SIGA Technologies Inc.

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 results to differ materially from the forward-looking statements. SIGA does not undertake any obligation to update publicly any forward-looking statements to reflect events or change circumstances after this call. For a discussion of factors that could cause actual results to differ, PC 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. With that, I will now turn the call over to Zem Nguyen, Chief Executive Officer of SICA.

Zem, please go ahead.

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. I am 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 deliver 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. 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 TPOCs to the U.S. Strategic National Stockpile. This was followed by deliveries of both oral and IV TPOCs to the U.S. Department of Defense and deliveries of oral TPOCs in international markets. 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. 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 TPOCs 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've 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. We believe our conversations and actions will yield positive results over time. 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 TPOX. 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 Biotechnopharma, we submitted a robust data package, which included studies involving healthy human volunteers, non-human primates, and rabbits. No other drug approved to treat smallpox or any other orthopoxvirus is supported by such a comprehensive and extensive data package. 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 TPOX franchise and provide patients with additional therapies in this space. While monoclonal antibodies represent an early stage component of our pipeline, our TPOX 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. 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. Based upon their projected timeline, we are now targeting an FDA submission for the PEP indication in early 2026. In addition to our successes, we've also faced some challenges this year given the POM007 and STOMP clinical trial results in MPOCS. While the results of these trials were not a surprise given the mechanization of TPOCs and the design of the trials, they have led to some important discussions about TPOCs that I'd like to address today. By the way of background, TPOX 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, TPOX is supported by extensive studies demonstrating its safety and efficacy in reducing mortality from smallpox. Since smallpox vaccination programs were discontinued several decades ago, herd immunity has diminished. leaving populations vulnerable to its potential reintroduction. For example, in the US, 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 its intentional reintroduction remains a serious concern. For POM007 and STOMP, TIGA 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. While these studies did not show statistical significance difference between ticavirumab 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. 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 TPOX. Ticovirumab works to reduce viral release from infected cells. Based upon Ticovirumab's mechanism of action, we believe treatment would be optimized when administered early in symptoms, or ideally post-exposure prophylactics. The early phase of disease includes viral implication 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 MPOCS patients over time, as we expect reduction in virus load with tic of aromat 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. 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 CPOX 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. Strategic stockpiling of antivirals helps ensure a swift, coordinated response when disasters strike. 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 bioterrorism 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. 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 TPOCs. As a reminder, ASPR is within the USHHS and houses the center of the Biomedical Advanced Research and Development Authority, or BARDA, and the SNS. For reference, SEGA has been providing TPOCS to the ASPR for more than a decade, and national security is an issue that transcends political considerations. 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. With this in mind, we stand ready to negotiate with the new ASPR with the objective of completing a new contract in 2025. In summary, this is a dynamic time for CIGA. 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. In short, with a strong foundation, we believe we are well positioned for the future and the opportunities ahead. With that, I'll turn it over to Dan to review the financial results in more detail.

Thanks, Em. As noted earlier in the call, FIGA'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 TPOCs in 2018. Product revenue for full year 2024 was $133 million. Out of this amount, $80 million was recognized in the three months ended December 31st, 2024. In the fourth quarter, $51 million of oral TPOX and $9 million of IV TPOX was delivered to the Strategic National Stockpile, or SNS. $9 million of mostly oral TPOX and a small amount of IV TPOX was delivered to the U.S. Department of Defense, and there was an $11 million 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 TPOC 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 oil 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. Department of Defense, and $23 million of oral TPOC sales to 13 international customers. In addition to product-related revenues, the company also had research and development revenues. For the three N12 months ended December 31st, 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 three and 12 months ended December 31st, 2023 of approximately $92 million and $84 million, respectively. I would like to note that differences between pre-tax operating income margin in 2024 and 2023 reflects different product mixes in those periods. Debt income for the three months ended December 31st, 2024 was approximately $46 million. For the 12 months ended December 31st, 2024, net 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. 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 balance at December 31st, 2024, which we expect to deliver in 2025. This concludes the financial update. At this point, I will turn the call back to Zen.

Thank you, Dan. 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 one 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 two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. 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 T-box 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?

Thanks, Jodi. I'll let Dan answer that question.

Yeah, thanks for the question, Jody. As noted in our prepared remarks, we had 70 million of outstanding orders at December 31st, 2024. These are most of these orders or these orders mostly consists of remaining deliveries of oral and IV tepox to the SNS under existing orders. We currently expected 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. At the very end, you mentioned the RFP, and I guess just to make sure for clarity purposes, just to highlight that the RFP process is a separate process from the delivery process under the 19C contract. And in fact, you know, the RFP timing is not impacted by the delivery timing. Just wanted to make that clear.

Thanks a lot. That's really helpful. 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 meant to be dynamic and tailored to optimize positive outcomes for our shareholders, both in the short term, balancing the short term and the long term. This approach has been used over the past series of years. And so with that, the timing of a special cash dividend each year, it's influenced by several factors which we regularly review. Some of the factors include cash flow performance, capital allocation priorities, external market conditions. 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, the special cash dividend was declared in March, and it was paid in April. So there's some movement in terms of timing. 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 in the second quarter, which is consistent with the timing for most prior years.

Great. My next question relates to your international group. First of all, congratulations on receiving the regulatory approval in Japan for TPOX. Can you provide some more details in terms of your distribution agreement with Japan Biotechnopharma? And just to follow up on that, you made $11 million of international sales in the last quarter. Does that relate to delivery to Japan's strategic national stockpile?

