SIGA Technologies Q4 2024 Earnings Call Transcript

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March 11, 2025

There are 5 speakers on the call.

Operator

Welcome to the CIGA business update call. Before we turn the call over to CIGA 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. CIGA does not undertake any obligation to update publicly any forward looking statements to reflect events or changed circumstances after this call. For a discussion of factors that could cause actual 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 ks for the year ended 12/31/2024 and its subsequent reports on Form 10 q and Form eight ks.

Operator

With that, I will now turn the call over to Zem Nguyen, Chief Executive Officer of CIGA. Zem, please go ahead.

Speaker 1

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 Luxhire, 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'm pleased to share that 2024 was a year of impactful execution and strong financial performance for CIGA. In 2024, we also made considerable progress on several initiatives to drive shareholder value, including one, continue our partnership with the U.

Speaker 1

S. Government two, advancing regulatory approvals for TPOXX and three, cultivating strategic partnerships to expand global access to TPOXX. With product sales of $133,000,000 up approximately 2% from 2023, we delivered the second consecutive year of product sales growth, reinforcing the critical role that TPOXX and a comprehensive smallpox preparedness program play in strengthening national security. Additionally, our results highlight the strength of our financial position. Of the $133,000,000 in product sales, about $80,000,000 was generated in the fourth quarter from a diverse mix of revenue sources, led by deliveries of oral and IV TPOXX to this U.

Speaker 1

S. Strategic national stockpile. This was followed by deliveries of both oral and IV TPOXX to the U. S. Department of Defense and deliveries of oral TPOXX in an international markets.

Speaker 1

The latter included a notable sale in East Asia for $11,000,000 of oral TPOXX, which is more than double the size of the largest prior individual TPOXX sale in the region. This latest international milestone follows the first sale of TPOXX 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.

Speaker 1

Two examples stand out. First, midway through 2024, our company assumed responsibility for promoting TPOXX 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.

Speaker 1

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 markets. 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 TPOXX for the treatment of a broad range of orthopox viruses. This approval marked another important milestone in our efforts to expand access to TPOXX. Additionally, it coupled with a growing sales of TPOXX in East Asia reinforces the value of antiviral stockpiling to ensure supply resilience during immediate crisis response to safeguard communities and individuals against smallpox.

Speaker 1

To obtain this approval and in collaboration with our local partner Japan Biotechno Pharma, 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 orthopox virus 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 Orthopox viruses, 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 TPOXX franchise and provide patients with additional therapies in this space. While monoclonal antibodies represent an early stage component of our pipeline, our TPOXX post exposure prophylaxis program for smallpox or PEP is far more advanced.

Speaker 1

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 twenty twenty six. In addition to our successes, we've also faced some challenges this year given the POM-seven and STOMP clinical trial results in MPoX.

Speaker 1

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 TPOXX that I'd like to address today. By the way of background, TPOXX 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, EPOX 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 one hundred and ninety million people were born after the end of the routine vaccination, leaving these Americans vulnerable.

Speaker 1

Additionally, the robustness of the immune response in those vaccinated more than fifty years ago cannot be determined. As such, the potential for its intentional reintroduction remains a serious concern. For POM-seven and STOMP, Tega donated the product to trial sponsors to help advance mPox research and support response to the twenty twenty two 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 TPOXX and those receiving placebo. While these studies did not show statistical significance difference between ticavirimat and placebo at this primary endpoint, the POM-seven results did signal potential benefits for patients treated early or with severe disease.

Speaker 1

Generally speaking, viruses replicate faster in the initial stages of infection and administrating antivirals early helps curve virus replication before reaching its peak load, thereby reducing the severity of the disease. This principle was exemplified during the COVID-nineteen pandemic where timely administration of antivirus proved critical improving patient outcomes. The same principle applies to TPOXX. Tecovirimat works to reduce viral release from infected cells. Based upon Tecovirimat's mechanism of action, we believe treatment would be optimized when administered early in symptoms or ideally post exposure prophylaxis.

Speaker 1

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 POM-seven, we saw the potential benefits for patients treated early or with severe disease. We're currently assessing viral load impact in MPoX patients over time as we expect reduction in virus load with ticavirimat administration early consistent with our non human primate models. Both POM-seven and STOMP enrolled patients at later stages of disease, a medium about five point nine and eight days respectively after self reported symptom onset.

Speaker 1

We believe these trials are not necessary reflective of how or when the drug should be used based on its mechanism to action and potential value in smallpox outbreak. We believe TPOXX remains a vital countermeasure for reducing mortality from smallpox. In a comprehensive preparedness plan, antivirus provide a critical line of defense. Complementing vaccines, antivirus can be used to treat an infection in patients who have not been vaccinated or do not benefit from vaccination. Current antivirals have the potential to prevent onset of viral illness after exposure to the virus.

Speaker 1

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 disaster strikes. Looking forward, we believe securing a new contract for the continuing supply of TPOGS to the strategic national stockpile or SNS represents an opportunity to enhance our company's long term potential and help advance our national securities or bioterrorism preparedness. Since the new U. S.

