Q4 2024 SIGA Technologies Inc Earnings & Business Update Call
Welcome to the Seeger business update call.
Operator: Welcome to the 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. and are subject to risks and uncertainties that could cause actual assaults to differ materially from the forward-looking statement.
Are we starting to call over to Segun 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 the sorts of differ materially from the forward looking statements.
Operator: SIGA does not undertake any obligation to update publicly any forward-looking statements to reflect events or change circumstances after this call.
So you got to undertake any obligation to update.
Publicly any forward looking statements to reflect events or a change circumstances. After this call.
Operator: For a discussion of factors that could cause actual results to differ, please see the company's filings with Securities and Exchange Commission, including without limitation, the company's annual report on Form 10-K for the year ended December 31, 2024, and its subsequent reports on Form 10-Q and Form 8-K.
For a discussion of factors that could cause actual the sorts of differ please see the company's filings with.
Securities and exchange Commission, including without limitation, the company's annual report on Form 10-K for the year ended December 31st 2024.
And its subsequent reports on Form 10-Q and form 8-K.
Speaker Change: With that I will now turn the call over to Zen Nguyen Chief Executive Officer of Sika.
Operator: With that, I will now turn the call over to Zem Nguyen, Chief Executive Officer of Zem, please go ahead.
Speaker Change: Jim. Please go ahead.
Jim: Good afternoon, everyone and thank you for joining today's call and review of our business results for the fourth quarter and full year of 'twenty 'twenty four I.
Diem Nguyen: Good afternoon, everyone, and thank you for joining today's call and review of our business results for the fourth quarter and full year of 2024. I am joined by Dan Luckshire, our chief financial officer, and we appreciate this opportunity to provide an update to our company. After the update, we'll be happy to answer your questions.
Speaker Change: I am joined by Dan <unk>, our Chief Financial Officer, and we appreciate this opportunity to provide an update to our company.
Jim: After the update will be happy to answer your questions.
Diem Nguyen: I'm pleased to share that 2024 was a year of impactful execution and strong financial performance for SIGA. In 2024, we also made considerable progress on several initiatives to drive shareholder value, including one, continuing our partnership with the U.S. government, two, advancing regulatory approvals for TPOCs, and three, cultivating strategic partnerships to expand global access to TPOCs. With product sales of $133 million, up approximately 2% from 2023, we delivered the second consecutive year of product sales growth, reinforcing the critical role that TPOCs and a comprehensive smallpox preparedness program play in strengthening national security. Additionally, our results highlight the strength of our financial position.
Jim: I'm pleased to share the 'twenty 'twenty four it was a year of impactful execution and strong financial performance for Zynga and.
Jim: In 'twenty 'twenty four we also made considerable progress on several initiatives to drive shareholder value, including one continue our partnership with the U S government.
Jim: Advancing regulatory approvals for T pox, and three cultivate strategic partnerships to expand global access to Tee box.
Jim: With product sales of 133 million up approximately 2% from 'twenty to 'twenty three we delivered the second consecutive year of product sales growth.
Jim: Reinforcing the critical where all the T pox and a comprehensive smallpox preparedness program play and strengthening national security.
Jim: Additionally, our results highlight the strength of our financial position.
Diem Nguyen: Of the $133 million in product sales, about $80 million was generated in the fourth quarter from a diverse mix of revenue sources, led by deliveries of oral and IV teapots to this U.S. strategic national stockpile. This was followed by deliveries of both oral and IV teapots to the U.S. Department of Defense and deliveries of oral teapots in an international market. The latter included a notable sale in East Asia for 11 million of oral teapots, which is more than double the size of the largest prior individual teapot sale in the region. This latest international milestone follows the first sale of teapots in Africa in the third quarter in response to a request from the Ministry of Health in Morocco.
Jim: Of the hundred and 33 million and product sales about $80 million was generated in the fourth quarter from a diverse mix of revenue sources led by deliveries of oral and IV keep pox two the U S strategic national stockpile.
Jim: This was followed by deliveries of both oral and IV T. Pox, two the U S Department of defense and deliveries of royalty pocket and in international markets.
Jim: The latter included a notable sell in East Asia for 11 million of oral per Pax, which is more than double the size of the largest fire individual T. Pax dealt with in the region.
Jim: This latest international milestone follows the first sale of T. Pax in Africa in the third quarter in response to a request from the Ministry of health in Morocco.
Jim: Beyond the 'twenty 'twenty four top line financial results, we have taken important steps to advance our key initiatives and strengthen our company, which we believe will produce shareholder value overtime.
Diem Nguyen: Beyond the 2024 top-line financial results, we have taken important steps to advance our key initiatives and strengthen our company, which we believe will produce shareholder value over time. I would like to highlight some of these steps. We continue to make progress on our international markets. Two examples stand out. First, midway through 2024, our company assumed responsibility for promoting teapots outside the U.S. from Meridian Medical Technologies. This action has brought us much closer to our current and potential future customers, thereby enabling us to better understand and meet their needs. We started to build an international sales and marketing infrastructure in 2024 and plan to continue to invest in that infrastructure to achieve our full potential in the international market.
Jim: I would like to highlight some of these steps.
Jim: We continue to make progress on our international markets two examples stand out.
First midway through 2024, our company assumed responsibility for promoting T. Pax outside the U S from Meridian medical technologies.
Jim: This action was brought us much closer to our current and potential future customers, thereby enabling us to better understand and meet their needs.
Jim: We started to build in international sales and marketing infrastructure in 'twenty 'twenty, four and plan to continue to invest in that infrastructure to achieve our full potential in our international markets.
Diem Nguyen: We believe our conversations and actions will yield positive results over time.
Jim: We believe our conversations and actions will yield positive results overtime.
Jim: Second as announced earlier this year, we achieved another international regulatory approval, when Japan's pharmaceuticals, and medical devices agency.
Diem Nguyen: Second, as announced earlier this year, we achieved another international regulatory approval when Japan's Pharmaceuticals and Medical Devices Agency, in collaboration with the Japan Ministry of Health, Labor and Welfare, approved TPOX for the treatment of a broad range of orthopoxviruses. This approval marked another important milestone in our efforts to expand access to TPOC. Additionally, it, coupled with the growing sales of teapots in East Asia, reinforces the value of antiviral stockpiling to ensure supply resilience during immediate crisis response to safeguard communities and individuals against smallpox. To obtain this approval, and in collaboration with our local partner, Japan Biotechnology Pharma, we submitted a robust data package, which included studies involving healthy human volunteers, non-human primates, and rabbits.
