Siga Technologies Q3 2025 Earnings Report

Siga Technologies EPS Results

• Actual EPS: -$0.09
• Consensus EPS: N/A
• Beat/Miss: N/A
• One Year Ago EPS: N/A

Siga Technologies Revenue Results

• Actual Revenue: $2.62 million
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Siga Technologies Announcement Details

• Quarter: Q3 2025
• Date: 11/6/2025
• Time: After Market Closes
• Conference Call Date: Thursday, November 6, 2025
• Conference Call Time: 4:30PM ET

Siga Technologies (NASDAQ:SIGA), Inc. is a commercial-stage pharmaceutical company focused on developing and supplying medical countermeasures for biological threats and emerging infectious diseases. The company’s principal product is TPOXX (tecovirimat), an antiviral treatment developed for smallpox. TPOXX is available in oral and intravenous formulations, with regulatory approvals supporting its use in the United States and certain international markets.

SIGA primarily serves government agencies, including the U.S. government, which has procured TPOXX for the Strategic National Stockpile and other public-health preparedness programs. The company also works with international governments and public-health organizations to support smallpox preparedness and response. In addition to government procurement, TPOXX may be made available for certain patients under applicable emergency-use or public-health protocols.

SIGA has historically focused its research and development activities on antiviral drugs and biodefense products. The company is headquartered in New York City and became a publicly traded company through its merger with PharmAthene in 2015. Phillip L. Gomez serves as chief executive officer. SIGA continues to concentrate on the development, regulatory support and supply of TPOXX and related medical countermeasures.

Siga Technologies Q3 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: YTD product revenue of ~$86 million, including $53M oral and $26M IV under the 19C BARDA contract, with approximately $26M of IV orders outstanding targeted for delivery in 2026 to the U.S. Strategic National Stockpile.
• Positive Sentiment: Strong balance sheet with approximately $172M cash, no debt, cash greater than four times annual operating expenses, and about $230M returned to shareholders since 2020 via dividends and buybacks.
• Neutral Sentiment: Pipeline progress — SIGA is targeting a 2026 FDA submission for the TPOXX post‑exposure prophylaxis (PEP) indication and plans a pediatric IND by year‑end with ~$27M awarded for pediatric and IV tech transfer work, though CDC sample analysis and government shutdowns could delay timelines.
• Negative Sentiment: Regulatory uncertainty in Europe as the EMA initiated a referral on Tecovirimat SIGA (mpox efficacy) and the CHMP meets next week to either issue an opinion or request additional data, which could affect EU positioning and potential sales.

Presentation

[Operator]

Welcome to the SIGA Business Update call. Before we turn the call over to SIGA Management, please note that any forward-looking statements made during this call are based on management's current expectations and observations, and are subject to risks and uncertainties that could cause actual 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 change 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, 2024, 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.

[Diem Nguyen, CEO at SIGA Technologies]

Good afternoon, everyone, and thank you for joining today's call and review of our business results for the third quarter of 2025. 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. With nine months of the year behind us, we've continued to make progress across several key initiatives, aligned with our mission to support governments in building and maintaining robust preparedness plans in the event of a potential smallpox outbreak, whether accidental, deliberate, or naturally occurring. Our work is focused on helping to ensure that, in an event of such a crisis, rapid and large-scale deployment of antiviral treatments can be accomplished to save lives. Having preparedness strategies, particularly for Category A threats like smallpox, with provisions for stockpiling medical countermeasures can enable immediate action.

[Diem Nguyen, CEO at SIGA Technologies]

In today's dynamic and increasingly complex global landscape, bioterrorism continues to be a significant concern, underscoring the importance of proactive preparedness. TPOXX's strong safety profile makes it an ideal choice for mass distribution under emergency conditions. The third quarter was relatively quiet as SIGA's financial strength was demonstrated in our strong second quarter performance, which included $79 million in product revenues. These quarterly fluctuations are consistent with the nature of SIGA's business model, where our financial performance should be assessed beyond quarters. For the nine months ended September 30, 2025, product revenue totaled approximately $86 million, including $53 million of oral TPOXX and $26 million of IV TPOXX sales under the 19C BARDA contract, with the delivery to U.S. Strategic National Stockpile, or SNS, and the $6 million of oral TPOXX sales to the international customer.

