Legend Biotech (NASDAQ: LEGN) inks global cilta-cel supply deal with Janssen

Rhea-AI Filing Summary

Legend Biotech Corporation, through its wholly owned subsidiary Legend Biotech USA Inc., has entered into a new Component and Product Supply Agreement with Janssen Pharmaceuticals, Inc. covering the manufacture and supply of ciltacabtagene autoleucel (cilta‑cel) for clinical and commercial use worldwide, excluding Greater China. The product will be manufactured at the existing GMP facility in Raritan, New Jersey that both parties already use, and this agreement replaces a prior interim supply arrangement signed in 2022.

The agreement will take effect after agreed transition steps are completed, including several quality and services agreements and any required health authority approvals, and it will end automatically if the broader collaboration and license agreement between the parties expires or is terminated. Janssen will pay Legend a transfer price for the product based on total production costs plus a markup, while the ultimate commercial and clinical supply costs will be shared equally under the existing collaboration framework. Janssen will also provide key raw materials to Legend at its own cost plus a markup, under customary commercial, quality, intellectual property, and indemnification terms.

Insights

Biopharma collaboration and manufacturing analyst

Legend and Janssen formalize long-term cilta-cel supply, aligning cost sharing.

Legend Biotech and Janssen have moved from an interim to a full Component and Product Supply Agreement for ciltacabtagene autoleucel, their partnered cell therapy. Manufacturing remains at the existing GMP facility in Raritan, New Jersey, which suggests operational continuity rather than a change in scale or geography.

The agreement ties product transfer pricing to Legend’s total production costs plus a markup, while ultimate commercial and clinical supply costs are shared equally as "Allowable Expenses" and "Development Costs" under the existing collaboration. This reinforces that both parties remain economically aligned on cilta‑cel, with Janssen also supplying lentivirus, unprocessed cells, and other raw materials on a cost-plus basis.

Effectiveness depends on completing transition requirements, including multiple quality agreements and any required health authority approvals. The contract is also expressly tethered to the broader collaboration and license agreement, automatically terminating if that overarching collaboration ends, which keeps commercial supply and partnership status closely linked over time.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

Date of Report: October 7, 2025

Commission File Number: 001-39307

Legend Biotech Corporation

(Exact Name of Registrant as Specified in its Charter)

2101 Cottontail Lane

Somerset, New Jersey 08873

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F  ☒            Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

Legend Biotech USA Inc. Enters into Component and Product Supply Agreement with Janssen Pharmaceuticals, Inc.

On October 6, 2025 (the “Execution Date”), Legend Biotech USA Inc. (“Legend Biotech”), a wholly-owned subsidiary of Legend Biotech Corporation (the “Company”) and Janssen Pharmaceuticals, Inc. (“Janssen”) entered into a Component and Product Supply Agreement (the “Agreement”), pursuant to which Legend Biotech will manufacture and supply to Janssen ciltacabtagene autoleucel (cilta-cel) (the “Product”) for clinical and commercial use worldwide (excluding Greater China (as defined in that certain Collaboration and License Agreement (the “Collaboration Agreement”), by and among Legend Biotech, Legend Biotech Ireland Limited, Janssen Pharmaceutica NV and Janssen Biotech, Inc., dated December 21, 2017, as amended)) at the GMP manufacturing facility located at Raritan, New Jersey, which Legend Biotech and Janssen currently utilize to manufacture the Product (the “Facility”). The Agreement supersedes the Interim Product Supply Agreement signed by Legend Biotech and Janssen on February 28, 2022.

The Agreement will become effective after the transition requirements as agreed to between Legend Biotech and Janssen, including the full execution of a Product Quality Agreement, Lentivirus and Unprocessed Cells Quality Agreement, and Raritan Services Agreement, and any required health authority approvals, among other items, have been completed. The Agreement will automatically terminate in the event the Collaboration Agreement expires or is terminated.

Under the Agreement, Janssen will pay Legend Biotech a transfer price for the Product based on the total costs necessary for Legend Biotech to produce and supply the Product, plus a specified markup. Ultimately, however, the cost for commercial supply and clinical supply of the Product will be shared equally by Legend Biotech and Janssen as “Allowable Expenses” and “Development Costs,” respectively, under the Collaboration Agreement. Further, Janssen will supply Legend Biotech with lentivirus, unprocessed cells, and certain other raw materials, at a price equal to the total costs necessary for Janssen to produce and/or supply such materials, plus a specified markup.

The Agreement also includes customary representations and warranties and covenants relating to, among other things, forecasts, ordering, delivery and payments, handling and transport, intellectual property, responsibility for non-conforming product, confidentiality and indemnification.

The foregoing description of the terms of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which the Company will file as an exhibit to the Company’s annual report on Form 20-F for the fiscal year ending December 31, 2025.

This Form 6-K shall be deemed to be incorporated by reference in the registration statements of the Company on Form F-3 (Nos. 333-278050, 333-257625, and 333-272222) and Form S-8 (No. 333-239478 and 333-283217), to the extent not superseded by documents or reports subsequently filed.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

		LEGEND BIOTECH CORPORATION
Date: October 7, 2025		By:	/s/ Ying Huang
		Name:	Ying Huang, Ph.D.
		Title:	Chief Executive Officer

FAQ

What did Legend Biotech (LEGN) announce in this Form 6-K?

Legend Biotech reported that its subsidiary, Legend Biotech USA Inc., entered into a Component and Product Supply Agreement with Janssen Pharmaceuticals, Inc. for the manufacture and supply of ciltacabtagene autoleucel (cilta‑cel) for clinical and commercial use worldwide, excluding Greater China.

Which product is covered by Legend Biotechs new supply agreement with Janssen?

The agreement covers ciltacabtagene autoleucel (ciltacel), referred to as the Product, for both clinical and commercial use, manufactured at the GMP facility in Raritan, New Jersey.

How will costs be shared between Legend Biotech and Janssen under the new agreement?

Janssen will pay Legend Biotech a transfer price for ciltacel based on Legends total production costs plus a markup, but the ultimate commercial and clinical supply costs will be shared equally as "Allowable Expenses" and "Development Costs" under their existing Collaboration and License Agreement.

When does the Legend BiotechJanssen supply agreement become effective?

The agreement becomes effective only after specified transition requirements are completed, including full execution of a Product Quality Agreement, a Lentivirus and Unprocessed Cells Quality Agreement, a Raritan Services Agreement, and obtaining any required health authority approvals.

What happens to the supply agreement if the collaboration between Legend Biotech and Janssen ends?

The supply agreement will automatically terminate if the broader Collaboration and License Agreement between Legend Biotech and Janssen expires or is terminated.

What did this new agreement replace for Legend Biotech and Janssen?

The new Component and Product Supply Agreement supersedes the Interim Product Supply Agreement that Legend Biotech and Janssen signed on February 28, 2022.

Will the full text of the Legend BiotechJanssen supply agreement be publicly available?

Legend Biotech plans to file the full text of the agreement as an exhibit to its annual report on Form 20F for the fiscal year ending December 31, 2025.