SIGA Technologies(SIGA) - 2024 Q2 - Quarterly Report

TPOXX® Deliveries and Contracts - The company has delivered approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, receiving $11.1 million in payments[77] - The 19C BARDA Contract includes potential payments up to approximately $602.5 million, with $519.6 million in exercised options and $31.2 million in unexercised options as of July 18, 2024[76][79] - The company has cumulatively delivered $337.7 million worth of oral TPOXX® to the Strategic Stockpile as of June 30, 2024[78] - The company fulfilled a $5.1 million firm commitment under DoD Contract 2 in March 2023 and delivered an additional $5.5 million of oral TPOXX® in Q4 2023[84] TPOXX® Sales and Revenue - International sales of oral TPOXX® totaled $3.0 million and $11.0 million for the three and six months ended June 30, 2024, respectively, across 11 countries[85] - Revenues from product sales and supportive services for the three months ended June 30, 2024 were $20.7 million, including $17.6 million from IV TPOXX® sales to the U.S. Government and $3.1 million from oral TPOXX® international sales[93] - Revenues from product sales and supportive services for the six months ended June 30, 2024 were $44.6 million, including $17.6 million from IV TPOXX® and $14.7 million from oral TPOXX® sales to the U.S. Government, and $11.0 million from international sales[98] TPOXX® Research and Development - The company is targeting a Supplemental NDA filing for smallpox post-exposure prophylaxis (PEP) indication for oral TPOXX® within the next twelve months[73] - Four randomized, placebo-controlled clinical trials for TPOXX® as an mpox treatment are active as of June 30, 2024, with one trial completed and three still enrolling patients[74] - The company’s partner in Japan, Japan Biotechno Pharma, filed a new drug application for oral TPOXX® for smallpox, mpox, cowpox, and vaccinia complications on April 11, 2024[75] Financial Performance and Expenses - Revenues from research and development activities for the three months ended June 30, 2024 decreased by $3.5 million to $1.1 million, primarily due to the completion of billable activities under the PEP Label Expansion R&D Contract[94] - Cost of sales and supportive services for the three months ended June 30, 2024 were $12.3 million, associated with the manufacture and delivery of IV and oral TPOXX® to the U.S. Government and international countries[95] - Selling, general and administrative expenses for the three months ended June 30, 2024 increased by $1.1 million to $5.5 million, reflecting higher promotion fees and compensation expenses[96] - Research and development expenses for the three months ended June 30, 2024 decreased by $2.2 million to $2.9 million, primarily due to lower vendor-related expenses under the PEP Label Expansion R&D Contract[96] - Revenues from research and development activities for the six months ended June 30, 2024 decreased by $4.5 million to $2.7 million, primarily due to the completion of billable activities under the PEP Label Expansion R&D Contract[99] - Cost of sales and supportive services for the six months ended June 30, 2024 were $15.5 million, associated with the manufacture and delivery of IV and oral TPOXX® to the U.S. Government and international countries[100] - Selling, general and administrative expenses for the six months ended June 30, 2024 increased by $4.7 million to $13.4 million, reflecting higher international promotion fees and compensation expenses[101] Financial Position and Controls - As of June 30, 2024, the company had $106.9 million in cash and cash equivalents, compared to $150.1 million at December 31, 2023[105] - SIGA's disclosure controls and procedures were deemed effective as of June 30, 2024[113] - No material changes in SIGA's internal control over financial reporting occurred during the quarter ended June 30, 2024[114] Risks and Legal Matters - SIGA's forward-looking statements include risks related to the BARDA Contract, potential delays in product delivery, and uncertainties in the international biodefense market[111] - SIGA may face legal proceedings, but believes current matters will not have a material adverse effect on its business[116] Investment Strategy - SIGA's investment portfolio is conservative, focusing on capital preservation and avoiding derivative financial instruments[112] International Agreements - The International Promotion Agreement with Meridian provides a high single-digit percentage fee to Meridian for sales in specified territories, effective until May 31, 2026[86] Gross Margins - The company estimates gross margins for IV TPOXX® sales under the 19C BARDA Contract to be less than 40% if remaining IV FDP options are exercised[81]