Telix Pharmaceuticals Ltd — Interim / Quarterly Report 2021

Aug 18, 2021

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Precision Oncology See it. Treat it.

Telix Pharmaceuticals Limited Half-Year Shareholder Update (1H21)

19 August 2021

Disclaimer

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The information contained in this presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (“Telix”) in any jurisdiction, including the United States. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained in this document or opinions expressed in the course of this presentation. The information contained in this presentation is subject to change without notification.

This presentation may contain forward-looking statements which can be identified by the use of words such as “may”, “should”, “will”, “expect”, “anticipate”, “believe”, “estimate”, “intend”, “scheduled” or “continue” or similar expressions. Any forward-looking statements contained in this presentation are subject to significant risks, uncertainties, assumptions, contingencies and other factors (many of which are outside the control of, and unknown to Telix, and its directors, officers, employees, agents or associates), which may cause the actual results or performance to be materially different from any future result so performed, expressed or implied by such forward-looking statements.

There can be no assurance or guarantee that actual outcomes will not differ materially from these statements. The data and results pertaining to clinical subjects used in this presentation are illustrative of medical conditions and outcomes associated with potential applications of Telix’s product pipeline. Actual results from clinical trials may vary from those shown. None of the products or potential products described in this presentation have received a marketing authorisation in any jurisdiction, with the exception of Scintimun[®1]

1. Scintimun® is a registered trademark of Curium Pharma

Telix Pharmaceuticals Limited (ASX: TLX)

Telix: A global leader in radiopharmaceuticals

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Extensive, clinically-validated portfolio of diagnostic and therapeutic assets

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[patient doses in past 12 months][1] 11,000

17 countries with a marketing authorisation for TLX591-CDx (illuccix[®] ) in progress 17 active clinical trials (7 indications)[2]

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Leading supply chain and distribution network 80 countries in the Telix distribution network

11[countries with a manufacturing footprint]

1. Clinical trial doses and magisterial / compassionate use of TLX591-CDx.

2. Includes partnered investigator-led studies.

Telix Pharmaceuticals Limited (ASX: TLX)

Our strategy: See It. Treat it.

Targeted radiation delivery Systemically administered

Unique cancer cell signature (target)

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Radioactive isotope

Targeting agent (a small molecule or antibody) binds selectively to a cancer cell

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Imaging

TLX591-CDx[1] (Prostate cancer)

PET scanner

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68Ga, 89Zr (diagnostic isotopes) Enables PET images of cancer

TLX591

Therapy

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(Prostate cancer)

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177Lu, 131I, 225Ac (therapeutic isotopes)

Enables precise radiation delivery to the cancer

1. Courtesy of Ammar Chaudhry MD, City of Hope, Duarte CA, USA.

Telix Pharmaceuticals Limited (ASX: TLX)

Deep pipeline in oncology, rare diseases

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Shaded arrows indicate completion expectations in the next 12 months.

1. Prostate-specific membrane antigen.

2. Carbonic anhydrase IX.

3. Bone marrow conditioning and rare disease. 5. Cluster of differentiation 66.

4. Large amino acid transporter 1.

Telix Pharmaceuticals Limited (ASX: TLX)

Isotope and manufacturing supply chain matters

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Half-life
99mTc 6 hours Centralised
(TLX599-CDx, TLX66-CDx) 131I 8 days
manufacturing
(TLX101)
110 mins Network-based
18F 2.7 days
(TLX101-CDx) manufacturing 90Y
(TLX66)
(multi-site) 177Lu 6.7 days
(TLX250, TLX591)
68 mins
68Ga
(TLX591-CDx)
89Zr 3.3 days
(TLX250-CDx)
10,000 clinical doses annually (commercial capacity threshold)
225although global supply chains are Ac is promising for alpha therapy, 225Ac 10 days
(TLX592)
still developing
64Cu half-life too short for centralised
manufacturing and not cost effective
for network manufacturing either
64Cu 67Ga 3.3 days
211 13 hours
At will require cyclotron 67
networks – or co-localisation 211At 7 hours 67Cu Cu has similar emission profile to
2.6 days 177
Lu but no commercial availability
at specialty treatment centres
Short (Hours) Long (Days)
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Therapeutic Nuclide