In collaboration with the Japan Ministry of Health Labor and welfare approved <unk> for the treatment of a broad range of worth of pox viruses.
Jim: This approval marked another important milestone in our efforts to expand access to cheap pox.
Jim: Additionally, it's coupled with a growing sales of Teapots in East Asia reinforces the value of the anti virus stockpiling to ensure supply resilience during immediate crisis response.
Jim: Safeguard communities and individuals against smallpox.
Jim: To obtain this for approval and in collaboration with our local partner, Japan biotech pharma, we submitted a robust data package, which included studies involving healthy human volunteers nonhuman primates and rabbits.
Diem Nguyen: No other drug approved to treat smallpox or any other orthopoxvirus is supported by such a comprehensive and extensive data package.
Jim: No other drug approved to treat smallpox or any other orthopoxvirus supported by such a comprehensive and extensive data package.
Jim: Shifting gears on cultivating strategic partnerships in October we announced an exclusive license to a portfolio of preclinical fully human monoclonal antibodies from the Vanderbilt University that have the potential to treat a broad range of orthopoxvirus is including smallpox and impact that.
Diem Nguyen: Shifting gears on cultivating strategic partnerships, in October, we announced an exclusive license to a portfolio of preclinical, fully human monoclonal antibodies from the Vanderbilt University that have the potential to create a broad range of orthopoxviruses, including smallpox and mpox. Leveraging our existing capabilities to create new opportunities over the long term, we believe this portfolio has the potential to complement our TPOC franchise and provide patients with additional therapies in this space. While monoclonal antibodies represent an early stage component of our pipeline, RT-Pox post-exposure prophylaxis program for smallpox or PEP is far more advanced. We continue to collaborate with the CDC in consultation with the FDA to complete the analysis of the samples collected to support the study's immunogenicity objective.
Jim: Leveraging our existing capabilities to create new opportunities over the long term. We believe this portfolio has the potential to complement our T pucks franchise and provide patients with additional therapies in this space.
Jim: Well monoclonal antibodies represent an early stage component of our pipeline Archie Pucks post exposure prophylaxis program for smallpox or pet is far more advanced.
Jim: We continue to collaborate with the C. D C in close consultation with the FDA to complete the analysis of the samples collected to support the studies Immunogenicity objective.
Jim: As a reminder, the safety object, where they're already been successfully achieved.
Diem Nguyen: As a reminder, the safety objective has already been successfully achieved. The CDC's work is underway and we believe they will complete their analysis around the middle of this year.
Jim: The C. D. C is work is underway and we believe they will complete their analysis around the middle of this year.
Diem Nguyen: Based upon their projected timeline, we are now targeting an FDA submission for the PEP indication in early 2026.
Jim: Based upon their projected timeline, we are now targeting at an S. P. A submission for the Pep indication in early 2026.
Diem Nguyen: In addition to our successes, we've also faced some challenges this year, given the PALM-007 and STOMP clinical trial results in MPOC. While the results of these trials were not a surprise given the mechanization of TPOX and the design of the trials, they have led to some important discussions about TPOX that I'd like to address today. By the way of background, T-POX was developed as a treatment for smallpox with the primary goal of reducing mortality and saving lives in an event of an outbreak. Approval under the FDA's rigorous animal rule, T-pox is supported by extensive studies demonstrating its safety and efficacy in reducing mortality from smallpox.
Jim: In addition to our successes we've also faced some challenges this year given the palm. There is there are seven and stopped clinical trial resulted in pox.
Jim: While the results of these trials were not a surprise given the mechanism of action of T pox and the design of the trials. They have led to some important discussions about T. Pax that I liked it addressed today.
Jim: By the way of background keep hoxworth develop as a treatment for smallpox with a primary goal of reducing mortality and saving lives in the event of an outbreak.
Jim: Approval under the F D. A rigorous animal rule. He pakse supported by extensive studies, demonstrating its safety and efficacy in reducing mortality from smallpox.
Jim: This small pox vaccination programs were discontinued several decades ago herd immunity has diminished leaving populations vulnerable to its potential reintroduction.
Diem Nguyen: Since smallpox vaccination programs were discontinued several decades ago, herd immunity has diminished, leaving populations vulnerable to its potential reintroduction. For example, in the U.S., approximately 190 million people were born after the end of the routine vaccination, leaving these Americans vulnerable. Additionally, the robustness of the immune response in those vaccinated more than 50 years ago cannot be determined. As such, the potential for an intentional reintroduction remains a serious concern. For POM007 and STOMS, SIGA donated the product to trial sponsors to help advance mpox research and support response to the 2022 global mpox outbreak. Because MPOX is a far milder and largely self-resolving disease with a much lower mortality rate than smallpox, these trials were designed to measure the time for all lesions to heal between patients receiving TPOX and those receiving placebo.
Jim: For example in the U S. Approximately 190 million people were born after the end of the routine vaccination, leaving these Americans vulnerable.
Jim: Additionally, the robustness of the immune response in those vaccinated more than 50 years ago cannot be determined.
Jim: As such the potential for its intentional reintroduction remains a serious concern.
Jim: For Palm there there are seven in stop he got donated the product to trial sponsors to help advance impasse research and supportive sponsor to the 2022 global and pox outbreak.
Jim: Because impasse is a far milder and largely self resolving disease with a much lower mortality rate than smallpox. These trials were designed to measure the time for all lesions to heal between patients receiving T pox and those receiving placebo.
Jim: While these studies did not show statistical significance difference between ticket and placebo at this primary endpoint. The path. There is there are seven results did signal potential benefits for patients treated early or with severe disease.
Diem Nguyen: While these studies did not show statistical significance difference between ticaviramide and placebo at this primary endpoint, the POM007 results did signal potential benefits for patients treated early or with severe disease. Generally speaking, viruses replicate faster in the initial stages of infection, and administrating antivirals early helps curb virus replication before reaching its peak load, thereby reducing the severity of the disease. This principle was exemplified during the COVID-19 pandemic, where timely administration of antivirals proved critical in proving patient outcomes. The same principle applies to TPOC. Ticovirumat works to reduce viral release from infected cells. Based upon Ticovirumat's mechanism of action, we believe treatment would be optimized when administered early in symptoms, or ideally post-exposure prophylactics.
