Good afternoon, everyone. My name's David Low. I cover healthcare for J.P. Morgan in Australia. Well, thanks for coming back this afternoon. With us today, we have Chris Behrenbruch, CEO of Telix Pharmaceuticals. Chris is going to run through a presentation, and then there may be a bit of time at the end for Q&A. Over to you, Chris.
Thanks very much, David. I appreciate the opportunity to tell you all about the company and all the progress that we've made in the last year, as well as our outlook for 2025 and beyond. Just the usual customary disclaimer. So, I know that radiopharma is a hot topic, and there's a lot of interest in the space. We're more from a U.S. investor perspective more of an emergent company. We're about 10 years old, but we're sort of just new to many of you. So I thought I'd start off by telling you a little bit about the company and the space that we occupy. Our focus is purely on theranostics in the oncology space. We see just an enormous potential for the role of targeted radiopharmaceuticals in oncology, both from a precision medicine diagnostics perspective, as well as of course therapeutically.
I think that's really the ultimate value creation in this space. And I thought I'd just show a couple of cameos from our pipeline. We have an extremely deep pipeline, which I'll go through in quite a bit of detail in this presentation. But I think to illustrate why this dovetailed approach of diagnostics and therapeutics, or theranostics, is so elegant. And so you can see two examples here, one in a glioblastoma patient, one—and I think it's a—I think it's a relapse medullary thyroid patient or something. I forget what the patient is. But what you have is, with an imaging agent, you can come in and you can—whether it's a more localized disease or a whole-body systemic type of application—you can really characterize the extent of the presence of the disease, of course, if you have a good target.
Then the middle panel is actually showing, with imaging, in this case, in both examples, SPECT imaging, single photon imaging, actually shows the biodistribution of the drug itself. And then, again, by interrogating with PET or SPECT imaging post-treatment, you can see and quantify very accurately the change in treatment response. And we are seeing, I think, as we explore the target space in radiopharma, we're seeing astonishing treatment responses in really late-stage cancer patients. And so it really bodes well, I think, for the future of the field. But I want to draw this to your attention because a lot of emerging companies in this space focus purely on therapy. And when we develop radiopharmaceuticals, we get two things. We get, you know, an efficacy, you know, an index of therapy, and we get a signal. And that signal is the imaging piece.
If we don't develop both of those things, we're really not optimizing development against an individual target. And so that's something that, you know, we think is extremely important and underpins the core strategy of our company. So we're a very unique company. We are a pure-play radiopharma company. We are commercial stage. We did about $500 million in revenue this past year. I'll go into more details on that in a second. But we're building a global commercial team that's very capable in the disease areas that we service. We have an extremely deep pipeline, both in the diagnostics and the therapeutic space, and I'll go through the major components of that in a minute.
And then the third thing, which is also a sort of corollary to the reality of radiopharmaceuticals, is that, unlike most other areas of medicine, from the time that we make our product radioactive, it's essentially a decaying product. It's a melting ice cube. And so, in order to be credible in the radiopharma space, you really have to have command and control over your supply chain. You have to be able to get a product to patients that is a just-in-time manufactured product. And I'm bound to tell you that most of the complexity and a good deal of the intellectual property of radiopharmaceuticals is in the manufacturing and scale-up and supply chain aspects, and they cannot be sort of discounted in terms of their importance. And so these are the three unique assets that we're building within our company.
We actually view our commercial team as an asset. It's not just a bit of SG&A. It's actually addressing a fundamentally challenging problem, which is how do you sell radioactive drugs to specialty medical areas? How do you get a medical oncologist excited about radiopharma? It's a very, very tough sell. It's very content-driven. It's very specialist. It's very cross-functional. And so our commercial team is an absolute asset as we prosecute the opportunity of this business. This will be the only sort of finance performance slide I'm going to put. We just put out our top-line revenue results for last year. We had really spectacular growth year on year. We've prosecuted consistently quarter over quarter. You know, we see the markets that we're in having all the indications that we're pursuing have great growth potential, you know, well into the future.
