call. For a discussion of factors that could cause results to differ, please see the company's filings with the Securities and Exchange Commission, including without limitation the company's annual report on Form 10-K. With that, I will turn the call over to Zem Nguyen, Chief Executive Officer of SIGA.
Speaker Change: and are subject to risks and uncertainties that could cause actual results to differ from the forward-looking statements.
Speaker Change: SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or change circumstances after this call.
Operator: For discussion of factors that could cause results to differ, please see the company's filings with the Securities and Exchange Commission, including, without limitation, the company's annual report on Form 10-K. For the year ended December 31st, 2023, and its subsequent reports on Form 10-K and Form 8-K.
Speaker Change: For a discussion of factors that could cause results to differ, please see the company's filings with the Securities and Exchange Commission, including, without limitation, the company's annual report on Form 10-K .
Zem Nguyen: For the year ended December 31st, 2023 and its subsequent reports on Form 10-Q and Form 8-K. With that, I will turn the call over to Zem Nguyen, Chief Executive Officer of SIGA.
Operator: With that, I will turn the call over to Zem Wen, Chief Executive Officer of SIGA.
Zem Nguyen: Product revenues for the three and six months ended June 30, 2024, were $21,045,000, respectively. This surpassed product revenues of $1,007,000, respectively, for the period in 2023. These strong results are reflective of SIGA's staying power. Our capital management activity over the past several years, including substantial special cash dividends, reflects and has been made possible by this strong long-term performance. Our sales reflect a diverse mix of oral-TPoX deliveries to the U.S. Strategic National Stockpile, or S&S, the U.S. Department of Defense, and 11 international customers, as well as IV-TPoX deliveries to the S&S.
Zem Wen: Zem. Good afternoon, everyone, and thank you for joining today's call and the review of our business results for the second quarter of 2024. I am joined by Dan Luckshire, our Chief Financial Officer, and we appreciate this opportunity to provide an update on our company.
Zem Nguyen: Good afternoon, everyone, and thank you for joining today's call and the review of our business results for the second quarter of 2024. I am joined by Dan Luckshire, our Chief Financial Officer, and we appreciate this opportunity to provide an update on our company.
Zem Wen: After the update, we'll be happy to answer your questions. I am pleased to report that SIGA has continued to generate product revenues that outpaced revenues in the comparable periods last year. Product revenues for the three and six months, and in June 30th, 2024, were $21 million and $45 million, respectively. This surpassed product revenues of $1 million and $7 million, respectively, for the periods in 2023. These strong results are reflective of SIGA's staying power. Our capital management activity over the past several years, including substantial special cash dividends, reflects and has been made possible by this strong long-term performance.
Zem Nguyen: After the update, we'll be happy to answer your questions.
Zem Nguyen: I am pleased to report that SIGA has continued to generate product revenues that outpace revenues in the comparable periods last year.
Zem Nguyen: Product revenues for the 3 and 6 months ended June 30, 2024 were $21,045,000, respectively. This surpassed product revenues of $1,007,000, respectively, for the periods in 2023.
Zem Nguyen: These strong results are reflective of SIGA's staying power. Our capital management activity over the past several years, including substantial special cash dividends, reflects and has been made possible by the strong long-term performance.
Zem Wen: Our focus on long-term performance is critical due to the nature of SIGA's business and then hair quarter-over-quarter fluctuations. We believe the financial results for the first six months of 2024 supports an important positive long-term trend. Our style reflects a diverse mix of oral T-Pock deliveries to the U.S. strategic national stockpile or SMS, the U.S. Department of Defense and 11 international customers, as well as IV T-Pock deliveries to the SMS. Looking ahead, we anticipate a continued diversification of our revenue base will be important for maximum long-term performance. Consistent with what we said last quarter, we expect 2024 to be another year of strong product revenues.
Zem Nguyen: Our focus on long-term performance is critical due to the nature of SIGA's business and the inherent quarter-over-quarter fluctuations.
Zem Nguyen: We believe the financial results for the first six months of 2024 supports an important positive long-term trend.
Speaker Change: Our sales reflect a diverse mix of oral teapot deliveries to the U.S. Strategic National Stockpile, or SMS,
Zem Nguyen: The U.S. Department of Defense and 11 international customers
Zem Nguyen: as well as IV-APOC's delivery to the S&S. Looking ahead, we anticipate a continued diversification of our Revenant Base will be important for maximum long-term performance.
Zem Nguyen: Consistent with what we said last quarter, we expect 2024 to be another year of strong product revenues. As a reminder, our 2023 product revenues were the highest achieved over the past five years.
Zem Wen: As a reminder, our 2023 product revenues were the highest achieved over the past five years. Two weeks ago, the U.S. government exercised its procurement option under the 19th seed barter contract for the delivery of approximately 113 million of oral T-Pock. We plan to work with the U.S. government on the timing of delivery and currently anticipate deliveries will begin within the next 90 days. We foresee a meaningful portion of this order will be delivered before your end, supporting our expectation that product revenues will again be substantial this year. There's our view that this award illustrates the U.S.
Zem Nguyen: Looking ahead, we anticipate a continued diversification of our revenue base will be important for maximum long-term performance. Two weeks ago, the U.S. government exercised its procurement option under the 19C BARDA contract for the delivery of approximately 113 million oral teapots.
Speaker Change: Two weeks ago, the U.S. government exercised its procurement option under the 19C BARDA contract for the delivery of approximately 113 million of oral teapots.
Speaker Change: We plan to work with the U.S. government on the timing of delivery and currently anticipate deliveries will begin within the next 90 days.
Zem Nguyen: We foresee that a meaningful portion of this order will be delivered before year-end. Supporting our expectation that product revenues will, again, be substantial this year is our view that this award illustrates the U.S. government's belief that smallpox continues to be a threat. Over 1,500 MPOCS patients have been enrolled in clinical trials to assess the efficacy of TPOCS for the treatment of MPOCS, utilizing TPOCS and its matching placebo provided by SIGA to trial sponsors at no cost.
