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    LEGN
    Earnings call· Dec 2025(Q4 FY25)

    Legend Biotech Q4 FY25 earnings call LEGN

    Mar 10, 2026 Source

    Executive summary

    Legend Biotech Q4 FY25 — CARVYKTI Drives Profitability and Pipeline Expansion

    Legend Biotech concluded FY25 as a leading cell therapy company, driven by the strong commercial performance and expanding global footprint of CARVYKTI. The company achieved CARVYKTI profitability in 2025 and anticipates company-wide profitability in 2026, supported by disciplined expense management and a robust balance sheet. Strategic focus remains on expanding CARVYKTI's use in earlier treatment lines and advancing a next-generation R&D pipeline, including in vivo CAR-T programs.

    Highlights

    5

    • CARVYKTI net trade sales grew 66% year-over-year to $555 million in Q4 FY25.

    • CARVYKTI achieved profitability in 2025, with company-wide profitability anticipated in 2026.

    • Overall revenue reached $306 million in Q4 FY25, representing 64% year-over-year growth.

    • Adjusted net income was positive $2.5 million in Q4 FY25, a significant improvement from a $59 million adjusted net loss a year ago.

    • CARVYKTI manufacturing capacity expanded to support 10,000 annual doses, with a 97% overall manufacturing success rate.

    Concerns

    2

    • Operating loss remained at approximately $20 million in Q4 FY25, despite a 75% improvement year-over-year.

    • R&D expenses declined 3% year-over-year, indicating a shift in investment focus rather than overall growth.

    Guidance & targets

    6
    CategoryTargetConfidence
    Company-wide profitability
    Profitable
    high materiality
    High
    CARVYKTI peak annual sales
    More than $5 billion
    high materiality
    High
    US IND filings
    1 to 2 INDs
    medium materiality
    High
    CARVYKTI top-line growth
    Approximately 50% year-over-year
    high materiality
    High
    CARVYKTI sales growth
    Sequential growth
    medium materiality
    High
    In vivo CAR-T clinical data presentation
    First batch of clinical data
    medium materiality
    Medium

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    CARVYKTI (Total)
    Global net trade sales for CARVYKTI.
    		$555M66%——
    CARVYKTI (U.S.)
    U.S. net trade sales for CARVYKTI, showing continued quarter-over-quarter growth.
    		$420M38%6%—
    CARVYKTI (Ex-U.S.)
    Ex-U.S. sales for CARVYKTI, driven by growth in markets like Germany, Spain, and Belgium, supported by the Tech Lane facility.
    		$135Mover threefold5%—

    Operational metrics

    22
    Revenue
    $306M64% YoY growth
    Q4 FY25

    Total revenue for the fourth quarter.

    Gross margin
    61%
    Q4 FY25

    Company-wide gross margin.

    CARVYKTI net product sales gross margin
    57%
    Q4 FY25

    Gross margin specifically for CARVYKTI net product sales.

    Operating margin
    -6%from -142% in Q2 FY23
    Q4 FY25

    Significant improvement in operating margin over 10 consecutive quarters.

    Total operating expenses growth
    6%YoY
    Q4 FY25

    Growth rate of total operating expenses, significantly outpaced by revenue growth.

    R&D expense change
    -3%YoY
    Q4 FY25

    Decline in R&D expenses as BCMA frontline programs mature and investment shifts to next-gen platform.

    SG&A expense change
    22%YoY
    Q4 FY25

    Increase in SG&A driven by investments in commercial and medical activities for CARVYKTI.

    Operating loss
    -$20Mimproved 75% YoY
    Q4 FY25

    Operating loss for the quarter, showing substantial improvement from the prior year.

    Adjusted net income
    $2.5Mfrom -$59M YoY
    Q4 FY25

    Positive adjusted net income, excluding stock-based compensation and unrealized FX gains/losses.

    Adjusted diluted income per share
    $0.01from -$0.15 YoY
    Q4 FY25

    Adjusted diluted EPS for the quarter.

    Cash, cash equivalents and time deposits
    $949M
    End of FY25

    Total cash position at the end of the fiscal year.

    CARVYKTI patients treated
    More than 10,000
    Cumulative

    Cumulative number of multiple myeloma patients treated with CARVYKTI globally.

    CARVYKTI global treatment sites
    294
    Q4 FY25

    Total number of global treatment sites for CARVYKTI across 14 markets.

    CARVYKTI U.S. authorized treatment centers
    145
    Q4 FY25

    Number of authorized treatment centers in the U.S., with a significant portion being community hospitals.

    CARVYKTI earlier line patient mix
    65%
    Q4 FY25

    Percentage of U.S. CARVYKTI patients treated in earlier lines of therapy.

    BCMA-targeting agent penetration
    <5%
    2025

    Penetration rate of BCMA-targeting agents in the second through fourth line setting for multiple myeloma patients.

    CARVYKTI manufacturing capacity
    10,000
    Annualized

    Installed capacity to support annual production of CARVYKTI doses across all manufacturing nodes.

    CARVYKTI overall manufacturing success rate
    97%
    Q4 FY25

    Overall success rate for CARVYKTI manufacturing.

    CARVYKTI manufacturing success rate (1-3 prior lines)
    99%
    July 2024 - October 2025

    Manufacturing success rate when using cells from patients with 1 to 3 prior lines of therapy.

    CARVYKTI manufacturing success rate (4+ prior lines)
    97%
    July 2024 - October 2025

    Manufacturing success rate when using cells from patients with 4 or more prior lines of therapy.

