EXEL

EXELIXIS, INC.

NASDAQ · HEALTH CARE · BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)

64.58

+0.19 +0.30%

USD · close Oct 21

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MKT CAP $16BP/E 20.3DIV YIELD —FCF YIELD 7.33%REV TTM $2.4B +9.2%NET INCOME $860.6M +42.9%NET CASH $281.4M52W 36.08 – 64.58SEC XBRL · TTM TO Invalid Date

How EXEL rewrote its risk factors

10-K ITEM 1A · FY2025 → FY2026

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Risk Factors” below. • Our ability to grow our company is dependent upon the commercial success of CABOMETYX in its approved indications and, to a lesser degree, the continued clinical development, regulatory approval, clinical acceptance and commercial success of the cabozantinib franchise. • If we are unable to obtain or maintain coverage and reimbursement for our products from government and other third-party payers, our business will suffer. • Current healthcare laws, policies, and regulations in the U.S. and future legislative or regulatory reforms to the U.S. healthcare system, including those related to drug pricing, may affect our ability to commercialize our marketed products profitably.
Initiatives arising from this scrutiny may result in changes that have the effect of reducing our revenue, or harming our business or reputation. • The timing of the entrance of generic competitors to CABOMETYX and legislative and regulatory action designed to reduce barriers to the development, approval and adoption of generic drugs in the U.S. could limit the revenue we derive from our products, most notably CABOMETYX, which could have a material adverse impact on our business, financial condition and results of operations. • We may be unable to expand our discovery and development pipeline, which could limit our growth and revenue potential. • Clinical testing of our product candidates is a lengthy, costly, complex and uncertain process that may ultimately fail to demonstrate sufficiently differentiated safety and efficacy data for those products to compete in our highly competitive market environment. • The regulatory approval processes of the U.S.
For example, we rely on Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda) for the commercial success of CABOMETYX in its approved indications outside of the U.S., and we are unable to control the amount or timing of resources expended by these collaboration partners in the commercialization of CABOMETYX in its approved indications outside of the U.S.
Fiscal year 2025, which was a 52-week fiscal year, ended on January 2, 2026; fiscal year 2024, which was a 53-week fiscal year, ended on January 3, 2025; and fiscal year 2023, which was a 52-week fiscal year, ended on December 29, 2023.
For convenience, references in this report as of and for the fiscal years ended January 2, 2026, January 3, 2025 and December 29, 2023, are indicated as being as of and for the years ended December 31, 2025, 2024 and 2023, respectively.
In fiscal year 2026, the annual period will end on January 1, 2027 and will be a 52-week fiscal year.
(Exelixis, we, our or us) is an oncology company innovating next-generation medicines and regimens at the forefront of cancer care.
We have produced four marketed pharmaceutical products, two of which are formulations of our flagship molecule, cabozantinib, and we are steadily advancing and evolving our product pipeline portfolio, including our lead clinical asset, zanzalintinib, currently under review by the U.S.
Food and Drug Administration (FDA) for the treatment of certain forms of colorectal cancer (CRC), as well as the focus of an extensive late-stage clinical development program in other indications.
With a rational and disciplined approach to investment, we are leveraging our internal experience and expertise and the strength of strategic partnerships, to identify and pursue opportunities across the landscape of scientific modalities, including small molecules and biotherapeutics, such as antibody-drug conjugates (ADCs).
Cabozantinib is an inhibitor of multiple tyrosine kinases, including MET, AXL, VEGF receptors and RET and has been approved by the FDA, and in 68 other countries for all or a combination of, the following: as CABOMETYX® (cabozantinib) tablets for advanced renal cell carcinoma (RCC) (both alone and in combination with Bristol-Myers Squibb Company’s (BMS) nivolumab (OPDIVO®)), previously treated hepatocellular carcinoma (HCC), previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC) and previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and extra-pancreatic neuroendocrine tumors (epNET); and as COMETRIQ® (cabozantinib) capsules for progressive, metastatic medullary thyroid cancer (MTC).
(a member of the Roche Group) (Genentech); and MINNEBRO® (esaxerenone), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor, approved for the treatment of hypertension in Japan and licensed to Daiichi Sankyo Company, Limited (Daiichi Sankyo).
See “—Collaborations and Business Development Activities—Other Collaborations.” 2025 was our ninth consecutive year of annual profitability; it featured growth in net product revenues of approximately 17% year-over-year as a result of increased sales of our cabozantinib products in the U.S., supplemented by an approximately 7% year-over-year increase in royalties earned pursuant to collaboration agreements with our ex-U.S. partners.
We plan to continue leveraging our operating cash flows to advance a broad array of diverse biotherapeutics and small molecule programs for the treatment of cancer, as well as to support company-sponsored and externally sponsored clinical trials evaluating cabozantinib and zanzalintinib.
Zanzalintinib is a novel oral inhibitor of kinases including the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors.
