SIGA

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 from the forward-looking statements. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or changes 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 31st, 2025, and its subsequent reports on Form 10-Q and Form 8-K. With that, I will turn the call over to Diem Nguyen, Chief Executive Officer of SIGA. Diem?

Good afternoon, everyone, and thank you for joining today's call and review of our business results. I'm joined by Dan Luckshire, our Chief Financial Officer, and we appreciate this opportunity to provide an update on our company. After the update, we'll be happy to answer your questions. SIGA's focus remains unchanged, partnering with governments around the globe to build and strengthen long-term preparedness strategies against potential biological threats, specifically smallpox. We are proud to supply our smallpox antiviral treatment to many countries and NGOs, and we remain committed to ensuring that TPOXX is positioned for rapid, large-scale deployment whenever it is needed to help save lives.

The case for preparedness has never been stronger. Smallpox and other high-consequence threats, whether the result of an accident, a deliberate act, or a natural occurrence, represent a real and serious threat that can be managed only with proactive, sustained investment.

Stockpiling medical countermeasures is a cornerstone of preparedness strategies. In today's environment of rising geopolitical tension, accelerating technological risks, including those enabled by AI tools, and growing biological threats, the urgency to make that investment is clear. We believe TPOXX is uniquely suited to meet the smallpox threat with a well-established safety profile and targeted mechanism of action that supports broad use in emergency situations. The first quarter of 2026 reflected a variable rhythm inherent to our business.

Activity levels vary quarter to quarter. The first quarter had minimal product deliveries, whereas in the second quarter, we expect to deliver approximately $13 million of oral TPOXX to an international customer, as well as make additional IV TPOXX deliveries to the SNS. As a reminder, given this quarter-to-quarter variability, we recommend that our results be viewed in the context of our longer-term performance rather than in isolation.

We believe our long-term outlook continues to offer substantial opportunities. This belief is grounded in the fundamentals of our business and the enduring need for governments to protect against biological threats. We continue to maintain engagement with the U.S. government, particularly key stakeholders at HHS. Although the pace of progress toward a new contract with the U.S. government has been slower than prior contract processes, we believe the $27 million in funding secured in 2025 to support pediatric formulation development and IV TPOXX technology transfer efforts, as well as the 2025 IV TPOXX order are strong signals highlighting the continued role of TPOXX is expected to play in the U.S. biothreat preparedness. It's worth reiterating that the SIGA's operating model is closely aligned with the U.S. government priorities.

Specifically, the U.S. government receives our lowest price of oral TPOXX and our active pharmaceutical ingredient and all finished drug products is manufactured domestically. Turning to our international business, we continue to engage with governments and other key stakeholders around the world who continue to review their preparedness strategies and funding. Strategic stockpiling remains central to those conversations. Government procurement is a deliberate process. That said, discussions continue, and we see potential for additional international sales over time. As noted last quarter and earlier on this call, we received a $13 million order from a country in the Asia Pacific region, which we expect to deliver in the second quarter of this year. We also took important steps towards potential sales in a region where SIGA has historically been underrepresented.

We recently entered into an exclusive license and distribution agreement with Hikma MENA FZE that gives Hikma the right to register and commercialize TPOXX across the Middle East, North Africa or MENA. Under the agreement, SIGA will serve as an exclusive manufacturer and supplier of finished product for Hikma. This agreement represents a key step in our strategy to broaden global access to TPOXX. Hikma is the right partner for it. Their unparalleled regional presence and deep expertise in bringing innovative medicines to market make Hikma well-positioned to bring TPOXX to these markets. Turning to our pipeline, we continue to advance our post-exposure prophylaxis or PEP and pediatric programs. On the pediatric program, we filed our IND and initiated a phase I study. Results are expected in the second half of this year, which will inform next steps.

On the PEP program, the CDC continues its work on analysis of immunogenicity samples. We are targeting an FDA submission for PEP indication in the next 12 months. Looking forward, we remain focused on what has always driven this business, financial and operational discipline, and building on the partnership that positions SIGA for long-term success. As we move further into 2026, we do so with a clear sense of purpose. The global need for biological preparedness is real and growing, and SIGA is prepared to meet it. We have a product approved by regulators around the world, strong government relationships, and a team that executes. We look forward to continued progress and to updating you along the way. With that, I'll turn it over to Dan to review the financial results in more detail. Dan?

