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]