Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — H1 2022 Earnings Presentation
33 slides from Telix Pharmaceuticals's earnings presentation, Aug 18, 2022
Slide 1: 1H 2022 Financial Results Presentation
1H 2022 Financial Results Presentation Telix Pharmaceuticals Limited 18 August 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 implied,
Slide 3: Today's presenters
Today’s presenters Kyahn Williamson Dr Christian Behrenbruch Darren Smith Dr Colin Hayward SVP INVESTOR GROUP CEO AND GROUP CHIEF GROUP CHIEF R E L AT I O N S & MANAGING DIRECTOR FINANCIAL OFFICER MEDICAL OFFICER C O R P O R AT E C O M M U N I C AT I O N 3
Slide 4: Agenda
Agenda • 1H 2022 milestones • Commercial update • 1H 2022 financial results overview • Clinical programs update • Pipeline expansion highlights • Outlook 4
Slide 5: Major milestones delivered in 1H 2022
Major milestones delivered in 1H 2022 We are delivering to our strategic priorities • U.S. launch off to a strong start, additional global approvals expected Use Illuccix as a commercial launchpad • IND1 filed for Phase III bridging study in China • ZIRCON Phase III trial completed, indication expan
Slide 6: Financial dashboard
Financial dashboard Key financial metrics underpin commercial transition 1H 2022 Revenue1 Cash balance 1H 2022 R&D investment 1H 2022 loss after tax $24.0M $122.6M $24.8M $70.9M Up 726% from Closing cash balance as at 31 Up 82% from Up 118% from $2.9M in 1H 2021 December 2021 was $22.0M $13.7M in 1H
Slide 7: Commercial update
—- Commercial — ~ update ser co Vial
Slide 8: Reimbursement driving sales ramp-up
Reimbursement driving sales ramp-up Growing user base in both major metropolitan and regional markets • First commercial dose DOSES U.S. SALES REVENUE delivered on 14 April 20221 DELIVERED ILLUCCIX (US$M) IN 43 • Reimbursement driving sales S TAT E S growth, up 25% month on month in July2 • Strong s
Slide 9: 68Ga-PSMA-11 positron emission tomography (PET)
68Ga-PSMA-11 positron emission tomography (PET) Current and potential uses in clinical practice P R I M A RY S TA G I N G BIOCHEMICAL RECURRENCE RESPONSE ASSESSMENT1 68Ga-PSMA-11 Bone scan Baseline After therapy 1. Illuccix is not currently indicated to monitor for response to therapy. 2. Reproduced
Slide 10: Rapidly scalable distribution model
Rapidly scalable distribution model The gallium production method follows the technetium experience ILLUCCIX NETWORK COVERAGE • The gallium generator / radiopharmacy model is rapidly scalable and follows the traditional “nuclear medicine” model used in 99mTc (technetium) imaging procedures U.S. annu
Slide 11: The field of PSMA imaging and therapy is evolving
The field of PSMA imaging and therapy is evolving Our ability to deliver globally is a key advantage PSMA imaging has the potential TELIX PSMA-PET / to shape patient-management SPECT IMAGING strategies: GLOBAL ROLLOUT Defining new disease states Marketing authorisation received in U.S. and Austral
Slide 12: 1H 2022 financial results overview
1H 2022 financial results overview 12
Slide 13: Strong momentum from U.S. commercial launch
Strong momentum from U.S. commercial launch Maiden commercial sales drive revenue increase • Worldwide revenue of $24.0 million, up from $2.9 million in 1H 2021 PRODUCT REVENUE (AUD$M) • Product revenue $22.5 million – includes $19.3 25.0 22.5 million (US$13.5 million) of Illuccix U.S. sales • Resea
Slide 14: Cash flow
Cash flow Impact of commercial sales will be evident from 2H 2022 • Cash receipts (from product sales) $7.3 million CASH RECEIPTS FREE CASH FLOW (1H 2022) up from $1.8 million in 1H 2021 (OUTFLOW) (AUD$M) • Cash receipts from first quarter of U.S. sales (AUD$M) only partially reflected, due to time
Slide 15: Key expenditure items
Key expenditure items Capital raise proceeds funding R&D for therapeutic program advancement • Cost of goods sold includes kit manufacturing costs, dispensing fees and once-off production- KEY EXPENDITURE ITEMS related costs associated with the U.S. launch (AUD$M) 30.0 • R&D expenditure primarily di
Slide 16: Clinical programs update
Clinical programs update 16
Slide 17: Core pipeline: oncology and rare diseases
Core pipeline: oncology and 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–RADmA
Slide 18: Clinical development highlights 1H 2022
Clinical development highlights 1H 2022 Phase III imaging trial completes, progress across multiple therapeutic trials v RENAL CANCER P R O S TAT E C A N C E R GLIOBLASTOMA RARE DISEASES IMAGING & THERAPY THERAPY IMAGING & THERAPY PORTFOLIO • Phase III ZIRCON study • ProstACT SELECT • Finalising pat
