Release Date: March 04, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: As we start the year, should we expect a flat trajectory for DANYELZA's revenue in 2025, or will there be fluctuations due to seasonal impacts or other factors? A: Michael Rossi, CEO: We plan to accelerate growth in 2025, which will involve ramping up efforts to penetrate the high-risk neuroblastoma market and explore other opportunities. Pete Pfreundschuh, CFO: Our guidance reflects potential seasonal and stocking effects, with a wide range for the full year. We suggest focusing on the midpoint of our guidance range for modeling purposes.
Q: Regarding the upcoming SADA update, which tissues are most important to measure for dose selection outside the tumor? A: Doug Gentilcore, DANYELZA Business Unit Head: Key areas to monitor include the kidneys, liver, and bone marrow, as these could be dose-limiting. It's crucial to assess not just concentration but also potential injury from systemic radiotherapy.
Q: Can you provide a breakdown of the 2025 OpEx guidance between R&D and SG&A, and how should we think about R&D spending as the SADA program ramps up? A: Michael Rossi, CEO: We are optimizing our R&D process to bring targets into clinical trials more efficiently. Pete Pfreundschuh, CFO: Our SG&A costs for 2024 included one-time charges, so expect a slight increase from the adjusted base. The remainder of the OpEx will be R&D-focused.
Q: How are you managing the shift in R&D spend from DANYELZA to investigator-sponsored studies, and what impact could this have on revenue beyond 2025? A: Michael Rossi, CEO: We are completing our post-marketing commitment trial and supporting investigator-sponsored trials to increase market penetration and explore new indications. This could provide long-term benefits despite short-term competition for patients.
Q: What are the challenges in enrolling the first patient for the CD38 program, and how does this relate to the SADA platform? A: Michael Rossi, CEO: The main challenge is patient qualification in a difficult segment, unrelated to the SADA platform. We've activated five sites and are working to enroll patients in this refractory non-Hodgkin's lymphoma trial.
Q: Can you provide more details on the bridging study for GD2-SADA and the timelines for Part B and C? A: Natalie Tucker, Radiopharmaceutical Business Unit Head: The bridging study for Part B is expected to start in early 2026 and will be quicker than Part A. We plan to provide a full update in Q2, including timelines for Part C.
Q: How do you plan to manage the competitive dynamics for DANYELZA, especially with new market entrants? A: Michael Rossi, CEO: We are leveraging clinical trials to increase market share and penetration. Doug Gentilcore, DANYELZA Business Unit Head: We are focusing on new patient starts and positive feedback from investigators to drive growth.
Q: What is the unmet need for the CD38 program, and what level of benefit is needed for clinical and commercial success? A: Michael Rossi, CEO: The CD38 program addresses an unmet need in non-Hodgkin's lymphoma. The goal is to validate the target and compare data across different tumor types to determine the program's viability.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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