Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

Telix Pharmaceuticals Ltd AGM Information 2025

May 20, 2025

31324_rns_2025-05-20_bbfc9c49-9b12-4aab-8db9-892a32b73c7d.pdf

AGM Information

Open in viewer

Opens in your device viewer

==> picture [131 x 55] intentionally omitted <==

Annual General Meeting of Shareholders

Telix Pharmaceuticals ASX: TLX | NASDAQ: TLX 10.00am (Sydney time) 21 May 2025

==> picture [73 x 30] intentionally omitted <==

Images used with permission.

Important information

This presentation should be read together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) and the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

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. The information and opinions contained in this presentation are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this presentation, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in this presentation.

This presentation may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Telix’s actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

This presentation also contains estimates and other statistical data made by independent parties and by Telix relating to market size and other data about its industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data and estimates. In addition, projections, assumptions and estimates of Telix’s future performance and the future performance of the markets in which it operates are necessarily subject to a high degree of uncertainty and risk.

Telix’s first generation PSMA-PET imaging product, gallium-68 ([68] Ga) gozetotide injection (also known as[68] Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA), by the Australian Therapeutic Goods Administration (TGA), by Health Canada, by the Brazilian Health Regulatory Agency (ANVISA), by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), by the French National Agency for the Safety of Medicine and Health Products (ANSM) and in multiple countries within the European Economic Area (EEA) following a positive decentralized procedure (DCP) opinion by the German Federal Institute for Drugs and Medical Devices (BfArM). Gozellix® (kit for the preparation of gallium-68 ([68] Ga) gozetotide injection) has been approved by the U.S. FDA.

Telix’s osteomyelitis (bone infection) imaging agent, technetium-99m ([99m] Tc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix’s miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction.

Telix’s results are reported under International Financial Reporting Standards (IFRS). This presentation includes various non-IFRS financial information to reflect its underlying performance. These non-IFRS measures include Adjusted EBITDA. Non-IFRS measures have not been subject to audit or review. For further information on the reconciliation of non-IFRS financial information to Telix's statutory measures, reasons for usefulness and calculation methodology, please refer to the Alternative performance measures section of Telix’s 2024 Annual Report.

This presentation has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. Pixclara and Zircaix brand names subject to final regulatory approval.

==> picture [73 x 30] intentionally omitted <==

==> picture [960 x 34] intentionally omitted <==

----- Start of picture text -----

2
----- End of picture text -----

FAPi therapy (TLX400) in metastatic medullary thyroid cancer

Pretreatment

==> picture [73 x 30] intentionally omitted <==

PostTLX250-CDx PET positive scan showing treatment CAIX expression (Phase III ZIRCON study)

Our mission is to be the global leader in radiopharmaceuticals Telix is delivering to its growth strategy

==> picture [186 x 229] intentionally omitted <==

----- Start of picture text -----

Deliver
our late-stage
therapeutic pipeline
----- End of picture text -----

==> picture [186 x 229] intentionally omitted <==

----- Start of picture text -----

Build
the next generation of
radiopharmaceuticals
----- End of picture text -----

==> picture [186 x 229] intentionally omitted <==

----- Start of picture text -----

Grow
our industry-leading
precision medicine
business
----- End of picture text -----

==> picture [186 x 229] intentionally omitted <==

----- Start of picture text -----

Expand
our global
infrastructure for
product delivery
----- End of picture text -----

==> picture [73 x 30] intentionally omitted <==

==> picture [960 x 34] intentionally omitted <==

----- Start of picture text -----

4
----- End of picture text -----

A diversified, vertically-integrated radiopharma business Telix has built a foundation for sustainable growth

==> picture [298 x 326] intentionally omitted <==

----- Start of picture text -----

Revenue (US$M)
600
517
+55%
400 783.2
334 Year on year
502.5
200 (YoY)
0
2023 2024
Adjusted EBITDA [2] (US$M)
80
60 67 +76%
40
YoY
38
20
0
----- End of picture text -----

==> picture [81 x 99] intentionally omitted <==

Expanding, global commercial portfolio

  • Illuccix®, Gozellix® and Scintimun®: approved products

  • • Commercially active in 35 countries[1]

  • Illuccix® pathway towards marketing authorization established for Japan and China

==> picture [81 x 100] intentionally omitted <==

Broad and deep theranostic pipeline

  • ProstACT Global: Part 1 interim readout

  • Glioblastoma and renal therapy: pivotal trials planned to initiate in 2025

  • Next-generation assets advancing into the clinic

==> picture [81 x 99] intentionally omitted <==

Global infrastructure to meet future demand

  • Strengthen supply chain resilience and localized manufacturing

  • • Integration of RLS Radiopharmacies further diversifies revenue

  • • Recent acquisitions add specialist skills and capabilities

2023 2024

All figures in this presentation are recast in US$ and provided on an unaudited basis.

