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    ONC
    Earnings call· Mar 2026(Q1 FY26)

    BeOne Medicines Q1 FY26 earnings call ONC

    May 6, 2026 Source

    Executive summary

    BeOne Medicines Q1 FY26 — Strong BRUKINSA Growth & Raised Full-Year Guidance

    BeOne Medicines delivered a strong first quarter, driven by robust product revenue growth, particularly from its foundational BRUKINSA franchise. The company raised its full-year revenue guidance, reflecting confidence in continued global expansion and pipeline advancements. Significant progress was noted across its hematology franchise and solid tumor pipeline, with key clinical milestones and regulatory submissions anticipated.

    Highlights

    5

    • Product revenue reached $1.5 billion, representing 34% year-over-year growth.

    • BRUKINSA global revenues totaled $1.1 billion, with 38% growth across all markets and indications.

    • Full-year 2026 revenue guidance was raised by $100 million, now projected between $6.3 billion and $6.5 billion.

    • Non-GAAP income from operations increased to $414 million in Q1 FY26, up from $139 million in the prior period.

    • Free cash flow generated $161 million in Q1 FY26, an increase of $173 million over the prior period.

    Concerns

    3

    • XGEVA faces enhanced competition due to several biosimilar entrants filing for approval in April.

    • Q1 results included $20 million of nonrecurring gross-to-net favorability for BRUKINSA in the U.S.

    • The IRAK4 program in rheumatoid arthritis was discontinued based on emerging new data.

    Guidance & targets

    15
    CategoryTargetConfidence
    Full-year 2026 revenue
    $6.3 billion to $6.5 billion
    high materiality
    High
    Full-year 2026 GAAP operating expense
    $4.7 billion and $4.9 billion
    medium materiality
    High
    Full-year 2026 GAAP operating income
    $750 million and $850 million
    high materiality
    High
    Full-year 2026 GAAP gross margin
    high 80% range
    medium materiality
    High
    BTK CDAC accelerated approval submission
    potential accelerated approval submission
    high materiality
    High
    TEVIMBRA US approval
    U.S. approval
    high materiality
    High
    Sonro Phase III study initiation
    initiate Phase III study
    medium materiality
    High
    BTK CDAC CSU Phase II study initiation
    initiate Phase II study
    medium materiality
    High
    GPC3/4-1BB bispecific pivotal HCC study
    potentially pivotal study actively enrolling
    high materiality
    High
    CDK4 inhibitor Phase III site activation
    activated its first Phase III site
    high materiality
    High
    New Molecular Entities (NMEs) cadence
    roughly 2 NMEs per year
    medium materiality
    High
    BTK CDAC Phase III enrollment completion
    complete enrollment
    high materiality
    High
    BRUKINSA Mango Phase III interim PFS readout
    interim PFS readout
    high materiality
    High
    ASCO 2026 presentations
    24 abstracts accepted, including 3 oral presentations
    medium materiality
    High
    PMD 5 and CADC data disclosure
    additional data disclosure
    medium materiality
    High

    Segment performance

    10
    SegmentRevenueYoYQoQMargin
    Total Product Revenue
    Strong business momentum across product portfolio.
    		$1.5 billion34%——
    BRUKINSA Global
    Strong growth and performance across all approved markets and indications.
    		$1.1 billion38%——
    BRUKINSA U.S.
    Principally driven by volume growth, with a mid-single-digit pricing benefit year-over-year.
    Volume growth: 28% vs Q1 2025
    		$761 million———
    TEVIMBRA
    Sustained market leadership in China despite competitive environment, with approximately half of growth from outside China.
    		—20%——
    In license and other products
    Continued strength, including robust performance from Amgen in-license portfolio.
    		—27%——
    XGEVA
    Continued to perform very well, but biosimilar entrants filed for approval in April.
    		$90 million———
    U.S. (Geography)
    Remains the largest market.
    		$766 million36%——
    China (Geography)
    Good performance and sustained leadership from TEVIMBRA and BRUKINSA.
    FX impact: 5%
    		$465 million17%——
    Europe (Geography)
    Driving demand growth for BRUKINSA in all major markets, with opportunity to increase brand share.
    FX contribution: 11%
    		$191 million64%——
    Rest of World (Geography)
    Driven by market expansions and new launches in key markets such as Japan and Brazil.
    		—104%——

    Operational metrics

    31
    GAAP Gross Margin
    89%improved from 85% in prior year
    Q1 FY26

    Improved from prior year.

