10-K: Exelixis Reports Strong 2025, Advances Oncology Pipeline

Exelixis, Inc. announced robust financial results for 2025, driven by strong CABOMETYX sales and significant progress in its diverse oncology pipeline, including a zanzalintinib NDA submission.

Summary

• Net product revenues for 2025 increased by 17% year-over-year to $2,122.8 million.
• Total revenues for 2025 reached $2,320.1 million, a 7% increase compared to 2024.
• Net income for 2025 was $782.6 million, or $2.88 per basic share, up from $521.3 million ($1.80 per basic share) in 2024.
• CABOMETYX sales increased by 18% to $2,113.369 million, primarily due to demand in advanced Renal Cell Carcinoma (RCC) in combination with nivolumab and previously treated advanced Neuroendocrine Tumors (NET).
• Royalties earned from ex-U.S. partners increased by approximately 7% year-over-year.
• The FDA approved CABOMETYX for previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and extra-pancreatic neuroendocrine tumors (epNET) in March 2025.
• Ipsen, a collaboration partner, received EU approval for CABOMETYX in pNET/epNET in July 2025.
• A New Drug Application (NDA) was submitted to the FDA for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer (CRC) in December 2025, with a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026.
• The XL495 development program was discontinued in May 2025 based on early clinical data.
• The STELLAR-305 trial (zanzalintinib + pembrolizumab in head and neck cancer) will not proceed to Phase 3 due to emerging Phase 2 data, competition, and other commercial opportunities.
• An Amended and Restated Collaboration and License Agreement with Ipsen was entered into on December 17, 2025, modifying pharmacovigilance cost reimbursements.
• A Fourth Amendment to the Collaboration and License Agreement with Takeda was executed on November 21, 2025, granting Exelixis rights to develop and commercialize a competing product in Japan and modifying cost-sharing and milestone payments.

Sentiment

Score: 8

Explanation: StockSavvy.ai views this as a strong performance, marked by significant revenue and net income growth, successful label expansions for CABOMETYX, and promising pipeline advancements with zanzalintinib, despite some clinical program discontinuations. The company's strategic collaborations and robust cash position further support a positive outlook.

Positives

• Net product revenues grew by 17% year-over-year to $2,122.8 million in 2025, indicating strong market demand for existing products.
• Net income significantly increased to $782.6 million in 2025 from $521.3 million in 2024, demonstrating enhanced profitability.
• CABOMETYX sales rose by 18% to $2,113.369 million, driven by continued adoption in advanced RCC (especially in combination with nivolumab) and the new indication for previously treated advanced NET.
• FDA approval of CABOMETYX for previously treated advanced pNET and epNET in March 2025 expands the product's market reach and therapeutic utility.
• Positive top-line results from the STELLAR-303 trial for zanzalintinib in combination with atezolizumab in metastatic CRC, showing a statistically significant improvement in overall survival (OS) in the ITT population.
• The NDA submission for zanzalintinib in combination with atezolizumab for previously treated metastatic CRC was accepted by the FDA, with a PDUFA target action date of December 3, 2026, signaling potential near-term pipeline expansion.
• Ipsen's receipt of EU approval for CABOMETYX in pNET/epNET in July 2025 further extends the product's global commercial footprint.
• Royalties from ex-U.S. partners increased by approximately 7%, reflecting successful international commercialization efforts.
• A strong cash position of $1.66 billion in cash, cash equivalents, and marketable securities as of December 31, 2025, provides financial flexibility for future investments.
• Qualified for the small biotech exception for the Medicare Drug Price Negotiation Program through 2027 for cabozantinib products, potentially mitigating future pricing pressures.
• Eligible for a phase-in of increased manufacturer discounts under the Medicare Part D Manufacturer Discount Program from 2025 to 2031.
• The Board authorized an additional $750 million stock repurchase program through December 31, 2026, indicating confidence in the company's valuation and commitment to shareholder returns.

