Exelixis Announces Third Quarter 2026 Financial Results and Provides Corporate Update
Higher product sales lifted quarterly earnings, while the FDA review timeline for zanzalintinib moved out by three months.
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– Total Revenues of
– GAAP Diluted EPS of
– Conference Call and Webcast Today at 5:00 PM ET –
“Exelixis continued to execute across all of our key priorities in the third quarter, driving the cabozantinib franchise forward while preparing for zanzalintinib as our next potential franchise opportunity,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “The zanzalintinib development program gained further momentum as the organization focused on trial initiations, enrollment progress for ongoing studies and in-depth planning for the next wave of new pivotal trials. The enthusiasm around the zanzalintinib franchise continues, and we look forward to sharing more progress when appropriate. As we execute on our priorities, we remain disciplined in our deployment of capital as we invest in our R&D portfolio, return value to shareholders through our stock repurchase program and actively evaluate external innovation opportunities that can strengthen our pipeline and create long-term value for patients and all of our stakeholders.”
Third Quarter 2026 Financial Results
Total revenues for the quarter ended September 30, 2026 were
Total revenues for the quarter ended September 30, 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 September 30, 2026 were
Selling, general and administrative expenses for the quarter ended September 30, 2026 were
Provision for income taxes for the quarter ended September 30, 2026 was
GAAP net income for the quarter ended September 30, 2026 was
Non-GAAP net income for the quarter ended September 30, 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 providing the following updated financial guidance for fiscal year 2026. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential
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Current Guidance (provided on October 29, 2026) |
Previous Guidance (provided on August 5, 2026) |
Total revenues |
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Net product revenues |
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Cost of goods sold, % of 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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(1) |
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Exelixis’ 2026 net product revenues guidance range includes the impact of a |
(2) |
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Includes |
(3) |
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Includes |
Cabozantinib Franchise Highlights
Net product revenues generated by the cabozantinib franchise in the
Zanzalintinib GI Highlights
Ongoing Regulatory Review of Zanzalintinib in Combination with Atezolizumab (Tecentriq®) for Previously Treated Metastatic CRC with Prescription Drug User Fee Act (PDUFA) Target Action Date of March 3, 2027. The
Initiation of Phase 3 STELLAR-316 Pivotal Trial in Collaboration with Merck and Natera. In August 2026, Exelixis initiated the phase 3 STELLAR-316 pivotal trial evaluating zanzalintinib, with and without KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), 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 is disease-free survival, with key secondary endpoints including circulating tumor DNA clearance. Exelixis is sponsoring the study; Merck, known as MSD outside of
Enrollment Progressing Rapidly for Phase 2/3 STELLAR-311 Pivotal Trial. Exelixis is continuing to actively enroll patients in the phase 2/3 STELLAR-311 pivotal trial. STELLAR-311 is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced neuroendocrine tumors (NET), regardless of site of origin, who have received up to one prior line of therapy. The primary endpoint of the trial is progression-free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review.
Zanzalintinib GU Highlights
Topline Results for Phase 3 STELLAR-304 Pivotal Trial Expected in First Quarter of 2027. Today, Exelixis announced it expects topline results from the phase 3 STELLAR-304 pivotal trial in the first quarter of 2027. STELLAR-304 is evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell renal cell carcinoma (nccRCC). The primary endpoints of the trial are PFS as assessed by blinded independent radiology committee and objective response rate (ORR) per RECIST 1.1, with OS as the secondary endpoint.
Phase 3 LITESPARK-033 and LITESPARK-034 Pivotal Trials as Part of Clinical Development Collaboration with Merck. The Merck-sponsored global phase 3 pivotal trials, LITESPARK-033 and LITESPARK-034, are active and enrolling patients as part of Exelixis’ clinical development collaboration with Merck evaluating zanzalintinib in combination with WELIREG® (belzutifan) in advanced renal cell carcinoma (RCC). LITESPARK-033, initiated by Merck in December 2025, is evaluating the combination of zanzalintinib and WELIREG versus cabozantinib in first-line advanced RCC following an immunotherapy administered in the adjuvant setting. LITESPARK-034, initiated by Merck in April 2026, is evaluating zanzalintinib in combination with WELIREG versus WELIREG and placebo in second-line or later advanced RCC patients who have progressed on or after both programmed death-1/ligand 1 (PD-1/L1) and vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapies in sequence or in combination.
