On February 22, 2024 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported its results for the financial year ended 31 December 2023. All figures are in AUD$ unless otherwise stated (Press release, Telix Pharmaceuticals, FEB 22, 2024, View Source [SID1234640404]).

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2023 highlights

Total Group revenue of $502.5M, an increase of 214% from $160.1M in 2022 primarily driven by continued strong growth in sales of Illuccix in the second year since commercial launch (April 2022)
Delivered positive adjusted earnings before interest, tax, depreciation, and amortisation (adjusted EBITDA) of $58.4M an increase of $126.2M, compared to a loss of $67.8M in 2022
Inaugural full year profit of $5.2M after tax. A substantial improvement on the net loss after tax of $104.1M in 2022
Investment in research and development (R&D) and selling, general and administration (SG&A) reflects progress across the late-stage pipeline and scale-up of the commercial organisation
Overall operating costs as a percentage of revenue have reduced to 52% from 105% in 2022
Gross margin has improved to 63% (vs. 59% in 2022) reflecting distribution and manufacturing costs optimisation
Positive operating cash inflow in line with commercial sales growth, demonstrated through customer receipts of $463.7M (vs. $124.1M in 2022), and
Closing cash balance was $123.2M as at 31 December 2023.
Progress across the core pipeline includes:

First patients dosed in the ProstACT GLOBAL Phase III clinical trial of TLX591, a first-in-class investigational rADC[2] for prostate cancer therapy
Positive interim readout from the ProstACT SELECT Phase I clinical trial reinforcing the differentiation of TLX591, including favourable safety profile and clinical utility of the patient-friendly short dosing regimen
Submission of the Biologics License Application (BLA) for TLX250-CDx (Zircaix[3]) to the United States Food and Drug Administration (U.S. FDA) for kidney cancer imaging on a rolling review basis
Patients dosed in multiple clinical trials of Telix’s therapeutic candidate TLX250 for clear cell renal cell carcinoma (ccRCC) and other solid tumours expressing carbonic anhydrase IX (CAIX)
First cohort of patients dosed in the IPAX-2 trial investigating Telix’s glioblastoma therapy candidate, TLX101, in newly diagnosed patients
Commercialisation plans underway for glioma imaging agent, TLX101-CDx (Pixclara[3]), ahead of the planned submission of a New Drug Application (NDA) to the U.S. FDA in Q1 2024, and
Ethics approval granted to commence biodistribution and safety study of TLX300-CDx, first human study of radiolabelled olaratumab being developed as a therapeutic candidate for soft-tissue sarcoma.
Dr Christian Behrenbruch, Managing Director and Group CEO commented:

"This is an excellent result which demonstrates the strength of the Telix business model. We have achieved profitability while intensively investing in the development of our late-stage assets and the scale-up of our commercial infrastructure and marketing activity. This has resulted in Telix capturing a meaningful market share in the growing urology imaging market whilst laying the foundation for our next commercial products.

"We are highly focused on the development of our theranostic pipeline and vertical integration of supply and manufacturing. This activity is key to diversifying our revenue streams, creates additional value for our therapeutic assets and further differentiates Telix as a fully integrated global radiopharmaceutical company."

Further details on the Company’s results can be found in the Appendix 4E, the accompanying investor presentation, and 2023 Annual Report lodged with the ASX and also available on the Company’s website.

Guidance

Full year revenue for 2024 expected range of US$445M to US$465M ($675M to $705M at current exchange rates), representing an approximate 35-40% increase on 2023.

Revenue guidance is based on worldwide sales of Illuccix, with potential upside from Zircaix[3] (kidney cancer imaging) and Pixclara[3] (glioma imaging), subject to product regulatory approvals. Guidance will be updated throughout the year, as appropriate, to reflect product approvals.

Expected additional investment of 40-50% in R&D (compared with 2023), including both external and internal costs funded by operating cash flow and broadly in line with revenue growth.

2024 R&D investment activity is expected to include validation of commercial manufacturing and market launch activities in preparation for approval of Zircaix[3] and Pixclara[3] a fully operationalised ProstACT GLOBAL therapy trial in prostate cancer, and initiation of additional therapeutic clinical trials, including manufacturing activity, across the broader pipeline. 2024 R&D investment also includes indication expansion and life-cycle management of Illuccix.

Investor call

An investor webcast will be held at 9.00am AEDT on Friday 23 February 2024 (Thursday 22 February 2024, 5.00pm EST)

Participants can register for the webcast and find audio call details at the following link: View Source