AI assistant
Telix Pharmaceuticals Ltd — Capital/Financing Update 2022
Jan 23, 2022
31324_rns_2022-01-23_190ceca4-a738-4378-9835-912ce12cedfa.pdf
Capital/Financing Update
Open in viewerOpens in your device viewer
==> picture [271 x 234] intentionally omitted <==
==> picture [176 x 97] intentionally omitted <==
Precision Oncology See it. Treat it.
Capital raise presentation
January 2022
Not for release on U.S. wire services or distribution in the United States
Im ortant notice and disclaimer p
This Presentation contains summary information about Telix Pharmaceuticals Limited ACN 616 620 369 ( Telix or the Company ) and its activities as at 24 January 2022 ] The information in this Presentation is of a general nature and does not purport to be complete or comprise all information which a shareholder or potential investor may require in order to determine whether to deal in Telix shares. It should be read in conjunction with Telix’s other periodic and continuous disclosure announcements lodged with the Australian Securities Exchange, which are available at www.asx.com.au.
This Presentation includes information about Telix’s institutional placement ( Placement ) of new, fully paid ordinary shares ( Shares or New Shares ) and share purchase plan ( SPP ), together, the Offer . Not an offer
This Presentation is not a prospectus, product disclosure statement or other offering document under Australian law, or any other law. This Presentation is for information purposes only and is not an invitation or offer of securities for subscription, purchase or sale in any jurisdiction. In particular, this Presentation has been prepared for release in Australia and is not for distribution or release in the United States. This Presentation does not constitute an offer to sell, or the solicitation of an offer to buy, any securities in the United States (or any other jurisdictions).
Restrictions
Any securities offered in connection with this Presentation have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended ( US Securities Act ) or the securities laws of any state or other jurisdiction of the United States, and may not be offered or sold in the United States except in transactions exempt from, or not subject to, registration under the US Securities Act and applicable US state securities laws. This Presentation may not be distributed in the United States, or any other jurisdiction, except in accordance with the legal requirements applicable in such jurisdiction. The distribution of this Presentation outside Australia may be restricted by law, and persons into whose possession this Presentation comes should observe any such restrictions. Any failure to comply with such restrictions may violate applicable securities laws. See section “International offer restrictions” for more information.
Not financial product advice
This Presentation does not constitute financial product, investment, legal, taxation or other advice or a recommendation to acquire Telix shares and has been prepared without taking into account the objectives, financial situation or needs of individuals. Before making an investment decision, prospective investors should consider the appropriateness of the available information, having regard to their own objectives, financial situation and needs and seek financial, legal and taxation advice appropriate to their jurisdiction. The Company is not licensed to provide financial advice in respect of its shares.
Investment risk
An investment in Telix shares is subject to investment and other known and unknown risks, some of which are beyond the control of the Company. Telix does not guarantee any particular rate of return or the performance of its shares.
Disclaimer
While the information in this Presentation has been prepared in good faith and with reasonable care, no representation or warranty, express or implied, is made as to the fairness or correctness of the information, opinions and conclusions contained in this Presentation. This Presentation is subject to change without notice. To the maximum extent permitted by law, Telix, the joint lead managers to the Placement ( Joint Lead Managers ) and each of their respective advisers, affiliates, related bodies corporate, directors, officers, partners, employees, agents or advisers ( Extended Parties ):
-
-expressly excludes and disclaims all liability for any direct or indirect loss arising from the use of this Presentation or its contents or otherwise arising in connection with it, including without limitation, any liability from fault or negligence; and
-
-makes no representation or warranty, express or implied, as to the fairness, currency, accuracy, reliability or completeness of information, opinions, forward-looking statements and conclusions in this Presentation. Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [100 x 56] intentionally omitted <==
Disclaimer (cntd)
No person is authorized to give any information or make any representation in relation to the Offer that is not included in this Presentation. Any information not contained in this Presentation may not be relied on as having been authorized by Telix. The Joint Lead Managers and their Extended Parties take no responsibility for any information in this Presentation, for any action taken by you and make no recommendation regarding the Placement nor any representations regarding this Presentation or the Offer. The Joint Lead Managers disclaim any fiduciary duty between them and the recipients of this Presentation.
You acknowledge and agree that allocations in the Placement are at the sole discretion of Telix and/or the Joint Lead Managers.
Past performance
Past performance information, including past share price performance, should not be relied upon as an indication of future performance.
Future performance
This Presentation contains certain references to forecasts, estimates, assumptions and other forward-looking statements and statements regarding the intent, belief or current expectations of Telix. The words “likely”, “expect”, “aim”, “should”, “could”, “may”, “anticipate”, “predict”, “believe”, “plan” and other similar expressions are intended to identify forward-looking statements.
Forward-looking statements, opinions and estimates provided in this Presentation are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current market conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. This Presentation contains such statements, which are subject to risk factors associated with an investment in Telix. The Company believes that these statements are reasonable, but they may be affected by a range of variables which could cause actual results or trends to differ materially.
Forward-looking statements involve known and unknown risks, uncertainties and assumptions and other important factors that could cause actual results, performance or achievements of Telix to be materially different from future results, performances or achievements expressed or implied by such statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Presentation.
Financial data
All references to dollars ($) and cents are to Australian currency, unless otherwise stated. Market and industry data
This Presentation contains data relating to the industries, segments and markets in which the Company operates ( Industry Data ). Unless otherwise stated, this information has been prepared by Telix using both publicly available data and its own internally generated data. Telix’s internally generated data is based on estimates and assumptions that the directors and management of the Company believe are reasonable. In addition to the Industry Data, the Presentation contains third party market data, estimates and projections. There is no assurance regarding the accuracy of such information and the third party information, and the Industry Data, has not been independently verified by Telix.
Withdrawal and cooling off rights
Telix reserves the right to withdraw or vary the timetable for the Offer without notice. Cooling off rights do not apply to an investment in New Shares.
Joint Lead Managers
The Joint Lead Managers are acting as joint lead managers to the Placement, for which they expect to receive fees. The Joint Lead Managers are acting for and providing advice to Telix in relation to the Placement and will not be acting for Telix shareholders. Each Joint Lead Manager is acting as independent contractor on arm’s length terms and the engage of each Joint Lead Manager by Telix is not intended to create any agency or other relationship between the Joint Lead Managers, Telix and Telix shareholders.
Contents
==> picture [126 x 76] intentionally omitted <==
| Executive summary | 4 |
|---|---|
| Offer details | 9 |
| Company and programs overview | 13 |
| • Illuccix® imaging |
21 |
| • Prostate cancer therapy |
27 |
| • Renal cancer program |
38 |
| • Rare diseases program |
45 |
| • Future value creation |
51 |
| Key risks | 55 |
| International selling restrictions | 58 |
Telix Pharmaceuticals Limited (ASX: TLX)
Executive summary
==> picture [56 x 56] intentionally omitted <==
First commercial product now approved in the US
==> picture [56 x 57] intentionally omitted <==
Clear growth strategy to unlock value in the pipeline
==> picture [68 x 69] intentionally omitted <==
$200M capital raise to advance diagnostic and therapeutic programs
==> picture [100 x 56] intentionally omitted <==
-
US FDA approval received December 2021
-
Commercial launch ready in US and AU from late Q1, 2022
-
Additional global approvals expected in EU/UK and Canada
-
Use Illuccix as a commercial launchpad
-
Build a high-value diagnostics portfolio
-
Deliver on commercial value of therapeutics
-
• Expand the pipeline
-
$175M placement + $25M share purchase plan
-
Co-founder Sell-Down of four million shares
-
Priced at $7.70 per share
-
To fund late-stage clinical programs & pipeline expansion
Telix Pharmaceuticals Limited (ASX: TLX)
Financial snapshot
ASX: TLX
Market information (as of 19 January 2022)
| Share price | $8.09 |
|---|---|
| Market capitalisation | ~$2.45B |
| Shares on issue | 285M |
| Options on issue | ~18M |
| Cash balance as of 31 December 2021 | $22M |
Top 5 shareholders (as of 5 January 2022)
| Top 5 shareholders (as of 5 January 2022) | |
|---|---|
| Dr. Christian Behrenbruch (CEO & co-founder) | 8.7% |
| Dr. Andreas Kluge (co-founder) | 8.7% |
| China Grand Pharma | 7.3% |
| Fidelity (FIL) | 5.7% |
| UV-CAP GMBH & CO KG | 2.7% |
==> picture [126 x 76] intentionally omitted <==
Share price (12 months to 19 January 2022)
==> picture [429 x 368] intentionally omitted <==
----- Start of picture text -----
AUD
9.00
8.00
7.00
6.00
5.00
4.00
3.00
Mar 2021 May 2021 Jul 2021 Sept 2021 Nov 2021 Jan 2022
----- End of picture text -----
Telix Pharmaceuticals Limited (ASX: TLX)
Strategic priorities
==> picture [145 x 144] intentionally omitted <==
Use Illuccix® as a commercial launchpad
Establish Telix’s leadership in urologic oncology
==> picture [179 x 178] intentionally omitted <==
Create a high-value diagnostic portfolio
Kidney cancer imaging agent addresses major unmet need, builds on Illuccix engagement
==> picture [144 x 144] intentionally omitted <==
Deliver on commercial value of therapeutics
Advance late-stage assets in the core pipeline that benefit from diagnostic market entrance
==> picture [104 x 58] intentionally omitted <==
==> picture [144 x 144] intentionally omitted <==
Expand the pipeline
Novel targets, clinical applications and manufacturing technologies
6
Telix Pharmaceuticals Limited (ASX: TLX)
Focus for 2022 Unlocking the value in our pipeline
==> picture [57 x 57] intentionally omitted <==
Illuccix global rollout
==> picture [59 x 59] intentionally omitted <==
Commercialise diagnostics
==> picture [63 x 50] intentionally omitted <==
Advance core therapeutics
==> picture [57 x 58] intentionally omitted <==
Pipeline and manufacturing
==> picture [100 x 56] intentionally omitted <==
-
US reimbursement
-
Additional global approvals including EU/UK, Canada
-
• Commercial launch from late Q1 2022 (US and AU)
-
Kidney cancer (TLX250-CDx) Phase III readout
-
• Prepare US regulatory filing for TLX250-CDx
-
• US filing planned for brain cancer imaging product
-
ProstACT studies active globally
-
Kidney cancer combination therapy Phase II studies
-
• Initiate Phase II studies in TLX101 and TLX66
-
Seneffe manufacturing / R&D buildout to commence
-
Focus on strategic deals and in-licensing
-
Advance early-stage alpha therapy programs
Telix Pharmaceuticals Limited (ASX: TLX)
Recent milestones and near-term catalysts
==> picture [100 x 56] intentionally omitted <==
Recently completed milestones
-
Illuccix regulatory approvals granted in US and Australia
-
HCPCS[1] reimbursement submitted for Illuccix in the US
-
ProstACT patient recruitment commenced
-
Distributors finalised for major EU markets (subject to regulatory approval)
-
FDA Investigational New Drug (IND) granted for STARLITE 1 & 2 studies for renal cancer therapy
==> picture [65 x 355] intentionally omitted <==
Upcoming milestones: Q1 2022
-
Illuccix commercial launch US and AU
-
US reimbursement for Illuccix:
-
Pass-through code submission (March 2022)
-
• HCPCS code for US reimbursement expected 1 April 2022
-
Illuccix EU marketing authorisation decision
-
ZIRCON Phase III study enrolment completed
-
• IPAX-2 Phase II study launched (glioblastoma)
-
STARLITE Phase II kidney cancer therapy studies progressed
-
Healthcare Common Procedure Coding System
Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [271 x 234] intentionally omitted <==
==> picture [176 x 97] intentionally omitted <==
Precision Oncology See it. Treat it.
