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Telix Pharmaceuticals Ltd AGM Information 2019

May 21, 2019

31324_rns_2019-05-21_39ada56d-62c2-499b-a973-b0e10cd6359c.pdf

AGM Information

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CEO’s Address

Annual General Meeting

Melbourne (Australia) – 22 May 2019 . Telix Pharmaceuticals Limited (ASX.TLX, “Telix”), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on “molecularly-targeted radiation” (MTR), is pleased to provide a transcript of the CEO’s address to the Annual General Meeting of Shareholders being held today at 10.30am, at The Larwill Studio, 48 Flemington Road, North Melbourne.

CEO’S ADDRESS

The past 12 months has been a period of extraordinary growth for Telix.

Since the last AGM we have become a clinically active company with multiple clinical trials launched around the globe, including the ZIRCON Phase III trial for renal cancer imaging and the IPAX-1 glioblastoma therapy study. Today the company has 8 clinical trials in progress either as company-sponsored trials or as a collaborator to an investigator-led study. Telix is clinically active in 17 countries and it is remarkable to note that in the last 12 months our activity has developed to the point where every single day, patients all over the world are benefitting from our technology.

The effort and execution to achieve this in a such a short period of time has been significant and I’d like to acknowledge the tireless efforts of the entire Telix team around the globe. As these trials ramp up over the next few months and get to the point where we can better forecast patient enrolment rates, we’ll be providing regular updates on recruitment progress.

Underpinning these clinical studies is a manufacturing and supply chain network that is world class, with international reach. Our manufacturing network is capable of delivering product for multi-centre clinical trials as well as having sufficient scale to support early commercialisation of our products in key territories. Due to the relatively short shelf-life of radiopharmaceutical products, a sophisticated and reliable supply chain is vital due to the “just-in-time” manufacturing nature of our products. Several important corporate partnerships with firms such as Cardinal Health (USA), Isologic (Canada), ITM (Germany), Cyclotek (Australia) and JFE (Japan) enable us to achieve this reach.

In general, Telix had a very commercially active 12 months, both in terms of partnering discussions and collaboration activity in relation to our pipeline, but we were also active on the M&A front. We completed two acquisitions last year, both of which bring significant future value to the company and further expand Telix’s international footprint.

The first acquisition was Atlab Pharma SAS, a French firm with an intellectual property portfolio and extensive clinical data that is highly beneficial to the development of Telix’s prostate cancer therapy program. The Atlab transaction effectively acts as an accelerant to Telix’s program and enables Telix to defend certain clinical applications around combination therapies with anti-androgen drugs that we believe will be commercially important to the field in the near future.

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Advanced Nuclear Medicine Ingredients (ANMI) SA, was the second acquisition. In a relatively short period of time the ANMI team has built a stellar reputation for radiochemistry excellence and developed some very innovative products that we are excited to add to the Telix portfolio. ANMI platforms and people will contribute to almost every aspect of Telix’s product development activity in the coming months and years, and the combining of the two companies means that we are now one of the leading urologic oncology imaging firms.

One of the success stories for Telix over the past 12 months has been the prostate imaging product, which is branded in the US as illumet[TM] . The rate at which we have been able to commercialize this product was not envisaged at the time of the IPO and is reflective of the considerable impact on patient care and demand for better imaging technologies to manage metastatic prostate cancer. We are making good progress toward submitting a new drug application (NDA) in the United States and making similar inroads toward product approval in Europe. I also note that as of a few weeks ago, PSMA imaging with Positron Emission Tomography (PET) has become formally adopted as standard care in the European Urology Association (EAU) guidelines. This certainly helps pave the way for the Telix/ANMI prostate cancer imaging product in Europe.

I would like to note Telix’s transition to becoming a revenue-generating company. Although it is early days and modest sales are from the use of our products on an investigational or compassionate use basis, the discipline of selling, managing customer relationships, implementing processes to manage risk and the discipline of forecasting, marks a major cultural change in the Company. Over a hundred tertiary-referral cancer centres in a dozen countries use a Telix product on a routine basis or as part of clinical trials, paving the way for far more significant revenues when we achieve marketing authorisations in the various jurisdictions.

Over the next 6 months, we will achieve multiple inflection points for the company that will have a significant impact on the valuation and prospects of the business. In the near-term, there are key milestones related to our NDA submission for the prostate cancer program in the US, as well as feedback from the FDA in relation to both the ZIRCON trial and a prospective Phase III trial for our prostate cancer therapy program in the US. Before the end of the year we will also significantly advance our renal cancer therapy programs and our glioblastoma therapy program. In short, 2019 is a pivotal year for Telix.

Finally, the progress of the company must also be considered against the backdrop of the industry overall. Nuclear medicine has finally started to hit its stride and the focus and attention from mainstream oncology for both imaging and therapeutic applications has increased significantly. There have been several notable transactions in our space over the past 12-18 months that reflect the renewed attention our field is getting, and reinforce the relevancy of what Telix is seeking to accomplish.

We are immensely appreciative of the support and engagement of our shareholders, and we are grateful to our clinical partners and patients for the commitment they have demonstrated to our product development activity. We look forward to keeping you informed of our progress is the coming months.

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About Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited (Telix) is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR). The company is headquartered in Melbourne with international operations in Brussels (EU), Kyoto (JP) and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX:TLX). For more information visit www.telixpharma.com.

