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Telix Pharmaceuticals Ltd Investor Presentation 2021

Jun 1, 2021

31324_rns_2021-06-01_2765eb3f-284b-46f2-a70f-a06e6749c7c2.pdf

Investor Presentation

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Telix Pharmaceuticals Limited Jefferies Healthcare Conference

June 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.

Telix Pharmaceuticals Limited (ASX: TLX)

Telix at a glance…

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Extensive late stage product portfolio – diagnostics and therapeutics

ü Oncology with focus on prostate, renal, glioblastoma, hematologic cancers

  • ü Immunology applications and high value rare diseases

Major milestones achieved during 2020…despite COVID-19

  • ü Illuccix[® ] (prostate cancer imaging):

  • Regulatory filings in US, EU, Canada, Australia

  • Commercial distribution agreements in US (Cardinal Health and Pharmalogic) and major EU & APAC territories

  • ü Licensed production facility acquired in Seneffe, Belgium from Eckert & Ziegler AG

  • ü China Grand Pharma transaction: Up to $400M+ value, delivers long-term clinical & commercial partner for Greater China region

  • ü TheraPharm acquisition: Broadens development pipeline to hematologic oncology, bone marrow transplantation, rare diseases ü Multiple strategic collaborations: Varian Medical Systems, RefleXion, Mauna Kea Technologies

Significant inflection points in 2021

  • ü Illuccix[® ] : Regulatory approval and commercial launch in US, EU, Canada, Australia. First commercial product revenue

  • ü Second product: Completion of ZIRCON Phase III trial of TLX250-CDx (renal cancer imaging)

  • ü Therapeutics: Launch ProstACT Phase III trial of TLX591 (prostate cancer therapy) in Australia, EU, US

  • ü Extend global reach: Asia, Latin America – currently clinically active in 30+ countries

Telix Pharmaceuticals Limited (ASX: TLX)

Our technology : Molecularly-Targeted Radiation (MTR) See It. Treat it.

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Targeted radiation delivery Systemically administered

Unique cancer cell signature (target) Radioactive isotope

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

Imaging

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PET scanner TLX591-CDx [1]
(Prostate cancer)
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68Ga, 89Zr (diagnostic isotopes) Enables PET images of cancer

Therapy TLX591 (Prostate cancer) 177Lu, 131I, 225Ac (therapeutic isotopes) Enables precise radiation delivery to the cancer

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Therapy
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  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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||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|Targeting|Cancer Cell|Radioactive|
|Molecule|Target|Isotope|Phase I|Phase II|Phase III|Commercial|
|Small|PSMA|68Ga|TLX591-CDx (|[68]|Ga-PSMA-11, Illuccix|[®]|)|Imaging|
|molecule|
|Antibody|PSMA|177Lu|TLX591 (|[177]|Lu–rosopatamab)|Therapy|
|Antibody|PSMA|225Ac|TLX592 (|[225]|Ac–RADmAb|[®]|)|Therapy (2|[nd]|Gen)|
|Small|
|molecule|PSMA|99mTc|TLX599-CDx (|[99m]|Tc-iPSMA)|Imaging / Surgery|
|Small|
|molecule|PSMA|68Ga|TLX591-Sx (|[68]|Ga-PSMA-IRDye)|Imaging / Surgery|
|Antibody|CA9|89Zr|TLX250-CDx (|[89]|Zr–girentuximab)|Imaging|
|Antibody|CA9|177Lu|TLX250 (|[177]|Lu–girentuximab)|Therapy|
|Small|LAT1|18F|TLX101-CDx (|[18]|F-FET)|Imaging|
|molecule|
|Small|
|molecule|LAT1|131I|TLX101 (|[131]|I-IPA)|Therapy|
|Antibody|CD66|99mTc|TLX66-CDx (|[99m]|Tc-besilesomab, Scintimun|[®2]|)|ImagingImaging|
|Antibody|CD66|90Y|TLX66 (|TLX591|[90]|Y-besilesomab)|Therapy|

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  1. Bone marrow conditioning / rare diseases.

Shaded arrows indicate expected development stage in the next 12 months.

