Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — FY2021 Earnings Presentation
33 slides from Telix Pharmaceuticals's earnings presentation, Feb 24, 2022
Slide 1: 2021 Full Year Results
2021 Full Year Results Dr Christian Behrenbruch Group CEO and Managing Director 24 February 2022 TELIX PHARMACEUTICALS LIMITED (ASX:TLX)
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: Contents
Contents 4 Highlights 2021 8 Strategic priorities and pipeline 11 Illuccix® commercial launch update 15 Clinical programs overview 25 R&D and pipeline expansion highlights 30 Outlook 3
Slide 4: An established global leader in radiopharmaceuticals
An established global leader in radiopharmaceuticals Commercial stage company with extensive pipeline of therapeutic and diagnostic assets 1st FDA approval achieved in late-20211 13,200 patient doses in the last 12 months2 18 active clinical studies, across 8 indications3 Underpinned by a secure glo
Slide 5: Highlights 2021
Highlights 2021 A year of growth and validation • Regulatory approvals for Illuccix® in the US and Australia Prostate cancer imaging • Commercial team build out complete, launch underway in Q1 2022 agent approved • First submission for US reimbursement filed Phase III kidney cancer • ZIRCON Phase II
Slide 6: Financial dashboard
Financial dashboard Well-funded to execute on next phase of growth strategy FY2021 product revenue Pro-forma cash balance FY2021 R&D investment FY2021 loss after tax $4.9M $189.0M1 $34.1M $80.5M Up 49% from Following $175M Up 48% from Up 79% from placement2 $3.3M in FY2020 $23.1M in FY2020 $44.9M in
Slide 7: Pre-approval revenue from kit sales
Pre-approval revenue from kit sales Validates clinical traction and demonstrates commercial scale • Continued growth in kit sales under pre-approval TLX591-CDx Kit Sales 2020 vs 2021 regulations during 2021 1,600 • Growing user base with 5,266 kits sold (investigational, 1,400 1,528 clinical trial,
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 Novel targets, clinical leadership in urologic agent addresses major
Slide 9: Focus for 2022
Focus for 2022 Unlocking the value in our pipeline • US reimbursement Illuccix global rollout • Additional global approvals anticipated (EU/UK, Canada) • Commercial launch (US and AU) • Kidney cancer (TLX250-CDx) Phase III readout Commercialise diagnostics • Prepare for US regulatory filing for TLX2
Slide 10: Core pipeline: oncology & rare diseases
Core pipeline: oncology & rare diseases Targeting Target Radioactive Phase I Phase II Phase III Commercial Molecule Isotope Small molecule PSMA1 68Ga TLX591-CDx (68Ga-PSMA-11, Illuccix®) Imaging Antibody PSMA 177Lu TLX591 (177Lu–rosopatamab) Therapy Prostate Antibody PSMA 225Ac TLX592 (225Ac–RADmAb®
Slide 11: Illuccix® commercial launch update
Illuccix® commercial launch update 11
Slide 12: Illuccix US commercial launch timeline
Illuccix US commercial launch timeline ® Website and reader training Contracting of Anticipated launched additional HCPCS code (mid-Feb) pharmacies to (1 Apr) commence FDA Approval HCPCS1 ASCO-GU 2022 (20 Dec) Reimbursement (22 Feb) Pass through Application AUA status anticipated (4 Jan) (16 May) (1
Slide 13: Broad US market coverage
Broad US market coverage Flexibility and access a key differentiator • Access to ~>85% eligible PET sites via distribution partners Cardinal Health and Pharmalogic and direct sales team in the first “wave” of pharmacy sites • Distribution network holds 60% market share of nuclear medicine market in
Slide 14: Illuccix US pricing structure
Illuccix US pricing structure ® • Expected to be published 1 March 2021 and in line with prior expectation (between USD $4,000 and $5,000 per dose) • 5 mCi is expected to be the common dose size based on proven efficacy and safety • Prescribing information allows for a dose range of 3 to 7 mCi, allo
Slide 15: Clinical programs overview
Clinical programs overview 15
Slide 16: Prostate cancer therapy PSMA program
Prostate cancer therapy PSMA program Target: Prostate Specific Membrane Antigen (PSMA) Lead therapy program: Next-generation alpha TLX591 (177Lu-rosopatamab) therapy program: TLX592 (225Ac-RADmAb®) Targeting molecule: Antibody Targeting molecule: Development status: Engineered antibody • ProstACT GL
Slide 17: TLX591: A differentiated approach to PSMA therapy
TLX591: A differentiated approach to PSMA therapy Antibody-based PSMA program, with potential to offer treatment options across the disease spectrum • More efficient delivery of radiation compared to small molecule, enabling shorter, patient-friendly dosing, and potential for improved efficacy and q
