We'll have some important FDA meetings.
Okay.
Okay, good morning. Thanks for joining us here at the J.P. Morgan Healthcare Conference. My name is Chris Cooper. I cover Australian healthcare here at J.P. Morgan. For this session, we're very fortunate to be joined by Christian Behrenbruch, the CEO of Telix. Christian will speak for about 20 minutes or so, and we should have some time for Q&A at the end.
Great. Well, thanks very much, Chris, and to the J.P. Morgan team for the opportunity to present just the customary disclaimers and forward-looking statements. So, for those of you who don't know, we're an increasingly well-known company in the radiopharma space, and there's a lot of folks that are starting to take interest in the company and its commercial trajectory. We're a fairly vertically integrated radiopharma company specializing in oncology. We are solely focused on radiopharmaceuticals. We have a very much precision medicine-oriented approach in the way in which we think about radiopharma. A lot of new companies have emerged in recent years that are focused really just on the therapeutic aspects of radiopharmaceuticals.
But if you think about what you get when you develop a radiopharmaceutical, you get a signal with every dose that you put into a patient, and that signal's extremely valuable in terms of understanding the efficacy and the targeting, the delivery of your payload. So, for every target that we develop as a company, we develop both an imaging agent and a therapeutic. And this has actually served the company well from a commercial strategy perspective because we've been able to monetize that precision medicine business early in the company's life. So, we are a commercial-stage company. We've built a very capable commercial team. In fact, I think it's one of the great assets of the company. And certainly, from a commercial execution perspective, the last 12 months have been very successful for the company. I'm going to go into a bit of detail on our therapeutics pipeline.
That's going to be more so the focus of this presentation. A little bit on our new capabilities around basic R&D. When we founded the company almost a decade ago, we didn't really have the appetite to do discovery or new asset development internally, but we now see that there's an opportunity for us in some key areas, and I'm going to give you a bit of insight into that as well. And then, last of all, one of the things that differentiates Telix very much from other companies is the commitment and the investment that we've made. We've invested about $500 million in the last two years on manufacturing, supply chain, and distribution capabilities. We own a nuclear pharmacy network in the United States, which we think is very important to future distribution of therapeutic radiopharmaceuticals. And that vertical integration really sets us apart from competing organizations.
It's a very full story. Our lead commercial product is in the prostate cancer space. Actually, we have two products: Illuccix and Gazelix. Gazelix is a life cycle management product for Illuccix. It's been a very successful product launch. We are now in 2025 with an extremely busy year for the company. We expanded into 17 other countries outside of the United States, including Europe and the U.K., and also we have an approval in Brazil. We filed an NDA now in China, and we have a phase three study, active bridging study in Japan, which we'll complete this year as well. Really, our goal as a company, and again, it's a little bit different than some of our peers, is to really be globally active. We think that that's important. And again, the precision medicine paves the way for a therapeutic presence in these countries.
As we look more and more at clinical practice guidelines, patient selection and patient stratification through imaging is how we deploy radioligand therapy. And so, having that footprint in these other countries is not just about generating some early and important revenue streams for the company, but they're also about establishing that physician presence and that customer relationship. Illuccix was a great success for us last year, so that we got a new drug approval back in April of last year. We got pass-through for this product, which became effective 1st of October. So, our last, this past quarter was our product launch quarter. We had a really nice quarter. We'll be putting out our financials next week, around the middle of the week, and you'll be able to see what the impact of that is.
But again, this is a life cycle management with some really nice differentiation in terms of how we deploy the product, how we are able to reach patients that are perhaps further away from major metropolitan areas, but also much larger capacity production really into the hands of those academic centers using our cyclotron technology capabilities. And I'll maybe talk a bit more about that later on. Financially, this is a snapshot of the company's growth over the last five years since we became a commercial-stage company. I really do think that the commercial execution is something that we've done extremely well. Our guidance for the full financial year is in the $800 million-$820 million range. We expect to see this growth trajectory to continue over the next, really over the next two to three years. It's not just about our prostate cancer imaging franchise.
