Telix Pharmaceuticals Limited (TLX) Earnings Call Transcript & Summary

Thank you for standing by, and welcome to the Telix Pharmaceuticals Limited Investor Presentation FY '21 Full Year Results Conference Call. [Operator Instructions] I would now like to hand the conference over to Dr. Christian Behrenbruch, CEO. Please go ahead.

Thanks very much. Good morning to the Australian attendees of this call, and also, good afternoon to the U.S. shareholders which are also joining in. Thanks for the opportunity to present our 2021 year-end presentation and give you an update on the company. Skipping over to Slide 2, which is our standard legal disclaimer and prescribing information for Illuccix. This is the presentation, by the way, that was released to ASX just a few moments ago. Slide 3 illustrates the content that I'm going to cover off today. I'm going to do a sort of a highlight summary of the past 12 months, give you an insight into what the strategic priorities are and direction for the company over the next 12 to 24 months, give you a little bit of a spotlight on Illuccix, and then, very quickly, go through our clinical programs before giving a bit of a summary of what to look forward to as the year progresses. Moving to Slide 4. We have a lot of new shareholders on the register, partially as a consequence of our recent capital raise. So I think it's always useful just to sort of give a snapshot of where the business sits in terms of scale. We are a commercial-stage biopharmaceutical company. We received our first product approval in a major market, that's the U.S. market, late last year for the Illuccix prostate cancer imaging product. We are operating at a commercial scale. So even though we're just in the process of doing our first product commercial launch, we gave over 13,000 patient doses last year, really illustrating, I think, the reach and scale that the company is starting to operate out as a de novo commercial company. We're very clinically active. I'm going to go through our clinical trials a little bit later in this presentation. And all of this activity is underpinned by a manufacturing and supply chain distribution network that is really world-class. And in a sense, this diagram and this level of activity is the combination of our life since we became a public company in 2017. Moving on to Slide #5. Just to summarize the sort of major accomplishments in 2021. I think by any definition, we had a stellar year. Of course, shareholders had moments of patience as we dealt with COVID and regulator delays, but really, in the sort of main of it, we really accomplished everything we expected to in 2021, the Illuccix approval; building out our commercial team, particularly in the U.S., although that is also ongoing in Europe as well; clearly moving ahead our clinical programs; the ZIRCON Phase III trial in renal cancer, very, very near completion of enrollment, much to our delight, given the challenges that we've had in operationalizing that study in COVID; and of course, the breakthrough designation that we received for that very exciting asset. Our therapy programs are progressing nicely across the entire pipeline, and I'll give a summary of that pipeline in a second. And because of the level of interest clinically in our programs, we also have an enormous number of investigator-led studies that are generating fantastic data and clinical insights to the company alongside our main company-sponsored clinical programs. And then last of all, operationally, we've become a much more sophisticated company over the last couple of years, I think, certainly stress tested by COVID but also by necessity as we move towards the commercial stage of delivery. So not just in terms of building that supply chain for first and second and third products but also that long-term view of things like our Seneffe site in Belgium. We finished decommissioning that site and are ready now to build out our manufacturing capability in Europe, where we're a fully vertically integrated business. So I think that stunning accomplishments, really, by the team and a very, very solid platform moving into 2022. Moving on to Slide 6. A high-level financial snapshot of the company. Clearly, our product revenues are very nascent. These are precommercial revenues. So these are not based on any kind of reimbursed or approved products. These are essentially compassionate use and special access product sales, mostly in Europe, and I'll come back and talk a little bit about that in the next slide because I think it's important given some of our recent news flow around our European activities. As everyone will know, we completed a placement a couple of weeks back. We are an extremely well-capitalized company, a balance sheet that will enable us to go through, not just this first product launch, but also through several subsequent product launches and completion of a Phase III therapeutics program. So a very, very important derisk for the company and, frankly, an inflection point for the company that bodes very well for the future. Obviously, I'm well aware, as everybody on this call is, of the challenging market conditions that we're in right now, but my personal view is that life sciences companies in 2022 and 2023 will essentially bifurcate into one of 2 types of companies, the have and the have-not, and that means the balance