Exelixis (EXEL) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Strategic priorities and CABO

• Strategic transition: CABO is positioned as the TKI of choice in the 2020s, with zanza targeted to become the TKI of choice in the 2030s; seven pivotal zanza studies are ongoing or have read out.

• CABO volume growth was cited at 13% in Q3; continued RCC share gains and NET launch execution are supported by commercial focus, community outreach and prescriber targeting.

• CABO growth is broad across RCC and NETs; it remains the number-one TKI in RCC, with strong share in NETs.

• 505(b)(2) oncology products generally have not achieved broad commercial uptake without meaningful clinical data; adoption can be constrained by non-AB rating, lack of substitutability and limited guideline inclusion.

Zanza in colorectal cancer

• STELLAR-303 met its OS outcome in the full CRC population; FDA review was extended to March 3, 2027, after the agency requested data and said it needed more review time.

• Clinical interest is supported by a chemo-free, checkpoint-containing option and consistent activity across patient subgroups, including prior Bev and liver-metastasis status.

• ITT results indicate zanza plus atezo benefit regardless of liver-metastasis status; the original hypothesis of differentiated biology in non-liver-metastasis patients was not borne out.

• Phase II/III study 316 will test zanza or zanza plus pembro in high-risk, MRD-positive CRC patients; the cited population is 12,000–13,000, with potential expansion as Signatera/MRD testing grows.

• Earlier-line development follows later-line OS evidence; zanza’s shorter half-life and combinability are cited as potential advantages for patients.

Pipeline, indications and study timing

• STELLAR-304 timing is guided by PFS event accrual; the study was approaching clinical cutoff with a 1Q readout expected. Response rates are co-primary, while PFS triggers the primary analysis.

• RCC plans include post-adjuvant and later-line settings; wave two may explore frontline metastatic disease following the LITESPARK-012 triplet study failure.

• STELLAR-311 compares zanza with everolimus in NETs; the goal is to establish zanza as a TKI of choice for NET patients in the 2030s.

• Meningioma development targets an unmet-need setting; robust activity and duration could support a sizable market opportunity.

• Wave-two investment will prioritize patient need, commercial potential and probability of establishing a new standard of care; a phase II study is underway in bladder cancer after PADCEV, with pivotal development contingent on continued positive data.