Thanks, Diem. As noted earlier in the call, the company had minimal product deliveries in the first quarter, reflecting the variable rhythm of SIGA's business model. Product revenues for this quarter include approximately $1 million of IV TPOXX deliveries to the SNS and approximately $2 million of reimbursement revenues in connection with the manufacturing technology transfer. In addition to product-related revenues in the first quarter, the company also had research and development revenues of approximately $3 million. As I talk about revenues, I would like to highlight that we expect second quarter product revenues to reflect the delivery of approximately $13 million of oral TPOXX to an international customer, as well as additional IV TPOXX deliveries to the SNS.

Returning to the first quarter financial results, pre-tax operating loss for the quarter, which excludes interest income and taxes, was approximately $5 million, and net loss for this period was approximately $3 million. In turn, fully diluted loss per share for the three months ended March 31st, 2026 was $0.05. The company continues to maintain a strong balance sheet. As of March 31st, 2026, the company had a cash balance of approximately $146 million and no debt. Based on the company's substantial cash balance, a special cash dividend of $0.60 per share was declared on March 26 for shareholders of record as of April 7. The special cash dividend was paid on April 23rd. This concludes the financial update. At this point, I'll turn the call back to Diem.

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. Your first question comes from Jyoti with Edison Group. Please go ahead.

Hi. Good afternoon, and thanks for taking my questions. My first question is related to CHMP's recent recommendation that TPOXX should not be used for mpox treatment. Now this was largely expected, and you had also guided for this previously. Do you see any impact of this decision on TPOXX broader labeling in smallpox and other orthopoxviruses in Europe?

Jyoti, thank you so much for asking the question. Just for a reminder for those that are on the call, we had shared earlier that the CHMP has confirmed the positive benefit risk balance of Tecovirimat SIGA, which is known as TPOXX in Europe as a treatment for smallpox, cowpox, and vaccinia complications. Those indications have been reaffirmed by CHMP. As you mentioned, the CHMP had recommended to the European Commission to withdraw the mpox indication. We are currently taking the necessary regulatory steps to inform all relevant stakeholders as well as implement the CHMP recommendation following its adoption by the European Commission. Having said all that, by the way of this background, TPOXX was developed as a treatment for smallpox to save lives and to serve as a critical countermeasure against smallpox.

Smallpox is one of the world's most dangerous biothreats, and this antiviral is needed for the event of an outbreak. In contrast, the mpox trials measure Tecovirimat's benefit using complete lesion resolution, an endpoint related to the immune activity in patients already progressing towards self-resolution. Saving lives of patients suffering from smallpox has been and will continue to be SIGA's focus.

Thank you. This is quite helpful. My next question is related to the dividend payout. You recently paid out the fifth consecutive annual special dividend. This is a sign of a strong balance sheet, but how comfortable are you returning this level of capital while maintaining sufficient liquidity through the potential gaps in government ordering, and particularly given that the revenues tend to be lumpy?

Hi, Jyoti, this is Dan. Maybe as a starting point, just to point out that the 2026 dividend as well as prior dividends, they were declared or have been declared and paid with the understanding that we do have a business model that is subject to variability. This variability has been a consistent feature of SIGA's business model. It's not really a new thing. We have been navigating this over the years. When assessing a potential dividend in 2026, we considered many factors, including our continuing focus on deploying capital to drive the greatest value for shareholders, as well as our substantial cash balance, which at March 31st was approximately $146 million.

When you take into account the dividend on a pro forma basis, the cash balance would still be over $100 million and with no debt. When you take all these things into account, as well as multiple other considerations, the company believes that, you know, we continue to be well-positioned to navigate any near-term gaps in government ordering.

That's great, Dan. And you mentioned that your cash position remains strong even after the dividend payout. Now, if we look ahead, what would be your key priorities for capital deployment? We've asked this previously, but are you actively considering acquisitions or in-licensing opportunities?

Yes. As you mentioned, it has been a discussion point in the past, and the answer is yes. We continue to explore ways to expand the pipeline, either through acquisition or in-licensing. You mentioned we talked about this before and in prior calls, we have highlighted that we remain committed to deploying capital in ways that we believe will drive the greatest value. That could be through dividends, that could be through acquisitions, it could be through in-licensing, or it could be through other means.