sheet to be able to weather very volatile conditions, and we are very grateful and very fortunate to have that balance sheet. We have a second half which is also the fact that we are about to launch a product that we believe will make a significant earnings contribution to the company. So from a financial perspective, we're in very, very, very solid shape. Our R&D investment, of course, continues to increase as our program expenditure increases with late-stage studies, and our loss after tax has gone up significantly, reflective of the operationalization of the business going into commercial phase. I think this -- I mean these 4 numbers give you a very clear indication of the direction that we're going. We have a lot of momentum, but we have a lot of firepower to deliver. And I can assure you that the management team has its head down and its bum up prosecuting the great inflection points that we expect to achieve this year. Moving to the next slide. I think it's really important to have an understanding of what our kind of precommercial activity looked like. Clearly, as we transition now to commercial stage in the U.S., we'll be reporting numbers for commercial product sales, which will be very exciting for both the company and for shareholders. But in Europe, we will continue to be making available products under, what's called, magisterial or special access use. And that business continues to grow very nicely, and in fact, as we build out our commercial team in readiness, the effect of that sales and marketing efficacy -- well, not marketing so much because we're actually not -- we're not really marketing a product in Europe, but in terms of making it available and facilitating a process in Europe for kit availability, we're certainly continuing to make good progress. What you can also see is that the effects that we saw in 2020 of COVID waves where there was a real suppression of clinical activity, we're now really moving into an era where the clinical management is better understood in a COVID operating environment. So we're seeing much more consistent growth quarter-on-quarter, and that's something that we also expect to see in other territories where we have commercial activity this year. So despite the delay that we've had in our European marketing authorization, we continue to be commercially active, albeit with certain restrictions, but we continue to be commercially active in Europe, and that certainly fills the gap a little bit in 2022. Moving on to the next slide. In terms of the strategic priorities of the business, there are sort of 4 major goals for the next 24 months. Clearly, the Illuccix program is an important commercial launch pad. It's our entry point to building a relationship with urology and neurologic oncology. That comes in very quickly behind with the renal cancer program and other programs. Then we have multiple revenue stream generation potential. That includes our brain cancer program as well as repurposing the Scintimun product for other markets, including potentially the U.S. market. So we see a layering of multiple revenue streams over the next 18 to 24 months beyond Illuccix, which is, again, an important derisk for the company and an investment that we are fully equipped with our capital raise to be able to make. Our commercial -- our therapeutic programs are really moving into the next stage with ProstACT and ProstACT-related studies progressing very nicely, and over the next 12 to 18 months, the effect of those clinical trials and the data-creation opportunities that they represent are going to be very exciting to share with our shareholders and, of course, our key opinion leaders and patients as well that benefit from that hard work. And then last of all, expanding the pipeline. So we mentioned -- or we disclosed very clearly in our placement documentation that the company takes a view that we're operating on the pipeline that was essentially established about 5 years ago and reaching to the point of maturity, both clinically and commercially. Now we need to think about the future, what does the company's pipeline look like in 5 years from now, and that's not just new imaging agents or new therapeutics, but it's also new platform technologies, production systems and isotopes that are going to be the mainstay of the company's business in the future. So really, that innovation piece now starts to come into the strategic priority list where it perhaps didn't before. Moving on to the next slide. In terms of 2022, clearly, the Illuccix rollout will be a big focal point. We expect that the vast majority of our revenue in the next 12 months will come from the U.S., but of course, we are adding other territories. We do expect other approvals this year, and clearly, we'll launch in Australia as well. It's great to be able to service the home market even if it's a small market. Commercializing our diagnostics portfolio. So over the next 12 to 15 months, we expect to finalize the renal cancer program, and we are already starting to prepare the regulatory pathway for TLX250-CDx, which is our renal cancer imaging agent. It's a really significant market opportunity. It's about half the size of the prostate opportunity with very high unmet medical need and low competition for Telix, and that asset is generating a ton of excitement with the same customer base