Jim: Generally speaking viruses replicate faster in the initial stages of infection and ministration anti Virals early helps curb virus replication before reaching its peak load there.
Jim: And thereby reducing the severity of the disease. This principle was exemplified during the COVID-19 pandemic were timely administration of anti virus proved critical in improving patient outcomes.
Jim: The same principle applies to T pox.
Jim: Take a fair amount of work to reduce viral released from infected cells based upon check of air Max mechanism of action, we believe treatment would be optimized when administered early in citizens or ideally post exposure prophylaxis.
Diem Nguyen: The early phase of disease includes viral amplification and dissemination throughout the body. As the disease progresses, the immune system works to clear the virus already released from the cell after replication. In POM007, we saw the potential benefits for patients treated early or with severe disease. We're currently assessing viral load impact in NPOX patients over time, as we expect reduction in virus load with tick-avariant administration early, consistent with our non-human primate models. Both POM007 and STOMP enrolled patients at later stages of disease, a medium about 5.9 and 8 days, respectively, after self-reported symptom onset.
Jim: The early phase of disease includes viral amplification and dissemination throughout the body.
Jim: As a disease progresses, the immune system works to clear the virus already released from the cells after replication.
Jim: And palms, there theyre seven we saw the potential benefits for patients treated earlier with severe disease.
Jim: We're currently assessing viral load impact in M. <unk> patients over time as we expect a reduction in viral load with tickets are met administration early consistent with our nonhuman primate models.
Jim: Well, it's part of their seven and stopped enrolled patients at later stages of disease, a medium about 5.9 and eight days respectively. After self reported symptom onset.
Diem Nguyen: We believe these trials are not necessarily reflective of how or when the drug should be used based on its mechanism of action and potential value in smallpox outbreak. We believe TPOX remains a vital countermeasure for reducing mortality from smallpox. In a comprehensive preparedness plan, antivirals provide a critical line of defense. Complementing vaccines, antivirals can be used to treat an infection in patients who have not been vaccinated or do not benefit from vaccination. Certain antivirals have the potential to prevent onset of viral illness after exposure to the virus. The relationship between vaccines and antivirals is particularly important as we face the growing challenge of emerging infectious diseases and the threats of bioterrorism.
Jim: We believe these trials are not necessary were effective of how or when the drug should be used based on its mechanism of action and potential value in smallpox outbreak.
Jim: We believe chipotle remains a vital countermeasure for reducing mortality from smallpox.
Jim: And our comprehensive preparedness plan anti virus provide a critical line of defense.
Jim: Complementing vaccines anti virus can be used to treat infection in patients who had not been vaccinator or do not benefit from vaccination.
Jim: Certain anti virals have the potential to prevent onset of viral illness. After exposure to the virus the relationship between vaccines and anti Virals is particularly important as we face the growing challenge of emerging infectious diseases and the threat of bioterrorism.
Diem Nguyen: Strategic stockpiling of antivirals helps ensure a swift, coordinated response when disaster strikes.
Jim: Strategic stockpiling of anti Virals. It helps ensure a swift coordinated response when disaster strikes.
Jim: Looking forward, we believe securing a new contract for the continuous supply of cheap talks to the strategic national stockpile or S. N S represent an opportunity to enhance our company's long term potential and help advance our national securities or bioterrorism preparedness.
Diem Nguyen: Looking forward, we believe securing a new contract for the continuing supply of TPOCs to the Strategic National Stockpile, or SNS, represents an opportunity to enhance our company's long-term potential and help advance our national security through bi-terrorism preparedness. Since the new U.S. administration took office, we have seen many bold initiatives launch and executive orders enacted, with more changes expected as new leaders are nominated, confirmed, and put in place. With any change of administration, this takes time. While change can create uncertainty, it can also create long-term opportunities as priorities are clarified and new policies are enacted to enhance national security.
Jim: And so you New U S administration took office, we've seen many bold initiatives launch and executive orders enacted with more change is expected as new leaders are nominated confirmed and put in place.
Jim: With any change of administration this takes time.
Jim: Change can create uncertainty can also create long term opportunities as priorities are clarified and new policies are enacted to enhance national security.
Diem Nguyen: We will continue to monitor these developments and assess the potential impact, if any, on our company. Whatever transpires, we believe we are well-positioned to engage with the new ASPR as well as other senior officials on the nature and timing of an RFP for a new contract for TPOC. As a reminder, ASPR is within the US HHS and houses the Center of the Biomedical Advanced Research and Development Authority, or BARDA, and the S&S. For reference, SIGA has been providing TPOCs to the ASPR for more than a decade, and national security is an issue that transcends political considerations.
Jim: We will continue to moderate or do these developments and assess the potential impact if any on our company.
Jim: Whatever transpires, we believe we are well positioned to engage with the new asper as well as other senior officials on the nature and timing of an RFP for a new contract for T pox.
Jim: As a reminder, as far as within the U S. H H test and houses the center of the Biomedical advanced research and development authority or BARDA and the S. N S.
Jim: For reference so you guys have been providing to pox two the asps are for more than a decade and national security is an issue that transcends political considerations.
Diem Nguyen: We believe the new administration is committed to maintaining a robust preparedness strategy, which includes a supply of antibiotherapies to treat smallpox. Furthermore, our current 19C contract was awarded under President Trump's leadership in 2018.
Jim: We believe the new administration is committed to maintaining a robust preparedness strategy, which includes the supply of anti viral therapies to treat smallpox.
Jim: Furthermore, our COVID-19 see contract was awarded under President Trump's leadership in 2018.
Diem Nguyen: With this in mind, we stand ready to negotiate with the new ASPR with the objective of completing a new contract in 2025.
Jim: With this in mind, we stand ready to negotiate with the new asper with objective of completing a new contract in 2025.
Jim: In summary, this is a dynamic time for Sega where strong resilient and profitable.
Diem Nguyen: In summary, this is a dynamic time for SIGA. We are strong, resilient, and profitable. Our strategy is yielding results. Our disciplined approach to capital management gives us optionality. Our TPOX franchise meets a critical need for smallpox preparedness. And our team has the expertise to drive results over the long term in the best interest of our customers and shareholders.
