Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — H1 2020 Earnings Presentation
34 slides from Telix Pharmaceuticals's earnings presentation, Aug 21, 2020
Slide 1: Half-Year Shareholder Update
Telix Pharmaceuticals Limited Half-Year Shareholder Update Dr. Christian Behrenbruch Managing Director and CEO 21st August 2020
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: Company Snapshot
Company Snapshot • Late-stage portfolio of Molecularly Targeted Radiation (MTR) products : ✓ Prostate cancer, renal cancer, glioblastoma ✓ Significant total addressable market value of US$850M & US$4B for prostate imaging and therapy, respectively ✓ Clinically active in 25 countries, global reach •
Slide 4: What is MTR? Precise Radiation Delivery
What is MTR? Precise Radiation Delivery 1. Targeted radiation delivery 2. Systemic administration 3. Dual benefit: imaging and therapy Radioactive Antibody or small molecule Isotope binds to a cancer cell Prostate cancer Renal cell carcinoma Glioblastoma (The “Payload”) (The “Targeting Molecule”) TL
Slide 5: 'See It. Treat It'
‘See It. Treat It’ See… Treat… Low dose / diagnostic High dose / therapeutic radionuclide and a PET radionuclide treats the patient scanner images the presence of the cancer Dosing and treatment target response guided by imaging TLX591 Telix Pharmaceuticals Limited (ASX: TLX) 5
Slide 6: Telix's Clinical Pipeline in Prostate, Kidney, Brain Cancer
Telix’s Clinical Pipeline in Prostate, Kidney, Brain Cancer Cancer Targeting Cell Radioactive Molecule Target Isotope Phase I Phase II Phase III Commercial Small Prostate 68Ga PSMA (2) TLX591-CDx (68Ga-PSMA-11) Imaging molecule Antibody PSMA 177Lu TLX591 TLX591 (177Lu–rosopatamab) Therapy Kidney Ant
Slide 7: Clinical and Commercial Activity
Clinical and Commercial Activity 7
Slide 8: Activity Focus Areas
Activity Focus Areas Commercialisation Pipeline of TLX591-CDx R&D (prostate imaging) Clinical Trials Telix Pharmaceuticals Limited (ASX: TLX) 8
Slide 9: Key Accomplishments Year to Date
Key Accomplishments Year to Date EU MAA submitted Phase III meeting Seneffe (Belgium) for TLX591-CDx with the FDA, site acquisition (prostate imaging), finalisation of completed for EU NDA preparation protocol manufacturing US/EU/AU recruitment, Multiple Active R&D including indication expansion, di
Slide 10: Financial Dashboard
Financial Dashboard H1 2020 H1 2020 H1 2020 H1 2020 Comprehensive Loss Receipts Program Costs Corporate / Employment Costs +70% +28% -33% $17.6m $2.1m $5.6m ~$2.5m / Qtr H1 2019: $10.4m H1 2019: $1.6m H2 2019: $8.3m Flat Telix Pharmaceuticals Limited (ASX: TLX) 10
Slide 11: Half Year Sales Review: TLX591-CDx / illumet
Half Year Sales Review: TLX591-CDx / illumet® (prostate imaging) TLX591-CDx Kit Sales, H1 2020 500 • Telix delivered approximately 4,600 450 individual patient doses prepared 400 432 from over 1,900 TLX591-CDx prostate cancer imaging kits 350 355 336 300 300 • Telix received $2.1m in cash receipts 2
Slide 12: Current Clinical Activity
Current Clinical Activity Development Stage Asset Indication Status Phase III Metastatic castrate-resistant Ph III IND preparation in progress TLX591 (Therapy) prostate cancer (mCRPC) – Q4 2020 planned start STARLITE Phase II (x2) (Therapy) TLX250 Metastatic clear cell renal cell cancer (ccRCC) IND(
Slide 13: COVID-19 Impact
COVID-19 Impact COVID-19 has had a significant impact on the operational and expenditure profile of the business • Clinical activity: most clinical activity paused March – August, some re- start of clinical activity for IPAX-1 and ZIRCON in Europe in July • Lower program-related (external) costs suc
Slide 14: EU Marketing Authorisation Status (TLX591-CDx)
EU Marketing Authorisation Status (TLX591-CDx) Telix has submitted an EU marketing authorisation application (MAA) for TLX591-CDx (prostate cancer imaging) • Submitted in April 2020, mostly based on pre-COVID-19 effort • Danish Medicines Agency (DKMA) agreed to serve as reference competent authority
Slide 15: US NDA Submission Status (TLX591-CDx / illumet)
US NDA Submission Status (TLX591-CDx / illumet®) Telix is in the final stages of preparing a New Drug Application (NDA) to the US FDA • Will be submitted this quarter (Q3) • Delays due to both COVID-19 and management decisions around expanding the product label based on FDA consultation and the avai
Slide 16: Other TLX591-CDx Jurisdictions in Progress
Other TLX591-CDx Jurisdictions in Progress TGA submission preparation in progress, expected to be submitted in Q4 2020. MSAC approval likely mid-2021 Routine provision of compassionate use access under HealthCanada requests. Currently preparing submission package Swissmedic application in progress.