  1. Scintimun[®] is a registered trademark of Curium Pharma. Telix Pharmaceuticals Limited (ASX: TLX)

Board of Directors : Medical, radiopharmaceutical, risk and governance experience

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Indianapolis
Liège
(USA)
(Belgium) Kyoto
(Japan)
Brisbane
Sydney
Melbourne
(Global HQ)
Co-founders:
Dr. Christian Behrenbruch (MD and CEO, Melbourne)
Dr. Andreas Kluge (Director, Dresden)
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Dr. Christian Behrenbruch (MD and CEO, Melbourne) Dr. Andreas Kluge (Director, Dresden)

Chairman

Mr. Kevin McCann, AO

Chairman of China Matters, a Pro-Chancellor of the University of Sydney, a Trustee of the Sydney Opera House, Director of E&P Financial Services Group. Former Chairman of Macquarie, Origin Energy, Healthscope, ING Management Limited, Allens partner.

Non-Executive Director

Ms. Jann Skinner

Former PwC partner, Director of QBE Insurance (Chair audit committee), Create Foundation Limited and HSBC Bank Australia Limited.

Non-Executive Director

Dr. Mark Nelson

Chairman/Co-Founder of the Caledonia Investments Group. Chairman of Art Exhibitions Australia, Director of Kaldor Public Art Projects, The Mindgardens Neuroscience Network, and a Governor of the Florey Neurosciences Institute.

Non-Executive Director

Mr. Oliver Buck

Oliver has served as founder and management of multiple companies in manufacturing, technology, pharmaceuticals and IT. He is the co-founder of ITM Isotopen Technologien München AG, a leading isotope manufacturing and distribution company.

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Telix Pharmaceuticals Limited (ASX: TLX)

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Telix Pharmaceuticals Limited (ASX: TLX)

Flagship product : TLX591-CDx (Illuccix[®] ) prostate cancer imaging

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New Drug Application (NDA) submitted to the US FDA in September 2020[1]

  • NDA accepted for filing in December 2020, currently in review

  • FDA mid-cycle review meeting occurred on the 2[nd] March 2020

  • Late-cycle review meeting scheduled for mid-June

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  • No major issues identified following initial FDA assessment and no plan by FDA to conduct an advisory committee meeting

  • Seeking an indication for the imaging of prostate cancer, from the early pre-treatment setting through to the later stages of advanced disease

  • US commercial partners, including Cardinal Health and Pharmalogic provide access to ~95% of US hospital beds

  • FDA approval expected second half of 2021[2]

  • United States Food and Drug Administration.

  • Subject to satisfying the necessary approval requirements.

Telix Pharmaceuticals Limited (ASX: TLX)

Planned US Illuccix[®] roll-out : the “gallium wave”

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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).

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Superior network
coverage at launch

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

Customer and
patient scheduling Telix
flexibility Partners
Competition
Puerto Rico, Alaska,
Hawaii not shown
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Telix Pharmaceuticals Limited (ASX: TLX)

EU marketing authorisation application for TLX591-CDx (Illuccix[®] )

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Marketing Authorisation Application submitted in April 2020

  • Danish Medicines Agency serves as the reference Competent Authority for Telix’s submission

  • 14 EU member countries included in Telix’s submission, including the ‘EU5’ (+UK)

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  • Broad indication for the imaging of recurrent prostate cancer

  • Temporary authorisations in some EU member states are expected ahead of full MAA approval

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  • ü Czech Republic authorised national (STP[1] ) use of TLX591-CDx for a broad prostate cancer imaging indication (February 2021)

  • ü Other countries in progress

  • Estimated EU MAA approval (country-by-country) commencing Q3 2021[2]

  • Specific Therapeutic Programme. https://www.sukl.eu/pharmaceutical-industry/related-information.

  • Subject to satisfying the necessary regulatory approvals.

Telix Pharmaceuticals Limited (ASX: TLX)

Regulatory submissions for TLX591-CDx (Illuccix[®] ) in other markets

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Telix is working towards a global product launch[1]

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  • Granted Priority Review status by Australian TGA in December 2020[2]

  • TGA submission accepted April 2021, with 150-day dossier review and approval

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  • New Drug Submission (NDS) filed with Health Canada in December 2020

  • NDS accepted for review, anticipate Canadian approval with broad indication Q4 2021

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  • Swissmedic filing in progress

  • Important jurisdiction for countries following EU/Swiss regulatory approvals

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  • Japanese ‘bridging’ study for TLX591-CDx has commenced at Kanazawa University

  • Data facilitates planning discussions with PMDA for approval in Japan[3]

  • Subject to satisfying the necessary regulatory approvals in each jurisdiction.

