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Exelixis, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 10 February 2026: press release. Guidance figures: 6 kept. The quarter’s numbers.

Key takeaways

  • Revenue grew on higher cabozantinib volume: Fourth quarter total revenues were $598.7 million and fiscal 2025 total revenues were $2,320.1 million, both above 2024. Net product revenue growth was attributed mainly to higher sales volume. Source
  • Fourth quarter U.S. franchise sales reached $546.6M: CABOMETYX produced $544.7 million of the fourth quarter U.S. franchise total, and COMETRIQ produced $1.8 million. Source
  • FDA accepted colorectal cancer NDA: The FDA accepted the zanzalintinib NDA with atezolizumab for previously treated metastatic CRC. The company is working toward a first potential indication in colorectal cancer. Source
  • Non-liver-metastases endpoint still immature: Overall survival in patients without liver metastases was not yet mature at the data cutoff. A prespecified interim analysis showed a trend favoring the combination. Source
  • STELLAR-304 topline due mid-2026: STELLAR-304 tests zanzalintinib with nivolumab against sunitinib in untreated non-clear cell RCC, with PFS and ORR as primary endpoints. Topline results are expected in mid-2026.
  • Fourth quarter buybacks at $43.17 average: The company bought back $264.5 million of stock in the fourth quarter at an average price of $43.17 per share, completing the $500 million program authorized in February 2025. Source

“The cabozantinib franchise continued to grow with robust demand in renal cell carcinoma and neuroendocrine tumors driving a significant increase in net product revenues in 2025 compared to the prior year.”

Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis

Guidance

AreaPeriodFigureAgainst last quarter
Total revenues Sourcefiscal 2026$2.525 billion - $2.625 billionKept
Net product revenues Sourcefiscal 2026$2.325 billion - $2.425 billionKept
Cost of goods sold, % of net product revenues Sourcefiscal 20263.5% - 4.5%Kept
Research and development expenses Sourcefiscal 2026$875 million - $925 millionKept
Selling, general and administrative expenses Sourcefiscal 2026$575 million - $625 millionKept
Effective tax rate Sourcefiscal 202621% - 23%Kept

What changed from last quarter

  • Guidance kept: Management said it is maintaining the fiscal 2026 financial guidance it gave in January 2026. The ranges match those in the January release. Source
  • New: The FDA accepted the zanzalintinib NDA for previously treated metastatic CRC with atezolizumab, announced in February 2026. Source

Results and growth drivers

  • Revenue grew on higher cabozantinib volume: Fourth quarter total revenues were $598.7 million and fiscal 2025 total revenues were $2,320.1 million, both above 2024. Net product revenue growth was attributed mainly to higher sales volume. Source
  • Full-year collaboration revenue declined: Collaboration revenues were $197.3 million in 2025 against $359.3 million in 2024. Management attributed the drop to lower milestone revenue and development reimbursements, partly offset by higher Ipsen royalties. Source
  • Fourth quarter earnings per share: GAAP net income was $244.5 million, or $0.88 per diluted share, in the fourth quarter; non-GAAP diluted EPS was $0.94. Fiscal 2025 GAAP diluted EPS was $2.78. Source

Cabozantinib franchise performance

  • Fourth quarter U.S. franchise sales reached $546.6M: CABOMETYX produced $544.7 million of the fourth quarter U.S. franchise total, and COMETRIQ produced $1.8 million. Source
  • Global franchise sales reached $2.9 billion: Exelixis and partners Ipsen and Takeda generated $2.9 billion of global cabozantinib net product revenues in 2025. Source
  • New NET indications approved in March 2025: The FDA approved CABOMETYX for pancreatic and extra-pancreatic NET. A CABINET subgroup presented at ESMO 2025 showed reduced risk of progression or death in lung or thymic NET. Source
  • Market leader position in renal cell carcinoma: As of Q3 2025 CABOMETYX was the market leader in RCC, the number one TKI monotherapy and the most prescribed TKI with immunotherapy.