Right, right. So on the first part of the question, the terms of the distribution agreement with Japan Biotechnopharma, or JVP, those terms have not been disclosed. What we can say, though, is that the distribution agreements with JVP or within other countries are different in nature than the promotion agreement we had with Meridian. And the key point here is that distribution agreements will not have the same level of fees that were paid to Meridian. It's a much more efficient model and financially better for us. 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. As mentioned in the prepared remarks, the customer is located in the East Asia area, but we're not disclosing the specific customer.

Thank you for that. 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 PALM 007 and STORM trials? We understand that they were subsets of patients who saw good results in the PALM007 trials. So is there any plan to adjust the design of the remaining trials to focus on these particular subset of patients?

Jodi, thanks for that question. I'll take this one. Just an overarching concept, we are continuing to work with NIAID They are specifically the PALM007 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. The primary objective was to provide access from a humanitarian perspective. That was particularly consistent in the POM007. These trials were not designed by CIGA and they were not designed with a drug development in mind. As the result, we expressed some of the limitations associated with the mechanization. Antivirals generally work based on how their mechanization is executed. Ticovirumab's 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. However, saying that, Jodi, we will continue to evaluate the potential benefit of ticavirumab treatment in MPOC patients and then design and execute on further studies accordingly.

Great. That's super helpful. 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 TPOX?

Thanks, Jodi. 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 perspective. For now, our focus remains on maintaining strong partnerships and continuing to play an important role in supporting the U.S. national security and public health initiatives. 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. 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 the RFP for a new contract for TPOX. At this time, any further comment would be purely speculative in nature.

Okay. Thank you so much. No further questions, and congratulations again on the strong quarter. Thanks, Jody.

As a reminder, if you have a question, please press star 1 on your telephone keypad. 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 gear. A couple quick questions. On the kind of the 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 $555 or $75 million of 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, Dr. Winn, that some kind of decision would be made this year. Would there be a COLA increase, maybe a number in the $700 million 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 the value of the drug that can be deployed? And I'm assuming that will meet a portion of the $70 million of the legacy contract that still needs to be filled. So those are my first two questions.

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 S&S in terms of ticumvirumab and its primary treatment of choice for smallpox. There is a continued reinforcement of this importance to the U.S. government from a preparedness perspective. We have talked quite a bit about manufacturing strategies as well as potential volume. However, Brian, we have not identified a specific range of volume to date. I can only say, based on the macro dynamics that we're facing in our environment today, that the smallpox 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, we think that this is certainly an important time to reflect on the volume requirements. That discussion still remains to be executed or discussed. Dan?

Yeah, so on the question about inventory, and it ties a little bit into what Dan was saying in that, given what's happening on the geopolitical front, which is it 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 having products throughout the supply chain. So within that inventory balance, it does include product to be delivered on that 70 million of outstanding orders. But also, it includes a fair amount of API so that, you know, when there are future orders, we have the ability to be responsive in a very efficient way and in a scale manner. So, we are trying to be proactive, but that amount does also include cost of product to be delivered under existing orders.

Okay.

And then, just, asking a very pointed question and not to make anybody difficult, but I want to ask this because it was a really significant, you know, company-specific situation. What is the continued, if any, fallout from Dr. Varma in regards to, you know, questions from your peers or from NIH or BARDA in regards to the efficacy of basically TPOCs to treat the early stages of MPOCs. I mean, you are and have rightfully refuted it, but has it impacted sales, I guess, from what you're hearing or seeing?

So, Brian, thank you for asking. I want to start by saying that We have had over a decade of a relationship with BARDA as well as S&S from a U.S. perspective. This started originally from the co-development of our product to Gaviramat where we have been incredibly transparent and collaborative in terms of our science. This has then progressed to the procurement of the stockpile to Gaviramat. Jay had been at Sego for less than a year in terms of His contributions, I would say that it's minimal, if not none. He was not part of the development of tigavirumab, and he was not part of the clinical trial execution. So we stand by our science, we stand by the data, and so do our partners in terms of the importance of an antiviral like tigavirumab, as well as the preclinical and clinical data that shows its safety, And finally, the preclinical data that demonstrates efficacy.

Okay, great. And then my final question, and I applaud you for making the deal, I guess, with Vanderbilt a few months back, but with the cash war chest that you've got, I mean, it would be my recommendation as a shareholder and, you know, portfolio manager that you and you're probably already looking at this but You know to build out yourselves, you know beyond, you know, arguably one or two trick ponies so to speak or stable Are there other? you know either You know drugs or you know bioterrorism, you know prophylaxis Portfolios or drugs that you're looking at right now that you could tuck into your portfolio and that would be another source of potential revenue and or income for you down the line.

Brian, I would actually say that coming into SIGA almost a year ago, one of the priorities I have is to maximize the TPOC franchise, which includes global expansion from a registration perspective. But the second aspect is looking at potential diversification of the pipeline. You saw the active... the degree of activity we had pursued in 2024. I'd like to continue to pursue in 2025 portfolio diversification exactly to your point.

Okay. Thank you very much. That's all I have. I appreciate it.

Thank you very much.

There are no further questions at this time.

I will now turn the call back to Zem.

Please continue.

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. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Thank you.