68 Diagnostic Ga Nuclide

Short (Hours)

Half-life

Telix Pharmaceuticals Limited (ASX: TLX)

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1H21 Highlights

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Operational highlights

Momentum and focus leading into key inflection points

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US FDA decision on 23 September 2021

Launch illuccix[®]

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Phase III imaging trial in renal cancer, Complete Breakthrough Designation, ZIRCON and year-end completion

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Phase III therapy trial initiated in Commence metastatic castrate resistant ProstACT prostate cancer (mCRPC)

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• Launch ready

• TGA and EU approvals to follow by yearend

• Enrolment expected to complete by yearend, recruitment accelerating

• FDA BLA[2] consultation process to commence by year-end

• Initial launch in Australia (CTN[3] /ethics)

• US/EU site selection underway

• Expanded ProstACT program launched to support future indication expansion

• Biologics Licence Application

• Clinical Trial Notification

Telix Pharmaceuticals Limited (ASX: TLX)

Investing for commercial launch and pipeline expansion

June 2021 June 2021 Cash June 2021 Product-Related Reserves R&D Investment Revenue

+103%

+59%

+81% $2.9M

$13.7M

$49.6M

June 2020 $8.6M

June 2020 $24.4M

June 2020 $1.6M

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June 2021 Comprehensive Loss

+90%

$33.4M

June 2020 $17.6M

Telix Pharmaceuticals Limited (ASX: TLX)

Pre-approval revenue as kit sales recover from COVID-19 impact

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TLX591-CDx Kit Sales (Jul 20 – Jun 21)

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3000
2500
2,384
2000
1,841
1500
1000
500
0
2H20 1H21
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Delivering at commercial scale:

• Growing user base with 2,384 kits sold (investigational, clinical trial, magisterial and compassionate use access only) up 30% from 2H20

• Equivalent to approximately 6,200 individual patient doses (multi-dose kit)

Early revenue generation validates the product:

• Telix received $1.8M in cash receipts from customers in 1H21

• Average kit pricing remained stable on a territory-byterritory basis

Telix Pharmaceuticals Limited (ASX: TLX)

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Illuccix[®] Imaging Ready to launch

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Illuccix[®] approval timelines (estimated)

US FDA approval decision (PDUFA[1] action date) of 23 September 2021

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1. Prescription Drug User Fee Act

Telix Pharmaceuticals Limited (ASX: TLX)

Planned US illuccix[®] roll-out : The gallium wave

www.galliumwave.com

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• Superior network coverage at launch

• On-demand pharmacy-based production with a high yield product

• Customer and patient scheduling flexibility – we give control back to the customer

Telix-Partner Sites Current Competitor Sites

Illuccix[®] (Kit for the preparation of[68] Ga-PSMA-11) is an investigational product and has not attained a marketing authorisation in any jurisdiction, including the United States. Product launch in the United States is subject to FDA approval of a New Drug Application (NDA)

Telix Pharmaceuticals Limited (ASX: TLX)

Planned US illuccix[®] roll-out: Ready to launch

Ready for commercial-scale delivery

• Telix + partners will have the largest commercial team (including sales, market access, MSL) to service the US prostate imaging market

Multi-disciplinary commercial team

• Direct sales force hired and cross-trained in both oncology and nuclear medicine aspects

• ~90% of eligible PET sites will have access to illuccix[®] upon approval

Superior site

• Multiple sales targets : referring physicians, B2B collaboration, PET imaging sites and active profiling to potential early adopters

coverage

• Market access strategy in place

• Generator capacity in place

Manufacturing capacity to meet expected demand

• Pharmacy network manufacturing, close to our customer, gives sites complete control over patient management and scheduling for maximum flexibility