Offer Details
Placement and Share Purchase Plan
9
Offer details Placement and Share Purchase Plan to raise $200M
==> picture [100 x 56] intentionally omitted <==
-
Telix is conducting the Offer to raise $200 million, comprising: • an institutional placement to raise $175 million (
-
Offer Structure • a Share Purchase Plan to raise up to $25 million ( SPP
-
and Size
-
an institutional placement to raise $175 million ( Placement ); and
-
a Share Purchase Plan to raise up to $25 million ( SPP ).
-
-
The Placement is being undertaken utilising the Company’s existing Placement capacity under ASX Listing Rule 7.1.
-
Approximately 22.727 million New Shares will be issued under the Placement and up to 3.248 million New Shares will be issued under the SPP.
-
The Placement and the SPP will be conducted at the same Offer Price of $7.70 per New Share, which represents a:
- 4.8% discount to the last closing price of $8.09 on Wednesday, 19 January 2022; and
Offer Price 4.8% discount to the last closing price of $8.09 on Wednesday, 19 January 2022; and • 8.8% discount to the 5 day VWAP of $8.44 as at Wednesday, 19 January 2022. • SPP to existing eligible shareholders in Australia or New Zealand on the record date of 21 January 2022 ( Eligible Shareholders ), up to $30,000 per Eligible Shareholder. SPP Offer Booklet expected to be sent to Eligible Shareholders on Monday, 31 January 2022. Share Purchase • Targeting a maximum of up to $25 million. Plan • SPP offer price of $7.70 per New Share, the same price as the Placement. • Telix reserves the right (in its absolute discretion) to scale back applications under the SPP if demand exceeds $25 million. • Concurrent with the Placement, the Company’s Co-Founders (and Directors), Christian Behrenbruch and Andreas Kluge, have each agreed to sell 2 million shares at the Offer Price, representing 8.1% of each Co-Founder’s shareholding. Co-Founder Sell-Down • Each Co-Founder will hold 22.675 million Shares after the Sell-Down and each will hold approximately 7.3% of Telix’s issued shares on completion of the Offer • Christian Behrenbruch and Andreas Kluge have confirmed to Telix that they will not sell any further shares for at least 12 months from the date of settlement of the Sell-Down. Ranking • New Shares issued under the Placement and SPP will rank equally with existing Telix ordinary shares from their respective issue dates. Joint Lead • Jefferies (Australia) Pty Limited, Taylor Collison Limited and Wilsons Corporate Finance Limited are acting as Joint Lead Managers to the Placement. Managers Underwriting • The Placement and SPP are not underwritten.
• Concurrent with the Placement, the Company’s Co-Founders (and Directors), Christian Behrenbruch and Andreas Kluge, have each agreed to sell 2 million shares at the Offer Price, representing 8.1% of each Co-Founder’s shareholding.
Telix Pharmaceuticals Limited (ASX: TLX)
Source and use of funds
Advancing and expanding the therapeutic (Tx) and diagnostic (Dx) portfolio
==> picture [100 x 56] intentionally omitted <==
-
Complete ProstACT prostate cancer therapy studies (TLX591) including ProstACT GLOBAL Phase III study
-
Complete STARLITE 1 & 2 – Phase II studies in renal cancer therapy (TLX250)
-
Advance three additional therapeutic assets to the point they are ready to undertake a pivotal trial:
-
TLX101: Brain cancer (glioblastoma)
-
TLX66: Phase II study in SALA (amyloidosis)
-
• TLX250: In an additional rare indication (not yet disclosed)
-
Expand diagnostic portfolio including TLX101-CDx for brain cancer, TLX599-CDx (PSMA-SPECT) and Scintimun (bone marrow conditioning) outside of the EU
-
Future pipeline development including targeted alpha therapy
-
Operational costs and working capital requirements will be funded from existing cash plus future revenues
| Source of Funds A$m |
Source of Funds A$m |
|---|---|
| Placement 175 |
|
| Share Purchase Plan Note: assumes SPP is fully subscribed 25 |
|
| TOTAL | 200 |
| Use of Funds | Tx/Dx | A$m |
| Prostate (TLX591) clinical studies | Tx | 90 |
| Kidney (TLX250) clinical studies | Tx | 30 |
| Brain (TLX101) clinical study | Tx | 5 |
| Bone marrow conditioning (TLX66) clinical study (Tx) and Dx commercialisation |
Dx + Tx | 5 |
| Future pipeline and indication expansion | Tx Dx |
37 25 |
| Capital raise costs | 8 | |
| TOTAL | 200 |
Telix Pharmaceuticals Limited (ASX: TLX)
Offer timetable Placement and Share Purchase Plan timetable
==> picture [100 x 56] intentionally omitted <==
| Event | Date (AEDT)* |
|---|---|
| Trading halt | Thursday, 20 January 2022 |
| Record date for SPP | 7.00pm Friday, 21 January 2022 |
| Announcement of the Placement and SPP, trading halt lifted | Monday, 24 January 2022 |
| Settlement of the Placement | Thursday, 27 January 2022 |
| Allotment and normal trading of New Shares issued under the Placement | Friday, 28 January 2022 |
| Dispatch of SPP Offer Booklet, SPP offer opens | Monday, 31 January 2022 |
| SPP offer closing date | Friday, 11 February 2022 |
| Announcement of results of SPP | Wednesday, 16 February 2022 |
| Allotment of New Shares issued under SPP | Monday, 21 February 2022 |
| Normal trading of New Shares issued under SPP | Tuesday, 22 February 2022 |
| Dispatch of holding statements for SPP | Wednesday, 23 February 2022 |
- This timetable is indicative only and is subject to change. Telix reserves the right to alter the timetable at its absolute discretion and without notice, subject to the ASX Listing Rules and Corporations Act and other applicable law.
Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [271 x 234] intentionally omitted <==
==> picture [176 x 97] intentionally omitted <==
Precision Oncology See it. Treat it.
Company and programs overview
Our commercial and core clinical programs
13
==> picture [100 x 56] intentionally omitted <==
Company overview
An established global leader in radiopharmaceuticals
==> picture [441 x 398] intentionally omitted <==
Extensive portfolio of diagnostic and therapeutic assets with compelling clinical data
12 150 patient doses in past 12 months[1] ,
FDA approval for TLX591-CDx (Illuccix[®] )[2]
18 active clinical studies (8 indications)[3]
Leading supply chain and distribution network
80[countries in the Telix distribution network]
11[countries with a manufacturing footprint]
-
Clinical trial doses and magisterial / compassionate use of TLX591-CDx. 12 months from Q4 2020
-
Includes partnered investigator-led studies.
-
U.S. Food and Drug Administration – ASX 20/12/21
Telix Pharmaceuticals Limited (ASX: TLX)
Board of Directors
==> picture [69 x 70] intentionally omitted <==
Kevin McCann
Independent, Non-Executive Director and Chairman
Mr McCann has extensive Board experience with some of Australia’s most recognised companies. He is Chairman of China Matters, a former Chairman of many companies including Macquarie Bank, a member of Champions of Change, a Pro-Chancellor of the University of Sydney, and a Trustee of the Sydney Opera House Trust.
==> picture [70 x 71] intentionally omitted <==
==> picture [126 x 76] intentionally omitted <==
Christian Behrenbruch Group CEO and Managing Director
Dr Behrenbruch has over 20 years of healthcare entrepreneurship and executive leadership experience. He has previously served in a CEO or Executive Director capacity at Mirada Solutions, CTI Molecular Imaging, Fibron Technologies and ImaginAb, Inc.
==> picture [75 x 75] intentionally omitted <==
Oliver Buck Non-Executive Director
Mr Buck is a bio-physicist who has spent his professional career in a variety of entrepreneurial and management positions in industrial companies. Oliver has served as founder and Managing Director of several companies in the fields of manufacturing, technology, demilitarisation, pharmaceuticals and information technologies.
