Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — Investor Presentation (January 2022)
62 slides from Telix Pharmaceuticals's investor presentation, Jan 24, 2022
Slide 1: Precision Oncology: See it. Treat it. Capital raise presentation
For personal use only Precision Oncology See it. Treat it. Capital raise presentation January 2022 Not for release on U.S. wire services or distribution in the United States
Slide 2: Important notice and disclaimer
Important notice and disclaimer For personal use only This Presentation contains summary information about Telix Pharmaceuticals Limited ACN 616 620 369 (Telix or Disclaimer (cntd) the Company) and its activities as at 24 January 2022] The information in this Presentation is of a general nature No p
Slide 3: Contents
Contents For personal use only Executive summary 4 Offer details 9 Company and programs overview 13 • Illuccix® imaging 21 • Prostate cancer therapy 27 • Renal cancer program 38 • Rare diseases program 45 • Future value creation 51 Key risks 55 International selling restrictions 58 Telix Pharmaceuti
Slide 4: Executive summary
Executive summary For personal use only • US FDA approval received December 2021 First commercial product • Commercial launch ready in US and AU from late Q1, 2022 now approved in the US • Additional global approvals expected in EU/UK and Canada • Use Illuccix as a commercial launchpad Clear growth
Slide 5: Financial snapshot
Financial snapshot ASX: TLX For personal use only Market information (as of 19 January 2022) Share price (12 months to 19 January 2022) AUD Share price $8.09 9.00 Market capitalisation ~$2.45B 8.00 Shares on issue 285M Options on issue ~18M 7.00 Cash balance as of 31 December 2021 $22M 6.00 Top 5 sh
Slide 6: Strategic priorities
Strategic priorities For personal use only 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 urolo
Slide 7: Focus for 2022
Focus for 2022 Unlocking the value in our pipeline For personal use only • US reimbursement Illuccix global rollout • Additional global approvals including EU/UK, Canada • Commercial launch from late Q1 2022 (US and AU) • Kidney cancer (TLX250-CDx) Phase III readout Commercialise diagnostics • Prepa
Slide 8: Recent milestones and near-term catalysts
Recent milestones and near-term catalysts For personal use only Recently completed milestones Upcoming milestones: Q1 2022 • Illuccix regulatory approvals granted in US • Illuccix commercial launch US and AU and Australia • US reimbursement for Illuccix: • HCPCS1 reimbursement submitted for Illuccix
Slide 9: Offer Details
For personal use only Precision Oncology See it. Treat it. Offer Details Placement and Share Purchase Plan 9
Slide 10: Offer details
Offer details Placement and Share Purchase Plan to raise $200M For personal use only • Telix is conducting the Offer to raise $200 million, comprising: • an institutional placement to raise $175 million (Placement); and Offer Structure • a Share Purchase Plan to raise up to $25 million (SPP). and Si
Slide 11: Source and use of funds
Source and use of funds Advancing and expanding the therapeutic (Tx) and diagnostic (Dx) portfolio For personal use only • Complete ProstACT prostate cancer therapy studies Source of Funds A$m (TLX591) including ProstACT GLOBAL Phase III study Placement 175 • Complete STARLITE 1 & 2 – Phase II studi
Slide 12: Offer timetable
Offer timetable Placement and Share Purchase Plan timetable For personal use only Event Date (AEDT)* Trading halt Thursday, 20 January 2022 Record date for SPP 7.00pm Friday, 21 January 2022 Announcement of the Placement and SPP, trading halt lifted Monday, 24 January 2022 Settlement of the Placemen
Slide 13: Company and programs overview
For personal use only Precision Oncology See it. Treat it. Company and programs overview Our commercial and core clinical programs 13
Slide 14: Company overview
Company overview An established global leader in radiopharmaceuticals For personal use only Extensive portfolio of diagnostic and therapeutic assets with compelling clinical data 12,150 patient doses in past 12 months1 FDA approval for TLX591-CDx (Illuccix®)2 18 active clinical studies (8 indication
Slide 15: Board of Directors
Board of Directors Kevin McCann Christian Behrenbruch For personal use only Independent, Non-Executive Director and Chairman Group CEO and Managing Director Mr McCann has extensive Board experience with some of Australia’s most Dr Behrenbruch has over 20 years of healthcare entrepreneurship and reco
Slide 16: Global Leadership Team
Global Leadership Team For personal use only Gabriel Liberatore Douglas Cubbin Colin Hayward Group Chief Operating Officer Group Chief Financial Officer Group Chief Medical Officer David Cade Jonathan Barlow Richard Valeix CEO, Asia Pacific Chief Business Development Officer CEO, EMEA & General Coun
Slide 17: Our strategy: See It. Treat it.
