Telix Pharmaceuticals Limited

Welcome to the T-Lix Full Year 2025 Results and Investor Webcast. At this time, all participants are in a listening mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Kai 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 lodged our annual report and full year results on the ASX about 30 minutes ago. We also have the slides on the screen by our 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 two, I'm very pleased to have on the floor with us today Chris Berengrook, 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 therapeutic business. If you can move to the next slide, please. I am required just to give you an excerpt from our forward-looking statement, the same statement. So please note that on today's presentation includes forward-looking statements including within the meaning of the US Private Securities Litigation Reform Act of 1995 that relate to, among other things, anticipated future events, financial performance plans, strategies and business developments. These forward-looking statements are based on current information, 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 SFC including in our half-year and only report. The report should not rely on forward-looking statements which are made as early as today's date and the company defends any obligation to update such statements. Please refer to this 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, Kai, 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 five. Over the last 12 months, we started to put the depth and execution around what has been a multi-year corporate development strategy. It's useful to think of T-LIX as a platform with these five 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 three 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 a billion dollars for an asset that has been in a few months, 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 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 the 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 positions and drive preference towards our product. There seems to be some background noise. If somebody needs to mute, they should do so. 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're dealing with products that have shelf lives 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 half a billion dollars in the last year's 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 hypergrowth business, and it generates the cash we need to aggressively expand, further diversify our revenue, and dominate the field. Slide seven, 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 800 million U.S. dollars or over 1.2 billion Australian pesos for anyone that prefers their greenback served with shrimp on the barbie. Our margins have remained extremely stable despite competition, and this excellent commercial performance enabled us to invest half a billion dollars into growing our product pipeline, funding the best commercial team in the industry, and building our infrastructure and supply chain. Think about that. half a billion dollars to grow the future value of a company from earnings without shareholder dilution. Telex is a very unique and valuable story. Moving on to slide eight, 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 Telex 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 Gazellex that also leverages the Artemis isotope production acquisition. The launch of Gazellex has been successful, and it 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 Zerkayx being the next, you know, prime example of this. of this technology platform. Two, we have two new products to launch, PixClara, which is known as PixLumi in Europe. This is for glioblastoma, and Xerkayex 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 four out of five of these studies are pivotal or phase three studies. We have imminent data point coming out on PROSPECT Global, which we will take to the FDA to gain clearance to commence part two in the United States. And I remind you that the study has already progressed to randomizing patients ex-US for part two of the study. I'm going to talk a little bit about this later in the presentation. Our bypass biopsy study will complete enrollment this year, and we expect to generate significantly enhanced revenue in 2027 as a consequence of this phase three study. Our current late-stage clinical studies paved 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. Okay. 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. Sorry, can I just ask, I think there'd be... Hello? Hi Darren, your line is open.

Pardon me, Darren, please check your mute button. Make sure you're not muted on your own.

So this year... Sorry, can people hear me now?

Hi, Darren, yes, we can hear you. Your line's open.

