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SIGA Technologies Inc.
3/10/2026
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 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, Executive Officer of SIGA, ZEM.
Good afternoon, everyone, and thank you for joining today's call and review of our business results.
I'm 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 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 risk, rapid technological change, and increased biological threats, readiness is more important than ever. TPOC's established safety profile and targeted mechanisms 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 TPOCs and $26 million of IV TPOCs delivered under the current Barter 19-Z contract to the U.S. Strategic National Stockpile, as well as $6 million from international oral TPOC sales. At the end of the year, approximately $26 million of U.S. government orders are outstanding related to the March 2025 IV TPOCs 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, SEGA secured $27 million in funding to support pediatric formulation development and IV technology transfer efforts. In our view, this funding reinforces the role TPOC 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. DIGA's pricing and manufacturing approach has been long aligned with the U.S. government priorities. As our largest customer and partner in developing teapots, the U.S. government has always received our lowest price for teapots. 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 TPOCs 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 TPOCs, known as Ticovira-Matsuga in Europe. initiated last July. As previously discussed, the referral was precipitated by the results from the MPOCS clinical trials, POM007, and STOM. 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 ticavir-matsiga as a treatment for smallpox, cowpox, vasemia complications, and maintain those indications in our product labels. 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, TPOX was developed to reduce mortality and lesion disfiguration 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 we're 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 formulation. Notably, we 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 priority is swimming consistently. maintaining financial strength, executing with discipline, and advancing strategic initiatives that support long-term value creation. In closing, Stiga entered 2026 from a position of strength, defined by strategic focus, financial discipline, and durable government partnerships. Our differentiated TPOC 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?
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