Prostate CancerImaging*

US Commercial Update

October, 2018

IllumetTM

*68Ga-PSMA-11 is an investigational product in the United States andhas not received marketing authorization from the US Food and Drug Administration (FDA)

Overview

• Telix’s prostate cancer imaging product - illumet - is commerciallyavailable in the USA. First revenues and a major milestone for Telix

• illumet is a “cold kit” for the preparation of 68Ga-PSMA injectable* for theimaging of prostate cancer with Positron Emission Tomography (PET)

• The illumet product was developed by ANMI SA and commercialized forthe US market by Telix Pharmaceuticals (US) Inc. – a wholly-ownedsubsidiary of Telix Pharmaceuticals Limited (ASX: TLX)

• Telix (USA) has entered into a sales and distribution agreement for theillumet kit with Cardinal Health

• Cardinal Health’s Nuclear Pharmacy Services business is the largestradiopharmacy network in the USA and a strong channel for illumet

• The Cardinal Health agreement in conjunction with several commercialcollaborations (UPPI) and ongoing clinical trials (MSKCC, Endocyte)positions illumet as a serious contender in the USD $500m prostatecancer imaging market in the United States

2*68Ga-PSMA-11 is an investigational product in the United States andhas not received marketing authorization from the US Food and Drug Administration (FDA)

IllumetTM

3

Local DiseaseLocally

AdvancedLymph Node

MetsDistant Mets

Low Risk Medium Risk High Risk

Active Surveillance

Radical Prostatectomy

Radical Prostatectomy

Radical Prostatectomy

EBRTEBRT +

Endocrine Tx

EBRTEBRT + LDR

BrachytherapyEBRT + HDR + Endocrine Tx

LDR Brachytherapy

EBRT + Endocrine Tx Watchful

Waiting

Radical P’tectomy ++

P’tectomy + Endocrine Tx

Endocrine Tx

EBRT + Endocrine Tx

EBRT + Endocrine Tx

Bone Seeking Agents

EBRT + HDR + Endocrine Tx

Endocrine TxSymptom

Oriented Tx

Watchful Waiting

Active Surveillance

Watchful Waiting

Watchful Waiting

Watchful Waiting

Why is imaging so important to prostate cancer management?

A lot of watching and waiting…

EBRT = External Beam Radiation Therapy

This treatment matrix illustrates “typical” strategies for

treating prostate cancer (darker blues illustrate a trend

toward systemic therapy).

The US market is vast

• Prostate cancer (PCa) is the most common male cancer in the US1. 160,000 new cases diagnosed annually in men over 50. Three million men are living with prostate cancer2

• Imaging will play a role all the way from staging high-risk patients, through recurrence to monitoring disease in response to therapy

• Localizing metastatic disease early gives more treatment options but existing imaging solutions are inadequate

• A patient who progresses post-prostatectomy will have at least 3 imaging studies over the course of their treatment journey

• Reimbursement benchmarks for PCa imaging agents are in excess of USD $3,000 / dose (i.e. Axumin® / Blue Earth Diagnostics)

• PCa imaging is at a USD $500m realizable market opportunity, dominated by imaging Prostate-Specific Membrane Antigen or “PSMA” with Positron Emission Tomography (PET)3

1) Excluding skin cancer

2) Source : American Cancer Society

3) Jadvar et al. J Nucl Med February 1, 2018 vol. 59 no. 2 228-229

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What is PSMA?

• PSMA stands for Prostate-Specific Membrane Antigen

• PSMA is a cell surface protein that is ubiquitously expressed by prostate cancer cells, including metastases

• PSMA has some normal tissue expression (gastric, kidney, exocrine glands – including salivary and lacrimal glands)

• PSMA is “over expressed” (thousands of times higher expression) in prostate cancer / mets, which means that the imaging of PSMA expression produces very high-contrast images of tumour extent

• There are a number of small molecules that have been developed in academia that target PSMA for imaging – Telix (through its partnership with ANMI) is developing PSMA-11, the most widely used targeting agent with clinical experience in thousands of patients

Prostate

Specific

Membrane

Antigen

5

PSMA imaging with PET is highly sensitive

D) A typical PSMA-11 projection image

illustrating the biodistribution of the tracer2

tumour load Low Medium High

PSA 4.8ng/ml 454ng/ml 2860ng/ml

Salivary and

lacrimal gland

uptake is

normal

Slight liver

uptake

High

kidney

uptake

Bladder

(excreted

tracer/urine)

Cancer

EVERYWHERE

It is possible to image disease with

PSMA, even at very low PSA levels

(= low tumour burden)

The three panels A)-C) illustrate

how PSMA imaging avidity

changes as a function of PSA

levels (from low to high PSA). All of

these patients are imaged post-

prostatectomy1

A few highly vivid tumours are

marked for noting (red arrows)

A B C

D

1) Adapted from : Oncotarget. 2017; 8:55094-55103

2) Image from : J Nucl Med January 1, 2017 vol. 58 no. 1 81-84, teaching resource

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There are two ways to produce PET radiopharmaceuticals for PCa

Cyclotrons. 18F is the most commercially used

isotope (2 hour half-life). Very high-scale

production but also high infrastructure /

operating cost, ageing install base. Scheduled

production means less patient flexibility and

challenging to deliver product to the “last mile”

Generators. For PET imaging we use 68Ge/68Ga

(gallium) generators. This is a portable radiation

source that “lives” in the hospital radiopharmacy

and is replenished every 6 months or so.

