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EXEL advances zanzalintinib with FDA NDA acceptance and multiple late-stage trials underway.
Exelixis, Inc. (EXEL - Free Report) reported mixed results for the first quarter of 2026.
Adjusted earnings per share (EPS) of 87 cents comfortably beat the Zacks Consensus Estimate of 75 cents. The company posted adjusted EPS of 62 cents in the year-ago quarter. Adjusted earnings exclude the impact of stock-based compensation expenses.
Including stock-based compensation expense, EPS was 79 cents compared with 55 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 $611 million missed the Zacks Consensus Estimate of $613 million. The top line was up 10% year over year.
The stock is up in pre-market trading in response to the first-quarter results.
Year to date, Exelixis’ shares have risen 1.3% against the industry’s decline of 2.4%.
Image Source: Zacks Investment Research
EXEL’s Q1 Results in Detail
Net product revenues of $555.0 million were up from $513.3 million in the year-ago quarter. Management attributed the increase to higher sales volume.
Cabometyx (cabozantinib) generated revenues of $552.8 million, which missed the Zacks Consensus Estimate of $558 million and our model estimate of $564 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 $2.2 million in net product revenues for treating medullary thyroid cancer.
Collaboration revenues, comprising license and collaboration services revenues, totaled $55.8 million, up 32.4% year over year. The improvement reflected higher royalty revenues from ex-U.S. cabozantinib sales generated by Ipsen and higher milestone-related revenues recognized during the period.
Research and development expenses amounted to $199.9 million, down from $212.2 million in the prior-year quarter due to lower clinical trial and manufacturing costs.
Selling, general and administrative expenses totaled $139.6 million, up 1.8% year over year, primarily due to increases in marketing activities, legal and advisory fees, and personnel expenses.
As of the end of the first quarter of 2026, Exelixis repurchased $590.6 million of its shares under the $750 million share repurchase program (SRP) authorized in October 2025. The company expects to complete the remaining portion of this program in May 2026, ahead of its original commitment to finish by Dec. 31, 2026.
Since initiating its first SRP in March 2023, Exelixis has repurchased a total of $2.59 billion of its common stock, retiring 86.8 million shares at an average price of $29.86 per share as of quarter-end.
In May 2026, the company’s board of directors approved a new $750 million SRP, with authorization extending through Dec. 31, 2027. This marks the sixth SRP launched since March 2023.
EXEL Reaffirms 2026 Guidance
Exelixis has reiterated its guidance for 2026. 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).
In February 2026, the FDA accepted EXEL’s new drug application seeking approval of zanzalintinib in previously treated metastatic CRC — in combination with Roche’s (RHHBY - Free Report) 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.
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 the second half of 2026, based on current event rates.
Earlier this year, Exelixis collaborated with Natera (NTRA - Free Report) 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 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 - Free Report) in October 2024 to advance zanzalintinib.
In April 2026, MRK initiated LITESPARK-034, a phase II trial evaluating zanzalintinib plus Welireg (belzutifan) versus Welireg and placebo in previously treated advanced RCC patients who progressed after PD-1/L1 and VEGFR-TKI therapies.
This marks the second Merck-sponsored phase III study under the collaboration, following LITESPARK-033 (launched in December 2025), which is assessing the combination against cabozantinib in first-line advanced RCC post-adjuvant immunotherapy.
Exelixis also announced two additional studies of zanzalintinib — STELLAR-202, a planned phase II trial evaluating the drug in combination with MRK’s blockbuster drug Keytruda (pembrolizumab) as maintenance therapy in squamous non-small cell lung cancer, and a new expansion cohort in the ongoing phase Ib/II STELLAR-002 study assessing zanzalintinib plus docetaxel in metastatic castration-resistant prostate cancer patients with measurable disease. Exelixis plans to launch STELLAR-202 and open the STELLAR-002 expansion cohort in the second half of 2026.
Our Take on EXEL’s Q1 Performance
While the narrow revenue miss in the first quarter was disappointing, EXEL’s overall performance has been encouraging.
The Cabometyx franchise continued to gain momentum in 2026, maintaining its position as the leading prescribed TKI in renal cell carcinoma, the top TKI plus immunotherapy combination in first-line RCC, and the leading oral option in second-line and later neuroendocrine tumors. First-quarter results reflected strong performance, with a record number of new patient starts and the highest-ever first-line RCC market share for Cabometyx plus Opdivo.
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 completed the expansion of its gastrointestinal sales team to support cabozantinib momentum in neuroendocrine tumors and prepare for potential zanzalintinib indications.
The successful development of additional drugs should broaden the company’s portfolio and reduce dependence on its lead drug, Cabometyx.
