Telix Pharmaceuticals Ltd Posts US$247M Q2 Revenue as FY Outlook Tops US$1B

Telix delivers US$247M in Q2 revenue as FY 2026 guidance lifts above US$1 billion

In its Q2 2026 quarterly update, Telix Pharmaceuticals recorded Group revenue of US$247 million for the quarter ended June 30, 2026, up 7% quarter-on-quarter and 21% year-on-year.

The result was driven by continued strength in the company’s Precision Medicine business and a series of regulatory and clinical milestones across its therapeutics pipeline. Telix now expects FY 2026 revenue and other income in excess of US$1 billion, with revenue tracking to the upper end of guidance.

Q2 2026 revenue results

Precision Medicine remained the standout driver, delivering revenue of US$202 million, up 9% quarter-on-quarter and 30% year-on-year. This segment primarily reflects sales of the company’s PSMA imaging products, Illuccix and Gozellix.

Telix Manufacturing Solutions (TMS) third-party revenue reached US$45 million for the quarter, down 6% year-on-year but up 2% quarter-on-quarter.

Managing Director and Group CEO Dr Christian Behrenbruch noted that U.S. dose volumes increased 7% during the quarter, driven by growing demand for Gozellix and continued strength across the PSMA imaging portfolio.

Dr Christian Behrenbruch, Managing Director and Group CEO

“This performance underscores the strength of our differentiated two-product PSMA imaging strategy and reinforces Telix’s market leadership, built on clinical differentiation, supply chain resilience and commercial execution.”

What is radiopharmaceutical theranostics?

Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat cancer. In practice, it allows clinicians to first locate a tumour using imaging, then treat it with a therapy that targets the same disease marker.

PSMA imaging works by targeting the prostate-specific membrane antigen, a protein found on prostate cancer cells, to help locate the disease using scans. This is why Telix’s two-product PSMA imaging franchise, comprising Illuccix and Gozellix, underpins current revenue, while the therapeutic pipeline represents the next potential growth leg.

Pipeline milestones across therapeutics and precision medicine

Therapeutics pipeline progress

Telix reported a series of regulatory and clinical advances across its therapeutics candidates during the quarter:

• TLX591-Tx: The FDA confirmed that Part 1 safety data is sufficient to advance the ProstACT Global Phase 3 study to Part 2 in the U.S. The FDA and Telix also reached alignment on the Part 2 clinical trial protocol, statistical analysis plan and ongoing safety monitoring plan. Initiation of Part 2 in the U.S. remains subject to the FDA’s review of an Investigational New Drug (IND) amendment.

• TLX597-Tx: The OPTIMAL-PSMA study completed patient enrollment of 120 patients, and the first patients have been dosed in the OPTIMAL-e Phase 2 study.

• TLX250-Tx: The first patient was dosed in LUTEON, a pivotal trial evaluating the candidate in advanced clear cell renal cell carcinoma (ccRCC).

• TLX101-Tx: The first patient cohort was enrolled in Part 1 of IPAX-BrIGHT for recurrent glioblastoma, while enrollment in the IPAX-2 Phase 1 study was completed with no dose-limiting toxicities observed to date.

For investors wanting to understand the regulatory pathway in depth, our full explainer on the ProstACT Global FDA alignment covers the Type B meeting outcome, TLX591-Tx’s differentiated liver-based clearance profile, and the specific IND amendment filing steps required before U.S. Part 2 enrollment can begin.

Precision Medicine and regulatory progress

Progress across the Precision Medicine business unit included:

• BiPASS™: Rapid enrollment of 338 patients in the Phase 3 study of Illuccix and Gozellix for initial prostate cancer diagnosis in the pre-biopsy setting, with enrollment nearing completion. The study is intended to support regulatory submissions in the U.S., Europe and Australia.

• Japan: Phase 3 enrollment was completed for TLX591-Px (Illuccix), with an NDA in preparation and a Conditional Approval application under review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

• Pixclara®: The FDA accepted the resubmitted NDA and granted a PDUFA goal date of September 11, 2026. The Marketing Authorization Application (MAA) for Pixlumi® in Europe has been validated and accepted for review.

• Zircaix®: The Biologics License Application (BLA) resubmission in the U.S. is progressing, with final Chemistry, Manufacturing and Controls (CMC) documentation nearing completion.

Investors should note that only Illuccix (available in 22 countries) and Gozellix (U.S. FDA approved) currently hold marketing authorization. No other product mentioned above has received regulatory approval in any jurisdiction.

Regeneron collaboration, refinancing and manufacturing expansion

During the quarter, Telix entered into a strategic collaboration with Regeneron to “jointly develop and commercialize next-generation radiopharmaceutical therapies,” initially focused on lung cancer. On execution of the agreement, Telix received an initial non-refundable payment of US$40 million, which is accounted for as other income and is separate from product revenue.

The Regeneron radiopharmaceutical partnership carries a broader financial structure beyond the upfront payment, with up to US$2.1 billion in potential milestones across eight programmes if Telix opts out of co-funding in favour of milestone payments and royalties.

Separately, the company completed a refinancing of its convertible bond structure, issuing US$600 million of new convertible bonds due 2031 and repurchasing all outstanding 2029 convertible bonds. The transaction extends debt maturities and strengthens the company’s capital structure.

On the manufacturing front, TMS continued to expand its global operations:

• Opened TMS North Melbourne in partnership with the Melbourne Theranostic Innovation Centre (MTIC).

• Completed the first GMP production run of a lutetium-based therapeutic candidate at TMS Brussels South.

• Installed the QUANTM® Irradiation System (QIS®) at TMS Yokohama, progressing towards the company’s target of 50 QIS® installations globally by the end of 2026.

Telix also appointed three new Non-Executive Directors, effective May 11, 2026: David Gill, Maria Rivas MD, and William Jellison.

FY 2026 guidance and the investment outlook

Telix expects FY 2026 revenue and other income to be in excess of US$1 billion. This comprises revenue tracking in line with the upper end of the US$950 million to US$970 million guidance range, plus US$40 million in non-refundable other income received from Regeneron.

The company has updated its FY 2026 R&D expenditure guidance to US$230 million to US$270 million, enabled by strong commercial performance and the Regeneron payment. Management indicated the additional investment will support acceleration of the TLX597-Tx program, label expansion for Pixclara®, and progression of the Regeneron collaboration.

For investors, the quarter illustrates a commercial revenue base that is helping fund an expanding late-stage pipeline. Several near-term regulatory catalysts remain on the horizon, including the Pixclara® PDUFA goal date of September 11, 2026, the Zircaix® BLA resubmission, and the Japan NDA for Illuccix.

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