SIGA Technologies Third Quarter 2026 Earnings Call - SIGA TECHNOLOGIES INC

Welcome to the SEGA Business Update Call. Before we turn the call over to SEGA management, please note that any forward-looking statements made during this call are based on management's current expectations and observations and are subject to risks and uncertainties that could cause actual results to differ from forward-thinking statements. SEGA does not undertake any obligation to update publicly any forward looking statement to reflect events or changed circumstances after this call. For a discussion of factors that could cause results to differ, please see the company's filings with the Securities and Exchange Commission, including without limitation the company�s annual report on Form 10-K for the year ended December 31, 2025, and its subsequent reports on Form 10-Q and Form 8-K. With that, I will turn the call over to Zem Nguyen, Chief Executive Officer of SIGA. Zem? Good afternoon, everyone, and thank you for joining today's call to review our business results. I am joined by Dan Luxhire, our Chief Financial Officer, and we appreciate this opportunity to provide an update on our company. After the update, we'll take your questions. Throughout 2026, SICA has continued to execute on its core mission of working alongside governments to build and sustain long-term preparedness against potential biological threats, namely smallpox. We remain committed to positioning our smallpox therapeutic TPOCs for rapid, large-scale deployment should an outbreak occur. As a reminder, in the second quarter, we completed our final product delivery under the BARDA 19C contract, fulfilling all our product obligations under that agreement. We're proud of this partnership, proud of how we performed, and proud to have played an important role in strengthening the U.S. government smallpox preparedness. We believe the case for preparedness against biological threats remains strong. Geopolitical tensions and advances in technology, including AI, are reshaping the threat landscape. Mitigating these risks requires proactive, sustained government investment in medical countermeasures stockpiles. In an emergency, ready access to medical countermeasures is essential to protect both civilians and warfighters. At the same time, a compelling case for preparedness does not always translate into predictable procurement. As we discussed during our last call, the process to secure a new U.S. government contract has progressed more slowly than in the past, and the timing of an award remains uncertain. Even so, we remain confident that TPOCs has an important role in our nation's preparedness plans, and that national security for medical countermeasures remain important to the U.S. government. Despite the lack of certainty as to timing and details, based on our discussions with key stakeholders, we continue to believe that a new procurement contract will be awarded. Turning to our international business, I'd like to share news of recent contracts that advances our efforts to maintain a diverse revenue stream and customer base. Last month, we signed a contract to supply oral teapots to Canada's Department of National Defense, or CDND, over the next five years. This contract is valued up to approximately $15 million. It includes firm commitments about $9 million over the first three years, plus up to $6 million in options exercisable at CDND's discretion. This is CDND second teapot contract, the first awarded in April of 2020 for the purchase up to approximately $14 million of teapots was completed in 2025. Canada continues to be one of the leaders in smallpox preparedness among our international customers, and we believe this award reflects that commitment. It also highlights another important point. In a public health emergency, the men and women of the armed forces are often among the first called on to respond. So making sure they have access to smallpox antiviral is a key part of being prepared. Beyond this contract, we are continuing in advance discussions with other international customers, including one which we are in late-stage negotiations. We look forward to providing an update at the appropriate time. Moving to our development activities, I'd like to provide an update on our pediatric formulation and post-exposure prophylaxis, or PEP, programs. We continue to expect results from phase one study of our pediatric formulation by year end, and those results will inform next steps. If successful, this formulation, together with the oral and IV formulations, would extend TPOX coverage across the full population, from infants to adults. Children are among the most vulnerable in an outbreak and an improved pediatric formulation will give governments a more complete solution for their stockpiles. On the PEP program, we continue to work closely with our partners at the Department of War, FDA, and CDC, all of whom remain highly engaged with this program. We recently met with the FDA to review the program, including the immunogenicity sample analysis the CDC plans to conduct. At that meeting, the FDA is asked to perform additional validation and related laboratory work to help ensure the accuracy of results from the sample analysis. This work is important and requires time, and as a result, we now expect to file our supplemental NDA in 2028. While this delay is disappointing, it does not change our view on the relevance of this program. In an outbreak, the ability to use TPOXX as a PEP for our military, first responders, and others exposed to smallpox virus can help save lives. Regarding our financial results, as I said in prior calls, our business is subject to inherent quarter-to-quarter variability, so our results are best viewed over a longer horizon than any single period. Over the first nine months of the year, product revenues totaled approximately $42 million, including sales to the U.S. government and customers in Asia-Pacific region and Europe. That breadth, together with the new CD&D contract I talked about earlier, reflects the continued commitment of governments around the world to smallpox preparedness. Before I turn the call over to Dan, I want to recognize Dennis Herbe, our Chief Scientific Officer, who is retiring today after three decades with CIGA. When Dennis joined us in 1996, there was no approved treatment for smallpox. Today, T-POX is approved in the U.S., Canada, the European Union, the U-K, and Japan. It has been sold to more than 30 countries and is maintained in stockpiles around the world. Dennis' scientific leadership shaped the achievement at every step, from early-stage research through approval. On behalf of everyone at SIGA, I want to thank Dennis for his contributions to our company and to global health security. We're very pleased that he will continue to support us in an advisory role. In closing, SIGU has always been guided by its mission to ensure governments are prepared to protect their citizens from smallpox, and that mission is unchanged. While procurement processes are not predictable, we stand ready to work with our governments around the world, and we do so with a strong balance sheet, including $116 million in cash and no debt at the end of the quarter. As I said at the start of the call, we believe the case for preparedness remains strong. Smallpox and other high-consequence