Our zanzalintinib development program includes a series of ongoing and planned pivotal trials to explore its therapeutic potential in CRC, clear cell (cc) and non-clear cell (ncc) RCC, neuroendocrine tumors (NET) and meningioma, as well as earlier-stage trials.
Our pipeline programs in phase 1 development each have best-in-class potential and include: XL309, a small molecule inhibitor of USP1, which has emerged as a synthetic lethal target in the context of BRCA-mutated tumors; XB010, an ADC consisting of a monomethyl auristatin E (MMAE) payload conjugated to a monoclonal antibody (mAb) targeting the tumor antigen 5T4; XB628, a first-in-class bispecific antibody that simultaneously targets programmed cell death ligand 1 (PD-L1) and natural killer cell receptor group 2A (NKG2A), identified as key regulators of adaptive and innate immune cell activity; and XB371, a next-generation tissue factor (TF)-targeting ADC with a topoisomerase inhibitor payload.
We complement our internal drug discovery and development efforts by in-licensing or acquiring, or obtaining options to in-license or acquire, investigational oncology assets from third parties if those oncology assets demonstrate evidence of, or potential for, clinical success.
Exelixis Marketed Products: CABOMETYX and COMETRIQ As detailed below, CABOMETYX and COMETRIQ have been approved to treat patients with various forms of cancer by the FDA for the U.S. market, the European Commission (EC), following European Medicines Agency (EMA) review for the European Economic Area (EEA), which covers all 27 member states of the European Union and Norway, Lichtenstein and Iceland (Member States of the EEA), the Medicines and Healthcare products Regulatory Agency for the United Kingdom (U.K.) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the Japanese market, as well as by comparable regulatory authorities across other markets worldwide.
Product Indication Approval Date Regimen Major Markets CABOMETYX® (cabozantinib) Renal Cell Carcinoma (RCC) Patients with advanced RCC who have received prior anti-angiogenic therapy April 25, 2016 Monotherapy U.S.
Advanced RCC in adults following prior VEGF-targeted therapy September 9, 2016 Monotherapy EEA/U.K.
Patients with advanced RCC December 19, 2017 Monotherapy U.S.
First-line treatment of adults with intermediate- or poor-risk advanced RCC May 17, 2018 Monotherapy EEA/U.K.
Patients with curatively unresectable or metastatic RCC March 25, 2020 Monotherapy Japan First-line treatment of patients with advanced RCC January 22, 2021 Combination with nivolumab U.S.
First-line treatment for patients with advanced RCC March 31, 2021/May 13, 2021 Combination with nivolumab EEA/U.K.
Patients with unresectable or metastatic RCC August 25, 2021 Combination with nivolumab Japan Hepatocellular Carcinoma (HCC) HCC in adults who have previously been treated with sorafenib November 15, 2018 Monotherapy EEA/U.K.
Patients with HCC who have been previously treated with sorafenib January 14, 2019 Monotherapy U.S.
Adult patients with locally advanced or metastatic DTC, refractory pr not eligible to RAI who have progressed during or after prior systemic therapy May 3, 2022/May 10, 2022 Monotherapy EEA/U.K.
Pancreatic Neuroendocrine Tumors (pNET) and Extra-Pancreatic Neuroendocrine Tumors (epNET) Adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pNET and epNET March 26, 2025 Monotherapy U.S.
Adult patients with unresectable or metastatic, well differentiated epNET and pNET neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues July 23, 2025/September 18, 2025 Monotherapy EEA/U.K.
COMETRIQ® (cabozantinib) Medullary Thyroid Cancer (MTC) Patients with progressive, metastatic MTC November 29, 2012 Monotherapy U.S.
Adult patients with progressive, unresectable locally advanced or metastatic MTC March 25, 2014 Monotherapy EEA/U.K.
In 2025, 2024 and 2023, we generated $2,122.8 million, $1,809.4 million and $1,628.9 million, respectively, in net product revenues from sales of CABOMETYX and COMETRIQ.
In 2025, 2024 and 2023, we earned $179.2 million, $166.9 million and $148.5 million, respectively, of royalties on net sales of cabozantinib products outside of the U.S.
For additional information on the terms of our collaboration agreements with Ipsen and Takeda, see “—Collaborations and Business Development Activities—Cabozantinib Commercial Collaborations . ” Renal Cell Carcinoma - CABOMETYX is a Leading Tyrosine Kinase Inhibitor (TKI) Treatment Option for Patients with Advanced RCC Over time, CABOMETYX has been increasingly adopted in the treatment of patients with RCC, reflecting its establishment as a standard of care in clinical practice.
In 2026, approximately 34,000 patients with advanced kidney cancer will require systemic therapy in the U.S., with approximately 22,000 patients receiving first-line treatment.
In October 2016, we announced positive results from CABOSUN, a randomized, open-label, active-controlled phase 2 investigator-sponsored trial (IST) conducted by the Alliance for Clinical Trials in Oncology (the Alliance), comparing cabozantinib with sunitinib in patients with previously untreated advanced RCC with intermediate- or poor-risk disease.
These results were featured in an oral presentation at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February 2025.
In addition, the National Comprehensive Cancer Network (NCCN), the nation’s foremost non-profit alliance of leading cancer centers, has included the combination of CABOMETYX with nivolumab in its Clinical Practice Guidelines for Kidney Cancer as a Category 1 preferred option for the first-line treatment of patients with ccRCC across all risk groups, and as a Category 2A other recommended option for first-line nccRCC.
The NCCN also lists single-agent CABOMETYX as a recommended regimen for patients with previously treated advanced ccRCC, supporting CABOMETYX’s position in the RCC treatment landscape across lines of therapy.