Jim: Our strategy is the other.
Jim: Results.
Jim: Our disciplined approach to capital management gives us optionality.
Jim: T Pax franchise meets a critical need for smallpox preparedness and our team has the expertise to drive results over the long term in the best interests of our customers and shareholders.
Diem Nguyen: In short, with a strong foundation, we believe we are well positioned for the future and opportunities ahead.
Jim: In short with a strong foundation, we believe we are well positioned for the future and the opportunities ahead.
Daniel Luckshire: With that, I'll turn it over to Dan to review the financial results in more detail.
Jim: With that I'll turn it over to Dan to review the financial results in more detail.
Dan: Thanks Sam.
Daniel Luckshire: Thanks, Zim. As noted earlier in the call, SIGA's product sales for this year surpassed a year's sales. This represents the second straight year of sales growth and a new high watermark for annual sales since FDA approval of TPOPS in 2018. Product revenue for full year 2024 was $133 million. Of this amount, $80 million was recognized in the three months ended December 31st, 2024. In the fourth quarter, $51 million of oral teapots and $9 million of IV teapots was delivered to the Strategic National Stockpile, or SNS. $9,000,000 in mostly oral teapots. and a small amount of IV teapots was delivered to the U.S.
Dan: As noted earlier in the call because product sales for this year surpassed for yourselves.
Dan: This represents the second straight year of sales growth and a new high watermark for annual sales since FDA approval of coupons in 2018.
Dan: Product revenue for full year 2024 was $133 million.
Dan: All of this amount 80 million was recognized in the three months ended December 31 2024.
Dan: In the fourth quarter $51 million of royalty parks and $9 million of IV Tee box was delivered to the strategic national stockpile or S. N S.
Dan: Dollars and most of the World key parks.
Dan: The small amount of IV T parks.
Over to the U S Department of defense.
Daniel Luckshire: Department of Defense.
Daniel Luckshire: And there was an $11 billion sale to an international customer in the East Asia region. To reiterate the comment made earlier in the call, the international sale in the fourth quarter represents a milestone in that it is more than double the size of the largest prior individual teapot sale in the East Asia region. With respect to product sales for the full year 2024, the $133 million amount comes from a diverse mix. Similar to the diversity in the fourth quarter. The revenue mix includes $74 million of oral TPOC sales to the S&S, $26 million of IV TPOC sales to the S&S, $10 million of oral and IV TPOC sales to the U.S.
Dan: And there was an $11 billion sale to an international customer and the East Asia region.
Dan: To reiterate a comment made earlier in the call the international sale in the fourth quarter represents a milestone in that it is more than double the size of the largest private individuals T Park sale and the East Asia region.
Dan: With respect to product sales for the full year 2020 for C 133 million dollar amount comes from a diverse mix.
Dan: Similar to the diversity in the fourth quarter.
Dan: The revenue mix includes 17.
Dan: $74 million royalty box sales to be asking us for.
Dan: $6 million at high P. IV Tupac sales to be asking us 10.
Dan: $10 million of oral and IV T Pax sales to the U S Department of defense.
Daniel Luckshire: Department of Defense, and 23 million of world teapot sales to 13 international customers. In addition to product-related revenues, the company also had research and development revenues. For the 3 and 12 months ended December 31, 2024, research and development revenues were $1.6 million and $5.4 million, respectively. Pre-tax operating income, which excludes interest income and taxes, was approximately $57 million for the three months ended December 31, 2024. For the full year 2024, pre-tax operating income was approximately $70 million. In comparison, there's a pre-tax operating income for the 3 and 12 months ended December 31, 2023 of approximately $92 million and $84 million, respectively.
Dan: And $23 million of royalty Pax sales to 13 international customers.
Dan: In addition to product related revenues. The company also had research and development revenues for.
Dan: For the three and 12 months ended December 31, 2020 for research and development revenues were $1.6 million and $5 four.
Dan: $4 million respectively.
Dan: Pre tax operating income, which excludes interest income and taxes was approximately $57 million for the three months ended December 31 2024 for.
Dan: For the full year 2024 pretax operating income was approximately $70 million.
Dan: In comparison, there was a pre tax operating income for the three and 12 months ended December 31, 2023 of approximately $92 million and $84 million respectively.
Dan: I would like to know the differences between pretax operating income margin in 'twenty 'twenty, four and 'twenty to 'twenty three reflects different product mixes in those periods.
Daniel Luckshire: I would like to note that differences between pre-tax upward income margin in 2024 and 2023 reflects different product mixes in those periods. That income for the three months ended December 31st, 2024 was approximately $46 million. For the 12 months ended December 31st, 2024, that income was approximately $59 million. In turn, fully diluted income per share for the three months ended December 31st, 2024 was 63 cents. And for the full year 2024, fully diluted income per share was 82 cents. Throughout 2024, the company continued to maintain a strong balance sheet through an abiding commitment to financial discipline.
Dan: Net income for the three months ended December 31, 2024 was approximately $46 million.
Dan: For the 12 months ended December 31, 2024, net income was approximately $59 million.
Dan: In turn fully diluted income per share for the three months ended December 31 2024.
Dan: 63 cents.
Dan: For the full year 2024.
Dan: Diluted income per share was 82 six.
Dan: Throughout 2024, the company continued to maintain a strong balance sheet.
Dan: Through an abiding commitment to financial discipline.
Daniel Luckshire: At December 31st, 2024, the company had a cash balance of $155 million and no debt. Looking forward to 2025, I would like to note that we had a $70 million outstanding order bounce at December 31st, 2024, which we expect to deliver in 2025.
Dan: At December 31st 2024, the company had a cash balance of $155 million.
Dan: And no debt.
Dan: Looking forward to 2025.
Dan: I'd like to note that we had a $70 million $70 million outstanding order balance at December 31, 2024, which we expect to deliver in 2025.
Dan: This concludes the financial update at this point I will turn the call back to Sam.
Daniel Luckshire: This concludes the financial update.
Diem Nguyen: At this point, I will turn the call back to Zim. Thank you, Dan.
Sam: Thank you Dan with that we would like to open the call for questions.
