Siga Technologies (NASDAQ:SIGA) reported 2025 results and provided a business update focused on its role in global smallpox preparedness, highlighting product deliveries under its current U.S. government contract, ongoing development programs, and expectations around a European regulatory review for tecovirimat.
2025 performance driven by U.S. Strategic National Stockpile deliveries
Chief Executive Officer Diem Nguyen said the company remains focused on supporting governments and non-governmental organizations in preparedness strategies for potential biological threats, specifically smallpox. Nguyen emphasized that readiness depends on sustained investment and access to medical countermeasures through stockpiling, and said TPOXX’s safety profile and mechanism of action support broad distribution in emergencies.
Management broke out 2025 product revenue as including:
- $53 million of oral TPOXX delivered under the BARDA 19C contract to the U.S. Strategic National Stockpile (SNS)
- $26 million of IV TPOXX delivered under the BARDA 19C contract
- $6 million from international oral TPOXX sales
Outstanding U.S. government orders and contract outlook
Luckshire said that, as of December 31, 2025, the company had $26 million of outstanding U.S. government orders tied to an IV TPOXX procurement order received in the first quarter of 2025. Management said it continues to expect that amount to be delivered in 2026.
With the current BARDA contract nearing completion, Nguyen said engagement with U.S. government stakeholders remains “active and constructive,” including interactions with HHS and ASPR leadership. During the Q&A, management was asked about visibility into the timing of the next U.S. government request for proposal (RFP) for TPOXX. Nguyen said the company had no additional timing details to share, but pointed to recent government actions as evidence that preparedness remains a focus, including taking delivery of approximately $79 million of TPOXX in 2025, exercising a procurement option for roughly $66 million in IV TPOXX, and committing $27 million in development funding.
Nguyen also reiterated that the company’s pricing and manufacturing approach has aligned with U.S. government priorities, stating the U.S. government receives its lowest price for TPOXX and that active pharmaceutical ingredients and finished drug products are manufactured domestically.
International demand and a new Asia-Pacific order
Nguyen said SIGA continues discussions with governments globally as countries reassess preparedness strategies amid rising biothreat risks and shifting defense budgets. The company recently received a $13 million order from a country in the Asia-Pacific region.
In response to a question about the customer and the structure of the $13 million order, management said it was from a repeat customer, but not the customer referenced by the analyst. The company described it as a multi-year contract that provides the customer flexibility to place additional orders at its discretion, including discretion over size and timing. Management said additional international sales may occur in 2026, while cautioning that these procurement discussions can be complex and take time.
Europe: EMA referral expected to address mpox indication
Nguyen addressed the European Medicines Agency (EMA) referral procedure for TPOXX (Tecovirimat SIGA in Europe), which was initiated in July and was precipitated by results from the mpox clinical trials PALM 007 and STOMP. Nguyen said SIGA has completed two rounds of questions and answers and participated in EMA scientific advisory group meetings, providing what the company described as thorough, science-based responses.
Management said the EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to meet in March to issue its recommendation to the European Commission regarding marketing authorization. SIGA said it expects the CHMP to confirm a positive benefit-risk balance for Tecovirimat SIGA for smallpox, cowpox, and vaccinia complications, maintaining those indications on the label, while recommending withdrawal of the mpox indication based on the mpox trial results.
Nguyen added context on the company’s view of the mpox trial data, stating that TPOXX was developed to reduce mortality and lesion disfigurement by stopping viral dissemination, and that in the mpox trials most patients were treated well past peak viral load and were already progressing toward self-resolution. Management emphasized that speed of treatment is critical in assessing antiviral performance.
Pipeline and development priorities: PEP and pediatrics
Beyond smallpox treatment, Nguyen said the company’s late-stage pipeline efforts continue to focus on a post-exposure prophylaxis (PEP) program, with collaboration with the CDC ongoing and immunogenicity sample analysis underway. SIGA said it is targeting an FDA submission for a PEP indication in the next 12 months.
Nguyen also discussed the pediatric program being advanced in partnership with BARDA to develop an oral suspension formulation for children unable to use capsule formulations. The company said it has filed its IND and initiated a phase I study, with results expected in the second half of the year.
Management noted it secured $27 million in U.S. government funding during 2025 to support pediatric formulation development and IV technology transfer efforts, framing the funding as reinforcement of TPOXX’s role in preparedness planning.
Profitability, cash position, and capital allocation
Luckshire reported pretax operating income (excluding interest income and taxes) of approximately $24 million for 2025. After interest income and taxes, net income was approximately $23 million, translating to $0.32 in fully diluted earnings per share.
On the balance sheet, Luckshire said SIGA ended 2025 with approximately $155 million in cash and no debt.
Asked about capital allocation and the possibility of continued special dividends, Luckshire said the company intends to remain disciplined and flexible, with the goal of long-term value creation. He said it was too early to comment on special cash dividends, noting the company has typically addressed that topic in the March-to-May timeframe. On potential acquisitions or in-licensing, management said it remains open to such opportunities but would approach them in a disciplined and strategic manner.
About Siga Technologies (NASDAQ:SIGA)
Siga Technologies, Inc (NASDAQ: SIGA) is a specialty pharmaceutical company focused on the development, manufacturing and commercialization of medical countermeasures for public health emergencies and biological threats. The company’s flagship product, TPOXX® (tecovirimat), is the first and only antiviral approved by the U.S. Food and Drug Administration for the treatment of smallpox. Siga has entered into procurement and development contracts with U.S. government agencies, including the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense, to supply TPOXX® for the Strategic National Stockpile.
Founded in 2002, Siga has built a pipeline of therapies targeting high-consequence pathogens such as smallpox, plague and other potential biothreat agents.
