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]