Exelixis (EXEL) investor relations material

Macro environment and innovation

• China-originated innovation is intensifying competition, prompting a focus on novel assets and collaborative opportunities to expand the portfolio, including ex-U.S. assets.

• AI adoption is targeted and data-driven, prioritizing areas with curated, valuable data to enhance speed, quality, and security in commercial and development operations.

• Policy risks such as FDA regulation, Medicare negotiation, MFN, tariffs, and global pricing are closely monitored, with strategic navigation planned through 2028 and beyond.

• Pricing and MFN issues are top concerns, with ongoing engagement in D.C. to influence industry-relevant policy.

Franchise strategy and product pipeline

• Cabozantinib maintains strong global growth, exceeding $3 billion annualized run rate, with ongoing efforts to expand indications and defend exclusivity through 2031.

• Zanzalintinib is positioned as a potential multi-indication franchise, with pivotal trials in CRC, RCC, and NET, aiming to surpass cabozantinib's success.

• The CRC launch for zanzalintinib is delayed by three months but remains a high priority, with sales and analytics teams leveraging AI for launch readiness.

• STELLAR-303 and STELLAR-316 trials in CRC are generating strong market interest, with a $1.5 billion opportunity in third-line plus settings.

• In RCC, STELLAR-304 is the first global pivotal trial in non-clear cell, with additional studies exploring novel combinations, including bispecifics and cancer vaccines.

Early-stage pipeline and capital allocation

• Four phase I programs are advancing toward go/no-go decisions, with a disciplined, data-driven approach to prioritization and termination.

• Internal innovation and BD activities are balanced based on data, with capital allocated to assets showing franchise potential regardless of origin.

• The pipeline includes ADCs, small molecules, and bispecifics, with selective in-house combinations to maximize value.

• The goal is to build a portfolio of franchise molecules, focusing on a few high-value winners rather than a broad but uncertain pipeline.