Telix Pharmaceuticals (TLX) Investor Update summary

FDA Review and Issue Identification

• FDA issued a Refusal to File notice for the TLX250-CDx BLA due to a sterility assurance issue related to filter validation in the manufacturing process, specifically involving a 0.22-micron filter in the automated dispensing process.

• The issue is limited to the Chemistry, Manufacturing, and Controls (CMC) section, with no concerns raised regarding clinical or non-clinical data or safety and efficacy.

• All Process Performance Qualification batches passed sterility requirements.

Remediation Plan and Timeline

• Remediation involves conducting a standard bacterial retention study and documenting the process, expected to be completed within 90 days.

• The company anticipates a delay of about one quarter for resubmission and approval, with efforts to accelerate the process where possible.

• A formal meeting with the FDA will be held to ensure the remediation plan is agreed upon in advance, and the resubmission will update only the relevant CMC module, but the entire BLA will be resubmitted.

• A full U.S. commercial launch is still targeted for 2025.

Financial and Operational Impact

• The delay is considered non-material, with no impact on 2024 revenue forecasts or R&D expenditure; revenue guidance for FY24 remains at US$490M–US$510M.

• Consensus 2025 revenues are not materially affected as unapproved products are not included in guidance.