It's really about how we have layered in multiple products that are coming online very soon that are targeted at really building that deeper relationship with specific referral physicians that we have a strong level of traction with, particularly in urologic oncology. I'll talk a little bit more about that. We also, through our radiopharmacy business, have a certain amount of third-party revenue. We've actually continued to grow dose volume really nicely in that part of the business over the last 12 months. It's been a successful acquisition, although quite demanding on the organization. We went from about 350 people at the start of last year to almost 1,200 people at the end of the year. We introduced a lot of capability, but we also organizationally matured a lot last year.
I would say that with some of the setbacks that we had last year, which are reflected in our market cap, we really went back, we re-engineered the bench strength in our development teams. I think we really augmented our capabilities. I feel that 2025 was a bedrock year that we can really build on in a very promising way in 2026. In terms of growing the commercial near-term revenue-generating part of the business, there are sort of three parts to the strategy. Pixclara and Zircaix, NDA and BLA resubmissions are proceeding as we expect them to. Pixclara will be submitted very shortly. Zircaix is well on its way. We've got one more FDA meeting coming up, and then that will follow Pixclara. We've generally had a very high degree of engagement with the agency, so I feel like those resubmissions are in good hands.
And we do expect to launch those products in 2026, obviously subject to regulatory approvals in the United States. We do have plans, of course, to expand other geographies as well as we did with Illuccix. The 2025 for Illuccix was really about getting those marketing authorizations and getting reimbursement moving outside of the United States. We expect to see the financial contribution of that in 2026, or at least it start to happen. And as I said, we do have a plan for follow-on registration for Pixclara and Zircaix as well outside of the U.S. That's very much in play right now. The other thing that we're working on is really expanding the indications in our existing prostate cancer franchise. So, prior to Christmas, we launched the bypass biopsy study, which I'll talk a little bit more in a second.
This is really a game-changing indication expansion for prostate cancer that we think will significantly increase the total addressable market for Illuccix and Gazelix. And again, it's part of our longer-term growth strategy as a company. The PSMA market itself has a lot of headroom. We see today that it's about a $3 billion TAM. We're a significant player in this. We have now doubled down in terms of our presence in this market segment with Gazelix. We see opportunities just through practice guidelines and continued clinical adoption to expand the market. We see bypass as a potential part of that. And then we have a long-term life cycle management commitment. So, we have several other follow-on products.
I think it's now accepted in the industry that, like other parts of pharma, that regular life cycle management of these diagnostic imaging products are going to be important for maintaining commercial leadership. And we have a very clear game plan for how we're going to do that, including picking up some capability in the fluorinated PSMA space. We have a phase 3 study that will launch this year based on a very novel approach to flexibly radiolabeling PSMA-11 with either gallium or F18. There's a physician choice there. We're happy to serve that choice in a flexible and differentiated way. I did mention the bypass biopsy study. So, this is really about going upstream from the current label space that we have in prostate cancer imaging.
The majority of patients are either pre-prostatectomy high-risk patients, where you're looking for extrapelvic metastases, or patients that have reoccurred following a definitive intervention and have a rising PSA. We believe that biopsy is something that can be optimized. We're not looking to eliminate biopsy. What we're looking to do is to make sure that when a patient gets biopsied, that they are the right patient for a biopsy. There's more than a million biopsies that are performed in the U.S. every year. Really, only about 20% or 30% of those are actually beneficial to a patient. So, if we can triage that, that's very powerful. It's got a clear pharmacoeconomic benefit in terms of patient impact and diagnostic impact. But what it also does is it positions us very much at the front of the queue.
We're going to be there at the beginning of that patient journey, and it puts us in a position to repeatedly serve that patient over their prostate cancer journey over the course of their life. And I think that's not just a clinical advantage. That's a commercial advantage as well. So, this is a phase 3 trial. It took us about a year to get it over the line with the FDA. These kind of very early-stage intervention-driven studies are extremely clinically challenging to get launched and a high degree of regulator buy-in to get a label-forming study over the line. We've now done that. It's actively recruiting internationally and in the United States. So, I'm really excited and recruiting very fast. This is going to be a very quick study for us to get done.