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Telix Pharmaceuticals Limited (ASX: TLX)

US$900M total addressable market for illuccix[®]

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478,000 [2]
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Annual incidence of prostate cancer in Telix US & EU markets[1]

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386,000
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Patients with prostate cancer eligible for PET imaging with TLX591-CDx (illuccix[®] ), across 4 potential indications

1. Biochemical recurrence following prostatectomy or radiation therapy 2. Patient selection for PSMA targeted radio-ligand therapy (RLT)

2. Primary staging in newly diagnosed high-risk prostate cancer 4. Monitoring of response to systemic therapy

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USD $900M [3]
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Total addressable market (TAM) value

1. Telix markets = US + EU countries included in MAA submission to Danish Medicines Authority on 30th April 2020.

2. GLOBOCAN 2020 reported incidence of prostate cancer in Telix’s markets.

3. US TAM value = USD $575M, EU TAM value = USD $325M.

Telix Pharmaceuticals Limited (ASX: TLX)

Global launch backed by strong commercial partnerships

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Telix Pharmaceuticals Limited (ASX: TLX)

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Renal Cancer Imaging Building a high value genitourinary (GU) oncology portfolio

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Building a high-value portfolio in GU oncology

“Breakthrough Therapy” designation, clinical leadership opportunity

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• TLX250-CDx is an investigational product being developed for imaging of clear cell renal cell carcinoma (ccRCC) with PET

• Potential to deliver on unmet need for improved staging of ccRCC

• Identifies “indeterminate renal masses” through improved, whole of body imaging and optimising opportunity for minimally invasive treatment options

• Mission is to build on illuccix[®] GU oncology customer base with a second high-value product

• BLA consultation process to commence by end-year

• Limited commercial competition, high unmet medical need

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Whole body scan of a 57-year-old male patient revealing 3 lesions. Only those at renal and adrenal level (lower 2 arrows) were also detected on CT. Merkx et al, EJNMMI, 2021.

Telix Pharmaceuticals Limited (ASX: TLX)

ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC

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Surgical removal &
histology as standard
of truth
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• Eligible Patients

• • Single indeterminate renal mass ≤8cm diameter on CT or MRI suspicious for ccRCC

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TLX250-CDx PET/CT scan

• Scheduled for surgical remove as part of diagnostic plan

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• International, multi-centre, Phase III trial in ~252 patients with an indeterminate renal mass suspicious of ccRCC

• Primary endpoint: Sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth

• 34 sites participating

• Recruitment accelerating (COVID impact) with completion of enrolment expected by end-year

• United States, Canada, Europe, Turkey, Australia

• ZIRDAC-JP Phase I/II bridging trial of TLX250-CDx in Japan

• Phase I objectives met, Phase II in planning, potential to include Chinese patients to expand Asian utility

Telix Pharmaceuticals Limited (ASX: TLX)

TLX250-CDx: Delivering an unmet need in renal cancer imaging

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• Total addressable market value in US and Europe estimated at US$3-400M

• Low competition, opportunity for market leadership in renal cancer

• Addresses a major unmet medical need

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Yearly estimated
Yearly new cases,
number of deaths,
worldwide, both
worldwide, both
sexes, all ages
sexes, all ages
431,288
179,368
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Telix Pharmaceuticals Limited (ASX: TLX)

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Prostate Cancer Therapy Our vision for prostate cancer

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ProstACT program overview

Expanded program will add value and clinical insight to TLX591 platform

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Radiogenomics study (Phase I)

• Australia & NZ

• 30-50 patients

• First line mCRPC

Combination with EBRT in oligometastatic early recurrence (Phase II)

• Australia

• 50 patients

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Treat the scan

Correlation between imaging and therapy to optimise patient selection

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Early data in front line care

Efficacy data in patients in their first recurrence

• SELECT – radiogenomics study enhances patient selection and supports indication expansion based on a “theranostic” approach