==> picture [69 x 70] intentionally omitted <==
Andreas Kluge Non-Executive Director, Chief Medical Advisor
Dr Kluge has over 20 years of clinical research and development experience, including as Founder, General Manager and Medical Director for ABX-CRO, a full service CRO for Phase I-III biological, radiopharmaceutical and anticancer trials based in Dresden, Germany.
==> picture [70 x 70] intentionally omitted <==
Mark Nelson Non-Executive Director
Dr Nelson is Chairman and Co-Founder of the Caledonia Investments Group, and a Director of The Caledonia Foundation. He is Chairman of Art Exhibitions Australia, a Director of Kaldor Public Art Projects, Director of The Mindgardens Neuroscience Network, and serves as a Governor of the Florey Neurosciences Institute.
==> picture [71 x 72] intentionally omitted <==
Jann Skinner Non-Executive Director
Ms Skinner has extensive experience in audit and accounting and in the insurance industry. She was a partner of PricewaterhouseCoopers for 17 years before retiring in 2004. Jann is a Fellow of both Chartered Accountants Australia & New Zealand and the Australian Institute of Company Directors.
Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [126 x 76] intentionally omitted <==
Global Leadership Team
==> picture [814 x 371] intentionally omitted <==
----- Start of picture text -----
Gabriel Liberatore Douglas Cubbin Colin Hayward
Group Chief Operating Officer Group Chief Financial Officer Group Chief Medical Officer
Jonathan Barlow
David Cade
Richard Valeix
CEO, Asia Pacific Chief Business Development Officer
CEO, EMEA
& General Counsel
Melanie Farris Helen Hovenga Michael Wheatcroft
Chief Governance & Risk Officer, Global Chief People Officer Chief Scientist
Group Company Secretary
Scott Law Tracey Brown Kyahn Williamson
Global Manufacturing Operations SVP Global Clinical Operations SVP Investor Relations & Corporate Comms
----- End of picture text -----
==> picture [68 x 68] intentionally omitted <==
==> picture [70 x 69] intentionally omitted <==
==> picture [70 x 71] intentionally omitted <==
==> picture [71 x 70] intentionally omitted <==
Telix Pharmaceuticals Limited (ASX: TLX)
Our strategy: See It. Treat it. Personalised, precision medicine
Targeted radiation delivery Systemically administered
==> picture [85 x 270] intentionally omitted <==
Unique cancer cell signature (target)
==> picture [180 x 151] intentionally omitted <==
==> picture [42 x 55] intentionally omitted <==
==> picture [42 x 55] intentionally omitted <==
Radioactive isotope Targeting agent (a small molecule or antibody) binds selectively to a cancer cell
==> picture [100 x 56] intentionally omitted <==
Imaging
==> picture [193 x 28] intentionally omitted <==
----- Start of picture text -----
PET [1] scanner TLX591-CDx [2]
(Prostate cancer)
----- End of picture text -----
==> picture [97 x 85] intentionally omitted <==
==> picture [93 x 143] intentionally omitted <==
==> picture [69 x 143] intentionally omitted <==
68Ga, 89Zr (diagnostic isotopes) Enables PET images of cancer
==> picture [141 x 169] intentionally omitted <==
Therapy TLX591 (Prostate cancer) 177Lu, 131I, 225Ac (therapeutic isotopes)
==> picture [71 x 18] intentionally omitted <==
----- Start of picture text -----
Therapy
----- End of picture text -----
Enables precise radiation delivery to the cancer
-
Positron emission tomography.
-
Courtesy of Ammar Chaudhry MD, City of Hope, Duarte CA, USA. Telix Pharmaceuticals Limited (ASX: TLX)
Radiation has never been more important in cancer care Underpinned by the shift from radiation “in a box” to radiation “in a shot”
==> picture [100 x 56] intentionally omitted <==
The evolution from external-beam radiation to systematically-delivered and targeted radiation is transforming the role of radiation in cancer care
From a ‘box’
==> picture [323 x 267] intentionally omitted <==
-
Synergy between imaging and therapy
-
Broad cancer utility
-
Potential to enhance existing drug classes (androgens, taxanes etc.)
-
A vitally important “primer” for immuno-oncology
-
A future cornerstone modality for gene/cell therapy conditioning
To a ‘shot’
==> picture [85 x 270] intentionally omitted <==
Telix is driving the integration of nuclear medicine and medical oncology with more targeted and personalised therapy and patient-friendly dosing regimens
Telix Pharmaceuticals Limited (ASX: TLX)
Telix is pioneering a new cancer modality
==> picture [100 x 56] intentionally omitted <==
Kidney Cancer
| Ph Name Asset Dx/Tx |
Ph Name Asset Dx/Tx |
Ph Name Asset Dx/Tx |
Ph Name Asset Dx/Tx |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| III | TLX250-CDx | Dx | ||||||||
| I/II | TLX250-CDx | Dx | ||||||||
| II | (IIT) | TLX250 | Tx | |||||||
| Ph Name Asset Dx/Tx |
||||||||||
| II | (IIT) | TLX250 | Tx | |||||||
| II | OPALESCENCE (IIT) | TLX250-CDx | Dx | |||||||
| Prostate Cancer | ||||||||||
| I | Emory University (IIT) | TLX591-CDx | Dx | |||||||
| Lung and Ovarian Cancers | Ph Name Asset Dx/Tx |
|||||||||
| Ph Name Asset Dx/Tx |
||||||||||
| III | University of Linz (IIT) | TLX591-CDx | Dx | |||||||
| I | Royal Adelaide (IIT) | APOMAB | Dx/Tx | |||||||
| II | Emory University (IIT) | TLX591-CDx | Dx | |||||||
| Bone Marrow Conditioning | ||||||||||
| II | (IIT) | TLX591-CDx | Dx | |||||||
| Ph Name Asset Dx/Tx |
II | Mem. Sloan Kettering (IIT) | TLX591-CDx | Dx | ||||||
| I/IIa | (IIT) | TLX66 | Tx | |||||||
| N/A* | TLX599-CDx | Dx | ||||||||
| Bladder Cancer | ||||||||||
| III | TLX591 | Tx | ||||||||
| Ph Name Asset Dx/Tx |
I | TLX592 | Tx |
Glioblastoma
| Glioblastoma | ||||
| Ph Name Asset Dx/Tx |
||||
| I/II | TLX101 | Tx |
Breast Cancer
| Ph | Name | Name | Asset | Dx/Tx | ||||
|---|---|---|---|---|---|---|---|---|
| II | OPALESCENCE (IIT) | TLX250-CDx | Dx | |||||
| I | Emory University (IIT) | TLX591-CDx | Dx | |||||
| Lung and Ovarian Cancers | ||||||||
| Ph | Name | Asset | Dx/Tx | |||||
| I | Royal Adelaide (IIT) | APOMAB | Dx/Tx | |||||
| Bone Marrow Conditioning | ||||||||
| Ph | Name | Asset | Dx/Tx | |||||
| I/IIa | (IIT) | TLX66 | Tx | |||||
| Bladder Cancer | ||||||||
| Ph | Name | Asset | Dx/Tx | ||
|---|---|---|---|---|---|
| I/IIa | (IIT) | TLX66 | Tx | ||
| Bladder Cancer | |||||
| Ph | Name | Asset | Dx/Tx | ||
| I | ZiP-UP (IIT) | TLX250-CDx | Dx | ||
| I | PERTINENCE (IIT) | TLX250-CDx | Dx |
*Registry study
Telix Pharmaceuticals Limited (ASX: TLX)
Core pipeline: oncology & rare diseases
==> picture [100 x 56] intentionally omitted <==
==> picture [852 x 396] intentionally omitted <==
Shaded arrows indicate completion expectations in the next 12 months.
*Registry Study
-
Prostate-specific membrane antigen.
-
Carbonic anhydrase IX.
-
Large amino acid transporter 1.
-
Bone marrow conditioning and rare disease.
Telix Pharmaceuticals Limited (ASX: TLX)
- Cluster of differentiation 66.
==> picture [322 x 274] intentionally omitted <==
==> picture [100 x 56] intentionally omitted <==
Telix Pharmaceuticals Limited (ASX: TLX)
Illuccix[®] is now approved in the United States Indication and usage information
==> picture [100 x 56] intentionally omitted <==
Illuccix is a kit for the preparation of gallium-68 ([68] Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer with:
-
Suspected metastasis who are candidates for initial definitive therapy;
-
Suspected recurrence based on elevated serum prostatespecific antigen (PSA) level.
Important Safety Information: https://www.illuccixhcp.com/important-safety-information
Please see full Prescribing Information at http://illuccixhcp.com/s/illuccix-prescribinginformation.pdf
==> picture [391 x 314] intentionally omitted <==
Telix Pharmaceuticals Limited (ASX: TLX)
Market opportunity for prostate imaging is expanding Due to growing incidence rates and practice guidelines
Potential clinical utilisation:
1. Primary staging in newly diagnosed high-risk prostate cancer (NCCN)
2. Biochemical recurrence following prostatectomy or radiation therapy (NCCN)
-
Monitoring of response to systemic therapy (Future)
-
Patient selection for targeted radio-ligand therapy (Future)
US total addressable market (TAM) value
TAM value including EU[2]
==> picture [108 x 54] intentionally omitted <==
----- Start of picture text -----
US PATIENTS
(PRIOR)
146,000
----- End of picture text -----
==> picture [107 x 231] intentionally omitted <==
----- Start of picture text -----
(1) 55,000
(2) 52,000
(3) 22,000
(4) 17,000
USD $575M
USD $900M
----- End of picture text -----
==> picture [100 x 56] intentionally omitted <==
US PATIENTS (REVISED) 194,510[1]
==> picture [106 x 56] intentionally omitted <==
----- Start of picture text -----
(1) 57,000
----- End of picture text -----
==> picture [106 x 180] intentionally omitted <==
----- Start of picture text -----
(2) 74,000
(3) 35,000
(4) 28,000
USD $750M
----- End of picture text -----
USD $1.08B[3]
-
American Cancer Society (ACS). Cancer Facts & Figures 2021. Atlanta, GA: American Cancer Society; 2021.