basically that we are going after with Illuccix. And then we haven't talked so much about our brain cancer imaging program, but we are in the process of finalizing the pathway for the new drug application approval there as well and expect that process to kick off in the next 12 to 18 months or 12 to 15 months as well. In terms of the therapeutic programs, ProstACT is a big focus. I mean that was the driver for our capital raise to get that big clinical trial off the ground, and we're making very good progress towards achieving that. We have 2 Phase II trials running now in kidney cancer combination therapy with immunotherapy, which I'll talk a little bit about later on. And then we expect to get both our brain cancer and our bone marrow conditioning programs well and truly into Phase II studies this year as well. So really a big, big push on the therapeutic programs, and that really reflects the big value inflection point for the company over the next 12 to 18 months. And then manufacturing. I think I've mentioned most of this before, but as I said, the ability to progress now with our build-out of Seneffe is a really important investment for rollout of the product in Europe in the future. The next slide, just to sort of summarize. I'm not going to go through this in individual items, but we really feel that we have the best pipeline of radiopharmaceuticals in the industry. Telix has grown to be recognized as a leading player in the space. And this fantastic set of assets that we have, really, that will enable some very clear commercial and clinical opportunities in the near term. The level of interest that we have from partners and big pharma collaborators is growing on a weekly basis, and it's very much reflected in our organizational growth over the last 12 months. And so we expect a lot of exciting news flow over the next 12 months as our pipeline continues to emerge. Moving past Slide 11. I'm going to spend a little bit of time now talking about our Illuccix launch. I know this is a topic of intense interest. And we thought we'd put together Slide 12 for you, which is a little kind of road map of activity. A product launch isn't a singular temporal event. It's an event horizon or a time line that has a lot of different moving parts to it. Some of it are things that shareholders have come to understand fairly well like the timing of those reimbursement codes, which we essentially have in 2 waves, which is, first, the HCPCS code and then the pass-through code, which is for hospital outpatient use. That sort of comes in 2 waves, first at the beginning of April and then at the beginning of July. We also have the operationalization of the launch. So we currently have 117 pharmacies contracted. Those are the pharmacies that will be available at the time of first commercial product, which will happen around the end of next month or very early in April. We are just finalizing the inventory right now that's going out to all those nuclear pharmacies. So a very busy, busy time for the company. In fact, I'm here in the U.S. right now for a 6-month period to make sure that all of our operational and sales objectives are faithfully executed. And then in parallel to that, we have 2 major conferences. We've just had the ASCO GU conference, which is the primary genitourinary conference where we had just a fantastic amount of clinician interest in what we're doing. And then you've got the AUA meeting in May, which is a very important commercial launch point as well. And then we expand our network as well. So we expect that in the second half of this year that we'll add another 30 to 50 nuclear pharmacies, really making sure that we get that last mile of coverage in the United States for our product. So this is a very ambitious and very exciting time for the company. I can tell you that our launch is going very well, and I'm looking forward to providing those commercial updates as they come to life. Certainly, our partners, Pharmalogic and Cardinal Health and some of the other smaller pharmacies and pharmacy networks, have been fantastic to work with during this launch period. Moving on to Slide 13. Just to summarize or to reiterate our differentiation. We have 3 things that are going for our products compared to our competition. The first is access. The second is really that on-demand major scheduling flexibility. And the third is the strength of our partnership sites in terms of reaching that last mile of service in the United States. I can tell you that to date, we have qualified 680 imaging centers. Those are 680 imaging centers ahead of commercial launch that want to use our product, and we'll be in a position to order doses when we go live. So we've got a huge pent-up demand waiting for this product, and it's certainly generating a lot of excitement in our U.S. commercial team. I think we've done a terrific job, frankly, of preparing the market for this launch. In terms of pricing structure, next slide. Don't be distracted by the shiny vials, although it's really gratifying to see what a final release -- picture of a final release product would like. Our U.S. pricing structure, our reimbursement structure is expected to be published on the 1st of March. It will be in line with prior investor guidance of between $4,000 and $5,000 per dose, and obviously, that information will be made available when