Thank you for standing by, and welcome to the Telix Pharmaceuticals Limited FY 2023 results call. All participants are in a listen-only mode. There will be a presentation followed by a question and answer session. If you wish to ask a question, you will need to press the star key, followed by the number one on your telephone keypad. If you wish to ask a question via the webcast, please enter it into the Ask a Question box and click Submit. I would now like to hand the conference over to Ms. Kyahn Williamson, Senior Vice President, Investor Relations and Corporate Communication. Please go ahead. Thank you. Thank you, everybody, for joining our call this morning. You'll have seen that we have lodged our annual report and full year results on the ASX after market closed yesterday. Joining me today on the call is Christian Behrenbruch, our Managing Director and Group Chief Executive Officer, Darren Smith, our Group Chief Financial Officer, and Dr. David Cade, our Group Chief Medical Officer. If you just turn to slide four, please. Just a few introductory remarks. I mean, it's been a very exciting year for team here at Telix, and a lot of hard work, which has led to a lot of achievements. It's been our first full year of commercial sales with reimbursement of Illuccix in the U.S., and that's delivered a 214% growth in, growth in revenue to achieve a total revenue of just over $500 million. It really shows the strength of demand for Illuccix, but has also demonstrated our ability to build a highly effective and profitable commercial business. I think the operational highlights we've achieved this year are really driving towards our next phase of value creation. We are preparing to launch two new additional diagnostic imaging agents, subject to regulatory approval by the end of this year, and that will allow us to layer in new revenue streams and also, particularly in the case of Zircaix, further strengthen our offering to the urology field as a perfect follow-on product to Illuccix. You'll also have seen that momentum is really starting to build across the therapeutic pipeline. You know, notably, ProstACT Global is now enrolling patients, and we're preparing to roll it out into international sites. Our reputation for innovation has paved the way for several important acquisitions, notably Lightpoint, Dedicaid, and QSAM, which further enrich and differentiate our pipeline and end-to-end offerings. We target radiation at every step of the patient journey. Vertical integration of supply and manufacturing is a key focus for us as a business. The addition of Optimal Tracers and opening our Brussels South production capability further expands our capability and capacity in production, manufacturing technologies, and research and development. With that, I'd like to hand over to Chris to talk briefly about the financial metrics and other highlights for the year. Thank you, Kyahn. A great summary. So, moving to the next slide, slide five. This slide is a fairly self-explanatory slide and demonstrates what a transformational year 2023 was for Telix. Our record revenues of AUD 512 million, over 200% higher than 2022, were in line with or actually slightly ahead of analyst consensus. Notwithstanding a significant year of investment in our clinical programs, readiness for two further product launches from a manufacturing and regulatory perspective, and some pretty significant technology and infrastructure investments, we have really turned the corner in terms of our earnings, operating cash flow, and of course, and very importantly, our first profit. To reiterate the company's execution strategy, our commercial activities, which are currently centered around Illuccix, but soon to be a multi-product, multi-geography landscape, is there to fund our pipeline, particularly our therapeutic pipeline. We also invested heavily in our infrastructure and supply chain, as Kyahn mentioned last year, to be able to be ready for those additional revenues, revenue streams when they come on later this year. As such, our investment decisions are not passive decisions. They're based on a significant risk management, competitive landscape, and shareholder value creation strategy that's centered on a game plan for growth. Given the significance of our near-term commercial opportunities and our long-term value creation to our best-in-class or first-in-class therapeutic pipeline, we believe this investment is highly defensible and justified, and represents the best use of our earnings. The leverage we offer our shareholders is significant. If I can have the next slide, please. I've mentioned manufacturing infrastructure, and this was also a big area of investment focus in 2023 and will continue to be a focus in 2024. This investment focused not only on supply chain and partnership readiness for Pixclara and Zircaix launch, these are our follow-on glioblastoma and renal imaging products, but also scale up of our therapeutics development and delivery infrastructure. I'm pleased to particularly note that our Brussels South or Seneffe site, as it was formerly known, has now completed build-out and is now a commissioned hot site and is preparing for regulator inspections to properly go live later this year. This site significantly underpins our initial launch of our therapy programs globally, as well as servicing the European market for Illuccix, Zircaix, and other products when the requisite approvals are in place. Complementary to our Sacramento innovation location, we are also building out hot lab and development infrastructure near our corporate headquarters in Melbourne to be able to facilitate clinical trial activity in the APAC region, which is of strategic importance to the company. We are continuing to work towards a high degree of development and clinical self-sufficiency alongside