Business Context and Reporting Period
Company: Legend Biotech Corporation
Filing Type: Form 6-K (Report of Foreign Private Issuer)
Date of Report: October 7, 2025
Subject: Execution of a Component and Product Supply Agreement between Legend Biotech USA Inc. and Janssen Pharmaceuticals, Inc.
Key Financial Metrics
This filing is a qualitative report regarding a contractual agreement and does not contain quantitative financial statements. Consequently, specific values for revenue, profit, cash flow, margins, debt, and liquidity are not provided in this document.
Material Changes and Agreement Details
On October 6, 2025, Legend Biotech USA Inc. and Janssen Pharmaceuticals, Inc. entered into a new Component and Product Supply Agreement. Key terms include:
- Scope: Legend Biotech will manufacture and supply ciltacabtagene autoleucel (cilta-cel) for clinical and commercial use worldwide, excluding Greater China.
- Facility: Manufacturing will occur at the GMP facility in Raritan, New Jersey.
- Supersession: This agreement replaces the Interim Product Supply Agreement dated February 28, 2022.
- Termination: The agreement automatically terminates if the underlying Collaboration Agreement expires or is terminated.
Outlook, Management Commentary, and Risks
Commercial Terms:
- Transfer Pricing: Janssen will pay Legend Biotech a transfer price based on total production costs plus a specified markup.
- Cost Sharing: Ultimately, costs for commercial supply and clinical supply will be shared equally between the parties as "Allowable Expenses" and "Development Costs" under the Collaboration Agreement.
- Raw Materials: Janssen will supply lentivirus, unprocessed cells, and other raw materials to Legend Biotech at cost plus a specified markup.
Conditions Precedent: The agreement becomes effective only after the completion of transition requirements, including the execution of a Product Quality Agreement, Lentivirus and Unprocessed Cells Quality Agreement, Raritan Services Agreement, and receipt of required health authority approvals.
Risks and Contingencies: The agreement includes customary representations and warranties regarding forecasts, ordering, delivery, payments, intellectual property, and indemnification. The full text of the agreement will be filed as an exhibit to the Company's annual report on Form 20-F for the fiscal year ending December 31, 2025.
Investor Verification Checklist
- Verify the execution status of the required Product Quality Agreement, Lentivirus and Unprocessed Cells Quality Agreement, and Raritan Services Agreement to confirm the effective date of the new supply contract.
- Monitor the filing of the full Agreement text in the upcoming Form 20-F for the fiscal year ending December 31, 2025, to review detailed terms not summarized here.
- Assess the impact of the "cost plus markup" pricing model on future gross margins compared to the previous interim agreement.
- Confirm that no health authority approvals are currently pending that could delay the transition to the new agreement.