Activities Report and Appendix 4C for December 2021 Quarter
Melbourne (Australia) – 24 January 2022. Telix provides its Appendix 4C quarterly cash flow statement and accompanying Activities Report for the quarter ended 31 December 2021.
Telix is pleased to provide its Appendix 4C quarterly cash flow statement and accompanying Activities Report for the quarter ended 31 December 2021.
The December quarter culminated in the receipt of regulatory approval from the U.S. Food and Drug Administration (FDA) for Telix’s lead prostate cancer imaging product, Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection). This followed receipt of regulatory approval from the Australian Therapeutic Goods Administration (TGA) in November.
Alongside ongoing clinical development activity across the Company’s broad research pipeline and management of the final stages of the United States New Drug Application (NDA) process for Illuccix, preparations towards commercial launch in Australia and the United States remained a key area of focus in the December quarter. These preparations aim to ensure the seamless transition to commercial rollout from Q1 2022.
Dr. Christian Behrenbruch, Managing Director and Telix Group CEO said “To achieve our first regulatory approval– in both the United States and Australia – is a major achievement and marks our transition to a commercial-stage company. In the initial stages of launch we will focus on our existing users and possible early adopters to build a foundational customer base, as well as executing a wide-reaching market access and education campaign to nurture new customer sites and create demand, ahead of securing reimbursement status for Illuccix in the United States.
“The validation of our first regulatory approvals, the depth and quality of our clinical pipeline and our strength in supply chain and manufacturing uniquely positions Telix as a vertically-integrated leader in the global radiopharmaceutical industry. We look forward to progressing on all fronts in 2022 and further unlocking the value inherent in our pipeline.”
To view the full Appendix 4C and Activities Report please click here.
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