• TARGET – in partnership with GenesisCare, evaluates TLX591 in a front-line setting

• Co-funded by GenesisCare

Pivotal Phase III study in patients with mCRPC progressing on 1st line novel androgen agents

• International

• 390 patients

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TLX591 + Standard of Care (SoC) vs. SoC alone

• GLOBAL – Multiple data readouts throughout the ProstACT program duration

• Growing pharma engagement and collaboration (i.e. Merck)

• Second line mCRPC

Telix Pharmaceuticals Limited (ASX: TLX)

TLX591 differentiation

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Antibody vs small molecule

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Significantly improved overall survival; cross-trial comparison of 40+ months vs. 15.3 months in a comparable end-stage patient population[[1,2 ]]

Eff ~~icacy~~ 15.3 months in a comparable end-stage patient population[[1,2 ]] Reduced potential for undesirable side-effects; dry eye, xerostomia (salivary gland Patient co ~~mfort~~ ablation), back pain (ganglia irradiation) Patient-centric Short treatment duration/significantly fewer hospital visits – two weeks total vs. 36 regimen weeks, supports close supervision by medical oncology Reduced[177] Lu isotope requirement via more targeted dosing/less waste Cost eff ~~ective~~ COGS ~1/5 of competition, expected to also be available in “cold kit” format

Reduced potential for undesirable side-effects; dry eye, xerostomia (salivary gland ablation), back pain (ganglia irradiation)

1. Tagawa et al, Cancer 2019.

2. Cross-trial comparison, randomised controlled trial (RCT) required for verification.

Telix Pharmaceuticals Limited (ASX: TLX)

TLX591 patient experience

Off-target irradiation – quality of life matters

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TLX591 Small molecule
Lacrimal, Parotid,
Submandibular
Antibodies are functionally (salivary) glands Small molecule
specific for tumour-expressed radioligands taken
PSMA and do not “hit” most up by endogenous
endogenous PSMA expression PSMA
Spleen, Liver
Additional off-target
Liver (preferred effects with small
Kidneys,
clearance organ)
Small bowel molecule radioligands
(not experienced with
Fecal excretion TLX591)
•
Bladder Dry eye
•
(urinary excretion) Xerostomia
•
Back pain from
ganglia irradiation
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Data courtesy of Prof. Neil Bander, WCMC.

Telix Pharmaceuticals Limited (ASX: TLX)

Telix’s dual approach for prostate cancer therapy

TLX592 ([225] Ac-TLX592)

TLX591 ([177] Lu-rosopatamab)

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Traditional humanised antibody immunoconjugate Well-validated for beta emitters

Re-engineered antibody immunoconjugate (RADmAb[®] )

Designed for delivering targeted alpha emitters

• Beta emitter ([177] Lu) suited to bulky metastatic disease

  • Alpha emitter ([225] Ac) intended for

• Telix is building on a significant body of clinical data

• ~200 PC patients in five Phase I and II studies

• Early-stage metastatic disease (e.g. BCR[2 ] )

• Late-stage disease following[177] Lu-PSMA therapy

• Demonstrates significant therapeutic impact[1]

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1. Tagawa et al. Cancer 2019.

2. Biochemical recurrence.

3. First patient dosed August 2021

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Telix Pharmaceuticals Limited (ASX: TLX)

Prostate cancer: The patient journey

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Localised disease

Radiation therapy +/- ADT PSA Radical proctectomy Active surveillance

level

Advancing clinical stages

Docetaxel, abiraterone (metastatic, non-castrate), apalutamide, enzalutamide (non-metastatic, castrate resistant)

Metastatic castrate resistant

First line:

Docetaxel; Sipuleucel-T; Abiraterone Enzalutamide; Pembrolizumab

Rising PSA

ADT (non-castrate)

