By Fineline Cube 
Legend Biotech (NASDAQ: LEGN) published the unaudited financial results for fiscal Quarter 3 2025 (2025Q3) on 12 Nov 2025. The flagship CAR‑T therapy CARVYKTI (ciltacabtagene autoleucel – cilta‑cel) generated net trade sales of ≈ USD 524 million and continues to enroll patients at the newly‑activated Tech Lane facility in Belgium. A US FDA‑ and European Commission (EC)‑approved label update adds overall‑survival data from the Phase 3 CARTITUDE‑4 study, while also incorporating a risk of immune‑effector‑cell‑associated enterocolitis.
Q3 2025 Highlights
- Revenue – Net trade sales of USD 524 million and USD 10.5 million in license revenue (Novartis‑LB2102 & DLL‑3 CAR‑T agreements).
- Treatment Reach – > 9,000 patients treated to date.
- Production – Commercial manufacturing now underway at the Tech Lane plant in Belgium.
- Financial Position – Cash & equivalents: ≈ USD 1.0 billion (as of 30 Sep 2025).
- Operating Result – Net loss of USD 39.7 million in 2025Q3.
Label Updates & New Data
- CARTITUDE‑4 – The pivotal study delivered a statistically significant overall survival (OS) advantage for CARVYKTI over standard pomalidomide‑bortezomib‑dexamethasone (PVd) and daratumumab‑pomalidomide‑dexamethasone (DPd) in relapsed/lenalidomide‑refractory multiple myeloma.
- Regulatory Endorsements – Both the FDA and the European Commission (EC) approved the OS‑based label extension.
- Safety Note – The label now cites the risk of immune‑effector‑cell‑associated enterocolitis based on clinical trial outcomes and post‑marketing observations.
Partnerships & Licensing
| Source | 2025Q3 Revenue | Notes |
|---|---|---|
| Novartis LB2102 DLL‑3 license | USD 10.5 M | One‑time royalty from a separate CAR‑T platform. |
| Janssen collaboration on CARVYKTI sales | – | Collaboration revenue recognised as part of CAR‑T product sales. |
These streams demonstrate the firm’s expanding commercialization footprint beyond the primary CARVYKTI product line.
Investor‑Focused Takeaway
- Scale – Treating > 9,000 patients underlines CARVYKTI’s market penetration and revenue momentum.
- Cash Position – Near‑USD 1 billion cash reserves provide runway for continued R&D and production ramp‑up.
- Profitability Gap – A $39.7 million net loss signals ongoing investment in product development, licensing, and clinical‑streamline operations despite strong sales.
Forward‑looking Statements
The information herein is forward‑looking and subject to risks that may cause actual results to differ materially.-Fineline Info & Tech