Thank you. That's very helpful. I have one final question. This relates to international markets. You've announced a large, $13 million order from the Asia Pacific, which will be delivered in Q2. You also announced the recent licensing agreement with Hikma for the MENA region. Are you seeing a broader increase in stockpiling interest across all international markets, or is it restricted to any particular geographies? Just following on from that, on the Hikma agreement, can you provide a bit more color on the deal economics? If it is structured similarly to your previous partnership with Meridian?

Yes, yeah. Jyoti, I can take that answer. As we mentioned earlier in the call, we do expect to deliver approximately 13 million oral TPOXX to an international customer in the second quarter. We remain engaged and active with other potential customers and will provide updates as additional orders occur in this region as well as others. It's not specific to a target region. In addition, just with our conversations with Hikma, we're quite enthusiastic and excited about the opportunity as we believe Hikma can help unlock any demand across the MENA region, which was underrepresented for SIGA before. As noted in our prepared remarks, Their strong regional presence and deep expertise navigating complex procurement processes make them a highly strategic and attractive partner to bring TPOXX to these markets.

In short, from a deal construct perspective, we will supply finished product to Hikma, who manages the customer relationships in the region. TPOXX will be sold at a price set forth in the agreement. SIGA may also be entitled to additional payments under certain conditions. These financial terms of the agreement are confidential, so no, not further disclosed.

Thank you. This is very helpful. Thank you so much. No further questions from my side.

There are no further questions at this time. I will turn the call back over to Diem Nguyen.

Thank you. I'd like to thank everyone making the time to join us on today's call and for your ongoing interest in SIGA. We look forward to speaking to you again in our second quarter call. Have a great evening.

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

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 from the forward-looking statements. SIGA 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 31st, 2025, and its subsequent reports on Form 10-Q and Form 8-K. With that, I will turn the call over to Diem Nguyen, Chief Executive Officer of SIGA. Diem?

Good afternoon, everyone, and thank you for joining today's call and review of our business results. I'm joined by Dan Luckshire, our Chief Financial Officer, and we appreciate this opportunity to provide an update on our company. After the update, we'll be happy to answer your questions. Coming out of 2025, SIGA remains focused on supporting governments around the globe to advance long-term preparedness strategies for potential biological threats, specifically smallpox, whether accidental, intentional, or naturally occurring. Our efforts are centered on continuing to serve as a leading provider of smallpox antiviral treatment to more than 30 countries and NGOs across the world and helping ensure that antiviral treatments can be rapidly deployed at scale to protect and save lives should an outbreak occur. Preparedness for high-consequence threats like smallpox requires advanced planning, sustained investment, and ready access to medical countermeasures, primarily through stockpiling.

In a time marked by heightened geopolitical risks, rapid technological change, and increased biological threats, readiness is more important than ever. TPOXX's established safety profile and targeted mechanism of action make it particularly well-suited for use in emergency situations requiring broad distribution. From a financial perspective, SIGA delivered solid financial results for 2025. The fourth quarter, like prior quarters, should be viewed in the context of full year and longer-term performance rather than as a standalone period, as some quarters are quieter than others, given the unique nature of our business model. 2025 product revenues totaled approximately $88 million. This includes $53 million of oral TPOXX and $26 million of IV TPOXX delivered under the current BARDA 19C contract to the U.S. Strategic National Stockpile, as well as $6 million from international oral TPOXX sales.

At the end of the year, approximately $26 million of U.S. government orders are outstanding related to the March 2025 IV TPOXX procurement order, which we continue to expect to deliver in 2026. With our current BARDA contract nearing completion, engagement with the U.S. government, including key stakeholders at HHS and ASPR, remains active and constructive. As a reminder, during 2025, SIGA secured $27 million in funding to support pediatric formulation development and IV technology transfer efforts. In our view, this funding reinforces the role TPOXX is expected to play in biothreat preparedness. Against this backdrop, we remain prepared to move forward when the U.S. government is ready to proceed. A new procurement contract with the U.S. government would be a continuation of a stockpiling relationship that has been productive for more than a decade and would represent another milestone for our relationship with the U.S. government.