Just maybe a little bit of comment and build on my earlier comments about scaling globally. Really, over the last three, four years, we've built a pretty impressive international footprint in terms of our ability to deliver product. This is not just for diagnostic products. This is for therapeutic products. So, this includes GMP manufacturing capabilities in the United States and Europe, and we're increasingly building capabilities in other parts of the world as well. We just opened our first production center in Japan, which is a commercially important market for these products late last year, and we have a couple of key partnership relationships as well in Latin America, where we do manufacturing in a joint venture, and also in China, where we have a regional strategic partner, so very active global footprint.
Part of the investment that we made in buying radiopharmacy infrastructure was really to acquire that step change and scale function for the company. We delivered 150,000 Illuccix doses and Gazelix doses last year in the United States, either through our own pharmacy network or with key partners, long-term partners like Cardinal Health. In totality, the group delivered about 2.9 million doses to patients last year across all of our operating segments. This is really about building a foundation for long-term volume growth and delivery to our patients. So, I think the commercial execution and the manufacturing and supply chain execution for the company has been very strong and is getting stronger every single day. In terms of the investment strategy, so it's useful to think of the company really in terms of kind of three epochs.
2025 was a transitional year for us where we really started that large-scale reinvestment phase for the company, which is this sort of middle period. We had our initial commercialization, our first product approvals. Now it's really about diversifying that revenue stream through multi-product and regional expansion. But the goal between now and the end of 2027 is not an earnings-oriented goal. The goal is to really take the revenue that we generate from our commercial business and maximally reinvest it into pipeline and infrastructure. And we're very blessed. I mean, we're abutting up to $1 billion in revenue. We expect to significantly exceed that over the next couple of years. It gives us enormous earnings capacity in a non-dilutive way to reinvest in the business. And we're doing that extremely assertively. So, we're trying to set expectations with investors and analysts. This isn't an EPS story.
Even though we are classified as a healthcare company, a lot of people see us as a healthcare company, we're really a self-funded biotech company that's doubling down and tripling down on our pipeline and our supply chain capability, so the next two years are going to be really exciting in terms of building that infrastructure, building out that pipeline, and we have three therapeutic programs that are in phase three, pivotal late-stage trials this year. That starts to build a ton of value creation for shareholders as we get new data points come out. Once we get into 2028, that's where we expect to see our investment needs outstripped by earnings, and then I think maybe we'll look more like a regular healthcare company at that point in time, but right now, think of us as a self-funded biotech company.
I think that's a very powerful position to be in, given the market dynamics that we experience. I did mention in my opening comments as well a little bit about our interest in being a little bit more of an in-house innovator. This was something, speaking as the founder CEO of the company, I was never really that keen to do. I felt that there was lots of great innovation being done in academia and small companies. We can be a channel partner and a go-to-market partner for that. But what we're seeing now is the emergence of all kinds of exciting new isotopes, and if you look at the products, I like to think of them as first-generation radiopharmaceutical products that are out there. They're either very unoptimized small molecules or they're somewhat unoptimized macromolecules.
Actually, as we see things like lead-212 and actinium and astatine come forward, there's a real desire to match the pharmacology of those targeting agents with the half-life of those isotopes to build products that have better efficacy, better patient tolerability. So, we've decided that alongside in-house isotope research and cyclotron technology development capabilities, that we are also going to develop a biologic-centric innovation capability to look at some of these formats that are in the middle of the PK spectrum, where they're hours to day, blood half-life, where they match very, very well onto some of these next generation of radionuclides that are coming down the pathway. We've got two really exciting programs, one in DLL3 and one in alpha v beta 6, an integrin-binding domain, which are getting ready to go into the clinic.
So, by the end of this year, they should be ready to go into first-in-human studies with alpha emitters ostensibly. Okay. So, just as a wrap-up, before I go into a couple of snapshots, I'm not going to go exhaustively through our pipeline, but just to spend five minutes or so going through some key examples. This is our late-stage therapeutic or our clinical-stage therapeutic pipeline. So, this does not include a number of assets that we are developing preclinically. So, everything that you see on this list is being administered into patients today or has an IND approval to go ahead. So, it's a pretty substantial pipeline of assets. Notably, our TLX-591 prostate cancer therapy is in phase three. We've completed a running study, which we'll read out very, very shortly.
are already recruiting in the U.S., the part two of that study, so the randomized portion of that study. We also have a go-ahead for putting our carbonic anhydrase IX program into a phase three study, as well as our iodine-131-based glioblastoma agent, which has shown some promising efficacy. I'll go into a little bit more detail on that in a second. I think just as a general comment about our pipeline, one of the things that you'll notice is that we are not a platform technology based on a single radionuclide. That's not how cancer works. We don't think that's how radiopharmaceuticals will be developed. We think that it's really important to choose the right isotope for the right application. It has to be aligned with the biological problem that you're trying to solve.
