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    ONC
    Earnings call· Dec 2025(Q4 FY25)

    BeOne Medicines Q4 FY25 earnings call ONC

    Feb 26, 2026 Source

    Executive summary

    BeOne Medicines Q4 FY25 — BRUKINSA Dominance and Pipeline Expansion

    BeOne Medicines concluded 2025 with strong financial results, driven by BRUKINSA's continued global leadership and significant revenue growth. The company achieved GAAP profitability and robust free cash flow, while strategically advancing a diverse pipeline across hematology, solid tumors, and emerging immunology assets. Management is focused on deepening its CLL franchise with next-generation therapies and expanding its oncology footprint, supported by a re-engineered R&D engine.

    Highlights

    5

    • Product revenue reached $1.5 billion in Q4, representing 32% year-over-year growth.

    • BRUKINSA global revenues totaled $1.1 billion in Q4, growing 38%, and $3.9 billion for the full year, growing 49%.

    • Full year 2025 free cash flow was over $940 million.

    • Non-GAAP income from operations totaled $1.1 billion in fiscal 2025, up from $45 million in 2024.

    • Five assets achieved clinical Proof of Concept in 2025, and 17 new molecular entities advanced into the clinic over the past two years.

    Concerns

    2

    • Nonrecurring $40 million equity investment impairment in Q4.

    • Income tax expense for 2025 included $25 million of nonrecurring tax expenses and $20 million of timing-related tax expenses.

    Guidance & targets

    17
    CategoryTargetConfidence
    Full-year 2026 revenue
    $6.2 billion to $6.4 billion
    high materiality
    High
    Full-year 2026 GAAP Gross Margin Percentage
    high 80% range
    medium materiality
    High
    Full-year 2026 GAAP Operating Expenses
    $4.7 billion and $4.9 billion
    medium materiality
    High
    Full-year 2026 GAAP Operating Income
    $700 million and $800 million
    high materiality
    High
    Full-year 2026 Non-GAAP Operating Income
    $1.4 billion and $1.5 billion
    high materiality
    High
    Full-year 2026 Other Income and Expenses
    $25 million to $50 million
    medium materiality
    High
    BTK CDAC Accelerated Approval
    potential accelerated approval opportunity
    high materiality
    Medium
    Sonrotoclax (sonro) for relapsed/refractory MCL FDA Approval
    expected in the first half of this year
    high materiality
    High
    Zanu + rituximab in treatment-naive MCL Phase III interim analysis
    expected in the first half of this year
    high materiality
    High
    Multiple Myeloma pivotal Phase III study initiation
    initiate a pivotal Phase III study in combination with CD38 antibody and dexamethasone by the end of this year
    medium materiality
    High
    BGB-43395 Phase III trial initiation in frontline HR-positive breast cancer
    plan to initiate a Phase III trial in frontline hormone receptor-positive breast cancer in the first half of 2026
    high materiality
    High
    B7H4 ADC Phase III study initiation
    A Phase III study is expected to start within 1 year.
    high materiality
    High
    GPC3x41BB bispecific pivotal trial initiation
    A pivotal trial will be initiated before year-end.
    high materiality
    High
    CEA ADC pivotal trials
    planning for the pivotal trials
    medium materiality
    Medium
    ZS vs AV Phase III study initiation in treatment-naive CLL
    just initiated a global Phase III study
    high materiality
    High
    Tislelizumab for HER2-positive gastric cancer filing
    expect to file tislelizumab for HER2-positive gastric cancer in combination with zanidatamab and chemo
    medium materiality
    High
    Immunology PoC readouts
    multiple proof-of-concept readouts this year, including BTK CDAC in CSU and IRAK4 CDAC in RA.
    medium materiality
    High

    Segment performance

    9
    SegmentRevenueYoYQoQMargin
    Global Product Revenue
    Product revenue reached $1.5 billion in the fourth quarter, representing 32% year-over-year growth.
    		$1.5 billion32%——
    BRUKINSA Global
    BRUKINSA global revenues totaled $1.1 billion, growing 38% with strong performance across all geographies. For full year 2025, BRUKINSA global revenues were $3.9 billion, representing growth of 49%.
    Full Year 2025 Revenue: $3.9 billionFull Year 2025 Growth: 49%
    		$1.1 billion38%——
    BRUKINSA U.S.
    In the U.S., BRUKINSA fourth quarter sales were $845 million, driven by volume growth of approximately 30% versus Q4 2024.
    Volume growth: approximately 30% vs Q4 2024
    		$845 million———
    TEVIMBRA
    Meanwhile, TEVIMBRA reported an 18% increase, reflecting continued market leadership in China. This growth was supplemented by contributions from launch markets.
    		—18%——
    In-licensed products
    Our in-licensed products also showed continued strength, growing 9% year-over-year.
    		—9%——
    U.S. Geography
    The U.S. remains our largest market, generating $850 million with year-over-year growth of 38%.
    		$850 million38%——
    China Geography
    China revenue totaled $399 million, an 11% increase compared to the fourth quarter of 2024, supported by TEVIMBRA and BRUKINSA's market leadership and growth from our in-licensed assets.
    		$399 million11%——
    Europe Geography
    Europe contributed $174 million, with 53% year-over-year growth as we continue our launch trajectory with BRUKINSA with increased share across all major markets.
    		$174 million53%——
    Rest of World Geography
    And Rest of World markets grew 74%, driven by market expansion and new launches.
    		—74%——

