Exelixis Gains FDA Acceptance for Cancer Combo, Sees Q4 Sales at $585M
Exelixis received FDA acceptance for its NDA on a zanzalintinib/atezolizumab colorectal cancer therapy after phase 3 data showed a statistically significant survival benefit versus Bayer’s regorafenib. The company’s Q4 sales are forecast at $584.68 million (up 3% year-over-year) with EPS expected at $0.77 (up 40%).
1. FDA Acceptance of Oncology Combo
Exelixis received FDA acceptance for a New Drug Application of its zanzalintinib and atezolizumab combination targeting metastatic colorectal cancer, supported by phase 3 data demonstrating a statistically significant overall survival benefit versus Bayer’s regorafenib.
2. Q4 Financial Projections
Analysts forecast Exelixis’ fourth-quarter sales at $584.68 million, a 3% year-over-year increase, and EPS at $0.77, reflecting 40% growth over $0.55 a year earlier, extending six consecutive beats to consensus estimates.
3. Annual EPS Outlook and Valuation
For fiscal 2025, Exelixis is expected to report a 48% rise in annual EPS to $2.96, while trading at 12x forward earnings and holding a top Zacks Rank #1 (Strong Buy) in the medical-biomedical and genetics industry.