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    EXEL
    Earnings call· Jun 2026(Q2 FY26)

    EXELIXIS Q2 FY26 earnings call EXEL

    Aug 5, 2026 Source

    Executive summary

    Exelixis Q2 FY26 — Zanza Pipeline Expansion and Cabo Growth

    Exelixis is executing its strategy to transition from a single-compound company to a multi-franchise oncology business, driven by the expanding zanzalintinib pipeline and continued growth of the cabozantinib franchise. While the company adjusted its full-year revenue outlook due to a more gradual ramp in the NET indication, it remains committed to disciplined capital allocation and advancing its broad clinical development program for zanzalintinib across multiple tumor types.

    Highlights

    5

    • U.S. cabozantinib franchise net product revenues grew approximately 10% year-over-year to $573 million.

    • Global cabozantinib franchise net product revenues grew approximately 13% year-over-year to $806 million.

    • CABOMETYX TRx volume grew 12% in Q2 2026 compared to Q2 2025, outpacing the oral TKI market basket growth of 6%.

    • CABOMETYX achieved second-line plus oral class new patient market share greater than 45% in the NET segment.

    • STELLAR-311 (zanzalintinib in NET) enrollment is months ahead of projections, reflecting strong enthusiasm.

    Concerns

    3

    • Full year 2026 total revenues and net product revenue guidance was lowered and narrowed, with the midpoint reduced by $50 million due to a more gradual ramp for the NET indication.

    • Full year 2026 gross to net deductions estimate was updated to between 30% and 31%.

    • The STELLAR-303 non-liver met subgroup did not achieve statistical overall survival benefit.

    Guidance & targets

    3
    CategoryTargetConfidence
    Full year 2026 Total Revenues and Net Product Revenue
    Lowered and narrowed, midpoint lowered by $50 million
    high materiality
    High
    Full year 2026 Gross to Net Deductions (Cabozantinib franchise)
    Between 30% and 31%
    medium materiality
    High
    Full year 2026 R&D Expense
    Midpoint lowered by $50 million
    medium materiality
    High

    Segment performance

    5
    SegmentRevenueYoYQoQMargin
    U.S. Cabozantinib Franchise
    Strong growth driven by leadership in RCC and NET segments.
    		$573 million10%——
    Global Cabozantinib Franchise
    Includes sales by Exelixis and its partners, Ipsen and Takeda.
    		$806 million13%——
    CABOMETYX (U.S.)
    Clinical trial sales can be choppy between quarters.
    Clinical trial sales: $2.7 million
    		$571 million———
    Neuroendocrine Tumors (NET)
    CABOMETYX is the market leader in this segment, despite a more gradual ramp due to patient kinetics.
    Second-line plus oral class new patient market share: >45%
    		————
    Renal Cell Carcinoma (RCC)
    Growth driven by strong promotional focus on first-line 9ER data and high market share.
    TKI plus IO combination market share: #1Prescribed TKI: #1
    		————

    Operational metrics

    14
    Total revenues
    $629 million
    Q2 FY26

    Includes cabozantinib franchise net product revenues and royalties.

    Royalties earned
    $53 million
    Q2 FY26

    Earned from partners Ipsen and Takeda on their sales of cabozantinib.

    Gross to net deductions
    29.5%lower than Q1 2026
    Q2 FY26

    Reflects the deductions from gross sales to arrive at net product revenues.

    CABOMETYX trade inventory
    2.1 weeks on handflat compared to Q1 2026
    end Q2 FY26

    Inventory levels at the end of the second quarter.

    Total operating expenses
    $380 millionup from $359 million in Q1 2026
    Q2 FY26

    Sequential increase in operating expenses.

    Provision for income taxes
    $50.6 milliondown from $57.2 million in Q1 2026
    Q2 FY26

    Income tax expense for the quarter.

    Non-GAAP net income
    $237 million
    Q2 FY26

    Non-GAAP measure excluding stock-based compensation.

    Cash and marketable securities
    $1.4 billion
    as of June 30, 2026

    Total cash and investments at the end of the quarter.

    Stock repurchases executed
    $312 million
    Q2 FY26

    Completed the October 2025 stock repurchase program during the quarter.

    Remaining stock repurchase authorization
    $598 million
    as of end Q2 FY26

    Remaining amount under the new stock repurchase plan.

    CABOMETYX TRx volume growth
    12%YoY vs Q2 2025
    Q2 2026

    Reflects the strength of CABOMETYX relative to competition in the oral TKI market.

    Colorectal Cancer (CRC) 3L+ patient population
    approximately 23,000
    current

    Represents the target patient population for zanzalintinib in this setting.

    Colorectal Cancer (CRC) 3L+ market opportunity
    $1.5 billion
    annual

    Estimated market size for the third-line plus CRC setting.

    Non-clear cell RCC cases
    approximately 20%
    current

    Highlights the underserved nature of this patient population for STELLAR-304.

