On October 18, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported its Appendix 4C quarterly cash flow report and accompanying Activities Report for the quarter ended 30 September 2023 (Q3 2023) (Press release, Telix Pharmaceuticals, OCT 18, 2023, View Source [SID1234636126]). All figures are in AUD$ unless otherwise stated[1] and provided on an unaudited basis.
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Summary
Total revenue of $133.6M, up from $120.7M (Q2 2023)
Fourth consecutive quarter of positive operating cash flow ($21.4M, up $10.6M on the prior quarter)
Cash receipts from customers up 16% to $130.7M ($112.2M in the prior quarter)
Closing cash balance of $137.4M (compared to $131.7M at prior quarter end)
Managing Director and Group CEO, Dr Christian Behrenbruch commented, "The achievement of a fourth consecutive quarter of positive operating cash flow is a major milestone that reflects the Company’s maturation as it delivers on its commercial goals and progresses the development of its industry-leading pipeline.
"We have posted another quarter of double-digit revenue growth for Illuccix in the U.S. with average daily demand for doses continuing to grow month-on-month. Just as importantly we have a number of near-term value drivers on the horizon, being the commencement of the ProstACT GLOBAL study and advancing the U.S. regulatory filing and commercial launch preparations for our renal (kidney) and brain cancer imaging agents. This is reflected in our investment during the quarter in research and development and commercial launch preparation, in line with our stated plans."
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) improved 13% to $130.6M (US$85.2M), up from $116.0M in Q2 2023.
Worldwide revenue
Total revenue of $133.6M was generated during the quarter (including commercial sales of Illuccix in the U.S.). Ex-U.S. revenue (including compassionate use availability of Illuccix / TLX591-CDx)[2] was $3.0M.[3]
Net cash from operating activities
Telix delivered its fourth consecutive quarter of positive net operating cash inflow. The net operating cash inflow for the quarter was $21.4M, a $10.6M improvement on the prior quarter (Q2 2023, net operating cash inflow $10.8M). In line with increased revenue and improved collections, cash receipts from customers improved 16% to $130.7M, up from $112.2M in the prior quarter.
The closing cash balance at 30 September 2023 was $137.4M ($131.7M 30 June 2023). The net operating cash inflow was partially offset by cash outflows from investing activities which included an annual payment of $17.8M for the first instalment of the contingent consideration payable to former Telix Innovations (ANMI) shareholders, based on Illuccix sales.
Increased product manufacturing and related costs reflect higher volume of sales activity and preparation for future product launches. Gross margin is broadly in line with the previous quarter at 63% and reflects stable selling prices and manufacturing costs.
R&D expenditure[4] is in line with plan and reflects the momentum in the key near-term value drivers for the Company being the commencement of the ProstACT GLOBAL study and advancing the U.S. regulatory filings for the TLX250-CDx Biologics License Application (BLA) and TLX101-CDx New Drug Application (NDA).
Illuccix global regulatory update
Telix is progressing new marketing authorisations for Illuccix in a number of jurisdictions, including the United Kingdom (U.K.), European Union (E.U.)[5] and Brazil. As previously reported, these respective applications are currently undergoing assessment and the Company will provide an update on any material changes to status. A Phase III study intended to bridge to the marketing authorisation granted to Illuccix by the United States Food and Drug Administration (FDA) is in progress and recruiting well in China.[6]
During the quarter the Company participated in a formal pre-NDA meeting with the Japanese regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) as part of its preparation towards a regulatory filing for Illuccix in Japan. The outcome was clear and helpful feedback to support a regulatory submission of Illuccix in Japan in 2024.
Clinical Programs Update
Telix has an industry leading pipeline of late-stage radiopharmaceutical therapeutics and associated diagnostic imaging agents, underpinning its commitment to targeted, precision oncology. The core pipeline is focused on prostate cancer, renal cancer, brain cancer (glioma) and rare diseases (hematologic cancers and bone marrow conditioning). The Company has over 20 clinical studies underway worldwide, including Telix-sponsored and collaborative investigator- initiated trials.