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Gone since FY2025

Risk Factors” below. • Our ability to grow our company is dependent upon the commercial success of CABOMETYX in its approved indications and the continued clinical development, regulatory approval, clinical acceptance and commercial success of the cabozantinib franchise in additional indications. • If we are unable to obtain or maintain coverage and reimbursement for our products from government and other third-party payers, our business will suffer. • Pricing for pharmaceutical products, both in the U.S. and in foreign countries, has come under increasing attention and scrutiny by federal, state and foreign national governments, legislative bodies and enforcement agencies.
Initiatives arising from this scrutiny may result in changes that have the effect of reducing our revenue or harming our business or reputation. • The timing of the entrance of generic competitors to CABOMETYX and legislative and regulatory action designed to reduce barriers to the development, approval and adoption of generic drugs in the U.S. could limit the revenue we derive from our products, most notably CABOMETYX, which could have a material adverse impact on our business, financial condition and results of operations. • We may be unable to expand our discovery and development pipeline, which could limit our growth and revenue potential. • Clinical testing of cabozantinib for new indications, or of our other new product candidates, such as zanzalintinib, is a lengthy, costly, complex and uncertain process that may ultimately fail to demonstrate sufficiently differentiated safety and efficacy data for those products to compete in our highly competitive market environment. • The regulatory approval processes of the U.S.
For example, we rely on Table of C o n t e n t s Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda) for the commercial success of CABOMETYX in its approved indications outside of the U.S., and we are unable to control the amount or timing of resources expended by these collaboration partners in the commercialization of CABOMETYX in its approved indications outside of the U.S.
Fiscal year 2024, which was a 53-week fiscal year, ended on January 3, 2025; fiscal year 2023, which was a 52-week fiscal year, ended on December 29, 2023; and fiscal year 2022, which was a 52-week fiscal year, ended on December 30, 2022.
For convenience, references in this report as of and for the fiscal years ended January 3, 2025, December 29, 2023 and December 30, 2022, are indicated as being as of and for the years ended December 31, 2024, 2023 and 2022, respectively.
In fiscal year 2025, the annual period will end on January 2, 2026 and will be a 52-week fiscal year.
(Exelixis, we, our or us) is an oncology company innovating next-generation medicines and combination regimens at the forefront of cancer care.
We have produced four marketed pharmaceutical products, two of which are formulations of our flagship molecule, cabozantinib, and we are steadily advancing and evolving our product pipeline portfolio, including our lead investigational asset, zanzalintinib, currently the focus of an extensive late-stage clinical development program.
With a rational and disciplined approach to investment, we are leveraging our internal experience and expertise, and the strength of strategic partnerships, to identify and pursue opportunities across the landscape of scientific modalities, including small molecules, biotherapeutics and antibody-drug conjugates (ADCs).
Cabozantinib is an inhibitor of multiple tyrosine kinases, including MET, AXL, VEGF receptors and RET and has been approved by the U.S.
Food and Drug Administration (FDA) and in 67 other countries: as CABOMETYX® (cabozantinib) tablets for advanced renal cell carcinoma (RCC) (both alone and in combination with Bristol-Myers Squibb Company’s (BMS) nivolumab (OPDIVO®)), for previously treated hepatocellular carcinoma (HCC) and for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC); and as COMETRIQ® (cabozantinib) capsules for progressive, metastatic medullary thyroid cancer (MTC).