Slide 18: TLX592: Next-generation targeted alpha therapy
TLX592: Next-generation targeted alpha therapy Engineered Normal Complementary to TLX591 beta therapy Antibody Antibody TLX592 TLX591 Radiation • Alpha emitters are highly targeted, high-energy radionuclides with a cleared from localised radiation profile – potentially more potent and less likely to
Slide 19: Kidney cancer / CA9 program
Kidney cancer / CA9 program Target: Carbonic Anhydrase IX (CAIX / CA9) Lead imaging candidate: Lead therapy candidate: TLX250-CDx (89Zr-girentuximab) TLX250 (177Lu-girentuximab) Targeting molecule: Antibody Targeting molecule: Antibody Development status: Development status: • ZIRCON Phase III study
Slide 20: TLX250: Harnessing MTR as an immune primer
TLX250: Harnessing MTR1 as an “immune primer” Potential to “bolt on” to the $100B2 immunotherapy market CA9 is over-expressed in many solid tumours and in patients who are likely to demonstrate a more limited response to cancer immunotherapy • CA9 is upregulated in over 95% of ccRCC cases and in man
Slide 21: Brain cancer / LAT-1 program
Brain cancer / LAT-1 program Target: Large amino acid transporter 1 (LAT-1) Lead imaging program: Lead therapy program: TLX101-CDx (18F-FET) TLX101 (131I-IPA) Targeting molecule: Small molecule Targeting molecule: Small molecule Development status: Development status: • Preparing New Drug Applicatio
Slide 22: Imaging key to managing an aggressive cancer
Imaging key to managing an aggressive cancer Advancing towards US regulatory filing Brain cancer imaging expected to be Telix’s third commercial imaging product • Glioblastoma (GBM) is the most common primary brain cancer in adults, approximately 50% of brain tumours • Imaging plays a key role in di
Slide 23: Building on the IPAX-1 experience
Building on the IPAX-1 experience Promising data warrants investigation in a front-line setting • IPAX-1 multi-centre Phase I trial of TLX101 in combination with external beam radiation therapy (EBRT) in patients with recurrent GBM completed in 2021 • Promising survival data: interim analysis showed
Slide 24: Bone marrow conditioning / CD66
Bone marrow conditioning / CD66 Target: CD66 (Cluster of differentiation 66) Lead imaging program: Lead therapy program: TLX66-CDx (99mTc-besilesomab) TLX66 (90Y-besilesomab) Scintimun® for scintigraphic Bone marrow conditioning for systemic bone imaging amyloid light chain amyloidosis Targeting mol
Slide 25: R&D and pipeline expansion highlights
R&D and pipeline expansion highlights 25
Slide 26: 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 27: Pan-cancer collaboration with Merck
Pan-cancer collaboration with Merck Progressing to clinical trials • Investigating Merck KGaA, Darmstadt, Germany (Merck), DNA Damage Response Inhibitor (DDRi) molecules in combination with each of TLX591 and TLX2501 • Builds on the success of a pre-clinical research collaboration, now progressing t
Slide 28: Radioguided surgery aids real-time detection of cancer
Radioguided surgery aids real-time detection of cancer A potential new clinical application taking MTR into the operating room • Precision-guided cancer surgery, a fast-growing market, estimated to be worth US$3B • Lightpoint’s SENSEI® is the world’s first approved • Molecularly targeted imaging age
Slide 29: Understanding the tumour microenvironment (TME)
Understanding the tumour microenvironment (TME) A new approach to treat “difficult” tumours In-licenced antibody: APOMAB-directed MTR integrates into many oncology therapeutic regimens1 • Cancer biology, expression of biomarkers and tumour aggressiveness are the result of the • Novel antibody target
Slide 30: Outlook
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Slide 31: Telix is pioneering a new cancer modality
Telix is pioneering a new cancer modality Glioblastoma Kidney Cancer Ph Name Asset Dx/Tx Ph Name Asset Dx/Tx I/II TLX101 Tx III TLX250-CDx Dx 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 32: Upcoming catalysts
Upcoming catalysts Q1 2022 Q2 2022 2H 2022 ProstACT TARGET ethics HCPCS code granted Full reimbursement status in US approval for Illuccix STARLITE 2 study patient IPAX-2 (brain cancer) study ZIRCON study data readout dosing to commence ZIRCON study 252 patients First commercial sales US / ProstACT
Slide 33: Thank you and questions
Thank you and questions Investor relations contact: Kyahn.williamson@telixpharma.com TELIX PHARMACEUTICALS LTD (ASX:TLX)