We will be putting out our guidance for 2025 in the third week of February when we report our complete FY24 results. So, yeah, really good result. And, you know, not to put too fine a point on it, but we are financing the bulk of our R&D out of earnings, which I think is a very unique position to be in for a company of our stage and relatively early journey from a market cap perspective. So this is, I guess, Telix's strategy on a page, and it really summarizes what our plan is for 2025 and beyond. Actually, this is a condensation, really, of our three-year strategic roadmap. This year is an incredibly exciting year. We have three product launches, obviously subject to FDA, EMA. We have three product launches in the U.S. and two in Europe.
This is really expanding our commercial footprint from the three or four countries that we're in today out to well over 26 countries. Unlike many of our competitors, we're absolutely focused on, or absolutely committed to being a global player. You know, access to medicine is really important. We see that, to run global clinical trials is a necessity in this space, you know, given the competition for patients as well. Our pipeline on the therapeutic side is generally quite late stage. I'm going to give a breakdown of it in a minute. We have one phase three trial running right now in prostate cancer, our PROSTACT Global trial, and we expect to have two other assets in pivotal trials before the end of this year. So really underpinning the late-stage nature of our pipeline. Like many companies in this space, we are certainly interested in next-generation isotopes.
Now, I'll caveat that. When I show you our pipeline slides, you'll notice that we dabble in a very wide range of isotopes. That's because, as a company, we don't actually believe in the clinical utility of platforms. We think that, radiobiology and cancer biology in general is incredibly diverse, and you should choose the isotope that best meets the need of the clinical problem that you're trying to solve. And that's obviously a complex equation, but we take a pretty isotope-agnostic approach. But like many companies, we're excited about alpha emitters. We have built now an in-house, discovery capability that's also been augmented by some recent acquisitions that we've made. And so we feel that we're well-positioned to build, you know, a very strong pipeline for the future. And then I think I've already touched on the manufacturing piece, which is, you know, fairly self-explanatory.
Although I do want to note that the ultimate goal of having our own manufacturing and supply chain capability is not to usurp partnerships. Okay? Partnership strategies are super important. We value the manufacturing and distribution partnerships we have globally and particularly in the U.S. But it's about making sure that no matter what, we have the ability to deliver a dose to a patient because, you know, these are very mission-critical patients that we're, you know, we're impacting the lives of. So to put this opportunity in this sort of clearer perspective, you know, these are just three of our larger, more commercially relevant disease segments that we service. These are products for which the diagnostic is already, or the precision medicine component of the business is already well-baked. You know, that we have either product approved or product that's been submitted for regulatory approval.
And then we're sort of one stage behind on the development from a therapy perspective. And I think it's important to note that while the value creation potential of the therapeutic business is very high, the precision medicine piece is really important. And in fact, we won't achieve these inflection points commercially for the therapeutics business without the precision medicine business coming in before. It paves the way for the customer relationships. It defines the supply chain. It really validates the go-to-market strategy for the therapeutics. So they're incredibly entwined from a financial performance perspective. So that's a good segue. I'm going to talk, first of all, about our therapeutics pipeline briefly and then go into, I'm not going to cover every asset because I think that would bore everybody in the room to death and would exceed the time limits that I have.
But I'm going to go into a few key core programs and then a couple of our recent asset purchases that I think are exciting. Then I'm going to go briefly into where we stand with the precision medicine business and then wrap up with a tiny little bit on manufacturing and verticalization. My clicker is a little finicky. All right, there we go. So just at a high-level strategy and again focusing on those three core disease areas of prostate, renal, and glioblastoma, our current pipeline is mostly focused on beta-emitting radionuclides. We, you know, we're generally treating patients with bulky late-stage cancers. This is a place where beta-emitters do particularly well. We do see patient responses with alpha, but they tend to be not as durable because the path length of irradiation is shorter.
So we think that either beta or a combination of beta and alpha is going to be necessary to really durably treat patients in that patient population. So phase three for prostate and then the other are in phase two. A little bit controversially, we have decided to progress a bone palliation agent. One of the things that is sort of a new phenomenon in nuclear medicine is actually an appetite to prescribe radiopharmaceuticals. You know, we've had a big drought in the appetite to provide access to radiopharmaceuticals and, of course, with the success of Pluvicto and to some extent Xofigo, we're seeing that appetite. But of course, those therapies are not curative therapies. All patients progress. And when they progress, their clinical symptom is osteoblastic bone pain. And we now live in a post-Sackler-Purdue era of opioid compliance, which is very expensive.