carefully selected strategic manufacturing, isotope supply, and nuclear pharmacy partners. Finally, just as a side note, we've commissioned our AlphaLab, as we call it, at the Seneffe site. This lab, alongside the relevant investment in cyclotron infrastructure, enables us to internally explore future isotope production technologies around actinium, astatine, lead-212, and terbium. This is bolted onto the back of our, you know, extensive R&D infrastructure at the Seneffe site and includes two dedicated GMP lines that facilitate manufacturing scale-up.... This will be initially used for clinical trials, but in time will also be available for commercial use. This is really world-class infrastructure that most companies in our space can really only dream about on paper. The next slide, please. Finally, on the Illuccix front, you can see we continue to enjoy significant growth for Illuccix in the U.S. market. We had an excellent second half in terms of growth, with clear demonstration that we are taking market share, sitting at over 30% on a volume basis. We continue to capture significant oncology accounts, evidenced in our payer mix, as you can see from those two pie charts. We've seen stable pricing across all reimbursement categories. We have also implemented a price adjustment for 2024. So I think from a, you know, perspective, revenue growth perspective, you know, we're in, in really good shape. Most importantly, we are seeing just how challenging it is for new entrants to capture any meaningful market share. To take a piece of this market, it's not just about making a product and hopefully having a supply chain, and these are clearly both critically important, but also having the sufficient commercial infrastructure in place to effectively engage. 2024 will continue this trend of growth, and we'll speak to our guidance later in this presentation. We are progressing our European and other jurisdiction submissions on track and in line with process in each jurisdiction, so there's, there's no surprises there. We have disclosed the existence of an Illuccix lifecycle management program that will deliver further innovation for our customers in 2024 and 2025, and it really demonstrates our commitment to being at the forefront of urologic oncology imaging. In short, our customer base continues to grow because of our performance, our innovation, and our supply chain. These attributes are pretty hard to beat, and we'll continue to capture further share this year and beyond. Darren, over to you to provide further financial commentary. Okay. Thank you, Chris. Now turning through to slide nine, where we look at our revenue and Adjusted EBITDA. 2023 represents Telix's first year of Illuccix sales following its commercial launch in April 2022. Since then, and as you can tell by the graph, we have achieved significant month-over-month and quarter-over-quarter growth in revenue. By continually taking market share in the U.S., we estimate that we currently have about 34% of the market volume. As a result, Telix's total group revenue is $502 million, a $340 million improvement on the prior year. At Telix, we're not only focused on driving the top line, but we're also aimed to optimize the contribution of the commercial business and what it generates. We do this by assessing the commercial earnings before our investment into our asset development pipeline. As you can see in the graph, our EBIT before R&D has continued to improve in line with our growth in revenue. The commercial business, obviously, is a key funding source for the business. We then have two choices of how we spend these funds. We can either keep the earnings and pay taxes and a dividend, or we can reinvest them back into Telix's deep therapeutic pipeline to create future value for the business and shareholders. As Chris has previously talked about, we have decided to do the latter. Turning to slide 10, in the group profit and loss, we can see that in 2023, Telix has delivered its inaugural net profit after tax of AUD 5 million, which is an AUD 109 million improvement on the prior year. Most importantly, this result demonstrates that the company has built a self-sustaining business, where strong performing commercial business is funding a significant investment into the company's late-stage diagnostic and therapeutic assets. Closer attention to the P&L highlights that Telix's financial performance has improved not only on the top line, but across all investment categories. Gross margin has improved to 63% compared to the 59% last year, reflecting control of its manufacturing costs and optimization of its distribution network. The company has also continued to invest into its commercial capability to grow sales and ensure that we have the infrastructure to support a larger business. As can be seen in the resulting sales growth, has outstripped our increase in investment, thus reducing our expenditure as a percentage of sales, improving profitability and leveraging the P&L. This performance permitted Telix to invest AUD 128 million into our pipeline. This supports a third of our workforce that is dedicated to developing the product pipeline, along with AUD 86.3 million invested with our external development partners. Now turning to the cash flow on slide 11. At the end of 2023, Telix has achieved five consecutive quarters of positive operating cash flow, resulting in the ASX no longer requiring us to lodge our quarterly cash flow and activities reports. This is a signal Telix's maturation as a sustainable commercial business. This has permitted Telix to self-fund its product development through its commercial business while maintaining its cash on hand position. This has been supported by a continual focus on customer cash collections and a sound working capital management. It is worth noting that the positive