Convenient, dose-on-demand, easy to use. Lower

throughput but can be used anywhere. 68Ga has a

short half-life of 68 minutes which means that a

dose needs to be prepared very quickly

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Our solution : illumet

• Initially focused on the generator-based approach using 68Ga

• illumet is a packaged “cold kit” for the rapid preparation of 68Ga-PSMA-11*

• Enables PET imaging doses to be prepared on-demand, anywhere

• Proprietary chemistry (via our technology partner, ANMI) enables rapid preparation of a patient-ready dose in under 5 minutes

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Fast. Cost-Effective. Convenient. Everywhere

IllumetTM

TM

*68Ga-PSMA-11 is an investigational product in the United States andhas not received marketing authorization from the US Food and Drug Administration (FDA)

illumet : a true “shake and shoot” product

A package containing all the components

necessary to attach the radioactivity to a targeting

agent (PSMA-11). The kit is used at room

temperature (no heating) and takes a few minutes

to prepare an injection-ready dose*.

Up to 4 hours

stability

68Ga Generator The “Kit” 68Ga–PSMA11

9

TM

*68Ga-PSMA-11 is an investigational product in the United States andhas not received marketing authorization from the US Food and Drug Administration (FDA)

Extensive validation

• We have validated illumet with the three leading brands of 68Ga (gallium) generators used in the United States

• Validation data with IRE, E&Z and ITG generators was provided to the FDA in our Drug Master File (DMF) submission for the product*

• Currently validated generators reflect >95% of the install base of 68Ga generators in the United States

• Telix is continuing to validate with other 3rd party generators that are starting to become available in the US (i.e. iThemba)

• Since 68Ga can also be produced via cyclotron, we are also validating the illumet with 68Ga produced from GE and IBA cyclotrons

• We will amend our FDA DMF to include support for cyclotron-produced gallium by end-2018

10*68Ga-PSMA-11 is an investigational product in the United States andhas not received marketing authorization from the US Food and Drug Administration (FDA)

illumet PSMA imaging kit – FDA status

• DMF type II has been filed and successfully reviewed by the FDA (DMF #032631)

➢ Kit for the preparation of 68Ga-PSMA-11 Injection*

• 2 active INDs have referenced our DMF, others in progress

➢ MSKCC expanded access Phase II study (500 patients)

➢ Endocyte VISION Phase III study (750 patients)

• By year-end the illumet kit will be “made in the USA” at 20,000 unit scale at an FDA-inspected facility

• New Drug Application (NDA) strategy for 68Ga-PSMA-11 in progress, with early input from the US Society of Nuclear Medicine and Molecular Imaging (SNMMI)

11

TM

*68Ga-PSMA-11 is an investigational product in the United States andhas not received marketing authorization from the US Food and Drug Administration (FDA)

illumet commercial partners – US market

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Cardinal Health (NYSE:CAH)

• Signed a distribution and pharmacy services agreement

• Cardinal Health has the largest US nuclear pharmacy network with extensive experience with 68Ga-based PET radiopharmaceuticals

• Cardinal Health may use the kit to compound doses of 68Ga-PSMA aswell as distribute the illumet kit directly to qualified customers*

• An ideal partner for Telix in the US

United Pharmacy Partners (UPPI)

• Initial collaboration agreement with UPPI to validate the use of theillumet kit with a UPPI-sourced 68Ga generator solution

• UPPI has an extensive nuclear pharmacy network in the US withthe potential to deliver significant patient volume in the future

TM

*68Ga-PSMA-11 is an investigational product in the United States andhas not received marketing authorization from the US Food and Drug Administration (FDA)

Competition

Our competition mostly relies on 18F cyclotron-based manufacturing, which is expensive, complex and relies on aging infrastructure

• Blue Earth Diagnostics (Private, GE spin-out)

➢ Axumin®, approved by FDA in 2016. 18F-basedtracer. Inferior to PSMA. Did $100m in revenue last year

• AAA (NASDAQ: AAAP, acquired by Novartis)

➢ License agreement with CTT to develop and marketCTT1057 - 18F-based PSMA tracer. Early stage (Ph I) also some activity around 68Ga-PSMA-R2 (Phase I/II)

• Progenics (NASDAQ: PGNQ)

➢ PyL™, 18F-based PSMA imaging agent for prostate cancer developed at Johns Hopkins. Phase III, but delayed

• Theragnostics (Private)

➢ Reported to have a kit for 68Ga. Limited evidence of progress

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Going commercial

• We have started selling

• Have commenced building a lean commercial team in the US to support our distributor partnerships (more in the coming months)

• Commercial partnerships for 68Ga generator use and our ongoing collaborative efforts around cyclotron-produced 68Ga put Telix in a strong position to capture the US prostate imaging opportunity

• Excellent initial reference sites, such as MSKCC have helped build clinical visibility

• Further visibility and traction through the Endocyte VISION trial

• Sales of the illumet kit as an investigational product will generate initial revenues for Telix based on considerable clinician interest*

• Most clinical customers are capable of imaging 5-10 patients / wk

14*68Ga-PSMA-11 is an investigational product in the United States andhas not received marketing authorization from the US Food and Drug Administration (FDA)

www.telixpharma.com