Exelixis (EXEL) investor relations material

Strategic vision and franchise development

• Transitioning from a single product focus to a franchise model, leveraging learnings from prior drug development to inform new strategies for Zanza across multiple tumor types.

• Emphasis on defining new standards of care in oncology by targeting areas of high unmet need and large market opportunities, particularly in renal cell carcinoma (RCC) and colorectal cancer.

• Franchise approach includes broad investment in each molecule and tumor type, with a focus on capital efficiency and collaborative pivotal studies with industry partners.

• Applying the "Cabo lens" to Zanza, prioritizing studies with high probability of success, robust trial design, and meaningful clinical endpoints.

• Long-term goal is to establish Zanza as the TKI of choice for the 2030s, with ongoing trials aimed at capturing evolving standards of care.

Clinical development and market opportunities

• Multiple ongoing studies in RCC, including first-line, post-pembrolizumab, and non-clear cell settings, targeting a combined market opportunity exceeding $2 billion.

• Focus on rational combinations and novel mechanisms, with flexibility between doublet and triplet regimens based on emerging biology and data.

• STELLAR-304 and STELLAR-316 studies aim to define new standards of care in non-clear cell RCC and ctDNA-positive populations, respectively.

• New diagnostic modalities like Signatera are expanding patient populations and creating new commercial opportunities, estimated at around 12,000 patients for certain indications.

• Ongoing evaluation of emerging targets and modalities, with optimism about future combination strategies for Zanza.

Commercial strategy and capital allocation

• Share buybacks continue as part of a balanced capital allocation strategy, alongside R&D and business development, reflecting a belief in undervaluation due to underappreciated pipeline potential.

• Commitment to R&D spending of $1 billion or less, with ongoing evaluation of external business development and M&A opportunities.

• Expectation that as second-line use of existing therapies declines, first-line uptake will offset revenue impact, with frontline markets offering longer duration and higher revenue potential.

• Anticipation that Zanza’s phase III readouts before the end of the decade will drive uptake and potentially enable growth through the loss of exclusivity (LOE) for Cabo.

• Internal discussions continue regarding future commercial outlook disclosures, with flexibility to provide guidance if market conditions warrant.