Release Date: April 30, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: What are some possible explanations for the negative dynamics for NGENLA? Is it more likely competition, access issues, or something commercial related to Pfizer? A: Adam Logal, CFO, explained that the growth rates of prescriptions for both NGENLA and GENOTROPIN continue, suggesting the issue might be related to the commercial environment. They expect this to be a first-quarter-only event, which is why the guidance was only slightly reduced.
Q: Could you comment on why Pfizer withdrew their EU application for the adult setting and what are the plans for expansion into additional settings? A: Adam Logal, CFO, noted that Pfizer is focusing on expanding the label for NGENLA, particularly in pediatric indications due to the larger market size compared to adults. The decision to withdraw the EU application for adults was likely strategic to focus efforts on pediatric indications.
Q: Could you provide a rough timeline for the development program of the GLP-1/Glucagon tablet candidate? A: Adam Logal, CFO, stated that they expect to file an IND by the end of this year or early next year, with trial commencement thereafter. Results from a Phase I trial could be available by the end of 2026, with expected once-weekly dosing.
Q: What are the next steps for the subcutaneous obesity and MASH program, and how do you anticipate differentiating the oral formulation? A: Elias Zerhouni, President, explained that both the subcutaneous and oral formulations are in the pre-IND phase. The focus is on safety and dose range in Phase I trials. The oral formulation is once a day, while the subcutaneous is once a week, with a focus on liver diseases affected by fatty liver disease.
Q: Can you provide an update on the Epstein-Barr virus (EBV) trial and any efficacy signals that might de-risk the asset? A: Elias Zerhouni, President, mentioned that the trial involves 200 healthy volunteers in different cohorts to test adjuvants. The focus is on tolerability and safety, with immunogenicity measured through biomarkers, providing an idea of potential efficacy.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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