Activities Report and Appendix 4C for the quarter ended 30 September 2023

Melbourne (Australia) | 18 October 2023

Telix today issues its Appendix 4C quarterly cash flow report and accompanying Activities Report for the quarter ended 30 September 2023 (Q3 2023). All figures are in AUD$ unless otherwise stated 1 and provided on an unaudited basis.

Managing Director and Group CEO, Dr Christian Behrenbruch commented, “The achievement of a fourth consecutive quarter of positive operating cash flow is a major milestone that reflects the Company’s maturation as it delivers on its commercial goals and progresses the development of its industry-leading pipeline.

“We have posted another quarter of double-digit revenue growth for Illuccix in the U.S. with average daily demand for doses continuing to grow month-on-month. Just as importantly we have a number of near-term value drivers on the horizon, being the commencement of the ProstACT GLOBAL study and advancing the U.S. regulatory filing and commercial launch preparations for our renal (kidney) and brain cancer imaging agents. This is reflected in our investment during the quarter in research and development and commercial launch preparation, in line with our stated plans.”

Revenue from U.S. sales of Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) improved 13% to $130.6M (US$85.2M), up from $116.0M in Q2 2023.

Total revenue of $133.6M was generated during the quarter (including commercial sales of Illuccix in the U.S.). Ex-U.S. revenue (including compassionate use availability of Illuccix / TLX591-CDx) 2 was $3.0M. 3

Telix delivered its fourth consecutive quarter of positive net operating cash inflow. The net operating cash inflow for the quarter was $21.4M, a $10.6M improvement on the prior quarter (Q2 2023, net operating cash inflow $10.8M). In line with increased revenue and improved collections, cash receipts from customers improved 16% to $130.7M, up from $112.2M in the prior quarter.

The closing cash balance at 30 September 2023 was $137.4M ($131.7M 30 June 2023). The net operating cash inflow was partially offset by cash outflows from investing activities which included an annual payment of $17.8M for the first instalment of the contingent consideration payable to former Telix Innovations (ANMI) shareholders, based on Illuccix sales.

Increased product manufacturing and related costs reflect higher volume of sales activity and preparation for future product launches. Gross margin is broadly in line with the previous quarter at 63% and reflects stable selling prices and manufacturing costs.

R&D expenditure 4 is in line with plan and reflects the momentum in the key near-term value drivers for the Company being the commencement of the ProstACT GLOBAL study and advancing the U.S. regulatory filings for the TLX250-CDx Biologics License Application (BLA) and TLX101-CDx New Drug Application (NDA).

Telix is progressing new marketing authorisations for Illuccix in a number of jurisdictions, including the United Kingdom (U.K.), European Union (E.U.) 5 and Brazil. As previously reported, these respective applications are currently undergoing assessment and the Company will provide an update on any material changes to status. A Phase III study intended to bridge to the marketing authorisation granted to Illuccix by the United States Food and Drug Administration (FDA) is in progress and recruiting well in China. 6

During the quarter the Company participated in a formal pre-NDA meeting with the Japanese regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) as part of its preparation towards a regulatory filing for Illuccix in Japan. The outcome was clear and helpful feedback to support a regulatory submission of Illuccix in Japan in 2024.

Telix has an industry leading pipeline of late-stage radiopharmaceutical therapeutics and associated diagnostic imaging agents, underpinning its commitment to targeted, precision oncology. The core pipeline is focused on prostate cancer, renal cancer, brain cancer (glioma) and rare diseases (hematologic cancers and bone marrow conditioning). The Company has over 20 clinical studies underway worldwide, including Telix-sponsored and collaborative investigator- initiated trials.

During the quarter, notable updates were published in the news section of the Company’s website (www.telixpharma.com/news-views) and are summarised in this section of the Activities Report.

Telix has multiple clinical studies in its CAIX program, exploring the potential of this target in combination with immunotherapy for the treatment of ccRCC and also its potential across a broad range of cancer indications. CAIX is a protein overexpressed on the surface of ccRCC, the cancer target in Telix’s successful Phase III ZIRCON study. It is also expressed to varying degrees in many other advanced-stage solid tumours with poor prognoses.

The first patients have now been dosed in the STARSTRUCK therapeutic study (ClinicalTrials.gov ID: NCT05868174 ) of TLX250 ( 177 Lu-DOTA-girentuximab) in combination with a Merck KGaA, Darmstadt, Germany DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib (M3814). 7 The open label, single-arm, multi-centre dose escalation and dose expansion study is evaluating safety profile, dosing and activity and will enrol up to 80 patients with CAIX- expressing solid tumours.

The Phase II OPALESCENCE investigator-initiated trial (IIT) of TLX250-CDx in triple-negative breast cancer (ClinicalTrials.gov ID: NCT04758780 ) has completed enrolment with top-line data anticipated shortly.

Dosing of the first cohort of patients has been completed in the Phase I IPAX-2 study of TLX101 (4-L-[ 131 I] iodo- phenylalanine, or 131 I-IPA), running at sites across Australia, New Zealand and Europe. IPAX-2 (ClinicalTrials.gov ID: NCT05450744 ) seeks to confirm the safety profile of TLX101 as a front-line therapy in combination with standard of care (SoC) treatment, ahead of progressing to a label-indicating Phase II/III study in a larger patient population, IPAX-3.

In parallel, building on the success of Telix’s Phase I/II IPAX-1 study (ClinicalTrials.gov ID: NCT03849105 ), 8 TLX101 is being further investigated in the recurrent setting in the Phase II IPAX-Linz IIT, which is progressing well and has now exceeded 70% of the patient enrolment target.

Two studies are being conducted in collaboration with the Company’s strategic partner for the Greater China region, Grand Pharmaceutical Group Limited to demonstrate that the diagnostic utility of TLX591-CDx and TLX250-CDx is equivalent in Chinese and Western populations. The data generated will support future marketing authorisation applications for the Company’s prostate and renal cancer imaging agents in China.

During the quarter, patient dosing commenced in the Phase III registration study of TLX591-CDx (Illuccix) (ClinicalTrials.gov ID: NCT05847348 ) 9 and additional sites were opened.

Telix confirms that payments noted under section 6.1 of the accompanying Appendix 4C include payments of $0.3M to ABX-CRO advanced pharmaceutical services (of which Non-Executive Director Dr Andreas Kluge is Managing Director) for the provision of clinical and analytical services for the Company’s development programs. Payments of $0.3M were made to Directors for Director fees and Managing Director salary.

An investor webcast will be held at 8.30am AEDT on Thursday 19 October (Wednesday 18 October, 5.30pm EDT)

Participants can register for the webcast and find audio call details at the following link: https://edge.media- server.com/mmc/p/b3jsi4g4

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