8-K: Exelixis Reports Strong FY25, Boosts 2026 Guidance

Exelixis announced preliminary unaudited fiscal year 2025 financial results, provided robust financial guidance for fiscal year 2026, and outlined key strategic priorities and pipeline milestones.

Summary

• Preliminary unaudited fiscal year 2025 total revenues were approximately $2.320 billion.
• Preliminary unaudited fiscal year 2025 U.S. net product revenues reached approximately $2.123 billion, primarily driven by the Cabozantinib franchise.
• Fiscal year 2026 total revenues guidance is set between $2.525 billion and $2.625 billion.
• Fiscal year 2026 net product revenues guidance is projected to be $2.325 billion to $2.425 billion, which includes a 3.0% U.S. wholesale acquisition cost increase for CABOMETYX and COMETRIQ effective January 1, 2026.
• Research and development expenses for fiscal year 2026 are guided to be $875 million to $925 million, including $50.0 million of non-cash stock-based compensation.
• Selling, general and administrative expenses for fiscal year 2026 are guided to be $575 million to $625 million, including $75.0 million of non-cash stock-based compensation.
• Ending cash and marketable securities for fiscal year 2025 were approximately $1.65 billion.
• The company anticipates 2026 to be a significant year for clinical, regulatory, and commercial progress, aiming to build a potential second commercial franchise with zanzalintinib.
• A U.S. regulatory review is ongoing for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer (CRC).
• The final analysis for STELLAR-303's dual primary endpoint (overall survival in patients without liver metastases) is expected in mid-2026.
• Topline results for STELLAR-304, evaluating zanzalintinib in advanced non-clear cell renal cell carcinoma (RCC), are anticipated in mid-2026.
• Active patient enrollment continues for the phase 2/3 STELLAR-311 pivotal trial of zanzalintinib in advanced neuroendocrine tumors (NET).
• The LITESPARK-033 trial, evaluating zanzalintinib and WELIREG in first-line advanced RCC, was initiated in December 2025.
• Planned initiation of STELLAR-316 (adjuvant CRC) and STELLAR-201 (recurrent meningioma) trials is expected in mid-2026.
• Four Phase 1 clinical programs (XL309, XB010, XB628, XB371) are advancing, with plans for full development if data are supportive.
• Two potential Investigational New Drug (IND) applications are anticipated in 2026 for XL557 (Somatostatin Receptor 2 agonist) and XB773 (DLL3-targeting ADC).
• Since March 2023, Exelixis has repurchased $2.16 billion of its common stock, retiring 76.7 million shares at an average price of $28.14 per share.
• An additional $750 million stock repurchase program was authorized in October 2025, to be completed by December 31, 2026.

Sentiment

Score: 8

Explanation: The filing presents a very positive outlook with strong preliminary financial results for FY25, robust growth guidance for FY26, significant pipeline advancements, and a clear strategy for future growth and shareholder returns. The potential for a second commercial franchise with zanzalintinib and multiple ongoing pivotal trials contribute to a strong positive sentiment, despite the preliminary nature of some financial data.

Positives

• Strong preliminary fiscal year 2025 financial performance with Cabozantinib franchise achieving approximately $2.123 billion in U.S. net product revenues.
• Robust fiscal year 2026 financial guidance with projected total revenues of $2.525 billion $2.625 billion and net product revenues of $2.325 billion $2.425 billion, indicating continued growth.
• Significant cash and marketable securities balance of approximately $1.65 billion at the end of fiscal year 2025, providing financial flexibility.
• Cabozantinib maintains market leadership as the number one TKI monotherapy and most prescribed TKI in combination with immunotherapy in RCC, and shows accelerating uptake in NET.
• Positive pivotal data readout and U.S. regulatory filing for zanzalintinib in previously treated metastatic CRC, representing a potential second commercial franchise.
• Expansion of the zanzalintinib pivotal trial program with multiple ongoing and planned studies (STELLAR-303, -304, -311, LITESPARK-033, STELLAR-316, STELLAR-201) targeting various oncology indications.
• Advancement of early-stage pipeline with four Phase 1 programs and two anticipated IND applications in 2026 (XL557, XB773), demonstrating a robust R&D engine.
• Commitment to shareholder returns through an ongoing stock repurchase program, with an additional $750 million authorized for repurchase by December 31, 2026.
• Strategic goal to become a top-5 solid tumor oncology company and build next-generation oncology franchises, indicating clear long-term vision and growth ambition.

Negatives

• Preliminary financial results for fiscal year 2025 are unaudited and subject to change, with full audited results planned for release on February 10, 2026.
• The U.S. regulatory approval and commercial launch of zanzalintinib for CRC are not currently reflected in the 2026 revenue guidance, suggesting potential conservatism or uncertainty regarding timing and impact.
• The prespecified interim analysis of STELLAR-303's second dual primary endpoint (OS in patients without liver metastases) showed only a 'trend favoring the combination' and was immature at the data cutoff, with final analysis still pending in mid-2026.