“is working diligently to advance a first potential indication in metastatic colorectal cancer, following the recent acceptance of our New Drug Application by U.S. regulatory authorities.”

Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis

Zanzalintinib regulatory and pivotal progress

  • FDA accepted colorectal cancer NDA: The FDA accepted the zanzalintinib NDA with atezolizumab for previously treated metastatic CRC. The company is working toward a first potential indication in colorectal cancer. Source
  • STELLAR-303 survival benefit across subgroups: STELLAR-303 met one dual primary endpoint, overall survival in the ITT population. The survival benefit held across pre-specified subgroups, including geography and liver involvement. Source
  • Non-liver-metastases endpoint still immature: Overall survival in patients without liver metastases was not yet mature at the data cutoff. A prespecified interim analysis showed a trend favoring the combination. Source
  • STELLAR-304 topline due mid-2026: STELLAR-304 tests zanzalintinib with nivolumab against sunitinib in untreated non-clear cell RCC, with PFS and ORR as primary endpoints. Topline results are expected in mid-2026.
  • STELLAR-311 enrolling in advanced NET: STELLAR-311 is a phase 2/3 pivotal trial of zanzalintinib versus everolimus as a first oral therapy in advanced NET, with PFS as the primary endpoint.

Partner and collaboration activity

  • Merck began LITESPARK-033 trial: Merck started LITESPARK-033 in December 2025, testing zanzalintinib with belzutifan against cabozantinib in first-line advanced RCC under the companies' clinical collaboration. Source
  • Natera assay to identify MRD-positive patients: Natera will supply its Signatera assay to identify MRD-positive patients for STELLAR-316, the Exelixis-sponsored phase 3 trial in resected stage II/III CRC. Source
  • Partner royalties on cabozantinib sales: Royalties on partner cabozantinib net product revenues were $52.8 million in the fourth quarter and $179.2 million for 2025. Source

“2026 is shaping up to be a milestone-rich year for Exelixis.”

Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis

Costs, margins and pricing

  • U.S. list price increase built into 2026: The 2026 net product revenue guidance includes a 3.0% increase in U.S. wholesale acquisition cost for CABOMETYX and COMETRIQ from January 1, 2026. Source
  • Research and development expense declined: R&D expense was $213.2 million in the fourth quarter and $825.0 million for 2025, against $249.0 million and $910.4 million in 2024. Source
  • Full-year SG&A increased on marketing: SG&A was $123.0 million in the fourth quarter, down from $134.3 million. Full-year SG&A was $518.7 million, up from $492.1 million, on marketing, stock compensation and personnel. Source
  • Income tax provision for quarter and year: The provision for income taxes was $8.2 million in the fourth quarter and $158.6 million for the year, against $44.9 million and $160.4 million in 2024. Source

Capital, buybacks and cash

  • Fourth quarter buybacks at $43.17 average: The company bought back $264.5 million of stock in the fourth quarter at an average price of $43.17 per share, completing the $500 million program authorized in February 2025. Source
  • Cumulative buybacks since March 2023: Since the first program in March 2023, the company has retired 76.7 million shares for $2.16 billion, at an average of $28.14 per share, through fiscal 2025 year-end. Source
  • Up to $750M authorized through 2026: The board authorized up to an additional $750 million of buybacks before December 31, 2026. Repurchases under this program began in the fourth quarter. Source
  • January year-end cash estimate: The January release estimated year-end cash, cash equivalents and marketable securities at about $1.65 billion, on a preliminary basis. The February release does not state a year-end cash figure.