Speaker Change: We foresee a meaningful portion of this order will be delivered before year-end, supporting our expectation that product revenues will, again, be substantial this year. It is our view that this award illustrates the U.S. government's belief that smallpox continues to be a threat.
Zem Wen: government's belief that smallpox continues to be a threat. It also demonstrates its ongoing commitment to maintaining a robust stockpile of small-pots anti-virus to help ensure the health security of American people and an issue that is consistently garnered by power and support. T-Pox has a strong safety profile based upon pre-clinical safety and toxicology data, based on clinical data and health volunteers, as well as clinical observations. Over 1,500 M-Pox patients have been enrolled in clinical trials to assess the efficacy of T-Pox for the treatment of M-Pox, utilizing T-Pox and its matching placebo provided by SIGA to trial sponsors at no cost.
Speaker Change: It also demonstrates its ongoing commitment to maintaining a robust stockpile of smallpox antivirals to help ensure the health security of American people and an issue that has consistently garnered bipartisan support.
Speaker Change: TPOCS has a strong safety profile based upon preclinical safety and toxicology data, phase 3 clinical data and healthy volunteers as well as clinical observations.
Speaker Change: Over 1,500 MPOCS patients have been enrolled in clinical trials to assess the efficacy of TPOCS for the treatment of MPOCS, utilizing TPOCS and its matching placebo provided by SIGA to trial sponsors at no cost.
Zem Wen: As a result, we anticipate it will be a preferred anti-vial treatment in an event of an outbreak. Our attention is now firmly set on securing the next procurement contract with the U.S. government. Our team continues to be actively engaged with a broad range of government officials as we prepare for request for a proposal, or RFP, which can be issued by the Administration of Strategic Preparedness and Response at any time. While we wait for this next RFP, there are a number of factors that give us confidence. First, earlier this year, Congress approved the budget for the U.S.
Speaker Change: As a result, we anticipate it will be a preferred antiviral treatment in an event of an outbreak.
Speaker Change: Our attention is now firmly set on securing the next procurement contract with the U.S. government.
Speaker Change: Our team continues to be actively engaged with a broad range of government officials as we prepare for Request for Proposal, or RFP, which can be issued by the Administration of Strategic Preparedness and Response at any time.
Zem Nguyen: While we wait for this next RP, there are a number of factors that give us confidence. Second, the current public health environment, including the CLAID-1 impacts outbreak in the Democratic Republic of Congo, or the DRC, highlights the heightened pandemic risk and continued need for nations to be response ready. This includes the timely procurement of effective therapies like TPOP. And third, we have a long-standing partnership with the U.S. government to provide a critical countermeasure against one of the world's most dangerous viruses. As a reminder, smallpox is one of only six diseases considered a Category A threat by the CDC, and herd immunity is waning among our population.
Speaker Change: While we wait for this next RP, there are a number of factors that give us confidence.
Zem Wen: government, which includes another substantial increase in the federal budget for countermeasures, including the SNS. This funding outcome underscores the government's ongoing commitment to preparedness and response. Second, the current public health environment, including the Clade-1 M-pox outbreak in the Democratic Republic of Congo or the DRC, highlights the heightened pandemic risks and continued need for nations to be response-ready. This includes a timely procurement of effective therapies like T-Pox. And third, we have a long-standing partnership with the U.S. government to provide a critical countermeasure against one of the world's most dangerous virus threats. As a reminder, smallpox is one of only six diseases considered a Category A threat by the CDC, and herd immunity is waiting among our populations.
Speaker Change: First, earlier this year, Congress approved the budget for the U.S. government, which includes another substantial increase in the federal budget for countermeasures, including the S&S. This funding outcome underscores the government's ongoing commitment to preparedness and response.
Speaker Change: Second, the current public health environment, including the CLAID-1 impacts outbreak in the Democratic Republic of Congo or the DRC, highlights the heightened pandemic risk and continued need for nations to be response ready.
Speaker Change: This includes the timely procurement of effective therapies like T-PoX.
Speaker Change: And third, we have a longstanding partnership with the U.S. government to provide a critical countermeasure against one of the world's most dangerous biothreats.
Speaker Change: As a reminder, smallpox is one of only six diseases considered a Category A threat by the CDC, and herd immunity is waning among our population.
Zem Nguyen: In fact, TPOX was among the first novel small cell therapy delivered to the SNS under Project BioShield and was developed in collaboration with BARDA. All in all, based on our conversations with government officials, as well as other SMS contracts to procure medical countermeasures, we are confident that the government is receptive to a new, long-dated contract, most likely between 5 and 10 years, and the aggregate value of this contract should surpass the aggregate value of our current contract, under which most options have now been exercised. Dan will provide further details on our financial position shortly. In summary, our balance sheet is robust with no debt, our cash flow remains strong, and we have exercised prudent cash management.
Zem Wen: In fact, T-Pox was among the first novel smallpox therapy delivered to the SNS under Project BioShield and was developed in collaboration with BARDA. All in all, based on our conversations with the government officials, as well as other SNS contracts to procure medical countermeasures, we are confident that the government is receptive to a new long-dated contract, most likely between five and ten years. And the aggregate value of this contract should surpass the aggregate value of our current contract, under which most options have now been exercised. As a frame of reference, the current 19-C BARDA contract signed in 2018 has a procurement value of $546 million.
Speaker Change: In fact, TPOX was among the first novel small molecule therapy delivered to the SNS under Project BioShield and was developed in collaboration with BARDA.
Speaker Change: All in all, based on our conversations with the government officials, as well as other SMS contracts to procure medical countermeasures, we are confident that the government is receptive to a new, long-dated contract.