-
EU countries included in MAA submission to Danish Medicines Authority on 30 April 2020.
-
Dollar ($) TAM values are management estimates based on ACS (US) and Globocan (EU) reported incidence x estimated unit cost per dose. Telix Pharmaceuticals Limited (ASX: TLX)
Commercial launch plans - US Commercial ramp up during Q1 2022
==> picture [100 x 56] intentionally omitted <==
Positioned to capture meaningful market share
- Access to ~90% of eligible PET sites
==> picture [402 x 241] intentionally omitted <==
-
Distribution network holds 60% market share of nuclear medicine market in the US
-
On-demand pharmacy-based production with a high yield product
-
Customer and patient scheduling flexibility
Market access strategy in place, commercial launch underway
-
Q1 focus on early adopters – imaging centers and veteran affairs
-
400 imaging centres pre-qualified
-
Telix + partners will have one of the largest commercial teams (including sales, market access, MSL) to service the US prostate imaging market
==> picture [124 x 119] intentionally omitted <==
==> picture [19 x 19] intentionally omitted <==
Telix / partner sites Current competitor sites (19 January 2022)
On track for reimbursement in H1 2022
==> picture [19 x 19] intentionally omitted <==
-
HCPCS[1] code expected 1 April 2022
-
Transitional Pass-Through (TPT)[2] status expected 1 July 2022
-
Healthcare Common Procedure Coding System
Telix Pharmaceuticals Limited (ASX: TLX)
PSMA-PET imaging emerging as standard of care in prostate cancer Inclusion in guidelines is driving clinical adoption and reimbursement
==> picture [100 x 56] intentionally omitted <==
-
National Comprehensive Cancer Network Guidelines® (NCCN Guidelines) include Ga-68 PSMA-11 PET/CT to be considered as an alternative to standard imaging of bone and soft tissue[1]
-
Conventional imaging no longer a necessary prerequisite to PSMA-PET
-
• Aligns with indication for detection of unfavourable intermediate, high and very high risk as well as recurrent prostate cancer
-
Society of Nuclear Medicine and Molecular Imaging (SNMMI) updated Appropriate Use Criteria (AUC) recognises higher accuracy in the initial staging evaluation[2]
==> picture [199 x 80] intentionally omitted <==
==> picture [168 x 95] intentionally omitted <==
- Two of the four main Radiology Benefit Managers (RBMs) - AIM Specialty Health[3] and NIA Magellan[4] – are now recommending PSMA-PET representing a significant portion of commercial payor (health insurance) reimbursement policies
==> picture [137 x 55] intentionally omitted <==
- NCCN® Prostate Cancer Guidelines Update, Version 1.2022 – 10/09/21
==> picture [199 x 36] intentionally omitted <==
-
SNMMI AUC for PSMA-PET Imaging: https://www.snmmi.org/ClinicalPractice/content.aspx?ItemNumber=38657
-
AIM Clinical Appropriateness Guidelines, Advanced Imaging. AUC: Oncologic Imaging (Effective 7/11/21).
-
National Imaging Associates Magellan Clinical Guidelines For Medical Necessity Review, Advanced Imaging Guideline (Effective 01/01/22)
Telix Pharmaceuticals Limited (ASX: TLX)
The NOBLE Registry (TLX599-CDx): Nobody left behind Improving access to PSMA imaging – beyond Illuccix
==> picture [100 x 56] intentionally omitted <==
==> picture [126 x 45] intentionally omitted <==
==> picture [114 x 57] intentionally omitted <==
-
Collaboration to investigate utility of[99m] Tc-iPSMA SPECT[1] imaging in prostate cancer
-
Global consortium of clinical sites and investigators with experience using[99m] Tc-iPSMA
==> picture [45 x 47] intentionally omitted <==
-
Geographic focus on developing markets or remote regions where access to PET imaging is limited[2]
-
Isotope ([99m] Tc) supply chain well established and inexpensive
-
Rapid expansion planned including APAC
-
Single photon emission computed tomography
-
Worldwide SPECT cameras outnumber PET by 4:1 (MEDraysintell 2021) Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [544 x 443] intentionally omitted <==
----- Start of picture text -----
Chair
Dr. Ryan
Yudistiro
Dr. Akintunde Indonesia
Orunmuyi
Nigeria
Peter Tually
Australia
Dr. Mike Sathekge
South Africa
26
1.
----- End of picture text -----
==> picture [100 x 56] intentionally omitted <==
==> picture [240 x 120] intentionally omitted <==
Telix Pharmaceuticals Limited (ASX: TLX)
Prostate cancer therapy assets overview Next-generation therapy to follow TLX591
-
Target: Prostate Specific Membrane Antigen (PSMA)
-
Indication: Prostate cancer
-
Clinical status:
-
TLX591: ProstACT GLOBAL Phase III + ancillary studies recruiting
-
TLX592: CUPID study enrolling patients for imaging initially – next-generation PSMA-directed alpha therapy
-
Rationale:
-
Unmet need for treatment options for late-stage, metastatic patients specifically target both soft tissue and bony lesions
-
Antibody-based PSMA treatment may deliver superior efficacy and side-effect profile compared to small molecule
==> picture [100 x 56] intentionally omitted <==
| Target: PSMA | TLX591 | TLX592 |
|---|---|---|
| Targeting molecule |
Antibody | Engineered Antibody |
| Targeting agent | DOTA- rosopatamab |
RADmAb® |
| Radionuclide | 177Lu | 225Ac |
- TLX592 a potential adjuvant for high-risk patients that may have early metastatic disease. May also have utility in patients progressing from conventional[177] Lu-PSMA Tx
Telix Pharmaceuticals Limited (ASX: TLX)
ProstACT program overview Multiple opportunities to deliver insights into TLX591
==> picture [221 x 69] intentionally omitted <==
Radiogenomics study
-
~50 patients
-
1st line metastatic prostate cancer (mCRPC)
Treat the scan
- Rapid recruitment
Correlation between imaging and therapy to optimise patient selection
Combination with EBRT in oligometastatic early recurrence (Phase II)
==> picture [314 x 70] intentionally omitted <==
-
~50 patients
-
Co-funded by GenesisCare
Early data in front line care
Efficacy data in patients in their first recurrence
==> picture [428 x 69] intentionally omitted <==
Pivotal Phase III study in patients with mCRPC progressing on 1st line novel androgen agents
-
390 patients
-
• 2nd line mCRPC
TLX591 + Standard of Care (SoC) vs. SoC alone
==> picture [100 x 56] intentionally omitted <==
SELECT (Ph I) – radiogenomics study enhances patient selection and supports indication expansion based on a “theranostic” approach
– TARGET (Ph II) in partnership with GenesisCare, evaluates TLX591 in a front-line setting
GLOBAL (Ph III) – Multiple data read-outs throughout the ProstACT program duration
Telix Pharmaceuticals Limited (ASX: TLX)
ProstACT GLOBAL Phase III study Pivotal trial
==> picture [100 x 56] intentionally omitted <==
==> picture [116 x 39] intentionally omitted <==
TLX591 + Standard of Care (SoC) vs. SoC alone
Eligible Patients
-
PSMA avid (defined by TLX591-CDx)
-
mCRPC[1]
-
Progressed despite prior therapy with NAAD[2]
==> picture [55 x 38] intentionally omitted <==
TLX591 + Standard of care therapy Standard of care therapy alone
==> picture [136 x 108] intentionally omitted <==
-
International, multi-centre, Phase III RCT in ~390 patients with PSMA-expressing metastatic prostate cancer (mCRPC), experiencing disease progression following prior treatment with an anti-androgen drug (NAAD)
-
Primary endpoint: radiographic progression-free survival (rPFS)
-
Secondary endpoints include: overall survival, quality of life, safety
-
2:1 randomisation and enrichment of study population, patient selection with TLX591-CDx
-
Status: ProstACT GLOBAL has been initiated in Australia and will add EU, US and potentially Chinese sites over the next six months, subject to satisfying the requisite regulator approvals
-
Metastatic castrate-resistant prostate cancer
-
Novel androgen axis drug
Telix Pharmaceuticals Limited (ASX: TLX)
ProstACT SELECT Phase I study
Enhances patient selection and supports indication expansion
==> picture [100 x 56] intentionally omitted <==
==> picture [116 x 39] intentionally omitted <==
Treat the scan
Correlation between imaging and therapy to optimise patient selection
Eligible Patients
-
PSMA avid (defined by TLX591-CDx)
-
mCRPC
-
Progressed despite prior therapy with NAAD
==> picture [55 x 38] intentionally omitted <==
TLX591 + Standard of care therapy Comparative imaging between[68] Ga-PSMA and 177Lu -PSMA
==> picture [136 x 108] intentionally omitted <==
-
Ph I study of TLX591 for the treatment of mCRPC
-
Multi-centre, multinational Phase I radiogenomics study in Australia and New Zealand in ~50 patients, comparing 68Ga-PSMA and 177Lu-PSMA, specifically confirming the similarity of small molecule and antibody-based targeting
-
Radiogenomics study to enhance patient selection for ProstACT GLOBAL and support indication expansion for Telix’s PSMA therapeutic portfolio, based on a “theranostic” approach
-
Primary endpoints: biodistribution, safety and tolerability
-
Secondary endpoints include: correlation between imaging and therapy molecules, radiographic progression-free survival, PSA response
-
Status: Actively recruiting (screening patients)
Telix Pharmaceuticals Limited (ASX: TLX)
ProstACT TARGET Phase II study
Expanding clinical data to include a front-line setting
==> picture [100 x 56] intentionally omitted <==
==> picture [116 x 39] intentionally omitted <==
Early data in front line care Efficacy data in patients in their first recurrence
Eligible Patients
==> picture [55 x 38] intentionally omitted <==
-
PSMA avid (defined by TLX591-CDx)
-
Oligometastatic early recurrence
==> picture [201 x 70] intentionally omitted <==
----- Start of picture text -----
TLX591 + External Beam
Radiation Therapy
(EBRT)
----- End of picture text -----
In partnership with:
==> picture [122 x 25] intentionally omitted <==
==> picture [136 x 108] intentionally omitted <==
-
Single arm Phase II study in Australia in 50 patients with PSMA-expressing biochemically recurrent oligometastatic prostate cancer, in combination with external beam radiation therapy (EBRT)
-
To determine the efficacy, biodistribution and combination dosimetry of TLX591 plus EBRT, including dose to tumour
-
Primary endpoint: radiographic progression-free survival
-
Secondary endpoints include: overall survival, quality of life, safety
-
Status: Patient screening to commence early 2022 (subject to ethics approval)
Telix Pharmaceuticals Limited (ASX: TLX)
TLX591 differentiation Potential advantages with PSMA antibody approach
==> picture [100 x 56] intentionally omitted <==
==> picture [43 x 42] intentionally omitted <==
==> picture [42 x 42] intentionally omitted <==
==> picture [43 x 43] intentionally omitted <==
==> picture [46 x 46] intentionally omitted <==
Potential for improved overall survival (OS) in advanced metastatic disease, with 40+ months OS reported to date[[1 ]]
Efficacy 40+ months OS reported to date[[1 ]] Reduced potential for off-target side-effects: dry eye, xerostomia (salivary gland Patient comfort ablation), back pain (ganglia irradiation) Patient-centric Short treatment duration/significantly fewer hospital visits – two weeks total regimen vs. 36 weeks, supports close supervision by medical oncology Significantly lower[177] Lu isotope requirements with commensurate reduction in Cost effective COGS, expected to also be available in “cold kit” format
- Tagawa et al, Cancer 2019.
