Exelixis(US:EXEL)2026-01-12 21:22Financial Performance - Exelixis reported preliminary U.S. net product revenues of approximately $2.123 billion for fiscal year 2025[1]. - The company provided fiscal year 2026 net product revenues guidance of $2.325 billion to $2.425 billion[2]. - Total revenues for fiscal year 2025 are estimated at around $2.320 billion, with guidance for 2026 set at $2.525 billion to $2.625 billion[4]. - The effective tax rate for fiscal year 2026 is projected to be between 21% and 23%[4]. - Exelixis' preliminary financial results for FY 2025 are being finalized, with the company cautioning that these results are based on preliminary information and may differ from audited results[22]. Research and Development - Research and development expenses for fiscal year 2025 are approximately $825 million, with guidance for 2026 ranging from $875 million to $925 million[4]. - Exelixis anticipates continued growth in the cabozantinib franchise, which is the leading tyrosine kinase inhibitor in renal cell carcinoma and neuroendocrine tumors[8]. - The company expects to initiate the STELLAR-316 trial in mid-2026, evaluating zanzalintinib in patients with resected stage II/III colorectal cancer[14]. - Exelixis plans to advance two programs into clinical development in 2026, including LITESPARK-033 and STELLAR-201[14]. - The company is progressing XL309, XB010, XB628, and XB371 into full development as part of its strategy to build next-generation oncology franchises[21]. - The company is focused on advancing its pipeline, including the clinical development of XL557 and XB773, contingent on supportive phase 1 data[21]. Commercial Strategy - Exelixis anticipates 2026 to be a significant year for clinical, regulatory, and commercial progress, focusing on expanding its cabozantinib business and developing zanzalintinib[20]. - The company aims to establish lasting franchises in renal cell carcinoma (RCC), neuroendocrine tumors (NET), and colorectal cancer (CRC), while driving sustained growth and returning capital to shareholders[20]. - Exelixis expects continued strong commercial performance of cabozantinib, with anticipated growth in RCC and NET in 2026, including plans to expand its gastrointestinal (GI) sales team[20]. - The regulatory review process for zanzalintinib's NDA for previously metastatic CRC in combination with atezolizumab is underway, with potential first commercial launch planned[20]. - Exelixis plans to initiate several pivotal trials, including STELLAR-316 and STELLAR-301, in 2026, and expects clinical data readouts from STELLAR-303 and STELLAR-304[20]. - The company emphasizes the importance of maintaining adequate sales, marketing, and distribution capabilities for its products to ensure market acceptance[21]. Shareholder Returns - Exelixis has repurchased a total of $2.16 billion of its common stock since March 2023, retiring 76.7 million shares[16].