Speaker Change: Most likely between 5 and 10 years.
Speaker Change: And, the aggregate value of this contract should surpass the aggregate value of our current contract, under which most options have now been exercised.
Speaker Change: As a frame of reference, the current 19C BARDA contract signed in 2018 has a procurement value of $546 million. This is an exciting time for SIGA. As I said earlier, the health and security of Americans is an issue that continues to garner bipartisan support.
Zem Wen: This is an exciting time for CEDA. As I said earlier, the health and security of Americans is an issue that continues to garner bipartisan support. So while we wait for the receipt of this, our next RFP, we are keeping our focus on our longer term goals. We have the financial strength to advance our business with current and potential customers outside the U.S., while remaining ready to collaborate with the U.S. government once it initiates the RFP process. Daniel will provide further details on our financial position shortly. In summary, our balance sheet is robust, with no debt.
Speaker Change: So while we wait for the receipt of this, our next RFP, we are keeping our focus on our longer-term goals.
Speaker Change: We have the financial strength to advance our business with current and potential customers outside the U.S. while remaining ready to collaborate with the U.S. government once it initiates the RFP process.
Speaker Change: Dan will provide further details on our financial position shortly. In summary, our balance sheet is robust with no debt, our cash flow remains strong, and we have exercised prudent cash management. This allows us to recently pay a special cash dividend in April .
Zem Wen: Our cash flow remains strong, and we have exercised prudent cash management. This allows us to recently pay a special cash dividend in April.
Zem Nguyen: This allowed us to recently pay a special cash dividend in April. Moving on, we've also made progress in several other key areas. In April, we announced an amendment to our International Promotion Agreement with Meridian Medical Technologies, under which SIGA began driving promotional activities outside the U.S. for oral teapots starting June 1. In June, we announced an agreement to sell teapots to the member states in the Association of Southeast Asian Nations.
Zem Wen: Moving on, we've also made progress in several other key areas. In April, we announced an amendment to our International Promotion Agreement with Meridian Medical Technologies, under which SIGA began driving promotional activities outside the US for oral teapots starting June 1st. Since then, our team has strengthened relationships with pre-global customers, and we are confident these efforts will lead to growth over time. In June, we announced an agreement to sell teapots to the Member States and the Association of Southeast Asian Nations. This agreement is a foundational step in a highly populated region for strong collaboration in the future.
Speaker Change: Moving on we've also made progress in several other key areas. In April we announced an amendment to our International Promotion Agreement with Meridian Medical Technologies under which SIGA began driving promotional activities outside the U.S. for oral teapots starting June 1st.
Speaker Change: Since then, our team has strengthened relationships with key global customers, and we are confident these efforts will lead to growth over time.
Speaker Change: In June , we announced an agreement to sell teapots to the member states in the Association of Southeast Asian Nations. This agreement is a foundational step in a highly populated region for strong collaboration in the future.
Zem Nguyen: This agreement is a foundational step in a highly populated region for strong collaboration in the future. Based upon the standard review timeline for the new drug application, we expect a final regulatory decision by early next year. The trial was designed to test this drug-vaccine combination and ensure there'd be no impact on patient safety or vaccine immunogenicity.
Zem Wen: In Japan, we continue to have productive conversations with our partners, to tan by a techno farmer, and regulators on the new drug application for teapots for the treatment of smallpox, mpox, catpox, and complications due to the vicinity of virus. Based upon the standard review timeline for the New Drug Application, we expect a final regulatory decision by early next year. If we prove, we anticipate that teapots will replace a national stockpile right next year. We continue to pursue the expansion of teapots' approvals in new indications such as pet and mpox informulations. First, on pet, as I stated before, we believe that teapots has a potential benefit against smallpox and a post-exposure prophylaxis.
Speaker Change: In Japan, we continue to have productive conversations with our partner, Japan Biotechnology Pharma, and regulators on the new drug application for T-pox for the treatment of smallpox, m-pox, cowpox, and complications due to the Vicinia virus.
Speaker Change: Based upon the standard review timeline for the new drug application, we expect a final regulatory decision by early next year. If approved, we anticipate that TPOX will be placed in national stockpiles ready for deployment in the event of an outbreak.
Speaker Change: We continue to pursue the expansion of TPOCS approvals and new indications such as PEP and MPOCS and formulations.
Speaker Change: First, on PEP, as I stated before, we believe that T-pox has a potential benefit against smallpox and a post-exposure prophylaxis.
Zem Wen: Currently, most of much of our work has been focused in the completed teapots' genio safety and immunogenicity trial to evaluate teapots when administered together with genio. As a reminder, this trial was requested by the FDA because of the likely use of teapots' ingenios together in events of an outbreak. The trial was designed to test this drug vaccine combination and ensure there would be no impacts to patient safety or vaccine immunogenicity. As a reminder, the data for the trial is supportive of the safety objective. Regarding immunogenicity, we are continuing to work with the CDC in consultation with the FDA to complete an analysis of samples collected to support the immunogenicity objective.
Speaker Change: Currently most of much of our work has been focused in the completed TPOX GENIOS safety and immunogenicity trial to evaluate TPOX when administered together with GENIOS.
Speaker Change: As a reminder, this trial was requested by the FDA because of the likely use of TPOX and JYNNEOS together in the event of an outbreak.
Speaker Change: The trial was designed to test this drug-vaccine combination and ensure there would be no impact to patient safety or vaccine immunogenicity.
Speaker Change: As a reminder, the data from the trial is supportive of the safety objective.
Zem Nguyen: Regarding immunogenicity, we are continuing to work with the CDC in consultation with the FDA to complete an analysis of samples collected to support the immunogenicity objective. At the same time, we are working out our supplemental NDA submission and targeting submitting it within the next 12 months. The NIA POM 007 trial in the DRC has now completed enrollment, and we anticipate release of top-line data in the coming weeks. MPOC remains a global threat, and particularly in the DRC, where cases continue to rise.