Our strategy: See It. Treat it. Personalised, precision medicine For personal use only Targeted radiation delivery Systemically administered Imaging PET1 scanner TLX591-CDx2 (Prostate cancer) Unique cancer cell signature (target) 68Ga, 89Zr (diagnostic isotopes) Enables PET images of cancer TLX591 T
Slide 18: 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” For personal use only The evolution from external-beam radiation to From a ‘box’ To a ‘shot’ systematically-delivered and targeted radiation is transforming the role of
Slide 19: Telix is pioneering a new cancer modality
Telix is pioneering a new cancer modality Kidney Cancer Glioblastoma For personal use only 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 Un
Slide 20: Core pipeline: oncology & rare diseases
Core pipeline: oncology & rare diseases For personal use only Shaded arrows indicate completion expectations in the next 12 months. *Registry Study 1. Prostate-specific membrane antigen. 3. Large amino acid transporter 1. 5. Cluster of differentiation 66. 2. Carbonic anhydrase IX. 4. Bone marrow con
Slide 21: Illuccix imaging
For personal use only Illuccix® imaging Launching in Q1 2022 Telix Pharmaceuticals Limited (ASX: TLX) 21
Slide 22: Illuccix is now approved in the United States
Illuccix® is now approved in the United States Indication and usage information For personal use only Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-s
Slide 23: Market opportunity for prostate imaging is expanding
Market opportunity for prostate imaging is expanding Due to growing incidence rates and practice guidelines For personal use only US PATIENTS Potential clinical utilisation: (REVISED) US PATIENTS 194,5101 1. Primary staging in newly diagnosed high-risk prostate cancer (NCCN) (PRIOR) 146,000 (1) 57,0
Slide 24: Commercial launch plans - US
Commercial launch plans - US Commercial ramp up during Q1 2022 For personal use only Positioned to capture meaningful market share • Access to ~90% of eligible PET sites • Distribution network holds 60% market share of nuclear medicine market in the US • On-demand pharmacy-based production with a hi
Slide 25: 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 is driving clinical adoption and reimbursement For personal use only • National Comprehensive Cancer Network Guidelines® (NCCN Guidelines) include Ga-68 PSMA-11 PET/CT to be considered as an alternative to stand
Slide 26: The NOBLE Registry (TLX599-CDx): Nobody left behind
The NOBLE Registry (TLX599-CDx): Nobody left behind Improving access to PSMA imaging – beyond Illuccix For personal use only Chair • Collaboration to investigate utility of 99mTc-iPSMA SPECT1 imaging in prostate cancer • Global consortium of clinical sites and investigators with experience using 99m
Slide 27: Prostate cancer therapy
For personal use only Prostate cancer therapy Our vision for prostate cancer Telix Pharmaceuticals Limited (ASX: TLX) 27
Slide 28: Prostate cancer therapy assets overview
Prostate cancer therapy assets overview Next-generation therapy to follow TLX591 For personal use only • Target: Prostate Specific Membrane Antigen (PSMA) Target: PSMA TLX591 TLX592 • Indication: Prostate cancer • Clinical status: • TLX591: ProstACT GLOBAL Phase III + ancillary studies Targeting Eng
Slide 29: ProstACT program overview
ProstACT program overview Multiple opportunities to deliver insights into TLX591 For personal use only Radiogenomics study • ~50 patients SELECT (Ph I) – radiogenomics • 1st line metastatic study enhances patient selection prostate cancer (mCRPC) and supports indication expansion Treat the scan • Ra
Slide 30: ProstACT GLOBAL Phase III study
ProstACT GLOBAL Phase III study Pivotal trial For personal use only TLX591 + Standard of Care (SoC) vs. SoC alone Eligible Patients TLX591 + Standard of care therapy • PSMA avid (defined by TLX591-CDx) • mCRPC1 Standard of care therapy • Progressed despite prior therapy with NAAD2 alone • Internati
Slide 31: ProstACT SELECT Phase I study
ProstACT SELECT Phase I study Enhances patient selection and supports indication expansion For personal use only Treat the scan Correlation between imaging and therapy to optimise patient selection Eligible Patients TLX591 + Standard of care therapy • PSMA avid (defined by TLX591-CDx) Comparative im
Slide 32: ProstACT TARGET Phase II study
