Dear Shareholders,
We have a vision to create a truly integrated radiopharmaceutical company, a company enabled by precision medicine and with the development, commercialisation and manufacturing expertise to bring our highly differentiated therapeutics to patients around the world. Our achievements in 2023 have all been delivered with this vision in mind and further solidify Telix’s position as a leader in this rapidly growing field of cancer treatment.
A commercial-stage company, with an expanding product portfolio
In the second year since launching Illuccix®, our commercial-stage diagnostics business has gone from strength to strength, underpinning total revenue growth of 214% from $160.1 million in 2022, to $502.5 million in 2023. We have achieved a meaningful market share in the U.S., estimated at over 30% of the PSMA-PET/CT1 imaging market for prostate cancer. This growth has been driven by our reputation for availability and flexible scheduling, our demonstrated excellence in customer support and increasingly the clear clinical differentiation of Illuccix®. This is an outstanding achievement.
In 2024, we are focused on continuing to grow revenue from Illuccix® in the U.S. and globally in line with increased clinical utilisation and as we secure marketing authorisations in additional geographies. We are also poised to expand our commercial-stage portfolio with the anticipated launch of two new imaging agents, subject to regulatory approvals: Zircaix™2 for kidney cancer imaging and Pixclara™2 for imaging of glioma.
During 2023 we commenced the regulatory filing for Zircaix™,2 with the United States Food and Drug Administration (FDA) under a Biologics License Application (BLA) rolling submission, an important milestone and major achievement for the Company. We will soon file our New Drug Application (NDA) for Pixclara™.2 Both products are supported by strong clinical evidence, have a clear value proposition and potential to address significant unmet need in their respective indications.
The clinical results of the ZIRCON Phase III trial in kidney cancer imaging have been showcased at the world’s leading medical congresses, testament to the groundbreaking trial outcomes of this clinical program. Patients in the U.S. and Europe can now access this important imaging agent in our expanded access and named patient programs, facilitating patient access and addressing unmet medical need whilst regulatory submissions are progressed.
The ability to successfully commercialise our imaging agents is important to our strategy in several ways. Revenue generation provides a significant source of funding towards the development of our therapeutic programs. More strategically, it is the foundation of our integrated precision medicine approach because the ability to precisely quantify disease, guide treatment decisions and select patients for therapy both de-risks and enhances our therapeutic pipeline. You can read more about our strategy in the Forward strategy and operational targets section of this Report.
Delivering on the potential of our pipeline of first-in-class therapeutic assets
We have continued to make significant progress across our extensive clinical-stage therapeutic pipeline, dosing patients in our core therapy programs in prostate, kidney and brain cancer, whilst preparing to launch new studies in bone marrow conditioning (BMC) and soft tissue sarcoma (STS). Our programs are highly differentiated and validated by extensive clinical and pre-clinical data. The progress made in 2023 sets the stage for multiple catalysts and readouts in 2024.
The release of interim data from the ProstACT SELECT trial in late 2023 was an important milestone that enabled us to demonstrate the safety benefits of our first-in-class rADC and lead prostate cancer therapy candidate, TLX591. The rADC approach is highly differentiated from small molecule-based PSMA-targeted therapies in terms of dosing, side-effect profile and, potentially, survival. The ProstACT GLOBAL Phase III trial is now dosing patients at Australian sites and expansion into the U.S. is imminent, subject to regulatory approval. We expect an interim readout from this study in 2025.
Clinical trials are being progressed for our kidney cancer therapy candidate TLX250, which like Zircaix™2 for imaging, targets carbonic anhydrase IX (CAIX). CAIX is a scientifically validated target in clear cell renal cell carcinoma (ccRCC), which is the most prevalent and aggressive form of kidney cancer. We continue to recruit patients into the STARLITE-1 and STARLITE-2 studies, exploring TLX250 in combination with immunotherapies.
Clinical experience and scientific literature support the expanded use of TLX250 in other cancers that express CAIX, including ovarian, triple-negative breast cancer and bladder cancer and our expanded clinical program for TLX250-CDx and TLX250 is evaluating utility as a pan-cancer theranostic pair. In 2023 we commenced dosing patients in the Phase 1b trial, STARSTRUCK, of TLX250 and peposertib (Merck KGaA, Darmstadt, Germany) in patients with ccRCC as well as other selected solid tumours and the STARBURST Phase II trial of TLX250-CDx exploring CAIX expression in patients with a diverse range of solid tumours for potential therapeutic and diagnostic applications. As these trials progress, they will generate important insights and inform our development strategy.
We have continued the evaluation of our brain cancer therapy candidate in the front-line and recurrent disease settings where we have observed promising preliminary clinical evidence of anti-tumour effect and disease stabilisation in glioblastoma, a rare disease. We successfully completed a pre-clinical proof of concept of radiolabelled olaratumab, the antibody we in-licensed from Eli Lilly and Company (Lilly) in 2022, in soft tissue sarcoma. This has generated very promising results and paves the way to commence a clinical trial of TLX300-CDx in this indication.
2024 will be an exciting year for Telix as we deliver on the milestones across these programs and focus on execution as a therapeutic company.
Augmenting our capabilities and pipeline through acquisitions
Telix continues to be differentiated by innovative nuclear medicine solutions spanning the patient treatment continuum from diagnosis, through surgical intervention, to therapy.
To date, this is best demonstrated by our offering in urologic oncology, initially for the treatment of prostate cancer. The acquisition of Lightpoint Medical's business enhances our portfolio with the addition of SENSEI® a miniature gamma probe device used to detect radiation in patients and guide surgery. By delivering molecular imaging solutions to the operating theatre, we will build deeper relationships with key opinion leaders and physicians who use our products, better supporting patients through their cancer journey.
The acquisition of Dedicaid GmbH and its clinical decision support software (CDSS) and AI platform has enhanced our AI capabilities. We believe that AI has an important role to play in increasing efficiency and supporting clinical decision-making in order to maximise the capacity of imaging infrastructure. Advanced image analysis techniques will bridge diagnostic and therapeutic medicine by personalising treatment, further optimising patient outcomes.
We have built a strong global supply, manufacturing and distribution network. This has underpinned the successful launch of Illuccix® and the delivery of many clinical trials. We continue to invest in vertical integration and manufacturing and in 2023 we opened our state-of-the-art radiopharmaceutical production facility in Belgium – one of the largest of its kind in Europe. In addition, the integration of Optimal Tracers has expanded our translational radiochemistry capability and established a U.S.-based laboratory and production footprint for radiopharmaceutical doses to support clinical trials.
Conclusion
I expect 2024 to be a pivotal year in the history of Telix, as we unlock the value in our therapeutic pipeline and continue to impact the lives of patients worldwide, every single day. I thank all of our employees who work so tirelessly, inspired by our purpose to help patients with cancer and rare diseases live longer, better quality lives. To our valued shareholders, we appreciate your ongoing support of the company. We look forward to sharing the next phase of our growth with you.
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Dr Christian Behrenbruch | |
- Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography.
- Trade name subject to final regulatory approval.