Enrollment Ongoing in Metastatic Bladder Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohorts of Phase 1b/2 STELLAR-002 Study. In August 2026, Exelixis announced the initiation of metastatic bladder cancer and mCRPC expansion cohorts as part of the ongoing phase 1b/2 STELLAR-002 study. The STELLAR-002 expansion cohorts are evaluating zanzalintinib monotherapy in patients with metastatic bladder cancer who have progressed following treatment with enfortumab vedotin and pembrolizumab, as well as zanzalintinib in combination with docetaxel in mCRPC patients with measurable disease.
Zanzalintinib Development Program Highlights
Initiation of Phase 2 STELLAR-202 Trial in Squamous Non-small Cell Lung Cancer (NSCLC). In October 2026, Exelixis initiated STELLAR-202, a phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous NSCLC. The primary endpoint of the trial is six-month PFS (PFS-6), with secondary endpoints including safety, PFS, OS, ORR and duration of response (DOR). The study is currently enrolling.
Enrollment Ongoing in Phase 2 STELLAR-201 Trial in Recurrent Meningioma. Enrollment is ongoing for the phase 2 STELLAR-201 trial. Initiated in April 2026, STELLAR-201 is 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, 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 meningioma, the most common primary intracranial neoplasm for which there are currently no approved systemic therapies.
Corporate Highlights
Stock Repurchase Program (SRP) Update. In May 2026, Exelixis’ Board of Directors authorized the repurchase of up to
Stock repurchases under the May 2026 SRP 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 program 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 program does not obligate us to acquire any amount of our common stock, and may be modified, suspended or discontinued at any time without prior notice.
Announcement of Settlement with Azurity Pharmaceuticals, Inc. (Azurity). On October 28, 2026, we entered into a settlement and license agreement with Azurity (the Azurity Settlement Agreement) to resolve the Azurity litigation. Pursuant to the terms of the Azurity Settlement Agreement, we will grant Azurity a license to market its proposed 505(b)(2) NDA product in the
Announcement on Patent Litigation Trial Appeal with MSN Laboratories. In August 2026, the
Basis of Presentation
Exelixis uses 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 October 2, 2026 and October 3, 2025, are indicated as being as of and for the periods ended September 30, 2026 and September 30, 2025, respectively.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the third 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, Thursday, October 29, 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’ belief in zanzalintinib as its next potential franchise opportunity; Exelixis’ focus on disciplined capital deployment, including investing in its R&D portfolio, returning value to shareholders through its stock repurchase programs, and evaluating external innovation opportunities that may strengthen its pipeline and create long-term value; Exelixis’ clinical development plans for zanzalintinib, including progress on additional pivotal trials and plans to share progress when appropriate; Exelixis’ plans to present detailed findings from the NLM subpopulation for STELLAR-303 at a future medical conference; the anticipated timing of topline results from STELLAR-304; Exelixis’ belief that, pending favorable results, STELLAR-201 represents an opportunity for zanzalintinib to become the first and only systemic therapy for recurrent Grade I/II/III meningioma; Exelixis’ expectations regarding the timing and outcome of FDA review of its NDA for zanzalintinib in combination with atezolizumab for previously treated metastatic CRC; Exelixis’ expectations regarding the implications of the appellate ruling in its patent litigation with MSN for the timing of any final FDA approval and
Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
WELIREG® and KEYTRUDA QLEX™ are registered trademarks 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 September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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|
