Exelixis 2025 R&D Day Summary Company Overview - **Company**: Exelixis (NasdaqGS:EXEL) - **Focus**: Oncology, specifically solid tumor oncology Key Themes and Strategic Focus - **Multi-Compound, Multi-Franchise Strategy**: Exelixis aims to build a diverse pipeline of oncology products rather than focusing on single indications [4][5] - **Franchise Approach**: The company is prioritizing the development of franchise molecules and indications to enhance its market position and revenue potential [5][10] - **Patient-Centric Goals**: The overarching goal is to improve the standard of care for cancer patients, thereby benefiting both patients and shareholders [6][10] Financial Projections and Growth - **CABO Franchise Growth**: Projected cumulative growth of over 30% in CABO product revenues from 2023 to 2025, driven by new indications in the MET space [7] - **Zanza Development**: Zanza is positioned as a key molecule for future growth, with positive results from pivotal trials and an FDA filing based on the STELLAR-303 trial [8][9] Pipeline and Product Development - **Early-Stage Pipeline**: The pipeline includes three IND candidates (XB010, XB628, XB371) and new molecules like XB773 and XL557, which are advancing towards IND status [9] - **Focus Areas**: The company is concentrating on kidney cancer, neuroendocrine tumors, and colorectal cancer as primary targets for its pipeline [14] Clinical Trials and Research - **Ongoing Trials**: Exelixis has multiple ongoing or planned pivotal trials, including STELLAR-304 for non-clear cell renal cell carcinoma (RCC) and LITESPARK-033 for patients progressing after adjuvant Pembrolizumab [35][49] - **Zanza's Mechanism of Action**: Zanza is designed to target multiple pathways (MET, TAM kinases, VEGF) to combat resistance and improve patient outcomes [30][32] Unmet Medical Needs - **Non-Clear Cell RCC**: There is a significant unmet need in treating non-clear cell RCC, which has historically been underrepresented in clinical trials [20][24] - **Adjuvant Treatment Gaps**: The introduction of Pembrolizumab in the adjuvant setting has created a new patient population with unmet needs, which Exelixis aims to address with Zanza and HIF-2 inhibitors [49] Collaboration and Partnerships - **Expert Collaborations**: Exelixis collaborates with leading oncologists and institutions to enhance its research and development efforts, ensuring a strong focus on patient outcomes [60] Conclusion - **Commitment to Oncology**: Exelixis emphasizes its long-term commitment to advancing treatment options in oncology, particularly in renal cell carcinoma, with a focus on innovative therapies and patient care [61]

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]