TLX

Good day, and thank you for standing by. Welcome to the Telix Full Year 2025 Results and Investor Webcast. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Kyahn Williamson, SVP of Investor Relations and Corporate Communications. Please go ahead.

Thank you, and thank you to everybody for joining us on this call this morning, this evening, wherever you are in the world. We launched our annual report and full year results on the ASX about 30 minutes ago. We also have the slides on the screen via webcast for you to see today. I'm just going to take you through a brief introduction and some disclaimer statements before handing over. If you just move to the Slide 2. Very pleased to have on the call with us today, Chris Behrenbruch, our CEO and Managing Director; Darren Smith, our CFO; and Kevin Richardson, our CEO of the Precision Medicine business. I should also mention that we have Dr. David Cade, our Chief Medical Officer, on the line for the Q&A session. We'll be running through today our strategy, financial results, and update on our Precision Medicine and Therapeutics business. If you can move to the next slide, please. I am required just to give you an excerpt from our forward-looking statement disclaimer statement. So please note that on today's presentation includes forward-looking statements, including within the meaning of the U.S. 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, assumptions and expectations of future events that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our filings with the ASX and SEC, including on our half year annual report. You are cautioned not to rely on forward-looking statements, which are made only as today's date, and the company disclaims any obligation to update such statements. Please refer to the disclaimer slide in the presentation for further information. With that, I'm very pleased to hand over to Chris to kick off the call.

Thanks very much, Kyahn, and I hope that my audio is nice and clear, and I certainly appreciate the introduction. Before Darren Smith, our Chief Financial Officer, goes into the numbers, I thought a bit of strategic framing would be useful for investors to understand where the company is heading and, of course, our key accomplishments in 2025. Next slide, please, Slide 5. Over the last 12 months, we started to put the depth and execution around what has been a multiyear corporate development strategy. It's useful to think of Telix as a platform with these 5 major segments, as illustrated on this slide. Moving from left to right, first up of key focus is our therapeutics pipeline, which has grown significantly and now features 3 programs in pivotal studies, as well as several high potential earlier-stage programs in rare diseases. I'm going to come back a little bit towards the end of the presentation on this topic. Because of the explosive growth of activity in the radiopharma landscape, we have also pivoted to some extent to an internal innovation model alongside our business development activities. Clearly, when big pharma is willing to pay $1 billion for an asset that has been in a few mice, there's clearly an incentive to do in-house innovation. And so we now have a significant set of technical and clinical capabilities around fundamental R&D and discovery technologies. In the middle of this vision and the engine room of the commercial business today is what we call the Precision Medicine business. This is far more than just an ATM machine that throws off a couple of hundred million of cash each year. It's a strategic validation of the targets we develop our therapeutic drugs for. It is more robust and streamlined clinical trials because we can see where our drug goes, and it's an early opportunity to build deep relationships with the physician stakeholders that underpin the future of the business. Fourth, one can obviously look at sales and a commercial team simply as SG&A. We view it as building a specialty sales organization that very few companies have. Selling nuclear medicine is not selling a vial or a blister pack. It involves selling complex clinical workflows. And as our product portfolio expands, this is a strategic differentiator because it enables us to build depth with key referral physicians and drive preference towards our product. It's also fair to note that in the major markets, this is a significant financial investment that most of our competition, both present and emerging, cannot afford to undertake. Lastly, you can develop all the great ideas you want and convince people to buy them, but if you can't deliver them reliably every single day, you aren't going to succeed. In most industries, vertical integration is probably wasteful and doesn't offer much of a moat. In radiopharmaceuticals, where you are dealing with products that have shelf life of hours to days at most, there's a huge amount of market share ownership dynamic, intellectual property, and customer differentiation in how you deliver. This is why we have invested over $0.5 billion in the last years to better control our destiny and pave the way for high-value therapeutic products. Next slide, please. To do all these things, you need cash, and we have a very high-growth business that made a step change this year, both through organic growth of our Precision Medicine business and through acquisition. We expect all of our revenue streams to continue to diversify and grow in 2026 and beyond, and Darren will cover this off on guidance later in this presentation. Kevin is also going to frame this in terms of the core growth of the Precision Medicine portfolio, which is extremely exciting. The key point is we have a hyper-growth business, and it generates the cash we need to aggressively expand, further diversify our revenue and dominate the field. Slide 7, please. This slide puts the whole strategy into perspective. As I've already said, to deliver on our bold vision for being the dominant player in radiopharma, we need a cash-generative business. We have one, and we grew it significantly this year with revenues exceeding USD 800 million or over AUD 1.2 billion for anyone that prefers their green back surge with shrimp on the barbie. Our margins have remained extremely stable despite competition, and this excellent commercial performance enabled us to invest $0.5 billion into growing our product pipeline, funding the best commercial team in the industry, and building our infrastructure and supply chain. Think about that. $0.5 billion to grow the future value of the company from earnings without shareholder dilution. Telix is a very unique and valuable story. Moving on to Slide 8, please. Before handing over to Darren, I thought it would be useful to give you a condensed view of our priorities for 2026. I get a lot of feedback that Telix is complicated, but it really isn't. This year is about doing three things and hopefully doing them better than we did last year. One, we are going to continue to grow our core business around our approved products. We actually did get a new and innovative product approved by the FDA last year in Gozellix that also leverages the ARTMS isotope production acquisition. The launch of Gozellix has been successful and is not only growing our ASP and market share, it will pave the way for many future products through both the RLS network and partner distributors with Zircaix being the next prime example of this technology platform. Two, we have 2 new products to launch, Pixclara, which is known as Pixlumi in Europe. This is for glioblastoma and Zircaix for renal cancer. We understand the disappointment that these did not get approved last year, but this is the price of being at the forefront of innovation in new technology areas. While people are well aware, it has been a tumultuous period within the FDA itself, we also made certain we took valuable learnings from the experience. We have made extensive changes to the management team. We boosted our regulatory affairs capabilities, and these programs are in good shape for resubmission and approval this year. They are highly anticipated products and will become significant revenue streams, and we have not taken our foot off the gas pedal in terms of market readiness for these products. We are preparing to launch, and I want to make that very clear. Last of all, we have several very high-value clinical programs. This is not an exhaustive list. In fact, we have over 30 sponsored and collaborative studies running from early stage to pivotal trials. But these are the ones that are going to generate the greatest commercial and financial inflection points this year and are the priority in terms of our resources and R&D investment. I note that 4 out of 5 of these studies are pivotal or Phase III studies. We have imminent data point coming out on ProstACT Global, which we will take to the FDA to gain clearance to commence Part 2 in the United States. I remind you that the study has already progressed to randomizing patients ex-U.S. for Part 2 of the study and talk a little bit about this later in the presentation. Our BiPASS biopsy study will complete enrollment this year, and we expect to generate significantly enhanced revenue in 2027 as a consequence of this Phase III study. Our current late-stage clinical studies pave the way to our first therapeutic commercial inflection point likely in 2028. So these are not distant thoughts. They are all near-term catalysts. And I will come back at the end of presentation to some of the broader sets of upcoming catalysts. Now Darren, over to you for the numbers.

Thank you very much, Chris. We have today reported a 56% growth in revenue to $804 million. This is in line with our revenue guidance. Notably it's our third consecutive year of double-digit revenue growth. Revenue from Precision Medicine business year-over-year. Can I just ask, I think that the... [Technical Difficulty]

Please check your mute button.

This year -- sorry, can people hear me now?

Yes, we can hear you.

So this is in line with our uplifted full year guidance. And notably, it's our third consecutive year of delivering double-digit growth -- revenue growth. Revenue from our Precision Medicine business increased 22% year-over-year with EBITDA improving 25% to $216 million, driven by strong demand of Illuccix and the launch of Gozellix. The Precision Medicine commercial performance permitted Telix to self-fund and derisk our investment into our R&D pipeline and commercial infrastructure to drive future growth. Further, 2025 was a year of significant investment, yet we maintained a solid cash balance of $142 million. We achieved this while exercising disciplined cost management. Next slide, please, which is Slide 11. Thank you. We've added this slide for our non-account investors. As at a glance, this slide presents the strength of our business model. The left side of the chart shows our revenue sources and their materiality. The middle of the graph highlights our gross margin in the green and that 94% of the GM is generated from our Precision Medicine business. That is approximately $400 million. As you can see, about half of the gross margin, the red flows om right are invested into our commercial sales and marketing capability, our global supply chain and our corporate functions. But more importantly, flowing right at the top half of the gross margin is approximately $200 million. That's 25% of revenue. And with this, we decide to either invest it in our development pipeline to create future value or recognize it as operating profit. So as business models go, a business that throws off 25% of revenue as operating profit to reinvest in value creation or the bank is pretty damn attractive. Now moving to our traditional P&L. I've spoken to most of the financial highlights on the previous slides, but will take some time to talk to further highlights. The group's gross margin of 53% remained consistent with the first half performance. We invested $157 million into product development, in line with 2025 guidance and mainly focused on our late-stage pipeline. General and administration expenses decreased to 12% of revenue from 17% last year, reflecting the efficiencies of scale achieved as the company continues its strong growth trajectory. As a result, we posted an adjusted EBITDA of $39.5 million, in line with market consensus. Now moving to our next slide. Telix Precision Medicine business is clearly our cash machine. Its financial metrics demonstrate its excellent performance. Precision Medicine delivered an additional $113 million in revenue, representing 22% year-on-year growth alongside a 28% increase in operating profit and a 25% increase in its EBITDA. This demonstrates the high-growth business with capacity to generate significant funds to invest in long-term value creation. Sales and marketing investments supported the launch of Gozellix, the geographic expansion of Illuccix and the launch readiness activities of Pixclara and Zircaix. As a side comment, if this was a stand-alone business growing at 20% plus per annum on an extrinsic value basis, it would be worth up to 8x revenue. This is a huge value creation for shareholders. Now moving to our next slide, in Telix Manufacturing Solutions or TMS. We've provided this level of detail on TMS in our half year results for two reasons. Firstly, to give investors and analysts clear visibility into the financial impact of the RLS acquisition; and secondly, to provide transparency into the cost base of the remaining TMS business, helping with financial modeling. As you can see, RLS delivered positive EBITDA for the first 11 months post-acquisition. At the remaining TMS facility, we increased investment compared to last year to permit us to advance operational activities facilitating clinical and commercial supply. As we now close out the full year of having RLS in the business, we will revert back to reporting TMS as one segment for commercial and competitive reasons. Now moving on to cash flow. As you can see in this cash bridge, Telix continued to generate strong operational cash flows, which we then invest into our pipeline. In 2025, Telix generated $206 million from operations, enabling the investment into progressing the R&D pipeline. Excluding our last contingent consideration earn-out payment of $52 million for Illuccix, we produced a net positive operating cash flow of $35 million. I reiterate that our investment into R&D is discretionary and can be flexed depending on our commercial performance, permitting us to effectively manage our cash position. Additionally, Telix utilized cash on hand to support targeted strategic investments such as RLS, ImaginAb, and in our FAP asset. As a result, we ended the year with a prudent cash position of $142 million. Next slide, please. As we prepare for our next phase of growth, we continue shifting allocation of R&D investment into our therapeutic pipeline. In 2026, R&D investment is planned to be in the range of $200 million to $240 million, with the largest allocation directed to the therapeutic development. This highlights our focus to transition to a high-value therapeutic business. I'd like to take the opportunity to reiterate our investment strategy. Over the next 2 to 3 years, we expect to grow revenues by advancing assets from clinical development to commercialization, expanding indications and geographic reach. We will invest the funds from this commercial growth into our portfolio and ensure that we have the capabilities, infrastructure, and readiness to deliver on our therapeutic programs. Our focus will remain on reinvesting revenues back into the business over the next couple of years rather than optimizing near-term earnings per share. We are committed to building long-term value. We believe prioritizing earnings too early can impede the strategic investments required to fully unlock the potential of our pipeline. Next slide, please. Telix has a disciplined capital allocation approach that is aligned to our corporate strategy, and it has matured a great deal over the last 12 months. We have previously spoken about our 4 areas of focus, and they are investing into our R&D, optimizing our commercial performance, strategic growth opportunities through M&A, and supply chain resilience and production capacity. We believe these 4 areas of focus will underpin our growth long term. We have continued to deliver on our strategy in a disciplined way, ensuring that we have a prudent cash buffer on the balance sheet. Next slide, please. Looking forward, we see strong momentum heading into 2026 with another year of roughly 20-plus percent revenue growth anticipated. Our full year 2026 revenue guidance is set at $950 million to $970 million, and this is based on current approved products in approved jurisdictions. This range does not include revenue contributions from pending product approvals, which will be incremental. This growth implies up to 25% growth in our Precision Medicine business and a full year of RLS revenue. Our corresponding R&D investment will be in the range of $200 million to $240 million and will be dependent on the achievement of certain clinical outcomes and development milestones. In conclusion, we delivered another year of double-digit revenue growth, made high-value strategic investments across the business, and maintained a prudent cash position. Looking ahead, 2026 is set to be an inflection year with numerous important milestones. Our revenue guidance reflects the confidence we have in the business, and we remain committed to disciplined financial management throughout 2026. I'll now hand you over to Kevin Richardson, Precision Medicine CEO. Thank you.

Thank you, Darren. My first slide, please. Last year, our Precision Medicine portfolio delivered $622 million in revenue, up 22% year-over-year. Importantly, we delivered sequential growth every single quarter. That includes Q3, our most challenging quarter, which was the first full quarter following the expiration of Illuccix transitional pass-through status and the transition to MUC, MUC or mean unit cost reimbursement for a subset of Medicare patients. Q3 allowed us to see the full impact of that change on the business. Even in that environment and despite ongoing competitive pressure, we still delivered 3% quarter-over-quarter dose growth and 1% sales growth. That performance speaks to our disciplined approach to business fundamentals and the strength of our customer-facing team. We continue to gain share based on clinical differentiation and operational reliability, our PSMA agents demonstrates fewer indeterminate bone lesions and higher inter-reader agreement compared to F-18 assets, driving confidence in clinical decision-making. We pair that clinical value with highly specialized commercial organization that engages customers every day and consistently differentiates Telix in the market. Our reputation as an innovator also positioned us for a successful launch of Gozellix. Gozellix was FDA approved in April of 2025, and transitional pass-through status became effective in October, enabling a transitional pass-through supported full launch in Q4 of 2025. We are very pleased with the early uptake and our 2026 full year guidance underscores our strong conviction in the growth outlook for our Precision Medicine portfolio. Today, we are the only company with 2 PSMA agents on the market. This dual product strategy is a competitive advantage, offering different types of customers meaningful choice across economics and scheduling flexibility while reinforcing our commitment to meeting diverse clinical and operational needs. In short, resilient growth, clinical differentiation, disciplined execution and a platform built for sustained growth. Next slide, please. What does it take to win in a maturing PSMA market? Winning in a mature PSMA market is no longer about being first. It's about executing at scale. Clinical credibility is nonnegotiable. Products must deliver consistently high image quality, strong inter-reader agreement and reliable detection at low PSA levels across all patient types. Incremental claims aren't enough. Confidence in clinical decision-making is what sustains adoption. Workflow integration matters. In a high-volume market, solutions must fit seamlessly into established clinical pathways, enable same-day imaging and support high patient throughput without disrupting nuclear medicine operations. Reimbursement sophistication is a competitive advantage. Success requires multiple product strategies that give customers economic flexibility while navigating complex and evolving reimbursement frameworks over extended period of times. Commercial infrastructure is a must. This is a contract-driven market that demands experienced field teams, market access expertise, compliance rigor, and long-standing customer relationships. These capabilities take a large investment in years, not quarters to build. Supply chain excellence separates winners from participants. Reliable, flexible dose production and delivery at scale, supported by high service nuclear pharmacy last mile experts is critical. There is no proven shortcut to mass market large volume coverage. Sustained investment fuels durability, indication expansion, life cycle management and camera technology advances all require ongoing clinical and operational investment to maintain leadership. In short, leadership in PSMA is earned through clinical trust, operational reliability, commercial scale and disciplined investment, not novelty. Next slide, please. We continue to execute our strategic plan to grow the Precision Medicine business by expanding our product offering, expand our indications on those products and expand the geographies where we market those products. Global expansion is a priority for Precision Medicine here at Telix. Illuccix is now available in 17 countries with reimbursement secured, and we hold marketing authorizations in more than 24 markets. In 2025, we focus on country-by-country access. In '26, we pivot to driving uptake, particularly across key markets, including the U.K., France, Germany, Italy, and Spain. In China, we delivered strong Phase III results with 94.8% positive predictive value, including patients with very low PSA levels. We submitted the NDA to the regulators with our partner, Grand Pharma. And with prostate cancer incidence rising and PET/CT infrastructure expanding rapidly, China represents a significant growth opportunity. While in Japan, our 105-patient Phase III study is progressing well with the first patient dose. This positions us well in the world's second largest pharmaceutical market where prostate cancer remains a leading cause of mortality. New products and new indications enhance our ability to take share and grow the market and Gozellix is off to a strong start, and we are focused on accelerating commercial momentum in 2026, and you can see that is reflected in our 2026 guidance. BiPASS is a Phase III study that represents the next wave of innovation, combining PSMA imaging, Illuccix or Gozellix with MRI to improve diagnostic accuracy and potentially reduce or eliminate invasive biopsies. This is about moving earlier in the care pathway, reducing patient risk, lowering system costs, and expanding the total addressable market to include frontline biopsy candidates. We believe moving to the front line where patients are diagnosed will give us a competitive advantage, both as the lead PSMA in diagnosis, but also in sequential scans that happen later on in the patient journey as physicians want to see consistency scan to scan. For Zircaix, we've completed 2 Type A meetings with the FDA and believe we have full alignment on key resubmission requirements. We are now focused on completing the agreed deliverables and documentation required for the resubmission. With breakthrough therapy designation, supportive ZIRCON-X data and the inclusion in major international guidelines, this remains a top priority for approval and launch this year. This is a really exciting and highly anticipated product. Moving on to our neuro platform. We are pursuing complementary submissions in both the EU and the U.S. TLX101-Tx was filed with the European regulators recently, and the U.S. submission will follow closely. As a reminder, the FDA has granted both orphan drug and fast track designation for Pixclara. Our commercial, medical, and supply chain teams are launch ready. Our expanded access programs serve patients and our customers very well, and they anticipate commercial use of Pixclara. In short, we built a global commercial platform, delivered successful launches, taken share, penetrated the available market and advanced multiple late-stage assets in high unmet needs markets. We are entering our next phase of growth with momentum and discipline. Next slide, please. So what does this strategy mean in terms of financial impact? Our current baseline business with some further life cycle management, which we've talked about, should be able to sustain a 15% to 20% annualized growth. This partially reflects the growth of the field overall, as well as our ability to continue to capture market share as the size of the market expands. The recent addition of Gozellix certainly derisked this. With indication expansion in prostate cancer alone, particularly a major opportunity in the BiPASS study, this growth over the 5 years can be closer to a 30% CAGR. And then when you add in Pixclara and Zircaix, this growth rate defensively looks more like 40% compounded annual growth, especially with metastatic indication expansions that further drive procedural volume. In short, our current product strategy, which is fully baked from a clinical perspective, just needs to clear a few more regulatory hurdles as it represents future upside for the company. It is a direct consequence of the market presence we are building, the depth of our pipeline and the quality of service we are able to deliver to the patients. This is really an exciting business with a bright future. The growth in Precision Medicine gives us the ability to finance the growth potential of our Therapeutics business. On that note, I'll hand it back over to Chris, to give you a bit of perspective on that.

