Jyoti Prakash

Jyoti Prakash from Edison Group inquired about the timing of the next U.S. government RFP for TPOXX, SIGA's capital allocation priorities including special dividends and M&A, and details regarding the recent $13 million international TPOXX order from the Asia-Pacific region.

Answer

CEO Diem Nguyen confirmed ongoing U.S. government focus on smallpox preparedness and TPOXX's role, but provided no specific RFP timing. She also stated SIGA's disciplined approach to M&A. CFO Daniel Luckshire noted capital management aims for long-term shareholder value, with special dividend timing to be addressed later (March-May). He clarified the $13 million international order was from a repeat, multi-year Asia-Pacific customer (not the 2019-2024 one), with future orders at their discretion, and that additional international sales in 2026 are possible but complex.

Jyoti Prakash from Edison Group inquired about the timing of the next U.S. government RFP for TPOXX, noting recent BARDA activity and ongoing smallpox preparedness efforts. He also asked about SIGA's capital allocation priorities, including potential special dividends and openness to M&A or in-licensing opportunities. Finally, he sought more details on the recent $13 million international TPOXX order, its customer, contract duration, and expectations for additional international sales.

Answer

CEO Diem Nguyen highlighted the U.S. government's continued focus on smallpox preparedness, citing recent TPOXX deliveries and development funding, and confirmed ongoing productive discussions with HHS and ASPR, though no specific RFP timing was provided. CFO Daniel Luckshire addressed capital allocation, stating a disciplined and flexible approach, and mentioned that special dividend discussions typically occur between March and May. CEO Diem Nguyen confirmed the company's capability and strategic discipline for pursuing M&A or in-licensing. Regarding international orders, CFO Daniel Luckshire confirmed the $13 million multi-year order was from a repeat Asia-Pacific customer, distinct from the 2024 customer, and indicated active engagement for potential future international sales, while noting the complexity and time required for such discussions.

Jyoti Prakash from Edison Group asked about the deployment of the $13 million BARDA funding for the pediatric program, the impact of the European CHMP's data request on international growth plans, the timeline for the next U.S. government RFP, and the status of the preclinical monoclonal antibody program licensed in 2024.

Answer

CEO Diem Nguyen explained the BARDA funds will support the pediatric program through regulatory filing and detailed the upcoming crossover study design. CFO Daniel Luckshire stated that international orders are expected to be lumpy but the long-term opportunity remains significant, highlighting $135 million in sales to 30 countries since 2020. He also noted it is difficult to predict the exact U.S. RFP timing but SIGA is well-positioned. CEO Diem Nguyen concluded by stating the company is assessing the development path for its monoclonal antibody assets.

Jyoti Prakash asked about the expected timeline for the U.S. government's RFP for a new TPOXX contract, any interim insights from the PEP label expansion program, the potential for share buybacks, the impact of tariffs on international growth, and for more details on the recent $14 million 19C contract modification.

Answer

CEO Diem Nguyen addressed the U.S. government relationship, stating that recent orders and funding modifications are positive signals of TPOXX's value, and noted SIGA's long history of collaboration across multiple administrations. For the PEP program, she confirmed the FDA is actively engaged and a submission is targeted for H1 2026, pending CDC sample analysis completion in Q4. She also explained the $14 million contract modification is to fund a tech transfer for the IV formulation to a new manufacturer, enhancing long-term supply chain resiliency. CFO Daniel Luckshire commented on capital allocation, stating the board considers all options, including buybacks, but views the current special dividend as a substantial return of capital. He also confirmed that tariffs have not impacted the business to date, highlighting the benefit of a U.S.-based supply chain.

Jyoti Prakash inquired about the delivery timeline for the remaining $70 million in TPOXX orders, the likelihood of another special dividend, details of the distribution agreement in Japan, the customer for the recent $11 million international sale, plans for mpox trials following recent results, and the potential impact of the new U.S. administration's funding policies on the upcoming TPOXX RFP.

Answer

CFO Daniel Luckshire stated the $70 million in orders will be delivered in 2025, starting in Q2, and this is separate from the RFP process. He also indicated a capital management decision is anticipated in Q2 2025. Regarding international business, Luckshire noted the Japan agreement terms are undisclosed but more efficient than prior deals, and declined to name the customer for the $11 million sale. CEO Diem Nguyen addressed the mpox trials, explaining that SIGA is analyzing subgroup data with sponsors and that future trial designs will incorporate these learnings. She also expressed confidence that national security transcends politics and that SIGA is well-positioned to engage with the new administration on the TPOXX contract.

Jyoti Prakash of H.C. Wainwright & Co. asked about several key operational areas, including the reasons for different delivery timelines between oral and IV TPOXX, the expected delivery schedule for the Department of Defense order, traction and challenges in international markets following the amendment of the Meridian agreement, details on the newly in-licensed monoclonal antibody program, and SIGA's perspective on recent reports of TPOXX resistance in mpox patients.

Answer

Diem Nguyen, an executive at SIGA, explained that the manufacturing process for IV TPOXX is more complex and has longer lead times than the oral formulation, causing different delivery schedules. She confirmed that since bringing international marketing in-house, SIGA has seen positive traction, highlighted by a sale in Morocco, with no transition challenges. Regarding the new preclinical program, Nguyen noted it offers a cost-effective pipeline expansion as the Department of Defense is funding development through Phase I. Finally, she addressed resistance concerns by stating that clinically observed resistance is very low (<1%), primarily in specific patient groups, and that the underlying DNA nature of the mpox virus makes resistance less likely than in RNA viruses.