Speaker Change: Regarding immunogenicity, we are continuing to work with the CDC in consultation with the FDA to complete an analysis of samples collected to support the immunogenicity objective.
Zem Wen: At the same time, we are working out our supplemental NDA submission and targeting submitting it within the next 12 months. Turning to the ongoing mpox trial, the trial sponsors continue to make significant progress. The NIA POM-007 trial in the DRC has now completed enrollment. We anticipate release of top-line data in the coming weeks. The NIA stop trial has been considerable growth with 515 patients are rolled as of July, up from 350 reported from our last call. Mpox remains a global threat and particularly in the DRC where cases continue to rise. To support investigators of health agencies in 2022, we dated over 500 courses of teapots capsules and its corresponding police placebo for the randomized clinical trial POM-007.
Speaker Change: At the same time, we are working on our supplemental NDA submission and targeting submitting it within the next 12 months.
Speaker Change: Turning to the ongoing MPOC trial, the trial sponsors continue to make significant progress.
Speaker Change: The NIA POM 007 trial in the DRC has now completed enrollment. We anticipate release of top-line data in the coming weeks.
Speaker Change: The DIAID STOP trial has seen considerable growth, with 515 patients enrolled as of July , up from 350 reported from our last call.
Speaker Change: MPOC remains a global threat and particularly in the DRC where cases continue to rise.
Zem Nguyen: To support investigators and health agencies, in 2022, we donated over 500 courses of TPOC capsules and its corresponding placebo for the randomized clinical trial POM-007. Recently, we donated another 100 courses to ensure patient access continues during data analysis. In summary, our company is strong, profitable, and well-positioned for the future, and it is supported by the following four pillars. Number one, we have a well-practiced strategy that is yielding results. Two, we have a prudent approach to capital management which has afforded us the opportunity to pay significant special cash dividends. With that, I'll turn over to Dan to review the financial results in more detail.
Speaker Change: To support investigators and health agencies, in 2022, we donated over 500 courses of TPOC capsules and its corresponding placebo for the randomized clinical trial POM-007.
Zem Wen: Recently, we donated another hundred courses into our patient access continues during data analysis. We're also working to support broader access programs in Africa. Additionally, the US government has distributed approximately 40,000 courses of the T-POPs in response to the 2022 M-POPs outbreak through the CDC's compassionate use program. We continue to monitor the situation actively, providing assistance when possible to see the best possible outcomes for M-POPs.
Speaker Change: Recently, we donated another 100 courses to ensure patient access continues during data analysis.
Speaker Change: We're also working to support broader access programs in Africa.
Speaker Change: Additionally, the U.S. government has distributed approximately 40,000 courses of TPOPS in response to the 2022 MPOPS outbreak through the CDC's Compassionate Use Program.
Speaker Change: We continue to monitor the situation actively, providing assistance, when possible, to achieve the best possible outcomes for MPOC patients.
Zem Wen: In summary, our company is strong, profitable, and well-positioned for the future and supported by the following four pillars. Number one, we have a well-crafted strategy that is yielding results. Two, we have a prudent approach to capital management, which has afforded us the opportunity to pay significant special cash dividends. We have a valuable T-POPs franchise that fulfills our critical requirement established by the US government. To share the country is prepared in the event of a natural, accidental, or intentional outbreak. And four, we have a resilient team with proven operational capabilities to our executing honor strategy with urgency and effectiveness.
Speaker Change: In summary, our company is strong, profitable, and well-positioned for the future and supported by the following four pillars. Number one, we have a well-crafted strategy that is yielding results.
Speaker Change: Two, we have a prudent approach to capital management which has afforded us the opportunity to pay significant special cash dividends.
Speaker Change: We have a valuable teapot franchise that fulfills our critical requirement established by the U.S. government.
Speaker Change: to ensure the country is prepared in the event of a natural, accidental, or intentional outbreak. And, four, we have a resilient team with proven operational capabilities who are executing on our strategy with urgency and effectiveness.
Zem Wen: Combined, we believe these pillars will enhance shareholder value over time and approve public health.
Speaker Change: Combined, we believe these pillars will enhance shareholder value over time and improve public health. With that, I'll turn it over to Dan to review the financial results in more detail.
Daniel Luckshire: With that, I'll turn over to Dan to review the financial results in more detail. Thanks, Sam. As noted earlier in the call, DIGA's product revenues through the three and six months ended June 30th, 2024, were $21 million and $45 million, respectively, which surpasses product revenues of $1 million and $7 million, respectively, for the comparable periods last year. Product revenues through the quarter were primarily related to approximately $18 million of IV T-POPs sales to the U.S. government. For the six months ended June 30th, 2024, product revenues reflected a diverse mix, including approximately $15 million of oral T-POPs sales to the US government under the 19-C contract, approximately $11 million of international oral T-POPs sales to the 11 countries, approximately $1 million oral T-POPs sales to the US Department of Defense, and the previously mentioned approximately $18 million IV T-POPs sales to the US government.
Dan: Thanks, Sam. As noted earlier in the call, SIGA's product revenues through the three and six months ended June 30, 2024, for $21 million and $45 million, respectively.
Dan: which surpasses product revenues of 1 million dollars and 7 million dollars respectively for the comparable periods last year.
Dan: Product revenues for the quarter were primarily related to approximately 18 million dollars of IV teapot sales to the U.S. government.
Dan: For the six months ended June 30th, 2024, product revenues reflected diverse mix.
Dan: including approximately $15 million of oil teapot sales to the U.S. government under the 19C contract and approximately $11 million of international oral teapot sales to 11 countries for the three and six months into June 30th, 2024, respectively.
