EXEL Q4 Earnings and Revenues Beat, Colorectal Cancer Drug in Focus

Exelixis, Inc. EXEL reported better-than-expected results for the fourth quarter of 2025.

Adjusted earnings per share (EPS) of 94 cents comfortably beat the Zacks Consensus Estimate of 77 cents. The company posted adjusted EPS of 55 cents in the year-ago quarter. Adjusted earnings exclude the impact of stock-based compensation expenses.

Including stock-based compensation expense, EPS was 88 cents compared with 48 cents in the year-ago period.

The bottom-line growth benefited from lower operating expenses and a decrease in shares outstanding due to ongoing buybacks.

Net revenues of $598.7 million beat the Zacks Consensus Estimate of $585 million. The top line was up 5.6% year over year.

However, the stock is down in pre-market trading in response to the fourth-quarter results. Over the past year, Exelixis’ shares have risen 31% compared with the industry’s gain of 20.3%.

EXEL’s Q4 Results in Detail

The year-over-year growth in revenues can be attributed to higher product sales.

Net product revenues were $546.6 million, up 6% year over year, driven by increased sales volume.

Cabometyx (cabozantinib) generated revenues of $544.7 million, which missed the Zacks Consensus Estimate of $554 million but marginally beat our model estimate of $544 million. The drug is approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma.

In March 2025, Exelixis obtained FDA approval for the label expansion of Cabometyx for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors (pNET). The drug was also approved for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET).  

Cometriq (cabozantinib capsules) generated $1.8 million in net product revenues for treating medullary thyroid cancer.  

Collaboration revenues, comprising license and collaboration services revenues, totaled $52.1 million, up 1% year over year. The increase was primarily related to higher royalty revenues for the sales of cabozantinib outside the country generated by Exelixis’ collaboration partner Ipsen Pharma.

Research and development expenses (including stock-based compensation) amounted to $213.2 million, down 14.4% year over year. The decline was primarily related to a decrease in clinical trial costs and license and other collaboration costs.

Selling, general and administrative expenses totaled $123 million, down 8% year over year, primarily due to decreases in stock-based compensation and personnel expenses.

During the quarter, Exelixis repurchased $264.5 million shares, completing the $500 million share repurchase program (SRP) authorized in February 2025.

Since the board approved its first SRP in March 2023, the company has repurchased $2.16 billion of its common stock.

In October 2025, the board authorized an additional $750 million SRP through Dec. 31, 2026, with buybacks beginning in the fourth quarter of 2025.

EXEL’s 2025 Results

The company reported revenues of approximately $2.32 billion for 2025, in line with the preliminary results reported last month. The figure was up 7% from the 2024 level.

Adjusted EPS of $3.08 was up from $2 in 2024. The figure beat the Zacks Consensus Estimate of $2.96.

EXEL’s 2026 Guidance

Exelixis has reiterated its guidance for 2026 (provided last month). The company expects total revenues of $2.525-$2.625 billion in 2026. Net product revenues are projected to be in the range of $2.325-$2.425 billion.

Exelixis’ 2026 net product revenue guidance includes a 3.0% increase in wholesale acquisition costs for Cabometyx and Cometriq in the United States, effective Jan. 1, 2026.

The annual guidance excludes any contribution from a potential approval of zanzalintinib in metastatic colorectal cancer (CRC).

Operating expenses are projected to increase. The company expects R&D expenses of $875-$925 million and SG&A expenses of $575-$625 million.

Key Pipeline and Regulatory Updates From EXEL

The company is developing zanzalintinib, a next-generation oral investigational tyrosine kinase inhibitor (TKI).

Earlier this month, the FDA accepted EXEL’s NDA seeking approval of zanzalintinib in previously treated metastatic CRC — in combination with Roche’s RHHBY Tecentriq (atezolizumab). The regulatory body assigned a target action date of Dec. 3, 2026.

The NDA is supported by positive phase III STELLAR-303 data demonstrating a statistically significant reduction in the risk of death compared with Stivarga (regorafenib).

Roche’s Tecentriq is a cancer immunotherapy that is approved around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various types of cancer.

Exelixis is gearing up for the potential first commercial launch of zanzalintinib for the above-mentioned indication.  

Last month, EXEL announced a collaboration with Natera NTRA for the STELLAR-316 study. This phase III study is being sponsored by Exelixis. The study will evaluate zanzalintinib, with and without an immune checkpoint inhibitor, in patients with resected stage II/III colorectal cancer (CRC).

Patients with CRC who are molecular residual disease (MRD)-positive based on Natera’s Signatera test following completion of definitive therapy — and who have no radiographic evidence of disease — will be eligible for enrollment in the STELLAR-316 trial. Exelixis expects to initiate this study in mid-2026.

Exelixis also collaborated with pharma giant Merck MRK in October 2024 to advance zanzalintinib.

In December 2025, MRK launched LITESPARK-033 — the first of two planned Merck-sponsored pivotal studies evaluating zanzalintinib in combination with belzutifan for RCC. The trial is assessing the combination versus cabozantinib as a first-line treatment for advanced RCC in patients who had previously received adjuvant immunotherapy. Merck plans to disclose details of the second pivotal study in the future.

Zanzalintinib is currently being evaluated for the treatment of advanced solid tumors, including CRC, kidney cancer and neuroendocrine tumors.

A phase III study, STELLAR-304, is evaluating zanzalintinib in combination with Opdivo (nivolumab) versus Sutent (sunitinib) in previously untreated patients with advanced non-clear cell RCC. Top-line results are expected in mid-2026, based on current event rates.

Beyond zanzalintinib, Exelixis is advancing several phase I assets across small molecules, bispecific antibodies and ADCs.

EXEL has two new investigational new drug (IND) filings planned in 2026 – XL557 and XB773. XL557 is an orally bioavailable small molecule somatostatin receptor 2 agonist for NET. XB773 is an antibody-drug conjugate (ADC) consisting of an exatecan payload conjugated to a monoclonal antibody targeting DLL3, a transmembrane protein that is expressed in neuroendocrine carcinomas, such as small cell lung cancer and neuroendocrine prostate cancer.

Our Take on EXEL’s Performance

EXEL’s overall performance in the fourth quarter was encouraging, with a beat in both earnings and sales. Cabometyx holds a dominant position as the leading TKI monotherapy for RCC and as the market leader in neuroendocrine tumors in the oral second-line-plus segment.

Exelixis, Inc. Price, Consensus and EPS Surprise

Exelixis, Inc. price-consensus-eps-surprise-chart | Exelixis, Inc. Quote

Cabometyx total prescriptions rose 15% in the fourth quarter, outpacing the broader market basket’s 7% growth over the same period.

The strong uptake of Cabometyx in the recently approved NET indication is encouraging and should fuel sales.

Zanzalintinib represents the company’s most significant near-term catalyst. A potential approval of the candidate will be a significant boost for EXEL’s oncology pipeline. Management is expanding gastrointestinal sales infrastructure to support further growth in NET and prepare for potential oncology indications for zanzalintinib.

The successful development of additional drugs should broaden the company’s portfolio and reduce dependence on its lead drug, Cabometyx.

EXEL’s Zacks Rank

Exelixis currently carries a Zacks Rank #2 (Buy).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

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This article originally published on Zacks Investment Research (zacks.com).

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