    Industry KPIs

    8
    MetricValueDetails
    Pipeline read out calendar—
    Product franchise net sales$806 millionUSD
    Regulatory approvals filingsNDA under review
    Peak long term sales guidance$5 billionUSD
    Therapeutic drug market share47%%
    Prescription volume new starts12%%
    Clinical trial efficacy safety data—
    Collaboration milestone royalty revenue$53 millionUSD

    Risks & headwinds

    4
    Slower ramp for NET indicationFY2026

    Midpoint of FY26 total revenues and net product revenue guidance lowered by $50 million

    Mitigation: Increased new patient market share (>45%), expected increase in refills, expanded GI sales team, refined targeting, and confidence in long-term potential.

    STELLAR-303 non-liver met subgroup did not achieve statistical OS benefitQ2 FY26 data readout

    Non-liver met subgroup did not achieve statistical significance for overall survival

    Mitigation: The ITT population (overall study population) is the primary focus for the NDA, and the treatment effect was similar to interim ITT results.

    Potential for STELLAR-311 (zanza in NET) to cannibalize cabo salesOngoing

    Small impact on commercial patient pool

    Mitigation: Acknowledged as a potential small impact, but the primary driver of slower NET ramp is patient kinetics. Overall market outlook for NET remains positive.

    ANDA 505(b)(2) dynamics and NCCN guideline placementOngoing

    Unquantified risk of a new 505(b)(2) salt gaining NCCN guideline placement without clinical data

    Mitigation: Company is focused on patient safety and prioritizing intellectual property rights, highlighting the lack of clinical data for such products compared to established 505(b)(2) examples.

    What to watch in Q3 FY26

    5

    Zanzalintinib CRC regulatory decision

    early December
    CurrentNDA under review
    TargetPDUFA date in early December

    Why it matters

    This is a critical regulatory milestone for zanzalintinib to become the company's second oncology franchise.

    This continues to be our top priority as we work toward the PDUFA date in early December.

    Q&A highlights

    6

    Can you provide more precise timing for STELLAR-304 data readout and if it might be presented at a major medical meeting this year?

    Management reiterated that top-line results are expected in the second half of 2026, but declined to speculate on exact timing or medical meeting presentations, stating they would message at the appropriate time.

    “As I said in my prior remarks, we are expecting to achieve the planned number of events in the second half of this year. Beyond that, it wouldn't really be appropriate for me to speculate on when exactly that's going to happen or even when the data will be available at a medical meeting.”

    asked by Kyuwon Choi · answered by Dana Aftab

    2 min read6 chapters

    Detailed Narrative

    01

    Zanzalintinib as the Next Franchise Opportunity

    Exelixis is positioning zanzalintinib as its next potential franchise molecule, with a third-line plus CRC filing currently under review and a PDUFA date in early December. The company is accelerating progress on six pivotal trials and plans to initiate a second wave of trials as early as 2027. This strategy aims to build a durable franchise with stacking capabilities, expanding into new GU, GI, and other indications.

    02

    Cabozantinib Franchise Performance and Market Leadership

    The cabozantinib franchise continues to demonstrate strong commercial performance, with U.S. net product revenues growing 10% year-over-year to $573 million and global revenues growing 13% to $806 million in Q2 2026. CABOMETYX remains the leading TKI for RCC, the market leader for oral second-line plus NET, and a key player in liver and thyroid cancers. Its TRx volume grew 12% year-over-year, outpacing the overall oral TKI market basket.

    03

    Neuroendocrine Tumor (NET) Indication Dynamics

    While the NET indication for cabozantinib is experiencing a more gradual ramp than initially projected, due to the indolent nature and unique patient kinetics of this tumor type, the company remains confident in its long-term potential. CABOMETYX has achieved a second-line plus oral new patient market share greater than 45%, and increased refills are expected to drive future demand. The expanded GI sales team and refined targeting are optimizing promotional efforts in this segment.

    04

    STELLAR-303 and CRC Market Opportunity

    The NDA for zanzalintinib plus atezolizumab in third-line plus colorectal cancer, based on STELLAR-303 data, is a top priority with a PDUFA date in early December. This represents a significant commercial opportunity in a large tumor type, with approximately 23,000 patients in the U.S. and an overall market potential of $1.5 billion. Physicians express excitement for a potential immunotherapy-containing regimen for this unmet need.

    05

    Broadening Zanzalintinib's Clinical Development

    Exelixis is actively expanding zanzalintinib's development across multiple indications. This includes STELLAR-316 in resected Stage II/III CRC with molecular residual disease, STELLAR-311 in neuroendocrine tumors (with enrollment ahead of projections), STELLAR-304 in non-clear cell RCC (with top-line results expected H2 2026), and collaborations with Merck on LITESPARK trials in clear cell RCC. Additionally, expansion cohorts in STELLAR-002 are exploring zanza in metastatic bladder cancer and castration-resistant prostate cancer, and STELLAR-201 is evaluating it in recurrent meningioma with strong enrollment.

    06

    Financial Discipline and Capital Allocation

    The company maintains a disciplined approach to expense management and capital allocation, as evidenced by the reduction in R&D expense guidance while keeping projected free cash flow largely unchanged. Exelixis repurchased $312 million of common stock in Q2 2026, completing a prior program and having $598 million remaining under a new $750 million authorization, demonstrating a commitment to returning value to shareholders while investing in the pipeline.

    AI-generated summary of the company’s earnings call. Not investment advice.