What Exelixis (EXEL) Said on Its Q3 Earnings Call

Key Points

• Exelixis reported solid Q3 results, with revenue of approximately $659 million and U.S. cabozantinib franchise revenue up 11% year over year to $605 million. The company posted GAAP net income of about $218 million and ended the quarter with $1.4 billion in cash and marketable securities.
• Zanzalintinib remains Exelixis’ top development priority, with seven potentially label-enabling trials underway and a March 3, 2027, FDA action date for its colorectal cancer application. The company is also advancing studies in kidney cancer, neuroendocrine tumors, meningioma, lung cancer and other indications.
• CABOMETYX demand continued to strengthen, with its oral TKI market share rising to 49% and prescription volume increasing 13% year over year. Exelixis sees a potential third-line-plus colorectal cancer launch for zanzalintinib as an approximately $1.5 billion U.S. market opportunity.

Exelixis NASDAQ: EXEL reported third-quarter 2026 revenue of approximately $659 million, supported by continued growth in its cabozantinib franchise and progress toward a potential launch of zanzalintinib in colorectal cancer.

Chief Executive Officer Mike Morrissey said the company is positioning zanzalintinib, also called zanza, as its second potential oncology franchise alongside CABOMETYX. He said CABOMETYX’s third-quarter performance reinforced management’s confidence in the product’s long-term growth trajectory, while zanza remains the company’s top research and development priority.

“Zanza is in the spotlight as our next potential franchise opportunity,” Morrissey said, pointing to ongoing pivotal trials and a planned second wave of potential pivotal studies across genitourinary, gastrointestinal and other tumor types.

Third-quarter financial results

Cabozantinib franchise U.S. net product revenue rose about 11% year over year to $605 million during the quarter. CABOMETYX net product revenue totaled $603 million and did not include clinical-trial sales. Chief Financial Officer Chris Senner said clinical-trial sales have historically varied between quarters and are expected to remain uneven.

Global cabozantinib franchise net product revenue, including sales from Exelixis and its partners, increased approximately 11% year over year to $818 million. Total revenue also included about $52 million in royalties from partners Ipsen and Takeda on their cabozantinib sales.

Exelixis reported GAAP net income of approximately $218 million, or $0.85 per diluted share, for the third quarter. Non-GAAP net income was approximately $240 million, or $0.94 per diluted share, excluding about $22 million of stock-based compensation expense net of related tax effects.

Total operating expenses were approximately $390 million, up from $380 million in the second quarter. Senner attributed the sequential increase primarily to higher legal and advisory fees, marketing expenses and cost of goods sold, partially offset by lower license and collaboration costs.

The company ended the quarter with approximately $1.4 billion in cash and marketable securities. During the quarter, it repurchased roughly $250 million of common stock, retiring about 4.5 million shares at an average price of $55.77 per share. About $348 million remained available under the company’s $750 million share-repurchase authorization as of Sept. 30.

Senner said the company updated its full-year gross-to-net deduction estimate to approximately 30%. Third-quarter gross-to-net deductions were approximately 29%, lower than the prior quarter primarily because of lower 340B discounts.

Zanzalintinib development advances

Executive Vice President of Research and Development Dana Aftab said Exelixis has seven ongoing potentially label-enabling zanza trials, which it calls its Wave 1 program. The company is also planning Wave 2 studies designed to explore additional tumor types and combinations with immunotherapies, chemotherapy and other treatment approaches.

The company’s updated Prescription Drug User Fee Act action date for its zanza new drug application based on the STELLAR-303 trial in colorectal cancer is March 3, 2027.

Exelixis said sites are activated and enrolling patients in STELLAR-316, a Phase III study of zanza with and without subcutaneous pembrolizumab in patients with resected stage 2 or 3 colorectal cancer who test positive for molecular residual disease following definitive therapy but have no radiographic evidence of disease.

In kidney cancer, Exelixis expects top-line results from its STELLAR-304 Phase III study in non-clear cell renal cell carcinoma during the first quarter of 2027. The trial compares zanza plus nivolumab with sunitinib. Aftab said the company is approaching a clinical data cutoff, which is driving the timing expectation.

The company also highlighted continued enrollment in its STELLAR-311 trial in neuroendocrine tumors and STELLAR-201 trial in recurrent meningioma. Separately, it initiated enrollment in STELLAR-202, a Phase II study evaluating zanza plus pembrolizumab in squamous non-small cell lung cancer following induction treatment with pembrolizumab and chemotherapy.

Exelixis is also exploring zanza combinations in bladder cancer, including in patients previously treated with enfortumab vedotin and a PD-1 inhibitor, as well as a zanza-docetaxel combination in metastatic castration-resistant prostate cancer. The company said it has begun enrolling a cohort combining zanza with its XB628 bispecific immunotherapy in a Phase I trial.

Aftab additionally announced XL558, a selective somatostatin receptor 2 agonist, as a newly nominated development candidate. Exelixis plans to submit an investigational new drug application for XL558 later in 2026.

CABOMETYX demand remains strong

Executive Vice President of Commercial PJ Haley said CABOMETYX continued to gain demand in renal cell carcinoma and neuroendocrine tumors. In an oral TKI market basket that includes CABOMETYX, lenvatinib, axitinib, sunitinib and pazopanib, CABOMETYX’s total prescription share rose to 49% in the third quarter from 46% a year earlier. Its prescription volume increased 13%, compared with 6% growth for the market basket.

Haley said CABOMETYX remains the leading TKI-plus-immunotherapy combination in renal cell carcinoma through its combination with nivolumab, while it is also the leading oral therapy in the second-line-plus neuroendocrine tumor setting.

In neuroendocrine tumors, CABOMETYX’s second-line-plus new-patient oral market share exceeded 50%, according to Haley. He said the company expects refills to increase as more patients remain on treatment, while its expanded gastrointestinal sales team has activated more than 1,000 unique neuroendocrine tumor prescribers since launch.

Potential colorectal cancer opportunity

Pending regulatory approval, Exelixis sees zanza’s potential third-line-plus colorectal cancer launch as an opportunity to build on its commercial presence in community oncology. Haley estimated the U.S. third-line-plus colorectal cancer setting includes approximately 23,000 patients and represents an approximately $1.5 billion market opportunity using contemporary pricing.

He said roughly 70% of colorectal cancer prescribers overlap with CABOMETYX prescribers, with overlap rising to 90% when co-located addresses are included. Exelixis believes its established community-based commercial capabilities could support a potential zanza launch in the indication.

About Exelixis (NASDAQ:EXEL)

Exelixis, Inc is a biopharmaceutical company focused on discovering, developing, and commercializing medicines for cancer and other serious diseases. The company's research programs center primarily on targeted therapies, including treatments designed to inhibit signaling pathways involved in tumor growth and progression.

Exelixis' lead product is CABOMETYX (cabozantinib), an oral medicine approved in the United States for certain patients with renal cell carcinoma, hepatocellular carcinoma, and differentiated thyroid cancer.

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