Thanks very much, Kevin. Great update, and congratulations on all the success that your team had this year. It was a really remarkable year of accomplishment. So moving on to Slide 25, please. In a way, this slide is a simplified version of my opening slide, a highly profitable cash-generative business that would garner, as Darren said, a very healthy revenue multiple. It was a stand-alone business, but it's our engine room. And the future growth trajectory of the business will come from how that cash is invested. Kevin has already shown you very clearly, I think, how the Precision Medicine business alone can grow expansively over the next 5 years based on clinical, regulatory, and commercial inflection points that we expect to achieve this year. So again, I just want to reemphasize the point that the growth trajectory that Kevin has talked about comes from events that will be completed this year. I think it's also important to reinforce our commitment to manufacturing and supply chain. But in the context of our Therapeutics business, it's more than just reliable and on-time dose delivery. It's about R&D cost and efficiency and perhaps most importantly, intellectual property capture. We've learned over the last decade that when we use contract manufacturing organizations, do product scale up, that we simply educate the ecosystem in a way that potentially empowers competition, and we no longer wish to do that. So especially, as our therapeutics go into late-stage trials, this has become an important strategic objective of the company. To be clear, we still use CMOs, but where there's key IP around platforms, targeting agents and certain key isotopes, we are increasingly tackling this in-house or with selected partners. Moving on to the next slide, please. And this slide shows the reason why. As I've said, Kevin has already talked about what share of the Precision Medicine side of the business we think we can tackle over the next 5 years or so. And on a TAM basis, it's actually pretty conservative. But the therapeutics opportunity is about 3x or 4x bigger for the targets and indications that we are already pursuing. This doesn't even capture the potential for indication expansion into new disease areas that some of the pan-cancer targets we are developing, like carbonic anhydrase IX and FAP can potentially expand into. So it's a really bright future for the theranostics strategy. Moving on to Slide 27, please. Over the last 5 years, we've built a very strong pipeline with some key disease focus areas, and you're going to increasingly hear us talk about these disease areas as multiproduct concentration areas, frankly, much as we have done with Gozellix and Illuccix on the Precision Medicine side of the business. Indeed, to tackle some of these major unmet clinical needs, it's going to, in some cases, require a multi-asset approach at different stages in the clinical development or in the clinical patient journey. And so -- and also well-considered combination therapies with standard of care medical oncology. This is evident already, for example, in the design of the ProstACT GLOBAL and IPAX-BrIGHT studies. There are three particular attributes of our pipeline that I'd like to specifically comment on. Firstly, by taking a theranostic approach, we built a very deep relationship with the referral and prescribing physician in each of these disease areas. This is a competitive advantage, and this relationship depth has already started with our existing commercial product portfolio and will only intensify over the next 12 months. Investors often view the Precision Medicine and Therapeutics business areas as adjacent, but they are clearly not. Secondly, while we have some very high potential early-stage programs, and this has not exhausted this list because we have a pretty decent preclinical portfolio coming in behind, we have 3 late-stage programs in prostate, renal, and glioblastoma that will generate significant data over the next 12 months. Based on the current valuation of the company, these programs are essentially a free option, but we think that the data and clinical basis of these programs are very compelling. Most importantly, while 2026 and 2027 financials will reflect the commercial expansion of the Precision Medicine business, 2028 is our commercial launch year for our Therapeutics business. So it's not far away. This is why we have so much execution focus on the [Technical Difficulty] targets, learning about disease extend, exploring new patient populations and ultimately increasing the market size and market share. For the therapeutics, when they become available, the Precision Medicine business will pave the way. And so notwithstanding a few challenging but also educational regulatory speed bumps we've had, our commercial imaging gives us the skills and confidence that we can deliver on the therapeutic programs in the future. We've learned a lot this year, especially last year. Can you hear me, okay? All right. Moving on to the next slide, please. As I noted earlier, we have many different clinical studies running, some company-sponsored, some in collaboration with key opinion leaders around the globe. But the 4 major trials to watch this year are outlined here. I'm not going to go blow by blow on these because this is an earnings call, but I think it's important for shareholders to understand where the research priorities are and what the development goals and catalysts are. We are collecting a ton of patient data this year, and it's very exciting to have 3 programs in pivotal studies. This is important for patients and important for shareholders, and it's taken a lot of work and investment to get here. Moving on to Slide 29. Of course, front of mind for patients and shareholders alike is the ProstACT GLOBAL study. The study is now recruiting into Part 2 randomized part of the study ex-U.S. and is ramping up very nicely. Unlike Part 1, which is a safety dosimetry run-in study that the FDA required in order for us to include U.S. patients in the randomized part of the study, Part 2 is very streamlined and straightforward. Part 2 commenced recruitment last year following an independent data safety review that determined that Part 1 data met prespecified safety criteria to progress. We will be shortly releasing the details of the Part 1 study concurrent with our submission to the FDA to request approval to add U.S. patients into the study. We are looking forward to getting these results out into the market and to show the great progress we are making, particularly given the unique combination therapy design of the ProstACT GLOBAL study. To remind you, the data we will be putting out from Part 1 will be safety data on the 3 standard of care combinations in the global study, as well as comparative dosimetry data, which will be very interesting to see, particularly for the 2 different androgen deprivation therapies used in the study. So this is coming soon. Moving on to Slide 30. Before I wrap up with a summary of the catalysts, I thought I would share a montage of patient case studies to really tie together the company's strategy and to illustrate how integrated the Precision Medicine, Therapeutics, and Manufacturing businesses are. In short, why we are here. This slide illustrates 4 patients in 4 different cancers, all of which are advanced, extremely difficult-to-treat cases. Every day across the entire portfolio, we see examples of where our development and commercial pipeline changes lives. Sometimes it's a better understanding of the extent of disease. Sometimes it's a profound disease modification, such as the metastatic prostate and breast cancer examples on this slide. And at times, it's the glioblastoma or the kidney cancer patient that has stabilized disease or enough reduction in pain to be able to return to work. These are the real outcomes from our research, and they deliver profound and life-changing outcomes for patients. This is what motivates us and why we believe that investing our hard-earned cash into this future is so important. The technology works and will get better as we learn more and get more clinical experience. I'm also obliged to point out that for the most part, what you're seeing here are images created with the companion diagnostic imaging agents that we are also developing and highlights that this -- that not only is imaging technology critical for diagnosing and staging patients, but will play a fundamental role in predicting and measuring disease control as well. Moving to the last slide. To wrap up, this slide summarizes the year ahead. It is a big year with many inflection points across the entire business. I will not go line by line, but we have a lot to talk about in 2026, with the next 3 major catalysts being resubmission of Pixclara and of course, Zircaix and the release of the Part 1 global data. We are looking forward to delivering these important milestones to patients and shareholders as the year progresses. With that, I will pause and hand it over for questions.

[Operator Instructions] Our first question comes from Laura Sutcliffe with Citi.

At the risk of potentially making myself a bit unpopular, I think we'd like to understand a bit more about when we might see some data for 591, the safety data. And perhaps given that you said you will disclose at the same time that you go to the FDA, whether the next steps are things that you need to do at Telix or whether you're waiting for the FDA to do something on their end to be able to get to that point?

Laura, thanks for your question. It's not a bad question or an unpopular question at all. So we have had an independent data safety review board that has under the clinical charter of the study has reviewed the data and progressed to randomization ex-U.S. However, in order for us to send the information to the FDA and disclose the information publicly, we need just to complete the clinical case report forms and formally close out and quality control and validate the data because that's obviously what the FDA wants to see. As soon as we have that data -- and I haven't seen it, I'm not privy to it. But as soon as it's available, we will simultaneously disclose it and submit it to the FDA. So we're not waiting on anything from the FDA. It's all on the company side, and you will not have long to wait.

Our next question comes from Tara Bancroft with TD Cowen.

This is Nick on for Tara. Congrats on the progress and the strong guidance for 2026. We were hoping that you can dive in a little more on what you've seen in the early innings of the 2-product strategy for Illuccix and Gozellix and how you anticipate that will evolve this year to reach the 25% growth in the precision medicine revenue?

Yes. Thanks very much for the question. Kevin, do you want to pick this one up for your wheelhouse?

Sure. Yes. Thank you for the question. So the 2-product strategy is -- enables us to really manage the economic needs of HOPPS accounts and the way that they perceive and their preference for a reimbursed product over really a non-reimbursed product. As you know, MUC or Main Unit Cost has really kind of changed the environment and the reimbursement environment there as well as the way that the pricing happens in the HOPPS accounts. So being able to have a 2-product company enables us to manage that particular customer type and the self-standing -- or we call them IDTF group -- in a different way as we manage the preference they have for a reimbursement price or one that might be a little more price sensitive. So and then, of course, we have a longer view of the precision medicine business and PSMA specifically, as we think through what over time can happen and what will happen with CMS as they continue to evolve and change reimbursement. So that enables us to kind of manage the ASP, if you will, as the CMS may or look more towards the ASP reimbursement model. So it gives us options in the future without locking down a singular product on that.

Our next question comes from Shane Storey with Canaccord Genuity.

Kevin, I'm going to stick with you, if that's okay. Question on Pixclara. Just maybe some descriptive piece, I guess, around the customer channel there. It's quite different from your PSMA urology presence. Is that potentially a first work example for how the Varian relationship might evolve? Just some thoughts on that, please.

Kevin, are you there?

Yes. So I'll take that first then, Chris. So Varian is -- we're really excited about the possibilities in that, a lot focused, of course, on PSMA and Illuccix, Gozellix. And so as we think about that from a commercial perspective, we have a -- what we call a Ninja team. As you know, there's not as many sites as there are that do PSMA prostate scanning as there are that are going to do neuro scanning. So we have a smaller team that's focused on the referral, the neurologist. And the idea behind that is we already have the relationship at the NucMed level. So we're able to drive those patients into the scanner, if you will. And then we have a team that already has the relationships at the other end of that where they're reading it. So the idea is it's a referral and then into the existing relationship we have at the nuclear medicine side. And of course, if that is not an Illuccix or Gozellix site, it gives us good access into those sites, and it's a real competitive advantage to be able to offer these more orphan drug type technologies because of that. Does that answer your question, Shane? Okay. Chris, anything to add?

All right. No, that's good.

Our next question comes from David Stanton with Jefferies.

I might be following a dead horse here, but I just want to make it clear and help you to make it clear. You'll be reinvesting earnings to get close to 0 NPAT for F '26, F '27 and F '28. Is that what the market should be thinking going forward, please? I ask because it's a question I get asked the most.

Yes, that's fine. No horse is flogged, David. Happy you asked the question. So we're not giving guidance beyond 2026, but it's a reasonable expectation that in 2026 and 2027 that we will be investing -- other than for risk management and for appropriate balance sheet management purposes, we'll be investing the majority of our earnings back into the company, okay? So that's in a number of different areas. That's in R&D. That's also in growing and developing our commercial team. And of course, we continue to also invest in infrastructure and capital works to support the business. So it's not all just R&D, but a profit objective for this year and next year is not the name of the game.

Our next question comes from David...

Do you have a further comment, David, that you'd like to ask? All right. Well, we'll move on. This is a very challenging conferencing service, and I apologize to those that are participating.

It's a follow-on from Dr. Stanton's question. Just from Darren, there was a clear comment there that I think that the investment in growth will consider the commercial performance. I think that was interesting from our perspective. Just as we look at the sales guidance for '26 and the R&D guidance for '26, should we think that if the commercial performance is at the upper and lower end of those ranges, the R&D will follow? As an extension of that, within the R&D spend, is the earlier stage clinical trials, are they the ones that would potentially be put on hold for a little bit to the extent that the commercial performance doesn't meet expectations?

I can start, Darren, and then maybe if you want to add anything. I mean -- so yes, we've focused -- we've chosen in this presentation to highlight the clinical studies that are the real priorities for the company. So that's the 5 studies, including the BiPASS study. We are obviously going to be investing in other clinical studies this year. And to the extent that we need to make adjustments -- it will be outside of that sort of ring-fenced 5 studies, the 4 therapeutic studies and the BiPASS study. We clearly expect that 2026 is going to be a strong year. We don't expect to have any difficulties in financing our R&D pipeline. But as you have noted, and as Darren, I think, made it very clear, generally, we take the view that our R&D investment is discretionary, and we can make adjustments as required. Darren, do you want to add anything? Okay. I'll take that as a no.

Our next question comes from Craig Wong-Pan with RBC.

Just a question on the 25% growth in Precision Medicine. I was wondering how much growth was coming from markets outside of the U.S.

Sure. I'll answer that one and then maybe, Darren, if you want to chime in on anything that I've missed. Right now, because we only achieved our European reimbursements towards the back end of last year, it's a very small proportion of the revenue is currently ex-U.S. The majority of it is -- 95% of it is U.S.-based. We obviously expect that mix to change over the course of this year and also as we add in other markets, such as Japan, which has a high-value PET -- advanced PET procedure code that's quite internationally competitive. But for the moment, for the most part, the majority of our revenue is U.S.-based.

Our next question is coming from Andy Hsieh with William Blair.

Chris, I want to ask you about the recent collaboration with Atley and Stanford, focusing on astatine-211. So in your pipeline, you have 3 alpha emitters: Actinium-225, you have lead generator that's in progress, and then now astatine having a California supply chain. So I'm curious about your view on this isotope, another short half-life. Just wondering about how it fits into your product portfolio.

Yes. It's a bit of sort of outside of the major sort of activity area. But essentially, we do see value in alpha emitters. The majority of our late-stage programs, as you know, are beta-emitting isotopes. We think that they're going to be a workhorse for the foreseeable future, but we can see ALPHIX coming over the horizon. As you know, most of our clinical stage programs are with actinium. It's probably from a supply chain perspective, the lowest hanging fruit. We have one program, TLX102, which is with astatine that's in early clinical translation. We think that for applications where a targeting agent needs to cross the blood-brain barrier that radiohalogens are a better perhaps a more practical pathway than a radio metal with a chelator. So we are exploring astatine mostly in the CNS setting. Then we do, as you know, have a lead generator that we've developed. It's a very novel and very compelling generator design that we think can be rolled out for large-scale lead production. We currently today do not have any clinical programs using Lead-212, but we have a number of preclinical programs that we expect to take into patients by the end of this year that are not currently disclosed, and they have the potential to use Lead-212. We are exploring several different isotopes. But I think as a company, we've elected to put a proportion -- not a large proportion, but a modest proportion of our R&D expenditure into understanding the future landscape of alpha because we think it has some potential. I hope that answers your question.

Our next question comes from David Dai with UBS.

Just on the gross margin for the business, it seems like it's remaining stable at 53%. But then the RLS business, the gross margin has been quite poor. So just thinking about the gross margin for RLS business moving forward, what are some of the key drivers of gross margin expansion for the RLS business that you can provide?

Well, I'll just make a comment, and then I'll invite Darren to chime in. So the RLS business -- so just to be clear, when we report the RLS segment, we report the RLS segment purely in terms of third-party products. So these are not Telix products. These are, for the most part, fairly generic nuclear medicine products. And RLS' operating cost is largely covered by delivering those third-party products. So a useful way to think about it is as a subsidized -- third-party subsidized manufacturing infrastructure. When we report the products that go through the RLS network that are Telix products, they are captured in the segmental reporting for precision medicine. So I just really want to make that very clear. So when you say the gross margins for RLS are not very good, it's got nothing to do with Telix's product portfolio. RLS margins -- because these are generic sort of fairly commoditized nuclear medicine products, they have a much, much lower margin. We provided an average margin last year, which I think frees a lot of people out because all of a sudden, we went from mid-60s margins down to mid-50s margins or low 50s margins. That was an average effect across all of the products in the group, including the RLS products. Does that make sense?

Yes, that makes sense. Yes.

So yes, so don't be sidetracked by RLS. The most important thing is that when we put our products through RLS, we -- that gross margin number, which we report faithfully for the Precision Medicine business as sort of mid-60%. That's our -- that above-the-line cost is our distributor margin, which clearly is different when we run a product through our own pharmacy network. Now it's critically important for us to maintain key distribution partnerships in key markets. So we obviously, do pay that above-the-line cost. But when we produce a product that goes through our nuclear pharmacy network, the gross margin is rather different. So you should expect to see, as we have a larger share of our product volume going through our in-house pharmacy network that, that gross margin number has the potential to improve and trend towards 70%.

Our next question comes from Andrew Paine with CLSA.

Maybe one for Kevin, but you mentioned winning in the PSMA is about executing at scale, and we've seen that in the growth and the challenges you've overcome in that market so far. You spent a bit of time talking about this, but how clear is it that moat -- how clear is that moat there for you given the potential competition on the horizon? And also, can you just dig into the changes in camera technology and how you see that as supportive to the sensitivity of PSMA imaging, which may not be fully appreciated?

Well, I think Kevin has done a great job of running through what the competitive barriers to entry, and there are multiple. I mean it's not just product, it's also clinical, it's also manufacturing and supply chain. So I'm not sure what competitor you're talking about that's coming immediately on the horizon. But nonetheless, we see those as, I mean, pretty well enumerated sort of barriers to entry for competition. On the topic of camera technology, generally speaking, we've seen a step change in sensitivity on PET cameras over the last 3 to 5 years because of the demand for PET imaging, not just in prostate cancer, but across a whole lot of indications, including neuro-oncology, neurodegeneration, cardiovascular disease. We're seeing a lot of camera installation going in and the next generation of scanners are in order of magnitude more sensitive. And so that just means that we have to keep abreast of it. We need to make sure that we're running clinical trials and clinical studies that demonstrate the improved utility. We are clearly detecting disease early and earlier. I mean, we have our most recent studies that were done in China, for example, with absolutely state-of-the-art scanners because they're brand-new scanners. We're seeing PSA levels down to fractions of a nanogram per ml. And so the camera technology is part of the complementary story to Tracer development that should not be forgotten about. I think I'll pause there in terms of that particular topic. There isn't too much more else to say. Is there another question?

Our next question comes from Melissa Benson with Barrenjoey.

So Kevin mentioned you had a full alignment on the agreed deliverables with the FDA for the...

Melissa, I'm sorry, I can't hear you. Now I can hear you. Go on.

I'm sorry. So I think Kevin was mentioning there was alignment on the agreed deliverables with FDA, [ per the K ]. So I was just wondering if there's anything you can share regarding what those agreed deliverables are, but specifically, if there's any new clinical data required or if it's more preclinical analytical data only?

Yes. Most of the CMC remediation topics are around laboratory documentation, manufacturing documentation and process documentation. We do have a deliverable to the FDA around comparability between the research grade material that we used in the Phase III trial and the commercial scale-up material. But we have that data set well in hand, and it's not a material time delay to the resubmission.

Our next question comes from Steve Wheen with Jarden.

It's Steve here. So my question was just a bit of an extension of some of the others. But I guess for Kevin, I'm just trying to understand the European market with regards to Illuccix and Gozellix, I guess. Just they've been approved for some time. The launch in the U.S., obviously was incredibly rapid. And just trying to understand what's holding it back or slowing it to not really be much of a feature for your growth in the next 12 months?

Kevin, I can start and then maybe you can finish. I mean, it's not that it's not a feature. It's just that the European market has a very different reimbursement landscape. The U.S. has a much more immediacy between product approval and reimbursement, whereas in Europe, sometimes there can be as long as 9 or 12 months delay between product approval and reimbursement. And there's simply no material product sales until you have reimbursement. It's also not a class reimbursement. It's an individual product reimbursement in most countries. So until you have reimbursement, you simply don't have material sales. So for the -- what you would classify as the traditional EU 5 countries, we have only just received reimbursement in some of them. Kevin, I don't know if you want to add anything there?

Yes, there's very little other color to add in my prepared remarks, which was really 2025, the international team under that direction was really focused on gaining market access through reimbursement. And now we in that EU 5, the plans now are to execute those market launches. And so you'll see that as we continue to grow in 2026 as we execute against that launch. But Chris is right, in each country is different, each product is different. So it takes a bit to get that approved in the system and then begin the launch. So we're in the midst of that right now.

Can I just ask an unrelated question just with regards to your R&D the expensing of Zircaix through the R&D line, is there a shelf life for that particular inventory just with regards to just noticed your comment that there is the potential once it's approved by the FDA that, that could then come back and be backed out of the P&L?

Yes, that's right. That's our expectation. And the shelf life goes far beyond the launch time of the product.

Our next question is a follow-up from Shane Storey with Canaccord Genuity.

Sorry for extending the time, everyone. My question was going to come off the back of Melissa's question actually on Zircaix and except everything you've just said there. But just as far as how we should think about FDA's review phase once the resubmitted BLA is accepted, we've been sort of assuming 6 months. I just unsure how the breakthrough status and priority review might influence that, if at all?

Yes. We don't know yet for Zircaix. For Pixclara, we have a reasonable idea that it's going to be a rapid review also because it's a single a single issue CRL. We could imagine for the Zircaix review because there is a number of issues that it may take longer, but we haven't received guidance yet from the FDA on this topic. We will be engaging with the agency shortly on this topic as we are preparing to resubmit, but we won't know that information for a little bit when it comes to Zircaix. No worries. But I do note that it has a breakthrough designation. And I actually want to compliment the agency. They've been highly engaged, very helpful, very proactive. They gave us a lot of extra time around the Type A meeting that they really didn't need to do. So we feel like it's a pretty good collaboration, and we're working with the agency towards the drug approval and nothing less than that. Okay. I think I have a feeling that we're wrapping it up there. I don't know if there's any more questions coming through.

We do have a final question, a follow-up from David Stanton with Jefferies.

Saving the best for last. Chris, just I note that you've talked to a Part 2 interim analysis in calendar '26. I wonder if you could sort of give us any kind of timeline as to when that might be? Is it third quarter? Is it fourth quarter? What should we be thinking there?

Yes. Obviously, I get increasingly reluctant to estimate timelines on clinical trials because [Technical Difficulty] by like to the day or to the week rather than to the quarter. But right now, the Part 2 study is recruiting really nicely. We're seeing good site expansion and getting plenty of patients consented into the study. That interim analysis is based on about 80 or 90 events, I don't know the exact number, sometime -- somewhere around that. And we would expect that, that should lead based on the current recruitment trajectory for some time in Q4 of this year for that futility analysis to read out. So that's the reason why we have it sitting there in the calendar for this year. Well, I think that was the last question. I just want to apologize profusely to all the attendees for the audio challenges we've had today. It's a new conference provider. I'm not sure we'll be using it again in the future. But I just wanted to thank you for your questions and for your attention. Obviously, if there are follow-up questions, we'll be happy to receive them directly and follow up in due course. Thank you for your time today.

This concludes today's conference call. Thank you for participating. You may now disconnect.

Thank you for standing by, and welcome to the Telix Half Quarter 2025 Results and Investor Webcast. [Operator Instructions] I would now like to hand the conference over to Ms. Kyahn Williamson. Please go ahead.

Thank you and everybody, for joining us this morning and this evening for those joining from overseas. My name is Kyahn Williamson. I'm the SVP of Investor Relations and Corporate Communications at Telix. You can see there our disclaimer. Just moving forward to Slide 4. I'd like to introduce today's speakers that are on the line with me. We have Chris Behrenbruch, our Group CEO and Managing Director; Darren Smith, our Group Chief Financial Officer; Kevin Richardson, CEO of Telix Precision Medicine; and Richard Valeix, CEO of Telix Therapeutics. Today, we'll be taking you through the H1 2025 financial results presentation lodged earlier today on the ASX and our operational achievements for the half. This call is scheduled to run for 1 hour. And following the presentation, we'll take questions firstly from analysts on the phone and request that you ask one question at a time and hop back in the queue if you have further questions. If we do not get to your questions on the webcast, we will reply to you directly. Moving on to Slide 5, please. In today's presentation, our business leaders will be talking to the investments we have made in the business to set it up for long-term value creation. This slide illustrates the scale of our business today, spanning development, commercialization and global production and manufacturing. It's been a rapid transformation. This time last year, we had one approved product, Illuccix, which was commercial in just a handful of companies. Today, we have multiple approved products. We are preparing to roll out Illuccix across Europe and are preparing for launch of Zircaix and Pixclara. The acquisitions we have made have seen our manufacturing and distribution sites grow to 38 and our workforce has more than doubled with now over 1,000 employees globally. Next slide, please. We've previously presented our growth strategy that is in place to drive value creation for the long term. You can see the 4 pillars on the left-hand side of the slide and the achievements we have delivered against each one this half. These pillars are to grow our precision medicine or commercial stage imaging business and the achievements this half are focused on the goal to grow our share in the PSMA market and bring new products to patients. Kevin will discuss this further. Delivering on our late-stage therapeutics pipeline and building our next-generation pipeline, including alpha therapy candidates. This half, we have made solid progress across an array of programs, which Richard will take you through in more detail. And finally, the expansion of our global delivery infrastructure, a key highlight this half has been the integration of the RLS business. Chris will take you through this and the key value drivers aligned to our strategy. Firstly, however, Darren will talk you through the financial results for H1 2025 in more detail. So I'll hand over to you, Darren.