ProstACT TARGET Phase II study Expanding clinical data to include a front-line setting For personal use only Early data in front line care In partnership with: Efficacy data in patients in their first recurrence Eligible Patients TLX591 + External Beam • PSMA avid (defined by TLX591-CDx) Radiation T
Slide 33: TLX591 differentiation
TLX591 differentiation Potential advantages with PSMA antibody approach For personal use only Potential for improved overall survival (OS) in advanced metastatic disease, with Efficacy 40+ months OS reported to date1 Reduced potential for off-target side-effects: dry eye, xerostomia (salivary gland
Slide 34: TLX591 patient experience
TLX591 patient experience Off-target irradiation – quality of life matters For personal use only 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 endog
Slide 35: Our long-term vision for prostate cancer
Our long-term vision for prostate cancer Improving access, imaging and treatment options for patients For personal use only • Further development of the PSMA target underpins our lifecycle management strategy for prostate cancer and vision to improve patient outcomes • PSMA pipeline includes imaging
Slide 36: Our clinical mission: support the patient every step of the way
Our clinical mission: support the patient every step of the way For personal use only Localised disease Advancing clinical stages Metastatic castrate resistant Radiation therapy +/- ADT Docetaxel, abiraterone (metastatic, First line: Radical prostatectomy non-castrate), apalutamide, Docetaxel; Sipul
Slide 37: CUPID trial
CUPID trial Next-generation alpha therapy, complements TLX591 For personal use only Study with 64Cu-TLX592 to show biodistribution and tumour targeting prior to targeted alpha therapy (TAT) with 225Ac-TLX592 Eligible Patients 225Ac-TLX592 64Cu-TLX592 • Prostate cancer patients with low-burden TAT me
Slide 38: Renal cancer program
For personal use only Renal cancer program A clinical leadership opportunity in diagnostics and therapy Telix Pharmaceuticals Limited (ASX: TLX) 38
Slide 39: TLX250-CDx / TLX250 overview
TLX250-CDx / TLX250 overview An exciting target, with potential application beyond kidney cancer For personal use only • Target: Carbonic Anhydrase IX (CAIX / CA9) Target: Dx Tx • Indication: Kidney cancer (clear cell renal cell carcinoma, ccRCC) CAIX / CA9 (TLX250-CDx) (TLX250) • Development status
Slide 40: Building a high-value diagnostics portfolio
Building a high-value diagnostics portfolio “Breakthrough Therapy” designation, clinical leadership opportunity For personal use only • Biologics License Application (BLA) consultation process has commenced, Phase III study in final stages of enrolment • TLX250-CDx is an investigational product bein
Slide 41: TLX250-CDx: delivering an unmet need in kidney cancer imaging
TLX250-CDx: delivering an unmet need in kidney cancer imaging For personal use only • Total addressable market value in US and Europe estimated Yearly estimated at US$300-400M1 Yearly new cases, number of deaths, worldwide, both • Potential for market worldwide, both sexes, all ages leadership, give
Slide 42: ZIRCON Phase III trial of TLX250-CDx
ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC Study overview For personal use only Eligible Patients • Single indeterminate renal mass ≤7cm Surgical removal TLX250-CDx diameter on CT or MRI suspicious for ccRCC and histology as PET/CT scan • Scheduled for surgical removal as part of stan
Slide 43: STARLITE Phase II trial of TLX250
STARLITE 2 Phase II trial of TLX250 for treatment of ccRCC TLX250 in combination with immunotherapy For personal use only • STARLITE 2 now actively recruiting (screening patients) • Phase II trial of TLX250 plus nivolumab with ccRCC who have progressed following prior immunotherapy •NCT03849118 Eval
Slide 44: CA9 indication expansion
CA9 indication expansion New understanding leads to potential for applications beyond kidney cancer For personal use only • A transmembrane protein and a tumor-associated carbonic anhydrase Potential Indication Status isoenzyme • Over-expressed in mutated ccRCC Bladder or Urothelial Cancer Commenced
Slide 45: Rare diseases program
For personal use only Rare diseases program High potential, high impact Telix Pharmaceuticals Limited (ASX: TLX) 45
Slide 46: TLX101-CDx / TLX101 overview