Speaker 1

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 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 new contract for TPOC.

Speaker 1

As a reminder, ASPR is within the U. S. HHS and houses the center of the Biomedical Advanced Research and Development Authority or BARDA and the SNS. For reference, CIGA has been providing TPOXX 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 anti biotherapies to treat smallpox.

Speaker 1

Furthermore, our current ITC 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.

Speaker 1

Our disciplined approach to capital management gives us optionality. Our TPOCS 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 opportunities ahead. With that, I'll turn it over to Dan to review the financial results in more detail.

Speaker 2

Thanks, Zim. As noted earlier in the call, CIGA's product sales for this year surpassed year sales. This represents the second straight year sales growth and a new high watermark for annual sales since FDA approval of TPOXX in 2018. Product revenue for full year 2024 was $133,000,000 Of this amount, $80,000,000 was recognized in the three months ended 12/31/2024. In the fourth quarter, '50 '1 million dollars of oral TPOXX and $9,000,000 of IV TPOXX was delivered to the strategic national stockpile or SNS.

Speaker 2

Dollars nine million in most of the oral TPOXX and a small amount of IV EPOX was delivered to the U. S. Department of Defense and there was an $11,000,000 sale to an international customer in the East Asia region. To reiterate a comment made earlier in the call, the international sale in the fourth quarter represents a milestone and 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 $133,000,000 amount comes from a diverse mix similar to the diversity in the fourth quarter.

Speaker 2

The revenue mix includes $74,000,000 of oral EPOC sales to the S and S, twenty six million dollars of IV EPOC sales to the S and S, ten million dollars of oral and IV EPOC sales to the U. S. Department of Defense and $23,000,000 of oral TPOXX sales to 13 international customers. In addition to product related revenues, the company also had research and development revenues. For the three and twelve months ended 12/31/2024, research and development revenues were $1,600,000 and $5,400,000 respectively.

Speaker 2

Pretax operating income, which excludes interest income and taxes was approximately $57,000,000 for the three months ended 12/31/2024. For the full year twenty twenty four, pretax operating income was approximately $70,000,000 In comparison, there's a pretax operating income for the three and twelve months ended 12/31/2023 of approximately $92,000,000 and $84,000,000 respectively. I would like to note that differences between pretax operating income margin in 2024 and 2023 reflects different product mixes in those periods. Net income for the three months ended 12/31/2024 was approximately $46,000,000 For the twelve months ended 12/31/2024, net income was approximately $59,000,000 In turn, fully diluted income per share for the three months ended 12/31/2024 was $0.63 and for the full year 2024, fully diluted income per share was $0.82 Throughout 2024, the company continued to maintain a strong balance sheet through an abiding commitment to financial discipline. At 12/31/2024, the company had a cash balance of $155,000,000 and no debt.

Speaker 2

Looking forward to 2025, I would like to note that we had a $70,000,000 outstanding order balance at 12/31/2024, which we expect to deliver in 2025. This concludes the financial update. At this point, I'll turn the call back to Zen.

Speaker 1

Thank you, Dan. With that, we would like to open the call for questions.

Operator

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Your first question comes from the line of Jyoti Prakash from Edison Group. Your line is now open. Hi.

Speaker 3

Thank you for taking my questions. My first question relates to oral TPOXX deliveries. We understand that around $60,000,000 has been delivered from the most recently exercised BARDA 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.

Speaker 3

S. Authorities?

Speaker 1

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

Speaker 2

Yes. Thanks for the question, Jody. As noted in our prepared remarks, we had $70,000,000 of outstanding orders at 12/31/2024. Most of these orders mostly consist of remaining deliveries of oral and IV TPOXX to the SNS under existing orders. We currently expect those deliveries to start in the second quarter based on coordination with the United States government, and we expect all $70,000,000 of the outstanding orders to be delivered in 2025.

Speaker 2

There's one 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, the RFP timing is not impacted by the delivery timing. Just wanted to make that clear.

Speaker 3

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 $155,000,000 Can we expect you to announce another special dividend this year as you've been doing every year since 2022?

Speaker 2

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 that which we regularly review.

Speaker 2

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 2022 and 2023, the Board of Directors declared special cash dividends in May, which were paid in June. And then in 2024, the special cash dividend was declared in March as it was paid in April.

Speaker 2

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.

Speaker 3

Great. My next question relates to your international growth. First of all, congratulations on receiving the regulatory approval in Japan for TPOXX. Can you provide some more details in terms of your distribution agreement with Japan Bio Techno Pharma? And just to follow-up on that, you made $11,000,000 of international sales in the last quarter.

Speaker 3

Does that relate to delivery to Japan's strategic national stockpile?

Speaker 2

Right, right. So on the first part of the question, the terms of the distribution agreement with Japan by Techno Pharma or JBP, Those terms have not been disclosed. What we can say though is that the distribution agreements with JBP or within other countries, they're 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.