(a member of the Roche Group) (Genentech); and MINNEBRO® (esaxerenone), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR), approved for the treatment of hypertension in Japan and licensed to Daiichi Sankyo Company, Limited (Daiichi Sankyo).
See “—Collaborations and Business Development Activities—Other Collaborations.” Table of C o n t e n t s 2024 was our eighth consecutive year of annual profitability; it featured growth in net product revenues of approximately 11% year-over-year as a result of increased sales of our cabozantinib products in the U.S., supplemented by an approximately 12% year-over-year increase in royalties earned pursuant to collaboration agreements with our ex-U.S. partners.
We plan to continue leveraging our operating cash flows to advance a broad array of diverse biotherapeutics and small molecule programs for the treatment of cancer, as well as to support ongoing company-sponsored and externally sponsored trials evaluating cabozantinib.
Furthest along in our pipeline is zanzalintinib, a novel, potent, third-generation oral tyrosine kinase inhibitor (TKI) that targets VEGF receptors, MET and the TAM kinases (TYRO3, AXL and MER).
Our zanzalintinib program includes a series of ongoing and planned pivotal trials to explore its therapeutic potential in colorectal cancer (CRC), RCC, non-clear cell (ncc)RCC, squamous cell cancers of the head and neck (SCCHN) and neuroendocrine tumors (NET), as well as earlier-stage trials.
Our other pipeline programs in phase 1 development each have best-in-class potential and include: XL309, a small molecule inhibitor of USP1, which has emerged as a synthetic lethal target in the context of BRCA-mutated tumors; XB010, an ADC consisting of a monomethyl auristatin E (MMAE) payload conjugated to a monoclonal antibody (mAb) targeting the tumor antigen 5T4; and XL495, a small molecule inhibitor of PKMYT1.
We complement our internal drug discovery and development efforts by in-licensing investigational oncology assets or obtaining options to acquire other investigational oncology assets from third parties if they demonstrate evidence of clinical success.
Examples of this approach include XL309 and ADU-1805, a clinical-stage and potentially best-in-class mAb that targets SIRPα.
Exelixis Marketed Products: CABOMETYX and COMETRIQ As detailed below, CABOMETYX and COMETRIQ have been approved to treat patients with various forms of cancer by the FDA for the U.S. market, the European Medicines Agency (EMA) for the European Union (EU) market and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the Japanese market, as well as by comparable regulatory authorities across other markets worldwide.
Table of C o n t e n t s Product Indication Approval Date Regimen Major Markets CABOMETYX® (cabozantinib) Renal Cell Carcinoma (RCC) Patients with advanced RCC who have received prior anti-angiogenic therapy April 25, 2016 Monotherapy U.S.
Advanced RCC in adults following prior VEGF-targeted therapy September 9, 2016 Monotherapy EU Patients with advanced RCC December 19, 2017 Monotherapy U.S.
First-line treatment of adults with intermediate- or poor-risk advanced RCC May 17, 2018 Monotherapy EU Patients with curatively unresectable or metastatic RCC March 25, 2020 Monotherapy Japan First-line treatment of patients with advanced RCC January 22, 2021 Combination with nivolumab U.S.
First-line treatment for patients with advanced RCC March 31, 2021 Combination with nivolumab EU Patients with unresectable or metastatic RCC August 25, 2021 Combination with nivolumab Japan Hepatocellular Carcinoma (HCC) HCC in adults who have previously been treated with sorafenib November 15, 2018 Monotherapy EU Patients with HCC who have been previously treated with sorafenib January 14, 2019 Monotherapy U.S.
Adult patients with locally advanced or metastatic DTC, refractory pr not eligible to RAI who have progressed during or after prior systemic therapy May 3, 2022 Monotherapy EU COMETRIQ® (cabozantinib) Medullary Thyroid Cancer (MTC) Patients with progressive, metastatic MTC November 29, 2012 Monotherapy U.S.
