Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, product revenue totaled approximately $86 million, which includes $53 million from oral TPOXX and $26 million from IV TPOXX sales under the 19C BARDA contract, and $6 million from international sales. This represents an increase from $54 million in the comparable period last year [3][13][15] - Pre-tax operating income for the nine months ended September 30, 2025, was approximately $33 million, while for the three months ended September 30, 2025, there was a pre-tax operating loss of approximately $10 million. Net income for the nine months was approximately $29 million, with a fully diluted income per share of $0.40. For the three months ended September 30, 2025, the net loss was approximately $6 million, resulting in a net loss per share of $0.09 [15][16] Business Line Data and Key Metrics Changes - The third quarter was relatively quiet, following a strong second quarter with $79 million in product revenues. The fluctuations in revenue are consistent with SIGA's business model, which should be assessed beyond quarterly results [3][14] - As of the end of the third quarter, there were approximately $26 million of outstanding orders remaining from the U.S. government related to IV TPOXX, expected to be delivered in 2026 [4][15] Market Data and Key Metrics Changes - The company continues to engage with the U.S. government regarding future TPOXX development, manufacturing, and procurement, with $27 million awarded for pediatric formulation development and IV tech transfer activities [4][5] - SIGA is actively involved in discussions with international stakeholders to enhance global health security frameworks, anticipating multiple international sales in 2026 [5][7] Company Strategy and Development Direction - SIGA's mission focuses on supporting governments in preparedness plans for potential smallpox outbreaks, emphasizing the importance of rapid deployment of antiviral treatments [2][3] - The company aims to maintain a strong financial position while executing strategic initiatives, with a focus on long-term government partnerships and a commitment to global health security [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing engagement with the U.S. government despite potential delays due to the government shutdown, highlighting the importance of TPOXX as a critical countermeasure for smallpox [20] - The company remains optimistic about its strong cash position of approximately $172 million, which provides flexibility to adapt to changing environments and pursue opportunities while managing risks [23] Other Important Information - The European Medicines Agency (EMA) is reviewing TPOXX's efficacy in treating Mpox, with the Committee for Medicinal Products for Human Use (CHMP) expected to meet soon to discuss the submitted data [8][9] - SIGA's pediatric program is progressing, with plans to submit an IND by the end of the year and initiate phase one trials shortly thereafter [10] Q&A Session Summary Question: Impact of U.S. government shutdown on TPOXX RFP process - Management indicated that operational activities have not been materially impacted by the government shutdown, although there may be delays in CDC analysis related to the PEP program [19][20] Question: Mitigation strategies for potential RFP delays - Management emphasized the strong cash position and adaptability of SIGA, which allows for flexibility in pursuing opportunities while managing risks [22][23] Question: Clarification on Q3 product revenues and cost of goods sold - Management explained that the product revenues in Q3 were influenced by accounting treatments related to reimbursement activities, and the higher cost of goods sold was due to variable production costs and semi-fixed expenses [24][25][26]

Core Insights - Healthcare stocks have remained stagnant since April, contrasting with a 27% rise in the S&P 500, which raises interest for contrarian investors [2] - Seven healthcare stocks offer yields up to 7.1%, indicating potential investment opportunities due to their underperformance relative to the broader market [2] Group 1: High Yield Healthcare Stocks - Omega Healthcare Investors (OHI) has a yield of 6.4% and operates skilled nursing and assisted living facilities, with a portfolio of 93,961 beds across over 1,000 properties [3] - OHI has shown progress by beating estimates for adjusted funds from operations (AFFO) and raising its full-year AFFO guidance, while also acquiring 57 properties [4] - LTC Properties (LTC) offers a 6.3% yield and is transitioning some contracts to RIDEA-structured contracts, which could enhance growth potential [7][8] - Healthpeak Properties (DOC) has a yield of 7.0% and a diversified portfolio, but may face growth challenges due to headwinds in its life sciences segment [10] - Sila Realty Trust (SILA) has a yield of 6.4% and has shown a nearly 20% total return since its IPO, with a strong financial position [11][12] - Siga Technologies (SIGA) offers a high yield of 7.1% but is concentrated on a single product, TPOXX, which limits diversification [13][21] - Bristol-Myers Squibb (BMY) has a yield of 5.3% and a market cap of nearly $100 billion, but has underperformed significantly over the past five years [14][15] - Pfizer (PFE) has a yield of 6.9% and is facing challenges with declining COVID drug sales and upcoming patent expirations, leading to a high yield not seen since the Great Recession [18][19] Group 2: Market Context and Challenges - The healthcare sector is facing uncertainties including potential cuts to Medicaid, health research funding, and initiatives aimed at lowering drug costs [6] - The overall healthcare market has underperformed compared to the S&P 500, with BMY experiencing a 25% decline in price over the past five years [15] - Pfizer is targeting over $7 billion in cost savings by the end of 2027, but its long-term prospects depend on the success of its product pipeline [19][20]

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]

Company Overview A Leader in Global Health & Infectious Diseases 1 Forward Looking Statements 2 Contents Introduction 1 The Smallpox Threat 2 TPOXX®: A Differentiated Product 3 Financial Summary 4 SIGA at a Glance Stellar Revenue Generation >$1bn of Procurement Contracts from 10+ years Working with Governments 30+ Countries Where Products Have Been Sold We are dedicated to advancing our strategic initiatives, driving shareholder value, and enhancing national health security as we deliver TPOXX to U.S. and g ...

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]