Telix Corporate Contact

Telix Investor Relations

Dr. Christian Behrenbruch Lisa Wilson Telix Pharmaceuticals Limited In-Site Communications CEO Tel: +1 212 452 2793 Email: [email protected] Email: [email protected]

Important Information

This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “US Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the US Securities Act or an exemption from the registration requirements of the US Securities Act is available. None of the products referred to in this release have obtained a marketing authorization in any jurisdiction.

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CEO AGM Address ASX:TLX

22[nd] May, 2019

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Notices

The information contained in the presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (“Telix”) in any jurisdiction, including the United States. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained in this document or opinions expressed in the course of this presentation. The information contained in this presentation is subject to change without notification.

This presentation contains forward-looking statements which can be identified by the use of words such as “may”, “should”, “will”, “expect”, “anticipate”, “believe”, “estimate”, “intend”, “scheduled” or “continue” or similar expressions. Any forward-looking statements contained in this presentation are subject to significant risks, uncertainties, assumptions, contingencies and other factors (many of which are outside the control of, and unknown to Telix, and its officers, employees, agents or associates), which may cause the actual results or performance to be materially different from any future result so performed, expressed or implied by such forward-looking statements.

There can be no assurance or guarantee that actual outcomes will not differ materially from these statements. The data and results pertaining to clinical subjects used in this presentation are illustrative of medical conditions and outcomes associated with potential applications of Telix’s product pipeline. Actual results from clinical trials may vary from those shown. None of the products or potential products described in this presentation have received a marketing authorization in any jurisdiction.

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Melbourne
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The Last 12 Months

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  • Headcount growth to ~50 FTEs globally

  • 4 international locations – Melbourne HQ

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Kyoto
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  • Two acquisitions : Atlab Pharma SAS (France) and ANMI SA (Belgium)

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  • Clinically active in 17 countries

  • 8 clinical trials including company-sponsored and investigator-led

  • Every day patients receive a Telix product … somewhere

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Liege
Indianapolis
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Multiple commercial partnerships with leading global healthcare companies

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Extensive Supply Chain and Production Network Established

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ü Key partners in place
ü For clinical trials and
early commercial
product roll-out
ü Discussion ongoing
with partners for
MENA, Asia
and LATAM Backup
4
Backup
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M&A Activity

M&A is an important facet of Telix’s corporate activity as we continue to build a leading pipeline of radiopharmaceutical products and technologies

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  • Origin: Spin-out from Centre Hospitalier Universitaire (CHU) de Nantes (France), a leading European nuclear medicine cluster

  • Consideration: $USD 10m in scrip

  • Purpose: access to clinical data and patent portfolio in relation to huJ591 anti-PSMA mAb, particularly for combination therapy with anti-androgens and image-based patient selection

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  • Origin: Liège (Belgium)-based nuclear medicine start-up

  • Consideration: €5.1m in cash / scrip + earn-out

  • Purpose: EU/RoW rights to PSMA imaging technology and access to an early-stage pipeline of “kit” technologies for other oncology application areas, talent acquisition

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Early TLX591-CDx Adoption is Growing Fast

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1
49 5
3
8 5
5
2 8
1
1
3
7
1
Australia: 1
1
UAE: 1
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ü >100 sites around the world use the product routinely or in clinical trials

  • ü Mostly large cancer centres that are capable of doing 10-15 pts a week (upon product approval)

ü Sales on track to deliver between 10,000 and 15,000 doses in 2019 (globally)

  • ü Average reimbursed pricepoint (post-approval) of USD ~$3,500 / €2,200

  • *68Ga-PSMA-11 is an investigational product and has not received marketing authorization in any jurisdiction

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Multiple Milestones and Readouts in 2019

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Q1 Q2 Q3 Q4
US/JP [2] IND Filed Enrolment Complete
Imaging
(Phase III)
Therapy
(Phase I/II)
Mfg completed US IND Filed FPI Update Interim Results
Info Package to FDA Pre-NDA meeting NDA Go/No Go
Imaging NDA [1] (US) TLX591
Therapy
(Phase III)
Info Packa e to FDA Pre-IND meetin Phase III Go/No Go First Patient In
g g
Therapy
(Phase I/II)
Interim Results
Recruitment update
Regulatory milestone
Clinical trial milestone
1 New Drug Application, subject to regulatory approval
2 Japanese CTN is Phase I/III “bridging study” 7
Renal Cancer
Cancer
Prostate
GBM
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Valuation Benchmarks : Plenty of Sector Activity

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  • § Competing PhIII prostate program

  • § Sold to Novartis in Dec 2018 for USD $2.1Bn (AUD $2.9Bn)

  • § Limited pipeline, most of the valuation based on a single orphan program (Lutathera®)

  • § Sold to Novartis in Jan 2018 for USD $3.9Bn (AUD $5.5Bn)

  • § NASDAQ: PGNX

  • § Market cap USD $390m (AUD $550m)

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  • § Privately held UK company, majority held by Syncona LIC.

  • § Est market cap of ~£200m (AUD $370m)

  • § Telix is successfully displacing BE’s products

  • § Sold to CDH in June 2018 for AUD $1.9Bn

  • § CDH bid usurped Varian Medical Systems

  • § NO: NANO, limited midstage pipeline

  • § Market cap NOK 2.53Bn (AUD $415m)

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www.telixpharma.com

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