Operator: With that, we would like to open the call for questions. Thank you. Ladies and gentlemen, we will now begin the question and answer session. If you have a question, please press star followed by the number 1 on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number 2. If you are using a speakerphone, please lift the handset before pressing any key. One moment, please, for your first question.
Speaker Change: Thank you ladies and gentlemen, we will now begin the question and answer session.
Speaker Change: Have a question. Please press star followed by the number one on your Touchtone phone.
You will hear a prop that your hand, it's been raised.
Speaker Change: Should you wish to decline from the polling process. Please press star followed by the number too.
Speaker Change: If you are using a speaker phone please lift the handset before pressing any keys one moment. Please for your first question.
Speaker Change: Okay.
Jyoti Prakash: Your first question comes from the line of Jyoti Prakash from Edison Group. Your line is now open. Hi, thank you for taking my questions. My first question relates to oral TPOX deliveries. We understand that around $60 million has been delivered from the most recently exercised BADA option. Have there been any additional deliveries in 2025 to date? And can we expect the entire remaining order to be delivered in the first half, given the expected RFP timelines with the U.S. authorities?
Speaker Change: Your first question comes from the line of Joe D. Prakash from Edison Group. Your line is now open.
Speaker Change: Okay.
Speaker Change: Oh, hi, Thank you for taking my questions.
Speaker Change: My first question relates to OLED Bulks deliveries.
Speaker Change: We understand that around $60 million has been delivered from the most recently exercised by the option.
Speaker Change: Have there been any additional deliveries in 2020 five to date.
Speaker Change: And can we expect the entire remaining audited we'd delivered in default tough.
Speaker Change: Given the expected Odyssey timelines with the U S authorities.
Speaker Change: Thanks, Jody I'll, let Dan answer that question.
Daniel Luckshire: Thanks Jyoti, I'll let Dan answer that. Thanks for the question, Jyoti. As noted in our prepared remarks, we had 70 million in outstanding orders at December 31st, 2024. These orders mostly consist of remaining deliveries of oral and IV teapots to the S&S under existing order. We currently expect those deliveries to start in the second quarter based on coordination with the United States government. And we expect all 70 million of the outstanding orders to be delivered in 2025.
Speaker Change: Yeah. Thanks for the question Judy.
Speaker Change: As noted in our prepared remarks, we had $70 million outstanding orders at December 31, 2024.
Most of these orders are these orders mostly consist of remaining deliveries of oral and IV <unk> to the SNS under existing orders.
Speaker Change: We currently expect those deliveries to start in the second quarter based on coordination with the United States government.
Speaker Change: And we expect all 70 million of the outstanding orders to be delivered in 2025.
Speaker Change: There's one.
Unknown Speaker: Unknown Speaker At the very end, you mentioned the RFP and Make sure for clarity purposes, just to highlight that the RFP process is a separate process from the delivery process under the 19C contract. The RFP timing is not impacted by the delivery. Thanks a lot. That's really helpful.
Speaker Change: At the very end you you mentioned the RFP.
Speaker Change: Yes, just to yeah.
Speaker Change: Make sure for clarity purposes, just to highlight that.
Speaker Change: The RFP process.
Speaker Change: Separate process from the delivery process under the 19 see contract.
Speaker Change: And in fact, you know the RFP timing is not impacted by the delivery timing just wanted to make to make that clear.
Speaker Change: It sounds like that that's really helpful. My second question relates to your cash position so.
Daniel Luckshire: My second question relates to your cash position. So you ended the year with a strong cash balance of $155 million. Can we expect you to announce another special dividend this year as you've been doing every year since 2022? So I'll also take that question too. Before I get into the direct answer, let me just give you some background. So, as a starting point, our capital management strategy is Outcome Analysis, Professional Excellence, This approach has been used over the past series of years. And so with that. Timing of a Special Cash Dividend each year is influenced by several factors, which we regularly review.
Speaker Change: You ended the era with a strong cash balance of 1 million and $55 million.
Speaker Change: Can we expect you to announce another special dividend this year as you've been doing every year since 2022.
Speaker Change: So I'll also take that question too.
Speaker Change: Before I get into the direct answer let me just give you some background.
Speaker Change: So as a starting point of our capital management strategy is not to be dynamic and tailored to optimize positive outcomes for our shareholders.
Speaker Change: In the short term balancing the short term and the long term.
Speaker Change: This approach has been used over the past series of years.
Speaker Change: And so with that the timing of a special cash dividend each year, it's influenced by several factors, which we regularly review.
Daniel Luckshire: Some of the factors include cash flow performance. Capital Allocation Priorities So there's a series of factors that we're continually reviewing. And so when you look at prior years, there's really no specific timeline for when special cash dividends occur. in 22 and 23. The Board of Directors declared special cash dividends in May, which were paid in June. and then in 24. Special Cash Dividend was declared in March. paid in April. So there's some movement in terms of So when you sort of bring all these things together to your question. When you take all these things into account, we currently anticipate making a capital management decision.
Speaker Change: Some of the factors include cash flow performance.
Speaker Change: Capital allocation priorities external market conditions.
Speaker Change: So theres a series of factors like we were continually reviewing them and so when you look at prior years, there's really no specific timeline for when its special cash dividends occur.
Speaker Change: In 'twenty, two and 'twenty three.
Speaker Change: The board of directors declared a special cash dividends in May which were paid in June.
Speaker Change: And then in 'twenty four.
Speaker Change: The special cash dividend was declared in March.
Speaker Change: Is it was paid in April so there is some movement in terms of timing.
Speaker Change: So when you sort of bring all these things together.
Speaker Change: To your question I.
Speaker Change: When you take all these things into account.
Speaker Change: We currently anticipate a make.
Speaker Change: Making a capital management decision.
Speaker Change: In the second quarter, which is sort of which is consistent with the timing for most prior years.
Unknown Speaker: in the second quarter, which is consistent with the timing for most prior. Great.
Speaker Change: Great.
Jyoti Prakash: My next question relates to your international group.
Speaker Change: My next question relates to your international growth.
Speaker Change: First of all congratulations on receiving regulatory approval in Japan for people.
Jyoti Prakash: First of all, congratulations on receiving the regulatory approval in Japan for TPOC. Can you provide some more details in terms of your distribution agreement with Japan Biotechnology Pharma? And just to follow up on that.
Speaker Change: Can you provide some more details in terms of your distribution agreement with Japan biotech know pharma.
