Telix Pharmaceuticals : Appendix 4C and Activities Report for March 2022 quarter

Telix Pharmaceuticals Limited

ACN 616 620 369

Suite 401, 55 Flemington Road

North Melbourne

Victoria, 3051

Australia

ASX RELEASE

Activities Report and Appendix 4C for March 2022 Quarter

Melbourne (Australia) - 22 April 2022. Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today issues its Appendix 4C quarterly cash flow statement and accompanying Activities Report for the quarter ended 31 March 2022. All figures are in AUD unless otherwise stated.

Financial Summary

• • Telix held cash reserves of $154.7 million on 31 March 2022 ($22.0 million held on 31 December 2021).

• • During the quarter the Company completed a $175.0 million institutional placement.

• • In addition to placement proceeds, cash inflows during the quarter included $1.9 million in receipts from customers (from ex-US pre-commercial sales of Illuccix®), $1.2 million in government tax incentives and $3.5 million from the exercise of options and warrants.

• • Net operating outflows during the quarter were $33.6 million, with total operating outflows of $36.7 million.

• • $20.3 million was invested in R&D, manufacturing and clinical development activities during the quarter, primarily in relation to the Company's therapeutic programs

• • Cash runway per the accompanying Appendix 4C shows 5.1 quarters of operations based on net cash used in operations in the March 2022 quarter. The Company notes this number does not include any anticipated revenue from commercial sales of Illuccix®, which was successfully launched in the United States on 4 April 2022.

Activities Report Overview

The commercial launch in the United States (U.S.) of Telix's lead prostate cancer imaging product, Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection), was a major area of focus during the March 2022 quarter.

Concurrent with releasing and stocking commercial product, Telix undertook significant work to engage customers including on product orientation, implementation of ordering systems, market access and reimbursement education, pre-order and scheduling activities. The result has been a comprehensive customer readiness program that the Company believes will enable Illuccix to successfully launch in what is perceived by the Company to be a high level of anticipation and customer demand.

The first commercial inventory of Illuccix is available through 117 U.S. pharmacies in the Cardinal Health, PharmaLogic and United Pharmacy Partners (UPPI) networks. Further details are provided in the commercial activity update section of this report.1

During the quarter, the Company announced it had completed its target enrolment of 252 patients into the ZIRCON Phase III study of TLX250-CDx (89Zr-DFO-girentuximab), an investigational product for the imaging of clear cell renal cell carcinoma (ccRCC) with positron emission tomography (PET). As permitted under the clinical study protocol, Telix will continue recruiting into the study for up to an additional three months (until approximately June 2022). This additional recruitment will both generate further data in support of the Biologics License Application (BLA) and facilitate continued experience for trial sites ahead of Telix's planned transition to opening a broader, more accessible

1 ASX disclosure 4 April 2022

Expanded Access Program (EAP). Pending final data capture, review and analysis, the Company expects to report the outcome of the ZIRCON study in 2H 2022.

During the quarter, the Company announced the completion of a $175.0 million institutional placement of new, fully paid ordinary shares at an issue price of $7.70 per share. Funds raised are being used to execute on the Company's late-stage clinical studies, advance multiple programs towards commercialisation and build future pipeline and indication expansion.

As part of a long-term capital management strategy, the Company secured a €12.1 million ($18.2 million) financing package for the development of its radiopharmaceutical production facility in Seneffe (Brussels) Belgium. The funding will be applied to building works at the facility which include the build-out of extensive production infrastructure, R&D labs and isotope production capability for both diagnostic and therapeutic applications.

Finally, at the end of March, Telix announced a change of composition of the Board of Directors.2 Mr Oliver Buck, a founding member of the Telix Board, will retire from the Board at the Company's 2022 Annual General Meeting to be held on 18 May, having served since January 2017. Mr Buck is succeeded by Ms Tiffany Olson, an experienced U.S.-based pharma executive, appointed as independent Non-Executive Director.

Dr Christian Behrenbruch, Managing Director and Telix Group CEO stated, "This has been a pivotal quarter for Telix, as we delivered on several major objectives including the Company transformational event of launching of our first commercial product and completion of target enrolment for a Phase III clinical trial. We are strongly encouraged by the level of anticipation and early demand for Illuccix, both in the independent imaging centre and hospital-based segments of the U.S. market, driven by clear inclusion in clinical practice guidelines and, more recently, indicated as a patient selection tool for next-generation prostate cancer therapy. Telix is uniquely positioned to deliver this product on-demand, coast-to-coast across the U.S. With the recent FDA approval of PSMA-targeted radiotherapy3 - and the importance of 68Ga-PSMA-11 for patient selection - it is an exciting time for molecular imaging in Genitourinary, or 'GU' Oncology.