Telix Pharmaceuticals Limited (ASX: TLX)
TLX591 patient experience Off-target irradiation – quality of life matters
==> picture [167 x 337] intentionally omitted <==
==> picture [179 x 337] intentionally omitted <==
TLX591
Antibodies are functionally specific for tumour-expressed PSMA and do not “hit” most endogenous PSMA expression
Liver (preferred clearance organ)
Fecal excretion
Lacrimal, Parotid, Submandibular (salivary) glands
Spleen, Liver
Kidneys, Small bowel
Bladder
(urinary excretion)
==> picture [100 x 56] intentionally omitted <==
Small molecule
Small molecule radioligands taken up by endogenous PSMA
Additional off-target effects with small molecule radioligands (not experienced with TLX591):
-
Dry eye
-
Xerostomia
-
Back pain from ganglia irradiation
Data courtesy of Prof. Neil Bander, WCMC.
Telix Pharmaceuticals Limited (ASX: TLX)
Our long-term vision for prostate cancer Improving access, imaging and treatment options for patients
==> picture [100 x 56] intentionally omitted <==
-
Further development of the PSMA target underpins our lifecycle management strategy for prostate cancer and vision to improve patient outcomes
-
PSMA pipeline includes imaging, therapy and surgical tools
-
NOBLE Registry (PSMA-SPECT tracer): TLX599-CDx ([99m] Tc-iPSMA) – PSMA imaging access for patients in developing and remote areas, where PET is not readily available
-
Next-generation alpha therapy: TLX592 ([225] AcRADmAb®) – high potency, complementary to TLX591
-
Image guided surgery: TLX591-Sx ([68] Ga-PSMA-IRDye) - dual-labelled PET-optical tracer for image guided surgery, enables real-time cancer detection[1]
-
Imaging and Robotics in Surgery Alliance with Mauna Kea Technologies.
Telix Pharmaceuticals Limited (ASX: TLX)
Our clinical mission: support the patient every step of the way
==> picture [100 x 56] intentionally omitted <==
Localised disease
Radiation therapy +/- ADT Radical prostatectomy PSA Active surveillance
level
Advancing clinical stages Docetaxel, abiraterone (metastatic, non-castrate), apalutamide, enzalutamide, darolutamide (non-metastatic, castrate resistant)
Metastatic castrate resistant
First line:
Docetaxel; Sipuleucel-T; Abiraterone Enzalutamide
==> picture [100 x 33] intentionally omitted <==
PSMA-617 failures
68Ga / 99mTc imaging
==> picture [117 x 39] intentionally omitted <==
==> picture [89 x 47] intentionally omitted <==
----- Start of picture text -----
Asymptomatic
Non-metastatic
Castration-sensitive
----- End of picture text -----
==> picture [663 x 214] intentionally omitted <==
----- Start of picture text -----
Rising PSA
Radiogenomics and
ADT (non-castrate)
tumour targeting of
TLX591
Combination of EBRT
and TLX591 in early
biochemical recurrence Second line +
Clinical trial
Second line:
Cabazitaxel; Abiraterone
TLX592 ( [225] Ac)
Enzalutamide; Radium 223
Olaparib; Rucaparib
Pivotal Phase III study in patients with
mCRPC progressing on 1st line novel
androgen agents
----- End of picture text -----
==> picture [87 x 47] intentionally omitted <==
----- Start of picture text -----
Symptomatic
Metastatic
Castration-resistant
----- End of picture text -----
Time / disease progression
Telix Pharmaceuticals Limited (ASX: TLX)
CUPID trial
- Next neration al ha ther com lements TLX591 ge p apy, p
==> picture [100 x 56] intentionally omitted <==
Study with[64] Cu-TLX592 to show biodistribution and tumour targeting prior to targeted alpha therapy (TAT) with[225] Ac-TLX592
==> picture [115 x 34] intentionally omitted <==
-
Eligible Patients
-
• Prostate cancer patients with low-burden metastatic disease at ≤ 5 sites as detected using PSMA PET/CT scanning (TLX591-CDx)
225Ac-TLX592 64Cu-TLX592 TAT PET/CT scan Subject to positive outcomes with[64] Cu
==> picture [136 x 108] intentionally omitted <==
-
TAT is becoming an important area of PSMA therapy research, particularly in men that are no longer responding to[177] Lu
-
TLX592 antibody re-engineered to clear ~10x faster from the body, while maintaining specificity for tumour-expressed PSMA (liver cleared, no exocrine uptake)
-
Designed for delivering TAT ([225] Ac) intended for:
-
Early-stage metastatic disease (e.g. biochemical recurrence (BCR))
-
Late-stage disease when[177] Lu-PSMA therapy is no longer providing treatment efficacy
-
Single arm, open-label, first-in-human (FIH) study of[64] Cu-TLX592 in men with metastatic prostate cancer using PET
-
Primary endpoint: Determine the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation dosimetry of[64] Cu-TLX592 using PET as a proxy for[225] Ac-TLX592 TAT
-
Status: Actively recruiting – multiple patients dosed in imaging phase
Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [153 x 44] intentionally omitted <==
==> picture [160 x 56] intentionally omitted <==
==> picture [100 x 56] intentionally omitted <==
Telix Pharmaceuticals Limited (ASX: TLX)
TLX250-CDx / TLX250 overview An exciting target, with potential application beyond kidney cancer
==> picture [100 x 56] intentionally omitted <==
-
Target: Carbonic Anhydrase IX (CAIX / CA9)
-
Indication: Kidney cancer (clear cell renal cell carcinoma, ccRCC)
-
Development status:
-
TLX 250-CDx: Phase III ZIRCON diagnostic imaging study nearing completion
-
TLX250: Phase II STARLITE 1 & 2 therapeutic studies (in combination with immunotherapy) initiated
-
• Rationale:
-
CA9 is over-expressed in mutated ccRCC and many hypoxic solid tumors, with low expression in most normal tissue
==> picture [339 x 272] intentionally omitted <==
----- Start of picture text -----
Target: Dx Tx
CAIX / CA9 (TLX250-CDx) (TLX250)
Targeting
Antibody Antibody
molecule
Targeting DFO- DOTA-
agent girentuximab girentuximab
Radionuclide 89Zr 177Lu
----- End of picture text -----
-
Tumour hypoxia correlates with progression and resistance to therapy
-
Potential for targeted radiation to enhance the effect of existing ccRCC therapies such as immunotherapy
-
Limited competition in imaging, optimises surgical management
Telix Pharmaceuticals Limited (ASX: TLX)
Building a high-value diagnostics portfolio “Breakthrough Therapy” designation, clinical leadership opportunity
==> picture [100 x 56] intentionally omitted <==
-
Biologics License Application (BLA) consultation process has commenced, Phase III study in final stages of enrolment
-
TLX250-CDx is an investigational product being developed for the imaging of clear cell renal cell carcinoma (ccRCC) with PET/CT
-
Current options for patients are limited, potential for clinical leadership with a non-invasive imaging modality for ccRCC
-
Being studied as an imaging agent assessing ability to determine if “indeterminate renal masses” are malignant through improved, whole of body imaging
-
May aid decision making and avoid unnecessary surgical intervention
-
Opportunity to follow prostate cancer imaging, with a second high-value product for the genitourinary (GU) oncology field
==> picture [241 x 250] intentionally omitted <==
An example of PET/CT imaging showing the uptake of 89Zr-girentuximab in a primary renal mass. The insert shows the identification of a metastatic lesion of the proximal radius, confirmed as ccRCC upon biopsy.[1]
- Hekman et al, European Urology. 2018.