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Second line +
Clinical trial
Second line:
Cabazitaxel; Abiraterone
Enzalutamide; Radium 223
Pembrolizumab; Olaparib;
Rucaparib
Asymptomatic Symptomatic
Non-metastatic Metastatic
Castration-sensitive Castration-resistant
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Time / disease progression
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Telix Pharmaceuticals Limited (ASX: TLX)

Our clinical mission: Support the patient every step of the way

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Metastatic castrate resistant

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Localised disease Advancing clinical stages
Radiation therapy +/- ADT Docetaxel, abiraterone (metastatic, First line:
PSA Radical proctectomy non-castrate), apalutamide, enzalutamide Docetaxel; Sipuleucel-T; Abiraterone
level Active surveillance (non-metastatic, castrate resistant) Enzalutamide; Pembrolizumab PSMA-617 failures
68Ga / 99mTc
imaging
Rising PSA
Radiogenomics and
ADT (non-castrate)
tumour targeting of
TLX591
Combination of EBRT
and TLX591 in early
biochemical recurrence Second line +
Clinical trial
Second line:
TLX592 ( [225] Ac) Cabazitaxel; Abiraterone
Enzalutamide; Radium 223
Pembrolizumab; Olaparib;
Rucaparib
Pivotal Phase III study in patients with
mCRPC progressing on 1st line novel
androgen agents
Asymptomatic Symptomatic
Non-metastatic Metastatic
Castration-sensitive Castration-resistant
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PSMA-617 failures

Time / disease progression

Telix Pharmaceuticals Limited (ASX: TLX)

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Outlook

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We are pioneering a new oncology modality

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Glioblastoma

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Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx
I/II		TLX101	Tx

Breast Cancer

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Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx
II	OPALESCENCE	TLX250-CDx	Dx
II	Emory University	TLX591-CDx	Dx

Lung Cancer

Ph Name Asset Dx/Tx I Royal Adelaide (IIT) APOMAB Dx/Tx Lung Cancer	Ph Name Asset Dx/Tx I Royal Adelaide (IIT) APOMAB Dx/Tx Lung Cancer	Ph Name Asset Dx/Tx I Royal Adelaide (IIT) APOMAB Dx/Tx Lung Cancer	Ph Name Asset Dx/Tx I Royal Adelaide (IIT) APOMAB Dx/Tx Lung Cancer
I	Royal Adelaide (IIT)	APOMAB	Dx/Tx

Bone Marrow Conditioning

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Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx
I/IIa		TLX66	Tx

Bladder Cancer

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Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx
I	ZiP-UP	TLX250-CDx	Dx

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Renal Cancer

Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx
III		TLX250-CDx	Dx
I/II		TLX250-CDx	Dx
II		TLX250	Tx
II		TLX250	Tx

Prostate Cancer

Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx	Ph Name Asset Dx/Tx
III	University of Linz (IIT)	TLX591-CDx	Dx
II	Emory University (IIT)	TLX591-CDx	Dx
II		TLX591-CDx	Dx
II	Mem. Sloan Kettering (IIT)	TLX591-CDx	Dx
N/A*		TLX599-CDx	Dx
III		TLX591	Tx
I		TLX592	Tx

*Registry study

Telix Pharmaceuticals Limited (ASX: TLX)

Summary

Momentum and focus leading into key inflection points

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US FDA decision 23 September 2021

Launch illuccix[®]

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Phase III imaging trial in renal cancer, Breakthrough Designation, and year-end completion

Complete ZIRCON

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Phase III therapy trial initiated in metastatic castrate resistant prostate cancer (mCRPC)

Commence ProstACT

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• Launch ready

• TGA and EU approvals to follow by yearend

• Enrolment expected to complete by yearend, recruitment accelerating

• FDA BLA consultation process to commence by year-end

• Initial launch in Australia (CTN/ethics)

• US/EU site selection underway

• Expanded ProstACT program launched to support future indication expansion

Telix Pharmaceuticals Limited (ASX: TLX)

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telixpharma.com

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