Financial Data and Key Metrics Changes - For Q4 2025, total revenues were approximately $599 million, with cabozantinib franchise net product revenues of $546.6 million, and CABOMETYX net product revenues at $544.7 million [15][18] - Gross-to-net for the cabozantinib franchise in Q4 2025 was 28.5%, lower than the previous quarter, primarily due to lower PHS and 340B volume [15][16] - GAAP net income for Q4 2025 was approximately $244.5 million, or $0.92 per share basic, and $0.88 per share diluted [17] - Non-GAAP net income was approximately $259.5 million, or $0.97 per share basic, and $0.94 per share diluted [18] - Cash and marketable securities at year-end 2025 were approximately $1.66 billion, with $954 million spent on share repurchases during the fiscal year [18][19] Business Line Data and Key Metrics Changes - The cabozantinib business maintained strong performance, with U.S. CABO franchise net product revenues growing 17% to approximately $2.12 billion for the full year 2025 [10] - CABOMETYX continued to be the leading TKI for renal cell carcinoma (RCC) and the market leader for neuroendocrine tumors in the oral second-line-plus segment [20] - CABOMETYX TRX volume grew 15% in Q4 2025 compared to Q4 2024, outpacing the market basket growth rate of 7% [21] Market Data and Key Metrics Changes - CABOMETYX's market share in the oral TKI market increased from 43% to 46% from Q4 2024 to Q4 2025 [20] - CABOMETYX revenue in neuroendocrine tumors exceeded $100 million in 2025, indicating strong market demand [23] Company Strategy and Development Direction - The company aims to build a multi-franchise business in solid tumor oncology, focusing on cabozantinib and zanzalintinib, with a strategy that encompasses products, tumor indications, and modalities [8][9] - The company is preparing for the potential launch of zanzalintinib in colorectal cancer (CRC) and has expedited the build-out of its GI sales team to support this initiative [11][23] - Business development activities are focused on late-stage assets in GU and GI spaces, with an emphasis on pay-for-success transactions [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2026 being a transformational year, with expectations for continued growth in cabozantinib and the potential launch of zanzalintinib [35] - The company is actively engaging with regulators regarding the NDA for zanzalintinib, with a PDUFA target action date set for December 3, 2026 [26][28] Other Important Information - The company reported a sequential increase in operating expenses due to higher manufacturing costs, NDA filing fees, and personnel expenses [16][17] - The company has approximately $590 million remaining under its stock repurchase plan authorized in October 2025 [19] Q&A Session Summary Question: Duration of small manufacturer discount for Zanza and share repurchase cadence - Management indicated that the small manufacturer exemptions are tied to having a single product as the majority revenue source, which is expected to remain for the foreseeable future [39] - Share repurchases will continue as long as the company feels undervalued, with a commitment to complete the remaining authorization this year [40] Question: 340B purchasing behavior and Part D redesign impact - Management noted variability in 340B purchasing behavior and expects this to continue, which could impact gross-to-net [42] - The company plans to optimize its channel for Zanza based on experiences from cabozantinib [44] Question: STELLAR-316 population size and timeline - The estimated population for STELLAR-316 is around 20,000-25,000 patients who are MRD positive after definitive therapy [47] Question: Revenue potential for NET and market dynamics - Management expressed confidence in the growth potential for neuroendocrine tumors, emphasizing the importance of community outreach and the expansion of the GI sales team [51] Question: Non-clear cell RCC market size and outcomes - Non-clear cell RCC represents approximately 20% of RCC, and the company is optimistic about the potential benefits of its pivotal study in this underserved population [82]

Strategy and Vision - Exelixis aims to become a top 5 solid tumor oncology company by building next-generation oncology franchises across products, modalities, and tumors[8, 12] - The company plans to maintain focus on solid tumors and select modalities to maximize R&D productivity and build product, modality, and tumor franchises[13] - Exelixis anticipates sustained revenue growth through 2031 and beyond by establishing, expanding, and entrenching leadership in key tumors[5, 13] Financial Performance and Growth - Net product revenues are projected to grow from $1.63 billion in FY 2023 to approximately $2.10-$2.15 billion in FY 2025[9] - The 3L+ mCRC market is approaching $1.5 billion in 2026, representing a significant opportunity for zanzalintinib[102] - The CRC market is expected to grow from approximately $3.4 billion in 2024 to $7 billion in 2035, with a compound annual growth rate (CAGR) of 6.6%[123] Pipeline Development and Clinical Trials - Zanzalintinib's phase 3 trial (STELLAR-303) met its primary endpoint, supporting its first NDA filing[9] - Multiple zanzalintinib pivotal trials have been initiated or are planned, including two phase 3 studies in RCC in collaboration with Merck[5, 9] - STELLAR-303 trial data showed median OS of 10.9 months for Zanzalintinib + Atezolizumab arm vs 9.4 months for Regorafenib arm, with HR of 0.80 (95% CI, 0.69–0.93); P=0.0045[93] Key Product Candidates and Franchises - The company is focusing on RCC, neuroendocrine, and CRC franchises as core to its portfolio strategy[24] - XB628, a novel NKG2A x PD-L1 bispecific antibody, is in Phase 1 clinical trials with potential in IO sensitive and insensitive tumors[10, 65] - XL557, an oral SSTR2 agonist, has the potential to broadly displace SSAs in NET, with branded SSAs generating approximately $1.1 billion in U.S sales in 2024[10, 140]