Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — Investor Presentation (November 2021)
38 slides from Telix Pharmaceuticals's investor presentation, Nov 16, 2021
Slide 1: Investor Presentation
Precision Oncology See it. Treat it. Investor Presentation November 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: An established global leader in radiopharmaceuticals
An established global leader in radiopharmaceuticals Extensive portfolio of diagnostic and therapeutic assets with compelling clinical data 12,150 patient doses in past 12 months1 1st marketing authorisation ® approval for 2 TLX591-CDx (Illuccix ) received 17 active clinical trials (7 indications)3
Slide 4: Our strategy: See It. Treat it.
Our strategy: See It. Treat it. Personalised, precision medicine 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 TLX591 Therapy (Prostate cancer
Slide 5: Radiation has never been more important in cancer care
Radiation has never been more important in cancer care Underpinned by the shift from radiation “in a box” to radiation “in a shot” The evolution from external-beam From a ‘box’ To a ‘shot’ radiation to systematically-delivered and targeted radiation is transforming the role of radiation in cancer ca
Slide 6: Telix is pioneering a new cancer modality
Telix is pioneering a new cancer modality Kidney 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 (IIT) TLX250 Tx Ph Name Asset Dx/Tx II (IIT) TLX250 Tx II OPALESCENCE (IIT) TLX250-CDx Dx I Emory University (IIT) TLX591-
Slide 7: Core pipeline: Oncology & rare diseases
Core pipeline: Oncology & rare diseases Shaded arrows indicate completion expectations in the next 12 months. *Registry study 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 transport
Slide 8: Strategic Priorities
Strategic Priorities Use Illuccix as a Create a high-value Deliver on commercial Expand the commercial launchpad diagnostic portfolio value of therapeutics pipeline Establish Telix’s Kidney cancer imaging Advance late-stage assets in Novel targets, clinical leadership in the urologic agent addresses
Slide 9: Near-term objectives
Near-term objectives Unlocking the value in our pipeline 2021 2022 Illuccix commercial rollout Launch Illuccix Establish a leading presence in the urologic oncology domain Regulatory filing for kidney cancer imaging Complete ZIRCON product to follow-on Illuccix Advance late-stage therapeutic portfol
Slide 10: Illuccix Imaging: Ready to launch
Illuccix® Imaging Ready to launch Telix Pharmaceuticals Limited (ASX: TLX) 10
Slide 11: Illuccix approval and rollout milestones
Illuccix® approval and rollout milestones US FDA PDUFA1 goal date 23 December 2021 1. United States Food and Drug Administration (FDA) Prescription Drug User Fee Act, Goal Date 2. Healthcare Common Procedure Coding System Telix Pharmaceuticals Limited (ASX: TLX) 11
Slide 12: Illuccix (TLX591-CDx) PSMA-PET imaging
Illuccix (TLX591-CDx) PSMA-PET1 imaging A differentiated offering in the PSMA-PET market • Access to ~90% of eligible PET sites • On-demand pharmacy-based production with a high yield product • Customer and patient scheduling flexibility Telix / partner sites Current competitor sites (4 November 202
Slide 13: PSMA-PET imaging emerging as standard of care in prostate cancer
PSMA-PET imaging emerging as standard of care in prostate cancer Inclusion in guidelines are driving clinical adoption and reimbursement • Updated National Comprehensive Cancer Network Guidelines® include Ga-68 PSMA-11 PET/CT to be considered as an alternative to standard imaging of bone and soft ti
Slide 14: Market opportunity expanded
Market opportunity expanded Due to growing incidence rates and guideline inclusions US (NEW) 194,510 US patients with prostate cancer eligible for PSMA-PET imaging US (OLD) 146,000 57,000 1. Primary staging in newly diagnosed high-risk prostate cancer 2. Biochemical recurrence following prostatectom
Slide 15: The NOBLE Registry (TLX599-CDx): Nobody left behind
The NOBLE Registry (TLX599-CDx): Nobody left behind Improving access to PSMA imaging Chair • Collaboration to investigate utility of 99mTc-iPSMA SPECT1 imaging in prostate cancer • Global consortium of clinical sites and investigators with experience using 99mTc-iPSMA • Geographic focus on developin
Slide 16: Kidney cancer program
Kidney cancer program A clinical leadership opportunity in diagnostics and therapy Telix Pharmaceuticals Limited (ASX: TLX) 16
Slide 17: Building a high-value diagnostics portfolio
Building a high-value diagnostics portfolio “Breakthrough Therapy” designation, clinical leadership opportunity • TLX250-CDx is an investigational product being developed for the imaging of clear cell renal cell carcinoma (ccRCC) with PET/CT • Current options for patients are limited, potential for
Slide 18: ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC
ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC Study overview Eligible Patients • Single indeterminate renal mass ≤7cm Surgical removal TLX250-CDx diameter on CT or MRI suspicious for ccRCC & histology as PET/CT scan • Scheduled for surgical removal as part of standard of truth management
Slide 19: TLX250-CDx: Delivering an unmet need in kidney cancer imaging
TLX250-CDx: Delivering an unmet need in kidney cancer imaging • Total addressable market value in US and Europe estimated Yearly estimated at US$3-400M Yearly new cases, number of deaths, worldwide, both • Potential for market worldwide, both sexes, all ages leadership, given sexes, all ages limited