operating cash flow was maintained during the second half of the year, despite including its first annual payment of AUD 16.3 million for the annual contingent consideration. Also, the filing fee for the Illuccix of $5.9 million, and funding the commercial manufacturing process, that qualification and validation for Illuccix and Pixclara. On slide 12, we can see the detail of the profit contribution from the commercial operations. It also, you can see this in note three of the financial accounts, which is our segment reporting. Clearly, the numbers presented speak for themselves and validate Telix's commercial strategy and its execution, with a growing top line and expenditure reducing as a percentage of sales. The significant sales growth and the continual market share gains is a result of Telix's directed investment into promotional marketing and growth programs, the establishment of 226-strong radiopharmacy distribution network, providing proximity to customers, and the build-out of a professional sales force and technical support services team that has enabled us to build deeper relationships with our customers. This investment will be further utilized when we bring to market our next product in Zircaix, FDA willing, during this year. Now, turning to slide 13, in our R&D investment. During the year, Telix invested $128 million into product development to create future value. As can be seen in the pie graphs on this slide, the investment was across three important components. The first bit relates to Zircaix and Pixclara in our lifecycle management, product development activities. 42% was directed to delivering these two late-stage diagnostics to commercial launch. This involved commercial manufacturing, process qualifications and validations, the preparation of the U.S. Food and Drug Administration filings, and the commercial launch. In preparing for the commercial launch, including the starting of early access, access programs to prepare the market for the launch. A further 25% was directed towards our late-stage therapeutic assets, for the preparation and commercial commencement of a large phase III randomized clinical study, ProstACT Global, and for the related clinical manufacturing processes to support the trial. The final 33% is, relates to Telix's internal assets, which is its development teams that are responsible for delivering the development of Telix's pipeline towards commercialization. In summary, Telix could be considered a biotech with a deep diagnostic pipeline that we have de-risked by building a successful commercial business that is growing and taking market share while funding our pipeline program development. I'll now pass you over to David Cade, Dr. David Cade, to take you through the pipeline. Thank you. Thanks, Darren. Always a pleasure to talk clinical. Moving on to slide 15, please. So this is our core pipeline that I think most investors are familiar with this. However, there's a number of key takeouts that I would like to highlight. If you look across the imaging portfolio, you know, there's a significant momentum, you know, for Illuccix beyond the U.S. commercial performance with that, which Darren and Chris have talked about. I think reflecting the truly global nature of the company, and specifically, you know, the global rollout of Illuccix, is currently awaiting a European approval decision, which we anticipate this year. And of course, over in the Far East, our registration-enabling phase III trial in China is recruiting very strongly, and it's on track to complete recruitment in the second half of the year. And that really does reflect the very strong and close collaboration with our partner, China Grand Pharma. What I'm really excited about is the momentum behind the first-in-class imaging agents, Zircaix for kidney cancer and Pixclara for glioblastoma in the brain, and getting these into the hands of our extraordinarily capable U.S. sales force. So I'll go into the market opportunity for these assets shortly, as well as some of the highlights of the progress the company's made across the therapeutic programs. Next slide, please. So when we look back over 2023, it really is quite astonishing, you know, what our development teams have achieved. You know, from new data generated from the therapeutic programs to the efficient recruitment of patients into ongoing and new trials and to the regulatory filings to the FDA for the registration of new products. This really truly is a huge amount of activity across the company's portfolio. If we look at the prostate program, the ProstACT SELECT study generated really valuable safety data toward the, towards the end of last year, and together with the CUPID study of Telix's targeted alpha therapy program, it's gonna generate further clinical data, including some early efficacy data during 2024. With ProstACT Global, which I'll give some more color on in a moment, it really was pleasing to see this phase III pivotal registration trial commence recruitment here in Australia, and I do look forward to opening, you know, this highly anticipated study in North America and other countries over the coming months. Turning to the CAIX program, it was very pleasing to file the first part of our BLA for Zircaix with the FDA in late 2023. You know, naturally, the target CAIX is expressed on a range of cancer types that have a poor prognosis, and we've seen some very, what I'd call encouraging data emerging from the OPALESCENCE study in women with triple-negative breast cancer. While on the therapeutic front, CAIX is a very active program, with the STARLITE-2 trial progressing very well, and we're expecting some initial data from this trial before the end of this year. Moving to the glioma program, it's pleasing to see the company make such rapid progress in this disease state. You