    In vivo CAR-T development timeline
    6 months
    Candidate selection to first patient dosing

    Rapid advancement of an in vivo CAR-T program from candidate selection to first patient dosing.

    CARVYKTI supply target
    Up to 20,000 doses
    Annualized

    Planned supply capacity with current and ongoing capital expenditures with J&J.

    Industry KPIs

    7
    MetricValueDetails
    Launch access metrics294 global treatment sites; 145 U.S. authorized treatment centerssites/centers
    Pipeline read out calendarCARTITUDE-5 and CARTITUDE-6 enrollment completed; First in vivo CAR-T program data mid-2026
    Product franchise net sales$555MUSD
    Peak long term sales guidanceMore than $5 billionUSD
    Therapeutic drug market share<5%%
    Clinical trial efficacy safety data50.4 months median PFSmonths
    Cumulative patients uptake since launchMore than 10,000patients

    Deals & partnerships

    1
    Johnson & JohnsonCollaboration to scale CARVYKTI to its anticipated potential of more than $5 billion in peak annual sales.

    The partnership focuses on commercialization and capacity expansion for CARVYKTI, including plans to supply up to 20,000 doses annually.

    Risks & headwinds

    3
    Competitive entry of other BCMA-targeting agentsNear-term (PDUFA date December 23 for anito-cel)

    FDA assigned standard review to anito-cel, implying no clinical differentiation over existing therapies.

    Mitigation: CARVYKTI's unmatched efficacy, durability, 10,000+ patient experience, and long-term data (50.4 months median PFS) set a high bar; prepared for any timing of competitor launch.

    Diminished CAR-T efficacy from prior BCMA bispecific use

    Not quantified, but noted as a risk if BCMA bispecifics are used before CAR-T.

    Mitigation: Educating physicians on IMWG guidelines which suggest sequencing is important and that putting a BCMA bispecific in front could diminish CAR-T efficacy.

    Delayed neurotoxicity events (e.g., Parkinsonism) with CARVYKTI

    21 out of 22 Parkinsonism cases in a study of 761 patients occurred in those without response to bridging therapy.

    Mitigation: Implementing effective bridging therapy (e.g., talquetamab) to debulk tumor burden, which has shown to mitigate risk and improve safety/efficacy outcomes; NCCN guidelines updated to include bridging therapy.

    What to watch in Q1 FY26

    5

    CARVYKTI sequential growth

    Next quarter (Q1 FY26)
    Current6% QoQ (US), 5% QoQ (ex-US) in Q4 FY25
    TargetContinued sequential growth across all 4 quarters of 2026

    Why it matters

    Sustained sequential growth is crucial for achieving the FY26 top-line growth target and company-wide profitability.

    we are planning and also we're committed to sequential growth throughout the year that includes all 4 quarters of 2026.

    Q&A highlights

    8

    What are the expectations for CARVYKTI growth in 2026 (US vs. RoW) and what is the business development strategy regarding asset types and stage?

    Management is committed to sequential CARVYKTI growth throughout 2026, targeting approximately 50% top-line growth, aligning with Street consensus. Business development focuses on complementary technologies (e.g., non-lentiviral delivery) and potential partnerships for existing in vivo assets to accelerate global development.

    “we are planning and also we're committed to sequential growth throughout the year that includes all 4 quarters of 2026. And we have said that we feel reasonably confident of delivering CARVYKTI according to the Street consensus number, which is about 50% top line growth from last year, right?”

    asked by Terence Flynn · answered by Ying Huang

    2 min read5 chapters

    Detailed Narrative

    01

    CARVYKTI Commercial Performance & Expansion

    CARVYKTI achieved net trade sales of $555 million in Q4 FY25, a 66% year-over-year increase, driven by continued share gains and site expansion. The product is now available in 14 global markets with 294 treatment sites, including 145 in the U.S. (one-third being community hospitals). The company has installed capacity to support 10,000 annual doses and aims to expand to 20,000 doses with its partner J&J.

    02

    Focus on Earlier Line Treatment

    The majority (65%) of CARVYKTI utilization is now in earlier line settings (second to fourth line), supported by clinical data demonstrating improved survival outcomes and durable responses with earlier intervention. Management emphasizes the unique value proposition of CARVYKTI as a one-time📎 infusion with long-term benefits, especially given the low penetration of BCMA-targeting agents in these earlier lines (<5% in 2025).

    03

    Manufacturing Excellence & Patient Outcomes

    CARVYKTI boasts a 97% overall manufacturing success rate, with 99% for patients with 1-3 prior lines of therapy. New long-term data presented at ASH and Tandem meetings showed a median PFS of 50.4 months for triple class-exposed patients with 3 prior lines of therapy, setting a new standard. Effective bridging therapy is highlighted as crucial for mitigating neurotoxic events and improving safety and efficacy.

    04

    Pipeline Advancement & R&D Strategy

    Beyond CARVYKTI, Legend Biotech is advancing its R&D pipeline, including in vivo CAR-T programs and other blood cancer, solid tumor, and autoimmune programs. The company employs a lean approach leveraging investigator-initiated trials (IITs) in China for rapid clinical proof-of-concept and plans to file 1-2 U.S. INDs by the end of FY26.

    05

    Financial Performance & Profitability Outlook

    The company reported Q4 FY25 revenue of $306 million, a 64% YoY increase, and a gross margin of 61%. Operating margin improved significantly from -142% in Q2 FY23 to -6% in Q4 FY25. CARVYKTI achieved profitability in 2025, and Legend Biotech anticipates company-wide profitability in 2026, supported by a strong cash position of $949 million and disciplined expense management.

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