Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- SIGA Technologies Inc (SIGA, Financial) secured $122 million in procurement orders in the third quarter, sustaining strong business momentum.
- The company has a diverse mix of revenue sources, including significant sales to the US strategic national stockpile and international markets.
- Outstanding procurement orders at the end of the third quarter were $146 million, positioning SIGA for substantial future revenues.
- SIGA is in ongoing discussions with government officials to secure a new contract for TPOXX, enhancing long-term earnings potential.
- The company has licensed a portfolio of monoclonal antibodies from Vanderbilt University, expanding its pipeline and offering new growth opportunities.
Negative Points
- The manufacturing process for IV TPOXX is more complex and requires longer lead times, potentially delaying deliveries.
- There are uncertainties regarding the timing of necessary steps for securing new contracts due to anticipated changes in the federal government.
- The recent trial for mpox treatment did not meet its primary endpoint, indicating challenges in demonstrating TPOXX's efficacy for this indication.
- There are reports of some mpox patients developing resistance to TPOXX, although the incidence remains low.
- The exact timing for the clinical development of the newly licensed monoclonal antibodies is still uncertain.
Q & A Highlights
Q: What are the reasons for the protracted deliveries of IV TPOXX compared to oral TPOXX? Are there supply chain constraints, and when can we expect orders for IV TPOXX to be delivered?
A: The manufacturing process for IV TPOXX is more complex than for oral TPOXX, involving different vendors and raw materials, leading to longer lead times. Deliveries are also dependent on customer preferences. Deliveries have started and will continue into 2025. - Diem Nguyen, CEO
Q: Can you provide insights into the internationalization efforts following the amendment with Meridian? What opportunities or challenges are you seeing?
A: The amendment has allowed SIGA to bring international marketing and sales in-house, enhancing control and customer relationships. The recent sale to Africa is a positive start, and no challenges have been experienced in this transition. - Diem Nguyen, CEO
Q: Could you provide more details on the new preclinical program licensed from Vanderbilt? When might it enter clinical studies, and will it be developed as a monotherapy or combination therapy with TPOXX?
A: The monoclonal antibody portfolio from Vanderbilt has potential for treating a broad spectrum of orthopox viruses. It could be used as a standalone treatment or in combination with TPOXX. The DOD is funding its development through phase one, but it's premature to discuss timing for clinical studies. - Diem Nguyen, CEO
Q: There have been reports of mpox patients being resistant to TPOXX. Is this a concern for SIGA?
A: Resistance remains low, at less than 1% in the patient population, primarily in immunocompromised patients. The recent CDC report noted resistance in a small sample, but lacked comprehensive data. DNA viruses like smallpox and mpox mutate less easily than RNA viruses, contributing to low resistance levels. - Diem Nguyen, CEO
Q: When can we expect the latest order from the Department of Defense to be delivered?
A: Deliveries under the Department of Defense contract have already started and will continue into 2025. - Diem Nguyen, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