know, it's a disease that continues, even in 2024, to have a very grim prognosis. With Pixclara, you know, for the imaging of glioblastoma, we've had extensive interactions with the FDA, and we have, I think, what we believe to be a clear path to an NDA filing for this, our third asset. On the therapy front, we continue to develop TLX101 in both the front line and the recurrent disease settings in the IPAX family of studies, and in IPAX-2, you know, with 101, where it's used in the front-line setting together with conventional radiation therapy and chemotherapy following surgery. This study is a dose-escalation study that aims to identify the optimal dose for TLX101 for us to take into phase II and ultimately registration-enabling trials, which we do plan to do, and initiate these towards the end of the year. I won't spend too much time on the rare diseases program. Suffice to say, our early-stage assets for soft tissue sarcoma and bone marrow conditioning will be heading towards the clinic for human studies this year. Moving to slide 17. This is the design of our multicenter international randomized trial, known as ProstACT Global, in up to 400 patients, which recently commenced recruitment in Australia. That was November of last year when we started that. So in this pivotal study, patients with metastatic castrate-resistant prostate cancer who've progressed on a prior androgen receptor pathway inhibitor or a chemotherapy agent, such as docetaxel, that have PSMA-positive disease. They're gonna be randomized on a two-to-one basis to receive either the standard of care with their second ARPI or docetaxel, plus TLX591, which is the investigational agent, or the standard of care alone with a very standard and highly used primary endpoint, radiographic progression-free survival. That's the primary outcome measure. And what I would like to get across is that we've done a huge amount of homework in designing this trial, which has had considerable patient input into its design, and it's really seen as a compelling study from both leading clinicians in this therapy area and importantly, patients as well. Next slide, please. So staying in the realm of prostate cancer, you know, Telix recently entered into an agreement soon to complete, to acquire QSAM Biosciences, based in Austin, Texas, and that company's investigational bone-seeking agent, known as Samarium- 153- DOTMP, which I'll, for simplicity's sake, call it DOTMP. And the reason for that is that it's the chelator that is critically differentiated in this asset. The reason we acquired this asset is because ultimately, virtually all patients with advanced metastatic prostate cancer will progress, and we see this as a highly complementary asset to our existing portfolio, given that the need for specific palliation of bone pain is truly such a hallmark of late-stage prostate cancer. So really, there are two major potential end applications of the asset in the clinic. Firstly, palliative management of bone pain caused by bony metastases from prostate cancer, but also from breast cancer and lung cancer, among others, that tend to exhibit skeletal involvement. And then secondly, it could be applied, you know, for the treatment of primary osteosarcoma or bone cancer, including in the pediatric population. Moving on to the imaging portfolio. I'd like to give a little bit more color around TLX250-CDx, which we call Zircaix. Next slide, please. This is how we view the U.S. market opportunity for Zircaix in renal imaging, which we've shown before and it really amounts to a total addressable market value of $500 million. That's U.S. dollars in the first instance, with the potential to expand this through new indications and the evolution of clinical practice guidelines. Zircaix is a first-in-class imaging agent for renal cancer that I believe may do for the staging and treatment decision-making around kidney cancer, as what PSMA- PET imaging has done over the last two to three years for prostate cancer. While we anticipate FDA approval for Zircaix towards the end of the year, we're putting in place an expanded access program to ensure ongoing patient and physician access to the asset prior to the FDA's formal marketing approval and the commercial launch of the asset towards the end of this year. So on the left-hand side, you know, really, there are two main clinical settings in which Zircaix may be used. Firstly, for the characterization of a renal mass that's been found in a patient, as either renal cell carcinoma or not. In other words, yes, as a surgeon, I'll need to take it out, or no, the patient may be suitable for more conservative management and active surveillance. And then secondly, in patients with known renal cell carcinoma, to accurately stage their disease, or for patients who've undergone surgery for renal cell carcinoma to provide longitudinal surveillance with imaging to enable the detection of recurrence of their disease, particularly in those patients with high-risk disease. And on the right-hand side, I won't go into too much detail, we've presented this before, but our initial market opportunity amounts to over 100,000 Zircaix scans a year, with, you know, very rich potential to bring the benefits of zirconium-89 PET imaging to adjacent indications. Moving on to Pixclara. This is our brain cancer imaging, and this is how we view the U.S. market opportunity for Pixclara for the imaging of brain cancer, which amounts to a total addressable market value of over $100 million from launch, but again, with significant potential to expand this through new indications. So we're getting very close with the FDA to filing the NDA package, and we're currently implementing an expanded access program again for this asset, so that patients can have access to it prior to the official commercial launch. So on the