On May 5, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the first quarter of 2026, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones.
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"Exelixis made significant progress in the first quarter of 2026 as we remain focused on our goal of building next-generation oncology franchises," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "Our first New Drug Application for zanzalintinib, for its initial potential indication in previously treated metastatic colorectal cancer, was accepted by U.S. regulatory authorities and is under active review, with a target action date of December 3, 2026. We also completed the expansion of our GI Sales team to accelerate cabozantinib’s momentum in neuroendocrine tumors and prepare for potential future indications with zanzalintinib. As the cabozantinib franchise continues to grow and we execute across seven ongoing or soon-to-start pivotal studies for zanzalintinib, we remain committed to strengthening our leadership in GU and GI oncology to improve standards of care for patients and drive long-term value for our shareholders."
Dr. Morrissey continued: "Our R&D organization is on track to deliver multiple milestones this year across our zanzalintinib pivotal development program. We expect key data readouts from STELLAR-303 and STELLAR-304, advancing enrollment in STELLAR-311, and initiation of STELLAR-316. We recently initiated STELLAR-201, a phase 2 study of zanzalintinib in recurrent meningioma, and in April our collaborator Merck initiated LITESPARK-034, the second phase 3 pivotal trial under our clinical collaboration evaluating zanzalintinib in combination with WELIREG in advanced renal cell carcinoma. Today, we also announced two additional zanzalintinib studies: STELLAR-202, a planned phase 2 trial in lung cancer, and a new expansion cohort within the ongoing STELLAR-002 phase 1b/2 study evaluating zanzalintinib in combination with docetaxel in castration-resistant prostate cancer. Finally, we expect to complete our current $750 million stock repurchase program this month and initiate an additional $750 million program authorized by our Board in May 2026."
First Quarter 2026 Financial Results
Total revenues for the quarter ended March 31, 2026 were $610.8 million, as compared to $555.4 million for the comparable period in 2025.
Total revenues for the quarter ended March 31, 2026 included net product revenues of $555.0 million, as compared to $513.3 million for the comparable period in 2025. The increase in net product revenues was primarily due to an increase in sales volume.
Collaboration revenues, composed of license revenues and collaboration services revenues, were $55.8 million for the quarter ended March 31, 2026, as compared to $42.2 million for the comparable period in 2025. The increase in collaboration revenues was primarily related to higher royalty revenues for the sales of cabozantinib outside the U.S. generated by Exelixis’ collaboration partner Ipsen Pharma SAS (Ipsen) and higher milestone-related revenues recognized in the quarter, partially offset by lower development cost reimbursements earned.
Research and development expenses for the quarter ended March 31, 2026 were $199.9 million, as compared to $212.2 million for the comparable period in 2025. The decrease in research and development expenses was primarily related to decreases in clinical trial costs and manufacturing costs to support our development candidates, partially offset by an increase in license and other collaboration costs.
Selling, general and administrative expenses for the quarter ended March 31, 2026 were $139.6 million, as compared to $137.2 million for the comparable period in 2025. The increase in selling, general and administrative expenses was primarily related to increases in marketing activities, legal and advisory fees, and personnel expenses, partially offset by a decrease in corporate giving.
Provision for income taxes for the quarter ended March 31, 2026 was $57.2 million, as compared to $46.1 million for the comparable period in 2025.
GAAP net income for the quarter ended March 31, 2026 was $210.5 million, or $0.81 per share, basic and $0.79 per share, diluted, as compared to GAAP net income of $159.6 million, or $0.57 per share, basic and $0.55 per share, diluted, for the comparable period in 2025. GAAP net income per share for the quarter ended March 31, 2026 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended March 31, 2026, as compared to the comparable period in 2025, as a result of the stock repurchase programs.
Non-GAAP net income for the quarter ended March 31, 2026 was $232.8 million, or $0.90 per share, basic and $0.87 per share, diluted, as compared to non-GAAP net income of $179.6 million, or $0.64 per share, basic and $0.62 per share, diluted, for the comparable period in 2025.
