Slide 1: 2022 Full Year Results
2022 Full Year Results Telix Pharmaceuticals (ASX:TLX) 27 February 2023
Slide 2: Disclaimer
Disclaimer This presentation is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, the United States and the United Kingdom). This presentation contains summary information about Telix Pharmaceuticals Limi
Slide 3: Telix is a recognised leader in radiopharmaceuticals
Telix is a recognised leader in radiopharmaceuticals Industry-leading assets and success in a high-growth sector Telix has demonstrated expertise at every step of Global nuclear the radiopharmaceutical product delivery process Three pillars of medicine market future value creation growth forecast: C
Slide 4: Key financial metrics
Key financial metrics Telix finishes 2022 in a healthy financial position Total revenue Gross margin Expenditure Cash balance Net loss after tax (ex COGS1) $160.1M 62% $166.3M $116.3M $104.1M Up 20x Steady improvement 104% of revenue in As of 31 Dec 2022 Up 29% (2021: $7.6M) since commercial FY2022
Slide 5: Our growth strategy
Our growth strategy Creating long term benefit for patients and shareholders Use Illuccix as a • Establish commercial operations and build commercial launch pad engagement with the urology customer base Commercialise the • Leverage investment in commercial infrastructure and diagnostics portfolio re
Slide 6: Our growth strategy: Milestones and achievements in 2022
Our growth strategy Milestones and achievements in 2022 Use Illuccix as a • Successful U.S. launch commercial launch pad • Strong foothold in the growing PSMA-PET imaging market Commercialise the • Phase III ZIRCON study delivered highly positive results diagnostics portfolio • Preparing regulatory
Slide 7: Core pipeline: Oncology and rare diseases
Core pipeline: Oncology and rare diseases Prostate PSMA1 PHASE 1 PHASE 2 PHASE 3 COMMERCIAL 68Ga Imaging Small molecule TLX591-CDx (68Ga-PSMA-11, Illuccix®) Antibody 177Lu Therapy TLX591 (177Lu-rosopatamab) Kidney CAIX2 PHASE 1 PHASE 2 PHASE 3 COMMERCIAL 89Zr Imaging Antibody TLX250-CDx (89Zr-girent
Slide 8: Strong commercial launch in the U.S.
Strong commercial launch in the U.S. Use Illuccix as a commercial launch pad Sustained month-on-month growth since launch Revenue from U.S. sales of Illuccix $149.7M (US$100.4M) in first nine months since launch Revenue from U.S. Illuccix® sales • In Q4, revenue from U.S. sales of Illuccix up 43% to
Slide 9: The Illuccix difference
The Illuccix difference Use Illuccix as a commercial launch pad Rapidly scalable model to meet demand in the growing U.S. market • Rapidly scalable model with ability to reach ILLUCCIX N E T W O R K E X PA N S I O N 90% of PET sites across the U.S. and deliver hyper-localised service • Sites have be
Slide 10: The Illuccix difference
The Illuccix difference Use Illuccix as a commercial launch pad Clinical differentiation + optimum scheduling flexibility New scientific publications illustrate 68Ga-PSMA-11 PET/CT Accurate has the most validated accuracy1-3 compared to other PSMA- More sensitive than 18F-based imaging agents PSMA i
Slide 11: Case study: Initial staging
Case study: Initial staging1 Use Illuccix as a commercial launch pad Critical information for clinical decision making at initial staging Pelvic LNs3 Femur head Pelvic LNs In a prospective study of Patient case metastasis4 Metastasis metastasis 197 patients evaluated PET5 with 68Ga-PSMA-11 at Before
Slide 12: Case study: Suspected recurrence
Case study: Suspected recurrence Use Illuccix as a commercial launch pad Impact of treatment decisions and outcomes for patients with BCR1 In a retrospective follow- Patient case C7 Vertebral body metastasis3 Left Iliac metastasis up of treatment decisions for BCR Before imaging with Illuccix: PET p
Slide 13: Expanding the commercial portfolio
Expanding the commercial portfolio Commercialise the diagnostics portfolio Preparing to launch two additional imaging agents in 2024 TLX250-CDx: TLX101-CDx (18F-FET): Renal cancer imaging Brain cancer imaging • TLX250-CDx provides a way to non-invasively • Estimated 81,900 patients worldwide and 14,
Slide 14: ZIRCON co-primary endpoints
ZIRCON co-primary endpoints Commercialise the diagnostics portfolio Sensitivity and specificity thresholds exceeded by all three readers1 Overall % Full analysis set (N=284) Reader 1 Reader 2 Reader 3 (95% CI2) Sensitivity, % 84.13 85.19 87.30 85.5 (79.8, 89.8) Lowest bounds, Wilson 95% CI 78.24 79.
