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    Michael Schmidt • Guggenheim Partners

    Michael Schmidt's questions to Genmab A/S (GMAB) leadership

    Michael Schmidt's questions to Genmab A/S (GMAB) leadership • Q1 2025

    Question

    Paul Jeng, on behalf of Michael Schmidt from Guggenheim Partners, asked about Genmab's confidence in securing regulatory approval for EPKINLY in follicular lymphoma based on the ORR co-primary endpoint and how the drug is expected to compete against a CD19 R2 regimen.

    Answer

    CMO Tahamtan Ahmadi expressed high confidence in the regulatory path, citing the prior breakthrough designation and positive FDA feedback on the totality of the data shared. Regarding competition, he stated that while he could not preview embargoed data, he was confident that competitive positioning would not be a concern once the full dataset becomes public.

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    Michael Schmidt's questions to Beigene Ltd (ONC) leadership

    Michael Schmidt's questions to Beigene Ltd (ONC) leadership • Q4 2024

    Question

    An analyst on behalf of Michael Schmidt at Guggenheim Partners followed up on the CDK4 inhibitor, asking about expectations for the upcoming ASCO data and what efficacy signals would be needed to support further development and differentiation.

    Answer

    CEO John Oyler responded that early data is already showing less hematological toxicity and better target inhibition, consistent with the drug's selective profile. He stated the company will analyze incoming data to inform a decision on initiating a pivotal trial in late 2025 or early 2026.

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