Risks

• The degree of market acceptance of CABOMETYX and other Exelixis products in approved indications and territories.
• Exelixis' and its partners' ability to obtain or maintain coverage and reimbursement for these products.
• The effectiveness of CABOMETYX and other Exelixis products in comparison to competing products.
• Complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere.
• The level of costs associated with Exelixis' commercialization, research and development, in-licensing or acquisition of product candidates, and other activities.
• Exelixis' ability to maintain and scale adequate sales, marketing, market access, and product distribution capabilities or to enter into and maintain agreements with third parties to do so.
• The availability of data at the referenced times.
• The potential failure of cabozantinib, zanzalintinib, and other Exelixis product candidates, both alone and in combination with other therapies, to demonstrate safety and/or efficacy in clinical testing.
• Uncertainties inherent in the drug discovery and product development process.
• Exelixis' dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals, adherence to obligations, and investment levels.
• Exelixis' continuing compliance with applicable legal and regulatory requirements.
• Unexpected concerns that may arise as a result of adverse safety events or additional data analyses of clinical trials.
• Exelixis' dependence on third-party vendors for the development, manufacture, and supply of its products and product candidates.
• Exelixis' ability to protect its intellectual property rights.
• Market competition, including the potential for competitors to obtain approval for generic versions of Exelixis' marketed products.
• Changes in economic and business conditions, including as a result of changing trade policies and tariffs and the related uncertainty thereof.

Future Outlook

Exelixis anticipates 2026 to be a significant year of clinical, regulatory, and commercial progress, driven by the continued growth of its cabozantinib business and the potential launch of zanzalintinib as a second commercial franchise. The company aims to become a top-5 solid tumor oncology company by leveraging its diverse pipeline and strategic collaborations to build next-generation oncology franchises, improve standards of care, and drive sustained nearto mid-term growth while returning capital to shareholders.

Management Comments

• "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." 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." Michael M. Morrissey, Ph.D., President & CEO, Exelixis.
• "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." Michael M. Morrissey, Ph.D., President & CEO, Exelixis.
• "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." Michael M. Morrissey, Ph.D., President & CEO, Exelixis.
• "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." Michael M. Morrissey, Ph.D., President & CEO, Exelixis.
• "Through careful prioritization and disciplined investments in high-value opportunities, we are confident we can drive sustained nearto mid-term growth while returning capital to shareholders and improving the standards of care for patients with cancer." Michael M. Morrissey, Ph.D., President & CEO, Exelixis.

Industry Context

Exelixis operates in the highly competitive oncology market, focusing on solid tumors. The company's strategy to expand its cabozantinib franchise and develop zanzalintinib into a second commercial franchise aligns with industry trends towards multi-indication therapies and combination regimens to improve patient outcomes. Its focus on renal cell carcinoma, neuroendocrine tumors, and colorectal cancer addresses significant unmet medical needs, positioning it against major pharmaceutical players in these therapeutic areas. The emphasis on novel small molecules and biotherapeutics, including ADCs and bispecifics, reflects the broader industry shift towards targeted and precision oncology.

Comparison to Industry Standards

• The filing does not provide specific comparable companies, projects, or results for direct assessment against global benchmarks.
• Exelixis' stated goal to become a 'top-5 solid tumor oncology company' implies an ambition to compete with leading global oncology firms.
• The company's strategy of building multi-franchise approaches in RCC, NET, and CRC, and advancing a diverse pipeline, is consistent with the strategies of major pharmaceutical companies seeking to establish broad market presence and leadership in oncology.

Stakeholder Impact

• Shareholders: Potential for increased value through strong financial performance, pipeline growth, and ongoing stock repurchase program.
• Patients: Potential for new and improved treatment options for various cancers (RCC, NET, CRC, meningioma) through pipeline advancements and regulatory approvals.
• Employees: Expansion of the GI sales team indicates potential for new roles and growth opportunities.
• Collaboration Partners (e.g., Merck, Natera): Continued collaboration on clinical trials and patient identification.

Next Steps

• Exelixis presentation and webcast at the J.P. Morgan 2026 Healthcare Conference on January 12, 2026.
• Release of audited financial results for fiscal year 2025 on February 10, 2026.
• Ongoing U.S. regulatory review for zanzalintinib in previously treated metastatic colorectal cancer (CRC) in combination with atezolizumab.
• Final analysis for STELLAR-303's overall survival (OS) in patients without liver metastases endpoint expected mid-2026.
• Topline results for STELLAR-304 anticipated mid-2026.
• Continued active enrollment in the phase 2/3 STELLAR-311 pivotal trial.
• Anticipated initiation of a second Merck-sponsored pivotal trial of zanzalintinib and belzutifan in RCC in early 2026.
• Expected initiation of STELLAR-316 (adjuvant CRC) in mid-2026.
• Expected initiation of STELLAR-201 (recurrent meningioma) in mid-2026, with a confirmatory phase 3 study also planned.
• Progression of XL309, XB010, XB628, and XB371 into full development if Phase 1 data are supportive.
• Advancement of XL557 and XB773 into clinical development (IND applications) in 2026.
• Continued execution of the stock repurchase program through December 31, 2026.

Key Dates

Recommendation

The filing demonstrates robust preliminary financial performance for FY25 and provides strong growth guidance for FY26, driven by the continued success of the Cabozantinib franchise. The company is strategically positioned for future growth with a promising pipeline, particularly with zanzalintinib nearing potential commercialization as a second franchise and multiple pivotal trials underway. The substantial cash reserves and ongoing stock repurchase program further enhance shareholder value. While preliminary results are unaudited, the overall trajectory and strategic initiatives outlined suggest significant upside potential for investors.

Keywords

Exelixis, EXEL, oncology, cancer, biotechnology, pharmaceuticals, CABOMETYX, cabozantinib, zanzalintinib, renal cell carcinoma, neuroendocrine tumors, colorectal cancer, pipeline, financial guidance, stock repurchase, FDA, clinical trials, drug development, small molecules, biotherapeutics, ADC, IND