This is new, right? So now all of a sudden, you ask the question, where's my nuclear medicine bone palliation? And the answer is we've lost it. We no longer have that ability commercially. So we're committed to developing a next-generation product to fill that gap. So these are the near-term assets that we have. And then that next-generation platform that I talked about earlier is predominantly focused on alpha-emitters. In some cases, they're follow-on products that are designed to move up the disease continuum into earlier-stage disease. So prostate cancer patients closer to their biochemical recurrence. I have a great hope that one day we'll actually take radiopharmaceuticals even into the castrate-sensitive environment because there's amazing synergies with androgen deprivation and radiation. So I think we can do a lot there, but we have some other targets that we're interested in in that pipeline as well.
Particularly, I want to call out our program in soft tissue sarcoma, which I think is a great fit for that platform, so this is our late-stage pipeline. I think I've talked about most of it and inferred most of it in my slides so far. I think I just want to draw you to kind of three pieces of information to digest, aside from the fact that there's a bunch of pretty near-term catalysts around each of those programs. The first is that, as I said before, we are isotope-agnostic, so you know, we think that's a strength of our company. When we go out and talk to the bigger guys that are just starting to think about radiopharma, we don't force them to pick and choose a platform. We're there to explore the entirety of the space of radiobiology, which we have extremely deep domain knowledge in.
The second thing is that we are targeting agent-agnostic, so we've got about 300 people in our development team. We are capable of developing both small molecules, peptides, as well as biologics, including engineered biologics, and we think that if you're going to solve important clinical problems with radiopharmaceuticals, you need to be able to select an agent that's also relevant to the pharmacology of what you want to achieve, the bulk of disease, the clearance organ that you may want to work with, you know, there's all kinds of considerations. Sometimes a small molecule will be better, you know, if you want to cross a blood-brain barrier, sometimes if you want to really have an excellent internalization and residualization, antibody receptor-mediated radiation delivery may be better, and of course, we're always trying to manage the off-target effects in a given clinical application as well.
So we think that's a particular strength of the company that we are able to develop across different modalities. Then you can see the concentration that we have from a clinical perspective in that urology, neurooncology, and then musculoskeletal space. We think that those three disease areas are particularly suitable for radiopharmaceuticals. In some cases, we're drawing on legacy understanding of radiation, including, by the way, traditional radiation oncology. You know, there's a lot of lessons to be learned from, you know, a century-plus now of experience in external beam radiation. Not all of it translates into internal radiation delivery, but some of it does. And certainly we can use that to inform clinical focus areas. This is our early-stage pipeline. Again, I've covered most of this, but just to note that we're augmenting our traditional focus areas in urologic oncology of prostate and renal with bladder.
We've got now a clinical stage program in bladder cancer, with the FAP assets that we recently acquired. And, I mentioned already the sarcoma program, which is based on a really outstanding antibody that we licensed from Lilly a couple of years ago that's now in the clinic doing dosimetry studies. So I think we have the deepest pipeline of alpha-emitters. I'm not aware of any other company that's got a deeper pipeline than we do. That's in late, you know, late preclinical, early clinical development. Three of these programs are in the clinic and will produce data this year. So it's going to be an exciting year for our early-stage programs as well. Okay, so jumping now into individual assets.
So I'm going to quickly touch on those three core assets: the prostate, renal, and brain, and then two of the more interesting recent ones that we're working on. Our PROSTACT, a PROSTACT Global trial probably needs no introduction to most of you. This is an in-progress phase three trial right now. These images are actually from another study that we read out last year. It really shows the differentiation of this product. Just, I mean, images tell a thousand words or two thousand words or whatever the moniker is. So what you can see here, first of all, is extremely long retention and residualization of Lutetium. This is a big difference between biologic-delivered activity and a small molecule. If you know, if you SPECT image a patient with a small molecule PSMA agent, you'll find very little residual activity a couple of days out.
