Telix Pharmaceuticals Limited

Good morning and good evening everybody. My name is Kyanne Williamson, SVP of Investor Relations and Corporate Communications at Telex and it's my pleasure to welcome you today to our H1 2026 interim results presentation and call. You'll have seen our documents lodged on the ASX earlier this morning. Next slide please. Today on our call we'll be joined by Dr Christian Barenbrook, Managing Director and Group CEO, Darren Smith, our Group Chief Financial Officer, Kevin Richardson, CEO of the Telex Precision Medicine business, and Dr David Cade, Chief Medical Officer. Following prepared remarks, we will open up the call to Q&A, starting with calls on the conference line. If we don't get to your questions during the call, we will respond to you after the call is finished. Please note that today's presentation includes forward-looking statements, including within the meaning of the US Private Securities Litigation Reform Act of 1995 that relate to, among other things, anticipated future events, financial performance, plans, strategies and business developments. These forward-looking statements are based on current information, assumption and expectations of future events that are subject to change and involve risks and uncertainties that may cause the actual results to differ materially from those containing forward-looking statements. These and other risks are described in our filings with the ASX and SEC including our half-year and annual reports. You are cautioned not to rely on these forward-looking statements which are made only as of today's date and the company disclaims any obligation to update such statements. Please refer to the disclaimer slide included in the presentation accompanying this webcast for further information. With that, I'd now like to hand over to Chris.

Thank you very much Kai. Good morning and good evening everyone. Before I go into our strategic priorities for this year, let me take a moment to remind everyone about our competitive advantages and what it takes to lead this field. We are a pure play radiopharmaceutical firm and our strength is based on five core pillars of activity. Firstly, our therapeutic pipeline is highly differentiated and built around significant unmet medical need. We're advancing innovative therapies in areas that have seen little to no innovation for decades, with either first in class or best in class candidates. Our portfolio is diversified with multiple shots on goal, further de-risking commercial success. We've also built in-house R&D capabilities that enable us to develop and optimize both targeting agents and their radioactive radioisotope payload, tailored to the specific biology of each disease. As we've said many times before, we are agnostic to the targeting agent and radioisotope. We let science guide these decisions. We are not wed to a narrative around a specific platform or approach. Earlier this year, we announced a collaboration with Regeneron that combines our expertise in radiopharma with Regeneron's leadership in biologics and antibody engineering. This highly complementary partnership positions us to accelerate the development of next-generation candidates and really puts us in a good place to lead in the therapeutic space in the future. Our precision medicine business is our third core pillar that's generating close to a billion dollars in revenue and enables us to reinvest this significant capital into the business to continue this growth trajectory. The precision medicine business has enabled us to establish a presence across global markets where we continue to strengthen and guide our clinical activity. We've built a specialist commercial organization, a team that represents some of the strongest talent in the industry, and is our fourth core pillar in differentiating us from competition. We've invested and continue to invest in our manufacturing and supply chain capabilities. The RLS transaction last year has significantly strengthened our control over the entire value chain from production and quality assurance to the final dose delivery. It's brought us closer to the customer, enabled us to meet growing demand, and positioned us well to deliver therapeutic solutions down the road. Earlier this year, we shared three areas of focus and I wanted to show the progress we're making against them. On the commercial front, we delivered approximately $390 million in precision medicine sales, up 27% year on year. This is driven by the successful launch of Gazelix and continued growth of Ellucix. We are now tracking towards the upper end of our guidance very close to a billion dollars in revenue. On the regulatory front, we've completed the submissions for PixClara and PixLumi in both the U.S. and Europe, with a PDUFA date now assigned in the U.S. of the 11th of September. In terms of Zyrtex, we received a corrected complete response letter from the FDA, and the resubmission process is tracking against agreed timelines with the agency. We're putting the final touches on the package and ensuring that the resubmission fully addresses all outstanding items before filing, particularly third party manufacturing deficiencies. And this, of course, remains one of our top priorities for the year. On the therapeutics front, we've advanced three phase three candidates with full alignment with the FDA on part two for TLX591, our prostate cancer therapeutic, and started dosing patients for the other programs. And David will go into this in more detail later in the presentation. The bypass biopsy phase three study is close to completing the targeted enrollment. The study has the potential to significantly increase the market and change the treatment paradigm in prostate cancer. And Kevin will share more on this game-changing program later in the presentation. Next slide, please. This slide illustrates our growth since 2024. As you can see, we've continued to develop the business, doubling the revenue since the first half of 2024. and delivered approximately 22% year-on-year growth, really eclipsing the growth of peer firms and recent financial results. We've demonstrated market leadership with two approved and reimbursed products, strong market penetration, and continued commercial execution. This really shows that our strategy works. The strategic transactions and R&D investments we've made are starting to pay off. The acquisition of RLS has also, as I've mentioned, further diversified our revenue streams and allowed us to maintain a stable third-party revenue stream since the acquisition of last year. We are committed to building out full product suite capability of RLS as an independent pharmacy network, including third-party product solutions that benefit from one of the most capable distribution networks in North America. As our global footprint has grown, so has our manufacturing and distribution network. This is particularly important in the field of radiopharma, where the half-lives and shelf-lives products require just-in-time manufacturing and a highly specialized supply chain to avoid disruptions or delays to patients. Last year, we expanded manufacturing and distribution capabilities in the US and Japan, and these are investments that are critical to establish the foundation for a scalable infrastructure in the future. This year, we also opened up our new translational research site in Melbourne. The site offers an integrated platform housing R&D and patient care under one roof, and is designed to accelerate the development and delivery of theranostics through rapid de-risking and proof-of-concept development. And this is really a capability that's unlike any other found elsewhere. We continue to make CapEx investments at various sites, including CNES, Yokohama, and at RLS. where we're building out the manufacturing capabilities for therapeutics delivery, very important clearly to our next phase of growth. This includes increasing clean room capacity, installing cyclotrons, and making sure that the RLS network is equipped and licensed to do things like dispense lutetium therapeutics drugs. With that, I'll hand over to our CFO, Darren Smith, who will provide an update on the financials. Over to you, Darren.