Thanks, Kyahn, and welcome, everyone. From a financial perspective, the first half of 2025 was characterized by strong commercial growth in our Precision Medicine business and continued investment into building our business for the future. We delivered strong revenue growth in the first half of 2025 with group revenues improving 63% year-on-year and driven by growth in Illuccix and the addition of third-party revenue from RLS. Our precision medicine revenues were up 30% year-on-year with EBITDA improving 24%. Gross margins in our Precision Medicine business remained stable at 64%, reflecting efficient manufacturing of Illuccix. The group's gross margin was 53%, reflecting the addition of RLS third-party product mix and the associated manufacturing and distribution costs. In this half, we have made a significant investment into our global manufacturing infrastructure to ensure that we are well positioned for long-term growth and we continue to invest in our R&D pipeline with investment up 47% year-on-year. Following these investments, we generated $18 million in operational cash flow and finished the half year with a healthy $207 million cash on hand. Now moving to the next slide and our group revenues. Telix generated revenues of $390 million. This consisted of $79 million in revenues from RLS third-party sales and $311 million mainly from our Precision Medicine business. This represents an increase of 63% year-on-year and 41% compared to the second half of 2024. Illuccix continues to deliver strong growth, especially as it relates to volume doses. Kevin will provide more detail later in the presentation. Now moving on to the next slide on the group P&L. As stated previously, the group P&L represents a period of solid growth and strategic investment into preparation for delivering future long-term growth. Group gross margin landed at 53% following the addition of RLS third-party products and RLS associated manufacturing and distribution expenditure. R&D increased 47% to $82 million. As planned, we increased our investment into our therapeutic pipeline to be 54% of our overall investment in R&D from 43% last year. Richard will talk to our therapeutic portfolio later in the presentation. Selling and marketing expenses increased to 13% of revenue from 10% last year as we prepared for the product and geographic expansion of our Precision Medicine business and the addition of $7 million in selling and marketing expenses from RLS. Manufacturing and distribution expenditure, excluding RLS COGS increased to 5% of revenue from 4% last year, driven by investment in our manufacturing and distribution infrastructure in ARTMS, Iso Therapeutics and multiple TMS facilities. General and administration expenses decreased to 12% of revenue from 16% of revenues last year. As a result, adjusted EBITDA declined to $21 million, driven by our investments. Now moving on to the next slide. This slide represents the income statement of our Precision Medicine business. As you can see, gross margin is steady at 64%. This indicates that we have maintained our operational efficiency of Illuccix, enhancing our ability to reinvest in growth. As planned, we prepared for new product launches and geographic expansion, increasing selling and marketing expenses to 12% of revenue, facilitating the build-out of our commercial infrastructure ahead of the expected revenue growth. This increase was offset by reductions in percentage of revenue spend on R&D and general and administration. As a result, the precision medicine EBITDA improved $20 million year-on-year, driven by 29% revenue growth. Moving to the next slide of our TMS business. Moving on to the next slide. As we have made significant investments into TMS, I thought it was important to provide details, in particular, the contribution of RLS, which we are reporting for the first time. RLS is the largest component of the TMS business, employing over 500 people across more than 30 locations, integrating last-mile delivery capabilities for Telix. In the next 5 months -- sorry, in the 5 months since acquisition, RLS EBITDA was close to breakeven. The addition of further volumes of Telix's products through RLS will improve the contribution. RLS currently processes 1/3 of Telix's group revenue with total network revenues for the 5 months being $110 million. This includes $79 million of third-party products and $31 million of intersegment revenues related to Illuccix. Gross margins for RLS were 7%, which is typical for this type of business and includes manufacturing and distribution costs from the radiopharmacies. RLS operating expenditure, excluding COGS for the 5 months since acquisition totaled $15 million. We expect these costs for the second half of 2025 to remain at a similar percentage of revenue. Our TMS business also includes various subsidiaries such as Iso Therapeutics, ARTMS and TMS Brussels, Melbourne, Oklahoma, Sacramento, where we increased our investment to advance operational activities at each of these sites. Chris will expand on the TMS strategy later in the presentation. Now moving on to the group's cash flow. In the first half of 2025, Telix has again achieved a positive operating cash flow totaling $18 million, demonstrating the ability of the commercial business to fund the development of our R&D pipeline and funding preparations for market and product expansion. As previously mentioned, Telix utilized cash on hand to make a number of strategic acquisitions. The largest of this was RLS. Cash on hand at the end of June was a healthy $207 million. Now moving on to the next slide. I'd like to take a moment to go over our capital allocation priorities. Telix is focused on 4 areas: firstly, R&D development; secondly, optimizing our commercial performance; third, strategic growth opportunities through M&A; and fourth, supply chain resilience and production capacity. We believe these 4 areas of focus will enable us to deliver long-term growth. Within R&D, we are advancing several late-stage clinical programs and we are optimizing our commercial infrastructure to advance our commercial assets and expand into new areas of focus and geography. In terms of M&A, we invested in 3 strategic assets in the first half of 2025. They were RLS Radiopharmacies, ImaginAb and a FAP candidate. We continue to invest strategically into our manufacturing and supply chain infrastructure to preserve our competitive edge and to ensure we are in a position to scale efficiently as demand grows. We do all of this in a disciplined way by ensuring that we have a prudent cash buffer on our balance sheet. Now moving to my final slide. As stated on this slide, we are reaffirming our full year revenue and R&D guidance. We expect our revenue from Illuccix and RLS to be in the range of $770 million to $800 million. Our R&D investments, we expect to fall in the range of 20% to 25% increase on last year. Finally, I'd like to take the opportunity to reiterate our investment strategy. For the next 3 years, we will grow revenues by advancing assets from clinical development to commercialization, expanding indications and geographic expansion. We will reinvest the earnings into our portfolio and ensure that we have the capabilities, infrastructure and readiness to deliver on our therapeutic programs. At this stage of our development, our priority is building long-term asset value rather than optimizing near-term EPS growth. We believe that focus on earnings too early can be troughed from the strategic investments needed to unlock the full potential of our pipeline. I'll now hand you over to Chris Behrenbruch, Managing Director and Group CEO. Thank you.

Thanks very much, Darren, and good day to everybody online. So I'd like to start by taking a moment, if you could advance on to the next slide, please, to talk about why Telix is highly differentiated and built for long-term success. Starting with our therapeutics pipeline. Our pipeline is built around areas of high unmet medical need with a diversified portfolio strategy that gives us multiple shots on goal, even in some cases, concentrated in the same disease area. Our R&D efforts remain sharply focused on advancing next-generation assets, whether that's in the alpha or beta therapies, novel isotopes or innovative targeting agents. As a data-driven organization, our decisions are grounded in rigorous scientific and clinical evidence, ensuring that we prioritize our limited resources towards the most promising opportunities. Turning to manufacturing and supply chain excellence. I want to emphasize that radiopharmaceutical manufacturing and distribution is an extremely complex business from an operational quality and regulatory perspective. A robust, reliable supply chain is critical to long-term success, especially for a multiproduct portfolio like ours that's also going to one day deliver therapeutic outcomes. This is why we've made strategic investments in selective aspects of vertical integration over the past couple of years, alongside deepening relationships with key strategic partners that we think are best aligned with our long-term commercial strategy. Our investment in commercial infrastructure is starting to deliver real operational and financial returns, including with continued volume growth for Illuccix in a maturing market landscape. This performance reflects our proven track record in commercial execution and I think it positions us very well for future product launches. This year also marks a major inflection point for Telix as we transition from effectively a single product, single market company to a multiproduct, multi-region commercial organization. And we've done it pretty cost effectively. With this global infrastructure in place, our precision medicine assets are laying the operational and financial foundation for the rollout of our future therapeutic pipeline, which, as a reminder, is really not that far away. Next slide, please. So within prostate cancer, our multiproduct strategy supported by next-generation follow-on assets is designed to drive sustained revenue growth. This approach strengthens our market position while expanding our commercial runway. We may have been second to market with Illuccix, but we are leading our new strategy through a life cycle management initiative that will enable us to continue to capture market share and to compete on the merits of our product portfolio to dramatically reduce the impact and viability of new entrants. We'll continue to expand the market -- we'll continue to expand the market through new indications and indication expansion, notably our BiPASS study, a groundbreaking Phase III study that's aimed at expanding the label to use Illuccix and Gozellix right to the front of the patient journey with the potential to disrupt current diagnostic pathways and significantly expand the total addressable market. Kevin is going to talk more about this exciting near-term opportunity during his part of the presentation. Finally, we continue to focus on product innovation, leveraging the strength of our distribution model, customer service and innovation focus to maximize product choice to the benefit of physicians and patients. For example, we recently unveiled the AlFluor chemistry program. This first application -- the first application is the development of a PSMA targeting agent that enables us to combine the imaging benefits of fluorine-18 with the convenience of gallium kit-based workflows the market has already come to appreciate. We have an extensive clinical data package to support this, including a Phase III study in a significant number of patients. Following a helpful consultation with the FDA, we are now planning a registration-enabling study to take this forward to a new drug application. Next slide, please. Let's take a moment to understand what transitioning from a single product, single market company to a multiproduct, multi-region commercial organization actually means. It takes a highly complex global manufacturing and distribution infrastructure to deliver our precision medicine assets and obviously, future therapeutics that are coming down the pathway to patients. Due to the relatively short half-lives of isotopes and the need for just-in-time manufacturing, highly specialized facilities and logistics are required to avoid factors throughout the journey that can lead to disruption and delays. We have continued investing in our manufacturing infrastructure globally to have greater control throughout the process and significantly reduce quality and delivery risk. We see this as a crucial point of competitive advantage because without reliability, there is no commercial traction in this industry. Our global footprint -- global footprint reflects our commitment to leadership in radiopharma. We believe a truly global presence is critical to becoming and maintaining market leadership in this space. Next slide, please. On the topic of RLS integration, the RLS acquisition was a highly strategic investment, enhancing our U.S. presence, which is a critical market with a production and distribution network that covers over 85% of the U.S. and provides last-mile delivery and a footprint to expand our manufacturing capability in the U.S. Darren has already talked to the financial contribution of RLS. I want to touch on the value drivers and integration progress to date. In just 5 short months, the integration is going very well, and I have been personally extensively involved in the process alongside Darren Patti, Telix's Group COO. RLS can deliver value in the following ways. Firstly, we are already seeing the synergies of having 2 distinct commercial teams that complement each other in terms of the way that they view and engage with the market. Having a nuclear pharmacy network provides a new entry point and insights, bringing us closer to the customer and enabling us to identify significant new opportunities. To be clear, our team manages everything from producing the end dose, quality controlling it to walking it into the clinical site. This business is all about service to the end customer. Second is a pathway to margin improvement. The volume of Illuccix sales through the RLS network has increased by 50% on a dose volume basis in the first 6 months since the acquisition. This is not at the expense of our key partners, rather it demonstrates the synergies between the 2 commercial organizations and our ability to capture commercial white space and optimize our competitiveness. PET agents like Illuccix and Gozellix reflect higher-margin, higher-value products for nuclear pharmacies to distribute. As we increase product distribution of our own products through RLS, we expect to see long-term improvement in gross margins and the ability to mitigate competitive and distributor risk. Finally, our goal with RLS is to build a radio metal production network to meet future demand for imaging and therapeutic radiopharmaceuticals to grow the RLS business, but also to reduce our own reliance on third parties for supply chain in the U.S. Again, with this investment, we will be focusing on high-margin products, not historical commoditized products. We are currently in facilities planning and development for 6 cyclotrons across the RLS network initially with the facilities upgrade process to commence in the second half and will be complemented by in-house capabilities to produce select therapeutic products alongside our pharmacy production function for dose drawing and dispensing. So this will support both commercial activity and clinical activity. Next slide, please. So the third part -- third pillar of value creation that I want to touch on is our therapeutics pipeline and platform. We are deeply committed to bringing our therapeutics to the market and this ambition remains a central focus of our investment strategy. As you heard from Darren, it's a growing proportion of our R&D expenditure. We are making meaningful progress across the entire pipeline and the momentum we're building reflects the strength of our execution. I'm going to let Richard speak more about our progress generally across the pipeline. With the acquisition of Los Angeles-based ImaginAb, we acquired a biologics and drug development platform that's really well optimized for targeted alpha therapies. This is an incredibly talented team of people with a huge amount of experience backed by key opinion leaders that have a great vision for what the future targeting platform will look like in radiopharma. The acquired platform uses small engineered biologics or antibodies that enable highly specific cancer targeting combined with fast tumor uptake and blood clearance. With our capabilities in antibody engineering, linker and chelator optimization and isotope selection, we're really well positioned to develop highly potent and targeted radiopharmaceuticals that range from small molecules all the way to advanced biotherapeutic products. We believe these specialist in-house R&D capabilities are fundamental for long-term success of the company. So the next slide, please. So just to wrap up in terms of expectations around top line and bottom line growth and reiterating some of the messages that Darren has given you, I've been showing this chart in our investor presentation since the start of the year and there are some important signaling aspects to this graphic. We are now in the middle stage of our trajectory where we're diversifying our revenue streams, expanding globally and derisking the business. If you recall, our midterm strategy has been to reinvest our revenues into the business to fuel long-term growth. We're making very targeted investments today to position the company for long-term growth, both in top line expansion and bottom line performance. But right now, it's without putting every last dollar into that growth and infrastructure that when we hit our pre- commercial launch year for the Therapeutics business, we are really ready to go. I want to give a little final comment before I hand over to Kevin and take a moment to address the information request from the SEC. I know many people have had questions about it. I'm personally disappointed to be in the situation as I really don't believe it reflects the quality of our organization or our commitment to excellence. The subpoena was a request for documents primarily relating to our disclosure activity related to the development of our prostate cancer therapeutic candidates. We are in the process of responding to the SEC to resolve this as soon as possible. I want to make clear that there have been no allegations or charges leveled at the company or any individuals. We do not know what or who triggered this. Let me be clear, this has no impact on our commercial portfolio or the momentum of our pipeline development. In fact, we're operating with more urgency and focus than ever before to bring these breakthrough assets to patients. I believe you can see evidence of this progress in today's presentation. So with that, I'd like to transition over to Kevin, our CEO of Precision Medicine for a commercial update. Thanks, Kevin.

Sure. Thank you, Chris. And for my first slide, I would like to start with our precision medicine growth strategy. Our growth strategy is based on 3 pillars: expand product offerings, expand geographies and then expand indications on those products. In terms of our first pillar, expanding our product offerings, we have now launched Gozellix, further strengthening our position in the PSMA space. And looking ahead, we have 2 near-term regulatory milestones with Zircaix and Pixclara. These assets will build on our strong commercial foundation established by Illuccix. Moving on to our second pillar. The global rollout of Illuccix continues to progress well with marketing authorizations now secured in over 23 countries. Turning to our third strategic pillar. We are actively exploring new indications for our existing assets, particularly indications where we believe we can deliver meaningful impact for patients. We remain laser-focused on the execution of these 3 strategic pillars, driving the expansion of our global Precision Medicine business and paving the road for our Therapeutics business. Next slide, please. Illuccix continues to deliver strong growth in the high single digits. In the second quarter, Illuccix revenues were up 2% quarter-over-quarter or 25% year-over-year with dose volumes up 7%. Q2 represents the highest unit volume growth we've seen in the last 5 quarters. And despite competitive pricing pressures, we continue to manage the impact to our average selling price. To do so, we continue to drive share growth in clinical accuracy and reliability of dose delivery. Our clinical message is Telix PSMA gallium agents have fewer indeterminate bone lesions and higher inter-reader agreement than F-18 assets. We couple the clinical message with a highly specialized sales force and customer-facing teams that differentiate Telix with our customers every day. We've developed a reputation in the marketplace as an innovator, paving the way for successful launch of our follow-on products. Next slide, please. Moving on to geographic expansion and the global rollout of Illuccix. As you can see, we've established a strong commercial footprint across key markets, including the U.S., Canada, Australia, Brazil, the U.K. and Europe with marketing authorizations now secured in 23 countries. In the second quarter, we successfully launched Illuccix in the U.K. and see encouraging uptake. In the next wave of launches, we are focused on key markets like France, Germany, Italy and Spain. And as you move further east, we're focused on China and Japan, where in China, we have completed our registration study and are preparing an NDA for Illuccix. While in Japan, we are just initiating our Phase III study for Illuccix, and we are happy with the progress thus far. Now on to Latin America, where we have the first approved product for PSMA PET and we have commenced commercial operations there with our partner on the ground. Overall, we remain on track with the global rollout of Illuccix, supported by strong execution in the U.S. Next slide, please. We launched Gozellix earlier this year and successfully delivered our first commercial doses in June. The launch is progressing well through our comprehensive network of distribution partners, Cardinal Health, Pharmalogic, Jubilant and RLS. Telix is the first company to bring 2 PSMA-targeted agents to the market, a differentiated strategy that we believe is central to our competitive advantage. This dual product approach gives customers meaningful choice, whether in terms of economic value or scheduling flexibility and it reinforces our commitment to meeting diverse clinical and operational needs. Now from a reimbursement point of view, we are pleased with the recent HCPCS code we received from CMS, a major reimbursement milestone and look forward to getting an update on the decision around transitional pass-through status in the near future. The HCPCS code will be effective October 1, 2025, streamlining the billing and reimbursement in the hospital outpatient setting for Medicare-eligible patients. Next slide, please. Moving on to our third pillar of growth strategy, label expansion. I wanted to talk about a study that we think has the potential to become the future of prostate cancer diagnosis, our BiPASS biopsy study or biopsy of the prostate avoidance stratification study. Biopsy are highly invasive and carry risk and there are more than 1 million patients getting a biopsy every year with up to 75% of them being negative. When you think about it, what it takes to really be disruptive in this space and be innovative, we think it's minimizing patient trauma, reducing risk and recovery time and lowering cost while improving patient outcomes. Next slide, please. BiPASS is the first registrational study combining MRI and PSMA PET in diagnosing prostate cancer. Patients are categorized into high, medium and low-risk categories for prostate cancer. And for high-risk category, an image-guided biopsy would be recommended. For the intermediate or an indeterminate category, a precision biopsy would be recommended since PSMA is much more sensitive in the detection of prostate cancer and we can perform one and done. For the low-risk category, if there is no uptake of PSMA in the scan, we can conclude that no biopsy is needed, none and done. So with this study, we aim to improve the predictive accuracy of prostate cancer while reducing the number of biopsies. This study has the potential to significantly broaden our market opportunity, potentially doubling it. We see significant value in moving earlier in the care pathway by positioning our scan at the front of the patient journey. Next slide, please. Moving on to Pixclara. We've engaged with the FDA and agreed on a pathway forward and plan to resubmit the NDA. Recall that the FDA has granted Pixclara Orphan Drug and Fast Track designation, an acknowledgment of the drug candidate's importance in addressing a significant unmet medical need. Turning to Zircaix. Our PDUFA date is approaching next week. We view this as a transformative opportunity targeting an area with no approved therapies. If approved, Zircaix will be first to market, positioning us to lead in the space with significant unmet need for patients and commercial potential. So to summarize, we've built a robust commercial infrastructure that continues to deliver, highlighted by high single-digit growth for Illuccix in the U.S. We've secured marketing authorizations in 23 countries and successfully launched in the U.K. Gozellix, our next- generation PSMA agent, is now on the market with HCPCS reimbursement starting in October. Looking ahead, we have several near- term regulatory milestones, and then we believe our BiPASS study has the potential to redefine the diagnostic pathway in prostate cancer. So with that, I'd like to introduce you to Richard, who will provide you an overview of the therapeutic assets.