Negatives

• Collaboration services revenues decreased significantly by 269% to $(17.053) million in 2025, primarily due to lower development cost reimbursements and increased royalty payments to Royalty Pharma.
• License revenues decreased by 39% to $214.375 million in 2025, mainly attributable to lower milestone achievements compared to 2024.
• The XL495 development program was discontinued in May 2025 due to early clinical data, representing a setback in the pipeline.
• The STELLAR-305 trial for zanzalintinib in head and neck cancer will not proceed to Phase 3, indicating a failure for that specific indication due to emerging Phase 2 data and competitive landscape.
• The final analysis for CONTACT-02 (cabozantinib + atezolizumab in mCRPC) showed a trend favoring the combination for OS but was not statistically significant, leading to the decision not to file a supplemental New Drug Application (sNDA).
• Research and development expenses decreased by 9% to $825.0 million, partly due to lower development milestone achievement and manufacturing costs, which could suggest reduced investment in certain R&D areas.
• Interest income decreased by 10% due to lower average interest-bearing investment balances and lower average interest rates.
• Working capital decreased by 2% to $1,037.645 million, primarily influenced by cash payments for stock repurchases.

Risks

• Ability to grow 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.
• Inability to obtain or maintain coverage and reimbursement for products from government and other third-party payers could adversely affect business.
• Current healthcare laws, policies, and regulations in the U.S. and future legislative or regulatory reforms, including those related to drug pricing (e.g., Inflation Reduction Act of 2022, most favored nation pricing), may reduce revenue or harm business.
• The timing of generic competitors' entrance to CABOMETYX and legislative/regulatory actions designed to reduce barriers to generic drug development, approval, and adoption could limit revenue.
• Inability to expand the discovery and development pipeline could limit growth and revenue potential.
• Clinical testing of product candidates is a lengthy, costly, complex, and uncertain process that may ultimately fail to demonstrate sufficiently differentiated safety and efficacy data.
• Regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, uncertain, and subject to change, potentially not resulting in approvals for additional indications or product candidates.
• Profitability could be negatively impacted if expenses associated with drug discovery, clinical development, business development, and commercialization activities grow more quickly than revenues.
• Reliance on collaboration partners (Ipsen, Takeda, BMS, Roche, Merck, Natera, Insilico, Sairopa, Basecamp Bio, Catalent, Adagene, Iconic, Invenra) for continued performance and investments, with limited control over their resource allocation, poses risks.
• Subject to healthcare laws, regulations, and enforcement, as well as privacy, data collection, and processing laws; failure to comply could have a material adverse impact.
• Data breaches and other cybersecurity incidents impacting information technology operations and infrastructure could compromise intellectual property or other sensitive information, damage operations, and harm business and reputation.
• Inability to adequately protect intellectual property could allow third parties to use technology, adversely affecting competitiveness.
• Loss of key personnel or inability to retain and attract additional personnel could impair successful operation.
• Risks related to environmental, social, and governance (ESG) matters, including market perception and stock price.
• Potential product liability exposure far in excess of limited insurance coverage.
• Stock price has been and may in the future be highly volatile due to various factors, including regulatory announcements, clinical trial results, competition, and macroeconomic conditions.
• Anti-takeover provisions in charter documents and under Delaware law could make an acquisition more difficult and may prevent or deter attempts by stockholders to replace or remove current management.
• Ongoing patent litigation with generic manufacturers (MSN, Azurity, Handa) could result in generic versions of cabozantinib entering the market before patent expiration, significantly decreasing revenues.
• Potential negative rulings in 340B Program administrative dispute resolution (ADR) proceedings or state-level proceedings regarding the 340B Program Integrity Initiative could materially adversely affect business.

Future Outlook

Exelixis anticipates net product revenues to increase in fiscal year 2026, driven by continued demand for CABOMETYX in combination with nivolumab for first-line advanced RCC and previously treated advanced NET. Research and development expenses are projected to increase in fiscal year 2026 due to higher clinical trial costs for zanzalintinib, XB628, XB371, and XB010, as well as personnel expenses. The company expects to progress up to two new development candidates into preclinical development and advance XB773 and an SSTR2 agonist program toward potential IND filings in 2026. Top-line results for STELLAR-304 (nccRCC) and the final analysis for STELLAR-303 (CRC, OS in patients without liver metastases) are expected in mid-2026, with new trials (STELLAR-201, STELLAR-316) anticipated to commence in the first half and mid-2026, respectively. The effective tax rate is projected to be between 21% and 23% in fiscal year 2026, and the company intends to maintain its small biotech exception for cabozantinib products under the Medicare Drug Price Negotiation Program through 2030.

