Financial Data and Key Metrics Changes - In Q2 2025, SIGA achieved product revenues of approximately $79 million, consisting of $53 million from oral TPOXX and $26 million from IV TPOXX delivered to the U.S. Strategic National Stockpile [3][15] - For the six months ended June 30, 2025, product sales totaled $85 million, with research and development revenues of approximately $2 million and $3 million for the three and six months, respectively [16] - The company reported a pretax operating income of approximately $46 million for the quarter and $43 million for the six months, with net income of approximately $35 million for both periods [17] Business Line Data and Key Metrics Changes - The significant product revenues were driven by the delivery of TPOXX formulations, fulfilling outstanding orders from the U.S. government [3][4] - The company received an additional $27 million in development funding from the U.S. government, which includes $14 million for manufacturing activities and $13 million for the pediatric program [5][6] Market Data and Key Metrics Changes - The U.S. government has approximately $26 million of remaining outstanding orders related to IV TPOXX, expected to be delivered in 2026 [4][17] - Internationally, SIGA has sold $135 million of TPOXX to 30 countries since 2020, indicating a growing international market opportunity [25] Company Strategy and Development Direction - SIGA aims to establish a new comprehensive long-term agreement with the U.S. government to reflect the value of TPOXX, enhancing national bioterrorism preparedness and global health security [6][7] - The company is focused on advancing regulatory approvals for TPOXX and new indications, cultivating strategic partnerships, and expanding into complementary therapeutic areas [13][14] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of maintaining both oral and IV formulations of TPOXX to ensure flexibility in response strategies for smallpox treatment [6] - The company remains committed to supporting global health security and public health resilience amid rising threats from infectious diseases and bioterrorism [7][9] Other Important Information - The European Medicines Agency's Committee raised questions regarding the efficacy of ticavirumab in treating ENPOXX, which the company is addressing through a detailed response [10][11] - SIGA is advancing its late-stage pipeline for TPOXX post-exposure prophylaxis and pediatric programs, with an IND submission targeted for 2026 [12][13] Q&A Session Summary Question: Regarding the $13 million BARDA funding for the pediatric program, how will the funds be deployed and what is the trial design? - Management explained that the funding will support development activities up to regulatory filing, with a follow-up trial planned to evaluate a refined formulation for pediatric use [21][22] Question: How does the CHMP's request for additional data impact international growth plans? - Management noted that they are building relationships globally and expect international orders to be lumpy, but see significant potential in the international market [24][25] Question: What are the timelines for the RFP process and lead time between order receipt and delivery? - Management indicated that while they cannot speculate on exact timing, they are well-positioned to engage with the U.S. government on RFPs and have a history of efficient negotiation processes [26][29][30] Question: What is the current status of the preclinical monoclonal antibody program? - Management expressed enthusiasm for the monoclonal antibodies' potential and is determining the best path forward for development and manufacturing [32][34]