Exelixis(US:EXEL) Businesswire·2026-01-11 21:00Core Viewpoint - Exelixis anticipates significant clinical, regulatory, and commercial progress in 2026, focusing on expanding its cabozantinib business and developing zanzalintinib as a potential second commercial franchise while advancing its earlier-stage pipeline [1][19]. Financial Results and Guidance - Preliminary total revenues for fiscal year 2025 are approximately $2.320 billion, with guidance for fiscal year 2026 set between $2.525 billion and $2.625 billion [3]. - Net product revenues for fiscal year 2025 are approximately $2.123 billion, with guidance for fiscal year 2026 ranging from $2.325 billion to $2.425 billion [3]. - Cost of goods sold as a percentage of net product revenues is approximately 3.7% for 2025, with a projected range of 3.5% to 4.5% for 2026 [3]. - Research and development expenses for 2025 are approximately $825 million, with guidance for 2026 set between $875 million and $925 million [3]. - Selling, general, and administrative expenses for 2025 are approximately $520 million, with guidance for 2026 ranging from $575 million to $625 million [3]. - The effective tax rate for 2026 is projected to be between 21% and 23% [3]. Business Updates - The company is focused on leveraging its diverse pipeline and key clinical collaborations to build next-generation oncology franchises aimed at improving cancer care standards [1][6]. - Exelixis expects continued growth in its cabozantinib franchise, which is the leading tyrosine kinase inhibitor in renal cell carcinoma and neuroendocrine tumors [7]. - The company achieved major milestones with zanzalintinib, including a positive pivotal data readout and a U.S. regulatory filing for its use in metastatic colorectal cancer [6][8]. Regulatory and Clinical Milestones - The FDA is currently reviewing Exelixis' New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer [2][8]. - The STELLAR-303 trial for zanzalintinib has shown a statistically significant reduction in the risk of death compared to regorafenib, with further analyses expected in mid-2026 [8][9]. - The STELLAR-304 trial is evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated advanced non-clear cell renal cell carcinoma, with results anticipated in mid-2026 [10]. Pipeline Development - Exelixis is advancing several phase 1 clinical trials for new molecules, including XL309, XB010, XB628, and XB371, with plans to progress them into full development if data are supportive [12]. - The company anticipates initiating two new IND applications in 2026, further expanding its oncology pipeline [13]. Stock Repurchase Program - Exelixis has repurchased a total of $2.16 billion of its common stock since March 2023, with an additional $750 million authorized for repurchase before December 31, 2026 [15].