TELIX Pharmaceuticals Ltd Posts Record US$247M Q2 Revenue, FY Outlook Tops US$1B

Telix delivers Q2 2026 revenue of US$247M, lifts full-year outlook above US$1 billion

In its Q2 2026 quarterly update, Telix Pharmaceuticals reported group revenue of US$247 million for the quarter ended 30 June 2026, up 7% quarter-on-quarter (QoQ) and 21% year-on-year (YoY).

The commercial-stage global radiopharmaceutical company now expects FY 2026 revenue and other income to exceed US$1 billion, with revenue tracking in line with the upper end of its US$950 million to US$970 million guidance, plus US$40 million in non-refundable other income received from Regeneron.

Dual-listed on the ASX and NASDAQ (both under ticker TLX), Telix combined commercial strength with a series of regulatory, clinical and corporate milestones across the reporting period.

Q2 2026 revenue performance

Precision Medicine remained the primary growth engine, recording revenue of US$202 million, up 9% QoQ and 30% YoY, driven by sales of Illuccix and Gozellix. The company noted U.S. dose volumes increased 7% during the quarter, supported by growing demand for Gozellix and continued strength across its PSMA imaging portfolio.

Telix Manufacturing Solutions (TMS) revenue came in at US$45 million, down 6% YoY but up 2% QoQ.

Dr. Christian Behrenbruch, Managing Director and Group CEO

“We delivered another quarter of growth with U.S. dose volumes increasing 7% during the quarter, driven by growing demand for Gozellix and continued strength across our PSMA imaging portfolio. 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. During the quarter, we achieved key regulatory, commercial and clinical milestones across both our Precision Medicine and Therapeutics businesses. We are tracking in line with the upper end of our FY 2026 revenue guidance and are investing further in R&D to accelerate a number of high-value programs that have the potential to create significant future growth and shareholder value.”

What is radiopharmaceutical theranostics?

Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. PSMA (prostate-specific membrane antigen) imaging works by identifying a target found on prostate cancer cells, allowing clinicians to locate disease using a PET/CT scan.

For investors, the significance lies in the model itself. Telix’s diagnostic franchise, anchored by Illuccix and Gozellix, generates the cash that funds its late-stage therapeutic pipeline. Only Illuccix and Gozellix currently hold marketing authorisation; all other products named remain investigational.

Pipeline momentum across therapeutics and precision medicine

Therapeutics pipeline advances

1. TLX591-Tx (prostate): The FDA confirmed that safety data from Part 1 of the ProstACT Global Phase 3 study is sufficient to enable progression to Part 2 in the U.S., with alignment reached on the 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. Part 2 continues to enrol in Australia, New Zealand, Canada, Türkiye, the UK, Singapore and South Korea, and has received regulatory approval to commence in China.

The ProstACT Global trial‘s FDA alignment covers the complete Part 2 framework, including the clinical protocol, statistical analysis plan, and ongoing safety monitoring approach, following clean Part 1 data across all 36 patients with no new safety signals and a differentiated hepatobiliary clearance profile that distinguishes TLX591-Tx from first-generation PSMA-targeted therapies.

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

3. TLX250-Tx (kidney/ccRCC): The first patient has been dosed in LUTEON, a pivotal trial, with Part 1 expected to enrol up to 40 patients.

4. TLX101-Tx (glioblastoma): The first patient cohort has been enrolled in Part 1 of the IPAX BrIGHT pivotal trial, while enrollment in the IPAX-2 Phase 1 study has completed with no dose-limiting toxicities observed to date.

Precision Medicine regulatory progress

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

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

• Pixclara® (TLX101-Px): The FDA has accepted the resubmitted NDA with a PDUFA goal date of 11 September 2026. A new IND has been submitted for a brain metastases indication expansion, and the European MAA (Pixlumi®) has been validated and accepted for review.

• Zircaix® (TLX250-Px): The BLA resubmission is progressing, with final Chemistry, Manufacturing and Controls (CMC) documentation nearing completion and Breakthrough Therapy designation maintained.

Manufacturing expansion and corporate developments

Telix Manufacturing Solutions (TMS) scales globally

• Opened TMS North Melbourne in partnership with the Melbourne Theranostic Innovation Centre (MTIC), a purpose-built facility combining radiochemistry laboratories, clinical product manufacturing, patient dosing and imaging.

• TMS Brussels South completed its first GMP production run of a lutetium-based therapeutic candidate.

• Installed ARTMS’ QUANTM® Irradiation System (QIS®) at TMS Yokohama to enable local Zirconium-89 production, advancing toward the company’s target of 50 QIS® installations globally by the end of 2026.

Regeneron collaboration, refinancing and Board expansion

Telix entered a strategic collaboration with Regeneron to jointly develop and commercialise 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.

The Regeneron radiopharmaceutical partnership extends well beyond the upfront payment, with up to US$2.1 billion in potential milestones across eight biologics-based programmes if Telix opts out of co-funding, plus a 50/50 profit-sharing structure on any programmes it chooses to co-develop.

The company also 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 capital structure.

As part of Board expansion and succession planning, three new Non-Executive Directors, David Gill, Maria Rivas, MD, and William Jellison, joined the Board effective 11 May 2026.

FY 2026 guidance and the investment case

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

The guidance reflects product sales in jurisdictions with a marketing authorisation and a full year of revenue contribution from RLS.

The company updated its FY 2026 R&D expenditure guidance to US$230 million to US$270 million, subject to achieving ongoing global clinical data outcomes and development milestones. This additional investment, enabled partly by the Regeneron US$40 million payment, is intended to accelerate the TLX597-Tx programme, label expansion for Pixclara® and progression of the Regeneron collaboration.

The quarter positioned Telix with a cash-generative diagnostics franchise funding a deep late-stage therapeutic pipeline. Combined with the Regeneron collaboration and the completed refinancing, the company reported a strengthened balance sheet to support its long-term growth strategy.

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