  • Pharmaceutical and Medical Device Agency.

  • Therapeutic Goods Administration.

Telix Pharmaceuticals Limited (ASX: TLX)

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Illuccix[® ] approval timelines (estimated)

2020 2021 Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Filing 24/11 02/03 Review 16/06 Decision 23/09 Acceptance Mid-cycle Late-cycle PDUFA Action Date review review (latest date) National Assessment 3/12 Clock-stop / review of feedback 03/06 Review 16/09 phase Acceptance Review Notification of continues decision Application for priority 07/12 Filing 14/04 Review 15/10 12/11 review Granted Submission ACM[1] Approval priority review accepted outcome Filing / consultation 16/12 Screening 16/02 Review 15/09 Decision Submission Preliminary Notification of completed acceptance decision

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  1. Advisory Committee on Medicines.

Telix Pharmaceuticals Limited (ASX: TLX)

For prostate cancer imaging with TLX591-CDx (Illuccix[®] ) the total addressable market (TAM) is ~USD $900M

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Annual incidence of prostate cancer in Telix’s US & EU markets [1] 478,000 [2]
Patients with prostate cancer eligible for PET imaging with TLX591-CDx
(Illuccix [®] ), across 4 potential indications
1. Biochemical recurrence following prostatectomy or radiation therapy 386,000
2. Patient selection for PSMA targeted radio-ligand therapy (RLT)
3. Primary staging in newly diagnosed high-risk prostate cancer
4. Monitoring of response to systemic therapy
Total addressable market (TAM) value USD $900M [3]
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  1. Telix’s markets = US + EU countries included in MAA submission to Danish Medicines Authority on 30[th] 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)

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ProstACT Phase III trial of TLX591 for the treatment of mCRPC[1]

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  • Pre-IND meeting with US FDA in November 2020 enabled ProstACT trial to be finalised

  • ü International, multi-centre, Phase III RCT[2] in ~390 patients with PSMA-expressing metastatic prostate cancer (mCRPC), experiencing disease progression following prior treatment with an anti-androgen drug (NAAD[3) ]

ü Primary endpoint: radiographic progression-free survival

  • ü Secondary endpoints include: overall Survival, quality of life, safety

  • ü 2:1 randomisation and enrichment of study population, patient selection with TLX591-CDx

  • ProstACT has been initiated in Australia and will progressively add EU and US sites during H2 2021, subject to satisfying the requisite approvals

  • Metastatic castration resistant prostate cancer.

  • Randomised controlled trial.

  • Novel androgen axis drug.

Telix Pharmaceuticals Limited (ASX: TLX)

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Telix Pharmaceuticals Limited (ASX: TLX)

ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC[1 ]

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NCT03849118
NCT03849118
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  • International, multi-centre, Ph III trial in ~252 patients with an indeterminate renal mass suspicious of ccRCC

  • ü 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

  • FDA approved Telix’s IND in January 2020 to enable ZIRCON to be conducted in US (COVID-19 delays)

  • FDA subsequently granted Breakthrough Therapy (BT) designation for TLX250-CDx in July 2020

  • ü Facilitates closer interaction with FDA and expedited approval process

  • 36 sites now participating, anticipate completion of patient recruitment mid-2021

  • ü US, Canada, Europe, Turkey, Australia

  • Commence FDA BLA submission process by year-end (2021)

  • Clear cell renal cell carcinoma.

Telix Pharmaceuticals Limited (ASX: TLX)

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

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Zirconium Dosing and Comparison in Japan

  • Japanese, multi-centre, Phase I/II trial in ~40 patients with an indeterminate renal mass suspicious for ccRCC

  • Primary endpoints NCT03849118

  • NCT03849118

  • ü Phase I – Safety and tolerability

  • ü Phase II – 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

  • Design aligned with global Phase III ZIRCON trial

  • Carefully designed in consultation with Japanese PMDA[1] to potentially bridge to the ZIRCON trial

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  • Pk/Pd[2] Phase I in 6 patients completed – study met all objectives

  • Phase II in planning, potential to include Chinese patients to expand Asian utility[3]

  • Pharmaceutical and Medical Devices Agency.

  • Subject to satisfying the necessary regulatory approvals.

