Legend Biotech (LEGN) Company Report

Legend Biotech announced new long-term clinical data for CARVYKTI® (ciltacabtagene autoleucel), showing a median progression-free survival (mPFS) of 50.4 months in triple-class-exposed relapsed/refractory multiple myeloma patients who had received three prior lines of therapy.
Translational analyses indicated that patients treated earlier with CARVYKTI® exhibited stronger immune fitness and a more immunocompetent tumor microenvironment, which is associated with longer progression-free survival.
In the CARTITUDE-4 study, 80.5% of as-treated patients with standard-risk cytogenetics remained progression-free and off treatment at 30 months after a single infusion of CARVYKTI®.
The company also presented promising first-in-human results for its allogeneic CAR-T candidate, LUCAR-G39D, in B-cell non-Hodgkin lymphoma, demonstrating an overall response rate of 75% and a complete response rate of 37.5%.

2 days ago

6-K

Legend Biotech Reports Strong Q3 2025 Results and Reiterates Profitability Targets

LEGN

Earnings

Guidance Update

Management Change

Legend Biotech reported Q3 2025 total revenues of $272 million, an 84% year-over-year increase, driven by strong CARVYKTI net trade sales of $524 million.
The company achieved an operating loss of $43 million, a 38% reduction from the prior year, and a net loss of $40 million. Adjusted diluted earnings per share was negative $0.05.
Legend Biotech anticipates achieving profitability for CARVYKTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses.
CARVYKTI supply now fully meets demand, with manufacturing network growth including the TechLane facility initiating commercial production, aiming to treat over 10,000 patients annually.
Carlos Santos joined Legend Biotech as the new Chief Financial Officer in August.

Nov 12, 2025, 1:00 PM

Transcript

Legend Biotech Announces Q3 2025 Financial Results and Operational Highlights

LEGN

Earnings

Revenue Acceleration/Inflection

New Projects/Investments

CARVYKTI® Net Trade Sales reached $524 million in Q3 2025, demonstrating an 84% year-over-year growth.
IFRS Total Revenue for Q3 2025 was $272 million, with an IFRS Net Loss of $40 million and an Adjusted Net Loss of $19 million.
As of September 30, 2025, Legend Biotech reported a cash position of approximately $1 billion.
The FDA approved a CARVYKTI® label update to include Overall Survival analysis from the Phase 3 CARTITUDE-4 study, and commercial production was initiated at the Tech Lane facility.

Nov 12, 2025, 1:00 PM

Presentation

Legend Biotech Reports Strong Q3 2025 CARVYKTI Sales and Progress Towards Profitability

LEGN

Earnings

Guidance Update

Revenue Acceleration/Inflection

Legend Biotech reported Q3 2025 CARVYKTI net trade sales of $524 million, marking an 84% increase year over year, with U.S. sales at $396 million and international sales at $128 million.
Total revenues for Q3 2025 were $272 million, driven by 84% year over year collaboration revenue growth, resulting in a net loss of $40 million and an operating loss of $43 million, which represents a 38% reduction from the prior year's operating loss.
The company anticipates CARVYKTI to achieve profitability in 2025 and company-wide profitability in 2026.
Manufacturing capacity for CARVYKTI is now able to fully supply demand, with the TechLane facility initiating commercial production, and the company aims to reach 10,000 annualized doses and eventually 20,000 doses annualized.
The FDA recently approved an update to CARVYKTI's label to include its overall survival benefit based on the phase three CARTITUDE-4 study.