Okay, thank you very much. Okay, this is in line with our uplifted full-year guidance, and notably, it's our third consecutive year of delivering double-digit 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 Valutics and the launch of Gazelix. The precision medicine commercial performance committed Telex to self-fund and de-risk 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 practices. 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 Greens and that 94% of the GN is generated from our precision medicine business. That is approximately $400 million. As you can see, about half of the gross margin, the Red Flow team, 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 recognise 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 to bank is pretty damn attractive. Now moving to our traditional P&L. I've spoken to most of the financial highlights from the previous slides, but we'll 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've posted an adjusted EBITDA of $39.5 million in line with market consensus. Now moving to our next slide. Kirlik's precision medicine business is clearly our cash machine. Its financial metrics demonstrate its excellent performance. Precision medicine delivers an additional $113 million in revenue, representing 22% year-on-year growth, alongside a 28% increase in operating profit and a 25% increase in the 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 Gazellex, the geographic expansion of Ellucix, and the launch readiness activities of PixClara into KX. As a side comment, if this was a standalone business growing at 20% plus per annum, on an extrinsic value basis, it would be worth up to eight times revenue. This is a huge value creation for shareholders. Now moving to our next slide until it's 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 modelling. As you can see, RLS delivered positive EBITDA for the first 11 months post-acquisition. At the remaining CMS facilities, 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 CMS as one segment. for commercial and competitive reasons. Now moving on to cash flow. As you can see in this cash bridge, Telex continued to generate strong operational cash flows, which we then invest into our pipeline. In 2025, Telex 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 Illusix, 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, till it's utilised cashed on hand, to support targeted strategic investments, such as RLS and Maginab, and in our FAP assets. 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. R&D investment is planned to be in the range of $200 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 two to three years, We expect to grow revenues by advancing assets from clinical development to commercialisation, expanding indication in 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 optimising new-term earnings per share. We are committed to building long-term value. We believe prioritising earnings too early can impede the strategic investments required to fully unlock the potential of our pipeline. Next slide, please. Teelix 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 four areas of focus, and they are investing into our R&D, optimising our commercial performance, strategic growth opportunities through M&A, and supply chain resilience and production capacity. We believe these four 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 back on the balance sheet. Next slide, please. Looking forward, we see strong momentum heading into 2026 with another year of roughly 20-plus per cent revenue growth anticipated. Our full year, 2026, revenue guidance is set at 950 to 970, 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 in a full year of RLS revenue. Our corresponding R&D investment will be in the range of $200 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 investment 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 a LUCIX transitional pass-through status and the transition to MUC, M-U-C, 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 F18 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 T-Lix in the market. Our reputation as an innovator also positioned us for a successful launch of Gozellix, Gozelex 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 two 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 non-negotiable. 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. Competence 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 longstanding 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, lifecycle 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. ILLUSIX is now available in 17 countries with reimbursements 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 UK, 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've 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 Gozelex 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. Bypass is a phase three study that represents the next wave of innovation. combining PSMA imaging, elucics, or gozelics 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 Sarcaics, we've completed two 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 ZirconX 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 US. TLX101-PX was filed with the European regulators recently, and the US 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 advance 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 lifecycle 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 Gozelex certainly de-risks this. With indication expansion in prostate cancer alone, particularly a major opportunity in the bypass study, this growth over the five years can be closer to a 30% CAGR. And then when you add in Pixclara and Xercaix, 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. And 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. Okay, 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 if it's a standalone business. But it's our engine room, and the future growth trajectory of the business will come from how that cash is invested. Kevin's already shown you very clearly, I think, how the precision medicine business alone can grow expansively over the next five 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 to 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 five years or so. And on a TAM base, it's actually pretty conservative. But the therapeutics opportunity is about three or four times 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 9 and FAP, can potentially expand into. So, it's a really bright future for the seranostic strategy. Moving on to slide 27, please. Over the last five 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 multi-product concentration areas. Frankly, much as we have done with gazellics and illusics on the precision medicine side of the business. Indeed, to tackle some of these major unmet clinical needs is 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, you know, well-considered combination therapies with standard of care medical oncology. This is evident already, for example, in the design of the Prospect Global and IPAC Sprite studies. There are three particular attributes of our pipeline that I'd like to specifically comment on. Firstly, by taking a theranostic approach, we build 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 is not exhaustive, this list, because we have a pretty decent preclinical portfolio coming in behind, we have three 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 targets, learning about disease, extent, 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 image 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 the 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 four major trials to watch this year are outlined here. I'm not going to go blow by blow on this 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 three 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 PROSTAC Global Study. This study is now recruiting into part two, randomized part of the study, XUS. 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 pre-specified 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 PROSTECH Global Study. To remind you, the data we will be putting out from Part 1 will be safety data on the three standard of care combinations in the Global Study, as well as comparative dosimetry data, which will be very interesting to see, particularly for the two 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. why we are here. This slide illustrates four patients and four 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. Other 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 we'll 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 agent that we are also developing, and highlights 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. Okay, 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 three major catalysts being resubmission of PixClara and, of course, Archaics, 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.