I would also like to reinforce an important aspect of our operating model. SIGA's pricing and manufacturing approach has been long aligned with the U.S. government priorities. As our largest customer and partner in developing TPOXX, the U.S. government has always received our lowest price for TPOXX. Additionally, all active pharmaceutical ingredients and finished drug products are manufactured domestically. Internationally, we continue to engage with governments and stakeholders focused on strengthening health security. As biothreat risks increase, many countries are reassessing their preparedness strategies and expanding defense budgets. Strategic stockpiling remains foundational to preparedness. We continue to discuss stockpiling of TPOXX with various potential customers across the globe and recently received a $13 million order from a country in the Asia-Pacific region. Turning to Europe, I'd like to address the EMA referral procedure for TPOXX, known as Tecovirimat SIGA in Europe, initiated last July.

As previously discussed, the referral was precipitated by the results from the mpox clinical trials PALM 007 and STOMP. Over the past seven months, we have gone through two rounds of questions and answers as well as EMA scientific advisory group meetings and have provided thorough science-based responses to the EMA. The EMA's Committee for Medicinal Products for Human Use, or CHMP, is expected to meet in March to issue its recommendation to the European Commission regarding the product's marketing authorization. We expect the CHMP to confirm the positive benefit-risk balance of Tecovirimat SIGA as a treatment for smallpox, cowpox, vaccinia complications, and maintain those indications in our product label.

Regarding mpox, based on the results of the mpox clinical trials, we expect the CHMP to recommend withdrawal of the mpox indication. To provide some additional context, TPOXX was developed to reduce mortality and lesion disfigurement and related issues from smallpox by stopping viral dissemination. This distinction is important when evaluating the recent mpox trial data, where the vast majority of the patients in those trials were treated well past peak viral load and were already progressing towards self-resolution. Speed of treatment is critical, which is why TPOXX continues to represent a strategically critical asset for national and international stockpiles. In addition to smallpox treatment, efforts within our late-stage pipeline continue to focus on the post-exposure prophylaxis program. Our collaboration with the CDC remains ongoing, with analysis of immunogenicity samples underway. We're currently targeting an FDA submission of the PEP indication in the next 12 months.

In partnership with BARDA, we continue to advance our pediatric program to develop an oral suspension formulation for children who are unable to use oral capsule formulations. Notably, we have recently filed our IND and initiated a phase I study. Results are expected in the second half of this year. As we look ahead, our priorities remain consistent, maintaining financial strength, executing with discipline, and advancing strategic initiatives that support long-term value creation. In closing, SIGA entered 2026 from a position of strength defined by strategic focus, financial discipline, and durable government partnerships. Our differentiated TPOXX franchise and proven execution position us well to support global health security while continuing to deliver long-term value for shareholders. With that, I'll turn it over to Dan to review the financial results in more detail. Dan?

Thanks, Diem. As noted earlier in the call, SIGA continued to advance its long-term priorities in 2025. This includes securing $27 million in additional U.S. government funding to support development and manufacturing activities, as well as generating $88 million of product revenues and $24 million of pretax operating income. Product revenues of $88 million are primarily driven by product deliveries to the SNS under the 19C BARDA contract. Product deliveries to the SNS in 2025 include $53 million of oral TPOXX and $26 million of IV TPOXX sales. In addition to product sales to the U.S. government, 2025 product revenues also include $6 million of oral TPOXX sales to an international customer. In addition to product revenues, the company also has research and development revenues of approximately $7 million for 2025.

As a supplemental note, there are $26 million of outstanding U.S. government orders as of December 31st, 2025. This amount reflects the $26 million IV TPOXX order received in the first quarter of 2025, which continues to be targeted for delivery in 2026. Pretax operating income in 2025, which excludes interest income and taxes, is approximately $24 million. After taking into account interest income and taxes, net income for 2025 is approximately $23 million. In turn, fully diluted income per share for 2025 is $0.32 per share. The company continues to maintain a strong balance sheet. At December 31st, 2025, the company had a cash balance of approximately $155 million and no debt. This concludes the financial update. At this point, I will turn the call back to Diem.

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 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 star followed by the number two. If you're using a speakerphone, please lift the handset before pressing any keys. Once again, it is star one if you wish to ask a question. Our first question comes from the line of Jyoti Prakash from Edison Group. Your line is now open.