    Operational metrics

    17
    GAAP Gross Margin
    87%from approximately 84% in the prior year
    FY25

    This year-over-year improvement primarily reflects the benefits from favorable product mix, price and product cost efficiencies.

    GAAP Operating Expenses
    $4.2 billiongrew by 12%
    FY25

    as we are investing with discipline to support our commercial growth and rapidly advance our innovative pipeline.

    GAAP Income from Operations
    $447 million
    FY25

    showcasing the inflection in 2025 to a company that is at scale and profitable.

    Equity Investment Impairment
    $40 million
    Q4 FY25

    other income and expense included a nonrecurring $40 million equity investment impairment in the fourth quarter.

    Income Tax Expense
    $130 millionincreasing from $112 million in 2024
    FY25

    including $25 million of nonrecurring tax expenses and $20 million of timing-related tax expenses in certain geographies. These effects, in part driven by our valuation allowance status, disproportionately impacted the fourth quarter.

    GAAP Net Income
    $287 million
    FY25

    Altogether and including these onetime items, net income reached $287 million in GAAP

    GAAP Diluted EPS
    $2.53
    FY25

    with GAAP diluted earnings per ADS of $2.53.

    Non-GAAP Income from Operations
    $1.1 billionup from $45 million in 2024
    FY25
    Non-GAAP Net Income
    $918 million
    FY25
    Non-GAAP Diluted EPS
    $8.09
    FY25

    which translates to diluted non-GAAP earnings per ADS of $8.09.

    BRUKINSA U.S. Pricing Benefit
    mid-single-digityear-over-year basis
    FY25

    Pricing dynamics in the United States were consistent with commentary provided last quarter with a mid-single-digit pricing benefit on a year-over-year basis.

    New Molecular Entities into Clinic
    17
    Past 2 years

    And over the past 2 years, we have advanced 17 new molecule entities into the clinic.

    Assets achieving clinical PoC
    5
    2025

    In 2025 alone, 5 assets achieved clinical PoC.

    Dose Escalation Cohorts Completed
    around 200
    Past 2 years

    Over the past 2 years, we have completed around 200 dose escalation cohorts across multiple first-in-human studies with a median of just 1.5 months per cohort. The industry norm is roughly 3 months.

    CELESTIAL TN CLL study enrollment
    around 700
    Last year

    last year, we completed enrollment of CELESTIAL TN CLL study with around 700 CL patients across 20 countries and more than 200 sites in just 14 months.

    Sonro NDA filing time
    within 1 monthIndustry standards are typically 4 to 6 months
    Initial filing

    Our most recent NDA filing, sonro's initial filing with the FDA in mantle cell lymphoma was completed within 1 month of top line data. Industry standards are typically 4 to 6 months.

    Sonro China patients medicated
    over 300
    6 weeks since launch

    And since launch, this is about 6 weeks and the reaction in the market has been very positive. We medicated or doctor prescribed for over 300 patients.

    Industry KPIs

    6
    MetricValueDetails
    Capital deploymentover $940 millionUSD
    Product franchise net sales$1.1 billionUSD
    Regulatory approvals filingsApproved
    Therapeutic drug market share50%%
    Prescription volume new startsapproximately 30%%
    Clinical trial efficacy safety data74% PFS, 84% OS%

    Product announcements

    1
    ProductTypeDetails
    Sonrotoclax (sonro)launch

    Risks & headwinds

    4
    Competition from other BTK inhibitors and fixed-duration therapiesOngoing

    Ibrutinib's 6-year PFS and OS of 61% and 77%; acalabrutinib's 6-year PFS and OS of 62% and 76% (non-inferior to ibrutinib); pirtobrutinib's minimal early separation vs ibrutinib (HR 0.845, p=0.4102) with only 18 months follow-up.

    Mitigation: BRUKINSA's superior efficacy and safety profile (HR 0.69, p=0.001 vs ibrutinib, 6-year PFS 74%, OS 84%); development of ZS fixed-duration therapy to address unmet needs in that market segment.

