SIGA TECHNOLOGIES INC Q3 FY2024 earnings call

• Secured $122 million of procurement orders in the third quarter, with $146 million of outstanding procurement orders at the end of the third quarter.
• Product sales year-to-date include diverse revenue sources like oral and IV TPOXX deliveries to the US Strategic National Stockpile and international sales, including first oral TPOXX sales in Africa.
• Focus on securing a new contract for continuing supply of TPOXX to the Strategic National Stockpile, with ongoing conversations with government officials.
• Announced exclusive license to pre-clinical, fully human monoclonal antibodies from Vanderbilt University for treating orthopoxviruses.
• TPOXX post-exposure prophylaxis program collaboration with CDC and FDA, planning FDA submission in third quarter of 2025.
• Updates on mpox trials, including STOMP trial enrolling patients, and TPOXX's safety profile and efficacy data.
• Active discussions with Japan Biotechno Pharma and regulators regarding TPOXX's new drug application for smallpox, mpox, etc., with expected regulatory decision by early next year.

For the nine months ended September 30, 2024, product revenue was $53 million. This included $23 million of oral TPOXX sales to the US Government under the 19C contract, $17 million of IV TPOXX sales to the US Government under the 19C contract, $12 million of international oral TPOXX sales to 12 countries, and $1 million of oral TPOXX sales to the US Department of Defense. Research and development revenues were $1 million for the three months ended September 30, 2024, and $4 million for the nine months ended September 30, 2024. Pre-tax operating income was $0.5 million for the three months ended September 30, 2024, and $13 million for the nine months ended September 30, 2024. Net income was $1 million for the three months ended September 30, 2024, and $13 million for the nine months ended September 30, 2024. Fully diluted income per share was $0.02 for the three months ended September 30, 2024, and $0.19 for the nine months ended September 30, 2024. As of September 30, 2024, the company had a cash balance of $99 million with no debt.

• Targeting issuance of a new SNS contract in 2025, which would include initial orders.
• Substantial revenues expected in the fourth quarter of 2024 and into 2025 due to outstanding order balance of $146 million as of September 30, 2024.

• Media reports on mpox patients being resistant to TPOXX. Diem noted low resistance (less than 1% in patient population), primarily in immunocompromised patients with extended treatment, and DNA viruses like smallpox and mpox mutate less than RNA viruses, contributing to low resistance observed to date.

Q: What are the reasons for the difference in delivery times between IV and oral TPOXX, and when can we expect IV TPOXX orders to be delivered?

A: The manufacturing process for IV TPOXX is more complex than oral, with longer lead times. Deliveries of IV and oral TPOXX are partially dependent on customer delivery timing, with orals from the last contract tranche starting in 2024 and continuing into 2025.

Q: What traction, opportunities, or challenges are you seeing in international markets since amending the Meridian agreement?

A: Amending the agreement gave greater control over international business. They've been strengthening relationships with global customers, with the recent sale to Morocco as a good start. No challenges experienced in the transition so far.

Q: Can you provide more details on the licensed pre-clinical program, deal economics, and when it might enter clinical studies?

A: Excited about the in-license of monoclonal antibodies from Vanderbilt. They have potential to treat orthopoxviruses. DoD funded development through Phase 1 with a third party. Timing of clinical studies is premature to discuss yet.

Q: What's your perspective on media reports of mpox patients being resistant to TPOXX?

A: Preclinical evidence shows no resistance in animals. CDC reports low resistance (less than 1%) in patients, primarily in immunocompromised patients with extended treatment. The finding warrants further investigation, but DNA viruses mutate less, contributing to low resistance observed to date.