Exelixis executives used the Wells Fargo 21st Annual Healthcare Conference on Tuesday, September 8, 2026, to place zanzalintinib at the center of the company's near-term strategy. Andrew Peters, senior vice president of strategy, and Chris J. Senner, chief financial officer, described 2026 as a transition period in which the company will continue to grow CABOMETYX while investing in zanzalintinib.
The company expects FDA approval of zanzalintinib for colorectal cancer in December 2026 and plans an immediate launch. Management said the STELLAR-303 trial supports an all-comers filing based on the intent-to-treat population, with consistent benefit across subpopulations. The study evaluates a chemotherapy-free, checkpoint-inhibitor-containing combination doublet, and executives said community oncologists showed strong interest because of their familiarity with checkpoint inhibitors. The third-line-plus colorectal cancer market was described as an approximately $1.5 billion opportunity, and management said its goal is to capture as much of that market as possible.
CABOMETYX remains on track for $3 billion in peak sales. The neuroendocrine tumor opportunity was estimated at about $1 billion at contemporary oral pricing levels, and the company reported new-patient market share of about 45% to 47% in that indication. Executives said CABOMETYX guidance was reduced because patient movement in neuroendocrine tumors was slower than expected. They attributed the slower uptake to the indolent nature of the disease, with patients scanned and switched between therapies less frequently than in some other solid tumors, sometimes at intervals longer than every three months.
In renal cell carcinoma, management said non-clear-cell disease represents about 20% of cases. The Phase 3 STELLAR-304 study is evaluating zanzalintinib in non-clear-cell renal cell carcinoma, excluding chromophobe disease, with the objective of establishing level 1 evidence and a standard of care. LITESPARK-033 and LITESPARK-034 are collaborations with Merck combining zanzalintinib with belzutifan in clear-cell renal cell carcinoma, targeting adjuvant and second-line-plus settings. An early-stage Phase 2 trial in meningioma is using response rate as the primary endpoint, with duration of response, progression-free survival and overall survival as secondary endpoints.
CABOMETYX loss of exclusivity is expected on January 1, 2031, with settlements in place with Teva, Cipla and other companies for generic entry on that date. Management viewed Handa Pharmaceuticals' tentative 505(b)(2) approval of a CABOMETYX-like product as minimal commercial risk in the absence of robust randomized clinical data, saying such products have not been commercially successful without clinical data.
Financially, Exelixis reported revenue of $2.44 billion over the last twelve months and a gross profit margin of 96%. Annual research and development spending is targeted at $1 billion or less. From the second quarter of 2023 through the second quarter of 2026, the company repurchased $2.9 billion of shares, retiring about 90 million shares, and left a balance of about $600 million under its current buyback authorization at the end of the second quarter of 2026. The current ratio was 3.46, and InvestingPro assigned a financial health score of 3.92 out of 5, labeled excellent.
The commercial team expansion began in late 2025 and was fully deployed by the end of the first quarter of 2026. Management also referenced a research and development day held in December 2025, noting that such events are held roughly every two years. Business development efforts are focused primarily on gastrointestinal and genitourinary assets.
