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Exelixis financial results FY2025 highlight revenue growth and oncology pipeline progress
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Exelixis Reports Strong FY2025 Financial Results, Sets Stage for Pivotal 2026

Exelixis reports strong FY2025 earnings as cabozantinib sales grow and key oncology trials set the stage for 2026.

Introduction

Exelixis has closed fiscal year 2025 with strong financial performance, underpinned by sustained growth in its cabozantinib franchise and disciplined operational execution. The oncology-focused biopharmaceutical company reported solid revenue expansion, rising earnings, and meaningful pipeline advancement, positioning itself for what management describes as a potential breakout year in 2026. For investors, healthcare executives, and industry stakeholders, Exelixis’ latest financial results offer valuable insight into how mature oncology assets can fund next-generation innovation while maintaining profitability.

This article breaks down Exelixis fourth quarter and full-year 2025 financial results, highlights the performance of its core products, examines pipeline progress led by zanzalintinib, and explains what the company’s guidance signals for the year ahead.

Exelixis Financial Results for Q4 and FY2025

Exelixis reported total revenues of $598.7 million for the fourth quarter of 2025, bringing full-year revenues to $2.320 billion. This marked a notable increase from $2.168 billion in 2024, reflecting higher sales volumes of its flagship oncology therapies and continued demand across approved indications.

Key Financial Highlights

  • Fourth quarter revenue of $599 million
  • Fiscal year 2025 revenue of $2.320 billion
  • Net product revenues of $2.123 billion for the year
  • GAAP diluted earnings per share of $2.78 for FY2025
  • Non-GAAP diluted earnings per share of $3.08 for FY2025

Revenue growth was primarily driven by increased utilization of cabozantinib-based therapies in the U.S. market, particularly in renal cell carcinoma and neuroendocrine tumors.

Cabozantinib Franchise Remains the Core Growth Engine

Cabozantinib, marketed as CABOMETYX and COMETRIQ, continued to serve as Exelixis’ primary commercial driver in 2025. U.S. net product revenues from the franchise reached $2.123 billion for the year, up significantly from the prior year, while global cabozantinib revenues generated by Exelixis and its partners approached $2.9 billion.

What Is Driving Cabozantinib Growth

Strong performance was supported by several factors:

  • Expanded clinical adoption in renal cell carcinoma
  • Increased utilization following FDA approvals in neuroendocrine tumors
  • Favorable treatment positioning supported by real-world evidence
  • Continued physician confidence in the drug’s safety and efficacy profile

Exelixis also benefited from royalty revenues generated by its international partners Ipsen and Takeda, reinforcing the durability of the cabozantinib franchise beyond the U.S. market.

Improving Profitability and Cost Discipline

While revenue growth stood out, Exelixis also demonstrated cost discipline across key expense categories. Research and development spending declined year over year as late-stage trial costs normalized, while selling, general, and administrative expenses remained well controlled relative to revenue growth.

GAAP net income for FY2025 reached $782.6 million, compared with $521.3 million in 2024. This improvement highlights Exelixis’ ability to balance investment in innovation with shareholder returns, a key metric for long-term institutional investors.

Zanzalintinib Pipeline Signals the Next Growth Phase

Beyond its marketed products, Exelixis’ long-term value proposition increasingly rests on zanzalintinib, a next-generation oral kinase inhibitor designed to address multiple oncology indications. In 2025 and early 2026, the company achieved several critical milestones that advanced the program toward potential commercialization.

Regulatory Progress in Colorectal Cancer

In February 2026, the U.S. Food and Drug Administration accepted Exelixis’ New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer. The application is supported by positive results from the STELLAR-303 phase 3 trial, which demonstrated a statistically significant overall survival benefit compared with standard therapy.

A regulatory decision is expected by December 2026, making this one of the most closely watched oncology approvals of the year.

Major Clinical Milestones Expected in 2026

Exelixis has outlined a milestone-rich roadmap for 2026 that could materially reshape its growth trajectory.

Key Trials to Watch

  • Final overall survival analysis from STELLAR-303
  • Topline data from STELLAR-304 in non-clear cell renal cell carcinoma
  • Initiation of STELLAR-316 in molecular residual disease-positive colorectal cancer
  • Launch of STELLAR-201 in recurrent meningioma

Collectively, these trials position zanzalintinib as a potential multi-indication oncology franchise rather than a single-asset product.

Strategic Collaborations Strengthen Development Capabilities

Exelixis continues to leverage partnerships to accelerate clinical development and expand scientific reach. A notable collaboration with Natera will integrate circulating tumor DNA testing into the STELLAR-316 trial, enabling more precise patient selection and potentially stronger outcomes.

In parallel, Merck has initiated a pivotal phase 3 trial evaluating zanzalintinib in combination with belzutifan in advanced renal cell carcinoma, underscoring external validation of the molecule’s potential.

Capital Allocation and Shareholder Returns

Exelixis has paired its operational success with an aggressive capital return strategy. In 2025, the company completed a $500 million stock repurchase program and launched an additional $750 million authorization extending into 2026.

Since 2023, Exelixis has repurchased over $2.1 billion worth of shares, reducing its outstanding share count and enhancing earnings per share growth for long-term investors.

2026 Financial Guidance Overview

Exelixis reaffirmed its previously issued guidance for fiscal year 2026, excluding any potential revenue from a zanzalintinib approval in colorectal cancer.

2026 Guidance Highlights

  • Total revenue expected between $2.525 billion and $2.625 billion
  • Net product revenue forecast of $2.325 billion to $2.425 billion
  • Research and development spending projected at $875 million to $925 million
  • Effective tax rate anticipated between 21 percent and 23 percent

The guidance reflects confidence in continued cabozantinib growth while funding a robust clinical pipeline.

What This Means for Business Leaders and Investors

For business professionals evaluating the oncology sector, Exelixis offers a case study in sustainable biotech growth. The company has successfully monetized a mature oncology asset while reinvesting proceeds into a diversified pipeline with multiple shots on goal.

Key takeaways include disciplined capital allocation, strong execution in late-stage development, and a clear path to future revenue diversification. If zanzalintinib secures regulatory approval, Exelixis could significantly expand its addressable market and reduce dependence on a single franchise.

Conclusion

Exelixis’ 2025 financial results highlight a company operating from a position of strength. With growing revenues, expanding margins, and a deep clinical pipeline approaching pivotal inflection points, Exelixis is entering 2026 with momentum. For investors and industry stakeholders, the coming year will be critical in determining whether the company can successfully transition from a single-franchise oncology firm to a multi-franchise growth platform.