Exelixis (NASDAQ:EXEL) reported second-quarter 2026 revenue of approximately $629 million, including $573 million in cabozantinib franchise net product revenue, as the company prepared for a potential late-year launch of zanzalintinib in colorectal cancer and advanced a broader development program for the drug candidate.
President and Chief Executive Officer Mike Morrissey said the company is entering its next growth phase as it seeks to build a multi-franchise oncology business beyond cabozantinib, marketed as CABOMETYX. Zanzalintinib, or Zanza, is Exelixis’ highest research and development priority and is under FDA review in combination with atezolizumab for previously treated colorectal cancer.
Cabozantinib Revenue Grows, but Guidance Is Reduced
U.S. cabozantinib franchise net product revenue increased about 10% year over year to $573 million in the second quarter, while global cabozantinib franchise net product revenue, including partner sales, rose about 13% to $806 million, according to Morrissey.
Chief Financial Officer Chris Senner said CABOMETYX net product revenue totaled $571 million, including approximately $2.7 million in clinical trial sales. The company also recorded about $53 million in royalties from partners Ipsen and Takeda related to their cabozantinib sales.
Exelixis lowered and narrowed its full-year 2026 total revenue and net product revenue outlook, reducing the midpoint by $50 million. Senner said the update reflects modestly slower growth due to a more gradual-than-expected ramp in the neuroendocrine tumor, or NET, indication.
The company also reduced its R&D expense guidance, lowering the midpoint of that range by $50 million. Morrissey said Exelixis expects projected free cash flow to remain essentially unchanged as it balances investment in its pivotal trials with expense discipline.
P.J. Haley, executive vice president of commercial, said the slower NET revenue ramp was tied to characteristics of the patient population rather than a change in the company’s long-term view of the market. NET tumors can be more indolent than other solid tumors, and patients may be scanned less frequently, remain on their existing treatment longer, or take treatment breaks before moving to a subsequent therapy.
Despite those dynamics, Haley said CABOMETYX achieved more than 45% of oral second-line-plus new-patient market share in NET during the quarter. He said increasing new-patient share should support refills and future demand.
- CABOMETYX total prescription share in an oral TKI market basket increased to 47% in the second quarter, from 45% a year earlier.
- CABOMETYX prescription volume rose 12% year over year, compared with 6% growth for the overall market basket cited by the company.
- Exelixis said CABOMETYX remains the leading prescribed TKI in renal cell carcinoma and the leading TKI-plus-immunotherapy combination in first-line RCC.
Profitability and Capital Returns
Exelixis reported GAAP net income of approximately $212 million, or $0.82 per diluted share, for the second quarter. The company reported non-GAAP net income of approximately $237 million, or $0.91 per diluted share, excluding roughly $25 million of stock-based compensation net of related tax effects.
Operating expenses totaled approximately $380 million, up from $359 million in the first quarter. Senner attributed the sequential increase primarily to higher clinical trial costs, marketing expenses and stock-based compensation.
Cash and marketable securities totaled approximately $1.4 billion as of June 30. During the quarter, Exelixis repurchased approximately $312 million of common stock, retiring about 6.5 million shares at an average price of $47.85 per share. The company completed its October 2025 repurchase program and had approximately $598 million remaining under a $750 million authorization approved in May 2026.
Zanza Program Advances Across Multiple Tumor Types
Dana Aftab, executive vice president of research and development, said Exelixis has seven ongoing or imminent pivotal studies for Zanza. The company expects top-line results from STELLAR-304, a phase III trial of Zanza plus nivolumab versus sunitinib in locally advanced or metastatic non-clear cell renal cell carcinoma, in the second half of 2026.
Exelixis completed enrollment in STELLAR-304 last year. Aftab said the study is the first large, global randomized phase III trial focused on non-clear cell RCC, which represents approximately 20% of RCC cases. Positive results could support the company’s second new drug application for Zanza, she said.
The company is also preparing to begin screening patients this month in STELLAR-316, a trial in resected stage II or III colorectal cancer patients who test positive for molecular residual disease after definitive therapy but have no radiographic evidence of disease. The study will evaluate Zanza with and without subcutaneous pembrolizumab.
In NET, the STELLAR-311 phase III trial is comparing Zanza with everolimus as an initial oral therapy in pancreatic or extrapancreatic NET. Aftab said enrollment is running months ahead of projections.
Other development efforts include Merck-led phase III trials evaluating Zanza plus belzutifan in clear-cell RCC, an expansion cohort in metastatic bladder cancer after progression on enfortumab vedotin plus pembrolizumab, and a cohort studying Zanza with docetaxel in metastatic castration-resistant prostate cancer.
Exelixis also said enrollment in its phase II STELLAR-201 study in recurrent meningioma is exceeding initial projections. The trial is enrolling up to 100 patients who have progressed after, or are no longer eligible for, local therapies. The company is designing a confirmatory phase III study while the phase II trial continues.
In addition, Exelixis expects to initiate STELLAR-202 in the second half of 2026. The phase II study will evaluate Zanza during maintenance therapy following pembrolizumab plus chemotherapy induction in squamous non-small cell lung cancer.
Regulatory Review Remains Central Focus
During the question-and-answer session, executives declined to discuss potential label language for the colorectal cancer application while the FDA review remains ongoing. Aftab said the company views the application as potentially significant because, if approved, it would provide an immunotherapy-containing regimen for a broad population of patients with third-line-plus colorectal cancer.
Haley estimated the U.S. third-line-plus colorectal cancer setting includes approximately 23,000 patients and represents a $1.5 billion opportunity at contemporary pricing. He said physicians and advisory boards have expressed interest in the STELLAR-303 data and in the potential availability of an immune checkpoint inhibitor-containing regimen for the broader colorectal cancer population.
Morrissey said Exelixis continues to evaluate options for partnering Zanza outside the U.S., noting that the company has received interest but has not made a decision.
About Exelixis (NASDAQ:EXEL)
Exelixis, Inc is a biotechnology company specializing in the discovery, development and commercialization of small molecule therapies primarily for the treatment of cancer. Building on a platform that leverages model organism genetics and high-throughput screening, the company focuses its research on kinase inhibitors that modulate critical signaling pathways involved in tumor growth and metastasis. Exelixis’s translational research approach aims to advance novel compounds from early-stage discovery through clinical development and regulatory approval.
The company’s most recognized products include CABOMETYX® (cabozantinib), approved for the treatment of advanced renal cell carcinoma and hepatocellular carcinoma, and COMETRIQ® (cabozantinib) for metastatic medullary thyroid cancer.