And so, that's one of the reasons why we have invested and built such a strong in-house capability on the basic radioisotope and isotope sciences part of the business to be able to facilitate that diversity of decisions around our isotopes. Okay. So, very quickly, just a couple of key snapshots. I'm not going to go exhaustively through the whole pipeline. As I mentioned, our 591 asset, which is an antibody-directed PSMA therapy or radio ADC, as we like to call it, we have completed a running study, which was something that we agreed with the FDA as part of our new manufacturing package. And we have part two, which is the randomized segment of that study is already recruiting in a bunch of countries outside the United States: Australia, Canada, U.K., Turkey, Singapore. There's a whole raft of seven or eight countries that are already recruiting.
We are shortly going to be disclosing the part one of that study, although I note that a data safety review has already taken place of part one to enable part two to move ahead. So, we see this as a fairly straightforward process from a disclosure and an FDA engagement perspective, and that will happen in the very near term. We've seen historically really good data with this asset. It's highly differentiated. We inject a much smaller amount of radiation into the patient. We have a very condensed dosing schedule. That's two shots 14 days apart. We have a very differentiated clinical utilization in terms of we don't need specialist infrastructure. We don't need radioactive toilets. There's a lot of things about this asset that make it very nice to administer, and we get really positive feedback from the key opinion leaders that use it.
I'm excited to see a real push this year on completing that randomized part two and hopefully continue to get this sort of data that we've seen historically, which is very, very encouraging from a product differentiation perspective. Our follow-on program in alpha, TLX-592, we did a study with a proxy to actinium. What we have seen in other assets, for example, with the J&J KLK2 data, is that assets that have a long circulation time in the blood tend to have, and where you have highly perfused organs, like for example, the lungs, you tend to see adverse events with alphas. We wanted to make sure going into our first actinium program that we understood the biology and the pharmacophore that we're using very well.
We did an imaging study first, a non-therapeutic study to really look at biodistribution and to feel confident that we had something that was the right pharmacology to take into patients. It was very slow because it's an imaging study. It doesn't confer much patient benefit, but very enlightening. It enabled us to set mass dose. It enabled us to design our first-in-human study with actinium that has now received clearance to start clinical trials, and we're in the process of recruiting first patients into that study. I'm really looking forward to seeing that story evolve. It's our first true alpha program and very, very differentiated approach for targeting PSMA with an alpha emitter. We are looking holistically at our therapeutic landscape in prostate cancer. We are interested in earlier stage disease. We look at that through the lens of the alpha program.
We look at that through the lens of our collaboration, for example, with Varian and looking at how you do image-guided SBRT in early-stage patients. I think there's a real role there for the combination of external beam radiation and internal radiotherapy together, so that's something that we're really looking at. If you look at the ProstACT Global Trial , our phase 3 trial, it's a mixture of first-line and second-line castrate resistance, so it's in that sort of middle of the treatment journey, and then TLX-90 is really at that end-stage journey. We see a prescriber appetite for radiopharmaceuticals in advanced patients. The art of palliation in nuclear medicine has been somewhat lost because of successive product cannibalizations. There's an opportunity to go back in there and really reestablish nuclear medicine-based palliation, but with a next-generation product that has a lot better economics and a lot better patient safety profile.
This is a really exciting asset, and it has huge patient impacts. A lot of patients, a lot of prostate cancer patients that reach the end of their hormone therapy and their PARPs and their radioligand therapy, they don't have other treatment options. They go into palliation with a lot of pain. This is a really important opportunity to serve the patient going into that transition to palliation. So, we're getting our—this is basically a bridging study to a traditional samarium-based agent. It'll give us a good understanding of how we stack up against historical agents in this area. And again, that program is getting really nice momentum with key opinion leaders that are involved in the study. I mentioned in the beginning that one of our strategies is to really double down, and that's with a particular referral physician.