left-hand side, I think it's worth explaining how it may be used. We've outlined here three main clinical settings in which Pixclara would be able to provide clinical utility. So firstly, in patients with glioma, for which surgery and radiation therapy are the mainstays of treatment. Today, MRI is not able to distinguish in up to 40% of patients whether the patient's disease is responding to the treatment or whether it has recurred. So in this setting, Pixclara is better able to distinguish between what we call pseudoprogression, which is an artifact of treatment or true disease progression. And that's a critically important decision because these patients need to be actively treated. They don't have a long prognosis. Secondly, Pixclara, you know, by defining where glioma is most biologically active, could provide valuable information for radiation treatment planning. And then there's a third clinical application, potentially, where, you know, many other cancers have a predilection for metastasizing to the brain. So we believe Pixclara may have a role in the future in, you know, characterizing the status of the cerebral component of these diseases. And then on the right-hand side, you know, our initial market opportunity amounts to over 20,000 scans with Pixclara a year, and that's based on the annual incidence of 20,000 patients being diagnosed with a glioma. And unfortunately, these patients have quite a grim prognosis, typically a median survival of 12-15 months. So really critical for the physician to understand, you know, whether their disease is responding to treatment or progressing. So, with that, I hope that gives an oversight of the second and the third cabs off the rank in terms of commercial assets. And with that, I'll hand back to you, Chris. Thanks very much, David. Moving on in the package to slide number 23. So, this is our inaugural guidance to the market, as we transition to a rather different operating basis as a profitable company. We think it's appropriate to give forward-looking guidance. So our expected revenue for 2024 will be in the range in U.S. dollar terms of $445 million-$465 million. That's AUD 675 million-AUD 705 million at current exchange rates. This represents a 35%-40% increase over last year. I wanna make it very clear that this guidance is based on worldwide sales of Illuccix in jurisdictions in which we currently have regulatory approval. So it's not based on speculative or future approvals, it's based on approvals that we have today. There is, of course, upside in these numbers from the approval of Zircaix and Pixclara, which are reasonably expected this year, as well as further territory approvals for Illuccix over the course of the year. And as we get those additional product and jurisdictional approvals, we will then update guidance appropriately and accordingly. Additionally, we expect to invest around 40%-50% more in R&D compared to last year. This includes both, and you can see this from the little charts on the right, both the internal, you know, staffing and headcount and infrastructure, as well as external manufacturing and R&D costs. We expect to fund the entirety of our R&D activities through operating cash flow and broadly in line with this revenue growth, as you can see. I think if you take a look at the allocation of R&D investment going forward, you can see that there's a greater focus on therapeutic programs, and while we will continue to do, you know, to make further investments in our imaging programs. Really what you're seeing now is a transitional trajectory towards investment in our therapeutic pipeline. But I think for those shareholders that look at Telix's outlook as a healthcare company, clearly expanding our indications for our existing commercial programs, Illuccix's lifecycle management to maintain our presence in the market and to continue to innovate that platform, is still a meaningful investment for the company. Our 2024 R&D activity is really summarized in three major buckets. As David said, really getting the market launch in place for our two follow-on products, and you can see that the commercial opportunity of those products can certainly eclipse our current sales of Illuccix. Second of all, we are, we're pleased to be operationalizing our phase III trial, and that includes very shortly the U.S. as well. And we expect to also add European and additional APAC sites later this year. So really, that's a significant part of that therapeutic investment allocation to the right. And of course, you know, the broader pipeline still remains important as well in terms of in terms of progressing progressing ahead. And then finally, clearly the you know the lifecycle management of Illuccix and ongoing indication expansion and really maximizing our competitiveness for our core money earner right now is a key focus for the business. Moving on to the next slide. So just to summarize, I think this is a very comprehensive viewpoint of Telix. It summarizes the prospects of the company very nicely. We have a fantastic pipeline of late-stage therapeutic programs that are making tremendous progress, and I think David really eloquently articulated all of the clinical progress that we are making. We're recruiting patients every day and every week, and every month into those into those programs, and we have a ton of data readouts over the course of the year. So I encourage you to go back and have a look at the pipeline slide and, and look at the milestones that are associated with each asset. This year, our commercial team is going to be super busy with the launch of two further products and geographic expansion of Illuccix. And we are currently commercially active in four jurisdictions as an approved product. I expect that we will be active in over twenty jurisdictions by the end of the year. So this