  • Pharmacokinetics / pharmacodynamics.

Telix Pharmaceuticals Limited (ASX: TLX)

STARLITE Phase II trial of TLX250 for Treatment of ccRCC

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TLX250 in combination with immunotherapy

  • Phase II trial of TLX250 plus nivolumab in ~30 patients with ccRCC who have progressed following prior immunotherapy

NCT03849118 Primary endpoint NCT03849118

  • ü To determine the efficacy of combination therapy with[177] Lu-girentuximab (TLX250) as assessed by objective response rate

  • STARLITE program intended to be conducted at two US institutions was significantly impacted by COVID-19 and diversion of clinical research personnel away from usual research activities

  • FDA Investigational New Drug Application (IND) filing in progress

  • Patient recruitment expected to commence June/July[1]

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  1. Subject to satisfying the necessary regulatory approvals.

Telix Pharmaceuticals Limited (ASX: TLX)

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Telix Pharmaceuticals Limited (ASX: TLX)

IPAX-I Phase I/II trial of TLX101 for the treatment of GBM[1]

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TLX101 in combination with EBRT[2]

  • Multi-centre Phase I/II trial of TLX101 in combination with EBRT in up to 44 patients with recurrent GBM

NCT03849118 NCT03849118 ü Primary endpoint: Safety and tolerability

  • ü Secondary endpoints include: MTD[3] , efficacy, dosimetry

  • Promising initial data from lowest dose cohorts presented in Dec 2020

  • ü Initial treatment cohort, treated in single and triple fractions

  • ü Treatment well tolerated, predominantly grade 1 – 2 adverse events

  • ü Clear evidence of anti-tumour effect from both imaging and clinical assessment

  • Intend to accelerate dosing to determine optimal dose, to support consultation with regulatory authorities and pivotal trial design

  • ü Expand TLX101 program to US patients, IND in preparation

  • Glioblastoma Multiforme. 3. Maximum tolerated dose.

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Baseline PET scan

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Day 45 PET scan post TLX101 therapy

  1. External beam radiation therapy.

.

Telix Pharmaceuticals Limited (ASX: TLX)

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Telix Pharmaceuticals Limited (ASX: TLX)

TRALA Phase I/IIa trial of[90] Y-besilesomab (TLX66) in SALA[1 ]

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Ta R Am Li Am rgeted adiotherapy for yloid ght Chain yloidosis (TRALA)[2]

  • SALA

  • ü Rare disease with a poor prognosis (median survival ~11 months if untreated) NCT03849118

  • NCT03849118 ü Plasma cells in the bone marrow produce abnormal protein called ‘amyloid’ which accumulates in the organs and causes them to fail

  • ü Prevalence of ~30,000 to 45,000 patients in US and EU, ~US$600M TAM[3] in US and ‘EU5’

  • Current standard of care comprises induction therapy (cyclophosphamide, bortezomib, dexamethasone) plus high dose melphalan BMC[4] , followed by HSCT[5, 6]

  • TRALA study

  • ü Primary endpoint: Safety and toxicity of[90] Y-besilesomab as the sole BMC regime for autologous HSCT in patients with SALA

  • ü Study complete, preliminary data (9 pts) demonstrated 100% engraftment and high PR/CR[7] rate (5/2)

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Dysfunctional plasma cells

Free antibody light chain

Amyloid fibrils accumulate in organs

Organ failure, death

  1. Systemic amyloid light chain amyloidosis.

  2. https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002231-18/GB

  3. Total addressable market.

  4. Bone marrow conditioning.

  5. Hematopoietic stem cell transplant.

  6. Venner C, et al. Blood. (2012) 119 (19): 4387–4390.

  7. Partial response/complete response.

Telix Pharmaceuticals Limited (ASX: TLX)

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Telix Pharmaceuticals Limited (ASX: TLX)

Three major inflections in 2021

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Commence ProstACT Complete ZIRCON Launch Illuccix [®]
ZIRCON
Commence Phase III therapy trial Complete Phase III trial Regulatory approval
Australia initially (H1) BLA [1 ] preparation Commercial launch
EU and US (H2) Second commercial product First commercial revenue
Stakeholder Focus:
Become patient centric in everything we do. Become a revenue generating company.
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  1. Biologic license application.

Telix Pharmaceuticals Limited (ASX: TLX)

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telixpharma.com

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