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]

Financial Data and Key Metrics Changes - Product revenues for Q1 2025 were approximately $6 million, a decrease from $11 million in Q4 2024, attributed to a sale to a repeat international customer [3][4] - The company reported a pretax operating loss of approximately $2 million and a net loss of approximately $1 million for the quarter, with a fully diluted loss per share of $0.01 [17][18] - As of March 31, 2025, the company had a cash balance of approximately $162 million and no debt, reflecting a strong balance sheet [17][18] Business Line Data and Key Metrics Changes - The U.S. side of the business had about $70 million of outstanding TPOXX orders for the Strategic National Stockpile, with approximately $53 million of oral TPOXX and $9 million of IV TPOXX delivered in April [5][15] - The U.S. Government exercised an option to procure an additional $26 million of IV TPOXX, expected to be delivered in 2026, and modified the current agreement to add $14 million for manufacturing support [6][34] Market Data and Key Metrics Changes - The company has received regulatory approvals for TPOXX in the U.S., Canada, Europe, the U.K., and Japan, indicating a broadening international market presence [4][5] - The international sale of $6 million in Q1 2025 is seen as the beginning of substantial sales growth in the coming months [3][4] Company Strategy and Development Direction - The company aims to reinforce its position in global health security and deliver long-term value to shareholders through strategic partnerships and regulatory approvals [2][12] - Future plans include establishing a comprehensive long-term agreement with the U.S. Government to enhance preparedness against bioterrorism [8][9] - The company is advancing its late-stage pipeline with a focus on TPOXX post-exposure prophylaxis and pediatric programs [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing collaboration with the U.S. Government and the importance of TPOXX in national security [23][25] - The company remains committed to maintaining a strong financial foundation and executing strategic priorities with discipline [12][14] Other Important Information - A special cash dividend of $0.60 per share was declared, reflecting the strength of the balance sheet and confidence in the company's future [11][18] - The company is focused on leveraging its capabilities to move into complementary therapeutic areas as part of its growth strategy [12][13] Q&A Session Summary Question: Expected RFP timeline for PFOX - Management highlighted active engagement with the U.S. Government and positive signals regarding national security and antiviral therapies [21][23] Question: Interim insights from the PET label expansion program - Management confirmed ongoing progress and positive engagement with the FDA and CDC, targeting a supplemental NDA submission in the first half of 2026 [27][28] Question: Potential share buybacks to support investor sentiment - Management indicated a commitment to deploying capital in ways that drive value, including dividends and share repurchases [29][30] Question: Impact of tariffs on international growth efforts - Management stated that current tariffs have not impacted business operations, but they will continue to monitor the macro environment [32][33] Question: Details on the $14 million contract modification - Management described the modification as a positive sign of the administration's commitment to TPOXX and its long-term supply chain resiliency [34][36]

Financial Data and Key Metrics Changes - In Q1 2025, product revenues were approximately $6 million, attributed to a sale to a repeat international customer, compared to an $11 million sale in Q4 2024, indicating a broadening scope of international business [3][4] - The company had a pretax operating loss of approximately $2 million and a net loss of approximately $1 million for the quarter, with a fully diluted loss per share of $0.01 [16] - As of March 31, 2025, the company maintained a strong balance sheet with a cash balance of approximately $162 million and no debt [16][17] Business Line Data and Key Metrics Changes - The U.S. side of the business had about $70 million of outstanding TPOXX orders for delivery to the U.S. Strategic National Stockpile, with approximately $53 million of oral TPOXX and $9 million of IV TPOXX delivered in April [5][15] - The U.S. Government exercised an option under the current contract to procure an additional $26 million of IV TPOXX, expected to be delivered in 2026, and modified the agreement to add $14 million for manufacturing support [6][36] Market Data and Key Metrics Changes - The company has received regulatory approvals for TPOXX in the U.S., Canada, Europe, the U.K., and Japan, indicating a strong international market presence [4][5] - The company expects the $6 million international sale in Q1 to be the start of substantial product sales over the next few months [4][15] Company Strategy and Development Direction - The company aims to reinforce its position as a leader in global health security and deliver long-term value to shareholders through strategic partnerships and regulatory approvals [2][12] - The focus remains on advancing the late-stage pipeline with TPOXX post-exposure prophylaxis program and pediatric program, targeting an FDA submission for PEP indication in the first half of 2026 [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing collaboration with the U.S. Government and the importance of TPOXX in national security, viewing recent government actions as positive signals [22][24] - The company remains committed to maintaining a strong financial foundation and executing strategic priorities with discipline [12][14] Other Important Information - A special cash dividend of $0.60 per share was declared, reflecting the strength of the balance sheet and confidence in the company's future [11][17] - The company continues to monitor the macro tariff environment but has not seen any impact on international growth efforts from recent tariffs [32] Q&A Session Summary Question: What is the expected RFP timeline for PFOX? - Management noted active engagement with the U.S. Government and positive signals regarding national security and antiviral therapies, indicating readiness to engage on an RFP when issued [20][22] Question: Any interim insights from the PET label expansion program? - Management confirmed ongoing progress in the PEP program, with the FDA providing real-time guidance and a target for supplemental NDA submission in the first half of 2026 [26][28] Question: Can we expect share buybacks in the near term? - Management stated that capital deployment will focus on driving value through dividends, share repurchases, or investments in growth and innovation [29][30] Question: Impact of tariffs on international growth efforts? - Management indicated that announced tariffs have not impacted business operations, emphasizing the importance of a U.S.-based supply chain [32] Question: Details on the modification to the 19C contract? - Management highlighted the $14 million contract modification as a sign of the administration's commitment to TPOXX and its importance in the stockpile for long-term supply chain resiliency [36]

