Telix Pharmaceuticals (NASDAQ:TLX) reported first-half 2026 revenue of $477 million, up 22% from the prior-year period, as demand for its precision medicine imaging products continued to grow. The company said EBITDA increased 146% year over year to $52 million, while net profit after tax rose to $38 million.
Managing Director and Group CEO Dr. Christian Behrenbruch said the company generated approximately AUD 390 million in precision medicine sales, a 27% increase from a year earlier, driven by the launch of Gozellix and continued growth in Illuccix. Telix said it is tracking toward the upper end of its full-year revenue guidance of AUD 950 million to AUD 970 million.
Financial performance and investment
The company increased its cash balance to $252 million following a refinancing of its convertible bonds. Smith said Telix is prioritizing reinvestment in development programs rather than maximizing near-term earnings.
Research and development spending represented 26% of revenue in the first half. Telix updated its 2026 R&D guidance to AUD 230 million to AUD 270 million, citing additional investment in development programs and its collaboration with Regeneron.
- Precision medicine EBITDA rose 26% year over year to AUD 132 million.
- Telix Manufacturing Solutions, including RLS, generated AUD 89 million in third-party revenue, up 10% year over year.
- Internal revenue distributed through RLS increased 70% to AUD 57 million, making RLS Telix’s second-largest distributor of its products, according to Smith.
Telix said it continues to invest in manufacturing and distribution capacity at facilities in Seneffe, Yokohama and selected RLS sites. The investments include clean-room capacity, cyclotrons and capabilities needed to dispense lutetium therapeutic drugs.
Imaging portfolio expands internationally
Kevin Richardson, CEO of Telix Precision Medicine, said the company’s prostate-specific membrane antigen, or PSMA, imaging portfolio has gained unit and revenue market share for 16 consecutive quarters. Revenue from the portfolio totaled $202 million in the second quarter, up 9% sequentially, following $186 million in the first quarter.
Richardson said Telix’s two-product strategy, centered on Illuccix and Gozellix, was designed to serve different customer segments. He said the products’ clinical characteristics, service reliability, ordering process, pricing consistency and physician education efforts have supported adoption.
Telix has launched or initiated launches of its PSMA portfolio in 24 countries. In China, the company submitted a new drug application earlier this year and is awaiting review by the National Medical Products Administration. In Japan, Telix completed enrollment of more than 100 patients in a registration-enabling study and is preparing an NDA submission while awaiting feedback regarding conditional approval.
On the regulatory front, Telix said the U.S. Food and Drug Administration assigned a Sept. 11 PDUFA date for Pixclara, while the company has also submitted Pixlumi in Europe. Behrenbruch said the European review process generally takes about 18 months from submission, although timing can vary based on review periods and clock stops.
For Zircaix, Telix received a corrected Complete Response Letter from the FDA and said it is finalizing a resubmission package, particularly addressing third-party manufacturing deficiencies. Behrenbruch said a resubmission in the next one to two months would be a reasonable assumption and that the timing is within the company’s control.
BiPASS study nears enrollment target
Telix said its Phase III BiPASS study is close to completing targeted enrollment. The trial is evaluating the potential use of PSMA PET imaging before prostate biopsy, an application that Richardson said could approximately double the current PSMA imaging market if successful.
The company said approximately 800,000 prostate biopsies are performed annually in the U.S., with roughly 75% producing negative results. Richardson said BiPASS could reduce unnecessary biopsies and improve confidence for patients who proceed to the procedure.
Chief Medical Officer Dr. David Cade said the study enrolled rapidly, with approximately 350 patients recruited in about five months. He said early investigator experience indicated interest in using gallium PSMA PET imaging alongside MRI to inform whether a biopsy is needed and, when appropriate, what type of biopsy should be conducted.
Cade said BiPASS enrolled patients with PI-RADS scores from 1 through 4, but not PI-RADS 5, under an agreement with the FDA. He described the program’s objective as potentially reducing the number of biopsies while maintaining detection of clinically significant prostate cancer.
Therapeutic pipeline progress
Telix said the FDA completed its safety review of Part 1 of the Phase III ProstACT Global study of TLX591 in metastatic castrate-resistant prostate cancer. The company said it has aligned with the FDA on the Part 2 protocol design and expects another FDA engagement before filing an amended investigational new drug application.
The company is enrolling ProstACT Global patients in seven countries and plans to provide an update when an event-driven interim analysis of radiographic progression-free survival becomes available. The analysis requires 81 disease-progression events.
Telix also said it has completed enrollment in the Phase II OPTIMAL-PSMA study of TLX597 in metastatic castrate-resistant prostate cancer and has begun dosing patients in the OPTIMAL-e study in metastatic hormone-sensitive prostate cancer. The company is also dosing patients in its Phase III IPAX-BrIGHT study of TLX101 plus lomustine in glioblastoma and in a renal cell carcinoma study involving a CAIX-targeting antibody therapy.
Behrenbruch said Telix will host an R&D Day in New York on Sept. 22 to provide further detail on its pipeline and clinical data.
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.
