-- Cabozantinib franchise achieves approximately $2.123 billion in preliminary U.S. net product revenues for fiscal year 2025 --
-- Fiscal year 2026 net product revenues guidance of $2.325 billion - $2.425 billion --
-- Presentation and webcast at J.P. Morgan 2026 Healthcare Conference tomorrow, Monday, January 12(th) at 5:15 p.m. PT / 8:15 p.m. ET --
ALAMEDA, Calif.--(BUSINESS WIRE)--January 11, 2026--
Exelixis, Inc. (Nasdaq: EXEL) today announced its preliminary unaudited financial results for the fiscal year 2025, provided financial guidance for fiscal year 2026 and delivered an update on its business. Exelixis anticipates 2026 will be a significant year of clinical, regulatory and commercial progress as the company grows its current cabozantinib business, works toward building a potential second commercial franchise with zanzalintinib and moves its earlier stage pipeline forward. As outlined at its December 2025 R&D Day, the company seeks to leverage its diverse pipeline and key clinical collaborations to build next-generation oncology franchises that can improve standards of care for patients with cancer.
Preliminary Fiscal Year 2025 Financial Results & 2026 Financial Guidance
Exelixis is providing the following preliminary unaudited 2025 financial results and financial guidance for 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$(R)$ ).
Fiscal Year 2025 Fiscal Year 2026 Guidance
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$2.525 billion - $2.625
Total revenues $2.320 billion billion
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$2.325 billion - $2.425
Net product revenues $2.123 billion billion(1)
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Cost of goods sold, % of
net product revenues 3.7% 3.5% - 4.5%
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Research and development $875 million - $925
expenses $825 million(2) million(3)
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Selling, general and $575 million - $625
administrative expenses $520 million(4) million(5)
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Effective tax rate n/a(6) 21% - 23%
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Ending cash and marketable $1.65 billion n/p
securities(7)
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(1) Exelixis' 2026 net product revenues guidance range includes the impact
of a U.S. wholesale acquisition cost increase of 3.0% for both
CABOMETYX(R) and COMETRIQ(R) effective on January 1, 2026.
(2) Includes $40.8 million of non-cash stock-based compensation expense.
(3) Includes $50.0 million of non-cash stock-based compensation expense.
(4) Includes $72.2 million of non-cash stock-based compensation expense.
(5) Includes $75.0 million of non-cash stock-based compensation expense.
(6) Preliminary results not yet available.
(7) Cash and marketable securities are composed of cash, cash equivalents
and marketable securities. Fiscal year 2026 guidance not provided
(n/p).
The preliminary 2025 financial information presented in this press release has not been audited and is subject to change. The complete Exelixis Fourth Quarter and Fiscal Year 2025 Financial Results are planned for release after market on Tuesday, February 10, 2026.
"Exelixis enters 2026 with a strong and growing commercial business, the opportunity to bring a potential second oncology franchise to market and an exciting pipeline of novel small molecules and biotherapeutics," said Michael M. Morrissey, Ph.D., President & CEO, Exelixis. "Our momentum accelerated throughout 2025, driven by the continued strong commercial performance of CABOMETYX in renal cell carcinoma and advanced neuroendocrine tumors. We also achieved major milestones with the first positive pivotal data readout and subsequent U.S. regulatory filing for zanzalintinib, our next potential franchise molecule, and drove meaningful pipeline progress."
Dr. Morrissey continued: "To achieve our goal of becoming a top-5 solid tumor oncology company, Exelixis is pursuing a multi-franchise approach that fosters innovation, manages risk and maximizes the value of our portfolio for all our stakeholders. Building on the cabozantinib experience, we aim to establish lasting franchises in renal cell carcinoma, neuroendocrine tumors and colorectal cancer where our products can be successful as monotherapies or in combination, including with other Exelixis pipeline assets. Through careful prioritization and disciplined investments in high-value opportunities, we are confident we can drive sustained near- to mid-term growth while returning capital to shareholders and improving the standards of care for patients with cancer."
Anticipated Cabozantinib Milestones
Growth and Acceleration of Cabozantinib Commercial Franchise. Exelixis expects cabozantinib franchise growth to continue in 2026, building on the product's position as the leading tyrosine kinase inhibitor (TKI) and oral therapy in renal cell carcinoma $(RCC)$ and neuroendocrine tumors $(NET)$. As of the third quarter 2025, in RCC, CABOMETYX(R) (cabozantinib) was the market leader as the number one TKI monotherapy and the most prescribed TKI in combination with immunotherapy (IO). The accelerating uptake in NET builds on the March 2025 U.S. regulatory approval of CABOMETYX for two new NET indications, advanced pancreatic and extra-pancreatic NET (pNET and epNET), based on results from the CABINET study. As of the third quarter 2025, CABOMETYX was the leading oral therapy in the second-or-later line (2L+) NET market, with broad uptake across 2L+ patient types and practice settings. Based on this success and with additional gastrointestinal (GI) cancer opportunities ahead, Exelixis is expediting the full buildout of its GI sales team to accelerate growth in NET and prepare for potential future indications for zanzalintinib in GI cancers.
Anticipated Zanzalintinib Milestones
Ongoing U.S. Regulatory Review in CRC. Exelixis is preparing for the potential first commercial launch of zanzalintinib for the treatment of patients with previously treated CRC, when used in combination with atezolizumab. The regulatory filing was based on positive results from the phase 3 STELLAR-303 pivotal trial, which met one of its dual primary endpoints, with the combination of zanzalintinib and atezolizumab demonstrating a statistically significant reduction in the risk of death versus regorafenib in the intention-to-treat population at the final analysis. An overall survival (OS) benefit with the combination was consistently observed across pre-specified subgroups, including geographic region, RAS status, liver involvement and prior anti-VEGF therapy.
STELLAR-303 CRC Study Final Analysis of Second Dual Primary Endpoint of OS in Patients without Liver Metastases Expected Mid-2026. In 2025, a prespecified interim analysis of STELLAR-303's other dual primary endpoint, OS in patients without liver metastases (non-liver metastases or NLM), showed a trend favoring the combination; however, these data were immature at the data cutoff. The trial is proceeding to the planned final analysis for this endpoint, which is expected in mid-2026, based on current event rates.
Topline Results for STELLAR-304 Anticipated Mid-2026. 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 RCC. The primary endpoints in the trial are progression-free survival $(PFS)$ and objective response rate $(ORR)$. STELLAR-304 completed enrollment in May 2025. Topline results expected in mid-2026, based on current event rates.
Enrollment Progress for STELLAR-311 Trial of Zanzalintinib in Advanced NET. Exelixis is actively enrolling patients in the phase 2/3 STELLAR-311 pivotal trial, which is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced NET, regardless of site of origin, who have received up to one prior line of therapy. Initiated in June 2025, STELLAR-311 is the first study to randomize a small molecule against an active control in this setting, with the potential to broadly redefine oral treatment options for these patients. The primary endpoint of the trial is PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review.
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