Telix Pharmaceuticals Limited (ASX: TLX)
TLX250-CDx: delivering an unmet need in kidney cancer imaging
==> picture [100 x 56] intentionally omitted <==
-
Total addressable market value in US and Europe estimated at US$300-400M[1]
-
Potential for market leadership, given limited patient options
-
Addresses a major unmet medical need for more accurate patient staging
==> picture [689 x 389] intentionally omitted <==
----- Start of picture text -----
Yearly estimated
Yearly new cases,
number of deaths,
worldwide, both
worldwide, both
sexes, all ages
sexes, all ages
431,288
179,368
----- End of picture text -----
- Management estimate based on Globocan reported incidence; (Globocan 2020)
Dollar ($) TAM values are management estimates based on Globocan reported incidence x estimated unit cost per dose. Telix Pharmaceuticals Limited (ASX: TLX)
ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC Study overview
==> picture [100 x 56] intentionally omitted <==
==> picture [133 x 39] intentionally omitted <==
Eligible Patients
-
Single indeterminate renal mass ≤7cm diameter on CT or MRI suspicious for ccRCC
-
• Scheduled for surgical removal as part of management plan
==> picture [325 x 118] intentionally omitted <==
----- Start of picture text -----
Surgical removal
TLX250-CDx
and histology as
PET/CT scan
standard of truth
----- End of picture text -----
==> picture [154 x 117] intentionally omitted <==
-
International, multi-centre, Phase III trial in ~252 patients with an indeterminate renal mass suspicious of ccRCC
-
Primary endpoint: Sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth (after surgical removal)
-
35 sites participating
-
85% recruited, progressing well towards completion
-
United States, Canada, Europe, Turkey, Australia
-
ZIRDAC-JP Phase I/II bridging trial of TLX250-CDx in Japan
-
Phase I objectives met, Phase II in planning, potential to include Chinese patients to expand Asian utility
Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [100 x 56] intentionally omitted <==
STARLITE 2 Phase II trial of TLX250 for treatment of ccRCC TLX250 in combination with immunotherapy
==> picture [281 x 352] intentionally omitted <==
-
STARLITE 2 now actively recruiting (screening patients)
-
Phase II trial of TLX250 plus nivolumab with ccRCC who have progressed following prior immunotherapy
-
NCT03849118 Evaluates TLX250-delivered radiation as an immune system “primer”
-
NCT03849118
-
Targets carbonic anhydrase IX (CA9) – a protein highly expressed in patients that are likely to demonstrate a more limited response to cancer immunotherapy
-
Primary endpoint
-
To determine the safety and efficacy of combination therapy with 177Lugirentuximab (TLX250) FDA Investigational New Drug Application (IND) accepted for STARLITE 2 study, being undertaken at Memorial Sloan Kettering Cancer Centre
-
Additional Phase II study – STARLITE 1 - (first-line combination study) to be initiated at a second US site (awaiting ethics approval)
-
Giatromanolaki et al. British Journal of Cancer . 2020.
CA9 expression is correlated with the presence of tumour-infiltrating lymphocytes, which may confer resistance to immunotherapy.[1]
43
Telix Pharmaceuticals Limited (ASX: TLX)
CA9 indication expansion
New understanding leads to potential for applications beyond kidney cancer
==> picture [100 x 56] intentionally omitted <==
-
A transmembrane protein and a tumor-associated carbonic anhydrase isoenzyme
-
Over-expressed in mutated ccRCC and many hypoxic solid tumors, with low expression in most normal tissue
-
High expression in tumours including bladder or urothelial, breast, brain, cervix, colon, esophagus, head and neck, lung, ovarian, pancreatic and vulval cancers
-
Imaging is being used to “indication scout” for future therapy applications, highlight the value of a “theranostic” approach
| Potential | Indication | Status |
|---|---|---|
| Bladder or Urothelial Cancer | Commenced | |
| Triple Negative Breast Cancer | Commenced | |
| Lung Cancer | Planned | |
| Ovarian Cancer | Planned | |
| Colorectal Cancer | Planned | |
| Head and Neck Cancer | Planned | |
| Pancreatic Cancer | Planned |
Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [100 x 56] intentionally omitted <==
Telix Pharmaceuticals Limited (ASX: TLX)
TLX101-CDx / TLX101 overview
Orphan designation status granted for imaging and therapy candidates
==> picture [100 x 56] intentionally omitted <==
-
Target: Large amino acid transporter 1 (LAT-1)
-
• Indication: Glioblastoma multiforme (GBM)
-
Clinical status:
-
TLX101-CDx: Progressing towards new drug application (NDA) filing in 2022
-
TLX101: IPAX-2 follow-on Phase I/II study in newly diagnosed patients commencing in 2022
-
Rationale:
-
TLX101-CDx: FET-PET demonstrated to provide greater diagnostic sensitivity compared to standard imaging procedures
Dx Tx Target: LAT-1 (TLX101(TLX101) CDx) Targeting molecule Small molecule Small molecule Fluoroethyl)-L4-L-[[131] I] Iodo- Targeting agent tyrosine (FET) Phenylalanine Radionuclide 18F 131I
- TLX101: Poor prognosis with few treatment options. Promising overall survival data in IPAX-1 study warrants further investigation in earlier stage patients
Telix Pharmaceuticals Limited (ASX: TLX)
IPAX-I Phase I/II trial of TLX101 for the treatment of GBM[1]
==> picture [100 x 56] intentionally omitted <==
TLX101 in combination with EBRT[2]
-
Multi-centre Phase I/II trial of TLX101 in combination with EBRT in patients with recurrent GBM
-
Primary endpoint: Safety and tolerability
-
Secondary endpoints include: MTD[3] , efficacy, dosimetry
-
NCT03849118
-
NCT03849118 • First-peer review data presented at Congress of Neurological Surgeons (CNS) Annual Meeting in October 2021
-
All patients evaluated received similar total activity dose of ~2GBq (2000 MBq) of TLX101, either in a single administration or a triple-fractionated regime.
-
Treatment well tolerated, typically grade 1 – 2 adverse events
-
Evidence of anti-tumour effect from both imaging and clinical assessment
-
Overall survival (OS) on this interim analysis shows median 15.97 months to date
-
6/10 patients still alive and will be followed until 1 year after dosing for the final OS calculation (May 2022)
.
-
Glioblastoma Multiforme.
-
Maximum tolerated dose.
==> picture [160 x 162] intentionally omitted <==
Baseline PET scan
==> picture [161 x 162] intentionally omitted <==
Day 45 PET scan post TLX101 therapy
- External beam radiation therapy Telix Pharmaceuticals Limited (ASX: TLX)
Building on the IPAX-1 experience IPAX-2 will evaluate TLX101 in newly-diagnosed patients
==> picture [100 x 56] intentionally omitted <==
==> picture [371 x 372] intentionally omitted <==
-
Progression of TLX101 program into front-line setting, Phase I/II study expected to commence in Q1 2022
-
Initial dose finding study TLX101 plus standard of care (SOC) in patients with
-
NCT03849118 newly diagnosed glioblastoma, after surgery
-
NCT03849118
-
Evaluates the potential for DNA damage from targeted radiation using TLX101 to enhance SOC radio-chemotherapy for newly diagnosed glioma
-
Study objectives expected to include:
-
Maximum tolerated dose
-
Safety and tolerability in combination with the Stupp regimen (SOC)
-
12 months overall survival rates
-
Progression free survival at a range of treatment intervals
-
Single-arm, multi-centre trial, expected to enrol 12-15 patients in Phase I
-
Patients to be treated and monitored for up to 64 weeks
Telix Pharmaceuticals Limited (ASX: TLX)
TLX66 CDx / TLX66 overview
Application across a range of conditions requiring bone marrow conditioning
==> picture [100 x 56] intentionally omitted <==
-
Target: CD66 (Cluster of differentiation 66)
-
Indication: • TLX66-CDx: Scintigraphic bone imaging
-
TLX66: Bone marrow conditioning for systemic amyloid light chain amyloidosis
-
Development status:
-
TLX66-CDx (Scintimun®): Approved in EU
-
TLX66: Phase I TRALA study completed in 2021, planning for Phase II study in progress
-
• Rationale:
-
TLX66-CDx: Lower cost, faster than white blood cell labelling (current standard). Data from >100,000 patients in Europe to support regulatory filing in US
| Target: CD66 | Dx (TLX66- CDx) |
Tx (TLX66) |
|---|---|---|
| Targeting molecule | Antibody | Antibody |
| Targeting agent | besilesomab | DTPA- besilesomab |
| Radionuclide | 99mTc | 90Y |
- TLX66: Significantly reduced toxicity and tolerability compared to chemo-ablative approaches, potential to treat patients ineligible for SoC (e.g., older patients, co-morbidities, children)
Telix Pharmaceuticals Limited (ASX: TLX)
New hope in a rare disease Progressing development of TLX66 in bone marrow conditioning
-
SALA[1] is a rare disease with a poor prognosis (median survival ~11 months if untreated)
-
Plasma cells in the bone marrow produce abnormal protein called ‘amyloid’ which accumulates in the organs and causes them to fail
-
NCT03849118
-
NCT03849118 Prevalence of ~30,000 to 45,000 (US + EU combined) patients, ~US$600M[2] TAM in US and ‘EU5’
-
Current standard of care comprises induction therapy (cyclophosphamide, bortezomib, dexamethasone) plus high dose melphalan BMC[3] , followed by HSCT[4, 5]
-
A novel monoclonal antibody, daratumumab has potential as an initial therapy for patients but is not curative or suitable for all patient populations
-
TRALA study: Phase I trial of[90] Y-besilesomab (TLX66) in SALA
-
Primary endpoint: Safety and toxicity of[90] Y-besilesomab as the sole BMC regimen for autologous HSCT in patients with SALA
-
Study complete, preliminary data (9 pts) demonstrated 100% engraftment and high PR/CR rate (5/2) survival data. Regulator consultation in progress for next phase of development
1. Systemic amyloid light chain amyloidosis.
Management estimate based on reported incidence x estimated unit dosing price, based on prevalence of 12M persons per year (Monique Minnema and Stefan Schönland, The EBMT Handbook: Hematopoietic Stem Cell Transplantation and Cellular Therapies, 2019)
-
Bone marrow conditioning.