Slide 19: Carbonic Anhydrase IX (CAIX) program
Carbonic Anhydrase IX (CAIX) program Phase III imaging study complete, potential to develop as a pan-cancer target L E A D C A N D I D AT E S S C I E N T I F I C R AT I O N A L E Dx: TLX250-CDx (89Zr-girentuximab) • CAIX is a tumour-associated antigen expressed in up to 95% of ccRCC cases and many T
Slide 20: TLX250-CDx: follow-on to Illuccix
TLX250-CDx: follow-on to Illuccix “Breakthrough” designation in an area of growing need Renal cancer rates have doubled in the last 50 years, to 400,000 cases worldwide in 20201 and the incidental detection of small renal masses is increasing • Current imaging cannot reliably distinguish whether the
Slide 21: TLX250 therapy in renal cancer and other indications
TLX250 therapy in renal cancer and other indications Combination therapy strategy could expedite the commercial opportunity S TA R L I T E P H A S E I I S T U D I E S C O L L A B O R AT I O N W I T H M E R C K K G a A I N C O M B I N AT I O N W I T H I M M U N O T H E R A P Y D N A D A M A G E R E P
Slide 22: Prostate-specific membrane antigen (PSMA) program
Prostate-specific membrane antigen (PSMA) program A differentiated approach in the emerging field of PSMA therapy L E A D C A N D I D AT E S S C I E N T I F I C R AT I O N A L E TLX591 (177Lu-rosopatamab) • Antibodies are functionally specific for tumour- expressed PSMA and do not “hit” most TLX592
Slide 23: PSMA competitive landscape
PSMA competitive landscape TLX591 Potential advantages of the antibody approach Liver (preferred clearance organ) ANTIBODY (TLX591) SMALL MOLECULE SMALL Functionally specific for tumour-expressed Taken up by endogenous PSMA Fecal MOLECULE PSMA, does not “hit” most endogenous PSMA excretion Off-targe
Slide 24: ProstACT program overview
ProstACT program overview Multiple opportunities to deliver insights into TLX591, across multiple patient segments Radiogenomics study (Phase I) Combination with EBRT1 in Pivotal Phase III study in patients oligometastatic early recurrence with mCRPC2 progressing on 1st (Phase II) line novel androge
Slide 25: 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: IIT studies Radical prostatectomy non-castrate), apalutamide, Docetaxel; Sipuleucel-T; A
Slide 26: Radiation retention in tumour with antibody therapy
Radiation retention in tumour with antibody therapy Demonstrates high retention of 177Lu in the tumour • Biodistribution data indicates TLX591 antibody is retained in the tumour with high activity still at day seven • Longer-term retention of TLX591 in the tumour (and metastases) may maximise the ce
Slide 27: Pipeline expansion highlights
Pipeline expansion highlights 27
Slide 28: In-licensing of olaratumab from Eli Lilly and Company
In-licensing of olaratumab from Eli Lilly and Company Established safety profile, promising “theranostic” target • Olaratumab was originally developed by Lilly as a “naked” Annual (non-radiolabelled) monoclonal antibody incidence rates of • Soft tissue sarcoma (STS) has a poor prognosis (12-18 STS1
Slide 29: Telix AI artificial intelligence platform
Telix AI™ artificial intelligence platform Potential to enhance efficiency and accuracy of both imaging and therapy • Telix AI™ artificial intelligence platform being developed in partnership with Invicro LLC • Seeks to increase efficiency and reproducibility of clinical images • Automatically separ
Slide 30: Advanced manufacturing and supply chain
Advanced manufacturing and supply chain Working with industry leading partners to service patients in all major markets Build-out of radiopharmaceutical production facility (Brussels South) underway • Infrastructure works enabling commencement of clean room and hot cell installation for nine GMP man
Slide 31: Outlook
Outlook 31
Slide 32: Catalysts
Catalysts ZIRCON Phase III ProstACT SELECT study readout / BLA data readout Regulatory filing submission process Telix AI™ update ProstACT Brussels South ProstACT GLOBAL manufacturing TARGET expansion facility in operation patient dosing UPCOMING MILESTONES 2H 20221 LOOKING AHEAD TO 2023 I-PAX 1 one
Slide 33: Thank you and questions
Thank you and questions Investor relations contact: Kyahn.williamson@telixpharma.com TELIX PHARMACEUTICALS LIMITED (ASX:TLX)
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