Slide 17: ProstACT: Phase III Prostate Cancer Therapy
ProstACT: Phase III Prostate Cancer Therapy Valuable pre-Phase III meeting with the FDA completed (Q3) • Currently refining the clinical protocol based on FDA feedback • Very useful / positive feedback with respect to the use of imaging (TLX591-CDx) for patient selection and enrichment • Expect to s
Slide 18: Summary: Commercial and Clinical
Summary: Commercial and Clinical Despite COVID-19, H1 was highly active with significant commercial and program-related progress • Effective management of Telix’s financial resources despite major operational and clinical impact of COVID-19 • EU MAA submitted on time, US NDA delayed but on track for
Slide 19: R&D Progress
R&D Progress 19
Slide 20: Telix R&D Strategy
Telix R&D Strategy Telix’s innovation strategy combines both in-house technology platform development and collaboration with leading academic centres, with several key objectives: ✓ Product life cycle management to maintain category leadership ✓ Platform development – expanding the capabilities and
Slide 21: Meet the 'Extended Family'
Meet the ‘Extended Family’ Core R&D Enhancement Technology Collaborators Development Status Technology TLX102 : 211At “alpha” variant of Osaka University, Japan • FDA orphan drug granted TLX101 TLX101 for multiple myeloma University of Nantes, France • Preparing for first-in-human TLX591-Sx(1) : Add
Slide 22: TLX102: 211At-Phe Indication: Multiple Myeloma
TLX102: 211At-Phe Indication: Multiple Myeloma Innovation: • New chemistry to replace 131I in TLX101 with 211At (astatine) • High-specific activity chemistry, rapid synthesis – new IP portfolio, also benefits commercialisation of TLX101 Rationale: • LAT-1 is highly expressed in multiple myeloma but
Slide 23: TLX591-Sx: 68Ga-DYE-PSMA-11
TLX591-Sx: 68Ga-DYE-PSMA-11 Indication: Image-guided surgery for prostate cancer Innovation: • Extends the TLX591-CDx platform to a dual-modality tracer that combines PET imaging and optical (fluorescence) imaging in the same molecule • One injection – two images. PET and optical guidance for minima
Slide 24: TLX599-CDx: 99mTc-HYNIC-PSMA
TLX599-CDx: 99mTc-HYNIC-PSMA Indication: Prostate cancer imaging, globally Innovation: • New chemistry to extend the utility of PSMA-11 to 99mTc to enable imaging of TLX599-CDx TLX591-CDx prostate cancer with gamma camera / SPECT imaging (SPECT) (PET) Rationale: • Outside of developed countries and
Slide 25: Global Clinical Leadership
Global Clinical Leadership Chair Dr. Pavel Rumiantsev Russia Dr. Ajit Shinto India Dr. Peter Tually Australia Dr. Mike Sathekge South Africa 25 Telix Pharmaceuticals Limited (ASX: TLX)
Slide 26: TLX592: 225Ac-PSMA
TLX592: 225Ac-PSMA Indication: Treatment of 177Lu-PSMA Progressive Patients Innovation: Pk-engineered • TLX591 antibody re-engineered to clear ~10x faster from the body, while maintaining antibody specificity for tumour-expressed PSMA (liver cleared, no exocrine uptake) • Harnesses Telix’s proprieta
Slide 27: TLX250-CDx: 89Zr-girentuximab Other Indications
TLX250-CDx: 89Zr-girentuximab Indication: Use in Other (Non-Renal Cancer) Indications Innovation: • TLX250-CDx targets Carbonic Anhydrase IX (CA9), a target that is highly expressed in many late-stage cancers Rationale: • Explore the utility of TLX250-CDx in other cancers where conventional imaging
Slide 28: R&D Vision: Telix will Integrate Oncology
R&D Vision: Telix will Integrate Oncology Androgen + TLX591 (PCa) – Ph III Medical Oncology / Immunology STARLITE I-O + TLX250 (RCC) – Ph II (x2) XRT + TLX101 (GBM) – Ph I / II Interventional Radiation XRT + TLX591-CDx TLX591-OR (PCa/GBM) – Ph I Oncology / Oncology (PCa) – Ph II Surgery Biology-guid
Slide 29: Closer to Home: Telix is Responsibly Re-investing Taxpayer $s
Closer to Home: Telix is Responsibly Re-investing Taxpayer $s University of Sydney Patheon / ThermoFisher Development of novel Scale-up production of Project chelators and industry- antibodies relevant radiochemistry strategies TLX250 AusHealth Clinical translation of the biologic treatment ANSTO Ap
Slide 30: Summary: R&D Impact
Summary: R&D Impact • Telix’s R&D activities are high-impact and cost-effective, harness third party funding and high-quality collaborations • Leverage both internal development capabilities and academic key opinion leaders • Pipeline / indication expansion rationally builds on existing pipeline of
Slide 31: Second Half 2020…
Second Half 2020… 31
Slide 32: Five Big Events will Define the Next Six Months
Five Big Events will Define the Next Six Months First data out from TLX101 IPAX-1 trial Market TLX591-CDx launch readiness NDA submission to US FDA TLX591-CDx Completion of ZIRCON Phase III trial Launch of Prostate program TLX591 ProstACT TLX250-CDx Kidney program Phase III trial Glioblastoma progra
Slide 33: Summary of 2020 Inflection Points
Summary of 2020 Inflection Points April – June 2020 July – September 2020 October – December 2020 Prostate cancer imaging (TLX591-CDx) Prostate cancer imaging (TLX591-CDx) Prostate cancer imaging (TLX591-CDx) ✓ European MAA submitted (April) ✓ US NDA submission imminent ✓ Commercial launch readiness
Slide 34: telixpharma.com
TELIX PHARMACEUTICALS Precision Oncology. See it. Treat it. telixpharma.com
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