That's not just on the diagnostic imaging side, but also on the therapy side. So, we do have nice phase one and phase two data in clear cell renal cell carcinoma. We have the Lutyon trial now, which is up and running. It's a phase two-three trial. It's really about a fast run-in dose finalization into a phase three trial. That's a key execution focus for us this year with the new TLX focus on real clinical execution and timely clinical execution. So, we expect to really get good data momentum there in this program this year. We've seen nice examples of targeting. We've seen some really interesting patient examples where this asset has made an impact on patients. And so, we've got a lot of expectations that this program will yield good outcomes for the company over the next couple of years.
And then just very quickly, outside of uroncology, our IPAX Bright phase 3 trial has started. It's a pivotal trial. This is, again, an adaptive dose optimization leading into a primary label registrational study. It builds on what we've learned in the IPEX two study. So, we really have a clear understanding of the dose range that this thing works well at, very good understanding of the patient safety profile. We've seen excellent evidence of antitumor effect in the studies that have been performed to date, some of which has been published recently in peer-reviewed environments. So, it's really, again, a very exciting opportunity for the company that will generate quite a bit of momentum this year in terms of late-stage development. And then finally, just one other call-out as I'm running out of time. One last call-out is really our FAP program.
Part of what we did last year was not just invest in our supply chain, but also we augmented our pipeline in some key areas that we think are important for the future. FAP is clearly an interesting target. We think we have the absolute best pharmacophore in this space. We've got data in several hundred patients with lutetium and actinium and yttrium. So, we have a data set that we can really design late-stage trials around right now. We're at the stage where we're getting the CMC package together so that we have a very clear run at late-stage studies with this asset. It is a theranostic pair, so we are developing the imaging agent as well. So, really great opportunity and very much a pan-cancer indication.
I think one of the challenges that we'll have over the next couple of years is both FAP and CA-9 have applicability in a very wide range of cancers where we've seen clinical utility in a fairly wide range of cancers. We're going to have to be disciplined about how we prioritize some of those clinical indications, and that's some of the decision-making that we're going to have to make over the next 12 months, particularly for this asset. There's a lot of different directions that this could go, but however you rack and stack it, one of the things that I think I want to get across to you today is just the opportunity that we have in the business. So, not just on the precision medicine side of things. I mean, we're butting up against $1 billion of revenue. We see a clear pathway to surpass that.
There's a large addressable market there for our products that we can continue to take, but really also that future frontier of that therapeutics business. When you look at across all the different disease area franchise that we work in, it's a very substantial opportunity for the company. Without going into individual, and I might just leave this slide up as we go into Q&A, but this is what we have to look forward to in 2026. I particularly want to call out that the near-term readout on part one for TLX-591's Prostate Global and also the resubmission of Pixclara and Zircaix is proceeding as we expect, but so many other milestones to be hit this year, both on the therapeutic side and the precision medicine.
And it's not just the slide, the way it's written, but it's really in terms of how we think of the key catalysts for this year. It starts to reflect TLX moving much more with that therapeutic focus in mind. That's the prioritization of our investment. It's where we think a lot of the news flow will come out of this year. So, I think it's a very exciting year ahead and really builds on the bedrock that we created in 2025 for the company. So, I'll pause there. And Chris, over to you.
Thanks, Chris. Feel free to raise your hand if you have any questions in the room. Perhaps I'll start. So, perhaps at the top left of the slide there, Chris, the prostate therapeutic, I'll take imminent as weeks more likely than months.
Yeah, exactly.
Okay. And maybe then in terms of the part two sort of randomized enrollment, how quickly does that get up to speed? And I know you sort of still think this is going to be launching in the relatively near term.
It already is launched. We've got approval for part two, and it's recruiting in seven or eight countries. I mean.
In the U.S., sorry.
In the U.S., yes. So, well, that'll be subject to what the FDA says, but we've had no difficulties with non-U.S. regulators in terms of moving the study ahead. We view this as a discussion that has to take place and will hopefully result in U.S. patients being added to the study in fairly short order. But we've had no challenges in moving the study ahead with other sophisticated regulators. So, I think it's really just about hitting that milestone.