Speaker 2

On the second part of that question in terms of the $11,000,000 international sale, right now at this time we're not currently disclosing that customer. As mentioned in the prepared remarks, customers located in the East Asia area, but we're not disclosing the specific customer.

Speaker 3

Thank you for that. I have another couple of questions. So the next one is related to the NPOXX opportunity. How do you see that evolving given the results from the PAM-zero-seven in STORM trials? We We understand that there were subsets, which a subset of patients, which who saw good results in the PAM-seven trial.

Speaker 3

So is there any plan to adjust the design of the remaining trials to focus on these particular subset of patients?

Speaker 1

Jody, thanks for that question. I'll take this one. Just a overarching concept. We are continuing to work with NIAID. They are specifically the POM seven and STOMP trial sponsors.

Speaker 1

We are working with them to fully analyze the clinical data, including reviewing data for certain subgroups as you mentioned to determine what types of patients may potentially benefit the most from cicaviramat as well as the optimal treatment regimen. 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. 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 POM seven.

Speaker 1

These trials are not designed by CEGA and they were not designed with a drug development in mind. As the result, we express some of the limitations associated with the mechanism. Antivirals generally work based on how their mechanism is executed. Tecovirimat specific mechanism, the typical patient profile, the design of the trials, it's not unexpected these trials do not meet their primary endpoint to full resolution of all lesions. As with the case of STOMP and POM seven, CIGA 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 1

However, saying that Jody, we will continue to evaluate the potential benefit of tecovirimat treatment in EPOX patients and then design and execute on further studies accordingly.

Speaker 3

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 TPOXX?

Speaker 1

Thanks, Jody. We can only speak on the behalf of CIGA. First and foremost, I would say that CIGA 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.

Speaker 1

And these relationships naturally evolve following changes in leadership from an administration perspective. 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. 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 1

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 RP for a new contract for TPOXX. At this time, any further comment would be purely speculative in nature.

Speaker 3

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

Speaker 1

Thanks, Jody.

Operator

Your next question comes from the line of Brian Adams from Parker Cargo Terry. Your line is now open.

Speaker 4

Thank you very much and great gear. A couple of quick questions, on the kind of the process of reengaging with Florida and potentially again blue skies, 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 $550,000,000 5 70 5 million dollars of the original contract six years ago. Where do you think we stand on this? Are we the fourth inning, fifth inning, you had kind of alluded to, Ma'am, Doctor.

Speaker 4

Wynne that would some kind of decision would be made this year. Would there be a COLA increase, maybe a number in the $700,000,000 to $800,000,000 range? That's my first question. And then secondly, the inventory that's on the book shows $49,000,000 What exactly is that? Is that the value of the drug on your that can be deployed, and I'm assuming that will meet a portion of the $70,000,000 of the legacy contract that still needs to be filled.

Speaker 4

So those are my first two questions.

Speaker 1

Hi, Brian. Thanks for the thoughtful questions. I will target the first section and then let Dan talk to you through with the inventory. The first and foremost, I would start by saying that we have tikimivirimat and its primary treatment of choice for smallpox. There is a continued reinforcement of this importance to the U.

Speaker 1

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 today. I can only say based on the macro dynamics that we're facing in our environment today the smallpox threat continues to increase.

Speaker 1

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?

Speaker 2

Yes. So on the question about inventory and it ties a little bit into what Zen 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 risk. 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 $70,000,000 of outstanding orders. 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 manner.

Speaker 2

So we are trying to be proactive, but that amount does also include cost of product to be delivered under existing orders.

Speaker 4

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 company specific situation. What is the continued if any fallout from Doctor. Varma in regards to questions from your peers or from NIH or BARDA in regards to the efficacy of basically TPOXX to treat the early stages of MPoX. And I mean you are in half rightfully refuted it, but has it impacted sales I guess from what you're hearing or seeing?

Speaker 1

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 SNS from a U. S. Perspective. This started originally from the co development of our product tucovirimat where we have been incredibly transparent and collaborative in terms of our science.

Speaker 1

This has then progressed to the procurement of the stockpile of tucovirimat. Jay had been at Zika 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 tecovirimat and he certainly 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 takaviramat as well as the preclinical and clinical data that shows its safety and finally the preclinical data that demonstrates efficacy.

Speaker 4

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 a portfolio manager that you and you're probably already looking at this, but to build out yourselves beyond arguably one or two trick pony, so to speak, or stable, are there other either drugs or bioterrorism, prophylaxis portfolios or drugs that you're looking at right now that you could tuck into your portfolio that would be another source of potential revenue and or income for you down the line?

Speaker 1

So Brian, I would actually say that coming in to Zika almost a year ago, one of the priorities I have is to maximize the PPOCS 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.

Speaker 4

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

Speaker 3

Thanks, Glenn.

Speaker 4

There are

Operator

no further questions at this time. I will now turn the call back to Zem. Please continue.

Speaker 1

So I wanted to thank everybody for their time today in joining us for today's call and for your ongoing interest in CIGA. We look forward to speaking to you again in our first quarter call. Have a good rest of your evening. Thank you.

Operator

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

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