Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — Investor Presentation (July 2019)
32 slides from Telix Pharmaceuticals's investor presentation, Jul 17, 2019
Slide 1: Telix Pharmaceuticals Limited Precision Oncology Placement Presentation
Telix Pharmaceuticals Limited Precision Oncology Placement Presentation 17 July 2019
Slide 2: Important Notice & Disclaimer
Important Notice & Disclaimer This Presentation contains summary information about Telix Pharmaceuticals Limited ACN 616 620 369 Investment risk (Telix or the Company) and its activities as 17 July 2019. The information in this Presentation is of a An investment in Telix shares is subject to investm
Slide 3: Investment Highlights
Investment Highlights • Advanced pipeline addresses clear unmet medical need in high-value oncology segments: renal cancer, prostate cancer and glioblastoma ü Both diagnostic and therapeutic potential ü Two late-stage Phase III product candidates ü De-risked clinical pipeline with extensive patient
Slide 4: Company Overview
Company Overview • Telix is a late-stage biotech developing an advanced pipeline of molecularly-targeted radiation (MTR) products • Clear unmet medical needs in high-value oncology segments, multi $Bn market opportunity Indication Diagnostic Therapeutic Metastatic prostate cancer Commercial Phase II
Slide 5: Financial Snapshot
Financial Snapshot $1.67 (12 July 2019) Mkt. Cap: ~A$365m (USD ~$256m) Disease Focus Oncology Clinical Stage Phase I - III Shares on Issue 218.4m Options on Issue 17.7m IPO Price: $0.65 Cash on Hand ~AUD $20m ASX Ticker TLX • Nov 2017 – IPO on the Australian Securities Exchange (ASX). Raised AUD $50
Slide 6: Clinical Pipeline
Clinical Pipeline Isotope Target Agent Phase I Phase II Phase III Commercial 177Lu CA-IX Antibody TLX250 (Girentuximab) Therapy Renal 89Zr CA-IX Antibody TLX250-Cdx (Girentuximab) Imaging Prostate 177Lu PSMA Antibody TLX591 TLX591 Therapy Small 68Ga PSMA TLX591-Cdx (PSMA-11) Imaging Molecule Small 1
Slide 7: Telix's Pipeline is a Multi-$Bn Opportunity
Telix’s Pipeline is a Multi-$Bn Opportunity* TLX101: The treatment of GBM is TLX591: Metastatic prostate cancer a $300m market opportunity with radionuclide therapy is a $2Bn few beneficial options for patients opportunity in late-stage disease alone TLX250-CDx: Renal cancer patients are often mis-s
Slide 8: Our Approach: Molecularly-Targeted Radiation (MTR)
Our Approach: Molecularly-Targeted Radiation (MTR) MTR works by chemically “linking” radioactive isotopes to targeting molecules specific to cancer cells We distinguish the term MTR because there are many “radiopharmaceuticals” that are not targeted. Telix is targeting agent agnostic – we use both a
Slide 9: See it, Treat it…
Positron Emission Tomography – “PET” See it, Treat it… • Telix develops drugs that deliver targeted radiation directly to cancer cells. At low doses (with diagnostic radionuclides), the patient can be imaged The use of molecular imaging with PET enables a precision medicine approach to treatment thr
Slide 10: Why is MTR so Therapeutically Effective?
Why is MTR so Therapeutically Effective? CONVENTIONAL TARGETED MOLECULARLY TARGETED RADIATION Non-Radioactive Drugs MTR Therapy 10
Slide 11: TLX591-CDx (Prostate Ca Imaging)
§ PSMA11 is the most widely used TLX591-CDx (Prostate Ca Imaging) PSMA prostate cancer agent § In 150+ publications, PSMA11 68Ga-HBED- Prostate-Specific demonstrated excellent detection of Membrane prostate cancer from high-risk pre- CC-PSMA11 Antigen (PSMA) prostatectomy patients to BCR and metasta
Slide 12: Early TLX591-CDx Adoption is Growing
Early TLX591-CDx Adoption is Growing 3 ü >100 sites around the world use the product routinely or 49 5 in clinical trials ü Mostly large cancer centres that are capable of doing 3 10-15 patients a week 8 55 (upon product approval) 2 8 1 1 ü On track to deliver between 7 3 10,000 and 15,000 kits in 1
Slide 13: TLX591 (Prostate Ca Therapy)
Retrospective cross-trial comparison between TLX591 (Prostate Ca Therapy) 177 Lu-PSMA-617 and 177 Lu-huJ591 (TLX591) Median overall survival (OS) is >40 177Lu-DOTA- Prostate-Specific months (hu591) vs 15 months Membrane huJ591 Antigen (PSMA) 6 Ph I/II trials Phase III >200 patients Data published: T
Slide 14: TLX250-CDx (Renal Ca Imaging)
TLX250-CDx (Renal Ca Imaging) Benign 89Zr-DFO- Carbonic Anhydrase IX girentuximab (CAIX) Malignant >300 patients Phase III ccRCC imaged with 124I, 89Zr (Confirmatory) § Prior Ph III trial with 124I NCT03849118 § ZIRDOSE 124I to 89Zr bridging § 252 patient global phase III study, recruiting study com
Slide 15: TLX250 (Renal Ca Therapy)
TLX250 (Renal Ca Therapy) § Average tumor increase (RECIST) in 177Lu-DOTA- Carbonic the 3 months prior to Anhydrase IX treatment was 40.4% girentuximab (CAIX) § In the 3 months after 37 patients treatment it was 5.5% with 177Lu, Phase II ~900 for mAb § >10 months PFS in heavily pre-treated STARLITE