Speaker Change: And just to follow up on that.
Speaker Change: Oh yeah.
Diem Nguyen: You made $11 million of international sales in the last quarter. Does that relate to delivery to Japan's strategic national stockpile? on the first part of the question. The terms of the distribution agreement with Japan Biotechno Pharma or JBP. terms have not been disclosed. What we can say, though, is that Distribution Agreements with JVP or within other countries. different in nature than the promotion agreement we had with Meridian. The key point here is that distribution agreement. will not have the same level of fees that were paid. a much more efficient model. financially better.
Speaker Change: You made an $11 million of international it seems in the last quarter does that they need to deliver to do do Japan strategic national stockpile.
Speaker Change: Right so.
Speaker Change: On the first part of the question.
Speaker Change: The terms of the distribution agreement with Japan by techno pharma or J B P.
Speaker Change: These terms have not been disclosed.
Speaker Change: But what we can say, though is that.
Speaker Change: The distribution agreements with GBP or within other countries.
Speaker Change: Different in nature than the promotion agreement, we had with Meridian and the key point here is the distribution agreement.
Speaker Change: We will not have the same level of fees that were paid to radian.
Speaker Change: It's a much more efficient model.
Speaker Change: And.
Speaker Change: Truly better for us.
Speaker Change: On the second part of that question in terms of the 11 million to other international sale.
Diem Nguyen: on the second part of that question in terms of the $11 million international sale. Right now, at this time, we're not currently disclosing that customer.
Speaker Change: Right now at this time, we're not currently disclosing dotcom customer as mentioned in the prepared remarks customers located in East Asia area, but we're not disclosing the specific customer.
Speaker Change: Oh, thank you for that.
Jyoti Prakash: Thank you for that.
Jyoti Prakash: I have another couple of questions. So the next one is related to the NPOX opportunity. How do you see that evolving given the results from the PAM-007 and STORM trials? We understand that they were subsets of patients who saw good results in the plan to adjust the design of the remaining trials to focus on these particular subset of patients.
Speaker Change: I have been out there a couple of questions. So then the next one is related to the end bulks opportunity.
Speaker Change: How do you see that evolving given the results from the bonds have been installed Giants.
Speaker Change: Time, that'd be one subsets.
Speaker Change: Which is a subset of patients, which who saw good results in the bomb.
Speaker Change: Seven child so.
Speaker Change: Is there any plan to adjust the design of the Dominion trials to focus on these particular subset of patients.
Diem Nguyen: Jyoti, thanks for that question. I'll take this one. Just a overarching concept. We are continuing to work with NIAID. They are specifically the POM007 and STOMP trial sponsors. We are working with them to fully analyze the clinical data, including reviewing data from certain subgroups, as you mentioned, to determine what types of patients may potentially benefit the most from Ticavirumab as well as the optimal treatment regimen. Once this data analysis is complete, we will then be in a better position to determine the best path forward from both a clinical trial and regulatory perspective. I think it is important to note that while we learned a lot from these trials, they certainly had some limitations associated with the trial design.
Speaker Change: Tony Thanks for that question I'll take this one just a overarching concept we are continuing to work with NIAID.
Speaker Change: And they are specifically the palms, there there are seven and stomp trial sponsors.
Speaker Change: We are working with them to fully analyze the clinical data, including reviewing data from certain subgroups as you mentioned to determine what types of patients they potentially benefit the most from ticket fair amount as well as the optimal treatment regimen.
Speaker Change: Once this data analysis is complete we will then be in better position to determine the best path forward from both a clinical trial and regulatory perspective.
Speaker Change: It is important to note that while we learned a lot from these trials. They certainly had some limitations associated with the trial design. The primary objective was to provide access from a humanitarian perspective.
Diem Nguyen: The primary objective was to provide access from a humanitarian perspective. That was particularly consistent in the PALM-007. These trials were not designed by SIGA and they were not designed with a drug development in mind. As the result, we express some of the limitations associated with the mechanization. Antivirals generally work. based on how their mechanization is executed. To compare my specific mechanization, The typical patient profile, the design of the trials, it's not unexpected these trials did not meet their primary endpoint to full resolution of all lesions. As with the case of STOMP and POM007, SIGA is not the sponsor of these ongoing trials, so we do not have the ability to modify the designs based on learnings with current ongoing trials.
Speaker Change: That was particularly consistent in the palm there there are seven of them.
Speaker Change: These trials are not designed by Sega and they were not designed with a drug development in mind.
Speaker Change: As a result, we express some of the limitations associated with the mechanism of action.
Speaker Change: Anti Virals generally work.
Speaker Change: Based on how their mechanism of action is executed to go very much specific mechanism of action.
Speaker Change: The typical patient profile the design of the trials, it's not unexpected. These trials did not meet their primary endpoint to full resolution of all lesions.
Speaker Change: As with the case of stop and palms. There. There are seven figure is not the sponsor of these ongoing trials. So we did not have the ability to modify the designs based on learnings with current ongoing trials.
Diem Nguyen: However, saying that, Jyoti, we will continue to evaluate the potential benefit of ticuverumat treatment in AMPOX patients and then design and execute on further studies according.
Speaker Change: However, saying that Jody we will continue to evaluate the potential benefit of ticket very met treatment of empower patients and their.
Speaker Change: Then design and execute on further studies accordingly.
Speaker Change: Great.
Jyoti Prakash: Great, that's super helpful.
Speaker Change: That's super helpful and I have one final question well do you think of the recent funding for the NIH by the Trump administration and do you see any sort of flow through impact.
Jyoti Prakash: And I have one final question. What do you think of the recent funding cuts for the NIH by the Trump administration? And do you see any sort of flow through impact on your expected RFP for TPOR?
Speaker Change: On your expected honest Stifel D box.
Diem Nguyen: Jyoti, we can only speak on the behalf of SIGA. First and foremost, I would say that SIGA has a long history of collaboration with the U.S. government agencies. including through four administrations that is inclusive of Biden, Trump, Obama, and Bush, and these relationships naturally evolve following changes in leadership from an administration. For now, our focus remains on maintaining strong partnerships and continue to play an important role in supporting the U.S. National Security and Public Health Initiative. Based on our experiences and conversations today, we do believe national security is of utmost importance, and it does transcend partisan politics, and that the new administration is committed to maintaining a robust preparedness strategy, which does include supply of antiviral therapies to treat smallpox.