TLX101-CDx / TLX101 overview Orphan designation status granted for imaging and therapy candidates For personal use only • Target: Large amino acid transporter 1 (LAT-1) Dx Tx • Indication: Glioblastoma multiforme (GBM) Target: LAT-1 (TLX101- (TLX101) CDx) • Clinical status: • TLX101-CDx: Progressing
Slide 47: IPAX-I Phase I/II trial of TLX101 for GBM
IPAX-I Phase I/II trial of TLX101 for the treatment of GBM1 TLX101 in combination with EBRT2 For personal use only • 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, effica
Slide 48: Building on the IPAX-1 experience
Building on the IPAX-1 experience IPAX-2 will evaluate TLX101 in newly-diagnosed patients For personal use only • Progression of TLX101 program into front-line setting, Phase I/II study expected to commence in Q1 2022 • Initial dose finding study TLX101 plus standard of care (SOC) in patients with n
Slide 49: TLX66 CDx / TLX66 overview
TLX66 CDx / TLX66 overview Application across a range of conditions requiring bone marrow conditioning For personal use only • Target: CD66 (Cluster of differentiation 66) Dx Tx • Indication: Target: CD66 (TLX66- (TLX66) CDx) • TLX66-CDx: Scintigraphic bone imaging • TLX66: Bone marrow conditioning
Slide 50: New hope in a rare disease
New hope in a rare disease Progressing development of TLX66 in bone marrow conditioning For personal use only • 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
Slide 51: Future value creation
For personal use only Future value creation Focus on innovation and growth markets Telix Pharmaceuticals Limited (ASX: TLX) 51
Slide 52: Near-term growth opportunities
Near-term growth opportunities Expansion into new geographic markets For personal use only • 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 clin
Slide 53: Buildout of the Brussels (Seneffe) manufacturing facility
Buildout of the Brussels (Seneffe) manufacturing facility Vertical integration in Europe For personal use only • Seneffe will serve as the primary EU manufacturing site for Telix’s products • Will also be used to manufacture 131I-based products for export NCT03849118 (i.e. TLX101) using Belgian-sour
Slide 54: Future research and innovation focus
Future research and innovation focus For personal use only Targeted alpha MTR1 + 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
Slide 55: Key risks
For personal use only Key risks Telix Pharmaceuticals Limited (ASX: TLX) 55
Slide 56: Key risks
Key risks • Pricing: There is no guarantee that the Company’s products will obtain anticipated selling prices or reimbursement levels, which may impact profitability and For personal use only marketability of the products. • Competition: Telix’s industry is highly competitive. Many competitors have
Slide 57: Key risks
Key risks • Quality Assurance: Telix operates in a complex, highly regulated environment relating to the manufacture and supply of medical treatments for humans. Telix For personal use only has implemented a Quality Management System (QMS) which is paramount to ensuring patient safety, however, for
Slide 58: International offer restrictions
For personal use only International offer restrictions Telix Pharmaceuticals Limited (ASX: TLX) 58
Slide 59: International offer restrictions (1/3)
International offer restrictions (1/3) For personal use only This document does not constitute an offer of Shares of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the Shares may not be offered or sold, in any cou
Slide 60: International offer restrictions (2/3)
International offer restrictions (2/3) For personal use only Hong Kong (cntd) No advertisement, invitation or document relating to the Shares has been or will be issued, or has been or will be in the possession of any person for the purpose of issue, in Hong Kong or elsewhere that is directed at, or
Slide 61: International offer restrictions (3/3)
International offer restrictions (3/3) For personal use only Switzerland The Shares may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange or on any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering or
Slide 62: Precision Oncology: See it. Treat it.
For personal use only Precision Oncology See it. Treat it. www.telixpharma.com IR contact: Kyahn Williamson Email: kyahn.williamson@telixpharma.com
Telix Pharmaceuticals — Investor Presentation (January 2022) on 6ix