Slide 16: TLX101 (Glioblastoma Therapy)
Image-based evaluations with MRI and PET are invaluable for measuring treatment TLX101 (Glioblastoma Therapy) response in GBM patients Case Study: LAT-1 131I-IPA • Treatment: 2GBq TLX101 single dose I.V. (Large Amino Acid Baseline F/U month 4 • Safety: no acute, sub-acute or delayed Transporter) tox
Slide 17: Multiple Milestones and Readouts in 2019
Multiple Milestones and Readouts in 2019 Q1 Q2 Q3 Q4 US/JP2 Pre-INDs US/JP2 INDs Filed Enrolment Complete Imaging Cancer Renal (Phase III) Therapy (Phase I/II) Mfg completed US IND Filed Info Package to FDA Pre-NDA meeting NDA Go/No Go Prostate Cancer Imaging NDA1 (US) TLX591 Therapy (Phase III) Inf
Slide 18: Global Supply Chain and Distribution Network
Global Supply Chain and Distribution Network ü Multiple commercial partnerships with leading global healthcare companies ü For clinical trials and early commercial product roll-out Backup Ba cku p 18
Slide 19: Expected Near-Term Catalysts
Expected Near-Term Catalysts ü July: Report outcome on pre-Phase III IND meeting with FDA that took place on 17th of June for ZIRCON Phase III study (renal cancer imaging) ü July: Outcome of Japanese PMDA submission for renal cancer imaging (Phase II – to bridge to global Phase III study) ü July/Aug
Slide 20: Offer Details
Offer Details 20
Slide 21: Rationale for Capital Raise
Rationale for Capital Raise • A clear post-Phase III roadmap from the FDA for TLX250-CDx (renal cancer imaging) means the investment in manufacturing scale-up is warranted • Significant acceleration of both prostate therapeutic and imaging programs means an accelerated need for capital in 2020 • Pot
Slide 22: Placement Details and Issued Capital
Placement Details and Issued Capital The Placement Placement Price per Share1 A$1.30 Total number of shares to be issued offered under the Placement2 30.77 million Proceeds from the Placement A$40.0 million Issued capital (Fully Paid Ordinary Shares) Number Open 218,365,836 Placement Shares 30,770,0
Slide 23: Shareholdings: Founders and Board of Directors
Shareholdings: Founders and Board of Directors At Placement Date On Completion of Placement Number % Number % Dr. Christian Behrenbruch* 24,675,000 11.3 24,675,000 9.9 Dr. Andreas Kluge* 24,675,000 11.3 24,675,000 9.9 Board of Directors 3,556,250 1.6 3,556,250 1.4 Other existing shareholders 165,459
Slide 24: Use of Placement Proceeds – AUD $40m
Use of Placement Proceeds – AUD $40m $28.0m 24
Slide 25: Key Risks
Key Risks Commercial • Pricing: There is no guarantee that the Company’s products will obtain anticipated selling prices or reimbursement levels, which will impact profitability and marketability of the products • Competition: Telix’s industry is highly competitive and many competitors have greater
Slide 26: Target Inflection Points: 2020
Target Inflection Points: 2020 ‘101’s orphan status means a successful Ph II will support a Second product rapid Ph IIII submitted for marketing First significant $ approval from approved product sales COMPLETE INITITATE APPROVAL SUBMISSION COMPLETE Enrolment for TLX591 Ph III (US) TLX591-CDx TLX250
Slide 27: Management Team Biographies
Management Team Biographies 27
Slide 28: Board of Directors
Board of Directors Mr. H. Kevin McCann AM Ms. Jann Skinner Chairman Non-executive Director Kevin is Chairman of Citadel Group Limited (ASX: CGL) and China Matters. Jann has extensive experience in audit and accounting and in the insurance industry. She He is a Pro Chancellor of the University of Syd
Slide 29: Management Team
Management Team Dr. Rosalind Wilson (Interim Chief Medical Officer) Dr. Christian Behrenbruch (Co-Founder, MD and CEO) Ros is a graduate of Monash Medical School and also holds an MBA from London Chris has 20 years of healthcare executive experience as CEO, Mirada Solutions, CTI Business School. Aft
Slide 30: International Operations
International Operations Dr. Shintaro Nishimura (President, Telix Japan) Shintaro is a highly-experienced drug development and commercialization professional, with particular emphasis on the use of molecular imaging in drug development. Prior to Telix, Shintaro held senior positions at Eli Lilly, Im
Slide 31: International Scientific Advisory Board
International Scientific Advisory Board Dr. Rodney Hicks Dr. Neil Bander Chair of Urology at Weill Cornell Medical Centre (NY, USA). First led the Chief of Nuclear Medicine and Radiology, Peter MacCallum Cancer Centre development of PSMA-targeting radiopharmaceuticals for prostate (Melbourne, Austra
Slide 32: www.telixpharma.com
www.telixpharma.com a) TELIX
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