"The recent financing activity - including the $175.0 million placement and $18.2 million project financing package for the buildout of the Company's European manufacturing site will support Telix's growth trajectory as a market leader in the field of radiopharmaceuticals. From a product development and manufacturing perspective, these financial resources enable will enable Telix to advance an important pipeline of products that address major unmet medical need."

Commercial Update

Illuccix (TLX591-CDx) commercial launch underway in the United States and Australia

Illuccix® is now commercially available in the U.S. - initially through 117 commercial nuclear pharmacies in the Cardinal Health, PharmaLogic and UPPI networks.4 Subsequent to the end of the quarter, patients in Indianapolis, New York City, and Seattle were amongst the first to receive doses of Illuccix® following the nationwide release of commercial product in early April.5 The Company was particularly pleased that Indiana University (IU / IU Health) was a "first dose" site as early development collaborations with Dr. Mark Green's lab at IU were fundamental to building the radiopharmaceutical package that subsequently attained FDA approval.

Over 680 imaging sites have been pre-qualified in the lead up to the Company's commercial launch. Telix's distribution network currently covers greater than 85% of eligible PET sites across the United States, in addition to direct hospital customer sales in some territories.

• 2 ASX disclosure 31 March 2022.

• 3 Novartis release 23 March 2022.

• 4 ASX disclosure 4 April 2022.

• 5 Media release 14 April 2022.

The Company's application for a distinct code from the Healthcare Common Procedure Coding System (HCPCS) was filed to meet the January 2022 deadline. Code assignment is anticipated in accordance with the publication schedule set by the Centers for Medicare and Medicaid Services (CMS). Currently, eligible customers can claim reimbursement for Illuccix under the CMS Not Otherwise Classified (NOC) code.

During February, Telix completed and filed an application for pass-through status, which secures a separate payment for a new FDA-approved radiopharmaceutical imaging agent for up to three years (and no less than two years). Pass-through only applies to CMS patients in the Hospital Outpatient Setting. The Company anticipates receipt of its pass-through code effective from 1 July 2022, pending administrative review and acceptance of its submission.

The Company has also formally entered into an interim agreement with the Veterans Affairs Federal Supply Service (FSS). This agreement allows Telix to commence selling Illuccix to any entities that are entitled to FSS pricing. Telix is honoured to serve the Veteran population, an important and vulnerable patient population that is significantly affected by prostate cancer. Of the 9 million Veterans receiving care through the Veterans Health Administration, 500,000 have been diagnosed with prostate cancer - representing an incidence rate that is 40% higher than the general public.6

Preparations for the launch of Illuccix in Australia during Q2 are on track, following the Australian government's decision to reimburse PSMA-PET imaging, effective 1 July 2022.7

Global regulatory approvals

As at the end of the quarter, marketing authorisation applications for TLX591-CDx were under review and progressing in 17 countries (13 European Union Member States, United Kingdom, Canada, New Zealand and Brazil). Telix currently has a temporary use (pre-commercial) authorisation in the Czech Republic and Brazil.

• • 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. During the quarter the Company advised it had been granted an extension to the review period.8 Telix now has until 9 August 2022 to provide responses to questions arising during the final stages of the regulatory review process, and which were received subsequent to the "clock restart" on 9 December 2021.9 The Company expects to conclude its submission to the DKMA before the end of May 2022.

• • New Zealand: During the quarter, Telix's New Medicine Application in New Zealand was accepted for filing by the drug safety regulator Medsafe and has now commenced the abbreviated evaluation process. The abbreviated evaluation pathway allows Medsafe to rely on the regulatory evaluation of an overseas recognised regulatory authority for the purpose of deciding whether to approve a new medicine. Telix is eligible for approval of Illuccix under an abbreviated evaluation based on prior approval from the Australian Therapeutic Goods Administration (TGA) in November 2021.10

• 6 Veterans Prostate Cancer Awareness, Inc. / Veterans Affairs EMR analysis.

• 7 Media release 6 April 2022.

• 8 ASX disclosure 7 February 2022.

• 9 ASX disclosure 10 December 2021.

• 10 ASX disclosure 2 November 2021.

Global distribution agreements

In readiness for an approval decision notification and commercial launch, Telix has continued to build out its distribution network in Europe. During the quarter, Telix entered into the following agreements:

• • UK and Ireland: Xiel Limited, including the concurrent termination of a distribution agreement with Curium Pharma.11

• • Greece and Cyprus: Biokosmos S.A.12

• • Austria, Czech Republic and Slovak Republic: THP Medical Products Vertriebs GmbH (THP), building on a successful collaboration with THP to deliver "magisterial" (compassionate use).