Adult patients with progressive, unresectable locally advanced or metastatic MTC March 25, 2014 Monotherapy EU Table of C o n t e n t s In 2024, 2023 and 2022, we generated $1,809.4 million, $1,628.9 million and $1,401.2 million, respectively, in net product revenues from sales of CABOMETYX and COMETRIQ.
In 2024, 2023 and 2022, we earned $166.9 million, $148.5 million and $121.4 million, respectively, of royalties on net sales of cabozantinib products outside of the U.S.
For additional information on the terms of our collaboration agreements with Ipsen and Takeda, see “—Collaborations and Business Development Activities—Cabozantinib Commercial Collaborations . ” Renal Cell Carcinoma - CABOMETYX is a Leading TKI Treatment Option for Patients with Advanced RCC CABOMETYX has become a standard of care for the treatment of patients with advanced RCC, and a growing number of these patients have been or will be treated with CABOMETYX.
In 2024, approximately 33,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 21,000 patients receiving first-line treatment.
In October 2016, we announced positive results from CABOSUN, a randomized, open-label, active-controlled phase 2 trial conducted by the Alliance for Clinical Trials in Oncology (the Alliance), comparing cabozantinib with sunitinib in patients with previously untreated advanced RCC with intermediate- or poor-risk disease.
These updated results will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February 2025 (ASCO GU 2025).
In addition, the National Comprehensive Cancer Network (NCCN), the nation’s foremost non-profit alliance of leading cancer centers, has included the combination of CABOMETYX with nivolumab in its Clinical Practice Guidelines for Kidney Cancer as a Category 1 preferred option for the first-line treatment of patients with clear cell RCC across all risk groups, and as a Category 2A other recommended option for first-line nccRCC.
The NCCN also lists single-agent CABOMETYX as a recommended regimen for patients with previously treated advanced clear cell RCC, supporting CABOMETYX’s position in the RCC treatment landscape across lines of therapy.
In 2024, in markets outside the U.S., we continued to work closely with our collaboration partner Ipsen in support of its regulatory strategy and commercialization efforts for CABOMETYX, both as a single agent and in combination with nivolumab, as well as in preparation for submission of applications for potential additional approvals of CABOMETYX, and similarly with our collaboration partner Takeda with respect to the Japanese market.
As a result of the approvals of CABOMETYX and/or the combination of CABOMETYX with nivolumab for RCC indications in 67 countries outside of the U.S., including the Member States of the EU, Japan, the U.K., Canada, Brazil, Taiwan, South Korea, Australia and Hong Kong, Table of C o n t e n t s CABOMETYX has continued to grow markedly outside the U.S. both in sales revenue and the number of RCC patients benefiting from its clinical effect.
Although HCC is the most common form of liver cancer, making up about three-fourths of the more than 42,200 cases of liver cancer estimated to be diagnosed in the U.S. during 2025, this patient population has long been underserved.
Biopharmaceutical companies have since developed new and demonstrably more effective therapies for previously untreated patients, including ICI combination therapies.
These new treatment options have improved longer-term outcomes for HCC patients, thereby resulting in a greater number of them receiving multiple lines of therapy.
The FDA approved the HCC indication for CABOMETYX in January 2019 was based on our phase 3 pivotal study, CELESTIAL.
Outside the U.S., the EMA’s approval of CABOMETYX provided physicians in the EU with a second approved therapy for the second-line treatment of this aggressive and difficult-to-treat cancer, and approvals from Health Canada and the Japanese PMDA brought a much-needed treatment option to HCC patients in those countries.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2025 ↗, FY2026 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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