Speaker Change: Thanks, Jody we can only speak on the behalf of Seeger.
Speaker Change: First and foremost I would say that CECO has a long history of collaboration with a U S government agencies, including through for administration that is inclusive of Buyten Trump Obama and Bush and these relationships naturally evolve falling changes in leadership from an administration perspective.
Speaker Change: For now our focus remains on maintaining strong partnerships and continue to play an important role in supporting the U S National security and public health initiatives.
Speaker Change: Based on our experiences in conversation today, we do believe national security is of utmost importance and it does transcend part partisan politics.
Speaker Change: And that the new administration is committed to maintaining a robust preparedness strategy, which does include supply of anti viral therapies to treat smallpox.
Diem Nguyen: Whatever transpires during this transition period, we believe we are well positioned to engage with the new ASPR as well as other senior officials on the nature and timing of an RP for a new contract for TPOCs.
Speaker Change: Transpires during this transition period, we believe we are well positioned to engage with the new asper as well as other senior officials on the nature and timing of the RFP for a new contract for T pox.
Diem Nguyen: At this time, any further comment would be purely speculative in nature.
Speaker Change: At this time any further comment would be purely speculative in nature.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Oh. Thank you so much no further questions and congratulations again on this one quarter.
Jyoti Prakash: Thank you so much.
Operator: No further questions and congratulations again on the Strong Quarter. As a reminder, if you have a question, please press star 1 on your telephone keypad.
Speaker Change: Thanks Jody.
Speaker Change: Yeah.
Speaker Change: As a reminder, if you have a question. Please press star one on your telephone keypad.
Speaker Change: Your next.
Brian Adams: Your next question comes from the line of Brian Adams from Parker Cargo Terry, your line is now open. Thank you very much and great year. A couple quick questions on the kind of process of reengaging with BARDA and potentially again, blue skies, you know, gray skies looking forward. If this were a baseball game and it's nine innings, and we're re-upping the contract for We all hope to be maybe a number that would be greater than the 550, 575 million in the original contract six years ago. Where do you think we stand on this? Are we, you know, the fourth inning, fifth inning, you had kind of alluded to, ma'am.
Speaker Change: <unk> come from the line of Brian Adams from Parker cargo Terry Your line is now open.
Speaker Change: Thank you very much and a great year.
Speaker Change: Yeah.
Speaker Change: A couple of quick questions.
Speaker Change: On the kind of a process.
Speaker Change: The process of re engaging with BARDA and potentially again blue Sky Gray Sky is looking forward.
Speaker Change: If this were a baseball game and it's nine innings and we're re upping the contract for.
Speaker Change: We all hope to be maybe a number that would be greater than that of 550 575 million of the original contracts six years ago.
Speaker Change: Where do you think we stand on this are we.
Speaker Change: The fourth inning fifth inning are you kind of alluded to many of them.
Diem Nguyen: Dr. Nguyen that some kind of decision would be made this year, would there be a COLA increase, maybe a number in the $700 to $800 million range? That's my first question. And then secondly, the inventory that's on the book shows $49 million. What exactly is that, that's the value of the drug on your, that can be deployed, and I'm assuming that will meet a portion of the $70 million of the legacy contract that still, you know, needs to be filled.
Speaker Change: A doctor when there were some kind of decision would be made this year.
Speaker Change: Would there be a cola increase maybe a number of the 700 or $800 million range. That's my first question.
Speaker Change: And then secondly, the inventory that's on the books showed $49 million.
Speaker Change: What exactly is that the value of the drug on your that can be deployed.
Speaker Change: <unk> deployed.
Speaker Change: And I'm, assuming that will meet a portion of the $70 million of the legacy contract that still needs.
Speaker Change: Needs to be filled.
Diem Nguyen: So those are my first 2 questions.
Speaker Change: Those are my first two questions.
Speaker Change: Hi, Brian Thanks for the thoughtful questions I will target. The first section and then let Dan talk to you through with the inventory that first and foremost I would start by saying that we have continued conversations with BARDA and Act and act in terms of take up there, Matt and it's primary treatment of <unk>.
Diem Nguyen: Hi Brian, thanks for the thoughtful questions. I will target the first section and then let Dan talk to you through with the inventory. First and foremost, I would start by saying that we have continued conversations with BARDA and SNS. of Kick'em Very Mad and its primary treatment of choice for moms. There is a continued reinforcement of this important. The U.S. government from a preparedness We have talked quite a bit about manufacturing strategies as well as However, Brian, we have not identified. range of volume to date. I can only say, based on the macrodynamics that we're facing in our environment today, that the smallpox threat continues to increase.
Joyce: Joyce for smallpox.
Joyce: There is a continued reinforcement of this important too.
Joyce: The U S government from other Paradise perspective.
Joyce: We have talked quite a bit about manufacturing strategies as well as.
Joyce: Potential volume.
Joyce: However, Brian we have not identified at specific range of volume to date I can only say based on the macro dynamics that were facing in our environment today.
Joyce: The small pox threat continues to increase now whether that be from geopolitical tensions or from naturally occurring concerns based on a vulnerable patient population that may not be vaccinated.
Diem Nguyen: Now whether that be from geopolitical tensions or from naturally occurring concerns based on a vulnerable patient population that may not be vaccinated, we think that this is certainly an important time to reflect on the volume requirement.
Joyce: This is certainly an important time to reflect on the volume requirement.
Daniel Luckshire: And that discussion still remains to be executed or discussed. Yeah, so on the question about inventory, and it ties a little bit. You know, given what's happening on the getting ratchet. And with that, we've been trying to be proactive. having products throughout the supply chain. So within that inventory balance, it does include product to be delivered. 70 million of outstanding award. but also it includes a fair amount of API so that when there are future orders. We have the ability to be responsive in a very efficient way and in a scale. So we are trying to be proactive, but that amount does also...
Joyce: That discussion still remains to be.
Joyce: Executed or discussed.
Joyce: Dan.
Dan: Yeah. So on the question about inventory and it ties a little bit into us staying in that.
Dan: Given what's happening on the geopolitical front, which is yeah.
Dan: Keeps getting ratcheted up but this has been something that's been building for a series of years in terms of risks and with that we've been trying to be proactive in terms of.