Dan: including approximately 15 million dollars of oil teapot sales to the US government under the 19c contract
Dan: Approximately 11 million dollars of international oral teapot sales to 11 countries. Approximately 1 million dollars of oral teapot sales to the U.S. Department of Defense and the previously mentioned approximately 18 million dollars of IV teapot sales to the U.S. government.
Daniel Luckshire: In addition, the product revenues, the company had research and development revenues of approximately $1 million and $3 million for the three and six months ended June 30th, 2024, respectively. Pre-tax operating income, which excludes interest income and taxes, was approximately $1 million with the three months ended June 30th, 2024. For the six months ended June 30th, pre-tax operating income was approximately $12 million. In comparison, there was a pre-tax operating loss for the three and six months ended June 30th, 2023, of approximately $5 million and $7 million, respectively. That income for the three months ended June 30th, 2024, was approximately $2 million.
Dan: In addition to product revenues, the company had research and development revenues of approximately $1 million and $3 million.
Dan: 4 to 3 and 6 months end of June 30th, 2024, respectively.
Dan: Pre-tax operating income, which excludes interest income and taxes, was approximately $1 million for the three months ended June 30, 2024. For the six months ended June 30, pre-tax operating income was approximately $12 million. In comparison, there was a pre-tax operating loss for the three and six months ended June 30, 2023 of approximately $5 million and $7 million, respectively. In turn, fully diluted income per share for the three months ended June 30, 2024 was $0.03 per share.
Dan: Pre-tax operating income, which excludes interest income and taxes, was approximately $1 million for the three months ended June 30, 2024. For the six months ended June 30, pre-tax operating income was approximately $12 million.
Dan: In comparison, there was a pre-tax operating loss for the three and six months ended June 30, 2023 of approximately $5 million and $7 million, respectively.
Dan: Net income for the three months ended June 30, 2024 was approximately $2 million.
Daniel Luckshire: For the six months ended June 30th, that income was approximately $12 million. In turn, Pollate diluted income per share for the three months ended June 30th, 2024, was three cents per share. And for the six months ended June 30th, Pollate diluted income per share was 17 cents. At June 30th, 2024, the company continued to maintain a strong balance sheet for the cash bounce of approximately $107 million in no debt. On April 11th, DIGA paid the previously disclosed special cash dividend of $0.60 per share, which amounted to an approximately $43 million payment to shareholders. Looking forward, as Zen mentioned earlier in the call, we are working diligently to continue our positive momentum.
Dan: For the six months ended June 30th that income was approximately 12 million dollars
Dan: In turn, fully diluted income per share for the three months ended June 30, 2024 was $0.03 per share, and for the six months ended June 30, fully diluted income per share was $0.17.
Dan: And for the six months ended June 30, fully diluted income per share was $0.17. As of June 30, 2024, the company continued to maintain a strong balance. On April 11th, SIGA paid the previously disclosed special cash dividend of $0.60 per share, which amounted to an approximately $43 million payment to shareholders. Looking forward, as Zem mentioned earlier in the call, we are working diligently to continue our positive momentum. As such, we believe 2024 is lining up to be another year of strong product revenue performance.
Dan: At June 30, 2024, the company continued to maintain a strong balance sheet with a cash balance of approximately $107 million and no debt.
Dan: On April 11th, SIGA paid the previously disclosed special cash dividend of $0.60 per share, which amounted to an approximately $43 million payment to shareholders.
Dan: Looking forward, as then mentioned earlier in the call, we are working diligently to continue our positive momentum.
Daniel Luckshire: As such, we believe 2024 is lining up to be another year of strong product-revenue performance.
Dan: As such, we believe 2024 is lining up to be another year of strong product revenue performance.
Daniel Luckshire: This concludes the financial update.
Zem Wen: At this point, I will turn the call back to Zen. Thanks, Dan. Leveraging our achievements from 2023 and the possible momentum generated so far this year, we believe SIGA is poised for continued growth and innovation. We remain focused on advancing our strategic goals, including securing a new contract with the US government, optimal capital management, and enhancing our T-Pox franchise. We are confident this will deliver the value to our patients, partners, and shareholders over time.
Dan: This concludes the financial update. At this point, I will turn the call back to Zim.
Zem Nguyen: Thanks, Dan. Leveraging our achievements from 2023 and the positive momentum generated so far this year, we believe SIGA is poised for continued growth and innovation. We remain focused on advancing our strategic goals, including securing a new contract with the U.S. government.
Zim: Thanks, Dan. Leveraging our achievements from 2023 and the positive momentum generated so far this year, we believe SIGA is poised for continued growth and innovation. We remain focused on advancing our strategic goals, including securing a new contract with the U.S. government.
Speaker Change: Optimal Capital Management and Enhancing our TPoS Franchise
Zim: We are confident this will deliver value to our patients, partners, and shareholders over time.
Operator: Now, I would like to open the call to Q&A operator.
Speaker Change: Now I would like to open the call to Q&A. Operator?
Dennis Hruby: and Dennis Hruby. I hope you enjoyed the video. If you did, please give it a thumbs up and subscribe to my channel.
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Speaker Change: Hello?
Soo Romanoff: Yes. Hi, sorry. I had some technical difficulties here. Thank you for taking my question. Congratulations on another strong quarter.
Speaker Change: Yes.
Speaker Change: Hi, sorry, I had some technical difficulties here. Thank you for taking my question. Congratulations on another strong quarter.
Soo Romanoff: I have a multi-part question, and these are mostly just the ones that have gone a little more color. It sounds like you've delivered—it was nice to hear the 113 million Barta exercise with the remaining part of oral T-Pox come across. It sounds like you're going to deliver a meaningful portion in 2024, despite the manufacturing bottlenecks. Any more color on the timeline would be helpful. The second part would be—did you provide a sense of when Barta will exercise the remaining 26 million IV T-Pox? I believe the July 23 IV T-Pox order was yet to be delivered, and the last part is—could you provide an update on the US government negotiations?