And what that does is it gives us sustained and prolonged irradiation of the tumor. And that's what we believe contributes to the potentially better overall survival impact of these agents. Second thing you'll see is that, we have no lacrimal gland or salivary gland uptake. This is a big quality of life issue for the current generation of PSMA agents. If any of you have had xerostomia, maybe there's a couple of Long COVID people in the room. It's a horrible thing. And it absolutely does make a difference. And we downplay it. And we think it's not important, but it is. And that's something that we're very pleased to deliver to the patient. But the most important thing about this agent is that it's got a very condensed dosing schedule. It's two shots 14 days apart. And then the patient goes back to medical oncology.
And what we believe with the current generation of small molecule PSMA agents is that they aren't going to translate well into earlier lines of treatment because a medical oncologist is not going to hand over a patient to nuclear medicine for 40 weeks of therapy. They're just not going to do it. They'll never get the patient back. And so we have to, as an industry, as a nuclear medicine field, we have to come up with products that integrate well with the standard of care. Otherwise, they won't get used. And we saw it with Xofigo. We're going to see it with current generation PSMA agents. And so I think that that's a strategically important consideration. Yeah, so we're really excited about the study. We've got some data readouts this year. We should have around a mid-year readout on the first part of the study.
And you know, the KOL interest in this study, which is currently recruiting in APAC and the US. We expect to add European and Japanese patients later this year and perhaps a few other territories as well. So, yeah, really exciting study and look forward to keeping you informed of its progress. Our clear cell renal cancer program. So, the neat thing about this program is we use the same targeting agent for both, the imaging agent and the therapeutic. The imaging agent, the BLA, was submitted just before Christmas. And so what this does is it gives us an incredible interrogation tool for biology. And we have a number of phase two trials running right now, in combination with checkpoint inhibitors. We have a trial with Merck on DNA-PK where we're, you know, looking to kind of radiosensitize a patient to radiation.
It's a very promising approach where we can lower radiation doses and get equivalent efficacy. But the thing that I'm most excited about is that, you know, our imaging agent will pave the way for the usage of this therapy in clear cell renal cancer, but the target, carbonic anhydrase IX, is really a very much a pan-cancer target, and particularly in VHL cancers where there's a genotype to phenotype relationship for the expression of carbonic anhydrase IX. So there's a lot of patients, in that definition, with big unmet medical need. So you can see there's a kind of a vanity gallery there of images across a whole bunch of different cancers. You know, we've probably looked at a dozen cancers with this target. So we think that, you know, we're going to move this asset into pivotal trials this year.
That's our expectation, of course, subject to regulatory agreement, but we also see a long, you know, potential to move this into other areas of unmet need in the future as well. And I think that because of the strength of the imaging, you know, particularly for our CA9 program and our FAP program, there's really the potential to run basket trials where we can do image-based patient selection. And what I would love to see happen for radiopharma is that we start to run trials where the selection criteria is based on target expression by imaging and to be solid tumor agnostic. I think if we could achieve that, you know, that's a game changer. And then frankly, that's how we use radiation oncology today. You know, we do an FDG scan. We look at the tumor.
We define some tumor treating fields, and then we zap the patient, so we should be doing that with radiotherapeutic approaches as well. I've mentioned already our GBM program. It's a big area of unmet need. We have preliminary data that suggests that we confer a survival benefit on patients. Certainly, we've seen evidence of antitumor response from imaging. We see good disease stabilization. That means that patients are not on steroids. They have a prolonged period of disease stabilization. We've run two studies already, plus a cohort expansion in the refractory GBM setting. We think we have enough safety data, including combination safety data with temozolomide for the frontline setting, to be able to progress this into pivotal trials, and in fact, we had a pre-IND meeting with the FDA before Christmas where they expressed quite a bit of enthusiasm for our proposed study design.
So I'm excited to move this towards late-stage trials and, you know, potentially pivotal trials in 2025 as well. Okay, so that's the core sort of three assets. And we have many other programs, but the two that I thought I'd touch a little bit more on. I mentioned our palliative care agent. I think I've kind of given you already the rationale for this. We think this is something that can go pretty fast. It's based on a well-known mechanism of action. Samarium-153 is an isotope that's well understood, but historical products had issues with supply chain and toxicity and impurities that were longer half-life impurities. And we resolved that issue from an isotope processing perspective.
