Exelixis, Inc.

Overview

Exelixis is an oncology-focused biopharmaceutical company that develops, markets, and collaborates on cancer therapies. Its commercial business is driven by the cabozantinib franchise, and the company advances a pipeline of small molecules and biotherapeutics through internal programs and partnered collaborations. Development, manufacturing, and post-market activities are largely conducted with third-party contract manufacturers and commercial partners.

Core products and indications

• CABOMETYX (cabozantinib)
  • Renal cell carcinoma (advanced; first-line and subsequent lines, as monotherapy and in combination with nivolumab)
  • Hepatocellular carcinoma (previously treated)
  • Differentiated thyroid cancer (previously treated or refractory)
  • Pancreatic and extra-pancreatic neuroendocrine tumors (pNET and epNET)
  • Ongoing development for additional indications and combinations with immune checkpoint inhibitors
• COMETRIQ (cabozantinib, capsule)
  • Progressive, metastatic medullary thyroid cancer (MTC)
• Commercialization outside the U.S./Japan
  • Ipsen: most non-U.S. markets (excluding Japan) with co-development/co-promotion in select indications
  • Takeda: Japan

Lead clinical program — zanzalintinib

• Oral kinase inhibitor targeting TAM kinases (TYRO3, AXL, MER) as well as MET and VEGF receptors
• Pivotal and registrational trials underway in:
  • Colorectal cancer (metastatic, non-MSI-H/dMMR; STELLAR-303)
  • Renal cell carcinoma (nccRCC; STELLAR-304)
  • Neuroendocrine tumors (STELLAR-311)
  • Other indications including meningioma
• Development plans include monotherapy and combinations with immune checkpoint inhibitors (atezolizumab, nivolumab, etc.)
• NDA for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer was submitted in December 2025; FDA accepted the NDA with a PDUFA target date of December 3, 2026.

Pipeline highlights

• Small molecules and biotherapeutics, including internally developed and in-licensed programs:
  • XL309 (USP1 inhibitor)
  • XB010 (ADC targeting 5T4)
  • XB628 (PD-L1/NKG2A bispecific)
  • XB371 (TF-targeting ADC)
  • ADU-1805 (SIRPα-targeting antibody; collaboration with Sairopa)
• Additional discovery and platform collaborations support ADCs, multispecific antibodies, and other modalities.

Financial highlights

• Net product revenues:
  • 2025: $2,122.8 million
  • 2024: $1,809.4 million
  • 2023: $1,628.9 million
• Royalties (outside the U.S. for cabozantinib):
  • 2025: $179.2 million
  • 2024: $166.9 million
  • 2023: $148.5 million
• Profitability: 2025 was the company’s ninth consecutive year of annual profitability.

Commercial and manufacturing operations

• U.S. commercial model: Exelixis markets CABOMETYX and COMETRIQ directly via an integrated commercial team.
• International commercialization: Ipsen and Takeda manage distribution and commercialization under collaboration agreements.
• Patient support: Exelixis operates the EASE patient access program for co-pay assistance and reimbursement support.
• Manufacturing and supply: CMC development, clinical, and commercial production are performed by third-party contract manufacturers; cabozantinib-related manufacturing is coordinated with collaboration partners.
• Pharmacovigilance: A global safety database is maintained, with safety reporting responsibilities shared with Ipsen and Takeda for non-U.S. territories.
• Regulatory approvals: CABOMETYX and COMETRIQ are approved in the U.S., EU/EEA, U.K., Japan, and other markets, with region-specific labeling and post-marketing obligations.

Strategic collaborations and business development

• Cabozantinib commercialization and development partners:
  • Ipsen: exclusive non-U.S. rights outside the U.S., Canada, and Japan; co-development and cost-sharing in select trials
  • Takeda: exclusive rights in Japan; collaboration on Japan-specific development and commercialization
  • Bristol Myers Squibb (BMS): collaborations on cabozantinib with nivolumab and/or ipilimumab
  • Roche/Genentech: combination studies with atezolizumab and joint clinical research agreements
• Zanzalintinib and discovery collaborations: partnerships with Roche, Merck (MSD), BMS, Genentech, Invenra, Sairopa, Insilico Medicine, Catalyst, and others for combination trials and discovery efforts
• Additional collaborations:
  • Insilico (XL309 license), Sairopa (ADU-1805), Adagene (SAFEbody technology), Catalent (SMARTag ADC platform), Invenra (multispecific antibodies), Iconic (TF-targeting antibodies), Basecamp Bio (SSTR2 acquisition)
• Cooperative agreements and external trials: NCI-CTEP CRADA and alliance-led STELLAR trials expand development and evidence generation.

Competitive landscape and intellectual property

• Cabozantinib competes with approved therapies and late-stage programs across RCC, HCC, DTC, pNET/epNET, and MTC indications.
• Exelixis holds multiple cabozantinib patents in the U.S. and other jurisdictions, with Orange Book listings and expirations through the 2020s and 2030s.
• The company faces generic competition risk and ongoing patent litigation and IP challenges related to cabozantinib.

Regulatory and policy environment

• Ongoing regulatory requirements apply for approvals, labeling, manufacturing controls, and post-marketing safety reporting in the U.S. and globally.
• U.S. healthcare policy, pricing, and reimbursement changes (including provisions under the Inflation Reduction Act and Part D discussions) may affect coverage and net revenues.
• EU regulatory reforms, including potential changes to orphan designations and HTA processes, could influence timelines and market access in Europe.
• The company maintains compliance programs for privacy, data security, and anti-kickback/false claims regulations.