Non-GAAP Financial Measures
To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented.
Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.
2026 Financial Guidance
Exelixis is maintaining the previously provided financial guidance for fiscal year 2026. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential U.S. regulatory approval and commercial launch of zanzalintinib for the treatment of patients with previously treated metastatic colorectal cancer (CRC). The U.S. Food and Drug Administration (FDA) is currently reviewing Exelixis’ New Drug Application (NDA) for this proposed indication, when used in combination with atezolizumab (Tecentriq).
Total revenues
$2.525 billion – $2.625 billion
Net product revenues
$2.325 billion – $2.425 billion(1)
Cost of goods sold, % of net product revenues 3.5% – 4.5%
Research and development expenses
$875 million – $925 million(2)
Selling, general and administrative expenses
$575 million – $625 million(3)
Effective tax rate 21% – 23%
Cabozantinib Highlights
Net product revenues generated by the cabozantinib franchise in the U.S. were $555.0 million during the first quarter of 2026, with net product revenues of $552.8 million from CABOMETYX (cabozantinib) and $2.2 million from COMETRIQ (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners, Ipsen and Takeda Pharmaceutical Company Limited, during the quarter ended March 31, 2026, Exelixis earned $45.9 million in royalty revenues.
Zanzalintinib Highlights
FDA Acceptance of NDA for Zanzalintinib in Combination with Atezolizumab for Previously Treated Metastatic CRC, Based on Positive Results of STELLAR-303 Phase 3 Pivotal Trial. In February 2026, Exelixis announced that the U.S. FDA accepted its NDA for zanzalintinib as a treatment for patients with metastatic CRC, when used in combination with atezolizumab. The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026. The NDA was based on positive results from the STELLAR-303 phase 3 pivotal trial, in which zanzalintinib in combination with atezolizumab demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intention-to-treat (ITT) population. An OS benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy.
The trial is proceeding to the planned final analysis of the other dual primary endpoint, OS in patients without liver metastases (NLM), which is expected in mid-2026, depending on event rates.
Topline Results for STELLAR-304 Phase 3 Pivotal Trial Expected in Second Half of 2026. Today, Exelixis announced that the company expects topline results from the STELLAR-304 trial in the second half of 2026, depending on event rates. STELLAR-304 is a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell renal cell carcinoma (RCC). The primary endpoints of the trial are progression-free survival (PFS) as assessed by blinded independent radiology committee and objective response rate (ORR) per RECIST 1.1, with OS as the secondary endpoint.
Enrollment Progress for STELLAR-311 Phase 2/3 Pivotal Trial. Exelixis is continuing to actively enroll patients in the STELLAR-311 phase 2/3 pivotal trial. STELLAR-311 is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced neuroendocrine tumors, regardless of site of origin, who have received up to one prior line of therapy. The primary endpoint of the trial is PFS per RECIST 1.1 as assessed by blinded independent central review.
Collaboration Agreement with Natera for STELLAR-316 Phase 3 Pivotal Trial. In January 2026, Exelixis announced a collaboration with Natera, a global leader in cell-free DNA and precision medicine, for STELLAR-316, the planned, Exelixis-sponsored phase 3 pivotal trial. STELLAR-316 will evaluate zanzalintinib, with and without an immune checkpoint inhibitor, in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease. The primary endpoint of STELLAR-316 will be disease-free survival, with secondary endpoints including circulating tumor DNA clearance. Natera will provide its Signatera assay to identify MRD+ patients for trial enrollment. Exelixis expects to initiate STELLAR-316 in mid-2026.
