Exelixis has a profitable base and a delayed successor

The technology

Exelixis sells one drug family and is trying to build a second. Cabozantinib, an oral kinase inhibitor sold as Cabometyx, brought in $573.0 million in U.S. net product revenue in the second quarter. Its successor, zanzalintinib, is an investigational oral inhibitor of VEGF receptors, MET and the TAM kinases AXL and MER, according to OncLive.

The company has a wide phase 3 program: STELLAR-303 in colorectal cancer, STELLAR-304 in non-clear cell kidney cancer, STELLAR-311 in neuroendocrine tumors, STELLAR-316 in resected colorectal cancer, and two Merck-run LITESPARK trials with Welireg in kidney cancer, all described in the second-quarter release.

The odds

One application is under review. The FDA accepted it in February 2026 for zanzalintinib plus atezolizumab in previously treated metastatic colorectal cancer, and on Sept. 10 it extended the review to March 3, 2027 after treating new data as a major amendment. The supporting trial, STELLAR-303, met its overall survival endpoint in all patients: median 10.9 months against 9.4 months for regorafenib, a hazard ratio of 0.80, per OncLive. It missed its second primary endpoint, in patients without liver metastases.

Published base rates from BIO, Informa and QLS (2011 to 2020) put NDA/BLA to approval at 90.6%. This application is already past the filing step. The base rate does not account for the amendment, the missed subgroup or the safety imbalance: grade 3 or higher treatment-related events ran 60% against 37%, with five treatment-related deaths against one.

For the rest of the program, the nearest test is STELLAR-304, with topline results expected in the second half of 2026. The same study puts phase 3 to filing at 57.8% across all drugs, so the remaining trials carry real failure risk.

The money

Exelixis is profitable. Second-quarter total revenue was $628.7 million and GAAP net income was $212.1 million, per the release. Cash and marketable securities were $1.4 billion at June 30, down from $1.7 billion at the end of 2025. The 10-Q ties the fall in working capital mainly to share repurchases. The company has bought back $2.9 billion of stock since March 2023, and a new $750 million program began in the second quarter.

Guidance for 2026 is $2.500 billion to $2.550 billion in total revenue, cut from $2.525 billion to $2.625 billion, and it excludes any zanzalintinib sales. R&D guidance also came down, to $825 million to $875 million. The 10-Q says cash and revenue should fund operations for at least 12 months and thereafter for the foreseeable future.

The risks

Concentration comes first. All of the company's product revenue today comes from cabozantinib. On Aug. 31 the Federal Circuit upheld three patents that bar final approval of MSN's generic before Jan. 15, 2030, subject to further proceedings. A trial on another patent, which expires in 2032, starts in November 2026. Teva, Cipla, Biocon, Sun and Accord also have generic applications listed in the 10-Q.

Regulatory timing comes second. The delay pushes any zanzalintinib launch into 2027. Third is the safety profile in colorectal cancer, which a reviewer will weigh against a median survival gain of 1.5 months.

Our read

Exelixis is a cash-generating company with one mature product and a late-stage successor that has just run into friction. The colorectal data were enough to get an application accepted. They were not clean enough to avoid a three-month delay, and the subgroup miss narrows the argument for the drug.

What the company has going for it is time and money. Patent protection to at least 2030 on the cabozantinib franchise, if it holds, gives the pipeline several years to deliver. The kidney cancer readout in the second half of 2026 may matter as much to the long-term case as the colorectal decision, because a win would add a second indication. Safety data in each trial deserve close reading, since the colorectal numbers suggest tolerability could limit use.