Forecasting Quarterly Sales Figures, page-57

Illuccix (TLX591-CDx)4 worldwide revenue and customer receipts

A total of $22.5 million in revenue was generated from sales of TLX591-CDx during the quarter. Of this $3.2 million was generated from pre-commercial sales, primarily in Europe and the United Kingdom, reflecting 166% growth on the previous corresponding quarter ($1.2 million, June 2021).

Of the $5.4 million in customer receipts, $3.8 million (USD$2.7 million) was from U.S. commercial sales. Revenue from commercial sales is recognised when a dose is administered. Payment terms average 45 days from invoicing.

Commercial sales of Illuccix in Australia and New Zealand is planned to commence in Q3, 2022.

Illuccix (TLX591-CDx) global regulatory and reimbursement updates

Marketing authorisation applications for TLX591-CDx are under review and progressing in 17 countries (13 European Union Member States, United Kingdom, Canada, Brazil and South Korea). Telix currently has a temporary use (pre-approval) authorisation in the Czech Republic and Brazil.

In summary, the key regulatory updates for the quarter are:

• U.S.: On 17 May Telix filed a supplemental new drug application (sNDA) to the FDA, pursuant to section 505(b)(2) of the of the Federal Food, Drug, and Cosmetic Act (FDCA), for Illuccix. The sNDA relates to an indication expansion for lluccix for patient selection for
  radioligand (PSMA) therapy. The sNDA has been accepted for standard review with a Prescription Drug User Fee Act (PDUFA) user fee goal date of 17 March 2023.
• EU: The Company’s Marketing Authorisation Application (MAA) is being evaluated by the Danish Medicines Agency (DKMA) in its capacity as a Reference Member State, on behalf of the 13 European countries selected by Telix. As previously reported, Telix has until 9 August 20226 to conclude the regulatory review process.
• South Korea: An imported New Drug Application (NDA) has been submitted by Telix’s partner in South Korea, DuChemBio Co, Ltd. (DuChemBio), to the Ministry of Food and Drug Safety (MFDS).
• New Zealand: The drug safety regulator Medsafe has confirmed that Illuccix is an exempt product under the NZ Medicines Act 1981 and Radiation Safety Act 2016. Illuccix may now be supplied and used in New Zealand.

In addition, and subsequent to quarter end, on 1 July 2022, PSMA-PET imaging for prostate cancer was listed on the Medicare Benefits Schedule (MBS) in Australia. This means that MBS funding now covers the initial staging of intermediate to high-risk patients with prostate cancer and the restaging of patients with recurrent prostate cancer, commensurate with the broad clinical indications granted in Australia for Illuccix. Illuccix remains the only Therapeutic Goods Administration (TGA)-approved PET agent for the diagnostic imaging of men with prostate cancer available in Australia.