And so what this product does in terms of its target product profile, it's one shot and it gives you four months of pain relief in osteoblastic bone pain patients. So those are the vast majority of prostate cancer patients and 20%-30% of breast cancer and lung cancer and colorectal cancer patients. We have imaging tools that can also be used to select patients for this in you know in other cancers. So I think that there's really the potential to move this along in a rapid fashion. And there's a very, very big unmet need. But I think from a commercial strategy perspective, what this does is it gives us an entry point for our commercial team to start delivering a you know a therapeutic modality into our customer base, which I think is super exciting.
And then the FAP program, we licensed this late last year. It's a very desirable target right now in radiopharma. It's got a lot of traction. The problem is that the vast majority of assets to date haven't really demonstrated any therapeutic index, even though the target is interesting. That's not the case for this. It has an excellent tumor retention time. We've got data in about 500 patients with imaging, 300 patients treated, about a third lutetium, a third actinium, and a third yttrium-90. And so we're learning some really interesting things about how to irradiate the stromal fraction of a tumor for therapeutic efficacy.
And I look forward to, you know, to roadmapping this asset a little bit over the next 12 months and, you know, getting this into late-stage trials as quickly as possible, frankly, given the very large amount of clinical data that we have for this asset. Okay, so that's the therapeutic rundown. I'm just going to very quickly spend a few minutes on our precision medicine business because it is the revenue generator for the company as well as the market entry point for these therapeutic assets. I think our strategy is pretty self-explanatory. Multi-product, multi-jurisdiction, build that revenue stream, you know, as quickly as we can. Global expansion, as I already said, is a big part of the goal this year. We do have a phase three trial that's just finishing recruitment in China.
We've got a bridging study phase three trial that's just been agreed with the PMDA. Japan's actually a pretty healthy market for our imaging products. So we're excited to build relationships with the regulators in some of these other countries. And by the way, one of the, you know, benefits of being globally, kind of available is that we support a lot of clinical trials from big pharma. So unlike our competitors, we don't necessarily put a PowerPoint slide out dedicated to it, but we do, in fact, support a very large number of clinical trials because we can deliver PSMA imaging globally. So we're really learning a lot from that process, particularly how do imaging agents longitudinally get used in treatment management.
And then things like artificial intelligence and building tools to help streamline and automate clinical workflows. That's something that we think can also help us to build market share. So that's really our kind of high-level strategy. We've got new product approvals this year, a lifecycle management product for Illuccix called Gozelix. So expect to see lots of Japanese dinosaur monikers and stuff like that coming down the pathway. But we've got a, you know, we're the first company that's come out with a second-generation PSMA agent that has really profound clinical implications as well as differentiates us from a reimbursement landscape perspective, which, as most of you know, has become quite complicated, although improving, in our space. So Gozelix has a PDUFA of March. Pixclara, our GBM product, has a PDUFA of April.
And then we haven't been given guidance yet on Zircaix, but we're expecting it around the August-September timeline. So, you know, three product launches this year, building on the success we've already had with Illuccix. We're not lying down on clinical indication expansion. This is just a snapshot. The blue bubbles are things that we already have on our label for PSMA imaging today for Illuccix. We've got a wonderful track record in working with luminary academic centers. We're exploring a whole range of indications, many of which we expect to be label expanding. We're even exploring the use of PSMA imaging outside of prostate cancer. So, you know, we're in it for the long run. We want to be the category leader in this modality, and we really have a clear vision clinically about how we're going to achieve that.
And so just to wrap up on the prostate side, you know, we're focused on patient access. We're lifecycle managing our products. We're really looking at what's required to make this modality successful for the clinician. And we really expect in 2025 and 2026 to grow our market share considerably, because we've just got a better competitive strategy. Our renal cancer product had its data published last year in Lancet Oncology, which was, you know, a great win for the company. We demonstrated excellent sensitivity and specificity. This is the first imaging agent that's actually phenotyping a cancer. So it's not renal cancer. It's clear cell renal cell carcinoma, which is really what you want to know. It's the most aggressive form of cancer, of renal cancer. You want to know that that's what the patient's got.