Thank you. As a reminder, To ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We will take questions from analysts on the phone first. Please limit your question to one at a time and hop back in the queue. If we do not get to your question, we will respond directly, including the questions on the webcast. Please stand by while we compile the Q&A rosters. Our first question comes from Laura Sutcliffe with Citi. Your line is open.

Thank you for taking my question. 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 5910, the safety data, And perhaps, given that you've 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 TELIC or whether you're waiting for the FDA to do something on their end to be able to get to that point.

Yeah. Hi, 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 XUS. However, in order for us to send the information to the FDA and disclose the information publicly, we need to just to complete the clinical case report forms and formally close out and, you know, 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.

Thank you. Our next question comes from Tara Bancroft with TD Callen. Your line is open.

Great. Thanks very much for taking our question. 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 into what you've seen in the early innings of the two-product strategy for Lucec and Valzellic and how you anticipate that will evolve this year to reach the 25% growth in the precision medicine revenue. Thanks.

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

Yeah. Thank you for the question. So the two-product strategy is, you know, enables us to really manage the economic needs of HOPS 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 mean unit cost has really kind of changed the environment and the reimbursement environment there as well as the way that the pricing changes. happens in the HOPS accounts. So being able to have a two-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. 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 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.

Thank you. Our next question comes from Shane Story with Canaccord Genuity. Your line is open.

Good morning, everyone. Kevin, I'm going to stick with you if that's okay. Question on PICS Clara. 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-worked example for how the variant relationship might evolve? Just some thoughts on that, please.

Kevin, are you there?

Yeah, so I'll take that first then, Chris. So, you know, Varian is – we're really excited about the possibilities in that. A lot focused, of course, on PSMA and Eleusis Gozelex. And so, you know, 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 neuroscanning. 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 new med 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 site. And, of course, if that is not an ILLUSIX 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.

Thank you. Does that answer your question, Shane? Okay. Chris, anything to add? All right. No, that's good. We'll move on to the next question, please.

Our next question comes from David Stanton with Jefferies. Your line is open.

Good morning, team, and thanks very much for taking my question. I might be following you 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 zero NPAT for F26, F27, and F28. Is that what the market should be thinking going forward, please? I ask because it's the question I get asked the most. Thank you.

Yeah, that's fine. No horses 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 but a profit objective for this year and next year is not the name of the game.

Thank you. Our next question comes from David Bailey.

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. Can we move on to the next question, please?

Next question comes from David Bailey with Morgan Stanley. Your line is open.

Yeah, thanks. Hi, everyone. 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 these sales strategies, guidance for 26 and the R&D guidance for 26, you know, should we think that if the commercial performance is at the upper and lower end of those ranges, the R&D will follow and as an extension of that, within the R&D spend, you know, is the earlier stage, you know, 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? Thanks.

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 five studies, including the BIPOC 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'll be outside of that sort of ring-fenced five studies, the four therapeutic studies and the bypass 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. Shall we move on to the next question, please?

Thank you. Our next question comes from Craig Longpond with RBC. Your line is open, Pat.

Hi there. 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, you know, 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 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.

Shall we have the next question, please?

Thank you. Our next question is coming from Andy Shy with William Blair. Your line is open.

Yeah, thanks for taking our question. Chris, I wanted to ask you about your recent collaboration. Can you hear me?

Yes, go, please.

So, Chris, I want to ask you about the recent collaboration with ATLI and Stanford focusing on Anthropocene 211. So, in your pipeline, you have three alpha emitters, actinium 225, you have lead generator that's in progress, and then now acetine, you know, 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. Thanks.

Yeah, so it's a bit of sort of outside of the major sort of activity area, but essentially we do see value in alpha emitters. You know, 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 alphas coming over the horizon. As you note, 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, TLX-102, 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 radiometal with a chelator. So, we are exploring astatine mostly in the CNS setting. And then we do, as you note, 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.