    Limitations of current fixed duration therapiesOngoing

    AMPLIFY trial's AV combination had undetectable MRD of only 34%; AV's PFS at 3 years similar to BRUKINSA's at 6 years; CLL17 trial showed severe infections climbing for 3 years after VO, and a 67% nominally increased risk of death vs ibrutinib for VO; 50% higher chance of progression within 6 years for highest risk patients on VO.

    Mitigation: Development of ZS (zanubrutinib + sonrotoclax) as a potentially best-in-class fixed duration therapy with higher undetectable MRD, higher PFS, favorable safety, and improved convenience.

    CMS Drug Price Negotiation ProgramThis year and next

    Not quantified for BeOne, but noted as a challenge for competitors.

    Mitigation: BRUKINSA's differentiated value proposition and best-in-class clinical results are expected to support its value.

    Uncertainty of tax asset recognition2026

    Potential material tax benefit to income tax provision when recognized.

    Mitigation: Will provide additional updates on income taxes throughout the year.

    Q&A highlights

    9

    How will potential CMS drug price negotiation for competitor products (Ibrutinib, Acalabrutinib) affect BRUKINSA's net pricing longer term?

    John Oyler emphasized BRUKINSA's differentiated value proposition, superior safety, and long-term PFS/OS data, positioning it as a best-in-class product. He stated that while competitors face challenges, BeOne stands by the value BRUKINSA creates for patients.

    “This is, in our mind, a best-in-class product that has demonstrated the translation of its mechanism of action into real clinical results. And I think at this point, certainly, there are challenges for those other products, but we're just standing by the value that the products are creating for patients, and it's there.”

    asked by Michael Schmidt · answered by John Oyler

    2 min read6 chapters

    Detailed Narrative

    01

    BRUKINSA's Market Leadership and Clinical Differentiation

    BRUKINSA has established itself as the #1 BTK inhibitor globally and in the U.S., with its long-term data consistently raising the bar in CLL for efficacy and safety. Head-to-head trials show superior efficacy and a more favorable safety profile, including statistically significant improvement in afib compared to ibrutinib, and superior PFS compared to ibrutinib (hazard ratio 0.69, p=0.001). The company highlights its 6-year progression-free survival and overall survival of 74% and 84% (adjusted for COVID: 77% and 87%).

    02

    CLL Innovation and Fixed Duration Therapy

    BeOne aims to redefine CLL treatment with aspirational goals including life expectancy equal to the general population and time-limited therapies delivering outcomes at least as good as continuous treatment. They argue current ven-based fixed duration options (AV, VI, VO) have limitations in efficacy (e.g., AMPLIFY's AV combination had only 34% undetectable MRD, PFS at 3 years similar to BRUKINSA's at 6 years), safety (e.g., CLL17 showed severe infections climbing for 3 years after VO, and a 67% increased risk of death vs ibrutinib for VO), and convenience.

    03

    ZS (Zanubrutinib + Sonrotoclax) as a Differentiated Fixed Duration Option

    The company believes their combination of zanubrutinib (ZS) and sonrotoclax will be a more efficacious fixed duration regimen without the caveats of current options. Early data for ZS shows the highest undetectable MRD rate and PFS compared to other ven-based fixed duration therapies, with a favorable safety profile (fewer high-grade adverse events, no deaths) and potential for improved convenience (no clinical or laboratory TLS observed, likely only one clinic visit during ramp-up after zanu lead-in).

    04

    R&D Transformation and Pipeline Expansion

    BeOne has transformed its R&D capabilities, moving from isolated wins to repeatable success with a "global clinical development super highway." In 2025, 5 assets achieved clinical Proof of Concept (PoC), and 17 new molecular entities advanced into the clinic over the past two years. The company is expanding beyond CLL into other hematological malignancies (MCL, AML, multiple myeloma) and solid tumors (breast, gynecological, lung, GI cancers) with over 20 assets.

    05

    Emerging Solid Tumor Pipeline

    The re-engineered solid tumor portfolio focuses on critical oncogenic signaling pathways. Key assets include BGB-43395 (CDK4 inhibitor) for HR-positive breast cancer, B7H4 ADC for gynecological cancers and triple-negative breast cancer, GPC3x41BB bispecific for HCC, PRMT5 inhibitor for NSCLC, and CEA ADC. Five programs achieved PoC in 2025, with several pivotal trials planned for initiation in 2026.

    06

    Strategic Entry into Immunology

    BeOne is strategically entering the immunology space, with plans to advance one to two potential cornerstone immunology assets towards registration. This includes a proprietary, off-the-shelf iPSC-derived gamma delta T-cell therapy with 12 genetic engineering modifications, designed to overcome limitations of existing cell therapies. They also anticipate multiple PoC readouts in 2026 for BTK CDAC in CSU and IRAK4 CDAC in RA.

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