• • Portugal: Sociedade Avanço. 13

Telix now has European commercial distribution agreements in place in France (IRE ELiT), Germany (Eckert & Ziegler Strahlen- und Medizintechnik AG), Italy (Radius R.r.l), Spain (NUCLIBER S.A.), and the UK and Ireland (Xiel Limited) (all EU5 countries), plus Austria, Slovak Republic and Czech Republic (THP), Greece and Cyprus (BIOKOSMOS S.A.), Poland (Synektik Pharma Sp. Zo. o), Portugal (Avanço), Sweden, Denmark, Finland and Norway (all S Ahlén Medical Nordic AB).

Outside of Europe, Telix entered into a commercial distribution agreement during the March quarter with Global Medical Solutions Australia (GMSA) for the Australian market, 14 adding to existing agreements in Brazil (Grupo RPH), China (China Grand Pharma) and South Korea (DuChemBio Co, Ltd.). The Company's commitment to global product delivery significantly differentiates it from competition and places Telix in a leading position to support pharma and medtech collaborations in GU oncology around the globe.

Quarterly sales (Illuccix / TLX591-CDx Kit)

Sales of TLX591-CDx during the March quarter precede commercial launch and are from investigational, clinical trial, magisterial and compassionate use in accordance with local laws and regulations (not as a commercial diagnostic imaging product sold for routine clinical practice).

In the March 2022 quarter, Telix delivered approximately 4,200 individual patient prostate cancer imaging doses, prepared from 1,680 TLX591-CDx prostate cancer imaging kits, representing a 40% increase compared to the corresponding quarter in 2021. Pre-commercial sales recorded during the quarter totalled $1.9 million.

Telix notes that the sales of the TLX591-CDx kit during the quarter is not indicative of reimbursed product volume or pricing in major commercial markets.

Clinical Programs Update

Telix continues to progress its clinical pipeline, with a core focus on prostate cancer, kidney cancer, brain cancer (glioblastoma) and rare diseases (bone marrow conditioning). The Company has 18 clinical trials underway, including collaborative investigator-sponsored studies.

The table, on the following pages, highlights key clinical progress and activity during the quarter, further details can be found in the original ASX or press release disclosures.

• 11 ASX disclosure 29 March 2022.

• 12 Media release 27 January 2022.

• 13 Media release 21 April 2022.

• 14 ASX disclosure 16 February 2022.

Asset	Activity
Prostate Cancer / PSMA
Prostate cancer imaging: TLX591-CDx	Phase I clinical study with Kanazawa University met objectives, demonstrating safety and tolerability as well as the comparability of the pharmacokinetics and dosimetry of 68Ga-PSMA-11 between Japanese and non-Japanese patient populations.15 Results will serve as a basis for advancing the TLX591-CDx program towards regulatory submissions across Asia including in Japan, an important nuclear medicine market.
Prostate cancer imaging: TLX599-CDx NOBLE Registry	Recruitment of patients into the Mexican arm of NOBLE Registry has commenced. The NOBLE (Nobody Left Behind) Registry is collecting clinical data to inform the development of TLX599-CDx (99mTc-iPSMA), an investigational prostate cancer imaging agent that targets PSMA using single photon emission computed tomography (SPECT 16 ). This is a milestone for the Company's relationship with ININ (Instituto Nacional de Investigaciones Nucleares, the Mexcian nuclear agency), which originally developed TLX599-CDx.
Prostate cancer therapy: TLX591 ProstACT study program17	The first patients have been dosed in Telix's PSMA-targeting 'ProstACT' therapeutic program, which is evaluating the efficacy of Telix's lutetium-177 (177Lu)-labelled therapeutic antibodies (TLX591) in all stages of prostate cancer, from first recurrence to advanced metastatic disease.18 The patients, dosed at Princess Alexandra Hospital in Brisbane, Queensland, were treated as part of the ProstACT SELECT clinical trial, a Phase I radiogenomics study running concurrently to the pivotal Phase III study, ProstACT GLOBAL. Subsequent to quarter end, Human Research Ethics Committee (HREC) approval was granted for the Phase II ProstACT TARGET study of TLX591, in patients experiencing a first recurrence of prostate-specific antigen (PSA) after initial therapy for prostate cancer.19
Kidney Cancer / CA9
Clear Cell Renal Cell Carcinoma (ccRCC) imaging: TLX250-CDx ZIRCON Phase III Study	During the quarter, target enrolment of 252 patients was met.20 As permitted under the clinical study protocol, recruitment into the study will continue for up to an additional three months to generate further data in support of the BLA ahead of Telix's plans to open a broader, more accessible EAP. The EAP for TLX250-CDx is currently planned to commence in June 2022.

• 15 Media release 8 February 2022.

• 16 See:www.nobleregistry.org.

• 17 ASX disclosure 19 August 2021.

• 18 ASX disclosure 27 January 2022.

• 19 ASX disclosure 12 April 2022.

• 20 ASX disclosure 8 March 2022.