==> picture [73 x 30] intentionally omitted <==

  1. Australia, Austria, Brazil, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK, U.S.

  2. Earnings before interest, tax, depreciation, amortization, U.S. listing costs, acquisition transaction costs and other gains/(losses) (net).

Capital allocation framework Strategically reinvesting earnings to deliver value-creation opportunities

Commercial focus / cash generation Diversify and grow revenue + increase operating leverage

Four core areas of investment focused on delivering return-on-capital

R&D: Late and earlystage pipeline development

Optimizing commercial performance

Reinvesting earnings in the business Operating expenditure to deliver value-creation opportunities

Supply chain resilience Strategic growth and production opportunities capacity

Capital investment

==> picture [73 x 30] intentionally omitted <==

==> picture [960 x 34] intentionally omitted <==

----- Start of picture text -----

6
----- End of picture text -----

2025 focus: Global commercial expansion


Launch preparation for new markets and new products
U.S.
International
• Gozellix: follow-on PSMA
product, approved March
2025
• Illuccix®: UK and
European country rollout
from H1 2025
• Illuccix® China Phase 3
study completed
• Zircaix1BLA2filed with
FDA December 2024
• Expanded access program
at >30 sites globally
• Included in EAU3guidelines as
an emerging technology
• Engagement with EU
regulator and manufacturers
• China bridging study
commenced
• Preparing to re-file U.S.
NDA4
• Expanded access
program active in the U.S.
Pixclara1:Targeted global
regulatory filings,
opportunities in select
markets where access is
currently restricted
Scintimun®:Relaunch in
current indication
1.
Provisional brand name subject to final regulatory approval.
2.
Biologics license application.
3.
European Association of Urology Guidelines on Renal Cell Carcinoma (April 2024).
4.
New drug application.
7

Telix PSMA multi-product strategy Growing the U.S. market as leaders in PSMA imaging

==> picture [247 x 107] intentionally omitted <==

==> picture [451 x 254] intentionally omitted <==

  • Protect and grow market share: Through customer experience and innovation

  • Expand patient reach, customer choice: Differentiated as the only company with two approved PSMA imaging agents

  • Increase clinical utilization: Labelexpansion study commencing in 2025

  • Product development: Pipeline of new products, delivering continued innovation in PSMA imaging

==> picture [73 x 30] intentionally omitted <==

Sample U.S. campaign for U.S. approved product, intended for U.S. healthcare professional audience only. Registrations vary country to country, always refer to local label and approval status. Gozellix is not currently approved in any country outside of the U.S.

==> picture [960 x 34] intentionally omitted <==

----- Start of picture text -----

8
----- End of picture text -----

Therapeutics: Core to our strategy Momentum building across our pipeline of differentiated assets

==> picture [257 x 144] intentionally omitted <==

Progress late-stage therapeutic pipeline

  • Accelerate ProstACT GLOBAL pivotal trial of TLX591, first rADC[1] in 1L/2L mCRPC[2]

  • Submit INDs to progress potential first-in-class radiotherapeutics to pivotal phase in other core areas

ꟷTLX250 in ccRCC[4 ] and TLX101 in recurrent glioblastoma

==> picture [240 x 144] intentionally omitted <==

Advance next-generation therapeutic programs

  • Expand development in prostate cancer with[225] Ac-TLX592 & TLX090 for bone pain in end-of-life setting

  • Expand development in neuro-oncology with[211] At-TLX102

  • Explore multi-indication asset strategies leveraging validated pan-tumor targets, CAIX[5] and FAP[6]

  • ClinicalTrials.gov ID: NCT06520345.

  • Radio antibody-drug conjugate.

==> picture [73 x 30] intentionally omitted <==

  1. Metastatic castrate resistant prostate cancer.

  2. Clear cell renal cell carcinoma – most common form of kidney cancer.

  3. Carbonic anhydrase IX.

  4. Fibroblast Activated Protein

New clinical data reports promising efficacy data for TLX101 IPAX-Linz study substantiates patient benefit in high-grade glioma

  • Phase 2, single-arm, investigator-initiated study, enrolled eight patients

  • Well tolerated , no serious adverse events reported

  • Median overall survival of 32.2 months from initial diagnosis and 12.4 months from initiation of treatment[1]

  • Adaptive dosing regime, TLX101 in combination with external beam radiation therapy (EBRT)

  • Findings consistent with IPAX-1 study, in a more advanced and complex study cohort

  • Telix’s investigational imaging agent TLX101-CDx used as companion diagnostic in the study

Pivotal trial in recurrent setting planned for 2025: Investigational New Drug (IND) filing planned for mid-year

Glioblastoma patient (salvage) with clinically stable disease 18 months from initiation of TLX101 therapy[2]

==> picture [111 x 121] intentionally omitted <==

==> picture [91 x 107] intentionally omitted <==

==> picture [86 x 106] intentionally omitted <==

==> picture [407 x 152] intentionally omitted <==

----- Start of picture text -----

Baseline T = 0 [3] TLX101 #1 & #2 [4] T = 10 mos
TLX101 #3 & #4 [4] T = 16 mos T = 18 mos
----- End of picture text -----

==> picture [84 x 13] intentionally omitted <==

----- Start of picture text -----

T = 18 mos
----- End of picture text -----

Patient representative scans - individual results may vary.

