Telix Pharmaceuticals (NASDAQ:TLX) outlined its commercial imaging franchise, regulatory plans for two radiodiagnostic candidates, and progress across a broad therapeutic radiopharmaceutical pipeline during a discussion at Oppenheimer’s Annual Healthcare Conference with CEO Christian Behrenbruch.
Company scale and business mix
Behrenbruch said Telix is dual listed on the ASX and NASDAQ and expects to generate “just under $1 billion” in revenue this year, primarily from its “precision medicine” imaging business. He described Telix as commercially active in 26 countries with a “very international workforce.”
Prostate imaging: Illuccix and Gozellix positioning
Telix’s flagship prostate imaging agent Illuccix launched in 2021 and targets PSMA. Behrenbruch said Telix came to market shortly after a larger competitor and has worked to take what he characterized as a “fair share” of the market. He noted Illuccix came off transitional pass-through reimbursement at the end of the second quarter of last year.
He described Gozellix as a lifecycle management product for Illuccix that received pass-through reimbursement in October, providing what he called a “three-year run” in the CMS HOPPS segment. Behrenbruch said Gozellix is not simply a reformulation, citing clinical and logistical advantages including cyclotron-based solid target production, higher activity generators, and a different formulation that enables a “three-times longer shelf life.” He said the longer shelf life supports both high-volume deliveries to academic centers and broader last-mile delivery into areas with limited radiopharmaceutical access.
Behrenbruch also framed Telix’s commercial approach as a “two-track” strategy: using Illuccix to compete aggressively in commercial contracting while using the reimbursed pathway for Gozellix to avoid “price erosion” in the reimbursed segment. He said the market is now heavily driven by GPO and IDN contracts.
BiPASS study aims to expand the PSMA PET market
Behrenbruch said Telix continues to see a need for education among urologists around PSMA PET, while also emphasizing a broader urology strategy that includes surgical tools and a renal cancer imaging product “very close to being available.” He noted urologists are increasingly buying PET scanners to participate more directly in the patient journey, and said Telix’s pharmacy network supports closer service relationships.
On market growth, Behrenbruch said he believes prostate imaging growth estimates of 2%–3% annually are “underbaked” and suggested growth is more like 5%–7% a year. He also highlighted label expansion opportunities tied to Telix’s BiPASS biopsy study, which he said is recruiting “extremely fast,” is about halfway enrolled, and is expected to finish recruitment around May or June.
BiPASS is designed to evaluate whether PET imaging can help triage patients and reduce unnecessary biopsies. Behrenbruch cited roughly 1.2 million prostate biopsies per year in the U.S. and said about 800,000 are “not additive to patient management.” He said the current U.S. addressable market is about 650,000–700,000 scans annually and that BiPASS could add another 800,000 scans, potentially doubling the market. He also argued that scanning patients earlier could influence long-term market share by establishing longitudinal imaging comparisons over a patient’s disease course.
Asked about PET capacity, Behrenbruch said demand is increasing across prostate cancer, new disease areas such as FAP, neuroendocrine imaging, and emerging PET use in dementia and cardiology. He said more scanners are being installed and noted improvements in scanner sensitivity and workflow, including AI-enabled reductions in scan time. He emphasized that patient throughput and community-based access are increasingly important, which he tied back to Telix’s nuclear pharmacy footprint and partnerships with large networks such as Cardinal Health.
Regulatory updates: Pixclara and Zircaix resubmissions
Behrenbruch said Telix received two complete response letters (CRLs) last year for its glioma and renal imaging products. He stated that Pixclara is expected to be resubmitted “in the next few days,” and that Telix has filed its European submission and chose to harmonize U.S. and EU filings with a single CMC package and consistent clinical references.
He said Zircaix would follow “a couple of months behind” and that Telix held two Type A meetings with the FDA to review CMC deficiencies. Behrenbruch said the company believes Pixclara “should have been approved,” describing the situation as a “change in goalposts,” while also saying the FDA had been collaborative regarding statistical analysis changes. For Zircaix, he said Telix initially approached it like a PET imaging drug, while the FDA viewed it more like a biologic drug conjugate, calling it “the first time anybody submitted a PET biologic to the FDA.” Behrenbruch said the agency was “highly supportive” of approval and that he still expects Zircaix to launch this year, with the resubmission targeted for the current half.
Therapeutics pipeline: TLX591 and renal cell therapy strategy
Behrenbruch said Telix typically develops both an imaging agent and a therapeutic for each target, using imaging to validate target expression and support patient selection and dosimetry.
He provided an update on TLX591 (lutetium-177 antibody program) in a Phase III study outside the U.S. He said the trial has progressed into the randomized portion following a seamless transition from Part One (a run-in) to Part Two. The run-in was requested by the FDA to compare safety between androgen receptor pathway inhibitor (ARP) combinations, particularly enzalutamide and abiraterone, which Behrenbruch said are central to RP-switch practice in the U.S. but less so outside the U.S. He attributed delays in releasing Part One data to CRO closeout and the demanding nature of repeat imaging and dosimetry, and said results would be available “very shortly.” He also noted an independent data safety review board reviewed the data late last year, allowing progression to randomization ex-U.S.
Behrenbruch said Part Two is enrolling faster due to a more straightforward protocol. He highlighted a short-course dosing regimen—two administrations 14 days apart—at a lower dose. On differentiation versus existing PSMA radioligand therapy, he said regulators have made clear that overall survival is the key endpoint, and noted Telix expects a futility analysis on PFS later this year (around Q4) based on approximately 80–90 events.
In renal cancer therapeutics, Behrenbruch discussed the CA9-targeting approach tied to Zircaix imaging. He said Telix selected an antibody platform for both imaging and therapy to avoid urinary excretion and achieve clearer metastatic staging. He said a Phase III therapeutic study in clear cell renal cell carcinoma is “getting ready to kick off,” and described the design of the LUTEON study as closely modeled on the VISION trial concept, but in a late-line clear cell renal cell population. He said the goal is to establish an initial monotherapy signal and “a commercial foot in the door,” while running parallel combination studies including cabozantinib and nivolumab, citing a rationale for combining checkpoint inhibitors with targeted radiation.
About Telix Pharmaceuticals (NASDAQ:TLX)
Telix Pharmaceuticals (NASDAQ: TLX) is a clinical-stage biopharmaceutical company focused on the development and commercialization of molecularly targeted radiopharmaceuticals for the diagnosis and treatment of cancer. Leveraging expertise in radiochemistry, nuclear medicine and oncology, Telix aims to address unmet clinical needs across a range of tumor types by pairing diagnostic imaging agents with therapeutic radionuclides.
The company’s pipeline spans both imaging and therapeutic candidates.