Management Comments

• "In Ipsen, Exelixis has an ideal partner to maximize the potential for cabozantinib to have a positive impact on the treatment of cancer on a global basis." Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis.
• "Ipsen's established international oncology marketing presence, late-stage clinical development expertise and shared vision with Exelixis for the franchise potential of cabozantinib will accelerate cabozantinib's commercialization in its territories, while Exelixis remains focused on our launch in the United States." Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis.
• "While our immediate priority will be on advanced renal cell carcinoma, Exelixis and Ipsen are committed to exploring and potentially developing cabozantinib in a variety of cancer settings." Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis.
• "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." Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis.
• "We will continue to engage in pipeline expansion initiatives with the goal of discovering, acquiring and/or in-licensing promising investigational oncology assets and then further characterize and develop them utilizing our established preclinical and clinical development infrastructure." Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis.

Industry Context

StockSavvy.ai notes that Exelixis' strong performance in 2025, particularly with CABOMETYX, positions it well within the competitive oncology market. The expansion of CABOMETYX into pNET/epNET and the NDA submission for zanzalintinib in CRC demonstrate a strategic focus on diversifying its oncology portfolio beyond its flagship product. The increasing adoption of ICI and ICI-TKI combination therapies in RCC and HCC, as noted in the filing, reflects a broader industry trend towards combination regimens, which Exelixis is actively addressing through its clinical development programs for both cabozantinib and zanzalintinib. The discontinuation of XL495 and STELLAR-305 highlights the inherent risks and high attrition rates in drug development, a common challenge across the biopharmaceutical industry. The company's emphasis on in-licensing and strategic collaborations for its early-stage pipeline aligns with a common industry strategy to mitigate R&D costs and risks while expanding therapeutic modalities like ADCs and bispecific antibodies.

Comparison to Industry Standards

• CABOMETYX is the only single-agent therapy approved in the U.S. for previously treated advanced RCC to demonstrate statistically significant and clinically meaningful improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in a global pivotal trial (METEOR), differentiating it from other VEGFR TKIs.
• For previously untreated advanced RCC with intermediateor poor-risk disease, CABOMETYX is the only approved single-agent therapy to demonstrate improved PFS compared with sunitinib (CABOSUN trial), a first-generation TKI.
• The combination of CABOMETYX and nivolumab (CheckMate -9ER) doubled PFS and ORR and reduced the risk of disease progression or death by 40% compared with sunitinib in first-line advanced RCC, demonstrating superior efficacy.
• The National Comprehensive Cancer Network (NCCN) includes the combination of CABOMETYX with nivolumab as a Category 1 preferred option for first-line ccRCC across all risk groups, and single-agent CABOMETYX as a recommended regimen for previously treated advanced ccRCC, indicating strong clinical endorsement compared to other available therapies.
• Zanzalintinib's preliminary clinical activity in STELLAR-001 was noted as 'similar to that observed with cabozantinib,' suggesting a potentially competitive profile within the TKI class.
• The STELLAR-303 trial for zanzalintinib in combination with atezolizumab demonstrated a statistically significant improvement in OS versus regorafenib in metastatic, refractory non-MSI-H/dMMR CRC, positioning it favorably against an established standard of care.

