MELBOURNE, Australia, April 17, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today issues its Appendix 4C quarterly cash flow statement and accompanying Activities Report for the quarter ended 31 March 2023 (Q1 2023). All figures are in AUD$ unless otherwise stated^[1] and provided on an unaudited basis.

Summary

• Total revenue for the quarter reaches $100.1M, driven by global sales of Illuccix, Telix's prostate cancer imaging agent
• Demand for Illuccix in the United States continues to increase with sales of $97.5M (up from $76.8M in the prior quarter)
• Second consecutive quarter of positive operating cash flow ($2.4M, an improvement of $0.8M on the prior quarter)
• Cash receipts from customers were $83.2M, up 15% from $72.2M in the prior quarter
• Closing cash balance of $121.4M at 31 March 2023 (compared to $116.3M at 31 December 2022)

Group CEO and Managing Director Dr Christian Behrenbruch commented, "In just under a year since the commercial launch of Illuccix and five years since listing on the ASX, Telix has delivered a significant milestone with its first $100M revenue quarter. We are making a meaningful difference in the lives of thousands of prostate cancer patients and delivering on our mission of global leadership in radiopharmaceuticals. Telix is able to fund the development of new imaging agents and novel therapeutics, evident in recent achievements and delivery of our second consecutive quarter of positive operating cash flow."

Commercial Activities Report

Americas region: U.S. sales growth trend continues, commercial launch underway in Canada

Revenue from U.S. sales of Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) increased to $97.5M (US$66.2M). Demand for Illuccix continues to grow in line with the increasing market adoption of PSMA-PET imaging from both existing accounts and new customer acquisition.

During the quarter the U.S. Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) for Illuccix, resulting in an expanded label indication to identify and select patients who are candidates for the only FDA-approved prostate specific membrane antigen (PSMA)- directed radioligand therapy.^[2]

"The demand for Illuccix continues to grow across all of our customer segments. Our focus on service and reliable delivery of doses is helping us to win and retain customers. Our recent focus on Illuccix's clinical differentiation and the expanded label to include patient selection for radioligand therapy is resonating with clinicians and helping to drive deeper engagement with our customers," stated Kevin Richardson, CEO of Telix Americas.

During the quarter, the Company also launched Illuccix in Canada, where it is the first and only PSMA-PET imaging agent to have received regulatory approval. Illuccix is now available nationwide through Telix's partner, Isologic Innovative Radiopharmaceuticals.^[3]

Worldwide revenue

Total revenue of $100.1M was generated during the quarter (including commercial sales of Illuccix in the U.S.). Ex-U.S. revenue (including sales of Illuccix / TLX591-CDx)^[4] was $2.6M.

Net cash from operating activities

Telix delivered its second consecutive quarter of positive net operating cash inflow. The net operating cash inflow for the quarter was $2.4M, a $0.8M improvement on the prior quarter (Q4 2022, net operating cash inflow $1.6M). In line with increased revenue, cash receipts from customers improved 15% to $83.2M, up from $72.2M in the prior quarter. The closing cash balance at 31 March 2023 was $121.4M ($116.3M 31 December 2022).

Payments for product manufacturing and related costs reflect higher volume of sales and timing of supplier payments, with gross margin remaining in line with the previous quarter at 63%.

Illuccix global regulatory update

Telix is progressing marketing authorisations for Illuccix in a number of jurisdictions, with priority focus this past quarter on the United Kingdom (UK) and European Union (EU). On 3 April 2023, the Company provided a progress update on its European regulatory filings for Illuccix where a Marketing Authorisation Application (MAA) was submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA). The review period for the UK MAA follows a 150-day national application procedure.^[5]

The process of submitting an EU MAA is underway. The German regulatory authority, BfArM Federal Institute for Drugs and Medical Devices has been selected to serve as Reference Competent Authority (CA). The Company will advise on the review timetable upon final acceptance of the dossier by the Reference CA and the corresponding member states.

Clinical Programs Update

Telix continues to progress its core therapeutic and diagnostic pipeline, with a focus on prostate cancer, renal (kidney) cancer, brain cancer (glioma) and rare diseases (bone marrow conditioning). The Company has over 20 clinical trials underway, including Telix-sponsored studies and collaborative investigator-initiated studies.

During the quarter, notable updates were published on the news section of the Company's website (www.telixpharma.com/news-views) and are summarised below.

Priority focus for the clinical pipeline is in three key areas:

• Preparation of a Biologics License Application (BLA) and commercialisation of TLX250-CDx, Telix's investigational kidney cancer imaging agent: As supported under the Breakthrough Therapy Designation, the Company is actively engaging with the FDA as it prepares its regulatory filing. The Company expects to participate in a Type B meeting in the coming quarter to gain formal feedback on its submission. Further information on pre-commercialisation activity is detailed below.
• Preparation of a New Drug Application (NDA) for TLX101-CDx, investigational brain cancer imaging agent: During the quarter the Company participated in a successful consultation meeting with the FDA with the purpose of obtaining guidance and feedback on its proposed approach to the regulatory submission. Based on this positive discussion, the Company reconfirms its expectation to file an NDA during 2023.
• Progression of the prostate cancer therapy program (TLX591): Australian and New Zealand site engagement for recruitment into the ProstACT GLOBAL Phase III study has been a focus for the Company. Regulatory applications are in preparation to expand the study to the U.S. in H2 2023. Enrolment of the ProstACT SELECT study is complete (25 patients) with data to be reported in H2 2023.