[Diem Nguyen, CEO at SIGA Technologies]

As of the end of the third quarter, there was approximately $26 million of outstanding orders remaining from the U.S. government. This outstanding balance relates to the March 2025 U.S. government order of IV TPOXX, which we expect to deliver in 2026. Importantly, we continue to be engaged with the U.S. government regarding future TPOXX development, manufacturing, and procurement. As a reminder, year to date, SIGA has been awarded $27 million for pediatric formulation development and IV tech transfer activities. Since September, SIGA has been actively engaged with the U.S. government regarding the future procurement of TPOXX. While the details of our conversation with government officials remain confidential, we're encouraged by their continued interest in maintaining access to TPOXX as a critical medical countermeasure for smallpox, particularly amidst the disruption and uncertainty of the ongoing government shutdown.

[Diem Nguyen, CEO at SIGA Technologies]

Antivirals remain essential for bioterrorism preparedness and play a vital role in any comprehensive plan, enabling quick action when it matters most. I'd also like to highlight an additional point of interest. Our approach to pricing and manufacturing has historically been well aligned with the administration's priorities. The U.S. government has always received our lowest price for TPOXX compared to international purchasers. All of our active pharmaceutical ingredients, or API, and finished drug products are produced in facilities located in the U.S. On the international side of our business, we continue to have discussions with key stakeholders on the critical role biodefense plays in shaping resilient global health security frameworks. Our goal is to help ensure that countries around the world are equipped to respond swiftly should a smallpox outbreak occur.

[Diem Nguyen, CEO at SIGA Technologies]

Given the growing risks of bioterrorism, many countries and regions have developed preparedness strategies and have allocated larger budgets to executing those strategies, while others are working to do so. In our view, strategic stockpiling, supported by sustained investment in crisis preparedness, is critical to global health security. Discussions around potential contracts with both existing as well as new customers are ongoing as we maintain current relationships and look to expand our customer base. Based on our engagements this year and interest from key stakeholders across strategic markets, we expect multiple international sales in 2026. I'd also like to share a brief update on the referral procedure for TPOXX, known as Tecovirimat SIGA in Europe, commenced by the European Medicines Agency, or EMA, in July.

[Diem Nguyen, CEO at SIGA Technologies]

As we previously explained, the EMA raised questions about our product's efficacy in treating Mpox following a review of the data from Mpox clinical trials, including POM 007 and STOMP. We have submitted comprehensive science-based responses to questions posed by the EMA, which were focused primarily on Mpox. The EMA's Committee for Medicinal Products for Human Use, or CHMP, will meet next week, and we expect it will either issue an opinion or request for additional information. While we will not speculate on what the CHMP will do, we are confident in the responses we put forth and believe TPOXX is a safe and effective drug for its approved indications. We remain ready to address any additional questions and provide greater clarity as needed from the CHMP.

[Diem Nguyen, CEO at SIGA Technologies]

As always, we encourage stakeholders to view TPOXX through the lens of the comprehensive data and gravity of the disease it's designed to treat, namely smallpox. As a reminder, TPOXX is highly targeted and was developed as a smallpox treatment with the goal of reducing mortality. In preclinical trials, TPOXX significantly reduced mortality and viral load across four pivotal studies in non-human primates and two in rabbits. Safety has been demonstrated in about 10,000 TPOXX recipients across more than 20 clinical trials, which is critical when we need it for mass distribution. Turning to our late-stage pipeline, we continue to advance the TPOXX post-exposure prophylaxis program, or PEP, for smallpox. Collaboration with CDC continues. As a reminder, the CDC is analyzing samples collected to support the study's immunogenicity objective.

[Diem Nguyen, CEO at SIGA Technologies]

Based on TPOXX's mechanism of action, we believe TPOXX will not have any impact to JYNNEOS immune response when administered concomitantly with JYNNEOS. Therefore, we continue to move forward toward an FDA submission. While the government shutdown does impact near-term timelines for this project, based on current expectations, we continue to target the FDA submission for the PEP indication in 2026. Also, in our pipeline, our pediatric program continues to move forward in partnership with the Biomedical Advanced Research and Development Authority, or BARDA, within the U.S. Department of Health and Human Services under the Administration for Strategic Preparedness and Response, or ASPR. This initiative is designed to address an important unmet need, providing a treatment option for children too small for the current oral formulation of TPOXX.