During the quarter, notable updates were published in the news section of the Company’s website (www.telixpharma.com/news-views) and are summarised in this section of the Activities Report.
Priority focus areas for the clinical pipeline:
Progression of the prostate cancer therapy program (TLX591, Lutetium (177Lu) rosopatamab tetraxetan):
The Phase III ProstACT GLOBAL study (ClinicalTrials.gov ID: NCT04876651) is now open for enrolment in Australia, with additional sites in the Asia Pacific region currently being onboarded. The study is expected to open for enrolment in the U.S. following acceptance of an investigational new drug (IND) application, scheduled for filing in Q4 2023.
Preparation of a BLA submission and commercialisation of TLX250-CDx (89Zr-DFO-girentuximab), 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 has received a formal acceptance letter from the FDA in response to a request for a rolling review of the BLA. This is an important positive development, which allows the applicant to submit portions of a BLA or NDA separately, when corresponding data becomes available. This enables the FDA to consider reviewing key modules in advance of receiving the entire application, making the review process more efficient and potentially shortening the overall review period. The Company continues to progress its BLA submission in 2023 as planned.
Telix has obtained clearance to commence its Expanded Access Program (EAP) in the U.S. with multiple sites now actively screening patients. Compassionate use access programs are active in Europe and Australia, to provide TLX250-CDx to patients and physicians in areas of unmet need, prior to obtaining marketing authorisation in accordance with the applicable permitted regulatory pathways. 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.
Preparation of a NDA submission for TLX101-CDx (18F-FET), Telix’s investigational brain cancer imaging agent: Telix has significantly progressed the NDA filing for TLX101-CDx, including formal consultation with the FDA around the final proposed clinical package. Based on this feedback, the NDA submission will occur in Q1 2024 in order to enable Telix to include additional clinical data (already in possession). In addition to this, the Company has filed an application to commence an EAP in the U.S. that is expected to open for patient access in November 2023, subject to regulatory clearance.
CAIX program (TLX250-CDx / TLX250): Multiple studies underway to support theranostic indication expansion
Telix has multiple clinical studies in its CAIX program, exploring the potential of this target in combination with immunotherapy for the treatment of ccRCC and also its potential 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.
The first patients have now been dosed in 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).[7] The open label, single-arm, multi-centre 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.
The Phase II OPALESCENCE investigator-initiated trial (IIT) of TLX250-CDx in triple-negative breast cancer (ClinicalTrials.gov ID: NCT04758780) has completed enrolment with top-line data anticipated shortly.
TLX101 brain cancer (glioblastoma) therapy program update
Dosing of the first cohort of patients has been completed in the Phase I IPAX-2 study of TLX101 (4-L-[131I] iodo- phenylalanine, or 131I-IPA), running at sites across Australia, New Zealand and Europe. IPAX-2 (ClinicalTrials.gov ID: NCT05450744) seeks to confirm the safety profile of TLX101 as a front-line therapy in combination with standard of care (SoC) 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),[8] TLX101 is being further investigated in the recurrent setting in the Phase II IPAX-Linz IIT, which is progressing well and has now exceeded 70% of the patient enrolment target.
Grand Pharma partnership: First patients dosed in Chinese imaging studies
Two studies are being conducted in collaboration with the Company’s strategic partner for the Greater China region, Grand Pharmaceutical Group Limited 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.
During the quarter, patient dosing commenced in the Phase III registration study of TLX591-CDx (Illuccix) (ClinicalTrials.gov ID: NCT05847348)[9] and additional sites were opened.
Related Party Transactions
Telix confirms that payments noted under section 6.1 of the accompanying Appendix 4C include payments of $0.3M to ABX-CRO advanced pharmaceutical services (of which Non-Executive Director Dr Andreas Kluge is Managing Director) for the provision of clinical and analytical services for the Company’s development programs. Payments of $0.3M were made to Directors for Director fees and Managing Director salary.
Investor Call
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