is really a massive year of geographic expansion and, of course, revenue de-risk. And of course, we continue to make sure that our lead program is the best prostate cancer imaging agent in the market. We also have our future pipeline, you know, the Telix in five years, pipeline coming in behind. We're gonna have some exciting opportunities to talk about our next generation products, particularly our alpha programs, over the course of the year, and we will continue to invest where appropriate and where it's complementary to our existing partnerships in vertically integrating our supply chain and manufacturing activity. And I think everybody on the line knows that's a critical activity for a radiopharmaceutical company, particularly one of our size and stage of commercial development. So I'll leave it there. That's the last slide in the presentation. And I'd be pleased to open it up to the floor for questions from analysts. Thank you. If you wish to ask a question, please press star one on your telephone and wait for your name to be announced. If you wish to cancel your request, please press star two. If you're on a speakerphone, please pick up the handset to ask your question. If you wish to ask a question via the webcast, please type your question into the Ask a Question box. Your first question is a phone question from David Stanton with Jefferies. Please go ahead. Morning, team, and thanks very much for taking my questions. I wonder if you could give us an idea of where, what you're thinking for percentage gross margin for F 2024. Should it be similar to down on F 2023, given you've had that... You've taken price? I don't think that we're expecting a great change. We see plenty of reasons to have pricing stability remain in 2024. We haven't seen the competitive perturbations around pricing yet that really gives us concern around gross margin. We also continue to invest in manufacturing infrastructure and operational improvements that will, you know, continue to maintain or perhaps even slightly improve gross margin. And then clearly the follow-on products, I mean, Illuccix has a certain production and distribution profile. The follow-on products have some similarities with Illuccix in terms of their cost base, but I think that that sort of 65%-70% gross margin should be taken as an indicative gross margin for an imaging product in the Telix portfolio. Understood. In terms of... Second question, in terms of ProstACT SELECT and the PFS data that we're looking forward to seeing, we should still be thinking around the middle of the year, calendar 2024, for that? Well, it's a bit hard to say, David, because, you know, it's an event-driven process, so, you know, and unfortunately, a certain number of patients have to progress before we can make that readout take place, and those events have not yet happened. We closed the trial last May. We disclosed that publicly. So, you know, we're still waiting for adequate progression data to enable us to give that readout. But best guess at this point in time is sometime around the middle of the year. Obviously- Interesting. And last one- It's one of those perverse things, right? Where longer is better in some respects, even though it's- Understood. It's frustrating for the market. ... Understood. And finally, last one from me. You know, thanks for the extra clarity on the contingent considerations. You know, the ANMI contingent consideration looks like it's around 10% of Illuccix sales. Is that correct? Just broad brush. Thank you. Broad brush. I mean, it's, there is some—there are some costs that are deducted from, from that, but, that's, that's roughly correct. And obviously, I mean, we're only paying this consideration out as a function of commercial success. It's not, as we've disclosed to the market before, it's not a never-ending contingent consideration. It's only for a period of time, and there is the ability to terminate it after three years. So, this is something that people are just gonna have to get used to seeing. It's a function of our commercial success. Understood. Thank you. Your next phone question is from Laura Sutcliffe with UBS. Please go ahead. Hello, thank you for taking my questions. First one is just on the preparations for the Zircaix launch, please. What sign-offs in terms of manufacturing facilities do you need to get it launched in the U.S.? Yeah. Good morning, Laura. Thank you for your question. So, you know, we have fully engaged the manufacturing infrastructure that we will be using because, in order for us to engage in a BLA submission process, those things need... Those manufacturers of record need to be defined. We haven't, for commercial and competitive reasons yet, disclosed to the market who our manufacturers will be, but obviously as we start to get ready for commercial launch, that information will come into the public domain. But, as of this point in time, all of the infrastructure that we need, ranging from raw material production, antibodies, production systems for zirconium, nuclear pharmacy partnerships for distribution, which we have several, that infrastructure is all in place and validated for commercial launch. All right, thanks. And then a second question, just on Illuccix and Pass-Through payments. I'm sure you're extremely bored of this topic, but I think Lantheus said overnight that they think about 20% of prostate cancer patients are impacted by that, price reduction as a result of the end of Pass-Through. I think that's somewhat lower than I, than what we've assumed for Telix, and therefore our forecast could be a little bit too harsh. I realize you can't comment on Lantheus's business, but perhaps you could tell us what you think that portion looks like for Telix. Well, we don't have... I mean, you are, you are right. I'm more than bored of the topic of