SIGA TECHNOLOGIES INC Q2 FY2025 earnings call

• Product revenues in Q2: $79M total, with $53M oral TPOXX and $26M IV TPOXX delivered to SNS, fulfilling 2024 year-end orders and leaving ~$26M outstanding from U.S. government. - BARDA funding: Received $27M incremental development funding, $14M for manufacturing over 2-3 years, $13M for pediatric program. - International regulatory: EMA's CHMP commenced referral procedure for tecovirimat regarding mpox efficacy, need to provide science-based responses. - Pipeline: Advancing TPOXX PEP program for smallpox, targeting FDA submission in 2026; pediatric program moving forward, planning IND submission in H2 2025. - Financials: Strong balance sheet with $182M cash, no debt.

In the second quarter of 2025, product revenues totaled approximately $79 million, comprising $53 million of oral TPOXX and $26 million of IV TPOXX delivered to the U.S. Strategic National Stockpile. For the 6 months ended June 30, 2025, product sales were $85 million. Research and development revenues were approximately $2 million for the 3 months and $3 million for the 6 months ended June 30, 2025. Pretax operating income for the quarter was approximately $46 million, and for the 6 months ended June 30, 2025, it was approximately $43 million. Net income for the quarter and the 6 months ended June 30, 2025, was approximately $35 million, with fully diluted income per share $0.49 per share. The company had a cash balance of approximately $182 million and no debt as of June 30, 2025.

• Remaining outstanding orders: ~$26M IV TPOXX expected to deliver in 2026. - BARDA funding: $13M for pediatric program to fund development up to regulatory filings. - Targeting: FDA submission for TPOXX PEP indication in 2026.

• International growth impacted by CHMP's referral procedure for tecovirimat, requiring thorough responses to agency questions. - Geopolitical instability and stockpile strategies in international markets could affect timing of international orders.

Q: How to deploy $13M BARDA funding for pediatric program and trial design?

A: Jyoti, nice to hear from you, and thanks so much for this question. This is a really important program for SIGA because we believe it is important to be able to develop a formulation to protect a very vulnerable population. BARDA has been very supportive of this program throughout the development process, and this additional funding reemphasizes the importance of tecovirimat to the U.S. government. This investment will fund development activities up to regulatory filings. As it relates to the study design, by the way of the background, in 2023, we initiated and concluded a Phase I study that evaluated an oral suspension formulation prototype in healthy adults for the development of pediatric powder for oral suspension formulation. That study looked at a range of factors with a primary goal to understand how the drug in this formulation behaves in the body after a single dose compared to TPOXX capsule. While we're now preparing for the follow-up trial, which will evaluate a refined formulation designed to deliver tecovirimat dose appropriate for pediatric use, it will be a single-dose crossover study that also examines how different meal types affect absorption. This ensures that children receive a safe and effective dose that mirrors adult exposure levels.

Q: Impact of CHMP data request on international growth?

A: This is Dan. I'll take that question. Maybe as a starting point, the background is that we took over the international promotion and marketing from Meridian last summer. Over the past year, we have been spending considerable time strengthening and building relationships with current and potential customers around the globe. And all this effort has really been centered on expanding our international business and ensuring countries are prepared in case of a smallpox outbreak. As you're aware, there's a lot of preparation and groundwork that's part of the international effort. Given the current geopolitical instability and the stockpile strategies for these individual countries, we do believe that we are building an international business that has significant potential. In terms of timing of future sales activity, we expect international orders to continue to be lumpy. With that context, I would highlight that we have sold $135 million of oral TPOXX to 30 countries since 2020. And we do believe that, that shows the depth and the scope of the international opportunity.

Q: U.S. RFP timelines and order delivery lead time?

A: This is Dan. I'll also respond to that question. I think there's 2 components in there, and it's mostly sort of focused on some of the mechanics. We had some prepared remarks on this. But as you can imagine, it's difficult for us to speculate on the exact timing and form of the U.S. government RFP. What we can say is that we do believe that we have seen recent confirmation of the U.S. government's commitment to biodefense this quarter with the combination of the deliveries of TPOXX, which have been substantial and the 2 commitments for development funding that we've talked about both in our prepared remarks as well as our press release, that development funding adding up to $27 million, which is a meaningful number. With that backdrop, our focus does remain on fostering the strong partnership that we've had for a very long time, really over a decade. And this ongoing partnership plays a vital role in supporting what we believe is national security and public health efforts. And we really think that's valuable. It's worth a lot. So overall, we do believe we're well positioned to engage with the U.S. government on RFP when they are ready. In terms of process, I think there was a part of your question about just sort of timing on process. I would say that there are many variables. But in short, maybe I could just sort of at least use the 2018 process that was -- these are long-dated contracts, and that was the last contract we dealt with the United States government that lasted until recently in terms of orders. In that process, in 2018, there's an RFP that was put out. Now granted, in this situation, the RFP could be both open competition or it could be sole source justification. So a variety of different forms. But in 2018, there's an RFP that was put out. And then after the RFP, we would enter a negotiation process. In 2018, from start to finish in terms of negotiation that took 6 months. Having said that, the time frame could vary in either direction given the administration change. So we would be as efficient as possible. We've gone through many procurement processes. And so we will be very efficient and we are prepared. And we're not aware of any impediments to the negotiation process going much faster than 6 months if the U.S. government desires it.

Q: Status of preclinical monoclonal antibody program?

A: Thank you, Jyoti. This is Diem. I'll take that. First and foremost, I would just begin by saying that we remain quite enthusiastic about the opportunity to expand our pipeline with this portfolio of preclinical fully human monoclonal antibodies, which can be used as a potential treatment for a broad range of orthopoxviruses, both as a therapeutic as well as a prophylactic measure. These monoclonals have demonstrated promise in preclinical models. And we are looking to potentially execute on programs to determine the benefits of using this as a stand-alone treatment or in combination with TPOXX. We're currently working through our process to determine the best path forward for these assets from a development and manufacturing perspective, and we'll keep you apprised with our plans as we progress.