-
Hematopoietic stem cell transplant.
-
Venner C, et al. Blood. (2012) 119 (19): 4387–4390.
-
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002231-18/GB
==> picture [100 x 56] intentionally omitted <==
==> picture [72 x 105] intentionally omitted <==
Faulty plasma cells
==> picture [32 x 243] intentionally omitted <==
==> picture [78 x 26] intentionally omitted <==
----- Start of picture text -----
Free antibody
light chain
----- End of picture text -----
==> picture [72 x 56] intentionally omitted <==
----- Start of picture text -----
Amyloid
protein
accumulates
in organs
----- End of picture text -----
Organ failure, death
Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [100 x 56] intentionally omitted <==
Future value creation Focus on innovation and growth markets
51
Telix Pharmaceuticals Limited (ASX: TLX)
Near-term growth opportunities Expansion into new geographic markets
==> picture [100 x 56] intentionally omitted <==
==> picture [86 x 86] intentionally omitted <==
-
China Grand Pharma partnership
-
NMPA consultations have commenced (Mainland China)
-
Regulatory filings for Illuccix Q1 2022 (Taiwan, Hong Kong)
==> picture [86 x 86] intentionally omitted <==
-
Launch Illuccix with distribution partner (in progress)
-
NOBLE Registry expansion
-
National Evidence-based Healthcare Collaborating Agency. Health Technology Assessment.
==> picture [86 x 86] intentionally omitted <==
-
DuChemBio partnership
-
NECA HTA[1] completed
• Illuccix kit sales have commenced, pursuing reimbursement under local regulatory exemption
- Largest Asia Pacific market opportunity
Key bridging clinical trials have been successfully completed (TLX591-CDx & TLX250-CDx)
Telix Pharmaceuticals Limited (ASX: TLX)
Buildout of the Brussels (Seneffe) manufacturing facility Vertical integration in Europe
==> picture [100 x 56] intentionally omitted <==
-
Seneffe will serve as the primary EU manufacturing site for Telix’s products
-
Will also be used to manufacture[131] I-based products for export
-
NCT03849118
-
NCT03849118 (i.e. TLX101) using Belgian-sourced isotopes (Belgium is a major global supplier)
-
Provides certainty / control over supply chain
-
Seneffe will be an integral part of Telix’s EU R&D capability
-
Enables the capture of intellectual property that is intrinsic in manufacturing scale-up of this class of products
-
First legacy cyclotron removed October 2021, second in November 2021
-
New buildout has commenced
==> picture [404 x 302] intentionally omitted <==
Telix Pharmaceuticals Limited (ASX: TLX)
Future research and innovation focus
==> picture [104 x 58] intentionally omitted <==
==> picture [145 x 144] intentionally omitted <==
==> picture [179 x 179] intentionally omitted <==
==> picture [178 x 179] intentionally omitted <==
==> picture [144 x 144] intentionally omitted <==
==> picture [145 x 144] intentionally omitted <==
Targeted alpha MTR[1] + 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 clinical imaging into the cancer treatments for alpha-emitting insights gained from operating room (OR) improved efficacy with radioisotopes immuno-therapy in imaging, link to biomarker-driven combination therapeutic outcomes patient selection
- Molecularly targeted radiation Telix Pharmaceuticals Limited (ASX: TLX)
54
==> picture [100 x 56] intentionally omitted <==
Key risks
55
Telix Pharmaceuticals Limited (ASX: TLX)
Key risks
==> picture [100 x 56] intentionally omitted <==
- Pricing : There is no guarantee that the Company’s products will obtain anticipated selling prices or reimbursement levels, which may impact profitability and marketability of the products.
Commercial
Competition : Telix’s industry is highly competitive. Many competitors have greater resources to invest including into product development and brand recognition.
• Supply Chain : Telix depends on third parties for the supply of critical materials for the manufacture of products, highly-specialised manufacturing of products, and the distribution of products once manufactured. Telix may experience disruptions to its supply chain, such as: a shortage of raw materials; lack of capacity by Telix’s key manufacturers to provide the required services during appropriate timeframes; manufacturing quality risks; disruptions associated with distribution and logistics; labour shortages; and an inability to pass on increased costs of any of the above.
Financial : Proceeds from the Offer may be insufficient for the Company to reach financial self-sustainability if sales are lower than anticipated over the long term. As a result, Telix may need to raise further capital through equity financing or other means.
Corporate
Key Person(s) : Telix’s ability to execute its business plan is highly dependent upon the efforts and abilities of a number of key staff. Telix seeks to maintain high retention rates through the establishment of a high-quality working environment, competitive salary packages including STI / LTI components and performance benchmarking, however, this may not be sufficient to attract and maintain the required skilled workforce.
Foreign Exchange : The Group conducts certain clinical and regulatory activities internationally, and accordingly has foreign currency liabilities in Euro (EUR) and United States Dollars (USD), giving rise to a currency and foreign exchange risk. The Group maintains foreign currency bank accounts denominated in USD in order to minimise this risk.
-
Clinical and • Regulatory
Regulatory Approvals : The Company will need approvals from the US FDA and European EMA to commercialise and market approved products, as well as equivalent regulatory authorities in other foreign jurisdictions to commercialise in those regions. The Company may not receive the necessary regulatory approvals for any given product.
Regulatory Compliance : Telix is required to comply with a broad range of legal and regulatory requirements (including competition law, anti-bribery, GDPR and privacy laws). Telix has implemented a commercial compliance system to ensure its regulatory compliance. However, global regulation is multi-disciplinary and complex and there is a risk that Telix may breach or fail to meet one or more of its compliance and regulatory obligations.
Clinical Trials : Each clinical development phase has a distinct and significant risk of failure or delay, including not meeting clinical endpoints or delay from extrinsic factors.
-
IP / Licensing •
Licensors : Most of Telix’s products are being developed under license. These licenses come with performance conditions attached which may be triggered if Telix fails to meet particular milestones. Telix may also encounter potential challenges if a licensor attempts to terminate a licence or enters insolvency.
Intellectual Property : The Company’s success will depend partly on its ability to obtain and maintain commercially useful patent claims for its products. Telix seeks to utilise effective advisory, in-house IP management resources and an internal technical team to effectively manage its product IP, however, any failings with this system may have a detrimental impact on the Company.
Telix Pharmaceuticals Limited (ASX: TLX)
Key risks
Operations
==> picture [100 x 56] intentionally omitted <==
• Quality Assurance : Telix operates in a complex, highly regulated environment relating to the manufacture and supply of medical treatments for humans. Telix has implemented a Quality Management System (QMS) which is paramount to ensuring patient safety, however, for issued product that is not in line with Telix and global specifications, Telix may incur liabilities such as product recall obligations. • IT and Infrastructure : TLX remains open to threats of cyber-attack, data theft and data loss.
• Seneffe decommissioning and buildout : Telix has decommissioned two cyclotrons from a brownfield site in Belgium and is installing a new cyclotron as it plans for operations at ‘Telix Manufacturing Solutions’. This will require significant management time from Telix as it establishes appropriate monitoring, training and review processes to ensure that this decommissioning and construction is completed in accordance with all applicable laws and regulations, including any environmental laws.
Environmental
• Environmental safety : There is a risk associated with the production, transportation and storage of radiopharmaceutical products. In the event that there is environmental damage arising from an issue with such products, Telix may incur significant costs in mitigation and remediation of such damage. Telix seeks to use qualified suppliers for the transport of product and materials, and provide comprehensive employee training regarding these risks, however, this may not be sufficient to prevent such incidents from occurring.
-
As a result of the COVID-19 pandemic, Telix may experience further disruptions that could potentially lead to additional delays in accomplishing key business objectives. Key risks include:
-
Impact on supply chain – including CMOs whose facilities are seconded for vaccine and therapy manufacturing; and transport / logistics with border restrictions across and within country borders.
-
Impact on manufacturing capacity – worldwide distribution issues may have a negative impact on operations in biologics, radiochemistry and fill finish.
COVID-19
-
Impact on clinical trials – Telix may face difficulties recruiting clinical trial participants in the context of COVID-19, in particular due to the vulnerable nature of Telix’s targeted participants. There may also be disruptions to clinical trials due to health care facilities prioritising management and treatment of COVID-19 patients, and unavailability of staff due to COVID-19 infection or isolation requirements.
-
Impact on regulatory reviews – Government-mandated isolation and/or border control policies may impact Telix employees and/or employees of regulatory agencies. Reductions in workforce availability may impact the timing for the submission and/or review of regulatory applications. Such delays may further impact timing for future approval decisions and/or commercialisation of associated products.
-
Impact on workplace morale: Telix has a strong focus on culture, values and workplace health and safety, and has number of wellbeing initiatives in place to seek to address existing and potential future impacts of the pandemic. Those initiatives may not all be successful and Telix may experience loss of key staff and/or reduced workforce capacity.
Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [100 x 56] intentionally omitted <==
International offer restrictions
58
Telix Pharmaceuticals Limited (ASX: TLX)
International offer restrictions (1/3)
==> picture [100 x 56] intentionally omitted <==
This document does not constitute an offer of Shares of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the Shares may not be offered or sold, in any country outside Australia except to the extent permitted below.
Canada (British Columbia, Ontario and Quebec provinces)
This document constitutes an offering of Shares only in the Provinces of British Columbia, Ontario and Quebec (the "Provinces"), only to persons to whom Shares may be lawfully distributed in the Provinces, and only by persons permitted to sell such securities. This document is not a prospectus, an advertisement or a public offering of securities in the Provinces. This document may only be distributed in the Provinces to persons who are "accredited investors" within the meaning of National Instrument 45-106 – Prospectus Exemptions , of the Canadian Securities Administrators.
No securities commission or authority in the Provinces has reviewed or in any way passed upon this document, the merits of the Shares or the offering of the Shares and any representation to the contrary is an offence.
