Slide 1: Half-Year Shareholder Update (1H21)
Precision Oncology See it. Treat it. Telix Pharmaceuticals Limited Half-Year Shareholder Update (1H21) 19 August 2021
Slide 2: Disclaimer
Disclaimer 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 implie
Slide 3: Telix: A global leader in radiopharmaceuticals
Telix: A global leader in radiopharmaceuticals Extensive, clinically-validated portfolio of diagnostic and therapeutic assets 11,000 patient doses in past 12 months 1 17 countries with a marketing authorisation for TLX591-CDx (illuccix ) in progress ® 17 active clinical trials (7 indications) 2 Lead
Slide 4: Our strategy: See It. Treat it.
Our strategy: See It. Treat it. Targeted radiation delivery Systemically administered Imaging PET scanner TLX591-CDx1 (Prostate cancer) Unique cancer cell signature (target) 68Ga, 89Zr (diagnostic isotopes) Enables PET images of cancer Therapy TLX591 (Prostate cancer) Radioactive isotope Targeting a
Slide 5: Deep pipeline in oncology, rare diseases
Deep pipeline in oncology, rare diseases Shaded arrows indicate completion expectations in the next 12 months. 1. Prostate-specific membrane antigen. 4. Bone marrow conditioning and rare disease. 2. Carbonic anhydrase IX. 5. Cluster of differentiation 66. 3. Large amino acid transporter 1. Telix Pha
Slide 6: Isotope and manufacturing supply chain matters
Isotope and manufacturing supply chain matters Half-life 6 hours Centralised 99mTc (TLX599-CDx, TLX66-CDx) 8 days manufacturing 131I (TLX101) 110 mins Network-based Commercial Isotope / Supply Chain Maturity 18F 2.7 days (TLX101-CDx) manufacturing 90Y (TLX66) 6.7 days (multi-site) 177Lu (TLX250, TLX
Slide 7: 1H21 Highlights
1H21 Highlights
Slide 8: Operational highlights
Operational highlights Momentum and focus leading into key inflection points Launch ready Launch US FDA decision on TGA and EU approvals to follow by year- illuccix® 23 September 2021 end Enrolment expected to complete by year- Phase III imaging trial in renal cancer, Complete Breakthrough Des
Slide 9: Investing for commercial launch and pipeline expansion
Investing for commercial launch and pipeline expansion June 2021 June 2021 Cash June 2021 June 2021 Product-Related Reserves R&D Investment Comprehensive Loss Revenue +81% +103% +59% +90% $2.9M $49.6M $13.7M $33.4M June 2020 June 2020 June 2020 June 2020 $1.6M $24.4M $8.6M $17.6M Telix Pharmaceutica
Slide 10: Pre-approval revenue as kit sales recover from COVID-19 impact
Pre-approval revenue as kit sales recover from COVID-19 impact TLX591-CDx Kit Sales (Jul 20 – Jun 21) 3000 Delivering at commercial scale: 2500 • Growing user base with 2,384 kits sold (investigational, 2,384 clinical trial, magisterial and compassionate use access only) up 30% from 2H20 2000 • Equi
Slide 11: Illuccix Imaging
Illuccix® Imaging Ready to launch
Slide 12: Illuccix approval timelines (estimated)
Illuccix® approval timelines (estimated) US FDA approval decision (PDUFA1 action date) of 23 September 2021 1. Prescription Drug User Fee Act Telix Pharmaceuticals Limited (ASX: TLX) 12
Slide 13: Planned US illuccix roll-out: The gallium wave
Planned US illuccix® roll-out : The gallium wave www.galliumwave.com • 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
Slide 14: Planned US illuccix roll-out: Ready to launch
Planned US illuccix® roll-out: Ready to launch Ready for commercial-scale delivery • Telix + partners will have the largest commercial team (including sales, Multi-disciplinary market access, MSL) to service the US prostate imaging market commercial team • Direct sales force hired and cross-trained
Slide 15: US$900M total addressable market for illuccix
US$900M total addressable market for illuccix® Annual incidence of prostate cancer in Telix US & EU markets1 478,0002 Patients with prostate cancer eligible for PET imaging with TLX591-CDx (illuccix®), across 4 potential indications 1. Biochemical recurrence following prostatectomy or radiation ther
Slide 16: Global launch backed by strong commercial partnerships
