These are the key contradictions discussed in Exelixis' latest 2024Q4 earnings call, specifically including: Zanza's Positioning and Potential Peak Sales, Label and Positioning of Cabo and Zanza, Zanza's Indication Focus and Market Potential, and Confidence in NET Indications:
Revenue and Growth of Cabozantinib:
- Exelixis reported cabozantinib franchise net product revenues of
$515.2 million for Q4 2024, a
20% year-over-year increase, with global franchise revenues reaching
$690 million in Q4 2024.
- The growth was driven by the strong performance of the CABOMETYX business, maintaining its leading position in the RCC market and expansion in global markets.
Financial Guidance and 2025 Outlook:
- Exelixis provided 2025 financial guidance, projecting continued growth with anticipated zanza data milestones and potential new indictments for cabozantinib.
- The company indicated that updates on net product revenue guidance, including the NET opportunity, will be provided after regulatory approval.
NET Indication and Regulatory Progress:
- The FDA accepted Exelixis's sNDA seeking approval for cabozantinib in pNET and epNET indications with a PDUFA date of April 3, 2025.
- Exelixis is prepared for commercial launch once approval is secured, based on positive results from the CABINET trial.
Pipeline and Business Development:
- Exelixis plans to initiate the STELLAR-311 trial of zanza in NET in the first half of 2025 and anticipates Merck to initiate two RCC studies evaluating zanza.
- The company continues to focus on late-stage assets in the GI/GU space, with a strategy for back-end loaded pay-for-success transactions.
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