[Diem Nguyen, CEO at SIGA Technologies]

We're targeting to submit an IND as soon as the end of the year, with phase one trials targeted to begin shortly thereafter. As we approach year-end, our key priorities remain unchanged: sustaining financial strength and executing our strategic initiatives with discipline and focus. Despite the expected lumpiness of our financial results quarter-to-quarter, our company continues its track record of generating substantial cash flow. Since 2020, we've returned approximately $230 million to shareholders in the form of dividends and share buybacks, all while incurring zero debt. We believe our approach continues to position us well for long-term success, where our core areas of focus have delivered meaningful long-term value for our shareholders. In closing, we believe SIGA continues to build on its strong foundation of strategic focus, financial discipline, and strength in long-term government partnerships.

[Diem Nguyen, CEO at SIGA Technologies]

Our differentiated TPOXX franchise and history of performance reinforce our path forward, one that supports global health security and creates long-term shareholder value. With that, I'll turn over to Dan to review the financial results in more detail. Dan.

[Dan Luckshire, CFO at SIGA Technologies]

Thanks, Diem. As noted earlier in the call. SIGA's product sales for the nine months ended September 30, 2025, are approximately $86 million. Including $53 million of oral TPOXX and $26 million of IV TPOXX sales under the 19C BARDA contract, and $6 million of oral TPOXX sales to an international customer. The sales under the 19C BARDA contract relate to TPOXX deliveries to the U.S. Strategic National Stockpile, or SNS. Product sales for this time period outpaced sales over the comparable period last year of $54 million. In addition to product sales, the company has research and development revenues of approximately $5 million. For the nine months ended September 30, 2025. With respect to the three months ended September 30, 2025. As Diem mentioned, it was a relatively quiet quarter, which follows a strong second quarter in which the company had $79 million of product revenues.

[Dan Luckshire, CFO at SIGA Technologies]

As previously noted, given the nature of the business model of SIGA, fluctuations in revenue amounts between quarters are not unusual. As a supplemental note, there are $26 million of remaining outstanding orders as of September 30. This amount reflects the $26 million of IV TPOXX orders received in the first quarter of this year under the 19C BARDA contract, which is targeted for delivery in 2026. Pre-tax operating income for the nine months ended September 30, 2025, which excludes interest income and taxes, is approximately $33 million. For the three months ended September 30, 2025, pre-tax operating loss is approximately $10 million. Net income for the nine months ended September 30, 2025, is approximately $29 million. In turn, fully diluted income per share for this period is $0.40 per share. For the three months ended September 30, 2025, net loss is approximately $6 million.

[Dan Luckshire, CFO at SIGA Technologies]

Net loss per share is $0.09. The company continues to maintain a strong balance sheet. At September 30, 2025, the company had a cash balance of approximately $172 million and no debt. This concludes the financial update. At this point, I will turn the call back to Diem.

[Diem Nguyen, CEO at SIGA Technologies]

Thank you, Dan. With that, we'd like to open the call up for questions.

[Operator]

Ladies and gentlemen, should you have a question, please press star followed by one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to remove your hand from the queue, please press star followed by two. If you're using a speakerphone, please lift the handset before pressing any keys. Just a moment for your first question. Your first question comes from Jyoti Prakash at Edison Group. Please go ahead.

[Jyoti Prakash, Analyst at Edison Group]

Hi. Good evening and thank you for taking my questions. My first question is related to the U.S. RFP process for TPOXX. You mentioned disruptions with the U.S. government and the recent shutdowns. What kind of potential impact, if any, do you see on the ongoing RFP process and the timelines for TPOXX stockpiling?

[Diem Nguyen, CEO at SIGA Technologies]

Jyoti, thanks. Nice to hear from you. We are fortunate at this time that the headcount reductions as well as furloughs have not materially impacted operational activities or performance of our existing government contracts. Many of the people we work with continue to engage, given the nature of what they do, as well as the importance of national security. There are some instances in which activities with the government employees outside BARDA have been impacted. In these cases, the impact has not been material to our operations to date. The one area that we would like to highlight that we do see some impact is with the CDC. There is a possibility of delays in the CDC completing the analysis of our samples from the trials supporting our PEP program.