Slide 20: CA9 is an exciting target
CA91 is an exciting target New understanding leads to potential for applications beyond kidney cancer • A transmembrane protein and a tumor-associated carbonic anhydrase Potential Indication Status isoenzyme • Over-expressed in mutated ccRCC Bladder or Urothelial Cancer Commenced and many hypoxic so
Slide 21: STARLITE Phase II trial of TLX250 for Treatment of ccRCC
STARLITE 2 Phase II trial of TLX250 for Treatment of ccRCC TLX250 in combination with immunotherapy • Phase II trial of TLX250 plus nivolumab in with ccRCC who have progressed following prior immunotherapy • Evaluates TLX250-delivered radiation as an immune system “primer” NCT03849118 NCT03849118 ✓
Slide 22: Prostate cancer therapy
Prostate cancer therapy Our vision for prostate cancer Telix Pharmaceuticals Limited (ASX: TLX) 22
Slide 23: ProstACT program overview
ProstACT program overview Multiple opportunities to deliver insights into TLX591 Radiogenomics study • ~50 patients SELECT – radiogenomics study • First line mCRPC enhances patient selection and • Rapid recruitment supports indication expansion Treat the scan Correlation between imaging and therapy
Slide 24: ProstACT GLOBAL Ph III trial of TLX591 for the treatment of mCRPC
ProstACT GLOBAL Ph III trial of TLX591 for the treatment of mCRPC2 Study overview Eligible Patients TLX591 + Standard of care therapy • PSMA avid (defined by TLX591-CDx) v • mCRPC Standard of care therapy • Progressed despite prior therapy with NAAD alone • International, multi-centre, Phase III RCT
Slide 25: TLX591 differentiation
TLX591 differentiation Antibody vs small molecule Significantly improved overall survival in a comparable end-stage patient Efficacy population 40+ months vs. 15.3 months1,2 Reduced potential for undesirable side-effects; dry eye, xerostomia (salivary gland Patient comfort ablation), back pain (gang
Slide 26: 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 27: Our long-term vision for prostate cancer
Our long-term vision for prostate cancer Improving access, imaging and treatment options for patients • Further development of the PSMA target underpins our lifecycle management strategy for prostate cancer and vision to improve patient outcomes • PSMA pipeline includes imaging, therapy and surgical
Slide 28: 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: Radical prostatectomy non-castrate), apalutamide, Docetaxel; Sipuleucel-T; Abiraterone P
Slide 29: Rare diseases program
Rare diseases program High potential, high impact Telix Pharmaceuticals Limited (ASX: TLX) 29
Slide 30: IPAX-I Phase I/II trial of TLX101 for the treatment of GBM
IPAX-I Phase I/II trial of TLX101 for the treatment of GBM1 TLX101 in combination with EBRT2 • Multi-centre Phase I/II trial of TLX101 in combination with EBRT in patients with recurrent GBM ✓ Primary endpoint: Safety and tolerability ✓ Secondary endpoints include: MTD3, efficacy, dosimetry NCT03849
Slide 31: Follow on study IPAX-2 in planning
Follow on study IPAX-2 in planning Evaluating the potential of TLX101 in newly-diagnosed patients • Initial dose finding study TLX101 plus standard of care (SOC) in patients with newly diagnosed glioblastoma, after surgery • Evaluates the potential for “DNA damage” from targeted radiation using TLX1
Slide 32: New hope in a rare disease
New hope in a rare disease Progressing development of TLX66 in bone marrow conditioning • SALA1 is a rare disease with a poor prognosis (median survival ~11 months if untreated) • Plasma cells in the bone marrow produce abnormal protein called ‘amyloid’ which accumulates Faulty in the organs and cau
Slide 33: Future value creation
Future value creation Focus on innovation and growth markets Telix Pharmaceuticals Limited (ASX: TLX) 33
Slide 34: Near-term growth opportunities
Near-term growth opportunities Expansion into new geographic markets • China Grand Pharma partnership • NMPA consultations have commenced (Mainland China) • Regulatory filings for Illuccix Q1 2022 (Taiwan, Hong Kong) • Largest Asia Pacific market opportunity • Key bridging clinical trials have been
Slide 35: Buildout of the Brussels (Seneffe) manufacturing facility
Buildout of the Brussels (Seneffe) manufacturing facility Vertical integration in Europe • Seneffe will serve as the primary EU manufacturing site for Telix’s products ✓ Will also be used manufacture 131I-based products for export (i.e. TLX101) using Belgian-sourced isotopes NCT03849118 NCT03849118
Slide 36: Future research and innovation focus
Future research and innovation focus Targeted alpha MTR + Tumour Artificial Radio-guided therapy immuno-oncology microenvironment intelligence (AI) surgery "Next Generation" MTR sets the Combining MTR with Tools to Bringing molecular therapeutics with “groundwork” for standard of care maximise clini
Slide 37: Near-Term Catalysts
Near-Term Catalysts Calendar Q4 2021 • Illuccix EU “clock stop” for final review (end-Nov) • Illuccix US FDA decision (PDUFA goal date 23 Dec 2021) • Distributors finalised for EU product launch • First ProstACT patients • STARLITE 1/2 trials active (FDA IND approval) and recruiting Calendar Q1 2022
Slide 38: www.telixpharma.com
Precision Oncology See it. Treat it. www.telixpharma.com IR contact: Kyahn Williamson Email: kyahn.williamson@telixpharma.com
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