Release Date: November 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you discuss the price mix dynamics for Danyelza in the quarter and expectations moving forward? A: Sue Smith, Chief Commercial Officer, explained that they took an approximate $1.5 million charge in Q3 for Medicaid-related claims, which led to a 5% decline in net revenues despite a 5% increase in sales volume. Without this adjustment, sales would have been up 4% year-over-year and quarter-over-quarter.
Q: What are the key criteria for dose selection in the GD2 SADA study? A: Michael Rossi, CEO, stated that they started with a 0.3 mg/kg dose and escalated to 3 mg/kg before settling at 1 mg/kg. This decision was based on preclinical PK data, aiming to match blood levels and ensure optimal dosing near the no observed adverse effect level (NOAEL).
Q: What are the swing factors for Q4 revenues, and how confident are you in hitting the lower end of the guidance? A: Peter Pfreundschuh, CFO, expressed confidence in landing within the guidance range of $87 to $95 million, likely in the lower half. He noted that adjustments for cyclone sales, Medicaid, and the Noble licensing deal would have aligned Q3 results with consensus expectations.
Q: Can you comment on the radio sensitivity of the tumor types in the GD2 SADA study? A: Vignesh Rajah, Chief Medical Officer, mentioned that the study includes osteosarcoma, melanoma, soft tissue sarcoma, small cell lung cancer, and adult neuroblastoma. It's too early to determine radiation sensitivity, but they are evaluating dosimetry and responses.
Q: What is your approach to manufacturing with the new headquarters, and how do you see the commercial rollout in Japan? A: Michael Rossi, CEO, stated that they continue to use contract manufacturing for proteins, allowing investment in drug development rather than infrastructure. For Japan, a small clinical trial is planned, with a potential launch in late 2025 or early 2026, though the market is smaller than the US.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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