On November 10, 2026 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, reported its third quarter 2026 unaudited financial results and recent highlights.
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"We made meaningful progress during the third quarter, expanding the reach of CARVYKTI and advancing our pipeline," said Ingrid Zhang, Chief Executive Officer of Legend Biotech. "Five-year CARTITUDE-2 Cohort A data added to the growing body of long-term evidence supporting the curative potential of CARVYKTI, especially in earlier-line multiple myeloma, demonstrating that half of the 20 patients remained alive and progression-free after a single infusion. Together, the promising early line data and updated NCCN guidelines preferring CAR-T ahead of other BCMA-directed therapies well positions CARVYKTI to potentially gain market share in the second- and third-line setting. We also achieved an important milestone for our next generation cell therapy pipeline with the IND clearance for LB2501. We remain focused on disciplined execution, expanding access to CARVYKTI worldwide, advancing our innovative pipeline, and delivering sustained profitability."
Recent Data Highlights
Five-Year CARTITUDE-2 Cohort A Data Demonstrate Durable Outcomes Earlier-Line RRMM
Data from CARTITUDE-2 (NCT04133636) Cohort A, which evaluated patients with relapsed or refractory multiple myeloma (RRMM) after one to three prior lines of therapy (n=20; median follow‑up, 60.7 months), were presented at the 23rd International Myeloma Society (IMS) Annual Meeting in September.
With extended follow-up, patients continued to experience durable clinical benefit, with a median progression-free survival (PFS) of 60.5 months.
Median overall survival was not reached at the time of analysis, and 69.2% of patients were alive at five years.
With a median follow-up of 60.7 months, 10 of 20 patients (50%) remained alive and progression-free without further anti-myeloma treatment ≥5 years after a single CARVYKTI infusion.
The safety profile observed with longer follow-up was consistent with the known safety profile of CARVYKTI, with no new CAR-T-cell-related neurotoxicity reported. Since the previous analysis of CARTITUDE-2 Cohort A with a median follow-up of approximately 30 months[1], one patient developed a new hematologic malignancy (acute myeloid leukemia) and two deaths occurred due to progressive disease and new cancer.
These findings build on five-year CARTITUDE-1 results presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract #7505), in which 32 of 97 patients (33%) with more heavily pretreated RRMM remained progression-free for five years or more after a single infusion with no further myeloma therapy.
Key Business Developments
Compared to the third quarter of 2025, CARVYKTI net trade sales increased 36% in the third quarter of 2026 to approximately $710 million, with U.S. net trade sales growth of 19% and ex-U.S. net trade sales growth of 86%.
CARVYKTI is now available across 373 treatment sites in 20 global markets.
National Comprehensive Cancer Network (NCCN) updated Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Multiple Myeloma. The updated NCCN Guidelines recommend that all patients with multiple myeloma be referred to a T-cell therapy capable center at first relapse for consideration of available therapies. The guidelines also state that when both BCMA CAR-T therapy and T-cell engagers (TCEs) are viable options, current data suggest that CAR-T is preferred, given the established efficacy of TCEs following CAR-T therapy failure, and that prior BCMA-directed therapies should be minimized in patients planning to receive BCMA CAR-T cell therapy.
Received U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) application for LB2501, an investigational, CD19/CD20 dual-targeting in vivo CAR-T therapy for relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma. Early LB2501 clinical data was presented at the European Hematology Association (EHA) (Free EHA Whitepaper) in June 2026 which support the planned Phase I/II trial in the U.S. following the IND clearance. LB2501 is designed to generate CAR-T cells directly within the patient following a single intravenous infusion, making it the first known dual-targeting in vivo CAR-T therapy to receive FDA IND clearance.
Appointed Ingrid Zhang as Chief Executive Officer, effective September 15, 2026. Ingrid Zhang succeeds Alan Bash, who served as Interim Chief Executive Officer beginning in July 2026 and has resumed his role as President, CARVYKTI.
Cash and cash equivalents, and time deposits of approximately $853 million as of September 30, 2026.
Third Quarter 2026 Financial Results
Collaboration Revenue: Collaboration revenue was $353.2 million for the three months ended September 30, 2026, compared to $261.8 million for the three months ended September 30, 2025. The increase of $91.4 million was due to an increase in revenue generated from sales of CARVYKTI in connection with the Janssen collaboration and license agreement (the "Janssen Agreement").
License and Other Revenue: License and other revenue was $6.3 million for the three months ended September 30, 2026, compared to $10.6 million for the three months ended September 30, 2025. The decrease of $4.3 million was primarily attributable to revenue recognized pursuant to our license agreement with Novartis for the development, manufacture, and commercialization of LB2102 and other potential CAR-T therapies selectively targeting DLL-3 (the "Novartis License Agreement"). This revenue is recognized over time in connection with our Phase 1 clinical trial for LB2102.
Cost of Collaboration Revenue: Cost of collaboration revenue was $147.0 million for the three months ended September 30, 2026, compared to $113.2 million for the three months ended September 30, 2025. The increase of $33.8 million was primarily due to Legend Biotech’s share of the cost of sales in connection with CARVYKTI sales under the Janssen Agreement.
Research and Development Expenses: Research and development expenses were $95.3 million for the three months ended September 30, 2026, compared to $113.2 million for the three months ended September 30, 2025. The decrease of $17.9 million was primarily driven by lower expenditures in the cilta-cel clinical program as the patient dosing phases of major trials substantially concluded, partially offset by increased research and development activities primarily related to our in vivo CAR-T programs.
Administrative Expenses: Administrative expenses were $14.8 million for the three months ended September 30, 2026, compared to $34.7 million for the three months ended September 30, 2025. The decrease of $19.9 million was primarily driven by lower share-based compensation expense associated with the forfeiture of certain unvested equity awards and the resulting reversal of previously recognized compensation expense, partially offset by higher professional fees.
Selling and Distribution Expenses: Selling and distribution expenses were $55.0 million for the three months ended September 30, 2026, compared to $52.5 million for the three months ended September 30, 2025. The increase of $2.5 million was primarily due to higher commercial costs, including sales force expansion and Janssen-related marketing and market access activities, which rose with collaboration revenue.
Operating Income (Loss): Operating income for the three months ended September 30, 2026 was $46.8 million compared to an operating loss of $43.3 million for the three months ended September 30, 2025. The year-over-year improvement of $90.1 million was primarily due to higher gross profit from CARVYKTI, as well as lower research and development expenses and lower administrative expenses.
Net Income (Loss): Net income was $51.7 million for the three months ended September 30, 2026, compared to a net loss of $39.6 million for the three months ended September 30, 2025. The year-over-year improvement of $91.3 million was primarily driven by improved operating income.
Adjusted Net Income: Adjusted net income was $55.6 million for the three months ended September 30, 2026, compared to an adjusted net loss of $18.7 million for the three months ended September 30, 2025. The year-over-year improvement of $74.3 million was mainly driven by higher net income, partially offset by a lower share-based compensation adjustment.
Webcast/Conference Call Details:
Legend Biotech will host its quarterly earnings call and webcast today at 8:00am ET. To access the webcast, please visit this weblink.
A replay of the webcast will be available on Legend Biotech’s website at View Source
(Press release, Legend Biotech, NOV 10, 2026, View Source [SID1234674600])