Exelixis Announces First Quarter 2026 Financial Results and Provides Corporate Update
Key Terms
new drug application regulatory
pdufa regulatory
overall survival medical
intention-to-treat medical
progression-free survival medical
objective response rate medical
recist 1.1 medical
molecular residual disease medical
- Total Revenues of
- GAAP Diluted EPS of
- Announced Additional Stock Repurchase Program for up to
- Conference Call and Webcast Today at 5:00 PM ET -
“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
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
First Quarter 2026 Financial Results
Total revenues for the quarter ended March 31, 2026 were
Total revenues for the quarter ended March 31, 2026 included net product revenues of
Collaboration revenues, composed of license revenues and collaboration services revenues, were
Research and development expenses for the quarter ended March 31, 2026 were
Selling, general and administrative expenses for the quarter ended March 31, 2026 were
Provision for income taxes for the quarter ended March 31, 2026 was
GAAP net income for the quarter ended March 31, 2026 was
Non-GAAP net income for the quarter ended March 31, 2026 was
Non-GAAP Financial Measures
To supplement Exelixis’ financial results presented in accordance with
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
Total revenues |
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Net product revenues |
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Research and development expenses |
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Selling, general and administrative expenses |
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Effective tax rate |
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Exelixis’ 2026 net product revenues guidance range includes the impact of a |
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Cabozantinib Highlights
Net product revenues generated by the cabozantinib franchise in the
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
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
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 Annual Meeting (ASCO 2026). Zanzalintinib and cabozantinib will be the subject of numerous presentations at ASCO 2026, which is being held from May 29 through June 2 in
October 2025 Stock Repurchase Program (SRP) Update and Announcement of New
In May 2026, Exelixis’ Board of Directors authorized the repurchase of up to an additional
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.
About Exelixis
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our pipeline of franchise molecules, including our novel oral kinase inhibitor zanzalintinib, and to extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ goal of building next-generation oncology franchises; Exelixis’ goal to accelerate cabozantinib’s momentum in NET and prepare for potential future indications for zanzalintinib, supported by the completed expansion of its Gastrointestinal (GI) Sales team; Exelixis’ commitment to strengthening its leadership in genitourinary (GU) and GI oncology to improve standards of care for patients and drive long‑term value for shareholders through continued growth of the cabozantinib franchise and its execution across seven ongoing or soon-to-start pivotal studies for zanzalintinib; Exelixis’ clinical development plans for, and beliefs regarding the therapeutic potential of, zanzalintinib; Exelixis’ plans to deliver multiple milestones in 2026 across the zanzalintinib pivotal development program, including the anticipated timing for pivotal data milestones for the STELLAR-303 and STELLAR-304 trials, plans to advance enrollment in STELLAR-311 and initiate additional zanzalintinib trials in 2026, including STELLAR-316, STELLAR-202, and an expansion cohort in the ongoing STELLAR-002 phase 1b/2 study; complexities and the unpredictability of the regulatory review and approval process with respect to Exelixis’ NDA for zanzalintinib for the treatment of patients with previously treated metastatic CRC, when used in combination with atezolizumab, including the risk that the FDA may not approve zanzalintinib as a treatment for metastatic CRC in a timely fashion, if at all; Exelixis’ expectations with respect to its clinical development collaboration with Merck, including the LITESPARK-033 and LITESPARK-034 pivotal trials; Exelixis’ expectations with respect to the STELLAR-201 trial, and its belief that pending favorable results, the trial represents an opportunity for zanzalintinib to become the first and only systemic therapy for recurrent Grade I/II/III meningioma where patients have few effective treatment options; Exelixis’ plans to present cabozantinib and zanzalintinib data, including data from the STELLAR-303 and CABINET trials, at ASCO 2026; Exelixis’ fiscal year 2026 financial guidance; the timing, amount, and completion of any stock repurchase programs; Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future; and other statements that are not historical facts. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the degree of market acceptance of CABOMETYX and other Exelixis products in the indications for which they are approved and in the territories where they are approved, and Exelixis’ and its partners’ ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX and other Exelixis products in comparison to competing products; complexities and the unpredictability of the regulatory review and approval processes in the
Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered
TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
WELIREG® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
EXELIXIS, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (in thousands, except per share amounts) (unaudited) |
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Three Months Ended March 31, |
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|
|
2026 |
|
|
2025 |
|
Revenues: |
|
|
|
|||
Net product revenues |
$ |
554,977 |
|
$ |
513,283 |
|
Collaboration revenues |
|
55,835 |
|
|
42,164 |
|
Total revenues |
|
610,812 |
|
|
555,447 |
|
Operating expenses: |
|
|
|
|||
Cost of goods sold |
|
19,953 |
|
|
19,172 |
|
Research and development |
|
199,916 |
|
|
212,233 |
|
Selling, general and administrative |
|
139,602 |
|
|
137,183 |
|
Total operating expenses |
|
359,471 |
|
|
368,588 |
|
Income from operations |
|
251,341 |
|
|
186,859 |
|
Interest income |
|
16,127 |
|
|
19,076 |
|
Other income (expenses), net |
|
219 |
|
|
(245 |
) |
Income before income taxes |
|
267,687 |
|
|
205,690 |
|
Provision for income taxes |
|
57,220 |
|
|
46,074 |
|
Net income |
$ |
210,467 |
|
$ |
159,616 |
|
Net income per share: |
|
|
|
|||
Basic |
$ |
0.81 |
|
$ |
0.57 |
|
Diluted |
$ |
0.79 |
|
$ |
0.55 |
|
Weighted-average common shares outstanding: |
|
|
|
|||
Basic |
|
258,329 |
|
|
278,804 |
|
Diluted |
|
267,322 |
|
|
288,177 |
|
EXELIXIS, INC. RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (in thousands, except per share amounts) (unaudited) |
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|
Three Months Ended March 31, |
||||||
|
|
2026 |
|
|
|
2025 |
|
GAAP net income |
$ |
210,467 |
|
|
$ |
159,616 |
|
Adjustments: |
|
|
|
||||
Stock-based compensation - research and development(1) |
|
12,318 |
|
|
|
9,522 |
|
Stock-based compensation - selling, general and administrative(1) |
|
16,732 |
|
|
|
16,408 |
|
Income tax effect of the above adjustments |
|
(6,757 |
) |
|
|
(5,993 |
) |
Non-GAAP net income |
$ |
232,760 |
|
|
$ |
179,553 |
|
GAAP net income per share: |
|
|
|
||||
Basic |
$ |
0.81 |
|
|
$ |
0.57 |
|
Diluted |
$ |
0.79 |
|
|
$ |
0.55 |
|
Non-GAAP net income per share: |
|
|
|
||||
Basic |
$ |
0.90 |
|
|
$ |
0.64 |
|
Diluted |
$ |
0.87 |
|
|
$ |
0.62 |
|
Weighted-average common shares outstanding: |
|
|
|
||||
Basic |
|
258,329 |
|
|
|
278,804 |
|
Diluted |
|
267,322 |
|
|
|
288,177 |
|
____________________ |
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(1) |
Non-cash stock-based compensation used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20260505082022/en/
Contacts:
Chris Senner
Chief Financial Officer
Exelixis, Inc.
650-837-7240
csenner@exelixis.com
Andrew Peters
SVP, Strategy & Investor Relations
Exelixis, Inc.
650-837-7248
apeters@exelixis.com
Source: Exelixis, Inc.