Thank you, Kevin. So let me present to you today the update of our Therapeutic business unit. And you will see that during the first half of this year, 2025, we were moving the needle on all our therapeutic areas. You can see on this slide, our strategic focus is centered around 3 therapeutic pillars: first, urology oncology; second, neurology oncology; and third, solid tumors and hematology. So within urology, we have a pipeline asset for prostate cancer and more specifically targeting the mCRPC standing for metastatic castrate-resistant prostate cancer. And also kidney cancer, we're targeting the ccRCC indication for clear cell renal cell carcinoma. But we have also a therapeutic agent such as TLX090 for metastatic bone pain deviation, which is frequent in the prostate cancer late stage. Within neuro-oncology, we have a pipeline asset for glioblastoma. And I'm happy to share that we are also adding a new indication for leptomeningeal disease with the alpha version of the TLX102 compound. Within our third pillar regarding solid tumors and hematology, we have the TLX400, our FAP-targeting asset that we closed the acquisition during the Q1 2025. This asset has the pan-cancer potential and we are exploring various indications. We also have molecules for soft tissue sarcoma and bone marrow conditioning agent for pediatric high-risk leukemia patients. I will come back on that in a minute. In summary, you can see that we have 10 early and late-stage assets. Late-stage assets, primarily focused on beta therapies, followed by earlier-stage assets exploring alpha therapies. In addition to these 10 assets, we also have preclinical compounds targeting for the most well-known DLL3 and alpha v beta 6 coming from the ImaginAb acquisitions. We are exploring the best combination with isotopes for these targets. Our diagnostic strategy includes having a companion diagnostic for all our disease area of focus, and we are working in close collaboration with Kevin and the precision medicine colleagues. Next slide, please. Let's talk about prostate as the first pillar of our urology strategy. TLX591 is our Phase III asset for mCRPC. And let me remind you that ProstACT GLOBAL is a combination trial with standard of care, namely we are associating the product with abiraterone, enzalutamide and docetaxel with 10 patients in each arm. This is a 2-part study where the primary readout from the Part 1 will be safety and dosimetry. And I'm pleased to disclose that we have reached target enrollment of 30 patients in the Part 1 and we'll provide an update once the data analysis is complete. Part 2 of the study is a randomized treatment expansion, including 490 patients. In order to accelerate ProstACT GLOBAL Part 2, firstly, we are currently in the process of getting the required regulatory approvals in various countries in order to expand the number of sites. Secondly, the protocol in Part 2 is more patient friendly in that the patients will not need to come back to the hospital for multiple scans, which were required in the Part 1 to complete the dosimetry data. Let's move on to TLX592, which is our next-generation PSMA targeting alpha therapy using actinium in development. Earlier this year, we presented data at ASCO GU from our clinical study evaluating the biodistribution and the dose to the organs of the copper-64 level imaging version. This was essentially a proof of concept of this asset and we are really looking forward to moving into Phase I. I'm pleased to say that we have now received the Human Research Ethics Committee approval in Australia for first-in-human study with this 592 asset. Let's move forward, TLX090, our Samarium agent. This is being developed to treat the pain palliation in patients that have osteoblastic metastatic disease. It fits nicely and perfectly with our urologic platform because frequently, the patients that have osteoblastic metastatic disease have prostate cancer. Currently, we are developing this as a single-dose agent for pain palliation, but there is potential in the future for multiple dose regimens as well. And I'm pleased to announce that we just received the FDA approval for Phase I study and look forward to start. It's another great milestone for this first half of the year 2025. I'm sure you can agree with me. Moving to the next slide. Our second pillar of the urology strategy is focused on kidney cancer. TLX250 is our CA9 targeting agent. We know that CA9 is expressed in greater than 90% of clear cell renal cell carcinoma. It's also being expressed in a number of solid tumors. We have a few ongoing studies exploring mono and combination therapy. We are focusing on monotherapy for advanced third and fourth-line patients with ccRCC. And I'm pleased to announce again that we are moving forward a pivotal trial named LUTEON with the submission completed to the Human Research Ethics Committee in Australia. On the right-hand side, you can see images. This is a patient with metastatic advanced renal cell carcinoma. On the top, you can see the initial images that have been performed with zirconium level girentuximab scan. You can see intense activity in the sacrum where there was a metastatic lesion. And after 3 cycles of therapy with lutetium girentuximab, you can see on the bottom row that the amount of activity in the sacral lesion has significantly decreased, again, giving us confidence that the injected therapy has made its way to the bone lesion. Now if we consider the life cycle of girentuximab compound, let's have a look to the TLX252, our CA9-targeting alpha therapy for pan-tumor approach, including ccRCC. When patients have high expression of CA9, they often face resistance to chemotherapy, immunotherapy and with time also radiotherapy. We think this is a good target for radioligand therapy because with an alpha isotope, we can use the increased activity directly targeting the tumor cells. We have submitted to the Human Research Ethics Committee application in Australia in late Q2 and look forward to start our Phase I trial once we receive ethics approval. Let's move to the next slide and moving to the neuro-oncology portfolio. I will start with the good news of receiving full ethics approval in Australia to start the IPAX-BrIGHT. IPAX-BrIGHT is a pivotal registration-enabling study in recurrent glioblastoma. Given the absence of effective options for glioblastoma, we are very pleased that this agent has been granted an Orphan Drug designation, both in U.S. and Europe for treatment of glioma. Our initial focus with PDX101 is going to be in glioblastoma, the most common and aggressive form of primary brain cancer. There is no established second-line treatment at this point. And if we look at the NCCN guidelines in U.S., it tells you that the clinical trial [indiscernible] is option for treating second-line patients with recurrent disease. Also, I just wanted to summarize data that we disclosed previously this year. IPAX-1 and IPAX-Linz in the recurrent setting demonstrated an acceptable safety profile as well as encouraging overall survival duration, both from the time of recurrent diagnosis ranging from 12 to 13 months and time from initiation of treatment from 23 to 32 months. It's a great achievement when we know the average life expectation, which is extremely reduced in this debilitating disease. On the right part of the slide, you can see a patient case coming from a compassionate use program in Europe. In this patient, the scans describe a stable disease for 18 months, very encouraging when you know the severity of this disease. Turning to our targeted alpha therapy approach in neuro-oncology, utilizing astatine isotope. We believe patients with smaller, more diffuse disease may be well suited with the mechanism of action and the higher energy deposition of astatine-211. We are currently in the process of preparing regulatory filing for submission for leptomeningeal disease and conducting a collaborative initiated -- investigator-initiated trial in glioblastoma. Let's move to the next slide, please. And focusing on the other solid tumors and hematology disease. Let's start with the TLX400, our FAPi, which stands for fibroblast activation protein inhibitor, an antigen expressed on the tumor microenvironment. The diagnostic piece has been confirmed in patients and we have several publications on the topic. We are looking forward to bringing this molecule to the clinic. The Phase I pan-cancer Basket study starting -- will start in 2026. The other 2 molecules we have are TLX300 in licenses from Lilly, PDGFR alpha for advanced metastatic soft tissue sarcoma. We have initiated a Phase I ZOLAR imaging trial that is recruiting patients in New Zealand and Australia. We also have the TLX66 for bone marrow conditioning for allogeneic stem cell transplantation, more specifically in myelodysplastic syndrome and acute myeloid leukemia. Let's move to the next slide. In conclusion, it is an extremely busy first part of the year. Telix has one of the most complete therapeutic portfolio with 10 pipeline assets and even a few more if I add some the research stage with ImaginAb recent acquisition. Within urology and neuro-oncology, we are progressing, initiating 3 pivotal trials. First, advancing the pivotal trial with ProstACT GLOBAL; second, preparing the pivotal trial LUTEON for the 250 compound and starting the pivotal trial IPAX-BrIGHT. We are also starting the clinical trial with the TLX090, which is the perfect companion product for our ProstACT portfolio. And I don't forget that we are entering first-in-human trials with our 2 alpha emitters, TLX592 and TLX252. Thank you for your attention.

Thanks very much, Richard. Great rundown and really conveys the depth of the pipeline and development activity and progress over the last 6 months. So as is typical, I get to end the presentation with a summary of our upcoming catalysts and key objectives. This is by no means an exhaustive list but captures some of the key value creation events that are on the near-term horizon. Many of these catalysts are new commercial opportunities that will add to our revenue and earnings growth and will support our expansion and transition into a fully-fledged theranostics company. Some of these catalysts relate to new clinical data points that I believe will reinforce our leadership position as an innovative player in the radiopharma space with pipeline of either best-in-class or first-in-class assets. Expanding our capabilities is a key driver of near-term value creation as we work to deliver our products into major global markets. Our investments are focused on building the operational strength needed to unlock these markets and then, of course, to scale sustainably. In closing, Telix continues to demonstrate strong growth and operational improvement. We've never been more focused or committed to delivering value for our shareholders, our clinical partners and most importantly, the patients we serve. Thank you for your attention. I hope you found this presentation interesting and informative, and I now open it up for questions.

[Operator Instructions] Today's first question comes from David Low with JPMorgan.

If we could start with just the outlook for gross margins. I mean I think it was very useful to get all the update on RMS (sic) [ RLS ] and understand exactly where the contribution is, but I heard the message that you think it can improve. And then, of course, we've seen some fairly significant changes in PSMA pricing in the last quarter, particularly the back end. I'm just wondering how that's going to play out and of course, trying to understand how Gozellix fits into that mix as well. So if I could have someone have a go at answering some of those facets, please.

Well, Darren, why don't you -- it sounds like 3 questions, not one, but why don't you go ahead, Darren, and start off with the gross margin.

Yes, sure. Thanks, David. Obviously, this half year has been quite a change for the organization where we've compared to the prior year where we're only selling Illuccix. And I think the first key point is that the Illuccix gross margin is -- and you can see this by looking at that precision medicine slide has remained fairly consistent. I think we reported 65% last year and 64% this year. So obviously, no real change in the gross margin perspective for Illuccix in the market from the gross margin. Then when we look at RLS, we see there the addition of those third-party products and also the kind of internal contribution that it received by selling our Illuccix product into the market that they're able to achieve a 7% gross margin once you've included the radiopharmaceutical -- sorry, the radiopharmacy cost into the cost of goods. The interesting thing we have done a little bit of benchmarking and what we found is the industry that's similar, some of our partners/ competitors are doing a very similar gross margin in that kind of low to mid-range single-digit yield. So gross margin is obviously a result of those 2 businesses brought together. So the 53% is the average based on the load of business. I think the important thing to remember, though, with RLS is that as we start to push a product like Illuccix and the higher contribution that it provides to the RLS business that, that should help grow the dollar gross margin for that business with little or minimal cost impact on being able to deliver that to patients. So what we would potentially see is as we add the more Illuccix and potentially the future products that we're looking to bring to market in Gozellix, Pixclara and Zircaix, that will continue to assist that business to make a better contribution to the organization. Hopefully, that kind of answers your question, David.

Yes. I think I don't have anything to add except for that, obviously, we didn't acquire RLS for its commodity radiopharmaceutical business. We acquired it to put a larger proportion of our own products through and to prepare for when we have to distribute therapeutic unit doses, which you can't do that without a nuclear pharmacy dose dispensing. If you want to deliver a prefilled syringe to a customer, which is the name of the game, you got to have a pharmacy network to do that. So this is not about like what's going to happen this quarter. It is what's going to happen in the next quarter and the quarter after that and 3 years from now. So let's move on to the next question.

The next question comes from Tara Bancroft with TD Cowen.

This is Nick on for Tara. I have one on the guidance and the continued growth of Illuccix moving forward. So to reach the 2025 guidance with assuming stable RLS revenue, obviously, it's a little bit difficult to say that right now. But it appears like Illuccix sales growth may be slowing a little bit. Is this due to the loss of pass-through status? And what impact could this have on Illuccix net sales? Also, could Gozellix need to return to growth once it does have pass-through status?

Yes. I mean, obviously, we give guidance on an annualized basis, not on a quarter-by-quarter blow. So you're absolutely correct. 1st of July, we came off pass-through. We actually reported 7% growth quarter-on-quarter, which is, I think, exceptional -- 7% growth in volume quarter-on-quarter, which is really exceptional performance if you -- particularly if you take some of our competitors' financial results into consideration. So what we did is we made a decision that we were going to stabilize our customer book going into the third quarter. We have the situation where we have one product coming off pass-through and then another product getting reimbursement effective 1st of October. And we've got to bridge that gap and we chose to take certain commercial actions to do that. And we still had growth in revenue quarter-on-quarter, again, where our competition didn't. And so I think we have a nice stabilization strategy for Q3 and then Q4 continues with the advantage that we uniquely have of a second product introduction. I don't know, Kevin, if you want to add anything to that?

I would just add that we just continue to take the market pragmatically and continue to sell clinically on our accuracy as we spoke of earlier in my presentation and then continue to drive that message with reliability. And again, we have a strategic pillar and our customer-facing team that really represents well and is able to really manage that ASP and volume mix that we work on with that piece of the business and the strategic accounts.

Yes. And I think you'd be mistaken in thinking that this is just a pricing game. It's not. I think there's 4 pieces to commercial success in the market dynamic today, as Kevin said, selling on clinical value proposition, which we have demonstrably the strongest clinical value proposition. It's selling on service and service quality. Then there is, of course, pricing and pricing structure, particularly for large volume customers. Unlike our competition, we don't throw it all at the same price to everybody. We give benefits to our customers that are more loyal than smaller customers. And I think the last thing is clearly reimbursement status. And again, to reiterate, we go into Q4 with a very strong and differentiated commercial strategy with Gozellix. And we're excited about that. We're looking forward to it. Sales team is pumped.

Our next question comes from David Dai with UBS.

Congrats on the quarter. I'm just curious about the Zircaix launch readiness. Maybe you can highlight some of the things you've been doing for Zircaix and how should we think about the launch in the first and the second quarter after approval on August 27?

There's probably not too much to really kind of openly discuss. I mean the commercial team, it's not their first rodeo. We're selling into the same customer base, same referral physician base as Illuccix. So it's a very straightforward pathway to the customer. We're clearly focused on using our Illuccix customer base to seed that product launch. And I would say commercial team is ready to rock and roll on Zircaix. I don't know if you want to add anything to that, Kev?

No, I think the combination of a urological call point with a nuclear med physician base that's reading that is really the key to success there. And we've had an expanded access program going for a while that's demonstrated exactly what we saw in the ZIRCON study. So we're excited about the launch and just haven't given guidance for 2026 yet.

Yes. I mean we've had a lot -- the expanded access program, the EAP has been a huge success. We've done a very, I think, well- orchestrated unbranded physician education campaign. So as far as we're concerned, the market is ready for this product.

The next question is from Andy Hsieh with William Blair.

Congratulations on the performance. So for the BiPASS study, obviously, very provocative in terms of the disruptive potential. I'm curious, the trial is posted on ClinicalTrials.gov. You have some primary endpoints. Just curious about some secondary endpoints that you're contemplating on and how you think about some of the outcomes, longer-term outcomes for patients pertaining to survival or treatment steps that you can really, really convey the value of taking this agent upfront?

Yes. So this study was really born out of and driven by KOL engagement around where is PSMA going to really go as we move up the treatment cascade. And to be quite honest with you, on the front line of patient management, not a lot has really changed in the last sort of 15 years. It's pretty archaic. And whilst MRI, of course, gets better and better, we're still doing well over 1 million biopsies a year and a good proportion of those biopsies aren't adding any value to the patient journey. So just to be clear, our goal is not to eliminate biopsy. I mean that's a nonsensical clinical objective. A biopsy is super important. What our goal is, is to make biopsy count and to use it where it's absolutely essential and to use the scope of biopsy where it absolutely makes sense to do that. In terms of the -- we will, of course, be putting out the trial design on ClinicalTrials.gov. It's only just -- that study is just launching. So clearly, we want everybody to understand the endpoints. But to the implied part of your question, yes, there will be a monitoring period. It won't be a very long monitoring period, but there's definitely a follow-up period that's part of the evaluation of the utility of prostate imaging in that patient segment. So stay tuned, Andy, we've got more updates on that trial design coming down the pathway.

The next question comes from David Nierengarten with Wedbush Securities.

I just had one on the ProstACT study. Just around the parameters, you've recruited the patients. Kind of what are you looking for on the dosimetry and safety side? And when you think about the movement into the Part 2 of the study, is it still the plan to carry forward all 3 combinations? Or could that change in the future when you talk about the results from these first 30 patients?

Well, things can always change based on data. But we -- at present, our plan remains as stated. The real purpose of the Part 1 study and frankly, the reason why it took a while to accrue is because it's a multi-time point specto dosimetry, a lot of patient visits involved, typically requires specialist centers. So it's really a subset of departments that are really suitable for running that study. And it is, as I said, it's a demanding study on patients. We know that when we move into the second part of the study, which in some countries is a seamless transition. So that's already in play. It's a very straightforward transition and a much more straightforward study protocol from a patient perspective. And the 3 different arms were because we had the aspiration in this study to have flexibility on the choice of RP. We think that, that's an important thing. And so really, what we're looking to get out of Part 1 is confirmation of our understanding of the safety profile in combination with both RPs, different RPs and Taxanes. We fully expect that, that's what's going to progress into the second part of the study. We think that there's a compelling clinical use case for all 3 of those combos and our mission is to really demonstrate to the agency that, that safety profile is consistent across -- really across different RPs. So I hope that answers your question, but we're really excited to have that first run-in part done. It was a pretty painful study protocol. The rest of the study now is going to pick up at a much greater pace.

The next question comes from John Hester with Bell Potter.

I want to just come back to the situation with PSMA pricing. I'm sure everyone on the call heard the comments from Lantheus a few weeks ago regarding the competitive situation and also Kevin referred to competitive pricing pressures in the market in his prepared comments. So the question is this, are you worried about that pricing pressure contagion spreading to your own market? And can you also sort of update perhaps on what you've seen on those pricing pressures in this current quarter?

Well, I think we've reported all the numbers. So the numbers are the numbers. I think that pricing is a direct function of both competitive dynamics and clearly, reimbursement status. The market is complicated. As you know, there are multiple customer segments in the market that have different competitive dynamics and different pricing dynamics. What we do know is that customers prefer understandably to use a reimbursed product. Lantheus came off reimbursement, and that certainly puts pressure on their business. We've now come off reimbursement, albeit for a very transient period of time because we have been granted a HCPCS code for our life cycle management product. which, by the way, has innovative aspects in its own right. Like it's not just a direct follow-on. There's some genuine clinical and clinical workflow benefits that comes from that product. So the way that we manage pricing and pricing consistency is by ongoing innovation and capability delivery to our customers and differentiating ourselves in that -- in both the clinical use case for the product and the reimbursement profile of the product. And so -- and I don't want to sound facetious, but no, pricing pressure is not what we worry about because we have a life cycle management strategy to address it.

Today's last question will come from Andy Hsieh with William Blair.

So Chris, I'm just curious if you can comment a little bit more about the aluminum fluorine technology that you mentioned that kind of allows you to traverse between the gallium-68 and fluorine-18 isotopes. Can you speak to maybe the commercial implication, i.e., what is the next steps in terms of potential regulatory pathway and then supply chain, how does that kind of fit into your goal of being a vertically integrated company, leveraging the RLS and ARTMS platforms?

Well, on the node, so I'll start off with the science lesson, and then I'll hand it over to Kevin to talk about the commercial implications and the physician preference. But essentially, when you react aluminum and fluorine together, it's pretty violent coupling. And what you end up with is a metallized version of F-18. And it turns out that, that metallized version of F-18 is a drop-in replacement for gallium. So what it means is that you have the same targeting agent with the same chelator and you can interchangeably substitute either gallium or F-18. And the beautiful thing about aluminum fluoride is that you make it in extremely large quantities at a cyclotron facility. It's not a drug per se. It's essentially an API, a hot API. And you can drop that activity then into nuclear pharmacy and using all of the benefits and the production workflow advantages that we have of the kit-based approach we can essentially, particularly in high-density areas or where we want to service large academic customers that really are enamored by F-18, and I'll get Kevin to characterize the customer base a bit more, but it enables us to seamlessly transition between gallium and F-18 and of course, continue that life cycle management. And PSMA-11is really well demonstrated in terms of its sensitivity and specificity as a targeting agent. And now we get to marry that kind of superior pharmacology of PSMA-11 with the utility of F-18. And still, by the way, utilizing our well-trodden and well- understood distribution model. Maybe, Kevin, you want to comment on physician preference?

Sure. So as you know, we launched Illuccix 3 years ago and we've successfully taken over 1/3 of the market, pushing 40% of the market with gallium. And we believe that gallium is a fantastic product and we're going to continue to execute on our Illuccix and our Gozellix plan through the marketplace. But what we do see is some stalwarts that have used F-18 for many other products through the years and tend to favor that more. The reality is that we believe our reliability story, along with our commercial customer-facing team can support that in the next couple of years as we move from -- in our life cycle management from Gozellix and continue to maximize gallium cells and then find, if you will, the corners of the canvas, if you will, to paint with AlF, and we believe that's a great product to do it through our distribution and commercial network.

Yes. So maybe just to wrap up because it's a super great question. And by the way, you're the first analyst that's ever asked a question about it. So that's why I'm grateful to elaborate a bit more. But going forward, I think what you're going to really see is we have a whole pile of imaging products coming down the pike, including, for example, there's a gallium FAP agent there. As we develop that agent, we'll think about how this time do we avoid having to participate in a physician preference discussion, right? Some folks like gallium, some folks like F-18. Some guys drive the beamer, some guys drive the Mercedes. And we're going to set up shops so we can make both available depending on what the preference is. All right. Well, look, I think Yes, I think we're at the end of time anyway. Well, thanks -- I just want to say thanks very much to everybody for your time today and I appreciate the opportunity to give you an update. Thanks very much.

That does conclude our conference for today. Thank you for participating. You may now disconnect your lines.

Thank you for standing by, and welcome to the Telix Half Quarter 2025 Results and Investor Webcast. [Operator Instructions] I would now like to hand the conference over to Ms. Kyahn Williamson. Please go ahead.