Speaker Change: I have a multi-part question and these are mostly just to garner a little more color. It sounds like you've delivered, it was nice to hear the 113 million BARDA exercise for the remaining part of oral T-pox come across.
Speaker Change: It sounds like you're going to deliver a meaningful portion in 2024, despite the manufacturing bottlenecks.
Unknown Shareholder: It sounds like you're going to deliver a meaningful portion in 2024 despite the manufacturing bottlenecks. Any more color on the timeline would be helpful. The second part would be, could you provide a sense of when BARDA will exercise the remaining 26 million IV TPOCs? I believe the July 23 IV TPOC order was yet to be delivered. And the last part is, could you provide an update on the U.S. government negotiations? I believe we're looking at some kind of recurring arrangement.
Speaker Change: Any more color on the timeline would be helpful. The second part would be, could you provide a sense of when BARDA will exercise the remaining 26 million IV TPOCs?
Speaker Change: I believe the July 23 IV T-PoX order was yet to be delivered. And the last part is, could you provide an update on the U.S. government negotiations? I believe we're looking at some kind of recurring arrangement.
Soo Romanoff: I believe we're looking at some kind of recurring arrangement. Thank you, Soo.
Zem Wen: If you can hear me, I'm going to try to tackle your questions in three parts. The first question relates to the recent barter exercise of our remaining option and when do we anticipate the delivery. And what I would state here is that we've been proactively coordinating with our supply chain in preparation for the U.S. government's exercise of this option under the current barter contract. And we are working with our partners to produce and deliver oral teapots on schedule that makes sense for our customer, the U.S. government. We are confident in our ability to deliver and expect to start shipping within the next 90 days, with a meaningful portion of this to be delivered this year.
Speaker Change: Thank you, Soo. If you can hear me, I'm going to try to tackle your questions in three parts.
Zem Nguyen: The first question relates to the recent barter exercise of our remaining option and when do we anticipate delivery? We are working with our partners to produce and deliver oral teapots on a schedule that makes sense for our customer, the U.S. government. We are confident in our ability to deliver and expect to start shipping within the next 90 days, with a meaningful portion of this to be delivered this year. We are collaborating with the U.S. government to determine the optimal timing and, therefore, cannot be more specific at this time.
Speaker Change: The first question relates to the recent barter exercise of our remaining option and when do we anticipate the delivery?
Speaker Change: And what I would state here is that we've been proactively coordinating with our supply team in preparation for the U.S. government's exercise of this option under the current BARDA contract.
Speaker Change: And we are working with our partners to produce and deliver oral teapots on schedule that make sense for our customer, the U.S. government.
Speaker Change: We are confident in our ability to deliver and expect to start shipping within the next 90 days with a meaningful portion of this to be delivered this year. We are collaborating with the U.S. government to determine the optimal timing and therefore cannot be more specific at this time.
Zem Wen: We are collaborating with the U.S. government to determine the optimal timing and therefore cannot be more specific at this time.
Zem Wen: As it relates to your second question, you had asked about the IV teapot's option. And just to give you a little bit of background, the 18 million that was discussed today of the IV teapot's sales in the second quarter relates to the 2022 order. Once we finish this 2022 order, we will then coordinate with the U.S. government and our supply chain on the timeline for producing and delivering on the 2023 order. Based on what we know today, we do anticipate the barter will exercise the final 26 million option in 2025.
Zem Nguyen: As it relates to your second question, you asked about the IV T-POX option. And just to give you a little bit of background, the $18 million that was discussed today for the IV TPOC sales in the second quarter relates to the 2022 order. Once we finish this 2022 order, we will then coordinate with the U.S. government and our supply chain on the timeline for producing and delivering on the 2023 order. From these conversations, there is clear bipartisan support for helping to ensure the health security of the American people.
Speaker Change: As it relates to your second question, you had asked about the IV T-POX option.
Speaker Change: And just to give you a little bit of background, the $18 million that was discussed today of the IV TPOC sales in the second quarter relates to the 2022 order.
Speaker Change: Once we finish this 2022 order, we will then coordinate with the U.S. government and our supply chain on the timeline for producing and delivering on the 2023 order.
Speaker Change: Based on what we know today, we do anticipate that BARDA will exercise the final $26 million option in 2025.
Zem Wen: I guess the last question that you had was an update on the U.S. Government negotiations. As we mentioned during our prepared remarks, we have been having discussions with a broad range of government officials. From these conversations, there is a clear bipartisan support in helping to ensure the health security of the American people. And given the increased geopolitical risk globally and the MPAC's outbreak in the DRC, we are prepared to respond when Asper is ready for the start of that RFP process. As mentioned, our aim is to hear a long-term contract with more regular purchases, and that this contract reflects the value of teapots that's provided today as well as in the future.
Speaker Change: I guess the last question that you had, Soo, was an update on the U.S. government negotiations. As we mentioned during our prepared remarks, we have been having discussions with a broad range of government officials.
Speaker Change: From these conversations, there is a clear bipartisan support in helping to ensure the health security of the American people.
Speaker Change: And given the increased geopolitical risk globally and the Mpox outbreak in the DRC, we are prepared to respond when ASPR is ready for the start of that RFP process.
Speaker Change: As mentioned, our aim is to secure a long-term contract with more regular purchases and that this contract reflects the value of TPOCs that's provided today as well as in the future.
Soo Romanoff: We do believe the U.S. government is open to a long-term contract, potentially up to 10 years, and one with a higher aggregate value than the 2018 contract. That's great.
Speaker Change: We do believe the U.S. government is open to a long-term contract, potentially up to 10 years, and one with a higher aggregate value than the 2018 contract.