    Operating Expenses
    $1.1 billiongrew by 16%
    Q1 FY26

    Investing to support commercial growth and advance innovative pipeline.

    Income from operations (GAAP)
    $250 millionincrease from $11 million in the prior period
    Q1 FY26

    Significant increase year-over-year.

    Income tax expense
    $32 million
    Q1 FY26

    Primarily reflecting cash tax expenses in certain geographies.

    Net income (GAAP)
    $227 million
    Q1 FY26

    Total net income for the quarter.

    Diluted EPS (GAAP)
    $1.96
    Q1 FY26

    GAAP diluted earnings per ADS.

    Income from operations (non-GAAP)
    $414 millionup from $139 million in the prior period
    Q1 FY26

    Non-GAAP income from operations.

    Net income (non-GAAP)
    $375 million
    Q1 FY26

    Non-GAAP net income for the quarter.

    Diluted EPS (non-GAAP)
    $3.24
    Q1 FY26

    Diluted non-GAAP earnings per ADS.

    BRUKINSA U.S. pricing benefit
    $20 million
    Q1 FY26

    Nonrecurring gross to net favorability.

    BRUKINSA U.S. pricing
    relatively stable
    FY26

    Expected for 2026, consistent with prior commentary, excluding nonrecurring Q1 favorability.

    China revenue FX impact
    5%
    Q1 FY26

    Driven by foreign exchange.

    Europe revenue FX impact
    11%
    Q1 FY26

    Given euro strengthening on a year-over-year basis.

    Sonro potency
    14x more potent
    null

    Than venetoclax.

    Sonro selectivity
    6x more selective
    null

    Than venetoclax.

    GPC3/4-1BB bispecific development timeline
    19 months
    null

    From first-in-human dosing to enrolling first patient in potentially registrational study.

    GPC3/4-1BB bispecific patients enrolled
    over 200 patients
    20 months

    Including over 45 first-line HCC patients treated in combination with Tesla and [indiscernible].

    New Molecular Entities (NMEs) 2011-2020
    11
    2011-2020

    Delivered during this period.

    New Molecular Entities (NMEs) 2021-2023
    10
    2021-2023

    Added during this period.

    New Molecular Entities (NMEs) last 2 years
    18
    last 2 years

    Across small molecules, CDAC, ADC and tristate antibodies.

    BRUKINSA landmark PFS delta vs other continuous BTKi
    12%
    year 6

    Equivalent of 1 in 8 patients not progressing.

    BRUKINSA landmark PFS delta vs fixed duration regimens
    21%
    year 6

    Roughly 1 in 5 patients in the unmutated population.

    BRUKINSA landmark PFS delta vs VO
    27%
    null

    More than 1 in 4 patients who started the study.

    BRUKINSA HR vs ibrutinib (relapsed/refractory)
    0.69
    null

    p-value of 0.001, demonstrating superiority in a head-to-head trial.

    Acalabrutinib HR vs ibrutinib (ELEVATE-RR)
    1
    null

    Crossed over and became numerically worse than ibrutinib at roughly 33 months.

    Pirtob HR vs ibrutinib (BRUIN-314)
    0.845
    null

    p-value of 0.4102, with very short follow-up of only 18 months.

    Pirtob adverse events leading to discontinuation vs ibrutinib
    numerically more
    null

    In BRUIN-314 study, raising tolerability concerns.

    Pirtob average age of patients (BRUIN-313)
    65 years old
    null

    Roughly 5 years younger than respective first-line trials for second-generation covalent BTKis.

    BRUKINSA real-world patient data sets
    over 58,000
    null

    Demonstrate significant real-world benefits.

    BTK CDAC ORR (accelerated approval target)
    50% to 70%
    relapsed/refractory patients

    Target efficacy hurdle for accelerated approval, depending on population and available therapies.

    CDK4 program patients (ASCO data)
    approximately 60 patients
    null

    Frontline for stage IV disease treated in combination with letrozole, data to be presented at ASCO.