Thank you and everybody, for joining us this morning and this evening for those joining from overseas. My name is Kyahn Williamson. I'm the SVP of Investor Relations and Corporate Communications at Telix. You can see there our disclaimer. Just moving forward to Slide 4. I'd like to introduce today's speakers that are on the line with me. We have Chris Behrenbruch, our Group CEO and Managing Director; Darren Smith, our Group Chief Financial Officer; Kevin Richardson, CEO of Telix Precision Medicine; and Richard Valeix, CEO of Telix Therapeutics. Today, we'll be taking you through the H1 2025 financial results presentation lodged earlier today on the ASX and our operational achievements for the half. This call is scheduled to run for 1 hour. And following the presentation, we'll take questions firstly from analysts on the phone and request that you ask one question at a time and hop back in the queue if you have further questions. If we do not get to your questions on the webcast, we will reply to you directly. Moving on to Slide 5, please. In today's presentation, our business leaders will be talking to the investments we have made in the business to set it up for long-term value creation. This slide illustrates the scale of our business today, spanning development, commercialization and global production and manufacturing. It's been a rapid transformation. This time last year, we had one approved product, Illuccix, which was commercial in just a handful of companies. Today, we have multiple approved products. We are preparing to roll out Illuccix across Europe and are preparing for launch of Zircaix and Pixclara. The acquisitions we have made have seen our manufacturing and distribution sites grow to 38 and our workforce has more than doubled with now over 1,000 employees globally. Next slide, please. We've previously presented our growth strategy that is in place to drive value creation for the long term. You can see the 4 pillars on the left-hand side of the slide and the achievements we have delivered against each one this half. These pillars are to grow our precision medicine or commercial stage imaging business and the achievements this half are focused on the goal to grow our share in the PSMA market and bring new products to patients. Kevin will discuss this further. Delivering on our late-stage therapeutics pipeline and building our next-generation pipeline, including alpha therapy candidates. This half, we have made solid progress across an array of programs, which Richard will take you through in more detail. And finally, the expansion of our global delivery infrastructure, a key highlight this half has been the integration of the RLS business. Chris will take you through this and the key value drivers aligned to our strategy. Firstly, however, Darren will talk you through the financial results for H1 2025 in more detail. So I'll hand over to you, Darren.

Thanks, Kyahn, and welcome, everyone. From a financial perspective, the first half of 2025 was characterized by strong commercial growth in our Precision Medicine business and continued investment into building our business for the future. We delivered strong revenue growth in the first half of 2025 with group revenues improving 63% year-on-year and driven by growth in Illuccix and the addition of third-party revenue from RLS. Our precision medicine revenues were up 30% year-on-year with EBITDA improving 24%. Gross margins in our Precision Medicine business remained stable at 64%, reflecting efficient manufacturing of Illuccix. The group's gross margin was 53%, reflecting the addition of RLS third-party product mix and the associated manufacturing and distribution costs. In this half, we have made a significant investment into our global manufacturing infrastructure to ensure that we are well positioned for long-term growth and we continue to invest in our R&D pipeline with investment up 47% year-on-year. Following these investments, we generated $18 million in operational cash flow and finished the half year with a healthy $207 million cash on hand. Now moving to the next slide and our group revenues. Telix generated revenues of $390 million. This consisted of $79 million in revenues from RLS third-party sales and $311 million mainly from our Precision Medicine business. This represents an increase of 63% year-on-year and 41% compared to the second half of 2024. Illuccix continues to deliver strong growth, especially as it relates to volume doses. Kevin will provide more detail later in the presentation. Now moving on to the next slide on the group P&L. As stated previously, the group P&L represents a period of solid growth and strategic investment into preparation for delivering future long-term growth. Group gross margin landed at 53% following the addition of RLS third-party products and RLS associated manufacturing and distribution expenditure. R&D increased 47% to $82 million. As planned, we increased our investment into our therapeutic pipeline to be 54% of our overall investment in R&D from 43% last year. Richard will talk to our therapeutic portfolio later in the presentation. Selling and marketing expenses increased to 13% of revenue from 10% last year as we prepared for the product and geographic expansion of our Precision Medicine business and the addition of $7 million in selling and marketing expenses from RLS. Manufacturing and distribution expenditure, excluding RLS COGS increased to 5% of revenue from 4% last year, driven by investment in our manufacturing and distribution infrastructure in ARTMS, Iso Therapeutics and multiple TMS facilities. General and administration expenses decreased to 12% of revenue from 16% of revenues last year. As a result, adjusted EBITDA declined to $21 million, driven by our investments. Now moving on to the next slide. This slide represents the income statement of our Precision Medicine business. As you can see, gross margin is steady at 64%. This indicates that we have maintained our operational efficiency of Illuccix, enhancing our ability to reinvest in growth. As planned, we prepared for new product launches and geographic expansion, increasing selling and marketing expenses to 12% of revenue, facilitating the build-out of our commercial infrastructure ahead of the expected revenue growth. This increase was offset by reductions in percentage of revenue spend on R&D and general and administration. As a result, the precision medicine EBITDA improved $20 million year-on-year, driven by 29% revenue growth. Moving to the next slide of our TMS business. Moving on to the next slide. As we have made significant investments into TMS, I thought it was important to provide details, in particular, the contribution of RLS, which we are reporting for the first time. RLS is the largest component of the TMS business, employing over 500 people across more than 30 locations, integrating last-mile delivery capabilities for Telix. In the next 5 months -- sorry, in the 5 months since acquisition, RLS EBITDA was close to breakeven. The addition of further volumes of Telix's products through RLS will improve the contribution. RLS currently processes 1/3 of Telix's group revenue with total network revenues for the 5 months being $110 million. This includes $79 million of third-party products and $31 million of intersegment revenues related to Illuccix. Gross margins for RLS were 7%, which is typical for this type of business and includes manufacturing and distribution costs from the radiopharmacies. RLS operating expenditure, excluding COGS for the 5 months since acquisition totaled $15 million. We expect these costs for the second half of 2025 to remain at a similar percentage of revenue. Our TMS business also includes various subsidiaries such as Iso Therapeutics, ARTMS and TMS Brussels, Melbourne, Oklahoma, Sacramento, where we increased our investment to advance operational activities at each of these sites. Chris will expand on the TMS strategy later in the presentation. Now moving on to the group's cash flow. In the first half of 2025, Telix has again achieved a positive operating cash flow totaling $18 million, demonstrating the ability of the commercial business to fund the development of our R&D pipeline and funding preparations for market and product expansion. As previously mentioned, Telix utilized cash on hand to make a number of strategic acquisitions. The largest of this was RLS. Cash on hand at the end of June was a healthy $207 million. Now moving on to the next slide. I'd like to take a moment to go over our capital allocation priorities. Telix is focused on 4 areas: firstly, R&D development; secondly, optimizing our commercial performance; third, strategic growth opportunities through M&A; and fourth, supply chain resilience and production capacity. We believe these 4 areas of focus will enable us to deliver long-term growth. Within R&D, we are advancing several late-stage clinical programs and we are optimizing our commercial infrastructure to advance our commercial assets and expand into new areas of focus and geography. In terms of M&A, we invested in 3 strategic assets in the first half of 2025. They were RLS Radiopharmacies, ImaginAb and a FAP candidate. We continue to invest strategically into our manufacturing and supply chain infrastructure to preserve our competitive edge and to ensure we are in a position to scale efficiently as demand grows. We do all of this in a disciplined way by ensuring that we have a prudent cash buffer on our balance sheet. Now moving to my final slide. As stated on this slide, we are reaffirming our full year revenue and R&D guidance. We expect our revenue from Illuccix and RLS to be in the range of $770 million to $800 million. Our R&D investments, we expect to fall in the range of 20% to 25% increase on last year. Finally, I'd like to take the opportunity to reiterate our investment strategy. For the next 3 years, we will grow revenues by advancing assets from clinical development to commercialization, expanding indications and geographic expansion. We will reinvest the earnings into our portfolio and ensure that we have the capabilities, infrastructure and readiness to deliver on our therapeutic programs. At this stage of our development, our priority is building long-term asset value rather than optimizing near-term EPS growth. We believe that focus on earnings too early can be troughed from the strategic investments needed to unlock the full potential of our pipeline. I'll now hand you over to Chris Behrenbruch, Managing Director and Group CEO. Thank you.

Thanks very much, Darren, and good day to everybody online. So I'd like to start by taking a moment, if you could advance on to the next slide, please, to talk about why Telix is highly differentiated and built for long-term success. Starting with our therapeutics pipeline. Our pipeline is built around areas of high unmet medical need with a diversified portfolio strategy that gives us multiple shots on goal, even in some cases, concentrated in the same disease area. Our R&D efforts remain sharply focused on advancing next-generation assets, whether that's in the alpha or beta therapies, novel isotopes or innovative targeting agents. As a data-driven organization, our decisions are grounded in rigorous scientific and clinical evidence, ensuring that we prioritize our limited resources towards the most promising opportunities. Turning to manufacturing and supply chain excellence. I want to emphasize that radiopharmaceutical manufacturing and distribution is an extremely complex business from an operational quality and regulatory perspective. A robust, reliable supply chain is critical to long-term success, especially for a multiproduct portfolio like ours that's also going to one day deliver therapeutic outcomes. This is why we've made strategic investments in selective aspects of vertical integration over the past couple of years, alongside deepening relationships with key strategic partners that we think are best aligned with our long-term commercial strategy. Our investment in commercial infrastructure is starting to deliver real operational and financial returns, including with continued volume growth for Illuccix in a maturing market landscape. This performance reflects our proven track record in commercial execution and I think it positions us very well for future product launches. This year also marks a major inflection point for Telix as we transition from effectively a single product, single market company to a multiproduct, multi-region commercial organization. And we've done it pretty cost effectively. With this global infrastructure in place, our precision medicine assets are laying the operational and financial foundation for the rollout of our future therapeutic pipeline, which, as a reminder, is really not that far away. Next slide, please. So within prostate cancer, our multiproduct strategy supported by next-generation follow-on assets is designed to drive sustained revenue growth. This approach strengthens our market position while expanding our commercial runway. We may have been second to market with Illuccix, but we are leading our new strategy through a life cycle management initiative that will enable us to continue to capture market share and to compete on the merits of our product portfolio to dramatically reduce the impact and viability of new entrants. We'll continue to expand the market -- we'll continue to expand the market through new indications and indication expansion, notably our BiPASS study, a groundbreaking Phase III study that's aimed at expanding the label to use Illuccix and Gozellix right to the front of the patient journey with the potential to disrupt current diagnostic pathways and significantly expand the total addressable market. Kevin is going to talk more about this exciting near-term opportunity during his part of the presentation. Finally, we continue to focus on product innovation, leveraging the strength of our distribution model, customer service and innovation focus to maximize product choice to the benefit of physicians and patients. For example, we recently unveiled the AlFluor chemistry program. This first application -- the first application is the development of a PSMA targeting agent that enables us to combine the imaging benefits of fluorine-18 with the convenience of gallium kit-based workflows the market has already come to appreciate. We have an extensive clinical data package to support this, including a Phase III study in a significant number of patients. Following a helpful consultation with the FDA, we are now planning a registration-enabling study to take this forward to a new drug application. Next slide, please. Let's take a moment to understand what transitioning from a single product, single market company to a multiproduct, multi-region commercial organization actually means. It takes a highly complex global manufacturing and distribution infrastructure to deliver our precision medicine assets and obviously, future therapeutics that are coming down the pathway to patients. Due to the relatively short half-lives of isotopes and the need for just-in-time manufacturing, highly specialized facilities and logistics are required to avoid factors throughout the journey that can lead to disruption and delays. We have continued investing in our manufacturing infrastructure globally to have greater control throughout the process and significantly reduce quality and delivery risk. We see this as a crucial point of competitive advantage because without reliability, there is no commercial traction in this industry. Our global footprint -- global footprint reflects our commitment to leadership in radiopharma. We believe a truly global presence is critical to becoming and maintaining market leadership in this space. Next slide, please. On the topic of RLS integration, the RLS acquisition was a highly strategic investment, enhancing our U.S. presence, which is a critical market with a production and distribution network that covers over 85% of the U.S. and provides last-mile delivery and a footprint to expand our manufacturing capability in the U.S. Darren has already talked to the financial contribution of RLS. I want to touch on the value drivers and integration progress to date. In just 5 short months, the integration is going very well, and I have been personally extensively involved in the process alongside Darren Patti, Telix's Group COO. RLS can deliver value in the following ways. Firstly, we are already seeing the synergies of having 2 distinct commercial teams that complement each other in terms of the way that they view and engage with the market. Having a nuclear pharmacy network provides a new entry point and insights, bringing us closer to the customer and enabling us to identify significant new opportunities. To be clear, our team manages everything from producing the end dose, quality controlling it to walking it into the clinical site. This business is all about service to the end customer. Second is a pathway to margin improvement. The volume of Illuccix sales through the RLS network has increased by 50% on a dose volume basis in the first 6 months since the acquisition. This is not at the expense of our key partners, rather it demonstrates the synergies between the 2 commercial organizations and our ability to capture commercial white space and optimize our competitiveness. PET agents like Illuccix and Gozellix reflect higher-margin, higher-value products for nuclear pharmacies to distribute. As we increase product distribution of our own products through RLS, we expect to see long-term improvement in gross margins and the ability to mitigate competitive and distributor risk. Finally, our goal with RLS is to build a radio metal production network to meet future demand for imaging and therapeutic radiopharmaceuticals to grow the RLS business, but also to reduce our own reliance on third parties for supply chain in the U.S. Again, with this investment, we will be focusing on high-margin products, not historical commoditized products. We are currently in facilities planning and development for 6 cyclotrons across the RLS network initially with the facilities upgrade process to commence in the second half and will be complemented by in-house capabilities to produce select therapeutic products alongside our pharmacy production function for dose drawing and dispensing. So this will support both commercial activity and clinical activity. Next slide, please. So the third part -- third pillar of value creation that I want to touch on is our therapeutics pipeline and platform. We are deeply committed to bringing our therapeutics to the market and this ambition remains a central focus of our investment strategy. As you heard from Darren, it's a growing proportion of our R&D expenditure. We are making meaningful progress across the entire pipeline and the momentum we're building reflects the strength of our execution. I'm going to let Richard speak more about our progress generally across the pipeline. With the acquisition of Los Angeles-based ImaginAb, we acquired a biologics and drug development platform that's really well optimized for targeted alpha therapies. This is an incredibly talented team of people with a huge amount of experience backed by key opinion leaders that have a great vision for what the future targeting platform will look like in radiopharma. The acquired platform uses small engineered biologics or antibodies that enable highly specific cancer targeting combined with fast tumor uptake and blood clearance. With our capabilities in antibody engineering, linker and chelator optimization and isotope selection, we're really well positioned to develop highly potent and targeted radiopharmaceuticals that range from small molecules all the way to advanced biotherapeutic products. We believe these specialist in-house R&D capabilities are fundamental for long-term success of the company. So the next slide, please. So just to wrap up in terms of expectations around top line and bottom line growth and reiterating some of the messages that Darren has given you, I've been showing this chart in our investor presentation since the start of the year and there are some important signaling aspects to this graphic. We are now in the middle stage of our trajectory where we're diversifying our revenue streams, expanding globally and derisking the business. If you recall, our midterm strategy has been to reinvest our revenues into the business to fuel long-term growth. We're making very targeted investments today to position the company for long-term growth, both in top line expansion and bottom line performance. But right now, it's without putting every last dollar into that growth and infrastructure that when we hit our pre- commercial launch year for the Therapeutics business, we are really ready to go. I want to give a little final comment before I hand over to Kevin and take a moment to address the information request from the SEC. I know many people have had questions about it. I'm personally disappointed to be in the situation as I really don't believe it reflects the quality of our organization or our commitment to excellence. The subpoena was a request for documents primarily relating to our disclosure activity related to the development of our prostate cancer therapeutic candidates. We are in the process of responding to the SEC to resolve this as soon as possible. I want to make clear that there have been no allegations or charges leveled at the company or any individuals. We do not know what or who triggered this. Let me be clear, this has no impact on our commercial portfolio or the momentum of our pipeline development. In fact, we're operating with more urgency and focus than ever before to bring these breakthrough assets to patients. I believe you can see evidence of this progress in today's presentation. So with that, I'd like to transition over to Kevin, our CEO of Precision Medicine for a commercial update. Thanks, Kevin.

Sure. Thank you, Chris. And for my first slide, I would like to start with our precision medicine growth strategy. Our growth strategy is based on 3 pillars: expand product offerings, expand geographies and then expand indications on those products. In terms of our first pillar, expanding our product offerings, we have now launched Gozellix, further strengthening our position in the PSMA space. And looking ahead, we have 2 near-term regulatory milestones with Zircaix and Pixclara. These assets will build on our strong commercial foundation established by Illuccix. Moving on to our second pillar. The global rollout of Illuccix continues to progress well with marketing authorizations now secured in over 23 countries. Turning to our third strategic pillar. We are actively exploring new indications for our existing assets, particularly indications where we believe we can deliver meaningful impact for patients. We remain laser-focused on the execution of these 3 strategic pillars, driving the expansion of our global Precision Medicine business and paving the road for our Therapeutics business. Next slide, please. Illuccix continues to deliver strong growth in the high single digits. In the second quarter, Illuccix revenues were up 2% quarter-over-quarter or 25% year-over-year with dose volumes up 7%. Q2 represents the highest unit volume growth we've seen in the last 5 quarters. And despite competitive pricing pressures, we continue to manage the impact to our average selling price. To do so, we continue to drive share growth in clinical accuracy and reliability of dose delivery. Our clinical message is Telix PSMA gallium agents have fewer indeterminate bone lesions and higher inter-reader agreement than F-18 assets. We couple the clinical message with a highly specialized sales force and customer-facing teams that differentiate Telix with our customers every day. We've developed a reputation in the marketplace as an innovator, paving the way for successful launch of our follow-on products. Next slide, please. Moving on to geographic expansion and the global rollout of Illuccix. As you can see, we've established a strong commercial footprint across key markets, including the U.S., Canada, Australia, Brazil, the U.K. and Europe with marketing authorizations now secured in 23 countries. In the second quarter, we successfully launched Illuccix in the U.K. and see encouraging uptake. In the next wave of launches, we are focused on key markets like France, Germany, Italy and Spain. And as you move further east, we're focused on China and Japan, where in China, we have completed our registration study and are preparing an NDA for Illuccix. While in Japan, we are just initiating our Phase III study for Illuccix, and we are happy with the progress thus far. Now on to Latin America, where we have the first approved product for PSMA PET and we have commenced commercial operations there with our partner on the ground. Overall, we remain on track with the global rollout of Illuccix, supported by strong execution in the U.S. Next slide, please. We launched Gozellix earlier this year and successfully delivered our first commercial doses in June. The launch is progressing well through our comprehensive network of distribution partners, Cardinal Health, Pharmalogic, Jubilant and RLS. Telix is the first company to bring 2 PSMA-targeted agents to the market, a differentiated strategy that we believe is central to our competitive advantage. This dual product approach gives customers meaningful choice, whether in terms of economic value or scheduling flexibility and it reinforces our commitment to meeting diverse clinical and operational needs. Now from a reimbursement point of view, we are pleased with the recent HCPCS code we received from CMS, a major reimbursement milestone and look forward to getting an update on the decision around transitional pass-through status in the near future. The HCPCS code will be effective October 1, 2025, streamlining the billing and reimbursement in the hospital outpatient setting for Medicare-eligible patients. Next slide, please. Moving on to our third pillar of growth strategy, label expansion. I wanted to talk about a study that we think has the potential to become the future of prostate cancer diagnosis, our BiPASS biopsy study or biopsy of the prostate avoidance stratification study. Biopsy are highly invasive and carry risk and there are more than 1 million patients getting a biopsy every year with up to 75% of them being negative. When you think about it, what it takes to really be disruptive in this space and be innovative, we think it's minimizing patient trauma, reducing risk and recovery time and lowering cost while improving patient outcomes. Next slide, please. BiPASS is the first registrational study combining MRI and PSMA PET in diagnosing prostate cancer. Patients are categorized into high, medium and low-risk categories for prostate cancer. And for high-risk category, an image-guided biopsy would be recommended. For the intermediate or an indeterminate category, a precision biopsy would be recommended since PSMA is much more sensitive in the detection of prostate cancer and we can perform one and done. For the low-risk category, if there is no uptake of PSMA in the scan, we can conclude that no biopsy is needed, none and done. So with this study, we aim to improve the predictive accuracy of prostate cancer while reducing the number of biopsies. This study has the potential to significantly broaden our market opportunity, potentially doubling it. We see significant value in moving earlier in the care pathway by positioning our scan at the front of the patient journey. Next slide, please. Moving on to Pixclara. We've engaged with the FDA and agreed on a pathway forward and plan to resubmit the NDA. Recall that the FDA has granted Pixclara Orphan Drug and Fast Track designation, an acknowledgment of the drug candidate's importance in addressing a significant unmet medical need. Turning to Zircaix. Our PDUFA date is approaching next week. We view this as a transformative opportunity targeting an area with no approved therapies. If approved, Zircaix will be first to market, positioning us to lead in the space with significant unmet need for patients and commercial potential. So to summarize, we've built a robust commercial infrastructure that continues to deliver, highlighted by high single-digit growth for Illuccix in the U.S. We've secured marketing authorizations in 23 countries and successfully launched in the U.K. Gozellix, our next- generation PSMA agent, is now on the market with HCPCS reimbursement starting in October. Looking ahead, we have several near- term regulatory milestones, and then we believe our BiPASS study has the potential to redefine the diagnostic pathway in prostate cancer. So with that, I'd like to introduce you to Richard, who will provide you an overview of the therapeutic assets.

