20 July 2023 | Thursday | News
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Managing Director and Group CEO, Dr Christian Behrenbruch commented, "Q2 2023 was another strong quarter for Telix, characterised by the ongoing trend of double-digit revenue growth from sales of Illuccix® and continued positive operating cash flow. This is reflective of our excellent commercial performance and strength in PSMA-PET imaging in all of Telix's operating markets.
"Simultaneously we are focused on the marketing authorisation of two further products for kidney and brain cancer imaging. Following successful planning meetings with the United States Food and Drug Administration (FDA), we are focused on preparing regulatory marketing applications, scaling up manufacturing and preparing for future product approvals and launch. Momentum also continues to build with our therapeutic pipeline, with clear clinical progress delivered across our prostate, kidney and glioblastoma programs. This activity is reflected in our investment in research and development (R&D), which remains in line with our stated plan."
During the quarter Telix opened its manufacturing site in Brussels South, and announced two modest acquisitions. These strategic initiatives broaden the late-stage pipeline and further enhance Telix's position as a vertically-integrated radiopharmaceutical company to support a breadth of future product offerings across the continuum of patient care.
"Our depth and commitment to urologic oncology starts with Illuccix and, with the agreement to acquire Lightpoint Medical, now continues into surgical intervention. We have also added to our artificial intelligence (AI) capability through the acquisition of Dedicaid GmbH, which brings with it a dedicated team of scientists to bridge reader and clinical decision support, and eventually disease prediction.
"Finally, the inauguration of our European radiopharmaceutical production facility – Telix Manufacturing Solutions – represents a significant milestone for the Company and a vital step towards building the foundation for long-term, commercial success and delivering to the needs of patients," added Dr Behrenbruch.
Commercial Activities Report
Americas region: United States (U.S.) and Canada
Revenue from U.S. sales of Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) increased by 19% to $116.0M (US$77.6M), up from $97.5M in Q1 2023.
Total revenue of $120.7M was generated during the quarter (including commercial sales of Illuccix in the U.S.). Ex-U.S. revenue (including sales of Illuccix / TLX591-CDx) was $4.7M.
Net cash from operating activities
Telix delivered its third consecutive quarter of positive net operating cash inflow. The net operating cash inflow for the quarter was $10.8M, an $8.4M improvement on the prior quarter (Q1 2023, net operating cash inflow $2.4M). In line with increased revenue and improved collections, cash receipts from customers improved 35% to $112.2M, up from $83.2M in the prior quarter.
The closing cash balance at 30 June 2023 was $131.7M ($121.4M 31 March 2023).
Increased product manufacturing and related costs reflect higher volume of sales and preparation for future launches. Gross margin broadly in line with the previous quarter at 64% reflects stable selling prices and manufacturing costs.
Illuccix global regulatory update
Telix is progressing new marketing authorisations for Illuccix in a number of jurisdictions, including the United Kingdom (U.K.) and European Union (E.U.). The Company's Marketing Authorisation Application (MAA) for the E.U. has now been validated by Germany's regulatory health authority, Federal Institute for Drugs and Medical Devices (BfArM), serving as Reference Competent Authority. The formal review procedure commences in July 2023. Based on the standard review timetable of 210 days, plus allowances for clock stop periods, a regulatory decision is expected in H1 2024.
Clinical Programs Update
Telix continues to progress its core oncology pipeline of therapeutic and diagnostic agents, with a focus on prostate cancer, renal (kidney) cancer, brain cancer (glioma) and rare diseases (hematologic cancers and bone marrow conditioning). The Company has over 20 clinical studies underway, including Telix-sponsored and collaborative investigator-initiated trials.
Priority focus areas for the clinical pipeline:
Telix is in the process of implementing an Expanded Access Program (EAP) in the U.S. and providing compassionate use access in the rest of world, to provide TLX250-CDx to patients and physicians in areas of unmet need, prior to obtaining marketing authorisation. During the quarter the first sites and requests were on-boarded and fulfilled. The Company is also conducting new research and clinical studies to explore the theranostic utility of this investigational asset in other cancers expressing carbonic anhydrase IX (CAIX), where there are currently high unmet medical needs.
New ZIRCON data presented at SNMMI: Supports potential for expanded clinical utility of TLX250-CDx in staging and monitoring ccRCC
Additional data from the completed pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) was presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting in Chicago. New data demonstrated the ability of TLX250-CDx to detect extrarenal clear cell renal cell carcinoma (ccRCC), with more lesions detected in liver and bone than with diagnostic computed tomography (CT) imaging alone. These findings support the potential clinical utility of TLX250-CDx in the metastatic or recurrent setting, enabling the staging and monitoring of high-risk patients.
This data reinforces the performance of this investigational diagnostic imaging agent across all analyses, with previously presented data showing an excellent overall sensitivity and specificity of 86% and 87%, respectively, together with excellent intra-reader agreement.,
CAIX program (TLX250-CDx / TLX250): Two additional studies underway support theranostic indication expansion
Telix has launched two additional clinical studies in its CAIX program, exploring the potential of this target across a broad range of cancer indications. CAIX is a protein overexpressed on the surface of ccRCC, the cancer target in Telix's successful Phase III ZIRCON study. It is also expressed to varying degrees in many other advanced-stage solid tumours with poor prognoses.
