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SIGA Technologies(SIGA) - 2024 Q2 - Quarterly Report
SIGASIGA Technologies(SIGA)2024-08-01 20:59
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TPOXX® Deliveries and Contracts - The company has delivered approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, receiving 11.1millioninpayments[77]−The19CBARDAContractincludespotentialpaymentsuptoapproximately11.1 million in payments[77] - The 19C BARDA Contract includes potential payments up to approximately 602.5 million, with 519.6millioninexercisedoptionsand519.6 million in exercised options and 31.2 million in unexercised options as of July 18, 2024[76][79] - The company has cumulatively delivered 337.7millionworthoforalTPOXX®totheStrategicStockpileasofJune30,2024[78]−Thecompanyfulfilleda337.7 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 5.5millionoforalTPOXX®inQ42023[84]TPOXX®SalesandRevenue−InternationalsalesoforalTPOXX®totaled5.5 million of oral TPOXX® in Q4 2023[84] TPOXX® Sales and Revenue - International sales of oral TPOXX® totaled 3.0 million and 11.0millionforthethreeandsixmonthsendedJune30,2024,respectively,across11countries[85]−RevenuesfromproductsalesandsupportiveservicesforthethreemonthsendedJune30,2024were11.0 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 17.6millionfromIVTPOXX®salestotheU.S.Governmentand17.6 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 44.6million,including44.6 million, including 17.6 million from IV TPOXX® and 14.7millionfromoralTPOXX®salestotheU.S.Government,and14.7 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 3.5millionto3.5 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 12.3million,associatedwiththemanufactureanddeliveryofIVandoralTPOXX®totheU.S.Governmentandinternationalcountries[95]−Selling,generalandadministrativeexpensesforthethreemonthsendedJune30,2024increasedby12.3 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 5.5million,reflectinghigherpromotionfeesandcompensationexpenses[96]−ResearchanddevelopmentexpensesforthethreemonthsendedJune30,2024decreasedby5.5 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 4.7millionto4.7 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 106.9millionincashandcashequivalents,comparedto106.9 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]