Thank you, Kevin. So let me present to you today the update of our Therapeutic business unit. And you will see that during the first half of this year, 2025, we were moving the needle on all our therapeutic areas. You can see on this slide, our strategic focus is centered around 3 therapeutic pillars: first, urology oncology; second, neurology oncology; and third, solid tumors and hematology. So within urology, we have a pipeline asset for prostate cancer and more specifically targeting the mCRPC standing for metastatic castrate-resistant prostate cancer. And also kidney cancer, we're targeting the ccRCC indication for clear cell renal cell carcinoma. But we have also a therapeutic agent such as TLX090 for metastatic bone pain deviation, which is frequent in the prostate cancer late stage. Within neuro-oncology, we have a pipeline asset for glioblastoma. And I'm happy to share that we are also adding a new indication for leptomeningeal disease with the alpha version of the TLX102 compound. Within our third pillar regarding solid tumors and hematology, we have the TLX400, our FAP-targeting asset that we closed the acquisition during the Q1 2025. This asset has the pan-cancer potential and we are exploring various indications. We also have molecules for soft tissue sarcoma and bone marrow conditioning agent for pediatric high-risk leukemia patients. I will come back on that in a minute. In summary, you can see that we have 10 early and late-stage assets. Late-stage assets, primarily focused on beta therapies, followed by earlier-stage assets exploring alpha therapies. In addition to these 10 assets, we also have preclinical compounds targeting for the most well-known DLL3 and alpha v beta 6 coming from the ImaginAb acquisitions. We are exploring the best combination with isotopes for these targets. Our diagnostic strategy includes having a companion diagnostic for all our disease area of focus, and we are working in close collaboration with Kevin and the precision medicine colleagues. Next slide, please. Let's talk about prostate as the first pillar of our urology strategy. TLX591 is our Phase III asset for mCRPC. And let me remind you that ProstACT GLOBAL is a combination trial with standard of care, namely we are associating the product with abiraterone, enzalutamide and docetaxel with 10 patients in each arm. This is a 2-part study where the primary readout from the Part 1 will be safety and dosimetry. And I'm pleased to disclose that we have reached target enrollment of 30 patients in the Part 1 and we'll provide an update once the data analysis is complete. Part 2 of the study is a randomized treatment expansion, including 490 patients. In order to accelerate ProstACT GLOBAL Part 2, firstly, we are currently in the process of getting the required regulatory approvals in various countries in order to expand the number of sites. Secondly, the protocol in Part 2 is more patient friendly in that the patients will not need to come back to the hospital for multiple scans, which were required in the Part 1 to complete the dosimetry data. Let's move on to TLX592, which is our next-generation PSMA targeting alpha therapy using actinium in development. Earlier this year, we presented data at ASCO GU from our clinical study evaluating the biodistribution and the dose to the organs of the copper-64 level imaging version. This was essentially a proof of concept of this asset and we are really looking forward to moving into Phase I. I'm pleased to say that we have now received the Human Research Ethics Committee approval in Australia for first-in-human study with this 592 asset. Let's move forward, TLX090, our Samarium agent. This is being developed to treat the pain palliation in patients that have osteoblastic metastatic disease. It fits nicely and perfectly with our urologic platform because frequently, the patients that have osteoblastic metastatic disease have prostate cancer. Currently, we are developing this as a single-dose agent for pain palliation, but there is potential in the future for multiple dose regimens as well. And I'm pleased to announce that we just received the FDA approval for Phase I study and look forward to start. It's another great milestone for this first half of the year 2025. I'm sure you can agree with me. Moving to the next slide. Our second pillar of the urology strategy is focused on kidney cancer. TLX250 is our CA9 targeting agent. We know that CA9 is expressed in greater than 90% of clear cell renal cell carcinoma. It's also being expressed in a number of solid tumors. We have a few ongoing studies exploring mono and combination therapy. We are focusing on monotherapy for advanced third and fourth-line patients with ccRCC. And I'm pleased to announce again that we are moving forward a pivotal trial named LUTEON with the submission completed to the Human Research Ethics Committee in Australia. On the right-hand side, you can see images. This is a patient with metastatic advanced renal cell carcinoma. On the top, you can see the initial images that have been performed with zirconium level girentuximab scan. You can see intense activity in the sacrum where there was a metastatic lesion. And after 3 cycles of therapy with lutetium girentuximab, you can see on the bottom row that the amount of activity in the sacral lesion has significantly decreased, again, giving us confidence that the injected therapy has made its way to the bone lesion. Now if we consider the life cycle of girentuximab compound, let's have a look to the TLX252, our CA9-targeting alpha therapy for pan-tumor approach, including ccRCC. When patients have high expression of CA9, they often face resistance to chemotherapy, immunotherapy and with time also radiotherapy. We think this is a good target for radioligand therapy because with an alpha isotope, we can use the increased activity directly targeting the tumor cells. We have submitted to the Human Research Ethics Committee application in Australia in late Q2 and look forward to start our Phase I trial once we receive ethics approval. Let's move to the next slide and moving to the neuro-oncology portfolio. I will start with the good news of receiving full ethics approval in Australia to start the IPAX-BrIGHT. IPAX-BrIGHT is a pivotal registration-enabling study in recurrent glioblastoma. Given the absence of effective options for glioblastoma, we are very pleased that this agent has been granted an Orphan Drug designation, both in U.S. and Europe for treatment of glioma. Our initial focus with PDX101 is going to be in glioblastoma, the most common and aggressive form of primary brain cancer. There is no established second-line treatment at this point. And if we look at the NCCN guidelines in U.S., it tells you that the clinical trial [indiscernible] is option for treating second-line patients with recurrent disease. Also, I just wanted to summarize data that we disclosed previously this year. IPAX-1 and IPAX-Linz in the recurrent setting demonstrated an acceptable safety profile as well as encouraging overall survival duration, both from the time of recurrent diagnosis ranging from 12 to 13 months and time from initiation of treatment from 23 to 32 months. It's a great achievement when we know the average life expectation, which is extremely reduced in this debilitating disease. On the right part of the slide, you can see a patient case coming from a compassionate use program in Europe. In this patient, the scans describe a stable disease for 18 months, very encouraging when you know the severity of this disease. Turning to our targeted alpha therapy approach in neuro-oncology, utilizing astatine isotope. We believe patients with smaller, more diffuse disease may be well suited with the mechanism of action and the higher energy deposition of astatine-211. We are currently in the process of preparing regulatory filing for submission for leptomeningeal disease and conducting a collaborative initiated -- investigator-initiated trial in glioblastoma. Let's move to the next slide, please. And focusing on the other solid tumors and hematology disease. Let's start with the TLX400, our FAPi, which stands for fibroblast activation protein inhibitor, an antigen expressed on the tumor microenvironment. The diagnostic piece has been confirmed in patients and we have several publications on the topic. We are looking forward to bringing this molecule to the clinic. The Phase I pan-cancer Basket study starting -- will start in 2026. The other 2 molecules we have are TLX300 in licenses from Lilly, PDGFR alpha for advanced metastatic soft tissue sarcoma. We have initiated a Phase I ZOLAR imaging trial that is recruiting patients in New Zealand and Australia. We also have the TLX66 for bone marrow conditioning for allogeneic stem cell transplantation, more specifically in myelodysplastic syndrome and acute myeloid leukemia. Let's move to the next slide. In conclusion, it is an extremely busy first part of the year. Telix has one of the most complete therapeutic portfolio with 10 pipeline assets and even a few more if I add some the research stage with ImaginAb recent acquisition. Within urology and neuro-oncology, we are progressing, initiating 3 pivotal trials. First, advancing the pivotal trial with ProstACT GLOBAL; second, preparing the pivotal trial LUTEON for the 250 compound and starting the pivotal trial IPAX-BrIGHT. We are also starting the clinical trial with the TLX090, which is the perfect companion product for our ProstACT portfolio. And I don't forget that we are entering first-in-human trials with our 2 alpha emitters, TLX592 and TLX252. Thank you for your attention.

Thanks very much, Richard. Great rundown and really conveys the depth of the pipeline and development activity and progress over the last 6 months. So as is typical, I get to end the presentation with a summary of our upcoming catalysts and key objectives. This is by no means an exhaustive list but captures some of the key value creation events that are on the near-term horizon. Many of these catalysts are new commercial opportunities that will add to our revenue and earnings growth and will support our expansion and transition into a fully-fledged theranostics company. Some of these catalysts relate to new clinical data points that I believe will reinforce our leadership position as an innovative player in the radiopharma space with pipeline of either best-in-class or first-in-class assets. Expanding our capabilities is a key driver of near-term value creation as we work to deliver our products into major global markets. Our investments are focused on building the operational strength needed to unlock these markets and then, of course, to scale sustainably. In closing, Telix continues to demonstrate strong growth and operational improvement. We've never been more focused or committed to delivering value for our shareholders, our clinical partners and most importantly, the patients we serve. Thank you for your attention. I hope you found this presentation interesting and informative, and I now open it up for questions.

[Operator Instructions] Today's first question comes from David Low with JPMorgan.

If we could start with just the outlook for gross margins. I mean I think it was very useful to get all the update on RMS (sic) [ RLS ] and understand exactly where the contribution is, but I heard the message that you think it can improve. And then, of course, we've seen some fairly significant changes in PSMA pricing in the last quarter, particularly the back end. I'm just wondering how that's going to play out and of course, trying to understand how Gozellix fits into that mix as well. So if I could have someone have a go at answering some of those facets, please.

Well, Darren, why don't you -- it sounds like 3 questions, not one, but why don't you go ahead, Darren, and start off with the gross margin.

Yes, sure. Thanks, David. Obviously, this half year has been quite a change for the organization where we've compared to the prior year where we're only selling Illuccix. And I think the first key point is that the Illuccix gross margin is -- and you can see this by looking at that precision medicine slide has remained fairly consistent. I think we reported 65% last year and 64% this year. So obviously, no real change in the gross margin perspective for Illuccix in the market from the gross margin. Then when we look at RLS, we see there the addition of those third-party products and also the kind of internal contribution that it received by selling our Illuccix product into the market that they're able to achieve a 7% gross margin once you've included the radiopharmaceutical -- sorry, the radiopharmacy cost into the cost of goods. The interesting thing we have done a little bit of benchmarking and what we found is the industry that's similar, some of our partners/ competitors are doing a very similar gross margin in that kind of low to mid-range single-digit yield. So gross margin is obviously a result of those 2 businesses brought together. So the 53% is the average based on the load of business. I think the important thing to remember, though, with RLS is that as we start to push a product like Illuccix and the higher contribution that it provides to the RLS business that, that should help grow the dollar gross margin for that business with little or minimal cost impact on being able to deliver that to patients. So what we would potentially see is as we add the more Illuccix and potentially the future products that we're looking to bring to market in Gozellix, Pixclara and Zircaix, that will continue to assist that business to make a better contribution to the organization. Hopefully, that kind of answers your question, David.

Yes. I think I don't have anything to add except for that, obviously, we didn't acquire RLS for its commodity radiopharmaceutical business. We acquired it to put a larger proportion of our own products through and to prepare for when we have to distribute therapeutic unit doses, which you can't do that without a nuclear pharmacy dose dispensing. If you want to deliver a prefilled syringe to a customer, which is the name of the game, you got to have a pharmacy network to do that. So this is not about like what's going to happen this quarter. It is what's going to happen in the next quarter and the quarter after that and 3 years from now. So let's move on to the next question.

The next question comes from Tara Bancroft with TD Cowen.

This is Nick on for Tara. I have one on the guidance and the continued growth of Illuccix moving forward. So to reach the 2025 guidance with assuming stable RLS revenue, obviously, it's a little bit difficult to say that right now. But it appears like Illuccix sales growth may be slowing a little bit. Is this due to the loss of pass-through status? And what impact could this have on Illuccix net sales? Also, could Gozellix need to return to growth once it does have pass-through status?

Yes. I mean, obviously, we give guidance on an annualized basis, not on a quarter-by-quarter blow. So you're absolutely correct. 1st of July, we came off pass-through. We actually reported 7% growth quarter-on-quarter, which is, I think, exceptional -- 7% growth in volume quarter-on-quarter, which is really exceptional performance if you -- particularly if you take some of our competitors' financial results into consideration. So what we did is we made a decision that we were going to stabilize our customer book going into the third quarter. We have the situation where we have one product coming off pass-through and then another product getting reimbursement effective 1st of October. And we've got to bridge that gap and we chose to take certain commercial actions to do that. And we still had growth in revenue quarter-on-quarter, again, where our competition didn't. And so I think we have a nice stabilization strategy for Q3 and then Q4 continues with the advantage that we uniquely have of a second product introduction. I don't know, Kevin, if you want to add anything to that?

I would just add that we just continue to take the market pragmatically and continue to sell clinically on our accuracy as we spoke of earlier in my presentation and then continue to drive that message with reliability. And again, we have a strategic pillar and our customer-facing team that really represents well and is able to really manage that ASP and volume mix that we work on with that piece of the business and the strategic accounts.

Yes. And I think you'd be mistaken in thinking that this is just a pricing game. It's not. I think there's 4 pieces to commercial success in the market dynamic today, as Kevin said, selling on clinical value proposition, which we have demonstrably the strongest clinical value proposition. It's selling on service and service quality. Then there is, of course, pricing and pricing structure, particularly for large volume customers. Unlike our competition, we don't throw it all at the same price to everybody. We give benefits to our customers that are more loyal than smaller customers. And I think the last thing is clearly reimbursement status. And again, to reiterate, we go into Q4 with a very strong and differentiated commercial strategy with Gozellix. And we're excited about that. We're looking forward to it. Sales team is pumped.

Our next question comes from David Dai with UBS.

Congrats on the quarter. I'm just curious about the Zircaix launch readiness. Maybe you can highlight some of the things you've been doing for Zircaix and how should we think about the launch in the first and the second quarter after approval on August 27?

There's probably not too much to really kind of openly discuss. I mean the commercial team, it's not their first rodeo. We're selling into the same customer base, same referral physician base as Illuccix. So it's a very straightforward pathway to the customer. We're clearly focused on using our Illuccix customer base to seed that product launch. And I would say commercial team is ready to rock and roll on Zircaix. I don't know if you want to add anything to that, Kev?

No, I think the combination of a urological call point with a nuclear med physician base that's reading that is really the key to success there. And we've had an expanded access program going for a while that's demonstrated exactly what we saw in the ZIRCON study. So we're excited about the launch and just haven't given guidance for 2026 yet.

Yes. I mean we've had a lot -- the expanded access program, the EAP has been a huge success. We've done a very, I think, well- orchestrated unbranded physician education campaign. So as far as we're concerned, the market is ready for this product.

The next question is from Andy Hsieh with William Blair.

Congratulations on the performance. So for the BiPASS study, obviously, very provocative in terms of the disruptive potential. I'm curious, the trial is posted on ClinicalTrials.gov. You have some primary endpoints. Just curious about some secondary endpoints that you're contemplating on and how you think about some of the outcomes, longer-term outcomes for patients pertaining to survival or treatment steps that you can really, really convey the value of taking this agent upfront?

Yes. So this study was really born out of and driven by KOL engagement around where is PSMA going to really go as we move up the treatment cascade. And to be quite honest with you, on the front line of patient management, not a lot has really changed in the last sort of 15 years. It's pretty archaic. And whilst MRI, of course, gets better and better, we're still doing well over 1 million biopsies a year and a good proportion of those biopsies aren't adding any value to the patient journey. So just to be clear, our goal is not to eliminate biopsy. I mean that's a nonsensical clinical objective. A biopsy is super important. What our goal is, is to make biopsy count and to use it where it's absolutely essential and to use the scope of biopsy where it absolutely makes sense to do that. In terms of the -- we will, of course, be putting out the trial design on ClinicalTrials.gov. It's only just -- that study is just launching. So clearly, we want everybody to understand the endpoints. But to the implied part of your question, yes, there will be a monitoring period. It won't be a very long monitoring period, but there's definitely a follow-up period that's part of the evaluation of the utility of prostate imaging in that patient segment. So stay tuned, Andy, we've got more updates on that trial design coming down the pathway.

The next question comes from David Nierengarten with Wedbush Securities.

I just had one on the ProstACT study. Just around the parameters, you've recruited the patients. Kind of what are you looking for on the dosimetry and safety side? And when you think about the movement into the Part 2 of the study, is it still the plan to carry forward all 3 combinations? Or could that change in the future when you talk about the results from these first 30 patients?

Well, things can always change based on data. But we -- at present, our plan remains as stated. The real purpose of the Part 1 study and frankly, the reason why it took a while to accrue is because it's a multi-time point specto dosimetry, a lot of patient visits involved, typically requires specialist centers. So it's really a subset of departments that are really suitable for running that study. And it is, as I said, it's a demanding study on patients. We know that when we move into the second part of the study, which in some countries is a seamless transition. So that's already in play. It's a very straightforward transition and a much more straightforward study protocol from a patient perspective. And the 3 different arms were because we had the aspiration in this study to have flexibility on the choice of RP. We think that, that's an important thing. And so really, what we're looking to get out of Part 1 is confirmation of our understanding of the safety profile in combination with both RPs, different RPs and Taxanes. We fully expect that, that's what's going to progress into the second part of the study. We think that there's a compelling clinical use case for all 3 of those combos and our mission is to really demonstrate to the agency that, that safety profile is consistent across -- really across different RPs. So I hope that answers your question, but we're really excited to have that first run-in part done. It was a pretty painful study protocol. The rest of the study now is going to pick up at a much greater pace.

The next question comes from John Hester with Bell Potter.

I want to just come back to the situation with PSMA pricing. I'm sure everyone on the call heard the comments from Lantheus a few weeks ago regarding the competitive situation and also Kevin referred to competitive pricing pressures in the market in his prepared comments. So the question is this, are you worried about that pricing pressure contagion spreading to your own market? And can you also sort of update perhaps on what you've seen on those pricing pressures in this current quarter?

Well, I think we've reported all the numbers. So the numbers are the numbers. I think that pricing is a direct function of both competitive dynamics and clearly, reimbursement status. The market is complicated. As you know, there are multiple customer segments in the market that have different competitive dynamics and different pricing dynamics. What we do know is that customers prefer understandably to use a reimbursed product. Lantheus came off reimbursement, and that certainly puts pressure on their business. We've now come off reimbursement, albeit for a very transient period of time because we have been granted a HCPCS code for our life cycle management product. which, by the way, has innovative aspects in its own right. Like it's not just a direct follow-on. There's some genuine clinical and clinical workflow benefits that comes from that product. So the way that we manage pricing and pricing consistency is by ongoing innovation and capability delivery to our customers and differentiating ourselves in that -- in both the clinical use case for the product and the reimbursement profile of the product. And so -- and I don't want to sound facetious, but no, pricing pressure is not what we worry about because we have a life cycle management strategy to address it.

Today's last question will come from Andy Hsieh with William Blair.

So Chris, I'm just curious if you can comment a little bit more about the aluminum fluorine technology that you mentioned that kind of allows you to traverse between the gallium-68 and fluorine-18 isotopes. Can you speak to maybe the commercial implication, i.e., what is the next steps in terms of potential regulatory pathway and then supply chain, how does that kind of fit into your goal of being a vertically integrated company, leveraging the RLS and ARTMS platforms?

Well, on the node, so I'll start off with the science lesson, and then I'll hand it over to Kevin to talk about the commercial implications and the physician preference. But essentially, when you react aluminum and fluorine together, it's pretty violent coupling. And what you end up with is a metallized version of F-18. And it turns out that, that metallized version of F-18 is a drop-in replacement for gallium. So what it means is that you have the same targeting agent with the same chelator and you can interchangeably substitute either gallium or F-18. And the beautiful thing about aluminum fluoride is that you make it in extremely large quantities at a cyclotron facility. It's not a drug per se. It's essentially an API, a hot API. And you can drop that activity then into nuclear pharmacy and using all of the benefits and the production workflow advantages that we have of the kit-based approach we can essentially, particularly in high-density areas or where we want to service large academic customers that really are enamored by F-18, and I'll get Kevin to characterize the customer base a bit more, but it enables us to seamlessly transition between gallium and F-18 and of course, continue that life cycle management. And PSMA-11is really well demonstrated in terms of its sensitivity and specificity as a targeting agent. And now we get to marry that kind of superior pharmacology of PSMA-11 with the utility of F-18. And still, by the way, utilizing our well-trodden and well- understood distribution model. Maybe, Kevin, you want to comment on physician preference?

Sure. So as you know, we launched Illuccix 3 years ago and we've successfully taken over 1/3 of the market, pushing 40% of the market with gallium. And we believe that gallium is a fantastic product and we're going to continue to execute on our Illuccix and our Gozellix plan through the marketplace. But what we do see is some stalwarts that have used F-18 for many other products through the years and tend to favor that more. The reality is that we believe our reliability story, along with our commercial customer-facing team can support that in the next couple of years as we move from -- in our life cycle management from Gozellix and continue to maximize gallium cells and then find, if you will, the corners of the canvas, if you will, to paint with AlF, and we believe that's a great product to do it through our distribution and commercial network.

Yes. So maybe just to wrap up because it's a super great question. And by the way, you're the first analyst that's ever asked a question about it. So that's why I'm grateful to elaborate a bit more. But going forward, I think what you're going to really see is we have a whole pile of imaging products coming down the pike, including, for example, there's a gallium FAP agent there. As we develop that agent, we'll think about how this time do we avoid having to participate in a physician preference discussion, right? Some folks like gallium, some folks like F-18. Some guys drive the beamer, some guys drive the Mercedes. And we're going to set up shops so we can make both available depending on what the preference is. All right. Well, look, I think Yes, I think we're at the end of time anyway. Well, thanks -- I just want to say thanks very much to everybody for your time today and I appreciate the opportunity to give you an update. Thanks very much.

That does conclude our conference for today. Thank you for participating. You may now disconnect your lines.

Thank you for standing by, and welcome to the Telix Pharmaceuticals Limited FY 2024 Results Call. All participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to Ms. Kyahn Williamson, SVP of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Ashley, and thank you, everybody, for joining us morning Australian time. We're pleased to share with you our full year results for 2024, which we lodged with the ASX yesterday afternoon Australian time after market close, just looking through our standard disclaimer. I am joined today by Chris Behrenbruch, our Managing Director and Group CEO; Darren Smith, our Group CFO; Kevin Richardson, our CEO of the Telix Precision Medicine business; and Richard Valeix, the CEO of Telix Therapeutics. Together we will be taking you through our performance, financial results and focus for 2025. If we could move to Slide 5, please. Just by way of some introductory remarks, 2024 has once again been an extraordinary year for Telix. We are delivering against all aspects of our growth strategy and some of these operational highlights include the continued strong commercial performance driven by sales of Illuccix and the creation of a platform for further growth as we prepare to launch three new products in the U.S. next year and roll out Illuccix globally into Europe and UK specifically. We're making great progress across our therapeutic pipeline, notably in the late-stage assets being brain, kidney and, of course, our prostate cancer program which is now in Phase 3. And we've had some really exciting developments across the next generation pipeline including delivery of a clinical proof-of-concept for our prostate cancer alpha candidate. It's been a year of many acquisitions and these are supporting the strategic expansion of our pipeline and the build out of our global product delivery or manufacturing infrastructure. So in short, the business looks very different to what it did a year ago and at the end of 2025 it will look very different again as a result of this great progress. If we could move to Slide 6, please. This is also reflected in the financial performance, which Darren will take you through today. Our commercial performance has underpinned delivery of our second consecutive year of profit and growth in a year that saw us increase our investment in R&D and this which we expect will translate into near-term value creation for shareholders and strategic transactions that have assisted in the transformation of Telix and set us up for ongoing leadership in this rapidly growing market. Today's presentation outlines these key developments and the step change in our operations as a result of the acquisitions we've made. With that, I'd like to hand over to Chris to talk further about the strategy and our performance over the past year.