    Industry KPIs

    6
    MetricValueDetails
    Capital deployment$161 millionUSD
    Pipeline read out calendar60+abstracts
    Product franchise net sales$1.1 billionUSD
    Regulatory approvals filingsU.S. PDUFA decision soon
    Prescription volume new starts28%%
    Clinical trial efficacy safety data77% PFS, 87% OS%

    Deals & partnerships

    1
    Not namedLicensing option acquisition

    Acquired an exclusive option to license a novel PD-1 VGF CTLA4 trispecific (BB10/TH60), which is expected to enter the clinic in June.

    Risks & headwinds

    3
    Biosimilar competition for XGEVANear-term

    Several biosimilar entrants filed for approval in April.

    Mitigation: Not explicitly stated, but XGEVA continued to perform well in Q1.

    Nonrecurring gross-to-net favorability for BRUKINSA in Q1Q1 FY26

    $20 million

    Mitigation: Company expects relatively stable pricing for the full year, excluding this item.

    Discontinuation of IRAK4 program in rheumatoid arthritisQ1 FY26

    Program discontinued.

    Mitigation: Resources reallocated towards higher-potential opportunities.

    Q&A highlights

    6

    Contextualize BRUKINSA's claim of being the only BTK to show superiority vs. ibrutinib, given Lilly's claims for Pirtob.

    Amit Agarwal clarified that BRUKINSA is indeed the only BTKI to demonstrate superiority to ibrutinib in a head-to-head study (Alpine). He highlighted issues with Pirtob's claims, noting that its 26% risk reduction claim in the relapse setting is based on investigator assessments, not independent review committee (IRC) data, which showed only a 2-event difference. He also stated that Pirtob's treatment-naive subgroup claims are not predefined and lack statistical significance in IRC data, with very short follow-up.

    “BRUKINSA is the only BTKI to demonstrate superiority to ibrutinib in a head-to-head study.”

    asked by Yigal Nochomovitz · answered by Amit Agarwal

    2 min read6 chapters

    Detailed Narrative

    01

    BRUKINSA's Differentiated Profile

    BRUKINSA has firmly established itself as a foundational BTK inhibitor, demonstrating superior efficacy and safety with long-term data in frontline CLL. Its clinical profile shows sustained separation in progression-free survival compared to other BTK inhibitors and fixed duration regimens, with significant deltas observed at the 6-year mark. This robust evidence supports its best-in-class position, particularly against ibrutinib in head-to-head trials.

    02

    Sonro's Transformative Potential

    Sonro, a next-generation BCL-2 inhibitor, is designed to be significantly more potent and selective than venetoclax, with a shorter half-life for a simpler ramp-up. The combination of BRUKINSA and Sonro (ZS) demonstrated a high UMRD rate in the 101 trial, comparing favorably to other regimens. Three Phase III studies are underway for the ZS combination, aiming to change the first-line CLL treatment paradigm and expand BeOne's market presence.

    03

    BTK CDAC Innovation

    The BTK CDAC is a first-in-class therapy for heavily pretreated patients, showing complete BTK degradation and broad mutation coverage. Early study results indicate a high overall response rate. An accelerated approval submission in the U.S. for relapsed/refractory CLL is expected in the second half of 2026, positioning it as a leading innovation in CLL treatment.

    04

    Solid Tumor Pipeline Inflection

    BeOne's solid tumor pipeline is shifting towards late-stage execution, with programs like the CDK4 inhibitor in breast cancer and the GPC3/4-1BB bispecific in hepatocellular carcinoma (HCC) advancing rapidly. The GPC3/4-1BB bispecific demonstrated exceptional development speed, moving from first-in-human dosing to a potentially registrational study in just 19 months, highlighting the company's clinical execution capability.

    05

    Innovation Engine and External Strategy

    The company's in-house technology stack and systematic approach to matching biology with modality have accelerated its innovation engine, consistently delivering new molecular entities. BeOne plans to sustain a cadence of roughly two NMEs per year from 2026. Selective external innovation, such as the acquisition of an exclusive option for a novel PD-1 VGF CTLA4 trispecific, further strengthens the pipeline and creates opportunities for proprietary combinations.

    06

    Immunology Program Updates

    BeOne made a data-driven decision to discontinue the IRAK4 program in rheumatoid arthritis, reallocating resources to higher-potential opportunities. Concurrently, the BTK CDAC CSU Phase II study is on track to initiate by year-end, based on encouraging Phase I data, reflecting a disciplined approach to pipeline management.

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