Global launch backed by strong commercial partnerships Telix Pharmaceuticals Limited (ASX: TLX) 16
Slide 17: Renal Cancer Imaging
Renal Cancer Imaging Building a high value genitourinary (GU) oncology portfolio
Slide 18: Building a high-value portfolio in GU oncology
Building a high-value portfolio in GU oncology “Breakthrough Therapy” designation, clinical leadership opportunity • 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 c
Slide 19: ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC
ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC Eligible Patients • Single indeterminate renal mass ≤8cm diameter Surgical removal & TLX250-CDx on CT or MRI suspicious for ccRCC histology as standard PET/CT scan • Scheduled for surgical remove as part of of truth diagnostic plan • Internat
Slide 20: TLX250-CDx: Delivering an unmet need in renal cancer imaging
TLX250-CDx: Delivering an unmet need in renal cancer imaging • Total addressable market value in US and Europe estimated Yearly estimated Yearly new cases, at US$3-400M number of deaths, worldwide, both worldwide, both sexes, all ages • Low competition, sexes, all ages opportunity for market leaders
Slide 21: Prostate Cancer Therapy
Prostate Cancer Therapy Our vision for prostate cancer
Slide 22: ProstACT program overview
ProstACT program overview Expanded program will add value and clinical insight to TLX591 platform Radiogenomics study (Phase I) • SELECT – radiogenomics • Australia & NZ study enhances patient • 30-50 patients Treat the scan Correlation between imaging and therapy to selection and supports • First l
Slide 23: TLX591 differentiation
TLX591 differentiation Antibody vs small molecule Efficacy Significantly improved overall survival; cross-trial comparison of 40+ months vs. 15.3 months in a comparable end-stage patient population1,2 Reduced potential for undesirable side-effects; dry eye, xerostomia (salivary gland Patient comfort
Slide 24: TLX591 patient experience
TLX591 patient experience Off-target irradiation – quality of life matters TLX591 Lacrimal, Parotid, Small molecule 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
Slide 25: Telix's dual approach for prostate cancer therapy
Telix’s dual approach for prostate cancer therapy TLX591 (177Lu-rosopatamab) TLX592 (225Ac-TLX592) Traditional humanised antibody immunoconjugate Re-engineered antibody immunoconjugate (RADmAb®) Well-validated for beta emitters Designed for delivering targeted alpha emitters • Beta emitter (177Lu) s
Slide 26: Prostate cancer: The patient journey
Prostate cancer: The patient journey Localised disease Advancing clinical stages Metastatic castrate resistant Radiation therapy +/- ADT Docetaxel, abiraterone (metastatic, First line: PSA Radical proctectomy non-castrate), apalutamide, enzalutamide Docetaxel; Sipuleucel-T; Abiraterone Active survei
Slide 27: Our clinical mission: Support the patient every step of the way
Our clinical mission: Support the patient every step of the way Localised disease Advancing clinical stages Metastatic castrate resistant Radiation therapy +/- ADT Docetaxel, abiraterone (metastatic, First line: PSA Radical proctectomy non-castrate), apalutamide, enzalutamide Docetaxel; Sipuleucel-T
Slide 28: Outlook
Outlook
Slide 29: We are pioneering a new oncology modality
We are pioneering a new oncology modality Renal Cancer Glioblastoma Ph Name Asset Dx/Tx Ph Name Asset Dx/Tx III TLX250-CDx Dx I/II TLX101 Tx I/II TLX250-CDx Dx Breast Cancer II TLX250 Tx Ph Name Asset Dx/Tx II TLX250 Tx II OPALESCENCE TLX250-CDx Dx II Emory University TLX591-CDx Dx Prostate Cancer L
Slide 30: Summary
Summary Momentum and focus leading into key inflection points US FDA decision Launch ready Launch TGA and EU approvals to follow by year- 23 September 2021 illuccix® end Enrolment expected to complete by year- Phase III imaging trial in renal cancer, end, recruitment accelerating Complete Brea
Slide 31: telixpharma.com
TELIX PHARMACEUTICALS Precision Oncology. See it. Treat it. telixpharma.com