Financial Data and Key Metrics Changes - In 2024, SIGA reported product sales of $133 million, an increase of approximately 2% from 2023, marking the second consecutive year of sales growth [4][28] - For the fourth quarter of 2024, product sales were approximately $80 million, with $51 million from oral TPOXX and $9 million from IV TPOXX delivered to the Strategic National Stockpile [5][29] - Net income for the full year 2024 was approximately $59 million, with fully diluted income per share at $0.82 [32] Business Line Data and Key Metrics Changes - The revenue mix for 2024 included $74 million from oral TPOXX sales to the Strategic National Stockpile, $26 million from IV TPOXX sales, and $23 million from international customers [30] - The fourth quarter saw a notable international sale of $11 million for oral TPOXX in East Asia, more than double the size of the largest prior individual sale in the region [6][29] Market Data and Key Metrics Changes - SIGA has made significant progress in international markets, including a regulatory approval for TPOXX in Japan, which is expected to enhance global access [9][10] - The company has begun building an international sales and marketing infrastructure to support its growth in these markets [8] Company Strategy and Development Direction - SIGA is focused on expanding its TPOXX franchise and enhancing its international presence while cultivating strategic partnerships, such as the exclusive license for monoclonal antibodies from Vanderbilt University [11][12] - The company aims to secure a new contract for TPOXX with the Strategic National Stockpile, which is seen as a long-term opportunity for growth [22][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the importance of TPOXX as a countermeasure for smallpox, especially given the potential for its reintroduction due to diminished herd immunity [14][15] - The company is monitoring changes in U.S. government administration and believes that national security remains a priority that transcends political considerations [23][25] Other Important Information - SIGA maintained a strong balance sheet with a cash balance of $155 million and no debt as of December 31, 2024 [33] - The company has a $70 million outstanding order balance expected to be delivered in 2025 [33] Q&A Session Summary Question: Updates on oral TPOXX deliveries and expected timelines - Management confirmed that $70 million of outstanding orders primarily consist of oral and IV TPOXX deliveries, expected to start in the second quarter of 2025 [38][39] Question: Potential for special dividends given strong cash position - Management indicated that a capital management decision regarding special dividends is anticipated in the second quarter of 2025, consistent with prior years [44] Question: Details on international growth and distribution agreements - The distribution agreement with Japan Biotechno Pharma has not been disclosed, but it is noted to be more efficient than previous agreements [46] Question: Future of mpox opportunity and trial adjustments - Management is analyzing clinical data from mpox trials to determine the best path forward for treatment regimens [50][53] Question: Impact of NIH funding cuts on RFP for TPOXX - Management emphasized the importance of maintaining strong partnerships with U.S. government agencies and believes national security remains a priority [56][57] Question: Re-engagement with BARDA and potential contract volume - Management stated ongoing discussions with BARDA regarding the importance of tecovirimat for smallpox preparedness, but specific volume requirements have not yet been identified [66] Question: Inventory details and its relation to outstanding orders - The inventory balance includes products for the $70 million outstanding orders and a fair amount of active pharmaceutical ingredients (API) for future orders [69] Question: Fallout from Dr. Varma's comments on TPOXX efficacy - Management refuted any significant impact from Dr. Varma's comments, asserting confidence in the science and data supporting TPOXX [72][73] Question: Plans for portfolio diversification beyond TPOXX - Management expressed intentions to pursue portfolio diversification while maximizing the TPOXX franchise [76]