passthrough, but I can also understand why it's an important topic to kinda get right. You know, Lantheus and Telix don't have a terribly different payer mix, and, you know, the, the impact of passthrough has a very defined payer nexus. So I think it's relatively straightforward to calculate. I don't think Lantheus's commentary is too far off the mark. I think that, you know, we have to remember that passthrough only affects a certain segment. So there's a certain analyst model that implies that when passthrough ends for one vendor, it just kind of moves to the next person because there's some expediency in that. In practice, we all service customers that have multiple payer segments, and so the net result is you're going to see a, you know, a drop in ASP across the average of those payer segments. We don't think that drop is dramatic. We think that the market will continue to grow, that the top line of the business will continue to grow, even in a post passthrough environment. We think that, you know, our customers are sticky and have chosen our products for a reason, and remain loyal to the product. And I think Lantheus would make a similar claim, given that we are competing effectively with each other in the market. And I think we would both agree that the appearance of new entrants, you know, hasn't been particularly dramatic or successful. So I think that customer relationship continues to be an important factor in how the market plays out over the next 18 months. That said, we don't take any chances on passthrough, so while as an industry, it's, you know, it's a topic that has a lot of spotlights from an analyst perspective, clearly a lot of people are thinking about it. We're gonna make sure that when our passthrough expires, that we're in the market with a lifecycle management that preserves our position in the market. And so we, you know, have a multipronged approach to managing our position in the market, which is about maintaining our ongoing commercial relationships, being part of an industry-led reform of the reimbursement landscape for this class of products, and then also, you know, making sure that our lifecycle management strategy specifically addresses the topic of passthrough. Does that answer your question? Yeah, very much so. And it leads to my last question, which is: Is there anything you can say to us at the moment about the opportunities for lifecycle management of Illuccix? We've been working really hard on this for many months, and we expect to have a follow-on product filing in the first half of this year. We will give more detail to the market at the time at which that filing takes place, including the- All right. indications associated with it. Thanks very much. Thank you, Laura. Once again, if you wish to ask a question, please press star one on your telephone or type your question into the Ask a Question box. I'll now hand back to Ms. Kyahn Williamson to address any webcast questions. Thank you. Our first question from the webcast is: Is the bulk of R&D spending in FY- going to occur in FY 2024, or do you anticipate similar levels or of R&D over the next few years? I don't really understand that question. We haven't given guidance beyond FY 2024, but again, I think it's worth reiterating what the commercial strategy of the company is. We believe that the best use of our earnings is to reinvest into the company's pipeline. That doesn't mean that over the course of time, we might take a more diversified view of where our earnings go. I mean, I think I'd speak on behalf of Darren. We'd like to see maybe a little bit more allocation to risk management, a little more allocation towards building a balance sheet that gives the company optionality for strategic transactions. So I think, you know, there's plenty of things that can be done to grow the business with that cash, and of course, to risk manage the business. But for the foreseeable future, you know, shareholders should understand that we are going to invest proportionately into our R&D programs. We have a terrific pipeline. We've shown already that we can build $2 billion of enterprise value in the company just with one product. We have a follow-on pipeline that has near-term commercial prospects, where we can significantly increase that enterprise value. And so, you know, our strategy is to continue to do that. And clearly, the big prize in all of this is our therapy programs, and over the last couple of years, we've been able to invest and develop those therapy programs to the point where, you know, they're on the cusp of adding value to the business as well. So I think in a nutshell, that's the game plan for the company, and isn't gonna change in the near future. Thank you. Our next question is: I understand the growth in R&D and sales and marketing investment. What is driving the growth in admin expenses? Is the go-forward for this to grow much slower than revenues? Yeah, I mean, and I mean, you've seen it over the course of the last three years. Our admin costs as a proportion of revenue has, has decelerated significantly, and we expect that trend to continue. SG&A is not going to grow at the same rate as our revenue, because the incremental cost of prosecuting the current commercial opportunities is much lower than the revenue streams that they enable. So, I mean, just as a kind of a rough, you know, a rough kind of signal, you know, we would expect SG&A, which is predominantly U.S. SG&A. Of course, Europe will also increase a little bit around the middle of the year, as we expect to get our, our regulator guidance around Illuccix for the European market. But, you know, so second half of the year, Europe will increase a little bit as well. But for U.S. SG&A, you know, we expect to see, you know, a 15% increase this year, and that's clearly a much, much smaller, you