Slide 15: ZIRCON clinical case in a complex cyst
ZIRCON clinical case in a complex cyst Commercialise the diagnostics portfolio Potential support for clinical decision making MRI1 axial PET axial Fused PET/ CT coronal Diagnostic challenge: Clinical management: • 42 yr male • 89Zr-girentuximab PET scan clearly • Surgery - radical nephrectomy • 3.1
Slide 16: ZIRCON clinical case in a 1 cm mass
ZIRCON clinical case in a 1 cm mass Commercialise the diagnostics portfolio Potential support for clinical decision making MRI axial PET axial Fused PET/ CT coronal Diagnostic challenge: Clinical management: • 57 yr male with 1 cm lesion found • 89Zr-DFO-girentuximab PET clearly • Partial nephrectom
Slide 17: TLX101-CDx value proposition in glioma
TLX101-CDx value proposition in glioma Commercialise the Potential first commercial FET-PET imaging agent for U.S. market diagnostics portfolio Reduce and/or replace Provide key information surgical biopsies at initial • FET-PET has the potential to provide a rapid and conclusive diagnosis 1 diagnos
Slide 18: ProstACT prostate cancer therapy program
ProstACT prostate cancer therapy program Unlock the value in the therapeutic pipeline A differentiated PSMA-targeting therapy candidate • SELECT study approaching target Lower tumour burden High tumour burden enrolment, opportunities for data readouts in H1 2023 • TARGET study dosing patients • Manu
Slide 19: TLX101: Further studies progressing
TLX101: Further studies progressing Unlock the value in the therapeutic pipeline Promising data warrants investigation in a front-line setting • IPAX-1 multi-centre Phase I trial of TLX101 in combination with EBRT in patients with recurrent glioblastoma multiforme (GBM) completed in 2021 • Final da
Slide 20: Our approach to supply chain and manufacturing
Our approach to supply chain and manufacturing Strengthen supply chain and manufacturing Extensive network enhanced with added in-house capability Industry-leading supply Global manufacturing Expansive distribution In-house chain partners and logistics network network manufacturing / R&D Clinical an
Slide 21: Our European production facility
Our European production facility Strengthen supply chain and manufacturing Brussels South facility expected to be operational in 2023 • Brussels South facility will serve as the primary manufacturing site for commercial and clinical supply in Europe • Integral to R&D, particularly manufacturing scal
Slide 22: Research and innovation: Five areas of focus
Research and innovation: Five areas of focus R Expand the pipeline Telix has made progress across all focus areas in 2022 Targeted Radiation (TR) Targeted Alpha Tumour Artificial Radio-guided + Immuno-oncology therapy Microenvironment intelligence (AI) surgery TR sets the groundwork Next generation
Slide 23: Research pipeline: Novel targets and technologies
Research pipeline: Novel targets and technologies ASSET TARGET ISOTOPE DESCRIPTION STATUS Immuno-oncology 177Lu TLX250 + Merck KGaA DNA Damage Response Inhibitor (DDRi) candidate in Phase Ib study (STARSTRUCK) TLX250 Combo CAIX patients with CAIX-expressing solid tumours to commence H1 2023 Targeted
Slide 24: Collaboration with Merck KGaA
Collaboration with Merck KGaA Expand the pipeline TLX250 Combo: TLX250 + DNA Damage Response Inhibitor (DDRi) • Pre-clinical results show TLX250 in combination with DDRi enhances the Summary of pre-clinical results in potency of treatment at a lower dose Xenograft mice (TLX250 Combo) • TLX250 Combo
Slide 25: Financial Commentary
Financial Commentary OTelix
Slide 26: Commercial launch drives 20x increase in revenue
Commercial launch drives 20x increase in revenue U.S. Illuccix sales delivers growth throughout the year • Group revenue up 20x to $160.1M (2021: $7.6M) Group revenue ($M) 160.0 • U.S. revenue from Illuccix the main driver with 136.1 $149.7M ($US100.4M) recorded since commercial 140.0 launch in Apri
Slide 27: Growing revenue building a sustainable business
Growing revenue building a sustainable business Key expenditure has reduced as a percentage of sales • Gross margin of 62% for FY2022 Revenue ($M) and gross margin percentage (%) 160.0 63% 64% • Improvement of 7 basis points from H1 (56%) to 140.0 62% H2 (63%) due to manufacturing efficiencies and 1
Slide 28: Income statement summary
Income statement summary Investing for future growth, while delivering an improvement in profit/(loss) • Gross profit substantially up 1870% YOY FINANCIAL YEAR HALF-YEAR • H1 includes one-off launch costs, while H2 reflects normalised manufacturing 2022 2021 Var. Var. H2 H1 Var. Var. costs and full
Slide 29: Improving operating cash flow
Improving operating cash flow Q4 delivers first quarter of net cash inflow from operating activities • Telix finishes 2022 in a stronger financial Operating cash flow by quarter ($M)1 position with: 5.0 1.6 0.0 • Improved balance sheet, with net assets of $80.0M and cash reserves of $116.3M (5.0) (5
Slide 30: Four major focus areas in 2023
Four major focus areas in 2023 Value creating catalysts across the imaging and therapeutic pipeline ProstACT New Drug Illuccix® - Biologics License GLOBAL patient Application (NDA) continued revenue Application (BLA) recruitment and for brain cancer growth and global submission for ProstACT imaging
Slide 31: Upcoming catalysts
Upcoming catalysts Illuccix® - ProstACT Four key continued GLOBAL patient BLA submission NDA for brain revenue growth recruitment and catalysts for TLX250-CDx cancer imaging data readout and global (TLX101-CDx) rollout ProstACT SELECT EXPECTED MILESTONES 2023 Additional Prostate and milestones Bruss
Slide 32: Contact details
Contact details: Kyahn Williamson SVP Investor Relations and Corporate Communication kyahn.williamson@telixpharma.com 32