Nov 12, 2025, 1:00 PM

Transcript

Legend Biotech Reports Strong Q3 2025 CARVYKTI Sales and Affirms Profitability Targets

LEGN

Earnings

Revenue Acceleration/Inflection

Guidance Update

CARVYKTI net trade sales reached approximately $524 million in Q3 2025, representing an 84% increase year-over-year and 19% quarter-over-quarter. US net trade sales were $396 million, and ex-US sales were $128 million.
Total revenues for Q3 2025 were $272 million, with a net loss of $40 million and an adjusted diluted earnings per share of negative $0.05. The company holds approximately $1 billion in cash and equivalents.
Legend Biotech anticipates achieving profitability for CARVYKTI by the end of 2025 and company-wide profitability in 2026 (excluding unrealized foreign exchange gains or losses).
The FDA approved an update to include CARVYKTI's overall survival benefit in its label, making it the only approved CAR-T in multiple myeloma with this demonstrated benefit. Manufacturing capacity has been significantly expanded, allowing the company to fully supply demand for CARVYKTI.

Nov 12, 2025, 1:00 PM

Transcript

Legend Biotech Reports Strong Q3 2025 Revenue Growth and Improved Net Loss, Driven by CARVYKTI Sales

LEGN

Earnings

Guidance Update

CFO Change

Legend Biotech reported total revenue of $272.3 million for the third quarter of 2025, a significant increase from $160.2 million in the prior year, primarily driven by $261.8 million in collaboration revenue from CARVYKTI sales.
The company's net loss improved to $(39.7) million for Q3 2025, compared to $(125.3) million in Q3 2024, with an adjusted net loss of $(18.8) million.
CARVYKTI net trade sales reached approximately $524 million, and regulatory updates include U.S. FDA and EC label approvals for overall survival benefit.
As of September 30, 2025, the company maintained a strong liquidity position with approximately $1.0 billion in cash and cash equivalents, and time deposits, and expects CARVYKTI profitability by year-end and company-wide profitability in 2026.
Carlos Santos was appointed Chief Financial Officer.

Nov 12, 2025, 12:00 PM

6-K

Legend Biotech Announces FDA Approval for CARVYKTI Label Update with Overall Survival Data and Safety Warnings

LEGN

Legend Biotech Corporation announced on October 10, 2025, that the U.S. Food and Drug Administration (FDA) approved a label update for its CAR-T cell therapy, CARVYKTI®.
The label update includes overall survival (OS) data from the Phase 3 CARTITUDE-4 study, demonstrating a statistically significant improvement in OS for CARVYKTI in patients with relapsed, refractory multiple myeloma after one to three prior lines of therapy.
The updated label also adds immune effector cell-associated enterocolitis (IEC-EC) to Boxed Warnings and Warnings and Precautions, noting its potential for severe manifestations and fatal outcomes.
Additionally, reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), was added to Warnings and Precautions and Postmarketing Experience, including cases with fatal outcomes.

Oct 14, 2025, 12:00 PM

6-K

Legend Biotech Announces Preliminary CARVYKTI Sales for Q3 2025

LEGN

Earnings

Guidance Update

Legend Biotech Corporation announced preliminary net trade sales for its product CARVYKTI® for the quarter ended September 30, 2025.
CARVYKTI® generated approximately $524 million in net trade sales during this quarter.
The sales figure is based on information provided to Legend Biotech by Janssen and has not been independently verified or audited by Legend Biotech's independent registered public accountants.

Oct 14, 2025, 11:30 AM

6-K

Legend Biotech USA Enters Supply Agreement with Janssen Pharmaceuticals

LEGN

New Projects/Investments

Product Launch

On October 6, 2025, Legend Biotech USA Inc., a wholly-owned subsidiary of Legend Biotech Corporation, entered into a Component and Product Supply Agreement with Janssen Pharmaceuticals, Inc.
Under this agreement, Legend Biotech will manufacture and supply ciltacabtagene autoleucel (cilta-cel) for clinical and commercial use globally, excluding Greater China, from their GMP manufacturing facility in Raritan, New Jersey.
Janssen will pay Legend Biotech a transfer price based on total production costs plus a specified markup, with the costs for commercial and clinical supply ultimately shared equally by both companies as "Allowable Expenses" and "Development Costs" under their existing Collaboration Agreement.
This new agreement supersedes the Interim Product Supply Agreement signed by Legend Biotech and Janssen on February 28, 2022.