Pre-commercialisation activities and regulatory submission for TLX250-CDx

Detailed positive results from the completed pivotal Phase III ZIRCON trial (ClinicalTrials.gov Identifier: NCT03849118)^[6] were presented to the medical community for the first time at the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (ASCO GU)^[7] in an oral presentation from Associate Professor Brian Shuch, MD, Director, Kidney Cancer Program, UCLA Institute of Urologic Oncology (Los Angeles, California) and a Principal Investigator in the study.

The results were also featured in a 'game-changing' oral presentation at the 38th Annual European Association of Urology (EAU) Congress, delivered by Professor Peter Mulders, Head of Urology at Radboud University Nijmegen Medical Centre and a Principal Investigator in the ZIRCON study. 'Game changing' sessions are reserved for Phase III trials or other developments that the EAU's Scientific Congress Office believes will have a large impact on daily practice.

The detailed analyses showed highly consistent results across three readers of an average 86% sensitivity and 87% specificity. This exceeded the pre-determined threshold required to demonstrate the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate and non-invasive method for identifying the presence and spread of clear cell renal cell carcinoma (ccRCC). Confidence intervals (CIs) exceeded expectations in all three readers showing high accuracy and consistency of image interpretation.^[7]

The release of detailed results builds on the top-line data reported in November 2022, confirming the study has met its co-primary endpoint with sensitivity of 84% and specificity of 84% in all three readers.

The full data set also supported the accuracy of the imaging agent with 93% positive predictive value / 75% negative predictive value (secondary endpoints).

"The excellent results of the ZIRCON study are generating widespread interest in the urology field. Physicians can foresee the clinical utility in this non-invasive tool that exceeds conventional imaging in its ability to detect and characterise ccRCC and enables physicians to make an informed decision on optimal treatment pathways", stated Dr Colin Hayward, Chief Medical Officer at Telix.

Telix is currently rolling out an early access program to provide this important diagnostic to patients and physicians as well as planning new research into other areas of high unmet need in cancers expressing carbonic anhydrase IX (CAIX).

TLX101 brain cancer (glioblastoma) therapy program sites initiated

The Company has initiated the IPAX-2 study (ClinicalTrials.gov Identifier: NCT05450744) to confirm the safety profile of TLX101 as a front-line therapy in combination with standard of care treatment, ahead of progressing to a label-indicating Phase II/III study in a larger patient population, IPAX-3.^[8] The IPAX-2 study, which will enrol 12 patients, is expected to imminently commence dosing patients at Australian sites.

Partnership with Grand Pharma advances multiple programs into the clinic

The Company's partnership with Grand Pharmaceutical Group Limited (Grand Pharma), Telix's development partner in Greater China is making progress across multiple programs. In China, sites are being prepared for studies of TLX591-CDx and TLX250-CDx - which will bridge to FDA approval of Illuccix and the ZIRCON study for kidney cancer imaging, respectively - to establish equivalent efficacy in Chinese and Western populations. It is anticipated that first patients will be dosed in both studies during Q2 2023.

Subsequent to quarter end, the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) approved a Phase I study of TLX101 investigational therapy (4-L-[¹³¹I] iodo-phenylalanine, or ¹³¹I-IPA) in Chinese patients with newly diagnosed glioblastoma (GBM) that will bridge to Telix's planned global Phase II/III IPAX-3 study.^[9] This is the first of Telix's investigational therapies to move into a clinical trial with Grand Pharma.

Research and Innovation (R&I) Highlights

Telix remains at the forefront of innovation in radiopharmaceuticals by investing a small proportion of its R&D budget into the development of new targets and technologies. The goals of Telix's R&I programs are to enhance existing product candidates through innovation and life-cycle management and identify promising new clinical targets and assets for introduction into the product candidate pipeline. Key highlights include:

Antibody in-licensed from Lilly progresses to clinical studies

Subsequent to quarter-end, on 17 April 2023, Telix announced the successful preclinical development of radiolabelled olaratumab, an antibody licensed from Eli Lilly and Company (Lilly) in April 2022.^[10] Olaratumab was originally developed as a naked (non-radiolabelled) monoclonal antibody targeting Platelet Derived Growth Factor Receptor Alpha (PDGFR), a target expressed in multiple tumour types. Telix has demonstrated preclinical proof-of-concept by using olaratumab to selectively deliver both diagnostic and therapeutic radiation to tumours as a radiopharmaceutical moiety and has produced a candidate for clinical translation.

The program will now progress to first-in-human clinical studies based on these highly encouraging results with the agent assigned formal candidate status in Telix's development pipeline (to be denoted as TLX300-CDx/TLX300 for the diagnostic/patient selection tool and therapeutic, respectively).

Investor Call

An investor conference call and webcast will be held at 9.00am AEST on Tuesday 18 April (7.00pm EDT, Monday 17 April). Participants can register for the conference call at this link: https://s1.c-conf.com/diamondpass/10030024-t5emod.html

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About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland) and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on Twitter (@TelixPharma) and LinkedIn.

TLX250-CDx (⁸⁹Zr-DFO-girentuximab) has not received a marketing authorisation in any jurisdiction. Telix's lead product, Illuccix or kit for preparation of gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),^[11] by the Australian Therapeutic Goods Administration (TGA),^[12] and by Health Canada.^[13] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom.^[14]

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: [email protected]

Legal Notices

This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward- looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website.

2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).