Yeah. Got it. Okay. Zircaix, so you mentioned a positive Type A meeting you had shortly before the end of the year. Now, you had to address some CMC deficiencies, which were raised in the CRL. Were there any other observations that had to be addressed as well? Are you following up separately on that issue? And maybe just an update on the timing of the resubmission.
Yeah. So, the whole span of topics that came through from the CRL are really all around manufacturing and comparability between our clinical and our commercial scale material. When we run clinical trials with radiopharma, we aren't typically using large commercial scale practices because you're dealing with large amounts of radioactivity. Radiopharma is still very much a small batch production or smallish batch production, continuous production type of environment just because you have a decaying product. So, we had a bit of extra work, and it's the first time that anyone's put a PET biologic in front of the FDA, and it was our first time and their first time. And I think we learned a little bit together. There were some things that we were surprised at that we've had to go back and fix, but they're not significantly adding to timelines or anything else like that.
We have an upcoming meeting with the FDA to look at the clinical comparability data that we have proposed or the clinical comparability strategy that we've proposed. When we filed the BLA, that was deemed not to be necessary by the FDA, that analytical comparability would be sufficient. But upon review of the package, they determined that they wanted to see clinical comparability. And so, that's where we've landed. Fortunately, we did a clinical comparability study, and we have an open study protocol that we anticipated perhaps European regulators wanting. So, we're in pretty good shape in terms of that package. And so, once the FDA tells us that they're happy or otherwise, we're in a good position to move ahead with that refiling.
Thank you. Any questions from the room at all? Yeah.
Thank you for the presentation. As we think about the next five to 10 years in terms of radiopharmaceuticals, what do you see as the biggest challenges for that market to really scale up both on the therapeutic side but also on the infrastructure, supply chain, etc.?
I think it is exactly that. I think it's the infrastructure and supply chain, but I mean, that is somewhat an investment-driven outcome. I mean, I think we see a lot of companies that are out with very novel radionuclides, even things like actinium, where there really isn't a commercial supply chain available. I'd say that lutetium has an established supply chain, but it's vulnerable. And vulnerable supply, I mean, even when you take something like technetium that we use 40 million times a year around the world, it's still a vulnerable supply chain. So, these are definitely challenging. I think that execution-wise, clinical execution-wise, the biggest issue is the lack of clinical infrastructure to support this. On the rare occasion that I lose sleep at night about this industry, it's the lack of techs. It's the lack of practitioners.
It's how do we get radiation oncology up to speed on these therapies? How do we make it easier for medical oncologists to integrate radioactive therapies into standard of care? How do we run clinical trials where we actually prioritize the integration of radioligand therapy with standard of care rather than the sort of traditional head-to-head approach that nuclear medicine favors? So, yeah, I guess the fundamental problem we have to solve is how do we make this class of drugs available to a more general prescriber base? And that's a really tough challenge to solve. But there's a lot of opportunities as well there for different types of organizations that will do things in a different way. Yeah. Anybody else have a question or comment? We still got a few minutes left, so. Well, maybe you'll have to throw one at me.
Pixclara, Chris, if you don't mind. So, you've got the NDA resubmission there on the top of your slide. I believe you said. I wrote it down. Very shortly would be the timing of this meeting.
Yeah. Well, we wanted to get it done before Christmas, but everything moves at the speed of cold molasses before Christmas. So, it's very, very close to getting done. We're just kind of dotting the i's and crossing the t's on that package. So, yeah.
But to clarify your expectation, both Pixclara and Zircaix, you still expect to be commercial opportunities within the calendar year?
We do, yeah. And Pixclara, we believe very clear agreement with the FDA on how to move forward. We have the data that we need to satisfy them or the data analysis that they need to be satisfied to move ahead. Unlike the Zircaix, it would be very tempting to, when a company of our size, we submitted three drugs last year, we got one over the line, we had two setbacks. It would be very tempting to ascribe a kind of systematic issue there, but there isn't. They're just completely different. Pixclara was a single CRL topic around data analysis and what the FDA, and by the way, at the stage of labeling, so we're not talking about mid-cycle review or we're talking about at the stage of labeling, all right, where we had a disconnect on how the clinical data manifests itself in the submission.