[Diem Nguyen, CEO at SIGA Technologies]

The CDC was originally targeting to complete analysis later this year, and that could potentially slip given the timelines of the government shutdown. I mean, regarding the new procurement contract for TPOXX, as we noted in our prepared remarks, we continue to engage with the government officials regarding TPOXX's development, manufacturing, and procurement. While the headcount reductions for furloughs do expose contractors to some potential delays and occasional choppiness in terms of customary interactions, we believe the key drivers of the procurement activity will be ultimately driven by the views and actions of leadership within the U.S. government. This includes ASPR, HHS, DOD, as well as administration, as well as Congress over the long term. I mean, we are encouraged by their continued interest in maintaining access to TPOXX, as we believe, and they do too, that it's a critical countermeasure for smallpox.

[Jyoti Prakash, Analyst at Edison Group]

Thank you, and to continue to be in active dialogue with the U.S. government. If you just hypothesize that the RFP may be slightly delayed, are there any mitigation strategies or operational steps that SIGA is looking to implement or can implement to secure the longer-term outlook? Obviously, your cash position remains strong, so nearer-term may not be as much of a concern.

[Dan Luckshire, CFO at SIGA Technologies]

Hi, Jyoti. This is Dan. I'll take that question. You're right in that you mentioned that we have a strong cash position. Just to reiterate, it's $172 million at September 30, and there's no debt. We are in a very strong position. Just to give you a frame of reference, that cash balance is more than 4x the current annual rate or annual run rate for operating expenses. That affords us a lot of flexibility. What I would say generally is, given this position, I would just generally say that over the past decade, SIGA has been consistently adapted to different environments and will continue to be adaptive, with an eye toward finding the best mix of pursuing opportunities and managing risks.

[Jyoti Prakash, Analyst at Edison Group]

Thank you for that. I just have another couple of questions on the financials. We appreciate that Q3 was a slightly quieter quarter for the company, but you did record $0.9 million of product revenues. Can you elaborate on what these revenues came from, and are they related to the CD&D, for instance? Secondly, we saw that the cost of goods as a percentage of sales was relatively higher in this quarter versus what we have seen in previous quarters. Can you just explain what could be the reasons for this?

[Dan Luckshire, CFO at SIGA Technologies]

Right, right. In a quiet quarter like this, you sort of have some technical outcomes that do not necessarily reflect any type of trend. What you are seeing on the revenue side is really the way the accounting works. In certain and limited circumstances, certain types of reimbursement activities are treated as product revenues. That really ties into, for example, the IV tech transfer. That is what you see on the product revenue side. On the corresponding cost of goods sold, you see the expenses related to it. What you also see is that a lot of cost of goods, as you would expect, are variable costs related to production costs for inventory. There is a small amount, percentage-wise, that is attributable to sort of semi-fixed costs. Such costs or expenses include stability, storage, and security.

[Dan Luckshire, CFO at SIGA Technologies]

Even when we don't—in a quiet quarter—we don't really have much in the way of product deliveries. We still have those expenses show up each quarter. That's what you also see coming through the cost of goods sold. That's why you sort of see, when you look at it on a margin basis, the margin is very different than what you normally see. Again, I would highlight that this is more of a technical outcome and that it does not reflect any type of trend.

[Jyoti Prakash, Analyst at Edison Group]

Thank you. That's very clear. I don't have any further questions, so thank you for taking all my questions.

[Operator]

Thank you. As a reminder, if you wish to ask a question, please press star one. There are no further questions at this time. I'm pleased to turn the call back over to Diem.

[Diem Nguyen, CEO at SIGA Technologies]

Thanks, Marissa. I'd like to thank everyone for making time to join today's call and for your ongoing interest in SIGA. We look forward to speaking to you again in our fourth quarter call. Have a great evening.

[Operator]

This concludes today's conference call. Thank you so much for your participation. You may now disconnect.

Participants

Analysts

• Diem Nguyen, CEO at SIGA Technologies
• Jyoti Prakash, Analyst at Edison Group
• Dan Luckshire, CFO at SIGA Technologies