Melbourne (Australia) | 7 April 2025
Telix advises that it does not expect any material impact on its business or supply chain as the result of the international trade tariffs levied by the U.S. government, announced on 2 April 2025.
Telix has an extensive U.S.-based manufacturing and distribution infrastructure, including third-party manufacturing sites and radiopharmacy partner networks, for the production and delivery of its FDA[1]-approved products Illuccix® and Gozellix®. The majority of Telix’s workforce is based in the U.S. The Company also notes that pharmaceutical products are currently exempt from the reciprocal tariffs.
Due to the ‘just-in-time’ nature of radiopharmaceutical products, such products are generally manufactured or radiolabelled in close proximity to the point-of-care. This will continue to be the case for new products that the Company expects to launch in 2025.
Telix further notes that it does not rely on rare earth elements of the same kind utilized in semi-conductor supply chains to create its products and is therefore not impacted by the export controls imposed by the Chinese government[2].
The Company also acknowledges reports of significant change at the FDA workforce reassignment, reduction, and restructuring. Despite this, the agency continues to process applications and information requests. Telix has not been notified of any changes to the timelines for its New Drug Application for Pixclara® (TLX101-CDx) or Biologics License Application for Zircaix® (TLX250-CDx)[3].
Read the full ASX release here
TLX101-CDx and TLX250-CDx have not been approved in any jurisdiction.
[1] U.S. Food and Drug Administration.
[2] Announced on 4 April 2025
[3] Brand names subject to final regulatory approval.