That single topic issue has been, we believe, resolved in our resubmission. We had no CMC issues. We had no manufacturing-related issues. That package is very straightforward from a regulatory perspective, from a CMC perspective. It's the exact opposite with Zircaix. Zircaix has a gold standard confirmatory phase 3, knocked all 14 primary and secondary endpoints out of the park. The issue is not clinical. The issue is really around manufacturing as a super complicated asset. I dare say we'll probably expect to see, although I don't know that the agency has such an appetite for it these days, but we'll expect to see revised guidance to industry come out of the experience that we had with the FDA because I think it was the first time that somebody really put a full package around a biologic-based radiopharmaceutical in front of them.
And when you have a reviewer that's looking at your product as though it's a cytotoxic ADC, you're going to have some disconnects in terms of understanding. So, I think we certainly feel like we came out of the process with our two setbacks last year, a stronger company. We understand what we're going to have to do differently in the future. We have a much more paranoid lens around how radiopharma is different and not different relative to other, say, biologics. And I think that's a competitive advantage for us to really understand where those issues are with the agency. So, the challenge you have when you're submitting drug approvals is that's the end of the road, and that's where the success happens or it doesn't.
Before I let you go, I do want to ask you one on Alpha, but before I get to that, we still have a couple of minutes. So, just additional opportunities, maybe taking a step back on your existing commercial products. So, you mentioned late last year you had some good phase three data from the study you'd run in China for Illuccix. You said today that's now been filed. Maybe just contextualize that opportunity for us. And also part B of the same question, the BLA process. I mean, moving upstream, you talked about the challenges involved. How near-term and how realistic are those opportunities?
I think they're very realistic. I mean, we see more and more clinical interest in using imaging at the front end of the decision-making process, but no one has really collected the data and made the clinical case yet for doing that, so that's why there have been small academic studies that have done that have shown some promise. We've learned from those studies, and we've built on them. I think our clinical team does a great job of monitoring the state of the art. The bypass studies are really well-designed study that's going to be a label-generating study because we've agreed with the agency that it's a label-generating study, and I think that it enables us to really move upstream from where we are today and impact patients much earlier in the journey. The TAM associated with that is massive.
If we can reduce the number of biopsies down to 200,000-300,000 biopsies a year, we can more or less double the market opportunity for prostate cancer imaging. But it's done in such a way that it's really additive to healthcare. I mean, if you look at the cost, both in terms of the economics of clinical service provision and the morbidity and impact on the patient, that moving upstream is really impactful. It's a no-brainer from an economics perspective. So, I think that's a very bright spot for the company in terms of driving value. I think that when you look at Telix as a company, commercial execution is something that we do really well. That should give you confidence that once we have, for example, Zircaix approved, we'll go back into that same referral physician that we've built a very deep relationship with.
It's going to be a rapid product adoption. I mean, my greatest personal disappointment last year was not getting Zircaix over the line because prescribers are waiting for it. We actually kept our expanded access programs open for Zircaix and Pixclara just to continue to show our commitment to patients. We did that at pretty significant cost to the company. So, we're keeping the enthusiasm alive, but really want to see those two products out in the market. Regarding China and Japan, China is a strategic opportunity that's really about paving the way for therapy. That's the key interest that we have in China as well as our partner interest. Japan is rather different. Japan is probably the second largest homogeneous market for nuclear medicine products. It's got an advanced PET procedure code that's reimbursed at a decent level, not too far behind the U.S.
We see about 110,000-120,000 scan market opportunity in Japan at a good price point. That's well and truly worth prosecuting. It's probably the best opportunity that we have in Asia.
I promised a question on Alpha, if you don't mind, Chris. I'm going to rush you though. So, maybe just 45 seconds on what you think with Alpha-emitting therapies.
Oh, I think it's got great promise. It's just that we probably don't develop them yet in the way that we should. And I think that there's a long way to go on the supply chain before they're viable. But we and others, of course, are working on those.
Great. Thank you very much for your time. Appreciate it.