SIGA TECHNOLOGIES INC Q3 FY2025 earnings call

• Progress across key initiatives aligned with supporting governments in preparedness for smallpox outbreaks.
• TPOXX's strong safety profile makes it ideal for mass distribution under emergency conditions.
• Financial performance over 9 months and Q3, including revenue details and pre-tax income/loss figures.
• Engagement with U.S. government regarding future TPOXX development, manufacturing, and procurement.
• Submission of comprehensive responses to EMA's questions about TPOXX's efficacy in treating mpox, with CHMP meeting next week.
• Pipeline updates: TPOXX post-exposure prophylaxis program collaboration with CDC, targeting FDA submission in 2026; pediatric program progress with BARDA.
• Strong balance sheet with $172 million cash and no debt.

For the 9 months ended September 30, 2025, product revenue totaled approximately $86 million. This included $53 million of oral TPOXX and $26 million of IV TPOXX sales under the 19C BARDA contract, as well as $6 million of oral TPOXX sales to an international customer. As of the end of the third quarter, there was approximately $26 million of outstanding orders remaining from the U.S. government, relating to a March 2025 order of IV TPOXX expected to be delivered in 2026. Product revenue for the 9 months outpaced the comparable period last year which was $54 million. Research and development revenues for the 9 months ended September 30, 2025, were approximately $5 million. Pre-tax operating income for the 9 months was approximately $33 million, while net income was approximately $29 million with fully diluted income per share of $0.40 per share. For the 3 months ended September 30, 2025, product revenue was $0.9 million, pre-tax operating loss was approximately $10 million, net loss was approximately $6 million, and net loss per share was $0.09. The company had a cash balance of approximately $172 million and no debt as of September 30, 2025.

• Expect multiple international sales in 2026.
• Target FDA submission for the PEP indication in 2026.
• Continued engagement with U.S. government regarding TPOXX procurement, encouraged by their continued interest in TPOXX as a critical medical countermeasure for smallpox.

• Potential delays in CDC completing analysis of samples for the PEP program due to government shutdown timelines.
• Impact on activities with government employees outside BARDA, though not materially impacting operations to date.

Q: 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?

A: Sure, Jyoti. It's nice to hear from you. We are fortunate at this time that the headcount reductions at the world's furloughs has 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 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 operational -- 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 trial supporting our PEP program. 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 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. And this includes ASPR, HHS, DoD as well as Administration as well as Congress over the long term. And 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.

Q: And 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 products revenue. Can you elaborate on what these revenues came from? And are they related to the CD&D, for instance? And secondly, we saw that the cost of goods as a percentage of sales was relatively higher in this quarter versus what we've seen in the previous quarters. Can you just explain what could be the reasons for this?

A: This is Dan. I'll take that question. You're right in that. You mentioned that we have a strong cash position. And just to reiterate, it's $172 million at September 30, and there's no debt. So, 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. So, that affords us a lot of flexibility. And so, 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 we'll continue to be adaptive with an eye toward finding the best mix of pursuing opportunities and managing risks. Right, right. So, in a quiet quarter like this, you do -- then you sort of have, sort of, some technical outcomes that don't necessarily reflect any type of trend. What you're seeing on the revenue side is really the way the accounting works is certain -- in limited circumstances and certain types of reimbursement activities are treated as product revenues, and that really ties into the -- for example, the IV tech transfer. So that's what you see on the product revenue side. And then, 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. But there is a small amount percentage-wise that's attributable to, sort of, semi-fixed costs, such costs or expenses such as stability, storage, security. And even when we don't -- it's a quiet quarter, we don't really have much in the way of product deliveries. We still have those expenses show up each quarter. So that's what you also see coming through the cost of goods sold. So 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. But again, I would highlight that this is more of a technical outcome and that it does not reflect any type of trend.