Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

Telix Pharmaceuticals Ltd Capital/Financing Update 2020

Jan 28, 2020

31324_rns_2020-01-28_2d73a43e-ef79-4fd2-9f20-77089ae79e45.pdf

Capital/Financing Update

Open in viewer

Opens in your device viewer

Telix Pharmaceuticals Limited ACN 616 620 369 Suite 401, 55 Flemington Road North Melbourne Victoria, 3051 Australia

==> picture [147 x 81] intentionally omitted <==

Prostate Imaging Sales Note to Accompany Appendix 4C

Melbourne (Australia) – 29 January 2020. Telix Pharmaceuticals Limited (ASX: TLX) is pleased to provide a year-end sales update for its prostate cancer imaging product, the TLX591-CDx kit, which is marketed in the United States as illumet[®] (Kit for the preparation of 68Ga-PSMA-11 Injection).

In 2019, Telix delivered approximately 11,530 individual patient doses, prepared from 4,619 TLX591-CDx prostate cancer imaging kits, reflective of growing demand in Europe and continued investigational and clinical trial use in the United States. Telix recorded A$4.41M in orders, comprising A$3.56M cash reported for the full 12 months in the accompanying Appendix 4C, together with A$0.85M in outstanding receivables at 31[st] December 2019. Pricing of the TLX591-CDx kit remained stable across all markets during the period.

Over 80% of patient doses were administered to patients at hospitals in Europe and other exUS countries due to generally more flexible regulations around physician-supervised use of investigational products. The TLX591-CDx kit is designed to be used as a multi-dose kit, however in the United States the kit is typically used to produce a single dose when utilised under a clinical trial.[1]

Telix CEO Dr Chris Behrenbruch stated, “We are delighted to have finished the year with a clear demonstration of global demand for our prostate cancer imaging product. It is significant to note that TLX591-CDx does not currently have a marketing authorisation in any territory. Yet, the investigational, special access and clinical trial use of TLX591-CDx indicates that leading cancer centres value the increased diagnostic accuracy it offers compared to presently available options. We look forward to obtaining the necessary marketing authorisations for TLX591-CDx in the US and Europe during 2020 to make this product available to many more patients in need”.[2]

Telix had A$44.63M cash available at 31[st] December 2019 and deployed A$9.81M during Q4, the majority of which (A$7.48M, 76%) was for R&D and clinical trial activities. Clinical trial expenditure in Q4 was higher than previous quarters due to the activities of the ZIRCON Phase III trial, which are largely non-recurring in nature. Consequently, the statutorily reported ‘estimated quarters of funding available’ is conservative. Telix has previously indicated it estimates it has sufficient funds, excluding any revenue from product sales, to undertake its first two commercial product launches and to continue its operations until mid-2021.[3]

TLX591-CDx ( illumet[®] ) is commercially available as a “cold kit” for the preparation of 68Ga-PSMA-11 for the imaging of metastatic prostate cancer using positron emission tomography (PET). The kit is available for use on a limited basis as an investigational product for an authorised clinical trial (US) on a named patient basis (EU/UK), Special Access Scheme (Australia) or compassionate use (RoW).

TLX591-CDx has not received a marketing authorisation in any jurisdiction.

1 The TLX591-CDx / illumet® kit is designed to be used as a multi-dose kit (up to 50mCi of activity) 2 Subject to requisite regulatory approvals.

3 ASX release 21st November 2019.

Page 1

About Telix Pharmaceuticals Limited

Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telix.com.

Telix Corporate Contact

Telix Investor Relations

Dr Christian Behrenbruch Telix Pharmaceuticals Limited CEO Email: [email protected]

Dr David N. Cade Telix Pharmaceuticals Limited CBO and Head of Investor Relations Email: [email protected]

Important Information

This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “US Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the US Securities Act or an exemption from the registration requirements of the US Securities Act is available. None of the technologies or products described in this document have received a marketing authorisation in any jurisdiction. This announcement has been authorised for release by Dr Christian Behrenbruch, Managing Director and Chief Executive Officer.

Page 2