We demonstrated an ability to detect lesions as small as a couple of millimeters. It has localized staging implications. It has metastatic implications. It's a very large number of patient scans. So, you know, this is a, a product that's going to be, you know, super exciting to launch this year and has excellent clinical data backing it up. And then, while I've talked about our GBM therapy program, we have an imaging agent that targets the same target, LAT1. It's got a PDUFA goal date, as I said, of April. This really paves the way for a theranostic strategy in glioblastoma. We really believe that as we look at the clinical development strategy that we have in glioblastoma, that the imaging agent's really going to accelerate the therapy program. So again, a great example of how really bringing the pieces together and doing theranostic medicine is important.
I think one exciting thing about this asset as well is that we're already written into practice guidelines, so that the barrier to adoption of this agent is really, is really very low. There's a ton of excitement about this being finally available in the United States because it's, it's actually pretty much standard of care in the rest of the world. Okay, last of all, and just before we wrap up, to a couple of questions to the floor, two slides on manufacturing. So, you know, this is a key part of our strategy, as I said in my opening comments. We take a partnership-based approach. So, you know, we're really grateful to work with outstanding organizations like Cardinal Health in the United States. You know, this is key to being successful in the U.S. market.
But there's a lot of expertise and a lot of intellectual property in knowing how to scale your products. And that's why we've invested, you know, $400 million over the last two years to really build the infrastructure globally for our products. And you can see some of the areas, I won't go through them individually in that pie that we've focused on. You know, we're not going to do everything in manufacturing. We obviously don't make APIs or antibodies. It's about the radio-labeled hot product. But the number one goal is to be able to go that last mile and to make sure that, you know, when we say we have a product, we can deliver it. I think you've all seen how the radiopharma industry has struggled. Even the big guys have struggled to deliver on that promise.
So we, you know, we want to make sure that we make good on that promise to patients. I mentioned partnerships. In some territories in APAC and in North America and in Europe, we have a high degree of self-sufficiency or very integrated partnerships, as I've already mentioned, in some parts of the world in Latin America and greater China, for example. We do work with distribution partners or joint venture partners to do localized manufacturing and market access. You know, we've built a very capable platform with a reach into a lot of countries. The U.S. is special. As I've mentioned, we do have partnerships, but we also have the ability to deliver products through our own nuclear pharmacy network. We agreed to acquire RLS late last year. This is the former GE Nuclear Medicine Nuclear Pharmacy Network.
We joke this is an NFL network. Any city where there's an NFL team, there's an RLS pharmacy. So this is about major metropolitan coverage, and then when we combine that with the cyclotron technologies business that we bought last year, a Canadian company, it means that we have enormous reach, out of those 35, you know, 34, 35 nuclear pharmacies, across the United States. This is really about springboarding distribution for the next generation of products in the company and really making sure that we have that vertical integration. So, yeah, it's an exciting development for the company, and I think it really stands the company apart. So, you know, what do we get out of all of this, organic and inorganic growth? I think the most important thing is, you know, we're about 1,100 people now globally, you know, 750 of them in the U.S.
We have an incredible R&D platform and ability really to reach the patient. And I think it's that talent and expertise that we've built over the last couple of years that really sets the company apart. Okay, so just to wrap up, I think hopefully I've convinced you that 2025 and beyond is an exciting time for Telix, commercial growth, expansion of our pipeline, and delivering on our therapeutic development milestones. You know, we have a ton going on inside the company. And again, with that singular focus on how do we make sure that we deliver to patients every single day. And just to leave you with, I'm not going to go through, I promise, each one of these bubbles, but these are the catalysts that we have coming up in 2025. So an awful lot going on in the first half of the year.
Lots of things to talk about and sustain news flow, and particularly those product approvals and therapeutic development milestones. Then I've, you know, left a few things there, to sort of tantalize you of what's coming in the second half of the year as well. It's not exhaustive, but it was all I could fit onto the PowerPoint slide. So that's what you, that's what you get at the end. So, you know, thank you for your time. And I'll take a question or two if there's one available.
Thank you, Chris. I mean, that was very comprehensive as usual. Look, I do have a question online, and if there are any questions in the audience, there is a microphone available. So let's start with online. Could you discuss the strategic rationale and implications going into the radiopharmacy market segment through the acquisition of RLS?
