Exelixis (EXEL) investor relations material

Key conference insights

• Discussion centered on recent ASCO GU data, particularly LITESPARK-011 results in RCC, highlighting PFS benefit but no significant OS improvement at interim analysis.

• Sequential treatment approaches in RCC may offer similar or better outcomes compared to combination regimens, with notable adverse event profiles influencing clinical decisions.

• Incremental use of CABOMETYX-NIVO in first-line RCC is anticipated if lenvatinib/belzutifan is adopted in second-line, with limited enthusiasm for the new data due to lack of robust survival benefit.

• Quality of life and toxicity, especially hypoxia and cardiac dysfunction, are key considerations in regimen selection, with monotherapy breaks valued by clinicians and patients.

• Collaboration with Merck is advancing, with LITESPARK-033 and a second phase III trial planned to address evolving RCC treatment paradigms and future patient populations.

Pipeline and trial updates

• LITESPARK-033 aims to define future standards for post-adjuvant pembrolizumab RCC, anticipating a higher proportion of such patients by 2030.

• STELLAR-304 is the first large randomized trial in frontline non-clear cell RCC, targeting to establish a new standard of care with ZANZALINTINIB and Nivolumab.

• ZANZALINTINIB's improved pharmacokinetic profile over CABOMETYX, especially its shorter half-life, is expected to enhance titratability and patient management.

• STELLAR-303 in CRC showed a survival advantage for ZANZALINTINIB plus Atezolizumab, with robust benefit across liver and non-liver metastasis subgroups.

• Final OS analysis for non-liver mets CRC patients is expected mid-2026, with hopes for positive results to support broad adoption.

Financial outlook and growth drivers

• 2026 guidance projects 10%-12% year-over-year growth, driven by continued momentum in RCC and expansion in the MET business.

• Anticipated product launches and positive pivotal trial results are expected to support future revenue growth.