Pipeline and early-stage programs

  • XL557 somatostatin agonist nearing IND: XL557 is an oral small molecule somatostatin receptor 2 agonist for NET. A potential IND filing for it is planned for 2026.
  • XB773 DLL3 antibody-drug conjugate: XB773 pairs an exatecan payload with an antibody against DLL3, a protein expressed in neuroendocrine carcinomas. A potential IND filing is planned for 2026.
  • Four phase 1 programs ongoing: Four phase 1 programs are ongoing. The company plans to move molecules into full development only if the phase 1 data are supportive.
  • STELLAR-201 meningioma trial planned: The planned STELLAR-201 trial tests zanzalintinib in recurrent meningioma, where the company describes no approved systemic therapies.

Strategy and commercial build-out

  • GI sales team buildout expedited: Management expedited the full buildout of the GI sales team to accelerate cabozantinib growth and prepare for future zanzalintinib indications. Source
  • Top-5 solid tumor oncology goal: Management's stated goal is to become a top-5 solid tumor oncology company through a multi-franchise approach that manages risk.
  • December R&D Day set strategy: The December 2025 R&D Day covered the R&D strategy, the multi-franchise approach, zanzalintinib progress and the early-stage pipeline. Source

Coming up, as management said on 10 February 2026

  • STELLAR-303 non-liver-metastases final analysis: Final analysis of the overall survival endpoint in patients without liver metastases is expected in mid-2026, based on current event rates. Source
  • STELLAR-304 topline results: Topline results from STELLAR-304 are anticipated in mid-2026, based on current event rates. Source
  • STELLAR-316 and STELLAR-201 start mid-2026: Planned starts for STELLAR-316 and STELLAR-201 are set for mid-2026. STELLAR-201 is a potential label-enabling trial in recurrent meningioma. Source
  • Zanzalintinib CRC action date December 3, 2026: The FDA set a standard review for the zanzalintinib NDA, with a PDUFA target action date of December 3, 2026. Source
  • Zanzalintinib revenue excluded from guidance: Guidance excludes any zanzalintinib revenue from a potential U.S. approval and launch in previously treated CRC. Source
  • Two IND applications planned in 2026: The company expects to file two Investigational New Drug applications in 2026: one for XB773 and one for a somatostatin receptor 2 agonist candidate. Source
  • Second Merck trial details pending: Merck will make details of the second Merck-sponsored zanzalintinib and belzutifan RCC trial available at a later date. Source

Figures management reported

FigureReported
CABOMETYX U.S. net product revenues, fiscal 2025 Source$2,113.4 million
COMETRIQ U.S. net product revenues, fiscal 2025 Source$9.4 million
Cabozantinib franchise U.S. net product revenues, Q4 2025 Source$546.6 million
Global cabozantinib franchise net product revenues, 2025 Source$2.9 billion
Royalty revenues, Q4 2025 and fiscal 2025 Source$52.8 million and $179.2 million
Research and development expenses, fiscal 2025 Source$825.0 million
STELLAR-303 pivotal trial result SourceMet one dual primary endpoint
FDA PDUFA target action date, zanzalintinib in CRC SourceDecember 3, 2026
FDA approval, CABOMETYX pNET and epNET SourceMarch 2025
STELLAR-304 topline results timingMid-2026

Risks management discussed

  • Operational: The non-liver-metastases endpoint data were not yet mature at the data cutoff, so the timing of its result depends on event rates. Source
  • Financial: The company stated that the repurchase program may be changed or stopped at any time, and that it does not commit to buy any amount of stock. Source
  • External: Timing and details of the second Merck-sponsored zanzalintinib and belzutifan trial rest with Merck. Source

Earlier plans management reported on

  • Met: Management said it had announced in June that STELLAR-303 met one dual primary endpoint, overall survival in the ITT population. Source
  • Not stated: Management said it is maintaining the financial guidance provided earlier for fiscal 2026. Source
  • Not stated: The company said the trial will proceed to the planned final analysis for the non-liver-metastases endpoint, expected in mid-2026. Source
  • Not stated: Management said it had expedited the full buildout of the GI sales team, a step it first described in the earlier release. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.