I think I've more or less covered that. You know, you got to be able to guarantee delivery. You know, one of the things that we think is missing right now in the nuclear pharmacy manufacturing space is a focus on radio metals. Historically, most of that manufacturing infrastructure is focused on either SPECT products or legacy nuclear medicine products or F18-based cyclotron products, which you know you're familiar with from our competitors. We think that if we can take PET products into SPECT nuclear pharmacies, we can deliver products in a very cost-effective fashion because we're not doing GMP manufacturing of unit doses. We're dispensing doses under practice of pharmacy, and the cost base is very different. We're also, with running a network like RLS and our key partner networks, not doing centralized manufacturing.
We're not prone to batch failures. We don't have to maintain cyclotrons. We, you know, as our commercial team likes to joke, we're locally farmed to scanner. And that's a big strength, you know, in the radiopharma space. So we decided to make that investment really for the long-term, you know, product portfolio and future of the company. And obviously, the U.S. market's critically important in terms of patient access. Thank you. All right, one for me then. So looking into 2025 and being aware that you haven't given guidance, there were some quite material changes to CMS funding late in the year. Could you talk through what the implications are for the business going into 25 and how it sets you up versus the competition? Yeah, basically, it was great, a great outcome for the whole industry.
You know, CMS has now, you know, defined a pathway for reimbursement post-transitional pass-through approval, which was a really good innovation, that, you know, led to a lot of dynamism in the imaging business, but also created a little bit of an expectation cliff once pass-through was over. So now we have a pricing strategy based on a more conventional MUC pricing. It provides a lot of clarity around how product is going to be reimbursed and then made available to patients. We still have, unlike our competition, six more months of pass-through, which is, you know, puts us in a very commercially advantageous situation.
Also with our PDUFA date for Gozelix in March, it means that we expect to seamlessly transition from one pass-through product to another pass-through product, because we think that in the particularly the large academic segments, you know, the HOPPS accounts, that, you know, there'll be a preference for, you know, a reimbursed product. It really gives us a commercial advantage. And of course, one of the consequences of being on a non-pass-through payment structure is that your patient is going to have to come up with, in many instances, not all instances, but many instances, a copay, you know, 20% copay, which is going to be, you know, $1,000 out of pocket. So, you know, we think that for, from a patient benefit perspective, we also land in a, in a really good place.
So the combination of where we stand, we, you know, we have a clinical differentiation. We have the best sensitivity and specificity. We have the best inter-reader variability. We have the lowest false positive rate of all the PSMA agents. We have a distribution structure which is very reliable and really valued by our customers. And now we have a pretty significant tailwind from a reimbursement perspective. So CMS was pretty good to us this year. And just to clarify, I mean, where would you say the market share is for Telix at the moment in the PSMA space? Yeah, there are a couple of underreported parts of the market, but we're sitting somewhere around the 35% market share. You know, we chip a couple percent off our competition every quarter, and we expect that trend to continue.
The PSMA market by itself is also, you know, it's got a fair bit of organic growth in it still. You know, it certainly all boats, you know, rise in the tide. And then with the prospect of us coming out this year with Zircaix, which is targeted at the same referral physician as Illuccix and Gozelix, we have a trifecta of products that we could really go out and talk to the same, the same customer about. And, and we, we, you know, you shouldn't underestimate that cross-sell value of the really great established relationship we have with urologists and, and, and radiology and nuclear medicine. To be able to go and, and talk about a portfolio is really powerful from a, from a selling perspective. So our, our, our commercial team is really excited about what this year has got on offer.
Great.
Look, I've got one more in the last minute or so that we have. I mean, Chris, you talked about spending $400 million over the last couple of years on the infrastructure. You know, are we done? I mean, do you have the infrastructure that you need in place?
We invested, not spent, but yeah, absolutely. I think we've made really good inroads. I don't, you know, there are some things that we will continue to do from a capital investment perspective. This year, we're going to be installing a bunch of cyclotrons in the U.S. market. We've got clean room expansion plans in our Belgium facility, which is to service the European market. But I think in terms of the bigger ticket acquisitions, I think we've made really solid progress.
And, you know, now, now we've got to digest what we've eaten, I think would be a good way to describe it.
Perfect. Look, I think we are just about at time. So, Chris, thanks very much. That was a comprehensive presentation.
Thanks.
Thanks.