Initiation of LITESPARK-034 Phase 3 Pivotal Trial as Part of Clinical Development Collaboration with Merck. In April 2026, Exelixis’ collaborator Merck, known as MSD outside of the United States and Canada, initiated LITESPARK-034, a global phase 3 pivotal trial evaluating zanzalintinib in combination with WELIREG (belzutifan) versus WELIREG and placebo in second-line or later advanced RCC patients who have progressed on or after both programmed death-ligand 1 (PD-1/L1) and vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapies in sequence or in combination. LITESPARK-034 is the second of two Merck-sponsored phase 3 pivotal trials of zanzalintinib and WELIREG in RCC under the companies’ clinical development collaboration. Merck initiated the first trial, LITESPARK-033, in December 2025. LITESPARK-033 is evaluating the combination of zanzalintinib and WELIREG versus cabozantinib in first-line advanced RCC following an immunotherapy administered in the adjuvant setting.
Initiation of STELLAR-201 Phase 2 Trial in Recurrent Meningioma. Today, Exelixis announced it has initiated STELLAR-201, a phase 2 trial evaluating zanzalintinib in patients with recurrent Grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies. The primary endpoint of the trial is ORR, with secondary endpoints including PFS, duration of response (DOR) and OS. Pending favorable results, the trial represents an opportunity for zanzalintinib to become the first and only systemic therapy for this form of cancer where patients have few effective treatment options.
Expansion of Zanzalintinib Clinical Development Program. Today, Exelixis announced two additional studies for zanzalintinib, including STELLAR-202, a planned phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous non-small cell lung cancer, and an additional expansion cohort in the ongoing phase 1b/2 STELLAR-002 study evaluating zanzalintinib in combination with docetaxel in metastatic castration-resistant prostate cancer patients with measurable disease. Exelixis expects to initiate STELLAR-202 and open the expansion cohort of STELLAR-002 in the second half of 2026.
Corporate Highlights
Zanzalintinib and Cabozantinib Data Presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2026). Zanzalintinib and cabozantinib will be the subject of numerous presentations at ASCO (Free ASCO Whitepaper) 2026, which is being held from May 29 through June 2 in Chicago. Notable presentations will include an analysis of the contribution of atezolizumab to the efficacy of the combination of zanzalintinib plus atezolizumab in patients with previously treated metastatic CRC in the phase 3 STELLAR-303 trial, as well as a subgroup analysis from the phase 3 CABINET pivotal trial regarding hormone functional status.
October 2025 Stock Repurchase Program (SRP) Update and Announcement of New $750 million SRP Authorized in May 2026. As of the end of the first quarter of 2026, Exelixis repurchased $590.6 million of the company’s stock, at an average price of $43.14 per share under the current SRP authorized in October 2025 (October 2025 SRP). Exelixis expects to complete the remainder of the October 2025 SRP in May 2026, fulfilling its commitment to purchase a total of $750 million of the company’s stock under the October 2025 SRP before December 31, 2026. Since Exelixis’ Board of Directors authorized the first SRP in March 2023, Exelixis has repurchased a total of $2.59 billion of the company’s common stock, retiring 86.8 million shares, at an average price of $29.86 per share, as of the end of the first quarter of 2026.
In May 2026, Exelixis’ Board of Directors authorized the repurchase of up to an additional $750 million of the company’s common stock by December 31, 2027 (May 2026 SRP). The newly authorized May 2026 SRP is the sixth such program undertaken by Exelixis since March 2023. Stock repurchases under these programs may be made from time to time through a variety of methods, which may include open market purchases, in block trades, Rule 10b5-1 trading plans, accelerated share repurchase transactions, exchange transactions or any combination of such methods. The timing and amount of any stock repurchases under the programs will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. The programs do not obligate Exelixis to acquire any amount of its common stock, and may be modified, suspended or discontinued at any time without prior notice.
Basis of Presentation
Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended April 3, 2026 and April 4, 2025, are indicated as being as of and for the periods ended March 31, 2026 and March 31, 2025, respectively.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the first quarter of 2026 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, May 5, 2026.
To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on www.exelixis.com for one year.
(Press release, Exelixis, MAY 5, 2026, View Source [SID1234665116])