know, increase than the expected revenue forecast. So I think that modest SG&A increase is what should be reasonably expected from a commercial evolution of the business perspective. Hope that answers the question. Thank you. Our next question is: when do you expect to complete the rolling submission for the Zircaix? Great question. We actually have answered this question in the public domain before. Our agreed timeline with the agency is to have it completed by May. Thank you. And what will be the trigger for the ProstACT Global interim readout, and what type of data do you expect to report? Yeah, so we'll be talking a lot more about the ProstACT Global study over the coming, over the coming months. You know, a lot of it is dependent right now on getting our IND finalized with the FDA, which we're making great progress on. That's an imminent event. That trial design will then obviously be, you know, much more the focus of investor attention, and we'll be spending a lot more time talking about it. We do expect, on the basis of our current clinical recruitment plan, to have an interim readout that would be able to provide a preliminary PFS signal, from the global trial. We would expect to have that readout recruited by around the end of Q3 of this year, and that would lead to a first half of next year, likely, interim readout from the study. We've designed that interim readout in such a way that it will enable us to compare to the PFS signal from ProstACT SELECT. I'd like to remind you that the ProstACT SELECT trial, while it's a similar patient population in some respects to the ProstACT Global trial, it's a little bit more advanced stage patient. So I'd describe the patient population as somewhere between ProstACT Global slash PSMAfore trial and the VISION trial. So it's sort of in the middle. It's a mixture of those patients. So the PFS result that we're gonna get this year is gonna be a really interesting kind of flag in the sand for PFS. And then we want to be able to compare that PFS to what we see in the ProstACT Global Trial, which is in a true second-line patient setting. And again, to reiterate, we expect to be able to do that in the first half of next year. So yeah, these, these commercial milestones are not far off for the ProstACT Global Trial. Your next question is a phone question from Laura Sutcliffe with UBS. Please go ahead. Oh, hello, thank you for taking yet more of my questions. Just one this time around. I think you mentioned just now, and sorry if I misheard, that there would be opportunities to talk about the alpha emitter at some point this year. Could you just give us a little bit more color on what you hope to do there? We actually have several alpha programs, but I assume you're meaning, 592. I do, yeah. So we have actually completed the CUPID trial. We're expecting, you know, we're just going through the machinations right now of closing out that study and reporting data, and we should have a readout to talk about to the market in the next couple of months. Thanks. Your next question comes from John Hester with Bell Potter. Please go ahead. Good evening, Chris. Just on the interim readout from the ProstACT SELECT study. We've got a few data points there from competitors in the market, PNT2002 did a rPFS of 9.5 months, and the Novartis product did 12 months. What's the sort of number, ballparking, that you would hope to achieve, with ProstACT SELECT? And what would be the number that you kinda have to consider that this trial is not worth progressing if you didn't achieve a certain level of rPFS? Well, we wouldn't give speculative guidance on what a PFS might or might not be. I think that if you look at the range of trial PFSs, they range from mid-sixes up to... Not quite sure your summary PFS is quite right there on VISION. But nonetheless, you know, the range of PFS tends to be in the six to seven and above. And I think that we always have to remember, and clearly we have published PFS data for this asset before, so you can go and historically look that up. But I think that fundamentally, PFS isn't a strong indicator of overall survival. So it's really more of an indicator of whether our dosing regimen is effective or not. Yeah, we'll look forward to providing that update when it's available. Just, you know, to remind you of my earlier comments, we finished recruiting the ProstACT SELECT study in May of last year. So we're still waiting for, you know, sufficient events to be able to report this study out, and so giving guidance beyond that at this time isn't feasible. Fair enough. I wasn't actually referring to the VISION study in my earlier comment. It was the subsequent Novartis trial, but I won't get hung up on that. But you said that rPFS is not an indicator of overall survival. Is that... Did I understand that correctly? Is that- That's correct, yes. Yeah, so across every study that's been performed with these assets with the PSMA class of assets, and indeed many of the androgen receptor inhibitors as well, PFS is not a strong predictor of overall survival. So it's a useful measure- Okay. It's a useful, useful measure of whether or not something's worthwhile taking a deeper look at, but it's not really a prognostic measure. Okay. Well, perhaps we'll explore that offline, but thank you very much. That's all. Yep. Is there another question? There are no further questions at this time. I'll now hand back to Ms. Kyahn Williamson for closing remarks. Yes. Look, thank you very much for your attention today, and for the questions that have come through. We really appreciate the time taken to tune in, and we'll be looking forward to keeping you abreast of our progress over the coming year. Thank you very much, everybody. Thank you. That does conclude our conference for today. Thank you for participating. You may now disconnect.