Hi. Good evening, and thank you for taking my question. Starting off with the U.S. RFP, BARDA recently issued a sources sought notice for smallpox vaccines, which strongly suggests preparedness remains a priority for the government. Now, based on your ongoing discussions with the authorities, do you have any updated visibility on the timing of the next U.S. government RFP for TPOXX?

Thanks, Jyoti, for that question. As you mentioned, this sources sought notice as well as the U.S. government actions over the past 12 months suggest that smallpox preparedness remains an important focus for the U.S. In addition to the activity you mentioned, the government took the delivery of approximately $79 million of TPOXX in 2025 and exercised a procurement option for roughly $26 million in IV TPOXX and committed to an additional $27 million for development funding. In terms of timing, we don't have any additional details to share today. What we can say based on our ongoing interactions is that smallpox preparedness continues to be a focus area within the government. That we remain engaged and continue to have productive conversations with relevant officials across the government, including HHS as well as ASPR leadership.

Based on those discussions, we continue to believe that TPOXX remains an important component for the U.S. preparedness strategy.

That's great. Thank you for that. My next question relates to the capital allocation. Figures ended the year with a strong cash position. You mentioned $155 million in cash and no debt on the books. How should we think about your capital allocation priorities looking ahead? Can we expect continued special dividends as we've seen two-three years, or could you take a different approach looking forward?

Hi, Jyoti. This is Dan. On this question, as a starting point is, as a general matter, capital management strategy, we plan to remain disciplined and flexible, and we try to do our capital management activities with the goal of supporting long-term value creation for our shareholders. You had a specific question on the special cash dividend. Regarding the special cash dividend, the timing of this question is a little early. Just for your reference, in prior years, we've usually addressed this topic in the March to May timeframe. Right now we're kind of in the early stages of this historical timeframe, so we don't have anything further to say right now. I would say that please stay tuned for more information between now and May.

That's great. Just if I can follow up on the question, are you also open to acquisitions or in-licensing opportunities to broaden the pipeline?

Jyoti, yes. The short answer is yes. We continue to have the capability to pursue these types of opportunities. Our approach to M&A as well as investments will always remain disciplined and strategic. Our focus remains on creating shareholder value while doing what's best for patients, health, security and other stakeholders, and we approach that thoughtfully.

Thank you. I just have one last question from my side and this relates to international orders. It was great to see a strong start to 2026 with the recent $13 million TPOXX order. You mentioned that this is a multi-year contract. Are we right in assuming that this relates to the same customer that placed the $11 million order in late 2024? Following from that, could you provide a bit more color on the contract duration, the potential order frequency and the size of the contract? Finally, can we expect additional international orders through the year?

All right. Thanks. I think there's a few questions within there. Just maybe the starting point, the $13 million order in the Asia-Pacific region, just wanna highlight that we do believe that reflects the progress we've been making in strengthening relationship with government partners around the world. We believe that the partners continue to focus on enhancing preparedness for potential smallpox outbreaks, and we believe the $13 million order reflects that. I believe you had a question as to the details of that order. Consistent with a lot of orders on the international front, for security reasons, most of our customers, government customers don't allow us really to disclose many specifics.

In terms of the details, what we can share is that, as we mentioned, it does come from a repeat customer. However, it's not the customer you're referring to from 2024, but it is a repeat customer. It is a multi-year contract. The multi-year contract feature gives them the flexibility to place additional orders at their discretion. The discretion is both in terms of size as well as timing. I think there's one part, this you know, I guess the second part of your question is, well, you know, additional sales, you know, in terms of what we're looking for in addition to this order.

Yes.

While additional international sales may occur in 2026, we really do wanna continually highlight that these discussions are usually complex and these processes can take time to move through. We'll continue to move forward and when we have something to announce, we'll let you know. I do wanna highlight that we do remain actively engaged with a range of international customers.

Thank you. This is very helpful. No further questions from my side.

As a reminder, if you have any questions or follow-up, please press star one. There are no further questions at this time. I will now turn the call over back to Diem Nguyen, Chief Executive Officer. Please continue.

Thank you, John. I'd like to thank everyone here for making the time to join us on today's call and as always, for your ongoing interest in SIGA. We look forward to speaking to you again on our first quarter call. Have a great evening.

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