A first patient was dosed in the STARBURST study of TLX250-CDx during the quarter (ClinicalTrials.gov ID: NCT05563272). This prospective, open label, Phase II "basket" trial is investigating CAIX expression in patients with a diverse range of solid tumours – including breast, cervix, colorectal, gastric, esophageal, head and neck, lung, ovarian, pancreatic and vulval cancers – for potential diagnostic and therapeutic applications.
The imaging study builds on encouraging preliminary data from two investigator-initiated trials in triple-negative breast cancer and non-muscle-invasive bladder cancer with the purpose of theranostic "scouting" for future studies harnessing therapeutic radionuclides.
The Company has now commenced the STARSTRUCK therapeutic study (ClinicalTrials.gov ID: NCT05868174) of TLX250 (177Lu-DOTA-girentuximab) in combination with a Merck KGaA, Darmstadt, Germany DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib (M3814). The Phase Ib, open label, single-arm, multicentre dose escalation and dose expansion study is evaluating safety profile, dosing and activity and will enrol up to 80 patients with CAIX- expressing solid tumours at Australian sites.
TLX101 brain cancer (glioblastoma) therapy program update
All Australian and New Zealand sites in the Phase I IPAX-2 study of TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) have been activated and are screening patients. IPAX- 2 (ClinicalTrials.gov Identifier: NCT05450744) seeks 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.
In parallel, building on the success of Telix's Phase I/II IPAX-1 study (ClinicalTrials.gov ID: NCT03849105), TLX101 is being further investigated in the recurrent setting in the investigator-initiated Phase II IPAX-Linz trial, which is progressing well and has now exceeded 50% of the patient enrolment target.
Grand Pharma partnership: First patients dosed in Chinese imaging studies
Sites are in the process of opening and patients are currently being screened for inclusion into the pivotal Phase III registration study of TLX591-CDx (Illuccix) (ClinicalTrials.gov ID: NCT05847348).
The first patient has been dosed in a Phase I study of TLX250-CDx PET imaging of ccRCC. ZIRDOSE-CP (ClinicalTrials.gov ID: NCT05861778) precedes the multi-centre Phase III ZIRCON-CN registration study in China.
Both studies are being conducted in collaboration with the Company's strategic partner for the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma) to demonstrate that the diagnostic utility of TLX591-CDx and TLX250-CDx is equivalent in Chinese and Western populations. The data generated will support future marketing authorisation applications for the Company's prostate and renal cancer imaging agents, in China.
Pipeline Expansion and Advanced Manufacturing Highlights
Urologic product offering enhanced with two acquisitions
Telix is building on its differentiated offering for the field of urologic oncology with the announcement of two acquisitions during the quarter – Lightpoint Medical (Lightpoint) and Dedicaid GmbH (Dedicaid) – which accelerate the Company's late-stage development programs in surgical technology and AI, respectively. Both of these technologies are complementary to the Company's existing product and research pipeline, further enhancing Telix's innovation position and product depth for the urology customer and patient. The Lightpoint acquisition agreement is subject to completion of agreed closing conditions.
Lightpoint's SENSEI® device is an ultra-miniature robotic gamma probe for intra-cavital use that is able to provide radiopharmaceutical-based surgical guidance (radio-guided surgery) by enabling the intra-operative detection of cancer in real-time. Telix's initial commercial objective is to align SENSEI with Telix's Illuccix and TLX599-CDx (99ᵐTc-HYNIC- iPSMA) programs for prostate cancer. Additionally, there is considerable scope to expand into other urologic and non- urologic malignancies. Lightpoint also has innovative capabilities in AI for surgical guidance that will complement Telix's AI program. SENSEI has been approved by the FDA and has attained a Conformité Européenne (CE) Mark in Europe for intra-operative detection of sentinel lymph nodes and cancer metastasis via the lymphatic system, and is currently the only gamma probe validated for use with the Intuitive Surgical DaVinci® robotics system.
The acquisition of Dedicaid expands Telix's AI offering, with the addition of a clinical decision support software platform designed to predict outcomes such as the severity of disease, risk to the patient and/or inform treatment decisions.
The Dedicaid AI platform is also favourably differentiated from commercially-available AI solutions currently used in PSMA-PET imaging, which are limited to supporting clinicians in the interpretation and reading of images – without a prediction capability.
Telix Manufacturing Solutions opens in Brussels South
Buildout of Stage 1 of Telix's European manufacturing site is now complete. Located in the heart of Belgium's "Radiopharma Valley", the 2,800 square metre facility is one of Europe's largest radiopharmaceutical production facilities. It will serve as the Company's primary manufacturing site for radioisotopes and commercial and clinical products for patients in the Europe, Middle East and Africa region and beyond.
The first stage of the buildout included installation of nine Good Manufacturing Practice (GMP) manufacturing lines, two R&D laboratories (including one dedicated to alpha-therapy), quality control laboratories and warehousing space with capacity to support Telix's existing and planned future operations. The Company is also preparing to install the first of two planned cyclotrons for the site. The site is now operational for R&D activity and is undergoing final preparations to obtain GMP certification, anticipated in 2024.