No prospectus has been, or will be, filed in the Provinces with respect to the offering of Shares or the resale of such securities. Any person in the Provinces lawfully participating in the offer will not receive the information, legal rights or protections
that would be afforded had a prospectus been filed and receipted by the securities regulator in the applicable Province. Furthermore, any resale of the Shares in the Provinces must be made in accordance with applicable Canadian securities laws. While such resale restrictions generally do not apply to a first trade in a security of a foreign, non-Canadian reporting issuer that is made through an exchange or market outside Canada, Canadian purchasers should seek legal advice prior to any resale of the Shares.
The Company as well as its directors and officers may be located outside Canada and, as a result, it may not be possible for purchasers to effect service of process within Canada upon the Company or its directors or officers. All or a substantial portion of the assets of the Company and such persons may be located outside Canada and, as a result, it may not be possible to satisfy a judgment against the Company or such persons in Canada or to enforce a judgment obtained in Canadian courts against the Company or such persons outside Canada.
Any financial information contained in this document has been prepared in accordance with Australian Accounting Standards and also comply with International Financial Reporting Standards and interpretations issued by the International Accounting Standards Board. Unless stated otherwise, all dollar amounts contained in this document are in Australian dollars.
Statutory rights of action for damages and rescission. Securities legislation in certain Provinces may provide a purchaser with remedies for rescission or damages if an offering memorandum contains a misrepresentation, provided the remedies for
rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s Province. A purchaser may refer to any applicable provision of the securities legislation of the purchaser’s Province for particulars of these rights or consult with a legal adviser.
Certain Canadian income tax considerations. Prospective purchasers of the Shares should consult their own tax adviser with respect to any taxes payable in connection with the acquisition, holding or disposition of the Shares as there are Canadian tax implications for investors in the Provinces.
Language of documents in Canada. Upon receipt of this document, each investor in Canada hereby confirms that it has expressly requested that all documents evidencing or relating in any way to the sale of the Shares (including for greater certainty any purchase confirmation or any notice) be drawn up in the English language only. Par la réception de ce document, chaque investisseur canadien confirme par les présentes qu’il a expressément exigé que tous les documents faisant foi ou se rapportant de quelque manière que ce soit à la vente des valeurs mobilières décrites aux présentes (incluant, pour plus de certitude, toute confirmation d’achat ou tout avis) soient rédigés en anglais seulement.
European Union
This document has not been, and will not be, registered with or approved by any securities regulator in the European Union. Accordingly, this document may not be made available, nor may the Shares be offered for sale, in the European Union except in circumstances that do not require a prospectus under Article 1(4) of Regulation (EU) 2017/1129 of the European Parliament and the Council of the European Union (the "Prospectus Regulation").
In accordance with Article 1(4)(a) of the Prospectus Regulation, an offer of Shares in the European Union is limited to persons who are "qualified investors" (as defined in Article 2(e) of the Prospectus Regulation).
Hong Kong
WARNING: This document has not been, and will not be, registered as a prospectus under the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32) of Hong Kong, nor has it been authorised by the Securities and Futures Commission in Hong Kong pursuant to the Securities and Futures Ordinance (Cap. 571) of the Laws of Hong Kong (the "SFO"). Accordingly, this document may not be distributed, and the Shares may not be offered or sold, in Hong Kong other than to "professional investors" (as defined in the SFO and any rules made under that ordinance).
Telix Pharmaceuticals Limited (ASX: TLX)
International offer restrictions (2/3)
==> picture [100 x 56] intentionally omitted <==
Hong Kong (cntd)
No advertisement, invitation or document relating to the Shares has been or will be issued, or has been or will be in the possession of any person for the purpose of issue, in Hong Kong or elsewhere that is directed at, or the contents of which are likely to be accessed or read by, the public of Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to Shares that are or are intended to be disposed of only to persons outside Hong Kong or only to professional investors. No person allotted Shares may sell, or offer to sell, such securities in circumstances that amount to an offer to the public in Hong Kong within six months following the date of issue of such securities. The contents of this document have not been reviewed by any Hong Kong regulatory authority. You are advised to exercise caution in relation to the offer. If you are in doubt about any contents of this document, you should obtain independent professional advice.
Israel
The Shares have not been registered, and no prospectus will be issued, under the Israeli Securities Law, 1968 (the "Securities Law"). Accordingly, the Shares will only be offered and sold in Israel pursuant to private placement exemptions, namely to no more than 35 offerees who fall within a category of sophisticated investor as described in the First Addendum of the Securities Law.
Neither this document nor any activities related to the Offer shall be deemed to be the provision of investment advice. If any recipient of this document is not the intended recipient, such recipient should promptly return this document to the Company. This document has not been reviewed or approved by the Israeli Securities Authority in any way.
New Zealand
This document has not been registered, filed with or approved by any New Zealand regulatory authority under the Financial Markets Conduct Act 2013 (the "FMC Act").
The Shares are not being offered or sold in New Zealand (or allotted with a view to being offered for sale in New Zealand) other than to a person who:
-
is an investment business within the meaning of clause 37 of Schedule 1 of the FMC Act;
-
meets the investment activity criteria specified in clause 38 of Schedule 1 of the FMC Act;
-
is large within the meaning of clause 39 of Schedule 1 of the FMC Act;
-
is a government agency within the meaning of clause 40 of Schedule 1 of the FMC Act; or
-
is an eligible investor within the meaning of clause 41 of Schedule 1 of the FMC Act.
Norway
This document has not been approved by, or registered with, any Norwegian securities regulator under the Norwegian Securities Trading Act of 29 June 2007 no. 75. Accordingly, this document shall not be deemed to constitute an offer to the public in Norway within the meaning of the Norwegian Securities Trading Act. The Shares may not be offered or sold, directly or indirectly, in Norway except to "professional clients" (as defined in the Norwegian Securities Trading Act).
Singapore
This document and any other materials relating to the Shares have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore. Accordingly, this document and any other document or materials in connection with the offer or sale, or invitation for subscription or purchase, of Shares, may not be issued, circulated or distributed, nor may the Shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore except pursuant to and in accordance with exemptions in Subdivision (4) Division 1, Part XIII of the Securities and Futures Act, Chapter 289 of Singapore (the "SFA"), or as otherwise pursuant to, and in accordance with the conditions of any other applicable provisions of the SFA.
This document has been given to you on the basis that you are (i) an "institutional investor" (as defined in the SFA) or (ii) an "accredited investor" (as defined in the SFA). If you are not an investor falling within one of these categories, please return this document immediately. You may not forward or circulate this document to any other person in Singapore.
Any offer is not made to you with a view to the Shares being subsequently offered for sale to any other party. There are on-sale restrictions in Singapore that may be applicable to investors who acquire Shares. As such, investors are advised to acquaint themselves with the SFA provisions relating to resale restrictions in Singapore and comply accordingly.
Telix Pharmaceuticals Limited (ASX: TLX)
International offer restrictions (3/3)
==> picture [100 x 56] intentionally omitted <==
Switzerland
The Shares may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange or on any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering or marketing material relating to the Shares constitutes a prospectus or a similar notice, as such terms are understood under art. 35 of the Swiss Financial Services Act or the listing rules of any stock exchange or regulated trading facility in Switzerland. No offering or marketing material relating to the Shares has been, nor will be, filed with or approved by any Swiss regulatory authority or authorised review body. In particular, this document will not be filed with, and the offer of Shares will not be supervised by, the Swiss Financial Market Supervisory Authority (FINMA).
Neither this document nor any other offering or marketing material relating to the Shares may be publicly distributed or otherwise made publicly available in Switzerland. The Shares will only be offered to investors who qualify as "professional clients" (as defined in the Swiss Financial Services Act). This document is personal to the recipient and not for general circulation in Switzerland.
United Kingdom
Neither this document nor any other document relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Markets Act 2000, as amended ("FSMA")) has been published or is intended to be published in respect of the Shares.
The Shares may not be offered or sold in the United Kingdom by means of this document or any other document, except in circumstances that do not require the publication of a prospectus under section 86(1) of the FSMA. This document is issued on a confidential basis in the United Kingdom to "qualified investors" within the meaning of Article 2(e) of the UK Prospectus Regulation. This document may not be distributed or reproduced, in whole or in part, nor may its contents be disclosed by recipients, to any other person in the United Kingdom.
Any invitation or inducement to engage in investment activity (within the meaning of section 21 of the FSMA) received in connection with the issue or sale of the Shares has only been communicated or caused to be communicated and will only be communicated or caused to be communicated in the United Kingdom in circumstances in which section 21(1) of the FSMA does not apply to the Company.
In the United Kingdom, this document is being distributed only to, and is directed at, persons (i) who have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005 ("FPO"), (ii) who fall within the categories of persons referred to in Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the FPO or (iii) to whom it may otherwise be lawfully communicated (together "relevant persons"). The investment to which this document relates is available only to relevant persons. Any person who is not a relevant person should not act or rely on this document.
United States
This document does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States. The Shares have not been, and will not be, registered under the US Securities Act of 1933 or the securities laws of any state or other jurisdiction of the United States. Accordingly, the Shares may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the US Securities Act and applicable US state securities laws.
The Shares will only be offered and sold in the United States to:
-
“qualified institutional buyers” (as defined in Rule 144A under the US Securities Act); and
-
dealers or other professional fiduciaries organized or incorporated in the United States that are acting for a discretionary or similar account (other than an estate or trust) held for the benefit or account of persons that are not US persons and for which they exercise investment discretion, within the meaning of Rule 902(k)(2)(i) of Regulation S under the US Securities Act.
Telix Pharmaceuticals Limited (ASX: TLX)
==> picture [271 x 234] intentionally omitted <==
==> picture [176 x 97] intentionally omitted <==
Precision Oncology See it. Treat it.
www.telixpharma.com IR contact: Kyahn Williamson Email: [email protected]