threats are serious, and emerging technologies have a potential to lower barriers to creating or misusing biologic agents. But with preparation, these threats can be mitigated, and TPOCs has a long history of helping governments meet smallpox threats. With that, I'll turn over to Dan to review our financial results in more detail. Dan? Thanks, Zen. As noted earlier in the call, the company's product-related revenues are $42 million for the nine months into September 30, 2026, with most of the revenues being recorded in the second quarter, reflecting the variable rhythm of SIGA's business model. Year-to-date product revenues include approximately $26 million of IV TPOCs deliveries to the U.S. Strategic National Stockpile and approximately $13 million of international sales to two international customers. For the third quarter, there are no product sales to customers. In addition to product-related revenues for the nine months ended September 30, 2026, The company also has research and development revenues of approximately $7 million. Of this total, approximately $1 million of the research and development revenues were earned in the third quarter. Pre-tax operating income for the nine months into September 30, 2026, which excludes interest income and taxes, is approximately $2 million. For the quarter, pre-taxe operating loss is approximately$7 million, net income for for the nine months ended September 30th, 2026 is approximately $6 million. For the quarter, net loss is approximately 3 million dollars. In turn, fully diluted income per share for the 9 months ended September 30, 2036 is 9 cents per share, while fully dilute loss per share for the quarter is 4 cents per share. The company continues to maintain a strong balance sheet. September 30th, 2026, the company had a cash balance of approximately $116 million and no debt. This concludes the financial update. At this point, I'll turn the call back to Zim. Thank you, Dan. With that, we'd like to open the call for questions. Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star key followed by the number one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star key followed by the number two. One moment, please, while we assemble the queue. Your first question comes from Yoti Prakash of Edison Group. Please go ahead. Hi, good evening. Thank you for taking my questions. First of all, congratulations on the recent contract from the CD&D. I just want to understand if this is the international opportunity which was highlighted during the Q2 call, and if there's another order still under discussion, because you did mention that you're in conversations. So if there is an order in discussion, can we hear about it during the remainder of the year? And going back to the CD&D order, can you provide some color on the delivery schedule, particularly if we can expect anything to be delivered within 2027? Hi, Jody. This is Dan. Thanks for the question. I'll answer this one. On the first part of your question yes the October contract is the opportunity that we've referenced last quarter now also in your question you asked about well is there another order and as noted in our prepared remarks we are in it there is another order we are in advanced stages for another international contract and on that we we'll provide details at the appropriate time and then toward the end of your question you're talking about sort of cadence of delivery and so with regard to that the way the contract is set up is the firm orders are structured so that Sega would deliver an equal number of oil teapots courses in each of the first three fiscal years of the contract now I want to note that given that the Canadian fiscal year goes from April to March. This could result in two deliveries within one calendar year and I wanted to also highlight that deliveries are expected to start in 2027. Now the contract has the firm orders I just talked about and also has options. With respect to the options, courses can be ordered and delivered at any point in time during the five-year contract and And that's at the discretion of the Canadian military. Thank you, Dan. That was very useful. And my second question relates to recent developments and something which has been on people's mind is the results of the U.S. midterm elections. Now, do you foresee any implications of the results on biodefense funding, priorities, and possibly the timing of the U.S. RFP? Hi, Josie. This is Em. Nice to hear your voice, and thanks for joining the call on this question. I would say historically there has been bipartisan support for biodefense, and quite frankly, biodeference is not a large or controversial budget line item, which means we don't currently expect a change in direction regarding congressional funding for biodefense. As it relates to the new contract process, we currently do not believe that midterm results will have any material impact on the nature or trajectory of this process beyond the typical transition period that follows any election. Great, thank you, Sam. And just going back to international growth, we noticed that Bavarian Nordics recently secured a four-year smallpox vaccine contract with the UK government. Now, are you also seeing broader momentum in European preparedness, spending, and also greater interest in TPOX? And the reason we're asking this is because recently the NPOX label was removed in Europe. So do you see any sort of implications of this on your recent discussions with the European authorities? Thanks Josie. So Europe, like many countries and continents, go through multi-year transformational in terms of national security priorities and spending. In this particular environment, each country has its own dynamics and priorities and is moving at its own pace. Overall, yes, we do believe that there's increased focus on biodefense and smallpox preparedness. This has resulted in the spending like the U.S. – sorry, this has resulted in spending like the U-K contract you just mentioned. I would say historically, though, smallpox preparedness across Europe has largely been vaccine-centric. Part of our work supporting a shift towards a more comprehensive approach that pairs vaccines with anti-virus, very much similar to the U S model, but we do recognize that changing this paradigm takes time, specifically And for TPOCs, we are part of evolving conversations on stockpiling, both at the country and regional level. Now, Josie, for your second question, on our European label, in certain cases, the change does require some additional discussion. While this can affect timing, we do not believe it changes the long-term opportunity in Europe for smallpox stockpilings. Notably, just as a gentle reminder, we recently renewed our TPoC filings both in Europe as well as in the UK for the treatment of smallpox, and we really look forward to working with our European counterparts in our preparedness efforts. That's very helpful. Thanks, Sam. No further questions from my side. There are no further questions at this time. I will now turn the call back over to Zem Nguyen. Please continue. Thank you. Today, I'd like to thank everybody for making time to join us on today's call and for your ongoing interest in SIGA. We look forward to speaking with you again next quarter. Have a good evening. Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.