Thanks very much Ky and good morning everybody and we could move to Slide 8 please. Although Ky has somewhat introduced the strategy outline in a prior slide, this is a nutshell summary of how we see the Telix growth strategy over the next three to five years or so. It's focused on four priority areas of business activity. Firstly, our R&D investment, which will be well covered in this presentation both financially and operationally. It's really about delivering long-term shareholder value and patient outcomes through our therapeutics pipeline. At the end of the day, that's what the core mission of Telix is and as I'll show you in a minute, represents a step change for the company when we achieve it. Richard Valeix, who leads this business unit, will go through the details shortly. Within this effort, we are building the strongest portfolio in the industry of next generation radiopharma products with a focus on novel targets and alpha-emitting radionuclides. We've made several transactions and licensing deals that support this and in some respects it represents a pivot towards a more internally sourced innovation model and this is reflected in our R&D growth. The engine room of the business today is our precision medicine business led by Kevin Richardson, which encompasses our diagnostic imaging products but also has the mandate to ensure that we have well thought out patient selection strategies for our therapeutics program and strategically designed clinical trials that have a high degree of certainty of success because we're utilizing the whole theranostic power radiopharma. That's why we call that business unit precision medicine and not diagnostic Imaging. And lastly infrastructure. This has been a big focus for Telix over the last couple of years with some significant investments such as our state-of-the-art European manufacturing footprint in Belgium and the acquisition of ARTMS and RLS among others. We have also been steadily adding important R&D infrastructure that really enables the other pieces of the strategy puddle. We move to Slide 9, please. Our M&A activity maps very well onto this strategy and while I'm not going to go through this diagram deal by deal, you can read about that in our annual report. Our M&A supports our strategy through building the fundamental delivery vehicles of our business, new platform technologies and the expansion of our product pipeline. This pipeline expansion consists of both new molecules, but also other relevant assets that enable us to obtain new indications or clinical use cases for our products such as software, AI and medical devices. Nuclear medicine is a bit unique like that. As you can see last year we really enriched the scope of our business activities while remaining pretty disciplined around the disease focused areas that we think are going to be the most important for the future. We've been busy. Slide 10 please. So clearly a strategy is not temporally static and with specific reference to our 2024 financial results, I'd like to impress upon you that we are moving into next epoch of the company's growth and development, empowered by both our M&A activity and our product development success. Since becoming a commercial stage biopharma company in 2021, we've ramped up quickly to build all the key components of a commercialization company in key markets. The remarkable success of Illuccix, particularly in the U.S., has really enabled this transformation from the typically hypothetical and aspirational baby biotech to a fully fledged commercial organization. As we roll into 2025, this is essentially a new phase in the company's journey. We transitioned from a single product, mostly a single market company, to a diversified product company. This year we will, subject to regulatory approvals, launch three new and innovative products in the United States for a total of five approved products in the U.S. and Europe. We will add about 20 commercial territories to our international coverage. It's a big diversification of our revenues and we expect to see commensurate growth in our top line. We have given guidance for financial year 2025, well north of a billion dollars , but this figure excludes our new product launches in territories that have not yet received national approvals. So you have to put that forecast into perspective. This exciting product revenue growth in turn enables us to largely self-finance the major R&D activity required to achieve that next inflection point, which is becoming a therapeutics company. This is not far away. Our pre-commercial launch year as a therapeutics company is 2027. That is now less than two years away. So between now and the end of 2027, our goal is to put as much firepower as possible into our R&D activity and of course, the delivery capabilities in the key markets we serve. That’s why we’ve been investing so heavily in infrastructure. To be clear, our R&D spend will grow commensurately with our revenue in the next few years. All of our R&D spend is discretionary and so we can essentially achieve whatever level of earnings we wish. But clearly the priority is to go hard and to unlock the value of the pipeline. And we’re going to maximally invest to achieve this goal, while of course maintaining sensible cash reserves and financial optionality. But from the end of 2027, as this diagram shows, things change. That’s when we’ll expect to see a step change in our profitability and for cash generation to start to really exceed our immediate planned R&D needs. I’m sure Richard and Kevin, whom you’ll hear from in a minute, will continue to find exciting things to invest in. Radiopharma is such a nascent opportunity and it’s got a very bright future, but it is the transition point where things will start to accelerate financially. Anyone hanging out for a Telix dividend will need to wait until at least then. So frankly, the day that we start paying dividends will be the day that we signal to the market that we have run out of ideas to build shareholder value. There’s so much opportunity to invest in this field and so many problems to solve in oncology. So I hope this perspective, it’s a little bit of a different diagram, we haven’t really talked about the company in this way before, but I hope this perspective is useful. I’d like to now hand over to Darren Smith, our Group CFO, to explain how, as we launch into this next phase of the company’s growth, how the numbers stack up. 2024 was a really great year and he has a lot to talk about. So, Darren, over to you.

Thanks Chris. And hello everyone. Today it gives me great pleasure to talk to Telix strong financial achievements and progress during 2024. So let’s now turn to Slide 12 and Telix’s key financial metrics. It’s been an excellent year for Telix with all six of these metrics improving dramatically compared to the prior year. Just listen to the headline numbers. Revenue improved 56%, beating guidance; adjusted EBITDA improved 70% to $99 million; operating cash inflow improved 80%; profit after tax improved 860% and the end of year cash position finished at a solid $710 million on the back of a convertible bond placement. I will now go into some detail on these metrics on the following slides. But now let’s turn to Slide 13 and review the Group’s operating profit. As can be seen in this simplified P&L on the slide, operating profit and similar metrics all improved significantly year-on-year. The headline drivers of the results were firstly, that we achieved excellent commercial growth by Illuccix in the U.S. accounting for 97% of our revenue. Kevin Richardson, our CEO of Precision Medicine, will talk later in the presentation on how this has been achieved. Secondly, we improved gross margin through efficiencies and stable pricing across key market segments. And thirdly, we are effectively managing expenditure as a percentage of revenue. Now turning to Slide 14 in the Group’s adjusted EBITDA. As can be seen on the bubble on the right side of the slide, the adjusted EBITDA improved 70% on the prior year and this is a testament to the strong underlying performance of the Telix business model. The graph on the slide shows the bridge from operating profit to the $99 million adjusted EBITDA, highlighting the impact of the main non-reoccurring corporate initiatives that is impacting operated profit in 2024. These can be classified into two main categories. There is $9 million associated with the listing on the NASDAQ and $8 million associated with Telix strategic M&A activities. Now let’s turn to Slide 15 and an overview of our research and development investment. In line with guidance, we invested $195 million into R&D, as it continues to be a key component of our growth strategy. It is growing our industry leading precision medicine business with R&D focused on the regulatory filings for Pixclara, Zircaix and Gozellix and the scale up of inventory in preparation for the commercial launches. This accounted for approximately half of the investment in 2024 with these assets expected to generate revenue in 2025. It also is delivering our therapeutic pipeline as we build momentum in our Tx clinical activity. The R&D investment is increasing and it is concentrated on progressing our late-stage assets for prostate, kidney and brain cancer therapies. Now let’s turn to Slide 16. Our Precision Medicine business is currently the commercial engine house of Telix, focused on growing our industry leading precision medicine products. As noted already it delivered revenue growth of 55% for sales of Illuccix. Gross margin improved 3% to 65%, reflecting a higher realized average price due to improved market mix and steady [indiscernible] goods. And we also continued to invest into selling and marketing to drive further growth of Illuccix in the U.S. and launch in Europe in 2025. We are also progressing the U.S. market for the launch of three new imaging agents. As a result, the Precision Medicine business grew its adjusted EBITDA by 79%. This funded not only its own R&D but also the rest of the business. Now let’s turn to Slide 17 in our therapeutic business segment. This segment of Telix is focused on delivering our late-stage therapeutic pipeline and building the clinical products and services of the future, leveraging our research platform to develop the next generation of radiopharmaceuticals. During 2024, Telix increased its investment by 74% into the therapeutic pipeline to $82 million and over time, this is becoming a larger proportion of our R&D investment. The majority of the investment in 2024 was focused on commencing the Phase 3 ProstACT GLOBAL clinical trial including production of clinical doses to support the ramp up of recruitment. Richard Valeix, our CEO of Therapeutics, will shortly present the details regarding progress in our 2025 plans for our therapeutic pipeline. Now let's turn to Slide 18 and Telix’s manufacturing solutions. Operations scaled up this year as a result of the acquisition of ARTMS and IsoTherapeutics Group, as well as the expansion of our facility in Brussels South. This site expansion included the installation of two new cyclotrons in the preparation of commencement of GMP production in 2025. The expansion of operations has resulted in an incremental increase of $19 million in operating expenses for TMS. This will continue to evolve as in January, we completed the acquisition of RLS which included the footprint of 31 pharmacies across the United States. The results of RLS, which is immediately accretive, will be included in the TMS results from 2025 onwards. Now let's turn to my last Slide 19 which highlights the cash position and performance. Telix finished the year with a very respectable $710 million on the balance sheet, mainly bolstered by the $650 million convertible bond placement that we undertook in July 24. This enabled us to continue to pursue our strategic M&A opportunities such as the RLS acquisition, as well as providing the resources to provide further acceleration to the investment in our late-stage clinical programs. Net cash used in investing activities in 2024 totaled $135 million. This included $31 million in expanding our global production infrastructure, $20 million to expand our portfolio of intangible assets, $14 million for risk mitigation by the strategic acquisition of crucial raw materials, and $50 million was placed in a security deposit. Turning to operating cash as previously discussed, Telix invested $195 million of its operating cash into R&D for our therapeutics and precision medicine business, plus funded the $36 million contingent consideration payment to our former ANMI’s shareholders. After netting off these payments, Telix still improved its net operating cash flow over the last year by 80% to $43 million. This clearly illustrates the sustainability of the Telix business. I'll now hand you over to Kevin Richardson, our CEO of Precision Medicine.

Thank you, Darren. Slide 21 please. To help define the precision medicine business, please see the slide on our expanding commercial portfolio. We will go over in more detail our prostate imaging asset as well as our kidney and brain over the next few slides. But I did want to make note of a recent announcement that we intend to bring into our precision medicine business unit and further develop Scintimun as a companion patient selection and safety assessment tool for TLX66, its therapeutic bone marrow conditioning candidate. The plan is to increase sales for its current indication by improving product availability worldwide with commercial consistency. Slide 22, Telix continues to strengthen its position in the PSMA market with Illuccix, our first commercial product, driving revenue growth for the 10th consecutive quarter since launching in April of 2022. Q4 2024 saw a 55% increase over Q4 2023 while achieving over $500 million in U.S. sales for full year 2024 reflecting our strong market momentum. Our commitment to clinical accuracy, reliable delivery and exceptional customer service attracts and retains our customers. What we mean by that is that our Illuccix product has the highest interrater agreement of the currently marketed PSMAs delivering an accurate diagnosis, while our 245 points of distribution puts our PSMA within minutes of our customer at dispensing. We are your friendly neighborhood pharmacy. We like to say it's locally farmed to scanner and our customers say that our multifunctional approach to the customer experience let the customer hit the Telix easy button when they begin using our products. Our performance is driven by executing our commercial strategy with consistency, expanding our market reach and capturing more share. With CMS reform providing a tailwind, Illuccix retains pass through status through June 30, 2025 with CMS reform as a backdrop in the impending launch of Gozellix. We look ahead to our two product strategy as Telix establishes itself as a leader in prostate cancer imaging, enabling continued innovation and reimbursement for new products in the years to come. Slide 23, global expansion of Telix's industry leading precision medicine portfolio is a key driver of our growth strategy. In the U.S. our commercial portfolio will continue to expand with the launches of our urology products Gozellix and Zircaix, followed by Pixclara for our neuro franchise. Gozellix is an innovative new PSMA candidate that is designed to increase availability and efficiencies in large urban areas and extend our product reach to distant PET/CT scanners that are in areas where patients can't access PSMA because they are out of reach for current technologies. Once approved, we expect to apply for transitional pass through payment with the Centers for Medicare and Medicaid Services. Once approved, Telix will be the only company with two PSMA agents in the market allowing us to satisfy the needs of both HOPPS, accounts and non- HOPPS accounts. Zircaix is our first-in-class renal imaging agent designed to diagnose patients with ccRCC with undiagnosed renal masses. This is a new diagnostic area for PET imaging and Telix will leverage our success with the urologic physician and imaging centers who have growing confidence in PSMA imaging. Finally, our Pixclara agent will bring to neurology customers a technology that will quickly identify treatment related inflammation from tumor progression or pseudo progression and determine the best treatment pathway for the patient. Looking ahead towards our precision medicine pipeline, we will drive sustained growth through active product lifecycle management and introduce novel products that align with our therapeutic focus. We plan to expand patient reach through label expansion, advancing studies in prostate, kidney and brain with a particular focus on metastatic disease for our kidney and brain products. Our global growth strategy includes expanding our footprint across Europe and the UK while simultaneously preparing for regulatory pathways into China and Japan in the Asia-Pacific region. These efforts will ensure broader access to our precision medicine solutions, reinforcing Telix’s leadership in targeted medicines worldwide. We plan to leverage our commercial success in the U.S. across products, indications and geographies, protecting and growing our share through strategic account management and a two product PSMA strategy, strengthening our relationships with leading cancer institutions worldwide. You may note our recent announcement on our AI partnership that is designed to bring technology together with the Illuccix or Gozellix to increase patient throughput in an imaging center allowing them to treat more patients and reduce the wait time to get this life saving PSMA scan. Utilizing the success, we’ve experienced in the U.S. we plan to take that commercial playbook and strengthen the global brand into new markets around the globe. Slide 24, please. Turning towards 2025, we’ve already talked about the potential to launch three new products this year, which are subject to regulatory approval. Our launch planning is well underway. We built out the commercial infrastructure, we trained our customer facing teams and we’re currently delivering disease awareness education to the customer base through multiple channels. This investment is reflected in the financial results. Gozellix our second PSMA agent has a PDUFA goal date of March 24, 2025 and is a key for Telix and rounds out our two product strategy in the U.S. The global expansion of Illuccix is a priority for Telix, following the positive opinion from the German regulatory body, we are set to launch in 19 countries including the UK. As approvals are finalized, we will begin implementing our country commercialization plans beginning in the first half of 2025. Additionally, we are nearing the completion of China Phase 3 bridging study as we progress our Asia-Pacific rollout strategy. In the U.S., Zircaix has filed a BLA in December of 2024 and we are expecting a PDUFA date after the U.S. summer in 2025. With an expanded access program already in place across the U.S. and globally, physicians are already using our innovative kidney agent around the world on their patients and it is included in the EAU guidelines as an emerging technology. Moving to our neurology platform, Pixclara has an NDA with a PDUFA date of April 26, 2025, also with an ongoing expanded access program in the U.S. Our neurology franchise will target global regulatory filings based on market opportunities as we go – as we gain momentum around the globe. All the hard work our teams put in, in 2024 has set 2025 to be an exciting year as we transition to a multi-product multi-national commercial company, diversifying our revenue streams through multiple products across geographies. Thank you. On to Richard Valeix, CEO of Therapeutics.

Thank you, Kevin. Hello, I’m pleased to be able to speak to you today about the strategy of Telix Therapeutics business. Telix has built a pipeline of highly differentiated therapeutic candidates based on validated targets and clinical data. Our focus is twofold. First, in the short-term, our priority is on the delivery of three main late-stages assets for prostate, kidney and brain cancer. Our lead asset TLX591 is already in Phase 3 and our goal this year is to advance the kidney and brain cancer therapies to pivotal trials. I will talk more to that shortly. The second part of our strategy is building our pipeline of next generation assets. Telix has one of the deepest alpha pipeline in the industry. Now we are transitioning these programs which have been stage gated through our internal R&D and based on excellent preclinical data into clinic. The TLX592 and TLX102 compounds are the natural evolutions of our portfolio lifecycle management with alpha radioisotopes in order to extend indication. While TLX090, the bone seeking assets we acquired last year from QSAM is being developed initially for treatment of pain from bone metastases, that gives us the potential to treat prostate cancer patients right across their disease journey. This is also building on our strong urology footprint established with precision medicine. Finally, we have a unique opportunity to explore multi-indication or pan-cancer asset strategy. Let me explain. The CA-NINE and FAP are both validated as pan-tumor targets. Pursuing this strategy can add value to these assets, generating first-in-human data in multiple indications in a limited time frame. Next slide, please. In the next two slides, you can see our pipeline. The first slide is presenting our late-stage assets with our pivotal trial ProstACT GLOBAL that supports TLX591 compound data generation and our two additional late-stage compounds TLX250 and TLX101 that will move in pivotal trials by end of the year 2025. Next slide, please. The second pipeline slide illustrates the early stage compounds that will enter in clinics mainly first-in-human with several of these being alpha therapies. Next slide please. Moving to TLX591, our lead therapeutic candidate. It is a highly differentiated asset. It's an antibody versus the classical peptide PSMA available. It's a big opportunity. Key to the differentiation is the strategy or side effect profile and the short dosing regimen. Indeed, when you have the privilege to meet patients who have been treated with Telix therapy either on a clinical trial or via some compassionate access program, they will often mention that they have experienced very little in the way of side effects. We can deliver this therapy as a short two week course. This is appealing to patients and physicians and may enable TLX591 to be more easily added to existing standard of care hormone therapy regimens. During 2025 – 2024, we released data from our study ProstACT SELECT, which reinforced the safety profile in earlier patient population. The hematology toxicity was reversible, less severe and manageable. The patient case on the right part of the slide is from the SELECT study and illustrates a stable disease with radiographic progression free survival for almost nine months in line with the positive study results. As mentioned, this asset is now being studied in the ProstACT GLOBAL Phase 3 trial. ProstACT GLOBAL is the first trial to combine the synergistic effects of PSMA radioactive antibody drug conjugate with androgen receptor pathway inhibition and the well known docetaxel. It is generating a lot of KOL interest. This study is rebooting well, including ramping up in the U.S. we are on track to deliver interim readout in H1. As a reminder, the interim readout will be focusing on the Part 1 of the study with the first 30 patients, which is looking at safety and dosimetry of TLX591 in combination with the standard of care administered in the study. Next slide please. TLX250 is our CA-NINE targeting asset being developed initially in renal cancer. This target is well validated in clear cell renal cell carcinoma with our ZIRCON study, the registrational trial for Zircaix, Phase 1 and 2 studies have demonstrated the safety profile and efficacy potential. The images on the right part of the slide represent a CCRCC patient case with PET scan before and after treatment. It clearly reinforces our confidence and interest in this compound. We have been running a number of studies concurrently on this asset, exploring it in combination with immunotherapies and DNA damage repair inhibitors in renal and other cancers. In 2025, we will advance the pivotal Phase 3 trial as a monotherapy in late stage metastatic setting, building on the early Phase 1 and 2 data. We had a pre-IND meeting this month in February with the FDA to concert on the trial design. And based on the positive feedback, we are working towards revision of an IND this year. We will continue with the combination studies. The STARLITE studies have been run as investigator led studies giving us the flexibility to explore the optimum dose sequence. STARLITE-2 is a groundbreaking study, the first time the combination of lutetium, girentuximab and nivolumab has been investigated with positive preliminary safety data presented in the recent ASCO GU conference. Finally, the STARSTRUCK study, which is ongoing is the first rock of the pan-tumor approach. The study will authorize to deliver data for several indications expressing the CA-NINE target and will generate data for the first time regarding a radioactive ADC compound and a DDRi association. Next slide please. The 101, TLX101 is our investigational therapy in brain cancer and has obtained orphan drug designation for glioblastoma. This is a severe disease with very poor survival outcomes. Published data from the IPAX-1 study in recurrent setting demonstrated promising efficacy signals with a median OS of 23 months from its initial diagnosis. We have now completed the IPAX-Linz study which is the combination of external beam radiation therapy and TLX101 at low dose. We expect data later this half. Late last year, we had another pre-IND meeting with the FDA on the pivotal trial design, we are preparing the IND submission for pivotal trial planned for the second half of this year. We all feel very driven to move this program forward. The image on the right part of the slide illustrates why. You can see a patient case from a compassionate use program in Europe presented at the EANM Congress in 2024. It presents two PET scans performed with our Pixclara product, which will be our companion diagnostic agent before and after treatment and we can clearly see the changes in tumor activity presented by the color changes. This case represents a stable disease response, an amazing compound. Next slide please. These slides summarize our next generation pipeline strategy. As mentioned previously, we are aiming to move three of our alpha assets into first in human trial in 2025, commencing with the TLX592 for prostate cancer. I noted earlier that we are adding to our urology portfolio the two recent acquisitions, TLX090 and TLX400. And finally, we are reinforcing our R&D capabilities with the recent ImaginAb platform acquisition in order to create a new portfolio of next generation diagnostic product optimized for radiopharmaceutical drug delivery. All the deliverables in 2024 were paving the way for the disruptive year 2025 for the Telix Therapeutics portfolio with three pivotal trials, multiple first in human alpha therapies and innovative pan-tumor development approach with validated targets. Thank you.