Management Changes

Corporate Governance

Legal Proceedings

• Ongoing patent infringement lawsuits against MSN Pharmaceuticals, Inc. regarding Abbreviated New Drug Applications (ANDAs) for generic versions of CABOMETYX tablets. Previous rulings rejected MSN's invalidity challenges to several patents, with final FDA approval for MSN's ANDA not before August 14, 2026, for some patents and January 15, 2030, for others. MSN has appealed to the Court of Appeals for the Federal Circuit.
• Patent infringement lawsuit against Azurity Pharmaceuticals, Inc. regarding a 505(b)(2) New Drug Application for cabozantinib tablets. This litigation has been consolidated with the MSN litigation for a trial scheduled for November 2, 2026.
• A settlement agreement was reached with Sun Pharmaceutical Industries Ltd. in December 2025, terminating all ongoing Hatch-Waxman litigation between Exelixis and Sun regarding CABOMETYX patents.
• Received a notice letter in November 2025 regarding a 505(b)(2) New Drug Application submitted by Handa Oncology, LLC, requesting approval to market cabozantinib capsules (lauryl sulfate form). Exelixis is evaluating all legal and strategic options.
• Received a 340B Program Administrative Dispute Resolution (ADR) petition in November 2023 from several covered entities, alleging overcharges for CABOMETYX and COMETRIQ due to Exelixis' 340B Program Integrity Initiative. The HRSA will assign an ADR panel.
• Received notice letters from the West Virginia Board of Pharmacy in March-May 2025 regarding complaints for purported violations of laws related to drug distribution to 340B facilities.

Stakeholder Impact

• Shareholders: Positive financial results, new drug approvals, and pipeline advancements could lead to increased shareholder value. The stock repurchase program also directly benefits shareholders. However, ongoing patent litigation and regulatory changes (e.g., IRA) pose potential risks to future returns.
• Employees: The 2025 corporate reorganization plan involved workforce reorganization and an office closure. The company emphasizes competitive compensation, comprehensive benefits, and career development programs to attract and retain high-quality talent.
• Patients: New FDA approvals for CABOMETYX (pNET/epNET) and the potential approval of zanzalintinib in CRC offer new treatment options for difficult-to-treat cancers. The Exelixis Access Services (EASE) program aims to ensure appropriate access and support for patients.
• Collaboration Partners: Ipsen and Takeda continue to commercialize cabozantinib in their respective territories, contributing royalties and collaborating on development. New collaborations (e.g., Merck, Natera) expand the development efforts for pipeline candidates like zanzalintinib.
• Creditors: The company's strong cash position and sustained profitability indicate a healthy financial standing, reducing credit risk.

Next Steps

• Final analysis for STELLAR-303 (CRC, OS in patients without liver metastases) expected in mid-2026.
• PDUFA target action date for zanzalintinib NDA is December 3, 2026.
• Expected top-line results for STELLAR-304 (nccRCC) in mid-2026.
• Anticipated commencement of STELLAR-201 (meningioma) in the first half of 2026.
• Anticipated commencement of STELLAR-316 (CRC) in mid-2026.
• Expects to progress up to two new development candidates into preclinical development during 2026.
• Expects to progress XB773 and a development candidate from SSTR2 agonist program toward potential IND filings in 2026.
• Intends to apply to CMS to maintain the small biotech exception and price floor for cabozantinib products each year through 2030.
• The new EU pharmaceutical legislation is expected to be published, adopted, and enter into force in the first quarter of 2026, with application starting 24 months after entry into force.

Key Dates

Recommendation

Exelixis demonstrated robust financial performance in 2025 with significant revenue and net income growth, primarily driven by strong CABOMETYX sales and new indications. The successful NDA submission for zanzalintinib in CRC, coupled with positive clinical data, signals a strong potential for pipeline diversification and future revenue streams. While patent litigation and regulatory pressures exist, the company's proactive development strategy, strategic collaborations, and substantial cash reserves position it for continued growth and market leadership in oncology. The stock repurchase program also indicates confidence in future value.

Keywords

Oncology, Cabozantinib, CABOMETYX, Zanzalintinib, Cancer Therapy, Biopharmaceutical, SEC Filing, 10-K, Renal Cell Carcinoma, Hepatocellular Carcinoma, Differentiated Thyroid Cancer, Neuroendocrine Tumors, Colorectal Cancer, Drug Development, Clinical Trials, FDA Approval, Ipsen, Takeda, Pipeline, Stock Repurchase, Financial Results, Intellectual Property, Regulatory Affairs