Yes, certainly. Thank you.

The next question, please.

Thank you. Our next question comes from David Dye with UBS. Your line is open.

Great. Hey, thanks for taking my questions. Just on the gross margin for business, it seems like it's remaining stable at 53%, but then the RLS business gross margin has been, you know, 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, 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 Telex products. These are, for the most part, fairly generic nuclear medicine products, and RLS's 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 T-Lex 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 Telex'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 freaks 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?

Yeah, that makes sense.

Yeah. So, yeah, so don't be sidetracked by RLS. The most important thing is that when we put our products through RLS, that gross margin number, which, you know, we report faithfully for the precision medicine business as sort of mid-60%, 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 and 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%.

Thank you. Thank you. Thank you for your question.

Thank you. Our next question comes from Andrew Payne with CLSA. Your line is open.

Yep. Morning. Thanks for taking my question. This may be one for Kevin, but you mentioned winning in the PSMAs 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 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's done a great job of running through what the competitive barriers to entry, and they're multiple. I mean, it's not just product. It's also clinical. It's also manufacturing and supply chains. 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, you know, generally speaking, we've seen a step change in sensitivity on pet cameras over the last three to five years because of the demand for pet imaging, not just in prostate cancer, but across a whole lot of indications, including neuro-oncology, you know, neurodegeneration, cardiovascular disease. We're seeing a lot of camera installation going in, and the next generation of scanners are an order of magnitude more sensitive. And so that, you know, 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 In 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 an anagram per mil. 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?

Thank you. Our next question comes from Melissa Benson with Bear and Joey. Your line is open.

Thanks for taking my question. So Kevin mentioned you had a full alignment on the agreed deliverables with the FTA for the take.

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

Oh, I'm sorry. Okay. So I think Kevin was mentioning there was alignment on the agreed deliverables with FDA for the cakes. 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, you know, preclinical analytical data only.

Yeah, 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.

Thank you.

Yeah, no worries.

Thank you. Our next question comes from Steve Wing with Chardon. Is there another question?

Yeah, good morning. Chris, can you hear me?

Hello? I guess we've lost that one. Anybody else? Chris, are you there? Yes, I'm here.

Yeah, okay. 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 Elucyx and Gazellex, I guess. 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 US has a much more immediacy between product approval and reimbursement, whereas In Europe, sometimes there can be as long as nine 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. And so until you have reimbursement, you simply don't have material sales. So for what you would classify as the traditional EU5 countries, We have only just received reimbursement in some of them. Kevin, I don't know if you want to add anything there.

Yeah, there's very little other color to add than my prepared remarks, which was really 2025, the international team under that direction was really focused on gaining market access through reimbursement. And now in that EU5, the plans now are to execute those market launches. And so you'll see You'll see that as we continue to grow in 2026 as we execute against that launch. But Chris is right. Each country is different. Each product is different. So it takes a bit to get that approved and in the system and then begin the launch. So we're in the midst of that right now.

Right. Okay. That's clear. Can I just ask an unrelated question just with regards to your R&D? Sure. The expensing of the cakes 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.

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

Fantastic. Thanks, Christian.

Yep, no worries. Thank you. Our next question is a follow-up from Shane Story with Canaccord Genuity. Your line is open.

Sorry for extending the time, everyone. My question was going to come off the back of Melissa's question, actually, on the case, 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 six months. We're just unsure how the breakthrough status and priority review might influence that, if at all. Thanks.

Yeah, we don't know yet for Xerkayex, 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 of CRL. We could imagine for the Zirkaix 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 Zirkaix. Thanks, Chris. Yeah, no worries. But, you know, I do note that it has a breakthrough designation. And, you know, 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, you know, 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. Your line is open.

Thanks. Saving the best till last. Chris, I note that you've talked to part two, 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? Thank you.

Yeah, you know, obviously, I get increasingly reluctant to estimate timelines on clinical trials because we don't 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, 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.

Thank you.

Yeah. Okay. 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 for the 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. And 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.