Thanks very much, Richard. Great summary. And just to reiterate, we’ll have three programs in pivotal studies by the end of this year, which I think is a really good testament to Richard’s team and the great effort that’s underpinned our R&D this year. I’m going to talk now a little bit about our manufacturing solutions activity. Darren Patti, our Chief Operating Officer is on the road at the moment, but I’m going to step in and give a little bit of an update here. If you can move to Slide 34. So this is a summary slide of really why we think this is so important. Radiopharma is about whether it’s a diagnostic or a therapeutic product is really about proximal manufacturing and just in time manufacturing. As Kevin noted for the Illuccix product, we’re distributing that product now out of about 240 points of distribution in the United States. To deliver these products globally, you need to have infrastructure to really be able to go that last mile and make the product available with a high degree of confidence for patients. We’ve been focusing on building that infrastructure, scaling it to meet the demand both today and the expected demand for our products. And this is really a two-part model for success. We are heavily dependent on key partnerships. Our goal is not to go at the task of manufacturing alone. And in almost every market we operate in, we have key supply chain, manufacturing, distribution and even sales and marketing partnerships. But we also have a certain amount of facilitative infrastructure ourselves. And the wheel diagram on the right hand side shows how the acquisitions that we’ve made over the last few years map onto that or the investments that we’ve made really map onto that activity. And this is of course a bit of a simplification of how we do radiopharmaceutical development. But you can see now we’ve got a really complete capability from early clinical development in dose production. For example, we produce most of the doses for our clinical trials internally for Phase 1 and Phase 2 trials. We’ve got an amazing radiochemistry team and bioconjugation capabilities, including GMP conjugation. We are active in isotope production, not because we want to be in the isotope business, but because we want to have the ability to innovate and generate efficiencies in the way that isotopes are produced. And then of course, with the acquisition of RLS in tandem with key commercial partners, really focus on that last mile of patient delivery. Next slide, Slide 35 please. So for the U.S. market, this is what it looks like. In the left hand map there you can see the outline of our very important and key partnerships in the United States. This is a multi-distributor model to really take advantage of all the nuances of local commercial markets in the United States. We have also built our own network of capabilities through both the acquisition of RLS and the combination of the ARTMS technology. What this means is that we can do very high production level isotope production for zirconium, gallium and other potential key radionuclides in the future and build a very efficient distribution capability out of a very small number of nuclear pharmacies. This is not to supplant our U.S. distribution model, but rather to augment it to make sure that we’ve got backup for our key partners, to make sure that we are providing radionuclide efficiencies. And in particular over the next 18 to 24 months we’ve got a big focus on how do we provide very cost effective, large scale of gallium and zirconium production to our pharmacy partners. That’s going to have a pretty big impact on our production efficiency and eventually our cost of goods as well. Next slide please. Globally, the story repeats itself. We’ve got a significant investment in infrastructure in Europe, particularly with the Brussels South or the Seneffe facility. We are also building some distribution in – on hot lab capability in Australia to support regional clinical trials. But like the U.S., we are also very much partner driven with our – for example, collaboration with China Grand Pharma for the Greater China market and also our manufacturing joint venture with R2 Pharma in Brazil. And so what you can really see is that we’re committed to that localized production in the major markets that we serve. And this is really about guaranteeing supply and patient access for our products. Of course, there’s no doubt that by achieving some degree of verticality that we also have the opportunity for margin improvement as these businesses scale. Slide 37, please. So, just to wrap up our presentation and get ready to, to go into Q&A, we put out a summary of our guidance. Our top line number is about A$1.2 billion or US$770 million to US $800 million. This is our 2025 revenue guidance. This is revenue from the sales of Illuccix and only the jurisdictions that we have a marketing authorization at this point in time. And it also includes about 11 months of RLS revenue as well. What it does not include is Gozellix, Pixclara and Zircaix. So those products have not yet achieved a marketing authorization. Once we achieve a marketing authorization, then we will update our guidance. Similarly, although we have received BfArM, which is the German regulator’s positive opinion on European approval, we have not yet received national phase approvals yet for any other countries other than Denmark. Of course they’re coming, that’s an administrative process. But we have not included European countries that have not achieved national approval in our guidance. And we will update our guidance when we achieve those, particularly for the major European markets. On the R&D side of things, we expect our R&D to increase 20% to 25% over – excuse me, over 2024 numbers. Slide 39 please. So just to wrap up. 2025 will be an incredible year for the company. And it really builds on the foundation that we’ve laid in 2024 from a delivery and commercial execution perspective. I’m particularly excited about our ex-U.S. expansion this year, but clearly our U.S. and Canadian colleagues are going to be super busy with product launches in North America and indication expansions as well. The pipeline development, as Richard has outlined is extremely expansive. We've got a lot of clinical data readouts this year, a lot of news flow to report on, so that's super exciting. And of course, the name of the game there is about demonstrating the patient benefit of our extremely deep therapeutics pipeline. And then last of all, making sure that every day when we get out of bed and assessment aspire to deliver outcomes to patients, that we do so with a high degree of confidence and capability and not just doing it in the U.S., but really expanding that capability globally. And of course, that's through partially internal investment and partially through continuing to double down and invest in our very valued commercial partnerships around the globe. And now moving to the last slide, Slide 40. I'm not going to go through the individual bubbles in here, and this is by no means exhaustive, but it does certainly highlight, with a bit of a focus on the first half of this year, the just very large number of catalysts that we are expecting clinically, commercially and in terms of the expansion of the business. So just a lot to look forward to this year and a lot of milestones to achieve for the company as we progress the business forward. With that, I will wrap up the presentation and hand it back to you, Kai.

Thank you. We will now move into question-and-answer. So Ashley, you can take questions from the phone, please.

Thank you. [Operator Instructions] Your first question comes from David Stanton with Jefferies. Please go ahead.

Good morning team and thanks very much for taking my questions. If we could start with the revenue guidance, please. You've talked to 11 months of RLS Radiopharma. I note that in 2023 when you bought it, you noted that they did $158 million worth of revenue. What should we be broad brush, what should we be thinking about revenue growth for 2025 in that division and or a number for that division, please? That's my first question.

Yes, that number we put out was all inclusive number. We obviously don't double count the Illuccix revenue in that number. Going forward and generally across the U.S. business inclusive of Illuccix and RLS, we'd be looking at high-single-digit, low-double-digit growth. And our viewpoint and we've outlined it, if you have a look at my CEO letter in the annual report, we think that this guidance is a reflection of a continuing growth in our business, continuing expansion of opportunity for PSMA, but it also considers some of the headwinds that we have this year in terms of uncertainties in the U.S. healthcare system. Obviously, we are facing a government environment perhaps with more challenging resourcing from an FDA and a CMS perspective. And so we think that that sort of guidance is a good balance of the risk and opportunities that we see in the market this year. Obviously, David, we haven't yet included substantive European revenues in that forecast. So you should think of that as a primarily a U.S. centric forecast. Is that useful?

Understood. Very useful. So on that basis then, second question, just for the market in general, would you be able to sort of help us understand what you think market growth might be for U.S. Illuccix sales in 2025? Will it slow from frankly, very good growth in 2024?

I'll start and maybe I'll ask Kevin to chime in since he's a little more call face on that. But I think we continue to see the expansion of the PSMA opportunity. It's one of those things where new indications and new opportunities still have the potential to cause step change in growth in the market. We also think that as we start to roll out Gozellix, which you have to remember, it has a PDUFA goal date next month, but that means that the CMS reimbursement will be sort of more around mid-year. So the impact of Gozellix will start to really come in the second half of the year. We see that as also expanding our reach and our percentage of the market in an accelerating fashion. So the second half of the year can certainly see good acceleration. I think one of the things that we're dealing with right now, and maybe I'll get Kevin to expand on it, is just all the changes in the reimbursement landscape have made the near-term customer interaction, it’s pretty complicated. There's a lot for customers to digest. There's obviously differing commercial behaviors in the marketplace. We have succeeded against that backdrop of very stable pricing. We've continued to take market share. So we feel that our commercial team is doing a good job. But I don't know, Kevin, if you want to add anything to that.

Yes, I would just answer specifically on the market in general and all the changes and things that are happening right now that may affect the customer that we sell to doesn't really affect the patients that we scan. So, we still see good growth in the scanning side of that and the patients that are still coming in to get scanned. The growing confidence in PSMA scans by urology physicians and really beginning – continuing to utilize it at the same rate. So we don't see that trajectory changing.

Yes, that's right.

And final one for me, thank you. That's very clear. Final one from me. In terms of the PDUFA dates, we have noted that, some other pharma companies who had a PDUFA date in February have had [ph] delayed. I note that you've got your PDUFA date, as you say, in February coming up reasonably soon for a number of different products. Given the change in regulatory environment in the U.S. what would you say, is the risk around those dates being delayed or postponed? Thank you.

So we have contemplated that risk management in our guidance and clearly that, that we haven't got Illuccix, Gozellix and Pixclara yet in our guidance for the year. So I suppose that somewhat disintermediates it. I would say without sounding overconfident about something that I don't personally control, I think that Gozellix is in fine shape to meet its goal date. We have not had any guidance from the FDA on change in PDUFA date for Pixclara. And we've had clinical site inspections and stuff like that scheduled on time. So we're feeling very good about that. We've already got clinical site inspections happening for Zircaix as well. So the FDA appears to be highly engaged. I think not all divisions of the FDA are going to be impacted equally, but there's no doubt, I would say not making a Telix specific concern, but as an industry wide phenomenon, I think there's a lot of concern about the structure and nature of the U.S. government going forward in the FDA, in CMS, in the NIH. I think it's a Richter scale shift and I think we're all dealing with what the potential consequences of that will be.

I would just add that, we continue to have good communication as of today. And as Chris mentioned, our visits are scheduled and we're moving forward in the process. So that really hasn't changed.

Yes. Thank you, David. Much appreciated.

Very clear. Thank you. I'll get back in the queue. Thank you.

Good question. Thanks.

Your next question comes from Laura Sutcliffe with UBS. Please go ahead.

Hello. Thank you for taking my questions. Could we look at Slide 10, which is like you said, a new slide, I think for us this time around. It looks as though your first therapeutic product to market will be hitting around 2028. Which of your pipeline assets do you think will make it first?

Yes, look. We haven't sort of given specific guidance on that. I mean, actually what I said was that 2027 is our pre commercial year. So what that means is that in 2027 we expect to have regulatory filings in place. I think that at the rate that we're going with ProstACT GLOBAL, I would expect in 2027 that we are having those filing discussions. Of course, subject to the clinical data being what we hope certainly based on PFS data. In 2027, we would also expect to be on the cusp of pivotal trial data readouts potentially for 101 and 250, because those two assets will go into pivotal trials this year. And we think that based on the clinical trial strategy that we have, those can be fairly streamlined trials. So I think that there's a lot of momentum in the therapeutics program in the second half of 2027 as we get ready to launch those products in 2028.

Okay. Thank you. And could I ask about the 591 interim? Obviously, you've been pretty clear that the data will be from the safety run in phase from part one. Do you expect to be able to give any insights on efficacy? Or should we purely expect safety and dosimetry data?

We spoke as an immediate effect of completing the enrollment of part one. It will be safety and dosimetry, although it will be very interesting because it will be comparative information across enzalutamide, abiraterone, and docetaxel combinations. But the intention is still to provide interim PFS data. It will be event driven, obviously. So I can't give exact guidance of when that's going to be, but there will certainly be ongoing reporting on that study as it progresses. I don't know, Richard, if you want to add anything to that.

Yes. As you said, so the primary focus will be the safety and dosimetry, which are already very interesting data for the development of this compound in association with the classical treatments. So the RPFS will come perhaps a little bit later, but we are monitoring that and we will be keen to disclose that without penalizing the clinical trial.

Yes. Thank you, Richard. What else have you got, Laura?

I'll just go with one more. For your bone palliation agents, 090, what is the pathway to approval for something like that look like? Do you need one or more full Phase 3s? How big do they need to be? And what does the FDA think is the right comparator in this situation?

Yes, we've actually had a pre-IND consultation with the FDA to talk about our current state of data. The predicate product for that is there is in fact a predicate product for that. That gives us quite a bit of guidance on how a product like that would be developed. We do have really nice data, including repeat dosing data that shows the utility – clinical utility of the product. The study that we would expect to run is not a classical therapeutic treatment response study. Our first indication is focused on pain management, and that results in a very compact trial design. So historically, and we haven't put a trial protocol in front of the FDA, we've been invited to do so. But historically, a trial like that has been in the vicinity of 150 to 200 patients, with a primary endpoint being pain scoring for a period of time, typically 12 weeks to 16 weeks of pain scoring. And that results in a very tractable trial design that can recruit and complete very quickly. So the attractiveness of that agent is really that we are doing some bridging and comparative dosimetry work right now to the predicate product. Once we have that data to present to the FDA, then we will go back with a trial design that is along the lines of what I just outlined.

Super. Thank you.

Your next question comes from Andy Hsieh with William Blair. Please go ahead.

Oh, great. Thanks for taking our questions. A couple from us if you don't mind. So, one, I want to go back to the ProstACT GLOBAL study, especially with the dosimetry portion of the interim analysis. I'm curious if you will be able to detect what Dr. Louise Emmett had shown in the ENZA-p Study where enzalutamide could upregulate PSMA expression. Just from that dose symmetry portion of your trial, as a way to kind of amplify the response? So that's question number one. Question number two has to do with the DA9 franchise. I'm curious if you could comment on the labeling efficiency of Zircaix, since you're doing – you're using a different key laser for this one. Obviously, you have gross margin implications here? And related to that also STARLITE-2 really curious about when the results will come in. So I'm just curious if you can comment on kind of the timing to what type of data in combination with nivolumab we can expect? Thank you so much.

Yes. So I think it's kind of three questions there. The first one is very straightforward. I mean, we obviously wouldn't estimate what we might see in clinical data that we haven't yet got in our hands. But you are right certainly the – part of the basis for the trial design is that there is a synergistic effect for both the RPs and in fact the taxanes, and up regulation of PSMA is one of them. Those patients are scanned serially in the study. The dosimetry is a multi-time point dosimetry study. So if there is an effect around PSMA expression levels, then we may well see it from the data. And that's exactly Richard commented and I won't ask him to repeat it, but that's why Richard commented having the comparative data between the three different standard of cares is going to be really interesting. And we'll certainly put that commentary out there when it's available. Regarding the second question, which was radio labeling efficiency, so generally, I mean, as a general statement across the antibody drug conjugates, one of the consequences of the type of chelators that we use and the radiochemistry that we use is very high radio labeling efficiency. Typically, because of the slightly higher cost of goods of a biologic compared to a small molecule, we don't have a tolerance for poor radio labeling efficiency. But typically radio labeling efficiency, we shoot for 85% to 90% radio labeling efficiency. I am bound to tell you though; it does not have a profound consequence on cost of goods. And the reason is that the production efficiency of zirconium and gallium with the ARTMS target system that we have is extremely high. We produce multi-Curie quantities of radionuclides. So, if the efficiency is plus or minus 5%, it's in the rounding noise of the economics for the product. And then the third question relates to STARLITE-2. So on the back end of ASCO, where we obviously wanted to give our KOLs the chance to have some podium and poster time, we actually will be shortly running an update on the STARSTRUCK-I, STARSTRUCK-2 sorry, STARLITE-1, STARLITE-2 and STARSTRUCK studies. So, yes, that will be the subject of some further data released quite shortly.

That's super helpful. Thank you so much and congratulations on all the progress.

Thanks. Thanks very much, Andy.

Your next question comes from Tara Bancroft with TD Cowen. Please go ahead.

Hi, good evening or I guess good morning for you. But I'm hoping you could help us better understand what the implied impact in the second half for pass through expiry is for Illuccix in your 2025 revenue guidance. So I mean, I guess specifically upon that expiry, do you have an idea of what the average MUC base pricing would be for fee for service patients based on historicals? And also how many of treated patients would this impact? Like how many now are CMS patients and specifically fee for service?

I'll start and then I'll hand over to Kevin. I mean, we don't give guidance on what we think our MUC pricing will be since that's obviously a future event that will depend on a number of other pricing parameters at the time that that comes into effect. And clearly, I think as a general statement, the HOPs [ph] impacted segment of the market is roughly half of the market. I think that's generally known, it's a similar phenomenon for [indiscernible]. So that's the impacted patient population. Although there are obviously subcategories of patients within that segment. So that's my initial sort of answer – high level even answer to your question. Kevin, if you want to chime in on add anything?

I think I would just add that that's why we have a two product strategy. The CMS pass through expiration is a known event and we plan for that known event with Gozellix launch and we're timing that up very nicely and we'll manage smoothly through that transition. So I think the larger answer to your question is based on our guidance and you'll be able to look at that and see what we're think, and what we're going to be able to do in terms of product mix. Remember, we'll be the only company out there with a two product strategy in PSMA to manage that situation.

Yes. And just to reiterate earlier that our guidance, as it stands, does not include the impact of Gozellix in the marketplace. So it's Illuccix only guidance.

Okay, got it. And so just to be clear, so your commercial strategy for Gozellix is almost that it will cannibalize the Illuccix revenue after the pass through expiry or will it also – do you plan for it to take from competitors or do you plan for it to grow the market? Maybe just a little more detail on that?

Well, I don't think cannibalization is quite what we expect. We genuinely expect the two products to exist side by side. Commercial payers have a different dynamic than Medicare and government payers like FFS and 340B and stuff like that. So what we see is that there are some markets where there's an advantage to having a reimbursed product and we would like to competitively service that advantage. So that's really about taking market share and we are consistently taking market share even in this current backdrop. We expect that market share acquisition to accelerate with Gozellix. Again, that's not in our guidance at the moment. So that's an update for later in the year. But it really is about a two tier. As Kevin said in his presentation, it's really about having a two-tier strategy that can deal with different price sensitivity and different reimbursement dynamics. And we think that's very powerful.

Okay, great. Yes, thank you for that. And so I guess, one last question. So I guess at peak, what do you expect? The Gozellix and Illuccix franchise, what market share are you expecting to achieve?

All of it. No, I'm just joking. I don't think we really put out an aspirational number. I mean, our goal, we chip away, we take, 2%, 3% market share every quarter. We continue to expect to do that. Obviously, again, because Gozellix isn't in our guidance, we haven't given an updated TAM with what we think Gozellix will do. I think currently our competition and ourselves have a very similar viewpoint, around what the size of the market is. It's around maybe the 600,000 scan level. We do see some opportunities to increase that market size. You should remember that probably 15% to 20% of the U.S. market still not reached in terms of scanner footprint and patient footprint. We expect to change that with Gozellix. The key attribute of Gozellix being a six hour shelf life instead of a two hour shelf life, which really gives us enormous reach out of nuclear pharmacies. You have to remember that the advantage of the nuclear pharmacy model is, as Kevin said in his Texas Twang, it's locally farmed to bedside or locally farm to scanner. What that means is that, when we compound that product or when we produce that product out of a nuclear pharmacy, there's nowhere where we can't go with Gozellix. And so we really get to pick up that patient population. And it's been well studied. You know, it's been well reported in our field that we have significant patient deserts. Patients travel two, three hours to the big smoke to get a PSMA scan. And, we can, if we can bring that to the patient, that gives us an enormous competitive advantage.

Okay, great. Yes, thank you so much for all that detail.

Your next question comes from Steven Wheen with Jarden. Please, go ahead.

Yes, thanks very much. I just wanted to go back to the guidance slide. I'm just wondering if you might be able to help us understand in the RLS revenue, what amount has been removed for double counting purposes. Giving the starting point for RLS revenues about US$158 million.

We haven't non-material. The RLS Illuccix component is non-material at this stage, so there isn't much to account for.

Okay, great. And so then the balance of the RLS revenue, just trying to understand the cost structure of that business that you've acquired. How would we think about the cost and sort of the profitability of that revenue? Obviously, it would look quite different to sort of just straight out Illuccix profitability.

Yes. So we're going to start reporting RLS as you have to remember that our acquisition has just completed. So we're going to start reporting RLS as part of the breakdown for Telix Manufacturing Solutions. I think for simplicity, if you exclude the impact of our product, you can assume that the RLS cost basis is neutral to Telix.

Okay, got it. And then just the final question I had just to help with some of the modelling. You've obviously been so busy with a lot of acquisitions. When we look at the cost structure, I'm just talking about G&A and sales and marketing lines. When we look at that for FY 2024, can we divide the second half of 2024 up and say that's a lot of those costs from those acquisitions are fully baked into those lines? Or is there further annualization of those costs that we need to be accounting for in FY 2025?

No, those costs are baked in. I mean there is some headcount growth in line with our general R&D and commercial plans. I think we've given guidance to the market previously on what we think that SG&A increase will look like. But again, I mean, I know, Steve, I know you're so focused on earnings and bottom line and everything, but it's just not our focus. Our focus is to reinvest everything we can back into our R&D platform, barring some reasonable risk management and balance sheet prudence. Right. So you should expect. And I think the numbers are there. Darren's gone through them. I think, it's going to be a continued trajectory from where we were last year.

Okay. I mean, I'm not that focused on it. I'm focused on the top line, but I just kind of. We've got to produce a whole P&L. So that's just helpful on that basis. Thank you. All right, thanks.

I think we're past the end of the hour, so I think if there are some remaining questions or some online questions, we had sort of a bumper attendance in this call, so we'll do a follow up separately. But maybe Kyahn, if I could hand back to you.

Yes, absolutely. Look, thank you very much. We have run over time. I will respond to the webcast questions and Darren and I are available today. But thanks for your attention and for tuning in.

Thanks very much, everyone.

That does conclude our conference for today. Thank you for participating. You may now disconnect.