it is disclosed into the public domain. We're expecting our dose to be a 5 millicuries dose as a standardized dose, although the way that the Illuccix product is set up from a prescribing perspective, we have a lot of flexibility in the way in which we dose the patient, and that's very much deliberate because unlike our competition, we don't believe that one dose -- one size fits all. We want to optimize image quality and dosimetry for the patient, and we really empower the physician to do that. And so we have a pricing structure that reflects that, and I think it's very well aligned with our commercial objectives. So yes, an exciting time in terms of getting to the pointy end of the financials of what Illuccix will look like as it goes into the commercial phase. Moving along to the clinical program. So I'm going to go through this fairly quickly, just to kind of give a progress snapshot. Our prostate cancer therapy program is clearly the big focal point. The ProstACT selection of studies, which includes the Phase III global study as well as 2 other specialist studies that are designed to produce important ancillary information around the ProstACT global study. That's clearly the investment focus. We do have a second-generation program that's in early development -- early clinical development, where we're getting some really exciting data. But I think the key focus clearly is on the TLX591 and the ProstACT programs. In terms of the strategy and our differentiated approach, it's clear that we are generating a ton of interest from key opinion leaders because they understand how different this product is from our competitor. It's a very efficient delivery of radiation. We inject far less radiation into the patient. We have a dosing regimen, which is really medical oncology friendly. The purpose of this product is to maximize the amount of time that a patient spends with medical oncology, which is really where the mainstay of the therapy for a prostate cancer patient lies. And so we think we have a very efficient way of delivering targeted radiation and, as I said, a ton of interest from the investigators that we're pulling together on the ProstACT study. So we are in the process of getting our ProstACT trial up and running in Australia. We started dosing first patients already. We've also started to make patient doses available under compassionate use in Australia, and we'll be expanding that practice and site extensions into the U.S. and Europe over the coming -- remainder of this half. And obviously, that's subject to regulatory approvals and so forth but making very good progress on this overall program. And I think the ProstACT SELECT and the ProstACT TARGET study give us the opportunity to generate data and share our progress with the market as our Phase III continues. So don't expect that this will be a black box in terms of news flow. Moving to the next slide. Just a brief comment about our next-generation technology. You'll see more and more commentary from the radiopharmaceutical world about "alpha therapy." These are radionuclides that have very high energy but very localized sort of damaging effects and do a much better job of sparing healthy tissues. We've engineered, as part of our life cycle management for our prostate cancer program, a second-generation product, which is now in human studies, and this is really about Telix reinforcing its leadership in urologic oncology. It's about making sure that we have a depth of pipeline for the long term and very complementary to what we're doing with TLX591. So it's great to see that life cycle management planning already starting to happen within the company. Moving to the next slide. In terms of the CA9 or the renal cancer program, again, an imaging and a therapeutic candidate. I've mentioned the status of the ZIRCON trial and its imminent completion of recruitment probably in the next month, and that will result in a readout around the middle of the year. And clearly, that's the company's first fully baked internal product in terms of the Phase III trial, so a very significant commercial and clinical milestone for the company. As I also mentioned, we have 2 Phase II trials running right now at Memorial Sloan Kettering and another site in the United States. These are combination therapies with our combination studies with immunotherapy. Really exciting to be able to have these studies finally away, and when the second IRB approval is finished, then we'll be talking more about these studies and what their clinical objectives are. If you move on to the next slide, basically, the concept of these assets is to essentially deliver additional efficacy to immunotherapies. And what we've learned over the last couple of years is that when you have a high expression of carbonic anhydrase 9, which is the target that these assets hit. When you deliver radiation, you have the potential to essentially change the tumor resistance to immunotherapy in a very positive way for the patient. It seems to deliver excellent results in nonclinical studies, and so it will be exciting to see what happens when we observe this approach in patients. So yes, really, really scientifically interesting program. And if it's successful, if we really can prime the pump of immunotherapies, it's a really significant addition to what's become the most dominant area or