Dan: Having our products throughout the supply chain so within that inventory balance. It does include product to be delivered on that $70 million of outstanding orders.
Dan: But it also includes a fair amount of API.
Dan: That.
Dan: As you can see when there are future orders we have.
Dan: The ability to be responsive in a very efficient way.
Dan: And in this scale manner. So we are trying to be proactive but that amount does also include.
Dan: Cost of product to be delivered under existing orders.
Dan: Okay.
Brian Adams: Okay. And then, um, just asking a very pointed question and not to make anybody difficult. But I want to ask this because it It was a really significant You know, company specific situation. What is the continued, if any, fallout from Dr. Varma in regards to questions from your peers or from NIH or BARDA in regards to efficacy of basically TPOX to treat? you know, uh, the early stages of, you know, MPOCS, um, and, and, I mean, you are and have rightfully, you know, refuted it, but has it, has it impacted sales, I guess? from what you're hearing or seeing.
Dan: And then.
Dan: Just.
Dan: Asking a very pointed question and not to make anybody difficult, but I want to ask this because it.
Dan: It was a really significant.
Dan: Company specific.
Dan: Situation.
Dan: What is the continued if any fallout from doctor.
Dan: Barbara.
Dan: In regards to you.
You know question from your peers or from NIH or BARDA in regards to the efficacy.
Dan: Basically T pax to treat.
Dan: You know.
Dan: The early stages of <unk>.
Dan: Pax.
Dan: I mean, you are and have rightfully you know Ah refuted it but has it.
Dan: Has it impacted sales I guess.
Dan:
Dan: From what Youre hearing or seeing.
Brian: So Brian Thank you for asking I want to start by saying that we have had over a decade of our relationship with BARDA as well as the us and that's from a U S perspective.
Diem Nguyen: Brian, thank you for asking. I want to start by saying that we have had over a decade of This started originally from the co-development of our product to Kiviramat where we have been incredibly transparent and collaborative in terms of our This has then progressed to the procurement of the stockpiles to give... Jay had been at SIGA for less than a year. In terms of his contributions, I would say that it's minimal, if not none. not part of the development of TIGA-BAROMAT and it was not part of the clinical trial. So we stand by our science, we stand by the data, and so do our partners in terms of...
Brian: This started originally from the co development of our product to give you a map, where we have been incredibly transparent and collaborative in terms of our science.
Brian: This has then progressed to the procurement of the stockpile to get there Matt.
Brian: Jay had been as eager for less than a year in terms of his contributions I would say that it's minimal if not none it was not part of the development of ticket Paramount and he was traveling with that part of the clinical trial execution. So.
Brian: So we standby our science, we spend standby the data and and so do our partners in terms of.
Diem Nguyen: that the importance of an antiviral like ticaviramide as well as the preclinical and clinical data that shows it's safe. And finally, the preclinical data that demonstrates.
Brian: That the importance of an anti viral like tick of element as well as the preclinical and clinical data that shows its safety and finally, the preclinical data that demonstrates efficacy.
Speaker Change: Okay, Great and then my final question.
Unknown Speaker: Okay, great.
Brian Adams: And then my final question. And I applaud you for making the deal, I guess, with VaynerBuild a few months back. But with the cash... War Chess that you've got, I mean...
Speaker Change: And I applaud you for making the deal I guess with Vanderbilt a few months back but.
Speaker Change: With the cash.
Speaker Change: Yes.
Speaker Change: War chest that you've got I mean.
Diem Nguyen: It would be my recommendation as a shareholder and a, you know, a portfolio manager that you and you're probably already looking at this, but. Unknown Speaker To build out yourselves, you know, beyond, you know, arguably one or two trick ponies, so to speak, or stable. Are there other In either drugs or bioterrorism, prophylaxis portfolios or drugs that you're looking at right now that you can. Tuck into your portfolio that would be another source of potential revenue and or income for you down the line.
Speaker Change: It would be my recommendation as a shareholder and you know.
Speaker Change: Portfolio manager that you and you probably already looking at this but.
To build out yourselves you know beyond you know arguably one or two trick pony so to speak or stable.
Speaker Change: Are there other.
Speaker Change: You know either.
Speaker Change: You know drugs or.
Speaker Change: Bioterrorism prophylaxis.
Speaker Change: Our portfolio is for drugs that youre looking at right now, but you could truck.
Speaker Change: Tuck into your portfolio.
Speaker Change: <unk> would be another source of potential revenue and income for you down the line.
Speaker Change: So Brian I would actually say that coming into seeger, almost a year ago. One of the priorities I have is to maximize the cheap Pax franchise.
Diem Nguyen: Brian, I would actually say that. to SIGA almost a year ago, one of the priorities I have is to maximize Franchise, which includes. Global Transcription by Trans-Expert at Fiverr.com from a registration perspective, but the second aspect is looking at potential diversification of the pipeline. We saw the active, the degree of activity we had pursued in 2024. I'd like to continue to pursue. 5, Portfolio Diversification.
Speaker Change: It includes the global expansion from a registration perspective, but the second aspect is looking at potential diversification of the pipeline.
You saw the actor.
Speaker Change: The degree of activity, we have pursued in 2025 four I'd like to continue to pursue in 2025 portfolio diversification exactly to your point.
Speaker Change: Okay. Thank you very much that's all I have I appreciate it thank you very much.
Brian Adams: Okay, thank you very much. That's all I have. I appreciate it. Thank you very much.
Speaker Change: There are no further questions at this time I will now turn the call back to Zhang Please continue.
Operator: There are no further questions at this time.
Diem Nguyen: I will now turn the call back to Jem. Please continue.
Speaker Change: Yeah.
Zhang: So I wanted to thank everybody for their time today and joining us for today's call and for your ongoing interest in Cedar. We look forward to speaking to you again in our first quarter call have a good rest of your evening. Thank you.
Diem Nguyen: So I wanted to thank everybody for their time today and joining us for today's call and for your ongoing interest in SIGA. We look forward to speaking to you again in our first quarter call. Have a good rest of your evening.
Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
Zhang: Yeah.
Zhang: [noise] [noise].
Zhang: Okay.
Zhang: Okay.
Zhang: [music].
Zhang: No.
Zhang: Yeah.
Zhang: Okay.
Zhang: [music].
Zhang: Okay.