View the Zacks #1 Rank List
Image: Bigstock
EXEL Q1 Earnings Top Estimates, Colorectal Cancer Drug in Focus
Key Takeaways
Exelixis, Inc. (EXEL - Free Report) reported mixed results for the first quarter of 2026.
Adjusted earnings per share (EPS) of 87 cents comfortably beat the Zacks Consensus Estimate of 75 cents. The company posted adjusted EPS of 62 cents in the year-ago quarter. Adjusted earnings exclude the impact of stock-based compensation expenses.
Including stock-based compensation expense, EPS was 79 cents compared with 55 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 $611 million missed the Zacks Consensus Estimate of $613 million. The top line was up 10% year over year.
The stock is up in pre-market trading in response to the first-quarter results.
Year to date, Exelixis’ shares have risen 1.3% against the industry’s decline of 2.4%.
Image Source: Zacks Investment Research
EXEL’s Q1 Results in Detail
Net product revenues of $555.0 million were up from $513.3 million in the year-ago quarter. Management attributed the increase to higher sales volume.
Cabometyx (cabozantinib) generated revenues of $552.8 million, which missed the Zacks Consensus Estimate of $558 million and our model estimate of $564 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 $2.2 million in net product revenues for treating medullary thyroid cancer.
Collaboration revenues, comprising license and collaboration services revenues, totaled $55.8 million, up 32.4% year over year. The improvement reflected higher royalty revenues from ex-U.S. cabozantinib sales generated by Ipsen and higher milestone-related revenues recognized during the period.
Research and development expenses amounted to $199.9 million, down from $212.2 million in the prior-year quarter due to lower clinical trial and manufacturing costs.
Selling, general and administrative expenses totaled $139.6 million, up 1.8% year over year, primarily due to increases in marketing activities, legal and advisory fees, and personnel expenses.
As of the end of the first quarter of 2026, Exelixis repurchased $590.6 million of its shares under the $750 million share repurchase program (SRP) authorized in October 2025. The company expects to complete the remaining portion of this program in May 2026, ahead of its original commitment to finish by Dec. 31, 2026.
Since initiating its first SRP in March 2023, Exelixis has repurchased a total of $2.59 billion of its common stock, retiring 86.8 million shares at an average price of $29.86 per share as of quarter-end.
In May 2026, the company’s board of directors approved a new $750 million SRP, with authorization extending through Dec. 31, 2027. This marks the sixth SRP launched since March 2023.
EXEL Reaffirms 2026 Guidance
Exelixis has reiterated its guidance for 2026. 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).
In February 2026, the FDA accepted EXEL’s new drug application seeking approval of zanzalintinib in previously treated metastatic CRC — in combination with Roche’s (RHHBY - Free Report) 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.
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 the second half of 2026, based on current event rates.
Earlier this year, Exelixis collaborated with Natera (NTRA - Free Report) 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 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 - Free Report) in October 2024 to advance zanzalintinib.
In April 2026, MRK initiated LITESPARK-034, a phase II trial evaluating zanzalintinib plus Welireg (belzutifan) versus Welireg and placebo in previously treated advanced RCC patients who progressed after PD-1/L1 and VEGFR-TKI therapies.
This marks the second Merck-sponsored phase III study under the collaboration, following LITESPARK-033 (launched in December 2025), which is assessing the combination against cabozantinib in first-line advanced RCC post-adjuvant immunotherapy.
Exelixis also announced two additional studies of zanzalintinib — STELLAR-202, a planned phase II trial evaluating the drug in combination with MRK’s blockbuster drug Keytruda (pembrolizumab) as maintenance therapy in squamous non-small cell lung cancer, and a new expansion cohort in the ongoing phase Ib/II STELLAR-002 study assessing zanzalintinib plus docetaxel in metastatic castration-resistant prostate cancer patients with measurable disease. Exelixis plans to launch STELLAR-202 and open the STELLAR-002 expansion cohort in the second half of 2026.
Our Take on EXEL’s Q1 Performance
While the narrow revenue miss in the first quarter was disappointing, EXEL’s overall performance has been encouraging.
Exelixis, Inc. Price, Consensus and EPS Surprise
Exelixis, Inc. price-consensus-eps-surprise-chart | Exelixis, Inc. Quote
The Cabometyx franchise continued to gain momentum in 2026, maintaining its position as the leading prescribed TKI in renal cell carcinoma, the top TKI plus immunotherapy combination in first-line RCC, and the leading oral option in second-line and later neuroendocrine tumors. First-quarter results reflected strong performance, with a record number of new patient starts and the highest-ever first-line RCC market share for Cabometyx plus Opdivo.
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 completed the expansion of its gastrointestinal sales team to support cabozantinib momentum in neuroendocrine tumors and prepare for potential zanzalintinib indications.
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 #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.