dominant new modality in cancer care. So it's a big deal for the company. We disclosed last year the progress we made with our brain cancer program. As I've mentioned in my earlier comments, we expect to progress an NDA this year or early next year for the imaging part of that. Brain cancer imaging and the treatment of glioblastoma is very much a repeat imaging activity. And so it's a 50,000- to 60,000-dose opportunity in the U.S. and at sort of a similar price point to Illuccix. So we feel like it's a commercial opportunity that really, really fits the Telix model well. Following in behind that, of course, is therapy program like all of our disease areas. We've got nice results last year in our Phase I trial, clear evidence of antitumor effect from imaging. We've been able to move from a refractory or a reoccurrent disease state into a frontline care concept. And so we are expecting in the next couple of months to start dosing patients initially in the Phase I trial for frontline glioblastoma that will move very, very quickly into a Phase II study. So that ethics approval is expected very shortly. This is actually really my favorite program in the company, and I'm really looking forward to getting to the end of this year, early next year where we have enough data to be able to make decisions about what a pivotal study may look like. I'm not going to really go into any more detail on Slide 22, except for the fact that we're moving very quickly towards this being our third product filing. Moving on to Slide 24. Our bone marrow conditioning program. Again, this was the acquisition of TheraPharm and brought on board a new asset for targeting CD66, both as an imaging agent and a therapy. The imaging agent already has a marketing authorization in a number of countries in Europe and abroad. We are in the process of evaluating the suitability of taking that package to the U.S., and we expect to have some consultations with the FDA around the middle of the year for that. We're preparing those consultations now. We had nice data come out of the Phase I trial in light chain amyloidosis, and we're in the process, again, of preparing for some European scientific consultations about expanding that clinical activity into later-stage and potentially a pivotal trial. I think it's fair to say that this program is probably the slower-moving program right now. We're in the process of manufacturing material for new clinical studies, which will take a good proportion of this year. But you'll still expect to see regulatory progress on this asset over the course of the year, and we are supporting some investigator-led studies. So we have a pediatric cancer study that's just about to start at Great Ormond Street Hospital in London and certainly lots of opportunities for collaboration around this asset, which is exciting to see. All right. Moving through Slide 25 into R&D. Because of the fact that research and innovation was a part of our placement narrative, I thought it would be a good idea to give you a bit more of a sense of some of the things that we're working on for the future. Slide 26 shows the 5 major areas that we are kind of focused on. I've mentioned targeted alpha therapy already in the context of TLX592. So this is about developing assets really for the next-generation pipeline. The combination work that we're doing with immuno-oncology, that's a general research theme. And of course, we have clinical trials like the STARLITE studies, which are showing this in patients, but we also have other nonclinical research activities going on in parallel, and this is really understanding that whole concept of how does radiation interact with immunotherapy. Closely related to that is the tumor microenvironment. So this is about how do we interrogate a cancer and optimize the therapeutic strategy behind it, and this is a super exciting area of research. It's one that's driven by a lot of our pharma R&D collaborations, and as I'll show you in a second, we have some spectacular tools for coming up with totally different ways of managing the patient really when it comes to their cancer microenvironment or the tumor microenvironment. We have an active program in artificial intelligence. We hired a VP of AI and Big Data this year. That person's responsibility is to come up with software tools and clinical applications that support our imaging and to link imaging to therapy, and we fully expect to establish and develop products to support that, including regulatory approved products. So that's an exciting area of collaboration for the company. And then last of all, in radioguided surgery. So many of you appreciate Illuccix is a product that's very much targeted at staging the TLX250-CDx program. Again, it's a very much a surgically directed imaging modality. And we are going to spend more and more R&D energy asking a question, "How can we bring molecular imaging into the operating theater?" You can do that with PET, and you can detect -- and spec, and we can detect the radionuclide emissions in the OR or we can couple it with fluorescently guided tracers where you get both imaging and optical fluorescent imaging in the OR during the intraoperative process. So again, this is about expanding some of the technology platforms that Telix has invested in already. Just to give you a few little cameos on this -- on Slide 