==> picture [73 x 30] intentionally omitted <==

  1. Telix ASX disclosure 16 April 2025. Data presented at NMN May 2025. 2. TLX101 Compassionate Use program. Case study presented at NMN symposium May 2025. Credit A. Braat, UMC Utrecht.

==> picture [960 x 34] intentionally omitted <==

----- Start of picture text -----

10
----- End of picture text -----

TLX101-CDx ([18F] FET) PET (positron emission tomography). Overlay post therapy SPECT (single photon emission computed tomography).

Expanding global infrastructure

Localized production to service major global markets

Our strategy is to: Build competitive advantage through resources and expertise Scale to meet rapid growth and demand

Build partnerships to drive success

==> picture [580 x 310] intentionally omitted <==

----- Start of picture text -----

Telix Partners
----- End of picture text -----

==> picture [73 x 30] intentionally omitted <==

==> picture [960 x 34] intentionally omitted <==

----- Start of picture text -----

11
----- End of picture text -----

Case study: Lead generator

Recently acquired companies enable development and commercial pathway

==> picture [150 x 56] intentionally omitted <==

Developed and validated a breakthrough 212 generator Pb technology for the production of lead212 ([212] Pb) and Lead-212 generator successfully completed first production

Alpha therapy Distribution

Novel biologics development Telix Targeting platform and clinically validated Technology candidates with (formerly ImaginAb) pharmacokinetic characteristics suited to Lead-212

==> picture [98 x 43] intentionally omitted <==

To support future scale up through engineering and expertise

U.S. footprint with capacity for lead generator installation to support future nationwide distribution

==> picture [132 x 57] intentionally omitted <==

==> picture [73 x 30] intentionally omitted <==

==> picture [960 x 34] intentionally omitted <==

----- Start of picture text -----

12
----- End of picture text -----

Case study: ARTMS

Scaling-up production to meet future demand

==> picture [123 x 55] intentionally omitted <==

QUANTM Irradiation System® (QIS®) Production technology for isotopes including[68] Ga, 89Zr, 64Cu, and 99mTc: clean, large-scale, cost-efficient and translatable to all upcoming industry-based products

ARTMS’ QIS enables:

==> picture [112 x 64] intentionally omitted <==

Multi-Curie production of[68] Ga extending patient reach and driving radiopharmacy efficiencies

==> picture [91 x 69] intentionally omitted <==

Centralized, large-scale, costeffective production of Zr-89, for use with a biologic

==> picture [109 x 47] intentionally omitted <==

Expanded distribution and enhanced production capacity for cyclotrons, to be installed through RLS and partner networks

==> picture [73 x 30] intentionally omitted <==

Zircaix is a provisional brand name and subject to regulatory approval

==> picture [960 x 34] intentionally omitted <==

----- Start of picture text -----

13
----- End of picture text -----

Delivering the plan

Near-term catalysts

==> picture [40 x 53] intentionally omitted <==

Deliver our late-stage therapeutic pipeline

==> picture [40 x 53] intentionally omitted <==

Build the next generation of radiopharmaceuticals

==> picture [40 x 53] intentionally omitted <==

Grow our industryleading precision medicine business

==> picture [40 x 53] intentionally omitted <==

Expand our global infrastructure for product delivery

==> picture [77 x 26] intentionally omitted <==

----- Start of picture text -----

2025
----- End of picture text -----

IPAX-Linz (TLX101) therapy study readout ProstACT Global (TLX591) Ph 3 IND granted in China ZOLAR (TLX300) patient dosing

Novel biologics platform and Tx assets transactions completion Gozellix® approval (U.S.)

Illuccix® EEA[1] , UK and Brazil approvals Illuccix® China Ph 3 bridging study complete

==> picture [73 x 30] intentionally omitted <==

  1. European Economic Area.

  2. Subject to regulatory approval.

RLS acquisition completion TMS Brussels South GMP accreditation ProstACT Global Ph 3 Part 1 complete

IPAX-2 (TLX101) therapy study complete TLX250 program update TLX592 alpha therapeutic trial commencement[2] PSMA biopsy expansion study commencement[2]

TLX101, TLX250 pivotal trials commencement[2] TLX252 alpha trial commencement[2] ZOLAR trial Part A complete

Zircaix[3] anticipated FDA approval decision (U.S.) SubtlePET + Zircaix[3] (combo) AI filing and approval decision (U.S.)

Gozellix filing (Aus)

Illuccix® Japan Ph 3 trial enrolment[2]

  1. Brand name subject to final regulatory approval.

==> picture [73 x 30] intentionally omitted <==

Illustration showing TLX250 binding to carbonic anhydrase IX and internalization