Unknown Shareholder: That's great. If you don't mind, it's good to see that, you know, there's a lot more interest, I mean, with the recent Asian country agreement for oral teapots. We touched on this a little bit, but any clarity on the size timelines would be helpful. And then also, I know you're working with Meridian at some kind of,
Soo Romanoff: If I can ask one more question, if you don't mind. Sure. It's good to see that there's a lot more interest, I mean with the recent Asian country agreement for oral teapots. We touched on this a little bit, but any clarity on the size, timelines would be helpful. And then also, I know you're working with Meridian at any kind of color on the fee structure economics for this new order would be kind of nice too. Sure. I'll talk about the Asian agreement, and then you can highlight in terms of the Meridian economics. First, I want to really highlight that we are incredibly pleased with this...
Speaker Change: Joe Stewart, Unknown Executive, Phillip Gomez, Diem Nguyen, Dennis Hruby
Speaker Change: That's great. If I can ask one more question, if you don't mind.
Speaker Change: [inaudible]
Speaker Change: It's good to see that, you know, there's a lot more interest, I mean, with the recent Asian country agreement for oral teapots.
Speaker Change: We touched on this a little bit, but any clarity on the size timelines would be helpful. And then also, I know you're working with Meridian. Any kind of
Speaker Change: Color on the fee structure economics for this new order would be kind of nice too.
Zem Nguyen: Sure, I'll talk about the ASEAN agreement, and Dan can give his opinion on Meridian economics. First, I want to really highlight that we are incredibly pleased with this agreement, which was signed in June. This agreement further advances our strategy to expand access to TPOC to even more international markets. Contracts represent an important step to growing orthopox virus preparedness in the Asia region, and it has established a footprint in a highly populated region.
Speaker Change: Sure, I'll talk about the ASEAN agreement and Dan you can highlight in terms of the Meridian Economics. First, I want to really highlight that we are incredibly pleased with this agreement, which was signed in June .
Zem Wen: Agreement, which was signed in June. This agreement further advances our strategy to expand access to T-POPs to even more international markets. Asia is a strategic region for SIGA. This contract represents an important step to growing or the POPs virus preparedness in the Asia region and that establish a footprint in a highly populated region. It also sets the groundwork for additional activity for the teacher. As we noted in our June release, we did receive 3 million orders from a new customer in the ASEAN region. We believe this is the first important step to larger collaboration, as the ASEAN member states together represent a population of over 600 million people with a GDP of over $3.6 trillion.
Speaker Change: This agreement further advances our strategy to expand access to teapots to even more international markets.
Speaker Change: Asia is a strategic region for SIGA. This contract represents an important step to a growing orthopox virus preparedness in the Asia region and does establish a footprint in a highly populated region.
Speaker Change: It also sets the groundwork for additional activity for the future.
Zem Nguyen: As we noted in our June release, we did receive a 3 million order from a new customer in the ASEAN region. We believe this is the first important step to larger collaboration as the ASEAN member states together represent a population of over 600 million people with a GDP of over $3.6 trillion. We have not disclosed the financial terms to date, however, as we have emphasized, we're quite optimistic with this collaboration.
Speaker Change: As we noted in our June release, we did receive 3 million order from a new customer in the ASEAN region. We believe this is the first important step to larger collaboration as the ASEAN member states together represent a population of over 600 million.
Speaker Change: people with a GDP of over $3.6 trillion. And we have not disclosed the financial terms to date. However, as we have emphasized, we're quite optimistic with this collaboration.
Daniel Luckshire: We have not disclosed the financial terms to date; however, as we have emphasized, we are quite optimistic with this collaboration.
Daniel Luckshire: Dan, would you like to talk about the Meridian amendment? Yes, certainly. So, we disclosed the original amendment earlier in the early June time frame. With that, what it did was really allow us to take over the leadership of the international marketing and relationships. With the amendment, the goal was to ensure a very, very smooth and off for the next period of time. With that, there were some key countries and regions that we wanted to ensure, especially for the handoff. That really concentrated in your Australia and Japan. So, it's much more limited in scope than the prior arrangement.
Dan: Yes, certainly. So with, we disclosed the original amendment.
Dan: Dan, would you like to talk about the Meridian Amendment?
Dan: Yes, certainly. So, we disclosed the original amendment.
Dan: earlier in the early June time frame and with that what it did was it really allowed us to take over ownership of the international marketing and relationships.
Speaker Change: With the amendment, the goal was to ensure a very, very smooth handoff for the next period of time. So with that, there were some key countries and regions.
Speaker Change: And we wanted to ensure, especially for the handoff, and that really concentrated in Europe , Australia, and Japan.
Speaker Change: So it's much more limited in scope.
Daniel Luckshire: In addition, the fee is materially lower than the original fee. We do not disclose the original fee, but it is materially lower, and the current fee is in the high single digits. That's great.
Speaker Change: than the prior arrangement. In addition, the fee is materially lower than the original fee. We do not disclose the original fee, but it is materially lower, and the current fee is in the high single digits.
Soo Romanoff: If you don't mind, if we can touch on the new impact strain in the DRC, I know you touched on this also. It seems like the governments are pretty alert now. I mean, are we getting more inquiries from international markets, and then are the impacts? It sounds like the impact trials are progressing, and if we can expect the U.S. Filing to be made soon.
Speaker Change: That's great. If you don't mind, if we can touch on the new POC strain in the DRC, I know you touched on this also.
Speaker Change: It seems like the governments are pretty alert now. I mean, are we getting more?
Unknown Executive: Inquiries from International Markets, and then there are the MPOCS trials. It sounds like the MPOCS trials are progressing, and we can expect the U.S. filing to be made soon.
Speaker Change: inquiries from international markets and then are the MPOCS you know it sounds like the MPOCS trials are progressing and if we can expect the US filing to be made soon.