27. Our relationship with Merck Group expanded significantly last year. We're getting ready to run clinical trials, actually, 2 clinical trials this year in combination with an oral DNA damage repair inhibitor. We think that our approach to tackling this is unique because of the way that antibodies residualize radiation in tumors. And essentially, we've been able to show that very, very low-dose radiation that we were able to achieve very impressive treatment response in animal models. Of course, we'll be publishing those outcomes this year, and we are gearing up right now preparing all of the documentation to run combination clinical trial, which will hopefully start early in the second half of next year. That is really exciting, cutting-edge science, and obviously, it's great to be running clinical trials in combination with other very promising big pharma assets. I mentioned the radioguided surgery. We have 2 major collaborations, one with Lightpoint Medical, which is really about how do you resect the patient using a radiation guidance in the operating theater. And then the sort of competing concepts is our collaboration with Mauna Kea. We're sort of covering off the bases here, which is really about the optical of the fluorescent imaging. So how do you actually use -- how do you use targeted imaging agents with fluorophores to do a better job at resecting a patient in the OR. These are really huge market opportunities. They speak to the full of the physicians that we engage with on urological oncology. It's a very rapidly growing area, very rapidly growing field and one that we believe we can play a dominant role in, particularly through high-quality partnerships. So yes, very exciting R&D area for the company. And then last of all, I mentioned the tumor microenvironment, and it's kind of a busy slide, but the exciting part is probably the diagram. What it really shows is that when you look at Telix's pipeline, including some of the very early research assets that we in-licensed last year, what you can see is that we have a whole selection of tracers that can interrogate different parts of that tumor microenvironment. They can measure oxygenation. They can look at whether a cell is dying. They can look at how fast the cell is growing. We can see whether the tumor is immune compromise. We can see whether there's new blood vessels growing. And so part of the long-term vision of our pipeline is that we are building a tool set that really helps you to understand exactly what is the functional state of that tumor. And it's my personal view that there's no other company that is looking at this the way that Telix is, and our pipeline is really unique in its ability to interrogate that. So yes, just to sort of give you a little bit of a vision of how we see the future unfolding for the company and the expansion of the indications that our pipeline can potentially deliver. So looking forward, moving to Slide 31. I love this slide, and it sort of evolved from the presentation that we gave last year. I was really showing the full landscape of studies that we have ongoing in the company. Clearly, there's a focus on urological oncology and neuro-oncology, but we are starting to look at other parts of the body as well. And the bottom line is that our mission is to change the way in which radiation oncology is delivered and to make it a tool that's accessible to medical oncology. That's our fundamental mission as a company. And so I'd say that the level of clinical activity and the breadth of our clinical programs is something that is really capturing both clinical and commercial attention. And last year, we started to see some of the fruits of this effort. This year, as we pivot more towards the therapeutic pipeline focus, we're really going to see exciting data come out across our therapy programs as well. So finally, just to wrap up. In terms of what you can expect to see this year, and I know I say it every year, but this year, 2022 is going to be the biggest year ever for Telix, again, notwithstanding the market conditions, our capital raise really puts us in an incredibly strong position. There's a lot happening in Q1 and Q2 with respect to both the commercialization of our lead program as well as completing the ZIRCON trial and getting some of our therapeutic trials up and running. So you can expect lots of news flow and commercially important inflection points. I'm particularly excited to complete the ZIRCON trial. It's just an amazing accomplishment for the company and one that I think will generate a lot of value for shareholders in the short to medium term. In the second half of the year, it's really about going full speed on all of the global sites for ProstACT. We will certainly be in the hot zone for our BLA filing for TLX250-CDx. So that will be our second product seeking regulatory approval and also similarly for the brain cancer program. So you also should expect that in the second half to get really a much clearer insight into how the commercial performance of Illuccix is faring because we will have all of the reimbursement requirements underpinning that commercial success behind us, and it will be full systems go on the Illuccix launch. So I'll wrap it up there and throw it over to questions. I appreciate the attention. And I'll throw it to the floor for any questions or comments.

