TLX

Core Competitive Advantages

• Telix is a pure-play radiopharmaceutical firm with five differentiating core pillars: (1) a diversified, first/best-in-class therapeutic pipeline targeting large unmet medical needs; (2) in-house R&D capabilities with targeting/radioisotope agnosticism, anchored by a 2026 collaboration with Regeneron to accelerate next-generation candidate development; (3) a profitable Precision Medicine business generating close to $1 billion in annual revenue that funds pipeline reinvestment and builds global commercial infrastructure; (4) a specialized, industry-leading commercial organization; (5) expanded end-to-end manufacturing and supply chain control following the 2025 RLS acquisition, enabling scalable growth and improved customer access.

Commercial Progress

• Precision Medicine delivered 27% year-on-year H1 growth driven by Illuccix and the successful launch of Gozellix, with consecutive quarterly growth and 16 straight quarters of increasing unit and revenue share. Q2 2026 Precision Medicine revenue was $202 million, up 9% quarter-over-quarter.
• The PSMA portfolio is launched or initiated across 24 countries; NDAs are in preparation/submission in China and Japan, two large markets that will support long-term growth and future therapeutic launches.
• Regulatory submissions for Pixclara (U.S./Europe) and Pixlumi (U.S./Europe) are complete, with a September 11 PDUFA date assigned for Pixclara in the U.S. Pixclara is already included in NCCN and international clinical guidelines, with an additional IND submitted for the larger brain metastasis indication.
• The BiPASS Phase III study for pre-biopsy PSMA imaging is near completion of targeted enrollment; BiPASS could double the existing PSMA imaging market by creating a new pre-biopsy segment and redefining prostate cancer diagnostic pathways.

Pipeline and Therapeutic Development

• Three Phase III therapeutic candidates are advancing: FDA alignment is secured on Part 2 of the TLX591 (ProstACT Global) Phase III trial for metastatic castrate-resistant prostate cancer, with Part 2 enrollment ongoing in seven countries; patient dosing has started for TLX101 (IPAX BrIGHT Phase III for glioblastoma) and TLX250 (LUTEON Phase III for renal cell carcinoma).
• TLX597, a next-generation small molecule radioligand therapy, has completed enrollment in the OPTIMAL-PSMA Phase II trial and started dosing in the OPTIMAL-e Phase II trial for earlier-stage metastatic hormone-sensitive prostate cancer, with a favorable dosimetry profile (high tumor dose, low healthy organ dose).
• Telix's theranostic paired development model (developing an imaging agent for every therapeutic candidate) reduces therapeutic development risk by generating key biodistribution and target selectivity data before large-scale late-stage investment.

Infrastructure Expansion

• Manufacturing and distribution capabilities have been expanded in the U.S. and Japan; a new integrated translational research site opened in Melbourne to accelerate theranostic development; CapEx investments are ongoing at Seneffe, Yokohama, and RLS sites to add clean room capacity, cyclotrons, and lutetium therapeutic dispensing licensing to support future therapeutic launches.

• Full year 2026 total revenue guidance is maintained at $950 million to $970 million, with management expecting full year results to land at the upper end of the range. Full year 2026 Precision Medicine revenue growth is expected to exceed 20% year-on-year.
• Full year 2026 R&D guidance has been updated to a range of $230 million to $270 million, reflecting increased investment in ongoing development programs and the Regeneron collaboration.
• Guidance does not include revenue from unapproved products, creating potential upside if near-term regulatory approvals are secured.

Consolidated group: Total revenue was $477 million, up 22% year-on-year; consolidated gross margin improved 2% to 55%; EBITDA was $52 million, up 146% year-on-year; net profit after tax was $38 million; R&D investments represented 26% of total revenue; ending cash balance was $252 million. Precision Medicine segment: H1 2026 revenue was approximately $390 million, up 27% year-on-year; gross margin was 65%, up 1% year-on-year; EBITDA grew 26% year-on-year to $132 million; revenue contribution is approximately 82% of total consolidated H1 2026 revenue. TMS (RLS) segment: Third-party revenue was $89 million, up 10% year-on-year; internal revenue (distributing Telix's own products) was $57 million, up 70% year-on-year; total segment revenue was $146 million, representing approximately 31% of total consolidated H1 2026 revenue.

• Forward-looking statements (including guidance, pipeline progress, and launch timelines) are inherently uncertain, and actual results may differ materially from expectations due to regulatory, clinical, and market risks.
• Zircaix previously received a complete response letter from the FDA related to third-party manufacturing deficiencies, requiring resubmission that adds timing uncertainty to its potential approval.
• Clinical trial outcomes, regulatory review timelines, and market adoption of new products are inherently uncertain, and competitors' new product launches could impact Telix's market share.
• Radiopharmaceutical products require specialized just-in-time manufacturing and supply chains, creating inherent disruption risk if infrastructure does not scale as expected.

Q: How will the upcoming October 2026 reimbursement activation for competitor Lantheus' TruVu impact Telix's PSMA imaging market share for the remainder of 2026? / A: Management does not expect TruVu to have a material impact on Telix's market share. TruVu is positioned primarily as a manufacturing improvement rather than a differentiated product with a segmented market strategy, unlike Telix's successful two-product Illuccix/Gozellix approach. Existing guidance already incorporates realistic expectations for competitor activity, and no changes to strategy or guidance have been made.

Q: When will Zircaix be resubmitted to the FDA, and how much control does Telix have over the resubmission timeline? Is the extended timeline connected to the prior FDA administrative issue with the corrected complete response letter? / A: Management confirms full control over the resubmission process, and a resubmission in the next 1-2 months is a reasonable expectation. The extended timing is unconnected to the prior FDA administrative error that delayed release of the corrected complete response letter; no new regulatory restrictions were added, and Telix retains flexibility on the resubmission date.

Q: Why was BiPASS trial enrollment target increased, and what has physician feedback been during enrollment? What is the planned scope of use if approved? / A: The enrollment increase was not due to insufficient initial statistical power, but rather to accommodate unexpectedly rapid site onboarding and patient backlog that the team elected to fulfill, with collaborative alignment with the FDA. Physician enthusiasm has been very high, with extremely rapid enrollment driven by clinician belief that adding PSMA PET to MRI improves biopsy decision-making. The trial enrolls PI-RADS 1-4 patients, with the goal of reducing unnecessary biopsies and shifting to targeted biopsies when needed; the FDA will consider the totality of data covering all enrolled patient populations for approval.

Q: What is management's perspective on negative industry commentary about antibody-based radiopharmaceuticals, and how will the Lantheus-Curium merger impact Telix's strategy? / A: Management notes that most negative bias against antibody modalities stems from historical academic resource constraints rather than clinical data; Telix's agnostic approach means it only invests in antibody candidates when data supports their merit, and a deeper dive on this topic will be provided at the September R&D Day. The merger does not change Telix's strategy; management views it as business as usual, and does not see it altering the competitive landscape in a material way for Telix.