Thank you, Chris, and hello, everyone. Moving to the financials for the first half of this year. We reported revenue of $477 million, up 22% compared to the first half of 25. This was achieved through robust commercial execution that delivered strong demand on our precision medicine products. Kevin will speak to this later in the presentation. EBITDA improved 146% year-on-year to $52 million. and net profit after tax was up to $38 million, reflecting strong business performance in continued control of operating expenditure. Our R&D investments represented 26% of our revenue, focused on accelerating near-term growth opportunities and developing our late-stage assets. Gross margin for our precision medicine business was 65%, an improvement of 1% year-on-year. We also successfully increased our cash balance to $252 million for the refinance of our convertible bonds, a successful transaction with better terms. We are well placed with the financial capacity to accelerate growth. Next slide, please, and turning to our income statement. As previously mentioned, we delivered double-digit growth both on the top line and the bottom line of our group P&L. Gross margins for the consolidated group improved 2% to 55%. This was supported by our strong growth on the top line and we continued our healthy investment into our product development pipeline with a focus on near-term commercial opportunities and phase three clinical studies for a number of our therapeutic candidates. At the same time, we have maintained a disciplined approach to managing our operating expenditure, reducing it by 1% as a percentage of sales. Next slide, please. Moving to our thank you diagram, this clearly illustrates how we generate our funds and how they flow through the business. On the left side of the chart, it shows that in the first half of 2026, Telex generated revenue and income of $523 million from our Precision Medicine business, CMS and Regeneron Collaboration. The middle sections of the chart show that after covering cost of sales, OPEX and finance costs, Tealix reported a commercial profit of $153 million, a 29% return on revenue and income generated, demonstrating the strength of the business. I want to reiterate that we have a highly profitable business with strong cash generating capabilities, but as we have said many times, rather than maximising near-term earnings, we are reinvesting capital into growth opportunities that will drive long-term shareholder value. We continue investing our earnings into the business for the remainder of this year and the next year. From this financial position, and as illustrated on the right side of this thank you graph, we have made a decision on how much we invest into our R&D development and how much we bank as profit. Again, I cannot overstate the importance of the investment we are making today and the significant value that will drive in the long term. Next slide, please. A precision medicine business continues to deliver double-digit growth, up 27% year-on-year from our differentiated products. Both Ellucix and Gazelix continue to drive strong demand across all market segments. Kevin will comment on this later. Gross margins of 65% improved 1% year-on-year, driven by a disciplined pricing in manufacturing and distribution efficiencies. R&D investment increased year on year driven by PixClara, Zikaix and Bypass investments that will drive meaningful commercial uptake near term. As Chris mentioned, we are significantly expanding our market across our portfolio, including prostate cancer imaging with Bypass, brain metastasis imaging from PixClara and renal mass imaging with the CAGs. Overall, that is in excess of one million scans that our customers will meaningfully benefit from. EBITDA grew 26% year on year to $132 million. While we expect healthy EBITDA growth to remain, we remain committed to reinvesting the capital into the business in our pipeline, as I've mentioned earlier. Now moving to TMS. CMS generated third party revenues of $89 million, up 10% year on year by RLS. Since the acquisition of RLS, we have maintained a stable base of third party revenue, further diversifying our revenue streams. We have also successfully been driving manufacturing and supply chain efficiencies for RLS by selling a higher proportion of our own assets through them. Internal revenues of $57 million, improved 70% year-on-year, representing Illusix and Gazelix distributed for RLS. This means RLS is now our second largest distributor of our products. We also continue to invest in our manufacturing sites at CNEF, Yokohama, and selected RLS sites to ensure the global readiness to deliver our precision medicine and therapeutic candidates. Next slide, please. Our full-year revenue guidance of between $950 and $970 million is maintained for 2026. We do, however, expect that to land at the upper end of the range. And we expect continued growth in excess of 20% year-on-year of our precision medicine business. Please note, our full-time guidance does not reflect unapproved products, providing the potential for upside. We updated our R&D guidance to a range of $230 to $270 million, primarily reflecting new investment across the development program discussed today, as well as our collaboration with Regeneron. Given the strength of our commercial business, we believe that we are well positioned to support and accelerate near-term growth. I'll now hand you over to Kevin Richardson, Precision Medicine CEO.