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SIGA Technologies(SIGA) - 2021 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q3 2021, SIGA's revenue was approximately $4.8 million, with $18.3 million for the nine months ended September 30, 2021, showing a significant increase in international product sales by approximately $10 million compared to the same period in 2020, representing more than a fourfold increase [31][32] - The operating loss for Q3 2021 was approximately $2.9 million, while the net loss was approximately $3.1 million, with a fully diluted loss per share of $0.04 for Q3 and $0.05 for the nine months ended September 30, 2021 [32][33] Business Line Data and Key Metrics Changes - The company delivered approximately $33 million of oral TPOXX to the U.S. government in October 2021, with a cumulative value of $113 million targeted for multiple deliveries in Q4 2021 [6][7] - SIGA delivered $2.3 million of oral TPOXX to the Canadian military during Q3 2021, ahead of schedule [17] Market Data and Key Metrics Changes - The company is actively pursuing international sales, generating approximately $13 million of revenue year-to-date from international sales initiatives, compared to $2 million in 2020 [39] - SIGA is optimistic about future sales potential as it gains EMA approval and engages in advanced discussions with customers in Europe, the Middle East, and Asia [20] Company Strategy and Development Direction - SIGA is focusing on expanding its government portfolio products and contracts through collaborations, such as with Cipla, and anticipates responding to an upcoming BARDA RFP for antibiotics [41][42] - The company is also working on broadening the U.S. customer base, potentially including the U.S. Department of Defense [42] Management's Comments on Operating Environment and Future Outlook - Management highlighted ongoing supply chain challenges but emphasized efforts to ensure timely delivery of TPOXX [7] - The company is preparing for a potential transition to a longer-term 10-year contract with the U.S. government, which could provide a more consistent product delivery timeline [9][48] Other Important Information - SIGA has approximately $93 million in cash as of September 30, 2021, and has repurchased approximately 7.7 million shares of its common stock since the inception of its share repurchase program [34] - The company is targeting regulatory approvals for IV TPOXX and EMA MAA applications in early 2022, with ongoing clinical trials for TPOXX in monkeypox patients [21][22][25] Q&A Session Summary Question: Potential contract transition to a 10-year contract - Management indicated that predicting the U.S. government's timeline is difficult, but historically, there is usually a multi-year transition after FDA approval [46][48] Question: Existing label for TPOXX and future sales - Management confirmed that the current label for TPOXX is for stockpiling only, but discussions for broader sales are ongoing as regulatory processes progress [52][54] Question: Virulence of monkeypox clades - It was confirmed that Central African monkeypox clades are more virulent, but TPOXX is expected to be effective against both Central and West African clades [56] Question: Solubility issues with ST-357 - Management acknowledged the identification of solubility issues and plans for a chemistry optimization campaign to address them [58] Question: Department of Defense's interest in TPOXX - Management expressed excitement about the DoD's notice of intent to purchase TPOXX and emphasized the importance of having a contract vehicle for future business opportunities [62][63]