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2026 |
|
|
|
2025 |
|
Revenues: |
|
|
|
|
|
|
|
||||||||
Net product revenues |
$ |
604,924 |
|
$ |
542,930 |
|
$ |
1,732,926 |
|
$ |
1,576,227 |
||||
Collaboration revenues |
|
53,772 |
|
|
|
54,825 |
|
|
|
165,272 |
|
|
|
145,236 |
|
Total revenues |
|
658,696 |
|
|
|
597,755 |
|
|
|
1,898,198 |
|
|
|
1,721,463 |
|
Operating expenses: |
|
|
|
|
|
|
|
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Cost of goods sold |
|
26,233 |
|
|
|
18,574 |
|
|
|
66,843 |
|
|
|
57,216 |
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Research and development |
|
209,481 |
|
|
|
199,164 |
|
|
|
621,384 |
|
|
|
611,753 |
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Selling, general and administrative |
|
154,559 |
|
|
|
123,661 |
|
|
|
441,793 |
|
|
|
395,703 |
|
Restructuring |
|
— |
|
|
|
19,816 |
|
|
|
— |
|
|
|
19,816 |
|
Total operating expenses |
|
390,273 |
|
|
|
361,215 |
|
|
|
1,130,020 |
|
|
|
1,084,488 |
|
Income from operations |
|
268,423 |
|
|
|
236,540 |
|
|
|
768,178 |
|
|
|
636,975 |
|
Interest income |
|
14,315 |
|
|
|
15,922 |
|
|
|
44,652 |
|
|
|
51,787 |
|
Other income (expenses), net |
|
47 |
|
|
|
(49 |
) |
|
|
320 |
|
|
|
(244 |
) |
Income before income taxes |
|
282,785 |
|
|
|
252,413 |
|
|
|
813,150 |
|
|
|
688,518 |
|
Provision for income taxes |
|
64,690 |
|
|
|
58,835 |
|
|
|
172,538 |
|
|
|
150,476 |
|
Net income |
$ |
218,095 |
|
|
$ |
193,578 |
|
|
$ |
640,612 |
|
|
$ |
538,042 |
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Net income per share: |
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|
|
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|
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Basic |
$ |
0.88 |
|
|
$ |
0.72 |
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|
$ |
2.54 |
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|
$ |
1.97 |
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Diluted |
$ |
0.85 |
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|
$ |
0.69 |
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|
$ |
2.46 |
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|
$ |
1.90 |
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Weighted-average common shares outstanding: |
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|
|
|
|
|
|
||||||||
Basic |
|
246,756 |
|
|
|
268,421 |
|
|
|
251,964 |
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|
|
273,269 |
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Diluted |
|
255,754 |
|
|
|
278,535 |
|
|
|
260,917 |
|
|
|
283,701 |
|
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 September 30, |
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Nine Months Ended September 30, |
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|
2026 |
|
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2025 |
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|
|
2026 |
|
|
|
2025 |
|
GAAP net income |
$ |
218,095 |
|
|
$ |
193,578 |
|
|
$ |
640,612 |
|
|
$ |
538,042 |
|
Adjustments: |
|
|
|
|
|
|
|
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Stock-based compensation - research and development(1) |
|
11,069 |
|
|
|
10,353 |
|
|
|
35,731 |
|
|
|
34,018 |
|
Stock-based compensation - selling, general and administrative(1) |
|
17,649 |
|
|
|
20,532 |
|
|
|
54,600 |
|
|
|
58,868 |
|
Income tax effect of the above adjustments |
|
(6,588 |
) |
|
|
(6,569 |
) |
|
|
(20,857 |
) |
|
|
(20,917 |
) |
Non-GAAP net income |
$ |
240,225 |
|
|
$ |
217,894 |
|
|
$ |
710,086 |
|
|
$ |
610,011 |
|
GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.88 |
|
|
$ |
0.72 |
|
|
$ |
2.54 |
|
|
$ |
1.97 |
|
Diluted |
$ |
0.85 |
|
|
$ |
0.69 |
|
|
$ |
2.46 |
|
|
$ |
1.90 |
|
Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.97 |
|
|
$ |
0.81 |
|
|
$ |
2.82 |
|
|
$ |
2.23 |
|
Diluted |
$ |
0.94 |
|
|
$ |
0.78 |
|
|
$ |
2.72 |
|
|
$ |
2.15 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
246,756 |
|
|
|
268,421 |
|
|
|
251,964 |
|
|
|
273,269 |
|
Diluted |
|
255,754 |
|
|
|
278,535 |
|
|
|
260,917 |
|
|
|
283,701 |
|
(1) |
|
Non-cash stock-based compensation used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20261029052392/en/
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.