[Operator Instructions] The first question today comes from Vanessa Thomson from Jefferies.

Christian, I just wanted to ask about lutetium and the supply dynamics there in terms of amounts being produced compared to that, that's required in the near term and how you expect this is going to change going forward.

Yes. Thanks very much. Lutetium is an isotope, we don't see a supply chain problem with. We -- I think we have 6 or 7 suppliers of commercial- and clinical-grade lutetium that are qualified, which certainly more than meets our needs. As a business, we also have established an insurance policy, which is our Seneffe site. You have an enormous lutetium license there and the technological capability to process our own lutetium if it's required. We're not in the isotope business, and we never will get into the isotope business, but we obviously look at -- and I think the market is well educated now that supply chain robustness and efficiency is really important. So we're in very good shape vis-a-vis lutetium, zirconium, similarly, gallium. We put an enormous amount of work in the gallium for our market launch for Illuccix. The one that's a little more speculative for the future is actinium. We are also looking at ways of being a more significant actor in that space, but it's still very early-stage isotope, and it's not yet commercially sort of a slam dunk. I hope that answers your question.

The next question comes from Dennis Hulme from Taylor Collison.

Chris, you've highlighted your extensive pipeline of products and development. Can you give us some color about how much you expect to be spending on R&D over the next few years?

Sure. Well, I mean, we haven't given sort of an R&D forecast beyond of what we sort of put in the placement documentation. But I think it's the nature of the R&D probably changes. We're doing -- historically, we've done mostly small R and big D. So we've been focused on asset manufacturing development and then also our clinical trials. I would expect we -- our external R&D expenditure was about $35 million last year. I expect that sort of rate to continue, that sort of trend to continue. And we expect over the next 3 years to invest around $50 million to $60 million on innovation. Obviously, that exact expenditure will depend a little bit on our earnings. It will depend a little bit on how we see the competitive landscape unfolding. But certainly, where we've traditionally done very little basic new innovation, that will sort of start to change over the next few years, next year maybe of the order of $10 million to $15 million in that sort of new innovation space. And clearly, if we have the earnings profile to warrant it, we can do more, but I think our shareholders are mostly expecting to see our balance sheet being used to commercialize the near-term assets that we have at hand. Does that make sense?

Yes, it does. If I can just clarify, that $50 million to $60 million on innovation in a few years' time, would that be in addition to that $35 million in external R&D? Or would that include that $35 million?

No. No. That would be in addition.

Right. Okay. And if I could just move on to TLX101-CDx. It sounds like a very exciting product. Can you just talk us through, I guess, the steps that you'll need to complete in order to file an NDA, what data you'll be relying on or what data you might need to collect before you can do that filing?

Look, we're not really giving guidance on that yet because it's commercially sensitive. We would like to clarify a few things with the FDA before we talk with a bit more clarity about the time lines. We certainly have experience in running a regulatory process that's suitable for that type of a product. So I think we kind of know what needs to be done. We have a lot of great clinical data that we've obtained either directly or in partnership. We have also a drug master file already filed on that agent. So we are getting experience with it on a regular basis, although that drug master file is certainly not, at this stage, yet where it needs to be for a commercial product. So I think we'll be certainly talking more about that as we get some dialogue moving with the FDA. It has an orphan designation, so that certainly makes the dialogue with regulators easier, and I look forward to giving some more updates on that probably in the early half or the second half of this year, early part of the second half of this year.

[Operator Instructions] Moving to the webcast. [ Peter Linas ] would like to ask how does Illuccix differ from existing PSMA imaging agents?"

Well, it's a very kind of an open-ended question, but I think there's only 2 commercially available products in the U.S. right now, and they are medically equivalent. However, their availability and their supply chain and certainly, their acceptability to users is very, very different. Our major advantage is that our product is made available under a practice of pharmacy distribution network rather than a GMP or a drug manufacturing network, which means that the scheduling flexibility of accessing our product is really superior. We have a very different cost of goods profile as well, which gives us a lot of commercial flexibility. But in a sense -- in essence, they are medically equivalent, but the way in which we make the product available to the market is very much night and day. And we think that we have a significant commercial advantage in the fact that our product will be available from 7:00 in the morning until 8:00 at night, and you can order it when you need it. It's a really big advantage. That's probably -- without taking an hour-long discussion about the nuances of it, I think that's probably the major differentiation.

[Operator Instructions] At this time, we're showing no further questions, I'll hand the conference back to Mr. Behrenbruch for closing remarks.

Well, look, thank you very much. I appreciate the opportunity to give you this update, and we have a number of other brokered reaching over the course of the next couple of days. Welcome the opportunity for reach-out and further questions, and wish you a pleasant afternoon or early evening here from Indianapolis. Thanks for your time.