Zem Wen: Yeah, maybe I can take on, and I'll start with just the more inquiries in the international market. Clearly, T-Pox, or TECA VRMAT, has the benefit of the anti-riot treatment for smallpox, which is quite important from the consideration from public health security perspective and, as such, driving stockpiles considerations from preparedness perspective. The M-Pox outbreak in 2022 heightened the awareness of orthopox threats and has driven certainly international requests. Technician, as well as the need to one-addressed inbox that breaks at a targeted level, but then a broader long-term consideration from a policy perspective from a smallpox.pyo. So while they're a little bit independent, when you think about how to look at the volumes and the preparedness requirements, they are intertwined in the consistency of increase or the pox threats, whether that's naturally occurring such as inbox, or whether it could be potentially intentionally driven from a smallpox out great perspective.
Unknown Executive: I'll start with just more inquiries in the international market, at a targeted level, but then a broader long-term consideration from a policy perspective from a smallpox stockpile. As a quick reminder, MPOCS cases were concentrated in Africa in 2022 before spreading globally. This highlights the importance of monitoring case activity in Africa when thinking globally. We have also noted that the STOMP trial has enrolled roughly 515 patients as of July. This is a substantial increase from the 350 patients noted in our last call, which is also highlighting the increased number of cases that we're observing. Assuming positive data, we'll work with our trial sponsors with the goal of filing an MPOC supplemental NDA as early as 2025. We're monitoring this situation quite closely.
Speaker Change: Yeah maybe I can take on and I'll start with just the more inquiries in the international market.
Speaker Change: Clearly, TPOX or tecovirumab has the benefit of the anti-riot treatment for smallpox.
Speaker Change: which is quite important from the consideration from a public health security perspective and as such driving stockpile considerations from a preparedness perspective
Speaker Change: The mpox outbreak in 2020 to heighten the awareness of orthopox threats and has driven certainly international recognition as well as the need to one address mpox outbreaks
Speaker Change: at a targeted level but then a broader long-term consideration from a policy perspective from a smallpox stockpile.
Speaker Change: So while they're a little bit independent when you think about how to look at the volumes and the preparedness requirements, they are intertwined in the consistency of increased orthopox.
Speaker Change: Threats, whether that's naturally occurring, such as MPOCS, or whether it could be potentially intentionally driven from a smallpox outbreak perspective.
Zem Wen: In particular, from 2022 to where we are today, we are facing another new inbox strain in the DRC, and we also share the concern of not only the rising number of inbox cases in the DRC, but also the increased prevalence of the Clave One strain, which is much more lethal than Clave Two. Empox cases have persisted over the past two years, including in the US, particularly in people who are not vaccinated, or who hasn't only received one dose of Genios. As a quick reminder, inbox cases were concentrated in Africa in 2022 before spreading globally. This highlights the importance of monitoring case activity in Africa when thinking globally.
Speaker Change: In particular, from 2022 to where we are today, we are facing another new MPOCS strain in the DRC. And we also share the concern of not only the rising number of MPOCS cases in the DRC,
Speaker Change: But also the increased prevalence of the Clade I strain, which is much more lethal than Clade II.
Speaker Change: NPOCS cases have persisted over the past two years, including in the U.S., particularly in people who are not vaccinated or who have only received one dose of JYNNEOS.
Speaker Change: As a quick reminder, MPOCS cases were concentrated in Africa in 2022 before spreading globally. This highlights the importance of monitoring case activity in Africa when thinking globally.
Zem Wen: The impact clinical trials, as mentioned, are progressing well, and we look forward to the top-line results in the POM-007 clinical trial in the DRC in the coming week. We also noted that Stomp trial has ruled roughly 515 patients as of July. This is a substantial increase from the 350 patients noted in our last call, which is also highlighting the increased cases that we're observing. Assuming the positive data will work with our trial sponsors with the goal of filing an inbox supplemental NDA as early as 2025, we're monitoring this situation quite closely, Sue. Yeah, that's great.
Speaker Change: The MPOC clinical trials, as mentioned, are progressing well, and we look forward to the top-line results in the POMM 007 clinical trial and the DRC in the coming weeks.
Speaker Change: We also have noted that the STOMP trial has enrolled roughly 515 patients as of July. This is a substantial increase from the 350 patients noted in our last call, which is also highlighting the increased cases that we're observing.
Speaker Change: Assuming the positive data, we'll work with our trial sponsors with the goal of filing an MPOC supplemental NDA as early as 2025. We're monitoring this situation quite closely, Sue.
Soo Romanoff: Okay, well thank you for the answers and great quarter again. Congratulations. Thank you. Once again, if you do want to ask a question, press star, followed by the one on your touchtone phone. Okay, there are no further questions at this time.
Speaker Change: Yeah, that's great. OK, well, thank you for the answers and great quarter again. Congratulations.
Sue: Thank you.
Speaker Change: Once again, if you do want to ask a question, press star followed by the one on your touchtone phone.
Speaker Change: For more information visit www.fema.gov
Zem Wen: I'd now like to return the call back over to Zim Win, CEO. Thanks, Steve. I'd like to thank everyone for making time to join us on today's call and for the ongoing interest in SEGA. We look forward to speaking again in our third quarter call. Have a good rest of the evening.
Speaker Change: Okay, there are no further questions at this time.
Zim Nguyen: I'd now like to return the call back over to Zim Nguyen, CEO. Zim? Thanks, Lateef. I'd like to thank everyone for making time to join us on today's call and for the ongoing interest in SIGA. We look forward to speaking to you again in our third quarter call. Have a good rest of the evening.
Unknown Shareholder: Yeah, that's great. Okay, well, thank you for the answers and another great quarter. Congratulations. Once again, if you do want
Unknown Shareholder: Great. Okay. Well, thank you for the answers and a great quarter again. Congratulations.
Zem Nguyen: Thanks, Steve. I'd like to thank everyone for making time to join us on today's call and for the ongoing interest in SIGA. We look forward to speaking to you again on our third quarter call. Have a good rest of the evening.